Original Investigation
Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction

https://doi.org/10.1016/j.jacc.2020.02.051Get rights and content
Under an Elsevier user license
open archive

Abstract

Background

Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail.

Objectives

The authors sought to examine outcomes following redo-TAVR.

Methods

The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively.

Results

Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis–regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm2 and 1.51 ± 0.57 cm2; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively.

Conclusions

Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.

Key Words

durability
transcatheter aortic valve replacement
transcatheter heart valve
valve-in-valve

Abbreviations and Acronyms

AR
aortic regurgitation
AS
aortic stenosis
CT
computed tomography
TAVR
transcatheter aortic valve replacement
THV
transcatheter heart valve
VARC-2
Valve Academic Research Consortium-2

Cited by (0)

Dr. Webb has been a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and ViVitro Labs. Dr. Sondergaard has received consultant fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic and Symetis. Dr. Kim has been a proctor for Boston Scientific and Abbott Vascular; and has received speaker fees from Edwards Lifesciences and Medtronic. Dr. Hamm has served on an Advisory Board for Medtronic. Dr. Schofer has received speaker fees from Boston Scientific; and has received travel compensation from Edwards Lifesciences, Boston Scientific, and Abbott/St. Jude Medical. Dr. Guerrero has received research grant support from Edwards Lifesciences. Dr. Rodés-Cabau has received institutional research grants from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Pilgrim has received institutional research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; has been a consultant to Biotronik and HighLife SAS; and has received speaker fees from Boston Scientific and Biotronik. Dr. Nombela-Franco has served as a proctor for Abbott; and has received speaker honoraria from Edwards Lifesciences. Dr. Van Mieghem has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received advisory fees from Abbott, Boston Scientific, and Medtronic. Dr. Tamburino has served as a speaker and consultant for Medtronic; and has received speaker honoraria from Daiichi-Sankyo, Biosensor, Meril, Boheringer Ingelheim, and Balmed. Dr. Sinning: has received speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Danenberg has been a proctor for Medtronic; and served on a Speakers Bureau for Edwards Lifesciences. Dr. Tarantini has been a consultant to and has received lecture fees from Medtronic, Edwards Lifesciences, Abbott Vascular, Boston Scientific, and GADA. Dr. Redwood has been a proctor for and has received lecture fees from Edwards Lifesciences. Dr. Babaliaros has been a consultant to Edwards Lifesciences; and holds equity in Transmural Systems. Dr. Castriota has been a proctor for Medtronic and Boston Scientific. Dr. Piazza has been a consultant to Medtronic and MicroPort. Dr. H. Sievert has received study honoraria to his institution, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Cardiac Success, Cardimed, Celonova, Comed B.V., Contego, CVRx, Dinova, Edwards, Endologix, Endomatic, Hemoteq, Hangzhou Nuomao Medtech, Holistick Medical, Lifetech, Maquet Getinge Group, Medtronic, Mokita, Occlutech, Recor, Renal Guard, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, and Vivasure Medical. Dr. Andreas has been a proctor for Edwards Lifesciences and Abbott; and has been an Advisory Board member for Medtronic. Dr. Latib has been an Advisory Board member for Medtronic and Abbott; and has been a consultant for Edwards Lifesciences. Dr. Hildick-Smith has been a proctor and advisory to Boston Scientific, Abbott, Medtronic, and Edwards Lifesciences. Dr. Sathananthan has been a consultant to Edwards Lifesciences. Dr. Blanke has been a consultant to Edwards Lifesciences, Tendyne, Neovasc, Circel Cardiovascular Imaging, and W. L. Gore. Dr. Leipsic has been a consultant to Circle CVI, HeartFlow, and Edwards Lifesciences; has received research grants from Edwards Lifesciences and GE Healthcare; has stock options in HeartFlow; and has provided institutional core laboratory services to Edwards Lifesciences, Abbott, Medtronic, and Neovasc. Dr. Wood has been a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. Dr. Nazif has been a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Kodali has received grants from Edwards Lifesciences, Medtronic, and Boston Scientific; has received grants and personal fees from Abbott Vascular and JenaValve; has received personal fees from Meril Lifesciences and Admedus; and has equity in Admedus, Supira, Microinterventional Devices, Dura Biotech, and Thubrikar Aortic Valve Inc. Dr. Barbanti has been a consultant for Edwards Lifesciences; and has been an Advisory Board member for Biotronik. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Vinod H. Thourani, MD, served as Guest Associate Editor for this paper.

Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.