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Transcatheter mitral valve replacement ineligibility confers worse outcomes
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Patients ineligible for transcatheter mitral valve replacement and treated medically were more likely to have poor outcomes, according to a study published in JACC: Cardiovascular Interventions.
“Taken together, these findings suggest that addressing the causes for [transcatheter mitral valve replacement] ineligibility will be required to improve the outcomes of patients with [mitral regurgitation] regardless of whether they do or do not undergo [transcatheter mitral valve replacement],” Hiroki Niikura, MD, research scholar at the Valve Science Center of the Minneapolis Heart Institute at Abbott Northwestern Hospital, and colleagues wrote.
Researchers analyzed data from 203 patients (mean age, 79 years; 48% men) from early feasibility studies of transcatheter mitral valve replacement who were ineligible for the procedure due to primary or secondary etiologies or high or prohibitive surgical risk. Medical records were reviewed for information on symptom status, patient demographics, procedural therapy, morbidities and clinical outcomes.
Causes for ineligibility were categorized as anatomic or procedural impediments, clinical criteria or the presence of medical futility. Medical futility was defined as the presence of severe dementia or mental illness, excessive frailty, severe liver disease, severe lung disease, life-threatening malignancy and end-stage renal disease or dialysis treatment. Frailty was assisted by a multidisciplinary heart team. In addition, researchers calculated the risk for mortality and surgical risk.
Primary clinical outcomes of interest were defined as hospitalization for HF and mortality at 1-year follow-up.
During a median follow-up of 214 days, 89% of patients were ineligible for transcatheter mitral valve replacement. The most common reasons for ineligibility were severe tricuspid regurgitation (15.3%), excessive frailty (15.3%) and prior aortic valve therapy (14.2%).
Mitral anatomic exclusions were seen in 15.8% of patients. Although the risk for left ventricular outflow tract obstruction was infrequent (4.4%), severe annular calcification was seen in 7.4% of patients.
Subsequent commercial survival or transcatheter mitral therapy was not performed in 37.4% of patients. At 1 year, patients who were not eligible for transcatheter mitral valve replacement and were not treated commercially had increased rates for death or HF hospitalization (22.4%). This was also seen for cardiac death (11.8%). Compared with patients who underwent surgery, those who did not have surgery had higher rates of cardiac death (2.4%; P < .001) and HF hospitalization (5.5%; P = .003). This continued to be worse after the exclusion of patients with medical futility or excessive frailty and adjustment for baseline differences.
“These data and the high rate of [transcatheter mitral valve replacement] ineligibility support the need for further therapy iteration as well as development of alternative means, with the goal of improving the prognosis of these patients,” Niikura and colleagues wrote. – by Darlene Dobkowski
Disclosures: Niikura reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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