Slovut, David P.

AbstractObjectivesTo summarize the published data of combined transcatheter aortic and mitral valve intervention (CTAMVI).BackgroundCTAMVI, a combination of either transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve‐in‐valve (TAViV) and transcatheter mitral valve replacement (TMVR), transcatheter mitral valve‐in‐valve/valve‐in‐ring (TMViV/ViR), or percutaneous mitral valve repair (PMVR) is an attractive alternative in high‐surgical risk patients with combined aortic and mitral valve disease. However, its procedural details and clinical outcomes have not been well described.MethodsWe performed a systematic review of all the published articles from PUBMED and EMBASE.ResultsA total of 37 studies with 60 patients were included. The indication for CTAMVI was high or inoperable surgical risk and symptomatic severe aortic stenosis (92%) or severe aortic regurgitation (8%) combined with moderate to severe/severe mitral stenosis (30%) or moderate/severe mitral regurgitation (65%) or both (5%). In majority of the cases, aortic valve intervention was performed prior to the mitral valve. Mortality rate were 25% for TAVR + TMVR (range 42 days to 10 months), 17% for TAVR + TMViV/ViR (range 13 days to 6 months), 0% for TAViV + TMViV/ViR (range 6–365 days), and 15% for TAVR/ViV + PMVR (range 17 days to 419 days). Significant (more than moderate) paravalvular regurgitation post‐procedure was rare.ConclusionsCTAMVI appears to confer reasonable clinical outcome. Further large study is warranted to clarify the optimal strategy, procedural details and clinical outcomes in the future.

AbstractBackgroundTranscatheter aortic valve replacement (TAVR) is typically performed under general anesthesia (GA). However, there is increasing data supporting the safety of performing TAVR under local anesthesia/conscious sedation (LA). We performed a meta‐analysis to gain better understanding of the safety and efficacy of LA versus GA in patients with severe aortic stenosis undergoing TAVR.Methods and ResultsWe comprehensively searched EMBASE, PubMed, and Web of Science. Effect sizes were summarized using risk ratios (RRs) difference of the mean (DM), and 95% CIs (confidence intervals) for dichotomous and continuous variables respectively. Twenty‐six studies and 10,572 patients were included in the meta‐analysis. The use of LA for TAVR was associated with lower overall 30‐day mortality (RR, 0.73; 95% CI, 0.57–0.93; P = 0.01), use of inotropic/vasopressor drugs (RR, 0.45; 95% CI, 0.28–0.72; P < 0.001), hospital length of stay (LOS) (DM, −2.09; 95% CI, −3.02 to −1.16; P < 0.001), intensive care unit LOS (DM, −0.18; 95% CI, −0.31 to −0.04; P = 0.01), procedure time (DM, −25.02; 95% CI, −32.70 to −17.35; P < 0.001); and fluoroscopy time (DM, −1.63; 95% CI, −3.02 to −0.24; P = 0.02). No differences were observed between LA and GA for stroke, cardiovascular mortality, myocardial infarction, permanent pacemaker implantation, acute kidney injury, paravalvular leak, vascular complications, major bleeding, procedural success, conduction abnormalities, and annular rupture.ConclusionOur meta‐analysis suggests that use of LA for TAVR is associated with a lower 30‐day mortality, shorter procedure time, fluoroscopy time, ICU LOS, hospital length of stay, and reduced need for inotropic support.

FiberNet® is a second generation non-conventional embolization protection device (EPD) that purports to offer several advantages: ability to capture debris as small as 40 μm, more flexibility with placement and positioning in curved segments requiring a small landing zone, ability to conform to asymmetric vessels, and improved deliverability. The design features a low profile with large surface area to capture debris. Legitimate concerns include inducement of obstruction or low flow with debris capture and requirements in the IFU to aspirate during re-capture and device removal. Our goal was to compare the results of carotid artery stenting (CAS) using FiberNet® against a multi-center experience of CAS using other filter devices to identify any differences in technical success or event rates. FiberNet® (n=25) results were compared to all CAS cases performed at the Mayo Clinic in Rochester, MN, St Mary's/Duluth Clinic in MN, and North Central Heart Institute in Sioux Falls, SD (n=250) from March 2001 to December 2008. Chi-square or means were used to compare variables, as appropriate. Bivariate logistic regression was used to identify possible correlates of adverse outcome. Statistical significance was set at < 0.05. FiberNet® patients were more likely to be older (78.1+5.4 vs 73.6+9.4, p=0.019), female (48% vs 29%, p=0.047), and have peripheral vascular disease (84.0% vs 37.2%, p=0.025), and less likely to have diabetes (8.0% vs 29.8%, p=0.012) than patients in the comparison group. FiberNet® patients had more lesion calcification (40.0% vs 18.9%, p=0.014) and increased number of type 2 and 3 arches (44.2% vs 73.9%, p=0.006). Procedural success rate was 100% in both groups. None of the FiberNet® patients showed evidence of stagnant flow. The thirty-day outcome for TIA, CVA, or death was 4% in FiberNet® versus 4.8% in the comparison group (p NS). None of the independent variables – age gender, serum creatinine, arch complexity, lesion length, lesion calcium, lesion thrombus, PVD, diabetes, contralateral carotid occlusion, or ipsilateral carotid endarterectomy – predicted adverse events. Although FiberNet® patients had more lesion calcium and more challenging arch anatomy, procedural success and adverse events were comparable between groups. The advantages of FiberNet® can be applied to CAS with good technical results and may be a promising EPD for certain high-risk situations.