Transcatheter aortic valve implantation: a revolution in the therapy of elderly and high-risk patients with severe aortic stenosis

PubMed Central

Kilic, Teoman; Yilmaz, Irem

2017-01-01

Transcatheter aortic valve implantation (TAVI) represents a real revolution in the field of interventional cardiology for the treatment of elderly or high-risk surgical patients with severe symptomatic aortic valve stenosis. Today, TAVI seems to play a key and a reliable role in the treatment of intermediate and maybe low-risk patients with severe aortic stenosis. TAVI has also evolved from a complex and hazardous procedure into an effective and safe therapy by the development of new generation devices. This article aims to review the background and future of TAVI, clinical trials and registries with old and new generation TAVI devices and to focus on some open issues related to post-procedural outcomes. PMID:28408919

Effect of tricuspid regurgitation and the right heart on survival after transcatheter aortic valve replacement: insights from the Placement of Aortic Transcatheter Valves II inoperable cohort.

PubMed

Lindman, Brian R; Maniar, Hersh S; Jaber, Wael A; Lerakis, Stamatios; Mack, Michael J; Suri, Rakesh M; Thourani, Vinod H; Babaliaros, Vasilis; Kereiakes, Dean J; Whisenant, Brian; Miller, D Craig; Tuzcu, E Murat; Svensson, Lars G; Xu, Ke; Doshi, Darshan; Leon, Martin B; Zajarias, Alan

2015-04-01

Tricuspid regurgitation (TR) and right ventricular (RV) dysfunction adversely affect outcomes in patients with heart failure or mitral valve disease, but their impact on outcomes in patients with aortic stenosis treated with transcatheter aortic valve replacement has not been well characterized. Among 542 patients with symptomatic aortic stenosis treated in the Placement of Aortic Transcatheter Valves (PARTNER) II trial (inoperable cohort) with a Sapien or Sapien XT valve via a transfemoral approach, baseline TR severity, right atrial and RV size and RV function were evaluated by echocardiography according to established guidelines. One-year mortality was 16.9%, 17.2%, 32.6%, and 61.1% for patients with no/trace (n=167), mild (n=205), moderate (n=117), and severe (n=18) TR, respectively (P<0.001). Increasing severity of RV dysfunction as well as right atrial and RV enlargement were also associated with increased mortality (P<0.001). After multivariable adjustment, severe TR (hazard ratio, 3.20; 95% confidence interval, 1.50-6.82; P=0.003) and moderate TR (hazard ratio, 1.60; 95% confidence interval, 1.02-2.52; P=0.042) remained associated with increased mortality as did right atrial and RV enlargement, but not RV dysfunction. There was an interaction between TR and mitral regurgitation severity (P=0.04); the increased hazard of death associated with moderate/severe TR only occurred in those with no/trace/mild mitral regurgitation. In inoperable patients treated with transcatheter aortic valve replacement, moderate or severe TR and right heart enlargement are independently associated with increased 1-year mortality; however, the association between moderate or severe TR and an increased hazard of death was only found in those with minimal mitral regurgitation at baseline. These findings may improve our assessment of anticipated benefit from transcatheter aortic valve replacement and support the need for future studies on TR and the right heart, including whether

Transcatheter aortic valve implantation in patients with bicuspid aortic valve stenosis.

PubMed

Wijesinghe, Namal; Ye, Jian; Rodés-Cabau, Josep; Cheung, Anson; Velianou, James L; Natarajan, Madhu K; Dumont, Eric; Nietlispach, Fabian; Gurvitch, Ronen; Wood, David A; Tay, Edgar; Webb, John G

2010-11-01

We evaluated transcatheter aortic valve implantation (TAVI) in high-risk patients with bicuspid aortic valve (BAV) stenosis. TAVI shows promise in the treatment of severe stenosis of triscupid aortic valves, especially in high-risk patients. However, BAV stenosis has been considered a contraindication to TAVI. Eleven patients (age 52 to 90 years) with symptomatic severe BAV stenosis underwent TAVI at 3 Canadian tertiary hospitals between May 2006 and April 2010. All patients were considered high risk for surgical aortic valve replacement. Edwards-SAPIEN transcatheter heart valves (Edwards Lifesciences, Inc., Irvine, California) were used. Transfemoral or transapical access was selected, depending on the adequacy of femoral access. Access was transfemoral in 7 patients and transapical in 4 patients. There were no intraprocedural complications. Significant symptomatic and hemodynamic improvement was observed in 10 of 11 patients. Baseline aortic valve area of 0.65 ± 0.17 cm(2) and mean transaortic pressure gradient of 41 ± 22.4 mm Hg were improved to 1.45 ± 0.3 cm(2) and 13.4 ± 5.7 mm Hg, respectively. Two patients had moderate perivalvular leaks. At the 30-day follow-up there were 2 deaths due to multisystem failure in 2 transapical patients. In 1 patient an undersized, suboptimally positioned, unstable valve required late conversion to open surgery. TAVI in selected high-risk patients with severe BAV stenosis can be successfully performed with acceptable clinical outcomes but will require further evaluation. Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Transapical implantation of a second-generation transcatheter heart valve in patients with noncalcified aortic regurgitation.

PubMed

Seiffert, Moritz; Diemert, Patrick; Koschyk, Dietmar; Schirmer, Johannes; Conradi, Lenard; Schnabel, Renate; Blankenberg, Stefan; Reichenspurner, Hermann; Baldus, Stephan; Treede, Hendrik

2013-06-01

This study sought to report on the feasibility and early results of transcatheter aortic valve implantation employing a second-generation device in a series of patients with pure aortic regurgitation. Efficacy and safety of transcatheter aortic valve implantation in patients with calcific aortic stenosis and high surgical risk has been demonstrated. However, experience with implantation for severe noncalcified aortic regurgitation has been limited due to increased risk for valve dislocation or annular rupture. Five patients (mean age: 66.6 ± 7 years) underwent transapical implantation of a JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for moderate to severe, noncalcified aortic regurgitation. All patients were considered high risk for surgical aortic valve replacement after evaluation by an interdisciplinary heart team (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] range 3.1% to 38.9%). Procedural and acute clinical outcomes were analyzed. Implantation was successful in all cases without relevant remaining aortic regurgitation or signs of stenosis in any of the patients. No major device- or procedure-related adverse events occurred and all 5 patients were alive with improved exercise tolerance at 3-month follow-up. Noncalcified aortic regurgitation continues to be a challenging pathology for transcatheter aortic valve implantation due to the risk for insufficient anchoring of the valve stent within the aortic annulus. This report provides first evidence that the JenaValve prosthesis may be a reasonable option in these specific patients due to its unique stent design, clipping the native aortic valve leaflets, and offering promising early results. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Atrioventricular and intraventricular block after transcatheter aortic valve implantation.

PubMed

Lee, Jane J; Goldschlager, Nora; Mahadevan, Vaikom S

2018-06-24

Aortic stenosis is the most common valvular heart disease in industrialized countries and the most common cause of left ventricular outflow tract (LVOT) obstruction. Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement for intermediate to high-risk surgical candidates with symptomatic severe aortic stenosis. Conduction system abnormalities, including atrioventricular (AV) and intraventricular (IV) block, are the most common complication of TAVR. In this review, we aim to explore the anatomical issues relevant to atrioventricular block, the relevant clinical and procedural aspects, and the management and long-term implications of AV and IV block.

Longitudinal Hemodynamics of Transcatheter and Surgical Aortic Valves in the PARTNER Trial.

PubMed

Douglas, Pamela S; Leon, Martin B; Mack, Michael J; Svensson, Lars G; Webb, John G; Hahn, Rebecca T; Pibarot, Philippe; Weissman, Neil J; Miller, D Craig; Kapadia, Samir; Herrmann, Howard C; Kodali, Susheel K; Makkar, Raj R; Thourani, Vinod H; Lerakis, Stamatios; Lowry, Ashley M; Rajeswaran, Jeevanantham; Finn, Matthew T; Alu, Maria C; Smith, Craig R; Blackstone, Eugene H

2017-11-01

Use of transcatheter aortic valve replacement (TAVR) for severe aortic stenosis is growing rapidly. However, to our knowledge, the durability of these prostheses is incompletely defined. To determine the midterm hemodynamic performance of balloon-expandable transcatheter heart valves. In this study, we analyzed core laboratory-generated data from echocardiograms of all patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 1 Trial with successful TAVR or surgical AVR (SAVR) obtained preimplantation and at 7 days, 1 and 6 months, and 1, 2, 3, 4, and 5 years postimplantation. Patients from continued access observational studies were included for comparison. Successful implantation after randomization to TAVR vs SAVR (PARTNER 1A; TAVR, n = 321; SAVR, n = 313), TAVR vs medical treatment (PARTNER 1B; TAVR, n = 165), and continued access (TAVR, n = 1996). Five-year echocardiogram data were available for 424 patients after TAVR and 49 after SAVR. Death or reintervention for aortic valve structural indications, measured using aortic valve mean gradient, effective orifice area, Doppler velocity index, and evidence of hemodynamic deterioration by reintervention, adverse hemodynamics, or transvalvular regurgitation. Of 2795 included patients, the mean (SD) age was 84.5 (7.1) years, and 1313 (47.0%) were female. Population hemodynamic trends derived from nonlinear mixed-effects models showed small early favorable changes in the first few months post-TAVR, with a decrease of -2.9 mm Hg in aortic valve mean gradient, an increase of 0.028 in Doppler velocity index, and an increase of 0.09 cm2 in effective orifice area. There was relative stability at a median follow-up of 3.1 (maximum, 5) years. Moderate/severe transvalvular regurgitation was noted in 89 patients (3.7%) after TAVR and increased over time. Patients with SAVR showed no significant changes. In TAVR, death/reintervention was associated with lower ejection fraction, stroke volume

Percutaneous closure of acute aorto-right ventricular fistula following transcatheter bicuspid aortic valve replacement.

PubMed

Nakamura, Kenta; Passeri, Jonathan J; Inglessis-Azuaje, Ignacio

2017-07-01

We report a case of acute aorto-right ventricular fistula following transcatheter bicuspid aortic valve replacement and subsequent percutaneous closure. The diagnosis and treatment of this rare complication is illustrated through multi-modality imaging. We hypothesize that the patient's heavily calcified bicuspid aortic valve anatomy led to asymmetric deployment of the transcatheter aortic valve replacement (TAVR) prosthesis, traumatizing the right sinus of Valsalva at the distal edge of the TAVR stent and ultimately fistulized to the right ventricle. The patient acutely decompensated with heart failure five days after TAVR and underwent emergent intervention. The aorto-right ventricular fistula was closed using an 18-mm septal occluder device with marked clinical recovery. Transcatheter closure is a viable treatment option for acute aorto-right ventricular fistula. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Left main coronary artery obstruction by dislodged native-valve calculus after transcatheter aortic valve replacement.

PubMed

Durmaz, Tahir; Ayhan, Huseyin; Keles, Telat; Aslan, Abdullah Nabi; Erdogan, Kemal Esref; Sari, Cenk; Bilen, Emine; Akcay, Murat; Bozkurt, Engin

2014-08-01

Transcatheter aortic valve replacement can be an effective, reliable treatment for severe aortic stenosis in surgically high-risk or ineligible patients. However, various sequelae like coronary artery obstruction can occur, not only in the long term, but also immediately after the procedure. We present the case of a 78-year-old woman whose left main coronary artery became obstructed with calculus 2 hours after the transfemoral implantation of an Edwards Sapien XT aortic valve. Despite percutaneous coronary intervention in that artery, the patient died. This case reminds us that early recognition of acute coronary obstruction and prompt intervention are crucial in patients with aortic stenosis who have undergone transcatheter aortic valve replacement.

Left Main Coronary Artery Obstruction by Dislodged Native-Valve Calculus after Transcatheter Aortic Valve Replacement

PubMed Central

Durmaz, Tahir; Keles, Telat; Aslan, Abdullah Nabi; Erdogan, Kemal Esref; Sari, Cenk; Bilen, Emine; Akcay, Murat; Bozkurt, Engin

2014-01-01

Transcatheter aortic valve replacement can be an effective, reliable treatment for severe aortic stenosis in surgically high-risk or ineligible patients. However, various sequelae like coronary artery obstruction can occur, not only in the long term, but also immediately after the procedure. We present the case of a 78-year-old woman whose left main coronary artery became obstructed with calculus 2 hours after the transfemoral implantation of an Edwards Sapien XT aortic valve. Despite percutaneous coronary intervention in that artery, the patient died. This case reminds us that early recognition of acute coronary obstruction and prompt intervention are crucial in patients with aortic stenosis who have undergone transcatheter aortic valve replacement. PMID:25120396

[Selection of patients for transcatheter aortic valve implantation].

PubMed

Tron, Christophe; Godin, Matthieu; Litzler, Pierre-Yves; Bauer, Fabrice; Caudron, Jérome; Dacher, Jean-Nicolas; Borz, Bogdan; Canville, Alexandre; Kurtz, Baptiste; Bessou, Jean-Paul; Cribier, Alain; Eltchaninoff, Hélène

2012-06-01

A good selection of patients is a crucial step before transcatheter aortic valve implantation (TAVI) in order to select the good indications and choose the access route. TAVI should be considered only in patients with symptomatic severe aortic stenosis and either contraindication or high surgical risk. Indication for TAVI should be discussed in a multidisciplinary team meeting. Echocardiography and/or CT scan are mandatory to evaluate the aortic annulus size and select the good prosthesis size. The possibility of transfemoral implantation is evaluated by angiography and CT scan, and based on the arterial diameters, but also on the presence of tortuosities and arterial calcifications. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Transcatheter Aortic Valve Implantation: Experience with the CoreValve Device.

PubMed

Asgar, Anita W; Bonan, Raoul

2012-01-01

The field of transcatheter aortic valve implantation has been rapidly evolving. The Medtronic CoreValve first emerged on the landscape in 2004 with initial first human studies, and it is currently being studied in the Pivotal US trial. This article details the current experience with the self-expanding aortic valve with a focus on clinical results and ongoing challenges. Copyright © 2012 Elsevier Inc. All rights reserved.

How to Perform Transcaval Access and Closure for Transcatheter Aortic Valve Implantation

PubMed Central

Lederman, Robert J.; Babaliaros, Vasilis C.; Greenbaum, Adam B.

2016-01-01

Transcaval, or caval-aortic, access is a promising approach for fully percutaneous trans-catheter aortic valve implantation in patients without good conventional access options. This tutorial review provides step-by-step guidance to planning and executing the procedure, along with approaches to remedy complications. PMID:26356244

Prevalence and Prognostic Significance of Right Ventricular Systolic Dysfunction in Patients Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Lindsay, Alistair C; Harron, Katie; Jabbour, Richard J; Kanyal, Ritesh; Snow, Thomas M; Sawhney, Paramvir; Alpendurada, Francisco; Roughton, Michael; Pennell, Dudley J; Duncan, Alison; Di Mario, Carlo; Davies, Simon W; Mohiaddin, Raad H; Moat, Neil E

2016-07-01

Cardiovascular magnetic resonance (CMR) can provide important structural information in patients undergoing transcatheter aortic valve implantation. Although CMR is considered the standard of reference for measuring ventricular volumes and mass, the relationship between CMR findings of right ventricular (RV) function and outcomes after transcatheter aortic valve implantation has not previously been reported. A total of 190 patients underwent 1.5 Tesla CMR before transcatheter aortic valve implantation. Steady-state free precession sequences were used for aortic valve planimetry and to assess ventricular volumes and mass. Semiautomated image analysis was performed by 2 specialist reviewers blinded to patient treatment. Patient follow-up was obtained from the Office of National Statistics mortality database. The median age was 81.0 (interquartile range, 74.9-85.5) years; 50.0% were women. Impaired RV function (RV ejection fraction ≤50%) was present in 45 (23.7%) patients. Patients with RV dysfunction had poorer left ventricular ejection fractions (42% versus 69%), higher indexed left ventricular end-systolic volumes (96 versus 40 mL), and greater indexed left ventricular mass (101 versus 85 g/m(2); P<0.01 for all) than those with normal RV function. Median follow-up was 850 days; 21 of 45 (46.7%) patients with RV dysfunction died, compared with 43 of 145 (29.7%) patients with normal RV function (P=0.035). After adjustment for significant baseline variables, both RV ejection fraction ≤50% (hazard ratio, 2.12; P=0.017) and indexed aortic valve area (hazard ratio, 4.16; P=0.025) were independently associated with survival. RV function, measured on preprocedural CMR, is an independent predictor of mortality after transcatheter aortic valve implantation. CMR assessment of RV function may be important in the risk stratification of patients undergoing transcatheter aortic valve implantation. © 2016 American Heart Association, Inc.

Association of CKD with Outcomes Among Patients Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Lüders, Florian; Kaier, Klaus; Kaleschke, Gerrit; Gebauer, Katrin; Meyborg, Matthias; Malyar, Nasser M; Freisinger, Eva; Baumgartner, Helmut; Reinecke, Holger; Reinöhl, Jochen

2017-05-08

Despitethe multiple depicted associations of CKD with reduced cardiovascular and overall prognoses, the association of CKD with outcome of patients undergoing transcatheter aortic valve implantation has still not been well described. Data from all hospitalized patients who underwent transcatheter aortic valve implantation procedures between January 1, 2010 and December 31, 2013 in Germany were evaluated regarding influence of CKD, even in the earlier stages, on morbidity, in-hospital outcomes, and costs. A total of 28,716 patients were treated with transcatheter aortic valve implantation. A total of 11,189 (39.0%) suffered from CKD. Patients with CKD were predominantly women; had higher rates of comorbidities, such as coronary artery disease, heart failure at New York Heart Association 3/4, peripheral artery disease, and diabetes; and had a 1.3-fold higher estimated logistic European System for Cardiac Operative Risk Evaluation value. In-hospital mortality was independently associated with CKD stage ≥3 (up to odds ratio, 1.71; 95% confidence interval, 1.35 to 2.17; P <0.05), bleeding was independently associated with CKD stage ≥4 (up to odds ratio, 1.82; 95% confidence interval, 1.47 to 2.24; P <0.001), and AKI was independently associated with CKD stages 3 (odds ratio, 1.83; 95% confidence interval, 1.62 to 2.06) and 4 (odds ratio, 2.33; 95% confidence interval, 1.92 to 2.83 both P <0.001). The stroke risk, in contrast, was lower for patients with CKD stages 4 (odds ratio, 0.23; 95% confidence interval, 0.16 to 0.33) and 5 (odds ratio, 0.24; 95% confidence interval, 0.15 to 0.39; both P <0.001). Lengths of hospital stay were, on average, 1.2-fold longer, whereas reimbursements were, on average, only 1.03-fold higher in patients who suffered from CKD. This analysis illustrates for the first time on a nationwide basis the association of CKD with adverse outcomes in patients who underwent transcatheter aortic valve implantation. Thus, classification of CKD stages

Blood Pressure and Arterial Load After Transcatheter Aortic Valve Replacement for Aortic Stenosis.

PubMed

Lindman, Brian R; Otto, Catherine M; Douglas, Pamela S; Hahn, Rebecca T; Elmariah, Sammy; Weissman, Neil J; Stewart, William J; Ayele, Girma M; Zhang, Feifan; Zajarias, Alan; Maniar, Hersh S; Jilaihawi, Hasan; Blackstone, Eugene; Chinnakondepalli, Khaja M; Tuzcu, E Murat; Leon, Martin B; Pibarot, Philippe

2017-07-01

After aortic valve replacement, left ventricular afterload is often characterized by the residual valve obstruction. Our objective was to determine whether higher systemic arterial afterload-as reflected in blood pressure, pulsatile and resistive load-is associated with adverse clinical outcomes after transcatheter aortic valve replacement (TAVR). Total, pulsatile, and resistive arterial load were measured in 2141 patients with severe aortic stenosis treated with TAVR in the PARTNER I trial (Placement of Aortic Transcatheter Valve) who had systolic blood pressure (SBP) and an echocardiogram obtained 30 days after TAVR. The primary end point was 30-day to 1-year all-cause mortality. Lower SBP at 30 days after TAVR was associated with higher mortality (20.0% for SBP 100-129 mm Hg versus 12.0% for SBP 130-170 mm Hg; P <0.001). This association remained significant after adjustment, was consistent across subgroups, and confirmed in sensitivity analyses. In adjusted models that included SBP, higher total and pulsatile arterial load were associated with increased mortality ( P <0.001 for all), but resistive load was not. Patients with low 30-day SBP and high pulsatile load had a 3-fold higher mortality than those with high 30-day SBP and low pulsatile load (26.1% versus 8.1%; hazard ratio, 3.62; 95% confidence interval, 2.36-5.55). Even after relief of valve obstruction in patients with aortic stenosis, there is an independent association between post-TAVR blood pressure, systemic arterial load, and mortality. Blood pressure goals in patients with a history of aortic stenosis may need to be redefined. Increased pulsatile arterial load, rather than blood pressure, may be a target for adjunctive medical therapy to improve outcomes after TAVR. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894. © 2017 American Heart Association, Inc.

[Transcatheter aortic valve replacement].

PubMed

Sawa, Yoshiki

2014-07-01

While transcatheter aortic valve replacement( TAVR) has spread rapidly all over the world for highrisk patients with severe aortic stenosis (AS), SAPIEN XT was approved in Japan in October 2013. Since that, approximately 400 TAVR cases were performed in Japan. In our institute, we have performed 164 cases since first case in Japan in 2009 and have achieved satisfactory early results(30-day mortality:1.2%). At the same time, however, simultaneously various TAVR-related complications including a paravalvular leak, stroke, vascular complications, and coronary obstruction were observed. A reduction in the incidence and severity of these complications had led technical improvements in various new devices(2nd generation TAVR device such as the SAPIEN 3, ACURATE, and JenaValve) and in implantation techniques including repositioning/recapturing features, paravalvular sealing technologies, and prevention of coronary obstruction. Furthermore, there is also increasing experience with special indications for TAVR such as pure aortic valve insufficiency or valve-in-valve techniques. Currently, an increasing number of publications of midterm results demonstrate good prosthetic valve function and durability, with good quality of life and low morbidity after TAVR. There are also some randomized trials such as PARTNER 2 or SURTAVI to investigate potential benefits of TAVR for intermediate-risk patients. These improvements in the TAVR devices promises the expansion of TAVR towards the treatment of lower-risk patients in the near future.

[Transcatheter aortic valve implantation for aortic stenosis. Initial experience].

PubMed

Careaga-Reyna, Guillermo; Lázaro-Castillo, José Luis; Lezama-Urtecho, Carlos Alberto; Macías-Miranda, Enriqueta; Dosta-Herrera, Juan José; Galván Díaz, José

Aortic stenosis is a frequent disease in the elderly, and is associated with other systemic pathologies that may contraindicate the surgical procedure. Another option for these patients is percutaneous aortic valve implantation, which is less invasive. We present our initial experience with this procedure. Patients with aortic stenosis were included once selection criteria were accomplished. Under general anaesthesia and echocardiographic and fluosocopic control, a transcatheter aortic valve was implanted following s valvuloplasty. Once concluded the procedure, angiographic and pressure control was realized in order to confirm the valve function. Between November 2014 and May 2015, 6 patients were treated (4 males and 2 females), with a mean age of 78.83±5.66 years-old. The preoperative transvalvular gradient was 90.16±28.53mmHg and posterior to valve implant was 3.33±2.92mmHg (P<.05). Two patients had concomitant coronary artery disease which had been treated previously. One patient presented with acute right coronary artery occlusion which was immediately treated. However due to previous renal failure, postoperative sepsis and respiratory failure, the patient died one month later. It was concluded that our preliminary results showed that in selected patients percutaneous aortic valve implantation is a safe procedure with clinical improvement for treated patients. Copyright © 2016 Academia Mexicana de Cirugía A.C. Publicado por Masson Doyma México S.A. All rights reserved.

A multicentre European registry to evaluate the Direct Flow Medical transcatheter aortic valve system for the treatment of patients with severe aortic stenosis.

PubMed

Naber, Christoph K; Pyxaras, Stylianos A; Ince, Hüseyin; Frambach, Peter; Colombo, Antonio; Butter, Christian; Gatto, Fernando; Hink, Ulrich; Nickenig, Georg; Bruschi, Giuseppe; Brueren, Guus; Tchétché, Didier; Den Heijer, Peter; Schillinger, Wolfgang; Scholtz, Smita; Van der Heyden, Jan; Lefèvre, Thierry; Gilard, Martine; Kuck, Karl-Heinz; Schofer, Joachim; Divchev, Dimitar; Baumgartner, Helmut; Asch, Federico; Wagner, Daniel; Latib, Azeem; De Marco, Federico; Kische, Stephan

2016-12-10

Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System (DFM-TAVS), when used in routine clinical practice. This is a prospective, open-label, multicentre, post-market registry of patients treated with DFM-TAVS according to approved commercial indications. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee. The primary endpoint was freedom from all-cause mortality at 30 days post procedure. Secondary endpoints included procedural, early safety and efficacy endpoints at 30 days. Two hundred and fifty patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) with the DFM-TAVS were enrolled in 21 European centres. The primary endpoint, freedom from all-cause mortality at 30 days, was met in 98% (245/250) of patients. Device success was 83.8%. Moderate or severe aortic regurgitation was reported in 3% of patients, and none/trace regurgitation in 73% of patients. Post-procedural permanent pacemaker implantation was performed in 30 patients (12.0%). The DFM-TAVS was associated with good short-term outcomes in this real-world registry. The low pacemaker and aortic regurgitation rates confirm the advantages of this next-generation transcatheter heart valve (THV).

Updated clinical indications for transcatheter aortic valve implantation in patients with severe aortic stenosis: expert opinion of the Italian Society of Cardiology and GISE.

PubMed

Indolfi, Ciro; Bartorelli, Antonio L; Berti, Sergio; Golino, Paolo; Esposito, Giovanni; Musumeci, Giuseppe; Petronio, Sonia; Tamburino, Corrado; Tarantini, Giuseppe; Ussia, Gianpaolo; Vassanelli, Corrado; Spaccarotella, Carmen; Violini, Roberto; Mercuro, Giuseppe; Romeo, Francesco

2018-05-01

: The introduction of percutaneous treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) remains one of the greatest achievements of interventional cardiology. In fact, TAVI emerged as a better option than either medical therapy or balloon aortic valvuloplasty for patients who cannot undergo surgical aortic valve replacement (SAVR) or are at high surgical risk. Recently, increased operator experience and improved device systems have led to a worldwide trend toward the extension of TAVI to low-risk or intermediate-risk patients. In this expert opinion paper, we first discuss the basic pathophysiology of aortic stenosis in different settings then the key results of recent clinical investigations on TAVI in intermediate-risk aortic stenosis patients are summarized. Particular emphasis is placed on the results of the nordic aortic valve intervention, placement of aortic transcatheter valves (PARTNER) 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Randomized trials. The PARTNER 2 was the first large randomized trial that evaluated the outcome of TAVI in patients at intermediate risk. The PARTNER 2 data demonstrated that TAVI is a feasible and reasonable alternative to surgery in intermediate-risk patients (Society of Thoracic Surgeons 4-8%), especially if they are elderly or frail. There was a significant interaction between TAVI approach and mortality, with transfemoral TAVI showing superiority over SAVR. Moreover, we examine the complementary results of the recently concluded Surgical Replacement and Transcatheter Aortic Valve Implantation trial. This prospective randomized trial demonstrated that TAVI is comparable with surgery (primary end point 12.6% in the TAVI group vs. 14.0% in the SAVR group) in severe aortic stenosis patients deemed to be at intermediate risk. We review the most relevant clinical evidence deriving from nonrandomized studies and meta-analyses. Altogether, clinical outcome available data

Transcatheter Aortic Valve Implantation in an Extremely Tortuous S-Shaped Aorta

PubMed Central

Toleva, Olga; Pozeg, Zlatko; Menkis, Alan

2017-01-01

Transcatheter aortic valve implantation (TAVI) has emerged as an alternative technique to treating aortic stenosis in patients with high surgical risk. We present a case of a successful transfemoral TAVI in a high-risk patient with an extremely tortuous iliofemoral system and a significant S-type bend in the descending aorta. With careful preprocedure planning and using all the techniques available, TAVI can be performed in the most challenging patients. PMID:28352480

Patient-specific simulation of guidewire deformation during transcatheter aortic valve implantation.

PubMed

Vy, Phuoc; Auffret, Vincent; Castro, Miguel; Badel, Pierre; Rochette, Michel; Haigron, Pascal; Avril, Stéphane

2018-06-01

Transcatheter aortic valve implantation is a recent mini-invasive procedure to implant an aortic valve prosthesis. Prosthesis positioning in transcatheter aortic valve implantation appears as an important aspect for the success of the intervention. Accordingly, we developed a patient-specific finite element framework to predict the insertion of the stiff guidewire, used to position the aortic valve. We simulated the guidewire insertion for 2 patients based on their pre-operative CT scans. The model was designed to primarily predict the position and the angle of the guidewires in the aortic valve, and the results were successfully compared with intraoperative images. The present paper describes extensively the numerical model, which was solved by using the ANSYS software with an implicit resolution scheme, as well as the stabilization techniques which were used to overcome numerical instabilities. We performed sensitivity analysis on the properties of the guidewire (curvature angle, curvature radius, and stiffness) and the conditions of insertion (insertion force and orientation). We also explored the influence of the model parameters. The accuracy of the model was quantitatively evaluated as the distance and the angle difference between the simulated guidewires and the intraoperative ones. A good agreement was obtained between the model predictions and intraoperative views available for 2 patient cases. In conclusion, we showed that the shape of the guidewire in the aortic valve was mainly determined by the geometry of the patient's aorta and by the conditions of insertion (insertion force and orientation). Copyright © 2018 John Wiley & Sons, Ltd.

Registry of transcatheter aortic-valve implantation in high-risk patients.

PubMed

Gilard, Martine; Eltchaninoff, Hélène; Iung, Bernard; Donzeau-Gouge, Patrick; Chevreul, Karine; Fajadet, Jean; Leprince, Pascal; Leguerrier, Alain; Lievre, Michel; Prat, Alain; Teiger, Emmanuel; Lefevre, Thierry; Himbert, Dominique; Tchetche, Didier; Carrié, Didier; Albat, Bernard; Cribier, Alain; Rioufol, Gilles; Sudre, Arnaud; Blanchard, Didier; Collet, Frederic; Dos Santos, Pierre; Meneveau, Nicolas; Tirouvanziam, Ashok; Caussin, Christophe; Guyon, Philippe; Boschat, Jacques; Le Breton, Herve; Collart, Frederic; Houel, Remi; Delpine, Stephane; Souteyrand, Geraud; Favereau, Xavier; Ohlmann, Patrick; Doisy, Vincent; Grollier, Gilles; Gommeaux, Antoine; Claudel, Jean-Philippe; Bourlon, Francois; Bertrand, Bernard; Van Belle, Eric; Laskar, Marc

2012-05-03

Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2. All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause. A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival. This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).

Unusual cause of central aortic prosthetic regurgitation during transcatheter replacement.

PubMed

López-Mínguez, José Ramón; Millán-Núñez, Victoria; González-Fernández, Reyes; Nogales-Asensio, Juan Manuel; Fuentes-Cañamero, María Eugenia; Merchán-Herrera, Antonio

2016-04-01

Transcatheter aortic valve replacement (TAVR) is an increasingly common procedure for the treatment of aortic stenosis in elderly patients with comorbidities that prevent the use of standard surgery. It has been shown that implantation without aortic regurgitation is related to lower mortality. Mild paravalvular regurgitation is inevitable in some cases due to calcification of the aortic annulus and its usually somewhat elliptical shape. Central regurgitation is less common, but has been associated with valve overdilatation in cases in which reduction of paravalvular regurgitation was attempted after the initial inflation. However, there are no reported cases of central prosthetic aortic regurgitation due to acute LV dysfunction. We report a case in which central aortic regurgitation occurred due to transient ventricular dysfunction secondary to occlusion of the right coronary artery by an embolus. The regurgitation disappeared after thrombus aspiration and normal ventricular function was immediately recovered. Copyright © 2016 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Computer Vision Techniques for Transcatheter Intervention

PubMed Central

Zhao, Feng; Roach, Matthew

2015-01-01

Minimally invasive transcatheter technologies have demonstrated substantial promise for the diagnosis and the treatment of cardiovascular diseases. For example, transcatheter aortic valve implantation is an alternative to aortic valve replacement for the treatment of severe aortic stenosis, and transcatheter atrial fibrillation ablation is widely used for the treatment and the cure of atrial fibrillation. In addition, catheter-based intravascular ultrasound and optical coherence tomography imaging of coronary arteries provides important information about the coronary lumen, wall, and plaque characteristics. Qualitative and quantitative analysis of these cross-sectional image data will be beneficial to the evaluation and the treatment of coronary artery diseases such as atherosclerosis. In all the phases (preoperative, intraoperative, and postoperative) during the transcatheter intervention procedure, computer vision techniques (e.g., image segmentation and motion tracking) have been largely applied in the field to accomplish tasks like annulus measurement, valve selection, catheter placement control, and vessel centerline extraction. This provides beneficial guidance for the clinicians in surgical planning, disease diagnosis, and treatment assessment. In this paper, we present a systematical review on these state-of-the-art methods. We aim to give a comprehensive overview for researchers in the area of computer vision on the subject of transcatheter intervention. Research in medical computing is multi-disciplinary due to its nature, and hence, it is important to understand the application domain, clinical background, and imaging modality, so that methods and quantitative measurements derived from analyzing the imaging data are appropriate and meaningful. We thus provide an overview on the background information of the transcatheter intervention procedures, as well as a review of the computer vision techniques and methodologies applied in this area. PMID:27170893

High-risk Trans-Catheter Aortic Valve Replacement in a Failed Freestyle Valve with Low Coronary Height: A Case Report.

PubMed

Karimi, Ashkan; Pourafshar, Negiin; Dibu, George; Beaver, Thomas M; Bavry, Anthony A

2017-06-01

A 55-year-old male with a history of two prior cardiac surgeries presented with decompensated heart failure due to severe bioprosthetic aortic valve insufficiency. A third operation was viewed prohibitively high risk and valve-in-valve trans-catheter aortic valve replacement was considered. There were however several high-risk features and technically challenging aspects including low coronary ostia height, poor visualization of the aortic sinuses, and difficulty in identification of the coplanar view due to severe aortic insufficiency, and a highly mobile aortic valve mass. After meticulous peri-procedural planning, trans-catheter aortic valve replacement was carried out with a SAPIEN 3 balloon-expandable valve without any complication. Strategies undertaken to navigate the technically challenging aspects of the case are discussed.

An augmented magnetic navigation system for Transcatheter Aortic Valve Implantation.

PubMed

Luo, Zhe; Cai, Junfeng; Nie, Yuanyuan; Wang, Guotai; Gu, Lixu

2013-01-01

This research proposes an augmented magnetic navigation system for Transcatheter Aortic Valve Implantation (TAVI) employing a magnetic tracking system (MTS) combined with a dynamic aortic model and intra-operative ultrasound (US) images. The dynamic 3D aortic model is constructed based on the preoperative 4D computed tomography (CT), which is animated according to the real time electrocardiograph (ECG) input of patient. And a preoperative planning is performed to determine the target position of the aortic valve prosthesis. The temporal alignment is performed to synchronize the ECG signals, intra-operative US image and tracking information. Afterwards, with the assistance of synchronized ECG signals, the contour of aortic root automatic extracted from short axis US image is registered to the dynamic aortic model by a feature based registration intra-operatively. Then the augmented MTS guides the interventionist to confidently position and deploy the aortic valve prosthesis to target. The system was validated by animal studies on three porcine subjects, the deployment and tilting errors of which are 3.17 ± 0.91 mm and 7.40 ± 2.89° respectively.

Transcatheter Aortic Valve Replacement: a Kidney’s Perspective

PubMed Central

Cheungpasitporn, Wisit; Thongprayoon, Charat; Kashani, Kianoush

2016-01-01

Transcatheter aortic valve replacement (TAVR) has now emerged as a viable treatment option for high-risk patients with severe aortic stenosis (AS) who are not suitable candidates for surgical aortic valve replacement (SAVR). Despite encouraging published outcomes, acute kidney injury (AKI) is common and lowers the survival of patients after TAVR. The pathogenesis of AKI after TAVR is multifactorial including TAVR specific factors such as the use of contrast agents, hypotension during rapid pacing, and embolization; preventive measures may include pre-procedural hydration, limitation of contrast dye exposure, and avoidance of intraprocedural hypotension. In recent years, the number of TAVR performed worldwide has been increasing, as well as published data on renal perspectives of TAVR including AKI, chronic kidney disease, end-stage kidney disease, and kidney transplantation. This review aims to present the current literature on the nephrology aspects of TAVR, ultimately to improve the patients’ quality of care and outcomes. PMID:27069960

Elevation of B-Type Natriuretic Peptide at Discharge is Associated With 2-Year Mortality After Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis: Insights From a Multicenter Prospective OCEAN-TAVI (Optimized Transcatheter Valvular Intervention-Transcatheter Aortic Valve Implantation) Registry.

PubMed

Mizutani, Kazuki; Hara, Masahiko; Iwata, Shinichi; Murakami, Takashi; Shibata, Toshihiko; Yoshiyama, Minoru; Naganuma, Toru; Yamanaka, Futoshi; Higashimori, Akihiro; Tada, Norio; Takagi, Kensuke; Araki, Motoharu; Ueno, Hiroshi; Tabata, Minoru; Shirai, Shinichi; Watanabe, Yusuke; Yamamoto, Masanori; Hayashida, Kentaro

2017-07-14

In this study, we sought to investigate the 2-year prognostic impact of B-type natriuretic peptide (BNP) levels at discharge, following transcatheter aortic valve replacement. We enrolled 1094 consecutive patients who underwent transcatheter aortic valve replacement between 2013 and 2016. Study patients were stratified into 2 groups according to survival classification and regression tree analysis (high versus low BNP groups). We evaluated the impact of high BNP on 2-year mortality compared with that of low BNP using a multivariable Cox model, and assessed whether this stratification would improve predictive accuracy for determining 2-year mortality by assessing time-dependent net reclassification improvement and integrated discrimination improvement. The median age of patients was 85 years (quartile 82-88), and 29.2% of the study population were men. The median Society of Thoracic Surgeons score was 6.8 (4.7-9.5), and BNP at discharge was 186 (93-378) pg/mL. All-cause mortality following discharge was 7.9% (95% CI, 5.8-9.9%) at 1 year and 15.4% (95% CI, 11.6-19.0%) at 2 years. The survival classification and regression tree analysis revealed that the discriminating BNP level to discern 2-year mortality was 202 pg/mL, and that elevated BNP had a statistically significant impact on outcomes, with an adjusted hazard ratio of 2.28 (1.36-3.82, P =0.002). The time-dependent net reclassification improvement ( P =0.047) and integrated discrimination improvement ( P =0.029) analysis revealed that the incorporation of BNP stratification with other clinical variables significantly improved predictive accuracy for 2-year mortality. Elevation of BNP at discharge is associated with 2-year mortality after transcatheter aortic valve replacement. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Early outcomes of transcatheter aortic valve replacement in patients with severe aortic stenosis: single center experience

PubMed Central

Bozkurt, Engin; Keleş, Telat; Durmaz, Tahir; Akçay, Murat; Ayhan, Hüseyin; Bayram, Nihal Akar; Aslan, Abdullah Nabi; Baştuğ, Serdal; Bilen, Emine

2014-01-01

Introduction Transcatheter aortic valve implantation is a promising alternative to high risk surgical aortic valve replacement. The procedure is mainly indicated in patients with severe symptomatic aortic stenosis who cannot undergo surgery or who are at very high surgical risk. Aim Description early results of our single-center experience with balloon expandable aortic valve implantation. Material and methods Between July 2011 and August 2012, we screened in total 75 consecutive patients with severe aortic stenosis and high risk for surgery. Twenty-one of them were found ineligible for transcatheter aortic valve implantation (TAVI) because of various reasons, and finally we treated a total of 54 patients with symptomatic severe aortic stenosis (AS) who could not be treated by open heart surgery (inoperable) because of high-risk criteria. The average age of the patients was 77.4 ±7.1; 27.8% were male and 72.2% were female. The number of patients in NYHA class II was 7 while the number of patients in class III and class IV was 47. Results The average mortality score of patients according to the STS scoring system was 8.5%. Pre-implantation mean and maximal aortic valve gradients were measured as 53.2 ±14.1 mm Hg and 85.5 ±18.9 mm Hg, respectively. Post-implantation mean and maximal aortic valve gradients were 9.0 ±3.0 and 18.2 ±5.6, respectively (p < 0.0001). The left ventricular ejection fraction was calculated as 54.7 ±14.4% before the operation and 58.0 ±11.1% after the operation (p < 0.0001). The duration of discharge after the operation was 5.29 days, and a statistically significant correlation between the duration of discharge after the operation and STS was found (r = 0385, p = 0.004). Conclusions We consider that with decreasing cost and increasing treatment experience, TAVI will be used more frequently in broader indications. Our experience with TAVI using the Edwards-Sapien XT (Edwards Lifesciences, Irvine, CA) devices suggests that this is an

Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation.

PubMed

Seiffert, Moritz; Bader, Ralf; Kappert, Utz; Rastan, Ardawan; Krapf, Stephan; Bleiziffer, Sabine; Hofmann, Steffen; Arnold, Martin; Kallenbach, Klaus; Conradi, Lenard; Schlingloff, Friederike; Wilbring, Manuel; Schäfer, Ulrich; Diemert, Patrick; Treede, Hendrik

2014-10-01

This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation. Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus. Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed. Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI. Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Concomitant Transapical Transcatheter Valve Implantations: Edwards Sapien Valve for Severe Mitral Regurgitation in a Patient with Failing Mitral Bioprostheses and JenaValve for the Treatment of Pure Aortic Regurgitation.

PubMed

Aydin, Unal; Gul, Mehmet; Aslan, Serkan; Akkaya, Emre; Yildirim, Aydin

2015-04-28

Transcatheter valve implantation is a novel interventional technique, which was developed as an  alternative therapy for surgical aortic valve replacement in inoperable patients with severe aortic stenosis. Despite limited experience in using transcatheter valve implantation for mitral and aortic regurgitation, transapical transcatheter aortic valve implantation and valve-in-valve implantation for degenerated mitral valve bioprosthesis can be performed in high-risk patients who are not candidates for conventional replacement surgery. In this case, we present the simultaneous transcatheter valve implantation via transapical approach for both degenerated bioprosthetic mitral valve with severe regurgitation and pure severe aortic regurgitation.

Safety and efficacy of minimalist approach in transfemoral transcatheter aortic valve replacement: insights from the Optimized transCathEter vAlvular interventioN-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry.

PubMed

Hosoba, Soh; Yamamoto, Masanori; Shioda, Kayoko; Sago, Mitsuru; Koyama, Yutaka; Shimura, Tetsuro; Kagase, Ai; Tada, Norio; Naganuma, Toru; Araki, Motoharu; Yamanaka, Futoshi; Shirai, Shinichi; Watanabe, Yusuke; Hayashida, Kentaro

2018-03-01

Favourable results have been reported for monitored anaesthesia care that includes local anaesthesia and conscious sedation [minimalist approach (MA)] for transfemoral transcatheter aortic valve replacement (TAVR). However, the efficacy of MA is still controversial in Japan. We describe our experience from a Japanese multicentre registry. Between October 2013 and April 2016, 1215 consecutive Japanese patients with symptomatic, severe aortic stenosis undergoing TAVR with self-expandable or balloon-expandable valves were prospectively included in the Optimized transCathEter vAlvular intervention-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry. Of these patients, we retrospectively reviewed 921 consecutive patients who underwent elective transfemoral-TAVR. We evaluated the perioperative results of MA-TAVR and non-minimalist approach (NMA) TAVR using propensity score matching analysis. A total of 118 patients underwent MA-TAVR, and 802 patients underwent NMA-TAVR [median age 84 vs 85 years, P = 0.25; Society of Thoracic Surgeons (STS) score 7.6 vs 6.4, P = 0.01]. One hundred eighteen matched pairs were compared after propensity score matching. In-hospital mortality and stroke/transient ischaemic attack were not significantly different between the MA-TAVR and the NMA-TAVR groups (2.5% vs 0.8%, P = 0.3; 1.7% vs 0.8%, P = 0.6, respectively). Major or life-threatening bleeding and the transfusion rate were significantly lower in the MA-TAVR group (3.4% vs 17%, P = 0.003; 6.8% vs 29%, P = 0.0002, respectively). The total intensive care unit days and length of hospital stay were significantly lower in the MA-TAVR group (P ≤ 0.0002). MA-TAVR has similar results to NMA-TAVR in terms of mortality and stroke in this Japanese multicentre registry. Shorter procedure time and hospital stays were seen in the MA-TAVR group. MA-TAVR is as safe and effective as NMA-TAVR. © The Author 2017. Published by Oxford University Press on behalf of

Pros and cons of transcatheter aortic valve implantation (TAVI).

PubMed

Terré, Juan A; George, Isaac; Smith, Craig R

2017-09-01

Transcatheter aortic valve implantation (TAVI) or replacement (TAVR) was recently approved by the FDA for intermediate risk patients with severe aortic stenosis (AS). This technique was already worldwide adopted for inoperable and high-risk patients. Improved device technology, imaging analysis and operator expertise has reduced the initial worrisome higher complications rate associated with TAVR, making it comparable to surgical aortic valve replacement (SAVR). However, many answers need to be addressed before adoption in lower risk patients. This paper highlights the pros and cons of TAVI based mostly on randomized clinical trials involving the two device platforms approved in the United States. We focused our analysis on metrics that will play a key role in expanding TAVR indication in healthier individuals. We review the significance and gave a perspective on paravalvular leak (PVL), valve performance, valve durability, leaflet thrombosis, stroke and pacemaker requirement.

Costs of periprocedural complications in patients treated with transcatheter aortic valve replacement: results from the Placement of Aortic Transcatheter Valve trial.

PubMed

Arnold, Suzanne V; Lei, Yang; Reynolds, Matthew R; Magnuson, Elizabeth A; Suri, Rakesh M; Tuzcu, E Murat; Petersen, John L; Douglas, Pamela S; Svensson, Lars G; Gada, Hemal; Thourani, Vinod H; Kodali, Susheel K; Mack, Michael J; Leon, Martin B; Cohen, David J

2014-12-01

In patients with severe aortic stenosis, transcatheter aortic valve replacement (TAVR) improves survival when compared with nonsurgical therapy but with higher in-hospital and lifetime costs. Complications associated with TAVR may decrease with greater experience and improved devices, thereby reducing the overall cost of the procedure. Therefore, we sought to estimate the effect of periprocedural complications on in-hospital costs and length of stay of TAVR. Using detailed cost data from 406 TAVR patients enrolled in the Placement of Aortic Transcatheter Valve (PARTNER) I trial, we developed multivariable models to estimate the incremental cost and length of stay associated with specific periprocedural complications. Attributable costs and length of stay for each complication were calculated by multiplying the independent cost of each event by its frequency in the treatment group. Mean cost for the initial hospitalization was $79 619±40 570 ($50 891 excluding the valve); 49% of patients had ≥1 complication. Seven complications were independently associated with increased hospital costs, with major bleeding, arrhythmia, and death accounting for the largest attributable cost per patient. Renal failure and the need for repeat TAVR, although less frequent, were also associated with substantial incremental and attributable costs. Overall, complications accounted for $12 475 per patient in initial hospital costs and 2.4 days of hospitalization. In the PARTNER trial, periprocedural complications were frequent, costly, and accounted for ≈25% of non-implant-related hospital costs. Avoidance of complications should improve the cost-effectiveness of TAVR for inoperable and high-risk patients, but reductions in the cost of uncomplicated TAVR will also be necessary for optimal efficiency. http://www.clinicaltrials.gov. Unique identifier: NCT00530894. © 2014 American Heart Association, Inc.

Multicomponent cardiac rehabilitation in patients after transcatheter aortic valve implantation: Predictors of functional and psychocognitive recovery.

PubMed

Eichler, Sarah; Salzwedel, Annett; Reibis, Rona; Nothroff, Jörg; Harnath, Axel; Schikora, Martin; Butter, Christian; Wegscheider, Karl; Völler, Heinz

2017-02-01

Background In the last decade, transcatheter aortic valve implantation has become a promising treatment modality for patients with aortic stenosis and a high surgical risk. Little is known about influencing factors of function and quality of life during multicomponent cardiac rehabilitation. Methods From October 2013 to July 2015, patients with elective transcatheter aortic valve implantation and a subsequent inpatient cardiac rehabilitation were enrolled in the prospective cohort multicentre study. Frailty-Index (including cognition, nutrition, autonomy and mobility), Short Form-12 (SF-12), six-minute walk distance (6MWD) and maximum work load in bicycle ergometry were performed at admission and discharge of cardiac rehabilitation. The relation between patient characteristics and improvements in 6MWD, maximum work load or SF-12 scales were studied univariately and multivariately using regression models. Results One hundred and thirty-six patients (80.6 ± 5.0 years, 47.8% male) were enrolled. 6MWD and maximum work load increased by 56.3 ± 65.3 m ( p < 0.001) and 8.0 ± 14.9 watts ( p < 0.001), respectively. An improvement in SF-12 (physical 2.5 ± 8.7, p = 0.001, mental 3.4 ± 10.2, p = 0.003) could be observed. In multivariate analysis, age and higher education were significantly associated with a reduced 6MWD, whereas cognition and obesity showed a positive predictive value. Higher cognition, nutrition and autonomy positively influenced the physical scale of SF-12. Additionally, the baseline values of SF-12 had an inverse impact on the change during cardiac rehabilitation. Conclusions Cardiac rehabilitation can improve functional capacity as well as quality of life and reduce frailty in patients after transcatheter aortic valve implantation. An individually tailored therapy with special consideration of cognition and nutrition is needed to maintain autonomy and empower octogenarians in coping with challenges of everyday

Impact of Mitral Regurgitation on Clinical Outcomes After Transcatheter Aortic Valve Implantation

PubMed Central

Tüller, David; Zbinden, Rainer; Eberli, Franz R

2016-01-01

Severe aortic stenosis (AS) and mitral regurgitation (MR) are the two most common valvular lesions referred for surgical intervention in Europe and frequently co-exist. In patients with both severe AS and significant MR referred for surgical aortic valve replacement (SAVR), a concomitant mitral valve intervention is typically performed if the MR is severe, despite the higher associated perioperative risk. The management of moderate MR among SAVR patients is controversial and depends on a number of factors including MR aetiology (i.e., organic versus functional MR), feasibility of repair and patient risk profile. Moderate or severe MR is present in up to one-third of patients undergoing transcatheter aortic valve implantation (TAVI), is mainly of functional aetiology and is typically left untreated. Although data are conflicting, a growing body of evidence suggests that significant MR exerts an adverse effect on both short- and long-term clinical outcomes after TAVI. Moderate or severe MR improves in just over half of patients following TAVI and recent data suggest MR is more likely to improve among patients receiving a balloon-expandable as compared with a self-expandable transcatheter heart valve. PMID:29588707

Pros and cons of transcatheter aortic valve implantation (TAVI)

PubMed Central

Terré, Juan A.; George, Isaac

2017-01-01

Transcatheter aortic valve implantation (TAVI) or replacement (TAVR) was recently approved by the FDA for intermediate risk patients with severe aortic stenosis (AS). This technique was already worldwide adopted for inoperable and high-risk patients. Improved device technology, imaging analysis and operator expertise has reduced the initial worrisome higher complications rate associated with TAVR, making it comparable to surgical aortic valve replacement (SAVR). However, many answers need to be addressed before adoption in lower risk patients. This paper highlights the pros and cons of TAVI based mostly on randomized clinical trials involving the two device platforms approved in the United States. We focused our analysis on metrics that will play a key role in expanding TAVR indication in healthier individuals. We review the significance and gave a perspective on paravalvular leak (PVL), valve performance, valve durability, leaflet thrombosis, stroke and pacemaker requirement. PMID:29062739

Assessment of structural valve deterioration of transcatheter aortic bioprosthetic balloon-expandable valves using the new European consensus definition.

PubMed

Eltchaninoff, Hélène; Durand, Eric; Avinée, Guillaume; Tron, Christophe; Litzler, Pierre-Yves; Bauer, Fabrice; Dacher, Jean-Nicolas; Werhlin, Camille; Bouhzam, Najime; Bettinger, Nicolas; Candolfi, Pascal; Cribier, Alain

2018-03-30

Durability of transcatheter aortic bioprosthetic valves remains a major issue. Standardised definitions of deterioration and failure of bioprosthetic valves have recently been proposed. The aim of this study was to assess structural transcatheter valve deterioration (SVD) and bioprosthetic valve failure (BVF) using these new definitions. All TAVI patients implanted up to September 2012 with a minimal theoretical five-year follow-up were included. Systematic clinical and echocardiographic follow-up was performed annually. New standardised definitions were used to assess durability of transcatheter aortic bioprosthetic valves. From 2002 to 2012, 378 patients were included. Mean age and logistic EuroSCORE were 83.3±6.8 years and 22.8±13.1%. Thirty-day mortality was 13.2%. Nine patients had SVD including two severe forms and two patients had definite late BVF. The incidence of SVD and BVF at eight years was 3.2% (95% CI: 1.45-6.11) and 0.58% (95% CI: 0.15-2.75), respectively. Even though limited by the poor survival of the very high-risk/compassionate early population, our data do not demonstrate any alarm concerning transcatheter aortic valve durability. Careful prospective assessment in younger and lower-risk patients and comparison with surgical bioprosthetic valves are required for further assessment of the long-term durability of transcatheter valves.

Calcification Characteristics of Low-Flow Low-Gradient Severe Aortic Stenosis in Patients Undergoing Transcatheter Aortic Valve Replacement

PubMed Central

Stähli, Barbara E.; Nguyen-Kim, Thi Dan Linh; Gebhard, Cathérine; Frauenfelder, Thomas; Tanner, Felix C.; Nietlispach, Fabian; Maisano, Francesco; Falk, Volkmar; Lüscher, Thomas F.; Maier, Willibald; Binder, Ronald K.

2015-01-01

Low-flow low-gradient severe aortic stenosis (LFLGAS) is associated with worse outcomes. Aortic valve calcification patterns of LFLGAS as compared to non-LFLGAS have not yet been thoroughly assessed. 137 patients undergoing transcatheter aortic valve replacement (TAVR) with preprocedural multidetector computed tomography (MDCT) and postprocedural transthoracic echocardiography were enrolled. Calcification characteristics were assessed by MDCT both for the total aortic valve and separately for each leaflet. 34 patients had LFLGAS and 103 non-LFLGAS. Total aortic valve calcification volume (p < 0.001), mass (p < 0.001), and density (p = 0.004) were lower in LFLGAS as compared to non-LFLGAS patients. At 30-day follow-up, mean transaortic pressure gradients and more than mild paravalvular regurgitation did not differ between groups. In conclusion, LFLGAS and non-LFLGAS express different calcification patterns which, however, did not impact on device success after TAVR. PMID:26435875

Transcatheter aortic valve implantation for failing surgical aortic bioprosthetic valve: from concept to clinical application and evaluation (part 2).

PubMed

Piazza, Nicolo; Bleiziffer, Sabine; Brockmann, Gernot; Hendrick, Ruge; Deutsch, Marcus-André; Opitz, Anke; Mazzitelli, Domenico; Tassani-Prell, Peter; Schreiber, Christian; Lange, Rüdiger

2011-07-01

This study sought to review the acute procedural outcomes of patients who underwent transcatheter aortic valve (TAV)-in-surgical aortic valve (SAV) implantation at the German Heart Center, Munich, and to summarize the existing literature on TAV-in-SAV implantation (n = 47). There are several case reports and small case series describing transcatheter aortic valve implantation for a failing surgical aortic valve bioprosthesis (TAV-in-SAV implantation). From January 2007 to March 2011, 20 out of 556 patients underwent a TAV-in-SAV implantation at the German Heart Center Munich. Baseline characteristics and clinical outcome data were prospectively entered into a dedicated database. The mean patient age was 75 ± 13 years, and the mean logistic European System for Cardiac Operative Risk Evaluation and Society of Thoracic Surgeons' Risk Model scores were 27 ± 13% and 7 ± 4%, respectively. Of the 20 patients, 14 had stented and 6 had stentless surgical bioprostheses. Most cases (12 of 20) were performed via the transapical route using a 23-mm Edwards Sapien prosthesis (Edwards Lifesciences, Irvine, California). Successful implantation of a TAV in a SAV with the patient leaving the catheterization laboratory alive was achieved in 18 of 20 patients. The mean transaortic valve gradient was 20.0 ± 7.5 mm Hg. None-to-trivial, mild, and mild-to-moderate paravalvular aortic regurgitation was observed in 10, 6, and 2 patients, respectively. We experienced 1 intraprocedural death following pre-implant balloon aortic valvuloplasty ("stone heart") and 2 further in-hospital deaths due to myocardial infarction. TAV-in-SAV implantation is a safe and feasible treatment for high-risk patients with failing aortic bioprosthetic valves and should be considered as part of the armamentarium in the treatment of aortic bioprosthetic valve failure. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Latest evidence on transcatheter aortic valve implantation vs. surgical aortic valve replacement for the treatment of aortic stenosis in high and intermediate-risk patients.

PubMed

Praz, Fabien; Siontis, George C M; Verma, Subodh; Windecker, Stephan; Jüni, Peter

2017-03-01

The goal of this review is to summarize the current evidence supporting the use of transcatheter aortic valve implantation (TAVI) in high and intermediate-risk patients. The focus is on the five randomized controlled trials comparing TAVI with surgical aortic valve replacement (SAVR) published to date, as well as two recent meta-analyses. TAVI has profoundly transformed the treatment of elderly patients presenting with symptomatic severe aortic stenosis. In experienced hands, the procedure has become well tolerated and the results more predictable. So far, two trials using two different devices [Placement of Aortic Transcatheter Valve (PARTNER) 1A and US CoreValve High Risk] have shown that TAVI is able to compete in terms of mortality with SAVR in high-risk patients. These findings have been extended to the intermediate-risk population in two recently published randomized controlled trials [PARTNER 2 and Nordic Aortic Valve Intervention (NOTION)]. The two meta-analyses suggested improved survival in both high and intermediate-risk patients during the first 2 years following the intervention. The survival benefit was only found in patients treated via the transfemoral access, and appeared more pronounced in women. Individual randomized trials enrolling high and intermediate-risk patients have established the noninferiority of TAVI in comparison with SAVR, whereas subsequent meta-analyses suggest superiority of transfemoral TAVI in terms of a sustained survival benefit 2 years after valve implantation irrespective of the surgical risk category. The benefit of TAVI appears more pronounced in women than in men.

Outcomes of patients with chronic lung disease and severe aortic stenosis treated with transcatheter versus surgical aortic valve replacement or standard therapy: insights from the PARTNER trial (placement of AoRTic TraNscathetER Valve).

PubMed

Dvir, Danny; Waksman, Ron; Barbash, Israel M; Kodali, Susheel K; Svensson, Lars G; Tuzcu, E Murat; Xu, Ke; Minha, Sa'ar; Alu, Maria C; Szeto, Wilson Y; Thourani, Vinod H; Makkar, Raj; Kapadia, Samir; Satler, Lowell F; Webb, John G; Leon, Martin B; Pichard, Augusto D

2014-01-28

The study aimed to evaluate the impact of chronic lung disease (CLD) on outcomes of severe aortic stenosis patients across all treatment modalities. Outcomes of patients with CLD undergoing transcatheter aortic valve replacement (TAVR) have not been systematically examined. All patients who underwent TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve) trial, including the continued access registry (n = 2,553; 1,108 with CLD), were evaluated according to CLD clinical severity. Additionally, outcomes of CLD patients included in the randomization arms of the PARTNER trial were compared: Cohort A patients (high-risk operable) treated by either TAVR (n = 149) or surgical aortic valve replacement (SAVR); (n = 138); and Cohort B patients (inoperable) treated by either TAVR (n = 72) or standard therapy only (n = 95). Among all TAVR-treated patients, at 1-year follow-up, patients with CLD had higher mortality than those without it (23.4% vs. 19.6%, p = 0.02). Baseline characteristics of CLD patients who underwent TAVR were similar to respective controls. In Cohort A, 2-year all-cause death rates were similar (TAVR 35.2% and SAVR 33.6%, p = 0.92), whereas in Cohort B, the death rate was lower after TAVR (52.0% vs. 69.6% after standard therapy only, p = 0.04). Independent predictors for mortality in CLD patients undergoing TAVR included poor mobility (6-min walk test <50 m; hazard ratio: 1.67, p = 0.0009) and oxygen-dependency (hazard ratio: 1.44, p = 0.02). Although CLD patients undergoing TAVR have worse outcomes than patients without CLD, TAVR is better in these patients than standard therapy and is similar to SAVR. Although patients with CLD undergoing TAVR had worse outcomes than patients without CLD, TAVR performed better in these patients than standard therapy and was similar to SAVR. However, CLD patients who were either poorly mobile or oxygen-dependent had poor outcomes. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT

The effects of contrast media volume on acute kidney injury after transcatheter aortic valve replacement: a systematic review and meta-analysis.

PubMed

Thongprayoon, Charat; Cheungpasitporn, Wisit; Podboy, Alexander J; Gillaspie, Erin A; Greason, Kevin L; Kashani, Kianoush B

2016-11-01

The goal of this systematic review was to assess the effects of contrast media volume on transcatheter aortic valve replacement-related acute kidney injury. A literature search was performed using Medline, EMbase, the Cochrane Database of Systematic Reviews, and clinicaltrials.gov from the inception of these databases through December 2015. Studies that reported relative risk, odds ratio, or hazard ratio comparing the risks of acute kidney injury following transcatheter aortic valve replacement in patients who received high contrast media volume were included. Pooled risk ratio (RR) and 95% confidence intervals (95% CI) were calculated using a random-effect, generic inverse variance method. Four cohort studies composed of 891 patients were included in the analyses to assess the risk of acute kidney injury after transcatheter aortic valve replacement in patients who received high contrast media volume. The pooled RR of acute kidney injury after transcatheter aortic valve replacement in patients who received a large volume of contrast media was 1.41 (95% CI, 0.87 to 2.28) compared with low contrast media volume. The meta-analysis was limited to studies using standard acute kidney injury definitions, and the pooled RR of acute kidney injury in patients who received high contrast media volume is 1.12 (95% CI, 0.78 to 1.62). Our meta-analysis shows no significant association between contrast media volume and risk of acute kidney injury after transcatheter aortic valve replacement. © 2016 Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.

Vascular complications of transcatheter aortic valve replacement: A concise literature review

PubMed Central

Chaudhry, Muhammad Ali; Sardar, Muhammad Rizwan

2017-01-01

Transcatheter aortic valve replacement (TAVR) is a relatively newer therapeutic modality which offers a promising alternative to surgical aortic valve replacement for patients with prohibitive, high and intermediate surgical risk. The increasing trend to pursue TAVR in these patients has also led to growing awareness of the associated potential vascular complications. The significant impact of these complications on eventual clinical outcome and mortality makes prompt recognition and timely management a critical factor in TAVR patients. We hereby present a concise review with emphasis on diverse vascular complications associated with TAVR and their effective management to improve overall clinical outcomes. PMID:28824787

Costs of transcatheter versus surgical aortic valve replacement in intermediate-risk patients.

PubMed

Osnabrugge, Ruben L J; Head, Stuart J; Genders, Tessa S S; Van Mieghem, Nicolas M; De Jaegere, Peter P T; van der Boon, Robert M A; Kerkvliet, J Marco; Kalesan, Bindu; Bogers, Ad J J C; Kappetein, A Pieter; Hunink, M G Myriam

2012-12-01

Transcatheter aortic valve replacement (TAVR) offers a new treatment option for patients with aortic stenosis, but costs may play a decisive role in decision making. Current studies are evaluating TAVR in an intermediate-risk population. We assessed the in-hospital and 1-year follow-up costs of patients undergoing TAVR and surgical aortic valve replacement (SAVR) at intermediate operative risk and identified important cost components. We prospectively collected clinical data on 141 patients undergoing TAVR and 405 undergoing SAVR. Propensity score matching yielded 42 matched pairs at intermediate risk. Costs were assessed using a detailed resource-use approach and compared using bootstrap methods. In-hospital costs were higher in TAVR patients than in SAVR patients (€40802 vs €33354, respectively; p=0.010). The total costs at 1 year were €46217 vs €35511, respectively (p=0.009). The TAVR was less costly with regard to blood products, operating room use, and length-of-stay. For intermediate-risk patients with severe aortic stenosis the costs at 1 year are higher for TAVR than for SAVR. The difference was mainly caused by the higher costs of the transcatheter valve and was not compensated by the lower costs for blood products and hospital stay in TAVR patients. Therefore, SAVR remains a clinically and economically attractive treatment option. Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Comparison of outcomes of patients with left ventricular ejection fractions ≤30% versus ≥30% having transcatheter aortic valve implantation (from the German Transcatheter Aortic Valve Interventions Registry).

PubMed

Schaefer, Ulrich; Zahn, Ralf; Abdel-Wahab, Mohamed; Gerckens, Ulrich; Linke, Axel; Schneider, Steffen; Eggebrecht, Holger; Sievert, Horst; Figulla, Hans Reiner; Senges, Jochen; Kuck, Karl Heinz

2015-03-01

Transcatheter aortic valve implantation (TAVI) is rapidly evolving in Germany. Especially severe reduced left ventricular ejection fraction (LVEF) is known as a prominent risk factor for adverse outcome in open heart surgery. Thus, the data of the prospective multicenter German Transcatheter Aortic Valve Interventions Registry were analyzed for outcomes in patients with severe depressed LVEF. Data of 1,432 patients were consecutively collected after transcatheter aortic valve implantation. Patients were divided into 2 groups (A: LVEF ≤30%, n = 169, age 79.9 ± 6.7 years, logES 34.2 ± 17.8%; B: LVEF >30%, n = 1,263, age 82.0 ± 6.1 years, logES 18.9 ± 12.0%), and procedural success rates, New York Heart Association classification, and quality of life were compared at 30 days and 1 year, respectively. Technical success was achieved in 95.9% (A) and 97.6% (B). Survival and the New York Heart Association classification at 30 days demonstrated an excellent outcome in both groups. There was a significant improvement according to the self-assessment in health condition (0 to 100 scale) with a much larger gain in group A (28 vs 19 patients, p <0.0001). Nevertheless, low cardiac output syndrome (12.3% vs 5.9%, p <0.01) and resuscitation (10.4% vs 5.6%, p <0.05) were more frequently seen in group A, contributing to a higher mortality at 30 days (14.3% vs 7.2%) and 1 year (33.7% vs 18.1%, p <0.001). In conclusion, this real-world registry demonstrated a comparably high success rate for patients with severe reduced LVEF and an early improvement in functional status as demonstrated by substantial benefit, despite a doubled postprocedural mortality. Copyright © 2015 Elsevier Inc. All rights reserved.

Catheter tracking via online learning for dynamic motion compensation in transcatheter aortic valve implantation.

PubMed

Wang, Peng; Zheng, Yefeng; John, Matthias; Comaniciu, Dorin

2012-01-01

Dynamic overlay of 3D models onto 2D X-ray images has important applications in image guided interventions. In this paper, we present a novel catheter tracking for motion compensation in the Transcatheter Aortic Valve Implantation (TAVI). To address such challenges as catheter shape and appearance changes, occlusions, and distractions from cluttered backgrounds, we present an adaptive linear discriminant learning method to build a measurement model online to distinguish catheters from background. An analytic solution is developed to effectively and efficiently update the discriminant model and to minimize the classification errors between the tracking object and backgrounds. The online learned discriminant model is further combined with an offline learned detector and robust template matching in a Bayesian tracking framework. Quantitative evaluations demonstrate the advantages of this method over current state-of-the-art tracking methods in tracking catheters for clinical applications.

New-generation devices for transcatheter aortic valve implantation.

PubMed

Gatto, Laura; Biondi-Zoccai, Giuseppe; Romagnoli, Enrico; Frati, Giacomo; Prati, Francesco; Giordano, Arturo

2018-04-20

Transcatheter aortic valve implantation (TAVI) has overcome the pioneering phase and thanks to accrued clinical evidence has become a mainstay alternative to surgical aortic valve replacement (SAVR) in patients at high risk for post-operative complications. Despite these successes, TAVI remains a junior technology facing momentous developments in techniques and devices. Indeed, several new-generation devices for TAVI have become available in the last few years, including Acurate, Allegra, Evolut, Lotus, JenaValve, Portico, and SAPIEN3. Despite the inevitable setbacks, such as the one represented by DirectFlow, these new devices appear associated with comparative benefits, especially for minimal invasiveness, rates of permanent pacemaker implantation, and risk of residual aortic regurgitation. Indeed, no single device appears clearly better than the others, and a tailored and individualized approach should be sought in using these prostheses, taking into account operator and institutional expertise, on top of patient features. Few comparative effectiveness studies are available to date to guide decision making, and thus careful scrutiny is needed even in everyday clinical practice, especially if seeking to expand the current indications of TAVI. Further guidance will however come from long-term follow-up of completed studies and from results of ongoing trials.

Transcatheter aortic valve implantation transapical: step by step.

PubMed

Walther, Thomas; Möllmann, Helge; van Linden, Arnaud; Kempfert, Jörg

2011-01-01

Transcatheter aortic valve implantation (T-AVI) has been introduced into clinical practice to treat high-risk elderly patients with aortic stenosis. T-AVI can be performed by using a retrograde transfemoral (TF), transsubclavian, transaortic, and/or antegrade transapical (TA) approach. For TA-AVI, CE mark approval was granted in 2008 for the Edwards SAPIEN (Edwards Lifesciences, Irvine, CA) prosthesis with the Ascendra delivery system and in 2010 for the second-generation Edwards SAPIEN XT prosthesis and the Ascendra II delivery system, with 23-mm and 26-mm valves. In 2011, CE mark approval has been granted for TA-AVI by using the SAPIEN XT 29-mm prosthesis. Several other devices from different companies (Jenavalve, Jena Valve Inc, Munich, Germany; Embracer, Medtronic Inc, Guilford, CT; Accurate, Symetis Inc, Geneva, Switzerland) have passed "first in man trials" successfully and are being evaluated within multicenter pivotal studies. In this article we will focus on specific aspects of the TA technique for AVI. Copyright © 2011 Elsevier Inc. All rights reserved.

Transcatheter aortic valve-in-valve implantation of a CoreValve in a JenaValve prosthesis: a case report.

PubMed

Lotfi, Shahram; Becker, Michael; Moza, Ajay; Autschbach, Rüdiger; Marx, Nikolaus; Schröder, Jörg

2017-09-10

Transcatheter aortic valve implantation has become an accepted treatment modality for inoperable or high-risk surgical patients with symptomatic severe aortic stenosis. We report the case of a 70-year-old white man who was treated for severe symptomatic aortic regurgitation using transcatheter aortic valve implantation from the apical approach. Because of recurrent cardiac decompensation 4 weeks after implantation he underwent the implantation of a left ventricular assist device system. A year later echocardiography showed a severe transvalvular central insufficiency. Our heart team decided to choose a valve-in-valve approach while reducing the flow rate of left ventricular assist device to minimum and pacing with a frequency of 140 beats/minute. There was an excellent result and our patient is doing well with no relevant insufficiency of the aortic valve at 12-month follow-up. This is the first report about a successful treatment of a stenotic JenaValve using a CoreValve Evolut R; the use of a CoreValve Evolut R prosthesis may be an optimal option for valve-in-valve procedures.

Stent and leaflet stresses in a 26-mm first-generation balloon-expandable transcatheter aortic valve.

PubMed

Xuan, Yue; Krishnan, Kapil; Ye, Jian; Dvir, Danny; Guccione, Julius M; Ge, Liang; Tseng, Elaine E

2017-05-01

Transcatheter aortic valve replacement is established therapy for high-risk and inoperable patients with severe aortic stenosis, but questions remain regarding long-term durability. Valve design influences durability. Increased leaflet stresses in surgical bioprostheses have been correlated with degeneration; however, transcatheter valve leaflet stresses are unknown. From 2007 to 2014, a majority of US patients received first-generation balloon-expandable transcatheter valves. Our goal was to determine stent and leaflet stresses in this valve design using finite element analyses. A 26-mm Sapien Transcatheter Heart Valve (Edwards Lifesciences, Inc, Irvine, Calif) underwent high-resolution microcomputed tomography scanning to develop precise 3-dimensional geometry of the leaflets, the stent, and the polyethylene terephthalate elements. The stent was modeled using 3-dimensional elements and the leaflets were modeled using shell elements. Stent material properties were based on stainless steel, whereas those for leaflets were obtained from surgical bioprostheses. Noncylindrical Sapien valve geometry was also simulated. Pressure loading to 80 mm Hg and 120 mm Hg was performed using ABAQUS finite element software (Dassault Systèmes, Waltham, Mass). At 80 mm Hg, maximum principal stresses on Sapien leaflets were 1.31 megaspascals (MPa). Peak leaflet stress was observed at commissural tips where leaflets connected to the stent. Maximum principal stresses for the stent were 188.91 MPa and located at stent tips where leaflet commissures were attached. Noncylindrical geometry increased peak principal leaflet stresses by 16%. Using exact geometry from high-resolution scans, the 26-mm Sapien Transcatheter Heart Valve showed that peak stresses for both stent and leaflets were present at commissural tips where leaflets were attached. These regions would be prone to leaflet degeneration. Understanding stresses in first-generation transcatheter valves allows comparison to

Conscious Sedation Versus General Anesthesia in Transcatheter Aortic Valve Replacement: The German Aortic Valve Registry.

PubMed

Husser, Oliver; Fujita, Buntaro; Hengstenberg, Christian; Frerker, Christian; Beckmann, Andreas; Möllmann, Helge; Walther, Thomas; Bekeredjian, Raffi; Böhm, Michael; Pellegrini, Costanza; Bleiziffer, Sabine; Lange, Rüdiger; Mohr, Friedrich; Hamm, Christian W; Bauer, Timm; Ensminger, Stephan

2018-03-26

The aims of this study were to report on the use of local anesthesia or conscious sedation (LACS) and general anesthesia in transcatheter aortic valve replacement and to analyze the impact on outcome. Transcatheter aortic valve replacement can be performed in LACS or general anesthesia. Potential benefits of LACS, such as faster procedures and shorter hospital stays, need to be balanced with safety. A total of 16,543 patients from the German Aortic Valve Registry from 2011 to 2014 were analyzed, and propensity-matched analyses were performed to correct for potential selection bias. LACS was used in 49% of patients (8,121 of 16,543). In hospital, LACS was associated with lower rates of low-output syndrome, respiratory failure, delirium, cardiopulmonary resuscitation, and death. There was no difference in paravalvular leakage (II+) between LACS and general anesthesia in the entire population (5% vs. 4.8%; p = 0.76) or in the matched population (3.9% vs. 4.9%, p = 0.13). The risk for prolonged intensive care unit stay (≥3 days) was significantly reduced with LACS (odds ratio: 0.82; 95% confidence interval [CI]: 0.73 to 0.92; p = 0.001). Thirty-day mortality was lower with LACS in the entire population (3.5% vs. 4.9%; hazard ratio [HR]: 0.72; 95% CI: 0.60 to 0.86; p < 0.001) and in the matched population (2.8% vs. 4.6%; HR: 0.6; 95% CI: 0.45 to 0.8; p < 0.001). However, no differences in 1-year mortality between both groups in the entire population (16.5% vs. 16.9%; HR: 0.93; 95% CI: 0.85 to 1.02; p = 0.140) and in the propensity-matched population (14.1% vs. 15.5%; HR: 0.90; 95% CI: 0.78 to 1.03; p = 0.130) were observed. Use of LACS in transcatheter aortic valve replacement is safe, with fewer post-procedural complications and lower early mortality, suggesting its broad application. Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Sequential transcatheter aortic valve implantation due to valve dislodgement - a Portico valve implanted over a CoreValve bioprosthesis.

PubMed

Campante Teles, Rui; Costa, Cátia; Almeida, Manuel; Brito, João; Sondergaard, Lars; Neves, José P; Abecasis, João; M Gabriel, Henrique

2017-03-01

Transcatheter aortic valve implantation (TAVI) has become an important treatment in high surgical risk patients with severe aortic stenosis (AS), whose complications need to be managed promptly. The authors report the case of an 86-year-old woman presenting with severe symptomatic AS, rejected for surgery due to advanced age and comorbidities. The patient underwent a first TAVI, with implantation of a Medtronic CoreValve ® , which became dislodged and migrated to the ascending aorta. Due to the previous balloon valvuloplasty, the patient's AS became moderate, and her symptoms improved. After several months, she required another intervention, performed with a St. Jude Portico ® repositionable self-expanding transcatheter aortic valve. There was a good clinical response that was maintained at one-year follow-up. The use of a self-expanding transcatheter bioprosthesis with repositioning features is a solution in cases of valve dislocation to avoid suboptimal positioning of a second implant, especially when the two valves have to be positioned overlapping or partially overlapping each other. Copyright © 2017 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

Vancouver Transcatheter Aortic Valve Replacement Clinical Pathway: Minimalist Approach, Standardized Care, and Discharge Criteria to Reduce Length of Stay.

PubMed

Lauck, Sandra B; Wood, David A; Baumbusch, Jennifer; Kwon, Jae-Yung; Stub, Dion; Achtem, Leslie; Blanke, Philipp; Boone, Robert H; Cheung, Anson; Dvir, Danny; Gibson, Jennifer A; Lee, Bobby; Leipsic, Jonathan; Moss, Robert; Perlman, Gidon; Polderman, Jopie; Ramanathan, Krishnan; Ye, Jian; Webb, John G

2016-05-01

We describe the development, implementation, and evaluation of a standardized clinical pathway to facilitate safe discharge home at the earliest time after transfemoral transcatheter aortic valve replacement. Between May 2012 and October 2014, the Heart Team developed a clinical pathway suited to the unique requirements of transfemoral transcatheter aortic valve replacement in contemporary practice. The components included risk-stratified minimalist periprocedure approach, standardized postprocedure care with early mobilization and reconditioning, and criteria-driven discharge home. Our aim was to reduce variation in care, identify a subgroup of patients suitable for early discharge (≤48 hours), and decrease length of stay for all patients. We addressed barriers related to historical practices, complex multidisciplinary stakeholder engagement, and adoption of length of stay as a quality indicator. We retrospectively reviewed the experiences of 393 consecutive patients; 150 (38.2%) were discharged early. At baseline, early discharge patients had experienced less previous balloon aortic valvuloplasty, had higher left ventricular ejection fraction, better cognitive function, and were less frail than the standard discharge group (>48 hours). Early discharge was associated with the use of local anesthesia, implantation of balloon expandable device, avoidance of urinary catheter, and early removal of temporary pacemaker. Median length of stay was 1 day for early discharge and 3 days for other patients; 97.7% were discharged home. There were no differences in 30-day mortality (1.3%), disabling stroke (0.8%), or readmission (10.7%). The implementation of a transcatheter aortic valve replacement clinical pathway shifted the program's approach to combine standardized processes and individual risk stratification. The Vancouver transcatheter aortic valve replacement clinical pathway requires a rigorous assessment to determine its efficacy, safety, and reproducibility. �

The utility of trans-catheter aortic valve replacement after commercialization: does the European experience provide a glimpse into the future use of this technology in the United States?

PubMed

Linke, Axel; Walther, Thomas; Schuler, Gerhard

2010-03-01

Treatment of aortic stenosis remains challenging in older individuals, as their perioperative mortality for open heart surgery is increased due to comorbidities. Transcatheter aortic valve implantation using the CoreValve ReValving System (Medtronic, Minneapolis, USA) and the Edwards SAPIEN transcatheter heart valve (THV; Edwards Lifescience, Irvine, California, USA) represents an alternative to conventional valve replacement in elderly patients that have a high risk for conventional surgery. This article summarizes the evidence-base from recent clinical trials. The early results of these landmark studies suggest that transcatheter aortic valve implantation with either one of the prosthesis is feasible, safe, improves hemodynamics and, therefore, might be an alternative to conventional aortic valve replacement in very high-risk patients. However, all of the available transcatheter heart valves have certain disadvantages, limiting their use in daily clinical practice. The process of decision making, which valve to use and which access route to choose is illustrated in this article through clinical case scenarios. Additionally, the lessons learned thus far from the European perspective and the potential impact on the future use in the US are discussed. Despite of the progress in this field, we are still lacking an optimal transcatheter heart valve. Once it is available, we can take the plunge to compare transcatheter valve implantation with convention surgery in severe aortic stenosis!

Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery.

PubMed

Popma, Jeffrey J; Adams, David H; Reardon, Michael J; Yakubov, Steven J; Kleiman, Neal S; Heimansohn, David; Hermiller, James; Hughes, G Chad; Harrison, J Kevin; Coselli, Joseph; Diez, Jose; Kafi, Ali; Schreiber, Theodore; Gleason, Thomas G; Conte, John; Buchbinder, Maurice; Deeb, G Michael; Carabello, Blasé; Serruys, Patrick W; Chenoweth, Sharla; Oh, Jae K

2014-05-20

This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery. Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy. We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG). A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis). TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902). Copyright © 2014 American College of Cardiology Foundation. Published by

Gait Speed Predicts 30-Day Mortality After Transcatheter Aortic Valve Replacement: Results From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

PubMed

Alfredsson, Joakim; Stebbins, Amanda; Brennan, J Matthew; Matsouaka, Roland; Afilalo, Jonathan; Peterson, Eric D; Vemulapalli, Sreekanth; Rumsfeld, John S; Shahian, David; Mack, Michael J; Alexander, Karen P

2016-04-05

Surgical risk scores do not include frailty assessments (eg, gait speed), which are of particular importance for patients with severe aortic stenosis considering transcatheter aortic valve replacement. We assessed the association of 5-m gait speed with outcomes in a cohort of 8039 patients who underwent transcatheter aortic valve replacement (November 2011-June 2014) and were included in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. We evaluated the association between continuous and categorical gait speed and 30-day all-cause mortality before and after adjustment for Society of Thoracic Surgeons-predicted risk of mortality score and key variables. Secondary outcomes included in-hospital mortality, bleeding, acute kidney injury, and stroke. The overall median gait speed was 0.63 m/s (25th-75th percentile, 0.47-0.79 m/s), with the slowest walkers (<0.5 m/s) constituting 28%, slow walkers (0.5-0.83 m/s) making up 48%, and normal walkers (>0.83 m/s) constituting 24% of the population. Thirty-day all-cause mortality rates were 8.4%, 6.6%, and 5.4% for the slowest, slow, and normal walkers, respectively (P<0.001). Each 0.2-m/s decrease in gait speed corresponded to an 11% increase in 30-day mortality (adjusted odds ratio, 1.11; 95% confidence interval, 1.01-1.22). The slowest walkers had 35% higher 30-day mortality than normal walkers (adjusted odds ratio, 1.35; 95% confidence interval, 1.01-1.80), significantly longer hospital stays, and a lower probability of being discharged to home. Gait speed is independently associated with 30-day mortality after transcatheter aortic valve replacement. Identification of frail patients with the slowest gait speeds facilitates preprocedural evaluation and anticipation of a higher level of postprocedural care. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01737528. © 2016 American Heart Association, Inc.

Percutaneous coronary intervention in patients with severe aortic stenosis: implications for transcatheter aortic valve replacement.

PubMed

Goel, Sachin S; Agarwal, Shikhar; Tuzcu, E Murat; Ellis, Stephen G; Svensson, Lars G; Zaman, Tarique; Bajaj, Navkaranbir; Joseph, Lee; Patel, Neil S; Aksoy, Olcay; Stewart, William J; Griffin, Brian P; Kapadia, Samir R

2012-02-28

With the availability of transcatheter aortic valve replacement, management of coronary artery disease in patients with severe aortic stenosis (AS) is posing challenges. Outcomes of percutaneous coronary intervention (PCI) in patients with severe AS and coronary artery disease remain unknown. We sought to compare the short-term outcomes of PCI in patients with and without AS. From our PCI database, we identified 254 patients with severe AS who underwent PCI between 1998 and 2008. Using propensity matching, we found 508 patients without AS who underwent PCI in the same period. The primary end point of 30-day mortality after PCI was similar in patients with and without severe AS (4.3% [11 of 254] versus 4.7% [24 of 508]; hazard ratio, 0.93; 95% confidence interval, 0.51-1.69; P=0.2). Patients with low ejection fraction (≤30%) and severe AS had a higher 30-day post-PCI mortality compared with those with an ejection fraction >30% (5.4% [7 of 45] versus 1.2% [4 of 209]; P<0.001). In addition, AS patients with high Society of Thoracic Surgeons score (≥10) had a higher 30-day post-PCI mortality than those with a Society of Thoracic Surgeons score <10 (10.4% [10 of 96] versus 0%; P<0.001). PCI can be performed in patients with severe symptomatic AS and coronary artery disease without an increased risk of short-term mortality compared with propensity-matched patients without AS. Patients with ejection fraction ≤30% and Society of Thoracic Surgeons score ≥10% are at a highest risk of 30-day mortality after PCI. This finding has significant implications in the management of severe coronary artery disease in high-risk severe symptomatic AS patients being considered for transcatheter aortic valve replacement.

Transfemoral transcatheter aortic valve insertion-related intraoperative morbidity: Implications of the minimalist approach.

PubMed

Greason, Kevin L; Pochettino, Alberto; Sandhu, Gurpreet S; King, Katherine S; Holmes, David R

2016-04-01

Transfemoral transcatheter aortic valve insertion may be performed in a catheterization laboratory (ie, the minimalist approach). It seems reasonable when considering this approach to avoid it in patients at risk for intraoperative morbidity that would require surgical intervention. We hypothesized that it would be possible to associate baseline characteristics with such morbidity, which would help heart teams select patients for the minimalist approach. We reviewed the records of 215 consecutive patients who underwent transfemoral transcatheter aortic valve insertion with a current commercially available device from November 2008 through July 2015. Demographic characteristics of the patients included a mean age of 78.9 ± 10.6 years, female sex in 73 patients (34.0%), and a mean Society of Thoracic Surgeons predicted risk of mortality of 8.7% ± 5.4%. Valve prostheses were balloon-expandable in 126 patients (58.6%) and self-expanding in 89 patients (41.4%). Significant intraoperative morbidity occurred in 22 patients (10.2%) and included major vascular injury in 12 patients (5.6%), hemodynamic compromise requiring cardiopulmonary bypass support in 4 patients (1.9%), cardiac tamponade requiring intervention in 3 patients (1.4%), ventricular valve embolization in 2 patients (0.9%), and inability to obtain percutaneous access requiring open vascular access in 1 patient (0.5%). Intraoperative morbidity was similarly distributed across all valve types (P = .556) and sheath sizes (P = .369). There were no baseline patient characteristics predictive of intraoperative morbidity. Patient and valve characteristics are not predictive of significant intraoperative morbidity during transfemoral transcatheter aortic valve insertion. The finding has implications for patient selection for the minimalist approach. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Aortic annulus eccentricity before and after transcatheter aortic valve implantation: Comparison of balloon-expandable and self-expanding prostheses.

PubMed

Schuhbaeck, Annika; Weingartner, Christina; Arnold, Martin; Schmid, Jasmin; Pflederer, Tobias; Marwan, Mohamed; Rixe, Johannes; Nef, Holger; Schneider, Christian; Lell, Michael; Uder, Michael; Ensminger, Stephan; Feyrer, Richard; Weyand, Michael; Achenbach, Stephan

2015-07-01

The geometry of the aortic annulus and implanted transcatheter aortic valve prosthesis might influence valve function. We investigated the influence of valve type and aortic valve calcification on post-implant geometry of catheter-based aortic valve prostheses. Eighty consecutive patients with severe aortic valve stenosis (mean age 82 ± 6 years) underwent computed tomography before and after TAVI. Aortic annulus diameters were determined. Influence of prosthesis type and degree of aortic valve calcification on post-implant eccentricity were analysed. Aortic annulus eccentricity was reduced in patients after TAVI (0.21 ± 0.06 vs. 0.08 ± 0.06, p<0.0001). Post-TAVI eccentricity was significantly lower in 65 patients following implantation of a balloon-expandable prosthesis as compared to 15 patients who received a self-expanding prosthesis (0.06 ± 0.05 vs. 0.15 ± 0.07, p<0.0001), even though the extent of aortic valve calcification was not different. After TAVI, patients with a higher calcium amount retained a significantly higher eccentricity compared to patients with lower amounts of calcium. Patients undergoing TAVI with a balloon-expandable prosthesis show a more circular shape of the implanted prosthesis as compared to patients with a self-expanding prosthesis. Eccentricity of the deployed prosthesis is affected by the extent of aortic valve calcification. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Transcatheter heart valves for the treatment of aortic stenosis: state-of-the-art.

PubMed

Del Valle-Fernández, R; Ruiz, C E

2008-10-01

Degenerative aortic stenosis is the most frequent heart valve disease. As an alternative to surgical aortic valve replacement, several companies are working on the development of new prosthesis designed to be deployed by transcatheter approaches. Both transfemoral and transapical techniques are feasible, and initial trials in high-risk patients show good procedural outcomes and mid-term (up to 2 years) functionality. Two first-generation prosthesis (Edwards-SAPIEN and CoreValve Revalving System) are commercially available in Europe, and a number of other second-generation valves (with the capabilities of repositioning and retrievability) are under evaluation. Among them, the Sadra-Lotus Valve, The Direct Flow Medical valve and the Paniagua Heart Valve have published first-in-man results; the JenaValve and AorTx devices have also been temporarily implanted in humans. The development of repositionable and retrievable prosthesis with improved profile is mandatory, and it is the main focus of current projects. Not only technical improvements but also operators specialization and an optimal patient selection are essential to improve these initial Some procedural challenges need to be overcome prior to the expansion of these techniques to lower risk groups, and time is needed for detailed long-term outcomes and risk estimations. Only with a close collaboration among different specialists, basic researchers and the industry will the future development of transcatheter aortic implantation techniques be ensured.

The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation.

PubMed

Silaschi, Miriam; Conradi, Lenard; Wendler, Olaf; Schlingloff, Friederike; Kappert, Utz; Rastan, Ardawan J; Baumbach, Hardy; Holzhey, David; Eichinger, Walter; Bader, Ralf; Treede, Hendrik

2018-06-01

We present 1-year outcomes of the post-market registry of a next-generation transcatheter heart valve used for aortic regurgitation (AR). Transcatheter aortic valve replacement (TAVR) is routine in high-risk patients with aortic stenosis but is not recommended for AR. The JenaValve™ (JenaValve Technology GmbH, Munich, Germany) overcomes technical challenges in AR patients through a leaflet clipping mechanism. The JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere Aortic Stenosis oR Aortic Insufficiency (JUPITER) Registry is a European study to evaluate safety and effectiveness of this THV. From 2012-2015, 30 patients with AR were enrolled. Mean age was 74.4 ± 9.3 years. Procedural success was 96.7% (29/30). One patient was converted to open surgery. No annular rupture or coronary ostia obstruction occurred. Mortality at 30 days was 10.0% (3/30). Combined safety endpoint was met in 13.3% (4/30). Paravalvular regurgitation was not present/trivial in 84.6% (22/26) and mild in 15.4% (4/26). Rate of permanent pacemaker implantation was 3.8% (1/26). One-year Kaplan-Meier survival was 79.9%, one-year combined efficacy was 73.1% (19/30). No further strokes were observed during 1 year of follow-up. The JenaValve overcomes technical challenges of TAVR in AR through a clipping mechanism. We report satisfactory outcomes of a multicenter registry using the JenaValve for predominant AR, as rate of THV embolization, residual AR and permanent pacemaker implantation was low. One-year results using the JenaValve for AR encourage its use for this indication. © 2017 Wiley Periodicals, Inc.

Biomedical Impact in Implantable Devices-The Transcatheter Aortic Valve as an example

NASA Astrophysics Data System (ADS)

Anastasiou, Alexandros; Saatsakis, George

2015-09-01

Objective: To update of the scientific community about the biomedical engineering involvement in the implantable devices chain. Moreover the transcatheter Aortic Valve (TAV) replacement, in the field of cardiac surgery, will be analyzed as an example of contemporary implantable technology. Methods: A detailed literature review regarding biomedical engineers participating in the implantable medical product chain, starting from the design of the product till the final implantation technique. Results: The scientific role of biomedical engineers has clearly been established. Certain parts of the product chain are implemented almost exclusively by experienced biomedical engineers such as the transcatheter aortic valve device. The successful professional should have a multidisciplinary knowledge, including medicine, in order to pursue the challenges for such intuitive technology. This clearly indicates that biomedical engineers are among the most appropriate scientists to accomplish such tasks. Conclusions: The biomedical engineering involvement in medical implantable devices has been widely accepted by the scientific community, worldwide. Its important contribution, starting from the design and extended to the development, clinical trials, scientific support, education of other scientists (surgeons, cardiologists, technicians etc.), and even to sales, makes biomedical engineers a valuable player in the scientific arena. Notably, the sector of implantable devices is constantly raising, as emerging technologies continuously set up new targets.

Quantitative assessment of paravalvular leakage after transcatheter aortic valve replacement using a patient-specific pulsatile flow model.

PubMed

Tanaka, Yutaka; Saito, Shigeru; Sasuga, Saeko; Takahashi, Azuma; Aoyama, Yusuke; Obama, Kazuto; Umezu, Mitsuo; Iwasaki, Kiyotaka

2018-05-01

Quantitative assessment of post-transcatheter aortic valve replacement (TAVR) aortic regurgitation (AR) remains challenging. We developed patient-specific anatomical models with pulsatile flow circuit and investigated factors associated with AR after TAVR. Based on pre-procedural computed tomography (CT) data of the six patients who underwent transfemoral TAVR using a 23-mm SAPIEN XT, anatomically and mechanically equivalent aortic valve models were developed. Forward flow and heart rate of each patient in two days after TAVR were duplicated under mean aortic pressure of 80mmHg. Paravalvular leakage (PVL) volume in basal and additional conditions was measured for each model using an electromagnetic flow sensor. Incompletely apposed tract between the transcatheter and aortic valves was examined using a micro-CT. PVL volume in each patient-specific model was consistent with each patient's PVL grade, and was affected by hemodynamic conditions. PVL and total regurgitation volume increased with the mean aortic pressure, whereas closing volume did not change. In contrast, closing volume increased proportionately with heart rate, but PVL did not change. The minimal cross-sectional gap had a positive correlation with the PVL volumes (r=0.89, P=0.02). The gap areas typically occurred in the vicinity of the bulky calcified nodules under the native commissure. PVL volume, which could be affected by hemodynamic conditions, was significantly associated with the minimal cross-sectional gap area between the aortic annulus and the stent frame. These data may improve our understanding of the mechanism of the occurrence of post-TAVR PVL. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Transcatheter JenaValve Implantation in a Stentless Prosthesis: A Challenging Case After 4 Previous Aortic Procedures.

PubMed

Sponga, Sandro; Mazzaro, Enzo; Bagur, Rodrigo; Livi, Ugolino

2017-04-01

A 40-year-old man underwent 4 aortic surgeries because of endocarditis and subsequent prosthesis dehiscence. At the last recurrence he presented with acute severe aortic regurgitation of a Pericarbon Freedom (LivaNova plc, London, UK) stentless bioprosthesis and a morphologically disarranged aortic root. He also presented with left ventricular dysfunction and a very low origin of the left coronary artery. Therefore, a fifth redo aortic valve replacement was considered at high surgical risk. Accordingly, before listing the patient for a heart transplantation, a transcatheter valve-in-valve implantation with the JenaValve (JenaValve Technology, GmbH, Munich, Germany) prosthesis was performed. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Transfemoral aortic valve implantation in severe aortic stenosis patients with prior mitral valve prosthesis

PubMed Central

Sarı, Cenk; Baştuğ, Serdal; Kasapkara, Hacı Ahmet; Durmaz, Tahir; Keleş, Telat; Akçay, Murat; Aslan, Abdullah Nabi; Bayram, Nihal Akar; Bozkurt, Engin

2015-01-01

Introduction Transcatheter aortic valve implantation for severe symptomatic aortic stenosis in patients with a previous mitral valve prosthesis is technically challenging, and pre-procedural comprehensive assessment of these patients before transcatheter aortic valve implantation is vital for an uncomplicated and successful procedure. Aim We want to share our experience with transcatheter aortic valve implantation in patients with a preexisting functional mitral valve prosthesis and describe a series of important technical and pre-procedural details. Material and methods At our center, 135 patients with symptomatic severe aortic stenosis were treated with transcatheter aortic valve implantation. Six of them with a preexisting mitral valve prosthesis received an Edwards SAPIEN XT valve through the transfemoral route. Results Transcatheter aortic valve implantation was performed successfully in all 6 patients without any deformation of the cobalt-chromium/steel stents of the aortic valve bioprosthesis. Also no distortion or malfunction in the mitral valve prosthesis was observed after the procedure. There were no complications during the hospitalization period. Post-procedural echocardiography revealed no or mild aortic paravalvular regurgitation and normal valve function in all the patients. In addition, serial echocardiographic examination demonstrated that both the stability and function of the aortic and mitral prosthetic valves were normal without any deterioration in the gradients and the degree of the regurgitation at long-term follow-ups. Conclusions Our experience confirms that transcatheter aortic valve implantation is technically feasible in patients with previous mitral valve replacement but comprehensive evaluation of patients by multimodal imaging techniques such as transesophageal echocardiography and multislice computed tomography is mandatory for a successful and safe procedure. PMID:26677380

Transcatheter aortic valve implantation: durability of clinical and hemodynamic outcomes beyond 3 years in a large patient cohort.

PubMed

Gurvitch, R; Wood, D A; Tay, E L; Leipsic, J; Ye, J; Lichtenstein, S V; Thompson, C R; Carere, R G; Wijesinghe, N; Nietlispach, F; Boone, R H; Lauck, S; Cheung, A; Webb, J G

2010-09-28

Although short- and medium-term outcomes after transcatheter aortic valve implantation are encouraging, long-term data on valve function and clinical outcomes are limited. Consecutive high-risk patients who had been declined as surgical candidates because of comorbidities but who underwent successful transcatheter aortic valve implantation with a balloon-expandable valve between January 2005 and December 2006 and survived past 30 days were assessed. Clinical, echocardiographic, and computed tomographic follow-up examinations were performed. Seventy patients who underwent successful procedures and survived longer than 30 days were evaluated at a minimum follow-up of 3 years. At a median follow-up of 3.7 years (interquartile range 3.4 to 4.3 years), survival was 57%. Survival at 1, 2, and 3 years was 81%, 74%, and 61%, respectively. Freedom from reoperation was 98.5% (1 patient with endocarditis). During this early procedural experience, 11 patients died within 30 days, and 8 procedures were unsuccessful. When these patients were included, overall survival was 51%. Transaortic pressure gradients increased from 10.0 mm Hg (interquartile range 8.0 to 12.0 mm Hg) immediately after the procedure to 12.1 mm Hg (interquartile range 8.6 to 16.0 mm Hg) after 3 years (P=0.03). Bioprosthetic valve area decreased from a mean of 1.7±0.4 cm(2) after the procedure to 1.4±0.3 cm(2) after 3 years (P<0.01). Aortic incompetence after implantation was trivial or mild in 84% of cases and remained unchanged or improved over time. There were no cases of structural valvular deterioration, stent fracture, deformation, or valve migration. Transcatheter aortic valve implantation demonstrates good medium- to long-term durability and preserved hemodynamic function, with no evidence of structural failure. The procedure appears to offer an adequate and lasting resolution of aortic stenosis in selected patients.

1-Year Outcomes After Transcatheter Aortic Valve Replacement With Balloon-Expandable Versus Self-Expandable Valves: Results From the CHOICE Randomized Clinical Trial.

PubMed

Abdel-Wahab, Mohamed; Neumann, Franz-Josef; Mehilli, Julinda; Frerker, Christian; Richardt, Doreen; Landt, Martin; Jose, John; Toelg, Ralph; Kuck, Karl-Heinz; Massberg, Steffen; Robinson, Derek R; El-Mawardy, Mohamed; Richardt, Gert

2015-08-18

The use of a balloon-expandable transcatheter heart valve previously resulted in a greater rate of device success compared with a self-expandable transcatheter heart valve. The aim of this study was to evaluate clinical and echocardiographic outcome data at longer term follow-up. The investigator-initiated trial randomized 241 high-risk patients with symptomatic severe aortic stenosis and anatomy suitable for treatment with both balloon- and self-expandable transcatheter heart valves to transfemoral transcatheter aortic valve replacement with either device. Patients were followed-up for 1 year, with assessment of clinical outcomes and echocardiographic evaluation of valve function. At 1 year, the rates of death of any cause (17.4% vs. 12.8%; relative risk [RR]: 1.35; 95% confidence interval [CI]: 0.73 to 2.50; p = 0.37) and of cardiovascular causes (12.4% vs. 9.4%; RR: 1.32; 95% CI: 0.63 to 2.75; p = 0.54) were not statistically significantly different in the balloon- and self-expandable groups, respectively. The frequencies of all strokes (9.1% vs. 3.4%; RR: 2.66; 95% CI: 0.87 to 8.12; p = 0.11) and repeat hospitalization for heart failure (7.4% vs. 12.8%; RR: 0.58; 95% CI: 0.26 to 1.27; p = 0.19) did not statistically significantly differ between the 2 groups. Elevated transvalvular gradients during follow-up were observed in 4 patients in the balloon-expandable group (3.4% vs. 0%; p = 0.12); all were resolved with anticoagulant therapy, suggesting a thrombotic etiology. More than mild paravalvular regurgitation was more frequent in the self-expandable group (1.1% vs. 12.1%; p = 0.005). Despite the higher device success rate with the balloon-expandable valve, 1-year follow-up of patients in CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT Trial), with limited statistical power, revealed clinical outcomes after transfemoral transcatheter aortic valve

Aortic annulus and root characteristics in severe aortic stenosis due to bicuspid aortic valve and tricuspid aortic valves: implications for transcatheter aortic valve therapies.

PubMed

Philip, Femi; Faza, Nadine Nadar; Schoenhagen, Paul; Desai, Milind Y; Tuzcu, E Murat; Svensson, Lars G; Kapadia, Samir R

2015-08-01

Patients with severe aortic stenosis due to BAV are excluded from transcatheter aortic valve replacement (TAVR) due to concern for asymmetric expansion and valve dysfunction. We sought to characterize the aortic root and annulus in bicuspid aortic valve (BAV) and tricuspid aortic valves (TAV). We identified patients with severe AS who underwent multi-detector computed tomographic (MDCT) imaging prior to surgical aortic valve replacement (SAVR, n = 200) for BAV and TAVR (n = 200) for TAV from 2010 to 2013. The presence of a BAV was confirmed on surgical and pathological review. Annulus measurements of the basal ring (short- and long-axis, area-derived diameter), coronary ostia height, sinus area (SA), sino-tubular junction area (STJ), calcification and eccentricity index (EI, 1-short axis/long axis) were made. Patients with TAV were older (78.8 years vs. 57.8 years, P = 0.04) than those with BAV. The aortic annulus area (5.21 ± 2.1 cm(2) vs. 4.63 ± 2.0 cm(2) , P = 0.0001), sinus of Valsalva diameter (3.7 ± 0.9 cm vs. 3.1 ± 0.1 cm, P = 0.001) and ascending aorta diameter (3.5 ± 0.7 cm vs. 2.97 ± 0.6 cm, P = 0.001) were significantly larger with BAV. Bicuspid aortic annuli were significantly less elliptical (EI, 1.24 ± 0.1 vs. 1.29 ± 0.1, P = 0.006) and more circular (39% vs. 4%, P < 0.001) compared to the TAV annulus. There was more eccentric annular calcification in BAV vs. TAV (68% vs. 32%, P < 0.001). The mean distance from the aortic annulus to the left main coronary ostium was less than the right coronary ostium. Less than 10% of the BAV annuli would not fit a currently available valved stents. Bicuspid aortic valves have a larger annulus size, sinus of Valsalva and ascending aorta dimensions. In addition, the BAV aortic annuli appear circular and most will fit currently available commercial valved stents. © 2015 Wiley Periodicals, Inc.

Evolution of Cognitive Function After Transcatheter Aortic Valve Implantation.

PubMed

Schoenenberger, Andreas W; Zuber, Chantal; Moser, André; Zwahlen, Marcel; Wenaweser, Peter; Windecker, Stephan; Carrel, Thierry; Stuck, Andreas E; Stortecky, Stefan

2016-10-01

This study aimed to assess the evolution of cognitive function after transcatheter aortic valve implantation (TAVI). Previous smaller studies reported conflicting results on the evolution of cognitive function after TAVI. In this prospective cohort, cognitive function was measured in 229 patients ≥70 years using the Mini Mental State Examination before and 6 months after TAVI. Cognitive deterioration or improvement was defined as change of ≥3 points decrease or increase in the Mini Mental State Examination score between baseline and follow-up. Cognitive deterioration was found in 29 patients (12.7%). Predictive analysis using logistic regression did not identify any statistically significant predictor of cognitive deterioration. A review of individual medical records in 8 patients with a major Mini Mental State Examination score decrease of ≥5 points revealed specific causes in 6 cases (postinterventional delirium in 2; postinterventional stroke, progressive renal failure, progressive heart failure, or combination of preexisting cerebrovascular disease and mild cognitive impairment in 1 each). Among 48 patients with impaired baseline cognition (Mini Mental State Examination score <26 points), 18 patients (37.5%) cognitively improved. The preinterventional aortic valve area was lower in patients who cognitively improved (median aortic valve area 0.60 cm 2 ) as compared with patients who did not improve (median aortic valve area 0.70 cm 2 ; P=0.01). This is the first study providing evidence that TAVI results in cognitive improvement among patients who had impaired preprocedural cognitive function, possibly related to hemodynamic improvement in patients with severe aortic stenosis. Our results confirm that some patients experience cognitive deterioration after TAVI. © 2016 American Heart Association, Inc.

Five-year follow-up after transcatheter aortic valve implantation for symptomatic aortic stenosis.

PubMed

Zahn, Ralf; Werner, Nicolas; Gerckens, Ulrich; Linke, Axel; Sievert, Horst; Kahlert, Philipp; Hambrecht, Rainer; Sack, Stefan; Abdel-Wahab, Mohamed; Hoffmann, Ellen; Zeymer, Uwe; Schneider, Steffen

2017-12-01

Transcatheter aortic valve implantation (TAVI) has been implemented into the care of elderly patients suffering from severe symptomatic aortic stenosis. However, data on long-term follow-up are sparse and predictors of long-term mortality need to be evaluated to better select patients. Therefore, we aimed to analyse predictors of 5-year mortality after TAVI. We analysed data from the German Transcatheter Aortic Valve Interventions-Registry. Each of the 27 participating hospitals agreed to include all consecutive TAVI patients at their institution. Out of 1444 patients treated with TAVI, 1378 patients had a follow-up of at least 4.5 years (completeness 95.4%). Endpoint for this analysis was 5-year survival. Cox regression analysis was used to determine risk factors associated with this endpoint. Patients who died were compared with survivors. The two groups showed multiple differences in patient characteristics, indications for interventions, preinterventional, as well as interventional characteristics and postinterventional events. Calculated 1-year mortality was 21.8% and 5-year mortality 59.1%. A higher logistic EuroScore was associated with a lower 5-year survival, being 45.5% in patients with a logistic EuroScore of <20%, 34.5% in those with 20% to 40% and 28.4% in patients with a logistic EuroScore >40%. Cox proportional hazard analysis revealed the following independent predictors of 5-year mortality: female gender (HR =0.66, 95% CI 0.56 to 0.77, p<0.0001), renal failure (HR=1.43, 95% CI 1.22 to 1.69, p<0.0001), prior mitral regurgitation ≥II° (HR=1.42, 95% CI 1.21 to 1.65, p<0.0001), residual aortic regurgitation ≥II° (HR=1.52, 95% CI 1.24 to 1.85, p<0.0001), atrial fibrillation (HR=1.38, 95% CI 1.18 to 1.64, p=0.0001), low gradient aortic stenosis (HR=1.48, 95% CI 1.19 to 1.84, p=0.0004), prior decompensation (HR=1.32, 95% CI 1.13 to 1.54, p=0.0006), frailty (HR=1.31, 95% CI 1.09 to 1.58, p=0.004), surgical TAVI (HR=1.42, 95% CI 1

Relationship of aortic annular eccentricity and paravalvular regurgitation post transcatheter aortic valve implantation with CoreValve.

PubMed

Wong, Dennis T L; Bertaso, Angela G; Liew, Gary Y H; Thomson, Viji S; Cunnington, Michael S; Richardson, James D; Gooley, Robert; Lockwood, Siobhan; Meredith, Ian T; Worthley, Matthew I; Worthley, Stephen G

2013-04-01

Significant paravalvular aortic regurgitation (PAR) after transcatheter aortic valve implantation (TAVI) is associated with negative clinical consequences. We hypothesize that increased eccentricity of the aortic annulus is associated with greater PAR. Patients with severe aortic stenosis underwent multidetector computed tomography (MDCT) before successful TAVI with the Medtronic CoreValve bioprosthesis. The smallest (D(min)) and largest (D(max)) orthogonal diameters in the basal ring of the aortic annulus were determined. We defined circularity of aortic annulus using the eccentricity index (1 - D(min)/D(max)). The primary endpoint was early occurrence of significant PAR, defined as > grade II PAR by postprocedural aortography. Eighty-four patients, mean age 83 ± 4 years with a mean aortic valve area of 0.7 ± 0.2 cm² were included. Twenty patients had postprocedural PAR > grade II. Using a receiver operating characteristic (ROC) analysis, eccentricity index correlated with significant PAR (AUC = 0.834; P=.034). A retrospectively determined eccentricity index cut-off of >0.25 was related to significant PAR with a sensitivity of 80%, specificity of 86%, and negative predictive value of 95% (P<.001). On univariate logistic regression, eccentricity index of >0.25 (P<.001) and device implantation depth (P=.015) correlated with significant PAR, while other parameters such as annular calcification and cover index did not. On multivariate analysis including only parameters with P<.1 on univariate analysis, eccentricity index >0.25 was the sole independent predictor of significant PAR. Eccentricity index is related to significant PAR after TAVI with Medtronic CoreValve. Further larger studies are required to determine the utility of this novel index in screening suitable patients for this procedure.

Periprocedural considerations of transcatheter aortic valve implantation for anesthesiologists

PubMed Central

Afshar, Ata Hassani; Pourafkari, Leili; Nader, Nader D

2016-01-01

Transcatheter aortic valve replacement (TAVR) is rapidly gaining popularity as a viable option in the management of patients with symptomatic aortic stenosis (AS) and high risk for open surgical intervention. TAVR soon expanding its indications from "high-risk" group of patients to those with "intermediate-risk". As an anesthesiologist; understanding the procedure and the challenges inherent to it is of utmost importance, in order to implement optimal care for this generally frail population undergoing a rather novel procedure. Cardiac anesthesiologists generally play a pivotal role in the perioperative care of the patients, and therefore they should be fully familiar with the circumstances occurring surrounding the procedure. Along with increasing experience and technical developments for TAVR, the procedure time becomes shorter. Due to this improvement in the procedure time, more and more anesthesiologists feel comfortable in using monitored anesthesia care with moderate sedation for patients undergoing TAVR. A number of complications could arise during the procedure needing rapid diagnoses and occasionally conversion to general anesthesia. This review focuses on the periprocedural anesthetic considerations for TAVR. PMID:27489596

Association of aortic valve calcification severity with the degree of aortic regurgitation after transcatheter aortic valve implantation.

PubMed

Koos, Ralf; Mahnken, Andreas Horst; Dohmen, Guido; Brehmer, Kathrin; Günther, Rolf W; Autschbach, Rüdiger; Marx, Nikolaus; Hoffmann, Rainer

2011-07-15

This study sought to examine a possible relationship between the severity of aortic valve calcification (AVC), the distribution of AVC and the degree of aortic valve regurgitation (AR) after transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS). 57 patients (22 men, 81 ± 5 years) with symptomatic AS and with a logistic EuroSCORE of 24 ± 12 were included. 38 patients (67%) received a third (18F)-generation CoreValve® aortic valve prosthesis, in 19 patients (33%) an Edwards SAPIEN™ prosthesis was implanted. Prior to TAVI dual-source computed tomography for assessment of AVC was performed. To determine the distribution of AVC the percentage of the calcium load of the most severely calcified cusp was calculated. After TAVI the degree of AR was determined by angiography and echocardiography. The severity of AR after TAVI was related to the severity and distribution of AVC. There was no association between the distribution of AVC and the degree of paravalvular AR after TAVI as assessed by angiography (r = -0.02, p = 0.88). Agatston AVC scores were significantly higher in patients with AR grade ≥ 3 (5055 ± 1753, n = 3) than in patients with AR grade < 3 (1723 ± 967, p = 0.03, n = 54). Agatston AVC scores > 3000 were associated with a relevant paravalvular AR and showed a trend for increased need for second manoeuvres. There was a significant correlation between the severity of AVC and the degree of AR after AVR (r = 0.50, p < 0.001). Patients with severe AVC have an increased risk for a relevant AR after TAVI as well as a trend for increased need for additional procedures. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Sleep in octogenarians during the postoperative phase after transcatheter or surgical aortic valve replacement

PubMed Central

Amofah, Hege Andersen; Broström, Anders; Fridlund, Bengt; Bjorvatn, Bjørn; Haaverstad, Rune; Hufthammer, Karl Ove; Kuiper, Karel KJ; Ranhoff, Anette Hylen; Norekvål, Tone M

2015-01-01

Background: Octogenarians with aortic stenosis are an increasing population of patients admitted for surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI). Although adequate sleep is important after illness and surgery, it has scarcely been studied in the immediate postoperative phase. Aims: To determine and compare the nature of self-reported sleep and insomnia, and recorded sleep–wake patterns in octogenarians during the in-hospital postoperative phase after SAVR or TAVI. Methods: A prospective cohort design was used that included octogenarian patients undergoing SAVR or TAVI at a regional university hospital. Self-reports were used to document sleep and insomnia, and actigraphy was used to record sleep–wake patterns. Data were collected at baseline preoperatively, and then daily for the first five postoperative days. Results: SAVR patients experienced the most insomnia on postoperative nights later in recovery, while TAVI patients experienced the most insomnia on postoperative nights early in recovery. The median total sleep time, as measured by actigraphy, was 6.4 h, and the median sleep efficiency was 79% for the five postoperative nights, but no differences were found between SAVR and TAVI patients on this parameter. All patients slept more during daytime than at night, with SAVR patients having significantly more total sleep hours for all five days than TAVI patients (p < 0.01). Conclusion: Octogenarians with aortic stenosis had disturbed self-reported sleep, increased insomnia, and disturbed sleep–wake patterns postoperatively, resulting in more daytime sleep and inactivity. In patients undergoing SAVR or TAVI, sleep evolves differently during the in-hospital postoperative phase. PMID:26635329

The power of disruptive technological innovation: Transcatheter aortic valve implantation.

PubMed

Berlin, David B; Davidson, Michael J; Schoen, Frederick J

2015-11-01

We sought to evaluate the principles of disruptive innovation, defined as technology innovation that fundamentally shifts performance and utility metrics, as applied to transcatheter aortic valve implantation (TAVI). In particular, we considered implantation procedure, device design, cost, and patient population. Generally cheaper and lower performing, classical disruptive innovations are first commercialized in insignificant markets, promise lower margins, and often parasitize existing usage, representing unattractive investments for established market participants. However, despite presently high unit cost, TAVI is less invasive, treats a "new," generally high risk, patient population, and is generally done by a multidisciplinary integrated heart team. Moreover, at least in the short-term TAVI has not been lower-performing than open surgical aortic valve replacement in high-risk patients. We conclude that TAVI extends the paradigm of disruptive innovation and represents an attractive commercial opportunity space. Moreover, should the long-term performance and durability of TAVI approach that of conventional prostheses, TAVI will be an increasingly attractive commercial opportunity. © 2014 Wiley Periodicals, Inc.

Transfemoral Implantation of a Fully Repositionable and Retrievable Transcatheter Valve for Noncalcified Pure Aortic Regurgitation.

PubMed

Schofer, Joachim; Nietlispach, Fabian; Bijuklic, Klaudija; Colombo, Antonio; Gatto, Fernando; De Marco, Federico; Mangieri, Antonio; Hansen, Lorenz; Bruschi, Giuseppe; Ruparelia, Neil; Rieß, Friedrich-Christian; Maisano, Franscesco; Latib, Azeem

2015-12-21

This study sought to evaluate the use of the Direct Flow Medical (DFM) transcatheter heart valve (Direct Flow Medical, Santa Rosa, California) for the treatment of noncalcific pure aortic regurgitation (AR). The treatment of noncalcific AR has remained a relative contraindication with transcatheter heart valves due to challenges in anchoring devices in the absence of calcium, concerns of valve embolization, and the high risk of significant residual paravalvular leak. The study population consisted of patients treated for severe noncalcific pure AR with transfemoral implantation of a DFM transcatheter heart valve at 6 European centers. The primary endpoint was the composite endpoint of device success and the secondary endpoint was the composite early safety endpoint (according to the VARC-2 criteria). Eleven high-risk (STS score 8.84 ± 8.9, Logistic EuroSCORE 19.9 ± 7.1) patients (mean age 74.7 ± 12.9 years) were included. Device success was achieved in all patients. In 1 patient, the initial valve prosthesis was retrieved after pull-through, and a second valve was successfully deployed. The early safety endpoint was reached in 91% of the patients, with 1 patient requiring surgical aortic valve replacement secondary to downward dislocation of the prosthesis that was successfully managed with surgical aortic valve replacement. DFM implantation resulted in excellent hemodynamics with none or trivial paravalvular regurgitation in 9 patients and a transprosthetic gradient of 7.7 ± 5.1 mm Hg at 30-day follow up. All patients derived symptomatic benefit following the procedure, with 72% in New York Heart Association functional class I or II. This study reports the feasibility of treating severe noncalcific AR with the Direct Flow prosthesis via the transfemoral route. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients.

PubMed

Reardon, Michael J; Van Mieghem, Nicolas M; Popma, Jeffrey J; Kleiman, Neal S; Søndergaard, Lars; Mumtaz, Mubashir; Adams, David H; Deeb, G Michael; Maini, Brijeshwar; Gada, Hemal; Chetcuti, Stanley; Gleason, Thomas; Heiser, John; Lange, Rüdiger; Merhi, William; Oh, Jae K; Olsen, Peter S; Piazza, Nicolo; Williams, Mathew; Windecker, Stephan; Yakubov, Steven J; Grube, Eberhard; Makkar, Raj; Lee, Joon S; Conte, John; Vang, Eric; Nguyen, Hang; Chang, Yanping; Mugglin, Andrew S; Serruys, Patrick W J C; Kappetein, Arie P

2017-04-06

Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement. A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group. TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number

Transcatheter Aortic Valve Implantation for Treatment of Aortic Valve Stenosis: A Health Technology Assessment

PubMed Central

Sehatzadeh, Shayan; Tu, Hong-Anh; Holubowich, Corinne; Higgins, Caroline

2016-01-01

Background Surgical aortic valve replacement (SAVR) is the gold standard for treating aortic valve stenosis. It is a major operation that requires sternotomy and the use of a heart-lung bypass machine, but in appropriately selected patients with symptomatic, severe aortic valve stenosis, the benefits of SAVR usually outweigh the harms. Transcatheter aortic valve implantation (TAVI) is a less invasive procedure that allows an artificial valve to be implanted over the poorly functioning valve. Methods We identified and analyzed randomized controlled trials that evaluated the effectiveness and safety of TAVI compared with SAVR or balloon aortic valvuloplasty and were published before September 2015. The quality of the body of evidence for each outcome was examined according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. The overall quality was determined to be high, moderate, low, or very low using a step-wise, structural methodology. We also developed a Markov decision-analytic model to assess the cost-effectiveness of TAVI compared with SAVR over a 5-year time horizon, and we conducted a 5-year budget impact analysis. Results Rates of cardiovascular and all-cause mortality were similar for the TAVI and SAVR groups in all studies except one, which reported significantly lower all-cause mortality in the TAVI group and a higher rate of stroke in the SAVR group. Trials of high-risk patients who were not suitable candidates for SAVR showed significantly better survival with TAVI than with balloon aortic valvuloplasty. Median survival in the TAVI group was 31 months, compared with 11.7 months in the balloon aortic valvuloplasty group. Compared with SAVR, TAVI was associated with a significantly higher risk of stroke, major vascular complications, paravalvular aortic regurgitation, and the need for a permanent pacemaker. SAVR was associated with a higher risk of bleeding. Transapical TAVI was associated with higher

The importance of echocardiography in transcatheter aortic valve implantation.

PubMed

Bilen, Emine; Sari, Cenk; Durmaz, Tahir; Keleş, Telat; Bayram, Nihal A; Akçay, Murat; Ayhan, Hüseyin M; Bozkurt, Engin

2014-01-01

Valvular heart diseases cause serious health problems in Turkey as well as in Western countries. According to a study conducted in Turkey, aortic stenosis (AS) is second after mitral valve disease among all valvular heart diseases. AS is frequently observed in elderly patients who have several cardiovascular risk factors and comorbidities. In symptomatic severe AS, surgical aortic valve replacement (AVR) is a definitive treatment. However, in elderly patients with left ventricular dysfunction and comorbidities, the risk of operative morbidity and mortality increases and outweighs the gain obtained from AVR surgery. As a result, almost one-third of the patients with serious AS are considered ineligible for surgery. Transcatheter aortic valve implantation (TAVI) is an effective treatment in patients with symptomatic severe AS who have high risk for conventional surgery. Since being performed for the first time in 2002, with a procedure success rate reported as 95% and a mortality rate of 5%, TAVI has become a promising method. Assessment of vascular anatomy, aortic annular diameter, and left ventricular function may be useful for the appropriate selection of patients and may reduce the risk of complications. Cardiac imaging methods including 2D and 3D echocardiography and multidetector computed tomography are critical during the evaluation of suitable patients for TAVI as well as during and after the procedure. In this review, we describe the role of echocardiography methods in clinical practice for TAVI procedure in its entirety, i.e. from patient selection to guidance during the procedure, and subsequent monitoring. © 2013, Wiley Periodicals, Inc.

Patient selection for transcatheter aortic valve replacement: A combined clinical and multimodality imaging approach

PubMed Central

Cocchia, Rosangela; D’Andrea, Antonello; Conte, Marianna; Cavallaro, Massimo; Riegler, Lucia; Citro, Rodolfo; Sirignano, Cesare; Imbriaco, Massimo; Cappelli, Maurizio; Gregorio, Giovanni; Calabrò, Raffaele; Bossone, Eduardo

2017-01-01

Transcatheter aortic valve replacement (TAVR) has been validated as a new therapy for patients affected by severe symptomatic aortic stenosis who are not eligible for surgical intervention because of major contraindication or high operative risk. Patient selection for TAVR should be based not only on accurate assessment of aortic stenosis morphology, but also on several clinical and functional data. Multi-Imaging modalities should be preferred for assessing the anatomy and the dimensions of the aortic valve and annulus before TAVR. Ultrasounds represent the first line tool in evaluation of this patients giving detailed anatomic description of aortic valve complex and allowing estimating with enough reliability the hemodynamic entity of valvular stenosis. Angiography should be used to assess coronary involvement and plan a revascularization strategy before the implant. Multislice computed tomography play a central role as it can give anatomical details in order to choice the best fitting prosthesis, evaluate the morphology of the access path and detect other relevant comorbidities. Cardiovascular magnetic resonance and positron emission tomography are emergent modality helpful in aortic stenosis evaluation. The aim of this review is to give an overview on TAVR clinical and technical aspects essential for adequate selection. PMID:28400918

3D echocardiographic analysis of aortic annulus for transcatheter aortic valve replacement using novel aortic valve quantification software: Comparison with computed tomography.

PubMed

Mediratta, Anuj; Addetia, Karima; Medvedofsky, Diego; Schneider, Robert J; Kruse, Eric; Shah, Atman P; Nathan, Sandeep; Paul, Jonathan D; Blair, John E; Ota, Takeyoshi; Balkhy, Husam H; Patel, Amit R; Mor-Avi, Victor; Lang, Roberto M

2017-05-01

With the increasing use of transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis (AS), computed tomography (CT) remains the standard for annulus sizing. However, 3D transesophageal echocardiography (TEE) has been an alternative in patients with contraindications to CT. We sought to (1) test the feasibility, accuracy, and reproducibility of prototype 3DTEE analysis software (Philips) for aortic annular measurements and (2) compare the new approach to the existing echocardiographic techniques. We prospectively studied 52 patients who underwent gated contrast CT, procedural 3DTEE, and TAVR. 3DTEE images were analyzed using novel semi-automated software designed for 3D measurements of the aortic root, which uses multiplanar reconstruction, similar to CT analysis. Aortic annulus measurements included area, perimeter, and diameter calculations from these measurements. The results were compared to CT-derived values. Additionally, 3D echocardiographic measurements (3D planimetry and mitral valve analysis software adapted for the aortic valve) were also compared to the CT reference values. 3DTEE image quality was sufficient in 90% of patients for aortic annulus measurements using the new software, which were in good agreement with CT (r-values: .89-.91) and small (<4%) inter-modality nonsignificant biases. Repeated measurements showed <10% measurements variability. The new 3D analysis was the more accurate and reproducible of the existing echocardiographic techniques. Novel semi-automated 3DTEE analysis software can accurately measure aortic annulus in patients with severe AS undergoing TAVR, in better agreement with CT than the existing methodology. Accordingly, intra-procedural TEE could potentially replace CT in patients where CT carries significant risk. © 2017, Wiley Periodicals, Inc.

Multidetector computed tomography sizing of aortic annulus prior to transcatheter aortic valve replacement (TAVR): Variability and impact of observer experience.

PubMed

Le Couteulx, S; Caudron, J; Dubourg, B; Cauchois, G; Dupré, M; Michelin, P; Durand, E; Eltchaninoff, H; Dacher, J-N

2018-05-01

To evaluate intra- and inter-observer variability of multidetector computed tomography (MDCT) sizing of the aortic annulus before transcatheter aortic valve replacement (TAVR) and the effect of observer experience, aortic valve calcification and image quality. MDCT examinations of 52 consecutive patients with tricuspid aortic valve (30 women, 22 men) with a mean age of 83±7 (SD) years (range: 64-93 years) were evaluated retrospectively. The maximum and minimum diameters, area and circumference of the aortic annulus were measured twice at diastole and systole with a standardized approach by three independent observers with different levels of experience (expert [observer 1]; resident with intensive 6 months practice [observer 2]; trained resident with starting experience [observer 3]). Observers were requested to recommend the valve prosthesis size. Calcification volume of the aortic valve and signal to noise ratio were evaluated. Intra- and inter-observer reproducibility was excellent for all aortic annulus dimensions, with an intraclass correlation coefficient ranging respectively from 0.84 to 0.98 and from 0.82 to 0.97. Agreement for selection of prosthesis size was almost perfect between the two most experienced observers (k=0.82) and substantial with the inexperienced observer (k=0.67). Aortic valve calcification did not influence intra-observer reproducibility. Image quality influenced reproducibility of the inexperienced observer. Intra- and inter-observer variability of aortic annulus sizing by MDCT is low. Nevertheless, the less experienced observer showed lower reliability suggesting a learning curve. Copyright © 2017. Published by Elsevier Masson SAS.

[Anesthetic management and experience in the transcatheter implantation of the CoreValve(®) self-expanding aortic valve].

PubMed

Fernández Suárez, F E; del Valle Fernández, R; González Alvarez, A; Sánchez Lasheras, J; Fernández Sánchez, L; Argüelles Tamargo, L

2013-10-01

To analyze the experience and anesthetic management in the transcatheter implantation of the CoreValve(®) self-expanding aortic valve, in a university tertiary hospital. Observational analytical review of data incorporated into a prospectively maintained database of 142 patients diagnosed with severe aortic stenosis who underwent implantation of a CoreValve(®) aortic self-expanding aortic valve between December 2007 and December 2012. The mean age of patients was 82.5±6.1 years and the logistic EuroSCORE was 14.9±11.2. General anesthesia was used in 107 patients (75.3%), with local anesthesia with sedation in 35 (24.6%). Local anesthesia and sedation was associated with a lower requirement of vasoactive drugs (P=.003) during implantation. No statistically significant differences were found between the 2 anesthetic techniques in the duration of the procedure, hospital stay, or morbimortality. The success rate was 97.1%. The most common complication was conduction disorders that required implantation of a permanent pacemaker in 46 patients (32.3%). There was no intraoperative mortality, and all-cause mortality at 30 days was 6.3%, with a one-year survival estimated by the Kaplan-Meier of 83.1%. This study confirms that in patients with severe aortic stenosis and high surgical risk, transcatheter implantation of aortic valve is a safe and effective alternative. Both, general anesthesia and local anesthesia with sedation are valid options, depending on the experience of the team. Copyright © 2013 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Published by Elsevier España. All rights reserved.

3D Printing Based on Cardiac CT Assists Anatomic Visualization Prior to Transcatheter Aortic Valve Replacement

PubMed Central

Ripley, Beth; Kelil, Tatiana; Cheezum, Michael K.; Goncalves, Alexandra; Di Carli, Marcelo F.; Rybicki, Frank J.; Steigner, Mike; Mitsouras, Dimitrios; Blankstein, Ron

2017-01-01

Background 3D printing is a promising technique that may have applications in medicine, and there is expanding interest in the use of patient-specific 3D models to guide surgical interventions. Objective To determine the feasibility of using cardiac CT to print individual models of the aortic root complex for transcatheter aortic valve replacement (TAVR) planning as well as to determine the ability to predict paravalvular aortic regurgitation (PAR). Methods This retrospective study included 16 patients (9 with PAR identified on blinded interpretation of post-procedure trans-thoracic echocardiography and 7 age, sex, and valve size-matched controls with no PAR). 3D printed models of the aortic root were created from pre-TAVR cardiac computed tomography data. These models were fitted with printed valves and predictions regarding post-implant PAR were made using a light transmission test. Results Aortic root 3D models were highly accurate, with excellent agreement between annulus measurements made on 3D models and those made on corresponding 2D data (mean difference of −0.34 mm, 95% limits of agreement: ± 1.3 mm). The 3D printed valve models were within 0.1 mm of their designed dimensions. Examination of the fit of valves within patient-specific aortic root models correctly predicted PAR in 6 of 9 patients (6 true positive, 3 false negative) and absence of PAR in 5 of 7 patients (5 true negative, 2 false positive). Conclusions Pre-TAVR 3D-printing based on cardiac CT provides a unique patient-specific method to assess the physical interplay of the aortic root and implanted valves. With additional optimization, 3D models may complement traditional techniques used for predicting which patients are more likely to develop PAR. PMID:26732862

Outcomes following transcatheter aortic valve replacement in patients with native aortic valve regurgitation

PubMed Central

Bob-Manuel, Tamunoinemi; Kadire, Siri; Heckle, Mark R.; Wang, Jiajing

2018-01-01

Due to the absence of annular calcification for device anchoring, it is presumed that transcatheter aortic valve replacement (TAVR) is not suitable for the treatment of native aortic valve regurgitation (NAVR) resulting in very limited data and experience concerning its safety and efficacy. We sought to review published data on the safety and efficacy of TAVR in high-risk patients with NAVR. Studies including case reports, case series and original articles published between 2002 and 2016 on TAVR in patients with NAVR were identified with a systematic electronic search using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Only studies reporting data on demographic and procedural characteristics, management and follow up outcomes were analyzed. A total of 30 publications describing 182 patients were identified. Most patients (54%) were men, with a mean age of 70.1±2.6 years, mean logistic European System for Cardiac Operative Risk Evaluation score (EuroSCORE) of 21.8%±4.5% and mean Society of Thoracic Surgeons (STS) score of 8%±1.8% for mortality. The majority (87%) of patients had severe NAVR with no valvular calcification. TAVR was mostly performed through the femoral (58.8%) and apical (33.1%) approach. Device success, defined by VARC-2, was achieved in 86.3% of our study population. A second valve was required in 17 patients (9.3%) during the index procedure for residual aortic regurgitation or malposition. Post-procedure aortic regurgitation of grade 1 or less was present in 80 patients (81%). Pacemaker implantation was required post procedure in 17 patients (9.3%). The 30-day and 1-year mortality was 11.9% and 16.2%, respectively. TAVR is associated with favorable pacemaker implantation and 1-year mortality rates with a high 30-day mortality among selected patients with NAVR. PMID:29404354

Salvaging catastrophe in transcatheter aortic valve implantation: rehearsal, preassigned roles, and emergency preparedness.

PubMed

Tam, Derrick Y; Jones, Philip M; Kiaii, Bob; Diamantouros, Pantelis; Teefy, Patrick; Bainbridge, Daniel; Cleland, Andrew; Fernandes, Philip; Chu, Michael W A

2015-08-01

Emergency rescue plans for acute complications during transcatheter aortic valve implantation (TAVI) commonly include cardiopulmonary resuscitation, femoro-femoral cardiopulmonary bypass (CPB), and hemodynamic stabilization before definitive intervention is achieved. Nevertheless, most cases of emergency resuscitation remain chaotic and disorganized and often take longer than necessary, even in experienced centres. We sought to determine which factors and procedures may be associated with improved patient outcomes when emergencies arise during TAVI. MEDLINE(®) and EMBASE™ were searched with the following key words: "TAVI" or "TAVR" or "transcatheter valve implantation" or "transcatheter valve replacement" and "emergency cardiac surgery" or "conversion". Two hundred seventeen articles met the criteria and were reviewed. Utilization of a formal emergency checklist by a multidisciplinary TAVI team may reduce procedural errors, smooth the transition to CPB, and ultimately speed the delivery of corrective measures including emergency cardiac surgery. A well-organized regularly-rehearsed emergency rescue plan that preassigns resuscitative roles may shorten the duration of patient instability and resuscitation and improve patient outcomes when catastrophe occurs in TAVI. The anesthesia team plays a central role in preventing, detecting, and treating intraprocedural complications during TAVI.

Assisted care as a baseline patient risk characteristic affecting the outcome of transcatheter aortic valve insertion.

PubMed

Traynor, Megan M; Greason, Kevin L; Nkomo, Vuyisile T; Pochettino, Alberto; Holmes, David R; Rihal, Charanjit S; Reeder, Guy S; Bresnahan, John F; Mathew, Verghese

2017-06-01

Objective measures of frailty have not been well defined as risk factors for a poor outcome after transcatheter aortic valve insertion. We hypothesized that assisted care as a baseline patient characteristic was a simple objective measure of frailty. We reviewed our experience to assess for an association between assisted care and outcome of operation. We retrospectively reviewed the records of 597 patients operated with transcatheter aortic valve insertion from November 2008 through July 2015. The study cohort included patients with a dichotomous baseline characteristic of receiving assisted care (AC group, n = 60, 10.1%) or not receiving assisted care (NC group, n = 537, 89.9%). The endpoints of the study were operative stroke/death and 1-year survival. The age of the patients was 80.6 ± 9.0 years, male sex was present in 349 (58.5%), and STS predicted risk of mortality was 9.2 ± 6.2%. Alternate access was used in 26 (43.3%) patients in the AC care group and in 220 (41.0%) in the NC group (P = 0.724). Operative stroke/death occurred in 4 (6.7%) patients in the AC group and in 25 (4.7%) in the NC group (P = 0.492). Mortality at 1 year in the AC group was 14.8 ± 5.2% and in the NC group was 12.9 ± 1.7%; (P = 0. 250). Assisted care as a baseline patient characteristic does not result in increased operative stroke/death or 1-year mortality in patients following transcatheter aortic valve insertion. Assisted care should not by itself preclude operation. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Direct transcatheter aortic valve implantation with self-expandable bioprosthesis: feasibility and safety.

PubMed

Fiorina, Claudia; Maffeo, Diego; Curello, Salvatore; Lipartiti, Felicia; Chizzola, Giuliano; D'Aloia, Antonio; Adamo, Marianna; Mastropierro, Rosy; Gavazzi, Emanuele; Ciccarese, Camilla; Chiari, Ermanna; Ettori, Federica

2014-06-01

Balloon valvuloplasty has been considered a mandatory step of the transcatheter aortic valve implantation (TAVI), although it is not without risk. The aim of this work was to evaluate the feasibility and safety of TAVI performed without pre-dilation (direct TAVI) of the stenosed aortic valve. Between June 2012 and June 2013, 55 consecutive TAVI performed without pre-dilation at our institution using the self-expandable CoreValve prosthesis (Medtronic, Minneapolis, MN) were analyzed and compared with 45 pre-dilated TAVI performed the previous year. Inclusion criteria were a symptomatic and severe aortic stenosis. Exclusion criteria were defined as presence of pure aortic regurgitation, degenerated surgical bioprosthesis or bicuspid aortic valve and prior procedure of balloon aortic valvuloplasty performed as a bridge to TAVI. High-burden calcification in the device landing zone, assessed by CT scan, was found in most of the patients. The valve size implanted was similar in both groups. Device success was higher in direct TAVI (85%vs.64%,p=0.014), mostly driven by a significant lower incidence of paravalvular leak (PVL≥2;9%vs.33%,p=0.02). Safety combined end point at 30 days was similar in both groups. Compared to TAVI with pre-dilation, direct TAVI is feasible regardless of the presence of bulky calcified aortic valve and the valve size implanted. Device success was higher in direct TAVI, mostly driven by a lower incidence of paravalvular leak. Safety at 30 days was similar in two groups. Copyright © 2014 Elsevier Inc. All rights reserved.

Apical-access-related complications associated with trans-catheter aortic valve implantation.

PubMed

Bleiziffer, Sabine; Piazza, Nicolo; Mazzitelli, Domenico; Opitz, Anke; Bauernschmitt, Robert; Lange, Rüdiger

2011-08-01

The left-ventricular trans-apical access has become well established for trans-catheter aortic valve implantation, especially for patients in whom a retrograde trans-arterial implantation is contraindicated. We report on the short- and long-term implications of the apical-access-site-specific complications. Between June 2007 and August 2010, 143 patients were scheduled for trans-apical aortic valve implantation (mean age 80 ± 6 years, n=116 females, mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) 21 ± 13%). The patients are followed up at 30 days, 6 months, and then annually. Severe apical bleeding complications occurred in 10 patients (7%). In three of these patients, the procedure was terminated, and no valve was implanted. In the remaining, the bleeding was controlled with cardiopulmonary bypass support (n=3), via median sternotomy (n=1), or both (n=1) ± later re-exploration. Two additional patients required postprocedural re-exploration for apical bleeding. An apical pseudo-aneurysm developed in two patients (2%), one of whom was treated by surgical revision. Survival was significantly impaired when either apical bleeding, aneurysm, or re-exploration occurred (75% ± 0.082 survival at 30 days and 59% ± 0.122 at 1 year vs 94% ± 0.023 and 80% ± 0.043 in patients without apical complications, p=0.012). Twelve patients (8%) experienced secondary wound healing. An apical hypo- or akinesia was detected in 18/54 (33%) patients at 6 months' echocardiographic investigation, and in 11/30 (37%) 1 year after the procedure. The trans-apical access for trans-catheter aortic valve implantation might be challenging in elderly patients with fragile tissue. Severe bleeding complications or aneurysm formation significantly impairs survival. The clinical impact of subsequent apical hypo- or akinesia has to be further followed up. Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients.

PubMed

Leon, Martin B; Smith, Craig R; Mack, Michael J; Makkar, Raj R; Svensson, Lars G; Kodali, Susheel K; Thourani, Vinod H; Tuzcu, E Murat; Miller, D Craig; Herrmann, Howard C; Doshi, Darshan; Cohen, David J; Pichard, Augusto D; Kapadia, Samir; Dewey, Todd; Babaliaros, Vasilis; Szeto, Wilson Y; Williams, Mathew R; Kereiakes, Dean; Zajarias, Alan; Greason, Kevin L; Whisenant, Brian K; Hodson, Robert W; Moses, Jeffrey W; Trento, Alfredo; Brown, David L; Fearon, William F; Pibarot, Philippe; Hahn, Rebecca T; Jaber, Wael A; Anderson, William N; Alu, Maria C; Webb, John G

2016-04-28

Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients. We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral-access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation. In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

Prosthetic valve endocarditis 7 months after transcatheter aortic valve implantation diagnosed with 3D TEE.

PubMed

Sarı, Cenk; Durmaz, Tahir; Karaduman, Bilge Duran; Keleş, Telat; Bayram, Hüseyin; Baştuğ, Serdal; Özen, Mehmet Burak; Bayram, Nihal Akar; Bilen, Emine; Ayhan, Hüseyin; Kasapkara, Hacı Ahmet; Bozkurt, Engin

2016-01-01

Transcatheter aortic valve implantation (TAVI) was introduced as an alternative treatment for patients with severe symptomatic aortic stenosis for whom surgery would be high-risk. Prosthetic aortic valve endocarditis is a serious complication of surgical AVR (SAVR) with high morbidity and mortality. According to recent cases, post-TAVI prosthetic valve endocarditis (PVE) seems to occur very rarely. We present the case of a 75-year-old woman who underwent TAVI (Edwards Saphien XT) with an uneventful postoperative stay. She was diagnosed with endocarditis using three dimensional (3D) echocardiography on the TAVI device 7 months later and she subsequently underwent surgical aortic valve replacement. Little experience of the interpretation of transoesophageal echocardiography (TEE) and the clinical course and effectiveness of treatment strategies in post-TAVI endocarditis exists. We report a case of PVE in a TAVI patient which was diagnosed with three-dimensional transoesophageal echocardiography (3DTEE). Copyright © 2016 Hellenic Cardiological Society. Published by Elsevier B.V. All rights reserved.

Dual or Single Antiplatelet Therapy After Transcatheter Aortic Valve Implantation? A Systematic Review and Meta-Analysis.

PubMed

Vavuranakis, Manolis; Siasos, Gerasimos; Zografos, Theodoros; Oikonomou, Evangelos; Vrachatis, Dimitris; Kalogeras, Konstantinos; Papaioannou, Theodoros; Kolokathis, Michail-Aggelos; Moldovan, Carmen; Tousoulis, Dimitrios

2016-01-01

Transcatheter aortic valve implantation (TAVI) has undeniably earned a prestigious post in the quiver of interventional cardiologists against symptomatic severe aortic stenosis. Cerebrovascular events are listed within the most frequent complications. We performed a systematic search of EMBASE, MEDLINE, and the Cochrane library from inception to March 2016 for the following search terms (transcatheter AND antiplatelet) OR (transcatheter AND antithrombotic) to retrieve studies of dual antiplatelet treatment (DAPT) and single antiplatelet treatment (SAPT) in patients after TAVI to study thrombotic, hemorrhagic and cardiovascular events at 30 days post procedure. From a total of 208 records 4 studies met inclusion criteria. In the included studies, 286 patients were enrolled in the DAPT group and 354 patients in the SAPT group. There was no difference in all-cause mortality, cardiovascular mortality, stroke, and myocardial infraction 30 days post TAVI between DAPT and SAPT. However, patients in the DAPT group had a significantly increased incidence of lethal and major bleeding at 30 days of follow-up and the incidence of the combined end-point of stroke, spontaneous MI, all-cause mortality and major bleeding was significantly higher in the DAPT group in comparison to the SAPT group. DAPT compared to SAPT in patients after TAVI increases incidence of hemorrhagic events with no benefits in terms of thrombotic events and cardiovascular mortality. However, these data must be interpreted cautiously and the choice of DAPT over SAPT must be based on an individual patient characteristic according to medical practice criteria.

Does Undersizing of Transcatheter Aortic Valve Bioprostheses during Valve-in-Valve Implantation Avoid Coronary Obstruction? An In Vitro Study.

PubMed

Stock, Sina; Scharfschwerdt, Michael; Meyer-Saraei, Roza; Richardt, Doreen; Charitos, Efstratios I; Sievers, Hans-Hinrich; Hanke, Thorsten

2017-04-01

Background  The transcatheter aortic valve-in-valve implantation (TAViVI) is an evolving treatment strategy for degenerated surgical aortic valve bioprostheses (SAVBs) in patients with high operative risk. Although hemodynamics is excellent, there is some concern regarding coronary obstruction, especially in SAVB with externally mounted leaflet tissue, such as the Trifecta (St. Jude Medical Inc., St. Paul, Minnesota, United States). We investigated coronary flow and hydrodynamics before and after TAViVI in a SAVB with externally mounted leaflet tissue (St. Jude Medical, Trifecta) with an undersized transcatheter aortic valve bioprosthesis (Edwards Sapien XT; Edwards Lifesciences LLC, Irvine, California, United States) in an in vitro study. Materials and Methods  An aortic root model was constructed incorporating geometric dimensions known as risk factors for coronary obstruction. Investigating the validity of this model, we primarily performed recommended TAViVI with the Sapien XT (size 26 mm) in a Trifecta (size 25 mm) in a mock circulation. Thereafter, hydrodynamic performance and coronary flow (left/right coronary diastolic flow [lCF/rCF]) after TAViVI with an undersized Sapien XT (size 23 mm) in a Trifecta (size 25 mm) were investigated at two different coronary ostia heights (COHs, 8 and 10 mm). Results  Validation of the model led to significant coronary obstruction ( p  < 0.001). Undersized TAViVI showed no significant reduction with respect to coronary flow (lCF: COH 8 mm, 0.90-0.87 mL/stroke; COH 10 mm, 0.89-0.82 mL/stroke and rCF: COH 8 mm, 0.64-0.60 mL/stroke; COH 10 mm, 0.62-0.58 mL/stroke). Mean transvalvular gradients (4-5 mm Hg, p  < 0.001) increased significantly after TAViVI. Conclusions  In our in vitro model, undersized TAViVI with the balloon-expandable Sapien XT into a modern generation SAVB (Trifecta) successfully avoided coronary flow obstruction. Georg Thieme Verlag KG Stuttgart · New York.

Clinical efficacy of transcatheter aortic valve replacement for severe aortic stenosis in high-risk patients: the PREVAIL JAPAN trial.

PubMed

Sawa, Yoshiki; Takayama, Morimasa; Mitsudo, Kazuaki; Nanto, Shinsuke; Takanashi, Shuichiro; Komiya, Tatsuhiko; Kuratani, Toru; Tobaru, Tetsuya; Goto, Tsuyoshi

2015-01-01

Transcatheter aortic valve replacement (TAVR) is suggested to be less invasive and/or equally effective in comparison to conventional aortic valve replacement for high-risk symptomatic aortic stenosis patients. We herein report the initial results of a pivotal clinical trial of TAVR in Japan (the PREVAIL JAPAN). Sixty-four aortic stenosis patients (mean age 84.3 ± 6.1 years) not suitable for surgery were enrolled at three centers in Japan, with a primary composite endpoint of the 6-month post-procedure improvements in the aortic valve area and New York Heart Association (NYHA) functional classification. A transfemoral approach was used in 37 patients and a transapical approach was used in 27. The device success rate was 91.9 %. After 30 days and 6 months, the rates of mortality from any cause were 8.1 and 11.3 %, respectively. At 6 months, symptomatic stroke was found in 3.1 % of the patients, and silent infarction in 7.8 %. The aortic valve area and mean pressure gradient were significantly improved over time with both approaches (p < 0.001). At 6 months, the NYHA functional classification based on a conventional physician's assessment was improved in 87.9 % of the patients. We found results that were equivalent to those in other major TAVR trials, such as an acceptable 30-day survival (91.9 %), suggesting that balloon-expandable TAVR is effective for small Japanese AS patients classified as high-risk or inoperable.

Vortex dynamics in Patient-Specific Stenotic Tricuspid and Bicuspid Aortic Valves pre- and post- Trans-catheter Aortic Valve Replacement

NASA Astrophysics Data System (ADS)

Hatoum, Hoda; Dasi, Lakshmi Prasad

2017-11-01

Understanding blood flow related adverse complications such as leaflet thrombosis post-transcatheter aortic valve implantation (TAVI) requires a deeper understanding of how patient-specific anatomic and hemodynamic factors, and relative valve positioning dictate sinus vortex flow and stasis regions. High resolution time-resolved particle image velocimetry measurements were conducted in compliant and transparent 3D printed patient-specific models of stenotic bicuspid and tricuspid aortic valve roots from patients who underwent TAVI. Using Lagrangian particle tracking analysis of sinus vortex flows and probability distributions of residence time and blood damage indices we show that (a) patient specific modeling provides a more realistic assessment of TAVI flows, (b) TAVI deployment alters sinus flow patterns by significantly decreasing sinus velocity and vorticity, and (c) relative valve positioning can control critical vortex structures that may explain preferential leaflet thrombosis corresponding to separated flow recirculation, secondary to valve jet vectoring relative to the aorta axis. This work provides new methods and understanding of the spatio-temporal aortic sinus vortex dynamics in post TAVI pathology. This study was supported by the Ohio State University DHLRI Trifit Challenge award.

Impact of wait times on the effectiveness of transcatheter aortic valve replacement in severe aortic valve disease: a discrete event simulation model.

PubMed

Wijeysundera, Harindra C; Wong, William W L; Bennell, Maria C; Fremes, Stephen E; Radhakrishnan, Sam; Peterson, Mark; Ko, Dennis T

2014-10-01

There is increasing demand for transcatheter aortic valve replacement (TAVR) as the primary treatment option for patients with severe aortic stenosis who are high-risk surgical candidates or inoperable. We used mathematical simulation models to estimate the hypothetical effectiveness of TAVR with increasing wait times. We applied discrete event modelling, using data from the Placement of Aortic Transcatheter Valves (PARTNER) trials. We compared TAVR with medical therapy in the inoperable cohort, and compared TAVR to conventional aortic valve surgery in the high-risk cohort. One-year mortality and wait-time deaths were calculated in different scenarios by varying TAVR wait times from 10 days to 180 days, while maintaining a constant wait time for surgery at a mean of 15.6 days. In the inoperable cohort, the 1-year mortality for medical therapy was 50%. When the TAVR wait time was 10 days, the TAVR wait-time mortality was 1.9% with a 1-year mortality of 31.5%. TAVR wait-time deaths increased to 28.9% with a 180-day wait, with a 1-year mortality of 41.4%. In the high-risk cohort, the wait-time deaths and 1-year mortality for the surgical patients were 2.5% and 27%, respectively. The TAVR wait-time deaths increased from 2.2% with a 10-day wait to 22.4% with a 180-day wait, and a corresponding increase in 1-year mortality from 24.5% to 32.6%. Mortality with TAVR exceeded surgery when TAVR wait times exceeded 60 days. Modest increases in TAVR wait times have a substantial effect on the effectiveness of TAVR in inoperable patients and high-risk surgical candidates. Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Update of transcatheter valve treatment

PubMed Central

Liu, Xian-bao; Wang, Jian-an

2013-01-01

Transcatheter valve implantation or repair has been a very promising approach for the treatment of valvular heart diseases since transcatheter aortic valve implantation (TAVI) was successfully performed in 2002. Great achievements have been made in this field (especially TAVI and transcatheter mitral valve repair—MitraClip system) in recent years. Evidence from clinical trials or registry studies has proved that transcatheter valve treatment for valvular heart diseases is safe and effective in surgical high-risk or inoperable patients. As the evidence accumulates, transcatheter valve treatment might be an alterative surgery for younger patients with surgically low or intermediate risk valvular heart diseases in the near future. In this paper, the updates on transcatheter valve treatment are reviewed. PMID:23897785

Management of significant left main coronary disease before and after trans-apical transcatheter aortic valve replacement in a patient with severe and complex arterial disease.

PubMed

Paradis, Jean-Michel; George, Isaac; Kodali, Susheel

2013-09-01

We report the case of an 81-year-old woman with symptomatic severe aortic stenosis, extremely significant peripheral arterial disease, and obstructive coronary artery disease who underwent percutaneous coronary intervention via a transaxillary conduit immediately before a trans-apical transcatheter aortic valve replacement performed with a transfemoral device. After deployment of the transcatheter heart valve, there was a left main coronary obstruction and the patient required an emergent PCI. This multifaceted case clearly underlines the importance of a well functioning heart team including the interventional cardiologist, the cardiovascular surgeon, and the echocardiographer. Copyright © 2013 Wiley Periodicals, Inc.

Impact of different aortic valve calcification patterns on the outcome of transcatheter aortic valve implantation: A finite element study.

PubMed

Sturla, Francesco; Ronzoni, Mattia; Vitali, Mattia; Dimasi, Annalisa; Vismara, Riccardo; Preston-Maher, Georgia; Burriesci, Gaetano; Votta, Emiliano; Redaelli, Alberto

2016-08-16

Transcatheter aortic valve implantation (TAVI) can treat symptomatic patients with calcific aortic stenosis. However, the severity and distribution of the calcification of valve leaflets can impair the TAVI efficacy. Here we tackle this issue from a biomechanical standpoint, by finite element simulation of a widely adopted balloon-expandable TAVI in three models representing the aortic root with different scenarios of calcific aortic stenosis. We developed a modeling approach realistically accounting for aortic root pressurization and complex anatomy, detailed calcification patterns, and for the actual stent deployment through balloon-expansion. Numerical results highlighted the dependency on the specific calcification pattern of the "dog-boning" of the stent. Also, local stent distortions were associated with leaflet calcifications, and led to localized gaps between the TAVI stent and the aortic tissues, with potential implications in terms of paravalvular leakage. High stresses were found on calcium deposits, which may be a risk factor for stroke; their magnitude and the extent of the affected regions substantially increased for the case of an "arc-shaped" calcification, running from commissure to commissure. Moreover, high stresses due to the interaction between the aortic wall and the leaflet calcifications were computed in the annular region, suggesting an increased risk for annular damage. Our analyses suggest a relation between the alteration of the stresses in the native anatomical components and prosthetic implant with the presence and distribution of relevant calcifications. This alteration is dependent on the patient-specific features of the calcific aortic stenosis and may be a relevant indicator of suboptimal TAVI results. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Cardiovascular Collapse During Transcatheter Aortic Valve Replacement: Diagnosis and Treatment of the “Perilous Pentad”

PubMed Central

El-Gamel, Adam

2013-01-01

Transcatheter aortic valve replacement (TAVR) has, without a doubt, brought an unprecedented excitement to the field of interventional cardiology. The avoidance of a sternotomy by transfemoral or transapical aortic-valve implantation appears to come at the price of some serious complications, including an increased risk of embolic stroke and paravalvular leakage. The technical challenges of the procedure and the complex nature of the high-risk patient cohort make the learning curve for this procedure a steep one, with the potential for unexpected complications always looming. Although most commonly relating to vascular access, these complications can also result from prosthesis-related trauma or malposition, or from unanticipated trauma from the pacing wire or the super stiff wire. Sudden and unexplained hypotension is often the earliest indicator of major complication and must prompt an immediate and detailed exclusion of five major pathologies: retroperitoneal bleeding from access site rupture, aortic dissection or rupture, pericardial tamponade, coronary ostial obstruction, or acute severe aortic regurgitation. In most cases, these can be dealt with quickly, and by percutaneous means, although open surgery may occasionally be necessary. Increased operator and team experience should make prevention and recognition of these catastrophic complications more complete. For this reason, the importance of specific training, such as that provided by the valve manufacturers through workshops and proctorship, cannot be overemphasized. It is essential that all operators, and indeed all members of the implant team, exert extreme vigilance to the development of intraprocedural complications, which could have rapid and potentially lethal consequences. Greater experience with an improved understanding of these risks, along with the development of better devices, deliverable through smaller and less traumatic sheath technology, will undoubtedly improve the safety and

Clinical Outcomes Following Transcatheter Aortic Valve Replacement in Asian Population.

PubMed

Yoon, Sung-Han; Ahn, Jung-Min; Hayashida, Kentaro; Watanabe, Yusuke; Shirai, Shinichi; Kao, Hsien-Li; Yin, Wei-Hsian; Lee, Michael Kang-Yin; Tay, Edgar; Araki, Motoharu; Yamanaka, Futoshi; Arai, Takahide; Lin, Mao-Shin; Park, Jun-Bean; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Lee, Cheol Whan; Park, Seong-Wook; Muramatsu, Toshiya; Hanyu, Michiya; Kozuma, Ken; Kim, Hyo-Soo; Saito, Shigeru; Park, Seung-Jung

2016-05-09

This study describes the characteristics of a real-world Asian patient population treated with transcatheter aortic valve replacement (TAVR) and evaluates their clinical outcomes. No previously reported randomized or observational studies adequately assess the safety and efficacy of TAVR in an Asian population. The Asian TAVR registry is an international multicenter study that enrolled patients with aortic stenosis who underwent TAVR in Asian countries. In total, 848 patients with mean STS score of 5.2 ± 3.8% were enrolled between March 2010 and September 2014 at 11 centers in 5 countries. The Edwards Sapien or Medtronic CoreValve was implanted in 64.7% and 35.3% of patients, respectively. The procedural success rate was 97.5%. The 30-day and 1-year mortality rates were 2.5% and 10.8%, respectively. There was no difference in 1-year mortality between devices (Sapien: 9.4%; CoreValve: 12.2%; log-rank p = 0.40). The rates of stroke, life-threatening bleeding, major vascular complications and acute kidney injury (stage 2 to 3) were 3.8%, 6.4%, 5.0% and 3.3%, respectively. Moderate or severe paravalvular leakage was significantly more common with the CoreValve than Sapien (14.4% vs. 7.3%; p = 0.001). According to the multivariate model, a higher STS score, lower body mass index, New York Heart Association functional class III-IV symptoms, diabetes mellitus, prior cerebrovascular accident, low mean gradient at baseline, and moderate or severe paravalvular leakage were significantly associated with reduced survival. Despite anatomical features of concern, the clinical outcomes of TAVR in our Asian population were favorable in comparison with those of previously published trials and observational studies. (The Asian Transcatheter Aortic Valve Replacement Registry [Asian TAVR]; NCT02308150). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Regional Systems of Care to Optimize Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement.

PubMed

Stub, Dion; Lauck, Sandra; Lee, May; Gao, Min; Humphries, Karin; Chan, Albert; Cheung, Anson; Cook, Richard; Della Siega, Anthony; Leipsic, Jonathon; Charania, Jay; Dvir, Danny; Latham, Tim; Polderman, Jopie; Robinson, Simon; Wong, Daniel; Thompson, Christopher R; Wood, David; Ye, Jian; Webb, John

2015-12-28

This study sought to describe the development of a multicenter, transcatheter aortic valve replacement program and regional systems of care intended to optimize coordinated, efficient, and appropriate delivery of this new therapy. Transcatheter aortic valve replacement (TAVR) has become an accepted treatment option for patients with severe aortic stenosis who are at high surgical risk. Regional systems of care have led to improvements in outcomes for patients undergoing intervention for myocardial infarction, cardiac arrest, and stroke. We implemented a regional system of care for patients undergoing TAVR in British Columbia, Canada. We describe a prospective observational cohort of 583 patients who underwent TAVR in British Columbia between 2012 and 2014. Regionalization of TAVR care in British Columbia refers to a centrally coordinated, funded, and evaluated program led by a medical director and a multidisciplinary advisory group that oversees planning, access to care, and quality of outcomes at the 4 provincial sites. Risk-stratified case selection for transfemoral TAVR is performed by heart teams at each site on the basis of consensus provincial indications. Referrals for lower volume and more complicated TAVR, including nontransfemoral access and valve-in-valve procedures, are concentrated at a single site. In-hospital and 30-day outcomes are reported. The median age was 83 years (interquartile range [IQR]: 78 to 87 years) and median STS score was 6% (IQR: 4% to 8%). Transfemoral access was performed in 499 (85.6%) cases and nontransfemoral in 84 (14.4%). Transcatheter valve-in-valve procedures in for failed bioprosthetic valves were performed in 43 patients (7.4%). A balloon-expandable valve was inserted in 386 (66.2%) and a self-expanding valve in 189 (32.4%). All-cause 30-day mortality was 3.5%. All-cause in-hospital mortality and disabling stroke occurred in 3.1% and 1.9%, respectively. Median length of stay was 3 days (IQR: 3 to 6 days), with 92.8% of

Redo aortic valve surgery versus transcatheter valve-in-valve implantation for failing surgical bioprosthetic valves: consecutive patients in a single-center setting

PubMed Central

Wottke, Michael; Deutsch, Marcus-André; Krane, Markus; Piazza, Nicolo; Lange, Ruediger; Bleiziffer, Sabine

2015-01-01

Background Due to a considerable rise in bioprosthetic as opposed to mechanical valve implantations, an increase of patients presenting with failing bioprosthetic surgical valves in need of a reoperation is to be expected. Redo surgery may pose a high-risk procedure. Transcatheter aortic valve-in-valve implantation is an innovative, less-invasive treatment alternative for these patients. However, a comprehensive evaluation of the outcome of consecutive patients after a valve-in-valve TAVI [transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV)] as compared to a standard reoperation [surgical aortic valve redo-operation (SAV-in-SAV)] has not yet been performed. The goal of this study was to compare postoperative outcomes after TAV-in-SAV and SAV-in-SAV in a single center setting. Methods All SAV-in-SAV and TAV-in-SAV patients from January 2001 to October 2014 were retrospectively reviewed. Patients with previous mechanical or transcatheter valves, active endocarditis and concomitant cardiac procedures were excluded. Patient characteristics, preoperative data, post-procedural complications, and 30-day mortality were collected from a designated database. Mean values ± SD were calculated for all continuous variables. Counts and percentages were calculated for categorical variables. The Chi-square and Fisher exact tests were used to compare categorical variables. Continuous variables were compared using the t-test for independent samples. A 2-sided P value <0.05 was considered statistically significant. Results A total of 102 patients fulfilled the inclusion criteria, 50 patients (49%) underwent a transcatheter valve-in-valve procedure, while 52 patients (51%) underwent redo-surgery. Patients in the TAV-in-SAV group were significantly older, had a higher mean logistic EuroSCORE and exhibited a lower mean left ventricular ejection fraction than patients in the SAV-in-SAV group (78.1±6.7 vs. 66.2±13.1, P<0.001; 27.4±18.7 vs. 14.4±10, P<0.001; and 49.8±13

Transcatheter aortic valve replacement: historical perspectives, current evidence, and future directions.

PubMed

Horne, Aaron; Reineck, Elizabeth A; Hasan, Rani K; Resar, Jon R; Chacko, Matthews

2014-10-01

Severe aortic stenosis (AS) results in considerable morbidity and mortality without aortic valve replacement and is expected to increase in prevalence with the aging population. Because AS primarily affects the elderly, many patients with comorbidities are poor candidates for surgical aortic valve replacement (SAVR) and may not be referred. Transcatheter aortic valve replacement (TAVR) has emerged as transformative technology for the management of AS over the past decade. Randomized trials have established the safety and efficacy of TAVR with improved mortality and quality of life compared with medical therapy in inoperable patients, while demonstrating noninferiority and even superiority to SAVR among high-risk operative candidates. However, early studies demonstrated an early penalty of stroke and vascular complications with TAVR as well as increased paravalvular leak as compared with SAVR. Two device platforms have been evaluated and approved for use in the United States: the Edwards SAPIEN and the Medtronic CoreValve. Early studies also suggest cost-effectiveness for TAVR. Ongoing studies are evaluating new iterations of the aforementioned TAVR devices, novel device designs, and applications of TAVR in expanded populations of patients including those with lower risk profiles as well as those with comorbidities that were excluded from early clinical trials. Future improvements in TAVR technology will likely reduce periprocedural and long-term complications. Further studies are needed to confirm device durability over long-term follow-up and explore the applicability of TAVR to broader AS patient populations. Copyright © 2014 Mosby, Inc. All rights reserved.

Implementation of transcatheter aortic valve replacement in California: Influence on aortic valve surgery.

PubMed

Maximus, Steven; Milliken, Jeffrey C; Danielsen, Beate; Shemin, Richard; Khan, Junaid; Carey, Joseph S

2018-04-01

Transcatheter aortic valve replacement (TAVR) procedures were introduced in 2011. Initially, procedures were limited to patients who were not surgical candidates, but subsequently high-risk surgical candidates were considered for TAVR. The influence on aortic valve surgery in California is unknown. The California Office of Statewide Health Planning and Development hospitalized patient discharge database was queried for the years 2009 through 2014. isolated surgical aortic valve and aortic valve/coronary artery bypass graft (SAVR) and TAVR procedures were identified by International Classification of Diseases-9th revision clinical modification procedure codes. Seven TAVR programs were introduced in 2011, 12 in 2012, 3 in 2013, and 6 in 2014. SAVR procedure volumes were compared from the 2 years before institution with SAVR volumes during the year(s) after institution of the TAVR program in these 28 hospitals. Overall, surgical volumes increased during the first, second, and third years after implementation of TAVR procedures. Among 7 hospitals with 4-year programs, surgical volumes increased to a maximum of 15.5% during the third year, then began to decrease. The hospital performing the largest number of TAVR procedures showed a marked decrease in SAVR volume by the fourth year, suggesting a shift of SAVR candidates to TAVR. Among all hospitals with 4-year programs, TAVR exceeded SAVR procedures by the fourth year. In California overall, SAVR increased during 2011 through 2013, due primarily to increasing volume of isolated SAVR procedures. Statewide, isolated SAVR increased from a yearly average of 3111 procedures during 2009-2010 to 3592 (+15.5%) in 2013, then decreased slightly in 2014. SAVR plus coronary artery bypass graft procedures decreased during the same time period. After implementation of TAVR, hospital SAVR volumes increased moderately, then began to decrease by the fourth year, when TAVR volume exceeded SAVR. Surgical candidates may be identified

Concurrent Transcatheter Aortic Valve Implantation and Percutaneous Transvenous Mitral Commissurotomy for Totally Percutaneous Treatment of Combined Severe Rheumatic Aortic and Mitral Stenosis.

PubMed

Bilge, Mehmet; Alsancak, Yakup; Ali, Sina; Yasar, Ayse Saatci

2015-05-01

Transcatheter aortic valve implantation (TAVI) is a new promising therapeutic option for patients with symptomatic severe calcific aortic valve stenosis (AS) who are inoperable or at high risk for conventional cardiac surgery. Percutaneous transvenous mitral commissurotomy (PTMC) is performed routinely in patients with severe mitral stenosis (MS) having a favorable anatomy. Although concurrent TAVI and PTMC is a theoretically possible approach in the treatment of patients with severe AS and MS who are unsuitable for conventional surgery, no cases have yet been reported in which this combined technique is used. For patients with severe AS and MS, the standard therapy is replacement of both the mitral and aortic valves. Herein are presented the details of a 52-year-old woman with urethral carcinoma, in whom simultaneous TAVI and PTMC was the chosen technique to treat combined severe rheumatic AS and MS in a single procedure.

Transcatheter aortic valve implantation. Expert Consensus of the Association of Cardiovascular Interventions of the Polish Cardiac Society and the Polish Society of Cardio-Thoracic Surgeons, approved by the Board of the Polish Cardiac Society….

PubMed

Parma, Radosław; Zembala, Michał O; Dąbrowski, Maciej; Jagielak, Dariusz; Witkowski, Adam; Suwalski, Piotr; Dudek, Dariusz; Olszówka, Piotr; Wojakowski, Wojciech; Przybylski, Roman; Gil, Robert; Kuśmierczyk, Mariusz; Lesiak, Maciej; Sadowski, Jerzy; Dobrzycki, Sławomir; Ochała, Andrzej; Hoffman, Piotr; Kapelak, Bogusław; Kaźmierczak, Jarosław; Jasiński, Marek; Stępińska, Janina; Szymański, Piotr; Hryniewiecki, Tomasz; Kochman, Janusz; Grygier, Marek; Zembala, Marian; Legutko, Jacek; Różański, Jacek

2017-01-01

Patients with severe symptomatic aortic stenosis have a poor prognosis with medical management alone, and surgical aortic valve replacement can improve symptoms and survival. In recent years, transcatheter aortic valve implantation (TAVI) has been demonstrated to improve survival in inoperable patients and to be an alternative treatment in patients in whom the risk of surgical morbidity or mortality is high or intermediate. A representative expert committee, summoned by the Association of Cardiovascular Interventions of the Polish Cardiac Society (ACVI) and the Polish Society of Cardio-Thoracic Surgeons, devel-oped this Consensus Statement in transcatheter aortic valve implantation. It endorses the important role of a multi-disciplinary "TAVI team" in selecting patients for TAVI and defines operator and institutional requirements fundamental to the establish-ment of a successful TAVI programme. The article summarises current evidence and provides specific recommendations on organisation and conduct of transcatheter treatment of patients with aortic valve disease in Poland.

Transcatheter aortic valve implantation of a second-generation valve for pure aortic regurgitation: procedural outcome, haemodynamic data and follow-up.

PubMed

Schlingloff, Friederike; Schäfer, Ulrich; Frerker, Christian; Schmoeckel, Michael; Bader, Ralf

2014-09-01

The second-generation Jenavalve prosthesis (Jenavalve Technology, Inc., Munich, Germany) is the first transcatheter valve Conformité Européene (CE) marked for treatment of both aortic stenosis (AS) and pure aortic regurgitation (AR). Although the feasibility of the Jenavalve transcatheter aortic valve implantation (TAVI) in patients with pure AR has been described, haemodynamic and follow-up data are lacking. We report on a series of 10 transapical Jenavalve implantations for pure AR between December 2012 and September 2013. The patients were determined for TAVI by heart team decision at high surgical risk [log EuroSCORE (European System for Cardiac Operative Risk Evaluation) >20%], frailty or Charlson Comorbidity Index (CCI). Transaortic gradients and right heart haemodynamics were measured invasively before and after TAVI. Ventriculography and transoesophageal echocardiography were used to determine paravalvular regurgitation. All-cause mortality, NYHA functional class and echocardiographic measurements were followed up at 30 days and at 3, 9 and 12 months postoperatively. Overall, mean age was 79 ± 9 years, mean left ventricular ejection fraction 50 ± 17% and mean log EuroSCORE 28.3 ± 17.1%. There were no perioperative complications. Paravalvular regurgitation immediately after implantation was graded none (n = 6), trace (n = 3) or mild (n = 1). Overall 30-day mortality was 30% (3/10). Three patients refused further treatment, such as haemodialysis or treatment of mitral regurgitation. Rate for pacemaker implantation was 2/10 (20%). Intraprocedural success and haemodynamic data in our cases were good. The mortality in our group highlighted the importance of careful patient selection, especially for this pathology. The Jenavalve prosthesis proved to be suitable for treatment of AR in surgical high-risk patients. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Successful non-surgical treatment of endocarditis caused by Staphylococcus haemolyticus following transcatheter aortic valve implantation (TAVI).

PubMed

Loverix, L; Timmermans, P; Benit, E

2013-01-01

We describe a case of a 79-year-old male patient with severe aortic stenosis who underwent transcatheter aortic valve implantation (TAVI) at our institution. He presented at the emergency department with dyspnea and fatigue 7 months after implantation. The diagnosis of early prosthetic valve endocarditis (PVE) caused by Staphylococcus haemolyticus was made by transesophageal echocardiography (TEE) and multiple positive blood cultures. Since our patient was considered inoperable due to a history of coronary artery bypass graft (CABG) surgery with patent bypasses, high peri-operative mortality including renal failure and a poor general prognosis, surgical removal of the valve was not an option. The patient was successfully treated with antibiotic therapy.

Repeat transcatheter aortic valve implantation using a latest generation balloon-expandable device for treatment of failing transcatheter heart valves.

PubMed

Schaefer, Andreas; Treede, Hendrik; Seiffert, Moritz; Deuschl, Florian; Schofer, Niklas; Schneeberger, Yvonne; Blankenberg, Stefan; Reichenspurner, Hermann; Schaefer, Ulrich; Conradi, Lenard

2016-01-15

Paravalvular leakage (PVL) is a known complication of transcatheter aortic valve implantation (TAVI) and is associated with poor outcome. Besides balloon-post-dilatation, valve-in-valve (ViV) procedures can be taken into consideration to control this complication. Herein we present initial experience with use of the latest generation balloon-expandable Edwards Sapien 3® (S3) transcatheter heart valve (THV) for treatment of failing THVs. Between 01/2014 and 12/2014 three patients (two male, age: 71-80 y, log EUROScore I: 11.89 - 32.63) with failing THVs were refered to our institution for further treatment. THV approach with secondary implantation of an S3 was chosen after mutual agreement of the local interdisciplinary heart team at an interval of 533-1119 days from the index procedure. The performed procedures consisted of: S3 in Sapien XT, JenaValve and CoreValve. Successful transfemoral implantation with significant reduction of PVL was achieved in all cases. No intraprocedural complications occurred regarding placement of the S3 with a postprocedural effective orifice area (EOA) of 1.5-2.5 cm(2) and pressure gradients of max/mean 14/6-36/16 mmHg. 30-day mortality was 0%. At the latest follow-up of 90-530 days, all patients are alive and well with satisfactory THV function. Regarding VARC-2 criteria one major bleeding and one TIA was reported. In the instance of moderate or severe aortic regurgitation after TAVI, S3 ViV deployment is an excellent option to reduce residual regurgitation to none or mild. For further assertions concerning functional outcomes long-term results have to be awaited.

Recent Advances in Transcatheter Aortic Valve Implantation: Novel Devices and Potential Shortcomings

PubMed Central

Blumenstein, J.; Liebetrau, C.; Linden, A. Van; Moellmann, H.; Walther, T.; Kempfert, J.

2013-01-01

During the past years transcatheter aortic valve implantation (TAVI) has evolved to a standard technique for the treatment of high risk patients suffering from severe aortic stenosis. Worldwide the number of TAVI procedures is increasing exponentially. In this context both the transapical antegrade (TA) and the transfemoral retrograde (TF) approach are predominantly used and can be considered as safe and reproducible access sites for TAVI interventions. As a new technology TAVI is in a constant progress regarding the development of new devices. While in the first years only the Edwards SAPIEN™ and the Medtronic CoreValve™ prostheses were commercial available, recently additional devices obtained CE-mark approval and others have entered initial clinical trials. In addition to enhance the treatment options in general, the main driving factor to further develop new device iterations is to solve the drawbacks of the current TAVI systems: paravalvular leaks, occurrence of AV-blocks and the lack of full repositionability. PMID:24313644

Cost-Effectiveness of Transcatheter Aortic Valve Replacement With a Self-Expanding Prosthesis Versus Surgical Aortic Valve Replacement

PubMed Central

Reynolds, Matthew R.; Lei, Yang; Wang, Kaijun; Chinnakondepalli, Khaja; Vilain, Katherine A.; Magnuson, Elizabeth A.; Galper, Benjamin Z.; Meduri, Christopher U.; Arnold, Suzanne V.; Baron, Suzanne J.; Reardon, Michael J.; Adams, David H.; Popma, Jeffrey J.; Cohen, David J.

2016-01-01

Background Prior studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system. Objectives The goal of this study was to evaluate the cost-effectiveness of TAVR with a self-expanding prosthesis compared with surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and high surgical risk. Methods We performed a formal economic analysis on the basis of individual, patient-level data from the CoreValve U.S. High Risk pivotal trial. Empirical data regarding survival and quality of life (QOL) over 2 years, and medical resource use and hospital costs through 12 months were used to project life expectancy, quality-adjusted life expectancy, and lifetime medical costs in order to estimate the incremental cost-effectiveness of TAVR versus SAVR from a U.S. perspective. Results Relative to SAVR, TAVR reduced initial length of stay an average of 4.4 days, decreased the need for rehabilitation services at discharge, and resulted in superior 1-month QOL. Index admission and projected lifetime costs were higher with TAVR than with SAVR (differences $11,260 and $17,849 per patient, respectively), whereas TAVR was projected to provide a lifetime gain of 0.32 quality-adjusted life-years (QALYs; 0.41 life-years [LYs]) with 3% discounting. Lifetime incremental cost-effectiveness ratios (ICERs) were $55,090 per QALY gained and $43,114 per LY gained. Sensitivity analyses indicated that a reduction in the initial cost of TAVR by ~$1,650 would lead to an ICER <$50,000/QALY gained. Conclusions In a high-risk clinical trial population, TAVR with a self-expanding prosthesis provided meaningful clinical benefits compared with SAVR, with incremental costs considered acceptable by current U.S. standards. With expected modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high. PMID:26764063

Trends in Aortic Valve Replacement Procedures Between 2009 and 2015: Has Transcatheter Aortic Valve Replacement Made a Difference?

PubMed

Culler, Steven D; Cohen, David J; Brown, Phillip P; Kugelmass, Aaron D; Reynolds, Matthew R; Ambrose, Karen; Schlosser, Michael L; Simon, April W; Katz, Marc R

2018-04-01

This study reports trends in volume and adverse events associated with isolated aortic valve procedures performed in Medicare beneficiaries between 2009 and 2015. This retrospective study used the annual fiscal year Medicare Provider Analysis and Review file to identify all Medicare beneficiaries undergoing an isolated aortic valve procedure. Outcome measures included three mortality rates and nine in-hospital adverse events. The final study population consisted of 233,660 hospitalizations. During the study period, Medicare beneficiaries undergoing an aortic valve procedure increased from 22,076 to 49,362, for an average annual growth rate of 14.45%. Transcatheter aortic valve replacement (TAVR) procedures per 100,000 Medicare beneficiaries grew from 10.7 in 2012 to 41.1 in 2015. Overall, in-hospital mortality rates, cumulative 30-day mortality rates, and 90-day postdischarge mortality rates declined annually during the study period. However, the 90-day mortality rate for TAVR was nearly double the rate for the tissue surgical aortic valve replacement group. Nearly 68% of Medicare beneficiaries experienced at least one in-hospital adverse event during their index hospitalization. Medicare beneficiaries undergoing TAVR had the lowest observed adverse events rates among the aortic valve procedures in 2015. The total number of Medicare beneficiaries undergoing isolated aortic valve procedures increased from 47.5 to 88.9 per 100,000 Medicare beneficiaries during the study period. Aortic valve procedures increased significantly during this study period primarily due to the increase in TAVR, with clinical outcomes improving as well. Although long-term outcomes of TAVR are still under investigation, these results are promising. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Percutaneous management of vascular access in transfemoral transcatheter aortic valve implantation

PubMed Central

Dato, Ilaria; Burzotta, Francesco; Trani, Carlo; Crea, Filippo; Ussia, Gian Paolo

2014-01-01

Transcatheter aortic valve implantation (TAVI) using stent-based bioprostheses has recently emerged as a promising alternative to surgical valve replacement in selected patients. The main route for TAVI is retrograde access from the femoral artery using large sheaths (16-24 F). Vascular access complications are a clinically relevant issue in TAVI procedures since they are reported to occur in up to one fourth of patients and are strongly associated with adverse outcomes. In the present paper, we review the different types of vascular access site complications associated with transfemoral TAVI. Moreover, we discuss the possible optimal management strategies with particular attention to the relevance of early diagnosis and prompt treatment using endovascular techniques. PMID:25228962

Improvement in renal functions with transcatheter aortic valve implantation

PubMed Central

Keleş, Telat; Ayhan, Hüseyin; Durmaz, Tahir; Sarı, Cenk; Aslan, Abdullah Nabi; Erdoğan, Kemal Eşref; Kasapkara, Hacı Ahmet; Bilen, Emine; Bayram, Nihal Akar; Akçay, Murat; Bozkurt, Engin

2013-01-01

Background & Objectives In recent years, emerging transcatheter aortic valve implantation (TAVI) has become an alternative for surgery. However, with advanced age, several co-morbid factors together with contrast agent usage can cause deterioration in renal function and increase in the risk of acute kidney injury (AKI) with poor prognosis in patients with AKI. Therefore, many patients cannot benefit from this treatment. In this study, we aim to examine the effects of TAVI on renal functions. Methods and Results Seventy patients, mean age of 77.6 years, underwent TAVI between July 2011 and December 2012. Estimated glomerular filtration rate (eGFR) was calculated by using the Cockcroft and Gault Formula. Patients were monitored for 48 h for urine output. Stage 1 AKI, according to the VARC-2 AKIN system, developed in only five (7.1%) of the patients after the procedure. There was a statistically significant increase between the mean 1st month eGFRs before (68.2 vs. 61.0, P < 0.01) and after (68.2 vs. 63.6, P < 0.05) the TAVI in the cohort. After TAVI (48.5 mL/min, P < 0.01) and the 1st month (52.1 mL/min, P < 0.01), the eGFR of the 36 (51.4%) patients diagnosed with chronic kidney disease before the procedure showed a statistically significant increase in renal functions. The hospital mortality rate was higher in the group which developed AKI (P < 0.01). First month eGFR showed a more statistically significant increase than pre-TAVI eGFR (62.8 and 69.8, P < 0.05, respectively) in AKI developing patients and this difference - though statistically not significant - continued into the sixth month. Conclusions In this study, we showed that the treatment of aortic stenosis through TAVI allows improvement of renal functions, and that AKI rates will be lower with careful patient selection, proper pre-procedural hydration, and careful use of contrast agent. PMID:24454323

Transcatheter aortic valve-in-valve implantation for severe bioprosthetic stenosis after Bentall operation using a homograft in a patient with Behçet's disease.

PubMed

Joo, Hyung Joon; Hong, Soon Jun; Yu, Cheol Woong

2015-03-01

A 43-year-old man presented with severe aortic stenosis. Eight years previously, he had undergone primary surgical aortic valve replacement (AVR) for severe aortic regurgitation, but one year later developed cardiac arrest and complete atrioventricular block as a result of non-bacterial thrombotic endocarditis with severe valvular dehiscence. Following the diagnosis of prosthetic valve failure caused by Behçet's disease, the patient underwent a Bentall operation using 23 mm aortic homograft with permanent pacemaker implantation and coronary artery bypass grafting. Subsequently, he was stable with steroid administration and azathioprine for seven years after the second operation, but recently suffered from severe dyspnea and chest pain. Echocardiography revealed the development of severe aortic stenosis. A preprocedural evaluation demonstrated a porcelain aorta with severe calcification in the previous homograft valve on computed tomography, and critical stenosis at the ostium of the left circumflex artery on coronary angiography. After percutaneous coronary intervention for the ostium of the left circumflex artery, a transcatheter AVR was successfully performed using a 26 mm Edwards SAPIEN XT valve. The patient recovered without any complications after the procedure. This is the first report of a successful transcatheter aortic valve-in valve implantation for severe homograft aortic stenosis after a Bentall operation, using a homograft, in a patient with Behçet's disease.

Four-year durability of clinical and haemodynamic outcomes of transcatheter aortic valve implantation with the self-expanding CoreValve.

PubMed

Gulino, Simona; Barbanti, Marco; Deste, Wanda; Immè, Sebastiano; Aruta, Patrizia; Bottari, Vera; Benvenuto, Emanuele; Tamburino, Claudia; Di Landro, Alessio; Liberto, Daria; Santonoceto, Letizia; Sicuso, Rita; Di Stefano, Daniele; Todaro, Denise; Di Simone, Emanuela; Indelicato, Antonino; Giannazzo, Daniela; Sgroi, Carmelo; Tamburino, Corrado

2016-10-10

Long-term data on the durability of currently available transcatheter heart valves are limited. We sought to assess four-year clinical and echocardiographic outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis. Between June 2007 and February 2014, 450 consecutive patients with symptomatic severe aortic stenosis underwent TAVI in our institution. For the purposes of this study, we included only those patients undergoing successful TAVI with the CoreValve prosthesis who had a minimum follow-up of four years (n=125). Survival rates at one, two, three and four years were 83.2, 76.8, 73.6 and 66.3%, respectively. Aortic regurgitation was a common finding after the procedure, especially due to paravalvular regurgitation (PVR), which was observed in the majority of patients (71.5%), mostly mild (52.0%). Progression from mild acute PVR to moderate PVR at four-year follow-up was reported in three patients. No cases of severe PVR were observed. Prosthetic valve failure was reported in four patients (3.2%). Our study demonstrates that favourable outcomes after successful TAVI are associated with sustained clinical and functional cardiovascular benefits up to four-year follow-up. Signs of moderate prosthetic valve failure are present only in a small percentage of patients.

Ferumoxytol MRA for transcatheter aortic valve replacement planning with renal insufficiency.

PubMed

Kallianos, Kimberly; Henry, Travis S; Yeghiazarians, Yerem; Zimmet, Jeffrey; Shunk, Kendrick A; Tseng, Elaine E; Mahadevan, Vaikom; Hope, Michael D

2017-03-15

Computed tomography angiography (CTA) is the test of choice for pre-procedure imaging of transcatheter aortic valve replacement (TAVR) candidates. The iodinated contrast required, however, increases the risk of renal dysfunction in patients with pre-existing renal failure. Ferumoxytol is a magnetic resonance imaging (MRI) contrast agent that can be used with renal failure. Its long vascular resonance time allows gated MRA sequences that approach CTA in image quality. We present respiratory and cardiac gated MRA enabled by ferumoxytol that can be post-processed in an analogous fashion to CTA. Seven patients with renal failure presenting for TAVR were imaged with respiratory and cardiac gated MRA at 3T using ferumoxtyol for contrast. Aortic annulus, root and peripheral access dimensions were calculated in a fashion identical to that used for CTA. Of these, 6 patients underwent a TAVR procedure and 5 had intraoperative valve assessment with transesophageal echocardiograph (TEE) using standard clinical protocols that employed both two- and three-dimensional techniques. Good correlation between MRA aortic annulus measurements and those from TEE were shown in 5 patients with mean annulus area of 392.4mm 2 (290-470 range) versus 374.1mm 2 (285-440 range), with a pairwise correlation coefficient of 0.92, p=0.029. All patients received Sapien valve implants (one 20mm, three 23mm, and two 26mm valves). Access decisions were guided by MRA with no complications. Annulus sizing resulted in no greater than trace/mild aortic regurgitation in all patients. Ferumoxytol MRA is a safe alternative to CTA in patients with renal failure for pre-TAVR analysis of the aortic root and peripheral access. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

CT predictors of post-procedural aortic regurgitation in patients referred for transcatheter aortic valve implantation: an analysis of 105 patients.

PubMed

Marwan, Mohamed; Achenbach, Stephan; Ensminger, Stefan M; Pflederer, Tobias; Ropers, Dieter; Ludwig, Josef; Weyand, Michael; Daniel, Werner G; Arnold, Martin

2013-06-01

Cardiac computed tomography (CT) allows accurate and detailed analysis of the anatomy of the aortic root and valve, including quantification of calcium. We evaluated the correlation between different CT parameters and the degree of post-procedural aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) using the balloon-expandable Edwards Sapien prosthesis. Pre-intervention contrast-enhanced dual source CT data sets of 105 consecutive patients (48 males, mean age 81 ± 6 years, mean logEuroSCORE 34 ± 13%) with symptomatic severe aortic valve stenosis referred for TAVI using the Edwards Sapien prosthesis (Edwards lifesciences, Inc., CA, USA) were analysed. The degrees of aortic valve commissural calcification and annular calcification were visually assessed on a scale from 0 to 3. Furthermore, the degree of aortic valve calcification as quantified by the Agatston score, aortic annulus eccentricity, aortic diameter at the level of the sinus of valsalva and at the sinotubular junction were assessed. Early post-procedural AR was assessed using aortography. Significant AR was defined as angiographic AR of at least moderate degree (AR ≥ 2). Visual assessment of the degree of aortic annular calcification as well as the Agatston score of aortic valve calcium correlated weakly, yet significantly with the degree of post-procedural AR (r = 0.31 and 0.24, p = 0.001 and 0.013, respectively). Compared to patients with AR < 2, patients with AR ≥ 2 showed more severe calcification of the aortic annulus (mean visual scores 1.9 ± 0.6 vs. 1.5 ± 0.6, p = 0.003) as well as higher aortic valve Agatston scores (1,517 ± 861 vs. 1,062 ± 688, p = 0.005). Visual score for commissural calcification did not differ significantly between both groups (mean scores 2.4 ± 0.5 vs. 2.5 ± 0.5, respectively, p = 0.117). No significant correlation was observed between the degree of AR and commissural calcification, aortic annulus eccentricity index or aortic diameters

Transapical aortic valve implantation in Rouen: four years' experience with the Edwards transcatheter prosthesis.

PubMed

Litzler, Pierre-Yves; Borz, Bogdan; Smail, Hassiba; Baste, Jean-Marc; Nafeh-Bizet, Catherine; Gay, Arnaud; Tron, Christophe; Godin, Matthieu; Caudron, Jerome; Hauville, Camille; Dacher, Jean-Nicolas; Cribier, Alain; Eltchaninoff, Hélène; Bessou, Jean-Paul

2012-03-01

The first French transapical transcatheter aortic valve implantation (TAVI) was performed in July 2007 in our department. To report 4-year outcomes of transapical implantation with the Edwards transcatheter bioprosthesis. We prospectively evaluated consecutive patients who underwent transapical implantation with an Edwards transcatheter bioprosthesis between July 2007 and October 2011. Patients were not suitable for conventional surgery (due to severe comorbidities) or transfemoral implantation (due to poor femoral access). Among 61 patients (59.0% men), mean logistic EuroSCORE was 27.5 ± 14.9% and mean age was 81.0 ± 6.8 years. Successful valve implantation was achieved in 59/61 patients (96.7%) of patients. The other two patients required conversion to conventional surgery due to prosthesis embolization and died. Six additional patients died in the postoperative period. Causes of perioperative death were two septic shocks (one of peritonitis), two multi-organ failure, one ventricular fibrillation and one respiratory insufficiency. Intraprocedural stroke was not observed in any patient. The actuarial survival rates at 1, 2 and 4 years were 73.8%, 67.2% and 41.0%. During this 4-year period, four patients died of cardiovascular events, but no impairment of transprosthesis gradient was observed. Our series of 61 patients who underwent transapical implantation of the Edwards transcatheter bioprosthesis shows satisfactory results, similar to other reports, considering the high level of severity of patients referred for this method. Transapical access is a reliable alternative method for patients that cannot benefit from a transfemoral approach. Copyright © 2012. Published by Elsevier Masson SAS.

Outcome after transvascular transcatheter aortic valve implantation in 2016.

PubMed

Gaede, Luise; Blumenstein, Johannes; Liebetrau, Christoph; Dörr, Oliver; Kim, Won-Keun; Nef, Holger; Husser, Oliver; Elsässer, Albrecht; Hamm, Christian W; Möllmann, Helge

2018-02-21

We analysed the number of procedures, complications, and in-hospital mortality rates of all patients undergoing transvascular transcatheter aortic valve implantation (TV-TAVI) in comparison to isolated surgical aortic valve replacement (iSAVR) from 2014 to 2016 in Germany. All aortic valve procedures performed in Germany are mandatorily registered in a quality control program. More than 15 000 TV-TAVI procedures were performed in 2016 in Germany. Especially the number of post-procedural complications declined within the last few years, including new pacemaker implantations (2015: 12.6% vs. 2016: 11.4%, P = 0.002) and vascular complications (2015: 8.5% vs. 2016: 7.1%; P < 0.001). Thus, in 2016 the overall in-hospital mortality rate after TV-TAVI was 2.6%, which is for the first time numerically below that of iSAVR, which was 2.9% (P = 0.19). A stratified analysis according to the German aortic valve score shows a lower observed than expected in-hospital mortality rate for TV-TAVI (O/E 0.68). Additionally, the in-hospital mortality was significantly lower after TV-TAVI than after iSAVR in the very high- (11.3% vs. 23.6%; P < 0.001), in the high- (4.1% vs. 9.2%; P < 0.001), and in the intermediate-risk group (3.0% vs. 4.6%; P = 0.016) and was similar to that of iSAVR in low-risk patients (1.6% vs. 1.4%; P = 0.4). The overall in-hospital mortality after TV-TAVI was numerically lower than after iSAVR in 2016 for the first time. In the low risk group in-hospital mortality was similar, whereas in all other risk groups in-hospital mortality after TV-TAVI was significantly lower than after SAVR. This is likely to contribute to a redefinition of the standard of care in the future. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Cardiology

Transcatheter aortic valve replacement

MedlinePlus

... fully will restrict blood flow. This is called aortic stenosis. If there is also a leak, it is ... TAVR is used for people with severe aortic stenosis who aren't ... valve . In adults, aortic stenosis usually occurs due to calcium ...

Contemporary Costs Associated With Transcatheter Aortic Valve Replacement: A Propensity-Matched Cost Analysis.

PubMed

Ailawadi, Gorav; LaPar, Damien J; Speir, Alan M; Ghanta, Ravi K; Yarboro, Leora T; Crosby, Ivan K; Lim, D Scott; Quader, Mohammed A; Rich, Jeffrey B

2016-01-01

The Placement of Aortic Transcatheter Valve (PARTNER) trial suggested an economic advantage for transcatheter aortic valve replacement (TAVR) for high-risk patients. The purpose of this study was to evaluate the cost effectiveness of TAVR in the "real world" by comparing TAVR with surgical aortic valve replacement (SAVR) in intermediate-risk and high-risk patients. A multiinstitutional database of The Society of Thoracic Surgeons (STS) (2011 to 2013) linked with estimated cost data was evaluated for isolated TAVR and SAVR operations (n = 5,578). TAVR-treated patients (n = 340) were 1:1 propensity matched with SAVR-treated patients (n = 340). Patients undergoing SAVR were further stratified into intermediate-risk (SAVR-IR: predicted risk of mortality [PROM] 4% to 8%) and high-risk (SAVR-HR: PROM >8%) cohorts. Median STS PROM for TAVR was 6.32% compared with 6.30% for SAVR (SAVR-IR 4.6% and SAVR-HR 12.4%). A transfemoral TAVR approach was most common (61%). Mortality was higher for TAVR (10%) compared with SAVR (6%, p < 0.047), whereas the SAVR group accrued higher major morbidity (27% vs 14%, p < 0.001) and longer postoperative hospital duration (7 days vs 6 days, p < 0.001). Importantly, TAVR incurred twice the median total costs compared with SAVR ($69,921 vs $33,598, p < 0.001). The increased cost of TAVR was largely driven by the cost of the valve (all p < 0.001). Intermediate-risk patients undergoing SAVR demonstrated the most exaggerated cost savings versus TAVR. TAVR was associated with greater total costs and mortality compared with SAVR in intermediate-risk and high-risk patients while conferring lower major morbidity and improved resource use. Increased cost of TAVR appears largely related to the cost of the valve. Until the price of TAVR valves decreases, these data suggest that TAVR may not provide the most cost-effective strategy, particularly for intermediate-risk patients. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc

Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium†

PubMed Central

Leon, Martin B.; Piazza, Nicolo; Nikolsky, Eugenia; Blackstone, Eugene H.; Cutlip, Donald E.; Kappetein, Arie Pieter; Krucoff, Mitchell W.; Mack, Michael; Mehran, Roxana; Miller, Craig; Morel, Marie-angèle; Petersen, John; Popma, Jeffrey J.; Takkenberg, Johanna J.M.; Vahanian, Alec; van Es, Gerrit-Anne; Vranckx, Pascal; Webb, John G.; Windecker, Stephan; Serruys, Patrick W.

2011-01-01

Objectives To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health. Background Transcatheter aortic valve implantation may provide a worthwhile less invasive treatment in many patients with severe aortic stenosis and since its introduction to the medical community in 2002, there has been an explosive growth in procedures. The integration of TAVI into daily clinical practice should be guided by academic activities, which requires a harmonized and structured process for data collection, interpretation, and reporting during well-conducted clinical trials. Methods and results The Valve Academic Research Consortium established an independent collaboration between Academic Research organizations and specialty societies (cardiology and cardiac surgery) in the USA and Europe. Two meetings, in San Francisco, California (September 2009) and in Amsterdam, the Netherlands (December 2009), including key physician experts, and representatives from the US Food and Drug Administration (FDA) and device manufacturers, were focused on creating consistent endpoint definitions and consensus recommendations for implementation in TAVI clinical research programs. Important considerations in developing endpoint definitions included (i) respect for the historical legacy of surgical valve guidelines; (ii) identification of pathophysiological mechanisms associated with clinical events; (iii) emphasis on clinical relevance. Consensus criteria were developed for the following endpoints: mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, and prosthetic valve performance. Composite

Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI.

PubMed

Auffret, Vincent; Lefevre, Thierry; Van Belle, Eric; Eltchaninoff, Hélène; Iung, Bernard; Koning, René; Motreff, Pascal; Leprince, Pascal; Verhoye, Jean Philippe; Manigold, Thibaut; Souteyrand, Geraud; Boulmier, Dominique; Joly, Patrick; Pinaud, Frédéric; Himbert, Dominique; Collet, Jean Philippe; Rioufol, Gilles; Ghostine, Said; Bar, Olivier; Dibie, Alain; Champagnac, Didier; Leroux, Lionel; Collet, Frédéric; Teiger, Emmanuel; Darremont, Olivier; Folliguet, Thierry; Leclercq, Florence; Lhermusier, Thibault; Olhmann, Patrick; Huret, Bruno; Lorgis, Luc; Drogoul, Laurent; Bertrand, Bernard; Spaulding, Christian; Quilliet, Laurent; Cuisset, Thomas; Delomez, Maxence; Beygui, Farzin; Claudel, Jean-Philippe; Hepp, Alain; Jegou, Arnaud; Gommeaux, Antoine; Mirode, Anfani; Christiaens, Luc; Christophe, Charles; Cassat, Claude; Metz, Damien; Mangin, Lionel; Isaaz, Karl; Jacquemin, Laurent; Guyon, Philippe; Pouillot, Christophe; Makowski, Serge; Bataille, Vincent; Rodés-Cabau, Josep; Gilard, Martine; Le Breton, Hervé

2017-07-04

Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited. The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period. TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers. A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased. The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all

Transcatheter valve implantation can alter fluid flow fields in aortic sinuses and ascending aorta

NASA Astrophysics Data System (ADS)

Saikrishnan, Neelakantan; Yoganathan, Ajit

2012-11-01

Transcatheter aortic valves (TAVs) are valve replacements used to treat aortic stenosis. Currently, these have been used in elderly patients at high-risk for open-heart procedures. Since these devices are implanted under fluoroscopic guidance, the implantation position of the valve can vary with respect to the native aortic valve annulus. The current study characterizes the altered hemodynamics in the aortic sinus and ascending aorta under different implantation (high and low) and cardiac output (2.5 and 5.0 L/min) conditions. Two commonly used TAV designs are studied using 2-D Particle Image Velocimetry (PIV). 200 phase locked images are obtained at every 25ms in the cardiac cycle, and the resulting vector fields are ensemble averaged. High implantation of the TAV with respect to the annulus causes weaker sinus washout and weaker sinus vortex formation. Additionally, the longer TAV leaflets can also result in a weaker sinus vortex. The level of turbulent fluctuations in the ascending aorta did not appear to be affected by axial positioning of the valve, but varied with cardiac output. The results of this study indicates that TAV positioning is important to be considered clinically, since this can affect coronary perfusion and potential flow stagnation near the valve.

[LONG TERM FOLLOW-UP OF TRANSCATHETER SELF EXPANDABLE AORTIC VALVE IMPLANTATION].

PubMed

Chen, Shmuel; Zenios, Vicky; Gilon, Dan; Planer, David; Beeri, Ronen; Lotan, Chaim; Danenberg, Haim D

2018-03-01

Aortic stenosis is the most common significant valvular disease in the western world. These patients are treated operatively unless they are at high operative risk or inoperable. During the last decade an alternative approach has evolved - transcatheter aortic valve implantation (TAVI). This method was shown to be at least as effective and safe as the operative one. However, very little data exists on long term follow-up (5 years and above), especially regarding valve durability and patient survival. To present a long term follow-up on patients who underwent transcutaneous self-expandable aortic valve implantation in our department between the years 2008-2011. In September 2008 the first CoreValve implantation was performed in Israel at Hadassah Medical Center. All records of patients who were transplanted between 9.2008 and 10.2011 were reviewed. The function of the valve early after the procedure was compared to its function at the end of the follow-up period. A total of 38 patients (out of 71) survived at least 54 months, of them, 19 have an echocardiography examination at the end of the follow-up period. In all patients the implanted valve was found to function well at the end of the follow-up period, without significant stenosis or paravalvular leak. In fact, in approximately half of these patients, the degree of paravalvular leak decreased during the follow-up period. On long term (5 years) follow-up of patients who were implanted with the self-expandable aortic valve (CoreValve), no deterioration of the valve was observed. In fact, in approximately half of the patients, a decrease in the severity of the paravalvular leak was demonstrated.

Balloon aortic valvuloplasty to improve candidacy of patients evaluated for transcatheter aortic valve replacement.

PubMed

Arsalan, Mani; Khan, Samir; Golman, Jake; Szerlip, Molly; Mahoney, Cecile; Herbert, Morley; Brown, David; Mack, Michael; Holper, Elizabeth M

2018-02-01

Evaluate the role of balloon aortic valvuloplasty (BAV) in improving candidacy of patients for transcatheter aortic valve replacement (TAVR). Patients who are not candidates for TAVR may undergo BAV to improve functional and clinical status. 117 inoperable or high-risk patients with critical aortic stenosis underwent BAV as a bridge-to-decision for TAVR. Frailty measures including gait speed, serum albumin, hand grip, activities of daily living (ADL); and NYHA functional class before and after BAV were compared. Mean age was 81.6 ± 8.5 years and the mean Society of Thoracic Surgeons predicted risk of mortality was 9.57 ± 5.51, with 19/117 (16.2%) patients non-ambulatory. There was no significant change in mean GS post-BAV, but all non-ambulatory patients completed GS testing at follow-up. Albumin and hand grip did not change after BAV, but there was a significant improvement in mean ADL score (4.85 ± 1.41 baseline to 5.20 ± 1.17, P = 0.021). The number of patients with Class IV congestive heart failure (CHF) was significantly lower post BAV (71/117 [60.7%] baseline versus 18/117 [15.4%], P = 0.008). 78/117 (66.7%) of patients were referred to definitive valve therapy after BAV. When evaluating frailty measures post BAV, we saw no significant improvement in mean GS, however, we observed a significant improvement in non-ambulatory patients and ADL scores. We also describe improved Class IV CHF symptoms. With this improved health status, the majority of patients underwent subsequent valve therapy, demonstrating that BAV may improve candidacy of patients for TAVR. © 2017, Wiley Periodicals, Inc.

The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis.

PubMed

Silaschi, Miriam; Treede, Hendrik; Rastan, Ardawan J; Baumbach, Hardy; Beyersdorf, Friedhelm; Kappert, Utz; Eichinger, Walter; Rüter, Florian; de Kroon, Thomas L; Lange, Rüdiger; Ensminger, Stephan; Wendler, Olaf

2016-11-01

Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with aortic stenosis (AS) at high surgical risk. The JenaValve™ is a second-generation, self-expanding transcatheter heart valve (THV), implanted through transapical access (TA). During stent deployment, a specific 'clipping-mechanism' engages native aortic valve cusps for fixation. We present 1-year outcomes of the JUPITER registry, a post-market registry of the JenaValve for TA-TAVR. The JUPITER registry is a prospective, multicentre, uncontrolled and observational European study to evaluate the long-term safety and effectiveness of the Conformité Européenne-marked JenaValve THV. A total of 180 patients with AS were enrolled between 2012 and 2014. End-points were adjudicated in accordance with the valve academic research consortium document no. 1 definitions. The mean age was 80.4 ± 5.9 years and the mean logistic European system for cardiac operative risk evaluation I 21.2 ± 14.7%. The procedure was successful in 95.0% (171/180), implantation of a second THV (valve-in-valve) was performed in 2.2% (4/180) and conversion to surgical aortic valve replacement (SAVR) was necessary in 2.8% (5/180). No annular rupture or coronary ostia obstruction occurred. Two patients required SAVR after the day of index procedure (1.1%). All-cause mortality at 30 days was 11.1% (20/180), being cardiovascular in 7.2% (13/180). A major stroke occurred in 1.1% (2/180) at 30 days, no additional major strokes were observed during 1 year. All-cause mortality after 30 days was 13.1% (21/160) and combined efficacy at 1 year was 80.8% (122/151). At 1-year follow-up, no patient presented with more than moderate paravalvular leakage, while 2 patients (3.2%) showed moderate, 12 (19.0%) mild and 49 (82.4%) trace/none paravalvular regurgitation. In a high-risk cohort of patients undergoing TA-TAVR for AS, the use of the JenaValve THV is safe and effective. In patients at higher risk for coronary ostia

Assessment of cardiovascular function following transcatheter aortic valve implantation based on six-minute walk test.

PubMed

Chodór, Piotr; Wilczek, Krzysztof; Zielińska, Teresa; Przybylski, Roman; Głowacki, Jan; Włoch, Łukasz; Zembala, Marian; Kalarus, Zbigniew

2017-01-01

Transcatheter aortic valve implantation (TAVI) is presently a recognized treatment mo-dality for patients with severe aortic stenosis ineligible for surgery. It reduces mortality as compared to the conservative treatment. It is further expected from this therapy to improve quality of life by improving of the cardiovascular function performance. The aim of this study is to compare patients' cardiovascular system efficiency in the 6-minute walk test (6MWT) made before and after TAVI and at the 6-12-month follow-up. From January 2009 until February 2012, in the Silesian Center for Heart Diseases in Zabrze, TAVI was performed in 104 patients. Eighty-two patients who underwent 6MWT before surgery were qualified for the analysis. The average age of the patients was 76.0 ± 9.17 years, women made 45.1%. The risk of surgical treatment according to the Logistic Euroscore averaged 22.76 ± 12.63%, and by the Society of Thoracic Surgeons - 5.55 ± 3.34%. The 6MWT was performed within 1 month before the TAVI procedure, up to a month after the procedure and during the 6-12-month follow-up. The 6-minute walk test after TAVI was performed by 64 patients, and after 6-12 month follow-up by 46 patients. The average distance in 6MWT increased from 268.4 ± 89.0 m before treat-ment to 290.0 ± 98.2 m after the procedure (p = 0.008) and 276.1 ± 93.5 m to 343.1 ± 96.7 m after 6-12 months (p < 0.0001). Transcatheter aortic valve implantation procedures significantly improve function of the cardiovascular system evaluated by the 6MWT in 1- and 6-12-month observations. (Cardiol J 2017; 24, 2: 167-175).

Early Outcomes for Valve-in-valve Transcatheter Aortic Valve Replacement in Degenerative Freestyle Bioprostheses.

PubMed

Sang, Stephane Leung Wai; Beute, Tyler; Heiser, John; Berkompas, Duane; Fanning, Justin; Merhi, William

2017-11-20

Transcatheter aortic valve replacement (TAVR) is used increasingly to treat bioprosthetic valve failure. A paucity of data exists regarding valve-in-valve (ViV) TAVR in degenerated Freestyle stentless bioprostheses (FSBs). This study sought to evaluate the feasibility and short-term outcomes of ViV TAVR in previously placed FSB. From October 2014 to September 2016, 22 patients at a single institution underwent ViV TAVR with a self-expanding transcatheter valve for a failing FSB. Patient baseline characteristics and clinical outcomes data were collected retrospectively and entered into a dedicated database. The mean patient age was 74 ± 9years, and the mean Society of Thoracic Surgeons' Risk score was 9.0 ± 7.4%. Ten patients presented with acute heart failure requiring urgent intervention. The most common mode of failure of the FSB was regurgitation caused by a flail or malcoapting leaflet. Seventeen (77%) patients had a modified subcoronary implantation, 3 (14%) had a full root replacement, and 2 (9%) had a root inclusion. Device success using a self-expanding transcatheter valve was 95%, all via transfemoral approach. The mean implant depth was 7 ± 3 mm. Thirty-day survival was 100%. No patient had more than mild paravalvular regurgitation at 30days, and the permanent pacemaker rate was 9%. The mean hospital stay after intervention was 5 ± 2days. ViV TAVR using a self-expanding transcatheter valve is safe, feasible, and can be used successfully to treat a failed FSB. Procedural challenges suggest referral to valve centers of excellence. Copyright © 2017 Elsevier Inc. All rights reserved.

Quality of Life After Transcatheter Aortic Valve Replacement: Prospective Data From GARY (German Aortic Valve Registry).

PubMed

Lange, Rüdiger; Beckmann, Andreas; Neumann, Till; Krane, Markus; Deutsch, Marcus-André; Landwehr, Sandra; Kötting, Joachim; Welz, Armin; Zahn, Ralf; Cremer, Jochen; Figulla, Hans R; Schuler, Gerhard; Holzhey, David M; Funkat, Anne-Kathrin; Heusch, Gerd; Sack, Stefan; Pasic, Miralem; Meinertz, Thomas; Walther, Thomas; Kuck, Karl-Heinz; Beyersdorf, Friedhelm; Böhm, Michael; Möllmann, Helge; Hamm, Christian W; Mohr, Friedrich W

2016-12-26

This study sought to analyze health-related quality-of-life (HrQoL) outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) based on data from GARY (German Aortic Valve Registry). Typically, patients currently referred for and treated by TAVR are elderly with a concomitant variable spectrum of multiple comorbidities, disabilities, and limited life expectancy. Beyond mortality and morbidity, the assessment of HrQoL is of paramount importance not only to guide patient-centered clinical decision-making but also to judge this new treatment modality in this high-risk patient population. In 2011, 3,875 patients undergoing TAVR were included in the GARY registry. HrQoL was prospectively measured using the EuroQol 5 dimensions questionnaire self-complete version on paper at baseline and 1 year. Complete follow-up EuroQol 5 dimensions questionnaire evaluation was available for 2,288 patients (transvascular transcatheter aortic valve replacement [TAVR-TV]: n = 1,626 and transapical TAVR [TAVR-TA]: n = 662). In-hospital mortality was 5.9% (n = 229) and the 1-year mortality was 23% (n = 893). The baseline visual analog scale score for general health status was 52.6% for TAVR-TV and 55.8% for TAVR-TA and, in parallel to an improvement in New York Heart Association functional class, improved to 59.6% and 58.5% at 1 year, respectively (p < 0.001). Between baseline and 1 year, the number of patients reporting no complaints increased by 7.8% (TAVR-TV) and by 3.5% within the mobility dimension, and by 14.1% (TAVR-TV) and 9.2% within the usual activity dimension, whereas only moderate changes were found for the self-care, pain or discomfort, and anxiety or depression dimensions. In a multiple linear regression analysis several pre- and post-operative factors were predictive for less pronounced HrQoL benefits. TAVR treatment led to improvements in HrQoL, especially in terms of mobility and usual activities. The magnitude of improvements was higher in the

Transcatheter aortic valve replacement in patients with severe aortic stenosis who are at high risk for surgical complications: summary assessment of the California Technology Assessment Forum.

PubMed

Tice, Jeffrey A; Sellke, Frank W; Schaff, Hartzell V

2014-08-01

The California Technology Assessment Forum is dedicated to assessment and public reporting of syntheses of available data on medical technologies. In this assessment, transcatheter aortic valve replacement (TAVR) was evaluated for patients with severe aortic stenosis (AS) who are at high risk for complications. In this assessment, 5 criteria were used: Regulatory approval, sufficient scientific evidence to allow conclusions on effectiveness, evidence that the technology improves net health outcomes, evidence that the technology is as beneficial as established methods, and availability of the technology outside investigational settings. In this assessment, all 5 criteria were judged to have been met. The primary benefit of TAVR is the ability to treat AS in patients who would otherwise be ineligible for surgical aortic valve replacement. It may also be useful for patients at high surgical risk by potentially reducing periprocedural complications and avoiding the morbidity and recovery from undergoing heart surgery. Potential harms include the need for conversion to an open procedure, perioperative death, myocardial infarction, stroke, bleeding, valve embolization, aortic regurgitation, heart block that requires a permanent pacemaker, renal failure, pulmonary failure, and major vascular complications such as cardiac perforation or arterial dissection. Potential long-term harms include death, stroke, valve failure or clotting, and endocarditis. As highlighted at the February 2012 California Technology Assessment Forum meeting, the dispersion of this technology to new centers across the United States must proceed with careful thought given to training and proctoring multidisciplinary teams to become new centers of excellence. TAVR is a potentially lifesaving procedure that may improve quality of life for patients at high risk for surgical AVR. However, attention needs to be paid to appropriate patient selection, their preoperative evaluation, surgical techniques, and

Balloon expandable transcatheter aortic valve implantation with or without pre-dilation of the aortic valve - rationale and design of a multicenter registry (EASE-IT).

PubMed

Bramlage, Peter; Strauch, Justus; Schröfel, Holger

2014-11-18

In patients with severe calcific aortic stenosis, balloon aortic valvuloplasty (BAV) is routinely performed in order to pre-dilate the stenosed aortic valve prior to transcatheter aortic valve implantation (TAVI). Although pre-dilation is considered to be essential for the preparation of the valve landing zone, there is no clear evidence to support its clinical value. In contrast, BAV has been suggested to be linked to several complications. Notably, while preliminary evidence has supported the feasibility and safety of TAVI without pre-dilation, larger studies directly comparing the benefit/risk profile of TAVI in the presence and absence of pre-dilation are required. Therefore, a prospective, two-armed, multicenter registry (EASE-IT) was designed to obtain essential data concerning procedural success rates, adverse events, and mortality in a large cohort of patients undergoing transapical (TA)-TAVI using the Edwards SAPIEN 3 balloon expandable heart valves with and without pre-ballooning. Data provided by EASE-IT will be used to assess the relevance of BAV during the TAVI procedure and to investigate associations between patient characteristics and outcomes. Therefore, results obtained from the EASE-IT registry could contribute to reduced rates of TAVI-associated morbidity and mortality in patients with severe, calcific aortic stenosis. ClinicalTrials.gov Identifier: NCT02127580.

Computational fluid dynamics simulation of transcatheter aortic valve degeneration.

PubMed

Dwyer, Harry A; Matthews, Peter B; Azadani, Ali; Jaussaud, Nicolas; Ge, Liang; Guy, T Sloane; Tseng, Elaine E

2009-08-01

Studied under clinical trials, transcatheter aortic valves (TAV) have demonstrated good short-term feasibility and results in high-risk surgical patients with severe aortic stenosis. However, their long-term safety and durability are unknown. The objective of this study is to evaluate hemodynamic changes within TAV created by bioprosthetic leaflet degeneration. Computational fluid dynamics (CFD) simulations were performed to evaluate the hemodynamics through TAV sclerosis (35% orifice reduction) and stenosis (78% orifice reduction). A three-dimensional surface mesh of the TAV within the aortic root was generated for each simulation. Leaflets were contained within an open, cylindrical body without attachment to the sinus commissures representing the stent. A continuous surface between the annulus and TAV excluded the geometry of the native calcified leaflets and prevented paravalvular leak. Unsteady control volume analysis throughout systole was used to calculate leaflet shear stress and total force on the TAV. Sclerosis increased total force on the TAV by 63% (0.602-0.98 N). Advancement of degeneration from sclerosis to stenosis was accompanied by an 86% increase in total force (1.82 N) but only a 32% increase in peak wall shear stress on the leaflets. Of the total force exerted on the TAV, 99% was in the direction of axial flow. Shear stresses on the TAV were greatest during peak systolic flow with stress concentrations on the tips of the leaflets. In the normal TAV, the aortic root geometry and physiologic flow dominate location and magnitude of shear stress. Following leaflet degeneration, the specific geometry of the stenosis dictates the profile of axial velocity leaving the TAV and shear stress on the leaflets. A dramatic increase in peak leaflet shear stress was observed (115 Pa stenosis vs. 87 Pa sclerosis and 29 Pa normal). CFD simulations in this study provide the first of its kind data quantifying hemodynamics within stenosed TAV. Stenosis leads to

Transcatheter vs Surgical Aortic Valve Replacement for Aortic Stenosis in Low-Intermediate Risk Patients: A Meta-analysis.

PubMed

Tam, Derrick Y; Vo, Thin Xuan; Wijeysundera, Harindra C; Ko, Dennis T; Rocha, Rodolfo Vigil; Friedrich, Jan; Fremes, Stephen E

2017-09-01

Transcatheter aortic valve replacement (TAVR) has emerged as the treatment of choice for patients with severe aortic stenosis at high surgical risk; the role of TAVR compared with surgical aortic valve replacement (SAVR) in the low-intermediate surgical risk population remains uncertain. Our primary objective was to determine differences in 30-day and late mortality in patients treated with TAVR compared with SAVR at low-intermediate risk (Society of Thoracic Surgeons Predicted Risk of Mortality < 10%). Medline and Embase were searched from 2010 to March 2017 for studies that compared TAVR with SAVR in the low-intermediate surgical risk population, restricted to randomized clinical trials and matched observational studies. Two investigators independently abstracted the data and a random effects meta-analysis was performed. Four randomized clinical trials (n = 4042) and 9 propensity score-matched observational studies (n = 4192) were included in the meta-analysis (n = 8234). There was no difference in 30-day mortality between TAVR and SAVR (3.2% vs 3.1%, pooled risk ratio: 1.02; 95% confidence interval, 0.80-1.30; P = 0.89; I 2  = 0%) or mortality at a median of 1.5-year follow-up (incident rate ratio: 1.01; 95% confidence interval, 0.90-1.15; P = 0.83; I 2  = 0%). There was a higher risk of pacemaker implantation and greater than trace aortic insufficiency in the TAVR group whereas the risk of early stroke, atrial fibrillation, acute kidney injury, cardiogenic shock, and major bleeding was higher in the SAVR group. Although there was no difference in 30-day and late mortality, the rate of complications differed between TAVR and SAVR in the low-intermediate surgical risk population. Copyright © 2017 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Effect of transcatheter aortic valve implantation on intraoperative left ventricular end-diastolic pressure.

PubMed

Toyota, Kosaku; Ota, Takashi; Nagamine, Katsutoshi; Koide, Yasuhiro; Nomura, Takeshi; Yamanaka, Futoshi; Shishido, Koki; Tanaka, Masashi; Saito, Shigeru

2016-12-01

Transcatheter aortic valve implantation (TAVI) for patients with aortic stenosis is a less invasive alternative to surgical aortic valve replacement. Despite this, careful anesthetic management, especially strict control of blood pressure and fluid management, is necessary. During TAVI, normalization of left ventricular afterload due to aortic balloon valvuloplasty and prosthetic valve deployment is expected to result in rapid improvement of systolic function and consequent improvement in diastolic function. However, the early effect of TAVI on left ventricular diastolic function is less clear. We hypothesized that TAVI induces a rapid decrease in left ventricular end-diastolic pressure (LVEDP) after valve deployment. This retrospective observational study included 71 patients who had undergone TAVI using the transfemoral approach with a balloon-expandable valve under general anesthesia. Intraoperative LVEDP was measured using an intracardiac catheter. The severity of residual aortic regurgitation (AR) was assessed using the Sellers criteria. The mean (SD) LVEDP was 17.8 (5.3) mmHg just before TAVI and increased significantly to 27.3 (8.2) mmHg immediately after prosthetic valve deployment (p < 0.0001). The change in LVEDP was 8.7 (8.6) mmHg in patients with low residual AR (Sellers ≤1) and 11.0 (7.1) mmHg in those with high residual AR (Sellers ≥2); however, this difference was not significant. No correlation was found between the LVEDP change and intraoperative fluid balance. In conclusion, LVEDP increased significantly in the early period after valve deployment during TAVI, regardless of residual AR severity. It was suggested that the tolerability of fluid load could be reduced at that time.

Device landing zone calcification and its impact on residual regurgitation after transcatheter aortic valve implantation with different devices.

PubMed

Seiffert, Moritz; Fujita, Buntaro; Avanesov, Maxim; Lunau, Clemens; Schön, Gerhard; Conradi, Lenard; Prashovikj, Emir; Scholtz, Smita; Börgermann, Jochen; Scholtz, Werner; Schäfer, Ulrich; Lund, Gunnar; Ensminger, Stephan; Treede, Hendrik

2016-05-01

Calcification of the device landing zone is linked to paravalvular regurgitation after transcatheter aortic valve implantation (TAVI). The mechanisms remain incompletely understood and the performance of next-generation transcatheter heart valves (THV) has not been investigated. We evaluated the impact of calcification patterns on residual aortic regurgitation (AR) after TAVI with different THV in patients with severe aortic stenosis. TAVI was performed in 537 patients at two centres. Devices implanted were the Edwards Sapien XT (n = 254), Medtronic CoreValve (n = 123), JenaValve (n = 62), Medtronic Engager (n = 56), and Symetis Acurate (n = 42) prostheses. Calcification of the device landing zone was retrospectively assessed from contrast-enhanced multidetector computed tomography data and correlated with echocardiographic and clinical data. Calcium volumes of the aortic valve and left-ventricular outflow tract were associated with residual AR: No AR, 604 mm(3) (inter-quartile range, IQR 349-916); trace AR, 639 mm(3) (IQR 368-948); mild AR, 710 mm(3) (IQR 412-2078); ≥moderate AR, 1041 mm(3) (IQR 791-1417, P = 0.001). Device landing zone calcium, particularly if located in the left-ventricular outflow tract, and a low cover index were predictive of AR. Differences in the incidence of AR were observed with regard to THV type. Higher calcium volume was associated with the need for post-dilation (n = 134, median 852 [IQR 342-945] vs. 604 [IQR 542-1207] mm(3), P < 0.001). Calcification of the device landing zone, particularly if located inferior to the annulus, was independently associated with residual AR after TAVI with all evaluated THV; however, the incidence of paravalvular leakage differed significantly between the devices implanted. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

The silent and apparent neurological injury in transcatheter aortic valve implantation study (SANITY): concept, design and rationale

PubMed Central

2014-01-01

Background The incidence of clinically apparent stroke in transcatheter aortic valve implantation (TAVI) exceeds that of any other procedure performed by interventional cardiologists and, in the index admission, occurs more than twice as frequently with TAVI than with surgical aortic valve replacement (SAVR). However, this represents only a small component of the vast burden of neurological injury that occurs during TAVI, with recent evidence suggesting that many strokes are clinically silent or only subtly apparent. Additionally, insult may manifest as slight neurocognitive dysfunction rather than overt neurological deficits. Characterisation of the incidence and underlying aetiology of these neurological events may lead to identification of currently unrecognised neuroprotective strategies. Methods The Silent and Apparent Neurological Injury in TAVI (SANITY) Study is a prospective, multicentre, observational study comparing the incidence of neurological injury after TAVI versus SAVR. It introduces an intensive, standardised, formal neurologic and neurocognitive disease assessment for all aortic valve recipients, regardless of intervention (SAVR, TAVI), valve-type (bioprosthetic, Edwards SAPIEN-XT) or access route (sternotomy, transfemoral, transapical or transaortic). Comprehensive monitoring of neurological insult will also be recorded to more fully define and compare the neurological burden of the procedures and identify targets for harm minimisation strategies. Discussion The SANITY study undertakes the most rigorous assessment of neurological injury reported in the literature to date. It attempts to accurately characterise the insult and sustained injury associated with both TAVI and SAVR in an attempt to advance understanding of this complication and associations thus allowing for improved patient selection and procedural modification. PMID:24708720

Post-introduction observation of transcatheter aortic valve implantation in Galicia (Spain).

PubMed

Varela-Lema, Leonor; Queiro-Verdes, Teresa; Baz-Alonso, José A; Cuenca-Castillo, José J; Durán-Muñoz, Darío; Gónzalez-Juanatey, José R; Herrera Noreña, José M; Iñiguez-Romo, Andrés; López-Otero, Diego; Pradas-Montilla, Gonzalo; Rubio-Álvarez, José; Salgado-Fernández, Jorge; Trillo Nouche, Ramiro; Vázquez-González, Nicolás; López-García, Marisa

2015-02-01

Transcatheter aortic valve implantation constitutes an example of a technology introduced into the Galician Health Care System basket and subjected to a post-introduction observational study after coverage. This paper aims to describe the process and results of this experience, illustrating the main challenges and opportunities in using these studies for supporting decision making. The study protocol was developed by a multidisciplinary team consisting of experts from the Galician HTA Agency (avalia-t), interventional cardiologists and cardiac surgeons. Together they agreed on the information that was relevant and feasible for collection, and planned the study design, data collection and analysis of results. During the 1-year recruitment period, 94 patients underwent percutaneous aortic valve replacement in the three authorized centres. Implantation rate and prosthesis models differed substantially across the centres. Overall, procedural success rate was 96.8% and hospital mortality was 7.4%. Complications during post-surgical admission were recorded in 40.4% of patients. Moderate residual aortic regurgitation was observed in 10% of patients, and the procedure was associated with a stroke rate of 3.3% at 30 days and 5.3% at 1 year. Post-introduction observation has made it feasible to determine the use of this procedure within the SERGAS context and has enabled the assessment of performance in real-life conditions. The proposed strategic actions and interventions have been drawn up based upon the collective judgement of a group of experienced professionals, and have served to establish recommendations on further research that would be required to optimize health benefits. © 2014 John Wiley & Sons, Ltd.

Red cell distribution width in anemic patients undergoing transcatheter aortic valve implantation

PubMed Central

Hellhammer, Katharina; Zeus, Tobias; Verde, Pablo E; Veulemanns, Verena; Kahlstadt, Lisa; Wolff, Georg; Erkens, Ralf; Westenfeld, Ralf; Navarese, Eliano P; Merx, Marc W; Rassaf, Tienush; Kelm, Malte

2016-01-01

AIM: To determine the impact of red blood cell distribution width on outcome in anemic patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: In a retrospective single center cohort study we determined the impact of baseline red cell distribution width (RDW) and anemia on outcome in 376 patients with aortic stenosis undergoing TAVI. All patients were discussed in the institutional heart team and declined for surgical aortic valve replacement due to high operative risk. Collected data included patient characteristics, imaging findings, periprocedural in hospital data, laboratory results and follow up data. Blood samples for hematology and biochemistry analysis were taken from every patient before and at fixed intervals up to 72 h after TAVI including blood count and creatinine. Descriptive statistics were used for patient’s characteristics. Kaplan-Meier survival curves were used for time to event outcomes. A recursive partitioning regression and classification was used to investigate the association between potential risk factors and outcome variables. RESULTS: Mean age in our study population was 81 ± 6.1 years. Anemia was prevalent in 63.6% (n = 239) of our patients. Age and creatinine were identified as risk factors for anemia. In our study population, anemia per se did influence 30-d mortality but did not predict longterm mortality. In contrast, a RDW > 14% showed to be highly predictable for a reduced short- and longterm survival in patients with aortic valve disease after TAVI procedure. CONCLUSION: Age and kidney function determine the degree of anemia. The anisocytosis of red blood cells in anemic patients supplements prognostic information in addition to that derived from the WHO-based definition of anemia. PMID:26981217

Practical considerations for optimizing cardiac computed tomography protocols for comprehensive acquisition prior to transcatheter aortic valve replacement.

PubMed

Khalique, Omar K; Pulerwitz, Todd C; Halliburton, Sandra S; Kodali, Susheel K; Hahn, Rebecca T; Nazif, Tamim M; Vahl, Torsten P; George, Isaac; Leon, Martin B; D'Souza, Belinda; Einstein, Andrew J

2016-01-01

Transcatheter aortic valve replacement (TAVR) is performed frequently in patients with severe, symptomatic aortic stenosis who are at high risk or inoperable for open surgical aortic valve replacement. Computed tomography angiography (CTA) has become the gold standard imaging modality for pre-TAVR cardiac anatomic and vascular access assessment. Traditionally, cardiac CTA has been most frequently used for assessment of coronary artery stenosis, and scanning protocols have generally been tailored for this purpose. Pre-TAVR CTA has different goals than coronary CTA and the high prevalence of chronic kidney disease in the TAVR patient population creates a particular need to optimize protocols for a reduction in iodinated contrast volume. This document reviews details which allow the physician to tailor CTA examinations to maximize image quality and minimize harm, while factoring in multiple patient and scanner variables which must be considered in customizing a pre-TAVR protocol. Copyright © 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

Fluid Dynamics of Thrombosis in Transcatheter Aortic Valves

NASA Astrophysics Data System (ADS)

Seo, Jung Hee; Zhu, Chi; Dou, Zhongwang; Resar, Jon; Mittal, Rajat

2017-11-01

Transcatheter aortic valve replacement (TAVR) with bioprosthetic valves (BPV) has become highly prevalent in recent years. While one advantage of BPVs over mechanical ones is the lower incidence of valve thrombosis, recent clinical studies have suggested a higher than expected incidence of subclinical bioprosthetic valve thrombosis (BVT). Many factors that might affect the transvalvular hemodynamics including the valve position, orientation, stent, and interaction with the coronary flow, have been suggested, but the casual mechanisms of valve thrombosis are still unknown. In the present study, the hemodynamics associated with the formation of BVT is investigated using a novel, coupled flow-structure-biochemical computational modeling. A reduced degree of freedom, fluid-structure-interaction model is proposed for the efficient simulation of the hemodynamics and leaflet dynamics in the BPVs. Simple models to take into account the effects of the stent and coronary flows have also been developed. Simulations are performed for canonical models of BPVs in the aorta in various configurations and the results are examined to provide insights into the mechanisms for valve thrombosis. Supported by the NSF Grants IIS-1344772, CBET-1511200 and NSF XSEDE Grant TG-CTS100002.

Comparative outcomes of transcatheter aortic valve replacement in African American and Caucasian patients with severe aortic stenosis.

PubMed

Alqahtani, Fahad; Aljohani, Sami; Almustafa, Ahmad; Alhijji, Mohammed; Ali, Oluseun; Holmes, David R; Alkhouli, Mohamad

2018-04-01

Racial disparities in cardiovascular care have been extensively investigated. The introduction of transcatheter aortic valve replacement (TAVR) revolutionized the treatment of aortic stenosis (AS) in the last decade. Whether a racial disparity in the utilization and outcome of TAVR exists is unknown. We utilized the nationwide inpatient sample (NIS) to compare utilization rates, and in-hospital outcomes of Caucasians and African American (AA) patients who underwent TAVR between August 2011 and December 2014. A total of 7,176 patients (6870 Caucasians, 95.7%) and (306 AAs, 4.3%) were included in this analysis. Among patients who underwent aortic valve replacement between 2011 and 2014, the rates of TAVR utilization increased from 0.32% to 7.6% in AAs and from 0.4% to 8.8% in Caucasians. In propensity-matched cohorts of patients (n = 300 Caucasians and n = 300 AAs), in-hospital mortality was similar (3.7% and 3.3%, respectively, P = 0.99). Also, rates of key complications including stroke, permanent pacemaker implantation (PPMI), vascular complications, acute kidney injury, new dialysis, blood transfusion, and tamponade were similar in both races. There was also no significant difference between Caucasians and AAs with regards to length of stay, cost of hospitalization, and intermediate care facility utilization. There was no significant difference in the utilization rates, in-hospital outcomes, and cost of TAVR between Caucasians and AA patients in contemporary US practice. Further comparative studies of surgical and TAVR in AAs and other racial minorities are warranted. © 2017 Wiley Periodicals, Inc.

Comparison between transcatheter and surgical aortic valve replacement: a single-center experience.

PubMed

Silberman, Shuli; Abu Akr, Firas; Bitran, Daniel; Almagor, Yaron; Balkin, Jonathan; Tauber, Rachel; Merin, Ofer

2013-07-01

A comparison was made of the outcomes after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (AVR) in high-risk patients. All patients aged > 75 years that underwent a procedure for severe aortic stenosis with or without coronary revascularization at the authors' institution were included in the study; thus, 64 patients underwent TAVI and 188 underwent AVR. Patients in the TAVI group were older (mean age 84 +/- 5 versus 80 +/- 4 years; p < 0.0001) and had a higher logistic EuroSCORE (p = 0.004). Six patients (9%) died during the procedure in the TAVI group, and 23 (12%) died in the AVR group (p = 0.5). Predictors for mortality were: age (p < 0.0001), female gender (p = 0.02), and surgical valve replacement (p = 0.01). Gradients across the implanted valves at one to three months postoperatively were lower in the TAVI group (p < 0.0001). Actuarial survival at one, two and three years was 78%, 64% and 64%, respectively, for TAVI, and 83%, 78% and 75%, respectively, for AVR (p = 0.4). Age was the only predictor for late mortality (p < 0.0001). TAVI patients were older and posed a higher predicted surgical risk. Procedural mortality was lower in the TAVI group, but mid-term survival was similar to that in patients undergoing surgical AVR. Age was the only predictor for late survival. These data support the referral of high-risk patients for TAVI.

The impact of mitral stenosis on outcomes of aortic valve stenosis patient undergoing surgical aortic valve replacement or transcatheter aortic valve replacement.

PubMed

Al-Khadra, Yasser; Darmoch, Fahed; Baibars, Motaz; Kaki, Amir; Fanari, Zaher; Alraies, M Chadi

2018-05-17

The concomitant presence of mitral stenosis (MS) in the setting of symptomatic aortic stenosis represent a clinical challenge. Little is known regarding the outcome of mitral stenosis (MS) patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Therefore, we sought to study the outcome of MS patients undergoing aortic valve replacement (AVR). Using weighted data from the National Inpatient Sample (NIS) database between 2011 and 2014, we identified patients who were diagnosed with MS. Patients who had undergone TAVR as a primary procedure were identified and compared to patients who had SAVR. Univariate and multivariate logistic regression analysis were performed for the outcomes of in-hospital mortality, length of stay (LOS), blood transfusion, postprocedural hemorrhage, vascular, cardiac and respiratory complications, permanent pacemaker placement (PPM), postprocedural stroke, acute kidney injury (AKI), and discharge to an outside facility. A total of 4524 patients were diagnosed with MS, of which 552 (12.2%) had TAVR and 3972 (87.8%) had SAVR. TAVR patients were older (79.9 vs 70.0) with more females (67.4% vs 60.0%) and African American patients (7.7% vs 7.1%) (P < 0.001). In addition, the TAVR group had more comorbidities compared to SAVR in term of coronary artery disease (CAD), congestive heart failure (CHF), chronic lung disease, hypertension (HTN), chronic kidney disease (CKD), and peripheral vascular disease (PVD) (P < 0.001 for all). Using Multivariate logistic regression, and after adjusting for potential risk factors, TAVR patients had lower in-hospital mortality (7.9% vs 8.1% adjusted Odds Ratio [aOR], 0.615; 95% confidence interval [CI], 0.392-0.964, P = 0.034), shorter LOS. Also, TAVR patients had lower rates of cardiac and respiratory complications, PPM, AKI, and discharge to an outside facility compared with the SAVR group. In patients with severe aortic stenosis and concomitant

Revisiting Sex Equality With Transcatheter Aortic Valve Replacement Outcomes: A Collaborative, Patient-Level Meta-Analysis of 11,310 Patients.

PubMed

O'Connor, Stephen A; Morice, Marie-Claude; Gilard, Martine; Leon, Martin B; Webb, John G; Dvir, Danny; Rodés-Cabau, Josep; Tamburino, Corrado; Capodanno, Davide; D'Ascenzo, Fabrizio; Garot, Philippe; Chevalier, Bernard; Mikhail, Ghada W; Ludman, Peter F

2015-07-21

There has been conflicting clinical evidence as to the influence of female sex on outcomes after transcatheter aortic valve replacement. The aim of this study was to evaluate the impact of sex on early and late mortality and safety end points after transcatheter aortic valve replacement using a collaborative meta-analysis of patient-level data. From the MEDLINE, Embase, and the Cochrane Library databases, data were obtained from 5 studies, and a database containing individual patient-level time-to-event data was generated from the registry of each selected study. The primary outcome of interest was all-cause mortality. The safety end point was the combined 30-day safety end points of major vascular complications, bleeding events, and stroke, as defined by the Valve Academic Research Consortium when available. Five studies and their ongoing registry data, comprising 11,310 patients, were included. Women constituted 48.6% of the cohort and had fewer comorbidities than men. Women had a higher rate of major vascular complications (6.3% vs. 3.4%; p < 0.001), major bleeding events (10.5% vs. 8.5%; p = 0.003), and stroke (4.4% vs. 3.6%; p = 0.029) but a lower rate of significant aortic incompetence (grade ≥2; 19.4% vs. 24.5%; p < 0.001). There were no differences in procedural and 30-day mortality between women and men (2.6 % vs. 2.2% [p = 0.24] and 6.5% vs. 6.5% [p = 0.93], respectively), but female sex was independently associated with improved survival at median follow-up of 387 days (interquartile range: 192 to 730 days) from the index procedure (adjusted hazard ratio: 0.79; 95% confidence interval: 0.73 to 0.86; p = 0.001). Although women experience more bleeding events, as well as vascular and stroke complications, female sex is an independent predictor of late survival after transcatheter aortic valve replacement. This should be taken into account during patient selection for this procedure. Copyright © 2015 American College of Cardiology Foundation

Bacterial translocation and plasma cytokines during transcatheter and open-heart aortic valve implantation.

PubMed

Adrie, Christophe; Parlato, Marianna; Salmi, Lynda; Adib-Conquy, Minou; Bical, Olivier; Deleuze, Philippe; Fitting, Catherine; Cavaillon, Jean Marc; Monchi, Mehran

2015-01-01

To determine whether the good safety profile of transarterial aortic valve implantation (TAVI) is related to lower levels of systemic bacterial translocation and systemic inflammation compared with open-heart surgery. Transcatheter aortic valve implantation via the transfemoral approach is increasingly used in very high-risk patients with aortic stenosis. The outcomes seem similar to those after open-heart aortic valve replacement (OHAVR). Each of 26 consecutive high-risk patients (EuroSCORE >20% for risk of operative death) who underwent TAVI (cases) was matched to the first low-risk patient treated next in our department using elective OHAVR without coronary artery bypass (control subjects). We collected severity, outcome, and echocardiography indicators before and after surgery; complications; proinflammatory cytokine levels; and markers for microbial translocation. Despite greater illness severity, the TAVI patients had significantly lower vasopressor agent requirements, lower delirium rates, shorter hospital stays, and better hemodynamic findings compared with OHAVR patients. Vascular complications were more common after TAVI than after OHAVR (12, with seven requiring interventional therapy vs. 0, P = 0.006). Patients who underwent TAVI had lower blood transfusion requirements. Two TAVI patients died: one from iliac artery injury and the other from intracardiac prosthesis migration. Patients who underwent TAVI had lower plasma levels of endotoxin and bacterial peptidoglycan, as well as lower proinflammatory cytokine levels, suggesting less gastrointestinal bacterial translocation compared with OHAVR. Compared with OHAVR, TAVI was associated with decreases in bacterial translocation and inflammation. These differences may explain the lower delirium rate and better hemodynamic stability observed, despite the greater disease severity in TAVI patients.

Comparison of transcatheter aortic valve and surgical bioprosthetic valve durability: a fatigue simulation study

PubMed Central

Martin, Caitlin; Sun, Wei

2015-01-01

Transcatheter aortic valve (TAV) intervention is now the standard-of-care treatment for inoperable patients and a viable alternative treatment option for high-risk patients with symptomatic aortic stenosis. While the procedure is associated with lower operative risk and shorter recovery times than traditional surgical aortic valve (SAV) replacement, TAV intervention is still not considered for lower-risk patients due in part to concerns about device durability. It is well known that bioprosthetic SAVs have limited durability, and TAVs are generally assumed to have even worse durability, yet there is little long-term data to confirm this suspicion. In this study, TAV and SAV leaflet fatigue due to cyclic loading was investigated through finite element analysis by implementing a computational soft tissue fatigue damage model to describe the behavior of the pericardial leaflets. Under identical loading conditions and with identical leaflet tissue properties, the TAV leaflets sustained higher stresses, strains, and fatigue damage compared to the SAV leaflets. The simulation results suggest that the durability of TAVs may be significantly reduced compared to SAVs to about 7.8 years. The developed computational framework may be useful in optimizing TAV design parameters to improve leaflet durability, and assessing the effects of underexpanded, elliptical, or non-uniformly expanded stent deployment on TAV durability. PMID:26294354

Outcomes of Transcatheter and Surgical Aortic Valve Replacement in Patients on Maintenance Dialysis.

PubMed

Alqahtani, Fahad; Aljohani, Sami; Boobes, Khaled; Maor, Elad; Sherieh, Assem; Rihal, Charanjit S; Holmes, David R; Alkhouli, Mohamad

2017-12-01

The introduction of transcatheter aortic valve replacement (TAVR) expanded definitive therapy of aortic stenosis to many high-risk patients, but it has not been fully evaluated in the dialysis population. We aimed to evaluate the current trend and in-hospital outcome of surgical aortic valve replacement (SAVR) and TAVR in the dialysis population. Severe aortic stenosis patients on maintenance dialysis who underwent SAVR or TAVR in the Nationwide Inpatient Sample database from January 1, 2005, through December 31, 2014, were included in our comparative analysis. The trends of SAVR and TAVR were assessed. In-hospital mortality, rates of major adverse events, hospital length of stay, cost of care, and intermediate care facility utilization were compared between the 2 groups using both unadjusted and propensity-matched data. Utilization of aortic valve replacement in dialysis patients increased 3-fold; a total of 2531 dialysis patients who underwent either SAVR (n = 2264) or TAVR (n = 267) between 2005 and 2014 were identified. Propensity score matching yielded 197 matched pairs. After matching, a 2-fold increase in in-hospital mortality was found with SAVR compared with TAVR (13.7% vs 6.1%, P = .021). Patients who underwent TAVR had more permanent pacemaker implantation (13.2% vs 5.6%, P = .012) but less blood transfusion (43.7% vs 56.8%, P = .02). Rates of other key morbidities were similar. Hospital length of stay (19 ± 16 vs 11 ± 11 days, P <.001) and non-home discharges (44.7% vs 31.5%, P = .002) were significantly higher with SAVR. Cost of hospitalization was 25% less with TAVR. In patients on maintenance dialysis, TAVR is associated with lower hospital mortality, resource utilization, and cost in comparison with SAVR. Copyright © 2017 Elsevier Inc. All rights reserved.

Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System.

PubMed

Manoharan, Ganesh; Walton, Antony S; Brecker, Stephen J; Pasupati, Sanjeevan; Blackman, Daniel J; Qiao, Hongyan; Meredith, Ian T

2015-08-24

The purpose of this study was to prospectively evaluate the safety and clinical performance of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system (Medtronic, Inc., Minneapolis, Minnesota) in a single-arm, multicenter pivotal study in high- or extreme-risk patients with symptomatic aortic valve stenosis. Although outcomes following TAVR are improving, challenges still exist. The repositionable 14-F equivalent CoreValve Evolut R TAVR system was developed to mitigate some of these challenges. Suitable patients (n = 60) underwent TAVR with a 26- or 29-mm Evolut R valve. Primary safety endpoints were mortality and stroke at 30 days. Primary clinical performance endpoints were device success per the VARC-2 (Valve Academic Research Consortium-2) and the percent of patients with mild or less aortic regurgitation 24 h to 7 days post-procedure. Patients (66.7% female; mean age 82.8 ± 6.1 years; Society of Thoracic Surgeons Score 7.0 ± 3.7%) underwent TAVR via the transfemoral route in 98.3%, using a 29-mm valve in 68.3% of patients. All attempts at repositioning were successful. No death or stroke was observed up to 30 days. The VARC-2 overall device success rate was 78.6%. Paravalvular regurgitation post TAVR was mild or less in 96.6%, moderate in 3.4%, and severe in 0% at 30 days. Major vascular complications occurred in 8.3%, and permanent pacemaker implantation was required in 11.7% of patients. The repositionable 14-F equivalent Evolut R TAVR system is safe and effective at treating high-risk symptomatic aortic stenosis patients. Repositioning was successful when required in all patients, with low rates of moderate or severe paravalvular aortic regurgitation and low permanent pacemaker implantation. (The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study; NCT01876420). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Clinical and hemodynamic results after direct transcatheter aortic valve replacement versus pre-implantation balloon aortic valvuloplasty: A case-matched analysis.

PubMed

Ferrera, Carlos; Nombela-Franco, Luis; Garcia, Eulogio; Jimenez-Quevedo, Pilar; Biagioni, Corina; Gonzalo, Nieves; Nuñez-Gil, Ivan; Viana-Tejedor, Ana; Salinas, Pablo; Alberto de Agustin, Jose; Almeria, Carlos; Islas, Fabian; Perez de Isla, Leopoldo; Fernandez-Perez, Cristina; Escaned, Javier; Fernández-Ortiz, Antonio; Macaya, Carlos

2017-11-01

To evaluate the safety and midterm hemodynamic results of direct transcatheter aortic valve replacement (TAVR) without pre-implantation balloon aortic valvuloplasty (BAV). BAV was considered a mandatory previous step in TAVR procedures. A total of 339 consecutive patients who underwent transfemoral TAVR were prospectively selected. A 1:1 matching was conducted, pairing age, prosthesis type (self-expandable or balloon expandable) and size, and valve calcification grade (48% with moderate to severe valve calcification). Finally, 102 pairs (102 patients with previous BAV and 102 without BAV) were obtained. Direct TAVR was feasible in all patients without any crossover to BAV group. Device success was achieved in 91.2% and 90.2% of cases in direct TAVR and pre-BAV groups (P = 0.810), respectively, without any differences in balloon postdilation rate and residual aortic regurgitation. The amount of contrast agent, acute kidney injury and myocardial injury was significantly lower in the direct implantation group (P < 0.05). No differences were found in 30-day and 1-year mortality between both groups (4.9% vs. 9.8%, P = 0.177 and 14.0% vs. 23.8%, P = 0.771, respectively). Hemodynamic parameters remained stable after 1-year follow-up in both groups. Direct transfemoral TAVR without prior BAV was safe in patients with calcified severe aortic stenosis. Pre-implantation BAV could be omitted in patients undergoing TAVR, without influence in procedure success rate, and subsequent patients' clinical course and valve hemodynamic performance. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Clinical Relevance of Baseline TCP in Transcatheter Aortic Valve Replacement.

PubMed

Sannino, Anna; Stoler, Robert C; Hebeler, Robert F; Szerlip, Molly; Mack, Michael J; Grayburn, Paul A

2017-10-01

To investigate the influence of baseline thrombocytopenia (TCP) on short-term and long-term outcomes after transcatheter aortic valve replacement (TAVR). A total of 732 consecutive patients with severe, symptomatic aortic stenosis undergoing TAVR from January 2012 to December 2015 were included. Primary outcomes of interest were the relationship of baseline TCP with 30-day and 1-year all-cause mortality. Secondary outcomes of interest were procedural complications and in-hospital mortality in the same subgroups. The prevalence of TCP (defined as platelet count <150 × 109/L) at baseline was 21.9%, of whom 4.0% had moderate/severe TCP (defined as platelet count <100 × 109/L). Compared to no or mild TCP, moderate/severe TCP at baseline was associated with a significantly higher 30-day mortality (23.3% vs 2.3% and 3.1%, respectively; P<.001) and 1-year mortality (40.0% vs 8.3% and 13.4%, respectively; P<.001). In Cox regression analysis, moderate/severe baseline TCP was an independent predictor of 30-day and 1-year mortality (hazard ratio [HR], 13.18; 95% confidence interval [CI], 4.49-38.64; P<.001 and HR, 5.90; 95% CI, 2.68-13.02; P<.001, respectively). In conclusion, baseline TCP is a strong predictor of mortality in TAVR patients, possibly identifying a specific subgroup of frail patients; therefore, it should be taken into account when addressing TAVR risk.

Evaluation of CA125 and NT-proBNP values in patients undergoing transcatheter aortic valve implantation

PubMed Central

Ayhan, Hüseyin; Kasapkara, Hacı Ahmet; Durmaz, Tahir; Keleş, Telat; Sarı, Cenk; Baştuğ, Serdal; Erdoğan, Kemal Eşref; Bayram, Nihal Akar; Bilen, Emine; Akçay, Murat; Bozkurt, Engin

2015-01-01

Background Transcatheter aortic valve implantation (TAVI) is a minimally invasive, emerging therapy in surgically high risk, or inoperable patients. Parameters used for risk classification have some deficiencies in the selection of patients. The objective of this study is to evaluate the impact of TAVI on carbohydrate antigen 125 (CA125) and N-Terminal pro Brain-type Natriuretic Peptide (NT-proBNP) as biomarkers that have been used frequently in recent years, and also the relationship of these biomarkers to prognosis. Methods & Results Transcatheter aortic valve implantation was practiced on 31 patients in this study. Then, CA125 and NT-proBNP levels studied in patients prior to and after the TAVI were evaluated. The patients were also grouped in accordance with their left ventricular ejection fraction (LVEF) and CA125 levels (LVEF ≥ 40% and < 40%; CA125 ≤ 35 U/L and > 35 U/L). The TAVI operation was successfully performed in all patients. There was no in-hospital mortality and substantial improvement in functional capacity was detected at follow ups. In addition, a statistically significant decrease was detected in post-TAVI CA125 and NT-proBNP levels of all patients (CA125 83.8 ± 18.1 U/L vs. 64.3 ± 14.2 U/L, P = 0.008; NT-proBNP: 4633.6 ± 627.6 pg/mL vs. 2866.3 ± 536.8 pg/mL, P < 0.001). In groups divided according to the CA125 levels, there was also statistically significant post-TAVI decline in CA125 levels. Within CA125 > 35 U/L and LVEF < 40% groups, the permanent need for a pacemaker was required in one (3.2%) patient and mortality was observed in two (6.4%) patients after TAVI at follow up. Conclusions The results show that TAVI can be performed effectively and reliably in patients with high baseline levels of CA125 and NT-proBNP. These biomarkers are reduced substantially with TAVI, while high biomarker levels are associated with undesired events, and certainly, these biomarkers can be used for risk classifications in patient selection for TAVI

Cost-Effectiveness of Transcatheter Aortic Valve Replacement With a Self-Expanding Prosthesis Versus Surgical Aortic Valve Replacement.

PubMed

Reynolds, Matthew R; Lei, Yang; Wang, Kaijun; Chinnakondepalli, Khaja; Vilain, Katherine A; Magnuson, Elizabeth A; Galper, Benjamin Z; Meduri, Christopher U; Arnold, Suzanne V; Baron, Suzanne J; Reardon, Michael J; Adams, David H; Popma, Jeffrey J; Cohen, David J

2016-01-05

Previous studies of the cost-effectiveness of transcatheter aortic valve replacement (TAVR) have been based primarily on a single balloon-expandable system. The goal of this study was to evaluate the cost-effectiveness of TAVR with a self-expanding prosthesis compared with surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis and high surgical risk. We performed a formal economic analysis on the basis of individual, patient-level data from the CoreValve U.S. High Risk Pivotal Trial. Empirical data regarding survival and quality of life over 2 years, and medical resource use and hospital costs through 12 months were used to project life expectancy, quality-adjusted life expectancy, and lifetime medical costs in order to estimate the incremental cost-effectiveness of TAVR versus SAVR from a U.S. Relative to SAVR, TAVR reduced initial length of stay an average of 4.4 days, decreased the need for rehabilitation services at discharge, and resulted in superior 1-month quality of life. Index admission and projected lifetime costs were higher with TAVR than with SAVR (differences $11,260 and $17,849 per patient, respectively), whereas TAVR was projected to provide a lifetime gain of 0.32 quality-adjusted life-years ([QALY]; 0.41 LY) with 3% discounting. Lifetime incremental cost-effectiveness ratios were $55,090 per QALY gained and $43,114 per LY gained. Sensitivity analyses indicated that a reduction in the initial cost of TAVR by ∼$1,650 would lead to an incremental cost-effectiveness ratio <$50,000/QALY gained. In a high-risk clinical trial population, TAVR with a self-expanding prosthesis provided meaningful clinical benefits compared with SAVR, with incremental costs considered acceptable by current U.S. With expected modest reductions in the cost of index TAVR admissions, the value of TAVR compared with SAVR in this patient population would become high. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of

Bioprosthetic Valve Fracture to Facilitate Transcatheter Valve-in-Valve Implantation.

PubMed

Allen, Keith B; Chhatriwalla, Adnan K; Cohen, David J; Saxon, John T; Aggarwal, Sanjeev; Hart, Anthony; Baron, Suzanne; Davis, J Russell; Pak, Alex F; Dvir, Danny; Borkon, A Michael

2017-11-01

Valve-in-valve transcatheter aortic valve replacement is less effective in small surgical bioprostheses. We evaluated the feasibility of bioprosthetic valve fracture with a high-pressure balloon to facilitate valve-in-valve transcatheter aortic valve replacement. In vitro bench testing on aortic tissue valves was performed on 19-mm and 21-mm Mitroflow (Sorin, Milan, Italy), Magna and Magna Ease (Edwards Lifesciences, Irvine, CA), Trifecta and Biocor Epic (St. Jude Medical, Minneapolis, MN), and Hancock II and Mosaic (Medtronic, Minneapolis, MN). High-pressure balloons Tru Dilation, Atlas Gold, and Dorado (C.R. Bard, Murray Hill, NJ) were used to determine which valves could be fractured and at what pressure fracture occurred. Mitroflow, Magna, Magna Ease, Mosaic, and Biocor Epic surgical valves were successfully fractured using high-pressures balloon 1 mm larger than the labeled valve size whereas Trifecta and Hancock II surgical valves could not be fractured. Only the internal valve frame was fractured, and the sewing cuff was never disrupted. Manufacturer's rated burst pressures for balloons were exceeded, with fracture pressures ranging from 8 to 24 atmospheres depending on the surgical valve. Testing further demonstrated that fracture facilitated the expansion of previously constrained, underexpanded transcatheter valves (both balloon and self-expanding) to the manufacturer's recommended size. Bench testing demonstrates that the frame of most, but not all, bioprosthetic surgical aortic valves can be fractured using high-pressure balloons. The safety of bioprosthetic valve fracture to optimize valve-in-valve transcatheter aortic valve replacement in small surgical valves requires further clinical investigation. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Advanced transcatheter aortic valve implantation (TAVI) planning from CT with ShapeForest.

PubMed

Swee, Joshua K Y; Grbić, Saša

2014-01-01

Transcatheter aortic valve implantation (TAVI) is becoming a standard treatment for non-operable and high-risk patients with symptomatic severe aortic valve stenosis. As there is no direct view or access to the affected anatomy, comprehensive preoperative planning is crucial for a successful outcome, with the most important decisions made during planning being the selection of the proper implant size, and determining the correct C-arm angulations. While geometric models extracted from 3D images are often used to derive these measurements, the complex shape variation of the AV anatomy found in these patients causes many of the shape representations used to estimate such geometric models to fail in capturing morphological characteristics in sufficient detail. In addition, most current approaches only model the aortic valve (AV), omitting modeling the left ventricle outflow tract (LVOT) entirely despite its high correlation with severe complications such as annulus ruptures, paravalvular leaks and myocardial infarction. We propose a fully automated method to extract patient specific models of the AV and the LVOT, and derive comprehensive biomarkers for accurate TAVI planning. We utilize a novel shape representation--the ShapeForest--which is able to model complex shape variation, preserves local shape information, and incorporates prior knowledge during shape space inference. Extensive quantitative and qualitative experiments performed on 630 volumetric data sets demonstrate an accuracy of 0.69 mm for the AV and 0.83 mm for the LVOT, an improvement of over 16% and 18% respectively when compared against state of the art methods.

Manual, semiautomated, and fully automated measurement of the aortic annulus for planning of transcatheter aortic valve replacement (TAVR/TAVI): analysis of interchangeability.

PubMed

Lou, Junyang; Obuchowski, Nancy A; Krishnaswamy, Amar; Popovic, Zoran; Flamm, Scott D; Kapadia, Samir R; Svensson, Lars G; Bolen, Michael A; Desai, Milind Y; Halliburton, Sandra S; Tuzcu, E Murat; Schoenhagen, Paul

2015-01-01

Preprocedural 3-dimensional CT imaging of the aortic annular plane plays a critical role for transcatheter aortic valve replacement (TAVR) planning; however, manual reconstructions are complex. Automated analysis software may improve reproducibility and agreement between readers but is incompletely validated. In 110 TAVR patients (mean age, 81 years; 37% female) undergoing preprocedural multidetector CT, automated reconstruction of the aortic annular plane and planimetry of the annulus was performed with a prototype of now commercially available software (syngo.CT Cardiac Function-Valve Pilot; Siemens Healthcare, Erlangen, Germany). Fully automated, semiautomated, and manual annulus measurements were compared. Intrareader and inter-reader agreement, intermodality agreement, and interchangeability were analyzed. Finally, the impact of these measurements on recommended valve size was evaluated. Semiautomated analysis required major correction in 5 patients (4.5%). In the remaining 95.5%, only minor correction was performed. Mean manual annulus area was significantly smaller than fully automated results (P < .001 for both readers) but similar to semiautomated measurements (5.0 vs 5.4 vs 4.9 cm(2), respectively). The frequency of concordant recommendations for valve size increased if manual analysis was replaced with the semiautomated method (60% agreement was improved to 82.4%; 95% confidence interval for the difference [69.1%-83.4%]). Semiautomated aortic annulus analysis, with minor correction by the user, provides reliable results in the context of TAVR annulus evaluation. Copyright © 2015 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

Complete filter-based cerebral embolic protection with transcatheter aortic valve replacement.

PubMed

Van Gils, Lennart; Kroon, Herbert; Daemen, Joost; Ren, Claire; Maugenest, Anne-Marie; Schipper, Marguerite; De Jaegere, Peter P; Van Mieghem, Nicolas M

2018-03-01

To evaluate the value of left vertebral artery filter protection in addition to the current filter-based embolic protection technology to achieve complete cerebral protection during TAVR. The occurrence of cerebrovascular events after transcatheter aortic valve replacement (TAVR) has fueled concern for its potential application in younger patients with longer life expectancy. Transcatheter cerebral embolic protection (TCEP) devices may limit periprocedural cerebrovascular events by preventing macro and micro-embolization to the brain. Conventional filter-based TCEP devices cover three extracranial contributories to the brain, yet leave the left vertebral artery unprotected. Patients underwent TAVR with complete TCEP. A dual-filter system was deployed in the brachiocephalic trunk and left common carotid artery with an additional single filter in the left vertebral artery. After TAVR all filters were retrieved and sent for histopathological evaluation by an experienced pathologist. Eleven patients received a dual-filter system and nine of them received an additional left vertebral filter. In the remaining two patients, the left vertebral filter could not be deployed. No periprocedural strokes occurred. We found debris in all filters, consisting of thrombus, tissue derived debris, and foreign body material. The left vertebral filter contained debris in an equal amount of patients as the Sentinel filters. The size of the captured particles was similar between all filters. The left vertebral artery is an important entry route for embolic material to the brain during TAVR. Selective filter protection of the left vertebral artery revealed embolic debris in all patients. The clinical value of complete filter-based TCEP during TAVR warrants further research. © 2017 Wiley Periodicals, Inc.

Sleep in octogenarians during the postoperative phase after transcatheter or surgical aortic valve replacement.

PubMed

Amofah, Hege Andersen; Broström, Anders; Fridlund, Bengt; Bjorvatn, Bjørn; Haaverstad, Rune; Hufthammer, Karl Ove; Kuiper, Karel Kj; Ranhoff, Anette Hylen; Norekvål, Tone M

2016-04-01

Octogenarians with aortic stenosis are an increasing population of patients admitted for surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI). Although adequate sleep is important after illness and surgery, it has scarcely been studied in the immediate postoperative phase. To determine and compare the nature of self-reported sleep and insomnia, and recorded sleep-wake patterns in octogenarians during the in-hospital postoperative phase after SAVR or TAVI. A prospective cohort design was used that included octogenarian patients undergoing SAVR or TAVI at a regional university hospital. Self-reports were used to document sleep and insomnia, and actigraphy was used to record sleep-wake patterns. Data were collected at baseline preoperatively, and then daily for the first five postoperative days. SAVR patients experienced the most insomnia on postoperative nights later in recovery, while TAVI patients experienced the most insomnia on postoperative nights early in recovery. The median total sleep time, as measured by actigraphy, was 6.4 h, and the median sleep efficiency was 79% for the five postoperative nights, but no differences were found between SAVR and TAVI patients on this parameter. All patients slept more during daytime than at night, with SAVR patients having significantly more total sleep hours for all five days than TAVI patients (p < 0.01). Octogenarians with aortic stenosis had disturbed self-reported sleep, increased insomnia, and disturbed sleep-wake patterns postoperatively, resulting in more daytime sleep and inactivity. In patients undergoing SAVR or TAVI, sleep evolves differently during the in-hospital postoperative phase. © The European Society of Cardiology 2015.

Next-Generation Transcatheter Heart Valves: Current Trials in Europe and the USA

PubMed Central

Werner, Nikos; Nickenig, Georg

2012-01-01

Transcatheter aortic valve implantation (TAVI) has proven to be a viable alternative for patients with symptomatic severe aortic stenosis who are at high risk for surgical aortic valve replacement. At the same time, there is increasing evidence that moderate-to-severe periprosthetic aortic regurgitation after TAVI is associated with dramatically increased mortality and morbidity. The issue of proper positioning of the valve, including the ability to reposition and recapture the device, must be dealt with before the use of TAVI can be extended to younger, healthier patients. The next generation of transcatheter heart valves will most likely address repositionability to facilitate accurate placement with additional features that minimize paravalvular leakage. Upcoming devices promise to improve outcomes and usability of current TAVI systems. PMID:22891121

Mortality Risk After Transcatheter Aortic Valve Implantation: Analysis of the Predictive Accuracy of the Transcatheter Valve Therapy Registry Risk Assessment Model.

PubMed

Codner, Pablo; Malick, Waqas; Kouz, Remi; Patel, Amisha; Chen, Cheng-Han; Terre, Juan; Landes, Uri; Vahl, Torsten Peter; George, Isaac; Nazif, Tamim; Kirtane, Ajay J; Khalique, Omar K; Hahn, Rebecca T; Leon, Martin B; Kodali, Susheel

2018-05-08

Risk assessment tools currently used to predict mortality in transcatheter aortic valve implantation (TAVI) were designed for patients undergoing cardiac surgery. We aim to assess the accuracy of the TAVI dedicated American College of Cardiology / Transcatheter Valve Therapies (ACC/TVT) risk score in predicting mortality outcomes. Consecutive patients (n=1038) undergoing TAVI at a single institution from 2014 to 2016 were included. The ACC/TVT registry mortality risk score, the Society of Thoracic Surgeons - Patient Reported Outcomes (STS-PROM) score and the EuroSCORE II were calculated for all patients. In hospital and 30-day all-cause mortality rates were 1.3% and 2.9%, respectively. The ACC/TVT risk stratification tool scored higher for patients who died in-hospital than in those who survived the index hospitalization (6.4 ± 4.6 vs. 3.5 ± 1.6, p = 0.03; respectively). The ACC/TVT score showed a high level of discrimination, C-index for in-hospital mortality 0.74, 95% CI [0.59 - 0.88]. There were no significant differences between the performance of the ACC/TVT registry risk score, the EuroSCORE II and the STS-PROM for in hospital and 30-day mortality rates. The ACC/TVT registry risk model is a dedicated tool to aid in the prediction of in-hospital mortality risk after TAVI.

Quality and Safety in Health Care, Part XXXII: Additional Outcome Predictors for Transcatheter Aortic Valve Replacement.

PubMed

Harolds, Jay A

2018-02-01

Mortality 12 months after a transcatheter aortic valve replacement (TAVR) is partly due to a number of reasons in addition to the usual preprocedural medical patient risk factors. In patients who need a permanent pacemaker placed after the procedure, the mortality risk goes up. The death rate following a TAVR varies considerably at different institutions, and the past death rate of TAVR patients at an institution is predictive of the mortality rate of new patients having this procedure. In addition, the quality of life of the individual before the procedure is predictive of the 12-month mortality outcome after the TAVR is done.

Early outcome of patients undergoing transcatheter aortic valve implantation (TAVI): The Auckland City Hospital experience 2011-2015.

PubMed

Wu, Sylvia S Y; Wang, Tom Kai Ming; Nand, Parma; Ramanathan, Tharumenthiran; Webster, Mark; Stewart, Jim

2016-01-08

Transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement (AVR) in high-risk patients. We report the initial TAVI experience at Auckland City Hospital. The records of patients undergoing TAVI between 2011 and 2015 at Auckland City Hospital were reviewed. We report the procedural success and outcome, including major adverse events (death, stroke, myocardial infarction, bleeding, vascular complications and rehospitalisations), degree of aortic regurgitation and symptom status up to 1-year follow-up. Mean age was 80.7 years and mean Euroscore II and Society of Thoracic Surgeons' scores were 8.2% and 6.3% respectively; 50% had undergone previous cardiac surgery. Successful deployment of the valve was achieved in all patients. The cumulative mortality rates at 30 days, 6 months and 1 year were 2.4%, 6.1% and 12.2% and cumulative stroke rates 1.2%, 3% and 8.2% respectively. Severe aortic regurgitation occurred in 2.3% TAVI is available in the New Zealand public hospital system for patients who are high-risk candidates for AVR. Early results are excellent and indicate that the technology is being used appropriately, according to current access criteria. If the early cost effectiveness data are confirmed, the indications for TAVI may widen.

Impact of Transcatheter Technology on Surgical Aortic Valve Replacement Volume, Outcomes, and Cost.

PubMed

Hawkins, Robert B; Downs, Emily A; Johnston, Lily E; Mehaffey, J Hunter; Fonner, Clifford E; Ghanta, Ravi K; Speir, Alan M; Rich, Jeffrey B; Quader, Mohammed A; Yarboro, Leora T; Ailawadi, Gorav

2017-06-01

Transcatheter aortic valve replacement (TAVR) represents a disruptive technology that is rapidly expanding in use. We evaluated the effect on surgical aortic valve replacement (SAVR) patient selection, outcomes, volume, and cost. A total of 11,565 patients who underwent SAVR, with or without coronary artery bypass grafting (2002 to 2015), were evaluated from the Virginia Cardiac Services Quality Initiative database. Patients were stratified by surgical era: pre-TAVR era (2002 to 2008, n = 5,113), early-TAVR era (2009 to 2011, n = 2,709), and commercial-TAVR era (2012 to 2015, n = 3,743). Patient characteristics, outcomes, and resource utilization were analyzed by univariate analyses. Throughout the study period, statewide SAVR volumes increased with median volumes of pre-TAVR: 722 cases/year, early-TAVR: 892 cases/year, and commercial-TAVR: 940 cases/year (p = 0.005). Implementation of TAVR was associated with declining Society of Thoracic Surgeons predicted risk of mortality among SAVR patients (3.7%, 2.6%, and 2.4%; p < 0.0001), despite increasing rates of comorbid disease. The mortality rate was lowest in the current commercial-TAVR era (3.9%, 4.3%, and 3.2%; p = 0.05), and major morbidity decreased throughout the time period (21.2%, 20.5%, and 15.2%; p < 0.0001). The lowest observed-to-expected ratios for both occurred in the commercial-TAVR era (0.9 and 0.9, respectively). Resource utilization increased generally, including total cost increases from $42,835 to $51,923 to $54,710 (p < 0.0001). At present, SAVR volumes have not been affected by the introduction of TAVR. The outcomes for SAVR continue to improve, potentially due to availability of transcatheter options for high-risk patients. Despite rising costs for SAVR, open approaches still provide a significant cost advantage over TAVR. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

3D printing based on cardiac CT assists anatomic visualization prior to transcatheter aortic valve replacement.

PubMed

Ripley, Beth; Kelil, Tatiana; Cheezum, Michael K; Goncalves, Alexandra; Di Carli, Marcelo F; Rybicki, Frank J; Steigner, Mike; Mitsouras, Dimitrios; Blankstein, Ron

2016-01-01

3D printing is a promising technique that may have applications in medicine, and there is expanding interest in the use of patient-specific 3D models to guide surgical interventions. To determine the feasibility of using cardiac CT to print individual models of the aortic root complex for transcatheter aortic valve replacement (TAVR) planning as well as to determine the ability to predict paravalvular aortic regurgitation (PAR). This retrospective study included 16 patients (9 with PAR identified on blinded interpretation of post-procedure trans-thoracic echocardiography and 7 age, sex, and valve size-matched controls with no PAR). 3D printed models of the aortic root were created from pre-TAVR cardiac computed tomography data. These models were fitted with printed valves and predictions regarding post-implant PAR were made using a light transmission test. Aortic root 3D models were highly accurate, with excellent agreement between annulus measurements made on 3D models and those made on corresponding 2D data (mean difference of -0.34 mm, 95% limits of agreement: ± 1.3 mm). The 3D printed valve models were within 0.1 mm of their designed dimensions. Examination of the fit of valves within patient-specific aortic root models correctly predicted PAR in 6 of 9 patients (6 true positive, 3 false negative) and absence of PAR in 5 of 7 patients (5 true negative, 2 false positive). Pre-TAVR 3D-printing based on cardiac CT provides a unique patient-specific method to assess the physical interplay of the aortic root and implanted valves. With additional optimization, 3D models may complement traditional techniques used for predicting which patients are more likely to develop PAR. Copyright © 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

Bioprosthetic Valve Fracture Improves the Hemodynamic Results of Valve-in-Valve Transcatheter Aortic Valve Replacement.

PubMed

Chhatriwalla, Adnan K; Allen, Keith B; Saxon, John T; Cohen, David J; Aggarwal, Sanjeev; Hart, Anthony J; Baron, Suzanne J; Dvir, Danny; Borkon, A Michael

2017-07-01

Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) may be less effective in small surgical valves because of patient/prosthesis mismatch. Bioprosthetic valve fracture (BVF) using a high-pressure balloon can be performed to facilitate VIV TAVR. We report data from 20 consecutive clinical cases in which BVF was successfully performed before or after VIV TAVR by inflation of a high-pressure balloon positioned across the valve ring during rapid ventricular pacing. Hemodynamic measurements and calculation of the valve effective orifice area were performed at baseline, immediately after VIV TAVR, and after BVF. BVF was successfully performed in 20 patients undergoing VIV TAVR with balloon-expandable (n=8) or self-expanding (n=12) transcatheter valves in Mitroflow, Carpentier-Edwards Perimount, Magna and Magna Ease, Biocor Epic and Biocor Epic Supra, and Mosaic surgical valves. Successful fracture was noted fluoroscopically when the waist of the balloon released and by a sudden drop in inflation pressure, often accompanied by an audible snap. BVF resulted in a reduction in the mean transvalvular gradient (from 20.5±7.4 to 6.7±3.7 mm Hg, P <0.001) and an increase in valve effective orifice area (from 1.0±0.4 to 1.8±0.6 cm 2 , P <0.001). No procedural complications were reported. BVF can be performed safely in small surgical valves to facilitate VIV TAVR with either balloon-expandable or self-expanding transcatheter valves and results in reduced residual transvalvular gradients and increased valve effective orifice area. © 2017 American Heart Association, Inc.

Evaluation of the safety and efficacy of transcatheter aortic valve implantation in patients with a severe stenotic bicuspid aortic valve in a Chinese population*

PubMed Central

Liu, Xian-bao; Jiang, Ju-bo; Zhou, Qi-jing; Pu, Zhao-xia; He, Wei; Dong, Ai-qiang; Feng, Yan; Jiang, Jun; Sun, Yong; Xiang, Mei-xiang; He, Yu-xin; Fan, You-qi; Dong, Liang; Wang, Jian-an

2015-01-01

Objective: The purpose of this study is to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with a severe stenotic bicuspid aortic valve (BAV) in a Chinese population. While several groups have reported the feasibility, efficacy, and safety of TAVI for patients with a BAV, worldwide experience of the technique is still limited, especially in China. Methods: From March 2013 to November 2014, high surgical risk or inoperable patients with symptomatic severe aortic stenosis (AS) who had undergone TAVI at our institution were selected for inclusion in our study. Results were compared between a BAV group and a tricuspid aortic valve (TAV) group. Results: Forty patients were included in this study, 15 (37.5%) of whom were identified as having a BAV. In the BAV group, the aortic valve area was smaller ((0.47±0.13) vs. (0.59±0.14) cm2), the ascending aortic diameter was larger ((40.4±4.4) vs. (36.4±4.3) mm), and the concomitant aortic regurgitation was lower. No significant differences were found between the groups in the other baseline characteristics. No differences were observed either in the choice of access or valve size. The procedural success achieved in this study was 100%. There were no differences between groups in device success (86.7% vs. 88.0%), 30-d mortality (6.7% vs. 8.0%), or 30-d combined end point (13.3% vs. 12.0%). The incidences of new pacemaker implantation, paravalvular regurgitation and other complications, recovery of left ventricle ejection fraction and heart function were similar in both groups. Conclusions: Patients with a severely stenotic BAV can be treated with TAVI, and their condition after treatment should be similar to that of people with a TAV. PMID:25743122

Transcatheter Aortic Valve Replacement by a Novel Suprasternal Approach.

PubMed

Codner, Pablo; Pugliese, Daniel; Kouz, Rémi; Patel, Amisha; Chen, Cheng-Han; Terre, Juan; Eudailey, Kyle W; Nazif, Tamim; Vahl, Torsten P; George, Isaac; Khalique, Omar K; Hahn, Rebecca T; Leon, Martin B; Kodali, Susheel; Borger, Michael

2018-04-01

Transcatheter aortic valve replacement (TAVR) provides therapy for patients with severe aortic stenosis at extreme, high, or intermediate surgical risk. Transfemoral access has been the preferred access route; however, this approach is not suitable for many TAVR candidates. A suprasternal approach may allow for earlier ambulation and shorter hospital stay as compared with other, nontransfemoral approaches. A total of 11 patients with unsuitable transfemoral access underwent suprasternal TAVR. Propensity matching was used to compare suprasternal patients to patients undergoing transaortic, transapical, and trans-subclavian TAVR. Groups were well matched for baseline characteristics. A self-expanding valve device was used in 6 (54.5%) and a balloon-expandable valve in 5 (45.5%) of the 11 patients treated by the suprasternal route. Suprasternal and trans-subclavian patients were able to ambulate earlier than patients treated by the transaortic route, a median 1.6 days (interquartile range [IQR]: 0.9 to 1.8), 1.6 days (IQR: 0.9 to 2.7), and 3.9 days (IQR: 1.9 to 4.5) after the procedure for suprasternal, trans-subclavian, and transaortic patients, respectively (p = 0.001). Length of hospitalization was shorter for patients treated by suprasternal or trans-subclavian access in comparison with patients treated by the transaortic or transapical approach: median 4 days (IQR: 3 to 8) and 4 days (IQR: 4 to 8) versus 8 days (IQR: 6 to 14) and 6 days (IQR: 7 to 11) for suprasternal and trans-subclavian versus transaortic and transapical, respectively (p = 0.01). Suprasternal and trans-subclavian access are associated with earlier ambulation and shorter hospitalization than other nontransfemoral TAVR routes, without an increase in complications. Further study is required to determine if suprasternal is the alternative access of choice for TAVR patients with poor transfemoral vasculature. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights

[Feasibility Study of Dual-source Computed Tomography High-pitch Scan Mode in Preoperative Evaluation of Aortic Stenosis Referred to Transcatheter Aortic Valve Implantation].

PubMed

Peng, Liqing; Yu, Jianqun; Li, Zhenlin; Li, Wanjiang; Cheng, Wei

2016-10-01

The purpose of this study was to explore the feasibility of dual-source computed tomography(DSCT)highpitch scan mode in the preoperative evaluation of severe aortic stenosis(AS)referred to transcatheter aortic valve implantation(TAVI).Thirty patients with severe AS referred for TAVI underwent cervico-femoral artery joint DSCT angiography.Measurement and calculation of contrast,contrast noise ratio(CNR)and noise of aorta and access vessels were performed.The intra-and inter-observer reproducibilities for assessing aortic root and access vessels were evaluated.Evaluation of shape and plagues of aorta and access vessels was performed.The contrast,CNR and noise of aorta and access vessels were 348.2~457.9HU,12.2~30.3HU and 19.1~48.1 HU,respectively.There were good intra-and inter-observer reproducibilities in assessing aortic root and access vessels by DSCT(mean difference:-0.73~0.79 mm,r=0.90~0.98,P<0.001;mean difference:-0.70~0.73 mm,r=0.90~0.96,P<0.001).In the 30 patients,the diameters of external iliac artery,femeral artery or subclavian artery were less than 7mm in 5cases(16.7%),marked calcification in bilateral common iliac arteries in 1case(3.3%)and marked soft plaque in left common iliac artery in 1case(3.3%).DSCT high-pitch scan mode was feasible in the preoperative evaluation of aorta and access vessels in patients with AS referred for TAVI.

Transcatheter aortic-valve implantation with one single minimal contrast media injection.

PubMed

Arrigo, Mattia; Maisano, Francesco; Haueis, Sabine; Binder, Ronald K; Taramasso, Maurizio; Nietlispach, Fabian

2015-06-01

Performing transcatheter aortic valve implantation (TAVI) with the use of minimal contrast in patients at high-risk for acute kidney injury (AKI). Contrast-induced nephropathy (CIN) is a major cause of AKI following TAVI and is associated with increased morbidity and mortality. The amount of contrast media used increases the risk for CIN. Computed tomography was omitted during the screening process. For the procedure transfemoral access was default. The self-expanding CoreValve prosthesis was chosen in all patients to minimize the risk of annular rupture in case of oversizing. Valve sizing was based on echocardiography, aortography, calcification on fluoroscopy, as well as weight and height of the patient. A single contrast injection was performed to confirm correct position of the pigtail catheter at the level of the annulus. The pigtail then served as the marker for the device landing zone. Intraprocedural assessment of the implantation result relied on echocardiography and hemodynamics. Five patients with severe aortic stenosis and at high risk for developing CIN were included. Device success was achieved in all patients and no major complications occurred. The median dose of injected contrast media was 8 ml (4-9). All but one patient had improved renal function after the intervention compared to baseline. Our study shows feasibility of performing TAVI with a single minimal contrast media injection, using a self-expandable valve. This technique has the potential to reduce the incidence of CIN. © 2015 Wiley Periodicals, Inc.

Prognostic Value of Improved Kidney Function After Transcatheter Aortic Valve Implantation for Aortic Stenosis.

PubMed

Nijenhuis, Vincent Johan; Peper, Joyce; Vorselaars, Veronique M M; Swaans, Martin J; De Kroon, Thom; Van der Heyden, Jan A S; Rensing, Benno J W M; Heijmen, Robin; Bos, Willem-Jan W; Ten Berg, Jurrien M

2018-05-15

Transcatheter aortic valve implantation (TAVI) is associated with acute kidney injury (AKI), but can also improve the kidney function (IKF). We assessed the effects of kidney function changes in relation to baseline kidney function on 2-year clinical outcomes after TAVI. In total, 639 consecutive patients with aortic stenosis who underwent TAVI were stratified into 3 groups according to the ratio of serum creatinine post- to pre-TAVI: IKF (≤0.80; n = 95 [15%]), stable kidney function (0.80 to 1.5; n = 477 [75%]), and AKI (≥1.5; n = 67 [10%]). Different AKI risk scores were compared using receiving-operator characteristics. Median follow-up was 24 (8 to 44) months. At 3 months, the increase in estimated glomerular filtration rate in the IKF group remained, and the decreased estimated glomerular filtration rate in the AKI group recovered. Compared with a stable kidney function, AKI showed a higher 2-year mortality rate (adjusted hazard ratio [HR] 3.69, 95% confidence interval [CI] 2.43 to 5.62) and IKF a lower mortality rate (adjusted hazard ratio 0.53, 95% CI 0.30 to 0.93). AKI also predicted major and life-threatening bleeding (adjusted odds ratio 2.94, 95% CI 1.27 to 6.78). Independent predictors of AKI were chronic kidney disease and pulmonary hypertension. Independent predictors of IKF were female gender, a preserved kidney function, absence of atrial fibrillation, and hemoglobin level. Established AKI risk scores performed moderately and did not differentiate between AKI and IKF. In conclusion, AKI is transient and is independently associated with a higher mortality rate, whereas IKF is sustained and is associated with a lower mortality rate. These effects are independent of baseline kidney function. Further studies are warranted to investigate the role of IKF and generate a dedicated prediction model. Copyright © 2018 Elsevier Inc. All rights reserved.

Computer-aided design of the human aortic root.

PubMed

Ovcharenko, E A; Klyshnikov, K U; Vlad, A R; Sizova, I N; Kokov, A N; Nushtaev, D V; Yuzhalin, A E; Zhuravleva, I U

2014-11-01

The development of computer-based 3D models of the aortic root is one of the most important problems in constructing the prostheses for transcatheter aortic valve implantation. In the current study, we analyzed data from 117 patients with and without aortic valve disease and computed tomography data from 20 patients without aortic valvular diseases in order to estimate the average values of the diameter of the aortic annulus and other aortic root parameters. Based on these data, we developed a 3D model of human aortic root with unique geometry. Furthermore, in this study we show that by applying different material properties to the aortic annulus zone in our model, we can significantly improve the quality of the results of finite element analysis. To summarize, here we present four 3D models of human aortic root with unique geometry based on computational analysis of ECHO and CT data. We suggest that our models can be utilized for the development of better prostheses for transcatheter aortic valve implantation. Copyright © 2014 Elsevier Ltd. All rights reserved.

Multi-physics 3D computational study of leaflet thrombus formation following surgical and transcatheter aortic valve replacement

NASA Astrophysics Data System (ADS)

Vahidkhah, Koohyar; Abbasi, Mostafa; Barakat, Mohammed; Dvir, Danny; Azadani, Ali

2017-11-01

An increasingly recognized complication following surgical/transcatheter aortic valve replacement is thrombosis or blood clot formation on replacement valve leaflets. A predisposing factor in thrombus formation on biomaterial surfaces of a bioprosthetic heart valve is blood stasis. Longer residence time of blood provides an opportunity for platelets and agonists to accumulate to critical concentrations that leads to platelet activation and then thrombosis. In this study, we have developed a fluid-solid interaction (FSI) modeling approach, to quantify blood stasis on the leaflets of bioprosthetic aortic valves with different design operating in a patient-specific geometry. We have validated our FSI model against experimental measurements of valve opening/closing as well as in-vitro particle image velocimetry. We have also embedded in our method a model for transport of platelets and agonists (ADP, TxA2, and thrombin) and their interactions that result in platelets activation and adhesion to biomaterial bioprosthetic surfaces. We have provided quantitative evidence for the correlation between long residence of blood on bioprosthetic aortic valve leaflets and formation of high thrombogenicity risk regions on the leaflets that are characterized by accumulation of activated platelet.

Optimal prosthesis sizing in transcatheter aortic valve implantation by exclusive use of three-dimensional transoesophageal echocardiography.

PubMed

Kretzschmar, Daniel; Lauten, Alexander; Goebel, Bjoern; Doenst, Torsten; Poerner, Tudor C; Ferrari, Markus; Figulla, Hans R; Hamadanchi, Ali

2016-03-01

The assessment of aortic annular size is critical, and inappropriate sizing is thought to be a main reason of paravalvular aortic regurgitation. Multidetector computed tomograph is associated with the risk of contrast nephropathy. For optimal evaluation of the complex structure of the aortic annulus, three-dimensional (3D)-methods should be used. We therefore sought to determine the value of 3D-transoesophageal echocardiography (3D-TEE) for appropriate sizing. Hundred and one patients (mean age 81·4 years) with symptomatic aortic valve stenosis (AS) and high surgical risk profile (mean log. EuroScore 28·8%) being scheduled for transcatheter aortic valve implantation (TAVI) were included. 2D- and 3D-TEE were performed before the procedure to evaluate the aortic annulus diameter. Maximum, minimum and mean (max diameter + min diameter/2) annulus diameters were 24·7, 23·1 and 23. 9 mm in 3D-TEE and compared to 22·6 mm in 2D-TEE (P<0·001; 0·07; <0·001). The interobserver variability for 3D-TEE was low with a mean difference of 0·18 mm compared to 2D-TEE with 0·59 mm. The application of 3D-TEE caused a change of prosthesis size selection in 40% of patients compared to 2D-TEE. In this study, we implanted three different types of catheter-mounted valves (Edwards-SAPIEN(™) XT valve, CoreValve(™) and JenaValve(™) ). Final angiography confirmed valve competence (mild insufficiency) in 91%, and there was no aortic regurgitation greater than moderate in the follow-up echocardiographic evaluation. Assessment of aortic annulus dimensions for TAVI size selection can safely be performed with 3D-TEE only. Based on our results with significantly higher annulus diameter compared to 2D-TEE, we recommend 3D-TEE to reduce prosthesis undersizing. © 2014 Scandinavian Society of Clinical Physiology and Nuclear Medicine. Published by John Wiley & Sons Ltd.

Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study.

PubMed

Sawaya, Fadi J; Deutsch, Marcus-André; Seiffert, Moritz; Yoon, Sung-Han; Codner, Pablo; Wickramarachchi, Upul; Latib, Azeem; Petronio, A Sonia; Rodés-Cabau, Josep; Taramasso, Maurizio; Spaziano, Marco; Bosmans, Johan; Biasco, Luigi; Mylotte, Darren; Savontaus, Mikko; Gheeraert, Peter; Chan, Jason; Jørgensen, Troels H; Sievert, Horst; Mocetti, Marco; Lefèvre, Thierry; Maisano, Francesco; Mangieri, Antonio; Hildick-Smith, David; Kornowski, Ran; Makkar, Raj; Bleiziffer, Sabine; Søndergaard, Lars; De Backer, Ole

2017-05-22

The aim of this study was to evaluate the use of transcatheter heart valves (THV) for the treatment of noncalcific pure native aortic valve regurgitation (NAVR) and failing bioprosthetic surgical heart valves (SHVs) with pure severe aortic regurgitation (AR). Limited data are available about the "off-label" use of transcatheter aortic valve replacement (TAVR) to treat pure severe AR. The study population consisted of patients with pure severe AR treated by TAVR at 18 different centers. Study endpoints were device success, early safety, and clinical efficacy at 30 days, as defined by Valve Academic Research Consortium 2 criteria. A total of 146 patients were included, 78 patients in the NAVR group and 68 patients in the failing SHV group. In the NAVR group, device success, early safety, and clinical efficacy were 72%, 66%, and 61%, respectively. Device success and clinical efficacy were significantly better with newer generation THVs compared with old-generation THVs (85% vs. 54% and 75% vs. 46%, respectively, p < 0.05); this was mainly due to less second THV implantations and a lower rate of moderate to severe paravalvular regurgitation (10% vs. 24% and 3% vs. 27%, respectively). Independent predictors of 30-day mortality were body mass index <20 kg/m 2 , STS surgical risk score >8%, major vascular or access complication, and moderate to severe AR. In the failing SHV group, device success, early safety, and clinical efficacy were 71%, 90%, and 77%, respectively. TAVR for pure NAVR remains a challenging condition, with old-generation THVs being associated with THV embolization and migration and significant paravalvular regurgitation. Newer generation THVs show more promising outcomes. For those patients with severe AR due to failing SHVs, TAVR is a valuable therapeutic option. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Association Between Transcatheter Aortic Valve Replacement and Subsequent Infective Endocarditis and In-Hospital Death.

PubMed

Regueiro, Ander; Linke, Axel; Latib, Azeem; Ihlemann, Nikolaj; Urena, Marina; Walther, Thomas; Husser, Oliver; Herrmann, Howard C; Nombela-Franco, Luis; Cheema, Asim N; Le Breton, Hervé; Stortecky, Stefan; Kapadia, Samir; Bartorelli, Antonio L; Sinning, Jan Malte; Amat-Santos, Ignacio; Munoz-Garcia, Antonio; Lerakis, Stamatios; Gutiérrez-Ibanes, Enrique; Abdel-Wahab, Mohamed; Tchetche, Didier; Testa, Luca; Eltchaninoff, Helene; Livi, Ugolino; Castillo, Juan Carlos; Jilaihawi, Hasan; Webb, John G; Barbanti, Marco; Kodali, Susheel; de Brito, Fabio S; Ribeiro, Henrique B; Miceli, Antonio; Fiorina, Claudia; Dato, Guglielmo Mario Actis; Rosato, Francesco; Serra, Vicenç; Masson, Jean-Bernard; Wijeysundera, Harindra C; Mangione, Jose A; Ferreira, Maria-Cristina; Lima, Valter C; Carvalho, Luiz A; Abizaid, Alexandre; Marino, Marcos A; Esteves, Vinicius; Andrea, Julio C M; Giannini, Francesco; Messika-Zeitoun, David; Himbert, Dominique; Kim, Won-Keun; Pellegrini, Costanza; Auffret, Vincent; Nietlispach, Fabian; Pilgrim, Thomas; Durand, Eric; Lisko, John; Makkar, Raj R; Lemos, Pedro A; Leon, Martin B; Puri, Rishi; San Roman, Alberto; Vahanian, Alec; Søndergaard, Lars; Mangner, Norman; Rodés-Cabau, Josep

2016-09-13

Limited data exist on clinical characteristics and outcomes of patients who had infective endocarditis after undergoing transcatheter aortic valve replacement (TAVR). To determine the associated factors, clinical characteristics, and outcomes of patients who had infective endocarditis after TAVR. The Infectious Endocarditis after TAVR International Registry included patients with definite infective endocarditis after TAVR from 47 centers from Europe, North America, and South America between June 2005 and October 2015. Transcatheter aortic valve replacement for incidence of infective endocarditis and infective endocarditis for in-hospital mortality. Infective endocarditis and in-hospital mortality after infective endocarditis. A total of 250 cases of infective endocarditis occurred in 20 006 patients after TAVR (incidence, 1.1% per person-year; 95% CI, 1.1%-1.4%; median age, 80 years; 64% men). Median time from TAVR to infective endocarditis was 5.3 months (interquartile range [IQR], 1.5-13.4 months). The characteristics associated with higher risk of progressing to infective endocarditis after TAVR was younger age (78.9 years vs 81.8 years; hazard ratio [HR], 0.97 per year; 95% CI, 0.94-0.99), male sex (62.0% vs 49.7%; HR, 1.69; 95% CI, 1.13-2.52), diabetes mellitus (41.7% vs 30.0%; HR, 1.52; 95% CI, 1.02-2.29), and moderate to severe aortic regurgitation (22.4% vs 14.7%; HR, 2.05; 95% CI, 1.28-3.28). Health care-associated infective endocarditis was present in 52.8% (95% CI, 46.6%-59.0%) of patients. Enterococci species and Staphylococcus aureus were the most frequently isolated microorganisms (24.6%; 95% CI, 19.1%-30.1% and 23.3%; 95% CI, 17.9%-28.7%, respectively). The in-hospital mortality rate was 36% (95% CI, 30.0%-41.9%; 90 deaths; 160 survivors), and surgery was performed in 14.8% (95% CI, 10.4%-19.2%) of patients during the infective endocarditis episode. In-hospital mortality was associated with a higher logistic EuroSCORE (23.1% vs 18.6%; odds ratio

Rationale and design of the Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure (TAVR UNLOAD) trial.

PubMed

Spitzer, Ernest; Van Mieghem, Nicolas M; Pibarot, Philippe; Hahn, Rebecca T; Kodali, Susheel; Maurer, Mathew S; Nazif, Tamim M; Rodés-Cabau, Josep; Paradis, Jean-Michel; Kappetein, Arie-Pieter; Ben-Yehuda, Ori; van Es, Gerrit-Anne; Kallel, Faouzi; Anderson, William N; Tijssen, Jan; Leon, Martin B

2016-12-01

Coexistence of moderate aortic stenosis (AS) in patients with heart failure (HF) with reduced ejection fraction is not uncommon. Moderate AS increases afterload, whereas pharmacologic reduction of afterload is a pillar of contemporary HF management. Unloading the left ventricle by reducing the transaortic gradient with transfemoral transcatheter aortic valve replacement (TAVR) may improve clinical outcomes in patients with moderate AS and HF with reduced ejection fraction. The TAVR UNLOAD (NCT02661451) is an international, multicenter, randomized, open-label, clinical trial comparing the efficacy and safety of TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve in addition to optimal heart failure therapy (OHFT) vs OHFT alone in patients with moderate AS (defined by a mean transaortic gradient ≥20 mm Hg and <40 mm Hg, and an aortic valve area >1.0 cm 2 and ≤1.5 cm 2 at rest or after dobutamine stress echocardiography) and reduced ejection fraction. A total of 600 patients will be randomized in a 1:1 fashion. Clinical follow-up is scheduled at 1, 6, and 12 months, and 2 years after randomization. The primary end point is the hierarchical occurrence of all-cause death, disabling stroke, hospitalizations related to HF, symptomatic aortic valve disease or nondisabling stroke, and the change in the Kansas City Cardiomyopathy Questionnaire at 1 year. Secondary end points capture effects on clinical outcome, biomarkers, echocardiographic parameters, and quality of life. The TAVR UNLOAD trial aims to test the hypothesis that TAVR on top of OHFT improves clinical outcomes in patients with moderate AS and HF with reduced ejection fraction. Copyright © 2016 Elsevier Inc. All rights reserved.

Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation.

PubMed

Yoon, Sung-Han; Schmidt, Tobias; Bleiziffer, Sabine; Schofer, Niklas; Fiorina, Claudia; Munoz-Garcia, Antonio J; Yzeiraj, Ermela; Amat-Santos, Ignacio J; Tchetche, Didier; Jung, Christian; Fujita, Buntaro; Mangieri, Antonio; Deutsch, Marcus-Andre; Ubben, Timm; Deuschl, Florian; Kuwata, Shingo; De Biase, Chiara; Williams, Timothy; Dhoble, Abhijeet; Kim, Won-Keun; Ferrari, Enrico; Barbanti, Marco; Vollema, E Mara; Miceli, Antonio; Giannini, Cristina; Attizzani, Guiherme F; Kong, William K F; Gutierrez-Ibanes, Enrique; Jimenez Diaz, Victor Alfonso; Wijeysundera, Harindra C; Kaneko, Hidehiro; Chakravarty, Tarun; Makar, Moody; Sievert, Horst; Hengstenberg, Christian; Prendergast, Bernard D; Vincent, Flavien; Abdel-Wahab, Mohamed; Nombela-Franco, Luis; Silaschi, Miriam; Tarantini, Giuseppe; Butter, Christian; Ensminger, Stephan M; Hildick-Smith, David; Petronio, Anna Sonia; Yin, Wei-Hsian; De Marco, Federico; Testa, Luca; Van Mieghem, Nicolas M; Whisenant, Brian K; Kuck, Karl-Heinz; Colombo, Antonio; Kar, Saibal; Moris, Cesar; Delgado, Victoria; Maisano, Francesco; Nietlispach, Fabian; Mack, Michael J; Schofer, Joachim; Schaefer, Ulrich; Bax, Jeroen J; Frerker, Christian; Latib, Azeem; Makkar, Raj R

2017-12-05

Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR). This study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR. From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices. A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR ≥ moderate (4.2% vs. 18.8%; p < 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001). Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR

Valve in valve transcatheter aortic valve implantation (ViV-TAVI) versus redo-Surgical aortic valve replacement (redo-SAVR): A systematic review and meta-analysis.

PubMed

Nalluri, Nikhil; Atti, Varunsiri; Munir, Abdullah B; Karam, Boutros; Patel, Nileshkumar J; Kumar, Varun; Vemula, Praveen; Edla, Sushruth; Asti, Deepak; Paturu, Amrutha; Gayam, Sriramya; Spagnola, Jonathan; Barsoum, Emad; Maniatis, Gregory A; Tamburrino, Frank; Kandov, Ruben; Lafferty, James; Kliger, Chad

2018-05-20

Bioprosthetic (BP) valves have been increasingly used for aortic valve replacement over the last decade. Due to their limited durability, patients presenting with failed BP valves are rising. Valve in Valve - Transcatheter Aortic Valve Implantation (ViV-TAVI) emerged as an alternative to the gold standard redo-Surgical Aortic Valve Replacement (redo-SAVR). However, the utility of ViV-TAVI is poorly understood. A systematic electronic search of the scientific literature was done in PubMed, EMBASE, SCOPUS, Google Scholar, and ClinicalTrials.gov. Only studies which compared the safety and efficacy of ViV-TAVI and redo-SAVR head to head in failed BP valves were included. Six observational studies were eligible and included 594 patients, of whom 255 underwent ViV- TAVI and 339 underwent redo-SAVR. There was no significant difference between ViV-TAVI and redo- SAVR for procedural, 30 day and 1 year mortality rates. ViV-TAVI was associated with lower risk of permanent pacemaker implantation (PPI) (OR: 0.43, CI: 0.21-0.89; P = 0.02) and a trend toward increased risk of paravalvular leak (PVL) (OR: 5.45, CI: 0.94-31.58; P = 0.06). There was no significant difference for stroke, major bleeding, vascular complications and postprocedural aortic valvular gradients more than 20 mm-hg. Our results reiterate the safety and feasibility of ViV-TAVI for failed aortic BP valves in patients deemed to be at high risk for surgery. VIV-TAVI was associated with lower risk of permanent pacemaker implantation with a trend toward increased risk of paravalvular leak. © 2018, Wiley Periodicals, Inc.

Relation between calcium burden, echocardiographic stent frame eccentricity and paravalvular leakage after corevalve transcatheter aortic valve implantation.

PubMed

Di Martino, Luigi F M; Soliman, Osama I I; van Gils, Lennart; Vletter, Wim B; Van Mieghem, Nicolas M; Ren, Ben; Galema, Tjebbe W; Schultz, Carl; de Jaegere, Peter P T; Di Biase, Matteo; Geleijnse, Marcel L

2017-06-01

Paravalvular aortic leakage (PVL) after transcatheter aortic valve implantation (TAVI) is a complication with potentially severe consequences. The relation between native aortic root calcium burden, stent frame eccentricity and PVL was not studied before. Two-hundred-and-twenty-three consecutive patients with severe aortic stenosis who underwent TAVI with a Medtronic CoreValve System© and who had available pre-discharge transthoracic echocardiography were studied. Echocardiographic stent inflow frame eccentricity was defined as major-minor diameter in a short-axis view >2 mm. PVL was scored according to the updated Valve Academic Research Consortium (VARC-2) recommendations. In a subgroup of 162 (73%) patients, the calcium Agatston score was available. Stent frame eccentricity was seen in 77 (35%) of patients. The correlation between the Agatston score and stent frame eccentricity was significant (ρ = 0.241, P = 0.003). Paravalvular leakage was absent in 91 cases (41%), mild in 67 (30%), moderate in 51 (23%), and severe in 14 (6%) cases. The correlation between stent frame eccentricity and PVL severity was significant (ρ = 0.525, P < 0.0001). There was a relation between particular eccentric stent frame shapes and the site of PVL. Calcification of the aortic annulus is associated with a subsequent eccentric shape of the CoreValve prosthesis. This eccentric shape results in more PVL, with the localization of PVL related to the shape of stent frame eccentricity. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

A meta-analysis and meta-regression of long-term outcomes of transcatheter versus surgical aortic valve replacement for severe aortic stenosis.

PubMed

Villablanca, Pedro A; Mathew, Verghese; Thourani, Vinod H; Rodés-Cabau, Josep; Bangalore, Sripal; Makkiya, Mohammed; Vlismas, Peter; Briceno, David F; Slovut, David P; Taub, Cynthia C; McCarthy, Patrick M; Augoustides, John G; Ramakrishna, Harish

2016-12-15

Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to surgical aortic-valve replacement (SAVR) for patients with severe symptomatic aortic stenosis (AS) who are at high operative risk. We sought to determine the long-term (≥1year follow-up) safety and efficacy TAVR compared with SAVR in patients with severe AS. A comprehensive search of PubMed, EMBASE, Cochrane Central Register of Controlled Trials, conference proceedings, and relevant Web sites from inception through 10 April 2016. Fifty studies enrolling 44,247 patients met the inclusion criteria. The mean duration follow-up was 21.4months. No difference was found in long-term all-cause mortality (risk ratios (RR), 1.06; 95% confidence interval (CI) 0.91-1.22). There was a significant difference favoring TAVR in the incidence of stroke (RR, 0.82; 95% CI 0.71-0.94), atrial fibrillation (RR, 0.43; 95% CI 0.33-0.54), acute kidney injury (RR, 0.70; 95% CI 0.53-0.92), and major bleeding (RR, 0.57; 95% CI 0.40-0.81). TAVR had significant higher incidence of vascular complications (RR, 2.90; 95% CI 1.87-4.49), aortic regurgitation (RR, 7.00; 95% CI 5.27-9.30), and pacemaker implantation (PPM) (RR, 2.02; 95% CI 1.51-2.68). TAVR demonstrated significantly lower stroke risk compared to SAVR in high-risk patients (RR, 1.49; 95% CI 1.06-2.10); no differences in PPM implantation were observed in intermediate-risk patients (RR, 1.68; 95% CI 0.94-3.00). In a meta-regression analysis, the effect of TAVR baseline clinical features did not affect the long-term all-cause mortality outcome. TAVR and SAVR showed similar long-term survival in patients with severe AS; with important differences in treatment-associated morbidity. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Impact of mitral regurgitation on clinical outcomes of patients with low-ejection fraction, low-gradient severe aortic stenosis undergoing transcatheter aortic valve implantation.

PubMed

O'Sullivan, Crochan J; Stortecky, Stefan; Bütikofer, Anne; Heg, Dik; Zanchin, Thomas; Huber, Christoph; Pilgrim, Thomas; Praz, Fabien; Buellesfeld, Lutz; Khattab, Ahmed A; Blöchlinger, Stefan; Carrel, Thierry; Meier, Bernhard; Zbinden, Stephan; Wenaweser, Peter; Windecker, Stephan

2015-02-01

Up to 1 in 6 patients undergoing transcatheter aortic valve implantation (TAVI) present with low-ejection fraction, low-gradient (LEF-LG) severe aortic stenosis and concomitant relevant mitral regurgitation (MR) is present in 30% to 55% of these patients. The effect of MR on clinical outcomes of LEF-LG patients undergoing TAVI is unknown. Of 606 consecutive patients undergoing TAVI, 113 (18.7%) patients with LEF-LG severe aortic stenosis (mean gradient ≤40 mm Hg, aortic valve area <1.0 cm(2), left ventricular ejection fraction <50%) were analyzed. LEF-LG patients were dichotomized into ≤mild MR (n=52) and ≥moderate MR (n=61). Primary end point was all-cause mortality at 1 year. No differences in mortality were observed at 30 days (P=0.76). At 1 year, LEF-LG patients with ≥moderate MR had an adjusted 3-fold higher rate of all-cause mortality (11.5% versus 38.1%; adjusted hazard ratio, 3.27 [95% confidence interval, 1.31-8.15]; P=0.011), as compared with LEF-LG patients with ≤mild MR. Mortality was mainly driven by cardiac death (adjusted hazard ratio, 4.62; P=0.005). As compared with LEF-LG patients with ≥moderate MR assigned to medical therapy, LEF-LG patients with ≥moderate MR undergoing TAVI had significantly lower all-cause mortality (hazard ratio, 0.38; 95% confidence interval, 0.019-0.75) at 1 year. Moderate or severe MR is a strong independent predictor of late mortality in LEF-LG patients undergoing TAVI. However, LEF-LG patients assigned to medical therapy have a dismal prognosis independent of MR severity suggesting that TAVI should not be withheld from symptomatic patients with LEF-LG severe aortic stenosis even in the presence of moderate or severe MR. © 2015 American Heart Association, Inc.

Cardiac rehabilitation and mid-term follow-up after transcatheter aortic valve implantation

PubMed Central

Zanettini, Renzo; Gatto, Gemma; Mori, Ileana; Pozzoni, Maria Beatrice; Pelenghi, Stefano; Martinelli, Luigi; Klugmann, Silvio

2014-01-01

Background Evaluation of patient outcomes following transcatheter aortic valve implantation (TAVI) has usually been based on survival and clinical improvement. Studies on quality of life are limited, and data from comprehensive assessments after the procedure are lacking. Methods Sixty patients referred for cardiac rehabilitation after TAVI underwent in-hospital and after-discharge multidimensional assessments to evaluate clinical, functional, and nutritional statuses, degree of autonomy, cognitive impairment, depression and quality of life. Results On admission to rehabilitation, approximately half of the patients had severe functional impairment and dependence for basic activities of daily living. During their hospital stay, one-third of the patients suffered significant clinical complications and two had to be transferred to the implantation center. Despite this, the overall outcome was very good. All of the remaining patients were clinically stable at discharge and functional status, autonomy and quality of life were improved in most. During a mean follow-up of 540 days (range: 192–738 days), five patients died from noncardiac causes, three were hospitalized for cardiac events, and nine for non cardiac reasons. Functional status and autonomy remained satisfactory in the majority of patients and most continued to live independently. Conclusions Patients referred for rehabilitation after TAVI are often very frail, with a high grade of functional impairment, dependence on others and high risk of clinical complications. During a rehabilitation programme, based on a multidimensional assessment and intervention, most patients showed significant improvement in functional status, quality of life, and autonomy, which remained stable in the majority of subjects during mid-term follow-up. PMID:25593575

Aorta calcification burden: Towards an integrative predictor of cardiac outcome after transcatheter aortic valve implantation.

PubMed

Harbaoui, Brahim; Montoy, Mathieu; Charles, Paul; Boussel, Loic; Liebgott, Hervé; Girerd, Nicolas; Courand, Pierre-Yves; Lantelme, Pierre

2016-03-01

The principal objective was to determine the effect of total aortic calcification (TAC) burden on outcomes (cardiac mortality, all-cause mortality, and heart failure (HF)) after transcatheter aortic valve implantation (TAVI). The secondary aim was to assess the contribution of each segment of the aorta to these outcomes. Indications for TAVI are increasing in number. Even after procedural success, however, some patients die soon afterwards, indicating the futility of TAVI in certain cases. Aortic calcifications were measured on computed tomography in 164 patients treated by TAVI. TAC, ascending aortic calcification (AsAC), descending aorta calcifications, and abdominal aorta calcifications were expressed as tertiles and their prognostic values were assessed in a multivariable cox analysis adjusted for major confounders including EuroSCORE. Median duration of follow-up was 565 (interquartile range: 246 to 1000) days. TAC (tertile3 vs. tertile1) was significantly and strongly associated with cardiac mortality (hazard ratio [HR]: 16.74; 95% confidence interval [CI]: 2.21 to 127.05; p = 0.006) and all-cause mortality (HR: 2.39; 95% CI: 1.18 to 4.84; p = 0.015) but not with HF (HR: 1.84; 95% CI: 0.87 to 3.90; p = 0.110). Each segment was associated with cardiac mortality, while only AsAC (tertile 3 vs. tertile 1) appeared predictive of HF (hazard ratio: 2.29; 95% CI: 1.12 to 4.66; p = 0.023). TAC is an integrative predictor of cardiac and all-cause mortality after TAVI. It should be included in the assessment of patients before TAVI in order to predict cardiac outcome after valve replacement and avoid futile interventions. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Transcatheter Aortic Valve Replacement Improves Health Status in Elderly Veterans.

PubMed

Gurevich, Sergey; Reiff, Chris; Bertog, Stefan; Mbai, Mackenzie; Kelly, Rosemary F; Soule, Matthew; Yannopoulos, Demetris; Garcia, Santiago

2018-06-01

United States veterans have substantially worse baseline health status than the general population, which may limit the health benefits of transcatheter aortic valve replacement (TAVR). The aim of this study is to quantify the health benefits of TAVR in veterans undergoing the procedure within the United States Department of Veterans Affairs (VA) health-care system. We prospectively evaluated heath status in 131 elderly veterans undergoing TAVR in the VA healthcare system between 2015 and 2017. Health status was assessed at baseline and 30 days post procedure using the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12). Totals and domain-specific (physical limitation, symptoms, quality of life, and social limitation) health statuses were measured and analyzed with a paired t-test. We also conducted stratified analysis by baseline New York Heart Association functional class and N-terminal pro-b type natriuretic peptide levels. Mean patient age was 77 ± 8 years and average Society of Thoracic Surgeons (STS) score was 4.4 (interquartile range, 3-7). Transfemoral access and balloon-expandable valves were used in 118 cases (92%) and 108 cases (83%), respectively. At baseline, overall health status was poor (overall score, 43 ± 19). After TAVR, significant improvements in overall health status (30 ± 18) and domain-specific health status were seen (improvements in physical limitation, 12 ± 20; symptoms, 23 ± 23; quality of life, 20 ± 17; social limitation, 22 ± 21; all P<.001). The majority of patients (88%) had moderate to large improvements in health status. A favorable outcome (alive with KCCQ-12 overall score >60 at 30 days) was seen in 78% of patients. Among elderly veterans with severe aortic stenosis, TAVR is associated with significant improvements in short-term health status.

Transapical aortic valve implantation and minimally invasive off-pump bypass surgery

PubMed Central

Ahad, Samir; Baumbach, Hardy; Hill, Stephan; Franke, Ulrich F. W.

2014-01-01

Transcatheter aortic valve implantation (TAVI) has gained increasing popularity for high-risk patients with symptomatic aortic valve stenosis. A concomitant coronary artery disease leads to a complicated management and an increased perioperative risk. This case report describes the successful total arterial coronary revascularization of the left anterior descending and the left marginal branch of the circumflex artery utilizing the left internal mammary artery (LIMA) and left radial artery in off-pump technique in combination with the transapical transcatheter aortic valve implantation via minimally invasive anterolateral access in the fifth intercostal space. PMID:24221960

Transcatheter aortic valve implantation using anatomically oriented, marrow stromal cell-based, stented, tissue-engineered heart valves: technical considerations and implications for translational cell-based heart valve concepts.

PubMed

Emmert, Maximilian Y; Weber, Benedikt; Behr, Luc; Sammut, Sebastien; Frauenfelder, Thomas; Wolint, Petra; Scherman, Jacques; Bettex, Dominique; Grünenfelder, Jürg; Falk, Volkmar; Hoerstrup, Simon P

2014-01-01

While transcatheter aortic valve implantation (TAVI) has rapidly evolved for the treatment of aortic valve disease, the currently used bioprostheses are prone to continuous calcific degeneration. Thus, autologous, cell-based, living, tissue-engineered heart valves (TEHVs) with regeneration potential have been suggested to overcome these limitations. We investigate the technical feasibility of combining the concept of TEHV with transapical implantation technology using a state-of-the-art transcatheter delivery system facilitating the exact anatomical position in the systemic circulation. Trileaflet TEHVs fabricated from biodegradable synthetic scaffolds were sewn onto self-expanding Nitinol stents seeded with autologous marrow stromal cells, crimped and transapically delivered into the orthotopic aortic valve position of adult sheep (n = 4) using the JenaValve transapical TAVI System (JenaValve, Munich, Germany). Delivery, positioning and functionality were assessed by angiography and echocardiography before the TEHV underwent post-mortem gross examination. For three-dimensional reconstruction of the stent position of the anatomically oriented system, a computed tomography analysis was performed post-mortem. Anatomically oriented, transapical delivery of marrow stromal cell-based TEHV into the orthotopic aortic valve position was successful in all animals (n = 4), with a duration from cell harvest to TEHV implantation of 101 ± 6 min. Fluoroscopy and echocardiography displayed sufficient positioning, thereby entirely excluding the native leaflets. There were no signs of coronary obstruction. All TEHV tolerated the loading pressure of the systemic circulation and no acute ruptures occurred. Animals displayed intact and mobile leaflets with an adequate functionality. The mean transvalvular gradient was 7.8 ± 0.9 mmHg, and the mean effective orifice area was 1.73 ± 0.02 cm(2). Paravalvular leakage was present in two animals, and central aortic regurgitation due to a

Single-center experience and short-term outcome with the JenaValve: a second-generation transapical transcatheter aortic valve implantation device.

PubMed

Reuthebuch, Oliver; Inderbitzin, Devdas Thomas; Rüter, Florian; Jeger, Raban; Kaiser, Christoph; Buser, Peter; Fassl, Jens; Eckstein, Friedrich S

2014-01-01

We present the post-CE(Conformité Européenne)-mark single-center implantation experience and short-term outcome with the second-generation transapical JenaValve transcatheter aortic valve implantation system. Patients [N = 27; 9 women; mean (SD) age, 80.3 (5.5) years] were operated on between November 2011 and August 2012. Via a transapical approach, the valve was positioned, in some cases, repositioned, and finally implanted. All data were collected during the hospital stay. The implantation success rate was 100%; the mean (SD) operation time was 124.7 (43.2) minutes; and the size of the implanted prosthesis was 23 mm (n = 6), 25 mm (n = 14), and 27 mm (n = 7). The in-hospital major adverse cardiac and cerebrovascular events were as follows: intraoperative resuscitation with subsequent aortic rupture (n = 1), postoperative hemorrhage needing revision (n = 1), myocardial infarction (n = 1), atrioventricular block needing a definitive pacemaker (n = 1), new-onset renal failure needing hemodialysis (n = 1), and stroke (n = 1). The 30-day mortality was 11.1% (n = 3). The mean (SD) intensive care unit/total stay was 2.2 (1.7)/11.7 (7.9) days. Postoperative echocardiography [day 6.7 (4.8)] revealed residual paravalvular leakage of trace to grade 1 in 12 patients (44.5%) and no leakage in 15 patients, with a mean (SD) transvalvular pressure gradient of 11.6 (5.6) mm Hg with significant reduction by 36.0 (17.7) mm Hg (P = 0.0001, Wilcoxon signed rank test). This second-generation repositionable transcatheter aortic valve implantation device could safely and successfully be implanted with a fast learning curve, significant reduction in pressure gradients, overall clinical improvement at discharge, as well as an acceptable morbidity and mortality rate in this highest-risk patient cohort.

Prevalence and Outcomes of Mitral Stenosis in Patients Undergoing Transcatheter Aortic Valve Replacement: Findings From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry.

PubMed

Joseph, Lee; Bashir, Mohammad; Xiang, Qun; Yerokun, Babatunde A; Matsouaka, Roland Albert; Vemulapalli, Sreekanth; Kapadia, Samir; Cigarroa, Joaquin E; Zahr, Firas

2018-04-09

This study sought to examine the prevalence of mitral stenosis (MS) and its impact on in-hospital and 1-year clinical outcomes among patients undergoing transcatheter aortic valve replacement (TAVR). Patients with coexisting severe aortic stenosis and MS are increasingly being considered for TAVR. The study cohort included 44,755 patients (age ≥18 years) who underwent TAVR during November 1, 2011, to September 30, 2015, and were registered in Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies (TVT) Registry. One-year outcomes were assessed by linking TVT registry data of this cohort to patient-specific Centers for Medicare & Medicaid Services administrative claims data (n = 31,453). The primary outcome was the composite of death, stroke, heart failure-related hospitalization, and mitral valve intervention at 1 year. MS was present in 11.6% of cohort (mean age, 82 years; 52% males), being severe in 2.7%. Severe MS was associated with higher in-hospital mortality rates (5.6% vs. 3.9% for nonsevere MS and 4.1% for no MS; p = 0.02). In contrast to those without MS, severe MS group had significantly higher risk for the primary outcome, mortality (1 year), and heart failure-related hospitalization (1 year) (adjusted hazard ratio: 1.2 [95% confidence interval (CI): 1.1 to 1.4], 1.2 [95% CI: 1.0 to 1.4], and 1.3 [95% CI: 1.1 to 1.5], respectively; p < 0.05 for all). Approximately one-tenth of patients undergoing TAVR have concomitant MS. Severe MS is an independent predictor of 1-year adverse clinical outcomes following TAVR. The higher risk for long-term adverse events must be considered when evaluating patients with combined aortic stenosis and MS for TAVR. Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Transcatheter Heart Valve Selection and Permanent Pacemaker Implantation in Patients With Pre-Existent Right Bundle Branch Block.

PubMed

van Gils, Lennart; Tchetche, Didier; Lhermusier, Thibault; Abawi, Masieh; Dumonteil, Nicolas; Rodriguez Olivares, Ramón; Molina-Martin de Nicolas, Javier; Stella, Pieter R; Carrié, Didier; De Jaegere, Peter P; Van Mieghem, Nicolas M

2017-03-03

Right bundle branch block is an established predictor for new conduction disturbances and need for a permanent pacemaker (PPM) after transcatheter aortic valve replacement. The aim of the study was to evaluate the absolute rates of transcatheter aortic valve replacement related PPM implantations in patients with pre-existent right bundle branch block and categorize for different transcatheter heart valves. We pooled data on 306 transcatheter aortic valve replacement patients from 4 high-volume centers in Europe and selected those with right bundle branch block at baseline without a previously implanted PPM. Logistic regression was used to evaluate whether PPM rate differed among transcatheter heart valves after adjustment for confounders. Mean age was 83±7 years and 63% were male. Median Society of Thoracic Surgeons score was 6.3 (interquartile range, 4.1-10.2). The following transcatheter valve designs were used: Medtronic CoreValve (n=130; Medtronic, Minneapolis, MN); Edwards Sapien XT (ES-XT; n=124) and Edwards Sapien 3 (ES-3; n=32; Edwards Lifesciences, Irvine, CA); and Boston Scientific Lotus (n=20; Boston Scientific Corporation, Marlborough, MA). Overall permanent pacemaker implantation rate post-transcatheter aortic valve replacement was 41%, and per valve design: 75% with Lotus, 46% with CoreValve, 32% with ES-XT, and 34% with ES-3. The indication for PPM implantation was total atrioventricular block in 98% of the cases. Lotus was associated with a higher PPM rate than all other valves. PPM rate did not differ between ES-XT and ES-3. Ventricular paced rhythm at 30-day and 1-year follow-up was present in 81% at 89%, respectively. Right bundle branch block at baseline is associated with a high incidence of PPM implantation for all transcatheter heart valves. PPM rate was highest for Lotus and lowest for ES-XT and ES-3. Pacemaker dependency remained high during follow-up. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by

Comparison of frequency, risk factors, and time course of postoperative delirium in octogenarians after transcatheter aortic valve implantation versus surgical aortic valve replacement.

PubMed

Eide, Leslie S P; Ranhoff, Anette H; Fridlund, Bengt; Haaverstad, Rune; Hufthammer, Karl Ove; Kuiper, Karel K J; Nordrehaug, Jan Erik; Norekvål, Tone M

2015-03-15

Postoperative delirium (PD) after transcatheter aortic valve implantation (TAVI) remains to be explored. We sought to (1) determine the incidence of PD in octogenarians who underwent TAVI or surgical aortic valve replacement (SAVR), (2) identify its risk factors, and (3) describe possible differences in the onset and course of PD between treatment groups. A prospective cohort study of consecutive patients aged ≥80 years with severe aortic stenosis who underwent elective TAVI or SAVR (N = 143) was conducted. The incidence of PD was assessed for 5 days using the Confusion Assessment Method (CAM). Risk factors for PD were studied with logistic regression. Patients treated with TAVI were older (p ≤0.001), had lower cognitive scores (p = 0.007), and more co-morbidities (p = 0.003). Despite this, significantly fewer (p = 0.013) patients treated with TAVI (44%) experienced PD compared to patients treated with SAVR (66%). Undergoing SAVR (p = 0.02) and having lower cognitive function (p = 0.03) emerged as risk factors for PD, whereas gender, activities of daily living, frailty, atrial fibrillation, and postoperative use of opioids and anxiolytics did not. Patients treated with TAVI and without PD during the first 2 postoperative days were unlikely to experience PD on subsequent days. The onset of PD after SAVR could occur at any time during the postoperative evaluation. In conclusion, SAVR in octogenarian patients with aortic stenosis might be considered as a predisposing factor for PD. Our data also suggest that the onset of PD was more unpredictable after SAVR. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Incidence, Causes, and Impact of In-Hospital Infections After Transcatheter Aortic Valve Implantation.

PubMed

Tirado-Conte, Gabriela; Freitas-Ferraz, Afonso B; Nombela-Franco, Luis; Jimenez-Quevedo, Pilar; Biagioni, Corina; Cuadrado, Ana; Nuñez-Gil, Ivan; Salinas, Pablo; Gonzalo, Nieves; Ferrera, Carlos; Vivas, David; Higueras, Javier; Viana-Tejedor, Ana; Perez-Vizcayno, Maria Jose; Vilacosta, Isidre; Escaned, Javier; Fernandez-Ortiz, Antonio; Macaya, Carlos

2016-08-01

In-hospital infections (IHI) are one of the most common and serious problems after invasive procedures. Transcatheter aortic valve implantation (TAVI) is an increasingly used alternative to surgery in patients with severe symptomatic aortic stenosis. The aim of this study was to determine the incidence, origin, risk factors, and clinical outcomes of IHI after TAVI. A total of 303 consecutive patients with severe aortic stenosis who underwent transfemoral TAVI were included and followed during a median time of 21 months. We examined the occurrence, types, origin, and timing of infections during hospital stay as well as short- and long-term clinical outcomes according to the occurrence of IHI. A total of 51 patients (17%; 62 infectious episodes) experienced IHI after TAVI. Respiratory and urinary tract infections were the most frequent type of infections (44% and 34%, respectively), followed by surgical site infection (8%) and bloodstream infection (5%). Positive cultures were obtained in 74% of the samples, of which 65% were gram-negative bacilli. Modifiable factors such as bleeding (p = 0.005) and length of coronary care unit stay (p <0.001) were independently associated with an increased infection risk. Patients with IHI had a longer hospital stay (14 vs 6 days, p <0.001), an increased mortality (hazard ratio 2.48, 95% CI 1.45 to 4.23) and readmission rate (hazard ratio 2.0, 95% CI 1.27 to 3.14) during the follow-up. In conclusion, IHI is a frequent complication after TAVI with a significant impact on short- and long-term clinical outcomes. The most important risk factors associated with the development of this complication were modifiable periprocedural aspects. These results underline the importance to implement specific preventive strategies to reduce in-hospital-acquired infections after TAVI. Copyright © 2016 Elsevier Inc. All rights reserved.

Association of body mass index and visceral fat with aortic valve calcification and mortality after transcatheter aortic valve replacement: the obesity paradox in severe aortic stenosis.

PubMed

Mancio, Jennifer; Fonseca, Paulo; Figueiredo, Bruno; Ferreira, Wilson; Carvalho, Monica; Ferreira, Nuno; Braga, Pedro; Rodrigues, Alberto; Barros, Antonio; Falcao-Pires, Ines; Leite-Moreira, Adelino; Ribeiro, Vasco Gama; Bettencourt, Nuno

2017-01-01

Previous studies showed that metabolic syndrome is associated with aortic valve calcification (AVC) and poor outcomes in aortic stenosis (AS). However, if these associations change and how body fat impacts the prognosis of patients in late stage of the disease have been not yet explored. To determine the association of body mass index (BMI) and visceral fat with AVC and mortality after transcatheter aortic valve replacement (TAVR). This was a prospective cohort of 170 severe AS patients referred to TAVR. We quantified AVC mass score and fat depots including epicardial adipose tissue, intrathoracic fat, and abdominal visceral (VAF) and subcutaneous fats by computed tomography. Fat depots were indexed to body surface area. All-cause and cardiovascular-related deaths after TAVR were recorded over a median follow-up of 1.2 years. Higher AVC mass was independently associated with low BMI and low VAF. All-cause mortality risk increased with the decrease of BMI and increment of VAF. A stratified analysis by obesity showed that in non-obese, VAF was inversely associated with mortality, whereas in obese, high VAF was associated with higher mortality (p value for interaction < 0.05). At long-term, hazard ratio [HR] with non-obese/low VAF was 2.3 (95% confidence interval [CI] 1.1-4.9; p = 0.021) and HR with obese/high VAF was 2.5 (95% CI 1.1-5.8; p = 0.031) compared with obese/low VAF patients. In AS patients submitted to TAVR, BMI and VAF were inversely associated with AVC. Pre-intervention assessment of VAF by computed tomography may provide a better discrimination of mortality than BMI alone.

Usefulness of Urine Output Criteria for Early Detection of Acute Kidney Injury after Transcatheter Aortic Valve Implantation

PubMed Central

Shacham, Yacov; Rofe, Maytal; Leshem-Rubinow, Eran; Gal-Oz, Amir; Arbel, Yaron; Keren, Gad; Roth, Arie; Ben-Assa, Eyal; Halkin, Amir; Finkelstein, Ariel; Banai, Shmuel; Steinvil, Arie

2014-01-01

Background Previous studies demonstrated that acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI) is frequent and associated with adverse outcomes. However, these studies only applied the serum creatinine (sCr) criteria while ignoring the urine output criteria. We hypothesized that adding the urine output criteria might contribute to an earlier diagnosis of AKI. Methods We included 143 patients with severe aortic stenosis who underwent transfemoral TAVI between December 2012 and April 2014. Urine output was assessed hourly for at least 24 h following TAVI, and sCr was assessed at least daily until discharge. Based on the Valve Academic Research Consortium-2 (VARC-2), AKI was determined using both sCr and urine output criteria. We compared the incidence of AKI and time to AKI diagnosis based on these two methods. Results The mean age was 81 ± 6 years (range 61-94) and 56% were male. AKI occurred in 27 (19%) patients, 13 (9%) of whom had AKI defined by sCr criteria. Twenty (14%) patients had AKI defined by urine output criteria, only 6 of whom had AKI also defined by sCr criteria. The use of urine output criteria resulted in earlier identification of AKI (18 ± 4 vs. 64 ± 57 h, p = 0.02) and was associated with lower sCr elevation in patients having AKI defined by only urine output criteria (0.03 ± 0.12 vs. 0.37 ± 0.06 mg/dl, p < 0.001). Conclusion The use of the VARC-2 urine output criteria significantly increased the incidence of AKI and shortened the time to AKI diagnosis. PMID:25737679

Transcatheter aortic valve replacement in patients with severe mitral or tricuspid regurgitation at extreme risk for surgery.

PubMed

Little, Stephen H; Popma, Jeffrey J; Kleiman, Neal S; Deeb, G Michael; Gleason, Thomas G; Yakubov, Steven J; Checuti, Stan; O'Hair, Daniel; Bajwa, Tanvir; Mumtaz, Mubashir; Maini, Brijeshwar; Hartman, Alan; Katz, Stanley; Robinson, Newell; Petrossian, George; Heiser, John; Merhi, William; Moore, B Jane; Li, Shuzhen; Adams, David H; Reardon, Michael J

2018-05-01

Patients with symptomatic severe aortic stenosis and severe mitral regurgitation or severe tricuspid regurgitation were excluded from the major transcatheter aortic valve replacement trials. We studied these 2 subgroups in patients at extreme risk for surgery in the prospective, nonrandomized, single-arm CoreValve US Expanded Use Study. The primary end point was all-cause mortality or major stroke at 1 year. A favorable medical benefit was defined as a Kansas City Cardiomyopathy Questionnaire overall summary score greater than 45 at 6 months and greater than 60 at 1 year and with a less than 10-point decrease from baseline. There were 53 patients in each group. Baseline characteristics for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were age 84.2 ± 6.4 years and 84.9 ± 6.5 years; male, 29 (54.7%) and 22 (41.5%), and mean Society of Thoracic Surgeons score 9.9% ± 5.0% and 9.2% ± 4.0%, respectively. Improvement in valve regurgitation from baseline to 1 year occurred in 72.7% of the patients with severe mitral regurgitation and in 61.8% of patients with severe tricuspid regurgitation. A favorable medical benefit occurred in 31 of 47 patients (66.0%) with severe mitral regurgitation and 33 of 47 patients (70.2%) with severe tricuspid regurgitation at 6 months, and in 25 of 44 patients (56.8%) with severe mitral regurgitation and 24 of 45 patients (53.3%) with severe tricuspid regurgitation at 1 year. All-cause mortality or major stroke for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were 11.3% and 3.8% at 30 days and 21.0% and 19.2% at 1 year, respectively. There were no major strokes in either group at 1 year. Transcatheter aortic valve replacement in patients with severe mitral regurgitation or severe tricuspid regurgitation is reasonable and safe and leads to improvement in atrioventricular valve regurgitation. Copyright © 2018 The American Association for Thoracic Surgery

Relation Between Six-Minute Walk Test Performance and Outcomes After Transcatheter Aortic Valve Implantation (from the PARTNER Trial)

PubMed Central

Green, Philip; Cohen, David J.; Généreux, Philippe; McAndrew, Tom; Arnold, Suzanne V.; Alu, Maria; Beohar, Nirat; Rihal, Charanjit S.; Mack, Michael J.; Kapadia, Samir; Dvir, Danny; Maurer, Mathew S.; Williams, Mathew R.; Kodali, Susheel; Leon, Martin B.; Kirtane, Ajay J.

2013-01-01

Functional capacity as assessed by 6-minute walk test distance (6MWTD) has been shown to predict outcomes in selected cohorts with cardiovascular disease. To evaluate the association between 6MWTD and outcomes after transcatheter aortic valve implantation (TAVI) among participants in the Placement of AoRTic TraNscathetER valve (PARTNER) trial, TAVI recipients (n = 484) were stratified into 3 groups according to baseline 6MWTD: unable to walk (n = 218), slow walkers (n = 133), in whom 6MWTD was below the median (128.5 meters), and fast walkers (n = 133) with 6MWTD >128.5 meters. After TAVI, among fast walkers, follow-up 6MWTD decreased by 44 ± 148 meters at 12 months (p <0.02 compared with baseline). In contrast, among slow walkers, 6MWTD improved after TAVI by 58 ± 126 meters (p <0.001 compared with baseline). Similarly, among those unable to walk, 6MWTD distance increased by 66 ± 109 meters (p <0.001 compared with baseline). There were no differences in 30-day outcomes among 6MWTD groups. At 2 years, the rate of death from any cause was 42.5% in those unable to walk, 31.2% in slow walkers, and 28.8% in fast walkers (p = 0.02), driven primarily by differences in noncardiac death. In conclusion, among high-risk older adults undergoing TAVI, baseline 6MWTD does not predict procedural outcomes but does predict long-term mortality. Nonetheless, patients with poor baseline functional status exhibit the greatest improvement in 6MWTD. Additional work is required to identify those with poor functional status who stand to benefit the most from TAVI. PMID:23725996

Feasibility and outcomes of combined transcatheter aortic valve replacement with other structural heart interventions in a single session: a matched cohort study

PubMed Central

Khattab, Ahmed A; Gloekler, Steffen; Sprecher, Beate; Shakir, Samera; Guerios, Ênio; Stortecky, Stefan; O'Sullivan, Crochan J; Nietlispach, Fabian; Moschovitis, Aris; Pilgrim, Thomas; Buellesfeld, Lutz; Wenaweser, Peter; Windecker, Stephan; Meier, Bernhard

2014-01-01

Background Concurrent cardiac diseases are frequent among elderly patients and invite simultaneous treatment to ensure an overall favourable patient outcome. Aim To investigate the feasibility of combined single-session percutaneous cardiac interventions in the era of transcatheter aortic valve implantation (TAVI). Methods This prospective, case–control study included 10 consecutive patients treated with TAVI, left atrial appendage occlusion and percutaneous coronary interventions. Some in addition had patent foramen ovale or atrial septal defect closure in the same session. The patients were matched in a 1:10 manner with TAVI-only cases treated within the same time period at the same institution regarding their baseline factors. The outcome was validated according to the Valve Academic Research Consortium (VARC) criteria. Results Procedural time (126±42 vs 83±40 min, p=0.0016), radiation time (34±8 vs 22±12 min, p=0.0001) and contrast dye (397±89 vs 250±105 mL, p<0.0001) were higher in the combined intervention group than in the TAVI-only group. Despite these drawbacks, no difference in the VARC endpoints was evident during the in-hospital period and after 30 days (VARC combined safety endpoint 32% for TAVI only and 20% for combined intervention, p=1.0). Conclusions Transcatheter treatment of combined cardiac diseases is feasible even in a single session in a high-volume centre with experienced operators. PMID:25332781

The Economics of Transcatheter Valve Interventions.

PubMed

Sud, Maneesh; Tam, Derrick Y; Wijeysundera, Harindra C

2017-09-01

A subset of patients who require correction of a stenotic or incompetent valve are deemed to be at excessive surgical risk, which precludes surgical repair or replacement. Transcatheter valve interventions are viable alternatives in these patients. However, these technologies are costly, and in the setting of a constrained Canadian health care budget, economic value is an important consideration to allow for fair allocation of scarce resources. Accordingly, we review the economic literature on transcatheter valve interventions, targeting a general audience. Our specific goals are highlighting how best to interpret these studies and discuss the implications of these technologies on the Canadian health care system. Transcatheter aortic valve replacement (TAVR) is a cost-effective alternative for inoperable patients who otherwise would receive medical therapy. When compared with surgical aortic valve replacement (SAVR), TAVR is associated with significant reductions in postprocedure hospital resource use, which offsets the substantially higher cost of the TAVR valve system relative to SAVR valves. Although cost-effectiveness estimates for TAVR in high-risk operable candidates vary widely across studies, based on contemporary data from the perspective of the Canadian health care system, TAVR is likely to provide economic value. Recent studies suggest that when compared with medical therapy for severe degenerative mitral regurgitation, the MitraClip (Abbott, Abbott Park, IL) may offer economic value in high-risk patients; however, in the absence of randomized controlled trials, this is speculative. Nonetheless, these transcatheter technologies represent a paradigm shift in the management of valvular disease; their dissemination will have substantial impact in cardiovascular care delivery. Copyright © 2017 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Balloon aortic valvuloplasty as a bridge-to-decision in high risk patients with aortic stenosis: a new paradigm for the heart team decision making

PubMed Central

Saia, Francesco; Moretti, Carolina; Dall'Ara, Gianni; Ciuca, Cristina; Taglieri, Nevio; Berardini, Alessandra; Gallo, Pamela; Cannizzo, Marina; Chiarabelli, Matteo; Ramponi, Niccolò; Taffani, Linda; Bacchi-Reggiani, Maria Letizia; Marrozzini, Cinzia; Rapezzi, Claudio; Marzocchi, Antonio

2016-01-01

Background Whilst the majority of the patients with severe aortic stenosis can be directly addressed to surgical aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI), in some instances additional information may be needed to complete the diagnostic workout. We evaluated the role of balloon aortic valvuloplasty (BAV) as a bridge-to-decision (BTD) in selected high-risk patients. Methods Between 2007 and 2012, the heart team in our Institution required BTD BAV in 202 patients. Very low left ventricular ejection fraction, mitral regurgitation grade ≥ 3, frailty, hemodynamic instability, serious comorbidity, or a combination of these factors were the main drivers for this strategy. We evaluated how BAV influenced the final treatment strategy in the whole patient group and in each specific subgroup. Results Mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) was 23.5% ± 15.3%, age 81 ± 7 years. In-hospital mortality was 4.5%, cerebrovascular accident 1% and overall vascular complications 4% (0.5% major; 3.5% minor). Of the 193 patients with BTD BAV who survived and received a second heart team evaluation, 72.6% were finally deemed eligible for definitive treatment (25.4% for AVR; 47.2% for TAVI): 96.7% of patients with left ventricular ejection fraction recovery; 70.5% of patients with mitral regurgitation reduction; 75.7% of patients who underwent BAV in clinical hemodynamic instability; 69.2% of frail patients and 68% of patients who presented serious comorbidities. Conclusions Balloon aortic valvuloplasty can be considered as bridge-to-decision in high-risk patients with severe aortic stenosis who cannot be immediate candidates for definitive transcatheter or surgical treatment. PMID:27582761

Basic Principles of Health Economics Applied - How to Assess if Transcatheter Aortic Valve Implantation is Worth the Investment.

PubMed

Brunn, Matthias; Durand-Zaleski, Isabelle

2013-08-01

This article attempts to present some highlights from the rich economic literature pertaining to interventional cardiology and transcatheter aortic valve implantation (TAVI). There are currently more questions than answers, not surprisingly given the pace of technological change in interventional cardiology. For clinicians who work in a strictly regulated environment and have limited control over their use of medical technologies, this article will hopefully shed some light on the motives for policy decisions. For clinicians who make decisions on the resources used to treat their patients, it aims to provide the means of looking for evidence that will allow for informed decisions from both clinical and economic perspectives.

The transcatheter aortic valve implementation (TAVI)--a qualitative approach to the implementation and diffusion of a minimally invasive surgical procedure.

PubMed

Merkel, Sebastian; Eikermann, Michaela; Neugebauer, Edmund A; von Bandemer, Stephan

2015-10-06

The transcatheter aortic valve implantation (TAVI), a minimally invasive surgical procedure to treat patients with severe symptomatic aortic stenosis, showed a rapid diffusion in Germany compared to the international level. The aim of this study is to identify and analyze factors affecting the implementation and diffusion of the procedure in hospitals using a qualitative application of the diffusion of innovations theory. We conducted problem-centered interviews with cardiologists and cardiac surgeons working in German hospitals. The multi-level model "diffusion of innovations in health services organizations" developed by Greenhalgh et al. was used to guide the research. Data was analyzed using content and a thematic analysis. Among the ten participants who were interviewed, we found both barriers and facilitators related to the innovation itself, system readiness and antecedents, communication and influence, and the outer context. Key issues were the collaboration between cardiologists and cardiac surgeons, reimbursement policies, requirements needed to conduct the procedure, and medical advantages of the method. The findings show that there are multiple factors influencing the diffusion of TAVI that go beyond the reimbursement and cost issues. The diffusion of innovations model proved to be helpful in understanding the different aspects of the uptake of the procedure. A central theme that affected the implementation of TAVI was the collaboration and competition between involved medical departments: cardiology and cardiac surgery. Against this background, it seems especially important to moderate and coordinate the cooperation of the different medical disciplines.

The utility of live video capture to enhance debriefing following transcatheter aortic valve replacement

PubMed Central

Seamans, David P.; Louka, Boshra F.; Fortuin, F. David; Patel, Bhavesh M.; Sweeney, John P.; Lanza, Louis A.; DeValeria, Patrick A.; Ezrre, Kim M.; Ramakrishna, Harish

2016-01-01

Background: The surgical and procedural specialties are continually evolving their methods to include more complex and technically difficult cases. These cases can be longer and incorporate multiple teams in a different model of operating room synergy. Patients are frequently older, with comorbidities adding to the complexity of these cases. Recording of this environment has become more feasible recently with advancement in video and audio capture systems often used in the simulation realm. Aims: We began using live capture to record a new procedure shortly after starting these cases in our institution. This has provided continued assessment and evaluation of live procedures. The goal of this was to improve human factors and situational challenges by review and debriefing. Setting and Design: B-Line Medical's LiveCapture video system was used to record successive transcatheter aortic valve replacement (TAVR) procedures in our cardiac catheterization/laboratory. An illustrative case is used to discuss analysis and debriefing of the case using this system. Results and Conclusions: An illustrative case is presented that resulted in long-term changes to our approach of these cases. The video capture documented rare events during one of our TAVR procedures. Analysis and debriefing led to definitive changes in our practice. While there are hurdles to the use of this technology in every institution, the role for the ongoing use of video capture, analysis, and debriefing may play an important role in the future of patient safety and human factors analysis in the operating environment. PMID:27762242

Three-dimensional thoracic aorta principal strain analysis from routine ECG-gated computerized tomography: feasibility in patients undergoing transcatheter aortic valve replacement.

PubMed

Satriano, Alessandro; Guenther, Zachary; White, James A; Merchant, Naeem; Di Martino, Elena S; Al-Qoofi, Faisal; Lydell, Carmen P; Fine, Nowell M

2018-05-02

Functional impairment of the aorta is a recognized complication of aortic and aortic valve disease. Aortic strain measurement provides effective quantification of mechanical aortic function, and 3-dimenional (3D) approaches may be desirable for serial evaluation. Computerized tomographic angiography (CTA) is routinely performed for various clinical indications, and offers the unique potential to study 3D aortic deformation. We sought to investigate the feasibility of performing 3D aortic strain analysis in a candidate population of patients undergoing transcatheter aortic valve replacement (TAVR). Twenty-one patients with severe aortic valve stenosis (AS) referred for TAVR underwent ECG-gated CTA and echocardiography. CTA images were analyzed using a 3D feature-tracking based technique to construct a dynamic aortic mesh model to perform peak principal strain amplitude (PPSA) analysis. Segmental strain values were correlated against clinical, hemodynamic and echocardiographic variables. Reproducibility analysis was performed. The mean patient age was 81±6 years. Mean left ventricular ejection fraction was 52±14%, aortic valve area (AVA) 0.6±0.3 cm 2 and mean AS pressure gradient (MG) 44±11 mmHg. CTA-based 3D PPSA analysis was feasible in all subjects. Mean PPSA values for the global thoracic aorta, ascending aorta, aortic arch and descending aorta segments were 6.5±3.0, 10.2±6.0, 6.1±2.9 and 3.3±1.7%, respectively. 3D PSSA values demonstrated significantly more impairment with measures of worsening AS severity, including AVA and MG for the global thoracic aorta and ascending segment (p<0.001 for all). 3D PSSA was independently associated with AVA by multivariable modelling. Coefficients of variation for intra- and inter-observer variability were 5.8 and 7.2%, respectively. Three-dimensional aortic PPSA analysis is clinically feasible from routine ECG-gated CTA. Appropriate reductions in PSSA were identified with increasing AS hemodynamic severity. Expanded

Standardized methodology for transfemoral transcatheter aortic valve replacement with the Edwards Sapien XT valve under fluoroscopy guidance.

PubMed

Kasel, Albert M; Shivaraju, Anupama; Schneider, Stephan; Krapf, Stephan; Oertel, Frank; Burgdorf, Christof; Ott, Ilka; Sumer, Christian; Kastrati, Adnan; von Scheidt, Wolfgang; Thilo, Christian

2014-09-01

To provide a simplified, standardized methodology for a successful transfemoral transcatheter aortic valve replacement (TAVR) procedure with the Sapien XT valve in patients with severe aortic stenosis (AS). TAVR is currently reserved for patients with severe, symptomatic AS who are inoperable or at high operative risk. In many institutions, TAVR is performed under general anesthesia with intubation or with conscious sedation. In addition, many institutions still use transesophageal echo (TEE) during the procedure for aortic root angulations and positioning of the valve prior to implantation. Methods. We enrolled 100 consecutive patients (mean age, 80 ± 7 years; range, 50-94 years; female n=59) with severe symptomatic AS. Annulus measurements were based on computed tomography angiograms. All patients underwent fluoroscopy-guided transfemoral TAVR with little to no sedation and without simultaneous TEE. TAVR was predominantly performed with the use of local and central analgesics; only 36% of our cohort received conscious sedation. Procedural success of TAVR was 99%. Transthoracic echocardiography before discharge excluded aortic regurgitation (AR) >2 in all patients (AR >1; n=6). In-hospital stroke rate was 6%. The vessel closure system was successfully employed in 96%. Major vascular complication rate was 1%. The 30-day mortality was 2%. Fluoroscopy-guided TAVR with the use of just analgesics with or without conscious sedation is safe and effective, and this potentially enables a more time-effective and cost-effective procedure. This paper provides simplified, stepwise guidance on how to perform transfemoral TAVR with the Sapien XT valve.

Cerebrovascular accidents complicating transcatheter aortic valve implantation: frequency, timing and impact on outcomes.

PubMed

Stortecky, Stefan; Windecker, Stephan; Pilgrim, Thomas; Heg, Dik; Buellesfeld, Lutz; Khattab, Ahmed A; Huber, Christoph; Gloekler, Steffen; Nietlispach, Fabian; Mattle, Heinrich; Jüni, Peter; Wenaweser, Peter

2012-05-15

Cerebrovascular accidents (CVA) are considered among the most serious adverse events after transcatheter aortic valve implantation (TAVI). The objective of the present study was to evaluate the frequency and timing of CVA after TAVI and to investigate the impact on clinical outcomes within 30 days of the procedure. Between August 2007 and October 2011, 389 high-risk elderly patients with symptomatic severe aortic stenosis underwent TAVI via transfemoral, transapical or subclavian access. A total of 14 patients (3.6%) experienced at least one CVA within 30 days of follow-up and most events (74%) occurred within the first day of the procedure. Patients with CVA had an increased risk of all-cause (42.3% vs. 5.1%, ORadjusted 11.7, 95% CI 3.4-40.3, p<0.001) and cardiovascular mortality (38.4% vs. 4.6%, ORadjusted 10.5, 95% CI 2.9-37.8, p<0.001) compared to patients without CVA at 30 days of follow-up. Repeated device implantation attempts (ORadjusted 8.3, CI 2.1-33.3, p<0.003), chronic pulmonary disease (ORadjusted 4.7, CI 1.3-16.8, p=0.02) and body mass index <25 kg/m2 (ORadjusted 0.8, CI 0.7-0.9, p<0.01) emerged as independent predictors of periprocedural CVA. Cerebrovascular accidents among patients undergoing TAVI occur predominantly during the periprocedural period, are associated with multiple implantation attempts of the bioprosthesis and significantly impair prognosis.

Successful simultaneous ipsilateral stenting of common iliac artery stenosis and transfemoral aortic valve replacement.

PubMed

Aslan, Abdullah Nabi; Kasapkara, Hacı Ahmet; Sivri, Serkan; Güney, Murat Can; Bozkurt, Engin

2017-01-01

Transcatheter aortic valve replacement (TAVR) was designed to treat elderly patients with severe aortic stenosis at high risk for surgery, and is most commonly performed with retrograde approach through femoral arteries. However, in up to 30% of cases, it is either not possible to use this access route or it is considered to have high risk of vascular injury. Alternative approaches have been described for patients with no suitable femoral access: trans-subclavian, transaortic, or direct aortic access; however, since the introduction of new valves deployed with low-profile delivery systems, another alternative transcatheter approach has been discovered. Presently described is experience in 2 cases in which patients were treated with transfemoral TAVR using Edwards SAPIEN 3 transcatheter heart valves immediately following ipsilateral common iliac artery stenting.

Three-Year Outcomes of Transcatheter Aortic Valve Implantation in Patients With Varying Levels of Surgical Risk (from the CoreValve ADVANCE Study).

PubMed

Barbanti, Marco; Schiltgen, Molly; Verdoliva, Sarah; Bosmans, Johan; Bleiziffer, Sabine; Gerckens, Ulrich; Wenaweser, Peter; Brecker, Stephen; Gulino, Simona; Tamburino, Corrado; Linke, Axel

2016-03-01

This study compared 3-year clinical outcomes of patients who underwent transcatheter aortic valve implantation with the Society of Thoracic Surgeons (STS) score ≤7% to those of patients with a score >7%. Data were drawn from the ADVANCE study, a multinational post-market clinical trial that enrolled real-world patients with severe aortic stenosis treated with the CoreValve bioprosthesis. Events were independently adjudicated using Valve Academic Research Consortium-1 definitions. A total of 996 patients were implanted: STS ≤7% (n = 697, median STS 4.3%, interquartile range 3.1% to 5.4%) and STS >7% (n = 298, median STS 9.7%, interquartile range 8.0% to 12.4%). At 3 years, the STS ≤7% group had lower rates of all-cause mortality (28.6 vs 45.9, p <0.01) and cardiovascular mortality (19.0 vs 30.2, p <0.01) than the STS >7% group. No differences were observed in cerebrovascular accidents, vascular complications, bleeding, or myocardial infarction. In patients with STS ≤7%, mortality at 3 years was higher in those with moderate or severe aortic regurgitation (AR) at discharge than in those with mild or less AR (39.9% vs 22.9%; hazard ratio 1.98; 95% confidence interval 1.37 to 2.86; p <0.01). Conversely, the severity of AR at discharge did not affect 3-year mortality in patients with STS >7% (42.9% vs 44.6%, moderate/severe vs mild/less; hazard ratio 1.04; 95% confidence interval, 0.62 to 1.75; p = 0.861; p for interaction = 0.047). In conclusion, patients with STS ≤7% had lower rates of all-cause and cardiovascular mortality at 3 years after transcatheter aortic valve implantation. Complication rates were low and stable in both groups, demonstrating the safety of this procedure for patients at various levels of surgical risk. Copyright © 2016 Elsevier Inc. All rights reserved.

Quantity and location of aortic valve complex calcification predicts severity and location of paravalvular regurgitation and frequency of post-dilation after balloon-expandable transcatheter aortic valve replacement.

PubMed

Khalique, Omar K; Hahn, Rebecca T; Gada, Hemal; Nazif, Tamim M; Vahl, Torsten P; George, Isaac; Kalesan, Bindu; Forster, Molly; Williams, Mathew B; Leon, Martin B; Einstein, Andrew J; Pulerwitz, Todd C; Pearson, Gregory D N; Kodali, Susheel K

2014-08-01

This study sought to determine the impact of quantity and location of aortic valve calcification (AVC) on paravalvular regurgitation (PVR) and rates of post-dilation (PD) immediately after transcatheter aortic valve replacement (TAVR). The impact of AVC in different locations within the aortic valve complex is incompletely understood. This study analyzed 150 patients with severe, symptomatic aortic stenosis who underwent TAVR. Total AVC volume scores were calculated from contrast-enhanced multidetector row computed tomography imaging. AVC was divided by leaflet sector and region (Leaflet, Annulus, left ventricular outflow tract [LVOT]), and a combination of LVOT and Annulus (AnnulusLVOT). Asymmetry was assessed. Receiver-operating characteristic analysis was performed with greater than or equal to mild PVR and PD as classification variables. Logistic regression was performed. Quantity of and asymmetry of AVC for all regions of the aortic valve complex predicted greater than or equal to mild PVR by receiver-operating characteristic analysis (area under the curve = 0.635 to 0.689), except Leaflet asymmetry. Receiver-operating characteristic analysis for PD was significant for quantity and asymmetry of AVC in all regions, with higher area under the curve values than for PVR (area under the curve = 0.648 to 0.741). On multivariable analysis, Leaflet and AnnulusLVOT calcification were independent predictors of both PVR and PD regardless of multidetector row computed tomography area cover index. Quantity and asymmetry of AVC in all regions of the aortic valve complex predict greater than or equal to mild PVR and performance of PD, with the exception of Leaflet asymmetry. Quantity of AnnulusLVOT and Leaflet calcification independently predict PVR and PD when taking into account multidetector row computed tomography area cover index. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Risk stratification using lean body mass in patients undergoing transcatheter aortic valve replacement.

PubMed

Hioki, Hirofumi; Watanabe, Yusuke; Kozuma, Ken; Yamamoto, Masanori; Naganuma, Toru; Araki, Motoharu; Tada, Norio; Shirai, Shinichi; Yamanaka, Futoshi; Higashimori, Akihiro; Mizutani, Kazuki; Tabata, Minoru; Takagi, Kensuke; Ueno, Hiroshi; Hayashida, Kentaro

2018-02-22

The prognostic impact of skeletal muscle mass, assessed using lean body mass (LBM), remain unclear in patients who underwent transcatheter aortic valve replacement (TAVR). The aim of this study to assess prognostic impact of LBM on mortality after TAVR. We assessed 1,613 patients (median age 85 years, 70% female) who underwent TAVI from October 2013 to April 2016 using OCEAN (Optimized transCathEter vAlvular interveNtion)-TAVI registry data. LBM was calculated using the James formula. The primary endpoint was all-cause death after TAVR. Median follow-up period was 287 days (interquartile range 110-462). The Kaplan-Meier analysis demonstrated that patients with low LBM had significantly higher incidence of all-cause death than those with high LBM in male (32.3% vs. 9.9%, log rank P < 0.001) and female (15.8% vs. 9.2%, log-rank P = 0.011). On contrary, the risk stratification using body mass index (BMI) could not validate into female patients who underwent TAVR. The multivariate analysis showed that the LBM was an independent predictor of all-cause death in male (Hazard ratio [HR] 0.93; 95% confidence interval [CI] 0.89-0.98) and female (HR 0.94; 95% CI 0.89-0.99). Inversely, the assessment using BMI could not identify the high-risk population in a female. The patients with low LBM had the higher incidence of all-cause death after TAVR than those with high LBM, regardless of gender. Thus, the risk stratification using LBM might provide further insight to identify the high-risk TAVR population, compared to conventional risk stratification using BMI. © 2018 Wiley Periodicals, Inc.

Costs of Peri-Procedural Complications in Patients Treated with Transcatheter Aortic Valve Replacement: Results from the PARTNER Trial

PubMed Central

Arnold, Suzanne V.; Lei, Yang; Reynolds, Matthew R.; Magnuson, Elizabeth A.; Suri, Rakesh M.; Tuzcu, E. Murat; Petersen, John L.; Douglas, Pamela S.; Svensson, Lars G.; Gada, Hemal; Thourani, Vinod H.; Kodali, Susheel K.; Mack, Michael J.; Leon, Martin B.; Cohen, David J.

2014-01-01

Background In patients with severe aortic stenosis, transcatheter aortic valve replacement (TAVR) improves survival compared with nonsurgical therapy but with higher in-hospital and lifetime costs. Complications associated with TAVR may decrease with greater experience and improved devices, thereby reducing the overall cost of the procedure. Therefore, we sought to estimate the impact of peri-procedural complications on in-hospital costs and length of stay of TAVR. Methods and Results Using detailed cost data from 406 TAVR patients enrolled in the PARTNER I trial, we developed multivariable models to estimate the incremental cost and length of stay associated with specific peri-procedural complications. Attributable costs and length of stay for each complication were calculated by multiplying the independent cost of each event by its frequency in the treatment group. Mean cost for the initial hospitalization was $79,619 ± 40,570 ($50,891 excluding the valve); 49% of patients had ≥1 complication. Seven complications were independently associated with increased hospital costs, with major bleeding, arrhythmia and death accounting for the largest attributable cost per patient. Renal failure and the need for repeat TAVR, although less frequent, were also associated with substantial incremental and attributable costs. Overall, complications accounted for $12,475/patient in initial hospital costs and 2.4 days of hospitalization. Conclusion In the PARTNER trial, peri-procedural complications were frequent, costly, and accounted for approximately 25% of non-implant related hospital costs. Avoidance of complications should improve the cost-effectiveness of TAVR for inoperable and high-risk patients, but reductions in the cost of uncomplicated TAVR will also be necessary for optimal efficiency. PMID:25336467

Introduction of an interdisciplinary heart team-based transcatheter aortic valve implantation programme: short and mid-term outcomes.

PubMed

Martínez, G J; Seco, M; Jaijee, S K; Adams, M R; Cartwright, B L; Forrest, P; Celermajer, D S; Vallely, M P; Wilson, M K; Ng, M K C

2014-09-01

Transcatheter aortic valve implantation (TAVI) has been developed to treat symptomatic aortic stenosis in patients deemed too high risk for open-heart surgery. To address this complex population, an interdisciplinary heart team approach was proposed. Present the short- and mid-term outcomes of the first 100 patients in the Royal Prince Alfred Hospital multidisciplinary TAVI programme. Single-centre registry. Baseline and procedural data were prospectively recorded. Outcomes were recorded according to Valve Academic Research Consortium - version 2 guidelines. All patients underwent a comprehensive interdisciplinary pre-procedural evaluation. Sixty-eight transfemoral and 32 transapical implantations were performed. Mean age was 82 (±8.9) years old with an average logistic EuroSCORE of 33. Although 13 procedures had major complications, there was no intraprocedural mortality. During the first month, 9% of patients were re-admitted due to heart failure and 13% had a permanent pacemaker implanted. A 3% 30-day and 8% follow-up (mean 17 months) mortalities were recorded. While no significant differences in the rate of complications were found between the first and second half of the experience, all cases of mortality within 30 days (n = 3) occurred in the initial half. Sustained haemodynamic results were obtained with TAVI (immediate mean aortic valve gradient reduction from 47 to 9 mmHg; 1-year echocardiographic gradient 9.9 mmHg, with no moderate or severe aortic regurgitation). Excellent results can be achieved with TAVI in very high-risk patients at an Australian institution. A comprehensive evaluation based on a heart team can overcome most of the difficulties imposed by this challenging population. © 2014 The Authors; Internal Medicine Journal © 2014 Royal Australasian College of Physicians.

Efficacy and safety of transcatheter aortic valve replacement in aortic stenosis patients at low to moderate surgical risk: a comprehensive meta-analysis.

PubMed

Elmaraezy, Ahmed; Ismail, Ammar; Abushouk, Abdelrahman Ibrahim; Eltoomy, Moutaz; Saad, Soha; Negida, Ahmed; Abdelaty, Osama Mahmoud; Abdallah, Ahmed Ramadan; Aboelfotoh, Ahmed Magdy; Hassan, Hossam Mahmoud; Elmaraezy, Aya Gamal; Morsi, Mahmoud; Althaher, Farah; Althaher, Moath; AlSafadi, Ammar M

2017-08-24

Recently, transcatheter aortic valve replacement (TAVR) has become the procedure of choice in high surgical risk patients with aortic stenosis (AS). However, its value is still debated in operable AS cases. We performed this meta-analysis to compare the safety and efficacy of TAVR to surgical aortic valve replacement (SAVR) in low-to-moderate surgical risk patients with AS. A systematic search of five authentic databases retrieved 11 eligible studies (20,056 patients). Relevant Data were pooled as risk ratios (RRs) or standardized mean differences (SMD), with their 95% confidence interval, using Comprehensive Meta-Analysis and RevMan software for windows. At one-year of follow-up, the pooled effect-estimates showed no significant difference between TAVR and SAVR groups in terms of all-cause mortality (RR 1.02, 95% CI [0.83, 1.26], stroke (RR 0.83, 95%CI [0.56, 1.21]), myocardial infarction (RR 0.82, 95% CI [0.57, 1.19]), and length of hospital stay (SMD -0.04, 95% CI [-0.34, 0.26]). The incidence of major bleeding (RR 0.45, 95% CI [0.24, 0.86]) and acute kidney injury (RR 0.52, 95% CI [0.30, 0.88]) was significantly lower in the TAVR group, compared to the SAVR group. However, TAVR was associated with a higher risk of permanent pacemaker implantation (RR 2.57, 95% CI [1.36, 4.86]), vascular-access complications at 1 year (RR 1.99, 95%CI [1.04, 3.80]), and paravalvular aortic regurgitation at 30 days (RR 3.90, 95% CI [1.25, 12.12]), compared to SAVR. Due to the comparable mortality rates in SAVR and TAVR groups and the lower risk of life-threatening complications in the TAVR group, TAVR can be an acceptable alternative to SAVR in low-to-moderate risk patients with AS. However, larger trials with longer follow-up periods are required to compare the long-term outcomes of both techniques.

[Quality of life after transcatheter aortic valve implantation: a Comprehensive literature review and critical appraisal].

PubMed

Ferrari, Susy; Ciuca, Cristina; Grisoglio, Enrica; Aranzulla, Tiziana Claudia; Gabbieri, Davide; Vecchio Verderame, Lavinia; Dispensa, Flavia; Caruso, Cinzia; Di Mauro, Alda Carmela; Di Gregorio, Omar; Pandolfi, Claudia; Rongoni, Silvia; Ottoboni, Giovanni; Moretti, Carolina; De Palma, Rossana; Marzocchi, Antonio; Chattat, Rabih; Saia, Francesco

2016-12-01

Transcatheter aortic valve implantation (TAVI) is a very effective treatment option for patients with severe aortic stenosis who are either not suitable candidates or at high risk for surgical aortic valve replacement (AVR). Patients undergoing TAVI are often very elderly and their clinical status is burdened with multiple comorbidities, therefore evaluation of quality of life (QoL) might be challenging. We sought to provide an overview of available data on QoL changes after TAVI and critical insights on the instruments used to detect these changes. This analysis focuses on studies that evaluated QoL after TAVI with standardized questionnaires. Out of 706 items identified through literature search, 23 studies were included in the final review: 2 randomized controlled trials (one comparing QoL pre- vs post-TAVI, one TAVI vs AVR vs medical therapy) and 21 observational studies (19 studies comparing QoL pre- and post-TAVI and 2 studies TAVI vs AVR). The instruments used in all studies were not specific for TAVI patients. Most studies reported a significant improvement in QoL after TAVI, greater for physical aspects compared with psychological components, which persisted at mid and long-term follow-up. A short-term benefit was found for transfemoral TAVI patients as compared with transapical TAVI and AVR; however, these differences tended to disappear over time. The study highlights an improvement in QoL after TAVI that persists over time. As different instruments resulted to be more sensitive to detect different aspects, multidimensional assessments - capable of combining disease-specific and disease-non-specific measures - should foster clinical research in order to have a more complete picture of QoL of TAVI patients.

Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients: The FRANCE-2 Registry.

PubMed

Gilard, Martine; Eltchaninoff, Hélène; Donzeau-Gouge, Patrick; Chevreul, Karine; Fajadet, Jean; Leprince, Pascal; Leguerrier, Alain; Lievre, Michel; Prat, Alain; Teiger, Emmanuel; Lefevre, Thierry; Tchetche, Didier; Carrié, Didier; Himbert, Dominique; Albat, Bernard; Cribier, Alain; Sudre, Arnaud; Blanchard, Didier; Rioufol, Gilles; Collet, Frederic; Houel, Remi; Dos Santos, Pierre; Meneveau, Nicolas; Ghostine, Said; Manigold, Thibaut; Guyon, Philippe; Grisoli, Dominique; Le Breton, Herve; Delpine, Stephane; Didier, Romain; Favereau, Xavier; Souteyrand, Geraud; Ohlmann, Patrick; Doisy, Vincent; Grollier, Gilles; Gommeaux, Antoine; Claudel, Jean-Philippe; Bourlon, Francois; Bertrand, Bernard; Laskar, Marc; Iung, Bernard

2016-10-11

Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up. This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used. A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade ≥2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in <2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up. The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the

Quality of life in high-risk patients: comparison of transcatheter aortic valve implantation with surgical aortic valve replacement.

PubMed

Amonn, Kathrin; Stortecky, Stefan; Brinks, Henriette; Gahl, Brigitta; Windecker, Stephan; Wenaweser, Peter; Carrel, Thierry; Huber, Christoph

2013-01-01

To compare health-related quality of life (QoL) in patients undergoing transcatheter aortic valve implantation via transapical access (TA TAVI) with patients undergoing surgical aortic valve replacement (SAVR). One hundred and forty-four high-risk patients referred for aortic valve replacement underwent TAVI screening and were assigned to either TA TAVI (n = 51, age 79.7 ± 9.2 years, logistic EuroSCORE 26.5 ± 16.1%, 51% males) or SAVR (n = 93, age 81.1 ± 5.3 years, logistic EuroSCORE 12.1 ± 9.3%, 42% males) by the interdisciplinary heart team. QoL was assessed using the Short Form 36 (SF-36) Health Survey Questionnaire and the Hospital Anxiety and Depression Scale. Furthermore, current living conditions and the degree of independence at home were evaluated. Patients undergoing TA TAVI were at higher risk as assessed by EuroSCORE (26.5 ± 16 vs. 12.1 ± 9, P < 0.001) and STS score (6.7 ± 4 vs. 4.4 ± 3, P < 0.001) compared with SAVR patients. At the 30-day follow-up, the rate of mortality was similar and amounted to 7.8% for TA TAVI and 7.5% for SAVR patients and raised to 25.5% in TA TAVI and 18.3% in SAVR patients after a follow-up period of 15 ± 10 months. Assessment of QoL revealed no differences in terms of anxiety and depression between TA TAVI and SAVR patients. The SF-36 mental health metascore was similar in both groups (65.6 ± 19 vs. 68.8 ± 22, P = 0.29), while a significant difference was observed in the physical health metascore (49.7 ± 21 vs. 62.0 ± 21, P = 0.015). After adjustment for baseline characteristics, this difference disappeared. However, every added point in the preoperative risk assessment with the STS score decreased the SF-36 physical health dimension by two raw points at the follow-up assessment. Selected high-risk patients undergoing TAVI by using a transapical access achieve similar clinical outcomes and QoL compared with patients undergoing SAVR. Increased STS scores predict worse QoL outcomes.

ANMCO/SIC/SICI-GISE/SICCH Executive Summary of Consensus Document on Risk Stratification in elderly patients with aortic stenosis before surgery or transcatheter aortic valve replacement

PubMed Central

Gulizia, Michele Massimo; Baldasseroni, Samuele; Bedogni, Francesco; Cioffi, Giovanni; Indolfi, Ciro; Romeo, Francesco; Murrone, Adriano; Musumeci, Francesco; Parolari, Alessandro; Patanè, Leonardo; Pino, Paolo Giuseppe; Mongiardo, Annalisa; Spaccarotella, Carmen; Di Bartolomeo, Roberto; Musumeci, Giuseppe

2017-01-01

Abstract Aortic stenosis is one of the most frequent valvular diseases in developed countries, and its impact on public health resources and assistance is increasing. A substantial proportion of elderly people with severe aortic stenosis is not eligible to surgery because of the advanced age, frailty, and multiple co-morbidities. Transcatheter aortic valve implantation (TAVI) enables the treatment of very elderly patients at high or prohibitive surgical risk considered ineligible for surgery and with an acceptable life expectancy. However, a significant percentage of patients die or show no improvement in quality of life (QOL) in the follow-up. In the decision-making process, it is important to determine: (i) whether and how much frailty of the patient influences the risk of procedures; (ii) how the QOL and the individual patient’s survival are influenced by aortic valve disease or from other associated conditions; and (iii) whether a geriatric specialist intervention to evaluate and correct frailty or other diseases with their potential or already manifest disabilities can improve the outcome of surgery or TAVI. Consequently, in addition to risk stratification with conventional tools, a number of factors including multi-morbidity, disability, frailty, and cognitive function should be considered, in order to assess the expected benefit of both surgery and TAVI. The pre-operative optimization through a multidisciplinary approach with a Heart Team can counteract the multiple damage (cardiac, neurological, muscular, respiratory, and kidney) that can potentially aggravate the reduced physiological reserves characteristic of frailty. The systematic application in clinical practice of multidimensional assessment instruments of frailty and cognitive function in the screening and the adoption of specific care pathways should facilitate this task. PMID:28751850

Hemodynamic features of congenital aortic valve stenosis with patent ductus arteriosus in children.

PubMed

Xie, Chunhong; Xia, Chengsen; Zhao, Zhengyan; Zhou, Yinbao

2007-12-01

The aim of the present paper was to investigate the hemodynamic features of congenital aortic valvar stenosis (AS) associated with patent ductus arteriosus (PDA), and to develop information to guide management of AS with coexistent PDA. Hemodynamic measurements were performed in eight of 11 patients with AS before and following transcatheter closure of a PDA. Doppler cardiac ultrasound and chest X-rays were performed during follow up. In each of the 11 patients, aortic valve gradient was markedly reduced following transcatheter ductal closure. In only one of them was balloon aortic valvuloplasty necessary. Aortic valve gradient was markedly overestimated before closure of PDA. The significance of this finding has focused on selecting appropriate management so that a PDA is not overlooked when intervention for AS is performed.

Aortic valve calcification as a predictor of location and severity of paravalvular regurgitation after transcatheter aortic valve implantation.

PubMed

Koh, Ezra Y; Lam, Kayan Y; Bindraban, Navin R; Cocchieri, Riccardo; Planken, R Nils; Koch, Karel T; Baan, Jan; de Mol, Bas A; Marquering, Henk A

2015-03-01

To determine whether the location of aortic valve calcium (AVC) influences the location of paravalvular regurgitation (PR). PR is an adverse effect of transcatheter aortic valve implantation (TAVI) with a negative effect on long-term patient survival. The relationship between AVC and the occurrence of PR has been documented. However, the relationship between the distribution of AVC and the location of PR is still sparsely studied. The purpose of this study was to correlate severity and location of AVC with PR in patients treated with TAVI. Fifty-six consecutive patients who underwent transaortic or transapical TAVI and had preoperative computed tomography scans were included in this retrospective study. The volume, mass and location of AVC was determined and compared between patients with and without PR using a non-parametric t-test. Postoperative echocardiography was performed to determine the presence and location of PR, which was associated with the cusp with highest AVC using a χ(2) test. Valve deployment was successful in all 56 patients. PR was present in 38 patients (68%) after TAVI. There was a non-significantly higher volume of AVC in the PR group [214 (70-418) vs 371 (254-606) cm(3), P = 0.15]. AVC mass was significantly higher in patients with PR than in patients without PR [282 (188-421) vs 142 (48-259) mg, respectively, P = 0.043]. The location of PR was determined in 36 of these patients. Of these 36 patients, PR occurred at the cusp with the highest AVC in 20 patients (56%, χ(2) P = 0.030). In our population, PR was associated with greater AVC mass. Moreover, the location of PR was associated with the cusp with the highest amount of AVC. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Stress Analysis of Transcatheter Aortic Valve Leaflets Under Dynamic Loading: Effect of Reduced Tissue Thickness.

PubMed

Abbasi, Mostafa; Azadani, Ali N

2017-07-01

In order to accommodate transcatheter valves to miniaturized catheters, the leaflet thickness must be reduced to a value which is typically less than that of surgical bioprostheses. The study aim was to use finite-element simulations to determine the impact of the thickness reduction on stress and strain distribution. A 23 mm transcatheter aortic valve (TAV) was modelled based on the Edwards SAPIEN XT (Edwards Lifesciences, Irvine, CA, USA). Finite-element (FE) analysis was performed using the ABAQUS/Explicit solver. An ensemble-averaged transvalvular pressure waveform measured from in-vitro tests conducted in a pulse duplicator was applied to the leaflets. Through a parametric study, uniform TAV leaflet thickness was reduced from 0.5 to 0.18 mm. By reducing leaflet thickness, significantly higher stress values were found in the leaflet's fixed edge during systole, and in the commissures during diastole. Through dynamic FE simulations, the highest stress values were found during systole in the leaflet fixed edge. In contrast, at the peak of diastole high-stress regions were mainly observed in the commissures. The peak stress was increased by 178% and 507% within the leaflets after reducing the thickness of 0.5 mm to 0.18 mm at the peak of systole and diastole, respectively. The study results indicated that, the smaller the leaflet thickness, the higher the maximum principal stress. Increased mechanical stress on TAV leaflets may lead to accelerated tissue degeneration. By using a thinner leaflet, TAV durability may not atch with that of surgical bioprostheses.

Assessment of quality of life in patients after surgical and transcatheter aortic valve replacement.

PubMed

Tokarek, Tomasz; Siudak, Zbigniew; Dziewierz, Artur; Sobczyński, Robert; Zasada, Wojciech; Sorysz, Danuta; Olszewska-Wityńska, Katarzyna; Bryniarski, Krzysztof; Krawczyk-Ożóg, Agata; Żabówka, Anna; Sadowski, Jerzy; Dudek, Dariusz

2016-09-01

Transcatheter aortic valve implantation (TAVI) and minimally invasive aortic valve replacement (mini-thoracotomy, mini-sternotomy, MIAVR) have become an appealing alternative to conventional surgical (SAVR) treatment of severe aortic stenosis (AS) in high-risk patients. Aim of the study was to evaluate the quality of life (QoL) in patients with AS and treated with transfemoral TAVI, SAVR, mini-thoracotomy and mini-sternotomy. One hundred and seventy-three patients with symptomatic AS were enrolled in 2011-2013. TAVI group consisted of 39 patients (22.5%), mini-sternotomy was performed in 44 patients (25.5%), mini-thoracotomy in 50 (29%), and AVR in 40 patients (23%). QoL was assessed perioperatively, 12 and 24 months after aortic valve replacement (AVR) by Minnesota Living with Heart Failure Questionnaire (MLHFQ) and EQ-5D-3L. Median follow-up was 583.5 (IQR: 298-736) days. Improvement of health status after procedure in comparison with pre-operative period was significantly more often reported after TAVI in perioperative period (90.3%; P = 0.004) and 12 months after procedure (100%, P = 0.02). Global MLHFQ, physical and emotional dimension score at 30-day from AVR presented significant improvement after TAVI in comparison with surgical methods (respectively: 8.3(±8.6), P = 0.003; 4.1(±5.9), P = 0.01; 1.5(±2.6), P = 0.005). Total MLHFQ score was significantly lower (better outcome) in TAVI patients 1 year after procedure (4.8(±6.8), P = 0.004), no differences in somatic and emotional component were found. No differences were found in MLHFQ score 24 months after AVR. Data from EQ-D5-3L questionnaire demonstrated significant improvement of QoL at 30-day follow-up after TAVI in comparison with surgical methods (1.2(±1.7), P = 0.0008). TAVI improves QoL in perioperative and 12 months observation in comparison with mini-thoracotomy, mini-sternotomy and SAVR. Improvement in QoL was obtained in both generic and disease specific

Impact of electrocardiogram-gated multi-slice computed tomography-based aortic annular measurement in the evaluation of paravalvular leakage following transcatheter aortic valve replacement: the efficacy of the OverSized AortiC Annular ratio (OSACA ratio) in TAVR.

PubMed

Maeda, Koichi; Kuratani, Toru; Torikai, Kei; Shimamura, Kazuo; Mizote, Isamu; Ichibori, Yasuhiro; Takeda, Yasuharu; Daimon, Takashi; Nakatani, Satoshi; Nanto, Shinsuke; Sawa, Yoshiki

2013-07-01

Even mild paravalvular leakage (PVL) after transcatheter aortic valve replacement (TAVR) is associated with increased late mortality. Electrocardiogram-gated multi-slice computed tomography (MSCT) enables detailed aortic annulus assessment. We describe the impact of MSCT for PVL following TAVR. Congruence between the prosthesis and annulus diameters affects PVL; therefore, we calculated the OverSized AortiC Annular ratio (OSACA ratio) and OSACA (transesophageal echocardiography, TEE) ratio as prosthesis diameter/annulus diameter on MSCT or TEE, respectively, and compared their relationship with PVL ≤ trace following TAVR. Of 36 consecutive patients undergoing TAVR (Group A), the occurrence of PVL ≤ trace (33.3%) was significantly related to the OSACA ratio (p = 0.00020). In receiver-operating characteristics analysis, the cutoff value of 1.03 for the OSACA ratio had the highest sum of sensitivity (75.0%) and specificity (91.7%; AUC = 0.87) with significantly higher discriminatory performance for PVL as compared to the OSACA (TEE) ratio (AUC = 0.69, p = 0.028). In nine consecutive patients (Group B) undergoing TAVR based on guidelines formulated from our experience with Group A, PVL ≤ trace was significantly more frequent (88.9%) than that in Group A (p = 0.0060). The OSACA ratio has a significantly higher discriminatory performance for PVL ≤ trace than the OSACA (TEE) ratio, and aortic annular measurement from MSCT is more accurate than that from TEE. © 2013 Wiley Periodicals, Inc.

Incidence and impact of prosthesis-patient mismatch after transcatheter aortic valve implantation.

PubMed

Bleiziffer, Sabine; Hettich, Ina; Hutter, Andrea; Wagner, Anke; Deutsch, Marcus-André; Piazza, Nicolo; Lange, Rüdiger

2013-05-01

The study aim was to investigate the incidence of patient-prosthesis mismatch (PPM) with new catheter valves, and its influence on the patients' clinical state. At present, few echocardiographic data are available on the incidence and impact of PPM with the CoreValve and Sapien prostheses for transcatheter aortic valve implantation (TAVI). The reliability of effective orifice area (EOA) measurements was assured by awaiting an interval of six months after TAVI. Of 256 survivors after TAVI, 149 complete echocardiographic data sets were available for the assessment of the indexed EOA (iEOA). In total, 106 CoreValve prostheses and 43 Sapien prostheses were implanted in this high-risk cohort (mean age 81 +/- 6 years, mean logistic EuroSCORE 20 +/- 13%). The overall incidence of PPM (iEOA < 0.85 cm2/m2) was 61%. Patients with a larger body surface area were more likely to develop PPM (p = 0.001), while the prosthesis type, native annulus diameter, preoperative EOA, gender and prosthesis size had no influence. The mean aortic gradient was significantly higher in patients with PPM. A reduction in the left ventricular end-diastolic diameter was seen in all patients, without significant differences between groups. There were no differences in postoperative NYHA class or self-assessed health state between patients with or without PPM. PPM was common after TAVI in the presented cohort, presumably because the native calcium masses narrow the outflow area available for blood flow. As expected for low gradients, there was no impairment of left ventricular dimension regression or clinical state of the patients, even if severe PPM was present. Based on the presented data, it is assumed that PPM might be less relevant in TAVI patients.

Post-procedural hypertension following transcatheter aortic valve implantation: incidence and clinical significance.

PubMed

Perlman, Gidon Y; Loncar, Sasa; Pollak, Arthur; Gilon, Dan; Alcalai, Ronny; Planer, David; Lotan, Chaim; Danenberg, Haim D

2013-05-01

This study sought to investigate the blood pressure (BP) response after transcatheter aortic valve implantation (TAVI) and its correlation with short- and mid-term clinical outcomes. TAVI is an emerging therapy for aortic stenosis patients at high surgical risk. The acute hemodynamic sequelae of this procedure and their clinical relevance are yet unclear. Consecutive patients who underwent TAVI in a single center were prospectively monitored for BP response during 5 post-procedural days. Clinical parameters, adverse events, and medical treatment were recorded during hospitalization, at 30 days, and at 12 months after the procedure. Patients were divided according to their post-procedural BP response into 2 groups: increased BP and stable BP. One hundred and five patients were analyzed. Overall, systolic BP increased immediately after TAVI in the entire cohort by an average of 15 ± 31 mm Hg. This rise was sustained and led to intensification of antihypertensive treatment in 53 patients (51%); these patients were designated as the increased BP group. The increase in systolic BP after TAVI was associated with an increase in stroke volume and cardiac output and was not related to age, baseline cardiac function, or procedural outcomes. Patients with increased BP after TAVI had a significantly better prognosis with fewer adverse events in the hospital (21% vs. 62%, p < 0.01), after 30 days (30% vs. 71%, p < 0.01), and after 12 months (53% vs. 83%, p < 0.01) as compared with patients with stable BP. After TAVI, a substantial number of patients have a significant rise in systolic BP necessitating long-term treatment. This increase in BP is associated with an increase in cardiac output and predicts a better clinical outcome. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Surgical site infections following transcatheter apical aortic valve implantation: incidence and management.

PubMed

Baillot, Richard; Fréchette, Éric; Cloutier, Daniel; Rodès-Cabau, Josep; Doyle, Daniel; Charbonneau, Éric; Mohammadi, Siamak; Dumont, Éric

2012-11-13

The present study was undertaken to examine the incidence and management of surgical site infection (SSI) in patients submitted to transapical transcatheter aortic valve implantation (TA-TAVI). From April 2007 to December 2011, 154 patients underwent TA-TAVI with an Edwards Sapien bioprosthesis (ES) at the Institut Universitaire de Cardiologie et Pneumologie de Québec (IUCPQ) as part of a multidisciplinary program to prospectively evaluate percutaneous aortic valve implantation. Patient demographics, perioperative variables, and postoperative complications were recorded in a prospective registry. Five (3.2%) patients in the cohort presented with an SSI during the study period. The infections were all hospital-acquired (HAI) and were considered as organ/space SSI's based on Center for Disease Control criteria (CDC). Within the first few weeks of the initial procedure, these patients presented with an abscess or chronic draining sinus in the left thoracotomy incision and were re-operated. The infection spread to the apex of the left ventricle in all cases where pledgeted mattress sutures could be seen during debridement. Patients received multiple antibiotic regimens without success until the wound was surgically debrided and covered with viable tissue. The greater omentum was used in three patients and the pectoralis major muscle in the other two. None of the patients died or had a recurrent infection. Three of the patients were infected with Staphylococcus epidermidis, one with Staphylococcus aureus, and one with Enterobacter cloacae. Patients with surgical site infections were significantly more obese with higher BMI (31.4±3.1 vs 26.2±4.4 p=0.0099) than the other patients in the cohort. While TA-TAVI is a minimally invasive technique, SSIs, which are associated with obesity, remain a concern. Debridement and rib resection followed by wound coverage with the greater omentum and/or the pectoralis major muscle were used successfully in these patients.

Aspirin Versus Aspirin Plus Clopidogrel as Antithrombotic Treatment Following Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve: The ARTE (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation) Randomized Clinical Trial.

PubMed

Rodés-Cabau, Josep; Masson, Jean-Bernard; Welsh, Robert C; Garcia Del Blanco, Bruno; Pelletier, Marc; Webb, John G; Al-Qoofi, Faisal; Généreux, Philippe; Maluenda, Gabriel; Thoenes, Martin; Paradis, Jean-Michel; Chamandi, Chekrallah; Serra, Vicenç; Dumont, Eric; Côté, Mélanie

2017-07-10

The aim of this study was to compare aspirin plus clopidogrel with aspirin alone as antithrombotic treatment following transcatheter aortic valve replacement (TAVR) for the prevention of ischemic events, bleeding events, and death. Few data exist on the optimal antithrombotic therapy following TAVR. This was a randomized controlled trial comparing aspirin (80 to 100 mg/day) plus clopidogrel (75 mg/day) (dual antiplatelet therapy [DAPT]) versus aspirin alone (single-antiplatelet therapy [SAPT]) in patients undergoing TAVR with a balloon-expandable valve. The primary endpoint was the occurrence of death, myocardial infarction (MI), stroke or transient ischemic attack, or major or life-threatening bleeding (according to Valve Academic Research Consortium 2 definitions) within the 3 months following the procedure. The trial was prematurely stopped after the inclusion of 74% of the planned study population. A total of 222 patients were included, 111 allocated to DAPT and 111 to SAPT. The composite of death, MI, stroke or transient ischemic attack, or major or life-threatening bleeding tended to occur more frequently in the DAPT group (15.3% vs. 7.2%, p = 0.065). There were no differences between groups in the occurrence of death (DAPT, 6.3%; SAPT, 3.6%; p = 0.37), MI (DAPT, 3.6%; SAT, 0.9%; p = 0.18), or stroke or transient ischemic attack (DAPT, 2.7%; SAPT, 0.9%; p = 0.31) at 3 months. DAPT was associated with a higher rate of major or life-threatening bleeding events (10.8% vs. 3.6% in the SAPT group, p = 0.038). There were no differences between groups in valve hemodynamic status post-TAVR. This small trial showed that SAPT (vs. DAPT) tended to reduce the occurrence of major adverse events following TAVR. SAPT reduced the risk for major or life-threatening events while not increasing the risk for MI or stroke. Larger studies are needed to confirm these results. (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation: The ARTE

Perioperative Results and Complications in 15,964 Transcatheter Aortic Valve Replacements: Prospective Data From the GARY Registry.

PubMed

Walther, Thomas; Hamm, Christian W; Schuler, Gerhard; Berkowitsch, Alexander; Kötting, Joachim; Mangner, Norman; Mudra, Harald; Beckmann, Andreas; Cremer, Jochen; Welz, Armin; Lange, Rüdiger; Kuck, Karl-Heinz; Mohr, Friedrich W; Möllmann, Helge

2015-05-26

Transcatheter aortic valve replacement (TAVR) has evolved into a routine procedure with good outcomes in high-risk patients. TAVR complication rates were evaluated based on prospective data from the German Aortic Valve Registry (GARY). From 2011 to 2013, a total of 15,964 TAVR procedures were registered. We evaluated the total cohort for severe vital complications (SVCs), including the following: death on the day of intervention, conversion to sternotomy, low cardiac output that required mechanical support, aortic dissection, and annular rupture; technical complications of the procedures (TCOs), such as repositioning or retrieval of the valve prosthesis and embolization of the prosthesis; and other complications. Mean patient age was 81 ± 6 years, 54% of the patients were women, the median logistic Euroscore I was 18.3, the German aortic valve score was 5.6, and the Society of Thoracic Surgeons score was 5.0. Overall in-hospital mortality was 5.2%, whereas SVCs occurred in 5.0% of the population. Independent predictors for SVCs were female sex, pre-operative New York Heart Association functional class IV, ejection fraction <30%, pre-operative intravenous inotropes, arterial vascular disease, and higher degree of calcifications. TCOs occurred in 4.7% of patients and decreased significantly from 2011 to 2013. An emergency sternotomy was performed in 1.3% of the patients; however, multivariate analysis did not identify any predictors for conversion to sternotomy. The all-comers GARY registry revealed good outcomes after TAVR and a regression in complications. Survival of approximately 60% of patients who experienced SVCs or who required sternotomy underlines the need for heart team-led indication, intervention, and follow-up care of TAVR patients. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Low permanent pacemaker rates following Lotus device implantation for transcatheter aortic valve replacement due to modified implantation protocol.

PubMed

Krackhardt, Florian; Kherad, Behrouz; Krisper, Maximilian; Pieske, Burkert; Laule, Michael; Tschöpe, Carsten

2017-01-01

Conduction disturbances requiring permanent pacemaker implantation following transcatheter aortic valve replacement (TAVR) are a common problem. Pacemaker implantation rates after TAVR appear to be higher compared to conventional aortic valve replacement. The aim of this study was to analyze whether a high annulus implantation conveys the benefit of a decreased rate of permanent pacemaker implantation while being safe and successful according to Valve Academic Research Consortium 2 (VARC2)-criteria. A total of 23 patients with symptomatic severe aortic valve stenosis, an aortic annulus of 19-27 mm and at high risk for surgery were treated with the Lotus valve. In all patients the valve was implanted in a high annulus position via femoral access. The primary device performance endpoint was VARC2-defined device success after 30 days and the primary safety endpoint was the need for permanent pacemaker implantation. The mean age was 73.23 ± 7.65 years, 46% were female, 38% were New York Heart Association class III/IV at baseline. Thirty-day follow-up data were available for all patients. The VARC2-defined device success rate after 30 days was 22/23 (96%). 2/21 (10%) patients required a newly implanted pacemaker due to 3rd degree atrioventricular block. 25% of the patients developed a new left bundle branch block after valvuloplasty or device implantation. 21 of the 23 patients (96%) had no other signs of conduction disturbances after 30 days. The approach of the modified implantation technique of Lotus TAVR device was safe and effective. The incidence of need for a permanent pacemaker following TAVR could be significantly reduced due to adopted implantation protocol.

Real-time magnetic resonance imaging-guided transcatheter aortic valve replacement.

PubMed

Miller, Justin G; Li, Ming; Mazilu, Dumitru; Hunt, Tim; Horvath, Keith A

2016-05-01

To demonstrate the feasibility of Real-time magnetic resonance imaging (rtMRI) guided transcatheter aortic valve replacement (TAVR) with an active guidewire and an MRI compatible valve delivery catheter system in a swine model. The CoreValve system was minimally modified to be MRI-compatible by replacing the stainless steel components with fluoroplastic resin and high-density polyethylene components. Eight swine weighing 60-90 kg underwent rtMRI-guided TAVR with an active guidewire through a left subclavian approach. Two imaging planes (long-axis view and short-axis view) were used simultaneously for real-time imaging during implantation. Successful deployment was performed without rapid ventricular pacing or cardiopulmonary bypass. Postdeployment images were acquired to evaluate the final valve position in addition to valvular and cardiac function. Our results show that the CoreValve can be easily and effectively deployed through a left subclavian approach using rtMRI guidance, a minimally modified valve delivery catheter system, and an active guidewire. This method allows superior visualization before deployment, thereby allowing placement of the valve with pinpoint accuracy. rtMRI has the added benefit of the ability to perform immediate postprocedural functional assessment, while eliminating the morbidity associated with radiation exposure, rapid ventricular pacing, contrast media renal toxicity, and a more invasive procedure. Use of a commercially available device brings this rtMRI-guided approach closer to clinical reality. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Early Transcatheter Aortic Valve Function With and Without Therapeutic Anticoagulation.

PubMed

Hiremath, Pranoti G; Kearney, Kathleen; Smith, Bryn; Don, Creighton; Dvir, Danny; Aldea, Gabriel; Reisman, Mark; McCabe, James M

2017-11-01

Prosthetic leaflet thrombosis is a growing concern in transcatheter aortic valve replacement (TAVR). Given the uncertainty of best practices for antiplatelet and anticoagulation therapies in the post-TAVR period, additional evidence regarding the impact of anticoagulation on prosthetic valve function after TAVR is needed. Patients undergoing native-valve TAVR at a single academic institution between 2012 and 2015 were analyzed based on any anticoagulant use at hospital discharge post TAVR. Changes in prosthetic valve peak velocity and mean gradient were assessed based on transthoracic echocardiograms performed immediately following valve implant and at 4-week follow-up. Multivariate regression analyses were performed to explore the impact of anticoagulation status on early TAVR valve performance. For 403 patients, there were no available data to analyze. Of those, 29.6% were discharged on anticoagulation. Following TAVR, the average mean prosthetic valve gradient was 11.8 ± 5.6 mm Hg and peak velocity was 2.33 ± 0.52 m/s. There were no significant differences between anticoagulated and non-anticoagulated groups in the mean or peak gradients or velocity immediately following implant or at 4 weeks, which remained true following multivariate adjustment (P=.80 for delta mean gradient; P=.91 for delta peak velocity). Our data suggest that the absence of anticoagulation is not associated with short-term degradation in TAVR performance and do not support the routine use of anticoagulation following native-valve TAVR.

Outcomes of transcatheter aortic valve replacement using a minimalist approach.

PubMed

Gurevich, Sergey; Oestreich, Brett; Kelly, Rosemary F; Mbai, Mackenzie; Bertog, Stefan; Ringsred, Karen; Lawton, Annette; Thooft, Brenda; Wagner, Julie; Garcia, Santiago

2018-03-01

Transcatheter Aortic Valve Replacement (TAVR) is increasingly performed using a minimalist approach under monitored anesthesia care (MAC). The safety of this approach remains controversial and adoption has been low in the US. The study cohort was comprised of 130 patients (98% male) who underwent TAVR between 4/2015 and 4/2017 at the Minneapolis VA. We compared the outcomes of 81 patients who underwent TAVR using a standard approach (standard TAVR) and 49 who underwent TAVR using a minimalist approach (minimalist TAVR). Outcome measures included device and procedural success, procedural efficiency, length of intensive care unit (ICU) and hospital stay, procedural complications and hospital readmissions. Mean age was 80 (±9) years and median (IQR) STS score was 5 (4-6). Access included transfemoral (n = 111, 85%) and alternative (n = 19, 15%). Minimalist TAVR was associated with reduced procedural time: median 101 min (IQR: 78-135) versus 127 min (IQR: 97-182, p = 0.03), fluoroscopy time: median 18 min (IQR: 12-26) versus 24 min (IQR: 16-38), p = 0.001), contrast volume 90 ml (IQR: 70-120 ml) versus 140 ml (IQR: 86-213 ml, p < 0.001). A minimalistic approach to TAVR is associated with improved procedural efficiency and reduced length of stay without compromising procedural success or clinical outcomes. Published by Elsevier Inc.

Patients' self-reported function, symptoms and health-related quality of life before and 6 months after transcatheter aortic valve implantation and surgical aortic valve replacement.

PubMed

Olsson, Karin; Nilsson, Johan; Hörnsten, Åsa; Näslund, Ulf

2017-03-01

Aortic stenosis is the most common valve disease in western countries and has poor prognosis without treatment. Surgical aortic valve replacement (SAVR) is the gold standard, and transcatheter aortic valve implantation (TAVI) is a new method that is used in high-risk patients who are denied surgery. The purpose of treatment is not only to save life, but also to reduce symptoms and increase health-related quality of life (HRQoL). The aim of this study was to describe patients' self-reported outcomes in terms of physical function, symptoms, dependence, HRQoL, and cognitive function after TAVI and SAVR. All patients treated with TAVI during 1 year ( n = 24) and age-matched patients treated with SAVR ( n = 24) were included. Data were collected on the day before and at 6 months after treatment using structural questionnaires. Self-rated function was low before treatment and increased at follow-up. A quarter of all patients reported syncope at baseline, and none reported this at follow-up. Breathlessness was reported by all patients to be the most limiting cardiac symptom, but the TAVI patients reported more severe symptoms. At 6 months' follow-up, symptoms were reduced, but breathlessness and fatigue were still common, especially in the TAVI group. HRQoL, which was very low in the TAVI group at baseline, increased in all dimensions except social function. We found no change in cognitive function or dependence at follow-up. There was no difference in the size of improvement between groups. The results could be helpful when informing future patients in order to give them realistic expectations.

Very Low Intravenous Contrast Volume Protocol for Computed Tomography Angiography Providing Comprehensive Cardiac and Vascular Assessment Prior to Transcatheter Aortic Valve Replacement in Patients with Chronic Kidney Disease

PubMed Central

Pulerwitz, Todd C.; Khalique, Omar K.; Nazif, Tamim N.; Rozenshtein, Anna; Pearson, Gregory D.N.; Hahn, Rebecca T.; Vahl, Torsten P.; Kodali, Susheel K.; George, Isaac; Leon, Martin B.; D'Souza, Belinda; Po, Ming Jack; Einstein, Andrew J.

2016-01-01

Background Transcatheter aortic valve replacement (TAVR) is a lifesaving procedure for many patients high risk for surgical aortic valve replacement. The prevalence of chronic kidney disease (CKD) is high in this population, and thus a very low contrast volume (VLCV) computed tomography angiography (CTA) protocol providing comprehensive cardiac and vascular imaging would be valuable. Methods 52 patients with severe, symptomatic aortic valve disease, undergoing pre-TAVR CTA assessment from 2013-4 at Columbia University Medical Center were studied, including all 26 patients with CKD (eGFR<30mL/min) who underwent a novel VLCV protocol (20mL of iohexol at 2.5mL/s), and 26 standard-contrast-volume (SCV) protocol patients. Using a 320-slice volumetric scanner, the protocol included ECG-gated volume scanning of the aortic root followed by medium-pitch helical vascular scanning through the femoral arteries. Two experienced cardiologists performed aortic annulus and root measurements. Vascular image quality was assessed by two radiologists using a 4-point scale. Results VLCV patients had mean(±SD) age 86±6.5, BMI 23.9±3.4 kg/m2 with 54% men; SCV patients age 83±8.8, BMI 28.7±5.3 kg/m2, 65% men. There was excellent intra- and inter-observer agreement for annular and root measurements, and excellent agreement with 3D-transesophageal echocardiographic measurements. Both radiologists found diagnostic-quality vascular imaging in 96% of VLCV and 100% of SCV cases, with excellent inter-observer agreement. Conclusions This study is the first of its kind to report the feasibility and reproducibility of measurements for a VLCV protocol for comprehensive pre-TAVR CTA. There was excellent agreement of cardiac measurements and almost all studies were diagnostic quality for vascular access assessment. PMID:27061253

Continuous PECS II block for postoperative analgesia in patients undergoing transapical transcatheter aortic valve implantation.

PubMed

Shakuo, Tomoharu; Kakumoto, Shinichi; Kuribayashi, Junya; Oe, Katsunori; Seo, Katsuhiro

2017-01-01

It has been reported that PECS II block can alleviate postoperative pain following transapical transcatheter aortic valve implantation (TA-TAVI). However, the effectiveness of continuous PECS II block with catheterization has not yet been reported on the postoperative pain in patients undergoing TA-TAVI. We experienced two cases of TA-TAVI who received PECS II block with catheterization to manage postoperative pain. In the first case, a bolus injection for intraoperative pain and subsequent catheterization were performed before the implantation. However, the patient developed severe pain postoperatively in spite of the continuous block due to displacement of the catheter. In the second case, a bolus injection and the catheterization for the continuous block were performed before and after the implantation, respectively, which provided high-quality pain control. Continuous PECS II block may be useful to control perioperative pain associated with TA-TAVI. The insertion of the catheter after the implantation could be useful to avoid its displacement during the surgery.

Percutaneous transcatheter aortic valve implantation for degenerated surgical bioprostheses: the first case series in Asia with one-year follow-up.

PubMed

Chiam, Paul Toon-Lim; Ewe, See-Hooi; Soon, Jia-Lin; Ho, Kay-Woon; Sin, Yong-Koong; Tan, Swee-Yaw; Lim, Soo-Teik; Koh, Tian-Hai; Chua, Yeow-Leng

2016-07-01

Percutaneous transcatheter aortic valve implantation (TAVI) has become an established therapy for inoperable and high-surgical-risk patients with severe aortic stenosis. Although TAVI in patients with degenerated surgical aortic bioprostheses (i.e. valve-in-valve TAVI) is increasingly reported in Western studies, such data is lacking in Asian patients. We describe the initial experience of valve-in-valve TAVI in Asia. Eight patients who underwent valve-in-valve TAVI due to degenerated aortic bioprostheses were enrolled. The mechanism of bioprosthetic valve failure was stenotic, regurgitation or mixed. All procedures were performed via transfemoral arterial access, using the self-expanding CoreValve prosthesis or balloon-expandable SAPIEN XT prosthesis. The mean age of the patients was 71.6 ± 13.2 years and five were male. Mean duration to surgical bioprosthesis degeneration was 10.2 ± 4.1 years. Valve-in-valve TAVI was successfully performed in all patients. CoreValve and SAPIEN XT prostheses were used in six and two patients, respectively. There were no deaths, strokes or permanent pacemaker requirement at 30 days, with one noncardiac mortality at one year. All patients experienced New York Heart Association functional class improvement. Post-procedure mean pressure gradients were 20 ± 11 mmHg and 22 ± 8 mmHg at 30 days and one year, respectively. Residual aortic regurgitation (AR) of more than mild severity occurred in one patient at 30 days. At one year, only one patient had mild residual AR. In our experience of valve-in-valve TAVI, procedural success was achieved in all patients without adverse events at 30 days. Good clinical and haemodynamic outcomes were sustained at one year. Copyright © Singapore Medical Association.

The silent and apparent neurological injury in transcatheter aortic valve implantation study (SANITY): concept, design and rationale.

PubMed

Fanning, Jonathon P; Wesley, Allan J; Platts, David G; Walters, Darren L; Eeles, Eamonn M; Seco, Michael; Tronstad, Oystein; Strugnell, Wendy; Barnett, Adrian G; Clarke, Andrew J; Bellapart, Judith; Vallely, Michael P; Tesar, Peter J; Fraser, John F

2014-04-05

The incidence of clinically apparent stroke in transcatheter aortic valve implantation (TAVI) exceeds that of any other procedure performed by interventional cardiologists and, in the index admission, occurs more than twice as frequently with TAVI than with surgical aortic valve replacement (SAVR). However, this represents only a small component of the vast burden of neurological injury that occurs during TAVI, with recent evidence suggesting that many strokes are clinically silent or only subtly apparent. Additionally, insult may manifest as slight neurocognitive dysfunction rather than overt neurological deficits. Characterisation of the incidence and underlying aetiology of these neurological events may lead to identification of currently unrecognised neuroprotective strategies. The Silent and Apparent Neurological Injury in TAVI (SANITY) Study is a prospective, multicentre, observational study comparing the incidence of neurological injury after TAVI versus SAVR. It introduces an intensive, standardised, formal neurologic and neurocognitive disease assessment for all aortic valve recipients, regardless of intervention (SAVR, TAVI), valve-type (bioprosthetic, Edwards SAPIEN-XT) or access route (sternotomy, transfemoral, transapical or transaortic). Comprehensive monitoring of neurological insult will also be recorded to more fully define and compare the neurological burden of the procedures and identify targets for harm minimisation strategies. The SANITY study undertakes the most rigorous assessment of neurological injury reported in the literature to date. It attempts to accurately characterise the insult and sustained injury associated with both TAVI and SAVR in an attempt to advance understanding of this complication and associations thus allowing for improved patient selection and procedural modification.

The Polish Interventional Cardiology TAVI Survey (PICTS): adoption and practice of transcatheter aortic valve implantation in Poland.

PubMed

Parma, Radosław; Dąbrowski, Maciej; Ochała, Andrzej; Witkowski, Adam; Dudek, Dariusz; Siudak, Zbigniew; Legutko, Jacek

2017-01-01

Few studies have assessed the development of transcatheter aortic valve implantation (TAVI) in Poland since its introduction in 2008, and data on current TAVI activity or practice are missing. To assess the dynamics of TAVI adoption in Poland and to detect differences among Polish centres in TAVI practice and decision-making. The Polish Interventional Cardiology TAVI Survey (PICTS) was approved by the Polish Association of Cardiovascular Interventions and presented to all 21 national TAVI centres. Between 2008 and 2015 the cumulative number of TAVI performed in Poland was 2189. The annual number of TAVI rose from 8 in 2008 to 670 in 2015 (0.21 to 17.4 implants per million inhabitants, respectively). The median TAVI experience per centre was 80 procedures (95% CI: 38.1-154.6). In 2015 the TAVI penetration rate reached 5.12% of the estimated eligible Polish population. Inoperable and high-risk patients are treated with TAVI in all centres, with 52% of Heart Teams also qualifying medium-risk patients. The rate of transfemoral implantations increased to 83.2% of all procedures in 2015, while transapical implantations decreased to 12%. The frequency of subclavian, direct aortic or transcarotid routes in 2015 was below 3% each. The PICTS survey observed a positive but slow rate of adoption of TAVI in Poland. When compared to Western European countries, our findings highlight a significant treatment gap in high or prohibitive surgical risk patients with severe aortic stenosis. Remarkable variations in TAVI practices among Polish TAVI centres warrant publication of joint national guidelines and recommendations.

Association of Tricuspid Regurgitation With Transcatheter Aortic Valve Replacement Outcomes: A Report From The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

PubMed

McCarthy, Fenton H; Vemulapalli, Sreekanth; Li, Zhuokai; Thourani, Vinod; Matsouaka, Roland A; Desai, Nimesh D; Kirtane, Ajay; Anwaruddin, Saif; Williams, Matthew L; Giri, Jay; Vallabhajosyula, Prashanth; Li, Robert H; Herrmann, Howard C; Bavaria, Joseph E; Szeto, Wilson Y

2018-04-01

The purpose of this study is to evaluate the association of tricuspid regurgitation (TR) severity with outcomes after transcatheter aortic valve replacement (TAVR). We analyzed data from 34,576 patients who underwent TAVR at 365 US hospitals from November 2011 through March 2015 submitted to The Society of Thoracic Surgeon/American College of Cardiology Transcatheter Valve Therapy Registry. We examined unadjusted mortality and heart failure readmission stratified by degree of preoperative TR and used multivariable models for 1-year mortality and heart failure readmission. Tricuspid regurgitation was present in 80% (n = 27,804) of TAVR patients, with mild TR in 56% (n = 19,393), moderate TR in 19% (n = 6687), and severe TR in 5% (n = 1,724). Increasing TR severity was associated with a number of comorbidities and The Society of Thoracic Surgeons predicted risk of mortality increased (p < 0.001): no TR (7.3 ± 5.4); mild TR (8.0 ± 5.7); moderate TR (9.6 ± 6.8); and severe TR (10.7 ± 7.4). In unadjusted analysis, moderate and severe TR were associated with increased use of cardiopulmonary bypass, longer intensive care unit and hospital stays, new dialysis, inhospital major adverse cardiac event, inhospital mortality, observed-to-expected inhospital mortality ratio, long-term heart failure readmission, and mortality (p < 0.001). Adjusted mortality at 1 year was significantly worse for patients with severe TR when left ventricular ejection fraction greater than 30% (hazard ratio 1.29, 95% confidence interval: 1.11 to 1.50) as was heart failure readmission (hazard ratio 1.27, 95% confidence interval: 1.04 to 1.54). Tricuspid regurgitation was common among patients undergoing TAVR. Increasing TR severity was associated with higher risk patients and increased mortality and readmission-particularly for patients with severe TR and left ventricular ejection fraction greater than 30%. The effectiveness of TAVR alone in patients with aortic stenosis and concomitant

Causes of Death Following Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

PubMed

Xiong, Tian-Yuan; Liao, Yan-Biao; Zhao, Zhen-Gang; Xu, Yuan-Ning; Wei, Xin; Zuo, Zhi-Liang; Li, Yi-Jian; Cao, Jia-Yu; Tang, Hong; Jilaihawi, Hasan; Feng, Yuan; Chen, Mao

2015-09-21

Transcatheter aortic valve replacement (TAVR) is an effective alternative to surgical aortic valve replacement in patients at high surgical risk. However, there is little published literature on the exact causes of death. The PubMed database was systematically searched for studies reporting causes of death within and after 30 days following TAVR. Twenty-eight studies out of 3934 results retrieved were identified. In the overall analysis, 46.4% and 51.6% of deaths were related to noncardiovascular causes within and after the first 30 days, respectively. Within 30 days of TAVR, infection/sepsis (18.5%), heart failure (14.7%), and multiorgan failure (13.2%) were the top 3 causes of death. Beyond 30 days, infection/sepsis (14.3%), heart failure (14.1%), and sudden death (10.8%) were the most common causes. All possible subgroup analyses were made. No significant differences were seen for proportions of cardiovascular deaths except the comparison between moderate (mean STS score 4 to 8) and high (mean STS score >8) -risk patients after 30 days post-TAVR (56.0% versus 33.5%, P=0.005). Cardiovascular and noncardiovascular causes of death are evenly balanced both in the perioperative period and at long-term follow-up after TAVR. Infection/sepsis and heart failure were the most frequent noncardiovascular and cardiovascular causes of death. This study highlights important areas of clinical focus that could further improve outcomes after TAVR. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

TriGuard™ HDH embolic deflection device for cerebral protection during transcatheter aortic valve replacement.

PubMed

Samim, Mariam; van der Worp, Bart; Agostoni, Pierfrancesco; Hendrikse, Jeroen; Budde, Ricardo P J; Nijhoff, Freek; Ramjankhan, Faiz; Doevendans, Pieter A; Stella, Pieter R

2017-02-15

This study aims to evaluate the safety and performance of the new embolic deflection device TriGuard™HDH in patients undergoing TAVR. Transcatheter aortic valve replacement (TAVR) is associated with a high incidence of new cerebral ischemic lesions. The use of an embolic protection device may reduce the frequency of TAVR-related embolic events. This prospective, single arm feasibility pilot study included 14 patients with severe symptomatic aortic stenosis scheduled for TAVR. Cerebral diffusion weighted magnetic resonance imaging (DWI) was planned in all patients one day before and at day 4 (±2) after the procedure. Major adverse cerebral and cardiac events (MACCEs) were recorded for all patients. Primary endpoints of this study were I) device performance success defined as coverage of the aortic arch takeoffs throughout the entire TAVR procedure and II) MACCE occurrence. Secondary endpoints included the number and the volume of new cerebral ischemic lesions on DWI. Thirteen patients underwent transfemoral TAVR and one patient a transapical procedure. Edwards SAPIEN valve prosthesis was implanted in 8 (57%) patients and Medtronic CoreValve prosthesis in the remaining 6 (43%). Predefined performance success of the TriGuard™HDH device was achieved in 9 (64%) patients. The composite endpoint MACCE occurred in none of the patients. Post-procedural DWI was performed in 11 patients. Comparing the DWI of these patients to a historical control group showed no reduction in number [median 5.5 vs. 5.0, P = 0.857], however there was a significant reduction in mean lesion volume per patient [median 13.8 vs. 25.1, P = 0.049]. This study showed the feasibility and safety of using the TriGuard™HDH for cerebral protection during TAVR. This device did not decrease the number of post-procedural new cerebral DWI lesions, however its use showed decreased lesion volume as compared to unprotected TAVR. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Transapical Transcatheter Aortic Valve Implantation Using the JenaValve: A One-Year Follow-up.

PubMed

Reuthebuch, Oliver; Koechlin, Luca; Kaufmann, Beat A; Kessel-Schaefer, Arnheid; Gahl, Brigitta; Eckstein, Friedrich S

2015-09-01

Since the first transcatheter aortic valve implantation (TAVI) in 2002, TAVI technique has gained an increasing popularity especially in high-risk patients. In this study, we present the first echocardiographic midterm outcome with the second-generation transapical JenaValve TAVI system (JenaValve Technology GmbH, Munich, Germany) in patients with aortic stenosis (AS). Between November 2011 and November 2012, a total of 28 patients received transapical TAVI using the JenaValve. Primary endpoint was a combined efficacy endpoint after 1 year, which included all-cause mortality after more than 30 days, failure of current therapy for AS requiring hospitalization for symptoms of valve-related cardiac decompensation or prosthetic heart valve dysfunction. Moreover, we analyzed secondary endpoints after 3 and 12 months including cardiovascular mortality; major stroke; and life-threatening, disabling, or major bleeding. Mean echocardiographic follow-up was 471.35 ± 102.72 days. Mean age was 80.43 ± 6.03 years and EuroSCORE II was 8.80 ± 7.21%. Successful implantation was accomplished in 100% (n = 28). Median transvalvular aortic mean pressure gradient was 44.5 mm Hg (interquartile range [IQR]: 34.5; 55.5) preoperatively, 12 mm Hg (IQR: 9; 16) postoperatively, and 11 mm Hg (IQR: 8; 16) after 1 year. After 12 months, no paravalvular leakage was seen in 52.38% of the patients and grade 1 paravalvular leakage was seen in 47.62% of the patients. There was no grade 2 or 3 leakage detected. Stroke, valve thrombosis or dislocation, myocardial infarction, or bleeding was also not observed. However, criteria for the combined efficacy endpoint after 1 year were met in five patients (17.86%). Thirty-day mortality was 14.29% (n = 4) and all-cause mortality after 1 year was 21.43% (n = 6). The JenaValve transapical TAVI system is a safe and feasible procedure with low peri- and postoperative complications and convincing midterm performance of the

The flaws in the detail of an observational study on transcatheter aortic valve implantation versus surgical aortic valve replacement in intermediate-risks patients.

PubMed

Barili, Fabio; Freemantle, Nick; Folliguet, Thierry; Muneretto, Claudio; De Bonis, Michele; Czerny, Martin; Obadia, Jean Francois; Al-Attar, Nawwar; Bonaros, Nikolaos; Kluin, Jolanda; Lorusso, Roberto; Punjabi, Prakash; Sadaba, Rafael; Suwalski, Piotr; Benedetto, Umberto; Böning, Andreas; Falk, Volkmar; Sousa-Uva, Miguel; Kappetein, Pieter A; Menicanti, Lorenzo

2017-06-01

The PARTNER group recently published a comparison between the latest generation SAPIEN 3 transcatheter aortic valve implantation (TAVI) system (Edwards Lifesciences, Irvine, CA, USA) and surgical aortic valve replacement (SAVR) in intermediate-risk patients, apparently demonstrating superiority of the TAVI and suggesting that TAVI might be the preferred treatment method in this risk class of patients. Nonetheless, assessment of the non-randomized methodology used in this comparison reveals challenges that should be addressed in order to elucidate the validity of the results. The study by Thourani and colleagues showed several major methodological concerns: suboptimal methods in propensity score analysis with evident misspecification of the propensity scores (PS; no adjustment for the most significantly different covariates: left ventricular ejection fraction, moderate-severe mitral regurgitation and associated procedures); use of PS quintiles rather than matching; inference on not-adjusted Kaplan-Meier curves, although the authors correctly claimed for the need of balancing score adjusting for confounding factors in order to have unbiased estimates of the treatment effect; evidence of poor fit; lack of data on valve-related death.These methodological flaws invalidate direct comparison between treatments and cannot support authors' conclusions that TAVI with SAPIEN 3 in intermediate-risk patients is superior to surgery and might be the preferred treatment alternative to surgery. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Effectiveness and Safety of Transcatheter Aortic Valve Implantation for Aortic Stenosis in Patients With "Porcelain" Aorta.

PubMed

Ramirez-Del Val, Fernando; Hirji, Sameer A; Yammine, Maroun; Ejiofor, Julius I; McGurk, Siobhan; Norman, Anthony; Shekar, Prem; Aranki, Sary; Bhatt, Deepak L; Shah, Pinak; Cohn, Lawrence H; Kaneko, Tsuyoshi

2018-01-01

Surgical aortic valve replacement (SAVR) in patients with porcelain aorta is considered a high-risk procedure. Hence, transcatheter aortic valve implantation (TAVI) is emerging as the intervention of choice. However, there is a paucity of data directly comparing TAVI with SAVR in patients with porcelain aorta. We compared outcomes of TAVI versus SAVR in high-risk patients with porcelain between March 2012 and June 2015. The TAVI group included 54 patients, whereas 130 SAVR patients with porcelain aorta were identified (operated on between 2004 and 2015). Both groups were matched 1:1 based on the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score with a 0.5% a priori caliper, resulting in 52 matched pairs. The mean STS-PROM was 7.3 ± 3.9 for both groups (p = 0.98), whereas mean age was 77.5 years for TAVI and 78.8 years for SAVR (p = 0.46). Compared with SAVR, TAVI patients had lower operative mortality (3.8% vs 17.3%; p = 0.052), significantly shorter median intensive care unit (40 vs 107 hours; p < 0.001) and hospital (5 vs. 7 days; p < 0.001) length of stay (LOS), but similar postoperative stroke rates (7.7% vs 11.5%; p = 0.74). One-year unadjusted survival was 81.7% (95% confidence interval [CI]: 69.8% to 93.5%) in the TAVI group versus 71.2% (95% CI: 61.0% to 85.1%) in the SAVR group, p = 0.093. Cox proportional hazard modeling identified preoperative chronic kidney disease (hazard ratio: 2.63 [95% CI: 1.03 to 6.70]; p = 0.043) and SAVR (hazard ratio: 2.641 [95% CI: 1.07 to 6.51]; p = 0.035) as significant predictors for decreased survival. Overall, TAVI was associated with reduced operative mortality, increased survival, and shorter intensive care unit and hospital length of stay compared with SAVR in patients with porcelain aorta. This study demonstrates that TAVI is a safe intervention in this high-risk population. Copyright © 2017 Elsevier Inc. All rights reserved.

1-Year Clinical Outcomes in Women After Transcatheter Aortic Valve Replacement: Results From the First WIN-TAVI Registry.

PubMed

Chieffo, Alaide; Petronio, Anna Sonia; Mehilli, Julinda; Chandrasekhar, Jaya; Sartori, Samantha; Lefèvre, Thierry; Presbitero, Patrizia; Capranzano, Piera; Tchetche, Didier; Iadanza, Alessandro; Sardella, Gennaro; Van Mieghem, Nicolas M; Meliga, Emanuele; Dumonteil, Nicholas; Fraccaro, Chiara; Trabattoni, Daniela; Mikhail, Ghada; Sharma, Samin; Ferrer, Maria Cruz; Naber, Christoph; Kievit, Peter; Baber, Usman; Snyder, Clayton; Sharma, Madhav; Morice, Marie Claude; Mehran, Roxana

2018-01-08

This study sought to examine the safety and performance of contemporary transcatheter aortic valve replacement (TAVR) in an exclusive all-women TAVR population, and to further investigate the potential impact of female sex-specific characteristics on composite 1-year clinical outcomes. Women comprise ≥50% patients undergoing TAVR. Several data have shown the noninferiority of TAVR compared with surgical aortic valve replacement for symptomatic significant aortic stenosis, but no study so far has been specifically powered to detect differences by sex. The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for significant aortic stenosis, across 18 sites in Europe and 1 site in the United States, between January 2013 and December 2015. The primary Valve Academic Research Consortium (VARC)-2 efficacy endpoint was a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction beyond 30 days. Secondary endpoints included composite 1-year death or stroke. Predictors of 1-year outcomes were determined using Cox regression methods. A total of 1,019 intermediate to high-risk women, with mean age 82.5 ± 6.3 years, mean European System for Cardiac Operative Risk Evaluation (EuroSCORE) I 17.8 ± 11.7% and mean Society of Thoracic Surgeons score 8.3 ± 7.4% were enrolled. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. The primary VARC-2 efficacy composite endpoint occurred in 111 (10.9%) patients beyond 30 days and in 167 (16.5%) patients at 1 year. The incidence of 1-year death or stroke was 13.9% (n = 141). Death occurred in 127 (12.5%) patients and stroke in 22 (2.2%) patients. Prior coronary revascularization (hazard ratio [HR]: 1.72; 95% confidence interval [CI]: 1.17 to 2.52; p = 0.006) and EuroSCORE I (HR: 1.02; 95% CI

Impact of Annular Size on Outcomes After Surgical or Transcatheter Aortic Valve Replacement.

PubMed

Deeb, G Michael; Chetcuti, Stanley J; Yakubov, Steven J; Patel, Himanshu J; Grossman, P Michael; Kleiman, Neal S; Heiser, John; Merhi, William; Zorn, George L; Tadros, Peter N; Petrossian, George; Robinson, Newell; Mumtaz, Mubashir; Gleason, Thomas G; Huang, Jian; Conte, John V; Popma, Jeffrey J; Reardon, Michael J

2018-04-01

This analysis evaluates the relationship of annular size to hemodynamics and the incidence of prosthesis-patient mismatch (PPM) in surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) patients. The CoreValve US Pivotal High Risk Trial, described previously, compared TAVR using a self-expanding valve with SAVR. Multislice computed tomography was used to categorize TAVR and SAVR subjects according to annular perimeter-derived diameter: large (≥26 mm), medium (23 to <26 mm), and small (<23 mm). Hemodynamics, PPM, and clinical outcomes were assessed. At all postprocedure visits, mean gradients were significantly lower for TAVR compared with SAVR in small and medium size annuli (p < 0.001). Annular size was significantly associated with mean gradient after SAVR, with small annuli having the highest gradients (p < 0.05 at all timepoints); gradients were similar across all annular sizes after TAVR. In subjects receiving SAVR, the frequency of PPM was significantly associated with annular size, with small annuli having the greatest incidence. No difference in PPM incidence by annular sizing was observed with TAVR. In addition, TAVR subjects had significantly less PPM than SAVR subjects in small and medium annuli (p < 0.001), with no difference in the incidence of PPM between TAVR and SAVR in large annuli (p = 0.10). Annular size has a significant effect on hemodynamics and the incidence of PPM in SAVR subjects, not observed in TAVR subjects. With respect to annular size, TAVR results in better hemodynamics and less PPM for annuli less than 26 mm and should be strongly considered when choosing a tissue valve for small and medium size annuli. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

A Retrospective Study of 1526 Cases of Transcatheter Occlusion of Patent Ductus Arteriosus

PubMed Central

Jin, Mei; Liang, Yong-Mei; Wang, Xiao-Fang; Guo, Bao-Jing; Zheng, Ke; Gu, Yan; Lyu, Zhen-Yu

2015-01-01

Background: Patent ductus arteriosus (PDA) is one of the most common congenital heart diseases and began to get treated by transcatheter occlusion since 1997 in China. Since then, several devices have been invented for occluding PDA. This study aimed to evaluate the technical feasibility, safety, and efficacy of transcatheter occlusion of PDA with different devices. Methods: One thousand five hundred and twenty-six patients (537 boys, 989 girls) with PDA from January 1997 to September 2014 underwent descending aortogram and transcatheter occlusion procedure. We retrospectively analyzed data of these patients, including gender, age, weight, size and morphology of PDA, and devices used in transcatheter occlusion, outcomes, and postoperational complications. Results: Median age and median weight were 4.0 years (range: 0.3–52.0 years old) and 15.3 kg (range: 4.5–91.0 kg), respectively. Mean ductal diameter, aortic ductal diameter, ductal length, and pulmonary artery pressure were 3.50 ± 2.15 mm, 10.08 ± 2.46 mm, 7.49 ± 3.02 mm, and 30.21 ± 17.28 mmHg, respectively. Morphology of PDA assessed by descending aortogram was of type A in 1428 patients, type B in 6 patients, type C in 79 patients, type D in 4 patients, and type E in 9 patients according to the classification of Krichenko. Of all the 1526 patients, 1497 patients underwent transcatheter PDA closure, among which 1492 were successful. Devices used were Amplatzer duct occluder I (ADO I, 1280, 85.8%), Cook detachable coils (116, 7.8%), ADO II (ADO II, 68, 4.6%), muscular VSD occluder (12, 0.8%), and Amplatzer vascular plug (16, 1.0%). Conclusions: Excellent occlusion rates with low complication rates were achieved with all devices regardless of PDA types. With transcatheter occlusion technique and devices developing, more patients with PDA can be treated with transcatheter closure both safely and efficiently. PMID:26315073

"Eight Days of Nightmares … " - Octogenarian Patients' Experiences of Postoperative Delirium after Transcatheter or Surgical Aortic Valve Replacement.

PubMed

Instenes, Irene; Gjengedal, Eva; Eide, Leslie S P; Kuiper, Karel K J; Ranhoff, Anette H; Norekvål, Tone M

2018-02-01

Surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) are increasingly performed in octogenarian patients with severe aortic stenosis (AS), including those with high surgical risk. Postoperative delirium (PD) is a common and serious complication in older patients, characterised by reduced awareness, change in consciousness, disturbance in logical thinking and hallucinations. To explore how octogenarian patients experienced PD, a qualitative study was conducted including five women and five men between 81 and 88 years. The incidence of PD was assessed for five days using the Confusion Assessment Method. Cognitive function was assessed preoperatively and at a 6-month follow-up using the Mini-Mental State Examination. In-depth interviews were conducted 6-12 months post-discharge, transcribed, and analysed using Giorgi's phenomenological method. Postoperative delirium experiences were grouped into six themes: "Like dreaming while awake", "Disturbed experiences of time", "Existing in a twilight zone", "Trapped in medical tubes", "Moving between different surroundings" and "Meeting with death and the deceased". For the first time, we show that octogenarian patients who undergo SAVR or TAVI have strong and distressing memories of their delirious state that can persist for up to 12 months later. These findings provide valuable new information that will likely improve delivery of health services and enhance professional and empathic care of octogenarians after SAVR and TAVI. Copyright © 2017 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

Quality of Life Outcomes after Transcatheter Aortic Valve Replacement in an Unselected Population. A Report from the STS/ACC TVT Registry™

PubMed Central

Arnold, Suzanne V.; Spertus, John A.; Vemulapalli, Sreekanth; Li, Zhuokai; Matsouaka, Roland A.; Baron, Suzanne J.; Vora, Amit N.; Mack, Michael J.; Reynolds, Matthew R.; Rumsfeld, John S.; Cohen, David J.

2017-01-01

Importance In clinical trials, transcatheter aortic valve replacement (TAVR) has been shown to improve symptoms and quality of life. As this technology moves into general clinical practice, it is critical to evaluate the health status outcomes among unselected patients treated with TAVR. Design/Participants Observational study of patients with severe aortic stenosis treated with TAVR in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry. Main Outcomes Disease-specific health status was assessed at baseline and at 30 days (n=31,636) and 1 year after TAVR (n=7,014) with the Kansas City Cardiomyopathy Questionnaire-overall summary score (KCCQ-OS; range 0–100 points). We examined factors associated with health status at 1 year after TAVR using multivariable linear regression, with adjustment for baseline health status and accounting for clustering of patients within sites. Results Mean baseline KCCQ-OS was 42.3±23.7, indicating substantial health status impairment. Surviving patients had, on average, large improvements in health status at 30 days that persisted to 1 year, with a mean improvement in the KCCQ-OS of 27.6 points at 30 days and 31.9 points at 1 year. Worse baseline health status, older age, higher ejection fraction, lung disease, home oxygen, lower mean aortic valve gradient, prior stroke, diabetes, pacemaker, atrial fibrillation, slower gait speed, and non-femoral access were associated with worse health status at 1 year. Overall, 62.3% of patients had a favorable outcome at 1 year (alive with reasonable quality of life [KCCQ-OS ≥60] and no significant decline [≥10 points] from baseline) with the lowest rates seen among patients with severe lung disease (51.4%), on dialysis (47.7%), or with very poor baseline health status (49.2%). Conclusion In a national, contemporary clinical practice cohort of unselected patients, we found that improvement in health status following TAVR was similar to that

Development of a Risk Score Based on Aortic Calcification to Predict 1-year Mortality After Transcatheter Aortic Valve Replacement.

PubMed

Lantelme, Pierre; Eltchaninoff, Hélène; Rabilloud, Muriel; Souteyrand, Géraud; Dupré, Marion; Spaziano, Marco; Bonnet, Marc; Becle, Clément; Riche, Benjamin; Durand, Eric; Bouvier, Erik; Dacher, Jean-Nicolas; Courand, Pierre-Yves; Cassagnes, Lucie; Dávila Serrano, Eduardo E; Motreff, Pascal; Boussel, Loic; Lefèvre, Thierry; Harbaoui, Brahim

2018-05-11

The aim of this study was to develop a new scoring system based on thoracic aortic calcification (TAC) to predict 1-year cardiovascular and all-cause mortality. A calcified aorta is often associated with poor prognosis after transcatheter aortic valve replacement (TAVR). A risk score encompassing aortic calcification may be valuable in identifying poor TAVR responders. The C 4 CAPRI (4 Cities for Assessing CAlcification PRognostic Impact) multicenter study included a training cohort (1,425 patients treated using TAVR between 2010 and 2014) and a contemporary test cohort (311 patients treated in 2015). TAC was measured by computed tomography pre-TAVR. CAPRI risk scores were based on the linear predictors of Cox models including TAC in addition to comorbidities and demographic, atherosclerotic disease and cardiac function factors. CAPRI scores were constructed and tested in 2 independent cohorts. Cardiovascular and all-cause mortality at 1 year was 13.0% and 17.9%, respectively, in the training cohort and 8.2% and 11.8% in the test cohort. The inclusion of TAC in the model improved prediction: 1-cm 3 increase in TAC was associated with a 6% increase in cardiovascular mortality and a 4% increase in all-cause mortality. The predicted and observed survival probabilities were highly correlated (slopes >0.9 for both cardiovascular and all-cause mortality). The model's predictive power was fair (AUC 68% [95% confidence interval [CI]: 64-72]) for both cardiovascular and all-cause mortality. The model performed similarly in the training and test cohorts. The CAPRI score, which combines the TAC variable with classical prognostic factors, is predictive of 1-year cardiovascular and all-cause mortality. Its predictive performance was confirmed in an independent contemporary cohort. CAPRI scores are highly relevant to current practice and strengthen the evidence base for decision making in valvular interventions. Its routine use may help prevent futile procedures. Copyright �

Outcome comparison of African-American and Caucasian patients with severe aortic stenosis subjected to transcatheter aortic valve replacement: a single-center experience.

PubMed

Minha, Sa'ar; Barbash, Israel M; Magalhaes, Marco A; Ben-Dor, Itsik; Okubagzi, Petros G; Pendyala, Lakshmana K; Satler, Lowell F; Pichard, Augusto D; Torguson, Rebecca; Waksman, Ron

2015-03-01

This study aimed to report the outcomes of African Americans (AAs) in the US undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). Compared to Caucasians, AAs are reported to have poorer outcomes from most cardiovascular diseases, including high complication rates after surgical aortic valve replacement. The outcomes of AAs undergoing TAVR are not well established. Consecutive patients who underwent TAVR were included in this analysis. Patients' baseline characteristics, procedural data, in-hospital- and long-term outcomes were recorded and a comparison was performed between the AA and Caucasian cohorts. In a cohort of 469 consecutive patients, 51 (10.8%) were AA and 345 (74.5%) were Caucasian. The remaining patients (n = 73; 15.3%) self-reported their race as "unknown" or were from other races. Most baseline characteristics were similar between the two groups except for less men (33.3 vs. 50.1%; P = 0.016), a lower mean left ventricular ejection fraction (48.85 ± 16.35 vs. 53.24 ± 13.41%; P = 0.04) and lower rates of atrial fibrillation in AAs (15.7 vs.45.4%; P < 0.001). TAVR procedures in AAs were less frequently performed as part of a clinical trial (60.8 vs. 76.8%; P = 0.014). Most procedural and periprocedural outcome parameters were similar save for a higher rate of hemodynamic instability and postoperative need for intubation in AAs (10.4 vs. 2.5%; P = 0.018 and 29.4 vs. 16.9%; P = 0.03, respectively). This did not translate into a difference in mortality between AAs and Caucasians (30-day mortality 9.8 vs. 9.9%; P = 0.99; 1-year mortality 19.6 vs. 24.3%; P = 0.458, respectively). Unlike with other cardiovascular interventions, this study demonstrates that AA patients referred for TAVR shared similar risks and outcomes when compared to a Caucasian population. © 2014 Wiley Periodicals, Inc.

Female-specific survival advantage from transcatheter aortic valve implantation over surgical aortic valve replacement: Meta-analysis of the gender subgroups of randomised controlled trials including 3758 patients.

PubMed

Panoulas, Vasileios F; Francis, Darrel P; Ruparelia, Neil; Malik, Iqbal S; Chukwuemeka, Andrew; Sen, Sayan; Anderson, Jonathan; Nihoyannopoulos, Petros; Sutaria, Nilesh; Hannan, Edward L; Samadashvili, Zaza; D'Errigo, Paola; Schymik, Gerhard; Mehran, Roxana; Chieffo, Alaide; Latib, Azeem; Presbitero, Patrizia; Mehilli, Julinda; Petronio, Anna Sonia; Morice, Marie-Claude; Tamburino, Corrado; Thyregod, Hans G H; Leon, Martin; Colombo, Antonio; Mikhail, Ghada W

2018-01-01

Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) is the first area of interventional cardiology where women are treated as often as men. In this analysis of the gender specific results of randomised controlled trials (RCTs) comparing TAVI with surgical aortic valve replacement (SAVR) we aimed to determine whether gender affects the survival comparison between TAVI and SAVR. We identified all RCTs comparing TAVI versus SAVR for severe AS and reporting 1 and/or 2year survival. Summary odds ratios (ORs) were obtained using a random-effects model. Heterogeneity was assessed using the Q statistic and I 2 . Four RCTs met the criteria, totalling 3758 patients, 1706 women and 2052 men. Amongst females, TAVI recipients had a significantly lower mortality than SAVR recipients, at 1year (OR 0.68; 95%CI 0.50 to 0.94) and at 2years (OR 0.74; 95%CI 0.58 to 0.95). Amongst males there was no difference in mortality between TAVI and SAVR, at 1year (OR 1.09; 95%CI 0.86 to 1.39) or 2years (OR 1.05; 95%CI 0.85 to 1.3). The difference in treatment effect between genders was significant at both 1year (p interaction =0.02) and 2years (p interaction =0.04). In women TAVI has a 26 to 31% lower mortality odds than SAVR. In men, there is no difference in mortality between TAVI and SAVR. Copyright © 2017 Elsevier B.V. All rights reserved.

Transcatheter aortic valve replacement and vascular complications definitions.

PubMed

Van Mieghem, Nicolas M; Généreux, Philippe; van der Boon, Robert M A; Kodali, Susheel; Head, Stuart; Williams, Matthew; Daneault, Benoit; Kappetein, Arie-Pieter; de Jaegere, Peter P; Leon, Martin B; Serruys, Patrick W

2014-03-20

Transcatheter aortic valve replacement (TAVR) requires large calibre catheters and is therefore associated with increased vascular complications. The aim of this study was to illustrate the impact of the different definitions of major vascular complications on their incidence and to underscore the importance of uniform reporting. We pooled dedicated databases of consecutive patients undergoing TAVR from two tertiary care facilities and looked for the incidence of major vascular complications using various previously reported definitions. The level of agreement (Kappa statistic) between the respective definitions and the Valve Academic Research Consortium (VARC) consensus definition of vascular complications was assessed. A total of 345 consecutive patients underwent transfemoral TAVR and were included in this analysis. A completely percutaneous access and closure technique was applied in 96% of cases. Arterial sheath size ranged between 18 and 24 Fr, the majority being 18 Fr (60%). Procedural success was reached in 94.5%. Depending on the definition used, major vascular complications occurred in 5.2-15.9% of patients. According to the VARC definitions, the rate of major and minor vascular complications was 9.0% and 9.6%, respectively. Major vascular complications according to VARC criteria demonstrated at least a substantial level of agreement with the SOURCE registry (k 0.80), the UK registry (k 0.82) the Italian registry (k 0.72) and "FRANCE" registry (k 0.70) definitions, compared to a moderate level of agreement with the definitions used in the German registry ( 0.47) and the 18 Fr Safety and Efficacy study (k 0.42). Minor complications according to VARC demonstrated a moderate agreement only with vascular complications using the German registry definition (k 0.54). Non-uniformity in how vascular complications are defined precludes any reliable comparison between previously reported TAVR registries. The VARC consensus document offers standardised endpoint

Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Stortecky, Stefan; Stefanini, Giulio G; Pilgrim, Thomas; Heg, Dik; Praz, Fabien; Luterbacher, Fabienne; Piccolo, Raffaele; Khattab, Ahmed A; Räber, Lorenz; Langhammer, Bettina; Huber, Christoph; Meier, Bernhard; Jüni, Peter; Wenaweser, Peter; Windecker, Stephan

2015-09-25

The Valve Academic Research Consortium (VARC) has proposed a standardized definition of bleeding in patients undergoing transcatheter aortic valve interventions (TAVI). The VARC bleeding definition has not been validated or compared to other established bleeding definitions so far. Thus, we aimed to investigate the impact of bleeding and compare the predictivity of VARC bleeding events with established bleeding definitions. Between August 2007 and April 2012, 489 consecutive patients with severe aortic stenosis were included into the Bern-TAVI-Registry. Every bleeding complication was adjudicated according to the definitions of VARC, BARC, TIMI, and GUSTO. Periprocedural blood loss was added to the definition of VARC, providing a modified VARC definition. A total of 152 bleeding events were observed during the index hospitalization. Bleeding severity according to VARC was associated with a gradual increase in mortality, which was comparable to the BARC, TIMI, GUSTO, and the modified VARC classifications. The predictive precision of a multivariable model for mortality at 30 days was significantly improved by adding the most serious bleeding of VARC (area under the curve [AUC], 0.773; 95% confidence interval [CI], 0.706 to 0.839), BARC (AUC, 0.776; 95% CI, 0.694 to 0.857), TIMI (AUC, 0.768; 95% CI, 0.692 to 0.844), and GUSTO (AUC, 0.791; 95% CI, 0.714 to 0.869), with the modified VARC definition resulting in the best predictivity (AUC, 0.814; 95% CI, 0.759 to 0.870). The VARC bleeding definition offers a severity stratification that is associated with a gradual increase in mortality and prognostic information comparable to established bleeding definitions. Adding the information of periprocedural blood loss to VARC may increase the sensitivity and the predictive power of this classification. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Long-Term Health Benefit of Transcatheter Aortic Valve Replacement in Patients With Chronic Lung Disease.

PubMed

Crestanello, Juan A; Popma, Jeffrey J; Adams, David H; Deeb, G Michael; Mumtaz, Mubashir; George, Barry; Huang, Jian; Reardon, Michael J

2017-11-27

This study sought to characterize the long-term effect of chronic lung disease (CLD) on mortality, clinical outcomes, quality of life, and health benefits after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis. The long-term effect of CLD after TAVR is unknown. Prevalence and severity of CLD was determined at baseline in high- and extreme-risk patients with aortic stenosis from the CoreValve US Pivotal Trial. Clinical outcomes and health status were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS). A favorable health benefit was defined as alive with a KCCQ-OS ≥60 and stability (<10-point decrease) or improvement in the KCCQ-OS from baseline. CLD was present in 55% (20% mild, 13% moderate, 22% severe) of the 1,030 patients studied. All-cause mortality was higher in patients with moderate and severe CLD at 1 year (19.6% mild, 28.1% moderate, 26.9% severe CLD vs. 19.2% non-CLD; p = 0.030) and 3 years (44.8% mild, 53.0% moderate, 51.9% severe vs. 37.7% non-CLD; p < 0.001). New York Heart Association functional class improved in more than 80% of patients with CLD at 1 and 3 years. All patients had a nearly 20-point improvement in KCCQ-OS at 1 and 3 years. However, only 43.3% of patients with CLD had a favorable health benefit at 1 year and 22.5% at 3 years. Moderate and severe CLD increases 1- and 3-year mortality after TAVR. Although functional status and quality of life were improved in CLD at 1 and 3 years after TAVR, a favorable health benefit was only achieved in selected patients. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Incidence, Prognostic Impact, and Predictive Factors of Readmission for Heart Failure After Transcatheter Aortic Valve Replacement.

PubMed

Durand, Eric; Doutriaux, Maxime; Bettinger, Nicolas; Tron, Christophe; Fauvel, Charles; Bauer, Fabrice; Dacher, Jean-Nicolas; Bouhzam, Najime; Litzler, Pierre-Yves; Cribier, Alain; Eltchaninoff, Hélène

2017-12-11

The aim of this study was to assess the incidence, prognostic impact, and predictive factors of readmission for congestive heart failure (CHF) in patients with severe aortic stenosis treated by transcatheter aortic valve replacement (TAVR). TAVR is indicated in patients with severe symptomatic aortic stenosis in whom surgery is considered high risk or is contraindicated. Readmission for CHF after TAVR remains a challenge, and data on prognostic and predictive factors are lacking. All patients who underwent TAVR from January 2010 to December 2014 were included. Follow-up was achieved for at least 1 year and included clinical and echocardiographic data. Readmission for CHF was analyzed retrospectively. This study included 546 patients, 534 (97.8%) of whom were implanted with balloon-expandable valves preferentially via the transfemoral approach in 87.8% of cases. After 1 year, 285 patients (52.2%) had been readmitted at least once, 132 (24.1%) for CHF. Patients readmitted for CHF had an increased risk for death (p < 0.0001) and cardiac death (p < 0.0001) compared with those not readmitted for CHF. On multivariate analysis, aortic mean gradient (hazard ratio [HR]: 0.88; 95% confidence interval [CI]: 0.79 to 0.99; p = 0.03), post-procedural blood transfusion (HR: 2.27; 95% CI: 1.13 to 5.56; p = 0.009), severe post-procedural pulmonary hypertension (HR: 1.04; 95% CI: 1.00 to 1.07; p < 0.0001), and left atrial diameter (HR: 1.47; 95% CI: 1.08 to 2.01; p = 0.02) were independently associated with CHF readmission at 1 year. Readmission for CHF after TAVR was frequent and was strongly associated with 1-year mortality. Low gradient, persistent pulmonary hypertension, left atrial dilatation, and transfusions were predictive of readmission for CHF. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Upper gastrointestinal bleeding following transcatheter aortic valve replacement: A retrospective analysis.

PubMed

Stanger, Dylan E; Abdulla, Alym H; Wong, Frank T; Alipour, Sina; Bressler, Brian L; Wood, David A; Webb, John G

2017-08-01

The aim of this study was to identify the incidence of upper gastrointestinal bleeding (UGIB) in the postprocedural period following transcatheter aortic valve replacement (TAVR). As TAVR moves into intermediate- and low-risk patients, it has become increasingly important to understand its extracardiac complications. The patient population undergoing TAVR have clinical and demographic characteristics that place them at significant risk of UGIB. Practical aspects of TAVR, including use of antithrombotic therapy, further increase risk of UGIB. A retrospective single-center evaluation of 841 patients who underwent TAVR between January 2005 and August 2014 was performed in conjunction with analysis of referral patterns to the gastroenterology service for UGIB at the same site. The overall risk of UGIB following TAVR was found to be 2.0% (n = 17/841). Additionally, the risk of UGIB in patients receiving triple antithrombotic therapy was found to be 10-fold greater than patients not receiving triple antithrombotic therapy (11.8% vs 1.0%). Endoscopy findings demonstrated five high-risk esophageal lesions including erosive esophageal ulcers, visible vessels at the GE junction, erosions at distal esophagus, and an actively bleeding esophageal ring that had been intubated through by the transesophageal echocardiography (TEE) probe. This large cohort study demonstrates that TAVR is associated with a moderate risk of severe UGIB. The results of this study suggest that patients on triple antithrombotic therapy are at highest risk for severe UGIB. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Thirty-day readmissions in surgical and transcatheter aortic valve replacement: A systematic review and meta-analysis.

PubMed

Danielsen, Stein Ove; Moons, Philip; Sandven, Irene; Leegaard, Marit; Solheim, Svein; Tønnessen, Theis; Lie, Irene

2018-05-17

The 30-day all-cause readmission rate after surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) vary substantially. We conducted a systematic review and meta-analysis to examine the overall incidence, causes, and risk factors of 30-day all-cause readmission rate after SAVR and TAVR. Eight medical research databases were searched; Cochrane, Medline, Embase, UpToDate, PROSPERO, National Guideline Clearinghouse, SweMed and Oria. We followed The Preferred Reporting Items for Systematic reviews and Meta-analysis (PRISMA) for this study. Thirty-three articles were included in the systematic review, 32 of which were appropriate for the meta-analysis. Overall, 17% (95% CI: 16-18%) of patients in the SAVR group, and 16% (95% CI: 15-18%) in the TAVR groups were readmitted within 30 days. Heart failure, arrhythmia, infection, and respiratory problems were the most frequent causes of all-cause readmission after SAVR and TAVR. Most frequent reported prior risk factors for all-cause readmission following TAVR were diabetes, chronic lung disease/chronic obstructive pulmonary disease, atrial fibrillation, kidney problems, and transapical approach/nonfemoral access. For SAVR, no risk factors for 30-day all-cause readmission were reported in the literature to date. In conclusion, the overall proportion of 30-day all-cause readmission after SAVR and TAVR are high. Interventions to prevent avoidable readmissions ought to be developed and implemented. Copyright © 2018 Elsevier B.V. All rights reserved.

High Risk Aortic Valve Replacement - The Challenges of Multiple Treatment Strategies with an Evolving Technology.

PubMed

Booth, K; Beattie, R; McBride, M; Manoharan, G; Spence, M; Jones, J M

2016-01-01

Deciding on the optimal treatment strategy for high risk aortic valve replacement is challenging. Transcatheter Aortic Valve implantation (TAVI) has been available in our centre as an alternative treatment modality for patients since 2008. We present our early experience of TAVI and SAVR (surgical Aortic Valve Replacement) in high risk patients who required SAVR because TAVI could not be performed. The database for Surgical aortic valve and Transcatheter aortic valve replacement referrals was interrogated to identify relevant patients. Survival to hospital discharge was 95.5% in the forty five patients who had SAVR when TAVI was deemed technically unsuitable. One year survival was 86%. Defining who is appropriate for TAVI or high risk SAVR is challenging and multidisciplinary team discussion has never been more prudent in this field of evolving technology with ever decreasing risks of surgery. The introduction of TAVI at our institution has seen a rise in our surgical caseload by approximately by 25%. Overall, the option of aortic valve intervention is being offered to more patients in general which is a substantial benefit in the treatment of aortic valve disease.

Atrial fibrillation in transcatheter aortic valve implantation patients: Incidence, outcome and predictors of new onset.

PubMed

Zweiker, David; Fröschl, Mario; Tiede, Stephanie; Weidinger, Paul; Schmid, Johannes; Manninger, Martin; Brussee, Helmut; Zweiker, Robert; Binder, Josepha; Mächler, Heinrich; Marte, Wolfgang; Maier, Robert; Luha, Olev; Schmidt, Albrecht; Scherr, Daniel

There is controversial evidence if atrial fibrillation (AF) alters outcome after transcatheter aortic valve implantation (TAVI). TAVI itself may promote new-onset AF (NOAF). We performed a single-center study including 398 consecutive patients undergoing TAVI. Before TAVI, patients were divided into a sinus rhythm (SR) group (n=226, 57%) and baseline AF group (n=172, 43%) according to clinical records and electrocardiograms. Furthermore, incidence and predictors of NOAF were recorded. Baseline AF patients had a significantly higher 1-year mortality than the baseline SR group (19.8% vs. 11.5%, p=0.02). NOAF occurred in 7.1% of patients with prior SR. Previous valve surgery was the only significant predictor of NOAF (HR 5.86 [1.04-32.94], p<0.05). NOAF was associated with higher rehospitalization rate (62.5 vs. 34.8%, p=0.04), whereas mortality was unaffected. This study shows that NOAF is associated with higher rates of rehospitalization but not mortality after TAVI. Overall, patients with pre-existing AF have higher mortality. Copyright © 2017 Elsevier Inc. All rights reserved.

Outcomes of Patients With Severe Chronic Lung Disease Who Are Undergoing Transcatheter Aortic Valve Replacement.

PubMed

Suri, Rakesh M; Gulack, Brian C; Brennan, J Matthew; Thourani, Vinod H; Dai, Dadi; Zajarias, Alan; Greason, Kevin L; Vassileva, Christina M; Mathew, Verghese; Nkomo, Vuyisile T; Mack, Michael J; Rihal, Charanjit S; Svensson, Lars G; Nishimura, Rick A; O'Gara, Patrick T; Holmes, David R

2015-12-01

In this study, we sought to determine the clinical outcomes after transcatheter aortic valve replacement (TAVR) among patients with chronic lung disease (CLD) and to evaluate the safety of transaortic versus transapical alternate access approaches in patients with varying severities of CLD. Clinical records for patients undergoing TAVR from 2011 to 2014 in The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were linked to Medicare hospital claims (n = 11,656). Clinical outcomes were evaluated across strata of CLD severity, and the risk-adjusted association between access route and post-TAVR mortality was determined among patients with severe CLD. In this cohort (median age, 84 years; 51.7% female), moderate to severe CLD was present in 27.7% (14.3%, moderate; 13.4%, severe). Compared with patients with no or mild CLD, patients with severe CLD had a higher rate of post-TAVR mortality to 1-year (32.3% versus 21.0%; adjusted hazard ratio [HR], 1.48; 95% confidence interval [CI], 1.31 to 1.66), as did those with moderate CLD (25.5%; adjusted HR, 1.16; 95% CI, 1.03 to 1.30). The adjusted rate of mortality was similar for transapical versus transaortic approaches to 1 year (adjusted HR, 1.17; 95% CI, 0.83 to 1.65). Moderate or severe CLD is associated with an increased risk of death to 1-year after TAVR, and among patients with severe CLD, the risk of death appears to be similar with either transapical or transaortic alternate-access approaches. Further study is necessary to understand strategies to mitigate risk associated with CLD and the long-term implications of these findings. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Incidence, Timing, and Predictors of Valve Hemodynamic Deterioration After Transcatheter Aortic Valve Replacement: Multicenter Registry.

PubMed

Del Trigo, Maria; Muñoz-Garcia, Antonio J; Wijeysundera, Harindra C; Nombela-Franco, Luis; Cheema, Asim N; Gutierrez, Enrique; Serra, Vicenç; Kefer, Joelle; Amat-Santos, Ignacio J; Benitez, Luis M; Mewa, Jumana; Jiménez-Quevedo, Pilar; Alnasser, Sami; Garcia Del Blanco, Bruno; Dager, Antonio; Abdul-Jawad Altisent, Omar; Puri, Rishi; Campelo-Parada, Francisco; Dahou, Abdellaziz; Paradis, Jean-Michel; Dumont, Eric; Pibarot, Philippe; Rodés-Cabau, Josep

2016-02-16

Scarce data exist on the incidence of and factors associated with valve hemodynamic deterioration (VHD) after transcatheter aortic valve replacement (TAVR). This study sought to determine the incidence, timing, and predictors of VHD in a large cohort of patients undergoing TAVR. This multicenter registry included 1,521 patients (48% male; 80 ± 7 years of age) who underwent TAVR. Mean echocardiographic follow-up was 20 ± 13 months (minimum: 6 months). Echocardiographic examinations were performed at discharge, at 6 to 12 months, and yearly thereafter. Annualized changes in mean gradient (mm Hg/year) were calculated by dividing the difference between the mean gradient at last follow-up and the gradient at discharge by the time between examinations. VHD was defined as a ≥10 mm Hg increase in transprosthetic mean gradient during follow-up compared with discharge assessment. The overall mean annualized rate of transprosthetic gradient progression during follow-up was 0.30 ± 4.99 mm Hg/year. A total of 68 patients met criteria of VHD (incidence: 4.5% during follow-up). The absence of anticoagulation therapy at hospital discharge (p = 0.002), a valve-in-valve (TAVR in a surgical valve) procedure (p = 0.032), the use of a 23-mm valve (p = 0.016), and a greater body mass index (p = 0.001) were independent predictors of VHD. There was a mild but significant increase in transvalvular gradients over time after TAVR. The lack of anticoagulation therapy, a valve-in-valve procedure, a greater body mass index, and the use of a 23-mm transcatheter valve were associated with higher rates of VHD post-TAVR. Further prospective studies are required to determine whether a specific antithrombotic therapy post-TAVR may reduce the risk of VHD. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Practical determination of aortic valve calcium volume score on contrast-enhanced computed tomography prior to transcatheter aortic valve replacement and impact on paravalvular regurgitation: Elucidating optimal threshold cutoffs.

PubMed

Bettinger, Nicolas; Khalique, Omar K; Krepp, Joseph M; Hamid, Nadira B; Bae, David J; Pulerwitz, Todd C; Liao, Ming; Hahn, Rebecca T; Vahl, Torsten P; Nazif, Tamim M; George, Isaac; Leon, Martin B; Einstein, Andrew J; Kodali, Susheel K

The threshold for the optimal computed tomography (CT) number in Hounsfield Units (HU) to quantify aortic valvular calcium on contrast-enhanced scans has not been standardized. Our aim was to find the most accurate threshold to predict paravalvular regurgitation (PVR) after transcatheter aortic valve replacement (TAVR). 104 patients who underwent TAVR with the CoreValve prosthesis were studied retrospectively. Luminal attenuation (LA) in HU was measured at the level of the aortic annulus. Calcium volume score for the aortic valvular complex was measured using 6 threshold cutoffs (650 HU, 850 HU, LA × 1.25, LA × 1.5, LA+50, LA+100). Receiver-operating characteristic (ROC) analysis was performed to assess the predictive value for > mild PVR (n = 16). Multivariable analysis was performed to determine the accuracy to predict > mild PVR after adjustment for depth and perimeter oversizing. ROC analysis showed lower area under the curve (AUC) values for fixed threshold cutoffs (650 or 850 HU) compared to thresholds relative to LA. The LA+100 threshold had the highest AUC (0.81), and AUC was higher than all studied protocols, other than the LA x 1.25 and LA + 50 protocols, where the difference approached statistical significance (p = 0.05, and 0.068, respectively). Multivariable analysis showed calcium volume determined by the LAx1.25, LAx1.5, LA+50, and LA+ 100 HU protocols to independently predict PVR. Calcium volume scoring thresholds which are relative to LA are more predictive of PVR post-TAVR than those which use fixed cutoffs. A threshold of LA+100 HU had the highest predictive value. Copyright © 2017 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

A gender based analysis of predictors of all cause death after transcatheter aortic valve implantation.

PubMed

Conrotto, Federico; D'Ascenzo, Fabrizio; Salizzoni, Stefano; Presbitero, Patrizia; Agostoni, Pierfrancesco; Tamburino, Corrado; Tarantini, Giuseppe; Bedogni, Francesco; Nijhoff, Freek; Gasparetto, Valeria; Napodano, Massimo; Ferrante, Giuseppe; Rossi, Marco Luciano; Stella, Pieter; Brambilla, Nedy; Barbanti, Marco; Giordana, Francesca; Grasso, Costanza; Biondi Zoccai, Giuseppe; Moretti, Claudio; D'Amico, Maurizio; Rinaldi, Mauro; Gaita, Fiorenzo; Marra, Sebastiano

2014-10-15

The impact of gender-related pathophysiologic features of severe aortic stenosis on transcatheter aortic valve implantation (TAVI) outcomes remains to be determined, as does the consistency of predictors of mortality between the genders. All consecutive patients who underwent TAVI at 6 institutions were enrolled in this study and stratified according to gender. Midterm all-cause mortality was the primary end point, with events at 30 days and at midterm as secondary end points. All events were adjudicated according to Valve Academic Research Consortium definitions. Eight hundred thirty-six patients were enrolled, 464 (55.5%) of whom were female. At midterm follow-up (median 365 days, interquartile range 100 to 516) women had similar rates of all-cause mortality compared with men (18.1% vs 22.6%, p = 0.11) and similar incidence of myocardial infarction and cerebrovascular accident. Gender did not affect mortality also on multivariate analysis. Among clinical and procedural features, glomerular filtration rate <30 ml/min/1.73 m(2) (hazard ratio [HR] 2.55, 95% confidence interval [CI] 1.36 to 4.79) and systolic pulmonary arterial pressure >50 mm Hg (HR 2.26, 95% CI 1.26 to 4.02) independently predicted mortality in women, while insulin-treated diabetes (HR 3.45, 95% CI 1.47 to 8.09), previous stroke (HR 3.42, 95% CI 1.43 to 8.18), and an ejection fraction <30% (HR 3.82, 95% CI 1.41 to 10.37) were related to mortality in men. Postprocedural aortic regurgitation was independently related to midterm mortality in the 2 groups (HR 11.19, 95% CI 3.3 to 37.9). In conclusion, women and men had the same life expectancy after TAVI, but different predictors of adverse events stratified by gender were demonstrated. These findings underline the importance of a gender-tailored clinical risk assessment in TAVI patients. Copyright © 2014 Elsevier Inc. All rights reserved.

Quantified degree of eccentricity of aortic valve calcification predicts risk of paravalvular regurgitation and response to balloon post-dilation after self-expandable transcatheter aortic valve replacement.

PubMed

Park, Jun-Bean; Hwang, In-Chang; Lee, Whal; Han, Jung-Kyu; Kim, Chi-Hoon; Lee, Seung-Pyo; Yang, Han-Mo; Park, Eun-Ah; Kim, Hyung-Kwan; Chiam, Paul T L; Kim, Yong-Jin; Koo, Bon-Kwon; Sohn, Dae-Won; Ahn, Hyuk; Kang, Joon-Won; Park, Seung-Jung; Kim, Hyo-Soo

2018-05-15

Limited data exist regarding the impact of aortic valve calcification (AVC) eccentricity on the risk of paravalvular regurgitation (PVR) and response to balloon post-dilation (BPD) after transcatheter aortic valve replacement (TAVR). We investigated the prognostic value of AVC eccentricity in predicting the risk of PVR and response to BPD in patients undergoing TAVR. We analyzed 85 patients with severe aortic stenosis who underwent self-expandable TAVR (43 women; 77.2±7.1years). AVC was quantified as the total amount of calcification (total AVC load) and as the eccentricity of calcium (EoC) using calcium volume scoring with contrast computed tomography angiography (CTA). The EoC was defined as the maximum absolute difference in calcium volume scores between 2 adjacent sectors (bi-partition method) or between sectors based on leaflets (leaflet-based method). Total AVC load and bi-partition EoC, but not leaflet-based EoC, were significant predictors for the occurrence of ≥moderate PVR, and bi-partition EoC had a better predictive value than total AVC load (area under the curve [AUC]=0.863 versus 0.760, p for difference=0.006). In multivariate analysis, bi-partition EoC was an independent predictor for the risk of ≥moderate PVR regardless of perimeter oversizing index. The greater bi-partition EoC was the only significant parameter to predict poor response to BPD (AUC=0.775, p=0.004). Pre-procedural assessment of AVC eccentricity using CTA as "bi-partition EoC" provides useful predictive information on the risk of significant PVR and response to BPD in patients undergoing TAVR with self-expandable valves. Copyright © 2017 Elsevier B.V. All rights reserved.

Forced diuresis with matched hydration in reducing acute kidney injury during transcatheter aortic valve implantation (Reduce-AKI): study protocol for a randomized sham-controlled trial

PubMed Central

2014-01-01

Background Acute kidney injury (AKI) is observed in up to 41% of patients undergoing transcatheter aortic valve implantation (TAVI) and is associated with increased risk for mortality. The aim of the present study is to evaluate whether furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system reduces AKI in patients undergoing TAVI. Methods/Design Reduce-AKI is a randomized sham-controlled study designed to examine the effect of an automated matched hydration system in the prevention of AKI in patients undergoing TAVI. Patients will be randomized in a 1:1 fashion to the RenalGuard system (active group) versus non-matched saline infusion (sham-controlled group). Both arms receive standard overnight saline infusion and N-acetyl cysteine before the procedure. Discussion The Reduce-AKI trial will investigate whether the use of automated forced diuresis with matched saline infusion is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVI. Trial registration Clinicaltrials.gov: NCT01866800, 30 April 30 2013. PMID:24986373

Assessment of valve haemodynamics, reverse ventricular remodelling and myocardial fibrosis following transcatheter aortic valve implantation compared to surgical aortic valve replacement: a cardiovascular magnetic resonance study

PubMed Central

Fairbairn, Timothy A; Steadman, Christopher D; Mather, Adam N; Motwani, Manish; Blackman, Daniel J; Plein, Sven; McCann, Gerry P; Greenwood, John P

2013-01-01

Objective To compare the effects of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) on aortic valve haemodynamics, ventricular reverse remodelling and myocardial fibrosis (MF) by cardiovascular magnetic resonance (CMR) imaging. Design A 1.5 T CMR scan was performed preoperatively and 6 months postoperatively. Setting University hospitals of Leeds and Leicester, UK. Patients 50 (25 TAVI, 25 SAVR; age 77±8 years) high-risk severe symptomatic aortic stenosis (AS) patients. Main outcome measures Valve haemodynamics, ventricular volumes, ejection fraction (EF), mass and MF. Results Patients were matched for gender and AS severity but not for age (80±6 vs 73±7 years, p=0.001) or EuroSCORE (22±14 vs 7±3, p<0.001). Aortic valve mean pressure gradient decreased to a greater degree post-TAVI compared to SAVR (21±8 mm Hg vs 35±13 mm Hg, p=0.017). Aortic regurgitation reduced by 8% in both groups, only reaching statistical significance for TAVI (p=0.003). TAVI and SAVR improved (p<0.05) left ventricular (LV) end-systolic volumes (46±18 ml/m2 vs 41±17 ml/m2; 44±22 ml/m2 vs32±6 ml/m2) and mass (83±20 g/m2 vs 65±15 g/m2; 74±11 g/m2 vs 59±8 g/m2). SAVR reduced end-diastolic volumes (92±19 ml/m2 vs 74±12 ml/m2, p<0.001) and TAVI increased EF (52±12% vs 56±10%, p=0.01). MF reduced post-TAVI (10.9±6% vs 8.5±5%, p=0.03) but not post-SAVR (4.2±2% vs 4.1±2%, p=0.98). Myocardial scar (p≤0.01) and baseline ventricular volumes (p<0.001) were the major predictors of reverse remodelling. Conclusions TAVI was comparable to SAVR at LV reverse remodelling and superior at reducing the valvular pressure gradient and MF. Future work should assess the prognostic importance of reverse remodelling and fibrosis post-TAVI to aid patient selection. PMID:23749779

Radiopaque Marker Addition During Aortic Root Replacement With the Use of a Freestyle Porcine Bioprosthesis.

PubMed

Crowley, Olivia M; Doty, John R

2017-07-01

Aortic root replacement is indicated for aortic root aneurysm, small aortic root, and most root abscesses. This report describes the placement of a radiopaque marker during aortic root replacement using a Freestyle porcine bioprosthesis. This marker is a useful landmark during fluoroscopy for transcatheter valve-in-valve aortic valve replacement in the event of bioprosthesis degeneration. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Comparison of 1-Year Outcome in Patients With Severe Aorta Stenosis Treated Conservatively or by Aortic Valve Replacement or by Percutaneous Transcatheter Aortic Valve Implantation (Data from a Multicenter Spanish Registry).

PubMed

González-Saldivar, Hugo; Rodriguez-Pascual, Carlos; de la Morena, Gonzalo; Fernández-Golfín, Covadonga; Amorós, Carmen; Alonso, Mario Baquero; Dolz, Luis Martínez; Solé, Albert Ariza; Guzmán-Martínez, Gabriela; Gómez-Doblas, Juan José; Jiménez, Antonio Arribas; Fuentes, María Eugenia; Gay, Laura Galian; Ortiz, Martin Ruiz; Avanzas, Pablo; Abu-Assi, Emad; Ripoll-Vera, Tomás; Díaz-Castro, Oscar; Osinalde, Eduardo P; Martínez-Sellés, Manuel

2016-07-15

The factors that influence decision making in severe aortic stenosis (AS) are unknown. Our aim was to assess, in patients with severe AS, the determinants of management and prognosis in a multicenter registry that enrolled all consecutive adults with severe AS during a 1-month period. One-year follow-up was obtained in all patients and included vital status and aortic valve intervention (aortic valve replacement [AVR] and transcatheter aortic valve implantation [TAVI]). A total of 726 patients were included, mean age was 77.3 ± 10.6 years, and 377 were women (51.8%). The most common management was conservative therapy in 468 (64.5%) followed by AVR in 199 (27.4%) and TAVI in 59 (8.1%). The strongest association with aortic valve intervention was patient management in a tertiary hospital with cardiac surgery (odds ratio 2.7, 95% confidence interval 1.8 to 4.1, p <0.001). The 2 main reasons to choose conservative management were the absence of significant symptoms (136% to 29.1%) and the presence of co-morbidity (128% to 27.4%). During 1-year follow-up, 132 patients died (18.2%). The main causes of death were heart failure (60% to 45.5%) and noncardiac diseases (46% to 34.9%). One-year survival for patients treated conservatively, with TAVI, and with AVR was 76.3%, 94.9%, and 92.5%, respectively, p <0.001. One-year survival of patients treated conservatively in the absence of significant symptoms was 97.1%. In conclusion, most patients with severe AS are treated conservatively. The outcome in asymptomatic patients managed conservatively was acceptable. Management in tertiary hospitals is associated with valve intervention. One-year survival was similar with both interventional strategies. Copyright © 2016 Elsevier Inc. All rights reserved.

Prosthesis-patient mismatch after transcatheter aortic valve implantation: impact of 2D-transthoracic echocardiography versus 3D-transesophageal echocardiography.

PubMed

da Silva, Cristina; Sahlen, Anders; Winter, Reidar; Bäck, Magnus; Rück, Andreas; Settergren, Magnus; Manouras, Aristomenis; Shahgaldi, Kambiz

2014-12-01

To investigate the role of 2D-transthoracic echocardiography (2D-TTE) and 3D-transesophageal echocardiography (3D-TEE) in the determination of aortic annulus size prior transcatheter aortic valve implantation (TAVI) and its' impact on the prevalence of patient prosthesis mismatch (PPM). Echocardiography plays an important role in measuring aortic annulus dimension in patients undergoing TAVI. This has great importance since it determines both eligibility for TAVI and selection of prosthesis type and size, and can be potentially important in preventing an inadequate ratio between the prosthetic valvular orifice and the patient's body surface area, concept known as prosthesis-patient mismatch (PPM). A total of 45 patients were studied pre-TAVI: 20 underwent 3D-TEE (men/women 12/8, age 84.8 ± 5.6) and 25 2D-TTE (men/women 9/16, age 84.4 ± 5.4) in order to measure aortic annulus diameter. The presence of PPM was assessed before hospital discharge and after a mean period of 3 months. Moderate PPM was defined as indexed aortic valve area (AVAi) ≤ 0.85 cm(2)/m(2) and severe PPM as AVAi < 0.65 cm(2)/m(2). Immediately post-TAVI, moderate PPM was present in 25 and 28 % of patients worked up using 3D-TEE and 2D-TTE respectively p value = n.s) and severe PPM occurred in 10 % of the patients who underwent 3D-TEE and in 20 % in those with 2D-TTE (p value = n.s). The echocardiographic evaluation 3 months post-TAVI showed 25 % moderate PPM in the 3D-TEE group compared with 24 % in the 2D-TTE group (p value = n.s) and no cases of severe PPM in the 3DTEE group comparing to 20 % in the 2D-TTE group (p = 0.032). Our results indicate a higher incidence of severe PPM in patients who performed 2DTTE compared to those performing 3DTEE prior TAVI. This suggests that the 3D technique should replace the 2DTTE analysis when investigating the aortic annulus diameter in patients undergoing TAVI.

Procedural Experience for Transcatheter Aortic Valve Replacement and Relation to Outcomes: The STS/ACC TVT Registry.

PubMed

Carroll, John D; Vemulapalli, Sreekanth; Dai, Dadi; Matsouaka, Roland; Blackstone, Eugene; Edwards, Fred; Masoudi, Frederick A; Mack, Michael; Peterson, Eric D; Holmes, David; Rumsfeld, John S; Tuzcu, E Murat; Grover, Frederick

2017-07-04

Transcatheter aortic valve replacement (TAVR) has been introduced into U.S. clinical practice with efforts to optimize outcomes and minimize the learning curve. The goal of this study was to assess the degree to which increasing experience during the introduction of this procedure, separated from other outcome determinants including patient and procedural characteristics, is associated with outcomes. The authors evaluated the association of hospital TAVR volume and patient outcomes for TAVR by using data from 42,988 commercial procedures conducted at 395 hospitals submitting to the Transcatheter Valve Therapy Registry from 2011 through 2015. Outcomes assessed included adjusted and unadjusted in-hospital major adverse events. Increasing site volume was associated with lower in-hospital risk-adjusted outcomes, including mortality (p < 0.02), vascular complications (p < 0.003), and bleeding (p < 0.001) but was not associated with stroke (p = 0.14). From the first case to the 400th case in the volume-outcome model, risk-adjusted adverse outcomes declined, including mortality (3.57% to 2.15%), bleeding (9.56% to 5.08%), vascular complications (6.11% to 4.20%), and stroke (2.03% to 1.66%). Vascular and bleeding volume-outcome associations were nonlinear with a higher risk of adverse outcomes in the first 100 cases. An association of procedure volume with risk-adjusted outcomes was also seen in the subgroup having transfemoral access. The initial adoption of TAVR into practice in the United States showed that increasing experience was associated with better outcomes. This association, whether deemed a prolonged learning curve or a manifestation of a volume-outcome relationship, suggested that concentrating experience in higher volume heart valve centers might be a means of improving outcomes. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All

TAVR and SAVR: Current Treatment of Aortic Stenosis.

PubMed

Hu, Patrick P

2012-01-01

Transcatheter aortic valve replacement (TAVR) was approved in the United States in late 2011, providing a critically needed alternative therapy for patients with severe aortic stenosis previously refused surgical aortic valve replacement (SAVR). Over 20,000 TAVR have been performed in patients worldwide since 2002 when Alain Cribier performed the first-in-man TAVR. This paper reviews the data from balloon expandable and self-expanding aortic stent valves as well as data comparing them with traditional surgical aortic valve replacement (SAVR). Complications using criteria established by the Valve Academic Research Consortium (VARC) are reviewed. Future challenges and possibilities are discussed and will make optimizing TAVR an important goal in the years to come.

TAVR and SAVR: Current Treatment of Aortic Stenosis

PubMed Central

Hu, Patrick P.

2012-01-01

Transcatheter aortic valve replacement (TAVR) was approved in the United States in late 2011, providing a critically needed alternative therapy for patients with severe aortic stenosis previously refused surgical aortic valve replacement (SAVR). Over 20,000 TAVR have been performed in patients worldwide since 2002 when Alain Cribier performed the first-in-man TAVR. This paper reviews the data from balloon expandable and self-expanding aortic stent valves as well as data comparing them with traditional surgical aortic valve replacement (SAVR). Complications using criteria established by the Valve Academic Research Consortium (VARC) are reviewed. Future challenges and possibilities are discussed and will make optimizing TAVR an important goal in the years to come. PMID:22952419

Apico-Aortic Conduit for severe aortic stenosis: Technique, applications, and systematic review

PubMed Central

Elmistekawy, Elsayed; Lapierre, Harry; Mesana, Thierry; Ruel, Marc

2010-01-01

Patients referred for aortic valve replacement are often elderly and may have increased surgical risk associated with ascending aortic calcification, left ventricular dysfunction, presence of coronary artery disease, previous surgery, and/or presence of several co-morbidities. Some of these patients may not be considered candidates for conventional surgery because of their high risk profile. While transcatheter aortic valve replacement constitutes a widely accepted alternative, some patients may not be eligible for this modality due to anatomic factors. Apico-Aortic Conduit (AAC) insertion (aortic valve bypass surgery) constitutes a possible option in those patients. Apico-Aortic Conduit is not a new technique, as it has been used for decades in both pediatric and adult populations. However, there is a resurging interest in this technique due to the expanding scope of elderly patients being considered for the treatment of aortic stenosis. Herein, we describe our surgical technique and provide a systematic review of recent publications on AAC insertion, reporting that there is continued use and several modifications of this technique, such as performing it through a small thoracotomy without the use of the cardiopulmonary bypass. PMID:23960619

European Society of Cardiology Council for Cardiology Practice worldwide survey of transcatheter aortic valve implantation beliefs and practices.

PubMed

Asteggiano, Riccardo; Bramlage, Peter; Richter, Dimitrios J

2018-04-01

Background Transcatheter aortic valve implantation (TAVI) continues to gain popularity in the management of patients with severe aortic stenosis (SAS). Distribution of resources to maximise appropriate use remains a priority. Design & methods To determine the current perceptions and behaviours regarding SAS patient management, an 18-point multiple-choice questionnaire was distributed to European Society of Cardiology (ESC) Council for Cardiology Practice (CCP) e-journal and/or electronic newsletter subscribers. Respondents to all questions were considered. Sub-analyses based on respondent age, practice setting and geographical location were performed. Results Of 1245 full respondents, 41.5% were aged ≥ 51 years, 22.7% were aged 41-50 years and 35.8% were aged ≤ 40 years. The majority were located in Europe (77.5%), followed by Asia/Oceania (11.6%), America (7.6%) and Africa (3.4%). In-hospital and out-of-hospital cardiologists accounted for 57.4% of and 28.5% of the sample, respectively, with the remainder being general practitioners/other. The majority of respondents (70.1%) claimed to diagnose between one and five cases of SAS per month. Free access to TAVI was reported by 41.2%, being less common for those aged ≤ 40 years (32.7%; p < 0.001), those located in Asia/Oceania, America and Africa (20.1%, 18.1% and 2.4%, respectively; p < 0.01 in each case) and in-hospital compared to out-of-hospital cardiologists (35.7% vs. 54.5%, respectively; p < 0.001). The most common reason for not referring a patient for an aortic valve intervention was assessment that the patient was high risk/non-operable (55.5%), followed by short life expectancy (30.5%). The most common reason for referring a patient for TAVI over surgical replacement was surgical risk score (56.9%). The most commonly perceived main complication of TAVI was stroke (28.9%), while the most frequently selected main benefit was improvement in quality of life (37.2%). A high

Successful treatment of pure aortic insufficiency with transapical implantation of the JenaValve.

PubMed

Bleiziffer, Sabine; Mazzitelli, Domenico; Nöbauer, Christian; Ried, Thomas; Lange, Rüdiger

2013-08-01

Transcatheter aortic valve implantation was predominantly developed for patients with severe calcified aortic stenosis, as most devices are designed to anchor within the native valve calcium. We report on a patient with pure insufficiency of a non-calcified aortic valve, in whom an anatomically oriented catheter valve was implanted successfully. The design of the prosthesis with position feelers engaging the native aortic valve leaflets proved to be suitable for the treatment of pure aortic insufficiency. Georg Thieme Verlag KG Stuttgart · New York.

Indication for percutaneous aortic valve implantation

PubMed Central

Akin, Ibrahim; Kische, Stephan; Rehders, Tim C.; Nienaber, Christoph A.; Rauchhaus, Mathias; Schneider, Henrik; Liebold, Andreas

2010-01-01

The incidence of valvular aortic stenosis has increased over the past decades due to improved life expectancy. Surgical aortic valve replacement is currently the only treatment option for severe symptomatic aortic stenosis that has been shown to improve survival. However, up to one third of patients who require lifesaving surgical aortic valve replacement are denied surgery due to high comorbidities resulting in a higher operative mortality rate. In the past such patients could only be treated with medical therapy or percutaneous aortic valvuloplasty, neither of which has been shown to improve mortality. With advances in interventional cardiology, transcatheter methods have been developed for aortic valve replacement with the goal of offering a therapeutic solution for patients who are unfit for surgical therapy. Currently there are two catheter-based treatment systems in clinical application (the Edwards SAPIEN aortic valve and the CoreValve ReValving System), utilizing either a balloon-expandable or a self-expanding stent platform, respectively. PMID:22371763

Elimination of Trans-coarctation Pressure Gradients Has No Impact on Left Ventricular Function or Aortic Shear Stress Post Intervention in Patients with Mild Coarctation

PubMed Central

Keshavarz-Motamed, Zahra; Nezami, Farhad Rikhtegar; Partida, Ramon A.; Nakamura, Kenta; Staziaki, Pedro Vinícius; Ben-Assa, Eyal; Ghoshhajra, Brian; Bhatt, Ami B.; Edelman, Elazer R.

2017-01-01

OBJECTIVES To investigate the impact of transcatheter intervention on left ventricular (LV) function and aortic hemodynamics in patients with mild coarctation of the aorta (COA). BACKGROUND The optimal method and timing of transcatheter intervention for COA remains unclear, especially when the severity of COA is mild (peak-to-peak trans-coarctation pressure gradient, PKdP < 20 mmHg). Debate rages regarding the risk/benefit ratio of intervention vs. long-term effects of persistent minimal gradient in this heterogeneous population with differing blood pressures, ventricular function and peripheral perfusion. METHODS We developed a unique computational fluid dynamics and lumped parameter modeling framework based on patient-specific hemodynamic input parameters and validated it against patient-specific clinical outcomes (pre- and post-intervention). We used clinically measured hemodynamic metrics and imaging of the aorta and the LV in thirty-four patients with mild COA to make these correlations. RESULTS Despite dramatic reduction in trans-coarctation pressure gradient (catheter and Doppler echocardiography pressure gradients reduced 75% and 47.3%,), there was only modest effect on aortic flow and no significant impact on aortic shear stress (maximum time-averaged wall shear stress in descending aorta was reduced 5.1%). In no patient did transcatheter intervention improve LV function (e.g., stroke work and normalized stroke work were reduced by only 4.48% and 3.9%). CONCLUSIONS Transcatheter intervention which successfully relieves mild COA pressure gradients does not translate to decrease myocardial strain. The effects of intervention were determined to the greatest degree by ventricular-vascular coupling hemodynamics, and provide a novel valuable mechanism to evaluate patients with COA which may influence clinical practice. PMID:27659574

Which way in? The Necessity of Multiple Approaches to Transcatheter Valve Therapy

PubMed Central

Bleiziffer, S.; Krane, M.; Deutsch, M.A.; Elhmidi, Y.; Piazza, N.; Voss, B.; Lange, R.

2013-01-01

TAVI (transcatheter aortic valve implantation) is a less invasive treatment of the stenotic aortic valve while avoiding midline sternotomy and cardiopulmonary bypass. A crimped biological valve on a self-expanding or balloon-expandable stent is inserted antegradely or retrogradely under fluoroscopy, and deployed on the beating heart. Among the worldwide TAVI programs, many different concepts have been established for the choice of the access site. Whether retrograde or antegrade TAVI should be considered the superior approach is matter of an ongoing debate. The published literature demonstrates safety of all techniques if performed within a dedicated multidisciplinary team. Since there is no data providing evidence if one approach is superior to another, we conclude that an individualized patient-centered decision making process is most beneficial, taking advantage of the complementarity of the different access options. The aim of this article is to give an overview of the current practice of access techniques for transcatheter based valve treatment and to outline the respective special characteristics. PMID:24313647

Transapical transcatheter aortic valve implantation using a new second-generation TAVI system - J-Valve™ for high-risk patients with aortic valve diseases: Initial results with 90-day follow-up.

PubMed

Zhu, Da; Chen, Yucheng; Guo, Yingqiang; Hu, Jia; Zhang, Ji; Wei, Xin; Tang, Hong; Shi, Yingkang

2015-11-15

To evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) for patients with aortic stenosis (AS) or pure/dominant aortic regurgitation (AR) using the J-Valve™ system. Twenty patients with isolated aortic valve disease (11 with pure/dominant AR and 9 with AS) at high risk for open-heart surgery were enrolled in this study. The mean Logistic Euro-SCORE I was 27.2±8.2% (mean age 74.5±4.7years). Four sizes of prosthesis were used for annular size up to 21 mm (n=1), 23mm (n=2), 25mm (n=10) and 27mm (n=7). Clinical and echocardiographic evaluations were performed at baseline, post-procedure and follow-up. The primary endpoint was all-cause mortality. Secondary endpoints were procedural success, major adverse events as well as echocardiographic performance. TAVI with the J-Valve™ device was successfully performed in 19 patients (95%). Conversion to surgical valve replacement was necessary in one patient due to prosthesis embolization. No mortality occurred during 90 days follow-up. Pacemaker implantation for new onset conduction disorders was necessary in one patient (5%). For patient with severe AS, post-procedure TAVI resulted in favorable reduction of mean transvalvular gradients (55.3±8.5 vs. 16.4±13.3 mmHg, P<0.01). Mean transvalvular gradient was also favorable in AR patients after valve implantation (6.9±1mmHg). The majority of patients had none or trivial paravalvular regurgitation (17/19) while none had moderate or severe paravalvular regurgitation. Trans-apical TAVI using the J-Valve™ prosthesis is potentially an effective treatment option for patients with AS or pure/dominant AR at high risk for open-heart surgery. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Trends and Outcomes of Transcatheter Aortic Valve Implantation (TAVI) in Korea: the Results of the First Cohort of Korean TAVI Registry

PubMed Central

2018-01-01

Background and Objectives There has been no nation-wide data on the outcomes of transcatheter aortic valve implantation (TAVI) after commercialization of TAVI in Korea. We report clinical features and outcomes of the first cohort of TAVI performed from Jun 2015 to Jun 2017 in Korea. Methods The first cohort of Korean-TAVI (K-TAVI) registry includes 576 consecutive patients with severe symptomatic aortic stenosis who underwent TAVI from 17 Korean hospitals for 2 years. Results Most of TAVI procedures were performed for septuagenarians and octogenarians (90.8%) through transfemoral approach (98.3%). The rate of device success was 92.5% and permanent pacemaker was implanted in 5.6%. In successive years, incidences of paravalvular leakage (PVL) and major bleeding declined. Society of Thoracic Surgeons (STS) score was 5.2 (3.0 to 9.0) and 34.7% of patients had high surgical risk (STS ≥8). One-year all-cause death occurred in 8.9% and was significantly lower in low to intermediate risk one than in high risk (5.4% vs. 15.5%, p<0.001). The independent predictors of 1-year mortality were age (hazard ratio [HR], 1.087; 95% confidence interval [CI], 1.036–1.141; p=0.001), moderate or severe PVL (HR, 4.631; 95% CI, 1.624–13.203; p=0.004) and end-stage renal disease (HR, 5.785; 95% CI, 2.717–12.316; p<0.001). Conclusions K-TAVI registry showed favorable 1-year outcomes with decreasing complication rate over time in real-world Korean patients. Two-thirds of patients were low to intermediate surgical risk and showed a significantly lower mortality than the high-risk patients, suggesting the promising future on the expanded indications of TAVI. PMID:29671283

Health Status Benefits of Transcatheter vs Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: Results From the PARTNER 2 Randomized Clinical Trial.

PubMed

Baron, Suzanne J; Arnold, Suzanne V; Wang, Kaijun; Magnuson, Elizabeth A; Chinnakondepali, Khaja; Makkar, Raj; Herrmann, Howard C; Kodali, Susheel; Thourani, Vinod H; Kapadia, Samir; Svensson, Lars; Brown, David L; Mack, Michael J; Smith, Craig R; Leon, Martin B; Cohen, David J

2017-08-01

In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results in similar 2-year survival. The effect of TAVR vs SAVR on health status in patients at intermediate surgical risk is unknown. To compare health-related quality of life among intermediate-risk patients with severe AS treated with either TAVR or SAVR. Between December 2011 and November 2013, 2032 intermediate-risk patients with severe AS were randomized to TAVR with the Sapien XT valve or SAVR in the Placement of Aortic Transcatheter Valve 2 Trial and were followed up for 2 years. Data analysis was conducted between March 1, 2016, to April 30, 2017. Health status was assessed at baseline, 1 month, 1 year, and 2 years using the Kansas City Cardiomyopathy Questionnaire (KCCQ) (23 items covering physical function, social function, symptoms, self-efficacy and knowledge, and quality of life on a 0- to 100-point scale; higher scores indicate better quality of life), Medical Outcomes Study Short Form-36 (36 items covering 8 dimensions of health status as well as physical and mental summary scores; higher scores represent better health status), and EuroQOL-5D (assesses 5 dimensions of general health on a 3-level scale, with utility scores ranging from 0 [death] to 1 [ideal health]). Analysis of covariance was used to examine changes in health status over time, adjusting for baseline status. Of the 2032 randomized patients, baseline health status was available for 1833 individuals (950 TAVR, 883 SAVR) who formed the primary analytic cohort. A total of 1006 (54.9%) of the population were men; mean (SD) age was 81.4 (6.8) years. Over 2 years, both TAVR and SAVR were associated with significant improvements in both disease specific (16-22 points on the KCCQ-OS scale) and generic health status (3.9-5.1 points on the SF-36 physical summary scale). At 1 month, TAVR was associated with better

Learning Curves Among All Patients Undergoing Transcatheter Aortic Valve Implantation in Germany: A Retrospective Observational Study.

PubMed

Kaier, Klaus; Reinecke, Holger; Schmoor, Claudia; Frankenstein, Lutz; Vach, Werner; Hehn, Philip; Zirlik, Andreas; Bode, Christoph; Zehender, Manfred; Reinöhl, Jochen

2017-05-15

Transcatheter aortic valve implantation (TAVI) is a rapidly evolving technique for therapy of aortic stenosis. Previous studies report learning curves with respect to in-hospital mortality and clinical complications. We aim to determine whether observed improvements of in-hospital outcomes after TAVI are the result of improvements in procedures or due to a change in the patient population, and whether improvements differ between the transfemoral (TF) and the transapical (TA) approach. Data was analyzed using risk-adjusted regression analyses in order to track the development of clinical outcomes of all isolated TAVI procedures performed in Germany from 2008 to 2013 (N=32.436) in all German hospitals performing TAVI. Measurements include in-hospital mortality, stroke, bleeding, and mechanical ventilation. Unadjusted mortality rates decrease over time for both TA-TAVI and TF-TAVI. Reductions in mortality were smaller for TA-TAVI than for TF-TAVI. These trends could also be observed for risk-adjusted (standardized) mortality rates, indicating that time trends and differences between TA-TAVI (around 7% in 2013) and TF-TAVI (around 4% in 2013) cannot be explained by changes in the risk factor composition of the patient populations. Bleeding complications decreased for both access routes. Both unadjusted and standardized bleeding rates were substantially higher for TA-TAVI. In addition, TA-TAVI procedures were associated with an increased likelihood of requiring >48h of mechanical ventilation. Observed improvements in TAVI-related in-hospital mortality are not due to a change in patient population. The results indicate the superiority of a TF-first approach. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

In vitro evaluation of flow patterns and turbulent kinetic energy in trans-catheter aortic valve prostheses.

PubMed

Giese, Daniel; Weiss, Kilian; Baeßler, Bettina; Madershahian, Navid; Choi, Yeong-Hoon; Maintz, David; Bunck, Alexander C

2018-02-01

The objective of the current work was to evaluate flow and turbulent kinetic energy in different transcatheter aortic valve implants using highly undersampled time-resolved multi-point 3-directional phase-contrast measurements (4D Flow MRI) in an in vitro setup. A pulsatile flow setup was used with a compliant tubing mimicking a stiff left ventricular outflow tract and ascending aorta. Five different implants were measured using a highly undersampled multi-point 4D Flow MRI sequence. Velocities and turbulent kinetic energy values were analysed and compared. Strong variations of turbulent kinetic energy distributions between the valves were observed. Maximum turbulent kinetic energy values ranged from 100 to over 500 J/m 3 while through-plane velocities were similar between all valves. Highly accelerated 4D Flow MRI for the measurement of velocities and turbulent kinetic energy values allowed for the assessment of hemodynamic parameters in five different implant models. The presented setup, measurement protocol and analysis methods provides an efficient approach to compare different valve implants and could aid future novel valve designs.

Transseptal antegrade transcatheter aortic valve replacement for patients with no other access approach - a contemporary experience.

PubMed

Cohen, Mauricio G; Singh, Vikas; Martinez, Claudia A; O'Neill, Brian P; Alfonso, Carlos E; Martinezclark, Pedro O; Heldman, Alan W; O'Neill, William W

2013-11-15

To assess the feasibility and outcomes in patients undergoing transvenous transseptal (TS) transcatheter aortic valve replacement (TAVR). TS approach for TAVR was abandoned in favor of retrograde transfemoral, transaortic, or transapical approaches. TS TAVR may still be warranted in patients for whom no other approach is feasible. Observational consecutive case series at a single center, to evaluate technical outcomes in inoperable patients with aortic stenosis who had contraindications for other approaches and who underwent TAVR via a transvenous TS antegrade approach using the Edwards-Sapien (ES) valve. Over a 4-month period, 9 patients underwent TS TAVR with 26 mm (n = 4) and 23 mm (n = 5) ES valves. Mean age was 84.5 ± 6.6 years and Society of Thoracic Surgeons predicted risk of mortality was 7.8 ± 2.8%. Specific contraindications for other access included iliofemoral arterial diameter <7 mm in 9 (100%), porcelain aorta in 6 (66%) patients, multiple (≥2) sternotomies in 2 (22%) patients, severe pulmonary disease in 3 (33%), extreme frailty in 1 (11%), spinal stenosis with impaired ability to rehabilitate postsurgery in 1 (11%) and apical left ventricular thrombus in 1 (11%) patient. Antegrade deployment of the ES prosthetic valve was technically feasible in 8 patients. Major bleeding occurred in 4 patients, two patients suffered acute kidney injury without need for dialysis and one patient required a permanent pacemaker. The median (25th, 75th percentiles) fluoroscopy time was 49 (34, 81) minutes and contrast volume was 150 (120, 225) ml. No patient had hemodynamically significant post-TAVR aortic insufficiency nor damage to the mitral valve. At 6 months follow-up, there were no cerebrovascular events or rehospitalizations and mean NYHA Class improved from 3.4 to 1.7. The antegrade TS approach to TAVR is a technically feasible option for "no-access" patients. Prospective assessment of the safety and efficacy of this approach in the current era warrants

Five-Year Outcomes of the First Pivotal Clinical Trial of Balloon-Expandable Transcatheter Aortic Valve Replacement in Japan (PREVAIL JAPAN).

PubMed

Sawa, Yoshiki; Takayama, Morimasa; Goto, Tsuyoshi; Takanashi, Shuichiro; Komiya, Tatsuhiko; Tobaru, Tetsuya; Maeda, Koichi; Kuratani, Toru; Sakata, Yasushi

2017-07-25

Transcatheter aortic valve replacement (TAVR) has been an alternative less invasive therapy for high-surgical risk/inoperable patients with aortic valve stenosis (AS) in Japan. We report 5-year outcomes of the first pivotal clinical trial of TAVR in Japan (PREVAIL JAPAN).Methods and Results:A total of 64 patients with AS who were considered unsuitable candidates for surgery were enrolled at 3 centers in Japan (mean age: 84.3±6.1 years, female: 65.6%, STS score: 9.0±4.5%). Transfemoral approach (TF) and transapical approach (TA) was performed in 37 patients and 27 patients, respectively. At 5 years, freedom from all-cause death was 52.7% (TF: 51.3%, TA: 56.3%). Risk of all stroke at 5-year was 15.8% (TF: 8.9%, TA: 25.5%) and risk of major adverse cardiac and cerebrovascular events at 5 years was 58.0% (TF: 51.3%, TA: 69.2%). Mild or greater aortic regurgitation (AR) at 1 week was not associated with increased all-cause death at 5 years (69.1%) compared with none or trace AR (48.3%) (P=0.184). Patients with high STS score (>8) had higher mortality rate than those with low STS scores (≤8). The 5-year data from PREVAIL JAPAN show the clinical benefit of TAVR and suggest that balloon-expandable TAVR is an effective treatment option for Japanese patients with severe AS who are not suitable for surgery. (Funded by Edwards Lifesciences Limited; ClinicalTrials.gov number, NCT01113983.).

Dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation.

PubMed

Ussia, Gian Paolo; Scarabelli, Marilena; Mulè, Massimiliano; Barbanti, Marco; Sarkar, Kunal; Cammalleri, Valeria; Immè, Sebastiano; Aruta, Patrizia; Pistritto, Anna Maria; Gulino, Simona; Deste, Wanda; Capodanno, Davide; Tamburino, Corrado

2011-12-15

Dual antiplatelet therapy (DAPT) with clopidogrel and aspirin is a widely accepted strategy in patients undergoing transcatheter aortic valve implantation (TAVI), but this approach is not evidence based. The goal of the present study was to determine whether DAPT in patients undergoing TAVI is associated with improved outcomes compared to aspirin alone. From May 2009 to August 2010, consecutive patients were randomized to receive a 300-mg loading dose of clopidogrel on the day before TAVI followed by a 3-month maintenance daily dose of 75 mg plus aspirin 100 mg lifelong (DAPT group) or aspirin 100 mg alone (ASA group). The primary end point was the composite of major adverse cardiac and cerebrovascular events, defined as death from any cause, myocardial infarction, major stroke, urgent or emergency conversion to surgery, or life-threatening bleeding. The cumulative incidence of major adverse cardiac and cerebrovascular events at 30 days and 6 months was 14% and 16%, respectively. No significant differences between the DAPT and ASA groups were noted at both 30 days (13% vs 15%, p = 0.71) and 6 months (18% vs 15%; p = 0.85). In conclusion, the strategy of adding clopidogrel to aspirin for 3 months after TAVI was not found to be superior to aspirin alone. These results must be confirmed in a larger randomized trial. Copyright © 2011 Elsevier Inc. All rights reserved.

A Meta-Analysis Examining Differences in Short-Term Outcomes Between Sutureless and Conventional Aortic Valve Prostheses.

PubMed

Hurley, Eoghan T; O'Sullivan, Katie E; Segurado, Ricardo; Hurley, John P

2015-01-01

Sutureless aortic valve prostheses are anchored by radial force in a mechanism similar to that of transcatheter aortic valve implantation. Transcatheter aortic valve implantation is associated with an increased permanent pacemaker (PPM) requirement in a significant proportion of patients. We undertook a meta-analysis to examine the incidence of PPM insertion associated with sutureless compared with conventional surgical aortic valve replacement. A systematic review was conducted in accordance with the Prisma guidelines. All searches were performed on August 10, 2014. Studies between 2007 and 2014 were included in the search. A total of 832 patients were included in the sutureless group and 3,740 in the conventional group. Aortic cross-clamp (39.8 vs 62.4 minutes; P < 0.001) and cardiopulmonary bypass (64.9 vs 86.7 minutes; P = 0.002) times were shorter in the sutureless group. Permanent pacemaker implantation rate was higher in the sutureless cohort (9.1% vs 2.4%; P = 0.025). Sutureless aortic valve prostheses are associated with significantly shorter cardiopulmonary bypass and aortic cross-clamp times and a higher incidence of PPM insertion than conventional. Further investigation of the prognostic significance is required.

Transcatheter aortic valve implantation and off-pump coronary artery bypass surgery: an effective hybrid procedure in selected patients.

PubMed

Mayr, Benedikt; Firschke, Christian; Erlebach, Magdalena; Bleiziffer, Sabine; Krane, Markus; Joner, Michael; Herold, Ulf; Nöbauer, Christian; Lange, Rüdiger; Deutsch, Marcus-André

2018-02-26

Simultaneous surgical off-pump coronary revascularization and transcatheter aortic valve implantation (TAVI) as a hybrid procedure may be a therapeutic option for patients with a TAVI indication who are not suitable for percutaneous coronary intervention and for patients who have an indication for combined surgical aortic valve implantation and coronary artery bypass grafting but present with a porcelain aorta. Early outcomes of these patients are analysed in this study. From February 2011 to April 2017, hybrid TAVI/off-pump coronary artery bypass (OPCAB) was performed in 12 (60%) patients, hybrid TAVI/minimally invasive direct coronary artery bypass in 6 (30%) patients and staged TAVI/OPCAB in 2 (10%) patients. Endpoints of this study were 30-day mortality, device success and postoperative adverse events as defined by the updated Valve Academic Research Consortium (VARC-2). The median age at the time of surgery was 77 years [interquartile range (IQR), 70-81] with a median logistic EuroSCORE and Society of Thoracic Surgeons' Predicted Risk score of 16.1% (IQR, 9.3-28.1) and 3.9% (IQR, 2.2-5.6), respectively. The median Synergy between PCI with Taxus and Cardiac Surgery score was 16.5 (IQR, 9.8-22.8). TAVI implantation routes were transaortic in 9 (45%) patients, transapical and transfemoral in 5 (25%) patients each and transsubclavian in 1 (5%) patient. Complete myocardial revascularization was achieved in 75% of patients. Device success rate was 100%. Paravalvular aortic regurgitation did not exceed mild in any patient. Stroke/transient ischaemic attack, vascular complications and myocardial infarction were not observed. Re-exploration for bleeding was required in 1 (5%) patient. Thirty-day mortality was 0%. Hybrid OPCAB/MIDCAB and TAVI prove to be a safe and effective alternative treatment option in selected higher risk patients.

Inverse Relationship Between Membranous Septal Length and the Risk of Atrioventricular Block in Patients Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Hamdan, Ashraf; Guetta, Victor; Klempfner, Robert; Konen, Eli; Raanani, Ehud; Glikson, Michael; Goitein, Orly; Segev, Amit; Barbash, Israel; Fefer, Paul; Spiegelstein, Dan; Goldenberg, Ilan; Schwammenthal, Ehud

2015-08-17

This study sought to examine whether imaging of the atrioventricular (AV) membranous septum (MS) by computed tomography (CT) can be used to identify patient-specific anatomic risk of high-degree AV block and permanent pacemaker (PPM) implantation before transcatheter aortic valve implantation (TAVI) with self-expandable valves. MS length represents an anatomic surrogate of the distance between the aortic annulus and the bundle of His and may therefore be inversely related to the risk of conduction system abnormalities after TAVI. Seventy-three consecutive patients with severe aortic stenosis underwent contrast-enhanced CT before TAVI. The aortic annulus, aortic valve, and AV junction were assessed, and MS length was measured in the coronal view. In 13 patients (18%), high-degree AV block developed, and 21 patients (29%) received a PPM. Multivariable logistic regression analysis revealed MS length as the most powerful pre-procedural independent predictor of high-degree AV block (odds ratio [OR]: 1.35, 95% confidence interval [CI]: 1.1 to 1.7, p = 0.01) and PPM implantation (OR: 1.43, 95% CI: 1.1 to 1.8, p = 0.002). When taking into account pre- and post-procedural parameters, the difference between MS length and implantation depth emerged as the most powerful independent predictor of high-degree AV block (OR: 1.4, 95% CI: 1.2 to 1.7, p < 0.001), whereas the difference between MS length and implantation depth and calcification in the basal septum were the most powerful independent predictors of PPM implantation (OR: 1.39, 95% CI: 1.2 to 1.7, p < 0.001 and OR: 4.9, 95% CI: 1.2 to 20.5, p = 0.03; respectively). Short MS, insufficient difference between MS length and implantation depth, and the presence of calcification in the basal septum, factors that may all facilitate mechanical compression of the conduction tissue by the implanted valve, predict conduction abnormalities after TAVI with self-expandable valves. CT assessment of membranous septal anatomy provides

The effect of X-ray beam distortion on the Edwards Sapien XT(™) trans-catheter aortic valve replacement prosthesis.

PubMed

Crowhurst, James A; Poon, Karl K; Murdoch, Dale; Incani, Alexander; Raffel, Owen C; Liddicoat, Annelise; Walters, Darren

2015-12-01

Profiling the Aortic root perpendicular to the fluoroscopic image plane will achieve a more successful implant position for trans-catheter aortic valve replacement (TAVR). This study aimed to investigate whether the divergent nature of the X-ray beam from the C-arm altered the appearance of the TAVR device. Under bench-top testing, a 23, 26 and 29 mm Edwards Sapien XT valve was positioned coaxially at the bottom of a fluoroscopic image utilising 22 and 32 cm fields of view (FOV). The table was then moved so that the valve was positioned at the top of the image. The valve's appearance was scored using a previously published three tier classification tool (excellent, satisfactory and poor) and quantified with measurements. The number of degrees of C-arm rotation that were required to bring the valve back to a coaxial appearance was recorded. When using the 32 cm FOV, the valve's appearance changes from excellent to satisfactory. When a 22 cm FOV was used, the change is less marked. More C-arm rotation is required to bring the appearance back to coaxial with the 32 cm FOV. Not maintaining the valve in the centre of the image can distort the valves appearance. This has the potential to affect the final implantation depth.

Self-expanding Portico Valve Versus Balloon-expandable SAPIEN XT Valve in Patients With Small Aortic Annuli: Comparison of Hemodynamic Performance.

PubMed

Del Trigo, María; Dahou, Abdellaziz; Webb, John G; Dvir, Danny; Puri, Rishi; Abdul-Jawad Altisent, Omar; Campelo-Parada, Francisco; Thompson, Chris; Leipsic, Jonathon; Stub, Dion; DeLarochellière, Robert; Paradis, Jean-Michel; Dumont, Eric; Doyle, Daniel; Mohammadi, Siamak; Pasian, Sergio; Côté, Melanie; Pibarot, Philippe; Rodés-Cabau, Josep

2016-05-01

The self-expanding Portico valve is a new transcatheter aortic valve system yielding promising preliminary results, yet there are no comparative data against earlier generation transcatheter aortic valve systems. The aim of this study was to compare the hemodynamic performance of the Portico and balloon-expandable SAPIEN XT valves in a case-matched study with echocardiographic core laboratory analysis. Twenty-two patients underwent transcatheter aortic valve implantation with the Portico 23-mm valve and were matched for aortic annulus area and mean diameter measured by multidetector computed tomography, left ventricular ejection fraction, body surface area, and body mass index with 40 patients treated with the 23-mm SAPIEN XT. Mean aortic annulus diameters were 19.6±1.3mm by transthoracic echocardiography and 21.4±1.2mm by computed tomography, with no significant between-group differences. Doppler echocardiographic images were collected at baseline and at 1-month of follow-up and were analyzed in a central echocardiography core laboratory. There were no significant between-group differences in residual mean transaortic gradients (SAPIEN XT: 10.4±3.7mmHg; Portico: 9.8±1.1mmHg; P=.49) and effective orifice areas (SAPIEN XT: 1.36±0.27cm(2); Portico, 1.37±.29cm(2); P=.54). Rates of severe prosthesis-patient mismatch (effective orifice area<0.65cm(2)/m(2)) were similar (SAPIEN XT: 13.5%; Portico: 10.0%; P=.56). No between-group differences were found in the occurrence of moderate-severe paravalvular leaks (5.0% vs 4.8% of SAPIEN XT and Portico respectively; P=.90). Transcatheter aortic valve implantation with the self-expanding Portico system yielded similar short-term hemodynamic performance compared with the balloon-expandable SAPIEN XT system for treating patients with severe aortic stenosis and small annuli. Further prospective studies with longer-term follow-up and in patients with larger aortic annuli are required. Copyright © 2015 Sociedad Española de

Aortic valve surgery of the 21st century: sutureless AVR versus TAVI.

PubMed

Costache, Victor S; Moldovan, Horatiu; Arsenescu, Catalina; Costache, Andreea

2018-04-01

Surgical aortic valve replacement (sAVR) has been a safe, effective and time-proven technique and is still the standard of care all over the world for aortic valve treatment. The vast majority of centers perform this procedure by doing a median sternotomy with several disadvantages. While many others specialties went minimally invasive decades ago, in cardiovascular field transcatheter valve implantation was the first minimally invasive valvular procedure that gained rapid worldwide acceptance. Transcatheter valve replacement (TAVR) is now marketed as a procedure that should be performed under local anesthesia, by an interventional cardiologist via trans femoral route with no other healthcare professional invited to the patient selection or case planning. An increasing number of surgeons are promoting minimally invasive aortic valve replacement, which is gaining grounds, especially with the help of the new sutureless valve technology. With these two new technologies emerging, legitimate questions arise and need to be answered - which has the longest durability, lower complication rate and lower overall mortality.

Local versus general anesthesia for transcatheter aortic valve implantation (TAVR)--systematic review and meta-analysis.

PubMed

Fröhlich, Georg M; Lansky, Alexandra J; Webb, John; Roffi, Marco; Toggweiler, Stefan; Reinthaler, Markus; Wang, Duolao; Hutchinson, Nevil; Wendler, Olaf; Hildick-Smith, David; Meier, Pascal

2014-03-10

The hypothesis of this study was that local anesthesia with monitored anesthesia care (MAC) is not harmful in comparison to general anesthesia (GA) for patients undergoing Transcatheter Aortic Valve Implantation (TAVR).TAVR is a rapidly spreading treatment option for severe aortic valve stenosis. Traditionally, in most centers, this procedure is done under GA, but more recently procedures with MAC have been reported. This is a systematic review and meta-analysis comparing MAC versus GA in patients undergoing transfemoral TAVR. Trials were identified through a literature search covering publications from 1 January 2005 through 31 January 2013. The main outcomes of interest of this literature meta-analysis were 30-day overall mortality, cardiac-/procedure-related mortality, stroke, myocardial infarction, sepsis, acute kidney injury, procedure time and duration of hospital stay. A random effects model was used to calculate the pooled relative risks (RR) with 95% confidence intervals. Seven observational studies and a total of 1,542 patients were included in this analysis. None of the studies were randomized. Compared to GA, MAC was associated with a shorter hospital stay (-3.0 days (-5.0 to -1.0); P = 0.004) and a shorter procedure time (MD -36.3 minutes (-58.0 to -15.0 minutes); P <0.001). Overall 30-day mortality was not significantly different between MAC and GA (RR 0.77 (0.38 to 1.56); P = 0.460), also cardiac- and procedure-related mortality was similar between both groups (RR 0.90 (0.34 to 2.39); P = 0.830). These data did not show a significant difference in short-term outcomes for MAC or GA in TAVR. MAC may be associated with reduced procedural time and shorter hospital stay. Now randomized trials are needed for further evaluation of MAC in the setting of TAVR.

Pathophysiological Factors Associated with Left Ventricular Perforation in Transcatheter Aortic Valve Implantation by Transfemoral Approach.

PubMed

Owais, Tamer; El Garhy, Mohammad; Fuchs, Jürgen; Disha, Kushtrim; Elkaffas, Sameh; Breuer, Martin; Lauer, Bernward; Kuntze, Thomas

2017-07-01

Left ventricular (LV) perforation is one of the rare and most serious complications of transcatheter aortic valve implantation (TAVI). The study aim was to determine the pathophysiological factors associated with this serious complication. A retrospective study was conducted of pathophysiological factors shown in echocardiograms and computed tomography angiograms performed preoperatively in patients who developed LV perforation during transfemoral TAVI (study group) with regards to anatomic and functional variables. Results were then compared with data acquired from a randomly selected sample of patients without perforation (control group). Among 963 TAVI cases, LV perforation occurred in 11 patients (three males, eight females; mean age 79 years). These patients showed complications of LV perforation that required emergency sternotomy and repair of injury to the left ventricle. Ten patients were rescued by the procedure, but one patient died during surgery. Focus on preoperative factors and intraoperative steps was established in favor to identify possible predictors of LV perforation. A LV cavity size <4.2 cm and a hypercontractile ventricle were identified in 10 patients (90%). Only one patient had a dilated cardiomyopathic left ventricle, with a cavity size of 6.1 cm and an ejection fraction of 10%. The present study results revealed other specific patient-related factors, namely a narrow aorto-mitral angle and a thin ventricular muscular wall despite long-standing aortic stenosis. All 11 patients had an average mid-LV muscular wall thickness of 5 mm. An inverse proportional relationship between the aorto-mitral angle and the incidence of perforation was noted, where in all 11 patients the wire had directed itself towards the anterior free wall of the left ventricle, where it induced injury. A small LV cavity, a hypercontractile state, a thin muscular wall, and a narrow aorto-mitral angle may be considered potential predictors of the occurrence of LV

Incidence and predictors of permanent pacemaker implantation following treatment with the repositionable Lotus™ transcatheter aortic valve.

PubMed

Zaman, Sarah; McCormick, Liam; Gooley, Robert; Rashid, Hashrul; Ramkumar, Satish; Jackson, Damon; Hui, Samuel; Meredith, Ian T

2017-07-01

To determine the incidence and predictors of permanent pacemaker (PPM) requirement following transcatheter aortic valve replacement (TAVR) with the mechanically expanded Lotus TM Valve System (Boston Scientific). Pacemaker implantation is the most common complication following TAVR. Predictors of pacing following TAVR with the Lotus valve have not been systematically assessed. Consecutive patients with severe aortic stenosis who underwent Lotus valve implantation were prospectively recruited at a single-centre. Patients with a pre-existing PPM were excluded. Baseline ECG, echocardiographic and multiple detector computed tomography as well as procedural telemetry and depth of implantation were independently analyzed in a blinded manner. The primary endpoint was 30-day incidence of pacemaker requirement (PPM implantation or death while pacing-dependent). Multivariate analysis was performed to identify independent predictors of the primary endpoint. A total of 104 consecutive patients underwent TAVR with the Lotus valve with 9/104 (9%) with a pre-existing PPM excluded. New or worsened procedural LBBB occurred in 78%. Thirty-day incidence of the primary pacing endpoint was 28%. The most common indication for PPM implantation was complete heart block (CHB) (69%). Independent predictors of the primary endpoint included pre-existing RBBB (hazard ratio [HR] 2.8, 95% CI 1.1-7.0; P = 0.032) and depth of implantation below the noncoronary cusp (NCC) (HR 2.4, 95% CI 1.0-5.7; P = 0.045). Almost a third of Lotus valve recipients require pacemaker implantation within 30 days. The presence of pre-existing RBBB and the depth of prosthesis implantation below the NCC were significant pacing predictors. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

The impact of waiting for intervention on costs and effectiveness: the case of transcatheter aortic valve replacement.

PubMed

Ribera, Aida; Slof, John; Ferreira-González, Ignacio; Serra, Vicente; García-Del Blanco, Bruno; Cascant, Purificació; Andrea, Rut; Falces, Carlos; Gutiérrez, Enrique; Del Valle-Fernández, Raquel; Morís-de laTassa, César; Mota, Pedro; Oteo, Juan Francisco; Tornos, Pilar; García-Dorado, David

2017-11-23

The economic crisis in Europe might have limited access to some innovative technologies implying an increase of waiting time. The purpose of the study is to evaluate the impact of waiting time on the costs and benefits of transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis. This is a cost-utility analysis from the perspective of the Spanish National Health Service. Results of two prospective hospital registries (158 and 273 consecutive patients) were incorporated into a probabilistic Markov model to compare quality adjusted life years (QALYs) and costs for TAVR after waiting for 3-12 months, relative to immediate TAVR. We simulated a cohort of 1000 patients, male, and 80 years old; other patient profiles were assessed in sensitivity analyses. As waiting time increased, costs decreased at the expense of lower survival and loss of QALYs, leading to incremental cost-effectiveness ratios for eliminating waiting lists of about 12,500 € per QALY. In subgroup analyses prioritization of patients for whom higher benefit was expected led to a smaller loss of QALYs. Concerning budget impact, long waiting lists reduced spending considerably and permanently. A shorter waiting time is likely to be cost-effective (considering commonly accepted willingness-to-pay thresholds in Europe) relative to 3 months or longer waiting periods. If waiting lists are nevertheless seen as unavoidable due to severe but temporary budgetary restrictions, prioritizing patients for whom higher benefit is expected appears to be a way of postponing spending without utterly sacrificing patients' survival and quality of life.

Effect of Serum C-Reactive Protein Level on Admission to Predict Mortality After Transcatheter Aortic Valve Implantation.

PubMed

Hioki, Hirofumi; Watanabe, Yusuke; Kozuma, Ken; Yamamoto, Masanori; Naganuma, Toru; Araki, Motoharu; Tada, Norio; Shirai, Shinichi; Yamanaka, Futoshi; Higashimori, Akihiro; Mizutani, Kazuki; Tabata, Minoru; Takagi, Kensuke; Ueno, Hiroshi; Hayashida, Kentaro

2018-04-12

The relation between C-reactive protein (CRP) level on admission and mortality after transcatheter aortic valve implantation (TAVI) remains unclear. To evaluate the impact of serum CRP level on mortality after TAVI, we assessed 1,016 patients with CRP who underwent TAVI and 538 patients with high-sensitive CRP (hs-CRP) level who underwent TAVI on admission in the OCEAN (Optimized Transcatheter Valvular Intervention)-TAVI registry. Study population was stratified into 2 groups (high/low), according to the median of CRP and hs-CRP on admission. We assessed the impact of high CRP and hs-CRP level on all-cause death after TAVI. During 2-year follow-up, all-cause death after TAVI was 9.4% in patients with CRP and 11.9% in patients with hs-CRP. Median value of serum CRP was 0.10 mg/dl in both CRP and hs-CRP. Patients with high CRP (>0.10 mg/dl) had significantly higher incidence of all-cause death compared with those with low CRP (11.5% vs 7.6%, log-rank p = 0.015). Multivariate Cox regression analysis with a time-varying covariate demonstrated that high CRP was an independent predictor of all-cause death within the first 3 months (hazard ratio 2.78, 95% CI 1.30 to 5.95) compared with from 3 months to 2 years (hazard ratio 0.80, 95% CI 0.47 to 1.36) (P for interaction = 0.008). Inversely, these results were not observed in the stratification using hs-CRP on admission. In conclusion, high CRP on admission was significantly associated with an increased risk of all-cause death after TAVI, particularly within the first 3 months after TAVI. Risk stratification using CRP may be a simple and useful strategy to identify high-risk patients who undergo TAVI. Copyright © 2018 Elsevier Inc. All rights reserved.

Multi-detector CT angiography of the aortic valve—Part 2: disease specific findings

PubMed Central

Ganeshan, Arul

2014-01-01

The aortic valve and adjacent structures should be routinely evaluated on all thoracic cross-sectional imaging studies. Echocardiography and magnetic resonance imaging (MRI) are the main imaging techniques used for assessment of the aortic valve and related pathology but multi-detector computed tomography (MDCT) can offer valuable complimentary information in some clinical scenarios. MDCT is the definite means of assessing aortic valvular calcification, acute aortic syndrome and for non-invasive assessment of the coronary arteries. MDCT also has an emerging role in the planning and follow-up of trans-catheter aortic valve replacement. This article reviews the spectrum of aortic valve disease highlighting the key MDCT imaging features. PMID:25202663

Ischemic Stroke in a Patient With Quadricuspid Aortic Valve and Patent Foramen Ovale.

PubMed

Spartalis, Michael; Tzatzaki, Eleni; Spartalis, Eleftherios; Damaskos, Christos; Moris, Demetrios; Tsiapras, Dimitrios; Voudris, Vassilis

2017-08-01

Quadricuspid aortic valve (QAV) is a rare congenital aortic valve abnormality. It is less common as compared to bicuspid or unicuspid aortic valve abnormality. QAV causes aortic regurgitation usually in the fifth to sixth decade of life. We present a rare case of a female patient with cryptogenic stroke due to a QAV and a patent foramen ovale (PFO). The patient underwent transcatheter closure of PFO, as there was no clear indication for surgery for her valve. Surgical removal remains the method of choice for the treatment of the QAV before left ventricular decompensation occurs.

Pre-procedural assessment of aortic annulus dimensions for transcatheter aortic valve replacement: comparison of a non-contrast 3D MRA protocol with contrast-enhanced cardiac dual-source CT angiography.

PubMed

Ruile, Philipp; Blanke, Philipp; Krauss, Tobias; Dorfs, Stephan; Jung, Bernd; Jander, Nikolaus; Leipsic, Jonathon; Langer, Mathias; Neumann, Franz-Josef; Pache, Gregor

2016-04-01

To evaluate the feasibility of a non-contrast three-dimensional (3D)-FLASH magnetic resonance angiography (MRA) protocol for pre-procedural aortic annulus assessment for transcatheter aortic valve replacement (TAVR) in comparison with cardiac dual-source computed tomography angiography (CTA). In this prospective study, 69 of 104 consecutive patients (mean age 81.8 ± 5.4 years, 37.7% arrhythmic) with severe aortic stenosis who had undergone pre-TAVR cardiac CTA received a respiratory and ECG-triggered, non-contrast 3D-FLASH MRA at 3 T. Annular area measurements were obtained at mid-diastole for both modalities whereas maximum systolic area was assessed by CTA only. Systolic MRA dimensions were modelled, by adding the relative difference of systolic and diastolic CTA area dimensions as a corrective factor. Hypothetical prosthesis sizing was performed based on systolic CTA, diastolic, and modelled systolic MRA area measurements. MR image quality and degree of annular calcifications were evaluated using 4-point-grading scales. The mean acquisition time was 14 ± 4.2 min. The mean image quality was 3.1 ± 0.9 with only two examinations rated non-diagnostic. The mean degree of calcifications was equal. As assessed by Bland-Altman analysis, there was no relevant systematic difference between area measurements for modelled systolic MRA and systolic CTA [the mean difference -3.1 mm(2) (limits of agreement -44.4 mm(2); 38.2 mm(2))]. Agreement for hypothetical prosthesis sizing was found in 63 of 67 (94%) patients for systolic CTA and modelled systolic MRA. The employed non-contrast 3D-FLASH MRA protocol allows for reliable assessment of aortic annulus dimensions and calcifications even in the presence of arrhythmias in an all-comers pre-TAVR population. Implementation of this technique appears legitimate in patients at an increased risk for contrast-induced nephropathy. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For

Association of Patient-Reported Health Status with Long-Term Mortality after Transcatheter Aortic Valve Replacement: A Report from the STS/ACC TVT Registry™

PubMed Central

Arnold, Suzanne V.; Spertus, John A.; Vemulapalli, Sreekanth; Dai, Dadi; O’Brien, Sean M.; Baron, Suzanne J.; Kirtane, Ajay J.; Mack, Michael J.; Green, Philip; Reynolds, Matthew R.; Rumsfeld, John S.; Cohen, David J.

2015-01-01

Background Although transcatheter aortic valve replacement (TAVR) is an effective treatment for aortic stenosis, long-term mortality after TAVR remains high and challenging to predict. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a health status measure, assessed directly from patients, that integrates two clinically relevant factors (symptoms and functional status) that may predict TAVR outcomes. Methods and Results Among 7769 patients from 286 sites in the STS-ACC TVT Registry, we examined the association between pre-procedure (baseline) patient health status, as assessed by the KCCQ, and 1-year mortality after TAVR. The KCCQ Overall Summary Score was categorized as very poor: <25, poor: 25–49, fair: 50–74, or good: ≥75. Prior to TAVR, health status was rated as very poor in 28%, poor in 38%, fair in 24%, and good in 10%. Patients with worse health status were more likely to be female and had more comorbidities and higher STS mortality risk scores. Compared with those with good health status prior to TAVR, and after adjusting for a broad range of baseline covariates, patients with very poor health status had a 2-fold increased hazard of death over the first year after TAVR (adjusted HR 2.00, 95% CI 1.58–2.54), while those with poor and fair health status had intermediate outcomes (adjusted HRs 1.54, 95% CI 1.22–1.95 and 1.20, 95% CI 0.94–1.55, respectively). Conclusions In a national, contemporary practice cohort, worse pre-procedure patient health status, as assessed by the KCCQ, was associated with greater long-term mortality after TAVR. These results support the measurement and integration of the KCCQ into mortality risk assessments for patients considering TAVR. PMID:26643740

Feasibility and outcomes of combined transcatheter aortic valve replacement with other structural heart interventions in a single session: a matched cohort study.

PubMed

Khattab, Ahmed A; Gloekler, Steffen; Sprecher, Beate; Shakir, Samera; Guerios, Enio; Stortecky, Stefan; O'Sullivan, Crochan J; Nietlispach, Fabian; Moschovitis, Aris; Pilgrim, Thomas; Buellesfeld, Lutz; Wenaweser, Peter; Windecker, Stephan; Meier, Bernhard

2014-01-01

Concurrent cardiac diseases are frequent among elderly patients and invite simultaneous treatment to ensure an overall favourable patient outcome. To investigate the feasibility of combined single-session percutaneous cardiac interventions in the era of transcatheter aortic valve implantation (TAVI). This prospective, case-control study included 10 consecutive patients treated with TAVI, left atrial appendage occlusion and percutaneous coronary interventions. Some in addition had patent foramen ovale or atrial septal defect closure in the same session. The patients were matched in a 1:10 manner with TAVI-only cases treated within the same time period at the same institution regarding their baseline factors. The outcome was validated according to the Valve Academic Research Consortium (VARC) criteria. Procedural time (126±42 vs 83±40 min, p=0.0016), radiation time (34±8 vs 22±12 min, p=0.0001) and contrast dye (397±89 vs 250±105 mL, p<0.0001) were higher in the combined intervention group than in the TAVI-only group. Despite these drawbacks, no difference in the VARC endpoints was evident during the in-hospital period and after 30 days (VARC combined safety endpoint 32% for TAVI only and 20% for combined intervention, p=1.0). Transcatheter treatment of combined cardiac diseases is feasible even in a single session in a high-volume centre with experienced operators.

The 'obesity paradox' does exist in patients undergoing transcatheter aortic valve implantation for aortic stenosis: a systematic review and meta-analysis.

PubMed

Lv, Wenyu; Li, Shuangjiang; Liao, Yanbiao; Zhao, Zhengang; Che, Guowei; Chen, Mao; Feng, Yuan

2017-10-01

Most recent studies have proposed the paradoxical benefits of obesity in surgical populations. For patients who underwent transcatheter aortic valve implantation (TAVI) for aortic stenosis, the prognostic roles of obesity and high body mass index remain controversial. Therefore, the objective of this meta-analysis was to evaluate whether the 'obesity paradox' exists in patients undergoing TAVI. We searched in PubMed and EMBASE to identify the eligible articles. Odds ratios and hazard ratios with the corresponding 95% confidence intervals (CI) were adopted for synthesizing short-term and long-term survival outcomes, respectively. The level of heterogeneity and the publication bias between studies were also estimated. Finally, there were 16 studies with 12 330 patients who met the eligibility criteria and who were thus included in this review. When body mass index was analysed as a continuous variable, each increase of 1 kg/m2 was significantly associated with the lower 30-day mortality rate (odds ratio = 0.95; 95% CI = 0.93-0.97; P < 0.001) and better long-term overall survival (hazard ratio = 0.96; 95% CI = 0.94-0.97; P < 0.001) for patients undergoing TAVI. The obese patients had a significantly lower risk of 30-day mortality after TAVI than did normal patients (odds ratio = 0.69; 95% CI = 0.50-0.95; P = 0.024). Further analyses indicated that the obesity could be predictive of more favourable long-term overall survival of TAVI (hazard ratio = 0.84; 95% CI = 0.72-0.97; P = 0.021). However, we found no difference in procedural complications between the obese and normal patients. In conclusion, higher body mass index and obesity seem to have protective benefits on both short-term and long-term survival of TAVI patients. Current evidence suggests that the 'obesity paradox' may really exist in TAVI. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio

Cardiac magnetic resonance versus transthoracic echocardiography for the assessment and quantification of aortic regurgitation in patients undergoing transcatheter aortic valve implantation.

PubMed

Ribeiro, Henrique B; Le Ven, Florent; Larose, Eric; Dahou, Abdellaziz; Nombela-Franco, Luis; Urena, Marina; Allende, Ricardo; Amat-Santos, Ignacio; Ricapito, Maria de la Paz; Thébault, Christophe; Clavel, Marie-Annick; Delarochelliére, Robert; Doyle, Daniel; Dumont, Eric; Dumesnil, Jean G; Pibarot, Philippe; Rodés-Cabau, Josep

2014-12-01

The transthoracic echocardiographic (TTE) evaluation of the severity of residual aortic regurgitation (AR) following transcatheter aortic valve implantation (TAVI) has been controversial and lacks validation. This study sought to compare TTE and cardiac magnetic resonance (CMR) for assessment of AR in patients undergoing TAVI with a balloon-expandable valve. TTE and CMR exams were performed pre-TAVI in 50 patients and were repeated postprocedure in 42 patients. All imaging data were analysed in centralised core laboratories. The severity of native AR as determined by multiparametric TTE approach correlated well with the regurgitant volume and regurgitant fraction determined by CMR prior to TAVI (Rs=0.79 and 0.80, respectively; p<0.001 for both). However, after TAVI, the correlation between the prosthetic AR severity assessed by TTE and regurgitant volume and fraction measured by CMR was only modest (Rs=0.59 and 0.59, respectively; p<0.001 for both), with an underestimation of AR severity by TTE in 61.9% of patients (1 grade in 59.5%). The TTE jet diameter in parasternal view and the multiparametric approach (Rs=0.62 and 0.59, respectively; both with p<0.001) showed the best correlation with CMR regurgitant fraction post-TAVI. The circumferential extent of prosthetic paravalvular regurgitation showed a poor correlation with CMR regurgitant volume and fraction (Rs=0.32, p=0.084; Rs=0.36, p=0.054, respectively). The severity of AR following TAVI with a balloon-expandable valve was underestimated by echocardiography as compared with CMR. The jet diameter, but not the circumferential extent of the leaks, and the multiparametric echocardiography integrative approach best correlated with CMR findings. These results provide important insight into the evaluation of AR severity post-TAVI. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Initial findings using the V8 hourglass-shaped valvuloplasty balloon for postdilatation in treating paravalvular leaks associated with transcatheter self-expanding aortic valve prosthesis.

PubMed

Latib, Azeem; Pedersen, Wesley; Maisano, Francesco; Lesser, John; Ruparelia, Neil; Figini, Filippo; Colombo, Antonio; Poulose, Anil; Kolbeck, James; Mooney, Michael; Schwartz, Robert; Youssef, Alicia; Ungs, David; Goldenberg, Irv; Sorajja, Paul

2016-06-01

The aim of this study was to assess the effect of a novel hourglass-shaped balloon on reduction of paravalvular leak (PVL) in patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding prostheses. An important limitation of TAVR compared with surgical aortic valve replacement remains the higher incidence of PVL. A commonly used strategy to treat PVL is balloon postdilatation (BPD); however, the optimal technique for treating PVL after TAVR is unknown. We examined consecutive patients with severe, symptomatic aortic stenosis who underwent TAVR with the Medtronic CoreValve followed by BPD with an InterValve V8 balloon for PVL grade ≥2+. Data from echocardiographic, multidetector computed tomographic, and angiographic images were reviewed. The primary endpoint was successful reduction in PVL to grade 1+ or less as assessed by intraprocedural echocardiography. Eleven patients were studied (median age, 82 years; 64% female). Ten patients (91%) demonstrated successful reduction in PVL after V8 BPD. In three patients, PVL was reduced to zero or trace. PVL remained unchanged in one patient (2+). Two patients had complete heart block associated with valve deployment and received permanent pacemakers. There were no occurrences of annular injury or major adverse clinical events. BPD with the V8 hourglass-shaped balloon was feasible in reducing PVL from self-expanding TAVR prostheses. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Advanced 3-D analysis, client-server systems, and cloud computing-Integration of cardiovascular imaging data into clinical workflows of transcatheter aortic valve replacement.

PubMed

Schoenhagen, Paul; Zimmermann, Mathis; Falkner, Juergen

2013-06-01

Degenerative aortic stenosis is highly prevalent in the aging populations of industrialized countries and is associated with poor prognosis. Surgical valve replacement has been the only established treatment with documented improvement of long-term outcome. However, many of the older patients with aortic stenosis (AS) are high-risk or ineligible for surgery. For these patients, transcatheter aortic valve replacement (TAVR) has emerged as a treatment alternative. The TAVR procedure is characterized by a lack of visualization of the operative field. Therefore, pre- and intra-procedural imaging is critical for patient selection, pre-procedural planning, and intra-operative decision-making. Incremental to conventional angiography and 2-D echocardiography, multidetector computed tomography (CT) has assumed an important role before TAVR. The analysis of 3-D CT data requires extensive post-processing during direct interaction with the dataset, using advance analysis software. Organization and storage of the data according to complex clinical workflows and sharing of image information have become a critical part of these novel treatment approaches. Optimally, the data are integrated into a comprehensive image data file accessible to multiple groups of practitioners across the hospital. This creates new challenges for data management requiring a complex IT infrastructure, spanning across multiple locations, but is increasingly achieved with client-server solutions and private cloud technology. This article describes the challenges and opportunities created by the increased amount of patient-specific imaging data in the context of TAVR.

Death and Dialysis After Transcatheter Aortic Valve Replacement: An Analysis of the STS/ACC TVT Registry.

PubMed

Hansen, James W; Foy, Andrew; Yadav, Pradeep; Gilchrist, Ian C; Kozak, Mark; Stebbins, Amanda; Matsouaka, Roland; Vemulapalli, Sreekanth; Wang, Alice; Wang, Dee Dee; Eng, Marvin H; Greenbaum, Adam B; O'Neill, William O

2017-10-23

The authors sought to elucidate the true incidence of renal replacement therapy (RRT) after transcatheter aortic valve replacement (TAVR). There is a wide discrepancy in the reported rate of RRT after TAVR (1.4% to 40%). The true incidence of RRT after TAVR is unknown. The STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) registry was linked to the Centers for Medicare & Medicaid database to identify all patients that underwent TAVR from November 2011 through September 2015 and their outcomes. The authors compared rates of death, new RRT, and a composite of both as a function of pre-procedure glomerular filtration rate (GFR), both in stages of chronic kidney disease (CKD), as well as on a continuous scale. Pre-procedure GFR is associated with the risk of death and new RRT after TAVR when GFR is <60 ml/min/m 2 , and increases significantly when GFR falls below 30 ml/min/m 2 . Incremental increases in GFR of 5 ml/min/m 2 were statistically significant (unadjusted hazard ratio: 0.71; p < 0.001) at 30 days, and continued to be significant at 1 year when pre-procedure GFR was <60 ml/min/m 2 . One in 3 CKD stage 4 patients will be dead within 1 year, with 14.6% (roughly 1 in 6) requiring dialysis. In CKD stage 5, more than one-third of patients will require RRT within 30 days; nearly two-thirds will require RRT at 1 year. In both unadjusted and adjusted analysis, pre-procedural GFR was associated with the outcomes of death and new RRT. Increasing CKD stage leads to an increased risk of death and/or RRT. Continuous analysis showed significant differences in outcomes in all levels of CKD when GFR was <60 ml/min/m 2 . Pre-procedure GFR should be considered when selecting CKD patients for TAVR. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Comparison of local versus general anesthesia in patients undergoing transcatheter aortic valve replacement: A meta-analysis.

PubMed

Villablanca, Pedro A; Mohananey, Divyanshu; Nikolic, Katarina; Bangalore, Sripal; Slovut, David P; Mathew, Verghese; Thourani, Vinod H; Rode's-Cabau, Josep; Núñez-Gil, Iván J; Shah, Tina; Gupta, Tanush; Briceno, David F; Garcia, Mario J; Gutsche, Jacob T; Augoustides, John G; Ramakrishna, Harish

2018-02-01

Transcatheter aortic valve replacement (TAVR) is typically performed under general anesthesia (GA). However, there is increasing data supporting the safety of performing TAVR under local anesthesia/conscious sedation (LA). We performed a meta-analysis to gain better understanding of the safety and efficacy of LA versus GA in patients with severe aortic stenosis undergoing TAVR. We comprehensively searched EMBASE, PubMed, and Web of Science. Effect sizes were summarized using risk ratios (RRs) difference of the mean (DM), and 95% CIs (confidence intervals) for dichotomous and continuous variables respectively. Twenty-six studies and 10,572 patients were included in the meta-analysis. The use of LA for TAVR was associated with lower overall 30-day mortality (RR, 0.73; 95% CI, 0.57-0.93; P = 0.01), use of inotropic/vasopressor drugs (RR, 0.45; 95% CI, 0.28-0.72; P < 0.001), hospital length of stay (LOS) (DM, -2.09; 95% CI, -3.02 to -1.16; P < 0.001), intensive care unit LOS (DM, -0.18; 95% CI, -0.31 to -0.04; P = 0.01), procedure time (DM, -25.02; 95% CI, -32.70 to -17.35; P < 0.001); and fluoroscopy time (DM, -1.63; 95% CI, -3.02 to -0.24; P = 0.02). No differences were observed between LA and GA for stroke, cardiovascular mortality, myocardial infarction, permanent pacemaker implantation, acute kidney injury, paravalvular leak, vascular complications, major bleeding, procedural success, conduction abnormalities, and annular rupture. Our meta-analysis suggests that use of LA for TAVR is associated with a lower 30-day mortality, shorter procedure time, fluoroscopy time, ICU LOS, hospital length of stay, and reduced need for inotropic support. © 2017 Wiley Periodicals, Inc.

Beyond adding years to life: health-related quality-of-life and functional outcomes in patients with severe aortic valve stenosis at high surgical risk undergoing transcatheter aortic valve replacement.

PubMed

Deutsch, Marcus-Andre; Bleiziffer, Sabine; Elhmidi, Yacine; Piazza, Nicolo; Voss, Bernhard; Lange, Ruediger; Krane, Markus

2013-11-01

Aortic valve stenosis (AVS) is the most frequent acquired valvular heart disease in western industrialized countries and its prevalence considerably increases with age. Once becoming symptomatic severe AVS has a very poor prognosis. Progressive and rapid symptom deterioration leads to an impairment of functional status and compromised healthrelated quality-of-life (HrQoL) simultaneously. Until recently, surgical aortic valve replacement (SAVR) has been the only effective treatment option for improving symptoms and prolonging survival. Transcatheter aortic valve replacement (TAVR) emerged as an alternative treatment modality for those patients with severe symptomatic AVS in whom the risk for SAVR is considered prohibitive or too high. TAVR has gained clinical acceptance with almost startling rapidity and has even quickly become the standard of care for the treatment of appropriately selected individuals with inoperable AVS during recent years. Typically, patients currently referred for and treated by TAVR are elderly with a concomitant variable spectrum of multiple comorbidities, disabilities and limited life expectancy. Beyond mortality and morbidity, the assessment of HrQoL is of paramount importance not only to guide patient-centered clinical decision-making but also to judge this new treatment modality. As per current evidence, TAVR significantly improves HrQoL in high-surgical risk patients with severe AVS with sustained effects up to two years when compared with optimal medical care and demonstrates comparable benefits relative to SAVR. Along with a provision of a detailed overview of the current literature regarding functional and HrQoL outcomes in patients undergoing TAVR, this review article addresses specific considerations of the HrQoL aspect in the elderly patient and finally outlines the implications of HrQoL outcomes for medico-economic deliberations.

[Cognitive and quality of life trajectory after either surgical or transcatheter aortic valve replacement in high-risk patients].

PubMed

Ciuca, Cristina; Fortuna, Daniela; Ferrari, Susy; Salizzoni, Stefano; Grisoglio, Enrica; Punta, Giuseppe; Del Ponte, Stefano; Aranzulla, Tiziana Claudia; Gabbieri, Davide; Gandolfo, Caterina; Dispensa, Flavia; Vecchio Verderame, Lavinia; Tamburino, Corrado; Caruso, Cinzia; Grossi, Claudio; Mikus, Elisa; Guiducci, Vincenzo; Violini, Roberto; Rongoni, Silvia; Pandolfi, Claudia; Moretti, Carolina; De Palma, Rossana; Chattat, Rabih; Savini, Carlo; Marzocchi, Antonio; Saia, Francesco

2016-12-01

The impact of transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (AVR) on cognitive status and quality of life in high-risk patients has been incompletely investigated. We conducted a prospective, multicenter study including all patients treated with TAVI and high-risk patients undergoing AVR (age ≥80 years or logistic EuroSCORE ≥15%) at participating centers. Multidimensional geriatric evaluation including Mini Mental State Examination (MMSE), EuroQol 5D (EQ5D) and Minnesota Living With Heart Failure Questionnaire (MLHFQ) were performed at baseline and at 3- and 12-month follow-up. A total of 518 patients (151 AVR and 367 TAVI) were enrolled in 10 Italian institutions. Patients receiving AVR were older (82.7 ± 2.4 years), with a lower logistic EuroSCORE (12.5 ± 7.1%) as compared with TAVI patients (81.5 ± 6.2 years and 19.6 ± 14.0%, respectively, p=0.001 and p<0.001). Overall, 35.5% of patients showed some degree of cognitive impairment at baseline, with no differences between groups. No significant changes in the cognitive status were observed between baseline and follow-up and between groups at any time point. TAVI patients had a lower quality of life at baseline as compared with AVR patients. Generic and heart failure-related quality of life improved significantly after either procedure. In high-risk patients, both TAVI and AVR are associated with a significant improvement of quality of life up to 1 year without a detrimental effect on cognitive function.

Transcatheter Embolization of Type I Endoleaks Associated With Endovascular Abdominal Aortic Aneurysm Repair Using Ethylene Vinyl Alcohol Copolymer.

PubMed

Graif, Assaf; Vance, Ansar Z; Garcia, Mark J; Lie, Kevin T; McGarry, Michael K; Leung, Daniel A

2017-01-01

To evaluate the feasibility, safety, and outcome of transcatheter embolization using ethylene vinyl alcohol copolymer (EVOH) of type I endoleaks associated with endovascular abdominal aortic aneurysm repair. Retrospective chart review was performed to identify 8 consecutive patients who had undergone EVOH embolization for type I endoleaks between 2012 and 2015. The primary approach used to access the endoleak was the perigraft technique, where the endoleak itself is catheterized at the anastomotic site. Six type Ia and 2 type Ib endoleaks were treated. In 2 patients, a direct transabdominal approach was used to access the endoleak because it was inaccessible via the perigraft approach. Coils were used in addition to EVOH in 5 cases. Residual endoleak was noted in 1 case, whereas 2 patients developed a recurrent type I endoleak during follow-up. No EVOH complications were observed. The 5 remaining patients demonstrated freedom from endoleak and reintervention at a mean follow-up of 6.9 months. Type I endoleaks can be safely and effectively treated by embolotherapy with EVOH. Larger endoleaks resulting from grossly undersized endografts appear to be unsuitable for EVOH embolization.

Mid-term study of transcatheter aortic valve implantation in an Asian population with severe aortic stenosis: two-year Valve Academic Research Consortium-2 outcomes

PubMed Central

Chew, Nicholas; Hon, Jimmy Kim Fatt; Yip, Wei Luen James; Chan, Siew Pang; Poh, Kian-Keong; Kong, William Kok-Fai; Teoh, Kristine Leok Kheng; Yeo, Tiong Cheng; Tan, Huay Cheem; Tay, Edgar Lik Wui

2017-01-01

INTRODUCTION Transcatheter aortic valve implantation (TAVI) is an effective treatment for high-risk or inoperative patients with severe aortic stenosis. Given the unique characteristics of Asian populations, questions regarding mid-term outcomes in Asians undergoing TAVI have yet to be addressed. We evaluated the two-year clinical outcomes of TAVI in an Asian population using Valve Academic Research Consortium-2 definitions. METHODS This prospective study recruited 59 patients from a major academic medical centre in Singapore. The main outcomes were two-year survival rates, peri-procedural complications, symptom improvement, valvular function and assessment of learning curve. RESULTS Mean age was 76.8 years (61.0% male), mean body surface area 1.6 m2 and mean logistic EuroSCORE 18.7%. Survival was 93.2%, 86.0% and 79.1% at 30 days, one year and two years, respectively. At 30 days post TAVI, the rate of stroke was 1.7%, life-threatening bleeding 5.1%, acute kidney injury 25.0%, major vascular complication 5.1%, and new permanent pacemaker implantation 6.8%. 29.3% of TAVI patients were rehospitalised (47.1% cardiovascular-related) within one year. These composite outcomes were measured: device success (93.2%); early safety (79.7%); clinical efficacy (66.1%); and time-related valve safety (84.7%). Univariate analysis found these predictors of two-year all-cause mortality: logistic EuroSCORE (hazard ratio [HR] 1.07; p < 0.001); baseline estimated glomerular filtration rate (HR 0.97; p = 0.048); and acute kidney injury (HR 5.33; p = 0.022). Multivariate analysis identified non-transfemoral TAVI as a predictor of cardiovascular-related two-year mortality (HR 14.64; p = 0.008). CONCLUSION Despite the unique clinical differences in Asian populations, this registry demonstrated favourable mid-term clinical and safety outcomes in Asians undergoing TAVI. PMID:27516113

Mid-term study of transcatheter aortic valve implantation in an Asian population with severe aortic stenosis: two-year Valve Academic Research Consortium-2 outcomes.

PubMed

Chew, Nicholas; Hon, Jimmy Kim Fatt; Yip, Wei Luen James; Chan, Siew Pang; Poh, Kian-Keong; Kong, William Kok-Fai; Teoh, Kristine Leok Kheng; Yeo, Tiong Cheng; Tan, Huay Cheem; Tay, Edgar Lik Wui

2017-09-01

Transcatheter aortic valve implantation (TAVI) is an effective treatment for high-risk or inoperative patients with severe aortic stenosis. Given the unique characteristics of Asian populations, questions regarding mid-term outcomes in Asians undergoing TAVI have yet to be addressed. We evaluated the two-year clinical outcomes of TAVI in an Asian population using Valve Academic Research Consortium-2 definitions. This prospective study recruited 59 patients from a major academic medical centre in Singapore. The main outcomes were two-year survival rates, peri-procedural complications, symptom improvement, valvular function and assessment of learning curve. Mean age was 76.8 years (61.0% male), mean body surface area 1.6 m 2 and mean logistic EuroSCORE 18.7%. Survival was 93.2%, 86.0% and 79.1% at 30 days, one year and two years, respectively. At 30 days post TAVI, the rate of stroke was 1.7%, life-threatening bleeding 5.1%, acute kidney injury 25.0%, major vascular complication 5.1%, and new permanent pacemaker implantation 6.8%. 29.3% of TAVI patients were rehospitalised (47.1% cardiovascular-related) within one year. These composite outcomes were measured: device success (93.2%); early safety (79.7%); clinical efficacy (66.1%); and time-related valve safety (84.7%). Univariate analysis found these predictors of two-year all-cause mortality: logistic EuroSCORE (hazard ratio [HR] 1.07; p < 0.001); baseline estimated glomerular filtration rate (HR 0.97; p = 0.048); and acute kidney injury (HR 5.33; p = 0.022). Multivariate analysis identified non-transfemoral TAVI as a predictor of cardiovascular-related two-year mortality (HR 14.64; p = 0.008). Despite the unique clinical differences in Asian populations, this registry demonstrated favourable mid-term clinical and safety outcomes in Asians undergoing TAVI. Copyright: © Singapore Medical Association

Ischemic Stroke in a Patient With Quadricuspid Aortic Valve and Patent Foramen Ovale

PubMed Central

Spartalis, Michael; Tzatzaki, Eleni; Spartalis, Eleftherios; Damaskos, Christos; Moris, Demetrios; Tsiapras, Dimitrios; Voudris, Vassilis

2017-01-01

Quadricuspid aortic valve (QAV) is a rare congenital aortic valve abnormality. It is less common as compared to bicuspid or unicuspid aortic valve abnormality. QAV causes aortic regurgitation usually in the fifth to sixth decade of life. We present a rare case of a female patient with cryptogenic stroke due to a QAV and a patent foramen ovale (PFO). The patient underwent transcatheter closure of PFO, as there was no clear indication for surgery for her valve. Surgical removal remains the method of choice for the treatment of the QAV before left ventricular decompensation occurs. PMID:28868103

Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond.

PubMed

Chakos, Adam; Wilson-Smith, Ashley; Arora, Sameer; Nguyen, Tom C; Dhoble, Abhijeet; Tarantini, Giuseppe; Thielmann, Matthias; Vavalle, John P; Wendt, Daniel; Yan, Tristan D; Tian, David H

2017-09-01

Transcatheter aortic valve implantation/replacement (TAVI/TAVR) is becoming more frequently used to treat aortic stenosis (AS), with increasing push for the procedure in lower risk patients. Numerous randomized controlled trials have demonstrated that TAVI offers a suitable alternative to the current gold standard of surgical aortic valve replacement (SAVR) in terms of short-term outcomes. The present review evaluates long-term outcomes following TAVI procedures. Literature search using three electronic databases was performed up to June 2017. Studies which included 20 or more patients undergoing TAVI procedures, either as a stand-alone or concomitant procedure and with a follow-up of at least 5 years, were included in the present review. Literature search and data extraction were performed by two independent researchers. Digitized survival data were extracted from Kaplan-Meier curves in order to re-create the original patient data using an iterative algorithm and subsequently aggregated for analysis. Thirty-one studies were included in the present analysis, with a total of 13,857 patients. Two studies were national registries, eight were multi-institutional collaborations and the remainder were institutional series. Overall, 45.7% of patients were male, with mean age of 81.5±7.0 years. Where reported, the mean Logistic EuroSCORE (LES) was 22.1±13.7 and the mean Society of Thoracic Surgeons (STS) score was 9.2±6.6. The pooled analysis found 30-day mortality, cerebrovascular accidents, acute kidney injury (AKI) and requirement for permanent pacemaker (PPM) implantation to be 8.4%, 2.8%, 14.4%, and 13.4%, respectively. Aggregated survival at 1-, 2-, 3-, 5- and 7-year were 83%, 75%, 65%, 48% and 28%, respectively. The present systematic review identified acceptable long-term survival results for TAVI procedures in an elderly population. Extended follow-up is required to assess long-term outcomes following TAVI, particularly before its application is extended into

Transcatheter Mitral Valve Replacement for Native and Failed Bioprosthetic Mitral Valves

PubMed Central

Sarkar, Kunal; Reardon, Michael J.; Little, Stephen H.; Barker, Colin M.; Kleiman, Neal S.

2017-01-01

Transcatheter mitral valve replacement (TMVR) is a novel approach for treatment of severe mitral regurgitation. A number of TMVR devices are currently undergoing feasibility trials using both transseptal and transapical routes for device delivery. Overall experience worldwide is limited to fewer than 200 cases. At present, the 30-day mortality exceeds 30% and is attributable to both patient- and device-related factors. TMVR has been successfully used to treat patients with degenerative mitral stenosis (DMS) as well as failed mitral bioprosthesis and mitral repair using transcatheter mitral valve-in-valve (TMViV)/valve-in-ring (ViR) repair. These patients are currently treated with devices designed for transcatheter aortic valve replacement. Multicenter registries have been initiated to collect outcomes data on patients currently undergoing TMViV/ViR and TMVR for DMS and have confirmed the feasibility of TMVR in these patients. However, the high periprocedural and 30-day event rates underscore the need for further improvements in device design and multicenter randomized studies to delineate the role of these technologies in patients with mitral valve disease. PMID:29743999

Robot-assisted real-time magnetic resonance image-guided transcatheter aortic valve replacement.

PubMed

Miller, Justin G; Li, Ming; Mazilu, Dumitru; Hunt, Tim; Horvath, Keith A

2016-05-01

Real-time magnetic resonance imaging (rtMRI)-guided transcatheter aortic valve replacement (TAVR) offers improved visualization, real-time imaging, and pinpoint accuracy with device delivery. Unfortunately, performing a TAVR in a MRI scanner can be a difficult task owing to limited space and an awkward working environment. Our solution was to design a MRI-compatible robot-assisted device to insert and deploy a self-expanding valve from a remote computer console. We present our preliminary results in a swine model. We used an MRI-compatible robotic arm and developed a valve delivery module. A 12-mm trocar was inserted in the apex of the heart via a subxiphoid incision. The delivery device and nitinol stented prosthesis were mounted on the robot. Two continuous real-time imaging planes provided a virtual real-time 3-dimensional reconstruction. The valve was deployed remotely by the surgeon via a graphic user interface. In this acute nonsurvival study, 8 swine underwent robot-assisted rtMRI TAVR for evaluation of feasibility. Device deployment took a mean of 61 ± 5 seconds. Postdeployment necropsy was performed to confirm correlations between imaging and actual valve positions. These results demonstrate the feasibility of robotic-assisted TAVR using rtMRI guidance. This approach may eliminate some of the challenges of performing a procedure while working inside of an MRI scanner, and may improve the success of TAVR. It provides superior visualization during the insertion process, pinpoint accuracy of deployment, and, potentially, communication between the imaging device and the robotic module to prevent incorrect or misaligned deployment. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Emergency extracorporeal membrane oxygenation in transcatheter aortic valve implantation: A two-center experience of incidence, outcome and temporal trends from 2010 to 2015.

PubMed

Trenkwalder, Teresa; Pellegrini, Costanza; Holzamer, Andreas; Philipp, Alois; Rheude, Tobias; Michel, Jonathan; Reinhard, Wibke; Joner, Michael; Kasel, Albert M; Kastrati, Adnan; Schunkert, Heribert; Endemann, Dierk; Debl, Kurt; Mayr, N Patrick; Hilker, Michael; Hengstenberg, Christian; Husser, Oliver

2017-11-11

Although the incidence of periprocedural complications has decreased in transcatheter aortic valve implantation (TAVI), life-threatening complications occur and emergency veno-arterial extracorporeal membrane oxygenation (vaECMO) can provide immediate circulatory stabilization. We report our two-center experience of vaECMO during life-threatening complications in TAVI. From January 2010 to December 2015, 1,810 consecutive patients underwent TAVI at two centers. Clinical characteristics, type of complication, outcome and temporal trends in the requirement of emergency vaECMO were evaluated. Life-threatening complications requiring vaECMO occurred in 1.8% of cases (33 patients; 22 transfemoral, 11 transapical). Indications for vaECMO were ventricular rupture (30%, 10/33), low output (15%, 5/33), bleeding (12%, 4/33), coronary artery impairment (9%, 3/33), ventricular arrhythmias (6%, 2/33), severe aortic regurgitation (6%, 2/33), aortic annular rupture (6%, 2/33), and aortic dissection (3%, 1/33). In 4 cases, no definite cause for hemodynamic instability was identified. Conversion to open heart surgery was necessary in 42% of patients (14/33). Percutaneous coronary intervention was performed in all cases with coronary artery impairment (9%, 3/33). Patients with severe aortic regurgitation (6%, 2/33) underwent emergency valve-in-valve implantation. Other patients received, in addition to vaECMO support conservative treatment (42%, 14/33). In-hospital mortality and 30-day mortality were 46% (15/33). Of patients discharged, 67% (12/18) had no neurological impairment, whereas mild and severe neurological impairment was found in 11% (2/18) and 22% (4/18), respectively. From 2010 to 2015, with increasing procedures (from n = 43 to n = 553) requirement of vaECMO decreased from 9.3% to 0.9% (P for the trend <0.001). Over a 6-year period, need for emergency vaECMO during TAVI significantly decreased over time. Despite high in-hospital mortality, vaECMO represents a

Is transcatheter aortic valve implantation (TAVI) a cost-effective treatment in patients who are ineligible for surgical aortic valve replacement? A systematic review of economic evaluations.

PubMed

Eaton, James; Mealing, Stuart; Thompson, Juliette; Moat, Neil; Kappetein, Pieter; Piazza, Nicolo; Busca, Rachele; Osnabrugge, Ruben

2014-05-01

Health Technology Assessment (HTA) agencies often undertake a review of economic evaluations of an intervention during an appraisal in order to identify published estimates of cost-effectiveness, to elicit comparisons with the results of their own model, and to support local reimbursement decision-making. The aim of this research is to determine whether Transcatheter Aortic Valve Implantation (TAVI) compared to medical management (MM) is cost-effective in patients ineligible for surgical aortic valve replacement (SAVR), across different jurisdictions and country-specific evaluations. A systematic review of the literature from 2007-2012 was performed in the MEDLINE, MEDLINE in-process, EMBASE, and UK NHS EED databases according to standard methods, supplemented by a search of published HTA models. All identified publications were reviewed independently by two health economists. The British Medical Journal (BMJ) 35-point checklist for economic evaluations was used to assess study reporting. To compare results, incremental cost effectiveness ratios (ICERs) were converted to 2012 dollars using purchasing power parity (PPP) techniques. Six studies were identified representing five reimbursement jurisdictions (England/Wales, Scotland, the US, Canada, and Belgium) and different modeling techniques. The identified economic evaluations represent different willingness-to-pay thresholds, discount rates, medical costs, and healthcare systems. In addition, the model structures, time horizons, and cycle lengths varied. When adjusting for differences in currencies, the ICERs ranged from $27K-$65K per QALY gained. Despite notable differences in modeling approach, under the thresholds defined by using either the local threshold value or that recommended by the World Health Organization (WHO) threshold value, each study showed that TAVI was likely to be a cost-effective intervention for patients ineligible for SAVR.

Inhospital and Post-discharge Changes in Renal Function After Transcatheter Aortic Valve Replacement.

PubMed

Blair, John E A; Brummel, Kent; Friedman, Julie L; Atri, Prashant; Sweis, Ranya N; Russell, Hyde; Ricciardi, Mark J; Malaisrie, S Chris; Davidson, Charles J; Flaherty, James D

2016-02-15

The aim of this study was to determine the influence of inhospital and post-discharge worsening renal function (WRF) on prognosis after transcatheter aortic valve replacement (TAVR). Severe chronic kidney disease and inhospital WRF are both associated with poor outcomes after TAVR. There are no data available on post-discharge WRF and outcomes. This was a single-center study evaluating all TAVR from June 1, 2008, to June 31, 2014. WRF was defined as an increase in serum creatinine of ≥0.3 mg/dl. Inhospital WRF was measured from day 0 until discharge or day 7 if the hospitalization was >7 days. Post-discharge WRF was measured at 30 days after discharge. Descriptive statistics, Kaplan-Meier time-to-event analysis, and multivariate logistic regression were used. In a series of 208 patients who underwent TAVR, 204 with complete renal function data were used in the inhospital analysis and 168 who returned for the 30-day follow-up were used in the post-discharge analysis. Inhospital WRF was seen in 28%, whereas post-discharge WRF in 12%. Inhospital and post-discharge WRF were associated with lower rates of survival; however, after multivariate analysis, only post-discharge WRF remained a predictor of 1-year mortality (hazard ratio 1.18, p = 0.030 for every 1 mg/dl increase in serum creatinine). In conclusion, the rate of inhospital WRF is higher than the rate of post-discharge WRF after TAVR, and post-discharge WRF is more predictive of mortality than inhospital WRF. Copyright © 2016 Elsevier Inc. All rights reserved.

Electrocardiographic Predictors of Long-Term Cardiac Pacing Dependency Following Transcatheter Aortic Valve Implantation.

PubMed

Naveh, Sivan; Perlman, Gidon Y; Elitsur, Yair; Planer, David; Gilon, Dan; Leibowitz, David; Lotan, Chaim; Danenberg, Haim; Alcalai, Ronny

2017-02-01

Conduction disorders requiring permanent pacemaker (PPM) implantation are a known complication of transcatheter aortic valve implantation (TAVI). Indications for permanent pacing in this setting are still controversial. The study aim was to characterize the natural history of conduction disorders related to TAVI, and to identify predictors for long-term pacing dependency. Consecutive patients who underwent TAVI were included in this prospective observational study. The conduction system was investigated by reviewing 12-lead ECGs during hospitalization and up to 1-year follow-up and by analyzing pacemaker interrogation data. Multivariate analysis was performed in order to identify independent predictors for pacemaker dependency. Of 110 patients included in the analysis, 38 (34.5%) underwent PPM implantation. Of those, 26 (68.4%) had a long-term pacing dependency (required PPM), while 12 (31.6%) did not (not-required PPM). Logistic regression revealed that baseline RBBB (P = 0.01, OR = 18.0), baseline PR interval (P = 0.019, OR = 1.14), post-TAVI PR interval and the change in PR interval from baseline (P < 0.001 for both, OR = 1.17 for each 10 milliseconds increment) were independent predictors for long-term pacing dependency. A PR interval increment of greater than 28 milliseconds had the best accuracy in predicting pacemaker dependency. Increased pre- and postprocedural PR intervals and pre-existing RBBB are reliable predictors for long-term PPM dependency, while left bundle branch block or QRS width are misleading factors. Our study suggests that the decision for implanting PPM after TAVI should be based mostly on the prolongation of the PR interval. © 2016 Wiley Periodicals, Inc.

Vascular Assessment for Transcatheter Aortic Valve Replacement: Intravascular Ultrasound Compared With Computed Tomography.

PubMed

Essa, Essa; Makki, Nader; Bittenbender, Peter; Capers, Quinn; George, Barry; Rushing, Gregory; Crestanello, Juan; Boudoulas, Konstantinos Dean; Lilly, Scott M

2016-12-01

Assessment of the femoral and iliac arteries is essential prior to transcatheter aortic valve replacement (TAVR). It is critical for establishing candidacy for a femoral approach, and can help predict vascular complications. Although computed tomography angiography (CTA) is the standard imaging modality, it has limitations. This study compared CTA with intravascular ultrasound (IVUS) in patients undergoing TAVR evaluation. Fifteen patients undergoing pre-TAVR coronary angiography and hemodynamic assessment were recruited. Following coronary angiography, patients underwent distal aortography, bilateral iliac and femoral arteriography, and IVUS assessment. Vascular tortuosity, minimum lumen diameter, and cross-sectional area were obtained and the findings were compared with those obtained from CTA. Correlation between IVUS and CTA was strong for minimum luminal diameter (r=0.62). Concordance was also strong between CTA and invasive iliofemoral angiography for assessment of tortuosity (r=0.75). Utilizing Bland-Altman analysis, vessel diameters obtained by IVUS were consistently greater than those obtained by CTA. The angiography and IVUS strategy was associated with a lower overall mean contrast utilization (29 cc vs 100 cc; P<.001), reduced mean radiation exposure (527 mGy vs 998 mGy; P=.045), and no significant difference in mean test duration (13.3 minutes vs 10 minutes; P=.12). For femoral and iliac arterial assessment prior to TAVR, IVUS is a viable alternative to CTA with comparable accuracy, and the potential for less contrast use and less radiation exposure. IVUS is also a valuable adjunct to CTA in patients with borderline femoral access diameters or considerable CTA artifacts.

Fluid-Structure Interaction Study of Transcatheter Aortic Valve Dynamics Using Smoothed Particle Hydrodynamics.

PubMed

Mao, Wenbin; Li, Kewei; Sun, Wei

2016-12-01

Computational modeling of heart valve dynamics incorporating both fluid dynamics and valve structural responses has been challenging. In this study, we developed a novel fully-coupled fluid-structure interaction (FSI) model using smoothed particle hydrodynamics (SPH). A previously developed nonlinear finite element (FE) model of transcatheter aortic valves (TAV) was utilized to couple with SPH to simulate valve leaflet dynamics throughout the entire cardiac cycle. Comparative simulations were performed to investigate the impact of using FE-only models vs. FSI models, as well as an isotropic vs. an anisotropic leaflet material model in TAV simulations. From the results, substantial differences in leaflet kinematics between FE-only and FSI models were observed, and the FSI model could capture the realistic leaflet dynamic deformation due to its more accurate spatial and temporal loading conditions imposed on the leaflets. The stress and the strain distributions were similar between the FE and FSI simulations. However, the peak stresses were different due to the water hammer effect induced by the fluid inertia in the FSI model during the closing phase, which led to 13-28% lower peak stresses in the FE-only model compared to that of the FSI model. The simulation results also indicated that tissue anisotropy had a minor impact on hemodynamics of the valve. However, a lower tissue stiffness in the radial direction of the leaflets could reduce the leaflet peak stress caused by the water hammer effect. It is hoped that the developed FSI models can serve as an effective tool to better assess valve dynamics and optimize next generation TAV designs.

Prognostic Impact of Calcium Score after Transcatheter Aortic Valve Implantation Performed With New Generation Prosthesis.

PubMed

Akodad, Mariama; Lattuca, Benoit; Agullo, Audrey; Macia, Jean-Christophe; Gandet, Thomas; Marin, Grégory; Iemmi, Anaïs; Vernhet, Hélène; Schmutz, Laurent; Nagot, Nicolas; Albat, Bernard; Cayla, Guillaume; Leclercq, Florence

2018-05-15

Calcium score (CS) is a well-known prognostic factor after transcatheter aortic valve implantation (TAVI) performed with first generation prosthesis but few data are available concerning new generation valves. The aim of this study was to evaluate if CS remains a prognostic factor after Sapien 3 and Evolut R valves implantation. Agatston CS was evaluated on multislice computed tomography before TAVI in 346 patients implanted with Sapien XT (n = 61), CoreValve (n = 57) devices, (group 1, n = 118), and with new generation Sapien 3 (n = 147), Evolut R (n = 81) prosthesis, (group 2, n = 228). Major adverse cardiovascular events and aortic regurgitation (AR) were evaluated at 1 month. The 2 groups were similar at baseline except for logistic Euroscore (20.1% in group 1 vs 15.0 % in group 2; p = 0.001), chronic renal failure (44.1% vs 37.2% respectively, p = 0.007) and preprocedural CS (4,092 ± 2,176 vs 3,682 ± 2,109 respectively, p = 0.022). In group 1, 28 patients (23.7%) had adverse clinical events vs 21 (9.2%) in group 2 (p <0.01). In multivariate analysis, a higher CS was predictive of adverse events in group 1 (5,785 ± 3,285 vs 3,565 ± 1,331 p <0.0001) but not in group 2 (p = 0.28). A higher CS was associated with AR in group 1 (6,234 ± 2711 vs 3,429 ± 1,505; p <0.001) and in patients implanted with an Evolut R device from group 2 (4,085 ± 3,645 vs 2,551 ± 1,356; p = 0.01). In conclusion, CS appears as an important prognostic factor of major events after TAVI with first generation valves but not with new generation devices. CS remains associated with AR only with new generation self-expandable Evolut R devices. Copyright © 2018 Elsevier Inc. All rights reserved.

Prognostic value of body mass index in transcatheter aortic valve implantation: A "J"-shaped curve.

PubMed

González-Ferreiro, Rocío; Muñoz-García, Antonio J; López-Otero, Diego; Avanzas, Pablo; Pascual, Isaac; Alonso-Briales, Juan H; Trillo-Nouche, Ramiro; Pun, Federico; Jiménez-Navarro, Manuel F; Hernández-García, José M; Morís, César; González Juanatey, José R

2017-04-01

We aimed to determine whether body mass index (BMI) is a prognostic indicator for long-term, all-cause mortality in patients undergoing transcatheter aortic valve implantation (TAVI). Obesity in patients with established cardiovascular disease has previously been identified as an indicator of good prognosis, a phenomenon known as the "obesity paradox". The prognostic significance of BMI in patients with severe aortic stenosis (AoS) undergoing TAVI is a matter of current debate, as published studies are scarce and their results conflicting. This is an observational, retrospective study involving 770 patients who underwent TAVI for AoS. The cohort was divided into three groups based on their BMI: normal weight (≥18.5 to <25kg/m 2 ), overweight (≥25 to <30kg/m 2 ) and obese (≥30kg/m 2 ). The predictive effect of BMI on all-cause mortality 3years following TAVI intervention was analysed using a Cox regression. 155 patients died during follow-up. The overweight group (n=302, 38.97%), experienced a lower mortality rate compared to the normal weight and obese groups (15.9% vs 25.7% and 21.0%, respectively [log-rank p-value=0.036]). After adjustment by logistic EuroSCORE, being overweight was found to be an independent protective factor against mortality (HR: 0.63 [95% CI: 0.42 to 0.94], p=0.024). This was not the case for obesity (HR: 0.92 [95% CI: 0.63 to 1.35], p=0.664). We therefore describe for the first time, a "J-shaped" regression curve describing the relationship between BMI and mortality. BMI is a predictive factor of all-cause mortality in AoS patients undergoing TAVI. This relationship takes the form of a "J-shaped" curve in which overweight patients are associated with the lowest mortality rate at follow-up. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The Fluid Mechanics of Transcatheter Heart Valve Leaflet Thrombosis in the Neosinus.

PubMed

Midha, Prem A; Raghav, Vrishank; Sharma, Rahul; Condado, Jose F; Okafor, Ikechukwu U; Rami, Tanya; Kumar, Gautam; Thourani, Vinod H; Jilaihawi, Hasan; Babaliaros, Vasilis; Makkar, Raj R; Yoganathan, Ajit P

2017-10-24

Transcatheter heart valve (THV) thrombosis has been increasingly reported. In these studies, thrombus quantification has been based on a 2-dimensional assessment of a 3-dimensional phenomenon. Postprocedural, 4-dimensional, volume-rendered CT data of patients with CoreValve, Evolut R, and SAPIEN 3 transcatheter aortic valve replacement enrolled in the RESOLVE study (Assessment of Transcatheter and Surgical Aortic Bioprosthetic Valve Dysfunction With Multimodality Imaging and Its Treatment with Anticoagulation) were included in this analysis. Patients on anticoagulation were excluded. SAPIEN 3 and CoreValve/Evolut R patients with and without hypoattenuated leaflet thickening were included to study differences between groups. Patients were classified as having THV thrombosis if there was any evidence of hypoattenuated leaflet thickening. Anatomic and THV deployment geometries were analyzed, and thrombus volumes were computed through manual 3-dimensional reconstruction. We aimed to identify and evaluate risk factors that contribute to THV thrombosis through the combination of retrospective clinical data analysis and in vitro imaging in the space between the native and THV leaflets (neosinus). SAPIEN 3 valves with leaflet thrombosis were on average 10% further expanded (by diameter) than those without (95.5±5.2% versus 85.4±3.9%; P <0.001). However, this relationship was not evident with the CoreValve/Evolut R. In CoreValve/Evolut Rs with thrombosis, the thrombus volume increased linearly with implant depth ( R 2 =0.7, P <0.001). This finding was not seen in the SAPIEN 3. The in vitro analysis showed that a supraannular THV deployment resulted in a nearly 7-fold decrease in stagnation zone size (velocities <0.1 m/s) when compared with an intraannular deployment. In addition, the in vitro model indicated that the size of the stagnation zone increased as cardiac output decreased. Although transcatheter aortic valve replacement thrombosis is a multifactorial process

Clinical Impact of Diabetes Mellitus on Outcomes After Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

PubMed

Abramowitz, Yigal; Vemulapalli, Sreekanth; Chakravarty, Tarun; Li, Zhuokai; Kapadia, Samir; Holmes, David; Matsouaka, Roland A; Wang, Alice; Cheng, Wen; Forrester, James S; Smalling, Richard; Thourani, Vinod; Mack, Michael; Leon, Martin; Makkar, Raj R

2017-11-01

Diabetes mellitus (DM) adversely affects morbidity and mortality for cardiovascular diseases and procedures. Data evaluating the outcomes of transcatheter aortic valve replacement (TAVR) in diabetic patients are limited by small sample size and contradictory results. We aimed to establish the magnitude of risk and the incremental influence of insulin dependency by examining short- and long-term adverse outcomes according to DM status and therapy in the world's largest TAVR registry. We analyzed data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. In-hospital mortality, 30-day mortality, and 1-year mortality after TAVR in patients with and without DM were evaluated using multivariate modeling. Among 47 643 patients treated with TAVR from November 2011 through September 2015 at 394 US hospitals, there were 17 849 (37.5%) patients with DM. Overall, 6600 of the diabetic patients were insulin treated (IT). Thirty-day mortality was 5.0% in patients with DM (6.1% in IT DM and 4.4% in non-IT DM; P <0.001) versus 5.9% in patients without DM ( P <0.001). Overall, 1-year mortality was 21.8% in patients with DM (24.8% in IT DM and 20.1% in non-IT DM; P <0.001) versus 21.2% in patients without DM ( P =0.274). In a multivariable model, DM was associated with increased 1-year mortality (hazard ratio, 1.30; 95% confidence interval, 1.13-1.49; P <0.001). Subgroup multivariable analysis showed stronger mortality association in IT diabetics (hazard ratio, 1.57; 95% confidence interval, 1.28-1.91; P <0.001) than in non-IT diabetics (hazard ratio, 1.17; 95% confidence interval, 1.00-1.38; P =0.052). Our data establish the magnitude of short- and long-term risk conferred by DM and the incremental risk conferred by insulin dependency in the performance of TAVR. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01737528. © 2017 American Heart Association, Inc.

Total ellipse of the heart valve: the impact of eccentric stent distortion on the regional dynamic deformation of pericardial tissue leaflets of a transcatheter aortic valve replacement

PubMed Central

Gunning, Paul S.; Saikrishnan, Neelakantan; Yoganathan, Ajit P.; McNamara, Laoise M.

2015-01-01

Transcatheter aortic valve replacements (TAVRs) are a percutaneous alternative to surgical aortic valve replacements and are used to treat patients with aortic valve stenosis. This minimally invasive procedure relies on expansion of the TAVR stent to radially displace calcified aortic valve leaflets against the aortic root wall. However, these calcium deposits can impede the expansion of the device causing distortion of the valve stent and pericardial tissue leaflets. The objective of this study was to elucidate the impact of eccentric TAVR stent distortion on the dynamic deformation of the tissue leaflets of the prosthesis in vitro. Dual-camera stereophotogrammetry was used to measure the regional variation in strain in a leaflet of a TAVR deployed in nominal circular and eccentric (eccentricity index = 28%) orifices, representative of deployed TAVRs in vivo. It was observed that (i) eccentric stent distortion caused incorrect coaptation of the leaflets at peak diastole resulting in a ‘peel-back’ leaflet geometry that was not present in the circular valve and (ii) adverse bending of the leaflet, arising in the eccentric valve at peak diastole, caused significantly higher commissure strains compared with the circular valve in both normotensive and hypertensive pressure conditions (normotension: eccentric = 13.76 ± 2.04% versus circular = 11.77 ± 1.61%, p = 0.0014, hypertension: eccentric = 15.07 ± 1.13% versus circular = 13.56 ± 0.87%, p = 0.0042). This study reveals that eccentric distortion of a TAVR stent can have a considerable impact on dynamic leaflet deformation, inducing deleterious bending of the leaflet and increasing commissures strains, which might expedite leaflet structural failure compared to leaflets in a circular deployed valve. PMID:26674192

Echocardiographic parameters predicting acute hemodynamically significant mitral regurgitation during transfemoral transcatheter aortic valve replacement.

PubMed

Ito, Asahiro; Iwata, Shinichi; Mizutani, Kazuki; Nonin, Shinichi; Nishimura, Shinsuke; Takahashi, Yosuke; Yamada, Tokuhiro; Murakami, Takashi; Shibata, Toshihiko; Yoshiyama, Minoru

2018-03-01

Alteration in mitral valve morphology resulting from retrograde stiff wire entanglement sometimes causes hemodynamically significant acute mitral regurgitation (MR) during transfemoral transcatheter aortic valve replacement (TAVR). Little is known about the echocardiographic parameters related to hemodynamically significant acute MR. This study population consisted of 64 consecutive patients who underwent transfemoral TAVR. We defined hemodynamically significant acute MR as changes in the severity of MR with persistent hypotension (systolic blood pressure < 80-90 mm Hg or mean arterial pressure 30 mm Hg lower than baseline). Hemodynamically significant acute MR occurred in 5 cases (7.8%). Smaller left ventricular end-systolic diameter (LVDs), larger ratios of the coiled section of stiff wire tip to LVDs (wire-width/LVDs), and higher Wilkins score were significantly associated with hemodynamically significant acute MR (P < .05), whereas the parameters of functional MR (annular area, anterior-posterior diameter, tenting area, and coaptation length) were not. Moreover, when patients were divided into 4 groups according to wire-width/LVDs and Wilkins score, the group with the larger wire-width/LVDs and higher Wilkins score improved prediction rates (P < .05). Small left ventricle or wire oversizing and calcific mitral apparatus were predictive of hemodynamically significant acute MR. These findings are important for risk stratification, and careful monitoring using intraoperative transesophageal echocardiography may improve the safety in this population. © 2017, Wiley Periodicals, Inc.

The utility of live video capture to enhance debriefing following transcatheter aortic valve replacement.

PubMed

Seamans, David P; Louka, Boshra F; Fortuin, F David; Patel, Bhavesh M; Sweeney, John P; Lanza, Louis A; DeValeria, Patrick A; Ezrre, Kim M; Ramakrishna, Harish

2016-10-01

The surgical and procedural specialties are continually evolving their methods to include more complex and technically difficult cases. These cases can be longer and incorporate multiple teams in a different model of operating room synergy. Patients are frequently older, with comorbidities adding to the complexity of these cases. Recording of this environment has become more feasible recently with advancement in video and audio capture systems often used in the simulation realm. We began using live capture to record a new procedure shortly after starting these cases in our institution. This has provided continued assessment and evaluation of live procedures. The goal of this was to improve human factors and situational challenges by review and debriefing. B-Line Medical's LiveCapture video system was used to record successive transcatheter aortic valve replacement (TAVR) procedures in our cardiac catheterization/laboratory. An illustrative case is used to discuss analysis and debriefing of the case using this system. An illustrative case is presented that resulted in long-term changes to our approach of these cases. The video capture documented rare events during one of our TAVR procedures. Analysis and debriefing led to definitive changes in our practice. While there are hurdles to the use of this technology in every institution, the role for the ongoing use of video capture, analysis, and debriefing may play an important role in the future of patient safety and human factors analysis in the operating environment.

Cost-utility of transcatheter aortic valve implantation for inoperable patients with severe aortic stenosis treated by medical management: a UK cost-utility analysis based on patient-level data from the ADVANCE study

PubMed Central

Brecker, Stephen; Mealing, Stuart; Padhiar, Amie; Eaton, James; Sculpher, Mark; Busca, Rachele; Bosmans, Johan; Gerckens, Ulrich J; Wenaweser, Peter; Tamburino, Corrado; Bleiziffer, Sabine; Piazza, Nicolo; Moat, Neil; Linke, Axel

2014-01-01

Objective To use patient-level data from the ADVANCE study to evaluate the cost-effectiveness of transcatheter aortic valve implantation (TAVI) compared to medical management (MM) in patients with severe aortic stenosis from the perspective of the UK NHS. Methods A published decision-analytic model was adapted to include information on TAVI from the ADVANCE study. Patient-level data informed the choice as well as the form of mathematical functions that were used to model all-cause mortality, health-related quality of life and hospitalisations. TAVI-related resource use protocols were based on the ADVANCE study. MM was modelled on publicly available information from the PARTNER-B study. The outcome measures were incremental cost-effectiveness ratios (ICERs) estimated at a range of time horizons with benefits expressed as quality-adjusted life-years (QALY). Extensive sensitivity/subgroup analyses were undertaken to explore the impact of uncertainty in key clinical areas. Results Using a 5-year time horizon, the ICER for the comparison of all ADVANCE to all PARTNER-B patients was £13 943 per QALY gained. For the subset of ADVANCE patients classified as high risk (Logistic EuroSCORE >20%) the ICER was £17 718 per QALY gained). The ICER was below £30 000 per QALY gained in all sensitivity analyses relating to choice of MM data source and alternative modelling approaches for key parameters. When the time horizon was extended to 10 years, all ICERs generated in all analyses were below £20 000 per QALY gained. Conclusion TAVI is highly likely to be a cost-effective treatment for patients with severe aortic stenosis. PMID:25349700

Cost-utility of transcatheter aortic valve implantation for inoperable patients with severe aortic stenosis treated by medical management: a UK cost-utility analysis based on patient-level data from the ADVANCE study.

PubMed

Brecker, Stephen; Mealing, Stuart; Padhiar, Amie; Eaton, James; Sculpher, Mark; Busca, Rachele; Bosmans, Johan; Gerckens, Ulrich J; Wenaweser, Peter; Tamburino, Corrado; Bleiziffer, Sabine; Piazza, Nicolo; Moat, Neil; Linke, Axel

2014-01-01

To use patient-level data from the ADVANCE study to evaluate the cost-effectiveness of transcatheter aortic valve implantation (TAVI) compared to medical management (MM) in patients with severe aortic stenosis from the perspective of the UK NHS. A published decision-analytic model was adapted to include information on TAVI from the ADVANCE study. Patient-level data informed the choice as well as the form of mathematical functions that were used to model all-cause mortality, health-related quality of life and hospitalisations. TAVI-related resource use protocols were based on the ADVANCE study. MM was modelled on publicly available information from the PARTNER-B study. The outcome measures were incremental cost-effectiveness ratios (ICERs) estimated at a range of time horizons with benefits expressed as quality-adjusted life-years (QALY). Extensive sensitivity/subgroup analyses were undertaken to explore the impact of uncertainty in key clinical areas. Using a 5-year time horizon, the ICER for the comparison of all ADVANCE to all PARTNER-B patients was £13 943 per QALY gained. For the subset of ADVANCE patients classified as high risk (Logistic EuroSCORE >20%) the ICER was £17 718 per QALY gained). The ICER was below £30 000 per QALY gained in all sensitivity analyses relating to choice of MM data source and alternative modelling approaches for key parameters. When the time horizon was extended to 10 years, all ICERs generated in all analyses were below £20 000 per QALY gained. TAVI is highly likely to be a cost-effective treatment for patients with severe aortic stenosis.

Transcatheter umbrella closure of valvular and paravalvular leaks.

PubMed

Hourihan, M; Perry, S B; Mandell, V S; Keane, J F; Rome, J J; Bittl, J A; Lock, J E

1992-11-15

Our aim was to adapt the technique of transcatheter umbrella closure of intracardiac defects for closure of valvular and paravalvular defects. The double-umbrella device developed by Rashkind and Cuaso has been safely and effectively delivered across a host of intracardiac defects, but transcatheter closure of valvular and paravalvular leaks has not been reported. Between February 1987 and September 1990, eight patients who were believed to be poor operative candidates were taken to the catheterization laboratory for transcatheter double-umbrella closure of a valvular or a paravalvular leak. Four patients had a paravalvular leak around a prosthetic aortic valve. The other four patients had a valvular leak: one patient with a regurgitant native aortic valve after a Stansel procedure and three patients with a regurgitant porcine valve in a left ventricular apex to descending aorta conduit. Placement of a double-umbrella device was attempted in seven of the eight patients and was successful in all seven. Device placement was not attempted in one patient because of the crescentic shape of his defect. Two patients required two devices for each closure; the other five required only one device each. Angiography, performed on six patients after device closure, demonstrated that three patients had a completely occluded defect, two had trivial residual flow and one patient had mild residual flow through the device. All significant complications occurred in one patient who had hemolysis and oliguria that resolved when the initial umbrella was replaced by a larger device. In addition, two devices migrated to the patient's pulmonary arteries but were retrieved in the catheterization laboratory without difficulty. No other early or late complications occurred in 21 to 50 months of follow-up. Of the four patients with a paravalvular leak, the one who did not receive a device died at operation, one patient died at operation for an associated defect (in the operating room the

Incidental findings in multislice computed tomography prior to transcatheter aortic valve implantation: frequency, clinical relevance and outcome.

PubMed

Trenkwalder, Teresa; Lahmann, Anna Lena; Nowicka, Magdalena; Pellegrini, Costanza; Rheude, Tobias; Mayr, N Patrick; Voss, Stephanie; Bleiziffer, Sabine; Lange, Rüdiger; Joner, Michael; Kasel, Albert M; Kastrati, Adnan; Schunkert, Heribert; Husser, Oliver; Hadamitzky, Martin; Hengstenberg, Christian

2018-02-21

Multislice computed tomography (MSCT) has emerged as the mainstay in patients planned for transcatheter aortic valve implantation (TAVI). Incidental findings (IF) in MSCT are common. However, the exact incidence, clinical relevance and further consequences of IF are unclear and it is controversial whether IF adversely affect patients' outcome. We analyzed MSCT data of 1050 patients screened for TAVI between January 2011 and December 2014. Median follow-up of patients was 20 months. In total, 3194 IF were identified, which were classified into clinically non-relevant IF (2872, 90%) and clinically relevant IF (322, 10%). In 25% of patients (258/1050) at least one clinically relevant IF was present. Age (80 ± 7 vs. 80 ± 7 years; p = 0.198) and EuroSCORE II (3.6% [2.1-5.7] vs. 3.6% [2.1-5.9]; p = 0.874) was similar between patients with and without a clinically relevant IF. TAVI was performed less frequently in patients with a clinically relevant IF (76% vs. 85%; p < 0.001), with more patients receiving surgical aortic valve replacement in that group (14% vs. 11%; p = 0.042), possibly due to the high rate of incidental aneurysms of the ascending aorta (n = 48). If TAVI was performed mortality did not differ (30-days: 4% vs. 3%; p = 0.339, 1-year: 11% vs. 14%; p = 0.226) between patients with and without a clinically relevant IF. Our study is the largest study to analyze prevalence, clinical relevance and therapeutic consequences of IF during screening for TAVI. IF in pre-procedural MSCT are common and clinically relevant in one-quarter of patients. However, these findings had no impact on overall mortality.

Bivalirudin versus heparin in patients undergoing percutaneous transcatheter aortic valve interventions: A systematic review and meta-analysis.

PubMed

Villablanca, Pedro A; Al-Bawardy, Rasha; Mohananey, Divyanshu; Maraboto, Carola; Weinreich, Michael; Gupta, Tanush; Briceno, David F; Ramakrishna, Harish

2017-12-01

Bivalirudin may be an effective anticoagulation alternative to heparin as anticoagulant agent in percutaneous transcatheter aortic valve interventions (PAVI). We aimed to compare safety and efficacy of bivalirudin versus heparin as the procedural anticoagulant agent in patients undergoing PAVI. We conducted an electronic database search of all published data. The primary efficacy endpoints were all-cause mortality, cardiovascular mortality, myocardial infarction, and stroke. Safety endpoints include major and life-threatening bleed according to VARC and BARC bleeding, blood transfusion, vascular complications, and acute kidney injury. Odds ratios (OR) and 95% confidence intervals (CI) computed using the Mantel-Haenszel method. Three studies (n = 1690 patients) were included, one randomized trial and two observational studies. There was a significant difference favoring bivalirudin over heparin for myocardial infarction (OR 0.41, 95%CI 0.20-0.87). There was no significant difference in all-cause mortality at 30 days (OR 0.97, 95%CI 0.62-1.52), cardiovascular mortality (OR 1.03, 95%CI 0.52-2.05), stroke (OR 1.23, 95%CI 0.62-2.46), vascular complications (OR 0.96, 95%CI 0.70-1.32), acute kidney injury (OR 1.03, 95%CI 0.53-2.00), blood transfusion (OR 0.67, 95% CI 0.45-1.01), major and life-threatening bleed (OR 0.74, 95%CI 0.37-1.49), and BARC bleeding (OR 0.52, 95%CI 0.23-1.18). In patient undergoing aortic valve interventions, no difference was seen between the use of bivalirudin and heparin as the procedural anticoagulant agent, except for a significant lower myocardial infarction events when bivalirudin was used. Further large randomized trials are needed to confirm current results. © 2017, Wiley Periodicals, Inc.

Percutaneous Transcatheter Interventions for Aortic Insufficiency in Continuous-Flow Left Ventricular Assist Device Patients: A Systematic Review and Meta-Analysis.

PubMed

Phan, Kevin; Haswell, Joshua M; Xu, Joshua; Assem, Yusuf; Mick, Stephanie L; Kapadia, Samir R; Cheung, Anson; Ling, Frederick S; Yan, Tristan D; Tchantchaleishvili, Vakhtang

De novo progressive aortic insufficiency (AI) is a side effect frequently related to prolonged support with continuous-flow left ventricular assist devices (CF-LVAD). Its progression can result in recurrent clinical heart failure symptoms and significantly increased mortality. Recently, percutaneous intervention methods, such as transcatheter aortic valve replacement (TAVR) and percutaneous occluder devices, have emerged. However, given the very scarce global experience with these approaches, evidence in the literature is lacking. We sought to assess the outcomes of CF-LVAD patients who had undergone percutaneous intervention for AI. A systematic search of six databases from inception to April 2016 was performed by two independent reviewers. Eligible studies were those that included series or cases where patients had percutaneous transcatheter interventions for AI in CF-LVAD patients. Data were extracted and meta-analyzed from the identified studies. A total of 29 patients from 15 published studies and 3 unpublished records were included in the analysis. Mean patient age was 56.6 ± 13.7 years, and 72.4% were male. The etiology of heart failure resulting in LVAD placement was ischemic cardiomyopathy in 17.2%. The two intervention groups were TAVR (27.6%) and occluder devices (72.4%). A transfemoral approach (69%), apical approach (10%), brachial approach (7%), subclavian approach (3%), and mini-sternotomy (3%) were used. The preintervention AI grade was severe with a median grade of 4 (interquartile range, 4-4). Postoperatively, the AI grade improved significantly to a median grade of 0 (0-2). At long-term follow-up AI grade was still trivial with a median AI grade of 1 (0-1). Subgrouping the treatments into the occluder device and TAVR, it was found that both interventional techniques were similarly effective in reducing the AI grade from severe to trivial. In terms of complications, from the occluder group, two patients were complicated with device migration

Cost-effectiveness considerations in transcatheter management of valvular heart disease.

PubMed

Gadey, Gautam; Reynolds, Matthew R

2014-09-01

In 2011, health care spending in Canada accounted for 11.2% of gross domestic product. Increased life expectancy, combined with the fact that new medical technologies generally tend to improve clinical results at an increased cost, are leading developed nations to devote rising amounts of financial resources to health care. Valvular heart disease is an example of an age-related health problem with rising prevalence that has recently seen an emergence of new catheter-based technologies, which are rapidly changing the treatment landscape. This article reviews the current literature on the health economics of catheter-based valve therapies. Transcatheter aortic valve replacement (TAVR), a less invasive approach to valve replacement, is currently approved in the United States, Canada, and Europe for 2 groups of patients: those with symptomatic severe aortic stenosis who are unsuitable for surgery and those who are suitable but are at high risk for surgery. TAVR, when compared with medical therapy, results in significant improvement in survival for inoperable patients, with incremental costs that are generally considered to be acceptable in most western nations. However, in high-risk surgical candidates, TAVR has shown similar survival rates when compared with surgical aortic valve replacement, with only short-term advantages in quality of life. Cost-effectiveness ratios in this population have varied widely based on differing estimates of incremental costs. Information regarding the health economics of transcatheter mitral valve therapies is still quite preliminary and limited to the MitraClip (Abbott Laboratories, Abbott Park, IL). Ongoing trials should provide additional information about the health economics of this new technology. Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Acute Kidney Injury With the RenalGuard System in Patients Undergoing Transcatheter Aortic Valve Replacement: The PROTECT-TAVI Trial (PROphylactic effecT of furosEmide-induCed diuresis with matched isotonic intravenous hydraTion in Transcatheter Aortic Valve Implantation).

PubMed

Barbanti, Marco; Gulino, Simona; Capranzano, Piera; Immè, Sebastiano; Sgroi, Carmelo; Tamburino, Claudia; Ohno, Yohei; Attizzani, Guilherme F; Patanè, Martina; Sicuso, Rita; Pilato, Gerlando; Di Landro, Alessio; Todaro, Denise; Di Simone, Emanuela; Picci, Andrea; Giannetto, Giuliana; Costa, Giuliano; Deste, Wanda; Giannazzo, Daniela; Grasso, Carmelo; Capodanno, Davide; Tamburino, Corrado

2015-10-01

The purpose of this study was to investigate the effect of the RenalGuard System (PLC Medical Systems, Milford, Massachusetts) on prevention of acute kidney injury (AKI) in patients undergoing transcatheter aortic valve replacement (TAVR). TAVR is associated with varying degrees of post-procedural AKI. The RenalGuard System is a dedicated device designed for contrast-induced AKI prevention. Whether this device is also effective in patients with severe aortic stenosis undergoing TAVR is unexplored. The present is an investigator-driven, single-center, prospective, open-label, registry-based randomized study that used the TAVR institutional registry of the Ferrarotto Hospital in Catania, Italy, as the platform for randomization, data collection, and follow-up assessment. A total of 112 consecutive patients undergoing TAVR were randomly assigned to hydration with normal saline solution controlled by the RenalGuard system and furosemide (RenalGuard group) or normal saline solution (control group). The primary endpoint was the incidence of Valve Academic Research Consortium-defined AKI in the first 72 h after the procedure. The AKI rate was lower in the RenalGuard group than in the control group (n = 3 [5.4%] vs. n =14 [25.0%], respectively, p = 0.014). The majority of patients (5.4% vs. 23.2%) developed a mild AKI (stage 1); severe damage (stage 3) occurred only in 1 patient in the control group (0.0% vs. 1.8%). No case of in-hospital renal failure requiring dialysis was reported. No significant differences in terms of mortality, cerebrovascular events, bleeding, and hospitalization for heart failure were noted in both groups at 30 days. Furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVR. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Quantitative Prediction of Paravalvular Leak in Transcatheter Aortic Valve Replacement Based on Tissue-Mimicking 3D Printing.

PubMed

Qian, Zhen; Wang, Kan; Liu, Shizhen; Zhou, Xiao; Rajagopal, Vivek; Meduri, Christopher; Kauten, James R; Chang, Yung-Hang; Wu, Changsheng; Zhang, Chuck; Wang, Ben; Vannan, Mani A

2017-07-01

This study aimed to develop a procedure simulation platform for in vitro transcatheter aortic valve replacement (TAVR) using patient-specific 3-dimensional (3D) printed tissue-mimicking phantoms. We investigated the feasibility of using these 3D printed phantoms to quantitatively predict the occurrence, severity, and location of any degree of post-TAVR paravalvular leaks (PVL). We have previously shown that metamaterial 3D printing technique can be used to create patient-specific phantoms that mimic the mechanical properties of biological tissue. This may have applications in procedural planning for cardiovascular interventions. This retrospective study looked at 18 patients who underwent TAVR. Patient-specific aortic root phantoms were created using the tissue-mimicking 3D printing technique using pre-TAVR computed tomography. The CoreValve (self-expanding valve) prostheses were deployed in the phantoms to simulate the TAVR procedure, from which post-TAVR aortic root strain was quantified in vitro. A novel index, the annular bulge index, was measured to assess the post-TAVR annular strain unevenness in the phantoms. We tested the comparative predictive value of the bulge index and other known predictors of post-TAVR PVL. The maximum annular bulge index was significantly different among patient subgroups that had no PVL, trace-to-mild PVL, and moderate-to-severe PVL (p = 0.001). Compared with other known PVL predictors, bulge index was the only significant predictor of moderate-severe PVL (area under the curve = 95%; p < 0.0001). Also, in 12 patients with post-TAVR PVL, the annular bulge index predicted the major PVL location in 9 patients (accuracy = 75%). In this proof-of-concept study, we have demonstrated the feasibility of using 3D printed tissue-mimicking phantoms to quantitatively assess the post-TAVR aortic root strain in vitro. A novel indicator of the post-TAVR annular strain unevenness, the annular bulge index, outperformed the other

Meta-Analysis of Perioperative Stroke and Mortality in Transcatheter Aortic Valve Implantation.

PubMed

Muralidharan, Aditya; Thiagarajan, Karthy; Van Ham, Raymond; Gleason, Thomas G; Mulukutla, Suresh; Schindler, John T; Jeevanantham, Vinodh; Thirumala, Parthasarathy D

2016-10-01

Transcatheter aortic valve implantation (TAVI) is a rapidly evolving safe method with decreasing incidence of perioperative stroke. There is a void in literature concerning the impact of stroke after TAVI in predicting 30-day stroke-related mortality. The primary aim of this meta-analysis was to determine whether perioperative stroke increases risk of stroke-related mortality after TAVI. Online databases, using relevant keywords, and additional related records were searched to retrieve articles involving TAVI and stroke after TAVI. Data were extracted from the finalized studies and analyzed to generate a summary odds ratio (OR) of stroke-related mortality after TAVI. The stroke rate and stroke-related mortality rate in the total patient population were 3.07% (893 of 29,043) and 12.27% (252 of 2,053), respectively. The all-cause mortality rate was 7.07% (2,053 of 29,043). Summary OR of stroke-related mortality after TAVI was estimated to be 6.45 (95% confidence interval 3.90 to 10.66, p <0.0001). Subgroup analyses were performed among age, approach, and valve type. Only 1 subgroup, transapical TAVI, was not significantly associated with stroke-related mortality (OR 1.97, 95% confidence interval, 0.43 to 7.43, p = 0.42). A metaregression was conducted among females, New York Heart Association class III/IV status, previous stroke, valve type, and implantation route. All failed to exhibit any significant associations with the OR. In conclusion, perioperative strokes after TAVI are associated with >6 times greater risk of 30-day stroke-related mortality. Transapical TAVI is not associated with increased stroke-related mortality in patients who suffer from perioperative stroke. Preventative measures need to be taken to alleviate the elevated rates of stroke after TAVI and subsequent direct mortality. Copyright © 2016 Elsevier Inc. All rights reserved.

Surgical Approaches to Aortic Valve Replacement and Repair—Insights and Challenges

PubMed Central

Ramchandani, Mahesh; Reardon, Michael J

2014-01-01

Since 1960, surgical aortic valve replacement (sAVR) had been the only effective treatment for symptomatic severe aortic stenosis until the recent development of transcatheter aortic valve replacement (TAVR). TAVR has offered an alternative, minimally invasive treatment approach particularly for patients whose age or co-morbidities make them unsuitable for sAVR. The rapid and enthusiastic utilization of this new technique has triggered some speculation about the imminent demise of sAVR. We believe that despite the recent advances in TAVR, surgical approach to aortic valve replacement has continued to develop and will continue to be highly relevant in the future. This article will discuss the recent developments and current approaches for sAVR, and how these approaches will keep pace with catheter-based technologies. PMID:29588775

Is local anesthesia the optimum strategy in retrograde transcatheter aortic valve implantation? A systematic review and meta-analysis.

PubMed

O' Sullivan, Katie E; Bracken-Clarke, Darragh; Segurado, Ricardo; Barry, Mitchel; Sugrue, Declan; Flood, Georgina; Hurley, John

2014-09-01

Retrograde transcatheter aortic valve implantation (TAVI) can be performed under local anesthesia (LA) or general anesthesia (GA); however, a wide variation in practice exists. PubMed was searched between 2009 and 2013. Data were extracted from eligible studies. Random-effects meta-analysis was performed using DerSimonian Laird between-study variance. There was no statistically significant difference identified between groups based on age or EuroSCORE. There was no statistically significant difference seen in all-cause mortality, or complication rates between groups. Mean procedural duration was 36 minutes shorter in the LA group (p = 0.001). There was increased vasopressor use in the GA group (odds ratio 3.92; p = 0.017). Mean hospital stay was 3.41 days shorter in the LA group (p = 0.018). Results suggest that the use of LA for retrograde TAVI is feasible. There are several potential benefits associated, shorter procedural duration, and hospital stay with lower vasopressor requirements. Further studies and randomized trials are mandatory to confirm the presented findings and to identify those patients for whom LA would be appropriate. Georg Thieme Verlag KG Stuttgart · New York.

Evolving trends in aortic valve replacement: A statewide experience.

PubMed

Kim, Karen M; Shannon, Francis; Paone, Gaetano; Lall, Shelly; Batra, Sanjay; Boeve, Theodore; DeLucia, Alphonse; Patel, Himanshu J; Theurer, Patricia F; He, Chang; Clark, Melissa J; Sultan, Ibrahim; Deeb, George Michael; Prager, Richard L

2018-06-17

Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) for the treatment of aortic stenosis in patients at intermediate, high, and extreme risk for mortality from SAVR. We examined recent trends in aortic valve replacement (AVR) in Michigan. The Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative (MSTCVS-QC) database was used to determine the number of SAVR and TAVR cases performed from January 2012 through June 2017. Patients were divided into low, intermediate, high, and extreme risk groups based on STS predicted risk of mortality (PROM). TAVR patients in the MSTCVS-QC database were also matched with those in the Transcatheter Valve Therapy Registry to determine their Heart Team-designated risk category. During the study period 9517 SAVR and 4470 TAVR cases were performed. Total annual AVR volume increased by 40.0% (from 2086 to 2920), with a 13.3% decrease in number of SAVR cases (from 1892 to 1640) and a 560% increase in number of TAVR cases (from 194 to 1280). Greater than 90% of SAVR patients had PROM ≤8%. While >70% of TAVR patients had PROM ≤ 8%, they were mostly designated as high or extreme risk by a Heart Team. During the study period, SAVR volume gradually declined and TAVR volume dramatically increased. This was mostly due to a new group of patients with lower STS PROM who were designated as higher risk by a Heart Team due to characteristics not completely captured by the STS PROM score. © 2018 Wiley Periodicals, Inc.

Fluid-structure interaction study of transcatheter aortic valve dynamics using smoothed particle hydrodynamics

PubMed Central

Mao, Wenbin; Li, Kewei; Sun, Wei

2016-01-01

Computational modeling of heart valve dynamics incorporating both fluid dynamics and valve structural responses has been challenging. In this study, we developed a novel fully-coupled fluid-structure interaction (FSI) model using smoothed particle hydrodynamics (SPH). A previously developed nonlinear finite element (FE) model of transcatheter aortic valves (TAV) was utilized to couple with SPH to simulate valve leaflet dynamics throughout the entire cardiac cycle. Comparative simulations were performed to investigate the impact of using FE-only models versus FSI models, as well as an isotropic versus an anisotropic leaflet material model in TAV simulations. From the results, substantial differences in leaflet kinematics between FE-only and FSI models were observed, and the FSI model could capture the realistic leaflet dynamic deformation due to its more accurate spatial and temporal loading conditions imposed on the leaflets. The stress and the strain distributions were similar between the FE and FSI simulations. However, the peak stresses were different due to the water hammer effect induced by the flow inertia in the FSI model during the closing phase, which led to 13%–28% lower peak stresses in the FE-only model compared to that of the FSI model. The simulation results also indicated that tissue anisotropy had a minor impact on hemodynamics of the valve. However, a lower tissue stiffness in the radial direction of the leaflets could reduce the leaflet peak stress caused by the water hammer effect. It is hoped that the developed FSI models can serve as an effective tool to better assess valve dynamics and optimize next generation TAV designs. PMID:27844463

Diabetes mellitus is associated with increased acute kidney injury and 1-year mortality after transcatheter aortic valve replacement: A meta-analysis.

PubMed

Mina, George S; Gill, Priyanka; Soliman, Demiana; Reddy, Pratap; Dominic, Paari

2017-09-01

Diabetes mellitus (DM) is associated with adverse outcomes after surgical aortic valve replacement. However, there are conflicting data on the impact of DM on outcomes of transcatheter aortic valve replacement (TAVR). DM is associated with poor outcomes after different cardiac procedures. Therefore, DM can also be associated with poor outcomes after TAVR. We searched PubMed and Cochrane Central Register of Controlled Trials for studies that evaluated outcomes after TAVR and stratified at least 1 of the studied endpoints by DM status. The primary endpoint was all-cause mortality at 1 year. Secondary endpoints were early (up to 30 days) mortality, acute kidney injury (AKI), cerebrovascular accident (CVA), major bleeding, and major vascular complications. Pooled odds ratio (OR) and 95% confidence interval (CI) were calculated using random effects models. We included 64 studies with a total of 38 686 patients. DM was associated with significantly higher 1-year mortality (OR: 1.14, 95% CI: 1.04-1.26, P = 0.008) and periprocedural AKI (OR: 1.28, 95% CI: 1.08-1.52, P = 0.004). On the other hand, there were no significant differences between diabetics and nondiabetics in early mortality, CVAs, major bleeding, or major vascular complications. DM is associated with increased 1-year mortality and periprocedural AKI in patients undergoing TAVR. The results of this study suggest that DM is a predictor of adverse outcomes in patients undergoing TAVR. © 2017 Wiley Periodicals, Inc.

Percutaneous Implantation of the self-expanding valve Prosthesis a patient with homozygous familial hypercholesterolemia severe aortic stenosis and porcelain aorta.

PubMed

Sahiner, Levent; Asil, Serkan; Kaya, Ergün Baris; Ozer, Necla; Aytemir, Kudret

2016-10-01

Transcatheter aortic valve implantation (TAVI) has shown favorable outcomes in patients with severe symptomatic aortic valve stenosis who are at high surgical risk or inappropriate for open heart surgery. However, concerns exist over treating patients who have porcelain aorta and familial hypercholesterolemia, due to the potential complications of aortic root and aortic annulus. In this case report, we present a patient with familial hypercholesterolemia, symptomatic severe aortic stenosis, previous coronary artery bypass grafting and porcelain aorta, who was successfully treated with TAVI using a CoreValve. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

RenalGuard System for the prevention of acute kidney injury in patients undergoing transcatheter aortic valve implantation.

PubMed

Visconti, Gabriella; Focaccio, Amelia; Donahue, Michael; Golia, Bruno; Marzano, Antonio; Donnarumma, Elvira; Ricciardelli, Bruno; Selvetella, Lucio; Marino, Luigi; Briguori, Carlo

2016-04-08

We aimed to assess whether the RenalGuard™ System is effective in preventing acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI). Forty-eight consecutive patients with chronic kidney disease (CKD) scheduled for TAVI were assigned to: 1) hydration with sodium bicarbonate solution (Control group), or 2) hydration with RenalGuard Therapy (RenalGuard group). Hypotension was defined as periprocedural mean blood pressure <55 mmHg. The primary endpoint was the occurrence of AKI (i.e., an increase of ≥0.3 mg/dL in the serum creatinine concentration at seven days). AKI occurred in 10/26 (38.5%) patients in the Control group and in 1/22 (4.5%) patients in the RenalGuard group (p=0.005, odds ratio [OR] 0.076, 95% confidence interval [CI]: 0.009-0.66). RenalGuard Therapy protected against AKI (OR 0.71, 95% CI: 0.07-0.775, p=0.026), whereas post-procedural hypotension (OR 3.88, 95% CI: 1.06-14.24, p=0.040), and contrast media volume (OR 3.65, 95% CI: 1.15-5.75, p=0.043) increased the risk of AKI. This non-randomised pilot study suggests that RenalGuard Therapy may be effective in preventing AKI in CKD patients undergoing TAVI.

Transcatheter Replacement of Stenotic Aortic Valve Normalizes Cardiac-Coronary Interaction by Restoration of Systolic Coronary Flow Dynamics as Assessed by Wave Intensity Analysis.

PubMed

Rolandi, M Cristina; Wiegerinck, Esther M A; Casadonte, Lorena; Yong, Ze-Yie; Koch, Karel T; Vis, Marije; Piek, Jan J; Baan, Jan; Spaan, Jos A E; Siebes, Maria

2016-04-01

Aortic valve stenosis (AS) can cause angina despite unobstructed coronary arteries, which may be related to increased compression of the intramural microcirculation, especially at the subendocardium. We assessed coronary wave intensity and phasic flow velocity patterns to unravel changes in cardiac-coronary interaction because of transcatheter aortic valve implantation (TAVI). Intracoronary pressure and flow velocity were measured at rest and maximal hyperemia in undiseased vessels in 15 patients with AS before and after TAVI and in 12 control patients. Coronary flow reserve, systolic and diastolic velocity time integrals, and the energies of forward (aorta-originating) and backward (microcirculatory-originating) coronary waves were determined. Coronary flow reserve was 2.8±0.2 (mean±SEM) in control and 1.8±0.1 in AS (P<0.005) and was not restored by TAVI. Compared with control, the resting backward expansion wave was 45% higher in AS. The peak of the systolic forward compression wave was delayed in AS, consistent with a delayed peak aortic pressure, which was partially restored after TAVI. The energy of forward waves doubled after TAVI, whereas the backward expansion wave increased by >30%. The increase in forward compression wave with TAVI was related to an increase in systolic velocity time integral. AS or TAVI did not alter diastolic velocity time integral. Reduced coronary forward wave energy and systolic velocity time integral imply a compromised systolic flow velocity with AS that is restored after TAVI, suggesting an acute relief of excess compression in systole that likely benefits subendocardial perfusion. Vasodilation is observed to be a major determinant of backward waves. © 2016 American Heart Association, Inc.

The Prognostic Effects of Coronary Disease Severity and Completeness of Revascularization on Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement.

PubMed

Witberg, Guy; Regev, Ehud; Chen, Shmuel; Assali, Abbid; Barbash, Israel M; Planer, David; Vaknin-Assa, Hana; Guetta, Victor; Vukasinovic, Vojislav; Orvin, Katia; Danenberg, Haim D; Segev, Amit; Kornowski, Ran

2017-07-24

The study sought to examine the effect of coronary artery disease (CAD) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR). CAD is common in the TAVR population. However, there are conflicting data on the prognostic significance of CAD and its treatment in this population. The authors analyzed 1,270 consecutive patients with severe aortic stenosis (AS) undergoing TAVR at 3 Israeli centers. They investigated the association of CAD severity (no CAD, nonsevere CAD [i.e., SYNTAX score (SS) <22], severe CAD [SS >22]) and revascularization completeness ("reasonable" incomplete revascularization [ICR] [i.e., residual SS <8]; ICR [residual SS >8]) with all-cause mortality following TAVR using a Cox proportional hazards ratio model adjusted for multiple prognostic variables. Of the 1,270 patients, 817 (64%) had no CAD, 331 (26%) had nonsevere CAD, and 122 (10%) had severe CAD. Over a median follow-up of 1.9 years, 311 (24.5%) patients died. Mortality was higher in the severe CAD and the ICR groups, but not in the nonsevere CAD or "reasonable" ICR groups, versus no CAD. After multivariate adjustment, both severe CAD (hazard ratio: 2.091; p = 0.017) and ICR (hazard ratio: 1.720; p = 0.031) were associated with increased mortality. Only severe CAD was associated with increased mortality post-TAVR. More complete revascularization pre-TAVR may attenuate the association of severe CAD and mortality. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Outcomes for the Commercial Use of Self-Expanding Prostheses in Transcatheter Aortic Valve Replacement: A Report From the STS/ACC TVT Registry.

PubMed

Sorajja, Paul; Kodali, Susheel; Reardon, Michael J; Szeto, Wilson Y; Chetcuti, Stanley J; Hermiller, James; Chenoweth, Sharla; Adams, David H; Popma, Jeffrey J

2017-10-23

The authors sought to compare the outcomes of commercial transcatheter aortic valve replacement (TAVR) with the repositionable Evolut R platform to those observed with the CoreValve device in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry. TAVR continues to evolve, with rapid adoption of iterative changes for commercial practice. Insight into the outcomes of this adoption is needed. Patients in the TVT Registry who had TAVR using a 23-, 26-, or 29-mm self-expanding prosthesis were enrolled. Site-reported events for procedural, in-hospital, and 30-day outcomes were examined. Between January 2014 and April 2016, 9,616 patients underwent TAVR with a self-expanding prosthesis with data entered in the TVT Registry. Compared with patients treated with CoreValve TAVR, those who received Evolut R TAVR had a lower STS-PROM score (8.0 ± 5.4% vs. 8.7 ± 5.3%; p < 0.001), more iliofemoral access (91.6% vs. 89.2%; p < 0.001), and more frequently had conscious sedation (27.4% vs. 12.7%; p < 0.001). With Evolut R TAVR, there was less need for a second prosthesis (2.2% vs. 4.5%; p < 0.001), less device migration (0.2% vs. 0.6%; p = 0.01), a lower incidence of moderate/severe paravalvular regurgitation (post-procedure, 4.4% vs. 6.2%; p < 0.001), and shorter median hospital stay (4.0 vs. 5.0 days; p < 0.001). Patients treated with Evolut R TAVR had greater device success (96.3% vs. 94.9%; p = 0.001). At 30 days, Evolut R patients had both lower mortality (3.7% vs. 5.3%; p < 0.001) and less need for a pacemaker (18.3% vs. 20.1%; p = 0.03). Commercial adoption of the Evolut R platform is associated with significant improvements in acute outcomes for patients undergoing TAVR for aortic stenosis. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Percutaneous focused force aortic valvuloplasty using the buddy-catheter technique.

PubMed

Tada, Norio; Ootomo, Tatsushi; Meguro, Taiichiro

2012-06-01

Percutaneous transcatheter aortic valvuloplasty is seriously limited by high restenosis rates. We report a case where the use of a buddy-catheter technique during balloon inflation allowed increased focused force onto calcified stiff commissures with an increase in resultant valve area. This technique may result in further valve area enlargement and decrease the restenosis rate.

The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic Valve Replacement in Real-World Patients.

PubMed

Bosmans, Johan; Bleiziffer, Sabine; Gerckens, Ulrich; Wenaweser, Peter; Brecker, Stephen; Tamburino, Corrado; Linke, Axel

2015-07-21

Transcatheter aortic valve replacement (TAVR) enables treatment of high-risk patients with symptomatic aortic stenosis without open-heart surgery; however, the benefits are mitigated by the potential for neurological events. This study sought to determine the timing and causes of clinically relevant neurological events after self-expandable TAVR. We enrolled 1,015 patients, of whom 996 underwent TAVR with a self-expandable system at 44 TAVR-experienced centers in Europe, Colombia, and Israel. Neurological events were evaluated for 3 distinct time periods: periprocedural (0 to 1 days post TAVR); early (2 to 30 days); and late (31 to 730 days). In this real-world study, neurological events were first referred to the site neurologist and then reviewed by an independent neurologist. The overall stroke rate was 1.4% through the first day post-procedure, 3.0% at 30 days, and 5.6% at 2 years. There were no significant predictors of periprocedural stroke or stroke/transient ischemic attack (TIA) combined. Significant predictors of early stroke were acute kidney injury (p = 0.03), major vascular complication (p = 0.04), and female sex (p = 0.04). For stroke/TIA combined, prior atrial fibrillation (p = 0.03) and major vascular complication (p = 0.009) were predictive. Coronary artery bypass graft surgery was the only significant predictor of late stroke (p = 0.007) or late stroke/TIA (p = 0.06). Treatment of high-risk patients with aortic stenosis using a self-expandable system was associated with a low stroke rate at short- and long-term follow-up. Multivariable predictors of clinically relevant neurological events differed on the basis of the timing after TAVR. (CoreValve Advance International Post Market Study; NCT01074658). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Changes in self-reported health and quality of life in octogenarian patients one month after transcatheter aortic valve implantation.

PubMed

Olsen, Siv Js; Fridlund, Bengt; Eide, Leslie Sp; Hufthammer, Karl O; Kuiper, Karel Kj; Nordrehaug, Jan E; Skaar, Elisabeth; Norekvål, Tone M

2017-01-01

In addition to favourable results regarding mortality and morbidity it is important to identify the impact transcatheter aortic valve implantation (TAVI) has on patients' quality of life. The aims were: (i) to describe clinical characteristics, self-reported health and quality of life in octogenarians before TAVI intervention; (ii) to determine changes in self-reported health and quality of life one month after TAVI; and (iii) to establish the clinical importance of the findings. A prospective cohort study was conducted on consecutively enrolled octogenarians with severe aortic stenosis undergoing TAVI ( N = 65). Self-reported health and quality of life were recorded at baseline and one month later using two global questions from the World Health Organization Quality of Life Instrument Abbreviated (WHOQOL-BREF), the generic Short Form Health 12 and the disease-specific Minnesota Living with Heart Failure Questionnaire. One month after TAVI, WHOQOL-BREF showed that self-reported health improved moderately ( p < 0.001), while quality of life improved slightly, but not statistically significantly ( p = 0.06). There were changes in all Short Form Health 12 domains, except social functioning and role emotional. The estimated changes were 3.6 to 5.8 with large confidence intervals. The Physical Component Summary increased statistically significantly from baseline to 30 days (30.6-34.7; p = 0.02), but the Mental Component Summary did not (46.9-50.0; p = 0.13). Despite being an advanced treatment performed in a high risk population, TAVI in octogenarians improves short-term self-reported global health and generic physical health and quality of life. These patient-reported outcomes have importance, particularly in this age group.

Background differences in baseline and stimulated MMP levels influence abdominal aortic aneurysm susceptibility

PubMed Central

Dale, Matthew A.; Ruhlman, Melissa K.; Zhao, Shijia; Meisinger, Trevor; Gu, Linxia; Swier, Vicki J.; Agrawal, Devendra K.; Greiner, Timothy C.; Carson, Jeffrey S.; Baxter, B. Timothy; Xiong, Wanfen

2015-01-01

Objective Evidence has demonstrated profound influence of genetic background on cardiovascular phenotypes. Murine models in Marfan syndrome (MFS) have shown that genetic background-related variations affect thoracic aortic aneurysm formation, rupture, and lifespan of mice. MFS mice with C57Bl/6 genetic background are less susceptible to aneurysm formation compared to the 129/SvEv genetic background. In this study, we hypothesize that susceptibility to abdominal aortic aneurysm (AAA) will be increased in 129/SvEv mice versus C57Bl/6 mice. We tested this hypothesis by assessing differences in aneurysm size, tissue properties, immune response, and MMP expression. Methods Mice of C57Bl/6 or 129/SvEv background underwent AAA induction by periaortic application of CaCl2. Baseline aortic diameters, tissue properties and MMP levels were measured. After aneurysm induction, diameters, MMP expression, and immune response (macrophage infiltration and bone marrow transplantation) were measured. Results Aneurysms were larger in 129/SvEv mice than C57Bl/6 mice (83.0% ± 13.6 increase compared to 57.8% ± 6.4). The aorta was stiffer in the 129/SvEv mice compared to C57Bl/6 mice (952.5 kPa ± 93.6 versus 621.4 kPa ± 84.2). Baseline MMP-2 and post-aneurysm MMP-2 and -9 levels were higher in 129/SvEv aortas compared to C57Bl/6 aortas. Elastic lamella disruption/fragmentation and macrophage infiltration were increased in 129/SvEv mice. Myelogenous cell reversal by bone marrow transplantation did not affect aneurysm size. Conclusions These data demonstrate that 129/SvEv mice are more susceptible to AAA compared to C57Bl/6 mice. Intrinsic properties of the aorta between the two strains of mice, including baseline expression of MMP-2, influence susceptibility to AAA. PMID:26546710

Mitral regurgitation in patients with severe aortic stenosis: diagnosis and management.

PubMed

Sannino, Anna; Grayburn, Paul A

2018-01-01

Severe aortic stenosis (AS) and mitral regurgitation (MR) frequently coexist. Although some observational studies have reported that moderate or severe MR is associated with higher mortality, the optimal management of such patients is still unclear. Simultaneous replacement of both aortic and mitral valves is linked to significantly higher morbidity and mortality. Recent advances in minimally invasive surgical or transcatheter therapies for MR allow for staged procedures in which surgical or transcatheter aortic valve replacement (SAVR/TAVR) is done first and MR severity re-evaluated afterwards. Current evidence suggests MR severity improves in some patients after SAVR or TAVR, depending on several factors (MR aetiology, type of valve used for TAVR, presence/absence of atrial fibrillation, residual aortic regurgitation, etc). However, as of today, the absence of randomised clinical trials does not allow for evidence-based recommendations about whether or not MR should be addressed at the time of SAVR or TAVR. A careful patient evaluation and clinical judgement are recommended to distinguish patients who might benefit from a double valve intervention from those in which MR should be left alone. The aim of this review is to report and critique the available data on this subject in order to help guide the clinical decision making in this challenging subset of patients. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The Value of the SYNTAX Score II in Predicting Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Ryan, Nicola; Nombela-Franco, Luis; Jiménez-Quevedo, Pilar; Biagioni, Corina; Salinas, Pablo; Aldazábal, Andrés; Cerrato, Enrico; Gonzalo, Nieves; Del Trigo, María; Núñez-Gil, Iván; Fernández-Ortiz, Antonio; Macaya, Carlos; Escaned, Javier

2017-11-27

The predictive value of the SYNTAX score (SS) for clinical outcomes after transcatheter aortic valve implantation (TAVI) is very limited and could potentially be improved by the combination of anatomic and clinical variables, the SS-II. We aimed to evaluate the value of the SS-II in predicting outcomes in patients undergoing TAVI. A total of 402 patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI were included. Preprocedural TAVI angiograms were reviewed and the SS-I and SS-II were calculated using the SS algorithms. Patients were stratified in 3 groups according to SS-II tertiles. The coprimary endpoints were all-cause death and major adverse cardiovascular events (MACE), a composite of all-cause death, cerebrovascular event, or myocardial infarction at 1 year. Increased SS-II was associated with higher 30-day mortality (P=.036) and major bleeding (P=.015). The 1-year risk of death and MACE was higher among patients in the 3rd SS-II tertile (HR, 2.60; P=.002 and HR, 2.66; P<.001) and was similar among patients in the 2nd tertile (HR, 1.27; P=.507 and HR, 1.05; P=.895) compared with patients in the 1st tertile. The highest SS-II tertile was an independent predictor of long-term mortality (P=.046) and MACE (P=.001). The SS-II seems more suited to predict clinical outcomes in patients undergoing TAVI than the SS-I. Increased SS-II was associated with poorer clinical outcomes at 1 and 4 years post-TAVI, independently of the presence of coronary artery disease. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

The association between renal recovery after acute kidney injury and long-term mortality after transcatheter aortic valve replacement.

PubMed

Thongprayoon, Charat; Cheungpasitporn, Wisit; Srivali, Narat; Kittanamongkolchai, Wonngarm; Sakhuja, Ankit; Greason, Kevin L; Kashani, Kianoush B

2017-01-01

This study aimed to examine the association between renal recovery status at hospital discharge after acute kidney injury (AKI) and long-term mortality following transcatheter aortic valve replacement (TAVR). We screened all adult patients who survived to hospital discharge after TAVR for aortic stenosis at a quaternary referral medical center from January 1, 2008, through June 30, 2014. An AKI was defined as an increase in serum creatinine level of 0.3 mg/dL or a relative increase of 50% from baseline. Renal outcome at the time of discharge was evaluated by comparing the discharge serum creatinine level to the baseline level. Complete renal recovery was defined as no AKI at discharge, whereas partial renal recovery was defined as AKI without a need for renal replacement therapy at discharge. No renal recovery was defined as a need for renal replacement therapy at discharge. The study included 374 patients. Ninty-eight (26%) patients developed AKI during hospitalization: 55 (56%) had complete recovery; 39 (40%), partial recovery; and 4 (4%), no recovery. AKI development was significantly associated with increased risk of 2-year mortality (hazard ratio [HR], 2.20 [95% CI, 1.37-3.49]). For patients with AKI, the 2-year mortality rate for complete recovery was 34%; for partial recovery, 43%; and for no recovery, 75%; compared with 20% for patients without AKI (P < .001). In adjusted analysis, complete recovery (HR, 1.87 [95% CI, 1.03-3.23]); partial recovery (HR, 2.65 [95% CI, 1.40-4.71]) and no recovery (HR, 10.95 [95% CI, 2.59-31.49]) after AKI vs no AKI were significantly associated with increased risk of 2-year mortality. The mortality rate increased for all patients with AKI undergoing TAVR. A reverse correlation existed for progressively higher risk of death and the extent of AKI recovery.

Surgeon Involvement in Transcatheter Aortic Valve Replacement in the United States: A 2016 Society of Thoracic Surgeons Survey.

PubMed

Bavaria, Joseph E; Prager, Richard L; Naunheim, Keith S; Allen, Mark S; Higgins, Robert S D; Thourani, Vinod H; MacGillivray, Thomas E; Boden, Natalie; Sabik, Joseph F

2017-09-01

The Society of Thoracic Surgeons (STS) surveyed cardiothoracic surgeon participants in its Adult Cardiac Surgery Database (ACSD) to learn the extent of surgeon involvement in transcatheter aortic valve replacement (TAVR) procedures. An electronic survey was delivered to 2,594 surgeons in June 2016. When the survey closed 2 weeks later, 487 completed surveys had been submitted for a response rate of 18.8%. Among the 487 participants in the ACSD who responded to the survey, 410 (84.2%) reported that TAVR was performed at their institutions. Approximately three-quarters reported that they performed TAVR procedures as part of a heart team (77.5%; 313 of 404), cardiologists and cardiothoracic surgeons were jointly responsible for TAVR referrals (83.7%; 339 of 405), and TAVR programs were administered either jointly by the cardiology and cardiac surgery departments or exclusively by the cardiac surgery department (73.3%; 297 of 405). A majority were involved in the pre-, intra-, and postoperative care of patients undergoing TAVR, with 91.4% (370 of 405) reporting participation in multidisciplinary meetings, at least 50% regularly performing technical aspects in 10 of 11 conduct of operation categories, and 86.6% (266 of 307) caring for patients undergoing TAVR after the procedure. Cardiac surgeons in the United States are active participants in the management of patients with aortic stenosis as part of the heart team. The STS survey found that not only were they actively involved in the treatment decision-making process but they also played a significant role in the valve procedure, including deployment and postprocedural care. The heart team model continues to evolve and should be expanded into other areas of structural heart disease. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Transcatheter closure of Patent Ductus Arteriosus through only venous route.

PubMed

Sheikh, Abdul Malik; Duke, Abdul Karim; Sattar, Hina

2018-03-01

Patent ductus arteriosus is a common congenital cardiac defect comprising 5-10% of all these defects in term neonates. Although open chest and video-assisted interruption are still in use, transcatheter occlusion has rapidly become the first choice for patent ductus arteriosus closure in the appropriate patient. Percutaneous closure of patent ductus arteriosus is widely done by transvenous approach guided by aortic access. We present the case of a 2 year old girl who underwent patent ductus arteriosus device occlusion with transvenous access only.

Computer-aided evaluation of low-dose and low-contrast agent third-generation dual-source CT angiography prior to transcatheter aortic valve implantation (TAVI).

PubMed

Dankerl, Peter; Hammon, Matthias; Seuss, Hannes; Tröbs, Monique; Schuhbaeck, Annika; Hell, Michaela M; Cavallaro, Alexander; Achenbach, Stephan; Uder, Michael; Marwan, Mohamed

2017-05-01

To evaluate the performance of computer-aided evaluation software for a comprehensive workup of patients prior to transcatheter aortic valve implantation (TAVI) using low-contrast agent and low radiation dose third-generation dual-source CT angiography. We evaluated 30 consecutive patients scheduled for TAVI. All patients underwent ECG-triggered high-pitch dual-source CT angiography of the aortic root and aorta with a standardized contrast agent volume (30 ml Imeron350, flow rate 4 ml/s) and low-dose (100 kv/350 mAs) protocol. An expert (10 years of experience) manually evaluated aortic root and iliac access dimensions (distance between coronary ostia and aortic annulus, minimal/maximal diameters and area-derived diameter of the aortic annulus) and best CT-predicted fluoroscopic projection angle as the reference standard. Utilizing computer-aided software (syngo.via), the same pre-TAVI workup was performed and compared to the reference standard. Mean CTDI[Formula: see text] was 3.46 mGy and mean DLP 217.6 ± 12.1 mGy cm, corresponding to a mean effective dose of 3.7 ± 0.2 mSv. Computer-aided evaluation was successful in all but one patient. Compared to the reference standard, Bland-Altman analysis indicated very good agreement for the distances between aortic annulus and coronary ostia (RCA: mean difference 0.8 mm; 95 % CI 0.4-1.2 mm; LM: mean difference 0.9 mm; 95 % CI 0.5-1.3 mm); however, we demonstrated a systematic overestimation of annulus- derived diameter using the software (mean difference 44.4 mm[Formula: see text]; 95 % CI 30.4-58.3 mm[Formula: see text]). Based on respective annulus dimensions, the recommended prosthesis size (Edwards SAPIEN 3) matched in 26 out of the 29 patients (90 %). CT-derived fluoroscopic projection angles showed an excellent agreement for both methods. Out of 58 iliac arteries, 15 (25 %) arteries could not be segmented by the software. Preprocessing time of the software was 71 ± 11 s (range 51-96�

A Retrospective Study of 1,526 Cases of Transcatheter Occlusion of Patent Ductus Arteriosus.

PubMed

Jin, Mei; Liang, Yong-Mei; Wang, Xiao-Fang; Guo, Bao-Jing; Zheng, Ke; Gu, Yan; Lyu, Zhen-Yu

2015-09-05

Patent ductus arteriosus (PDA) is one of the most common congenital heart diseases and began to get treated by transcatheter occlusion since 1997 in China. Since then, several devices have been invented for occluding PDA. This study aimed to evaluate the technical feasibility, safety, and efficacy of transcatheter occlusion of PDA with different devices. One thousand five hundred and twenty-six patients (537 boys, 989 girls) with PDA from January 1997 to September 2014 underwent descending aortogram and transcatheter occlusion procedure. We retrospectively analyzed data of these patients, including gender, age, weight, size and morphology of PDA, and devices used in transcatheter occlusion, outcomes, and postoperational complications. Median age and median weight were 4.0 years (range: 0.3-52.0 years old) and 15.3 kg (range: 4.5-91.0 kg), respectively. Mean ductal diameter, aortic ductal diameter, ductal length, and pulmonary artery pressure were 3.50 ± 2.15 mm, 10.08 ± 2.46 mm, 7.49 ± 3.02 mm, and 30.21 ± 17.28 mmHg, respectively. Morphology of PDA assessed by descending aortogram was of type A in 1428 patients, type B in 6 patients, type C in 79 patients, type D in 4 patients, and type E in 9 patients according to the classification of Krichenko. Of all the 1526 patients, 1497 patients underwent transcatheter PDA closure, among which 1492 were successful. Devices used were Amplatzer duct occluder I (ADO I, 1280, 85.8%), Cook detachable coils (116, 7.8%), ADO II (ADO II, 68, 4.6%), muscular VSD occluder (12, 0.8%), and Amplatzer vascular plug (16, 1.0%). Excellent occlusion rates with low complication rates were achieved with all devices regardless of PDA types. With transcatheter occlusion technique and devices developing, more patients with PDA can be treated with transcatheter closure both safely and efficiently.

Does three-dimensional transesophageal echocardiography provide incremental value in percutaneous closure of ascending aortic pseudoaneurysm?

PubMed

Elkaryoni, Ahmed; Hsiung, Ming C; Arisha, Mohammed J; Ahmad, Amier; Nanda, Navin C; Mohamed, Ahmed H; Attia, Doaa; Sachdeva, Ankush; Singh, Lovepreet; Yin, Wei-Hsian

2017-07-01

Ascending aortic pseudoaneurysms (AO PSAs), if left untreated, are complicated by a high rate of rupture resulting in significant morbidity and mortality. New transcatheter modalities have emerged as acceptable surgical alternatives for their management. We present a case of an ascending aortic PSA in which intraoperative two- and three-dimensional transesophageal echocardiography (2DTEE and 3DTEE) provided a comprehensive assessment of the PSA in pre- and postclosure settings. © 2017, Wiley Periodicals, Inc.

Bundle-branch reentry ventricular tachycardia after transcatheter aortic valve replacement

PubMed Central

de la Rosa Riestra, Adriana; Rubio Caballero, José Amador; Freites Estévez, Alfonso; Alonso Belló, Javier; Botas Rodríguez, Javier

2016-01-01

An 83-year-old male suffering from severe symptomatic aortic valve stenosis received an implant of a biological aortic prosthesis through the femoral artery without complications. Seven days after dischargement he experienced a syncope. The patient was wearing an ECG holter monitor that day, which showed a wide QRS complex tachycardia of 300 beats per minute. The electrophysiological study revealed a bundle-branch reentry ventricular tachycardia as the cause of the syncope. Radio-frequency was applied on the right-bundle branch. Twelve months later, the patient has remained asymptomatic. PMID:27134443

Efficacy of RADPAD® protection drape in reducing radiation exposure to the primary operator during Transcatheter Aortic Valve Implantation (TAVI).

PubMed

Sharma, Divyesh; Ramsewak, Adesh; Manoharan, Ganesh; Spence, Mark S

2016-02-01

The efficacy of RADPAD® (a sterile, lead-free drape) has been demonstrated to reduce the scatter radiation to the primary operator during fluoroscopic procedures. However, the use of the RADPAD® during TAVI procedures has not been studied. Transcatheter aortic valve implantation (TAVI) is now an established treatment for patients with symptomatic severe aortic stenosis who are deemed inoperable or at high risk for conventional surgical aortic valve replacement (AVR). Consequently the radiation exposure to the patient and the interventional team from this procedure has become a matter of interest and importance. Methods to reduce radiation exposure to the interventional team during this procedure should be actively investigated. In this single center prospective study, we determined the radiation dose during this procedure and the efficacy of RADPAD® in reducing the radiation dose to the primary operator. Fifty consecutive patients due to undergo elective TAVI procedures were identified. Patients were randomly assigned to undergo the procedure with or without the use of a RADPAD® drape. There were 25 patients in each group and dosimetry was performed at the left eye level of the primary operator. The dosimeter was commenced at the start of the procedure, and the dose was recorded immediately after the end of the procedure. Fluoroscopy times and DAP were also recorded prospectively. Twenty-five patients underwent transfemoral TAVI using a RADPAD® and 25 with no-RADPAD®. The mean primary operator radiation dose was significantly lower in the RADPAD group at 14.8 mSv vs. 24.3 mSv in the no-RADPAD group (P=0.008). There was no significant difference in fluoroscopy times or dose-area products between the two patient groups. The dose to the primary operator relative to fluoroscopy time (RADPAD: slope=0.325; no RADPAD: slope=1.148; analysis of covariance F=7.47, P=0.009) and dose area product (RADPAD: slope=0.0007; no RADPAD: slope=0.002; analysis of covariance F=7

Short- and long-term need for permanent pacemaker after transcatheter implantation of the Edwards Sapien aortic valve prosthesis.

PubMed

Moreno, Raúl; Calvo, Luis; Sánchez-Recalde, Angel; Galeote, Guillermo; Jiménez-Valero, Santiago; López, Teresa; Plaza, Ignacio; González-Davia, Rosa; Ramírez, Ulises; Mesa, Jose Maria; Moreno-Gomez, Isidro; López-Sendón, José-Luis

2015-11-01

A permanent pacemaker is frequently needed after transcatheter aortic valve implantation, but the available data are mainly on the CoreValve system. To evaluate the need for new permanent pacemaker after implantation of the Edwards Sapien device, as well as related factors. We included the first 100 patients treated with the Edwards Sapien device at our institution. Of these, 12 had a permanent pacemaker before the procedure, and thus our study population was the remaining 88 patients. A permanent pacemaker was indicated in eight patients (9.1%) during hospitalization or at 30 days. After discharge, another four patients needed a pacemaker (at 42 days and three, 18, and 30 months). Two variables were associated with the need for pacemaker during hospitalization: previous dialysis (13% vs. 1%, p=0.042) and complete right bundle branch block before the procedure (25% vs. 5%, p=0.032). More than one month after the procedure, the characteristics associated with the need for pacemaker were plasma creatinine level (2.5±1.7 vs. 1.3±0.6 mg/dl, p=0.001) and previous myocardial infarction (50% vs. 10%, p=0.013). The rate of pacemaker implantation with the Edwards Sapien device was 9.1%. Right bundle branch block and dialysis were associated with this complication.

First-in-man use of a novel embolic protection device for patients undergoing transcatheter aortic valve implantation.

PubMed

Naber, Christoph K; Ghanem, Alexander; Abizaid, Alexander A; Wolf, Alexander; Sinning, Jan-Malte; Werner, Nikos; Nickenig, Georg; Schmitz, Thomas; Grube, Eberhard

2012-05-15

We describe the first-in-human experience with a novel cerebral embolic protection device used during transcatheter aortic valve implantation (TAVI). One current challenge of TAVI is the reduction of procedural stroke. Procedural mobilisation of debris is a known source of cerebral embolisation. Mechanical protection by transient filtration of cerebral blood flow might reduce the embolic burden during TAVI. We aimed to evaluate the feasibility and safety of the Claret CE Pro™ cerebral protection device in patients undergoing TAVI. Patients scheduled for TAVI were prospectively enrolled at three centres. The Claret CE Pro™ (Claret Medical, Inc. Santa Rosa, CA, USA) cerebral protection device was placed via the right radial/brachial artery prior to TAVI and was removed after the procedure. The primary endpoint was technical success rate. Secondary endpoints encompassed procedural and 30-day stroke rates, as well as device-related complications. Deployment of the Claret CE Pro™ cerebral protection device was intended for use in 40 patients, 35 devices were implanted into the aortic arch. Technical success rate with delivery of the proximal and distal filter was 60% for the first generation device and 87% for the second-generation device. Delivery times for the first-generation device were 12.4±12.1 minutes and 4.4 ± 2.5 minutes for the second-generation device (p<0.05). The quantity of contrast used related to the Claret CE Pro System was 19.6 ± 3.8 ml. Captured debris was documented in at least 19 of 35 implanted devices (54.3%). No procedural transient ischaemic attacks, minor strokes or major strokes occurred. Thirty-day follow-up showed one minor stroke occurring 30 days after the procedure, and two major strokes both occurring well after the patient had completed TAVI. The use of the Claret CE Pro™ system is feasible and safe. Capture of debris in more than half of the patients provides evidence for the potential to reduce the procedural cerebral

The obesity paradox: An analysis of pre-procedure weight trajectory on survival outcomes in patients undergoing transcatheter aortic valve implantation.

PubMed

De Palma, Rodney; Ivarsson, John; Feldt, Kari; Saleh, Nawzad; Ruck, Andreas; Linder, Rikard; Settergren, Magnus

Increased mortality has been observed in those with cardiovascular diseases who are of normal body mass index (BMI) compared to the overweight and the obese. A similar association has been demonstrated in patients undergoing transcatheter aortic valve (TAVI) implantation. However, it still remains unclear whether low or normal BMI itself is unfavourable or whether this is merely a reflection of cardiac cachexia due to severe aortic stenosis. The hypothesis for the study was that weight change prior to TAVI may be associated with increased mortality following the procedure. Single centre retrospective analysis using the SWEDEHEART registry, national mortality statistics and local hospital database. Body mass index was used as the anthropomorphic measurement and patients grouped by WHO categories and weight change trajectory before and at TAVI. Kaplan-Meier survival was constructed and a Cox proportional hazard model used to evaluate predictors of outcome. Consecutive data on 493 patients with three year follow-up between 2008-2015 were evaluated. Overweight and obese body mass index categories (BMI>25) were associated with improved mortality compared to normal and underweight patients (BMI<25) (log rank p=0.02), hazard ratio of 0.68 (0.50-0.93). Weight loss trajectory was associated with increased mortality compared to stable weight (log rank p=0.01), hazard ratio 1.64 p=0.025. The pre-procedural weight trajectory of patients undergoing TAVI is an important predictor of clinical outcome after TAVI. Patients with stable weight trajectories are associated with improved mortality outcome compared to those with decreasing weight. Copyright © 2017 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

Accuracy and reproducibility of aortic annular measurements obtained from echocardiographic 3D manual and semi-automated software analyses in patients referred for transcatheter aortic valve implantation: implication for prosthesis size selection.

PubMed

Stella, Stefano; Italia, Leonardo; Geremia, Giulia; Rosa, Isabella; Ancona, Francesco; Marini, Claudia; Capogrosso, Cristina; Giglio, Manuela; Montorfano, Matteo; Latib, Azeem; Margonato, Alberto; Colombo, Antonio; Agricola, Eustachio

2018-02-06

A 3D transoesophageal echocardiography (3D-TOE) reconstruction tool has recently been introduced. The system automatically configures a geometric model of the aortic root and performs quantitative analysis of these structures. We compared the measurements of the aortic annulus (AA) obtained by semi-automated 3D-TOE quantitative software and manual analysis vs. multislice computed tomography (MSCT) ones. One hundred and seventy-five patients (mean age 81.3 ± 6.3 years, 77 men) who underwent both MSCT and 3D-TOE for annulus assessment before transcatheter aortic valve implantation were analysed. Hypothetical prosthetic valve sizing was evaluated using the 3D manual, semi-automated measurements using manufacturer-recommended CT-based sizing algorithm as gold standard. Good correlation between 3D-TOE methods vs. MSCT measurements was found, but the semi-automated analysis demonstrated slightly better correlations for AA major diameter (r = 0.89), perimeter (r = 0.89), and area (r = 0.85) (all P < 0.0001) than manual one. Both 3D methods underestimated the MSCT measurements, but semi-automated measurements showed narrower limits of agreement and lesser bias than manual measurements for most of AA parameters. On average, 3D-TOE semi-automated major diameter, area, and perimeter underestimated the respective MSCT measurements by 7.4%, 3.5%, and 4.4%, respectively, whereas minor diameter was overestimated by 0.3%. Moderate agreement for valve sizing for both 3D-TOE techniques was found: Kappa agreement 0.5 for both semi-automated and manual analysis. Interobserver and intraobserver agreements for the AA measurements were excellent for both techniques (intraclass correlation coefficients for all parameters >0.80). The 3D-TOE semi-automated analysis of AA is feasible and reliable and can be used in clinical practice as an alternative to MSCT for AA assessment. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author

Diagnostic Accuracy of Coronary Computed Tomography Before Aortic Valve Replacement: Systematic Review and Meta-Analysis.

PubMed

Chaikriangkrai, Kongkiat; Jhun, Hye Yeon; Shantha, Ghanshyam Palamaner Subash; Abdulhak, Aref Bin; Tandon, Rudhir; Alqasrawi, Musab; Klappa, Anthony; Pancholy, Samir; Deshmukh, Abhishek; Bhama, Jay; Sigurdsson, Gardar

2018-07-01

In aortic stenosis patients referred for surgical and transcatheter aortic valve replacement (AVR), the evidence of diagnostic accuracy of coronary computed tomography angiography (CCTA) has been limited. The objective of this study was to investigate the diagnostic accuracy of CCTA for significant coronary artery disease (CAD) in patients referred for AVR using invasive coronary angiography (ICA) as the gold standard. We searched databases for all diagnostic studies of CCTA in patients referred for AVR, which reported diagnostic testing characteristics on patient-based analysis required to pool summary sensitivity, specificity, positive-likelihood ratio, and negative-likelihood ratio. Significant CAD in both CCTA and ICA was defined by >50% stenosis in any coronary artery, coronary stent, or bypass graft. Thirteen studies evaluated 1498 patients (mean age, 74 y; 47% men; 76% transcatheter AVR). The pooled prevalence of significant stenosis determined by ICA was 43%. Hierarchical summary receiver-operating characteristic analysis demonstrated a summary area under curve of 0.96. The pooled sensitivity, specificity, and positive-likelihood and negative-likelihood ratios of CCTA in identifying significant stenosis determined by ICA were 95%, 79%, 4.48, and 0.06, respectively. In subgroup analysis, the diagnostic profiles of CCTA were comparable between surgical and transcatheter AVR. Despite the higher prevalence of significant CAD in patients with aortic stenosis than with other valvular heart diseases, our meta-analysis has shown that CCTA has a suitable diagnostic accuracy profile as a gatekeeper test for ICA. Our study illustrates a need for further study of the potential role of CCTA in preoperative planning for AVR.

The German Aortic Valve Registry (GARY): a nationwide registry for patients undergoing invasive therapy for severe aortic valve stenosis.

PubMed

Beckmann, A; Hamm, C; Figulla, H R; Cremer, J; Kuck, K H; Lange, R; Zahn, R; Sack, S; Schuler, G C; Walther, T; Beyersdorf, F; Böhm, M; Heusch, G; Funkat, A K; Meinertz, T; Neumann, T; Papoutsis, K; Schneider, S; Welz, A; Mohr, F W

2012-07-01

Background The increasing prevalence of severe aortic valve defects correlates with the increase of life expectancy. For decades, surgical aortic valve replacement (AVR), under the use of extracorporeal circulation, has been the gold standard for treatment of severe aortic valve diseases. In Germany ~12,000 patients receive isolated aortic valve surgery per year. For some time, percutaneous balloon valvuloplasty has been used as a palliative therapeutic option for very few patients. Currently, alternatives for the established surgical procedures such as transcatheter aortic valve implantation (TAVI) have become available, but there are only limited data from randomized studies or low-volume registries concerning long-time outcome. In Germany, the implementation of this new technology into hospital care increased rapidly in the past few years. Therefore, the German Aortic Valve Registry (GARY) was founded in July 2010 including all available therapeutic options and providing data from a large quantity of patients.Methods The GARY is assembled as a complete survey for all invasive therapies in patients with relevant aortic valve diseases. It evaluates the new therapeutic options and compares them to surgical AVR. The model for data acquisition is based on three data sources: source I, the mandatory German database for external performance measurement; source II, a specific registry dataset; and source III, a follow-up data sheet (generated by phone interview). Various procedures will be compared concerning observed complications, mortality, and quality of life up to 5 years after the initial procedure. Furthermore, the registry will enable a compilation of evidence-based indication criteria and, in addition, also a comparison of all approved operative procedures, such as Ross or David procedures, and the use of different mechanical or biological aortic valve prostheses.Results Since the launch of data acquisition in July 2010, almost all institutions performing

Aortic annulus sizing using watershed transform and morphological approach for CT images

NASA Astrophysics Data System (ADS)

Mohammad, Norhasmira; Omar, Zaid; Sahrim, Mus'ab

2018-02-01

Aortic valve disease occurs due to calcification deposits on the area of leaflets within the human heart. It is progressive over time where it can affect the mechanism of the heart valve. To avoid the risk of surgery for vulnerable patients especially senior citizens, a new method has been introduced: Transcatheter Aortic Valve Implantation (TAVI), which places a synthetic catheter within the patient's valve. This entails a procedure of aortic annulus sizing, which requires manual measurement of the scanned images acquired from Computed Tomographic (CT) by experts. The step requires intensive efforts, though human error may still eventually lead to false measurement. In this research, image processing techniques are implemented onto cardiac CT images to achieve an automated and accurate measurement of the heart annulus. The image is first put through pre-processing for noise filtration and image enhancement. Then, a marker image is computed using the combination of opening and closing operations where the foreground image is marked as a feature while the background image is set to zero. Marker image is used to control the watershed transformation and also to prevent oversegmentation. This transformation has the advantage of fast computational and oversegmentation problems, which usually appear with the watershed transform can be solved with the introduction of marker image. Finally, the measurement of aortic annulus from the image data is obtained through morphological operations. Results affirm the approach's ability to achieve accurate annulus measurements compared to conventional techniques.

Predictors of transient left ventricular dysfunction following transcatheter patent ductus arteriosus closure in pediatric age.

PubMed

Agha, Hala Mounir; Hamza, Hala S; Kotby, Alyaa; Ganzoury, Mona E L; Soliman, Nanies

2017-10-01

To evaluate the left ventricular function before and after transcatheter percutaneous patent ductus arteriosus (PDA) closure, and to identify the predictors of myocardial dysfunction post-PDA closure if present. Transcatheter PDA closure; conventional, Doppler, and tissue Doppler imaging; and speckle tracking echocardiography. To determine the feasibility and reliability of tissue Doppler and myocardial deformation imaging for evaluating myocardial function in children undergoing transcatheter PDA closure. Forty-two children diagnosed with hemodynamically significant PDA underwent percutaneous PDA closure. Conventional, Doppler, and tissue Doppler imaging, and speckle-derived strain rate echocardiography were performed at preclosure and at 48 hours, 1 month, and 6 months postclosure. Tissue Doppler velocities of the lateral and septal mitral valve annuli were obtained. Global and regional longitudinal peak systolic strain values were determined using two-dimensional speckle tracking echocardiography. The median age of the patients was 2 years and body weight was 15 kg, with the mean PDA diameter of 3.11 ± 0.99 mm. M-mode measurements (left ventricular end diastolic diameter, left atrium diameter to aortic annulus ratio, ejection fraction, and shortening fraction) reduced significantly early after PDA closure ( p  < 0.001). After 1 month, left ventricular end diastolic diameter and left atrium diameter to aortic annulus ratio continued to decrease, while ejection fraction and fractional shortening improved significantly. All tissue Doppler velocities showed a significant decrease at 48 hours with significant prolongation of global myocardial function ( p  < 0.001) and then were normalized within 1 month postclosure. Similarly, global longitudinal strain significantly decreased at 48 hours postclosure ( p  < 0.001), which also recovered at 1 month follow-up. Preclosure global longitudinal strain showed a good correlation with the postclosure

Diffusion-weighted MRI determined cerebral embolic infarction following transcatheter aortic valve implantation: assessment of predictive risk factors and the relationship to subsequent health status.

PubMed

Fairbairn, Timothy A; Mather, Adam N; Bijsterveld, Petra; Worthy, Gillian; Currie, Stuart; Goddard, Anthony J P; Blackman, Daniel J; Plein, Sven; Greenwood, John P

2012-01-01

'Silent' cerebral infarction and stroke are complications of transcatheter aortic valve implantation (TAVI). To assess the occurrence of cerebral infarction, identify predictive risk factors and examine the impact on patient health-related quality of life (HRQoL). Cerebral diffusion weighted MRI of 31 patients with aortic stenosis undergoing CoreValve TAVI was carried out. HRQoL was assessed at baseline and at 30 days by SF-12v2 and EQ5D questionnaires. New cerebral infarcts occurred in 24/31 patients (77%) and stroke in 2 (6%). Stroke was associated with a greater number and volume of cerebral infarcts. Age (r=0.37, p=0.042), severity of atheroma (arch and descending aorta; r=0.91, p<0.001, r=0.69, p=0.001, respectively) and catheterisation time (r=0.45, p=0.02) were predictors of the number of new cerebral infarcts. HRQoL improved overall: SF-12v2 physical component summary increased significantly (32.4±6.2 vs 36.5±7.2; p=0.03) with no significant change in mental component summary (43.5±11.7 vs. 43.1±14.3; p=0.85). The EQ5D score and Visual Analogue Scale showed no significant change (0.56±0.26 vs. 0.59±0.31; p=0.70, and 54.2±19 vs. 58.2±24; p=0.43). Multiple small cerebral infarcts occurred in 77% of patients with TAVI. The majority of infarcts were 'silent' with clinical stroke being associated with a both higher infarct number and volume. Increased age and the severity of aortic arch atheroma were independent risk factors for the development of new cerebral infarcts. Overall HRQoL improved and there was no association between the number of new cerebral infarcts and altered health status.

Non-invasive cerebral oxygenation reflects mixed venous oxygen saturation during the varying haemodynamic conditions in patients undergoing transapical transcatheter aortic valve implantation.

PubMed

Paarmann, Hauke; Heringlake, Matthias; Heinze, Hermann; Hanke, Thorsten; Sier, Holger; Karsten, Jan; Schön, Julika

2012-03-01

Transapical transcatheter aortic valve implantation (TA-TAVI) is increasingly used to treat aortic valve stenosis in high-risk patients. Mixed venous oxygen saturation (SvO(2)) is still the 'gold standard' for the determination of the systemic oxygen delivery to consumption ratio in cardiac surgery patients. Recent data suggest that regional cerebral oxygen saturation (rScO(2)) determined by near-infrared spectroscopy is closely related to SvO(2). The present study compares rScO(2) and SvO(2) in patients undergoing TA-TAVI. n = 20 cardiac surgery patients scheduled for TA-TAVI were enrolled in this prospective observational study. SvO(2) and rScO(2) were determined at predefined time points during the procedure. Correlation and Bland-Altman analysis of the complete data set showed a correlation coefficient of r(2 )= 0.7 between rScO(2) and SvO(2) (P < 0.0001), a mean difference (bias) of 5.8 with limits of agreement (1.96 SD) of -6.8 to 18.3% and a percentage error of 17.5%. At all predefined time points correlation was moderate (r(2 )= 0.50) to close (r = 0.84), and the percentage error was <24%. RScO(2) determined by near-infrared spectroscopy is correlated to SvO(2) during varying haemodynamic conditions in patients undergoing TA-TAVI. This suggests that rScO(2) is reflective not only of the cerebral, but also of the systemic oxygen balance.

The Prognostic Impact of New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Implantation: A Meta-analysis.

PubMed

Ando, Tomo; Takagi, Hisato

2016-09-01

New-onset persistent left bundle branch block (NOP-LBBB) is one of the most common conduction disturbances after transcatheter aortic valve implantation (TAVI). We hypothesized that NOP-LBBB may have a clinically negative impact after TAVI. To find out, we conducted a systematic literature search of the MEDLINE/PubMed and Embase databases. Observational studies that reported clinical outcomes of NOP-LBBB patients after TAVI were included. The random-effects model was used to combine odds ratios, risk ratios, or hazard ratios (HRs) with 95% confidence intervals. Adjusted HRs were utilized over unadjusted HRs or risk ratios when available. A total of 4049 patients (807 and 3242 patients with and without NOP-LBBB, respectively) were included. Perioperative (in-hospital or 30-day) and midterm all-cause mortality and midterm cardiovascular mortality were comparable between the groups. The NOP-LBBB patients experienced a higher rate of permanent pacemaker implantation (HR: 2.09, 95% confidence interval: 1.12-3.90, P = 0.021, I(2) = 83%) during midterm follow-up. We found that NOP-LBBB after TAVI resulted in higher permanent pacemaker implantation but did not negatively affect the midterm prognosis. Therefore, careful observation during the follow-up is required. © 2016 Wiley Periodicals, Inc.

Impact of Liver Indicators on Clinical Outcome in Patients Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Wendt, Daniel; Kahlert, Philipp; Canbay, Ali; Knipp, Stephan; Thoenes, Martin; Cremer, Gordina; Al-Rashid, Fadi; Jánosi, Rolf-Alexander; El-Chilali, Karim; Kamler, Markus; El Gabry, Mohamed; Marx, Philipp; Dohle, Daniel Sebastian; Tsagakis, Konstantinos; Benedik, Jaroslav; Gerken, Guido; Rassaf, Tienush; Jakob, Heinz; Thielmann, Matthias

2017-10-01

Liver dysfunction increases death and morbidity after cardiac operations. There are currently no data evaluating liver function in patients undergoing transcatheter aortic valve replacement (TAVR). We aimed therefore to evaluate our TAVR results in regard to liver function. A total of 640 consecutive TAVR patients were evaluated. Of those, 11 patients presented with chronic liver disease before TAVR. The Model for End-Stage Liver Disease score was used to measure liver function in these patients. The primary study end point was 30-day mortality in patients presenting with liver dysfunction. Secondary study end point was liver enzymes after TAVR. The mean Model for End-Stage Liver Disease score in patients with chronic liver disease was 16.8 ± 6.2 (median, 18; range, 7 to 26). The 30-day mortality was 9.1% (57 of 629) in patients presenting without liver disease and 9.1% (1 of 11) in patients with liver disease (p = 1.00). Patients with chronic liver disease showed significantly higher preoperative levels of γ-glutamyl transpeptidase (p < 0.001). After TAVR, we observed a significant increase in alanine aminotransferase on postoperative day 3 compared with preoperative values (p < 0.001), accompanied by a decrease in albumin (p < 0.001). Liver cirrhosis per se is not considered as a contraindication for cardiac operations. In the present study, we did not observe a higher 30-day mortality rate in liver cirrhotic patients undergoing TAVR, suggesting TAVR as a feasible alternative with acceptable outcomes in patients with chronic liver disease. Moreover, the present study is the first to evaluate liver variables in patients undergoing TAVR. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Importance of Geriatric Nutritional Risk Index assessment in patients undergoing transcatheter aortic valve replacement.

PubMed

Shibata, Kenichi; Yamamoto, Masanori; Kano, Seiji; Koyama, Yutaka; Shimura, Tetsuro; Kagase, Ai; Yamada, Sumio; Kobayashi, Toshihiro; Tada, Norio; Naganuma, Toru; Araki, Motoharu; Yamanaka, Futoshi; Shirai, Shinichi; Mizutani, Kazuki; Tabata, Minoru; Ueno, Hiroshi; Takagi, Kensuke; Higashimori, Akihiro; Watanabe, Yusuke; Otsuka, Toshiaki; Hayashida, Kentaro

2018-05-15

Nutritional condition is one marker of patients' frailty. The Geriatric Nutritional Risk Index (GNRI) is a well-known marker of nutritional status. This study sought to assess the clinical outcomes of GNRI after transcatheter aortic valve replacement (TAVR). We evaluated the GNRI value of 1,613 patients who underwent TAVR using data from a Japanese multicenter registry. According to baseline GNRI, patients were classified into 3 groups: GNRI ≥92 (n = 1,085; 67.3%), GNRI 82-92 (n = 396; 24.6%), and GNRI ≤82 (n = 132; 8.2%). Baseline characteristics, procedural outcomes, and cumulative mortality rates were compared. In addition, GNRI correlations with other frailty components (gait speed, grip strength, and Clinical Frailty Scale) and Society of Thoracic Surgeons (STS) score were also evaluated. Significantly increased mortality rates were observed across the 3 groups at 30 days (0.9%, 2.3%, and 6.8%, respectively; P < .001) and 1 year (6.5%, 16.4%, and 36.4%, respectively; P < .001). Both GNRI 82-92 and GNRI ≤82 (as a reference for GNRI ≥92) were independently associated with increased midterm mortality in the Cox regression multivariate model (hazard ratio: 1.97, 3.60; 95% confidence interval: 1.37-2.84, 2.30-5.64; P < .001, P < .001, respectively). The GNRI value was significantly correlated with gait speed (Spearman ρ = -0.15, P < .001), grip strength (ρ = 0.25, P < .001), Clinical Frailty Scale (ρ = -0.24, P < .001), and STS score (ρ = -0.29, P < .001). GNRI is related to both frailty components and the STS score and is an important surrogate marker for predicting worse clinical outcomes after TAVR. Assessment of the GNRI may be considered when deciding on TAVR. Copyright © 2018. Published by Elsevier Inc.

Very low intravenous contrast volume protocol for computed tomography angiography providing comprehensive cardiac and vascular assessment prior to transcatheter aortic valve replacement in patients with chronic kidney disease.

PubMed

Pulerwitz, Todd C; Khalique, Omar K; Nazif, Tamim N; Rozenshtein, Anna; Pearson, Gregory D N; Hahn, Rebecca T; Vahl, Torsten P; Kodali, Susheel K; George, Isaac; Leon, Martin B; D'Souza, Belinda; Po, Ming Jack; Einstein, Andrew J

2016-01-01

Transcatheter aortic valve replacement (TAVR) is a lifesaving procedure for many patients high risk for surgical aortic valve replacement. The prevalence of chronic kidney disease (CKD) is high in this population, and thus a very low contrast volume (VLCV) computed tomography angiography (CTA) protocol providing comprehensive cardiac and vascular imaging would be valuable. 52 patients with severe, symptomatic aortic valve disease, undergoing pre-TAVR CTA assessment from 2013-4 at Columbia University Medical Center were studied, including all 26 patients with CKD (eGFR<30 mL/min) who underwent a novel VLCV protocol (20 mL of iohexol at 2.5 mL/s), and 26 standard-contrast-volume (SCV) protocol patients. Using a 320-slice volumetric scanner, the protocol included ECG-gated volume scanning of the aortic root followed by medium-pitch helical vascular scanning through the femoral arteries. Two experienced cardiologists performed aortic annulus and root measurements. Vascular image quality was assessed by two radiologists using a 4-point scale. VLCV patients had mean (±SD) age 86 ± 6.5, BMI 23.9 ± 3.4 kg/m(2) with 54% men; SCV patients age 83 ± 8.8, BMI 28.7 ± 5.3 kg/m(2), 65% men. There was excellent intra- and inter-observer agreement for annular and root measurements, and excellent agreement with 3D-transesophageal echocardiographic measurements. Both radiologists found diagnostic-quality vascular imaging in 96% of VLCV and 100% of SCV cases, with excellent inter-observer agreement. This study is the first of its kind to report the feasibility and reproducibility of measurements for a VLCV protocol for comprehensive pre-TAVR CTA. There was excellent agreement of cardiac measurements and almost all studies were diagnostic quality for vascular access assessment. Copyright © 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

Bivalirudin Versus Heparin Anticoagulation in Transcatheter Aortic Valve Replacement: The Randomized BRAVO-3 Trial.

PubMed

Dangas, George D; Lefèvre, Thierry; Kupatt, Christian; Tchetche, Didier; Schäfer, Ulrich; Dumonteil, Nicolas; Webb, John G; Colombo, Antonio; Windecker, Stephan; Ten Berg, Jurriën M; Hildick-Smith, David; Mehran, Roxana; Boekstegers, Peter; Linke, Axel; Tron, Christophe; Van Belle, Eric; Asgar, Anita W; Fach, Andreas; Jeger, Raban; Sardella, Gennaro; Hink, Hans Ulrich; Husser, Oliver; Grube, Eberhard; Deliargyris, Efthymios N; Lechthaler, Ilknur; Bernstein, Debra; Wijngaard, Peter; Anthopoulos, Prodromos; Hengstenberg, Christian

2015-12-29

Anticoagulation is required during transcatheter aortic valve replacement (TAVR) procedures. Although an optimal regimen has not been determined, heparin is mainly used. Direct thrombin inhibition with bivalirudin may be an effective alternative to heparin as the procedural anticoagulant agent in this setting. The goal of this study was to determine whether bivalirudin offers an alternative to heparin as the procedural anticoagulant agent in patients undergoing TAVR. A total of 802 patients with aortic stenosis were randomized to undergo transfemoral TAVR with bivalirudin versus unfractionated heparin during the procedure. The 2 primary endpoints were major bleeding within 48 h or before hospital discharge (whichever occurred first) and 30-day net adverse clinical events, defined as the combination of major adverse cardiovascular events (all-cause mortality, myocardial infarction, or stroke) and major bleeding. Anticoagulation with bivalirudin versus heparin did not meet superiority because it did not result in significantly lower rates of major bleeding at 48 h (6.9% vs. 9.0%; relative risk: 0.77; 95% confidence interval [CI]: 0.48 to 1.23; p = 0.27) or net adverse cardiovascular events at 30 days (14.4% vs. 16.1%; relative risk: 0.89; 95% CI: 0.64 to 1.24; risk difference: -1.72; 95% CI: -6.70 to 3.25; p = 0.50); regarding the latter, the prespecified noninferiority hypothesis was met (pnoninferiority < 0.01). Rates of major adverse cardiovascular events at 48 h were not significantly different (3.5% vs. 4.8%; relative risk: 0.73; 95% CI: 0.37 to 1.43; p = 0.35). At 48 h, the bivalirudin group had significantly fewer myocardial infarctions but more acute kidney injury events than the heparin group; at 30 days, these differences were no longer significant. In this randomized trial of TAVR procedural pharmacotherapy, bivalirudin did not reduce rates of major bleeding at 48 h or net adverse cardiovascular events within 30 days compared with heparin. Although

Transcatheter Patent Ductus Arteriosus Occlusion in Small Infants.

PubMed

Schwartz, Matthew C; Nykanen, David; Winner, Lawrence H; Perez, Jose; McMahan, Michael; Munro, Hamish M; Suguna Narasimhulu, Sukumar

2016-12-01

Transcatheter patent ductus arteriosus (PDA) occlusion is feasible in small infants and may improve lung function in symptomatic patients. We aimed to describe transcatheter PDA closure in small infants including predictors of technical success and rate of complication and to identify factors associated with improved respiratory status after closure. All patients in the NICU at our center who were referred for transcatheter PDA occlusion between 1/2010 and 11/2014 were retrospectively identified. Relevant details were extracted. Additionally, a modification of the respiratory severity score (RSS) (FiO 2 × mean airway pressure) was used to characterize degree of pulmonary support before and at intervals after catheterization. Twenty patients were identified with median age of 96 days (13-247) and weight of 3.1 kg (1.7-4.7). The PDA was type F morphology in 14 (70%) patients. The PDA was successfully occluded in 16 (80%) patients. Ratio of minimum PDA diameter/length was >0.5 in all unsuccessful attempts and <0.4 in all successful cases (P = .01). Of the 16 cases of occlusion, Amplatzer Vascular Plug II was used in 15 (94%). No deaths or pulse loss occurred. Five (25%) patients required blood transfusion and transfusion was associated with lower hemoglobin (P = .049), lower weight (P = .008), and lower aortic pressure (P = .04). Excluding 1 patient with significant congenital heart disease, the RSS improved at 3 days in 9 (60%) patients and at 7 days in 12 (80%) compared with preintervention value. Patient factors were not associated with improved RSS at 3 or 7 days. In our cohort of symptomatic infants, transcatheter PDA occlusion was successful in most and a ratio of minimum PDA diameter/length of <0.4 was predictive of technical success. Using a surrogate for pulmonary support, the majority of patients were on less support 7 days after closure. © 2016 Wiley Periodicals, Inc.

[Early complications following transcatheter occlusion of perimembranous ventricular septal defects in children].

PubMed

Li, Jun-jie; Zhang, Zhi-wei; Qian, Ming-yang; Wang, Hui-shen; Li, Yu-fen

2006-11-01

To evaluate the early complications during and after transcatheter closure of perimembranous ventricular septal defects (PMVSDs) in children. A total of 223 patients received transcatheter closure of PMVSDs from March 2002 to December 2005 in our hospital were included in this retrospective study. The overall complications rate was 26.9% (60/223). Major complications occurred in 9 patients (4.0%) including III degrees atrioventricular block (AVB) in 2 (0.9%), hemolysis in 3 (1.3%) and surgical interventions in 4 patients (1.8%) because of device malposition (1), mild aortic regurgitation (2) and device embolization (1) and all 4 patients recovered without further complications. The 2 patients with III degrees AVB were completely recovered to normal sinus rhythm after 7 days treatment with temporary pacemaker and corticosteroid. Hemolysis in 3 patients disappeared after corticosteroid treatment. Minor complications occurred in 51 patients (22.8%) including bundle branch block (BBB) in 37 (16.6%), first-degree AVB in 2 (0.9%), second-degree AVB in 1 (0.4%), new-onset mild aortic regurgitation in 5 (2.2%) and new-onset mild to moderate tricuspid regurgitation in 6 patients (2.6%). Except for right bundle branch blocks, other BBBs were treated with albumin and corticosteroid and completely recovered. No treatment was applied for new-onset valve regurgitations. There was no death in all 223 patients. Early complications post PMVSDs in children are mostly minor with good prognosis and the prognosis for major complications post PMVSDs is good after proper treatment.

Pacemaker dependency after transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System.

PubMed

van der Boon, Robert M A; Van Mieghem, Nicolas M; Theuns, Dominic A; Nuis, Rutger-Jan; Nauta, Sjoerd T; Serruys, Patrick W; Jordaens, Luc; van Domburg, Ron T; de Jaegere, Peter P T

2013-09-30

To determine pacemaker (PM) dependency at follow-up visit in patients who underwent new permanent pacemaker implantation (PPI) following transcatheter aortic valve implantation (TAVI). Single center prospective observational study including 167 patients without previous PM implantation who underwent TAVI with the self-expanding Medtronic CoreValve System (MCS) between November 2005 and February 2011. PM dependency was defined by the presence of a high degree atrioventricular block (HDAVB; second [AV2] and third degree [AV3B]), or a slow (<30 bpm) or absent ventricular escape rhythm during follow-up PM interrogation. A total of 36 patients (21.6%) received a new PM following TAVI. The indication for PM was AV2B (n=2, 5.6%), AV3B (n=28, 77.8%), postoperative symptomatic bradycardia (n=3, 8.3%), brady-tachy syndrome (n=1, 2.8%), atrial fibrilation with slow response (n=1, 2.8%) and left bundle branch block (n=1, 2.8%). Long term follow-up was complete for all patients and ranged from 1 to 40 months (median (IQR): 11.5 (5.0-18.0 months). Of those patients with a HDAVB, 16 out of the 30 patients (53.3%) were PM independent at follow-up visit (complete or partial resolution of the AV conduction abnormality). Overall, 20 out of the 36 patients (55.6%) who received a new PM following TAVI were PM independent at follow-up. Partial and even complete resolution of peri-operative AV conduction abnormalities after MCS valve implantation occurred in more than half of the patients. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Impact of Antithrombotic Regimen on Mortality, Ischemic, and Bleeding Outcomes after Transcatheter Aortic Valve Replacement.

PubMed

Varshney, Anubodh; Watson, Ryan A; Noll, Andrew; Im, KyungAh; Rossi, Jeffrey; Shah, Pinak; Giugliano, Robert P

2018-05-19

Optimal antithrombotic therapy after transcatheter aortic valve replacement (TAVR) remains unclear. We evaluated the association between antithrombotic regimens and outcomes in TAVR patients. We retrospectively analyzed consecutive patients who underwent TAVR at a single academic center from April 2009 to March 2014. Antithrombotic regimens were classified as single or dual antiplatelet therapy (AP), single antiplatelet plus anticoagulant (SAC), or triple therapy (TT). The primary endpoint was a composite of death, myocardial infarction (MI), stroke, and major bleeding. Adjusted hazard ratios (HRs) were obtained with best subset variable selection methods using bootstrap resampling. Of 246 patients who underwent TAVR, 241 were eligible for analysis with 133, 88, and 20 patients in the AP, SAC, and TT groups, respectively. During a median 2.1-year follow-up, 53.5% had at least one endpoint-the most common was death (68%), followed by major bleeding (23%), stroke (6%), and MI (3%). At 2 years, the composite outcome occurred in 70% of TT, 42% of SAC, and 31% of AP patients. Compared to AP, adjusted HRs for the composite outcome were 2.88 [95% Confidence intervals (CI) (1.61-5.16); p = 0.0004] and 1.66 (95% CI [1.13-2.42]; p = 0.009) in the TT and SAC groups, respectively. Mortality rates at 2 years were 61% in the TT, 32% in the SAC, and 26% in the AP groups (p = 0.005). The risk of the composite outcome of death, MI, stroke, or major bleeding at 2-year follow-up was significantly higher in TAVR patients treated with TT or SAC versus AP, even after multivariate adjustment.

Transcaval approach for endovascular aortic interventions: A systematic review.

PubMed

Wee, Ian Jun Yan; Syn, Nicholas; Choong, Andrew M T L

2018-05-24

The caval-aortic path is a novel access route for endovascular aortic interventions in aortic interventions, particularly for patients unsuitable for traditional access routes including femoral, subclavian, transapical, and aortic. A systematic review was conducted as per the PRISMA guidelines utilizing three electronic databases: Medline, Embase, and Cochrane database. There were 10 studies identified, including 7 retrospective studies, 1 prospective cohort study, and 2 case reports. Data on 209 patients (mean age 79.5±5.1 years; 51.2% male) were abstracted including preoperative work-up, technical procedure details, and outcomes. The overall technical success rate for all procedures is 96.2%, with a 4.3% mortality rate and a mean follow up of 17.9±19.8 months. Individually in the various interventions, the technical success rate of transcaval endoleak repair and transcatheter aortic valve implantation (TAVI) was 94.4% and 97.5% respectively, with a low 30-day mortality rate of 7.6% in the TAVI intervention. There is encouraging evidence regarding the rates of mortality and complications in the transcaval approach for endovascular aortic interventions. It presents a feasible alternative for a judiciously select group of patients who are not suitable for other access routes. Copyright © 2018 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Conduction Abnormalities and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Device: The United Kingdom Experience.

PubMed

Rampat, Rajiv; Khawaja, M Zeeshan; Hilling-Smith, Roland; Byrne, Jonathan; MacCarthy, Philip; Blackman, Daniel J; Krishnamurthy, Arvindra; Gunarathne, Ashan; Kovac, Jan; Banning, Adrian; Kharbanda, Raj; Firoozi, Sami; Brecker, Stephen; Redwood, Simon; Bapat, Vinayak; Mullen, Michael; Aggarwal, Suneil; Manoharan, Ganesh; Spence, Mark S; Khogali, Saib; Dooley, Maureen; Cockburn, James; de Belder, Adam; Trivedi, Uday; Hildick-Smith, David

2017-06-26

The authors report the incidence of pacemaker implantation up to hospital discharge and the factors influencing pacing rate following implantation of the LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts) in the United Kingdom. Transcatheter aortic valve replacement (TAVR) is associated with a significant need for permanent pacemaker implantation. Pacing rates vary according to the device used. The REPRISE II (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System) trial reported a pacing rate of 29% at 30 days after implantation of the LOTUS device. Data were collected retrospectively on 228 patients who had the LOTUS device implanted between March 2013 and February 2015 across 10 centers in the United Kingdom. Twenty-seven patients (12%) had pacemakers implanted pre-procedure and were excluded from the analysis. Patients were aged 81.2 ± 7.7 years; 50.7% were male. The mean pre-procedural QRS duration was 101.7 ± 20.4 ms. More than one-half of the cohort (n = 111, 55%) developed new left bundle branch block (LBBB) following the procedure. Permanent pacemakers were implanted in 64 patients (32%) with a median time to insertion of 3.0 ± 3.4 days. Chief indications for pacing were atrioventricular (AV) block (n = 46, 72%), or LBBB with 1st degree AV block (n = 11, 17%). Amongst those who received a pacemaker following TAVR the pre-procedural electrocardiogram findings included: No conduction disturbance (n = 41, 64%); 1st degree AV block (n = 10, 16%); right bundle branch block (n = 6, 9%) and LBBB (n = 5, 8%). LBBB (but not permanent pacemaker) occurred more frequently in patients who had balloon aortic valvuloplasty before TAVR (odds ratio [OR]: 1.25; p = 0.03). Pre-procedural conduction abnormality (composite of 1st degree AV block, hemiblock, right bundle branch block, LBBB) was independently associated with the need for permanent pacemaker (OR: 2.54; p = 0.048). The absence of

Delirium as a Predictor of Physical and Cognitive Function in Individuals Aged 80 and Older After Transcatheter Aortic Valve Implantation or Surgical Aortic Valve Replacement.

PubMed

Eide, Leslie S P; Ranhoff, Anette H; Fridlund, Bengt; Haaverstad, Rune; Hufthammer, Karl Ove; Kuiper, Karel K J; Nordrehaug, Jan E; Norekvål, Tone M

2016-06-01

To determine how development of delirium after surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) could predict activity of daily living (ADL) and instrumental ADLs (IADL) disability, cognitive function, and self-reported health in individuals aged 80 and older. Prospective cohort study. Tertiary university hospital. Individuals aged 80 and older undergoing elective SAVR or TAVI (N = 136). Delirium was assessed for 5 days using the Confusion Assessment Method. The Barthel Index, Nottingham Extended ADL Scale, and SF-12 were used to determine ADL and IADL ability and self-reported health at baseline and 1- and 6-month follow-up. Cognition was assessed using the Mini-Mental State Examination at baseline and 6-month follow-up. Participants had lower IADL scores 1 month after SAVR than at baseline (baseline 58, 1 month: delirium 42, no delirium 50, P ≤ .02), but scores had returned to baseline levels at 6 months. The Medical Outcomes Study 12-item Short-Form Health Survey (SF-12) Physical Component Summary (PCS) score was higher at 6-month follow-up (48) than at baseline (39), especially in participants who did not develop delirium (P < .001). No differences in other outcomes were found. Regression models suggest that delirium may help predict IADL disability 1 month after baseline (P ≤ .07) but does not predict large differences in ADL disability, cognitive function, or SF-12-scores. Individuals who underwent TAVI and developed delirium had lower ADL (baseline 19, 1-month 16, P < .001) and IADL (baseline 49, 1-month 40, P = .003) scores at 1-month follow-up. SF-12 PCS score (baseline 30) increased from baseline to 1- (35, P = .04) and 6- (35, P = .02) month follow-up in individuals who underwent TAVI and did not develop delirium. Delirium after TAVI predicted greater ADL and IADL disability at 1-month but not at 6-month follow-up. Individuals who develop delirium after SAVR and TAVI have poorer short-term IADL function but

Forced diuresis with matched hydration in reducing acute kidney injury during transcatheter aortic valve implantation (Reduce-AKI): study protocol for a randomized sham-controlled trial.

PubMed

Arbel, Yaron; Ben-Assa, Eyal; Halkin, Amir; Keren, Gad; Schwartz, Arie Lorin; Havakuk, Ofer; Leshem-Rubinow, Eran; Konigstein, Maayan; Steinvil, Arie; Abramowitz, Yigal; Finkelstein, Ariel; Banai, Shmuel

2014-07-02

Acute kidney injury (AKI) is observed in up to 41% of patients undergoing transcatheter aortic valve implantation (TAVI) and is associated with increased risk for mortality. The aim of the present study is to evaluate whether furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system reduces AKI in patients undergoing TAVI. Reduce-AKI is a randomized sham-controlled study designed to examine the effect of an automated matched hydration system in the prevention of AKI in patients undergoing TAVI. Patients will be randomized in a 1:1 fashion to the RenalGuard system (active group) versus non-matched saline infusion (sham-controlled group). Both arms receive standard overnight saline infusion and N-acetyl cysteine before the procedure. The Reduce-AKI trial will investigate whether the use of automated forced diuresis with matched saline infusion is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVI. Clinicaltrials.gov: NCT01866800, 30 April 30 2013.

Evolution and prognostic impact of low flow after transcatheter aortic valve replacement.

PubMed

Le Ven, Florent; Thébault, Christophe; Dahou, Abdellaziz; Ribeiro, Henrique B; Capoulade, Romain; Mahjoub, Haïfa; Urena, Marina; Nombela-Franco, Luis; Allende Carrera, Ricardo; Clavel, Marie-Annick; Dumont, Éric; Dumesnil, Jean; De Larochellière, Robert; Rodés-Cabau, Josep; Pibarot, Philippe

2015-08-01

Low flow (LF), defined as stroke volume index (SVi) <35 mL/m(2), prior to the procedure has been recently identified as a powerful independent predictor of early and late mortality in patients undergoing transcatheter aortic valve replacement (TAVR). The objectives of this study were to determine the evolution of SVi following TAVR and to assess the determinants and impact on mortality of early postprocedural SVi (EP-SVi). We retrospectively analysed the clinical, Doppler echocardiographic and outcome data prospectively collected in 255 patients who underwent TAVR. Echocardiograms were performed before (baseline), within 5 days after procedure (early post procedure) and 6 months to 1 year following TAVR (late post procedure). Patients with EP-SVi <35 mL/m(2) (n=138; 54%) had increased mortality (HR 1.97, p=0.003) compared with those with EP-SVi ≥35 mL/m(2) (n=117; 46%). Furthermore, patients with baseline SVi (B-SVi) <35 mL/m(2) and EP-SVI ≥35 mL/m(2), that is, normalised flow, had better survival (HR 0.46, p=0.03) than those with both B-SVi and EP-SVi <35 mL/m(2), that is, persistent LF, and similar survival compared with those with both B-SVi and EP-SVi ≥35 mL/m(2), that is, maintained normal flow. In a multivariable model analysis, EP-SVi was independently associated with increased risk of mortality (HR 1.41 per 10 mL/m(2) decrease, p=0.03). The preprocedural/intraprocedural factors associated with lower EP-SVi were lower B-SVi (standardised β [β] 0.36, p<0.001) atrial fibrillation (β -0.13, p=0.02) and transapical approach (β -0.22, p<0.001). The measurement of EP-SVi is useful to assess the immediate haemodynamic benefit of TAVR and to predict the risk of late mortality. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The Melody® valve and Ensemble® delivery system for transcatheter pulmonary valve replacement

PubMed Central

McElhinney, Doff B; Hennesen, Jill T

2013-01-01

The Melody® transcatheter pulmonary valve (TPV) is a percutaneous valve system designed for the treatment of obstruction and/or regurgitation of prosthetic conduits placed between the right ventricle and pulmonary arteries in patients with congenital heart disease. In 2000, Melody TPV became the first transcatheter valve implanted in a human; in 2006 it became the first transcatheter valve commercially available anywhere in the world; and in 2010 it was launched as the first commercially available transcatheter valve in the United States. In this review, we present the clinical background against which the Melody valve was developed and implemented, introduce the rationale for and challenges of transcatheter valve technology for this population, outline the history and technical details of its development and use, and summarize currently available data concerning the performance of the device. PMID:23834411

The incidence and prognostic implications of worsening right ventricular function after surgical or transcatheter aortic valve replacement: insights from PARTNER IIA.

PubMed

Cremer, Paul C; Zhang, Yiran; Alu, Maria; Rodriguez, L Leonardo; Lindman, Brian R; Zajarias, Alan; Hahn, Rebecca T; Lerakis, Stamatios; Malaisrie, S Chris; Douglas, Pamela S; Pibarot, Philippe; Svensson, Lars G; Leon, Martin B; Jaber, Wael A

2018-05-08

In patients randomized to transcatheter or surgical aortic valve replacement (TAVR, SAVR), we sought to determine whether SAVR is associated with worsening right ventricular (RV) function and whether RV deterioration is associated with mortality. In 1376 patients from PARTNERIIA with paired baseline and 30-day core lab echocardiograms, worsening RV function was defined as decline by at least one grade from baseline to 30 days. Our primary outcome was all-cause mortality from 30 days to 2 years. Among 744 patients with TAVR, 62 (8.3%) had worsening RV function, compared with 156 of 632 patients with SAVR (24.7%) (P < 0.0001). In a multivariable model, SAVR [odds ratio (OR) 4.05, 95% confidence interval (CI) 2.55-6.44], a dilated RV (OR 2.38, 95% CI 1.37-4.14), and more than mild tricuspid regurgitation (TR) (OR 2.58, 95% CI 1.25-5.33) were associated with worsening RV function. There were 169 deaths, and patients with worsening RV function had higher all-cause mortality [hazard ratio (HR) 1.98, 95% CI 1.40-2.79]. This association remained robust after adjusting for clinical and echocardiographic variables. Among patients with worsening RV function, there was no mortality difference between TAVR and SAVR (HR 1.16, 95% CI 0.61-2.18). The development of moderate or severe RV dysfunction from baseline normal RV function conferred the worst prognosis (HR 2.87, 95% CI 1.40-5.89). After aortic valve replacement, worsening RV function is more common in patients with baseline RV dilation, more than mild TR, and in patients treated with SAVR. Worsening RV function and the magnitude of deterioration have important prognostic implications.

Safety of shorter length of hospital stay for patients undergoing minimalist transcatheter aortic valve replacement.

PubMed

Alkhalil, Ahmad; Lamba, Harveen; Deo, Salil; Bezerra, Hiram G; Patel, Sandeep M; Markowitz, Alan; Simon, Daniel I; Costa, Marco A; Davis, Angela C; Attizzani, Guilherme F

2018-02-01

Determine the feasibility and predictors of early discharge after minimalist transcatheter aortic valve replacement (TAVR). Duration of hospitalization has a direct impact on overall cost of care, but the clinical impact of length of stay (LOS) in patients undergoing minimalist TAVR remains unclear. We studied 268 patients who underwent minimalist TAVR. Short LOS (sLOS) was defined as post-procedural LOS ≤ 3 days and observed in 163 patients. Prolonged LOS (pLOS) was observed in 105 patients. Propensity score matching based on 39 variables yielded 54 pairs of patients in each group. We analyzed 30-day mortality, 30-day re-hospitalization and long-term survival data. Multivariate regression models were used to define predictors of sLOS. Thirty-day mortality was 0% versus 5.5% in the sLOS and pLOS groups, respectively (P = 0.08). Incidence of re-hospitalization was higher in pLOS (13% vs. 3.7%). sLOS was associated with lower odds ratio of minor vascular complication (OR 0.1 [95% CI: 0.01, 0.75], P = 0.05), any bleeding (OR 0.35 [95% CI: 0.14, 0.87], P = 0.02), blood transfusion (OR 0.27 [95% CI: 0.08, 0.81], P = 0.02), and new pacemaker implantation (OR 0.23 [95% CI: 0.1, 0.53], P < 0.001). Discharge to home had a significantly higher odd ratio for sLOS (OR 8.67 [95% CI: 3.59, 23.11], P < 0.001). In appropriately selected patients, sLOS following minimalist TAVR approach in an experienced and high volume center is feasible and safe. Implementing such a strategy may reduce medical costs with the potential clinical benefit of early re-habilitation for the elderly TAVR population. © 2017 Wiley Periodicals, Inc.

Minimalist transcatheter aortic valve replacement: The new standard for surgeons and cardiologists using transfemoral access?

PubMed

Jensen, Hanna A; Condado, Jose F; Devireddy, Chandan; Binongo, Jose; Leshnower, Bradley G; Babaliaros, Vasilis; Sarin, Eric L; Lerakis, Stamatios; Guyton, Robert A; Stewart, James P; Syed, Amjadullah Q; Mavromatis, Kreton; Kaebnick, Brian; Rajaei, Mohammad Hossein; Tsai, Lillian L; Rahman, Ayaz; Simone, Amy; Keegan, Patricia; Block, Peter C; Thourani, Vinod H

2015-10-01

A minimalist approach for transcatheter aortic valve replacement (MA-TAVR) utilizing transfemoral access under conscious sedation and transthoracic echocardiography is increasing in popularity. This relatively novel technique may necessitate a learning period to achieve proficiency in performing a successful and safe procedure. This report evaluates our MA-TAVR cohort with specific characterization between our early, midterm, and recent experience. We retrospectively reviewed 151 consecutive patients who underwent MA-TAVR with surgeons and interventionists equally as primary operator at Emory University between May 2012 and July 2014. Our institution had performed 300 TAVR procedures before implementation of MA-TAVR. Patient characteristics and early outcomes were compared using Valve Academic Research Consortium 2 definitions among 3 groups: group 1 included the first 50 patients, group 2 included patients 51 to 100, and group 3 included patients 101 to 151. Median age for all patients was 84 years and similar among groups. The majority of patients were men (56%) and the median ejection fraction for all patients was 55% (interquartile range, 38.0%-60.0%). The majority of patients were high-risk surgical candidates with a median Society of Thoracic Surgeons Predicted Risk of Mortality of 10.0% and similar among groups. The overall major stroke rate was 3.3%, major vascular complications occurred in 3% of patients, and greater-than-mild paravalvular leak rate was 7%. In-hospital mortality and morbidity were similar among all 3 groups. In a high-volume TAVR center, transition to MA-TAVR is feasible with acceptable outcomes and a diminutive procedural learning curve. We advocate for TAVR centers to actively pursue the minimalist technique with equal representation by cardiologists and surgeons. Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Flow Behavior in the Left Heart Ventricle Following Apico-Aortic Bypass Surgery

NASA Astrophysics Data System (ADS)

Shahriari, Shahrokh; Jeyhani, Morteza; Labrosse, Michel; Kadem, Lyes

2013-11-01

Apico-aortic bypass (AAB) surgery is an alternative for transcatheter aortic valve implantation (TAVI) to reduce left ventricle (LV) overload in patients with severe aortic stenosis (AS). It consists in connecting the apex of the LV to the descending thoracic aorta with a valved conduit. Postoperative flow assessments show that two thirds of the outflow is conducted from the LV apex to the conduit, while only one third crosses the native aortic valve. In this study, we performed high speed particle image velocimetry (PIV) measurements of flow pattern within an in vitro elastic model of LV in the presence of a very severe AS, before and after AAB. Results indicate that AAB effectively relieves the LV outflow obstruction; however, it also leads to abnormal ventricular flow patterns. Normal LV flow dynamics is characterized by an emerging mitral jet flow followed by the development of a vortical flow with velocities directed towards the aortic valve, while measurements in the presence of AAB show systolic flow bifurcating to the apical conduit and to the aortic valve outflow tract. This study provides the first insight into the LV flow structure after AAB including outflow jets and disturbed stagnation regions.

Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study.

PubMed

Baumbach, Andreas; Mullen, Michael; Brickman, Adam M; Aggarwal, Suneil K; Pietras, Cody G; Forrest, John K; Hildick-Smith, David; Meller, Stephanie M; Gambone, Louise; den Heijer, Peter; Margolis, Pauliina; Voros, Szilard; Lansky, Alexandra J

2015-05-01

This study aimed to evaluate the safety and performance of the TriGuard™ Embolic Deflection Device (EDD), a nitinol mesh filter positioned in the aortic arch across all three major cerebral artery take-offs to deflect emboli away from the cerebral circulation, in patients undergoing transcatheter aortic valve replacement (TAVR). The prospective, multicentre DEFLECT I study (NCT01448421) enrolled 37 consecutive subjects undergoing TAVR with the TriGuard EDD. Subjects underwent clinical and cognitive follow-up to 30 days; cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed pre-procedure and at 4±2 days post procedure. The device performed as intended with successful cerebral coverage in 80% (28/35) of cases. The primary safety endpoint (in-hospital EDD device- or EDD procedure-related cardiovascular mortality, major stroke disability, life-threatening bleeding, distal embolisation, major vascular complications, or need for acute cardiac surgery) occurred in 8.1% of subjects (VARC-defined two life-threatening bleeds and one vascular complication). The presence of new cerebral ischaemic lesions on post-procedure DW-MRI (n=28) was similar to historical controls (82% vs. 76%, p=NS). However, an exploratory analysis found that per-patient total lesion volume was 34% lower than reported historical data (0.2 vs. 0.3 cm3), and 89% lower in patients with complete (n=17) versus incomplete (n=10) cerebral vessel coverage (0.05 vs. 0.45 cm3, p=0.016). Use of the first-generation TriGuard EDD during TAVR is safe, and device performance was successful in 80% of cases during the highest embolic-risk portions of the TAVR procedure. The potential of the TriGuard EDD to reduce total cerebral ischaemic burden merits further randomised investigation.

[Commentary by the German Society for Thoracic and Cardiovascular Surgery on the positions statement by the German Cardiology Society on quality criteria for transcatheter aortic valve implantation (TAVI)].

PubMed

Cremer, Jochen; Heinemann, Markus K; Mohr, Friedrich Wilhelm; Diegeler, Anno; Beyersdorf, Friedhelm; Niehaus, Heidi; Ensminger, Stephan; Schlensak, Christian; Reichenspurner, Hermann; Rastan, Ardawan; Trummer, Georg; Walther, Thomas; Lange, Rüdiger; Falk, Volkmar; Beckmann, Andreas; Welz, Armin

2014-12-01

Surgical aortic valve replacement is still considered the first-line treatment for patients suffering from severe aortic valve stenosis. In recent years, transcatheter aortic valve implantation (TAVI) has emerged as an alternative for selected high-risk patients. According to the latest results of the German external quality assurance program, mandatory by law, the initially very high mortality and procedural morbidity have now decreased to approximately 6 and 12%, respectively. Especially in Germany, the number of patients treated by TAVI has increased exponentially. In 2013, a total of 10.602 TAVI procedures were performed. TAVI is claimed to be minimally invasive. This is true concerning the access, but it does not describe the genuine complexity of the procedure, defined by the close neighborhood of the aortic valve to delicate intracardiac structures. Hence, significant numbers of life-threatening complications may occur and have been reported. Owing to the complexity of TAVI, there is a unanimous concordance between cardiologists and cardiac surgeons in the Western world demanding a close heart team approach for patient selection, intervention, handling of complications, and pre- as well as postprocedural care, respectively. The prerequisite is that TAVI should not be performed in centers with no cardiac surgery on site. This is emphasized in all international joint guidelines and expert consensus statements. Today, a small number of patients undergo TAVI procedures in German hospitals without a department of cardiac surgery on site. To be noted, most of these hospitals perform less than 20 cases per year. Recently, the German Cardiac Society (DGK) published a position paper supporting this practice pattern. Contrary to this statement and concerned about the safety of patients treated this way, the German Society for Thoracic and Cardiovascular Surgery (DGTHG) still fully endorses the European (ESC/EACTS) and other actual international guidelines and

In Vitro Hydrodynamic Assessment of a New Transcatheter Heart Valve Concept (the TRISKELE).

PubMed

Rahmani, Benyamin; Tzamtzis, Spyros; Sheridan, Rose; Mullen, Michael J; Yap, John; Seifalian, Alexander M; Burriesci, Gaetano

2017-04-01

This study presents the in vitro hydrodynamic assessment of the TRISKELE, a new system suitable for transcatheter aortic valve implantation (TAVI), aiming to mitigate the procedural challenges experienced with current technologies. The TRISKELE valve comprises three polymeric leaflet and an adaptive sealing cuff, supported by a novel fully retrievable self-expanding nitinol wire frame. Valve prototypes were manufactured in three sizes of 23, 26, and 29 mm by automated dip-coating of a biostable polymer, and tested in a hydrodynamic bench setup in mock aortic roots of 21, 23, 25, and 27 mm annulus, and compared to two reference valves suitable for equivalent implantation ranges: Edwards SAPIEN XT and Medtronic CoreValve. The TRISKELE valves demonstrated a global hydrodynamic performance comparable or superior to the controls with significant reduction in paravalvular leakage. The TRISKELE valve exhibits enhanced anchoring and improved sealing. The valve is currently under preclinical investigation.

Value of a noise-optimized virtual monoenergetic reconstruction technique in dual-energy CT for planning of transcatheter aortic valve replacement.

PubMed

Martin, Simon S; Albrecht, Moritz H; Wichmann, Julian L; Hüsers, Kristina; Scholtz, Jan-Erik; Booz, Christian; Bodelle, Boris; Bauer, Ralf W; Metzger, Sarah C; Vogl, Thomas J; Lehnert, Thomas

2017-02-01

To evaluate objective and subjective image quality of a noise-optimized virtual monoenergetic imaging (VMI+) reconstruction technique in dual-energy computed tomography (DECT) angiography prior to transcatheter aortic valve replacement (TAVR). Datasets of 47 patients (35 men; 64.1 ± 10.9 years) who underwent DECT angiography of heart and vascular access prior to TAVR were reconstructed with standard linear blending (F_0.5), VMI+, and traditional monoenergetic (VMI) algorithms in 10-keV intervals from 40-100 keV. Signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of 564 arterial segments were evaluated. Subjective analysis was rated by three blinded observers using a Likert scale. Mean SNR and CNR were highest in 40 keV VMI+ series (SNR, 27.8 ± 13.0; CNR, 26.3 ± 12.7), significantly (all p < 0.001) superior to all VMI series, which showed highest values at 70 keV (SNR, 18.5 ± 7.6; CNR, 16.0 ± 7.4), as well as linearly-blended F_0.5 series (SNR, 16.8 ± 7.3; CNR, 13.6 ± 6.9). Highest subjective image quality scores were observed for 40, 50, and 60 keV VMI+ reconstructions (all p > 0.05), significantly superior to all VMI and standard linearly-blended images (all p < 0.01). Low-keV VMI+ reconstructions significantly increase CNR and SNR compared to VMI and standard linear-blending image reconstruction and improve subjective image quality in preprocedural DECT angiography in the context of TAVR planning. • VMI+ combines increased contrast with reduced image noise. • VMI+ shows substantially less image noise than traditional VMI. • 40-keV reconstructions show highest SNR/CNR of the aortic and iliofemoral access route. • Observers overall prefer 60 keV VMI+ images. • VMI+ DECT imaging helps improve image quality for TAVR planning.

Transcatheter closure of post-operative residual ventricular septal defect using a patent ductus arteriosus closure device in an adult: a case report.

PubMed

Djer, Mulyadi M; Idris, Nikmah S; Alwi, Idrus; Wijaya, Ika P

2014-07-01

Transcatheter closure of perimembranous and muscular ventricular septal defect (VSD) has been performed widely and it has more advantages compare to surgery. However, transcatheter closure of residual VSD post operation of complex congenital heart disease is still challenging because of the complexity of anatomy and concern about device stability, so the operator should meticulously choose the most appropriate technique and device. We would like to report a case of transcatheter closure of residual VSD post Rastelli operation in a patient with double outlet right ventricle (DORV), sub-aortic VSD, severe infundibulum pulmonary stenosis (PS) and single coronary artery. The patient had undergone operations for four times, but he still had intractable heart failure that did not response to medications. On the first attempt. we closed the VSD using a VSD occluder, unfortunately the device embolized into the descending aorta, but fortunately we was able to snare it out. Then we decided to close the VSD using a patent ductus arteriosus (PDA occluder). On transesophageal echocardiography (TEE) and angiography evaluation, the device position was stable. Post transcatheter VSD closure, the patient clinical condition improved significantly and he could finally be discharged after a long post-surgery hospitalization. Based on this experience we concluded that the transcatheter closure of residual VSD in complex CHD using PDA occluder could be an effective alternative treatment.

Cost comparison of transcatheter and operative closures of ostium secundum atrial septal defects

PubMed Central

O’Byrne, Michael L.; Gillespie, Matthew J.; Shinohara, Russell T.; Dori, Yoav; Rome, Jonathan J.; Glatz, Andrew C.

2015-01-01

Background Clinical outcomes for transcatheter and operative closures of atrial septal defects (ASDs) are similar. Economic cost for each method has not been well described. Methods A single-center retrospective cohort study of children and adults <30 years of age undergoing closure for single secundum ASD from January 1, 2007, to April 1, 2012, was performed to measure differences in inflation-adjusted cost of operative and transcatheter closures of ASD. A propensity score weight-adjusted multivariate regression model was used in an intention-to-treat analysis. Costs for reintervention and crossover admissions were included in primary analysis. Results A total of 244 subjects were included in the study (64% transcatheter and 36% operative), of which 2% (n = 5) were ≥18 years. Crossover rate from transcatheter to operative group was 3%. Risk of reintervention (P = .66) and 30-day mortality (P = .37) were not significantly different. In a multivariate model, adjusted cost of operative closure was 2012 US $60,992 versus 2012 US $55,841 for transcatheter closure (P < .001). Components of total cost favoring transcatheter closure were length of stay, medications, and follow-up radiologic and laboratory testing, overcoming higher costs of procedure and echocardiography. Professional costs did not differ. The rate of 30-day readmission was greater in the operative cohort, further increasing the cost advantage of transcatheter closure. Sensitivity analyses demonstrated that costs of follow-up visits influenced relative cost but that device closure remained favorable over a broad range of crossover and reintervention rates. Conclusion For single secundum ASD, cost comparison analysis favors transcatheter closure over the short term. The cost of follow-up regimens influences the cost advantage of transcatheter closure. PMID:25965721

Perforation of the right aortic valve cusp: complication of ventricular septal defect closure with a modified Rashkind umbrella.

PubMed

Vogel, M; Rigby, M L; Shore, D

1996-01-01

An 18-month-old boy with a perimembranous ventricular septal defect (VSD) had undergone transcatheter closure of the defect with a modified 17 mm Rashkind umbrella device at age 4 months (weight 3.8 kg). The clinical signs of a VSD persisted, and he developed aortic incompetence, first detected 5 months after the procedure, which progressed from mild to moderate. A three-dimensional echocardiographic study demonstrated that one of the four arms holding the umbrella was protruding into the aortic valve and had perforated the right aortic valve cusp. This diagnosis was confirmed at subsequent surgery. Surgical repair of the perforated right aortic valve leaflet was necessary. The umbrella was adherent to the tricuspid valve and could not be removed. Instead it was left in situ, but three of the stainless steel arms were cut off. When umbrella closure of a perimembranous VSD is undertaken, the close proximity of part of the distal umbrella to the aortic valve can lead to aortic regurgitation.

Impact of anticoagulation therapy on valve haemodynamic deterioration following transcatheter aortic valve replacement.

PubMed

Del Trigo, María; Muñoz-García, Antonio J; Latib, Azeem; Auffret, Vincent; Wijeysundera, Harindra C; Nombela-Franco, Luis; Gutierrez, Enrique; Cheema, Asim N; Serra, Vicenç; Amat-Santos, Ignacio J; Kefer, Joelle; Benitez, Luis Miguel; Leclercq, Florence; Mangieri, Antonio; Le Breton, Hervé; Jiménez-Quevedo, Pilar; Garcia Del Blanco, Bruno; Dager, Antonio; Abdul-Jawad Altisent, Omar; Puri, Rishi; Pibarot, Philippe; Rodés-Cabau, Josep

2018-05-01

To evaluate the changes in transvalvular gradients and the incidence of valve haemodynamic deterioration (VHD) following transcatheter aortic valve replacement (TAVR), according to use of anticoagulation therapy. This multicentre study included 2466 patients (46% men; mean age 81±7 years) who underwent TAVR with echocardiography performed at 12-month follow-up. Anticoagulation therapy was used in 707 patients (28.7%) following TAVR (AC group). A total of 663 patients received vitamin K antagonists, and 44 patients received direct oral anticoagulants. A propensity score matching analysis was performed to adjust for intergroup (AC vs non-AC post-TAVR) differences. A total of 622 patients per group were included in the propensity-matched analysis. VHD was defined as a ≥10 mm Hg increase in the mean transprosthetic gradient at follow-up (vs hospital discharge). The mean clinical follow-up was 29±18 months. The mean transvalvular gradient significantly increased at follow-up in the non-AC group within the global cohort (P=0.003), whereas it remained stable over time in the AC group (P=0.323). The incidence of VHD was significantly lower in the AC group (0.6%) compared with the non-AC group (3.7%, P<0.001), and these significant differences remained within the propensity-matched populations (0.6% vs 3.9% in the AC and non-AC groups, respectively, P<0.001). The occurrence of VHD did not associate with an increased risk of all-cause death (P=0.468), cardiovascular death (P=0.539) or stroke (P=0.170) at follow-up. The lack of anticoagulation therapy post-TAVR was associated with significant increments in transvalvular gradients and a greater risk of VHD. VHD was subclinical in most cases and did not associate with major adverse clinical events. Future randomised trials are needed to determine if systematic anticoagulation therapy post-TAVR would reduce the incidence of VHD. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article

Pseudomonas aeruginosa Infective Endocarditis Following Aortic Valve Implantation: A Note of Caution

PubMed Central

Dapás, Juan Ignacio; Rivero, Cynthia; Burgos, Pablo; Vila, Andrea

2016-01-01

Transcatheter aortic valve implantation (TAVI) is an alternative treatment for severe aortic valve stenosis (AS) in patients with prohibitive risk for surgical aortic valve replacement (SAVR). Prosthetic valve endocarditis (PVE) is a rare complication of this relatively novel procedure and current guidelines do not include specific recommendations for its treatment. We report a case of PVE due to Pseudomonas aeruginosa after TAVI that required SAVR, with successful outcome. PVE usually occurs during the first year after TAVI and entails a high mortality risk because patients eligible for this min-imally invasive procedure are fragile (i.e. advanced age and/or severe comorbidities). Additionally, clinical presentation may be atypical or subtle and transesophageal echocardiogram (TEE) may not be conclusive, which delays diagnosis and treatment worsening the prognosis. This case highlights that open SAVR might be ultimately indicated as part of treatment for TAVI-PVE despite a high-risk surgery score. PMID:27014375

Predictive ability of the CHADS2 and CHA2DS2-VASc scores for stroke after transcatheter aortic balloon-expandable valve implantation: an Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER) sub-analysis.

PubMed

Conrotto, Federico; D'Ascenzo, Fabrizio; D'Onofrio, Augusto; Agrifoglio, Marco; Chieffo, Alaide; Cioni, Micaela; Regesta, Tommaso; Tarantini, Giuseppe; Gabbieri, Davide; Saia, Francesco; Tamburino, Corrado; Ribichini, Flavio; Cugola, Diego; Aiello, Marco; Sanna, Francesco; Iadanza, Alessandro; Pompei, Esmeralda; Stolcova, Miroslava; Cappai, Antioco; Minati, Alessandro; Cassese, Mauro; Martinelli, Gian Luca; Agostinelli, Andrea; Gerosa, Gino; Gaita, Fiorenzo; Rinaldi, Mauro; Salizzoni, Stefano

2016-11-01

Stroke incidence after transcatheter aortic valve implantation (TAVI) still represents a concern. This multicentre study aimed at investigating the hypothesis that CHADS2 and CHA2DS2-VASc scores may be used to predict perioperative stroke after TAVI. The Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER) is a multicentre, prospective registry of patients undergoing balloon-expandable TAVI using Edwards Sapien and Sapien XT prosthesis between 2007 and 2012. The primary end-point of this study was the 30-day stroke rate. Secondary safety end-points were all the major adverse events based on Valve Academic Research Consortium (VARC-2) criteria. One thousand nine hundred and four patients were enrolled in the registry. Mean age was 81.6 ± 6.2 years and 1147 (60.2%) patients were female; mean CHADS 2 and CHA 2 DS 2 -VASc scores were 2.2 ± 0.8 and 4.4 ± 1.1, respectively. Fifty-four (2.8%) patients had a stroke within 30 days. At multivariable logistic regression analysis, CHA 2 DS 2 -VASc (OR: 1.35, 95% CI: 1.03-1.78; P = 0.031) and previous cardiac surgery (OR: 1.96, 95% CI: 1.06-3.6; P = 0.033) but not CHADS 2 (OR: 1.05, 95% CI: 0.76-1.44; P = 0.77) were found to be independent predictors of in-hospital stroke. A CHA 2 DS 2 -VASc score ≥5 was strongly related to the occurrence of in-hospital stroke (OR: 2.51, 95% CI: 1.38-4.57; P= 0.001). However, CHA 2 DS 2 -VASc score showed only poor accuracy for in-hospital stroke with a trend for better accuracy when compared with CHADS 2 score (area under the curve: 0.61, 95% CI: 0.59-0.63 vs 0.51; 95% CI: 0.49-0.54, respectively, P = 0.092). In TAVI patients, CHA 2 DS 2 -VASc provided a strong correlation for in-hospital stroke but with low accuracy. Dedicated scores to properly tailor procedures and preventive strategies are needed. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Feature-based US to CT registration of the aortic root

NASA Astrophysics Data System (ADS)

Lang, Pencilla; Chen, Elvis C. S.; Guiraudon, Gerard M.; Jones, Doug L.; Bainbridge, Daniel; Chu, Michael W.; Drangova, Maria; Hata, Noby; Jain, Ameet; Peters, Terry M.

2011-03-01

A feature-based registration was developed to align biplane and tracked ultrasound images of the aortic root with a preoperative CT volume. In transcatheter aortic valve replacement, a prosthetic valve is inserted into the aortic annulus via a catheter. Poor anatomical visualization of the aortic root region can result in incorrect positioning, leading to significant morbidity and mortality. Registration of pre-operative CT to transesophageal ultrasound and fluoroscopy images is a major step towards providing augmented image guidance for this procedure. The proposed registration approach uses an iterative closest point algorithm to register a surface mesh generated from CT to 3D US points reconstructed from a single biplane US acquisition, or multiple tracked US images. The use of a single simultaneous acquisition biplane image eliminates reconstruction error introduced by cardiac gating and TEE probe tracking, creating potential for real-time intra-operative registration. A simple initialization procedure is used to minimize changes to operating room workflow. The algorithm is tested on images acquired from excised porcine hearts. Results demonstrate a clinically acceptable accuracy of 2.6mm and 5mm for tracked US to CT and biplane US to CT registration respectively.

Impact of pacemaker mode in patients with atrioventricular conduction disturbance after trans-catheter aortic valve implantation.

PubMed

Takahashi, Masao; Badenco, Nicolas; Monteau, Jacques; Gandjbakhch, Estelle; Extramiana, Fabrice; Urena, Marina; Karam, Nicole; Marijon, Eloi; Algalarrondo, Vincent; Teiger, Emmanuel; Lellouche, Nicolas

2018-03-14

This study aimed to assess the impact of pacemaker mode programming on clinical outcomes in patients with high-degree atrioventricular conduction disturbance (AVCD) after transcatheter aortic valve implantation (TAVI). Although high-degree AVCD after TAVI can receive pacemaker, recovery of the AVCD is often observed. Specific pacemaker algorithms (AAI-DDD mode switch) are available which favor spontaneous atrioventricular conduction. Of 1,621 consecutive multi-center TAVI patients, 269 (16.4%) received pacemaker. We retrospectively included 91 patients with persistent high-degree AVCD at hospital discharge. Pacemaker dependency was defined as absence, inadequate intrinsic ventricular rhythm, or ventricular pacing time > 95% on pacemaker interrogation during follow-up. Comparison of heart failure hospitalization and death between conventional DDD (cDDD) and other modes was examined (AAI-DDD and VVI). During a mean follow-up duration of 13 months, the pacemaker dependency rate was 52.8%. Patients with cDDD mode (N = 36: 40.0%) had significantly more pacemaker dependency. Multivariate analysis showed that cDDD mode was independently associated with pacemaker dependency (odds ratio = 3.63, P = 0.03). Moreover, cDDD patients had a significant higher incidence of heart failure hospitalization (Hospitalization: cDDD vs. others = 45.4% vs. 18.2%, P = 0.03) and had a higher incidence of mortality (Death: cDDD vs. the others = 27.0% vs. 4.4%, P = 0.06). Up to half of patients implanted for high-degree AVCD after TAVI had conduction recovery. Patients with cDDD programming at hospital discharge had more pacemaker dependency and a worse cardiac prognosis. Thus, pacemaker mode should be systematically set to promote spontaneous atrioventricular conduction in patients with pacemaker implantation after TAVI. © 2018 Wiley Periodicals, Inc.

Description and Validation of TAVIApp: A Novel Mobile Application for Support of Physicians in the Management of Aortic Stenosis—Management of Aortic Stenosis with TAVIApp

PubMed Central

Sabatino, Jolanda; Mongiardo, Annalisa; Ricci, Pietrantonio; Spaccarotella, Carmen

2017-01-01

Background Aortic stenosis (AS) is the most common heart valve disease in developed countries. The advent of transcatheter aortic valve implantation (TAVI) significantly improved patients' outcome but made clinical management more complex. The aim of the present study was to describe TAVIApp, a mobile app we developed to guide the management of AS, and test its efficacy. Methods and Results Clinical cases comprising 42 patients with AS were blindly evaluated by (A) an interventional cardiologist, assisted by the Heart Team (EXPERT), (B) young residents in cardiology, and (C) a young resident supported by TAVIApp. There was poor concordance between Group A and Group B with low performance by young residents (k = 0.52; p < 0.001). However, concordance increased to an optimal value when young residents were supported by TAVIApp (k = 1.0; p < 0.001) for the diagnosis of severe AS and eligibility assessment. Furthermore, regarding the selection of the most appropriate prosthesis size, concordance to Group A was poor without TAVIApp support (Group B) (k = 0.78; p = 0.430), but excellent with TAVIApp (k = 1.0; p < 0.001). Conclusions This study is the first describing and validating a new mobile application to support the management of AS. TAVIApp supports cardiologists in the evaluation of stenosis severity, eligibility for TAVI or AVR, and selection of the most appropriate prosthesis size in individual patients. PMID:29270437

Avoidance of urinary catheterization to minimize in-hospital complications after transcatheter aortic valve implantation: An observational study.

PubMed

Lauck, Sandra B; Kwon, Jae-Yung; Wood, David A; Baumbusch, Jennifer; Norekvål, Tone M; Htun, Nay; Stephenson, Leo; Webb, John G

2018-01-01

Contemporary transcatheter aortic valve implantation (TAVI) devices and approach present opportunities to review historical practices initially informed by early treatment development and cardiac surgery. The avoidance of urinary catheterization in the older TAVI population is a strategy to minimize in-hospital complications. The purpose of the study was to explore elimination-related complications following the phased implementation of a default strategy of avoiding urinary catheterization in patients undergoing transfemoral (TF) TAVI. We conducted an observational study using a retrospective chart review of patients treated between 2011 and 2013 to identify patient characteristics, peri-procedure details, in-hospital outcomes and elimination-related complications in patients who did or did not receive a peri-procedure indwelling catheter. Descriptive analyses were used to report differences between the groups; we conducted a regression analysis to explore the relationship between the practice of urinary catheterization and total procedure time. Of the 408 patients who underwent TF TAVR, 188 (46.1%) received a peri-procedure indwelling urinary catheter and 220 (53.9%) did not. There was no difference in in-hospital mortality (2.2%), disabling stroke (0.5%), or other major cardiac adverse events. The avoidance of a urinary catheter resulted in significantly lower rates of urinary tract infection requiring a new antibiotic regimen (1.4% versus 6.1%, p = 0.014), haematuria documented by medicine or nursing (3.7% versus 17.6%, p = 0.001), and the need for continuous bladder irrigation (2.7% versus 0%, p = 0.027). The avoidance of a urinary catheter may contribute to improved outcomes in patients undergoing TAVI. The intervention should be further evaluated within the broader study of minimalist TAVI.

Does the disparity in baseline characteristics of patients undergoing transcatheter aortic valve replacement with 23 mm vs. 26 mm valves impact clinical outcome?

PubMed

Escárcega, Ricardo O; Magalhaes, Marco A; Baker, Nevin C; Lipinski, Michael J; Minha, Sa'ar; Torguson, Rebecca; Chen, Fang; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

2016-01-01

We sought to identify if baseline characteristic differences in patients who receive a 23 mm vs. 26 mm valve impact clinical outcomes. Transcatheter aortic valve replacement (TAVR) is currently an approved therapy for patients with severe aortic stenosis who are considered inoperable or are at high risk. We retrospectively examined baseline characteristics and outcomes of patients receiving a 23 mm (n = 132) vs. 26 mm valve (n = 81) via the transfemoral approach. Gender (P < 0.01), previous coronary artery bypass surgery (P < 0.01), history of atrial fibrillation (P = 0.04), and mean Society of Thoracic Surgeons (STS) score (P < 0.01) were significantly different between groups. There were no significant differences in the rates of minor/major vascular complications (2.2 vs. 3.7%, P = 0.68 and 13.0 vs. 12.3%, P = 0.89, respectively). Bleeding complications were also comparable (major bleed 2.3 vs. 1%, P >0.99, minor bleed 19.0 vs. 22.0%, P = 0.67 and life threatening bleed 7.0 vs. 5.0%, P = 0.77). In-hospital death (6.0 vs. 5.0%, P >0.99), 30-day all-cause death (7.6 vs. 6.2%, P = 0.69), and all-cause death at 1 year (17.4 vs. 25.9%, P = 0.13) were also similar between groups. Gender, valve size, previous coronary bypass surgery and atrial fibrillation were not independently associated with mortality; however, on multivariate analysis STS score was (HR 1.11; 95% CI 1.02-1.19; P = 0.01). Patients undergoing TAVR with 23 and 26 mm valves have similar clinical outcomes despite significant differences in baseline characteristics. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

[Wild-type transthyretin-related cardiac amyloidosis and degenerative aortic stenosis: Two inter-related pathologies in the elderly].

PubMed

Calero Núñez, Sofía; Tercero Martínez, Antonia; García López, Juan Carlos; Jiménez-Mazuecos, Jesús

Wild-type transthyretin-related cardiac amyloidosis (ATTRwt) and degenerative aortic stenosis share a common demographic and clinical profile. It was recently suggested that some of the complications arising during and after transcatheter aortic valve replacement (TAVR) could be due to a co-existing cardiac amyloidosis. In a series of autopsies of patients who had undergone TAVR, researchers found ATTR amyloidosis in one third of the cases. A report is presented on two patients with aortic stenosis who were diagnosed with ATTRwt when they were about to undergo a TAVI. ATTRwt is a slowly progressing disease so we need to review the decisions on the therapeutic approach in these patients. Copyright © 2016 SEGG. Publicado por Elsevier España, S.L.U. All rights reserved.

Percutaneous Dual-valve Intervention in a High-risk Patient with Severe Aortic and Mitral Stenosis

PubMed Central

Mrevlje, Blaz; Aboukura, Mohamad; Nienaber, Christoph A.

2016-01-01

Aortic stenosis is the most frequent and mitral stenosis is the least frequent native single-sided valve disease in Europe. Patients with the combination of severe symptomatic degenerative aortic and mitral stenosis are very rare. Guidelines for the treatment of heart valve diseases are clear for single-valve situations. However, there is no common agreement or recommendation for the best treatment strategy in patients with multiple valve disease and severe concomitant comorbidities. A 76-year-old female patient with the combination of severe degenerative symptomatic aortic and mitral stenosis and several comorbidities including severe obesity, who was found unsuitable surgical candidate by the heart team and unsuitable for two-time general anesthesia in the case of two-step single-valve percutaneous approach by anesthesiologists, underwent successful percutaneous dual-valve single-intervention (transcatheter aortic valve implantation and percutaneous mitral balloon commissurotomy). Percutaneous dual-valve single-intervention is feasible in selected symptomatic high-risk patients. PMID:27867460

Influence of the Quantity of Aortic Valve Calcium on the Agreement Between Automated 3-Dimensional Transesophageal Echocardiography and Multidetector Row Computed Tomography for Aortic Annulus Sizing.

PubMed

Podlesnikar, Tomaz; Prihadi, Edgard A; van Rosendael, Philippe J; Vollema, E Mara; van der Kley, Frank; de Weger, Arend; Ajmone Marsan, Nina; Naji, Franjo; Fras, Zlatko; Bax, Jeroen J; Delgado, Victoria

2018-01-01

Accurate aortic annulus sizing is key for selection of appropriate transcatheter aortic valve implantation (TAVI) prosthesis size. The present study compared novel automated 3-dimensional (3D) transesophageal echocardiography (TEE) software and multidetector row computed tomography (MDCT) for aortic annulus sizing and investigated the influence of the quantity of aortic valve calcium (AVC) on the selection of TAVI prosthesis size. A total of 83 patients with severe aortic stenosis undergoing TAVI were evaluated. Maximal and minimal aortic annulus diameter, perimeter, and area were measured. AVC was assessed with computed tomography. The low and high AVC burden groups were defined according to the median AVC score. Overall, 3D TEE measurements slightly underestimated the aortic annulus dimensions as compared with MDCT (mean differences between maximum, minimum diameter, perimeter, and area: -1.7 mm, 0.5 mm, -2.7 mm, and -13 mm 2 , respectively). The agreement between 3D TEE and MDCT on aortic annulus dimensions was superior among patients with low AVC burden (<3,025 arbitrary units) compared with patients with high AVC burden (≥3,025 arbitrary units). The interobserver variability was excellent for both methods. 3D TEE and MDCT led to the same prosthesis size selection in 88%, 95%, and 81% of patients in the total population, the low, and the high AVC burden group, respectively. In conclusion, the novel automated 3D TEE imaging software allows accurate and highly reproducible measurements of the aortic annulus dimensions and shows excellent agreement with MDCT to determine the TAVI prosthesis size, particularly in patients with low AVC burden. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.