TY - JOUR
T1 - Transcatheter Left Ventricular Restoration in Patients With Heart Failure
AU - Hamid, NADIRA
AU - JORDE, ULRICH P.
AU - REISMAN, M. A.R.K.
AU - LATIB, AZEEM
AU - LIM, D. SCOTT
AU - JOSEPH, SUSAN M.
AU - KURLIANSKAYA, ALENA
AU - POLONETSKY, O. L.E.G.
AU - NEUZIL, P. E.T.R.
AU - REDDY, VIVEK
AU - FOERST, JASON
AU - GADA, HEMAL
AU - GRUBB, KENDRA J.
AU - SILVA, GUILHERME
AU - KEREIAKES, D. E.A.N.
AU - SHREENIVAS, SATYA
AU - PINNEY, S. E.A.N.
AU - DAVIDAVICIUS, GIEDRIUS
AU - SORAJJA, P. A.U.L.
AU - BOEHMER, JOHN P.
AU - KLEBER, FRANZ X.
AU - PERIER, PATRICK
AU - VAN MIEGHEM, NICOLAS M.
AU - DUMONTEIL, NICOLAS
AU - LEON, MARTIN B.
AU - BURKHOFF, DANIEL
N1 - Publisher Copyright:
© 2023 The Authors
PY - 2023/7
Y1 - 2023/7
N2 - Background: Left ventricular (LV) volume reshaping reduces myocardial wall stress and may induce reverse remodeling in patients with heart failure with reduced ejection fraction. The AccuCinch Transcatheter Left Ventricular Restoration system consists of a series of anchors connected by a cable implanted along the LV base that is cinched to the basal free wall radius. We evaluated the echocardiographic and clinical outcomes following transcatheter left ventricular restoration. Methods and Results: We analyzed 51 heart failure patients with a left ventricular ejection fraction between 20% and 40%, with no more than 2+ mitral regurgitation treated with optimal medical therapy, who subsequently underwent transcatheter left ventricular restoration. Serial echocardiograms, Kansas City Cardiomyopathy Questionnaire scores, and 6-minute walk test distances were measured at baseline through 12 months. Primary analysis end point was change in end-diastolic volume at 12 months compared with baseline. Patients (n = 51) were predominantly male (86%) with a mean age of 56.3 ± 13.1 years. Fluoroscopy showed LV free wall radius decreased by a median of 9.2 mm amounting to a 29.6% decrease in the free wall arc length. At 12 months, the LV end-diastolic volume decreased by 33.6 ± 34.8 mL (P < .01), with comparable decreases in the LV end-systolic volume. These decreases were associated with significant improvements in the overall Kansas City Cardiomyopathy Questionnaire score (16.4 ± 18.7 points; P < .01) and 6-minute hall walk test distance (45.9 ± 83.9 m; P < .01). There were no periprocedural deaths; through the 1-year follow-up, 1 patient died (day 280) and 1 patient received a left ventricular assist device (day 13). Conclusions: In patients with heart failure with reduced ejection fraction without significant mitral regurgitation receiving optimal medical therapy, the AccuCinch System resulted in decreases of LV volume, as well as improved quality of life and exercise endurance. A randomized trial is ongoing (NCT04331769).
AB - Background: Left ventricular (LV) volume reshaping reduces myocardial wall stress and may induce reverse remodeling in patients with heart failure with reduced ejection fraction. The AccuCinch Transcatheter Left Ventricular Restoration system consists of a series of anchors connected by a cable implanted along the LV base that is cinched to the basal free wall radius. We evaluated the echocardiographic and clinical outcomes following transcatheter left ventricular restoration. Methods and Results: We analyzed 51 heart failure patients with a left ventricular ejection fraction between 20% and 40%, with no more than 2+ mitral regurgitation treated with optimal medical therapy, who subsequently underwent transcatheter left ventricular restoration. Serial echocardiograms, Kansas City Cardiomyopathy Questionnaire scores, and 6-minute walk test distances were measured at baseline through 12 months. Primary analysis end point was change in end-diastolic volume at 12 months compared with baseline. Patients (n = 51) were predominantly male (86%) with a mean age of 56.3 ± 13.1 years. Fluoroscopy showed LV free wall radius decreased by a median of 9.2 mm amounting to a 29.6% decrease in the free wall arc length. At 12 months, the LV end-diastolic volume decreased by 33.6 ± 34.8 mL (P < .01), with comparable decreases in the LV end-systolic volume. These decreases were associated with significant improvements in the overall Kansas City Cardiomyopathy Questionnaire score (16.4 ± 18.7 points; P < .01) and 6-minute hall walk test distance (45.9 ± 83.9 m; P < .01). There were no periprocedural deaths; through the 1-year follow-up, 1 patient died (day 280) and 1 patient received a left ventricular assist device (day 13). Conclusions: In patients with heart failure with reduced ejection fraction without significant mitral regurgitation receiving optimal medical therapy, the AccuCinch System resulted in decreases of LV volume, as well as improved quality of life and exercise endurance. A randomized trial is ongoing (NCT04331769).
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U2 - 10.1016/j.cardfail.2023.03.003
DO - 10.1016/j.cardfail.2023.03.003
M3 - Article
C2 - 36958391
AN - SCOPUS:85159145637
SN - 1071-9164
VL - 29
SP - 1046
EP - 1055
JO - Journal of Cardiac Failure
JF - Journal of Cardiac Failure
IS - 7
ER -