Application of multiple linear regression and machine learning algorithms to elucidate the association of poor glycemic control and hyperhomocysteinemia with microalbuminuria

Microalbuminuria is an early biomarker of general vascular dysfunction and a predictor of risk for cardiovascular and renal diseases. It is also considered as a marker of insulin resistance in both diabetic and non-diabetic patients. The rationale of this study was to elucidate threshold values of fasting blood glucose (FBS) and glycosylated hemoglobin (HbA1c) that are associated with microalbuminuria. In the parallel association of microalbuminuria with hyperhomocysteinemia was investigated. Machine learning algorithm and multiple linear regression were applied to study the association of poor glycemic control on microalbuminuria and hyperhomocysteinemia. In non-diabetic subjects with FBS <102 mg/dL and HbA1c <6.3%; and in diabetic subjects with good glycemic control (FBS: 102-118 mg/dL; HbA1c: 6.3-7.0%), urinary microalbumin levels were <40µg/mg creatinine. Poor glycemic control (FBS >172 mg/dL and HbA1c >9.0%) was associated with microalbumin >40µg/mg creatinine. Age, gender, HbA1c and FBS were shown to explain variability in urinary microalbumin to the extent of 54.4% as shown by multiple linear regression model. Analysis of variance (ANOVA) revealed higher levels of FBS (F: 39.77, P <0.0001), HbA1c (F: 64.31, P <0.0001) and total plasma homocysteine (F: 3.69, P =0.04) in microalbuminuria and clinical microalbuminuria groups when compared to subjects with normal microalbumin levels. Diabetic patients with poor glycemic index had a more B12 deficiency. Poor glycemic index and hyperhomocysteinemia were associated with clinical microalbuminuria

Performance of First Pacemaker to Use Smart Device App for Remote Monitoring

BACKGROUND: High adherence to remote monitoring (RM) in pacemaker (PM) patients improves outcomes; however, adherence remains suboptimal. Bluetooth low-energy (BLE) technology in newer-generation PMs enables communication directly with patient-owned smart devices using an app without a bedside console. OBJECTIVE: To evaluate the success rate of scheduled RM transmissions using the app compared to other RM methods. METHODS: The BlueSync Field Evaluation was a prospective, international cohort evaluation, measuring the success rate of scheduled RM transmissions using a BLE PM or cardiac resynchronization therapy PM coupled with the MyCareLink Heart app. App transmission success was compared to 3 historical “control” groups from the Medtronic de-identified CareLink database: (1) PM patients with manual communication using a wand with a bedside console (PM manual transmission), (2) PM patients with wireless automatic communication with the bedside console (PM wireless); (3) defibrillator patients with similar automatic communication (defibrillator wireless). RESULTS: Among 245 patients enrolled (age 64.8±15.6 years, 58.4% men), 953 transmissions were scheduled through 12 months, of which 902 (94.6%) were successfully completed. In comparison, transmission success rates were 56.3% for PM manual transmission patients, 77.0% for PM wireless patients, and 87.1% for defibrillator wireless patients. Transmission success with the app was superior across matched cohorts based on age, sex, and device type (single vs dual vs triple chamber). CONCLUSION: The success rate of scheduled RM transmissions was higher among patients using the smart device app compared to patients using traditional RM using bedside consoles. This novel technology may improve patient engagement and adherence to RM

Application of multiple linear regression and machine learning algorithms to elucidate the association of poor glycemic control and hyperhomocysteinemia with microalbuminuria

150-154Microalbuminuria is an early biomarker of general vascular dysfunction and a predictor of risk for cardiovascular and renal diseases. It is also considered as a marker of insulin resistance in both diabetic and non-diabetic patients. The rationale of this study was to elucidate threshold values of fasting blood glucose (FBS) and glycosylated hemoglobin (HbA1c) that are associated with microalbuminuria. In the parallel association of microalbuminuria with hyperhomocysteinemia was investigated. Machine learning algorithm and multiple linear regression were applied to study the association of poor glycemic control on microalbuminuria and hyperhomocysteinemia. In non-diabetic subjects with FBS 172 mg/dL and HbA1c >9.0%) was associated with microalbumin >40µg/mg creatinine. Age, gender, HbA1c and FBS were shown to explain variability in urinary microalbumin to the extent of 54.4% as shown by multiple linear regression model. Analysis of variance (ANOVA) revealed higher levels of FBS (F: 39.77, P P P =0.04) in microalbuminuria and clinical microalbuminuria groups when compared to subjects with normal microalbumin levels. Diabetic patients with poor glycemic index had a more B12 deficiency. Poor glycemic index and hyperhomocysteinemia were associated with clinical microalbuminuria

Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has shown favorable outcomes in large registries with broad inclusion criteria. The cohorts reported had less heart disease and fewer comorbidities than standard ICD populations. Objective: The purpose of this study is to characterize acute performance for primary prevention patients with a left ventricular ejection fraction (LVEF) ≤35% (primary prevention ≤35%). Methods: Primary prevention ≤35% patients with no prior documented sustained ventricular tachycardia (VT), pacing indication, end-stage heart failure, or advanced renal failure were prospectively enrolled. Analyses included descriptive statistics, Kaplan-Meier time to event, and multivariable linear and logistic regression. Results: In 1112 of 1116 patients, an S-ICD was successfully implanted (99.6%). Predictors for longer procedure time included 3-incision technique, higher body mass index (BMI), performing defibrillation testing (DFT), imaging, younger age, black race, and European vs North American centers. Patients undergoing DFT (82%) were successfully converted (99.2%; 93.5% converting at ≤65 J). Higher BMI was predictive of failing DFT at ≤65 J. The rate of 30-day freedom from complications was 95.8%. Most complications involved postoperative healing (45%) or interventions after DFT or impedance check (19%). Conclusion: The procedural outcome data of UNTOUCHED reinforce that S-ICD therapy has low perioperative complication rates and high conversion efficacy of induced ventricular fibrillation, even in a higher-risk cohort with low LVEF and more comorbidities than previous S-ICD studies. Higher BMI warrants more careful attention to implant technique

Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial

BackgroundThe subcutaneous (S) implantable cardioverter-defibrillator (ICD) is safe and effective for sudden cardiac death prevention. However, patients in previous S-ICD studies had fewer comorbidities, had less left ventricular dysfunction, and received more inappropriate shocks (IAS) than in typical transvenous ICD trials. The UNTOUCHED trial (Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction) was designed to evaluate the IAS rate in a more typical, contemporary ICD patient population implanted with the S-ICD using standardized programming and enhanced discrimination algorithms.MethodsPrimary prevention patients with left ventricular ejection fraction ≤35% and no pacing indications were included. Generation 2 or 3 S-ICD devices were implanted and programmed with rate-based therapy delivery for rates ≥250 beats per minute and morphology discrimination for rates ≥200 and ResultsS-ICD implant was attempted in 1116 patients, and 1111 patients were included in postimplant follow-up analysis. The cohort had a mean age of 55.8±12.4 years, 25.6% were women, 23.4% were Black, 53.5% had ischemic heart disease, 87.7% had symptomatic heart failure, and the mean left ventricular ejection fraction was 26.4±5.8%. Eighteen-month freedom from IAS was 95.9% (lower confidence limit, 94.8%). Predictors of reduced incidence of IAS were implanting the most recent generation of device, using the 3-incision technique, no history of atrial fibrillation, and ischemic cause. The 18-month all-cause shock-free rate was 90.6% (lower confidence limit, 89.0%), meeting the prespecified performance goal of 85.8%. Conversion success rate for appropriate, discrete episodes was 98.4%. Complication-free rate at 18 months was 92.7%.ConclusionsThis study demonstrates high efficacy and safety with contemporary S-ICD devices and programming despite the relatively high incidence of comorbidities in comparison with earlier S-ICD trials. The inappropriate shock rate (3.1% at 1 year) is the lowest reported for the S-ICD and lower than many transvenous ICD studies using contemporary programming to reduce IAS. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02433379.</div