7-Year outcomes after surgical aortic valve replacement with a stented bovine pericardial bioprosthesis in over 1100 patients: a prospective multicenter analysis.

Objectives: Safety, efficacy, and durability are important considerations when selecting a bioprosthesis for aortic valve replacement (AVR). This study assessed 7-year clinical outcomes and haemodynamic performance of the Avalus bioprosthesis.

Methods: Patients indicated for surgical AVR were enrolled in this prospective, nonrandomized trial, conducted across 39 sites globally.

Current definitions of hemodynamic structural valve deterioration after bioprosthetic aortic valve replacement lack consistency.

Objective: New echocardiographic definitions have been proposed for hemodynamic structural valve deterioration. We aimed to study their consistency in classifying structural valve deterioration after surgical aortic valve replacement.

Methods: Data were used of patients undergoing surgical aortic valve replacement in a multicenter, prospective cohort study with a 5-year follow-up.

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

Objectives: 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.

Methods: Echocardiograms were assessed by a single core laboratory.

The robustness of the flow-gradient classification of severe aortic stenosis.

Objectives: A flow-gradient classification is used to determine the indication for intervention for patients with severe aortic stenosis (AS) with discordant echocardiographic parameters. We investigated the agreement in flow-gradient classification by stroke volume (SV) measurement at the left ventricular outflow tract (LVOT) and at the left ventricle.

Methods: Data were used from a prospective cohort study and patients with severe AS (aortic valve area index ≤0.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Antithrombin Supplementation in Patients at Risk for Antithrombin Deficiency After Cardiac Surgery.

Background: Antithrombin (AT) activity is reduced during cardiac operations with cardiopulmonary bypass (CPB), which is associated with adverse outcomes. Preoperative AT supplementation, to achieve >58% and <100% AT activity, may potentially reduce postoperative morbidity and mortality in cardiac operations with CPB. This prospective, multicenter, randomized, double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of preoperative treatment with AT supplementation in patients at risk for low AT activity after undergoing cardiac surgery with CPB.

Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes.

Objectives: This analysis evaluated the safety, durability and haemodynamic performance of a stented bovine pericardial valve through 5 years of follow-up in patients with an indication for surgical aortic valve replacement.

Methods: Kaplan-Meier analysis was used to estimate the incidence of survival and valve-related thromboembolism, major paravalvular leak, endocarditis, structural valve deterioration (SVD) and reintervention. The mean aortic gradient and New York Heart Association (NYHA) functional class were also evaluated.

Outcomes of Surgical Bioprosthetic Aortic Valve Replacement in Patients Aged ≤65 and >65 Years.

Background: Implantation of a bioprosthetic valve is a reasonable choice for patients aged > 65 years. For middle-aged patients there is less certainty about whether a mechanical or bioprosthetic valve is best.

Methods: The Pericardial Surgical Aortic Valve Replacement (PERIGON) Pivotal Trial is evaluating the safety and efficacy of the Avalus bioprosthesis (Medtronic).

Retrospective Analysis of Thromboelastography-Directed Transfusion in Isolated CABG: Impact on Blood Product Use, Cost, and Outcomes.

Cardiac surgeries account for approximately 20% of blood use in the United States. Allogeneic transfusion has been associated with increased risk of morbidity and mortality, further justifying the need to reduce blood use. This study aimed at determining whether a point-of-care coagulation test, thromboelastography (TEG), impacted blood product administration and outcomes.

Minimally invasive triple valve surgery: A single center experience.

Objective: Minimally invasive surgery is a widely accepted surgical treatment for valve disease, however triple valve surgery (TVS) is a complex and challenging procedure. The objective of this study was to describe the morbidity and mortality related to minimally invasive TVS at our institution.

Methods: This was a retrospective review of all minimally invasive TVS performed between 2012 and 2019.

Sizing Strategy and Implant Considerations for the Avalus Valve.

Hemodynamic performance of the Avalus valve through 3 years after implant is comparable to that of contemporary surgical bioprostheses. Many variables affect hemodynamic outcomes, including surgical technique. This article describes our experience with the Avalus bioprosthesis and strategies to achieve optimal hemodynamic performance.

Antithrombotic therapy and bleeding events after aortic valve replacement with a novel bioprosthesis.

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 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.

An in vitro comparison of internally versus externally mounted leaflets in surgical aortic bioprostheses.

Objectives: To improve haemodynamic performance, design modifications of prosthetic valves have been proposed with each new generation of valves. These different designs also impact the amount of mechanical wear, because mechanical stresses are distributed differently. Because long-term evidence for new prosthetic valves is lacking, this in vitro study compared hydrodynamic performance and durability among 3 currently available bioprosthetic valves with internally (IMLV) or externally mounted leaflets (EMLV).

Safety, efficacy, and hemodynamic performance of a stented bovine pericardial aortic valve bioprosthesis: Two-year analysis.

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.

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.

Thrombelastography-Directed Transfusion in Cardiac Surgery: Impact on Postoperative Outcomes.

Background: Transfusion of allogenic blood products is associated with substantial morbidity and increased risk of mortality. Thrombelastography (TEG) to direct transfusion management during and immediately after cardiothoracic surgery reduced blood product usage in our institution. The goal of this study was to quantify the impact of TEG on postoperative outcomes.

Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes.

Objectives: We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience.

Methods: From June 2013 to January 2015, 300 patients (mean age 76.7 ± 7.

One-year outcomes associated with a novel stented bovine pericardial aortic bioprosthesis.

Objectives: The study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovine pericardial aortic valve.

Methods: This trial enrolled patients with symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. We assessed death, valve-related adverse events, functional recovery, and hemodynamic performance at discharge, 3 to 6 months, and 1 year, as required by the US Food and Drug Administration for regulatory approval.

TEG-Directed Transfusion in Complex Cardiac Surgery: Impact on Blood Product Usage.

Complex cardiac procedures often require blood transfusion because of surgical bleeding or coagulopathy. Thrombelastography (TEG) was introduced in our institution to direct transfusion management in cardiothoracic surgery. The goal of this study was to quantify the effect of TEG on transfusion rates peri- and postoperatively.

Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis.

Objectives: We assessed the safety, effectiveness and haemodynamic performance of a new bovine stented aortic valve bioprosthesis (Avalus™).

Methods: The PERIGON Pivotal Trial is a prospective, non-randomized, multicentre study. Subjects had symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation.

Minimally Invasive Mitral Valve Surgery II: Surgical Technique and Postoperative Management.

Techniques for minimally invasive mitral valve repair and replacement continue to evolve. This expert opinion, the second of a 3-part series, outlines current best practices for nonrobotic, minimally invasive mitral valve procedures, and for postoperative care after minimally invasive mitral valve surgery.

Current era minimally invasive aortic valve replacement: techniques and practice.

Background: Since the first aortic valve replacement through a right thoracotomy was reported in 1993, upper hemisternotomy and right anterior thoracotomy have become the predominant approaches for minimally invasive aortic valve replacement. Clinical studies have documented equivalent operative mortality, less bleeding, and reduced intensive care/hospital stay compared with conventional sternotomy despite longer procedure times. However, comparative trials face challenges due to patient preference, surgeon bias, and the lack of a standardized minimally invasive surgical approach.