PCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) issued a statement at EuroPCR 2019 (20–24 May, Paris, France) outlining the role of percutaneous edge-to-edge repair in the management of heart failure and secondary mitral regurgitation.
Bernard Prendergast (St. Thomas’ Hospital, London, UK) announced the statement, explaining: “The place of edge-to-edge repair in the armamentarium of physicians involved in the care and management of patients with heart failure requires assimilation alongside the alternatives of resynchronisation therapy, surgery, and other transcatheter techniques. Importantly the timing of these interventions in the natural history of mitral regurgitation requires further assessment in an attempt to interrupt the progressive cycle of left ventricular dilatation and increasing degrees of mitral regurgitation.”
The prevalence of mitral regurgitation is expected to double in the next two decades as a result of the ageing population. He described it as an “ominous prognosis”, and said: “The stage is set for transcatheter treatment options.” Referencing the publication in 2018 of conflicting findings from the COAPT and MITRA-FR trials, he added: “Last year, the landscape changed … with potential impact for future guidelines.”
“In essence, patients in COAPT had more mitral regurgitation but smaller left ventricles,and were receiving optimal guideline-directed medical treatment before randomisation, in contrast with MITRA-FR where therapy was adopted following clip implantation. And, arguably, the techniques of MitraClip implantation were superior in COAPT, with better acute results, lower rates of procedural complications and less mitral regurgitation at one-year echocardiographic follow-up. The results of COAPT can take their place alongside the existing evidence base supporting medical treatment, and, to a lesser extent, cardiac resynchronisation. The potential impact on treatment worldwide is considerable.”
The position statement recommends early referral for those with symptomatic heart failure and moderate to severe mitral regurgitation to a multidisciplinary heart team which should evaluate and optimise medical therapy and consider the roles of device therapy, transcatheter mitral intervention and, where appropriate, surgery. The heart team should consist of valve intervention specialists, valve surgeons, heart failure specialists, valve imaging specialists, and electrophysiologists.
“Based on the results of COAPT, transcatheter edge-to-edge repair is appropriate in these carefully selected patients who remain symptomatic despite optimal treatment,” Prendergast declared. “And the inclusion criteria of COAPT are to be firmly adhered to, to allow judicious and evidence-based application of this technology.”
The statement also suggests that surgical treatment of secondary mitral regurgitation should be considered in patients with concomitant coronary artery disease who are undergoing surgical revascularisation, and that circulatory support devices and cardiac transplantation may be an alternative for patients with extreme left ventricular and/or right ventricular failure. The role of other transcatheter treatment options remains under investigation.
“Lastly, and perhaps most importantly,” said Prendergast, “we need to remember that futile expensive interventions should be avoided in patients with short life expectancy, arbitrarily defined as less than one year. In these patients, access to appropriate support and specialist palliative care is a more appropriate treatment direction.”
The statement provides a platform for a joint position statement with the EAPCI, European Heart Rhythm Association, European Association of Cardiovascular Imaging, and the Heart Failure Association, that is currently under review by the European Heart Journal.
Also at EuroPCR, Francesco Bedogni (IRCCS Policlinica, San Donato, Milan, Italy), presented one-year results from GIOTTO (GISE registry of transcatheter treatment of mitral valve regurgitation), an ongoing single-arm, observational, multicentre prospective registry with 1,348 participants in 21 Italian centres.
Enrolment began in February 2016, and it aims to collect real-world epidemiological, procedural and clinical data on early and long-term outcomes following percutaneous edge-to-edge mitral regurgitation therapy, with follow-up at 30 days and then yearly up to five years. Mean age is 75±9 years, and 64.5% are male.
The procedural success rate was 95.1%, with 3% deaths at 30 days. Overall mortality was 17.8%, and cardiac mortality was 10.5% at one-year. The hospitalisation rate was 27.1%, and hospitalisations for heart failure were 9% at one year.
The clinical features of the GIOTTO population are closer to those of COAPT trial than MITRA-FR, and reported similar outcomes. “It is very interesting that [this] real world population with similar baseline characteristics to the COAPT trial has similar results,” Bedogni said.