Citations

AbstractObjectiveThe aim of this study was to perform a systematic review and meta‐analyses of observational studies of transcatheter aortic valve replacement (TAVR) for bicuspid aortic valve stenosis (BcAV).BackgroundTAVR for BcAV stenosis has been associated with an increased incidence of paravalvular leaks, valve malposition, pacemaker placement and all‐cause mortality. The conclusions drawn have been limited by small sample sizes. The use of TAVR for BcAV stenosis remains controversial.MethodsWe searched multiple databases from the inception of the databases through September 30, 2016 for studies of TAVR for BcAV stenosis. We included all observational studies with more than one patient and at least 1 month of outcomes.ResultsWe analyzed 13 observational studies with 758 patients. Meta analyses showed device success rate of 95% [95% confidence interval (CI) 90.2% to 98.5%] and an early safety event in 16.9% [95% CI 12.2% to 22%]. At 30 days, moderate to severe paravalvular leak was seen in 12.2% [95% CI 3.1% to 24.8%] and new pacemaker implantation in 17.9% [95% CI 14.2% to 22%]. All‐cause mortality was 3.7% [95% CI 2.1% to 5.6%], which should be viewed in the context of an STS PROM of 5.0%.ConclusionsThis analysis suggests that TAVR for BcAV is not associated with excess mortality. The incidence of paravalvular leaks and pacemaker implant is increased compared to tricuspid aortic valve cohorts undergoing TAVR, and operators should weigh these potential complications against the clinical benefit provided by TAVR for BcAV patients at high risk for surgical valve replacement.

Structural heart disease is a rapidly evolving field, and approaches to procedural training are not standardized. We describe a novel modular approach to procedural training that considers each procedure as a series of building blocks that may be taught and assessed separately. Ten key structural heart disease building blocks can be identified, which, when combined with the cognitive skills of structural intervention and device-specific training, allow appropriate planning and implementation of structural procedures. Structural procedures require careful navigation of the aorta, left atrium, and right heart, including detailed understanding of relational anatomy. Component blocks include large bore vascular access, navigation within the left atrium, occlusion, snaring, and 3-dimensional relational anatomy. These building blocks also provide the foundation for new procedures through innovative use of the skill sets and devices to approach new clinical problems. The addition of device-specific training may be provided via proctoring and industry support. Using this approach, competency in less common procedures may be achieved and maintained. We discuss each building block in detail, approaches specific to the structural heart disease patient, the need for cross-discipline training, and empirical recommendations for training using this approach. We postulate that this new paradigm may be the preferred approach for training and assessment of structural heart disease interventional skills.

AbstractBackgroundRacial disparities in cardiovascular care have been extensively investigated. The introduction of transcatheter aortic valve replacement (TAVR) revolutionized the treatment of aortic stenosis (AS) in the last decade. Whether a racial disparity in the utilization and outcome of TAVR exists is unknown.MethodsWe utilized the nationwide inpatient sample (NIS) to compare utilization rates, and in‐hospital outcomes of Caucasians and African American (AA) patients who underwent TAVR between August 2011 and December 2014.ResultsA total of 7,176 patients (6870 Caucasians, 95.7%) and (306 AAs, 4.3%) were included in this analysis. Among patients who underwent aortic valve replacement between 2011 and 2014, the rates of TAVR utilization increased from 0.32% to 7.6% in AAs and from 0.4% to 8.8% in Caucasians. In propensity‐matched cohorts of patients (n = 300 Caucasians and n = 300 AAs), in‐hospital mortality was similar (3.7% and 3.3%, respectively, P = 0.99). Also, rates of key complications including stroke, permanent pacemaker implantation (PPMI), vascular complications, acute kidney injury, new dialysis, blood transfusion, and tamponade were similar in both races. There was also no significant difference between Caucasians and AAs with regards to length of stay, cost of hospitalization, and intermediate care facility utilization.ConclusionsThere was no significant difference in the utilization rates, in‐hospital outcomes, and cost of TAVR between Caucasians and AA patients in contemporary US practice. Further comparative studies of surgical and TAVR in AAs and other racial minorities are warranted.

Background Studies assessing the differential impact of sex on outcomes of aortic valve replacement ( AVR ) yielded conflicting results. We sought to investigate sex‐related differences in AVR utilization, patient risk profile, and in‐hospital outcomes using the Nationwide Inpatient Sample. Methods and Results In total, 166 809 patients (63% male and 37% female) who underwent AVR between 2003 and 2014 were identified, and 48.5% had a concomitant cardiac surgery procedure. Compared with men, women were older and had more nonatherosclerotic comorbid conditions including hypertension, diabetes mellitus, obstructive pulmonary disease, atrial fibrillation/flutter, and anemia but fewer incidences of coronary and peripheral arterial disease and prior sternotomies. In‐hospital mortality was significantly higher in women (5.6% versus 4%, P <0.001). Propensity matching was performed to assess the impact of sex on the outcomes of isolated AVR and yielded 28 237 matched pairs of male and female participants. In the propensity‐matched groups, in‐hospital mortality was higher in women (3.3% versus 2.9%, P <0.001). Along with vascular complications and blood transfusion (6% versus 5.6%, P =0.027 and 40.4% versus 33.9%, P <0.001, respectively). Rates of stroke, permanent pacemaker implantation, and acute kidney injury requiring dialysis were similar (2.4% versus 2.4%, P =0.99; 6% versus 6.3%, P =0.15; and 1.4% versus 1.3%, P =0.14, respectively). Length of stay median and interquartile range were both similar between groups (7±6 days). Rates of nonhome discharge were higher among women (27.9% versus 19.6%, P <0.001). Conclusions Women have worse in‐hospital mortality following AVR compared with men. Coupled with the accumulating evidence suggesting higher magnitude of benefit of transcatheter AVR over AVR in women, women should perhaps be offered transcatheter AVR over AVR at a lower threshold than men.

VA Cooperative Studies Program #571 (DIVA) was designed to evaluate the efficacy of drug‐eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure when compared with bare‐metal stents (BMS) in participants undergoing stenting of de novo SVG lesions. Participants undergoing clinically indicated stenting of de novo SVG lesions were randomized in a 1:1 ratio to DES or BMS. Randomization was stratified by presence/absence of diabetes mellitus and the number of target SVG lesions (1 vs ≥2) within each participating site. At sites that did not routinely administer 12‐months of dual antiplatelet therapy after SVG stenting participants without acute coronary syndromes received 1 month of open‐label clopidogrel, followed by 11 months of clopidogrel for those assigned to DES and 11 months of placebo for those assigned to BMS. The primary endpoint was the 12‐month incidence of target‐vessel failure (defined as the composite of cardiac death, target‐vessel myocardial infarction, or target‐vessel revascularization). Secondary endpoints included the incidence of other clinical endpoints and the incremental cost‐effectiveness of DES relative to BMS. Due to lower‐than‐anticipated target‐vessel failure rates, target enrollment was increased from 519 to 762. The study had randomized 599 participants when recruitment ended in December 2015. The DIVA trial will provide clarity on the appropriate stent type for de novo SVG lesions.

Background— The introduction of transcatheter aortic valve replacement (TAVR) led to renewed interest in balloon aortic valvuloplasty (BAV). We sought to assess contemporary trends in BAV utilization and their outcomes. Methods and Results— The Nationwide Inpatient Sample was used to identify patients who underwent BAV between 2004 and 2013. In-hospital morbidity and mortality, and predictors of death after BAV were assessed. Outcomes of propensity-matched groups of patients undergoing elective BAV or TAVR were evaluated. BAV utilization increased from 707 cases in 2004 to 3715 cases in 2013 (national estimates). Procedural and in-hospital mortality were 1.4% and 8.5%, respectively. Vascular complications occurred in 7.0% of cases, blood transfusion in 17.5%, clinical stroke in 1.8%, and pacemaker implantation in 3.0%. The strongest predictors of in-hospital death were cardiogenic shock (odds ratio, 6.01; 95% confidence interval, 4.19–8.61; P <0.001), need for left ventricular assist device (odds ratio, 3.48; 95% confidence interval, 2.25–5.36; P <0.001), coagulopathy (odds ratio, 2.19; 95% confidence interval, 1.51–3.18; P <0.001), and low institutional volume of BAV (odds ratio, 1.58; 95% confidence interval, 1.06–2.37; P =0.03). In propensity-matched patients undergoing elective BAV or TAVR, rates of in-hospital mortality (2.9% versus 3.5%; P =0.60), clinical stroke (1.6% versus 3.1%; P =0.10), and vascular complications (8.2% versus 10.9%; P =0.14) were similar. However, BAV was associated with lower rates of pacemaker implantation (2.9% versus 8.0%; P <0.001) and blood transfusion (12.8% versus 22.9%; P <0.001). Conclusions— In a contemporary national registry, BAV is associated with significant morbidity and mortality that are similar to TAVR. With the substantial increase in BAV utilization and the continuous improvement in TAVR outcomes, these data have important implications to aid clinicians in the selection of appropriate BAV candidates.

Leaflet immobility and valve thrombosis have been reported with both transcatheter and surgical aortic valve bioprostheses. The relationships between these abnormalities and their incidence, time course, clinical significance, predisposing factors, optimal imaging modality, and current therapeutic options remain uncertain but are rapidly evolving. Four-dimensional computerized tomographic imaging has been determined to have the highest sensitivity in studies evaluating leaflet immobility and valve thrombosis. Echocardiography is also used during surveillance, but it appears to be less sensitive. The definitive diagnosis of valve thrombosis is based on a combination of diagnostic 4-dimensional computerized tomographic imaging findings, resolution of imaging abnormalities, and elevated transcatheter gradients with anticoagulation or surgical or pathological confirmation. Uncertainty about the incidence and clinical significance of the findings is the basis of 2 US Food and Drug Administration–approved studies comparing transcatheter and surgical aortic valve replacement with a subset undergoing surveillance 4-dimensional computerized tomographic imaging. Given the expansion of transcatheter aortic valve procedures, including potentially lower-risk patients, the resolution of these uncertainties is critical.