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Geometric Ring Annuloplasty for Aortic Valve Repair During Aortic Aneurysm Surgery: Two-Year Clinical Trial Results

Rankin, J. Scott, MD*; Mazzitelli, Domenico, MD; Fischlein, Theodor, MD; Choi, Yeong-Hoon, MD, PhD§; Pirk, Jan, MD; Pfeiffer, Steffen, MD; Wei, Lawrence M., MD*; Badhwar, Vinay, MD*

Innovations:Technology and Techniques in Cardiothoracic and Vascular Surgery: July/August 2018 - Volume 13 - Issue 4 - p 248–253
doi: 10.1097/IMI.0000000000000539
Original Articles

Objective An aortic annuloplasty ring could be useful for aortic valve repair. This trial evaluated intermediate-term outcomes of internal geometric ring annuloplasty for repair of trileaflet and bicuspid aortic insufficiency associated with ascending aortic and/or aortic root aneurysms.

Methods Under regulatory supervision, 47 patients with aortic insufficiency and ascending aortic (n = 22) and/or aortic root (n = 25) aneurysms were managed with aortic valve repair and aneurysm resection. Valve repair was performed using trileaflet (n = 40) or bicuspid (n = 7) internal geometric rings, together with leaflet reconstruction. Ascending aortic and/or remodeling root replacements were accomplished with Dacron grafts 5 to 7 mm larger than the rings. An Echo Core Lab provided independent echocardiographic assessments, and changes over time were evaluated by Friedman tests.

Results Mean ± SD age was 60 ± 14 years, 57% (27/47) were male, 15% (7/47) had bicuspid valves, 87% (41/47) had moderate-to-severe aortic insufficiency, and 13% (6/47) had mild aortic insufficiency. All patients had annular dilatation, with a mean ± SD of 26.5 ± 2.6 mm before repair, and mean ± SD ring sizes were 21.7 ± 1.7 mm. Follow-up was 42 months (mean = 27 months). No operative mortality or valve-related complications occurred. Two patients died beyond 1 year from nonvalve-related causes. One patient required valve replacement for repair failure. Survival free of complications or valve replacement was 94% at 2 years. Significant reduction in aortic insufficiency and New York Heart Association class were observed (P < 0.0001), and valve gradients remained low. No heart block or direct ring complications occurred.

Conclusions In preliminary regulatory studies, aortic ring annuloplasty seemed safe and effective during aortic aneurysm surgery. This approach could help standardize aortic valve repair.

From the *Department of Cardiovascular and Thoracic Surgery, West Virginia University Heart and Vascular Institute, Morgantown, WV USA;

Department of Cardiac Surgery, Klinikum Bogenhausen, Munich, Germany;

Department of Cardiovascular Surgery, Klinikum Nürnberg, Paracelsus Medical University, Nürnberg, Germany;

§Department of Cardiac and Thoracic Surgery, University of Köln, Köln, Germany; and

Department of Cardiac Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.

Accepted for publication June 15, 2018.

Supported by BioStable Science and Engineering, Inc, Austin, TX USA (http://www.biostable-s-e.com). This multicenter clinical trial of the HAART 300 and 200 rings was performed in Europe, the HAART 300 device is now clinically approved in Europe (CE 613269), and both are approved in the United States by the FDA (21 CFR 870.3800).

The information in this article was generated in a prospective regulatory clinical trial of aortic ring annuloplasty (ClinicalTrials.gov: NCT01400841, NCT01732835, and NCT02071849).

Disclosures: J. Scott Rankin, MD, is a consultant for BioStable Science and Engineering, Inc, Austin, TX USA, and AtriCure, West Chester, OH USA. Theodor Fischlein, MD, is a consultant for BioStable Science and Engineering, Inc, Austin, TX USA, and LivaNova, London, UK. Domenico Mazzitelli, MD, and Yeong-Hoon Choi, MD, PhD, are consultants for BioStable Science and Engineering, Inc, Austin, TX USA. Jan Pirk, MD, Steffen Pfeiffer, MD, Lawrence M. Wei, MD, and Vinay Badhwar, MD, declare no conflicts of interest.

Address correspondence and reprint requests to J. Scott Rankin, MD, Department of Cardiac and Thoracic Surgery, WVU Heart and Vascular Institute, West Virginia University, 1 Medical Center Dr, Morgantown, WV 25605 USA. E-mail: jsrankinmd@cs.com.

©2018 by the International Society for Minimally Invasive Cardiothoracic Surgery