Predictors of 1-Year Mortality in Men Versus Women Undergoing Transfemoral Transcatheter Aortic Valve Implantation.

Although gender-related disparities in intermediate-term outcomes have been reported after transcatheter aortic valve implantation (TAVI), disparate predictors of mortality in men and women who underwent TAVI have not been well studied. This prospective institutional registry study included 297 consecutive patients (153 men, 144 women) who underwent transfemoral TAVI from December 2015 to June 2018 at an academic tertiary medical center. Baseline and clinical characteristics, procedural data, and clinical outcomes at 1 year were recorded. Mortality rates at 1 year were 11.1% and 20.3% in women and men, respectively (p = 0.033). Risk-adjusted mortality was significantly higher in men who underwent TAVI than in women (odds ratio [OR] 2.45, 95% confidence interval [CI] 1.24 to 4.87, p = 0.010). Gender-specific risk-adjusted predictors of 1-year mortality post-TAVI included the presence of atrial fibrillation (OR 4.20, 95% CI 1.31 to 13.46, p = 0.016) and peripheral artery disease (OR 4.64, 95% CI 1.04 to 20.71, p = 0.044) in women and presence of chronic obstructive pulmonary disease (OR 3.14, 95% CI 1.13 to 8.72, p = 0.029), higher serum creatinine (OR 1.57, 95% CI 1.15 to 2.15, p = 0.004), and lower body mass index (OR 0.88, 95% CI 0.80 to 0.97, p = 0.008) in men. In this prospective institutional registry of adults who underwent TAVI, risk-adjusted 1-year mortality is significantly lower in women, and disparate predictors of risk-adjusted 1-year mortality exist in men and women.

Distressed Communities Index in Patients Undergoing Transcatheter Aortic Valve Implantation in an Affluent County in New York.

BACKGROUND: The clinical impact of the distressed communities index (DCI), a composite measure of economic well-being based on the U.S. zip code, is becoming increasingly recognized. Ranging from 0 (prosperous) to 100 (distressed), DCI's association with cardiovascular outcomes remains unknown. We aimed to study the association of the DCI with presentation and outcomes in adults with severe symptomatic aortic stenosis (AS) undergoing transcatheter aortic valve intervention (TAVR) in an affluent county in New York. METHODS: The study population included 286 patients with severe symptomatic AS or degeneration of a bioprosthetic valve who underwent TAVR with a newer generation transcatheter heart valve (THV) from December 2015 to June 2018 at an academic tertiary medical center. DCI for each patient was derived from their primary residence zip code. Patients were classified into DCI deciles and then categorized into 4 groups. The primary and secondary outcomes of interest were 30-day, 1-year, and 3-year mortality, respectively. RESULTS: Among 286 patients studied, 26%, 28%, 28%, and 18% were categorized into DCI groups 1-4, respectively (DCI <10: n = 73; DCI 10-20: n = 81; DCI 20-30: n = 80; DCI >30: n = 52). Patients in group 4 were younger with worse kidney function compared to patients in groups 1 and 2. They also had smaller aortic annuli and were more likely to receive a smaller THV. No significant difference in hospital length of stay or distribution of in-hospital, 30-day, 1-year, and 3-year mortality was demonstrated. CONCLUSIONS: While the DCI was associated with differences in the clinical and anatomic profile, it was not associated with differences in clinical outcomes in this prospective observational study of adults undergoing TAVR suggesting that access to care is the likely discriminator.

Impact of Severity of Chronic Kidney Disease on Management and Outcomes Following Transcatheter Aortic Valve Replacement With Newer-Generation Transcatheter Valves.

BACKGROUND: The association between chronic kidney disease (CKD) and outcomes following transcatheter aortic valve replacement (TAVR) in the setting of newer-generation transcatheter heart valves (THVs) is not well known. Accordingly, we sought to assess the impact of CKD severity on outcomes in adults undergoing TAVR with newer-generation THVs. METHODS: The study population included 298 consecutive patients who underwent TAVR with a newer-generation THV (Sapien 3 [Edwards Lifesciences] or CoreValve Evolut R or Evolut Pro [Medtronic]) from December 2015 to June 2018 at an academic tertiary medical center. Patients were classified into three groups: group I, defined as creatinine clearance (CrCl) ≥60 mL/ min (n = 133); group II, defined as CrCl ≥30 mL/min and <60 mL/min (n = 128); and group III, defined as CrCl <30 mL/min (n = 37). RESULTS: Median length of stay was longer in groups II and III (2.0 days in group I vs 3.0 days in group II vs 4.0 days in group III; P<.01). While rates of 30-day readmission were significantly higher in groups II and III compared with group I (14.5% in group I vs 26.6% in group II vs 37.1% in group III; P<.01), rates of in-hospital and 30-day mortality and disabling stroke were similar. In multivariable analysis, CKD was independently associated with higher 30-day readmission rates (group II: odds ratio, 2.10; 95% confidence interval 1.02-4.32; group III: odds ratio, 3.52; 95% confidence interval, 1.40-8.87; group I: referent). CONCLUSIONS: In this prospective study of adults undergoing TAVR with newer-generation THVs, moderate and severe CKD was associated with a nearly 2-fold and 3-fold higher risk of 30-day readmission, respectively.

Gender Disparities in Management and Outcomes Following Transcatheter Aortic Valve Implantation With Newer Generation Transcatheter Valves.

The impact of gender on management and early outcomes after transcatheter aortic valve implantation (TAVI) in the setting of newer generation transcatheter heart valves (THVs) is not well known. We evaluated gender-specific differences on clinical management and in-hospital outcomes in adults who underwent TAVI with newer generation THVs. The study population included 298 consecutive patients who underwent TAVI and received a newer generation THV (Sapien 3 [Edwards Lifesciences, Irvine, California] or Corevalve Evolut R or Evolut Pro [Medtronic, Minneapolis, Minnesota]) from December 2015 to June 2018 at an academic tertiary medical center. Of the 298 patients, 154 (52%) were men and 144 (48%) were women. Compared with men, women were older, had lower serum creatinine, higher left ventricular ejection fraction, and lower rates of multiple co-morbidities, including previous coronary artery bypass graft surgery, previous myocardial infarction, and atrial fibrillation. Women were noted to have smaller aortic annular area and perimeter and underwent implantation of smaller THVs than men. At the time of discharge, women were more frequently prescribed a P2Y12 inhibitor (primarily clopidogrel) and less frequently prescribed oral anticoagulation (namely warfarin). Hospital length of stay and in-hospital rates of mortality, disabling stroke, and pacemaker were similar in men and women. In conclusion, in this observational prospective study of adults who underwent TAVI with newer generation THVs, while gender-related disparities in clinical presentation and procedural management were observed, no significant difference in clinical outcomes were noted in men and women. Further studies examining gender-related differences in procedural and postprocedural care after TAVI in the contemporary era are warranted to better understand and optimize clinical outcomes in both men and women.

Physician report cards and rankings yield long-lasting hand hygiene compliance exceeding 90%.

INTRODUCTION: Hand hygiene is an effective, low-cost intervention that prevents the spread of multidrug-resistant bacteria. Despite mandatory education and reminders, compliance by physicians in our hospital remained stubbornly low. Our objective was to study whether surveillance by our unit coordinator (secretary) paired with regular feedback to chiefs of service would increase physician hand hygiene compliance in the ICU. METHOD: The ICU unit coordinator was trained to observe and measure hand hygiene compliance. Data were collected on hand hygiene compliance at room entry and exit for 9 months. Percentage compliance for each medical and surgical subspecialty was reported to chiefs of service at the end of each month. Comparative rankings by service were widely distributed throughout the physician organization and the medical center. RESULTS: The hand hygiene compliance rate among physicians increased from 65.1% to 91.6% during the study period (p < 0.0001). More importantly in the succeeding 24 months after study completion, physician hand hygiene compliance remained >90% in every month. CONCLUSIONS: Physician hand hygiene compliance increased as a consequence of the surveillance conducted by a full-time ICU team member, leading to a highly significant increase in the number of observations. In turn, this allowed for specific comparative monthly feedback to individual chiefs of service. Over the next 2 years after the study ended, these gains were sustained, suggesting an enduring culture change in physician behavior.

A framework for real-time glycosylation monitoring (RT-GM) in mammalian cell culture.

Glycosylation is a critical characteristic of biotherapeutics because of its central role in in vivo efficacy. Multiple factors including medium composition and process conditions impact protein glycosylation and characterizing cellular response to these changes is essential to understand the underlying relationships. Current practice typically involves glycosylation characterization at the end of a fed-batch culture, which in addition to being an aggregate of the process, reflects a bias towards the end of the culture where a majority of the product is made. In an attempt to rigorously characterize the entire time-course of a fed-batch culture, a real-time glycosylation monitoring (RT-GM) framework was developed. It involves using the micro sequential injection (µSI) system as a sample preparation platform coupled with an ultra-performance liquid chromatography (UPLC) system for real-time monitoring of the antibody glycan profile. Automated sampling and sample preparations were performed using the µSI system and this framework was used to study manganese (Mn)-induced glycosylation changes over the course of a fed-batch culture. As expected, Mn-supplemented cultures exhibited higher galactosylation levels compared to control while the fucosylation and mannosylation were consistent for both supplemented and control cultures. Overall, the approach presented in the study allows real time monitoring of glycosylation changes and this information can be rapidly translated into process control and/or process optimization decisions to accelerate process development.

Impaired hyperemic response is predictive of early access failure.

The aim of this study was to demonstrate that hyperemic response is a predictor of access failure. We conducted a review of a prospective database of dialysis access patients with preoperative hyperemia studies from June 1998 to August 2002. These consisted of bilateral brachial artery pressures followed by flow velocity measurements of the brachial artery and radial artery at rest and after 3 min of arm ischemia. Measurements were taken by using a cuff placed above the antecubital fossa and inflated to 20 mmHg above systolic pressure. There were no differences recorded in brachial artery pressures for the bilateral studies. Hyperemic response was entered into a stepwise Cox regression to determine its effect on access failure. Access failure was defined as failure to mature or thrombosis. Accesses were placed according to Dialysis Outcome Quality Intiatives (DOQI) guidelines. Kaplan-Meier survival analysis was performed. Log-rank testing was used to compare patency results. Censored end points were death, renal transplant, and access survival to the end of the study period. Fistulas that failed to mature were considered failures at 3 months. Arteries with a <5 cm/sec increase in peak systolic velocity were defined as nonresponders. The 59 arteries used for dialysis access were divided into two groups on the basis of their hyperemic response in cm/sec. The nonresponders were compared with the remainder of accesses performed. Accesses based on arteries with absent or minimal hyperemic response had significantly lower (p < 0.0005) secondary patencies by Kaplan-Meier analysis. Upon further stratification into radial and brachial arteries, the significant difference in secondary patency remained for radial artery--based accesses (p = 0.024) and approached statistical significance for brachial artery--based accesses (p = 0.057). A significant difference was not seen in primary patencies, indicating that accesses based on arteries with an acceptable hyperemic response are more likely to be salvaged by revisions. A nonresponsive radial artery was not a significant predictor of a nonresponsive brachial artery in the same extremity by binary logistic regression (p = 0.111), and a nonresponsive artery was not a significant predictor of nonresponsiveness in the corresponding artery in the contralateral extremity (p = 0.137). Cox regression analysis revealed that the hyperemic response is a significant predictor of failure to mature or thrombosis. Hyperemic testing is a useful means of evaluating adequate arterial inflow for dialysis access. Reduced or absent hyperemic response is an independent predictor of access failure.