Objective: The objective of this study was to compare short-and midterm clinical and echocardiographic outcomes according to the use of pledgeted sutures during aortic valve replacement. Methods:... Show moreObjective: The objective of this study was to compare short-and midterm clinical and echocardiographic outcomes according to the use of pledgeted sutures during aortic valve replacement. Methods: Patients with aortic stenosis or regurgitation requiring aortic valve replacement were enrolled in a prospective cohort study to evaluate the safety of a new stented bioprosthesis. Outcomes were analyzed according to the use of pledgets (pledgeted group) or no pledgets (nonpledgeted group). The primary outcome was a composite of thromboembolism, endocarditis, and major paravalvular leak at 5 years of follow-up. Secondary outcomes included multiple clinical end-points and hemodynamic outcomes. Propensity score matching was performed to adjust for prognostic factors, and subanalyses with small valve sizes (< 23 mm) and suturing techniques were performed. Results: The pledgeted group comprised 640 patients (59%), and the nonpledgeted group 442 (41%), with baseline discrepancies in demographic characteristics, comorbidities, and stenosis severity. There were no differences between groups in any outcome. After propensity score matching, the primary outcome occurred in 41 (11.7%) patients in the pledgeted and 36 (9.8%) in the nonpledgeted group (P = .51). The effective orifice area was smaller in the pledgeted group (P = .045), whereas no difference was observed for the mean or peak pressure gradient. Separate subanalyses with small valve sizes and suturing techniques did not show relevant differences. Conclusions: In this large propensity score-matched cohort, comprehensive clinical outcomes were comparable between patients who underwent aortic valve replacement with pledgeted and nonpledgeted sutures up to 5 years of follow-up, but pledgets might lead to a slightly smaller effective orifice area in the long run. Show less
ObjectiveThe objective of this study was to compare short- and midterm clinical and echocardiographic outcomes according to the use of pledgeted sutures during aortic valve replacement... Show moreObjectiveThe objective of this study was to compare short- and midterm clinical and echocardiographic outcomes according to the use of pledgeted sutures during aortic valve replacement.MethodsPatients with aortic stenosis or regurgitation requiring aortic valve replacement were enrolled in a prospective cohort study to evaluate the safety of a new stented bioprosthesis. Outcomes were analyzed according to the use of pledgets (pledgeted group) or no pledgets (nonpledgeted group). The primary outcome was a composite of thromboembolism, endocarditis, and major paravalvular leak at 5 years of follow-up. Secondary outcomes included multiple clinical endpoints and hemodynamic outcomes. Propensity score matching was performed to adjust for prognostic factors, and subanalyses with small valve sizes (<23 mm) and suturing techniques were performed.ResultsThe pledgeted group comprised 640 patients (59%), and the nonpledgeted group 442 (41%), with baseline discrepancies in demographic characteristics, comorbidities, and stenosis severity. There were no differences between groups in any outcome. After propensity score matching, the primary outcome occurred in 41 (11.7%) patients in the pledgeted and 36 (9.8%) in the nonpledgeted group (P = .51). The effective orifice area was smaller in the pledgeted group (P = .045), whereas no difference was observed for the mean or peak pressure gradient. Separate subanalyses with small valve sizes and suturing techniques did not show relevant differences.ConclusionsIn this large propensity score-matched cohort, comprehensive clinical outcomes were comparable between patients who underwent aortic valve replacement with pledgeted and nonpledgeted sutures up to 5 years of follow-up, but pledgets might lead to a slightly smaller effective orifice area in the long run. Show less
Eugene, M.; Duchnowski, P.; Prendergast, B.; Wendler, O.; Laroche, C.; Monin, J.L.; ... ; EORP VHD II Registry Investigators 2021
BACKGROUND There were gaps between guidelines and practice when surgery was the only treatment for aortic stenosis (AS). OBJECTIVES This study analyzed the decision to intervene in patients with... Show moreBACKGROUND There were gaps between guidelines and practice when surgery was the only treatment for aortic stenosis (AS). OBJECTIVES This study analyzed the decision to intervene in patients with severe AS in the EORP VHD (EURObservational Research Programme Valvular Heart Disease) II survey. METHODS Among 2,152 patients with severe AS, 1,271 patients with high-gradient AS who were symptomatic fulfilled a Class I recommendation for intervention according to the 2012 European Society of Cardiology guidelines; the primary end point was the decision for intervention. RESULTS A decision not to intervene was taken in 262 patients (20.6%). In multivariate analysis, the decision not to intervene was associated with older age (odds ratio [OR]: 1.34 per 10-year increase; 95% CI: 1.11 to 1.61; P = 0.002), New York Heart Association functional classes I and II versus III (OR: 1.63; 95% CI: 1.16 to 2.30; P = 0.005), higher age adjusted Charlson comorbidity index (OR: 1.09 per 1-point increase; 95% CI: 1.01 to 1.17; P = 0.03), and a lower transaortic mean gradient (OR: 0.81 per 10-mm Hg decrease; 95% CI: 0.71 to 0.92; P < 0.001). During the study period, 346 patients (40.2%, median age 84 years, median EuroSCORE II [European System for Cardiac Operative Risk Evaluation II] 3.1%) underwent transcatheter intervention and 515 (59.8%, median age 69 years, median EuroSCORE II 1.5%) underwent surgery. A decision not to intervene versus intervention was associated with lower 6-month survival (87.4%; 95% CI: 82.0 to 91.3 vs 94.6%; 95% CI: 92.8 to 95.9; P < 0.001). CONCLUSIONS A decision not to intervene was taken in 1 in 5 patients with severe symptomatic AS despite a Class I recommendation for intervention and the decision was particularly associated with older age and combined comorbidities. Transcatheter intervention was extensively used in octogenarians. (J Am Coll Cardiol 2021;78:2131-2143) (c) 2021 by the American College of Cardiology Foundation. Show less
AIMS The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for... Show moreAIMS The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.METHODS AND RESULTS Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing & nbsp;definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs.CONCLUSIONS Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies. Show less
Objective: Several recent-generation surgical tissue valves have been found to have bleeding rates exceeding rates recommended by regulatory bodies. We explored bleeding events using data from the... Show moreObjective: Several recent-generation surgical tissue valves have been found to have bleeding rates exceeding rates recommended by regulatory bodies. We explored bleeding events using data from the Pericardial Surgical Aortic Valve Replacement (PERIGON) Pivotal Trial for the Avalus valve (Medtronic, Minneapolis, Minn) to examine whether this end point remains relevant for the evaluation of bioprostheses.Methods: Patients (n = 1115) underwent aortic valve replacement. Bleeding and thromboembolic event episodes in patients within 3 years postimplant were analyzed for frequency, timing, and severity, focusing on patients taking antiplatelet/anticoagulant medications at the time of the event. Clinical and hemodynamic outcomes are also reported.Results: At 3 years, the Kaplan-Meier cumulative probability estimate of all-cause death was 7.2% (cardiac, 3.6%; valve-related, 1.1%). The Kaplan-Meier cumulative probability estimates of all and major hemorrhage were 8.7% and 5.2%, respectively. Ninety-nine bleeding events occurred in 86 patients: most occurred >30 days postsurgery. Among the 51 late major bleeds, in 5 cases the patients were taking anticoagulant/antiplatelet medication for prophylaxis after surgical aortic valve replacement at the time of the event, whereas the remaining patients were taking medications for other reasons. Age (hazard ratio, 1.035; 95% confidence interval, 1.004-1.068), peripheral vascular disease (hazard ratio, 2.135; 95% confidence interval, 1.106-4.122), renal dysfunction (hazard ratio, 1.920; 95% confidence interval, 1.055-3.494), and antithrombotic medication use at the time of the event (hazard ratio, 1.417; 95% confidence interval, 1.048-1.915) were associated with late bleeds (major and minor).Conclusions: Overall clinical outcomes demonstrated low mortality and few complications except for major bleeding. Most bleeding events occurred >30 days after surgery and in patients taking antiplatelet and/or anticoagulation for indications other than postimplant prophylaxis. Show less
Objectives: The study objectives were to evaluate the safety, efficacy, and hemodynamic performance of a novel stented bovine pericardial aortic valve bioprosthesis 2 years after implantation... Show moreObjectives: The study objectives were to evaluate the safety, efficacy, and hemodynamic performance of a novel stented bovine pericardial aortic valve bioprosthesis 2 years after implantation.Methods: The PERIcardial SurGical AOrtic Valve ReplacemeNT Pivotal Trial enrolled patients with symptomatic moderate/severe aortic stenosis or regurgitation at centers in Canada, Europe, and the United States. We report the outcomes and hemodynamic performance in patients with up to 2 years of follow-up.Results: A total of 1273 patients were enrolled, and 1110 underwent implantation. Among patients undergoing implantation, the mean age was 70.2 +/- 8.9 years; 833 (75.0%) were male. Risk of mortality (Society of Thoracic Surgeons) was 2.0% +/- 1.4%. At the time of analysis, 604 patients had completed the 2-year follow-up visit. Linearized late event rates were as follows: all death, 2.68%; valve-related death, 0.42%; valve thrombosis, 0.05%; endocarditis, 0.94%; thromboembolism, 1.68%; all hemorrhage, 2.94%; major hemorrhage, 1.99%; all paravalvular leak, 0.26%; and major paravalvular leak, 0.05% per patient-year. Mean 2-year aortic gradient and effective orifice area were 13.4 +/- 5.0 mm Hg and 1.5 +/- 0.37 cm(2), respectively. Moderate and severe prosthesis-patient mismatch were observed in 43.5% and 34.8% of patients at 2 years, respectively. Improvement in New York Heart Association class compared with baseline was observed in 73.0% with moderate mismatch and 74.1% with severe mismatch.Conclusions: The Avalus (Medtronic, Minneapolis, Minn) bovine pericardial valve demonstrates good clinical and safety outcomes at 2 years. Hemodynamic performance shows mean gradients comparable to currently available bovine pericardial aortic valves. There was no clinical impact of moderate to severe mismatch at 2 years. Further follow-up is required to evaluate midterm to long-term clinical outcome. Show less
