Comparative analysis of structural valve deterioration after bioprosthetic tricuspid valve replacement: Bovine pericardial versus porcine valves.

This study was conducted to compare the occurrence and the risk factors of structural valve deterioration (SVD) after bioprosthetic tricuspid valve replacement (TVR) between bovine pericardial valves and porcine valves. One-hundred and thirty-four TVR patients were enrolled; 108 patients underwent TVR with bovine pericardial bioprostheses (BTVR group) and 26 underwent TVR with porcine bioprostheses (PTVR group). The early results and long-term clinical outcomes were compared. The median follow-up duration was 90 (interquartile range: 33-135) months. Propensity score (PS) adjusted Cox regression and competing risk analyses were performed. The mean ages of the BTVR and PTVR groups were 62.2 ± 10.7 and 57.3 ± 13.9 years, respectively. The overall survival and cumulative incidence of cardiac death in the BTVR group were similar to those in the PTVR group (hazard ratio [95% confidence interval] = 1.399 [0.500-3.922] and 0.742 [0.249-2.212], respectively). SVD was significantly more frequent in the BTVR group (17.544 [1.070-243.902], P = .045). The tricuspid valve reoperation rate was significantly higher in the BTVR group (38.462 [2.591-476.190], P = .008). The cumulative incidence of SVD after bioprosthetic TVR was higher when using bovine pericardial valves than when using porcine valves.

Comparison of porcine versus bovine pericardial bioprosthesis in the mitral position.

BACKGROUND: There are no reports of midterm outcomes after mitral valve replacement with a 25-mm bioprosthesis in a large series of patients. This study aimed to examine perioperative and midterm outcomes of bioprosthetic valve choice, porcine or bovine pericardial, in the mitral position, focusing on 25-mm valves. METHODS: From 2007 to 2018, 467 patients received a mitral bioprosthesis, with or without concomitant procedures. Of these, 111 (23.8%) were porcine, and 356 (76.2%) were bovine pericardial, and 219 patients (46.9%) received a 25-mm valve. A propensity-matched cohort of 192 patients was used for outcome analyses. The influence of the valve type on midterm survival and incidence of cardiac death was assessed. Similarly, subanalysis stratified by valve size was conducted. RESULTS: In matched patients, there were no differences in midterm survival and incidence of cardiac death between the two groups (log-rank test; p = .268 and p = .097, respectively). There were no differences in midterm survival and incidence of cardiac death between the 25-mm valve and larger valve (log-rank test; p = .563 and p = .597, respectively). The Cox proportional-hazards model revealed that the valve type and 25-mm valve did not affect midterm survival (p = .487 and p = .375, respectively) and incidence of cardiac death (p = .678 and p = .562, respectively). CONCLUSIONS: The choice of a porcine or bovine pericardial bioprosthesis does not affect midterm survival and cardiac death. The 25-mm valves, whether bovine or porcine, could be an appropriate alternative when the patient's body size is small.

Early experience of implantation of the new CoreValve(®) Evolut(™) in degenerated bioprosthetic aortic valves.

Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis in high-risk patients. The PARTNER trial demonstrated equivalent 1-year survival rates between patients randomized to TAVI versus conventional surgery (Leon et al., N Engl J Med 2010;363:1597-1607), with sustained benefit up to 2 years (Makkar et al., NEJM 2012;366:1696-1704). Recently, the ADVANCE registry cited all-cause mortality rates of 4.5%, 12.8%, and 17.9% at 30-days, 6 months, and 1-year following TAVI in 1,015 high-risk patients (Linke, TCT 2012, 2012). In addition, TAVI was demonstrated to be a feasible treatment for severe native valve regurgitation in a series of 31 high-risk patients. The all-cause 30-day mortality rate was 6.4%, with a 30-day major stroke rate of 6.4%. At 1-year, the all-cause mortality rate was 12.5% (Roy et al., J Am Coll Cardiol 2012;60(17S):B264). We report the successful transcatheter implantation of the new CoreValve(®) Evolut(™) in two patients with regurgitant aortic bioprostheses.

Ten-Year Follow-Up of Mitral Valve Replacement with the Epic Porcine Valve in a Medicare Population.

BACKGROUND: Bioprosthetic surgical mitral valve replacement (SMVR) remains an important treatment option in the era of transcatheter valve interventions. We present 10-year clinical outcomes of Medicare beneficiaries undergoing SMVR with a contemporary low-profile mitral porcine valve. METHODS: This is a single-arm observational study using Medicare fee-for-service claims data. De-identified patients undergoing SMVR with the Epic™ Mitral valve (Abbott, Minnesota, USA) in the United States between 1/1/2008-12/31/2019 were selected by ICD-9/10 procedure codes and then linked to a manufacturer device tracking database. All-cause mortality, heart failure (HF) re-hospitalization, and mitral valve reintervention (surgical or transcatheter valve-in-valve) were evaluated at 10-years using the Kaplan Meier method. RESULTS: Among 75,739 Medicare beneficiaries undergoing SMVR during the study period, 14,015 were implanted with the Epic™ Mitral valve, of which 76.5% (10,720) had underlying HF. Mean age was 74±8 years. Survival at 10-years in patients without preoperative HF was 40.4% (95% CI 37.4%-43.4%) compared to 25.4% (95% CI 23.8%-27.0%) for patients with HF (p < 0.001). The 10-year freedom from HF rehospitalization was 51.3% (95% CI 49.4%-53.1%). Freedom from mitral valve reintervention was 91.4% (95% CI 89.7%-92.7%) at 10 years. CONCLUSIONS: This real-world nationwide study of Medicare beneficiaries receiving the Epic™ Mitral valve demonstrates >90% freedom from all-cause valve reintervention and >50% freedom from HF rehospitalization at 10-years post-implant. Long-term survival and HF rehospitalization in this population with mitral valve disease undergoing SMVR was found to be impacted by underlying HF.

Long-term clinical outcomes of tricuspid valve replacement using bovine versus porcine valves: a nationwide population-based study.

OBJECTIVES: The early and long-term clinical outcomes of bovine versus porcine tricuspid valve replacement (TVR) were compared based on the nationwide database from the National Health Insurance Service. METHODS: Of 1464 patients who underwent TVR from 2002 to 2018 in Korea, 541 were enrolled after excluding mechanical TVR, re-TVR, complex congenital heart disease, Ebstein anomaly and age <19 years at operation. Bovine (group B) and porcine valves (group P) were used in 342 and 199 patients, respectively. The median follow-up duration was 4.1 years [interquartile range 1.2-9.0]. Inverse probability of treatment weighting analysis was performed for adjustment between the groups. Early and long-term clinical outcomes, including all-cause mortality, ischaemic stroke, haemorrhagic stroke, endocarditis and reoperation, were compared. RESULTS: In inverse probability of treatment weighting analysis, operative mortality and early clinical outcomes were comparable between the groups. The cumulative incidence of all-cause mortality demonstrated no significant differences between the groups [36.8% vs 38.0% at 5 years in group B versus group P; adjusted hazard ratio = 0.93; P = 0.617]. The cumulative incidence of cardiac death, ischaemic stroke, haemorrhagic stroke and endocarditis also demonstrated no significant differences between the groups (28.1% vs 25.9%, 7.1% vs 1.2%, 3.2% vs 4.2% and 9.7% vs 6.0% at 5 years in group B versus group P, respectively). However, the cumulative incidence of reoperation was higher in group B than in group P (20.2% vs 3.4% at 5 years in group B vs group P; adjusted hazard ratio = 4.76; P = 0.006). CONCLUSIONS: Early clinical outcomes and long-term outcomes, including all-cause mortality, cardiac death, ischaemic stroke, haemorrhagic stroke and endocarditis, were comparable between bovine and porcine TVRs. However, porcine valves demonstrated a lower cumulative incidence of reoperation than bovine valves.

One-Year First-in-Human Success for VenoValve in Treating Patients With Severe Deep Venous Insufficiency.

OBJECTIVE: The clinical outcomes of this first-in-human (FIH) study provide safety and performance results 1 year after implantation of the VenoValve. BACKGROUND: Chronic venous insufficiency (CVI) is most often caused by valve failure in the venous system, which circulates blood from the lower limbs back to the heart and lungs. Severe diseases significantly influence quality of life, and current treatment options are limited. This study provides 1-year patient outcomes from 11 patients implanted with the VenoValve for treatment of severe deep venous CVI in C5 and C6 patients. Earlier results from 6-month follow-ups were previously published. METHODS: This prospective FIH study assessed the safety and performance of the VenoValve surgically implanted in 11 patients with C5 and C6 disease. All patients were followed up for at least 1 year. Assessments for adverse events, reflux time, disease severity, pain scores, and quality of life were reported. RESULTS: Implantation of VenoValve into the deep femoral vein was successful in all patients. Adverse events included 1 hematoma, 3 superficial wound infections, and 1 bleeding complication due to over-anticoagulation. One VenoValve became occluded due to patient non-compliance with anticoagulation medication. One-year clinical outcomes included significant decreases in mean reflux times (54%), and significant improvements in mean disease severity revised venous clinical severity score (56%), mean visual analog scale pain scores (76%), and Venous Insufficiency Epidemiologic and Economic Study QOL/sym scores. CONCLUSIONS: The promising results from this FIH study demonstrate sustained safety and effectiveness of the VenoValve at 1 year post-implantation, and support further study for its use as a novel treatment for severe, deep venous CVI caused by valvular incompetence. A pivotal, prospective, non-blinded, single-arm, multi-center study in the United States with seventy-five (75) patients is in progress to assess the safety and effectiveness of VenoValve in these patients through 30 days and 6 months. The clinical trial is registered on ClinicalTrials.gov under identifier: NCT04943172 (https://clinicaltrials.gov/ct2/show/NCT04943172?term=hancock+jaffe&draw=2&rank=1).

Ten-year outcomes of surgical aortic valve replacement with a contemporary supra-annular porcine valve in a Medicare population.

Objective: Bioprosthetic surgical aortic valve replacement remains an important treatment option in the era of transcatheter interventions. Real-world outcomes are not well characterized because of limited prospective follow-up studies. We present the 10-year clinical outcomes of Medicare beneficiaries undergoing surgical aortic valve replacement with a contemporary supra-annular porcine valve. Methods: This is a single-arm observational study using Medicare fee-for-service claims data. De-identified patients undergoing surgical aortic valve replacement with the Epic Supra valve (Abbott) in the United States between January 1, 2008, and December 31, 2019, were selected by International Classification of Diseases 9th and 10th Revision procedure codes and then linked to a manufacturer device tracking database. All-cause mortality, heart failure rehospitalization, and aortic valve reintervention (surgical or transcatheter valve-in-valve) were evaluated at 10 years using the Kaplan-Meier method. Results: Among 272,591 Medicare beneficiaries undergoing surgical aortic valve replacement during the study period, 11,685 received the Epic Supra valve, of whom 51.6% (6029) had underlying heart failure. Mean age was 76 ± 7 years. Survival at 10 years in patients without preoperative heart failure was 43.5% (95% confidence interval, 41.8-45.2) compared with 24.1% (95% confidence interval, 22.6-25.5) for patients with heart failure (P < .001). The 10-year freedom from heart failure rehospitalization was 64.0% (95% confidence interval, 62.6-65.3). Freedom from aortic valve reintervention was 94.6% (95% confidence interval, 93.8-95.3) at 10 years. Conclusions: This real-world nationwide study of US Medicare beneficiaries receiving the Epic Supra valve demonstrates more than 94% freedom from all-cause valve reintervention and 64% freedom from heart failure rehospitalization at 10 years postimplant. Long-term survival and heart failure rehospitalization in this population with aortic valve disease undergoing surgical aortic valve replacement were found to be impacted by underlying heart failure.

Long-term outcomes of right ventricle-to-pulmonary artery conduit insertion in adults with congenital heart disease: survival analysis by National Death Index.

OBJECTIVES: The aim of this study was to investigate the long-term outcomes following right ventricle-to-pulmonary artery (RV-to-PA) conduit insertion of Medtronic Freestyle® porcine valve (MFV) or pulmonary allograft valve (PAV) in adult patients with congenital heart disease. METHODS: Retrospective medical record review of consecutive RV-to-PA conduit insertion, using either PAV or MFV from 1991 to 2017. Perioperative data and clinic reports were collected. Cause and date of death were obtained from the Australian National Death Index to obtain survival function. RESULTS: In total, 232 patients (median age 31.5 years, interquartile range 25-41 years) underwent RV-to-PA conduit insertion (PAV = 84 and MFV = 148) and were eligible for inclusion [63.8% tetralogy of Fallot (TOF); 11.6% congenital pulmonary stenosis (PS); 24.6% other diagnoses]. The overall median follow-up time was 9.1 years (interquartile range 5.3-12.6 years). The mean gradient was 11.8 ± 7.1 mmHg in PAV and 16.6 ± 9.6 mmHg in MFV patients. Congenital PS patients had 100% survival at 20 years, TOF patients at 5, 10, 15 and 20 years had 99%, 97%, 96% and 96% survival, respectively. Patients with other primary diagnoses at 5, 10, 15 and 20 years had 93%, 91%, 87% and 87% respectively. Freedom from reintervention did not differ significantly at 5 and 10 years between pulmonary allograft (98.6%, 98.6%) and Freestyle® porcine bioprosthesis (97.5%, 93%). CONCLUSIONS: Both valves perform equally well with regard to patients' freedom from reoperation, although transvalvular gradient was higher for Freestyle® patients. Congenital PS and TOF patients had better survival than patients with other primary diagnoses.

Possible Link Between the ABO Blood Group of Bioprosthesis Recipients and Specific Types of Structural Degeneration.

Background Pigs/bovines share common antigens with humans: α-Gal, present in all pigs/bovines close to the human B-antigen; and AH-histo-blood-group antigen, identical to human AH-antigen and present only in some animals. We investigate the possible impact of patients' ABO blood group on bioprosthesis structural valve degeneration (SVD) through calcification/pannus/tears/perforations for patients ≤60 years at implantation. Methods and Results This was a single-center study (Paris, France) that included all degenerative bioprostheses explanted between 1985 and 1998, mostly porcine bioprostheses (Carpentier-Edwards second/third porcine bioprostheses) and some bovine bioprostheses. For the period 1998 to 2014, only porcine bioprostheses with longevity ≥13 years were included (total follow-up ≥29 years). Except for blood groups, important predictive factors for SVD were prospectively collected (age at implantation/longevity/number/site/sex/SVD types) and analyzed using logistic regression. All variables were available for 500 explanted porcine bioprostheses. By multivariate analyses, the A group was associated with an increased risk of: tears (odds ratio[OR], 1.61; P=0.026); pannus (OR, 1.5; P=0.054), pannus with tears (OR, 1.73; P=0.037), and tendency for lower risk of: calcifications (OR, 0.63; P=0.087) or isolated calcification (OR, 0.67; P=0.17). A-antigen was associated with lower risk of perforations (OR 0.56; P=0.087). B-group patients had an increased risk of: perforations (OR, 1.73; P=0.043); having a pannus that was calcified (OR, 3.0, P=0.025). B-antigen was associated with a propensity for calcifications in general (OR, 1.34; P=0.25). Conclusions Patient's ABO blood group is associated with specific SVD types. We hypothesize that carbohydrate antigens, which may or may not be common to patient and animal bioprosthetic tissue, will determine a patient's specific immunoreactivity with respect to xenograft tissue and thus bioprosthesis outcome in terms of SVD.