Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial.

BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.

Pre- and Post-transcatheter Aortic Valve Replacement (TAVR) Serum Mean Platelet Volume Levels and All-Cause Mortality.

BACKGROUND: Among the most frequent complications following transcatheter aortic valve replacement (TAVR) is hemostasis imbalance that presents either as thromboembolic or bleeding. Deviations in platelet count (PC) and mean platelet volume (MPV) are markers of hemostasis imbalance. OBJECTIVES: To determine the predictive value of pre- and post-procedural PC and MPV fL 1-year all-cause mortality in patients who underwent TAVR. METHODS: In this population-based study, we included 236 TAVR patients treated at the Tzafon Medical Center between 1 June 2015 and 31 August 2018. Routine blood samples for serum PC levels and MPV fL were taken just before the TAVR and 24-hour post-TAVR. We used backward regression models to evaluate the predictive value of PC and MPV in all-cause mortality in TAVR patients. RESULTS: In this study cohort, MPV levels 24-hour post-TAVR that were greater than the cohort median of 9 fL (interquartile range 8.5-9.8) were the strongest predictor of 1-year mortality (hazard ratio 1.343, 95% confidence interval 1.059-1.703, P-value 0.015). A statistically significant relationship was seen in the unadjusted regression model as well as after the adjustment for clinical variables. CONCLUSIONS: Serum MPV levels fL 24-hour post-procedure were found to be meaningful markers in predicting 1-year all-cause mortality in patients after TAVR.

Safety of catheter ablation for atrial fibrillation in patients with mechanical prosthetic valves.

BACKGROUND: Catheter ablation (CA) for atrial fibrillation (AF) is increasingly utilized in recent years, with promising results. We aimed to investigate the nationwide trends in utilization and procedural complications of CA for AF in patients with mechanical prosthetic valves (MPVs). METHODS AND RESULTS: We drew data from the US National Inpatient Sample (NIS) database to identify cases of AF ablations in patients with MPVs, between 2003 and 2015. Sociodemographic and clinical data were collected, and incidence of procedural complications, mortality, and length of stay were analyzed. We compared the outcomes to a propensity-matched cohort of patients without MPVs. The study included a weighted total of 1898 CA for AF cases in patients with MPVs. The median age of the study population was 67 (61-75) years and 53% were males. Despite the increasing age and significant uptrend in the prevalence of individual comorbidities and Deyo-Charlson Comorbidity Index (CCI) over the years, the risk of peri-procedural complications and mortality in the study group did not change between the early (2003-2008) and late (2009-2015) study years. The peri-procedural complication rate (8.4% vs. 10.4%, p = .33) and in-hospital mortality (0.2% vs. 0.2%, p = .9) did not differ significantly between patients with MPVs and 1901 matched patients without MPVs. Length of stay was higher among patients with prior MPVs compared to the controls (4.0 ± 0.2 vs. 3.3 ± 0.2 days, p = .011). CONCLUSION: This nationwide analysis shows that AF ablation in patients with mechanical valve prothesis bares a similar risk of periprocedural complications and mortality as in patients without prosthetic valves.

The Impact of Obesity on Sudden Cardiac Death Risk.

PURPOSE OF REVIEW: We aimed to describe the epidemiology of sudden cardiac death (SCD) in the obese, elaborating on the potential pathophysiological mechanisms linking obesity, SCD, and the outcomes in SCD survivors, as well as looking into the intriguing "obesity paradox" in these patients. RECENT FINDINGS: Several studies show increased mortality in patients with BMI > 30 kg/m2 admitted to the hospital following SCD. At the same time, other studies have implied that the "obesity paradox," described in various cardiovascular conditions, applies to patients admitted after SCD, showing lower mortality in the obese compared to normal weight and underweight patients. We found a significant body of evidence to support that while obesity increases the risk for SCD, the outcomes of obese patients post SCD are better. These findings should not be interpreted as supporting weight gain, as it is always better to prevent the "disaster" from happening than to improve your chances of surviving it. Obesity is shown to be significantly associated with increased risk for SCD; however, there is a growing body of evidence, supporting the "obesity paradox" in the survival of SCD victims. Prospectively, well-designed studies are needed to confirm these findings.

Ventricular arrhythmia ablation in the presence of mechanical valve utilization and complications of catheter ablation for ventricular arrhythmia in patients with mechanical prosthetic valves.

BACKGROUND: Catheter ablation (CA) for ventricular arrhythmias (VAs) is increasingly utilized in recent years. We aimed to investigate the nationwide trends in utilization and procedural complications of CA for VAs in patients with mechanical valve (MV) prosthesis. METHODS: We drew data from the US National Inpatient Sample database to identify cases of VA ablations, including premature ventricular contraction and ventricular tachycardia, in patients with MVs, between 2003 and 2015. Sociodemographic and clinical data were collected and the incidence of catheter ablation complications, mortality, and length of stay were analyzed. We compared the outcomes to a propensity-matched cohort of patients without prior valve surgery. RESULTS: The study population included a weighted total of 647 CA cases in patients with prior MVs. The annual number of ablations almost doubled, from 34 ablations on average during the "early years" (2003-2008) to 64 on average during the "late years" (2009-2015) of the study (p = .001). Length of stay at the hospital did not differ significantly between patients with MVs and 649 matched patients without prior MVs (5.4 ± 0.4, 4.7 ± 0.3 days, respectively, p = .12). The data revealed a trend toward a higher incidence of complications (12.6% vs. 7.5% respectively, p = .14) and mortality (3.7% vs. 0.7%, respectively, p = .087) among patients with MVs compared to the matched control group, not reaching statistical significance. CONCLUSION: The data show increased utilization of VA ablations in patients with MVs and a trend toward a higher incidence of in-hospital mortality and complications compared to the propensity-matched control group without MVs.

Left atrial minimal volume: association with diastolic dysfunction and heart failure in patients in sinus rhythm or atrial fibrillation with preserved ejection fraction.

BACKGROUND: Evidence of diastolic dysfunction (DD) required for the diagnosis of heart failure with preserved ejection fraction (HFpEF) is elusive in atrial fibrillation (AF). Left ventricular (LV) and left atrial (LA) speckle-tracking echocardiography (STE) may provide rhythm independent indications of DD. We aimed to find common LV/LA myocardial mechanics parameters to demonstrate DD, using STE in patients with AF. METHODS: 176 echocardiographic assessments of patients were studied retrospectively by STE. 109 patients with history of AF were divided in three groups: sinus with normal diastolic function (n = 32, ND), sinus with DD (n = 35, DD) and patients with AF during echocardiography (n = 42). These assessments were compared to 67 normal controls. Demographic, clinical, echocardiographic and myocardial mechanic characteristics were obtained. RESULTS: The patients with DD in sinus rhythm and patients with AF were similar in age, mostly women, and had cardiovascular risk factors as well as higher dyspnea prevalence compared to either controls or patients with ND. In the AF group, LV ejection fraction (LVEF) (p = 0.008), global longitudinal strain and LA emptying were lower (p < 0.001), whereas LA volumes were larger (p < 0.001) compared to the other groups. In a multivariable analysis of patients in sinus rhythm, LA minimal volume indexed to body surface area (Vmin-I) was found to be the single significant factor associated with DD (AUC 83%). In all study patients, Vmin-I correlated with dyspnea (AUC 80%) and pulmonary hypertension (AUC 90%). CONCLUSIONS: Vmin-I may be used to identify DD and assist in the diagnosis of HFpEF in patients with AF.

Novel automated point collection software facilitates rapid, high-density electroanatomical mapping with multiple catheter types.

INTRODUCTION: Manual, point-by-point electroanatomical mapping requires the operator to directly evaluate each point during map construction. Consequently, point collection can be a slow process. An automated 3D mapping system was developed with the goal of improving key mapping metrics, including map completion time and point density. METHODS: Automated 3D mapping software that includes morphology and cycle length discrimination functions for surface and intracardiac electrograms was developed. In five swine, electroanatomical maps (EAMs) of all four cardiac chambers were generated in sinus rhythm. Four catheters were used: two different four-pole ablation catheters, a 20-pole circular catheter, and a 64-pole basket catheter. Automated and manual 3D mapping were compared for 12 different catheter-chamber combinations (paired sets of 10 maps for most combinations, for a total of 156 maps). RESULTS: Automated 3D mapping produced more than twofold increase in the number of points per map, as compared with manual 3D mapping (P ≤0.007 for all catheter-chamber combinations tested). Automated 3D mapping also reduced map completion time by an average of 29% (P < 0.05 for all comparisons). The amount of manual editing of the maps acquired with automated 3D mapping was minimal. CONCLUSION: Automated 3D mapping with the open-platform mapping software described in this study is significantly faster than manual, point-by-point 3D mapping. This resulted in shorter mapping time and higher point density. The morphology discrimination functions effectively excluded ectopic beats during mapping in sinus rhythm and allowed for rapid mapping of intermittent ventricular ectopic beats.

Safety and efficacy of delivering high-power short-duration radiofrequency ablation lesions utilizing a novel temperature sensing technology.

Aims: Delivery of high-power short-duration radiofrequency (RF) ablation lesions is not commonly used, in part because conventional thermocouple (TC) technology underestimates tissue temperature, increasing the risk of steam pop, and thrombus formation. We aimed to test whether utilization of an ablation catheter equipped with a highly accurate novel TC technology could facilitate safe and effective delivery of high-power RF lesions. Methods and results: Adult male Yorkshire swine were used for the study. High-power short-duration ablations (10-s total; 90 W for 4 s followed by 50 W for 6 s) were delivered using an irrigated force sensing catheter, equipped with six miniature TC sensors embedded in the tip electrode shell. Power modulation was automatically performed when the temperature reached 65°C. Ablation parameters were recorded and histopathological analysis was performed to assess lesion formation. One hundred and fourteen RF applications, delivered using the study ablation protocol in the ventricles of eight swine [53 in the right ventricle (RV), 61 in the left ventricle (LV)], were analysed. Average power delivered was 55.4 ± 5.3 W and none of the ablations resulted in a steam pop. Fourteen out of the 114 (12.3%) lesions were transmural. The mean lesion depth was 3.9 ± 1.1 mm for the 100 non-transmural lesions. Similar ablation parameters resulted in bigger impedance drop (11.6 Ω vs. 9.1 Ω, P = 0.009) and deeper lesions in the LV compared with the RV (4.3 ± 1.2 mm vs. 3.3 ± 0.8 mm, P < 0.001). Conclusion: Delivery of high-power short-duration RF energy applications, facilitated by a novel ablation catheter system equipped with advanced TC technology, is feasible, safe, and results in the formation of effective ablation lesions.

Utilization and in-hospital complications of cardiac resynchronization therapy: trends in the United States from 2003 to 2013.

Aims: Cardiac resynchronization therapy (CRT) device implantation has been shown to reduce morbidity and mortality in selected patients with heart failure. We sought to investigate the utilization and in-hospital complications of cardiac resynchronization therapy defibrillator (CRT-D) and pacemaker (CRT-P) implantations in the United States from 2003 to 2013. Methods and results: Patients receiving CRT-D or CRT-P were identified in the National Inpatient Sample database (NIS), using the International Classification of Diseases-Ninth Revision-Clinical Modification procedure codes. Annual implantation rates, patient demographics, co-morbidities, in-hospital complications, and length of stay were analysed. From 2003 to 2013, an estimated total of 439 010 (95% CI: 406 723-471 296) inpatient CRT implantations were performed in the U.S. The median age of patients was 72 and 71% were male. Overall, 6.1% had at least one complication. During the study period, comorbidity index and overall complication rate increased (P = 0.002 and P = 0.01, respectively). Mortality and length of stay showed no significant trend. Predictors of complications included: age 65 and older, female sex (OR: 1.19; 95% CI: 1.12-1.27), Deyo-Charlson Comorbidity Index, and elective admission (OR: 0.61; 95% CI: 0.57-0.66). Conclusion: From 2003 to 2013, the severity of comorbid conditions increased and a rising trend was observed in the rate of periprocedural complications among patients undergoing CRT in the United States. In-hospital mortality and length of stay showed no uniform trend.

Single-scan rest/stress imaging: validation in a porcine model with 18F-Flurpiridaz.

PURPOSE: 18F-labeled myocardial flow agents are becoming available for clinical application but the ∼2 hour half-life of 18F complicates their clinical application for rest-stress measurements. The goal of this work is to evaluate in a pig model a single-scan method which provides quantitative rest-stress blood flow in less than 15 minutes. METHODS: Single-scan rest-stress measurements were made using 18F-Flurpiridaz. Nine scans were performed in healthy pigs and seven scans were performed in injured pigs. A two-injection, single-scan protocol was used in which an adenosine infusion was started 4 minutes after the first injection of 18F-Flurpiridaz and followed either 3 or 6 minutes later by a second radiotracer injection. In two pigs, microsphere flow measurements were made at rest and during stress. Dynamic images were reoriented into the short axis view, and regions of interest (ROIs) for the 17 myocardial segments were defined in bull's eye fashion. PET data were fitted with MGH2, a kinetic model with time varying kinetic parameters, in which blood flow changes abruptly with the introduction of adenosine. Rest and stress myocardial blood flow (MBF) were estimated simultaneously. RESULTS: The first 12-14 minutes of rest-stress PET data were fitted in detail by the MGH2 model, yielding MBF measurement with a mean precision of 0.035 ml/min/cc. Mean myocardial blood flow across pigs was 0.61 ± 0.11 mL/min/cc at rest and 1.06 ± 0.19 mL/min/cc at stress in healthy pigs and 0.36 ± 0.20 mL/min/cc at rest and 0.62 ± 0.24 mL/min/cc at stress in the ischemic area. Good agreement was obtained with microsphere flow measurement (slope = 1.061 ± 0.017, intercept = 0.051 ± 0.017, mean difference 0.096 ± 0.18 ml/min/cc). CONCLUSION: Accurate rest and stress blood flow estimation can be obtained in less than 15 min of PET acquisition. The method is practical and easy to implement suggesting the possibility of clinical translation.

A Novel Annotation Technique During Mapping to Facilitate the Termination of Atrial Tachycardia Following Ablation for Atrial Fibrillation.

INTRODUCTION: The treatment of atrial tachycardia (AT) occurring after ablation for atrial fibrillation (AF) is challenging. The most common ablation strategy relies on entrainment, and electroanatomic activation mapping (EAM) using a conventional window of interest (WOI), centered on the easily detectable atrial signal on the coronary sinus catheter. We describe a novel EAM annotation technique that uses a WOI starting 40 milliseconds prior to the P wave in order to detect the reentrant AT exit site. This WOI timing is based on the similarity between scar-related reentrant AT and scar-related ventricular tachycardia. METHODS: Patients with AT after prior ablation for AF were included. The EAM of the AT was performed using the novel mapping annotation technique. The ablation was considered successful if the AT terminated during ablation at the site identified by this strategy. RESULTS: Twenty-eight patients with 36 ATs were included. The ATs were classified as follows: mitral annulus (13/36), roof (11/36), anterior/posterior/lateral left atrial wall (10/36), and RA (2/36). A complete EAM using the novel annotation technique was achieved in 34 of 36 AT's, encompassing 94 ± 6.5% of the cycle length. Low amplitude pre-P fractionated electrograms were found in 34 of 36 (94%) ATs and these occurred at a mean distance of 1.8 ± 1.2 mm from the "early-meets-late" line. Ablation at these areas resulted in termination of 34 of 36 ATs (94%). CONCLUSION: The novel EAM annotation allows the accurate detection of the critical isthmus of post-AF ablation AT. Ablation of these isthmuses results in termination of the AT in the vast majority of patients.

Do implantable cardioverter defibrillators contribute to new depression or anxiety symptoms? A retrospective study.

OBJECTIVE: In this retrospective cross-sectional study, we evaluated the existence of psychiatric symptoms which appeared after implantation of an implantable cardioverter defibrillator (ICD). METHODS: Patients with ICDs were diagnosed using the Mini International Neuropsychiatric Interview (MINI) and were excluded if they had any psychiatric diagnosis prior to ICD implantation. Depression and anxiety were evaluated using the HAM-D and HAM-A rating scales and their attitude towards the ICD using a visual analog scale (VAS). Ninety five ICD patients with mean age of 66 years (±11.5) were recruited, 80 (84%) were men. RESULTS: Four (4%) patients were diagnosed with new-onset MDD and one patient (1%) with anxiety. Twenty seven (28%) were found to have significant depressive symptoms (HAM-D >8), without MDD diagnosis; half of them attributing these symptoms to the device. Seven (8%) patients experienced phantom shocks and had relatively higher depressive scores (HAM-D 10.3 vs. 5.8; F = 3.696; p = 0.058). The MDD rates in our study were rather consistent with those reported for cardiac patients. CONCLUSIONS: We suggest that ICD contributed little, if any, additional depressive or anxiety symptoms after implantation. We found that the overall attitude towards the device was positive and that shocks and phantom shocks were related to depressive symptoms.

Predictors and outcomes of "super-response" to cardiac resynchronization therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) has been shown to improve heart failure (HF) symptoms and survival. We hypothesized that a greater improvement in left-ventricular ejection fraction (LVEF) after CRT is associated with greater survival benefit. METHODS AND RESULTS: In 693 patients across 2 international centers, the improvement in LVEF after CRT was determined. Patients were grouped as non-/modest-, moderate-, or super-responders to CRT, defined as an absolute change in LVEF of ≤5%, 6-15%, and >15%, respectively. Changes in New York Heart Association (NYHA) functional class and left ventricular end-diastolic dimension (LVEDD) were assessed for each group. There were 395 non-/modest-, 186 moderate-, and 112 super-responders. Super-responders were more likely to be female and to have nonischemic cardiomyopathy, lower creatinine, and lower pulmonary artery systolic pressure than non-/modest- and moderate-responders. Super-responders were also more likely to have lower LVEF than non-/modest-responders. There was no difference in NYHA functional class, mitral regurgitation grade, or tricuspid regurgitation grade between groups. Improvement in NYHA functional class (-0.9 ± 0.9 vs -0.4 ± 0.8 [P < .001] and -0.6 ± 0.8 [P = .02]) and LVEDD (-8.7 ± 9.9 mm vs -0.5 ± 5.0 and -2.4 ± 5.8 mm [P < .001 for both]) was greatest in super-responders. Kaplan-Meier survival analysis revealed that super-responders achieved better survival compared with non-/modest- (P < .001) and moderate-responders (P = .049). CONCLUSIONS: Improvement in HF symptoms and survival after CRT is proportionate to the degree of improvement in LV systolic function. Super-response is more likely in women, those with nonischemic substrate, and those with lower pulmonary artery systolic pressure.

Sex difference and outcome trends following surgical aortic valve replacement from the National Inpatient Sample (NIS) Database.

BACKGROUND: Based on worldwide registries, approximately 50% of patients who underwent aortic valve replacement (AVR) via surgical aortic valve replacement are females. Although AVR procedures have improved greatly in recent years, differences in outcome including mortality between sexes remain. We aimed to investigate the trends in SAVR outcomes in females versus males. METHODS: Using the 2011-2017 National Inpatient Sample (NIS) database, we identified hospitalizations for patients with diagnosis of aortic stenosis during which SAVR was performed. Patients' sociodemographic and clinical characteristics, procedure complications, and mortality were analyzed. Piecewise regression analyses were performed to assess temporal trends in SAVR utilization in females versus males. Multivariable analyses were performed to identify predictors of in-hospital mortality. RESULTS: A total of 392,087 hospitalizations for SAVR across the USA were analyzed. Utilization of SAVR in both sex patients decreased significantly during the years 2011-2017. Males compared to females had significantly higher rates of hyperlipidemia, chronic renal disease, peripheral artery disease, coronary artery disease and tended to be smokers. Differences in mortality rates among sexes were observed for SAVR procedures. Women had higher in-hospital mortality with 3.7% compared to men with 2.5% (OR 1.38 [95% CI 1.33-1.43, P<0.001]). In a multivariable regression model analysis adjusted for potential confounders, women had higher mortality risk with odd ratio (OR 1.38 [95% CI 1.33-1.43], P<0.001). Women had significantly higher rates of vascular complications (5.1% compared to men with 4.6%, P=0.002). CONCLUSIONS: Utilization of SAVR showed a downward trend during the study period. Higher in-hospital mortality was recorded in females compared to males.

Multipole analysis of heart rate variability as a predictor of imminent ventricular arrhythmias in ICD patients.

BACKGROUND: Contemporary implantable cardiac defibrillators (ICD) enable storage of multiple, preepisode R-R recordings in patients who suffered from ventricular tachyarrhythmia (VTA). Timely prediction of VTA, using heart rate variability (HRV) analysis techniques, may facilitate the implementation of preventive and therapeutic strategies. AIM: To evaluate the novel multipole method of the HRV analysis in prediction of imminent VTAs in ICD patients. METHODS: We screened patients from the Biotronik HAWAI Registry (Heart Rate Analysis with Automated ICDs). A total of 28 patients from the HAWAI registries (phase I and II), having medical records, who had experienced documented, verified VTA during the 2-year follow-up, were included in our analysis. HRV during preepisode recordings of 4,500 R-R intervals were analyzed using the Dyx parameter and compared to HRV of similar length recordings from the same patients that were not followed by arrhythmia. RESULTS: Our study population consisted mainly of men 25 of 28 (89%), average age of 64.8 ± 9.4 years, 92% with coronary artery disease. HRV during 64 preevent recordings (2.3 events per patient on average) was analyzed and compared with 60 control recordings. The multipole method of HRV analysis showed 50% sensitivity and 91.6% specificity for prediction of ventricular tachycardia/ventricular fibrillation in the study population, with 84.5% positive predictive value. No statistically significant correlation was found between various clinical parameters and the sensitivity of imminent VTA predetection in our patients. CONCLUSION: The multipole method of HRV analysis emerges as a highly specific, possible predictor of imminent VTA, providing an early warning allowing to prepare for an arrhythmic episode.

The Relationship between Body Mass Index and In-Hospital Mortality in Bacteremic Sepsis.

BACKGROUND: The association between Body Mass Index (BMI) and clinical outcomes following sepsis continues to be debated. We aimed to investigate the relationship between BMI and in-hospital clinical course and mortality in patients hospitalized with bacteremic sepsis using real-world data. METHODS: A sampled cohort of patients hospitalized with bacteremic sepsis between October 2015 and December 2016 was identified in the National Inpatient Sample (NIS) database. In-hospital mortality and length of stay were defined as the relevant outcomes. Patients were divided into 6 BMI (kg/m2) subgroups; (1) underweight ≤ 19, (2) normal-weight 20-25, (3) over-weight 26-30, (4) obese I 31-35, (5) obese II 36-39, and (6) obese stage III ≥ 40. A multivariable logistic regression model was used to find predictors of mortality, and a linear regression model was used to find predictors of an extended length of stay (LOS). RESULTS: An estimated total of 90,760 hospitalizations for bacteremic sepsis across the U.S. were analyzed. The data showed a reverse-J-shaped relationship between BMI and study population outcomes, with the underweight patients (BMI ≤ 19 kg/m2) suffering from higher mortality and longer LOS as did the normal-weight patients (BMI 20-25 kg/m2) when compared to the higher BMI groups. The seemingly protective effect of a higher BMI diminished in the highest BMI group (BMI ≥ 40 kg/m2). In the multivariable regression model, BMI subgroups of ≤19 kg/m2 and ≥40 kg/m2 were found to be independent predictors of mortality. CONCLUSIONS: A reverse-J-shaped relationship between BMI and mortality was documented, confirming the "obesity paradox" in the real-world setting in patients hospitalized for sepsis and bacteremia.

Single- Versus Dual-Chamber Implantable Cardioverter-Defibrillator for Primary Prevention of Sudden Cardiac Death in the United States.

Background Routine addition of an atrial lead during an implantable cardioverter-defibrillator (ICD) implantation for primary prevention of sudden cardiac death, in patients without pacing indications, was not shown beneficial in contemporary studies. We aimed to investigate the use and safety of single- versus dual-chamber ICD implantations in these patients. Methods and Results Using the National Inpatient Sample database, we identified patients with no pacing indications who underwent primary-prevention ICD implantation in the United States between 2015 and 2019. Sociodemographic and clinical characteristics, as well as in-hospital complications, were analyzed. Multivariable logistic regression was used to identify predictors of in-hospital complications. An estimated total of 15 940 patients, underwent ICD implantation for primary prevention of sudden cardiac death during the study period, 8860 (55.6%) received a dual-chamber ICD. The mean age was 64 years, and 66% were men. In-hospital complication rates in the dual-chamber ICD and single-chamber ICD group were 12.8% and 10.7%, respectively (P<0.001), driven by increased rates of pneumothorax/hemothorax (4.6% versus 3.4%; P<0.001) and lead dislodgement (3.6% versus 2.3%; P<0.001) in the dual-chamber ICD group. Multivariable analyses confirmed atrial lead addition as an independent predictor for "any complications" (odds ratio [OR], 1.1 [95% CI, 1.0-1.2]), for pneumo/hemothorax (odds ratio, 1.1 [95% CI, 1.0-1.4]), and for lead dislodgement (odds ratio, 1.3 [95% CI, 1.1-1.6]). Conclusions Despite lack of evidence for clinical benefit, dual-chamber ICDs are implanted for primary prevention of sudden cardiac death in a majority of patients who do not have pacing indication. This practice is associated with increased risk of periprocedural complications. Avoidance of routine implantation of atrial leads will likely improve safety outcomes.

The Relationship Between Body Mass Index and In-hospital Survival in Patients Admitted With Acute Heart Failure.

Background: The association between Body Mass Index (BMI) and clinical outcomes following acute heart failure (AHF) hospitalization is debated in the literature. Our objective was to study the real-world relationship between BMI and in-hospital mortality in patients who were admitted with AHF. Methods: In this retrospective, multi-center study, we utilized the National Inpatient Sample (NIS) database to identify a sampled cohort of patients who were hospitalized with AHF between October 2015 and December 2016. Outcomes of interest included in-hospital mortality and length of stay (LOS). Patients were divided into 6 BMI (kg/m2) subgroups according to the World Health Organization (WHO) classification: (1) underweight ≤ 19, (2) normal weight 20-25, (3) overweight 26-30, (4) obese I 31-35, (5) obese II 36-39, and (6) extremely obese ≥40. A multivariable logistic regression model was used to identify predictors of in-hospital mortality and to identify predictors of LOS. Results: A weighted total of 219,950 hospitalizations for AHF across the US were analyzed. The mean age was 66.3 ± 31.5 years and most patients (51.8%) were male. The crude data showed a non-linear complex relationship between BMI and AHF population outcomes. Patients with elevated BMI exhibited significantly lower in-hospital mortality compared to the underweight and normal weight study participants (5.5, 5,5, 2,8, 1.6, 1.4, 1.6% in groups by BMI ≤ 19, 20-25, 26-30, 31-35, 36-39, and, ≥40 respectively, p < 0.001) and shorter LOS. In the multivariable regression model, BMI subgroups of ≤ 25kg/m2 were found to be independent predictors of in-hospital mortality. Age and several comorbidities, and also the Deyo Comorbidity Index, were found to be independent predictors of increased mortality in the study population. Conclusion: A reverse J-shaped relationship between BMI and mortality was documented in patients hospitalized for AHF in the recent years confirming the "obesity paradox" in the real-world setting.

The Obesity Paradox in Real-World Nation-Wide Cohort of Patients Admitted for a Stroke in the U.S.

Background: Obesity has been associated with increased incidence and severity of various cardiovascular risk factors and increased risk for stroke. However, the evidence of its effect on outcomes in stroke victims have been equivocal. We aimed to investigate the distribution of BMI in a nation-wide cohort of individuals, admitted for a stroke, and the relationship between BMI and in-hospital mortality. Methods: Data from the U.S. National Inpatient Sample (NIS) was collected, to identify hospitalizations for stroke, between October 2015 and December 2016. The patients were sub-divided into six groups based on their BMI: underweight, normal weight, overweight, obese I, obese II and extremely obese groups. Various sociodemographic and clinical parameters were gathered, and incidence of mortality and the length of hospital stay were analyzed. Multivariable analysis was performed to identify independent predictors of in-hospital mortality. Results: A weighted total of 84,185 hospitalizations for stroke were included in the analysis. The approximate mean patients aged was 65.5 ± 31 years, the majority being female (55.3%) and white (63.1%). The overall in-hospital mortality during the study period was 3.6%. A reverse J-shaped relationship between the body mass index and in-hospital mortality was documented, while patients with elevated BMI showed significantly lower in-hospital mortality compared to the underweight and normal weight study participants, 2.8% vs. 7.4%, respectively, p < 0.001. Age and several comorbidities, as well as the Deyo Comorbidity Index, were found to predict mortality in a multivariable analysis. Conclusion: A reverse J-shaped relationship between body mass index and in-hospital mortality was documented in patients admitted for a stroke in the U.S. during the study period. The above findings support the existence of an "obesity paradox" in patients hospitalized following a stroke, similar to that described in other cardiovascular conditions.

Left atrial appendage exclusion in atrial fibrillation.

Although oral anticoagulants (OACs) are first-line therapy for stroke prevention in patients with atrial fibrillation (AF), some patients cannot be treated with OACs due to absolute or relative contraindications. Left atrial appendage (LAA) exclusion techniques have been developed over the years as a therapeutic alternative for stroke prevention. In this paper, we review the evolution of surgical techniques, employed as an adjunct to cardiac surgery or as a stand-alone procedure, as well as the recently introduced and widely utilized percutaneous LAA occlusion techniques. Until recently, data on surgical LAAO were limited and based on non-randomized studies. We focus on recently published randomized data which strongly support an add-on surgical LAAO in eligible patients during cardiac surgery and could potentially change current practice guidelines. In recent years, the trans-catheter techniques for LAA occlusion have emerged as another, less invasive alternative for patients who cannot tolerate oral anticoagulation. We review the growing body of evidence from prospective studies and registries, focusing on the two systems which are in widespread clinical use nowadays: the Watchman and Amulet type devices. These data show favorable results for both Watchman and Amulet devices, setting them as an important tool in our arsenal for stroke reduction in AF patients, especially in those who have contraindications for OACs. A better understanding of the different therapeutic alternatives, their specific benefits, and downfalls in different patient populations can guide us in tailoring the optimal therapeutic approach for stroke reduction in our AF patients.