TY - JOUR
T1 - 1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement
T2 - Intrepid TMVR Early Feasibility Study Results
AU - Zahr, Firas
AU - Song, Howard K.
AU - Chadderdon, Scott
AU - Gada, Hemal
AU - Mumtaz, Mubashir
AU - Byrne, Timothy
AU - Kirshner, Merick
AU - Sharma, Samin
AU - Kodali, Susheel
AU - George, Isaac
AU - Merhi, William
AU - Yarboro, Leora
AU - Sorajja, Paul
AU - Bapat, Vinayak
AU - Bajwa, Tanvir
AU - Weiss, Eric
AU - Thaden, Jeremy J.
AU - Gearhart, Elizabeth
AU - Lim, Scott
AU - Reardon, Michael
AU - Adams, David
AU - Mack, Michael
AU - Leon, Martin B.
N1 - Funding Information:
Jessica Dries-Devlin, PhD, CMPP, and Swathi Seshadri, PhD, provided medical writing assistance under the direction of Dr Zahr. Bridget Dahlen and Jennifer Heim provided study management. Katelyn Uithoven, PhD, and Evgenia Nikolsky, MD, PhD, provided scientific review, and Sharla Chenoweth, MS, and Sherlly Xie, PhD, provided statistical oversight. All are employees of Medtronic. The authors thank all the study sites and patients that participated in the trial.
Publisher Copyright:
© 2023 American College of Cardiology Foundation
PY - 2023/12/11
Y1 - 2023/12/11
N2 - Background: High surgical risk may preclude mitral valve replacement in many patients. Transcatheter mitral valve replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients. Objectives: This analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study in patients with ≥moderate-severe MR. Methods: The Intrepid TMVR Early Feasibility Study is a multicenter, prospective, single-arm study. Clinical events were adjudicated by a clinical events committee; endpoints were defined according to Mitral Valve Academic Research Consortium criteria. Results: A total of 33 patients, enrolled at 9 U.S. sites between February 2020 and August 2022, were included. The median age was 80 years, 63.6% of patients were men, and mean Society of Thoracic Surgeons Predicted Risk of Mortality for mitral valve replacement was 5.3%. Thirty-one (93.9%) patients were successfully implanted. Median postprocedural hospitalization length of stay was 5 days, and 87.9% of patients were discharged to home. At 30 days, there were no deaths or strokes, 8 (24.2%) patients had major vascular complications and none required surgical intervention, there were 4 cases of venous thromboembolism all successfully treated without sequelae, and 1 patient had mitral valve reintervention for severe left ventricular outflow tract obstruction. At 1 year, the Kaplan-Meier all-cause mortality rate was 6.7%, echocardiography showed ≤mild valvular MR, there was no/trace paravalvular leak in all patients, median mitral valve mean gradient was 4.6 mm Hg (Q1-Q3: 3.9-5.3 mm Hg), and 91.7% of survivors were in NYHA functional class I/II with a median 11.4-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary scores. Conclusions: The early benefits of the Intrepid transfemoral transseptal TMVR system were maintained up to 1 year with low mortality, low reintervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function.
AB - Background: High surgical risk may preclude mitral valve replacement in many patients. Transcatheter mitral valve replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients. Objectives: This analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study in patients with ≥moderate-severe MR. Methods: The Intrepid TMVR Early Feasibility Study is a multicenter, prospective, single-arm study. Clinical events were adjudicated by a clinical events committee; endpoints were defined according to Mitral Valve Academic Research Consortium criteria. Results: A total of 33 patients, enrolled at 9 U.S. sites between February 2020 and August 2022, were included. The median age was 80 years, 63.6% of patients were men, and mean Society of Thoracic Surgeons Predicted Risk of Mortality for mitral valve replacement was 5.3%. Thirty-one (93.9%) patients were successfully implanted. Median postprocedural hospitalization length of stay was 5 days, and 87.9% of patients were discharged to home. At 30 days, there were no deaths or strokes, 8 (24.2%) patients had major vascular complications and none required surgical intervention, there were 4 cases of venous thromboembolism all successfully treated without sequelae, and 1 patient had mitral valve reintervention for severe left ventricular outflow tract obstruction. At 1 year, the Kaplan-Meier all-cause mortality rate was 6.7%, echocardiography showed ≤mild valvular MR, there was no/trace paravalvular leak in all patients, median mitral valve mean gradient was 4.6 mm Hg (Q1-Q3: 3.9-5.3 mm Hg), and 91.7% of survivors were in NYHA functional class I/II with a median 11.4-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary scores. Conclusions: The early benefits of the Intrepid transfemoral transseptal TMVR system were maintained up to 1 year with low mortality, low reintervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function.
KW - mitral regurgitation
KW - TMVR
KW - trans-septal
KW - transcatheter mitral valve replacement
KW - transfemoral
KW - Mitral Valve Insufficiency/diagnostic imaging
KW - Heart Valve Prosthesis Implantation
KW - Prospective Studies
KW - Humans
KW - Mitral Valve/diagnostic imaging
KW - Heart Valve Prosthesis
KW - Male
KW - Treatment Outcome
KW - Feasibility Studies
KW - Cardiac Catheterization/methods
KW - Aged, 80 and over
KW - Female
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UR - http://www.scopus.com/inward/citedby.url?scp=85178097731&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2023.10.001
DO - 10.1016/j.jcin.2023.10.001
M3 - Article
C2 - 37902145
AN - SCOPUS:85178097731
SN - 1936-8798
VL - 16
SP - 2868
EP - 2879
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 23
ER -