Same-day discharge following catheter ablation and venous closure with VASCADE MVP: A postmarket registry.

INTRODUCTION: Early and safe ambulation can facilitate same-day discharge (SDD) following catheter ablation, which can reduce resource utilization and healthcare costs and improve patient satisfaction. This study evaluated procedure success and safety of the VASCADE MVP venous vascular closure system in patients with atrial fibrillation (AF). METHODS: The AMBULATE SDD Registry is a two-stage series of postmarket studies in patients with paroxysmal or persistent AF undergoing catheter ablation followed by femoral venous access-site closure with VASCADE MVP. Efficacy endpoints included SDD success, defined as the proportion of patients discharged the same day who did not require next-day hospital intervention for procedure/access site-related complications, and access site sustained success within 15 days of the procedure. RESULTS: Overall, 354 patients were included in the pooled study population, 151 (42.7%) treated for paroxysmal AF and 203 (57.3%) for persistent AF. SDD was achieved in 323 patients (91.2%) and, of these, 320 (99.1%) did not require subsequent hospital intervention based on all study performance outcomes. Nearly all patients (350 of 354; 98.9%) achieved total study success, with no subsequent hospital intervention required. No major access-site complications were recorded. Patients who had SDD were more likely to report procedure satisfaction than patients who stayed overnight. CONCLUSION: In this study, 99.7% of patients achieving SDD required no additional hospital intervention for access site-related complications during follow-up. SDD appears feasible and safe for eligible patients after catheter ablation for paroxysmal or persistent AF in which the VASCADE MVP is used for venous access-site closure.

A wearable cardioverter defibrillator with a low false alarm rate.

INTRODUCTION: A wearable cardioverter defibrillator (WCD) is indicated in appropriate patients to reduce the risk for sudden cardiac death. Challenges for patients wearing a WCD have been frequent false shock alarms primarily due to electrocardiogram noise and wear discomfort. The objective of this study was to test a contemporary WCD designed for reduced false shock alarms and improved comfort. METHODS: One hundred and thirty patients with left ventricular ejection fraction ≤40% and an active implantable cardioverter defibrillator (ICD) were fitted with the ASSURE WCD (Kestra Medical Technologies) and followed for 30 days. WCD detection was enabled and shock alarm markers recorded, but shocks and shock alarms were disabled. All WCD episodes and ICD ventricular tachycardia/ventricular fibrillation (VT/VF) episodes were adjudicated. The primary endpoint was the false-positive shock alarm rate with a performance goal of 1 every 3.4 days (0.29 per patient-day). RESULTS: Of 163 WCD episodes, 4 were VT/VF and 159 non-VT/VF (121 rhythms with noise, 32 uncertain with noise, 6 atrial flutter without noise). Only three false-positive shock alarm markers were recorded; one false-positive shock alarm every 1333 patient-days (0.00075 per patient-day, 95% confidence interval: 0.00015-0.00361; p < .001). No ICD recorded VT/VF episodes meeting WCD detection criteria (≥170 bpm for ≥20 s) were missed by the WCD during 3501 patient-days of use. Median wear was 31.0 days (interquartile range [IQR] 2.0) and median daily use 23.0 h (IQR 1.7). Adverse events were mostly mild: skin irritation (19.4%) and musculoskeletal discomfort (8.5%). CONCLUSION: The ASSURE WCD demonstrated a low false-positive shock alarm rate, low patient-reported discomfort, and no serious adverse events.

Effect of Catheter Ablation With Vein of Marshall Ethanol Infusion vs Catheter Ablation Alone on Persistent Atrial Fibrillation: The VENUS Randomized Clinical Trial.

Importance: Catheter ablation of persistent atrial fibrillation (AF) has limited success. Procedural strategies beyond pulmonary vein isolation have failed to consistently improve results. The vein of Marshall contains innervation and AF triggers that can be ablated by retrograde ethanol infusion. Objective: To determine whether vein of Marshall ethanol infusion could improve ablation results in persistent AF when added to catheter ablation. Design, Setting, and Participants: The Vein of Marshall Ethanol for Untreated Persistent AF (VENUS) trial was an investigator-initiated, National Institutes of Health-funded, randomized, single-blinded trial conducted in 12 centers in the United States. Patients (N = 350) with persistent AF referred for first ablation were enrolled from October 2013 through June 2018. Follow-up concluded in June 2019. Interventions: Patients were randomly assigned to catheter ablation alone (n = 158) or catheter ablation combined with vein of Marshall ethanol infusion (n = 185) in a 1:1.15 ratio to accommodate for 15% technical vein of Marshall ethanol infusion failures. Main Outcomes and Measures: The primary outcome was freedom from AF or atrial tachycardia for longer than 30 seconds after a single procedure, without antiarrhythmic drugs, at both 6 and 12 months. Outcome assessment was blinded to randomization treatment. There were 12 secondary outcomes, including AF burden, freedom from AF after multiple procedures, perimitral block, and others. Results: Of the 343 randomized patients (mean [SD] age, 66.5 [9.7] years; 261 men), 316 (92.1%) completed the trial. Vein of Marshall ethanol was successfully delivered in 155 of 185 patients. At 6 and 12 months, the proportion of patients with freedom from AF/atrial tachycardia after a single procedure was 49.2% (91/185) in the catheter ablation combined with vein of Marshall ethanol infusion group compared with 38% (60/158) in the catheter ablation alone group (difference, 11.2% [95% CI, 0.8%-21.7%]; P = .04). Of the 12 secondary outcomes, 9 were not significantly different, but AF burden (zero burden in 78.3% vs 67.9%; difference, 10.4% [95% CI, 2.9%-17.9%]; P = .01), freedom from AF after multiple procedures (65.2% vs 53.8%; difference, 11.4% [95% CI, 0.6%-22.2%]; P = .04), and success achieving perimitral block (80.6% vs 51.3%; difference, 29.3% [95% CI, 19.3%-39.3%]; P < .001) were significantly improved in vein of Marshall-treated patients. Adverse events were similar between groups. Conclusions and Relevance: Among patients with persistent AF, addition of vein of Marshall ethanol infusion to catheter ablation, compared with catheter ablation alone, increased the likelihood of remaining free of AF or atrial tachycardia at 6 and 12 months. Further research is needed to assess longer-term efficacy. Trial Registration: ClinicalTrials.gov Identifier: NCT01898221.

Wireless Smartphone ECG Enables Large-Scale Screening in Diverse Populations.

BACKGROUND: The ubiquitous presence of internet-connected phones and tablets presents a new opportunity for cost-effective and efficient electrocardiogram (ECG) screening and on-demand diagnosis. Wireless, single-lead real-time ECG monitoring supported by iOS and android devices can be obtained quickly and on-demand. ECGs can be immediately downloaded and reviewed using any internet browser. OBJECTIVE: We compared the standard 12-lead ECG to the smartphone ECG in healthy young adults, elite athletes, and cardiology clinic patients. Accuracy for determining baseline ECG intervals and rate and rhythm was assessed. METHODS: In 381 participants, 30-second lead I ECG waveforms were obtained using an iPhone case or iPad. Standard 12-lead ECGs were acquired immediately after the smartphone tracing was obtained. De-identified ECGs were interpreted by automated algorithms and adjudicated by two board-certified electrophysiologists. RESULTS: Both smartphone and standard ECGs detected atrial rate and rhythm, AV block, and QRS delay with equal accuracy. Sensitivities ranged from 72% (QRS delay) to 94% (atrial fibrillation). Specificities were all above 94% for both modalities. CONCLUSION: Smartphone ECG accurately detects baseline intervals, atrial rate, and rhythm and enables screening in diverse populations. Efficient ECG analysis using automated discrimination and an enhanced smartphone application with notification capabilities are features that can be easily incorporated into the acquisition process.

Defibrillation effectiveness and safety of the shock waveform used in a contemporary wearable cardioverter defibrillator: Results from animal and human studies.

INTRODUCTION: The wearable cardioverter defibrillator (WCD) is used to protect patients at risk for sudden cardiac arrest. We examined defibrillation efficacy and safety of a biphasic truncated exponential waveform designed for use in a contemporary WCD in three animal studies and a human study. METHODS: Animal (swine) studies: #1: Efficacy comparison of a 170J BTE waveform (SHOCK A) to a 150J BTE waveform (SHOCK B) that approximates another commercially available waveform. Primary endpoint first shock success rate. #2: Efficacy comparison of the two waveforms at attenuated charge voltages in swine at three prespecified impedances. Primary endpoint first shock success rate. #3: Safety comparison of SHOCK A and SHOCK B in swine. Primary endpoint cardiac biomarker level changes baseline to 6 and 24 hours post-shock. Human Study: Efficacy comparison of SHOCK A to prespecified goal and safety evaluation. Primary endpoint cumulative first and second shock success rate. Safety endpoint adverse events. RESULTS: Animal Studies #1: 120 VF episodes in six swine. First shock success rates for SHOCK A and SHOCK B were 100%; SHOCK A non-inferior to SHOCK B (entire 95% CI of rate difference above -10% margin, p < .001). #2: 2,160 VF episodes in thirty-six swine. Attenuated SHOCK A was non-inferior to attenuated SHOCK B at each impedance (entire 95% CI of rate difference above -10% margin, p < .001). #3: Ten swine, five shocked five times each with SHOCK A, five shocked five times each with SHOCK B. No significant difference in troponin I (p = 0.658) or creatine phosphokinase (p = 0.855) changes from baseline between SHOCK A and SHOCK B. Human Study: Thirteen patients, 100% VF conversion rate. Mild skin irritation from adhesive defibrillation pads in three patients. CONCLUSIONS: The BTE waveform effectively and safely terminated induced VF in swine and a small sample in humans. TRIAL REGISTRATION: Human study clinical trial registration: URL: https://clinicaltrials.gov; Unique identifier: NCT04132466.

Dual-chamber leadless pacing: Atrioventricular synchrony in preclinical models of normal or blocked atrioventricular conduction.

BACKGROUND: Dual-chamber leadless pacemakers (LPs) require robust communication between distinct right atrial (RA) and right ventricular (RV) LPs to achieve atrioventricular (AV) synchrony. OBJECTIVE: The purpose of this preclinical study was to evaluate a novel, continuous implant-to-implant (i2i™) communication methodology for maintaining AV-synchronous, dual-chamber DDD(R) pacing by the 2 LPs. METHODS: RA and RV LPs were implanted and paired in 7 ovine subjects (4 with induced complete heart block). AV synchrony (% AV intervals <300 ms) and i2i communication success (% successful i2i transmissions between LPs) were evaluated acutely and chronically. During acute testing, 12-lead electrocardiographic and LP diagnostic data were collected from 5-minute recordings, in 4 postures and 2 rhythms (AP-VP and AS-VP, or AP-VS and AS-VS) per subject. Chronic i2i performance was evaluated through 23 weeks postimplant (final i2i evaluation period: week 16-23). RESULTS: Acute AV synchrony and i2i communication success across multiple postures and rhythms were median [interquartile range] 100.0% [100.0%-100.0%] and 99.9% [99.9%-99.9%], respectively. AV synchrony and i2i success rates did not differ across postures (P = .59, P = .11) or rhythms (P = 1, P = .82). During the final i2i evaluation period, the overall i2i success was 98.9% [98.1%-99.0%]. CONCLUSION: Successful AV-synchronous, dual-chamber DDD(R) leadless pacing using a novel, continuous, wireless communication modality was demonstrated across variations in posture and rhythm in a preclinical model.

Retrieval of Chronically Implanted Dual-chamber Leadless Pacemakers in an Ovine Model.

BACKGROUND: The clinical utilization of leadless pacemakers (LPs) as an alternative to traditional transvenous pacemakers is likely to increase with the advent of dual-chamber LP systems. Since device retrieval to allow LP upgrade or replacement will become an important capability, the first such dual-chamber, helix-fixation LP system (Aveir DR; Abbott, Abbott Park, IL) was specifically designed to allow catheter-based retrieval. In this study, the preclinical performance and safety of retrieving chronically implanted dual-chamber LPs was evaluated. METHODS: Atrial and ventricular LPs were implanted in the right atrial appendage and right ventricular apex of 9 healthy ovine subjects. After ≈2 years, the LPs were retrieved using a dedicated transvenous retrieval catheter (Aveir Retrieval Catheter; Abbott) by snaring, docking, and unscrewing from the myocardium. Comprehensive necropsy/histopathology studies were conducted to evaluate device- and procedure-related outcomes. RESULTS: At a median of 1.9 years postimplant (range, 1.8-2.6), all 18 of 18 (100%) LPs were retrieved from 9 ovine subjects without complications. The median retrieval procedure duration for both LPs, from first-catheter-in to last-catheter-out, was 13.3 minutes (range, 2.5-36.4). Postretrieval, all right atrial, and right ventricular implant sites demonstrated minimal tissue disruption, with intact fibrous tissue limited to the distal device body. No significant device-related trauma, perforation, pericardial effusion, right heart or tricuspid valve injury, or chronic pulmonary thromboembolism were observed at necropsy. CONCLUSIONS: This preclinical study demonstrated the safe and effective retrieval of chronically implanted, helix-fixation, dual-chamber LP systems, paving the way for clinical studies of LP retrieval.

Worldwide experience with the robotic navigation system in catheter ablation of atrial fibrillation: methodology, efficacy and safety.

INTRODUCTION: The Hansen Robotic system has been utilized in ablation procedures for atrial fibrillation (AF). However, because of the lack of tactile feedback and the rigidity of the robotic sheath, this approach could result in higher risk of complications. This worldwide survey reports a multicenter experience on the methodology, efficacy, and safety of the Hansen system in AF ablations. METHODS AND RESULTS: A questionnaire addressing questions on patient's demographics, procedural parameters, ablation success rate and safety information was sent to all centers where more than 50 robotic AF ablation cases have been performed. From June 2007 to December 2009, 1,728 procedures were performed at 12 centers utilizing the Hansen robotic navigation technology. The overall complication rate was 4.7% and the success rate was 67.1% after 18 ± 4 months of follow-up. In 5 low volume centers there appeared to be a learning curve of about 50 cases (complication rate 11.2% for the first 50 cases vs 3.7% for the 51-100 cases; P = 0.044) and a trend showing a decrease of complication rate with increasing case volume. However, in the remaining 7 centers no learning curve was present and the complication rate was stable over time (3.7% for the first 50 cases vs 3.6% for the 51st case thereafter; P = 0.942). CONCLUSION: The Hansen robotic system can be used for AF ablation safely. In low volume centers, there appeared to be a learning curve of the first 50 cases after which the complication rate decreased. With a higher case volume, the success rate increased.

Determinants of outcome impact of vein of Marshall ethanol infusion when added to catheter ablation of persistent atrial fibrillation: A secondary analysis of the VENUS randomized clinical trial.

BACKGROUND: The Vein of Marshall Ethanol for Untreated Persistent AF (VENUS) trial demonstrated that adding vein of Marshall (VOM) ethanol infusion to catheter ablation (CA) improves ablation outcomes in persistent atrial fibrillation (AF). There was significant heterogeneity in the impact of VOM ethanol infusion on rhythm control. OBJECTIVE: The purpose of this study was to assess the association between outcomes and (1) achievement of bidirectional perimitral conduction block and (2) procedural volume. METHODS: The VENUS trial randomized patients with persistent AF (N = 343) to CA combined with VOM ethanol or CA alone. The primary outcome (freedom from AF or atrial tachycardia [AT] lasting longer than 30 seconds after a single procedure) was analyzed by 2 categories: (1) successful vs no perimitral block and (2) high- (>20 patients enrolled) vs low-volume centers. RESULTS: In patients with perimitral block, the primary outcome was reached 54.3% after VOM-CA and 37% after CA alone (P = .01). Among patients without perimitral block, freedom from AF/AT was 34.0% after VOM-CA and 37.0% after CA (P = .583). In high-volume centers, the primary outcome was reached in 56.4% after VOM-CA and 40.2% after CA (P = .01). In low-volume centers, freedom from AF/AT was 30.77% after VOM-CA and 32.61% after CA (P = .84). In patients with successful perimitral block from high-volume centers, the primary outcome was reached in 59% after VOM-CA and 39.1% after CA (P = .01). Tests for interaction were significant (P = .002 for perimitral block and P = .04 for center volume). CONCLUSION: Adding VOM ethanol infusion to CA has a greater impact on outcomes when associated with perimitral block and performed in high-volume centers. Perimitral block should be part of the VOM procedure.

Safety and feasibility of combined atrial fibrillation ablation and left atrial appendage occlusion after left atrial appendage electrical isolation.

OBJECTIVE: To demonstrate the feasibility of combining left atrial appendage electrical isolation (LAAEI) with left atrial appendage occlusion (LAAO) to increase efficacy of persistent/longstanding atrial fibrillation (PLAF) catheter ablation (CA) while mitigating risk of left atrial appendage (LAA) thrombus. BACKGROUND: CA for atrial fibrillation (AF) plus LAAO is safe and feasible. LAAEI may improve freedom from recurrence in PLAF but may increase LAA thrombus. METHODS: We performed 42 concomitant procedures in patients with PLAF. After standard lesions, LAAEI was performed. LAAO immediately followed ablation. If 3-month transesophageal echocardiogram (TEE) was benign, oral anticoagulation (OAC) was transitioned to dual antiplatelet therapy for 3 more months. RESULTS: Patients were 71.1 ± 8.5 years old, with CHADS2-VASc of 3.3 ± 1.1 and HAS-BLED of 2.5 ± 1.4. Twenty-eight of 42 patients (66.7%) were completely AF free over an average follow-up of 18.6 ± 8.6 months. The AF-free survival estimate was 94.5% at 1 year. There was no thromboembolism (TE) during the follow-up. There were six non-significant leaks acutely and six non-significant leaks at 6 months. There were three device-related thrombi, although 2/3 stopped OAC prematurely. CONCLUSION: A combined procedure is feasible and effective in treating arrhythmia and stroke risk associated with PLAF. The risk of TE despite OAC after LAAEI supports simultaneous LAAO.

Targeted Left Ventricular Lead Implantation Strategy for Non-Left Bundle Branch Block Patients: The ENHANCE CRT Study.

OBJECTIVES: This study compared clinical outcomes between an increased electrical delay in the left ventricular region (QLV)-based LV lead implantation approach (QLV arm) and anatomical implantation approach (control arm) in patients with non-left bundle branch block. BACKGROUND: Limited data exist on cardiac resynchronization therapy effectiveness in patients with non-left bundle branch block. Clinicians generally deliver cardiac resynchronization therapy through an anatomical implantation approach; however, targeting the QLV may serve as an individualized implantation strategy in non-left bundle branch block patients. METHODS: The study enrolled 248 subjects at 29 U.S. centers. Subjects were randomized in a 2:1 ratio between a QLV-based implantation approach and anatomical implantation approach and were implanted with a St. Jude Medical quadripolar cardiac resynchronization therapy defibrillator system. The primary endpoint was the clinical composite score after 12 months of follow-up. RESULTS: The study analyzed 191 available subjects at 12 months of follow-up (128 QLV arm, 63 control arm). Of these, 39 subjects (26 in the QLV arm and 13 in the control arm) had heart failure events (8 cardiac deaths and 31 heart failure hospitalizations). Aside from New York Heart Association functional class, there were no other significant differences in baseline characteristics between the 2 arms. The responder rate at 12 months measured by the clinical composite score was 67.2% in the QLV arm and 73.0% in the control arm (p = 0.506). CONCLUSIONS: Although patient-tailored left ventricular lead placement guided by QLV is promising, we observed no difference in outcome between the QLV-based implantation approach and the conventional anatomical implantation approach.

Vacuum-assisted vegetation removal with percutaneous lead extraction: a systematic review of the literature.

PURPOSE: To perform a systematic review of reports in which the AngioVac™ percutaneous vacuum-assisted aspiration system was successfully used to debulk or remove vegetations prior to percutaneous lead extraction. METHODS: We included all studies and case reports that used a percutaneous aspiration technique for vegetation removal or debulking with percutaneous lead extraction for patients with lead-associated endocarditis. Ten reports and retrospective data from our centers were used, which included a total of 88 patients and 205 leads. RESULTS: The percutaneous aspiration procedure was completely or partially successful in 86 patients (97.7%). The lead extraction procedure itself was successful in 87 patients (98.9%). The aspiration procedure and lead extraction were done concomitantly in 81 patients (92.0%). Four patients (4.5%) had major complications (two due to vascular injuries, one due to coronary sinus injury, and one due to tricuspid valve injury). There were no complications from the aspiration procedure, and no cases were associated with procedure-related mortality. CONCLUSION: While patients with large vegetations have historically been referred for surgical lead extraction, data are lacking in its techniques and outcomes. Existing data suggest that percutaneous vacuum-assisted aspiration for vegetation removal or debulking in endocarditis prior to or concurrent with percutaneous lead extraction has a high success rate with a low complication rate across a broad series of patients.

Association between Arrhythmia and Pulmonary Artery Pressure in Heart Failure Patients Implanted with a Cardiac Defibrillator and Ambulatory Pulmonary Artery Pressure Sensor.

The association between ventricular arrhythmia (VA) burden or defibrillator therapy and pulmonary artery pressure (PAP) has not been characterized in an ambulatory setting; thus, we sought in the present research to determine the relationship between ambulatory PAP and VA burden. A retrospective cohort study involving patients with an implantable cardiac defibrillator and CardioMEMS™ PAP sensor (Abbott Laboratories, Chicago, IL, USA) both transmitting remotely into the Merlin.net™ patient care network (Abbott Laboratories, Chicago, IL, USA) was conducted. VA and therapy burden in the six months following sensor implant were stratified by the baseline mean PAP. Patients with PAPs of 25 mmHg to 35 mmHg and those with PAPs of 35 mmHg or more were compared with individuals with PAPs of less than 25 mmHg. The change in VA burden was reported using the averaged mean PAP reduction during the first three months. A total of 162 patients aged 69.4 years ± 10.9 years were included (74% male) with a baseline mean PAP of 36.2 mmHg ± 10.4 mmHg. Twenty patients with a baseline mean PAP of less than 25 mmHg had no VAs over six months. For 61 patients with a baseline mean PAP of between 25 mmHg and 35 mmHg, the annualized number of days with ventricular tachycardia (VT)/ventricular fibrillation (VF) was 1.65/patient-year (p < 0.001), with 8% of patients having VT/VF events. For 81 patients with a baseline mean PAP of 35 mmHg or more, 19% of patients had a VT/VF event and an annualized number of days with VT/VF events of 1.45/patient-year (p < 0.001). When analyzing the treatment effect, a reduction of 3 mmHg or more in mean PAP over three months reduced arrhythmia burden over the next three months as compared with in patients without such an improvement. In conclusion, it is indicated that VAs are associated with high PAPs, and a reduction in PAP may lead to a reduction in VAs in real-world ambulatory patients.

Single- and dual-site ventricular pacing entirely through the coronary sinus for patients with prior tricuspid valve surgery.

PURPOSE: Transvenous right ventricular pacing has traditionally been avoided after surgical tricuspid valve repair or replacement because of possible valvular dysfunction. Epicardial pacing has been used but it requires surgical thoracotomy and has higher lead failure rates when compared to transvenous pacing. We evaluated the lead stability and clinical outcomes in patients with isolated coronary sinus (CS) lead due to relative contraindication to transvenous pacing from prior tricuspid valve (TV) surgery. METHODS: We retrospectively examined a single-center cohort of 34 patients with TV disease and/or surgery who underwent permanent pacemaker implantation with a left ventricular CS lead as the only ventricular pacing lead (to avoid crossing the TV). The clinical outcome, echocardiographic data, and pacing thresholds were evaluated at follow-up. RESULTS: We implanted 19 patients with a single-CS lead and 15 patients with dual-CS leads. The average left ventricular ejection fraction was 56 ± 13% prior to lead implantation and remained stable at 2-year follow-up. The tricuspid regurgitation remained mild at follow-up. The average lead pacing threshold was 1.2 ± 0.6 V × ms at implant and 1.1 ± 0.4 V × ms at 2-year follow-up (P = 0.39). For patients with dual-CS leads, the pacing threshold was 1.2 ± 0.7 V × ms at implant and 1.1 ± 0.5 V × ms at 2-year follow-up (P = 0.52). CONCLUSIONS: The use of ventricular pacing entirely through the CS is an effective and minimally invasive method that provides stable pacing for patients with prior TV surgery in whom transvenous lead placement either is not possible or is relatively contraindicated.

Anticoagulation Patterns in Patients with Atrial Fibrillation Following Percutaneous Coronary Intervention in an Academic Center.

A common dilemma facing physicians treating patients with atrial fibrillation (AF) who have undergone percutaneous coronary intervention (PCI) is the management of oral anticoagulation (OAC) therapy, because there is also an indication for dual antiplatelet therapy in these patients. The purpose of this study was therefore to evaluate anticoagulation patterns in this patient population in an attempt to identify patterns of risk factors that may influence OAC prescribing habits. This retrospective study entailed a review of a total of 4,648 patients from two academic hospitals who underwent PCI between 2008 and 2016. We ultimately included 211 patients who had AF and an indication for OAC. Chart review revealed patients' risk factors, CHA2DS2-VASc and HAS-BLED scores, and antithrombotic regimens. Only 105 (49.8%) patients who met the indications for OAC were actually placed on OAC post-PCI. There was no significant relationship between discharge on OAC and HAS-BLED score (t = 0.14; p = 0.44) or CHA2DS2-VASc score (t = 0.76; p = 0.22). Patients younger than 65 years of age were prescribed more triple therapy (56% versus 33%; p < 0.01) or any OAC (69% versus 41%; p < 0.01) on discharge in comparison with patients 65 years of age or older. The older patient group had a significantly higher average CHA2DS2-VASc score (4.4 versus 3.2; p < 0.01) and a higher average HAS-BLED score (2.8 versus 2.4; p < 0.01). Ultimately, this study indicated that less than half of AF patients with an indication for OAC were placed on OAC post-PCI. There was no association between discharge on OAC and CHA2DS2-VASc score, HAS-BLED score, or any other individual risk factor, with the exception of age.

Inductionless or limited shock testing is possible in most patients with implantable cardioverter- defibrillators/cardiac resynchronization therapy defibrillators: results of the multicenter ASSURE Study (Arrhythmia Single Shock Defibrillation Threshold Testing Versus Upper Limit of Vulnerability: Risk Reduction Evaluation With Implantable Cardioverter-Defibrillator Implantations).

BACKGROUND: Implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators have relied on multiple ventricular fibrillation (VF) induction/defibrillation tests at implantation to ensure that the device can reliably sense, detect, and convert VF. The ASSURE Study (Arrhythmia Single Shock Defibrillation Threshold Testing Versus Upper Limit of Vulnerability: Risk Reduction Evaluation With Implantable Cardioverter-Defibrillator Implantations) is the first large, multicenter, prospective trial comparing vulnerability safety margin testing versus defibrillation safety margin testing with a single VF induction/defibrillation. METHODS AND RESULTS: A total of 426 patients receiving an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator underwent vulnerability safety margin or defibrillation safety margin screening at 14 J in a randomized order. After this, patients underwent confirmatory testing, which required 2 VF conversions without failure at < or = 21 J. Patients who passed their first 14-J and confirmatory tests, irrespective of the results of their second 14-J test, had their devices programmed to a 21-J shock for ventricular tachycardia (VT) or VF > or = 200 bpm and were followed up for 1 year. Of 420 patients who underwent 14-J vulnerability safety margin screening, 322 (76.7%) passed. Of these, 317 (98.4%) also passed 21-J confirmatory tests. Of 416 patients who underwent 14-J defibrillation safety margin screening, 343 (82.5%) passed, and 338 (98.5%) also passed 21-J confirmatory tests. Most clinical VT/VF episodes (32 of 37, or 86%) were terminated by the first shock, with no difference in first shock success. In all observed cases in which the first shock was unsuccessful, subsequent shocks terminated VT/VF without complication. CONCLUSIONS: Although spontaneous episodes of fast VT/VF were limited, there was no difference in the odds of first shock efficacy between groups. Screening with vulnerability safety margin or defibrillation safety margin may allow for inductionless or limited shock testing in most patients.