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Cardiac implantable electronic devices, including implantable cardioverter-defibrillators and therapy, are part of guideline-indicated treatment for a subset of patients with heart failure with reduced ejection fraction. Current technological advancements in cardiac implantable electronic devices have allowed the detection of specific physiological parameters that are used to forecast clinical decompensation through algorithmic, multiparameter remote monitoring. Other recent emerging technologies, including cardiac contractility modulation and baroreflex activation therapy, may provide symptomatic or physiological benefits in patients without indications for cardiac resynchronization. Our goal in this state-of-the-art review is to describe the new commercially available technologies, their purported mechanisms of action, and the evidence surrounding their clinical roles, limitations and future directions. Finally, we underline the need for standardized workflow and close interdisciplinary management of this population to ensure the delivery of high-quality care.

Introduction Prospective studies on rivaroxaban and apixaban have shown the safety and efficacy of direct anticoagulation agents (DOAC)s used peri-procedurally during radiofrequency ablation (RFA) of atrial fibrillation (AF). Studies comparing the two agents have not been performed. Methods Consecutive patients from a prospective registry who underwent RFA of AF between April 2012 and March 2015 and were on apixaban or rivaroxaban were studied. Clinical variables and outcomes were noted. Results There were a total of 358 patients (n = 56 on apixaban and n = 302 on rivaroxaban). There were no differences in baseline characteristics between both groups. The last dose of rivaroxaban was administered the night before the procedure in 96% of patients. In patients on apixaban, 48% of patients whose procedure was in the afternoon took the medication on the morning of the procedure. TIA/CVA occurred in 2 patients (0.6%) in rivaroxaban group with none in apixaban group (p = 0.4). There was no difference in the rate of pericardial effusion between apixaban and rivaroxaban groups [1.7% vs 0.6% (p = 0.4)]. Five percent of patients in both groups had groin complications (p = 0.9). In apixaban group, all groin complications were small hematomas except one patient who had a pseudoaneurysm (1.6%). One pseudo-aneurysm, 1 fistula and 3 large hematomas were noted in patients on rivaroxaban (1.7%) with the rest being small hematomas. DOACs were restarted post procedure typically 4 h post hemostasis. Conclusions Peri-procedural uninterrupted use of apixaban and rivaroxaban during AF RFA is safe and there are no major differences between both groups.

Background: Preliminary reports have suggested the role of annular calcium in independently predicting pacemaker implantation after transcatheter aortic valve replacement (TAVR). Data regarding role of calcium in the aortic-valvular complex on pacemaker dependency is lacking. Hypothesis: Calcium volume and score in the aortic annular region predicts RV (right ventricle) pacing burden. Methods: We conducted a retrospective single-center study at our tertiary care center including patients who had new pacemaker implantation after TAVR procedure (n=47). Standard calcium scoring software was used to demarcate and quantify the calcium along the aortic cusps and subvalvular region and dichotomized into septal and non-septal based on proximity to the interventricular septum. Standard statistical tests were used for analysis with two-sided p-value Results: The mean age was 78.6 ± 10.3 years and females were 42.6%. At baseline, 44.7% had narrow QRS complex, with 31.9% had right bundle branch block (RBBB), 8.5% had left bundle branch block (LBBB). Median Pre-TAVR QRS duration was 112 ms. Median septal and non-septal calcium score were 646 and 474 with a volume of 441 mm 3 and 327.2 mm 3 , respectively. Patients with progression to complete heart block (CHB) during index admission had significantly higher non-septal volume (650 mm 3 vs 344 mm 3 ;p=0.01) and score (892 vs 485;p=0.01) when compared to progression after discharge. Similarly, the high burden of RV pacing (>40%) was associated with lower septal calcium score (989 vs 552, p= 0.03) and volume (717 mm 3 vs 385 mm 3 , p=0.03) within 3 months of TAVR. No septal or non-septal parameters were predictive of pacing burden for mid-term (3-12 months) and long-term (>12 months) follow up. Septal calcium parameters were not predictive of RV pacing burden or progression to CHB. Conclusion: Quantitative calcium in the non-septal and septal regions were predictive of early progression to CHB and a higher burden of RV pacing, respectively. Larger scale studies on calcium distribution and the burden should be performed to validate our findings.

Introduction: Subcutaneous ICD (S-ICD) implantation is a viable alternative to transvenous ICD implantation in patients without a pacing indication. The S-ICD lead is placed near the sternum. The safety of S-ICD implantation and risk for inappropriate shocks is uncertain in patients with prior sternotomy. Methods: This single-center retrospective cohort study included patients that had implantation of an S-ICD between February 2014 - May 2020. The 30-day complication rates and long-term risks of inappropriate shocks were compared between patients with and without prior sternotomy. Results: Ninety-eight patients (52 ± 15 years old, 43% men, BMI 29 ± 6, 72% primary prevention, 28% ischemic cardiomyopathy, median LVEF 30% (IQR 25-45%)) underwent S-ICD implantation, among whom 19 (19.4%) had a prior sternotomy. The median time between sternotomy and S-ICD implantation was 96 (IQR 4.1-306) months. The sternal coil was primarily implanted left of the sternum (n=17/19, 89%). A two-incision technique was used in 79% of patients with prior sternotomy vs. 65% without sternotomy (p=0.23). The 30-day complication rate was similar between those with and without prior sternotomy (n=1/19 vs. n=10/79, 5% vs. 13%, p=0.36). The only 30-day complication in patients with prior sternotomy was a hematoma without intervention. The 30-day complications in patients without prior sternotomy included: superficial site infection resolving with brief antibiotics (n=4), inappropriate shock (n=3), lead migration requiring revision (n=2), and a hematoma without intervention (n=1). Over a median follow-up of 17.1 (IQR 3.4-29.1) months, the frequency of inappropriate shocks was similar between patients with and without prior sternotomy (n=1/19 and n=6/79, 5% vs. 8%, p=0.72). The median time to inappropriate shock from S-ICD implantation was 1.1 (IQR 0.1-19.8) months. The mechanisms of inappropriate shocks were T-wave oversensing or other oversensing (n=5/7, 72%), air in the pocket (n=1/7, 14%), and atrial tachycardia (n=1/7, 14%). Conclusions: Implantation of S-ICD in patients with prior sternotomy was not associated with an increased risk of 30-day complications or inappropriate shocks. These outcomes need to be confirmed in larger, multicenter studies.

Introduction: The Emory risk score has been developed to predict new pacemaker implantation in patients undergoing TAVR procedures. There is limited data on assessing risk of early versus late pacemaker implantation in these patients. Hypothesis: The Emory risk score is similar for patients with both early and late pacemaker implantation in TAVR patients. Methods: A single center observational study was performed at our tertiary care center. All patients who underwent pacemaker implantation after TAVR procedures were included. Patients were categorized as early or late if they had pacemaker implantation within the same admission versus implantation post discharge. Standard statistical tests were used for analysis with two-sided p value Results: A total of 97 patients were studied between January 2017 to April 2020. The mean age was 77.5 ± 7 years and females were 41.2%. At baseline patients with early implantation of pacemakers (n=66) had a higher proportion of underlying RBBB (45.2% vs 23.3%, p=0.43), higher valve size as well as a higher incidence of valve oversizing > 146% (43.9 % vs 19.4 %, p =0.23)when compared to patients with late pacemakers(n=31). There was no difference between patient characteristics, baseline comorbidities, pre procedural ECG parameters as well as use of beta blocking agents. Late pacemaker implantations were associated with a overall lower Emory Risk score (1.06±1.41 vs 1.70±1.35, p =0.037). Conclusions: The Emory Risk score is significantly different for early and late pacemaker implantation. Further studies are needed evaluate risk of late pacemaker implantation.

Introduction: Cardiac resynchronization therapy (CRT) upgrade is indicated for improvement of cardiac function in patients with chronic right ventricular (RV) pacing burden >40% and heart failure with reduced ejection fraction. It is uncertain whether the CRT response is different among patients with high (≥90%) versus intermediate ( Hypothesis: To assess the impact of baseline RV pacing percent on ECG and echocardiographic response after CRT upgrade for pacing induced cardiomyopathy. Methods: We conducted a retrospective study of all CRT upgrades for pacing induced cardiomyopathy at our hospital from January 2017 to December 2018. Cohorts were grouped by RV pacing burden ≥90% or Results: We included 82 patients (age 74 ± 12 yr., 71% male) who underwent CRT upgrade for pacing induced cardiomyopathy. The RV pacing burden was ≥90% [median 99% (IQR 98-99%)] in 61 patients, and Conclusions: A higher baseline RV pacing burden predicts a greater improvement in LVEF after CRT upgrade for pacing induced cardiomyopathy.

BACKGROUND The safety of perioperative anticoagulation (AC) and antiplatelet (AP) therapy with subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation is unknown. The purpose of this study was to identify the risk factors associated with hematoma complicating S-ICD implantation. METHODS Records were retrospectively reviewed from 200 consecutive patients undergoing S-ICD implantation at two academic medical centers. A hematoma was defined as a device site blood accumulation requiring surgical evacuation, extended hospital stay, or transfusion. RESULTS Among 200 patients undergoing S-ICD implantation (age 49 ± 17 years, 67% men), 10 patients (5%) had a hematoma, which required evacuation in six patients (3%). Warfarin was bridged or uninterrupted in 12 and 13 patients, respectively (6% and 6.5%). Four of 12 patients with warfarin and bridging AC (33%) and two of 13 patients with uninterrupted warfarin (15%) developed a hematoma. Neither of the two patients with uninterrupted DOAC had a hematoma. No patients on interrupted AC without bridging (n = 26, 13 with warfarin, 13 with DOAC) developed a hematoma. A hematoma was also more likely with the use of clopidogrel (n = 4/10 vs 10/190, 40% vs 5.3%, P

Introduction: Management of voluminous data from implantable cardiac devices is resource intensive. False positive events can be especially problematic with implantable loop recorders (ILRs). We sought to describe our early experience with a novel ILR. Hypothesis: Sensitivity adjustment to Methods: A single center retrospective study was performed in patients with the Abbott Confirm RX ILR. Tachycardia, atrial fibrillation (AF), bradycardia, and pause events were reviewed to determine whether they were true or false positives. Results: The study included 13 patients (age 67 ±15.8 years, 62% men). The reasons for implant included: AF (n=7, 54%), syncope(n=3, 23%), palpitations (n=2, 15%), and stroke (n=1, 8%). The median follow-up duration was 3.1 months (IQR 1.3-4.4 months). There was no change in serial R waves during mean follow-up of 0.58 months (pre 0.62±0.22 mV, post 0.63±0.22 mV, p=0.52). Tachycardia detection occurred in 6 patients (46%), with only 1 patient having a false positive episode. AF detection occurred in 8 patients (62%), with only 2 patients having true AF episodes. Pause/bradycardia episodes were detected in 5 patients (39%), with false positive episodes in 4 patients. There was no difference in R waves at implant among patients with and without false positive bradycardia/pauses episodes (0.66 ±0.27 vs. 0.44 ± 0.28 mV, p=0.21). The max sensitivity was higher among patients with than without false positive bradycardia/pause episodes (0.14 ±0.01, 0.07 ±0.02 mV, p Conclusion: Programming the novel ILR to a sensitivity of

Background Despite ACC/AHA guidelines indicating implantable cardioverter defibrillator (ICD) as class I therapy for primary prevention of sudden cardiac death in patients with EF≤35%, ICD utilization rates in real world practice have been low. Objective To determine the rate of ICD implantation at a tertiary care academic center and to assess the reasons for under-utilization of the same. Methods Review of a prospectively collected database which included all patients diagnosed with an EF≤35% was performed to assess the rate of ICD implantation and mortality. Reasons for non-implantation of ICD were then assessed from detailed chart review. Results A total of 707 patients (age 69.4 ± 14.1 years) with mean EF of 26±7% were analyzed. Only 28% (200/707) of patients had ICDs implanted. Mortality was lower in the group with ICD (25% vs 37%, p=0.004). When patients who either died or were lost to follow-up prior to 2005 were excluded, ICD utilization rate was still low at 37.6%. The most common reason for non-implantation of ICD was physicians not discussing this option with their patients. Patient refusal was the second most common reason. Conclusions ICD Implantation rates for primary prevention of SCD in patients with EF≤35% is low. Physician and patient education should be addressed to improve the utilization rates.

Background Use of corticosteroids before and after atrial fibrillation (AF) ablation can decrease acute inflammation and reduce AF recurrence. Purpose To assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation and its effect on inflammatory cytokine. Methods A total of 60 patients with paroxysmal AF undergoing radiofrequency ablation were randomized (1:1) to receive either 3 doses of 60 mg daily of oral prednisone or a placebo. Inflammatory cytokine levels (TNF-α, IL-1, IL6, IL-8) were measured at baseline, prior to ablation, immediately after ablation, and 24 hours post ablation. Patients underwent 30 day event monitoring at 3 months, 6 months and 12 months post procedure. Results Immediate post ablation levels of inflammatory cytokines were lower in the steroid group when compared to the placebo group; IL-6: 9.0 ±7 vs 15.8 ±13 p=0.031; IL-8: 10.5 ±9 vs 15.3 ±8; p=0.047 respectively. Acute PV reconnection rates during the procedure (7/23% vs 10/36%; p = 0.39), and RF ablation time (51±13 vs 56±11 min, p = 0.11) trended to be lower in the placebo group than the steroid group. There was no difference in the incidence of early recurrence of AF during the blanking period and freedom from AF off AAD at 12 months between both groups (5/17% vs 8/27%; p = 0.347 and 21/70% vs 18/60%; p=0.417 in placebo and steroid groups respectively). Conclusion Although oral corticosteroids have significant effect in lowering certain cytokines, it did not impact the clinical outcomes of AF ablation.

Cryoballoon pulmonary vein (PV) isolation/ablation is an efficacious treatment of paroxysmal and early persistent atrial fibrillation (AF), including in patients with left common (LC) PV anatomy. The efficacy of cryoballoon ablation is unknown in patients with right middle or accessory (RMA) PVs.

Women are at lower risk for development of sudden cardiac death (SCD) as compared with men. Women with SCD tend to have less structural heart disease and preserved left ventricular systolic function. Coronary artery disease (CAD) is the most common predictor of SCD in women, as it is in men. However, women with SCD are less likely to have underlying CAD than men, suggesting the need to identify risk factors other than CAD or systolic dysfunction for its prediction in women. SCD risk factors in women include heart failure with preserved left ventricular systolic function, abnormal sympathetic uptake as assessed by meta-iodobenzylguanidine uptake, depression, and/or use of antidepressants. This article reviews SCD in women and discusses areas for future research.

Objectives The purpose of this study was to evaluate the feasibility and safety of uninterrupted rivaroxaban therapy during atrial fibrillation (AF) ablation. Background Optimal periprocedural anticoagulation strategy is essential for minimizing bleeding and thromboembolic complications during and after AF ablation. The safety and efficacy of uninterrupted rivaroxaban therapy as a periprocedural anticoagulant for AF ablation are unknown. Methods We performed a multicenter, observational, prospective study of a registry of patients undergoing AF ablation in 8 centers in North America. Patients taking uninterrupted periprocedural rivaroxaban were matched by age, sex, and type of AF with an equal number of patients taking uninterrupted warfarin therapy who were undergoing AF ablation during the same period. Results A total of 642 patients were included in the study, with 321 in each group. Mean age was 63 ± 10 years, with 442 (69%) males and 328 (51%) patients with paroxysmal AF equally distributed between the 2 groups. Patients in the warfarin group had a slightly higher mean HAS- BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score (1.70 ± 1.0 vs. 1.47 ± 0.9, respectively; p = 0.032). Bleeding and embolic complications occurred in 47 (7.3%) and 2 (0.3%) patients (both had transient ischemic attacks) respectively. There were no differences in the number of major bleeding complications (5 [1.6%] vs. 7 [1.9%], respectively; p = 0.772), minor bleeding complications (16 [5.0%] vs. 19 [5.9%], respectively; p = 0.602), or embolic complications (1 [0.3%] vs. 1 [0.3%], respectively; p = 1.0) between the rivaroxaban and warfarin groups in the first 30 days. Conclusions Uninterrupted rivaroxaban therapy appears to be as safe and efficacious in preventing bleeding and thromboembolic events in patients undergoing AF ablation as uninterrupted warfarin therapy.

Patients presenting with frequent ventricular arrhythmias can have underlying myocardial inflammation as an inciting factor. We seek to determine whether the site of origin (SOO) of ventricular arrhythmias on 12 lead EKG correlate with areas of inflammation on FDG PET cardiac imaging in patients

Patients with cardiac implantable electronic devices (CIEDs) frequently have arrhythmias warranting catheter ablation (CA). The risk of lead dislodgement with CA in patients with CIED implant within 1 year is uncertain. We retrospectively evaluated patients undergoing CA of arrhythmias at an

Cardiac myocytes can rapidly adjust their expression of gap junction channel proteins in response to changes in load. Previously, we showed that after only 1 hour of linear pulsatile stretch (110% of resting cell length; 3 Hz), expression of connexin43 (Cx43) by cultured neonatal rat ventricular myocytes is increased by approximately 2-fold and impulse propagation is significantly more rapid. In the present study, we tested the hypothesis that vascular endothelial growth factor (VEGF), acting downstream of transforming growth factor-beta (TGF-beta), mediates stretch-induced upregulation of Cx43 expression by cardiac myocytes. Incubation of nonstretched cells with exogenous VEGF (100 ng/mL) or TGF-beta (10 ng/mL) for 1 hour increased Cx43 expression by approximately 1.8-fold, comparable to that observed in cells subjected to pulsatile stretch for 1 hour. Stretch-induced upregulation of Cx43 expression was blocked by either anti-VEGF antibody or anti-TGF-beta antibody. Stretch-induced enhancement of conduction was also blocked by anti-VEGF antibody. ELISA assay showed that VEGF was secreted into the culture medium during stretch. Furthermore, stretch-conditioned medium stimulated Cx43 expression in nonstretched cells. This effect was also blocked by anti-VEGF antibody. Upregulation of Cx43 expression stimulated by exogenous TGF-beta was blocked by anti-VEGF antibody, but VEGF-stimulation of Cx43 expression was not blocked by anti-TGF-beta antibody. Thus, stretch-induced upregulation of Cx43 expression is mediated, at least in part, by VEGF, which acts downstream of TGF-beta. Because the cultures contained only approximately 5% nonmyocytic cells, these results indicate that myocyte-derived VEGF, secreted in response to stretch, acts in an autocrine fashion to enhance intercellular coupling.

Background: Very recently St Jude Medical (SJM) released an advisory regarding premature battery depletion in a family of implantable cardioverter-defibrillators (ICDs) including biventricular cardiac defibrillators (CRTDs). There have been reported cases of loss of pacing and inability to

Background— Collateral damage to the vagal nerve and the upper gastrointestinal (UGI) system during atrial fibrillation ablation has not been systematically evaluated. Methods and Results— We performed a prospective, observational study assessing the effect of atrial fibrillation ablation on the function of the vagus nerve/UGI system. All patients underwent esophageal manometry, gastric emptying study, and sham-feeding test (corresponding to esophageal, gastric, and small intestinal function evaluation, respectively) before ablation (baseline) and subsequently at 24 hours, 90 days, and 180 days after the procedure. In addition, UGI symptom assessment using the patient assessment of upper gastrointestinal disorders–symptom severity index (PAGI-SYM) questionnaire was performed at baseline and during each of the subsequent evaluations. Of the 27 patients enrolled in the study, 9 (33%) patients had abnormal UGI function at baseline; defined as at least one of the 3 abnormal tests. At 24 hours after the radiofrequency catheter ablation, 20 (74%) patients had at least 1 new abnormality on the UGI function tests ( P P =0.002) at 24 hours. New onset abnormalities persisted in 9 (33%) patients at 3 months and normalized in all patients at 6 months. Conclusions— Atrial fibrillation ablation results in functional impairment of the UGI system, including the esophagus, stomach, and small intestine. This impairment is transient and is probably mediated by the injury to the components of the vagal nerve. Clinical Trial Registration— URL: http://clinicaltrials.gov . Unique Identifier: NCT01396356.

To evaluate the real-world practice patterns of utilization of dofetilide for treating Atrial Fibrillation (AF). We performed an online survey of cardiologists and cardiac electrophysiologists in US and Europe. Participation was voluntary. 31 specific questions were included in the study, primarily

To evaluate the impact of pre-procedural oral prednisone on inflammatory cytokines (TNF-α, Interleukin (IL)-1, IL-6, and IL-8) levels and outcomes of atrial fibrillation (AF) ablation in patients with paroxysmal AF. A total of 60 patients with paroxysmal AF undergoing AF ablation were randomized (

We intended to evaluate the incidence of electrical and mechanical failure of QuickSite (QS) and QuickFlex (QF) left ventricular (LV) leads which are a part of a lead advisory. We invited all 154 alive patients who had the QS and QF leads implanted at our center to participate in this prospective

The purpose of this study was to evaluate the feasibility and safety of periprocedural dabigatran during atrial fibrillation (AF) ablation.AF ablation requires optimal periprocedural anticoagulation for minimizing bleeding and thromboembolic complications. The safety and efficacy of dabigatran as a periprocedural anticoagulant for AF ablation are unknown.We performed a multicenter, observational study from a prospective registry including all consecutive patients undergoing AF ablation in 8 high-volume centers in the United States. All patients receiving dabigatran therapy who underwent AF ablation on periprocedural dabigatran, with the dose held on the morning of the procedure, were matched by age, sex, and type of AF with an equal number of patients undergoing AF ablation with uninterrupted warfarin therapy over the same period.A total of 290 patients, including 145 taking periprocedural dabigatran and an equal number of matched patients taking uninterrupted periprocedural warfarin, were included in the study. The mean age was 60 years with 79% being male and 57% having paroxysmal AF. Both groups had a similar CHADS(2) score, left atrial size, and left ventricular ejection fraction. Three thromboembolic complications (2.1%) occurred in the dabigatran group compared with none in the warfarin group (p = 0.25). The dabigatran group had a significantly higher major bleeding rate (6% vs. 1%; p = 0.019), total bleeding rate (14% vs. 6%; p = 0.031), and composite of bleeding and thromboembolic complications (16% vs. 6%; p = 0.009) compared with the warfarin group. Dabigatran use was confirmed as an independent predictor of bleeding or thromboembolic complications (odds ratio: 2.76, 95% confidence interval: 1.22 to 6.25; p = 0.01) on multivariate regression analysis.In patients undergoing AF ablation, periprocedural dabigatran use significantly increases the risk of bleeding or thromboembolic complications compared with uninterrupted warfarin therapy.