Understanding the financial cost of cancer clinical trial participation.

BACKGROUND: Though financial hardship is a well-documented adverse effect of standard-of-care cancer treatment, little is known about out-of-pocket costs and their impact on patients participating in cancer clinical trials. This study explored the financial effects of cancer clinical trial participation. METHODS: This cross-sectional analysis used survey data collected in December 2022 and May 2023 from individuals with cancer previously served by Patient Advocate Foundation, a nonprofit organization providing social needs navigation and financial assistance to US adults with a chronic illness. Surveys included questions on cancer clinical trial participation, trial-related financial hardship, and sociodemographic data. Descriptive and bivariate analyses were conducted using Cramer's V to estimate the in-sample magnitude of association. Associations between trial-related financial hardship and sociodemographics were estimated using adjusted relative risks (aRR) and corresponding 95% confidence intervals (CI) from modified Poisson regression models with robust standard errors. RESULTS: Of 650 survey respondents, 18% (N = 118) reported ever participating in a cancer clinical trial. Of those, 47% (n = 55) reported financial hardship as a result of their trial participation. Respondents reporting trial-related financial hardship were more often unemployed or disabled (58% vs. 43%; V = 0.15), Medicare enrolled (53% vs. 40%; V = 0.15), and traveled >1 h to their cancer provider (45% vs. 17%; V = 0.33) compared to respondents reporting no hardship. Respondents who experienced trial-related financial hardship most often reported expenses from travel (reported by 71% of respondents), medical bills (58%), dining out (40%), or housing needs (40%). Modeling results indicated that respondents traveling >1 h vs. ≤30 min to their cancer provider had a 2.2× higher risk of financial hardship, even after adjusting for respondent race, income, employment, and insurance status (aRR = 2.2, 95% CI 1.3-3.8). Most respondents (53%) reported needing $200-$1000 per month to compensate for trial-related expenses. Over half (51%) of respondents reported less willingness to participate in future clinical trials due to incurred financial hardship. Notably, of patients who did not participate in a cancer clinical trial (n = 532), 13% declined participation due to cost. CONCLUSION: Cancer clinical trial-related financial hardship, most often stemming from travel expenses, affected almost half of trial-enrolled patients. Interventions are needed to reduce adverse financial participation effects and potentially improve cancer clinical trial participation.

Changing Strategy Between Bridge to Transplant and Destination LVAD Therapy After the First 3 Months: Analysis of the STS-INTERMACS Database.

BACKGROUND: Left ventricular assist devices (LVADs) have been implanted as bridge to transplantation (BTT), bridge to candidacy (BTC) or destination therapy (DT) on the basis of relative and absolute contraindications to transplantation. Multiple factors may lead to changes in the strategy of support after LVAD implantation. METHODS: Based on INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) 2012-2020 data, 11,262 patients survived to 3 months on continuous-flow LVADs with intent of BTT or DT. Preimplant characteristics and early events post-LVAD were analyzed in relation to changes in BTT or DT strategy during the next 12 months. RESULTS: Among 3216 BTT patients at 3 months, later transplant delisting or death without transplant occurred in 536 (16.7%) and was more common with age, profiles 1-2, renal dysfunction, and independently for prior cardiac surgery (HR 1.25, 95% CI 1.04-1.51; P = 0.02). Post-LVAD events of infections, gastrointestinal bleeding, stroke, and right heart failure as defined by inotropic therapy, predicted delisting and death, as did in-hospital location at 3 months (HR 1.67, 95% CI 1.20-2.33; P = 0.0024). Of 8046 patients surviving to 3 months with the intent of destination therapy, 750 (9.3%) subsequently underwent listing or transplantation, often with initial histories of acute HF (HR 1.70, 95% CI 1.27-2.27; P = 0.0012) or malnutrition-cachexia (1.73, 95% CI 1.14-2.63; P = 0.0099). Multiple gastrointestinal bleeding events (≥ 4) with LVAD increased transition from BTT to DT (HR 4.22, 95% CI 1.46-12.275; P = 0.0078) but also from DT to BTT (HR 5.17, 95% CI 1.92-13.9; P = 0.0011). CONCLUSIONS: Implant strategies change over time in relation to preimplant characteristics and adverse events post implant. Preimplant recognition of factors predicting later change in implant strategy will refine initial triage, whereas further reduction of post-LVAD complications will expand options, including eventual consideration of heart transplantation.

Primary or Delayed Repair for Complete Atrioventricular Septal Defect, Tetralogy of Fallot, and Ventricular Septal Defect: Relationship to Country Economic Status.

OBJECTIVE: Primary repair in the first six months of life is routine for tetralogy of Fallot, complete atrioventricular septal defect, and ventricular septal defect in high-income countries. The objective of this analysis was to understand the utilization and outcomes of palliative and reparative procedures in high versus middle-income countries. METHODS: The World Database of Pediatric and Congenital Heart Surgery identified patients who underwent surgery for: tetralogy of Fallot, complete atrioventricular septal defect, and ventricular septal defect. Patients were categorized as undergoing primary repair, repair after prior palliation, or palliation only. Country economic status was categorized as lower middle, upper middle, and high, defined by the World Bank. Multiple logistic regression models were utilized to identify independent predictors of hospital mortality. RESULTS: Economic categories included high (n = 571, 5.3%), upper middle (n = 5,342, 50%), and lower middle (n = 4,793, 49.7%). The proportion of patients and median age with primary repair were: tetralogy of Fallot, 88.6%, 17.7 months; complete atrioventricular septal defect, 83.4%, 7.7 months; and ventricular septal defect, 97.1%, ten months. Age at repair was younger in high income countries (P < .0001). Overall mortality after repair was lowest in high income countries. Risk factors for hospital mortality included prematurity, genetic syndromes, and urgent or emergent operations (all P < .05). CONCLUSIONS: Primary repair was selected in >90% of patients, but definitive repair was delayed in lower and upper middle income countries compared with high-income countries. Repair after prior palliation versus primary repair was not a risk factor for hospital mortality. Initial palliation continues to have a small but important role in the management of these three specific congenital heart defects.

Heart Transplant Outcomes After Total Artificial Heart.

BACKGROUND: We sought to compare heart transplant (HTX) outcomes from patients with a total artificial heart (TAH), biventricular assist device (BiVAD), or left ventricular assist device (LVAD) as a bridge to transplant (BTT). Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS)-Scientific Registry of Transplant Recipients (SRTR) created a dataset with TAH or durable mechanical circulatory support (MCS) who reached HTX between 2006 and 2015. METHODS: The retrospective analysis compared TAH outcomes with those with a BiVAD or LVAD before HTX. The primary outcome was posttransplant survival at 1, 36, and 60 months. Secondary outcomes included simultaneous heart-kidney transplants, donor characteristics, and mortality risk factors. INTERMACS-SRTR cohort had, at the time of HTX, 2762 patients with LVAD; 205 BiVAD (139 durable and 66 temporary RVAD); 176 TAH (6 prior HeartMate II). RESULTS: Sixty months after HTX, mortality rates were 16.5% in the total group: LVAD 15.2%, BiVAD 22.4%, and TAH 29%. Survival differed between the LVAD, the TAH, and BiVAD but not between the BiVAD and TAH groups. One-year survival and complication rates were similar across groups-there was no difference in survival by donor age in the overall cohort. There was a difference in TTD based on recipient age in the LVAD group but not in BiVAD or TAH groups. Occurrence of HTX-kidney and post-transplant dialysis were higher in the TAH versus LVAD and BiVAD groups. CONCLUSIONS: The TAH is an efficacious BTT. Refinements in technology and patient selection may improve outcomes.

The impact of obesity and LVAD-bridging on heart transplant candidate outcomes: a linked STS INTERMACS - OPTN/UNOS data analysis.

BACKGROUND: Limited data integrating waitlist and postheart transplant (HT) mortality have evaluated outcomes of left ventricular assist device (LVAD)-bridged strategy vs no LVAD according to patient characteristics. We evaluated waitlist and post-HT mortality in LVAD-bridged vs nonbridged patients based on body mass index (BMI). METHODS: We included linked adults listed for HT in Organ Procurement and Transplant Network/United Network for Organ Sharing and patients receiving durable LVAD as bridge to HT or candidacy in Society of Thoracic Surgeons/Interagency Mechanical Circulatory Support databases (2010-2019). Using BMI at listing or LVAD implant, we categorized patients as underweight (<18.5 kg/m2), normal weight (18.5-24.99 kg/m2), overweight (25-29.99 kg/m2), and obese (≥30 kg/m2). Kaplan-Meier analysis and multivariable Cox proportional hazards models informed the effect of LVAD-bridged and nonbridged strategy by BMI on waitlist, post-HT, and overall mortality (including waitlist and post-HT mortality). RESULTS: Among 11,216 LVAD-bridged and 17,122 nonbridged candidates, bridged candidates were more frequently obese (37.3% vs 28.6%) (p < 0.001). Multivariable analysis indicated increased waitlist mortality in LVAD-bridged vs nonbridged with overweight (Hazard ratio (HR) 1.18, 95% confidence interval (CI) 1.02-1.36) or obesity (HR 1.35, 95%CI 1.17-1.56) in comparison to normal weight candidates (HR 1.02, 95%CI 0.88-1.19) (p-interaction < 0.001). Post-transplant mortality was not statistically different in LVAD-bridged vs nonbridged patients across BMI categories (p-interaction = 0.26). There was a nonsignificant graded increase in overall mortality in LVAD-bridged with overweight (HR 1.53, 95%CI 1.39-1.68) or obesity (HR 1.61, 95%CI 1.46-1.78) compared to nonbridged patients (p-interaction = 0.13). CONCLUSIONS: LVAD-bridged candidates with obesity had higher waitlist mortality compared to nonbridged candidates with obesity. Post-transplant mortality was similar in LVAD-bridged and nonbridged patients, but obesity remained associated with increased mortality in both groups. This study may aid clinicians and advanced heart failure patients with obesity in decision-making.

Hospital Mortality and Adverse Events Following Repair of Congenital Heart Defects in Developing Countries.

BACKGROUND: Mortality associated with the correction of congenital heart disease has decreased to approximately 2% in developed countries and major adverse events are uncommon. Outcomes in developing countries are less well defined. The World Database for Pediatric and Congenital Heart Surgery was utilized to compare mortality and adverse events in developed and developing countries. METHODS: A total of 16,040 primary procedures were identified over a two-year period. Centers that submitted procedures were dichotomized to low/middle income (LMI) and high income (HI) by the Gross National Income per capita categorization. Mortality was defined as any death following the primary procedure to discharge or 90 days inpatient. Multiple logistic regression models were utilized to identify independent predictors of mortality. RESULTS: Of the total number of procedures analyzed, 83% (n = 13,294) were from LMI centers. Among all centers, the mean age at operation was 2.2 years, with 36% (n = 5,743) less than six months; 85% (n = 11,307) of procedures were STAT I/II for LMI centers compared with 77% (n = 2127) for HI centers (P < .0001). Overall mortality across the cohort was 2.27%. There was a statistical difference in mortality between HI centers (0.55%) versus LMI centers (2.64%) (P < .0001). After adjustment for other risk factors, the risk of death remained significantly higher in LMI centers (odds ratio: 2.36, 95% confidence interval: 1.707-3.27). CONCLUSION: Although surgical expertise has increased across the globe, there remains a disparity with some outcomes associated with the correction of congenital heart disease between developing and developed countries. Further studies are needed to identify specific opportunities for improvement.

The World Society for Pediatric and Congenital Heart Surgery: 2021 Update of the World Database for Pediatric and Congenital Heart Surgery.

BACKGROUND: The World Database for Pediatric and Congenital Heart Surgery (WDPCHS), sponsored by the World Society for Pediatric and Congenital Heart Surgery (WSPCHS), provides complex programmatic outcomes analyses for all members of the WSPCHS. METHODS: The Data center, currently at Kirklin Institute for Research in Surgical Outcomes (KIRSO), University of Alabama, Birmingham (USA), provides biannual reports to all active members of the database. This report presents a descriptive analysis of these procedures submitted from January 1, 2017 to December 31, 2020. RESULTS: A total of 37,386 procedures were submitted with an overall mortality of 4.3%. The majority of submissions were from Asian countries. The majority of cases submitted from these countries were of Society of Thoracic Surgeons (STS)-European Association for Cardio-Thoracic Surgery (STAT) Mortality Categories I and II. CONCLUSIONS: The WSPCHS accomplished one of its missions in 2017 when the WDPCHS began accepting data from pediatric and congenital heart surgery programs across the globe. In doing so, it became one of the first organizations to create a platform for the exchange of knowledge and experience, regardless of the socioeconomic status of the particular program or country.

Generalizability of Trial Data to Real-World Practice: An Analysis of The Society of Thoracic Surgeons Intermacs Database.

BACKGROUND: Although the current wide-scale adoption of the HeartMate 3 left ventricular assist device can be attributed to favorable clinical trial outcomes, restrictive clinical trial eligibility criteria may result in lack of generalizability to real-world populations. We assessed the generalizability of left ventricular assist device clinical trial outcomes and evaluated the prognostic value of specific inclusion and exclusion criteria. METHODS: The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3 (MOMENTUM 3) eligibility criteria were applied to patients identified in The Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) who underwent HeartMate 3 implantation (n = 4610) between August 2017 and March 2020. Patients were categorized as trial-eligible or trial-ineligible and by number of ineligibility criteria. The effect of trial eligibility on mortality was estimated using Cox models. RESULTS: Indications for HeartMate 3 implant included destination therapy (n = 2827, 61%), bridge to candidacy (n = 969, 21%), and bridge to transplant (n = 702, 15%). A total of 1941 recipients (42%) were trial-ineligible, with 1245 (27%) meeting one ineligibility criterion, 470 (10%) meeting two, and 226 (5%) meeting three or more. Estimated 1-year mortality for trial-ineligible recipients was higher than for trial-eligible recipients (17% ± 1% vs 10% ± 1%, P < .001). Compared with trial-eligible patients, 1-year mortality was incrementally higher for patients meeting one ineligibility criterion (15% ± 1%), two criteria (16% ± 2%), and three or more criteria (30% ± 3%). Thrombocytopenia and elevated creatinine, bilirubin, and international normalized ratio in trial-ineligible patients were independently associated with increased mortality. CONCLUSIONS: Despite differences in mortality, both trial-eligible and trial-ineligible HeartMate 3 recipients had excellent outcomes in real-world practice, suggesting future trial eligibility criteria could be expanded.

Progression to Transplant Under the New Heart Allocation System: The Society of Thoracic Surgeons Intermacs Database.

BACKGROUND: Under the new heart allocation policy patients needing durable left ventricular assist devices receive lower priority on the transplant list. We sought to identify predictors of successful heart transplant after durable device implant as a means to inform patient care in the current era. METHODS: All patients (N = 25,164) undergoing primary durable left ventricular device implant in The Society of Thoracic Surgeons Intermacs database (2010-2019) were evaluated. Patients identified as bridge to transplant (BTT; n = 5242) or bridge to candidacy (n = 6248) were analyzed with the endpoint of transplant before (n = 10,588) and after (n = 902) the change in the heart allocation system on October 18, 2018. Multivariable hazard modeling was used to assess risk-adjusted time to event associations. RESULTS: Of 11,490 patients, 45.5% progressed to transplant (BTT, 53.0%; bridge to candidacy, 36.6%), most by 14 months after left ventricular assist device implant. Under the new allocation system progression to transplant was significantly lower at 14 months (18.6% vs 34.8%, P < .001). Factors associated with successful BTT before the allocation change included BTT status, white race, and married. Under the new allocation system BTT status (hazard ratio, 1.79; 95% confidence interval, 1.19-2.69; P < .0054) remained a positive predictor, whereas blood type O (hazard ratio, 0.43; 95% confidence interval, 0.28-0.65; P < .0001) remained a negative predictor. CONCLUSIONS: Despite having priority in the previous allocation system, less than half of BTT and bridge to candidacy patients progressed to transplant. Under the current system these numbers are further reduced. Heart teams should consider the implications of longer wait times for a durable left ventricular assist device when determining the optimal bridging strategy.

Contemporary Left Ventricular Assist Device Outcomes in an Aging Population: An STS INTERMACS Analysis.

BACKGROUND: Survival, functional outcomes, and quality of life after left ventricular assist device (LVAD) are ill-defined in elderly patients, and with new-generation devices. OBJECTIVES: This study sought to evaluate survival, functional outcomes, and quality of life after LVAD in contemporary practice. METHODS: Adults receiving durable LVADs between January 1, 2010, and March 1, 2020, were identified from the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) database. The primary outcome was adjusted survival; secondary outcomes included quality of life rated using a visual analogue scale (where 0 represents "worst health" and 100 "best health"); 6-minute walk distance; stroke; device malfunction; and rehospitalization, stratified by patient age. Median follow-up was 15 months (IQR: 6-32 months). RESULTS: The cohort comprised 68.9% (n = 16,808) patients aged <65 years, 26.3% (n = 6,418) patients aged 65-75 years, and 4.8% (n = 1,182) patients aged >75 years, who were predominantly male (n = 19,119, 78%) and on destination therapy (n = 12,425, 51%). Competing outcomes analysis demonstrated mortality (70% CIs) of 34% (33%-34%), 54% (54%-55%), and 66% (64%-68%) for patients aged <65, 65-75, and >75 years, respectively, which improved during the study in patients aged >75 years. Newer-generation devices were associated with reduced late mortality (HR: 0.35; 95% CI: 0.25-0.49). Stroke, device malfunction or thrombosis, and rehospitalizations decreased with increasing age (all P < 0.01). Median 6-minute walk distance increased from 0 feet (IQR: 0-665 feet) to 1,065 feet (IQR: 642-1,313 feet) (P < 0.001), and quality of life improved from 40 (IQR: 15-60) to 75 (IQR: 60-90) (P < 0.001) after LVAD in all age groups. CONCLUSIONS: In elderly patients, LVADs are associated with increased functional capacity, similar improvements in quality of life, and fewer complications compared with younger patients.

Stroke in pediatric ventricular assist device patients-a pedimacs registry analysis.

BACKGROUND: Cerebralvascular accidents (CVA) are common complications of pediatric ventricular assist devices (VADs). We employed the Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) to investigate rates, risk factors, and outcomes of CVA in pediatric patients supported on VAD. METHODS: Analysis of Pedimacs (September 2012-June 2019) data to determine rates of all neurologic events and specifically CVA. Risk factors were determined by a multiphase parametric hazard model. Outcomes of patients with CVA were compared with patients without CVA. RESULTS: We included 662 patients in our analysis. In total, 87 CVA events occurred in 71 patients (10.7%). The proportion of patients with CVA was highest in the paracorporeal pulsatile group (16.9%) followed by the paracorporeal continuous group (10.4%). However, the rate of CVA was lower in the paracorporeal pulsatile group compared to the paracorporeal continuous group (6.4 vs 11.1 events/100 patient months), which reflects differences in support duration. Ascites, higher patient profile groups, and implants within small volume centers were associated with the occurrence of CVA. Our analysis found that the recent era (i.e., June 2017), and intracorporeal continuous implants were protective. Mortality was higher in patients following a CVA diagnosis compared to those without a CVA diagnosis. CONCLUSIONS: CVA continues to be a problem in pediatric VAD support, though the overall percent is now <11%. Data from the most recent era are encouraging, but CVA is still significantly associated with mortality. Future efforts should focus on pre-implant and early support periods.

A prediction model for postoperative urinary retention after thoracic surgery.

Background: Urinary retention remains a frequent postoperative complication, associated with patient discomfort and delayed discharge following general thoracic surgery (GTS). We aimed to develop and prospectively validate a predictive model of postoperative urinary retention (POUR) among GTS patients. Methods: We retrospectively developed a predictive model using data from the Society of Thoracic Surgeons GTS Database at our institution. The patient study cohort included adults undergoing elective in-patient surgical procedures without a history of renal failure or Foley catheter on entry to the recovery suite (August 2013 to March 2017). Multivariable logistic regression models identified factors associated with urinary retention, and a nomogram to aid medical decision making was developed. The predictive model was validated in a cohort of GTS patients between April 2017 and November 2018 using receiver operating characteristic (ROC) analysis. Results: The predictive model was developed from 1484 GTS patients, 284 of whom (19%) experienced postoperative urinary retention within 24 hours of the operation. Risk factors for POUR included older age, male sex, higher preoperative creatinine, chronic obstructive pulmonary disease, primary diagnosis, primary procedure, and use of postoperative patient-controlled analgesia. A logistic nomogram for estimating the risk of POUR was created and validated in 646 patients, 65 of whom (10%) had urinary retention. The ROC curves of development and validation models had similar favorable c-statistics (0.77 vs 0.72; P > .05). Conclusions: Postoperative urinary retention occurs in nearly 20% of patients undergoing major GTS. Using a validated predictive model may help by targeting certain patients with prophylactic measures to prevent this complication.

The Disturbing Findings of Pediatric Firearm Injuries From the National Trauma Data Bank: 2010-2016.

BACKGROUND: Trauma is the leading cause of pediatric and adolescent morbidity and mortality. Firearm-related injuries and deaths contribute substantially to the overall disease burden. This study described the intent, location, demographics, and outcomes of a nationally representative pediatric population with firearm injuries. We hypothesized that younger patients would have a higher percentage of unintentional and self-inflicted injuries with associated higher mortality rates. MATERIALS AND METHODS: The National Trauma Data Bank, maintained by the American College of Surgeons, from 2010 to 2016 was utilized. All pediatric patients (0-19 y) with firearm injuries who had complete data were analyzed for mechanism, location, demographics, and outcomes. Basic descriptive statistics were used to compare subgroups. Multivariable logistic regression analysis was applied to investigate risk factors for firearm injury-caused mortality. RESULTS: In the study period, 46,039 pediatric patients sustained firearm injuries (median age = 17 y). Males, Blacks, ages 15-19, and the Southern region were the most common injured demographics. However, subgroup analysis showed the demographics differ for self-inflicted and unintentional firearm injuries, which had significantly higher White patients (66.6% and 47.9%, respectively; P < 0.001). Nearly 76% of injuries were related to assaults, 14% were unintentional, 5% were self-inflicted, and 5% were undetermined. The overall mortality was nearly 12%. The youngest population had higher proportion of unintentional injuries and highest mortality rate when compared with other classifications of intent (P < 0.001). CONCLUSIONS: Pediatric firearm injuries have high mortality, especially in the youngest populations. Age-tailored prevention strategies, such as strict child access prevention laws and enforced gun storage violations, may help in reducing firearm injuries and improving health outcomes.

Cardiac Surgery and Postoperative Renal Allograft Failure.

BACKGROUND: Although cardiac surgery among renal allograft recipients is relatively safe, less is known about the impact of cardiac surgery on the functioning renal allograft. This study assessed postoperative renal failure among renal transplant recipients undergoing cardiac surgery. METHODS: The study population was identified by matching medical record numbers from the United Network for Organ Sharing Kidney Transplant Database to a cardiovascular surgery database and The Society of Thoracic Surgeons Adult Cardiac Surgery Database for the authors' institution from January 1992 through August 2018. RESULTS: One hundred seventy-nine renal transplant recipients with a functioning allograft underwent cardiac surgery a mean of 6.4 ± 5.6 years after renal transplantation. Thirty (17.6%) of the 170 patients either died or had allograft failure during the first postoperative year. Receiver-operating characteristics curve analysis using Cox regression demonstrated an optimal cutoff point for preoperative serum creatinine predicting postoperative allograft loss is 1.9 mg/dL (hazard ratio 3; 95% confidence interval, 1.5 to 6.9) with a model C statistic of 0.642. CONCLUSIONS: The current study affirms findings in the literature that cardiac surgery in renal transplant recipients carries acceptable perioperative morbidity and mortality. Renal transplant recipients who underwent cardiac surgery had a constant hazard of renal allograft loss similar to that of the general transplant population. A preoperative serum creatinine value greater than 1.9 mg/dL increases the risk for long-term renal allograft loss after cardiac surgery.

Residual risk for coronary heart disease events and mortality despite intensive medical management after myocardial infarction.

BACKGROUND: High-intensity statins, beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and antiplatelet agents (ie, intensive medical management) reduce coronary heart disease (CHD) risk after myocardial infarction (MI). OBJECTIVE: The objective of the study was to determine the risk of CHD events or death despite receiving intensive medical management after MI. METHODS: We studied 16,853 United States adults with health insurance in the MarketScan and Medicare databases who underwent percutaneous coronary intervention while hospitalized for MI between January 1, 2014 and June 30, 2015 and received intensive medical management within 30 days after hospital discharge. MI, CHD, and all-cause mortality rates from 30 days after hospital discharge through December 31, 2015 were compared with 67,412 individuals in each of three groups: (1) the general MarketScan and Medicare populations, (2) with diabetes, and (3) with a CHD history. RESULTS: Among beneficiaries intensively medically managed after their MI, recurrent MI, CHD events, and all-cause mortality rates were 47.1, 72.0, and 57.5 per 1000 person-years, respectively. The multivariable-adjusted hazard ratio (95% CI) comparing intensively medically managed beneficiaries after MI to the general population, those with diabetes, and those with a history of CHD were 8.54 (7.52-9.70), 7.40 (6.61-8.28), and 5.45 (4.92-6.05), respectively, for recurrent MI; 7.82 (7.07-8.64), 6.27 (5.74-6.86), and 4.45 (4.10-4.82), respectively, for CHD events; and 1.15 (1.05-1.25), 1.05 (0.97-1.14), and 1.06 (0.97-1.15), respectively, for all-cause mortality. CONCLUSION: Substantial residual risk for MI and CHD events remains despite intensive medical management after MI.

Surgical Management of Heterotaxy Syndrome: Current Challenges and Opportunities.

INTRODUCTION: Heterotaxy syndrome presents a unique challenge in surgical management, even in the current era. We hypothesized that certain anatomic subsets merit novel strategies. METHODS: We analyzed morphologic details, surgeries, comorbidities, subsequent admissions, and survival using Kaplan-Meier methods and multivariable risk models from a single-institution experience of 103 consecutive patients with heterotaxy who underwent cardiac surgery between January 1, 1990, and May 31, 2016. RESULTS: Of the 103 patients (50 males and 53 females), 31 had left atrial isomerism, 64 had right atrial isomerism (RAI), and 8 patients' isomerism was indeterminate (IND), with first cardiac operation at a mean 1.0 year (standard deviation ±3.0 years) of age. Kaplan-Meier overall survival estimate was 83.1% at six months, 77.8% at one year, 65.9% at five years, and 52.1% at ten years. Survival was particularly low among RAI following repair of total anomalous pulmonary venous connection (TAPVC) at first operation, with one- and five-year survival of 57% and 46%, respectively. By multivariable analysis, the only risk factor for death during the early phase (hazard model) was repair of TAPVC at the first cardiac operation (hazard ratio [HR]: 4.4, P = .01), and risk factors during the longer term constant phase were atrioventricular valve (AVV) regurgitation (HR: 4.2, P < .01), male gender (HR: 3.7, P < .01), and two-ventricle repair (HR: 3.0, P = .02). Patients with heterotaxy undergoing the Fontan procedure had excellent subsequent survival (85% at ten years). CONCLUSIONS: This analysis of over 100 patients with heterotaxy identified TAPVC requiring initial repair as the major risk factor for early death and important AVV regurgitation as the major risk factor in the longer term. Survival with RAI and early repair of TAPVC were poor, with one-year mortality exceeding 40%. Patients with single ventricle completing the Fontan operation enjoyed outstanding ten-year survival (85%). Initial management of RAI requiring early repair of TAPVC remains challenging. For this high-risk subset, alternative strategies such as early referral for cardiac transplantation evaluation warrant consideration.

Prevalence of Activity Limitations and Association with Multimorbidity Among US Adults 50 to 64 Years Old.

BACKGROUND: Functional limitations may be more common in middle-aged adults than previously recognized. However, there are few published data on the prevalence of activity limitations, and their association with multimorbidity, among adults 50 to 64 years old. OBJECTIVE: To describe the prevalence of activity limitations and the association with multimorbidity in middle-aged adults. DESIGN: Cross-sectional analysis of US population-based National Health and Nutrition Examination Survey (NHANES) 2011-2016. PARTICIPANTS: The total number of community-dwelling NHANES participants aged 50-64 years old is 4217. MAIN MEASURES: Chronic conditions included hypertension, high cholesterol, diabetes mellitus, obesity, chronic kidney disease, cancer, stroke, coronary heart disease, heart failure, chronic obstructive pulmonary disease/asthma, arthritis, and depression. Activity limitations were defined as any difficulty within each of four International Classification of Functioning (ICF) domains: functional limitations (kneeling, carrying, standing, sitting, reaching, grasping, pulling), mobility (walking » mile, climbing 10 steps), basic activities of daily living (BADLs; walking, transferring, eating, dressing), and instrumental activities of daily living (IADLs; finances, chores, cooking). We calculated prevalence ratios for activity limitations using generalized estimating equations. KEY RESULTS: The prevalence of functional limitations, mobility limitations, BADL difficulty, and IADL difficulty was 34%, 11%, 15%, and 17%, respectively. Seventy-two percent of participants had two or more chronic conditions; 23% had two, 18% had three, 15% had four, and 16% had five or more. Multivariable adjusted prevalence ratios (95% CI) for functional limitations among those with 2, 3, 4, and 5 or more chronic conditions, compared with 0-1 conditions, were 1.94 (1.43-2.63), 2.50 (1.93-3.23), 3.26 (2.48-4.27), and 4.54 (3.48-5.93), respectively (p trend < 0.001). Larger prevalence ratios at a higher number of chronic conditions were present for mobility limitations, BADL difficulty, and IADL difficulty. CONCLUSIONS: Problems with function are not limited to older adults and multimorbidity may be helpful for identifying middle-aged adults with a high prevalence of activity limitations.

Sex differences in masked hypertension: the Coronary Artery Risk Development in Young Adults study.

OBJECTIVE: To evaluate the association of sex with masked hypertension, defined by out-of-clinic hypertension based on ambulatory blood pressure monitoring (ABPM) among adults without hypertension based on blood pressure (BP) measured in the clinic, after adjusting for potential confounders. METHODS: We evaluated sex differences in the prevalence of masked hypertension and the difference between awake, or alternatively 24-h, ambulatory BP and clinic BP using multivariable adjusted models among 658 participants who underwent 24-h ABPM and had clinic SBP/DBP less than 140/90 mmHg during the Year 30 Exam of the Coronary Artery Risk Development in Young Adults study. RESULTS: The mean age ±â€Šstandard deviation (SD) of the participants was 54.8 ±â€Š3.7 years, 58.4% were women, and 58.2% were black. The prevalence of any masked hypertension was 37.5% among women and 60.6% among men. In a model including adjustment for demographics, cardiovascular risk factors, antihypertensive medication, and clinic BP, the prevalence ratios (95% confidence intervals) comparing men versus women were 1.39 (1.18-1.63) for any masked hypertension, and 1.60 (1.28-1.99), 1.71 (1.36-2.15), and 1.40 (1.13-1.73) for masked awake, 24-h and asleep hypertension, respectively. In a fully adjusted model, the differences between mean awake ambulatory BP and clinic BP were 2.75 [standard error (SE) 0.92] mmHg higher for SBP and 3.61 (SE 0.58) mmHg higher for DBP among men compared with women. CONCLUSION: The prevalence of masked hypertension on ABPM was high in both men and women. Male sex was an independent predictor of masked hypertension.

Race and sex differences in asleep blood pressure: The Coronary Artery Risk Development in Young Adults (CARDIA) study.

Nocturnal hypertension and non-dipping blood pressure are each associated with increased risk of cardiovascular disease. We determined differences in nocturnal hypertension and non-dipping systolic/diastolic blood pressure among black and white men and women who underwent 24-hour ambulatory blood pressure monitoring at the Coronary Artery Risk Development in Young Adults study Year 30 Exam in 2015-2016. Asleep and awake periods were determined from actigraphy complemented by sleep diaries. Nocturnal hypertension was defined as mean asleep systolic/diastolic blood pressure ≥ 120/70 mm Hg. Non-dipping systolic and diastolic blood pressure, separately, were defined as a decline in awake-to-asleep blood pressure < 10%. Among 767 participants, the prevalence of nocturnal hypertension was 18.4% and 44.4% in white and black women, respectively, and 36.4% and 59.9% in white and black men, respectively. After multivariable adjustment and compared with white women, the prevalence ratio (95% confidence interval) for nocturnal hypertension was 1.65 (1.18-2.32) for black women, 1.63 (1.14-2.33) for white men, and 2.01 (1.43-2.82) for black men. The prevalence of non-dipping systolic blood pressure was 21.5% and 41.0% in white and black women, respectively, and 20.2% and 37.9% in white and black men, respectively. Compared with white women, the multivariable-adjusted prevalence ratio (95% confidence interval) for non-dipping systolic blood pressure was 1.66 (1.18-2.32), 0.91 (0.58-1.42) and 1.66 (1.15-2.39) among black women, white men, and black men, respectively. Non-dipping diastolic blood pressure did not differ by race-sex groups following multivariable adjustment. In conclusion, black women and men have a high prevalence of nocturnal hypertension and non-dipping systolic blood pressure.

Racial Differences in Maintaining Optimal Health Behaviors Into Middle Age.

INTRODUCTION: Earlier development of cardiovascular disease risk factors in blacks versus whites may result from differences in maintaining health behaviors. Age-specific racial differences in maintaining health behaviors from ages 18 to 50 years were determined. METHODS: In 1985-1986, the population-based Coronary Artery Risk Development in Young Adults study enrolled 5,115 participants aged 18-30 years. In 2017, a total of 2,485 blacks and 2,407 whites with one or more optimal health behaviors at baseline who attended one or more of seven follow-up exams over 25 years (i.e., through 2010-2011) were analyzed. The primary outcome, maintaining four or more optimal health behaviors, included BMI <25; never smoking; ≥150 minutes/week of moderate to vigorous physical activity; no/moderate alcohol intake (women/men: zero to seven/zero to 14 drinks per week); and Dietary Approaches to Stop Hypertension diet adherence score ≥15 (i.e., baseline highest quartile). Hazard ratios comparing blacks with whites for maintaining optimal health behaviors were calculated among participants with each optimal behavior at baseline. RESULTS: From ages 18 to 50 years, 2.6% of blacks and 9.2% of whites maintained four or more optimal health behaviors (for optimal BMI: 16.0% and 30.1%, smoking status: 74.6% and 78.4%, physical activity: 17.7% and 21.4%, alcohol intake: 68.4% and 64.6%, diet adherence: 3.9% and 10.3%, respectively). The multivariable adjusted hazard ratio comparing blacks with whites was 0.63 (95% CI=0.56, 0.72) for maintaining four or more optimal health behaviors (for optimal BMI: 0.82 [95% CI=0.66, 1.01], smoking status: 0.57 [95% CI=0.52, 0.62], physical activity: 0.83 [95% CI=0.75, 0.91], alcohol intake: 1.19 [95% CI=1.03, 1.37], diet adherence: 0.71 [95% CI=0.61, 0.82]). CONCLUSIONS: Fewer blacks than whites maintained four or more optimal health behaviors until age 50 years, but maintenance was low among both races.