Same-day discharge after atrial fibrillation ablation.

Background: Atrial fibrillation (AF) catheter ablation has become an increasingly effective and safe strategy for the management of AF. With increased safety of catheter ablation, same-day discharge (SDD) is a potential way to minimize health care resource utilization and improve patient experience. Objective: To evaluate the safety and patient satisfaction of SDD after contemporary AF ablation. Methods: Consecutive patient undergoing AF ablation at our institution between 1/2020 and 10/2021 were enrolled in registry for clinical, quality, procedural and outcomes data. Patients were considered for SDD per physician discretion and patients' preference based upon clinical evaluation. Adjudicated ninety-day major complications, thirty-day adverse events, and thirty-day re-admissions were collected in a prospective registry for all patients. Results: A total of 2142 consecutive patients underwent elective AF ablation during the study period. After excluding cases with missing data, 1830 patients were included in the analysis. Of those, 350 (19 %) patients were discharged the same day (SDD group) and 1480 (81 %) stayed overnight. Patients in the SDD group compared to overnight stay group were younger, more likely to be male, White patients, lower CHA2DS2-VASc score and to be on lower rates of warfarin as an anticoagulation strategy. After propensity score matching, SDD was associated with lower rate of major complications and higher patient satisfaction. The majority of life-treating complications occurred interprocedurally or within 6 h of procedure termination. Conclusion: The present study demonstrated that SDD after contemporary AF ablation is feasible, safe and associated with higher patient satisfaction using a proposed SDD pathway and criteria.

Ischemic or Coronary Evaluations in Patients With Monomorphic VT Electrical Storm Undergoing VT Ablation.

BACKGROUND: Monomorphic ventricular tachycardia (VT) electrical storm (ES) in patients with coronary artery disease is dependent on scarred myocardium. The role of routine ischemic or coronary evaluations before ablation in patients presenting with monomorphic VT storm, without acute coronary syndrome (ACS), remains unknown. OBJECTIVES: This study sought to assess the impact of ischemic or coronary evaluations on procedural outcomes and post-ablation mortality in monomorphic VT storm patients. METHODS: All patients undergoing VT ablation at the Cleveland Clinic from 2014 to 2020 after presenting with monomorphic VT storm were enrolled in a prospectively maintained registry. The associations among ischemic or coronary evaluations and short-term procedural efficacy, acute outcomes, and mortality during follow-up were assessed. RESULTS: A total of 97 consecutive patients with monomorphic VT storm in the absence of ACS underwent VT ablations. This cohort was characterized by severe LV systolic dysfunction (mean left ventricular ejection fraction 30.3%, 67% with known ischemic cardiomyopathy) with moderately severe heart failure (median NYHA functional class II); 45% of patients underwent ischemic or coronary evaluations via coronary angiography (10%), noninvasive myocardial perfusion (26%), or both (9%). The yield of these evaluations was low: No acute coronary occlusions were identified. There was no association between ischemic evaluation and acute ablation outcomes or mortality during follow-up. Similarly, in a secondary analysis, the yield of ischemic or coronary evaluations in patients with monomorphic VT storm and known coronary disease (regardless of ablation status) was found to be low. CONCLUSIONS: Ischemic evaluations in patients with monomorphic VT storm without ACS may not improve procedural outcomes or mortality after ablation.

Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator.

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has demonstrated safety and efficacy for the treatment of malignant ventricular arrhythmias. However, a limitation of the S-ICD lies in the inability to either pace-terminate ventricular tachycardia or provide prolonged bradycardia pacing support. Objective: The rationale and design of a prospective, single-arm, multinational trial of an intercommunicative leadless pacing system integrated with the S-ICD will be presented. Methods: A technical description of the modular cardiac rhythm management (mCRM) system (EMPOWER leadless pacemaker and EMBLEM S-ICD) and the implantation procedure is provided. MODULAR ATP (Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing) is a multicenter, international trial enrolling up to 300 patients at risk of sudden cardiac death at up to 60 centers trial design. The safety endpoint of freedom from major complications related to the mCRM system or implantation procedure at 6 months and 2 years are significantly higher than 86% and 81%, respectively, and all-cause survival is significantly >85% at 2 years. Results: Efficacy endpoints are that at 6 months mCRM communication success is significantly higher than 88% and the percentage of subjects with low and stable thresholds is significantly higher than 80%. Substudies to evaluate rate-responsive features and performance of the pacing module are also described. Conclusion: The MODULAR ATP global clinical trial will prospectively test the safety and efficacy of the first intercommunicating leadless pacing system with the S-ICD. This trial will allow for robust validation of device-device communication, pacing performance, rate responsiveness, and system safety.

Atrial Fibrillation Ablation in Young Adults: Measuring Quality of Life Using Patient-Reported Outcomes Over 5 Years.

BACKGROUND: Ablation is used for both rhythm control and improved quality of life (QoL) in atrial fibrillation (AF). It has been suggested that young adults may experience high recurrence rates after ablation and data remain lacking regarding QoL benefits. We aimed to investigate AF ablation outcomes and QoL benefits in young adults undergoing AF ablation using a large prospectively maintained registry and automated patient-reported outcomes (PRO). METHODS: All patients undergoing AF ablation (2013-2016) at our center were prospectively enrolled. Patients aged 50 years or younger were included. For PROs, QoL measures and symptoms were assessed at baseline, 3 months after ablation, and every 6 months thereafter. The AF severity score served as the main assessment of QoL. RESULTS: A total of 241 young adults (age, 16-50 years) were included (17% female, 40.3% persistent AF). In all, 77.2% of patients remained arrhythmia-free during the first year of follow-up (80% in nonstructural AF and 66% in structural AF). Using PROs, 90% of patients reported improvement in QoL throughout all survey time points up to 5 years postablation (P<0.0001). The baseline median AF severity score was 14 and improved to between 2 and 4 on all follow-up after ablation (P<0.0001). Patients also reported fewer and shorter AF episodes, fewer emergency room visits secondary to AF, and fewer hospitalizations (P<0.0001). CONCLUSIONS: Ablation remains an effective rhythm-control strategy in young adults with AF. Young adults also experience significant improvement in QoL with reduction of the frequency and duration of AF episodes and AF-related healthcare utilization.

A Dual-Chamber Leadless Pacemaker.

BACKGROUND: Single-chamber ventricular leadless pacemakers do not support atrial pacing or consistent atrioventricular synchrony. A dual-chamber leadless pacemaker system consisting of two devices implanted percutaneously, one in the right atrium and one in the right ventricle, would make leadless pacemaker therapy a treatment option for a wider range of indications. METHODS: We conducted a prospective, multicenter, single-group study to evaluate the safety and performance of a dual-chamber leadless pacemaker system. Patients with a conventional indication for dual-chamber pacing were eligible for participation. The primary safety end point was freedom from complications (i.e., device- or procedure-related serious adverse events) at 90 days. The first primary performance end point was a combination of adequate atrial capture threshold and sensing amplitude at 3 months. The second primary performance end point was at least 70% atrioventricular synchrony at 3 months while the patient was sitting. RESULTS: Among the 300 patients enrolled, 190 (63.3%) had sinus-node dysfunction and 100 (33.3%) had atrioventricular block as the primary pacing indication. The implantation procedure was successful (i.e., two functioning leadless pacemakers were implanted and had established implant-to-implant communication) in 295 patients (98.3%). A total of 35 device- or procedure-related serious adverse events occurred in 29 patients. The primary safety end point was met in 271 patients (90.3%; 95% confidence interval [CI], 87.0 to 93.7), which exceeded the performance goal of 78% (P<0.001). The first primary performance end point was met in 90.2% of the patients (95% CI, 86.8 to 93.6), which exceeded the performance goal of 82.5% (P<0.001). The mean (±SD) atrial capture threshold was 0.82±0.70 V, and the mean P-wave amplitude was 3.58±1.88 mV. Of the 21 patients (7%) with a P-wave amplitude of less than 1.0 mV, none required device revision for inadequate sensing. At least 70% atrioventricular synchrony was achieved in 97.3% of the patients (95% CI, 95.4 to 99.3), which exceeded the performance goal of 83% (P<0.001). CONCLUSIONS: The dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation. (Funded by Abbott Medical; Aveir DR i2i ClinicalTrials.gov number, NCT05252702.).

Leadless cardiac ventricular pacing using helix fixation: Step-by-step guide to implantation.

INTRODUCTION: Leadless cardiac pacemakers are an alternative modality to traditional transvenous pacemaker systems. Recently receiving Food and Drug Administration approval, the AVEIR VR leadless pacemaker system provides a helix based active fixation leadless pacemaker system. This step-by-step review will cover patient selection, preprocedural planning, device implantation technique, implant site evaluation, troubleshooting, short- and long-term complications as well as future directions for leadless pacing. METHODS: We collected and reviewed cases from primary operators to provide a step-by-step review for implanters. RESULTS: Our paper provides a guide to patient selection, pre-procedural planning, device im plantation technique, implant site evaluation, troubleshooting, short- and long-term complications as well as future directions for leadless pacing. CONCLUSION: The helix based active fixation leadless pacemaker system is a safe and efficacious way to provide pacing support to patients and provides an alternative to transvenous pacing systems. Our review provides a step-by-step guide to implantation.

Impact of redo ablation for atrial fibrillation on patient-reported outcomes and quality of life.

INTRODUCTION: Catheter ablation for atrial fibrillation (AF) is frequently used for the purpose of rhythm control and improved quality of life (QoL). Although success rates are high, a significant proportion of patients require redo ablation. Data are scarce on patient-centered outcomes and QoL in patients undergoing redo AF ablation. We aimed to assess QoL and clinical outcomes using a large prospectively maintained patient-reported outcomes (PRO) registry. METHODS: All patients undergoing redo AF ablation (2013-2016) at our center were enrolled in a prospective registry for outcomes and assessed for QoL using automated PRO surveys (baseline, 3 and 6 months after ablation, every 6 months thereafter). Data were collected over 3 years of follow-up. The atrial fibrillation symptom severity scale (AFSSS) was used as the main measure for QoL. Additional variables included patient-reported improvement, AF burden, and AF-related healthcare utilization including emergency room (ER) visits and hospitalizations. RESULTS: A total of 848 patients were included (28% females, mean age 63.8, 51% persistent AF). By automated PRO, significant improvement in QoL was noted (baseline median AFSSS of 12 [5-18] and ranged between 2 and 4 on subsequent assessments; p < .0001), with ≥70%of patients reported remarkable improvement in their AF-related symptoms. The proportion of patients in AF at the time of baseline survey was 36%, and this decreased to <8% across all time points during follow-up (p < .0001). AF burden was significantly reduced (including frequency and duration of episodes; p < .0001), with an associated decrease in healthcare utilization after 6 months from the time of ablation (including ER visits and hospitalizations; p < .0001). The proportion of patients on anticoagulants or antiarrhythmics decreased on follow-up across all time points (p < .0001 for all variables). CONCLUSION: Most patients derive significant QoL benefit from redo AF ablation; with reduction of both AF burden and healthcare utilization.

Wireless Communication Between Paired Leadless Pacemakers for Dual-Chamber Synchrony.

BACKGROUND: Leadless pacemakers (LPs) can mitigate conventional pacemaker complications related to the transvenous leads and subcutaneous pocket surrounding the pulse generator. Although single-chamber leadless pacing has been established, multichamber pacing requires wireless bidirectional communication across multiple LPs to maintain synchrony. This preclinical study demonstrates the chronic performance of implant-to-implant (i2i) communication that achieves synchronous, dual-chamber pacing with 2 LPs. METHODS: The i2i communication modality employs subthreshold electrical signals conducted between implanted LPs through the blood and myocardial tissue on a beat-by-beat basis. Right atrial and right ventricular LPs were implanted in 9 ovine subjects. The i2i transmission performance was evaluated 13 weeks after implant. RESULTS: Right atrial and right ventricular LPs were implanted successfully and without complication in 9 ovine subjects. A total of 8715±457 right atrial-to-right ventricular and right ventricular-to-right atrial transmissions were sent per hour, with a success rate of 99.2±0.9%. Of periods with i2i communication failure when DDD pacing was not possible, 97.3±1.8% were resolved within 6 s. CONCLUSIONS: For the first time, synchronized, dual-chamber pacing has been demonstrated in a chronic preclinical feasibility study by 2 leadless pacemakers using beat-to-beat, wireless communication, achieving a success rate of 99.2%.

Acute pericarditis after atrial fibrillation ablation: Incidence, characteristics, and risk factors.

Background: Little is known about the incidence and risk factors for the development of acute pericarditis after ablation for atrial fibrillation (AF). Objective: The purpose of this retrospective cohort study was to describe the occurrence of and associations with suspected acute pericarditis after AF ablation. Methods: All patients undergoing AF ablation in our center were enrolled in a prospectively maintained registry. Suspected acute pericarditis was defined as pericardial chest pain treated with disease specific anti-inflammatories within 3 months of AF ablation. Results: Among 2215 patients with AF ablations between January 1, 2018, and December 31, 2019, 226 (10.2%) had suspected acute pericarditis. Treatments included colchicine in 149 patients (65.9%), prednisone in 66 (29.2%), and high-dose ibuprofen in 43 (19.0%). Multiple anti-inflammatory therapies were used in 57 patients (25%). At baseline, a lower CHADS2VASc score and a higher body mass index were associated with pericarditis, whereas older patients were less likely to have pericarditis. With multivariable adjustment, age was associated with suspected acute pericarditis (odds ratio 0.95; 95% confidence interval 0.94-0.97; P <.0001). Among patients with suspected pericarditis, postprocedure pericardial effusion was present in 9.3% and pericarditis electrocardiographic changes in 19.5%. Conclusion: Suspected acute pericarditis is common after AF ablation and is associated with a younger age. Systematic assessments for acute pericarditis after AF ablation should be considered.

Outcomes of atrial fibrillation ablation in patients with or without silent pulmonary veins from prior ablation procedure.

INTRODUCTION: Pulmonary venous (PV) electrical recovery underlies most arrhythmia recurrences after atrial fibrillation (AF) ablation. Little is known about procedural profiles and outcomes of patients with electrically silent PVs upon redo ablation for AF. METHODS: In a prospectively maintained registry, we enrolled 838 consecutive patients (2013-2016) undergoing redo ablation procedures. Ablation procedures targeted the PVs, the PV antra, and non-PV sites at operators' discretion. Procedural profiles and clinical outcomes were assessed. The primary outcome was freedom from AF after a 3-month blanking period. The secondary outcome was improvement in quality of life. RESULTS: Most patients undergoing redo AF ablation (n = 684, 82%) had PV reconnection while the remaining 154 (18%) had electrically silent PVs. Patients with recurrent AF and electrically silent PVs were older (66 vs. 64 years, p = .02), had more prior ablation procedures (median 2 IQR 1-3 vs 1 IQR 1-2 p = .001), were more likely to have non-paroxysmal AF (62% vs. 49%, p = .004) and atrial flutter (48% vs. 29%, p = .001) and had significantly larger left atrial volumes (89 vs. 81 ml, p = .003). Patients with silent PVs underwent a more extensive non-PV ablation strategies with antral extension of prior ablation sets in addition to ablation of the roof, appendage, inferior to the right PVs, peri-mitral flutter lines, cavotricuspid isthmus lines and ablation in the coronary sinus. Upon one year of follow-up, patients with electrically silent PVs were less likely to remain free from recurrent atrial arrhythmias (64% vs. 76%, p = .008). Regardless of PV reconnection status, redo ablation resulted in improvement in quality of life. CONCLUSION: Rhythm control with extensive ablation allowed maintenance of sinus rhythm in about two thirds of patients with silent PVs during redo AF ablation procedures. Regardless of PV reconnection status, redo ablation resulted in improvement in quality of life. This remains a challenging group of patients, highlighting the need to better understand non-PV mediated AF.

Contemporary maternal and fetal outcomes in the treatment of LQTS during pregnancy: Is nadolol bad for the fetus?

BACKGROUND: ß-Blocker therapy, specifically nadolol, is the recommended treatment for long QT syndrome (LQTS). Previous studies assessing maternal and fetal outcomes were published before the nadolol era. OBJECTIVE: The purpose of this study was to examine contemporary maternal and fetal outcomes in the treatment of LQTS during pregnancy. METHODS: We queried the Inherited Arrhythmia Database at Cleveland Clinic and identified all pregnant patients with LQTS from January 2001 through January 2020. Collected data included use and timing of ß-blockers, maternal arrhythmic events, fetal growth restriction, neonatal hypoglycemia, and bradycardia. RESULTS: Among 68 live-birth pregnancies in 31 women with LQTS (mean age 29 ± 5.9 years; mean corrected QT interval 468 ± 39 ms), there were 5 arrhythmic events in 4 mothers. All arrhythmic events occurred in the postpartum period, and there were no arrhythmic events in patients taking ß-blockers. In patients diagnosed with LQTS and treated with ß-blockers (n = 27 [41%]), nadolol was the most commonly prescribed agent throughout pregnancy and the postpartum period (n = 16 [60%]). The rate of intrauterine growth restriction was not significantly different in fetuses exposed to ß-blockers vs unexposed (P = .08). In the postnatal period, hypoglycemia was not seen and 1 patient in the exposure group had bradycardia. CONCLUSION: Arrhythmic events were only seen in the postpartum period in those not treated with ß-blockers. Events occurred as late as 9 months postpartum. ß-Blocker therapy, specifically nadolol, was not associated with a higher incidence of intrauterine growth restriction. Moreover, neonatal bradycardia was rare and hypoglycemia was not observed.

Increasing Lesion Dimensions of Bipolar Ablation by Modulating the Surface Area of the Return Electrode.

OBJECTIVES: This study sought to examine the effect of the return electrode's surface area on bipolar RFA lesion size. BACKGROUND: Bipolar radiofrequency ablation (RFA) is typically performed between 2 3.5-mm tip catheters serving as active and return electrodes. We hypothesized that increasing the surface area of the return electrode would increase lesion dimensions by reducing the circuit impedance, thus increasing the current into a larger tissue volume enclosed between the electrodes. METHODS: In step 1, ex vivo bipolar RFA was performed between 3.5-mm and custom-made return electrodes with increasing surface areas (20, 80, 180 mm2). In step 2, ex vivo bipolar RFA was performed between 3.5-mm and 3.5-mm or 8-mm electrode catheters positioned perpendicular or parallel to the tissue. In step 3, in vivo bipolar RFA was performed between 3.5-mm and either 3.5-mm or 8-mm parallel electrode at the: 1) left ventricular summit; 2) interventricular septum; and 3) healed anterior infarction. RESULTS: In step 1, increasing the surface area of the return electrode resulted in lower circuit impedance (R = -0.65; P < 0.001), higher current (R = +0.80; P < 0.001), and larger lesion volume (R = +0.88; P < 0.001). In step 2, an 8-mm return electrode parallel to tissue produced larger and deeper lesions compared with a 3.5-mm return electrode (P = 0.014 and P = 0.02). Similarly, in step 3, compared with a 3.5-mm, bipolar RFA with an 8-mm return electrode produced larger (volume: 1,525 ± 871 mm3 vs 306 ± 310 mm3, respectively; P < 0.001) and more transmural lesions (88% vs 0%; P < 0.001). CONCLUSIONS: Bipolar RFA using an 8-mm return electrode positioned parallel to the tissue produces larger lesions in comparison with a 3.5-mm return electrode.

Preclinical safety and electrical performance of novel atrial leadless pacemaker with dual-helix fixation.

BACKGROUND: Complications associated with transvenous pacemakers, specifically those involving the lead or subcutaneous pocket, may be avoided with leadless pacemakers (LPs). The safety and efficacy of single-chamber right ventricular LPs have been demonstrated, but their right atrium (RA) use poses new design constraints. OBJECTIVES: The purpose of this study was to evaluate the implant success, electrical performance, and safety of a novel RA LP design in benchtop and preclinical studies. METHODS: A new LP was designed with a dual-helix fixation mechanism specific to the RA anatomy. A 12-week preclinical ovine study was conducted to evaluate implant success, electrical performance, mechanical stability, and safety in vivo, with supporting benchtop measurements to quantify the mechanical forces needed for device retrieval and dislodgment. RESULTS: LPs were successfully implanted in all 10 ovine subjects with no complications. The pacing capture threshold improved significantly over time from implant to week 12 (1.1 ± 0.7 V vs 0.4 ± 0.2 V, P = .008). Sensing amplitudes and pacing impedances were stable from implant to week 12 (4.8 ± 1.8 mV vs 6.0 ± 1.9 mV, P = .160; and 393 ± 77 Ω vs 398 ± 65 Ω, P = .922, respectively). Gross pathology and microscopic histology revealed no adverse interactions and no evidence of device dislodgment or clinically significant myocardial perforation. Benchtop ex vivo porcine atrial tissue measurements revealed greater pull forces required to dislodge the LP vs transvenous active fixation lead (0.42 ± 0.18 lbf vs 0.29 ± 0.08 lbf, P = .020), and greater rotational forces required for deliberate extraction (0.28 ± 0.04 lbf vs 0.14 ± 0.07 lbf, P <.001). CONCLUSION: The novel atrial LP demonstrated successful implantation, with acceptable electrical performance, mechanical stability, and safety in a 12-week preclinical study.

Cardiac resynchronisation therapy in anthracycline-induced cardiomyopathy.

INTRODUCTION: Chemotherapy-induced cardiomyopathy has been increasingly recognised as patients are living longer with more effective treatments for their malignancies. Anthracyclines are known to cause left ventricular (LV) dysfunction. While heart failure medications are frequently used, some patients may need consideration for device-based therapies such as cardiac resynchronisation therapy (CRT). However, the role of CRT in anthracycline-induced cardiomyopathy (AIC) is not well understood. METHODS: We performed a retrospective review of all patients undergoing CRT implantation at our centre from 2003 to 2019 with a diagnosis of AIC. The LV remodelling and survival outcomes of this population were obtained and then compared with consecutive patients with other aetiologies of non-ischaemic cardiomyopathy (NICM). RESULTS: A total of 34 patients underwent CRT implantation with a diagnosis of AIC with a mean age of 60.5±12.7 years, left ventricular ejection fraction (LVEF) of 21.7%±7.4%, and 11.3±7.5 years and 10.2±7.4 years from cancer diagnosis and last anthracycline exposure, respectively. At 9.6±8.1 months after CRT implantation, there was an increase of LVEF from 21.8%±7.6% to 30.4%±13.0% (p<0.001). Patients whose LVEF increased by at least 10% post-CRT implant (42.5% of cohort) survived significantly longer than patients who failed to improve their LVEF by that amount (p=0.01). A propensity matched analysis between patients with AIC and 369 consecutive patients with other aetiologies of NICM who underwent CRT implantation during the same period revealed no significant differences in improvement in LVEF or long-term survival. CONCLUSIONS: Patients with AIC undergo LV remodelling with CRT at rates similar to other aetiologies of NICM. Furthermore, AIC post-CRT responders have a favourable long-term mortality compared with non-responders.

Impact of High-Power Short-Duration Radiofrequency Ablation on Esophageal Temperature Dynamic.

BACKGROUND: High-power short-duration (HP-SD) radiofrequency ablation (RFA) has been proposed as a method for producing rapid and effective lesions for pulmonary vein isolation. The underlying hypothesis assumes an increased resistive heating phase and decreased conductive heating phase, potentially reducing the risk for esophageal thermal injury. The objective of this study was to compare the esophageal temperature dynamic profile between HP-SD and moderate-power moderate-duration (MP-MD) RFA ablation strategies. METHODS: In patients undergoing pulmonary vein isolation, RFA juxtaposed to the esophagus was delivered in an alternate sequence of HP-SD (50 W, 8-10 s) and MP-MD (25 W, 15-20 s) between adjacent applications (distance, ≤4 mm). Esophageal temperature was recorded using a multisensor probe (CIRCA S-CATH). Temperature data included magnitude of temperature rise, maximal temperature, time to maximal temperature, and time return to baseline. In swine, a similar experimental design compared the effect of HP-SD and MP-MD on patterns of esophageal injury. RESULTS: In 20 patients (68.9±5.8 years old; 60% persistent atrial fibrillation), 55 paired HP-SD and MP-MD applications were analyzed. The esophageal temperature dynamic profile was similar between HP-SD and MP-MD ablation strategies. Specifically, the magnitude of temperature rise (2.1 °C [1.4-3] versus 2.0 °C [1.5-3]; P=0.22), maximal temperature (38.4 °C [37.8-39.3] versus 38.5 °C [37.9-39.4]; P=0.17), time to maximal temperature (24.9±7.5 versus 26.3±6.8 s; P=0.1), and time of temperature to return to baseline (110±23.2 versus 111±25.1 s; P=0.86) were similar between HP-SD and MP-MD ablation strategies. In 6 swine, esophageal injury was qualitatively similar between HP-SD and MP-MD strategies. CONCLUSIONS: Esophageal temperature dynamics are similar between HP-SD and MP-MD RFA strategies and result in comparable esophageal tissue injury. Therefore, when using a HP-SD RFA strategy, the shorter application duration should not prompt shorter intervals between applications.

Assessment of primary prevention patients receiving an ICD - Systematic evaluation of ATP: APPRAISE ATP.

BACKGROUND: The value of antitachycardia pacing (ATP) in the overall cohort of primary prevention patients who receive implantable cardioverter-defibrillators (ICDs) remains uncertain. ATP success reported in prior trials potentially included a large number of patients receiving unnecessary ATP for arrhythmias that may have self-terminated owing to the prematurity of the intervention. Although some patients derive benefit from initial ATP in terminating rapid ventricular arrhythmias and thereby preventing shocks, there are limited data allowing us to identify those patients a priori. OBJECTIVE: The purpose of APPRAISE ATP is to understand the role of ATP in primary prevention patients currently indicated for ICD therapy in a large prospective randomized controlled trial with modern programming parameters. METHODS: The study is a global, prospective, randomized, multicenter clinical trial conducted at up to 150 sites globally, enrolling approximately 2600 subjects The primary endpoint of the trial is time to first all-cause shock in a 2-arm study with an equivalent study design in which the incidence of all-cause shocks will be compared between primary prevention subjects programmed with shocks only vs subjects programmed to standard therapy (ATP and shock). RESULTS: An Electrogram and Device Interrogation Core Laboratory will review interrogation data to determine primary endpoints that occur in APPRAISE ATP. Their decisions are based on independent physician review of the data from device interrogation. CONCLUSION: The ultimate purpose of the study is to aid clinicians in the selection of ICD technologies based on hard endpoint evidence across the spectrum of indications for primary prevention implantation.

Super and Nonresponders to Catheter Ablation for Atrial Fibrillation: A Quality-of-Life Assessment Using Patient Reported Outcomes.

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