Surgical Bioprosthetic Valves Research Articles

Bioprosthetic Aortic Valve Thrombosis: Definitions, Clinical Impact, and Management: A State-of-the-Art Review.

Bioprosthetic aortic valve thrombosis is frequently detected after transcatheter and surgical aortic valve replacement due to advances in cardiac computed tomography angiography technology and standardized surveillance protocols in low-surgical-risk transcatheter aortic valve replacement trials. However, evidence is limited concerning whether subclinical leaflet thrombosis leads to clinical adverse events or premature structural valve deterioration. Furthermore, there may be net harm in the form of bleeding from aggressive antithrombotic treatment in patients with subclinical leaflet thrombosis. This review will discuss the incidence, mechanisms, diagnosis, and optimal management of bioprosthetic aortic valve thrombosis after transcatheter aortic valve replacement and bioprosthetic surgical aortic valve replacement.

Self-expandable transcatheter valve is a potentially useful option for a failing small surgical aortic bioprosthetic valve.

Trans-catheter aortic valve implantation inside a failing surgical aortic valve bio-prosthesis has become an alternative for patients at high risk for redo surgical aortic valve replacement. However, the correlation between the size of the failing surgical aortic valve and the occurrence of prosthesis-patient mismatch after trans-catheter implantation is still controversial. The aim of this study is to analyze and report the results in Japanese patients. Thirty patients who underwent trans-catheter aortic valve implantation inside a failing surgical aortic valve at our hospital were retrospectively reviewed with results from echocardiography and computed tomography. The patients' mean age was 84.5 ± 4.8years. The mean body surface area was 1.42 ± 0.13 m2. The cohort was divided into two groups according to the size of the failing bio-prosthesis: small (≦19mm) and large (> 19mm). There were no significant differences in mean pressure gradient (12.2 ± 4.0mmHg vs. 11.1 ± 1.2mmHg; p = 0.54) and effective orifice area index (1.00 ± 0.26cm2/m2 vs. 0.99 ± 0.25cm2/m2; p = 0.92) between the groups at 6months after trans-catheter implantation. The incidence of moderate (38.5% vs. 28.6%; p = 0.59) and severe (0% vs. 7.1%; p = 0.33) prosthesis-patient mismatch was equivalent. There was no significant difference in survival between the two groups (log-rank test p-value = 0.08). Trans-catheter implantation inside a failing small aortic valve did not increase the frequency of prosthesis-patient mismatch in this Japanese cohort.

Non-vitamin K versus vitamin K antagonist oral anticoagulants in surgical mitral valve repair or bioprosthetic valve replacement in the first three months after surgery

Introduction and Objectives: Oral anticoagulation (OAC) with non-vitamin K antagonist oral anticoagulants (NOACs) after surgical mitral valve repair (MVR) or bioprosthetic valve replacement (BVR) in mitral position remains a controversial topic among the cardiovascular community, in particular in the early postoperative period. This study aimed to evaluate the efficacy and safety of NOACs in the first three months after MVR or mitral BVR compared to vitamin K antagonists (VKAs).Methods: This was a single-center retrospective study with prospectively collected peri-intervention outcomes between 2020 and 2021. Records were retrieved and all participants were contacted by telephone. Patients were divided into groups according to OAC strategy. The primary outcome was a composite of death, rehospitalization, myocardial infarction, stroke or transient ischemic attack, systemic embolism, mitral thrombosis, or bleeding during the first three months after surgery.Results: A total of 148 patients were enrolled, with a mean age of 65.5±12.2 years, 56.8% male. On discharge, 98 (66.2%) patients were on VKAs and 50 (33.8%) were on DOACs for at least three months. The primary outcome occurred in 22 (22.4%) patients in the VKA group and in three (6%) in the NOAC group (p=0.012), mainly driven by more bleeding events in the former. Independent predictors of the primary outcome were smoking (p=0.028) and OAC with VKAs at discharge, the latter predicting three times more events (p=0.046, OR 3.72, 95% CI 1.02-13.5).Conclusions: NOACs were associated with fewer events, supporting their efficacy and safety during the first three months after surgical MVR or mitral BVR.

Outcomes of Bioprosthetic Surgical Aortic Valve Replacement in Patients Younger Than 65 Years

Outcomes of Bioprosthetic Surgical Aortic Valve Replacement in Patients Younger Than 65 Years

Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study.

This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction. This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board. Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all (100%; 95% confidence interval [CI] 94-100.0%, p<0.001) patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 (98.3%; 95% CI [91.1-100%]) patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1-99.0%). Within 90 days, freedom from mortality was 95% (95% CI 86.1-99.0%]), without any cardiovascular deaths. Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favorable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.

Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses.

The objective of this analysis was to assess the normal haemodynamic performance of contemporary surgical aortic valves at 1 year postimplant in patients undergoing surgical aortic valve replacement for significant valvular dysfunction. By pooling data from 4 multicentre studies, this study will contribute to a better understanding of the effectiveness of surgical aortic valve replacement procedures, aiding clinicians and researchers in making informed decisions regarding valve selection and patient management. Echocardiograms were assessed by a single core laboratory. Effective orifice area, dimensionless velocity index, mean aortic gradient, peak aortic velocity and stroke volume were evaluated. The cohort included 2958 patients. Baseline age in the studies ranged from 70.1 ± 9.0 to 83.3 ± 6.4 years, and Society of Thoracic Surgeons risk of mortality was 1.9 ± 0.7 to 7.5 ± 3.4%. Twenty patients who had received a valve model implanted in fewer than 10 cases were excluded. Ten valve models (all tissue valves; n = 2938 patients) were analysed. At 1 year, population mean effective orifice area ranged from 1.46 ± 0.34 to 2.12 ± 0.59 cm2, and dimensionless velocity index, from 0.39 ± 0.07 to 0.56 ± 0.15. The mean gradient ranged from 8.6 ± 3.4 to 16.1 ± 6.2 mmHg with peak aortic velocity of 1.96 ± 0.39 to 2.65 ± 0.47 m/s. Stroke volume was 75.3 ± 19.6 to 89.8 ± 24.3 ml. This pooled cohort is the largest to date of contemporary surgical aortic valves with echocardiograms analysed by a single core lab. Overall haemodynamic performance at 1 year ranged from good to excellent. These data can serve as a benchmark for other studies and may be useful to evaluate the performance of bioprosthetic surgical valves over time. NCT02088554, NCT02701283, NCT01586910 and NCT01531374.

Transcatheter Aortic Valve Replacement for Failed Surgical or Transcatheter Bioprosthetic Valves: A Comprehensive Review.

Transcatheter aortic valve replacement (TAVR) has proven to be a safe, effective, and less invasive approach to aortic valve replacement in patients with aortic stenosis. In patients who underwent prior aortic valve replacement, transcatheter and surgical bioprosthetic valve dysfunction may occur as a result of structural deterioration or nonstructural causes such as prosthesis-patient mismatch (PPM) and paravalvular regurgitation. Valve-in-Valve (ViV) TAVR is a procedure that is being increasingly utilized for the replacement of failed transcatheter or surgical bioprosthetic aortic valves. Data regarding long-term outcomes are limited due to the recency of the procedure's approval, but available data regarding the short- and long-term outcomes of ViV TAVR are promising. Studies have shown a reduction in perioperative and 30-day mortality with ViV TAVR procedures compared to redo surgical repair of failed bioprosthetic aortic valves, but 1-year and 5-year mortality rates are more controversial and lack sufficient data. Despite the reduction in 30-day mortality, PPM and rates of coronary obstruction are higher in ViV TAVR as compared to both redo surgical valve repair and native TAVR procedures. New transcatheter heart valve designs and new procedural techniques have been developed to reduce the risk of PPM and coronary obstruction. Newer generation valves, new procedural techniques, and increased operator experience with ViV TAVR may improve patient outcomes; however, further studies are needed to better understand the safety, efficacy, and durability of ViV TAVR.

Clinical Outcomes Following Transcatheter Mitral Valve-in-Valve Replacement Using a Meril Myval Transcatheter Heart Valve

Transcatheter mitral valve-in-valve (TMViV) replacement for degenerated surgically implanted bioprosthetic valves has been described by both transseptal and transapical approaches. The balloon-expandable Myval transcatheter valve (Meril Life Science, Vapi, India) is commonly used for transcatheter valve-in-valve procedures in India. This study aimed to report in-hospital, 30-day, and 1-year outcomes of Myval patients who underwent TMViV in a single tertiary care centre in India. Symptomatic patients with surgical bioprosthetic mitral valve failure with New York Heart Association (NYHA) class III-IV symptoms, despite optimal medical therapy and high or very high risk for redo surgery, were assigned to TMViV following heart team discussions. Data were retrospectively collected and outcomes assessed. Twenty patients were treated, with mean age 64.4 years, 60% were female, and mean Society of Thoracic Surgeons (STS) predicted risk of operative mortality score was 8.1. The failure mechanism was combined stenosis and regurgitation in 60% of patients. Technical success was achieved in 100% of patients. The mean postprocedure and 30-day gradients were 4.6±2.7 and 6.3±2.1, respectively. None of them had significant valvular or paravalvular leaks or left ventricular outflow tract obstruction. All-cause mortality at 1 year was 10%, and all survivors were in New York Heart Association (NYHA) class I or II. TMViV replacement with a Meril Myval can be safely performed with high technical success, and low 30-day and 1-year mortality.

Thromboembolic and bleeding events after valvular intervention in patients with atrial fibrillation

AimTo assess outcomes after cardiac surgery with biological valve replacement, valve repair or transcatheter aortic valve implantation (TAVI) in patients with atrial fibrillation (AF) in accordance with oral anticoagulant (OAC)...

Abstract 14162: Long-Term Outcomes for Contemporary Mechanical versus Bioprosthetic Surgical Mitral Valve Replacement in Patients Aged 50 to 70 Years

Background: Guidelines are still unclear regarding whether mechanical or bioprosthetic valves should be selected for mitral valve replacement (MVR) in patients aged 50-70 years. Aims: To assess long-term outcomes in patients aged 50-70 years undergoing MVR using contemporary mechanical and bioprosthetic valves. Methods: We performed a retrospective study using the TriNetX global database to identify patients aged 50 to 70 years who had primary isolated surgical MVR from 2014 to 2020. Patients who had concomitant or prior cardiac surgeries were excluded. Patients were stratified into 2 groups: mechanical and bioprosthetic, and a 1:1 propensity-score matching to control for baseline differences between the two groups was performed. The primary endpoint was all-cause mortality and secondary endpoints were stroke, major bleeding, and reoperation over a follow-up period of 8 years. Results: Propensity-score matching yielded 1,130 patients in each group. There were significantly higher rates of all-cause mortality, stroke, and major bleeding events in the mechanical group compared to the bioprosthetic valve. There was no significant difference between the two groups regarding reoperation (Table 1 and Figure 1). Conclusion: At an 8-year follow-up, the use of contemporary bioprosthetic valves for MVR in patients aged 50-70 years shows favorable all-cause mortality and lower rates of strokes and major bleeding with similar reoperation rates compared to mechanical valves.

TCT-646 Percutaneous Tricuspid Valve-in-Valve Implantation in Failed Surgical Bioprosthetic Valves: Brazilian Single Center Registry

TCT-646 Percutaneous Tricuspid Valve-in-Valve Implantation in Failed Surgical Bioprosthetic Valves: Brazilian Single Center Registry

Antithrombotic therapy with Transcatheter aortic valve replacement.

Aortic valve replacement is a necessary management strategy for patients with severe aortic stenosis. The use of transaortic valve replacement (TAVR) has increased significantly over the last decade and now exceeds traditional surgical aortic valve replacement. Since the valve systems used in TAVR consist of bioprosthetic valve tissue encased in a metal stent frame, antithrombotic therapy recommendations cannot be extrapolated from prior data with differently constructed surgical bioprosthetic or mechanical valves. Data on the use of antithrombotic therapy with TAVR are a rapidly developing area of medicine. Choice of agents depends on several patient factors. Patients undergoing TAVR also have a relatively high incidence of subclinical valve thrombosis. The clinical impact of this phenomenon and the implications for antithrombotic therapy continue to evolve. It is critical for clinicians who treat patients undergoing TAVR to have a firm understanding of practice guidelines, the evolving evidence, and its implications for the use of antithrombotic therapy in these patients.

Procedural and one-year outcomes of the BASILICA technique in Europe: the multicentre EURO-BASILICA registry.

The real-world outcomes of the use of the BASILICA (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction) transcatheter technique in Europe have not been described. We sought to evaluate the procedural and one-year outcomes of BASILICA in patients at high risk for coronary artery obstruction (CAO) undergoing transcatheter aortic valve implantation (TAVI) in amulticentre European registry (EURO-BASILICA). Seventy-six patients undergoing BASILICA and TAVI at ten European centres were included. Eighty-five leaflets were identified as targets for BASILICA due to high risk for CAO. The updated Valve Academic Research Consortium 3 (VARC-3) definitions were used to determine prespecified endpoints of technical and procedural success and adverse events up to one year. Treated aortic valves included native (5.3%), surgical bioprosthetic (92.1%) and transcatheter valves (2.6%). Double BASILICA (for both left and right coronary cusps) was performed in 11.8% of patients. Technical success with BASILICA was achieved in 97.7% and resulted in freedom from any target leaflet-related CAO in 90.6% with alow rate of complete CAO (2.4%). Target leaflet-related CAO occurred significantly more often in older and stentless bioprosthetic valves and with higher implantation levels of transcatheter heart valves. Procedural success was 88.2%, and freedom from VARC-3-defined early safety endpoints was 79.0%. One-year survival was 84.2%; 90.5% of patients were in New York Heart Association Functional Class I/II. EURO-BASILICA is the first multicentre study evaluating the BASILICA technique in Europe. The technique appeared feasible and effective in preventing TAVI-induced CAO, and one-year clinical outcomes were favourable. The residual risk for CAO requires further study.

Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years - 1-year follow-up from the prospective INDURE registry.

We report 1-year safety and clinical outcomes in patients <60 years undergoing bioprosthetic surgical aortic valve intervention. The INSPIRIS RESILIA Durability Registry is a prospective, multicentre registry to assess clinical outcomes of patients <60 years. Patients with planned SAVR with or without concomitant replacement of the ascending aorta and/or coronary bypass surgery were included. Time-related valve safety, haemodynamic performance and quality of life (QoL) at 1 year were assessed. A total of 421 patients were documented with a mean age of 53.5 years, 76.5% being male and 27.2% in NYHA class III/IV. Outcomes within 30 days included cardiovascular-related mortality (0.7%), time-related valve safety (VARC-2; 5.8%), thromboembolic events (1.7%), valve-related life-threatening bleeding (VARC-2; 4.3%) and permanent pacemaker implantation (3.8%). QoL was significantly increased at 6 months and sustained at 1 year. Freedom from all-cause mortality at 1 year was 98.3% (95% confidence interval 97.1; 99.6) and 81.8% were NYHA I versus 21.9% at baseline. No patient developed structural valve deterioration stage 3 (VARC-3). The mean aortic pressure gradient was 12.6 mmHg at 1 year and the effective orifice area was 1.9 cm2. The 1-year data from the INSPIRIS RESILIA valve demonstrate good safety and excellent haemodynamic performance as well as an early QoL improvement. clinicaltrials.gov: NCT03666741.

11-Year Durability of a Perceval Sutureless Aortic Valve Implanted Inside a Hostile Calcified Homograft Root

Perceval valves are sutureless bioprosthetic surgical valves designed for the aortic position. The full breadth of indications for implanting Perceval valves is still unknown. Furthermore, the longer-term durability of the Perceval valve is also unclear. We report the long-term outcomes of a Perceval valve utilised for redo aortic valve replacement inside a heavily calcified homograft root in a patient with Klippel-Trenaunay-Weber syndrome.

Emergency Transcatheter Aortic Valve Implantation in a Surgical Aortic Bioprosthetic Valve for Acute Decompensated Heart Failure Caused by Sudden Progression of Structural Valve Deterioration.

Bioprosthetic aortic valves have limited durability. We herein report sudden progression of structural valve deterioration (SVD) and a successful case of emergency transcatheter aortic valve (TAV) implantation for acute decompensated heart failure (ADHF) caused by SVD. A 79-year-old man who had undergone a Bentall operation 11 years prior was diagnosed with ADHF due to suddenly progressive SVD. Emergency TAV implantation in the surgical bioprosthetic valve was selected based on the surgical risk. Ours and previous case reports suggest that SVD can progress suddenly, even after months of stability, and that emergency TAV implantation is effective.

Comparison of a novel self-expanding transcatheter heart valve with two established devices for treatment of degenerated surgical aortic bioprostheses

AimsThis study was performed to compare haemodynamic properties of a novel transcatheter heart valve (THV) with two established valve technologies for treatment of failing surgical aortic bioprosthetic valves (SAV). The ALLEGRA THV has been recently described with a proven safety and performance profile.Methods and resultsThe study was designed as a retrospective, single-centre study investigating 112 patients (77.7 ± 7.1 years, 53.8% female, STS score 6.8 ± 5.8% and logEuroSCORE I 27.4 ± 16.1%) with failing SAV. Patients were treated with the ALLEGRA THV (NVT, n = 24), the CoreValve/EvolutR (MTD, n = 64) or the Edwards Sapien/Sapien XT/Sapien 3 (EDW, n = 24). Adverse events, haemodynamic outcomes and patient safety were analysed according to VARC-3 definitions. Overall procedural success was high (94.6%), even though 58.9% of the treated SAV were classified as small (true inner diameter < 21 mm). After treatment, the mean pressure gradient was significantly reduced (baseline: 33.7 ± 16.5 mmHg, discharge: 18.0 ± 7.1 mmHg), with a corresponding increase in effective orifice area (EOA). The complication rates did not differ in between groups. There was a trend to lower mean transvalvular gradients after implantation of self-expanding THV with supra-annular valve function, despite a higher frequency of smaller SAVs in the NVT and MTD group. Additionally, comparison between NVT and MTD revealed statistically lower transvalvular gradients (NVT 14.9 ± 5.0 mmHg, MTD 18.7 ± 7.5 mmHg, p = 0.0295) in a subgroup analysis.ConclusionsValve-in-valve (ViV) treatment of failing SAV with supra-annular design like the ALLEGRA THV resulted in favourable haemodynamic outcomes with similar low clinical event rates and may therefore be an interesting alternative for VIV TAVI.Graphical abstract

Fusion Imaging–Guided BASILICA of a Stentless Bioprosthesis for Valve-in-Valve Transcatheter Aortic Valve Replacement

Fusion Imaging–Guided BASILICA of a Stentless Bioprosthesis for Valve-in-Valve Transcatheter Aortic Valve Replacement

Direct oral anticoagulants for atrial fibrillation in early postoperative valve repair or bioprosthetic replacement

ObjectiveDespite increased use of direct oral anticoagulants (DOACs), limited evidence guides their use in the early postoperative period after bioprosthetic valve implantation in patients with atrial fibrillation. Our objective was to describe the efficacy and safety of DOACs and warfarin in the first 3 months after surgical bioprosthetic valve replacement or repair in patients with atrial fibrillation. MethodsThis was a retrospective, registry-informed cohort study of surgical patients who underwent bioprosthetic valve replacement or repair, had concomitant atrial fibrillation and received oral anticoagulation at discharge. The primary efficacy outcome was a composite of death, ischemic stroke, transient ischemic attack, and systemic embolism; the primary safety outcome was a composite of major bleeding. Key secondary outcomes were comparative analyses of primary outcomes, temporal anticoagulation prescribing patterns, and 30-day readmission rates. ResultsA total of 1743 patients were included. Of the 570 patients in the DOAC group, 17 (2%) met the composite efficacy outcome and 55 (10%) met the composite safety outcome. Of the 1173 patients receiving warfarin, 41 (3%) and 114 (10%) met the composite efficacy and safety outcomes, respectively. Comparative secondary analysis was not statistically significant for either the efficacy (adjusted odds ratio, 0.85; 95% confidence interval, 0.46-1.55, P = .59) or safety (adjusted odds ratio, 0.94; 95% confidence interval, 0.66-1.34, P = .76) outcomes. The 30-day readmission rates were similar between both groups. ConclusionsOur results suggest DOACs may be safe and effective alternatives to warfarin in the early postoperative period after valve repair or surgical bioprosthetic replacement. Confirmation awaits adequately powered prospective studies.

Infective endocarditis of quadricuspid aortic valve

BackgroundInfective endocarditis of the aortic valve is a relatively common disease presentation, with surgical intervention a mainstay of treatment in severe cases. Quadricuspid aortic valves are a rare spontaneous developmental anomaly that are more likely to be asymptomatic, and less likely to require a full valve replacement than their hypocuspid counterparts. However, there is very little literature addressing infective endocarditis of this valve variant.Case presentationThis case report presents a case of infective endocarditis of a quadricuspid aortic valve that required replacement with a surgical bioprosthetic valve. The patient is a 30 year old male with a history of polysubstance use, upper extremity aneurysm, and prior tricuspid valve endocarditis. Surgical aortic valve replacement was performed with a 25 mm tissue valve via median sternotomy.ConclusionsThe patient made a full recovery after surgical aortic valve replacement and a course of antibiotics and was discharged home without any complications. This supports that surgical aortic valve replacement is feasible and safe in patients with polycuspid aortic valve endocarditis.