Faculty Bibliography

OBJECTIVES: This study sought to examine long-term outcomes with transcatheter aortic valve replacement (TAVR) in women versus men. BACKGROUND: TAVR is commonly performed in women. Previous studies have shown conflicting results with respect to sex differences in outcomes with TAVR. In addition, short-term outcomes have primarily been reported. METHODS: Electronic search was performed until March 2017 for studies reporting outcomes with TAVR in women versus men. Random effects DerSimonian-Laird risk ratios were calculated. Outcomes included all-cause mortality and major cardiovascular events at short- (30 days) and long-term (>1 year) follow-up. RESULTS: Seventeen studies (8 TAVR registries; 47,188 patients; 49.4% women) were analyzed. Women were older but exhibited fewer comorbidities. At 30 days, women had more bleeding (p < 0.001), vascular complications (p < 0.001), and stroke/transient ischemic attack (p = 0.02), without difference in all-cause (p = 0.19) or cardiovascular mortality (p = 0.91) compared with men. However, female sex was associated with lower all-cause mortality at 1 year (risk ratio: 0.85; 95% confidence interval: 0.79 to 0.91; p < 0.001), and longest available follow-up (mean 3.28 +/- 1.04 years; risk ratio: 0.86; 95% confidence interval: 0.81 to 0.92; p < 0.001), potentially caused by less moderate/severe aortic insufficiency (p = 0.001), and lower cardiovascular mortality (p = 0.009). The female survival advantage remained consistent across multiple secondary analyses. The risk of stroke, moderate/severe aortic insufficiency, and all-cause mortality seemed to vary based on the type of valve used; however, without significant subgroup interactions. CONCLUSIONS: Despite a higher upfront risk of complications, women derive a better long-term survival after TAVR compared with men.

BACKGROUND: Most drug-eluting stent (DES) trials have excluded patients with chronic kidney disease (CKD). The efficacy of DES implantation in patients with CKD is therefore not known. OBJECTIVES: To evaluate the outcomes with DES vs bare-metal stent (BMS) implantation in patients with CKD. METHODS AND RESULTS: MEDLINE, EMBASE, and CENTRAL were searched for studies including at least 100 patients with CKD (estimated glomerular filtration rate .05) except all-cause mortality, where there was no difference between DES vs BMS in RCTs (Pinteraction=.04). The effects were greater with 2nd-generation DES vs BMS (for example, ST: RR, 0.38; 95% CI, 0.20-0.72). CONCLUSIONS: In patients with CKD, the available evidence, largely from observational studies, suggests significantly fewer events with DES vs BMS with even a lower ST rate with 2nd-generation DES. These findings should be tested in large, randomized trials.

BACKGROUND: Transcatheter 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 RESULTS: We 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. CONCLUSION: Our 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.

OBJECTIVES: To compare subcutaneous "Z"-stitch versus manual compression in attaining hemostasis after large bore femoral venous access, and to assess its impact on venous patency. BACKGROUND: Structural interventions increasingly require large caliber venous access, for which convenient, safe, and effective method of postprocedural hemostasis is needed. "Z"-stitch has been introduced for this purpose in some centers but systematic data on its performance is limited. METHODS: This single center study randomized consecutive patients with femoral venous access sites requiring >/=10F sheaths to the "Z"-stitch or manual compression for hemostasis in a 2:1 fashion. There were three co-primary endpoints: time to hemostasis, time to ambulation, and a composite safety endpoint comprising vascular access site complications. Groin Doppler-Duplex was performed with the stitch in place and after its removal. RESULTS: 86 consecutive patients with 90 access sites were randomized. Mean age was 61.7 +/- 19.1 years, 33.3% were men. Median sheath size was 14 F (range 10-22 F). Patients randomized to "Z"-stitch achieved hemostasis quicker [<1 min vs. 12.0 (IQR 10.0-15.0) min, P < 0.001] and ambulated sooner [7.0 (IQR 4.0-12.0) vs. 16.0 (IQR 11.8-20.3) hr post procedure, P < 0.001] when compared with manual compression alone. The "Z"-stitch reduced rates of access site complications (OR = 0.27, 95%CI 0.09-0.76, P = 0.01). All imaged veins were patent before and after stitch removal. CONCLUSIONS: The "Z"-stitch is a safe and effective method of achieving hemostasis after large bore femoral venous sheath removal and results in faster hemostasis, early patient ambulation and less access site complications, without compromising vein patency when compared with manual compression alone. (c) 2017 Wiley Periodicals, Inc.

Background: We sought to examine long-term outcomes in patients admitted for a myocardial infarction (MI) based on whether they experienced community acquired acute kidney injury (CAAKI), hospital acquired acute kidney injury (HAAKI), or no acute kidney injury (no AKI).
Method(s): Methods: Retrospective parallel cohort analysis of Veterans admitted for acute MI between 2005 and 2008. Data was obtained from the corporate data warehouse (CDW) using the VA Informatics and Computing Infrastructure (VINCI) computing environment. AKI was determined by assessing for changes in serum creatinine according to the KDIGO AKI classification system. Outcomes were death, hospitalization for cardiovascular (CV) events (MI, congestive heart failure, or stroke).
Result(s): Results: 11,580 patients with an MI were identified. Of these patients 15.1% had CAAKI, 14.5% had HAAKI and 70.4% had no AKI. Patients who developed AKI (CAAKI or HAAKI) were older, and had greater number of comorbidities as well as severity of initial admission (ICU stay, ventilation requirement or dialysis requirement) than no AKI. Patients with CAAKI were less likely to get cardiac catheterization during admission than those with HAAKI or no AKI (44.7%, 57.9%, 67.3%, respectively, p<0.001). Mortality was higher in both AKI groups as compared to the no AKI group at 5 year follow-up (adjusted HR and 95%CI: CAAKI 1.96, 1.83-2.09; HAAKI 1.60, 1.50-1.72). Patients with AKI (CA or HA) were more likely to have a repeat CV hospitalization than patients with no AKI (CAAKI adjusted HR 1.14 p=0.004; HAAKI adjusted HR 1.11, p=0.02; no difference between AKI groups).
Conclusion(s):
Conclusion(s): In patients admitted with an acute MI, the presence of CAAKI was associated with long term outcomes as poor as HAAKI. Further research is needed to understand these associations

Background/UNASSIGNED:Venous thromboembolism (VTE) is a common vascular complication of non-cardiac surgery. Methods/UNASSIGNED:We evaluated national trends in perioperative in-hospital VTE incidence, management, and outcomes using a large database of hospital admissions from the United States. Patients aged ≥ 45 years undergoing major non-cardiac surgery from 2005 to 2013 were identified from the National Inpatient Sample. In-hospital perioperative VTE was defined as lower extremity deep vein thrombosis (DVT) or pulmonary embolism (PE), and the incidence was evaluated over time. Multivariable regression models with demographics and comorbidities as covariates were generated to estimate adjusted odds ratios (aOR). Results/UNASSIGNED:Major non-cardiac surgery was performed in 9,431,442 hospitalizations that met inclusion criteria, and perioperative VTE occurred in 99,776 patients (1,057 per 100,000), corresponding to an annual incidence of ≈53,000 after applying sample weights. Over time, perioperative VTE per 100,000 surgeries increased by 135 (95% CI 107 - 163), from 925 in 2005 to 1,060 in 2013 (p for trend <0.001; aOR [for 2013 versus 2005] 1.22, 95% CI 1.19 - 1.26), due to increases in non-fatal VTE rates (from 840 [per 100,000 surgeries] in 2005 to 987 in 2013; p for trend <0.001). Perioperative VTE occurred most frequently in patients undergoing thoracic (2.0%) and vascular surgery (1.8%). Mortality was higher in patients with VTE than those without VTE (aOR 3.12, 95% CI 3.05 - 3.20). Conclusions/UNASSIGNED:Perioperative VTE occurs in approximately 1% of patients ≥45 years undergoing major non-cardiac surgery, with increasing incidence of non-fatal VTE over time.

BACKGROUND:Gout, hyperuricemia, and cardiovascular disease (CVD) are prevalent conditions in the United States, and while they share common risk factors such as obesity, hypertension, hypercholesterolemia, and type 2 diabetes mellitus, relatively little is known about what patient and disease characteristics may link CVD with hyperuricemia and gout and how the presence of both diseases affects management decisions differently than for patients with gout alone. OBJECTIVE:To identify differences in patient characteristics, patterns of urate-lowering therapy (ULT) use, and gout control in gout patients with and without cardiovascular comorbidity. METHODS:Data were assessed from a survey of U.S. physicians who performed in-depth patient chart audits of their last 5 consecutive adult patients with confirmed gout as determined by the medical record and clinical notes. Comorbidities, gout symptoms, length of current treatment, sociodemographic factors, and physician type were identified from the chart review. Descriptive statistics and logistic regression described differences among patients with and without comorbid CVD and assessed ULT use and gout control. RESULTS:Of the 1,159 patient charts that were reviewed, 738 patients had CVD and gout, and 421 had gout alone. Patients with CVD had longer duration of gout (mean [SD] = 52 [68.2] vs. 34 [47.2] months; P < 0.001) and were more likely to have clinician-reported tophi (28% vs. 15%; P < 0.001), organ/joint damage (19% vs. 9%; P < 0.001), and more flares (2.1% vs. 1.8%; P = 0.017) in the previous 12 months. Time from gout diagnosis to start of ULT was delayed for those with CVD (mean [SD] = 24.3 [56.6] vs. 15.5 [33.2] months; P = 0.023), but these patients were more likely to be receiving ULT (83% vs. 59%; P < 0.001). Gout patients with CVD were more likely to have a variety of additional comorbidities than those without CVD, such as obesity (28% vs. 18%; P < 0.001), diabetes (26% vs. 12%; P < 0.001), osteoarthritis (25% vs. 11%; P < 0.001), chronic kidney disease (17% vs. 5%; P < 0.001), and prostate disease (males, n = 933; 10% vs. 2%; P < 0.001). Gout patients with CVD were more likely to have an emergency department visit (12% vs. 7%; P = 0.003) for gout in the previous 12 months. In patients with CVD, ULT use was associated with better gout control. CONCLUSIONS:Gout patients with CVD were more likely to have additional comorbidities, more gout-related symptoms, and a delay in initiating treatment, which may be associated with the greater severity of disease in these patients. These data suggest that gout patients with CVD may constitute a less healthy group in need of earlier, more aggressive therapy. DISCLOSURES/UNASSIGNED:This study was supported by AstraZeneca. Pillinger reports consultancies at AstraZeneca, SOBI, Crealta/Horizon; investigator-initiated grants from Takeda (closed 2016); and was an investigator on industry-sponsored clinical trials for Takeda. Klein is employed by AstraZeneca. At the time of this study, Baumgartner was employed by Ardea Biosciences, a wholly owned subsidiary of AstraZeneca and owns stock in AstraZeneca. Baumgartner and Morlock are consultants to Ardea Biosciences. Morlock reports consulting fees from Genentech, Ironwood Pharmaceuticals, Astellas, and Abbot Medical Optics outside of this study. Bangalore reports consultancies at Pfizer, Merck, Abbott Vascular, Medicines Company, AstraZeneca, and the National Heart, Lung, and Blood Institute. The authors did not receive any honoraria for this publication. Study concept and design were primarily contributed by Morlock, along with the other authors. Morlock collected the data, and data interpretation was performed by all the authors. All authors equally contributed to preparation and revision of the manuscript. Preliminary results from this study were presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2016; San Francisco, California; April 19-22, 2016.