Tumescent local anesthesia versus general anesthesia for subcutaneous implantable cardioverter-defibrillator implantation.

BACKGROUND: Subcutaneous implantable cardioverter-defibrillator (S-ICD) is an effective alternative to transvenous implantable cardioverter-defibrillator. General anesthesia (GA) is considered the standard sedation approach because of the pain caused by the manipulation of subcutaneous tissue with S-ICD implantation. However, GA carries several limitations, including additional risk of adverse events, prolonged in-room times, and increased costs. OBJECTIVE: The purpose of this study was to define the effectiveness and safety of tumescent local anesthesia (TLA) in comparison to GA in patients undergoing S-ICD implantation. METHODS: We performed a prospective, nonrandomized, controlled, multicenter study of patients referred for S-ICD implantation between 2019 and 2020. Patients were allocated to either TLA or GA on the basis of patient's preferences and/or anesthesia service availability. TLA was prepared using lidocaine, epinephrine, sodium bicarbonate, and sodium chloride. All patients provided written informed consent, and the institutional review board at each site provided approval for the study. RESULTS: Sixty patients underwent successful S-ICD implantation from July 2019 to November 2020. Thirty patients (50%) received TLA, and the rest GA. There were no differences between groups with regard to baseline characteristics. In-room and procedural times were significantly shorter with TLA (107.6 minutes vs 186 minutes; P < .0001 and 53.2 minutes vs 153.7 minutes; P < .0001, respectively). Pain was reported less frequently by patients who received TLA. The use of opioids was significantly reduced in patients who received TLA (23% vs 62%; P = .002). CONCLUSION: TLA is an effective and safe alternative to GA in S-ICD implantation. The use of TLA is associated with shorter in-room and procedural times, less postprocedural pain, and reduced usage of opioids and acetaminophen for analgesia.

Utility of the Modified Frailty Index to Predict Cardiac Resynchronization Therapy Outcomes and Response.

The aim of the present study was to investigate the utility of the modified frailty index (mFI) to predict outcomes in patients who underwent cardiac resynchronization therapy (CRT) device implantation. A retrospective cohort study of patients undergoing CRT implantation or upgrade over a 5-year period was performed. The relation between the preprocedural 11-component mFI and clinical outcomes including 1-year mortality, periprocedural and 30-day adverse events, 30-day readmission, length of hospitalization after procedure, and response to CRT defined by changes in left ventricular ejection fraction and end-diastolic volume were studied. Of 283 patients studied, 134 (47.3%) were classified as frail (mFI ≥3). Frailty was associated with an increased risk of 1-year mortality (hazard ratio 5.87, p = 0.033 in multivariate analysis), and increased frequency of adverse events (p = 0.013), 30-day readmission (p = 0.0077), and postprocedural length of stay ≥3 days (p = 0.0005). Frail patients had significantly less echocardiographic response to CRT compared with nonfrail patients with change in left ventricular ejection fraction 6% versus 12% (p = 0.004) and change in left ventricular end-diastolic volume -19.9 versus -43.3 ml (p = 0.006). In conclusion, frailty as assessed by the mFI is associated with an increase in 1-year mortality, adverse events, 30-day readmission, length of stay, and poorer response to CRT after implantation.

Risk of thromboembolic events after percutaneous left atrial appendage ligation in patients with atrial fibrillation: Long-term results of a multicenter study.

BACKGROUND: Percutaneous left atrial appendage (LAA) occlusion with Lariat has emerged as a viable alternative to oral anticoagulation (OAC) to prevent thromboembolic (TE) events in patients with atrial fibrillation. OBJECTIVE: We evaluated the long-term TE risk in post-Lariat patients. METHODS: Consecutive patients undergoing LAA ligation with the Lariat device at multiple centers with at least 1-year follow-up were included in the analysis. Transesophageal echocardiography (TEE) was performed at 4 weeks, 6 months, and 12 months to assess the completeness of LAA occlusion. OAC was discontinued if 4-week TEE revealed no device-related thrombus and complete closure of the appendage. Patients remained on 81 mg of aspirin per day after discontinuation of the blood thinner. RESULTS: A total of 306 patients were included in the study (mean age 68.8 ± 11.0 years; mean CHA2DS2-VASc score 3.6 ± 1.7). Four-week TEE revealed leaks in 81 patients (26.5%); all leaks were less than 5 mm in diameter. At 6-month TEE, spontaneous closure of the leak was demonstrated in 21 patients (25.9%), 26 patients (32%) underwent a successful leak closure procedure, and the remaining 34 (42%) patients were placed on OAC. At the median follow-up period of 15.9 ± 9.2 months, 9 TE events (2.9%) were reported: 7 with persistent leak and 2 without any detectable leaks on 2-dimensional TEE (P < .001). CONCLUSION: Complete occlusion of the LAA with the Lariat device was associated with the low rate of TE events at long-term follow-up. However, residual leaks were common after Lariat closure and the stroke rate was significantly higher in patients with incomplete occlusion, even with small leaks.

Use of antimicrobial agent pocket irrigation for cardiovascular implantable electronic device infection prophylaxis: Results from an international survey.

PURPOSE: Survey the usage and application protocol of antimicrobial agent pocket irrigation for cardiovascular implantable electronic device (CIED) infection prophylaxis. BACKGROUND: Local antibiotic usage for CIED infection prophylaxis, in particular pocket irrigation, is a well-known strategy but with little data on its clinical effectiveness. METHODS: An anonymous voluntary online survey was sent to a total of 2,092 arrhythmia-oriented cardiologists in 51 countries (1,490 from the United States). RESULTS: There were 487 responses (response rate 23.3%: U.S. 28.2%, outside of the U.S. 11.1%). Eighty-seven percent of respondents use intraoperative antimicrobial agent pocket irrigation and/or an antimicrobial eluting pouch to reduce CIED infection. Fifty-four percent of respondents believe that it is effective to use an antimicrobial agent pocket irrigation to reduce CIED infection; 33% of respondents are uncertain; a few consider this strategy ineffective (13%) or offered no opinion. Significant differences exist in the practice patterns and beliefs between the U.S. and non-U.S. countries (P < 0.05). Ninety-eight percent of respondents report using the same pocket irrigation protocol for permanent pacemaker versus implantable cardioverter defibrillator. Bacitracin (48%), vancomycin (39%), and a cephalosporin (29%) are the most commonly chosen antibiotics. A majority of the respondents are unaware of the cost of using antimicrobial agent pocket irrigation (69%) and neither are they concerned (67%). CONCLUSION: This international survey suggests that, while there are little clinical data to support or discourage such practice, the usage of antimicrobial agent pocket irrigation for CIED infection prophylaxis is widely used in current practice.

Clinical Implications of Leaks Following Left Atrial Appendage Ligation With the LARIAT Device.

OBJECTIVES: The aim of this study was to evaluate the incidence and clinical implications of leaks (acute incomplete occlusion, early and late reopenings) following LAA ligation with the LARIAT device. BACKGROUND: Percutaneous LAA ligation with the LARIAT device may represent an alternative for stroke prevention in high-risk patients with atrial fibrillation with contraindications to oral anticoagulation. METHODS: This was a retrospective, multicenter study of 98 consecutive patients undergoing successful LAA ligation with the LARIAT device. Leaks were defined as the presence of flow as evaluated by transesophageal echocardiography (TEE). TEE was performed during the procedure, at 6 and 12 months, and after thromboembolic events. RESULTS: Leaks were detected in 5 (5%), 14 (15%), and 19 (20%) patients at the 3 time points. During follow-up, 5 patients developed neurological events (4 strokes and 1 transient ischemic attack). Two occurred early (1 fatal stroke and 1 stroke with multiple recurrences in the following months), and TEE was not repeated after the events. The remaining 3 occurred late (after 6 months) and were associated with small leaks (<5 mm). In 2 of 3 cases, such a small leak was missed by the standard evaluation on 2-dimensional TEE, being evident only with the aid of 3-dimensional imaging. CONCLUSIONS: Incomplete occlusion of the LAA after LARIAT ligation is relatively common and may be associated with thromboembolic events. Proper long-term surveillance with careful TEE should be considered to detect leaks, which can be managed with either resumption of oral anticoagulation or percutaneous transcatheter closure.

Clinical Impact of Heparin Kinetics During Catheter Ablation of Atrial Fibrillation: Meta-Analysis and Meta-Regression.

INTRODUCTION: Appropriate activated clotting time (ACT) during catheter ablation of atrial fibrillation (CA-AF) is essential to minimize periprocedural complications. METHODS AND RESULTS: An electronic search was performed using major databases. Outcomes were thromboembolic (TE) and bleeding complications according to ACT levels (seconds). Heparin dose (U/kg) and time (minutes) to achieve the target ACT was compared among patients receiving vitamin K antagonist (VKA) versus non-VKA oral anticoagulants (NOAC). Nineteen studies involving 7,150 patients were identified. Patients with ACT > 300 had less TE (OR, 0.51; 95% CI 0.35-0.74) and bleeding (OR, 0.70; 95% CI 0.60-0.83) compared to ACT < 300, when using any type of oral anticoagulation. The use of VKA was associated with reduced heparin requirements (mean dose: 157 U/kg vs. 209 U/kg, P < 0.03; SDM -0.86 [95% CI -1.39 to -0.33]), and with lower time to achieve the target ACT (mean time: 24 minutes vs. 49 minutes, P < 0.03; SDM -11.02 [95% CI -13.29 to -8.75]) compared to NOACs. No significant publication bias was found. CONCLUSIONS: Performing CA-AF with a target ACT > 300 decreases the risk of TE without increasing the risk of bleeding. Patients receiving VKAs required less heparin and reached the target ACT faster compared to NOACs.

Giant Left Ventricular Pseudoaneurysm and Myocardial Dissection as a Complication of Multiple Ventricular Tachycardia Ablations in a Patient with Cardiac Sarcoidosis.

Late development of left ventricular (LV) pseudoaneurysms after ventricular tachycardia (VT) catheter ablation is a rare phenomenon, and very few cases have been reported in the medical literature. We describe the case of a giant LV pseudoaneurysm as a late complication of multiple epicardial and endocardial VT ablations in a female in her 50s with known cardiac sarcoidosis.

Referral Patterns for Primary Prophylaxis Implantable Cardioverter Defibrillator Therapy for an Urban US Population.

Implantable cardioverter defibrillators (ICDs) have been demonstrated to improve survival for both primary and secondary prevention of sudden cardiac arrest. However, studies suggest that ICD therapy is underused in appropriate candidates. Sex and racial disparities in ICD use have been suggested. We sought to characterize the referral patterns of high-risk patients for the primary prophylaxis of sudden cardiac arrest at a tertiary academic medical center serving a diverse population in an urban US setting. Electronic hospital databases were retrospective reviewed for patients meeting criteria for prophylactic ICD implantation. We evaluated the association of gender, age, race, and primary language with the referral and subsequent implantation of an ICD. We identified 1,055 patients satisfying prophylactic ICD criteria: 600 men, mean age 62.6 years, 27.6% black, 19.3% white, 23.3% Hispanic, and 49.8% primary language of English. Of the 673 patients (63.7%) referred for ICD evaluation, 345 underwent implantation, 125 declined, and 203 had significant co-morbidities that precluded implantation. Gender, race, and primary language were not associated with referral for ICD or with decision to proceed with implantation. Patients of increased age were less likely to be referred for ICD and were more likely to refuse implantation. ICD therapy was not considered in 146 patients eligible for prophylactic implantation. In conclusion, referral rates for ICD consideration were higher at our institution than in previous reports. Nonetheless, 14% of appropriate patients were not considered. This argues for the importance of increased education for patients and referring physicians.

The Prognostic Value of Early Repolarization with ST-Segment Elevation by Age and Gender in the Hispanic Population.

BACKGROUND: Early repolarization (ER), once thought to be a benign finding on electrocardiograph (ECG), has recently been associated with an increased risk of sudden cardiac death. As there are limited data in the Hispanic population, we investigated possible associations between automated ECG ER readings and overall mortality, using the classic definition involving J-point elevation with ST segment elevation. METHODS: An ECG and electronic medical record (EMR) database from a regional medical center was interrogated. Inclusion criteria included Hispanic ethnicity and age over 18 from 2000 to 2011. A Cox model assessed the outcome of death. Varying morphological characteristics of ER were analyzed for high-risk features. RESULTS: There were n = 33,944 Hispanics of who n = 532 (1.6%) had ER with a mean follow-up period of 5.29 years. After adjustment for demographic, clinical, lifestyle, and laboratory variables, ER was not significantly related to all-cause mortality (hazard ratio [HR]: 1.18, 95% confidence interval [CI]: 0.90-1.54, P = 0.23). However, mortality risk of ER varied by gender and age (P interaction = 0.007). The risk of ER for mortality was highest for females (HR: 2.01, CI: 1.39-3.10, P = 0.001), with the highest overall risk for women over the age of 75 (HR: 2.09, CI: 1.12-3.92, P = 0.021) compared to women under age 75 (HR: 1.72, CI: 0.95-3.11, P = 0.075). CONCLUSIONS: ER is not associated with an increased risk of death in the overall Hispanic population. However, our analysis suggests a higher risk of overall mortality in the elderly Hispanic female population with ER.

Left Atrial Appendage Occlusion Device and Novel Oral Anticoagulants Versus Warfarin for Stroke Prevention in Nonvalvular Atrial Fibrillation: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Nonvalvular atrial fibrillation is the most common arrhythmia. Patients with nonvalvular atrial fibrillation are at increased risk of stroke; therefore, we evaluated the efficacy and safety of different approaches to prevent this major complication. METHODS AND RESULTS: We conducted electronic database searches of phase III randomized controlled trials. The groups were novel oral anticoagulants, Watchman left atrial appendage occlusion device (DEVICE), and warfarin. Efficacy outcomes were stroke or systemic embolism, and all-cause mortality. Safety outcome was major bleeding and procedure-related complications. A subgroup analysis of the elderly population was done. We used random-effects model to compare pooled outcomes and tested for heterogeneity. Odds ratios (ORs) and 95% confidence intervals (CIs) were computed for each outcome. Seven randomized controlled trials (n=73,978) were included. There was a significant difference favoring novel oral anticoagulants for systemic embolism (OR, 0.84; 95% CI, 0.72-0.97; P=0.01), all-cause mortality (OR, 0.89; 95% CI, 0.84-0.94; P<0.001), and safety outcomes (OR, 0.79; 95% CI, 0.65-0.97; P=0.026) compared with warfarin. No difference was seen between DEVICE and warfarin for efficacy end points; however, DEVICE had more complications (OR, 1.85; 95% CI, 1.14-3.01; P=0.012). In the elderly (6 randomized controlled trials, n=30,699), systemic embolism was favored with novel oral anticoagulants over warfarin (OR, 0.77; 95% CI, 0.68-0.87; P≤0.001). No evidence of significant publication bias was found. CONCLUSIONS: Novel oral anticoagulants is superior to warfarin for stroke prevention in nonvalvular atrial fibrillation. This benefit was also observed in the elderly population. DEVICE is a reasonable noninferior alternative to warfarin for stroke prevention, but cautious use is essential given safety concerns.

Methadone Therapy in Underserved Urban Community: QTc Prolongation and Life-Threatening Ventricular Arrhythmias.

AIMS: Methadone has been associated with QTc prolongation and ventricular arrhythmias but the prevalence of QTc prolongation and association with ventricular arrhythmias remains unclear. We investigated this in our inner city urban community (Bronx, New York) that has a large number of patients on methadone. METHODS: Telemetry records, nursing documentation and electronic charts of 291 patients spanning856 encounters were evaluated. QT was manually measured from ECG utilizing standardized QT measurement guidelines and was corrected for heart rate using Hodges formula. QTc >470 ms in males and >480 ms in females was considered to be prolonged. RESULTS: Patients had prolonged QTc, QTc >500 ms and ventricular arrhythmias during 25.6%, 14.1% and 3.4% of encounters, respectively. There was a very weak dose dependent relationship between methadone dose and QTc (Spearman's rho = 0.09).In addition to methadone, patients were on at least one QT prolonging drugs during 39% of the encounters. Patients who were receiving two interacting drugs in addition to methadone had the highest prevalence (29%) of QTc prolongation. CONCLUSION: Although the prevalence of QTc prolongation among patients on methadone therapy is high, the prevalence of ventricular arrhythmia is relatively low. Hospitalized patients on sustained methadone therapy are frequently on multiple additional QTc prolonging drugs. There is no significant dose dependent relationship between methadone dose and QTc. However, the concurrent use of methadone and interacting drugs lead to an increased prevalence of QTc prolongation.

Prognostic value of automatically detected early repolarization.

Early repolarization associated with sudden cardiac death is based on the presence of >1-mm J-point elevations in inferior and/or lateral leads with horizontal and/or downsloping ST segments. Automated electrocardiographic readings of early repolarization (AER) obtained in clinical practice, in contrast, are defined by ST-segment elevation in addition to J-point elevation. Nonetheless, such automated readings may cause alarm. We therefore assessed the prevalence and prognostic significance of AER in 211,920 patients aged 18 to 75 years. The study was performed at a tertiary medical center serving a racially diverse urban population with a large proportion of Hispanics (43%). The first recorded electrocardiogram of each individual from 2000 to 2012 was included. Patients with ventricular paced rhythm or acute coronary syndrome at the time of acquisition were excluded from the analysis. All automated electrocardiographic interpretations were reviewed for accuracy by a board-certified cardiologist. The primary end point was death during a median follow-up of 8.0 ± 2.6 years. AER was present in 3,450 subjects (1.6%). The prevalence varied significantly with race (African-Americans 2.2%, Hispanics 1.5%, and non-Hispanic whites 0.9%, p <0.01) and gender (male 2.4% vs female 0.6%, p <0.001). In a Cox proportional hazards model controlling for age, smoking status, heart rate, QTc, systolic blood pressure, low-density lipoprotein cholesterol, body mass index, and coronary artery disease, there was no significant difference in mortality regardless of race or gender (relative risk 0.98, 95% confidence interval 0.89 to 1.07). This was true even if J waves were present. In conclusion, AER was not associated with an increased risk of death, regardless of race or gender, and should not trigger additional diagnostic testing.

Rate of cardiovascular implantable electronic device (CIED) re-extraction after recurrent infection.

BACKGROUND: Patients who develop a cardiovascular implantable electronic device (CIED) infection requiring extraction may have risk factors that make them prone to developing another infection of the reimplanted CIED. However, the rate of a second infection requiring repeat extraction in such patients is unknown and may have important clinical implications. METHODS: We retrospectively reviewed all patients at our institution from January 2001 to October 2012 who underwent a CIED extraction for an infection and then required reimplantation. We then reviewed the incidence of a repeat extraction due to a second infection. Clinical and device parameters at the time of the second infection were retrieved. RESULTS: There were 168 patients who underwent a CIED extraction because of infection and were subsequently reimplanted. The median time to reimplantation was 3 [1(st) quartile: 1, 3(rd) quartile: 10] days. After a mean follow-up of 4.4 ± 2.7 years, nine (5.4%) patients underwent a repeat CIED extraction due to a second infection. Six repeat extractions (67%) occurred in the first year, leading to an event rate of 3.9% within 1 year of reimplantation. Patients with a second infection requiring a repeat CIED extraction were younger (57 ± 20 vs 68 ± 16, P = 0.046). Pocket infection was the most common presentation of a second infection, occurring in eight of the nine patients. CONCLUSION: The rate of a second infection leading to a CIED repeat extraction is elevated within the first year after reimplantation. To determine predictors of recurring infection, analysis of a larger multicenter series is warranted.

Impact of metabolic syndrome on the risk of atrial fibrillation recurrence after catheter ablation: systematic review and meta-analysis.

PURPOSE: The impact of metabolic syndrome (MetS) on recurrence of atrial fibrillation (AF) after catheter ablation remains uncertain. We conducted a meta-analysis to summarize the relative risks (RR) of AF recurrence after catheter ablation in patients with vs. without MetS and its components. METHODS: Among 839 articles identified from PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials, we included 23 studies with a total of 12,924 patients (7,594 with paroxysmal AF and 5,330 with nonparoxysmal AF) for analysis. Five of these had complete information on MetS components. Variables assessed comprised study design and population characteristics, AF ablation methods, use of anti-arrhythmic drugs, AF recurrence ascertainment methods, adjustment variables, and other quality indicators. RESULTS: Our meta-analysis found an elevated risk of AF recurrence after ablation in patients with vs. without MetS (pooled RR, 1.63; 95 % confidence interval (CI), 1.25-2.12). Among components of MetS, hypertension was a predictor of AF post-ablation recurrence in studies without adjustment for other MetS components (RR, 1.62; 95 % CI, 1.23-2.13) but not in those adjusting for two or more additional MetS components (RR, 1.03; 95 % CI, 0.88-1.20). There was a borderline association between overweight/obesity and AF recurrence after ablation (RR, 1.27; 95 % CI, 0.99-1.64). CONCLUSIONS: MetS is associated with an increased risk of AF recurrence after catheter ablation. Further study of the MetS and its components as determinants of AF risk could help refine patient selection and improve procedural outcomes.

Subclavian venoplasty may reduce implant times and implant failures in the era of increasing device upgrades.

BACKGROUND: The incidence of subclavian venous occlusions (SCVOs) may be an increasing problem in the era of device upgrades, especially to cardiac resynchronization therapy. Venoplasty (VP) performed by the electrophysiologist as a way of managing SCVOs may be advantageous. METHODS: We reviewed the implantable cardioverter defibrillator (ICD) implants of the past 5 years at Montefiore Medical Center and searched for SCVOs that required intervention and compared cases where VP was performed with cases where it was not. RESULTS: Of 1,853 ICD implants, 41 SCVOs (2.2%) requiring intervention were identified. Its incidence increased seven-fold from 0.7% in 2005 to 5.2% in 2009. Twenty-seven of the 41 SCVOs were found during a device upgrade. Of these 41 SCVOs, 18 underwent VP and 23 did not. In the VP group, there was a trend towards a shorter total procedure time, 2:31 hours versus 3:28 hours (P=0.37), and the total fluoroscopy time was 30 minutes versus 27 minutes (P=0.55). VP was successful in all 18 patients. Among the non-VP group (n=23), five (21.5%) had a failed implantation because of the inability to gain venous access and 10 (42.7%) had to be implanted on the contralateral side. CONCLUSION: The incidence of SCVOs requiring intervention is increasing in the era of device upgrades. VP performed by an electrophysiologist appears to be a safe and efficient approach to manage these SCVOs. VP seems to reduce the implant time and the need to implant on the other side as well as implant failure due to the inability to gain venous access.