Balloon Predilation in Transcatheter Aortic Valve Replacement with Self-expanding Valves

ABSTRACT

Introduction: The utility of routine balloon predilation in transcatheter aortic valve replacement (TAVR) with self-expanding valves is not established. Clinical outcomes at 30 days and 1 year post TAVR, deploying the “no balloon predilation” strategy have not been systematically described.

Methods: Between October 2011 and September 2016, all patients who underwent TAVR with self-expanding valves (CoreValve®, Medtronic, Inc., Minneapolis, MN, USA) were stratified into predilation and no predilation groups. Of the 564 patients in the study, predilation was performed in 410 (72.7%) patients.

Results: The need for postdilation was less when predilation was performed (30.2%), compared with no predilation (39.0%; adjusted odds ratio [aOR]:0.741, 95% confidence interval [CI]: 0.493–1.114). “Clinically significant” paravalvular leak (PVL) was similar in the predilation (5.9%) and no predilation (6.8%) groups (aOR: 0.886, 95% CI: 0.398–1.971). Permanent pacemaker implantation was higher following predilation (25.1%), compared with no predilation (15.6%; aOR:3.086, 95% CI:1.413–6.738). There were no differences in 30-day myocardial infarction, or 30-day and 1-year stroke and death. When patients undergoing predilation were further stratified into conservative predilation (predilation balloon size ≤ minimum annulus diameter) and aggressive predilation (predilation balloon size > minimum annulus) groups, need for postdilation was lowest with aggressive predilation. PVL, 30-day and 1-year stroke rates were similar in the aggressive, conservative and no predilation groups.

Conclusion: Balloon predilation in TAVR with a self-expanding prosthesis was associated with a significant decrease in the need for balloon postdilation, and a significant increase in the need for a permanent pacemaker. There was no difference in PVL, and 30-day and 1-year stroke and death rates between the two groups.

KEYWORDS:

• Transcatheter aortic valve replacement
• predilation
• postdilation
• self-expanding valve
• CoreValve

Disclosure statements

Dr Deepak L. Bhatt discloses the following relationships – Advisory Board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), Cleveland Clinic, Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine, Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; clinical trial steering committee), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), HMP Communications (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Abbott, Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Chiesi, Eisai, Ethicon, Forest Laboratories, Ironwood, Ischemix, Lilly, Medtronic, PhaseBio, Pfizer, Regeneron, Roche, Sanofi Aventis, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); Site Co-Investigator: Biotronik, Boston Scientific, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, PLx Pharma, Takeda. Dr Kalra is a consultant to Medtronic, Inc. The other authors report no conflicts of interest.

Supplementary material

Supplementary material for this article can be accesssed here.