Author + information
- Received September 13, 2019
- Accepted September 14, 2019
- Published online December 9, 2019.
- Adnan K. Chhatriwalla, MDa,∗ (, )@akcmahi,
- Sreekanth Vemulapalli, MDb,
- Molly Szerlip, MDc,
- Susheel Kodali, MDd,
- Rebecca T. Hahn, MDd,
- John T. Saxon, MDa,
- Michael J. Mack, MDc,
- Gorav Ailawadi, MDe,
- Jennifer Rymer, MDb,
- Pratik Manandhar, MSb,
- Andrzej S. Kosinski, PhDb and
- Paul Sorajja, MDf@PSorajja
- aSaint Luke’s Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri
- bDuke University and Duke Clinical Research Institute, Durham, North Carolina
- cBaylor Scott & White Health, Dallas, Texas
- dColumbia University Medical Center/NY Presbyterian Hospital, New York, New York
- eUniversity of Virginia, Charlottesville, Virginia
- fValve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota
- ↵∗Address for correspondence:
Dr. Adnan K. Chhatriwalla, Saint Luke’s Mid America Heart Institute, 4330 Wornall Road, Suite 2000, Kansas City, Missouri 64111.
Background Transcatheter mitral valve repair (TMVr) for the treatment of mitral regurgitation (MR) is a complex procedure that requires development of a unique skillset.
Objectives The purpose of this study was to examine the relationship between operator experience and procedural results of TMVr.
Methods TMVr device procedures from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry were analyzed with operator case number as a continuous and categorical (1 to 25, 26 to 50, and >50) variable. Outcomes of procedural success, procedural time, and in-hospital procedural complications were examined. The learning curve for the procedure was evaluated using generalized linear mixed models adjusting for baseline clinical variables.
Results All TMVr device procedures (n = 14,923) performed by 562 operators at 290 sites between November 2013 and March 2018 were analyzed. Optimal procedural success (≤1+ residual MR without death or cardiac surgery) increased across categories of operator experience (63.9%, 68.4%, and 75.1%; p < 0.001), while procedural time and procedural complications decreased. Acceptable procedural success (≤2+ residual MR without death or cardiac surgery) also increased with operator experience, but the differences were smaller (91.4%, 92.4%, and 93.8%; p < 0.001). These associations remained significant in adjusted, continuous variable analyses. Visual inflection points in the learning curves for procedural time, procedural success, and procedural complications were evident after approximately 50 cases, with continued improvements observed out to 200 cases.
Conclusions For TMVr device procedures, operator experience was associated with improvements in procedural success, procedure time, and procedural complications. The effect of operator experience was greater when considering the goal of achieving 1+ residual MR.
This research was supported by the ACC/STS TVT Registry. The views expressed in this paper represent those of the author(s), and do not necessarily represent the official views of the registry or its associated professional societies. Dr. Chhatriwalla is a proctor for Edwards Lifesciences and Medtronic; and is on the Speakers Bureau for Abbott Vascular, Edwards Lifesciences, and Medtronic Inc. Dr. Vemulapalli has received grants from Abbott Vascular, Boston Scientific, HeartFlow, American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health, and Patient Centered Outcomes Research Institute; and has served as a consultant to Boston Scientific, Premiere, Janssen, and Zafgen. Dr. Szerlip has served as a speaker and proctor for Edwards Lifesciences; and has served as a speaker for Medtronic. Dr. Kodali has received consulting fees from Edwards Lifesciences, Abbott Vascular, Meril Lifesciences, Claret Medical, and Admedus; is on the Advisory Board of Dura Biotech, Thubrikar Aortic Valve, Inc., and Biotrace Medical; has received honoraria from Abbott Vascular, Meril Lifesciences, Claret Medical, and Admedus; and has equity in Thubrikar Aortic Valve Inc., Dura Biotech, and Biotrace Medical. Dr. Hahn has received speaker fees from Boston Scientific Corporation, Baylis Medical, and Philips Healthcare; and has served as a consultant for Abbott Structural, Edwards Lifesciences, Medtronic, NaviGATE, and Philips Healthcare. Dr. Mack has served as co-principal investigator for the Edwards Lifesciences PARTNER trial and Abbott COAPT trial; and has served as study chair for the Medtronic APOLLO trial. Dr. Ailawadi has served as a consultant for Abbott Vascular, Atricure, Edwards Lifesciences, Medtronic, Gore, and Admedus. Dr. Rymer has received research grants from the American College of Cardiology. Dr. Sorajja has served as a consultant for Abbott Vascular, Medtronic, Boston Scientific, and Integer; and has received research grants and speaker fees from Abbott Vascular, Medtronic, Boston Scientific, and Integer. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Charles Resor, MD, served as Guest Associate Editor for this paper.
- Received September 13, 2019.
- Accepted September 14, 2019.
- 2019 American College of Cardiology Foundation
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