One-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation.

Background: The CLASP IID (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical) trial is the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive risk patients with significant symptomatic degenerative mitral regurgitation (DMR).

Objectives: The study sought to report primary and secondary endpoints and 1-year outcomes for the full cohort of the CLASP IID trial.

Methods: Prohibitive-risk patients with 3+/4+ DMR were randomized 2:1 (PASCAL:MitraClip).

Transcatheter Aortic Valve Replacement Outcomes in End-Stage Renal Disease Patients on Hemodialysis Requiring Midodrine.

Background: Patients with dialysis-dependent end-stage renal disease (ESRD) taking midodrine may be at high risk for poor outcomes following transcatheter aortic valve replacement (TAVR). We evaluated dialysis-dependent ESRD patients taking midodrine.

Methods: We conducted a retrospective analysis of non-clinical trial TAVR patients from February 2012 to December 2020 from 11 facilities in a Western US health system.

Left Atrial to Coronary Sinus Shunting for Treatment of Symptomatic Heart Failure.

Background: Heart failure (HF) is associated with both mortality and a significant decline in health status. Interatrial shunting is increasingly being investigated as a novel therapeutic option.

Objectives: The ALT FLOW Early Feasibility Study was designed to evaluate the safety of the Edwards left atrial to coronary sinus APTURE Transcatheter Shunt System in patients with symptomatic HF.

Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.

Background: Severe symptomatic degenerative mitral regurgitation (DMR) has a poor prognosis in the absence of treatment, and new transcatheter options are emerging.

Objectives: The CLASP IID (Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial) randomized trial (NCT03706833) is the first to evaluate the safety and effectiveness of the PASCAL system compared with the MitraClip system in patients with significant symptomatic DMR. This report presents the primary safety and effectiveness endpoints for the trial.

Clinical Factors and Outcomes When Real-World Heart Teams Overruled STS Risk Scores in TAVR Cases.

Objectives: This study was conducted to determine why heart teams recommended transcatheter aortic valve replacement (TAVR) versus surgical AVR (SAVR) for patients at low predicted risk of mortality (PROM) and describe outcomes of these cases.

Background: Historically, referral to TAVR was based predominately on the Society of Thoracic Surgeons (STS) risk model's PROM >3%. In selected cases, heart teams had latitude to overrule these scores.

Comparison of 26-mm Evolut and 23-mm Sapien 3 Valves in TAVR for Small Aortic Annulus.

Background: Patients with small aortic annuli (SAA) are prone to higher post-transcatheter aortic valve replacement (TAVR) transvalvular gradients and development of prosthesis-patient mismatch (PPM). In many patients with SAA, the choice of TAVR valve commonly involves choosing between the 26-mm Medtronic Evolut 2 (ME26) or the 23-mm Edwards Sapien 3 valve (ES23). We compared echocardiographic and clinical outcomes in patients with SAA undergoing TAVR with either valve.

Transcatheter Closure of Large Atrial Septal Defects in Adults.

Objective: To examine the outcomes of percutaneous closure of large atrial septal defects (ASDs) (≥25 mm).

Background: Data on long-term results after closure of large ASDs are limited.

Methods: We reviewed the records of 275 consecutive patients who underwent transcatheter closure of large (≥25 mm) ASDs from January 1999 until December 2016 in our center.

Transcatheter edge-to-edge repair of the tricuspid valve: The US experience.

Objectives: To examine the trends in utilization and outcomes of tricuspid valve (TV) transcatheter edge-to-edge repair (TEER).

Background: Surgery for isolated tricuspid regurgitation is associated with high morbidity and mortality and is rarely performed. TV TEER is an attractive alternative.

Outcomes of transcatheter versus surgical aortic valve replacement among solid organ transplant recipients.

Background: There is a paucity of data regarding the outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) among solid-organ transplant recipients.

Methods: Temporal trends in hospitalizations for aortic valve replacement among solid-organ transplant recipients were determined using the National Inpatient Sample database years 2012-2017. Propensity matching was conducted to compare admissions who underwent TAVR versus SAVR.

Post-Market Clinical Follow-Up With the Patent Foramen Ovale Closure Device IrisFIT (Lifetech) in Patients With Stroke, Transient Ischemic Attack, or Other Thromboembolic Events.

Background: A patent foramen ovale (PFO) has been associated with embolic strokes and transient ischemic attacks (TIAs). Catheter closure of PFO is effective in preventing recurrent events. Residual shunts and procedure or device related complications can occur, including atrial fibrillation and thrombus formation.

Permanent Pacemaker Lead Insertion Connected to an External Pacemaker Generator for Temporary Pacing After Transcatheter Aortic Valve Implantation.

Background: Outcomes after transcatheter aortic valve implantation (TAVI) have been demonstrated to be at least equivalent in the short term compared to surgical valve implantation (SAVI). However, Conduction abnormalities are more common after TAVI than SAVI and the need for permanent pacemaker implantation is more common after TAVI with the currently commercially available self-expanding valves than after SAVI. Temporary pacemaker implantation may be associated with inability to ambulate, lead migration or perforation and infection.

Trends in Characteristics and Outcomes of Patients Undergoing Coronary Revascularization in the United States, 2003-2016.

Importance: Data on the contemporary changes in risk profile and outcomes of patients undergoing percutaneous coronary intervention (PCI) or coronary bypass grafting (CABG) are limited.

Objective: To assess the contemporary trends in the characteristics and outcomes of patients undergoing PCI or CABG in the United States.

Design, Setting, And Participants: This retrospective cohort study used a national inpatient claims-based database to identify patients undergoing PCI or CABG from January 1, 2003, to December 31, 2016.

Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve.

Objectives: The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli.

Background: Favorable 30-day outcomes of S3 TAVR in annuli >683 mm have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak.