TEER noninferior to surgery in patients with heart failure, mitral regurgitation
Click Here to Manage Email Alerts
Key takeaways:
- Transcatheter edge-to-edge repair was as effective as mitral valve surgery in patients with HF and mitral regurgitation at 1 year.
- There were fewer 30-day safety events in the TEER group.
In patients with HF and secondary mitral regurgitation, transcatheter edge-to-edge repair was noninferior to mitral valve surgery for efficacy and was linked with fewer safety endpoint events, according to data from the MATTERHORN trial.
MATTERHORN, presented at the European Society of Cardiology Congress and simultaneously published in The New England Journal of Medicine, was an investigator-initiated study of 210 patients with HF and secondary mitral regurgitation (mean age, 71 years; 40% women; mean left ventricular ejection fraction, 43%) who were symptomatic despite optimal medical therapy. Patients were randomly assigned to undergo transcatheter edge-to-edge repair (TEER) with a mitral valve repair system (MitraClip, Abbott Vascular) or surgical mitral valve repair or replacement. Patients with LVEF less than 20% were excluded.
“We know that [mitral regurgitation] is associated with adverse outcomes in patients with heart failure; it more or less doubles the mortality of these patients,” Volker Rudolph, MD, director of the department of general and interventional cardiology and angiology at the Heart and Diabetes Center NRW, Bad Oeynhausen, Germany, said during a press conference. “We have seen in previous studies that treatment of this condition with transcatheter edge-to-edge repair can improve the prognosis of these patients. However, current European guidelines still recommend transcatheter edge-to-edge repair in these patients only if they are not eligible for surgery, somehow inferring that surgery would be the procedure of choice. This motivated us to perform our study.”
Rudolph and colleagues found no significant difference between the groups in the primary efficacy endpoint of death, hospitalization for HF, mitral valve reintervention, implantation of an assist device or stroke at 1 year (TEER, 16.7% vs. surgery, 22.5%; OR = 0.69; 95% CI, 0.33-1.44; P for noninferiority < .001).
However, the primary safety outcome of major adverse events — which included death, MI, major bleeding, stroke or transient ischemic attack, rehospitalization, reintervention, nonelective CV surgery, renal failure, deep wound infection, mechanical ventilation for more than 48 hours, gastrointestinal complication requiring surgery, new-onset atrial fibrillation, septicemia or endocarditis — at 30 days favored the TEER group (14.9% vs. 54.8%; P < .001), according to Rudolph.
“We think these results may present an indication for interventional mitral repair to patients with secondary mitral regurgitation who are actually eligible for surgery,” he said at the press conference.
Reference:
Perspective
Back to Top
David J. Moliterno, MD, FACC, FACP, FAHA, FESC, FSCAI
This is the beginning of an open challenge to consider patients for either surgical or percutaneous valve repair. On one side, the critics will have plenty of fodder to say it’s too small of a study, it was only done in German centers, it did not have the greatest surgical outcomes and it took 7 years just to enroll about 200 patients, so that may make it a very select population. On the flip side, the results are pretty unarguable. By design, it was a wide confidence interval for noninferiority, but it wasn’t even approached closely, and in fact numerically, most of the results favored the percutaneous approach.
This study will rationalize pursuing the question further. Clearly, it is going to take a larger, multinational, randomized study where the heart team agrees that patients are valid candidates for either a percutaneous or a surgical approach, but I think this is the evidence to justify it. I liken it to the early days of comparing percutaneous vs. surgical coronary intervention, where both sides have stones to throw. The surgeons will say, we do it once, the patients are fine, whereas you have to go back and reintervene on the valve. The interventional cardiologists will say, yes, but at the end of the day (or year), the mortality does not change according to the approach, and the patients don’t want to have the physical cost of an open surgical procedure.
Collapse
Rudolph V, et al. Hot line 3. Presented at: European Society of Cardiology Congress; Aug. 30-Sept. 2, 2024; London (hybrid meeting).
Click Here to Manage Email Alerts