Risk and predictors of mortality after implantable cardioverter-defibrillator implantation in patients with sarcoid cardiomyopathy.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) are recommended for patients with cardiac sarcoidosis (CS) with an indication for pacing, prior ventricular arrhythmias, cardiac arrest, or left ventricular ejection fraction <35%, but data on outcomes are limited. METHODS: Using data from the National Cardiovascular Data Registry ICD Registry between April 1, 2010 and December 31, 2015, we evaluated a propensity matched cohort of CS patients implanted with ICDs versus non-ischemic cardiomyopathies (NICM). We compared mortality using Kaplan-Meier survival curves and Cox proportional hazards models. RESULTS: We identified 1,638 patients with CS and 8,190 propensity matched patients with NICM. The rate of death at 1 and 2 years was similar in patients with CS and patients with NICM (5.2% vs 5.4%, P = 0.75 and 9.0% vs 9.3%, P = 0.72, respectively). After adjusting for other covariates, patients with CS had similar mortality at 2 years after ICD implantations compared with NICM patients (RR 1.03, 95% CI 0.87-1.23). Among patients with CS, multivariable logistic regression identified 6 factors significantly associated with increased 2-year mortality: presence of heart failure (HR 1.92, 95% CI 1.44-3.22), New York Heart Association (NYHA) Class III heart failure (HR 1.68, 95% CI 1.16-2.45), NYHA Class IV heart failure (HR 3.08, 95% CI 1.49-6.39), atrial fibrillation/flutter (HR 1.66, 95% CI 1.17-2.35), chronic lung disease (HR 1.64, 95% CI 1.17-2.29), creatinine >2.0 mg/dL (HR 4.07, 95% CI 2.63-6.30), and paced rhythm (HR 2.66, 95% CI 1.07-6.59). CONCLUSION: Mortality following ICD implantation was similar in CS patients compared with propensity matched NICM patients. Presence of heart failure, NYHA class, atrial fibrillation/flutter, chronic lung disease, renal dysfunction, and paced rhythm at time of implantation were all predictors of increased 2-year mortality among CS patients with ICDs.

Trends in ICD Implantations and in-Hospital Outcomes After DOJ Investigation.

BACKGROUND: The Department of Justice (DOJ) investigated implantable cardioverter-defibrillators (ICDs) not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria, resulting in increased adherence to the NCD criteria. Trends of the specific reasons for patients not meeting the NCD criteria and in-hospital outcomes for those patients are not known. METHODS AND RESULTS: We analyzed 300,151 primary-prevention ICDs from 2007-2015 at 1809 hospitals. We calculated the rates of in-hospital adverse events and the proportion of ICDs not meeting the 4 NCD criteria before and after the announcement of the DOJ investigation, stratified by whether hospitals paid settlements to the DOJ. Most reductions in the use of devices in patients not meeting NCD criteria were in patients with recently diagnosed heart failure (15.5%-6.8% for settled; 13.5%-7.3% for nonsettled) and who had had a recent myocardial infarction (8.4%-1.3% for settled; 7.4% to 1.5% for nonsettled). Adverse-event rates were significantly higher for ICDs not meeting NCD criteria (odds ratio 1.26 for settled; P < 0.001; 1.18 for nonsettled; P = 0.001). CONCLUSIONS: After the investigation, there was a rapid reduction in the placement of ICDs in patients with recent acute myocardial infarction or recent diagnosis of heart failure. Patients who did not meet NCD criteria experienced more in-hospital adverse events and higher mortality rates.

Stent selection among patients with chronic kidney disease: Results from the NCDR CathPCI Registry.

OBJECTIVES: This study sought to define contemporary rates of drug eluting stent (DES) usage in patients with chronic kidney disease (CKD). BACKGROUND: Among patients with CKD undergoing percutaneous coronary interventions (PCIs), outcomes are superior for those who receive DES compared to those who receive bare metal stents (BMSs). However, perceived barriers may limit the use of DES in this population. METHODS: All adult PCI cases from the NCDR CathPCI Registry involving coronary stent placement between July 1, 2009 and December 31, 2015 were analyzed. The rate of DES usage was then compared among four groups, stratified by CKD stage (I/II, III, IV, and V). Subgroup analysis was conducted based on PCI status and indication. Cases were linked to Medicare claims data to assess 1-year mortality. RESULTS: A total of 3,650,333 PCI cases met criteria for analysis. DES usage significantly declined as renal function worsened (83.0%, 79.9%, 75.6%, and 75.6%, respectively, in the four CKD stages; p < .001). DES usage was universally lower across the four groups in the setting of ST-Elevation Myocardial Infarction (STEMI) (70.6%, 66.5%, 58.7%, 58.0%; p < .001) and higher in the setting of elective PCI (87.6%, 84.9%, 82.3%, 77.9%; p < .0001). DES was associated with improved 1-year survival, and usage increased over time across each group. CONCLUSIONS: DESs are underutilized in patients with advanced renal dysfunction. Although DES usage has increased over time, variation still exists between patients with normal renal function and those with CKD.

Association Between Industry Payments to Physicians and Device Selection in ICD Implantation.

Importance: Little is known about the association between industry payments and medical device selection. Objective: To examine the association between payments from device manufacturers to physicians and device selection for patients undergoing first-time implantation of a cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D). Design, Setting, and Participants: In this cross-sectional study, patients who received a first-time ICD or CRT-D device from any of the 4 major manufacturers (January 1, 2016-December 31, 2018) were identified. The data from the National Cardiovascular Data Registry ICD Registry was linked with the Open Payments Program's payment data. Patients were categorized into 4 groups (A, B, C, and D) corresponding to the manufacturer from which the physician who performed the implantation received the largest payment. For each patient group, the proportion of patients who received a device from the manufacturer that provided the largest payment to the physician who performed implantation was determined. Within each group, the absolute difference in proportional use of devices between the manufacturer that made the highest payment and the proportion of devices from the same manufacturer in the entire study cohort (expected prevalence) was calculated. Exposures: Manufacturers' payments to physicians who performed an ICD or CRT-D implantation. Main Outcomes and Measures: The primary outcome of the study was the manufacturer of the device used for the implantation. Results: Over a 3-year period, 145 900 patients (median age, 65 years; 29.6% women) received ICD or CRT-D devices from the 4 manufacturers implanted by 4435 physicians at 1763 facilities. Among these physicians, 4152 (94%) received payments from device manufacturers ranging from $2 to $323 559 with a median payment of $1211 (interquartile range, $390-$3702). Between 38.5% and 54.7% of patients received devices from the manufacturers that had provided physicians with the largest payments. Patients were substantially more likely to receive devices made by the manufacturer that provided the largest payment to the physician who performed implantation than they were from each other individual manufacturer. The absolute differences in proportional use from the expected prevalence were 22.4% (95% CI, 21.9%-22.9%) for manufacturer A; 14.5% (95% CI, 14.0%-15.0%) for manufacturer B; 18.8% (95% CI, 18.2%-19.4%) for manufacturer C; and 30.6% (95% CI, 30.0%-31.2%) for manufacturer D. Conclusions and Relevance: In this cross-sectional study, a large proportion of ICD or CRT-D implantations were performed by physicians who received payments from device manufacturers. Patients were more likely to receive ICD or CRT-D devices from the manufacturer that provided the highest total payment to the physician who performed an ICD or CRT-D implantation than each other manufacturer individually.

Adoption of the transradial approach for percutaneous coronary intervention and rates of vascular complications following transfemoral procedures: Insights from NCDR.

OBJECTIVES: This study was designed to examine the association between adopting the transradial approach for percutaneous coronary intervention (PCI) and rates of vascular complications following transfemoral PCI. BACKGROUND: Recent studies raised concerns that operators adopting the transradial approach may lose their transfemoral access skills and experience increased rates of vascular complications. METHODS: Retrospective analysis of data from the NCDR CathPCI Registry to examine the rates of vascular complications among physicians who were femoral operators (>90% of cases) in 2010-2011 and later adopted the transradial approach to PCI among low-, intermediate-, or high-level adopters (≤33%, 34-66%, and >66%, respectively) in 2014-2015. Propensity score matching was used to control for confounding factors. RESULTS: A total of 1,704,708 procedures performed by 4,697 operators were included. Most operators were low-level adopters (80.7%), followed by intermediate (15.7) and high-level adopters (3.6%). Compared to the preadoption period, vascular complications of transfemoral PCIs following transradial adoption increased among low-level adopters (1.29%-1.59%, adjusted OR [95% CI]: 1.24[1.20-1.28], P < 0.001), intermediate-level adopters (1.37%-1.92%, adjusted OR 1.40[1.29-1.53], P < 0.001), and high-level adopters (1.54%-1.93%, adjusted OR 1.26[1.00-1.58], P = 0.053).In the post-adoption period, there was increase in access site bleeding that is likely due to change in registry definition. There was no increase in hematomas, retroperitoneal bleeding or other vascular complications. CONCLUSIONS: Adoption of the transradial approach for PCI is not associated with clinically meaningful increase in rates of vascular complications of transfemoral PCIs.

Ventricular septal rupture complicating acute myocardial infarction: Incidence, treatment, and outcomes among medicare beneficiaries 1999-2014.

OBJECTIVES: The present study was designed to assess whether the incidence and outcomes of VSR-AMI have changed in the era of timely primary PCI. BACKGROUND: Ventricular septal rupture (VSR) is a rare but frequently fatal complication of acute myocardial infarction (AMI). METHODS: We conducted a retrospective cohort study of all Medicare fee-for-service beneficiaries from 1999 to 2014 to examine trends in the incidence, surgical and percutaneous repair, and 30-day and 1-year mortality of VSR-AMI. RESULTS: The annual incidence of VSR-AMI hospitalization declined by 41.6% from 197 patients per 100,000 AMIs in 1999 to 115 patients per 100,000 AMIs in 2014 (P < 0.001). The 30-day VSR-AMI repair rate decreased from 49.9% in 1999 to 33.3% in 2014 (P < 0.001). In 2014, 82.9% of repairs were performed surgically and 17.1% percutaneously. VSR-AMI mortality rates were high (60.2% at 30 days; 68.5% at 1 year) and changed minimally over the study period with adjusted 30-day mortality per year Odds Ratio (OR) 0.99 (95% confidence interval [CI] 0.98-1.01) and adjusted 1-year mortality per year OR 0.98 (95% CI 0.97-1.00). Across the 16 years of data, unadjusted mortality rates were lower in patients undergoing repair than in unrepaired patients at 30 days (mean 51.7% and 65.7%, P ≤ 0.01) and 1 year (mean 62.0% and 72.8%, P < 0.01). CONCLUSIONS: In the era of increased timely primary PCI, the incidence of VSR-AMI hospitalization declined but its associated mortality rate remained high. Rates of VSR repair decreased from 1999 to 2014 despite increased use of percutaneous repair.

A Qualitative Study of Multidisciplinary Providers' Experiences With the Transfer Process for Injured Children and Ideas for Improvement.

OBJECTIVE: Most injured children initially present to a community hospital, and many will require transfer to a regional pediatric trauma center. The purpose of this study was 1) to explore multidisciplinary providers' experiences with the process of transferring injured children and 2) to describe proposed ideas for process improvement. METHODS: This qualitative study involved 26 semistructured interviews. Subjects were recruited from 6 community hospital emergency departments and the trauma and transport teams of a level I pediatric trauma center in New Haven, Conn. Participants (n = 34) included interprofessional providers from sending facilities, transport teams, and receiving facilities. Using the constant comparative method, a multidisciplinary team coded transcripts and collectively refined codes to generate recurrent themes across interviews until theoretical saturation was achieved. RESULTS: Participants reported that the transfer process for injured children is complex, stressful, and necessitates collaboration. The transfer process was perceived to involve numerous interrelated components, including professions, disciplines, and institutions. The 5 themes identified as areas to improve this transfer process included 1) Creation of a unified standard operating procedure that crosses institutions/teams, 2) Enhancing 'shared sense making' of all providers, 3) Improving provider confidence, expertise, and skills in caring for pediatric trauma transfer cases, 4) Addressing organization and environmental factors that may impede/delay transfer, and 5) Fostering institutional and personal relationships. CONCLUSIONS: Efforts to improve the transfer process for injured children should be guided by the experiences of and input from multidisciplinary frontline emergency providers.

Association of the US Department of Justice Investigation of Implantable Cardioverter-Defibrillators and Devices Not Meeting the Medicare National Coverage Determination, 2007-2015.

Importance: The US Department of Justice (DOJ) conducted an investigation into implantable cardioverter-defibrillators (ICDs) not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria. Objective: To examine changes in the proportion of initial primary prevention ICDs that did not meet NCD criteria following the announcement of the DOJ investigation at hospitals that reached settlements (settlement hospitals) and those that did not (nonsettlement hospitals). Design, Setting, and Participants: Multicenter, longitudinal, serial cross-sectional analysis of 300 151 initial primary prevention ICDs among Medicare beneficiaries from January 1, 2007, through December 31, 2015, at 1809 US hospitals in the National Cardiovascular Data Registry (NCDR) ICD Registry, of which 452 hospitals (with 99 591 primary prevention ICDs) reached settlements with the DOJ. Exposures: The DOJ investigation announcement in 2010. Main Outcomes and Measures: Proportion of initial primary prevention ICDs not meeting NCD criteria. Results: In January 2007, the proportion of initial ICDs not meeting NCD criteria was 25.8% (95% CI, 24.7% to 26.8%) at settlement hospitals and 22.8% (95% CI, 22.1% to 23.5%) at nonsettlement hospitals (P < .001). Over the study period, there was a 62.7% (95% CI, 59.2% to 66.1%) relative decrease and 16.1% (95% CI, 14.8% to 17.5%) absolute decrease in the proportion of ICDs not meeting NCD criteria at settlement hospitals compared with a 53.2% (95% CI, 50.4% to 56.0%) relative decrease and 12.1% (95% CI, 11.2% to 13.0%) absolute decrease in proportion at nonsettlement hospitals (P < .001 for both; P for interaction < .001). Trends significantly differed between hospital groups only in the period following the announcement of the DOJ investigation (January 2010-June 2011) [corrected], with larger and more rapid decreases at settlement hospitals (P for interaction = .01). Over the study period, there was a 32.8% (95% CI, 29.9% to 35.7%) relative decrease and a 1703 ICDs (95% CI, 1520 to 1886) absolute decrease in the volume of primary prevention ICDs implanted at settlement hospitals compared with a 17.4% (95% CI, 14.8% to 20.0%) relative decrease and a 1495 ICDs (95% CI, 1249 to 1741) absolute decrease in volume at nonsettlement hospitals (P < .001 for both; P for interaction < .001), with more modest decreases or slight increases in secondary prevention ICD volume. These patterns were similar when examining ICD utilization among non-Medicare beneficiaries. Conclusions and Relevance: From 2007 through 2015, the volume of primary prevention implantable cardioverter-defibrillators and the proportion of devices not meeting the Centers for Medicare & Medicaid Services National Coverage Determination criteria decreased at all hospitals with substantially larger decreases at hospitals that reached settlements in the US Department of Justice investigation. These patterns extended to implantable cardioverter-defibrillators placed in non-Medicare beneficiaries, which were not the focus of the US Department of Justice investigation.

Development and validation of a simple risk score to predict 30-day readmission after percutaneous coronary intervention in a cohort of medicare patients.

OBJECTIVES: To develop a risk model that can be used to identify PCI patients at higher risk of readmission who may benefit from additional resources at the time of discharge. BACKGROUND: A high proportion of patients undergoing PCI are readmitted within 30 days of discharge. METHODS: The sample comprised patients aged ≥65 years who underwent PCI at a CathPCI Registry®-participating hospital and could be linked with 100% Medicare fee-for-service claims between 01/2007 and 12/2009. The sample (n = 388,078) was randomly divided into risk score development (n = 193,899) and validation (n = 194,179) cohorts. We did not count as readmissions those associated with staged revascularization procedures. Multivariable logistic regression models using stepwise selection models were estimated to identify variables independently associated with all-cause 30-day readmission. RESULTS: The mean 30-day readmission rates for the development (11.36%) and validation (11.35%) cohorts were similar. In total, 19 variables were significantly associated with risk of 30-day readmission (P < 0.05), and model c-statistics were similar in the development (0.67) and validation (0.66) cohorts. The simple risk score based on 14 variables identified patients at high and low risk of readmission. Patients with a score of ≥13 (15.4% of sample) had more than an 18.5% risk of readmission, while patients with a score ≤6 (41.9% of sample) had less than an 8% risk of readmission. CONCLUSION: Among PCI patients, risk of readmission can be estimated using clinical factors present at the time of the procedure. This risk score may guide clinical decision-making and resource allocation for PCI patients at the time of hospital discharge. © 2016 Wiley Periodicals, Inc.

New directions for diabetes prevention and management in behavioral medicine.

Accelerating diabetes rates have resulted in a global public health epidemic. Lifestyle change is a cornerstone of care, yet regimen demands may result in adherence difficulties. Distress, depression, and other psychosocial concerns are higher in those with diabetes. While interventions, such as the Diabetes Prevention Program appear to be effective, further research is needed to support the translation of interventions to prevent diabetes. Studies assessing optimal approaches to promoting effective decision making, coping and adherence are needed. More information is needed to evaluate the influence and potential of emerging technologies on intervention delivery and quality of life in children and adults with diabetes. Theoretically informed, interdisciplinary studies that consider ecological models are needed to develop a roadmap for policies and diabetes management recommendations. Reduction of diabetes-related health disparities is a critical area for future studies. Behavioral medicine scientists and practitioners are poised to address these and other proposed future research directions to advance diabetes prevention and management.

Preparing tomorrow's behavioral medicine scientists and practitioners: a survey of future directions for education and training.

Behavioral medicine training is due for an overhaul given the rapid evolution of the field, including a tight funding climate, changing job prospects, and new research and industry collaborations. The purpose of the present study was to collect responses from trainee and practicing members of a multidisciplinary professional society about their perceptions of behavioral medicine training and their suggestions for changes to training for future behavioral medicine scientists and practitioners. A total of 162 faculty and 110 students (total n = 272) completed a web-based survey on strengths of their current training programs and ideas for changes. Using a mixed-methods approach, the survey findings are used to highlight seven key areas for improved preparation of the next generation of behavioral medicine scientists and practitioners, which are grant writing, interdisciplinary teamwork, advanced statistics and methods, evolving research program, publishable products from coursework, evolution and use of theory, and non-traditional career paths.

Care Transitions Between Hospitals and Skilled Nursing Facilities: Perspectives of Sending and Receiving Providers.

BACKGROUND: One in four Medicare patients hospitalized for acute medical illness is discharged to a skilled nursing facility (SNF); 23% of these patients are readmitted to the hospital within 30 days. The care transition from hospital to SNF is often marked by disruptions in care and poor communication among hospital and SNF providers. A study was conducted to identify the perspectives of sending and receiving providers regarding care transitions between the hospital and the SNF. METHODS: Hospital (N = 25) and SNF (N = 16) providers participated in qualitative interviews assessing patient transfers and experiences with unplanned hospital readmissions. Data were analyzed by a multidisciplinary coding team using the constant comparison method. RESULTS: Four main themes emerged: increasing patient complexity, identifying an optimal care setting, rising financial pressure, and barriers to effective communication. The data highlighted hospital and SNF providers' shared concerns about patient-level risk factors and escalating costs of care. The data also identified issues that separate hospital and SNF providers, including different access to resources and information. CONCLUSION: Hospital and SNF providers are challenged to meet the needs of complex patients. They are asked to establish comprehensive care plans for patients with significant medical and psychosocial issues while navigating tense relationships between health care institutions and rising financial pressures. The concerns of both hospital and SNF providers must be considered in order to develop practices that can improve the quality, cost, and safety of care transitions.

Association of Physician Certification in Interventional Cardiology With In-Hospital Outcomes of Percutaneous Coronary Intervention.

BACKGROUND: The value of American Board of Internal Medicine certification has been questioned. We evaluated the Association of Interventional Cardiology certification with in-hospital outcomes of patients undergoing percutaneous coronary intervention (PCI) in 2010. METHODS AND RESULTS: We identified physicians who performed ≥10 PCIs in 2010 in the CathPCI Registry and determined interventional cardiology (ICARD) certification status using American Board of Internal Medicine data. We compared in-hospital outcomes of patients treated by certified and noncertified physicians using hierarchical multivariable models adjusted for differences in patient characteristics and PCI volume. Primary end points were all-cause in-hospital mortality and bleeding complications. Secondary end points included emergency coronary artery bypass grafting, vascular complications, and a composite of any adverse outcome. With 510,708 PCI procedures performed by 5175 physicians, case mix and unadjusted outcomes were similar among certified and noncertified physicians. The adjusted risks of in-hospital mortality (odds ratio, 1.10; 95% confidence interval, 1.02-1.19) and emergency coronary artery bypass grafting (odds ratio, 1.32; 95% confidence interval, 1.12-1.56) were higher in the non-ICARD-certified group, but the risks of bleeding and vascular complications and the composite end point were not statistically significantly different between groups. CONCLUSIONS: We did not observe a consistent association between ICARD certification and the outcomes of PCI procedures. Although there was a significantly higher risk of mortality and emergency coronary artery bypass grafting in patients treated by non-ICARD-certified physicians, the risks of vascular complications and bleeding were similar. Our findings suggest that ICARD certification status alone is not a strong predictor of patient outcomes and indicate a need to enhance the value of subspecialty certification.

Efficacy and implementation of an Internet psychoeducational program for teens with type 1 diabetes.

OBJECTIVE: The purpose of the study was to evaluate the participation and preliminary efficacy of an Internet psychoeducational program (Teens.Connect) shown to be efficacious under controlled conditions compared with an open-access diabetes website for youth (Planet D) on the primary outcomes of A1C and quality of life (QoL), and secondary outcomes of psychosocial and behavioral factors. RESEARCH DESIGN AND METHODS: Teens with type 1 diabetes (n = 124, 11-14 yr) from two clinical sites were randomly prescribed one of the programs and completed baseline, 3-month and 6-month data. A1C was obtained from clinic records. Participation data included number of log ins, posts to the discussion board, and lessons completed (Teens.Connect only). Descriptive and mixed model analyses were used. RESULTS: Eighty-five percent (85%) of consented teens registered for their prescribed program. Satisfaction and log ins were similar between groups (satisfaction ranged 3.3-3.5/5; mean log ins = 14/teen). Posts to the discussion forum were higher in Planet D (mean = 28 vs. 19). Participation in the Teens.Connect lessons was low, with only 69% of teens completing any lesson. After 6 months there were no significant differences in A1C, QoL or secondary outcomes between groups. Teens in the Teens.Connect group reported lower perceived stress over time (p < 0.01). CONCLUSIONS: Teens do not actively participate in an Internet psychoeducational program when they do not have frequent reminders, which may have contributed to a lack of treatment effect. Teens have many competing demands. Strategic implementation that includes targeted reminders and family support may be necessary to assure participation and improvement in health outcomes.

Weight status, gender, and race/ethnicity: are there differences in meeting recommended health behavior guidelines for adolescents?

Healthy behaviors including limited screen time (ST), high physical activity (PA), and adequate fruits and vegetables consumption (FV) are recommended for adolescents, but it is unclear how gender, race/ethnicity, and weight status relate to these public health guidelines in diverse urban adolescents. Participants (N = 384) were recruited from three public high schools in or near New Haven, Connecticut. Descriptive statistics and logistic regression analyses were conducted. Most adolescents exceeded recommended levels of ST (70.5%) and did not meet guidelines for PA (87.2%) and FV (72.6%). Only 3.5% of the sample met all three guidelines. Boys were more likely to meet guidelines for PA (p < .01), while girls were engaged in less ST (p < .001). Black, non-Latinos were less likely to meet PA guidelines (p < .05). There were no significant differences in meeting ST, PA, or FV guidelines by weight status for the overall sample or when stratified by gender or race/ethnicity. We found alarmingly low levels of healthy behaviors in normal weight and overweight/obese adolescents.

Procedure Volume and Outcomes With WATCHMAN Left Atrial Appendage Occlusion.

BACKGROUND: Procedure volumes are associated with outcomes for many cardiovascular procedures, leading to guidelines on minimum volume thresholds for certain procedures; however, the volume-outcome relationship with left atrial appendage occlusion is poorly understood. As such, we sought to determine the relationship between hospital and physician volume and WATCHMAN left atrial appendage occlusion procedural success overall and with the new generation WATCHMAN FLX device. METHODS: We performed an analysis of WATCHMAN procedures (January 2019 to October 2021) from the National Cardiovascular Data Registry LAAO Registry. Three-level hierarchical generalized linear models were used to assess the adjusted relationship between procedure volume and procedural success (device released with peridevice leak <5 mm, no in-hospital major adverse events). RESULTS: Among 87 480 patients (76.2±8.0 years; 58.8% men; mean CHA2DS2-VASc score, 4.8±1.5) from 693 hospitals, the procedural success rate was 94.2%. With hospital volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (odds ratio [OR], 0.66 [CI, 0.57-0.77]) and Q2 (OR, 0.78 [CI, 0.69-0.90]) but not Q3 (OR, 0.95 [CI, 0.84-1.07]). With physician volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (OR, 0.72 [CI, 0.63-0.82]), Q2 (OR, 0.79 [CI, 0.71-0.89]), and Q3 (OR, 0.88 [CI, 0.79-0.97]). Among WATCHMAN FLX procedures, there was attenuation of the volume-outcome relationships, with statistically significant but modest absolute differences of only ≈1% across volume quartiles. CONCLUSIONS: In this contemporary national analysis, greater hospital and physician WATCHMAN volumes were associated with increased procedure success. The WATCHMAN FLX transition was associated with increased procedural success and less heterogeneity in outcomes across volume quartiles. These findings indicate the importance of understanding the volume-outcome relationship for individual left atrial appendage occlusion devices.

Predicting Major Adverse Events in Patients Undergoing Transcatheter Left Atrial Appendage Occlusion.

BACKGROUND: The National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry (LAAO) includes the vast majority of transcatheter LAAO procedures performed in the United States. The objective of this study was to develop a model predicting adverse events among patients undergoing LAAO with Watchman FLX. METHODS: Data from 41 001 LAAO procedures with Watchman FLX from July 2020 to September 2021 were used to develop and validate a model predicting in-hospital major adverse events. Randomly selected development (70%, n=28 530) and validation (30%, n=12 471) cohorts were analyzed with 1000 bootstrapped samples, using forward stepwise logistic regression to create the final model. A simplified bedside risk score was also developed using this model. RESULTS: Increased age, female sex, low preprocedure hemoglobin, no prior attempt at atrial fibrillation termination, and increased fall risk most strongly predicted in-hospital major adverse events and were included in the final model along with other clinically relevant variables. The median in-hospital risk-standardized adverse event rate was 1.50% (range, 1.03%-2.84%; interquartile range, 1.42%-1.64%). The model demonstrated moderate discrimination (development C-index, 0.67 [95% CI, 0.65-0.70] and validation C-index, 0.66 [95% CI, 0.62-0.70]) with good calibration. The simplified risk score was well calibrated with risk of in-hospital major adverse events ranging from 0.26% to 3.90% for a score of 0 to 8, respectively. CONCLUSIONS: A transcatheter LAAO risk model using National Cardiovascular Data Registry and LAAO Registry data can predict in-hospital major adverse events, demonstrated consistency across hospitals and can be used for quality improvement efforts. A simple bedside risk score was similarly predictive and may inform shared decision-making.

Overweight and obesity in youth with type 1 diabetes.

Overweight and obesity in youth with type 1 diabetes (T1D) is now prevalent and accounts for significant health consequences, including cardiovascular complications and dual diagnosis of type 2 diabetes. Physical activity and lifestyle are modifiable and play an important role in the prevention and management of excessive weight, but it is unclear how these factors relate to overweight and obese youth with T1D. Thus, a systematic review was conducted to examine how physical activity, sedentary behavior, sleep, and diet are related to overweight/obesity in youth with T1D. Seven observational and intervention studies published between 1990 and 2013 were included in the review. Prevalence of overweight ranged from 12.5% to 33.3%. Overweight in youth with T1D was associated with infrequent napping, increased screen time, and skipping breakfast and dinner but was not related to time engaged in physical activity. Weight-related interventions indicated modest weight loss along with improved glycemic control. In light of this review, there is a need for high quality research that examines all levels of activity in youth with T1D to identify lifestyle modification targets for weight prevention and management.

Dental education practices during COVID-19: A scoping review.

INTRODUCTION: Dental education was brought to a halt with the emergence of coronavirus disease (COVID-19). Traditional dental education comprised students working closely with instructors in a clinical laboratory setting; however, public health precautions necessitated a shift to a virtual learning platform. A scoping review of dental education practices since the start of the pandemic will help to understand approaches instructors have taken to provide dental education during this unprecedented time and suggest future applications of virtual learning in dental education. METHODS: We performed an exhaustive scoping literature search of primary peer-reviewed intervention articles published between December 2019 and April 2021 using the following databases: Academic Search Premier, Cochrane Library, Embase, ERIC, LitCovid, MedEdPortal, MedRxiv, Medline, Scopus, and Web of Science. The selection process included two independent reviewers through each phase of review. Articles were categorized and analyzed by domain. RESULTS: A total of 629 articles were identified; after titles and abstracts were reviewed, 66 articles were selected for full-text review. Following full-text review, 41 articles met eligibility criteria and comprised our study sample. Articles were arranged within domains of assessment, instruction, instructional technology, and software. The advantages to online dental education included improved accessibility, willingness to accept new assessment techniques, and lower anxiety levels. Barriers included problems with technology, classroom time management, lack of student interaction, and absence of hands-on training. CONCLUSION: Evidence suggests emerging best practices in dental education during COVID-19, and recommendations for the future of virtual and distance learning in dental education.

Longitudinal Outcomes of Subcutaneous or Transvenous Implantable Cardioverter-Defibrillators in Older Patients.

BACKGROUND: The subcutaneous (S-) implantable cardioverter-defibrillator (ICD) is an alternative to the transvenous (TV-) ICD that is increasingly implanted in younger patients; data on the safety and effectiveness of the S-ICD in older patients are lacking. OBJECTIVES: The purpose of this study was to compare outcomes among older patients who received an S- or TV-ICD. METHODS: The authors compared S-ICD and single-chamber TV-ICD implants in Fee-For-Service Medicare beneficiaries using the National Cardiovascular Data Registry ICD Registry. Outcomes were ascertained from Medicare claims data. Cox regression or competing-risk models (with TV-ICD as reference) with overlap weights were used to compare death and nonfatal outcomes (device reoperation, device removal for infection, device reoperation without infection, and cardiovascular admission), respectively. Recurrent all-cause readmissions were compared using Anderson-Gill models. RESULTS: A total of 16,063 patients were studied (age 72.6 ± 5.9 years, 28.4% women, ejection fraction 28.3 ± 8.9%). Compared with TV-ICD patients (n = 15,072), S-ICD patients (n = 991, 6.2% overall) were more often Black, younger, and dialysis dependent and less likely to have history of atrial fibrillation or flutter. In adjusted analyses, there were no differences between device type and risk of all-cause mortality (HR: 1.020; 95% CI: 0.819-1.270), device reoperation (subdistribution [s] HR: 0.976; 95% CI: 0.645-1.479), device removal for infection (sHR: 0.614; 95% CI: 0.138-2.736), device reoperation without infection (sHR: 0.975; 95% CI: 0.632-1.506), cardiovascular readmission (sHR: 1.087; 95% CI: 0.912-1.295), or recurrent all-cause readmission (HR: 1.072; 95% CI: 0.990-1.161). CONCLUSIONS: In a large representative national cohort of older patients undergoing ICD implantation, risk of death, device reoperation, device removal for infection, device reoperation without infection, and cardiovascular and all-cause readmission were similar among S- and TV-ICD recipients.