TEER safe, effective in high-surgical-risk patients with degenerative mitral regurgitation
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NEW ORLEANS — An analysis of the STS/ACC TVT registry showed that successful transcatheter edge-to-edge repair for degenerative mitral regurgitation was safe and significantly improved symptoms and mortality at 1 year, a speaker reported.
“Transcatheter mitral valve edge-to-edge repair (TEER) is currently FDA approved for degenerative mitral regurgitation in high-surgical-risk patients. The contemporary outcomes of TEER for degenerative [mitral regurgitation] in the real-world setting are less known. We sought to evaluate the trends, procedural and clinical outcomes of TEER for degenerative mitral regurgitation in the real-world [Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy] registry,” Raj R. Makkar, MD, associate director of interventional technologies at Smidt Heart Institute, Cedars-Sinai, said during a presentation at the American College of Cardiology Scientific Session.
The STS/ACC TVT registry is a nationwide database of all consecutive patients undergoing commercial transcatheter mitral valve repair.
The present analysis included 19,088 patients (median age, 82 years; 49% women; median STS Predicted Risk of Mortality score, 4.57%) who underwent nonemergent TEER (MitraClip) between January 2014 and June 2022 for moderate to severe or severe mitral regurgitation due to “pure” degenerative pathology, defined as mitral regurgitation secondary to abnormal leaflets and/or chordae, with leaflets that may prolapse or flail into the left atrium, according to the study.
The primary endpoint was procedural success, defined as post-repair residual mitral regurgitation of moderate, mild or none/trace and absence of severe stenosis. Secondary endpoints included in-hospital, 30-day and 1-year outcomes including death, HF hospitalization and mitral valve reintervention. The researchers also evaluated death and HF rehospitalization, based on residual mitral regurgitation and mitral valve gradients.
At baseline, 17.8% of patients had moderate to severe mitral regurgitation and 82.2% had severe regurgitation.
In-hospital and 30-day incidence of death, unplanned surgery or intervention, stroke/transient ischemic attack and new requirement for dialysis was low (1.1% or less for each outcome).
Makkar reported that the primary endpoint of successful repair at 30 days was achieved in 89% of the cohort and successful repair was associated with reduced risk for mortality (adjusted HR = 0.49; 95% CI, 0.42-0.56; P < .001), HF rehospitalization (aHR = 0.47; 95% CI, 0.41-0.54; P < .001) and mitral valve reintervention at 1 year (aHR = 0.15; 95% CI, 0.12-0.19; P < .001).
Residual mitral regurgitation and mitral gradients were associated with increased risk for 1-year mortality and HF readmission, with the best outcomes observed among patients with mild or less residual mitral regurgitation and no mitral stenosis after TEER (log-rank P for both < .0001), Makkar and colleagues found.
Moreover, the procedural volume and success rate increased during the 8-year study period, according to the study.
“In this national registry analysis of more than 19,000 patients undergoing TEER with the MitraClip device for degenerative mitral regurgitation, the safety profile was excellent despite advanced age and significant comorbidities,” Makkar said during the presentation. “Transcatheter mitral valve repair with the MitraClip device is a safe and effective treatment for degenerative [mitral regurgitation] patients who are at elevated risk for surgery. The goal of transcatheter mitral valve repair for degenerative [mitral regurgitation] should be to achieve mild or less residual [mitral regurgitation], without creating significant mitral stenosis.”
Perspective
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This study is basically a multiyear analysis of real-world registry data of how MitraClip is performing.
The encouraging part was that it seemed to be very safe across the board, with very low, single-digit complication rates and very high improvement in symptomatology for those patients, with postprocedural and discharge success rates above 90%, where patients were able to become less symptomatic or were even able to no longer be short of breath with activity, or certainly not to the degree they had been previously.
It was a long-term win for transcatheter edge-to-edge repair, which was done safely with a low complication rate, a low chance of needing any kind of emergency surgery or any worse outcomes and a high success rate more than 90%, where patients symptomatically felt much better.
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Makkar RR, et al. Featured Clinical Research II. Presented at: American College of Cardiology Scientific Session; March 4-6, 2023; New Orleans (hybrid meeting).
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