1-Year Outcomes of Transcatheter Tricuspid Valve Repair

Susheel K. Kodali; Rebecca T. Hahn; Charles J. Davidson; Akhil Narang; Adam Greenbaum; Patrick Gleason; Samir Kapadia; Rhonda Miyasaka; Firas Zahr; Scott Chadderdon; Robert L. Smith; Paul Grayburn; Robert M. Kipperman; Leo Marcoff; Brian Whisenant; Mike Gonzales; Raj Makkar; Moody Makar; William O'Neill; Dee Dee Wang; William A. Gray; Sandra Abramson; James Hermiller; Lucas Mitchel; D. Scott Lim; Dale Fowler; Mathew Williams; Sorin V. Pislaru; Abdellaziz Dahou; Michael J. Mack; Martin B. Leon; Mackram F. Eleid

doi:10.1016/j.jacc.2023.02.049

1-Year Outcomes of Transcatheter Tricuspid Valve Repair

Susheel K. Kodali^*, Rebecca T. Hahn, Charles J. Davidson, Akhil Narang, Adam Greenbaum, Patrick Gleason, Samir Kapadia, Rhonda Miyasaka, Firas Zahr, Scott Chadderdon, Robert L. Smith, Paul Grayburn, Robert M. Kipperman, Leo Marcoff, Brian Whisenant, Mike Gonzales, Raj Makkar, Moody Makar, William O'Neill, Dee Dee WangWilliam A. Gray, Sandra Abramson, James Hermiller, Lucas Mitchel, D. Scott Lim, Dale Fowler, Mathew Williams, Sorin V. Pislaru, Abdellaziz Dahou, Michael J. Mack, Martin B. Leon, Mackram F. Eleid

^*Corresponding author for this work

Medicine, Cardiology Division

Research output: Contribution to journal › Article › peer-review

51 Scopus citations

Abstract

Background: Surgical management of isolated tricuspid regurgitation (TR) is associated with high morbidity and mortality, thereby creating a significant need for a lower-risk transcatheter solution. Objectives: The single-arm, multicenter, prospective CLASP TR (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study) evaluated 1-year outcomes of the PASCAL transcatheter valve repair system (Edwards Lifesciences) to treat TR. Methods: Study inclusion required a previous diagnosis of severe or greater TR and persistent symptoms despite medical treatment. An independent core laboratory evaluated echocardiographic results, and a clinical events committee adjudicated major adverse events. The study evaluated primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints. Study investigators report 1-year all-cause mortality and heart failure hospitalization rates. Results: Sixty-five patients were enrolled: mean age of 77.4 years; 55.4% female; and 97.0% with severe to torrential TR. At 30 days, cardiovascular mortality was 3.1%, the stroke rate was 1.5%, and no device-related reinterventions were reported. Between 30 days and 1 year, there were an additional 3 cardiovascular deaths (4.8%), 2 strokes (3.2%), and 1 unplanned or emergency reintervention (1.6%). One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at least 1 TR grade reduction. Freedom from all-cause mortality and heart failure hospitalization by Kaplan-Meier analyses were 87.9% and 78.5%, respectively. Their New York Heart Association functional class significantly improved (P < 0.001) with 92% in class I or II, 6-minute walk distance increased by 94 m (P = 0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P < 0.001). Conclusions: The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of life at 1 year.

Original language	English (US)
Pages (from-to)	1766-1776
Number of pages	11
Journal	Journal of the American College of Cardiology
Volume	81
Issue number	18
DOIs	https://doi.org/10.1016/j.jacc.2023.02.049
State	Published - May 9 2023

Funding

The authors thank the staff and patients of the study centers who participated in the CLASP TR study. In addition, they thank Edwards Lifesciences TMTT members for their support of this publication: Ted Feldman, MD, Suzanne Y. Gilmore, MPIA, Ann Krzmarzick, MBC, Jeff Kim, PhD, Shekhar H. Deo, MBBS, PhD, Kirk Livingston, Mei Li, PhD, and Lan Xu, PhD.

Keywords

PASCAL
transcatheter tricuspid valve repair
tricuspid regurgitation

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

Access to Document

10.1016/j.jacc.2023.02.049

Cite this

Kodali, S. K., Hahn, R. T., Davidson, C. J., Narang, A., Greenbaum, A., Gleason, P., Kapadia, S., Miyasaka, R., Zahr, F., Chadderdon, S., Smith, R. L., Grayburn, P., Kipperman, R. M., Marcoff, L., Whisenant, B., Gonzales, M., Makkar, R., Makar, M., O'Neill, W., ... Eleid, M. F. (2023). 1-Year Outcomes of Transcatheter Tricuspid Valve Repair. Journal of the American College of Cardiology, 81(18), 1766-1776. https://doi.org/10.1016/j.jacc.2023.02.049

@article{4acff406b53b4732ba40823ebfd897b9,

title = "1-Year Outcomes of Transcatheter Tricuspid Valve Repair",

abstract = "Background: Surgical management of isolated tricuspid regurgitation (TR) is associated with high morbidity and mortality, thereby creating a significant need for a lower-risk transcatheter solution. Objectives: The single-arm, multicenter, prospective CLASP TR (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study) evaluated 1-year outcomes of the PASCAL transcatheter valve repair system (Edwards Lifesciences) to treat TR. Methods: Study inclusion required a previous diagnosis of severe or greater TR and persistent symptoms despite medical treatment. An independent core laboratory evaluated echocardiographic results, and a clinical events committee adjudicated major adverse events. The study evaluated primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints. Study investigators report 1-year all-cause mortality and heart failure hospitalization rates. Results: Sixty-five patients were enrolled: mean age of 77.4 years; 55.4% female; and 97.0% with severe to torrential TR. At 30 days, cardiovascular mortality was 3.1%, the stroke rate was 1.5%, and no device-related reinterventions were reported. Between 30 days and 1 year, there were an additional 3 cardiovascular deaths (4.8%), 2 strokes (3.2%), and 1 unplanned or emergency reintervention (1.6%). One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at least 1 TR grade reduction. Freedom from all-cause mortality and heart failure hospitalization by Kaplan-Meier analyses were 87.9% and 78.5%, respectively. Their New York Heart Association functional class significantly improved (P < 0.001) with 92% in class I or II, 6-minute walk distance increased by 94 m (P = 0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P < 0.001). Conclusions: The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of life at 1 year.",

keywords = "PASCAL, transcatheter tricuspid valve repair, tricuspid regurgitation",

author = "Kodali, {Susheel K.} and Hahn, {Rebecca T.} and Davidson, {Charles J.} and Akhil Narang and Adam Greenbaum and Patrick Gleason and Samir Kapadia and Rhonda Miyasaka and Firas Zahr and Scott Chadderdon and Smith, {Robert L.} and Paul Grayburn and Kipperman, {Robert M.} and Leo Marcoff and Brian Whisenant and Mike Gonzales and Raj Makkar and Moody Makar and William O'Neill and Wang, {Dee Dee} and Gray, {William A.} and Sandra Abramson and James Hermiller and Lucas Mitchel and Lim, {D. Scott} and Dale Fowler and Mathew Williams and Pislaru, {Sorin V.} and Abdellaziz Dahou and Mack, {Michael J.} and Leon, {Martin B.} and Eleid, {Mackram F.}",

note = "Publisher Copyright: {\textcopyright} 2023",

year = "2023",

month = may,

day = "9",

doi = "10.1016/j.jacc.2023.02.049",

language = "English (US)",

volume = "81",

pages = "1766--1776",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier Inc.",

number = "18",

}

Kodali, SK, Hahn, RT, Davidson, CJ , Narang, A, Greenbaum, A, Gleason, P, Kapadia, S, Miyasaka, R, Zahr, F, Chadderdon, S, Smith, RL, Grayburn, P, Kipperman, RM, Marcoff, L, Whisenant, B, Gonzales, M, Makkar, R, Makar, M, O'Neill, W, Wang, DD, Gray, WA, Abramson, S, Hermiller, J, Mitchel, L, Lim, DS, Fowler, D, Williams, M, Pislaru, SV, Dahou, A, Mack, MJ, Leon, MB & Eleid, MF 2023, '1-Year Outcomes of Transcatheter Tricuspid Valve Repair', Journal of the American College of Cardiology, vol. 81, no. 18, pp. 1766-1776. https://doi.org/10.1016/j.jacc.2023.02.049

TY - JOUR

T1 - 1-Year Outcomes of Transcatheter Tricuspid Valve Repair

AU - Kodali, Susheel K.

AU - Hahn, Rebecca T.

AU - Davidson, Charles J.

AU - Narang, Akhil

AU - Greenbaum, Adam

AU - Gleason, Patrick

AU - Kapadia, Samir

AU - Miyasaka, Rhonda

AU - Zahr, Firas

AU - Chadderdon, Scott

AU - Smith, Robert L.

AU - Grayburn, Paul

AU - Kipperman, Robert M.

AU - Marcoff, Leo

AU - Whisenant, Brian

AU - Gonzales, Mike

AU - Makkar, Raj

AU - Makar, Moody

AU - O'Neill, William

AU - Wang, Dee Dee

AU - Gray, William A.

AU - Abramson, Sandra

AU - Hermiller, James

AU - Mitchel, Lucas

AU - Lim, D. Scott

AU - Fowler, Dale

AU - Williams, Mathew

AU - Pislaru, Sorin V.

AU - Dahou, Abdellaziz

AU - Mack, Michael J.

AU - Leon, Martin B.

AU - Eleid, Mackram F.

PY - 2023/5/9

Y1 - 2023/5/9

N2 - Background: Surgical management of isolated tricuspid regurgitation (TR) is associated with high morbidity and mortality, thereby creating a significant need for a lower-risk transcatheter solution. Objectives: The single-arm, multicenter, prospective CLASP TR (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study) evaluated 1-year outcomes of the PASCAL transcatheter valve repair system (Edwards Lifesciences) to treat TR. Methods: Study inclusion required a previous diagnosis of severe or greater TR and persistent symptoms despite medical treatment. An independent core laboratory evaluated echocardiographic results, and a clinical events committee adjudicated major adverse events. The study evaluated primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints. Study investigators report 1-year all-cause mortality and heart failure hospitalization rates. Results: Sixty-five patients were enrolled: mean age of 77.4 years; 55.4% female; and 97.0% with severe to torrential TR. At 30 days, cardiovascular mortality was 3.1%, the stroke rate was 1.5%, and no device-related reinterventions were reported. Between 30 days and 1 year, there were an additional 3 cardiovascular deaths (4.8%), 2 strokes (3.2%), and 1 unplanned or emergency reintervention (1.6%). One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at least 1 TR grade reduction. Freedom from all-cause mortality and heart failure hospitalization by Kaplan-Meier analyses were 87.9% and 78.5%, respectively. Their New York Heart Association functional class significantly improved (P < 0.001) with 92% in class I or II, 6-minute walk distance increased by 94 m (P = 0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P < 0.001). Conclusions: The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of life at 1 year.

AB - Background: Surgical management of isolated tricuspid regurgitation (TR) is associated with high morbidity and mortality, thereby creating a significant need for a lower-risk transcatheter solution. Objectives: The single-arm, multicenter, prospective CLASP TR (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study) evaluated 1-year outcomes of the PASCAL transcatheter valve repair system (Edwards Lifesciences) to treat TR. Methods: Study inclusion required a previous diagnosis of severe or greater TR and persistent symptoms despite medical treatment. An independent core laboratory evaluated echocardiographic results, and a clinical events committee adjudicated major adverse events. The study evaluated primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints. Study investigators report 1-year all-cause mortality and heart failure hospitalization rates. Results: Sixty-five patients were enrolled: mean age of 77.4 years; 55.4% female; and 97.0% with severe to torrential TR. At 30 days, cardiovascular mortality was 3.1%, the stroke rate was 1.5%, and no device-related reinterventions were reported. Between 30 days and 1 year, there were an additional 3 cardiovascular deaths (4.8%), 2 strokes (3.2%), and 1 unplanned or emergency reintervention (1.6%). One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at least 1 TR grade reduction. Freedom from all-cause mortality and heart failure hospitalization by Kaplan-Meier analyses were 87.9% and 78.5%, respectively. Their New York Heart Association functional class significantly improved (P < 0.001) with 92% in class I or II, 6-minute walk distance increased by 94 m (P = 0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P < 0.001). Conclusions: The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of life at 1 year.

KW - PASCAL

KW - transcatheter tricuspid valve repair

KW - tricuspid regurgitation

UR - http://www.scopus.com/inward/record.url?scp=85153088659&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85153088659&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2023.02.049

DO - 10.1016/j.jacc.2023.02.049

M3 - Article

C2 - 37137586

AN - SCOPUS:85153088659

SN - 0735-1097

VL - 81

SP - 1766

EP - 1776

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 18

ER -

1-Year Outcomes of Transcatheter Tricuspid Valve Repair

Abstract

Funding

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this