Transcatheter Heart Valve Durability Research Articles

Ten-year Durability, Hemodynamic Performance, and Clinical Outcomes after Transcatheter Aortic Valve Implantation Using a Self-expanding Device.

The expansion of transcatheter aortic valve implantation (TAVI) to low-risk and younger patients has increased the relevance of the long-term durability of transcatheter heart valves (THV). The present study aims to assess the 10-year durability, hemodynamic performance, and clinical outcomes after TAVI using the CoreValve system. An analysis from a prospective registry with predefined clinical and echocardiographic follow-up included 302 patients who underwent TAVI with the CoreValve system between 2007 and 2015. Bioprosthetic valve failure (BVF) was defined as any bioprosthetic valve dysfunction-related death, re-intervention, or severe hemodynamic valve deterioration. At the time of TAVI, the mean age was 80.41 ± 7.01years, and the Society of Thoracic Surgeons (STS) score was 6.13 ± 5.23%. At latest follow-up (median [IQR]: 5 [2-7] years), cumulative all-cause mortality ratesat 3, 5, 7, and 10years was 23.7%, 40%, 65.8%, and 89.8%, respectively. Mean aortic valve area and transvalvular gradient post-TAVI and at 5, 7, and 10years were 1.94, 1.87, 1.69, and 1.98 cm2 (p = 0.236) and 8.3, 9.0, 8.2, and 10.1mmHg (p = 0.796), respectively. Overall, 11 patients had BVF, of whom six had structural valve deterioration (SVD). The 10-year actual and actuarial freedom from BVF was 96.1% and 78.8%, and from SVD was 97.9% and 80.9%, respectively. Three patients developed significant non-SVD due to severe paravalvular leakage, and two patients were diagnosed with infective endocarditis. Using an early-generation self-expanding bioprosthesis, we documented durable hemodynamic performance and low rates of BVF and SVD up to 10 years after TAVI.

Valve-in-Valve Transcatheter Aortic Valve Replacement: From Pre-Procedural Planning to Procedural Scenarios and Possible Complications.

Over the last decades, bioprosthetic heart valves (BHV) have been increasingly implanted instead of mechanical valves in patients undergoing surgical aortic valve replacement (SAVR). Structural valve deterioration (SVD) is a common issue at follow-up and can justify the need for a reintervention. In the evolving landscape of interventional cardiology, valve-in-valve transcatheter aortic valve replacement (ViV TAVR) has emerged as a remarkable innovation to address the complex challenges of patients previously treated with SAVR and has rapidly gained prominence as a feasible technique especially in patients at high surgical risk. On the other hand, the expanding indications for TAVR in progressively younger patients with severe aortic stenosis pose the crucial question on the long-term durability of transcatheter heart valves (THVs), as patients might outlive the bioprosthetic valve. In this review, we provide an overview on the role of ViV TAVR for failed surgical and transcatheter BHVs, with a specific focus on current clinical evidence, pre-procedural planning, procedural techniques, and possible complications. The combination of integrated Heart Team discussion with interventional growth curve makes it possible to achieve best ViV TAVR results and avoid complications or put oneself ahead of time from them.

Long-term Outcomes of Transcatheter Aortic Valve Replacement With the Lotus Valve vs CoreValve/EvolutR

Long-term follow-up after transcatheter aortic valve replacement (TAVR) is of interest given that longitudinal data on mortality and durability of transcatheter heart valves are limited. The REPRISE III (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Randomized Clinical Evaluation) randomized clinical trial compared the mechanically expanded Lotus valve with the self-expanding CoreValve/EvolutR TAVR platforms. To describe the final 5-year outcomes of the REPRISE III trial. This prespecified secondary analysis assessed the final 5-year clinical, functional, and echocardiographic outcomes of 912 patients from the REPRISE III trial, which was conducted at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015. Patients had high risk for aortic stenosis or severe or symptomatic aortic stenosis. Data were analyzed from September 22, 2014, to May 21, 2021. Lotus valve or CoreValve/EvolutR TAVR platforms. Valve Academic Research Consortium-2 end points, hemodynamic measures, functional status, and health status were examined through the 5-year follow-up. A total of 912 patients (mean [SD] age, 82.8 [7.3] years; 463 women [50.8%]) were randomized to either the Lotus valve group (n = 607) or CoreValve/EvolutR group (n = 305), with a baseline Society of Thoracic Surgeons risk score of 6.8%. Clinical follow-up data from the REPRISE III trial were available for 581 patients (95.7%) in the Lotus valve group and 285 patients (93.4%) in the CoreValve/EvolutR group. At 5 years, the cumulative event rate for all-cause mortality was 50.9% in the Lotus valve group vs 52.8% in the CoreValve/EvolutR group (P = .59). Disabling stroke was less frequent with the Lotus valve vs CoreValve/EvolutR (cumulative event rates, 8.3% vs 12.2%; P = .04), whereas the cumulative event rates for overall stroke were similar in both groups (14.1% vs 15.3%; P = .38). Insertion of a new permanent pacemaker (38.9% vs 27.3%; P < .001) and detection of prosthetic aortic valve thrombosis (5.8% vs 1.8%; P = .007) were more common in the Lotus valve group than in the CoreValve/EvolutR group. A smaller proportion of patients who received the Lotus valve experienced valve malpositioning (0% vs 2.6%; P < .001) and required the use of a second valve (1.0% vs 3.8%; P < .001) during the procedure compared with those who received the CoreValve/EvolutR. Compared with the Lotus valve group, the CoreValve/EvolutR group had a significantly lower mean (SD) aortic gradient (7.8 [4.2] mm Hg vs 12.6 [6.7] mm Hg; P < .001) and larger valve areas (1.57 [0.56] cm2 vs 1.42 [0.42] cm2; P = .10). After 5 years, the proportion of patients with moderate or greater paravalvular leak was not significantly higher with the CoreValve/EvolutR than with the Lotus valve (1.9% vs 0%; P = .31); however, the proportion of patients with mild paravalvular leak was higher in the CoreValve/EvolutR group compared with the Lotus valve group (23.1% vs 7.8%; P = .006). Long-term, similar improvements in New York Heart Association class and Kansas City Cardiomyopathy Questionnaire score were observed in both groups. The REPRISE III trial found that, at 5 years, the clinical outcomes of the Lotus valve were comparable to those of the CoreValve/EvolutR and that the Lotus valve was safe and effective. ClinicalTrials.gov Identifier: NCT02202434.

The 10-year horizon: Survival and structural valve degeneration in first-generation transcatheter aortic valves

Transcatheter aortic valve replacement is an established treatment for high- or intermediate-risk patients with symptomatic aortic valve stenosis. As more low-risk patients are being treated, transcatheter heart valve durability is gaining importance. Data on structural valve deterioration beyond 8 years after transcatheter aortic valve replacement is limited. To evaluate the outcomes of transcatheter aortic valve replacement in high-risk patients with a follow-up of ≥10 years, focusing on survival and structural valve deterioration, according to the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery definitions. Only patients with a follow-up of ≥ 10 years were included in this study (n=510). Using serial echocardiographic data, the cumulative incidences of structural valve deterioration and bioprosthetic valve failure were analysed. Receiver operating characteristic analysis was used for predictor assessment. Mean age was 79.6±6.7 years, with a mean logistic EuroSCORE of 19.8±12.7%. Immediate procedural mortality was 2.9%, and 30-day mortality was 7.8%. Kaplan-Meier-estimated survival at 10 years was 10.3±1.5%. At 10 years, the cumulative incidences of severe and moderate structural valve deterioration were 4.3% and 13%, respectively, for the total population. The cumulative incidence of bioprosthetic valve failure at 10 years was 9.0%. There was a significant difference in the rates of structural valve deterioration and bioprosthetic valve failure depending on valve type: structural valve deterioration, SAPIEN 8.9% vs CoreValve 2.2% at 10 years (P=0.001); bioprosthetic valve failure, SAPIEN 13.9% vs CoreValve 6.7% at 10 years (P=0.021). Structural valve deterioration and bioprosthetic valve failure of early transcatheter heart valves was low at 10 years. The identified differences between valve types must be validated using current-generation devices in younger patients.

Abstract 10041: Long Term Durability of Transcatheter Bioprosthetic Aortic Valves

Introduction: Transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement in patients with severe aortic stenosis. However, data on long-term durability of bioprosthetic valve dysfunction (BVD) remain not enough. Therefore, we investigated the durability of transcatheter heart valve (THV) using new standardized criteria in patients at 5-year after TAVI. Hypothesis and Methods: From January 2012 to September 2015, among 114 patients with severe aortic stenosis, 28 and 86 patients underwent TAVI with self-expandable Medtronic CoreValve and balloon-expandable Edwards SAPIEN-XT, respectively.BVD was defined as Valve Academic Research Consortium 3 (VARC-3) criteria. Moderate/ severe hemodynamic valve deterioration (HVD) was defined as increase in mean transvalvular gradient &amp;gt; 10 mmHg/ &amp;gt; 20 mmHg resulting in mean gradient &amp;gt; 20 mmHg/ &amp;gt; 30 mmHg with concomitant decrease in effective orifice area (EOA) &amp;lt; 0.3 cm 2 / &amp;lt; 0.6 cm 2 or new occurrence or increase of &amp;gt; 1 grade/ &amp;gt; 2 grade of intra-prosthetic aortic regurgitation (AR) resulting in moderate/ severe AR. Bioprosthetic valve failure (BVF) was defined as valve related death, aortic valve reintervention, any bioprosthetic valve dysfunction associated with clinically expressive criteria or severe hemodynamic HVD. Results: During 5-year follow-up period, all-cause mortality was 43.8% (50 patients). There was 1 patient with severe BVD due to severe aortic regurgitation after CoreValve implantation. Four patients (3.5%) showed moderate BVD, which resulted in increased mean THV gradient, and all of whom received SAPIEN-XT implantation. BVF occurred in 2 patients (1.8%) during 5 years after CoreValve and SAPIEN-XT implantation. Follow-up echocardiography at 5 year were conducted in 48 patients (42.1%). The mean pressure gradient was 7.7 ± 3.8 mmHg and 11.9 ± 4.9 mmHg in patients with CoreValve and SAPIEN-XT, respectively (p=0.012). Conclusions: This study was evaluated THV durability using the VARC-3 definition. The incidence of BVD were uncommon during long-term follow-up period. Furthermore, the 5-years’ THV performance of early generation balloon-expandable and self-expandable device were maintained after TAVI.

Percutaneous bioprosthetic aortic valve durability: results a single center after ten years of follow-up ago

Abstract The durability of transcatheter heart valves and long-term clinical outcomes are unknown. The aim of this study was to evaluate clinical and hemodynamic outcomes 10 years after Transcatheter Aortic Valve Implantation (TAVI). Methods Between April 2008 and December 2011, 230 patients underwent TAVI for the treatment of severe symptomatic aortic stenosis with the auto-expandable prosthesis. Results The mean age, logistic EuroSCORE and STS score were 79.3±6.4 years, 19.8±13% and 6.8±5% respectively. Mean aortic valve gradient decreased from 49.8±15 mm Hg to 8.6±3.8 mmHg after TAVI, to 11.1±9 mm Hg at 5 years, and 25.7±12 mmHg at 7 years (p for post-TAVI trend 0.03). Mean aortic valve area increased from 0.63±0.16 cm2 to 1.57±0.3cm2 after TAVI to 1.48±0.2 at 5 years and 0.87±0.3 cm2 at 7 years (p for post-TAVI trend 0.01). Mean left ventricular ejection fraction increased from 61.1±15% to 65.5±11% after TAVI, to 58.2±17% at 5 years and 57.2±8% at 7 years (p for post-TAVI trend 0.001). The total mortality after a mean of 53±34 months was 73% and 34.4% was cardiovascular mortality. Survival rates at 1 to 10 years were at 86%, 75.4%, 64.9%, 59.6%, 52.6%, 33.1%, 24.9%, 20.7%, 10.4% and 10.4% respectively. Only 4 patients had severe prosthetic valve dysfunction (severe stenosis and moderate-severe transvalvular regurgitation). Median survival time after TAVI was 6 years (95% confidence interval [CI]: 5.89 to 6.28), and the risk of death was significantly increased in patients with frailty (adjusted hazard ratio [HR]: 1.874; 95% CI: 1.028 to 3.418), p=0.040, Charlson index [HR=1.212 (95% CI: 1.094–1.341), p&amp;lt;0.001], and age [HR=1.03; (95% CI: 1.001–1.062), p=0.049]. Conclusions In our center, the transcatheter aortic valve implantation in patients at high surgical risk, presented favourable clinical outcomes and hemodynamic performance after ten years of follow-up. Funding Acknowledgement Type of funding sources: None.

Long-term durability of transcatheter aortic valve replacement: outcomes from a contemporary cohort from a tertiary reference center at 5-years and beyond

Abstract Background and aim Long-term data on the durability of transcatheter heart valves is scarce. This is of particular interest as indications expand to younger and lower surgical risk patients. We sought to assess the incidence of long-term structural valve dysfunction (SVD) and bioprosthetic valve failure (BVF) in a cohort of patients with TAVR who reached at least 5-year follow-up, as compared to surgical aortic valve replacement (SAVR), performed within the same time-frame at the same institution. Methods and results Consecutive patients with at least 5-year available follow-up, who underwent TAVR between November 2008 to December 2015 in a tertiary single center, were included. From a group of 246 patients undergoing TAVR, 126 had available follow-up data (age at implantation: 83.0 [77.8–87.0] years; EuroScore II: 4.54 [2.60–6.29]%; follow-up: 5.94 [5.06–7.67] years). First generation Corevalve® and Sapien® prosthesis were implanted in 56% and 38% patients, respectively. SVD and BVF were defined according to the new consensus statement from the EAPCI endorsed by the ESC and the EACTS. Mean transaortic pressure gradients decreased from 53.2±1.3 mmHg (pre-TAVR) to 10.4±0.4 mmHg (at discharge or up to one-year after TAVR, p&amp;lt;0.001), and there was a small non-significant increase at the fifth-year and the last available follow-up (11.2±0.6 mmHg; 14.7±1.8 mmHg, respectively). Moderate and severe SVD were reported in 12 and 4 patients, respectively (8-year cumulative incidence function to SVD: 2.67%; 95% CI, 2.12–3.89). Of these 8 had BVF, 7 of them with hospitalization for acute heart failure. A total of 4 patients died and none required reintervention (redo TAVR or SAVR). BVF for non-SVD were observed in 4 patients (2 subclinic thrombosis successfully treated with anticoagulation and 2 paravalvular regurgitation due to endocarditis). As comparator, from a cohort of 587 patients submitted to biological SAVR, 247 (age 75.0 [70.0–79.0] years; EuroScore II 1.43 [1.06–2.17]%) had available long-term follow-up (6.89 [6.08–8.19] years). Moderate and severe SVD were reported in 42 and 3 patients, respectively (8-year cumulative incidence function to SVD: 3.13%; 95% CI, 2.45–4.21). These events were clinically relevant (BVF) in 19 of them: 8 performed TAVR valve-in-valve procedures and 3 redo SAVR. At the fifth-year of follow-up the incidence of SVD was not statistically different between TAVR (8%) and SAVR (15%), with a p for comparison of 0.137. Conclusions In our population of patients with symptomatic severe aortic stenosis treated with first-generation percutaneous bioprostheses, TAVR was associated with a low incidence of BVF and SVD at the long-term follow-up. These outcomes seem indistinct from those occurring in patients submitted to conventional SAVR Funding Acknowledgement Type of funding sources: None. KM curve reporting probability of SVD

Durability of Transcatheter Heart Valves: Standardized Definitions and Available Data.

Transcatheter aortic valve replacement is a well-established alternative to surgical aortic valve replacement in high-risk patients with severe symptomatic aortic stenosis. Currently, this technique is shifting towards younger patient groups with intermediate- and low-risk profile, which raises the question about long-term durability. Despite acceptable results up to 5 years, little is currently known about valve performance beyond 5 years. Since valve deterioration, thrombosis and endocarditis seem to be the main factors affecting valve durability, precise and widely accepted definitions of these parameters were stated by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) in 2017, followed by the Valve in Valve International Data (VIVID) group definitions in 2018 and the Valve Academic Research Consortium 3 (VARC-3) definitions in 2021. Until the introduction of these definitions, interstudy comparisons were difficult due to missing uniformity. Since the release of these recommendations, an increasing number of studies have reported their data on long-term durability using these new criteria. The aim of the present article is to discuss the current definitions on bioprosthetic valve durability, and to summarize the available data on long-term durability of transcatheter aortic valves.

Transcatheter Versus Surgical Aortic Valve Replacement in Young, Low-Risk Patients With Severe Aortic Stenosis.

Transcatheter aortic valve replacement (TAVR) is approved for all patient risk profiles and is an option for all patients irrespective of age. However, patients enrolled in the low- and intermediate-risk trials were in their 70s, and those in the high-risk trials were in their 80s. TAVR has never been systematically tested in young (<65 years), low-risk patients. Unanswered questions remain, including the safety and effectiveness of TAVR in patients with bicuspid aortic valves; future coronary access; durability of transcatheter heart valves; technical considerations for surgical transcatheter heart valve explantation; management of concomitant conditions such as aortopathy, mitral valve disease, and coronary artery disease; and the safety and feasibility of future TAVR-in-TAVR. The authors predict that balancing these questions with patients' clear preference for less invasive treatment will become common. In this paper, the authors consider each of these questions and discuss risks and benefits of theoretical treatment strategies in the lifetime management of young patients with severe aortic stenosis.

Long-term Follow-up After Transcatheter Aortic Valve Replacement

BackgroundTranscatheter aortic valve replacement (TAVR) has become the standard of care in the majority of patients with symptomatic severe aortic stenosis. Data on long-term mortality and durability of transcatheter heart valves (THVs) beyond 5 years are limited. Our study aimed to assess elderly and high-risk patients’ long-term outcomes treated with TAVR in a prospective single-centre registry focusing on the durability of THVs. MethodsWe included 795 patients with severe calcific aortic stenosis treated by transfemoral TAVR between 2006 and 2011. Echocardiography was performed at baseline; discharge; 1 year; and afterward, annually, until the longest available follow-up. Mortality rates were estimated for 1, 5, 6, 7, and 8 years. The rates of structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) were assessed in accordance with consensus definitions. Outcome measures were adjudicated according to Valve Academic Research Consortium-2 (VARC-2). ResultsMedian (interquartile range) follow-up time was 1345 (316; 2015) days. One-year, 5-year, 6-year, 7-year, and 8-year overall mortality was 25.4%, 59.0%, 64.6%, 67.9%, and 69.2%, respectively. At 8 years, no significant differences in mortality were found comparing self-expanding vs balloon-expandable valves (69.5% vs 68.0%, P = 0.709) and postdilatation (PD) vs no-PD (69.4% vs 69.2%, P = 0.363). SVD was detected in 26 patients (3.3%), and 19 (2.4%) of the 795 patients had evidence of BVF during follow-up. ConclusionsOur study demonstrates good long-term results for high-risk patients who were alive up to 8 years after TAVR.

Reintervention with Transcatheter and Surgical Aortic Valves: A Systematic Review and Meta-Analysis

Background: Despite expanding indications, data regarding the long-term durability of transcatheter heart valves (THV) are limited. Methods: We performed a systematic review and meta-analysis of all published studies with ≥5years of follow-up reporting aortic valve reintervention rates of transcatheter (TAVR) and surgical aortic valve replacement (SAVR). Randomized controlled trials (n = 4) and propensity-matched observational studies (n = 1) involving all surgical risk categories were included. The primary endpoint was the composite of aortic valve reintervention and death. Results: The meta- analysis included 4145 patients: 2101 underwent TAVR (mean age 81.7 ± 6.7 years, 54% male) and 2044 SAVR (mean age 81.8 ± 6.6 years, 54% male). All TAVR procedures were performed with early generations of THV. At a median follow-up of 5 years (range 5 - 6 years), TAVR had higher reintervention rates (odds ratio (OR) 3.33; 95% CI: [1.78, 6.24], p 2 = 0%), all-cause mortality (OR 1.45; 95% CI: [1.22, 1.75], p 2 = 44%) and the composite of reintervention and death (OR 1.47; 95% CI: [1.14, 1.91], p 2 = 64%). Rates of myocardial infarction, transient ischemic attack, stroke, endocarditis, and the composite of endocarditis and thrombosis were similar between the groups. Conclusion: Despite comparable short and medium-term results, TAVR with early-generation THV has higher rates of reintervention and the composite of reintervention and death. Further studies employing newer definitions of structural valve deterioration and bioprosthetic valve failure are needed to assess whether technological enhancements in THV technology will improve long-term outcomes.

5-Year Outcomes After TAVR With Balloon-Expandable Versus Self-Expanding Valves: Results From the CHOICE Randomized Clinical Trial

ObjectivesThe purpose of this study was to evaluate clinical and echocardiographic outcome data of the CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients with Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT) trial at 5 years. BackgroundThe CHOICE trial was designed to compare device performance of a balloon-expandable (BE) transcatheter heart valve (THV) versus a self-expanding (SE) THV. MethodsThe CHOICE trial is an investigator-initiated trial that randomized 241 high-risk patients with severe symptomatic aortic stenosis and an anatomy suitable for treatment with both BE and SE THVs to transfemoral transcatheter aortic valve replacement with either device. The primary endpoint was device success. Patients were followed up to 5 years, with assessment of clinical outcomes, and echocardiographic evaluation of valve function and THV durability. ResultsAfter 5 years, there were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (53.4% vs. 47.6%; p = 0.38), death from cardiovascular causes (31.6% vs. 21.5%; p = 0.12), all strokes (17.5% vs. 16.5%; p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%; p = 0.75). SE patients had larger prosthetic valve area (1.6 ± 0.5 cm2 vs. 1.9 ± 0.5 cm2; p = 0.02) with a lower mean transprosthetic gradient (12.2 ± 8.7 mm Hg vs. 6.9 ± 2.7 mm Hg; p = 0.001) at 5 years. No differences were observed in the rates of paravalvular regurgitation. Clinical valve thrombosis occurred in 7 BE patients (7.3%) and 1 SE patient (0.8%; p = 0.06), and moderate or severe structural valve deterioration in 6 BE patients (6.6%) and no SE patient (0%; p = 0.018). The rate of bioprosthetic valve failure was low and not significantly different between both groups (4.1% vs. 3.4%; p = 0.63). ConclusionsFive-year follow-up of patients in the CHOICE trial revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with early-generation BE and SE valves that were not statistically significantly different, with limited statistical power. Forward flow hemodynamics were significantly better with the SE valve. Moderate or severe structural valve deterioration was uncommon but occurred more frequently with the BE valve. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial [CHOICE]; NCT01645202)

Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction

BackgroundTranscatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail. ObjectivesThe authors sought to examine outcomes following redo-TAVR. MethodsThe Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively. ResultsAmong 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis–regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm2 and 1.51 ± 0.57 cm2; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively. ConclusionsRedo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.

Transcatheter Aortic Valve Replacement: Procedure and Outcomes.

Initially, transcatheter aortic valve replacement (TAVR) was only used in patients with severe symptomatic aortic stenosis and prohibitive risk for surgical aortic valve replacement. Subsequently, TAVR was extended to patients with high and intermediate surgical risk. Recently, the results of randomized trials in low-surgical-risk patients showed superiority or noninferiority of TAVR versus surgical aortic valve replacement in this population. Procedural outcomes have been improved. Long-term durability of transcatheter heart valves remains to be confirmed. This article presents the evolution and current status of TAVR, with respect to the different types of devices and procedures as well as its outcomes.

A geometry optimization framework for transcatheter heart valve leaflet design

Transcatheter aortic valve replacement (TAVR) is an established treatment for patients with severe symptomatic aortic stenosis. It is known and recognized that leaflet geometry has a key role in structural and hemodynamic performance of bioprosthetic heart valves. Excessive mechanical stress on the leaflets will lead to accelerated tissue degeneration and diminished long-term valve durability. The goal of this study was to develop an automatic optimization framework by means of commercially available software packages to reduce maximum stress value of transcatheter aortic valve (TAV) leaflets. Leaflet design was parameterized by 2 s-order non-uniform rational B-splines (NURBS) curves and particle swarm optimization method was used to examine the optimization design space. Optimized leaflet geometry for 23-mm and 26-mm TAVs were obtained under dynamic physiological loading condition. Leaflet stress distributions of the optimized TAV geometries were compared with two commercially available bioprostheses (i) Carpentier-Edwards PERIMOUNT Magna surgical bioprosthesis and (ii) Edwards SAPIEN 3 transcatheter heart valve. A considerable reduction in the maximum in-plane principal stress was observed in the optimized TAV geometries compared to the commercially available bioprostheses. The optimization results underline the opportunity to improve leaflet design in the next generation of TAVs to potentially increase long-term durability of transcatheter heart valves.

P3698Long-term durability of transcatheter aortic valve prostheses: results of a center

Abstract The durability of transcatheter heart valves and long-term clinical outcomes are unknown. The aim of this study was to evaluate clinical and hemodynamic outcomes between 5 to 9 years after Transcatheter Aortic Valve Implantation (TAVI). Methods Between April 2008 and December 2012, 305 patients underwent TAVI for the treatment of severe symptomatic aortic stenosis with the auto-expandable prosthesis. Results The mean age, logistic EuroSCORE and STS score were 79.3±6.5 years, 19.4±12% and 6.6±4% respectively. Mean aortic valve gradient decreased from 48.7±15 mm Hg to 8.9±4.3 mmHg after TAVI, to 11.1±9 mm Hg at 4 years, and 22.7±12 mmHg at 5 years (p for post-TAVI trend 0.03). Mean aortic valve area increased from 0.63±0.16 cm2 to 1.57±0.3cm2 after TAVI to 1.48±0.2 at 4 years and 0.97±0.3 cm2 at 5 years (p for post-TAVI trend 0.01). Mean left ventricular ejection fraction increased from 61.1±15% to 65.5±11% after TAVI, to 58.2±17% at 4 years and 60.7±8% at 5 years (p for post-TAVI trend 0.001). Late mortality after a mean of 4.15±2.4 years 58% and in only 34.1% patients was cardiovascular mortality. Survival rates at 1 to 9 years were at 87.5%, 79%, 73.1%, 65.6%, 55.4%, 48.2%, 41.9%, 37.3% and 35.1% respectively. At 5 years, 3 patients had severe prosthetic valve dysfunction (severe stenosis and moderate transvalvular regurgitation). Median survival time after TAVI was 6 years (95% confidence interval [CI]: 5.89 to 6.28), and the risk of death was significantly increased in patients with frailty (adjusted hazard ratio [HR]: 1.864; 95% CI: 1.204 to 2.886), p=0.001, Charlson index [HR= 1.243 (95% CI 1.148–1.346), p&lt;0.001], and left ventricular ejection fraction [HR= 1.012; (95% CI 1.001–1.024)p=0.044]. Conclusions Our study demonstrated favorable long-term outcomes after TAVI. Signs of prosthetic valve failure were observed in 0.97% of patients

Long-Term Durability of Transcatheter Heart Valves: Insights From Bench Testing to 25 Years

ObjectivesThis study assessed the long-term durability of nominally deployed transcatheter heart valves (THV) to 1 billion cycles (equivalent to 25 years) and non-nominal (overexpansion, underexpansion, and elliptical) THV deployments to 200 million cycles (equivalent to 5 years) with accelerated wear testing. BackgroundThe long-term durability of THVs is currently unknown. As transcatheter aortic valve replacement expands to lower-risk patients, durability will be of increasing importance. MethodsSAPIEN 3 THVs, sized 20, 23, 26, and 29 mm were assessed. Nominally deployed THVs underwent hydrodynamic performance and mechanical durability as assessed with accelerated wear testing to 1 billion cycles. Magna Ease surgical valves were used as comparators. Durability of non-nominal THV deployments was tested to 200 million cycles. Valves were tested to International Standards Organization 5840:2013 standard. ResultsTHV durability was excellent for both the nominal and non-nominal THV deployments to 1 billion and 200 million cycles, respectively. At 1 billion cycles the regurgitant fraction for the 20-, 23-, 26-, and 29-mm SAPIEN 3 was 0.92 ± 0.47%, 1.29 ± 0.04%, 1.73 ± 0.46%, and 2.47 ± 0.15%, respectively. There was also excellent durability in the comparator Magna Ease valves. The regurgitant fraction of non-nominal overexpanded (20 mm, 4.36 ± 0.53; 23 mm, 7.68 ± 1.39; 26 mm, 6.80 ± 1.17; 29 mm, 9.00 ± 0.37), underexpanded (20 mm, 3.06 ± 0.28; 23 mm, 4.46 ± 0.45; 26 mm, 7.72 ± 0.48; 29 mm, 8.65 ± 2.01), and elliptical (20 mm, 3.30 ± 0.38; 23 mm, 6.13 ± 0.94; 26 mm, 6.77 ± 1.22; 29 mm, 8.72 ± 0.24) THVs were excellent at 200 million cycles. ConclusionsNominal SAPIEN 3 THVs demonstrated excellent durability, to an equivalent of 25-years wear. THV durability was similar to the comparator surgical valves tested. Non-nominal (overexpansion, underexpansion, and elliptical) THV deployments also had excellent durability to an equivalent of 5 years wear.

TCT-736 Long-Term Durability of Transcatheter Heart Valves: Insights From Bench Testing to 25 Years

The long-term durability of transcatheter heart valves (THVs) is currently unknown. As transcatheter aortic valve replacement expands to lower risk patients, durability will be of increasing importance. This study assessed the long-term durability of nominally deployed THVs to 1 billion cycles (

Long-term assessment of durability of transcatheter aortic valves. Experience from the pioneer center

In the context of extension of transcatheter aortic valve implantation (TAVI) indications, transcatheter heart valve durability is a pivotal concern. Being the pioneer center since Fist-In-Man TAVI provides us the longest worldwide follow-up. We aimed to report long-term outcomes and assess valve durability by evaluating structural valve deterioration (SVD) in patients treated with balloon-expandable TAVI prior to 2011. From 2002 to 2011, 242 patients underwent balloon-expandable TAVI in our center. On site clinical and echocardiographic follow-up were scheduled at one month, one year and yearly thereafter. In the absence of universal definition of SVD, we used the surgical definition, survival without reintervention, and proposed a definition using echocardiographic criteria. SVD was considered moderate when mean aortic gradient was ≥ 20 mmHg and < 40 mmHg and/or aortic central regurgitation was moderate, and severe when mean aortic gradient was ≥ 40 mmg and/or aortic central regurgitation was severe. SVD was defined as definite, probable, or possible. Mean age was 82.2 years. Patients were highly symptomatic (79.1% in NYHA III/IV), mean logistic Euroscore was 25.5 ± 14.2%. 30-day mortality was 12.1%. Survival rate was 68.3 ± 3.0%, 26.9 ± 2.9%, and 5.3 ± 2.0% at one-, 5- and 10-years, respectively. Using surgical definition, only one patient required reintervention for symptomatic SVD and freedom from SVD at 10y was 93.8 ± 6.1%. According to our definition, 1 patient had probable severe SVD, 2 had probable moderate SVD, 1 had possible moderate SVD and freedom from SVD at 10 y was 87.7 ± 6.6% ( Fig. 1 ). Our data do not demonstrate an alarm on durability. Long-term assessment of transcatheter aortic valve is difficult given the high mortality of the studies population. Further studies are required to estimate accurately TAVI durability. When assessing SVD and comparing TAVI to surgery, SVD definition should be universal.

Transcatheter aortic valve replacement

The standard treatment for symptomatic severe aortic valve stenosis is surgical aortic valve replacement. Over the last decade, transcatheter aortic valve replacement has emerged as an option for patients judged inoperable. It might also constitute an alternative for high-risk patients, even though which patients might benefit from this approach is still being discussed and remains controversial. Transcatheter heart valve replacement is a rapidly spreading technology. However, a number of problems still need to be addressed, such as paravalvular regurgitation, stroke rate, and postoperative conduction disturbances. Further, the durability of transcatheter heart valves remains unclear. Randomized clinical trials and long-term follow-up will help