Transcatheter Mitral Valve Replacement With Atrial Fixation for Treatment of Atrial Functional Mitral Regurgitation
- PMID: 40109243
- DOI: 10.1161/CIRCINTERVENTIONS.124.014985
Transcatheter Mitral Valve Replacement With Atrial Fixation for Treatment of Atrial Functional Mitral Regurgitation
Abstract
Background: Many patients with atrial functional mitral regurgitation are not suitable candidates for surgery or transcatheter repair. For transcatheter mitral valve replacement, a common contraindication is the risk of left ventricular outflow tract obstruction, particularly in patients with atrial functional mitral regurgitation, who have characteristically small left ventricles. Herein, we examine the outcomes of transcatheter mitral valve replacement using the AltaValve system, which employs atrial fixation thus minimizing left ventricular outflow tract obstruction risk.
Methods: Patients with severe, symptomatic mitral regurgitation who were treated in the AltaValve early feasibility study or on the basis of a compassionate use exemption. The definition of atrial functional mitral regurgitation required the presence of: (1) severe mitral regurgitation; (2) atrial fibrillation; (3) normal left ventricular size; (4) left ventricular ejection fraction ≥50%; and (5) absence of organic mitral disease. Procedural outcomes, 30-day survival, and echo findings are reported.
Results: Fourteen patients (71% women, mean age 77.9 years, Society of Thoracic Surgeons Predicted Risk of Mortality score 5.4%) were treated, including 11 via transseptal delivery and 3 via a transapical approach. Technical success and mitral regurgitation reduction from severe to none/trace were achieved in all cases. There were no cases of left ventricular outflow tract obstruction. All-cause mortality at 30 days was 14% (2/14). Class III/IV New York Heart Association status was reduced from 79% at baseline to 0% at 30 days. At 30 days, 11 of 12 surviving patients had an available echocardiogram; mitral regurgitation severity was trace/none in 90.9% (10/11) and mild in 9.1% (1/11).
Conclusions: The AltaValve system shows promising early procedural and clinical results for the unique anatomy of patients with atrial functional mitral regurgitation. Long-term clinical studies to demonstrate the benefit of this system are warranted.
Keywords: cardiac valves; heart valve prosthesis implantation; mitral valve; stroke volume.
Conflict of interest statement
Dr Saxon is a proctor for Edwards Lifesciences, Medtronic, Inc, and Abbott Vascular, and has received consulting fees from Edwards Lifesciences, Medtronic, Inc, Johnson & Johnson, and W.L. Gore. Dr Genereux is a consultant and advisor for Abbott Vascular and receives honorarium from Abbott Vascular; consulting fees from Abiomed and serves on the advisory board for Abiomed; consulting fees from Boston Scientific; consulting fees from Cardiovascular Systems, Inc; consulting fees, honorarium, and advisory board for Edwards Lifesciences; proctor for Edwards Lifesciences; research funding support from Edwards Lifesciences; consulting fees from GE Healthcare, iRhythm Technologies, Medtronic, Inc, OpSens, and 4C Medical; consulting fees and equity from Pi-Cardia, Puzzle Medical, Saranas, and Soundbite Medical; consulting fees and honoraria from Shockwave; consulting fees from Siemens and Teleflex; principal investigator for the AltaValve Early Feasibility study; and consulting fees and advisory board for egnite, Inc. Dr Adam has received honoraria from Abbott Vascular, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic, Inc. Dr Nickenig has received research funding and honoraria from Abbott Vascular, Edwards Lifesciences, and Medtronic, Inc. Dr Kaneko is on the advisory board for Edwards Lifesciences, Abbott Vascular, and Johnson & Johnson, and serves as a consultant for Medtronic, Inc. Dr Sorajja is on the advisory board for Anteris; has received consulting fees from Boston Scientific, Edwards Lifesciences, Evolution Medical, Medtronic, Inc, Shifamed, TriFlo, and W.L. Gore; and served as principal investigator for HighLife Medical and Abbott Vascular. The other authors report no conflicts.
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