Ori Ben-Yehuda1, Bahira Shahim2, Shmuel Chen3, Mengdan Liu2, Bjorn Redfors2, Rebecca T Hahn3, Federico M Asch4, Neil J Weissman4, Diego Medvedofsky4, Rishi Puri5, Samir Kapadia5, Anna Sannino6, Paul Grayburn6, Saibal Kar7, Scott Lim8, JoAnn Lindenfeld9, William T Abraham10, Michael J Mack6, Gregg W Stone11. 1. Cardiovascular Research Foundation, New York, New York. Electronic address: obenyehuda@crf.org. 2. Cardiovascular Research Foundation, New York, New York. 3. Cardiovascular Research Foundation, New York, New York; Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York. 4. Medstar Health Research Institute, Washington, DC. 5. Cleveland Clinic, Cleveland, Ohio. 6. Baylor Scott & White Health, Plano, Texas. 7. Los Robles Regional Medical Center, Thousand Oaks, California. 8. University of Virginia, Charlottesville, Virginia. 9. Vanderbilt University Medical Center, Nashville, Tennessee. 10. Ohio State University Medical Center, Columbus, Ohio. 11. Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
Abstract
BACKGROUND: Pulmonary hypertension worsens prognosis in patients with heart failure (HF) and secondary mitral regurgitation (SMR). OBJECTIVES: This study sought to determine whether baseline pulmonary hypertension influences outcomes of transcatheter mitral valve repair (TMVr) in patients with HF with SMR. METHODS: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, 614 patients with HF with moderate-to-severe or severe SMR were randomized to TMVr with the MitraClip plus guideline-directed medical therapy (GDMT) (n = 302) versus GDMT alone (n = 312). Baseline pulmonary artery systolic pressure (PASP) estimated from echocardiography was categorized as substantially increased (≥50mm Hg) versus not substantially increased (<50 mm Hg). RESULTS: Among 528 patients, 184 (82 TMVr, 102 GDMT) had PASP of≥50 mm Hg (mean: 59.1 ± 8.8 mm Hg) and 344 (171 TMVr, 173 GDMT) had PASP of <50 mm Hg (mean: 36.3 ± 8.1 mm Hg). Patients with PASP of ≥50mm Hg had higher 2-year rates of death or HF hospitalization (HFH) compared to those with PASP of <50mm Hg (68.8% vs. 49.1%; adjusted hazard ratio: 1.52; 95% confidence interval: 1.17 to 1.97; p = 0.002). Rates of death or HFH were reduced by TMVr versus GDMT alone, irrespective of baseline PASP (pinteraction = 0.45). TMVr reduced PASP from baseline to 30 days to a greater than GDMT alone (adjusted least squares mean: -4.0 vs. -0.9 mm Hg; p = 0.006), a change that was associated with reduced risk of death or HFH between 30 days and 2 years (adjusted hazard ratio: 0.91 per -5 mm Hg PASP; 95% confidence interval: 0.86 to 0.96; p = 0.0009). CONCLUSIONS: Elevated PASP is associated with a worse prognosis in patients with HF with severe SMR. TMVr with the MitraClip reduced 30-day PASP and 2-year rates of death or HFH compared with GDMT alone, irrespective of PASP.
RCT Entities:
BACKGROUND:Pulmonary hypertension worsens prognosis in patients with heart failure (HF) and secondary mitral regurgitation (SMR). OBJECTIVES: This study sought to determine whether baseline pulmonary hypertension influences outcomes of transcatheter mitral valve repair (TMVr) in patients with HF with SMR. METHODS: In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, 614 patients with HF with moderate-to-severe or severe SMR were randomized to TMVr with the MitraClip plus guideline-directed medical therapy (GDMT) (n = 302) versus GDMT alone (n = 312). Baseline pulmonary artery systolic pressure (PASP) estimated from echocardiography was categorized as substantially increased (≥50 mm Hg) versus not substantially increased (<50 mm Hg). RESULTS: Among 528 patients, 184 (82 TMVr, 102 GDMT) had PASP of ≥50 mm Hg (mean: 59.1 ± 8.8 mm Hg) and 344 (171 TMVr, 173 GDMT) had PASP of <50 mm Hg (mean: 36.3 ± 8.1 mm Hg). Patients with PASP of ≥50 mm Hg had higher 2-year rates of death or HF hospitalization (HFH) compared to those with PASP of <50 mm Hg (68.8% vs. 49.1%; adjusted hazard ratio: 1.52; 95% confidence interval: 1.17 to 1.97; p = 0.002). Rates of death or HFH were reduced by TMVr versus GDMT alone, irrespective of baseline PASP (pinteraction = 0.45). TMVr reduced PASP from baseline to 30 days to a greater than GDMT alone (adjusted least squares mean: -4.0 vs. -0.9 mm Hg; p = 0.006), a change that was associated with reduced risk of death or HFH between 30 days and 2 years (adjusted hazard ratio: 0.91 per -5 mm Hg PASP; 95% confidence interval: 0.86 to 0.96; p = 0.0009). CONCLUSIONS: Elevated PASP is associated with a worse prognosis in patients with HF with severe SMR. TMVr with the MitraClip reduced 30-day PASP and 2-year rates of death or HFH compared with GDMT alone, irrespective of PASP.
Authors: Matti Adam; Elmar Kuhn; Hendrik Wienemann; Victor Mauri; Laurin Ochs; Maria Isabel Körber; Kaveh Eghbalzadeh; Christos Iliadis; Marcel Halbach; Thorsten Wahlers; Stephan Baldus Journal: Clin Res Cardiol Date: 2022-09-15 Impact factor: 6.138