Objective: To evaluate the incidence, predictors and outcomes of female patients with patient-prosthesis mismatch (PPM) following transcatheter aortic valve intervention (TAVI) for severe aortic stenosis (AS). Background: Female AS TAVI recipients have a significantly lower mortality than surgical aortic valve replacement (SAVR) recipients, which could be attributed to the potentially lower PPM rates. TAVI has been associated with lower rates of PPM compared to SAVR. PPM in females post TAVI has not been investigated to date. Methods: The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multicenter registry of women undergoing TAVR for severe symptomatic AS. Two hundred and fifty patients with detailed periprocedural and followup echocardiographic investigations were included in the WIN-TAVI echocardiographic sub-study. PPM was defined as per European guidelines stratified by the presence of obesity. Results: The incidence of PPM in our population was 32.8%. Patients with PPM had significantly higher BMI (27.4 ± 6.1 vs. 25.2 ± 5.0, p = .002), smaller sized valves implanted (percentage of TAVI ≤23 mm 61% vs. 29.2%, PPM vs. no PPM, p < .001) and were more often treated with balloon expandable valves (48.3 vs. 32.5%, p < .001) rather than self expanding ones (26.3 vs. 52.8%, <.001). BMI (OR = 1.08; 95%CI 1.02-1.14, p = .011) and valve size ≤23 mm (OR = 3.00 95%CI 1.14-7.94, p = .027) were the only independent predictors of PPM. There was no significant interaction between valve size and valve type (p = .203). No significant differences were observed in 1-year mortality or major adverse cardiovascular events. Conclusions: PPM in females undergoing TAVI occurs in one third of patients. BMI and valve size ≤23 mm are independent predictors. Larger registries are required to determine the impact of PPM on future clinical outcomes.
The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.
Background Recently the distal radial access (DRA) technique has been introduced for coronary angiography and intervention as an alternative to the conventional radial access (RA). Purpose The aim of this study was to provide a quantitative appraisal of the effects of DRA vs conventional RA for coronary angiography with or without intervention. Methods The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched for randomised clinical trials (RCT) comparing DRA versus RA for coronary angiography and/or intervention. Data were pooled by meta-analysis using a random-effects model. The number of patients needed to treat for an additional beneficial outcome (NNTB) and the number needed to treat for an additional harmful outcome (NNTH) were calculated. The primary endpoint was radial artery occlusion (RAO) at the longest available follow-up. Additional secondary outcomes were assessed. Results A total of 13 RCT including 4,901 patients were identified and included in the final analysis. Coronary angiography alone was performed in 3 studies, percutaneous coronary intervention was performed in a variable proportion of patients ranging from 24% to 100% across studies. Study population included patients with chronic coronary syndrome in the large majority, and the proportion of acute coronary syndrome ranged from to 31% to 100% across studies. Compared with RA, DRA was associated with a significant lower risk of RAO, either detected at the longest follow-up (risk ratio [RR]: 0.36; 95% CI: 0.23 to 0.58; p<0.001, NNTB = 24.5), or in-hospital (RR: 0.32; 95% CI: 0.18 to 0.57; p<0.001, NNTB = 21.5), as well as Early discharge after transradial stenting of coronary arteries (EASY) Scale ≥ II hematoma (RR: 0.46; 95% CI: 0.22 to 0.97; p=0.04, NNTB = 66). By contrast, DRA was associated with a higher risk of access site crossover (RR: 3.43; 95% CI: 1.88 to 6.25, p<0.001, NNTH = 10), a longer time for radial artery puncture (standardized mean difference [SMD]: 3.56; 95% CI: 0.96 to 6.16; p<0.001), and sheath insertion (SMD: 0.38; 95% CI: 0.11 to 0.65, p=0.006), and a higher number of puncture attempts (SMD: 0.59, 95% CI: 0.48 to 0.69, p<0.001). A meta-regression analysis showed that increasing age in the RA group was associated with a reduced effect of DRA, compared with RA, on the risk of RAO. No significant effect of other variables such as the prevalence of female sex, diabetes, smoking status, acute coronary syndrome, and percutaneous coronary intervention was found. Conclusions Compared with RA, DRA is associated with lower risks of RAO and EASY ≥ II hematoma, but requires longer time for radial artery puncture and sheath insertion, more puncture attempts and a higher access site crossover. Funding Acknowledgement Type of funding sources: None.
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