Bunch, T. Jared

BACKGROUND: Catheter ablation of ventricular arrhythmias, one of the most rapidly growing procedures in cardiac electrophysiology, is associated with magnetic resonance imaging–detected brain lesions in more than half of cases. Although a retrograde aortic approach is conventional, modern tools enable entry through a transseptal approach that may avoid embolization of debris from the arterial system. We sought to test the hypothesis that a transseptal puncture would mitigate brain injury compared with a retrograde aortic approach. METHODS: The TRAVERSE trial (Transseptal Versus Retrograde Aortic Ventricular Entry to Reduce Systemic Emboli) was a multicenter randomized controlled comparative effectiveness trial. Patients with left ventricular arrhythmias undergoing catheter ablation procedures were randomly assigned to a transseptal puncture approach compared (1:1) with a retrograde aortic approach. The primary outcome was the presence of an acute brain lesion detected by magnetic resonance imaging. Secondary outcomes included clinically manifest complications, procedural efficacy, and 6-month neurocognitive assessments. RESULTS: Among the 62 patients randomly assigned to a retrograde aortic approach with postoperative brain magnetic resonance imaging, 28 (45%) exhibited an acute brain lesion compared with 19 of the 69 (28%) of those randomized to a transseptal puncture ( P =0.036). No differences in clinically manifest complications or procedural efficacy were observed. More patients in the retrograde aortic arm were categorized as having a high likelihood of cognitive impairment at 6 months (33% compared with 19% of those in the transseptal arm), but substantial loss to follow-up was present. CONCLUSIONS: Among patients undergoing left ventricular catheter ablation procedures, a transseptal approach reduced the risk of acute brain lesions by nearly half compared with a retrograde aortic approach without sacrificing safety or efficacy. Given a likely embolic pathogenesis, the brain magnetic resonance imaging findings may reflect a propensity to other organ damage; these findings may extend to other procedures requiring left ventricular entry. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03946072.

Introduction: Pulsed field ablation (PFA) is an adaptation of direct current ablation first used for catheter ablation in the 1980s. Expectations of a reduced risk profile led to the current resurgence in investment and interest in the technology as a potential alternative energy source for ablations to treat atrial fibrillation (AF). However, reports of adverse events, including new risks, are increasing. Research Question: How many adverse effects are reported with the use of newly available PFA systems? Aims: Quantify and describe the adverse events from PFA reported to date in the Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Methods: We searched the U.S. FDA’s MAUDE database for all reports filed with the code “QZI”, which is the product code for PFA systems created with the first FDA approvals in February 2024. All reports from inception through April 2024 (a total of 3 months) were included in this review. Per manufacturer presentation in May 2024, approximately 1000 cases utilizing PFA had been captured in a post-market registry of the predominant commercially used technology, but the exact number of cases can not be determined from MAUDE data. Results: A total of 217 adverse events were reported over the first 3 months of US approval, with 91 of these considered patient injuries. These injuries included 10 cases of cardiac tamponade, 7 reports of postoperative arrhythmia, 6 instances of device-related tissue entrapment, 5 cases of hemolysis with impaired renal function, 5 cases of stroke or TIA, including both embolic and hemorrhagic, 3 cases of intraoperative heart block, 2 coronary spasms, and 2 cases of intraoperative ST elevation. (Figure) Of the 91 reported patient safety events, 46 required hospitalization, 13 cases required temporary pacing, 11 required pericardiocentesis, 4 required dialysis, 4 required cardiothoracic surgery, and 2 required cardioversion. Conclusions: A number of adverse events have been reported to the MAUDE database in the first 3 months of FDA approval of PFA. The cardiac electrophysiology community should remain vigilant to ensure that the benefit-risk profile remains acceptable for patient safety.

AbstractIntroductionDirect oral anticoagulants (DOACs) become the recommended treatment over vitamin K antagonists (VKA) in patients with non‐valvular atrial fibrillation (AF). However, their effectiveness in reducing cognitive impairment and dementia compared to VKA remains unclear.MethodsA systematic literature search was conducted on Ovid MEDLINE, EMBASE, and Cochrane Database. Randomized controlled trials, cohort, or case–control study that assessed incident dementia between AF patients who received DOAC compared to VKA were selected. Relevant study characteristics and the number of incident dementia diagnosis or hazard ratios (HRs) for incident dementia and each dementia subtypes were extracted. Random‐effects model was used to perform meta‐analysis. Standardized mean differences (SMDs) were used to estimate effect sizes for continuous data.ResultsTwelve cohort studies comprising 1 451 069 individuals were included. The incidence of dementia was lower in AF patients prescribed DOACs compared to VKA (HR 0.88, 95% CI 0.83–0.93, I 2 = 61.2%). A lower incident dementia in DOACs group relative to VKA was significantly observed in those less than 75 years of age (< 65 years, HR 0.83 (95% CI 0.72–0.97, I 2 = 0%); 65–74 years, HR 0.86 (95% CI 0.81–0.92, I 2 = 55.4%); and ≥ 75 years, HR 1.07 (95% CI 0.74–1.55, I 2 = 92.5%)) and for the subgroup of patients with vascular dementia (HR 0.91, 95% CI 0.824–0.997, I 2 = 0%).ConclusionsThis meta‐analysis reveals a reduction in incidence of dementia in AF patients prescribed DOACs compared to VKA, particularly in those less than 75 years old and in the vascular dementia subtype.

AbstractBackgroundHigh‐power short‐duration (HPSD) atrial fibrillation (AF) ablation with a power of 40–50 W was proved to be safe and effective. Very high‐power short‐duration (vHPSD) AF ablation is a novel method using >50 W to obtain more durable AF ablation. This study aimed to evaluate the efficacy and safety of vHPSD ablation compared with HPSD ablation and conventional power ablation.MethodsA literature search for studies that reported AF ablation outcomes, including short‐term freedom from atrial arrhythmia, first‐pass isolation (FPI) rate, procedure time, and major complications, was conducted utilizing MEDLINE, EMBASE, and Cochrane databases. All relevant studies were included in this analysis. A random‐effects model of network meta‐analysis and surface under cumulative ranking curve (SUCRA) were used to rank the treatment for all outcomes.ResultsA total of 29 studies with 9721 patients were included in the analysis. According to the SUCRA analysis, HPSD ablation had the highest probability of maintaining sinus rhythm. Point estimation showed an odds ratio of 1.5 (95% confidence interval [CI]: 1.2–1.9) between HPSD ablation and conventional power ablation and an odds ratio of 1.3 (95% CI: 0.78–2.2) between vHPSD ablation and conventional power ablation. While the odds ratio of FPI between HPSD ablation and conventional power ablation was 3.6 (95% CI: 1.5–8.9), the odds ratio between vHPSD ablation and conventional power ablation was 2.2 (95% CI: 0.61–8.6). The procedure times of vHPSD and HPSD ablations were comparable and, therefore, shorter than that of conventional power ablation. Major complications were low in all techniques.ConclusionvHPSD ablation did not yield higher efficacy than HPSD ablation and conventional power ablation. With the safety concern, vHPSD ablation outcomes were comparable with those of other techniques.

AbstractIntroductionAtrial fibrillation (AF) ablation is increasingly performed worldwide. As comfort with AF ablation increases, the procedure is increasingly used in patients that are older and in those with more comorbidities. However, it is not well established whether AF ablation in the elderly, especially those >75 years old, has comparable safety and efficacy to younger populations.ObjectiveTo compare the efficacy and safety profiles in patients older than 75 years undergoing AF ablation with younger patients.MethodsDatabases from EMBASE, Medline, PubMed, and Cochrane, were searched from inception through September 2021. Studies that compared the success rates in AF catheter ablation and all complications rates between patients who were older vs under 75 years were included. Effect estimates from the individual studies were extracted and combined using random effect, generic inverse variance method of DerSimonian and Laird.ResultsTwenty‐seven observational studies were included in the analysis consisting of 363,542 patients who underwent AF ablation. Comparing patients older than 75 years old to younger patients, there was no difference in the success of ablation rates between elderly and younger patients (pooled OR 0.85: 95% CI:0.69–1.05, p = .131). On the other hand, AF ablation in the elderly was associated with higher complication rates (pooled OR 1.42: 95% CI:1.21–1.68, p < .001).ConclusionAs AF ablation is expanded to elderly populations, our study found that AF ablation success rates were similar in both elderly and younger patients. However, older patients experience higher rates of complications that should be considered when offering the procedure and as a means to improve outcomes with future innovations.

Abstract Aims Influence of atrial fibrillation (AF) type on outcomes seen with catheter ablation vs. drug therapy is incompletely understood. This study assesses the impact of AF type on treatment outcomes in the Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA). Methods and results CABANA randomized 2204 patients ≥65 years old or &lt;65 with at least one risk factor for stroke to catheter ablation or drug therapy. Of these, 946 (42.9%) had paroxysmal AF (PAF), 1042 (47.3%) had persistent AF (PersAF), and 215 (9.8%) had long-standing persistent AF (LSPAF) at baseline. The primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Symptoms were measured with the Mayo AF-Specific Symptom Inventory (MAFSI), and quality of life was measured with the Atrial Fibrillation Effect on Quality of Life (AFEQT). Comparisons are reported by intention to treat. Compared with drug therapy alone, catheter ablation produced a 19% relative risk reduction in the primary endpoint for PAF {adjusted hazard ratio [aHR]: 0.81 [95% confidence interval (CI): 0.50, 1.30]}, and a 17% relative reduction for PersAF (aHR: 0.83, 95% CI: 0.56, 1.22). For LSPAF, the ablation relative effect was a 7% reduction (aHR: 0.93, 95% CI: 0.36, 2.44). Ablation was more effective than drug therapy at reducing first AF recurrence in all AF types: by 51% for PAF (aHR: 0.49, 95% CI: 0.39, 0.62), by 47% for PersAF (aHR: 0.53, 95% CI: 0.43,0.65), and by 36% for LSPAF (aHR 0.64, 95% CI 0.41,1.00). Ablation was associated with greater improvement in symptoms, with the mean difference between groups in the MAFSI frequency score favouring ablation over 5 years of follow-up in all subgroups: PAF had a clinically significant −1.9-point difference (95% CI: −1.2 to −2.6); PersAF a −0.9 difference (95% CI: −0.2 to −1.6); LSPAF a clinically significant difference of −1.6 points (95% CI: −0.1 to −3.1). Ablation was also associated with greater improvement in quality of life in all subgroups, with the AFEQT overall score in PAF patients showing a clinically significant 5.3-point improvement (95% CI: 3.3 to 7.3) over drug therapy alone over 5 years of follow-up, PersAF a 1.7-point difference (95% CI: 0.0 to 3.7), and LSPAF a 3.1-point difference (95% CI: -1.6 to 7.8). Conclusion Prognostic treatment effects of catheter ablation compared with drug therapy on the primary and major secondary clinical endpoints did not differ consequentially by AF subtype. With regard to decreases in AF recurrence and improving quality of life, ablation was more effective than drug therapy in all three AF type subgroups. ClinicalTrials.gov Identifier NCT00911508

AbstractBackgroundRadiofrequency catheter ablation for cardiac arrhythmias has traditionally been guided by fluoroscopy. Fluoroscopy exposes the patient, operator, and staff to ionizing radiation which has no safe dose void of stochastic and deterministic biologic risks. Zero fluoroscopy (ZF) approaches for catheter ablation have been advocated to eliminate these risks. We conducted a meta‐analysis comparing acute procedure success, recurrence‐free survival, complications, and procedure times between the approaches.MethodsWe conducted a literature search from inception through December 2020 in the databases of EMBASE and MEDLINE. We included randomized controlled trials and cohorts that compared the outcomes of interest in ZF and conventional/low fluoroscopy (CF/LF) approaches. The outcomes sought were acute procedure success, recurrence‐free survival, complications, and procedure times. Effect estimates were combined, using the random‐effects, generic inverse variance method of DerSimonian and Laird.ResultsSixteen studies from 2013 to 2020, including 6052 patients (2219 ZF, 3833 CF/LF) were included. There were no significant differences in acute procedure success rate (odds ratio [OR]: 1.10, 95% confidence interval [CI]: 0.75–1.59), recurrence‐free survival (OR: 1.08, 95% CI: 0.78–1.49), periprocedural complication rate (OR: 0.72, 95% CI: 0.45–1.16), or total procedure time (weighted mean difference 2.32 min, 95% CI: −2.85–7.50) between ZF and CF/LF approaches, respectively. Overall, only 1.26% of patients crossed over from ZF to CF/LF arm.ConclusionsPeriprocedural and postprocedural outcomes with a ZF approach compared favorably with traditional fluoroscopic guidance without increasing procedural times. As comfort with ZF grows, coupled with evolving mapping technologies, this method has potential to become the standard approach for catheter ablation.

Background : Studies have shown an association between obesity and total mortality in patients with and without coronary artery disease. Less is known regarding the impact of obesity after cardiac arrest. Obese survivors of ventricular fibrillation (VF) out-of-hospital cardiac arrest (OHCA) may have worse outcomes than nonobese patients due to resuscitation challenges, long-term risks of cardiovascular disease, and other comorbidities. Methods : All patients who presented with a VF OHCA in Rochester Minnesota from November 1990-September 2006 were included. Patients were classified by weight (BMI <25, 25–30, >30). ICD shocks for VF/VT were determined by review of subsequent device interrogations. Results : 226 patients (age 63.7±13.5) were treated for VF OHCA with an average call-to-shock time of 6.3±1.8 minutes. 99 patients (44%) survived to hospital discharge with neurologic recovery. Data to calculate BMI were available in 213(95%). There was no difference between the relative distribution of body weight between the hospital survivors [<25(32%), 25–30(37%), >30(31%)] and nonsurvivors [<25(32%), 25–30(44%), >30(28%)], p=0.711. There was no difference in ICD implantation rates between weight groups (p=0.251). The patients were followed for an average of 5.8±4.4 years. The 5-year survival was 80±5%. 5-year survival was lower in underweight/normal patients [<25, 71% (63–79) compared to heavier patients (25–30:88% (82–94), p=0.001]. The survival difference persisted after adjustment for age (p=0.02). Malignancy was the most common cause of death in the underweight group. The 5-year survival free of ICD shocks was 61±7% with no weight-based difference in shocks. Conclusion : There was no apparent weight-based influence on resuscitation survival after VF OHCA. Patients who are under to normal weight had a lower long-term survival and represent a high-risk population primarily due to noncardiac diseases.

Background. ICD implantation for primary prevention of sudden death in patients with ischemic cardiomyopathy and left ventricular dysfunction is well established. However debate exists between the relationship between ischemia and the proarrhythmic state. Persistent ischemia may counter antiarrhythmic (AA) drug and/or device efficacy. Furthermore, the extent to which revascularization mitigates this influence of ischemia on efficacy is unknown. Methods . 704 patients enrolled in the MUSTT trial were studied. Ischemia was determined by the presence of angina within 6 weeks of enrollment and ≥ 2 reversible thallium defects. Revascularization was characterized as CABG or PTCA within 1 year of enrollment or the use of thrombolytics with the sentinal myocardial infarction (MI). We compared groups who were randomized to background medical treatment (BG Rx) verses those who were randomized to AA drug therapy in addition to EP testing (EP AARx). Results . 507 (81%) patients had ≤2 vessel CAD, whereas the remaining 19% had 3 vessel disease. 268 patients reported angina within 6 weeks of study enrollment. Thallium imaging revealed 0–1 defects in 458 (65%) and ≥2 in another 246 (35%). Those with ≥ 2 defects on Thallium and angina within 6 weeks of device implant had a significantly lower 5-year freedom from mortality in the EP AARx and BG Rx cohorts (Table ). Patients with EP AARx had an 8% lower mortality than those with BG Rx therapy alone if they received thrombolytics. However, if they did not receive thrombolytics, their mortality rate was 5% higher than the BG Rx group. Conclusion . Outcomes are worse in patients on antiarrhythmic therapy with ischemic factors compared to those on background therapy alone, particularly in the setting of recent angina. A proarrhythmic effect from antiarrhythmic drug therapy in patients with ischemia may underlie the higher mortality. ICD therapy mitigates the negative long-term effect of ischemia on mortality in those treated with AA therapy. Five Year Freedom from Mortality

Background : Lipid lowering therapy reduces mortality in patients with both ischemic and nonischemic cardiomyopathies and recently has been shown to decrease ICD shocks. Radiofrequency ablation (RFA) of recurrent VT in patients with an ICD also reduces shocks following intervention. It is unclear if statin therapy after VT RFA will further impact ICD shock rates. Methods : All patients from 1993–2005 who underwent a RFA procedure for recurrent VT at the Mayo Clinic with an ICD were included. Patient records were extracted for medical and procedural details and all ICD interrogations were reviewed for VT recurrence and therapies. Results: 63 patients (age 62±15 years) were followed over 3.9±3.6 years. Comorbid diseases included: coronary artery disease 37(58%, 34 prior myocardial infarction), ARVD/C 6(10%), nonischemic dilated cardiomyopathy 7(11%), moderate-severe valve disease 14(22%), hypertension 34(54%), and hyperlipidemia 35(56%). Ejection fraction was <0.35 in 34(56%). VT was induced in all patients (LV 55 (LVOT 1), RV 8 (RVOT 3) with multiple inducible VTs in 21(33%). VT was noninducible after RFA in 39(62%) patients. Dismissal medications included: statins 19(30%), beta blockers 40(66%), ACE/ARB 37(61%), diuretics 34(55%), and digoxin 23(37%). 5-year overall survival was 63%(95% CI 55–71). Age, diabetes, and renal insufficiency were associated with increased post ablation mortality, with no medication improving survival. 5-year survival free of ICD shocks was 31%(95% CI 24–38). Only statin therapy at discharge was associated with a decreased risk of ICD shocks [5(26%) versus 26(59%), p=0.020]. 7 additional patients received statins during follow-up, but not at discharge, of these 5(71%) had shocks. Conclusion : Statin use at discharge in patients with an ICD undergoing RFA for refractory VT significantly reduced recurrent ventricular arrhythmias and ICD shocks. Although the mechanism underlying the effects of statins on arrhythmic recurrence early after RFA requires further study, these data support aggressive therapy of the underlying substrate responsible for the VT.