Predictors of clinical outcome in transfemoral TAVI: circumferential iliofemoral calcifications and manufacturer-derived recommendations.

OBJECTIVE: This study aimed to investigate the predictive value of circumferential iliofemoral calcifications and current manufacturer recommendations, which are not evidence-based, in transfemoral (TF) transcatheter aortic valve implantation (TAVI). METHODS: A patient cohort with a broad range of iliofemoral anatomies undergoing TF TAVI (n=132) were retrospectively divided as "suitable" (n=76, 58%) and "unsuitable" (n=56, 42%) candidates according to current recommendations. Iliofemoral angiography and reconstructed multislice CT (MSCT) images were used for access screening in the majority of patients. RESULTS: Vessel properties were significantly worse in the "unsuitable group." The sheath-to-iliofemoral artery ratio (SIFAR) and calcium score were 1.35±0.2 and 1.7±0.8 in the unsuitable group, compared to 1.0±0.12 (p<0.0001) and 1.0±0.7 (p=0.0001) in the "suitable" patients. Major vascular complications (MVCs) occurred more frequently in the "unsuitable" group (10.7% vs. 2.6%, p=0.07) and were predicted by SIFAR [OR: 64, 95% CI: 1.4-2971, p=0.03] and circumferential iliofemoral calcifications [OR: 6, 95% CI: 1.2-26, p=0.025]. In the multivariate analysis, circumferential calcifications [HR: 3.6, 95% CI: 1-13.2, p=0.043] but not major vascular complications (MVCs) or manufacturer recommendations were associated with increased mortality. CONCLUSION: According to our results, manufacturer recommendations are safe but overly conservative. Circumferential iliofemoral calcifications may provide independent prognostic information in patients undergoing TAVI.

Stroke prevention by percutaneous closure of patent foramen ovale: a systematic review and meta-analysis.

CONTEXT: The role of percutaneous closure of patent foramen oval (PFO) in patients with cryptogenic stroke has been very controversial for years due to a lack of clear evidence. OBJECTIVE: Systematic review and meta-analysis of the effect of percutaneous PFO closure for secondary prevention of cryptogenic strokes as compared to best medical therapy (BMT). DATA SOURCES: Trials were identified through a literature search until 28 May 2013. STUDY SELECTION: Controlled clinical trials (randomised and non-randomised) comparing percutaneous PFO closure with BMT. DATA EXTRACTION AND SYNTHESIS: Main end point of interest was stroke. A random effects model was used to calculate the pooled relative risks (RR) with 95% CIs. RESULTS: A total of 14 studies (three randomised controlled trials (RCT) and 11 non-randomised observational studies (non-RCT)), and a total of 4335 patients were included for this analysis. There was no significant treatment effect of PFO closure regarding stroke among the RCT (RR 0.66, 95% CI 0.37 to 1.19, p=0.171). However, among non-RCT stroke was reduced (RR 0.37, 95% CI 0.20 to 0.67, p<0.001) after PFO closure. A time-to-event (stroke) analysis, combining all three RCT and the two non-RCT which applied strict multivariate adjustments, showed a borderline significant risk reduction after PFO closure (HR 0.58, 95% CI 0.33 to 0.99, p=0.047). Neither risk of bleeding nor mortality differed significantly between the groups. However, there was a higher incidence of new onset atrial fibrillation in the closure group (RR 3.50, 95% CI 1.47 to 8.35, p=0.005). CONCLUSIONS: Percutaneous closure of PFO in patients with cryptogenic stroke does not appear superior to medical therapy according to currently available randomised data. Furthermore, it is associated with an increased incidence of atrial fibrillation. However, there are signals pointing towards a potential benefit and more research should be strongly encouraged.

Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials.

CONTEXT: The optimal treatment option for in-stent restenosis is currently unclear. OBJECTIVE: Systematic review and meta-analysis of the effect of drug-eluting balloons (DEB) to treat in-stent restenosis. DATA SOURCES: Trials were identified through a literature search from 2005 through 7 November 2012. STUDY SELECTION: Randomised clinical trials comparing DEB with a control treatment (plain balloon angioplasty or drug-eluting stents). DATA EXTRACTION AND SYNTHESIS: Main endpoints of interest were major adverse cardiac events (MACE), target lesion revascularisation (TLR), binary in-segment restenosis, stent thrombosis (ST), myocardial infarction (MI) and mortality. A random-effects model was used to calculate the pooled relative risks (RR) with 95% CIs. RESULTS: Five studies and a total of 801 patients were included in this analysis. Follow-up duration ranged from 12 to 60months. Most endpoints were significantly reduced for DEB compared with the control groups. For MACE, the relative risk RR was 0.46 (0.31 to 0.70), p<0.001, for TLR it was 0.34 (0.16 to 0.73); p=0.006, for angiographic in-segment restenosis it was 0.28 (0.14 to 0.58); p<0.001. There was a lower mortality for DEB (RR 0.48 (0.24 to 0.95); p=0.034). The incidence of MI was numerically lower, but the differences were not statistically significant (RR 0.68 (0.32 to 1.48); p=0.337). There was no difference in the risk of ST (RR 1.12 (0.23 to 5.50), p=0.891). CONCLUSIONS: In-stent restenosis is the bane of coronary angioplasty, and drug-eluting balloon angioplasty is a promising treatment option in this situation. It reduces the risk for MACE compared with plain balloon angioplasty or implantation of a Taxus Liberte drug-eluting stent.