Author + information
- Adnan K. Chhatriwalla, MD1,∗ (, )@akcmahi,
- Sreekanth Vemulapalli, MD2,
- Molly Szerlip, MD3,
- Susheel Kodali, MD4,
- Rebecca T. Hahn, MD4,
- John T. Saxon, MD1,
- Michael J. Mack, MD3,
- Gorav Ailawadi, MD5,
- Jennifer Rymer, MD2,
- Pratik Manandhar, MS2,
- Andrzej S. Kosinski, PhD2 and
- Paul Sorajja, MD6
- 1Saint Luke’s Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, MO
- 2Duke University and Duke Clinical Research Institute, Durham, NC
- 3Baylor Scott & White Health, Dallas, TX
- 4Columbia University Medical Center/ NY Presbyterian Hospital, New York, NY
- 5University of Virginia, Charlottesville, VA
- 6Valve Science Center, Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, MN
- ↵∗Corresponding Author: Adnan K. Chhatriwalla, MD Saint Luke’s Mid America Heart Institute 4330 Wornall Road, Suite 2000 Kansas City, Missouri 64111 Telephone: 816-751-8571 Fax: 816-751-8635.
Background Transcatheter mitral valve repair (TMVr) for the treatment of mitral regurgitation (MR) is a complex procedure that requires development of a unique skillset.
Objective To examine the relationship between operator experience and procedural results of TMVr with MitraClip (Abbott Structural, Santa Clara, CA).
Methods TMVr device procedures from the STS/ACC TVT Registry were analyzed with operator case number as a continuous and categorical (1-25, 26-50, 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 up to 200 cases.
Conclusions For TMVr device proceedures, operator experience was associated with improvements in procedural success, procedure time, and procedural complications. The impact of operator experience was greater when considering the goal of achieving 1+ residual MR.
Dr. Chhatriwalla is a proctor for Edwards Lifesciences and Medtronic Inc. and is on the Speaker Bureau for Abbott Vascular, Edwards Lifesciences and Medtronic Inc.
Dr. Vemulapalli has 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. He serves as a consultant to Boston Scientific, Premiere, Janssen, and Zafgen.
Dr. Szerlip has served as a speaker and proctor for Edwards Lifesciences and as a speaker for Medtronic Inc.
Dr. Kodali has received consulting fees from Edwards Lifesciences, Abbott Vascular, Meril Lifesciences, Claret Medical, 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. R. Hahn reports speaker fees from Boston Scientific Corporation, Baylis Medical and Philips Healthcare; consulting for Abbott Structural, Edwards Lifesciences, Medtronic, NaviGATE, 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 is a consultant with Abbott Vascular, Atricure, Edwards Lifesciences, Medtronic Inc., Gore and Admedus.
Dr. Sorajja is a consultant with Abbott Vascular, Medtronic, Boston Scientific, and Integer; and has received research grants and speakers fees from Abbott Vascular, Medtronic, Boston Scientific, and Integer.
Dr. Rymer reports research grants from the American College of Cardiology
Saxon, Manandhar and Kosinski have no conflicts to report.
This research was supported by the ACC/STS TVT Registry. The views expressed in this manuscript represent those of the author(s), and do not necessarily represent the official views of the registry or its associated professional societies identified at CVQuality.ACC.org/NCDR.
Tweet: For TMVr with MitraClip, procedural success, procedure time, and procedural complications improve with increasing operator experience.
- Received September 13, 2019.
- Accepted September 14, 2019.
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