Real-world data of radiofrequency catheter ablation in paroxysmal atrial fibrillation: Short- and long-term clinical outcomes from the prospective multicenter REAL-AF Registry.

BACKGROUND: The safety and long-term efficacy of radiofrequency (RF) catheter ablation (CA) of paroxysmal atrial fibrillation (PAF) has been well established. Contemporary techniques to optimize ablation delivery, reduce fluoroscopy use, and improve clinical outcomes have been developed. OBJECTIVE: The purpose of this study was to assess the contemporary real-world practice approach and short and long-term outcomes of RF CA for PAF through a prospective multicenter registry. METHODS: Using the REAL-AF (Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation; ClincalTrials.gov Identifier: NCT04088071) Registry, patients undergoing RF CA to treat PAF across 42 high-volume institutions and 79 experienced operators were evaluated. The procedures were performed using zero or reduced fluoroscopy, contact force sensing catheters, wide area circumferential ablation, and ablation index as a guide with a target of 380-420 for posterior and 500-550 for anterior lesions. The primary efficacy outcome was freedom from all-atrial arrhythmia recurrence at 12 months. RESULTS: A total of 2470 patients undergoing CA from January 2018 to December 2022 were included. Mean age was 65.2 ±11.14 years, and 44% were female. Most procedures were performed without fluoroscopy (71.5%), with average procedural and total RF times of 95.4 ± 41.7 minutes and 22.1±11.8 minutes, respectively. At 1-year follow-up, freedom from all-atrial arrhythmias was 81.6% with 89.7% of these patients off antiarrhythmic drugs. No significant difference was identified comparing pulmonary vein isolation vs pulmonary vein isolation plus ablation approaches. The complication rate was 1.9%. CONCLUSION: Refinement of RF CA to treat PAF using contemporary tools, standardized protocols, and electrophysiology laboratory workflows resulted in excellent short- and long-term clinical outcomes.

Practice Patterns of Operators Participating in the Real-World Experience of Catheter Ablation for Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation (REAL-AF) Registry.

BACKGROUND: The Real-World Experience of Catheter Ablation for Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation (REAL-AF) is a multicenter prospective registry of atrial fibrillation (AF) ablation. We sought to describe the baseline workflows of REAL-AF operators. METHODS: REAL-AF enrolls high volume minimum fluoroscopy radiofrequency ablators. A 150 item questionnaire was administered to participating operators. Responses were analyzed using standard methods. RESULTS: Forty-two respondents had a mean 178.2 ± 89.2 yearly AF ablations, with 42.4 ± 11.9% being paroxysmal (PAF). Most operators performed ablation with uninterrupted or minimally interrupted anticoagulation (66.7% and 28.6%). Left atrial appendage (LAA) thrombus was most commonly ruled out with transesophageal echocardiography (33.3% and 42.9% for PAF and persistent AF). Consistent with registry design, radiofrequency energy (92.1% ± 18.8% of cases) and zero fluoroscopy ablation (73.8% goal 0 fluoroscopy) were common. The majority of operators relied on index-guided ablation (90.5%); Mean Visitag surpoint targets were higher anteriorly vs posteriorly (508.3 ± 49.8 vs 392.3 ± 37.0, p < 0.01), but power was similar. There was considerable heterogeneity related to gaps in current knowledge, such as lesion delivery targets and sites of extra-pulmonary vein ablation (most common was the posterior wall followed by the roof). Peri-procedural risk factor management of obesity, hypertension, and sleep apnea was common. There was a mean of 3.0 ± 1.2 follow-up visits at 12 months. CONCLUSIONS: REAL-AF operators were high volume low fluoroscopy "real world" operators with good follow-up and adherence to known best-practices. There was disagreement related to knowledge gaps in guidelines.

A prospective multi-site registry of real-world experience of catheter ablation for treatment of symptomatic paroxysmal and persistent atrial fibrillation (Real-AF): design and objectives.

PURPOSE: Catheter ablation has become a mainstay therapy for atrial fibrillation (AF) with rapid innovation over the past decade. Variability in ablation techniques may impact efficiency, safety, and efficacy; and the ideal strategy is unknown. Real-world evidence assessing the impact of procedural variations across multiple operators may provide insight into these questions. The Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation registry (Real-AF) is a multicenter prospective registry that will enroll patients at high volume centers, including academic institutions and private practices, with operators performing ablations primarily with low fluoroscopy when possible. The study will also evaluate the contribution of advent in technologies and workflows to real-world clinical outcomes. METHODS: Patients presenting at participating centers are screened for enrollment. Data are collected at the time of procedure, 10-12 weeks, and 12 months post procedure and include patient and detailed procedural characteristics, with short and long-term outcomes. Arrhythmia recurrences are monitored through standard of care practice which includes continuous rhythm monitoring at 6 and 12 months, event monitors as needed for routine care or symptoms suggestive of recurrence, EKG performed at every visit, and interrogation of implanted device or ILR when applicable. RESULTS: Enrollment began in January 2018 with a single site. Additional sites began enrollment in October 2019. Through May 2021, 1,243 patients underwent 1,269 procedures at 13 institutions. Our goal is to enroll 4000 patients. DISCUSSION: Real-AF's multiple data sources and detailed procedural information, emphasis on high volume operators, inclusion of low fluoroscopy operators, and use of rigorous standardized follow-up methodology allow systematic documentation of clinical outcomes associated with changes in ablation workflow and technologies over time. Timely data sharing may enable real-time quality improvements in patient care and delivery. Trial registration Clinicaltrials.gov: NCT04088071 (registration date: September 12, 2019).

Outcomes of lead extraction without subsequent device reimplantation.

AIMS: Outcomes among patients who do not receive device reimplantation after cardiovascular implantable electronic device (CIED) extraction have not been well studied. The present study aims to investigate the outcomes of patients without device reimplantation after lead extraction and device removal. METHODS AND RESULTS: We retrospectively searched for consecutive patients who underwent CIED extraction at Mayo Clinic, Rochester, MN and University of California San Diego Medical Center from 2001 through 2012. Among the patients identified, we compared characteristics of those who did and did not have device reimplantation. The Kaplan-Meier survival was analysed. Among 678 patients, 97 patients had their device extracted without reimplantation during 1-year follow-up ('no-reimplant group'). Median age was younger in the no-reimplant group (60.7 vs. 70.6 years; P < 0.001). The reasons for no reimplantation were as follows: no longer meeting criteria for CIED (48%), inappropriate device indication at initial implantation (23%), patient preference (17%), and unresolved device complications (12%). Three major arrhythmias were reported in the no-reimplant group. Overall survival in the no-reimplant group was significantly lower than in the reimplant group (60 vs. 93%; P < 0.001). Ongoing device-related complications [hazard ratio (HR), 3.91; 95% CI, 1.74-8.81; P = 0.001], infection (HR, 3.06; 95% CI, 1.24-7.52; P = 0.02), and concurrent dialysis (HR, 2.74; 95% CI, 1.12-6.71; P = 0.03) were associated with increased mortality. Of 31 deaths in the no-reimplant group, 1 was secondary to cardiac arrhythmia. CONCLUSION: Fourteen per cent of patients who had device extraction did not undergo reimplantation mainly because they no longer met CIED indications. The high mortality in these patients is related to device complications and comorbid conditions, whereas mortality associated with arrhythmia is rare.

Compatibility of Radiofrequency Surgical Sponge Detection Technology with Cardiac Implantable Electronic Devices and Temporary Pacemakers.

BACKGROUND: Radiofrequency (RF) technology has improved detection of retained surgical sponges with a reported 100% sensitivity and specificity. However, the potential for interactions of the RF signals emitted by the detection system with cardiac implantable electronic devices (CIEDs) or temporary pacemakers may limit its use in those patients with these devices. This study investigated whether RF detection technology causes interference or clinically significant changes in the programmed settings of implanted pacemakers and defibrillators or temporary epicardial pacemakers. METHODS: Fifty patients who were scheduled either for CIED removal or placement of a temporary epicardial pacemaker (at the time of open heart surgery) were recruited for this study. Device settings and measurements from separate interrogations before and after scanning with the RF detection system were compared. For the temporary pacemakers, we observed for any changes in hemodynamics or signs of pacing interference. RESULTS: Twenty (40%) pacemakers, 20 (40%) implantable cardioverter defibrillators, and 10 (20%) temporary pacemakers were analyzed in this study. During scanning, no signal interference was detected in any permanent device, and there were no significant changes in programmed settings after scanning with the RF detection system. However, pacing inhibition was detected with temporary pacing systems when programmed to a synchronous mode (DDD). CONCLUSIONS: RF detection technology can be safely used to scan for retained surgical sponges in patients with permanent CIEDs and temporary pacemakers set to asynchronous mode.

Cardiac Device Implant Skin Closure with a Novel Adjustable, Coaptive Tape-Based Device.

BACKGROUND: The purpose of this study was to compare a unique zip-type adjustable coaptive tape-based skin closure device to traditional subcuticular sutures in three domains: time, cosmesis, and wound closure-related outcomes in cardiac implantable electronic device (CIED) procedures. METHODS: A total of 40 patients were enrolled in a prospective randomized controlled trial to assess time to wound closure, as well as cosmesis and wound closure-related outcomes. RESULTS: The adjustable coaptive tape-based skin closure device had shorter overall closure time (78 ± 6.6 seconds vs 216 ± 21.5 seconds; P < 0.001) and mean closure time per centimeter (18.0 ± 2.0 s/cm vs 50.1 ± 6.7 s/cm; P < 0.001) versus sutures, with less intersurgeon and interpatient variability with the use of adjustable coaptive device versus sutures (P < 0.001). There was no difference between groups in postoperative pain or scar cosmesis during the follow-up period. Neither group had any closure-related adverse events. CONCLUSIONS: The adjustable coaptive tape-based skin closure device demonstrated shorter closure times with less variability when compared to sutures. It is a safe and acceptable alternative to sutures for skin closure following CIED implantation.

Mechanisms Underlying AF: Triggers, Rotors, Other?

OPINION STATEMENT: There is ongoing debate regarding the precise mechanisms underlying atrial fibrillation (AF). An improved understanding of these mechanisms is urgently needed to improve interventional strategies to suppress and eliminate AF, since the success of current strategies is suboptimal. At present, guidelines for AF ablation focus on pulmonary vein (PV) isolation for the prevention of arrhythmia. Additional targets are presently unclear, and include additional linear ablation and electrogram-guided substrate modification, without clear mechanistic relevance. PV and non-PV triggers are likely central in the first few seconds of AF initiation. Rapid activation from such triggers interacts with transitional mechanisms including conduction velocity slowing, action potential duration (APD) alternans, and steep APD restitution to cause conduction block and initiate functional reentry. However, complete suppression of potential triggers has proven elusive, and the intra-procedural mapping and targeting of transitional mechanisms has not been reported. A growing body of research implicates electrical rotors and focal sources as central mechanisms for the maintenance of AF. In several recent series, they were observed in nearly all patients with sustained arrhythmia. Ablation of rotor and focal source sites, prior to pulmonary vein isolation, substantially modulated atrial fibrillation in a high proportion of patients, and improved ablation outcomes versus pulmonary vein isolation alone. These results have subsequently been confirmed in multicenter series, and the improved outcomes have been found to persist to a mean follow-up of 3 years. Recently, rotors have been observed by multiple groups using diverse technologies. These findings represent a paradigm shift in AF, focusing on sustaining mechanisms, as is currently done with other arrhythmias such as atrioventricular node reentrant tachycardia. Studies are currently underway to assess the optimal strategy for the application of rotor-based ablation in AF management, including clinical trials on the relative efficacy of rotor-only ablation versus PVI-only ablation, which will inform future practice guidelines.

A shift in coronary care unit patient population: Ten year experience from an urban tertiary care center.

The need for cardiovascular expertise in the treatment of advanced heart failure (AHF), malignant arrhythmias, and structural heart disease has shifted the role of the CCU to a more diverse and medically complex patient population. This study's purpose was to analyze the temporal trends in the principal diagnosis leading to admission to the CCU in a tertiary referral hospital. Over the last 15 years, the CCU has evolved from a medical unit strictly focusing on the care of patients with ACS to an advanced cardiac intensive care unit. The trends observed at our center provide further evidence that today's CCU contains a broader, more complex, critically-ill patient population.

Influenza and coronary artery disease: exploring a clinical association with myocardial infarction and analyzing the utility of vaccination in prevention of myocardial infarction.

Both coronary artery disease and influenza outbreaks contribute significantly to worldwide morbidity and mortality. An increasing number of epidemiologic studies have concluded that a temporal association exists between acute viral illnesses and myocardial infarction. Viral illnesses such as influenza can cause or exacerbate coronary atherosclerosis by activating inflammatory pathways. Data from a large case-controlled trial and two randomized controlled trials suggest that influenza vaccination in patients with coronary artery disease may lead to a decrease in incidence, morbidity, and mortality from acute myocardial infarction. A meta-analysis of the two randomized controlled trials for cardiovascular death demonstrated a pooled relative risk of 0.39 (95% confidence interval, 0.20-0.77) for patients who received the influenza vaccine compared with placebo.

Strict versus liberal target range for perioperative glucose in patients undergoing coronary artery bypass grafting: a prospective randomized controlled trial.

OBJECTIVE: The purpose of this study was to test the hypothesis that a liberal blood glucose strategy (121-180 mg/dL) is not inferior to a strict blood glucose strategy (90-120 mg/dL) for outcomes in patients after first-time isolated coronary artery bypass grafting and is superior for glucose control and target blood glucose management. METHODS: A total of 189 patients undergoing coronary artery bypass grafting were investigated in this prospective randomized study to compare 2 glucose control strategies on patient perioperative outcomes. Three methods of analyses (intention to treat, completer, and per protocol) were conducted. Observed power was robust (>80%) for significant results. RESULTS: The groups were similar on preoperative hemoglobin A(1c) and number of diabetic patients. The liberal group was found to be noninferior to the strict group for perioperative complications and superior on glucose control and target range management. The liberal group had significantly fewer patients with hypoglycemic events (<60 mg/dL; P < .001), but severe hypoglycemic events (<40 mg/dL) were rare and no group differences were found (P = .23). These results were found with all 3 methods of analysis except for blood glucose variability, maximum blood glucose, and perioperative atrial fibrillation. CONCLUSIONS: This study demonstrated that maintenance of blood glucose in a liberal range after coronary artery bypass grafting led to similar outcomes compared with a strict target range and was superior in glucose control and target range management. On the basis of the results of this study, a target blood glucose range of 121 to 180 mg/dL is recommended for patients after coronary artery bypass grafting as advocated by the Society of Thoracic Surgeons.

Performance of four risk algorithms in predicting intermediate survival in patients undergoing aortic valve replacement.

OBJECTIVE: : Several risk models exist to predict operative outcomes after cardiac surgery and are used in selecting patients for alternative procedures such as transcatheter valve implantation. We sought to evaluate the performance of the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) model in accurately identifying patients at high risk for aortic valve replacement (AVR). METHODS: : Three hundred and ninety four consecutive patients who underwent isolated AVR from January 1, 2001, to July 1, 2007, at a tertiary care center were analyzed using the STS database. Patients were stratified into tertiles according to operative surgical risk calculated by the four models [STS-PROM, European system for cardiac operative risk evaluation (EuroSCORE), Ambler, and Providence]. Vital status at 1 year was determined using the National Death Index and Social Security Death Index. RESULTS: : There were 310 low-risk patients, 56 intermediate-risk patients, and 28 high-risk patients with respect to the STS-PROM. The predicted risk of death for the low-risk, intermediate-risk, and high-risk groups were 2.4% ± 1.1%, 6.9% ± 1.4%, 15.8% ± 7.6% (P < 0.001) with respect to the STS-PROM model. Actual operative mortality for each respective group was 1.94%, 5.36%, 14.29% (P < 0.001) and 1-year mortality was 3.23%, 12.50%, 21.43% (P < 0.001), respectively. CONCLUSIONS: : High-risk patients have significantly high mortality after AVR. The STS-PROM accurately predicts operative mortality and can be used to predict 1-year survival as well. This risk model may be preferentially used instead of the EuroSCORE.