Objectives Differences in terms of safety and efficacy of percutaneous edge-to-edge mitral repair between patients with functional and degenerative mitral regurgitation (MR) are not well established. We performed a systematic review and meta-analysis to clarify these differences. Methods PubMed, EMBASE, Google scholar database and international meeting abstracts were searched for all studies about MitraClip. Studies with <25 patients or where 1-year results were not delineated between MR aetiology were excluded. This study is registered with PROSPERO. Results A total of nine studies investigating the mid-term outcome of percutaneous edge-to-edge repair in patients with functional versus degenerative MR were included in the meta-analysis (n=2615). At 1 year, there were not significant differences among groups in terms of patients with MR grade≤2 (719/1304 vs 295/504; 58% vs 54%; risk ratio (RR) 1.12; 95% CI: 0.86 to 1.47; p=0.40), while there was a significantly lower rate of mitral valve re-intervention in patients with functional MR compared with those with degenerative MR (77/1770 vs 80/818; 4% vs 10%; RR 0.60; 95% CI: 0.38 to 0.97; p=0.04). One-year mortality rate was 16% (408/2498) and similar among groups (RR 1.26; 95% CI: 0.90 to 1.77; p=0.18). Functional MR group showed significantly higher percentage of patients in New York Heart Association class III/IV (234/1480 vs 49/583; 16% vs 8%; p<0.01) and re-hospitalisation for heart failure (137/605 vs 31/220; 23% vs 14%; p=0.03). No differences were found in terms of single leaflet device attachment (25/969 vs 20/464; 3% vs 4%; p=0.81) and device embolisation (no events reported in both groups) at 1 year. Conclusions This meta-analysis suggests that percutaneous edge-to-edge repair is likely to be an efficacious and safe option in patients with both functional and degenerative MR. Large, randomised studies are ongoing and awaited to fully assess the clinical impact of the procedure in these two different MR aetiologies.
19 November 2019 in Journal of the American Heart Association
Background: Management of coronary artery disease in patients undergoing transcatheter aortic valve implantation is uncertain. Fractional flow reserve ( FFR ) has never been clinically validated in aortic stenosis. The study aim was to analyze the clinical outcome of FFR ‐guided revascularization in patients undergoing transcatheter aortic valve implantation. Methods and Results: Patients with severe aortic stenosis and coronary artery disease at coronary angiography were included in this retrospective analysis and divided in 2 groups: angiography guided (122/216; 56.5%) versus FFR ‐guided revascularization (94/216; 43.5%). Patients were clinically followed up and evaluated for the occurrence of major adverse cardiac and cerebrovascular events at 2‐year follow‐up. Most lesions in the FFR group resulted negative according to the conventional 0.80 cutoff value (111/142; 78.2%) and were deferred. The FFR ‐guided group showed a better major adverse cardiac and cerebrovascular event–free survival compared with the angio‐guided group (92.6% versus 82.0%; hazard ratio, 0.4; 95% CI , 0.2–1.0; P =0.035). Patients with deferred lesions based on FFR presented better outcome compared with patients who underwent angio‐guided percutaneous coronary intervention (91.4% versus 68.1%; hazard ratio, 0.3; 95% CI , 0.1–0.6; P =0.001). Conclusions: FFR guidance was associated with favorable outcome in this observational study in patients undergoing transcatheter aortic valve implantation. Randomized trials are needed to investigate the long‐term effects of FFR ‐guided revascularization against angiographic guidance alone in patients with aortic stenosis.
1 March 2019 in Circulation: Cardiovascular Quality and Outcomes
Background: Women account for a large proportion of patients treated with transcatheter aortic valve replacement, yet there remain conflicting reports about the effect of sex on outcomes. Moreover, the sex-specific prevalence and prognostic impact of frailty has not been systematically studied in the context of transcatheter aortic valve replacement. Methods and Results: A preplanned analysis of the FRAILTY-AVR study (Frailty Aortic Valve Replacement) was performed to analyze the determinants of outcomes in older women and men undergoing transcatheter aortic valve replacement. FRAILTY-AVR was a multinational, prospective, observational cohort assembled at 14 institutions in North America and Europe from 2012 to 2017. Multivariable logistic regression models were stratified by sex and adjusted for covariates. Interaction between sex and each of these covariates was assessed. The primary outcome was 12-month mortality, and the secondary outcome was 1-month composite mortality or major morbidity. The cohort consisted of 340 women and 419 men. Women were older and had higher predicted risk of mortality. Women were more likely to have physical frailty traits, but not cognitive or psychosocial frailty traits, and global indices of frailty were similarly associated with adverse events regardless of sex. Women were more likely to require discharge to a rehabilitation facility, particularly those with physical frailty at baseline, although their functional status was similar to men at 12 months. The risk of 1-month mortality or major morbidity was greater in women, particularly those treated with larger prostheses. The risk of 12-month mortality was not greater in women, with the exception of those with pulmonary hypertension, in whom, there was a significant interaction for increased mortality. Conclusions: The present study highlights sex-specific differences in older adults undergoing transcatheter aortic valve replacement and draws attention to the impact of physical frailty in women and their potential risk associated with oversized prostheses and pulmonary hypertension.