Experts Debate Mitral Valve Repair, Replacement for Intermediate-Risk Patients

A spirited debate on Sunday revolved around the question of whether MitraClip should be offered to immediate-surgical-risk patients with primary mitral regurgitation (MR) and optimal anatomy for the therapy. 

According to Saibal Kar, MD, of the Heart Institute at Cedars-Sinai Medical Center, Los Angeles, Calif., the answer is yes. 

Presenting a case, Kar argued in favor of mitral valve repair in an 82-year-old woman who presented with dyspnea, no major surgical risk factors, STS score for replacement of 6.5% and STS score for repair of 4%. Kar said he performed a MitraClip (Abbott Vascular) procedure on this patient because it was safer than surgery and the patient had suitable anatomy. 

He backed his argument in favor of MitraClip in this population based on several points. First, he said MitraClip is safer and associated with low vascular complications and stroke vs. surgery in those with suitable anatomy. Additionally, the device is repositionable and removable, leaflets are not resected, annular function is preserved and there is evidence of durability.

He also referenced the EVEREST II study. At 5 years, Kaplan-Meier analysis found freedom from mortality of 81.2% with MitraClip vs. 79% with surgery and freedom from surgery in the MitraClip group or reoperation in the surgery group of 74.3% vs. 92.5%, respectively. Data from EVEREST II REALISM, a continued-access registry of EVEREST II, showed that repair with MitraClip achieved similar reductions in MR and improvements in functional class at 1 year, regardless of surgical risk, Kar added.

However, taking a different stance, Michael Argenziano, MD, of NewYork-Presbyterian/Columbia University Medical Center, New York, N.Y., argued in favor of mitral valve surgery over MitraClip in this population.

“The two categories of patients for whom I have been an advocate of [mitral valve surgery] are high-risk patients and low-risk patients with functional MR — the kind of MR for which surgical repair doesn’t have a good track record of durability because of the pathology of the disease,” he said.

Argenziano reported he has operated on about 20 patients with failed MitraClip devices, most of which were successfully repaired. “But, there is no question in my mind that [some] become unrepairable because even though the clip is usually placed on the segment of the posterior leaflet that is prolapsing, the anterior leaflet is most often normal. … Especially now in the era of multiple clip deployments, there are often bystander chords that are entrapped in those clips,” he explained, adding that he has seen cases where the tissue needed to be resected and could not be repaired.

Argenziano argued that if surgical repair of a failed MitraClip is a reliable low-risk procedure, then the therapy should be considered as the first option.

Kar asserted that the time has come for “a proper randomized study of intermediate-risk patients with good pathology” who can be treated with either surgery or MitraClip.

Disclosures: 

• Argenziano reports no relevant conflicts of interest. 
• Kar reports relationships with multiple pharmaceutical and medical device companies.