Pulmonary vein narrowing after pulsed field versus thermal ablation.

AIMS: When it occurs, pulmonary vein (PV) stenosis after atrial fibrillation (AF) ablation is associated with significant morbidity. Even mild-to-moderate PV narrowing may have long-term implications. Unlike thermal ablation energies, such as radiofrequency (RF) or cryothermy, pulsed field ablation (PFA) is a non-thermal modality associated with less fibrotic proliferation. Herein, we compared the effects of PFA vs. thermal ablation on PV narrowing after AF ablation. METHODS AND RESULTS: ADVENT was a multi-centre, randomized, single-blind study comparing PFA (pentaspline catheter) with thermal ablation-force-sensing RF or cryoballoon (CB)-to treat drug-refractory paroxysmal AF. Pulmonary vein diameter and aggregate cross-sectional area were obtained by baseline and 3-month imaging. The pre-specified, formally tested, secondary safety endpoint compared a measure of PV narrowing between PFA vs. thermal groups, with superiority defined by posterior probability > 0.975. Among subjects randomized to PFA (n = 305) or thermal ablation (n = 302), 259 PFA and 255 thermal ablation (137 RF and 118 CB) subjects had complete baseline and 3-month PV imaging. No subject had significant (≥70%) PV stenosis. Change in aggregate PV cross-sectional area was less with PFA (-0.9%) than thermal ablation (-12%, posterior probability > 0.999)-primarily driven by the RF sub-cohort (-19.5%) vs. CB sub-cohort (-3.3%). Almost half of all PFA PV diameters did not decrease, but the majority (80%) of RF PVs decreased, regardless of PV anatomic location. CONCLUSION: In this first randomized comparison of PFA vs. thermal ablation, PFA resulted in less PV narrowing-thereby underscoring the qualitatively differential and favourable impact of PFA on PV tissue.

Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation.

BACKGROUND: Catheter-based pulmonary vein isolation is an effective treatment for paroxysmal atrial fibrillation. Pulsed field ablation, which delivers microsecond high-voltage electrical fields, may limit damage to tissues outside the myocardium. The efficacy and safety of pulsed field ablation as compared with conventional thermal ablation are not known. METHODS: In this randomized, single-blind, noninferiority trial, we assigned patients with drug-refractory paroxysmal atrial fibrillation in a 1:1 ratio to undergo pulsed field ablation or conventional radiofrequency or cryoballoon ablation. The primary efficacy end point was freedom from a composite of initial procedural failure, documented atrial tachyarrhythmia after a 3-month blanking period, antiarrhythmic drug use, cardioversion, or repeat ablation. The primary safety end point included acute and chronic device- and procedure-related serious adverse events. RESULTS: A total of 305 patients were assigned to undergo pulsed field ablation, and 302 were assigned to undergo thermal ablation. At 1 year, the primary efficacy end point was met (i.e., no events occurred) in 204 patients (estimated probability, 73.3%) who underwent pulsed field ablation and 194 patients (estimated probability, 71.3%) who underwent thermal ablation (between-group difference, 2.0 percentage points; 95% Bayesian credible interval, -5.2 to 9.2; posterior probability of noninferiority, >0.999). Primary safety end-point events occurred in 6 patients (estimated incidence, 2.1%) who underwent pulsed field ablation and 4 patients (estimated incidence, 1.5%) who underwent thermal ablation (between-group difference, 0.6 percentage points; 95% Bayesian credible interval, -1.5 to 2.8; posterior probability of noninferiority, >0.999). CONCLUSIONS: Among patients with paroxysmal atrial fibrillation receiving a catheter-based therapy, pulsed field ablation was noninferior to conventional thermal ablation with respect to freedom from a composite of initial procedural failure, documented atrial tachyarrhythmia after a 3-month blanking period, antiarrhythmic drug use, cardioversion, or repeat ablation and with respect to device- and procedure-related serious adverse events at 1 year. (Funded by Farapulse-Boston Scientific; ADVENT ClinicalTrials.gov number, NCT04612244.).

Catheter ablation of atrial fibrillation in patients with cor triatriatum sinister; case series and review of literature.

INTRODUCTION: Cor triatriatum sinister (CTS) is a rare congenital heart defect characterized by fibromuscular septation of the left atrium associated with atrial fibrillation (AF). The incidence of hemodynamically insignificant CTS in the AF ablation population and effect on ablation success are not known. Furthermore, little is known about the potential effect of CTS on arrhythmogenic substrate. OBJECTIVE: We define the incidence of hemodynamically insignificant CTS in patients undergoing AF ablation with RF and cryoballoon ablation, the technical challenges created by the left atrial partitioning, and the potentially arrhythmogenic effects of the membrane. We also review the literature of CA in patients with CTS. METHODS: First-time AF ablation cases at our institution over a 10-year period were screened to identify patients with CTS. Retrospective review was performed to obtain clinical characteristics and ablation data. RESULTS: Of the 3953 consecutive patients undergoing initial AF ablation during the study period, four patients (0.10%) had CTS. Ablation was successful acutely in all patients. One patient had recurrent AF and required repeat ablation for a single procedure success rate of 75% and multi-procedure success rate of 100%. The CTS membrane was associated with low voltage zones in the two patients in whom it was measured and with substrate for macro-reentrant atrial tachycardia in one of these patients. CONCLUSION: The incidence of hemodynamically insignificant CTS in patients undergoing CA for AF is very low, but does not serve as a significant barrier to successful ablation as long as directed access to the superoposterior chamber is obtained.

Renal Sympathetic Denervation as Upstream Therapy During Atrial Fibrillation Ablation: Pilot HFIB Studies and Meta-Analysis.

OBJECTIVES: This study sought to determine the impact of adjunctive renal sympathetic denervation to catheter ablation in patients with atrial fibrillation (AF) and history of hypertension. BACKGROUND: There are limited data regarding the impact of upstream adjunctive renal sympathetic denervation (RSDN) to pulmonary vein isolation (PVI) in patients with symptomatic atrial fibrillation (AF) and hypertension. METHODS: The data for this study were obtained from 2 prospective randomized pilot studies, the HFIB (Adjunctive Renal Denervation to Modify Hypertension and Sympathetic tone as Upstream Therapy in the Treatment of Atrial Fibrillation)-1 (n = 30) and HFIB (Adjunctive Renal Denervation to Modify Hypertension and Sympathetic tone as Upstream Therapy in the Treatment of Atrial Fibrillation)-2 (n = 50) studies, and we performed a meta-analysis including all published studies comparing RSDN+PVI versus PVI alone up to January 25, 2020, in patients with AF and hypertension. RESULTS: At 24 months, AF recurrence occurred in 53% and 38% in the PVI and PVI+RSDN groups (p = 0.43) in the HFIB-1 study, respectively, and 27% and 25% in the PVI and PVI+RSDN groups (p = 0.80) in the HFIB-2 study, respectively. When combined in a meta-analysis including 6 studies (n = 725), adjunctive RSDN significantly decreased the risk of AF recurrence (risk ratio [RR]: 0.68; 95% confidence interval [CI]: 0.55 to 0.83; p = 0.0002; I2 = 0%) when compared with PVI. Six renal artery complications occurred in the HFIB-1 study and none occurred in the HFIB-2 study with RSDN. However, in the meta-analysis, there were no significant differences in overall complications between both groups (RR: 1.43; 95% CI: 0.63 to 3.22; p = 0.40; I2 = 7%). When compared with baseline, RDSN significantly reduced the systolic blood pressure (-12.1 mm Hg; 95% CI: -20.9 to -3.3 mm Hg; p < 0.007; I2 = 99%) and diastolic blood pressure (-5.60 mm Hg; 95% CI: -10.05 to -1.10 mm Hg; p = 0.01; I2 = 98%) on follow-up. CONCLUSIONS: The pilot HFIB-1 and HFIB-2 studies did not demonstrate a benefit with RSDN as an adjunctive upstream therapy during PVI. However, in the meta-analysis, adjunctive RSDN to PVI appears to be safe, and improves clinical outcomes in AF patients with a history of hypertension.

A Novel Temperature-Controlled Radiofrequency Catheter Ablation System Used to Treat Patients With Paroxysmal Atrial Fibrillation.

OBJECTIVES: DIAMOND-AF (DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation) was a prospective, multicenter, noninferiority, randomized trial that compared the safety and effectiveness of the DTA system versus those of a force-sensing RF ablation system (control) for the treatment of patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (AF). BACKGROUND: Irrigated radiofrequency (RF) ablation catheters lose tissue temperature acuity, which is vital in assessing lesion formation. DiamondTemp Ablation (DTA) was designed to re-establish accurate tissue temperature measurements during ablation. METHODS: A total of 482 patients with paroxysmal AF were randomized (239 DTA, 243 control) to undergo pulmonary vein isolation and were followed up at 23 sites. Patients were screened for disease progression, cardiac characteristics, and prior interventions. Primary endpoints were effectiveness (freedom from atrial arrhythmia recurrence) and safety (composite of procedure- and device-related serious adverse events). RESULTS: The primary safety event rate was 3.3% in the DTA group versus 6.6% in the control group (p < 0.001 vs. 6.5% noninferiority margin). Primary effectiveness was met in 79.1% of DTA subjects and 75.7% of control subjects (p < 0.001 vs. -12.5% noninferiority margin). Secondary endpoint analysis found that off-drug effectiveness favored DTA compared with the control (142 [59.4%] vs. 120 [49.4%], respectively; p = 0.03). Total RF time and individual RF ablation duration were significantly shorter with less saline infused through the DTA catheter (p < 0.001). Both arms saw clinically meaningful improvements in quality of life at 12 months. CONCLUSIONS: Safety and efficacy of the DTA system proved noninferior to force-sensing RF ablation in a paroxysmal AF population. Efficiencies were observed using DTA with shorter total RF times, individual RF ablation durations, and less saline infusion. (DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation; NCT03334630).

Short-term safety and efficacy of left atrial appendage closure with the WATCHMAN device in patients with small left atrial appendage ostia.

INTRODUCTION: Left atrial appendage (LAA) closure with the WATCHMAN device, according to FDA labelling, is recommended in patients with a maximal LAA ostial width between 17 and 31 mm. The safety and efficacy of LAA closure in patients with a maximal LAA ostial width < 17 mm has not been evaluated. The goal of this study was to determine the acute and short-term safety and efficacy of LAA closure with the WATCHMAN device in patients with a maximal LAA ostial width < 17 mm. METHODS AND RESULTS: Thirty-two consecutive patients with a maximal LAA ostial width < 17 mm as determined by a screening transesophageal echocardiogram (TEE) underwent LAA closure with the WATCHMAN device between March 2015 and November 2016 at five medical centers, and were included in this study. Mean age, body mass index (BMI), and CHA2 DS2 -VASC score were 70.8 ± 8.6 years, 29.3 ± 6.5 kg/m2 , and 3.9 ±1.2, respectively. At the screening TEE, mean maximal LAA ostial width and depth were 15.6 ± 0.6 mm (range 14-16) and 23.2 ± 4.5 mm (range 13-31), respectively. Successful LAA closure with the WATCHMAN device was achieved in 31 of 32 patients (97%), with no major complications. TEE performed 45 days after LAA closure demonstrated no peridevice leak > 5 mm and no device related thrombi. Warfarin was discontinued in all 31 patients 45 days after LAA closure. CONCLUSIONS: LAA closure with the WATCHMAN device can be successfully and safely achieved in patients with a maximal LAA ostial width < 17 mm.

The Effect of Chronic Kidney Disease on Mortality with Cardiac Resynchronization Therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) improves functional status, reduces heart failure hospitalizations, and decreases mortality. Several comorbidities including renal function affect outcomes with CRT. However, moderate to severe chronic kidney disease (CKD) was an exclusion criterion in the large randomized control trials. OBJECTIVE: To evaluate the association of renal function on survival following CRT implantation. METHODS: This was a retrospective analysis of 432 consecutive patients implanted with an implantable cardioverter defibrillator with CRT (CRT-D). The primary end point was defined as death by any cause, and it was determined using hospital records and the U.S. Social Security Death Index. A Kaplan-Meier analysis was performed separating renal dysfunction into renal stage based on glomerular filtration rate. Multivariate analysis was performed to assess the clinical predictors of mortality. RESULTS: Patients were followed for up to 12 years with a mean follow-up time of 4.3 ± 3.2 years. A total of 164 patients (39.3%) died over the course of the study. Patients with normal and mild renal diseases (Stages 1 and 2) had improved survival compared with those with moderate-, severe-, or end-stage (Stages 3-5) renal disease. This effect remained statistically significant after multivariate analysis. The estimated 5-year mortality was 36.3% for stage 1, 33.4% for stage 2, 40.6% for stage 3, and 62.1% for stage 4/5 kidney disease (P = 0.004 by log-rank test). CONCLUSION: CKD is a strong and an independent predictor of long-term mortality among patients undergoing CRT-D implantation.

Short and long-term outcomes of percutaneous left atrial appendage suture ligation: Results from a US multicenter evaluation.

BACKGROUND: Published studies of epicardial ligation of left atrial appendage (LAA) have reported discordant results. OBJECTIVE: The purpose of this study was to delineate the safety and efficacy of LAA closure with the LARIAT device. METHODS: This is a multicenter registry of 712 consecutive patients undergoing LAA ligation with LARIAT at 18 US hospitals. The primary end point was successful suture deployment, no leak by intraprocedural transesophageal echocardiography (TEE), and no major complication (death, stroke, cardiac perforation, and bleeding requiring transfusion) at discharge. A leak of 2-5 mm on follow-up TEE was the secondary end point. RESULTS: LARIAT was successfully deployed in 682 patients (95.5%). A complete closure was achieved in 669 patients (98%), while 13 patients (1.8%) had a trace leak (<2 mm). There was 1 death related to the procedure. Ten patients (1.44%) had cardiac perforation necessitating open heart surgery, while another 14 (2.01%) did not need surgery. The risk of cardiac perforation decreased significantly after the introduction of a micropuncture (MP) needle for pericardial access. Delayed complications (pericarditis requiring >2 weeks of treatment with nonsteroidal anti-inflammatory drugs/colchicine and pericardial and pleural effusion after discharge) occurred in 34 (4.78%) patients, and the risk decreased significantly with the periprocedural use of colchicine. Follow-up TEE (n = 480) showed a leak of 2-5 mm in 6.5% and a thrombus in 2.5%. One patient had a leak of >5 mm. CONCLUSION: LARIAT effectively closes the LAA and has acceptable procedural risks with the evolution of the use of the micropuncture needle for pericardial access and the use of colchicine for mitigating the postinflammatory response associated with LAA ligation and pericardial access.

Pulmonary Vein Isolation Using the Visually Guided Laser Balloon: A Prospective, Multicenter, and Randomized Comparison to Standard Radiofrequency Ablation.

BACKGROUND: Balloon catheters have been designed to facilitate pulmonary vein (PV) isolation in patients with paroxysmal atrial fibrillation (AF). The visually guided laser balloon (VGLB) employs laser energy to ablate tissue under direct visual guidance. OBJECTIVES: This study compared the efficacy and safety of VGLB ablation with standard irrigated radiofrequency ablation (RFA) during catheter ablation of AF. METHODS: Patients with drug-refractory paroxysmal AF were enrolled in a multicenter, randomized controlled study of PV isolation using either the VGLB or RFA (control). The primary efficacy endpoint was freedom from protocol-defined treatment failure at 12 months, including symptomatic AF occurring after the 90-day blanking period. The primary efficacy and safety endpoints were powered for noninferiority. RESULTS: A total of 353 patients (178 VGLB, 175 control) were randomized at 19 clinical sites. The mean procedure, ablation, and fluoroscopy times were longer with VGLB compared with controls. The primary efficacy endpoint was met in 61.1% in the VGLB group versus 61.7% in controls (absolute difference -0.6%; lower limit of 95% confidence interval [CI]: -9.3%; p = 0.003 for noninferiority). The primary adverse event rate was 11.8% in the VGLB group versus 14.5% in controls (absolute difference -2.8%; upper limit of 95% CI: 3.5; p = 0.002 for noninferiority), and was mainly driven by cardioversions. Diaphragmatic paralysis was higher (3.5% vs. 0.6%; p = 0.05), but PV stenosis was lower (0.0% vs. 2.9%; p = 0.03) with VGLB. CONCLUSIONS: Despite minimal prior experience, the safety and efficacy of VGLB ablation proved noninferior to RFA for the treatment of paroxysmal AF. (Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System-Adaptive Contact [EAS-AC] [HeartLight] in Patients With Paroxysmal Atrial Fibrillation [PAF] [HeartLight]; NCT01456000).

Safety of continuous anticoagulation with dabigatran during implantation of cardiac rhythm devices.

The perioperative bleeding risk associated with therapeutic anticoagulation at cardiac implantable electronic device implantation has previously been demonstrated to vary by the specific anticoagulant used. Although uninterrupted anticoagulation with warfarin appears to be safe, heparin products have been shown to increase the risk of perioperative bleeding. However, the risk associated with cardiac implantable electronic device implantation with anticoagulation using dabigatran, a novel oral direct thrombin inhibitor, is not known. We performed a prospective observational study of patients receiving dabigatran for anticoagulation who underwent cardiac implantable electronic device implantation from June 2011 through May 2012. The study end points included thromboembolic and bleeding complications within 30 days of surgery. Major bleeding complications were defined as bleeding requiring surgical intervention, prolongation of hospitalization, and discontinuation of the anticoagulant or transfusion of blood products within 30 days of surgery. Minor bleeding complications included the development of a hematoma not requiring additional intervention. The thrombotic end points included stroke, transient ischemic attack, myocardial infarction, pulmonary embolism, and deep vein thrombosis. A total of 25 patients were identified for inclusion. During the index hospitalization, no thromboembolic or bleeding complications developed. No major bleeding complications occurred within 30 days of surgery. One minor bleeding event (4%) occurred within 30 days of surgery in 1 patient who was also receiving dual antiplatelet therapy. In conclusion, although no thromboembolic or major bleeding events were observed, additional studies are required to define the optimal antithrombotic management in the perioperative period.

Comparison of fixed tilt and tuned defibrillation waveforms: the PROMISE study.

BACKGROUND: All modern defibrillation systems use biphasic shock waveforms. Typically a fixed tilt waveform is used for implantable defibrillators (ICDs), but a tuned waveform with duration based on shock impedance may be superior based on theoretical calculations. OBJECTIVE: The objective of this study was to compare defibrillation efficacy of fixed tilt and tuned waveforms. METHODS: PROMISE was designed as a prospective, within-patient, randomized study of defibrillation thresholds (DFTs) comparing a tuned (assuming a 3.5 milliseconds membrane time constant) versus a 50/50% tilt waveform. All patients had a left pectoral implant (active can) and testing was performed with a single coil shocking configuration ("SVC coil OFF"). DFTs were measured in random order with a binary search method in 52 patients, using the high-voltage lead impedance to select the pulse widths for both waveforms. RESULTS: At the DFT, the tuned waveform had similar delivered energy (10.5 ± 6.3 vs 9.5 ± 5.5 J, P = 0.47), stored energy (13.6 ± 7.9 vs 11.3 ± 6.3 J, P = 0.06), peak current (7.5 ± 3.0 vs 6.8 ± 2.2 A, P = 0.09), and delivered voltage (451.0 ± 134.5 vs 411.5 ± 120.7 V, P = 0.05) compared with the 50/50% tilt waveform. CONCLUSION: The DFTs for 3.5-millisecond time constant based tuned and 50/50% tilt waveforms are similar using a single coil, left pectoral active can.

Optimization of cardiac resynchronization therapy: importance of programmed parameters.

One of the basic tenets of cardiac resynchronization therapy (CRT) is that optimization of programmed parameters is important to maximize the therapeutic response. Both atrioventricular (AV) and interventricular (VV) timing intervals have been suggested as potential methods to improve response rates. A variety of techniques have been described to determine the optimal AV and VV delays. Many of these methods have demonstrated acute hemodynamic benefits; however, multicenter data proving long-term clinical benefit have been lacking. Echocardiography-guided methods have been most commonly employed, but no technique has been shown to be superior. In fact, many of these techniques have poor reproducibility and are time-consuming. Device-based algorithms allow for a rapid, simplified approach to CRT optimization; however, their clinical value has also been called into question. This review will describe the different techniques for CRT optimization and evaluate their potential value and limitations.

Defibrillation Threshold Testing: Who Doesn't Get It?

Defibrillation testing has been routinely performed as part of the implantable cardioverter-defibrillator (ICD) implantation procedure, and is currently supported by practice guidelines; however, more recently, this practice has been called into question. Such testing is safe, and serious complications are rare. With modern ICD systems, physicians will rarely encounter a patient in whom defibrillation will fail. This article reviews the literature regarding the utility, necessity, complications, and cost of routine operative and follow-up defibrillation testing, and, it is hoped, clarifies the issue of "Who doesn't get it?"

Defibrillation thresholds in hypertrophic cardiomyopathy.

BACKGROUND: Defibrillation threshold (DFT) testing is performed in part to ensure an adequate safety margin for the termination of spontaneous ventricular arrhythmias. Left ventricular mass is a predictor of high DFTs, so patients with hypertrophic cardiomyopathy (HCM) are often considered to be at risk for increased defibrillation energy requirements. However, there are little prospective data addressing this issue. OBJECTIVE: To assess DFTs in patients with HCM and evaluate the clinical predictors of elevated DFTs. METHODS: Eighty-nine consecutive patients with HCM and 600 control patients with ischemic or nonischemic cardiomyopathy underwent a uniform modified step-down DFT testing protocol. DFT was compared between the control and HCM populations. Predictors of elevated DFT were evaluated in the HCM group. RESULTS: There was no difference in DFT between HCM and control groups (10.4 ± 5.8 J vs 11.2 ± 5.6 J, respectively). Among patients with HCM, clinical parameters such as left ventricular ejection fraction, interventricular septal thickness, left ventricular mass, and QRS duration were not predictive of an elevated DFT. Only 3 patients (3.4%) with HCM had a DFT >20 J. CONCLUSION: Patients with HCM do not have elevated DFTs as compared to more typical populations undergoing implantable cardioverter-defibrillator implant; high-energy devices or complex lead systems are not needed routinely in this population.

Randomized comparison of defibrillation thresholds from the right ventricular apex and outflow tract.

BACKGROUND: Implantable cardioverter-defibrillator (ICD) leads are traditionally placed in the right ventricular apex (RVA), in part because this is considered the preferred vector for minimizing defibrillation threshold (DFT). However, if adequate DFT safety margins are attainable, ICD leads placed in the right ventricular outflow tract (RVOT) might confer advantages if frequent ventricular pacing is anticipated. OBJECTIVE: The purpose of this study was to compare RVA with RVOT transvenous ICD lead position on DFT. METHODS: This was a prospective, randomized, crossover study of RVA versus RVOT DFT in 33 patients undergoing left pectoral ICD placement. A binary search algorithm was used to measure DFT, with initial lead position tested in randomized order. The relationship between RVOT position and DFT was assessed by evaluation of the distance between RVA and RVOT. RESULTS: The study population had a mean age of 59 ± 12 years and ejection fraction of 33% ± 14%. Mean DFT in the RVA was 9.8 ± 7.3 J versus 10.8 ± 7.2 J in the RVOT (P = .53), with no correlation between RVOT location and DFT. CONCLUSION: The study found no evidence that ICD lead placement in the RVOT is associated with significantly higher DFT than lead placement in the RVA.

Implantable cardioverter-defibrillator therapy for primary prevention of sudden death after alcohol septal ablation of hypertrophic cardiomyopathy.

OBJECTIVES: The purpose of this study was to examine the effects of alcohol septal ablation (ASA) on ventricular arrhythmias among patients with obstructive hypertrophic cardiomyopathy (HCM), as measured by appropriate implantable cardioverter-defibrillator (ICD) discharges. BACKGROUND: Alcohol septal ablation is an effective therapy for patients with symptomatic HCM. However, concern has been raised that ASA may be proarrhythmic secondary to the iatrogenic scar created during the procedure. The impact of ASA on ventricular arrhythmias has not been well described. METHODS: This prospective study included 123 consecutive patients with obstructive HCM who underwent ASA and had an ICD implanted for primary prevention of sudden cardiac death (SCD). The ICDs were implanted based on commonly accepted risk factors for SCD in the HCM population. Data from ICD interrogations during routine follow-up were collected. RESULTS: Nine appropriate ICD shocks were recorded over a mean follow-up of 2.9 years in the cohort, which had a mean of 1.5 +/- 0.9 risk factors for SCD. Using Kaplan-Meier survival analysis, the estimated annual event rate was 2.8% over 3-year follow-up. There were no significant differences in the incidence of risk factors between patients who did and did not receive appropriate shocks. CONCLUSIONS: The annual rate of appropriate ICD discharges after ASA is low and less than that reported previously for primary prevention of SCD in HCM. This suggests that ASA is not proarrhythmic. Traditional SCD risk factors did not predict ICD shocks in this cohort.

Effect of obesity on flap and donor-site complications in pedicled TRAM flap breast reconstruction.

BACKGROUND: The detrimental effects of obesity on pedicled and free transverse rectus abdominis myocutaneous (TRAM) flap reconstructions, including flap loss, hematoma, and donor-site hernia, are well documented. This study examined the effect of obesity on complications in patients undergoing pedicled TRAM flap breast reconstruction. METHODS: A retrospective review of 224 pedicled TRAM flaps in 200 patients over a 10-year period was carried out. Patients were divided into three groups: normal weight (body mass index < 25; 47 percent of patients), overweight (body mass index 25 to 29.9; 38 percent), and obese (body mass index > or = 30; 15 percent). There were no statistically significant differences in age, smoking history, radiation/chemotherapy history, distribution of flap pedicle types, timing of reconstruction, percentage of delay procedures performed, or expanders implanted among the three subgroups. Donor-site, flap, and other miscellaneous complications were compared among subgroups, and logistic regression analysis was used to identify risk factors for flap and donor-site complications. RESULTS: Compared with normal weight and overweight patients, obese patients had a statistically significantly higher incidence of multiple flap complications (36.7 percent versus 10.6 percent and 36.7 percent versus 10.5 percent, respectively; p = 0.0036) and partial flap necrosis (21.6 percent versus 5.8 percent and 21.6 percent versus 7.1 percent; p = 0.01 and p = 0.03, respectively). Lastly, obese patients had a significantly higher incidence of overall (one or more) donor-site complications when compared with normal weight patients (53.3 percent versus 31.9 percent; p = 0.0499). CONCLUSION: Obese patients, in contrast to normal weight and overweight patients, have a statistically significantly higher risk for developing overall (one or more) and multiple flap complications, overall donor-site complications, TRAM flap delayed wound healing, and minor flap necrosis.

Characterization of the coronary sinus ostium by cardiac magnetic resonance imaging.

The diameter and the angle of the coronary sinus (CS) ostium was analyzed in 101 patients who underwent cardiac magnetic resonance imaging and had left ventricular ejection fractions < or =0.35 (n = 40) or > or =0.65 (n = 61). The angle of the CS ostium in patients with LVEFs < or =0.35 was less acute than in patients with LVEFs > or =0.65 (73 degrees +/- 12 degrees vs 65 degrees +/- 10 degrees, p <0.01). There was no statistically significant difference in the diameter of the CS ostium in patients with LVEFs < or =0.35 compared with those with LVEFs > or =0.65 (8 +/- 3 vs 8 +/- 2 mm, p = 0.5). The diameter and the angle of the CS ostium were not different when analyzed on the basis of the duration of the QRS complex, left atrial dimension, or left ventricular end-diastolic dimension. In conclusion, on the basis of cardiac magnetic resonance imaging data, the angle of the CS is less acute in patients with LVEFs < or =0.35 than in those with LVEFs > or =0.65.

The effect of smoking on flap and donor-site complications in pedicled TRAM breast reconstruction.

BACKGROUND: The detrimental effects of smoking on pedicled and free flap reconstruction are well documented. The purpose of this study was to examine the effect of smoking on flap, donor-site, and other individual and multiple complications in pedicled transverse rectus abdominis myocutaneous (TRAM) flap breast reconstruction. METHODS: A retrospective review was carried out of 224 pedicled TRAM flaps in 200 patients over a 10-year period. Three subgroups of patients were identified: active smokers, former smokers (defined as patients who stopped smoking at least 4 weeks before reconstruction), and nonsmokers (patients with no history of smoking). Active smokers made up 15.5 percent of the study population, while former smokers and nonsmokers made up 17.5 percent and 67 percent, respectively. There were no statistically significant differences in age, weight, radiation/chemotherapy history, distribution of flap pedicle types, timing of reconstruction, or percentage of delay procedures performed among the smoking subgroups. Logistic regression analysis was used to identify significant risk factors and determine their odds ratios. RESULTS: Compared with nonsmokers, both active and former smokers had a higher incidence of multiple flap complications (p = 0.0023 and 0.0018, respectively; odds ratios, 5.1 and 4.9). Active smokers also had a statistically significant higher rate of TRAM infection compared with nonsmokers (p = 0.0243; odds ratio, 4.7). Finally, former smokers were found to have a higher rate of TRAM delayed wound healing compared with nonsmokers (p = 0.0165; odds ratio, 4.7). CONCLUSIONS: Logistic regression identified active smoking as a statistically significant risk factor for developing multiple flap complications and TRAM infection, while former smoking was a risk factor for multiple flap complications and TRAM delayed wound healing. Thus, active and former smoking should similarly be considered contraindications for pedicled TRAM flap breast reconstruction, unless the patient has stopped smoking for more than 4 weeks before surgery.

Safety and risk factors for breast reconstruction with pedicled transverse rectus abdominis musculocutaneous flaps: a 10-year analysis.

BACKGROUND: The purpose of this study is to examine the effect of various risk factors on complications in patients undergoing pedicled transverse rectus abdominis musculocutaneous (TRAM) flap breast reconstruction. METHODS: A retrospective review of 224 pedicled TRAMs in 200 patients over a 10-year period was carried out. Patients were divided into subgroups based on smoking history, weight, radiation status, and pedicle type. Complication rates were calculated and logistic regression analysis was used to identify risk factors. RESULTS: Logistic regression identified active smoking as a statistically significant risk factor for developing multiple (2 or more) flap complications (P = 0.0061) and TRAM infection (P = 0.0255), while former smoking was a risk factor for multiple flap complications (P = 0.01) and TRAM-delayed wound healing (P = 0.0433). Obesity (body mass index > or =30) was found to be a statistically significant risk factor for overall (1 or more) donor-site complications (P = 0.0281), overall flap complications (P = 0.0375), multiple flap complications (P = 0.0002), TRAM-delayed wound healing (P = 0.0334), and minor flap necrosis (P = 0.0075). CONCLUSIONS: This study identified that active or former smoking and obesity contribute to a significant complication rate, while overweight body habitus, use of double-pedicled flaps, and pre-TRAM radiation do not. This second decade "look-back" on pedicled TRAM flap breast reconstruction emphasizes the need for appropriate patient selection to achieve successful results with pedicled TRAM breast reconstruction.