Intrepid TMVR Early Feasibility Study 30-Day Results
- Early feasibility study of the Intrepid TMVR Transfemoral System reports favorable outcomes at 30-day follow-up, including absence of mortality, stroke, reintervention, or new pacemaker along with excellent valve function, and no significant paravalvar leak.
- Appropriate anticoagulation regimen post-TMVR needs careful study, as more conservative anticoagulation regimens may result in similar favorable clinical outcomes without the added risk of bleeding events.
- Given the small number of patients and early timepoint studied, larger trials and longer follow-up are indicated to evaluate this valve and assess whether elimination of MR transforms into reversal of left ventricular remodeling.
What are the outcomes of transcatheter mitral valve replacement (TMVR) with transfemoral access in patients at prohibitive or high surgical risk?
The investigators conducted a prospective, multicenter, nonrandomized early feasibility study to evaluate safety and performance of the Intrepid valve using transfemoral/transseptal access in patients with moderate-severe/severe, symptomatic mitral regurgitation (MR) at high surgical risk. Candidacy was determined by heart teams with approval by a central screening committee. Echocardiographic data were evaluated by an independent core laboratory. Clinical events were adjudicated by a clinical events committee. Data are reported as medians (Q1, Q3) or mean ± standard deviation, unless otherwise noted. Adverse events are reported as Kaplan-Meier estimates where appropriate.
Fifteen patients were enrolled at six sites from February 2020–May 2021. Median age was 80 years and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) was 4.7%; 87% were male and 53% had prior sternotomy. Fourteen implants were successful. One patient converted to surgery during the index procedure. Patients stayed a median 5 days post-procedure. There were six (40%) access site bleeds and 11 (73%) iatrogenic atrial septal defect closures. At 30 days, there were no deaths, strokes, or reinterventions. All implanted patients had trace/no valvar or paravalvar MR and mean gradient was 4.7 ± 1.8 mm Hg.
The authors concluded that the 30-day results from the Intrepid transfemoral TMVR early feasibility study demonstrate excellent valve function and no mortality or stroke.
This early feasibility study of the Intrepid TMVR Transfemoral System reports favorable outcomes at 30-day follow-up, including absence of mortality, stroke, reintervention, or new pacemaker along with excellent valve function, and no significant paravalvar leak. Future advances in technology and reduction in sheath size may result in fewer bleeding complications, and conservative anticoagulation regimens compared to current regimens may result in similar favorable clinical outcomes without the added risk of bleeding events. Finally, these preliminary findings must be taken in the context of the small number of patients and early timepoint studied, and larger trials and longer follow-up are indicated to evaluate this valve and assess whether elimination of MR transforms into reversal of left ventricular remodeling.
Clinical Topics: Anticoagulation Management, Cardiac Surgery, Cardiovascular Care Team, Congenital Heart Disease and Pediatric Cardiology, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Valvular Heart Disease, Cardiac Surgery and Arrhythmias, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Imaging, CHD and Pediatrics and Interventions, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound, Mitral Regurgitation
Keywords: Anticoagulants, Cardiac Surgical Procedures, Echocardiography, Geriatrics, Heart Septal Defects, Atrial, Heart Valve Diseases, Mitral Valve Insufficiency, Pacemaker, Artificial, Secondary Prevention, Sternotomy, Stroke, TCT21, Transcatheter Cardiovascular Therapeutics, Ventricular Remodeling
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