NEW ORLEANS — Patients who received the MitraClip device to treat heart failure with secondary mitral regurgitation showed significant and lasting improvements on a quality-of-life assessment compared to people treated with optimal medical therapy alone, according to a substudy of the COAPT trial presented at the American College of Cardiology’s scientific sessions.
The study was also published simultaneously in the Journal of the American College of Cardiology.
Lead author Suzanne Arnold, MD, with Saint Luke’s Mid America Heart Institute, and colleagues studied health status outcomes of 302 patients randomized to transcatheter mitral valve repair (TMVR) with the MitraClip and 312 patients randomized to standard treatment. The average score on the Kansas City Cardiomyopathy Questionnaire at baseline was 52 out of 100, representing a significantly impaired quality of life in which heart failure symptoms would lead to shortness of breath during light housework and difficulties performing activities of daily living.
But after one month, patients in the TMVR arm improved their KCCQ scores by an average of 15.9 points beyond those on standard therapy. Two years later, that margin had only slightly narrowed, to a difference of 12.8 points.
The minimum gap for a “clinically important change” is about 2.5 points, the authors wrote, suggesting MitraClip therapy significantly and lastingly improved patients’ quality of life.
“When we talk to patients, it’s not that they just want to live longer, they want to live better,” said Janet Wyman, DNP, APRN, manager for the Center for Structural Heart Disease at Henry Ford Hospital in Detroit, who wasn’t involved in the study. “And there’s a conscious effort in this study to look at how are we impacting, not just in the 30 days or one year after (the procedure) but looking for a longer time of, ‘Is this going to be a durable change?’”
“The durability of the finding was a bit surprising given that these patients had pretty severe heart failure at baseline,” Arnold said in a press release. “You might expect that the benefit might wane over time, and the fact that we didn’t see much reduction over time was encouraging.”
Another COAPT substudy at ACC.19 looked at how echocardiography is helpful both in assessing patients before a MitraClip implantation and also evaluating the success of the procedure. Researchers are continuing to unpack the COAPT data as they look to replicate the trial’s positive outcomes in the real world—an issue that’s even more important now that the FDA has expanded the device’s indication to include patients with secondary mitral regurgitation.
Arnold et al. noted there were limited health status data collected in MITRA-FR, another MitraClip study which wasn’t as positive as COAPT, so it remains important to continue assessing quality of life in these patients. This is particularly relevant for real-world patients who wouldn’t have met the stringent inclusion criteria of COAPT, the authors wrote.
Another limitation of the study was that severely ill patients were the most likely to die during follow-up, which could have boosted the average quality of life among survivors at later time points. Nevertheless, the authors were encouraged with the results of their substudy.
“Considering the previously reported benefits of TMVR on survival and (heart failure) hospitalization, these health status findings further support TMVR as a valuable treatment option for HF patients with severe secondary MR who remain symptomatic despite maximally tolerated guideline-directed medical therapy,” Arnold and co-authors wrote in JACC.
Abbott, the manufacturer of the MitraClip, funded COAPT and its substudies.