High prevalence of cardiometabolic risk factors amongst young adults in the United Arab Emirates: the UAE Healthy Future Study.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death in the world. In the United Arab Emirates (UAE), it accounts for 40% of mortality. CVD is caused by multiple cardiometabolic risk factors (CRFs) including obesity, dysglycemia, dyslipidemia, hypertension and central obesity. However, there are limited studies focusing on the CVD risk burden among young Emirati adults. This study investigates the burden of CRFs in a sample of young Emiratis, and estimates the distribution in relation to sociodemographic and behavioral determinants. METHODS: Data was used from the baseline data of the UAE Healthy Future Study volunteers. The study participants were aged 18 to 40 years. The study analysis was based on self-reported questionnaires, anthropometric and blood pressure measurements, as well as blood analysis. RESULTS: A total of 5167 participants were included in the analysis; 62% were males and the mean age of the sample was 25.7 years. The age-adjusted prevalence was 26.5% for obesity, 11.7% for dysglycemia, 62.7% for dyslipidemia, 22.4% for hypertension and 22.5% for central obesity. The CRFs were distributed differently when compared within social and behavioral groups. For example, obesity, dyslipidemia and central obesity in men were found higher among smokers than non-smokers (p < 0.05). And among women with lower education, all CRFs were reported significantly higher than those with higher education, except for hypertension. Most CRFs were significantly higher among men and women with positive family history of common non-communicable diseases. CONCLUSIONS: CRFs are highly prevalent in the young Emirati adults of the UAE Healthy Future Study. The difference in CRF distribution among social and behavioral groups can be taken into account to target group-specific prevention measures.

Temporal Trends in the Utilization and Outcomes of Balloon Aortic Valvuloplasty in the Pre-Transcatheter Aortic Valve Implantation (TAVI) and TAVI Eras.

We used a nationwide cohort to (1) compare characteristics and outcomes of patients who underwent balloon aortic valvuloplasty (BAV) in pre-transcatheter aortic valve transplantation (TAVI) and TAVI eras, (2) examine trends in utilization and outcomes of BAV from 2005 to 2017, (3) assess the association of BAV procedural volume with hospital-based TAVI volume, and (4) understand trends and outcomes of BAV in TAVI and non-TAVI centers in the TAVI era. Pre-TAVI era included hospitalizations from 2005 to 2011, and TAVI era included hospitalizations from 2012 to 2017. In the TAVI era, hospitals were classified into quartiles based on the number of TAVI procedures performed. Trends in volume of BAV procedures from 2012 to 2017 were assessed in non-TAVI and TAVI centers (based on TAVI volume). Between 2005 and 2017, a total of 6,962 hospitalizations for BAV were identified. There were no significant differences in in-hospital mortality or stroke between pre-TAVI and TAVI eras (mortality: pre-TAVI, 8.5% vs TAVI era, 9.3%, p = 0.354; stroke: pre-TAVI, 1.9% vs TAVI era, 1.3%, p = 0.083). However, acute kidney injury was more prevalent in the TAVI era and blood transfusion in the pre-TAVI era. Importantly, patients who underwent BAV in the TAVI era were more likely to have a greater number of co-morbidities and to undergo nonelective procedures. From 2005 to 2017, there was 10-fold increase in utilization of BAV. In the TAVI era, the maximum increase in number of BAV procedures was seen in hospitals with highest TAVI volume. In conclusion, although BAV procedural volume increased approximately 10-fold between 2005 and 2017, with concomitant expansion of TAVI, rates of mortality and stroke have remained stable. Despite this, the rate of BAV utilization continues to increase, thereby indicating a significant opportunity to improve outcomes in this patient population.

Plaque microstructures during metformin therapy in type 2 diabetic subjects with coronary artery disease: optical coherence tomography analysis.

Background: While metformin is recommended as a first-line cardioprotective therapy for type 2 diabetic patients, whether it exerts direct effects on atherosclerotic plaque remains uncertain. The current study characterized coronary plaque microstructures in type 2 diabetic patients who received metformin. Methods: We retrospectively analyzed 409 non-culprit lipid plaques in 313 type 2 diabetic patients with coronary artery disease (CAD) by using frequency-domain optical coherence tomography (FD-OCT) imaging. FD-OCT derived plaque microstructures were compared in patients stratified according to metformin use. Results: A proportion of 38.6% of study subjects received metformin. Patients receiving metformin more likely exhibited a history of hypertension (79.3% vs. 67.1%, P=0.03) and metabolic syndrome (52.8% vs. 36.4%, P=0.01). On FD-OCT imaging, the prevalence of lipid plaque was lower in the metformin group (66.2% vs. 77.9%, P=0.03). Furthermore, the metformin group demonstrated plaques with a smaller lipid arc (median: 168.7° vs. 208.5°, P=0.008), shorter longitudinal length (media: 5.1 vs. 9.1 mm, P=0.04), and a lower frequency of cholesterol crystal (3.9% vs. 18.2%, P=0.01) and spotty calcification (3.9% vs. 34.8%, P=0.008). These differences remained significant after adjusting for clinical characteristics and glycemic control. However, in patients who received insulin, the favourable effect of metformin on lipid arc was not observed (insulin user: P=0.87; insulin non-user: P=0.009; P value for interaction between two groups, P=0.02). Conclusions: Metformin use was associated with a lower prevalence of vulnerable plaque features in type 2 diabetic patients with CAD, especially insulin non-user. These findings suggest the potential of metformin to exert direct plaque stabilization effects in type 2 diabetic subjects.

HbA1c, Coronary atheroma progression and cardiovascular outcomes.

BACKGROUND AND AIMS: We tested the hypothesis that on-treatment HbA1c levels independently associate with coronary atheroma progression and major adverse cardiovascular events (MACE: death, myocardial infarction, cerebrovascular accident, coronary revascularization, or hospitalization for unstable angina) rates. METHODS: We performed a post-hoc pooled analysis of data from seven prospective, randomized trials involving serial coronary intravascular ultrasonography (IVUS). The percent atheroma volume (PAV) was calculated as the proportion of the entire vessel wall occupied by atherosclerotic plaque. Using multivariable mixed modeling, we determined the association of on-treatment HbA1c with annualized change in PAV. Cox proportional hazard models were used to assess the association of HbA1c with incidence of MACE. RESULTS: Among 3,312 patients (mean age 58.6±9years, 28.4%women) average on-treatment HbA1c was 6.2±1.1%. Overall, there was no net significant annualized change in PAV (0.12±0.19%, p = 0.52). In a fully adjusted multivariable analysis (following adjustment of age, sex, body mass index, systolic blood pressure, smoking, low- and high-density lipoprotein cholesterol, triglyceride levels, peripheral vascular disease, trial, region, and baseline PAV), higher on-treatment HbA1c levels were independently associated with annualized changes in PAV [beta-estimate (95% confidence interval): 0.13(0.08, 0.19), p < 0.001]. On-treatment HbA1c levels were independently associated with MACE [hazard ratio (95% confidence interval): 1.13(1.04, 1.23), p = 0.005]. CONCLUSIONS: Independent of achieved cardiovascular risk factor control, greater HbA1c levels significantly associate with coronary atheroma progression rates and clinical outcomes. These results support the notion of a direct, specific effect of glycemic control upon coronary atheroma and atherosclerotic events, supporting the rationale of therapies designed to directly modulate it.

Incidence, treatment, and outcomes of acute myocardial infarction following transcatheter or surgical aortic valve replacement.

OBJECTIVES: This study aimed to evaluate the incidence, treatment, and outcomes of acute myocardial infarction (AMI) following transcatheter or surgical aortic valve replacement (TAVR or SAVR). BACKGROUND: Coronary artery disease is common in patients who undergo aortic valve replacement. However, little is known about differences in clinical features of post-TAVR or post-SAVR AMI. METHODS: We retrospectively identified post-TAVR or post-SAVR (including isolated and complex SAVR) patients admitted with AMI using the Nationwide Readmissions Database 2012-2017. Incidence, invasive strategy (coronary angiography or revascularization), and in-hospital outcomes were compared between post-TAVR and post-SAVR AMIs. RESULTS: The incidence of 180-day AMI was higher post-TAVR than post-SAVR (1.59% vs. 0.72%; p < 0.001). Post-TAVR AMI patients (n = 1315), compared with post-SAVR AMI patients (n = 1344), were older, had more comorbidities and more frequent non-ST-elevation AMI (NSTEMI: 86.6% vs. 78.0%; p < 0.001). After propensity-score matching, there was no significant difference in in-hospital mortality between post-TAVR and post-SAVR AMIs (14.7% vs. 16.1%; p = 0.531), but the mortality was high in both groups, particularly in ST-elevation AMI (STEMI: 38.8% vs. 29.2%; p = 0.153). Invasive strategy was used less frequently for post-TAVR AMI than post-SAVR AMI (25.6% vs. 38.3%; p < 0.001). Invasive strategy was associated with lower mortality in both post-TAVR (adjusted odds ratio = 0.40; 95% confidence interval = [0.24-0.66]) and post-SAVR groups (0.60 [0.41-0.88]). CONCLUSIONS: AMI, albeit uncommon, was more frequent post-TAVR than post-SAVR. Patients commonly presented with NSTEMI, but the mortality of STEMI was markedly high. Further studies are needed to understand why a substantial percentage of patients do not receive invasive coronary treatment, particularly after TAVR, despite seemingly better outcomes with invasive strategy.

Transcatheter Aortic Valve Replacement-Associated Infective Endocarditis: Comparison of Early, Intermediate, and Late-Onset Cases.

Background: Transcatheter aortic valve replacement-associated infective endocarditis (TAVR-IE) is a relatively rare complication of TAVR. Little is known about the characteristics of early, intermediate, and late-onset TAVR-IE. Methods: We studied the risk factors, microbiological patterns, and diagnostic and treatment strategies in patients with early (<60 days), intermediate (60-365 days), and late-onset (>1 year) TAVR-IE. Results: Ten out of 494 definite cases of prosthetic valve IE between 2007 and 2019 were confirmed to have TAVR-IE from the IE registry at our center. The mean age was 78.1 ± 13.7 years, with 50% being female. The mean Society of Thoracic Surgeons risk score was 7.8 ± 5.7. Most (60%) TAVR-IE cases had an intermediate onset, with Staphylococcus aureus being the most common organism (66.6%). 18-fluorodeoxyglucose positron emission tomography aided in diagnosis of TAVR-IE in 20% of cases. Mortality due to IE was observed in 40% of cases. Most of the patients underwent conservative management, and 37.5% survived over a mean follow-up of 709 ± 453 days. Two patients underwent surgery, of whom one died on day 30 postoperatively from sepsis. Mortality due to IE occurred in 25% of cases in the early and intermediate-onset groups, while there was 100% mortality in the late-onset group. Conclusions: In a single-center cohort, most TAVR-IE cases had an intermediate onset, with Staphylococcus aureus being the most common organism. Understanding timing of TAVR-IE may have important prognostic implications.

The interrelationship and accumulation of cardiometabolic risk factors amongst young adults in the United Arab Emirates: The UAE Healthy Future Study.

INTRODUCTION: Similar to other non-communicable diseases (NCDs), people who develop cardiovascular disease (CVD) typically have more than one risk factor. The clustering of cardiovascular risk factors begins in youth, early adulthood, and middle age. The presence of multiple risk factors simultaneously has been shown to increase the risk for atherosclerosis development in young and middle-aged adults and risk of CVD in middle age. OBJECTIVE: This study aimed to address the interrelationship of CVD risk factors and their accumulation in a large sample of young adults in the United Arab Emirates (UAE). METHODS: Baseline data was drawn from the UAE Healthy Future Study (UAEHFS), a volunteer-based multicenter study that recruits Emirati nationals. Data of participants aged 18 to 40 years was used for cross-sectional analysis. Demographic and health information was collected through self-reported questionnaires. Anthropometric data and blood pressure were measured, and blood samples were collected. RESULTS: A total of 5126 participants were included in the analysis. Comorbidity analyses showed that dyslipidemia and obesity co-existed with other cardiometabolic risk factors (CRFs) more than 70% and 50% of the time, respectively. Multivariate logistic regression analysis of the risk factors with age and gender showed that all risk factors were highly associated with each other. The strongest relationship was found with obesity; it was associated with four-fold increase in the odds of having central obesity [adjusted OR 4.70 (95% CI (4.04-5.46)], and almost three-fold increase odds of having abnormal glycemic status [AOR 2.98 (95% (CI 2.49-3.55))], hypertension (AOR 3.03 (95% CI (2.61-3.52))] and dyslipidemia [AOR 2.71 (95% CI (2.32-3.15)]. Forty percent of the population accumulated more than 2 risk factors, and the burden increased with age. CONCLUSION: In this young population, cardiometabolic risk factors are highly prevalent and are associated with each other, therefore creating a heavy burden of risk factors. This forecasts an increase in the burden of CVD in the UAE. The robust longitudinal design of the UAEHFS will enable researchers to understand how risk factors cluster before disease develops. This knowledge will offer a novel approach to design group-specific preventive measures for CVD development.

Systematic Approach to High Implantation of SAPIEN-3 Valve Achieves a Lower Rate of Conduction Abnormalities Including Pacemaker Implantation.

BACKGROUND: The conventional method of implanting balloon-expandable SAPIEN-3 (S3) valve results in a final 70:30 or 80:20 ratio of the valve in the aorta:left ventricular outflow tract with published rates of permanent pacemaker around 10%. We sought to evaluate whether higher implantation of S3 reduces conduction abnormalities including the need for permanent pacemaker. METHODS: We included consecutive patients who underwent transfemoral transcatheter aortic valve replacement using S3 between April 2015 and December 2018 and compared outcomes with typical valve deployment strategy to our more contemporary high deployment technique (HDT). We excluded patients with nontransfemoral access or valve-in-valve. RESULTS: Among 1028 patients, HDT was performed in 406 patients (39.5%). Mean implantation depth under the noncoronary cusp was significantly smaller with HDT compared with conventional technique (1.5±1.6 versus 3.2±1.9 mm; P<0.001). Successful implantation was achieved in 100% of the patients in both groups with no cases of conversion to open heart surgery, second valve implantation within the first transcatheter aortic valve replacement, or coronary occlusion during transcatheter aortic valve replacement. One patient (0.2%) had valve embolization with HDT (P=0.216). Thirty-day permanent pacemaker rates were lower with HDT (5.5% versus 13.1%; P<0.001), as were rates of complete heart block (3.5% versus 11.2%; P<0.001) and new-onset left bundle branch block (5.3% versus 12.2%; P<0.001). There were no differences in mild (16.5% versus 15.9%; P=0.804), or moderate-to-severe aortic regurgitation (1% versus 2.7%; P=0.081) at 1 year. HDT was associated with slightly higher 1-year mean gradients (13.1±6.2 versus 11.8±4.9 mm Hg; P=0.042) and peak gradients (25±11.9 versus 22.5±9 mm Hg; P=0.026). However, Doppler velocity index was similar (0.47±0.15 versus 0.48±0.13; P=0.772). CONCLUSIONS: Our novel technique for balloon-expandable S3 valve positioning consistently achieves higher implantation resulting in substantial reduction in conduction abnormalities and permanent pacemaker requirement after transcatheter aortic valve replacement without compromising procedural safety or valve hemodynamics. Operators should consider this as an important technique to improve patient outcomes.

End-stage renal disease as an independent risk factor for in-hospital mortality after coronary drug-eluting stenting: Understanding and modeling the risk.

OBJECTIVES: We sought to compare in-hospital outcomes between patients with and without end-stage renal disease (ESRD) undergoing coronary drug-eluting stent (DES) placement and to model risk of in-hospital adverse postpercutaneous coronary intervention (PCI) events in ESRD patients. BACKGROUND: The effect of ESRD on the risk of in-hospital complications after DES PCI is relatively unclear, as is the ability to prospectively stratify risk in this population. METHODS: Consecutive patients undergoing first-time DES between April 1, 2003 and June 30, 2018 at a single tertiary care hospital were included in a prospective registry. Outcomes in those with ESRD were compared to those without ESRD. The primary endpoint was in-hospital all-cause mortality; secondary endpoints included in-hospital major adverse cardiac events (MACE)-defined as cardiac death, myocardial infarction, or unplanned revascularization-and major bleeding. Multivariate logistic regression modeling was used to identify factors associated with each outcome and to generate risk scores. RESULTS: Among 18,134 patients in the study population, 382 (2.1%) had ESRD. ESRD was associated with increased risk of in-hospital mortality (7.1 vs. 2.9%, p < .001), in-hospital MACE (6.3 vs. 2.1%, p < .001), and major bleeding (12.0 vs. 2.6%, p < .001). After multivariable risk adjustment, ESRD was independently associated with in-hospital mortality (odds ratio: 1.83, 95% confidence interval: 1.04-3.23, p = .04) but not MACE or major bleeding. Among patients with ESRD, risks of MACE and major bleeding were successfully modeled (c-statistics = .72 and .85, respectively). CONCLUSIONS: ESRD is independently associated with increased risk of in-hospital mortality after coronary DES. Future studies are necessary to validate risk models derived to identify high-risk ESRD patients.

Residency training in the time of COVID-19: A framework for academic medical centers dealing with the pandemic.

BACKGROUND: As cases of COVID-19 climb worldwide, academic medical centers (AMCs) are scrambling to balance the increasing demand for medical services while maintaining safe learning environments. The scale and nature of the current pandemic, limitations on key resources, risks of transmission, and the impact on trainee wellbeing pose additional challenges to AMCs. We propose a framework for AMCs to utilize in facilitating health system, organization and program-level adjustments to meet the needs of medical trainees during the pandemic. APPROACH: In February 2020, we developed a three-level approach to the pandemic response of training programs at our AMC. The first level involved AMC alignment and engagement with regulatory stakeholders. The second level utilized the graduate medical education committee and leveraged organizational functions such as human resources, finance, and clinical departments. The third level of intervention focused on common approaches used by programs to ensure continuity of learning in the context of dynamic changes in workflows and service operations. EVALUATION: Outcomes at each level are reported. These include the co-development of a national framework on medical trainee responses to COVID-19, the composition of an operational guidance document, organizational protocols to accommodate novel challenges posed by the pandemic, and multiple program-level interventions. REFLECTION: This methodical approach, employed during a global crisis, was critical in facilitating interventions required to fulfill the mission of AMCs. Future steps include assessing the impact of these changes on trainee performance and the applicability of the approach in diverse settings.

Adverse clinical outcomes in patients undergoing both PCI and TAVR: Analysis from a pooled multi-center registry.

BACKGROUND: There is a paucity of data regarding the optimum timing of PCI in relation to TAVR. OBJECTIVE: We compared the major adverse cardiovascular and cerebrovascular events (MACCE) rates among patients who underwent percutaneous coronary intervention (PCI) before transcatheter aortic valve replacement (TAVR) with those who received PCI with/after TAVR. METHODS: In this multicenter study, we pooled all consecutive patients who underwent TAVR at three high volume centers. RESULTS: Among 3,982 patients who underwent TAVR, 327 (8%) patients underwent PCI within 1 year before TAVR, 38 (1%) had PCI the same day as TAVR and 15 (0.5%) had PCI within 2 months after TAVR. Overall, among patients who received both PCI and TAVR (n = 380), history of previous CABG (HR:0.501; p = .001), higher BMI at TAVR (HR:0.970; p = .038), and statin therapy after TAVR (HR:0.660, p = .037) were independently associated with lower MACCE while warfarin therapy after TAVR was associated with a higher risk of MACCE (HR:1.779, p = .017). Patients who received PCI within 1 year before TAVR had similar baseline demographics, STS scores, clinical risk factors when compared to patients receiving PCI with/after TAVR. Both groups were similar in PCI (Syntax Score, ACC/AHA lesion class) and TAVR (valve types, access) related variables. There were no significant differences in terms of MACCE (log rank p = .550), all-cause mortality (log rank p = .433), strokes (log rank p = .153), and repeat PCI (log rank p = .054) in patients who underwent PCI with/after TAVR when compared to patients who received PCI before TAVR. CONCLUSION: Among patients who underwent both PCI and TAVR, history of CABG, higher BMI, and statin therapy had lower, while those discharged on warfarin, had higher adverse event rates. Adverse events rates were similar regardless of timing of PCI.

Oral Calcium Supplements Associate With Serial Coronary Calcification: Insights From Intravascular Ultrasound.

OBJECTIVES: This study sought to evaluate and assess the extent of serial coronary artery calcification in response to oral calcium supplementation. BACKGROUND: Oral calcium supplements are frequently used despite their cardiovascular safety remaining controversial. Their effects on serial coronary calcification are not well established. METHODS: In a post hoc patient-level analysis of 9 prospective randomized trials using serial coronary intravascular ultrasound, changes in serial percentage of atheroma volume (PAV) and calcium indices (CaI) were compared in matched segments of patients coronary artery disease who were receiving concomitant calcium supplements (n = 447) and in those who did not receive supplements (n = 4,700) during an 18- to 24-month trial period. RESULTS: Patients (mean age 58 ± 9 years; 73% were men; 43% received concomitant high-intensity statins) demonstrated overall annualized changes in PAV and CaI with a mean of -0.02 ± 1.9% (p = 0.44) and a median of 0.02 (interquartile range: 0.00 to 0.06) (p < 0.001) from baseline, respectively. Following propensity-weighted mixed modeling adjusting for treatment and a range of demographic, clinical, ultrasonic, and laboratory parameters (including but not limited to sex, race, baseline, and annualized change in PAV, baseline CaI, concomitant high-intensity statins, diabetes mellitus, renal function), there were no significant between-group differences in annualized changes in PAV (least-squares mean: 0.09; 95% confidence interval [CI]: -0.20 to 0.37 vs. 0.01; 95% CI: -0.27 to 0.29; p = 0.092) according to calcium supplement intake. Per a multivariable logistic regression model accounting for the range of covariates described, calcium supplementation independently associated with an increase in annualized CaI (odds ratio: 1.15; 95% CI: 1.05 to 1.26; p = 0.004). CONCLUSIONS: Oral calcium supplementation may increase calcium deposition in the coronary vasculature independent of changes in atheroma volume. The impact of these changes on plaque stability and cardiovascular outcomes requires further investigation.

Impact of tricuspid regurgitation on postoperative outcomes after non-cardiac surgeries.

Objective: Tricuspid regurgitation (TR) severity has known adverse implications, its impact on patients undergoing non-cardiac surgery (NCS) remains unclear. We sought to determine the impact of TR on patient outcomes after NCS. Methods: We performed a retrospective cohort study in patients undergoing NCS. Outcomes in patients with moderate or severe TR were compared with no/trivial TR after adjusting for baseline characteristics and revised cardiac risk index (RCRI). The primary outcome was defined as 30-day mortality and heart failure (HF), while the secondary outcome was long-term mortality. Results: Of the 7064 patients included, 312 and 80 patients had moderate and severe TR, respectively. Thirty-day mortality was higher in moderate TR (adjusted OR 2.44, 95% CI 1.25 to 4.76) and severe TR (OR 2.85, 95% CI 1.04 to 7.79) compared with no/trivial TR. There was no difference in 30-day HF in patients with moderate TR (OR 1.48, 95% CI 0.90 to 2.44) or severe TR (OR 1.42, 95% CI 0.60 to 3.39). The adjusted HR for long-term mortality in moderate TR was 1.55 (95% CI 1.31 to 1.82) and 1.87 (95% CI 1.40 to 2.50) for severe TR compared with no/trivial TR. Conclusion: Increasing TR severity has higher postoperative 30-day mortality in patients undergoing NCS, independent of RCRI risk factors, ejection fraction or mitral regurgitation. Severity of TR should be considered in risk stratification for patients undergoing NCS.

Outcomes of Transcatheter Aortic Valve Replacement in Patients With Bicuspid Aortic Valve Disease: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: Patients with bicuspid aortic valve (AV) stenosis were excluded from the pivotal evaluations of transcatheter AV replacement (TAVR) devices. We sought to evaluate the outcomes of TAVR in patients with bicuspid AV stenosis in comparison with those with tricuspid AV stenosis. METHODS: We used data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (November 2011 through November 2018) to determine device success, procedural outcomes, post-TAVR valve performance, and in-hospital clinical outcomes (mortality, stroke, and major bleeding) according to valve morphology (bicuspid versus tricuspid). Results were stratified by older and current (Sapien 3 and Evolut R) generation valve prostheses. Medicare administrative claims were used to evaluate mortality and stroke to 1 year among eligible individuals (≥65 years). RESULTS: After exclusions, there were 170 959 eligible procedures at 593 sites during the specified interval. Of these, 5412 TAVR procedures (3.2%) were performed in patients with bicuspid AV, including 3705 with current-generation devices. In comparison with patients with tricuspid valves, patients with bicuspid AV were younger and had a lower Society of Thoracic Surgeons Predicted Risk of Operative Mortality score. When current-generation devices were used to treat patients with bicuspid AV, device success increased (93.5 versus 96.3; P=0.001) and the incidence of 2+ aortic insufficiency declined (14.0% versus 2.7%; P<0.001) in comparison with older-generation devices. With current-generation devices, device success was slightly lower in the bicuspid (versus tricuspid) AV group (96.3% in bicuspid versus 97.4% in tricuspid, P=0.07), with a slightly higher incidence of residual moderate or severe aortic insufficiency among patients with bicuspid AV (2.7% versus 2.1%; P<0.001). A lower 1-year adjusted risk of mortality (hazard ratio, 0.88 [95% CI, 0.78-0.99]) was observed for patients with bicuspid AV versus patients with tricuspid AV in the Medicare-linked cohort, whereas no difference was observed in the 1-year adjusted risk of stroke (hazard ratio, 1.14 [95% CI, 0.94-1.39]). CONCLUSIONS: Using current-generation devices, procedural, postprocedural, and 1-year outcomes were comparable following TAVR for bicuspid AV versus tricuspid AV disease. With newer-generation devices, TAVR is a viable treatment option for patients with bicuspid AV disease.

Incidence and Outcomes of Acute Coronary Syndrome After Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study sought to address a knowledge gap by examining the incidence, timing, and predictors of acute coronary syndrome (ACS) after transcatheter aortic valve replacement (TAVR) in Medicare beneficiaries. BACKGROUND: Evidence about incidence and outcomes of ACS after TAVR is scarce. METHODS: We identified Medicare patients who underwent TAVR from 2012 to 2017 and were admitted with ACS during follow-up. We compared outcomes based on the type of ACS: ST-segment elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), and unstable angina. In patients with non-ST-segment elevation ACS, we compared outcomes based on the treatment strategy (invasive vs. conservative) using inverse probability weighting analysis. RESULTS: Out of 142,845 patients with TAVR, 6,741 patients (4.7%) were admitted with ACS after a median time of 297 days (interquartile range: 85 to 662 days), with 48% of admissions occurring within 6 months. The most common presentation was NSTEMI. Predictors of ACS were history of coronary artery disease, prior revascularization, diabetes, valve-in-TAVR, and acute kidney injury. STEMI was associated with higher 30-day and 1-year mortality compared with NSTEMI (31.4% vs. 15.5% and 51.2% vs. 41.3%, respectively; p < 0.01). Overall, 30.3% of patients with non-ST-segment elevation ACS were treated with invasive approach. On inverse probability weighting analysis, invasive approach was associated with lower adjusted long-term mortality (adjusted hazard ratio: 0.69; 95% confidence interval: 0.66 to 0.73; p < 0.01) and higher risk of repeat revascularization (adjusted hazard ratio: 1.29; 95% confidence interval: 1.16 to 1.43; p < 0.001). CONCLUSIONS: After TAVR, ACS is infrequent (<5%), and the most common presentation is NSTEMI. Occurrence of STEMI after TAVR is associated with a high mortality with nearly one-third of patients dying within 30 days. Optimization of care is needed for post-TAVR ACS patients and if feasible, invasive approach should be considered in these high-risk patients.

Evaluation of System Modelling Techniques for Waste Identification in Lean Healthcare Applications.

PURPOSE: Waste identification plays a vital role in lean healthcare applications. While the value stream map (VSM) is among the most commonly used tools for waste identification, it may be limited to visualize the behaviour of dynamic and complex healthcare systems. To address this limitation, system modelling techniques (SMTs) can be used to provide a comprehensive picture of various system-wide wastes. However, there is a lack of evidence in the current literature about the potential contribution of SMTs for waste identification in healthcare processes. METHODS: This study evaluates the usability and utility of six types of SMTs along with the VSM. For the evaluation, interview-based questionnaires were conducted with twelve stakeholders from the outpatient clinic at the Heart and Vascular Institute at Cleveland Clinic Abu Dhabi. RESULTS: VSM was found to be the most useful diagram in waste identification in general. However, some SMTs that represent the system behaviour outperformed the VSM in identifying particular waste types, e.g., communication diagram in identifying over-processing waste and flow diagram in identifying transportation waste. CONCLUSION: As behavioural SMTs and VSM have unique strengths in identifying particular waste types, the use of multiple diagrams is recommended for a comprehensive waste identification in lean. However, limited resources and time, as well as limited experience of stakeholders with SMTs, may still present obstacles for their potential contribution in lean healthcare applications.

Inter- and intrasite variability of mortality and stroke for sites performing both surgical and transcatheter aortic valve replacement for aortic valve stenosis in intermediate-risk patients.

OBJECTIVES: Multisite procedure-based randomized trials may be confounded by performance variability and variability among sites. Therefore, we studied variability in mortality and stroke after patients were randomized to surgical (SAVR) or transcatheter aortic valve replacement (TAVR) in the Placement of Aortic Transcatheter Valves-2A (PARTNER-2A) randomized trial. METHODS: Patients at intermediate risk for SAVR were randomized to SAVR (n = 1017) or TAVR (n = 1011) with a SAPIEN XT device (Edwards Lifesciences, Irvine, Calif) at 54 sites. Patients were followed to 2 years. A mixed-effect model quantified variability at intersite and intrasite levels. RESULTS: There were 336 deaths (SAVR 170, TAVR 166) and 176 strokes (SAVR 85, TAVR 91). Intersite variability for mortality was similar across sites for SAVR (hazard ratios ranging from 0.52-1.93 among sites) and TAVR (hazard ratios ranging from 0.49-2.03), but intersite variability for stroke was greater for SAVR (hazard ratios ranging from 0.44-2.26) than for TAVR (no detectable variability). Case mix and lower site trial volume accounted for 37% of mortality intersite variability for SAVR and 73% for TAVR, but only 14% for stroke for SAVR. Intrasite mortality hazard ratios demonstrated all but 1 site's 95% confidence interval overlapped 1.0, indicating generally similar SAVR and TAVR mortalities within sites. CONCLUSIONS: Intersite variability was similar for mortality in SAVR and TAVR, but variability for stroke was greater for SAVR than for TAVR. Intrasite events were similar for both SAVR and TAVR. These findings suggest that in performance-based trials, site variability and its sources should be taken into account in analyzing and interpreting trial results.