Comparison of Outcomes of Balloon-Expandable Versus Self-Expandable Transcatheter Heart Valves for Severe Aortic Stenosis.
Transcatheter aortic valve implantation (TAVI) is the treatment of choice for inoperable and high-risk patients with severe aortic stenosis. Our objectives were to elucidate potential differences in clinical outcomes and safety between balloon-expandable versus self-expandable transcatheter heart valves (THV). We performed a retrospective cohort study of all transfemoral TAVI procedures in Ontario, Canada, from 2007 to 2013. Patients were categorized into either balloon-expandable or self-expandable THV groups. The primary outcomes were 30-day and 1-year death, with secondary outcomes of all-cause readmission. Safety outcomes included bleeding, permanent pacemaker implantation, need for a second THV device, postprocedural paravalvular aortic regurgitation, stroke, vascular access complication, and intensive care unit length of stay. Inverse probability of treatment-weighted regression analyses using a propensity score were used to account for differences in baseline confounders. Our cohort consisted of 714 patients, of whom 397 received a self-expandable THV, whereas 317 had a balloon-expandable THV system. There were no differences in death or all-cause readmission. In terms of safety, the self-expandable group was associated with significantly higher rates of inhospital stroke (p value <0.05), need for a second THV device (5.3% vs 2.7%; p value = 0.013), and permanent pacemaker (22.6% vs 8.9%; p value <0.001), whereas the balloon-expandable group had more vascular access site complications (23.1% vs 16.7%; p value = 0.002). Thus, we found similar clinical outcomes of death or readmission for patients who underwent transfemoral TAVI with either balloon-expandable or self-expandable THV systems. However, there were important differences in their safety profiles.
Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences, Ontario, Canada. Electronic address: harindra.wijeysundera@sunnybrook.ca.
Harindra C
HC
Wijeysundera
Institute for Clinical Evaluative Sciences, Ontario, Canada.
Feng
F
Qiu
Institute for Clinical Evaluative Sciences, Ontario, Canada.
Maria
M
Koh
Institute for Clinical Evaluative Sciences, Ontario, Canada.
Treesa J
TJ
Prasad
Southlake Regional Health Centre, Newmarket, Ontario, Canada.
Warren J
WJ
Cantor
Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.
Asim
A
Cheema
Division of Cardiac Surgery, Department of Surgery, Western University, London, Ontario, Canada; Lawson Health Research Institute, Robarts Research Institute, London Health Sciences Centre, London, Ontario, Canada.
Michael W A
MW
Chu
Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences, Ontario, Canada.
Andrew
A
Czarnecki
University Health Network, Toronto, Ontario, Canada.
Christopher
C
Feindel
Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Ontario, Canada.
Stephen E
SE
Fremes
Cardiac Care Network of Ontario, Canada.
Kori J
KJ
Kingsbury
Division of Cardiology, Hamilton Health Sciences Centre, Hamilton, Ontario, Canada.
Madhu K
MK
Natarajan
Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.
Mark
M
Peterson
Ottawa Heart Institute, Ottawa, Ontario, Canada.
Marc
M
Ruel
Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Ontario, Canada.
Bradley
B
Strauss
Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences, Ontario, Canada.
Dennis T
DT
Ko
D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D009864:Ontario; D011183:Postoperative Complications; D011474:Prosthesis Design; D012042:Registries; D012189:Retrospective Studies; D015996:Survival Rate; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation*; D016896:Treatment Outcome