Transcatheter Aortic Bioprosthesis Research Articles

Surgical Technique And Clinical Implications Of Transcatheter Aortic Valve Bioprosthesis Explantation.

There has been a worldwide rapid adoption of transcatheter aortic valve replacement (TAVR) as an alternative to surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis. Currently, more TAVR explants with SAVRs are performed than TAVR-in TAV. TAVR explantation is a technically hazardous procedure mainly due to significant aortic neo-endothelialization which incorporates the TAVR valve. Surgical techniques for TAVR explantation are not well established and surgeon experience at present is limited. In this manuscript, we describe our technique for surgical explantation of transcatheter aortic bioprosthesis. Familiarity with the procedure and its clinical implications is essential for all cardiac surgeons.

Macroscopic findings of severe structural valve deterioration of a transcatheter aortic bioprosthesis.

Macroscopic findings of severe structural valve deterioration of a transcatheter aortic bioprosthesis.

Transcatheter aortic valve implantation for failed surgical and transcatheter prostheses. Expert opinion of the Association of Percutaneous Cardiovascular Interventions of the Polish Cardiac Society.

Over 15 years of clinical experience and multiple large-scale observational studies followed by guidelines show good safety and efficacy of valve-in-valve transcatheter aortic valve implantation TAVI (ViV-TAVI), which reduces the need for re-do surgical aortic valve replacement (SAVR) in high-risk patients. The number of procedures in Poland, estimated as ca. 2% of all TAVIs in 2020, is expected to rise. This article aims to review specific challenges of the ViV-TAVI procedure including proper pre-procedural planning to achieve best possible hemodynamic results and mitigate coronary occlusion risk. It also provides a preliminary review and guidelines on repeat TAVI (re-do TAVI) in patients presenting with a failed transcatheter aortic bioprosthesis.

Cardiac Reoperations in Patients With Transcatheter Aortic Bioprosthesis

BackgroundDespite the rapid adoption of transcatheter aortic valve replacement (TAVR), the frequency and clinical outcomes of reoperation after TAVR are not well-described. MethodsBetween 2011 and 2020, 1719 patients underwent a TAVR at our institution. Among these, 32 patients (2%) required a reoperation. Additionally, 16 patients who received a TAVR at another institution received a reoperation at our institution. We retrospectively reviewed these 48 patients. The median interval from TAVR to reoperation was 2.3 years. ResultsPrimary reoperations included 37 TAVR valve explants (TAVR-explant; 77%) with surgical aortic valve replacement (SAVR), 8 mitral repairs/replacements (17%), 2 coronary artery bypass grafting procedures (4%), and 1 tricuspid valve replacement (2%). Forty-nine percent of nonaortic valve cardiac lesions were present at the time of TAVR. Furthermore, 18 TAVR-explant patients (49%) were deemed anatomically unsuitable for repeat TAVR based on the index TAVR imaging. During TAVR-explant, 6 patients (13%) with native TAVR sustained various degrees of aortic trauma. Patients with unplanned aortic repair demonstrated a smaller sinotubular junction diameter than those without unplanned repair. In contrast, no unplanned aortic repair was needed in the 14 patients with previous SAVR or the latest 20 consecutive patients. The overall in-hospital mortality was 15%, with an observed-to-expected morality ratio of 1.8. ConclusionsThe clinical impact of post-TAVR reoperation remains substantial despite the lower frequency of unplanned aortic repair over time. The necessity of reoperations or unfavorable repeat TAVR anatomy appears predictable at the time of the index TAVR, and implanters must be mindful of “lifetime management” strategy during candidate selection.

TCT-494 The Evolut Supra-Annular, Self-Expanding Transcatheter Aortic Bioprosthesis Provides Symmetric Scaffolding for Leaflet Coaptation Despite Variable Annular Morphology

TCT-494 The Evolut Supra-Annular, Self-Expanding Transcatheter Aortic Bioprosthesis Provides Symmetric Scaffolding for Leaflet Coaptation Despite Variable Annular Morphology

The current practice of transcatheter aortic valve replacement in China.

The purpose of this study is to summarize the current practice and experience of transcatheter aortic valve replacement in China. The relevant articles were identified through computerized searches of the CNKI, WANFANG, VIP, and PubMed databases through February 1, 2022, using the search terms: "transcatheter aortic valve replacement," "transcatheter aortic valve implantation,""China." The database searches identified 22 articles, 2092 patients, 57.65% were male, with a mean age of 74.2 ± 6.0 years, 71.51% of patients were classified by New York Heart Association as class Ⅲ/Ⅳ, Society of Thoracic Surgeons score 8.4 ± 4.1, mean left ventricular ejection fraction 52.8 ± 14.2%, mean transvalvular aortic pressure gradient 59.9 ± 18.9 mmHg. The overall procedural success rate was 97.85%, and 2.15% of patients were converted to sternotomy, mainly due to transcatheter aortic bioprosthesis dislocation. The most common vascular access approach was transfemoral (1071 patients, 51.20%). General anesthesia (48.90%) was the commonly used anesthesia technique. The incidence of postprocedural complications was as follows: permanent pacemaker implantation (10.47%), bleeding events (8.60%), mild paravalvular leakage (17.73%), moderate and severe paravalvular leakage (4.16%), vascular complications (3.30%), stroke (1.43%), respectively. The overall periprocedural period and postprocedural 30-day mortality was 2.72%. Among patients undergoing transcatheter aortic valve replacement in China, device implantation success was achieved in 97.85% of cases. The most common vascular access approach was transfemoral. General anesthesia was the most commonly used anesthetic technique. Paravalvular leakage (458 patients, 21.89%) was the most common complication.

Transcatheter Aortic Bioprosthesis Durability: A Single-Center Experience

BackgroundTranscatheter aortic valve implant (TAVI) is gaining momentum in the treatment of severe, symptomatic aortic valve stenosis, and its indication is expanding to lower surgical risk individuals, who are generally younger and have a long life expectancy. Therefore, transcatheter bioprostheses durability appears of critical importance. Aim of the present study is to evaluate mid-term outcomes of TAVI in a high-volume single center cohort. MethodsWe analyzed all consecutive patients (n = 408) who underwent transfemoral TAVI at a single, high-volume center, between 2007 and 2014. Study objectives were all-cause death and bioprosthetic valve failure (BVF) at long term follow-up. Structural valve deterioration (SVD), BVF and valve-related death were defined according to current international standards. Follow-up was performed by in person visit and transthoracic echocardiography, which was obtained only in a minority of patients, or phone call as per patient preference. ResultsAt a median follow-up of 1821 days, overall mortality was 64.5%, with cardiovascular disease accounting for roughly half of total deaths. Valve-related deaths occurred in 10 patients. Seventeen patients were diagnosed with BVF, and 15 required repeat intervention. Moderate and severe SVD were observed in 10 and 7 patients, respectively. In the subgroup of patients with echocardiographic mid-term follow-up (n = 76), no significant increase of transprosthetic gradients nor increase of significant regurgitation was detected. ConclusionIn the present unselected, all-comers cohort, TAVI bioprostheses appeared to have excellent durability at long-term follow-up.

Surgical explantation of transcatheter aortic bioprosthesis: A systematic review and meta-analysis

BackgroundDespite the rapid adoption of transcatheter aortic valve replacement (TAVR), aortic valve reintervention, particularly surgical TAVR valve explantation (TAVR explant), has not been well described. MethodsMEDLINE, Embase, and Web of Science were searched through July 2021 to identify observational studies and case series reporting clinical outcomes of TAVR explant. Data on the frequency of TAVR explant, patient demographic characteristics, clinical indications, operative data, and perioperative outcomes were extracted. Study-specific estimates were combined using one-group meta-analysis in a random-effects model. ResultsA total of 10 studies were identified that included 1690 patients undergoing a TAVR explant. The frequency of TAVR explant among TAVR recipients was 0.4% (95% confidence interval [CI], 0.2%-0.6%). The mean patient age was 73.7 years (95% CI, 72.9-74.6 years). The mean Society of Thoracic Surgeons predicted risk of mortality was 5.9% (95% CI, 2.9%-8.8%) at the index TAVR and 8.1% (95% CI, 5.4%-10.8%) at TAVR explant. The mean time from implant to explant was 345.0 days (95% CI, 196.7-493.3 days). Among patients with documented device type, 59.8% (95% CI, 43.5%-76.0%) had a balloon-expandable valve and 40.2% (95% CI, 24.0%-56.5%) had a self-expandable valve. Concomitant procedures during TAVR explant were performed in 52.9% of patients (95% CI, 33.8%-72.0%), and the most common concomitant procedure was aortic repair (28.5%; 95% CI, 14.0%-42.9%). The 30-day mortality after TAVR explant was 16.7% (95% CI, 12.2%-21.2%). ConclusionsTAVR explant in patients with a failing TAVR appears to be rare; however, the clinical impact of TAVR explant is substantial. Implanters must be mindful of the need for a lifetime management strategy in younger and lower-risk patients when choosing the valve type for the initial procedure.

Safe Late Explantation of Transcatheter Aortic Bioprosthesis

Late explantation of transcatheter aortic biprosthesis with surgical aortic valve replacement is distinctively different from immediate rescue transcatheter valve explant, posing additional challenges due to the sickness of patients, severely adherent transcatheter device to the surrounding structure, and frequently necessary other concurrent procedures. There is clearly a learning curve for late explantation of transcatheter valves, whereas there is limited information with respect to the specific surgical technique for this entity. Herein I describe the key preoperative factors and critical steps of the surgical technique that will facilitate a safe device explantation.

TAVI-in-homograft (TiH): open transcatheter aortic valve replacement in calcified aortic homograft case reports

BackgroundRedo surgery in patient who underwent aortic valve replacement with an aortic homograft can result technically challenging because of the massive calcification of the conduit.Case presentationWe present a case of a patient who underwent open surgery on cardiopulmonary bypass assistance to implant a standard transcatheter aortic bioprosthesis through aortotomy in an off-label procedure and we discuss its safety and feasibility.ConclusionsThe combination of open cardiac surgery and open trans-aortic implant of a transcatheter prosthesis may reduce the surgical risk shrinking the technical difficulties that the implantation of a standard surgical prosthesis would have given.

Long-term results and durability of the CoreValve transcatheter aortic bioprosthesis: outcomes beyond five years.

The aim of this study was to determine the long-term outcomes of high-risk patients who underwent transcatheter aortic valve implantation (TAVI) with the third-generation CoreValve device, according to the 2017 EAPCI/ESC/EACTS definition of valve durability. Between 2007 and 2013, 278 consecutive patients were enrolled in our prospective single-centre CoreValve registry (mean age 82±6 years, mean STS score 6.4±5.0%). The median follow-up of survivors was 6.8 years. The Cox proportional hazards model was used to identify independent predictors of HF rehospitalisation and all-cause mortality. Predictors of HF rehospitalisation were LVEF, MR and PVL at the last echocardiographic follow-up. The majority of patients were in NYHA Class I or II and showed mild/trivial paravalvular leak throughout follow-up. Mean pressure gradients remained stable over time. The overall crude cumulative incidences of structural valve deterioration and bioprosthetic valve failure were 3.6% and 2.5%, respectively. Although overall mortality was high in this elderly patient cohort, the CoreValve bioprosthesis showed good durability at seven-year follow-up.

Commissural Alignment of Bioprosthetic Aortic Valve and Native Aortic Valve Following Surgical and Transcatheter Aortic Valve Replacement and its Impact on Valvular Function and Coronary Filling

ObjectivesThe aim of this study was to assess the commissural alignment between bioprosthetic and native aortic valve leaflets following surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) and to investigate its impact on valvular function and coronary filling. BackgroundExpansion and geometry have been shown to affect leaflets of implanted transcatheter aortic bioprosthesis, but commissural alignment has not been studied. MethodsPre- and post-procedural multidetector computed tomography (MDCT) of 28 SAVR patients and 212 TAVR patients were analyzed. Commissural alignment between the bioprosthetic (post) and native (pre) aortic valves was categorized as aligned (0° to 15° angle deviation) or as mild (15° to 30°), moderate (30° to 45°), or severe (45° to 60°) commissural misalignment (CMA). ResultsWith SAVR, 27 of 28 cases (96%) were aligned and 1 had mild CMA. For all types of transcatheter heart valves (THVs), there was random valve implantation with regard to commissural alignment: 22% of THVs were aligned, 25% had mild CMA, 22% had moderate CMA, and 31% had severe CMA. The degree of commissural alignment was not associated with a difference in transvalvular gradient, paravalvular aortic regurgitation, or simulated coronary filling. However, there was a significantly higher rate of mild central aortic regurgitation in those THVs with moderate or greater CMA compared with those THV with mild or less CMA (7.8% vs. 1.1%; p = 0.03). ConclusionsCommissural alignment is excellent in case of SAVR but random in case of TAVR. There is no association between CMA and transvalvular gradient or coronary filling; however, there is a significantly higher rate of mild central aortic regurgitation in case of moderate or greater CMA.

TCTAP A-162 Late Recoil of Balloon-expandable Transcatheter Aortic Bioprosthesis: Insights from the OCEAN-TAVI Registry

TCTAP A-162 Late Recoil of Balloon-expandable Transcatheter Aortic Bioprosthesis: Insights from the OCEAN-TAVI Registry

First North American experience with the transfemoral ACURATE-neoTM self-expanding transcatheter aortic bioprosthesis.

Transcatheter aortic valve implantation (TAVI) has become a therapeutic alternative for patients presenting with severe symptomatic aortic stenosis and considered at high-surgical risk. Paravalvular leak (PVL), conduction disorders, and coronary obstruction remain unresolved procedure-related complications. The aim of this manuscript was to report the first North American experience with the ACURATE-neoTM aortic bioprosthesis and its ACURATE-TFTM delivery system (Symetis S.A., Ecublens, Switzerland). Transfemoral ACURATE-neoTM aortic valve implantation was performed in 20 patients. Clinical and echocardiographic assessment was performed at baseline, postprocedure and at least 30 days. Outcomes were assessed according to valvular academic research consortium (VARC-2) criteria. The mean age was 82.7 ± 7.0 years with a mean logistic-EuroSCORE-II of 5.0 ± 2.9% and Society of Thoracic Surgeons score of 4.7 ± 2.3%. Device success was achieved in all patients. The mean distance between the aortic-annulus and the left main coronary artery ostium was 14.3 ± 3.2 mm, and eight (40%) patients had <12 mm. At 30 days, there were no deaths, conversions to surgery, or major procedure-related complications. New-pacemaker implantation was required in one (5.3%) patient. ACURATE-neoTM implantation resulted in a significant reduction in mean transvalvular gradient (49.9 ± 15.8 to 9.7 ± 5.7 mm Hg, P < 0.0001) and increase in effective-orifice area (0.65 ± 0.16 to 1.83 ± 0.36 cm2 , P = 0.001) at hospital discharge. Paravalvular leak was absent in four (20%) patients, trace in nine (45%) patients, and mild in seven (35%) patients. Hospital discharge occurred at a mean of 7.0 ± 4.5 days, and all patients were in NYHA class I-II at a mean follow-up of 8.6 ± 2.3 months. The present initial North American experience shows that the ACURATE-neoTM aortic bioprosthesis was safely and successfully implanted by transfemoral approach. The special design of this newer-generation device affords a stable and predictable implantation, while providing optimal hemodynamic performance with a relatively low rate of PPI. © 2016 Wiley Periodicals, Inc.

Surgical antegrade transcatheter mitral valve implantation for symptomatic mitral valve disease and heavily calcified annulus

Surgical techniques for the treatment of mitral valve disease (MVD) have continuously evolved; however, anatomical details like severe annular calcification remain challenging and require sophisticated surgical strategies. Among patients with symptomatic MVD referred for surgical valve repair or replacement, four presented with circumferential calcification of the mitral annulus precluding conventional surgical techniques. Successful treatment by implanting a balloon-expandable transcatheter aortic heart valve using an antegrade surgical access was performed. The perioperative course and follow-up assessment (19.3 ± 21 months) were uneventful. Echocardiographic assessment confirmed a well-seated valve with normal function (mean 4.5 ± 0.6 mmHg). Surgical mitral valve replacement using a balloon-expandable transcatheter aortic bioprosthesis can be a valuable and attractive bailout strategy in patients with a heavily calcified mitral annulus.

Superficial femoral artery access for transcatheter aortic valve replacement.

Different vascular accesses have been described for the delivery of a transcatheter aortic bioprosthesis. We report the use of the superficial femoral artery (SFA) as the arterial site of puncture with surgical cut-down. It may be a reasonable access alternative to the other classical routes, especially in the setting of either obese patients with elevated body mass index or in the presence of high femoral artery bifurcation. This route seems to be feasible with a low-profile risk.

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

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

Successful percutaneous implantation of Symetis ACURATE neo transcatheter aortic bioprosthesis in a patient with existing mechanical mitral valve.

Successful percutaneous implantation of Symetis ACURATE neo transcatheter aortic bioprosthesis in a patient with existing mechanical mitral valve.

Improvement of Mitral Regurgitation after Transapical Transcatheter Aortic Valve Bioprosthesis Implantation

Implantation of transcatheter aortic bioprosthesis has become a procedure with increasingly relevance in medical practice for the treatment of aortic stenosis, especially in patients with high or prohibitive surgical risk for traditional surgery. The presence of mitral regurgitation (MR) may be associated with increased morbidity and mortality, however, some studies have shown reduction in the degree of regurgitation of this valve after treatment of the aortic valve.

Implante por cateter de bioprótese valvar para tratamento da estenose aórtica: experiência de três anos

Transcatheter aortic bioprosthesis implantation is a new treatment modality for patients with aortic stenosis who are inoperable or at high surgical risk. To report the three-year experience with transcatheter CoreValve® bioprosthesis implantation. From January 2008 to January 2011, 35 patients with aortic stenosis (33) or aortic valve bioprosthesis dysfunction (two) at high surgical risk underwent transcatheter CoreValve® bioprosthesis implantation. The patients' mean age was 81.5 ± 9 years, and 80% had heart failure functional class III or IV. The EuroScore was 18.4 ± 14.3% and the STS risk score was 14.5 ± 11.6%. Successful device implantation was achieved in 34 (97.1%) patients. After the intervention, a reduction in the transvalvular pressure gradient from 84.9 ± 22 to 22.5 ± 9.5 mm Hg was observed, and 87.1% of the patients progressed to functional class I or II. Thirty-day mortality and mortality in the follow-up of 400 ± 298 days were 11.4% and 31.4%, respectively. The occurrence of life-threatening hemorrhagic complications was the only independent predictor of cardiovascular mortality. Stroke occurred in 5.7% of the patients. Permanent pacemaker was required in 32.1% of the patients within the first month after the procedure. Transcatheter aortic bioprosthesis implantation is a safe and effective procedure to be used in patients with aortic stenosis at high surgical risk. The CoreValve® prosthesis proved to have mid-term efficacy in a three-year follow-up.