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Sample records for jenaclip transcatheter aortic

  1. Transcatheter aortic valve implantation.

    PubMed

    Oliemy, Ahmed; Al-Attar, Nawwar

    2014-01-01

    Transcatheter aortic valve implantation was developed to offer a therapeutic solution to patients with severe symptomatic aortic stenosis who are not candidates for conventional aortic valve replacement. The improvement in transcatheter aortic valve implantation outcomes is still of concern in the areas of stroke, vascular injury, heart block, paravalvular regurgitation and valve durability. Concomitantly, the progress, both technical and in terms of material advances of transcatheter valve systems, as well as in patient selection, renders transcatheter aortic valve implantation an increasingly viable treatment for more and more patients with structural heart disease.

  2. 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 ...

  3. Transcatheter aortic valve implantation in aortic coarctation.

    PubMed

    Schramm, René; Kupatt, Christian; Becker, Christoph; Bombien, René; Reichart, Bruno; Sodian, Ralf; Schmitz, Christoph

    2013-06-01

    A 77-year-old male patient was scheduled for transcatheter aortic valve implantation for symptomatic and severe aortic valve stenosis. Severe multidirectional kinking of the aorta based on aortic coarctation did not allow for the transfemoral, but only for the transapical approach. The procedure was complicated because of the technically challenging retrograde passage of the transfemorally inserted pig-tail catheter required for intraoperative angiography of the aortic root. Correct positioning of the pig-tail catheter into the ascending aorta was accomplished by use of a loop snare, which was advanced into the descending aorta via the antegrade route, passing the cardiac apex, the stenotic aortic valve, and the coarctation-associated kinking. The pig-tail catheter tip was manipulated into the loop snare, pulled traverse the coarctation, and released within the proximal ascending aorta. Subsequent procedures were uneventful and followed the standardized protocol. A 29 mm Edwards Lifescience transcatheter Sapien bioprosthesis was successfully implanted. Georg Thieme Verlag KG Stuttgart · New York.

  4. Minimally Invasive Transcatheter Aortic Valve Replacement (TAVR)

    MedlinePlus Videos and Cool Tools

    Watch a Broward Health surgeon perform a minimally invasive Transcatheter Aortic Valve Replacement (TAVR) Click Here to view the BroadcastMed, Inc. Privacy Policy and Legal Notice © 2017 BroadcastMed, Inc. ...

  5. Echocardiography in Transcatheter Aortic Valve Implantation and Mitral Valve Clip

    PubMed Central

    Luo, Huai

    2012-01-01

    Transcatheter aortic valve implantation and transcatheter mitral valve repair (MitraClip) procedures have been performed worldwide. In this paper, we review the use of two-dimensional and three-dimensional transesophageal echo for guiding transcatheter aortic valve replacement and mitral valve repair. PMID:23019387

  6. Advances in Transcatheter Aortic Valve Replacement

    PubMed Central

    Kleiman, Neal S.; Reardon, Michael J.

    2016-01-01

    Transcatheter aortic valve replacement (TAVR) is becoming widely used for the treatment of symptomatic severe aortic stenosis in patients with high surgical risk. Data from The PARTNER Trial (Placement of AoRtic TraNscathetER Valves) and the Medtronic CoreValve® U.S. Pivotal Investigational Device Exemption trial indicate that survival for extreme-risk patients is superior to best medical therapy and equivalent or superior to surgical aortic valve replacement (SAVR), although long-term durability remains unknown. Paravalvular leak remains higher in TAVR than SAVR, as does permanent pacemaker implantation in self-expanding valves. New-generation valves are addressing these issues, especially for paravalvular leak. There is strong evidence that TAVR is appropriate for both extreme-risk and high-risk patients with symptomatic severe aortic stenosis, and the continued development of new valves are making implantation more reliable. This review discusses the studies supporting the use of TAVR and explores current advances in the field. PMID:27127560

  7. Portico Sheathless Transcatheter Aortic Valve Implantation via Distal Axillary Artery.

    PubMed

    Bruschi, Giuseppe; Colombo, Paola; Botta, Luca; Nava, Stefano; Merlanti, Bruno; Belli, Oriana; Musca, Francesco; Soriano, Francesco; Russo, Claudio F; Oliva, Fabrizio

    2017-02-01

    Transcatheter aortic valve implantation has been designed to treat older patients affected by severe aortic stenosis who are considered high-risk surgical candidates because of multiple comorbidities. The least invasive approach for transcatheter aortic valves implantation should be considered the transfemoral retrograde route, because it is minimally invasive and is feasible with local anesthesia and mild sedation. Despite significant technical improvements in recent years, the transfemoral approach is contraindicated in cases of severe peripheral artery disease. We describe the first case of a Portico transcatheter aortic valve implantation system (St. Jude Medical, Minneapolis, MN) made through the distal axillary artery in a 90-year-old patient affected by severe aortic stenosis.

  8. Vascular approaches for transcatheter aortic valve implantation

    PubMed Central

    Pascual, Isaac; Carro, Amelia; Hernández-Vaquero, Daniel; Díaz, Rocío; Rozado, Jose; Lorca, Rebeca; Martín, María; Silva, Jacobo; Morís, César

    2017-01-01

    Transcatheter aortic valve implantation (TAVI) is a rapidly evolving therapeutic modality currently available for patients with severe aortic stenosis (AS) that are unsuitable for surgery because of technical/anatomical issues or high-estimated surgical risk. Transfemoral approach is the preferred TAVI delivery route when possible. Alternative non-transfemoral access options include transaortic, trans-subclavian and transapical access. Other approaches are also feasible (transcarotid, transcaval, and antegrade aortic) but are restricted to operators and hospitals with experience. The peculiarities of each of the vascular approaches designed for TAVI delivery make it necessary to carefully assess patient’s atherosclerotic load and location, arterial size and tortuosity, and presence of mural thrombus. Several clinical trials are currently ongoing and in the near future the indications for these approaches will likely be better defined and extended to a broader spectrum of TAVI candidates. PMID:28616344

  9. Role of Cardiac CT Before Transcatheter Aortic Valve Implantation (TAVI).

    PubMed

    Marwan, Mohamed; Achenbach, Stephan

    2016-02-01

    Catheter-based aortic valve implantation is increasingly being performed in high-risk patients with symptomatic aortic valve stenosis. For successful planning of the procedure, CT has been shown to provide crucial information concerning the aortic root as well as the peripheral access vessels. This article illustrates the increasing role of CT before transcatheter aortic valve implantation.

  10. Transcatheter aortic valve replacement: techniques, complications, and bailout strategies.

    PubMed

    Singh, Vikas; Macon, Conrad J; Scot Shaw, Eric; Londoño, Juan C; Martinez, Claudia A

    2013-09-01

    Transcatheter aortic valve replacement has emerged as an alternative option for inoperable or very high-risk patients with severe aortic stenosis-however, there are serious complications associated with the procedure, such as patient mortality, stroke, conduction disturbances, paravalvular regurgitation, and vascular concerns. Our review focuses on the most common complications related to transcatheter aortic valve replacement procedures and potential bailout strategies and techniques.

  11. Transcatheter aortic valve implantation: status and challenges.

    PubMed

    Fishbein, Gregory A; Schoen, Frederick J; Fishbein, Michael C

    2014-01-01

    Calcific aortic valve disease of the elderly is the most prevalent hemodynamically-significant valvular disease, and the most common lesion requiring valve replacement in industrialized countries. Transcatheter aortic valve implantation is a less invasive alternative to classical aortic valve replacement that can provide a therapeutic option for high-risk or inoperable patients with aortic stenosis. These devices must be biocompatible, have excellent hemodynamic performance, be easy to insert, be securely anchored without sutures, and be durable, without increased risk of thrombosis or infection. To date, complications are related to the site of entry for insertion, the site of implantation (aorta, coronary ostia, base of left ventricle), and to the structure and design of the inserted device. However, as with any novel technology unanticipated complications will develop. Goals for future development will be to make the devices more effective, more durable, safer, and easier to implant, so as to further improve outcome for patients with severe aortic stenosis. The pathologist participating in research and development, and examination of excised devices will have a critical role in improving outcome for these patients.

  12. Transcatheter Aortic Valve Replacement: Comprehensive Review and Present Status

    PubMed Central

    Misenheimer, Jacob A.; Ramaraj, Radhakrishnan

    2017-01-01

    Aortic stenosis is the most common valvular heart disease in the developed world. About 7% of the population over age 65 years suffers from degenerative aortic stenosis. The prognosis of patients with symptomatic severe aortic stenosis is dismal without valve replacement. Even though the American College of Cardiology recommends aortic valve replacement to treat this condition as a class I recommendation, approximately one third of these patients over the age of 75 years are not referred for surgery. Typically, this is from concern about prohibitive surgical risk associated with patient frailty, comorbidities, age, and severe left ventricular dysfunction. The advent in France of transcatheter aortic valve replacement has raised the hope in the United States for an alternative, less invasive treatment for aortic stenosis. Two recent trials—the Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve (Partner) and the CoreValve US Pivotal—have established transcatheter aortic valve replacement as the preferred approach in patients who are at high or prohibitive surgical risk. The more recently published Partner 2 trial has shown the feasibility of transcatheter aortic valve replacement in intermediate-surgical-risk patients as well. With a profile that promises easier use and better valve performance and delivery, newer-generation valves have shown their potential for further improvement in safety profile and overall outcomes. We review the history and status of this topic. PMID:28265210

  13. [Transcatheter aortic valve implantation (TAVI): Current perspectives].

    PubMed

    Gaede, Luise; Möllmann, Helge

    2015-08-01

    Transcatheter aortic valve implantation (TAVI) has evolved as the treatment modality of choice for elderly patients with symptomatic severe aortic stenosis who are at high risk for surgery. More than 10,000 TAVI procedures were undertaken in Germany during 2014.A mortality benefit has been shown for TAVI compared with conservative treatment in patients deemed inoperable, and the procedure was proven to be at least non-inferior to surgical aortic valve replacement in high-risk patients. Through improvements in preprocedural imaging and in valve technology as well as increasing operator and surgical team experience, TAVI has developed rapidly in the past few years. Complication rates declinded considerably and the latest study results even suggest a superiority of TAVI to surgical valve replacement in patients at intermediate operative risk. Nevertheless, the challenge to avoid procedure-specific complications influencing the outcome still remains. Therefore, making an individual decision about the approach and the valve prosthesis in an interdisciplinary heart team consisting of a cardiologist and a cardiac surgeon is indispensable for guaranteeing the best therapy for the patient.Considering the rapid developments and procedural improvements in this field, randomized trials are required to assess whether the indication for TAVI may be extended to patients at lower perioperative risk in the future.

  14. Prognostic significance of mild aortic regurgitation in predicting mortality after transcatheter aortic valve replacement.

    PubMed

    Jones, Brandon M; Tuzcu, E Murat; Krishnaswamy, Amar; Popovic, Zoran; Mick, Stephanie; Roselli, Eric E; Gul, Sajjad; Devgun, Jasneet; Mistry, Sohi; Jaber, Wael A; Svensson, Lars G; Kapadia, Samir R

    2016-09-01

    Moderate to severe aortic regurgitation after transcatheter aortic valve replacement is associated with worse outcomes. The impact of mild aortic regurgitation has been less clear, possibly because of the broad categories that have been used in clinical trials, but holds increasing importance in the study of next-generation devices in low- and intermediate-risk cohorts. A more granular scheme, which is common in clinical practice and proposed for future trials, may add prognostic value. We evaluated all patients undergoing transfemoral transcatheter aortic valve replacement at the Cleveland Clinic from 2006 to 2012. The degree of aortic regurgitation after transcatheter aortic valve replacement was reported from the echocardiography database based on a clinical, transthoracic echocardiogram performed within 30 days of the procedure. Aortic regurgitation was finely discriminated on the basis of a multiwindow, multiparametric, integrative approach using our usual clinical scale: none, trivial to 1+, 1+, 1 to 2+, 2+, 2 to 3+, 3+, 3 to 4+, or 4+. There were 237 patients included in the analysis. By controlling for age, gender, Society of Thoracic Surgeons score, baseline ejection fraction, and aortic regurgitation before transcatheter aortic valve replacement, there was a significant increase in mortality for each half grade of aortic regurgitation compared with the complete absence of aortic regurgitation after transcatheter aortic valve replacement. The unit hazard ratio for each 1+ increase in aortic regurgitation after transcatheter aortic valve replacement was 2.26 (95% confidence interval, 1.48-3.43; P < .001) considering aortic regurgitation as a continuous variable. Other clinical variables did not significantly affect mortality. Even mild aortic regurgitation after transcatheter aortic valve replacement is associated with worse long-term mortality. There may be prognostic value in reporting milder categories of aortic regurgitation with more granular

  15. [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

    2016-12-09

    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.

  16. Transcatheter aortic valve replacement: design, clinical application, and future challenges.

    PubMed

    Forrest, John K

    2012-06-01

    Transcatheter aortic valve replacement (TAVR) is a new technology that recently has been shown to improve survival and quality of life in patients with severe symptomatic aortic stenosis who are not surgical candidates. The development and design of transcatheter valves has been ongoing for the past 20 years, and TAVR has now been approved by the FDA as a treatment for aortic stenosis in patients who are not surgical candidates. In the United States, there are currently two transcatheter valves available: the Edwards Sapien Valve and the Medtronic CoreValve. While similar in some design elements, they also have characteristic differences that affect both the mechanism of delivery as well as performance in patients. This review aims to take a closer look at the development of this new technology, review the published clinical results, and look toward the future of transcatheter valve therapeutics and the challenges therein.

  17. Coronary Obstruction Following Transcatheter Aortic Valve Implantation

    PubMed Central

    Ribeiro, Henrique Barbosa; Sarmento-Leite, Rogério; Siqueira, Dimytri A. A.; Carvalho, Luiz Antônio; Mangione, José Armando; Rodés-Cabau, Josep; Perin, Marco A.; de Brito, Fábio Sandoli

    2014-01-01

    Background Transcatheter aortic valve implantation (TAVI) was established as an important alternative for high-risk patients with severe aortic stenosis. However, there are few data in the literature regarding coronary obstruction, that although rare, is a potentially fatal complication. Objective Evaluate this complication in Brazil. Methods We evaluated all patients presenting coronary obstruction from the Brazilian Registry of TAVI. Main baseline and procedural characteristics, management of the complication, and clinical outcomes were collected from all patients. Results From 418 consecutive TAVI procedures, coronary obstruction occurred in 3 cases (incidence of 0.72%). All patients were women, without prior coronary artery bypass grafting (CABG), and with mean age of 85 ± 3 years, logistic EuroSCORE of 15 ± 6% and STS-PROM score of 9 ± 4%. All of the cases were performed with balloon-expandable Sapien XT prosthesis. In one patient, with pre-procedural computed tomography data, coronary arteries presented a low height and a narrow sinus of Valsalva. All patients presented with clinically significant severe maintained hypotension, immediately after valve implantation, and even though coronary angioplasty with stent implantation was successfully performed in all cases, patients died during hospitalization, being two periprocedurally. Conclusion Coronary obstruction following TAVI is a rare but potentially fatal complication, being more frequent in women and with the balloon-expandable prosthesis. Anatomical factors might be related with its increased occurrence, highlighting the importance of a good pre-procedural evaluation of the patients in order to avoid this severe complication. PMID:24652089

  18. Coronary obstruction following transcatheter aortic valve implantation.

    PubMed

    Ribeiro, Henrique Barbosa; Sarmento-Leite, Rogério; Siqueira, Dimytri A A; Carvalho, Luiz Antônio; Mangione, José Armando; Rodés-Cabau, Josep; Perin, Marco A; Brito, Fábio Sandoli de

    2014-01-01

    Transcatheter aortic valve implantation (TAVI) was established as an important alternative for high-risk patients with severe aortic stenosis. However, there are few data in the literature regarding coronary obstruction, that although rare, is a potentially fatal complication. Evaluate this complication in Brazil. We evaluated all patients presenting coronary obstruction from the Brazilian Registry of TAVI. Main baseline and procedural characteristics, management of the complication, and clinical outcomes were collected from all patients. From 418 consecutive TAVI procedures, coronary obstruction occurred in 3 cases (incidence of 0.72%). All patients were women, without prior coronary artery bypass grafting (CABG), and with mean age of 85 ± 3 years, logistic EuroSCORE of 15 ± 6% and STS-PROM score of 9 ± 4%. All of the cases were performed with balloon-expandable Sapien XT prosthesis. In one patient, with pre-procedural computed tomography data, coronary arteries presented a low height and a narrow sinus of Valsalva. All patients presented with clinically significant severe maintained hypotension, immediately after valve implantation, and even though coronary angioplasty with stent implantation was successfully performed in all cases, patients died during hospitalization, being two periprocedurally. Coronary obstruction following TAVI is a rare but potentially fatal complication, being more frequent in women and with the balloon-expandable prosthesis. Anatomical factors might be related with its increased occurrence, highlighting the importance of a good pre-procedural evaluation of the patients in order to avoid this severe complication.

  19. Mitral and aortic regurgitation following transcatheter aortic valve replacement

    PubMed Central

    Szymański, Piotr; Hryniewiecki, Tomasz; Dąbrowski, Maciej; Sorysz, Danuta; Kochman, Janusz; Jastrzębski, Jan; Kukulski, Tomasz; Zembala, Marian

    2016-01-01

    Objective To analyse the impact of postprocedural mitral regurgitation (MR), in an interaction with aortic regurgitation (AR), on mortality following transcatheter aortic valve implantation (TAVI). Methods To assess the interaction between MR and AR, we compared the survival rate of patients (i) without both significant MR and AR versus (ii) those with either significant MR or significant AR versus (iii) with significant MR and AR, all postprocedure. 381 participants of the Polish Transcatheter Aortic Valve Implantation Registry (166 males (43.6%) and 215 females (56.4%), age 78.8±7.4 years) were analysed. Follow-up was 94.1±96.5 days. Results Inhospital and midterm mortality were 6.6% and 10.2%, respectively. Significant MR and AR were present in 16% and 8.1% patients, including 3.1% patients with both significant MR and AR. Patients with significant versus insignificant AR differed with respect to mortality (log rank p=0.009). This difference was not apparent in a subgroup of patients without significant MR (log rank p=0.80). In a subgroup of patients without significant AR, there were no significant differences in mortality between individuals with versus without significant MR (log rank p=0.44). Significant MR and AR had a significant impact on mortality only when associated with each other (log rank p<0.0001). At multivariate Cox regression modelling concomitant significant MR and AR were independently associated with mortality (OR 3.2, 95% CI 1.54 to 5.71, p=0.002). Conclusions Significant MR or AR postprocedure, when isolated, had no impact on survival. Combined MR and AR had a significant impact on a patient's prognosis. PMID:26908096

  20. Carotid artery access for transcatheter aortic valve replacement.

    PubMed

    Guyton, Robert A; Block, Peter C; Thourani, Vinod H; Lerakis, Stamatios; Babaliaros, Vasilis

    2013-10-01

    We report three patients who had successful transcatheter aortic valve replacement (TAVR) via carotid artery access. None were candidates for thoracotomy (including minimal access incisions) and had no other vascular access sites that would accommodate the transcatheter valve sheath. Antegrade carotid perfusion and retrograde insertion of the delivery sheath maintained cerebral blood flow without sequelae. Carotid access for TAVR is an option for unusual patients without other access.

  1. [Emergent transcatheter aortic valve implantation in a patient with bicuspid aortic valve stenosis in cardiogenic shock].

    PubMed

    Pizzighini, S; Finet, G; Obadia, J-F; Revel, D; Bresson, D; Rioufol, G

    2015-02-01

    Transcatheter aortic valve implantation is a therapeutic option for high-risk patients with severe aortic valve stenosis and with cardiac symptoms. This procedure requires the preliminary evaluation by a "heart team" and presents some contraindications. We report the case of a 58-year-old man with severe bicuspid aortic valve stenosis and cardiogenic shock. In spite of contraindications and because of the failure of balloon aortic valvuloplasty, transcatheter aortic valve implantation was performed in emergency. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  2. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis.

    PubMed

    Makkar, Raj R; Fontana, Gregory P; Jilaihawi, Hasan; Kapadia, Samir; Pichard, Augusto D; Douglas, Pamela S; Thourani, Vinod H; Babaliaros, Vasilis C; Webb, John G; Herrmann, Howard C; Bavaria, Joseph E; Kodali, Susheel; Brown, David L; Bowers, Bruce; Dewey, Todd M; Svensson, Lars G; Tuzcu, Murat; Moses, Jeffrey W; Williams, Matthew R; Siegel, Robert J; Akin, Jodi J; Anderson, William N; Pocock, Stuart; Smith, Craig R; Leon, Martin B

    2012-05-03

    Transcatheter aortic-valve replacement (TAVR) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The outcomes beyond 1 year in such patients are not known. We randomly assigned patients to transfemoral TAVR or to standard therapy (which often included balloon aortic valvuloplasty). Data on 2-year outcomes were analyzed. A total of 358 patients underwent randomization at 21 centers. The rates of death at 2 years were 43.3% in the TAVR group and 68.0% in the standard-therapy group (P<0.001), and the corresponding rates of cardiac death were 31.0% and 62.4% (P<0.001). The survival advantage associated with TAVR that was seen at 1 year remained significant among patients who survived beyond the first year (hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.92; P=0.02 with the use of the log-rank test). The rate of stroke was higher after TAVR than with standard therapy (13.8% vs. 5.5%, P=0.01), owing, in the first 30 days, to the occurrence of more ischemic events in the TAVR group (6.7% vs. 1.7%, P=0.02) and, beyond 30 days, to the occurrence of more hemorrhagic strokes in the TAVR group (2.2% vs. 0.6%, P=0.16). At 2 years, the rate of rehospitalization was 35.0% in the TAVR group and 72.5% in the standard-therapy group (P<0.001). TAVR, as compared with standard therapy, was also associated with improved functional status (P<0.001). The data suggest that the mortality benefit after TAVR may be limited to patients who do not have extensive coexisting conditions. Echocardiographic analysis showed a sustained increase in aortic-valve area and a decrease in aortic-valve gradient, with no worsening of paravalvular aortic regurgitation. Among appropriately selected patients with severe aortic stenosis who were not suitable candidates for surgery, TAVR reduced the rates of death and hospitalization, with a decrease in symptoms and an improvement in valve hemodynamics that were sustained at 2 years of

  3. Transcatheter aortic valve replacement for bicuspid aortic stenosis 13years post heart transplant.

    PubMed

    Julien, Maureen B; Desai, Nimesh; Brozena, Susan; Herrmann, Howard C

    2016-12-16

    Despite the widespread use of transcatheter aortic valve replacement (TAVR) for moderate and high-risk patients with severe aortic stenosis, it is utilized less frequently in patients with bicuspid aortic valves (BAV). Orthotopic heart transplant (OHT) donors tend to be younger and may have undiagnosed BAV. We present a case of successful TAVR in a patient with BAV thirteen years after OHT.

  4. Midterm outcomes after transcatheter aortic valve implantation.

    PubMed

    Lotfi, Shahram; Dohmen, Guido; Götzenich, Andreas; Haushofer, Marcus; Spillner, Jan Wilhelm; Autschbach, Rüdiger; Hoffmann, Rainer

    2014-01-01

    Transcatheter aortic valve implantation (TAVI) has become a therapeutic option for high-risk or nonoperable patients with severe symptomatic aortic valve stenosis. The best known and most frequently implanted prostheses are the CoreValve and SAPIEN prostheses. We report our experiences and analyze the results of our TAVI program. A total of 357 patients underwent transfemoral (TF) and transapical (TA) TAVI in our center between January 2008 and October 2012. The procedure was performed in 190 patients with CoreValve, in 155 patients with SAPIEN, and in 12 patients with ACURATE TA prostheses. Transfemoral access was used in 190 patients. In 167 patients, TA access was used. The mean age was 80.2 ± 6.4 years. All patients were nonoperable or had a high risk for a conventional aortic valve replacement. The mean logistic EuroSCORE I was 25.92 ± 14.51%. The TF/CoreValve (190 patients) and TA/SAPIEN (155 patients) groups showed significant difference in the patients' mean age (81.7 ± 6.3 years vs. 79.5 ± 6.6 years, P = 0.002) and in mean logistic EuroSCORE I (22.16 ± 13.05% vs. 31.04 ± 16.40, P < 0.001). The overall 30-day mortality (357 patients) was 9.80% (TF, 8.42%; TA, 11.37%); overall 1-year mortality (275 patients), 21.45% (TF, 23.74%; TA, 19.12%); overall 2-year mortality (199 patients), 29.15% (TF, 35.96%; TA, 23.64%); overall 3-year mortality (133 patients), 37.59% (TF, 43.86%; TA, 32.89%); and overall 4-year mortality (38 patients), 39.47% (TF, 45%; TA, 33.33%). The rate of pacemaker implantation after TAVI was significantly higher in the CoreValve group than in the SAPIEN group: 44.74% (85/190 patients) versus 6.45% (10/155 patients), P < 0.001. Stroke rate was higher in the TF-CoreValve group than in the TA-SAPIEN group: 4.21% versus 0.64%, P = 0.045. Outcomes after TAVI were, in our population of nonoperable and high-risk patients, encouraging. The differences in midterm outcomes between the TF-CoreValve TAVI and the TA-SAPIEN TAVI were not significant.

  5. Simultaneous transapical transcatheter aortic valve replacement and transcatheter mitral valve replacement for native valvular stenosis.

    PubMed

    Elkharbotly, Ali; Delago, Augustin; El-Hajjar, Mohammad

    2016-06-01

    Transcatheter aortic valve replacement (TAVR) is well established for patients who cannot undergo surgery (Leon et al., N Engl J Med 2010;363:1597) or are high risk for surgery (Smith et al., N Engl J Med 2011;364:2187-2198). Experience with the TAVR procedure has led to recent reports of successful transcatheter mitral valve replacement (TMVR) procedures (Cheung et al., J Am Coll Cardiol 2014;64:1814; Seiffert et al., J Am Coll Cardiol Interv 2012;5:341-349) separately or simultaneously with the TAVR. However, these reports were of simultaneous valve-in-valve procedures (Cheung Anson, et al. J Am Coll Cardiol 2013;61:1759-1766). A recent report from Portugal also reported simultaneous transpical implantation of an inverted transcatheter aortic valve-in-ring in the mitral position and transcatheter aortic valve (Hasan et al., Circulation 2013;128:e74-e76). There has been an experience of TMVR only in native mitral valve for mitral valve stenosis, but none in both aortic and mitral valves. We report the first in human case of simultaneous transapical TAVR and TMVR in native valves secondary to valvular stenosis. Our patient was not a candidate for percutaneous balloon mitral valvuloplasty secondary to a high Wilkins Score. Sizing of the aortic valve was based on the transesophageal echocardiogram (TEE), whereas sizing of the mitral valve was based on TEE measurements and balloon inflation during left ventriculography. © 2015 Wiley Periodicals, Inc.

  6. Emergency Transcatheter Aortic Valve Implantation for Acute and Early Failure of Sutureless Perceval Aortic Valve.

    PubMed

    Durand, Eric; Tron, Christophe; Eltchaninoff, Hélène

    2015-09-01

    We report the case of a 78-year-old woman admitted for cardiogenic shock related to acute and early failure (severe aortic regurgitation) of a Perceval sutureless aortic bioprosthesis (Sorin Group, Saluggia, Italy). Clinical stability was achieved using rescue transfemoral transcatheter aortic valve-in-valve implantation with an Edwards SAPIEN 3 prosthesis (Edwards Lifesciences, Irvine, CA). To our knowledge, we report herein the first case of successful valve-in-valve implantation using a SAPIEN 3 transcatheter heart valve in a sutureless bioprosthetic aortic valve with acute and early deterioration.

  7. Recently patented transcatheter aortic valves in clinical trials.

    PubMed

    Neragi-Miandoab, Siyamek; Skripochnik, Edvard; Salemi, Arash; Girardi, Leonard

    2013-12-01

    The most widely used heart valve worldwide is the Edwards Sapien, which currently has 60% of the worldwide transcatheter aortic valve implantation (TAVI) market. The CoreValve is next in line in popularity, encompassing 35% of the worldwide TAVI market. Although these two valves dominate the TAVI market, a number of newer transcatheter valves have been introduced and others are in early clinical evaluation. The new valves are designed to reduce catheter delivery diameter, improve ease of positioning and sealing, and facilitate repositioning or removal. The most recent transcatheter valves for transapical use include Acurate TA (Symetis), Engager (Medtronic), and JenaValve the Portico (St Jude), Sadra Lotus Medical (Boston Scientific), and the Direct Flow Medical. These new inventions may introduce more effective treatment options for high-risk patients with severe aortic stenosis. Improvements in transcatheter valves and the developing variability among them may allow for more tailored approaches with respect to patient's anatomy, while giving operators the opportunity to choose devices they feel more comfortable with. Moreover, introducing new devices to the market will create a competitive environment among producers that will reduce high prices and expand availability. The present review article includes a discussion of recent patents related to Transcatheter Aortic Valves.

  8. Autopsy after transcatheter aortic valve implantation.

    PubMed

    van Kesteren, F; Wiegerinck, E M A; Rizzo, S; Baan, J; Planken, R N; von der Thüsen, J H; Niessen, H W M; van Oosterhout, M F M; Pucci, A; Thiene, G; Basso, C; Sheppard, M N; Wassilew, K; van der Wal, A C

    2017-03-01

    Autopsy after transcatheter aortic valve implantation (TAVI) is a new field of interest in cardiovascular pathology. To identify the cause of death, it is important to be familiar with specific findings related to the time interval between the procedure and death. We aimed to provide an overview of the autopsy findings in patients with TAVI in their medical history divided by the timing of death with specific interest in the added value of autopsy over a solely clinically determined cause of death. In 8 European centres, 72 cases with autopsy reports were available. Autopsies were divided according to the time interval of death and reports were analysed. In 32 patients who died ≤72 h postprocedure, mortality resulted from cardiogenic or haemorrhagic shock in 62.5 and 34.4%, respectively. In 31 patients with mortality >72 h to ≤30 days, cardiogenic shock was the cause of death in 51.6% followed by sepsis (22.6%) and respiratory failure (9.7%). Of the nine patients with death >30 days, 88.9% died of sepsis, caused by infective endocarditis in half of them. At total of 12 patients revealed cerebrovascular complications. Autopsy revealed unexpected findings in 61.1% and resulted in a partly or completely different cause of death as was clinically determined. Autopsy on patients who underwent TAVI reveals specific patterns of cardiovascular pathology that clearly relate to the time interval between TAVI and death and significantly adds to the clinical diagnosis. Our data support the role of autopsy including investigation of the cerebrum in the quickly evolving era of cardiac device technology.

  9. The expanding indications of transcatheter aortic valve implantation.

    PubMed

    Chiam, Paul T L; Ewe, See Hooi

    2016-03-01

    Transcatheter aortic valve implantation (TAVI), also known as transcatheter aortic valve replacement, is increasingly performed worldwide and is a technology that is here to stay. It has become the treatment of choice for inoperable patients and an alternative option for patients at high surgical risk with severe aortic stenosis. Early results of TAVI in intermediate-risk patients appear promising although larger randomized trial results are awaited before the widespread adoption of this technology in this big pool of patients. In patients with bicuspid aortic stenosis and degenerated surgical bioprostheses, TAVI has been shown to be feasible and relatively safe, though certain important considerations remain. Indications for TAVI are likely to grow as newer generation and improved devices and delivery systems become available.

  10. Transcatheter Aortic Valve Implantation Experience with SAPIEN 3.

    PubMed

    Ohno, Y; Tamburino, C; Barbanti, M

    2015-06-01

    Based on randomized trials with first generation devices, transcatheter aortic valve replacement (TAVI) has been included into the treatment strategy for high-risk and inoperable patients with severe aortic stenosis. Procedural complications remain a concern with TAVI, including stroke, vascular complications, paravalvular leak (PVL) and conduction disturbances. Addressing these limitations will support TAVI use in lower risk populations. This review discussed features and most recent clinical evidence of the new balloon-expandable THV (SAPIEN 3, Edwards Lifescience, Irvine, CA, USA).

  11. Left ventricular guidewire pacing for transcatheter aortic valve implantation.

    PubMed

    Guérios, Enio E; Wenaweser, Peter; Meier, Bernhard

    2013-12-01

    Previous reports prove the safety and efficacy of cardiac pacing employing a guidewire in the left ventricle as unipolar pacing electrode. We describe the use of left ventricular guidewire pacing as an alternative to conventional transvenous temporary right ventricular pacing in the context of transcatheter aortic valve implantation.

  12. Cerebral events and protection during transcatheter aortic valve replacement.

    PubMed

    Freeman, Melanie; Barbanti, Marco; Wood, David A; Ye, Jian; Webb, John G

    2014-11-15

    Stroke has emerged as one of the most concerning complications following transcatheter aortic valve replacement (TAVR), associated with high morbidity and mortality. We discuss the potential mechanisms of stroke following TAVR, as well as the newly developed embolic protection devices aimed to reduce the risk of stroke.

  13. Valve thrombosis following transcatheter aortic valve implantation: a systematic review.

    PubMed

    Córdoba-Soriano, Juan G; Puri, Rishi; Amat-Santos, Ignacio; Ribeiro, Henrique B; Abdul-Jawad Altisent, Omar; del Trigo, María; Paradis, Jean-Michel; Dumont, Eric; Urena, Marina; Rodés-Cabau, Josep

    2015-03-01

    Despite the rapid global uptake of transcatheter aortic valve implantation, valve trombosis has yet to be systematically evaluated in this field. The aim of this study was to determine the clinical characteristics, diagnostic criteria, and treatment outcomes of patients diagnosed with valve thrombosis following transcatheter aortic valve implantation through a systematic review of published data. Literature published between 2002 and 2012 on valve thrombosis as a complication of transcatheter aortic valve implantation was identified through a systematic electronic search. A total of 11 publications were identified, describing 16 patients (mean age, 80 [5] years, 65% men). All but 1 patient (94%) received a balloon-expandable valve. All patients received dual antiplatelet therapy immediately following the procedure and continued to take either mono- or dual antiplatelet therapy at the time of valve thrombosis diagnosis. Valve thrombosis was diagnosed at a median of 6 months post-procedure, with progressive dyspnea being the most common symptom. A significant increase in transvalvular gradient (from 10 [4] to 40 [12] mmHg) was the most common echocardiographic feature, in addition to leaflet thickening. Thrombus was not directly visualized with echocardiography. Three patients underwent valve explantation, and the remaining received warfarin, which effectively restored the mean transvalvular gradient to baseline within 2 months. Systemic embolism was not a feature of valve thrombosis post-transcatheter aortic valve implantation. Although a rare, yet likely under-reported complication of post-transcatheter aortic valve implantation, progressive dyspnea coupled with an increasing transvalvular gradient on echocardiography within the months following the intervention likely signifies valve thrombosis. While direct thrombus visualization appears difficult, prompt initiation of oral anticoagulation therapy effectively restores baseline valve function. Copyright © 2014

  14. Endovascular Repair for Type A Aortic Dissection After Transcatheter Aortic Valve Replacement With a Medtronic CoreValve.

    PubMed

    Berfield, Kathleen K S; Sweet, Matthew P; McCabe, James M; Reisman, Mark; Mackensen, G Burkhard; Mokadam, Nahush A; Dean, Larry S; Smith, Jason W

    2015-10-01

    Transcatheter aortic valve replacement is being used with increasing frequency in patients with severe aortic stenosis who are otherwise deemed to be at high surgical risk. Aortic dissection is a rare complication of transcatheter aortic valve replacement and poses a unique management dilemma. We describe the treatment of an acute Stanford type A aortic dissection after transcatheter aortic valve replacement with a modified thoracic endovascular stent graft in a 95-year-old woman. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  15. Latest-Generation Transcatheter Aortic Valve Replacement Devices and Procedures.

    PubMed

    Chamandi, Chekrallah; Puri, Rishi; Rodriguez-Gabella, Tania; Rodés-Cabau, Josep

    2017-09-01

    Transcatheter aortic valve replacement (TAVR) is a well-established treatment for patients with severe symptomatic aortic stenosis who are at high or prohibitive surgical risk. More recently, TAVR has emerged as a valid alternative to surgical aortic valve replacement for treating intermediate-risk patients, and several studies are currently evaluating the role of TAVR in low-risk patients. Transcatheter heart valve (THV) technologies have evolved considerably over time, and important iterations have been implemented in many of the latest-generation devices to (1) reduce the size and improve delivery system properties; (2) improve valve deployment, repositioning, and retrievability; and (3) reduce paravalvular leaks. This article reviews the main characteristics of, and clinical results associated with, the newer-generation THVs while providing an overview of novel TAVR indications. Copyright © 2017 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  16. Transcatheter Aortic Valve Implantation in the Elderly: Who to Refer?

    PubMed Central

    Finn, Matthew; Green, Philip

    2015-01-01

    In recent years, experience with transcatheter aortic valve implantation has led to improved outcomes in elderly patients with severe aortic stenosis (AS) who may not have previously been considered for intervention. These patients are often frail with significant comorbid conditions. As the prevalence of AS increases, there is a need for improved assessment parameters to determine the patients most likely to benefit from this novel procedure. This review discusses the diagnostic criteria for severe AS and the trials available to aid in the decision to refer for aortic valve procedures in the elderly. PMID:25216621

  17. Transcatheter Aortic Valve Implantation Despite Challenging Vascular Access

    PubMed Central

    Nascimbene, Angelo; Azpurua, Federico; Livesay, James J.; Fish, R. David

    2015-01-01

    We describe transcatheter aortic valve implantation in a patient who had severe peripheral artery disease. The patient's vascular condition required additional preliminary peripheral intervention to enable adequate vascular access. A 78-year-old man with severe aortic stenosis, substantial comorbidities, and severe heart failure symptoms was referred for aortic valve replacement. The patient's 20-mm aortic annulus necessitated the use of a 23-mm Edwards Sapien valve inserted through a 22F sheath, which itself needed a vessel diameter of at least 7 mm for percutaneous delivery. The left common femoral artery was selected for valve delivery. The left iliac artery and infrarenal aorta underwent extensive intervention to achieve an intraluminal diameter larger than 7 mm. After aortic valvuloplasty, valve deployment was successful, and the transaortic gradient decreased from 40 mmHg to less than 5 mmHg. The patient was discharged from the hospital 4 days postoperatively. We conclude that transcatheter aortic valve implantation can be successfully performed in patients with obstructed vascular access, including stenosis of the infrarenal aorta and the subclavian and coronary arteries. PMID:25873826

  18. Extracorporeal membrane oxygenation in transcatheter aortic valve replacement.

    PubMed

    Dolmatova, Elena; Moazzami, Kasra; Cocke, Thomas P; Elmann, Elie; Vaidya, Pranay; Ng, Arthur F; Satya, Kumar; Narayan, Rajeev L

    2017-01-01

    Background Patients undergoing transcatheter aortic valve replacement can experience severe perioperative complications leading to hemodynamic instability and death. Venoarterial extracorporeal membrane oxygenation can be used to provide cardiorespiratory support during this time. Methods From 2012 to 2015, of 247 patients who underwent transcatheter aortic valve replacement, 6 (2.42%) required extracorporeal membrane oxygenation support. Their mean age was 82 ± 7.4 years, mean Society of Thoracic Surgeons score was 9.4 ± 6.6, and mean aortic gradient was 28.3 ± 12 mm Hg. Rescue extracorporeal membrane oxygenation was required for hemodynamic instability due to ventricular fibrillation ( n = 1), respiratory failure ( n = 1), left ventricular wall rupture ( n = 2), and aortic annulus rupture ( n = 1). In one patient, prophylactic extracorporeal membrane oxygenation was required due to advanced heart failure. Additional procedures included valve-in-valve implantation ( n = 1), conversion to an open procedure ( n = 3), and intraaortic balloon pump insertion ( n = 1). Results The median hospital stay was 20 days. There were 2 hospital deaths in patients whose hospital course was complicated by left ventricular wall rupture or aortic annulus rupture with resulting tamponade. Among the 4 survivors, one required continuous ventilator support following discharge, and 3 experienced no major complications during the first month after discharge. Conclusions Extracorporeal membrane oxygenation can be considered a viable option for high-risk patients undergoing transcatheter aortic valve replacement and those who develop cardiac complications following this procedure and require cardiorespiratory support.

  19. Percutaneous transcatheter aortic valve replacement: first transfemoral implant in Asia.

    PubMed

    Chiam, P T; Koh, T H; Chao, V T; Lee, C Y; See Tho, V Y; Tan, S Y; Lim, S T; Hwang, N C; Sin, Y K; Chua, Y L

    2009-05-01

    Surgical aortic valve replacement (AVR) is the standard of care for patients with symptomatic severe aortic stenosis (AS), providing relief of symptoms and prolonging survival. However, many patients are either denied or not offered surgery due to high surgical risk or non-operability for open AVR. The technology of percutaneous aortic valve implantation emerged in 2002, and has since evolved rapidly with satisfactory results. Currently, almost all the procedures are performed predominantly in Europe and North America. The first-in-Asia percutaneous transcatheter aortic valve implantation via the transfemoral route is described. A 77-year-old man with symptomatic severe AS and at high surgical risk was successfully treated, with sustained clinical improvement and satisfactory haemodynamic results at 30-day follow-up.

  20. Transcatheter aortic valve replacement (TAVR): access planning and strategies.

    PubMed

    Ramlawi, Basel; Anaya-Ayala, Javier E; Reardon, Michael J

    2012-01-01

    Transcatheter aortic valve replacement (TAVR) has proven to be a viable tool for the high-surgical-risk population with severe aortic valve stenosis. Vascular access complications are not uncommon with TAVR and may increase early and late mortality. Avoiding these serious complications is the goal. With experience and careful screening, we are now able to risk-stratify patients who may be at increased risk of vascular complications. While the traditional iliofemoral access site remains the most common for TAVR, alternate access sites that have proven to be viable and safe alternatives include the transapical, direct-aortic, and subclavian techniques. TAVR teams should be familiar and comfortable with these approaches as each of them has its own advantages and weaknesses. The best option is usually one in which the procedure is tailored to the patient. The present review examines our current access planning and strategies for TAVR.

  1. Transcatheter wiring of abdominal aortic aneurysm

    SciTech Connect

    Rossi, P.; Simonetti, G.; Passariello, R.; Stipa, S.; Cavallaro, A.

    1983-04-01

    A new technique of transcatheder wiring of unresectable aortic aneurysm is described that provides simultaneous transcatheder occlusion of both common iliac arteries followed by exillofemoral bypass. The spring coil used for aortic aneurysm wiring was of our own making. The outer portion of a movable core stainless steel guidewire was bent in a coil shape and introduced into the aneurysm through a 7 French Teflon catheder via the right femoral artery. The same catheder was also used for coil embolus occlusion of both iliac arteries.

  2. Durability of prostheses for transcatheter aortic valve implantation.

    PubMed

    Arsalan, Mani; Walther, Thomas

    2016-06-01

    Transcatheter aortic valve implantation (TAVI) has become the standard of care for inoperable patients, and the preferred treatment option for high-risk patients with severe aortic stenosis. Given that this therapy was intended for elderly patients with limited life expectancy, long-term durability has not been in the focus. Now that TAVI is increasingly being used in patients with intermediate-risk and lower-risk profiles, device durability has gained importance. The available mid-term results for TAVI are promising; however, little is known about the fate of TAVI devices beyond 5 years. The experience with long-term durability of surgical valves shows that ≥10-year follow-up is required to ensure reliable durability data. In this Review, we discuss the existing studies of TAVI durability, highlight differences between surgical and transcatheter treatment of aortic stenosis that might influence durability, and present a clinical solution for failed prostheses. Furthermore, we suggest how device durability might influence the future selection of patients for TAVI.

  3. Computed tomography evaluation for transcatheter aortic valve implantation (TAVI): imaging of the aortic root and iliac arteries.

    PubMed

    Schoenhagen, Paul; Kapadia, Samir R; Halliburton, Sandra S; Svensson, Lars G; Tuzcu, E Murat

    2011-01-01

    For patients with severe aortic stenosis, open-heart surgical valve replacement remains the current clinical standard with documented, excellent long-term outcome. Over the past few years, transcatheter aortic valve implantation (TAVI) has developed into a treatment alternative for high-risk patients with severe aortic stenosis. Because transcatheter valvular procedures are characterized by lack of exposure of the operative field, image guidance is critical. This Pictorial Essay describes the role of 3-dimensional imaging with multidetector row computed tomography for detailed reconstructions of the aortic valve, aortic root, and iliac arteries in the context of TAVI.

  4. Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement.

    PubMed

    Webb, John; Rodés-Cabau, Josep; Fremes, Stephen; Pibarot, Philippe; Ruel, Marc; Ibrahim, Reda; Welsh, Robert; Feindel, Christopher; Lichtenstein, Samuel

    2012-01-01

    Patients with severe symptomatic aortic stenosis have a poor prognosis with medical management alone, and balloon aortic valvuloplasty has failed to provide durable clinical benefit. Open surgical replacement of the aortic valve can improve symptoms and survival. Recently, transcatheter aortic valve implantation (TAVI) has been demonstrated to improve survival, quality of life, and functional status in nonoperable patients and to be a viable option for patients in whom the risk of open surgical morbidity or mortality is high. This Canadian Cardiovascular Society position statement represents the consensus of a representative group of cardiologists and cardiac surgeons as to the current, but evolving, role of this less-invasive new therapy. Specific recommendations are provided for selection of patients for TAVI vs surgical aortic valve replacement for native valves and for bioprostheses, approaches to patient evaluation for TAVI, appropriate constitution of multidisciplinary teams involved in performing TAVI, essential facilities that are needed to perform TAVI safely and effectively, and training/qualifications for TAVI operators. Cost considerations, complication rates, and the quality of the available evidence are also discussed. It is hoped that this consensus document will prove to be a useful resource for health professionals, institutions, departments, and decision-making bodies dealing with this important and rapidly evolving therapy.

  5. Percutaneous balloon aortic valvuloplasty in the era of transcatheter aortic valve implantation: a narrative review

    PubMed Central

    Keeble, Thomas R; Khokhar, Arif; Akhtar, Mohammed Majid; Mathur, Anthony; Weerackody, Roshan; Kennon, Simon

    2016-01-01

    The role of percutaneous balloon aortic valvuloplasty (BAV) in the management of severe symptomatic aortic stenosis has come under the spotlight following the development of the transcatheter aortic valve implantation (TAVI) technique. Previous indications for BAV were limited to symptom palliation and as a bridge to definitive therapy for patients undergoing conventional surgical aortic valve replacement (AVR). In the TAVI era, BAV may also be undertaken to assess the ‘therapeutic response’ of a reduction in aortic gradient in borderline patients often with multiple comorbidities, to assess symptomatic improvement prior to consideration of definitive TAVI intervention. This narrative review aims to update the reader on the current indications and practical techniques involved in undertaking a BAV procedure. In addition, a summary of the haemodynamic and clinical outcomes, as well as the frequently encountered procedural complications is presented for BAV procedures conducted during both the pre-TAVI and post-TAVI era. PMID:28008354

  6. Percutaneous balloon aortic valvuloplasty in the era of transcatheter aortic valve implantation: a narrative review.

    PubMed

    Keeble, Thomas R; Khokhar, Arif; Akhtar, Mohammed Majid; Mathur, Anthony; Weerackody, Roshan; Kennon, Simon

    2016-01-01

    The role of percutaneous balloon aortic valvuloplasty (BAV) in the management of severe symptomatic aortic stenosis has come under the spotlight following the development of the transcatheter aortic valve implantation (TAVI) technique. Previous indications for BAV were limited to symptom palliation and as a bridge to definitive therapy for patients undergoing conventional surgical aortic valve replacement (AVR). In the TAVI era, BAV may also be undertaken to assess the 'therapeutic response' of a reduction in aortic gradient in borderline patients often with multiple comorbidities, to assess symptomatic improvement prior to consideration of definitive TAVI intervention. This narrative review aims to update the reader on the current indications and practical techniques involved in undertaking a BAV procedure. In addition, a summary of the haemodynamic and clinical outcomes, as well as the frequently encountered procedural complications is presented for BAV procedures conducted during both the pre-TAVI and post-TAVI era.

  7. The aortic valve: structure, complications and implications for transcatheter aortic valve replacement.

    PubMed

    Rozeik, Mm; Wheatley, Dj; Gourlay, T

    2014-07-01

    The aortic valve operates in a complex haemodynamic environment, opening and closing over 100,000 times a day. When complications arise, such as aortic stenosis, prognosis can be very poor, leading to death within the first few years. Surgical valve replacement is currently the standard treatment for aortic stenosis. A thorough understanding of the anatomy and function of the native valve is imperative when developing a prosthetic replacement that can withstand the complex demands of the heart. This review focuses on the anatomy, structure and disease of the aortic valve and the implications for a transcatheter aortic valve replacement (TAVR). Current complications with TAVR, such as major vascular bleeding, conduction disturbances and patient-prosthesis mismatch (PPM), can be overcome by reducing the delivery profile and through the use of more accurate imaging technologies to work towards a fully functional and durable prosthesis. © The Author(s) 2014.

  8. Platypnea-Orthodeoxia Syndrome after Transcatheter Aortic Valve Implantation

    PubMed Central

    Garot, Jerome; Neylon, Antoinette; Sawaya, Fadi J.; Lefèvre, Thierry

    2016-01-01

    Progressive dyspnea and hypoxaemia in the subacute phase after transcatheter aortic valve implantation (TAVI) are uncommon and warrant immediate assessment of valve and prosthesis leaflet function to exclude thrombosis, as well as investigation for other causes related to the procedure, such as left ventricular dysfunction, pulmonary embolism, and respiratory sepsis. In this case, we report the observation of a patient presenting two weeks after TAVI with arterial hypoxaemia in an upright position, relieved by lying flat, and coupled with an intracardiac shunt detected on echocardiography in the absence of pulmonary hypertension, raising the suspicion of Platypnea-Orthodeoxia Syndrome (POS). Invasive intracardiac haemodynamic assessment showed a significant right-to-left shunt (Qp/Qs = 0.74), which confirmed the diagnosis, with subsequent closure of the intracardiac defect resulting in immediate relief of symptoms and hypoxaemia. To our knowledge, this is the first reported case of an interatrial defect and shunt causing Platypnea-Orthodeoxia Syndrome after transcatheter aortic valve implantation, resolved by percutaneous device closure. PMID:27610250

  9. Quality and Safety in Health Care, Part XXX: Transcatheter Aortic Valve Therapy.

    PubMed

    Harolds, Jay A

    2017-08-12

    Initially, the transcatheter aortic valve replacement procedure was approved only for patients with aortic stenosis that was both severe and symptomatic who either also had too high a risk of aortic valve replacement surgery to have the surgery or who had a high risk for the surgery. Between the years 2012 and 2015, the death rate at 30 days declined from an initial rate of 7.5% to 4.6%. There has also been more use of the transfemoral approach over the years. In 2016, the transcatheter aortic valve replacement was approved for patients with aortic stenosis at intermediate risk of surgery.

  10. Cognitive Outcomes following Transcatheter Aortic Valve Implantation: A Systematic Review

    PubMed Central

    Lai, Ka Sing Paris; Herrmann, Nathan; Saleem, Mahwesh; Lanctôt, Krista L.

    2015-01-01

    Severe aortic stenosis is the most common valvular heart disease in the elderly in the Western world and contributes to a large proportion of all deaths over the age of 70. Severe aortic stenosis is conventionally treated with surgical aortic valve replacement; however, the less invasive transcatheter aortic valve implantation (TAVI) is suggested for those at high surgical risk. While TAVI has been associated with improved survival and favourable outcomes, there is a higher incidence of cerebral microembolisms in TAVI patients. This finding is of concern given mechanistic links with cognitive decline, a symptom highly prevalent in those with cardiovascular disease. This paper reviews the literature assessing the possible link between TAVI and cognitive changes. Studies to date have shown that global cognition improves or remains unchanged over 3 months following TAVI while individual cognitive domains remain preserved over time. However, the association between TAVI and cognition remains unclear due to methodological limitations. Furthermore, while these studies have largely focused on memory, cognitive impairment in this population may be predominantly of vascular origin. Therefore, cognitive assessment focusing on domains important in vascular cognitive impairment, such as executive dysfunction, may be more helpful in elucidating the association between TAVI and cognition in the long term. PMID:25785192

  11. High pacing rates for management of aortic insufficiency after balloon aortic valvuloplasty or transcatheter aortic valve replacement.

    PubMed

    Ali, Omar; Salinger, Michael H; Levisay, Justin P; Feldman, Ted

    2014-01-01

    Aortic insufficiency (AI) after transcatheter aortic valve replacement (TAVR) is difficult to manage when associated with congestive heart failure. AI after balloon aortic valvuloplasty (BAV) may be catastrophic, especially in patients who are not candidates for TAVR. We describe the use of urgent temporary pacing, followed by permanent pacing, to increase the heart rate to diminish diastolic filling time for the short term management of AI after BAV or TAVR. The strategy is particularly useful in patients who already have permanent pacemakers, which are common in this population.

  12. Simulations of Transcatheter Aortic Valve Implantation – Implications for Aortic Root Rupture

    PubMed Central

    Wang, Qian; Kodali, Susheel; Primiano, Charles; Sun, Wei

    2014-01-01

    Objectives Aortic root rupture is one of the most severe complications of transcatheter aortic valve implantation (TAVI). The mechanism of this adverse event remains mostly unknown. The purpose of this study was to obtain a better understanding of the biomechanical interaction between the tissue and stent for patients with a high risk of aortic rupture. Methods We simulated the stent deployment process of three TAVI patients with high aortic rupture risk using finite element method. The first case was a retrospective analysis of an aortic rupture case, while the other two cases were prospective studies, which ended with one cancelled procedure and one successful TAVI. Simulation results were evaluated for the risk of aortic root rupture, as well as coronary artery occlusion, and paravalvular leak. Results For Case 1, the simulated aortic rupture location was the same as clinical observations. From the simulation results, it can be seen that the large calcified spot on the interior of the left coronary sinus between coronary ostium and the aortic annulus was pushed by the stent, causing the aortic rupture. For Case 2 and Case 3, predicated results from the simulations were presented to the clinicians at pre-procedure meetings; and they were in agreement with clinician’s observations and decisions. Conclusions Our results indicated that the engineering analysis could provide additional information to help clinicians evaluate complicated, high risk aortic rupture cases. Since a systematic study of a large patient cohort of aortic rupture is currently not available (due to the low occurrence rate) to clearly understand underlying rupture mechanisms, case by case engineering analysis is recommended for evaluating patient-specific aortic rupture risk. PMID:24736808

  13. Antithrombotic treatment in patients undergoing transcatheter aortic valve implantation (TAVI).

    PubMed

    Nijenhuis, Vincent J; Bennaghmouch, Naoual; van Kuijk, Jan-Peter; Capodanno, Davide; ten Berg, Jurriën M

    2015-04-01

    Transcatheter aortic valve implantation (TAVI) is an established treatment option for symptomatic patients with severe aortic valvular disease who are not suitable for conventional surgical aortic valve replacement. Despite improving experience and techniques, ischaemic and bleeding complications after TAVI remain prevalent and impair survival in this generally old and comorbid-rich population. Due to changing aetiology of complications over time, antiplatelet and anticoagulant therapy after TAVI should be carefully balanced. Empirically, a dual antiplatelet strategy is generally used after TAVI for patients without an indication for oral anticoagulation (OAC; e. g. atrial fibrillation, mechanical mitral valve prosthesis), including aspirin and a thienopyridine. For patients on OAC, a combination of OAC and aspirin or thienopyridine is generally used. This review shows that current registries are unfit to directly compare antithrombotic regimens. Small exploring studies suggest that additional clopidogrel after TAVI only affects bleeding and not ischemic complications. However, these studies are lack in quality in terms of Cochrane criteria. Currently, three randomised controlled trials are recruiting to gather more knowledge about the effects of clopidogrel after TAVI.

  14. Feature identification for image-guided transcatheter aortic valve implantation

    NASA Astrophysics Data System (ADS)

    Lang, Pencilla; Rajchl, Martin; McLeod, A. Jonathan; Chu, Michael W.; Peters, Terry M.

    2012-02-01

    Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to open-heart surgery, and is critically dependent on imaging for accurate placement of the new valve. Augmented image-guidance for TAVI can be provided by registering together intra-operative transesophageal echo (TEE) ultrasound and a model derived from pre-operative CT. Automatic contour delineation on TEE images of the aortic root is required for real-time registration. This study develops an algorithm to automatically extract contours on simultaneous cross-plane short-axis and long-axis (XPlane) TEE views, and register these features to a 3D pre-operative model. A continuous max-flow approach is used to segment the aortic root, followed by analysis of curvature to select appropriate contours for use in registration. Results demonstrate a mean contour boundary distance error of 1.3 and 2.8mm for the short and long-axis views respectively, and a mean target registration error of 5.9mm. Real-time image guidance has the potential to increase accuracy and reduce complications in TAVI.

  15. Cardiac conduction system disease after transcatheter aortic valve replacement.

    PubMed

    Steinberg, Benjamin A; Harrison, J Kevin; Frazier-Mills, Camille; Hughes, G Chad; Piccini, Jonathan P

    2012-11-01

    Transcatheter aortic valve replacement (TAVR) is a rapidly-evolving technology for patients with severe, calcific aortic stenosis. Although these procedures lessen many of the risks and complications of open surgical aortic valve replacement, there remain challenges with TAVR including electrophysiologic complications. Among TAVR prostheses, rates of conduction abnormalities (CAs) vary from less than 10% to more than 50%, with up to one-third of patients requiring placement of a permanent pacemaker following TAVR. Several predictors of CAs have been identified related to device selection, baseline conduction defects, and anatomical considerations. Current data support the hypothesis that CAs result primarily from mechanical compression of the specialized conduction system by the device, although other factors may be involved. Such abnormalities can arise immediately during the procedure or as late as several days after implantation, and can be transient or permanent. Currently, there are no clinical tools to identify patients at highest risk for CAs post-TAVR, or to predict the course of CAs in patients who experience them. Early data suggest outcomes may be worse in high-risk patients, and further studies are needed to identify these patients so as to minimize electrophysiologic complications and determine appropriate monitoring in this expanding population. Copyright © 2012 Mosby, Inc. All rights reserved.

  16. The development of transcatheter aortic valve replacement in the USA.

    PubMed

    Dvir, Danny; Barbash, Israel M; Ben-Dor, Itsik; Okubagzi, Petros; Satler, Lowell F; Waksman, Ron; Pichard, Augusto D

    2012-03-01

    The penetration rate of devices in general, and in transcatheter aortic valve replacement (TAVR) specifically, is significantly delayed in the United States of America (USA) compared with in Europe. This is mostly due to the mission statement of the regulatory agencies in the USA, which requires very rigorous clinical testing of a device prior to its approval. The USA had a major role in the development and evaluation of this technology and USA research has enabled clinicians inside and outside of the USA to conduct a concise scientifically based assessment of the performance of TAVR devices in terms of safety and efficacy. In the following review, we provide data on the development of TAVR in the USA, revealing the critical role the USA has played in this extraordinary process.

  17. Assessing the risk of aortic valve replacement for severe aortic stenosis in the transcatheter valve era.

    PubMed

    Mathew, Verghese; Greason, Kevin L; Suri, Rakesh M; Leon, Martin B; Nkomo, Vuyisile T; Mack, Michael J; Rihal, Charanjit S; Holmes, David R

    2014-10-01

    Surgical aortic valve replacement had been the only definitive treatment of severe aortic stenosis before the availability of transcatheter valve technology. Historically, many patients with severe aortic stenosis had not been offered surgery, largely related to professional and patient perception regarding the risks of operation relative to anticipated benefits. Such patients have been labeled as "high risk" or "inoperable" with respect to their suitability for surgery. The availability of transcatheter aortic valve replacement affords a new treatment option for patients previously not felt to be optimal candidates for surgical valve replacement and allows for the opportunity to reexamine the methods for assessing operative risk in the context of more than 1 available treatment. Standardized risk assessment can be challenging because of both the imprecision of current risk scoring methods and the variability in ascertaining risk related to operator experience as well as local factors and practice patterns at treating facilities. Operative risk in actuality is not an absolute but represents a spectrum from very low to extreme, and the conventional labels of high risk and inoperable are incomplete with respect to their utility in clinical decision making. Moving forward, the emphasis should be on developing an individual assessment that takes into account procedure risk as well as long-term outcomes evaluated in a multidisciplinary fashion, and incorporating patient preferences and goals in a model of shared decision making.

  18. Update: Cardiac Imaging (II). Transcatheter Aortic Valve Replacement: Advantages and Limitations of Different Cardiac Imaging Techniques.

    PubMed

    Podlesnikar, Tomaz; Delgado, Victoria

    2016-03-01

    Transcatheter aortic valve replacement is an established therapy for patients with symptomatic severe aortic stenosis and contraindications or high risk for surgery. Advances in prostheses and delivery system designs and continuous advances in multimodality imaging, particularly the 3-dimensional techniques, have led to improved outcomes with significant reductions in the incidence of frequent complications such as paravalvular aortic regurgitation. In addition, data on prosthesis durability are accumulating. Multimodality imaging plays a central role in the selection of patients who are candidates for transcatheter aortic valve replacement, procedure planning and guidance, and follow-up of prosthesis function. The strengths and limitations of each imaging technique for transcatheter aortic valve replacement will be discussed in this update article. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  19. Management of implant failure during transcatheter aortic valve implantation.

    PubMed

    Ussia, Gian Paolo; Barbanti, Marco; Immè, Sebastiano; Scarabelli, Marilena; Mulè, Massimiliano; Cammalleri, Valeria; Aruta, Patrizia; Pistritto, Anna Maria; Capodanno, Davide; Deste, Wanda; Di Pasqua, Maria Concetta; Tamburino, Corrado

    2010-09-01

    Transcatheter aortic valve implantation (TAVI) is an emerging alternative to palliative medical therapy for nonsurgical patients with severe aortic stenosis. There is a paucity of detailed data on the management and outcome of complications related to the sub-optimal deployment of the prosthesis. We appraised the incidence and management of early implant failure occurring during TAVI. Of 110 patients who underwent TAVI using the third generation 18-French CoreValve ReValving System (Medtronic, MN) in our Institution between June 2007 and January 2010, we identified those experiencing early implant failure and reported on their management and clinical outcome. The primary endpoint was the incidence of major adverse cardiovascular and cerebrovascular event (MACCE) at 30 days and mid-term follow up. Early implant failure occurred in 18 of 110 patients (16.3%). The most common cause was prosthesis under-expansion conditioning moderate to severe peri-valvular leak (44.4%). Prosthesis deployment too low or too high with respect to the aortic annulus leading to severe peri-valvular leak occurred in 22.2% and 5.5% of patients, respectively. Need of valve retrieve after the first attempt of deployment occurred in four cases (22.2%). Prosthesis embolization in the ascending aorta occurred in 5.5% of patients who experienced early implant failure. All implant failure cases were managed percutaneously with gain in aortic valve area from 0.44 ± 0.17 to 1.28 ± 0.27 cm(2) (P < 0.001), decrease of mean transaortic gradient from 55.00 ± 19.51 to 11.58 ± 5.91 mmHg (P < 0.001) and no MACCE at 30 days. After 11 ± 6 months, MACCE occurred cumulatively in two patients (11.1%). Early implant failure can complicate the TAVI procedure with the CoreValve system, but it can be managed safely and effectively with bailout transcatheter techniques, avoiding surgery, with good early and mid-term clinical and echocardiographic results.

  20. A case of SAPIEN XT valve fallen into left ventricle during valve-in-valve transcatheter aortic valve implantation.

    PubMed

    Koizumi, Shigeki; Ehara, Natsuhiko; Nishiya, Kenta; Koyama, Tadaaki

    2017-06-24

    Late transcatheter heart valve embolization is a rare but life-threatening complication of transcatheter aortic valve implantation. Surgical intervention is performed for most cases, but some cases were treated by valve-in-valve transcatheter aortic valve implantation. We describe a patient in whom a 29-mm Edwards SAPIEN XT valve migrated into the left ventricular outflow tract 41 days after the initial implantation. We tried to perform valve-in-valve transcatheter aortic valve implantation using a transfemoral approach. As soon as the second transcatheter heart valve touched the first implanted valve, it fell into the left ventricle. Immediate surgical intervention was required. The first valve was removed, and surgical aortic valve replacement was successfully performed. In conclusion, we should choose surgical aortic valve replacement for late transcatheter heart valve embolization. Even if we need to treat by catheter intervention, transapical approach may be better.

  1. Transcatheter aortic valve implantation with the NVT Allegra transcatheter heart valve system: first-in-human experience with a novel self-expanding transcatheter heart valve.

    PubMed

    Wenaweser, Peter; Stortecky, Stefan; Schütz, Torsten; Praz, Fabien; Gloekler, Steffen; Windecker, Stephan; Elsässer, Albrecht

    2016-05-17

    We aimed to demonstrate the feasibility and investigate the safety of a novel, self-expanding trans-catheter heart valve in a selected patient population with severe aortic stenosis. Between January and September 2013, a total of 21 patients with symptomatic severe aortic stenosis were eligible for transcatheter aortic valve implantation (TAVI) with the self-expanding NVT Allegra bioprosthesis (New Valve Technology, Hechingen, Germany) at two cardiovascular centres. Patients were elderly (age 83.8±4 years), predominantly female (95.2%), and all were considered to be at prohibitive risk for surgical aortic valve replacement (logistic EuroSCORE 30.4±11%). Procedural and device success was achieved in 95.2% and 85.7%, respectively. Echocardiographic assessment at discharge showed favourable haemodynamic results with a reduction of the mean transvalvular aortic gradient from 48.0±21 mmHg to 8.9±3 mmHg. In the majority of patients (90.5%), none or trace aortic regurgitation was recorded. Permanent pacemaker implantation was required in 23.8% of patients within the first 30 days of follow-up. Apart from one procedural death, no other serious adverse events were observed during the periprocedural period. TAVI with the NVT Allegra system was highly effective in alleviating symptoms and reducing NYHA functional class at 30-day follow-up. The first-in-human experience with the NVT Allegra transcatheter heart valve prosthesis was associated with a high rate of procedural success. Furthermore, the NVT Allegra bioprosthesis was able to achieve favourable haemodynamic results and effectively alleviate symptoms at 30-day follow-up. The larger, multicentre NAUTILUS study will provide further information on the safety and efficacy of this novel, second-generation transcatheter aortic bioprosthesis.

  2. Patient-prosthesis mismatch: surgical aortic valve replacement versus transcatheter aortic valve replacement in high risk patients with aortic stenosis

    PubMed Central

    Kron, Irving L.

    2016-01-01

    Patient prosthesis mismatch (PPM) can occur when a prosthetic aortic valve has an effective orifice area (EOA) less than that of a native valve. A recent study by Zorn and colleagues evaluated the incidence and significance of PPM in high risk patients with severe aortic stenosis who were randomized to transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). TAVR is associated with decreased incidence of severe PPM compared to traditional SAVR valves. Severe PPM increases risk for death at 1 year postoperatively in high risk patients. The increased incidence of PPM is largely due to differences in valve design and should encourage development of newer SAVR valves to reduce risk for PPM. In addition more vigorous approaches to root enlargement in small annulus should be performed with SAVR to prevent PPM. PMID:27867654

  3. Patient-prosthesis mismatch: surgical aortic valve replacement versus transcatheter aortic valve replacement in high risk patients with aortic stenosis.

    PubMed

    Ghanta, Ravi K; Kron, Irving L

    2016-10-01

    Patient prosthesis mismatch (PPM) can occur when a prosthetic aortic valve has an effective orifice area (EOA) less than that of a native valve. A recent study by Zorn and colleagues evaluated the incidence and significance of PPM in high risk patients with severe aortic stenosis who were randomized to transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). TAVR is associated with decreased incidence of severe PPM compared to traditional SAVR valves. Severe PPM increases risk for death at 1 year postoperatively in high risk patients. The increased incidence of PPM is largely due to differences in valve design and should encourage development of newer SAVR valves to reduce risk for PPM. In addition more vigorous approaches to root enlargement in small annulus should be performed with SAVR to prevent PPM.

  4. 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.

  5. US-fluoroscopy registration for transcatheter aortic valve implantation.

    PubMed

    Lang, Pencilla; Seslija, Petar; Chu, Michael W A; Bainbridge, Daniel; Guiraudon, Gerard M; Jones, Douglas L; Peters, Terry M

    2012-05-01

    Transcatheter aortic valve implantation is a minimally invasive alternative to open-heart surgery for aortic stenosis in which a stent-based bioprosthetic valve is delivered into the heart on a catheter. Limited visualization during this procedure can lead to severe complications. Improved visualization can be provided by live registration of transesophageal echo (TEE) and fluoroscopy images intraoperatively. Since the TEE probe is always visible in the fluoroscopy image, it is possible to track it using fiducial-based single-perspective pose estimation. In this study, inherent probe tracking performance was assessed, and TEE to fluoroscopy registration accuracy and robustness were evaluated. Results demonstrated probe tracking errors of below 0.6 mm and 0.2°, a 2-D RMS registration error of 1.5 mm, and a tracking failure rate of below 1%. In addition to providing live registration and better accuracy and robustness compared to existing TEE probe tracking methods, this system is designed to be suitable for clinical use. It is fully automatic, requires no additional operating room hardware, does not require intraoperative calibration, maintains existing procedure and imaging workflow without modification, and can be implemented in all cardiac centers at extremely low cost.

  6. Challenges and future opportunities for transcatheter aortic valve therapy.

    PubMed

    Leon, Martin B; Gada, Hemal; Fontana, Gregory P

    2014-01-01

    Transcatheter aortic valve replacement (TAVR) is a novel less-invasive therapy for high-risk patients with severe aortic stenosis (AS). Despite the impressive clinical growth of TAVR, there are many challenges as well as future opportunities. The heart valve team serves as the central vehicle for determining appropriate case selection. Considerations which impact clinical therapy decisions include frailty assessments and defining clinical "futility". There are many controversial procedural issues; choice of vascular access site, valve sizing, adjunctive imaging, and post-dilatation strategies. Complications associated with TAVR (strokes, vascular and bleeding events, para-valvular regurgitation, and conduction abnormalities) must be improved and will require procedural and/or technology enhancements. TAVR site training mandates a rigorous commitment to established society and sponsor guidelines. In the future, TAVR clinical indications should extend to bioprosthetic valve failure, intermediate risk patients, and other clinical scenarios, based upon well conducted clinical trials. New TAVR systems have been developed which should further optimize clinical outcomes, by reducing device profile, providing retrievable features, and preventing para-valvular regurgitation. Other accessory devices, such as cerebral protection to prevent strokes, are also being developed and evaluated in clinical studies. TAVR is a worthwhile addition to the armamentarium of therapies for patients with AS. Current limitations are important to recognize and future opportunities to improve clinical outcomes are being explored. Copyright © 2014 Elsevier Inc. All rights reserved.

  7. 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

  8. Salvage Extracorporeal Membrane Oxygenation Prior to "Bridge" Transcatheter Aortic Valve Replacement.

    PubMed

    Chiu, Peter; Fearon, William F; Raleigh, Lindsay A; Burdon, Grayson; Rao, Vidya; Boyd, Jack H; Yeung, Alan C; Miller, David Craig; Fischbein, Michael P

    2016-06-01

    We describe a patient who presented in profound cardiogenic shock due to bioprosthetic aortic valve stenosis requiring salvage Extracorporeal Membrane Oxygenation followed by a "bridge" valve-in-valve transcatheter aortic valve replacement. doi: 10.1111/jocs.12750 (J Card Surg 2016;31:403-405).

  9. Transcatheter therapy for aortic coarctation with severe systemic hypertension during pregnancy.

    PubMed

    Assaidi, Anass; Sbragia, Pascal; Fraisse, Alain

    2013-10-01

    Aortic coarctation is an unusual cause of hypertension during pregnancy and its management is not clarified. We report transcatheter balloon dilatation and stenting for native aortic coarctation in a 22-year-old pregnant woman with severe and uncontrolled systemic hypertension. Arterial blood pressure could be successfully controlled with medical treatment during the rest of the pregnancy and the patient underwent uneventful delivery. No adverse events or recoarctation was observed during 24 months clinical follow-up. In conclusion, native aortic coarctation can be successfully treated during pregnancy with transcatheter therapy. More experience is needed to confirm the safety and efficacy of such management.

  10. Transcatheter aortic valve replacement in patients with cirrhosis.

    PubMed

    Greason, Kevin L; Mathew, Verghese; Wiesner, Russel H; Suri, Rakesh M; Rihal, Charanjit S

    2013-09-01

    Patients with cirrhosis who undergo cardiac operation with extracorporeal circulation are at high risk for operative morbidity and mortality. Transcatheter aortic valve replacement (TAVR) can obviate the need for cardiopulmonary bypass and may reduce operative morbidity in comparison to standard aortic valve replacement (SAVR) in select patients. Review of 18 patients with aortic valve stenosis and cirrhosis treated with TAVR (n=6) or SAVR (n=12). Patient age was 71 years (58 to 83) and STS Predicted Risk of Mortality was 3.2% (0.7 to 12.3). There were 15 males (83%). Child-Turcotte-Pugh stage was A in 10 patients (56%), B in four (22%), and C in two (11%); the median MELD score was nine (7 to 14). TAVR was successful in all patients without the need for mechanical or cardiopulmonary bypass support. Blood transfusion occurred in four patients (67%) in the TAVR group and in the entire SAVR group. No deaths occurred in the TAVR group, and two (17%) occurred in the SAVR group. Operative complications occurred in two patients (33%) in TAVR group and in eight (67%) in the SAVR group. Hospital stay was five days (3 to 10) in the TAVR group and six (3 to 38) in the SAVR group. All TAVR patients were alive at last follow-up of 219 days (29 to 723), while only five were alive in the SAVR group at 228 days (36 to 719). Our initial experience with TAVR in patients with cirrhosis is encouraging. The technique may be a viable alternative to SAVR in this high-risk subset of patients. © 2013 Wiley Periodicals, Inc.

  11. Long-term Follow-up After Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis.

    PubMed

    Salinas, Pablo; Moreno, Raúl; Calvo, Luis; Sánchez-Recalde, Ángel; Jiménez-Valero, Santiago; Galeote, Guillermo; López-Fernández, Teresa; Ramírez, Ulises; Riera, Luis; Plaza, Ignacio; Moreno, Isidro; Mesa, José María; López-Sendón, José Luis

    2016-01-01

    Transcatheter aortic valve implantation is used as an alternative to surgical valve replacement in patients with severe aortic stenosis who are considered high-surgical-risk or inoperable. Two of the main areas of uncertainty in this field are valve durability and long-term survival. This prospective single-center registry study from a tertiary hospital included all consecutive patients who underwent percutaneous aortic valve implantation between 2008 and 2012. Clinical follow-up lasted a minimum of 2.5 years and a maximum of 6.5 years. Valve Academic Research Consortium-2 definitions were used. Seventy-nine patients were included, with an immediate success rate of 94.9%. The median survival was 47.6 months (95% confidence intervals, 37.4-57.9 months), ie, 4 years. One quarter of deaths occurred in the first month, and most were of cardiovascular cause. After the first month, most deaths were due to noncardiovascular causes. The mean values of valve gradients did not increase during follow-up. The cumulative rate of prosthetic valve dysfunction was 15.3%, with no cases of repeat valve replacement. Half of the patients with aortic stenosis who underwent transcatheter aortic valve implantation were alive 4 years after the procedure. There was a 15.3% prosthetic valve dysfunction rate in cumulative follow-up, with no cases of repeat valve replacement. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  12. Injuries to the Aorta, Aortic Annulus, and Left Ventricle During Transcatheter Aortic Valve Replacement: Management and Outcomes.

    PubMed

    Langer, Nathaniel B; Hamid, Nadira B; Nazif, Tamim M; Khalique, Omar K; Vahl, Torsten P; White, Jonathon; Terre, Juan; Hastings, Ramin; Leung, Diana; Hahn, Rebecca T; Leon, Martin; Kodali, Susheel; George, Isaac

    2017-01-01

    The experience with transcatheter aortic valve replacement is increasing worldwide; however, the incidence of potentially catastrophic cardiac or aortic complications has not decreased. In most cases, significant injuries to the aorta, aortic valve annulus, and left ventricle require open surgical repair. However, the transcatheter aortic valve replacement patient presents a unique challenge as many patients are at high or prohibitive surgical risk and, therefore, an open surgical procedure may not be feasible or appropriate. Consequently, prevention of these potentially catastrophic injuries is vital, and practitioners need to understand when open surgical repair is required and when alternative management strategies can be used. The goal of this article is to provide an overview of current management and prevention strategies for major complications involving the aorta, aortic valve annulus, and left ventricle.

  13. Initial experience of two national centers in transcatheter aortic prosthesis implantation.

    PubMed

    Lluberas, Sebastián; Abizaid, Alexandre; Siqueira, Dimytri; Ramos, Auristela; Costa, J Ribamar; Arrais, Magaly; Kambara, Antônio; Bihan, David Le; Sousa, Amanda; Sousa, J Eduardo

    2014-04-01

    Transcatheter aortic valve implantation is an effective alternative to surgical treatment of severe aortic stenosis in patients who are inoperable or at high surgical risk. To report the immediate and follow-up clinical and echocardiographic results of the initial experience of transcatheter aortic valve implantation. From 2009 June to 2013 February, 112 patients underwent transcatheter aortic valve implantation. Mean age was 82.5 ± 6.5 years, and the logistic EuroSCORE was 23.6 ± 13.5. Procedural success was 84%. After the intervention, a reduction in the mean systolic gradient was observed (pre: 54.7 ± 15.3 vs. post: 11.7 ± 4.0 mmHg; p < 0.01). Cerebrovascular accidents occurred in 3.6%, vascular complications in 19% and permanent pacemaker was required by 13% of the patients. Thirty-day mortality and at follow-up of 16 ± 11 months was 14% and 8.9% respectively. The presence of chronic obstructive pulmonary disease was the only predictor of mortality at 30 days and at follow-up. During follow up, aortic valve area and mean systolic gradient did not change significantly. Transcatheter aortic valve implantation is an effective and safe procedure for the treatment of aortic stenosis in high-surgical risk or inoperable patients. The presence of chronic obstructive pulmonary disease was the only independent predictor of mortality identified both in the first month post-intervention and at follow-up.

  14. Usefulness of Predilation Before Transcatheter Aortic Valve Implantation.

    PubMed

    Pagnesi, Matteo; Jabbour, Richard J; Latib, Azeem; Kawamoto, Hiroyoshi; Tanaka, Akihito; Regazzoli, Damiano; Mangieri, Antonio; Montalto, Claudio; Ancona, Marco B; Giannini, Francesco; Chieffo, Alaide; Montorfano, Matteo; Monaco, Fabrizio; Castiglioni, Alessandro; Alfieri, Ottavio; Colombo, Antonio

    2016-07-01

    Balloon predilation is historically considered a requirement before performing transcatheter aortic valve implantation (TAVI). As the procedure has evolved, it has been questioned whether it is actually needed, but data are lacking on mid-term outcomes. The aim of this study was to evaluate the effect of balloon predilation before TAVI. A total of 517 patients who underwent transfemoral TAVI from November 2007 to October 2015 were analyzed. The devices implanted included the Medtronic CoreValve (n = 216), Medtronic Evolut R (n = 30), Edwards SAPIEN XT (n = 210), and Edwards SAPIEN 3 (n = 61). Patients were divided into 2 groups depending on whether pre-implantation balloon aortic valvuloplasty (pre-BAV) was performed (n = 326) or not (n = 191). Major adverse cardiac and cerebrovascular events (MACCE) were primarily evaluated. Propensity score matching was used to adjust for differences in baseline characteristics and potential confounders (n = 113 pairs). In the overall cohort, patients without pre-BAV had a significantly higher MACCE rate at 30 days, driven by a higher incidence of stroke (0.3% pre-BAV vs 3.7% no-pre-BAV, p <0.01). MACCE and mortality at 1 year were, however, similar in both groups. Independent predictors of MACCE at 1 year included serum creatinine, NYHA class 3 to 4, logistic European System for Cardiac Operative Risk Evaluation, and postdilation. Of note, the postdilation rate was higher in the no-pre-BAV group (21.5% pre-BAV vs 35.6% no-pre-BAV, p <0.001). After propensity score matching, there were no differences in MACCE between the 2 groups. In conclusion, this study showed that, in selected patients and with specific transcatheter valves, TAVI without pre-BAV appears to be associated with similar mid-term outcomes compared with TAVI with pre-BAV, but it may increase the need for postdilation.

  15. Prediction of Poor Outcome After Transcatheter Aortic Valve Replacement.

    PubMed

    Arnold, Suzanne V; Afilalo, Jonathan; Spertus, John A; Tang, Yuanyuan; Baron, Suzanne J; Jones, Philip G; Reardon, Michael J; Yakubov, Steven J; Adams, David H; Cohen, David J

    2016-10-25

    A series of models have been developed to identify patients at high risk for poor outcomes after transcatheter aortic valve replacement (TAVR) to help guide treatment choices, offer patients realistic expectations of long-term outcomes, and support decision making. This study examined the performance of the previously developed TAVR Poor Outcome risk models in an external dataset and explored the incremental contribution of geriatric domains to model performance. Poor outcome after TAVR was defined as death, poor quality of life (QOL), or decline in QOL, as assessed using the Kansas City Cardiomyopathy Questionnaire. We tested 4 TAVR Poor Outcome risk models: 6-month and 1-year full and clinical (reduced) models. We examined each model's discrimination and calibration in the CoreValve trial dataset, and then tested the incremental contribution of frailty and disability markers to the model's discrimination using the incremental discrimination index. Among 2,830 patients who underwent TAVR in the CoreValve US Pivotal Extreme and High Risk trials and associated continued access registries, 31.2% experienced a poor outcome at 6 months following TAVR (death, 17.6%; very poor QOL, 11.6%; QOL decline, 2.0%) and 50.8% experienced a poor outcome at 1 year (death, 30.2%; poor QOL, 19.6%; QOL, decline 1.0%). The models demonstrated similar discrimination as in the Placement of Aortic Transcatheter Valves Trial cohorts (c-indexes, 0.637 to 0.665) and excellent calibration. Adding frailty as a syndrome increased the c-indexes by 0.000 to 0.004 (incremental discrimination index, p < 0.01 for all except the 1-year clinical model), with the most important individual components being disability and unintentional weight loss. Although discrimination of the TAVR Poor Outcome risk models was generally moderate, calibration was excellent among patients with different risk profiles and treated with a different TAVR device. These findings demonstrated the value of these models for

  16. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.

    PubMed

    Leon, Martin B; Smith, Craig R; Mack, Michael; Miller, D Craig; Moses, Jeffrey W; Svensson, Lars G; Tuzcu, E Murat; Webb, John G; Fontana, Gregory P; Makkar, Raj R; Brown, David L; Block, Peter C; Guyton, Robert A; Pichard, Augusto D; Bavaria, Joseph E; Herrmann, Howard C; Douglas, Pamela S; Petersen, John L; Akin, Jodi J; Anderson, William N; Wang, Duolao; Pocock, Stuart

    2010-10-21

    Many patients with severe aortic stenosis and coexisting conditions are not candidates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis. We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause. A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as compared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram. In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause

  17. Aortic valve stenosis after previous coronary bypass: Transcatheter valve implantation or aortic valve replacement?

    PubMed Central

    2012-01-01

    We report a prospective comparison between transcatheter valve implantation (TAVI, n = 13) and surgical aortic valve replacement (AVR, n = 10) in patients with severe aortic valve stenosis and previous coronary bypass surgery (CABG). All patients had at least bilateral patent internal thoracic arteries bypass without indication of repeat revascularization. After a similar post-procedure outcome, despite one early death in TAVI group, the 1-year survival was 100% in surgical group and in transfemoral TAVI group, and 73% in transapical TAVI group. When previous CABG is the lone surgical risk factor, indications for a TAVI procedure have to be cautious, specially if transfemoral approach is not possible. PMID:22642844

  18. Microparticles in patients undergoing transcatheter aortic valve implantation (TAVI).

    PubMed

    Jung, Christian; Lichtenauer, Michael; Figulla, Hans-Reiner; Wernly, Bernhard; Goebel, Bjoern; Foerster, Martin; Edlinger, Christoph; Lauten, Alexander

    2016-08-03

    Degenerative aortic stenosis (AS) is the most frequent form of acquired valvular heart disease. AS is known to entail endothelial dysfunction caused by increased mechanical shear stress leading to elevated circulatory levels of microparticles. Endothelial and platelet microparticles (EMP and PMP) are small vesicles that originate from activated cells and thrombocytes. We sought to evaluate whether transcatheter aortic valve implantation (TAVI) procedure would elicit effects on circulating EMP and PMP. 92 patients undergoing TAVI procedure for severe AS were included in this study. Samples were obtained at each visit before TAVI, 1 week post-procedure and at 1, 3 and after 6 months after TAVI and were evaluated using flow cytometry. A 12 month clinical follow-up was also performed. CD62E+ EMP concentration before TAVI was 21.11 % (±6.6 % SD) and declined to 20.99 % (±6.8 % SD) after 1 week, to 16.63 % (±5.4 % SD, p < 0.0001) after 1 month, to 17.08 % (±4.6 % SD, p < 0.0001) after 3 months and to 15.94 % (±5.4 % SD, p < 0.0001) after 6 months. CD31+/CD42b-, CD31+/Annexin+/- EMP remained unchanged. CD31+/CD41b+ PMP evidenced a slight, but statistically significant increase after TAVI and remained elevated during the entire follow-up. Apart from a procedure-related improvement in echocardiographic parameters, TAVI procedure led also to a decline in CD62E+ EMP. The reduction in pressure gradients with less hemodynamic shear stress seems also to have beneficially affected endothelial homeostasis.

  19. Sedation or general anesthesia for transcatheter aortic valve implantation (TAVI).

    PubMed

    Mayr, N Patrick; Michel, Jonathan; Bleiziffer, Sabine; Tassani, Peter; Martin, Klaus

    2015-09-01

    Transfemoral transcatheter aortic valve implantation (TAVI) is nowadays a routine therapy for elderly patients with severe aortic stenosis (AS) and high perioperative risk. With growing experience, further development of the devices, and the expansion to "intermediate-risk" patients, there is increasing interest in performing this procedure under conscious sedation (TAVI-S) rather than the previously favoured approach of general anesthesia (TAVI-GA). The proposed benefits of TAVI-S include; reduced procedure time, shorter intensive care unit (ICU) length of stay, reduced need for intraprocedural vasopressor support, and the potential to perform the procedure without the direct presence of an anesthetist for cost-saving reasons. To date, no randomized trial data exists. We reviewed 13 non-randomized studies/registries reporting data from 6,718 patients undergoing TAVI (3,227 performed under sedation). Patient selection, study methods, and endpoints have differed considerably between published studies. Reported rates of in-hospital and longer-term mortality are similar for both groups. Up to 17% of patients undergoing TAVI-S require conversion to general anesthesia during the procedure, primarily due to vascular complications, and urgent intubation is frequently associated with hemodynamic instability. Procedure related factors, including hypotension, may compound preexisting age-specific renal impairment and enhance the risk of acute kidney injury. Hypotonia of the hypopharyngeal muscles in elderly patients, intraprocedural hypercarbia, and certain anesthetic drugs, may increase the aspiration risk in sedated patients. General anesthesia and conscious sedation have both been used successfully to treat patients with severe AS undergoing TAVI with similar reported short and long-term mortality outcomes. The authors believe that the significant incidence of complications and unplanned conversion to general anesthesia during TAVI-S mandates the start-to-finish presence

  20. Avoiding the Learning Curve for Transcatheter Aortic Valve Replacement

    PubMed Central

    John, Ranjit; Kelly, Rosemary F.; Helmer, Gregory; Yannopoulos, Demetris; Biring, Timinder; Oestreich, Brett

    2017-01-01

    Objectives. To evaluate whether collaboration between existing and new transcatheter aortic valve replacement (TAVR) programs could help reduce the number of cases needed to achieve optimal efficiency. Background. There is a well-documented learning curve for achieving procedural efficiency and safety in TAVR procedures. Methods. A multidisciplinary collaboration was established between the Minneapolis VA Medical Center (new program) and the University of Minnesota (established program since 2012, n = 219) 1 year prior to launching the new program. Results. 269 patients treated with TAVR (50 treated in the first year at the new program). Mean age was 76 (±18) years and STS score was 6.8 (±6). Access included transfemoral (n = 35, 70%), transapical (n = 8, 16%), transaortic (n = 2, 4%), and subclavian (n = 5, 10%) types. Procedural efficiency (procedural time 158 ± 59 versus 148 ± 62, p = 0.27), device success (96% versus 87%, p = 0.08), length of stay (5 ± 3 versus 6 ± 7 days, p = 0.10), and safety (in hospital mortality 4% versus 6%, p = 0.75) were similar between programs. We found no difference in outcome measures between the first and last 25 patients treated during the first year of the new program. Conclusions. Establishing a partnership with an established program can help mitigate the learning curve associated with these complex procedures. PMID:28246571

  1. [Transcatheter aortic valve implantation.Experience in 26 patients].

    PubMed

    Pineda, Fernando; Sarango, Byron; Sore, Loreto; Deck, Carlos; Turner, Eduardo; Parra, Víctor; Bórquez, Emiliano; Bernal, Sergio; Silva, Jorge; GonzÁlez, Soledad; Uriarte, Polentzi

    2015-12-01

    Aortic valve stenosis (AS) is the most common valvular disease. Its surgical indication is undisputed in symptomatic severe AS, however, 30% of patients are at high surgical risk or inoperable. Transcatheter Valve Implantation (TAVI) is an alternative for this group of patients. To describe the clinical outcomes of TAVI in a group of patients treated at the Instituto Nacional del Tórax, Santiago, Chile. Prospective study including all patients referred for TAVI due to their high surgical risk or being inoperable. All-cause mortality, secondary stroke, permanent pacemaker implantation, vascular complications, prosthetic and periprosthetic regurgitation, Karnosfky test and Functional Capacity (FC) were assessed as endpoints. We evaluated 26 patients with a mean age of 82 years (74% women) in whom 27 procedures were done. The mean Society of Thoracic Surgeons score was 8.8%. Overall mortality at 30 days, one and two years was 11.1, 18.5 and 29.6% respectively. Karnofsky score increased significantly from 62.3% at baseline to 83.9; 88.6 and 88.8% at six months, one and two years, respectively. Prior to the procedure, FC was 3.1 ± 0.6, decreasing significantly to 1.2; 1.3 and 1 at six months, one and two years of follow up. TAVI is an effective alternative treatment for patients with severe symptomatic AS and high surgical risk.

  2. Transcatheter aortic valve repair for management of aortic insufficiency in patients supported with left ventricular assist devices.

    PubMed

    Pal, Jay D; McCabe, James M; Dardas, Todd; Aldea, Gabriel S; Mokadam, Nahush A

    2016-10-01

    The development of new aortic insufficiency after a period of support with a left ventricular assist device can result in progressive heart failure symptoms. Transcatheter aortic valve repair can be an effective treatment in selected patients, but the lack of aortic valve calcification can result in unstable prostheses or paravalvular leak. We describe a technique of deploying a self-expanding CoreValve (Medtronic, Minneapolis, MN, USA) into the aortic annulus, followed by a balloon-expandable SAPIEN-3 (Edwards, Irvine, CA, USA).

  3. Transcatheter aortic valve implantation with Core Valve: First Indian experience of three high surgical risk patients with severe aortic stenosis

    PubMed Central

    Seth, Ashok; Rastogi, Vishal; Kumar, Vijay; Maqbool, Syed; Mustaqueem, Arif; Sekar, V. Ravi

    2013-01-01

    The prevalence of aortic stenosis is increasing with aging population. However with multiple co-morbidities and prior procedures in this aging population, more and more patients are being declared unfit for the ‘Gold Standard’ treatment i.e. surgical aortic valve replacement (AVR). Among the patients who are unfit or high risk for aortic valve replacement (AVR) by open heart surgery, transcatheter aortic valve implantation (TAVI) has been proven to be a valuable alternative improving survival and quality of life. We report first Indian experience of Core Valve (Medtronic Inc.) implantation in three high surgical risk patients performed on 22nd and 23rd February 2012. PMID:23993000

  4. 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.

  5. Automated 3-dimensional aortic annular assessment by multidetector computed tomography in transcatheter aortic valve implantation.

    PubMed

    Watanabe, Yusuke; Morice, Marie-Claude; Bouvier, Erik; Leong, Tora; Hayashida, Kentaro; Lefèvre, Thierry; Hovasse, Thomas; Romano, Mauro; Chevalier, Bernard; Donzeau-Gouge, Patrick; Farge, Arnaud; Cormier, Bertrand; Garot, Philippe

    2013-09-01

    This study sought to evaluate the accuracy, reproducibility, and predictive value for post-procedural aortic regurgitation (AR) of an automated multidetector computed tomography (MDCT) post-processing imaging software, 3mensio Valves (version 5.1.sp1, 3mensio Medical Imaging BV, the Netherlands), in the assessment of patients undergoing transcatheter aortic valve implantation (TAVI). Accurate pre-operative aortic annulus measurements are crucial for patients undergoing TAVI. One hundred five patients undergoing MDCT screening before TAVI were evaluated. Aortic annular measurement was compared between automated 3mensio Valves software and manual data post-processing software on a dedicated workstation; we analyzed the discrimination value of annulus measurement for post-procedural AR in 44 recipients of a self-expanding valve. The automated 3mensio Valves software showed good concordance with manual MDCT measurements as demonstrated by Bland-Altman analysis. The automated software provided equally good reproducibility as manual measurement, especially for measurement of aortic annulus area (intraobserver intraclass correlation coefficients 0.98 vs. 0.97, interobserver 0.98 vs. 0.95). In 44 patients after implantation of a self-expanding valve, the valve diameter/CT-measured geometric mean annulus diameter ratio by automated 3mensio Valves software showed moderate and better discrimination ability in predicting post-procedural AR compared with manual measurement (p = 0.12, area under the curve 0.77, 95% confidence interval: 0.63 to 0.91, area under the curve 0.68, 95% confidence interval: 0.50 to 0.86, respectively). The automated 3mensio Valves software demonstrated reliable, reproducible aortic annulus measurement and better predictive value for post-procedural AR, suggesting important clinical implications for pre-operative assessment of patients undergoing TAVI. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights

  6. Transcatheter versus surgical aortic-valve replacement in high-risk patients.

    PubMed

    Smith, Craig R; Leon, Martin B; Mack, Michael J; Miller, D Craig; Moses, Jeffrey W; Svensson, Lars G; Tuzcu, E Murat; Webb, John G; Fontana, Gregory P; Makkar, Raj R; Williams, Mathew; Dewey, Todd; Kapadia, Samir; Babaliaros, Vasilis; Thourani, Vinod H; Corso, Paul; Pichard, Augusto D; Bavaria, Joseph E; Herrmann, Howard C; Akin, Jodi J; Anderson, William N; Wang, Duolao; Pocock, Stuart J

    2011-06-09

    The use of transcatheter aortic-valve replacement has been shown to reduce mortality among high-risk patients with aortic stenosis who are not candidates for surgical replacement. However, the two procedures have not been compared in a randomized trial involving high-risk patients who are still candidates for surgical replacement. At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement. The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P<0.001); adverse events that were more frequent after surgical replacement included major bleeding (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%, P=0.006). More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days, but by 1 year, there was not a significant between-group difference. In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in

  7. In-Graft Endovascular Stenting Repair for Supravalvular Stenosis From Aortic Rupture After Balloon-Expanding Transcatheter Aortic Valve Implantation.

    PubMed

    Furukawa, Nobuyuki; Scholtz, Werner; Haas, Nikolaus; Ensminger, Stephan; Gummert, Jan; Börgermann, Jochen

    2015-01-01

    An 81-year-old man with high-grade aortic valve stenosis and status post-coronary artery bypass grafting and supracoronary replacement of the ascending aorta was referred for transcatheter aortic valve implantation. He was in New York Heart Association class III and had dyspnea. After appropriate screening, we implanted a 29-mm SAPIEN XT valve (Edwards Lifesciences, Irvine, CA USA) through a transapical approach because of severe peripheral arterial occlusive disease. Postinterventional aortography revealed correct positioning and function of the valve and free coronary ostia but contrast extravasation in the vicinity of the interposed vascular prosthesis, resulting in severe luminal narrowing. We chose to manage the stenosis with an endovascular stent. After stenting, extravascular compression was markedly reduced, and the pressure gradient disappeared. The patient was discharged home on the 20th postoperative day. Three months later, computed tomography depicted correct positioning of both grafts. The patient's general health is good, and he is now in New York Heart Association class II. This case illustrates a complication of transcatheter aortic valve implantation specific for patients with an ascending aortic graft. Although stenting may be a good solution, as depicted by this case, self-expanding transcatheter aortic valves should be preferred in patients with ascending aortic grafts to avoid the described complication.

  8. Rapid-deployment or transcatheter aortic valves in intermediate-risk patients?

    PubMed

    Bruno, Piergiorgio; Di Cesare, Alessandro; Nesta, Marialisa; Cammertoni, Federico; Mazza, Andrea; Paraggio, Lazzaro; Rosenhek, Raphael; Burzotta, Francesco; Crea, Filippo; Trani, Carlo; Massetti, Massimo

    2017-01-01

    Background Transcatheter aortic valve implantation and rapid-deployment aortic valve replacement represent two emerging therapies for patients with intermediate surgical risk and severe aortic stenosis. However, head-to-head comparisons between such novel therapies are lacking. Methods Severe aortic stenosis patients with intermediate surgical risk treated with rapid-deployment valve replacement at our institution were identified and compared with a propensity-matched population of patients who underwent transcatheter aortic valve replacement. Postoperative echocardiographic findings, in-hospital and midterm clinical outcomes were compared. Results We identified 60 patients who received transcatheter ( n = 30) or rapid-deployment ( n = 30) valve replacement. On postoperative echocardiography, freedom from paravalvular regurgitation was higher in the rapid-deployment valve group ( p < 0.001), while postoperative mean transprosthetic gradient was lower in the transcatheter valve group ( p = 0.03). Permanent pacemaker implantation was required more frequently in transcatheter valve patients ( p = 0.01). Postoperative atrial fibrillation was more common in the rapid-deployment valve group ( p = 0.03). Hospital mortality was similarly low in both groups ( p = 0.33). At midterm follow-up, mortality was comparable ( p = 0.42) but the rapid-deployment valve group still had a lower degree of paravalvular regurgitation. Conclusions Transcatheter and rapid-deployment valve replacement are promising treatment options for patients with intermediate surgical risk. These two techniques are associated with specific patterns of prosthesis function and postoperative complications. Further evaluation of the clinical impact of these therapies in this patient population is needed.

  9. Transapical aortic valve and mitral valve in ring prosthesis implantation - a new advance in transcatheter procedures.

    PubMed

    Neves, Paulo C; Paulo, Nelson Santos; Gama, Vasco; Vouga, Luís

    2014-08-01

    Transcatheter valve implantation offers a new treatment modality to those patients whose general condition makes conventional surgery very risky. However, the transcatheter option has only been available for the aortic valve. We describe a case of a successful implantation of two Edwards SAPIEN(®) 26 and 29 mm transapical valves, respectively, in aortic and mitral positions, on a 74-year-old patient with severe aortic and mitral stenosis. The procedure progressed uneventfully. Predischarge echocardiogram showed a peak aortic gradient of 20 mmHg, mild periprosthetic regurgitation, peak and mean mitral gradients of 12 and 4, respectively, and moderate (II/IV) periprosthetic regurgitation. Indications for transapical valve implantation will rapidly increase in the near future. It is essential to individualize the treatment be applied for each patient, in order to optimize the success of the procedure.

  10. Transcatheter aortic valve implantation for paradoxical low-flow low-gradient aortic stenosis patients.

    PubMed

    Debry, Nicolas; Sudre, Arnaud; Amr, Gilles; Delhaye, Cédric; Schurtz, Guillaume; Montaigne, David; Koussa, Mohamad; Modine, Thomas

    2016-03-01

    We compared the outcomes of transcatheter aortic valve implantation (TAVI) in three different aortic stenosis syndromes: paradoxical low-flow low-gradient aortic stenosis (PLFLG), high-gradient aortic stenosis (HGAS), and low ejection fraction low-gradient severe aortic stenosis (LEF-LG). Outcomes for PLFLG patients after TAVI procedure are not well known. Between 2010 and 2013, patients with severe (indexed aortic valve area iAVA≤0.6 cm(2)/m(2)) symptomatic aortic stenosis were consecutively referred to our institution for TAVI because of multiple comorbidities and excessive surgical risk. About 262 patients were split into three groups as following, PLFLG: mean gradient MG≤40 mm Hg, stroke volume index SVI≤35 mL/m(2), ejection fraction EF≥55%, valvuloarterial impedance Zva>4.5 mm Hg/mL/m(2), maximal aortic jet velocity MaxV<4 m/s; MG≤40 mm Hg, MaxV<4 m/s, EF≤50%, SVI≤35 mL/m(2); and HGAS: MaxV>4 m/s, MG>40 mm Hg, EF>55%. The primary endpoint of our study was to evaluate mid-term global and cardiovascular mortalities; secondary endpoints included recommended VARC-2 variables. PLFLG (n = 31) mid-term survival was similar to HGAS (n = 172) (mean follow-up = 13.2 months [4.6-26]). Conversely LEF-LG patients (n = 59) displayed significant higher rates of all-cause (P = 0.01) and cardiovascular mortalities (P = 0.05). Postprocedural outcomes (VARC-2 criteria) were similar in the PLFLG and HGAS groups except regarding major bleeding (P = 0.02), while the LEF-LG group had more congestive heart failure and a higher BNP before discharge (both P < 0.001) than the other groups. 30-days deaths were significantly more frequent in LEF-LG and PLFLG in comparison to HGAS (P = 0.03). As opposed to LEF-LG patients, mid-term prognosis after TAVI procedure in PLFLG patients is similar to HGAS patients despite higher perioperative mortality. © 2015 Wiley Periodicals, Inc.

  11. Caval-Aortic Access to Allow Transcatheter Aortic Valve Replacement in Patients Otherwise Ineligible: Initial Human Experience

    PubMed Central

    Greenbaum, Adam B.; O’Neill, William W.; Paone, Gaetano; Guerrero, Mayra E.; Wyman, Janet F.; Cooper, R. Lebron; Lederman, Robert J.

    2014-01-01

    Objectives We describe the first use of caval-aortic access and closure to enable transcatheter aortic valve replacement (TAVR) in patients who lacked other access options. Caval-aortic access refers to percutaneous entry into the abdominal aorta from the femoral vein through the adjoining inferior vena cava. Background TAVR is attractive in high risk or inoperable patients with severe aortic stenosis. Available transcatheter valves require large introducer sheaths, which risk major vascular complications or preclude TAVR altogether. Caval-aortic access has been successful in animals. Methods We performed a single center retrospective review of procedural and 30-day outcomes of prohibitive-risk patients undergoing TAVR via caval-aortic access. Results Between July 2013 and January 2014, 19 patients underwent TAVR via caval-aortic access. 79% were women. Caval-aortic access and tract closure was successful in all 19; TAVR was successful in 17. Six patients suffered modified VARC-2 major vascular complications, two (11%) of whom required intervention. Most (79%) required blood transfusion. There were no deaths attributable to caval-aortic access. Through 111 (39–229) days of follow up, there were no post-discharge complications related to tract creation or closure. All patients had persistent aorto-caval flow immediately post procedure. Of 16 who underwent repeat imaging after the first week, 15 (94%) had complete closure of the residual aorto-caval tract. Conclusions Percutaneous transcaval venous access to the aorta allows TAVR in otherwise ineligible patients, and may offer a new access strategy for other applications requiring large transcatheter implants. PMID:24814495

  12. Caval-aortic access to allow transcatheter aortic valve replacement in otherwise ineligible patients: initial human experience.

    PubMed

    Greenbaum, Adam B; O'Neill, William W; Paone, Gaetano; Guerrero, Mayra E; Wyman, Janet F; Cooper, R Lebron; Lederman, Robert J

    2014-07-01

    This study describes the first use of caval-aortic access and closure to enable transcatheter aortic valve replacement (TAVR) in patients who lacked other access options. Caval-aortic access refers to percutaneous entry into the abdominal aorta from the femoral vein through the adjoining inferior vena cava. TAVR is attractive in high-risk or inoperable patients with severe aortic stenosis. Available transcatheter valves require large introducer sheaths, which are a risk for major vascular complications or preclude TAVR altogether. Caval-aortic access has been successful in animals. We performed a single-center retrospective review of procedural and 30-day outcomes of prohibitive-risk patients who underwent TAVR via caval-aortic access. Between July 2013 and January 2014, 19 patients underwent TAVR via caval-aortic access; 79% were women. Caval-aortic access and tract closure were successful in all 19 patients; TAVR was successful in 17 patients. Six patients experienced modified VARC-2 major vascular complications, 2 (11%) of whom required intervention. Most (79%) required blood transfusion. There were no deaths attributable to caval-aortic access. Throughout the 111 (range 39 to 229) days of follow up, there were no post-discharge complications related to tract creation or closure. All patients had persistent aorto-caval flow immediately post-procedure. Of the 16 patients who underwent repeat imaging after the first week, 15 (94%) had complete closure of the residual aorto-caval tract. Percutaneous transcaval venous access to the aorta allows TAVR in otherwise ineligible patients, and may offer a new access strategy for other applications requiring large transcatheter implants. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  13. Prosthetic valve endocarditis after transcatheter aortic valve implantation-diagnostic and surgical considerations

    PubMed Central

    Klaaborg, Kaj Erik; Hjortdal, Vibeke; Nørgaard, Bjarne Linde; Terkelsen, Christian Juhl; Jensen, Kaare; Christiansen, Evald Høj; Terp, Kim Allan; Andersen, Gratien; Hvitfeldt, Steen; Andersen, Henning Rud

    2016-01-01

    Prosthetic valve endocarditis (PVE) after transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) is a potential life threatening complication. Better understanding of the incidence, predictors, clinical presentation, diagnostic measures, complications and management of PVE may help improve TAVI long-term outcome. We report a case of TAVI-PVE in an 80-year-old high risk patient in whom SAVR was successfully performed. We have reviewed literature regarding TAVI-PVE. PMID:27867590

  14. 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

  15. 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.

  16. Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis.

    PubMed

    Yoon, Sung-Han; Lefèvre, Thierry; Ahn, Jung-Ming; Perlman, Gidon Y; Dvir, Danny; Latib, Azeem; Barbanti, Marco; Deuschl, Florian; De Backer, Ole; Blanke, Philipp; Modine, Thomas; Pache, Gregor; Neumann, Franz-Josef; Ruile, Philipp; Arai, Takahide; Ohno, Yohei; Kaneko, Hidehiro; Tay, Edgar; Schofer, Niklas; Holy, Erik W; Luk, Ngai H V; Yong, Gerald; Lu, Qingsheng; Kong, William K F; Hon, Jimmy; Kao, Hsien-Li; Lee, Michael; Yin, Wei-Hsian; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Lee, Cheol Whan; Park, Seong-Wook; Kim, Hyo-Soo; Butter, Christian; Khalique, Omar K; Schaefer, Ulrich; Nietlispach, Fabian; Kodali, Susheel K; Leon, Martin B; Ye, Jian; Chevalier, Bernard; Leipsic, Jonathon; Delgado, Victoria; Bax, Jeroen J; Tamburino, Corrado; Colombo, Antonio; Søndergaard, Lars; Webb, John G; Park, Seung-Jung

    2016-09-13

    Few studies have evaluated the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). Particularly, limited data exist comparing the results of TAVR with new-generation devices versus early-generation devices. This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices. The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015. Of 301 patients, 199 patients (71.1%) were treated with early-generation devices (Sapien XT [Edwards Lifesciences Corporation, Irvine, California]: n = 87; CoreValve [Medtronic, Minneapolis, Minnesota]: n = 112) and 102 with new-generation devices (Sapien 3 [Edwards Lifesciences Corporation]: n = 91; Lotus [Boston Scientific Corporation, Marlborough, Massachusetts]: n = 11). The mean Society of Thoracic Surgeons score was 4.7 ± 5.2 without significant differences between groups (4.6 ± 5.1 vs. 4.9 ± 5.4; p = 0.57). Overall, all-cause mortality rates were 4.3% at 30 days and 14.4% at 1 year. Moderate or severe paravalvular leak was absent and significantly less frequent with new-generation compared to early-generation devices (0.0% vs. 8.5%; p = 0.002), which resulted in a higher device success rate (92.2% vs. 80.9%; p = 0.01). There were no differences between early- and new-generation devices in stroke (2.5% vs. 2.0%; p > 0.99), life-threatening bleeding (3.5% vs. 2.9%; p > 0.99), major vascular complication (4.5% vs. 2.9%; p = 0.76), stage 2 to 3 acute kidney injury (2.5% vs. 2.9%; p > 0.99), early safety endpoints (15.1% vs. 10.8%; p = 0.30), and 30-day all-cause mortality (4.5% vs. 3.9%; p > 0.99). The clinical outcomes of TAVR in patients with bicuspid AS were favorable. New-generation devices were associated with less paravalvular leak and, hence, a higher device success rate than early

  17. Learning Alternative Access Approaches for Transcatheter Aortic Valve Replacement: Implications for New Transcatheter Aortic Valve Replacement Centers.

    PubMed

    Henn, Matthew C; Percival, Thomas; Zajarias, Alan; Melby, Spencer J; Lindman, Brian R; Quader, Nishath; Damiano, Ralph J; Moon, Marc R; Lasala, John M; Rao, Ravinder S; Bell, Jennifer; Damiano, Marci S; Maniar, Hersh S

    2017-05-01

    Smaller transcatheter aortic valve replacement (TAVR) delivery systems have increased the number of patients eligible for transfemoral procedures while decreasing the need for transaortic (TAo) or transapical (TA) access. As a result, newer TAVR centers are likely to have less exposure to these alternative access techniques, making it harder to achieve proficiency. The purpose of this study was to evaluate the learning curve for TAVR approaches and compare perioperative outcomes. From January 2008 to December 2014, 400 patients underwent TAVR (transfemoral, n = 179; TA, n = 120; and TAo, n = 101)). Learning curves were constructed using metrics of contrast utilization, procedural, and fluoroscopy times. Outcomes during the learning curve were compared with after proficiency was achieved. Depending on the metric, learning curves for all three routes differed slightly but all demonstrated proficiency by the 50th case. There were no significant differences in procedural times whereas improvements in contrast use were most notable for TA (69 ± 40 mL versus 50 ± 23 mL, p = 0.002). For both TA and TAo, fewer patients received transfusions once proficiency was reached (62% versus 34%, p = 0.003, and 42% versus 14%, p = 0.002, respectively). No differences in 30-day or 1-year mortality were seen before or after proficiency was reached for any approach. The learning curves for TA and TAo are distinct but technical proficiency begins to develop by 25 cases and becomes complete by 50 cases for both approaches. Given the relatively low volume of alternative access, achieving technical proficiency may take significant time. However, technical proficiency had no effect on 30-day or 1-year mortality for any access approach. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  18. Initial Experience of Two National Centers in Transcatheter Aortic Prosthesis Implantation

    PubMed Central

    Lluberas, Sebastián; Abizaid, Alexandre; Siqueira, Dimytri; Ramos, Auristela; Costa, J. Ribamar; Arrais, Magaly; Kambara, Antônio; Bihan, David Le; Sousa, Amanda; Sousa, J. Eduardo

    2014-01-01

    Background Transcatheter aortic valve implantation is an effective alternative to surgical treatment of severe aortic stenosis in patients who are inoperable or at high surgical risk. Objectives To report the immediate and follow-up clinical and echocardiographic results of the initial experience of transcatheter aortic valve implantation. Methods From 2009 June to 2013 February, 112 patients underwent transcatheter aortic valve implantation. Results Mean age was 82.5 ± 6.5 years, and the logistic EuroSCORE was 23.6 ± 13.5. Procedural success was 84%. After the intervention, a reduction in the mean systolic gradient was observed (pre: 54.7 ± 15.3 vs. post: 11.7 ± 4.0 mmHg; p < 0.01). Cerebrovascular accidents occurred in 3.6%, vascular complications in 19% and permanent pacemaker was required by 13% of the patients. Thirty-day mortality and at follow-up of 16 ± 11 months was 14% and 8.9% respectively. The presence of chronic obstructive pulmonary disease was the only predictor of mortality at 30 days and at follow-up. During follow up, aortic valve area and mean systolic gradient did not change significantly. Conclusions Transcatheter aortic valve implantation is an effective and safe procedure for the treatment of aortic stenosis in high-surgical risk or inoperable patients. The presence of chronic obstructive pulmonary disease was the only independent predictor of mortality identified both in the first month post-intervention and at follow-up. PMID:24844875

  19. Changes in cerebral oxygen saturation during transcatheter aortic valve replacement.

    PubMed

    Brodt, Jessica; Vladinov, Greta; Castillo-Pedraza, Catalina; Cooper, Lebron; Maratea, Edward

    2016-10-01

    Cerebral oxygen saturation (rSO2) is a non-invasive monitor used to monitor cerebral oxygen balance and perfusion. Decreases in rSO2 >20 % from baseline have been associated with cerebral ischemia and increased perioperative morbidity. During transcatheter aortic valve replacement (TAVR), hemodynamic manipulation with ventricular pacing up to 180 beats per minute is necessary for valve deployment. The magnitude and duration of rSO2 change during this manipulation is unclear. In this small case series, changes in rSO2 in patients undergoing TAVR are investigated. Ten ASA IV patients undergoing TAVR with general anesthesia at a university hospital were prospectively observed. Cerebral oximetry values were analyzed at four points: pre-procedure (baseline), after tracheal intubation, during valve deployment, and at procedure end. Baseline rSO2 values were 54.5 ± 6.9 %. After induction of general anesthesia, rSO2 increased to a mean of 66.0 ± 6.7 %. During valve deployment, the mean rSO2 decreased <20 % below baseline to 48.5 ± 13.4 %. In two patients, rSO2 decreased >20 % of baseline. Cerebral oxygenation returned to post-induction values in all patients 13 ± 10 min after valve deployment. At procedure end, the mean rSO2 was 67.6 ± 8.1 %. As expected, rapid ventricular pacing resulting in the desired decrease in cardiac output during valve deployment was associated with a significant decrease in rSO2 compared to post-induction values. However, despite increased post-induction values in all patients, whether related to increased inspired oxygen fraction or reduced cerebral oxygen consumption under anesthesia, two patients experienced a significant decrease in rSO2 compared to baseline. Recovery to baseline was not immediate, and took up to 20 min in three patients. Furthermore, baseline rSO2 in this population was at the lower limit of the published normal range. Significant cerebral desaturation during valve deployment may potentially be limited

  20. Alternative transarterial access for CoreValve transcatheter aortic bioprosthesis implantation.

    PubMed

    Bruschi, Giuseppe; De Marco, Federico; Modine, Thomas; Botta, Luca; Colombo, Paola; Mauri, Silvia; Cannata, Aldo; Fratto, Pasquale; Klugmann, Silvio

    2015-05-01

    Transcatheter aortic valve implantation (TAVI) is used to treat elderly patients with severe aortic stenosis who are considered extremely high-risk surgical candidates. The safety and effectiveness of TAVI have been demonstrated in numerous studies. The self-expanding CoreValve bioprosthesis (Medtronic Inc., Minneapolis, MN, USA) was the first transcatheter aortic valve to be granted the Conformité Européene (CE) mark in May 2007 for retrograde transfemoral implantation. However, TAVI patients are also often affected by severe iliofemoral arteriopathy. In these patients, the retrograde transfemoral approach carries a high risk of vascular injury, making this approach unusable. Alternative arterial access sites, such as the subclavian artery, the ascending aorta, and the carotid artery, have been used for retrograde implantation of the CoreValve bioprosthesis. In the present report, we present the procedural considerations, risks, and benefits of the different types of arterial access used to implant the CoreValve bioprosthesis.

  1. 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

    2017-07-06

    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 (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%

  2. 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.

  3. Impact of Ejection Fraction and Aortic Valve Gradient on Outcomes of Transcatheter Aortic Valve Replacement

    PubMed Central

    Baron, Suzanne J.; Arnold, Suzanne V.; Herrmann, Howard C.; Holmes, David; Szeto, Wilson Y.; Allen, Keith B.; Chhatriwalla, Adnan K.; Vemulapali, Sreekaanth; O’Brien, Sean; Dai, Dadi; Cohen, David J.

    2017-01-01

    Background In patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), prior studies have suggested that reduced left ventricular ejection fraction (LVEF) and low aortic valve gradient (AVG) are associated with worse long-term outcomes. Since these conditions commonly coexist, the extent to which they are independently associated with outcomes after TAVR is unknown. Objectives To evaluate the impact of LVEF and AVG on clinical outcomes after TAVR and to determine whether the effect of AVG on outcomes is modified by LVEF. Methods Using data from 11,292 patients who underwent TAVR as part of the TVT Registry, we examined rates of 1-year mortality and recurrent heart failure in patients with varying levels of LV dysfunction (LVEF < 30% vs. 30–50% vs. > 50%) and AVG (< 40mmHg vs. ≥ 40mmHg). Multivariable models were used to estimate the independent effect of AVG and LVEF on outcomes. Results Over the first year of follow-up after TAVR, patients with LV dysfunction and low AVG had higher rates of death and recurrent heart failure. After adjustment for other clinical factors, only low AVG was associated with higher mortality (HR 1.21, 95% CI 1.11–1.32; p < 0.001) and higher rates of heart failure (HR 1.52; 95% CI 1.36–1.69; p < 0.001), whereas the effect of LVEF was no longer significant. There was no evidence of effect modification between AVG and LVEF with respect to either endpoint. Conclusion In this large series of real world patients undergoing TAVR, low AVG, but not LV dysfunction, was associated with higher rates of mortality and recurrent heart failure. Although these findings suggest that AVG should be considered when evaluating the risks and benefits of TAVR for individual patients, neither severe LV dysfunction nor low AVG alone or in combination provide sufficient prognostic discrimination to preclude treatment with TAVR. PMID:27199058

  4. Transcatheter Aortic Valve Replacement Versus Aortic Valve Bypass: A Comparison of Outcomes and Economics.

    PubMed

    Brown, John W; Boyd, Jack H; Patel, Parth M; Baker, Mary L; Syed, Amjad; Ladowski, Joe; Corvera, Joel

    2016-01-01

    Transcatheter aortic valve replacement (TAVR) is currently offered to patients who are high-risk candidates for conventional surgical aortic valve replacement. For the past 37 years, off-pump aortic valve bypass (AVB) has been used in elderly patients at our center for this similarly high-risk group. Although TAVR and AVB were offered to similar patients at our center, comparisons of clinical outcomes and hospital economics for each strategy were not reported. We reviewed the clinical and financial records of 53 consecutive AVB procedures performed since 2008 with the records of 51 consecutive TAVR procedures performed since 2012. Data included demographics, hemodynamics, The Society of Thoracic Surgeons (STS) risk score, extent of coronary disease, and ventricular function. Follow-up was 100% in both groups. Hospital financial information for both cohorts was obtained. Mean risk score for the TAVR group was 10.1% versus 17.6% for AVB group (p < 0.001). Kaplan-Meier hospital rates of 3- and 6-month survival and of 1-year survival were 88%, 86%, 81%, and 61% and 89%, 83%, 83%, and 70% for the TAVR and AVB groups, respectively (p = 0.781). Two patients who had undergone TAVR had a procedure-related stroke. The one stroke in an AVB recipient was late and not procedure related. At discharge, mild and moderate perivalvular and central aortic insufficiency were present in 31% and 16% of TAVR recipients, respectively; no AVB valve leaked. Transvalvular gradients were reduced to less than 10 mm Hg in both groups. The average hospital length of stay for the AVB-treated patients was 13 days, and it was 9 days for the TAVR-treated patients. Median hospital charges were $253,000 for TAVR and $158,000 for AVB. Mean payment to the hospital was $65,000 (TAVR) versus $64,000 (AVB), and the mean positive contribution margin (profit) to the hospital was $14,000 for TAVR versus $29,000 for AVB. TAVR and AVB relieve aortic stenosis and have similar and acceptable procedural mortality

  5. 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

  6. Transcatheter Aortic Valve Implantation (TAVI) for Treatment of Aortic Valve Stenosis

    PubMed Central

    Sehatzadeh, S; Doble, B; Xie, F; Blackhouse, G; Campbell, K; Kaulback, K; Chandra, K; Goeree, R

    2013-01-01

    Background One-year mortality outcomes in the PARTNER trial showed that transcatheter aortic valve implantation (TAVI) was noninferior to surgical aortic valve replacement (sAVR) in patients who were eligible for sAVR (cohort A), and superior to standard treatment in patients who were ineligible for sAVR (cohort B). Objective To update a previous report on the safety, effectiveness, and cost-effectiveness of TAVI, published in 2012. Data Sources A literature search was performed on September 11, 2012, using OVID MEDLINE, OVID MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, EBSCO Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Wiley Cochrane Library, and the Centre for Reviews and Dissemination database, for studies published from January 1, 2011, until September 11, 2012. Review Methods Randomized controlled trials investigating TAVI in comparison to sAVR or standard treatment were included for analysis. Results were summarized descriptively. Results At 2-year follow-up, mortality in cohort A was similar between the TAVI and sAVR groups. Rates of stroke/transient ischemic attack, major vascular complications, and moderate/severe paravalvular aortic regurgitation were significantly higher in the TAVI group, but rate of major bleeding was significantly higher in the sAVR group. Mortality in cohort B was significantly lower with transfemoral (TF) TAVI than with standard treatment, but rate of stroke was significantly higher with TF TAVI. TF TAVI resulted in a more rapid improvement in quality of life scores than sAVR, but this difference was not sustained at 6 and 12 months. Patients who underwent transapical TAVI did not have a greater early improvement in quality of life compared to sAVR patients. Compared to standard treatment, TF TAVI resulted in a greater improvement in quality of life scores at all time points. Incremental cost-effectiveness ratios were in favour of TAVI for inoperable patients in the base-case analysis

  7. Cardiac rehabilitation after transcatheter versus surgical prosthetic valve implantation for aortic stenosis in the elderly.

    PubMed

    Russo, Nicola; Compostella, Leonida; Tarantini, Giuseppe; Setzu, Tiziana; Napodano, Massimo; Bottio, Tomaso; D'Onofrio, Augusto; Isabella, Gianbattista; Gerosa, Gino; Iliceto, Sabino; Bellotto, Fabio

    2014-11-01

    Transcatheter aortic valve implantation plays a leading role in the management of aortic stenosis in patients with comorbidities but no data are available about cardiac rehabilitation in these subjects. This study aimed to compare safety and efficacy of an early, exercise-based, cardiac rehabilitation programme in octogenarians after a traditional surgical aortic valve replacement versus transcatheter aortic valve implantation. Seventy-eight consecutive transcatheter aortic valve implantation patients were studied in order to evaluate the effect of an exercise-based cardiac rehabilitation programme in comparison to 80 of a similar age having surgical aortic valve replacement. Functional capacity was assessed by a 6 min walking test on admission and at the end of the programme. When possible, a cardiopulmonary exercise test was also performed before discharge. The two groups were similar in terms of gender and length of stay in cardiac rehabilitation; as expected, the transcatheter aortic valve implantation group had more comorbidities but no major complications occurred in either group during rehabilitation. All patients enhanced autonomy and mobility and were able to walk at least with the assistance of a stick. In those patients who were able to perform the 6 min walking test, the distance walked at discharge did not significantly differ between the groups (272.7 ± 108 vs. 294.2 ± 101 m, p = 0.42), neither did the exercise capacity assessed by cardiopulmonary exercise test (peak-VO2 12.5 ± 3.6 vs. 13.9 ± 2.7 ml/kg/min, p = 0.16). Cardiac rehabilitation is feasible, safe and effective in octogenarian patients after transcatheter aortic valve implantation as well as after traditional surgery. An early cardiac rehabilitation programme enhances independence, mobility and functional capacity and should be highly encouraged. © The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  8. Patient-Specific Modeling of Biomechanical Interaction in Transcatheter Aortic Valve Deployment

    PubMed Central

    Wang, Qian; Sirois, Eric; Sun, Wei

    2012-01-01

    The objective of this study was to develop a patient-specific computational model to quantify the biomechanical interaction between the transcatheter aortic valve (TAV) stent and the stenotic aortic valve during TAV intervention. Finite element models of a patient-specific stenotic aortic valve were reconstructed from multi-slice computed tomography (MSCT) scans, and TAV stent deployment into the aortic root was simulated. Three initial aortic root geometries of this patient were analyzed: (a) aortic root geometry directly reconstructed from MSCT scans, (b) aortic root geometry at the rapid right ventricle pacing phase, and (c) aortic root geometry with surrounding myocardial tissue. The simulation results demonstrated that stress, strain, and contact forces of the aortic root model directly reconstructed from MSCT scans were significantly lower than those of the model at the rapid ventricular pacing phase. Moreover, the presence of surrounding myocardium slightly increased the mechanical responses. Peak stresses and strains were observed around the calcified regions in the leaflets, suggesting the calcified leaflets helped secure the stent in position. In addition, these elevated stresses induced during TAV stent deployment indicated a possibility of tissue tearing and breakdown of calcium deposits, which might lead to an increased risk of stroke. The potential of paravalvular leak and occlusion of coronary ostia can be evaluated from simulated post-deployment aortic root geometries. The developed computational models could be a valuable tool for pre-operative planning of TAV intervention and facilitate next generation TAV device design. PMID:22698832

  9. Long-term results after transcatheter aortic valve implantation: positive and side effects.

    PubMed

    Godino, C; Pavon, A G; Colombo, A

    2013-08-01

    The scientific and technological progress in the field of medicine has allowed to treat patients with severe aortic valve stenosis and with a high perioperative risk. Before the introduction of transcatheter aortic valve implantation (TAVI), patients considered at high risk for surgical treatment were managed with medical therapy or with balloon aortic valvuloplasty. With more than 50000 transcatheter aortic valves implanted in patients around the world, TAVI has demonstrated to be a valid alternative to surgical aortic valve replacement in inoperable and high-risk patients. The PARTNER trial was the first randomized controlled trial to demonstrate that TAVI is not inferior to SAVR in high-risk patients. However, despite some encouraging short-term results medium and long-term outcomes are not always so encouraging. In this review, we will present the immediate results and distinct TAVI-related drawbacks and relative impact on the long-term outcome. New technology advances promise to simplify TAVI and to improve the results by reducing the rate of TAVI-specific issues such as paravalvular aortic regurgitation, annular rupture, and conduction disturbances which may impact on the clinical outcome. Therefore, we believe that when some of these weaknesses will be overcome, even patients at lower risk might benefit from TAVI in the near future.

  10. [Usefulness of multidetector computed tomography in transcatheter aortic valve implantation. Advantage of a tridimentional imaging modality].

    PubMed

    Escobedo-Uribe, Carlos; Schoenhagen, Paul

    2015-01-01

    Aortic stenosis is the most common valvular disorder in the United States and Europe. Nowadays, surgical aortic valve replacement remains the standard treatment for patients with severe aortic stenosis; however, transcatheter aortic valve implantation represents a less invasive treatment option for aortic stenosis patients considered as high-risk or not suitable for surgical management. Because of the lack of direct visualization of the operative field in transcatheter aortic valve implantation, there is an increased need for precise pre-operative assessment of vascular anatomy. Therefore, in order to improve outcome and avoid complications, multidetector tomography is part of the routine evaluation of patients considered for this treatment. The data obtained covering the aorta and iliac arteries, allows the physician a precise planning prior to the intervention. In this review, we described basic aspects of the procedure, and the clinical relevance of the multidetector tomography. Copyright © 2013 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

  11. Transcatheter aortic-valve replacement with a self-expanding prosthesis.

    PubMed

    Adams, David H; Popma, Jeffrey J; Reardon, Michael J; Yakubov, Steven J; Coselli, Joseph S; Deeb, G Michael; Gleason, Thomas G; Buchbinder, Maurice; Hermiller, James; Kleiman, Neal S; Chetcuti, Stan; Heiser, John; Merhi, William; Zorn, George; Tadros, Peter; Robinson, Newell; Petrossian, George; Hughes, G Chad; Harrison, J Kevin; Conte, John; Maini, Brijeshwar; Mumtaz, Mubashir; Chenoweth, Sharla; Oh, Jae K

    2014-05-08

    We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery. We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing. A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, -0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke. In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement. (Funded by Medtronic; U.S. CoreValve High Risk Study ClinicalTrials.gov number, NCT01240902.).

  12. Timing of Onset and Outcome of New Conduction Abnormalities Following Transcatheter Aortic Valve Implantation: Role of Balloon Aortic Valvuloplasty.

    PubMed

    Campelo-Parada, Francisco; Nombela-Franco, Luis; Urena, Marina; Regueiro, Ander; Jiménez-Quevedo, Pilar; Del Trigo, María; Chamandi, Chekrallah; Rodríguez-Gabella, Tania; Auffret, Vincent; Abdul-Jawad Altisent, Omar; DeLarochellière, Robert; Paradis, Jean-Michel; Dumont, Eric; Philippon, François; Pérez-Castellano, Nicasio; Puri, Rishi; Macaya, Carlos; Rodés-Cabau, Josep

    2017-05-27

    Little is known about the timing of onset and outcome of conduction abnormalities (CA) following balloon-expandable transcatheter aortic valve implantation. The aim of this study was to examine the timing of CA and determine the impact of balloon aortic valvuloplasty (BAV) on the persistence of these abnormalities. A total of 347 patients were included. Of these, 75 had a continuous electrocardiogram recording and a 6-lead electrocardiogram at each step of the procedure. In the transcatheter aortic valve implantation population undergoing continuous electrocardiogram monitoring, new-onset left bundle branch block (LBBB) or third-degree atrioventricular block occurred in 48 (64%) and 16 (21.3%) patients, with 51.5% of CA occurring before valve implantation. Left bundle branch block persisted more frequently at hospital discharge (53.8 vs 22.7%; P=.028) and at 1-month follow-up (38.5 vs 13.6%; P=.054) when occurring before valve implantation. Balloon aortic valvuloplasty prior to valve implantation was used in 264 (76.1%) patients, and 78 (22.5%) had persistent LBBB or complete atrioventricular block requiring pacemaker implantation. Persistent LBBB or unresolved atrioventricular block at 1 month occurred more frequently in the BAV group (76.1 vs 47.6%; P=.021), and the use of BAV was associated with a lack of CA resolution (OR, 3.5; 95%CI, 1.17-10.43; P=.021). In patients undergoing a balloon-expandable transcatheter aortic valve implantation, more than half of CA occurred before valve implantation. Early occurrence of CA was associated with a higher rate of persistence at 1-month follow-up. The use of BAV was associated with an increased risk of CA persistence. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  13. Automatic segmentation of the aortic root in CT angiography of candidate patients for transcatheter aortic valve implantation.

    PubMed

    Elattar, M A; Wiegerinck, E M; Planken, R N; Vanbavel, E; van Assen, H C; Baan, J; Marquering, H A

    2014-07-01

    Transcatheter aortic valve implantation is a minimal-invasive intervention for implanting prosthetic valves in patients with aortic stenosis. Accurate automated sizing for planning and patient selection is expected to reduce adverse effects such as paravalvular leakage and stroke. Segmentation of the aortic root in CTA is pivotal to enable automated sizing and planning. We present a fully automated segmentation algorithm to extract the aortic root from CTA volumes consisting of a number of steps: first, the volume of interest is automatically detected, and the centerline through the ascending aorta and aortic root centerline are determined. Subsequently, high intensities due to calcifications are masked. Next, the aortic root is represented in cylindrical coordinates. Finally, the aortic root is segmented using 3D normalized cuts. The method was validated against manual delineations by calculating Dice coefficients and average distance error in 20 patients. The method successfully segmented the aortic root in all 20 cases. The mean Dice coefficient was 0.95 ± 0.03, and the mean radial absolute error was 0.74 ± 0.39 mm, where the interobserver Dice coefficient was 0.95 ± 0.03 and the mean error was 0.68 ± 0.34 mm. The proposed algorithm showed accurate results compared to manual segmentations.

  14. Valve-in-Valve Transcatheter Valve Implantation in the Non-Aortic Position

    PubMed Central

    Ranney, David N.; Williams, Judson B.; Wang, Andrew; Gaca, Jeffrey G.

    2016-01-01

    Background Transcatheter valve-in-valve (VIV) procedures are an alternative to standard surgical valve replacement in high risk patients. Methods Cases in which a commercially approved transcatheter aortic valve replacement (TAVR) device was used for a non-aortic VIV procedure between November 2013 and September 2015 are reviewed. Clinical, echocardiographic, and procedural details, patient survival, and symptom severity by NYHA class at follow-up were assessed. Results All patients were heart-team determined high-risk for conventional redo surgery (mean STS PROM = 6.8 ± 2.2%). Five patients underwent VIV replacement in the non-aortic position, 4 for bioprosthetic mitral valve dysfunction and one for bioprosthetic tricuspid valve dysfunction. Bioprosthetic failure was due to stenosis in 3 patients and regurgitation in 2 others. A balloon-expandable device was used for all patients (Edwards Lifesciences, Irvine, CA). Transcatheter VIV replacement was accomplished by the transapical (mitral) and transfemoral venous (tricuspid) approaches. Median post-operative length of stay was 5 days (range 3-12). No deaths occurred at a mean follow-up of 21 months. NYHA class at follow-up decreased from class IV at baseline to class I or II for all patients. No paravalvular leaks greater than trivial were encountered. Median mean gradient following mitral replacement was 6.5 mmHg (range 6-13 mmHg), and following tricuspid replacement was 4 mmHg. Post-operative complications included hematuria, epistaxis, acute kidney injury, and atrial fibrillation. Conclusions Transcatheter VIV implantation in the non-aortic position for dysfunctional bioprostheses can be performed safely with favorable clinical outcomes using a balloon expandable TAVR device. PMID:27059552

  15. First case of a left atrial dissection after transcatheter aortic valve replacement.

    PubMed

    Sardar, M Rizwan; Kaddissi, Georges I; Sabir, Sajjad A; Topalian, Simon K

    2016-06-01

    The left atrial dissection is a very infrequently encountered complication after valve replacement and never seen after Transcatheter aortic valve replacement (TAVR). We present an 84-year-old female, who underwent successful transapical TAVR and consequently developed contained left atrial dissection seen on transesophageal echocardiogram. The patient remained stable throughout the procedure and was monitored in critical care unit with conservative management. Although there is low associated intraop mortality, prompt recognition is paramount with follow-up serial imaging.

  16. Correction of aortic regurgitation after transcatheter aortic valve implantation of the Medtronic CoreValveTM prosthesis due to a too-low implantation, using transcatheter repositioning.

    PubMed

    Zahn, Ralf; Schiele, Rudolf; Kilkowski, Caroline; Klein, Bärbel; Zeymer, Uwe; Werling, Christiane; Lehmann, Andreas; Gerckens, Ulrich; Saggau, Werner

    2011-01-01

    Transcatheter aortic valve implantation (TAVI) has been introduced for the treatment of severe symptomatic aortic stenosis in patients not suitable for surgical valve replacement. However, a potential problem of TAVI is the development of severe aortic insufficiency after valve implantation due to a too-low implantation of the valve. Since August 2008, a total of 33 TAVI procedures using the 18 Fr Medtronic CoreValve ReValving system has been performed at the authors' institution. Severe post-implantation aortic regurgitation occurred in three patients (9%), due to a too-low implantation. Two of these patients underwent a catheter-based repositioning of the valve using a standard snare; the third patient declined any further intervention. Both repositioning procedures were uneventful, with no significant residual regurgitation. Severe aortic regurgitation after TAVI with the Medtronic CoreValve system is not uncommon. If the valve is implanted too low, a catheter-based valve repositioning may be the method of choice to resolve the problem.

  17. Direct aortic transcatheter valve implantation via mini-thoracotomy using the Medtronic CoreValve.

    PubMed

    Bruschi, Giuseppe; Botta, Luca; De Marco, Federico; Colombo, Paola; Nonini, Sandra; Klugmann, Silvio; Martinelli, Luigi

    2013-01-01

    Transcatheter aortic valve implantation using the Medtronic CoreValve is a well-established procedure. Although previously carried out only through the common femoral artery, today it is possible to perform the procedure through different arterial alternative access sites. A direct aortic approach through the ascending aorta could be carried out via a right anterior mini-thoracotomy in the second intercostal space. The pericardium is opened to expose the aorta. Two purse-string sutures are then placed on the ascending aorta and a standard retrograde CoreValve implantation is performed with the standard delivery system. Advantages, contraindications, surgical technique and results are discussed.

  18. Patient selection for transcatheter aortic valve implantation: An interventional cardiology perspective.

    PubMed

    Mylotte, Darrren; Martucci, Giuseppe; Piazza, Nicolo

    2012-07-01

    Transcatheter aortic valve implantation (TAVI) has emerged as a highly effective minimally invasive treatment symptomatic for severe calcific aortic stenosis in patients at high or prohibitive surgical risk. The success of TAVI has been determined by a number of factors, but in particular by appropriate patient selection. Appropriate patient selection involves identifying patients with the potential to benefit most from TAVI and individualizing the bioprosthesis type and size, and the vascular access site for each case. We present herein, our critical appraisal on patient selection for TAVI: an interventional cardiology perspective.

  19. Percutaneous paravalvular leak closure after CoreValve transcatheter aortic valve implantation using an arterio-arterial loop

    PubMed Central

    Benito-González, Tomás; Gualis, Javier; Pérez de Prado, Armando; Cuellas, Carlos; Fernandez-Vazquez, Felipe

    2017-01-01

    Significant periprosthetic aortic regurgitation after transcatheter aortic valve implantation has become a major concern of this technique given its association with impaired survival. We report the successful closure of such defect using a vascular occlusion device with the creation of an arterio-arterial loop to gain enough support to advance the delivery sheath into de the left ventricle. PMID:28275491

  20. Embolic capture with updated intra-aortic filter during coronary artery bypass grafting and transaortic transcatheter aortic valve implantation: first-in-human experience.

    PubMed

    Ye, Jian; Webb, John G

    2014-12-01

    We report our first-in-human clinical experience in the use of the new version of the EMBOL-X intra-aortic filter (Edwards Lifesciences Corporation, Irvine, Calif) to capture embolic material during transaortic transcatheter aortic valve implantation and cardiac surgery. Five patients were enrolled into the first-in-human clinical assessment of the new version of the EMBOL-X intra-aortic filter. Three patients underwent coronary artery bypass grafting, and 2 patients underwent transaortic transcatheter aortic valve implantation. During coronary artery bypass grafting, the filter was deployed before clamping of the aorta and removal of the aortic clamp. In contrast, the filter was deployed before aortic puncture for transaortic transcatheter aortic valve implantation and kept in the aorta throughout the entire procedure. The filter introducer sheath and filter were easily placed and removed without difficulty. There were no complications related to the use of the filter. Postoperative examination of the retrieved filters revealed the presence of multiple microemboli in the filters from all 5 cases. Histologic study revealed various kinds of tissue and thrombus. This first-in-human clinical experience has demonstrated the safety and feasibility of using the new version of the EMBOL-X intra-aortic filter during either cardiac surgery or transaortic transcatheter aortic valve implantation. We believe that the combination of the transaortic approach without aortic arch manipulation and the use of the EMBOL-X filter with a high capture rate is a promising strategy to reduce the incidence of embolic complications during transcatheter aortic valve implantation. Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  1. A Review of Most Relevant Complications of Transcatheter Aortic Valve Implantation

    PubMed Central

    Michler, Robert E.

    2013-01-01

    Transcatheter aortic valve implantation (TAVI) has emerged for treating aortic stenosis in patients who are poor candidates for surgical aortic valve replacement. Currently, the balloon-expandable Edwards Sapien valve—which is usually implanted via a transfemoral or transapical approach—and the self-expanding CoreValve ReValving system—which is designed for retrograde application—are the most widely implanted valves worldwide. Although a promising approach for high-risk patients, the indication may be expanded to intermediate- and eventually low-risk patients in the future; however, doing so will require a better understanding of potential complications, risk factors for these complications, and strategies to individualize each patient to a different access route and a specific valve. This paper reviews the most relevant complications that may occur in patients who undergo catheter-based aortic valve implantation. PMID:23844292

  2. Transcatheter aortic valve-in-valve implantation of a CoreValve in a degenerated aortic bioprosthesis.

    PubMed

    Bruschi, Giuseppe; DeMarco, Federico; Oreglia, Jacopo; Colombo, Paola; Fratto, Pasquale; Lullo, Francesca; Paino, Roberto; Martinelli, Luigi; Klugmann, Silvio

    2010-03-01

    In recent years percutaneous aortic valve implantation has emerged as an alternative therapy to treat patients with symptomatic aortic stenosis considered to be high-risk surgical candidates. We report our experience of a percutaneous retrograde CoreValve implantation in a 77-year-old female with aortic bioprosthesis structural degeneration. The patient underwent aortic valve replacement for aortic stenosis in 1999 with the implantation of a 23 mm Carpentier-Edwards; her last echocardiography showed a severe bioprosthesis stenosis. After evaluation by cardiac surgeons and cardiologist, considering the high risk re-do surgical procedure (Logistic Euroscore 30%) and severe comorbidities (severe pulmonary hypertension, hepatocellular carcinoma and severe osteoporosis), a percutaneous aortic valve-in-valve replacement was preferred. A successful percutaneous 26 mm CoreValve prosthesis implantation was performed with the patient awake with local anesthesia and mild sedation. The patient was discharged after 10 days of hospitalization and she is in NYHA functional class I at follow-up. Our experience, characterized by a multidisciplinary approach, necessary to offer the safest conditions and care for patients, demonstrates the feasibility of a new, promising indication for the use of a transcatheter valve implantation: percutaneous treatment of a degenerated aortic bioprosthesis.

  3. Simulation of self expanding transcatheter aortic valve in a realistic aortic root: implications of deployment geometry on leaflet deformation.

    PubMed

    Gunning, Paul S; Vaughan, Ted J; McNamara, Laoise M

    2014-09-01

    Self expanding Transcatheter Aortic Valve Replacements (TAVR) can conform to the geometry of the aortic annulus and the calcified leaflet complex, which may result in leaflet distortion and altered leaflet kinematics, but such changes have not yet been characterized. In this study we developed a computational model to investigate the deployment of a self expanding TAVR in a realistic aortic root model derived from multi-slice computed tomography (MSCT) images. We simulated TAVR crimping/deployment in realistic and idealized aortic root models, followed by diastolic loading of the TAVR leaflets in its final deployed configuration. The TAVR deployed in a realistic aortic root had increased peak loading in the commissural region of the leaflets compared to TAVRs under idealized circular deployment conditions (2.97 vs. 1.52 MPa). Furthermore, orientation of the TAVR in the asymmetric aortic annulus such that the commissures of the TAVR are aligned with the native valve commissures minimized the effect of TAVR stent distortion on peak stresses in the TAVR leaflets (2.97 vs. 2.35 MPa). We propose that preoperative planning of the orientation of the TAVR in the aortic root annulus might minimize the impact of potential stent distortion on leaflet function and may in turn increase long term leaflet durability.

  4. 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

  5. Transcatheter aortic valve replacement through transcaval aortic access in a patient with duplicated inferior vena cava and poor iliofemoral anatomy.

    PubMed

    Fanari, Zaher; Al-Akchar, Mohammad; Mahmaljy, Hadi; Goel, Sachin; Goswami, Nilesh J

    2017-07-01

    Transthoracic (transapical and transaortic) access is inferior compared with femoral artery access. Percutaneous transcaval aortic access is a reasonable alternative approach that is being used in transcatheter aortic valve replacement (TAVR) in patients with poor iliofemoral anatomy. Duplicated Inferior vena cava (DIVC) is an uncommon abnormality. We report the case of 76-year-old lady with history of severe peripheral vascular disease, morbid obesity, diabetes, hypertension, hyperlipidemia and duplicated IVC that had severe symptomatic aortic stenosis. The patient had diffuse bilateral iliac disease precluding the arterial access required for TAVR. Other comorbidities made transthoracic access less desirable. We report the first successful Transcaval TAVR in a patient with DIVC. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. 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.

  7. 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.

  8. How to define a poor outcome after transcatheter aortic valve replacement: conceptual framework and empirical observations from the placement of aortic transcatheter valve (PARTNER) trial.

    PubMed

    Arnold, Suzanne V; Spertus, John A; Lei, Yang; Green, Philip; Kirtane, Ajay J; Kapadia, Samir; Thourani, Vinod H; Herrmann, Howard C; Beohar, Nirat; Zajarias, Alan; Mack, Michael J; Leon, Martin B; Cohen, David J

    2013-09-01

    Transcatheter aortic valve replacement (TAVR) has emerged as a less invasive option for valve replacement of patients with severe aortic stenosis. Although it has been recommended that TAVR should not be offered to patients who will not improve functionally or derive meaningful survival benefit from the procedure, no guidance exists on how best to identify such patients. The first step in this process is to define a poor outcome that can then be used as a foundation for subsequent case identification. We sought to evaluate potential definitions of a poor outcome after TAVR that combine both mortality and quality of life components. Using data from 463 patients who underwent TAVR as part of the Placement of AoRTic TraNscathetER Valve (PARTNER) trial, we evaluated 6-month mortality and quality of life outcomes using the Kansas City Cardiomyopathy Questionnaire to explore potential definitions of a poor outcome. We then compared the strengths and weaknesses of each potential definition by examining the relationship between baseline and 6-month Kansas City Cardiomyopathy Questionnaire scores for each patient. Based on these analyses, we argue that the most appropriate definition of a poor outcome after TAVR is (1) death, (2) Kansas City Cardiomyopathy Questionnaire overall summary score <45, or (3) Kansas City Cardiomyopathy Questionnaire decrease of ≥10 points, which best reflects a failure to achieve the therapeutic goals of TAVR. Using empirical data on a large number of patients enrolled in the PARTNER trial, we propose a definition for poor outcome after TAVR that combines both mortality and quality of life measures into a single composite end point. Use of this end point (or other similar end points) in future studies can facilitate development of predictive models that may be useful to identify patients who are poor candidates for TAVR and to provide such patients and their families with appropriate expectations of functional recovery after TAVR.

  9. Aortic annulus dimension assessment by computed tomography for transcatheter aortic valve implantation: differences between systole and diastole.

    PubMed

    Bertaso, Angela G; Wong, Dennis T L; Liew, Gary Y H; Cunnington, Michael S; Richardson, James D; Thomson, Viji S; Lorraine, Brett; Kourlis, George; Leech, Diana; Worthley, Matthew I; Worthley, Stephen G

    2012-12-01

    Accurate assessment of aortic annular dimensions is essential for successful transcatheter aortic valve implantation (TAVI). Annular dimensions are conventionally measured in mid-systole by multidetector computed tomography (MDCT), echocardiography and angiography. Significant differences in systolic and diastolic aortic annular dimensions have been demonstrated in cohorts without aortic stenosis (AS), but it is unknown whether similar dynamic variation in annular dimensions exists in patients with severe calcific AS in whom aortic compliance is likely to be substantially reduced. We investigated the variation in aortic annular dimensions between systole and diastole in patients with severe calcific AS. Patients with severe calcific AS referred for TAVI were evaluated by 128-slice MDCT. Aortic annular diameter was measured during diastole and systole in the modified coronal, modified sagittal, and basal ring planes (maximal, minimal and mean diameters). Differences between systole and diastole were analysed by paired t test. Fifty-nine patients were included in the analysis. Three of the five aortic dimensions measured increased significantly during systole. The largest change was a 0.75 mm (3.4%) mean increase in the minimal diameter of the basal ring during systole (p = 0.004). This corresponds closely to the modified sagittal view, which also increased by mean 0.42 mm (1.9%) during systole (p = 0.008). There was no significant change in the maximal diameter of the basal ring or the modified coronal view during systole (p > 0.05). There is a small magnitude but statistically significant difference in aortic annulus dimensions of patients with severe AS referred for TAVI when measured in diastole and systole. This small difference is unlikely to alter clinical decisions regarding prosthesis size or suitability for TAVI.

  10. Transcatheter aortic valve implantation and cerebrovascular events: the current state of the art.

    PubMed

    Hynes, Brian G; Rodés-Cabau, Josep

    2012-04-01

    Transcatheter aortic valve implantation (TAVI) has revolutionized the care of high-risk patients with severe calcific aortic stenosis. Those considered at high or prohibitive risk of major adverse outcomes with open surgical aortic valve replacement may now be offered an alternative less-invasive therapy. Despite the rapid evolution and clinical application of this new technology, recent studies have raised concerns about adverse cerebrovascular event rates in patients undergoing TAVI. In this review, we explore the current data both in relation to procedure-related silent cerebrovascular ischemic events, as well as clinically apparent stroke. The timing of neurological events and their prognostic implications are also examined. Finally, potential mechanisms of TAVI-related cerebrovascular injury are described, in addition to efforts to minimize their occurrence.

  11. Patient evaluation and selection for transcatheter aortic valve replacement: the heart team approach.

    PubMed

    Sintek, Marc; Zajarias, Alan

    2014-01-01

    Transcatheter aortic valve replacement (TAVR) has been shown to significantly impact mortality and quality of life in patients with severe aortic stenosis (AS) who are deemed high risk for surgical aortic valve replacement (SAVR). Essential to these outcomes is proper patient selection. The multidisciplinary TAVR heart team was created to provide comprehensive patient evaluation and aid in proper selection. This review with outline the history and components of the heart team, and delineate the team's role in risk and frailty assessment, evaluation of common co-morbidities that impact outcomes, and the complex multi-modality imaging necessary for procedural planning and patient selection. The heart team is critical in determining patient eligibility and benefit and the optimal operative approach for TAVR. The future of structural heart disease will certainly require a team approach, and the TAVR heart team will serve as the successful model.

  12. Percutaneous Transcatheter Aortic Disc Valve Prosthesis Implantation: A Feasibility Study

    SciTech Connect

    Sochman, Jan

    2000-09-15

    Purpose: Over the past 30 years there have been experimental efforts at catheter-based management of aortic valve regurgitation with the idea of extending treatment to nonsurgical candidates. A new catheter-based aortic valve design is described.Methods: The new catheter-delivered valve consists of a stent-based valve cage with locking mechanism and a prosthetic flexible tilting valve disc. The valve cage is delivered first followed by deployment and locking of the disc. In acute experiments, valve implantation was done in four dogs.Results: Valve implantation was successful in all four animals. The implanted valve functioned well for the duration of the experiments (up to 3 hr).Conclusion: The study showed the implantation feasibility and short-term function of the tested catheter-based aortic disc valve. Further experimental studies are warranted.

  13. Surgical aortic-valve replacement with a transcatheter implant.

    PubMed

    Nowell, Justin L; Dewhurst, Alex; van Besouw, Jean-Pierre; Jahangiri, Marjan

    2011-04-01

    We describe a bailout procedure when surgical aortic-valve replacement was not possible due to severe calcification of the ascending aorta and the root and a very small annulus. A 21-mm CoreValve Revalving prosthesis was inserted via the aortotomy in the presence of a mitral prosthesis.

  14. 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

  15. Minimally invasive transcatheter aortic valve implantation for the treatment of rheumatic heart disease in developing countries.

    PubMed

    Saidi, Trust; Douglas, Tania S

    2016-10-01

    The treatment of rheumatic heart disease presents a medical and surgical challenge, particularly in developing countries, where the disease is prevalent. Most of these countries find it prohibitively expensive to import heart valve prostheses that are required for treatment and are largely manufactured in the United States and Europe. Even if the valves were available, the absence of facilities to conduct open-heart surgery for valve replacement results in many people from developing countries dying needlessly of the disease. To address this problem, transcatheter aortic valve implantation, an emerging, minimally invasive, treatment strategy for rheumatic heart disease, has been proposed. Areas covered: This paper reviews the literature on current valve technologies in use globally, and focuses on a minimally invasive transcatheter aortic valve implantation device and aortic valve prosthesis that have been developed by Strait Access Technologies Holdings in South Africa. Expert commentary: This new technology holds the potential of making available heart valve replacements to millions of patients in the developing world who would otherwise have no recourse to treatment.

  16. Impact of pulmonary hypertension on in-hospital outcome after surgical or transcatheter aortic valve replacement.

    PubMed

    Gutmann, Anja; Kaier, Klaus; Reinecke, Holger; Frankenstein, Lutz; Zirlik, Andreas; Bothe, Wolfgang; von Zur Mühlen, Constantin; Zehender, Manfred; Reinöhl, Jochen; Bode, Christoph; Stachon, Peter

    2017-09-20

    We aimed to analyse the impact of pulmonary hypertension (PH) on the in-hospital outcome of either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). Data from all 107,057 patients undergoing isolated SAVR or TAVR in Germany between 2007 and 2014 were provided by the German Federal Bureau of Statistics. About 18% of patients with aortic valve stenosis suffered from PH. Patients with PH had more comorbidities with consequently increased EuroSCORE (TAVR without PH: 12.3%; with PH: 24%). The presence of PH led to an increase of in-hospital strokes, bleedings, acute kidney injuries, and pacemaker implantations in both treatment groups (TAVR and SAVR), but the PH-associated increase of complications and mortality was less pronounced among patients receiving TAVR (mortality after TAVR without PH: 5.4%; with PH: 7.2%). After baseline risk adjustment, the TAVR procedure was associated with a reduced risk of in-hospital stroke (OR 0.81, p=0.011), bleeding (OR 0.22, p<0.001), and mortality (OR 0.70, p=0.005) among PH patients, and in comparison to surgical treatment. PH is a risk factor for worse outcome of SAVR and TAVR. This fact is less pronounced among TAVR patients. Our data suggest a shift towards the transcatheter approach in patients suffering from PH.

  17. Transcatheter aortic valve implantation with the Edwards Sapien 3 valve: First experiences in Turkey.

    PubMed

    Aslan, Abdullah Nabi; Baştuğ, Serdal; Kasapkara, Hacı Ahmet; Ayhan, Hüseyin; Süygün, Hakan; Keleş, Telat; Durmaz, Tahir; Akar Bayram, Nihal; Bilen, Emine; Bozkurt, Engin

    2016-12-01

    Transcatheter aortic valve implantation (TAVI) has shown promising results in patients with severe aortic stenosis (AS) at high risk for open heart surgery. We aimed to evaluate outcomes of patients who underwent TAVI with Edwards SAPIEN 3 Transcatheter Heart Valve (S3), a second-generation TAVI device. Between November 2014 and June 2016, 31 high-risk patients received balloon-expandable S3 valve at Atatürk Training and Research Hospital that has the largest case series in Turkey. Mean age of the patients was 76.1±12.6 years. Mean Society of Thoracic Surgeons and logistic European System for Cardiac Operative Risk Evaluation scores were 7.8%±3.1 and 31.4%±17.6, respectively. S3 valve was implanted in 27 patients via transfemoral approach and via trans-subclavian approach in 4 patients under local (n=29) or general (n=2) anesthesia. Procedural success rate was 100% (23 mm, n=7; 26 mm, n=16; 29 mm, n=8). Paravalvular aortic regurgitation (PAR) was absent or trivial in 29 (93.6%) patients and mild in 2 (6.4%) patients. Permanent pacemaker implantation (PPI) was required in 2 (6.4%) patients during the procedure, and in-hospital mortality occurred in 1 (3.2%) of those 2 patients. S3 valve is associated with higher rate of device success and lower incidence of PAR, peripheral vascular complications, and need for new PPI.

  18. 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

  19. Automatic 3D aortic annulus sizing by computed tomography in the planning of transcatheter aortic valve implantation.

    PubMed

    Queirós, Sandro; Dubois, Christophe; Morais, Pedro; Adriaenssens, Tom; Fonseca, Jaime C; Vilaça, João L; D'hooge, Jan

    Accurate imaging assessment of aortic annulus (AoA) dimension is paramount to decide on the correct transcatheter heart valve (THV) size for patients undergoing transcatheter aortic valve implantation (TAVI). We evaluated the feasibility and accuracy of a novel automatic framework for multidetector row computed tomography (MDCT)-based TAVI planning. Among 122 consecutive patients undergoing TAVI and retrospectively reviewed for this study, 104 patients with preoperative MDCT of sufficient quality were enrolled and analyzed with the proposed software. Fully automatic (FA) and semi-automatic (SA) AoA measurements were compared to manual measurements, with both automated and manual-based interobserver variability (IOV) being assessed. Finally, the effect of these measures on hypothetically selected THV size was evaluated against the implanted size, as well as with respect to manually-derived sizes. FA analysis was feasible in 92.3% of the cases, increasing to 100% if using the SA approach. Automatically-extracted measurements showed excellent agreement with manually-derived ones, with small biases and narrow limits of agreement, and comparable to the interobserver agreement. The SA approach presented a statistically lower IOV than manual analysis, showing the potential to reduce interobserver sizing disagreements. Moreover, the automated approaches displayed close agreement with the implanted sizes, similar to the ones obtained by the experts. The proposed automatic framework provides an accurate and robust tool for AoA measurements and THV sizing in patients undergoing TAVI. Copyright © 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

  20. Patient values and preferences on transcatheter or surgical aortic valve replacement therapy for aortic stenosis: a systematic review

    PubMed Central

    Lytvyn, Lyubov; Guyatt, Gordon H; Manja, Veena; Siemieniuk, Reed A; Zhang, Yuan; Agoritsas, Thomas; Vandvik, Per O

    2016-01-01

    Objective To investigate patients' values and preferences regarding aortic valve replacement therapy for aortic stenosis. Setting Studies published after transcatheter aortic valve insertion (TAVI) became available (2002). Participants Adults with aortic stenosis who are considering or have had valve replacement, either TAVI or via surgery (surgical aortic valve replacement, SAVR). Outcome measures We sought quantitative measurements, or qualitative descriptions, of values and preferences. When reported, we examined correlations between preferences and objective (eg, ejection fraction) or subjective (eg, health-related quality of life) measures of health. Results We reviewed 1348 unique citations, of which 2 studies proved eligible. One study of patients with severe aortic stenosis used a standard gamble study to ascertain that the median hypothetical mortality risk patients were willing to tolerate to achieve full health was 25% (IQR 25–50%). However, there was considerable variability; for mortality risk levels defined by current guidelines, 130 participants (30%) were willing to accept low-to-intermediate risk (≤8%), 224 (51%) high risk (>8–50%) and 85 (19%) a risk that guidelines would consider prohibitive (>50%). Study authors did not, however, assess participants' understanding of the exercise, resulting in a potential risk of bias. A second qualitative study of 15 patients identified the following factors that influence patients to undergo assessment for TAVI: symptom burden; expectations; information support; logistical barriers; facilitators; obligations and responsibilities. The study was limited by serious risk of bias due to authors' conflict of interest (5/9 authors industry-funded). Conclusions Current evidence on patient values and preferences of adults with aortic stenosis is very limited, and no studies have enrolled patients deciding between TAVI and SAVR. On the basis of the data available, there is evidence of variability in individual

  1. Management of left main coronary artery obstruction after transcatheter aortic valve replacement utilizing a periscope approach.

    PubMed

    Drexel, Todd; Helmer, Gregory; Garcia, Santiago; Raveendran, Ganesh

    2017-09-20

    Coronary obstruction is a rare but potentially fatal complication of transcatheter aortic valve replacement (TAVR). It can result from native leaflet or stent frame obstruction of the coronary ostia. There are reports detailing the difficulty of percutaneous coronary intervention following TAVR, but none that describe a periscope approach to access the left main ostia in the presence of a braided nitinol frame. This report describes an alternative approach to access a coronary artery when the valve stent struts are prohibitive to equipment delivery. © 2017 Wiley Periodicals, Inc.

  2. A Novel Technique for Prosthetic Valve Retrieval After Transcatheter Aortic Valve Embolization.

    PubMed

    Giannini, Francesco; Ruparelia, Neil; Del Furia, Francesca; Romano, Vittorio; Ancona, Marco; Mangieri, Antonio; Regazzoli, Damiano; Latib, Azeem; Godino, Cosmo; Ancona, Francesco; Candilio, Luciano; Jabbour, Richard; Colombo, Antonio; Montorfano, Matteo

    2017-07-01

    Although the rate of procedural complications during transcatheter aortic valve implantation has decreased because of technological advancement and increased operator experience, device embolization remains a rare but potentially fatal complication, even with new generation devices. We report, to our knowledge, the first case of Portico valve (St Jude Medical, Minneapolis, MN) migration despite apparent optimal initial implantation depth, which was retrieved using a novel strategy after failure of a traditional retrieval technique. We also describe a mechanism of left coronary artery systolic perfusion with diastolic backflow, which led to myocardial ischemia. Copyright © 2017 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  3. Quantifying the Shift Toward Transcatheter Aortic Valve Replacement in Low-Risk Patients: A Meta-Analysis.

    PubMed

    De Sciscio, Paolo; Brubert, Jacob; De Sciscio, Michele; Serrani, Marta; Stasiak, Joanna; Moggridge, Geoff D

    2017-06-01

    In recent years, use of transcatheter aortic valve replacement has expanded to include patients at intermediate- and low-risk cohorts. We sought to determine disease prevalence and treatment distribution including transcatheter aortic valve replacement eligibility in low-risk patients across 37 advanced economies. Four systematic searches were conducted across MEDLINE, EMBASE, and the Cochrane database for studies evaluating disease prevalence, severity, decision making, and survival in patients with aortic stenosis. Estimates of disease prevalence and treatment eligibility were calculated using stochastic simulation and population data for the 37 countries comprising the International Monetary Fund's advanced economies index. Fifty-six studies comprising 42 965 patients were included across 5 domains: prevalence, severity, symptom status, treatment modality, and outcome. The pooled prevalence in the general population aged 60 to 74 years and >75 years was 2.8% (95% confidence interval [CI], 1.4%-4.1%) and 13.1% (95% CI, 8.2%-17.9%), respectively-corresponding to an estimated 16.1 million (95% CI, 12.2-20.3) people in 37 advanced economies. Of these, an estimated 3.2 million (95% CI, 2.2-4.4) patients have severe aortic stenosis with 1.9 million (95% CI, 1.3-2.6) eligible for surgical aortic valve replacement. There are ≈485 230 (95% CI, 284 550-66 7350) high-risk/inoperable patients, 152 690 (95% CI, 73 410-263 000) intermediate-risk patients, and 378 890 (95% CI, 205 130-610 210) low-risk patients eligible for transcatheter aortic valve replacement. With a prevalence of 4.5%, an estimated 16.1 million people aged ≥60 years across 37 advanced economies have aortic stenosis. Of these, there are ≈1.9 million patients eligible for surgical aortic valve replacement and 1.0 million patients eligible for transcatheter aortic valve replacement. © 2017 American Heart Association, Inc.

  4. Simulation of Transcatheter Aortic Valve Replacement in patient-specific aortic roots: Effect of crimping and positioning on device performance.

    PubMed

    Bianchi, Matteo; Ghosh, Ram P; Marom, Gil; Slepian, Marvin J; Bluestein, Danny

    2015-01-01

    Calcific aortic valve disease (CAVD) is a cardiovascular condition that causes the progressive narrowing of the aortic valve (AV) opening, due to the growth of bone-like deposits all over the aortic root (AR). Transcatheter aortic valve replacement (TAVR), a minimally invasive procedure, has recently become the only lifesaving solution for patients that cannot tolerate the standard surgical valve replacement. However, adverse effects, such as AR injury or paravalvular leakage (PVL), may occur as a consequence of a sub-optimal procedure, due to the presence of calcifications in situ. Additionally, the crimping required for delivering the valve via stenting may damage the valve. The aim of the present study is to comparatively assess the crimping mechanics of the commercialized Edwards SAPIEN valve and an alternative polymeric valve (Polynova, Inc) and to evaluate the effect of different TAVR deployment positions using patient-specific numerical models. The optimal deployment location for achieving better patient outcomes was calculated and based on the interactions between the TAVR stent and the native AR. Results demonstrated that the Polynova valve withstands the crimping process better than the SAPIEN valve. Furthermore, deployment simulations showed the role that calcifications deposits may play in the TAVR sub-optimal valve anchoring to the AV wall, leading to the presence of gaps that result in PVL.

  5. AANA Journal Course: Update for nurse anesthetists--part-4--transcatheter aortic valve replacement.

    PubMed

    Contrera, Peggy; Cushing, Mary

    2013-10-01

    Aortic stenosis is the most frequently acquired heart disease, and the prevalence is rising because of the aging population. If the disease is left untreated, survival in symptomatic patients averages only 2 to 3 years. Surgical aortic valve replacement is the only definitive treatment, yet 30% of elderly patients are not considered candidates because the presence of comorbidities makes the risk of sternotomy and cardiopulmonary bypass prohibitively high. Transcatheter aortic valve replacement (TAVR) is an innovative, high-tech, less invasive alternative. The procedure is usually performed using general anesthesia and a multidisciplinary team from interventional cardiology and cardiothoracic surgery in a "hybrid" operating environment with advanced imaging capabilities. There are 2 major catheter-based approaches to the aortic valve: retrograde percutaneous through the femoral artery and aorta or direct antegrade through a thoracotomy and the left ventricular apex. Apnea and rapid ventricular pacing are used to interrupt cardiac ejection during balloon valvuloplasty and prosthesis implantation. The most significant complications include vascular damage, stroke, paravalvular aortic insufficiency, and heart block. Outcomes studies comparing TAVR with medical management demonstrate improved patient survival, functional status, and quality of life. Currently TAVR is considered the treatment of choice for patients who are not surgical candidates and is a proven alternative for high-risk surgical candidates.

  6. Recurrent angina from chronic coronary obstruction following transcatheter aortic valve implantation

    PubMed Central

    Kabach, Mohamad; Alrifai, Abdulah; Furlan, Stefanie; Alahdab, Fares

    2016-01-01

    Severe aortic stenosis and coronary artery disease often coexist. Coronary angiography (CA) and percutaneous coronary intervention (PCI) can be challenging in patients with prior transcatheter aortic valve implantation (TAVI). Depending on the type and position of the implanted valve, the procedure can be challenging or even unfeasible due to interference of diagnostic catheters and valve parts. The correct positioning of the TAVI prosthesis during TAVI was identified as an important factor with regard to the feasibility of subsequent CA or PCI. TAVI has been also associated with vascular, cerebrovascular and conduction complication. One is rare but life-threatening complication, coronary ostial obstruction. Coronary ostial obstruction can develop, especially if a safety check of more than 10 mm of coronary ostial height is not taken into consideration during TAVI. This complication can cause recurrent episodes of angina and can severely worsen the patient's cardiac systolic function. PMID:27390671

  7. Surgery for fulminant prosthetic valve endocarditis after transapical transcatheter aortic valve-in-valve implantation.

    PubMed

    Wilbring, Manuel; Tugtekin, Sems Malte; Matschke, Klaus; Kappert, Utz

    2014-02-01

    We report the clinical course of a patient with a history of transapical aortic "valve-in-valve" transcatheter aortic valve implantation (TAVI), actually suffering from prosthetic valve endocarditis. The patient now underwent cardiac surgery as a salvage procedure. The procedure itself was uneventful, but the patient died several days postoperative due to persisting sepsis. The present case raises the question, how to deal with high-risk patients, once considered unsuitable for cardiac surgery in presence of prosthetic valve infection? Up to now, there exists only insufficient knowledge about incidence, clinical course, and effectiveness of treatment strategies for prosthetic valve endocarditis after TAVI. A review of the available literature is given. Georg Thieme Verlag KG Stuttgart · New York.

  8. Comparison of complete versus incomplete stent frame expansion after transcatheter aortic valve implantation with Medtronic CoreValve bioprosthesis.

    PubMed

    Jilaihawi, Hasan; Chin, Derek; Spyt, Tomasz; Jeilan, Mohamed; Vasa-Nicotera, Mariuca; Mohamed, Noor; Bence, Johan; Logtens, Elaine; Kovac, Jan

    2011-06-15

    We sought to determine the significance of incomplete stent frame expansion after transcatheter aortic valve implantation with the Medtronic-CoreValve device. Incomplete coronary stent expansion is a well-described phenomenon. Transcatheter valves are mounted on stents; however, the incidence of incomplete stent expansion after transcatheter aortic valve implantation, its sequelae and predictors are poorly elucidated. The 18Fr CoreValve revalving system was used to treat anatomically and clinically suitable patients with severe calcific aortic stenosis. The postdeployment stent dimensions were measured on fluoroscopic images at multiple levels of the stent frame. Incomplete expansion at each was defined as <100% expected and complete expansion as ≥100%. These parameters were correlated to the hemodynamic and clinical end points. A total of 50 consecutive patients underwent transcatheter aortic valve implantation with the Medtronic-CoreValve at a single center from January 2007 to December 2008. For the inflow portion, incomplete expansion was seen in 54% of patients and was unrelated to the aortic valve area, peak or mean aortic valve gradients, or measures of aortic regurgitation, although it was paradoxically associated with a lower incidence of prosthesis-patient mismatch. Incomplete expansion of the constrained portion was seen in 62% of the patients and displayed a trend toward a greater incidence of aortic regurgitation grade 2 or greater, although this was rare. Incomplete expansion of the Medtronic CoreValve stent frame is common. For the most part, valvular hemodynamic function was satisfactory, regardless of the degree of expansion of the stent frame that carries it and a strategy of reluctant postdilation in the context of incomplete stent frame expansion was supported. Copyright © 2011 Elsevier Inc. All rights reserved.

  9. Novel Use of an Apical-Femoral Wire Rail to Assist With Transfemoral Transcatheter Aortic Valve Replacement

    PubMed Central

    Don, Creighton W.; Kim, Michael S.; Verrier, Edward D.; Aldea, Gabriel S.; Dean, Larry S.; Reisman, Mark; Mokadam, Nahush A.

    2015-01-01

    The inability to reposition or retrieve balloon-expandable transcatheter aortic valves once they have been deployed requires implantation of the valve in the descending aorta or open surgical procedures to extract the valve. We describe the challenging transfemoral delivery of an Edwards Lifesciences Sapien valve wherein we had difficulty crossing the aortic valve and the guidewire position was compromised. We performed a transapical puncture to snare the guidewire and create a left ventricular to femoral wire rail, allowing us to deliver the transfemoral transcatheter valve, salvaging a situation where we would have been required to implant the valve in the descending aorta. We believe this is the first time this technique has been reported and represents an important method to facilitate delivery of transcatheter valves where guidewire support is insufficient or lost. PMID:24907088

  10. 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.

  11. Pathophysiology, incidence and predictors of conduction disturbances during Transcatheter Aortic Valve Implantation.

    PubMed

    Barbanti, Marco; Gulino, Simona; Costa, Giuliano; Tamburino, Corrado

    2017-02-01

    Over the past decade, transcatheter aortic valve implantation (TAVI) has evolved rapidly toward an extremely reproducible, safe and effective procedure, with a marked reduction of its related complications. However, the occurrence of conduction disturbances and the need for permanent pacemaker implantation (PPI) after TAVI remains a concern. Areas covered: In this article review, we will go through the mechanisms involved in conduction disturbances after TAVI, and we will discuss the key aspects of pathophysiology, incidence and predictors of conduction disturbances following Transcatheter Aortic Valve Implantation. The evaluation of patient's valve anatomy and the selection of the most appropriate prosthesis have been proposed as a valuable options to reduce the incidence of conductions disturbances. Moreover, in recent times, a great number of new TAVI devices, so-called 'second-generation devices', have been introduced to address the limitations of the first-generation devices, including conduction disturbance, with scarce results. Expert commentary: Conduction disturbances after TAVI are increasingly recognized as an important issue in TAVI complications. Further characterization of the procedural- and patient-related factors that contribute to the development of conduction abnormalities will help to improve prosthesis designs and patient selection, making TAVI even more safer.

  12. Conduction disturbances after transcatheter aortic valve implantation procedures – predictors and management

    PubMed Central

    Reguła, Rafał; Bujak, Kamil; Chodór, Piotr; Długaszek, Michał; Gąsior, Mariusz

    2016-01-01

    Transcatheter aortic valve implantation (TAVI) has become a safe and efficient alternative to cardiac surgery in patients with severe aortic stenosis. In many countries the number of performed TAVI procedures equals the number of surgical implantations. Indications for TAVI are becoming more liberal, allowing a wider spectrum of patients to benefit from the advantages of transcatheter therapy. Due to its invasive nature, TAVI is associated with some complications such as conduction disturbances. Although these disturbances are usually not lethal, they have a great influence on patients’ state and long term-survival. The most relevant and common are His’ bundle branch blocks, atrioventricular blocks, and need for permanent pacemaker implantation. With the frequency at 10% to even 50%, conduction abnormalities are among the most important TAVI-related adverse events. Risk factors for conduction disturbances include age, anatomy of the heart, periprocedural factors, type of implanted valve, and comorbidities. Severity of occurring complications varies; therefore selection of a proper treatment approach is required. Considered as the most effective management, permanent pacemaker implantation turned out to negatively influence both recovery and survival. Moreover, there is no expert consensus on use of resynchronization therapy after TAVI. In this paper, the authors present a comprehensive analysis of the most common conduction disturbances accompanying TAVI, factors related to their occurrence, and treatment approach. PMID:27625682

  13. 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.

  14. Transaortic Transcatheter Aortic valve implantation using Edwards Sapien valve: a novel approach.

    PubMed

    Bapat, Vinayak; Khawaja, Muhammed Z; Attia, Rizwan; Narayana, Ashok; Wilson, Karen; Macgillivray, Kirsty; Young, Christopher; Hancock, Jane; Redwood, Simon; Thomas, Martyn

    2012-04-01

    To evaluate feasibility and outcome of Transoartic Transcatheter Sapien valve implantation. Transcatheter Aortic valve implantation (TAVI) using the Edwards SAPIEN device (Edwards LifeScience, Irvine, CA) is usually performed via the transfemoral (TF) or transapical (TA) routes. Some patients are not suitable for these approaches. We report our experience with the novel transaortic (TAo) approach via a partial upper sternotomy and discuss the advantages and future applications. Between January 2008 to March 2011 193 patients with severe aortic stenosis underwent TAVI with the Edwards SAPIEN bioprosthesis at the St. Thomas' Hospital, London. 108 patients were unable to undergo a TF-TAVI and of those 17 were accepted for a TAo-TAVI on the basis of anatomy, risk, LV function, and significant respiratory disease. The TAo-TAVI group (n = 17) had more prevalent respiratory disease than the TA-TAVI group (47.0% vs. 18.7%, P = 0.011). Otherwise the groups were similar in demographics and history. Despite this the 30 day mortalities were not significantly different between the groups (TAo-TAVI 4.3% at 30 days versus TA-TAVI 7.7%, P = 0.670). There were no significant differences in procedural complications. The TA-TAVI approach may not be desirable in patients with severe chest deformity, poor lung function or poor left ventricular function. TAo-TAVI via a partial sternotomy is safe and feasible in these patients. Copyright © 2011 Wiley Periodicals, Inc.

  15. Combined venoarterial extracorporeal membrane oxygenation and transcatheter aortic valve implantation for the treatment of acute aortic prosthesis dysfunction in a high-risk patient.

    PubMed

    Pergolini, Amedeo; Zampi, Giordano; Tinti, Maria Denitza; Polizzi, Vincenzo; Pino, Paolo Giuseppe; Pontillo, Daniele; Musumeci, Francesco; Luzi, Giampaolo

    2016-01-01

    We describe the case of a patient with acute bioprosthesis dysfunction in cardiogenic shock, in whom hemodynamic support was provided by venoarterial extracorporeal membrane oxygenation, and successfully treated by transcatheter aortic valve implantation. Copyright © 2016 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

  16. 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.

  17. Direct Transcatheter Heart Valve Implantation Versus Implantation With Balloon Predilatation: Insights From the Brazilian Transcatheter Aortic Valve Replacement Registry.

    PubMed

    Bernardi, Fernando L M; Ribeiro, Henrique B; Carvalho, Luiz A; Sarmento-Leite, Rogerio; Mangione, José A; Lemos, Pedro A; Abizaid, Alexandre; Grube, Eberhard; Rodés-Cabau, Josep; de Brito, Fábio S

    2016-08-01

    Direct transcatheter aortic valve replacement (TAVR) is regarded as having potential advantages over TAVR with balloon aortic valve predilatation (BAVP) in reducing procedural complications, but there are few data to support this approach. Patients included in the Brazilian TAVR registry with CoreValve and Sapien-XT prosthesis were compared according to the implantation technique, with or without BAVP. Clinical and echocardiographic data were analyzed in overall population and after propensity score matching. A total of 761 consecutive patients (BAVP=372; direct-TAVR=389) were included. Direct-TAVR was possible in 99% of patients, whereas device success was similar between groups (BAVP=81.2% versus direct-TAVR=78.1%; P=0.3). No differences in clinical outcomes at 30 days and 1 year were observed, including all-cause mortality (7.6% versus 10%; P=0.25 and 18.1% versus 24.5%; P=0.07, respectively) and stroke (2.8% versus 3.8%; P=0.85 and 5.5% versus 6.8%; P=0.56, respectively). Nonetheless, TAVR with BAVP was associated with a higher rate of new onset persistent left bundle branch block with the CoreValve (47.7% versus 35.1%; P=0.01 at 1 year). Mean gradient and incidence of moderate/severe aortic regurgitation were similar in both groups at 1 year (11% versus 13.3%; P=0.57 and 9.8±5.5 versus 8.7±4.3; P=0.09, respectively). After propensity score matching analysis, all-cause mortality and stroke remained similar. By multivariable analysis, BAVP and the use of CoreValve were independent predictors of new onset persistent left bundle branch block. The 2 TAVR strategies, with or without BAVP, provided similar clinical and echocardiographic outcomes over a midterm follow-up although BAVP was associated with a higher rate of new onset persistent left bundle branch block, particularly in patients receiving a CoreValve. © 2016 American Heart Association, Inc.

  18. Surgical versus percutaneous treatment of aortic coarctation: new standards in an era of transcatheter repair.

    PubMed

    Luijendijk, Paul; Bouma, Berto J; Groenink, Maarten; Boekholdt, Matthijs; Hazekamp, Mark G; Blom, Nico A; Koolbergen, Dave R; de Winter, Robbert J; Mulder, Barbara J M

    2012-12-01

    Aortic coarctation is a common congenital cardiovascular defect, which can be diagnosed over a wide range of ages and with varying degrees of severity. Surgery has proven to be an effective treatment for the management of native aortic coarctation, and remains the treatment of choice in neonates. Balloon angioplasty with or without stenting has evolved rapidly over the past decade. Balloon angioplasty is the treatment of choice in children with re-coarctation, and currently available immediate results in native coarctation are similar with regards to gradient reduction as compared with surgery. However, both treatment options carry the risk of restenosis and aortic wall complications, especially after balloon angioplasty without stenting in native coarctation. On the other hand, stent implantation has shown excellent short-term results in both children beyond infancy and in adults with native coarctation. In patients with recurrent coarctation who are at high surgical risk, balloon angioplasty and stent repair offer a less invasive and equally effective method. Stent repair is preferred over balloon angioplasty in adults and outgrown children with a recurrent coarctation, as the risk for re-coarctation and aneurysm formation seems to be lower. Data with regard to long-term outcome after percutaneous treatment strategies are scarce. This review summarizes the current insights in the efficacy and safety of both surgical and transcatheter treatment options for aortic coarctation.

  19. 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.

  20. 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.

  1. Percutaneous Aortic Balloon Valvuloplasty and Intracardiac Adrenaline in Electromechanical Dissociation as Bridge to Transcatheter Aortic Valve Implantation.

    PubMed

    Chaara, Jawad; Meier, Pascal; Ellenberger, Christophe; Gasche, Yvan; Bendjelid, Karim; Noble, Stephane; Roffi, Marco

    2015-07-01

    This report describes an emergent balloon aortic valvuloplasty (BAV) procedure performed under cardiopulmonary resuscitation in a 79-year-old man with severe symptomatic aortic stenosis (mean gradient 78 mm Hg, valve area 0.71 cm, and left ventricular ejection fraction 40%) awaiting surgery and who was admitted for heart failure rapidly evolving to cardiogenic shock and multiorgan failure. Decision was made to perform emergent BAV. After crossing the valve with a 6 French catheter, the patient developed an electromechanical dissociation confirmed at transesophageal echocardiography and cardiac arrest. Manual chest compressions were initiated along with the application of high doses of intravenous adrenaline, and BAV was performed under ongoing resuscitation. Despite BAV, transoesophageal echocardiography demonstrated no cardiac activity. At this point, it was decided to advance a pigtail catheter over the wire already in place in the left ventricle and to inject intracardiac adrenaline (1 mg, followed by 5 mg). Left ventricular contraction progressively resumed and, in the absence of aortic regurgitation, an intraaortic balloon pump was inserted. The patient could be weaned from intraaortic balloon pump and vasopressors on day 1, extubated on day 6, and recovered from multiorgan failure. In the absence of neurologic deficits, he underwent uneventful transcatheter aortic valve implantation on day 12 and was discharged to a cardiac rehabilitation program on day 30. At 3-month follow-up, he reported dyspnea NYHA class II as the only symptom.This case shows that severe aortic stenosis leading to electromechanical dissociation may be treated by emergent BAV and intracardiac administration of high-dose adrenaline. Intracardiac adrenaline may be considered in case of refractory electromechanical dissociation occurring in the cardiac catheterization laboratory.

  2. Improvement of right ventricular function with transcatheter aortic valve implantation.

    PubMed

    Ayhan, Hüseyin; Durmaz, Tahir; Keleş, Telat; Sari, Cenk; Aslan, Abdullah Nabi; Kasapkara, Haci Ahmet; Bozkurt, Engin

    2014-06-01

    It has been demonstrated that right ventricular systolic dysfunction develops soon after surgical aortic valve replacement (s-AVR). While the impact of s-AVR or TAVI on the function of the left ventricle has been studied with various imaging modalities, little is known about the impact on right ventricular function (RVF). In the current study, we evaluated the impact of TAVI on RVF using conventional echocardiography parameters. Echocardiography was performed prior to 24 h, 1 month and 6 months after TAVI. RVF was assessed using (1) tricuspid annular plane systolic excursion (TAPSE); (2) RV Tissue Doppler Imaging (S'); (3) right ventricular systolic pressure (RVSP); (4) Fractional area change (FAC); and (5) RV ejection fraction (RVEF). TAVI was performed through the subclavian artery in two patients and femoral artery in 48 patients with an Edwards Sapien XT valve. TAVI was performed on 50 patients between the dates of December 2012 and June 2013. After TAVI, a statistically significant improvement was observed for all parameters related to RVF (RVSP, RVEF, TAPSE, FAC, RVTDI S'). During the 1st and 6th months this statistically significant improvement continued in TAPSE and FAC, and there was no deterioration in RVSP, RVEF, and RVTDI S during the 1st month but a statistically significant improvement continued in the 6th month. RVF assessed by conventional echocardiography did not deteriorate after TAVI in early and midterm follow-up. Further, TAVI provides improvement of RVF and can safely and efficiently be performed in patients with impaired RVF.

  3. 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

  4. Prediction of fluoroscopic angulations for transcatheter aortic valve implantation by CT angiography: influence on procedural parameters.

    PubMed

    Hell, Michaela M; Biburger, Lukas; Marwan, Mohamed; Schuhbaeck, Annika; Achenbach, Stephan; Lell, Michael; Uder, Michael; Arnold, Martin

    2017-05-01

    Repeated angiograms to achieve an exactly orthogonal visualization of the aortic valve plane can substantially contribute to the total contrast amount required for transcatheter aortic valve implantation (TAVI). We investigated whether pre-procedural identification of an optimal fluoroscopic projection by cardiac computed tomography (CT) can significantly reduce the amount of a procedure-related contrast agent compared with angiographic determination of suitable angulations. Eighty consecutive patients (81 ± 5 years, 55% male) with symptomatic severe aortic valve stenosis and normal renal function who underwent cardiac CT prior to TAVI were prospectively randomized. In 40 patients, a CT-predicted suitable angulation was used for the first aortic angiogram (CT cohort); in the other 40 patients, the first aortogram was acquired at LAO 10°/cranial 10 (angiography cohort). Additional aortograms were performed if no satisfactory view of the aortic valve plane was obtained. The number of aortograms needed to achieve a satisfactory fluoroscopic projection (1.2 ± 0.6 vs. 3.2 ± 1.7; P < 0.001) and the total amount of contrast agent per TAVI procedure were significantly lower in the CT cohort (95 ± 21 vs. 125 ± 36 mL; P < 0.001). Incidence of acute kidney injury was not significantly different. There was no significant difference regarding radiation dose, time of procedure, degree of post-procedural aortic regurgitation, complications and 30-day mortality between the cohorts. Pre-procedural identification of a suitable fluoroscopic projection by cardiac CT significantly reduces a procedural contrast agent volume required for TAVI.

  5. 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).

  6. Computed tomography-derived skeletal muscle index: A novel predictor of frailty and hospital length of stay after transcatheter aortic valve replacement.

    PubMed

    Dahya, Vishal; Xiao, Jingjie; Prado, Carla M; Burroughs, Penny; McGee, Dan; Silva, Aline C; Hurt, Julian E; Mohamed, Shafi G; Noel, Thomas; Batchelor, Wayne

    2016-12-01

    To determine the prevalence of low skeletal muscle mass in patients undergoing transcatheter aortic valve replacement (TAVR) and whether skeletal muscle mass measured from preoperative computed tomography (CT) images provides value in predicting postoperative length of stay (LOS).

  7. Echocardiographic vs Invasive Measurement of the Direct Flow Transcatheter Aortic Heart Valve Mean Gradient: Contradictory or Complementary?

    PubMed

    Panoulas, Vasileios F; Latib, Azeem; Agricola, Eustachio; Baumgartner, Helmut; Alfieri, Ottavio; Colombo, Antonio

    2015-10-01

    In this case report, we explain the reason behind observed differences in echocardiographic and invasively measured mean aortic valve gradient after transcatheter aortic valve implantation. A 25-mm Direct Flow valve (Direct Flow Medical Inc, Santa Rosa, CA) was successfully implanted in a patient with severe aortic stenosis via the transfemoral route. The discrepancy between invasive and echocardiographic measurements could be explained by the combination of a non-flat velocity profile inside the tubular structure of the Direct Flow valve, which can cause local low pressure fields that result in true high gradients detected using Doppler, and pressure recovery. Copyright © 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  8. Effect of Availability of Transcatheter Aortic-Valve Replacement on Clinical Practice.

    PubMed

    Reinöhl, Jochen; Kaier, Klaus; Reinecke, Holger; Schmoor, Claudia; Frankenstein, Lutz; Vach, Werner; Cribier, Alain; Beyersdorf, Friedhelm; Bode, Christoph; Zehender, Manfred

    2015-12-17

    Since the adoption of transcatheter aortic-valve replacement (TAVR), questions have been raised about its effect on clinical practice in comparison with the effect of surgical aortic-valve replacement, which is considered the current standard of care. Complete nationwide data are useful in examining how the introduction of a new technique influences previous clinical standards. We analyzed data on characteristics of patients and in-hospital outcomes for all isolated TAVR and surgical aortic-valve replacement procedures performed in Germany from 2007 to 2013. In total, 32,581 TAVR and 55,992 surgical aortic-valve replacement procedures were performed. The number of TAVR procedures increased from 144 in 2007 to 9147 in 2013, whereas the number of surgical aortic-valve replacement procedures decreased slightly, from 8622 to 7048. Patients undergoing TAVR were older than those undergoing surgical aortic-valve replacement (mean [±SD] age, 81.0±6.1 years vs. 70.2±10.0 years) and at higher preoperative risk (estimated logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation], 22.4% vs. 6.3%, on a scale of 0 to 100%, with higher scores indicating greater risk and a score of more than 20% indicating high surgical risk). In-hospital mortality decreased in both groups between 2007 and 2013 (from 13.2% to 5.4% with TAVR and from 3.8% to 2.2% with surgical aortic-valve replacement). The incidences of stroke, bleeding, and pacemaker implantation (but not acute kidney injury) also declined. The use of TAVR increased markedly in Germany between 2007 and 2013; the concomitant reduction in the use of surgical aortic-valve replacement was moderate. Patients undergoing TAVR were older and at higher procedural risk than those undergoing surgical aortic-valve replacement. In-hospital mortality decreased in both groups but to a greater extent among patients undergoing TAVR. (Funded by the Heart Center, Freiburg University.).

  9. Computed tomography assessment for transcatheter aortic valve in valve implantation: The vancouver approach to predict anatomical risk for coronary obstruction and other considerations.

    PubMed

    Blanke, Philipp; Soon, Jeanette; Dvir, Danny; Park, Jong K; Naoum, Christopher; Kueh, Shaw-Hua; Wood, David A; Norgaard, Bjarne L; Selvakumar, Kapilan; Ye, Jian; Cheung, Anson; Webb, John G; Leipsic, Jonathon

    Valve-in-valve implantation of a transcatheter heart valve into a failed bioprosthetic heart valve has emerged as a treatment alternative to repeat conventional surgery. This requires careful pre-procedural assessment using non-invasive imaging to identify patients at risk for procedure related adverse events, such as ostial coronary occlusion. Herein we report how to comprehensively assess aortic root anatomy using computed tomography prior to transcatheter valve implantation for failed bioprosthetic aortic valves.

  10. Patient values and preferences on transcatheter or surgical aortic valve replacement therapy for aortic stenosis: a systematic review.

    PubMed

    Lytvyn, Lyubov; Guyatt, Gordon H; Manja, Veena; Siemieniuk, Reed A; Zhang, Yuan; Agoritsas, Thomas; Vandvik, Per O

    2016-09-29

    To investigate patients' values and preferences regarding aortic valve replacement therapy for aortic stenosis. Studies published after transcatheter aortic valve insertion (TAVI) became available (2002). Adults with aortic stenosis who are considering or have had valve replacement, either TAVI or via surgery (surgical aortic valve replacement, SAVR). We sought quantitative measurements, or qualitative descriptions, of values and preferences. When reported, we examined correlations between preferences and objective (eg, ejection fraction) or subjective (eg, health-related quality of life) measures of health. We reviewed 1348 unique citations, of which 2 studies proved eligible. One study of patients with severe aortic stenosis used a standard gamble study to ascertain that the median hypothetical mortality risk patients were willing to tolerate to achieve full health was 25% (IQR 25-50%). However, there was considerable variability; for mortality risk levels defined by current guidelines, 130 participants (30%) were willing to accept low-to-intermediate risk (≤8%), 224 (51%) high risk (>8-50%) and 85 (19%) a risk that guidelines would consider prohibitive (>50%). Study authors did not, however, assess participants' understanding of the exercise, resulting in a potential risk of bias. A second qualitative study of 15 patients identified the following factors that influence patients to undergo assessment for TAVI: symptom burden; expectations; information support; logistical barriers; facilitators; obligations and responsibilities. The study was limited by serious risk of bias due to authors' conflict of interest (5/9 authors industry-funded). Current evidence on patient values and preferences of adults with aortic stenosis is very limited, and no studies have enrolled patients deciding between TAVI and SAVR. On the basis of the data available, there is evidence of variability in individual values and preferences, highlighting the importance of well-informed and

  11. Aortic regurgitation with second versus third-generation balloon-expandable prostheses in patients undergoing transcatheter aortic valve implantation.

    PubMed

    Jochheim, David; Zadrozny, Magda; Theiss, Hans; Baquet, Moritz; Maimer-Rodrigues, Fatima; Bauer, Axel; Lange, Philipp; Greif, Martin; Kupatt, Christian; Hausleiter, Jörg; Hagl, Christian; Massberg, Steffen; Mehilli, Julinda

    2015-06-01

    Our aim was to assess the incidence of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) with the second (SXT) versus third-generation (S3) balloon-expandable SAPIEN prosthesis in patients with symptomatic aortic stenosis (AS). Of 634 patients undergoing TAVI in our centre from May 2010 to July 2014, 354 were treated with the SXT and 100 with the S3 prosthesis. The primary outcome was the incidence of more-than-mild post-TAVI AR at discharge. Secondary outcomes were 30-day incidence of all-cause death, any bleeding complications and need for new pacemaker. The incidence of the primary outcome was 2.0% vs. 8.8%, p<0.01 with S3 compared to SXT, and S3 use was the only independent predictor of post-TAVI AR (odds ratio 0.54; 95% CI: 0.33 to 0.89). At 30 days, there were no differences in mortality (1.0% vs. 4.2%, p=0.13) and pacemaker rate (12.0% vs. 10.5%, p=0.59) between S3 and SXT. S3-treated patients less frequently had bleeding complications (24.0% vs. 41.8%, p<0.01) and more often had permanent new left bundle branch block (22.0% vs. 7.1%, p<0.001). Compared to the SXT, the use of the S3 prosthesis substantially reduces post-TAVI aortic regurgitation. Longer follow-up is needed to assess if this finding translates to better clinical outcomes.

  12. Two-year outcomes after transcatheter or surgical aortic-valve replacement.

    PubMed

    Kodali, Susheel K; Williams, Mathew R; Smith, Craig R; Svensson, Lars G; Webb, John G; Makkar, Raj R; Fontana, Gregory P; Dewey, Todd M; Thourani, Vinod H; Pichard, Augusto D; Fischbein, Michael; Szeto, Wilson Y; Lim, Scott; Greason, Kevin L; Teirstein, Paul S; Malaisrie, S Chris; Douglas, Pamela S; Hahn, Rebecca T; Whisenant, Brian; Zajarias, Alan; Wang, Duolao; Akin, Jodi J; Anderson, William N; Leon, Martin B

    2012-05-03

    The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits. At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation. The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001). A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).

  13. 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.

  14. Modern Use of Echocardiography in Transcatheter Aortic Valve Replacement: an Up-Date.

    PubMed

    Caldararu, Cristina; Balanescu, Serban

    2016-12-01

    Echocardiography is the cornerstone in the diagnosis of any valvular heart disease. The accurate diagnosis of aortic stenosis, the left ventricle function and the other heart valves evaluation are currently done by ultrasound alone. Prosthetic valve choice and dimensions prior to implantation can be done solely by proper use of echocardiography. The emergence of new methods to cure aortic stenosis such as trans-catheter aortic valve replacement (TAVR) emphasized the diagnostic value of cardiac ultrasound. The usefulness of echocardiography in TAVR can be divided in the baseline assessment (common to patients treated by conventional surgery), intra-procedural guidance of valve deployment and post-procedural follow-up. In the baseline diagnostic work-up echocardiography should allow proper assessment of low-gradient severe aortic stenosis and especially of "low-flow, low-gradient" aortic stenosis, as far the benefit of any valve intervention in these cases may be overshadowed by persistent ventricular dysfunction. "Classic" TAVR is performed with a trans-esophageal echocardiography probe in place, but recently intracardiac echocardiography (ICE) was advocated to reduce the need for general anesthesia. "Minimalist TAVR approach" recommends no echo-guidance and valve implantation by angiography alone. Post-TAVR echo assessment should allow prompt recognition of early complications and the severity of para-valvular leaks. Long term follow-up by echocardiography assesses prosthetic valve function, left ventricular functional recovery and the impact of the procedure on associated conditions (mitral regurgitation, pulmonary hypertension or tricuspid regurgitation). This article emphasizes the role of the cardiologist with ultrasound skills in the assessment of patients addressed to TAVR.

  15. 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.

  16. Comparison of transcatheter aortic valve and surgical bioprosthetic valve durability: A fatigue simulation study.

    PubMed

    Martin, Caitlin; Sun, Wei

    2015-09-18

    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. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. 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.

  18. Baseline HV-interval predicts complete AV-block secondary to transcatheter aortic valve implantation.

    PubMed

    Shin, Dong-In; Merx, Marc W; Meyer, Christian; Kirmanoglou, Kiriakos; Hellhammer, Katharina; Ohlig, Jan; Katsani, Dimitra; Zeus, Tobias; Westenfeld, Ralf; Eickholt, Christian; Linke, Axel; Kelm, Malte

    2015-10-01

    Development of AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). To date little is known about the predictive value of the HV-interval prior to TAVI with respect to the risk of AV-block development. HV-interval was determined in 25 consecutive elderly patients with severe aortic valve stenosis (AS) before and immediately after TAVI. All patients subsequently underwent TAVI and 8 of these 25 patients (32%) developed complete AV-block during the TAVI procedure requiring permanent pacemaker implantation. Six of these 8 patients (75%) had marked HV prolongation (>54 ms). Pre-procedural HV-interval was significantly prolonged in the subgroup developing complete AV-block (62.1 ms±13.0 vs 49.2 ms±12.9; P=0.029). Prolongation of the HV-interval above 54 ms was associated with a higher rate of complete AV-block (sensitivity 75.0%, specificity 77.8%, P=0.01). HV-interval was prolonged in approximately one third of our elderly patients with aortic valve stenosis and associated with a high rate of complete AV-block following TAVI. HV-interval is easily obtained during TAVI screening procedures, thus facilitating identification of patients at risk for complete AV-block due to TAVI and consequently enabling bespoke risk management.

  19. Effect of Balloon-Expandable Transcatheter Aortic Valve Replacement Positioning: A Patient-Specific Numerical Model.

    PubMed

    Bianchi, Matteo; Marom, Gil; Ghosh, Ram P; Fernandez, Harold A; Taylor, James R; Slepian, Marvin J; Bluestein, Danny

    2016-12-01

    Transcatheter aortic valve replacement (TAVR) has emerged as a life-saving and effective alternative to surgical valve replacement in high-risk, elderly patients with severe calcific aortic stenosis. Despite its early promise, certain limitations and adverse events, such as suboptimal placement and valve migration, have been reported. In the present study, it was aimed to evaluate the effect of various TAVR deployment locations on the procedural outcome by assessing the risk for valve migration. The deployment of a balloon-expandable Edwards SAPIEN valve was simulated via finite element analysis in a patient-specific calcified aortic root, which was reconstructed from CT scans of a retrospective case of valve migration. The deployment location was parametrized in three configurations and the anchorage was quantitatively assessed based on the contact between the stent and the native valve during the deployment and recoil phases. The proximal deployment led to lower contact area between the native leaflets and the stent which poses higher risk for valve migration. The distal and midway positions resulted in comparable outcomes, with the former providing a slightly better anchorage. The approach presented might be used as a predictive tool for procedural planning in order to prevent prosthesis migration and achieve better clinical outcomes.

  20. Evaluation of MRI issues at 3-Tesla for a transcatheter aortic valve replacement (TAVR) bioprosthesis.

    PubMed

    Saeedi, Mahrad; Thomas, Asish; Shellock, Frank G

    2015-05-01

    Replacement of the aortic heart valve typically requires open-heart surgery. A new transcatheter aortic valve replacement (TAVR) bioprosthesis made from metallic material was recently developed that is an advantageous alternative insofar as it is implanted using a minimally invasive procedure. Because of the presence of metal, there are safety issues related to MRI. Therefore, the purpose of this study was to use standardized testing techniques to evaluate MRI issues for this TAVR bioprosthesis in association with a 3-Tesla MR system. The TAVR bioprosthesis (Hydra Aortic Valve, Percutaneous Heart Valve Prosthesis, Vascular Innovations Company, Ltd, Thailand) was evaluated for magnetic field interactions (translational attraction and torque), MRI-related heating at a relative high specific absorption rate level (whole body average SAR, 2.9-W/kg), and artifacts (T1-weighted, spin echo, and gradient echo pulse sequences) at 3-Tesla. The TAVR bioprosthesis demonstrated negligible magnetic field interactions (deflection angle, 3-degrees; torque, 0) and minimal heating (maximum temperature rise, 2.5°C; background temperature rise, 1.7°C). Artifacts were relatively small in relation to the size and shape of the implant. The TAVR bioprosthesis that was evaluated in this investigation is acceptable, or using current MRI terminology "MR Conditional", for a patient undergoing MRI at 3-Tesla or less. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Valve: United Kingdom Experience.

    PubMed

    Rampat, Rajiv; Khawaja, M Zeeshan; 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

    2016-02-22

    This study sought to present the U.K. experience to date with the second-generation LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts). First-generation transcatheter aortic valves have limitations. Second-generation repositionable valves may improve on some of those limitations. Prospectively collected data relating to procedural and in-hospital outcome was analyzed from 10 implantation centers in the United Kingdom. Implants in 228 patients age 81.4 ± 7.6 years were studied; 53.5% were male. Mean logistic EuroScore was 17.5 ± 12.4. One hundred eighty-seven (82.0%) were undertaken for aortic stenosis, 7 (3.1%) for aortic regurgitation, and 34 (14.9%) for mixed aortic valve disease. A total of 67.1% of cases were done under local anesthetic and/or sedation with transfemoral access in 94.7% and transaortic in 5.3%. Three device sizes were used: 23 mm (n = 66, 28.9%), 25 mm (n = 39, 17.1%), and 27 mm (n = 123, 53.9%). The valve was successfully deployed in 99.1% of procedures. After implantation, the mean aortic gradient was 11.4 ± 5.4 mm Hg and aortic valve area 1.6 ± 0.5 cm(2). In-hospital mortality was 1.8% (n = 4). Complications included cardiac tamponade (1.8%), conversion to sternotomy (1.3%), stroke (3.9%), vascular access-related (7.0%), and acute kidney injury (7.9%). The incidence of moderate/severe aortic regurgitation was 0.8% (n = 2). A total of 31.8% of patients required new permanent pacemaker implantation. This analysis represents the largest published series on use of the LOTUS valve. Outcomes using this valve are excellent. In-hospital mortality is very low. Complication rates are low, and the LOTUS valve improves on first-generation valves, particularly with regard to residual aortic regurgitation. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  2. 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

  3. Cardiac rehabilitation programme after transcatheter aortic valve implantation versus surgical aortic valve replacement: Systematic review and meta-analysis.

    PubMed

    Ribeiro, Gustavo S; Melo, Rosangela D; Deresz, Luís F; Dal Lago, Pedro; Pontes, Mauro Rn; Karsten, Marlus

    2017-05-01

    Background Aortic stenosis is a valvular heart disease characterised by fixed obstruction of the left ventricular outflow. It can be managed by surgical aortic valve replacement (sAVR) or transcatheter aortic valve implantation (TAVI). This review aimed to describe the evidence supporting a cardiac rehabilitation programme on functional capacity and quality of life in aortic stenosis patients after sAVR or TAVI. Methods The search was conducted on multiple databases from January to March 2016. All studies were eligible that evaluated the effects of a post-interventional cardiac rehabilitation programme in aortic stenosis patients. The methodological quality was assessed using the PEDro scale. Meta-analysis was performed separately by procedure and between procedures. The walked distance during the six-minute walk test (6MWD) and Barthel index were evaluated. The analysis was conducted in Review Manager. Results Five studies were included (292 TAVI and 570 sAVR patients). The meta-analysis showed that a cardiac rehabilitation programme was associated with a significant improvement in 6MWD (0.69 (0.47, 0.91); P < 0.001) and Barthel index (0.80 (0.29, 1.30); P = 0.002) after TAVI and 6MWD (0.79 (0.43, 1.15); P < 0.001) and Barthel index (0.93 (0.67, 1.18); P < 0.001) after sAVR. In addition, the meta-analysis showed that the cardiac rehabilitation programme promoted a similar gain in 6MWD (4.28% (-12.73, 21.29); P = 0.62) and Barthel index (-1.52 points (-4.81, 1.76); P = 0.36) after sAVR or TAVI. Conclusions The cardiac rehabilitation programme improved the functional capacity and quality of life in aortic stenosis patients. Patients who underwent TAVI benefitted with a cardiac rehabilitation programme similar to sAVR patients.

  4. Impact of Ejection Fraction and Aortic Valve Gradient on Outcomes of Transcatheter Aortic Valve Replacement.

    PubMed

    Baron, Suzanne J; Arnold, Suzanne V; Herrmann, Howard C; Holmes, David R; Szeto, Wilson Y; Allen, Keith B; Chhatriwalla, Adnan K; Vemulapali, Sreekaanth; O'Brien, Sean; Dai, Dadi; Cohen, David J

    2016-05-24

    In patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), studies have suggested that reduced left ventricular (LV) ejection fraction (LVEF) and low aortic valve gradient (AVG) are associated with worse long-term outcomes. Because these conditions commonly coexist, the extent to which they are independently associated with outcomes after TAVR is unknown. The purpose of this study was to evaluate the impact of LVEF and AVG on clinical outcomes after TAVR and to determine whether the effect of AVG on outcomes is modified by LVEF. Using data from 11,292 patients who underwent TAVR as part of the Transcatheter Valve Therapies Registry, we examined rates of 1-year mortality and recurrent heart failure in patients with varying levels of LV dysfunction (LVEF <30% vs. 30% to 50% vs. >50%) and AVG (<40 mm Hg vs. ≥40 mm Hg). Multivariable models were used to estimate the independent effect of AVG and LVEF on outcomes. During the first year of follow-up after TAVR, patients with LV dysfunction and low AVG had higher rates of death and recurrent heart failure. After adjustment for other clinical factors, only low AVG was associated with higher mortality (hazard ratio: 1.21; 95% confidence interval: 1.11 to 1.32; p < 0.001) and higher rates of heart failure (hazard ratio: 1.52; 95% confidence interval: 1.36 to 1.69; p <0.001), whereas the effect of LVEF was no longer significant. There was no evidence of effect modification between AVG and LVEF with respect to either endpoint. In this series of real-world patients undergoing TAVR, low AVG, but not LV dysfunction, was associated with higher rates of mortality and recurrent heart failure. Although these findings suggest that AVG should be considered when evaluating the risks and benefits of TAVR for individual patients, neither severe LV dysfunction nor low AVG alone or in combination provide sufficient prognostic discrimination to preclude treatment with TAVR. Copyright © 2016 American

  5. Transapical transcatheter aortic valve implantation using the J-Valve system: A 1-year follow-up study.

    PubMed

    Luo, Xiang; Wang, Xu; Li, Xuan; Wang, Xin; Xu, Fei; Liu, Mingzheng; Yu, Bing; Li, Fei; Tong, Minghui; Wang, Wei

    2017-07-01

    Transcatheter aortic valve implantation has become a routine procedure to treat screened inoperable or high-risk patients. In this study, we present the first outcome of echocardiographic midterm using a new second-generation transcatheter aortic valve implantation system, the J-Valve system (Jie Cheng Medical Technologies, Suzhou, China), in patients with aortic stenosis or aortic regurgitation. From July 2014 to June 2015, 21 patients with isolated aortic valve disease at high risk for open surgery received transapical transcatheter aortic valve implantation using the J-Valve system. The primary end point was a combined efficacy end point after 1 year, which included all-cause mortality after more than 30 days and failure of current therapy for aortic stenosis or aortic regurgitation requiring hospitalization for symptoms of valve-related cardiac decompensation or prosthetic heart valve dysfunction. Secondary end points were cardiovascular mortality, major stroke, and life-threatening, disabling, or major bleeding after 6 and 12 months. The mean age of the study cohort was 75.52 ± 5.22 years, the European System for Cardiac Operative Risk Evaluation II score was 11.33% ± 1.28%, and the mean logistic European System for Cardiac Operative Risk Evaluation I score was 31.13% ± 9.68%. Transcatheter aortic valve implantation with the J-Valve system was successfully performed in 19 of the 21 patients (90.5%). For patients with aortic stenosis, 12-month follow-up echocardiography demonstrated an increase in mean effective valve area from 0.62 ± 0.17 cm(2) to 1.52 ± 0.35 cm(2) and a decrease in transvalvular mean gradient from 61 ± 15 mm Hg to 18 ± 9 mm Hg. All surviving patients (n = 18) reported improvements in at least 1 of the New York Heart Association classes. The combined ratio of successful implantation and absence of adverse events in our cohort (n = 21) was 76.19%. The J-Valve system exhibits a convincing midterm performance and

  6. Transcaval Access and Closure for Transcatheter Aortic Valve Replacement: A Prospective Investigation.

    PubMed

    Greenbaum, Adam B; Babaliaros, Vasilis C; Chen, Marcus Y; Stine, Annette M; Rogers, Toby; O'Neill, William W; Paone, Gaetano; Thourani, Vinod H; Muhammad, Kamran I; Leonardi, Robert A; Ramee, Stephen; Troendle, James F; Lederman, Robert J

    2017-02-07

    Transcaval access may enable fully percutaneous transcatheter aortic valve replacement (TAVR) without the hazards and discomfort of transthoracic (transapical or transaortic) access. The authors performed a prospective, independently adjudicated, multicenter, single-arm trial of transcaval access for TAVR in patients who were ineligible for femoral artery access and had high or prohibitive risk of complications from transthoracic access. A total of 100 patients underwent attempted percutaneous transcaval access to the abdominal aorta by electrifying a caval guidewire and advancing it into a pre-positioned aortic snare. After exchanging for a rigid guidewire, conventional TAVR was performed through transcaval introducer sheaths. Transcaval access ports were closed with nitinol cardiac occluders. A core laboratory analyzed pre-discharge and 30-day abdominal computed tomograms. The Society of Thoracic Surgeons predicted risk of mortality was 9.6 ± 6.3%. Transcaval access was successful in 99 of 100 patients. Device success (access and closure with a nitinol cardiac occluder without death or emergency surgical rescue) occurred 98 of 99 patients; 1 subject had closure with a covered stent. Inpatient survival was 96%, and 30-day survival was 92%. Second Valve Academic Research Consortium (VARC-2) life-threatening bleeding and modified VARC-2 major vascular complications possibly related to transcaval access were 7% and 13%, respectively. Median length of stay was 4 days (range 2 to 6 days). There were no vascular complications after discharge. Transcaval access enabled TAVR in patients who were not good candidates for transthoracic access. Bleeding and vascular complications, using permeable nitinol cardiac occluders to close the access ports, were common but acceptable in this high-risk cohort. Transcaval access should be investigated in patients who are eligible for transthoracic access. Purpose-built closure devices are in development that may simplify the

  7. Drivers of healthcare costs associated with the episode of care for surgical aortic valve replacement versus transcatheter aortic valve implantation

    PubMed Central

    Wijeysundera, Harindra C; Li, Lindsay; Braga, Vevien; Pazhaniappan, Nandhaa; Pardhan, Anar M; Lian, Dana; Leeksma, Aric; Peterson, Ben; Cohen, Eric A; Forsey, Anne; Kingsbury, Kori J

    2016-01-01

    Objective Transcatheter aortic valve implantation (TAVI) is generally more expensive than surgical aortic valve replacement (SAVR) due to the high cost of the device. Our objective was to understand the patient and procedural drivers of cumulative healthcare costs during the index hospitalisation for these procedures. Design All patients undergoing TAVI, isolated SAVR or combined SAVR+coronary artery bypass grafting (CABG) at 7 hospitals in Ontario, Canada were identified during the fiscal year 2012–2013. Data were obtained from a prospective registry. Cumulative healthcare costs during the episode of care were determined using microcosting. To identify drivers of healthcare costs, multivariable hierarchical generalised linear models with a logarithmic link and γ distribution were developed for TAVI, SAVR and SAVR+CABG separately. Results Our cohort consisted of 1310 patients with aortic stenosis, of whom 585 underwent isolated SAVR, 518 had SAVR+CABG and 207 underwent TAVI. The median costs for the index hospitalisation for isolated SAVR were $21 811 (IQR $18 148–$30 498), while those for SAVR+CABG were $27 256 (IQR $21 741–$39 000), compared with $42 742 (IQR $37 295–$56 196) for TAVI. For SAVR, the major patient-level drivers of costs were age >75 years, renal dysfunction and active endocarditis. For TAVI, chronic lung disease was a major patient-level driver. Procedural drivers of cost for TAVI included a non-transfemoral approach. A prolonged intensive care unit stay was associated with increased costs for all procedures. Conclusions We found wide variation in healthcare costs for SAVR compared with TAVI, with different patient-level drivers as well as potentially modifiable procedural factors. These highlight areas of further study to optimise healthcare delivery. PMID:27621832

  8. 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.).

  9. Transcatheter aortic valve implantation (TAVI) versus sutureless aortic valve replacement (SUAVR) for aortic stenosis: a systematic review and meta-analysis of matched studies

    PubMed Central

    Tsai, Yi-Chin; Niles, Natasha; Tchantchaleishvili, Vakhtang; Di Eusanio, Marco; Yan, Tristan D.; Phan, Kevin

    2016-01-01

    Background With improving technologies and an increasingly elderly populations, there have been an increasing number of therapeutic options available for patients requiring aortic valve replacement. Recent evidence suggests that transcatheter aortic valve implantation (TAVI) is one suitable option for high risk inoperable patients, as well as high risk operable patients. Sutureless valve technology has also been developed concurrently, with facilitates surgical aortic valve replacement (SUAVR) by allow resection and replacement of the native aortic valve with minimal sutures and prosthesis anchoring required. For patients amenable for both TAVI and SUAVR, the evidence is unclear with regards to the benefits and risks of either approach. The objectives are to compare the perioperative outcomes and intermediate-term survival rates of TAVI and SUAVR in matched or propensity score matched studies. Methods A systematic literature search was performed to include all matched or propensity score matched studies comparing SUAVR versus TAVI for severe aortic stenosis. A meta-analysis with odds ratios (OR) and mean differences were performed to compare key outcomes including paravalvular regurgitation and short and intermediate term mortality. Results Six studies met our inclusion criteria giving a total of 741 patients in both the SUAVR and TAVI arm of the study. Compared to TAVI, SUAVR had a lower incidence of paravalvular leak (OR =0.06; 95% CI: 0.03–0.12, P<0.01). There was no difference in perioperative mortality, however SUAVR patients had significantly better survival rates at 1 (OR =2.40; 95% CI: 1.40–4.11, P<0.01) and 2 years (OR =4.62; 95% CI: 2.62–8.12, P<0.01). Conclusions The present study supports the use of minimally invasive SUAVR as an alternative to TAVI in high risk patients requiring aortic replacement. The presented results require further validation in prospective, randomized controlled studies. PMID:28066608

  10. 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

  11. 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

  12. Effect of Hospital Volume on Outcomes of Transcatheter Aortic Valve Implantation.

    PubMed

    Badheka, Apurva O; Patel, Nileshkumar J; Panaich, Sidakpal S; Patel, Samir V; Jhamnani, Sunny; Singh, Vikas; Pant, Sadip; Patel, Nish; Patel, Nilay; Arora, Shilpkumar; Thakkar, Badal; Manvar, Sohilkumar; Dhoble, Abhijeet; Patel, Achint; Savani, Chirag; Patel, Jay; Chothani, Ankit; Savani, Ghanshyambhai T; Deshmukh, Abhishek; Grines, Cindy L; Curtis, Jeptha; Mangi, Abeel A; Cleman, Michael; Forrest, John K

    2015-08-15

    Transcatheter aortic valve implantation (TAVI) is associated with a significant learning curve. There is paucity of data regarding the effect of hospital volume on outcomes after TAVI. This is a cross-sectional study based on Healthcare Cost and Utilization Project's Nationwide Inpatient Sample database of 2012. Subjects were identified by International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes, 35.05 (Trans-femoral/Trans-aortic Replacement of Aortic Valve) and 35.06 (Trans-apical Replacement of Aortic Valve). Annual hospital TAVI volumes were calculated using unique identification numbers and then divided into quartiles. Multivariate logistic regression models were created. The primary outcome was inhospital mortality; secondary outcome was a composite of inhospital mortality and periprocedural complications. Length of stay (LOS) and cost of hospitalization were assessed. The study included 1,481 TAVIs (weighted n = 7,405). Overall inhospital mortality rate was 5.1%, postprocedural complication rate was 43.4%, median LOS was 6 days, and median cost of hospitalization was $51,975. Inhospital mortality rates decreased with increasing hospital TAVI volume with a rate of 6.4% for lowest volume hospitals (first quartile), 5.9% (second quartile), 5.2% (third quartile), and 2.8% for the highest volume TAVI hospitals (fourth quartile). Complication rates were significantly higher in hospitals with the lowest volume quartile (48.5%) compared to hospitals in the second (44.2%), third (39.7%), and fourth (41.5%) quartiles (p <0.001). Increasing hospital volume was independently predictive of shorter LOS and lower hospitalization costs. In conclusion, higher annual hospital volumes are significantly predictive of reduced postprocedural mortality, complications, shorter LOS, and lower hospitalization costs after TAVI.

  13. Three-year outcomes after transcatheter aortic valve implantation with the CoreValve prosthesis.

    PubMed

    Gotzmann, Michael; Czauderna, Anna; Hehnen, Tobias; Aweimer, Assem; Lind, Alexander; Kloppe, Axel; Bösche, Leif; Mügge, Andreas; Ewers, Aydan

    2014-08-15

    There is little known about the long-term results of the CoreValve prosthesis. The aim of this study was to assess the 3-year clinical and hemodynamic outcomes of the CoreValve prosthesis. One hundred fifty consecutive patients with severe aortic stenosis successfully underwent transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis. The primary study end point was death from any cause after TAVI. The secondary end points were defined as (1) cardiovascular death and (2) prosthesis-related mortality and morbidity. At 1 to 3 years, all-cause mortality rates were 25%, 32%, and 41%, respectively, and cardiovascular mortality rates were 14%, 21%, and 27%, respectively. Before TAVI, 95% of patients were in New York Heart Association class III or IV. Of the surviving patients, rates of New York Heart Association class III or IV at 1 to 3 years were 33%, 39%, and 38%, respectively. There was an annual decrease of the valve area of approximately 0.1 cm². Aortic restenosis occurred in 2 patients. Moderate or severe aortic regurgitation (AR) occurred in 15% of patients immediately after TAVI. Twenty patients (13%) had a slight worsening of AR within 3 years. New severe AR did not occur. The incidence of prosthesis-related endocarditis was 0.66% per year. Overall, 7 patients (incidence of 1.5% per year) had a clinically relevant problem of the prosthesis. In conclusion, TAVI with the CoreValve prosthesis had favorable effects on symptoms and outcomes even after 3 years. These results are clouded by side effects, such as AR and prosthesis-related mortality and morbidity.

  14. Transcatheter aortic valve replacement: transapical resection of the aortic valve in vivo.

    PubMed

    Bombien Quaden, René; Leester-Schaedel, Monika; Lozonschi, Lucian; Lutter, Georg

    2012-09-01

    The resection of pulmonary valves has already been demonstrated in an experimental beating-heart model. The aim of this study was to analyse the transapical laser-assisted resection of aortic valves in an in vivo porcine model in a non-beating heart. The resection was performed in a porcine model (n = 10) using a Thullium:YAG laser. After establishing a standard extracorporeal circulatory support, the aortic valve isolation chamber (AVIC) system was inserted transapically. The resection of the aortic leaflets was carried out step-by-step in the arrested heart. The AVIC implantation, the resection process, and the gross anatomy of intracardiac lesions were analysed. The procedure for installing the AVIC took 5.8 ± 1.5 min. A sealed chamber was achieved in 9/10 cases. The resection of the valves was performed in 8/10 and completed in 7/10 cases. The resection took, on average, 7.4 ± 2.7 min/cusp. In 9/10 cases, the sealing was sufficient. Gross anatomy and histological analysis demonstrated only superficial damage to the surrounding tissue. In this study, the in vivo on-pump isolation of the left ventricular outflow tract and the laser resection of the native aortic valve could be demonstrated successfully. Nevertheless, this model is the next step towards a beating-heart resection of the aortic valve using the isolation chamber.

  15. 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

  16. Retrograde Snare Technique to Overcome Hostile Aortic Arch Anatomy During Transcatheter Aortic Valve Implantation.

    PubMed

    De Palma, Rodney; Saleh, Nawsad; Ruck, Andreas; Settergren, Magnus

    2016-07-01

    Percutaneous valve implantation is a recognized therapy for calcific aortic stenosis in those patients who are inoperable or at high surgical risk. The transfemoral approach is the most frequently used method for device delivery, but a tortuous calcific aorta and the inflexibility of large-caliber endovascular equipment can impede progress or even cause the procedure to be abandoned. Herein, the use of a technique employing a snare to safely overcome device obstruction in the aortic arch of an elderly female patient is described. The technique may be of practical value whenever any large-caliber device is obstructed in the circulation.

  17. Comparison of transcatheter aortic valve replacement risk score against currently accepted surgical risk models as predictors of 30-day mortality in transcatheter aortic valve replacement.

    PubMed

    Yatsynovich, Yan; Khattak, Himad; Ali, Mohammed; Schwartz, Brian; Pak, Stella; Chen, Tian

    2017-09-20

    Aim of the study was to assess the predictive capability of Transcatheter Aortic Valve Replacement Risk Score (TAVR-RS) in comparison with Society of Thoracic Surgeon-Predicted Risk of Mortality (STS PROM) and European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) on 30-day mortality following TAVR. With exponentially increasing use of TAVR, a risk stratification model to accurately predict mortality risks in patients undergoing TAVR is urgently warranted. Retrospective analysis of 182 TAVRs between 2014 and 2017, 179 by transfemoral, 3 by subclavian approach. Clinical, laboratory and echocardiography variables were collected. The performance of risk models was evaluated using equivalence tests, receiver operating characteristic (ROC) and area under the ROC curve (AUC). Outcome was 30-day mortality prediction. Observed 30-day mortality was 5.49%. TAVR-RS underestimated (4.0%) while surgical models (STS PROM and EuroSCORE II) overestimated mortality, 7.24% and 8.14%, respectively. The TAVR-RS was found to have statistically significant correlation with both individual and group mortalities. AUC was highest for TAVR-RS 0.66 (95%CI: 0.31-0.96), but no difference in 30-day mortality prediction was found in comparison with STS PROM (P = 0.06) or EuroSCORE II (P = 0.2161). The TAVR-RS was a better predictor of both group and individual mortality at 30 days. The outcomes were comparable on pairwise testing against surgical risk models, although TAVR-RS was on verge of significance when compared to STS PROM. This study supports the current dogma that a risk model specifically tailored for TAVR population should be implemented to obtain a better patient selection. © 2017, Wiley Periodicals, Inc.

  18. TAVI or No TAVI: identifying patients unlikely to benefit from transcatheter aortic valve implantation.

    PubMed

    Puri, Rishi; Iung, Bernard; Cohen, David J; Rodés-Cabau, Josep

    2016-07-21

    Transcatheter aortic valve implantation (TAVI) has spawned the evolution of novel catheter-based therapies for a variety of cardiovascular conditions. Newer device iterations are delivering lower peri- and early post-procedural complication rates in patients with aortic stenosis, who were otherwise deemed too high risk for conventional surgical valve replacement. Yet beyond the post-procedural period, a considerable portion of current TAVI recipients fail to derive a benefit from TAVI, either dying or displaying a lack of clinical and functional improvement. Considerable interest now lies in better identifying factors likely to predict futility post-TAVI. Implicit in this are the critical roles of frailty, disability, and a multimorbidity patient assessment. In this review, we outline the roles that a variety of medical comorbidities play in determining futile post-TAVI outcomes, including the critical role of frailty underlying the identification of patients unlikely to benefit from TAVI. We discuss various TAVI risk scores, and further propose that by combining such scores along with frailty parameters and the presence of specific organ failure, a more accurate and holistic assessment of potential TAVI-related futility could be achieved.

  19. Suture Forces for Closure of Transapical Transcatheter Aortic Valve Replacement: A Mathematical Model.

    PubMed

    Ge, Liang; Haraldsson, Henrik; Hope, Michael D; Saloner, David; Guccione, Julius M; Ratcliffe, Mark B; Tseng, Elaine E

    2016-07-01

    Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of severe aortic stenosis in intermediate, high-risk, and inoperable patients. TAVR has multiple access routes, including transfemoral (TF), transapical (TA), direct aortic (DA), axillary, transcarotid, and transcaval. The most commonly applied algorithm is a TF-first approach, where only when patients are unsuitable for TF are alternatives such as TA considered. An infrequent - but dreaded - risk is left ventricular (LV) apical bleeding from tearing or rupture with the TA approach. With burgeoning transcatheter mitral technology that requires a TA approach, the study aim was to develop a mathematical model to determine suture forces for TA closure. Preoperative cine-cardiac magnetic resonance imaging (MRI) was used to acquire three-dimensional (3D) LV geometry at end-systole and end-diastole. Endocardial and epicardial boundaries were manually contoured using MeVisLab, a surface reconstruction software. 3D surfaces of endocardium and epicardium were reconstructed, and surfaces at end-systole were used to create a 3D LV finite element (FE) mesh. TA access was mimicked by developing a 10-mm defect within the LV FE model. The LV apex was closed using a virtual suture technique in FE analysis with the application of two virtual sutures. After virtual closure, a FE analysis was performed of LV model diastolic filling and systolic contraction. Proof of concept was achieved to develop an LV transapical access site and perform FE analysis to achieve closure. The FE method of virtual suture technique successfully approximated the LV apical defect. The peak axial forces on virtual sutures at end-diastole and end-systole were 0.445N and 0.736N, respectively. A LV TA access model was mathematically developed that could be used to evaluate the suture tension of the TA closure process. Further development of this approach may be useful to risk-stratify patients in the future for LV apical tearing

  20. 5-Year Outcomes After Transcatheter Aortic Valve Implantation With CoreValve Prosthesis.

    PubMed

    Barbanti, Marco; Petronio, Anna Sonia; Ettori, Federica; Latib, Azeem; Bedogni, Francesco; De Marco, Federico; Poli, Arnaldo; Boschetti, Carla; De Carlo, Marco; Fiorina, Claudia; Colombo, Antonio; Brambilla, Nedy; Bruschi, Giuseppe; Martina, Paola; Pandolfi, Claudia; Giannini, Cristina; Curello, Salvatore; Sgroi, Carmelo; Gulino, Simona; Patanè, Martina; Ohno, Yohei; Tamburino, Claudia; Attizzani, Guilherme F; Immè, Sebastiano; Gentili, Alessandra; Tamburino, Corrado

    2015-07-01

    The purpose of this analysis was to assess 5-year outcomes of transcatheter aortic valve implantation (TAVI) using the current technology of the self-expanding CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota). There is a paucity of evidence on long-term durability of currently available transcatheter heart valves. Starting in June 2007, all consecutive patients with severe aortic stenosis undergoing TAVI with the third-generation 18-F CoreValve device in 8 Italian centers were prospectively included in the ClinicalService Project. For the purposes of this study, we included only consecutive patients with 5-year follow-up data available (n = 353) treated from June 2007 to August 2009. All outcomes were reported according to VARC (Valve Academic Research Consortium)-1 criteria. All-cause mortality rates at 1, 2, 3, 4, and 5 years were 21%, 29%, 38%, 48%, and 55.0%, respectively. Cardiovascular mortality rates at 1, 2, 3, 4, and 5 years were 10%, 14%, 19%, 23%, and 28.0%, respectively. The overall neurological event rate at 5 years was 7.5%, of which more than two-thirds occurred early after the procedure. During follow-up, there were 241 rehospitalizations for cardiovascular reasons in 164 (46%) patients. Among all rehospitalizations, acute heart failure was the most frequently reported (42.7%), followed by requirement of permanent pacemaker implantation (17.4%). On echocardiography, mean transaortic gradients decreased from 55.6 ± 16.8 mm Hg (pre-TAVI) to 12.8 ± 10.9 mm Hg (5-year post-TAVI) (p < 0.001). Late prosthesis failure occurred in 5 cases (1.4%); among these, redo TAVI was successfully carried out in 2 patients (0.6%) presenting with symptomatic prosthesis restenosis. The remaining 3 cases of prosthesis failure did not undergo further invasive interventions. Ten patients (2.8%) showed late mild stenosis with a mean transaortic gradient ranging from 20 to 40 mm Hg. No other cases of structural or nonstructural valvular deterioration were

  1. 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

  2. Transcatheter Versus Surgical Aortic Valve Replacement: Propensity-Matched Comparison.

    PubMed

    Brennan, J Matthew; Thomas, Laine; Cohen, David J; Shahian, David; Wang, Alice; Mack, Michael J; Holmes, David R; Edwards, Fred H; Frankel, Naftali Z; Baron, Suzanne J; Carroll, John; Thourani, Vinod; Tuzcu, E Murat; Arnold, Suzanne V; Cohn, Roberta; Maser, Todd; Schawe, Brenda; Strong, Susan; Stickfort, Allen; Patrick-Lake, Elizabeth; Graham, Felicia L; Dai, Dadi; Li, Fan; Matsouaka, Roland A; O'Brien, Sean; Li, Fan; Pencina, Michael J; Peterson, Eric D

    2017-07-25

    Randomized trials support the use of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis in high- and intermediate-risk patients, but the generalizability of those results in clinical practice has been challenged. The aim of this study was to determine the safety and effectiveness of TAVR versus surgical aortic valve replacement (SAVR), particularly in intermediate- and high-risk patients, in a nationally representative real-world cohort. Using data from the Transcatheter Valve Therapy Registry and Society of Thoracic Surgeons National Database linked to Medicare administrative claims for follow-up, 9,464 propensity-matched intermediate- and high-risk (Society of Thoracic Surgeons Predicted Risk of Mortality score ≥3%) U.S. patients who underwent commercial TAVR or SAVR were examined. Death, stroke, and days alive and out of the hospital to 1 year were compared, as well as discharge home, with subgroup analyses by surgical risk, demographics, and comorbidities. In a propensity-matched cohort (median age 82 years, 48% women, median Society of Thoracic Surgeons Predicted Risk of Mortality score 5.6%), TAVR and SAVR patients experienced no difference in 1-year rates of death (17.3% vs. 17.9%; hazard ratio: 0.93; 95% confidence interval [CI]: 0.83 to 1.04) and stroke (4.2% vs. 3.3%; hazard ratio: 1.18; 95% CI: 0.95 to 1.47), and no difference was observed in the proportion of days alive and out of the hospital to 1 year (rate ratio: 1.00; 95% CI: 0.98 to 1.02). However, TAVR patients were more likely to be discharged home after treatment (69.9% vs. 41.2%; odds ratio: 3.19; 95% CI: 2.84 to 3.58). Results were consistent across most subgroups, including among intermediate- and high-risk patients. Among unselected intermediate- and high-risk patients, TAVR and SAVR resulted in similar rates of death, stroke, and DAOH to 1 year, but TAVR patients were more likely to be discharged home. Copyright © 2017 American College of Cardiology

  3. Transcatheter Aortic Valve Implantation and Morbidity and Mortality-Related Factors: a 5-Year Experience in Brazil.

    PubMed

    Souza, André Luiz Silveira; Salgado, Constantino González; Mourilhe-Rocha, Ricardo; Mesquita, Evandro Tinoco; Lima, Luciana Cristina Lima Correia; Mattos, Nelson Durval Ferreira Gomes de; Rabischoffsky, Arnaldo; Fagundes, Francisco Eduardo Sampaio; Colafranceschi, Alexandre Siciliano; Carvalho, Luiz Antonio Ferreira

    2016-06-01

    Transcatheter aortic valve implantation has become an option for high-surgical-risk patients with aortic valve disease. To evaluate the in-hospital and one-year follow-up outcomes of transcatheter aortic valve implantation. Prospective cohort study of transcatheter aortic valve implantation cases from July 2009 to February 2015. Analysis of clinical and procedural variables, correlating them with in-hospital and one-year mortality. A total of 136 patients with a mean age of 83 years (80-87) underwent heart valve implantation; of these, 49% were women, 131 (96.3%) had aortic stenosis, one (0.7%) had aortic regurgitation and four (2.9%) had prosthetic valve dysfunction. NYHA functional class was III or IV in 129 cases (94.8%). The baseline orifice area was 0.67 ± 0.17 cm2 and the mean left ventricular-aortic pressure gradient was 47.3±18.2 mmHg, with an STS score of 9.3% (4.8%-22.3%). The prostheses implanted were self-expanding in 97% of cases. Perioperative mortality was 1.5%; 30-day mortality, 5.9%; in-hospital mortality, 8.1%; and one-year mortality, 15.5%. Blood transfusion (relative risk of 54; p = 0.0003) and pulmonary arterial hypertension (relative risk of 5.3; p = 0.036) were predictive of in-hospital mortality. Peak C-reactive protein (relative risk of 1.8; p = 0.013) and blood transfusion (relative risk of 8.3; p = 0.0009) were predictive of 1-year mortality. At 30 days, 97% of patients were in NYHA functional class I/II; at one year, this figure reached 96%. Transcatheter aortic valve implantation was performed with a high success rate and low mortality. Blood transfusion was associated with higher in-hospital and one-year mortality. Peak C-reactive protein was associated with one-year mortality.

  4. Transcatheter Aortic Valve Implantation and Morbidity and Mortality-Related Factors: a 5-Year Experience in Brazil

    PubMed Central

    Souza, André Luiz Silveira; Salgado, Constantino González; Mourilhe-Rocha, Ricardo; Mesquita, Evandro Tinoco; Lima, Luciana Cristina Lima Correia; de Mattos, Nelson Durval Ferreira Gomes; Rabischoffsky, Arnaldo; Fagundes, Francisco Eduardo Sampaio; Colafranceschi, Alexandre Siciliano; Carvalho, Luiz Antonio Ferreira

    2016-01-01

    Background Transcatheter aortic valve implantation has become an option for high-surgical-risk patients with aortic valve disease. Objective To evaluate the in-hospital and one-year follow-up outcomes of transcatheter aortic valve implantation. Methods Prospective cohort study of transcatheter aortic valve implantation cases from July 2009 to February 2015. Analysis of clinical and procedural variables, correlating them with in-hospital and one-year mortality. Results A total of 136 patients with a mean age of 83 years (80-87) underwent heart valve implantation; of these, 49% were women, 131 (96.3%) had aortic stenosis, one (0.7%) had aortic regurgitation and four (2.9%) had prosthetic valve dysfunction. NYHA functional class was III or IV in 129 cases (94.8%). The baseline orifice area was 0.67 ± 0.17 cm2 and the mean left ventricular-aortic pressure gradient was 47.3±18.2 mmHg, with an STS score of 9.3% (4.8%-22.3%). The prostheses implanted were self-expanding in 97% of cases. Perioperative mortality was 1.5%; 30-day mortality, 5.9%; in-hospital mortality, 8.1%; and one-year mortality, 15.5%. Blood transfusion (relative risk of 54; p = 0.0003) and pulmonary arterial hypertension (relative risk of 5.3; p = 0.036) were predictive of in-hospital mortality. Peak C-reactive protein (relative risk of 1.8; p = 0.013) and blood transfusion (relative risk of 8.3; p = 0.0009) were predictive of 1-year mortality. At 30 days, 97% of patients were in NYHA functional class I/II; at one year, this figure reached 96%. Conclusion Transcatheter aortic valve implantation was performed with a high success rate and low mortality. Blood transfusion was associated with higher in-hospital and one-year mortality. Peak C-reactive protein was associated with one-year mortality. PMID:27192383

  5. Transcatheter aortic valve implantation with the direct flow medical prosthesis: Impact of native aortic valve calcification degree on outcomes.

    PubMed

    D'Ancona, Giuseppe; Agma, Hüseyin U; Ince, Hüseyin; El-Achkar, Gihan; Dißmann, Martin; Ortak, Jasmin; Kische, Stephan

    2017-01-01

    We present our single center experience with the direct flow medical (DFM) prosthesis addressing the impact of native aortic valve (AV) calcification degree on outcomes. The DFM® has been introduced for transcatheter aortic valve implantation (TAVI). The valve has a nonmetallic and inflatable support structure. Patients were divided in two groups according to preoperative cardiac computed tomography (CT): group I moderate calcification and group II heavy calcification of the total AV area. We evaluated 118 patients: 53 (45%) group I and 65 (55%) group II. Preoperative trans-AV gradient and calcification extension across the aortic unit were significantly higher in group II (P = 0.008 and P < 0.0001). CT perimeter derived annular diameter (group I 24.7 ± 2.1 mm vs. group II 24.8 ± 1.9; P = 0.6) and implanted prosthesis size (group I 26.1 ± 1.5 mm vs. group II 25.7 ± 1.5; P = 0.1) were similar. Hemodynamics were similar: mean gradient 16.1 ± 5.9 mm Hg (group I) vs. 17.3 ± 6.5 mm Hg (group II) (P = 0.3). Total aortic regurgitation (AR) was mild in 5.7% in group I and 20% in group II (P = 0.03). None developed moderate/severe AR. Heavy AV calcification was the sole independent determinant for mild regurgitation (P = 0.02; OR = 7; 95% CI: 1.2-37.6). Follow-up (289 days; 40-760 days) estimated survival was 88.1% (group I) and 93.8% (group II) (P = 0.3). Independent of AV calcification degree, adequate sizing and implantation can be achieved with the DFM®. Although higher burden of calcification increases the rate of mild AR, no patient developed moderate and severe AR. Short-term estimated survival was not influenced by calcification degree. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  6. 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.

  7. Safety and efficacy of valve repositioning during transcatheter aortic valve replacement with the Lotus Valve System.

    PubMed

    Rashid, Hashrul N Z; Gooley, Robert; McCormick, Liam; Zaman, Sarah; Ramkumar, Satish; Jackson, Damon; Amiruddin, Ameera; Nasis, Arthur; Cameron, James; Meredith, Ian T

    2017-07-01

    To determine the safety and efficacy of valve repositioning following transcatheter aortic valve replacement (TAVR) with the Lotus Valve System (Boston Scientific, Marlborough, MA, USA). TAVR is a well-established treatment for severe aortic stenosis. The Lotus Valve System is fully repositionable and retrievable. Valve repositioning has the potential to minimize TAVR-related complications caused by valve malposition; however, the effect on adverse event rates such as stroke is unknown. Consecutive patients with severe aortic stenosis treated with the Lotus Valve System (n=125) were prospectively recruited. Patients who did not require valve repositioning (Group A) were compared to patients who required one or more valve repositions (Group B). The primary end-point was 30-day occurrence of major adverse cardiovascular and cerebrovascular events (MACCE). Secondary end-points included each component of the primary end-point, new pacemaker insertion, and procedural or 30-day major adverse events, defined according to VARC-2 definitions. Valve repositioning was utilized in 60.8% (76/125) of patients including 17.1% (13/76) who required full valve resheathing. The most frequent indications for valve repositioning were altering the depth and angulation of initial implantation (69.7%), reducing paravalvular regurgitation (13.2%), and attempt to correct new or worsened heart block (7.9%). Baseline characteristics were similar in both groups. The primary end-point occurred in 12.2% and 6.6% of Group A and B, respectively (p=0.10). Thirty-day new pacemaker implantation was 34.1% and 18.8% in Group A and B, respectively (p=0.06). The secondary end-point measures were not significantly different between the groups. Repositioning facilitated correct anatomical positioning of all devices leading to optimal prosthesis hemodynamics and a trend to lower pacemaker rate without increased risk of MACCE. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All

  8. Automatic Estimation of Optimal Deployment of Transcatheter Aortic Valve Implantation Using Computed Tomography.

    PubMed

    Kerner, Arthur; Abadi, Sobhi; Dotan, Roy; Javitt, Marcia; Aronson, Doron; Lessick, Jonathan

    2017-03-01

    A comparison was made between the accuracy of and time saved by using novel automated software for pre-procedural computed tomography (CT) planning before transcatheter aortic valve implantation (TAVI) and manual methods. Preprocedural CT to assess aortic annulus dimensions and predict the optimal C-arm implant angle before TAVI can reduce complications related to incorrect prosthesis sizing and positioning. A total of 61 consecutive patients underwent TAVI using either the SAPIEN XT or CoreValve prosthesis. Pre-procedural CT scans were analysed using three methods: automatic; semi-automatic; and manual. For each method, annular dimensions were measured and the optimal implantation angle was predicted. After TAVI the actual post-deployment angle orthogonal to the prosthesis was determined using aortic fluoroscopy. The difference between the predicted angle by CT and the measured post-deployment angle was calculated for each method. For all methods the mean angular difference with the actual post-deployment angle was similar at ~9 ± 7°. There was a significant difference between the SAPIEN XT (6.6 ± 5.8°) and CoreValve (11.5 ± 6.9°, p <0.001) prostheses due to a consistently greater left anterior oblique and caudal angulation for the CoreValve. Although the annular area correlated well among all methods, 'automatic' results were consistently larger than 'manual' results. Interobserver variability was low for all measures. The fully automatic method saved 98 s, and the semiautomatic method 40 s per case. The use of automatic software enabled a rapid and accurate prediction of implantation angles, though results differed for specific manufacturers. Annular areas were overestimated by the automatic method, and thus required manual adjustments.

  9. Transcatheter Aortic Valve Replacement in Women Versus Men (from the US CoreValve Trials).

    PubMed

    Forrest, John K; Adams, David H; Popma, Jeffrey J; Reardon, Michael J; Deeb, G Michael; Yakubov, Steven J; Hermiller, James B; Huang, Jian; Skelding, Kimberly A; Lansky, Alexandra

    2016-08-01

    Treatment for severe symptomatic aortic stenosis has changed significantly in recent years due to advances in transcatheter aortic valve replacement (TAVR). Recent studies with the CoreValve prosthesis have demonstrated superior results compared with surgical aortic valve replacement in patients at increased risk for surgery, but there are limited data on gender-related differences in patient characteristics and outcomes with this device. We compared baseline characteristics and clinical outcomes in women and men undergoing TAVR with the CoreValve prosthesis. A total of 3,687 patients (1,708 women and 1,979 men) were included. At baseline, women tended to be slightly older and to have increased frailty, but they had fewer cardiac co-morbidities, higher left ventricular systolic function, less coronary artery disease, and fewer previous strokes. All-cause mortality was 5.9% for women and 5.8% for men at 30 days (p = 0.87) and 24.1% and 21.3%, respectively, at 1 year (p = 0.08). The incidence of stroke was 5.7% in women and 4.0% in men at 30 days (p = 0.02) and 9.3% and 7.7%, respectively, at 1 year (p = 0.05). Women had a higher incidence of bleeding, including more life-threatening bleeds, and a greater incidence of major vascular complications than men at 30 days. Device success was achieved in 86.9% of women and 86.1% of men (p = 0.50). In conclusion, although there were significant baseline differences and procedure-related complications between women and men undergoing TAVR with the CoreValve prosthesis, this analysis found no significant difference in 30-day or 1-year mortality.

  10. Catheter manipulation analysis for objective performance and technical skills assessment in transcatheter aortic valve implantation.

    PubMed

    Mazomenos, Evangelos B; Chang, Ping-Lin; Rippel, Radoslaw A; Rolls, Alexander; Hawkes, David J; Bicknell, Colin D; Desjardins, Adrien; Riga, Celia V; Stoyanov, Danail

    2016-06-01

    Transcatheter aortic valve implantation (TAVI) demands precise and efficient handling of surgical instruments within the confines of the aortic anatomy. Operational performance and dexterous skills are critical for patient safety, and objective methods are assessed with a number of manipulation features, derived from the kinematic analysis of the catheter/guidewire in fluoroscopy video sequences. A silicon phantom model of a type I aortic arch was used for this study. Twelve endovascular surgeons, divided into two experience groups, experts ([Formula: see text]) and novices ([Formula: see text]), performed cannulation of the aorta, representative of valve placement in TAVI. Each participant completed two TAVI experiments, one with conventional catheters and one with the Magellan robotic platform. Video sequences of the fluoroscopic monitor were recorded for procedural processing. A semi-automated tracking software provided the 2D coordinates of the catheter/guidewire tip. In addition, the aorta phantom was segmented in the videos and the shape of the entire catheter was manually annotated in a subset of the available video frames using crowdsourcing. The TAVI procedure was divided into two stages, and various metrics, representative of the catheter's overall navigation as well as its relative movement to the vessel wall, were developed. Experts consistently exhibited lower values of procedure time and dimensionless jerk, and higher average speed and acceleration than novices. Robotic navigation resulted in increased average distance to the vessel wall in both groups, a surrogate measure of safety and reduced risk of embolisation. Discrimination of experience level and types of equipment was achieved with the generated motion features and established clustering algorithms. Evaluation of surgical skills is possible through the analysis of the catheter/guidewire motion pattern. The use of robotic endovascular platforms seems to enable more precise and controlled

  11. Atrioventricular Conduction Changes After CoreValve Transcatheter Aortic Valve Implantation.

    PubMed

    López-Aguilera, José; Segura Saint-Gerons, José María; Mazuelos Bellido, Francisco; Suárez de Lezo, Javier; Ojeda Pineda, Soledad; Pan Álvarez-Ossorio, Manuel; Romero Moreno, Miguel Ángel; Pavlovic, Djordje; Espejo Pérez, Simona; Suárez de Lezo, José

    2016-01-01

    Conduction disturbances often occur after CoreValve transcatheter aortic valve implantation. The aim was to analyze which cardiac conduction changes occur in patients with aortic stenosis treated with this type of prosthesis. A total of 181 patients with severe aortic stenosis treated with this prosthesis and studied by electrocardiography between April 2008 and December 2013 were selected. A subgroup of 137 (75.7%) consecutive patients was studied by intracardiac electrocardiogram before and after prosthesis implantation. The primary endpoint of the study was the need for a permanent pacemaker within 72 hours after prosthesis implantation. Numerous variables to predict this possibility were analyzed. Following implantation, PR and QRS intervals were increased from 173±47 ms to 190±52ms (P < .01) and from 98±22ms to 129±24 ms (P < .01), whereas the A-H and H-V intervals were prolonged from 95±39ms to 108±41ms (P < .01) and from 54±10ms to 66±23ms (P < .01). A total of 89 (49%) patients had new-onset left bundle-branch block, and 33 (25%) required a pacemaker within the first 72hours. The independent predictors for a pacemaker were baseline right bundle-branch block and prosthetic depth. Intracardiac intervals had no predictive value. In addition, 13 patients required a pacemaker after 72 hours. CoreValve prosthesis implantation has a high incidence of conduction disturbance, with left bundle-branch block being the most common. A total of 25% of patients required a permanent pacemaker. The need for a pacemaker was related to baseline right bundle-branch block and prosthetic depth. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  12. 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.

  13. 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.

  14. Efficacy and Safety of Transcatheter Aortic Valve Implantation for Bicuspid Aortic Valves: A Systematic Review and Meta-Analysis

    PubMed Central

    Xie, Xiaochuan; Shi, Xiaohan; Xun, Xiaoshuang

    2016-01-01

    Purpose: To elucidate the performance of transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients through a systematic review and meta-analysis. Methods: A systematic literature review was performed by searching eligible articles in PubMed, Medline, EMBASE, Google Scholar and CNKI. Meta-analysis of included case-control/cohort studies was further conducted. Relative risks (RRs) and the corresponding 95% confidence intervals (CIs) were used to compare clinical outcomes of BAV patients and non-BAV patients. Results: A total of 17 articles including eight case reports, four case series and five case-control/cohort studies with 166 BAV patients were analyzed. Device success rate achieved for TAVI in this cohort of BAV patients was 95.2%. The 30-day mortality rate was 8.4%, and the medium-term (range from 6 months to 2 years) mortality rate reported was 17.9%. Overall, the performance of TAVI in BAV patients was comparable to that in non-BAV patients, as reported by the included case-control/cohort studies (30-day mortality rate: RR = 1.05, 95%CI 0.57–1.95, p = 0.87; Device success rate: RR = 1.00, 95%CI 0.95–1.05, p = 0.94; Incidence of moderate to severe paravalvular regurgitation: RR = 1.25, 95%CI 0.85–1.84, p = 0.25). Conclusion: The present study suggested that TAVI may be a feasible and safe treatment modality for BAV patients. PMID:27098769

  15. Quality-of-life in elderly patients one year after transcatheter aortic valve implantation for severe aortic stenosis.

    PubMed

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

    2011-09-01

    Transcatheter aortic valve implantation (TAVI) is an emerging alternative to medical therapy reserved to a limited population with severe aortic stenosis. Quality-of-life (QoL) is a critical measure of effectiveness of TAVI in this patient population. In this prospective study, we sought to assess one year changes in QoL in patients who underwent TAVI. From June 2007 to July 2010, 149 consecutive patients underwent TAVI using the 18 Fr CoreValve (Medtronic Inc, Minneapolis, MN, USA) or the Edwards SAPIEN XT heart valve (Edwards Lifescience, Irvine, CA, USA) at our institution. Of these, 143 patients with successful prosthesis implantation comprised the study population. The SF-12v2 Health-Survey questionnaire provides scales for physical (physical component summary [PCS]) and mental (mental component summary [MCS]) health. Among patients included in the present analysis, device success was obtained in 138 patients (96.5%). Mean preprocedural SF-12v2 scores showed an important upgrading after TAVI: PCS improved from 28.3 to 44.0 at five months and 42.4 at 12 months (p<0.001). MCS increased from 38.0 to 47.3 at five months and 48.2 at 12 months (p<0.001). Both the physical and mental score summaries at follow-up of these post-TAVI patients were not significantly different from the anticipated thresholds of the general Italian population over the age of 75 years. NYHA functional class improvement was reported in all patients. Our results showed a marked mid-term improvement in functional status and physical and mental health in patients who underwent TAVI.

  16. 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.

  17. 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

  18. Technical Approach Determines Inflammatory Response after Surgical and Transcatheter Aortic Valve Replacement.

    PubMed

    Erdoes, Gabor; Lippuner, Christoph; Kocsis, Istvan; Schiff, Marcel; Stucki, Monika; Carrel, Thierry; Windecker, Stephan; Eberle, Balthasar; Stueber, Frank; Book, Malte

    2015-01-01

    To investigate the periprocedural inflammatory response in patients with isolated aortic valve stenosis undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) with different technical approaches. Patients were prospectively allocated to one of the following treatments: SAVR using conventional extracorporeal circulation (CECC, n = 47) or minimized extracorporeal circulation (MECC, n = 15), or TAVI using either transapical (TA, n = 15) or transfemoral (TF, n = 24) access. Exclusion criteria included infection, pre-procedural immunosuppressive or antibiotic drug therapy and emergency indications. We investigated interleukin (IL)-6, IL-8, IL-10, human leukocyte antigen (HLA-DR), white blood cell count, high-sensitivity C-reactive protein (hs-CRP) and soluble L-selectin (sCD62L) levels before the procedure and at 4, 24, and 48 h after aortic valve replacement. Data are presented for group interaction (p-values for inter-group comparison) as determined by the Greenhouse-Geisser correction. SAVR on CECC was associated with the highest levels of IL-8 and hs-CRP (p<0.017, and 0.007, respectively). SAVR on MECC showed the highest descent in levels of HLA-DR and sCD62L (both p<0.001) in the perioperative period. TA-TAVI showed increased intraprocedural concentration and the highest peak of IL-6 (p = 0.017). Significantly smaller changes in the inflammatory markers were observed in TF-TAVI. Surgical and interventional approaches to aortic valve replacement result in inflammatory modulation which differs according to the invasiveness of the procedure. As expected, extracorporeal circulation is associated with the most marked pro-inflammatory activation, whereas TF-TAVI emerges as the approach with the most attenuated inflammatory response. Factors such as the pre-treatment patient condition and the extent of myocardial injury also significantly affect inflammatory biomarker patterns. Accordingly, TA-TAVI is to be classified not as

  19. Intra-operative 2-D ultrasound and dynamic 3-D aortic model registration for magnetic navigation of transcatheter aortic valve implantation.

    PubMed

    Luo, Zhe; Cai, Junfeng; Peters, Terry M; Gu, Lixu

    2013-11-01

    We propose a navigation system for transcatheter aortic valve implantation that employs a magnetic tracking system (MTS) along with a dynamic aortic model and intra-operative ultrasound (US) images. This work is motivated by the desire of our cardiology and cardiac surgical colleagues to minimize or eliminate the use of radiation in the interventional suite or operating room. The dynamic 3-D aortic model is constructed from a preoperative 4-D computed tomography dataset that is animated in synchrony with the real time electrocardiograph input of patient, and then preoperative planning is performed to determine the target position of the aortic valve prosthesis. The contours of the aortic root are extracted automatically from short axis US images in real-time for registering the 2-D intra-operative US image to the preoperative dynamic aortic model. The augmented MTS guides the interventionist during positioning and deployment of the aortic valve prosthesis to the target. The results of the aortic root segmentation algorithm demonstrate an error of 0.92±0.85 mm with a computational time of 36.13±6.26 ms. The navigation approach was validated in porcine studies, yielding fiducial localization errors, target registration errors, deployment distance, and tilting errors of 3.02±0.39 mm, 3.31±1.55 mm, 3.23±0.94 mm, and 5.85±3.06(°) , respectively.

  20. Recovery of left ventricular mechanics after transcatheter aortic valve implantation: effects of baseline ventricular function and postprocedural aortic regurgitation.

    PubMed

    Poulin, Frédéric; Carasso, Shemy; Horlick, Eric M; Rakowski, Harry; Lim, Ki-Dong; Finn, Heather; Feindel, Christopher M; Greutmann, Matthias; Osten, Mark D; Cusimano, Robert J; Woo, Anna

    2014-11-01

    Impaired left ventricular (LV) myocardial deformation is associated with adverse outcome in patients with severe aortic stenosis (AS). The aim of this retrospective study was to assess the impact of transcatheter aortic valve implantation (TAVI) on the recovery of myocardial mechanics and the influence of postprocedural aortic regurgitation (AR). Speckle-tracking echocardiography was used to assess multidirectional myocardial deformation (longitudinal and circumferential strain) and rotational mechanics (apical rotation and twist) before and at midterm follow-up after TAVI. Predictors of myocardial recovery, defined as a ≥20% relative increase in the magnitude of global longitudinal strain compared with baseline, were examined. Sixty-four patients (median age, 83 years; interquartile range, 77-86 years) with severe AS and high surgical risk (mean European System for Cardiac Operative Risk Evaluation score, 20 ± 13%) were evaluated. Overall, LV longitudinal deformation was impaired at baseline compared with controls. At 5 ± 3 months after TAVI, LV longitudinal deformation had significantly improved only in the group of patients with baseline LV ejection fractions (LVEF) ≤ 55%: global longitudinal strain from -9.7 ± 3.7% to -11.8 ± 3.2% (P = .05), longitudinal strain rate from -0.44 ± 0.14 sec(-1) to -0.57 ± 0.16 sec(-1) (P = .001), and early diastolic strain rate from 0.38 ± 0.17 sec(-1) to 0.49 ± 0.18 sec(-1) (P = .01). In patients with normal LVEFs, LV twist was supraphysiologic at baseline and normalized after TAVI (from 16.1 ± 6.9° to 11.9 ± 6.2°, P = .004). In patients with baseline LVEFs ≤ 55%, circumferential deformation was impaired before TAVI and improved after TAVI. Baseline LVEF (odds ratio, 0.56 per 10% increment; P = .02) and global longitudinal strain (odds ratio, 0.65 per absolute 1% increment; P < .001) were significant predictors of myocardial recovery. LV mass, volumes, and longitudinal strain failed to favorably remodel in

  1. 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

  2. One-Year Clinical Outcomes With SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients With Severe Aortic Stenosis.

    PubMed

    Herrmann, Howard C; Thourani, Vinod H; Kodali, Susheel K; Makkar, Raj R; Szeto, Wilson Y; Anwaruddin, Saif; Desai, Nimesh; Lim, Scott; Malaisrie, S Chris; Kereiakes, Dean J; Ramee, Steven; Greason, Kevin L; Kapadia, Samir; Babaliaros, Vasilis; Hahn, Rebecca T; Pibarot, Philippe; Weissman, Neil J; Leipsic, Jonathon; Whisenant, Brian K; Webb, John G; Mack, Michael J; Leon, Martin B

    2016-07-12

    In the initial PARTNER trial (Placement of Aortic Transcatheter Valves) of transcatheter aortic valve replacement for high-risk (HR) and inoperable patients, mortality at 1 year was 24% in HR and 31% in inoperable patients. A recent report of the 30-day outcomes with the low-profile SAPIEN 3 transcatheter aortic valve replacement system demonstrated very low rates of adverse events, but little is known about the longer-term outcomes with this device. Between October 2013 and September 2014, 583 HR (65%) or inoperable (35%) patients were treated via the transfemoral (84%) or transapical/transaortic (16%) access route at 29 US sites. Major clinical events at 1 year were adjudicated by an independent clinical events committee, and echocardiographic results were analyzed by a core laboratory. Baseline characteristics included age of 83 years, 42% female, and median Society of Thoracic Surgeons score of 8.4%. At the 1-year follow-up, survival (all-cause) was 85.6% for all patients, 87.3% in the HR subgroup, and 82.3% in the inoperable subgroup. Survival free of all-cause and cardiovascular mortality in the transfemoral patients from the HR cohort was 87.7% and 93.3%, respectively. There was no severe paravalvular leak. Moderate paravalvular leak (2.7%) was associated with an increase in mortality at 1 year, whereas mild paravalvular leak had no significant association with mortality. Symptomatic improvement as assessed by the percentage of patients in New York Heart Association class III and IV (90.1% to 7.7% at 1 year; P<0.0001) and by Kansas City Cardiomyopathy Questionnaire overall summary score (improved from 46.9 to 72.4; P<0.0001) was marked. Multivariable predictors of 1-year mortality included alternative access, Society of Thoracic Surgeons score, and disabling stroke. In this large, adjudicated registry of SAPIEN 3 HR and inoperable patients, the very low rates of important complications resulted in a strikingly low mortality rate at 1 year. Between 30 and 365

  3. Transcatheter aortic valve implantation in patients with severe aortic valve stenosis and large aortic annulus, using the self-expanding 31-mm Medtronic CoreValve prosthesis: first clinical experience.

    PubMed

    Nijhoff, Freek; Agostoni, Pierfrancesco; Amrane, Hafid; Latib, Azeem; Testa, Luca; Oreglia, Jacopo A; De Marco, Federico; Samim, Mariam; Bedogni, Francesco; Maisano, Francesco; Bruschi, Giuseppe; Colombo, Antonio; Van Boven, Ad J; Stella, Pieter R

    2014-08-01

    With the introduction of the 31-mm Medtronic CoreValve prosthesis, patients with large aortic annulus have become eligible for transcatheter aortic valve implantation. The aim of this study was to evaluate the feasibility, efficacy, and safety of transcatheter aortic valve implantation using the 31-mm Medtronic CoreValve in patients with severe aortic valve stenosis and large aortic annulus. Five institutions in the Netherlands and Italy participated in a retrospective multicenter registry. Clinical, procedural, and imaging data of patients treated with the 31-mm Medtronic CoreValve were retrospectively collected in accordance with the Valve Academic Research Consortium-2 criteria. Between August 2011 and November 2012, 47 patients (44 men, mean age 77.6 ± 8.9 years) received the 31-mm Medtronic CoreValve prosthesis for severe aortic stenosis. Device success (correct positioning of a single valve with intended performance and no all-cause 30-day mortality) was achieved in 31 patients (66.0%). Reasons for failing the device success criteria were significant prosthetic aortic regurgitation in 3 patients (6.4%), second valve implantation in 10 patients (21.2%) (8 cases of malpositioning with high-grade aortic regurgitation, 1 acute valve dislocation, and 1 delayed valve dislocation), 1 of whom died intrahospital, and in-hospital mortality in a further 3 patients (6.4%). Peak and mean transaortic gradients decreased significantly (P < .01). The rate of new pacemaker implantations was 41.7%. In this retrospective multicenter registry, transcatheter treatment of severe aortic valve stenosis with the 31-mm Medtronic CoreValve seemed to be challenging, even in experienced hands. If the prosthesis is properly implanted, it offers adequate valve hemodynamics and proper functioning. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  4. Prosthetic Mitral Surgical Valve in Transcatheter Aortic Valve Replacement Recipients: A Multicenter Analysis.

    PubMed

    Amat-Santos, Ignacio J; Cortés, Carlos; Nombela Franco, Luis; Muñoz-García, Antonio J; Suárez De Lezo, Jose; Gutiérrez-Ibañes, Enrique; Serra, Vicenç; Larman, Mariano; Moreno, Raúl; De La Torre Hernandez, Jose M; Puri, Rishi; Jimenez-Quevedo, Pilar; Hernández García, José M; Alonso-Briales, Juan H; García, Bruno; Lee, Dae-Hyun; Rojas, Paol; Sevilla, Teresa; Goncalves, Renier; Vera, Silvio; Gómez, Itziar; Rodés-Cabau, Josep; San Román, José A

    2017-10-09

    The aim of this study was to determine the prognosis and specific complications of patients with prosthetic mitral valves (PMVs) undergoing transcatheter aortic valve replacement (TAVR). TAVR is performed relatively often in patients with PMVs, but specific risks are not well described. A multicenter analysis was conducted, including patients with severe symptomatic aortic stenosis who underwent TAVR at 10 centers. Patients' clinical characteristics and outcomes were evaluated according to the presence of a PMV. The mean age of the study population (n = 2,414) was 81 ± 8 years, and 48.8% were men. A total of 91 patients (3.77%) had PMVs. They were more commonly women, younger, and had higher surgical risk. PMVs were implanted a median of 14 years before TAVR, and most patients had mechanical prostheses (73.6%). Eighty-six patients (94.5%) were on long-term vitamin K inhibitor therapy, and bridging antithrombotic therapy was administered in 59 (64.8%). TAVR device embolization occurred in 6.7% (vs. 3.3% in the non-PMV group; p = 0.127), in all instances when distance between the PMV and the aortic annulus was <7 mm. Mortality rates did not show a difference, but the rate of bleeding was higher in patients with PMV (24.2% vs. 16.1%; p = 0.041), even in those treated via the transfemoral approach (22.2% vs. 13.9%; p = 0.048). Indeed, bleeding complications, prior atrial fibrillation, chronic obstructive pulmonary disease, surgical risk, and New York Heart Association functional class were independent predictors of mortality. TAVR presents similar mortality irrespective of the presence of a PMV. However, patients with PMVs had higher bleeding risk that was independently associated with higher mortality. Risk for valve embolization was relatively high, but it occurred only in patients with PMV-to-aortic annulus distances <7 mm. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  5. Midregional Proadrenomedullin Improves Risk Stratification beyond Surgical Risk Scores in Patients Undergoing Transcatheter Aortic Valve Replacement

    PubMed Central

    Schuetz, Philipp; Huber, Andreas; Müller, Beat; Maisano, Francesco; Taramasso, Maurizio; Moarof, Igal; Obeid, Slayman; Stähli, Barbara E.; Cahenzly, Martin; Binder, Ronald K.; Liebetrau, Christoph; Möllmann, Helge; Kim, Won-Keun; Hamm, Christian; Lüscher, Thomas F.

    2015-01-01

    Background Conventional surgical risk scores lack accuracy in risk stratification of patients undergoing transcatheter aortic valve replacement (TAVR). Elevated levels of midregional proadrenomedullin (MR-proADM) levels are associated with adverse outcome not only in patients with manifest chronic disease states, but also in the general population. Objectives We investigated the predictive value of MR-proADM for mortality in an unselected contemporary TAVR population. Methods We prospectively included 153 patients suffering from severe aortic stenosis who underwent TAVR from September 2013 to August 2014. This population was compared to an external validation cohort of 205 patients with severe aortic stenosis undergoing TAVR. The primary endpoint was all cause mortality. Results During a median follow-up of 258 days, 17 out of 153 patients who underwent TAVR died (11%). Patients with MR-proADM levels above the 75th percentile (≥ 1.3 nmol/l) had higher mortality (31% vs. 4%, HR 8.9, 95% CI 3.0–26.0, P < 0.01), whereas patients with EuroSCORE II scores above the 75th percentile (> 6.8) only showed a trend towards higher mortality (18% vs. 9%, HR 2.1, 95% CI 0.8–5.6, P = 0.13). The Harrell’s C-statistic was 0.58 (95% CI 0.45–0.82) for the EuroSCORE II, and consideration of baseline MR-proADM levels significantly improved discrimination (AUC = 0.84, 95% CI 0.71–0.92, P = 0.01). In bivariate analysis adjusted for EuroSCORE II, MR-proADM levels ≥1.3 nmol/l persisted as an independent predictor of mortality (HR 9.9, 95% CI (3.1–31.3), P <0.01) and improved the model’s net reclassification index (0.89, 95% CI (0.28–1.59). These results were confirmed in the independent validation cohort. Conclusions Our study identified MR-proADM as a novel predictor of mortality in patients undergoing TAVR. In the future, MR-proADM should be added to the commonly used EuroSCORE II for better risk stratification of patients suffering from severe aortic stenosis. PMID

  6. First-in-man transcatheter aortic valve implantation of a 20-mm Edwards SAPIEN XT valve: one step forward for the treatment of patients with severe aortic stenosis and small aortic annulus.

    PubMed

    Rodés-Cabau, Josep; DeLarochellière, Robert; Dumont, Eric

    2012-04-01

    We present the case of an 85-year-old woman diagnosed with severe aortic stenosis, porcelain aorta, and a small aortic annulus (17.3 mm), who underwent successful transfemoral transcatheter aortic valve implantation (TAVI) with a 20-mm Edwards SAPIEN XT valve using the NovaFlex+ delivery system. At 1-month follow-up the patient was in NYHA functional class I, and Doppler echocardiography showed a mean residual gradient of 15 mm Hg and trivial paravalvular aortic regurgitation. This case, which shows for the first time the feasibility of TAVI with a 20-mm valve, opens a new avenue for the challenging treatment of patients with aortic stenosis and a small aortic annulus.

  7. 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

  8. Reducing Patient Radiation Dose With Image Noise Reduction Technology in Transcatheter Aortic Valve Procedures.

    PubMed

    Lauterbach, Michael; Hauptmann, Karl Eugen

    2016-03-01

    X-ray radiation exposure is of great concern for patients undergoing structural heart interventions. In addition, a larger group of medical staff is required and exposed to radiation compared with percutaneous coronary interventions. This study aimed at quantifying radiation dose reduction with implementation of specific image noise reduction technology (NRT) in transcatheter aortic valve implantation (TAVI) procedures. We retrospectively analyzed 104 consecutive patients with TAVI procedures, 52 patients before and 52 after optimization of x-ray radiation chain, and implementation of NRT. Patients with 1-step TAVI and complex coronary intervention, or complex TAVI procedures, were excluded. Before the procedure, all patients received a multislice computed tomography scan, which was used to size aortic annulus, select the optimal implantation plane, valve type and size, and guide valve implantation using a software tool. Air kerma and kerma-area product were compared in both groups to determine patient radiation dose reduction. Baseline parameters, co-morbidity, or procedural data were comparable between groups. Mean kerma-area product was significantly lower (p <0.001) in the NRT group compared with the standard group (60 ± 39 vs 203 ± 106 Gy × cm(2), p <0.001), which corresponds to a reduction of 70%. Mean air kerma was reduced by 64% (494 ± 360 vs 1,355 ± 657 mGy, p <0.001). In conclusion, using optimized x-ray chain combined with specific image noise reduction technology has the potential to significantly reduce by 2/3 radiation dose in standard TAVI procedures without worsening image quality or prolonging procedure time. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Transcatheter aortic valve implantation in very elderly patients: immediate results and medium term follow-up

    PubMed Central

    Pascual, Isaac; Muñoz-García, Antonio J; López-Otero, Diego; Avanzas, Pablo; Jimenez-Navarro, Manuel F; Cid-Alvarez, Belén; del Valle, Raquel; Alonso-Briales, Juan H; Ocaranza-Sanchez, Raimundo; Hernández, José M; Trillo-Nouche, Ramiro; Morís, César

    2015-01-01

    Objective To evaluate immediate transcatheter aortic valve implantation (TAVI) results and medium-term follow-up in very elderly patients with severe and symptomatic aortic stenosis (AS). Methods This multicenter, observational and prospective study was carried out in three hospitals. We included consecutive very elderly (> 85 years) patients with severe AS treated by TAVI. The primary endpoint was to evaluate death rates from any cause at two years. Results The study included 160 consecutive patients with a mean age of 87 ± 2.1 years (range from 85 to 94 years) and a mean logistic EuroSCORE of 18.8% ± 11.2% with 57 (35.6%) patients scoring ≥ 20%. Procedural success rate was 97.5%, with 25 (15.6%) patients experiencing acute complications with major bleeding (the most frequent). Global mortality rate during hospitalization was 8.8% (n = 14) and 30-day mortality rate was 10% (n = 16). Median follow up period was 252.24 ± 232.17 days. During the follow-up period, 28 (17.5%) patients died (17 of them due to cardiac causes). The estimated two year overall and cardiac survival rates using the Kaplan-Meier method were 71% and 86.4%, respectively. Cox proportional hazard regression showed that the variable EuroSCORE ≥ 20 was the unique variable associated with overall mortality. Conclusions TAVI is safe and effective in a selected population of very elderly patients. Our findings support the adoption of this new procedure in this complex group of patients. PMID:26345138

  10. Dynamic device properties of pulse contour cardiac output during transcatheter aortic valve implantation.

    PubMed

    Petzoldt, Martin; Riedel, Carsten; Braeunig, Jan; Haas, Sebastian; Goepfert, Matthias S; Treede, Hendrik; Baldus, Stephan; Goetz, Alwin E; Reuter, Daniel A

    2015-06-01

    This prospective single-center study aimed to determine the responsiveness and diagnostic performance of continuous cardiac output (CCO) monitors based on pulse contour analysis compared with invasive mean arterial pressure (MAP) during predefined periods of acute circulatory deterioration in patients undergoing transcatheter aortic valve implantation (TAVI). The ability of calibrated (CCO(CAL)) and self-calibrated (CCO(AUTOCAL)) pulse contour analysis to detect the hemodynamic response to 37 episodes of balloon aortic valvuloplasty enabled by rapid ventricular pacing was quantified in 13 patients undergoing TAVI. A "low" and a "high" cut-off limit were predefined as a 15 or 25 % decrease from baseline respectively. We found no significant differences between CCO(CAL) and MAP regarding mean response time [low cut-off: 8.6 (7.1-10.5) vs. 8.9 (7.3-10.8) s, p = 0.76; high cut-off: 11.4 (9.7-13.5) vs. 12.6 (10.7-14.9) s, p = 0.32] or diagnostic performance [area under the receiver operating characteristics curve (AUC): 0.99 (0.98-1.0) vs. 1.0 (0.99-1.0), p = 0.46]. But CCOCAL had a significantly higher amplitude response [95.0 (88.7-98.8) % decrease from baseline] than MAP [41.2 (30.0-52.9) %, p < 0.001]. CCOAUTOCAL had a significantly lower AUC [0.83 (0.73-0.93), p < 0.001] than MAP. Moreover, CCO(CAL) detected hemodynamic recovery significantly earlier than MAP. In conclusion, CCO(CAL) and MAP provided equivalent responsiveness and diagnostic performance to detect acute circulatory depression, whereas CCO(AUTOCAL) appeared to be less appropriate. In contrast to CCO(CAL) the amplitude response of MAP was poor. Consequently even small response amplitudes of MAP could indicate severe decreases in CO.

  11. Intracardiac echocardiography: a new guiding tool for transcatheter aortic valve replacement.

    PubMed

    Bartel, Thomas; Bonaros, Nikolaos; Müller, Ludwig; Friedrich, Guy; Grimm, Michael; Velik-Salchner, Corinna; Feuchtner, Gudrun; Pedross, Florian; Müller, Silvana

    2011-09-01

    Echocardiography has been debated as an adjunct for transcatheter aortic valve replacement (TAVR). The aim of this prospective study was to comparatively evaluate intraprocedural guidance using intracardiac echocardiography (ICE) and transesophageal echocardiography (TEE). Fifty high-risk patients with severe aortic stenosis scheduled for TAVR were randomized to either guidance using ICE (group 1; n = 25) or monitoring using TEE (group 2; n = 25). In contrast to TEE, ICE allowed continuous monitoring. The need for probe repositioning during the procedure was much lower in group 1 (0.1 ± 0.3 vs 5.7 ± 0.7 maneuvers, P < .001). Compared with TEE, the transcaval intracardiac echocardiographic view provided higher coaxiality with the ascending aorta expressed as the length of ascending aorta depicted (4.9 ± 1.2 vs 6.1 ± 1.2 cm, P = .003). Both coronary ostia were more frequently visualized in group 1 (18 vs 2 cases, P < .001). ICE-derived annular measurements were correlated closely with preinterventional readings on TEE (n = 25, r(2) = 0.90, P < .001). TEE underestimated intraprocedural pressure gradients in comparison with preinterventional measurements (mean difference, -10.2 ± 11.1 mm Hg; n = 11, P = .012), but ICE did not (mean difference, -0.3 ± 14.1 mm Hg; n = 25, P = .913). ICE and TEE detected newly grown thrombi (2 vs 1 case). Severe complications (e.g., annular dissection, pericardial effusion) were not observed. ICE, which is compatible with sedation and local anesthesia, can be considered an alternative to TEE for intraprocedural guidance during TAVR. It also seems to match the required work flow during TAVR better than TEE. Copyright © 2011 American Society of Echocardiography. Published by Mosby, Inc. All rights reserved.

  12. Association Between Blood Transfusions and 12-Month Mortality After Transcatheter Aortic Valve Implantation.

    PubMed

    Kleczynski, Pawel; Dziewierz, Artur; Bagienski, Maciej; Rzeszutko, Lukasz; Sorysz, Danuta; Trebacz, Jaroslaw; Sobczynski, Robert; Tomala, Marek; Stapor, Maciej; Dudek, Dariusz

    2017-02-07

    Blood transfusions are considered as an important predictor of adverse outcome in patients with severe aortic (AS) undergoing transcatheter aortic valve implantation (TAVI). We sought to investigate the association between blood transfusions and mortality after TAVI. We enrolled 101 consecutive patients with severe AS undergoing TAVI. Patients who required transfusion were defined as patients in whom at least one unit of packed red blood cells (PRBCs) was transfused in the perioperative period. Twelve-month outcomes were assessed based on Valve Academic Research Consortium definitions. A total of 28 (27.7%) patients required blood transfusion after TAVI. Baseline characteristics of the patients with and without a transfusion were similar. Median amount of PRBCs was 2 (interquartile range, 2-4). Twelvemonth all-cause mortality was higher in patients with than without a blood transfusion (39.3% versus 9.6%; P = 0.001). Importantly, the need for a blood transfusion after TAVI was an independent predictor of higher mortality rates after 12 months (hazard ratio (HR) 2.84 95%CI (1.06-7.63); P = 0.039; (HR for incomplete coronary revascularization 10.86, 95%CI 3.72-31.73; P < 0.001; HR for a history of stroke/TIA 3.93, 95%CI 1.39-11.07; P < 0.001). The duration of inhospital stay was longer in patients requiring transfusion (16.0 (14.0-22.0) versus 7.0 (7.0-11.5) days; P = 0.014). In conclusion, blood transfusions after TAVI were associated with higher mortality rates after 12 months, longer in-hospital stay, and were identified as an independent predictor of impaired clinical outcome.

  13. 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.

  14. Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance.

    PubMed

    Alli, Oluseun; Rihal, Charanjit S; Suri, Rakesh M; Greason, Kevin L; Waksman, Ron; Minha, Sa'ar; Torguson, Rebecca; Pichard, Augusto D; Mack, Michael; Svensson, Lars G; Rajeswaran, Jeevanantham; Lowry, Ashley M; Ehrlinger, John; Tuzcu, E Murat; Thourani, Vinod H; Makkar, Raj; Blackstone, Eugene H; Leon, Martin B; Holmes, David

    2016-01-01

    To assess technical performance learning curves of teams performing transfemoral transcatheter aortic valve replacement (TF-TAVR). TF-TAVR is a new procedure for treating severe aortic stenosis. The number of cases required for procedural efficiency is unknown. In the PARTNER-I trial, 1,521 patients underwent TF-TAVR from 4/2007-2/2012. Learning curve analysis of technical performance metrics was performed using institution-specific patient sequence number, interval between procedures, and institutional trial entry date. Learning curve characteristics were assessed using semi-parametric and parametric mixed-effects models. As patient sequence number increased, average procedure time decreased from 154 to 85 minutes (P < 0.0001), and fluoroscopy time from 28 to 20 minutes (P < 0.0001). Procedure time plateaued at an average of 83 minutes (range 52-140). Procedure time plateau was dynamic during the course of the trial, averaging 25 cases (range 21-52) by its end. The later institutions enrolled in the trial, the shorter the initial procedure time. During the trial, percutaneous rather than surgical access increased from 7.9% to 69%. Technical performance learning curves exist for TF-TAVR; procedural efficiency increased with experience, with concomitant decreases in radiation and contrast media exposure. The number of cases needed to achieve efficiency decreased progressively, with optimal procedural performance reached after approximately 25 cases for late-entering institutions. Knowledge and experience accumulated by early TF-TAVR institutions were disseminated, shortening the learning curve of late-entering institutions. Technological advances resulting from learning during the trial moved the field from initial conservative surgical cut-down to percutaneous access for most patients. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  15. 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.

  16. Ventricular conduction defects after transcatheter aortic valve implantation: a single-institute analysis.

    PubMed

    Kawaguchi, Akira T; D'Allessandro, Cosimo; Collet, Jean Philippe; Cluzel, Philippe; Makri, Ralouka; Leprince, Pascal

    2015-05-01

    Patients with aortic stenosis tend to develop ventricular conduction problems, which are known adverse events following transcatheter aortic valve implantation (TAVI). Changes in ventricular conduction status after TAVI were analyzed in 195 consecutive patients from a single institute registered in FRANCE2 between February 2010 and June 2012. Among the 195 patients, 29 had a prior pacemaker implantation (+PM) and 6 had acute catastrophic hemodynamics that made a full electrocardiogram (ECG) unavailable. Among the remaining 160, PM was newly required in 28 (17.5%, PM+) but not in 132 (PM-), which included 21 (13.1%) who developed new left bundle branch block (BBB), 12 (7.5%) had right BBB, and 99 (61.9%) had no change. While PM requirement had no correlation with preoperative factors, there was significant association with the development of right BBB with Edwards Sapien/XT (P = 0.003), and new left BBB (P = 0.012) and complete heart block requiring PM with CoreValve (22.6% vs. Edwards Sapien/XT, 7.4%, P = 0.016). Whereas postoperative survival regarding PM status (+PM, PM+, PM-), vascular access, valve size or type showed no difference, delayed heart block (n = 12, Day 2 or later) was associated with poor survival (P = 0.038) compared with the remaining PM+ patients with earlier onset (n = 16, Day 0 or 1). As a result, PM+ patients (n = 28) had significantly longer intensive care unit (ICU) stay and hospitalization than PM- or +PM patients. The results suggest that ventricular conduction problems requiring PM occurred more frequently after TAVI (17.5%) than with usual surgical replacement. Nonetheless, conduction problems failed to influence postoperative survival for up to 3 years on average with use of PM, but therefore did increase medical costs. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

  17. Radiation Exposure and Contrast Agent Reduction During Transcatheter Aortic Valve Implantation: An Ongoing Experience.

    PubMed

    Maccagni, Davide; Godino, Cosmo; Latib, Azeem; Mancin, Morena; Chieffo, Alaide; Margonato, Alberto; Colombo, Antonio

    2016-11-01

    To determine the patient radiation exposure and contrast agent variation during transcatheter aortic valve implantation (TAVI) procedures resulting from technological improvements. TAVI procedures from January 2008 to July 2015 were analyzed in three different time periods: 1st period, when the angiography was equipped with an image intensifier technology; 2nd period, starting with the installation of a new angiography system with flat-panel detector (FPD) technology; and 3rd period, starting with the systematic use of preprocedural multidetector computed tomography (MDCT) to individualize optimal fluoroscopic projections for the aortic prosthesis implantation. Significant differences were found in contrast volume (198 ± 99 mL vs 139 ± 74 mL; P<.001), kerma area product (211 ± 135 Gy•cm² vs 147 ± 120 Gy•cm²; P<.001) and effective dose (42 ± 27 mSv vs 29 ± 24 mSv; P<.001) between the 1st and 2nd periods, respectively. The reduction continued between the 2nd and 3rd periods for contrast volume (139 ± 74 mL vs 110 ± 61 mL; P<.001), kerma area product (147 ± 120 Gy•cm² vs 111 ± 69 Gy•cm²; P<.001), and effective dose (29 ± 24 mSv vs 22 ± 11 mSv; P<.001), respectively. The present study suggests that the appropriate use of FPD technology and preprocedural MDCT to individualize fluoroscopic implant projections for TAVI temporally reduced the amount of radiation and contrast agent administered over time.

  18. Prevalence and effect of myocardial injury after transcatheter aortic valve replacement.

    PubMed

    Barbash, Israel M; Dvir, Danny; Ben-Dor, Itsik; Badr, Salem; Okubagzi, Petros; Torguson, Rebecca; Corso, Paul J; Xue, Zhenyi; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

    2013-05-01

    The incidence and prognostic implication of myocardial injury after transcatheter aortic valve replacement (TAVR) have not been consistently studied. We aimed to assess the incidence and extent of myocardial injury after TAVR performed using transfemoral and transapical approaches. The clinical data from patients with aortic stenosis who underwent TAVR were retrospectively analyzed. The myocardial necrosis markers cardiac troponin I and creatine kinase (CK)-MB were assessed during hospitalization. Of the 150 TAVR patients, 95% and 50% had an abnormally elevated cardiac troponin I and CK-MB level, respectively. The transapical patients had significantly greater elevations of both cardiac troponin I (13.8 ± 14.0 vs 2.5 ± 5.8 ng/ml, p <0.001) and CK-MB (28.4 ± 24.2 vs 7.4 ± 8.6 ng/ml, p ≤0.001). On receiver operating curve analysis, postprocedural CK-MB (twofold increase) had high predictive power for 30-day mortality (area under the curve 0.85, p <0.001). Patients with high CK-MB levels had greater rates of postprocedural kidney injury (22% vs 6%, p = 0.026), in-hospital (22% vs 0%, p <0.001), 30-day (27% vs 1.5%, p <0.001), and 1-year mortality (41% vs 18%, p = 0.01). Baseline renal failure and no β-blocker treatment on admission were independent predictors of an elevated postprocedural CK-MB level. In conclusion, a cardiac biomarker increase after TAVR was common and more frequent among transapical access patients. A twofold increase (>7 ng/ml) in CK-MB after transfemoral TAVR was a surrogate for poor long-term outcomes.

  19. Embol-X intraaortic filter and transaortic approach for improved cerebral protection in transcatheter aortic valve implantation.

    PubMed

    Etienne, Pierre-Yves; Papadatos, Spiridon; Pieters, Denis; El Khoury, Elie; Alexis, Frédéric; Price, Joel; Glineur, David

    2011-11-01

    Techniques for transcatheter aortic valve implantation involve manipulation of the native aortic valve and the aortic arch. As a result, excellent technical outcomes of this technique remain counterbalanced by a level of neurologic complications that remain unacceptably high. We present here a report of a new potential combined approach to reduce periprocedural neurologic events. After a 6-cm J-shaped upper-mini-sternotomy, 26-mm Sapien valve (Edwards Lifesciences, Irvine, CA) was deployed through a transaortic approach. In addition, the Embol-X device (Edwards Lifescience) was directly inserted in the distal ascending aorta was deployed during all the procedure. Postoperative evolution was clinically uneventful. Postoperative magnetic resonance imaging revealed no new ischemic lesions in this first patient. Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  20. 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.

  1. Staged High-Risk Percutaneous Coronary Intervention with Impella Support after On-Pump Transcatheter Aortic Valve Replacement

    PubMed Central

    Bahekar, Amol A.

    2016-01-01

    The management of concomitant obstructive coronary artery disease and severe aortic stenosis in poor surgical candidates is an evolving topic. Although the typical current practice is to perform percutaneous revascularization before transcatheter aortic valve replacement (TAVR), some data have emerged regarding revascularization after performing TAVR. We present the case of a 90-year-old man with multivessel coronary artery disease who was at prohibitive risk for surgical aortic valve replacement. We first performed TAVR with use of hemodynamic support, then Impella-assisted multivessel percutaneous coronary intervention on the patient's unprotected left main coronary artery. We describe this complex case and review the medical literature on percutaneous coronary intervention after TAVR PMID:27777528

  2. Clinical manifestations of heart failure abate with transcatheter aortic paravalvular leak closure using Amplatzer vascular plug II and III devices.

    PubMed

    Smolka, Grzegorz; Pysz, Piotr; Wojakowski, Wojciech; Ochała, Andrzej; Peszek-Przybyła, Ewa; Roleder, Tomasz; Jasinski, Marek; Gasior, Zbigniew

    2013-05-01

    To evaluate the transcatheter paravalvular leak closure (TPVLC) aptitude to reduce manifestations of heart failure caused by aortic paravalvular leak (PVL). TPVLC is a valuable alternative to reoperation. While technical feasibility of the method is well established, data on long-term clinical outcome are less abundant. We launched a prospective registry of patients with clinically significant aortic PVL. They were scheduled for TPVLC with Amplatzer vascular plug (AVP) II and III devices serving as occluders. The efficacy and safety were monitored at 6-month follow-up exam. The occluder deployment reached a success rate of nearly 90%. Following the procedure, we recorded significant improvement both in terms of patient functional capacity and echocardiographic determinants of left ventricular performance. Simultaneously, NT-proBNP plasma concentration and hemolysis markers decreased. Only local complications related to puncture site occurred. Heart failure caused by aortic PVL can be safely and efficiently treated with TPVLC using AVP II and III devices as occluders.

  3. Comprehensive prospective cognitive and physical function assessment in elderly patients undergoing transcatheter aortic valve implantation.

    PubMed

    Orvin, Katia; Dvir, Danny; Weiss, Avraham; Assali, Abid; Vaknin-Assa, Hana; Shapira, Yaron; Gazit, Osnat; Sagie, Alex; Kornowski, Ran

    2014-01-01

    Transcatheter aortic valve implantation (TAVI) is occasionally associated with stroke and silent cerebral ischemia, which may affect cognitive and functional performance. The aim of this study was to evaluate the changes in cognitive performance and functional status following TAVI. We performed a comprehensive prospective functional, cognitive and quality of life (QOL) evaluation in consecutive patients who underwent TAVI using the CoreValve device (Medtronic Inc.). The evaluation was performed at baseline and 1 month after the procedure and included the 36-item Short-Form Health Survey for QOL assessment, Mini-Mental State Examination (MMSE), quantitative clock drawing test (Rouleau), color trails test, Cognistat evaluation, Barthel Index and Duke Activity Status Index. A total of 36 patients completed the full pre- and post-TAVI evaluation. Mean age was 82.2 ± 4.2 years (52.8% men); 94.5% of patients had low functional class (New York Heart Association III/IV), and 13.9% had prior stroke. After the procedure, all patients had improved functional status and valve hemodynamics. At 1 month, there was a significant improvement in the MMSE and Cognistat evaluations (from 25.9 ± 3.3 to 27.6 ± 2.4, p < 0.001, and from 5 ± 1 to 5.7 ± 0.7, p = 0.001, respectively). Our preliminary results of a comprehensive assessment of patients undergoing TAVI indicate favorable results for both functional performance and cognitive function early after the procedure.

  4. High on-treatment platelet reactivity in transcatheter aortic valve implantation patients.

    PubMed

    Polzin, Amin; Schleicher, Mathias; Seidel, Holger; Scharf, Rüdiger E; Merx, Marc W; Kelm, Malte; Zeus, Tobias

    2015-03-15

    Dual antiplatelet therapy (DAPT) is recommended early after transcatheter aortic valve implantation (TAVI) procedure at the moment despite the lack of evidence. Two small randomized trials failed to demonstrate DAPT to be superior to aspirin alone in TAVI patients. However, it is known that there are substantial response variabilities to antiplatelet medication. We aimed to investigate high on-treatment platelet reactivity (HTPR), low on-treatment platelet reactivity (LTPR) to clopidogrel as well as HTPR to aspirin in patients undergoing TAVI procedure. We analyzed data of 140 TAVI patients in a real world observational study. Platelet function assays (clopidogrel-vasodilator-stimulated protein phosphorylation assay; aspirin-light-transmission aggregometry) have been performed during hospital course. Clinical complications were investigated during 30 days follow-up and defined using the valve academic research consortium standardized criteria. HTPR to clopidogrel occurred in 87 (62%) patients and LTPR in 9 (6.4%) patients. Aspirin antiplatelet effects were insufficient in 25 (18%) patients. Clinical complications were observed in 35 (25%) patients. Ischemic events occurred in 6 (4%), bleeding complications in 28 (20%) patients. There were no differences regarding the incidence of HTPR/LTPR in patients with overall complications, ischemic events or bleeding events. HTPR to clopidogrel is very frequent in TAVI patients. However bleeding complications are frequent and ischemic events are rare. Therefore, future clinical trials investigating the optimal antithrombotic regiment in TAVI patients should consider this high incidence of HTPR to clopidogrel and monitor clopidogrel antiplatelet effects carefully.

  5. Psoas Muscle Area as a Predictor of Outcomes in Transcatheter Aortic Valve Implantation.

    PubMed

    Garg, Lohit; Agrawal, Sahil; Pew, Timothy; Hanzel, George S; Abbas, Amr E; Gallagher, Michael J; Shannon, Francis L; Hanson, Ivan D

    2017-02-01

    Frailty is a powerful predictor of outcomes after transcatheter aortic valve implantation (TAVI). Sarcopenia as assessed by psoas muscle area (PMA) is a validated tool to assess frailty before surgical procedures. We evaluated PMA as a predictor of outcomes after TAVI in 152 consecutive patients who underwent this procedure at our institution from 2011 to 2014. Preoperative computed tomography scans were used to measure PMA, which then was indexed to body surface area. Outcomes evaluated included (1) early poor outcome (30 days mortality, stroke, dialysis, and prolonged ventilation), (2) 1-year mortality, and (3) high-resource utilization (length of stay >7 days, discharge to rehabilitation, or readmission within 30 days). Indexed PMA (odds ratio [OR] 3.19, confidence interval [CI] 1.30 to 7.83; p = 0.012) and age (OR 1.92, CI 1.87 to 1.98; p = 0.012) predicted early poor outcome. Society of Thoracic Surgeons score predicted 1-year mortality (hazard ratio 3.07, CI 1.93 to 6.23; p = 0.011). High-resource utilization was observed more frequently in patients with PMA less than the median (73% vs 51%, OR 2.65, CI 1.32 to 5.36; p = 0.006). In conclusion, indexed PMA predicts early poor outcome and high-resource utilization after TAVI. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. 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

  7. 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.

  8. Surgical Management of Percutaneous Transfemoral Access to Minimize Vascular Complications Related to Transcatheter Aortic Valve' Implantation.

    PubMed

    Lareyre, Fabien; Raffort, Juliette; Dommerc, Carine; Habib, Yacoub; Bourlon, François; Mialhe, Claude

    2017-01-01

    Transcatheter aortic valve implantation (TAVI) is associated with substantial rates of vascular complications. The aim of our study is to describe the surgical management of percutaneous transfemoral access by a vascular surgeon and to report the 30-day postoperative vascular complications and mortality. Perioperative procedures to manage the femoral access site were recorded retrospectively from 220 consecutive patients who underwent TAVI. Postoperative vascular complications related to the main access were categorized according to the Valve Academic Research Consortium 2 classification. Perioperative procedures related to vascular access were performed for 56 (25.4%) patients: 6 patients required open surgical repair, 48 patients underwent endovascular stenting, and 2 patients had both procedures. The all-cause mortality was 3.6%, but no death related to a vascular complication was reported during the 30-day postoperative follow-up period. Ten (4.5%) patients developed postoperative hematomas; 2 (0.9%) of them were retroperitoneal and led to major bleeding requiring an unplanned surgical intervention. Our study underlines the utility of a multidisciplinary approach to manage the percutaneous access in TAVI for managing postoperative vascular complications.

  9. [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.

  10. Intraoperative improvement in left ventricular peak systolic velocity predicts better short-term outcome after transcatheter aortic valve implantation.

    PubMed

    Eidet, Jo; Dahle, Gry; Bugge, Jan Frederik; Bendz, Bjørn; Rein, Kjell Arne; Aaberge, Lars; Offstad, Jon Thomas; Fosse, Erik; Aakhus, Svend; Halvorsen, Per Steinar

    2016-01-01

    Left ventricular function is expected to improve after transcatheter aortic valve implantation due to the acute reduction in afterload, but does not occur in all patients. We hypothesized that the immediate intraoperative response in systolic left ventricular longitudinal motion during the procedure could be a predictor of short-term outcome. Sixty-four patients treated with transcatheter aortic valve implantation for severe aortic stenosis were included. Transoesophageal 4- and 2-chamber echocardiograms were obtained immediately prior to and ∼15 min after valve implantation. Patients were defined as responders if their average left ventricular longitudinal peak systolic velocity increased by ≥20% from the preimplantation value and was related to the 3-month outcome. Thirty-five patients were classified as responders, with an increase in the intraoperative longitudinal peak systolic velocity from an average of 2.2 ± 0.8 to 3.1 ± 1.1 cm/s (P < 0.001); the velocity was unchanged in the remaining 29 patients, who averaged 2.4 ± 1.1 cm/s. There were significantly fewer adverse cardiac events in the responder group at the 3-month follow-up (20 vs 45%, P = 0.03) and the New York Heart Association class was significantly better in the responders compared with non-responders. Responders had a significant reduction in N-terminal probrain natriuretic peptide levels [243 (113-361) vs 163 (64-273), P = 0.004] at the 3-month follow-up, whereas non-responders did not [469 (130-858) vs 289 (157-921), P = 0.48]. An immediate improvement in the longitudinal peak systolic velocity during the transcatheter aortic valve implantation procedure predicted a better short-term outcome and may be useful in identifying patients who are at risk of a less favourable outcome after transcatheter aortic valve implantation. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  11. 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

  12. SOURCE 3: 1-year outcomes post-transcatheter aortic valve implantation using the latest generation of the balloon-expandable transcatheter heart valve.

    PubMed

    Wendler, Olaf; Schymik, Gerhard; Treede, Hendrik; Baumgartner, Helmut; Dumonteil, Nicolas; Neumann, Franz-Josef; Tarantini, Giuseppe; Zamorano, José Luis; Vahanian, Alec

    2017-06-12

    Transcatheter aortic valve implantation (TAVI) has developed from a procedure for patients with aortic stenosis inoperable or high risk for surgery, into a treatment option even for intermediate risk elderly patients. This development has been facilitated by the clinical learning curve and constant improvements of transcatheter heart valves used. We present total 1-year results of SOURCE 3, the European post-approval multicentre registry of the latest generation balloon expandable SAPIEN 3TM (Edwards Lifesciences, Irvine, CA, USA). Participating centres have submitted their consecutive experience with the SAPIEN 3, dependent on patients consent. Data were prospectively collected and all end point-related outcomes adjudicated according to VARC-2 definitions by an independent committee. Between July 2014 and October 2015, in total 1946 patients (mean age 81.6 ± 6.7 years, 52% male) were enrolled in 80 centres from 10 European countries. At 1 year, all-cause mortality was 12.6%, cardiovascular mortality 8.0%, stroke 3.1%, disabling stroke 1.4%, and rate of new pacemakers 13.2%. Causes of death were 62.0% cardiovascular and 38.0% non-cardiovascular, with heart failure (13.4%) and pulmonary complications (12.7%) being the main reasons for fatal outcomes. Multivariable analysis identified New York Heart Association Class IV and renal insufficiency as predictors of mortality, while higher BMI's improved survival. Severe (zero) and moderate paravalvular leakage (2.6%) was rare at 1 year. In SOURCE 3, we observe a low complication rate and mortality at 1 year. Given the low incidence of higher degree paravalvular leakages, this variable did no longer affect outcome. Clinicaltrial.gov number: NCT02698956.

  13. Comparison of Transcatheter and Surgical Aortic Valve Replacement in Severe Aortic Stenosis: A Longitudinal Study of Echo Parameters in Cohort A of the PARTNER Trial

    PubMed Central

    Hahn, Rebecca T.; Pibarot, Philippe; Stewart, William J.; Weissman, Neil J.; Gopalakrishnan, Deepika; Keane, Martin G.; Anwaruddin, Saif; Wang, Zueyue; Bilsker, Martin; Lindman, Brian R.; Herrmann, Howard C.; Kodali, Susheel K.; Thourani, Vinod H.; Svensson, Lars G.; Akin, Jodi J.; Anderson, William N.; Leon, Martin; Douglas, Pamela S.

    2014-01-01

    Objectives To compare echocardiographic findings in patients with critical aortic stenosis following surgical (SAVR) or transcatheter aortic valve replacement (TAVR Background The Placement of Aortic Transcatheter Valves trial randomized patients 1:1 to SAVR or TAVR Methods Echocardiograms were obtained at baseline, discharge, 30 days, 6 months, 1 year, and 2 years post procedure and analyzed in a core laboratory. For the analysis of post-implant variables, the first interpretable study (≤ 6 mos) was used. Results Both groups showed a decrease in aortic valve gradients and increase in effective orifice area (EOA) (p < 0.0001) which remained stable over 2 years. Compared to SAVR, TAVR resulted in: larger indexed EOA (p = 0.038), less prosthesis-patient mismatch (p = 0.019), and more total and paravalvular aortic regurgitation (AR) (p < 0.0001). Baseline echocardiographic univariate predictors of death were: lower peak transaortic gradient in TAVR patients; low left ventricular diastolic volume (LVDV), low stroke volume, and greater severity of mitral regurgitation in SAVR patients. Post-implantation echocardiographic univariate predictors of death were: larger LVDV, systolic volume (LVSV) and EOA, decreased ejection fraction, and greater AR in TAVR patients; smaller LVSV and LVDV, low stroke volume, smaller EOA and prosthesis-patient mismatch in SAVR patients. Conclusions Patients randomized to either SAVR or TAVR experience enduring, significant reductions in transaortic gradients and increase in EOA. Compared to SAVR, TAVR patients had higher indexed EOA, lower prosthesis-patient mismatch and more AR. Univariate predictors of death for the TAVR group and SAVR groups differed and may allow future refinement in patient selection. PMID:23623915

  14. Anesthetic Considerations for Common Procedures in Geriatric Patients: Hip Fracture, Emergency General Surgery, and Transcatheter Aortic Valve Replacement.

    PubMed

    Lester, Laeben

    2015-09-01

    The elderly population is growing. Geriatric patients undergo a large proportion of surgical procedures and have increased complications, morbidity, and mortality, which may be associated with increased intensive care unit time, length of stay, hospital readmission, and cost. Identification of optimal anesthetic care for these patients, leading to decreased complications and contributing to best possible outcomes, will have great value. This article reviews the anesthetic considerations for intraoperative care of geriatric patients and focus on 3 procedures (hip fractures, emergency abdominal surgery, and transcatheter aortic valve replacement). An approach to evaluation and management of the elderly surgical patient is described. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. Recovery of atrioventricular conduction in patients with heart block after transcatheter aortic valve replacement.

    PubMed

    Raelson, Colin A; Gabriels, James; Ruan, Jonathan; Ip, James E; Thomas, George; Liu, Christopher F; Cheung, Jim W; Lerman, Bruce B; Patel, Apoor; Markowitz, Steven M

    2017-07-05

    Recovery of conduction has been demonstrated in >50% of patients who receive pacemakers (PPMs) for high-degree atrioventricular block (HD-AVB) after transcatheter aortic valve replacement (TAVR). Little information is available about the time course of conduction recovery in these patients and if any features predict early recovery of conduction. A retrospective review was performed of patients who underwent TAVR with balloon and self-expanding valves who required PPMs for HD-AVB. Serial PPM interrogations were analyzed to detect recovery of AV conduction. Analysis was performed to identify predictors and timing of conduction recovery. Of a total population of 578 patients, 54 (9%) received PPMs for HD-AVB. In multivariate analysis, predictors of HD-AVB requiring a PPM included age (P = 0.014), right bundle branch block (OR 7.33 [3.64-14.8], P < 0.0001), atrial fibrillation (OR 2.16 [1.16-4.05], P = 0.016), and self-expanding valves (OR 4.19 [2.20-7.97], P < 0.0001). Of the 54 patients who received PPMs, 38 had follow-up sufficient to evaluate AV conduction recovery. Of these, 23 (61%) showed recovery of AV nodal conduction; 20 had already recovered by their first interrogation, a median of 22 days (IQR 14-31) post-PPM placement. There were no statistically significant predictors of AV nodal conduction recovery, including type of valve implanted. A majority of patients who receive PPMs for HD-AVB after TAVR recover AV conduction during follow-up, and in most patients conduction recovery occurs within weeks. These findings imply that programming to minimize ventricular pacing may be beneficial in a majority of these patients. © 2017 Wiley Periodicals, Inc.

  16. Comparison of two antiplatelet therapy strategies in patients undergoing transcatheter aortic valve implantation.

    PubMed

    Durand, Eric; Blanchard, Didier; Chassaing, Stephan; Gilard, Martine; Laskar, Marc; Borz, Bogdan; Lafont, Antoine; Barbey, Christophe; Godin, Matthieu; Tron, Christophe; Zegdi, Rachid; Chatel, Didier; Le Page, Olivier; Litzler, Pierre-Yves; Bessou, Jean-Paul; Danchin, Nicolas; Cribier, Alain; Eltchaninoff, Hélène

    2014-01-15

    Dual antiplatelet therapy is commonly used in patients undergoing transcatheter aortic valve implantation (TAVI), but the optimal antiplatelet regimen is uncertain and remains to be determined. The objective of this study was to compare 2 strategies of antiplatelet therapy in patients undergoing TAVI. A strategy using monoantiplatelet therapy (group A, n = 164) was prospectively compared with a strategy using dual antiplatelet therapy (group B, n = 128) in 292 consecutive patients undergoing TAVI. The primary end point was a combination of mortality, major stroke, life-threatening bleeding (LTB), myocardial infarction, and major vascular complications at 30 days. All adverse events were adjudicated according to the Valve Academic Research Consortium. The primary end point occurred in 22 patients (13.4%) in the group A and in 30 patients (23.4%) in the group B (hazard ratio 0.51, 95% confidence interval 0.28 to 0.94, p = 0.026). LTB (3.7% vs 12.5%, p = 0.005) and major bleedings (2.4% vs 13.3%, p <0.0001) occurred less frequently in the group A, whereas the incidence of stroke (1.2% vs 4.7%, p = 0.14) and myocardial infarction (1.2% vs 0.8%, p = 1.0) was not significantly different between the 2 groups. The benefit of a strategy using mono versus dual antiplatelet therapy persisted after multivariate adjustment and propensity score analysis (hazard ratio 0.53, 95% confidence interval 0.28 to 0.95, p = 0.033). In conclusion, a strategy using mono versus dual antiplatelet therapy in patients undergoing TAVI reduces LTB and major bleedings without increasing the risk of stroke and myocardial infarction. The results of our study question the justification of dual antiplatelet therapy and require confirmation in a randomized trial. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Incidence of Postoperative Delirium and Its Impact on Outcomes After Transcatheter Aortic Valve Implantation.

    PubMed

    Bagienski, Maciej; Kleczynski, Pawel; Dziewierz, Artur; Rzeszutko, Lukasz; Sorysz, Danuta; Trebacz, Jaroslaw; Sobczynski, Robert; Tomala, Marek; Stapor, Maciej; Dudek, Dariusz

    2017-10-01

    There are limited data on the occurrence of postoperative delirium after transcatheter aortic valve implantation (TAVI). We sought to investigate the incidence of delirium after TAVI and its impact on clinical outcomes. A total of 148 consecutive patients who underwent TAVI were enrolled. Of these patients, 141 patients survived hospital stay. The incidence of delirium was assessed in these patients for the first 4 days after the index procedure. The patients were divided into 2 groups based on the presence of delirium. Baseline characteristics, procedural and long-term outcomes, and frailty and quality-of-life indexes were compared among the groups. Of the 141 patients analyzed, 29 patients developed delirium. The transapical access was more common in patients with delirium (51.7% vs 8.9%, p <0.001). A greater median contrast volume load in the delirium group was noted (75 vs 100 ml, p = 0.001). Significantly more patients with delirium were considered as frail before TAVI. Thirty-day and 12-month all-cause mortality rates were higher in the delirium group (0.0% vs 17.2%, p <0.001; and 3.6% vs 37.9%, p <0.001, respectively). Differences in mortality were significant even after adjustment for baseline characteristics. The quality of life at 12 months, assessed by the 3-level version of the EuroQol 5-dimensional questionnaire, was similar in both groups. Despite a relatively minimally invasive character of TAVI as compared with surgery, some patients experience delirium after TAVI. Importantly, the occurrence of delirium after TAVI may help to identify patients with worse short- and long-term outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. 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.

  19. Clinical outcomes of transcatheter aortic valve implantation: from learning curve to proficiency

    PubMed Central

    Lunardi, Mattia; Pesarini, Gabriele; Zivelonghi, Carlo; Piccoli, Anna; Geremia, Giulia; Ariotti, Sara; Rossi, Andrea; Gambaro, Alessia; Gottin, Leonardo; Faggian, Giuseppe; Vassanelli, Corrado; Ribichini, Flavio

    2016-01-01

    Objective The use of transcatheter aortic valve implantation (TAVI) is growing rapidly in countries with a predominantly elderly population, posing a huge challenge to healthcare systems worldwide. The increment of human and economic resource consumption imposes a careful monitoring of clinical outcomes and cost-benefit balance, and this article is aimed at analysing clinical outcomes related to the TAVI learning curve. Methods Outcomes of 177 consecutive transfemoral TAVI procedures performed in 5 years by a single team were analysed by the Cumulative Sum of failures method (CUSUM) according to the clinical events comprised in the Valve Academic Research Consortium (VARC-2) safety end point and the VARC-2 definition of device success. Margins for events acceptance were extrapolated from landmark trials that tested both balloon or self-expandable percutaneous valves. Results 30-day and 1-year survival rates were 97.2% and 89.9%, respectively. Achievement of the primary end point (number of cases needed to provide the acceptable margin of the composite end point of any death, stroke, myocardial infarction, life-threatening bleeding, major vascular complications, stage 2–3 acute kidney injury and valve-related dysfunction requiring a repeat procedure) required the performance of 54 cases, while the learning curve to achieve ‘device success’ identified 32 cases to reach the expected proficiency. In this experience, the baseline clinical risk as assessed by the Society of Thoracic Surgeons (STS) score determined the long-term survival rather than the adverse events related to the learning curve. Conclusions A relatively large number of cases are required to achieve clinical outcomes comparable to those reported in high-volume centres and controlled trials. According to our national workload standards, this represents more than 2 years of continuous activity. PMID:27621826

  20. Neurologic Complications of Unprotected Transcatheter Aortic Valve Implantation (from the Neuro-TAVI Trial).

    PubMed

    Lansky, Alexandra J; Brown, David; Pena, Constantino; Pietras, Cody G; Parise, Helen; Ng, Vivian G; Meller, Stephanie; Abrams, Kevin J; Cleman, Michael; Margolis, Pauliina; Petrossian, George; Brickman, Adam M; Voros, Szilard; Moses, Jeffrey; Forrest, John K

    2016-11-15

    Cerebral embolization during transcatheter aortic valve implantation (TAVI) can lead to a spectrum of clinically relevant manifestations, ranging from overt stroke to mild neurologic or cognitive deficits and subclinical cerebral infarcts. This study sought to determine the frequency of neurologic injury, cerebral ischemic lesions, and cognitive dysfunction in subjects undergoing contemporary commercial TAVI in the United States. Neuro-TAVR is the first prospective, multicenter study to use serial systematic neurologic and cognitive assessments and diffusion-weighted magnetic resonance imaging (at 4 ± 2 days after procedure) to investigate the incidence and severity of neurologic injury after contemporary unprotected TAVI in the United States. A total of 44 consecutive patients underwent TAVI at 5 US sites. Diffusion-weighted magnetic resonance imaging lesions were detected in 94%, with a mean of 10.4 ± 15.3 lesions per subject and a median total lesion volume of 295 mm(3) (interquartile range 71.6 to 799.6 mm(3)). New neurologic impairment (worsening in National Institutes of Health Stroke Scale score from baseline with new cerebral lesions) occurred in 22.6% (7 of 31) of subjects at discharge and 14.8% (4 of 27) at 30 days. In addition, cognitive decrements from baseline were identified by the Montreal Cognitive Assessment in 33% (12 of 36) of subjects at discharge and 41% (13 of 32) at 30 days. In conclusion, this contemporary cohort of US patients confirms that TAVI results in cerebral infarction in most patients and that 1 in 5 patients have measurable neurologic impairment and 1 in 3 patients have decrease in cognitive measures by Montreal Cognitive Assessment score after TAVI, reinforcing the need for methods to mitigate the risk of brain injury during TAVI.

  1. Clinical outcomes after trans-catheter aortic valve replacement in men and women in Ontario, Canada.

    PubMed

    Czarnecki, Andrew; Qiu, Feng; Koh, Maria; Prasad, Treesa J; Cantor, Warren J; Cheema, Asim N; Chu, Michael W A; Feindel, Christopher; Fremes, Stephen E; Kingsbury, Kori; Natarajan, Madhu K; Peterson, Mark D; Ruel, Marc; Strauss, Bradley H; Wijeysundera, Harindra C; Ko, Dennis T

    2017-09-01

    Our objective was to evaluate sex-differences in outcomes after trans-catheter aortic valve replacement (TAVR) in a population-based cohort from Ontario, Canada. Prior studies comparing outcomes in men and women after TAVR have yielded divergent results. Some studies have suggested that women have better survival than men while others have not corroborated this finding. A retrospective observational cohort study was conducted using chart abstraction data on all TAVR procedures performed between 2007 and 2013 in Ontario, Canada. Patients who had emergency TAVR procedures were excluded. The primary outcome was all-cause mortality at 30-days and 1-year. Secondary outcomes included mortality at last follow-up, cause-specific, and all-cause hospital readmission. Inverse probability of treatment weighting (IPTW) using propensity score was used to adjust for baseline differences between men and women. The final study cohort consisted of 453 women and 546 men with a mean follow-up of 3.5 years. Women were generally older and more frail but had less comorbid conditions. Women had lower unadjusted mean EuroScores (7% ± 5% vs 8% ± 7%; P = 0.008), but underwent significantly more trans-apical procedures (26.5% vs 19.2%; P = 0.006) than men. After IPTW, the groups were well balanced. Although mortality was numerically higher for women at 30-days (7.2% vs 5.4%), this was not statistically significant (P = 0.34). At 1-year, there was no difference in mortality (18.2% vs 19.2%; P = 0.85). There were no significant differences in all-cause readmission. In this population-based cohort including all patients undergoing TAVR, mortality or all-cause readmission were not significantly different between men and women. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  2. 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

  3. Impact of clinical and procedural factors upon C reactive protein dynamics following transcatheter aortic valve implantation

    PubMed Central

    Ruparelia, Neil; Panoulas, Vasileios F; Frame, Angela; Ariff, Ben; Sutaria, Nilesh; Fertleman, Michael; Cousins, Jonathan; Anderson, Jon; Bicknell, Colin; Chukwuemeka, Andrew; Sen, Sayan; Malik, Iqbal S; Colombo, Antonio; Mikhail, Ghada W

    2016-01-01

    AIM: To determine the effect of procedural and clinical factors upon C reactive protein (CRP) dynamics following transcatheter aortic valve implantation (TAVI). METHODS: Two hundred and eight consecutive patients that underwent transfemoral TAVI at two hospitals (Imperial, College Healthcare NHS Trust, Hammersmith Hospital, London, United Kingdom and San Raffaele Scientific Institute, Milan, Italy) were included. Daily venous plasma CRP levels were measured for up to 7 d following the procedure (or up to discharge). Procedural factors and 30-d safety outcomes according to the Valve Academic Research Consortium 2 definition were collected. RESULTS: Following TAVI, CRP significantly increased reaching a peak on day 3 of 87.6 ± 5.5 mg/dL, P < 0.001. Patients who developed clinical signs and symptoms of sepsis had significantly increased levels of CRP (P < 0.001). The presence of diabetes mellitus was associated with a significantly higher peak CRP level at day 3 (78.4 ± 3.2 vs 92.2 ± 4.4, P < 0.001). There was no difference in peak CRP release following balloon-expandable or self-expandable TAVI implantation (94.8 ± 9.1 vs 81.9 ± 6.9, P = 0.34) or if post-dilatation was required (86.9 ± 6.3 vs 96.6 ± 5.3, P = 0.42), however, when pre-TAVI balloon aortic valvuloplasty was performed this resulted in a significant increase in the peak CRP (110.1 ± 8.9 vs 51.6 ± 3.7, P < 0.001). The development of a major vascular complication did result in a significantly increased maximal CRP release (153.7 ± 11.9 vs 83.3 ± 7.4, P = 0.02) and there was a trend toward a higher peak CRP following major/life-threatening bleeding (113.2 ± 9.3 vs 82.7 ± 7.5, P = 0.12) although this did not reach statistical significance. CRP was not found to be a predictor of 30-d mortality on univariate analysis. CONCLUSION: Careful attention should be paid to baseline clinical characteristics and procedural factors when interpreting CRP following TAVI to determine their future management. PMID

  4. Impact of clinical and procedural factors upon C reactive protein dynamics following transcatheter aortic valve implantation.

    PubMed

    Ruparelia, Neil; Panoulas, Vasileios F; Frame, Angela; Ariff, Ben; Sutaria, Nilesh; Fertleman, Michael; Cousins, Jonathan; Anderson, Jon; Bicknell, Colin; Chukwuemeka, Andrew; Sen, Sayan; Malik, Iqbal S; Colombo, Antonio; Mikhail, Ghada W

    2016-07-26

    To determine the effect of procedural and clinical factors upon C reactive protein (CRP) dynamics following transcatheter aortic valve implantation (TAVI). Two hundred and eight consecutive patients that underwent transfemoral TAVI at two hospitals (Imperial, College Healthcare NHS Trust, Hammersmith Hospital, London, United Kingdom and San Raffaele Scientific Institute, Milan, Italy) were included. Daily venous plasma CRP levels were measured for up to 7 d following the procedure (or up to discharge). Procedural factors and 30-d safety outcomes according to the Valve Academic Research Consortium 2 definition were collected. Following TAVI, CRP significantly increased reaching a peak on day 3 of 87.6 ± 5.5 mg/dL, P < 0.001. Patients who developed clinical signs and symptoms of sepsis had significantly increased levels of CRP (P < 0.001). The presence of diabetes mellitus was associated with a significantly higher peak CRP level at day 3 (78.4 ± 3.2 vs 92.2 ± 4.4, P < 0.001). There was no difference in peak CRP release following balloon-expandable or self-expandable TAVI implantation (94.8 ± 9.1 vs 81.9 ± 6.9, P = 0.34) or if post-dilatation was required (86.9 ± 6.3 vs 96.6 ± 5.3, P = 0.42), however, when pre-TAVI balloon aortic valvuloplasty was performed this resulted in a significant increase in the peak CRP (110.1 ± 8.9 vs 51.6 ± 3.7, P < 0.001). The development of a major vascular complication did result in a significantly increased maximal CRP release (153.7 ± 11.9 vs 83.3 ± 7.4, P = 0.02) and there was a trend toward a higher peak CRP following major/life-threatening bleeding (113.2 ± 9.3 vs 82.7 ± 7.5, P = 0.12) although this did not reach statistical significance. CRP was not found to be a predictor of 30-d mortality on univariate analysis. Careful attention should be paid to baseline clinical characteristics and procedural factors when interpreting CRP following TAVI to determine their future management.

  5. Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry†.

    PubMed

    Romano, Mauro; Frank, Derk; Cocchieri, Riccardo; Jagielak, Dariusz; Bonaros, Nikolaos; Aiello, Marco; Lapeze, Joel; Laine, Mika; Chocron, Sidney; Muir, Douglas; Eichinger, Walter; Thielmann, Matthias; Labrousse, Louis; Arne Rein, Kjell; Verhoye, Jean-Philippe; Gerosa, Gino; Baumbach, Hardy; Deutsch, Cornelia; Bramlage, Peter; Thoenes, Martin; Bapat, Vinayak

    2017-06-05

    Transaortic (TAo) access for transcatheter aortic valve implantation (TAVI) is an alternative to the conventional transfemoral or transapical routes. Data comparing the characteristics and outcomes of TAo-TAVI using the SAPIEN XT and SAPIEN 3 heart valves are scarce. The objective of the current analysis was to provide such information. ROUTE is an international, prospective, observational registry. Patients with severe calcific aortic stenosis scheduled for TAo-TAVI with an Edwards SAPIEN XT or a SAPIEN 3 heart valve were consecutively enrolled at 22 centres across Europe between February 2013 and February 2015. Periprocedural, in-hospital and 30-day complication rates were assessed. Of the 301 patients included, 126 (41.9%) received a SAPIEN 3 and 175 (58.1%) a SAPIEN XT. The SAPIEN 3 was associated with shorter procedure time (101 ± 35 vs 111 ± 40 min; P  = 0.031) and a lower quantity of contrast agent used (87 ± 43 vs 112 ± 50 ml; P  < 0.001). Balloon dilation was performed less often before (68.0% vs 78.3%; P  = 0.045) and after implantation (13.6% vs 30.1%; P  = 0.001). No statistically significant differences between the valve types were documented for overall (4.1% SAPIEN 3 vs 7.6% SAPIEN XT; P  = 0.21), TAVI-related (0.8% vs 4.7%; P  = 0.084) and cardiovascular mortality (2.4% vs 5.9%; P  = 0.158). Major vascular complications were less frequent (0.8% vs 5.3%; P  = 0.049), and there was a lower rate of moderate-to-severe paravalvular regurgitation (0.8% vs 5.1%; P  = 0.050) in the SAPIEN 3 group. Both the SAPIEN XT and SAPIEN 3 were safely implanted via the TAo route, though the SAPIEN 3 may be associated with a higher procedural success rate and improved prognosis. NCT01991431.

  6. A comparative study between propofol and dexmedetomidine as sedative agents during performing transcatheter aortic valve implantation.

    PubMed

    Khalil, Mohamed; Al-Agaty, Ahmed; Asaad, Osama; Mahmoud, Mohsen; Omar, Amr S; Abdelrazik, Ahmed; Mostafa, Mohamed

    2016-08-01

    The type of sedative drugs could play a major role in providing hemodynamic stability which is crucial during transcatheter aortic valve implantation (TAVI) procedure. The aim of this study is to compare propofol with dexmedetomidine for conscious sedation during TAVI. A prospective randomized pilot study. Fifty patients with a mean age of 74years, American Society of Anesthesiologists 3-4, complaining from severe aortic stenosis were enrolled in this study to undergo TAVI. The propofol group (group P; n=25) received a bolus dose of 0.5mg/kg propofol followed by a continuous intravenous infusion of propofol at a rate of 30 to 50μg kg(-1) min(-1), and the dexmedetomidine group (group D; n=25) received dexmedetomidine at a loading dose of 1μg/kg and then a continuous intravenous infusion of dexmedetomidine at a rate of 0.5μg kg(-1) h(-1). Heart rate, mean arterial blood pressure, number of phenylephrine boluses, oxygen saturation, sedation, and satisfaction scores were measured just after the start of infusion of the sedation drugs and at the end of the procedure. Postoperative complications were also recorded. There was a statistically significant reduction in the heart rate in group D in comparison to group P where it was 67.28±6.9beats/min in the first group in comparison to 78±6.9beats/min in the last one (P<.001). The mean arterial blood pressure was statistically significant lower in group D in comparison to group P (58.12±5.4mm Hg in group D vs 68.24±11.4mm Hg in group P; P<.001). Also, the number of phenylephrine boluses was higher in group D than in group P (36.5±7.17 in group D vs 20.6±2.07 in group p; P<.001). No difference between the 2 groups regarding oxygen saturation, sedation, pain, satisfaction scores, and postoperative complications. During TAVI, dexmedetomidine may be associated with significant hypotension and bradycardia rather than propofol. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. 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.

  8. Vascular complications with transcatheter aortic valve implantation using the 18 Fr Medtronic CoreValve System: the Rotterdam experience.

    PubMed

    Van Mieghem, Nicolas M; Nuis, Rutger-Jan; Piazza, Nicolo; Apostolos, Tzikas; Ligthart, Jurgen; Schultz, Carl; de Jaegere, Peter P; Serruys, Patrick W

    2010-01-01

    Transcatheter aortic valve implantation (TAVI) requires large bore catheters. Access site complications, therefore, can be a concern. The aim of this study is to present the 30-day incidence of major and minor vascular complications in patients treated with the third generation 18 Fr Medtronic CoreValve System. We prospectively evaluated the vascular complications occurring in all patients treated with the 18 Fr Medtronic CoreValve System between October 2006 and October 2009 in the Thoraxcenter using various proposed definitions. Ninety-nine consecutive patients were treated with TAVI using the 18 Fr Medtronic CoreValve System. Vascular events were encountered in 13 patients (13%), seven of these cases (54%) were related to incomplete arteriotomy closure with the Prostar device which is the default access closure technique in our centre. Depending on how major vascular complications were defined, the incidence varied from 4 to 13%. Blood transfusions in combination with surgical or percutaneous intervention were required in eight cases. Transcatheter aortic valve implantation with the 18 Fr Medtronic CoreValve System(R) has a 4 to 13% vascular complications' rate. More than half of the vascular events were due to incomplete Prostar arteriotomy closure, despite its use by experienced operators. Current percutaneous closure devices for these large arteriotomies seems suboptimal. Uniformity in how to define TAVI related vascular complications is needed.

  9. In vivo imaging and computational analysis of the aortic root. Application in clinical research and design of transcatheter aortic valve systems.

    PubMed

    Schoenhagen, Paul; Hill, Alexander; Kelley, Tim; Popovic, Zoran; Halliburton, Sandra S

    2011-08-01

    Valvular heart disease is a major cause of morbidity and mortality in developing and industrialized countries. For patients with advanced symptomatic disease, surgical open-heart valve replacement is an effective treatment, supported by long-term outcome data. More recently, less-invasive transcatheter approaches for valve replacement/implantation have been developed for patients that are not considered surgical candidates. An understanding of valvular and paravalvular anatomy and biomechanics is pivotal for the optimization of interventional valve procedures. Advanced imaging is increasingly used not only for clinical guidance but also for the design and further improvement of transcatheter valve systems. Computed tomography is particularly attractive because it acquires high-resolution volumetric data sets of the root including the leaflets and coronary artery ostia, with sufficient temporal resolution for multi-phasic analysis. These volumetric data sets allow subsequent 3-D and 4-D display, reconstruction in unlimited planes, and mathematical modeling. Computer modeling, specifically finite element analysis, of devices intended for implantation in the aortic root, allows for structural analysis of devices and modeling of the interaction between the device and cardiovascular anatomy. This paper will provide an overview of computer modeling of the aortic root and describe FEA approaches that could be applied to TAVI and have an impact on clinical practice and device design.

  10. A novel contribution towards coherent and reproducible intravalvular measurement of the aortic annulus by multidetector computed tomography ahead of transcatheter aortic valve implantation.

    PubMed

    Dementhon, Julie; Rioufol, Gilles; Obadia, Jean-François; Vergnat, Mathieu; Green, Lisa; Croisille, Pierre; Boussel, Loïc; Peron, Julien; Revel, Didier; Finet, Gérard

    2015-05-01

    As current multidetector computed tomography (MDCT) measurements underestimate the size of the aortic annulus ahead of transcatheter aortic valve implantation (TAVI), a strategy of approximate annulus area oversizing has been adopted recently. To measure the aortic annulus using a novel complementary intravalvular MDCT slice. Fifty-five patients with severe aortic stenosis were selected for MDCT ahead of and 1 month after CoreValve(®) TAVI. Two MDCT slices were analysed and compared: the current standard virtual basal ring (VBR) at the nadir of the aortic cusps; and a novel slice, defined as the basal (lowest) complete commissural coaptation (BCCC) plane. BCCC is an intravalvular plane lying 5.2±0.8 mm above the VBR. The BCCC annulus is almost circular, unlike the VBR (mean eccentricity index 0.09±0.04 vs 0.3±0.1, respectively). The mean BCCC annulus diameter was 26.6±2.3 mm, 16% larger than that of the VBR (23.9±2.2 mm; P<0.001). The BCCC annulus area proved coherent with the orifice area measured after TAVI on the projection of the same slice (i.e. systematically equal to or greater than the latter [mean difference, +2.3±1.4 mm]), in contrast to the wider scatter found for the VBR (-1.3±2.0 mm). Once the sclerotic calcified valves have been pushed back by the implant, the aortic orifice after TAVI will inevitably be equal to or less than the diameter of the virtually unvalved annulus before TAVI. Based on the present results, we recommend including a BCCC slice to complete aortic annulus sizing, in order to optimize implant calibration. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  11. Prosthesis/annulus discongruence assessed by three-dimensional transoesophageal echocardiography: a predictor of significant paravalvular aortic regurgitation after transcatheter aortic valve implantation.

    PubMed

    Santos, Ninel; de Agustín, José Alberto; Almería, Carlos; Gonçalves, Alejandra; Marcos-Alberca, Pedro; Fernández-Golfín, Covadonga; García, Eulogio; Hernández-Antolín, Rosana; de Isla, Leopoldo Pérez; Macaya, Carlos; Zamorano, José

    2012-11-01

    Paravalvular aortic regurgitation (AR) is common after transcatheter aortic valve implantation (TAVI). This study aimed to assess the prosthesis/aortic annulus discongruence by three-dimensional (3D) transoesophageal (TOE) planimetry of aortic annulus and its impact on the occurrence of significant AR after TAVI. We included 33 patients who underwent TAVI with a balloon expandable device for severe aortic stenosis. To appraise the prosthesis/annulus discongruence, we defined a 'mismatch index' expressed as: annulus area - prosthesis area. The aortic annulus area was planimetered with 3D TOE, and approximated by circular area formula (π r(2)) using annulus diameter obtained by two-dimensional (2D) TOE. After TAVI, 13 patients (39.3%) developed significant AR (≥2/4). The occurrence of significant AR was associated to the 3D planimetered annulus area (P = 0.04), and the 'mismatch index' obtained through 3D planimetered annulus area (P = 0.03), but not to 'mismatch index' derived of 2D annulus diameter. In multivariate analysis, 'mismatch index' for 3D planimetered annulus area was the only independent predictor of significant AR (odds ratio: 10.614; 95% CI: 1.044-17.21; P = 0.04). The area under the receiver operating characteristic curve for the 'mismatch index' by the 3D planimetered annulus area was 0.76 (95% CI: 0.54-0.92), whereas for 'mismatch index' obtained by the 2D circular area was 0.36 (95% CI: 0.17-0.55). Using the 3D planimetered annulus area as the reference parameter to decide the prosthetic size, the choice would have been different in 21 patients (63%). Three-dimensional TOE planimetry of aortic annulus improves the assessment of prosthesis/annulus discongruence and predicts the appearance of significant AR after TAVI.

  12. Primary Mitral Valve Regurgitation Outcome in Patients With Severe Aortic Stenosis 1 Year After Transcatheter Aortic Valve Implantation: Echocardiographic Evaluation.

    PubMed

    Florentino, Thiago Marinho; Bihan, David Le; Abizaid, Alexandre Antonio Cunha; Cedro, Alexandre Vianna; Corrêa, Amably Pessoa; Santos, Alexandre Roginski Mendes Dos; Souza, Alexandre Costa; Bignoto, Tiago Costa; Sousa, José Eduardo Moraes Rego; Sousa, Amanda Guerra de Moraes Rego

    2017-07-10

    Mitral valve regurgitation (MR), present in up to 74% of the patients with severe aortic stenosis (AS), can be a negative prognostic factor when moderate or severe. The outcome of MR after percutaneous transcatheter aortic valve implantation (TAVI) and predictors associated with that outcome have not been well established in the literature. To assess the outcome of primary MR in patients submitted to TAVI and to identify associated factors. Observational study of patients with symptomatic severe AS submitted to TAVI from January 2009 to April 2015 at two specialized centers. Echocardiographic outcome was assessed with data collected before and 1 year after TAVI. Of the 91 patients with MR submitted to TAVI and followed up for at least 12 months, 67 (73.6%) had minimum/mild MR before the procedure and 24 (26.4%) had moderate/severe MR. Of those with minimum/mild MR, 62 (92.5%) had no change in the MR grade (p < 0.001), while 5 (7.5%) showed worsening. Of those with moderate/severe MR, 8 (33.3%) maintained the same grade and 16 (66.7%) improved it (p = 0.076). Patients with moderate/severe MR who improved MR grade had lower EuroSCORE II (p = 0.023) and STS morbidity (p = 0.027) scores, as compared to those who maintained the MR grade. MR grades change after TAVI. This study suggests a trend towards improvement in moderate/severe MR after TAVI, which was associated with lower preoperative risk scores. A insuficiência valvar mitral (IM), presente em até 74% dos pacientes com estenose aórtica (EA) grave, pode representar um fator prognóstico negativo quando moderada ou importante. A evolução da IM após implante percutâneo de valva aórtica transcateter (TAVI) e preditores associados a essa evolução não estão bem estabelecidos na literatura. Avaliar a evolução da IM primária em pacientes submetidos ao TAVI e identificar fatores associados a essa evolução. Realizou-se um estudo observacional em pacientes com EA grave sintomática, submetidos ao TAVI no

  13. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study.

    PubMed

    Meredith Am, Ian T; Walters, Darren L; Dumonteil, Nicolas; Worthley, Stephen G; Tchétché, Didier; Manoharan, Ganesh; Blackman, Daniel J; Rioufol, Gilles; Hildick-Smith, David; Whitbourn, Robert J; Lefèvre, Thierry; Lange, Rüdiger; Müller, Ralf; Redwood, Simon; Allocco, Dominic J; Dawkins, Keith D

    2014-09-30

    Transcatheter aortic valve replacement provides results comparable to those of surgery in patients at high surgical risk, but complications can impact long-term outcomes. The Lotus valve, designed to improve upon earlier devices, is fully repositionable and retrievable, with a unique seal to minimize paravalvular regurgitation (PVR). The prospective, single-arm, multicenter REPRISE II study (REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System: Evaluation of Safety and Performance) evaluated the transcatheter valve system for treatment of severe symptomatic calcific aortic valve stenosis. Patients (n = 120; aortic annulus 19 to 27 mm) considered by a multidisciplinary heart team to be at high surgical risk received the valve transfemorally. The primary device performance endpoint, 30-day mean pressure gradient, was assessed by an independent echocardiographic core laboratory and compared with a pre-specified performance goal. The primary safety endpoint was 30-day mortality. Secondary endpoints included safety/effectiveness metrics per Valve Academic Research Consortium criteria. Mean age was 84.4 years, 57% of the patients were female, and 76% were New York Heart Association functional class III/IV. Mean aortic valve area was 0.7 ± 0.2 cm(2). The valve was successfully implanted in all patients, with no cases of valve embolization, ectopic valve deployment, or additional valve implantation. All repositioning (n = 26) and retrieval (n = 6) attempts were successful; 34 patients (28.6%) received a permanent pacemaker. The primary device performance endpoint was met, because the mean gradient improved from 46.4 ± 15.0 mm Hg to 11.5 ± 5.2 mm Hg. At 30 days, the mortality rate was 4.2%, and the rate of disabling stroke was 1.7%; 1 (1.0%) patient had moderate PVR, whereas none had severe PVR. REPRISE II demonstrates the safety and effectiveness of the Lotus valve in patients with severe aortic stenosis who are at

  14. 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.

  15. Early- and mid-term outcomes after transcatheter aortic valve implantation. Data from a single-center registry

    PubMed Central

    Bagienski, Maciej; Dziewierz, Artur; Rzeszutko, Lukasz; Sorysz, Danuta; Trebacz, Jaroslaw; Sobczynski, Robert; Tomala, Marek; Stapor, Maciej; Gackowski, Andrzej; Dudek, Dariusz

    2016-01-01

    Introduction Transcatheter aortic valve implantation (TAVI) is a less invasive treatment option for elderly, high-risk patients with symptomatic severe aortic stenosis (AS) than aortic valve replacement. More importantly, TAVI improves survival and quality of life as compared to medical treatment in inoperable patients. Aim To assess early- and mid-term clinical outcomes after TAVI. Material and methods All consecutive high-risk patients with severe symptomatic AS undergoing TAVI from November 2008 to August 2014 were enrolled. The clinical and procedural characteristics, as well as clinical outcomes including mortality during 12-month follow-up, were assessed. Results A total of 101 consecutive patients underwent TAVI for native aortic valve stenosis (100%). Patients were elderly, with a median age of 81.0 (76.0–84.0) years, 60.4% were female and 83.2% presented with NYHA III/IV. Median baseline EuroSCORE I and STS scores were 14.0 (10.0–22.5)% and 12.0 (5.0–24.0)%, respectively. The main periprocedural and in-hospital complications were minor vascular complications, bleeding requiring blood transfusions, and the need for a permanent pacemaker. In-hospital, 30-day, 6-month and 12-month mortality rates were 6.9%, 10.9%, 15.8% and 17.8%, respectively. Conclusions A mortality rate of < 20% after 12 months seems acceptable given the high-risk population enrolled. PMID:27279871

  16. Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study.

    PubMed

    Linke, Axel; Wenaweser, Peter; Gerckens, Ulrich; Tamburino, Corrado; Bosmans, Johan; Bleiziffer, Sabine; Blackman, Daniel; Schäfer, Ulrich; Müller, Ralf; Sievert, Horst; Søndergaard, Lars; Klugmann, Silvio; Hoffmann, Rainer; Tchétché, Didier; Colombo, Antonio; Legrand, Victor M; Bedogni, Francesco; lePrince, Pascal; Schuler, Gerhard; Mazzitelli, Domenico; Eftychiou, Christos; Frerker, Christian; Boekstegers, Peter; Windecker, Stephan; Mohr, Friedrich-Wilhelm; Woitek, Felix; Lange, Rüdiger; Bauernschmitt, Robert; Brecker, Stephen

    2014-10-07

    Transcatheter aortic valve implantation has become an alternative to surgery in higher risk patients with symptomatic aortic stenosis. The aim of the ADVANCE study was to evaluate outcomes following implantation of a self-expanding transcatheter aortic valve system in a fully monitored, multi-centre 'real-world' patient population in highly experienced centres. Patients with severe aortic stenosis at a higher surgical risk in whom implantation of the CoreValve System was decided by the Heart Team were included. Endpoints were a composite of major adverse cardiovascular and cerebrovascular events (MACCE; all-cause mortality, myocardial infarction, stroke, or reintervention) and mortality at 30 days and 1 year. Endpoint-related events were independently adjudicated based on Valve Academic Research Consortium definitions. A total of 1015 patients [mean logistic EuroSCORE 19.4 ± 12.3% [median (Q1,Q3), 16.0% (10.3, 25.3%)], age 81 ± 6 years] were enrolled. Implantation of the CoreValve System led to a significant improvement in haemodynamics and an increase in the effective aortic valve orifice area. At 30 days, the MACCE rate was 8.0% (95% CI: 6.3-9.7%), all-cause mortality was 4.5% (3.2-5.8%), cardiovascular mortality was 3.4% (2.3-4.6%), and the rate of stroke was 3.0% (2.0-4.1%). The life-threatening or disabling bleeding rate was 4.0% (2.8-6.3%). The 12-month rates of MACCE, all-cause mortality, cardiovascular mortality, and stroke were 21.2% (18.4-24.1%), 17.9% (15.2-20.5%), 11.7% (9.4-14.1%), and 4.5% (2.9-6.1%), respectively. The 12-month rates of all-cause mortality were 11.1, 16.5, and 23.6% among patients with a logistic EuroSCORE ≤10%, EuroSCORE 10-20%, and EuroSCORE >20% (P< 0.05), respectively. The ADVANCE study demonstrates the safety and effectiveness of the CoreValve System with low mortality and stroke rates in higher risk real-world patients with severe aortic stenosis. Published on behalf of the European Society of Cardiology. All rights reserved

  17. First experience with transfemoral transcatheter aortic valve implantation without prior balloon pre-dilatation using a latest generation repositionable and retrievable transcatheter heart valve†.

    PubMed

    Schaefer, Andreas; Harmel, Eva; Seiffert, Moritz; Reichart, Daniel; Deuschl, Florian; Schofer, Niklas; Schneeberger, Yvonne; Blankenberg, Stefan; Reichenspurner, Hermann; Schaefer, Ulrich; Conradi, Lenard

    2017-05-01

    : The aim of this study was to prove technical feasibility and document haemodynamic and clinical outcomes of transcatheter aortic valve implantation (TAVI) with the latest generation repositionable and retrievable Lotus™ transcatheter heart valve (THV) without prior balloon-aortic valvuloplasty (BAV). It has been demonstrated for self-expandable and balloon-expandable THV that implantation without prior BAV is not only feasible and safe but also results in lower fluoroscopy times and amounts of contrast agent while yielding non-inferior haemodynamic and clinical outcome. To date no reports exist for TAVI without BAV for the Lotus™ THV. : A consecutive patient series received direct transfemoral (TF)-TAVI without prior BAV using the Lotus™ valve system. Baseline, intraprocedural and acute follow-up data up to 30 days were retrospectively collected. Clinical endpoints were adjudicated in accordance with the updated standardized Valve Academic Research Consortium (VARC)-2 definitions. : A total of 9 patients received direct TF-TAVI using the Lotus THV (77.7% female, 82.5 ± 5.3 years, logistic European System for Cardiac Operative Risk Evaluation I 14.2 ± 13.7%). Device success according to VARC-2 definitions was achieved in 100% (9/9) of the patients. Peak and mean transvalvular gradients as determined by transthoracic echocardiography prior to discharge decreased from 51.5 ± 17.3 to 24.4 ± 10.4 mmHg and 29.5 ± 9.6 to 13.2 ± 5.2 mmHg (both P  <   0.01). Effective orifice area increased from 0.9 ± 0.2 to 1.9 ± 0.3 cm 2 ( P  <   0.01). No paravalvular leakage (PVL) ≥ moderate was detected. All-cause 30-day mortality was 11.1% (1/9), with one death due to ischaemic enteritis. : In our series, TF-TAVI without prior BAV using this particular THV technical feasibility, no increased incidence of significant paravalvular leakage, and good haemodynamic and clinical outcome in selected patients. These results

  18. 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

  19. Comparison of Outcomes of Balloon-Expandable Versus Self-Expandable Transcatheter Heart Valves for Severe Aortic Stenosis.

    PubMed

    Wijeysundera, Harindra C; Qiu, Feng; Koh, Maria; Prasad, Treesa J; Cantor, Warren J; Cheema, Asim; Chu, Michael W A; Czarnecki, Andrew; Feindel, Christopher; Fremes, Stephen E; Kingsbury, Kori J; Natarajan, Madhu K; Peterson, Mark; Ruel, Marc; Strauss, Bradley; Ko, Dennis T

    2017-04-01

    Transcatheter aortic valve implantation (TAVI) is the treatment of choice for inoperable and high-risk patients with severe aortic stenosis. Our objectives were to elucidate potential differences in clinical outcomes and safety between balloon-expandable versus self-expandable transcatheter heart valves (THV). We performed a retrospective cohort study of all transfemoral TAVI procedures in Ontario, Canada, from 2007 to 2013. Patients were categorized into either balloon-expandable or self-expandable THV groups. The primary outcomes were 30-day and 1-year death, with secondary outcomes of all-cause readmission. Safety outcomes included bleeding, permanent pacemaker implantation, need for a second THV device, postprocedural paravalvular aortic regurgitation, stroke, vascular access complication, and intensive care unit length of stay. Inverse probability of treatment-weighted regression analyses using a propensity score were used to account for differences in baseline confounders. Our cohort consisted of 714 patients, of whom 397 received a self-expandable THV, whereas 317 had a balloon-expandable THV system. There were no differences in death or all-cause readmission. In terms of safety, the self-expandable group was associated with significantly higher rates of inhospital stroke (p value <0.05), need for a second THV device (5.3% vs 2.7%; p value = 0.013), and permanent pacemaker (22.6% vs 8.9%; p value <0.001), whereas the balloon-expandable group had more vascular access site complications (23.1% vs 16.7%; p value = 0.002). Thus, we found similar clinical outcomes of death or readmission for patients who underwent transfemoral TAVI with either balloon-expandable or self-expandable THV systems. However, there were important differences in their safety profiles.

  20. Quality of life after transcatheter aortic valve implantation and surgical replacement in high-risk elderly patients.

    PubMed

    Kala, Petr; Tretina, Martin; Poloczek, Martin; Ondrasek, Jiri; Malik, Petr; Pokorny, Petr; Parenica, Jiri; Spinar, Jindrich; Jarkovsky, Jiri; Littnerova, Simona; Nemec, Petr

    2013-03-01

    The aim of this study was to compare the quality of life after transcatheter aortic valve implantation (TAVI) and surgical replacement (SAVR) at one year. The study included 45 consecutive high-risk patients (average age 82.0 years; logistic Euroscore 22.3%) with symptomatic severe aortic stenosis allocated to TAVI transfemoral, TAVI transapical using the Edwards-Sapien valve or SAVR with the Edwards Perimount bioprosthesis (n=15 in each). The pre-operative characteristics were similar except for more myocardial infarctions in TAVI. The quality of life was assessed using the standardized EQ-5D questionnaire at baseline and on days 30, 90 and 360. The protocol was approved by the local ethics committee and an informed consent was signed. A total of 7 patients (15.5%) died during follow-up. At baseline no significant differences in any of the quality-of-life parameters were found except for usual activities described as "best" (46.7% in SAVR vs. 10.0% in TAVI; P=0.002). At 30 and 90 days surviving patients were similar and at 360 days only the anxiety/depression score was "best" in 83.3% SAVR vs. 59.1% (P=0.046). Functional status improved in all patients (NYHA class I-II in 13.3% at baseline vs. 78.9% at 360-days) and the general health median significantly improved in TAVI patients (from 50 to 67; P=0.001) with a positive trend in SAVR patients (P=0.060). At one year, the general quality of life of high-risk patients had significantly improved after transcatheter aortic valve implantation with a positive trend in surgically treated patients.

  1. Vascular Complications and Bleeding After Transfemoral Transcatheter Aortic Valve Implantation Performed Through Open Surgical Access.

    PubMed

    Leclercq, Florence; Akodad, Mariama; Macia, Jean-Christophe; Gandet, Thomas; Lattuca, Benoit; Schmutz, Laurent; Gervasoni, Richard; Nogue, Erika; Nagot, Nicolas; Levy, Gilles; Maupas, Eric; Robert, Gabriel; Targosz, Frederic; Vernhet, Hélène; Cayla, Guillaume; Albat, Bernard

    2015-11-01

    Major vascular complications (VC) remain frequent after transcatheter aortic valve implantation (TAVI) and may be associated with unfavorable clinical outcomes. The objective of this study was to evaluate the rate of VC after transfemoral TAVI performed using an exclusive open surgical access strategy. From 2010 to 2014, we included in a monocentric registry all consecutive patients who underwent transfemoral TAVI. The procedures were performed with 16Fr to 20Fr sheath systems. VC were evaluated within 30 days and classified as major or minor according to the Valve Academic Research Consortium 2 definition. The study included 396 patients, 218 were women (55%), median age was 85 years (81 to 88), and the median logistic Euroscore was 15.2% (11 to 23). The balloon-expandable SAPIEN XT and the self-expandable Medtronic Core Valve prosthesis were used in 288 (72.7%) and 108 patients (27.3%), respectively. The total length of the procedure was 68 ± 15 minutes including 13 ± 5 minutes for the open surgical access. Major and minor VC were observed in 9 (2.3%) and 16 patients (4%), respectively, whereas life-threatening and major bleeding concerned 18 patients (4.6%). The median duration of hospitalization was 5 days (interquartile range 2 to 7), significantly higher in patients with VC (7 days [5 to 15], p <0.001). Mortality at 1-month and 1-year follow-up (n = 26, 6.6%; and n = 67, 17.2%, respectively) was not related to major or minor VC (p = 0.6). In multivariable analysis, only diabetes (odds ratio 2.5, 95% confidence interval 1.1 to 6.1, p = 0.034) and chronic kidney failure (odds ratio 3.0, 95% confidence interval 1.0 to 9.0, p = 0.046) were predictive of VC, whereas body mass index, gender, Euroscore, and lower limb arteriopathy were not. In conclusion, minimal rate of VC and bleeding can be obtained after transfemoral TAVI performed using an exclusive surgical strategy, with a particular advantage observed in high-risk bleeding patients.

  2. Frailty is associated with delirium and mortality after transcatheter aortic valve implantation

    PubMed Central

    Assmann, Patricia; Kievit, Peter; van der Wulp, Kees; Verkroost, Michel; Noyez, Luc; Bor, Hans; Schoon, Yvonne

    2016-01-01

    Objective We hypothesised that frailty assessment is of additional value to predict delirium and mortality after transcatheter aortic valve implantation (TAVI). Methods Observational study in 89 consecutive patients who underwent TAVI. Inclusion from November 2012 to February 2014, follow-up until April 2014. Measurement of the association of variables from frailty assessment and cardiological assessment with delirium and mortality after TAVI, respectively. Results Incidence of delirium after TAVI: 25/89 (28%). Variables from frailty assessment protectively associated with delirium were: Mini Mental State Examination, (OR 0.79; 95% CI 0.65 to 0.96; p=0.02), Instrumental Activities of Daily Living (OR 0.79; 95% CI 0.63 to 0.99; p=0.04) and gait speed (OR 0.05; 95% CI 0.01 to 0.50; p=0.01). Timed Up and Go was predictively associated with delirium (OR 1.14; 95% CI 1.03 to 1.26; p=0.01). From cardiological assessment, pulmonary hypertension was protectively associated with delirium (OR 0.34; 95% CI 0.12 to 0.98; p=0.05). Multivariate logistic analysis: Nagelkerke R2=0.359, Mini Mental State Examination was independently associated with delirium. Incidence of mortality: 11/89 (12%). Variables predictively associated with mortality were: the summary score Frailty Index (HR 1.66, 95% CI 1.06 to 2.60; p=0.03), European System for Cardiac Operative Risk Evaluation (EuroSCORE) II (HR 1.14, 95% CI 1.06 to 1.22; p<0.001) and complications (HR 4.81, 95% CI 1.03 to 22.38; p=0.05). Multivariate Cox proportional hazards analysis: Nagelkerke R2=0.271, Frailty Index and EuroSCORE II were independently associated with mortality. Conclusions Delirium frequently occurs after TAVI. Variables from frailty assessment are associated with delirium and mortality, independent of cardiological assessment. Thus, frailty assessment may have additional value in the prediction of delirium and mortality after TAVI. PMID:28008356

  3. Clinical and prognostic implications of atrial fibrillation in patients undergoing transcatheter aortic valve implantation

    PubMed Central

    Salinas, Pablo; Moreno, Raúl; Calvo, Luis; Jiménez-Valero, Santiago; Galeote, Guillermo; Sánchez-Recalde, Angel; López-Fernández, Teresa; Garcia-Blas, Sergio; Iglesias, Diego; Riera, Luis; Moreno-Gómez, Isidro; Mesa, Jose María; Plaza, Ignacio; Ayala, Rocio; Gonzalez, Rosa; López-Sendón, José-Luis

    2012-01-01

    AIM: To study a cohort of consecutive patients undergoing transcatheter aortic valve implantation (TAVI) and compare the outcomes of atrial fibrillation (AF) patients vs patients in sinus rhythm (SR). METHODS: All consecutive patients undergoing TAVI in our hospital were included. The AF group comprised patients in AF at the time of TAVI or with history of AF, and were compared with the SR group. Procedural, echocardiographic and follow-up variables were compared. Likewise, the CHA2DS2-VASC stroke risk score and HAS-BLED bleeding risk score and antithrombotic treatment at discharge in AF patients were compared with that in SR patients. RESULTS: From a total of 34 patients undergoing TAVI, 17 (50%) were allocated to the AF group, of whom 15 (88%) were under chronic oral anticoagulation. Patients in the AF group were similar to those in the SR group except for a trend (P = 0.07) for a higher logistic EuroSCORE (28% vs 19%), and a higher prevalence of hypertension (82% vs 53%) and chronic renal failure (17% vs 0%). Risk of both stroke and bleeding was high in the AF group (mean CHA2DS2-VASC 4.3, mean HAS-BLED 2.9). In the AF group, treatment at discharge included chronic oral anticoagulation in all except one case, and in association with an antiplatelet drug in 57% of patients. During a mean follow-up of 11 mo (maximum 32), there were only two strokes, none of them during the peri-procedural period: one in the AF group at 30 mo and one in the SR group at 3 mo. There were no statistical differences in procedural success, and clinical outcome (survival at 1 year 81% vs 74% in AF and SR groups, respectively, P = NS). CONCLUSION: Patients in AF undergoing TAVI show a trend to a higher surgical risk. However, in our cohort, patients in AF did not have a higher stroke rate compared to the SR group, and the prognosis was similar in both groups. PMID:22279599

  4. In-hospital and mid-term predictors of mortality after transcatheter aortic valve implantation: data from the TAVI National Registry 2010-2011.

    PubMed

    Sabaté, Manel; Cánovas, Sergio; García, Eulogio; Hernández Antolín, Rosana; Maroto, Luis; Hernández, José María; Alonso Briales, Juan H; Muñoz García, Antonio J; Gutiérrez-Ibañes, Enrique; Rodríguez-Roda, Jorge

    2013-12-01

    The treatment of severe symptomatic aortic stenosis has been revolutionized by the technique of transcatheter valve replacement. The purpose of this study was to present the outcomes and predictors of mortality in patients enrolled between 2010 and 2011 in the Transcatheter Aortic Valve Replacement National Registry. We collected 131 preprocedural, 31 periprocedural, and 76 follow-up variables, and analyzed the immediate implant success rate, the 30-day safety endpoint, and all-cause 30-day and mid-term (mean follow-up, 244 days) mortality. From January 2010 to December 2011, a total of 1416 patients were included: 806 with Edwards valves and 610 with CoreValves. The implant success and 30-day mortality rates were 94% and 8%, respectively, without differences between types of valves and approaches. The 30-day safety endpoint and mid-term mortality rates were 14% and 16%, respectively, which were also similar between groups. The presence of comorbidities (renal failure, peripheral vascular disease, ejection fraction, and atrial fibrillation), the need for conversion to surgery, and at least moderate aortic regurgitation after transcatheter aortic valve implantation were identified as independent predictors of in-hospital and mid-term mortality. The prognosis of valve implant patients could be improved by including comorbidities in patient selection and by minimizing the degree of residual aortic regurgitation to optimize the results of the procedure. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  5. The Ibero-American transcatheter aortic valve implantation registry with the CoreValve prosthesis. Early and long-term results.

    PubMed

    Muñoz-García, Antonio J; del Valle, Raquel; Trillo-Nouche, Ramiro; Elízaga, Jaime; Gimeno, Federico; Hernández-Antolín, Rosana; Teles, Rui; de Gama Ribeiro, Vasco; Molina, Eduardo; Cequier, Angel; Urbano-Carrillo, Cristóbal; Cruz-González, Ignacio; Payaslian, Miguel; Patricio, Lino; Sztejfman, Matías; Iñiguez, Andrés; Rodríguez, Víctor; Scuteri, Antonio; Caorsi, Carlos; López-Otero, Diego; Avanzas, Pablo; Alonso-Briales, Juan H; Hernández-García, José M; Morís, César

    2013-11-20

    Transcatheter aortic valve implantation (TAVI) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The aim of this study was to describe early experience and long-term follow-up with the CoreValve self-expanding aortic prosthesis at 42 Ibero-American hospitals. Multiple centre observational study including 1220 consecutive patients with symptomatic severe aortic stenosis who are not suitable candidates for surgery and underwent transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System between December 2007 and May 2012. The registry included 1220 consecutive patients with a mean age of 80.8 ± 6.3 years and a mean logistic euroSCORE of 17.8% ± 13%. The procedural success rate was 96.1%. Hospital mortality was 7.3% and combined end-point was 21.3%. Aortic regurgitation after TAVI was present in 24.5% (Sellers grade ≥ 2). The estimated 1-year and 2-year survival rates were 82.1% and 73.4% respectively. The following issues were significant independent risk factors for hospital mortality: acute kidney failure (odds ratio 3.55); stroke (odds ratio 5.72); major bleeding (odds ratio 2.64) and euroSCORE (odds ratio 1.02). Long-term predictors of mortality were diabetes mellitus (hazard ratio 1.59, 95% confidence interval 1.09-2.31), severe chronic obstructive pulmonary disease (hazard ratio 1.85, 95% confidence interval 1.85-2.88), and functional classes NYHA III-IV (hazard ratio 1.31, 95% confidence interval 1.01-1.70). Transcatheter aortic valve implantation constitutes a safe and viable therapeutic option for high operative risk patients with severe aortic stenosis. Long-term prognosis is conditioned by associate comorbidities. © 2013.

  6. 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.

  7. Impact of aortic valve calcification severity and impaired left ventricular function on 3-year results of patients undergoing transcatheter aortic valve replacement.

    PubMed

    Koos, Ralf; Reinartz, Sebastian; Mahnken, Andreas Horst; Herpertz, Ralf; Lotfi, Shahram; Autschbach, Rüdiger; Marx, Nikolaus; Hoffmann, Rainer

    2013-12-01

    To evaluate clinical pre-interventional predictors of 3-year outcome and mortality in high-risk patients with severe aortic valve stenosis treated with transcatheter aortic valve implantation (TAVI). Among 367 patients included in the Aachen TAVI registry, 76 patients with baseline dual-source computed tomography (DSCT) for the quantification of aortic valve calcification (AVC) and a 3-year follow-up were identified. Survival at 30 days was 91 %, and it was 75 %, 66 % and 64 % at 1, 2 years and 3 years, respectively. Non-survivors at 3 years showed a significantly higher Agatston AVC score (2,854 ± 1,651) than survivors (1,854 ± 961, P = 0.007). Multivariate analysis including age, logistic EuroScore, glomerular filtration rate, Agatston AVC score, ejection fraction < 40 %, NYHA class, baseline medication, chronic lung disease and aortic regurgitation revealed that only the Agatston AVC score (P = 0.03) and impaired left ventricular function (P = 0.001) was significantly associated with mortality. Patients with Agatston AVC scores >2,000 had a significantly lower 3-year survival rate compared with patients with scores <2,000 (47 % vs 79 %, P = 0.004). In patients referred for TAVI, aortic valve calcification severity and impaired left ventricular function may serve as a predictor of long-term mortality. Therefore, AVC scores easily determined from pre-procedural CT datasets may be used for patient risk stratification.

  8. Comparison of the effectiveness of transcatheter aortic valve implantation in patients with stenotic bicuspid versus tricuspid aortic valves (from the German TAVI Registry).

    PubMed

    Bauer, Timm; Linke, Axel; Sievert, Horst; Kahlert, Philipp; Hambrecht, Rainer; Nickenig, Georg; Hauptmann, Karl Eugen; Sack, Stefan; Gerckens, Ulrich; Schneider, Steffen; Zeymer, Uwe; Zahn, Ralf

    2014-02-01

    Patients with bicuspid aortic valves (BAVs) are considered a relative contraindication to transcatheter aortic valve implantation (TAVI). One of the main reasons is the presumed risk for residual aortic regurgitation (AR). However, case reports and small case series have suggested that TAVI can be successfully performed with acceptable clinical outcomes in high-risk patients with BAV. Within the large German TAVI Registry, we sought to evaluate TAVI in older high-risk patients with BAV. From January 2009 to June 2010, a total of 1,424 patients with severe aortic stenosis undergoing TAVI were prospectively enrolled into the German TAVI Registry. For the present analysis, patients with valve-in-valve procedures were excluded and those with BAV (n = 38, 3%) were compared with those with tricuspid aortic valve (TAV; n = 1357, 97%). Patient characteristics did not markedly differ and procedural success was very high in both groups. There was a higher rate of relevant AR (≥II) after TAVI among patients with BAV (25 vs 15%, p = 0.05), whereas pacemakers were more often implanted in patients with TAV (17% vs 35%, p = 0.02). Thirty-day mortality rate was similar in both cohorts (11% vs 11%). In a Cox proportional regression analysis, BAV was not associated with higher 1-year mortality rate (hazard ratio 0.64, 95% confidence interval 0.29 to 1.41). In selected patients with BAV, TAVI can be performed with a satisfactory clinical result. Although the risk for relevant AR seems to be greater among patients with BAV, 30-day and 1-year mortality rates were not elevated compared with patients with TAV.

  9. Intravenous Recombinant Tissue Plasminogen Activator Therapy for Acute Basilar Artery Ischemic Stroke Following Transfemoral Transcatheter Aortic Valve Implantation.

    PubMed

    Montarello, Nicholas J; Nelson, Adam J; Sidharta, Samuel L; Worthley, Stephen G

    2016-01-01

    Transcatheter aortic valve implantation (TAVI) can now be considered a standard of care for inoperable and high-risk surgical patients with severe aortic stenosis, and its uptake worldwide is rapidly increasing. Indeed, many centers performing the procedure have now moved towards treating intermediate-risk patients with TAVI rather than referring them for surgical aortic valve replacement. Although the incidence of peri-procedural acute and subacute stroke following TAVI has fallen to 2-5%, its occurrence can be life-threatening and life-changing, and every effort must be made to improve patient outcome should stroke occur. Many cardiologists would not instinctively consider the use of thrombolytic therapy for post-transfemoral TAVI ischemic stroke because of concern about the risk of major bleeding from the access site, despite it being a standard of care for ischemic stroke in other circumstances. The present case highlights the benefit of using intravenous thrombolytic therapy for an acute basilar artery thrombotic stroke after transfemoral TAVI (TF-TAVI) that would otherwise have almost certainly resulted in the patient's death. The case may also prompt interventional cardiologists to consider performing TF-TAVI under conscious sedation rather than general anesthesia, as this can result in an earlier detection of acute stroke and allow an earlier intervention with thrombolytic agents, with an improved outcome.

  10. POL-TAVI – Polish Registry of Transcatheter Aortic Valve Implantation – simple tool, great value, rationale and design

    PubMed Central

    Wilczek, Krzysztof; Tobota, Zdzisław; Chodór, Piotr; Cieśla, Daniel; Jaźwiec, Tomasz; Banasiak, Waldemar; Stępińska, Janina; Kalarus, Zbigniew; Opolski, Grzegorz; Zembala, Marian

    2016-01-01

    Aortic stenosis (AS) is the most common valvular heart disease in adults in Europe and North America. Management of AS patients depends on accurate diagnosis of the cause and stage of the disease process: the first and definitive therapeutic choice for a growing number of elderly patients with symptomatic AS is surgical treatment. In patients not eligible for surgery, transcatheter aortic valve implantation (TAVI) constitutes a safe and effective alternative. As an innovative, costly method of treatment, it requires however careful monitoring of its course, documenting its early and long-term results, and assessment of its safety and medical-economic cost-effectiveness. A medical registry seems to be an excellent tool to perform such analysis. The aim of this paper is to present the design and rationale for creation of the first National Cardiac-Cardiac Surgical Registry of Percutaneous Aortic Valve Treatment POL-TAVI, to describe its genesis and to highlight its key assumptions and aims. Despite its recent beginnings, the POL-TAVI Registry has already demonstrated its value and usability in monitoring and assessment of TAVI procedures, leading to further improvement and development of this new method in Poland. It constitutes an important and valuable tool for patients, the medical community and the payer. PMID:28096826

  11. POL-TAVI - Polish Registry of Transcatheter Aortic Valve Implantation - simple tool, great value, rationale and design.

    PubMed

    Zembala-John, Joanna; Wilczek, Krzysztof; Tobota, Zdzisław; Chodór, Piotr; Cieśla, Daniel; Jaźwiec, Tomasz; Banasiak, Waldemar; Stępińska, Janina; Kalarus, Zbigniew; Opolski, Grzegorz; Zembala, Marian

    2016-12-01

    Aortic stenosis (AS) is the most common valvular heart disease in adults in Europe and North America. Management of AS patients depends on accurate diagnosis of the cause and stage of the disease process: the first and definitive therapeutic choice for a growing number of elderly patients with symptomatic AS is surgical treatment. In patients not eligible for surgery, transcatheter aortic valve implantation (TAVI) constitutes a safe and effective alternative. As an innovative, costly method of treatment, it requires however careful monitoring of its course, documenting its early and long-term results, and assessment of its safety and medical-economic cost-effectiveness. A medical registry seems to be an excellent tool to perform such analysis. The aim of this paper is to present the design and rationale for creation of the first National Cardiac-Cardiac Surgical Registry of Percutaneous Aortic Valve Treatment POL-TAVI, to describe its genesis and to highlight its key assumptions and aims. Despite its recent beginnings, the POL-TAVI Registry has already demonstrated its value and usability in monitoring and assessment of TAVI procedures, leading to further improvement and development of this new method in Poland. It constitutes an important and valuable tool for patients, the medical community and the payer.

  12. [From FRANCE 2 to FRANCE TAVI: are indications, technique and results of transcatheter aortic valve replacement the same?].

    PubMed

    Auffret, Vincent; Bedossa, Marc; Boulmier, Dominique; Verhoye, Jean Philippe; Ruggieri, Vito Giovanni; Koning, René; Laskar, Marc; Van Belle, Éric; Leprince, Pascal; Collet, Jean Philippe; Iung, Bernard; Lefèvre, Thierry; Eltchaninoff, Helene; Gilard, Martine; Le Breton, Hervé

    2015-01-01

    Transcatheter aortic valve implantation (TAVI) is indicated in patients with severe symptomatic aortic stenosis who are not suitable for surgery or should be considered when there is a high surgical risk as assessed by a heart team. There is a decrease in mean logistic EuroSCORE since January 2010, which translates a gradual evolution in patients' selection. Expertise of geriatricians to further assess frailty is a key step in the risk stratification process of this elderly population (mean age: 83.4±7.3 years). Femoral access is used in 80% of cases with a procedural success rate higher than 95%. In-hospital mortality rate is 5.9%. The main complications of the procedure are aortic annulus rupture (0.9% in FRANCE TAVI), tamponade (2.3%), stroke (2.2%), severe paravalvular leak (1.3%) and permanent pacemaker implantation (15%). The awaited results of PARTNER II and SURTAVI may lead to expand the indications to lower-risk patients if it is shown that TAVI is non-inferior to surgery in this population which has been suggested by the recent randomized NOTION Trial while the CoreValve Pivotal Trial even points in the direction of a possible superiority of the percutaneous technique over surgery.

  13. Considerations and Recommendations for the Introduction of Objective Performance Criteria for Transcatheter Aortic Heart Valve Device Approval.

    PubMed

    Head, Stuart J; Mylotte, Darren; Mack, Michael J; Piazza, Nicolo; van Mieghem, Nicolas M; Leon, Martin B; Kappetein, A Pieter; Holmes, David R

    2016-05-24

    In the United States, new surgical heart valves can be approved on the basis of objective performance criteria (OPC). In contrast, the US Food and Drug Administration traditionally requires stricter criteria for transcatheter heart valve (THV) approval, including randomized, clinical trials. Recent US Food and Drug Administration approval of new-generation THVs based on single-arm studies has generated interest in alternative study approaches for THV device approval. This review evaluates whether THV device approval could follow a pathway analogous to that of surgical heart valves by incorporating OPC and provides several considerations and recommendations. Factors to be taken into account in the construction of OPC include the maturity of THV technology, variability in transcatheter aortic valve replacement practice, end points included as OPC, follow-up terms for specific OPC, patient populations to which these OPC apply, and (statistical) methods for OPC development. We recommend that approval of THV devices in the United States for low- and intermediate-risk patients or for new indications should provisionally rely on data from randomized, clinical trials. However, it is recommended that formal OPC be applied for approval of new-generation THVs for use in high- and extreme-risk patient populations. © 2016 American Heart Association, Inc.

  14. Transcatheter Aortic Valve Replacement: The New Standard in Patients With Previous Coronary Bypass Grafting?

    PubMed

    Reinöhl, Jochen; Kaier, Klaus; Reinecke, Holger; Frankenstein, Lutz; Zirlik, Andreas; Zehender, Manfred; von Zur Mühlen, Constantin; Bode, Christoph; Stachon, Peter

    2016-10-24

    The aim of this study was to assess how the introduction of transcatheter aortic valve replacement (TAVR) has changed clinical practice and outcome in patients who have previously undergone coronary artery bypass grafting (CABG). A significant proportion of patients admitted for aortic valve replacement have previously undergone CABG and are therefore at increased operative risk in case of redo surgery. In-hospital outcome data were analyzed from patients with or without previous CABG undergoing isolated surgical aortic valve replacement or TAVR in Germany from 2007 to 2013. In total, 32,581 TAVR and 55,992 surgical aortic valve replacement procedures were performed in patients with (n = 6,221) or without (n = 82,352) previous CABG. TAVR increased markedly in patients with previous CABG, from 18 procedures in 2007 to 1,191 in 2013, while surgical aortic valve replacement decreased in these patients from 471 to 179 procedures. In 2013, TAVR was the preferred therapy in almost 90% of patients with previous CABG. In-hospital mortality was increased in patients with previous CABG compared with those without (7.6% vs. 6.3% for TAVR and 7.2% vs. 2.6% for surgical aortic valve replacement). Bleeding and stroke rates were also increased with redo surgical aortic valve replacement procedures (with vs. without previous CABG: stroke, 3.2% vs. 1.8%; relevant bleeding, 29.6% vs. 13.4%; acute kidney injury, 4.2% vs. 2.9%), whereas this was not the case with TAVR (stroke, 2.1% vs. 2.6%; relevant bleeding, 7.3% vs. 8.3%; acute kidney injury, 6.3% vs. 5.4% respectively). A similar influence was seen in resource utilization (discharge destination home: TAVR after CABG, 51%; surgical aortic valve replacement after CABG, 31%). Since its introduction in 2007, TAVR has been increasingly used in Germany in patients with previous CABG, and in-hospital outcome data support the trend away from redo surgery. Copyright © 2016 American College of Cardiology Foundation. Published by

  15. Transcatheter aortic valve replacement: establishing a comprehensive program model for hybrid cardiac catheterization laboratories in the Department of Veterans Affairs.

    PubMed

    Speiser, Bernadette; Dutra-Brice, Cynthia

    2014-01-01

    Aortic valve disease, especially aortic stenosis, becomes progressively debilitating and carries a high mortality risk if it is categorized as severe and symptomatic (J Thorac Cardiovas Surg. 2012;144(3):e29-e84). In the past, the only treatment for aortic stenosis was surgical aortic valve replacement. Surgical treatment may require several hours of cardioplegia, and if the patient has comorbidities, such as renal failure or chronic obstructive pulmonary disease, their operative mortality percentage increases.In 2011, the US Food and Drug Administration approved the use of a transcatheter aortic valve replacement (TAVR) procedure for patients who were deemed high risk or inoperative for the routine surgical aortic valve replacement surgery. More than 20, 000 TAVRs have been performed in patients worldwide since 2002 when Dr Alain Cribier performed the first-in-man TAVR (Arch Cardiovasc Dis. 2012;105(3):145-152). The Edwards Lifesciences SAPIEN XT valve and the Medtronic CoreValve are commercially available.The clinical findings and economic statistic have supported the expansion of the TAVR procedure. However, there has been considerable controversy over where the procedure is to occur and who is directly responsible for directing the TAVR care. This debate has identified barriers to the implementation of a TAVR program. The operating rooms and a cardiac catheterization laboratory are underprepared for the hybrid valve replacement therapy. Because of the barriers identified, the Department of Veterans Affairs determined a need for a systematic approach to review the programs that applied for this structural heart disease program. A centralized team was developed to ensure room readiness and staff competency. The use of the Health Failure Mode and Effects Analysis can define high-risk clinical processes and conduct a hazard analysis. Worksheets can show potential failure modes and their probabilities, along with actions and outcome measures, team collaboration

  16. Quality-of-Life Outcomes After Transcatheter Aortic Valve Replacement in an Unselected Population: A Report From the STS/ACC Transcatheter Valve Therapy Registry.

    PubMed

    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

    2017-04-01

    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, evaluation of the health status outcomes among unselected patients treated with TAVR is of critical importance. To examine the short- and long-term health status outcomes of surviving patients after TAVR in the context of an unselected population. This observational cohort study included patients with severe aortic stenosis who underwent TAVR in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry from November 1, 2011, to March 31, 2016, at more than 450 clinical sites. Disease-specific health status was assessed at baseline and at 30 days and 1 year after TAVR using the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score (range, 0-100 points; higher scores indicate less symptom burden and better quality of life). Factors associated with health status at 1 year after TAVR were examined using multivariable linear regression, with adjustment for baseline health status and accounting for clustering of patients within sites. The 30-day analytic sample included 31 636 patients, and the 1-year cohort included 7014 surviving patients (3454 women [49.2%] and 3560 men [50.8%]; median [interquartile range] age, 84 [78-88] years). The mean (SD) baseline KCCQ-OS score 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 score of 27.6 (95% CI, 27.3-27.9) points at 30 days and 31.9 (95% CI, 31.3-32.6) points at 1 year. Worse baseline health status, older age, higher ejection fraction, lung disease, home oxygen use, lower mean aortic valve gradients, prior stroke, diabetes, pacemaker use, atrial fibrillation, slow gait speed, and nonfemoral access were significantly

  17. Atrial Fibrillation Is Associated With Increased Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement: Insights from the PARTNER Trial

    PubMed Central

    Biviano, Angelo B.; Nazif, Tamim; Dizon, Jose; Garan, Hasan; Fleitman, Jessica; Hassan, Dua; Kapadia, Samir; Babaliaros, Vasilis; Xu, Ke; Parvataneni, Rupa; Rodes-Cabau, Josep; Szeto, Wilson Y.; Fearon, William F.; Dvir, Danny; Dewey, Todd; Williams, Mathew; Mack, Michael J.; Webb, John G.; Miller, D. Craig; Smith, Craig R.; Leon, Martin B.; Kodali, Susheel

    2015-01-01

    Background This study sought to evaluate the impact of atrial fibrillation (AF) on clinical outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). Methods and Results Data were evaluated in 1879 patients with baseline and discharge ECGs who underwent TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve) Trial. A total of 1262 patients manifested sinus rhythm (SR) at baseline/SR at discharge, 113 SR baseline/AF discharge, and 470 AF baseline/AF discharge. Patients who converted from SR to AF by discharge had the highest rates of all-cause mortality at 30 days (p<0.0001 across all groups; 14.2% SR/AF vs. 2.6% SR/SR; adjusted HR=3.41 p=0.0002) and over two-fold difference at 1-year (p<0.0001 across all groups; 35.7% SR/AF vs. 15.8% SR/SR; adjusted HR=2.14, p<0.0001). The presence of AF on baseline and/or discharge ECG was a predictor of 1-year mortality (adjusted HR=2.14 for SR/AF group and HR=1.88 for AF/AF groups, p<0.0001 for both groups vs. SR/SR). For patients discharged in AF, those with lower ventricular response (i.e, <90 bpm) experienced less 1-year all-cause mortality (HR=0.74, p=0.04). Conclusions After TAVR, the presence of AF at discharge, and particularly the conversion to AF by discharge and higher ventricular response, are associated with increased mortality. These data underscore the deleterious impact of AF, as well as the need for targeted interventions to improve clinical outcomes, in patients undergoing TAVR. PMID:26733582

  18. Midterm clinical outcome following Edwards SAPIEN or Medtronic Corevalve transcatheter aortic valve implantation (TAVI): Results of the Belgian TAVI registry.

    PubMed

    Collas, Valérie M; Dubois, Christophe; Legrand, Victor; Kefer, Joëlle; De Bruyne, Bernard; Dens, Jo; Rodrigus, Inez E; Herijgers, Paul; Bosmans, Johan M

    2015-09-01

    To assess midterm (3 years) clinical outcomes of transcatheter aortic valve implantation (TAVI) in Belgium using the Edwards SAPIEN valve or the Medtronic CoreValve transcatheter heart valve (THV). Medium and long term follow-up data of both THVs are still relatively scarce, although of great clinical relevance for a relatively new but rapidly expanding treatment modality. Therefore, reporting mid- and long term clinical outcome data, coming from large "real world" national registries, remains contributive. Between December 2007 and March 2012, 861 "real world" patients who were not candidates for surgical aortic valve replacement as decided by the local heart teams, underwent TAVI at 23 sites. Eleven sites exclusively used SAPIEN THV (n = 460), while 12 exclusively used CoreValve THV (n = 401). Differences in clinical outcomes by valve system were assessed, according to access route and baseline EuroSCORE risk profile (<10%: low, 10-20%: intermediate and >20%: high risk). Overall cumulative survival at 3 years was 51% for SAPIEN vs. 60% for CoreValve (P = 0.021). In transfemorally treated patients, SAPIEN and CoreValve had similar survival at 3 years for each of the baseline EuroSCORE cohorts (low risk: 72% vs. 76%, P = 0.45; intermediate risk: 62% vs. 59%, P = 0.94; high risk: 48% vs. 53%, P = 0.65). Cumulative midterm 3 year survival after transfemoral TAVI in "real world" patients refused for surgery with similar baseline EuroSCORE risk profile is not different between SAPIEN or CoreValve. © 2015 Wiley Periodicals, Inc.

  19. 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.

  20. 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!

  1. Emergency use of cardiopulmonary bypass in complicated transcatheter aortic valve replacement: importance of a heart team approach.

    PubMed

    Roselli, Eric E; Idrees, Jay; Mick, Stephanie; Kapadia, Samir; Tuzcu, Murat; Svensson, Lars G; Lytle, Bruce W

    2014-10-01

    Transcatheter aortic valve replacement (TAVR) expands options for high-risk patients with aortic stenosis but is complex with life-threatening complications. We describe indications for use of salvage cardiopulmonary bypass (CPB) and assess outcomes. From 2006 to 2011, 303 patients underwent TAVR, and 12 (4%) required emergency CPB. Approach was transapical (9) and transfemoral (3). Mean age was 82±9 years, median Society of Thoracic Surgeons score was 11 and mean gradient was 46±9 mm Hg. Access for CPB was femoral under fluoroscopy. Principal indication for CPB was hemodynamic instability with or without ischemic changes. These resulted from aortic insufficiency (n=5), valve embolization (n=3), coronary malperfusion (n=2), bleeding requiring pericardiocentesis (n=1), and bleeding from ventricular apex (n=1). Additional procedures included valve-in-valve TAVR (n=5), surgical valve replacement (n=3), and coronary intervention (n=2). Additional circulatory support was used in 7 cases: intra-aortic balloon pump (5) and extracorporeal membrane oxygenation (3). There were 2 hospital deaths. Mean postoperative gradient was 12±9 mm Hg, and median stay was 16 days. There were no myocardial infarctions or renal failure. One patient had stroke with arm weakness, 2 required tracheostomy, and 2 underwent reoperations for bleeding. Median follow-up was 19 months, and there were 5 late deaths. Complications during TAVR can be life threatening and may necessitate additional procedures. Expeditious use of CPB support provided by a multidisciplinary heart team optimizes rescue after myocardial collapse. Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  2. Extended contrast detection on fluoroscopy and angiography for image-guided trans-catheter aortic valve implantations (TAVI)

    NASA Astrophysics Data System (ADS)

    Liu, Yinxiao; Liao, Rui; Lv, Xudong

    2012-02-01

    Navigation and deployment of the prosthetic valve during trans-catheter aortic valve implantation (TAVI) can be greatly facilitated with 3-D models showing detailed anatomical structures. Fast and robust automatic contrast detection at the aortic root on X-ray images is indispensable for automatically triggering a 2-D/3-D registration to align the 3-D model. Previously, we have proposed an automatic method for contrast detection at the aortic root on fluoroscopic and angiographic sequences [4]. In this paper, we extend that algorithm in several ways, making it more robust to handle more general and difficult cases. Specifically, the histogram likelihood ratio test is multiplied with the histogram portion computation to handle faint contrast cases. Histogram mapping corrects sudden changes in the global brightness, thus avoiding potential false positives. Respiration and heart beating check further reduces the false positive rate. In addition, a probe mask is introduced to enhance the contrast feature curve when the dark ultrasound probe partially occludes the aortic root. Lastly, a semi-global registration method for aligning the aorta shape model is implemented to improve the robustness of the algorithm with respect to the selection of region of interest (ROI) containing the aorta. The extended algorithm was evaluated on 100 sequences, and improved the detection accuracy from 94% to 100%, compared to the original method. Also, the robustness of the extended algorithm was tested with 20 different shifts of the ROI, and the error rate was as low as 0.2%, in comparison to 6.6% for the original method.

  3. Hospital Practice of Direct-Home Discharge and 30-Day Readmission After Transcatheter Aortic Valve Replacement in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry.

    PubMed

    Dodson, John A; Williams, Mathew R; Cohen, David J; Manandhar, Pratik; Vemulapalli, Sreekanth; Blaum, Caroline; Zhong, Hua; Rumsfeld, John S; Hochman, Judith S

    2017-08-21

    Nearly 17% of patients are readmitted within 30 days of discharge after transcatheter aortic valve replacement. Selected patients are discharged to skilled nursing facilities, yet the association between a hospital's practice to discharge home versus to skilled nursing facilities, and readmission remains unclear. The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry was used to evaluate readmissions among patients undergoing transcatheter aortic valve replacement (2011-2015). Hospitals were divided into quartiles (Q1-Q4) based on the percentage of patients discharged directly home. We assessed patient and hospital level characteristics and used hierarchical logistic regression to analyze the association of discharge disposition with 30-day readmission. Our cohort included 18 568 transcatheter aortic valve replacement patients at 329 US hospitals, of whom 69% were discharged directly home. Hospitals in the highest quartile of direct home discharge (Q4) compared with hospitals in the lowest (Q1) were more likely to use femoral access (75.2% versus 60.1%, P<0.001), had fewer patients receiving transfusion (26.4% versus 40.9%, P<0.001), and were more likely to be located in the Southern United States (48.8% versus 18.3%, P<0.001). Median 30-day readmission rate was 17.9%. There was no significant difference in 30-day readmissions among quartiles (P=0.14), even after multivariable adjustment (odds ratio Q4 versus Q1=0.89, 95%CI 0.76-1.04; P=0.15). Factors most strongly associated with 30-day readmission were glomerular filtration rate, in-hospital stroke or transient ischemic attack, and nonfemoral access. There was no statistically significant association between hospital practice of direct home discharge post-transcatheter aortic valve replacement and 30-day readmission. Further research is needed to understand regional variations and optimum strategies for postdischarge care. © 2017 The Authors

  4. Preoperative Risk Levels and Vascular Access in Transcatheter Aortic Valve Implantation-A Single-Institute Analysis.

    PubMed

    Kawaguchi, Akira T; Collet, Jean Philippe; Cluzel, Philippe; Makri, Ralouka; Laali, Mojgan; DeFrance, Catherine; Furuya, Hiroyuki; Murakami, Akira; Leprince, Pascal

    2017-02-01

    Although transcatheter aortic valve implantation (TAVI) has been indicated for patients with high surgical risk, indications for or against the procedure become more difficult as vascular access becomes more proximal and/or invasive in order to accommodate patients with even higher risks. We compared preoperative factors including the European System for Cardiac Operative Risk Evaluation (EuroSCORE) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score with postoperative survival in 195 patients undergoing TAVI during 2.5 years (January 2010 to June 2012), when vascular access routes were developed from iliofemoral (IL/Fm access, n = 149), axillo-clavicular, apical, and direct aortic approaches (alternative access, n = 46). Logistic regression analyses showed that alternative access was associated with reduced 30-day survival (P = 0.024), while high surgical risk (>15% in both EuroSCORE and STS score) was associated with reduced 1-year survival (P = 0.046). Thus, patients treated via IL/Fm access had acceptable outcome regardless of preoperative risk levels while patients with low surgical risk (<15%) had favorable outcome irrespective of access route. Since the remaining patients with combined risk factors, high preoperative risk level (>15%) requiring alternative access, had a prohibitive risk in our experience, they might have been considered untreatable or not amenable even to TAVI and offered medical or alternative managements.

  5. Prevalence and Impact of Critical Limb Ischemia on In-Hospital Outcome in Transcatheter Aortic Valve Implantation in Germany.

    PubMed

    Malyar, Nasser M; Kaier, Klaus; Freisinger, Eva; Lüders, Florian; Kaleschke, Gerrit; Baumgartner, Helmut; Frankenstein, Lutz; Reinecke, Holger; Reinöhl, Jochen

    2017-09-05

    Peripheral artery disease (PAD) is common in patients with aortic valve stenosis (AS). We assessed the prevalence of critical limb ischemia (CLI) and its impact on in-hospital outcome in patients undergoing transcatheter aortic valve implantation (TAVI) for severe AS. All isolated TAVI in Germany between 2007 and 2013 for AS were analysed regarding stage specific prevalence of PAD, comorbidities, in-hospital complications and mortality using diagnostic and procedural codes. Among 32,044 patients with TAVI, 3,375 (10.5%) had PAD and 654 (2.0%) CLI. TAVI patients with PAD, particularly those with CLI, had higher incidence of periprocedural stroke, bleeding and acute kidney injury (P<0.001). The overall in-hospital mortality among TAVI without PAD, non-CLI PAD and CLI was 6.1%, 8.4% and 14.7%, respectively (P<0.001). In a multivariate logistic regression analysis CLI was an independent predictor of in-hospital mortality (odds ratio 1.96; 95% confidence interval 1.56-2.47; P<0.001). In patients undergoing TAVI, presence of PAD is associated with an increased risk of periprocedural complications, while only CLI predicts independently increased in-hospital mortality. Whether CLI represents a marker of general poor health status resulting in the poor outcome or a modifiable risk factor whose treatment prior to TAVI can improve the outcome requires prospective studies.

  6. Severe aortic stenosis and coronary artery disease--implications for management in the transcatheter aortic valve replacement era: a comprehensive review.

    PubMed

    Goel, Sachin S; Ige, Mobolaji; Tuzcu, E Murat; Ellis, Stephen G; Stewart, William J; Svensson, Lars G; Lytle, Bruce W; Kapadia, Samir R

    2013-07-02

    Management of coronary artery disease (CAD) in patients with severe aortic stenosis (AS) referred for transcatheter aortic valve replacement (TAVR) is posing challenges. Due to limited and heterogeneous data on the prevalence and clinical impact of CAD on the outcomes of TAVR and the management strategies for CAD in patients undergoing TAVR, we performed a comprehensive review of the literature. Significant CAD is present in 40% to 75% of patients undergoing TAVR. The impact of CAD on outcomes after TAVR remains understudied. Based on existing data, not all patients require revascularization before TAVR. Percutaneous coronary intervention (PCI) should be considered for severely stenotic lesions in proximal coronaries that subtend a large area of myocardium at risk. Ongoing studies randomizing patients to surgical or percutaneous management strategies for severe AS will help provide valuable data regarding the impact of CAD on TAVR outcomes, the role of PCI, and its timing in relation to TAVR. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  7. 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

  8. Comparison of the Edwards SAPIEN S3 Versus Medtronic Evolut-R Devices for Transcatheter Aortic Valve Implantation.

    PubMed

    Ben-Shoshan, Jeremy; Konigstein, Maayan; Zahler, David; Margolis, Gilad; Chorin, Ehud; Steinvil, Arie; Arbel, Yaron; Aviram, Galit; Granot, Yoav; Barkagan, Michael; Keren, Gad; Halkin, Amir; Banai, Shmuel; Finkelstein, Ariel

    2017-01-15

    New generation of the most widely used devices for transcatheter aortic valve implantation have been recently introduced into practice. We compare the short-term outcomes of transcatheter aortic valve implantation with the Edwards SAPIEN S3 and the Medtronic Evolut-R. We performed a retrospective analysis from a single high-volume tertiary center. Valve Academic Research Consortium-2 criteria were used to define composite end points of device success and safety at 30 days. Study population included 232 patients implanted with the SAPIEN S3 (n = 124) and Evolut-R (n = 108). Device success reached 91.9% and 95.4% in the SAPIEN S3 and Evolut-R groups, respectively (p = 0.289). Postprocedural echocardiography showed greater aortic valve gradients (22.8 ± 7 vs 16 ± 9 mm Hg, p <0.001) among SAPIEN S3 group. Paravalvular leak of ≥ moderate severity was observed in 2.4% and 0% in the SAPIEN S3 and Evolut-R groups, respectively (p = 0.251). Similar rates of in-hospital complications, including major bleedings, vascular complications, and pacemaker implantations were recorded in both groups. At 30-day follow-up, the combined safety end point was reached in 5.6% and in 6.5% of patients in the SAPIEN S3 and Evolut-R groups, respectively (p = 0.790). During follow-up of 237 ± 138 days, all-cause mortality was higher in patients implanted with Evolut-R compared with SAPIEN S3 (7 vs 1 cases, respectively, p = 0.006), however, cardiovascular mortality was not significantly different between groups. In conclusions, in a single-center comparative analysis, comparable rate of device success as well as safety profile and long-term cardiovascular mortality were observed with the SAPIEN S3 and Evolut-R valves. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

    PubMed

    Kappetein, A Pieter; Head, Stuart J; Généreux, Philippe; Piazza, Nicolo; van Mieghem, Nicolas M; Blackstone, Eugene H; Brott, Thomas G; Cohen, David J; Cutlip, Donald E; van Es, Gerrit-Anne; Hahn, Rebecca T; Kirtane, Ajay J; Krucoff, Mitchell W; Kodali, Susheel; Mack, Michael J; Mehran, Roxana; Rodés-Cabau, Josep; Vranckx, Pascal; Webb, John G; Windecker, Stephan; Serruys, Patrick W; Leon, Martin B

    2013-01-01

    The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. Two in-person meetings (held in September 2011 in Washington, DC, and in February 2012 in Rotterdam, The Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and noninterventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for

  10. Incidence, predictors, origin and prevention of early and late neurological events after transcatheter aortic valve implantation (TAVI): a comprehensive review of current data.

    PubMed

    Kahlert, Philipp; Al-Rashid, Fadi; Plicht, Björn; Hildebrandt, Heike; Patsalis, Polykarpos; Chilali, Karim El; Wendt, Daniel; Thielmann, Matthias; Bergmann, Lars; Kottenberg, Eva; Schlamann, Marc; Eggebrecht, Holger; Jakob, Heinz; Heusch, Gerd; Konorza, Thomas; Erbel, Raimund

    2013-05-01

    Transcatheter aortic valve implantation (TAVI) is a novel treatment option for patients with severe, symptomatic aortic valve stenosis considered inoperable or at high risk for surgical aortic valve replacement. Despite rapid adoption of this technology into clinical application, however, recent randomized controlled clinical trials have raised safety concerns regarding an increased risk of neurological events with TAVI compared to both medical treatment and conventional, surgical aortic valve replacement. Moreover, neuro-imaging studies have revealed an even higher incidence of new, albeit clinically silent cerebral lesions as a surrogate for procedural embolization. In this article, we review currently available data on the incidence, timing, predictors, prognostic implications and potential mechanisms of neurological events after TAVI.

  11. The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Degenerative aortic valve (AV) stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR) has until recently been the standard of treatment for patients with severe AV stenosis. Whether transcatheter aortic valve implantation (TAVI) can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting. Methods/Design This randomised clinical trial will evaluate the benefits and risks of TAVI using the transarterial CoreValve System (Medtronic Inc., Minneapolis, MN, USA) (intervention group) compared with SAVR (control group) in patients with severe degenerative AV stenosis. Randomisation ratio is 1:1, enrolling a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. Trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention (expected rates 5% for TAVI, 15% for SAVR). Exploratory safety outcomes include procedure complications, valve re-intervention, and cardiovascular death, as well as cardiac, cerebral, pulmonary, renal, and vascular complications. Exploratory efficacy outcomes include New York Heart Association functional status, quality of life, and valve prosthesis and cardiac performance. Enrolment began in December 2009, and 269 patients have been enrolled up to December 2012. Discussion The trial is designed to evaluate the performance of TAVI in comparison with SAVR. The trial results may influence the choice of treatment modality for patients with severe degenerative AV stenosis. Trial registration ClinicalTrials.gov: NCT01057173 PMID:23302232

  12. 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.

  13. A "double crossover technique" in an obese patient undergoing transfemoral transcatheter aortic valve implantation: How to accomplish hemostasis percutaneously?

    PubMed

    Onishi, Hirokazu; Naganuma, Toru; Nakamura, Sunao

    2017-09-01

    Percutaneous transfemoral transcatheter aortic valve implantation (TF-TAVI) is generally an acceptable procedure but may be associated with vascular complications at femoral access sites, particularly in obese patients. This report aimed to describe a case of successful performance of our "double crossover technique" in an obese patient undergoing TF-TAVI with a percutaneous transfemoral intra-aortic balloon pump (TF-IABP). A 75-year-old man presented with heart failure due to a left ventricular ejection fraction of 35% and low-flow, low-gradient severe aortic stenosis. The logistic EuroSCORE and STS-PROM score were 31.38% and 7.311%, respectively. Right TF-TAVI using a 14-Fr expandable sheath and a left TF-IABP using an 8-Fr sheath were scheduled. The patient was obese, with a body mass index of 31.7kg/m(2), and we expected access site-related vascular complications to occur. Subsequently, we performed a femoral and brachial crossover technique, called the "double crossover technique," at the completion of the TAVI procedure: first, for the right common femoral artery (CFA) through the sheath in the left CFA and second, for the left CFA through the sheath in the right brachial artery. In the crossover technique, an 8.0-mm-diameter over-the-wire balloon was advanced to an external iliac artery and was subsequently inflated when the sheath was removed. For the right CFA, a double preclose technique was used with the crossover technique. There was no evidence of access site-related vascular complications following TAVI. The double crossover technique was effective at achieving hemostasis and avoiding access site-related vascular complications in an obese patient undergoing TF-TAVI with a TF-IABP. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    PubMed Central

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

    2017-01-01

    Introduction 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. Aim To assess the dynamics of TAVI adoption in Poland and to detect differences among Polish centres in TAVI practice and decision-making. Material and methods 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). Results 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. Conclusions 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. PMID:28344612

  15. Thirty-day Outcome Following CoreValve Evolut R Transcatheter Aortic Valve Implantation: An All-comers Prospective Study.

    PubMed

    Perrin, Nils; Roffi, Marco; Frei, Angela; Hachulla, Anne-Lise; Ellenberger, Christoph; Müller, Hajo; Cikirikcioglu, Mustafa; Licker, Marc; Noble, Stephane

    2017-09-01

    There are scarce clinical outcomes data on the new generation recapturable and repositionable CoreValve Evolut R. Data on all-comer patients undergoing transcatheter aortic valve implantation (TAVI) with the Evolut R for severe symptomatic aortic stenosis at a single center were prospectively collected between February 2015 and April 2016. Clinical endpoints were independently adjudicated according to the Valve Academic Research Consortium-2 criteria. Primary outcomes consisted of early safety composite endpoints and 30-day device success. The incidence of new permanent pacemaker implantation was recorded. Among the 83 patients undergoing TAVI during this period, 71 (85.5% of the population; median age, 83.0 [interquartile range, 80.0-87.0] years; Society of Thoracic Surgeons scores, 4.8±3.5%) were suitable for Evolut R implantation and were included in the analysis. Repositioning was performed in 26.8% of the procedures. The early safety composite endpoint was observed in 11.3% of patients at 30 days, with 2.8% all-cause mortality. Device success was documented in 90.1% of patients. Paravalvular leakage was less than grade II in 98.4% of patients. The mean transvalvular aortic gradient was reduced from 42.5±14.5mmHg at baseline to 7.7±4.0mmHg at discharge (P<.0001 vs baseline). New permanent pacemaker implantation was required in 23.9% of patients. The new generation Evolut R is suitable for most patients and shows high device success and acceptable mortality in an unbiased, consecutive, all-comer population at a single center performing TAVI exclusively with Medtronic valves. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  16. Predictive Value of the Mehran Score for Contrast-Induced Nephropathy after Transcatheter Aortic Valve Implantation in Patients with Aortic Stenosis.

    PubMed

    Zungur, Mustafa; Gul, Ilker; Tastan, Ahmet; Damar, Ertan; Tavli, Talat

    2016-08-01

    The Mehran risk score (MS) was adopted to predict the development of contrast-induced nephropathy (CIN) and includes clinical and procedural variables. In this study, we aimed to evaluate the value of MS in the prediction of CIN development after transcatheter aortic valve implantation (TAVI). Ninety-three patients (47 females; mean age, 77.2 ± 7.6 years) who underwent aortic valve replacement with TAVI for severe aortic stenosis in our center between June 2013 and November 2014 were included in the study. Patients were categorized into four risk groups based on MS: low (≤5), moderate (6-10), high (11-15), and very high (≥16). CIN was recorded in 24 patients after TAVI (25.8%). The amount of contrast medium was significantly higher in the CIN+ group (p = 0.029), and total mortality was higher in the CIN+ group than in the CIN- group (20.1 vs. 2.9%, respectively; p = 0.024). In univariate analysis, diabetes mellitus, coronary artery disease, ejection fraction, baseline creatinine, baseline glomerular filtration rate, contrast medium volume, and MS were found to be significant risk factors for CIN (p < 0.05 for all). The receiver operating characteristic analysis of the significant variables in multivariate regression analysis revealed that the cutoff MS to predict the development of CIN was 13.0 (area under the curve, 0.654; 95% confidence interval, 0.495-0.758; sensitivity, 62%; specificity, 68%). MS is a predictor of CIN development after TAVI. We think that the use of MS in clinical practice may decrease renal complications after TAVI.

  17. Predictive Value of the Mehran Score for Contrast-Induced Nephropathy after Transcatheter Aortic Valve Implantation in Patients with Aortic Stenosis

    PubMed Central

    Zungur, Mustafa; Gul, Ilker; Tastan, Ahmet; Damar, Ertan; Tavli, Talat

    2016-01-01

    Background/Aims The Mehran risk score (MS) was adopted to predict the development of contrast-induced nephropathy (CIN) and includes clinical and procedural variables. In this study, we aimed to evaluate the value of MS in the prediction of CIN development after transcatheter aortic valve implantation (TAVI). Methods Ninety-three patients (47 females; mean age, 77.2 ± 7.6 years) who underwent aortic valve replacement with TAVI for severe aortic stenosis in our center between June 2013 and November 2014 were included in the study. Patients were categorized into four risk groups based on MS: low (≤5), moderate (6-10), high (11-15), and very high (≥16). Results CIN was recorded in 24 patients after TAVI (25.8%). The amount of contrast medium was significantly higher in the CIN+ group (p = 0.029), and total mortality was higher in the CIN+ group than in the CIN- group (20.1 vs. 2.9%, respectively; p = 0.024). In univariate analysis, diabetes mellitus, coronary artery disease, ejection fraction, baseline creatinine, baseline glomerular filtration rate, contrast medium volume, and MS were found to be significant risk factors for CIN (p < 0.05 for all). The receiver operating characteristic analysis of the significant variables in multivariate regression analysis revealed that the cutoff MS to predict the development of CIN was 13.0 (area under the curve, 0.654; 95% confidence interval, 0.495-0.758; sensitivity, 62%; specificity, 68%). Conclusion MS is a predictor of CIN development after TAVI. We think that the use of MS in clinical practice may decrease renal complications after TAVI. PMID:27648009

  18. Health Status after Transcatheter or Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis at Increased Surgical Risk. Results from the CoreValve US Pivotal Trial

    PubMed Central

    Arnold, Suzanne V.; Reynolds, Matthew R.; Wang, Kaijun; Magnuson, Elizabeth A.; Baron, Suzanne J.; Chinnakondepalli, Khaja M.; Reardon, Michael J.; Tadros, Peter N.; Zorn, George L.; Maini, Brij; Mumtaz, Mubashir A.; Brown, John M.; Kipperman, Robert M.; Adams, David H.; Popma, Jeffrey J.; Cohen, David J.

    2015-01-01

    Background In patients at increased surgical risk, TAVR with a self-expanding bioprosthesis is associated with improved 1-year survival compared with AVR. However, elderly patients may be just as concerned with quality of life improvement as with prolonged survival as a goal of treatment. Objectives To compare the health status outcomes for patients treated with either self-expanding transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (AVR). Methods Between 2011 and 2012, 795 patients with severe aortic stenosis at increased surgical risk were randomized to TAVR or AVR in the CoreValve US Pivotal Trial. Health status was assessed at baseline, 1 month, 6 months, and 1 year using the Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-12, and EQ-5D; growth curve models were used to examine changes over time. Results Over the 1-year follow-up period, disease-specific and generic health status improved substantially for both treatment groups. At 1-month, there was a significant interaction between the benefit of TAVR over AVR and access site. Among surviving patients eligible for iliofemoral (IF) access, there was a clinically relevant early benefit with TAVR across all disease-specific and generic health status measures. Among the non-IF cohort; however, most health status measures were similar for TAVR and AVR, although there was a trend toward early benefit with TAVR on the SF-12 physical health scale. There were no consistent differences in health status between TAVR and AVR at the later time points. Conclusions Health status improved substantially in surviving patients with increased surgical risk who were treated with either self-expanding TAVR or AVR. TAVR via the IF route was associated with better early health status compared with AVR, but there was no early health status benefit with non-IF TAVR compared with AVR. PMID:26292584

  19. Comparison of periprocedural and mid-term stroke rates and outcomes between surgical aortic valve replacement and transcatheter aortic valve replacement patients.

    PubMed

    Aalaei-Andabili, Seyed Hossein; Anderson, R David; Petersen, John W; Beaver, Thomas M; Bavry, Anthony A; Klodell, Charles T

    2017-08-01

    We compared stroke occurrence and outcomes between Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR), both periprocedural and at follow-up. From March 2012 to December 2014, 391 consecutive patients underwent TAVR (N.=290) or isolated SAVR (N.=101), concomitantly. Patients' data were prospectively collected. TAVR patients had more comorbidities. One (0.34%) TIA and 9 (3.11%) strokes occurred in-hospital following TAVR, but no cerebrovascular event occurred after SAVR (P=0.11). One stroke (0.99%) and one TIA (0.99%) were detected in SAVR group within 30 days. Among TAVR patients, one (0.75%) stroke at 6 months, 2 (1.9%) strokes and 2 (1.9%) TIAs at 12 months were diagnosed. Kaplan-Meier analysis revealed that 96% and 99% 12-month CVA free survival following TAVR and SAVR, respectively (P=0.67). Preoperative mean trans-aortic valve systolic pressure gradient higher than 40 mmHg remained as risk factor for stroke in TAVR patients only, OR: 4.48 (CI: 1.2-16.54, P=0.02). One intraoperative death, and 5 (4 with CVA) in-hospital deaths occurred after TAVR; whereas only one patient died in SAVR group (P=0.49). Thirty-day mortality was 3.8% (11/290) for TAVR and 0.99% (1/101) for SAVR patients. SAVR patients' survival was 99% at 6 months, 97.9% at 12, and 96.4% at 24 months, whereas survival in TAVR was 97.5% at 6, 92% at 12, and 73.6% at 24 months (HR: 8.43 (CI: 2.47-28.73), P<0.001). Even with significant differences in patients' baseline characteristics; in-hospital and mid-term stroke rates are not significantly higher following TAVR than SAVR. Although periprocedural stroke is not uncommon in TAVR, mid-term stroke rate is low.

  20. Prognostic value of liver dysfunction assessed by MELD-XI scoring system in patients undergoing transcatheter aortic valve implantation.

    PubMed

    Arai, Takahide; Yashima, Fumiaki; Yanagisawa, Ryo; Tanaka, Makoto; Shimizu, Hideyuki; Fukuda, Keiichi; Watanabe, Yusuke; Naganuma, Toru; Araki, Motoharu; Tada, Norio; Yamanaka, Futoshi; Shirai, Shinichi; Yamamoto, Masanori; Hayashida, Kentaro

    2017-02-01

    There are limited data regarding the influence of liver dysfunction on outcomes of transcatheter aortic valve implantation (TAVI). Model for End-stage Liver Disease eXcluding International normalized ratio (MELD-XI) score, which was originally developed for patients with cirrhosis awaiting liver transplantation, has been reported as a predictor of heart disease. The aim of this study was to investigate the prognostic value of MELD-XI score for patients undergoing TAVI. Data from the prospectively maintained Optimized transCathEter vAlvular iNtervention (OCEAN-TAVI) multicenter registry were collected in 749 patients who underwent TAVI between October 2013 and August 2015. MELD-XI score was calculated as follows: 11.76×Ln (creatinine)+5.11×Ln (total bilirubin)+9.44. Patients were categorized based on MELD-XI score>10 or ≤10, and compared with regard to clinical characteristics and outcomes of TAVI. Higher MELD-XI score was associated with lower 30-day survival (95.6% vs 98.5%, P=0.03). Kaplan-Meier analysis revealed that higher MELD-XI score also was associated with lower 6-month survival (P<0.01). Multivariate Cox regression analysis showed that MELD-XI score was an independent predictor of 6-month cumulative mortality. Receiver operating characteristic analysis revealed that MELD-XI score showed better accuracy in predicting 6-month mortality compared with Logistic European System for Cardiac Operative Risk Evaluation, European System for Cardiac Operative Risk Evaluation II, and Society of Thoracic Surgeons scores (area under the curve=0.67, 0.58, 0.57, and 0.60, respectively). Evaluation of liver dysfunction according to MELD-XI score provides additional risk information for patients undergoing TAVI. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  1. Pre-procedural dual antiplatelet therapy in patients undergoing transcatheter aortic valve implantation increases risk of bleeding.

    PubMed

    Hioki, Hirofumi; Watanabe, Yusuke; Kozuma, Ken; Nara, Yugo; Kawashima, Hideyuki; Kataoka, Akihisa; Yamamoto, Masanori; Takagi, Kensuke; Araki, Motoharu; Tada, Norio; Shirai, Shinichi; Yamanaka, Futoshi; Hayashida, Kentaro

    2017-03-01

    To evaluate the clinical benefit of pre-procedural antiplatelet therapy in patients undergoing transfemoral (TF) transcatheter aortic valve implantation (TAVI). OCEAN (Optimized transCathEter vAlvular interveNtion)-TAVI is a prospective, multicentre, observational cohort registry, enrolling 749 patients who underwent TAVI from October 2013 to August 2015 in Japan. We identified 540 patients (median age 85 years, 68.1% female) undergoing TF-TAVI; of these, 80 had no pre-procedural antiplatelet therapy and 460 had antiplatelet therapy. The endpoints were any bleeding (life-threatening, major, and minor bleeding) and thrombotic events (stroke, myocardial infarction, and valve thrombosis) during hospitalisation. Patients with dual antiplatelet therapy (DAPT) had a significantly higher incidence of any bleeding than those with single antiplatelet therapy (SAPT) (36.5% vs 27.5%, p=0.049) and no antiplatelet therapy (36.5% vs 21.3%, p=0.010). Patients without pre-procedural antiplatelet therapy did not experience an increased risk of thrombotic events. In multivariable logistic regression analysis, DAPT before TF-TAVI significantly increased any bleeding compared with SAPT (OR 2.05, 95% CI 1.16 to 3.65) and no antiplatelet therapy (OR 2.30, 95% CI 1.08 to 4.90). The current study demonstrated that DAPT before TF-TAVI increased the risk of bleeding compared with single or no antiplatelet therapy. Lower intensity antiplatelet therapy was not associated with thrombotic events. In modern practice, it might be reasonable to perform TAVI using single or no pre-procedural antiplatelet therapy with an expectation of no increase of adverse events. UMIN-ID; 000020423; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  2. 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

  3. 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

  4. Health Status After Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Increased Surgical Risk: Results From the CoreValve US Pivotal Trial.

    PubMed

    Arnold, Suzanne V; Reynolds, Matthew R; Wang, Kaijun; Magnuson, Elizabeth A; Baron, Suzanne J; Chinnakondepalli, Khaja M; Reardon, Michael J; Tadros, Peter N; Zorn, George L; Maini, Brij; Mumtaz, Mubashir A; Brown, John M; Kipperman, Robert M; Adams, David H; Popma, Jeffrey J; Cohen, David J

    2015-08-17

    This study sought to compare the health status outcomes for patients treated with either self-expanding transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (AVR). In patients at increased surgical risk, TAVR with a self-expanding bioprosthesis is associated with improved 1-year survival compared with AVR. However, elderly patients may be just as concerned with quality-of-life improvement as with prolonged survival as a goal of treatment. Between 2011 and 2012, 795 patients with severe aortic stenosis at increased surgical risk were randomized to TAVR or AVR in the CoreValve US Pivotal Trial. Health status was assessed at baseline, 1 month, 6 months, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short-Form 12 Questionnaire, and EuroQOL 5-dimension questionnaire; growth curve models were used to examine changes over time. Over the 1-year follow-up period, disease-specific and generic health status improved substantially for both treatment groups. At 1 month, there was a significant interaction between the benefit of TAVR over AVR and access site. Among surviving patients eligible for iliofemoral (IF) access, there was a clinically relevant early benefit with TAVR across all disease-specific and generic health status measures. Among the non-IF cohort, however, most health status measures were similar for TAVR and AVR, although there was a trend toward early benefit with TAVR on the Short-Form 12 Questionnaire's physical health scale. There were no consistent differences in health status between TAVR and AVR at the later time points. Health status improved substantially in surviving patients with increased surgical risk who were treated with either self-expanding TAVR or AVR. TAVR via the IF route was associated with better early health status compared with AVR, but there was no early health status benefit with non-IF TAVR compared with AVR. (Safety and Efficacy Study of the Medtronic Core

  5. Quality of life among elderly patients undergoing transcatheter or surgical aortic valve replacement- a model-based longitudinal data analysis.

    PubMed

    Kaier, Klaus; Gutmann, Anja; Baumbach, Hardy; von Zur Mühlen, Constantin; Hehn, Philip; Vach, Werner; Beyersdorf, Friedhelm; Zehender, Manfred; Bode, Christoph; Reinöhl, Jochen

    2016-07-26

    Quality of life (QoL) measurements reported in observational studies are often biased, since patients who failed to improve are more likely to be unable to respond due to death or impairment. In order to observe the development of QoL in patients close to death, we analyzed a set of monthly QoL measurements for a cohort of elderly patients treated for aortic valve stenosis (AS) with special consideration of the effect of distance to death. QoL in 169 elderly patients (age ≥ 75 years), treated either with transcatheter aortic valve replacement (TAVR; n = 92), surgical aortic-valve replacement (n = 70), or drug-based therapy (n = 7), was evaluated using the standardized EQ-5D questionnaire. Over a two-year period, patients were consulted using monthly telephone interviews or outpatient visits, leading to a total of 2463 time points at which QoL values, New York Heart Association (NYHA) Functional Classification and their status of assistance were assessed. Furthermore, post-procedural clinical events and complications were monitored. Linear and ordered logistic regression analyses with random intercept were carried out, taking into account overall trends and distance to death. QoL measures decreased slightly over time, were temporarily impaired at month 1 after the initial episode of hospitalization and decreased substantially at the end of life with a measurable effect starting at the sixth from last follow-up (month) before death. Many clinical complications (bleeding complications, stroke, acute kidney injury) showed an impairment of QoL measurements, but the inclusion of lagged variables demonstrated medium term (three months) QoL impairments for access site bleeding only. All other complications are associated with event-related impairments that decreased dramatically at the second and third follow-up interviews (month) after event. Distance to death shows clear effects on QoL and should be taken into account when analyzing QoL measures in the

  6. The impact of transcatheter aortic valve implantation on left ventricular performance and wall thickness – single-centre experience

    PubMed Central

    Szymański, Piotr; Dąbrowski, Maciej; Zakrzewski, Dariusz; Michałek, Piotr; Orłowska-Baranowska, Ewa; El-Hassan, Kamal; Chmielak, Zbigniew; Witkowski, Adam; Hryniewiecki, Tomasz

    2015-01-01

    Introduction Transcatheter aortic valve implantation (TAVI) is a treatment alternative for the elderly population with severe symptomatic aortic stenosis (AS) at high risk for surgical aortic valve replacement (SAVR). Aim To assess the impact of TAVI on echocardiographic parameters of left ventricular (LV) performance and wall thickness in patients subjected to the procedure in a single-centre between 2009 and 2013. Material and methods The initial group consisted of 170 consecutive patients with severe AS unsuitable for SAVR. Logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) was 21.73 ±12.42% and mean age was 79.9 ±7.5 years. Results The TAVI was performed in 167 (98.2%) patients. Mean aortic gradient decreased significantly more rapidly after the procedure (from 58.6 ±16.7 mm Hg to 11.9 ±4.9 mm Hg, p < 0.001). The LV ejection fraction (LVEF) significantly increased in both short-term and long-term follow-up (57 ±14% vs. 59 ±13%, p < 0.001 and 56 ±14% vs. 60 ±12%, p < 0.001, respectively). Significant regression of interventricular septum diameter at end-diastole (IVSDD) and end-diastolic posterior wall thickness (EDPWth) was noted in early (15.0 ±2.4 mm vs. 14.5 ±2.3 mm, p < 0.001 and 12.7 ±2.1 mm vs. 12.4 ±1.9 mm, p < 0.028, respectively) and late post-TAVI period (15.1 ±2.5 mm to 14.3 ±2.5 mm, p < 0.001 and 12.8 ±2.0 mm to 12.4 ±1.9 mm, p < 0.007, respectively). Significant paravalvular leak (PL) was noted in 21 (13.1%) patients immediately after TAVI and in 13 (9.6%) patients in follow-up (p < 0.001). Moderate or severe mitral regurgitation (msMR) was seen in 24 (14.9%) patients from the initial group and in 19 (11.8%) patients after TAVI (p < 0.001). Conclusions The TAVI had an immediate beneficial effect on LVEF, LV walls thickness, and the incidence of msMR. The results of the procedure are comparable with those described in other centres. PMID:25848369

  7. Transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low and intermediate risk: systematic review and meta-analysis

    PubMed Central

    Agoritsas, Thomas; Manja, Veena; Devji, Tahira; Chang, Yaping; Bala, Malgorzata M; Thabane, Lehana; Guyatt, Gordon H

    2016-01-01

    Objective To examine the effect of transcatheter aortic valve implantation (TAVI) versus surgical replacement of an aortic valve (SAVR) in patients with severe aortic stenosis at low and intermediate risk of perioperative death. Design Systematic review and meta-analysis Data sources Medline, Embase, and Cochrane CENTRAL. Study selection Randomized trials of TAVI compared with SAVR in patients with a mean perioperative risk of death <8%. Review methods Two reviewers independently extracted data and assessed risk of bias for outcomes important to patients that were selected a priori by a parallel guideline committee, including patient advisors. We used the GRADE system was used to quantify absolute effects and quality of evidence. Results 4 trials with 3179 patients and a median follow-up of two years were included. Compared with SAVR, transfemoral TAVI was associated with reduced mortality (risk difference per 1000 patients: −30, 95% confidence interval −49 to −8, moderate certainty), stroke (−20, −37 to 1, moderate certainty), life threatening bleeding (−252, −293 to −190, high certainty), atrial fibrillation (−178, −150 to −203, moderate certainty), and acute kidney injury (−53, −39 to −62, high certainty) but increased short term aortic valve reintervention (7, 1 to 21, moderate certainty), permanent pacemaker insertion (134, 16 to 382, moderate certainty), and moderate or severe symptoms of heart failure (18, 5 to 34, moderate certainty). Compared with SAVR, transapical TAVI was associated higher mortality (57, −16 to 153, moderate certainty, P=0.015 for interaction between transfemoral versus transapical TAVI) and stroke (45, −2 to 125, moderate certainty, interaction P=0.012). No study reported long term follow-up, which is particularly important for structural valve deterioration. Conclusions Many patients, particularly those who have a shorter life expectancy or place a lower value on the risk of long term valve

  8. 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

  9. One-Year Outcomes of Transcatheter Aortic Valve Replacement in Patients With End-Stage Renal Disease.

    PubMed

    O'Hair, Daniel P; Bajwa, Tanvir K; Chetcuti, Stanley J; Deeb, G Michael; Stoler, Robert C; Hebeler, Robert F; Maini, Brijeshwar; Mumtaz, Mubashir; Kleiman, Neal S; Reardon, Michael J; Li, Shuzhen; Adams, David H; Watson, Daniel R; Yakubov, Steven J; Popma, Jeffrey J; Petrossian, George

    2017-05-01

    End-stage renal disease (ESRD) poses unique challenges in the treatment of patients with severe aortic stenosis. Although surgical valve replacement in ESRD patients has been associated with increased mortality, the outcomes from transcatheter aortic valve replacement (TAVR) are not clearly defined. The CoreValve US Expanded Use Study is a prospective, nonrandomized study of TAVR in extreme-risk patients with comorbidities excluding them from the Pivotal Trial. We report on patients with ESRD. The primary endpoint was a composite of all-cause mortality or major stroke at 1 year. Ninety-six patients with ESRD underwent TAVR with the CoreValve (Medtronic, Minneapolis, MN) and have reached 1-year follow-up. Mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 16.2% ± 8.4%. The rate of all-cause mortality or major stroke at 1 year was 30.3%. The all-cause mortality rate was 5.3% at 30 days and 30.3% at 1 year. The rate at 1 year of any stroke or transient ischemic attack was 2.1%; major vascular injury was 5.2%; and new permanent pacemaker was 26.8%. Valve performance improved postprocedure and remained improved at 1 year (effective orifice area 1.71 cm(2), mean gradient 9.33 mm Hg) CONCLUSIONS: Early mortality in patients with ESRD is comparable to previously published data on extreme-risk patients without ESRD, but our data suggest a higher mortality rate at 1 year for ESRD patients, likely due to comorbid conditions. Stroke and major vascular injury are infrequent, and improved valve hemodynamics are maintained at 1 year. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  10. Early and late outcomes after trans-catheter aortic valve implantation in patients with previous chest radiation.

    PubMed

    Bouleti, Claire; Amsallem, Myriam; Touati, Aziza; Himbert, Dominique; Iung, Bernard; Alos, Benjamin; Brochet, Eric; Urena, Marina; Ghodbane, Walid; Ou, Phalla; Dilly, Marie-Pierre; Nataf, Patrick; Vahanian, Alec

    2016-07-01

    Surgery for aortic stenosis in patients with thoracic radiation therapy is associated with high morbi-mortality. Trans-catheter aortic valve implantation (TAVI) represents an alternative but has never been studied in this population. We aimed to compare outcomes in radiation and matched control patients undergoing TAVI and to identify predictive factors of survival. Between 2006 and 2011, 288 consecutive patients underwent TAVI in our institution, of whom 26 had previous chest radiation. They were matched 1:1 for age, sex and TAVI approach with controls. In both groups, median age was 73 years, 50% of patients were male and 15% had a transapical approach. Procedural success was 88% in the radiation group versus 100% in controls (p<0.001) and 30-day survival was 92% in both groups. Five-year survival was 33%±10% in the radiation group and 42%±11% in controls (p=0.26). In radiation patients, the main cause of death was respiratory insufficiency in 40%. We identified four independent predictive factors of death in the radiation group: extracardiac arteriopathy (p=0.002) and the absence of β-blocker therapy (p=0.005) as preprocedural variables, and infectious complications (p=0.009) and a higher peak creatinine level (p=0.009) as postprocedural variables. In the radiation group, 89% of survivors were in New York Heart Association class I-II at last follow-up. Patients in the radiation group displayed high mortality rates although not significantly different from the controls. Respiratory failure was the main cause of death, emphasising the need for a careful pulmonary evaluation. Finally, we show a sustained improvement in functional results after TAVI in this population. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  11. 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

  12. Optimal projection estimation for transcatheter aortic valve implantation based on contrast-aortography: validation of a Prototype Software.

    PubMed

    Tzikas, Apostolos; Schultz, Carl; Van Mieghem, Nicolas M; de Jaegere, Peter P T; Serruys, Patrick W

    2010-10-01

    We investigate the accuracy of a new software system (C-THV, Paieon) designed to calculate the optimal projection (OP) view for transcatheter aortic valve implantation (TAVI) based on two aortograms, and its agreement with the operator's choice. An optimal fluoroscopic working view projection with all three aortic cusps depicted in one line, is crucial during TAVI. In our institution selection of the OP is based on multislice computed tomography (MSCT). Seventy-three consecutive patients referred for TAVI were divided into two groups. For the first group (53 patients, retrospective cohort) we compared the OP views estimated by C-THV with the ones estimated by MSCT. For the second group (20 patients, prospective cohort), we compared the OP views estimated by C-THV with the operator's choice during TAVI. For the retrospective cohort, the mean absolute difference (mean ± SD) between C-THV and MSCT was 6.6 ± 4.9 degrees. In 77% of the cases the mean difference between C-THV and MSCT was <10 degrees. For the prospective cohort, the mean absolute difference (mean ± SD) between C-THV and the operator's choice was 5.5 ± 3.4 degrees. A mean difference of <10 degrees was found in 90% of the cases. In this study we found that the C-THV software estimated the OP view for TAVI with good accuracy. The level of agreement between C-THV and either the MSCT or the operator's choice was deemed satisfactory, with the vast majority of observed differences being <10 degrees. © 2010 Wiley-Liss, Inc.

  13. Comparison of Systematic Predilation, Selective Predilation, and Direct Transcatheter Aortic Valve Implantation With the SAPIEN S3 Valve.

    PubMed

    Spaziano, Marco; Sawaya, Fadi; Chevalier, Bernard; Roy, Andrew; Neylon, Antoinette; Garot, Philippe; Hovasse, Thomas; Benamer, Hakim; Romano, Mauro; Unterseeh, Thierry; Bouvier, Erik; Cormier, Bertrand; Morice, Marie-Claude; Lefèvre, Thierry

    2017-02-01

    Despite previously described feasibility, direct transcatheter aortic valve implantation (TAVI) with the Edwards SAPIEN S3 device (S3-THV) (Edwards Lifesciences, Irvine, CA) has not been compared with either a systematic or a selective predilation approach. Patients undergoing predilation were divided into a systematic group (regardless of anatomic features) and a selective group (in the context of high valvular calcium burden). Both groups were matched in a 2:1 fashion to patients who underwent direct TAVI. Outcomes were assessed according to Valve Academic Research Consortium 2 (VARC-2) criteria. Two hundred eighty-one patients underwent TAVI with the S3-THV in our centre. Of these patients, 58 underwent predilation before device implantation (systematic, n = 26; selective, n = 32). Procedural success was achieved in all patients. Patients in the selective predilation group had severe valve calcification volume-more than double that of the systematic group (445 ± 306 mm(3) vs 970 ± 578 mm(3), respectively; P < 0.0001). There was a trend for less dilation after the procedure in the systematic group compared with the selective group (4% vs 19%, respectively; P = 0.09). Device malposition necessitating a second device to be implanted occurred in 3 cases of direct TAVI (5%) and in none of the patients undergoing predilation (P = not significant). Thirty-day and 1-year mortality rates were similar between the patients who underwent direct TAVI and their predilation counterparts. In patients with a moderate aortic valve calcification burden, direct TAVI appears to be feasible and safe. In those with high calcium burden, predilation should be considered after taking into account individual risk profiles. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  14. Transcatheter aortic valve implantation in obese patients: Overcoming technical challenges and maintaining adequate hemodynamic performance using new generation prostheses.

    PubMed

    Kische, Stephan; D'Ancona, Giuseppe; Agma, Hüseyin U; El-Achkar, Gihan; Dißmann, Martin; Ortak, Jasmin; Öner, Alper; Ketterer, Ulrike; Bärisch, Anne; Levenson, Benny; Ince, Hüseyin

    2016-10-01

    Second-generation TAVI prostheses may enhance the procedure reducing operative time and complications rate, maintaining adequate valve hemodynamic performance. We present our results with 2 new generation trans-catheter aortic valve (TAVI) prostheses in obese patients. A series of 172 patients underwent trans-femoral TAVI with new generation prostheses (Direct Flow Medical, DFM®, and LOTUS®). Two groups were identified according to body mass index (BMI): group NO (125) BMI<30kg/m(2) and group O (47) BMI≥30kg/m(2). Trans-femoral approach was possible in all patients without conversion to conventional surgery/cardiopulmonary bypass. Operative/fluoroscopy time and contrast use were comparable. Vascular and bleeding complications were also equally represented in the 2 groups. Thirty-day mortality was 7.2% in group NO and 6.4% in group O (p=0.9). At discharge, aortic regurgitation was absent/mild in 96% of group NO and in all patients in group O (p=0.3). Mild prosthetic stenosis was reported in 3.8% of the patients in group NO and 2.2% in group O. No moderate/severe prosthetic stenosis was reported. Estimated 1-year survival was 93.1% in group NO and 83.2% in group O (p=0.6). Estimated 1-year freedom from MACCE was 74.7% in group NO and 62.8% in group O (p=0.4). At follow-up echocardiography no significant differences were noticed in the 2 groups. Second generation TAVI prostheses allow for safe and effective procedures in obese patients. In spite of patient's body habitus, agile prosthesis placement will lead to optimized hemodynamics. Valve and clinical performance are confirmed at follow-up. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  15. Neurological Events Following Transcatheter Aortic Valve Replacement and Their Predictors: A Report From the CoreValve Trials.

    PubMed

    Kleiman, Neal S; Maini, Brijeshwar J; Reardon, Michael J; Conte, John; Katz, Stanley; Rajagopal, Vivek; Kauten, James; Hartman, Alan; McKay, Raymond; Hagberg, Robert; Huang, Jian; Popma, Jeffrey

    2016-09-01

    The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. Identification of predictors for stroke is likely to be a critical factor aiding patient selection and management as TAVR use becomes widespread. Patients enrolled in the CoreValve US Extreme Risk and High Risk Pivotal Trials or Continued Access Study treated with the self-expanding CoreValve bioprosthesis were included in this analysis. The 1-year stroke rate after TAVR was 8.4%. Analysis of the stroke hazard rate identified an early phase (0-10 days; 4.1% of strokes) and a late phase (11-365 days; 4.3% of strokes). Baseline predictors of early stroke included National Institutes of Health stroke scale score >0, prior stroke, prior transient ischemic attack, peripheral vascular disease, absence of prior coronary artery bypass surgery, angina, low body mass index (<21 kg/m(2)), and falls within the past 6 months. Significant procedural predictors were total time in the catheterization laboratory or operating room, delivery catheter in the body time, rapid pacing used during valvuloplasty, and repositioning of the prosthesis. Predictors of stroke between 11 and 365 days were small body surface area, severe aortic calcification, and falls within the past 6 months. There were no significant imaging predictors of early or late stroke. Predictors of early stroke after TAVR included clinical and procedural factors; predictors of later stroke were limited to patient but not anatomic characteristics. These findings indicate that further refinement of imaging to identify anatomic factors predisposing to embolization may help improve stroke prediction in patients undergoing TAVR. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01240902, NCT01531374. © 2016 American Heart Association, Inc.

  16. Comparison in Men Versus Women of Co-morbidities, Complications, and Outcomes After Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis.

    PubMed

    Gaglia, Michael A; Lipinski, Michael J; Torguson, Rebecca; Gai, Jiaxiang; Ben-Dor, Itsik; Bernardo, Nelson L; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

    2016-12-01

    Transcatheter aortic valve implantation (TAVI) decreases mortality in high-risk patients with severe aortic stenosis, but it remains unclear if female gender is associated with more favorable outcomes after TAVI. All patients who underwent TAVI at a single institution were retrospectively analyzed and stratified by gender. Procedural, in-hospital, 30-day, and 1-year outcomes were defined according to the second Valve Academic Research Consortium. The primary end point was all-cause mortality at 1 year. Kaplan-Meier survival analysis and multivariable Cox proportional hazards regression were conducted. Overall, 755 patients underwent TAVI and were included in the study; 50.7% were women. Average age was 83.0 ± 7.7 years, with a mean Society of Thoracic Surgeons score of 8.9 ± 4.6. Women were older than men and more likely to be black. Most co-morbidities were less common among women, and they were more likely than men to suffer both in-hospital (8.4% vs 4.3%, p = 0.021) and 30-day (9.4% vs 5.4%, p = 0.035) all-cause mortality. Life-threatening bleeding, transfusion, and iliofemoral dissection or perforation were more common among women. There was no difference in mortality between women and men at 1 year (20.6% vs 21.5%, log-rank p = 0.87). After multivariable adjustment, however, female gender was independently associated with lower mortality at 1 year after TAVI. In conclusion, despite higher rates of major bleeding, vascular complications, and 30-day mortality, female gender was independently associated with improved survival at 1 year after TAVI.

  17. Aortic Regurgitation in Patients Undergoing Transcatheter Aortic Valve Replacement With the Self-Expanding CoreValve Versus the Balloon-Expandable SAPIEN XT Valve.

    PubMed

    Kiramijyan, Sarkis; Magalhaes, Marco A; Koifman, Edward; Didier, Romain; Escarcega, Ricardo O; Baker, Nevin C; Negi, Smita I; Minha, Sa'ar; Torguson, Rebecca; Jiaxiang, Gai; Asch, Federico M; Wang, Zuyue; Okubagzi, Petros; Gaglia, Michael A; Ben-Dor, Itsik; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

    2016-05-01

    The incidence of aortic regurgitation (AR) after transcatheter aortic valve replacement (TAVR) in a self-expanding and a balloon-expandable system is controversial. This study aimed to examine the incidence and severity of post-TAVR AR with the CoreValve (CV) versus the Edwards XT Valve (XT). Baseline, procedural, and postprocedural inhospital outcomes were compared. The primary end point was the incidence of post-TAVR AR of any severity, assessed with a transthoracic echocardiogram, in the CV versus XT groups. A multivariate logistic regression analysis was completed to evaluate for correlates of the primary end point. The secondary end points included the change in severity of AR at 30-day and 1-year follow-up. A total of 223 consecutive patients (53% men, mean age 82 years) who had transfemoral TAVR with either a CV (n = 119) or XT (n = 104) were evaluated. The rates of post-TAVR AR in the groups were similar, and there was no evidence of more-than-moderate AR in either group. There were significant differences in the rates of intraprocedural balloon postdilation with the CV (17.1%) versus XT valve (5.8%; p = 0.009) and in the rates of intraprocedural implantation of a second valve-in-valve prosthesis with the CV (9.9%) versus XT valve (2.2%; p = 0.036). There were no significant differences in inhospital safety outcomes between the 2 groups. In conclusion, the incidence of post-TAVR AR is similar between the CV and the XT valve when performed by experienced operators using optimal intraprocedural strategies, as deemed appropriate, to mitigate the severity of AR.

  18. 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.

  19. 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

    2017-09-18

    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.

  20. Radiation dose of patients undergoing transcatheter aortic valve implantation: a comparison between Edwards SAPIEN XT and Medtronic CoreValve aortic valve prostheses.

    PubMed

    Steinvil, Arie; Aviram, Galit; Konigstein, Maayan; Abramowitz, Yigal; Halkin, Amir; Arbel, Yaron; Ben-Gal, Yanai; Keren, Gad; Banai, Shmuel; Finkelstein, Ariel

    2013-10-01

    The relative radiation dose (RD) of patients undergoing transcatheter aortic valve implantation (TAVI) with either the Edwards Sapien XT (ESX) or the Medtronic CoreValve (MCV) prostheses has not been studied in depth. Our aim was to quantify RD in uncomplicated transfemoral TAVI with either prosthesis. We analyzed 248 consecutive patients undergoing uncomplicated transfemoral TAVI between March 2009 and September 2012, at a single tertiary care facility. Total air Kerma, cumulated dose area product (DAP), and fluoroscopy time were determined in each case. The ESX and MCV prostheses were implanted in 44 and 204 patients, respectively. Though mean fluoroscopy time was higher during ESX valve implantation, overall RD per total air Kerma and DAP was significantly higher during MCV implantation (P < 0.05 for both comparisons). By multivariate regression analyses, prosthesis type was an independent predictor of RD according to both total air Kerma and DAP (r(2) = 0. 498; P < 0.01 and r(2) = 0.363; P < 0.01, respectively). In uncomplicated transfemoral TAVI, RD is greater during MCV implantation than during ESX implantation. Copyright © 2013 Wiley Periodicals, Inc.

  1. 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

  2. Automated and Manual Measurements of the Aortic Annulus with ECG-Gated Cardiac CT Angiography Prior to Transcatheter Aortic Valve Replacement: Comparison with 3D-Transesophageal Echocardiography.

    PubMed

    Guez, David; Boroumand, Gilda; Ruggiero, Nicholas J; Mehrotra, Praveen; Halpern, Ethan Joseph

    2017-05-01

    Multimodality evaluation of the aortic annulus is generally advocated to plan for transcatheter aortic valve replacement (TAVR). We compared aortic annular measurements by cardiac computed tomography angiography (cCTA) to three-dimensional transesophageal echocardiography (3D-TEE), and also evaluated the use of semi-automated software for cCTA annular measurements. A retrospective cohort of 74 patients underwent 3D-TEE and electrocardiogram-gated cCTA of the heart within 30 days for TAVR planning. 3D-TEE measurements were obtained during mid-systole; cCTA measurements were obtained during late-systole (40% of R-R interval) and mid-diastole (80% of R-R interval). Annular area was measured independently by manual planimetry and with semi-automated software. cCTA measurements in systole and diastole were highly correlated for short-axis diameter (r = 0.91), long-axis diameter (r = 0.92), and annular area (r = 0.96), although systolic measurements were significantly larger (P < 0.001), most notably for the short-axis diameter. Good correlation was observed between 3D-TEE and cCTA for short-axis diameter (r = 0.84-0.90), long-axis diameter (r = 0.77-0.79), and annular area (r = 0.89-0.90). As compared to 3D-TEE, annular area is overmeasured by 28 mm(2) on systolic phase cCTA (P < 0.008), but nearly identical with 3D-TEE on diastolic phase cCTA. Semi-automated and manual cCTA annulus measurements were highly correlated in systole (r = 0.94) and diastole (r = 0.93), although the semi-automated annular area measured 11-30 mm(2) greater than manual planimetry. Of note, the 95% limits of agreement in our Bland-Altman analysis suggest that the variability in annular area estimates for individual patients between cCTA and 3D-TEE (-100.9 to 99.6 mm(2)), as well as the variability between manual and automated measurements with cCTA (-105.9 to 45.2 mm(2)), may be sufficient to alter size selection for an aortic prosthesis. Although

  3. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study.

    PubMed

    Osnabrugge, Ruben L J; Mylotte, Darren; Head, Stuart J; Van Mieghem, Nicolas M; Nkomo, Vuyisile T; LeReun, Corinne M; Bogers, Ad J J C; Piazza, Nicolo; Kappetein, A Pieter

    2013-09-10

    The purpose of this study was to evaluate the prevalence of aortic stenosis (AS) in the elderly and to estimate the current and future number of candidates for transcatheter aortic valve replacement (TAVR). Severe AS is a major cause of morbidity and mortality in the elderly. A proportion of these patients is at high or prohibitive risk for surgical aortic valve replacement, and is now considered for TAVR. A systematic search was conducted in multiple databases, and prevalence rates of patients (>75 years) were pooled. A model was based on a second systematic literature search of studies on decision making in AS. Monte Carlo simulations were performed to estimate the number of TAVR candidates in 19 European countries and North America. Data from 7 studies (n = 9,723 subjects) were used. The pooled prevalence of all AS in the elderly was 12.4% (95% confidence interval [CI]: 6.6% to 18.2%), and the prevalence of severe AS was 3.4% (95% CI: 1.1% to 5.7%). Among elderly patients with severe AS, 75.6% (95% CI: 65.8% to 85.4%) were symptomatic, and 40.5% (95% CI: 35.8% to 45.1%) of these patients were not treated surgically. Of those, 40.3% (95% CI: 33.8% to 46.7%) received TAVR. Of the high-risk patients, 5.2% were TAVR candidates. Projections showed that there are approximately 189,836 (95% CI: 80,281 to 347,372) TAVR candidates in the European countries and 102,558 (95% CI: 43,612 to 187,002) in North America. Annually, there are 17,712 (95% CI: 7,590 to 32,691) new TAVR candidates in the European countries and 9,189 (95% CI: 3,898 to 16,682) in North America. With a pooled prevalence of 3.4%, the burden of disease among the elderly due to severe AS is substantial. Under the current indications, approximately 290,000 elderly patients with severe AS are TAVR candidates. Nearly 27,000 patients become eligible for TAVR annually. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  4. Consequence of cerebral embolism after transcatheter aortic valve implantation compared with contemporary surgical aortic valve replacement: effect on health-related quality of life.

    PubMed

    Uddin, Akhlaque; Fairbairn, Timothy A; Djoukhader, Ibrahim K; Igra, Mark; Kidambi, Ananth; Motwani, Manish; Herzog, Bernhard; Ripley, David P; Musa, Tarique Al; Goddard, Anthony J P; Blackman, Daniel J; Plein, Sven; Greenwood, John P

    2015-03-01

    Incidence of cerebral microinfarcts is higher after transcatheter aortic valve implantation (TAVI) compared with surgical aortic valve replacement (SAVR). It is unknown whether these lesions persist and what direct impact they have on health-related quality of life. The objective was to identify predictors of cerebral microinfarction and measure their effect on health-related quality of life during 6 months after TAVI when compared with SAVR. Cerebral MRI was conducted at baseline, post procedure, and 6 months using diffusion-weighted imaging. Health-related quality of life was measured at baseline, 30 days, and 6 months with short form-12 health outcomes and EuroQol 5 dimensions questionnaires. One hundred eleven patients (TAVI, n=71; SAVR, n=40) were studied. The incidence (54 [77%] versus 17 [43%]; P=0.001) and number (3.4±4.9 versus 1.2±1.8; P=0.001) of new microinfarcts were greater after TAVI than after SAVR. The total volume per microinfarct was smaller in TAVI than in SAVR (0.23±0.24 versus 0.76±1.8 mL; P=0.04). The strongest associations for microinfarction were: TAVI (arch atheroma grade: r=0.46; P=0.0001) and SAVR (concomitant coronary artery bypass grafting: r=-0.33; P=0.03). Physical component score in TAVI increased after 30 days (32.1±6.6 versus 38.9±7.0; P<0.0001) and 6 months (40.4±9.3; P<0.0001); the improvement occurred later in SAVR (baseline: 34.9±10.6; 30 days: 35.9±10.2; 6 months: 42.8±11.2; P<0.001). After TAVI, there were no differences in the short form-12 health outcome scores according to the presence or size of new cerebral infarction. Cerebral microinfarctions are more common after TAVI compared with SAVR but seem to have no negative effect on early (30 days) or medium term (6 months) health-related quality of life. Aortic atheroma (TAVI) and concomitant coronary artery bypass grafting (SAVR) are independent risk factors for cerebral microinfarction. © 2015 American Heart Association, Inc.

  5. [Conduction disturbances and permanent cardiac pacing after transcatheter implantation of the CoreValve aortic bioprosthesis: initial single centre experience].

    PubMed

    Czerwińska, Katarzyna; Hryniewiecki, Tomasz; Oręziak, Artur; Dąbrowski, Maciej; Michałowska, Ilona; Witkowski, Adam; Demkow, Marcin; Stępińska, Janina; Orłowska Baranowska, Ewa; Rużyłło, Witold

    2012-01-01

    The rate of significant conduction disturbances requiring permanent pacemaker implantation (PPI) following surgical aortic valve replacement (AVR) is 2-8%. Transcatheter aortic valve implantation (TAVI) is an alternative management approach in patients with severe aortic stenosis who are not considered candidates for AVR. The TAVI using the CoreValve (CV) bioprosthesis is associated with a nearly 30% rate of conduction disturbances requiring postprocedural PPI. To provide an initial evaluation of the rate of conduction disturbances and the need for PPI, and to analyse factors that increase the risk of this complication in patients undergoing TAVI using CV bioprosthesis. In addition, we evaluated the rate of permanent conduction disturbances in patients who underwent PPI at one year after TAVI. We studies 22 initial patients in a single centre who underwent CV bioprosthesis implantation in 2009-2010. After exclusion of 6 patients with preprocedural PPI, we ultimately evaluated 16 patients. Uni- and multivariate analyses were performed using χ(2), Fisher, and Wilcoxon tests, and logistic regression analysis was performed using the SAS software. Overall, 8 (50%) patients in our study group required PPI after TAVI (TAVI + PPI), and the remaining 8 patients did not require PPI (TAVI). The most common indication for PPI was complete heart block. The decision to implant a pacemaker was made on average at 9 ± 7 days following TAVI (range 3 to 22 days). When we analysed risk factors for PPI that were unrelated to the TAVI procedure, we found that the TAVI + PPI group was characterised (vs the TAVI group) by a significantly larger diameter of the native aortic valve (p = 0.03) and a larger left ventricular outflow tract (LVOT) dimension in the frontal (p = 0.02) and the corresponding frontal dimension in the transverse view (p = 0.01) by computed tomography angiography. Logistic regression analysis showed that the risk of PPI increased more than 2.5 times for each increase

  6. Determinants and outcomes of acute transcatheter valve-in-valve therapy or embolization: a study of multiple valve implants in the U.S. PARTNER trial (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve).

    PubMed

    Makkar, Raj R; Jilaihawi, Hasan; Chakravarty, Tarun; Fontana, Gregory P; Kapadia, Samir; Babaliaros, Vasilis; Cheng, Wen; Thourani, Vinod H; Bavaria, Joseph; Svensson, Lars; Kodali, Susheel; Shiota, Takahiro; Siegel, Robert; Tuzcu, E Murat; Xu, Ke; Hahn, Rebecca T; Herrmann, Howard C; Reisman, Mark; Whisenant, Brian; Lim, Scott; Beohar, Nirat; Mack, Michael; Teirstein, Paul; Rihal, Charanjit; Douglas, Pamela S; Blackstone, Eugene; Pichard, Augusto; Webb, John G; Leon, Martin B

    2013-07-30

    This study investigated the determinants and outcomes of acute insertion of a second transcatheter prosthetic valve (TV) within the first (TV-in-TV) or transcatheter valve embolization (TVE) after transcatheter aortic valve replacement (TAVR). TAVR failure can occur with both TV-in-TV and TVE as a consequence of TAVR malpositioning. Only case reports and limited series pertaining to these complications have been reported to date. Patients undergoing TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve) randomized trial (cohorts A and B) and accompanying registries were studied. Data were dichotomized for those with and without TV-in-TV or TVE, respectively. From a total of 2,554 consecutive patients, 63 (2.47%) underwent TV-in-TV and 26 (1.01%) TVE. The indication for TV-in-TV was significant aortic regurgitation in most patients, often due not only to malpositioning but also to leaflet dysfunction. Despite similar aortic valve function on follow-up echoes, TV-in-TV was an independent predictor of 1-year cardiovascular mortality (hazard ratio [HR]: 1.86, 95% confidence interval [CI]: 1.03 to 3.38, p = 0.041), with a nonsignificant trend toward greater all-cause mortality (HR: 1.43, 95% CI: 0.88 to 2.33, p = 0.15). Technical and anatomical reasons accounted for most cases of TVE. A multivariable analysis found TVE to be an independent predictor of 1-year mortality (HR: 2.68, 95% CI: 1.34 to 5.36, p = 0.0055) but not cardiovascular mortality (HR: 1.30, 95% CI: 0.48 to 3.52, p = 0.60). Acute TV-in-TV and TVE are serious sequelae of TAVR, often resulting in multiple valve implants. They carry an excess of mortality and are caused by anatomic and technical factors, which may be avoidable with judicious procedural planning. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  7. Optimal C-arm angulation during transcatheter aortic valve replacement: Accuracy of a rotational C-arm computed tomography based three dimensional heart model

    PubMed Central

    Veulemans, Verena; Mollus, Sabine; Saalbach, Axel; Pietsch, Max; Hellhammer, Katharina; Zeus, Tobias; Westenfeld, Ralf; Weese, Jürgen; Kelm, Malte; Balzer, Jan

    2016-01-01

    AIM To investigate the accuracy of a rotational C-arm CT-based 3D heart model to predict an optimal C-arm configuration during transcatheter aortic valve replacement (TAVR). METHODS Rotational C-arm CT (RCT) under rapid ventricular pacing was performed in 57 consecutive patients with severe aortic stenosis as part of the pre-procedural cardiac catheterization. With prototype software each RCT data set was segmented using a 3D heart model. From that the line of perpendicularity curve was obtained that generates a perpendicular view of the aortic annulus according to the right-cusp rule. To evaluate the accuracy of a model-based overlay we compared model- and expert-derived aortic root diameters. RESULTS For all 57 patients in the RCT cohort diameter measurements were obtained from two independent operators and were compared to the model-based measurements. The inter-observer variability was measured to be in the range of 0°-12.96° of angular C-arm displacement for two independent operators. The model-to-operator agreement was 0°-13.82°. The model-based and expert measurements of aortic root diameters evaluated at the aortic annulus (r = 0.79, P < 0.01), the aortic sinus (r = 0.93, P < 0.01) and the sino-tubular junction (r = 0.92, P < 0.01) correlated on a high level and the Bland-Altman analysis showed good agreement. The interobserver measurements did not show a significant bias. CONCLUSION Automatic segmentation of the aortic root using an anatomical model can accurately predict an optimal C-arm configuration, potentially simplifying current clinical workflows before and during TAVR. PMID:27847562

  8. Subacute Subclinical Brain Infarctions after Transcatheter Aortic Valve Implantation Negatively Impact Cognitive Function in Long-Term Follow-Up

    PubMed Central

    Schulze-Hagen, Leonie; Müller, Andreas; Wilsing, Marius; Sinning, Jan-Malte; Lütkens, Julian; Frerker, Christian; Kuck, Karl-Heinz; Gräff, Ingo; Schild, Hans; Werner, Nikos; Grube, Eberhard; Nickenig, Georg

    2017-01-01

    Aims To date every post-procedural cerebrovascular embolic event (CVE) is dreaded for its potential to accelerate cognitive decline after transcatheter aortic valve implantation (TAVI). This study differentiates the impact of acute (procedural) and post-acute cerebrovascular embolic events (CVEs) on cognitive performance. Methods Magnetic resonance imaging (MRI) before, early and late after TAVI was performed to quantify embolic burden. Quantification of diffusion- and T1-weighted lesions, as well as white-matter and total brain volumes, as well as cognitive function testing (MMSE) were assessed in 28 patients with a medium follow-up period of 34 months. Results Procedural diffusion-weighted lesions were observed in 17 patients (61%), but demonstrated locoregional remnants only in a minority of patients in long-term follow-up (6.5%). Acute CVEs did not impact the trajectory of late silent brain infarctions (SBI), white-matter hyperintensities, and cerebral atrophy. Functionally, early CVEs did not affect cognitive function. In contrast, patients with “new” SBIs after TAVI had a trend to cognitive deterioration in long-term follow-up (“new”SBI: MMSE -1.4 / no “new”SBI: MMSE +1.5, p = 0.067). Interestingly, only a fraction of these “new” SBIs evolved from procedural CVEs (22.2%). Conclusions Aquired SBIs after TAVI, but not DW-CVE per se are associated with functional impairment long-term after TAVI. In the context of subacute thrombosis seen in TAVI prostheses, these findings set the stage for tailored stroke prevention and comprehensive surrogate endpoint definitions in neuroprotective trials. PMID:28056466

  9. Association between implantation depth assessed by computed tomography and new-onset conduction disturbances after transcatheter aortic valve implantation.

    PubMed

    Almeida, João Gonçalves; Ferreira, Sara Moura; Fonseca, Paulo; Dias, Tiago; Guerreiro, Cláudio; Barbosa, Ana Raquel; Teixeira, Pedro; Carvalho, Mónica; Ferreira, Wilson; Ferreira, Nuno Dias; Oliveira, Marco; Gonçalves, Helena; Braga, Pedro; Ribeiro, José; Primo, João; Ribeiro, Vasco Gama

    Transcatheter aortic valve replacement (TAVR) is often associated with intraventricular conduction disturbances. We aimed to determine the association between implantation depth assessed by multidetector computed tomography (MDCT) and new-onset conduction abnormalities after TAVR. Retrospective single-center study including patients consecutively submitted to TAVR, between August/2007 and October/2016, who underwent routine MDCT 3 months after the procedure. The endpoint of conduction disturbances included permanent pacemaker implantation and/or new-onset left bundle-branch block. Implantation depth was determined as the distance between the ventricular end of the prothesis and the native ring, at the level of the non-coronary cusp. 138 patients were included (female gender 52.2%, mean age 78.7 ± 6.9 years). The EuroSCORE II was 4.0 ± 3.9% and 57.2% were treated with self-expanding prosthesis. The endpoint of conduction abnormalities was found in 45.7% (n = 63). The implantation depth was greater in the group with conduction disturbances (7.7 vs 6.4 mm, p = 0.006). Chronic obstructive pulmonary disease, oversizing and implantation depth were independent predictors of conduction abnormalities. Implantation depth had an AUC of 0.64 (p = 0.004) for the prediction of conduction abnormalities and a cut-off value of 7.1 mm predicted the composed endpoint with a sensitivity and specificity of 65% and 70%, respectively. Implantation depth assessed by MDCT is associated with new-onset conduction disturbances after TAVR. In patients with conduction abnormalities, which do not qualify for the immediate implantation of pacemaker, the assessment of implantation depth by MDCT may be an additional marker of risk to aid decision-making. Copyright © 2017 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

  10. The relationship between chronic obstructive pulmonary disease and transcatheter aortic valve implantation--A systematic review and meta-analysis.

    PubMed

    Liao, Yan-Biao; He, Ze-Xia; Zhao, Zhen-Gang; Wei, Xin; Zuo, Zhi-Liang; Li, Yi-Jian; Xiong, Tian-Yuan; Xu, Yuan-Ning; Feng, Yuan; Chen, Mao

    2016-03-01

    The present study was performed to investigate the relationship between chronic obstructive pulmonary disease (COPD) and transcatheter aortic valve implantation (TAVI). Controversies regarding the relationship between COPD and TAVI have intensified. A literature review of the PubMed online database was performed, and articles published between January 1, 2002 and March 20, 2015 were analyzed. Random-effect and fixed-effect models were used, depending on the between-study heterogeneity. A total of 28 studies, involving 51,530 patients, were identified in our review. The burden of COPD ranged from 12.5% to 43.4%, and COPD negatively impacted both short-term and long-term all-cause survival (30 days: odds ratio [OR], 1.43, 95% CI, 1.14-1.79; >2 years: hazard ratio [HR], 1.34, 95% CI, 1.12-1.61). COPD was also associated with increased short-term and mid-term cardiac-cause mortality (30 days: OR, 1.29, 95% CI, 1.02-1.64; 1 year: HR: 1.09, 1.02-1.17). Moreover, COPD (OR, 1.97, 95% CI, 1.29-3.0) predicted post-TAVI acute kidney disease. Importantly, chronic kidney disease (CKD) (HR, 1.2, 95% CI, 1.1-1.32) and the distance of the 6 minute walk test (6MWT) (HR, 1.16, 1.06-1.27) predicted TAVI futility in patients with COPD. COPD is common among patients undergoing TAVI, and COPD impacts both short- and long-term survival. COPD patients, who had a lower BMI, shorter distance of 6MWT and CKD, were at higher risk for TAVI futility. © 2016 Wiley Periodicals, Inc.

  11. Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Success and safety.

    PubMed

    Minha, Sa'ar; Waksman, Ron; Satler, Lowell P; Torguson, Rebecca; Alli, Oluseun; Rihal, Charanjit S; Mack, Michael; Svensson, Lars G; Rajeswaran, Jeevanantham; Blackstone, Eugene H; Tuzcu, E Murat; Thourani, Vinod H; Makkar, Raj; Ehrlinger, John; Lowry, Ashley M; Suri, Rakesh M; Greason, Kevin L; Leon, Martin B; Holmes, David R; Pichard, Augusto D

    2016-01-01

    To identify number of cases needed to maximize device success and minimize adverse events after transfemoral transcatheter aortic valve replacement (TF-TAVR), and determine if adverse events were linked to the technical performance learning curve. TF-TAVR is a complex procedure with an incompletely characterized learning curve for clinical outcomes. From 4/2007-2/2012, 1521 patients underwent TF-TAVR in the PARTNER-I trial. Outcomes learning curves were defined as number of cases needed to reach a plateau for device success, adverse events, and post-procedure length of stay. Institutional variation was accounted for by mixed-model non-linear techniques, which were also used to identify contribution of the procedure time learning curve to 30-day major adverse events and length of stay. Eighty percent device success was achieved after 22 cases; major vascular complications fell below 5% after 70 cases and major bleeding below 10% after 25 cases. It took an average of 28 cases to achieve a consistent low risk of 30-day major adverse events, but institutions entering in the middle of the trial achieved it after about 26. The most significant correlate of 30-day major adverse events and post-procedure length of stay was procedure time (P < 0.0001). However, this association was related to patient and unmeasured variables, not the procedure time learning curve (P = 0.6). By end of trial, a consistent low risk of adverse events was achieved after ∼26 cases. However, these improved results were due to change in patient risk profile; outcomes were not linked to the technical performance learning curve. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  12. Contemporary transcatheter aortic valve replacement with third-generation balloon-expandable versus self-expanding devices.

    PubMed

    Rogers, Toby; Steinvil, Arie; Buchanan, Kyle; Alraies, M Chadi; Koifman, Edward; Gai, Jiaxiang; Torguson, Rebecca; Okubagzi, Petros; Ben-Dor, Itsik; Pichard, Augusto; Satler, Lowell; Waksman, Ron

    2017-08-01

    To evaluate balloon-expandable and self-expanding third-generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes. Two competing third-generation TAVR technologies are currently commercially available in the US. There are no published head-to-head comparisons of the relative performance of these two devices. 257 consecutive patients undergoing TAVR with a third-generation balloon-expandable (Edwards Sapien 3) or self-expanding device (Medtronic CoreValve Evolut R) at a single US medical center were included. Choice of TAVR device was at the discretion of the multidisciplinary Heart Team. Baseline clinical characteristics, echocardiographic and CT imaging, procedural and 30-day outcomes were prospectively collected. 74 patients received a self-expanding valve (SEV) and 183 received a balloon-expandable valve (BEV). Patients selected for SEV were more frequently women, with lower body surface area and smaller calcified iliofemoral arteries. Three SEV patients required implantation of a second valve to successfully treat paravalvular leak. Only one BEV patient had moderate paravalvular regurgitation. There was no difference in the rate of stroke, major vascular complication or bleeding. Permanent pacemaker implantation rate was significantly higher with SEV (12.7% vs 4.7%, P = 0.49) and hospital length of stay was longer (8.3% vs 6.5%, P = 0.043), but 30-day mortality was comparable (1.4% vs 1.6%, P = 1.00). Short-term outcomes were equivalent between the two technologies. Clinically significant paravalvular regurgitation was rare. SEV were more frequently selected in women and patients with challenging transfemoral access, but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay. © 2017, Wiley Periodicals, Inc.

  13. Soluble ST2 for Risk Stratification and the Prediction of Mortality in Patients Undergoing Transcatheter Aortic Valve Implantation.

    PubMed

    Stundl, Anja; Lünstedt, Nina-Sophie; Courtz, Florian; Freitag-Wolf, Sandra; Frey, Norbert; Holdenrieder, Stefan; Zur, Berndt; Grube, Eberhard; Nickenig, Georg; Werner, Nikos; Frank, Derk; Sinning, Jan-Malte

    2017-09-15

    This study aimed to assess the prognostic value of soluble ST2 (sST2) for risk stratification in patients undergoing transcatheter aortic valve implantation (TAVI). In 461 patients undergoing TAVI, sST2 was determined at baseline and categorized into quartiles. An optimum cutoff of 29 ng/ml was calculated. Primary end point was 1-year all-cause mortality. Results were validated in an independent cohort. Patients with sST2 >29 ng/ml had an increased 30-day (9.7% vs 4.6%, p = 0.043) and 1-year mortality (38.1% vs 21.8%, p = 0.001). In accordance, patients with N-terminal pro-brain natriuretic peptide (NT-proBNP) >8145 pg/ml revealed a comparable 30-day mortality (7.9% vs 4.7%, p = 0.189) and 1-year mortality (39.5% vs 21.0%, p <0.001). In univariate regression analysis, sST2 and NT-proBNP were associated with increased mortality risk. In multivariate regression analysis, independent predictors of mortality were logistic EuroSCORE, chronic renal failure, left ventricular ejection fraction, and sST2. In receiver operating characteristic curve analysis, sST2 did not provide incremental prognostic information beyond that obtained from surgical risk scores such as the STS-PROM or NT-proBNP. Similar findings could be achieved in an independent validation cohort. In conclusion, sST2 is independently associated with adverse outcome after TAVI but was not superior to NT-proBNP or surgical risk scores for the prediction of postprocedural outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Surgical cutdown versus percutaneous access in transfemoral transcatheter aortic valve implantation: Insights from the Brazilian TAVI registry.

    PubMed

    Bernardi, Fernando L M; Gomes, Wilton F; de Brito, Fabio S; Mangione, Jose A; Sarmento-Leite, Rogério; Siqueira, Dimitry; Carvalho, Luiz A; Tumelero, Rogério; Guerios, Enio E; Lemos, Pedro A

    2015-09-01

    To compare the 1-year outcomes of complete percutaneous approach versus surgical vascular approach for transfemoral transcatheter aortic valve implantation (TAVI), among "real-world" patients from the multi-center Brazilian TAVI registry. Vascular access still remains a major challenge for TAVI via transfemoral approach. Vascular access through complete percutaneous approaches or through open surgical vascular techniques seems to be acutely similar. However, the long-term outcomes of both techniques remain poorly described. The study population comprised all patients treated via transfemoral route in the Brazilian TAVI registry, a "real-world", nation-based, multi-center study. Patients were divided according to the initial vascular access approach (percutaneous vs. surgical) and clinically followed-up for 1 year. The primary endpoint was the incidence of combined adverse events all-cause mortality, life-threatening bleeding, and/or major vascular complication at 1 year. A total of 402 patients from 18 centers comprised the study population (percutaneous approach in 182 patients; surgical cutdown approach 220 patients). The incidence of combined adverse events was not different in the percutaneous and the surgical groups at 30 days (17.6% vs. 16.3%; P = 0.8) and at 1 year (primary endpoint) (30.9% vs. 28.8%; P = 0.8). Also, the study groups overall were comparable regarding the incidence of each individual safety adverse events at 30 days and at 1 year. Total percutaneous techniques or surgical cutdown and closure may provide similar safety and effectiveness during the first year of follow-up in patients undergoing transfemoral TAVI. © 2015 Wiley Periodicals, Inc.

  15. 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.

  16. Outcomes, readmissions, and costs in transfemoral and alterative access transcatheter aortic valve replacement in the US Medicare population.

    PubMed

    McCarthy, Fenton H; Spragan, Danielle D; Savino, Danielle; Dibble, Taylor; Hoedt, Ashley C; McDermott, Katherine M; Bavaria, Joseph E; Herrmann, Howard C; Anwaruddin, Saif; Giri, Jay; Szeto, Wilson Y; Groeneveld, Peter W; Desai, Nimesh D

    2017-10-01

    To comprehensively evaluate and compare utilization, outcomes, and especially costs of transfemoral (TF), transapical (TA), and transaortic (TAO) transcatheter aortic valve replacement (TAVR). All Medicare fee-for-service patients undergoing TF (n = 4065), TA (n = 691), or TAO (n = 274) TAVR between January 1, 2011, and November 30, 2012, were identified using Health Care Procedure Classification Codes present on Medicare claims. Hospital charges from Medicare claims were converted to costs using hospital-specific Medicare cost-to-charge ratios. TA and TAO patients were similar in age, race, and common comorbidities. Compared with TF patients, TA and TAO patients were more likely to be female and to have peripheral vascular disease, chronic lung disease, and renal failure. Thirty-day mortality rates were higher among TA and TAO patients than among TF patients (TA, 9.6%; TAO, 8.0%; TF, 5.0%; P < .001). Adjusted mortality beyond 1 year did not differ by access. TA patients were more likely to require cardiopulmonary bypass (CPB). Increased adjusted mortality was associated with CPB (hazard ratio, 2.13; P < .01) and increased 30-day cost ($62,000 [interquartile range (IQR)], $45,100-$86,400 versus $48,800 [IQR, $38,100-$62,900]; P < .01). Cost at 30 days was lowest for TF ($48,600) compared with TA ($49,800; P < .01) and TAO ($53,200; P = .03). For patients ineligible to receive TF TAVR, TAO and TA approaches offer similar clinical outcomes at similar cost with acceptable operative and 1-year survival, except for higher rates of CPB use in TA patients. CPB was associated with worse survival and increased costs. Copyright © 2017. Published by Elsevier Inc.

  17. Emergency and prophylactic use of miniaturized veno-arterial extracorporeal membrane oxygenation in transcatheter aortic valve implantation.

    PubMed

    Husser, Oliver; Holzamer, Andreas; Philipp, Alois; Nunez, Julio; Bodi, Vicente; Müller, Thomas; Lubnow, Matthias; Luchner, Andreas; Lunz, Dirk; Riegger, Günter A J; Schmid, Christof; Hengstenberg, Christian; Hilker, Michael

    2013-10-01

    To report our center's experience using veno-arterial extracorporeal membrane oxygenation (vaECMO) in transcatheter aortic valve implantation (TAVI). In TAVI, short-term mortality closely relates to life threatening procedural complications. VaECMO can be used to stabilize the patient in emergency situations. However, for the prophylactic use of vaECMO in very high-risk patients undergoing TAVI there is no experience. From January 2009 to August 2011, we performed 131 TAVI. Emergency vaECMO was required in 8 cases (7%): ventricular perforation (n = 3), hemodynamic instability/cardiogenic shock (n = 4), hemodynamic deterioration due to ventricular tachycardia (n = 1). Since August 2011, during 83 procedures, prophylactic vaECMO was systematically used in very high-risk patients (n = 9, 11%) and emergency ECMO in one case (1%) due to ventricular perforation. Median logistic EuroScore in prophylactic vaECMO patients was considerably higher as compared to the remaining TAVI population (30% vs. 15%, P = 0.0003) while in patients with emergency vaECMO it was comparable (18% vs. 15%, P = 0.08). Comparing prophylactic to emergency vaECMO, procedural success and 30-day mortality were 100% vs. 44% (P = 0.03) and 0% vs. 44% (P = 0.02), respectively. Major vascular complications and rate of life threatening bleeding did not differ between both groups (11% vs. 11%, P = 0.99 and 11% vs. 33%, P = 0.3) and were not vaECMO-related. Life-threatening complications during TAVI can be managed using emergency vaECMO but mortality remains high. The use of prophylactic vaECMO in very high-risk patients is safe and may be advocated in selected cases. Copyright © 2013 Wiley Periodicals, Inc.

  18. Early and late changes in quality of life following transcatheter aortic valve implantation using the transfemoral and transapical approaches.

    PubMed

    Bona, Veronica; Khawaja, Muhammed Z; Bapat, Vinayak; Young, Christopher; Hancock, Jane; Redwood, Simon; Fusari, Melissa; Thomas, Martyn

    2015-06-01

    To evaluate the effects of access route upon clinical results and quality of life (QoL) in patients undergoing either transfemoral (TF-TAVI) or transapical balloon-expandable transcatheter aortic valve implantation (TA-TAVI) in the real world. A prospective analysis was performed upon 264 consecutive patients receiving TF-TAVI or TA-TAVI. QoL was assessed using the EQ-5D questionnaire. At baseline, TA-TAVI patients reported significantly more problems in mobility, self-care, usual activities and lower overall health status domains (p<0.01 for all). At 30 days, the TF-TAVI group reported fewer problems with usual activity (p=0.01) and pain/discomfort (p<0.01), and higher EQ-5D index and visual analogue scale (VAS) (p=0.01 and p<0.01, respectively) than the TA-TAVI group. Nevertheless, the absolute improvements (ΔEQ-5D index and ΔEQ-5D VAS) were larger in the TA-TAVI group, with most dramatically marked QoL absolute improvements (p<0.01 and p=0.02, respectively). By one year, notwithstanding higher all-cause mortality in the sicker TA-TAVI group, there were no differences between groups in any EQ-5D domain. Indeed, surviving TA-TAVI group's greater absolute improvements remained (p<0.01). QoL is greater at the earlier time point of 30 days in the TF-TAVI cohort but equatable by one year. However, the magnitude of improvement in QoL is greater in the TA-TAVI patients at both 30 days and one year.

  19. Dual Versus Single Antiplatelet Regimen With or Without Anticoagulation in Transcatheter Aortic Valve Replacement: Indirect Comparison and Meta-analysis.

    PubMed

    Verdoia, Monica; Barbieri, Lucia; Nardin, Matteo; Suryapranata, Harry; De Luca, Giuseppe

    2017-07-19

    There is uncertainty on the correct management of antithrombotic therapies after transcatheter aortic valve replacement (TAVR), with dual antiplatelet therapy (DAPT) being currently recommended on an empirical basis. The aim of the present meta-analysis was to assess the safety and effectiveness of DAPT in patients undergoing TAVR. Studies comparing different antithrombotic regimens after TAVR were included. The primary endpoint was 30-day overall mortality. We included 9 studies, 5 comparing DAPT with aspirin monotherapy and 4 comparing DAPT with monoantiplatelet therapy (MAPT) + oral anticoagulation. Among 7991 patients, 72% were on DAPT. The median follow-up was 3.5 months. Mortality was significantly lower in the DAPT group (12.2% vs 14.4%; OR, 0.81; 95%CI, 0.70-0.93; P = .003; Phet = .93), with similar benefits compared with aspirin monotherapy (OR, 0.80; 95%CI, 0.69-0.93; P = .004; Phet = .60), which were not statistically significant when compared with MAPT + oral anticoagulation (OR, 0.86; 95%CI, 0.55-1.35; P = .51; Phet = .97). A similar trend for DAPT was observed for stroke (OR, 0.83 95%CI, 0.63-1.10; P = .20; Phet = .67), with no increase in the rate of major bleedings (OR, 1.69; 95%CI, 0.86-3.31; P = .13; Phet< .0001). On indirect comparison analysis, no benefit in survival, stroke, or bleedings was identified for additional oral anticoagulation. The present meta-analysis supports the use of DAPT after TAVR, reducing mortality and offering slight benefits in stroke, with no increase in major bleedings compared with MAPT. The strategy of aspirin + oral anticoagulation did not provide significant benefits compared with MAPT or DAPT. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  20. Learning curves for transapical transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance, success, and safety.

    PubMed

    Suri, Rakesh M; Minha, Sa'ar; Alli, Oluseun; Waksman, Ron; Rihal, Charanjit S; Satler, Lowell P; Greason, Kevin L; Torguson, Rebecca; Pichard, Augusto D; Mack, Michael; Svensson, Lars G; Rajeswaran, Jeevanantham; Lowry, Ashley M; Ehrlinger, John; Mick, Stephanie L; Tuzcu, E Murat; Thourani, Vinod H; Makkar, Raj; Holmes, David; Leon, Martin B; Blackstone, Eugene H

    2016-09-01

    Introduction of hybrid techniques, such as transapical transcatheter aortic valve replacement (TA-TAVR), requires skills that a heart team must master to achieve technical efficiency: the technical performance learning curve. To date, the learning curve for TA-TAVR remains unknown. We therefore evaluated the rate at which technical performance improved, assessed change in occurrence of adverse events in relation to technical performance, and determined whether adverse events after TA-TAVR were linked to acquiring technical performance efficiency (the learning curve). From April 2007 to February 2012, 1100 patients, average age 85.0 ± 6.4 years, underwent TA-TAVR in the PARTNER-I trial. Learning curves were defined by institution-specific patient sequence number using nonlinear mixed modeling. Mean procedure time decreased from 131 to 116 minutes within 30 cases (P = .06) and device success increased to 90% by case 45 (P = .0007). Within 30 days, 354 patients experienced a major adverse event (stroke in 29, death in 96), with possibly decreased complications over time (P ∼ .08). Although longer procedure time was associated with more adverse events (P < .0001), these events were associated with change in patient risk profile, not the technical performance learning curve (P = .8). The learning curve for TA-TAVR was 30 to 45 procedures performed, and technical efficiency was achieved without compromising patient safety. Although fewer patients are now undergoing TAVR via nontransfemoral access, understanding TA-TAVR learning curves and their relationship with outcomes is important as the field moves toward next-generation devices, such as those to replace the mitral valve, delivered via the left ventricular apex. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  1. Frequency and Effect of Access-Related Vascular Injury and Subsequent Vascular Intervention After Transcatheter Aortic Valve Replacement.

    PubMed

    Dencker, Ditte; Taudorf, Mikkel; Luk, N H Vincent; Nielsen, Michael B; Kofoed, Klaus F; Schroeder, Torben V; Søndergaard, Lars; Lönn, Lars; De Backer, Ole

    2016-10-15

    Vascular access and closure remain a challenge in transcatheter aortic valve replacement (TAVR). This single-center study aimed to report the incidence, predictive factors, and clinical outcomes of access-related vascular injury and subsequent vascular intervention. During a 30-month period, 365 patients underwent TAVR and 333 patients (94%) were treated by true percutaneous transfemoral approach. Of this latter group, 83 patients (25%) had an access-related vascular injury that was managed by the use of a covered self-expanding stent (n = 49), balloon angioplasty (n = 33), or by surgical intervention (n = 1). In 16 patients (5%), the vascular injury was classified as a major vascular complication. Absence of a preprocedural computed tomography angiography (CTA) of the iliofemoral arteries (OR 2.04, p = 0.007) and female gender (OR 2.18, p = 0.004) were independent predictors of the need for access-related vascular intervention. In addition, a high sheath/common femoral artery ratio as measured on preoperative CTA was associated with a higher rate of post-TAVR vascular intervention. The radiation dose, iodine contrast volume, transfusion need, length of hospitalization, and 30-day mortality were not significantly different between patients with versus without access-related vascular intervention. In conclusion, access-related vascular intervention in patients who underwent transfemoral-TAVR is not uncommon. Female gender and a high sheath/common femoral artery ratio are risk factors for access-related vascular injury, whereas preprocedural planning with CTA of the access vessels may reduce the risk of vascular injury. Importantly, most access-related vascular injuries may be treated by percutaneous techniques with similar clinical outcomes to patients without vascular injuries. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Impact of routine crossover balloon occlusion technique on access-related vascular complications following transfemoral transcatheter aortic valve replacement.

    PubMed

    Zaman, Sarah; Gooley, Robert; Cheng, Victoria; McCormick, Liam; Meredith, Ian T

    2016-08-01

    To determine the impact of incorporating routine crossover balloon occlusion technique (CBOT) for vascular access closure following transcatheter aortic valve replacement (TAVR) on major access-site-related complications. Vascular complications are associated with increased mortality following TAVR. The CBOT involves passage of a balloon catheter from the contralateral femoral artery to enable controlled closure of large-sheath access-sites. Consecutive patients who underwent transfemoral TAVR as part of three clinical trials were prospectively recruited. Patients who had routine CBOT (CBOT group, n = 55) were compared to preceding patients who did not undergo CBOT (control group, n = 43). The primary endpoint was 30-day occurrence of access-site-related Valve Academic Research Consortium (VARC)-2 defined major vascular and/or bleeding complications. CBOT was successfully performed in 96% with 2% occurrence of a minor CBOT-related complication. At 30-days access-site-related major vascular and/or bleeding occurred in 5.5% and 18.6% of the CBOT and control group, respectively (P = 0.042). This consisted of VARC-2 major vascular events in 3.6% and 16.3% (P = 0.036) and VARC-2 major/life-threatening bleeding events in 5.5% and 14.0% (P = 0.137) of the CBOT and control group, respectively. Transfusion of ≥2 units of packed red blood cells were required in 10.9% and 30.2% of the CBOT and control group, respectively (P = 0.016). There was no significant difference in contrast load, procedure time, and kidney injury between the two groups. Routine CBOT for TAVR access-site closure has a high success rate and is associated with a significant reduction in VARC-2 major vascular and bleeding complications compared to TAVR performed without CBOT. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  3. Arrhythmia burden in elderly patients with severe aortic stenosis as determined by continuous electrocardiographic recording: toward a better understanding of arrhythmic events after transcatheter aortic valve replacement.

    PubMed

    Urena, Marina; Hayek, Salim; Cheema, Asim N; Serra, Vicenç; Amat-Santos, Ignacio J; Nombela-Franco, Luis; Ribeiro, Henrique B; Allende, Ricardo; Paradis, Jean-Michel; Dumont, Eric; Thourani, Vinod H; Babaliaros, Vasilis; Francisco Pascual, Jaume; Cortés, Carlos; Del Blanco, Bruno García; Philippon, François; Lerakis, Stamatios; Rodés-Cabau, Josep

    2015-02-03

    This study sought to evaluate the prevalence of previously undiagnosed arrhythmias in candidates for transcatheter aortic valve replacement (TAVR) and to determine the impact on therapy changes and arrhythmic events after the procedure. A total of 435 candidates for TAVR underwent 24-hour continuous ECG monitoring the day before the procedure. Newly diagnosed arrhythmias were observed in 70 patients (16.1%) before TAVR: paroxysmal atrial fibrillation (AF)/atrial tachycardia (AT) in 28, advanced atrioventricular block or severe bradycardia in 24, nonsustained ventricular tachycardia in 26, and intermittent left bundle-branch block in 3 patients. All arrhythmic events but one were asymptomatic and led to a therapy change in 43% of patients. In patients without known AF/AT, the occurrence of AF/AT during 24-hour ECG recording was associated with a higher rate of 30-day cerebrovascular events (7.1% versus 0.4%; P=0.030). Among the 53 patients with new-onset AF/AT after TAVR, 30.2% had newly diagnosed paroxysmal AF/AT before the procedure. In patients who needed permanent pacemaker implantation after the procedure (n=35), 31.4% had newly diagnosed advanced atrioventricular block or severe bradycardia before TAVR. New-onset persistent left bundle-branch block after TAVR occurred in 37 patients, 8.1% of whom had intermittent left bundle-branch block before the procedure. Newly diagnosed arrhythmias were observed in approximately a fifth of TAVR candidates, led to a higher rate of cerebrovascular events, and accounted for a third of arrhythmic events after the procedure. This high arrhythmia burden highlights the importance of an early diagnosis of arrhythmic events in such patients to implement the appropriate therapeutic measures earlier. © 2014 American Heart Association, Inc.

  4. Gender-related differences on short- and long-term outcomes of patients undergoing transcatheter aortic valve implantation.

    PubMed

    Katz, Marcelo; Carlos Bacelar Nunes Filho, Antonio; Caixeta, Adriano; Antonio Carvalho, Luiz; Sarmento-Leite, Rogério; Alves Lemos Neto, Pedro; Eduardo Koenig São Thiago, Luiz; Dias Dourado Oliveira, Adriano; Antonio Marino, Marcos; Tadeu Tumelero, Rogerio; Antonio Perin, Marco; Abizaid, Alexandre; Tarasoutchi, Flavio; Sândoli de Brito, Fábio

    2017-02-15

    This study aimed to compare gender-related differences in outcomes of patients undergoing TAVI over a long-term follow-up period. Transcatheter aortic valve implantation (TAVI) has been considered the standard therapy for patients with inoperable or high-risk symptomatic aortic stenosis. The influence of gender-related differences in outcomes of patients undergoing TAVI is currently on debate. From January 2008 to January 2015, 819 patients (49% men) underwent TAVI and were included in a multicenter Brazilian registry. Patients were followed-up and clinical outcomes were evaluated according to the updated Valve Academic Research Consortium-2 criteria. Mean follow-up was 497 ± 478 days. Compared with women, men had a lower rate of major or life-threatening bleeding (12.0% vs. 20.6%; HR = 0.57 [95CI% 0.40-0.81]; P = 0.001), and major vascular complications (6% vs. 11.7%; HR = 0.50 [95CI% 0.31-0.82]; P = 0.004). At 30 days, all-cause mortality was lower in men than in women (6.5% vs. 11.5%; P = 0.013), however, cumulative all-cause mortality was similar between groups (25.9% vs. 29.7%, men and women, respectively, HR = 0.92 [95CI% 0.71-1.19]; P = 0.52) over the entire follow-up period. By adjusted Cox regression model, renal function, diabetes, peripheral artery disease, and chronic obstructive pulmonary disease (COPD) remained independently predictors of all-cause mortality. In this large-scale study evaluating patients undergoing TAVI, 30-day mortality was higher among women than men driven by significant higher rates of major or life-threatening bleeding and major vascular complications. However, all-cause mortality on long-term follow-up was similar between groups. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  5. Impact of mitral geometry and global afterload on improvement of mitral regurgitation after trans-catheter aortic valve implantation

    PubMed Central

    Dworakowski, R; Kogoj, P; Reiken, J; Kenny, C; MacCarthy, P; Wendler, O; Monaghan, M J

    2016-01-01

    Objective To assess the impact of mitral geometry, left ventricular (LV) remodelling and global LV afterload on mitral regurgitation (MR) after trans-catheter aortic valve implantation (TAVI). Methods In this study, 60 patients who underwent TAVI were evaluated by 3D echocardiography at baseline, 1 month and 6 months after procedure. The proportional change in MR following TAVI was determined by examining the percentage change in vena contracta (VC) at 6 months. Patients having a significant reduction of at least 30% in VC were defined as good responders (GR) and the remaining patients were defined as poor responders (PR). Results After 6 months of TAVI, 27 (45%) patients were GR and 33 (55%) were PR. There was a significant decrease in 3DE-derived mitral annular diameter and area (P = 0.001), mitral valve tenting area (TA) (P = 0.05), and mitral papillary muscle dyssynchrony index (DSI) (P = 0.05) in the GR group. 3DE-derived LVESV (P = 0.016), LV mass (P = 0.001) and LV DSI, (P = 0.001) were also improved 6 months after TAVI. In addition, valvulo-arterial impedance (ZVA) was significantly higher at baseline in patients with PR (P = 0.028). 3DE-derived mitral annular area (β: 0.47, P = 0.04), mitral papillary DSI (β: −0.65, P = 0.012) and ZVA (β: 0.45, P = 0.028) were the strongest independent parameters that could predict the reduction of functional MR after TAVI. Conclusion GR patients demonstrate more regression in mitral annulus area and diameter after significant decrease in high LVEDP and trans-aortic gradients with TAVI. PR patients appear to have increased baseline ZVA, mitral valve tenting and restriction in mitral valve coaptation. These factors are important for predicting the impact of TAVI on pre-existing MR. PMID:27457965

  6. 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

  7. Transcatheter repair of Fontan baffle stenosis and fenestration in two patients using Cook Zenith aortic endografts.

    PubMed

    Madan, Nitin; Ellozy, Sharif; Love, Barry

    2012-02-01

    Patients with Fontan baffles for single ventricle may have cyanosis from right-to-left shunt through leaks in the baffle or due to intentionally created fenestrations. Typically this right-to-left shunt may be addressed with catheter-based occlusion devices. However, in narrowing of the Fontan baffle, placement of occluders within the Fontan baffle may additionally narrow the pathway and is therefore undesirable. We describe 2 patients with the combination of Fontan baffle stenosis and patent fenestration treated with a Zenith abdominal aortic aneurysm endograft (Cook Medical). The covered stent graft both occluded the right-to-left shunt and eliminated the baffle stenosis. Both patients have had symptomatic improvement.

  8. Successful Transcatheter Embolization of Penetrating Aortic Ulcer Using Interlocking Detachable Coils

    SciTech Connect

    Hama, Yukihiro; Kaji, Tatsumi; Iwasaki, Yoshie; Hinokiyama, Kazuhiro; Shimizu, Masafumi; Kusano, Shoichi

    2000-09-15

    A 54-year-old man with persistent chest pain was hospitalized for hypertension and DeBakey type IIIb aortic dissection. The false lumen of the dissection was almost completely thrombosed; however, a penetrating atherosclerotic ulcer (PAU) was observed 5 weeks later. At that time, we successfully embolized the PAU with a microcatheter and interlocking detachable coils (IDCs). The patient is well with no episodes of relapse in 20 months of follow-up. This case suggests the utility of the microcatheter and IDC system as an alternative to surgery.

  9. 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.

  10. Optimization of acquisition and contrast injection protocol for C-arm CT imaging in transcatheter aortic valve implantation: initial experience in a swine model.

    PubMed

    Numburi, Uma D; Kapadia, Samir R; Schoenhagen, Paul; Tuzcu, E Murat; von Roden, Martin; Halliburton, Sandra S

    2013-02-01

    To determine the optimal C-arm computed tomography (CT) protocol for transcatheter aortic valve implantation (TAVI) in swine. In 6 swine, C-arm CT was performed using 5-s ungated acquisition during sinus rhythm with aortic root (Method 1) or peripheral (Method 2) injection, and during rapid ventricular pacing with root injection (Method 3). Additionally, 24-s ECG-gated acquisitions were performed during sinus rhythm with root (Method 4) or peripheral (Method 5) injection. Aortic root enhancement, presence of artifacts and contrast volumes were compared for all methods. Aortic root measurements were also compared between C-arm CT and multidetector-row computed tomography (MDCT). The best C-arm CT image set was identified and used to predict optimal angiographic projection angles during TAVI; predictions were compared to those from MDCT. Methods 1, 3, 4, and 5 yielded sufficient root enhancement with mild or moderate artifacts and aortic annulus, sinotubular junction, and mid-ascending aorta diameters similar to MDCT. Ungated C-arm CT (Methods 1, 3) required less contrast than ECG-gated C-arm CT (Methods 4, 5). Method 3 was optimal yielding images with high attenuation, few artifacts (2.0), and root measurements similar to MDCT using minimal contrast (36 mL). Predicted angiographic projections from Method 3 were similar to MDCT. Ungated C-arm CT during rapid pacing with aortic root injection required minimal contrast, yielded high attenuation and few artifacts, and aortic root measurements and predicted angiographic planes similar to those from MDCT.

  11. Transcatheter double stent implantation for treatment of middle aortic coarctation syndrome.

    PubMed

    McMahon, Colin J; Lambert, Imelda; Walsh, Kevin P

    2013-10-01

    A 13-year-old boy presented with severe systemic hypertension. His upper limb blood pressure measured 190/100 mm Hg and lower limb blood pressure measured 98/64 mm Hg. The brachial pulses were bounding and femoral pulses were not palpable. Echocardiography and magnetic resonance angiography confirmed middle aortic syndrome. There was severe diffuse thoraco-abdominal coarctation with continuous Doppler run-off. Cardiac catheterization was undertaken and using a retrograde approach two Advanta V12 stents were implanted in the complex thoraco-abdominal coarctation. The gradient across the coarctation was reduced from 80 to 40 mm Hg gradient with a significant improvement in the luminal diameter of the aorta. His upper limb blood pressure reduced to 142/78 mm Hg six weeks later.

  12. Conscious Sedation versus General Anesthesia for Transcatheter Aortic Valve Replacement: Insights from the NCDR® STS/ACC TVT Registry.

    PubMed

    Hyman, Matthew C; Vemulapalli, Sreekanth; Szeto, Wilson Y; Stebbins, Amanda; Patel, Prakash A; Matsouaka, Roland A; Herrmann, Howard C; Anwaruddin, Saif; Kobayashi, Taisei; Desai, Nimesh D; Vallabhajosyula, Prashanth; McCarthy, Fenton H; Li, Robert; Bavaria, Joseph E; Giri, Jay

    2017-09-01

    Background -Conscious sedation is used during transcatheter aortic valve replacement (TAVR) with limited evidence as to the safety and efficacy of this practice. Methods -The NCDR STS/ACC TVT Registry was used to characterize the anesthesia choice and clinical outcomes of all U.S. patients undergoing elective percutaneous transfemoral TAVR between April 1, 2014 and June 30, 2015. Raw and inverse probability of treatment weighted (IPTW) analyses were performed to compare general anesthesia patients with conscious sedation patients on an intention-to-treat basis for the primary outcome of in-hospital mortality, and secondary outcomes including 30-day mortality, in-hospital and 30-day death/stroke, procedural success, ICU and hospital length-of-stay, and rates of discharge to home. Post-hoc falsification endpoint analyses were performed to evaluate for residual confounding. Results -Conscious sedation was used in 1,737/10,997 (15.8%) cases with a significant trend of increasing usage over the time period studied (p for trend <0.001). In raw analyses, intraprocedural success with conscious sedation and general anesthesia was similar (98.2% versus 98.5%, p=.31). The conscious sedation group was less likely to suffer in-hospital (1.6% vs. 2.5%, p=0.03) and 30-day death (2.9% vs. 4.1%, p = 0.03). Conversion from conscious sedation to general anesthesia was noted in 102/1737 (5.9%) of conscious sedation cases. After IPTW adjustment for 51 covariates, conscious sedation was associated with lower procedural success (97.9% vs. 98.6%, p<0.001) and a reduced rate of mortality at the in-hospital (1.5% vs. 2.4%, p<0.001) and 30-day (2.3% vs. 4.0%, p<0.001) timepoints. Conscious sedation was associated with reductions in procedural inotrope requirement, ICU and hospital length of stay (6.0 vs. 6.5 days, p < 0.001), and combined 30-day death/stroke rates (4.8% vs. 6.4%, p <0.001). Falsification endpoint analyses of vascular complications, bleeding, and new pacemaker

  13. Predictors and Association With Clinical Outcomes of the Changes in Exercise Capacity After Transcatheter Aortic Valve Replacement.

    PubMed

    Abdul-Jawad Altisent, Omar; Puri, Rishi; Regueiro, Ander; Chamandi, Chekrallah; Rodriguez-Gabella, Tania; Del Trigo, Maria; Campelo-Parada, Francisco; Couture, Thomas; Marsal, Josep Ramon; Côté, Mélanie; Paradis, Jean-Michel; DeLarochellière, Robert; Doyle, Daniel; Mohammadi, Siamak; Dumont, Eric; Rodés-Cabau, Josep

    2017-08-15

    At present, there are no objective data specifically examining the clinical impact of variations in exercise capacity post-transcatheter aortic valve replacement (TAVR). We describe the changes in exercise capacity between baseline and 6 months post-TAVR, and ascertain factors associated with and clinical implications of a lack of improvement in exercise capacity post-TAVR. A total of 305 patients (mean age, 79±9 years; 44% men; Society of Thoracic Surgeons predicted risk mortality score, 6.7±4.2%) undergoing TAVR completed both baseline and follow-up exercise capacity assessments at 6 months post-TAVR. Exercise capacity was evaluated by the 6-minute walk test (6MWT). Clinical outcomes were compared between patients displaying greater than (n=152; improving group) versus less than (n=153; nonimproving group) the median percentage change in distance walked between baseline and 6-month follow-up examinations. The primary outcome measure was clinical event rates, measured from the 6-month post-TAVR period onward. Further dichotomization according to baseline 6MWT distance (less than versus more than median walking distance, or slow walker versus fast walker) was also assessed. The mean overall distances walked pre- and post-TAVR (6 months post-TAVR) were 204±119 and 263±116 m, respectively (Δ6MWT=60±106 m), with 219 (72%) patients demonstrating an increase in their walking distance (median percentage increase of the entire population was 20% [interquartile range, 0%-80%]). Factors independently correlated with reduced exercise capacity improvement included a range of baseline clinical characteristics (older age, female sex, chronic obstructive pulmonary disease; P<0.05 for all), periprocedural major or life-threatening bleeding (P=0.009) and new-onset anemia at 6 months post-TAVR (P=0.009). Failure to improve the 6MWT distance by at least 20% was independently associated with all-cause mortality (P=0.002) and cardiovascular death or rehospitalization for

  14. Addition of albumin to Traditional Risk Score Improved Prediction of Mortality in Individuals Undergoing Transcatheter Aortic Valve Replacement.

    PubMed

    Grossman, Yoni; Barbash, Israel M; Fefer, Paul; Goldenberg, Ilan; Berkovitch, Anat; Regev, Ehud; Fink, Noam; Ben-Zekry, Sagit; Brodov, Yafim; Kogan, Alexander; Guetta, Victor; Raanani, Ehud; Segev, Amit

    2017-09-23

    The ability of the Society of Thoracic Surgeons (STS) and European System for Cardiac Operative Risk Evaluation (EuroSCORE)-2 scores to predict outcomes after transcatheter aortic valve replacement (TAVR) is insufficient. Frailty and serum albumin as a frailty marker were shown to correlate with prognosis after TAVR. We sought to evaluate the additive value of serum albumin to STS and EuroSCORE-2 scores to predict mortality in individuals undergoing TAVR. Retrospective analysis. Tertiary-care hospital prospective registry. Individuals who underwent TAVR (N = 426). We compared survival rates according to median baseline albumin levels (4 g/dL), STS score (4.5%), and EuroSCORE-2 (3.45%). Participants were divided into four groups according to median serum albumin and median STS and EuroSCORE-2 scores (high vs low), and 1-year survival rates were compared. A category-free net reclassification index (NRI) was calculated to compare the ability of a model of STS or EuroSCORE-2 alone to classify mortality risk with and without the addition of baseline serum albumin. Participants with low albumin levels had higher mortality (hazard ratio (HR) = 3.03, 95% confidence interval (CI) = 1.66-5.26, P < .001). Participants with low serum albumin and a high STS (HR = 4.55, 95% CI = 2.21-9.38, P < .001) or EuroSCORE-2 (HR = 2.72, 95% CI = 1.48-5.06, P = .001) score had higher mortality. Using NRI analysis, a model that included albumin in addition to STS correctly reclassified 42% of events (NRI = 0.58) and a model that included albumin in addition to EuroSCORE-2 correctly reclassified 44% of events (NRI = 0.64). Serum albumin, as a marker of frailty, can significantly improve the ability of STS and EuroSCORE-2 scores to predict TAVR-related mortality. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  15. Usefulness and validation of the survival posT TAVI score for survival after transcatheter aortic valve implantation for aortic stenosis.

    PubMed

    D'Ascenzo, Fabrizio; Capodanno, Davide; Tarantini, Giuseppe; Nijhoff, Freek; Ciuca, Cristina; Rossi, Marco Luciano; Brambilla, Nedy; Barbanti, Marco; Napodano, Massimo; Stella, Pieter; Saia, Francesco; Ferrante, Giuseppe; Tamburino, Corrado; Gasparetto, Valeria; Agostoni, Pierfrancesco; Marzocchi, Antonio; Presbitero, Patrizia; Bedogni, Francesco; Cerrato, Enrico; Omedè, Pierluigi; Conrotto, Federico; Salizzoni, Stefano; Biondi Zoccai, Giuseppe; Marra, Sebastiano; Rinaldi, Mauro; Gaita, Fiorenzo; D'Amico, Maurizio; Moretti, Claudio

    2014-12-15

    Surgical risk scores fail to accurately predict mortality after transcatheter aortic valve implantation (TAVI). The aim of this study was to develop and validate a dedicated risk score for accurate estimation of mortality risk in these patients. All consecutive patients who underwent TAVI at 6 international institutions were enrolled. Predictors for 1-year all-cause mortality were identified by means of Cox multivariate analysis and incorporated in a prediction score. Accuracy of the score was derived and externally validated for 30-day and 1-year mortality. The net classification improvement compared with the Society of Thoracic Surgeons (STS) score was appraised. A total of 1,064 patients constituted the derivation cohort and 180 patients constituted the external validation cohort. A total of 165 patients (15%) died at 1-year follow-up. Previous stroke (odds ratio [OR] 1.80, 1.4 to 3), inverse of renal clearance (OR 8, 6 to 14), and systolic pulmonary arterial pressure ≥50 mm Hg (OR 2.10, 1.5 to 3) were independently related to 1-year mortality. Area under the curve (AUC) of the survival post TAVI (STT) for 1-year mortality was 0.68 (0.62 to 0.71). At 30 days, 65 patients (7%) had died and the AUC for the STT at this time point was 0.66 (0.64 to 0.75). In the external validation cohorts, the AUC of the STT were 0.66 (0.56 to 0.7) for 30-day and 0.67 (0.62 to 0.71) for 1-year mortality. Net reclassification improvement for STT compared with STS was 31% (p <0.001) for 30-day mortality and 14% (p <0.001) for 1-year mortality. In conclusion, the STT score represents an easy and accurate tool to assess the risk of short-term and mid-term mortality in patients undergoing TAVI. Copyright © 2014 Elsevier Inc. All rights reserved.

  16. Predictors of permanent pacemaker requirement after transcatheter aortic valve implantation: insights from a Brazilian registry.

    PubMed

    Gensas, Caroline S; Caixeta, Adriano; Siqueira, Dimytri; Carvalho, Luiz A; Sarmento-Leite, Rogério; Mangione, José A; Lemos, Pedro A; Colafranceschi, Alexandre S; Caramori, Paulo; Ferreira, Maria Cristina; Abizaid, Alexandre; Brito, Fábio S

    2014-08-01

    The aim of this study is to evaluate the predictors of permanent pacemaker (PPM) implantation after TAVI. Between January 2008 and February 2012, 418 patients with severe aortic stenosis underwent TAVI and were enrolled in a Brazilian multicenter registry. After excluding patients who died during the procedure and those with a previous PPM, 353 patients were included in the analysis. At 30 days, the overall incidence of PPM implantation was 25.2%. Patients requiring PPM were more likely to be older (82.73 vs. 81.10 years, p=0.07), have pre-dilation (68.42% vs. 60.07%, p=0.15), receive CoreValve (93.68% vs. 82.55%, p=0.008), and have baseline right bundle branch block (RBBB, 25.26% vs. 6.58%, p<0.001). On multivariable analysis, CoreValve vs. Sapien XT (OR, 4.24; 95% CI, 1.56-11.49; p=0.005), baseline RBBB (OR, 4.41; 95% CI, 2.20-8.82; p<0.001), and balloon pre-dilatation (OR, 1.75; 95% CI, 1.02-3.02; p=0.04) were independent predictors of PPM implantation. PPM implantation occurred in approximately one-fourth of cases. Pre-existing RBBB, balloon pre-dilatation, and CoreValve use were independent predictors of PPM after TAVI. The type of prosthesis used and pre-balloon dilatation should be considered in TAVI candidates with baseline RBBB. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  17. Predictors of Paravalvular Regurgitation After Implantation of the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Valve (from the REPRISE II Trial Extended Cohort).

    PubMed

    Blackman, Daniel J; Meredith, Ian T; Dumonteil, Nicolas; Tchétché, Didier; Hildick-Smith, David; Spence, Mark S; Walters, Darren L; Harnek, Jan; Worthley, Stephen G; Rioufol, Gilles; Lefèvre, Thierry; Houle, Vicki M; Allocco, Dominic J; Dawkins, Keith D

    2017-07-15

    Paravalvular leak (PVL) after transcatheter aortic valve replacement is associated with worse long-term outcomes. The Lotus Valve incorporates an innovative Adaptive Seal designed to minimize PVL. This analysis evaluated the incidence and predictors of PVL after implantation of the Lotus transcatheter aortic valve. The REPRISE II (REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Evaluation of Safety and Performance) Study With Extended Cohort enrolled 250 high-surgical risk patients with severe symptomatic aortic stenosis. Aortic regurgitation was assessed by echocardiography pre-procedure, at discharge and 30 days, by an independent core laboratory. Baseline and procedural predictors of mild or greater PVL at 30 days (or at discharge if 30-day data were not available) were determined using a multivariate regression model (n = 229). Of the 229 patients, 197 (86%) had no/trace PVL, 30 had mild, and 2 had moderate PVL; no patient had severe PVL. Significant predictors of mild/moderate PVL included device:annulus area ratio (odds ratio [OR] 0.87; 95% CI 0.83 to 0.92; p <0.001), left ventricular outflow tract calcium volume (OR 2.85; 95% CI 1.44 to 5.63; p = 0.003), and annulus area (OR 0.89; 95% CI 0.82 to 0.96; p = 0.002). When the device:annulus area ratio was <1, the rate of mild/moderate PVL was 53.1% (17 of 32). The rates of mild/moderate PVL with 0% to 5%, 5% to 10%, and >10% annular oversizing by area were 17.5% (11 of 63), 2.9% (2 of 70), and 3.2% (2 of 63), respectively. Significant independent predictors of PVL included device:annulus area ratio and left ventricular outflow tract calcium volume. When the prosthetic valve was oversized by ≥5%, the rate of mild or greater PVL was only 3%. In conclusion, the overall rates of PVL with the Lotus Valve are low and predominantly related to device/annulus areas and calcium; these findings have implications for optimal device sizing. Copyright

  18. 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

  19. Four-year clinical results of transcatheter self-expanding Medtronic CoreValve implantation in high-risk patients with severe aortic stenosis.

    PubMed

    Thomopoulou, Sofia; Vavuranakis, Manolis; Karyofyllis, Panagiotis; Kariori, Maria; Karavolias, George; Balanika, Marina; Smyrli, Anna; Stefopoulos, Christos; Sbarouni, Eftihia; Moldovan, Carmen; Khoury, Mazen; Stefanadis, Christodoulos; Voudris, Vassilis

    2016-05-01

    transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement for patients with severe aortic stenosis considered inoperable or at high operative risk, but the long-term outcome remains unknown. we assessed the 4-year clinical and echocardiographic outcomes of patients undergoing TAVI with the self-expanding Medtronic CoreValve prosthesis. sixty-three patients (mean age 80 ± 6 years) with severe aortic stenosis (AS) at high risk for surgical aortic valve replacement (Logistic EuroSCORE 28.8 ± 10.9%) were included in this study. all-cause cumulative mortality at 1, 2, 3 and 4 years was 14.3, 25.4, 28.6 and 36.5%, respectively. The cumulative incidence of documented major stroke at 4 years was 6.3%. In survivors, there was a significant improvement in functional status at 4 years. Paravalvular leak (trivial/mild to moderate) was observed in the majority of patients post-TAVI with no case of progression to severe regurgitation at 4-year follow-up. In multivariate analysis, independent predictor for increased all-cause mortality was left ventricular ejection fraction <40% (HR: 5.347, 95% CI: 1.126-25.381, P = 0.035). our study demonstrated favourable long-term (4 years) outcomes after successful TAVI using the third-generation Medtronic CoreValve device. © The Author 2016. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  20. Effect of body mass index on the image quality of rotational angiography without rapid pacing for planning of transcatheter aortic valve implantation: a comparison with multislice computed tomography.

    PubMed

    Schultz, Carl J; van Mieghem, Nicholas M; van der Boon, Robert M; Dharampal, Anoeshka S; Lauritsch, Guenter; Rossi, Alexia; Moelker, Adriaan; Krestin, Gabriel; van Geuns, Robert; de Feijter, Pim; Serruys, Patrick W; de Jaegere, Peter

    2014-02-01

    To evaluate the feasibility of procedural planning for transcatheter aortic valve implantation (TAVI) using rotational angiography (R-angio) by comparison with multislice computed tomography (MSCT) and to investigate determinants of the image quality of R-angio. Patients who underwent R-angio of the left ventricle and cardiac MSCT were eligible. R-angio acquisition was performed during contrast injection through a 6F pigtail catheter positioned in the left ventricle. On 3D R-angio and MSCT data sets, diameter measurements were made on short-axis images at the level of the aortic annulus (D(perimeter), D(area)), ascending aorta, sino-tubular junction (ST-junction), and the sinus of Valsalva. At the level of the aortic annulus, diagnostic image quality was obtained in 49 of 56 patients. In all patients with a body mass index (BMI) < 29 kg/m(2), image quality was acceptable whether or not rapid pacing was used. In patients with BMI ≥ 29 kg/m(2), the image quality was poor in 1 of 9 (11%) who were rapidly paced compared with 6 of 12 (50%) who were not. The correlation between R-angio and MSCT measurements was high for aortic annulus D(perimeter), D(area), ST-junction, Valsalva sinus, and ascending aorta (respectively, R = 0.90, 0.90, 0.91, 0.92, and 0.89). The correlations improved further when the analysis was limited to patients with a BMI < 29 kg/m(2) (respectively, 0.92, 0.92, 0.92, 0.92, and 0.93). R-angio of the left ventricle allows precise measurement of the aortic root and annulus and was feasible for sizing at the time of TAVI. Diagnostic image quality was obtained without rapid pacing in all patients with a BMI < 29 kg/m(2).

  1. 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

  2. Thoracic Malignancies and Pulmonary Nodules in Patients under Evaluation for Transcatheter Aortic Valve Implantation (TAVI): Incidence, Follow Up and Possible Impact on Treatment Decision

    PubMed Central

    Kaleschke, Gerrit; Schülke, Christoph; Görlich, Dennis; Schliemann, Christoph; Kessler, Torsten; Schulze, Arik Bernard; Buerke, Boris; Kuemmel, Andreas; Thrull, Michael; Wiewrodt, Rainer; Baumgartner, Helmut; Berdel, Wolfgang E.; Mohr, Michael

    2016-01-01

    Background Transcatheter aortic valve implantation (TAVI) has become the treatment of choice in patients with severe aortic valve stenosis who are not eligible for operative replacement and an alternative for those with high surgical risk. Due to high age and smoking history in a high proportion of TAVI patients, suspicious findings are frequently observed in pre-procedural chest computer tomography (CCT). Methods CCT scans of 484 consecutive patients undergoing TAVI were evaluated for incidentally discovered solitary pulmonary nodules (SPN). Results In the entire study population, SPN ≥ 5 mm were found in 87 patients (18%). These patients were compared to 150 patients who were incidentally collected from the 397 patients without SPN or with SPN < 5 mm (control group). After a median follow-up of 455 days, lung cancer was diagnosed in only two patients. Neither SPN ≥ 5 mm (p = 0.579) nor SPN > 8 mm (p = 0.328) were significant predictors of overall survival. Conclusions Despite the high prevalence of SPNs in this single center TAVI cohort lung cancer incidence at midterm follow-up seems to be low. Thus, aggressive diagnostic approaches for incidentally discovered SPN during TAVI evaluation should not delay the treatment of aortic stenosis. Unless advanced thoracic malignancy is obvious, the well documented reduction of morbidity and mortality by TAVI outweighs potentially harmful delays regarding further diagnostics. Standard guideline-approved procedure for SPN can be safely performed after TAVI. PMID:27171441

  3. 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

  4. 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.

  5. Association of Patient-Reported Health Status With Long-Term Mortality After Transcatheter Aortic Valve Replacement: Report From the STS/ACC TVT Registry.

    PubMed

    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

    2015-12-01

    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 2 clinically relevant factors (symptoms and functional status) that may predict TAVR outcomes. Among 7769 patients from 286 sites in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry, we examined the association between preprocedure (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 to 49, fair: 50 to 74, or good: ≥75. Before 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 women and had more comorbidities and higher STS mortality risk scores. Compared with those with good health status before 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 hazard ratio, 2.00; 95% confidence interval, 1.58-2.54), whereas those with poor and fair health status had intermediate outcomes (adjusted hazard ratio, 1.54; 95% confidence interval, 1.22-1.95 and adjusted hazard ratio, 1.20; 95% confidence interval, 0.94-1.55, respectively). In a national, contemporary practice cohort, worse preprocedure 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. © 2015 American Heart Association, Inc.

  6. Different impact of aortic regurgitation assessed by aortic root angiography after transcatheter aortic valve implantation according to baseline left ventricular ejection fraction and N-terminal pro-B-type natriuretic peptide.

    PubMed

    Kaneko, Hidehiro; Hoelschermann, Frank; Schau, Thomas; Tambor, Grit; Neuss, Michael; Butter, Christian

    2017-05-31

    Transcatheter aortic valve implantation (TAVI) is an alternative therapeutic option for severe aortic stenosis. Aortic regurgitation (AR) is commonly observed after TAVI and increases the mortality rate. We hypothesized that the influence of significant AR, defined as that more severe than mild AR, on survival rate after TAVI might differ according to the baseline left ventricular ejection fraction (LVEF) and N-terminal pro-B-type natriuretic peptide (NT-pro BNP) level. We categorized 856 patients who underwent transfemoral TAVI into 2 groups according to their baseline LVEF (<40 and ≥40%) and NT-pro BNP levels (≤5000 and >5000 pg/mL). Significant AR was observed in 92 patients (11%). Among patients with significant AR, the proportion of patients with CoreValve/EvolutR implantation was higher than that of patients with SAPIEN XT/3 implantation. Kaplan-Meier curves and the log-rank test showed that significant AR was not associated with 1-year mortality in patients with LVEF ≥40% and those with NT-pro BNP level ≤5000 pg/mL. On the other hand, it was significantly associated with a higher 1-year mortality in patients with LVEF <40% (p = 0.003) and those with NT-pro BNP level >5000 pg/mL (p = 0.011). Similarly, multivariate Cox regression analysis showed that the presence of AR was significantly associated with a higher 1-year mortality in patients with LVEF <40% [p = 0.005, hazard ratio (HR) = 3.626] and NT-pro BNP level >5000 pg/mL (p = 0.004, HR = 3.221). However, AR was not significantly associated with a higher 1-year mortality in patients with LVEF ≥40% and NT-pro BNP level ≤5000 pg/mL. Thus, the impact of significant AR on mortality after TAVI seems to be considerable in patients with reduced LVEF or high NT-pro BNP levels, but not those with preserved LVEF or low NT-pro BNP levels, suggesting that the influence of AR differs depending on the baseline LVEF and NT-pro BNP level.

  7. Multislice computed tomography-based prediction of the implantation plane in transcatheter aortic valve implantation: determination of the line of perpendicularity and the implanter's views.

    PubMed

    Holzamer, Andreas; Sitka, Emanuel; Hengstenberg, Christian; Schmid, Christof; Debl, Kurt; Maier, Lars; Camboni, Daniele; Husser, Oliver; Hilker, Michael

    2015-12-01

    We demonstrate a multislice computed tomography (MSCT)-based method to calculate the prediction of the so-called 'line of perpendicularity' (LOP) and the 'implanter's views' (IVs) for transcatheter aortic valve implantation (TAVI) procedures. The LOP represents all possible angiographic angulations that result in an orthogonal view to the aortic annulus plane. The IVs allow visual confirmation of correct implantation planes, and are crucial for the commissural aligned implantation of second-generation TAVI prostheses. The LOP and IVs of 335 concomitant patients were prospectively analysed using multiple plane reconstruction (MPR) of the patient's MSCT scans. Exclusion criteria were bicuspid valves (n = 18) and valve-in-valve TAVI (n = 15). In the MPRs, the aortic cusps' lowest points were marked. With the marker's three-dimensional coordinates, the graph of the LOP with the IVs was calculated and plotted using vector mathematics. In the last 244 cases, the IV with the right coronary cusp in front was chosen for the first aortic root angiogram of the TAVI procedure. The finally used angulation was confirmed by aortic angiogram prior to the valve implantation. Solid angle differences that show the combined left anterior oblique/right anterior oblique and cranio/caudal movement of the C-arm allow quantification of corrections as well as demonstrate interindividual variations. There is a broad interindividual variation of the aortic valve's topology with solid angle variations of up to 74°. The shape of the LOPs is extremely varying, especially regarding the slope of the curve that indicates differences in valve orientations. Among the 244 patients for whom we used the prediction for the procedure, the first angiogram was considered perfect for implantation without further corrections in 97% (n = 237) of them. In case of the 7 patients with subsequent corrections, the mean solid angle between the prediction and the final angiogram prior to implantation was 6.2° (±5

  8. Comparison of Edwards SAPIEN 3 versus SAPIEN XT in transfemoral transcatheter aortic valve implantation: Difference of valve selection in the real world.

    PubMed

    Arai, Takahide; Lefèvre, Thierry; Hovasse, Thomas; Morice, Marie-Claude; Garot, Philippe; Benamer, Hakim; Unterseeh, Thierry; Hayashida, Kentaro; Watanabe, Yusuke; Bouvier, Erik; Cormier, Bertrand; Chevalier, Bernard

    2017-03-01

    The SAPIEN 3 (S3; Edwards Lifescience, Irvine, CA, USA) is a new-generation percutaneous aortic valve with better profile, more precise handling and positioning, designed to reduce the risk of post-procedural paravalvular aortic leak (PVL). The aim of this study was to compare the S3 valve and SAPIEN XT valve (SXT). The last 89 transfemoral transcatheter aortic valve implantation (TAVI) cases using SXT were compared to the first 111 cases using the S3. Patient age and logistic EuroSCORE were similar (83.1 years vs 83.0 years and 18.2% vs 16.6%) in the S3 and SXT groups, respectively as were other baseline characteristics. The ratio of valve diameter/calculated annulus average diameter (CAAD) by multi-detector row computed tomography was significantly lower in the S3 group (1.06 vs 1.09, p<0.001) as was the annular area oversizing percentage (11.3% vs 20.5%, p<0.001). Furthermore, a smaller valve was selected in S3 cases with borderline CAAD compared to SXT cases. Nevertheless, the frequency of paravalvular aortic leakage (PVL) ≥2 tended to be reduced in the S3 group (5% vs 9%, p=0.339). The rate of major vascular complications was significantly lower with S3 (3% vs 12%, p=0.013). In addition, 30-day mortality was significantly lower in the S3 group (0% vs 5%, p=0.044). Although TAVI using S3 tended to be carried out with a less oversized valve compared to TAVI using SXT, the frequency of post-procedural PVL ≥2 tended to be lower in the S3 group. The outcomes including vascular complications and 30-day mortality showed a trend in favor of the S3 group. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  9. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial.

    PubMed

    Miller, D Craig; Blackstone, Eugene H; Mack, Michael J; Svensson, Lars G; Kodali, Susheel K; Kapadia, Samir; Rajeswaran, Jeevanantham; Anderson, William N; Moses, Jeffrey W; Tuzcu, E Murat; Webb, John G; Leon, Martin B; Smith, Craig R

    2012-04-01

    All neurologic events in the PARTNER randomized trial comparing transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (AVR) were analyzed. High-risk patients with aortic stenosis were stratified into transfemoral (TF, n = 461) or transapical (TA, n = 196) strata based on their arterial anatomy and randomized: 657 received treatment assigned ("as treated"), 313 underwent AVR, and 344 TAVR. Neurologic events were prospectively adjudicated by an independent Clinical Events Committee. Multivariable, multiphase hazard analysis elucidated factors associated with increased likelihood of neurologic events. Forty-nine neurologic events (15 transient ischemic attacks, 34 strokes) occurred in 47 patients (TAVR, n = 31; AVR, n = 16). An early peaking high hazard phase occurred within the first week, which declined to a constant late hazard phase out to 2 years. The risk in the early phase was higher after TAVR than AVR, and in the TAVR arm in patients with a smaller aortic valve area index. In the late risk phase, the likelihood of neurologic event was linked to patient-related factors in both arms ("non-TF candidate," history of recent stroke or transient ischemic attack, and advanced functional disability), but not by treatment (TAVR vs AVR) or any intraprocedural variables. The likelihood of sustaining a neurologic event was lowest in the AVR subgroup in the TF stratum during all available follow-up. After either treatment, there were 2 distinct hazard phases for neurologic events that were driven by different risk factors. Neurologic complications occurred more frequently after TAVR than AVR early, but thereafter the risk was influenced by patient- and disease-related factors. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  10. Contrast volume reduction using third generation dual source computed tomography for the evaluation of patients prior to transcatheter aortic valve implantation.

    PubMed

    Bittner, Daniel O; Arnold, Martin; Klinghammer, Lutz; Schuhbaeck, Annika; Hell, Michaela M; Muschiol, Gerd; Gauss, Soeren; Lell, Michael; Uder, Michael; Hoffmann, Udo; Achenbach, Stephan; Marwan, Mohamed

    2016-12-01

    Chronic renal failure is common in patients referred for transcatheter aortic valve implantation (TAVI). CT angiography is recommended and provides crucial information prior to TAVI. We evaluated the feasibility of a reduced contrast volume protocol for pre-procedural CT imaging. Forty consecutive patients were examined with prospectively ECG-triggered high-pitch spiral acquisition using a novel third-generation dual-source CT system; 38 ml contrast agent was used. Image quality was graded on a visual scale (1-4). Contrast attenuation was measured at the level of the aortic root and at the iliac bifurcation. Mean patient age was 82 ± 6 years (23 males; 58 %). Mean attenuation/average image quality was 285 ± 60 HU/1.5 at the aortic annulus compared to 289 ± 74 HU/1.8 at the iliac bifurcation (p = 0.77/p = 0.29). Mean estimated effective radiation dose was 2.9 ± 0.3 mSv. A repeat acquisition was necessary in one patient due to image quality. Out of the 35 patients who underwent TAVI, 31 (89 %) patients had no or mild aortic regurgitation. Thirty-two (91 %) patients were discharged successfully. Pre-procedural CTA with a total of 38 ml contrast volume is feasible and clinically useful, using third-generation dual-source CT, allowing comprehensive imaging for procedural success. • Reduction of contrast agent volume is crucial in patients with chronic renal failure. • Novel third-generation computed tomography helps to reduce contrast agent volume. • Pre-procedural CT allows comprehensive imaging for procedural success before heart valve implantation. • A low-contrast CT protocol is feasible for pre-procedural TAVI planning.

  11. Prognostic value of the ratio between prosthesis area and indexed annulus area measured by MultiSlice-CT for transcatheter aortic valve implantation procedures

    PubMed Central

    Debry, Nicolas; Sudre, Arnaud; Elquodeimat, Ibrahim; Delhaye, Cédric; Schurtz, Guillaume; Bical, Antoine; Koussa, Mohamad; Fattouch, Khalil; Modine, Thomas

    2016-01-01

    Background Postprocedural aortic regurgitations following transcatheter aortic valve implantation (TAVI) procedures remain an issue. Benefit of oversizing strategies to prevent them isn't well established. We compared different level of oversizing in our cohort of consecutive patients to address if severe oversizing compared to normal sizing had an impact on post-procedural outcomes. Methods From January 2010 to August 2013, consecutive patients were referred for TAVI with preoperative Multislice-CT (MSCT) and the procedures were achieved using Edwards Sapien® or Corevalve devices®. Retrospectively, according to pre-procedural MSCT and the valve size, patients were classified into three groups: normal, moderate and severe oversizing; depending on the ratio between the prosthesis area and the annulus area indexed and measured on MSCT. Main endpoint was mid-term mortality and secondary endpoints were the Valve Academic Research Consortium (VARC-2) endpoints. Results Two hundred and sixty eight patients had a MSCT and underwent TAVI procedure, with mainly Corevalve®. While all-cause and cardiovascular mortality rates were similar in all groups, post-procedural new pacemaker (PM) implantation rate was significantly higher in the severe oversizing group (P = 0.03), while we observed more in-hospital congestive heart-failure (P = 0.02) in the normal sizing group. There was a trend toward more moderate to severe aortic regurgitation (AR) in the normal sizing group (P = 0.07). Conclusions Despite a higher rate of PM implantation, oversizing based on this ratio reduces aortic leak with lower rates of post-procedural complications and a similar mid-term survival. PMID:27582762

  12. 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.

  13. Aortic Root Rupture during Transcatheter Aortic Valve Implantation in a Patient with Idiopathic Thrombocytopenic Purpura: Utility of Transesophageal Echocardiography in Early Detection and Description of a Semiconservative Surgical Management Approach.

    PubMed

    Chandrasekhar, Jaya; Ruel, Marc; Nicholson, Donna; Labinaz, Marino

    2016-12-01

    An 87-year-old man with idiopathic thrombocytopenic purpura and platelet count of 56 × 10(9)/L underwent transesophageal echocardiography (TEE)-guided transcatheter aortic valve implantation using a femoral approach. Post valve deployment, a new pericardial effusion was noted which was successfully drained. Despite this, the patient became hypotensive needing vasopressor support with reaccumulation of pericardial fluid. Emergent sternotomy was performed and a perforation of the right ventricular apex was noted which was sealed with a pledgeted suture. Continued bleeding prompted further exploration; the aorta was seen to be mottled in conjunction with clear aortic root hematoma on TEE and a diagnosis of root rupture was made. This was semiconservatively managed without conversion to a full aortic root repair or replacement procedure. Multiple sutures were applied to the periaortic space and the bleeding sealed with use of BioGlue (Cryolife Inc., Kennesaw, GA) and Surgicel (Ethicon Inc., Somerville, NJ). The postoperative course was stable and the patient remained well at 3-month follow-up.

  14. 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.

  15. Mechanisms of Heart Block after Transcatheter Aortic Valve Replacement – Cardiac Anatomy, Clinical Predictors and Mechanical Factors that Contribute to Permanent Pacemaker Implantation

    PubMed Central

    Young Lee, Mark; Chilakamarri Yeshwant, Srinath; Chava, Sreedivya; Lawrence Lustgarten, Daniel

    2015-01-01

    Transcatheter aortic valve replacement (TAVR) has emerged as a valuable, minimally invasive treatment option in patients with symptomatic severe aortic stenosis at prohibitive or increased risk for conventional surgical replacement. Consequently, patients undergoing TAVR are prone to peri-procedural complications including cardiac conduction disturbances, which is the focus of this review. Atrioventricular conduction disturbances and arrhythmias before, during or after TAVR remain a matter of concern for this high-risk group of patients, as they have important consequences on hospital duration, short- and long-term medical management and finally on decisions of device-based treatment strategies (pacemaker or defibrillator implantation). We discuss the mechanisms of atrioventricular disturbances and characterise predisposing factors. Using validated clinical predictors, we discuss strategies to minimise the likelihood of creating permanent high-grade heart block, and identify factors to expedite the decision to implant a permanent pacemaker when the latter is unavoidable. We also discuss optimal pacing strategies to mitigate the possibility of pacing-induced cardiomyopathy. PMID:26835105

  16. Impact of optimising fluoroscopic implant angles on paravalvular regurgitation in transcatheter aortic valve replacements - utility of three-dimensional rotational angiography.

    PubMed

    Poon, Karl K; Crowhurst, James; James, Christopher; Campbell, Douglas; Roper, Damian; Chan, Jonathan; Incani, Alexander; Clarke, Andrew; Tesar, Peter; Aroney, Constantine; Raffel, Owen Christopher; Walters, Darren L

    2012-09-01

    The clinical value of optimising implant angles during transcatheter aortic valve replacements (TAVR) remains undefined. The Aortic Valve Guide (AVG) is a proprietary software that provides structured analysis of three-dimensional images from rotational angiography (DynaCT). This study compares AVG with preprocedural multislice computed tomography (MSCT) and DynaCT in optimal implant angle prediction for TAVR, and evaluates if an optimised implant angle is associated with reduced paravalvular regurgitation (PVR). One hundred and six consecutive patients were included, comprising three groups. Group 1 (n=19) underwent no preprocedural MSCT or DynaCT (or AVG); Group 2 (n=44) underwent periprocedural DynaCT, without AVG; Group 3 (n=43) had DynaCT with AVG. Implant angles yielded were graded as excellent, satisfactory or poor. Group 3 were more likely than Groups 2 and 1 to have excellent implant angles (83.7% vs. 52.3% vs. 42.1%, respectively, p=0.001). In 100 patients who had 30-day transthoracic echocardiogram follow-up, an excellent implant angle was significantly more likely to be associated with no PVR than a non-excellent angle (41.3% vs. 21.6%, respectively, p=0.045), independent of operator experience and THV used. Optimising implant angles may be important in reducing PVR. This is significantly more likely to be achieved with AVG rotational angiography.

  17. 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

  18. First-in-man transcatheter mitral valve-in-ring implantation with a repositionable and retrievable aortic valve prosthesis.

    PubMed

    Latib, Azeem; Ruparelia, Neil; Bijuklic, Klaudija; De Marco, Federico; Gatto, Fernando; Hansen, Lorenz; Ozbek, Cem; Greilach, Peter; Bruschi, Giuseppe; Rieß, Friedrich-Christian; Alfieri, Ottavio; Colombo, Antonio; Schofer, Joachim

    2016-02-01

    Transcatheter interventions with balloon-expandable valves have been shown to be efficacious for the treatment of mitral annuloplasty failure but are limited by the fact that there is no opportunity for post-implantation adjustment. The aim of this study was to assess the safety and efficacy of the fully repositionable and retrievable Direct Flow Medical (DFM) valve for the treatment of mitral annuloplasty failure. Patients who underwent transcatheter mitral valve-in-ring (VIR) implantation of a DFM valve for failed mitral annuloplasty deemed high risk for redo surgery were included at four institutions. Eight patients underwent transcatheter mitral VIR procedures with implantation of the DFM valve. The DFM prosthesis was successfully positioned in all patients. Two patients required retrieval of the device due to a suboptimal result, and a further patient required repositioning of the valve with an ultimately successful implantation. During the 30-day follow-up period, two patients died for reasons unrelated to the valve implantation. The four patients with successful implantation had normal valve function associated with a significant improvement in their functional status. For the first time, we demonstrate the safety, efficacy and advantages of using the DFM prosthesis for the treatment of mitral annuloplasty failure.

  19. [New conduction disturbances and pacemaker indications after CoreValve® transcatheter aortic valve replacement. Incidence and follow up in a single center experience].

    PubMed

    Aversa, Eliana; Muratore, Claudio A; Nemesio, M Laura; Tentori, Maria Cristina; Payaslian, Miguel

    2015-01-01

    Transcatheter aortic valve implantation (TAVI) is currently reserved for patients with symptomatic aortic stenosis and high surgical risk. One major limiting factor related to TAVI procedural complications is conduction abnormalities and the need for permanent pacemaker implantation. Evaluate the incidence of new conduction disturbances and pacemaker indications in patients with TAVI CoreValve® prosthesis (Medtronic Inc. Minneapolis, Minnesota, United States). We included 28 patients, mean age 80 years. ECG parameters were evaluated previous and after implantation. All patients were monitorized during TAVI. Follow up Holter monitoring was performed at one, 6 and 12 months after the procedure and we also evaluated telemetry of implanted pacemaker. In previous ECG we found 7 patients had right bundle branch block and 7 patients had left bundle brunch block (LBBB). The post implant ECG showed 7 new LBBB: 3 during valvuloplasty and 4 on the end of it. Six patients required pacemaker implantation for permanent or paroxysmal complete AV block (CAVB). At one year follow up, 3 patients with LBBB during valvuloplasty had a normal ECG, one still had LBBB and one an asymptomatic CAVB found in Holter monitoring. Conduction abnormalities are frequent after CoreValve® aortic valve prosthesis implantation. The incidence of new LBBB was 25%. CAVB during or post TAVI require PM implantation. New LBBB may need a closer follow up because in a 3% of the cases it may progress to CAVB. Copyright © 2014 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

  20. Comparison of Manual and Automated Preprocedural Segmentation Tools to Predict the Annulus Plane Angulation and C-Arm Positioning for Transcatheter Aortic Valve Replacement

    PubMed Central

    Kleinebrecht, Laura; Balzer, Jan; Hellhammer, Katharina; Polzin, Amin; Horn, Patrick; Blehm, Alexander; Minol, Jan-Philipp; Kröpil, Patric; Westenfeld, Ralf; Rassaf, Tienush; Lichtenberg, Artur; Kelm, Malte

    2016-01-01

    Background Preprocedural manual multi-slice-CT-segmentation tools (MSCT-ST) define the gold standard for planning transcatheter aortic valve replacement (TAVR). They are able to predict the perpendicular line of the aortic annulus (PPL) and to indicate the corresponding C-arm angulation (CAA). Fully automated planning-tools and their clinical relevance have not been systematically evaluated in a real world setting so far. Methods and Results The study population consists of an all-comers cohort of 160 consecutive TAVR patients with a drop out of 35 patients for technical and anatomical reasons. 125 TAVR patients underwent preprocedural analysis by manual (M-MSCT) and fully automated MSCT-ST (A-MSCT). Method-comparison was performed for 105 patients (Cohort A). In Cohort A, CAA was defined for each patient, and accordance within 10° between M-MSCT and A-MSCT was considered adequate for concept-proof (95% in LAO/RAO; 94% in CRAN/CAUD). Intraprocedural CAA was defined by repetitive angiograms without utilizing the preprocedural measurements. In Cohort B, intraprocedural CAA was established with the use of A-MSCT (20 patients). Using preprocedural A-MSCT to indicate the corresponding CAA, the levels of contrast medium (ml) and radiation exposure (cine runs) were reduced in Cohort B compared to Cohort A significantly (23.3±10.3 vs. 35.3 ±21.1 ml, p = 0.02; 1.6±0.7 vs. 2.4±1.4 cine runs; p = 0.02) and trends towards more safety in valve-positioning could be demonstrated. Conclusions A-MSCT-analysis provides precise preprocedural information on CAA for optimal visualization of the aortic annulus compared to the M-MSCT gold standard. Intraprocedural application of this information during TAVR significantly reduces the levels of contrast and radiation exposure. Trial Registration ClinicalTrials.gov NCT01805739 PMID:27073910

  1. The importance of contrast volume/glomerular filtration rate ratio in contrast-induced nephropathy patients after transcatheter aortic valve implantation.

    PubMed

    Gul, Ilker; Zungur, Mustafa; Tastan, Ahmet; Okur, Faik Fevzi; Damar, Ertan; Uyar, Samet; Sahin, Veysel; Tavli, Talat

    2015-02-01

    Transcatheter aortic valve implantation (TAVI) is a method which is increasingly applied in severe aortic stenosis treatment. The development of contrast-induced nephropathy (CIN) after TAVI increases morbidity and mortality rates. Within the scope of this study, the importance of the contrast medium volume to glomerular filtration rate (CV/GFR) ratio in determining the development of CIN and the amount of CV that could be applied was evaluated. Seventy-two patients (aged 78.6 ± 11.6 years; 38 females) who underwent aortic valve replacement with the TAVI method between June 2013 and August 2014 were included in the study. CIN was defined as an absolute increase in serum creatinine of >0.5 mg/dl or a relative increase of >25% within 48-72 h after TAVI. CIN+ and CIN-patients were classified into two groups. The χ(2) test, t test, Mann-Whitney U test, ROC analysis, and univariate and multivariate regression analyses were applied for statistical analyses. CIN was detected in 16 patients (22%) in our study. Baseline creatinine, baseline GFR, the Mehran risk score, CV, and the CV/GFR ratio were determined as the predictive factors of CIN development. A CV/GFR ratio of 3.9 was specified to predict CIN development with 71% sensitivity and 80% specificity. After TAVI, CIN may develop due to various reasons. In patients to whom TAVI was applied, the CV/GFR ratio may be a guideline helping to prevent the development of renal pathologies. The amount of contrast medium that can be given to a patient can be calculated in terms of baseline GFR.

  2. The Importance of Contrast Volume/Glomerular Filtration Rate Ratio in Contrast-Induced Nephropathy Patients after Transcatheter Aortic Valve Implantation

    PubMed Central

    Gul, Ilker; Zungur, Mustafa; Tastan, Ahmet; Okur, Faik Fevzi; Damar, Ertan; Uyar, Samet; Sahin, Veysel; Tavli, Talat

    2015-01-01

    Background/Aim Transcatheter aortic valve implantation (TAVI) is a method which is increasingly applied in severe aortic stenosis treatment. The development of contrast-induced nephropathy (CIN) after TAVI increases morbidity and mortality rates. Within the scope of this study, the importance of the contrast medium volume to glomerular filtration rate (CV/GFR) ratio in determining the development of CIN and the amount of CV that could be applied was evaluated. Methods Seventy-two patients (aged 78.6 ± 11.6 years; 38 females) who underwent aortic valve replacement with the TAVI method between June 2013 and August 2014 were included in the study. CIN was defined as an absolute increase in serum creatinine of >0.5 mg/dl or a relative increase of >25% within 48-72 h after TAVI. CIN+ and CIN-patients were classified into two groups. The χ2 test, t test, Mann-Whitney U test, ROC analysis, and univariate and multivariate regression analyses were applied for statistical analyses. Results CIN was detected in 16 patients (22%) in our study. Baseline creatinine, baseline GFR, the Mehran risk score, CV, and the CV/GFR ratio were determined as the predictive factors of CIN development. A CV/GFR ratio of 3.9 was specified to predict CIN development with 71% sensitivity and 80% specificity. Conclusion After TAVI, CIN may develop due to various reasons. In patients to whom TAVI was applied, the CV/GFR ratio may be a guideline helping to prevent the development of renal pathologies. The amount of contrast medium that can be given to a patient can be calculated in terms of baseline GFR. PMID:25759698

  3. 1-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results of the REPRISE II Study.

    PubMed

    Meredith, Ian T; Walters, Darren L; Dumonteil, Nicolas; Worthley, Stephen G; Tchétché, Didier; Manoharan, Ganesh; Blackman, Daniel J; Rioufol, Gilles; Hildick-Smith, David; Whitbourn, Robert J; Lefèvre, Thierry; Lange, Rüdiger; Müller, Ralf; Redwood, Simon; Feldman, Ted E; Allocco, Dominic J; Dawkins, Keith D

    2016-02-22

    This analysis presents the first report of 1-year outcomes of the 120 patients enrolled in the REPRISE II (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance) study. The fully repositionable and retrievable Lotus Valve (Boston Scientific, Marlborough, Massachusetts) was designed to facilitate accurate positioning, early valve function, and hemodynamic stability during deployment and to minimize paravalvular regurgitation in patients undergoing transcatheter aortic valve replacement. The study enrolled 120 symptomatic patients 70 years of age or older at 14 centers in Australia and Europe. Patients had severe calcific aortic stenosis and were deemed to be at high or extreme risk of surgery based on assessment by the heart team. The mean age was 84.4 ± 5.3 years, 57% (68 of 120) of patients were women, and the mean Society of Thoracic Surgeons score was 7.1 ± 4.6. The mean baseline aortic valve area was 0.7 ± 0.2 cm(2), and the mean transvalvular pressure gradient was 46.4 ± 15.0 mm Hg. All patients were successfully implanted with a Lotus Valve, and 1-year clinical follow-up was available for 99.2% (119 of 120 of patients). The mean 1-year transvalvular aortic pressure gradient was 12.6 ± 5.7 mm Hg, and the mean valve area was 1.7 ± 0.5 cm(2). A total of 88.6% patients had no or trivial paravalvular aortic regurgitation at 1 year by independent core lab adjudication, and 97.1% of patients were New York Heart Association functional class I or II. At 1 year, the all-cause mortality rate was 10.9% (13 of 119 patients), disabling stroke rate was 3.4% (4 of 119 patients), disabling bleeding rate was 5.9% (7 of 119 patients), with no repeat procedures for valve-related dysfunction. A total of 31.9% (38 of 119 patients) underwent new permanent pacemaker implantation at 1 year. At 1 year of follow-up, the Lotus Valve demonstrated excellent valve hemodynamics, no moderate or

  4. The incidence of transcatheter aortic valve implantation-related heart block in self-expandable Medtronic CoreValve and balloon-expandable Edwards valves.

    PubMed

    Liang, Michael; Devlin, Gerard; Pasupati, Sanjeevan

    2012-04-01

    Transcatheter aortic valve implantation (TAVI) has been performed at Waikato Hospital for high-risk severe symptomatic aortic stenosis patients who are considered unsuitable for conventional cardiac surgery for the last 3 years. The Medtronic CoreValve (MCV) is a self-expandable device, while the Edwards SAPIEN valve (EV) requires the use of a balloon to expand the device. This observational study reports and compares the incidence of heart block in both Medtronic and Edwards transcatheter valves. All patients who underwent TAVI between the periods of 28 August 2008 and 27 July 2011 were included in this study. Preprocedure and daily postprocedure until discharge electrocardiograms (ECG) were obtained prospectively. New onsets of significant atrioventricular (AV) and bundle branch blocks were recorded. Patients with existing pacemaker and those who did not survive the procedure were excluded. Sixty patients underwent TAVI during the study period, of whom 40 (67%) and 20 (33%) patients had MCV and EV implanted, respectively. Seven patients were excluded from the analysis; 38 MCV and 15 EV patients fulfilled the criteria for analysis. Mean age was 80 ± 7 years, 57% were male. Five patients (9%) required permanent pacemaker (PPM) implantation, which occurred exclusively post MCV TAVI (MCV vs EV: 13% vs 0%, respectively; P=.02). The indications of PPM were complete heart block in 3 patients (60%), Mobitz II second-degree heart block in 1 patient (20%), and symptomatic sick sinus syndrome in 1 patient (20%). The incidence of left bundle branch block (LBBB) was increased after the TAVI procedure and was more significant with MCV implants (MCV vs EV: 42% vs 8%, respectively; P<.01). Of note, 2 of the 5 patients (40%) with pre-existing right bundle branch block (RBBB) who underwent TAVI required PPM (P=.01). MCV implantation is associated with a higher incidence of significant AV block requiring PPM implantation and LBBB compared to EV. The overall rate of PPM requirement

  5. Use of an ePTFE-covered nitinol self-expanding stent graft for the treatment off pre-closure device failure during transcatheter aortic valve repla