Transcatheter Bioprosthetic Aortic Valves Research Articles

Transcatheter Aortic Valve Replacementin Failed TranscatheterBioprostheticValves.

Transcatheter aortic valve replacement (TAVR) is increasingly being performed in younger and lower surgical risk patients. Given the longer life expectancy of these patients, the bioprosthetic valve will eventually fail, and aortic valve reintervention may be necessary. Although currently rare, redo-TAVR will likely increase in the future as younger patients are expected to outlive their transcatheter bioprosthesis. This review provides a contemporary overview of the indications, procedural planning, implantation technique, and outcomes of TAVR in failed transcatheter bioprosthetic aorticvalves.

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.

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.

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

Durability of transcatheter bioprosthetic aortic valves: the story so far.

Durability of transcatheter bioprosthetic aortic valves: the story so far.

Assessment of Long-Term Structural Deterioration of Transcatheter Aortic Bioprosthetic Valves Using The New European Definition: A Multicenter French Study

Assessment of Long-Term Structural Deterioration of Transcatheter Aortic Bioprosthetic Valves Using The New European Definition: A Multicenter French Study

Assessment of Long-Term Structural Deterioration of Transcatheter Aortic Bioprosthetic Valves Using the New European Definition.

The durability of transcatheter aortic bioprosthetic valves is a crucial issue, but data are scarce, especially beyond 5 years of follow-up. We aimed to assess long-term (7 years) structural valve deterioration (SVD) and bioprosthetic valve failure of transcatheter aortic bioprosthetic valves. Consecutive patients with at least 5-year follow-up available undergoing transcatheter aortic valve implantation from April 2002 to December 2011 in 5 French centers were included. Incidence of SVD and bioprosthetic valve failure were defined according to newly standardized criteria of the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery and reported as cumulative incidence function to account for the competing risk of death. One thousand four hundred three consecutive patients were included with a mean age of 82.6±7.5 years and with a mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) of 21.3±7.5%. A balloon-expandable valve was used in 83.7% of cases. Survival rates were 83.5% (95% CI, 81.4%-85.5%) and 18.6% (95% CI, 15.3%-21.8%) at 1 and 7 years, respectively. Median duration of follow-up was 3.9 years. Bioprosthetic valve failure occurred in 19 patients with a 7-year cumulative incidence of 1.9% (95% CI, 1.4%-2.4%). SVD occurred in 49 patients (moderate, n=32; severe, n=17) with a 7-year cumulative incidence of moderate and severe SVD of 7.0% (95% CI, 5.6%-8.4%) and 4.2% (95% CI, 2.9%-5.5%), respectively. Five patients had aortic valve reintervention (1.0%; 95% CI, 0.4%-1.6%) including 1 case of surgical aortic valve replacement and 4 redo-transcatheter aortic valve implantation. The incidences of SVD and bioprosthetic valve failure were not significantly different between balloon and self-expandable prostheses. The long-term assessment of transcatheter aortic bioprosthetic valves durability is limited by the poor survival of our population beyond 5 years. Further studies are warranted, particularly in younger and lower-risk patients.

Assessment of long-term structural deterioration of transcatheter aortic bioprosthetic valves using standardized new European definitions, a multicenter French study

In the context of extension of transcatheter aortic valve implantation (TAVI) indications to lower-risk patients, long-term durability of transcatheter aortic bioprosthetic valves (TABV) is a crucial issue. There is a paucity of data, especially beyond 5 years of follow-up. Recently, new definitions have been proposed to assess structural valve deterioration (SVD) and bioprosthetic valve failure (BVF). We aim to assess long-term SVD and BVF of TABV using standardized new definitions. All TAVI patients implanted between 2002 and 2011 in 5 French centers were included. One month and last available echocardiographic follow-up were used to assess SVD and BVF of according to the new European criteria. Competing-risk analysis was used to assess SVD and BVF incidence. From 2002 to 2011, 1403 patients were included. Mean age and logistic EuroSCORE were 82.6 ± 7.5 years and 21.3 ± 7.5%. Mean duration follow-up was 3.6 ± 2.1 years with a maximum of 10.2 years. Survival rates were 83.5% (95% CI: 81.4–85.5), 18.6% (95% CI: 15.3–21.8) and 8.0% (95% CI: 1.9–14.2) at 1, 7 and 10 years, respectively. BVF occurred in 18 patients of whom 5 required reoperation with a mean delay of 5.5 ± 1.3 years. Incidence of BVF was 2.2% (95% CI: 1.2–3.7) and 3.4 (95% CI: 1.7–5.9) at 7 and 10 years, respectively. Among 589 patients eligible for the SVD analysis, 41 had moderate SVD and 15 had severe SVD. Incidence of moderate SVD was 9.2% (95% CI: 6.5–12.6) and 16.6% (95% CI: 9.1–26.0) at 7 and 10 years, respectively. Incidence of severe SVD was 4.4% (95% CI: 2.2–7.9) and 8.0% (95% CI: 3.3–15.2) at 7 and 10 years, respectively. Despite the low survival rates of the early treated TAVI population in France, we believe reporting the longest follow-up available. Our study does not highlight any alarm signal concerning late durability of TABV. Further studies are warranted to assess long-term durability of TABV particularly in younger and lower risk-patients.

Invited Commentary

Invited Commentary

3071Assessment of long-term structural deterioration of transcatheter aortic bioprosthetic valves using standardized new european definitions, a multicenter study

3071Assessment of long-term structural deterioration of transcatheter aortic bioprosthetic valves using standardized new european definitions, a multicenter study

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.

Standardized Definition of Structural Valve Degeneration for Surgical and Transcatheter Bioprosthetic Aortic Valves.

Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses.

Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study

Subclinical leaflet thrombosis of bioprosthetic aortic valves after transcatheter valve replacement (TAVR) and surgical aortic valve replacement (SAVR) has been found with CT imaging. The objective of this study was to report the prevalence of subclinical leaflet thrombosis in surgical and transcatheter aortic valves and the effect of novel oral anticoagulants (NOACs) on the subclinical leaflet thrombosis and subsequent valve haemodynamics and clinical outcomes on the basis of two registries of patients who had CT imaging done after TAVR or SAVR. Patients enrolled between Dec 22, 2014, and Jan 18, 2017, in the RESOLVE registry, and between June 2, 2014, and Sept 28, 2016, in the SAVORY registry, had CT imaging done with a dedicated four-dimensional volume-rendered imaging protocol at varying intervals after TAVR and SAVR. We defined subclinical leaflet thrombosis as the presence of reduced leaflet motion, along with corresponding hypoattenuating lesions shown with CT. We collected data for baseline demographics, antithrombotic therapy, and clinical outcomes. We analysed all CT scans, echocardiograms, and neurological events in a masked fashion. Of the 931 patients who had CT imaging done (657 [71%] in the RESOLVE registry and 274 [29%] in the SAVORY registry), 890 [96%] had interpretable CT scans (626 [70%] in the RESOLVE registry and 264 [30%] in the SAVORY registry). 106 (12%) of 890 patients had subclinical leaflet thrombosis, including five (4%) of 138 with thrombosis of surgical valves versus 101 (13%) of 752 with thrombosis of transcatheter valves (p=0·001). The median time from aortic valve replacement to CT for the entire cohort was 83 days (IQR 33-281). Subclinical leaflet thrombosis was less frequent among patients receiving anticoagulants (eight [4%] of 224) than among those receiving dual antiplatelet therapy (31 [15%] of 208; p<0·0001); NOACs were equally as effective as warfarin (three [3%] of 107 vs five [4%] of 117; p=0·72). Subclinical leaflet thrombosis resolved in 36 (100%) of 36 patients (warfarin 24 [67%]; NOACs 12 [33%]) receiving anticoagulants, whereas it persisted in 20 (91%) of 22 patients not receiving anticoagulants (p<0·0001). A greater proportion of patients with subclinical leaflet thrombosis had aortic valve gradients of more than 20 mm Hg and increases in aortic valve gradients of more than 10 mm Hg (12 [14%] of 88) than did those with normal leaflet motion (seven [1%] of 632; p<0·0001). Although stroke rates were not different between those with (4·12 strokes per 100 person-years) or without (1·92 strokes per 100 person-years) reduced leaflet motion (p=0·10), subclinical leaflet thrombosis was associated with increased rates of transient ischaemic attacks (TIAs; 4·18 TIAs per 100 person-years vs 0·60 TIAs per 100 person-years; p=0·0005) and all strokes or TIAs (7·85 vs 2·36 per 100 person-years; p=0·001). Subclinical leaflet thrombosis occurred frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. Anticoagulation (both NOACs and warfarin), but not dual antiplatelet therapy, was effective in prevention or treatment of subclinical leaflet thrombosis. Subclinical leaflet thrombosis was associated with increased rates of TIAs and strokes or TIAs. Despite excellent outcomes after TAVR with the new-generation valves, prevention and treatment of subclinical leaflet thrombosis might offer a potential opportunity for further improvement in valve haemodynamics and clinical outcomes. RESOLVE (Cedars-Sinai Heart Institute) and SAVORY (Rigshospitalet).

Bioprosthetic surgical and transcatheter heart valve thrombosis

Excellent outcomes of transcatheter aortic valve replacement (TAVR) have been experienced by patients with aortic stenosis at high and intermediate risk of surgery. 1 Vahl TP Kodali SK Leon MB Transcatheter aortic valve replacement 2016: a modern-day “Through the Looking-Glass” adventure. J Am Coll Cardiol. 2016; 67: 1472-1487 Crossref PubMed Scopus (106) Google Scholar Findings from large randomised trials 1 Vahl TP Kodali SK Leon MB Transcatheter aortic valve replacement 2016: a modern-day “Through the Looking-Glass” adventure. J Am Coll Cardiol. 2016; 67: 1472-1487 Crossref PubMed Scopus (106) Google Scholar , 2 Dangas GD Weitz JL Giustino G Makkar R Mehran R Prosthetic heart valve thrombosis. J Am Coll Cardiol. 2016; 68: 2670-2689 Crossref PubMed Scopus (225) Google Scholar have shown survival with TAVR that is similar to or improved compared with bioprosthetic surgical aortic valve replacement (SAVR), and very low stroke rates have been observed with new-generation devices. Investigators of echocardiographic follow-up studies 3 Daubert MA Weissman NJ Hahn RT et al. Long-term valve performance of TAVR and SAVR: a report from the PARTNER I trial. JACC Cardiovasc Imaging. 2017; 10: 15-25 Crossref Scopus (73) Google Scholar have consistently reported low transvalvular gradients up to 5 years after TAVR and SAVR, with slightly greater aortic valve areas after TAVR than after SAVR. Against this background, the occurrence of subclinical valve leaflet thrombosis in patients, detected with CT after TAVR or SAVR, has been described. 4 Makkar RR Fontana G Jilaihawi H et al. Possible subclinical leaflet thrombosis in bioprosthetic aortic valves. N Engl J Med. 2015; 373: 2015-2024 Crossref PubMed Scopus (736) Google Scholar Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational studySubclinical leaflet thrombosis occurred frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. Anticoagulation (both NOACs and warfarin), but not dual antiplatelet therapy, was effective in prevention or treatment of subclinical leaflet thrombosis. Subclinical leaflet thrombosis was associated with increased rates of TIAs and strokes or TIAs. Despite excellent outcomes after TAVR with the new-generation valves, prevention and treatment of subclinical leaflet thrombosis might offer a potential opportunity for further improvement in valve haemodynamics and clinical outcomes. Full-Text PDF