Author + information
- Received July 29, 2019
- Revision received September 30, 2019
- Accepted October 9, 2019
- Published online March 2, 2020.
- Maurizio Taramasso, MD, PhDa,∗ (, )
- Mara Gavazzoni, MDa,
- Alberto Pozzoli, MDa,
- Hannes Alessandrini, MDb,
- Azeem Latib, MDc,
- Adrian Attinger-Toller, MDd,
- Luigi Biasco, MDe,
- Daniel Braun, MDf,
- Eric Brochet, MDg,
- Kim A. Connelly, MDh,
- Sabine de Bruijn, MDi,
- Paolo Denti, MDj,
- Florian Deuschl, MDk,
- Rodrigo Estevez-Louriero, MD, PhDl,
- Neil Fam, MDh,
- Christian Frerker, MDb,
- Edwin Ho, MDc,h,
- Jean-Michel Juliard, MDg,
- Ryan Kaple, MDm,
- Susheel Kodali, MDn,
- Felix Kreidel, MDo,
- Karl-Heinz Kuck, MDb,
- Alexander Lauten, MDp,
- Julia Lurz, MDq,
- Vanessa Monivas, MDl,
- Michael Mehr, MDf,
- Tamin Nazif, MDn,
- Georg Nickening, MDr,
- Giovanni Pedrazzini, MDe,
- Fabien Praz, MDs,
- Rishi Puri, MDt,
- Josep Rodés-Cabau, MDt,
- Ulrich Schäfer, MDk,
- Joachim Schofer, MDu,
- Horst Sievert, MDi,
- Gilbert H.L. Tang, MD, MSC, MBAv,
- Ahmed A. Khattab, MDa,w,x,
- Holger Thiele, MDq,
- Matthias Unterhuber, MDq,
- Alec Vahanian, MDg,
- Ralph Stephan Von Bardeleben, MDo,
- John G. Webb, MDd,
- Marcel Weber, MDr,
- Stephan Windecker, MDs,
- Mirjam Winkel, MDs,
- Michel Zuber, MDa,
- Jörg Hausleiter, MDf,
- Philipp Lurz, MD, PhDq,
- Francesco Maisano, MDa,
- Martin B. Leon, MDn and
- Rebecca T. Hahn, MDn
- aCardiology Department, University Hospital of Zurich, University of Zurich, Zurich, Switzerland
- bCardiology Department, Asklepios Klinik St. Georg, Hamburg, Germany
- cCardiology Department, Montefiore Medical Center, New York, New York
- dCardiology Department, St. Paul Hospital, Vancouver, Canada
- eCardiology Department, Cardiocentro, Lugano, Switzerland
- fCardiology Department, Klinikum der Universität München, Munich, Germany
- gCardiology Department, Hôpital Bichat, Université Paris VI, Paris, France
- hCardiology Department, Toronto Heart Center, St. Michael’s Hospital, Toronto, Canada
- iCardiology Department, CardioVascular Center Frankfurt, Frankfurt am Main, Germany
- jCardiac Surgery Department, San Raffaele University Hospital, Milan, Italy
- kCardiology Department, University Heart Center Hamburg, Hamburg, Germany
- lCardiology Department, Department of Cardiology, Hospital Universitario Puerta de Hierro, Madrid, Spain
- mCardiology Department, Westchester Medical Center, Valhalla, New York
- nCardiology Department, New York-Presbyterian/Columbia University Medical Center, New York, New York
- oCardiology Department, Department of Cardiology, University Medical Center Mainz, Mainz, Germany
- pCardiology Department, Charité University Hospital, Berlin, Germany
- qCardiology Department, Heart Center Leipzig, University Hospital Leipzig, Leipzig, Germany
- rCardiology Department, Universitatsklinikum Bonn, Bonn, Germany
- sCardiology Department, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
- tCardiology Department, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada
- uCardiology Department, Albertinen Heart Center, Hamburg, Germany
- vCardiac Surgery Department, Mount Sinai Hospital, New York, New York
- wCardiology Department, Cardiance Clinic, Pfäffikon, Switzerland
- xCardiology Department, University of Bern, Bern, Switzerland
- ↵∗Address for correspondence:
Dr. Maurizio Taramasso, University Hospital of Zurich, Cardiovascular Surgery Department, Rämistrasse 100, 8091 Zurich, Switzerland.
Objectives The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear.
Background Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis.
Methods The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed.
Results Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm2 vs. 0.6 ± 0.3 cm2; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30).
Conclusions TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead.
Dr. Taramasso has served as a consultant for Abbott Vascular, Boston Scientific, 4Tech, and CoreMedic; and has received speaker honoraria from Edwards Lifesciences. Dr. Gavazzoni has served as a consultant for Biotronik. Dr. Latib has served on the advisory board for Medtronic and Abbott Vascular; has served on the Speakers Bureau for Abbott Vascular; has served on the scientific advisory board for Millipede; and has served as a consultant for 4Tech, Mitralign, and Millipede. Dr. Braun has received speaker honoraria and travel support from Abbott Vascular. Dr. Brochet has received speaker fees from Abbott Vascular. Dr. Connelly has received honoraria from Abbott Industries. Dr. Denti has served as a consultant for Abbott Vascular, 4Tech, Neovasc, and InnovHeart; and has received honoraria from Abbott and Edwards Lifesciences. Dr. Deuschl has served as a proctor and consultant for Valtech/Edwards Lifesciences and Neovasc; has received speaker honoraria from Abbott; and has received unrestricted travel grants from Boston Scientific, Abbott, Edwards Lifesciences, and Neovasc. Dr. Kodali has served on the scientific advisory board for Microinterventional Devices, Dura Biotech, Thubrikar Aortic Valve, and Supira; has served as a consultant for Meril Lifesciences, Admedus, Medtronic, and Boston Scientific; has served on the steering committee for Edwards Lifesciences and Abbott Vascular; has received honoraria from Meril Lifesciences, Admedus, Abbott Vascular, and Dura Biotech; and owns equity in Dura Biotech, Thubrikar Aortic Valve, Supira, and MID. Dr. Kreidel has received speaker honoraria and consulting fees from Abbott and Edwards Lifesciences. Dr. Kuck has served as a consultant for Abbott Vascular, St. Jude Medical, Biotronik, Medtronic, Biosense Webster, Boston Scientific, Edwards Lifesciences, and Mitralign; and is cofounder of Cardiac Implants. Dr. Lauten has received research support from Abbott and Edwards Lifesciences; and has been a consultant to Abbott, Edwards Lifesciences, and TricValve. Dr. Lurz has received speaker fees from Abbott. Dr. Mehr has received a travel grant from Bristol-Myers Squibb. Dr. Nazif has served as a consultant for and received consulting honoraria from Edwards Lifesciences, Boston Scientific, Medtronic, and Biotrace Medical. Dr. Praz has been a consultant to Edwards Lifesciences. Dr. Rodés-Cabau has received institutional research grants from Edwards Lifesciences. Dr. Schäfer has received lecture fees, study honoraria, travel expenses from, and has been a member of an advisory board for Abbott. Dr. Sievert has received study honoraria, travel expenses, and consulting fees from 4Tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed BV, Contego, CVRx, Edwards Lifesciences, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, PFM Medical, ReCor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, and Vivasure Medical. Dr. Tang has served as a consultant, advisory board member, and faculty trainer for Abbott Structural Heart. Dr. Vahanian has served as a consultant for Abbott Vascular, Edwards Lifesciences, MitralTech, and Cardiovalve; and has received speaker fees from Abbott Vascular and Edwards Lifesciences. Dr. Webb has received research support from Edwards Lifesciences; and has served as a consultant for Abbott Vascular, Edwards Lifesciences, and St. Jude Medical. Dr. Windecker has received institutional research grants from Abbott, Amgen, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, St. Jude Medical, and Terumo. Dr. Hausleiter has received speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr. Maisano has served as a consultant for and received consulting fees and honoraria from Abbott Vascular, Edwards Lifesciences, Cardiovalve, SwissVortex, Perifect, Xeltis, Transseptal Solutions, Magenta, Valtech, and Medtronic; is cofounder of 4Tech; has received research grant support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received royalties and owns intellectual property rights from Edwards Lifesciences (FMR surgical annuloplasty); and is a shareholder in Cardiovalve, Swiss Vortex, Magenta, Transseptal Solutions, Occlufit, 4Tech, and Perifect. Dr. Leon has served as a nonpaid member of the scientific advisory board of Edwards Lifesciences; and has been a consultant to Abbott Vascular and Boston Scientific. Dr. Hahn has served as a consultant for Abbott Vascular, Abbott Structural, NaviGate, Philips Healthcare, Medtronic, Edwards Lifesciences, and GE Healthcare; is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-supported trials, for which she receives no direct industry compensation; has received speaker fees from Boston Scientific and Baylis Medical; and has received nonfinancial support from 3mensio. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 29, 2019.
- Revision received September 30, 2019.
- Accepted October 9, 2019.
- 2020 American College of Cardiology Foundation
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