Patients with heart failure (HF) and severe secondary mitral regurgitation (SMR) with elevated pulmonary artery systolic pressure (PASP) were at higher risk for rehospitalization and death, however valve repair somewhat mitigated the risks. These findings, from a multicenter, randomized, controlled, open-label trial, were published in the Journal of the American College of Cardiology.
Patients (N=614) with HF were randomly assigned to receive guideline-directed medical therapy (GDMT; n = 312) alone or with transcatheter mitral valve repair (TMVr) with a MitraClip device (n = 302) at 78 centers in the United States and Canada between 2012 and 2017. Patients were followed through 2 years (median, 24.0 months) and assessed by echocardiograph, for PASP, and clinical outcomes.
Patients were aged mean 72.1 (±11.5) years, 63.1% were men, and the average left ventricular ejection fraction was 31.6% (±9.4%). Baseline PASP was not normally distributed, with a median value of 43.1 mmHg (interquartile range [IQR], 34.0-53.0), and 34.8% of patients had substantially elevated PASP (³50 mmHg).
Patients with substantially elevated PASP were more likely to have increased severe mitral regurgitation (59.2% vs 44.5%; P =.0019) and moderate tricuspid regurgitation (24.7% vs 12.9%; P =.006).
Death or hospitalization due to HF was significantly elevated at 2 years among patients with elevated PASP (adjusted hazard ratio [aHR], 1.52; 95% CI, 1.17-2.97; P =.002) as were mortality (aHR, 1.57; 95% CI, 1.14-2.16; P =.006), cardiovascular death (aHR, 1.70; 95% CI, 1.19-2.45; P =.004), and HF hospitalization (aHR, 1.46; 95% CI, 1.08-1.97; P =.02).
The investigators observed that with every 10-mmHg increase of PASP, an 18% increase of 2-year risk for death or hospitalization due to HF was observed (aHR, 1.18; 95% CI, 1.08-1.30; P =.0004), regardless of treatment assignment.
Patients who were assigned to receive GDMT plus TMVr had a lower risk for death or hospitalization due to HF among patients with both low PASP (aHR, 0.59; 95% CI, 0.42-0.82) and high PASP (aHR, 0.48; 95% CI, 0.32-0.72).
The difference between treatment groups was observed as early as 1 month, at which time patients who received GDMT plus TMVr had a paired least squares mean change in PASP of -4.0 (±0.8) mmHg compared with -0.9 (±0.8) mmHg among those who received GDMT alone (group difference, -3.1±1.1 mmHg; P =.006).
The risk for adverse events at 2 years associated with a 5-mmHg decrease in PASP at 30 days was significantly reduced for death or hospitalization from HF (aHR, 0.91; 95% CI, 0.86-0.96; P =.0009) and hospitalization from HF (aHR, 0.90; 95% CI, 0.85-0.96; P =.002).
The gold standard for assessing PASP is by right heart catheterization. This method was not used for this study, possibly limiting its findings.
These data indicated patients with progressively worse PASP were at increased risk for poorer clinical outcomes and mortality. TMVr with MitraClip and GDMT reduced, more than GDMT alone, risk for death and rehospitalization from HF.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of authors’ disclosures.
Ben-Yehuda O, Shahim B, Chen S, et al. Pulmonary hypertension in transcatheter mitral valve repair for secondary mitral regurgitation. The COAPT trial. J Am Coll Cardiol. 2020;76(22):2595–2606. doi:10.1016/j.jacc.2020.09.609