Surgical Bioprosthetic Valves Research Articles

Numerical models of valve-in-valve implantation: effect of intentional leaflet laceration on the anchorage.

Transcatheter aortic valve implantation (TAVI) is currently recommended in practice guidelines for patients who are at intermediate to high surgical risk for surgical aortic valve replacement. Coronary artery obstruction is a fatal complication of TAVI that occurs in up to 3.5% of the implantations inside a failed surgical bioprosthetic valve (valve-in-valve, ViV). A new technique to address this problem is intentional laceration of the bioprosthetic leaflets, known as BASILICA. In this technique, the leaflets are lacerated to prevent coronary obstruction and may also help in preventing leaflet thrombosis. Our hypothesis is that this technique may harm the circumferential stress in the surgical valve and weaken the anchorage of the TAVI device. This study aims to compare the anchorage post-ViV implantations, with and without lacerations, using numerical modelling. Deployments of TAVI stents (Medtronic Evolut PRO; Edwards SAPIEN 3) inside an externally mounted surgical bioprosthetic valve (Sorin Mitroflow) were modelled by finite element analysis. The results show that each laceration reduces the contact area of the TAVI stent with its landing zone and that the anchorage contact force weakens. The BASILICA technique has lesser effect on the anchorage contact area and forces in the SAPIEN than in the Evolut cases, because the balloon inflation is less sensitive to the deployment region. TAVI stent migration was not found in any of the models. These results can help expanding the use of leaflet laceration by choosing a better matched TAVI devices for the BASILICA technique.

Trends, characteristics, in-hospital outcomes and mortality in surgical mitral valve replacement among patients with and without COPD in Spain (2001-2015).

PurposeWe examined trends, characteristics and in-hospital outcomes in mechanical and bioprosthetic surgical mitral valve replacement (SMVR) among patients with and without chronic obstructive pulmonary disease (COPD) in Spain from 2001 to 2015. We also identified factors associated with in-hospital mortality (IHM) in both groups of patients according to the implanted valve type.MethodsWe analyzed data from the Spanish National Hospital Discharge Database for patients aged 40 years or over. We selected admissions of patients whose medical procedures included SMVR. We grouped hospitalizations by COPD status.ResultsOver 43,024 patients identified, 83.63% underwent mechanical mitral valve replacement and 16.37% bioprosthetic valve (6.71% and 7.78% with COPD, respectively). The incidence of SMVR decreased for mechanical valves and increased for bioprosthetic valves over time in both groups of patients. The incidence of SMVR admissions was lower among COPD patients than in those without COPD, both for mechanical and bioprosthetic valves. IHM decreased significantly over time, regardless of the type of valve, in both groups of patients. COPD was associated with a significant increase in IHM, but only among patients who underwent bioprosthetic SMVR (OR 1.32, 95% CI 1.01–1.73).ConclusionsThe incidence of mechanical SMVR decreased while that of bioprosthetic SMVR increased over time in both groups of patients. COPD patients were less surgically operated than non-COPD patients for both valve types. In COPD patients, bioprosthetic SMVR was proportionally more used than mechanical SMVR. Mortality decreased over time for both valve types in patients with and without COPD. COPD increased in-hospital mortality among patients undergoing a biological SMVR.

Anticoagulation with Vitamin K Antagonists Versus Antiplatelet Therapy After Surgical Bioprosthetic Valve Implantation in the Prevention of Thromboembolism: A Meta-Analysis of Randomized Controlled Trials

BACKGROUND: The optimum medical therapy in the first three months after surgical bioprosthetic valve implantation (BVI) remains controversial. Current guidelines of the American College of Cardiology recommend either anticoagulation with vitamin K antagonists (VKA) (level IIa) or antiplatelet (AP) using aspirin (level IIa) after surgery, which is based on non-randomized studies. Hence, we performed a meta-analysis of randomized controlled trials (RCT) comparing the efficacy and safety of VKA vs AP therapy early after surgical BVI. METHODS: An extensive search of PubMed, Medline, Cochrane and Ovid was performed for RCTs comparing VKA vs AP therapy among adult patients who underwent surgical BVI. Outcome measures for thromboembolism, all-cause mortality and major bleeding were extracted and analyzed using a random effect model via Review Manager V5.3. RESULTS: Three RCTs with 590 patients were included. There were no differences in the rates of thromboembolic events (5% vs 6.8%; p=0.37) or all-cause mortality (4.7% vs 5.8% p=0.64) between the VKA vs AP groups There was a higher incidence of major bleeding in the VKA group (6% vs 2.4%), which was statistically significant (OR 2.63 (95% CI 1.08–6.43; p=0.03)). CONCLUSION: Vitamin K antagonist and AP therapies have similar rates of thromboembolic events and all-cause mortality in the first three months among patients post-surgical BVI. However, VKAs have a significantly higher incidence of major bleeding, which suggests that AP therapy may be the preferable strategy for anticoagulation in BVI post-surgery. KEYWORDS: Prosthetic heart valve, Anticoagulation, Antiplatelet therapy, Bioprosthetic Valve Implantation

Transcatheter aortic valve replacement

Aortic stenosis (AS) is caused by progressive calficiation of the valve and is the most common cause of left ventricular outflow tract obstruction. Once moderate AS is present, there is a high liklihood of progression to severe AS. Surgical aortic valve replacement has been the standard treatment for patients with severe symptomatic AS. Previously, patients determined to be at high risk for surgery could only be offered diuretics and balloon valvuloplasty which served as palliative treatment and had no effect on long-term outcomes. The development of transcatheter aortic valve replacement (TAVR) has emerged as a lifeline for patients considered to be inoperable providing both improvement in symptoms and statistically significant mortality benefit.The concept of transcatheter balloon expandable valves was first introduced in the 1980s by a Danish researcher by the name of H. R. Anderson who began testing this idea on pigs. In 2002, Dr. Alain Cribier performed the first successful percutaneous aortic valve replacement on an inoperable patient. The first approval of TAVR for the indication of severe AS in prohibitive risk patients came in 2011. In 2012, the FDA approved TAVR in patients at high surgical risk. In 2015 the indication was expanded to include “valve-in-valve” procedure for failed surgical bioprosthetic valves. In 2016 the FDA approved TAVR valves for use in patients with severe AS at intermediate risk. Following the results of the PARTNER-3 trial published in 2019, the FDA further expanded the indication for TAVR valves to include low risk patients.

Impact of type 2 diabetes mellitus in the utilization and in-hospital outcomes of surgical mitral valve replacement in Spain (2001\u20132015)

BackgroundThe main aims of this study were to examine the incidence and in-hospital outcomes of mechanical and bioprosthetic surgical mitral valve replacement (SMVR) among patients with and without T2DM.MethodsWe performed a retrospective study using the Spanish National Hospital Discharge Database from 2001 to 2015. We included patients with SMVR codified in their discharge report. We grouped admissions by diabetes status. Propensity score matching (PSM) was used to compare outcomes of isolated SMVR.ResultsWe identified 42,937 patients (16.41% with T2DM). Incidence rates of mechanical and bioprosthetic SMVR were higher among T2DM patients than among non-T2DM patients. In both groups of patients, the use of bioprosthetic SMVR increased over time. The use of mechanical valves remained stable among T2DM patients. In T2DM and non-T2DM patients with mechanical SMVR, in hospital mortality (IHM) and MACCE decreased significantly (p < 0.001) from 2001 to 2015. T2DM patients had an overall 11.37% IHM, compared with 10.76% among non-T2DM patients (p = 0.176). Regarding MACCE figures were 14.72% vs. 14.22% (p = 0.320) after mechanical SMVR. Total crude IHM were 14.29% for T2DM patients and 15.13% for those without T2DM with bioprosthetic SMVR (p = 0.165) and 18.22 vs. 19.64%, for a MACCE (p = 0.185). Using PSM we found that the IHM and the MACCE of isolated SMVR did not differ significantly between patients with or without T2DM beside the type of valve replacement. Among T2DM patients, those who received bioprosthetic valves had higher IHM (14.29% vs. 11.37%; p = 0.003) and a higher rate of MACCE (18.22% vs. 14.72%; p = 0.001) than T2DM patients with mechanical SMVR.ConclusionsIn Spain from 2001 to 2015, the incidence rates of hospitalization to undergo mechanical or bioprosthetic SMVR were higher among the population suffering T2DM than among the non-T2DM population. In both groups of patients the use of bioprosthetic SMVR increased over time and the use of mechanical valves remained stable in T2DM. T2DM patients have IHM and MACCE after mechanical and bioprosthetic SMVR which are not significantly different to those found among non-diabetic patients. Among T2DM patients, the crude IHM was significantly higher in those who received a bioprosthetic SMVR than those with mechanical SMVR.

Aortic Migration of a Self-expanding Transcatheter Heart Valve During Intended Bioprosthetic Valve Fracture

Valve-in-Valve Transcatheter aortic valve replacement (VIV TAVR) for treatment of failed bioprosthetic surgical valves has been shown to be a safe and effective alternative to reoperation for patie...

Transcatheter aortic valve-in-valve implantation for failed surgical bioprosthetic valves. A minimalist approach without contrast aortography or echocardiographic guidance.

To demonstrate safety, feasibility and short-term clinical outcomes after transcatheter aortic valve-in-valve (ViV) implantation under local anesthesia without contrast aortography or echocardiographic guidance. Transcatheter ViV implantation is an emerging treatment modality for patients with degenerative surgical bioprostheses. Given the radiopaque properties of the surgical aortic valve (SAV) frame, ViV procedures can often be performed with fluoroscopic guidance alone. ViV implantation was performed in 37 patients with SAV failure under local anesthesia without contrast aortography. Clinical and echocardiographic data were obtained at baseline, discharge, and 30 days. Mean age was 74 ± 10 years and STS predicted risk of mortality was 5.6 ± 2.4%. Mean transaortic gradient decreased from 39.4 ± 15.5 mmHg to 13 ± 6.3 mmHg at discharge (p < .001), and 20 ± 7.5 mmHg at 30 days (p < .001 compared to baseline), aortic valve area increased from 0.9 ± 0.3 cm2 to 1.2 ± 0.4 cm2 at 30 days (p = .007). No patient had more than mild aortic regurgitation. Hospital discharge occurred at a median of 2.6 ± 4.4 days. At 30-day follow-up there were no deaths, myocardial infarctions, strokes, repeat hospital admissions for heart failure, or renal failure. One patient (2.7%) required a new pacemaker. 93% of the patients were in New York Heart Association functional class I or II. Transcatheter aortic ViV implantation for selected patients with degenerative surgical bioprostheses under local anesthesia without aortography or echocardiographic guidance is feasible and safe.

Determinants of Bioprosthetic Aortic Valve Degeneration

ObjectivesThe aim of the present long-term study was to assess the incidence and mode of valve hemodynamic deterioration (VHD) of bioprosthetic aortic valves, as well as associated factors. BackgroundModern definitions of bioprosthetic valve deterioration recommend the use of echocardiography for the assessment of transprosthetic gradients and valvular regurgitation. MethodsA total of 466 consecutive patients (mean age 73.5 ± 7.5 years, 56.0% women) underwent surgical bioprosthetic aortic valve replacement between 1994 and 2014. Clinical assessment, transthoracic echocardiography, and laboratory testing were performed at baseline and follow-up. VHD was defined as mean transprosthetic gradient ≥30 mm Hg and/or at least moderate valvular regurgitation on echocardiography. Patient-prosthesis mismatch was defined as an effective orifice area indexed to body surface area ≤0.8 cm2/m2. ResultsPatients were followed for a median of 112.3 months (interquartile range: 57.7 to 147.7 months). Among patients with complete follow-up (n = 383), 70 subjects (18.3%; 4.8% per valve-year) developed VHD after a median of 32.4 months (interquartile range: 12.9 to 87.2 months; stenosis, n = 45; regurgitation, n = 16; both, n = 9). Factors associated with VHD by multivariate regression analysis were serum creatinine >2.1 mg/dl (hazard ratio [HR]: 4.143; 95% confidence interval [CI]: 1.740 to 9.866; p = 0.001), porcine tissue valves (HR: 2.241; 95% CI: 1.356 to 3.706; p = 0.002), arterial hypertension (HR: 3.022; 95% CI: 1.424 to 6.410; p = 0.004), and patient-prosthesis mismatch (HR: 1.931; 95% CI: 1.102 to 3.384; p = 0.022). By Kaplan-Meier analysis, elderly subjects showed faster development of VHD (age <70 years, 133.5 months [95% CI: 116.2 to 150.8 months]; 70 to 80 years, 129.1 months [95% CI: 112.4 to 145.7 months]; >80 years, 100.3 months [95% CI: 63.6 to 136.9 months]; p = 0.023). By multivariate Cox regression, age, diabetes, concomitant coronary artery bypass grafting, creatinine, and VHD (p < 0.05) were significantly associated with mortality. ConclusionsOn the basis of echocardiography, every fifth patient developed VHD after surgical bioprosthetic heart valve replacement. VHD was associated with renal impairment, the use of porcine tissue valves, arterial hypertension, and patient-prosthesis mismatch. Patients younger than 70 years were not affected by faster VHD.

A Durable Porcine Pericardial Surgical Bioprosthetic Heart Valve: a Proof of Concept

Bioprosthetic leaflets made from animal tissues are used in the majority of surgical and transcatheter cardiac valve replacements. This study develops a new surgical bioprosthesis, using porcine pericardial leaflets. Porcine pericardium was obtained from genetically engineered pigs with a mutation in the GGTA-1 gene (GTKO) and fixed in 0.6% glutaraldehyde, and used to develop a new surgical valve design. The valves underwent in vitro hydrodynamic test in a pulse duplicator and high-cycled accelerated wear testing and were evaluated for acute haemodynamics and thrombogenicity in a juvenile sheep implant study for 48 h. The porcine surgical pericardial heart valves (pSPHVs) exhibited excellent hydrodynamics and reached 200 million cycles of in vitro durability, with no observable damage. Juvenile sheep implants demonstrated normal valve function with no acute thrombogenic response for either material. The pSPHV incorporates a minimalistic construction method using a tissue-to-tissue design to cover the stent. This new design is a proof of concept alternative to the use of bovine pericardium and synthetic fabric in surgical bioprosthetic heart valves.

75-Year-Old Man With Chest Pain and Dyspnea

75-Year-Old Man With Chest Pain and Dyspnea

Transcatheter Aortic Valve-in-Valve Implantation For Failed Surgical Bioprosthetic Valves. A Minimalist Approach Without Contrast Aortography or Echocardiographic Guidance

Transcatheter Aortic Valve-in-Valve Implantation For Failed Surgical Bioprosthetic Valves. A Minimalist Approach Without Contrast Aortography or Echocardiographic Guidance

Valve durability after transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure to treat severe symptomatic aortic stenosis. While the TAVI procedure can be performed safely and provide excellent 5-year results, little is known about long-term durability. TAVI valves are composed of bioprosthetic leaflets are prone to deterioration, which are categorized as structural valve deterioration (SVD) and non-SVD. SVD refers to an intrinsic pathology of the leaflets or stent structure with mechanisms that include leaflet calcification, leaflet tear, stent fracture, or stent creep. Non-SVD processes include valve thrombosis, infective endocarditis and patient prosthesis mismatch. TAVI valves degenerate by similar mechanisms as bioprosthetic surgical aortic valves. Unique mechanisms that contribute to TAVI degeneration include valve crimpling, balloon expansion, stent under-expansion and valve thrombosis. The absence of a universally accepted definition of SVD poses a challenge in estimating valve durability. Traditional surgical bioprosthetic aortic valves have demonstrated excellent durability with clinically relevant SVD of 6.6% at 10-year follow up. Long-term durability of TAVI valves, however, remain poorly defined. From meta-analysis TAVI trials, SVD was estimated at 7% at 5 years. With iterative improvements in TAVI valve construction and deployment techniques, long-term durability may improve. Until long-term outcomes are better understood, TAVI should be used with caution in younger patients.

Transcatheter Mitral Valve Replacement in Patients With Previous Aortic Valve Replacement.

Transcatheter mitral valve replacement (TMVR) may mature to become a therapeutic option for high-risk patients with severe mitral regurgitation (MR), particularly in patients at high or prohibitive surgical risk. MR patients with preexisting aortic valve prosthesis have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the TMVR anchoring mechanism and the aortic prosthesis. We describe the procedural and short-term outcomes of transapical TMVR with the Tiara valve in patients experiencing severe symptomatic MR with previous aortic valve replacement (AVR). Twelve consecutive high surgical risk patients (11 men; mean age, 75±6 years) with aortic valve prosthesis and severe MR underwent TMVR with Tiara valve. Aortic valves were mechanical in 5 and biological in 7 patients, while 1 patient had previously undergone implantation of a transcatheter valve within a failed bioprosthetic surgical valve. Six patients (50%) had undergone redo surgical aortic valve replacement. Clinical characteristics of the group include prior mitral valve repair in 2, prior coronary bypass grafting surgery in 5, chronic atrial fibrillation in 7, renal failure in 9, and pacemaker/cardiac resynchronization device in 9 patients. Mean Society of Thoracic Surgery score and EuroSCORE II were 10.5±4.4 and 12.4±3.7, respectively. Mean baseline left ventricular ejection fraction was 35.5±5.3% (range, 30%-45%). The Tiara valve was implanted uneventfully in all patients. Device migration or left ventricular outflow tract obstruction was not observed. No patient required conversion to open heart surgery or periprocedural hemodynamic support. Procedural success was 100% with no death, MI, stroke, major bleeding, or access site complications at 30 days. MR was eliminated in all 12 patients immediately after implantation. Transapical mitral valve replacement with the Tiara valve in high-risk patients with severe MR and aortic valve prostheses is technically feasible and can be performed safely.

Invited Commentary

Invited Commentary

Correction to: Transcatheter valve-in-valve implantation (VinV-TAVR) for failed surgical aortic bioprosthetic valves.

Unfortunately, an error occurred in the original article.

Is Bioprosthetic Valve Fracture Beneficial for Patients with Larger Surgical Valves Undergoing Valve in Valve TAVR?

This review aims to summarize data regarding bioprosthetic valve fracture (BVF), a novel technique that involves fracturing the surgical valve sewing ring to allow for further expansion of the transcatheter heart valve in patients undergoing valve in valve transcatheter aortic valve replacement (VIV TAVR). Bench testing and clinical experience have demonstrated that most, but not all, bioprosthetic surgical valves can be fractured. BVF in patients with small- and intermediate-sized surgical valves results in a lower residual valve gradient and larger final valve effective orifice area as compared with standard VIV TAVR. However, whether patients with larger bioprothetic valves benefit from BVF, and whether the hemodynamic benefits of BVF translate into improved clinical outcomes, is unknown. BVF improves the hemodynamic results of VIV TAVR in small surgical valves. However, further research is needed to determine whether BVF is beneficial for patients with larger surgical valves, and whether the hemodynamic benefits of BVF result in improved clinical outcomes.

P6300Transcatheter and surgical aortic bioprosthetic valve leaflet thrombosis defined by computed tomography is associated with cerebrovascular events: contemporary meta-analysis of 8 observational studies

P6300Transcatheter and surgical aortic bioprosthetic valve leaflet thrombosis defined by computed tomography is associated with cerebrovascular events: contemporary meta-analysis of 8 observational studies

Transcatheter valve-in-valve implantation (VinV-TAVR) for failed surgical aortic bioprosthetic valves

We sought to investigate the procedural and hemodynamic outcome after valve-in-valve transcatheter aortic valve replacement (VinV-TAVR) for different surgical (SBV) and transcatheter (TAVR) bioprosthetic valves. 223 patients (76 ± 11years, STS-Score 8.3 ± 10.1) suffering from SBV failure treated with VinV-TAVR were enrolled at 6 centers across Germany. At time of the intervention, the majority of patients were in NYHA-class ≥ III (88%, n = 180). Failure mode of the SBVs was either stenosis, regurgitation (AR) or a combination of both in 85 (38%), 76 (34%) and 62 (28%) patients, respectively. 138 (62%) patients were treated with first generation TAVR valves (Edwards Sapien XT or CoreValve). Second generation valves were implanted in 85 (38%) patients (Sapien 3, Medtronic CoreValve Evolut, SJM-Portico, JenaValve). VinV-TAVR was associated with high procedural success rate, conversion to surgery was necessary in 3 (2%) patients. After VinV-TAVR procedure, 4 (2%) patients suffered from ≥ moderate AR. In 6 (3%) patients a second valve was implanted due to mispositioning of the first valve and subsequent severe paravalvular AR. Coronary obstruction was observed in 4 (2%) patients. Major bleeding and cerebrovascular complications (according to VARC) were reported in 3 (1%) and 4 (2%) patients at 30days. Post-interventionally, 44/178 (25%) patients evidenced a mean pressure gradient (mPG) ≥ 20mmHg. Residual stenosis was not associated with increased mortality (HR 0.39; 95% CI 0.13-1.22; p = 0.11). In VinV-TAVR for SBV-failure is a safe procedure resulting in hemodynamic improvement in the majority of patients. Residual stenosis is a common finding which can be observed in 1/4 of patients undergoing VinV-TAVR. However, this condition is not associated with increased 1-year-mortality.

Contemporary outcomes of isolated bioprothestic mitral valve replacement for mitral regurgitation

BackgroundEarly experience with transcatheter mitral valve replacement (TMVR) highlighted several investigational challenges related to this novel therapy. Conclusive randomised clinical trials in the field may, therefore, be years ahead. In...

Antithrombotic Management of Patients With Prosthetic Heart Valves.

Valvular heart disease is a major public health issue. The prevalence of valvular heart disease is expected to increase due to an aging population. Valve dysfunction manifests as valve stenosis, regurgitation, or both due to various etiologies. Valve repair and replacement are the main treatment options for severe valve dysfunction. Valve replacement is achieved by using either a mechanical or a bioprosthetic valve. Mechanical valves are more durable but require lifelong anticoagulation with associated complications. Bioprosthetic valves usually require anticoagulation only transiently after implantation but are less durable and degenerate more rapidly. In this article, we discuss antithrombotic regimens in persons after valve operations. We discuss general issues and antithrombotic recommendations for patients undergoing surgical bioprosthetic valve replacement, mechanical valve replacement (including different regimens for different positions and types of mechanical valves), mitral valve repair, and transcatheter aortic valve replacement. In addition, we discuss the antithrombotic management of patients in special circumstances, including patients with mechanical valves who have recurrent bleeding or thrombotic events, patients with mechanical valves undergoing surgery, and pregnant women with mechanical valves.