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PARTNER 2: TAVR improves 3-year outcomes in bioprosthetic aortic valve degeneration
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Patients with bioprosthetic aortic valve failure who underwent transcatheter aortic valve replacement had sustained improved hemodynamic status, favorable survival and excellent quality of life and functional outcomes at 3 years, according to a study published in the Journal of the American College of Cardiology.
Bioprosthesis dysfunction
John G. Webb, MD, director of interventional cardiology at St. Paul’s Hospital in Vancouver and professor in the division of cardiology at the University of British Columbia, and colleagues analyzed data from 365 patients (mean age, 79 years; 64% men) from the PARTNER 2 trial who had symptomatic severe dysfunction of a bioprosthesis who were eligible for valve-in-valve treatment with a transcatheter heart valve (Sapien XT, Edwards Lifesciences).
Patients underwent clinical assessments at baseline, discharge, 30 days, 1 year, 2 years and 3 years. Echocardiograms were also performed at 3-year follow-up.
The primary endpoint was all-cause mortality at 3 years. Secondary endpoints were stroke, cardiac mortality, major vascular complications, aortic valve reintervention, new permanent pacemaker, acute kidney injury, MI, hemodynamic valve deterioration and clinical alleviation of symptoms.
The overall Kaplan-Meier estimate at 3 years was 32.7% for mortality and 1.9% for repeat aortic valve replacement.
The mean transaortic gradient was 35 mm Hg at baseline, 17.8 mm Hg at 30 days and 16.6 mm Hg at 3 years. Effective orifice area increased from 0.93 cm2 at baseline to 1.13 cm2 at 30 days and 1.15 cm2 at 3 years.
Moderate to severe aortic regurgitation decreased from 45.1% before TAVR to 2.5% at 3 years. Decreases were also seen in moderate or severe mitral regurgitation (33.7% vs. 8.6%; P < .0001) and tricuspid regurgitation (29.7% vs. 18.8%; P = .002).
Left ventricular ejection fraction increased from 50.7% at baseline to 54.7% at 3 years (P < .0001). LV mass index decreased from baseline to 3 years (136.4 g/m2 to 109.1 g/m2; P < .0001).
The percentage of patients with NYHA class III or IV improved from 90.4% at baseline to 14.1% at 3 years (P < .0001). Other improvements were seen in Kansas City Cardiomyopathy Questionnaire overall scores from baseline to 3 years (43.1 to 73.1; P < .0001).
“The early improvements associated with [valve-in-valve] TAVR are maintained through 3 years, supporting the value of [valve-in-valve] TAVR as an important alternative therapy in appropriate patients with aortic bioprosthetic valve failure,” Webb and colleagues wrote.
Future research
“Longer-term follow-up beyond 3 years is still required to assess durability following [valve-in-valve] TAVR, which perhaps will not be obtained in the current cohort,” Stephan Windecker, MD, director and chief physician in the department of cardiology at the Swiss Cardiovascular Center in Bern, Switzerland, and co-director of clinical research at Bern University Hospital, and colleagues wrote in a related editorial. “It is unlikely we will have a randomized trial that compares re-do surgery with [valve-in-valve] TAVR; rather the procedure will gradually become standard of care by default unless new adverse data become available.” – by Darlene Dobkowski
Disclosures: The PARTNER 2 trial was sponsored by Edwards Lifesciences. Webb reports he is a consultant for Edwards Lifesciences and is a member of the PARTNER trial executive committee. Windecker reports he has received research, educational and training grants from Abbott, Amgen, Bayer, Biotronik, Boston Scientific, Bristol-Myers Squibb, Edwards Lifesciences, Medtronic, St. Jude and Terumo. Please see the study and editorial for all other authors’ relevant financial disclosures.
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