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.).

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

PubMed

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

2018-05-17

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

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

PubMed

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

2018-04-01

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

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

Surgical Approaches to Aortic Valve Replacement and Repair—Insights and Challenges

PubMed Central

Ramchandani, Mahesh; Reardon, Michael J

2014-01-01

Since 1960, surgical aortic valve replacement (sAVR) had been the only effective treatment for symptomatic severe aortic stenosis until the recent development of transcatheter aortic valve replacement (TAVR). TAVR has offered an alternative, minimally invasive treatment approach particularly for patients whose age or co-morbidities make them unsuitable for sAVR. The rapid and enthusiastic utilization of this new technique has triggered some speculation about the imminent demise of sAVR. We believe that despite the recent advances in TAVR, surgical approach to aortic valve replacement has continued to develop and will continue to be highly relevant in the future. This article will discuss the recent developments and current approaches for sAVR, and how these approaches will keep pace with catheter-based technologies. PMID:29588775

Realistic Vascular Replicator for TAVR Procedures.

PubMed

Rotman, Oren M; Kovarovic, Brandon; Sadasivan, Chander; Gruberg, Luis; Lieber, Baruch B; Bluestein, Danny

2018-04-13

Transcatheter aortic valve replacement (TAVR) is an over-the-wire procedure for treatment of severe aortic stenosis (AS). TAVR valves are conventionally tested using simplified left heart simulators (LHS). While those provide baseline performance reliably, their aortic root geometries are far from the anatomical in situ configuration, often overestimating the valves' performance. We report on a novel benchtop patient-specific arterial replicator designed for testing TAVR and training interventional cardiologists in the procedure. The Replicator is an accurate model of the human upper body vasculature for training physicians in percutaneous interventions. It comprises of fully-automated Windkessel mechanism to recreate physiological flow conditions. Calcified aortic valve models were fabricated and incorporated into the Replicator, then tested for performing TAVR procedure by an experienced cardiologist using the Inovare valve. EOA, pressures, and angiograms were monitored pre- and post-TAVR. A St. Jude mechanical valve was tested as a reference that is less affected by the AS anatomy. Results in the Replicator of both valves were compared to the performance in a commercial ISO-compliant LHS. The AS anatomy in the Replicator resulted in a significant decrease of the TAVR valve performance relative to the simplified LHS, with EOA and transvalvular pressures comparable to clinical data. Minor change was seen in the mechanical valve performance. The Replicator showed to be an effective platform for TAVR testing. Unlike a simplified geometric anatomy LHS, it conservatively provides clinically-relevant outcomes and complement it. The Replicator can be most valuable for testing new valves under challenging patient anatomies, physicians training, and procedural planning.

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

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.

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

PubMed

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

2018-04-01

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

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

PubMed

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

2018-04-01

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

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

PubMed

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

2012-12-01

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

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

PubMed

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

2017-12-01

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

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.

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

PubMed

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

2017-07-01

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

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

PubMed

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

2016-12-26

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

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

PubMed

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

2015-12-28

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

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

PubMed

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

2017-07-01

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

Clinical Outcomes Following Transcatheter Aortic Valve Replacement in Asian Population.

PubMed

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

2016-05-09

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

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

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

PubMed

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

2016-01-01

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

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

PubMed

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

2018-05-01

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

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.

Transcatheter Aortic Valve Replacement by a Novel Suprasternal Approach.

PubMed

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

2018-04-01

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

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

PubMed Central

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

2018-01-01

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

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

PubMed

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

2017-06-01

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

Robot-assisted real-time magnetic resonance image-guided transcatheter aortic valve replacement.

PubMed

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

2016-05-01

Real-time magnetic resonance imaging (rtMRI)-guided transcatheter aortic valve replacement (TAVR) offers improved visualization, real-time imaging, and pinpoint accuracy with device delivery. Unfortunately, performing a TAVR in a MRI scanner can be a difficult task owing to limited space and an awkward working environment. Our solution was to design a MRI-compatible robot-assisted device to insert and deploy a self-expanding valve from a remote computer console. We present our preliminary results in a swine model. We used an MRI-compatible robotic arm and developed a valve delivery module. A 12-mm trocar was inserted in the apex of the heart via a subxiphoid incision. The delivery device and nitinol stented prosthesis were mounted on the robot. Two continuous real-time imaging planes provided a virtual real-time 3-dimensional reconstruction. The valve was deployed remotely by the surgeon via a graphic user interface. In this acute nonsurvival study, 8 swine underwent robot-assisted rtMRI TAVR for evaluation of feasibility. Device deployment took a mean of 61 ± 5 seconds. Postdeployment necropsy was performed to confirm correlations between imaging and actual valve positions. These results demonstrate the feasibility of robotic-assisted TAVR using rtMRI guidance. This approach may eliminate some of the challenges of performing a procedure while working inside of an MRI scanner, and may improve the success of TAVR. It provides superior visualization during the insertion process, pinpoint accuracy of deployment, and, potentially, communication between the imaging device and the robotic module to prevent incorrect or misaligned deployment. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2016-05-01

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

Permanent Pacemaker Implantation after TAVR – Predictors and Impact on Outcomes

PubMed Central

Sinning, Jan-Malte; Hammerstingl, Christoph; Werner, Nikos; Grube, Eberhard; Nickenig, Georg

2015-01-01

The number of patients undergoing transcatheter aortic valve replacement (TAVR) worldwide is increasing steadily. Atrioventricular conduction disturbances, with or without the need for permanent pacemaker (PPM) implantation, are one of the most common adverse events after TAVR. Among transcatheter heart valves (THV), rates of conduction abnormalities vary from less than 10 % to more than 50 %. Depending on the reported data referred to, historical data showed that up to one-third of the patients required implantation of a PPM following TAVR. Although generally considered as a minor complication, PPM may have a profound impact on prognosis and quality of life after TAVR. Current data support the hypothesis that conduction abnormalities leading to pacemaker dependency result from mechanical compression of the conduction system by the prosthesis stent frame and individual predisposing conduction defects such as right bundle-branch block (RBBB). With several large randomised trials and registry studies having been published recently and second generation THV having been introduced, the debate about predictors for pacemaker implantation and their impact on outcome after TAVR is still ongoing. PMID:29588683

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

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

PubMed

Harolds, Jay A

2018-02-01

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

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.

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

PubMed

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

2015-09-21

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

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

PubMed

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

2017-01-01

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

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

PubMed

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

2018-05-17

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

Will Catheter Interventions Replace Surgery for Valve Abnormalities?

PubMed Central

O’Byrne, Michael L; Gillespie, Matthew J

2015-01-01

Purpose of Review Catheter-based valve technologies have evolved rapidly over the last decade. Transcatheter aortic valve replacement (TAVR) has become a routine procedure in high-risk adult patients with calcific aortic stenosis. In patients with congenital heart disease (CHD), transcatheter pulmonary valve replacement represents a transformative technology for right ventricular outflow tract dysfunction with the potential to expand to other indications. This review aims to summarize 1) the current state of the art for transcatheter valve replacement (TVR) in CHD, 2) the expanding indications for TVR, and 3) the technological obstacles to optimizing TVR. Recent findings Multiple case series have demonstrated that TVR with the Melody transcatheter pulmonary valve in properly selected patients is safe, effective, and durable in short-term follow-up. The Sapien transcatheter heart valve represents an alternative device with similar safety and efficacy in limited studies. Innovative use of current valves has demonstrated the flexibility of TVR, while highlighting the need for devices to address the broad range of post-operative anatomies either with a single device or strategies to prepare the outflow tract for subsequent device deployment. Summary The potential of TVR has not been fully realized, but holds promise in treatment of CHD. PMID:24281347

Transfemoral transcatheter aortic valve replacement compared with surgical replacement in patients with severe aortic stenosis and comparable risk: cost-utility and its determinants.

PubMed

Ribera, Aida; Slof, John; Andrea, Rut; Falces, Carlos; Gutiérrez, Enrique; Del Valle-Fernández, Raquel; Morís-de la Tassa, César; Mota, Pedro; Oteo, Juan Francisco; Cascant, Purificació; Altisent, Omar Abdul-Jawad; Sureda, Carlos; Serra, Vicente; García-Del Blanco, Bruno; Tornos, Pilar; Garcia-Dorado, David; Ferreira-González, Ignacio

2015-03-01

To evaluate cost-effectiveness of transfemoral TAVR vs surgical replacement (SAVR) and its determinants in patients with severe symptomatic aortic stenosis and comparable risk. Patients were prospectively recruited in 6 Spanish hospitals and followed up over one year. We estimated adjusted incremental cost-effectiveness ratio (ICER) (Euros per quality-adjusted life-year [QALY] gained) using a net-benefit approach and assessed the determinants of incremental net-benefit of TAVR vs SAVR. We analyzed data on 207 patients: 58, 87 and 62 in the Edwards SAPIEN (ES) TAVR, Medtronic-CoreValve (MC) TAVR and SAVR groups respectively. Average cost per patient of ES-TAVR was €8800 higher than SAVR and the gain in QALY was 0.036. The ICER was €148,525/QALY. The cost of MC-TAVR was €9729 higher than SAVR and the QALY difference was -0.011 (dominated). Results substantially changed in the following conditions: 1) in patients with high preoperative serum creatinine the ICERs were €18,302/QALY and €179,618/QALY for ES and MC-TAVR respectively; 2) a 30% reduction in the cost of TAVR devices decreased the ICER for ES-TAVR to €32,955/QALY; and 3) imputing hospitalization costs from other European countries leads to TAVR being dominant. In countries with relatively low health care costs TAVR is not likely to be cost-effective compared to SAVR in patients with intermediate risk for surgery, mainly because of the high cost of the valve compared to the cost of hospitalization. TAVR could be cost-effective in specific subgroups and in countries with higher hospitalization costs. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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

PubMed

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

2017-01-01

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

Pulmonary Hypertension in Patients With Severe Aortic Stenosis: Prognostic Impact After Transcatheter Aortic Valve Replacement: Pulmonary Hypertension in Patients Undergoing TAVR.

PubMed

Alushi, Brunilda; Beckhoff, Frederik; Leistner, David; Franz, Marcus; Reinthaler, Markus; Stähli, Barbara E; Morguet, Andreas; Figulla, Hans R; Doenst, Torsten; Maisano, Francesco; Falk, Volkmar; Landmesser, Ulf; Lauten, Alexander

2018-04-13

The authors investigated the development of pulmonary hypertension (PH), predictors of PH regression, and its prognostic impact on short, mid-, and long-term outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). PH represents a common finding in patients with AS. Although TAVR is frequently associated with regression of PH, the predictors of reversible PH and its prognostic significance remain uncertain. In this study, 617 consecutive patients undergoing TAVR between 2009 and 2015 were stratified per baseline tertiles of pulmonary artery systolic pressure (PASP) as follows: normal (PASP <34 mm Hg), mild-to-moderate (34 mm Hg ≤ PASP <46 mm Hg), and severe PASP elevation (PASP ≥46 mm Hg). After TAVR, 520 patients with PH at discharge were stratified according to the presence or absence of PASP reduction. Primary outcome was all-cause mortality at 30 days, 1 year, and long-term follow-up at a maximum of 5.9 years. In patients with both mild-to-moderate and severe PH at baseline, PASP decreased significantly at discharge (ΔPASP 3.0 ± 9.3 mm Hg and 12.0 ± 10.0 mm Hg, respectively) and 1 year (ΔPASP 5.0 ± 9.7 mm Hg and 18.0 ± 14.0 mm Hg, respectively). At a median follow-up of 370 days (interquartile range [IQR]: 84 to 500 days), the risk of all-cause mortality was similar among baseline PASP groups at all time intervals evaluated. After TAVR, a significant regression of PH was observed in 46% of patients. Contrarily, patients with residual PH had a higher risk of all-cause mortality at 30 days (hazard ratio [HR]: 3.49, 95% confidence interval [CI]: 1.74 to 6.99; p < 0.001), 1 year (HR: 3.12, 95% CI: 2.06 to 4.72; p < 0.001), and long-term (HR: 2.47, 95% CI: 1.74 to 3.49; p < 0.001). Left ventricular ejection fraction (LVEF) >40% (odds ratio [OR]: 3.56, 95% CI: 2.24 to 5.65; p < 0.001), baseline PASP ≥46 mm Hg (OR: 3.26, 95% CI: 2.07 to 5.12; p < 0.001), absence of concomitant

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

PubMed

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

2014-01-28

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

Outcomes of transcatheter aortic valve replacement using a minimalist approach.

PubMed

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

2018-03-01

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

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

PubMed

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

2013-11-15

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

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

PubMed

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

2017-03-15

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

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

PubMed

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

2015-01-01

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

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

PubMed

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

2018-03-01

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

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

PubMed

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

2017-02-15

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

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

PubMed

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

2017-11-01

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

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

PubMed

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

2018-04-01

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

Impact of anticoagulation therapy on valve haemodynamic deterioration following transcatheter aortic valve replacement.

PubMed

Del Trigo, María; Muñoz-García, Antonio J; Latib, Azeem; Auffret, Vincent; Wijeysundera, Harindra C; Nombela-Franco, Luis; Gutierrez, Enrique; Cheema, Asim N; Serra, Vicenç; Amat-Santos, Ignacio J; Kefer, Joelle; Benitez, Luis Miguel; Leclercq, Florence; Mangieri, Antonio; Le Breton, Hervé; Jiménez-Quevedo, Pilar; Garcia Del Blanco, Bruno; Dager, Antonio; Abdul-Jawad Altisent, Omar; Puri, Rishi; Pibarot, Philippe; Rodés-Cabau, Josep

2018-05-01

To evaluate the changes in transvalvular gradients and the incidence of valve haemodynamic deterioration (VHD) following transcatheter aortic valve replacement (TAVR), according to use of anticoagulation therapy. This multicentre study included 2466 patients (46% men; mean age 81±7 years) who underwent TAVR with echocardiography performed at 12-month follow-up. Anticoagulation therapy was used in 707 patients (28.7%) following TAVR (AC group). A total of 663 patients received vitamin K antagonists, and 44 patients received direct oral anticoagulants. A propensity score matching analysis was performed to adjust for intergroup (AC vs non-AC post-TAVR) differences. A total of 622 patients per group were included in the propensity-matched analysis. VHD was defined as a ≥10 mm Hg increase in the mean transprosthetic gradient at follow-up (vs hospital discharge). The mean clinical follow-up was 29±18 months. The mean transvalvular gradient significantly increased at follow-up in the non-AC group within the global cohort (P=0.003), whereas it remained stable over time in the AC group (P=0.323). The incidence of VHD was significantly lower in the AC group (0.6%) compared with the non-AC group (3.7%, P<0.001), and these significant differences remained within the propensity-matched populations (0.6% vs 3.9% in the AC and non-AC groups, respectively, P<0.001). The occurrence of VHD did not associate with an increased risk of all-cause death (P=0.468), cardiovascular death (P=0.539) or stroke (P=0.170) at follow-up. The lack of anticoagulation therapy post-TAVR was associated with significant increments in transvalvular gradients and a greater risk of VHD. VHD was subclinical in most cases and did not associate with major adverse clinical events. Future randomised trials are needed to determine if systematic anticoagulation therapy post-TAVR would reduce the incidence of VHD. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article

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

A balloon-expandable sheath facilitates transfemoral TAVR in patients with peripheral vascular disease and tortuosity.

PubMed

Goldsweig, Andrew M; Faheem, Osman; Cleman, Michael W; Forrest, John K

2015-06-01

We sought to perform transcatheter aortic valve replacement (TAVR) via the transfemoral approach in patients with peripheral arterial disease (PAD), small caliber ileofemoral vessels and vascular tortuosity. For patients with increased surgical risk, TAVR is associated with a higher 1-year survival rate than surgical aortic valve replacement (SAVR). Transfemoral vascular access for TAVR results in superior outcomes versus procedures performed via other routes in terms of mortality, morbidity and healthcare economics. In many patients, the ability to safely perform the procedure via the transfemoral approach is limited by narrow, diseased and tortuous ileofemoral vasculature. We employed the SoloPath Balloon Expandable TransFemoral Access System (Terumo Med. Corp., Tokyo, Japan) to perform transfemoral TAVR in five patients with PAD, small caliber ileofemoral vessels and vascular tortuosity. We report our experience using this balloon-expandable sheath during 5 cases of transfemoral TAVR in patients with inhospitable ileofemoral vasculature of mean diameter ⩽ 5.8 mm. The unexpanded sheath's malleable structure and hydrophilic coating permitted deployment despite severe stenoses and tortuosity. Subsequent inflation to 18 Fr facilitated successful TAVR. Postprocedural angiography demonstrated no significant vascular access complications. In one case, the entire procedure was performed percutaneously, without common femoral artery surgical cutdown. The SoloPath sheath system permits transfemoral TAVR in patients with PAD small caliber ileofemoral vessels and vascular tortuosity. The transfemoral balloon-expandable sheath allowed these patients to avoid the increased morbidity and mortality risks associated with direct aortic or transapical access. © The Author(s), 2015.

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 ...

Transcatheter aortic valve replacement and vascular complications definitions.

PubMed

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

2014-03-20

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

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

PubMed

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

2017-09-01

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

Transcatheter Aortic Valve Replacement Improves Health Status in Elderly Veterans.

PubMed

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

2018-06-01

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

The Economics of Transcatheter Valve Interventions.

PubMed

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

2017-09-01

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

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

PubMed

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

2017-08-01

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

Systemic vascular load in calcific degenerative aortic valve stenosis: insight from percutaneous valve replacement.

PubMed

Yotti, Raquel; Bermejo, Javier; Gutiérrez-Ibañes, Enrique; Pérez del Villar, Candelas; Mombiela, Teresa; Elízaga, Jaime; Benito, Yolanda; González-Mansilla, Ana; Barrio, Alicia; Rodríguez-Pérez, Daniel; Martínez-Legazpi, Pablo; Fernández-Avilés, Francisco

2015-02-10

Systemic arterial load impacts the symptomatic status and outcome of patients with calcific degenerative aortic stenosis (AS). However, assessing vascular properties is challenging because the arterial tree's behavior could be influenced by the valvular obstruction. This study sought to characterize the interaction between valvular and vascular functions in patients with AS by using transcatheter aortic valve replacement (TAVR) as a clinical model of isolated intervention. Aortic pressure and flow were measured simultaneously using high-fidelity sensors in 23 patients (mean 79 ± 7 years of age) before and after TAVR. Blood pressure and clinical response were registered at 6-month follow-up. Systolic and pulse arterial pressures, as well as indices of vascular function (vascular resistance, aortic input impedance, compliance, and arterial elastance), were significantly modified by TAVR, exhibiting stiffer vascular behavior post-intervention (all, p < 0.05). Peak left ventricular pressure decreased after TAVR (186 ± 36 mm Hg vs. 162 ± 23 mm Hg, respectively; p = 0.003) but remained at >140 mm Hg in 70% of patients. Wave intensity analysis showed abnormally low forward and backward compression waves at baseline, increasing significantly after TAVR. Stroke volume decreased (-21 ± 19%; p < 0.001) and correlated with continuous and pulsatile indices of arterial load. In the 48 h following TAVR, a hypertensive response was observed in 12 patients (52%), and after 6-month follow-up, 5 patients required further intensification of discharge antihypertensive therapy. Vascular function in calcific degenerative AS is conditioned by the upstream valvular obstruction that dampens forward and backward compression waves in the arterial tree. An increase in vascular load after TAVR limits the procedure's acute afterload relief. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Temporal Trends in Quality of Life Outcomes after Transapical TAVR: A PARTNER Trial Substudy

PubMed Central

Gada, Hemal; Kirtane, Ajay J; Wang, Kaijun; Lei, Yang; Magnuson, Elizabeth; Reynolds, Matthew R; Williams, Mathew R; Kodali, Susheel; Vahl, Torsten P; Arnold, Suzanne V; Leon, Martin B; Thourani, Vinod; Szeto, Wilson Y; Cohen, David J

2016-01-01

Background In the PARTNER randomized controlled trial (RCT), which represented the first exposure to transapical transcatheter aortic valve replacement (TA-TAVR) for many clinical sites, high risk patients undergoing TA-TAVR derived similar health-related quality-of-life (HRQoL) outcomes when compared with surgical AVR (SAVR). With increasing experience, it is possible that HRQoL outcomes of TA-TAVR may have improved. Methods and Results We evaluated HRQoL outcomes at 1-, 6-, and 12-month follow-up among 875 patients undergoing TA-TAVR in the PARTNER non-randomized continued access (NRCA) registry, and compared these outcomes with those of the TA-TAVR and SAVR patients in the PARTNER RCT. HRQoL was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short Form-12, and the EuroQoL-5D, with the KCCQ overall summary score serving as the primary endpoint. The NRCA TA-TAVR and RCT TA-TAVR and SAVR groups were generally similar. The primary outcome, the KCCQ summary score, did not differ between the NRCA TA-TAVR and the RCT TA-TAVR group at any follow-up timepoints, although there were small differences in favor of the NRCA cohort on several KCCQ subscales at 1 month. There were no significant differences in follow-up HRQOL between the NRCA-TAVR and the RCT SAVR cohorts on the KCCQ overall summary scale or any of the disease-specific or generic subscales. Conclusions Despite greater experience with TA-TAVR in the NRCA registry, HRQoL outcomes remained similar to those of TA-TAVR in the original RCT cohort and no better than those with SAVR. These findings have important implications for patient selection for TAVR when transfemoral access is not an option. Clinical Trial Registration Placement of AoRTic TraNscathetER Valve [PARTNER] trial; NCT00530894; http://clinicaltrials.gov/show/NCT00530894 PMID:26058718

Local versus general anesthesia for transcatheter aortic valve implantation (TAVR)--systematic review and meta-analysis.

PubMed

Fröhlich, Georg M; Lansky, Alexandra J; Webb, John; Roffi, Marco; Toggweiler, Stefan; Reinthaler, Markus; Wang, Duolao; Hutchinson, Nevil; Wendler, Olaf; Hildick-Smith, David; Meier, Pascal

2014-03-10

The hypothesis of this study was that local anesthesia with monitored anesthesia care (MAC) is not harmful in comparison to general anesthesia (GA) for patients undergoing Transcatheter Aortic Valve Implantation (TAVR).TAVR is a rapidly spreading treatment option for severe aortic valve stenosis. Traditionally, in most centers, this procedure is done under GA, but more recently procedures with MAC have been reported. This is a systematic review and meta-analysis comparing MAC versus GA in patients undergoing transfemoral TAVR. Trials were identified through a literature search covering publications from 1 January 2005 through 31 January 2013. The main outcomes of interest of this literature meta-analysis were 30-day overall mortality, cardiac-/procedure-related mortality, stroke, myocardial infarction, sepsis, acute kidney injury, procedure time and duration of hospital stay. A random effects model was used to calculate the pooled relative risks (RR) with 95% confidence intervals. Seven observational studies and a total of 1,542 patients were included in this analysis. None of the studies were randomized. Compared to GA, MAC was associated with a shorter hospital stay (-3.0 days (-5.0 to -1.0); P = 0.004) and a shorter procedure time (MD -36.3 minutes (-58.0 to -15.0 minutes); P <0.001). Overall 30-day mortality was not significantly different between MAC and GA (RR 0.77 (0.38 to 1.56); P = 0.460), also cardiac- and procedure-related mortality was similar between both groups (RR 0.90 (0.34 to 2.39); P = 0.830). These data did not show a significant difference in short-term outcomes for MAC or GA in TAVR. MAC may be associated with reduced procedural time and shorter hospital stay. Now randomized trials are needed for further evaluation of MAC in the setting of TAVR.

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

PubMed Central

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

2015-01-01

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

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.

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

PubMed

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

2017-07-04

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

Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation.

PubMed

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

2017-12-05

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

Robotic-assisted real-time MRI-guided TAVR: from system deployment to in vivo experiment in swine model.

PubMed

Chan, Joshua L; Mazilu, Dumitru; Miller, Justin G; Hunt, Timothy; Horvath, Keith A; Li, Ming

2016-10-01

Real-time magnetic resonance imaging (rtMRI) guidance provides significant advantages during transcatheter aortic valve replacement (TAVR) as it provides superior real-time visualization and accurate device delivery tracking. However, performing a TAVR within an MRI scanner remains difficult due to a constrained procedural environment. To address these concerns, a magnetic resonance (MR)-compatible robotic system to assist in TAVR deployments was developed. This study evaluates the technical design and interface considerations of an MR-compatible robotic-assisted TAVR system with the purpose of demonstrating that such a system can be developed and executed safely and precisely in a preclinical model. An MR-compatible robotic surgical assistant system was built for TAVR deployment. This system integrates a 5-degrees of freedom (DoF) robotic arm with a 3-DoF robotic valve delivery module. A user interface system was designed for procedural planning and real-time intraoperative manipulation of the robot. The robotic device was constructed of plastic materials, pneumatic actuators, and fiber-optical encoders. The mechanical profile and MR compatibility of the robotic system were evaluated. The system-level error based on a phantom model was 1.14 ± 0.33 mm. A self-expanding prosthesis was successfully deployed in eight Yorkshire swine under rtMRI guidance. Post-deployment imaging and necropsy confirmed placement of the stent within 3 mm of the aortic valve annulus. These phantom and in vivo studies demonstrate the feasibility and advantages of robotic-assisted TAVR under rtMRI guidance. This robotic system increases the precision of valve deployments, diminishes environmental constraints, and improves the overall success of TAVR.

Minimalist transcatheter aortic valve replacement: The new standard for surgeons and cardiologists using transfemoral access?

PubMed

Jensen, Hanna A; Condado, Jose F; Devireddy, Chandan; Binongo, Jose; Leshnower, Bradley G; Babaliaros, Vasilis; Sarin, Eric L; Lerakis, Stamatios; Guyton, Robert A; Stewart, James P; Syed, Amjadullah Q; Mavromatis, Kreton; Kaebnick, Brian; Rajaei, Mohammad Hossein; Tsai, Lillian L; Rahman, Ayaz; Simone, Amy; Keegan, Patricia; Block, Peter C; Thourani, Vinod H

2015-10-01

A minimalist approach for transcatheter aortic valve replacement (MA-TAVR) utilizing transfemoral access under conscious sedation and transthoracic echocardiography is increasing in popularity. This relatively novel technique may necessitate a learning period to achieve proficiency in performing a successful and safe procedure. This report evaluates our MA-TAVR cohort with specific characterization between our early, midterm, and recent experience. We retrospectively reviewed 151 consecutive patients who underwent MA-TAVR with surgeons and interventionists equally as primary operator at Emory University between May 2012 and July 2014. Our institution had performed 300 TAVR procedures before implementation of MA-TAVR. Patient characteristics and early outcomes were compared using Valve Academic Research Consortium 2 definitions among 3 groups: group 1 included the first 50 patients, group 2 included patients 51 to 100, and group 3 included patients 101 to 151. Median age for all patients was 84 years and similar among groups. The majority of patients were men (56%) and the median ejection fraction for all patients was 55% (interquartile range, 38.0%-60.0%). The majority of patients were high-risk surgical candidates with a median Society of Thoracic Surgeons Predicted Risk of Mortality of 10.0% and similar among groups. The overall major stroke rate was 3.3%, major vascular complications occurred in 3% of patients, and greater-than-mild paravalvular leak rate was 7%. In-hospital mortality and morbidity were similar among all 3 groups. In a high-volume TAVR center, transition to MA-TAVR is feasible with acceptable outcomes and a diminutive procedural learning curve. We advocate for TAVR centers to actively pursue the minimalist technique with equal representation by cardiologists and surgeons. Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Beyond adding years to life: health-related quality-of-life and functional outcomes in patients with severe aortic valve stenosis at high surgical risk undergoing transcatheter aortic valve replacement.

PubMed

Deutsch, Marcus-Andre; Bleiziffer, Sabine; Elhmidi, Yacine; Piazza, Nicolo; Voss, Bernhard; Lange, Ruediger; Krane, Markus

2013-11-01

Aortic valve stenosis (AVS) is the most frequent acquired valvular heart disease in western industrialized countries and its prevalence considerably increases with age. Once becoming symptomatic severe AVS has a very poor prognosis. Progressive and rapid symptom deterioration leads to an impairment of functional status and compromised healthrelated quality-of-life (HrQoL) simultaneously. Until recently, surgical aortic valve replacement (SAVR) has been the only effective treatment option for improving symptoms and prolonging survival. Transcatheter aortic valve replacement (TAVR) emerged as an alternative treatment modality for those patients with severe symptomatic AVS in whom the risk for SAVR is considered prohibitive or too high. TAVR has gained clinical acceptance with almost startling rapidity and has even quickly become the standard of care for the treatment of appropriately selected individuals with inoperable AVS during recent years. Typically, patients currently referred for and treated by TAVR are elderly with a concomitant variable spectrum of multiple comorbidities, disabilities and limited life expectancy. Beyond mortality and morbidity, the assessment of HrQoL is of paramount importance not only to guide patient-centered clinical decision-making but also to judge this new treatment modality. As per current evidence, TAVR significantly improves HrQoL in high-surgical risk patients with severe AVS with sustained effects up to two years when compared with optimal medical care and demonstrates comparable benefits relative to SAVR. Along with a provision of a detailed overview of the current literature regarding functional and HrQoL outcomes in patients undergoing TAVR, this review article addresses specific considerations of the HrQoL aspect in the elderly patient and finally outlines the implications of HrQoL outcomes for medico-economic deliberations.

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

PubMed

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

2013-07-01

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

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

PubMed

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

2018-05-01

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

Early Transcatheter Aortic Valve Function With and Without Therapeutic Anticoagulation.

PubMed

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

2017-11-01

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

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

PubMed

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

2017-05-01

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

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

PubMed

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

2015-05-26

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

TAVR Through Heavily Calcified Aorta Following Atheroma Retrieval With the "Elevator" Technique.

PubMed

Senguttuvan, N Boopathy; Ellozy, Sharif; Tejani, Furqan; Kovacic, Jason; Kini, Annapoorna S; Sharma, Samin K; Dangas, George D

2015-10-01

An 86-year-old Caucasian female with severe symptomatic, inoperable aortic stenosis was accepted for high-risk transfemoral transcatheter aortic valve replacement (TAVR) approach due to severe calcification of the aorta. During initial passage of a 22 Fr sheath, there was dislodgment with proximal migration of a circumferential tunnel of calcium from the infrarenal aorta. A novel "elevator" technique was used to secure and retrieve the dislodged aorta en bloc back to its original infrarenal aortic position and allow in situ fixation with stenting. A new TAVR system was then successfully placed through the stent and a 23 mm Edwards Sapien valve (Edwards Lifesciences) was implanted as planned. In case of calcification protruding into the lumen of the aorta and limiting the passage of the large valve delivery system sheath, the obstruction can be managed by stenting the calcification against the luminal wall under fluoroscopic and intravascular-ultrasound guidance, allowing successful passage of the valve delivery system. The elevator technique allows axial transportation of any calcified vascular fragments, should they become dislodged.

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

PubMed

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

2017-09-01

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

Quantitative Prediction of Paravalvular Leak in Transcatheter Aortic Valve Replacement Based on Tissue-Mimicking 3D Printing.

PubMed

Qian, Zhen; Wang, Kan; Liu, Shizhen; Zhou, Xiao; Rajagopal, Vivek; Meduri, Christopher; Kauten, James R; Chang, Yung-Hang; Wu, Changsheng; Zhang, Chuck; Wang, Ben; Vannan, Mani A

2017-07-01

This study aimed to develop a procedure simulation platform for in vitro transcatheter aortic valve replacement (TAVR) using patient-specific 3-dimensional (3D) printed tissue-mimicking phantoms. We investigated the feasibility of using these 3D printed phantoms to quantitatively predict the occurrence, severity, and location of any degree of post-TAVR paravalvular leaks (PVL). We have previously shown that metamaterial 3D printing technique can be used to create patient-specific phantoms that mimic the mechanical properties of biological tissue. This may have applications in procedural planning for cardiovascular interventions. This retrospective study looked at 18 patients who underwent TAVR. Patient-specific aortic root phantoms were created using the tissue-mimicking 3D printing technique using pre-TAVR computed tomography. The CoreValve (self-expanding valve) prostheses were deployed in the phantoms to simulate the TAVR procedure, from which post-TAVR aortic root strain was quantified in vitro. A novel index, the annular bulge index, was measured to assess the post-TAVR annular strain unevenness in the phantoms. We tested the comparative predictive value of the bulge index and other known predictors of post-TAVR PVL. The maximum annular bulge index was significantly different among patient subgroups that had no PVL, trace-to-mild PVL, and moderate-to-severe PVL (p = 0.001). Compared with other known PVL predictors, bulge index was the only significant predictor of moderate-severe PVL (area under the curve = 95%; p < 0.0001). Also, in 12 patients with post-TAVR PVL, the annular bulge index predicted the major PVL location in 9 patients (accuracy = 75%). In this proof-of-concept study, we have demonstrated the feasibility of using 3D printed tissue-mimicking phantoms to quantitatively assess the post-TAVR aortic root strain in vitro. A novel indicator of the post-TAVR annular strain unevenness, the annular bulge index, outperformed the other

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

PubMed

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

2018-03-01

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

Diabetes mellitus is associated with increased acute kidney injury and 1-year mortality after transcatheter aortic valve replacement: A meta-analysis.

PubMed

Mina, George S; Gill, Priyanka; Soliman, Demiana; Reddy, Pratap; Dominic, Paari

2017-09-01

Diabetes mellitus (DM) is associated with adverse outcomes after surgical aortic valve replacement. However, there are conflicting data on the impact of DM on outcomes of transcatheter aortic valve replacement (TAVR). DM is associated with poor outcomes after different cardiac procedures. Therefore, DM can also be associated with poor outcomes after TAVR. We searched PubMed and Cochrane Central Register of Controlled Trials for studies that evaluated outcomes after TAVR and stratified at least 1 of the studied endpoints by DM status. The primary endpoint was all-cause mortality at 1 year. Secondary endpoints were early (up to 30 days) mortality, acute kidney injury (AKI), cerebrovascular accident (CVA), major bleeding, and major vascular complications. Pooled odds ratio (OR) and 95% confidence interval (CI) were calculated using random effects models. We included 64 studies with a total of 38 686 patients. DM was associated with significantly higher 1-year mortality (OR: 1.14, 95% CI: 1.04-1.26, P = 0.008) and periprocedural AKI (OR: 1.28, 95% CI: 1.08-1.52, P = 0.004). On the other hand, there were no significant differences between diabetics and nondiabetics in early mortality, CVAs, major bleeding, or major vascular complications. DM is associated with increased 1-year mortality and periprocedural AKI in patients undergoing TAVR. The results of this study suggest that DM is a predictor of adverse outcomes in patients undergoing TAVR. © 2017 Wiley Periodicals, Inc.

Death and Dialysis After Transcatheter Aortic Valve Replacement: An Analysis of the STS/ACC TVT Registry.

PubMed

Hansen, James W; Foy, Andrew; Yadav, Pradeep; Gilchrist, Ian C; Kozak, Mark; Stebbins, Amanda; Matsouaka, Roland; Vemulapalli, Sreekanth; Wang, Alice; Wang, Dee Dee; Eng, Marvin H; Greenbaum, Adam B; O'Neill, William O

2017-10-23

The authors sought to elucidate the true incidence of renal replacement therapy (RRT) after transcatheter aortic valve replacement (TAVR). There is a wide discrepancy in the reported rate of RRT after TAVR (1.4% to 40%). The true incidence of RRT after TAVR is unknown. The STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) registry was linked to the Centers for Medicare & Medicaid database to identify all patients that underwent TAVR from November 2011 through September 2015 and their outcomes. The authors compared rates of death, new RRT, and a composite of both as a function of pre-procedure glomerular filtration rate (GFR), both in stages of chronic kidney disease (CKD), as well as on a continuous scale. Pre-procedure GFR is associated with the risk of death and new RRT after TAVR when GFR is <60 ml/min/m 2 , and increases significantly when GFR falls below 30 ml/min/m 2 . Incremental increases in GFR of 5 ml/min/m 2 were statistically significant (unadjusted hazard ratio: 0.71; p < 0.001) at 30 days, and continued to be significant at 1 year when pre-procedure GFR was <60 ml/min/m 2 . One in 3 CKD stage 4 patients will be dead within 1 year, with 14.6% (roughly 1 in 6) requiring dialysis. In CKD stage 5, more than one-third of patients will require RRT within 30 days; nearly two-thirds will require RRT at 1 year. In both unadjusted and adjusted analysis, pre-procedural GFR was associated with the outcomes of death and new RRT. Increasing CKD stage leads to an increased risk of death and/or RRT. Continuous analysis showed significant differences in outcomes in all levels of CKD when GFR was <60 ml/min/m 2 . Pre-procedure GFR should be considered when selecting CKD patients for TAVR. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2017-11-27

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

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

PubMed

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

2018-01-08

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

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

PubMed

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

2016-12-15

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

Pros and cons of transcatheter aortic valve implantation (TAVI)

PubMed Central

Terré, Juan A.; George, Isaac

2017-01-01

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

Should TAVR be Performed in Nonagenarians? Insights from the STS/ACC TVT Registry

PubMed Central

Arsalan, Mani; Szerlip, Molly; Vemulapalli, Sreekanth; Holper, Elizabeth M.; Arnold, Suzanne V.; Li, Zhuokai; DiMaio, Michael J.; Rumsfeld, John S.; Brown, David L.; Mack, Michael J.

2017-01-01

Background Despite clinical trial evidence and clinical experience supporting the efficacy of transcatheter aortic valve replacement (TAVR), data demonstrating the benefit of TAVR specifically in the very elderly patients are limited, as they often represent only a small proportion of the clinical trial populations. Objectives To compare the outcomes of nonagenarians to younger patients undergoing TAVR in current clinical practice. Methods National U.S. data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry were analyzed. Outcomes at 30-days and 1-year were compared between patients ≥90 vs <90 years of age using cumulative incidence curves. Quality of life was assessed with the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Results Between November 2011 and September 2014, 24,025 patients underwent TAVR in 329 participating hospitals, of which 3,773 (15.7%) were age ≥90. The 30-day and 1-year mortality was significantly higher among nonagenarians (≥90 vs. <90: 30-day: 8.8% vs. 5.9%, p<0.001; 1-year: 24.8% vs. 22.0%, p<0.001, absolute risk 2.8%, relative risk 12.7%). However, nonagenarians had a higher mean STS PROM score(10.9% vs. 8.1%; p<0.001) and therefore had similar ratios of observed to expected rates of 30-day death (≥90 vs. <90: 0.81, 95% CI 0.70–0.92 vs. 0.72, 95% CI 0.67–0.78). There were no differences in the rates of stroke, aortic valve reintervention or myocardial infarction at 30-days or 1-year. Nonagenarians had lower (worse) median KCCQ-12 scores at 30-days; however, there was no significant difference at 1-year. Conclusions In current U.S. clinical practice, approximately 16% of patients undergoing TAVR are ≥90 years of age. Although 30-day and 1-year mortality was statistically higher compared with younger patients undergoing TAVR, the absolute and relative differences were clinically modest. TAVR also improves quality of life to the same degree in

Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study.

PubMed

Windecker, Stephan; Tijssen, Jan; Giustino, Gennaro; Guimarães, Ana H C; Mehran, Roxana; Valgimigli, Marco; Vranckx, Pascal; Welsh, Robert C; Baber, Usman; van Es, Gerrit-Anne; Wildgoose, Peter; Volkl, Albert A; Zazula, Ana; Thomitzek, Karen; Hemmrich, Melanie; Dangas, George D

2017-02-01

Optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) is unknown and determined empirically. The direct factor Xa inhibitor rivaroxaban may potentially reduce TAVR-related thrombotic complications and premature valve failure. GALILEO is an international, randomized, open-label, event-driven, phase III trial in more than 1,520 patients without an indication for oral anticoagulation who underwent a successful TAVR (ClinicalTrials.govNCT02556203). Patients are randomized (1:1 ratio), 1 to 7days after a successful TAVR, to either a rivaroxaban-based strategy or an antiplatelet-based strategy. In the experimental arm, subjects receive rivaroxaban (10mg once daily [OD]) plus acetylsalicylic acid (ASA, 75-100mg OD) for 90days followed by rivaroxaban alone. In the control arm, subjects receive clopidogrel (75mg OD) plus ASA (as above) for 90days followed by ASA alone. In case new-onset atrial fibrillation occurs after randomization, full oral anticoagulation will be implemented with maintenance of the original treatment assignment. The primary efficacy end point is the composite of all-cause death, stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, and systemic embolism. The primary safety end point is the composite of life-threatening, disabling, and major bleeding, according to the Valve Academic Research Consortium definitions. GALILEO will test the hypothesis that a rivaroxaban-based antithrombotic strategy reduces the risk of thromboembolic complications post-TAVR with an acceptable risk of bleeding compared with the currently recommended antiplatelet therapy-based strategy in subjects without need of chronic oral anticoagulation. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

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

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

PubMed

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

2018-02-01

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

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

PubMed

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

2017-05-22

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

Clinical Relevance of Baseline TCP in Transcatheter Aortic Valve Replacement.

PubMed

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

2017-10-01

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

Variability in Antithrombotic Therapy Regimens Peri-TAVR: A Single Academic Center Experience.

PubMed

Rossi, Jeffrey E; Noll, Andrew; Bergmark, Brian; McCabe, James M; Nemer, David; Okada, David R; Vasudevan, Anant; Davidson, Michael; Welt, Frederick; Eisenhauer, Andrew; Shah, Pinak; Giugliano, Robert

2015-12-01

The aim of this study was to describe peri-procedural antithrombotic use in patients undergoing transcatheter aortic valve replacement (TAVR) at a single academic medical center. Retrospective collection of antiplatelet and anticoagulant use during the index hospitalization for all patients undergoing TAVR at our institution from April 2009 through March 2014. Of a total of 255 patients undergoing the procedure, 132 (51%) had an indication for anticoagulation pre-TAVR and 92 (70% of those with an indication) were on treatment. On discharge, 106 patients (44% of total surviving to discharge, 73% of those surviving with an indication for anticoagulation) were treated with oral anticoagulation. Of these patients, 89 (84%) were discharged on aspirin and an oral anticoagulant without clopidogrel. Only 122 (51% of total patients) were discharged on the regimen of aspirin and clopidogrel alone. Peri-procedural antithrombotic regimens vary greatly following TAVR. More than half of patients have an indication for anticoagulation following the procedure. Most patients at our institution who require anticoagulation are discharged on aspirin and an oral anticoagulant, though the optimal regimen requires further investigation.

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

PubMed

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

2017-08-24

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

Outcomes for the Commercial Use of Self-Expanding Prostheses in Transcatheter Aortic Valve Replacement: A Report From the STS/ACC TVT Registry.

PubMed

Sorajja, Paul; Kodali, Susheel; Reardon, Michael J; Szeto, Wilson Y; Chetcuti, Stanley J; Hermiller, James; Chenoweth, Sharla; Adams, David H; Popma, Jeffrey J

2017-10-23

The authors sought to compare the outcomes of commercial transcatheter aortic valve replacement (TAVR) with the repositionable Evolut R platform to those observed with the CoreValve device in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry. TAVR continues to evolve, with rapid adoption of iterative changes for commercial practice. Insight into the outcomes of this adoption is needed. Patients in the TVT Registry who had TAVR using a 23-, 26-, or 29-mm self-expanding prosthesis were enrolled. Site-reported events for procedural, in-hospital, and 30-day outcomes were examined. Between January 2014 and April 2016, 9,616 patients underwent TAVR with a self-expanding prosthesis with data entered in the TVT Registry. Compared with patients treated with CoreValve TAVR, those who received Evolut R TAVR had a lower STS-PROM score (8.0 ± 5.4% vs. 8.7 ± 5.3%; p < 0.001), more iliofemoral access (91.6% vs. 89.2%; p < 0.001), and more frequently had conscious sedation (27.4% vs. 12.7%; p < 0.001). With Evolut R TAVR, there was less need for a second prosthesis (2.2% vs. 4.5%; p < 0.001), less device migration (0.2% vs. 0.6%; p = 0.01), a lower incidence of moderate/severe paravalvular regurgitation (post-procedure, 4.4% vs. 6.2%; p < 0.001), and shorter median hospital stay (4.0 vs. 5.0 days; p < 0.001). Patients treated with Evolut R TAVR had greater device success (96.3% vs. 94.9%; p = 0.001). At 30 days, Evolut R patients had both lower mortality (3.7% vs. 5.3%; p < 0.001) and less need for a pacemaker (18.3% vs. 20.1%; p = 0.03). Commercial adoption of the Evolut R platform is associated with significant improvements in acute outcomes for patients undergoing TAVR for aortic stenosis. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Conduction disturbances after TAVR: Electrophysiological studies and pacemaker dependency.

PubMed

Makki, Nader; Dollery, Jenn; Jones, Danielle; Crestanello, Juan; Lilly, Scott

Permanent pacemaker (PPM) placement occurs in 5-20% of patients after transcatheter aortic valve replacement (TAVR). Although predictors of pacemaker implantation have been established, features that predispose patients to pacemaker utilization on follow up have not been widely reported. We performed a retrospective review of patients undergoing commercial TAVR between 2011 and 2016. We collated patients that underwent in-hospital PPM implantation and had a follow up of at least 3months. Data abstraction was performed for electrophysiological studies (EPS), pacemaker indication, timing, and device interrogation for pacemaker dependency on follow up. A total of 24 patients received in-hospital PPM post-TAVR (14% of total cohort), and mean follow up was 22months. Indications for PPM included resting complete heart block (CHB; 15/24, 63%), left bundle branch block and abnormal electrophysiological study (EPS; 7/24, 29%), alternating bundle branch block (1/24, 4%) and tachy-brady syndrome (1/24, 4%). Pacemaker dependency (underlying ventricular asystole, complete heart block, or >50% pacing) occurred in 8/24 patients (33%) during follow-up, 7 of whom had resting CHB, and one with CHB invoked during EPS. Pacemaker dependency after TAVR is common among those that exhibited CHB, but not among those with a prolonged HV delay during EPS. Although preliminary, these observations are relevant to management of rhythm disturbances after TAVR, and may inform the practice of EPS-based PPM implantation. Copyright © 2017 Elsevier Inc. All rights reserved.

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

PubMed

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

2016-01-01

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

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

PubMed Central

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

2017-01-01

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

Surgeon Involvement in Transcatheter Aortic Valve Replacement in the United States: A 2016 Society of Thoracic Surgeons Survey.

PubMed

Bavaria, Joseph E; Prager, Richard L; Naunheim, Keith S; Allen, Mark S; Higgins, Robert S D; Thourani, Vinod H; MacGillivray, Thomas E; Boden, Natalie; Sabik, Joseph F

2017-09-01

The Society of Thoracic Surgeons (STS) surveyed cardiothoracic surgeon participants in its Adult Cardiac Surgery Database (ACSD) to learn the extent of surgeon involvement in transcatheter aortic valve replacement (TAVR) procedures. An electronic survey was delivered to 2,594 surgeons in June 2016. When the survey closed 2 weeks later, 487 completed surveys had been submitted for a response rate of 18.8%. Among the 487 participants in the ACSD who responded to the survey, 410 (84.2%) reported that TAVR was performed at their institutions. Approximately three-quarters reported that they performed TAVR procedures as part of a heart team (77.5%; 313 of 404), cardiologists and cardiothoracic surgeons were jointly responsible for TAVR referrals (83.7%; 339 of 405), and TAVR programs were administered either jointly by the cardiology and cardiac surgery departments or exclusively by the cardiac surgery department (73.3%; 297 of 405). A majority were involved in the pre-, intra-, and postoperative care of patients undergoing TAVR, with 91.4% (370 of 405) reporting participation in multidisciplinary meetings, at least 50% regularly performing technical aspects in 10 of 11 conduct of operation categories, and 86.6% (266 of 307) caring for patients undergoing TAVR after the procedure. Cardiac surgeons in the United States are active participants in the management of patients with aortic stenosis as part of the heart team. The STS survey found that not only were they actively involved in the treatment decision-making process but they also played a significant role in the valve procedure, including deployment and postprocedural care. The heart team model continues to evolve and should be expanded into other areas of structural heart disease. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

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

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

PubMed

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

2018-05-15

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

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

PubMed

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

2015-12-01

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

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

PubMed

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

2018-04-09

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

Atrioventricular and intraventricular block after transcatheter aortic valve implantation.

PubMed

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

2018-06-24

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

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

PubMed

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

2018-02-22

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

Analysis of the additional costs of clinical complications in patients undergoing transcatheter aortic valve replacement in the German Health Care System.

PubMed

Gutmann, Anja; Kaier, Klaus; Sorg, Stefan; von Zur Mühlen, Constantin; Siepe, Matthias; Moser, Martin; Geibel, Annette; Zirlik, Andreas; Ahrens, Ingo; Baumbach, Hardy; Beyersdorf, Friedhelm; Vach, Werner; Zehender, Manfred; Bode, Christoph; Reinöhl, Jochen

2015-01-20

This study aims at analyzing complication-induced additional costs of patients undergoing transcatheter aortic valve replacement (TAVR). In a prospective observational study, a total of 163 consecutive patients received either transfemoral (TF-, n=97) or transapical (TA-) TAVR (n=66) between February 2009 and December 2012. Clinical endpoints were categorized according to VARC-2 definitions and in-hospital costs were determined from the hospital perspective. Finally, the additional costs of complications were estimated using multiple linear regression models. TF-TAVR patients experienced significantly more minor access site bleeding, major non-access site bleeding, minor vascular complications, stage 2 acute kidney injury (AKI) and permanent pacemaker implantation. Total in-hospital costs did not differ between groups and were on average €40,348 (SD 15,851) per patient. The average incremental cost component of a single complication was €3438 (p<0.01) and the estimated cost of a TF-TAVR without complications was €34,351. The complications associated with the highest additional costs were life-threatening non-access site bleeding (€47,494; p<0.05), stage 3 AKI (€20,468; p<0.01), implantation of a second valve (€16,767; p<0.01) and other severe cardiac dysrhythmia (€10,611 p<0.05). Overall, the presence of complication-related in-hospital mortality increased costs. Bleeding complications, severe kidney failure, and implantation of a second valve were the most important cost drivers in our TAVR patients. Strategies and advances in device design aimed at reducing these complications have the potential to generate significant in-hospital cost reductions for the German Health Care System. Copyright © 2014. Published by Elsevier Ireland Ltd.

Transapical Implantation of a 2nd-Generation JenaValve Device in Patient with Extremely High Surgical Risk

PubMed Central

Mieres, Juan; Menéndez, Marcelo; Fernández-Pereira, Carlos; Rubio, Miguel; Rodríguez, Alfredo E.

2015-01-01

Transcatheter Aortic Valve Replacement (TAVR) is performed in patients who are poor surgical candidates. Many patients have inadequate femoral access, and alternative access sites have been used such as the transapical approach discussed in this paper. We present an elderly and fragile patient not suitable for surgery for unacceptable high risk, including poor ventricular function, previous myocardial infarction with percutaneous coronary intervention, pericardial effusion, and previous cardiac surgery with replacement of mechanical mitral valve. Transapical aortic valve replacement with a second-generation self-expanding JenaValve is performed. The JenaValve is a second-generation transapical TAVR valve consisting of a porcine root valve mounted on a low-profile nitinol stent. The valve is fully retrievable and repositionable. We discuss transapical access, implantation technique, and feasibility of valve implantation in this extremely high surgical risk patient. PMID:26346128

Transapical Implantation of a 2nd-Generation JenaValve Device in Patient with Extremely High Surgical Risk.

PubMed

Mieres, Juan; Menéndez, Marcelo; Fernández-Pereira, Carlos; Rubio, Miguel; Rodríguez, Alfredo E

2015-01-01

Transcatheter Aortic Valve Replacement (TAVR) is performed in patients who are poor surgical candidates. Many patients have inadequate femoral access, and alternative access sites have been used such as the transapical approach discussed in this paper. We present an elderly and fragile patient not suitable for surgery for unacceptable high risk, including poor ventricular function, previous myocardial infarction with percutaneous coronary intervention, pericardial effusion, and previous cardiac surgery with replacement of mechanical mitral valve. Transapical aortic valve replacement with a second-generation self-expanding JenaValve is performed. The JenaValve is a second-generation transapical TAVR valve consisting of a porcine root valve mounted on a low-profile nitinol stent. The valve is fully retrievable and repositionable. We discuss transapical access, implantation technique, and feasibility of valve implantation in this extremely high surgical risk patient.

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.

Advanced 3-D analysis, client-server systems, and cloud computing-Integration of cardiovascular imaging data into clinical workflows of transcatheter aortic valve replacement.

PubMed

Schoenhagen, Paul; Zimmermann, Mathis; Falkner, Juergen

2013-06-01

Degenerative aortic stenosis is highly prevalent in the aging populations of industrialized countries and is associated with poor prognosis. Surgical valve replacement has been the only established treatment with documented improvement of long-term outcome. However, many of the older patients with aortic stenosis (AS) are high-risk or ineligible for surgery. For these patients, transcatheter aortic valve replacement (TAVR) has emerged as a treatment alternative. The TAVR procedure is characterized by a lack of visualization of the operative field. Therefore, pre- and intra-procedural imaging is critical for patient selection, pre-procedural planning, and intra-operative decision-making. Incremental to conventional angiography and 2-D echocardiography, multidetector computed tomography (CT) has assumed an important role before TAVR. The analysis of 3-D CT data requires extensive post-processing during direct interaction with the dataset, using advance analysis software. Organization and storage of the data according to complex clinical workflows and sharing of image information have become a critical part of these novel treatment approaches. Optimally, the data are integrated into a comprehensive image data file accessible to multiple groups of practitioners across the hospital. This creates new challenges for data management requiring a complex IT infrastructure, spanning across multiple locations, but is increasingly achieved with client-server solutions and private cloud technology. This article describes the challenges and opportunities created by the increased amount of patient-specific imaging data in the context of TAVR.

Inhospital and Post-discharge Changes in Renal Function After Transcatheter Aortic Valve Replacement.

PubMed

Blair, John E A; Brummel, Kent; Friedman, Julie L; Atri, Prashant; Sweis, Ranya N; Russell, Hyde; Ricciardi, Mark J; Malaisrie, S Chris; Davidson, Charles J; Flaherty, James D

2016-02-15

The aim of this study was to determine the influence of inhospital and post-discharge worsening renal function (WRF) on prognosis after transcatheter aortic valve replacement (TAVR). Severe chronic kidney disease and inhospital WRF are both associated with poor outcomes after TAVR. There are no data available on post-discharge WRF and outcomes. This was a single-center study evaluating all TAVR from June 1, 2008, to June 31, 2014. WRF was defined as an increase in serum creatinine of ≥0.3 mg/dl. Inhospital WRF was measured from day 0 until discharge or day 7 if the hospitalization was >7 days. Post-discharge WRF was measured at 30 days after discharge. Descriptive statistics, Kaplan-Meier time-to-event analysis, and multivariate logistic regression were used. In a series of 208 patients who underwent TAVR, 204 with complete renal function data were used in the inhospital analysis and 168 who returned for the 30-day follow-up were used in the post-discharge analysis. Inhospital WRF was seen in 28%, whereas post-discharge WRF in 12%. Inhospital and post-discharge WRF were associated with lower rates of survival; however, after multivariate analysis, only post-discharge WRF remained a predictor of 1-year mortality (hazard ratio 1.18, p = 0.030 for every 1 mg/dl increase in serum creatinine). In conclusion, the rate of inhospital WRF is higher than the rate of post-discharge WRF after TAVR, and post-discharge WRF is more predictive of mortality than inhospital WRF. Copyright © 2016 Elsevier Inc. All rights reserved.

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

PubMed

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

2017-11-01

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

Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach): outcomes and cost analysis.

PubMed

Babaliaros, Vasilis; Devireddy, Chandan; Lerakis, Stamatios; Leonardi, Robert; Iturra, Sebastian A; Mavromatis, Kreton; Leshnower, Bradley G; Guyton, Robert A; Kanitkar, Mihir; Keegan, Patricia; Simone, Amy; Stewart, James P; Ghasemzadeh, Nima; Block, Peter; Thourani, Vinod H

2014-08-01

The aim of this study was to compare transfemoral transcatheter aortic valve replacement (TF TAVR) performed in a catheterization laboratory (minimalist approach [MA]) with TF TAVR performed in a hybrid operating room (standard approach [SA]). A MA-TF TAVR can be performed without general anesthesia, transesophageal echocardiography, or a surgical hybrid room. The outcomes and cost of MA-TF TAVR compared with those of the SA have not been described. Patients who underwent elective, percutaneous TF TAVR using the Edwards Sapien valve (Edwards Lifesciences, Irvine, California) were studied. Baseline characteristics, outcomes, and hospital costs of MA-TF TAVR and SA-TF TAVR were compared. A total of 142 patients were studied (MA-TF TAVR, n = 70 and SA-TF TAVR, n = 72). There were no differences in baseline comorbidities (Society of Thoracic Surgeons score, 10.6 ± 4.3 vs. 11.4 ± 5.8; p = 0.35). All procedures in the MA-TF TAVR group were successful; 1 patient was intubated. Three patients in the SA-TF TAVR group had procedure-related death. Procedure room time (150 ± 48 min vs. 218 ± 56 min, p < 0.001), total intensive care unit time (22 h vs. 28 h, p < 0.001), length of stay from procedure to discharge (3 days vs. 5 days, p < 0.001), and cost ($45,485 ± 14,397 vs. $55,377 ± 22,587, p < 0.001) were significantly less in the MA-TF TAVR group. Mortality at 30 days was not significantly different in the MA-TF TAVR group (0 vs. 6%, p = 0.12) and 30-day stroke/transient ischemic attack was similar (4.3% vs. 1.4%, p = 0.35). Moderate or severe paravalvular leak and device success were similar in the MA-TF TAVR and SA-TF TAVR groups (3% vs. 5.8%, p = 0.4 and 90% vs. 88%, p = 0.79, respectively) at 30 days. At a median follow-up of 435 days, there was no significant difference in survival (MA-TF TAVR, 83% vs. SA-TF TAVR, 82%; p = 0.639). MA-TF TAVR can be performed with minimal morbidity and mortality and equivalent effectiveness compared with SA-TF TAVR. The shorter

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

PubMed

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

2017-07-04

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

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

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

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

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

PubMed

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

2017-01-01

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

Beyond the five-year horizon: long-term outcome of high-risk and inoperable patients undergoing TAVR with first-generation devices.

PubMed

Deutsch, Marcus-André; Erlebach, Magdalena; Burri, Melchior; Hapfelmeier, Alexander; Witt, Olivia Ganga; Ziegelmueller, Johannes Amadeus; Wottke, Michael; Ruge, Hendrik; Krane, Markus; Piazza, Nicolo; Bleiziffer, Sabine; Lange, Rüdiger

2018-05-20

We sought to determine the long-term outcome of high-risk patients who underwent transcatheter aortic valve replacement (TAVR) with first-generation devices with a focus on the identification of predictors for mortality and valve durability. Consecutive patients in our prospective single-centre registry undergoing TAVR with first-generation devices (n=214 CoreValve; n=86 SAPIEN) between 06/2007 and 07/2009 were retrospectively analysed (n=300, mean age 81.43±6.55 years, mean STS score 6.5±4.5%). Kaplan-Meier estimates of survival and the Cox proportional hazards model were used to identify independent predictors of all-cause-mortality. At 1, 5, and 7 years, estimated survival rates were 76.0%, 40.2%, and 23.2%, respectively. Age-adjusted baseline predictors of mortality included atrial fibrillation, impaired kidney function, peripheral artery disease, and mitral regurgitation (≥moderate). Baseline risk-adjusted procedure-related predictors for all-cause mortality included acute kidney injury, neurological events, major vascular complications, and major/life-threatening bleeding. At both five and six years, 78.2% of surviving patients were in NYHA Class I or II. PVL was ≤mild in the majority of patients at discharge and throughout follow-up. At seven years, the overall crude cumulative incidence of structural valve deterioration according to the 2017 EAPCI/ESC/EACTS definition was 14.9% (CoreValve 11.8% vs. SAPIEN 22.6%; p=0.01). Seven years after TAVR, 23.2% of high-risk patients were still alive. Independent predictors of all-cause mortality included both patient- and procedure-related factors. With a cumulative incidence of 14.9% at seven years, there is some suggestion that SVD post TAVR may become increasingly relevant during longer-term follow-up.

Vascular Assessment for Transcatheter Aortic Valve Replacement: Intravascular Ultrasound Compared With Computed Tomography.

PubMed

Essa, Essa; Makki, Nader; Bittenbender, Peter; Capers, Quinn; George, Barry; Rushing, Gregory; Crestanello, Juan; Boudoulas, Konstantinos Dean; Lilly, Scott M

2016-12-01

Assessment of the femoral and iliac arteries is essential prior to transcatheter aortic valve replacement (TAVR). It is critical for establishing candidacy for a femoral approach, and can help predict vascular complications. Although computed tomography angiography (CTA) is the standard imaging modality, it has limitations. This study compared CTA with intravascular ultrasound (IVUS) in patients undergoing TAVR evaluation. Fifteen patients undergoing pre-TAVR coronary angiography and hemodynamic assessment were recruited. Following coronary angiography, patients underwent distal aortography, bilateral iliac and femoral arteriography, and IVUS assessment. Vascular tortuosity, minimum lumen diameter, and cross-sectional area were obtained and the findings were compared with those obtained from CTA. Correlation between IVUS and CTA was strong for minimum luminal diameter (r=0.62). Concordance was also strong between CTA and invasive iliofemoral angiography for assessment of tortuosity (r=0.75). Utilizing Bland-Altman analysis, vessel diameters obtained by IVUS were consistently greater than those obtained by CTA. The angiography and IVUS strategy was associated with a lower overall mean contrast utilization (29 cc vs 100 cc; P<.001), reduced mean radiation exposure (527 mGy vs 998 mGy; P=.045), and no significant difference in mean test duration (13.3 minutes vs 10 minutes; P=.12). For femoral and iliac arterial assessment prior to TAVR, IVUS is a viable alternative to CTA with comparable accuracy, and the potential for less contrast use and less radiation exposure. IVUS is also a valuable adjunct to CTA in patients with borderline femoral access diameters or considerable CTA artifacts.

The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic Valve Replacement in Real-World Patients.

PubMed

Bosmans, Johan; Bleiziffer, Sabine; Gerckens, Ulrich; Wenaweser, Peter; Brecker, Stephen; Tamburino, Corrado; Linke, Axel

2015-07-21

Transcatheter aortic valve replacement (TAVR) enables treatment of high-risk patients with symptomatic aortic stenosis without open-heart surgery; however, the benefits are mitigated by the potential for neurological events. This study sought to determine the timing and causes of clinically relevant neurological events after self-expandable TAVR. We enrolled 1,015 patients, of whom 996 underwent TAVR with a self-expandable system at 44 TAVR-experienced centers in Europe, Colombia, and Israel. Neurological events were evaluated for 3 distinct time periods: periprocedural (0 to 1 days post TAVR); early (2 to 30 days); and late (31 to 730 days). In this real-world study, neurological events were first referred to the site neurologist and then reviewed by an independent neurologist. The overall stroke rate was 1.4% through the first day post-procedure, 3.0% at 30 days, and 5.6% at 2 years. There were no significant predictors of periprocedural stroke or stroke/transient ischemic attack (TIA) combined. Significant predictors of early stroke were acute kidney injury (p = 0.03), major vascular complication (p = 0.04), and female sex (p = 0.04). For stroke/TIA combined, prior atrial fibrillation (p = 0.03) and major vascular complication (p = 0.009) were predictive. Coronary artery bypass graft surgery was the only significant predictor of late stroke (p = 0.007) or late stroke/TIA (p = 0.06). Treatment of high-risk patients with aortic stenosis using a self-expandable system was associated with a low stroke rate at short- and long-term follow-up. Multivariable predictors of clinically relevant neurological events differed on the basis of the timing after TAVR. (CoreValve Advance International Post Market Study; NCT01074658). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

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

PubMed

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

2015-03-01

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

Does minimalist transfemoral transcatheter aortic valve replacement produce better survival in patients with severe chronic obstructive pulmonary disease?

PubMed

Condado, Jose F; Haider, Moosa N; Lerakis, Stamatios; Keegan, Patricia; Caughron, Hope; Thourani, Vinod H; Devireddy, Chandan; Leshnower, Bradley; Mavromatis, Kreton; Sarin, Eric L; Stewart, James; Guyton, Robert; Forcillo, Jessica; Patel, Ateet; Simone, Amy; Block, Peter C; Babaliaros, Vasilis

2017-03-01

To compare outcomes after minimalist and standard transfemoral transcatheter aortic valve replacement (TF-TAVR) in patients with severe chronic obstructive pulmonary disease (COPD). TF-TAVR is increasingly performed with conscious sedation and transthoracic echocardiography guidance (minimalist). The safety/efficacy of this technique in patients with severe COPD is unknown. We compared demographics, 30-day outcomes and 1-year survival of patients with severe COPD (FEV1% ≤50) who underwent minimalist vs. standard TF-TAVR between 2008 and 2015 at our institution. Of 88 patients with severe COPD, 46 underwent minimalist and 42 underwent standard TF-TAVR. There were no differences on baseline characteristics, except for more history of coronary artery bypass grafting (45.5% vs. 20.6%, P = 0.03) and less history of cerebrovascular disease (16.7% vs. 45.5%, P = 0.03) in the standard TF-TAVR. Seventeen minimalist TF-TAVR patients (41.0%) were transferred directly to the general medical ward with telemetry monitoring (without ICU stay); all standard TF-TAVR patients went to the ICU. Minimalist TF-TAVR patients had shorter procedure time (97 vs. 129 min, P < 0.001), ICU time (21.8 vs. 29.8 hr, P = 0.001) and length of stay (2 vs. 5 days, P = 0.001). There were no differences in procedure complications and 30-day mortality between groups. In our multivariate analysis, minimalist TF-TAVR (HR 0.28, 95%CI 0.08-0.97) and previous coronary revascularization (HR 0.24, 95%CI 0.09-0.65) were associated with increased 1-year survival. In contrast, moderate paravalvular leak (HR 7.73, 95%CI 1.94-30.84) was associated with decreased 1-year survival. In patients with severe COPD, Minimalist TF-TAVR results in less resource utilization and improved 1-year survival compared to standard approach. Our findings should be validated in a larger cohort of patients with severe COPD. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

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

PubMed

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

2017-12-11

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

Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Significantly Reduces Death and Stroke Compared With Unprotected Procedures.

PubMed

Seeger, Julia; Gonska, Birgid; Otto, Markus; Rottbauer, Wolfgang; Wöhrle, Jochen

2017-11-27

The aim of this study was to evaluate the impact of cerebral embolic protection on stroke-free survival in patients undergoing transcatheter aortic valve replacement (TAVR). Imaging data on cerebral embolic protection devices have demonstrated a significant reduction in number and volume of cerebral lesions. A total of 802 consecutive patients were enrolled. The Sentinel cerebral embolic protection device (Claret Medical Inc., Santa Rosa, California) was used in 34.9% (n = 280) of consecutive patients. In 65.1% (n = 522) of patients TAVR was performed in the identical setting except without cerebral embolic protection. Neurological follow-up was done within 7 days post-procedure. The primary endpoint was a composite of all-cause mortality or all-stroke according to Valve Academic Research Consortium-2 criteria within 7 days. Propensity score matching was performed to account for possible confounders. Both filters of the device were successfully positioned in 280 of 305 (91.8%) consecutive patients. With use of cerebral embolic protection rate of disabling and nondisabling stroke was significantly reduced from 4.6% to 1.4% (p = 0.03; odds ratio: 0.29, 95% confidence interval: 0.10 to 0.93) in the propensity-matched population (n = 560). The primary endpoint occurred significantly less frequently, with 2.1% (n = 6 of 280) in the protected group compared with 6.8% (n = 19 of 280) in the control group (p = 0.01; odds ratio: 0.30; 95% confidence interval: 0.12 to 0.77). In multivariable analysis Society of Thoracic Surgeons score for mortality (p = 0.02) and TAVR without protection (p = 0.02) were independent predictors for the primary endpoint. In patients undergoing TAVR use of a cerebral embolic protection device demonstrated a significant higher rate of stroke-free survival compared with unprotected TAVR. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2017-07-25

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

Clinical Impact of Diabetes Mellitus on Outcomes After Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

PubMed

Abramowitz, Yigal; Vemulapalli, Sreekanth; Chakravarty, Tarun; Li, Zhuokai; Kapadia, Samir; Holmes, David; Matsouaka, Roland A; Wang, Alice; Cheng, Wen; Forrester, James S; Smalling, Richard; Thourani, Vinod; Mack, Michael; Leon, Martin; Makkar, Raj R

2017-11-01

Diabetes mellitus (DM) adversely affects morbidity and mortality for cardiovascular diseases and procedures. Data evaluating the outcomes of transcatheter aortic valve replacement (TAVR) in diabetic patients are limited by small sample size and contradictory results. We aimed to establish the magnitude of risk and the incremental influence of insulin dependency by examining short- and long-term adverse outcomes according to DM status and therapy in the world's largest TAVR registry. We analyzed data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. In-hospital mortality, 30-day mortality, and 1-year mortality after TAVR in patients with and without DM were evaluated using multivariate modeling. Among 47 643 patients treated with TAVR from November 2011 through September 2015 at 394 US hospitals, there were 17 849 (37.5%) patients with DM. Overall, 6600 of the diabetic patients were insulin treated (IT). Thirty-day mortality was 5.0% in patients with DM (6.1% in IT DM and 4.4% in non-IT DM; P <0.001) versus 5.9% in patients without DM ( P <0.001). Overall, 1-year mortality was 21.8% in patients with DM (24.8% in IT DM and 20.1% in non-IT DM; P <0.001) versus 21.2% in patients without DM ( P =0.274). In a multivariable model, DM was associated with increased 1-year mortality (hazard ratio, 1.30; 95% confidence interval, 1.13-1.49; P <0.001). Subgroup multivariable analysis showed stronger mortality association in IT diabetics (hazard ratio, 1.57; 95% confidence interval, 1.28-1.91; P <0.001) than in non-IT diabetics (hazard ratio, 1.17; 95% confidence interval, 1.00-1.38; P =0.052). Our data establish the magnitude of short- and long-term risk conferred by DM and the incremental risk conferred by insulin dependency in the performance of TAVR. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01737528. © 2017 American Heart Association, Inc.

Impact of Antithrombotic Regimen on Mortality, Ischemic, and Bleeding Outcomes after Transcatheter Aortic Valve Replacement.

PubMed

Varshney, Anubodh; Watson, Ryan A; Noll, Andrew; Im, KyungAh; Rossi, Jeffrey; Shah, Pinak; Giugliano, Robert P

2018-05-19

Optimal antithrombotic therapy after transcatheter aortic valve replacement (TAVR) remains unclear. We evaluated the association between antithrombotic regimens and outcomes in TAVR patients. We retrospectively analyzed consecutive patients who underwent TAVR at a single academic center from April 2009 to March 2014. Antithrombotic regimens were classified as single or dual antiplatelet therapy (AP), single antiplatelet plus anticoagulant (SAC), or triple therapy (TT). The primary endpoint was a composite of death, myocardial infarction (MI), stroke, and major bleeding. Adjusted hazard ratios (HRs) were obtained with best subset variable selection methods using bootstrap resampling. Of 246 patients who underwent TAVR, 241 were eligible for analysis with 133, 88, and 20 patients in the AP, SAC, and TT groups, respectively. During a median 2.1-year follow-up, 53.5% had at least one endpoint-the most common was death (68%), followed by major bleeding (23%), stroke (6%), and MI (3%). At 2 years, the composite outcome occurred in 70% of TT, 42% of SAC, and 31% of AP patients. Compared to AP, adjusted HRs for the composite outcome were 2.88 [95% Confidence intervals (CI) (1.61-5.16); p = 0.0004] and 1.66 (95% CI [1.13-2.42]; p = 0.009) in the TT and SAC groups, respectively. Mortality rates at 2 years were 61% in the TT, 32% in the SAC, and 26% in the AP groups (p = 0.005). The risk of the composite outcome of death, MI, stroke, or major bleeding at 2-year follow-up was significantly higher in TAVR patients treated with TT or SAC versus AP, even after multivariate adjustment.

Does the disparity in baseline characteristics of patients undergoing transcatheter aortic valve replacement with 23 mm vs. 26 mm valves impact clinical outcome?

PubMed

Escárcega, Ricardo O; Magalhaes, Marco A; Baker, Nevin C; Lipinski, Michael J; Minha, Sa'ar; Torguson, Rebecca; Chen, Fang; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

2016-01-01

We sought to identify if baseline characteristic differences in patients who receive a 23 mm vs. 26 mm valve impact clinical outcomes. Transcatheter aortic valve replacement (TAVR) is currently an approved therapy for patients with severe aortic stenosis who are considered inoperable or are at high risk. We retrospectively examined baseline characteristics and outcomes of patients receiving a 23 mm (n = 132) vs. 26 mm valve (n = 81) via the transfemoral approach. Gender (P < 0.01), previous coronary artery bypass surgery (P < 0.01), history of atrial fibrillation (P = 0.04), and mean Society of Thoracic Surgeons (STS) score (P < 0.01) were significantly different between groups. There were no significant differences in the rates of minor/major vascular complications (2.2 vs. 3.7%, P = 0.68 and 13.0 vs. 12.3%, P = 0.89, respectively). Bleeding complications were also comparable (major bleed 2.3 vs. 1%, P >0.99, minor bleed 19.0 vs. 22.0%, P = 0.67 and life threatening bleed 7.0 vs. 5.0%, P = 0.77). In-hospital death (6.0 vs. 5.0%, P >0.99), 30-day all-cause death (7.6 vs. 6.2%, P = 0.69), and all-cause death at 1 year (17.4 vs. 25.9%, P = 0.13) were also similar between groups. Gender, valve size, previous coronary bypass surgery and atrial fibrillation were not independently associated with mortality; however, on multivariate analysis STS score was (HR 1.11; 95% CI 1.02-1.19; P = 0.01). Patients undergoing TAVR with 23 and 26 mm valves have similar clinical outcomes despite significant differences in baseline characteristics. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Initial findings using the V8 hourglass-shaped valvuloplasty balloon for postdilatation in treating paravalvular leaks associated with transcatheter self-expanding aortic valve prosthesis.

PubMed

Latib, Azeem; Pedersen, Wesley; Maisano, Francesco; Lesser, John; Ruparelia, Neil; Figini, Filippo; Colombo, Antonio; Poulose, Anil; Kolbeck, James; Mooney, Michael; Schwartz, Robert; Youssef, Alicia; Ungs, David; Goldenberg, Irv; Sorajja, Paul

2016-06-01

The aim of this study was to assess the effect of a novel hourglass-shaped balloon on reduction of paravalvular leak (PVL) in patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding prostheses. An important limitation of TAVR compared with surgical aortic valve replacement remains the higher incidence of PVL. A commonly used strategy to treat PVL is balloon postdilatation (BPD); however, the optimal technique for treating PVL after TAVR is unknown. We examined consecutive patients with severe, symptomatic aortic stenosis who underwent TAVR with the Medtronic CoreValve followed by BPD with an InterValve V8 balloon for PVL grade ≥2+. Data from echocardiographic, multidetector computed tomographic, and angiographic images were reviewed. The primary endpoint was successful reduction in PVL to grade 1+ or less as assessed by intraprocedural echocardiography. Eleven patients were studied (median age, 82 years; 64% female). Ten patients (91%) demonstrated successful reduction in PVL after V8 BPD. In three patients, PVL was reduced to zero or trace. PVL remained unchanged in one patient (2+). Two patients had complete heart block associated with valve deployment and received permanent pacemakers. There were no occurrences of annular injury or major adverse clinical events. BPD with the V8 hourglass-shaped balloon was feasible in reducing PVL from self-expanding TAVR prostheses. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Safety of shorter length of hospital stay for patients undergoing minimalist transcatheter aortic valve replacement.

PubMed

Alkhalil, Ahmad; Lamba, Harveen; Deo, Salil; Bezerra, Hiram G; Patel, Sandeep M; Markowitz, Alan; Simon, Daniel I; Costa, Marco A; Davis, Angela C; Attizzani, Guilherme F

2018-02-01

Determine the feasibility and predictors of early discharge after minimalist transcatheter aortic valve replacement (TAVR). Duration of hospitalization has a direct impact on overall cost of care, but the clinical impact of length of stay (LOS) in patients undergoing minimalist TAVR remains unclear. We studied 268 patients who underwent minimalist TAVR. Short LOS (sLOS) was defined as post-procedural LOS ≤ 3 days and observed in 163 patients. Prolonged LOS (pLOS) was observed in 105 patients. Propensity score matching based on 39 variables yielded 54 pairs of patients in each group. We analyzed 30-day mortality, 30-day re-hospitalization and long-term survival data. Multivariate regression models were used to define predictors of sLOS. Thirty-day mortality was 0% versus 5.5% in the sLOS and pLOS groups, respectively (P = 0.08). Incidence of re-hospitalization was higher in pLOS (13% vs. 3.7%). sLOS was associated with lower odds ratio of minor vascular complication (OR 0.1 [95% CI: 0.01, 0.75], P = 0.05), any bleeding (OR 0.35 [95% CI: 0.14, 0.87], P = 0.02), blood transfusion (OR 0.27 [95% CI: 0.08, 0.81], P = 0.02), and new pacemaker implantation (OR 0.23 [95% CI: 0.1, 0.53], P < 0.001). Discharge to home had a significantly higher odd ratio for sLOS (OR 8.67 [95% CI: 3.59, 23.11], P < 0.001). In appropriately selected patients, sLOS following minimalist TAVR approach in an experienced and high volume center is feasible and safe. Implementing such a strategy may reduce medical costs with the potential clinical benefit of early re-habilitation for the elderly TAVR population. © 2017 Wiley Periodicals, Inc.

The Prognostic Effects of Coronary Disease Severity and Completeness of Revascularization on Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement.

PubMed

Witberg, Guy; Regev, Ehud; Chen, Shmuel; Assali, Abbid; Barbash, Israel M; Planer, David; Vaknin-Assa, Hana; Guetta, Victor; Vukasinovic, Vojislav; Orvin, Katia; Danenberg, Haim D; Segev, Amit; Kornowski, Ran

2017-07-24

The study sought to examine the effect of coronary artery disease (CAD) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR). CAD is common in the TAVR population. However, there are conflicting data on the prognostic significance of CAD and its treatment in this population. The authors analyzed 1,270 consecutive patients with severe aortic stenosis (AS) undergoing TAVR at 3 Israeli centers. They investigated the association of CAD severity (no CAD, nonsevere CAD [i.e., SYNTAX score (SS) <22], severe CAD [SS >22]) and revascularization completeness ("reasonable" incomplete revascularization [ICR] [i.e., residual SS <8]; ICR [residual SS >8]) with all-cause mortality following TAVR using a Cox proportional hazards ratio model adjusted for multiple prognostic variables. Of the 1,270 patients, 817 (64%) had no CAD, 331 (26%) had nonsevere CAD, and 122 (10%) had severe CAD. Over a median follow-up of 1.9 years, 311 (24.5%) patients died. Mortality was higher in the severe CAD and the ICR groups, but not in the nonsevere CAD or "reasonable" ICR groups, versus no CAD. After multivariate adjustment, both severe CAD (hazard ratio: 2.091; p = 0.017) and ICR (hazard ratio: 1.720; p = 0.031) were associated with increased mortality. Only severe CAD was associated with increased mortality post-TAVR. More complete revascularization pre-TAVR may attenuate the association of severe CAD and mortality. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2014-08-01

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

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

PubMed

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

2018-04-01

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

Acute Kidney Injury With the RenalGuard System in Patients Undergoing Transcatheter Aortic Valve Replacement: The PROTECT-TAVI Trial (PROphylactic effecT of furosEmide-induCed diuresis with matched isotonic intravenous hydraTion in Transcatheter Aortic Valve Implantation).

PubMed

Barbanti, Marco; Gulino, Simona; Capranzano, Piera; Immè, Sebastiano; Sgroi, Carmelo; Tamburino, Claudia; Ohno, Yohei; Attizzani, Guilherme F; Patanè, Martina; Sicuso, Rita; Pilato, Gerlando; Di Landro, Alessio; Todaro, Denise; Di Simone, Emanuela; Picci, Andrea; Giannetto, Giuliana; Costa, Giuliano; Deste, Wanda; Giannazzo, Daniela; Grasso, Carmelo; Capodanno, Davide; Tamburino, Corrado

2015-10-01

The purpose of this study was to investigate the effect of the RenalGuard System (PLC Medical Systems, Milford, Massachusetts) on prevention of acute kidney injury (AKI) in patients undergoing transcatheter aortic valve replacement (TAVR). TAVR is associated with varying degrees of post-procedural AKI. The RenalGuard System is a dedicated device designed for contrast-induced AKI prevention. Whether this device is also effective in patients with severe aortic stenosis undergoing TAVR is unexplored. The present is an investigator-driven, single-center, prospective, open-label, registry-based randomized study that used the TAVR institutional registry of the Ferrarotto Hospital in Catania, Italy, as the platform for randomization, data collection, and follow-up assessment. A total of 112 consecutive patients undergoing TAVR were randomly assigned to hydration with normal saline solution controlled by the RenalGuard system and furosemide (RenalGuard group) or normal saline solution (control group). The primary endpoint was the incidence of Valve Academic Research Consortium-defined AKI in the first 72 h after the procedure. The AKI rate was lower in the RenalGuard group than in the control group (n = 3 [5.4%] vs. n =14 [25.0%], respectively, p = 0.014). The majority of patients (5.4% vs. 23.2%) developed a mild AKI (stage 1); severe damage (stage 3) occurred only in 1 patient in the control group (0.0% vs. 1.8%). No case of in-hospital renal failure requiring dialysis was reported. No significant differences in terms of mortality, cerebrovascular events, bleeding, and hospitalization for heart failure were noted in both groups at 30 days. Furosemide-induced diuresis with matched isotonic intravenous hydration using the RenalGuard system is an effective therapeutic tool to reduce the occurrence of AKI in patients undergoing TAVR. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

Association of Patient-Reported Health Status with Long-Term Mortality after Transcatheter Aortic Valve Replacement: A Report from the STS/ACC TVT Registry™

PubMed Central

Arnold, Suzanne V.; Spertus, John A.; Vemulapalli, Sreekanth; Dai, Dadi; O’Brien, Sean M.; Baron, Suzanne J.; Kirtane, Ajay J.; Mack, Michael J.; Green, Philip; Reynolds, Matthew R.; Rumsfeld, John S.; Cohen, David J.

2015-01-01

Background Although transcatheter aortic valve replacement (TAVR) is an effective treatment for aortic stenosis, long-term mortality after TAVR remains high and challenging to predict. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a health status measure, assessed directly from patients, that integrates two clinically relevant factors (symptoms and functional status) that may predict TAVR outcomes. Methods and Results Among 7769 patients from 286 sites in the STS-ACC TVT Registry, we examined the association between pre-procedure (baseline) patient health status, as assessed by the KCCQ, and 1-year mortality after TAVR. The KCCQ Overall Summary Score was categorized as very poor: <25, poor: 25–49, fair: 50–74, or good: ≥75. Prior to TAVR, health status was rated as very poor in 28%, poor in 38%, fair in 24%, and good in 10%. Patients with worse health status were more likely to be female and had more comorbidities and higher STS mortality risk scores. Compared with those with good health status prior to TAVR, and after adjusting for a broad range of baseline covariates, patients with very poor health status had a 2-fold increased hazard of death over the first year after TAVR (adjusted HR 2.00, 95% CI 1.58–2.54), while those with poor and fair health status had intermediate outcomes (adjusted HRs 1.54, 95% CI 1.22–1.95 and 1.20, 95% CI 0.94–1.55, respectively). Conclusions In a national, contemporary practice cohort, worse pre-procedure patient health status, as assessed by the KCCQ, was associated with greater long-term mortality after TAVR. These results support the measurement and integration of the KCCQ into mortality risk assessments for patients considering TAVR. PMID:26643740

Echocardiographic parameters predicting acute hemodynamically significant mitral regurgitation during transfemoral transcatheter aortic valve replacement.

PubMed

Ito, Asahiro; Iwata, Shinichi; Mizutani, Kazuki; Nonin, Shinichi; Nishimura, Shinsuke; Takahashi, Yosuke; Yamada, Tokuhiro; Murakami, Takashi; Shibata, Toshihiko; Yoshiyama, Minoru

2018-03-01

Alteration in mitral valve morphology resulting from retrograde stiff wire entanglement sometimes causes hemodynamically significant acute mitral regurgitation (MR) during transfemoral transcatheter aortic valve replacement (TAVR). Little is known about the echocardiographic parameters related to hemodynamically significant acute MR. This study population consisted of 64 consecutive patients who underwent transfemoral TAVR. We defined hemodynamically significant acute MR as changes in the severity of MR with persistent hypotension (systolic blood pressure < 80-90 mm Hg or mean arterial pressure 30 mm Hg lower than baseline). Hemodynamically significant acute MR occurred in 5 cases (7.8%). Smaller left ventricular end-systolic diameter (LVDs), larger ratios of the coiled section of stiff wire tip to LVDs (wire-width/LVDs), and higher Wilkins score were significantly associated with hemodynamically significant acute MR (P < .05), whereas the parameters of functional MR (annular area, anterior-posterior diameter, tenting area, and coaptation length) were not. Moreover, when patients were divided into 4 groups according to wire-width/LVDs and Wilkins score, the group with the larger wire-width/LVDs and higher Wilkins score improved prediction rates (P < .05). Small left ventricle or wire oversizing and calcific mitral apparatus were predictive of hemodynamically significant acute MR. These findings are important for risk stratification, and careful monitoring using intraoperative transesophageal echocardiography may improve the safety in this population. © 2017, Wiley Periodicals, Inc.

Comparison of local versus general anesthesia in patients undergoing transcatheter aortic valve replacement: A meta-analysis.

PubMed

Villablanca, Pedro A; Mohananey, Divyanshu; Nikolic, Katarina; Bangalore, Sripal; Slovut, David P; Mathew, Verghese; Thourani, Vinod H; Rode's-Cabau, Josep; Núñez-Gil, Iván J; Shah, Tina; Gupta, Tanush; Briceno, David F; Garcia, Mario J; Gutsche, Jacob T; Augoustides, John G; Ramakrishna, Harish

2018-02-01

Transcatheter aortic valve replacement (TAVR) is typically performed under general anesthesia (GA). However, there is increasing data supporting the safety of performing TAVR under local anesthesia/conscious sedation (LA). We performed a meta-analysis to gain better understanding of the safety and efficacy of LA versus GA in patients with severe aortic stenosis undergoing TAVR. We comprehensively searched EMBASE, PubMed, and Web of Science. Effect sizes were summarized using risk ratios (RRs) difference of the mean (DM), and 95% CIs (confidence intervals) for dichotomous and continuous variables respectively. Twenty-six studies and 10,572 patients were included in the meta-analysis. The use of LA for TAVR was associated with lower overall 30-day mortality (RR, 0.73; 95% CI, 0.57-0.93; P = 0.01), use of inotropic/vasopressor drugs (RR, 0.45; 95% CI, 0.28-0.72; P < 0.001), hospital length of stay (LOS) (DM, -2.09; 95% CI, -3.02 to -1.16; P < 0.001), intensive care unit LOS (DM, -0.18; 95% CI, -0.31 to -0.04; P = 0.01), procedure time (DM, -25.02; 95% CI, -32.70 to -17.35; P < 0.001); and fluoroscopy time (DM, -1.63; 95% CI, -3.02 to -0.24; P = 0.02). No differences were observed between LA and GA for stroke, cardiovascular mortality, myocardial infarction, permanent pacemaker implantation, acute kidney injury, paravalvular leak, vascular complications, major bleeding, procedural success, conduction abnormalities, and annular rupture. Our meta-analysis suggests that use of LA for TAVR is associated with a lower 30-day mortality, shorter procedure time, fluoroscopy time, ICU LOS, hospital length of stay, and reduced need for inotropic support. © 2017 Wiley Periodicals, Inc.

Evolution and prognostic impact of low flow after transcatheter aortic valve replacement.

PubMed

Le Ven, Florent; Thébault, Christophe; Dahou, Abdellaziz; Ribeiro, Henrique B; Capoulade, Romain; Mahjoub, Haïfa; Urena, Marina; Nombela-Franco, Luis; Allende Carrera, Ricardo; Clavel, Marie-Annick; Dumont, Éric; Dumesnil, Jean; De Larochellière, Robert; Rodés-Cabau, Josep; Pibarot, Philippe

2015-08-01

Low flow (LF), defined as stroke volume index (SVi) <35 mL/m(2), prior to the procedure has been recently identified as a powerful independent predictor of early and late mortality in patients undergoing transcatheter aortic valve replacement (TAVR). The objectives of this study were to determine the evolution of SVi following TAVR and to assess the determinants and impact on mortality of early postprocedural SVi (EP-SVi). We retrospectively analysed the clinical, Doppler echocardiographic and outcome data prospectively collected in 255 patients who underwent TAVR. Echocardiograms were performed before (baseline), within 5 days after procedure (early post procedure) and 6 months to 1 year following TAVR (late post procedure). Patients with EP-SVi <35 mL/m(2) (n=138; 54%) had increased mortality (HR 1.97, p=0.003) compared with those with EP-SVi ≥35 mL/m(2) (n=117; 46%). Furthermore, patients with baseline SVi (B-SVi) <35 mL/m(2) and EP-SVI ≥35 mL/m(2), that is, normalised flow, had better survival (HR 0.46, p=0.03) than those with both B-SVi and EP-SVi <35 mL/m(2), that is, persistent LF, and similar survival compared with those with both B-SVi and EP-SVi ≥35 mL/m(2), that is, maintained normal flow. In a multivariable model analysis, EP-SVi was independently associated with increased risk of mortality (HR 1.41 per 10 mL/m(2) decrease, p=0.03). The preprocedural/intraprocedural factors associated with lower EP-SVi were lower B-SVi (standardised β [β] 0.36, p<0.001) atrial fibrillation (β -0.13, p=0.02) and transapical approach (β -0.22, p<0.001). The measurement of EP-SVi is useful to assess the immediate haemodynamic benefit of TAVR and to predict the risk of late mortality. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The incidence and prognostic implications of worsening right ventricular function after surgical or transcatheter aortic valve replacement: insights from PARTNER IIA.

PubMed

Cremer, Paul C; Zhang, Yiran; Alu, Maria; Rodriguez, L Leonardo; Lindman, Brian R; Zajarias, Alan; Hahn, Rebecca T; Lerakis, Stamatios; Malaisrie, S Chris; Douglas, Pamela S; Pibarot, Philippe; Svensson, Lars G; Leon, Martin B; Jaber, Wael A

2018-05-08

In patients randomized to transcatheter or surgical aortic valve replacement (TAVR, SAVR), we sought to determine whether SAVR is associated with worsening right ventricular (RV) function and whether RV deterioration is associated with mortality. In 1376 patients from PARTNERIIA with paired baseline and 30-day core lab echocardiograms, worsening RV function was defined as decline by at least one grade from baseline to 30 days. Our primary outcome was all-cause mortality from 30 days to 2 years. Among 744 patients with TAVR, 62 (8.3%) had worsening RV function, compared with 156 of 632 patients with SAVR (24.7%) (P < 0.0001). In a multivariable model, SAVR [odds ratio (OR) 4.05, 95% confidence interval (CI) 2.55-6.44], a dilated RV (OR 2.38, 95% CI 1.37-4.14), and more than mild tricuspid regurgitation (TR) (OR 2.58, 95% CI 1.25-5.33) were associated with worsening RV function. There were 169 deaths, and patients with worsening RV function had higher all-cause mortality [hazard ratio (HR) 1.98, 95% CI 1.40-2.79]. This association remained robust after adjusting for clinical and echocardiographic variables. Among patients with worsening RV function, there was no mortality difference between TAVR and SAVR (HR 1.16, 95% CI 0.61-2.18). The development of moderate or severe RV dysfunction from baseline normal RV function conferred the worst prognosis (HR 2.87, 95% CI 1.40-5.89). After aortic valve replacement, worsening RV function is more common in patients with baseline RV dilation, more than mild TR, and in patients treated with SAVR. Worsening RV function and the magnitude of deterioration have important prognostic implications.

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.

Importance of Geriatric Nutritional Risk Index assessment in patients undergoing transcatheter aortic valve replacement.

PubMed

Shibata, Kenichi; Yamamoto, Masanori; Kano, Seiji; Koyama, Yutaka; Shimura, Tetsuro; Kagase, Ai; Yamada, Sumio; Kobayashi, Toshihiro; Tada, Norio; Naganuma, Toru; Araki, Motoharu; Yamanaka, Futoshi; Shirai, Shinichi; Mizutani, Kazuki; Tabata, Minoru; Ueno, Hiroshi; Takagi, Kensuke; Higashimori, Akihiro; Watanabe, Yusuke; Otsuka, Toshiaki; Hayashida, Kentaro

2018-05-15

Nutritional condition is one marker of patients' frailty. The Geriatric Nutritional Risk Index (GNRI) is a well-known marker of nutritional status. This study sought to assess the clinical outcomes of GNRI after transcatheter aortic valve replacement (TAVR). We evaluated the GNRI value of 1,613 patients who underwent TAVR using data from a Japanese multicenter registry. According to baseline GNRI, patients were classified into 3 groups: GNRI ≥92 (n = 1,085; 67.3%), GNRI 82-92 (n = 396; 24.6%), and GNRI ≤82 (n = 132; 8.2%). Baseline characteristics, procedural outcomes, and cumulative mortality rates were compared. In addition, GNRI correlations with other frailty components (gait speed, grip strength, and Clinical Frailty Scale) and Society of Thoracic Surgeons (STS) score were also evaluated. Significantly increased mortality rates were observed across the 3 groups at 30 days (0.9%, 2.3%, and 6.8%, respectively; P < .001) and 1 year (6.5%, 16.4%, and 36.4%, respectively; P < .001). Both GNRI 82-92 and GNRI ≤82 (as a reference for GNRI ≥92) were independently associated with increased midterm mortality in the Cox regression multivariate model (hazard ratio: 1.97, 3.60; 95% confidence interval: 1.37-2.84, 2.30-5.64; P < .001, P < .001, respectively). The GNRI value was significantly correlated with gait speed (Spearman ρ = -0.15, P < .001), grip strength (ρ = 0.25, P < .001), Clinical Frailty Scale (ρ = -0.24, P < .001), and STS score (ρ = -0.29, P < .001). GNRI is related to both frailty components and the STS score and is an important surrogate marker for predicting worse clinical outcomes after TAVR. Assessment of the GNRI may be considered when deciding on TAVR. Copyright © 2018. Published by Elsevier Inc.

Transcatheter Aortic Valve Replacement for Native Aortic Valve Regurgitation

PubMed Central

Spina, Roberto; Anthony, Chris; Muller, David WM

2015-01-01

Transcatheter aortic valve replacement with either the balloon-expandable Edwards SAPIEN XT valve, or the self-expandable CoreValve prosthesis has become the established therapeutic modality for severe aortic valve stenosis in patients who are not deemed suitable for surgical intervention due to excessively high operative risk. Native aortic valve regurgitation, defined as primary aortic incompetence not associated with aortic stenosis or failed valve replacement, on the other hand, is still considered a relative contraindication for transcatheter aortic valve therapies, because of the absence of annular or leaflet calcification required for secure anchoring of the transcatheter heart valve. In addition, severe aortic regurgitation often coexists with aortic root or ascending aorta dilatation, the treatment of which mandates operative intervention. For these reasons, transcatheter aortic valve replacement has been only sporadically used to treat pure aortic incompetence, typically on a compassionate basis and in surgically inoperable patients. More recently, however, transcatheter aortic valve replacement for native aortic valve regurgitation has been trialled with newer-generation heart valves, with encouraging results, and new ancillary devices have emerged that are designed to stabilize the annulus–root complex. In this paper we review the clinical context, technical characteristics and outcomes associated with transcatheter treatment of native aortic valve regurgitation. PMID:29588674

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

PubMed

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

2015-08-24

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

Mechanical valve replacement in congenital heart disease.

PubMed

Fiane, A E; Lindberg, H L; Saatvedt, K; Svennevig, J L

1996-05-01

Mechanical valves are the prosthesis of choice in valve replacement in children. However, the problem of somatic growth leading to patient-valve mismatch remains present, and the appropriate anticoagulation regimen remains controversial. We present our experience of valve replacement in a young population over 20 years. Between 1972 and 1992, 48 patients (34 males and 14 females), mean age 11.2 years (range 0.4-27.4 years), underwent mechanical valve replacement at our institution. Aortic valve replacement was performed in 28 patients (58.3%), mitral valve replacement in 13 (27.1%), tricuspid valve replacement in six (12.5%) and pulmonary valve replacement in one patient (2.1%). The prostheses used were: St. Jude Medical (n = 2), Björk-Shiley (n = 14), Medtronic Hall (n = 16), Duromedics (n = 2) and CarboMedics (n = 14). Early mortality was 14.3%, 10.7% for aortic valve replacement and 30.8% for mitral valve replacement. Mean follow up for all patients was 8.3 years (range 0-22 years), with a total of 398 patient-years. Seven patients died during the follow up (17.1%). Survival after 10 years, including operative mortality, was 81% for aortic valve replacement, 33% for mitral valve replacement, 83% for tricuspid valve replacement and 100% for pulmonary valve replacement. All patients were anticoagulated with warfarin. In eight patients (16.7%) an antiplatelet drug (aspirin or dipyridamole) was added. Major events included paravalvular leak in six patients (1.5%/pty), valve thrombosis in five (mitral position in two, tricuspid in three) (1.3%/pty) and endocarditis in one patient (0.3%/pty). Minor thromboembolic events occurred in three patients (0.8%/pty) and minor hemorrhagic events in three (0.8%/pty). No patients developed hemolytic anemia and there was no case of structural failure. In our experience, mechanical prostheses in congenital heart disease were associated with significant morbidity and mortality, however long term survival after aortic valve

The association between renal recovery after acute kidney injury and long-term mortality after transcatheter aortic valve replacement.

PubMed

Thongprayoon, Charat; Cheungpasitporn, Wisit; Srivali, Narat; Kittanamongkolchai, Wonngarm; Sakhuja, Ankit; Greason, Kevin L; Kashani, Kianoush B

2017-01-01

This study aimed to examine the association between renal recovery status at hospital discharge after acute kidney injury (AKI) and long-term mortality following transcatheter aortic valve replacement (TAVR). We screened all adult patients who survived to hospital discharge after TAVR for aortic stenosis at a quaternary referral medical center from January 1, 2008, through June 30, 2014. An AKI was defined as an increase in serum creatinine level of 0.3 mg/dL or a relative increase of 50% from baseline. Renal outcome at the time of discharge was evaluated by comparing the discharge serum creatinine level to the baseline level. Complete renal recovery was defined as no AKI at discharge, whereas partial renal recovery was defined as AKI without a need for renal replacement therapy at discharge. No renal recovery was defined as a need for renal replacement therapy at discharge. The study included 374 patients. Ninty-eight (26%) patients developed AKI during hospitalization: 55 (56%) had complete recovery; 39 (40%), partial recovery; and 4 (4%), no recovery. AKI development was significantly associated with increased risk of 2-year mortality (hazard ratio [HR], 2.20 [95% CI, 1.37-3.49]). For patients with AKI, the 2-year mortality rate for complete recovery was 34%; for partial recovery, 43%; and for no recovery, 75%; compared with 20% for patients without AKI (P < .001). In adjusted analysis, complete recovery (HR, 1.87 [95% CI, 1.03-3.23]); partial recovery (HR, 2.65 [95% CI, 1.40-4.71]) and no recovery (HR, 10.95 [95% CI, 2.59-31.49]) after AKI vs no AKI were significantly associated with increased risk of 2-year mortality. The mortality rate increased for all patients with AKI undergoing TAVR. A reverse correlation existed for progressively higher risk of death and the extent of AKI recovery.

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

Conduction Abnormalities and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Device: The United Kingdom Experience.

PubMed

Rampat, Rajiv; Khawaja, M Zeeshan; Hilling-Smith, Roland; Byrne, Jonathan; MacCarthy, Philip; Blackman, Daniel J; Krishnamurthy, Arvindra; Gunarathne, Ashan; Kovac, Jan; Banning, Adrian; Kharbanda, Raj; Firoozi, Sami; Brecker, Stephen; Redwood, Simon; Bapat, Vinayak; Mullen, Michael; Aggarwal, Suneil; Manoharan, Ganesh; Spence, Mark S; Khogali, Saib; Dooley, Maureen; Cockburn, James; de Belder, Adam; Trivedi, Uday; Hildick-Smith, David

2017-06-26

The authors report the incidence of pacemaker implantation up to hospital discharge and the factors influencing pacing rate following implantation of the LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts) in the United Kingdom. Transcatheter aortic valve replacement (TAVR) is associated with a significant need for permanent pacemaker implantation. Pacing rates vary according to the device used. The REPRISE II (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System) trial reported a pacing rate of 29% at 30 days after implantation of the LOTUS device. Data were collected retrospectively on 228 patients who had the LOTUS device implanted between March 2013 and February 2015 across 10 centers in the United Kingdom. Twenty-seven patients (12%) had pacemakers implanted pre-procedure and were excluded from the analysis. Patients were aged 81.2 ± 7.7 years; 50.7% were male. The mean pre-procedural QRS duration was 101.7 ± 20.4 ms. More than one-half of the cohort (n = 111, 55%) developed new left bundle branch block (LBBB) following the procedure. Permanent pacemakers were implanted in 64 patients (32%) with a median time to insertion of 3.0 ± 3.4 days. Chief indications for pacing were atrioventricular (AV) block (n = 46, 72%), or LBBB with 1st degree AV block (n = 11, 17%). Amongst those who received a pacemaker following TAVR the pre-procedural electrocardiogram findings included: No conduction disturbance (n = 41, 64%); 1st degree AV block (n = 10, 16%); right bundle branch block (n = 6, 9%) and LBBB (n = 5, 8%). LBBB (but not permanent pacemaker) occurred more frequently in patients who had balloon aortic valvuloplasty before TAVR (odds ratio [OR]: 1.25; p = 0.03). Pre-procedural conduction abnormality (composite of 1st degree AV block, hemiblock, right bundle branch block, LBBB) was independently associated with the need for permanent pacemaker (OR: 2.54; p = 0.048). The absence of

Dual-source CT imaging to plan transcatheter aortic valve replacement: accuracy for diagnosis of obstructive coronary artery disease.

PubMed

Harris, Brett S; De Cecco, Carlo N; Schoepf, U Joseph; Steinberg, Daniel H; Bayer, Richard R; Krazinski, Aleksander W; Dyer, Kevin T; Sandhu, Monique K; Zile, Michael R; Meinel, Felix G

2015-04-01

To assess the accuracy of computed tomographic (CT) examinations performed for the purpose of transcatheter aortic valve replacement (TAVR) planning to diagnose obstructive coronary artery disease (CAD). With institutional review board approval, waivers of informed consent, and in compliance with HIPAA, 100 consecutive TAVR candidates (61 men, mean age 79.6 years ± 9.9) who underwent both TAVR planning CT (with a dual-source CT system) and coronary catheter (CC) angiographic imaging were retrospectively analyzed. At both modalities, the presence of stenosis in the native coronary arteries was assessed. Additionally, all coronary bypass grafts were rated as patent or occluded. With CC angiographic imaging as the reference standard, the accuracy of CT for lesion detection on a per-vessel and per-patient basis was calculated. The accuracy of CT for the assessment of graft patency was also analyzed. For per-vessel and per-patient analysis for the detection of stenosis that was 50% or more in the native coronary arteries, CT imaging had, respectively, 94.4% and 98.6% sensitivity, 68.4% and 55.6% specificity, 94.7% and 93.8% negative predictive value (NPV), and 67.0% and 85.7% positive predictive value. Per-patient sensitivity of stenosis 50% or greater with CT for greater than 70% stenosis at CC angiographic imaging was 100%. All 12 vessels in which percutaneous coronary intervention was performed were correctly identified as demonstrating stenosis 50% or greater with CT. There was agreement between CT and CC angiographic imaging regarding graft patency in 114 of 115 grafts identified with CC angiographic imaging. TAVR planning CT has high sensitivity and NPV in excluding obstructive CAD. An additional preprocedural CC angiographic examination may not be required in TAVR candidates with a CT examination that does not show obstructive CAD. © RSNA, 2014 Online supplemental material is available for this article.

Dual antiplatelet therapy versus single antiplatelet therapy after transaortic valve replacement: Meta-analysis.

PubMed

Alrifai, Abdulah; Soud, Mohamad; Kabach, Amjad; Jobanputra, Yash; Masrani, Abdulrahman; El Dassouki, Saleh; Alraies, M Chadi; Fanari, Zaher

2018-03-16

The current guidelines recommend empirical therapy with DAPT of aspirin and clopidogrel for six months after TAVR. This recommendation is based on expert consensus only. Giving the lack of clear consensus on treatment strategy following TAVR. Goal of this meta-analysis is to assess the efficacy and safety of mono-antiplatelet therapy (MAPT) versus dual antiplatelet therapy (DAPT) following transcatheter aortic valve replacement (TAVR). We performed a meta-analysis from randomized clinical trials (RCTs) and prospective studies that tested DAPT vs. MAPT for all-cause mortality and major bleeding of 603 patients. The primary efficacy outcomes were 30 days mortality and stroke. The primary safety outcomes were major bleeding and major vascular complications. We included 603 patients from 4 studies. The use of MAPT was associated with similar mortality rate (5.9% vs. 6.6%; RR = 0.92; 95% CI 0.49-1.71; P = 0.68) and stroke rate compared with DAPT (1.3% vs. 1.3%; RR 1.04; 95% CI 0.27 to 4.04; P = 0.81). There was no difference in major vascular complication (4.2% vs. 8.9%; RR 0.52; 95% CI 0.23 to 1.18; P = 0.17) or minor vascular complication (4.2% vs. 7.3%; RR 0.58; 95% CI 0.25 to 1.34; P = 0.14). However, MAPT was associated with significantly less risk of major bleeding (4.9% vs. 14.5%; RR 0.37; 95% CI 0.20 to 0.70; P < 0.01) but no difference in minor bleeding (4.2% vs. 3.6%; RR 1.16; 95% CI 0.43 to 3.10; P = 0.85). MAPT use after TAVR is associated with lower rates of major bleeding compared with DAPT with no significant difference in mortality, stroke or vascular complications. Copyright © 2018 Elsevier Inc. All rights reserved.

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Prior Coronary Artery Bypass Grafting: Trends in Utilization and Propensity-Matched Analysis of In-Hospital Outcomes.

PubMed

Gupta, Tanush; Khera, Sahil; Kolte, Dhaval; Goel, Kashish; Kalra, Ankur; Villablanca, Pedro A; Aronow, Herbert D; Abbott, J Dawn; Fonarow, Gregg C; Taub, Cynthia C; Kleiman, Neal S; Weisz, Giora; Inglessis, Ignacio; Elmariah, Sammy; Rihal, Charanjit S; Garcia, Mario J; Bhatt, Deepak L

2018-04-01

A significant proportion of patients requiring aortic valve replacement (AVR) have undergone prior coronary artery bypass grafting (CABG). Reoperative heart surgery is associated with increased risk. Data on relative utilization and comparative outcomes of transcatheter (TAVR) versus surgical AVR (SAVR) in patients with prior CABG are limited. We queried the 2012 to 2014 National Inpatient Sample databases to identify isolated AVR hospitalizations in adults with prior CABG. In-hospital outcomes of TAVR versus SAVR were compared using propensity-matched analysis. Of 147 395 AVRs, 15 055 (10.2%) were in patients with prior CABG. The number of TAVRs in patients with prior CABG increased from 1615 in 2012 to 4400 in 2014, whereas the number of SAVRs decreased from 2285 to 1895 ( P trend <0.001). There were 3880 records in each group in the matched cohort. Compared with SAVR, TAVR was associated with similar in-hospital mortality (2.3% versus 2.4%; P =0.71) but lower incidence of myocardial infarction (1.5% versus 3.4%; P <0.001), stroke (1.4% versus 2.7%; P <0.001), bleeding complications (10.6% versus 24.6%; P <0.001), and acute kidney injury (16.2% versus 19.3%; P <0.001). Requirement for prior permanent pacemaker was higher in the TAVR cohort, whereas the incidence of vascular complications and acute kidney injury requiring dialysis was similar in the 2 groups. Average length of stay was shorter in patients undergoing TAVR. TAVR is being increasingly used as the preferred modality of AVR in patients with prior CABG. Compared with SAVR, TAVR is associated with similar in-hospital mortality but lower rates of in-hospital complications in this important subset of patients. © 2018 American Heart Association, Inc.

Valve Repair or Replacement

MedlinePlus

... called anticoagulants) for the rest of their lives. Biological valves are made from animal tissue (called a ... for valve replacement (called an autograft). Patients with biological valves usually do not need to take blood- ...

Causes of death from the randomized CoreValve US Pivotal High-Risk Trial.

PubMed

Gaudiani, Vincent; Deeb, G Michael; Popma, Jeffrey J; Adams, David H; Gleason, Thomas G; Conte, John V; Zorn, George L; Hermiller, James B; Chetcuti, Stan; Mumtaz, Mubashir; Yakubov, Steven J; Kleiman, Neal S; Huang, Jian; Reardon, Michael J

2017-06-01

Explore causes and timing of death from the CoreValve US Pivotal High-Risk Trial. An independent clinical events committee adjudicated causes of death, followed by post hoc hierarchical classification. Baseline characteristics, early outcomes, and causes of death were evaluated for 3 time periods (selected based on threshold of surgical 30-day mortality and on the differences in the continuous hazard between the 2 groups): early (0-30 days), recovery (31-120 days), and late (121-365 days). Differences in the rate of death were evident only during the recovery period (31-120 days), whereas 15 patients undergoing transcatheter aortic valve replacement (TAVR) (4.0%) and 27 surgical aortic valve replacement (SAVR) patients (7.9%) died (P = .025). This mortality difference was largely driven by higher rates of technical failure, surgical complications, and lack of recovery following surgery. From 0 to 30 days, the causes of death were more technical failures in the TAVR group and lack of recovery in the SAVR group. Mortality in the late period (121-365 days) in both arms was most commonly ascribed to other circumstances, comprising death from medical complications from comorbid disease. Mortality at 1 year in the CoreValve US Pivotal High-Risk Trial favored TAVR over SAVR. The major contributor was that more SAVR patients died during the recovery period (31-121 days), likely affected by the overall influence of physical stress associated with surgery. Similar rates of technical failure and complications were observed between the 2 groups. This suggests that early TAVR results can improve with technical refinements and that high-risk surgical patients will benefit from reducing complications. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

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

Annual Outcomes With Transcatheter Valve Therapy: From the STS/ACC TVT Registry.

PubMed

Holmes, David R; Nishimura, Rick A; Grover, Frederick L; Brindis, Ralph G; Carroll, John D; Edwards, Fred H; Peterson, Eric D; Rumsfeld, John S; Shahian, David M; Thourani, Vinod H; Tuzcu, E Murat; Vemulapalli, Sreekanth; Hewitt, Kathleen; Michaels, Joan; Fitzgerald, Susan; Mack, Michael J

2016-02-01

The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry has been a joint initiative of the STS and the ACC in concert with multiple stakeholders. The TVT Registry has important information regarding patient selection, delivery of care, science, education, and research in the field of structural valvular heart disease. This report provides an overview on current U.S. TVT practice and trends. The emphasis is on demographics, in-hospital procedural characteristics, and outcomes of patients having transcatheter aortic valve replacement (TAVR) performed at 348 U.S. centers. The TVT Registry captured 26,414 TAVR procedures as of December 31, 2014. Temporal trends between 2012 and 2013 versus 2014 were compared. Comparison of the 2 time periods reveals that TAVR patients remain elderly (mean age 82 years), with multiple comorbidities, reflected by a high mean STS predicted risk of mortality (STS PROM) for surgical valve replacement (8.34%), were highly symptomatic (New York Heart Association functional class III/IV in 82.5%), frail (slow 5-m walk test in 81.6%), and have poor self-reported health status (median baseline Kansas City Cardiomyopathy Questionnaire score of 39.1). Procedure performance is changing, with an increased use of moderate sedation (from 1.6% to 5.1%) and increase in femoral access using percutaneous techniques (66.8% in 2014). Vascular complication rates are decreasing (from 5.6% to 4.2%), whereas site-reported stroke rates remain stable at 2.2%. The TVT Registry provides important information on characteristics and outcomes of TAVR in contemporary U.S. clinical practice. It can be used to identify trends in practice and opportunities for quality improvement.

Periprocedural considerations of transcatheter aortic valve implantation for anesthesiologists

PubMed Central

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

2016-01-01

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

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

Impact of New-Onset Left Bundle Branch Block and Periprocedural Permanent Pacemaker Implantation on Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

PubMed

Regueiro, Ander; Abdul-Jawad Altisent, Omar; Del Trigo, María; Campelo-Parada, Francisco; Puri, Rishi; Urena, Marina; Philippon, François; Rodés-Cabau, Josep

2016-05-01

Available data on the clinical impact of new-onset left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) remains controversial. We aimed to evaluate the impact of (1) periprocedural new-onset LBBB or PPI post-TAVR on cardiac mortality and all-cause 1-year mortality and (2) new-onset LBBB on the need for PPI at 1-year follow-up. We performed a systematic search from PubMed and EMBASE databases for studies reporting raw data on new-onset LBBB post-TAVR and the need for PPI or mortality at 1-year follow-up, or on 1-year mortality according to the need for periprocedural PPI post-TAVR. Data from 17 studies, including 4756 patients (8 studies) and 7032 patients (11 studies) for the evaluation of the impact of new-onset LBBB and periprocedural PPI post-TAVR were sourced, respectively (with 2 studies used for both outcomes). New-onset LBBB post-TAVR was associated with a higher risk of PPI (risk ratio [RR], 2.18; 95% confidence interval [CI], 1.28-3.70) and cardiac death (RR, 1.39; 95% CI, 1.04-1.86) during follow-up, as well with a tendency toward an increase in all-cause mortality (RR, 1.21; 95% CI, 0.98-1.50). Periprocedural PPI post-TAVR was not associated with any increased risk of all-cause mortality at 1 year (RR, 1.03; 95% CI, 0.9-1.18), yet a tendency toward a protective effect on cardiac death was observed (RR, 0.78; 95% CI, 0.60-1.03). New-onset LBBB post-TAVR is a marker of an increased risk of cardiac death and need for PPI at 1-year follow-up. The need for PPI early post-TAVR did not increase the risk of death. © 2016 American Heart Association, Inc.

The impact of trans-catheter aortic valve replacement induced left-bundle branch block on cardiac reverse remodeling.

PubMed

Dobson, Laura E; Musa, Tarique A; Uddin, Akhlaque; Fairbairn, Timothy A; Bebb, Owen J; Swoboda, Peter P; Haaf, Philip; Foley, James; Garg, Pankaj; Fent, Graham J; Malkin, Christopher J; Blackman, Daniel J; Plein, Sven; Greenwood, John P

2017-02-22

Left bundle branch block (LBBB) is common following trans-catheter aortic valve replacement (TAVR) and has been linked to increased mortality, although whether this is related to less favourable cardiac reverse remodeling is unclear. The aim of the study was to investigate the impact of TAVR induced LBBB on cardiac reverse remodeling. 48 patients undergoing TAVR for severe aortic stenosis were evaluated. 24 patients with new LBBB (LBBB-T) following TAVR were matched with 24 patients with a narrow post-procedure QRS (nQRS). Patients underwent cardiovascular magnetic resonance (CMR) prior to and 6 m post-TAVR. Measured cardiac reverse remodeling parameters included left ventricular (LV) size, ejection fraction (LVEF) and global longitudinal strain (GLS). Inter- and intra-ventricular dyssynchrony were determined using time to peak radial strain derived from CMR Feature Tracking. In the LBBB-T group there was an increase in QRS duration from 96 ± 14 to 151 ± 12 ms (P < 0.001) leading to inter- and intra-ventricular dyssynchrony (inter: LBBB-T 130 ± 73 vs nQRS 23 ± 86 ms, p < 0.001; intra: LBBB-T 118 ± 103 vs. nQRS 13 ± 106 ms, p = 0.001). Change in indexed LV end-systolic volume (LVESVi), LVEF and GLS was significantly different between the two groups (LVESVi: nQRS -7.9 ± 14.0 vs. LBBB-T -0.6 ± 10.2 ml/m 2 , p = 0.02, LVEF: nQRS +4.6 ± 7.8 vs LBBB-T -2.1 ± 6.9%, p = 0.002; GLS: nQRS -2.1 ± 3.6 vs. LBBB-T +0.2 ± 3.2%, p = 0.024). There was a significant correlation between change in QRS and change in LVEF (r = -0.434, p = 0.002) and between change in QRS and change in GLS (r = 0.462, p = 0.001). Post-procedure QRS duration was an independent predictor of change in LVEF and GLS at 6 months. TAVR-induced LBBB is associated with less favourable cardiac reverse remodeling at medium term follow up. In view of this, every effort should be made to prevent TAVR-induced LBBB

Bivalirudin Versus Heparin Anticoagulation in Transcatheter Aortic Valve Replacement: The Randomized BRAVO-3 Trial.

PubMed

Dangas, George D; Lefèvre, Thierry; Kupatt, Christian; Tchetche, Didier; Schäfer, Ulrich; Dumonteil, Nicolas; Webb, John G; Colombo, Antonio; Windecker, Stephan; Ten Berg, Jurriën M; Hildick-Smith, David; Mehran, Roxana; Boekstegers, Peter; Linke, Axel; Tron, Christophe; Van Belle, Eric; Asgar, Anita W; Fach, Andreas; Jeger, Raban; Sardella, Gennaro; Hink, Hans Ulrich; Husser, Oliver; Grube, Eberhard; Deliargyris, Efthymios N; Lechthaler, Ilknur; Bernstein, Debra; Wijngaard, Peter; Anthopoulos, Prodromos; Hengstenberg, Christian

2015-12-29

Anticoagulation is required during transcatheter aortic valve replacement (TAVR) procedures. Although an optimal regimen has not been determined, heparin is mainly used. Direct thrombin inhibition with bivalirudin may be an effective alternative to heparin as the procedural anticoagulant agent in this setting. The goal of this study was to determine whether bivalirudin offers an alternative to heparin as the procedural anticoagulant agent in patients undergoing TAVR. A total of 802 patients with aortic stenosis were randomized to undergo transfemoral TAVR with bivalirudin versus unfractionated heparin during the procedure. The 2 primary endpoints were major bleeding within 48 h or before hospital discharge (whichever occurred first) and 30-day net adverse clinical events, defined as the combination of major adverse cardiovascular events (all-cause mortality, myocardial infarction, or stroke) and major bleeding. Anticoagulation with bivalirudin versus heparin did not meet superiority because it did not result in significantly lower rates of major bleeding at 48 h (6.9% vs. 9.0%; relative risk: 0.77; 95% confidence interval [CI]: 0.48 to 1.23; p = 0.27) or net adverse cardiovascular events at 30 days (14.4% vs. 16.1%; relative risk: 0.89; 95% CI: 0.64 to 1.24; risk difference: -1.72; 95% CI: -6.70 to 3.25; p = 0.50); regarding the latter, the prespecified noninferiority hypothesis was met (pnoninferiority < 0.01). Rates of major adverse cardiovascular events at 48 h were not significantly different (3.5% vs. 4.8%; relative risk: 0.73; 95% CI: 0.37 to 1.43; p = 0.35). At 48 h, the bivalirudin group had significantly fewer myocardial infarctions but more acute kidney injury events than the heparin group; at 30 days, these differences were no longer significant. In this randomized trial of TAVR procedural pharmacotherapy, bivalirudin did not reduce rates of major bleeding at 48 h or net adverse cardiovascular events within 30 days compared with heparin. Although

Outcome of bioprosthetic valve replacement in dogs with tricuspid valve dysplasia.

PubMed

Bristow, P; Sargent, J; Luis Fuentes, V; Brockman, D

2017-04-01

To describe the short-term and long-term outcome in dogs with tricuspid valve dysplasia undergoing tricuspid valve replacement under cardiopulmonary bypass. Data were collected from the hospital records of all dogs that had undergone tricuspid valve replacement under cardiopulmonary bypass between 2006 and 2012. Dogs were considered candidates for tricuspid valve replacement if they had severe tricuspid valve regurgitation associated with clinical signs of cardiac compromise. Nine dogs of six different breeds were presented. Median age was 13 months (range 7 to 61 months), median weight 26·5 kg (range 9·7 to 59 kg). Eight bovine pericardial valves and one porcine aortic valve were used. One non-fatal intraoperative complication occurred. Complications during hospitalisation occurred in six dogs, four of which were fatal. Of the five dogs discharged, one presented dead due to haemothorax after minor trauma seven days later. The four remaining dogs survived a median of 533 days; all of these dogs received a bovine pericardial valve. Based on our results, tricuspid valve replacement with bovine or porcine prosthetic valves is associated with a high incidence of complications. © 2017 British Small Animal Veterinary Association.

Annual Outcomes With Transcatheter Valve Therapy: From the STS/ACC TVT Registry.

PubMed

Holmes, David R; Nishimura, Rick A; Grover, Frederick L; Brindis, Ralph G; Carroll, John D; Edwards, Fred H; Peterson, Eric D; Rumsfeld, John S; Shahian, David M; Thourani, Vinod H; Tuzcu, E Murat; Vemulapalli, Sreekanth; Hewitt, Kathleen; Michaels, Joan; Fitzgerald, Susan; Mack, Michael J

2015-12-29

The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry has been a joint initiative of the STS and the ACC in concert with multiple stakeholders. The TVT Registry has important information regarding patient selection, delivery of care, science, education, and research in the field of structural valvular heart disease. This report provides an overview on current U.S. TVT practice and trends. The emphasis is on demographics, in-hospital procedural characteristics, and outcomes of patients having transcatheter aortic valve replacement (TAVR) performed at 348 U.S. centers. The TVT Registry captured 26,414 TAVR procedures as of December 31, 2014. Temporal trends between 2012 and 2013 versus 2014 were compared. Comparison of the 2 time periods reveals that TAVR patients remain elderly (mean age 82 years), with multiple comorbidities, reflected by a high mean STS predicted risk of mortality (STS PROM) for surgical valve replacement (8.34%), were highly symptomatic (New York Heart Association functional class III/IV in 82.5%), frail (slow 5-m walk test in 81.6%), and have poor self-reported health status (median baseline Kansas City Cardiomyopathy Questionnaire score of 39.1). Procedure performance is changing, with an increased use of moderate sedation (from 1.6% to 5.1%) and increase in femoral access using percutaneous techniques (66.8% in 2014). Vascular complication rates are decreasing (from 5.6% to 4.2%), whereas site-reported stroke rates remain stable at 2.2%. The TVT Registry provides important information on characteristics and outcomes of TAVR in contemporary U.S. clinical practice. It can be used to identify trends in practice and opportunities for quality improvement. Copyright © 2015 American College of Cardiology Foundation and The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Very low intravenous contrast volume protocol for computed tomography angiography providing comprehensive cardiac and vascular assessment prior to transcatheter aortic valve replacement in patients with chronic kidney disease.

PubMed

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

2016-01-01

Transcatheter aortic valve replacement (TAVR) is a lifesaving procedure for many patients high risk for surgical aortic valve replacement. The prevalence of chronic kidney disease (CKD) is high in this population, and thus a very low contrast volume (VLCV) computed tomography angiography (CTA) protocol providing comprehensive cardiac and vascular imaging would be valuable. 52 patients with severe, symptomatic aortic valve disease, undergoing pre-TAVR CTA assessment from 2013-4 at Columbia University Medical Center were studied, including all 26 patients with CKD (eGFR<30 mL/min) who underwent a novel VLCV protocol (20 mL of iohexol at 2.5 mL/s), and 26 standard-contrast-volume (SCV) protocol patients. Using a 320-slice volumetric scanner, the protocol included ECG-gated volume scanning of the aortic root followed by medium-pitch helical vascular scanning through the femoral arteries. Two experienced cardiologists performed aortic annulus and root measurements. Vascular image quality was assessed by two radiologists using a 4-point scale. VLCV patients had mean (±SD) age 86 ± 6.5, BMI 23.9 ± 3.4 kg/m(2) with 54% men; SCV patients age 83 ± 8.8, BMI 28.7 ± 5.3 kg/m(2), 65% men. There was excellent intra- and inter-observer agreement for annular and root measurements, and excellent agreement with 3D-transesophageal echocardiographic measurements. Both radiologists found diagnostic-quality vascular imaging in 96% of VLCV and 100% of SCV cases, with excellent inter-observer agreement. This study is the first of its kind to report the feasibility and reproducibility of measurements for a VLCV protocol for comprehensive pre-TAVR CTA. There was excellent agreement of cardiac measurements and almost all studies were diagnostic quality for vascular access assessment. Copyright © 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

21 CFR 870.3925 - Replacement heart valve.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of any...

21 CFR 870.3925 - Replacement heart valve.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of any...

21 CFR 870.3925 - Replacement heart valve.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of any...

21 CFR 870.3925 - Replacement heart valve.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of any...

21 CFR 870.3925 - Replacement heart valve.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Replacement heart valve. 870.3925 Section 870.3925...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3925 Replacement heart valve. (a) Identification. A replacement heart valve is a device intended to perform the function of any...

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.

Predictors and Clinical Outcomes of Next-Day Discharge After Minimalist Transfemoral Transcatheter Aortic Valve Replacement.

PubMed

Kamioka, Norihiko; Wells, John; Keegan, Patricia; Lerakis, Stamatios; Binongo, Jose; Corrigan, Frank; Condado, Jose; Patel, Ateet; Forcillo, Jessica; Ogburn, Leslie; Dong, Andy; Caughron, Hope; Simone, Amy; Leshnower, Bradley; Devireddy, Chandan; Mavromatis, Kreton; Guyton, Robert; Stewart, James; Thourani, Vinod; Block, Peter C; Babaliaros, Vasilis

2018-01-22

This study sought to investigate predictors and safety of next-day discharge (NDD) after transcatheter aortic valve replacement (TAVR). Information about predictors and safety of NDD after TAVR is limited. The study reviewed 663 consecutive patients who underwent elective balloon-expandable TAVR (from July 2014 to July 2016) at our institution. We first determined predictors of NDD in patients who underwent minimalist transfemoral TAVR. After excluding cases with complications, we compared 30-day and 1-year outcomes between NDD patients and those with longer hospital stay using Cox regression adjusting for the Predicted Risk of Mortality provided by the Society of Thoracic Surgeons. The primary endpoint was the composite of mortality and readmission at 1 year. A total of 150 patients had NDD after TAVR and 210 patients had non-NDD. Mean age and the Society of Thoracic Surgeons Predicted Risk of Mortality were 80.7 ± 8.8 years and 6.6 ± 3.7%, respectively. Predictors of NDD were male sex (odds ratio [OR]: 2.02; 95% confidence interval [CI]: 1.28 to 3.18), absence of atrial fibrillation (OR: 1.62; 95% CI: 1.02 to 2.57), serum creatinine (OR: 0.71; 95% CI: 0.55 to 0.92), and age (OR: 0.95; 95% CI: 0.93 to 0.98). As expected, 84% of patients with complications had non-NDD. After excluding cases with complications, there was no difference in hazard rates of the 30-day composite outcome between NDD and non-NDD (hazard ratio: 0.62; 95% CI: 0.20 to 1.91), but the hazard of the composite outcome at 1 year was significantly lower in the NDD group (hazard ratio: 0.47; 95% CI: 0.27 to 0.81). This difference in the composite outcome can be explained by the lower hazard of noncardiovascular related readmission in the NDD group. Factors predicting NDD include male sex, absence of atrial fibrillation, lower serum creatinine, and younger age. When compared with patients without complications with a longer hospital stay, NDD appears to be safe, achieving similar 30-day and

Aortic valve surgery of the 21st century: sutureless AVR versus TAVI.

PubMed

Costache, Victor S; Moldovan, Horatiu; Arsenescu, Catalina; Costache, Andreea

2018-04-01

Surgical aortic valve replacement (sAVR) has been a safe, effective and time-proven technique and is still the standard of care all over the world for aortic valve treatment. The vast majority of centers perform this procedure by doing a median sternotomy with several disadvantages. While many others specialties went minimally invasive decades ago, in cardiovascular field transcatheter valve implantation was the first minimally invasive valvular procedure that gained rapid worldwide acceptance. Transcatheter valve replacement (TAVR) is now marketed as a procedure that should be performed under local anesthesia, by an interventional cardiologist via trans femoral route with no other healthcare professional invited to the patient selection or case planning. An increasing number of surgeons are promoting minimally invasive aortic valve replacement, which is gaining grounds, especially with the help of the new sutureless valve technology. With these two new technologies emerging, legitimate questions arise and need to be answered - which has the longest durability, lower complication rate and lower overall mortality.

Transcatheter aortic valve replacement with new-generation devices: A systematic review and meta-analysis.

PubMed

Barbanti, Marco; Buccheri, Sergio; Rodés-Cabau, Josep; Gulino, Simona; Généreux, Philippe; Pilato, Gerlando; Dvir, Danny; Picci, Andrea; Costa, Giuliano; Tamburino, Corrado; Leon, Martin B; Webb, John G

2017-10-15

The aim of this study was to conduct a weighted meta-analysis to determine the rates of acute (≤30days) major outcomes after (TAVR) with second-generation devices. A comprehensive search of multiple electronic databases from January 2011 to May 2017 was conducted using predefined criteria. New-generation TAVR devices were defined as any device which received CE mark approval or is still under evaluation for CE marking after CoreValve and SAPIEN XT prostheses. A total of 37 studies including 10,822 patients met inclusion criteria and were included in the analysis. Devices investigated in the studies were the following: SAPIEN 3 (n=5423, 45.9%), Lotus Valve (n=3007, %), Portico (n=130, 1.1%), JenaValve (n=345, 2.9%), Symetis Acurate (n=1314, 11,1%), and Evolut R (n=1603, 13.6%). Thirty-day all-cause and cardiovascular 30-day death were 2.2% (95% CI: 1.6% to 2.8%) and 1.6% (95% CI: 0.9% to 2.3%), respectively; Any stroke and major/disabling stroke occurred at a pooled estimate rate of 2.6% (95% CI: 2.0% to 3.3%) and 0.9% (95% CI: 0.2% to 1.6%), respectively; life-threatening bleeding, 3.9% (95% CI: 2.9% to 5.0%); major vascular complications, 4.5% (95% CI: 3.7% to 5.4%); pacemaker implantation, 16.2% (95% CI: 12.7% to 19.6%); more than mild aortic regurgitation, 1.6% (95% CI: 0.9 to 2.3). Second-generation TAVR devices are associated with very low mortality and major complications rates at 30-day, and improved prosthesis performance with <2% of patients having more than mild post-procedural aortic regurgitation. On the other hand, the need for pacemaker implantation seems to remain an unresolved issue, and warrants further investigation. Copyright © 2017 Elsevier B.V. All rights reserved.

The impact of waiting for intervention on costs and effectiveness: the case of transcatheter aortic valve replacement.

PubMed

Ribera, Aida; Slof, John; Ferreira-González, Ignacio; Serra, Vicente; García-Del Blanco, Bruno; Cascant, Purificació; Andrea, Rut; Falces, Carlos; Gutiérrez, Enrique; Del Valle-Fernández, Raquel; Morís-de laTassa, César; Mota, Pedro; Oteo, Juan Francisco; Tornos, Pilar; García-Dorado, David

2017-11-23

The economic crisis in Europe might have limited access to some innovative technologies implying an increase of waiting time. The purpose of the study is to evaluate the impact of waiting time on the costs and benefits of transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis. This is a cost-utility analysis from the perspective of the Spanish National Health Service. Results of two prospective hospital registries (158 and 273 consecutive patients) were incorporated into a probabilistic Markov model to compare quality adjusted life years (QALYs) and costs for TAVR after waiting for 3-12 months, relative to immediate TAVR. We simulated a cohort of 1000 patients, male, and 80 years old; other patient profiles were assessed in sensitivity analyses. As waiting time increased, costs decreased at the expense of lower survival and loss of QALYs, leading to incremental cost-effectiveness ratios for eliminating waiting lists of about 12,500 € per QALY. In subgroup analyses prioritization of patients for whom higher benefit was expected led to a smaller loss of QALYs. Concerning budget impact, long waiting lists reduced spending considerably and permanently. A shorter waiting time is likely to be cost-effective (considering commonly accepted willingness-to-pay thresholds in Europe) relative to 3 months or longer waiting periods. If waiting lists are nevertheless seen as unavoidable due to severe but temporary budgetary restrictions, prioritizing patients for whom higher benefit is expected appears to be a way of postponing spending without utterly sacrificing patients' survival and quality of life.

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

PubMed Central

El-Gamel, Adam

2013-01-01

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

Valve assembly having remotely replaceable bearings

DOEpatents

Johnson, Evan R.; Tanner, David E.

1980-01-01

A valve assembly having remotely replaceable bearings is disclosed wherein a valve disc is supported within a flow duct for rotation about a pair of axially aligned bearings, one of which is carried by a spindle received within a diametral bore in the valve disc, and the other of which is carried by a bearing support block releasably mounted on the duct circumferentially of an annular collar on the valve disc coaxial with its diametrical bore. The spindle and bearing support block are adapted for remote removal to facilitate servicing or replacement of the valve disc support bearings.

[Longterm results of mitral valve replacement (author's transl)].

PubMed

Erhard, W; Reichmann, M; Delius, W; Sebening, H; Herrmann, G

1977-04-22

210 patients were followed up by the actuary method for over 5 years after isolated mitral valve replacement or a double valve replacement. After isolated valve replacement the one month survival including the operative mortality was 92+/-2%. The survival after one year was 83+/-3% and after 5 years 66+/-7%. The five year survival of patients in preoperative class III (according to the NYHA) was 73+/-8% and of class IV 57+/-8% (P less than or equal to 0.1). A comparison of valve replacements for pure mitral stenosis or mitral insufficiency showed no statistically significant differences. In the 37 patients who had a double valve replacement the survival risk was not increased in comparison with those patients who had had a single valve replacement. Age above 45 years and a preoperative markedly raised pulmonary arteriolar resistance reduced the chances of survival.

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.

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

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

PubMed

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

2015-08-01

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

A Pilot Analysis of the Association Between Types of Monitored Anesthesia Care Drugs and Outcomes in Transfemoral Aortic Valve Replacement Performed Without General Anesthesia.

PubMed

Chen, Eric Y; Sukumar, Nitin; Dai, Feng; Akhtar, Shamsuddin; Schonberger, Robert B

2018-04-01

The types of agents used for monitored anesthesia care (MAC) and their possible differential effects on outcomes have received less study despite increased use over general anesthesia (GA) in transfemoral aortic valve replacements (TAVRs). In this pilot analysis of patients undergoing TAVR using MAC, the authors described the anesthetic agents used and sought to investigate the possible association of anesthetic agent choice with outcomes and the extent to which total weight and time-adjusted doses of anesthetics declined with increasing 10-year age increments. Retrospective observational study. Tertiary teaching hospital. Ninety-three participants scheduled to undergo TAVR, with a primary plan of conscious sedation between November 2014 and June 2016, were included. None. Types of MAC were divided into 4 primary groups, but 2 groups were focused: propofol (n = 39) and dexmedetomidine plus propofol (n = 34). Conversion to GA occurred in 6 participants (6.45%) and was not associated with the type of sedation received. The authors also compared patients who received dexmedetomidine with those who did not in accordance with their a priori analytic plan. There were no associations between the use of dexmedetomidine and postoperative delirium or intensive care unit/hospital length of stay. No significant trends in medication dose adjustments were seen across increasing 10-year age increments. A wide breadth of MAC medications is in use among TAVR patients and does not support differences in outcomes. Despite recommendations to reduce anesthetic drug dosing in the elderly, no significant trends in dose reduction with increasing age were noted. Copyright © 2017 Elsevier Inc. All rights reserved.

3D Assessment of Features Associated With Transvalvular Aortic Regurgitation After TAVR: A Real-Time 3D TEE Study.

PubMed

Shibayama, Kentaro; Mihara, Hirotsugu; Jilaihawi, Hasan; Berdejo, Javier; Harada, Kenji; Itabashi, Yuji; Siegel, Robert; Makkar, Raj R; Shiota, Takahiro

2016-02-01

This study of 3-dimensional (3D) transesophageal echocardiography (TEE) aimed to demonstrate features associated with transvalvular aortic regurgitation (AR) after transcatheter aortic valve replacement (TAVR) and to confirm the fact that a gap between the native aortic annulus and prosthesis is associated with paravalvular AR. The mechanism of AR after TAVR, particularly that of transvalvular AR, has not been evaluated adequately. All patients with severe aortic stenosis who underwent TAVR with the Sapien device (Edwards Lifesciences, Irvine, California) had 3D TEE of the pre-procedural native aortic annulus and the post-procedural prosthetic valve. In the 201 patients studied, the total AR was mild in 67 patients (33%), moderate in 21 patients (10%), and severe in no patients. There were 20 patients with transvalvular AR and 82 patients with paravalvular AR. Fourteen patients had both transvalvular and paravalvular AR. Patients with transvalvular AR had larger prosthetic expansion (p <0.05), a more elliptical prosthetic shape at the prosthetic commissure level (p <0.01) and more anti-anatomical position (p <0.001), which was defined as malposition of the prosthetic commissures in relation to the native commissures, than the patients without transvalvular AR. Age (odds ratio [OR]: 1.05; 95% confidence interval [CI]: 1.01 to 1.09; p < 0.05) and effective area oversizing (OR: 0.97; 95% CI: 0.93 to 0.99, p <0.05) were associated with mild or greater paravalvular AR. 3D TEE successfully demonstrated the features associated with transvalvular AR, such as large prosthetic expansion, elliptical prosthetic shape, and anti-anatomical position of prosthesis. Additionally, effective area oversizing was associated with paravalvular AR. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Inclusion of Functional Status Measures in the Risk Adjustment of 30-Day Mortality After Transcatheter Aortic Valve Replacement: A Report From the Society of Thoracic Surgeons/American College of Cardiology TVT Registry.

PubMed

Arnold, Suzanne V; O'Brien, Sean M; Vemulapalli, Sreekanth; Cohen, David J; Stebbins, Amanda; Brennan, J Matthew; Shahian, David M; Grover, Fred L; Holmes, David R; Thourani, Vinod H; Peterson, Eric D; Edwards, Fred H

2018-03-26

The aim of this study was to develop and validate a risk adjustment model for 30-day mortality after transcatheter aortic valve replacement (TAVR) that accounted for both standard clinical factors and pre-procedural health status and frailty. Assessment of risk for TAVR is important both for patient selection and provider comparisons. Prior efforts for risk adjustment have focused on in-hospital mortality, which is easily obtainable but can be biased because of early discharge of ill patients. Using data from patients who underwent TAVR as part of the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry (June 2013 to May 2016), a hierarchical logistic regression model to estimate risk for 30-day mortality after TAVR based only on pre-procedural factors and access site was developed and internally validated. The model included factors from the original TVT Registry in-hospital mortality model but added the Kansas City Cardiomyopathy Questionnaire (health status) and gait speed (5-m walk test). Among 21,661 TAVR patients at 188 sites, 1,025 (4.7%) died within 30 days. Independent predictors of 30-day death included older age, low body weight, worse renal function, peripheral artery disease, home oxygen, prior myocardial infarction, left main coronary artery disease, tricuspid regurgitation, nonfemoral access, worse baseline health status, and inability to walk. The predicted 30-day mortality risk ranged from 1.1% (lowest decile of risk) to 13.8% (highest decile of risk). The model was able to stratify risk on the basis of patient factors with good discrimination (C = 0.71 [derivation], C = 0.70 [split-sample validation]) and excellent calibration, both overall and in key patient subgroups. A clinical risk model was developed for 30-day death after TAVR that included clinical data as well as health status and frailty. This model will facilitate tracking outcomes over time as TAVR expands to lower risk patients and

Aortic valve replacement for papillary fibroelastoma.

PubMed

Arikan, Ali Ahmet; Omay, Oğuz; Aydın, Fatih; Kanko, Muhip; Gür, Sibel; Derviş, Emir; Yılmaz, Cansu Eda; Müezzinoğlu, Bahar

2017-06-01

Surgery is indicated for symptomatic patients with papillary fibroelastomas (PFE) on the aortic valve. The valve is commonly spared during tumor excision. Rarely, aortic valve replacement (AVR) is needed. We present a case requiring AVR for an aortic valve PFE and review the literature to determine the risk factors for failure of aortic valve-sparing techniques in patients with PFE. © 2017 Wiley Periodicals, Inc.

Mitral valve replacement with the Hancock stabilized glutaraldehyde valve. Clinical and laboratory evaluation.

PubMed

Buch, W S; Pipkin, R D; Hancock, W D; Fogarty, T J

1975-11-01

From March 1971 through April 1975, one hundred twenty patients underwent mitral valve replacement with a Hancock "stabilized glutaraldehyde process" porcine aortic xenograft. A simultaneous canine experimental series was also carried out. In the clinical series, the early mortality was 8.3%. Actuarial analyses of all patients predicts survival at two years of 81.0% and at four years of 70.0%. The predicted survival for patients without coronary disease or prior prosthetic valve replacement is 87.5% at two years and 77.5% at four years. There were four thromboembolic episodes, a rate of 2.4% per patient-year. None were fatal. No valve failure were noted. Histologic examination and shrink temperature analysis of recovered valves show excellent tissue preservation at 40 months. The data indicate that the Hancock valve is durable, enjoys a low incidence of thromboembolism, and may be the valve of choice for mitral valve replacement.

Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study.

PubMed

Baumbach, Andreas; Mullen, Michael; Brickman, Adam M; Aggarwal, Suneil K; Pietras, Cody G; Forrest, John K; Hildick-Smith, David; Meller, Stephanie M; Gambone, Louise; den Heijer, Peter; Margolis, Pauliina; Voros, Szilard; Lansky, Alexandra J

2015-05-01

This study aimed to evaluate the safety and performance of the TriGuard™ Embolic Deflection Device (EDD), a nitinol mesh filter positioned in the aortic arch across all three major cerebral artery take-offs to deflect emboli away from the cerebral circulation, in patients undergoing transcatheter aortic valve replacement (TAVR). The prospective, multicentre DEFLECT I study (NCT01448421) enrolled 37 consecutive subjects undergoing TAVR with the TriGuard EDD. Subjects underwent clinical and cognitive follow-up to 30 days; cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed pre-procedure and at 4±2 days post procedure. The device performed as intended with successful cerebral coverage in 80% (28/35) of cases. The primary safety endpoint (in-hospital EDD device- or EDD procedure-related cardiovascular mortality, major stroke disability, life-threatening bleeding, distal embolisation, major vascular complications, or need for acute cardiac surgery) occurred in 8.1% of subjects (VARC-defined two life-threatening bleeds and one vascular complication). The presence of new cerebral ischaemic lesions on post-procedure DW-MRI (n=28) was similar to historical controls (82% vs. 76%, p=NS). However, an exploratory analysis found that per-patient total lesion volume was 34% lower than reported historical data (0.2 vs. 0.3 cm3), and 89% lower in patients with complete (n=17) versus incomplete (n=10) cerebral vessel coverage (0.05 vs. 0.45 cm3, p=0.016). Use of the first-generation TriGuard EDD during TAVR is safe, and device performance was successful in 80% of cases during the highest embolic-risk portions of the TAVR procedure. The potential of the TriGuard EDD to reduce total cerebral ischaemic burden merits further randomised investigation.

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

PubMed

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

2018-05-02

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

Heart valve replacement with the Sorin tilting-disc prosthesis. A 10-year experience.

PubMed

Milano, A; Bortolotti, U; Mazzucco, A; Mossuto, E; Testolin, L; Thiene, G; Gallucci, V

1992-02-01

From 1978 to 1988, 697 patients with a mean age of 48 +/- 11 years (range 5 to 75 years) received a Sorin tilting-disc prosthesis; 358 had had aortic valve replacement, 247 mitral valve replacement, and 92 mitral and aortic valve replacement. Operative mortality rates were 7.8%, 11.3%, and 10.8%, respectively, in the three groups. Cumulative duration of follow-up is 1650 patient-years for aortic valve replacement (maximum follow-up 11.4 years), 963 patient-years for mitral valve replacement (maximum follow-up 9.9 years) and 328 patient-years for mitral and aortic valve replacement (maximum follow-up 9.4 years). Actuarial survival at 9 years is 72% +/- 4% after mitral valve replacement, 70% +/- 3% after aortic valve replacement, and 50% +/- 12% after mitral and aortic valve replacement, and actuarial freedom from valve-related deaths is 97% +/- 2% after mitral valve replacement, 92% +/- 2% after aortic valve replacement, and 62% +/- 15% after mitral and aortic valve replacement. Thromboembolic events occurred in 21 patients with aortic valve replacement (1.3% +/- 0.2%/pt-yr), in 12 with mitral valve replacement (1.2% +/- 0.3% pt-yr), and in seven with mitral and aortic valve replacement (2.1% +/- 0.8%), with one case of prosthetic thrombosis in each group; actuarial freedom from thromboembolism at 9 years is 92% +/- 3% after mitral valve replacement, 91% +/- 3% after aortic valve replacement, and 74% +/- 16% after mitral and aortic valve replacement. Anticoagulant-related hemorrhage was observed in 15 patients after aortic valve replacement (0.9% +/- 0.2%/pt-yr), in 9 after mitral valve replacement (0.9% +/- 0.3%/pt-yr), and in 6 with mitral and aortic valve replacement (0.9% +/- 0.5%/pt-yr); actuarial freedom from this complication at 9 years is 94% +/- 2% after aortic valve replacement, 91% +/- 4% after mitral valve replacement, and 68% +/- 16% after mitral and aortic valve replacement. Actuarial freedom from reoperation at 9 years is 97% +/- 2% after mitral and

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

PubMed

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

2018-06-01

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

Prospective ECG-triggered, axial 4-D imaging of the aortic root, valvular, and left ventricular structures: a lower radiation dose option for preprocedural TAVR imaging.

PubMed

Bolen, Michael A; Popovic, Zoran B; Dahiya, Arun; Kapadia, Samir R; Tuzcu, E Murat; Flamm, Scott D; Halliburton, Sandra S; Schoenhagen, Paul

2012-01-01

Transcatheter valve interventions rely on imaging for patient selection, preprocedural planning, and intraprocedural guidance. We explored the use of prospective electrocardiogram (ECG)-triggered 4-dimensional (4-D) CT imaging in patients evaluated for transcatheter aortic valve replacement (TAVR). A total of 47 consecutive patients underwent 128-slice dual-source CT with wide-window dose-modulated prospective ECG-triggered, axial acquisition of the aortic root, reconstructed during diastolic and systolic cardiac phases. Image quality was evaluated, aortic root and left ventricular (LV) geometry and function were analyzed, and radiation exposure was estimated. Image quality was generally good, with 41 of 47 (87%) patients scored as good or excellent. The mean aortic valve area was 0.93 ± 0.24 cm(2). Mean LV ejection fraction was 56.8% ± 16.4%, and mean LV mass was 130.4 ± 43.8 g. The minor diameter of the annulus was larger in systole (systole, 2.29 ± 0.24 cm; diastole, 2.14 ± 0.25 cm; P = 0.006), but the mean and major diameters did not vary significantly between systole and diastole. The mean estimated effective dose was 5.9 ± 2.4 mSv. Multiphase, prospective ECG-triggered axial image acquisition is a lower dose acquisition technique for 4-D aortic root imaging in patients being considered for TAVR. Copyright © 2012 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

Value of a noise-optimized virtual monoenergetic reconstruction technique in dual-energy CT for planning of transcatheter aortic valve replacement.

PubMed

Martin, Simon S; Albrecht, Moritz H; Wichmann, Julian L; Hüsers, Kristina; Scholtz, Jan-Erik; Booz, Christian; Bodelle, Boris; Bauer, Ralf W; Metzger, Sarah C; Vogl, Thomas J; Lehnert, Thomas

2017-02-01

To evaluate objective and subjective image quality of a noise-optimized virtual monoenergetic imaging (VMI+) reconstruction technique in dual-energy computed tomography (DECT) angiography prior to transcatheter aortic valve replacement (TAVR). Datasets of 47 patients (35 men; 64.1 ± 10.9 years) who underwent DECT angiography of heart and vascular access prior to TAVR were reconstructed with standard linear blending (F_0.5), VMI+, and traditional monoenergetic (VMI) algorithms in 10-keV intervals from 40-100 keV. Signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of 564 arterial segments were evaluated. Subjective analysis was rated by three blinded observers using a Likert scale. Mean SNR and CNR were highest in 40 keV VMI+ series (SNR, 27.8 ± 13.0; CNR, 26.3 ± 12.7), significantly (all p < 0.001) superior to all VMI series, which showed highest values at 70 keV (SNR, 18.5 ± 7.6; CNR, 16.0 ± 7.4), as well as linearly-blended F_0.5 series (SNR, 16.8 ± 7.3; CNR, 13.6 ± 6.9). Highest subjective image quality scores were observed for 40, 50, and 60 keV VMI+ reconstructions (all p > 0.05), significantly superior to all VMI and standard linearly-blended images (all p < 0.01). Low-keV VMI+ reconstructions significantly increase CNR and SNR compared to VMI and standard linear-blending image reconstruction and improve subjective image quality in preprocedural DECT angiography in the context of TAVR planning. • VMI+ combines increased contrast with reduced image noise. • VMI+ shows substantially less image noise than traditional VMI. • 40-keV reconstructions show highest SNR/CNR of the aortic and iliofemoral access route. • Observers overall prefer 60 keV VMI+ images. • VMI+ DECT imaging helps improve image quality for TAVR planning.

Leaving Moderate Tricuspid Valve Regurgitation Alone at the Time of Pulmonary Valve Replacement: A Worthwhile Approach.

PubMed

Kogon, Brian; Mori, Makoto; Alsoufi, Bahaaldin; Kanter, Kirk; Oster, Matt

2015-06-01

Pulmonary valve disruption in patients with tetralogy of Fallot and congenital pulmonary stenosis often results in pulmonary insufficiency, right ventricular dilation, and tricuspid valve regurgitation. Management of functional tricuspid regurgitation at the time of subsequent pulmonary valve replacement remains controversial. Our aims were to (1) analyze tricuspid valve function after pulmonary valve replacement through midterm follow-up and (2) determine the benefits, if any, of concomitant tricuspid annuloplasty. Thirty-five patients with tetralogy of Fallot or congenital pulmonary stenosis were analyzed. All patients had been palliated in childhood by disrupting the pulmonary valve, and all patients had at least moderate tricuspid valve regurgitation at the time of subsequent pulmonary valve replacement. Preoperative and serial postoperative echocardiograms were analyzed. Pulmonary and tricuspid regurgitation, along with right ventricular dilation and dysfunction were scored as 0 (none), 1 (mild), 2 (moderate), and 3 (severe). Right ventricular volume and area were also calculated. Comparisons were made between patients who underwent pulmonary valve replacement alone and those who underwent concomitant tricuspid valve annuloplasty. At 1 month after pulmonary valve replacement, there were significant reductions in pulmonary valve regurgitation (mean 3 vs 0.39, p < 0.0001), tricuspid valve regurgitation (mean 2.33 vs 1.3, p < 0.0001), and in right ventricular dilation, volume, and area. There was no difference in the degree of tricuspid regurgitation 1 month postoperatively between patients who underwent concomitant tricuspid annuloplasty and those who underwent pulmonary valve replacement alone (mean 1.31 vs 1.29, p = 0.81). However, at latest follow-up (mean 7.0 ± 2.8 years), the degree of tricuspid regurgitation was significantly higher in the concomitant annuloplasty group (mean 1.87 vs 1.12, p = 0.005). In patients with at least moderate tricuspid valve

Transcatheter Mitral Valve Replacement for Native and Failed Bioprosthetic Mitral Valves

PubMed Central

Sarkar, Kunal; Reardon, Michael J.; Little, Stephen H.; Barker, Colin M.; Kleiman, Neal S.

2017-01-01

Transcatheter mitral valve replacement (TMVR) is a novel approach for treatment of severe mitral regurgitation. A number of TMVR devices are currently undergoing feasibility trials using both transseptal and transapical routes for device delivery. Overall experience worldwide is limited to fewer than 200 cases. At present, the 30-day mortality exceeds 30% and is attributable to both patient- and device-related factors. TMVR has been successfully used to treat patients with degenerative mitral stenosis (DMS) as well as failed mitral bioprosthesis and mitral repair using transcatheter mitral valve-in-valve (TMViV)/valve-in-ring (ViR) repair. These patients are currently treated with devices designed for transcatheter aortic valve replacement. Multicenter registries have been initiated to collect outcomes data on patients currently undergoing TMViV/ViR and TMVR for DMS and have confirmed the feasibility of TMVR in these patients. However, the high periprocedural and 30-day event rates underscore the need for further improvements in device design and multicenter randomized studies to delineate the role of these technologies in patients with mitral valve disease. PMID:29743999

Valve replacement in children: a challenge for a whole life.

PubMed

Henaine, Roland; Roubertie, François; Vergnat, Mathieu; Ninet, Jean

2012-10-01

Valvular pathology in infants and children poses numerous challenges to the paediatric cardiac surgeon. Without question, valvular repair is the goal of intervention because restoration of valvular anatomy and physiology using native tissue allows for growth and a potentially better long-term outcome. When reconstruction fails or is not feasible, valve replacement becomes inevitable. Which valve for which position is controversial. Homograft and bioprosthetic valves achieve superior haemodynamic results initially but at the cost of accelerated degeneration. Small patient size and the risk of thromboembolism limit the usefulness of mechanical valves, and somatic outgrowth is an universal problem with all available prostheses. The goal of this article is to address valve replacement options for all four valve positions within the paediatric population. We review current literature and our practice to support our preferences. To summarize, a multitude of opinions and surgical experiences exist. Today, the valve choices that seem without controversy are bioprosthetic replacement of the tricuspid valve and Ross or Ross-Konno procedures when necessary for the aortic valve. On the other hand, bioprostheses may be implanted when annular pulmonary diameter is adequate; if not or in case of right ventricular outflow tract discontinuity, it is better to use a pulmonary homograft with the Ross procedure. Otherwise, a valved conduit. Mitral valve replacement remains the most problematic; the mechanical prosthesis must be placed in the annular position, avoiding oversizing. Future advances with tissue-engineered heart valves for all positions and new anticoagulants may change the landscape for valve replacement in the paediatric population. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Anesthetic Considerations for Transcatheter Pulmonary Valve Replacement.

PubMed

Gregory, Stephen H; Zoller, Jonathan K; Shahanavaz, Shabana; Chilson, Kelly L; Ridley, Clare H

2018-02-01

The introduction of transcatheter therapy for valvular heart disease has revolutionized the care of patients with valvular disorders. Pathologic regurgitation or stenosis of the pulmonary valve, right ventricular outflow tract, or a right ventricle-to-pulmonary artery conduit represent emerging indications for transcatheter therapy. To date, minimal literature exists detailing the anesthetic management of patients undergoing transcatheter pulmonary valve replacement. In this review, the pathophysiology and indications for transcatheter pulmonary valve replacement and possible complications unique to this procedure are reviewed. Anesthetic management, including preoperative assessment, intraoperative considerations, and early postoperative monitoring, are discussed. Copyright © 2018 Elsevier Inc. All rights reserved.

Recurrent pannus formation causing prosthetic aortic valve dysfunction: is excision without valve re-replacement applicable?

PubMed

Darwazah, Ahmad K

2012-06-29

Prosthetic valve dysfunction at aortic position is commonly caused by pannus formation. The exact etiology is not known. It arises from ventricular aspect of the prosthesis encroaching its leaflets causing stenosis or it may remain localized causing left ventricular outflow tract obstruction without affecting valve function.The difference in location entails different approaches in management. Such a pathology requires surgical excision of the pannus with or without valve re-replacement.A recurrent pannus was observed in a female patient who needed repeated surgical intervention to excise a localized pannus without re-replacement of a well functioning prosthetic valve.Management of our case presents several questions, whether recurrence of pannus is caused by sparing the prosthetic valve, is it simply an exaggeration of an inflammatory healing process in certain individuals or is it ideal to re-replace the valve despite a well preserved function.

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

PubMed

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

2018-05-11

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

Recurrent pannus formation causing prosthetic aortic valve dysfunction: Is excision without valve re-replacement applicable?

PubMed Central

2012-01-01

Prosthetic valve dysfunction at aortic position is commonly caused by pannus formation. The exact etiology is not known. It arises from ventricular aspect of the prosthesis encroaching its leaflets causing stenosis or it may remain localized causing left ventricular outflow tract obstruction without affecting valve function. The difference in location entails different approaches in management. Such a pathology requires surgical excision of the pannus with or without valve re-replacement. A recurrent pannus was observed in a female patient who needed repeated surgical intervention to excise a localized pannus without re-replacement of a well functioning prosthetic valve. Management of our case presents several questions, whether recurrence of pannus is caused by sparing the prosthetic valve, is it simply an exaggeration of an inflammatory healing process in certain individuals or is it ideal to re-replace the valve despite a well preserved function. PMID:22747790

Should patients with Björk-Shiley valves undergo prophylactic replacement?

PubMed

Birkmeyer, J D; Marrin, C A; O'Connor, G T

1992-08-29

About 85,000 patients have undergone replacement of diseased heart valves with prosthetic Björk-Shiley convexo-concave (CC) valves. These valves are prone to fracture of the outlet strut, which leads to acute valve failure that is usually fatal. Should patients with these valves undergo prophylactic replacement to avoid fracture? The incidence of strut fracture varies between 0% and 1.5% per year, depending on valve opening angle (60 degrees or 70 degrees), diameter (less than 29 mm or greater than or equal to 29 mm), and location (aortic or mitral). Other factors include the patient's life expectancy and the expected morbidity and mortality associated with reoperation. We have used decision analysis to identify the patients most likely to benefit from prophylactic reoperation. The incidence of outlet strut fracture was estimated from the data of three large studies on CC valves, and stratified by opening angle, diameter, and location. A Markov decision analysis model was used to estimate life expectancy for patients undergoing prophylactic valve replacement and for those not undergoing reoperation. Prophylactic valve replacement does not benefit patients with CC valves that have low strut fracture risks (60 degrees aortic valves and less than 29 mm, 60 degrees mitral valves). For most patients with CC valves that have high strut fracture risks (greater than or equal to 29 mm, 70 degrees CC), prophylactic valve replacement increases life expectancy. However, elderly patients with such valves benefit from prophylactic reoperation only if the risk of operative mortality is low. Patient age and operative risk are most important in recommendations for patients with CC valves that have intermediate strut fracture risks (less than 29 mm, 70 degrees valves and greater than or equal to 29 mm, 60 degrees mitral valves). For all patients and their doctors facing the difficult decision on whether to replace CC valves, individual estimates of operative mortality risk that

Mitral valve replacement with preservation of the subvalvular apparatus.

PubMed

Reardon, M J; David, T E

1999-03-01

The introduction of the Starr-Edwards valve allowed complete replacement of diseased left-sided heart valves. With improved cardiopulmonary bypass, myocardial protection, and surgical techniques the mortality rate from aortic valve replacement decreased substantially, whereas the mortality rate from mitral valve replacement remained high, largely because of low cardiac output syndrome. Increasing use of mitral valve repair techniques resulted in a marked decrease in short-term and long-term morbidity and mortality when treating patients with mitral regurgitation. Some believed that this resulted from maintenance of the mitral annular papillary muscle continuity during mitral valve repair. Subsequent experimental and clinical studies have validated the positive short-term and long-term effects of maintaining the integrity of the mitral valve subvalvular apparatus. This article considers the history of the clinical use of preservation of the subvalvular apparatus, the physiologic studies examining this concept, and the clinical data available on its use. It also examines the following: 1) mitral stenosis versus mitral regurgitation and the preservation of the subvalvular apparatus; 2) whether the anterior, posterior, or both areas of the subvalvular apparatus should be preserved; and 3) the surgical techniques for the preservation of the subvalvular apparatus and valve implantation.

Impact of Liver Indicators on Clinical Outcome in Patients Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Wendt, Daniel; Kahlert, Philipp; Canbay, Ali; Knipp, Stephan; Thoenes, Martin; Cremer, Gordina; Al-Rashid, Fadi; Jánosi, Rolf-Alexander; El-Chilali, Karim; Kamler, Markus; El Gabry, Mohamed; Marx, Philipp; Dohle, Daniel Sebastian; Tsagakis, Konstantinos; Benedik, Jaroslav; Gerken, Guido; Rassaf, Tienush; Jakob, Heinz; Thielmann, Matthias

2017-10-01

Liver dysfunction increases death and morbidity after cardiac operations. There are currently no data evaluating liver function in patients undergoing transcatheter aortic valve replacement (TAVR). We aimed therefore to evaluate our TAVR results in regard to liver function. A total of 640 consecutive TAVR patients were evaluated. Of those, 11 patients presented with chronic liver disease before TAVR. The Model for End-Stage Liver Disease score was used to measure liver function in these patients. The primary study end point was 30-day mortality in patients presenting with liver dysfunction. Secondary study end point was liver enzymes after TAVR. The mean Model for End-Stage Liver Disease score in patients with chronic liver disease was 16.8 ± 6.2 (median, 18; range, 7 to 26). The 30-day mortality was 9.1% (57 of 629) in patients presenting without liver disease and 9.1% (1 of 11) in patients with liver disease (p = 1.00). Patients with chronic liver disease showed significantly higher preoperative levels of γ-glutamyl transpeptidase (p < 0.001). After TAVR, we observed a significant increase in alanine aminotransferase on postoperative day 3 compared with preoperative values (p < 0.001), accompanied by a decrease in albumin (p < 0.001). Liver cirrhosis per se is not considered as a contraindication for cardiac operations. In the present study, we did not observe a higher 30-day mortality rate in liver cirrhotic patients undergoing TAVR, suggesting TAVR as a feasible alternative with acceptable outcomes in patients with chronic liver disease. Moreover, the present study is the first to evaluate liver variables in patients undergoing TAVR. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Cost-effectiveness of homograft heart valve replacement surgery: an introductory study.

PubMed

Yaghoubi, Mohsen; Aghayan, Hamid Reza; Arjmand, Babak; Emami-Razavi, Seyed Hassan

2011-05-01

The clinical effectiveness of heart valve replacement surgery has been well documented. Mechanical and homograft valves are used routinely for replacement of damaged heart valves. Homograft valves are produced in our country but we import the mechanical valves. To our knowledge the cost-effectiveness of homograft valve has not been assessed. The objective of the present study was to compare the cost-effectiveness of homograft valve replacement with mechanical valve replacement surgery. Our samples were selected from 200 patients that underwent homograft and mechanical heart valve replacement surgery in Imam-Khomeini hospital (2000-2005). In each group we enrolled 30 patients. Quality of life was measured using the SF-36 questionnaire and utility was measured in quality-adjusted life years (QALYs). For each group we calculated the price of heart valve and hospitalization charges. Finally the cost-effectiveness of each treatment modalities were summarized as costs per QALYs gained. Forty male and twenty female participated in the study. The mean score of quality of life was 66.06 (SD = 9.22) in homograft group and 57.85 (SD = 11.30) in mechanical group (P < 0.05). The mean QALYs gained in homograft group was 0.67 more than mechanical group. The incremental cost-effectiveness ratio (ICER) revealed a cost savings of 1,067 US$ for each QALY gained in homograft group. Despite limitation of this introductory study, we concluded that homograft valve replacement was more effective and less expensive than mechanical valve. These findings can encourage healthcare managers and policy makers to support the production of homograft valves and allocate more recourse for developing such activities.

Evaluation of mitral valve replacement anchoring in a phantom

NASA Astrophysics Data System (ADS)

McLeod, A. Jonathan; Moore, John; Lang, Pencilla; Bainbridge, Dan; Campbell, Gordon; Jones, Doug L.; Guiraudon, Gerard M.; Peters, Terry M.

2012-02-01

Conventional mitral valve replacement requires a median sternotomy and cardio-pulmonary bypass with aortic crossclamping and is associated with significant mortality and morbidity which could be reduced by performing the procedure off-pump. Replacing the mitral valve in the closed, off-pump, beating heart requires extensive development and validation of surgical and imaging techniques. Image guidance systems and surgical access for off-pump mitral valve replacement have been previously developed, allowing the prosthetic valve to be safely introduced into the left atrium and inserted into the mitral annulus. The major remaining challenge is to design a method of securely anchoring the prosthetic valve inside the beating heart. The development of anchoring techniques has been hampered by the expense and difficulty in conducting large animal studies. In this paper, we demonstrate how prosthetic valve anchoring may be evaluated in a dynamic phantom. The phantom provides a consistent testing environment where pressure measurements and Doppler ultrasound can be used to monitor and assess the valve anchoring procedures, detecting pararvalvular leak when valve anchoring is inadequate. Minimally invasive anchoring techniques may be directly compared to the current gold standard of valves sutured under direct vision, providing a useful tool for the validation of new surgical instruments.

Using Time-Driven Activity-Based Costing as a Key Component of the Value Platform: A Pilot Analysis of Colonoscopy, Aortic Valve Replacement and Carpal Tunnel Release Procedures.

PubMed

Martin, Jacob A; Mayhew, Christopher R; Morris, Amanda J; Bader, Angela M; Tsai, Mitchell H; Urman, Richard D

2018-04-01

Time-driven activity-based costing (TDABC) is a methodology that calculates the costs of healthcare resources consumed as a patient moves along a care process. Limited data exist on the application of TDABC from the perspective of an anesthesia provider. We describe the use of TDABC, a bottom-up costing strategy and financial outcomes for three different medical-surgical procedures. In each case, a multi-disciplinary team created process maps describing the care delivery cycle for a patient encounter using the TDABC methodology. Each step in a process map delineated an activity required for delivery of patient care. The resources (personnel, equipment and supplies) associated with each step were identified. A per minute cost for each resource expended was generated, known as the capacity cost rate, and multiplied by its time requirement. The total cost for an episode of care was obtained by adding the cost of each individual resource consumed as the patient moved along a clinical pathway. We built process maps for colonoscopy in the gastroenterology suite, calculated costs of an aortic valve replacement by comparing surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) techniques, and determined the cost of carpal tunnel release in an operating room versus an ambulatory procedure room. TDABC is central to the value-based healthcare platform. Application of TDABC provides a framework to identify process improvements for health care delivery. The first case demonstrates cost-savings and improved wait times by shifting some of the colonoscopies scheduled with an anesthesiologist from the main hospital to the ambulatory facility. In the second case, we show that the deployment of an aortic valve via the transcatheter route front loads the costs compared to traditional, surgical replacement. The last case demonstrates significant cost savings to the healthcare system associated with re-organization of staff required to execute a

Fluid Dynamics of Thrombosis in Transcatheter Aortic Valves

NASA Astrophysics Data System (ADS)

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

2017-11-01

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

Aortic valve replacement with the Biocor PSB stentless xenograft.

PubMed

Bertolini, P; Luciani, G B; Vecchi, B; Pugliese, P; Mazzucco, A

1998-08-01

The midterm clinical results after aortic valve replacement with the Biocor PSB stentless xenograft on all patients operated between October 1992 and October 1996 were reviewed. One hundred six patients, aged 70+/-6 years, had aortic valve replacement for aortic stenosis (67%), regurgitation (11%), or both (22%). Associated procedures were done in 49 patients (46%), including coronary artery bypass in 30 patients, mitral valve repair/replacement in 16, and ascending aorta replacement in 5 patients. Aortic cross-clamp and cardiopulmonary bypass times were 96+/-24 and 129+/-31 minutes, respectively. There were 3 (3%) early deaths due to low output (2 patients) and cerebrovascular accident (1 patient). Follow-up of survivors ranged from 6 to 66 months (mean, 39+/-14 months). Survival was 94%+/-2% and 90%+/-3% at 1 and 5 years. There were 5 late deaths due to cardiac cause (2), cancer (2), and pulmonary embolism (1 patient). No patient had structural valve deterioration, whereas 100% and 95%+/-3% were free from valve-related events at 1 and 5 years. There were two reoperations due to narrowing of the left coronary ostium and endocarditis, with an actuarial freedom from reoperation of 99%+/-1% and 98+/-1% at 1 and 5 years, respectively. Functional results demonstrated a mean peak transprosthetic gradient of 16+/-12 mm Hg, with only 1 patient (1%) with a 55 mm Hg gradient. No cases of valve regurgitation greater than mild were recorded at follow-up. Assessment of New York Heart Association functional class demonstrated a significant improvement (2.9+/-0.6 versus 1.4+/-0.7; p=0.01). All patients were free from anticoagulation. Aortic valve replacement using the Biocor PSB stentless xenograft offers excellent midterm survival, negligible valve deterioration, and a very low rate of valve-related events, which are comparable to estimates reported with other models of stentless xenografts and currently available stented xenografts. Hemodynamic performance is favorable and

Dynamic tracking of prosthetic valve motion and deformation from bi-plane x-ray views: feasibility study

NASA Astrophysics Data System (ADS)

Hatt, Charles R.; Wagner, Martin; Raval, Amish N.; Speidel, Michael A.

2016-03-01

Transcatheter aortic valve replacement (TAVR) requires navigation and deployment of a prosthetic valve within the aortic annulus under fluoroscopic guidance. To support improved device visualization in this procedure, this study investigates the feasibility of frame-by-frame 3D reconstruction of a moving and expanding prosthetic valve structure from simultaneous bi-plane x-ray views. In the proposed method, a dynamic 3D model of the valve is used in a 2D/3D registration framework to obtain a reconstruction of the valve. For each frame, valve model parameters describing position, orientation, expansion state, and deformation are iteratively adjusted until forward projections of the model match both bi-plane views. Simulated bi-plane imaging of a valve at different signal-difference-to-noise ratio (SDNR) levels was performed to test the approach. 20 image sequences with 50 frames of valve deployment were simulated at each SDNR. The simulation achieved a target registration error (TRE) of the estimated valve model of 0.93 +/- 2.6 mm (mean +/- S.D.) for the lowest SDNR of 2. For higher SDNRs (5 to 50) a TRE of 0.04 mm +/- 0.23 mm was achieved. A tabletop phantom study was then conducted using a TAVR valve. The dynamic 3D model was constructed from high resolution CT scans and a simple expansion model. TRE was 1.22 +/- 0.35 mm for expansion states varying from undeployed to fully deployed, and for moderate amounts of inter-frame motion. Results indicate that it is feasible to use bi-plane imaging to recover the 3D structure of deformable catheter devices.

Dynamic tracking of prosthetic valve motion and deformation from bi-plane x-ray views: feasibility study.

PubMed

Hatt, Charles R; Wagner, Martin; Raval, Amish N; Speidel, Michael A

2016-01-01

Transcatheter aortic valve replacement (TAVR) requires navigation and deployment of a prosthetic valve within the aortic annulus under fluoroscopic guidance. To support improved device visualization in this procedure, this study investigates the feasibility of frame-by-frame 3D reconstruction of a moving and expanding prosthetic valve structure from simultaneous bi-plane x-ray views. In the proposed method, a dynamic 3D model of the valve is used in a 2D/3D registration framework to obtain a reconstruction of the valve. For each frame, valve model parameters describing position, orientation, expansion state, and deformation are iteratively adjusted until forward projections of the model match both bi-plane views. Simulated bi-plane imaging of a valve at different signal-difference-to-noise ratio (SDNR) levels was performed to test the approach. 20 image sequences with 50 frames of valve deployment were simulated at each SDNR. The simulation achieved a target registration error (TRE) of the estimated valve model of 0.93 ± 2.6 mm (mean ± S.D.) for the lowest SDNR of 2. For higher SDNRs (5 to 50) a TRE of 0.04 mm ± 0.23 mm was achieved. A tabletop phantom study was then conducted using a TAVR valve. The dynamic 3D model was constructed from high resolution CT scans and a simple expansion model. TRE was 1.22 ± 0.35 mm for expansion states varying from undeployed to fully deployed, and for moderate amounts of inter-frame motion. Results indicate that it is feasible to use bi-plane imaging to recover the 3D structure of deformable catheter devices.

Valve-sparing aortic root replacement in bicuspid aortic valves: a reasonable option?

PubMed

Aicher, Diana; Langer, Frank; Kissinger, Anke; Lausberg, Henning; Fries, Roland; Schäfers, Hans-Joachim

2004-11-01

Aortic dilatation occurs in many patients with bicuspid aortic valves. We have added root replacement using the remodeling technique originally designed for tricuspid aortic valves to bicuspid aortic valve repair for treatment of the dilated root. We compared the results of remodeling in bicuspid aortic valves with those in tricuspid aortic valves. From October 1995 through January 2004, 60 patients underwent root remodeling for bicuspid aortic valves (group A), and 130 patients underwent root remodeling for tricuspid aortic valves (group B). Correction of cusp prolapse was more often performed in group A (group A, 50/60; group B, 47/130; P < .0001). Transthoracic echocardiography was performed at 1 week, 6 and 12 months, and every year thereafter. Cumulative follow-up was 527 patient-years (mean, 2.9 +/- 2 years). No patient died in group A. Hospital mortality in group B was 5% (5/100; 95% confidence interval,1.6%-11.3%) after elective operations and 10% (3/30; 95% confidence interval, 2.1%-26.5%) after emergency operations. Mean systolic gradients were identical at 1 year (group A, 4.8 +/- 2.1 mm Hg; group B, 4.0 +/- 2 mm Hg) and 5 years (group A, 4.5 +/- 2.3 mm Hg; group B, 3.9 +/- 2.2 mm Hg). Freedom from aortic regurgitation of grade 2 or higher at 5 years was 96% in group A and 83% in group B ( P = .07), and freedom from reoperation at 5 years was 98% in group A and 98% in group B ( P = .73). Valve-sparing aortic replacement with root remodeling can be applied to aortic dilatation and a regurgitant bicuspid aortic valve. Hemodynamic function and valve stability of a repaired bicuspid aortic valve are comparable with those seen in cases of tricuspid anatomy.

Impact of pre-existing or new-onset atrial fibrillation on 30-day clinical outcomes following transcatheter aortic valve replacement: Results from the BRAVO 3 randomized trial.

PubMed

Hengstenberg, Christian; Chandrasekhar, Jaya; Sartori, Samantha; Lefevre, Thierry; Mikhail, Ghada; Meneveau, Nicolas; Tron, Christophe; Jeger, Raban; Kupatt, Christian; Vogel, Birgit; Farhan, Serdar; Sorrentino, Sabato; Sharma, Madhav; Snyder, Clayton; Husser, Oliver; Boekstegers, Peter; Hambrecht, Rainer; Widder, Julian; Hildick-Smith, David; De Carlo, Marco; Wijngaard, Peter; Deliargyris, Efthymios; Bernstein, Debra; Baber, Usman; Mehran, Roxana; Anthopoulos, Prodromos; Dangas, George

2017-11-15

Prior studies have suggested that patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR) are at higher risk for adverse cardiovascular events. Whether procedural bivalirudin compared with unfractionated heparin (UFH) has a beneficial effect on early outcomes in these patients is unknown. We examined for the effect of baseline or new-onset AF within 30 days of TAVR and explored for the effect of bivalirudin versus UFH by AF status, on 30-day outcomes from the BRAVO 3 trial. The BRAVO-3 trial multicenter randomized trial included 802 patients undergoing transfemoral TAVR randomized to bivalirudin or UFH. We compared AF and no-AF groups and examined for 30-day Bleeding Academic Research Consortium type ≥3b bleeding, major vascular complications and all ischemic endpoints. Adjusted outcomes were analyzed using logistic regression methods. Of the study population, 41.4% (n = 332) patients had baseline or new-onset AF within 30 days of TAVR, whereas 58.6% (n = 470) had no AF. Patients with AF had greater prevalence of renal dysfunction, lower left ventricular ejection fraction, and higher euroSCORE I compared with their counterparts without AF. Among AF and no-AF patients, there were no significant baseline differences between bivalirudin and UFH groups. At 30 days the incidence of death (6.0 vs. 4.5%, P = 0.324) and stroke (3.9 vs. 2.6%, P = 0.274) was similar in AF vs. no-AF patients. However, new-onset AF (n = 38) was associated with significantly greater crude risk of 30-day stroke compared with no AF (HR 4.49, 95% CI 1.37-14.67). Regardless of AF status, there were no differences in 30-day death (P-int = 0.652) or stroke (P-int = 0.066) by anticoagulation type. Prior or new-onset AF is noted in more than one-third of patients undergoing transfemoral TAVR. Despite greater baseline comorbidities than non-AF patients, AF was not associated with significantly higher risk of adjusted 30-day outcomes

Aorta-atria-septum combined incision for aortic valve re-replacement

PubMed Central

Xu, Yiwei; Ye, Xiaofeng; Li, Zhaolong

2018-01-01

This case report illustrates a patient who underwent supra-annular mechanical aortic valve replacement then suffered from prosthesis dysfunction, increasing pressure gradient with aortic valve. She was successfully underwent aortic valve re-replacement, sub-annular pannus removing and aortic annulus enlargement procedures through combined cardiac incision passing through aortic root, right atrium (RA), and upper atrial septum. This incision provides optimal visual operative field and simplifies dissection. PMID:29850170

77 FR 53202 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-31

... efficacy of the TAVR technologies for the treatment of aortic stenosis. The data will also include the... surveillance of the quality, safety and efficacy of new medical devices to treat aortic stenosis. For purposes... Determination (NCD) entitled, ``Transcatheter Aortic Valve Replacement (TAVR)''. The TAVR device is only covered...

Aortic valve insufficiency in the teenager and young adult: the role of prosthetic valve replacement.

PubMed

Bradley, Scott M

2013-10-01

The contents of this article were presented in the session "Aortic insufficiency in the teenager" at the congenital parallel symposium of the 2013 Society of Thoracic Surgeons (STS) annual meeting. The accompanying articles detail the approaches of aortic valve repair and the Ross procedure.(1,2) The current article focuses on prosthetic valve replacement. For many young patients requiring aortic valve surgery, either aortic valve repair or a Ross procedure provides a good option. The advantages include avoidance of anticoagulation and potential for growth. In other patients, a prosthetic valve is an appropriate alternative. This article discusses the current state of knowledge regarding mechanical and bioprosthetic valve prostheses and their specific advantages relative to valve repair or a Ross procedure. In current practice, young patients requiring aortic valve surgery frequently undergo valve replacement with a prosthetic valve. In STS adult cardiac database, among patients ≤30 years of age undergoing aortic valve surgery, 34% had placement of a mechanical valve, 51% had placement of a bioprosthetic valve, 9% had aortic valve repair, and 2% had a Ross procedure. In the STS congenital database, among patients 12 to 30 years of age undergoing aortic valve surgery, 21% had placement of a mechanical valve, 18% had placement of a bioprosthetic valve, 30% had aortic valve repair, and 24% had a Ross procedure. In the future, the balance among these options may be altered by design improvements in prosthetic valves, alternatives to warfarin, the development of new patch materials for valve repair, and techniques to avoid Ross autograft failure.

Factors influencing mortality after bioprosthetic valve replacement; a midterm outcome.

PubMed

Javadzadegan, Hassan; Javadzadegan, Amir; Mehdizadeh Baghbani, Jafar

2013-01-01

Although valve repair is applied routinely nowadays, particularly for mitral regurgitation (MR) or tricuspid regurgitation (TR), valve replacement using prosthetic valves is also common especially in adults. Unfortunately the valve with ideal hemodynamic performance and long-term durability without increasing the risk of bleeding due to long-term anticoagulant therapy has not been introduced. Therefore, patients and physicians must choose either bioprosthetic or mechanical valves. Currently, there is an increasing clinical trend of using bioprosthetic valves instead of mechanical valves even in young patients apparently because of their advantages. Seventy patients undergone valvular replacement using bioprosthetic valves were evaluated by ECG and Echocardiography to assess the rhythm and ejection fracture. Mean follow-up time was 33 months (min 9, max 92). Mortality rate was 25.9% (n=18) within 8 years of follow-up. Statistical analysis showed a significant relation between atrial fibrillation rhythm and mortality (P=0.02). Morbidities occurred in 30 patients (42.8%). Significant statistical relation was found between the morbidities and age over 65 years old (P=0.005). In follow-up period, 4 cases (5.7%) underwent re-operation due to global valve dysfunction. Our study shows that using biprosthetic valve could reduce the risk of morbidity occurrence in patient who needs valve replacement. However, if medical treatments fail, patients should be referred for surgery. This would reduce the risk of mortality because of lower incident of complications such as atrial fibrillation and morbidities due to younger patients' population.

Missed aortic valve endocarditis resulting in complete atrioventricular block and redo mechanical valve replacement.

PubMed

Harky, Amer; Garner, Megan; Popa, Miruna; Shipolini, Alex

2017-08-03

Infective endocarditis is a rare disease associated with high morbidity and mortality. As a result, early diagnosis and prompt antibiotic treatment with or without surgical intervention is crucial in the management of such condition.We report a case of missed infective endocarditis of the aortic valve. The patient underwent mechanical aortic valve replacement, with the native valve being sent for histopathological examination. On re-admission 16 months later, he presented with syncope, shortness of breathing and complete heart block. On review of the histopathology of native aortic valve, endocarditis was identified which had not been acted on. The patient underwent redo aortic valve replacement for severe aortic regurgitation.We highlight the importance of following up histopathological results as well as the need for multidisciplinary treatment of endocarditis with a combination of surgical and antibiotic therapy. © BMJ Publishing Group Ltd (unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Complementary role of cardiac CT in the assessment of aortic valve replacement dysfunction

PubMed Central

Moss, Alastair J; Dweck, Marc R; Dreisbach, John G; Williams, Michelle C; Mak, Sze Mun; Cartlidge, Timothy; Nicol, Edward D; Morgan-Hughes, Gareth J

2016-01-01

Aortic valve replacement is the second most common cardiothoracic procedure in the UK. With an ageing population, there are an increasing number of patients with prosthetic valves that require follow-up. Imaging of prosthetic valves is challenging with conventional echocardiographic techniques making early detection of valve dysfunction or complications difficult. CT has recently emerged as a complementary approach offering excellent spatial resolution and the ability to identify a range of aortic valve replacement complications including structural valve dysfunction, thrombus development, pannus formation and prosthetic valve infective endocarditis. This review discusses each and how CT might be incorporated into a multimodal cardiovascular imaging pathway for the assessment of aortic valve replacements and in guiding clinical management. PMID:27843568

Aortic valve replacement for Libman-Sacks endocarditis

PubMed Central

Keenan, Jack B; Janardhanan, Rajesh; Larsen, Brandon T; Khalpey, Zain

2016-01-01

A 24-year-old man with systemic lupus erythematosus and antiphospholipid syndrome complicated by lupus nephritis presented with acute limb ischaemia secondary to an embolus. Following embolectomy, the patient underwent a transthoracic echocardiogram which revealed a large vegetation on all three cusps of the aortic valve. The patient was taken for an urgent aortic valve replacement with a mechanical valve. Cultures of one cusp remained sterile. Histopathological examination of the remaining two cusps revealed sterile fibrin-rich thrombotic vegetations characteristic of non-bacterial thrombotic endocarditis. PMID:27702929

A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in "real-world" patients with aortic stenosis and intermediate- to high-risk profile.

PubMed

Muneretto, Claudio; Alfieri, Ottavio; Cesana, Bruno Mario; Bisleri, Gianluigi; De Bonis, Michele; Di Bartolomeo, Roberto; Savini, Carlo; Folesani, Gianluca; Di Bacco, Lorenzo; Rambaldini, Manfredo; Maureira, Juan Pablo; Laborde, Francois; Tespili, Maurizio; Repossini, Alberto; Folliguet, Thierry

2015-12-01

We sought to investigate the clinical outcomes of patients with isolated severe aortic stenosis and an intermediate- to high-risk profile treated by means of conventional surgery (surgical aortic valve replacement), sutureless valve implantation, or transcatheter aortic valve replacement in a multicenter evaluation. Among 991 consecutive patients with isolated severe aortic stenosis and an intermediate- to high-risk profile (Society of Thoracic Surgeons score >4 and logistic European System for Cardiac Operative Risk Evaluation I >10), a propensity score analysis was performed on the basis of the therapeutic strategy: surgical aortic valve replacement (n = 204), sutureless valve implantation (n = 204), and transcatheter aortic valve replacement (n = 204). Primary end points were 30-day mortality and overall survival at 24-month follow-up; the secondary end point was survival free from a composite end point of major adverse cardiac events (defined as cardiac-related mortality, myocardial infarction, cerebrovascular accidents, and major hemorrhagic events) and periprosthetic regurgitation greater than 2. Thirty-day mortality was significantly higher in the transcatheter aortic valve replacement group (surgical aortic valve replacement = 3.4% vs sutureless = 5.8% vs transcatheter aortic valve replacement = 9.8%; P = .005). The incidence of postprocedural was 3.9% in asurgical aortic valve replacement vs 9.8% in sutureless vs 14.7% in transcatheter aortic valve replacement (P< .001) and peripheral vascular complications occurred in 0% of surgicalaortic valve replacement vs 0% of sutureless vs 9.8% transcatheter aortic valve replacement (P< .001). At 24-month follow-up, overall survival (surgical aortic valve replacement = 91.3% ± 2.4% vs sutureless = 94.9% ± 2.1% vs transcatheter aortic valve replacement = 79.5% ± 4.3%; P < .001) and survival free from the composite end point of major adverse cardiovascular events and periprosthetic regurgitation were significantly

Factors Influencing Mortality after Bioprosthetic Valve Replacement; A Midterm Outcome

PubMed Central

Javadzadegan, Hassan; Javadzadegan, Amir; Mehdizadeh Baghbani, Jafar

2013-01-01

Introduction: Although valve repair is applied routinely nowadays, particularly for mitral regurgitation (MR) or tricuspid regurgitation (TR), valve replacement using prosthetic valves is also common especially in adults. Unfortunately the valve with ideal hemodynamic performance and long-term durability without increasing the risk of bleeding due to long-term anticoagulant therapy has not been introduced. Therefore, patients and physicians must choose either bioprosthetic or mechanical valves. Currently, there is an increasing clinical trend of using bioprosthetic valves instead of mechanical valves even in young patients apparently because of their advantages. Methods: Seventy patients undergone valvular replacement using bioprosthetic valves were evaluated by ECG and Echocardiography to assess the rhythm and ejection fracture. Mean follow-up time was 33 months (min 9, max 92). Results: Mortality rate was 25.9% (n=18) within 8 years of follow-up. Statistical analysis showed a significant relation between atrial fibrillation rhythm and mortality (P=0.02). Morbidities occurred in 30 patients (42.8%). Significant statistical relation was found between the morbidities and age over 65 years old (P=0.005). In follow-up period, 4 cases (5.7%) underwent re-operation due to global valve dysfunction. Conclusion: Our study shows that using biprosthetic valve could reduce the risk of morbidity occurrence in patient who needs valve replacement. However, if medical treatments fail, patients should be referred for surgery. This would reduce the risk of mortality because of lower incident of complications such as atrial fibrillation and morbidities due to younger patients' population. PMID:24404348

Aortic valve replacement for Libman-Sacks endocarditis.

PubMed

Keenan, Jack B; Janardhanan, Rajesh; Larsen, Brandon T; Khalpey, Zain

2016-10-04

A 24-year-old man with systemic lupus erythematosus and antiphospholipid syndrome complicated by lupus nephritis presented with acute limb ischaemia secondary to an embolus. Following embolectomy, the patient underwent a transthoracic echocardiogram which revealed a large vegetation on all three cusps of the aortic valve. The patient was taken for an urgent aortic valve replacement with a mechanical valve. Cultures of one cusp remained sterile. Histopathological examination of the remaining two cusps revealed sterile fibrin-rich thrombotic vegetations characteristic of non-bacterial thrombotic endocarditis. 2016 BMJ Publishing Group Ltd.

Valve Repair Is Superior to Replacement in Most Patients With Coexisting Degenerative Mitral Valve and Coronary Artery Diseases.

PubMed

Javadikasgari, Hoda; Gillinov, A Marc; Idrees, Jay J; Mihaljevic, Tomislav; Suri, Rakesh M; Raza, Sajjad; Houghtaling, Penny L; Svensson, Lars G; Navia, José L; Mick, Stephanie L; Desai, Milind Y; Sabik, Joseph F; Blackstone, Eugene H

2017-06-01

For mitral regurgitation (MR) from degenerative mitral disease in patients with coexisting coronary artery disease, the appropriate surgical strategy remains controversial. From 1985 to 2011, 1,071 adults (age 70 ± 9.3 years, 77% men) underwent combined coronary artery bypass grafting and either mitral valve repair (n = 872, 81%) or replacement (n=199, 19%) for degenerative MR. Propensity matching (177 patient pairs, 89% of possible matches) was used to compare early outcomes and time-related recurrence of MR after mitral valve repair, mitral valve reoperation, and mortality. Risk factors for death were identified with multivariable, multiphase hazard-function analysis. Patients undergoing valve replacement were older, with more valve calcification and a higher prevalence of preoperative atrial fibrillation and heart failure (all p < .0001). Among matched pairs, mitral replacement versus repair was associated with higher hospital mortality (5.0% vs 1.0%, p = .0001) and more postoperative renal failure (7.0% vs 3.2%, p = .01), reexplorations for bleeding (6.0% vs 3.1%, p = .05), and respiratory failure (14% vs 4.7%, p < .0001). Of matched patients undergoing repair, 18% had MR above 3+ by 5 years. Mitral valve durability was similar between matched groups, but survival at 15 years was 18% after replacement versus 52% after repair. Nomograms from the multivariable equation revealed that in 94% of cases, 10-year survival was calculated to be higher after repair than after replacement. In patients with coexisting degenerative mitral valve and coronary artery diseases, mitral valve repair is expected to confer a long-term survival advantage over replacement despite some recurrence of MR. When feasible, it is the procedure of choice for these patients. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Using Time-Driven Activity-Based Costing as a Key Component of the Value Platform: A Pilot Analysis of Colonoscopy, Aortic Valve Replacement and Carpal Tunnel Release Procedures

PubMed Central

Martin, Jacob A.; Mayhew, Christopher R.; Morris, Amanda J.; Bader, Angela M.; Tsai, Mitchell H.; Urman, Richard D.

2018-01-01

Background Time-driven activity-based costing (TDABC) is a methodology that calculates the costs of healthcare resources consumed as a patient moves along a care process. Limited data exist on the application of TDABC from the perspective of an anesthesia provider. We describe the use of TDABC, a bottom-up costing strategy and financial outcomes for three different medical-surgical procedures. Methods In each case, a multi-disciplinary team created process maps describing the care delivery cycle for a patient encounter using the TDABC methodology. Each step in a process map delineated an activity required for delivery of patient care. The resources (personnel, equipment and supplies) associated with each step were identified. A per minute cost for each resource expended was generated, known as the capacity cost rate, and multiplied by its time requirement. The total cost for an episode of care was obtained by adding the cost of each individual resource consumed as the patient moved along a clinical pathway. Results We built process maps for colonoscopy in the gastroenterology suite, calculated costs of an aortic valve replacement by comparing surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) techniques, and determined the cost of carpal tunnel release in an operating room versus an ambulatory procedure room. Conclusions TDABC is central to the value-based healthcare platform. Application of TDABC provides a framework to identify process improvements for health care delivery. The first case demonstrates cost-savings and improved wait times by shifting some of the colonoscopies scheduled with an anesthesiologist from the main hospital to the ambulatory facility. In the second case, we show that the deployment of an aortic valve via the transcatheter route front loads the costs compared to traditional, surgical replacement. The last case demonstrates significant cost savings to the healthcare system associated with re

Intraoperative echocardiographic detection of regurgitant jets after valve replacement

NASA Technical Reports Server (NTRS)

Morehead, A. J.; Firstenberg, M. S.; Shiota, T.; Qin, J.; Armstrong, G.; Cosgrove, D. M. 3rd; Thomas, J. D.

2000-01-01

BACKGROUND: Paravalvular jets, documented by intraoperative transesophageal echocardiography, have prompted immediate valve explantation by others, yet the significance of these jets is unknown. METHODS: Twenty-seven patients had intraoperative transesophageal two-dimensional color Doppler echocardiography, performed to assess the number and area of regurgitant jets after valve replacement, before and after protamine. Patients were grouped by first time versus redo operation, valve position and type. RESULTS: Before protamine, 55 jets were identified (2.04+/-1.4 per patient) versus 29 jets after (1.07+/-1.2 per patient, p = 0.0002). Total jet area improved from 2.0+/-2.2 cm2 to 0.86+/-1.7 cm2 with protamine (p<0.0001). In all patients jet area decreased (average decrease, 70.7%+/-27.0%). First time and redo operations had similar improvements in jet number and area (both p>0.6). Furthermore, mitral and mechanical valves each had more jets and overall greater jet area when compared to aortic and tissue valves, respectively. CONCLUSIONS: Following valve replacement, multiple jets are detected by intraoperative transesophageal echocardiography. They are more common and larger in the mitral position and with mechanical valves. Improvement occurs with reversal of anticoagulation.

Acquired discrete subaortic stenosis late after mitral valve replacement.

PubMed

Mohan, Jagdish C; Shukla, Madhu; Mohan, Vishwas; Sethi, Arvind

2016-09-01

Although acquired left ventricular outflow obstruction has been reported in a variety of conditions, there are scant reports of its occurrence following mitral valve replacement (MVR). This study describes two female patients, who developed severe discrete subaortic stenosis, five years following MVR. In both cases, the mitral valve was replaced by a porcine Carpentier-Edwards 27-mm bioprosthesis with preservation of mitral valve leaflets. The risk of very late left ventricular outflow tract obstruction after bio-prosthetic MVR with preservation of subvalvular apparatus needs to be kept in mind in symptomatic patients. Copyright © 2016 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Pannus Formation Leads to Valve Malfunction in the Tricuspid Position 19 Years after Triple Valve Replacement.

PubMed

Alskaf, Ebraham; McConkey, Hannah; Laskar, Nabila; Kardos, Attila

2016-06-20

The Medtronic ATS Open Pivot mechanical valve has been successfully used in heart valve surgery for more than two decades. We present the case of a patient who, 19 years following a tricuspid valve replacement with an ATS prosthesis as part of a triple valve operation following infective endocarditis, developed severe tricuspid regurgitation due to pannus formation.

One-year outcomes after rapid-deployment aortic valve replacement.

PubMed

Young, Christopher; Laufer, Günther; Kocher, Alfred; Solinas, Marco; Alamanni, Francesco; Polvani, Gianluca; Podesser, Bruno K; Aramendi, Jose Ignacio; Arribas, Jose; Bouchot, Olivier; Livi, Ugolino; Massetti, Massimo; Terp, Kim; Giot, Christophe; Glauber, Mattia

2018-02-01

The goals of rapid-deployment aortic valve replacement include facilitation of minimally invasive surgery and reduced aortic crossclamp time. We report the short-term outcomes of a series of 493 patients undergoing rapid-deployment aortic valve replacement with the EDWARDS INTUITY valve system (Edwards Lifesciences, LLC, Irvine, Calif). Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study was a prospective, multicenter (n = 26) European registry designed to evaluate the safety and performance of the valve system. During rapid-deployment aortic valve replacement, device technical success and crossclamp time were assessed. Procedural outcomes, hemodynamic performance, and various adverse events and clinical outcomes were evaluated up to 2 years. Between 2012 and 2014, 493 of 517 enrolled patients successfully received implants with the study valve (95.4% technical success). Mean crossclamp times for 163 full sternotomies, 128 mini-upper sternotomies, and 36 right anterior thoracotomies isolated aortic valve replacements were 47.3, 52.0, and 73.3 minutes, respectively. Mean follow-up was 1.8 years, with 870 total patient-years of follow-up. Mean effective orifice area increased from 0.72 (baseline) to 1.88 cm 2 , and mean pressure gradient decreased from 47.6 to 9.6 mm Hg (1 year). Mean effective orifice area index increased (0.39-1.01 cm 2 /m 2 ), and 28 of 287 patients (9.8%) exhibited severe prosthesis-patient mismatch at 1 year. After 1 year, 68.1% and 21.7% of patients were in New York Heart Association class I and II, respectively. Freedom from death, major bleeding, major perivalvular leak, reoperation, and device explant at 1 year were 0.935, 0.939, 0.976, 0.975, and 0.983, respectively. These results demonstrate commendable safety and performance of the test valve system over the short term in a broad European setting. Copyright © 2017 The

Optimal Elastomeric Scaffold Leaflet Shape for Pulmonary Heart Valve Leaflet Replacement

PubMed Central

Fan, Rong; Bayoumi, Ahmed S.; Chen, Peter; Hobson, Christopher M.; Wagner, William R.; Mayer, John E.; Sacks, Michael S.

2012-01-01

Surgical replacement of the pulmonary valve (PV) is a common treatment option for congenital pulmonary valve defects. Engineered tissue approaches to develop novel PV replacements are intrinsically complex, and will require methodical approaches for their development. Single leaflet replacement utilizing an ovine model is an attractive approach in that candidate materials can be evaluated under valve level stresses in blood contact without the confounding effects of a particular valve design. In the present study an approach for optimal leaflet shape design based on finite element (FE) simulation of a mechanically anisotropic, elastomeric scaffold for PV replacement is presented. The scaffold was modeled as an orthotropic hyperelastic material using a generalized Fung-type constitutive model. The optimal shape of the fully loaded PV replacement leaflet was systematically determined by minimizing the difference between the deformed shape obtained from FE simulation and an ex-vivo microCT scan of a native ovine PV leaflet. Effects of material anisotropy, dimensional changes of PV root, and fiber orientation on the resulting leaflet deformation were investigated. In-situ validation demonstrated that the approach could guide the design of the leaflet shape for PV replacement surgery. PMID:23294966

MANAGEMENT OF FAILED MITRAL VALVE REPLACEMENT. THE DURBAN EXPERIENCE.

PubMed

Kistan, D; Booysen, M; Alexander, G; Madiba, T E

2017-06-01

Mitral valve replacement is the procedure of choice in patients with severe mitral valve disease. However, these patients are surviving longer and are thus at an increased risk of prosthesis failure or valve-related complications. Study setting: Inkosi Albert Luthuli Central Hospital, a tertiary referral Hospital in Durban. Study population: All patients undergoing redo mechanical mitral valve replacement surgery between January 2005 and December 2014. Study design: Retrospective analysis of patients undergoing redo mitral valve replacement. Patients were identified from theatre record books, their files were electronically accessed and pertinent information extracted onto a data capture sheet. Information documented included demographics, duration to failure, INR, Albumin, HIV status, clinical findings and outcome. The data was stored on an Excel datasheet. Fifty-eight patients were documented (mean age 32 ± 15.81 years; M:F 1:3). Ten patients (17%) were HIV positive (median CD4 count 478). Mean duration between first surgery and redo was 8.8 years. Thirty-five patients (60%) had no co-morbidities. Presenting features at redo surgery were congestive cardiac failure (27), chest pain (11) and palpitations (17). Mean preoperative Ejection Fraction was 51.65 %. Twenty-nine patients (55%) had emergency redo surgery. Twenty-two patients (75%) had acute prosthetic valve thrombosis. Thirty-two patients had tricuspid regurgitation. Original pathology was documented in 23 patients (40%) as Rheumatic valve disease. Prosthetic valve thrombosis was documented in 31 patients (54%). The most commonly used valve was the On-X. Mean presenting INR was 1.96 + 1.2 and mean presenting serum albumin was 36.7 + 7.8 g/l. Forty-one patients (71%) were found to be compliant to Warfarin therapy prior to redo surgery. Mean ICU stay was 6 +9 days. Two patients died postoperatively. Mean followup was 32 + 26.6 months. Twelve patients (20.7%) developed postoperative complications. Patients

[Pannus Formation Six-years after Aortic and Mitral Valve Replacement with Tissue Valves;Report of a Case].

PubMed

Nakamura, Makoto; Muraoka, Arata; Aizawa, Kei; Akutsu, Hirohiko; Kurumisawa, Soki; Misawa, Yoshio

2015-07-01

A 77-year-old man presented with exertional dyspnea. He had undergone aortic and mitral valve replacement with tissue valves 6-years earlier. The patient's hemoglobin level was 9.8 g/dl and serum aspartate aminotransferase (70 mU/ml) and lactate dehydrogenase (1,112 mU/ml) were elevated. Echocardiography revealed stenosis of the prosthetic valve in the aortic position with peak flow velocity of 3.8 m/second and massive mitral regurgitation. The patient underwent repeat valve replacement. Pannus formation around both implanted valves was observed. The aortic valve orifice was narrowed by the pannus, and one cusp of the prosthesis in the mitral position was fixed and caused the regurgitation, but they were free from cusp laceration or calcification. The patient's postoperative course was uneventful, and he continues to do well 14 months after surgery.

Survival after Aortic Valve Replacement with Bovine or Porcine Valve Prostheses: A Systematic Review and Meta-Analysis.

PubMed

Glaser, Natalie; Jackson, Veronica; Franco-Cereceda, Anders; Sartipy, Ulrik

2018-05-17

 Bovine and porcine bioprostheses are commonly used for surgical aortic valve replacement. It is unknown if the long-term survival differs between the two valve types.We performed a systematic review and meta-analysis to compare survival in patients who underwent aortic valve replacement and received a bovine or a porcine prosthesis.  We performed a systematic search of Medline, Embase, Web of Science, and the Cochrane Library. Cohort studies that compared survival between patients who underwent aortic valve replacement and received either a bovine or a porcine bioprosthesis and that reported overall long-term survival with hazard ratio (HR) and 95% confidence interval (CI) were included. Two authors independently reviewed articles considered for inclusion, extracted the information from each study, and performed the quality assessment. We performed a meta-analysis using a random effects model to calculate the pooled HR (95% CI) for all-cause mortality. We did sensitivity analyses to assess the robustness of our findings.  Seven studies published between 2010 and 2015 were included, and the combined study population was 49,190 patients. Of these, 32,235 (66%) received a bovine, and 16,955 (34%) received a porcine bioprosthesis. There was no significant difference in all-cause mortality between patients who received a bovine compared with a porcine bioprosthesis (pooled HR 1.00, 95% CI: 0.92-1.09). Heterogeneity between studies was moderate (55.8%, p  = 0.04).  This systematic review and meta-analysis suggest no difference in survival between patients who received a bovine versus a porcine bioprosthesis after aortic valve replacement. Our study provides valuable evidence for the continuing use of both bovine and porcine bioprosthetic valves for surgical aortic valve replacement. Georg Thieme Verlag KG Stuttgart · New York.

Late complications in patients with Björk-Shiley and St. Jude Medical heart valve replacement.

PubMed

Horstkotte, D; Körfer, R; Seipel, L; Bircks, W; Loogen, F

1983-09-01

Valve-related complications after Björk-Shiley mitral valve implantation (n = 475), aortic valve implantation (n = 424), or mitral-aortic valve implantation (n = 119) were compared with those after St. Jude Medical mitral valve replacement (n = 173), aortic valve replacement (n = 152), or mitral-aortic valve replacement (n = 69). All patients were placed on anticoagulant therapy with phenprocoumon early after operation. All patients had a comparable follow-up time of approximately 23 months, which showed that cumulative thromboembolic rates were significantly higher after St. Jude valve implantation than after Björk-Shiley valve implantation. Reoperations were necessary because of valve thrombosis (0.46%), perivalvular leakage (2.2%), or prosthetic valve endocarditis with perivalvular regurgitation (0.46%). One Björk-Shiley mitral valve prosthesis had to be replaced because of fracture of the outlet strut. Without significant intergroup differences, hemorrhage due to anticoagulant treatment was the most frequent complication. Thromboembolic complications were significantly more frequent after Björk-Shiley mitral, aortic, and double valve replacements than after St. Jude valve implantation. This may lead to consideration of changes in the prophylaxis of thrombus formations in the St. Jude valve, especially in aortic valve replacements, in patients with sinus rhythm.

Fibrous composite material for textile heart valve design: in vitro assessment.

PubMed

Amri, Amna; Laroche, Gaetan; Chakfe, Nabil; Heim, Frederic

2018-04-17

With over 150,000 implantations performed over the world, transcatheter aortic valve replacement (TAVR) has become a surgical technique, which largely competes with open surgery valve replacement for an increasing number of patients. The success of the procedure favors the research toward synthetic valve leaflet materials as an alternative to biological tissues, whose durability remains unknown. In particular, fibrous constructions have recently proven to be durable in vivo over a 6-month period of time in animal sheep models. Exaggerated fibrotic tissue formation remains, however, a critical issue to be addressed. This work investigates the design of a composite fibrous construction combining a woven polyethylene terephthalate (PET) layer and a non-woven PET mat, which are expected to provide, respectively, strength and appropriate topography toward limited fibrotic tissue ingrowth. For this purpose, a specific equipment has been developed to produce non-woven PET mats made from fibers with small diameter. These mats were assembled with woven PET substrates using various assembling techniques in order to obtain hybrid fibrous constructions. The physical and mechanical properties of the obtained materials were assessed and valve samples were manufactured to be tested in vitro for hydrodynamic performances. The results show that the composite fibrous construction is characterized by properties suitable for the valve leaflet function, but the durability of the assembling is however limited under accelerated cyclic loading.

Tricuspid valve replacement with mechanical prostheses: Short and long-term outcomes.

PubMed

Rossello, Xavier; Muñoz-Guijosa, Christian; Mena, Elisabet; Camprecios, Marta; Mendez, Ana B; Borras, Xavier; Padro, Josep M

2017-09-01

Tricuspid valve replacement has been associated with high mortality and poor long-term outcomes. We report the preoperative risk factors associated with short and long-term outcomes following tricuspid valve replacement with mechanical prostheses. In 62 patients who underwent mechanical tricuspid valve replacement, clinical, laboratory, and echocardiographic findings were analyzed using both univariate and multivariate analyses to describe operative and long-term mortality. In our population (mean age 59 ± 9.7 years, 82.3% female), most common causes of tricuspid valve disease were rheumatic fever (69.4%) and functional regurgitation (19.4%). Operative and long-term mortality were 17.7 and 33.9%, respectively. Age, diabetes mellitus, and coronary artery disease were independently associated with increased long-term mortality. New York Heart Association (NYHA) class and right heart failure symptoms significantly improved during follow-up. In this series of mechanical tricuspid valve replacements in patients with predominately rheumatic heart disease, operative and long-term mortality were increased; however, survivors had significant improvement in their NYHA class and freedom from right heart failure symptoms. Three preoperative factors (age, diabetes mellitus, and coronary artery disease) were independently associated with long-term mortality. © 2017 Wiley Periodicals, Inc.

Inter-ethnic differences in valve morphology, valvular dysfunction, and aortopathy between Asian and European patients with bicuspid aortic valve.

PubMed

Kong, William K F; Regeer, Madelien V; Poh, Kian K; Yip, James W; van Rosendael, Philippe J; Yeo, Tiong C; Tay, Edgar; Kamperidis, Vasileios; van der Velde, Enno T; Mertens, Bart; Ajmone Marsan, Nina; Delgado, Victoria; Bax, Jeroen J

2018-04-14

Transcatheter aortic valve replacement (TAVR) has been shown safe and feasible in patients with bicuspid aortic valve (BAV) morphology. Evaluation of inter-ethnic differences in valve morphology and function and aortic root dimensions in patients with BAV is important for the worldwide spread of this therapy in this subgroup of patients. Comparisons between large European and Asian cohorts of patients with BAV have not been performed, and potential differences between populations may have important implications for TAVR. The present study evaluated the differences in valve morphology and function and aortic root dimensions between two large cohorts of European and Asian patients with BAV. Aortic valve morphology was defined on transthoracic echocardiography according to the number of commissures and raphe: type 0 = no raphe and two commissures, type 1 = one raphe and two commissures, type 2 = two raphes and one commissure. Aortic stenosis and regurgitation were graded according to current recommendations. For this study, aortic root dimensions were manually measured on transthoracic echocardiograms at the level of the aortic annulus, sinus of Valsalva (SOV), sinotubular junction (STJ), and ascending aorta (AA). Of 1427 patients with BAV (45.2 ± 18.1 years, 71.9% men), 794 (55.6%) were Europeans and 633 (44.4%) were Asians. The groups were comparable in age and proportion of male sex. Asians had higher prevalence of type 1 BAV with raphe between right and non-coronary cusps than Europeans (19.7% vs. 13.6%, respectively; P < 0.001), whereas the Europeans had higher prevalence of type 0 BAV (two commissures, no raphe) than Asians (14.5% vs. 6.8%, respectively; P < 0.001). The prevalence of moderate and severe aortic regurgitation was higher in Europeans than Asians (44.2% vs. 26.8%, respectively; P < 0.001) whereas there were no differences in BAV with normal function or aortic stenosis. After adjusting for demographics, comorbidities

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

PubMed

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

2014-08-01

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

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

PubMed Central

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

2014-01-01

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

A dynamic model-based approach to motion and deformation tracking of prosthetic valves from biplane x-ray images.

PubMed

Wagner, Martin G; Hatt, Charles R; Dunkerley, David A P; Bodart, Lindsay E; Raval, Amish N; Speidel, Michael A

2018-04-16

Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure in which a prosthetic heart valve is placed and expanded within a defective aortic valve. The device placement is commonly performed using two-dimensional (2D) fluoroscopic imaging. Within this work, we propose a novel technique to track the motion and deformation of the prosthetic valve in three dimensions based on biplane fluoroscopic image sequences. The tracking approach uses a parameterized point cloud model of the valve stent which can undergo rigid three-dimensional (3D) transformation and different modes of expansion. Rigid elements of the model are individually rotated and translated in three dimensions to approximate the motions of the stent. Tracking is performed using an iterative 2D-3D registration procedure which estimates the model parameters by minimizing the mean-squared image values at the positions of the forward-projected model points. Additionally, an initialization technique is proposed, which locates clusters of salient features to determine the initial position and orientation of the model. The proposed algorithms were evaluated based on simulations using a digital 4D CT phantom as well as experimentally acquired images of a prosthetic valve inside a chest phantom with anatomical background features. The target registration error was 0.12 ± 0.04 mm in the simulations and 0.64 ± 0.09 mm in the experimental data. The proposed algorithm could be used to generate 3D visualization of the prosthetic valve from two projections. In combination with soft-tissue sensitive-imaging techniques like transesophageal echocardiography, this technique could enable 3D image guidance during TAVR procedures. © 2018 American Association of Physicists in Medicine.

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

PubMed

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

2017-06-01

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

Dissection of the atrial wall after mitral valve replacement.

PubMed Central

Lukács, L; Kassai, I; Lengyel, M

1996-01-01

We describe an unusual sequela of mitral valve replacement in a 50-year-old woman who had undergone a closed mitral commissurotomy in 1975. She was admitted to our hospital because of mitral restenosis in November 1993, at which time her mitral valve was replaced with a mechanical prosthesis. On the 8th postoperative day, the patient developed symptoms of heart failure; transesophageal echocardiography revealed dissection and rupture of the left atrial wall. At prompt reoperation, we found an interlayer dissection and rupture of the atrial wall into the left atrium. We repaired the ruptured atrial wall with a prosthetic patch. The postoperative course was uneventful, and postoperative transesophageal echocardiography showed normal prosthetic valve function and no dissection. Images PMID:8680278

[Late complications following Björk-Shiley and St. Jude Medical heart valve replacement].

PubMed

Horstkotte, D; Körfer, R; Budde, T; Haerten, K; Schulte, H D; Bircks, W; Loogen, F

1983-05-01

Valve-related complications after Björk-Shiley mitral (n = 475), aortic (n = 424), or mitral-aortic implantation (n = 119) were compared to complications after St. Jude mitral (n = 173), aortic (n = 152), and St. Jude mitral and aortic (n = 63) replacements. The 1,018 consecutive patients with Björk-Shiley valves had been operated upon between 1974 and 1982, those with St. Jude valves between 1978 and 1982. All patients were placed on anticoagulant therapy with phenprocoumon early after operation and no significant intergroup differences in the effectiveness of the anticoagulant therapy were found. At a comparable follow-up time of approximately 23 months, 24 major thromboembolic episodes were observed after Björk-Shiley mitral (BSM) and 3 after St. Jude mitral valve implantation (SJM), corresponding to a thromboembolic rate of 2.82/100 patient years with BSM and 0.93/100 patient years with SJM. After aortic valve replacements, 1.93 events in 100 patient years occurred after Björk-Shiley aortic (BSA) and 0.73 after St. Jude aortic implantation (SJA). In patients with double valve replacements, these rates were 3.2 (BSM + BSA) and 0.88 (SJM + SJA), respectively. The cerebral vessels were involved in 52% and the arteries of the extremities in 22% of these major events. Six Björk-Shiley prostheses had to be replaced because of valve thrombosis. The overall incidence of severe hemorrhagic complications was 2.94/100 patient years in BSM and 1.79 in SJM. After aortic valve replacement, we found rates of 1.80/100 patient years (BSA) and 2.57/100 patient years (SJA), respectively. Intravascular hemolysis no longer seems to be a significant clinical problem. However, indications of red cell damage after heart valve replacement were significantly greater in patients with perivalvular leakage, valve thrombosis, or dysfunction than in those with normally functioning prostheses. Reoperations were necessary because of valve thrombosis (0.46%), perivalvular leakage (2

Pledget Induced Cardiogenic Shock Following a Minimally Invasive Aortic Valve Replacement.

PubMed

Tedesco, Alexandra E; Tedesco, Victor E

2017-01-01

Within the last decade, minimally invasive valve replacements have become exceedingly popular, and as a result, so has the rise of technology aimed at refining and simplifying these techniques. With new technology, new complications are inevitable. We present a routine Minimally invasive aortic valve replacement through a right anterior minithoracotomy complicated by pledget impaction in a coronary artery.

Haemodynamic results of replacement of mitral and aortic valves with autologous fascia lata prostheses

PubMed Central

Talavlikar, P. H.; Walbaum, P. R.; Kitchin, A. H.

1973-01-01

Twelve patients undergoing aortic and 28 undergoing mitral valve replacement with autologous fascia lata valves were studied before and six months after surgery. One aortic and 10 mitral valves were found to be significantly incompetent. Of the incompetent mitral valves, two appeared to have perivalvular leaks. Six of the remainder were associated with abnormal ventricular filling patterns. Valve failure was much less common when the design was modified to provide a loose cusp structure; out of 12 such valves none was incompetent. Transvalvular gradients persist with fascial valves though they are lower than with most mechanical prostheses. Ventricular function was greatly improved in successful aortic replacement but remained impaired in the case of mitral replacement. Valve failure appeared to be associated with, or accelerated by, haemodynamic stress rather than due to inevitable degenerative pathological processes. PMID:4731108

Percutaneous transluminal alcohol septal myocardial ablation after aortic valve replacement

NASA Technical Reports Server (NTRS)

Sitges, M.; Kapadia, S.; Rubin, D. N.; Thomas, J. D.; Tuzcu, M. E.; Lever, H. M.

2001-01-01

When left ventricular outflow tract obstruction develops after aortic valve replacement, few treatment choices have been available until now. We present a patient with prior aortic valve replacement who developed left ventricle outflow tract obstruction that was successfully treated with a percutaneous transcoronary myocardial septal alcohol ablation. This technique is a useful tool for the treatment of obstructive hypertrophic cardiomyopathy, especially in those patients with prior heart surgery. Copyright 2001 Wiley-Liss, Inc.

Prosthetic Aortic Valve Fixation Study: 48 Replacement Valves Analyzed Using Digital Pressure Mapping.

PubMed

Lee, Candice Y; Wong, Joshua K; Ross, Ronald E; Liu, David C; Khabbaz, Kamal R; Martellaro, Angelo J; Gorea, Heather R; Sauer, Jude S; Knight, Peter A

Prostheses attachment is critical in aortic valve replacement surgery, yet reliable prosthetic security remains a challenge. Accurate techniques to analyze prosthetic fixation pressures may enable the use of fewer sutures while reducing the risk of paravalvular leaks (PVL). Customized digital thin film pressure transducers were sutured between aortic annulus models and 21-mm bioprosthetic valves with 15 × 4-mm, 12 × 4-mm, or 9 × 6-mm-wide pledgeted mattress sutures. Simulating open and minimally invasive access, 4 surgeons, blinded to data acquisition, each secured 12 valves using manual knot-tying (hand-tied [HT] or knot-pusher [KP]) or automated titanium fasteners (TFs). Real-time pressure measurements and times were recorded. Two-dimensional (2D) and 3D pressure maps were generated for all valves. Pressures less than 80 mm Hg were considered at risk for PVL. Pressures under each knot (intrasuture) fell less than 80 mm Hg for 12 of 144 manual knots (5/144 HT, 7/144 KP) versus 0 of 288 TF (P < 0.001). Pressures outside adjacent sutures (extrasuture) were less than 80 mm Hg in 10 of 60 HT, zero of 60 KP, and zero of 120 TF sites for 15 × 4-mm valves; 17 of 48 HT, 25 of 48 KP, and 12 of 96 TF for 12 × 4-mm valves; and 15 of 36 HT, 17 of 36 KP, and 9 and 72 TF for 9 × 6-mm valves; P < 0.001 all manual versus TF. Annular areas with pressures less than 80 mm Hg ranged from 0% of the sewing-ring area (all open TF) to 31% (12 × 4 mm, KP). The average time per manual knot, 46 seconds (HT, 31 seconds; KP, 61 seconds), was greater than TF, 14 seconds (P < 0.005). Reduced operative times and PVL risk would fortify the advantages of surgical aortic valve replacement. This research encourages continued exploration of technical factors in optimizing prosthetic valve security.

Valve-sparing aortic root replacement in Loeys-Dietz syndrome.

PubMed

Patel, Nishant D; Arnaoutakis, George J; George, Timothy J; Allen, Jeremiah G; Alejo, Diane E; Dietz, Harry C; Cameron, Duke E; Vricella, Luca A

2011-08-01

Loeys-Dietz syndrome (LDS) is a recently recognized aggressive aortic disorder characterized by root aneurysm, arterial tortuosity, hypertelorism, and bifid uvula or cleft palate. The results of prophylactic root replacement using valve-sparing procedures (valve-sparing root replacement [VSRR]) in patients with LDS is not known. We reviewed all patients with clinical and genetic (transforming growth factor-β receptor mutations) evidence of LDS who underwent VSRR at our institution. Echocardiographic and clinical data were obtained from hospital and follow-up clinic records. From 2002 to 2009, 31 patients with a firm diagnosis of LDS underwent VSRR for aortic root aneurysm. Mean age was 15 years, and 24 (77%) were children. One (3%) patient had a bicuspid aortic valve. Preoperative sinus diameter was 3.9±0.8 cm (z score 7.0±2.9) and 2 (6%) had greater than 2+ aortic insufficiency. Thirty patients (97%) underwent reimplantation procedures using a Valsalva graft. There were no operative deaths. Mean follow-up was 3.6 years (range, 0 to 7 years). One patient required late repair of a pseudoaneurysm at the distal aortic anastomosis, and 1 had a conversion to a David reimplantation procedure after a Florida sleeve operation. No patient suffered thromboembolism or endocarditis, and 1 (3%) patient experienced greater than 2+ late aortic insufficiency. No patient required late aortic valve repair or replacement. Loeys-Dietz syndrome is an aggressive aortic aneurysm syndrome that can be addressed by prophylactic aortic root replacement with low operative risk. Valve-sparing procedures have encouraging early and midterm results, similar to those in Marfan syndrome, and are an attractive option for young patients. Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

In Vitro Evaluation of a Novel Hemodynamically Optimized Trileaflet Polymeric Prosthetic Heart Valve

PubMed Central

Claiborne, Thomas E.; Sheriff, Jawaad; Kuetting, Maximilian; Steinseifer, Ulrich; Slepian, Marvin J.; Bluestein, Danny

2013-01-01

Calcific aortic valve disease is the most common and life threatening form of valvular heart disease, characterized by stenosis and regurgitation, which is currently treated at the symptomatic end-stages via open-heart surgical replacement of the diseased valve with, typically, either a xenograft tissue valve or a pyrolytic carbon mechanical heart valve. These options offer the clinician a choice between structural valve deterioration and chronic anticoagulant therapy, respectively, effectively replacing one disease with another. Polymeric prosthetic heart valves (PHV) offer the promise of reducing or eliminating these complications, and they may be better suited for the new transcatheter aortic valve replacement (TAVR) procedure, which currently utilizes tissue valves. New evidence indicates that the latter may incur damage during implantation. Polymer PHVs may also be incorporated into pulsatile circulatory support devices such as total artificial heart and ventricular assist devices that currently employ mechanical PHVs. Development of polymer PHVs, however, has been slow due to the lack of sufficiently durable and biocompatible polymers. We have designed a new trileaflet polymer PHV for surgical implantation employing a novel polymer—xSIBS—that offers superior bio-stability and durability. The design of this polymer PHV was optimized for reduced stresses, improved hemodynamic performance, and reduced thrombogenicity using our device thrombogenicity emulation (DTE) methodology, the results of which have been published separately. Here we present our new design, prototype fabrication methods, hydrodynamics performance testing, and platelet activation measurements performed in the optimized valve prototype and compare it to the performance of a gold standard tissue valve. The hydrodynamic performance of the two valves was comparable in all measures, with a certain advantage to our valve during regurgitation. There was no significant difference between the

The value of aortic valve replacement in elderly patients: an economic analysis.

PubMed

Wu, YingXing; Grunkemeier, Gary L; Starr, Albert

2007-03-01

Economists have designed frameworks to measure the economic value of improvements in health and longevity. Heart valve replacement surgery has significantly prolonged life expectancy and quality of life. For the example of aortic valve replacement, what is its economic value according to this framework? From 1961 through 2003, a total of 4617 adult patients underwent aortic valve replacement by one team of cardiac surgeons. These patients were provided with a prospective lifetime follow-up service. As of 2005, observed follow-up was 31,671 patient-years, with a maximum of 41 years. A statistical model was used to generate the future life-years of patients currently alive. The value of life-years proposed by economists was applied to determine the economic value of the additional life given to these patients by aortic valve replacement. The total life-years after aortic valve replacement were 53,323, with a gross value of 14.6 billion dollars. The total expected life-years without surgery were 10,157, with an estimated value of 3.0 billion dollars. Thus the net life-years gained by AVR were 43,166, worth 11.6 billion dollars. Subtracting the 451 million dollars total lifetime cost of surgery, the net value of the life-years gained by AVR was 11.2 billion dollars. The mean net value decreases according to age at surgery but is still worth 600,000 dollars for octogenarians and 200,000 dollars for nonagenarians. According to the economic concept of the value of a statistical life, the return on the investment for aortic valve replacement is enormous for patients of all ages, even very elderly patients.

Earlier Pulmonary Valve Replacement in Down Syndrome Patients Following Tetralogy of Fallot Repair.

PubMed

Sullivan, Rachel T; Frommelt, Peter C; Hill, Garick D

2017-08-01

The association between Down syndrome and pulmonary hypertension could contribute to more severe pulmonary regurgitation after tetralogy of Fallot repair and possibly earlier pulmonary valve replacement. We compared cardiac magnetic resonance measures of pulmonary regurgitation and right ventricular dilation as well as timing of pulmonary valve replacement between those with and without Down syndrome after tetralogy of Fallot repair. Review of our surgical database from 2000 to 2015 identified patients with tetralogy of Fallot with pulmonary stenosis. Those with Down syndrome were compared to those without. The primary outcome of interest was time from repair to pulmonary valve replacement. Secondary outcomes included pulmonary regurgitation and indexed right ventricular volume on cardiac magnetic resonance imaging. The cohort of 284 patients included 35 (12%) with Down syndrome. Transannular patch repair was performed in 210 (74%). Down syndrome showed greater degree of pulmonary regurgitation (55 ± 14 vs. 37 ± 16%, p = 0.01) without a significantly greater rate of right ventricular dilation (p = 0.09). In multivariable analysis, Down syndrome (HR 2.3, 95% CI 1.2-4.5, p = 0.02) and transannular patch repair (HR 5.5, 95% CI 1.7-17.6, p = 0.004) were significant risk factors for valve replacement. Those with Down syndrome had significantly lower freedom from valve replacement (p = 0.03). Down syndrome is associated with an increased degree of pulmonary regurgitation and earlier pulmonary valve replacement after tetralogy of Fallot repair. These patients require earlier assessment by cardiac magnetic resonance imaging to determine timing of pulmonary valve replacement and evaluation for and treatment of preventable causes of pulmonary hypertension.

Long-Term Mortality Effect of Early Pacemaker Implantation After Surgical Aortic Valve Replacement.

PubMed

Greason, Kevin L; Lahr, Brian D; Stulak, John M; Cha, Yong-Mei; Rea, Robert F; Schaff, Hartzell V; Dearani, Joseph A

2017-10-01

The need for pacemaker implantation is a well-described complication of aortic valve replacement. Not so well described is the effect such an event has on long-term outcome. This study reviewed a 21-year experience at the Mayo Clinic (Rochester, Minnesota) with aortic valve replacement to understand the influence of early postoperative pacemaker implantation on long-term mortality rates more clearly. This study retrospectively reviewed the records of 5,842 patients without previous pacemaker implantation who underwent surgical aortic valve replacement from January 1993 through June 2014. The median age of these patients was 73 years (range, 65 to 79 years), the median ejection fraction was 62% (range, 53% to 68%), 3,853 patients were male (66%), and coronary artery bypass graft operation was performed in 2,553 (44%) of the patients studied. Early pacemaker implantation occurred in 146 patients (2.5%) within 30 days of surgical aortic valve replacement. The median follow-up of patients was 11.1 years (range, 5.8 to 16.5 years), and all-cause mortality rates were 2.4% at 30 days, 6.4% at 1 year, 23.1% at 5 years, 48.3% at 10 years, and 67.9% at 15 years postoperatively. Early pacemaker implantation was associated with an increased risk of death after multivariable adjustment for baseline patients' characteristics (hazard ratio, 1.49; 95% confidence interval, 1.20, 1.84; p < 0.001). Early pacemaker implantation as a complication of surgical aortic valve replacement is associated with an increased risk of long-term death. Valve replacement-related pacemaker implantation rates should be important considerations with respect to new valve replacement paradigms, especially in younger and lower-risk patients. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Aortic valve replacement for aortic stenosis caused by alkaptonuria.

PubMed

Hiroyoshi, Junko; Saito, Aya; Panthee, Nirmal; Imai, Yasushi; Kawashima, Dai; Motomura, Noboru; Ono, Minoru

2013-03-01

We report a case of aortic stenosis associated with ochronosis in a 70-year-old man who underwent biologic aortic valve replacement. Intraoperative findings included ochronosis of a severely calcified pigmented aortic valve along with pigmentation of the intima of the aorta. Copyright © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2018-05-20

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

Patch enlargement of the aortic and mitral valve rings with aortic and mitral double valve replacement. Experimental study.

PubMed

Manouguian, S; Abu-Aishah, N; Neitzel, J

1979-09-01

The experimental results of patch enlargement of the aortic and mitral valve rings with aortic and mitral double valve replacement are reported. The operative technique of this new surgical method is described and the indications are discussed.

Cost-effectiveness of aortic valve replacement in the elderly: an introductory study.

PubMed

Wu, YingXing; Jin, Ruyun; Gao, Guangqiang; Grunkemeier, Gary L; Starr, Albert

2007-03-01

With increased life expectancy and improved technology, valve replacement is being offered to increasing numbers of elderly patients with satisfactory clinical results. By using standard econometric techniques, we estimated the relative cost-effectiveness of aortic valve replacement by drawing on a large prospective database at our institution. By using aortic valve replacement as an example, this introductory report paves the way to more definitive studies of these issues in the future. From 1961 to 2003, 4617 adult patients underwent aortic valve replacement at our service. These patients were provided with a prospective lifetime follow-up. As of 2005, these patients had accumulated 31,671 patient-years of follow-up (maximum 41 years) and had returned 22,396 yearly questionnaires. A statistical model was used to estimate the future life years of patients who are currently alive. In the absence of direct estimates of utility, quality-adjusted life years were estimated from New York Heart Association class. The cost-effectiveness ratio was calculated by the patient's age at surgery. The overall cost-effectiveness ratio was approximately 13,528 dollars per quality-adjusted life year gained. The cost-effectiveness ratio increased according to age at surgery, up to 19,826 dollars per quality-adjusted life year for octogenarians and 27,182 dollars per quality-adjusted life year for nonagenarians. Given the limited scope of this introductory study, aortic valve replacement is cost-effective for all age groups and is very cost-effective for all but the most elderly according to standard econometric rules of thumb.

Prevalence of pannus formation after aortic valve replacement: clinical aspects and surgical management.

PubMed

Sakamoto, Yoshimasa; Hashimoto, Kazuhiro; Okuyama, Hiroshi; Ishii, Shinichi; Shingo, Taguchi; Kagawa, Hiroshi

2006-01-01

Pannus formation after aortic valve replacement is not common, but obstruction due to chronic pannus is one of the most serious complications of valve replacement. The causes of pannus formation are still unknown and effective preventive methods have not been fully elucidated. We reviewed our clinical experience of all patients who underwent reoperation for prosthetic aortic valve obstruction due to pannus formation between 1973 and 2004. We compared the initial 18-year period of surgery, when the Björk-Shiley tilting-disk valve was used, and the subsequent 13-year period of surgery, when the St. Jude Medical valve was used. Seven of a total of 390 patients (1.8%) required reoperation for prosthetic aortic valve obstruction due to pannus formation. All seven patients were women; four patients underwent resection of the pannus and three patients needed replacement of the valve. The frequency of pannus formation in the early group was 2.4% (6/253), whereas it was 0.73% (1/137) in the late group (P < 0.05). Pannus was localized at the minor orifice of the Björk-Shiley valve in the early group and turbulent transvalvular blood flow was considered to be one of the important factors triggering its growth. We also consider that small bileaflet valves have the possibility of promoting pannus formation and that the implantation of a larger prosthesis can contribute to reducing the occurrence of pannus.

Management of mitral regurgitation in Marfan syndrome: Outcomes of valve repair versus replacement and comparison with myxomatous mitral valve disease.

PubMed

Helder, Meghana R K; Schaff, Hartzell V; Dearani, Joseph A; Li, Zhuo; Stulak, John M; Suri, Rakesh M; Connolly, Heidi M

2014-09-01

The study objective was to evaluate patients with Marfan syndrome and mitral valve regurgitation undergoing valve repair or replacement and to compare them with patients undergoing repair for myxomatous mitral valve disease. We reviewed the medical records of consecutive patients with Marfan syndrome treated surgically between March 17, 1960, and September 12, 2011, for mitral regurgitation and performed a subanalysis of those with repairs compared with case-matched patients with myxomatous mitral valve disease who had repairs (March 14, 1995, to July 5, 2013). Of 61 consecutive patients, 40 underwent mitral repair and 21 underwent mitral replacement (mean [standard deviation] age, 40 [18] vs 31 [19] years; P = .09). Concomitant aortic surgery was performed to a similar extent (repair, 45% [18/40] vs replacement, 43% [9/21]; P = .87). Ten-year survival was significantly better in patients with Marfan syndrome with mitral repair than in those with replacement (80% vs 41%; P = .01). Mitral reintervention did not differ between mitral repair and replacement (cumulative risk of reoperation, 27% vs 15%; P = .64). In the matched cohort, 10-year survival after repair was similar for patients with Marfan syndrome and myxomatous mitral disease (84% vs 78%; P = .63), as was cumulative risk of reoperation (17% vs 12%; P = .61). Patients with Marfan syndrome and mitral regurgitation have better survival with repair than with replacement. Survival and risk of reoperation for patients with Marfan syndrome were similar to those for patients with myxomatous mitral disease. These results support the use of mitral valve repair in patients with Marfan syndrome and moderate or more mitral regurgitation, including those having composite replacement of the aortic root. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Medium-term outcome of Toronto aortic valve replacement: single center experience.

PubMed

Li, Wei; Price, Susanna; O'Sullivan, Christine A; Kumar, Pankaj; Jin, Xu Y; Henein, Michael Y; Pepper, John R

2008-09-26

Long-term competence of any aortic prosthesis is critical to its clinical durability. Bioprosthetic valves, and in particular the stentless type have been proposed to offer superior haemodynamic profiles with consequent potential for superior left-ventricular mass regression. These benefits however are balanced by the potential longevity of the implanted valve. The aims of this study were to assess medium-term Toronto aortic valve function and its effect on left-ventricular function. Between 1992 and 1996 86 patients underwent Toronto aortic valve replacement for aortic valve disease and were followed up annually. Prospectively collected data was analyzed for all patients where detailed echocardiographic follow-up was available. Echocardiographic studies were analyzed at 2+/-0.6 and 6+/-1.4 years after valve replacement. Data collected included left-ventricular systolic and diastolic dimensions, fractional shortening and left-ventricular mass. In addition, data on aortic valve and root morphology, peak aortic velocities, time velocity integral, stroke volume and the mechanism of valve failure where relevant, were also collected. Complete echocardiographic data were available for eighty-four patients, age 69+/-9 years, 62 male. Additional coronary artery bypass grafting was performed in 38% of patients. Twelve (14%) valves had failed during follow-up, 7 (8%) requiring re-operation. Valve failure was associated with morphologically bicuspid native aortic valve (9/12), and progressive dilatation of the aortic sinuses, sino-tubular junction and ascending aorta (11/12). Left-ventricular mass index remained high (184+/-75 g/m(2)) and did not continue to regress between early and medium-term follow-up (175.8+/-77 g/m(2)). Although more than 90% of implanted Toronto aortic valves remained haemodynamically stable with low gradient at medium-term follow-up, young age and larger aortic dimensions in patients with valve failure suggest better outcome if used in the elderly

Neurocognitive functions after beating heart mitral valve replacement without cross-clamping the aorta.

PubMed

Cicekcioglu, Ferit; Ozen, Anil; Tuluce, Hicran; Tutun, Ufuk; Parlar, Ali Ihsan; Kervan, Umit; Karakas, Sirel; Katircioglu, Salih Fehmi

2008-01-01

Although neurologic outcome after cardiac surgery is well-established, neurocognitive functions after beating heart mitral valve replacement still needs to be elucidated. The aim of this study was to compare preoperative and postoperative neurocognitive functions in patients who underwent beating heart mitral valve replacement on cardiopulmonary bypass without cross-clamping the aorta. The prospective study included 25 consecutive patients who underwent mitral valve replacement. The operations were carried out on a beating heart method using normothermic cardiopulmonary bypass without cross-clamping the aorta. All patients were evaluated preoperatively (E1) and postoperatively (at sixth day [E2] and second month [E3]) for neurocognitive functions. Neurologic deficit was not observed in the postoperative period. Comparison of the neurocognitive test results, between the preoperative and postoperative assessment for both hemispheric cognitive functions, demonstrated that no deterioration occurred. In the three subsets of left hemispheric cognitive function test evaluation, total verbal learning, delayed recall, and recognition, significant improvements were detected at the postoperative second month (E3) compared to the preoperative results (p = 0.005, 0.01, and 0.047, respectively). Immediate recall and retention were significantly improved within the first postoperative week (E2) when compared to the preoperative results (p = 0.05 and 0.05, respectively). The technique of mitral valve replacement with normothermic cardiopulmonary bypass without cross-clamping of the aorta may be safely used for majority of patients requiring mitral valve replacement without causing deterioration in neurocognitive functions.

Successful replacement of the systemic tricuspid valve with a mechanical valve in a 3-month-old boy with congenitally corrected transposition of the great arteries having a dysplastic tricuspid valve.

PubMed

Asada, Dai; Ikeda, Kazuyuki; Yamagishi, Masaaki

2017-04-01

There are a few reports of successful replacement of the left-sided systemic tricuspid valve with a mechanical valve in small infants with congenitally corrected transposition of the great arteries having Ebstein's anomaly. Tricuspid valve replacement is the preferred option when pulmonary artery banding, performed as a prelude to performing the double-switch operation, is not feasible because of severe heart failure caused by tricuspid regurgitation.

Mitral valve replacement for mitral stenosis: A 15-year single center experience.

PubMed

Al Mosa, Alqasem F; Omair, Aamir; Arifi, Ahmed A; Najm, Hani K

2016-10-01

Mitral valve replacement with either a bioprosthetic or a mechanical valve is the treatment of choice for severe mitral stenosis. However, choosing a valve implant type is still a subject of debate. This study aimed to evaluate and compare the early and late outcomes of mitral valve replacement [mechanical (MMV) vs. bioprosthetic (BMV)] for severe mitral stenosis. A retrospective cohort study was performed on data involving mitral stenosis patients who have undergone mitral valve replacement with either BMV (n = 50) or MMV (n = 145) valves from 1999 to 2012. Data were collected from the patients' records and follow-up through telephone calls. Data were analyzed for early and late mortality, New York Heart Association (NYHA) functional classes, stroke, pre- and postoperative echocardiographic findings, early and late valve-related complications, and survival. Chi-square test, logistic regression, Kaplan-Meier curve, and dependent proportions tests were some of the tests employed in the analysis. A total of 195 patients were included in the study with a 30-day follow-up echocardiogram available for 190 patients (97.5%), while 103 (53%) were available for follow-up over the telephone. One patient died early postoperatively; twelve patients died late in the postoperative period, six in the bioprosthesis group and six in the mechanical group. The late mortality had a significant association with postoperative stroke (p < 0.001) and postoperative NYHA Classes III and IV (p = 0.002). Postoperative NYHA class was significantly associated with age (p = 0.003), pulmonary disease (p = 0.02), mitral valve implant type (p = 0.01), and postoperative stroke (p = 0.02); 14 patients had strokes in the mechanical (9) and in the bioprosthetic (5) groups. NYHA classes were significantly better after the replacement surgeries (p < 0.001). BMV were significantly associated with worse survival (p = 0.03), worse NYHA postoperatively (p = 0.01), and more reoperations

Unusual cause of central aortic prosthetic regurgitation during transcatheter replacement.

PubMed

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

2016-04-01

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

Long-term Outcomes of Mitral Valve Repair Versus Replacement for Degenerative Disease: A Systematic Review

PubMed Central

McNeely, Christian A; Vassileva, Christina M

2015-01-01

The short-term advantage of mitral valve repair versus replacement for degenerative disease has been extensively documented. These advantages include lower operative mortality, improved survival, better preservation of left-ventricular function, shorter post-operative hospital stay, lower total costs, and fewer valve-related complications, including thromboembolism, anticoagulation-related bleeding events and late prosthetic dysfunction. More recent written data are available indicating the long-term advantage of repair versus replacement. While at some institutions, the repair rate for degenerative disease may exceed 90%, the national average in 2007 was only 69%. Making direct comparisons between mitral valve repair and replacement using the available studies does present some challenges however, as there are often differences in baseline characteristics between patient groups as well as other dissimilarities between studies. The purpose of this review is to systematically summarize the long-term survival and reoperation data of mitral valve repair versus replacement for degenerative disease. A PubMed search was done and resulted in 12 studies that met our study criteria for comparing mitral valve repair versus replacement for degenerative disease. A systematic review was then conducted abstracting survival and reoperation data. PMID:25158683

Aortic valve replacement in elderly patients.

PubMed

Glock, Y; Pecoul, R; Cerene, A; Laguerre, J; Puel, P

1984-01-01

The results for 62 consecutive patients aged 70 or more given aortic valve replacement (A.V.R.) between 1970 and 1982 are reported. All the patients were in the New York Heart Association (N.Y.H.A.) functional class III (29%) or IV (71%); 54.8% had angina and 30.6% had experienced syncope. Forty patients had aortic stenosis (A.S.), 10 had aortic regurgitation and 12 had mixed aortic valve disease. The operative myocardial infarction rate was 6.4%. Tilting disk valves were used. Eighty percent of the patients were anticoagulated with Warfarin whilst twenty percent received only antiplatelet drugs. All the patients were followed up for a mean period of 26 months; late mortality was 22.6% with 4.8% cardiac deaths. The thromboembolic rate was 1.6% and the disinsertion rate was 3.2%. Cerebral stroke was fatal in 3 cases in anticoagulated patients but the mechanism of the accident was not known. At the termination of the study 93% of surviving patients were in N.Y.H.A. class I or II. No patient was in class IV. The probability of five year survival is 71% for the entire group.

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

PubMed

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

2016-01-01

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

Beating heart mitral valve replacement with a bovine pericardial bioprosthesis for treatment of mitral valve dysplasia in a Bull Terrier.

PubMed

Behr, Luc; Chetboul, Valérie; Sampedrano, Carolina Carlos; Vassiliki, Gouni; Pouchelon, Jean-Louis; Laborde, François; Borenstein, Nicolas

2007-04-01

To describe an open, beating heart surgical technique and use of a bovine pericardial prosthetic valve for mitral valve replacement (MVR) in the dog. Clinical case report. Male Bull Terrier (17-month-old, 26 kg) with mitral valve dysplasia and severe regurgitation. A bovine pericardial bioprosthesis was used to replace the mitral valve using an open beating heart surgical technique and cardiopulmonary bypass. Successful MVR was achieved using a beating heart technique. Mitral regurgitation resolved and cardiac performances improved (left ventricular end-diastolic diameter decreased from 57.6 to 48.7 mm, and left atrium/aorta ratio returned to almost normal, from 1.62 to 1.19). Cardiopulmonary by-pass time and total surgical duration were decreased compared with standard cardioplegic techniques. Surgical recovery was uneventful and on echocardiography 6 months later valve function was excellent. Considering the technique advantages (no cardiac arrest, ischemic reperfusion injury, and hypothermia, or the need for aortic dissection and cannulation for administration of cardioplegic solution), short-term mortality and morbidity may be reduced compared with standard cardioplegic techniques. Based on experience in this dog, beating heart mitral valvular replacement is a seemingly safe and viable option for the dog and bovine pericardial prosthesis may provide better long-term survival than mechanical prostheses.

Mitral regurgitation in patients with severe aortic stenosis: diagnosis and management.

PubMed

Sannino, Anna; Grayburn, Paul A

2018-01-01

Severe aortic stenosis (AS) and mitral regurgitation (MR) frequently coexist. Although some observational studies have reported that moderate or severe MR is associated with higher mortality, the optimal management of such patients is still unclear. Simultaneous replacement of both aortic and mitral valves is linked to significantly higher morbidity and mortality. Recent advances in minimally invasive surgical or transcatheter therapies for MR allow for staged procedures in which surgical or transcatheter aortic valve replacement (SAVR/TAVR) is done first and MR severity re-evaluated afterwards. Current evidence suggests MR severity improves in some patients after SAVR or TAVR, depending on several factors (MR aetiology, type of valve used for TAVR, presence/absence of atrial fibrillation, residual aortic regurgitation, etc). However, as of today, the absence of randomised clinical trials does not allow for evidence-based recommendations about whether or not MR should be addressed at the time of SAVR or TAVR. A careful patient evaluation and clinical judgement are recommended to distinguish patients who might benefit from a double valve intervention from those in which MR should be left alone. The aim of this review is to report and critique the available data on this subject in order to help guide the clinical decision making in this challenging subset of patients. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

COMBINED REPLACEMENT OF THE AORTIC VALVE AND ASCENDING AORTA IN JEHOVAH'S WITNESSES: REPORT OF TWO CASES

PubMed Central

Beddermann, Christoph; Norman, John C.; Cooley, Denton A.

1979-01-01

Two Jehovah's Witnesses with large ascending thoracic aortic aneurysms and aortic insufficiency secondary to annuloaortic ectasia underwent successful combined replacement of the aortic valve and the ascending aorta. One patient received a composite graft containing an aortic valve prosthesis, which necessitated supravalvular coronary ostia reimplantation; the other patient underwent separate aortic valve and left supracoronary ascending aneurysm replacement, with reimplantation of the right coronary ostium into the graft. No blood or blood derivatives were administered. Both patients had uneventful recoveries and continue to do well. To our knowledge, they represent the first reported cases of successful combined replacement of the aortic valve and ascending aorta in Jehovah's Witnesses. Images PMID:15216324

Pre-procedural assessment of aortic annulus dimensions for transcatheter aortic valve replacement: comparison of a non-contrast 3D MRA protocol with contrast-enhanced cardiac dual-source CT angiography.

PubMed

Ruile, Philipp; Blanke, Philipp; Krauss, Tobias; Dorfs, Stephan; Jung, Bernd; Jander, Nikolaus; Leipsic, Jonathon; Langer, Mathias; Neumann, Franz-Josef; Pache, Gregor

2016-04-01

To evaluate the feasibility of a non-contrast three-dimensional (3D)-FLASH magnetic resonance angiography (MRA) protocol for pre-procedural aortic annulus assessment for transcatheter aortic valve replacement (TAVR) in comparison with cardiac dual-source computed tomography angiography (CTA). In this prospective study, 69 of 104 consecutive patients (mean age 81.8 ± 5.4 years, 37.7% arrhythmic) with severe aortic stenosis who had undergone pre-TAVR cardiac CTA received a respiratory and ECG-triggered, non-contrast 3D-FLASH MRA at 3 T. Annular area measurements were obtained at mid-diastole for both modalities whereas maximum systolic area was assessed by CTA only. Systolic MRA dimensions were modelled, by adding the relative difference of systolic and diastolic CTA area dimensions as a corrective factor. Hypothetical prosthesis sizing was performed based on systolic CTA, diastolic, and modelled systolic MRA area measurements. MR image quality and degree of annular calcifications were evaluated using 4-point-grading scales. The mean acquisition time was 14 ± 4.2 min. The mean image quality was 3.1 ± 0.9 with only two examinations rated non-diagnostic. The mean degree of calcifications was equal. As assessed by Bland-Altman analysis, there was no relevant systematic difference between area measurements for modelled systolic MRA and systolic CTA [the mean difference -3.1 mm(2) (limits of agreement -44.4 mm(2); 38.2 mm(2))]. Agreement for hypothetical prosthesis sizing was found in 63 of 67 (94%) patients for systolic CTA and modelled systolic MRA. The employed non-contrast 3D-FLASH MRA protocol allows for reliable assessment of aortic annulus dimensions and calcifications even in the presence of arrhythmias in an all-comers pre-TAVR population. Implementation of this technique appears legitimate in patients at an increased risk for contrast-induced nephropathy. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For

Coronary ostia obstruction after replacement of aortic valve prostesis

PubMed Central

2011-01-01

Aortic valve replacement (AVR) is the gold standard for the treatment of severe symptomatic aortic stenosis. Complications directly related to surgical procedure are relatively infrequent. Coronary ostial stenosis is, generally, referred as late complication. Anecdotal reports concern coronary ostial stenosis as acute complication. A unique fatal case of intraoperative, bilateral coronary ostial obstruction by prosthetic valve leading to an extensive myocardial infarction is reported. Surgeons must have a high level of vigilance regarding the occurrence of acute myocardial ischemia and sudden death soon after AVR. PMID:21810231

One-year outcome following biological or mechanical valve replacement for infective endocarditis.

PubMed

Delahaye, F; Chu, V H; Altclas, J; Barsic, B; Delahaye, A; Freiberger, T; Gordon, D L; Hannan, M M; Hoen, B; Kanj, S S; Lejko-Zupanc, T; Mestres, C A; Pachirat, O; Pappas, P; Lamas, C; Selton-Suty, C; Tan, R; Tattevin, P; Wang, A

2015-01-15

Nearly half of patients require cardiac surgery during the acute phase of infective endocarditis (IE). We describe the characteristics of patients according to the type of valve replacement (mechanical or biological), and examine whether the type of prosthesis was associated with in-hospital and 1-year mortality. Among 5591 patients included in the International Collaboration on Endocarditis Prospective Cohort Study, 1467 patients with definite IE were operated on during the active phase and had a biological (37%) or mechanical (63%) valve replacement. Patients who received bioprostheses were older (62 vs 54years), more often had a history of cancer (9% vs 6%), and had moderate or severe renal disease (9% vs 4%); proportion of health care-associated IE was higher (26% vs 17%); intracardiac abscesses were more frequent (30% vs 23%). In-hospital and 1-year death rates were higher in the bioprosthesis group, 20.5% vs 14.0% (p=0.0009) and 25.3% vs 16.6% (p<.0001), respectively. In multivariable analysis, mechanical prostheses were less commonly implanted in older patients (odds ratio: 0.64 for every 10years), and in patients with a history of cancer (0.72), but were more commonly implanted in mitral position (1.60). Bioprosthesis was independently associated with 1-year mortality (hazard ratio: 1.298). Patients with IE who receive a biological valve replacement have significant differences in clinical characteristics compared to patients who receive a mechanical prosthesis. Biological valve replacement is independently associated with a higher in-hospital and 1-year mortality, a result which is possibly related to patient characteristics rather than valve dysfunction. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Consequence of patient substitution of nattokinase for warfarin after aortic valve replacement with a mechanical prosthesis.

PubMed

Elahi, Maqsood M; Choi, Charles H; Konda, Subbareddy; Shake, Jay G

2015-01-01

This report describes a patient's self-substitution of nattokinase for the vitamin K antagonist warfarin after aortic valve replacement with a mechanical prosthesis. Nattokinase is an enzyme derived from a popular fermented soybean preparation in Japan (natto), which has fibrinolytic properties and is gaining popularity in nontraditional health journals and nonmedical health websites as an over-the-counter thrombolytic. After nearly a year of use of nattokinase without warfarin, the patient developed thrombus on the mechanical valve and underwent successful repeat valve replacement. We believe this is the first documented case of nattokinase being used as a substitute for warfarin after valve replacement, and we strongly discourage its use for this purpose.

Consequence of patient substitution of nattokinase for warfarin after aortic valve replacement with a mechanical prosthesis

PubMed Central

Elahi, Maqsood M.; Choi, Charles H.; Konda, Subbareddy

2015-01-01

This report describes a patient's self-substitution of nattokinase for the vitamin K antagonist warfarin after aortic valve replacement with a mechanical prosthesis. Nattokinase is an enzyme derived from a popular fermented soybean preparation in Japan (natto), which has fibrinolytic properties and is gaining popularity in nontraditional health journals and nonmedical health websites as an over-the-counter thrombolytic. After nearly a year of use of nattokinase without warfarin, the patient developed thrombus on the mechanical valve and underwent successful repeat valve replacement. We believe this is the first documented case of nattokinase being used as a substitute for warfarin after valve replacement, and we strongly discourage its use for this purpose. PMID:25552810

Aortic valve replacement and tricuspid valve annuloplasty via a left thoracotomy in an adult with left pulmonary agenesis.

PubMed

Furutachi, Akira; Furukawa, Kojiro; Shimauchi, Kouta; Yunoki, Junji; Itoh, Manabu; Takamatsu, Masanori; Nogami, Eijiro; Mukae, Yosuke; Nishida, Takahiro

2018-06-06

We report a case of a 66-year-old man who was diagnosed with severe aortic regurgitation, moderate tricuspid regurgitation and chronic atrial fibrillation. Preoperative computed tomography showed left lung agenesis. We performed aortic valve replacement, tricuspid valve annuloplasty and right pulmonary vein isolation via a left thoracotomy. This approach provided an adequate field of view.

Root replacement using stentless valves in the small aortic root: a propensity score analysis.

PubMed

Kunihara, Takashi; Schmidt, Kathrin; Glombitza, Petra; Dzindzibadze, Vachtang; Lausberg, Henning; Schäfers, Hans-Joachim

2006-10-01

Root replacement using a stentless bioprosthesis may be the optimal approach to avoid patient-prosthesis mismatch in patients with a small aortic root. Primary root replacement, however, is considered to be associated with increased surgical risk. We compared early outcome of full root replacement with a stentless bioprosthesis with that of aortic valve replacement with a stented bioprosthesis using propensity score-matching analysis. Of 231 patients undergoing elective, first-time aortic valve replacement with a small root (< or = 22 mm), 120 patients were selected using propensity score-matching analysis. They underwent either root replacement using a 23-mm stentless bioprosthesis (stentless group, n = 60) or supra-annular aortic valve replacement using a 21-mm stented bioprosthesis (stented group, n = 60). Preoperative characteristics and frequency of concomitant operations were identical. Duration of operation (196 +/- 54 versus 174 +/- 49 minutes), cardiopulmonary bypass (112 +/- 36 versus 91 +/- 33 minutes), and aortic cross-clamping (76 +/- 21 versus 61 +/- 21 minutes) were significantly longer in the stentless group. However, the need for perioperative transfusion and the incidence of postoperative reexploration for bleeding (3% versus 8%) was lower, and ventilation time was shorter. Mean duration of intensive care and hospital stay were also significantly shorter (2.3 +/- 1.7 versus 4.0 +/- 3.9 days, 8.9 +/- 3.1 versus 12.4 +/- 5.7 days). In-hospital mortality was identical (5% each). No independent predictor for in-hospital mortality was identified. Full root replacement using a stentless bioprosthesis does not increase postoperative morbidity or mortality of aortic valve replacement and may be advantageous in patients with a small aortic root.

Intracardiac echocardiography to diagnose pannus formation after aortic valve replacement.

PubMed

Yamamoto, Yoshiya; Ohara, Takahiro; Funada, Akira; Takahama, Hiroyuki; Amaki, Makoto; Hasegawa, Takuya; Sugano, Yasuo; Kanzaki, Hideaki; Anzai, Toshihisa

2016-03-01

A 66-year-old female, under regular follow-up for 20 years after aortic valve replacement (19-mm Carbomedics), presented dyspnea on effort and hypotension during hemodialysis. A transthoracic echocardiogram showed elevation of transvalvular velocity up to 4 m/s, but the structure around the aortic prosthesis was difficult to observe due to artifacts. Fluoroscopy revealed normal motion of the leaflets of the mechanical valve. Intracardiac echocardiography (ICE) revealed a pannus-like structure in the left ventricular outflow tract. Transesophageal echocardiogram also revealed this structure. ICE can visualize structural abnormalities around a prosthetic valve after cardiac surgery even in patients in whom conventional imaging modalities failed.

Minimally Invasive Aortic Valve Replacement Following Root Enlargement on too Narrow Annulus to Perform Transcatheter Aortic Valve Implantation.

PubMed

Sakamoto, Kosuke; Totsugawa, Toshinori; Hiraoka, Arudo; Tamura, Kentaro; Yoshitaka, Hidenori; Sakaguchi, Taichi

2018-05-30

An 88-year-old woman was diagnosed with aortic stenosis and an aortic annulus that was too narrow to perform transcatheter aortic valve implantation. Surgery was performed through a 7-cm right mini-thoracotomy at the fourth intercostal space. A 19-mm aortic valve bioprosthesis was implanted after root enlargement. The fourth intercostal space was a suitable site for aortic root enlargement because of the shorter skin-to-root distance and the detailed exposure of the aortic valve after cutting the aortic wall. This study concluded that minimally-invasive aortic valve replacement following root enlargement can be an option for the treatment of elderly patients with aortic stenosis accompanied by an annulus that is too small to perform transcatheter aortic valve implantation.

Transcatheter Aortic Valve-in-Valve Procedure in Patients with Bioprosthetic Structural Valve Deterioration

PubMed Central

Reul, Ross M.; Ramchandani, Mahesh K.; Reardon, Michael J.

2017-01-01

Surgical aortic valve replacement is the gold standard procedure to treat patients with severe, symptomatic aortic valve stenosis or insufficiency. Bioprosthetic valves are used for surgical aortic valve replacement with a much greater prevalence than mechanical valves. However, bioprosthetic valves may fail over time because of structural valve deterioration; this often requires intervention due to severe bioprosthetic valve stenosis or regurgitation or a combination of both. In select patients, transcatheter aortic valve replacement is an alternative to surgical aortic valve replacement. Transcatheter valve-in-valve (ViV) replacement is performed by implanting a transcatheter heart valve within a failing bioprosthetic valve. The transcatheter ViV operation is a less invasive procedure compared with reoperative surgical aortic valve replacement, but it has been associated with specific complications and requires extensive preoperative work-up and planning by the heart team. Data from experimental studies and analyses of results from clinical procedures have led to strategies to improve outcomes of these procedures. The type, size, and implant position of the transcatheter valve can be optimized for individual patients with knowledge of detailed dimensions of the surgical valve and radiographic and echocardiographic measurements of the patient's anatomy. Understanding the complexities of the ViV procedure can lead surgeons to make choices during the original surgical valve implantation that can make a future ViV operation more technically feasible years before it is required. PMID:29743998

Criteria for determining the need for surgical treatment of tricuspid regurgitation during mitral valve replacement

PubMed Central

2012-01-01

Background Tricuspid regurgitation (TR) is common in patients with mitral valve disease; however, there are no straightforward, rapidly determinably criteria available for deciding whether TR repair should be performed during mitral valve replacement. The aim of our retrospective study was to identify a simple and fast criterion for determining whether TR repair should be performed in patients undergoing mitral valve replacement. Methods We reviewed the records of patients who underwent mitral valve replacement with or without (control) TR repair (DeVega or Kay procedure) from January 2005 to December 2008. Preoperative and 2-year postoperative echocardiographic measurements included right ventricular and atrial diameter, interventricular septum size, TR severity, ejection fraction, and pulmonary artery pressure. Results A total of 89 patients were included (control, n = 50; DeVega, n = 27; Kay, n = 12). Demographic and clinical characteristics were similar between groups. Cardiac variables were similar between the DeVega and Kay groups. Right atrium and ventricular diameter and ejection fraction were significantly decreased postoperatively both in the control and operation (DeVega + Kay) group (P < 0.05). Pulmonary artery pressure was significantly decreased postoperatively in-operation groups (P < 0.05). Our findings indicate that surgical intervention for TR should be considered during mitral valve replacement if any of the following preoperative criteria are met: right atrial transverse diameter > 57 mm; right ventricular end-diastolic diameter > 55 mm; pulmonary artery pressure > 58 mmHg. Conclusions Our findings suggest echocardiography may be used as a rapid and simple means of determining which patients require TR repair during mitral valve replacement. PMID:22443513

Long-term outcome in dogs undergoing mitral valve repair with suture annuloplasty and chordae tendinae replacement.

PubMed

Mizuno, T; Mizukoshi, T; Uechi, M

2013-02-01

Mitral valve repair under cardiopulmonary bypass was performed in three dogs with clinical signs associated with mitral regurgitation that were not controlled by medication. Mitral valve repair comprised circumferential annuloplasty and chordal replacement with expanded polytetrafluoroethylene. One dog died 2 years after surgery because of severe mitral regurgitation resulting from partial circumferential suture detachment. The others survived for over 5 years, but mild mitral valve stenosis persisted in one. The replaced chordae did not rupture in any dog. Mitral valve repair appears to be an effective treatment for mitral regurgitation in dogs. Chordal replacement with expanded polytetrafluoroethylene is a feasible technique, demonstrating long-term durability in dogs. However, mitral annuloplasty techniques need improvement. © 2012 British Small Animal Veterinary Association.

Aortic valve replacement for stenosis with or without coronary artery bypass grafting after 2 previous isolated coronary artery bypass grafting operations

PubMed Central

Lee Henry, Christopher; Ko, Jong Mi; Henry, Albert Carl; Matter, Gregory John

2011-01-01

Aortic valve replacement following an earlier coronary artery bypass grafting (CABG) procedure is fairly common. When this situation occurs, the type of valve dysfunction is usually stenosis (with or without regurgitation), and whether it was missed at the time of the earlier CABG or developed subsequently is usually unclear. We attempted to determine the survival in patients who had had aortic valve replacement after 2 previous CABG procedures. We describe 12 patients who had aortic valve replacement for aortic stenosis; rather than one previous CABG operation, all had had 2 previous CABG procedures. Only one patient died in the early postoperative period after aortic valve replacement, and the remaining 11 were improved substantially: all have lived at least 11 months, and one is still alive at over 101 months after aortic valve replacement. Aortic valve replacement remains beneficial for most patients even after 2 previous CABG procedures. PMID:21307968

Mitral valve disease in patients with Marfan syndrome undergoing aortic root replacement.

PubMed

Kunkala, Meghana R; Schaff, Hartzell V; Li, Zhuo; Volguina, Irina; Dietz, Harry C; LeMaire, Scott A; Coselli, Joseph S; Connolly, Heidi

2013-09-10

Cardiac manifestations of Marfan syndrome include aortic root dilation and mitral valve prolapse (MVP). Only scant data exist describing MVP in patients with Marfan syndrome undergoing aortic root replacement. We retrospectively analyzed data from 166 MFS patients with MVP who were enrolled in a prospective multicenter registry of patients who underwent aortic root aneurysm repair. Of these 166 patients, 9% had mitral regurgitation (MR) grade >2, and 10% had MR grade 2. The severity of MVP and MR was evaluated by echocardiography preoperatively and ≤ 3 years postoperatively. Forty-one patients (25%) underwent composite graft aortic valve replacement, and 125 patients (75%) underwent aortic valve-sparing procedures; both groups had similar prevalences of MR grade >2 (P=0.7). Thirty-three patients (20%) underwent concomitant mitral valve (MV) intervention (repair, n=29; replacement, n=4), including all 15 patients with MR grade >2. Only 1 patient required MV reintervention during follow-up (mean clinical follow-up, 31 ± 10 months). Echocardiography performed 21 ± 13 months postoperatively revealed MR >2 in only 3 patients (2%). One early death and 2 late deaths occurred. Although the majority of patients with Marfan syndrome who undergo elective aortic root replacement have MVP, only 20% have concomitant MV procedures. These concomitant procedures do not seem to increase operative risk. In patients with MR grade ≤ 2 who do not undergo a concomitant MV procedure, the short-term incidence of progressive MR is low; however, more follow-up is needed to determine whether patients with MVP and MR grade ≤ 2 would benefit from prophylactic MV intervention.

Aortic valve replacement during acute rheumatic fever.

PubMed

Khan, A; Chi, S; Gonzalez-Lavin, L

1978-07-01

Emergency aortic valve replacement was performed during an attack of acute rheumatic fever in a 12-year-old black boy. He had an uneventful recovery and has remained asymptomatic 27 months after operation. In the light of this experience and that of others, one might conclude that the decision to operate on these patients should be based on the severity of the haemodynamic derangement rather than on the state of activity in the rheumatic process.

Aortic valve replacement in octogenarians.

PubMed

Bose, Amal K; Aitchison, James D; Dark, John H

2007-07-13

As our population ages and life expectancy increases the number of people aged over 80 and more referred for cardiac surgery is growing. This study sought to identify the outcome of aortic valve replacement (AVR) in octogenarians. 68 patients aged 80 years or more underwent AVR at the Freeman Hospital, between April 2001 and April 2004. A retrospective review of the notes and outcomes from the patients' GP and the NHS strategic tracking service was performed. 54% (37) underwent isolated AVR whilst 46% (31) underwent combined AVR and CABG. Follow up was 100% complete. The mean age was 83.1 +/- s.d. 2.9 years, a mean gradient of 83 +/- s.d. 31 mmHg and mean AVA of 0.56 cm2. The mean additive EuroSCORE was 8.6 +/- s.d. 1.2, the logistic EuroSCORE mean 12.0 +/- s.d. 5.9. In hospital 30 day mortality was 13 %. Survival was 80% at 1 year and 78% at 2 years. Median follow up was for 712 days. Stepwise logistic regression identified chronic obstructive airways disease as an independent predictor of mortality (p < 0.05). Survival was not adversely affected by the addition of coronary artery bypass grafts to aortic valve replacement, the presence of peripheral vascular disease, hypertension or diabetes. In this study duration of cross clamp or bypass time were not found to reach significance as independent predictors of mortality. Our study demonstrates that the operative mortality for AVR in the over eighties is good, whilst the mid to long term outcome is excellent There is a very low attrition rate with those undergoing the procedure living as long than their age matched population. This study confirms AVR is a safe, acceptable treatment for octogenarians with excellent mid term outcomes.

Society of Thoracic Surgeons Risk Score predicts hospital charges and resource use after aortic valve replacement.

PubMed

Arnaoutakis, George J; George, Timothy J; Alejo, Diane E; Merlo, Christian A; Baumgartner, William A; Cameron, Duke E; Shah, Ashish S

2011-09-01

The impact of Society of Thoracic Surgeons predicted mortality risk score on resource use has not been previously studied. We hypothesize that increasing Society of Thoracic Surgeons risk scores in patients undergoing aortic valve replacement are associated with greater hospital charges. Clinical and financial data for patients undergoing aortic valve replacement at The Johns Hopkins Hospital over a 10-year period (January 2000 to December 2009) were reviewed. The current Society of Thoracic Surgeons formula (v2.61) for in-hospital mortality was used for all patients. After stratification into risk quartiles, index admission hospital charges were compared across risk strata with rank-sum and Kruskal-Wallis tests. Linear regression and Spearman's coefficient assessed correlation and goodness of fit. Multivariable analysis assessed relative contributions of individual variables on overall charges. A total of 553 patients underwent aortic valve replacement during the study period. Average predicted mortality was 2.9% (±3.4) and actual mortality was 3.4% for aortic valve replacement. Median charges were greater in the upper quartile of patients undergoing aortic valve replacement (quartiles 1-3, $39,949 [interquartile range, 32,708-51,323] vs quartile 4, $62,301 [interquartile range, 45,952-97,103], P < .01]. On univariate linear regression, there was a positive correlation between Society of Thoracic Surgeons risk score and log-transformed charges (coefficient, 0.06; 95% confidence interval, 0.05-0.07; P < .01). Spearman's correlation R-value was 0.51. This positive correlation persisted in risk-adjusted multivariable linear regression. Each 1% increase in Society of Thoracic Surgeons risk score was associated with an added $3000 in hospital charges. This is the first study to show that increasing Society of Thoracic Surgeons risk score predicts greater charges after aortic valve replacement. As competing therapies, such as percutaneous valve replacement, emerge to

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

PubMed

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

2015-08-01

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

Outcome of aortic valve replacement for active infective endocarditis in patients on chronic hemodialysis.

PubMed

Dohmen, Pascal M; Binner, Christian; Mende, Meinhart; Bakhtiary, Farhad; Etz, Christian; Pfannmüller, Bettina; Davierwala, Piroze; Borger, Michael A; Misfeld, Martin; Mohr, Friedrich W

2015-02-01

The high risk of morbidity and mortality for patients on hemodialysis who are undergoing cardiac surgery is increased for those with active infective endocarditis (AIE). This retrospective observational single-center study evaluated the impact of chronic hemodialysis on the outcome of aortic valve replacement in patients with aortic AIE. Data were retrospectively collected for consecutive patients undergoing aortic valve surgery for AIE diagnosed according to modified Duke criteria between October 1994 and January 2011. Characteristics and outcomes of patients receiving preoperative chronic hemodialysis were analyzed. Aortic valve AIE was present in 992 patients. Forty-five (4.5%) of the aortic valve AIE patients were receiving long-term hemodialysis preoperatively, 19 of whom (42.2%) had diabetes mellitus. Mean logistic EuroSCORE was 64.2% ± 32.2%. Twenty-four preoperative septic emboli were found in 15 patients. Results of microbiologic cultures were positive in 36 patients, with the major causative organisms identified as Staphylococcus aureus (n = 17) and Enterococcus faecalis (n = 10). Isolated aortic valve replacement was performed in 19 patients (42.2%), and 26 patients (57.8%) underwent concomitant procedures. The mean follow-up was 5.3 ± 5.2 years (range, 0.1 to 17.1 years). Postoperative complications occurred in 30 patients (66.7%). Nineteen patients (42.2%) died within 30 days of surgery, which in 8 patients was attributable to a cardiac cause. In patients receiving chronic hemodialysis who undergo aortic valve replacement for acute AIE, postoperative mortality is high, especially in patients undergoing aortic root replacement or culture-negative AIE. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

The impact of the metabolic syndrome on the outcome after aortic valve replacement.

PubMed

Tadic, Marijana; Vukadinovic, Davor; Cvijanovic, Dane; Celic, Vera; Kocica, Mladen; Putnik, Svetozar; Ivanovic, Branislava

2014-10-01

The aim of this study was to examine the influence of the metabolic syndrome on the left ventricular geometry as well as on the early and mid-time outcome in patients with aortic stenosis who underwent aortic valve replacement. The study included 182 patients who underwent aortic valve replacement due to aortic stenosis. The metabolic syndrome was defined by the presence of at least three AHA-NHLB (American Heart Association/National Heart, Lung and Blood Institute) criteria. All the patients were followed for at least 2 years after the surgery. The metabolic syndrome did not influence the severity of aortic stenosis (mean gradient and aortic valve area). However, the metabolic syndrome was associated with the reduced prevalence of the normal left ventricular geometry and the increased risk of concentric left ventricular hypertrophy in patients with aortic stenosis. Among the metabolic syndrome criteria, only increased blood pressure was simultaneously associated with the short-term and mid-term outcome, independently of other risk factors. Increased fasting glucose level was an independent predictor of the only 30-day outcome after the valve replacement. The metabolic syndrome and left ventricular hypertrophy were, independently of hypertension and diabetes, associated with the 30-day outcome, as well as incidence of major cerebrovascular and cardiovascular events in the 2-year postoperative period. The metabolic syndrome does not change severity of the aortic stenosis, but significantly impacts the left ventricular remodeling in these patients. The metabolic syndrome and left ventricular hypertrophy, irrespective of hypertension and diabetes, are predictors of the short-term and mid-term outcome of patients with aortic stenosis who underwent aortic valve replacement.

Mitral-valve repair versus replacement for severe ischemic mitral regurgitation.

PubMed

Acker, Michael A; Parides, Michael K; Perrault, Louis P; Moskowitz, Alan J; Gelijns, Annetine C; Voisine, Pierre; Smith, Peter K; Hung, Judy W; Blackstone, Eugene H; Puskas, John D; Argenziano, Michael; Gammie, James S; Mack, Michael; Ascheim, Deborah D; Bagiella, Emilia; Moquete, Ellen G; Ferguson, T Bruce; Horvath, Keith A; Geller, Nancy L; Miller, Marissa A; Woo, Y Joseph; D'Alessandro, David A; Ailawadi, Gorav; Dagenais, Francois; Gardner, Timothy J; O'Gara, Patrick T; Michler, Robert E; Kron, Irving L

2014-01-02

Ischemic mitral regurgitation is associated with a substantial risk of death. Practice guidelines recommend surgery for patients with a severe form of this condition but acknowledge that the supporting evidence for repair or replacement is limited. We randomly assigned 251 patients with severe ischemic mitral regurgitation to undergo either mitral-valve repair or chordal-sparing replacement in order to evaluate efficacy and safety. The primary end point was the left ventricular end-systolic volume index (LVESVI) at 12 months, as assessed with the use of a Wilcoxon rank-sum test in which deaths were categorized below the lowest LVESVI rank. At 12 months, the mean LVESVI among surviving patients was 54.6±25.0 ml per square meter of body-surface area in the repair group and 60.7±31.5 ml per square meter in the replacement group (mean change from baseline, -6.6 and -6.8 ml per square meter, respectively). The rate of death was 14.3% in the repair group and 17.6% in the replacement group (hazard ratio with repair, 0.79; 95% confidence interval, 0.42 to 1.47; P=0.45 by the log-rank test). There was no significant between-group difference in LVESVI after adjustment for death (z score, 1.33; P=0.18). The rate of moderate or severe recurrence of mitral regurgitation at 12 months was higher in the repair group than in the replacement group (32.6% vs. 2.3%, P<0.001). There were no significant between-group differences in the rate of a composite of major adverse cardiac or cerebrovascular events, in functional status, or in quality of life at 12 months. We observed no significant difference in left ventricular reverse remodeling or survival at 12 months between patients who underwent mitral-valve repair and those who underwent mitral-valve replacement. Replacement provided a more durable correction of mitral regurgitation, but there was no significant between-group difference in clinical outcomes. (Funded by the National Institutes of Health and the Canadian Institutes of

Aortic valve replacement during acute rheumatic fever.

PubMed Central

Khan, A; Chi, S; Gonzalez-Lavin, L

1978-01-01

Emergency aortic valve replacement was performed during an attack of acute rheumatic fever in a 12-year-old black boy. He had an uneventful recovery and has remained asymptomatic 27 months after operation. In the light of this experience and that of others, one might conclude that the decision to operate on these patients should be based on the severity of the haemodynamic derangement rather than on the state of activity in the rheumatic process. Images PMID:687481

[Periodontal microbiota and microorganisms isolated from heart valves in patients undergoing valve replacement surgery in a clinic in Cali, Colombia].

PubMed

Moreno, Sandra; Parra, Beatriz; Botero, Javier E; Moreno, Freddy; Vásquez, Daniel; Fernández, Hugo; Alba, Sandra; Gallego, Sara; Castillo, Gilberto; Contreras, Adolfo

2017-12-01

Periodontitis is an infectious disease that affects the support tissue of the teeth and it is associated with different systemic diseases, including cardiovascular disease. Microbiological studies facilitate the detection of microorganisms from subgingival and cardiovascular samples. To describe the cultivable periodontal microbiota and the presence of microorganisms in heart valves from patients undergoing valve replacement surgery in a clinic in Cali. We analyzed 30 subgingival and valvular tissue samples by means of two-phase culture medium, supplemented blood agar and trypticase soy agar with antibiotics. Conventional PCR was performed on samples of valve tissue. The periodontal pathogens isolated from periodontal pockets were: Fusobacterium nucleatum (50%), Prevotella intermedia/ nigrescens (40%), Campylobacter rectus (40%), Eikenella corrodens (36.7%), Gram negative enteric bacilli (36.7%), Porphyromonas gingivalis (33.3%), and Eubacterium spp. (33.3%). The pathogens isolated from the aortic valve were Propionibacterium acnes (12%), Gram negative enteric bacilli (8%), Bacteroides merdae (4%), and Clostridium bifermentans (4%), and from the mitral valve we isolated P. acnes and Clostridium beijerinckii. Conventional PCR did not return positive results for oral pathogens and bacterial DNA was detected only in two samples. Periodontal microbiota of patients undergoing surgery for heart valve replacement consisted of species of Gram-negative bacteria that have been associated with infections in extraoral tissues. However, there is no evidence of the presence of periodontal pathogens in valve tissue, because even though there were valve and subgingival samples positive for Gram-negative enteric bacilli, it is not possible to maintain they corresponded to the same phylogenetic origin.

Comparison of acute elastic recoil between the SAPIEN-XT and SAPIEN valves in transfemoral-transcatheter aortic valve replacement.

PubMed

Garg, Aatish; Parashar, Akhil; Agarwal, Shikhar; Aksoy, Olcay; Hammadah, Muhammad; Poddar, Kanhaiya Lal; Puri, Rishi; Svensson, Lars G; Krishnaswamy, Amar; Tuzcu, E Murat; Kapadia, Samir R

2015-02-15

The SAPIEN-XT is a newer generation balloon-expandable valve created of cobalt chromium frame, as opposed to the stainless steel frame used in the older generation SAPIEN valve. We sought to determine if there was difference in acute recoil between the two valves. All patients who underwent transfemoral-transcatheter aortic valve replacement using the SAPIEN-XT valve at the Cleveland Clinic were included. Recoil was measured using biplane cine-angiographic image analysis of valve deployment. Acute recoil was defined as [(valve diameter at maximal balloon inflation) - (valve diameter after deflation)]/valve diameter at maximal balloon inflation (reported as percentage). Patients undergoing SAPIEN valve implantation were used as the comparison group. Among the 23 mm valves, the mean (standard deviation-SD) acute recoil was 2.77% (1.14) for the SAPIEN valve as compared to 3.75% (1.52) for the SAPIEN XT valve (P = 0.04). Among the 26 mm valves, the mean (SD) acute recoil was 2.85% (1.4) for the SAPIEN valve as compared to 4.32% (1.63) for the SAPIEN XT valve (P = 0.01). Multivariable linear regression analysis demonstrated significantly greater adjusted recoil in the SAPIEN XT valves as compared to the SAPIEN valves by 1.43% [(95% CI: 0.69-2.17), P < 0.001]. However, the residual peak gradient was less for SAPIEN XT compared to SAPIEN valves [18.86 mm Hg versus 23.53 mm Hg (P = 0.01)]. Additionally, no difference in paravalvular leak was noted between the two valve types (P = 0.78). The SAPIEN XT valves had significantly greater acute recoil after deployment compared to the SAPIEN valves. Implications of this difference in acute recoil on valve performance need to be investigated in future studies. © 2014 Wiley Periodicals, Inc.

Repair or Replacement for Isolated Tricuspid Valve Pathology? Insights from a Surgical Analysis on Long-Term Survival

PubMed Central

Farag, Mina; Arif, Rawa; Sabashnikov, Anton; Zeriouh, Mohamed; Popov, Aron-Frederik; Ruhparwar, Arjang; Schmack, Bastian; Dohmen, Pascal M.; Szabó, Gábor; Karck, Matthias; Weymann, Alexander

2017-01-01

Background Long-term follow-up data concerning isolated tricuspid valve pathology after replacement or reconstruction is limited. Current American Heart Association guidelines equally recommend repair and replacement when surgical intervention is indicated. Our aim was to investigate and compare operative mortality and long-term survival in patients undergoing isolated tricuspid valve repair surgery versus replacement. Material/Methods Between 1995 and 2011, 109 consecutive patients underwent surgical correction of tricuspid valve pathology at our institution for varying structural pathologies. A total of 41 (37.6%) patients underwent tricuspid annuloplasty/repair (TAP) with or without ring implantation, while 68 (62.3%) patients received tricuspid valve replacement (TVR) of whom 36 (53%) were mechanical and 32 (47%) were biological prostheses. Results Early survival at 30 days after surgery was 97.6% in the TAP group and 91.1% in the TVR group. After 6 months, 89.1% in the TAP group and 87.8% in the TVR group were alive. In terms of long-term survival, there was no further mortality observed after one year post surgery in both groups (Log Rank p=0.919, Breslow p=0.834, Tarone-Ware p=0.880) in the Kaplan-Meier Survival analysis. The 1-, 5-, and 8-year survival rates were 85.8% for TAP and 87.8% for TVR group. Conclusions Surgical repair of the tricuspid valve does not show survival benefit when compared to replacement. Hence valve replacement should be considered generously in patients with reasonable suspicion that regurgitation after repair will reoccur. PMID:28236633

Reoperations after tricuspid valve repair: re-repair versus replacement

PubMed Central

Hwang, Ho Young; Kim, Kyung-Hwan; Kim, Ki-Bong

2016-01-01

Background Data demonstrating results of reoperation after initial tricuspid valve repair are scarce. We evaluated outcomes of tricuspid reoperations after tricuspid valve repair and compared the results of tricuspid re-repair with those of tricuspid valve replacement (TVR). Methods From 1994 to 2012, 53 patients (56±15 years, male:female =14:39) underwent tricuspid reoperations due to recurrent tricuspid regurgitation (TR) after initial repair. Twenty-two patients underwent tricuspid re-repair (TAP group) and 31 patients underwent TVR (TVR group). Results Early mortality occurred in 6 patients (11%). Early mortality and incidence of postoperative complications were similar between the 2 groups. There were 14 cases of late mortality including 9 cardiac deaths. Five- and 10-year free from cardiac death rates were 82% and 67%, respectively, without any intergroup difference. Recurrent TR (> moderate) developed in 6 TAP group patients and structural valve deterioration occurred in 1 TVR group patient (P=0.002). Isolated tricuspid valve surgery (P=0.044) and presence of atrial fibrillation during the follow-up (P=0.051) were associated with recurrent TR after re-repair. However, the overall tricuspid valve-related event rates were similar between the 2 groups with 5- and 10-year rates of 61% and 41%, respectively. Conclusions Tricuspid valve reoperation after initial repair resulted in high rates of operative mortality and complications. Long-term event-free rate was similar regardless of the type of surgery. However, great care might be needed when performing re-repair in patients with atrial fibrillation and those who had isolated tricuspid valve disease due to high recurrence of TR after re-repair. PMID:26904221

Prosthetic valve sparing aortic root replacement: an improved technique.

PubMed

Leacche, Marzia; Balaguer, Jorge M; Umakanthan, Ramanan; Byrne, John G

2008-10-01

We describe a modified surgical technique to treat patients with a previous history of isolated aortic valve replacement who now require aortic root replacement for an aneurysmal or dissected aorta. This technique consists of replacing the aortic root with a Dacron conduit, leaving intact the previously implanted prosthesis, and re-implanting the coronary arteries in the Dacron graft. Our technique differs from other techniques in that we do not leave behind any aortic tissue remnant and also in that we use a felt strip to obliterate any gap between the old sewing ring and the newly implanted graft. In our opinion, this promotes better hemostasis. We demonstrate that this technique is safe, feasible, and results in acceptable outcomes.

Longevity after aortic root replacement: is the mechanically valved conduit really the gold standard for quinquagenarians?

PubMed

Etz, Christian D; Girrbach, Felix F; von Aspern, Konstantin; Battellini, Roberto; Dohmen, Pascal; Hoyer, Alexandro; Luehr, Maximilian; Misfeld, Martin; Borger, Michael A; Mohr, Friedrich W

2013-09-10

The choice of the best conduit for root/ascending disease and its impact on longevity remain controversial in quinquagenarians. A total of 205 patients (men=155) between 50 and 60 years (mean, 55.7 ± 2.9 years) received either a stentless porcine xenoroot (n=78) or a mechanically valved composite prosthesis (n=127) between February 1998 and July 2011. Of these, 166 patients underwent root replacement for aneurysmal disease (porcine: 39% [n=65]; mechanical: 61% [n=101]; P=0.5), 25 for acute type A aortic dissection (porcine: 32% [n=8]; mechanical: 68% [n=17]; P=0.51), and 14 for endocarditis/iatrogenic injury involving the aortic root (6.4% [n=5] versus 7.1% [n=9]; P=1.0). The predominant aortic valve pathology was stenosis in 19% (n=38), regurgitation in 50% (n=102), combined valvular dysfunction in 26% (n=54), and normal aortic valve function in 5% (n=11). Concomitant procedures included coronary artery bypass grafting (13%), mitral valve repair (7%), and partial/complete arch replacement (12%/4%), with no significant differences between porcine and mechanical root replacement. Overall hospital mortality was 7.3%, with no difference between the 2 types of valve prostheses (7.7% for porcine and 7.1% for mechanical root replacement; P=1.0). Follow-up averaged 5.4 ± 3.7 years (1096 patient-years) and was 100% complete. Freedom from aorta-related reoperation at 12 years was not statistically different between the groups (porcine: 94.9% versus mechanical: 96.1%; P=0.73). Survival was equivalent between both groups, with a 5-year survival of 86 ± 3% (porcine: 88 ± 4%; mechanical: 85 ± 3%; P=0.96) and a 10-year survival of 76% (porcine: 80 ± 7%; mechanical: 75 ± 5%; P=0.84). The linearized mortality rate was 3.1%/patient-year (porcine: 2.9%/patient-year; mechanical: 3.2%/patient-year). In quinquagenerians, long-term survival after stentless porcine xenograft aortic root replacement is equivalent to that after a mechanical Bentall procedure. These results bring

Dynamic Course of Serratia marcescens Pulmonic Valve Endocarditis Resulting in Submassive PE and Valve Replacement.

PubMed

Meyer, Chloe Grace; Vacek, Thomas Paul; Bansal, Amit; Gurujal, Ravi; Parikh, Analkumar

2018-01-01

This report illustrates a case of a 42-year-old male with a history of intravenous drug abuse who presented with septic shock. Diagnostic studies, including a transthoracic echocardiogram, chest computed tomography angiography, transesophageal echocardiogram, and blood cultures ultimately revealed Serratia marcescens pulmonic valve infective endocarditis that was treated with intravenous antibiotics. In addition to the rare form of endocarditis and bacterium involved, this case brings into awareness the dynamic nature of the hospital course that requires vigilance in responding to hypotensive episodes for consideration of pulmonary embolism. Surgical valve replacement was opted for due to such a complication in addition to the large size of the vegetation, 2.5 cm.

Aortic valve replacement using continuous suture technique in patients with aortic valve disease.

PubMed

Choi, Jong Bum; Kim, Jong Hun; Park, Hyun Kyu; Kim, Kyung Hwa; Kim, Min Ho; Kuh, Ja Hong; Jo, Jung Ku

2013-08-01

The continuous suture (CS) technique has several advantages as a method for simple, fast, and secure aortic valve replacement (AVR). We used a simple CS technique without the use of a pledget for AVR and evaluated the surgical outcomes. Between October 2007 and 2012, 123 patients with aortic valve disease underwent AVR alone (n=28) or with other concomitant cardiac procedures (n=95), such as mitral, tricuspid, or aortic surgery. The patients were divided into two groups: the interrupted suture (IS) group (n=47), in which the conventional IS technique was used, and the CS group (n=76), in which the simple CS technique was used. There were two hospital deaths (1.6%), which were not related to the suture technique. There were no significant differences in cardiopulmonary bypass time or aortic cross-clamp time between the two groups for AVR alone or AVR with concomitant cardiac procedures. In the IS group, two patients had prosthetic endocarditis and one patient experienced significant perivalvular leak. These patients underwent reoperations. In the CS group, there were no complications related to the surgery. Postoperatively, the two groups had similar aortic valve gradients. The simple CS method is useful and secure for AVR in patients with aortic valve disease, and it may minimize surgical complications, as neither pledgets nor braided sutures are used.

Long-term survival, valve durability, and reoperation for 4 aortic root procedures combined with ascending aorta replacement.

PubMed

Svensson, Lars G; Pillai, Saila T; Rajeswaran, Jeevanantham; Desai, Milind Y; Griffin, Brian; Grimm, Richard; Hammer, Donald F; Thamilarasan, Maran; Roselli, Eric E; Pettersson, Gösta B; Gillinov, A Marc; Navia, Jose L; Smedira, Nicholas G; Sabik, Joseph F; Lytle, Bruce W; Blackstone, Eugene H

2016-03-01

To evaluate long-term results of aortic root procedures combined with ascending aorta replacement for aneurysms, using 4 surgical strategies. From January 1995 to January 2011, 957 patients underwent 1 of 4 aortic root procedures: valve preservation (remodeling or modified reimplantation, n = 261); composite biologic graft (n = 297); composite mechanical graft (n = 156); or allograft root (n = 243). Seven deaths occurred (0.73%), none after valve-preserving procedures, and 13 strokes (1.4%). Composite grafts exhibited higher gradients than allografts or valve preservation, but the latter 2 exhibited more aortic regurgitation (2.7% biologic and 0% mechanical composite grafts vs 24% valve-preserving and 19% allografts at 10 years). Within 2 to 5 years, valve preservation exhibited the least left ventricular hypertrophy, allograft replacement the greatest; however, valve preservation had the highest early risk of reoperation, allograft replacement the lowest. Patients receiving allografts had the highest risk of late reoperation (P < .05), and those receiving composite mechanical grafts and valve preservation had the lowest. Composite bioprosthesis patients had the highest risk of late death (57% at 15 years vs 14%-26% for the remaining procedures, P < .0001), because they were substantially older and had more comorbidities (P < .0001). These 4 aortic root procedures, combined with ascending aorta replacement, provide excellent survival and good durability. Valve-preserving and allograft procedures have the lowest gradients and best ventricular remodeling, but they have more late regurgitation, and likely, less risk of valve-related complications, such as bleeding, hemorrhage, and endocarditis. Despite the early risk of reoperation, we recommend valve-preserving procedures for young patients when possible. Composite bioprostheses are preferable for the elderly. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights

Is mitral valve repair superior to replacement for chronic ischemic mitral regurgitation with left ventricular dysfunction?

PubMed Central

2010-01-01

Background This study was undertaken to compare mitral valve repair and replacement as treatments for ischemic mitral regurgitation (IMR) with left ventricular dysfunction (LVD). Specifically, we sought to determine whether the choice of mitral valve procedure affected survival, and discover which patients were predicted to benefit from mitral valve repair and which from replacement. Methods A total of 218 consecutive patients underwent either mitral valve repair (MVP, n = 112) or mitral valve replacement (MVR, n = 106). We retrospectively reviewed the clinical material, operation methods, echocardiography check during operation and follow-up. Patients details and follow-up outcomes were compared using multivariate and Kaplan-Meier analyses. Results No statistical difference was found between the two groups in term of intraoperative data. Early mortality was 3.2% (MVP 2.7% and MVR 3.8%). At discharge, Left ventricular end-systolic and end-diastolic diameter and left ventricular ejection fraction (LVEF) were improved more in the MVP group than MVR group (P < 0.05), however, in follow-up no statistically significant difference was observed between the MVR and MVP group (P > 0.05). Follow-up mitral regurgitation grade was significantly improved in the MVR group compared with the MVP group (P < 0.05). The Kaplan-Meier survival estimates at 1, 3, and 5 years were simlar between MVP and MVR group. Logistic regression revealed poor survival was associated with old age(#75), preoperative renal insufficiency and low left ventricular ejection fraction (< 30%). Conclusion Mitral valve repair is the procedure of choice in the majority of patients having surgery for severe ischemic mitral regurgitation with left ventricular dysfunction. Early results of MVP treatment seem to be satisfactory, but several lines of data indicate that mitral valve repair provided less long-term benefit than mitral valve replacement in the LVD patients. PMID:21059216

Long-Term Risk for Aortic Complications After Aortic Valve Replacement in Patients With Bicuspid Aortic Valve Versus Marfan Syndrome.

PubMed

Itagaki, Shinobu; Chikwe, Joanna P; Chiang, Yuting P; Egorova, Natalia N; Adams, David H

2015-06-09

Bicuspid aortic valves are associated with valve dysfunction, ascending aortic aneurysm and dissection. Management of the ascending aorta at the time of aortic valve replacement (AVR) in these patients is controversial and has been extrapolated from experience with Marfan syndrome, despite the absence of comparative long-term outcome data. This study sought to assess whether the natural history of thoracic aortopathy after AVR in patients with bicuspid aortic valve disease is substantially different from that seen in patients with Marfan syndrome. In this retrospective comparison, outcomes of 13,205 adults (2,079 with bicuspid aortic valves, 73 with Marfan syndrome, and 11,053 control patients with acquired aortic valve disease) who underwent primary AVR without replacement of the ascending aorta in New York State between 1995 and 2010 were compared. The median follow-up time was 6.6 years. The long-term incidence of thoracic aortic dissection was significantly higher in patients with Marfan syndrome (5.5 ± 2.7%) compared with those with bicuspid valves (0.55 ± 0.21%) and control group patients (0.41 ± 0.08%, p < 0.001). Thoracic aortic aneurysms were significantly more likely to be diagnosed in late follow-up in patients with Marfan syndrome (10.8 ± 4.4%) compared with those with bicuspid valves (4.8 ± 0.8%) and control group patients (1.4 ± 0.2%) (p < 0.001). Patients with Marfan syndrome were significantly more likely to undergo thoracic aortic surgery in late follow-up (10.4 ± 4.3%) compared with those with bicuspid valves (2.5 ± 0.6%) and control group patients (0.50 ± 0.09%) (p < 0.001). The much higher long-term rates of aortic complications after AVR observed in patients with Marfan syndrome compared with those with bicuspid aortic valves confirm that operative management of patients with bicuspid aortic valves should not be extrapolated from Marfan syndrome and support discrete treatment algorithms for these different clinical entities

Cost-effectiveness considerations in transcatheter management of valvular heart disease.

PubMed

Gadey, Gautam; Reynolds, Matthew R

2014-09-01

In 2011, health care spending in Canada accounted for 11.2% of gross domestic product. Increased life expectancy, combined with the fact that new medical technologies generally tend to improve clinical results at an increased cost, are leading developed nations to devote rising amounts of financial resources to health care. Valvular heart disease is an example of an age-related health problem with rising prevalence that has recently seen an emergence of new catheter-based technologies, which are rapidly changing the treatment landscape. This article reviews the current literature on the health economics of catheter-based valve therapies. Transcatheter aortic valve replacement (TAVR), a less invasive approach to valve replacement, is currently approved in the United States, Canada, and Europe for 2 groups of patients: those with symptomatic severe aortic stenosis who are unsuitable for surgery and those who are suitable but are at high risk for surgery. TAVR, when compared with medical therapy, results in significant improvement in survival for inoperable patients, with incremental costs that are generally considered to be acceptable in most western nations. However, in high-risk surgical candidates, TAVR has shown similar survival rates when compared with surgical aortic valve replacement, with only short-term advantages in quality of life. Cost-effectiveness ratios in this population have varied widely based on differing estimates of incremental costs. Information regarding the health economics of transcatheter mitral valve therapies is still quite preliminary and limited to the MitraClip (Abbott Laboratories, Abbott Park, IL). Ongoing trials should provide additional information about the health economics of this new technology. Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Posterior leaflet preservation during mitral valve replacement for rheumatic mitral stenosis.

PubMed

Djukić, P L; Obrenović-Kirćanski, B B; Vranes, M R; Kocica, M J; Mikić, A Dj; Velinović, M M; Kacar, S M; Kovacević, N S; Parapid, B J

2006-01-01

Mitral valve replacement with posterior leaflet preservation was shown beneficial for postoperative left vetricular (LV) performance in patients with mitral regurgitation. Some authors find it beneficial even for the long term LV function. We investigated a long term effect of this technique in patients with rheumatic mitral stenosis. We studied 20 patents with mitral valve replacement due to rheumatic mitral stenosis, in the period from January 1988 to December 1989. In group A (10 patients) both leaflets and coresponding chordal excision was performed, while in group B (10 patients) the posterior leaflet was preserved. In all patients a Carbomedics valve was inserted. We compared clinical pre and postoperative status, as well as hemodynamic characteristics of the valve and left ventricle in both groups. Control echocardiographyc analysis included: maximal (PG) and mean (MG) gradients; effective valve area (AREA); telediastolic (TDV) and telesystolic (TSV) LV volume; stroke volume (SV); ejection fraction (EF); fractional shortening (FS) and segmental LV motion. The mean size of inserted valve was 26.6 in group A and 27.2 in group B. Hemodynamic data: PG (10.12 vs 11.1); MG (3.57 vs 3.87); AREA (2.35 vs 2.30); TDV 126.0 vs 114.5); TSV (42.2 vs 36.62); SV (83.7 vs 77.75); EF (63.66 vs 67.12); FS (32.66 vs 38.25). Diaphragmal segmental hypokinesis was evident in one patient from group A and in two patients from group B. In patients with rheumatic stenosis, posterior leaflet preservation did not have increased beneficial effect on left ventricular performance during long-term follow-up. An adequate posterior leaflet preservation does not change hemodynamic valvular characteristics even after long-term follow-up.

Aortic valve replacement and concomitant right coronary artery bypass grafting performed via a right minithoracotomy approach.

PubMed

Mihos, Christos G; Santana, Orlando; Pineda, Andres M; La Pietra, Angelo; Lamelas, Joseph

2014-01-01

We present our experience of concomitant right coronary artery bypass grafting (CABG) and aortic valve replacement performed via a right minithoracotomy in patients with coronary lesions not amenable to percutaneous intervention. A total of 17 patients underwent concomitant aortic valve replacement and right CABG between April 2008 and July 2013. A 5- to 6-cm minithoracotomy incision was made over the right second or third intercostal space, and the costochondral cartilage was transected. A saphenous vein bypass to the right coronary artery was then performed, initiating the anastomosis from the toe of the graft. Subsequently, the aortic valve was replaced using standard techniques. There were 6 men and 11 women. The median European System for Cardiac Operative Risk Evaluation II score mortality risk was 5% [interquartile range (IQR), 2%-8%]. The mean (SD) age was 77 (10) years, the left ventricular ejection fraction was 59% (8%), and the New York Heart Association functional class was 2.4 (0.8). One patient had a history of CABG. The mean (SD) cardiopulmonary bypass time was 168 (57) minutes, and the aortic cross-clamp time was 133 (36) minutes. Three patients underwent concomitant mitral valve surgery (replacement, 2; repair, 1). The median intensive care unit and hospital lengths of stay were 47 hours (IQR, 24-90) and 9 days (IQR, 5-13), respectively. There was one reoperation for bleeding, and there was one postoperative stroke. All patients were alive at a mean (SD) follow-up of 2 (1.1) years. Aortic valve replacement with concomitant CABG performed via a right minithoracotomy approach is feasible.

Hemodynamic deterioration after aortic valve replacement in a patient with mixed systemic amyloidosis.

PubMed

Seki, Tatsuya; Hattori, Atsuo; Yoshida, Toshihito

2017-08-01

We report a case of hemodynamic deterioration after aortic valve replacement in a patient with mixed systemic amyloidosis. A 77-year-old male with severe aortic valve stenosis and 19 years hemodialysis underwent aortic valve replacement. Postoperatively, the patient died of hemodynamic deterioration. Autopsy findings showed massive, whole-body edema and mixed systemic amyloidosis (dialysis-related and AA amyloidosis). Clinical and autopsy findings implied that hemodynamic deterioration was caused by increased vascular permeability. The amyloid deposit to the vessel causes inflammatory changes and increases vascular permeability. Mixed systemic amyloidosis occurs very rarely and could increases vascular permeability even more than each single type of amyloidosis. Systemic amyloidosis may be a risk factor for hemodynamic deterioration after cardiac surgery. Patients with longtime hemodialysis and a history associated with dialysis-related amyloidosis would have at least single systemic amyloidosis, which should be considered a contraindication to cardiac surgery with cardiopulmonary bypass.

Left Ventricular Assist Device Implantation with Concomitant Aortic Valve and Ascending Aortic Replacement.

PubMed

Huenges, Katharina; Panholzer, Bernd; Cremer, Jochen; Haneya, Assad

2018-01-01

Left ventricular assist device (LVAD) is nowadays a routine therapy for patients with advanced heart failure. We present the case of a 74-year-old male patient who was admitted to our center with terminal heart failure in dilated cardiomyopathy and ascending aortic aneurysm with aortic valve regurgitation. The LVAD implantation with simultaneous aortic valve and supracoronary ascending aortic replacement was successfully performed.

Aortic cusp extension valvuloplasty with or without tricuspidization in children and adolescents: long-term results and freedom from aortic valve replacement.

PubMed

Polimenakos, Anastasios C; Sathanandam, Shyam; Elzein, Chawki; Barth, Mary J; Higgins, Robert S D; Ilbawi, Michel N

2010-04-01

Aortic cusp extension valvuloplasty is increasingly used in the management of children and adolescents with aortic stenosis or regurgitation. The durability of this approach and the freedom from valve replacement are not well defined. A study was undertaken to investigate outcomes. From July 1987 to November 2008, 142 patients aged less than 19 years underwent aortic cusp extension valvuloplasty in the form of pericardial cusp extension and tricuspidization (when needed). Three patients with truncus arteriosus and severe truncal valve insufficiency were excluded. From the available follow-up data of 139 patients, 50 had bicuspid aortic valves, 40 had congenital aortic valve stenosis, 41 had combined congenital aortic valve stenosis/insufficiency, and 8 had other diagnoses. Median follow-up was 14.4 years (0.1-21.4). Long-term mortality and freedom from aortic valve replacement were studied. There were no early, intermediate, or late deaths. Z-values of left ventricular end-diastolic dimension, aortic annulus, aortic sinus diameter, and sinotubular junction diameter before aortic valve replacement were 4.2 +/- 3.11, 2.3 +/- 1.25, 4.4 +/- 1.23, and 1.84 +/- 1.28, respectively. During the follow-up period, 64 patients underwent aortic valve reinterventions. The Ross procedure was performed in 32 of 139 patients (23%) undergoing aortic cusp extension valvuloplasty. Other aortic valve replacements were undertaken after 16 aortic cusp extension valvuloplasties (11.5%). Freedom from a second aortic cusp extension valvuloplasty or aortic valve replacement at 18 years was 82.1% +/- 4.2% and 60.0% +/- 7.2%, respectively. Aortic cusp extension valvuloplasty is a safe and effective surgical option with excellent survival and good long-term outcomes in children and adolescents. The procedure provides acceptable durability and satisfactory freedom from aortic valve replacement. Copyright 2010 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights

Illness Perception Profiles and Their Association with 10-Year Survival Following Cardiac Valve Replacement.

PubMed

Crawshaw, Jacob; Rimington, Helen; Weinman, John; Chilcot, Joseph

2015-10-01

The aim of the present study was to examine whether profiles of illness perceptions are associated with 10-year survival following cardiac valve replacement surgery. Illness perceptions were evaluated in 204 cardiac patients awaiting first-time valve replacement and again 1 year post-operatively using cluster analysis. All-cause mortality was recorded over a 10-year period. At 1 year, 136 patients were grouped into one of four profiles (stable positive, stable negative, changed from positive to negative, changed from negative to positive). The median follow-up was 3063 days (78 deaths). After controlling for clinical covariates, including markers of function, patients who changed illness perceptions from positive to negative beliefs 1 year post-surgery had an increased mortality risk (hazard ratio (HR) = 3.2, 95% confidence interval (CI) 1.2-8.3, p = .02) compared to patients who held positive stable perceptions. Following cardiac valve replacement, developing negative illness perceptions over the first post-operative year predicts long-term mortality. Early screening and intervention to alter this pattern of beliefs may be beneficial.

Twin Valve Caval Stent for Functional Replacement of Incompetent Tricuspid Valve: A Feasibility Animal Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sochman, Jan, E-mail: jan.sochman@medicon.cz; Peregrin, Jan H., E-mail: jape@medicon.cz; Pavcnik, Dusan, E-mail: pavcnikd@ohsu.edu

Objective: To evaluate feasibility of a twin valve caval stent (TVCS) for functional replacement of an incompetent tricuspid valve (TV) in an acute animal study. Methods: One swine and three sheep were used in the study. TVCS placement was tested in a swine with a normal TV. TVCS function was tested in three sheep with TV regurgitation created by papillary muscle avulsion. Cardiac angiograms and pressure measurements were used to evaluate TVCS function. Two sheep were studied after fluid overload. Results: TVCS was percutaneously placed properly at the central portions of the superior vena cava (SVC) and inferior vena cavamore » (IVC) in the swine. Papillary muscle avulsion in three sheep caused significant tricuspid regurgitation with massive reflux into the right atrium (RA) and partial reflux into the SVC and IVC. TVCS placement eliminated reflux into the SVC and IVC. After fluid overload, there was enlargement of the right ventricle and RA and significant increase in right ventricle, RA, SVC, and IVC pressures, but no reflux into the IVC and SVC. Conclusion: The results of this feasibility study justify detailed evaluation of TVCS insertion for functional chronic replacement of incompetent TV.« less

The valve choice in tricuspid valve replacement: 25 years of experience.

PubMed

Van Nooten, G J; Caes, F L; François, K J; Taeymans, Y; Primo, G; Wellens, F; Leclerq, J L; Deuvaert, F E

1995-01-01

This study reviews 146 consecutive patients who underwent tricuspid valve replacement (TVR) with 69 bioprostheses (porcine and bovine pericardial) and 77 mechanical ball, disc or bileaflet valves between 1967 and 1987. The mean age was 51.4 +/- 12.1 years. Preoperatively, 97% were in New York Heart Association (NYHA) functional class III or more and over 40% had undergone previous cardiac surgery. Hospital mortality was high (16.1%). Incremental risk factors for hospital death were preoperative icterus (P < 0.01), hepatomegaly (P = 0.02), NYHA functional class IV (P = 0.02) and male sex (P = 0.04) (univariate analysis). Ninety-eight percent of the hospital survivors were followed up for a mean of 92 months. Cumulative follow-up added up to 955 patient-years. There were 70 late deaths. The actuarial survival rate was 74% at 60 months and less than 25% at 14 years. Incremental risk factors for late death indicated by univariate analysis were the type of tricuspid prosthesis (Smel-off-Cutter and Kay-Shiley prostheses) (P = 0.04), the type of operative myocardial protection (normothermia and coronary perfusion) (P = 0.05) and preoperative NYHA functional class IV (P = 0.05). We conclude that TVR carries a high operative risk and poor long-term survival, both influenced by preoperative and perioperative variables. Bearing in mind the poor prognosis for TVR, we prefer a large-sized bioprosthesis, in view of its initial good durability and low risk of valve-related events. However, in patients with good life expectancy, a bileaflet mechanical prosthesis may be an acceptable alternative.

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

PubMed

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

2017-11-01

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

Left Ventricular Assist Device Implantation with Concomitant Aortic Valve and Ascending Aortic Replacement

PubMed Central

Panholzer, Bernd; Cremer, Jochen; Haneya, Assad

2018-01-01

Left ventricular assist device (LVAD) is nowadays a routine therapy for patients with advanced heart failure. We present the case of a 74-year-old male patient who was admitted to our center with terminal heart failure in dilated cardiomyopathy and ascending aortic aneurysm with aortic valve regurgitation. The LVAD implantation with simultaneous aortic valve and supracoronary ascending aortic replacement was successfully performed. PMID:29552039

Cold crystalloid versus warm blood cardioplegia in patients undergoing aortic valve replacement.

PubMed

Nardi, Paolo; Vacirca, Sara R; Russo, Marco; Colella, Dionisio F; Bassano, Carlo; Scafuri, Antonio; Pellegrino, Antonio; Melino, Gerry; Ruvolo, Giovanni

2018-03-01

Myocardial protection techniques during cardiac arrest have been extensively investigated in the clinical setting of coronary revascularization. Fewer studies have been carried out of patients affected by left ventricular hypertrophy, where the choice of type and temperature of cardioplegia remain controversial. We have retrospectively investigated myocardial injury and short-term outcome in patients undergoing aortic valve replacement plus or minus coronary artery bypass grafting with using cold crystalloid cardioplegia (CCC) or warm blood cardioplegia (WBC). From January 2015 to October 2016, 191 consecutive patients underwent aortic valve replacement plus or minus coronary artery bypass grafting in normothermic cardiopulmonary bypass. Cardiac arrest was obtained with use of intermittent antegrade CCC group (n=32) or WBC group (n=159), according with the choice of the surgeon. As compared with WBC group, in CCC group creatine-kinase-MB (CK-MB), cardiac troponin I (cTnI), aspartate aminotransferase (AST) release, and their peak levels, were lower during each time points of evaluation, with the greater statistically significant difference at time 0 (P<0.05, for all comparisons). A time 0, CK-MB/CK ratio >10% was 5.9% in CCC group versus 7.8% in WBC group (P<0.0001). At time 0 CK-MB/CK ratio >10% in patients undergoing isolated aortic valve replacement was 6.0% in CCC group versus 8.0% in WBC group (P<0.01). No any difference was found in perioperative myocardial infarction (0% versus 3.8%), postoperative (PO) major complications (15.6% versus 16.4%), in-hospital mortality (3.1% versus 1.3%). In aortic valve surgery a significant decrease of myocardial enzymes release is observed in favor of CCC, but this difference does not translate into different clinical outcome. However, this study suggests that in presence of cardiac surgical conditions associated with significant left ventricular hypertrophy, i.e., the aortic valve disease, a better myocardial protection can

Mitral annular calcification in patients undergoing aortic valve replacement for aortic valve stenosis.

PubMed

Takami, Yoshiyuki; Tajima, Kazuyoshi

2016-02-01

Limited data exis t on clinical relevance of aortic valve stenosis (AVS) and mitral annular calcification (MAC), although with similar pathophysiologic basis. We sought to reveal the prevalence of MAC and its clinical features in the patients undergoing aortic valve replacement (AVR) for AVS. We reviewed 106 consecutive patients who underwent isolated AVR from 2004 to 2010. Before AVR, CT scans were performed to identify MAC, whose severity was graded on a scale of 0-4, with grade 0 denoting no MAC and grade 4 indicating severe MAC. Echocardiography was performed before AVR and at follow-up over 2 years after AVR. MAC was identified in 56 patients with grade 1 (30 %), 2 (39 %), 3 (18 %), and 4 (13 %), respectively. Patients with MAC presented older age (72 ± 8 versus 66 ± 11 years), higher rate of dialysis-dependent renal failure (43 versus 4 %), and less frequency of bicuspid aortic valve (9 versus 36 %), when compared to those without MAC. No significant differences were seen in short- and mid-term mortality after AVR between the groups. In patients with MAC, progression of neither mitral regurgitation nor stenosis was observed at follow-up of 53 ± 23 months for 102 survivors, although the transmitral flow velocities were higher than in those without MAC. In conclusion, MAC represented 53 % of the patients undergoing isolated AVR for AVS, usually appeared in dialysis-dependent elder patients with tricuspid AVS. MAC does not affect adversely upon the survival, without progression of mitral valve disease, at least within 2 years after AVR.

Percutaneous Transcatheter Mitral Valve Replacement: Patient-specific Three-dimensional Computer-based Heart Model and Prototyping.

PubMed

Vaquerizo, Beatriz; Theriault-Lauzier, Pascal; Piazza, Nicolo

2015-12-01

Mitral regurgitation is the most prevalent valvular heart disease worldwide. Despite the widespread availability of curative surgical intervention, a considerable proportion of patients with severe mitral regurgitation are not referred for treatment, largely due to the presence of left ventricular dysfunction, advanced age, and comorbid illnesses. Transcatheter mitral valve replacement is a promising therapeutic alternative to traditional surgical valve replacement. The complex anatomical and pathophysiological nature of the mitral valvular complex, however, presents significant challenges to the successful design and implementation of novel transcatheter mitral replacement devices. Patient-specific 3-dimensional computer-based models enable accurate assessment of the mitral valve anatomy and preprocedural simulations for transcatheter therapies. Such information may help refine the design features of novel transcatheter mitral devices and enhance procedural planning. Herein, we describe a novel medical image-based processing tool that facilitates accurate, noninvasive assessment of the mitral valvular complex, by creating precise three-dimensional heart models. The 3-dimensional computer reconstructions are then converted to a physical model using 3-dimensional printing technology, thereby enabling patient-specific assessment of the interaction between device and patient. It may provide new opportunities for a better understanding of the mitral anatomy-pathophysiology-device interaction, which is of critical importance for the advancement of transcatheter mitral valve replacement. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

[Short and long term results of aortic valve replacement in patients 80 years of age and older].

PubMed

Mortasawi, A; Gehle, S; Yaghmaie, M; Schröder, T; Ennker, I C; Rosendahl, U; Albert, A; Ennker, J

2001-03-01

Due to demographic changes in average life expectancy the age of patients undergoing cardiac surgery is increasing as well. We have reviewed the short- and long-term outcome in patients over 80 years of age after aortic valve replacement with or without concomitant coronary grafting. From 1.1.1995 until 31.12.1999, 126 patients (93 women, 33 men between 80 and 89 years, 82.8 +/- 2.4) underwent aortic valve replacement. 64 patients (group A) received isolated valve replacement, 62 (group B) underwent myocardial revascularization as well. The 30-day hospital mortality rate was 6.3% for group A and 14.5% for group B. The follow-up time ranged between 3 and 63 months (32 +/- 16). None of the patients had to be reoperated for prosthetic valve dysfunction or endocarditis. Bleeding complications due to anticoagulation therapy were observed by one patient from group A 3 years after the operation. Of the 15 deaths during the follow-up period seven (47%) were cardiac in nature and two (13%) related to stroke. Acturial survival rates for group A were 89%, 85% and 77% at 1, 2 and 3 years, and for group B 76%, 72% and 70%. Permanent nursing care was not required 1 year after the operation by 100% of patients in group A (2 years: 98%, 3 years 95%) and by 100% of patients in group B (2 years: 93%, 3 years: 90%). At an interval of 1 year after the operation 96% of patients in group A had not been hospitalized as a result of cardiac disorders (2 years: 96%, 3 years: 94%). The rates for group B were 88%, 81% and 75%. Compared with younger age groups, aortic valve replacement in patients 80 years of age and older is associated with a distinctly increased mortality and morbidity. However, our data suggest that considering the poor prognosis of conservative therapy of symptomatic aortic valve disease, functional status as well as life expectancy in this age group seem to be positively influenced by aortic valve replacement.

Midterm results after aortic valve replacement with freehand stentless xenografts: a comparison of three prostheses.

PubMed

Luciani, G B; Bertolini, P; Vecchi, B; Mazzucco, A

1998-06-01

The ideal substitute for the diseased aortic valve is yet to be found. For the assessment and comparison of the midterm results after aortic valve replacement with three different types of freehand stentless xenografts, all patients who underwent the operation between October 1992 and April 1997 were reviewed. Of 231 patients undergoing aortic valve replacement, 106 patients (group 1) were given the Biocor PSB (Biocor Industria e Pesquisa Ltda, Belo Horizonte, MG, Brazil); 76 patients (group 2) were given the Toronto SPV (St. Jude Medical, Inc., St. Paul, Minn.), and 49 patients (group 3) were given the O'Brien-Angell valve (Bravo Cardiovascular model 300, Cryolife, Inc., Marietta, Ga.). The first two xenografts require inflow and outflow suturelines; the third xenograft needs a single-sutureline implantation. Mean age (70 +/- 6 years; 70 +/- 7 years; 72 +/- 9 years; p = 0.6), prevalence of male sex (56 patients, 53%; 37 patients, 49%; 22 patients, 45%; p = 0.7), of aortic stenosis (72 patients, 68%; 54 patients, 71%; 37 patients, 73%; p = 0.6), and need for associated procedures (51 patients, 48%; 30 patients, 40%; 21 patients, 43%; p = 0.1) were comparable among groups. Mean aortic crossclamp time was shorter in group 3 (96 +/- 24 minutes; 100 +/- 23 minutes; 88 +/- 25 minutes;p = 0.01). Early deaths were 3 of 106 (3%) in group 1, 2 of 76 (3%) in group 2, and 2 of 49 (4%) in group 3. Follow-up of survivors ranged from 1 to 54 months (mean 32 +/- 13 months). Survival at 4 years was 90% +/- 3% in group 1, 95% +/- 3% in group 2, 85% +/- 8% in group 3 (p = 0.3). At 4 years, freedom from valve-related events was 95% +/- 6%, 100%, 70% +/- 8% (p = 0.004), while freedom from valve deterioration was 99% +/- 1%, 100%, 73% +/- 8% (p = 0.001), in group 1, 2, and 3, respectively (p = 0.001). At follow-up, reintervention on the xenograft was necessary in one patient (endocarditis) in group 1, none in group 2, and six in group 3 (technical cause, group 3; valve tear, group 2

Computerized system for the follow-up of patients with heart valve replacements.

PubMed

Bain, W H; Fyfe, I C; Rodger, R A

1985-04-01

A system is described which will accept, store, retrieve and analyze information on large numbers of patients who undergo valve replacement surgery. The purpose of the database is to yield readily available facts concerning the patient's clinical course, prosthetic valve function, length of survival, and incidence of complications. The system uses the Apple Macintosh computer, which is one of the current examples of small, desk-top microprocessors. The software for the input, editing and analysis programs has been written by a professional software writer in close collaboration with a cardiac surgeon. Its content is based on 8 years' experience of computer-based valve follow-up. The system is inexpensive and has proved easy to use in practice.

Association of Transcatheter Aortic Valve Replacement With 30-Day Renal Function and 1-Year Outcomes Among Patients Presenting With Compromised Baseline Renal Function: Experience From the PARTNER 1 Trial and Registry.

PubMed

Beohar, Nirat; Doshi, Darshan; Thourani, Vinod; Jensen, Hanna; Kodali, Susheel; Zhang, Feifan; Zhang, Yiran; Davidson, Charles; McCarthy, Patrick; Mack, Michael; Kapadia, Samir; Leon, Martin; Kirtane, Ajay

2017-07-01

The frequency of baseline renal impairment among high-risk and inoperable patients with severe aortic stenosis undergoing a transcatheter aortic valve replacement (TAVR) and the effect of TAVR on subsequent renal function are, to our knowledge, unknown. To determine the effect of TAVR among patients with baseline renal impairment. This substudy of patients with baseline renal impairment (estimated glomerular filtration rate [eGFR] ≤ 60 mL/min) and paired baseline and 30-day measures of renal function undergoing TAVR in the PARTNER 1 trial and continued access registries was conducted in 25 centers in the United States and Canada. Patients were categorized with improved eGFR (30-day follow-up eGFR≥10% higher than baseline pre-TAVR), worsened eGFR (≥10% lower), or no change in renal function (neither). Baseline characteristics, 30-day to 1-year all-cause mortality, and repeat hospitalization were compared. Multivariable models were constructed to identify predictors of 1-year mortality and of improvement/worsening in eGFR. Of the 821 participants, 401 (48.8%) were women and the mean (SD) age for participants with improved, unchanged, or worsening eGFR was 84.90 (6.91) years, 84.37 (7.13) years, and 85.39 (6.40) years, respectively. The eGFR was 60 mL/min or lower among 821 patients (72%), of whom 345 (42%) improved, 196 (24%) worsened, and 280 (34%) had no change at 30 days. There were no differences in baseline age, body mass index, diabetes, chronic obstructive pulmonary disease, coronary artery disease, peripheral arterial disease, hypertension, pulmonary hypertension, renal or liver disease, New York Heart Association III/IV symptoms, transaortic gradient, left ventricular ejection fraction, or procedural characteristics. The group with improved eGFR had more women, nonsmokers, and a lower cardiac index. Those with worsening eGFR had a higher median Society of Thoracic Surgeons score and left ventricle mass. From 30 days to 1 year, those with improved e

Late-term results of mitral valve replacement with St. Jude Medical mechanical valve prosthesis: Samsun experience.

PubMed

Demirag, Mustafa Kemal; Keceligil, Hasan Tahsin; Kolbakir, Fersat

2006-10-01

We have reported the short- and long-term results of mitral valve replacement in this article. Mitral valve replacement was conducted in 276 patients in our clinic between January 1989 and March 2005. The youngest patient was 4 years old and the oldest patient was 74 years old. Mean age was 40.08 +/- 1.06 y. Of these patients, 41.3% were men and 58.7% were women. The reason for operation was mitral stenosis in 96 patients (34.78%), mitral insufficiency in 78 patients (29.26%) and mitral stenosis plus mitral insufficiency in 102 patients (36.96%). The aetiology of mitral valve lesions was acute rheumatic fever in 208 patients (75.36%). The aetiology of mitral valve lesions was degenerative in 37 patients (13.41%), ischaemic in 23 patients (8.33%) and congenital in 8 patients (2.9%). In the 5, 10 and 15-year periods, the actual survival rates were 87.64% +/- 2.02%, 83.35% +/- 2.38% and 68.19% +/- 5.63%, respectively. Thromboembolism was observed in 38 patients (13.77%). The rates of actual freedom from thromboembolism in the 5, 10 and 15-year periods were 93.08% +/- 1.53%, 88.48% +/- 1.99% and 81.06% +/- 3.43%, respectively. Of the 276 patients who had been observed for 15 years, 5 had (1.81%) valvular thrombosis. The rates of actual freedom from valvular thrombosis in the 5, 10 and 15-year periods were 98.89% +/- 0.64%, 98.04% +/- 0.87% and 98.04% +/- 0.87%, respectively. In the 15-year period, 23 patients (8.33%) had haemorrhage due to anti-coagulation. The rates of actual freedom from haemorrhage due to anti-coagulation in the 5, 10 and 15-year periods were 95.64% +/- 1.23%, 93.40% +/- 1.56% and 87.73% +/- 2.96%, respectively. Seven patients (2.54%) had prosthetic valvular endocarditis. The rates of actual freedom from endocarditis in the 5, 10 and 15-year periods were 98.51% +/- 0.74%, 97.60% +/- 0.97% and 97.01% +/- 1.13%, respectively. Nine patients (3.27%) were re-operated. The rates of actual freedom from re-operation in the 5, 10 and 15-year periods were 97

Transcatheter Pulmonary Valve Replacement by Hybrid Approach Using a Novel Polymeric Prosthetic Heart Valve: Proof of Concept in Sheep

PubMed Central

Xu, Tong-yi; Zhang, Zhi-gang; Li, Xin; Han, Lin; Xu, Zhi-yun

2014-01-01

Background Since 2000, transcatheter pulmonary valve replacement has steadily advanced. However, the available prosthetic valves are restricted to bioprosthesis which have defects like poor durability. Polymeric heart valve is thought as a promising alternative to bioprosthesis. In this study, we introduced a novel polymeric transcatheter pulmonary valve and evaluated its feasibility and safety in sheep by a hybrid approach. Methods We designed a novel polymeric trileaflet transcatheter pulmonary valve with a balloon-expandable stent, and the valve leaflets were made of 0.1-mm expanded polytetrafluoroethylene (ePTFE) coated with phosphorylcholine. We chose glutaraldehyde-treated bovine pericardium valves as control. Pulmonary valve stents were implanted in situ by a hybrid transapical approach in 10 healthy sheep (8 for polymeric valve and 2 for bovine pericardium valve), weighing an average of 22.5±2.0 kg. Angiography and cardiac catheter examination were performed after implantation to assess immediate valvular functionality. After 4-week follow-up, angiography, echocardiography, computed tomography, and cardiac catheter examination were used to assess early valvular function. One randomly selected sheep with polymeric valve was euthanized and the explanted valved stent was analyzed macroscopically and microscopically. Findings Implantation was successful in 9 sheep. Angiography at implantation showed all 9 prosthetic valves demonstrated orthotopic position and normal functionality. All 9 sheep survived at 4-week follow-up. Four-week follow-up revealed no evidence of valve stent dislocation or deformation and normal valvular and cardiac functionality. The cardiac catheter examination showed the peak-peak transvalvular pressure gradient of the polymeric valves was 11.9±5.0 mmHg, while that of two bovine pericardium valves were 11 and 17 mmHg. Gross morphology demonstrated good opening and closure characteristics. No thrombus or calcification was seen

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.

Emergency aortic valve replacement and Caesarian section in a primigravida with severe aortic stenosis: a case report.

PubMed

Kochhar, Puneet K; Zutshi, V; Shamsunder, S; Batra, S; Ghosh, P

2011-01-01

Congenital bicuspid aortic valve with severe aortic stenosis (AS) is a rare condition (3-6% of patients with congenital heart disease). Pregnancy in these patients carries a high risk of maternal and fetal mortality. With advancing gestational age, these women may develop cardiac failure due to increased cardiorespiratory requirements. When medical therapy proves insufficient, cardiac surgery becomes mandatory to save the patient's life. Balloon valvuloplasty is only palliative treatment, the duration of benefit being only 6 months. Valve replacement is thus recommended. Cardiopulmonary bypass (CPB) surgery with valve replacement has been reported to carry a lower risk of maternal mortality (1.5-13%) but a very high fetal risk (16-40%). This paper reports the case of a 30-year-old primigravida with severe AS with bicuspid aortic valve and pulmonary congestion clinically uncontrolled, in whom CPB surgery and aortic valve replacement was performed as an emergency procedure, along with a lower segment Caesarian section. The outcome of unrelieved severe symptomatic AS in pregnancy is poor. Multidisciplinary management is important to avoid deterioration in cardiac performance in parturients with severe AS. CPB during pregnancy carries a high risk to the fetus. Therefore, open heart surgery during pregnancy should be advised only in extreme emergencies (ie, heart failure refractory to conventional therapy).

A 20-year study on treating childhood infective endocarditis with valve replacement in a single cardiac center in China.

PubMed

Xiao, Jian; Yin, Liang; Lin, Yiyun; Zhang, Yufeng; Wu, Lihui; Wang, Zhinong

2016-07-01

Children with infective endocarditis (IE) have to undergo valve replacement instead of valve repair in China due to severe valve damage. The present study is to review our experience on surgical treatment of children with IE in reference to the incidence, pathologic status, diagnosis, surgical strategies and outcomes. We reviewed 35 patients with a mean age of 13.7±2.2 years who were underwent valve replacement surgery for IE during the period from January 1993 to December 2013. Preoperative transthoracic echocardiographic (TTE) evaluation and transesophageal echocardiography during operation were performed in all patients. All the children underwent chart review and retrospective risk-hazard analysis. Among the patients surveyed congenital cardiac lesions were present in 15 (42.8%), rheumatic heart valve disease in 2 (5.7%) and previous heart surgery in 2 (5.7%). The median stay of intensive care unit was 6 days. Intraoperative findings showed that the endocarditis involved mostly the mitral and aortic valves (88.5%). Triple or quadruple valve involvement was found in one patient each. Ten-year freedom from IE-related death and re-intervention was 94.2% and 91.6%, respectively. Children undergoing surgery for IE frequently have advanced disease with embolic complications. Although valve replacement is not the primary option for pediatric IE, the rate of 5-year survival and freedom from re-operation was optimal prognostically. Pediatric physicians should pay attention to the common clinical features of IE so that the native valve is preserved well.

Acute gastrointestinal bleeding following aortic valve replacement in a patient with Heyde's sindrome. Case report.

PubMed

De Palma, G D; Salvatori, F; Masone, S; Simeoli, I; Rega, M; Celiento, M; Persico, G

2007-09-01

A 58-year old man was admitted to the hospital because of melena. He had a 1-year history of mechanical aortic valve replacement and coronary stent placement because of myocardial infarction and he was taking warfarin and clopidogrel. Esophagogastroduodenoscopy and colonoscopy were negative for bleeding. Capsule endoscopy showed bleeding diffuse angiodysplasia of the small bowel. The patient was treated with octreotide 20 mg, at monthly interval. After 25 months there had been no recurrence of gastrointestinal bleeding. The case suggests that mechanical valve replacement may not prevent gastrointestinal bleeding in Heyde syndrome and that octreotide treatment should be considered in these cases.

Double-arterial cannulation for aortic valve replacement with porcelain aorta.

PubMed

De Paulis, Ruggero; Maselli, Daniele; Scaffa, Raffaele; Nardella, Saverio

2009-10-01

We describe a new technique of aortic valve replacement (AVR) in patients with porcelain aorta. Three patients (mean age 75 years) were treated. The cardiopulmonary bypass (CPB) was established after side-graft right axillary artery and direct femoral artery cannulation. Venous drainage was obtained by atrio-caval cannulation. The procedures were performed in mild hypothermia (30 degrees C). Cerebral perfusion was carried out by clamping the innominate artery and all epiaortic vessels. The aorta was endoclamped by a Foley balloon inserted into the isthmus. The aorta was then opened longitudinally for 10 cm to expose and replace the aortic valve. Near-infra-red spectroscopy (NIRS) and bilateral radial artery pressure were used to monitor effective cerebral perfusion. Operative mortality was absent. The mean time of CPB was 73 min. NIRS-derived tissue oxygenation was maintained above 55%. Postoperative course was uneventful. This technique has several advantages: first, the cannulation of right axillary and the common femoral artery allows simultaneous cerebral and systemic perfusion. Second, any form of cross-clamp is avoided and the aorta is occluded away from the epiaortic vessels. Third, there is an increased freedom to choose the best place for aortotomy.

Novel valve replacement with an extracellular matrix scaffold in an infant with single ventricle physiology.

PubMed

Guariento, Alvise; Burke, Redmond; Fedrigo, Marny; Angelini, Annalisa; Maschietto, Nicola; Vida, Vladimiro; Thiene, Gaetano; Stellin, Giovanni; Padalino, Massimo

2016-01-01

Valve replacement in children with functionally univentricular hearts remains challenging. The absence of small prostheses, the lack of growth, and the need for anticoagulation limit these procedures. We describe a 1-year follow-up of an extracellular matrix scaffold tube used as systemic atrio-ventricular valve in an infant. Copyright © 2015 Elsevier Inc. All rights reserved.

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. © 2016 American Heart Association, Inc.

Outcomes of Treatment of Nonagenarians With Severe Aortic Stenosis.

PubMed

Mack, Molly Claire; Szerlip, Molly; Herbert, Morley A; Akram, Siddique; Worley, Christina; Kim, Rebeca J; Prince, Brandon A; Harrington, Katherine B; Mack, Michael J; Holper, Elizabeth M

2015-07-01

Because nonagenarians with aortic stenosis (AS) often present as frail with more comorbid conditions, long-term outcomes and quality of life are important treatment considerations. The aim of this report is to describe survival and functional outcomes of nonagenarians undergoing treatment for AS by surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). This is a retrospective analysis of all patients aged 90 years or more undergoing treatment for AS between 2007 and 2013 at two centers. Outcomes were compared between SAVR and TAVR. Long-term survival was compared with an age- and sex-matched population from the Social Security Actuarial Life Table. In all, 110 patients underwent treatment for isolated AS (20 SAVR and 90 TAVR). Mean age was 91.85 ± 1.80 years, and 50.9% were female. The Society of Thoracic Surgeons mean predicted risk of mortality was 11.11% ± 5.74%. Operative mortality was 10.9% (10.0% SAVR; 11.1% TAVR); 2.7% of patients had a stroke. The TAVR patients were more likely to be discharged home (75.9% versus 55.6% for SAVR, p = 0.032). Mean follow-up was 1.8 ± 1.5 years, with a 1-year and 5-year survival of 78.7% and 45.3%, respectively, which approximated the US actuarial survival. There was a significant improvement in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire at 1 year compared with baseline. Treatment of AS approximates natural life expectancy in select nonagenarians, with no significant difference in long-term survival between SAVR and TAVR. Importantly, patient quality of life improved at 1 year. With appropriate selection, nonagenarians with severe AS can benefit from treatment. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Multicenter Analysis of Clinical Follow-Ups in Patients with a Star GK Cardiac Valve Replacement for More than One Year.

PubMed

Li, Mingwen; Xiao, Yingbin; Chen, Daozhong; Liu, Liming; Ma, Liming; Wang, Pingfan; Jia, Kui; Yang, Kai; Chen, Lin

2016-05-18

Star GK valves were widely used in China, and we studied the clinical follow-up results of patients with Star GK valve implants for more than one year.  Clinical data were collected from those patients who had Star GK valve implants for over one year. Patients were divided into three groups: (1) AVR group: received aortic valve replacement surgery. Based on the valve model this group was further sub-divided into two groups: 21A group, and 23A group; (2) MVR group: received mitral valve replacement surgery. Based on the valve model this group was further sub-divided into three groups: 25M group, 27M group, and 29M group; (3) DVR group: received combined replacement surgeries including AVR + MVR. According to postoperative follow-up time these patients were divided into two groups: 1-year group and 3-year group. Follow-up data were collected by telephone, outpatient visits, or correspondence. Clinical data were aggregated by professional data scientists to conduct independent analyses.  959 patients were included in the study following Star GK valve implant. Follow-up after 1 year found that thrombosis occurred in 4 cases, hemorrhage in 15 cases, left heart failure in 13 cases, paravalvular leakage in 5 cases, and death due to cardiac causes in 2 cases.  The long-term efficacy of Star GK valve implants was satisfactory with low incidence of valve-related complications, and following Star GK valve implant, valve and blood were highly compatible and blood component damage was minor. Very low incidence rate of thrombosis was observed following Star GK valve implant, however, attention should be paid to adjust the anticoagulation intensity.

[Experience of Mitral Valve Replacement Using a Pulmonary Autograft (Ross II Operation) in an Infant;Report of a Case].