Dofetilide for the treatment of premature ventricular complexes and ventricular tachycardia in patients with structural heart disease.

BACKGROUND: Dofetilide is a class III antiarrhythmic agent approved for the treatment of atrial fibrillation and atrial flutter. Given the efficacy of other class III agents, it has been used off-label for the treatment of premature ventricular complexes (PVCs) and ventricular tachycardias (VTs). OBJECTIVE: The purpose of this study was to determine the efficacy and safety of dofetilide for ventricular arrythmias (VAs). METHODS: In this retrospective cohort study, 81 patients (59 men; age = 60 ± 14 years; LVEF = 0.34 ± 0.16) were admitted for dofetilide initiation to treat PVCs (29), VTs (42) or both (10). A ≥ 80% decrease in PVC burden was defined as a satisfactory response. An ICD was present in 72 patients (89%). Another antiarrhythmic was previously used in 50 patients (62%). Prior catheter ablation had been performed in 33 patients (41%). RESULTS: During intitiation, dofetilide was discontinued in 12 patients (15%) due to QT prolongation (8) and inefficacy to suppress VAs (4). Among the 32 patients with PVCs who successfully started dofetilide, the mean PVC burden decreased from 20 ± 10% to 8 ± 8% at a median follow-up of 2.6 months (p < .001). PVC burden was reduced by ≥80% in only 11/32 patients (34%). During 7 ± 1 years of follow-up, 41/69 patients (59%) continued to have VAs and received appropriate ICD therapies for monomorphic VTs (35) and polymorphic VT/VF (6) at a median of 8.0 (IQR 2.6-33.2) months. Dofetilide had to be discontinued in 50/69 patients (72%) due to inefficacy or intolerance. The composite outcome of VT/VF recurrence, heart transplantation, or death occurred in 6/12 patients (50%) without dofetilide and 49/69 patients (71%) with dofetilide. The event free survival was similar between patients treated with and without dofetilide (log-rank p = .55). CONCLUSIONS: Treatment with dofetilide was associated with a decrease in PVCs, however clinically significant suppression occurred in a minority of patients. Dofetilide failed to suppress the occurrence of VTs in a majority of patients.

Three-dimensional-guided and ICE-guided transseptal puncture for cardiac ablations: A propensity score match study.

INTRODUCTION: Transseptal puncture (TSP) is routinely performed for left atrial ablation procedures. The use of a three-dimensional (3D) mapping system or intracardiac echocardiography (ICE) is useful in localizing the fossa ovalis and reducing fluoroscopy use. We aimed to compare the safety and efficacy between 3D mapping system-guided TSP and ICE-guided TSP techniques. METHODS: We conducted a prospective observational study of patients undergoing TSP for left atrial catheter ablation procedures (mostly atrial fibrillation ablation). Propensity scoring was used to match patients undergoing 3D-guided TSP with patients undergoing ICE-guided TSP. Logistic regression was used to compare the clinical data, procedural data, fluoroscopy time, success rate, and complications between the groups. RESULTS: Sixty-five patients underwent 3D-guided TSP, and 151 propensity score-matched patients underwent ICE-guided TSP. The TSP success rate was 100% in both the 3D-guided and ICE-guided groups. Median needle time was 4.00 min (interquartile range [IQR]: 2.57-5.08) in patients with 3D-guided TSP compared to 4.02 min (IQR: 2.83-6.95) in those with ICE-guided TSP (p = .22). Mean fluoroscopy time was 0.2 min (IQR: 0.1-0.4) in patients with 3D-guided TSP compared to 1.2 min (IQR: 0.7-2.2) in those with ICE-guided TSP (p < .001). There were no complications related to TSP in both group. CONCLUSIONS: Three-dimensional mapping-guided TSP is as safe and effective as ICE-guided TSP without additional cost.

A comparison of clinical outcomes and cost of radiofrequency catheter ablation for atrial fibrillation with monitored anesthesia care versus general anesthesia.

INTRODUCTION: Monitored anesthesia care (MAC) or general anesthesia (GA) can be used during catheter ablation (CA) of atrial fibrillation (AF). However, each approach may have advantages and disadvantages with variability in operator preferences. The optimal approach has not been well established. The purpose of this study was to compare procedural efficacy, safety, clinical outcomes, and cost of CA for AF performed with MAC versus GA. METHODS: The study population consisted of 810 consecutive patients (mean age: 63 ± 10 years, paroxysmal AF: 48%) who underwent a first CA for AF. All patients completed a preprocedural evaluation by the anesthesiologists. Among the 810 patients, MAC was used in 534 (66%) and GA in 276 (34%). Ten patients (1.5%) had to convert to GA during the CA. RESULTS: Although the total anesthesia care was longer with GA particularly in patients with persistent AF, CA was shorter by 5 min with GA than MAC (p < 0.01). Prevalence of perioperative complications was similar between the two groups (4% vs. 4%, p = 0.89). There was no atrioesophageal fistula with either approach. GA was associated with a small, ~7% increase in total charges due to longer anesthesia care. During 43 ± 17 months of follow-up after a single ablation procedure, 271/534 patients (51%) in the MAC and 129/276 (47%) patients in the GA groups were in sinus rhythm without concomitant antiarrhythmic drug therapy (p = 0.28). CONCLUSION: With the participation of an anesthesiologist, and proper preoperative assessment, CA of AF using GA or MAC has similar efficacy and safety.

Development and validation of a risk score for predicting pericardial effusion in patients undergoing leadless pacemaker implantation: experience with the Micra transcatheter pacemaker.

AIMS: There is limited information on what clinical factors are associated with the development of pericardial effusion after leadless pacemaker implantation. We sought to determine predictors of and to develop a risk score for pericardial effusion in patients undergoing Micra leadless pacemaker implantation attempt. METHODS AND RESULTS: Patients (n = 2817) undergoing implant attempt from the Micra global trials were analysed. Characteristics were compared between patients with and without pericardial effusion (including cardiac perforation and tamponade). A risk score for pericardial effusion was developed from 18 pre-procedural clinical variables using lasso logistic regression. Internal validation and future prediction performance were estimated using bootstrap resampling. The scoring system was also externally validated using data from the Micra Acute Performance European and Middle East (MAP EMEA) registry. There were 32 patients with a pericardial effusion [1.1%, 95% confidence interval (CI): 0.8-1.6%]. Following lasso logistic regression, 11 of 18 variables remained in the model from which point values were assigned. The C-index was 0.79 (95% CI: 0.71-0.88). Patient risk score profile ranged from -4 (lowest risk) to 5 (highest risk) with 71.8% patients considered low risk (risk score ≤0), 16.6% considered medium risk (risk score = 1), and 11.7% considered high risk (risk score ≥2) for effusion. The median C-index following bootstrap validation was 0.73 (interquartile range: 0.70-0.75). The C-index based on 9 pericardial effusions from the 928 patients in the MAP EMEA registry was 0.68 (95% CI: 0.52-0.83). The pericardial effusion rate increased significantly with additional Micra deployments in medium-risk (P = 0.034) and high-risk (P < 0.001) patients. CONCLUSION: The overall rate of pericardial effusion following Micra implantation attempt is 1.1% and has decreased over time. The risk of pericardial effusion after Micra implant attempt can be predicted using pre-procedural clinical characteristics with reasonable discrimination. CLINICAL TRIAL REGISTRATION: The Micra Post-Approval Registry (ClinicalTrials.gov identifier: NCT02536118), Micra Continued Access Study (ClinicalTrials.gov identifier: NCT02488681), and Micra Transcatheter Pacing Study (ClinicalTrials.gov identifier: NCT02004873).

Lead damage after cardiac implantable device replacement procedure: Comparison between electrical plasma tool and electrocautery.

BACKGROUND: Lead damage is a complication caused by lead manipulation or heating damage from conventional electrocautery (EC) after cardiovascular implantable electronic device (CIED) replacement. Application of electrical plasma (PEAK PlasmaBlade) is a new technology that reportedly reduces this risk. OBJECTIVES: This study was designed to compare the effect of EC versus PEAK PlasmaBlade on lead parameters and complications after generator replacement procedures. METHODS: We retrospectively studied 410 consecutive patients (840 leads) who underwent CIED replacement using EC (EC group) and 410 consecutive patients (824 leads) using PEAK PlasmaBlade (PlamaBlade group). Pacing lead impedance, incidence of lead damage, and complications were compared between both groups. RESULTS: Lead impedance increased in 393 leads (46.8%) in the EC group versus 282 leads (34.2%) in the PlasmaBlade group (p < .01) with average percent changes of 6.7% and 4.0% (p < .01), respectively. Lead impedance decreased in 438 leads (52.1%) in the EC group versus 507 leads (61.5%) in the PlasmaBlade group (p < .01) with average percent changes of -5.7% and -7.1% (p < .01), respectively. Lead damage requiring lead revision occurred in five leads (0.6%) or after five procedures (1.2%) in the EC group compared to three leads (0.4%, p = .50) or after three procedures (0.7%, p = .48) in the PlasmaBlade group. There were no significant differences in the procedural-related complications between the EC group (nine patients, 2.2%) and the PlasmaBlade group (five patients, 1.2%, p = .28). CONCLUSION: Conventional electrocautery can potentially damage lead insulations. However, this study shows that when used carefully electrocautery is as safe as the PEAK PlasmaBlade™.

Efficacy and tolerability of quinidine as salvage therapy for monomorphic ventricular tachycardia in patients with structural heart disease.

INTRODUCTION: Quinidine is an effective therapy for a subset of polymorphic ventricular tachycardia and ventricular fibrillation (VF) syndromes; however, the efficacy of quinidine in scar-related monomorphic ventricular tachycardia (MMVT) is unclear. METHODS AND RESULTS: Between 2009 and 2020 a single VT referral center, a total of 23 patients with MMVT and structural heart disease (age 66.7 ± 10.9, 20 males, 15 with ischemic cardiomyopathy, mean LVEF 22.2 ± 12.3%, 9 with left ventricular assist device [LVAD]) were treated with quinidine (14 quinidine gluconate; 996 ± 321 mg, 8 quinidine sulfate; 1062 ± 588 mg). Quinidine was used in combination with other antiarrhythmics (AAD) in 19 (13 also on amiodarone). All patients previously failed >1 AAD (amiodarone 100%, mexiletine 73%, sotalol 32%, other 32%) and eight had prior ablations (median of 1.5). Quinidine was initiated in the setting of VT storm despite AADs (6), inability to tolerate other AADs (4), or recurrent VT(12). Ventricular arrhythmias recurred despite quinidine in 13 (59%) patients at a median of 26 (4-240) days after quinidine initiation. In patients with recurrent MMVT, VT cycle length increased from 359 to 434 ms (p = .02). Six (27.3%) patients remained on quinidine at 1 year with recurrence of ventricular arrhythmias in all. The following adverse effects were seen: gastrointestinal side effects (6), QT prolongation (2), rash (1), thrombocytopenia (1), neurologic side effects (1). One patient discontinued due to cost. CONCLUSION: Quinidine therapy has limited tolerability and long-term efficacy when used in the management of amiodarone-refractory scar-related MMVT.

Effect of metformin on outcomes of catheter ablation for atrial fibrillation.

BACKGROUND: Diabetes mellitus (DM) is a risk factor for atrial fibrillation (AF). The effect of antidiabetic medications on AF or the outcomes of catheter ablation (CA) has not been well described. We sought to determine whether metformin treatment is associated with a lower risk of atrial arrhythmias after CA in patients with DM and AF. METHODS AND RESULTS: A first CA was performed in 271 consecutive patients with DM and AF (age: 65 ± 9 years, women: 34%; and paroxysmal AF: 51%). At a median of 13 months after CA (interquartile range: 6-30), 100/182 patients (55%) treated with metformin remained in sinus rhythm without antiarrhythmic drug therapy, compared with 36/89 patients (40%) not receiving metformin (p = .03). There was a significant association between metformin therapy and freedom from recurrent atrial arrhythmias after CA in multivariable Cox hazards models (hazard ratio [HR]: 0.66; ±95% confidence interval [CI]: 0.44-0.98; p = .04) that adjusted for age, sex, body mass index, AF type (paroxysmal vs. nonparoxysmal), antiarrhythmic medication, obstructive sleep apnea, chronic kidney disease, coronary artery disease, left ventricular ejection fraction, and left atrial diameter. A Cox model that also incorporated other antidiabetic agents and fasting blood glucose demonstrated a similar reduction in the risk of recurrent atrial arrhythmias with metformin treatment (HR: 0.63; ±95% CI: 0.42-0.96; p = .03). CONCLUSIONS: In patients with DM, treatment with metformin appears to be independently associated with a significant reduction in the risk of recurrent atrial arrhythmias after CA for AF. Whether this effect is due to glycemic control or pleiotropic effects on electroanatomical mechanisms of AF remains to be determined.

Baseline and decline in device-derived activity level predict risk of death and heart failure in patients with an ICD for primary prevention.

BACKGROUND: Implanted defibrillators are capable of recording activity data based on company-specific proprietary algorithms. This study aimed to determine the prognostic significance of baseline and decline in device-derived activity level across different device companies in the real world. METHODS: We performed a retrospective cohort study of patients (n = 280) who underwent a defibrillator implantation (Boston, Medtronic, St. Jude, and Biotronik) for primary prevention at the University of Michigan from 2014 to 2016. Graphical data obtained from device interrogations were retrospectively converted to numerical data. The activity level averaged over a month from a week postimplantation was used as baseline. Subsequent weekly average activity levels (SALs) were standardized to this baseline. SAL below 59.4% was used as a threshold to group patients. All-cause mortality and death/heart failure were the primary end-points of this study. RESULTS: Fifty-six patients died in this study. On average, they experienced a 50% decline in SAL prior to death. Patients (n = 129) who dropped their SAL below threshold were more likely to be older, male, diabetic, and have more symptomatic heart failure. They also had a significantly increased risk of heart failure/death (hazard ratio [HR] 3.6, 95% confidence interval [95% CI] 2.3-5.8, P < .0001) or death (HR 4.2, 95% CI 2.2-7.7, P < .0001) compared to those who had sustained activity levels. Lower baseline activity level was also associated with significantly increased risk of heart failure/death and death. CONCLUSION: Significant decline in device-derived activity level and low baseline activity level are associated with increased mortality and heart failure in patients with an ICD for primary prevention.

Relationship of non-invasive quantification of myocardial blood flow to arrhythmic events in patients with implantable cardiac defibrillators.

BACKGROUND: Ischemia contributes to arrhythmogenesis though its role is incompletely understood. Abnormal myocardial perfusion measured by PET imaging may predict ventricular arrhythmias (VAs) in a high-risk population. METHODS: Patients with implantable cardiac defibrillators who had undergone rubidium-82 cardiac PET imaging were identified. Patients were stratified by median MBF and MFR values for analysis. The Cox proportional hazards model was used to assess the impact of myocardial perfusion on survival free of VT independent of critical covariates. RESULTS: A total of 159 patients (124 (78%) males, median age 65.9 years, IQR [56.76-72.63]) were followed for 1.43 years IQR [0.83-2.21]. VA occurred in 29 patients (23.7%). After adjustment for ejection fraction, age, and sex, impaired stress MBF was associated with an increased risk of VA (adjusted HR per ml/min/g 1.52, 95% CI (1.01-2.31), P = 0.04). Summed rest and stress scores were not predictive of VA. Among patients with severe LV dysfunction, stress MBF remained an independent predictor of VA (adjusted HR per 1 ml/min/g HR 1.69, 95% CI (1.03-11.36), P = 0.03), while residual EF, summed rest, and summed stress scores were not (P > 0.05). CONCLUSIONS: Impaired stress myocardial blood flow was associated with less survival free of ventricular arrhythmias.

Atrioventricular conduction in patients undergoing pacemaker implant following self-expandable transcatheter aortic valve replacement.

BACKGROUND: Heart block requiring a pacemaker is common after self-expandable transcatheter aortic valve replacement (SE-TAVR); however, conduction abnormalities may improve over time. Optimal device management in these patients is unknown. OBJECTIVE: To evaluate the long-term, natural history of conduction disturbances in patients undergoing pacemaker implantation following SE-TAVR. METHODS: All patients who underwent new cardiac implantable electronic device (CIED) implantation at Michigan Medicine following SE-TAVR placement between January 1, 2012 and September 25, 2017 were identified. Electrocardiogram and device interrogation data were examined during follow-up to identify patients with recovery of conduction. Logistic regression analysis was used to compare clinical and procedural variables to predict conduction recovery. RESULTS: Following SE-TAVR, 17.5% of patients underwent device placement for new atrioventricular (AV) block. Among 40 patients with an average follow-up time of 17.1 ± 8.1 months, 20 (50%) patients had durable recovery of AV conduction. Among 20 patients without long-term recovery, four (20%) had transient recovery. The time to transient conduction recovery was 2.2 ± 0.2 months with repeat loss of conduction at 8.2 ± 0.9 months. On multivariate analysis, larger aortic annular size (odds ratio: 0.53 [0.28-0.86]/mm, P = 0.02) predicted lack of conduction recovery. CONCLUSIONS: Half of the patients undergoing CIED placement for heart block following SE-TAVR recovered AV conduction within several months and maintained this over an extended follow-up period. Some patients demonstrated transient recovery of conduction before recurrence of conduction loss. Larger aortic annulus diameter was negatively associated with conduction recovery.

Ablation of paroxysmal atrial fibrillation using a second-generation cryoballoon catheter or contact-force sensing radiofrequency ablation catheter: A comparison of costs and long-term clinical outcomes.

INTRODUCTION: Although noninferiority of cryoballoon ablation (CBA) and radiofrequency catheter ablation for antral pulmonary vein isolation (APVI) has been reported in patients with paroxysmal atrial fibrillation (PAF), it is not clear whether contact force sensing (CF-RFA) and CBA with the second-generation catheter have similar procedural costs and long-term outcomes. The objective of this study is to compare the long-term efficacy and cost implications of CBA and CF-RFA in patients with PAF. METHODS AND RESULTS: A first APVI was performed in 146 consecutive patients (age: 63 ± 10 years, men: 95 [65%], left atrial diameter: 42 ± 6 mm) with PAF using CBA (71) or CF-RFA (75). Clinical outcomes and procedural costs were compared. The mean procedure time was significantly shorter with CBA than with CF-RFA (98 ± 39 vs. 158 ± 47 minutes, P < 0.0001). Despite a higher equipment cost in the CBA than the CF-RFA group, the total procedure cost was similar between the two groups (P = 0.26), primarily driven by a shorter procedure duration that resulted in a lower anesthesia cost. At 25 ± 5 months after a single ablation procedure, 51 patients (72%) in the CBA, and 55 patients (73%) in the CF-RFA groups remained free from atrial arrhythmias without antiarrhythmic drug therapy (P = 0.84). CONCLUSIONS: The procedure duration was approximately 60 minutes shorter with CBA than CF-RFA. The procedural costs were similar with both approaches. At 2 years after a single procedure, CBA and CF-RFA have similar single-procedure efficacies of 72-73%.

Perioperative hematoma with subcutaneous ICD implantation: Impact of anticoagulation and antiplatelet therapies.

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 < 0.0001) in combination with aspirin in 12/14 patients. Any bridging AC (odds ratio [OR] 10.3, 1.8-60.8, P = 0.01), clopidogrel (OR 10.0, 1.7-57.7, P = 0.01), and uninterrupted warfarin without bridging (OR 11.1, 1.7-74.3, P = 0.013) were independently associated with hematoma formation. CONCLUSION: AC and/or AP therapy with clopidogrel appears to increase the risk for hematoma following S-ICD implantation. Interruption of AC without bridging should be considered when it is an acceptable risk to hold AC.

Leadless Ultrasound-Based Cardiac Resynchronization System in Heart Failure.

Importance: Approximately 40% of patients with heart failure (HF) who are eligible for cardiac resynchronization therapy (CRT) either fail to respond or are untreatable due to anatomical constraints. Objective: To assess the safety and efficacy of a novel, leadless, left ventricular (LV) endocardial pacing system for patients at high risk for a CRT upgrade or whose coronary sinus (CS) lead placement/pacing with a conventional CRT system failed. Design, Setting, and Participants: The SOLVE-CRT study was a prospective multicenter trial enrolling January 2018 through July 2022, with follow-up at 6 months. Data were analyzed from January 17, 2018, through February 15, 2023. The trial combined data from an initial randomized, double-blind study (n = 108) and a subsequent single-arm part (n = 75). It took place at 36 centers across Australia, Europe, and the US. Participants were nonresponders, previously untreatable (PU), or high-risk upgrades (HRU). All participants contributed to the safety analysis. The primary efficacy analysis (n = 100) included 75 PU-HRU patients from the single-arm part and 25 PU-HRU patients from the randomized treatment arm. Interventions: Patients were implanted with the WiSE CRT System (EBR Systems) consisting of a leadless LV endocardial pacing electrode stimulated with ultrasound energy delivered by a subcutaneously implanted transmitter and battery. Main Outcomes and Measures: The primary safety end point was freedom from type I complications. The primary efficacy end point was a reduction in mean LV end systolic volume (LVESV). Results: The study included 183 participants; mean age was 68.1 (SD, 10.3) years and 141 were male (77%). The trial was terminated at an interim analysis for meeting prespecified stopping criteria. In the safety population, patients were either New York Heart Association Class II (34.6%) or III (65.4%). The primary efficacy end point was met with a 16.4% (95% CI, -21.0% to -11.7%) reduction in mean LVESV (P = .003). The primary safety end point was met with an 80.9% rate of freedom from type I complications (P < .001), which included 12 study device system events (6.6%), 5 vascular events (2.7%), 3 strokes (1.6%), and 7 cardiac perforations which mostly occurred early in the study (3.8%). Conclusions and Relevance: The SOLVE-CRT study has demonstrated that leadless LV endocardial pacing with the WiSE CRT system is associated with a reduction in LVESV in patients with HF. This novel system may represent an alternative to conventional CRT implants in some HF patient populations. Trial Registration: ClinicalTrials.gov Identifier: NCT0292203.

Hypertensive goals in patients with coronary artery disease.

There are many prospective clinical trials that have examined cardiovascular outcomes over the past 2 decades. Trials completed within the last 5 years clearly indicate that overall cardiovascular risk is reduced by blood pressure lowering to levels below 140/90 mm Hg. Greater cardiovascular risk reduction is not seen, however, by driving blood pressure to levels well below 130/80 mm Hg. This is true across the spectrum of cardio-renal risk with few exceptions, stroke prevention possibly being one. Further there should be an awareness that outcome studies performed within the last decade will not have the same risk reduction of a given class of antihypertensive drug previously tested. This is primarily due to an improved standard of care that was not present in trials of a decade ago and thus, more recent trials have lower cardiovascular risk at baseline. Lastly, new guidelines will most likely change the goal blood pressure to <140/90 mm Hg as all data support this level. Lastly, the caution of lowering diastolic blood pressure below 60 mm Hg especially in the elderly must be avoided to minimize reductions in coronary perfusion.

Double ProGlide preclose technique for vascular access closure after leadless pacemaker implantation.

PURPOSE: The use of vascular closure devices in patients receiving the Micra leadless pacemaker may shorten time to ambulation, facilitate same-day discharge, and reduce risk of venous thrombosis associated with manual hemostasis. We sought evaluate the feasibility of double Perclose ProGlide (Abbott, CA) preclosure for access site hemostasis after leadless pacemaker implant. METHODS: Patients with leadless pacemaker implant and double preclosure for access hemostasis from 2020 to 2021 were reviewed for complications requiring increase of flat time or transfusion, incidence of venous thromboembolism, and hemoglobin decrement. Two ProGlide devices were deployed with a double preclose technique after ultrasound guided wire access. Patients were instructed to lay flat for 2-4 h and were allowed to ambulate after. RESULTS: A total of 36 patients (age 74.5 ± 15.1 years, BMI 27.9 ± 9.0 kg/m2, 30% female gender) were included with 6 having prior venous thromboembolism, 21 with AF, and 15 with chronic kidney disease. Anticoagulation was continued in 14 (8 direct oral anticoagulants, 2 warfarin, 4 intravenous heparin) and interrupted in 5. In one patient, minor rebleeding prompted 10 min of manual pressure and extension of flat time by 2 h. No patients had other complications, prolongation of flat time, transfusion, delayed re-initiation of anticoagulation, or venous thromboembolism within 30 days. CONCLUSIONS: The double preclose technique is a safe and feasible method of achieving access site hemostasis and facilitates early ambulation after leadless pacemaker implantation.

Clinical characteristics and long-term outcomes of catheter ablation in young adults with atrial fibrillation.

PURPOSE: We aim to describe the long-term safety and efficacy of catheter ablation (CA) in young patients (<30 years) with atrial fibrillation (AF). METHODS: This was a retrospective study of patients aged 18-30 who underwent CA for AF, and clinical characteristics and long-term outcomes are reported. Survival analyses were performed between the study group and a propensity-matched older cohort (>30 years, mean age: 58±10 years). RESULTS: From January 2000 to January 2019, a 1st CA (radiofrequency energy n=72, cryoballoon n=10), was performed in 82 patients (mean age 26±4 years, paroxysmal n=61, persistent n=14, longstanding persistent n=7), among 6336 consecutive patients with AF. During a follow-up of 5±5 years, 56% and 30% of the patients with paroxysmal and non-paroxysmal AF were arrhythmia free without antiarrhythmic drug (AAD) therapy after a single CA (P=0.02). After 1.5±0.8 CA procedures, 76% and 75% of the patients with paroxysmal AF and non-paroxysmal AF were arrhythmia free without AADs (P=0.54). Compared to a propensity-matched group of older patients, young patients were as likely to remain in sinus rhythm after CA (P=0.47), however after fewer repeat CAs (1.5±0.8 vs 1.9±0.9, P<0.009). There were no long-term adverse outcomes associated with CA. CONCLUSIONS: CA is a safe and effective treatment of AF in young patients with comparable outcomes to the older patients, however after fewer procedures.

Comparative Efficacy of Dofetilide Versus Amiodarone in Patients With Atrial Fibrillation.

OBJECTIVES: The study's goal was to compare the efficacy and safety of dofetilide (DOF) versus amiodarone (AMIO) in patients with atrial fibrillation (AF). BACKGROUND: Comparative efficacy of DOF versus AMIO in patients with AF has not been well established. In addition, proarrhythmia has been a concern with DOF therapy. METHODS: Rhythm control was attempted by using DOF in 657 consecutive patients (mean age 72 ± 9 years; 35% women) with AF (n = 528) or atrial flutter and AF (n = 129) between January 2014 and December 2018. RESULTS: DOF was successfully initiated in 573 (87%) of 657 patients, including 510 (89%) with persistent AF and 63 (11%) with paroxysmal AF. During a mean follow-up of 19 ± 7 months, sinus rhythm was maintained in 361 (63%) of the 573 DOF-treated patients. At 12 months, patients on DOF had a similar likelihood of experiencing recurrent atrial arrhythmias compared with the 2,476 consecutive patients treated with AMIO for rhythm control during the study period (37% vs. 39%; p = 0.56). The efficacy of DOF and AMIO was also similar in specific subgroups of patients, including patients >75 years of age, with a low left ventricular ejection fraction, obesity, renal insufficiency, and prior catheter ablation for AF. Among patients with atypical atrial flutter, likelihood of recurrent atrial flutter was similar between the DOF (43 of 108 [40%]) and AMIO (211 of 555 [38%]; p = 0.69) groups. CONCLUSIONS: When properly initiated and monitored, DOF has efficacy comparable to that of amiodarone for rhythm control in patients with AF.

Hybrid venous recanalization and cardiac implantable electronic device lead revision procedures: A single-center retrospective analysis of 38 patients.

PURPOSE: The purpose of this study was to describe the safety and efficacy of hybrid recanalization procedures in a series of patients with obstructed central veins requiring cardiac implantable electronic device (CIED) revision. METHODS: Between 2008 and 2016, 38 consecutive patients (24 M; age 60.5 ±â€¯16.2 years; range 25-87 years) with central venous obstruction underwent 42 recanalization interventions performed in conjunction with CIED revision or extraction. Fifty percent of patients (19/38) presented with veno-occlusive symptoms, and 13% (5/38) of patients had CIED leads with an ipsilateral upper extremity dialysis conduit. RESULTS: Ninety-one percent (38/42) of all procedures resulted in successful recanalization and CIED revision. Twenty-four percent (9/38) of all patients required secondary procedures due to recurrent stenosis, and 78% (7/9) of those requiring secondary procedures had indwelling dialysis conduits and/or clinical symptoms related to venous occlusion before the initial procedure. There were complications in 2 patients related to recanalization, and in 3 related to CIED revision. CONCLUSIONS: Recanalization of central venous stenosis/occlusion in patients with CIED can be technically challenging but is successful in most patients. Symptomatic patients and those with dialysis conduits often require more aggressive revascularization interventions and may be at increased risk of complication or need for secondary interventions.

Antiarrhythmic drug therapy and all-cause mortality after catheter ablation of atrial fibrillation: A propensity-matched analysis.

BACKGROUND: It is not clear if antiarrhythmic drug therapy (AAD) after catheter ablation (CA) of atrial fibrillation (AF) increases mortality. OBJECTIVE: To determine whether there is an association between AAD therapy and mortality after CA of AF. METHODS: There were 3624 consecutive patients with AF (mean age: 59 ± 11 years, women: 27%, paroxysmal AF: 58%). An AAD was used in 2253 patients (62%, AAD group) for a mean duration of 1.3 ± 0.8 years, during a mean follow-up of 6.7 ± 2.2 years after CA of AF. Using propensity score matching, with every 2 patients using an AAD matched to 1 patient who did not use AAD (NO-AAD group), Cox regression models were utilized to assess the association between AAD use (as a time-variable covariate) and all-cause mortality. RESULTS: There were a total of 50 deaths (2.2%) in the AAD and 62 deaths (4.5%) in the NO-AAD groups, respectively (P = .02). At the time of death, 46 of 50 patients (92%) who died in the AAD cohort were still using an AAD (P = .21, compared to baseline use). On multivariate analysis, although the risk of death was not statistically significant between the AAD and NO-AAD cohorts, there was a trend towards mortality benefit with AAD therapy (hazard ratio [HR]: 0.66, 95% confidence interval [CI]: 0.43-1.00, P = .05), regardless of the rhythm or anticoagulation status. CONCLUSION: AAD use after CA of AF is not associated with an increased risk of mortality, suggesting that when carefully chosen and monitored, AADs appear to be safe after CA of AF.