Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue.

Objective: Novel tissue leaflets (RESILIA tissue) may improve durability of bioprosthetic heart valves. The COMMENCE trial is an ongoing prospective study to evaluate valve replacement using RESILIA tissue. This report describes mid-term outcomes in the mitral cohort of COMMENCE.

Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis.

Objective: As bioprosthetic aortic valve replacement (AVR) extends to younger cohorts, tissue durability is of paramount importance. We report 7-year outcomes from an AVR bioprosthesis utilizing novel tissue.

Methods: This was an international investigational device exemption trial for novel AVR with annual follow-up and a subset re-consented at 5 years for extended 10-year follow-up.

Does valve size impact hemodynamic, left ventricular mass regression, and prosthetic valve deterioration with a sutureless aortic valve?

Objective: To assess the mid-term clinical outcomes, hemodynamics, left ventricular (LV) mass regression, and structural valve deterioration (SVD) in patients implanted with the Perceval aortic sutureless valve across valve sizes.

Methods: Data were obtained from a multicenter European trial and a US Investigational Device Exemption trial. Echocardiography data were analyzed by an echocardiography core lab.

Five-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement With RESILIA Tissue.

Background: The COMMENCE trial was conducted to evaluate the safety and effectiveness of aortic valve replacement using a bioprosthesis with novel RESILIA tissue (Edwards Lifesciences). RESILIA tissue is incorporated in the INSPIRIS RESILIA aortic valve (Edwards Lifesciences).

Methods: Patients underwent clinically indicated surgical aortic valve replacement with a bovine pericardial bioprosthesis (model 11000A; Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), US Food and Drug Administration Investigational Device Exemption trial.

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.

Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial.

Background: Patients with heart failure (HF) and symptomatic secondary mitral regurgitation (SMR) have a poor prognosis, with morbidity and mortality directly correlated with MR severity. Correction of isolated SMR with surgery is not well established in this population, and medical management remains the preferred approach in most patients. The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial was designed to determine whether transcatheter mitral valve (MV) repair with the MitraClip device is safe and effective in patients with symptomatic HF and clinically significant SMR.

The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue.

Objectives: The COMMENCE trial was conducted to evaluate the safety and effectiveness of a novel bioprosthetic tissue for surgical aortic valve replacement (AVR).

Methods: Patients underwent clinically indicated surgical AVR with the Carpentier-Edwards PERIMOUNT™ Magna Ease™ aortic valve with RESILIA™ tissue (Model 11000A) in a prospective, multinational, multicentre (n = 27), single-arm, FDA Investigational Device Exemption trial. Events were adjudicated by an independent Clinical Events Committee; echocardiograms were analysed by an independent Core Laboratory.

The ABLATE Trial: Safety and Efficacy of Cox Maze-IV Using a Bipolar Radiofrequency Ablation System.

Background: The Cox Maze-IV procedure (CMP-IV) has replaced the Cox Maze-III procedure as the most common approach for the surgical treatment of atrial fibrillation (AF). The Food and Drug Administration-regulated AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation (ABLATE) trial sought to demonstrate the safety and efficacy of the CMP-IV performed with the Synergy ablation system (AtriCure, Inc, Cincinnati, OH).

Methods: Fifty-five patients (aged 70.

A single-center experience with the Sorin Mitroflow pericardial aortic valve: hemodynamics up to five years.

Background And Aim Of The Study: The authors' institution participated in a 28-center FDA Investigational Device Exemption study to evaluate the Sorin Mitroflow pericardial aortic bioprosthesis. Six high-enrolling sites evaluated patients on an annual basis as part of an ongoing hemodynamic study. These data represent patients followed for an average of five years after implant, with annual echocardiography.

Simple amiodarone protocol reduces postoperative atrial fibrillation.

Background: : Incorporating amiodarone into an existing postoperative atrial fibrillation (AF) prevention pathway may reduce postoperative AF and length of stay (LOS).

Methods: : From July 2002 through December 2002, 476 consecutive cardiac surgical patients were managed with an AF prevention protocol using aggressive potassium replacement, intraoperative/postoperative magnesium supplementation, and postoperative resumption of β-blockers. From January 2003 through June 2003, 592 additional patients were subjected to the same protocol except amiodarone was initiated intraoperatively (150 mg intravenously) and continued postoperatively until discharge (200 mg orally three times daily).

Influence of endoscopic versus traditional saphenectomy on event-free survival: five-year follow-up of a prospective randomized trial.

Background: Endoscopic harvesting of the greater saphenous vein is increasingly used during cardiac surgery to improve patient satisfaction and reduce the wound complications associated with traditional open techniques. Although histologic studies suggest no significant difference in vein quality between these two techniques, long-term follow-up is lacking to address whether graft patency and event-free survival are influenced by the harvest method.

Methods: A total of 112 isolated coronary artery bypass patients were prospectively randomized to have veins harvested using either an endoscopic (n = 54) or traditional (n = 58) technique.