Durability Of Transcatheter Aortic Valves Research Articles

Five-Year Transcatheter Aortic Valve Replacement Outcomes in Chronic Hemodialysis vs. Non-Hemodialysis Patients Using Balloon-Expandable Devices.

Based on the results of a clinical trial in Japan, transcatheter aortic valve replacement (TAVR) for hemodialysis (HD) patients gained approval; however, mid-term TAVR outcomes and transcatheter aortic valve (TAV) durability in HD patients remain unexplored.Methods and Results: We analyzed background, procedural, in-hospital outcome, and follow-up data for 101 HD patients and 494 non-HD patients who underwent TAVR using balloon-expandable valves (SAPIEN XT or SAPIEN 3) retrieved from Osaka University Hospital TAVR database. Periprocedural mortality and TAVR-related complications were comparable between HD and non-HD patients. However, Kaplan-Meier analysis revealed that HD patients had significantly lower survival rates (log-rank test, P<0.001). In addition, HD patients had significantly higher rates of severe structural valve deterioration (SVD) than non-HD patients (Gray test, P=0.038). TAVR in HD patients had comparable periprocedural mortality but inferior mid-term survival and TAV durability than in non-HD patients. Indications for TAVR in younger HD patients should be carefully determined, considering the possibility of a TAV-in-TAV procedure when early SVD occurs.

Transcatheter aortic valve durability: a contemporary clinical review.

Encouraged by randomized controlled trials demonstrating non-inferiority of transfemoral transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) across all surgical risk categories, there has been a dramatic increase in the use of TAVI in a younger patient cohort with severe aortic stenosis, endorsed by both European and American Cardiac Societies. However, the standard use of TAVI in younger, less co-morbid patients with a longer life expectancy can only be supported if there is sound data demonstrating long-term durability of transcatheter aortic valves (TAVs). In this article, we have reviewed available randomized and observational registry clinical data pertaining to TAV long-term durability, placing emphasis on trials and registries using the new standardized definitions of bioprosthetic valve dysfunction (BVD) and bioprosthetic valve failure (BVF). Despite inherent difficulties in interpreting the available data, the determination reached is that the risk of structural valve deterioration (SVD) is potentially lower after TAVI than SAVR at 5 to 10 years, and that the two treatment modalities have a similar risk of BVF. This supports the adoption of TAVI in younger patients evident in current practice. However, the routine use of TAVI in younger patients with bicuspid aortic valve stenosis should be cautioned due to insufficient long-term TAV durability data in this particular patient population. Finally, we highlight the importance of future research into the unique potential mechanisms that can potentially contribute to TAV degeneration.

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.

Evaluation of structural valve deterioration and bioprosthetic valve failure utilizing the new European consensus definition in patients undergoing TAVI with first-generation devices: Outcomes beyond 5 years from a single center in Turkey.

The long-term durability of transcatheter aortic bioprosthetic valves continues to be a major concern. Standardized criteria of the structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) have recently been defined. Limited studies have evaluated the long-term durability of transcatheter aortic valve implantation (TAVI) according to these new definitions. We aim to analyze the durability of TAVI beyond 5 years and to report the frequency of SVD and BVF. A total of 89 patients who had undergone TAVI and had theoretically completed at least 5 years after the procedure were included. Either a Medtronic CoreValve or an Edwards SAPIEN XT valve were implanted in the patients. New standardized definitions were used to evaluate SVD and BVF. The mean age of the patients was 78.70±6.95 years. SVD occured in 4 (4.5%) patients during 6 years of follow-up. Severe SVD was observed in 2 patients (2.2%), and these patients had the New York Heart Association class II symptoms. Both patients with severe SVD also met the criteria of BVF. Moderate SVD was observed in 2 patients (2.2%), and these patients had no valve-related symptoms. Of the 4 SVD cases, 2 were associated with increased mean transaortic gradients, whereas the remaining 2 cases were associated with intraprosthetic aortic regurgitation. All patients with SVD are still alive, and none of them have required aortic valve reintervention. Although first-generation TAVI devices were used, we determined the low rate of SVD and BVF at the 6-year follow-up. It may be suggested that there is no major concern associated with TAVI even with first-generation devices regarding long-term durability.

Durability of transcatheter aortic valves, current evidence and future prospective

Vessel Plus is an open acccess journal, which publishes articles related to vascular diseases, including acute respiratory distress syndrome, aneurysm, atherosclerosis, hypertension, stroke, peripheral vascular or pulmonary vascular diseases, etc.

Assessment of long-term structural deterioration of transcatheter aortic bioprosthetic valves

The durability of transcatheter aortic bioprosthetic valves is a crucial issue in the context of extension of indications in younger and lower-risk patients, but data are scarce, especially beyond 5 years of follow-up. The aim of this study was to evaluate the incidence of structural valve degeneration (SVD). Demographic, procedural, and in-hospital outcome data on patients who underwent transcatheter aortic valve implantation (TAVI) from 2002 to 2020 were obtained from our prospective institutional database. Patients in whom echocardiographic data were available both at baseline and follow-up post-TAVI were included. Clinical and echocardiographic follow-up were performed on site annually. Hemodynamic SVD was determined according to European task force committee guidelines. A total of 1824 patients (83.6 ± 6.8 years of age; 53% female) with paired post-procedure and late echocardiographic follow-up (median 1.9 years, max 10.9 years) were included. Among them, 223 (12.3%) patients have a follow-up of more than 5 years. A self-expandable valve was used in 160 (8.8%) patients while the remaining patients were treated with, a balloon-expandable valve (91.2%). Mean aortic gradient and effective aortic valve area remained unchanged during follow-up. SVD occurred in 16 (0.9%) patients. SVD was moderate in 8 (0.4%) patients and severe in 8 (0.4%) patients. Four (0.4%) patients required redo-TAVI for severe SVD. Our data do not demonstrate any alarm signal on transcatheter aortic valve durability. Careful prospective assessment in younger and lower risk patients and comparison with surgical bioprosthetic valves are required to further assess long-term durability of transcatheter valves.

Incidence and Predictors of Structural Valve Deterioration after Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

Background Transcatheter aortic valve replacement (TAVR), widely used as an alternative therapy in patients with severe aortic stenosis, is expected to be offered to low-risk patents with a longer life expectancy. The durability of transcatheter aortic valve is becoming of increasing importance. Method PubMed, Embase, and Cochrane CENTRAL from the inception to March 2020 were systematically screened for studies reporting on structural valve deterioration (SVD) in TAVR patients. Incidence of SVD was diagnosed according to the latest European consensus as the primary end point. Predictors of SVD evaluated at multivariable analysis and cumulative incidence function (CIF) of SVD were the secondary end point. Result Twelve studies encompassing 10031 patients evaluating the incidence of SVD were included, with a follow-up between 1 and 8 years. The pooled incidence of SVD was 4.93% (95% CI, 2.75%–7.70%, I2 = 96%) at 1 year and 8.97% (95% CI, 6.89%–11.29%, I2 = 86%) in the long term (≥5 years). Subgroup analysis was performed to identify the valve type that may result in partial heterogeneity. SVD was more frequent in patents with a valve diameter of <26 mm (HR: 3.57, 1.47–8.69), oral anticoagulants (OAC), exposure at discharge (OR: 0.48, 0.38–0.61), or by a disease of renal dysfunction (OR 1.42, 1.03–1.96). Conclusion SVD represents infrequent events after TAVR in the long term (>5 years), occurring more commonly in renal dysfunction patients, with small valve diameter and without OAC exposure. There may be an underestimation of the incidence if we assume death as a competing risk.

Assessment of long-term structural deterioration of transcatheter aortic bioprosthetic valves

Abstract Background The durability of transcatheter aortic bioprosthetic valves is a crucial issue in the context of extension of indications in younger and lower-risk patients, but data are scarce, especially beyond 5 years of follow-up. This study sought to evaluate the incidence of structural valve degeneration (SVD) 5 to 10 years post-procedure. Methods Demographic, procedural, and in-hospital outcome data on patients who underwent transcatheter aortic valve implantation (TAVI) from 2002 to 2014 were obtained from our prospective institutional database. Patients in whom echocardiographic data were available both at baseline and 5 years post-TAVI were included. Clinical and echocardiographic follow-up were performed on site annually. Hemodynamic SVD was determined according to European task force committee guidelines. Results A total of 208 patients (82.5±7.6 years of age; 53% female) with paired post-procedure and late echocardiographic follow-up (median 5.3 years, range 5 to 11.4 years) were included. Eleven (5.3%) patients were treated with a self-expandable valve and 197 (94.7%) patients with a balloon-expandable valve. Mean aortic valve gradient and effective aortic valve area remained unchanged during follow-up. There were 2 cases (1.0%) of severe SVD 6 and 7 years after implantation requiring redo-TAVI. There were 4 cases (1.9%) of moderate SVD (mean 6.0 years post-implantation; range 5 to 7 years). Conclusions Our data do not demonstrate any alarm on transcatheter aortic valve durability. Careful prospective assessment in younger and lower risk patients and comparison with surgical bioprosthetic valves are required to further assess long-term durability of transcatheter valves. Funding Acknowledgement Type of funding source: None

Impact of Transcatheter Aortic Valve Durability on Life Expectancy in Low-Risk Patients With Severe Aortic Stenosis.

Recent clinical trial results showed that transcatheter aortic valve replacement (TAVR) is noninferior and may be superior to surgical aortic valve replacement (SAVR) for mortality, stroke, and rehospitalization. However, the impact of transcatheter valve durability remains uncertain. Discrete event simulation was used to model hypothetical scenarios of TAVR versus SAVR durability in which TAVR failure times were varied to determine the impact of TAVR valve durability on life expectancy in a cohort of low-risk patients similar to those in recent trials. Discrete event simulation modeling was used to estimate the tradeoff between a less invasive procedure with unknown valve durability (TAVR) and that of a more invasive procedure with known durability (SAVR). Standardized differences were calculated, and a difference >0.10 was considered clinically significant. In the base-case analysis, patients with structural valve deterioration requiring reoperation were assumed to undergo a valve-in-valve TAVR procedure. A sensitivity analysis was conducted to determine the impact of TAVR valve durability on life expectancy in younger age groups (40, 50, and 60 years). Our cohort consisted of patients with aortic stenosis at low surgical risk with a mean age of 73.4±5.9 years. In the base-case scenario, the standardized difference in life expectancy was <0.10 between TAVR and SAVR until transcatheter valve prosthesis failure time was 70% shorter than that of surgical prostheses. At a transcatheter valve failure time <30% compared with surgical valves, SAVR was the preferred option. In younger patients, life expectancy was reduced when TAVR durability was 30%, 40%, and 50% shorter than that of surgical valves in 40-, 50-, and 60-year-old patients, respectively. According to our simulation models, the durability of TAVR valves must be 70% shorter than that of surgical valves to result in reduced life expectancy in patients with demographics similar to those of recent trials. However, in younger patients, this threshold for TAVR valve durability was substantially higher. These findings suggest that durability concerns should not influence the initial treatment decision concerning TAVR versus SAVR in older low-risk patients on the basis of current evidence supporting TAVR valve durability. However, in younger low-risk patients, valve durability must be weighed against other patient factors such as life expectancy.

The hemodynamics of transcatheter aortic valves in transcatheter aortic valves

BackgroundThe durability of transcatheter aortic valves (TAVs) remains their greatest disadvantage, given that fixed tissue leaflets are not immune to structural degeneration from calcification and thrombosis. Therefore, a second intervention is necessary, especially given that TAV in low-risk patients has shown noninferior outcomes compared with surgery. This study aimed to assess the hemodynamic and turbulent properties of the flow downstream with different TAV-in-TAV configurations, to offer basic hemodynamic guidance for future interventions when currently implanted valves structurally degrade. MethodsSix TAV-in-TAV configurations were chosen: 23 mm Evolut-in-26 mm Evolut, 23 mm Evolut-in-23 mm SAPIEN 3, 26 mm Evolut-in-26 mm Evolut, 26 mm Evolut-in-23 mm SAPIEN 3, 23 mm SAPIEN3-in-26 mm Evolut, and 23 mm SAPIEN3-in-23 mm SAPIEN 3. Their hemodynamic performance was assessed in a pulse duplicator for 100 cycles. High-speed imaging and particle image velocimetry were performed to assess turbulence. Effective orifice area (EOA), pinwheeling index (PI), and Reynolds shear stress (RSS) were evaluated. ResultsThe largest mean EOA was obtained with 23 mm SAPIEN-in-26 mm Evolut (2.07 ± 0.06 cm2), and the smallest was obtained with 23 mm Evolut-in-23 mm SAPIEN (1.50 ± 0.04 cm2) (P < .001). The highest mean PI was obtained with SAPIEN-in-SAPIEN (26.5 ± 2.00%), and the lowest was obtained with 26 mm Evolut-in-26 mm Evolut (7.5 ± 1.6%) (P < .01). At peak systole, the least detrimental RSS range was obtained with 23 mm Evolut-in-26 mm Evolut (up to ∼340 Pa), and the most detrimental RSS range was obtained with 23 mm Evolut-in-SAPIEN (∼900 Pa) (P < .01). ConclusionsThis study shows that best hemodynamic parameters are TAV-specific (implanted and to be implanted). In addition, it shows that RSS levels, which are indicative of turbulence levels and associated with blood damage, are 2- to 3-fold higher after TAV-in-TAV.

Long-term Transcatheter Aortic Valve Durability.

Transcatheter aortic valve implantation (TAVI) has become the standard of care for high-risk and inoperable surgical patients and a valid alternative to surgery for low- and intermediate-risk patients with severe, symptomatic aortic stenosis. It is increasingly being used for younger, lower-risk patients, so it is important to ensure the durability for long-term transcatheter aortic valves. The lack of standard definitions of structural valve degeneration (SVD) had made comparison among studies on prosthetic valve durability problematic. The 2017 standardised definitions of SVD by the European Association of Percutaneous Cardiovascular Intervention), the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery, and the 2018 definitions by the Valve In Valve International Data group, has generated an increased uniformity in evaluations. This article examines the potential mechanisms and rates of SVD of transcatheter bioprostheses and the role of redo TAVI as a treatment option.

Detailed Stress Analysis of Edwards-SAPIEN and Medtronic CoreValve Devices. Is Leaflet Stress Comparable to Surgical Carpentier-Edwards PERIMOUNT Magna Bioprosthesis?

Objective: Transcatheter aortic valves (TAVs) are prone to structural valve deterioration resulting in limited long-term durability. However, data regarding long-term durability of TAVs are limited...

Degeneration of prosthesis after transcatheter aortic valve implantation.

With the expanding indication of transcatheter aortic valve implantation (TAVI) to younger, lower risk population, transcatheter aortic valve (TAV) long-term durability is becoming an emerging issue to face with. Recently, the standardization of structural valve deterioration (SVD) definition by a join committee of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) has permitted to evaluate for the first time the rates of TAV durability with comparable endpoint. A few studies reporting on structural valve dysfunction (SVD) after TAVI up to 8 years using these standardized criteria have found very low rates of valve deterioration, thus supporting the adoption of TAVI treatment even for younger patients. For patients showing SVD at follow-ups, the VIVID (Valve-in-Valve International Data) group recently proposed an algorithm for their management. Re-do TAVI seems to be a safer and valid alternative to re-do surgery for symptomatic patients. This article review will go through the current evidence of TAV durability, describing the types of failure and strategies of treatment.

TCT-651 Novel, preclinical model of aortic banding for evaluation of implantation feasibility and long term durability of transcatheter aortic valves

Animal models of transcatheter aortic valve implantation (TAVI) are limited to evaluation of device acute performance due to lack of underlying calcific aortic valve disease and anchoring mechanism. Early dislocation of the device is very common and disables assessment of long term performance,

P3599Novel, preclinical model of aortic banding for evaluation of implantation feasibility and long term durability of transcatheter aortic valves

P3599Novel, preclinical model of aortic banding for evaluation of implantation feasibility and long term durability of transcatheter aortic valves

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

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

Assessment of long-term durability of transcatheter aortic valves, a French multicenter retrospective study

Recommendations have upgraded transcatheter aortic valve implantation (TAVI) indications. It is currently an alternative to conventional surgery in intermediate risk patients. As the indications extended to patients with potentially longer life expectancy, the topic of durability of percutaneous aortic bioprostheses becomes crucial. We evaluated the durability of these bioprostheses through this French multicentric study offering the longest follow-up in Europe. All patients treated with TAVI in 5 French centers from 2002 to 2011 were included. Bioprosthetic valve failure (BVF) was defined as repeated intervention or severe structural valve deterioration (SVD). Patients selected for the durability analysis were those who had an echocardiography at least one year before the last follow-up. SVD was evaluated according to the recent definition: moderate when mean transprosthetic gradient was > 20 mmHg and < 40 mmHg with an increase of > 10 and < 20 mmHg and/or with a moderate intra-prosthetic aortic regurgitation (AR), new or worsening from baseline; severe when mean gradient was > 40 mmHg with an increase of > 20 mmHg and/or with a severe intra-prosthetic AR. During this period 1403 patients were included. Mean duration follow-up was 3.6 ± 2.1 years, maximum duration was 10.2 years. Survival rates were 39.1% (95% CI: 36.3–41.8) and 13.4% (95% CI: 9.7–17.0) at respectively 5 and 8 years. In total, 589 patients were eligible for the durability analysis (46.6%). BVF occurred in 18 patients (1.4%). Among them, 5 patients required re-intervention. Risk of BVF at 10 years was 3.4% (95% CI: 1.7–5.9). Moderate SVD occurred in 41 patients (7.0%), risk of moderate SVD was 17.0% (95% CI: 9.1–26.0) at 10 years. Severe SVD occurred in 15 patients (2.5%), risk of severe SVD was 8.0% (95% CI: 3.3–15.2) at 10 years. Our study does not highlight any alarm signal concerning percutaneous aortic bioprostheses durability.

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.

TCT-790 Long-term follow-up after transcatheter aortic valve implantation and durability of transcatheter aortic valves - results of a prospective single-center registry

Transcatheter aortic valve replacement (TAVR) has become the standard of care for inoperable patients and higher risk patients with severe symptomatic aortic valve stenosis over the last years. Complication rates decreased over time and outcomes improved considerably. Data from recent studies and

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

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