Transcatheter mitral valve repair may benefit in secondary MR outside current indication
Click Here to Manage Email Alerts
Certain patients with HF and secondary mitral regurgitation outside the current indication for transcatheter mitral valve repair benefited from the procedure, according to results of the MitraClip Global EXPAND Study.
As Healio previously reported, in the COAPT trial, patients with HF and moderate to severe or severe functional mitral regurgitation (MR) who had transcatheter mitral valve repair (MitraClip, Abbott) plus medical therapy had reduced risk for HF hospitalization and mortality compared with those who had medical therapy alone. As a result, the FDA in 2019 granted an expanded indication for the device to treat patients who met the inclusion criteria for COAPT.
For the EXPAND real-world cohort study, presented at TVT: The Structural Heart Summit by Gilbert Tang, MD, MSc, MBA, surgical director for the Structural Heart Program and professor of cardiovascular surgery at Icahn School of Medicine at Mount Sinai, the researchers analyzed outcomes of patients with HF and secondary MR outside the COAPT criteria who had transcatheter mitral valve repair with the MitraClip NTR or XTR device.
“We have very little knowledge of what happens with real-world patients who received MitraClip for secondary MR that may have fallen out of COAPT criteria,” Tang told Healio. “The EXPAND registry may be able to answer some of those questions.”
The analysis included 125 patients (mean age, 75 years; 65% men) classified as COAPT-like (defined as moderate-severe to severe MR by core lab, left ventricular ejection fraction 20% to 50%, LV end-systolic diameter [LVESD] 70 mm and systolic pulmonary artery pressure [PAP] 70 mm Hg), 128 patients (mean age, 75 years; 55% men) classified as non-COAPT-like with moderate MR (defined as moderate MR by core lab and at least one of LVEF 20%, LVESD 70 mm or systolic PAP 70 mm Hg) and 32 patients (mean age, 75 years; 69% men) classified as non-COAPT-like with advanced HF (defined as moderate-severe to severe MR by core lab with at least one of LVEF < 20%, LVESD > 70 mm or systolic PAP > 70 mm Hg).
Patients similar to those from the MITRA-FR trial, which was negative, were excluded; these patients had moderate MR by core lab and LVEF less than 20%, LVESD greater than 70 mm or systolic PAP greater than 70 mm Hg, Tang told Healio. Also excluded were patients with moderate-severe to severe MR by core lab and LVEF greater than 50%, he said.
At 1 year, reduction of MR to mild or better was achieved in 86.5% of the COAPT-like group (P < .001), 97.2% of the non-COAPT-like with moderate MR group (P < .001), and 81.3% of the non-COAPT-like with advanced HF group (P = .13), Tang said during the presentation.
“The 1-year MR reduction was actually better than that achieved in COAPT, even in the advanced HF group,” Tang told Healio. “It is very encouraging that MitraClip therapy has become excellent in MR reduction to [mild] or less in the overwhelming majority of the patients from a real-world registry.”
Improvement to NYHA class I or II HF at 1 year was achieved in the majority of all three groups (P < .0001 for the COAPT-like and non-COAPT-like with moderate MR groups; P = .0002 for the non-COAPT-like with advanced HF group), he said.
In addition, he said, Kansas City Cardiomyopathy Questionnaire (KCCQ) score improved over 1 year in the COAPT-like and non-COAPT-like with moderate MR groups (P for both < .0001) and trended toward improvement in the non-COAPT-like with advanced HF group (P = .07).
The 1-year mortality rates did not differ between the COAPT-like and non-COAPT-like with moderate MR groups (COAPT, 22.6%; no COAPT, 19.6%, log-rank P = .37) and the 1-year HF hospitalization rates numerically favored the non-COAPT-like with moderate MR group (32.6% vs. 25%; log-rank P = .08), he said.
There were no differences in 1-year mortality and HF hospitalization between the COAPT-like group and the non-COAPT-like with advanced HF group (mortality: COAPT, 22.6%; no COAPT, 22.8%; log-rank P = .93; HF hospitalization, COAPT, 32.6%; no COAPT, 24.5%; log-rank P = .33), according to the researchers.
“A percentage of the EXPAND patients came from outside the United States, and only about 30% met the COAPT criteria,” Tang told Healio. “We can show that at 1 year, hospitalization and mortality are not worse [for those not meeting COAPT criteria], they have sustained MR reduction to mild or less and functional improvement in terms of NYHA class and KCCQ score.”
More needs to be determined about the effect of guideline-directed medical therapy, which is better now than it was when the COAPT trial was conducted, Tang said in an interview.
“The needle is still moving in terms of what therapy better benefits these patients, but using the MitraClip and the ability to reduce MR to mild or less certainly has some benefits,” he said.
For more information:
Gilbert Tang, MD, MSc, MBA, can be reached on Twitter at @gilberttangmd.
Collapse
Tang G, et al. Late-Breaking Clinical Science. Presented at: TVT: The Structural Heart Summit; June 8-10, 2022; Chicago (hybrid meeting).
Click Here to Manage Email Alerts