EsophAguS Deviation During RadiofrequencY Ablation of Atrial Fibrillation: The EASY AF Trial.

BACKGROUND: Injury to the esophagus has been reported in a high percentage of patients undergoing ablation of atrial fibrillation (AF). OBJECTIVES: This study assessed the incidence of esophageal injury in patients undergoing ablation of AF with and without an esophageal deviating device. METHODS: This prospective, randomized, multicenter, double-blinded, controlled Food and Drug Administration investigational device exemption trial compared the incidence of ablation-related esophageal lesions, as assessed by endoscopy, in patients undergoing AF ablation assigned to a control group (luminal esophageal temperature [LET] monitoring alone) compared with patients randomized to a deviation group (esophagus deviation device + LET). This novel deviating device uses vacuum suction and mechanical deflection to deviate a segment of the esophagus, including the trailing edge. RESULTS: The data safety and monitoring board recommended stopping the study early after randomizing 120 patients due to deviating device efficacy. The primary study endpoint, ablation injury to the esophageal mucosa, was significantly less in the deviation group (5.7%) in comparison to the control group (35.4%; P < 0.0001). Control patients had a significantly higher severity and greater number of ablation lesions per patient. There was no adverse event assigned to the device. By multivariable analysis, the only feature associated with reduced esophageal lesions was randomization to deviating device (OR: 0.13; 95% CI: 0.04-0.46; P = 0.001). Among control subjects, there was no difference in esophageal lesions with high power/short duration (31.8%) vs other radiofrequency techniques (37.2%; P = 0.79). CONCLUSIONS: The use of an esophageal deviating device resulted in a significant reduction in ablation-related esophageal lesions without any adverse events.

Mortality post in-patient catheter ablation of atrial fibrillation in rural versus urban areas: Insights from national inpatient sample database.

BACKGROUND: A growing body of evidence is supportive of early atrial fibrillation (AF) ablation to maintain sinus rhythm. Disparities in health care between rural and urban areas in the United States are well known. Catheter ablation (CA) of AF is a complex procedure and its outcomes among rural versus urban areas has not been studied in the past. METHODS: The national inpatient sample database 2016-2020 was queried for all hospitalization with the primary diagnosis of AF who underwent AF catheter ablation at the index hospitalization. Then, hospitalizations were stratified into rural versus urban. The primary outcome was in-hospital mortality. Secondary outcomes were total hospitalization costs and likelihood for longer length of stay. RESULTS: A total of 78,735 patients underwent inpatient CA of AF between January 2016 and December 2020, mean age was 68.5 ± 11 with 44 % being females. 27,180 (35 %) CA were performed in rural areas, while the remaining CA  51,555 (65 %) were done in urban areas. While, there was very low risk of mortality, patients who underwent CA in rural areas had more comorbidities and also was associated with a 79 % increase in post-procedural in-hospital mortality compared with urban areas (aOR 1.79, 0.8 % vs 0.4 %, CI: 1.15-2.78, P < 0.01). CA of AF in rural areas had a longer length of hospital stay (aOR 1.11, 4.21 vs 3.79 days, 95 % CI: 1.02-1.2, P = 0.02), lower overall cost compared with urban areas (49,698 ± 1251 vs. $53,252 ± 1339, P = 0.03). Multivariate regression analysis showed end stage renal disease and congestive heart failure were independent risk factors associated with increase in post CA in-hospital mortality exceeding two-fold. CONCLUSION: Inpatient CA of AF in rural areas was associated with higher in-hospital mortality, longer length of stay and a lower overall cost when compared with urban areas.

Outcomes of Ventricular Tachycardia Catheter Ablation in Patients Who Underwent Cardiac Defibrillator Implantation Nationwide Readmission Database Analysis.

The timing of when to perform ventricular tachycardia (VT) ablation while receiving an implantable cardioverter defibrillator (ICD) during the same hospitalization has not been explored. This study aimed to investigate the use and outcomes of VT catheter ablation in patients with sustained VT receiving ICD in the same hospital stay. The Nationwide Readmission Database 2016 to 2019 was queried for all hospitalizations with a primary diagnosis of VT with subsequent ICD during the same admission. Hospitalizations were later stratified according to whether a VT ablation was performed. All catheter ablation of VT were performed before ICD implantation. The outcomes of interest were in-hospital mortality and 90-day readmission. A total of 29,385 VT hospitalizations were included. VT ablation was performed with subsequent ICD placement in 2,255 (7.6%), whereas 27,130 (92.3%) received an ICD only. No differences were found regarding in-hospital mortality (adjusted odds ratio [aOR] 0.83, 95% confidence interval [CI] 0.35 to 1.9, p = 0.67) and all-cause 90-day readmission rate (aOR 1.1, 95% CI 0.95 to 1.3, p = 0.16). An increase in readmission because of recurrent VT was noted in the VT ablation group (aOR 1.53, 8% vs 5% CI 1.2 to 1.9, p <0.01); the VT ablation group encompassed a higher number of patients with heart failure with reduced ejection fraction (p <0.01), cardiogenic shock (p <0.01), and mechanical circulatory support use (p <0.01). In conclusion, the use of VT ablation in patients admitted with sustained VT is low and reserved for higher risk patients with significant co-morbidities. Despite the higher risk profile of VT ablation cohort, no differences were found in the short-term mortality and readmission rate between the groups.

Low voltage area guided substrate modification in nonparoxysmal atrial fibrillation: A systematic review and meta-analysis.

BACKGROUND: Low voltage areas (LVAs) on left atrial (LA) bipolar voltage mapping correlate with areas of fibrosis. LVAs guided substrate modification was hypothesized to improve the success rate of atrial fibrillation (AF) ablation particularly in nonparoxysmal AF population. However, randomized controlled trials (RCTs) and observational studies yielded mixed results. METHODS: The databases of Pubmed, EMBASE and Cochrane Central databases were searched from inception to August 2022. Relevant studies comparing LVA guided substrate modification (LVA ablation) versus conventional AF ablation (non LVA ablation) in patients with nonparoxysmal AF were identified and a meta-analysis was performed (Graphical Abstract image). The efficacy endpoints of interest were recurrence of AF and the need for repeat ablation at 1-year. The safety endpoint of interest was adverse events for both groups. Procedure related endpoints included total procedure time and fluoroscopy time. RESULTS: A total of 11 studies with 1597 patients were included. A significant reduction in AF recurrence at 1-year was observed in LVA ablation versus non LVA ablation group (risk ratio [RR] 0.63 (27% vs. 36%),95% confidence interval [CI] 0.48-0.62, p < .001]. Also, redo ablation was significantly lower in LVA ablation group (RR 0.52[18% vs. 26.7%], 95% CI 0.38-0.69, p < .00133). No difference was found in the overall adverse event (RR 0.7 [4.3% vs. 5.4%], 95% CI 0.36-1.35, p = .29). CONCLUSION: LVA guided substrate modification provides significant reduction in recurrence of all atrial arrhythmias at 1-year compared with non LVA approaches in persistent and longstanding persistent AF population without increase in adverse events.

Role of Adjunctive Cryoballoon Left Atrial Posterior Wall Isolation in Non-paroxysmal Atrial Fibrillation: A Meta-analysis.

Progressive remodeling of left atrial posterior wall (LAPW) plays an important role in the pathology of persistent/ long-standing persistent atrial fibrillation. The role of pulmonary veins isolation (PVI) and adjunctive LAPW isolation using cryothermal energy in non-paroxysmal atrial fibrillation is yet to be established. The databases of Pubmed, EMBASE and Cochrane Central databases were searched from inception to April 2022. Relevant randomized trials and observational studies comparing de novo cryoballoon PVI only versus PVI+LAPWI in patients with non paroxysmal AF were identified and a meta-analysis was performed using the random effect model. The efficacy endpoints of interest were recurrence of AF, recurrence of non-AF and all atrial arrhythmias at 1-year post ablation. The safety endpoint of interest was all adverse events between the two groups. A total of 6 studies (3 prospective trials and 3 observational studies) with 1037 patients were included. A significant reduction in AF recurrence at 1-year was observed in PVI+LAPWI group (OR 0.36 (17% vs 39%), 95% CI 0.26-0.49, P < 0.001). Also, lower incidence of overall atrial arrhythmias was found in PVI+LAPWI (OR 0.37 (23% vs 47%),95% CI 0.28-0.49, P < 0.001). For safety endpoints, the overall adverse event rate was low without the significant difference between the groups (OR: 0.86, (3% vs 3.5%) 95% CI 0.36-2.07, P = 0.74). Cryoballoon LAPWI plus PVI provides a significant reduction in recurrence of all atrial arrhythmias and AF at 1-year compared with PVI alone in non paroxysmal AF population without increase in adverse events rate.

Unmasking Arrhythmogenic Hubs of Reentry Driving Persistent Atrial Fibrillation for Patient-Specific Treatment.

Background Atrial fibrillation (AF) driver mechanisms are obscured to clinical multielectrode mapping approaches that provide partial, surface-only visualization of unstable 3-dimensional atrial conduction. We hypothesized that transient modulation of refractoriness by pharmacologic challenge during multielectrode mapping improves visualization of hidden paths of reentrant AF drivers for targeted ablation. Methods and Results Pharmacologic challenge with adenosine was tested in ex vivo human hearts with a history of AF and cardiac diseases by multielectrode and high-resolution subsurface near-infrared optical mapping, integrated with 3-dimensional structural imaging and heart-specific computational simulations. Adenosine challenge was also studied on acutely terminated AF drivers in 10 patients with persistent AF. Ex vivo, adenosine stabilized reentrant driver paths within arrhythmogenic fibrotic hubs and improved visualization of reentrant paths, previously seen as focal or unstable breakthrough activation pattern, for targeted AF ablation. Computational simulations suggested that shortening of atrial refractoriness by adenosine may (1) improve driver stability by annihilating spatially unstable functional blocks and tightening reentrant circuits around fibrotic substrates, thus unmasking the common reentrant path; and (2) destabilize already stable reentrant drivers along fibrotic substrates by accelerating competing fibrillatory wavelets or secondary drivers. In patients with persistent AF, adenosine challenge unmasked hidden common reentry paths (9/15 AF drivers, 41±26% to 68±25% visualization), but worsened visualization of previously visible reentry paths (6/15, 74±14% to 34±12%). AF driver ablation led to acute termination of AF. Conclusions Our ex vivo to in vivo human translational study suggests that transiently altering atrial refractoriness can stabilize reentrant paths and unmask arrhythmogenic hubs to guide targeted AF driver ablation treatment.

Comprehensive strategies to minimize radiation exposure during Interventional electrophysiology procedures: state-of-the-art review.

INTRODUCTION: Cardiac electrophysiology (EP) procedures are frequently performed in patients with cardiac arrhythmias, chronic heart failure, and sudden cardiac death. Most EP procedures involve fluoroscopy, which results in radiation exposure to physicians, patients, and EP lab staff. Accumulated radiation exposure is a known health detriment to patients and physicians. AREA COVERED: This review will summarize radiation exposure, dose metrics, complications of radiation exposure, factors affecting radiation exposure, minimizing radiation exposure, zero or near-zero fluoroscopy strategies, and up-to-date research in the area of reducing radiation exposure and best practices. EXPERT COMMENTARY: Comprehensive strategies should be implemented in EP laboratories to minimize radiation exposure with standard fluoroscopy. There are routine techniques that can mitigate significant amounts of radiation exposure using standard equipment within the EP lab. The operators need to emphasize that EP practices routinely incorporate non-ionizing radiation sources for cardiac imaging (e.g. magnetic resonance imaging, advanced electroanatomical mapping systems, intracardiac ultrasonography) in addition to other novel technologies to mitigate radiation exposure to patients and physicians.

Feasibility and safety of same day subcutaneous defibrillator implantation and send home (DASH) strategy.

PURPOSE: To assess the feasibility and safety of same-day discharge after S-ICD implantation by implementing a specific analgesia protocol and phone follow-up. METHODS: Consecutive patients presenting for outpatient S-ICD implantation were enrolled between 1/1/2018 and 4/30/2019. An analgesia protocol included pre-operative acetaminophen and oxycodone, intraoperative local bupivacaine, and limited use of oxycodone-acetaminophen at discharge. The primary outcome was successful same-day discharge. Numerical Pain Rating Scale (NPRS) on postoperative day (POD) 1, 3, 14, and 30 and any unplanned health care visits during the 1-month follow-up period were assessed. RESULTS: Out of 53 potentially eligible S-ICD patients, 49 patients (92.5%) were enrolled and successfully discharged on the same day. Mean age of these 49 patients was 47 ± 14 years. There were no acute procedural complications. Severe pain (NPRS ≥ 8) on POD 0, 1, and 3 was present in 14.3%, 14.3%, and 8.2% of patients, respectively. The total in-hospital stay was 534 ± 80 min. Four unplanned visits (8%) due to cardiac or device-related issues occurred during 1-month follow-up, including 2 patients with heart failure exacerbation, one patient with an incisional infection, and one patient with inappropriate shocks. CONCLUSIONS: With the appropriate institutional protocol including specific analgesics and phone follow-up, same-day discharge after outpatient S-ICD implantation is feasible and appears safe for most patients.. Device-related pain can be severe in the first 3 days post-implantation and can be successfully treated with limited supply of narcotic medications.

Adenosine triphosphate/adenosine guided pulmonary vein isolation does not improve the outcomes of ablation: a meta-analysis of randomized controlled trials.

BACKGROUND: Successful pulmonary vein isolation (PVI) is the most reliable predictor of success after ablation in patients with atrial fibrillation (AF). Adenosine triphosphate (ATP) unmasks the dormant conduction and can be used to improve the effectiveness of PVI. The impact of ATP guided PVI on clinical outcomes is discordant in various randomized controlled trials (RCTs). OBJECTIVES: To delineate the incremental benefit of ATP during PVI in patients with AF through a meta-analysis. METHODS AND RESULTS: Database searches through January 2017 identified 5 RCTs (enrolling 2839 patients) comparing ATP guided PVI versus standard PVI (non-ATP). Four trials exclusively studied paroxysmal AF while one trial included both paroxysmal and non-paroxysmal AF patients. Baseline characteristics, dose of adenosine and ablation strategies were clearly identified among all the trials. The risk ratio (RR) for AF episodes lasting >30 s after 3-month blanking period was calculated with random effects meta-analysis and showed no difference at a median follow up of 12 months [RR: 1.02, 95 % Confidence interval (CI): 0.85 to 1.25; p = 0.82]. Similarly, the number of repeat ablation was similar in both groups [RR: 1.02, 95 % CI: 0.63, 1.56; p = 0.98]. CONCLUSIONS: ATP guided PVI does not decrease the recurrence of AF or the need for repeat ablation at 12 months.

Position of Subcutaneous Implantable Cardioverter-Defibrillators and Possible Interference on Myocardial Perfusion Imaging.

Implanted cardioverter-defibrillators can prevent sudden cardiac death in at-risk patients. In comparison with conventional transvenous systems, entirely subcutaneous implantable cardioverter-defibrillators have produced similar reductions in the rate of sudden cardiac death but with fewer sequelae. An infrequently reported drawback of subcutaneous devices, however, is the potential for generating attenuation artifact during nuclear myocardial perfusion imaging. We had concerns about potential attenuation artifact in a 65-year-old man with coronary artery disease but found that having positioned the pulse generator in the midaxillary zone avoided problems.

Factors Determining Left Main Coronary Artery Luminal Area.

BACKGROUND: A certain minimal luminal cross-sectional area has been traditionally used in clinical practice as a cut-off value to determine severity of left main coronary artery (LMCA) stenosis. The severity of stenosis, however, depends on the baseline luminal area (ie, area prior to stenosis), which may vary among individuals. The present study was undertaken to define normal LMCA luminal area using current technology in vivo. METHODS: LMCA luminal area was determined using multislice computed tomography coronary angiography. Eighty-six subjects with normal coronary arteries and calcium score of zero were included in this study. Left ventricular (LV) mass and LV volumes (systolic, diastolic) were also measured. RESULTS: A wide distribution was found in LMCA luminal area, with median value 17.3 mm² and range 8.1-33.9 mm². A relationship was found between log(LMCA luminal area) and log(LV mass) (r=.515; P<.001) and with body surface area (r=.273; P=.01). Significant relationships were also found between LMCA luminal area and LV volumes (systolic, diastolic). In multiple regression analysis, however, the LV mass was the only independent predictor of LMCA luminal area. CONCLUSION: LMCA luminal area varies substantially among individuals with normal coronary arteries and is related to many other factors. The data suggest that the current practice of using a minimal luminal area cut-off when assessing LMCA stenosis may be misleading, and thus available information should be individualized.

Multiple Small Coronary Artery Fistulas Emptying into the Left Ventricle: A Rare but Challenging Problem.

A coronary artery fistula (CAF) is an abnormal communication between a coronary artery and a cardiac chamber or a great vessel. CAFs are rare based on coronary arteriography and when found they most often empty into the right ventricle and atrium and less often into the high pressure, low compliance left ventricle (LV). A patient who presented with atypical chest pain and was found to have multiple small CAFs originating from the ramus intermedius coronary artery and emptying into the LV is presented. This case highlights the challenges in providing an appropriate therapy for multiple small CAFs emptying into the LV.