TY - JOUR
T1 - Characterization of Screen Failures Among Patients Evaluated for Transcatheter Tricuspid Valve Repair (TriSelect-Study)
AU - Gerçek, Muhammed
AU - Goncharov, Arseniy
AU - Narang, Akhil
AU - Körber, Maria l.
AU - Friedrichs, Kai P.
AU - Baldridge, Abigail S.
AU - Meng, Zhiying
AU - Puthumana, Jyothy J.
AU - Davidson, Laura J.
AU - Malaisrie, S. Christopher
AU - Thomas, James D.
AU - Rudolph, Tanja K.
AU - Pfister, Roman
AU - Rudolph, Volker
AU - Davidson, Charles J.
N1 - Funding Information:
The authors thank Miriam Switek for graphics. The research reported in this publication was supported, in part, by the Bluhm Cardiovascular Institute Clinical Trials Unit at Northwestern University Feinberg School of Medicine.
Funding Information:
The authors thank Miriam Switek for graphics. The research reported in this publication was supported, in part, by the Bluhm Cardiovascular Institute Clinical Trials Unit at Northwestern University Feinberg School of Medicine.
Publisher Copyright:
© 2023 American College of Cardiology Foundation
PY - 2023/7/10
Y1 - 2023/7/10
N2 - Background: Transcatheter tricuspid valve repair (TTVr) has significantly expanded treatment options for tricuspid regurgitation (TR). However, a sizeable proportion of patients are still declined for TTVr and little is known about their clinical characteristics and cardiac morphology. Objectives: This study sought to characterize patients who screen fail for TTVr with respect to their clinical characteristics and cardiac morphology. Methods: A total of 547 patients were evaluated for TTVr between January 2016 to December 2021 from 3 centers in the United States and Germany. Clinical records and echocardiographic studies were used to assess medical history and right ventricular (RV) and tricuspid valve (TV) characteristics. Results: Median age was 80 (IQR: 74-83) years and 60.0% were female. Over half (58.1%) were accepted for TTVr. Of those who were deemed unsuitable for TTVr (41.9%), the most common exclusion reasons were anatomical criteria (56.8%). In the regression analysis, RV and right atrial size, TV coaptation gap, and tethering area were identified as independent screen failure predictors. Other rejection reasons included clinical futility (17.9%), low symptom burden (12.7%), and technical limitations (12.7%). Most of the excluded patients (71.6%) were managed conservatively with medical therapy, while a small number either proceeded to TV surgery (22.3%) or subsequently became eligible for transcatheter tricuspid valve replacement in later available clinical trials in the United States (6.1%). Conclusions: The majority of TTVr screen failure patients are excluded due to TV, right atrial, and RV enlargement. However, a significant proportion is excluded due to clinical futility. These identifiable anatomical and clinical characteristics emphasize the importance of earlier referral and intervention of TR and the need for continued innovation of Transcatheter tricuspid valve interventions.
AB - Background: Transcatheter tricuspid valve repair (TTVr) has significantly expanded treatment options for tricuspid regurgitation (TR). However, a sizeable proportion of patients are still declined for TTVr and little is known about their clinical characteristics and cardiac morphology. Objectives: This study sought to characterize patients who screen fail for TTVr with respect to their clinical characteristics and cardiac morphology. Methods: A total of 547 patients were evaluated for TTVr between January 2016 to December 2021 from 3 centers in the United States and Germany. Clinical records and echocardiographic studies were used to assess medical history and right ventricular (RV) and tricuspid valve (TV) characteristics. Results: Median age was 80 (IQR: 74-83) years and 60.0% were female. Over half (58.1%) were accepted for TTVr. Of those who were deemed unsuitable for TTVr (41.9%), the most common exclusion reasons were anatomical criteria (56.8%). In the regression analysis, RV and right atrial size, TV coaptation gap, and tethering area were identified as independent screen failure predictors. Other rejection reasons included clinical futility (17.9%), low symptom burden (12.7%), and technical limitations (12.7%). Most of the excluded patients (71.6%) were managed conservatively with medical therapy, while a small number either proceeded to TV surgery (22.3%) or subsequently became eligible for transcatheter tricuspid valve replacement in later available clinical trials in the United States (6.1%). Conclusions: The majority of TTVr screen failure patients are excluded due to TV, right atrial, and RV enlargement. However, a significant proportion is excluded due to clinical futility. These identifiable anatomical and clinical characteristics emphasize the importance of earlier referral and intervention of TR and the need for continued innovation of Transcatheter tricuspid valve interventions.
KW - annular reduction
KW - right heart dilation
KW - right ventricular function
KW - transcatheter therapy
KW - tricuspid regurgitation
KW - tricuspid valve
KW - tricuspid valve repair
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U2 - 10.1016/j.jcin.2023.03.036
DO - 10.1016/j.jcin.2023.03.036
M3 - Article
C2 - 37438025
AN - SCOPUS:85163476541
SN - 1936-8798
VL - 16
SP - 1579
EP - 1589
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 13
ER -