The impact of peri-procedural imaging on safety and efficacy of atrial fibrillation ablation: insights from the Israeli AF Catheter Ablation Registry (ICAR).

BACKGROUND: Pulmonary vein isolation (PVI) is the most effective therapy to achieve rhythm control in atrial fibrillation (AF). Peri-procedural imaging is used in many but not all centers. However, the impact of imaging on safety and efficacy of PVI is not clear. The Israeli Catheter Ablation Registry (ICAR) is a great opportunity to explore this issue in real-world practice. AIM: To describe the real-world utilization of peri-procedural imaging technologies in a large cohort of patients undergoing ablation for AF. METHODS: A prospective-multicenter cohort of AF patients who underwent PVI during the years 2019-2021. Peri-procedural imaging (CT, ICE, TEE) was utilized based on the center and operator discretion. The study endpoints were peri-procedural complications and AF recurrence at 12 months follow-up among patients with and without peri-procedural imaging. RESULTS: Between January 2019 and December 2021, a total of 921 patients underwent PVI. Peri-procedural imaging (at least 1 modality of CT, TEE, and or ICE) was utilized in 753 (81.8%) and no imaging among 168 (18.2%) patients. Cryoablation was the dominant energy used for PVI in both groups (92.3% of the non-imaging group, and 95.3% among imaging group), while RF was used in the rest of the patients. Fluoroscopy time was not different between the 2 groups; however, procedure duration was longer among the imaging group (90 min) compared to the non-imaging group (74.5 min, p = 0.006). By 12 months, the incidence of AF recurrence and repeated ablation were not different between the groups. Complications and re-hospitalization for cardiocerebrovascular reasons were not different among the 2 groups. Cox regression model demonstrated no association between preprocedural imaging and the risk of AF recurrence after ablation. CONCLUSION: This real-world multicenter prospective registry study demonstrated that the rate of complications and the rate of recurrence of AF during 1 year follow-up were not different among patients who had PVI either with or without peri-procedural imaging.

Nationwide Trends in Hospitalizations for Atrial Fibrillation and Flutter in the United States before and during the Outbreak of the COVID-19 Pandemic.

Background/Objectives: Atrial fibrillation (AF) and flutter (AFL) are the most common cardiac arrhythmias worldwide. Cardiovascular complications are a common manifestation of acute and post-acute COVID-19 infection. We aimed to analyze the nationwide trends in clinical characteristics and outcomes of patients hospitalized for AF/AFL before and during the COVID-19 outbreak in the U.S. Methods: This study is a retrospective analysis of patients, aged 18 and older, hospitalized for AF/AFL in the U.S. between 2016 and 2020. We drew data from the National Inpatient Sample (NIS) database. Baseline sociodemographic and clinical data, as well as outcomes including stroke, acute coronary syndrome (ACS), and mortality, were analyzed. Multivariable analysis was performed to identify independent associations between the different clinical and demographic characteristics and the composite endpoint of Mortality/ACS/Stroke. Results: An estimated total of 2,163,699 hospitalizations for AF/AFL were identified. The hospitalization volume between 2016 and 2019 was stable, averaging 465,176 a year, followed by a significant drop to 302,995 in 2020. Patients' median age was 72 years (IQR 62-80), 50.9% were male, and 81.5% were white. The composite endpoint steadily increased from 6.5% in 2016 to 11.8% in 2020 (Ptrend < 0.001). In a multivariable regression analysis, age > 75 (OR: 1.35; 95% CI 1.304-1.399, p < 0.001), ischemic heart disease (OR: 1.466; 95% CI: 1.451-1.481; p < 0.001), and chronic kidney disease (OR: 1.635; 95% CI: 1.616-1.653; p < 0.001) were associated with the composite endpoint. COVID-19 was associated with the composite endpoint outcome in the year 2020 (OR: 1.147; 95% CI: 1.037-1.265; p = 0.007). Conclusions: Hospitalization for AF/AFL dropped significantly during the first year of the COVID-19 pandemic outbreak, possibly due to patients' avoidance of hospital visits. The composite endpoint of Mortality/ACS/Stroke uptrended significantly during the study period. COVID-19 was shown to be independently associated with the adverse composite outcome Mortality/ACS/Stroke.

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.

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.

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.

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.

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.

Sex difference and outcome trends following transcatheter aortic valve replacement.

Background: Based on worldwide registries, approximately 50% of patients who underwent transcatheter aortic valve replacement (TAVR) are female patients. Although TAVR procedures have improved tremendously in recent years, differences in outcome including mortality between sexes remain. We aimed to investigate the trends in TAVR in the early and new eras of utilization and to assess TAVR outcomes in female patients vs. male patients. Methods: Using the 2011-2017 National Inpatient Sample (NIS) database, we identified hospitalizations for patients with the diagnosis of aortic stenosis during which a TAVR was performed. Patients' sociodemographic and clinical characteristics, procedure complications, and mortality were analyzed. Piecewise regression analyses were performed to assess temporal trends in TAVR utilization in female patients and in male patients. Multivariable analysis was performed to identify predictors of in-hospital mortality. Results: A total of 150,647 hospitalizations for TAVR across the United States were analyzed during 2011-2017. During the study period, a steady upward trend was observed for TAVR procedures in both sexes. From 2011 to 2017, there were significantly more TAVR procedures performed in men [80,477 (53.4%)] than in women [70,170 (46.6%)]. Male patients had significantly higher Deyo-CCI score and comorbidities. Differences in mortality rates among sexes were observed, presenting with higher in-hospital mortality in women than in men, OR 1.26 [95% CI 1.18-1.35], p < 0.001. Conclusion: Utilization of TAVR demonstrated a steady upward trend during 2011-2017, and a similar trend was presented for both sexes. Higher in-hospital mortality was recorded in female patients compared to male patients. Complication rates decreased over the years but without effect on mortality differences between the sex groups.

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.