Association between high-density mapping of atypical atrial flutter, clinical outcomes and healthcare utilization.

BACKGROUND: Success of atypical atrial flutter (AAFL) ablation has historically been limited by difficulty mapping the complex re-entrant circuits involved. While high-density (HD) mapping has become commonplace in clinical practice, there are limited data on outcomes of HD versus non-HD mapping for AAFL ablation. OBJECTIVE: To compare clinical outcomes and healthcare utilization using HD mapping versus non-HD mapping for AAFL ablation. METHODS: Retrospective analysis of all AAFL procedures between 2005 and 2022 at an academic medical center was conducted. Procedures utilizing a 16-electrode HD Grid catheter and Precision mapping system were compared to procedures using prior generation 10-20 electrode spiral catheters and the Velocity system (Abbott, IL). Cox regression models and Poisson regression models were utilized to examine procedural and healthcare utilization outcomes. Models were adjusted for left ventricular ejection fraction, CHA2DS2-VASc, and history of prior ablation. RESULTS: There were 108 patients (62% HD mapping) included in the analysis. Baseline clinical characteristics were similar between groups. Use of HD mapping was associated with a higher rate of AAFL circuit delineation (92.5% vs. 76%; p = .014) and a greater adjusted procedure success rate, defined as non-inducibility at procedure end, (aRR (95% CI) 1.26 (1.02-1.55) p = .035) than non-HD mapping. HD mapping was also associated with a lower rate of ED visits (aIRR (95% CI) 0.32 (0.14-0.71); p = .007) and hospitalizations (aIRR (95% CI) 0.32 (0.14-0.68); p = .004) for AF/AFL/HF through 1 year. While there was a lower rate of recurrent AFL through 1 year among HD mapping cases (aHR (95% CI) 0.60 (0.31-1.16) p = .13), statistical significance was not met likely due to the low sample size and higher rate of ambulatory rhythm monitoring in the HD group (61% vs. 39%, p = .025). CONCLUSION: Compared to non-HD mapping, AAFL ablation with HD mapping is associated with improvements in the ability to define the AAFL circuit, greater procedural success, and a reduction in the number of ED visits and hospitalization for AF/AFL/HF.

Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: Analysis of All Appropriate Therapy in the PRAETORIAN Trial.

BACKGROUND: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) showed noninferiority of subcutaneous implantable cardioverter defibrillator (S-ICD) compared with transvenous implantable cardioverter defibrillator (TV-ICD) with regard to inappropriate shocks and complications. In contrast to TV-ICD, S-ICD cannot provide antitachycardia pacing for monomorphic ventricular tachycardia. This prespecified secondary analysis evaluates appropriate therapy and whether antitachycardia pacing reduces the number of appropriate shocks. METHODS: The PRAETORIAN trial was an international, investigator-initiated randomized trial that included patients with an indication for implantable cardioverter defibrillator (ICD) therapy. Patients with previous ventricular tachycardia <170 bpm or refractory recurrent monomorphic ventricular tachycardia were excluded. In 39 centers, 849 patients were randomized to receive an S-ICD (n=426) or TV-ICD (n=423) and were followed for a median of 49.1 months. ICD programming was mandated by protocol. Appropriate ICD therapy was defined as therapy for ventricular arrhythmias. Arrhythmias were classified as discrete episodes and storm episodes (≥3 episodes within 24 hours). Analyses were performed in the modified intention-to-treat population. RESULTS: In the S-ICD group, 86 of 426 patients received appropriate therapy, versus 78 of 423 patients in the TV-ICD group, during a median follow-up of 52 months (48-month Kaplan-Meier estimates 19.4% and 17.5%; P=0.45). In the S-ICD group, 83 patients received at least 1 shock, versus 57 patients in the TV-ICD group (48-month Kaplan-Meier estimates 19.2% and 11.5%; P=0.02). Patients in the S-ICD group had a total of 254 shocks, compared with 228 shocks in the TV-ICD group (P=0.68). First shock efficacy was 93.8% in the S-ICD group and 91.6% in the TV-ICD group (P=0.40). The first antitachycardia pacing attempt successfully terminated 46% of all monomorphic ventricular tachycardias, but accelerated the arrhythmia in 9.4%. Ten patients with S-ICD experienced 13 electrical storms, versus 18 patients with TV-ICD with 19 electrical storms. Patients with appropriate therapy had an almost 2-fold increased relative risk of electrical storms in the TV-ICD group compared with the S-ICD group (P=0.05). CONCLUSIONS: In this trial, no difference was observed in shock efficacy of S-ICD compared with TV-ICD. Although patients in the S-ICD group were more likely to receive an ICD shock, the total number of appropriate shocks was not different between the 2 groups. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.

Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial. METHODS AND RESULTS: The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections, and the need for invasive interventions. Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group, 49 complications occurred in 44 patients of which lead dysfunction was most frequent (HR: 0.69; P = 0.11). In both groups, half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047). CONCLUSION: This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice.

Esophageal temperature management during cryoballoon ablation for atrial fibrillation.

INTRODUCTION: Esophageal thermal injury (ETI) is a well-recognized complication of atrial fibrillation (AF) ablation. Previous studies have demonstrated that direct esophageal cooling reduces ETI during radiofrequency AF ablation. The purpose of this study was to evaluate the use of an esophageal warming device to prevent ETI during cryoballoon ablation (CBA) for AF. METHODS: This prospective, double-blinded study enrolled 42 patients with symptomatic AF undergoing CBA. Patients were randomized to the treatment group with esophageal warming (42°C) using recirculated water through a multilumen, silicone tube inserted into the esophagus (EnsoETM®; Attune Medical) (WRM) or the control group with a luminal single-electrode esophageal temperature monitoring probe (LET). Patients underwent upper endoscopy esophagogastroduodenoscopy (EGD) the following day. ETI was classified into four grades. RESULTS: Baseline patient characteristics were similar between groups. Procedural characteristics including number of freezes, total freeze time, early freeze terminations, coldest balloon temperature, procedure duration, posterior wall ablation, and proton pump inhibitor and transesophageal echocardiogram use before procedure were not different between groups. The EGD was completed in 40/42 patients. There was significantly more ETI in the WRM group compared to the LET group (n = 8 [38%] vs. n = 1 [5%], p = 0.02). All ETI lesions were grade 1 (erythema) or 2 (superficial ulceration). Total freeze time in the left inferior pulmonary vein was predictive of ETI (360 vs. 300 s, p = 0.03). CONCLUSION: Use of a luminal heat exchange tube for esophageal warming during CBA for AF was paradoxically associated with a higher risk of ETI.

Impact of pre-ablation weight loss on the success of catheter ablation for atrial fibrillation.

INTRODUCTION: Obesity is an established risk factor for recurrent atrial fibrillation (AF) after ablation. The impact of pre-procedure weight changes on freedom from AF (FFAF) after ablation in obese and nonobese patients is unknown. METHODS: A single-center retrospective cohort study of patients undergoing pulmonary vein isolation was performed. Before ablation, all candidates were encouraged to adopt healthy lifestyle habits according to American Heart Association guidelines, including weight loss, by their physician. The primary endpoint was FFAF through 1-year after completion of the 3-month blanking period. RESULTS: Of the 601 patients (68% male; average age 62.1 ± 10.3 years) included in analysis, 234 patients (38.9%) were obese (body mass index ≥ 30) and 315 (52.4%) had paroxysmal AF. FFAF was observed in 420 patients (69.9%) at 15 months. Percent change in weight that occurred during the year before ablation independently predicted FFAF through 15-months in all patients (adjusted odds ratio = 1.17, 95% confidence interval: 1.11-1.23). Subgroup analyses based on paroxysmal vs persistent AF, presence of obesity, and history of prior ablation were performed. Percent change in weight over the year before ablation was independently associated with FFAF in all subgroups except nonobese patients with persistent AF. CONCLUSION: Pre-ablation weight loss was associated with FFAF in both obese and nonobese patients. Further studies are needed to define the optimal approach to weight loss before AF ablation.

Patient-reported outcomes after cryoballoon ablation are equivalent between moderate sedation and general anesthesia.

INTRODUCTION: Moderate sedation (MS) during cryoballoon ablation (CBA) avoids risks of general anesthesia (GA) and improves electrophysiology (EP) lab throughput. However, one barrier to the use of MS is the potential for patient discomfort. The objective of this study was to compare patient-reported outcome measures following CBA for paroxysmal atrial fibrillation (pAF) under MS and GA. METHODS AND RESULTS: Consecutive patients undergoing a first CBA for pAF under GA or MS were prospectively enrolled. The sedation method was assigned based on patient and provider preference, and perceived airway risk. The primary outcomes were quality of recovery (measured using a validated 40 question survey; QoR-40) and likelihood to recommend (LTR) the procedure and sedation method (measured by Likert scale). Secondary outcomes were acute pulmonary vein (PV) isolation rate, procedure, fluoroscopy and ablation times, and complication rates. Forty-seven GA and 53 MS patients were included. The mean age was 64.9 ± 9.4 years and mean CHA2 DS2 -VASc score was 2.0 ± 1.4. QoR-40 scores were 184.6 ± 16.4 for GA and 187.6 ± 10.2 for MS (P = .28). LTR responses were similar between groups. Mean procedure times were 148.2 ± 56.0 minutes for GA and 129.4 ± 31.4 minutes for MS (P = .038). Fluoroscopy and ablation times were similar between groups. A total of 100% (409/409) of PVs were acutely isolated. One hemopericardium occurred in the MS group requiring pericardiocentesis. CONCLUSION: MS for CBA offers an alternative to GA that is safe and well-tolerated by patients with comparable success rates and improved EP lab throughput.

Repeat pulmonary vein isolation with or without FIRM-guided ablation for recurrent atrial fibrillation with pulmonary vein reconnection.

INTRODUCTION: Focal impulse and rotor modulation (FIRM) ablation can be used to target nonpulmonary vein (PV) sources of atrial fibrillation (AF). No published studies have compared freedom from atrial fibrillation (FFAF) after pulmonary vein reisolation (PVRI) plus FIRM to PVRI alone in patients with reconnected PVs undergoing repeat ablation. METHODS: A 3:1 matched retrospective cohort study was performed on 21 patients with recurrent AF and PV reconnection who underwent PVRI plus FIRM-guided ablation and 63 patients with recurrent AF treated with PVRI alone at a single institution. All patients in the PVRI-alone cohort had cryoballoon PVRI at the time of repeat ablation without additional lesion sets for AF. Cases were matched based on the type of AF (paroxysmal vs nonparoxysmal), left atrial diameter (±4 mm), left ventricular ejection fraction (±10%), duration of AF (±18 months), and age (±5 years). The primary endpoint was FFAF after a 3-month blanking period. RESULTS: Out of 53 total FIRM cases performed at Northwestern Memorial Hospital between 2015 and 2017, 21 patients had PVRI plus FIRM for recurrent AF with PV reconnection. These patients had an average of 3.3 ± 2.1 rotors (60% left atrial) ablated. Over a median follow-up time of 24.7 months (interquartile range, 13-36 months), patients in the PVRI-alone cohort demonstrated a higher rate of FFAF (n = 35; 55.6%) than patients in the PVRI plus FIRM-guided ablation cohort (n = 7; 33.3%) (logrank P = .049). CONCLUSION: In patients undergoing repeat ablation for AF with PV reconnection, PVRI plus FIRM did not increase FFAF compared to PVRI alone.

Patient characteristics as predictors of recurrence of atrial fibrillation following cryoballoon ablation.

BACKGROUND: While several studies have evaluated predictors for atrial fibrillation (AF) recurrence following catheter ablation, there are limited data specific to cryoballoon ablation (CBA). METHODS: We analyzed a prospective registry of patients at a single institution who underwent CBA. Recurrence of AF (RAF) was defined as recurrence of AF by 12-month follow-up, excluding the 3-month blanking period. Univariate analysis was performed to evaluate predictors of RAF. Receiver operating characteristic analysis was used to compare and evaluate the performance of various risk scores for discriminating risk of RAF. RESULTS: There were 542 patients included in the analysis with mean age 61.3 ± 10.6 years, 67.9% male, and 51.6% paroxysmal AF (PAF). Overall, only left atrial diameter (LAD) > 40 mm and ERAF (early recurrence of AF within 0-3 month blanking period) were significant predictors of RAF. In the PAF specific subgroup, LAD > 40 mm, AF duration > 12 months, prior stroke or transient ischemic attack, ERAF, and having previously failed an antiarrhythmic drug were significant predictors of RAF. In persistent AF (PeAF) subgroup, obstructive sleep apnea (OSA) and ERAF were significant predictors of RAF. Out of clinical risk scores tested, BASEAF2 had the highest performance with area under the curve of 0.646 (95% confidence interval [0.548, 0.708]; P < .01). CONCLUSIONS: In this single-center retrospective study of CBA, we found only LAD > 40 mm and ERAF to be predictors of RAF. We identified OSA as a potential targetable risk factor in PeAF patients undergoing CBA. Out of risk scores tested for discriminating risk of RAF, BASEAF2 had the best performance.

Early Cardioversion in Atrial Fibrillation: Earlier Is Better, but Not Always and (Maybe) Not Immediately.

Atrial fibrillation (AF) is the most common cardiac arrhythmia in humans. One of its important features is the tendency to become more persistent over time, even in the absence of underlying progressive heart disease. Conversion and maintenance of sinus rhythm by pharmacological or electrical methods become increasingly difficult the longer the arrhythmia persists. Electrical, mechanical, structural, and autonomic remodeling processes have been implicated in the mechanisms of AF initiation, perpetuation, and progression. Prevention or reversal of these remodeling processes can halt the progression of the disease. Cardioversion is a powerful tool and rhythm control is a widely used strategy in the management of AF. However, important questions remain unanswered regarding not only if, but also when to perform cardioversion. There are observations from past trials and clinical situations that support attempting to restore sinus rhythm, but further prospective randomized clinical trials are needed. Optimal timing of cardioversion remains somewhat uncertain, but it appears to be some time after the first few hours and before the first few months: the earlier, the better, but not always, and maybe not immediately, and it has to be tailored to the clinical situation and its many variables. This review is intended to summarize the evidence supporting early intervention for the prevention of remodeling in patients with AF.

Moderate Sedation Reduces Lab Time Compared to General Anesthesia during Cryoballoon Ablation for AF Without Compromising Safety or Long-Term Efficacy.

BACKGROUND: Cryoballoon ablation (CBA) for paroxysmal atrial fibrillation (pAF) can be performed under general anesthesia (GA) or moderate sedation (MS). Our objective was to compare the effectiveness, safety, procedure duration, and time spent in the electrophysiology (EP) laboratory for CBA performed under GA and MS. METHODS: Patients undergoing a first CBA for pAF were identified. Patients received either GA administered by an anesthesiologist or MS with midazolam and fentanyl administered by EP laboratory staff. Total time in laboratory (sum of procedure and nonprocedure time); fluoroscopy time; freedom from documented AF, atrial flutter, and atrial tachycardia (FFAF); acute pulmonary vein isolation (PVI) rate; and 30-day complication rate were assessed. RESULTS: A total of 55 patients received GA and 119 patients received MS. PVI success rate was 100% in GA and 98.1% in MS (P = 0.04). Total laboratory time was longer for GA (280.4 ± 54.1 minutes vs 245.5 ± 54.7 minutes; P < 0.001), related to longer nonprocedure time (92.2 ± 28.8 minutes GA vs 71.0 ± 30.0 minutes MS; P < 0.001), but not procedure time (188.3 ± 49.3 minutes GA vs 174.5 ± 50.2 minutes MS; P = 0.09). FFAF was not significantly different over a median follow-up duration of 0.9 (interquartile range 0.4-1.9) years (61.8% GA vs 63.0% MS; log-rank P = 0.90). There was no significant difference in complication rate. CONCLUSION: Compared to GA, MS during CBA for pAF was independently associated with shorter total EP laboratory time without compromising FFAF or complication rates.

Cryoballoon versus radiofrequency catheter ablation for paroxysmal atrial fibrillation.

BACKGROUND: Catheter ablation is an established treatment for atrial fibrillation (AF). Cryoballoon ablation (CBA) has emerged as an alternative to radiofrequency ablation (RFA). However, there are few data comparing these modalities for treatment of paroxysmal AF (pAF) in the U.S. POPULATION: The purpose of this study was to compare procedural times, safety, and efficacy of CBA against RFA. METHODS: A single-center prospective cohort study evaluated patients who underwent catheter ablation for pAF using CBA or RFA between January 1, 2010 and October 31, 2013. Patients with prior ablation and those without rhythm follow-up for at least 3 months were excluded. The primary end point was freedom from AF, atrial flutter, and atrial tachycardia (FFAF) >30 seconds after a 3-month blanking period without requirement for antiarrhythmic drugs. We also compared rates of successful pulmonary vein isolation (PVI), fluoroscopy and procedure times, and major complication rates. RESULTS: A total of 201 patients were included (CBA = 101, RFA = 100). The rate of successful PVI was 99.3% in CBA versus 97.4% in RFA (P = 0.08). Procedure times were shorter with CBA (192.9 ± 44.0 minutes vs 283.7 ± 78.0 minutes, P < 0.001) as well as total fluoroscopy times (46.0 ± 22.4 minutes vs 73.0 ± 30.1 minutes, P < 0.001). Overall complication rates were equivalent; however, fewer cardiac perforations occurred with CBA (0% vs 4%, P = 0.042). The 1-year FFAF rates were 60.3% for CBA and 61.1% for RFA (log rank P = 0.93). CONCLUSION: CBA was associated with equivalent 1-year FFAF rate as RFA for pAF. Procedure and fluoroscopy times were shorter for CBA and fewer cardiac perforations occurred.

Validation of the SCALE-CryoAF risk model to predict very late return of atrial fibrillation after cryoballoon ablation.

BACKGROUND: To date, few risk models have been validated to predict recurrent atrial fibrillation (AF) >1 year after ablation. The SCALE-CryoAF score was previously derived to predict very late return of AF (VLRAF) >1 year following cryoballoon ablation (CBA), with strong predictive ability. In this study, we aim to validate the SCALE-CryoAF score for VLRAF after CBA in a novel patient cohort. METHODS: Retrospective analysis of a prospectively maintained single-center database was performed. Inclusion criteria were pulmonary vein isolation using CBA 2017-2020. Exclusion criteria included prior ablation, <1-year follow-up, lack of pre-CBA echocardiogram, additional ablation lesion sets, and documented AF recurrence 90-365 days post-CBA. The area under the curve (AUC) of SCALE-CryoAF was compared to the derivation value and other established risk models. RESULTS: Among 469 CBA performed, 241 (61% male, 62.8 ±11.7 years old) cases were included in analysis. There were 37 (15.4%) patients who developed VLRAF. Patients with VLRAF had a higher SCALE-CryoAF score (VLRAF 5.4 ± 2.7; no VLRAF 3.1 ± 2.9; p<0.001). SCALE-CryoAF was linearly associated with VLRAF (y=14.35x-11.72, R2=0.99), and a score > 5 had a 32.7% risk of VLRAF. The SCALE-CryoAF risk model predicted VLRAF with an AUC of 0.74, which was similar to the derivation value (AUCderivation: 0.73) and statistically superior to MB-LATER, CHA2DS2-VASc, and CHADS2 scores. CONCLUSIONS: The current analysis validates the ability of SCALE-CryoAF to predict VLRAF after CBA in a novel patient cohort. Patients with a high SCALE-CryoAF score should be monitored closely for recurrent AF >1 year following CBA.

Risk of Adverse Outcomes Associated With Cardiac Sarcoidosis Diagnostic Schemes.

BACKGROUND: Multiple cardiac sarcoidosis (CS) diagnostic schemes have been published. OBJECTIVES: This study aims to evaluate the association of different CS diagnostic schemes with adverse outcomes. The diagnostic schemes evaluated were 1993, 2006, and 2017 Japanese criteria and the 2014 Heart Rhythm Society criteria. METHODS: Data were collected from the Cardiac Sarcoidosis Consortium, an international registry of CS patients. Outcome events were any of the following: all-cause mortality, left ventricular assist device placement, heart transplantation, and appropriate implantable cardioverter-defibrillator therapy. Logistic regression analysis evaluated the association of outcomes with each CS diagnostic scheme. RESULTS: A total of 587 subjects met the following criteria: 1993 Japanese (n = 310, 52.8%), 2006 Japanese (n = 312, 53.2%), 2014 Heart Rhythm Society (n = 480, 81.8%), and 2017 Japanese (n = 112, 19.1%). Patients who met the 1993 criteria were more likely to experience an event than patients who did not (n = 109 of 310, 35.2% vs n = 59 of 277, 21.3%; OR: 2.00; 95% CI: 1.38-2.90; P < 0.001). Similarly, patients who met the 2006 criteria were more likely to have an event than patients who did not (n = 116 of 312, 37.2% vs n = 52 of 275, 18.9%; OR: 2.54; 95% CI: 1.74-3.71; P < 0.001). There was no statistically significant association between the occurrence of an event and whether a patient met the 2014 or the 2017 criteria (OR: 1.39; 95% CI: 0.85-2.27; P = 0.18 or OR: 1.51; 95% CI: 0.97-2.33; P = 0.067, respectively). CONCLUSIONS: CS patients who met the 1993 and the 2006 criteria had higher odds of adverse clinical outcomes. Future research is needed to prospectively evaluate existing diagnostic schemes and develop new risk models for this complex disease.

QT-RR hysteresis is caused by differential autonomic states during exercise and recovery.

QT-RR hysteresis is characterized by longer QT intervals at a given RR interval while heart rates are increasing during exercise and shorter QT intervals at the same RR interval while heart rates are decreasing during recovery. It has been attributed to a lagging QT response to different directional changes in RR interval during exercise and recovery. Twenty control subjects (8 males, age 51 ± 6 yr), 16 subjects with type 2 diabetes (12 males, age 56 ± 8 yr), 71 subjects with coronary artery disease (CAD) and preserved left ventricular ejection fraction (LVEF) (≥50%) (51 males, age 59 ± 12 yr), and 17 CAD subjects with depressed LVEF (<50%) (13 males, age 57 ± 10 yr) underwent two 16-min exercise tests followed by recovery. In session 2, parasympathetic blockade with atropine (0.04 mg/kg) was achieved at end exercise. QT-RR hysteresis was quantified as: 1) the area bounded by the QT-RR relationships for exercise and recovery in the range of the minimum RR interval at peak exercise to the minimum RR interval + 100 ms and 2) the difference in QT interval duration between exercise and recovery at the minimum RR interval achieved during peak exercise plus 50 ms (ΔQT). The effect of parasympathetic blockade was assessed by substituting the QT-RR relationship after parasympathetic blockade. QT-RR hysteresis was positive in all groups at baseline and reversed by parasympathetic blockade (P < 0.01). We conclude that QT-RR hysteresis is not caused by different directional changes in RR interval during exercise and recovery. Instead, it is predominantly mediated by differential autonomic nervous system effects as the heart rate increases during exercise vs. as it decreases during recovery.

Prevalence and predictors of cable extrusion and loss of electrical integrity with the Riata defibrillator lead.

INTRODUCTION: Recently, a medical advisory was issued regarding the Riata and Riata ST silicone endocardial defibrillator leads (St. Jude Medical, Sylmar, CA, USA) addressing the issue of conductor cables extruding in an "inside-out" fashion from the main body of the lead. However, little data exist to guide our management of patients with these leads. METHODS AND RESULTS: A retrospective analysis was performed of 84 patients with a Riata lead who underwent cine-fluoroscopy and electrical evaluation as part of a screening program to assess for cable extrusion. All leads screened were dual-coil except for one single-coil lead. Of 84 patients, 23 patients (27.4%) had fluoroscopic evidence of cable extrusion. Multivariate analysis showed that the duration of time since lead implant and the presence of multiple right ventricular leads were significantly associated with cable extrusion. All 23 patients had normal electrical parameters on routine device interrogation. Fifteen of these 23 patients (65%) with extruded cables had high-voltage shocks within 12 months of lead screening; only one patient demonstrated postshock electrical abnormalities. CONCLUSIONS: The prevalence of cable extrusion in dual-coil Riata leads is significantly higher at 27.4% than previously reported. The duration of time since implantation and the presence of multiple right ventricular leads are associated with cable extrusion. High-energy shocks did not reveal electrical abnormalities in most patients with cable extrusion.

Exercise based assessment of cardiac autonomic function in type 1 versus type 2 diabetes mellitus.

BACKGROUND: Cardiac autonomic neuropathy (CAN) is a complication of diabetes mellitus (DM) that is associated with increased mortality. Exercise-based assessment of autonomic function has identified diminished parasympathetic reactivation after exercise in type 2 DM. It is postulated herein, that this would be more prominent among those with type 1 DM. METHODS: Sixteen subjects with type 1 DM (age 32.9 ± 10.1 years), 18 subjects with type 2 DM (55.4 ± 8.0 years) and 30 controls (44.0 ± 11.6 years) underwent exercise-based assessment of autonomic function. Two 16-min submaximal bicycle tests were performed followed by 45 min of recovery. On the second test, atropine (0.04 mg/kg) was administered near end-exercise so that all of the recovery occurred under parasympathetic blockade. Plasma epinephrine and norepinephrine levels were measured at rest, during exercise, and during recovery. RESULTS: There were no differences in resting or end-exercise heart rates in the three groups. Parasympathetic effect on RR-intervals during recovery (p < 0.03) and heart rate recovery (p = 0.02) were blunted in type 2 DM. Type 1 DM had higher baseline epinephrine and norepinephrine levels (p < 0.03), and exhibited persistent sympathoexcitation during recovery. CONCLUSIONS: Despite a longer duration of DM in the study patients with type 1 versus type 2 DM, diminished parasympathetic reactivation was not noted in type 1 DM. Instead, elevation in resting plasma catecholamines was noted compared to type 2 DM and controls. The variable pathophysiology for exercise-induced autonomic abnormalities in type 1 versus type 2 DM may impact prognosis.

Outcomes Associated With Catheter Ablation of Ventricular Tachycardia in Patients With Cardiac Sarcoidosis.

Importance: Ventricular tachycardia (VT) is associated with high mortality in patients with cardiac sarcoidosis (CS), and medical management of CS-associated VT is limited by high failure rates. The role of catheter ablation has been investigated in small, single-center studies. Objective: To investigate outcomes associated with VT ablation in patients with CS. Design, Setting, and Participants: This cohort study from the Cardiac Sarcoidosis Consortium registry (2003-2019) included 16 tertiary referral centers in the US, Europe, and Asia. A total of 158 consecutive patients with CS and VT were included (33% female; mean [SD] age, 52 [11] years; 53% with ejection fraction [EF] <50%). Exposures: Catheter ablation of CS-associated VT and, as appropriate, medical treatment. Main Outcomes and Measures: Immediate and short-term outcomes included procedural success, elimination of VT storm, and reduction in defibrillator shocks. The primary long-term outcome was the composite of VT recurrence, heart transplant (HT), or death. Results: Complete procedural success (no inducible VT postablation) was achieved in 85 patients (54%). Sixty-five patients (41%) had preablation VT storm that did not recur postablation in 53 (82%). Defibrillator shocks were significantly reduced from a median (IQR) of 2 (1-5) to 0 (0-0) in the 30 days before and after ablation (P < .001). During median (IQR) follow-up of 2.5 (1.1-4.9) years, 73 patients (46%) experienced VT recurrence and 81 (51%) experienced the composite primary outcome. One- and 2-year rates of survival free of VT recurrence, HT, or death were 60% and 52%, respectively. EF less than 50% and myocardial inflammation on preprocedural 18F-fluorodeoxyglucose positron emission tomography were significantly associated with adverse prognosis in multivariable analysis for the primary outcome (HR, 2.24; 95% CI, 1.37-3.64; P = .001 and HR, 2.93; 95% CI, 1.31-6.55; P = .009, respectively). History of hypertension was associated with a favorable long-term outcome (adjusted HR, 0.51; 95% CI, 0.28-0.92; P = .02). Conclusions and Relevance: In this observational study of selected patients with CS and VT, catheter ablation was associated with reductions in defibrillator shocks and recurrent VT storm. Preablation LV dysfunction and myocardial inflammation were associated with adverse long-term prognosis. These data support the role of catheter ablation in conjunction with medical therapy in the management of CS-associated VT.

Improvement in renal function following cryoballoon ablation for atrial fibrillation.

PURPOSE: Patients with chronic kidney disease are predisposed to heart rhythm disorders including atrial fibrillation (AF). Several studies have suggested that radiofrequency catheter ablation of AF improves renal function. However, little data exists for pulmonary vein isolation with cryoballoon ablation (CBA). The purpose of this study is to assess change in renal function following CBA for AF. METHOD: This is a single-center retrospective study that included patients who underwent CBA for AF between 2011 and 2016. Patients were grouped by baseline-estimated glomerular filtration rate (eGFR): ≥ 90 (Stage G1), 60-89.9 (Stage G2), and 30-59.9 mL/min/1.73 m2 (Stage G3). Change in eGFR was assessed > 3 months post-ablation. RESULTS: A total of 306 patients with both pre- and post-ablation serum creatinine measurements available were included. Baseline eGFRs for Stages G1, G2, and G3 patients were 103.5 ± 12.9 (n = 82), 74.7 ± 8.2 (n = 184), and 52.6 ± 6.6 mL/min/1.73 m2 (n = 40), respectively. Renal function was assessed 310.8 ± 104.2 days post-ablation. Average intra-procedural contrast use was 58.4 ± 23.8 mL. There was no significant change in eGFR following CBA in Stage G1 patients (p = 0.10). For those with Stages G2 and G3 renal function, eGFR improved by 6.1% (4.2 mL/min/1.73 m2, p < 0.01) and 13.8% (7.2 mL/min/1.73 m2, p < 0.01), respectively. This improvement was seen regardless of the presence or absence of recurrent atrial arrhythmias. CONCLUSIONS: CBA for AF may be associated with an improvement in renal function, particularly among those with a reduced baseline eGFR despite recurrence of atrial arrhythmias and intra-procedural contrast use.