A Modular Communicative Leadless Pacing-Defibrillator System.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) is associated with fewer lead-related complications than a transvenous ICD; however, the subcutaneous ICD cannot provide bradycardia and antitachycardia pacing. Whether a modular pacing-defibrillator system comprising a leadless pacemaker in wireless communication with a subcutaneous ICD to provide antitachycardia and bradycardia pacing is safe remains unknown. METHODS: We conducted a multinational, single-group study that enrolled patients at risk for sudden death from ventricular arrhythmias and followed them for 6 months after implantation of a modular pacemaker-defibrillator system. The safety end point was freedom from leadless pacemaker-related major complications, evaluated against a performance goal of 86%. The two primary performance end points were successful communication between the pacemaker and the ICD (performance goal, 88%) and a pacing threshold of up to 2.0 V at a 0.4-msec pulse width (performance goal, 80%). RESULTS: We enrolled 293 patients, 162 of whom were in the 6-month end-point cohort and 151 of whom completed the 6-month follow-up period. The mean age of the patients was 60 years, 16.7% were women, and the mean (±SD) left ventricular ejection fraction was 33.1±12.6%. The percentage of patients who were free from leadless pacemaker-related major complications was 97.5%, which exceeded the prespecified performance goal. Wireless-device communication was successful in 98.8% of communication tests, which exceeded the prespecified goal. Of 151 patients, 147 (97.4%) had pacing thresholds of 2.0 V or less, which exceeded the prespecified goal. The percentage of episodes of arrhythmia that were successfully terminated by antitachycardia pacing was 61.3%, and there were no episodes for which antitachycardia pacing was not delivered owing to communication failure. Of 162 patients, 8 died (4.9%); none of the deaths were deemed to be related to arrhythmias or the implantation procedure. CONCLUSIONS: The leadless pacemaker in wireless communication with a subcutaneous ICD exceeded performance goals for freedom from major complications related to the leadless pacemaker, for communication between the leadless pacemaker and subcutaneous ICD, and for the percentage of patients with a pacing threshold up to 2.0 V at a 0.4-msec pulse width at 6 months. (Funded by Boston Scientific; MODULAR ATP ClinicalTrials.gov NCT04798768.).

Ventricular Tachyarrhythmias in Patients With Hypertrophic Cardiomyopathy and Defibrillators: Triggers, Treatment, and Implications.

INTRODUCTION: Triggers and ICD interventions of ventricular arrhythmias in patients with hypertrophic cardiomyopathy (HCM) offer insight into mechanisms and treatment. METHODS AND RESULTS: Intracardiac ICD electrograms from 71 HCM patients in the HCM I and II studies were analyzed by three individuals. Rhythms were defined as VF (polymorphic ventricular arrhythmia), VT (monomorphic ventricular tachycardia), and ventricular flutter (VFL; VT ≥ 240 bpm). Physical activity and rhythm preceding the arrhythmia were ascertained. Of 149 arrhythmias, VF was present in 74, VT in 57, and VFL in 18. In those whose activity was known, moderate or intense physical activity was associated with over 50% of the tachycardias (57 of 111). Rhythms preceding ventricular arrhythmias were often sinus tachycardia (49 of 149; 33%) or rapid atrial fibrillation (7 of 149; 5%). VF and VFL were more likely preceded by supraventricular rhythms >100 bpm (30 of 68 with VF; 44%; 12 of 16 with VFL 75%, vs. 14 of 50 with VT 28%; P = 0.001). Antitachycardia pacing (ATP) was successful in 39 of 53 (74%). Multiple shocks were more often required to terminate VFL (10 of 18; 56%) compared to VF (10 of 72; 14%) and VT (2 of 25; 8%; P < 0.0001). Of arrhythmias requiring more than one shock to terminate, 16 of 22 were preceded by sinus tachycardia and/or moderate or extreme physical activity. CONCLUSIONS: Rapid supraventricular rhythms, and at least moderate activity, frequently precede VT and VF, and when they occur in these situations often require multiple ICD shocks to restore sinus rhythm. ATP is successful in terminating VT and VFL, and should be a programmed in all HCM patients with ICDs.

Development of a Chest Wall Protector Effective in Preventing Sudden Cardiac Death by Chest Wall Impact (Commotio Cordis).

OBJECTIVE: Commotio cordis, sudden death with chest impact, occurs clinically despite chest wall protectors worn in sports. In an experimental model of commotio cordis, commercially available chest wall protectors failed to prevent ventricular fibrillation (VF). The goal of the current investigation was to develop a chest wall protector effective in the prevention of commotio cordis. DESIGN: In the Tufts experimental model of commotio cordis the ability of chest protectors to prevent VF was assessed. Impacts were delivered with a 40-mph lacrosse ball, timed to the vulnerable period for VF. INTERVENTION: A chest wall protector or no chest wall protector (control) was randomly assigned to be placed over the chest. Four iterative series of 2 to 4 different chest wall material combinations were assessed. Materials included 3 different foams (Accelleron [Unequal Technologies, Glen Mills, PA], closed cell high density foam; Airilon [Unequal Technologies, Glen Mills, PA], closed cell low density soft foam; and an open cell memory foam) that were adhered to a layer of TriDur (Unequal Technologies, Glen Mills, PA), a flexible elastomeric coated aramid that was bonded to a semirigid polypropylene polymer (ImpacShield, Unequal Technologies, Glen Mills, PA). MAIN OUTCOME MEASURE: Induction of VF by chest wall impact was the primary outcome. RESULTS: Of 80 impacts without chest protectors, 43 (54%) resulted in VF. Ventricular fibrillation with chest protectors ranged from a high of 60% to a low of 5%. Of 12 chest protectors assessed, only 3 significantly lowered the risk of VF compared with impacts without chest protectors. These 3 chest protectors were combinations of Accelleron, Airilon, TriDur, and ImpacShield of different thicknesses. Protection increased linearly with the thicker combinations. CONCLUSIONS: Effective protection against VF with chest wall protection can be achieved in an experimental model of commotio cordis. CLINICAL RELEVANCE: Chest protector designs incorporating these novel materials will likely be effective in the prevention of commotio cordis on the playing field.

Single Coil Implantable Cardioverter Defibrillator Leads in Patients With Hypertrophic Cardiomyopathy.

Patients with hypertrophic cardiomyopathy (HC) may require higher energies to terminate ventricular fibrillation (VF); thus, dual coil defibrillation leads are often implanted. However, single coil leads may be preferred in young patients. All patients with HCM implanted with a transvenous ICD from years 2000 to 2014 were included. Of 249 patients, 223 underwent VF testing including 150 with a dual coil lead and 73 a single coil. Patients tested with dual coil compared with single coil had lower successful VF energies (15.7 ± 6.1 joule to 20.2 ± 7.9 joule (p <0.0001)). Adequate safety margin for defibrillation was noted in 97.3% of patients. Notably, 6 (4 with single coil leads) had inadequate safety margins (defined as ≥10 joule). Three of these 6 patients required replacement of a single coil lead with a dual coil lead. The remaining 3 underwent waveform tilt alteration, higher energy ICD, or removal of the can from the shock vector. There were no clinical or implant predictors of inadequate safety margins. In follow-up of 16 ± 30 months (range 0 to 170), there were 24 arrhythmias including 13 VF, all successfully terminated. In conclusion, in HC patients undergoing ICD implantation, single coil leads can provide adequate safety margins. In conclusion, defibrillation testing should be considered in all HC patients undergoing ICD implantation, and should be performed in those undergoing implantation with a single coil lead.

Serious Cardiovascular Adverse Events Reported with Intravenous Sedatives: A Retrospective Analysis of the MedWatch Adverse Event Reporting System.

BACKGROUND: Serious cardiovascular adverse events (SCAEs) associated with intravenous sedatives remain poorly characterized. OBJECTIVE: The objective of this study was to compare SCAE incidence, types, and mortality between intravenous benzodiazepines (i.e., diazepam, lorazepam, and midazolam), dexmedetomidine, and propofol in the USA over 8 years regardless of the clinical setting where it was administered. METHODS: The Food and Drug Administration's MedWatch Adverse Event Reporting System was searched between 2004 and 2011 using the Evidex® platform from Advera Health Analytics, Inc. to identify all reports that included one or more of ten different SCAEs (package insert incidence ≥ 1%) and where an intravenous benzodiazepine, dexmedetomidine, or propofol was the primary suspected drug. RESULTS: Among the 2326 Food and Drug Administration's MedWatch Adverse Event Reporting System cases reported, 394 (16.9%) were related to a SCAE. The presence of a SCAE (vs. a non-SCAE) is associated with higher mortality (34 vs. 8%, p < 0.001). The percentage of cases with one or more SCAE, the case mortality rate (%), and the incidence of each SCAE (per 106 days of sedative exposure), respectively, were benzodiazepines (14, 26, 13) [diazepam (13, 23, 31); lorazepam (15, 43, 14); midazolam (14, 20, 11)]; dexmedetomidine (40, 15, 13); and propofol (17, 39, 7). Propofol (vs. either a benzodiazepine or dexmedetomidine) was associated with more total SCAEs (268 vs. 126, p < 0.001) but a lower incidence (per 106 days of sedative exposure) of SCAE (7 vs. 13, p = 0.0001) and cardiac arrest [6.3 (benzodiazepine) vs. 6.7 (dexmedetomidine) vs. 1.4 (propofol), p < 0.0001]. CONCLUSIONS: Serious cardiac adverse events account for nearly one-fifth of intravenous sedative Food and Drug Administration's MedWatch Adverse Event Reporting System reports. These SCAEs appear to be associated with greater mortality than non-cardiac serious adverse events. Serious cardiac events may be more prevalent with either benzodiazepines or dexmedetomidine than propofol.

Advances in mechanisms of atrial fibrillation: structural remodeling, high-frequency fractionated electrograms, and reentrant AF drivers.

The mechanisms to explain atrial fibrillation (AF) have been widely debated. Although contemporary experimental techniques have provided more insight, hypotheses regarding AF propagation conceived in the early half of the century remain minimally altered and relevant today. Modern mapping technologies have implicated multiwavelet reentry as the electrophysiologic basis to explain AF propagation within the atrial myocardium; however, reentry has also been observed within pulmonary veins and may behave as a focal trigger. The ability to terminate AF by catheter ablation has provided additional clues to explain AF induction and sustenance. The presence of complex fractionated electrograms (CFAE) and subsequent successful CFAE-directed ablation suggest that diseased atrial myocardium is a necessary substrate for AF maintenance. Atrial remodeling creates differential areas of refractory periods and conduction velocity, which, in turn, creates a suitable environment for AF. This review addresses the complex relationship between remodeled atrial myocardium and reentry and explores the role of CFAEs in AF maintenance.

Use of the Wearable Cardioverter Defibrillator as a Bridge to Implantable Cardioverter Defibrillator.

The wearable cardioverter defibrillator has been shown to be effective in terminating ventricular arrhythmias in patients at risk for sudden cardiac death. There are numerous scenarios in which implant of a permanent implantable cardioverter defibrillator is temporarily contraindicated or not advisable and a wearable cardioverter defibrillator may be beneficial. There are no prospective randomized studies published that provide conclusive guidance toward the use of the wearable cardioverter defibrillator, and thus, patient management needs to be individualized based on the available data.

Management of Device Infections.

The rate of cardiac implantable electronic device (CIED) infection has increased disproportionately to the rate of implantation. Expanded indications for CIED implantation combined with a sicker patient population contribute to this increased rate. Device-related infections are most commonly due to perioperative contamination, and infection risk increases in conjunction with procedural complexity. Early pocket re-exploration and upgrade procedures confer a higher infectious risk. Confirmed CIED infection requires prompt removal of the CIED system combined with antimicrobial therapy. Understanding the risks of CIED infection and using preventive measures are critical. It is hoped that emerging technologies will mitigate CIED infection rates.

His bundle pacing.

His bundle pacing (HBP) has recently emerged as a technique to avoid the negative effects of long-term right ventricular apical pacing. In addition to providing physiologic ventricular activation, HBP has been shown to correct underlying conduction abnormalities in certain patients. Although large prospective, randomized clinical trials have not yet been completed, the available observational clinical data support the safety and efficacy of this technique. Here, we review the physiology of the his bundle (HB) as it relates to HBP, describe the current clinical experience, and discuss future directions of this emerging therapy.

Commotio cordis--sudden cardiac death with chest wall impact.

Commotio cordis (CC), sudden death as a result of a blunt, often innocent-appearing chest wall blow, is being reported with increasing frequency. The clinical spectrum is diverse; however, a substantial number of cases occur in youth athletics. In events that occur during sport, victims are struck by projectiles regarded as standard implements of the game. Sudden death is instantaneous and victims are most often found in ventricular fibrillation (VF). Overall survival is poor; however, successful resuscitation can be achieved with early defibrillation. Autopsy is notable for the absence of any significant cardiac or thoracic injury. Development of an experimental model has allowed for substantial insights into the underlying mechanisms of sudden death. In anesthetized juvenile swine, induction of VF is instantaneous following chest wall blows occurring during a vulnerable window before the T wave peak. Crucial variables including the velocity of impact, impact location, and hardness of the impact object have been identified. Rapid left ventricular (LV) pressure rise following chest impact likely results in activation of ion channels via mechano-electric coupling. The generation of inward current via mechano-sensitive ion channels likely results in augmentation of repolarization and nonuniform myocardial activation, and is the cause of premature ventricular depolarizations that are triggers of VF in CC. While softer-than-standard safety baseballs reduce the risk of CC, commercially available chest protectors are ineffective in preventing CC. The development of more effective chest protectors and more widespread use of automated external defibrillators at youth sporting events are needed.

The Subcutaneous Defibrillator.

The transvenous implantable cardioverter-defibrillator (ICD) has been shown in multiple studies to be effective in the prevention of sudden cardiac death in select populations. The Achilles heel of traditional ICD technology has been the transvenous lead. The subcutaneous ICD provides effective sudden death protection while avoiding lead-related complications of traditional transvenous systems. The subcutaneous ICD is a reasonable option for patients with an ICD indication who do not need bradycardia pacing or cardiac resynchronization therapy.

Subcutaneous Implantable Cardioverter Defibrillator in Patients With Hypertrophic Cardiomyopathy: An Initial Experience.

BACKGROUND: The subcutaneous implantable cardioverter defibrillator (S-ICD) has been developed to avert risks associated with transvenous defibrillator leads. The technology is attractive for younger patients, such as those with hypertrophic cardiomyopathy (HCM). However, there are limited data on S-ICD use in HCM. METHODS AND RESULTS: HCM patients identified at risk for sudden death were considered for S-ICD implantation. Patients were screened for potential oversensing by surface electrocardiography (ECG). At implant, defibrillation threshold (DFT) testing was performed at 65, 50, and 35 joules (J). Twenty-seven patients were considered for S-ICD implantation, and after screening, 23 (85%) remained eligible. The presence of a bundle branch block was associated with screening failure, whereas elevated body mass index (BMI) showed a trend toward association. One patient passed screening at rest, but failed with an ECG obtained after exercise. At implant, the S-ICD terminated ventricular fibrillation (VF) with a 65J shock in all 15 implanted patients and a 50J shock was successful in 12 of 15. A 35J shock terminated VF in 10 of 12 patients. DFT failure at 50 J was associated with a higher BMI. There were no appropriate shocks after a median follow-up of 17.5 (3-35) months, and 1 patient received an inappropriate shock attributable to a temporary reduction in QRS amplitude while bending forward, resulting in oversensing, despite successful screening. CONCLUSIONS: In a high-risk HCM cohort without a pacing indication referred for consideration of an ICD, the majority were eligible for S-ICD. The S-ICD is effective at recognizing and terminating VF at implant with a wide safety margin.

Effectiveness of automated external defibrillators in high schools in greater Boston.

A program using a strategy of donating a single automatic external defibrillator to 35 schools in the Boston area resulted in compliance with American Heart Association guidelines on automatic external defibrillator placement and training and 2 successful resuscitations from sudden cardiac arrest. Participating schools indicated a high degree of satisfaction with the program.

Cardiovascular toxicities of performance-enhancing substances in sports.

Athletes commonly use drugs and dietary supplements to improve athletic performance or to assist with weight loss. Some of these substances are obtainable by prescription or by illegal means; others are marketed as supplements, vitamins, or minerals. Nutritional supplements are protected from Food and Drug Administration regulation by the 1994 US Dietary Supplement Health and Education Act, and manufacturers are not required to demonstrate proof of efficacy or safety. Furthermore, the Food and Drug Administration lacks a regulatory body to evaluate such products for purity. Existing scientific data, which consist of case reports and clinical observations, describe serious cardiovascular adverse effects from use of performance-enhancing substances, including sudden death. Although mounting evidence led to the recent ban of ephedra (ma huang), other performance-enhancing substances continue to be used frequently at all levels, from elementary school children to professional athletes. Thus, although the potential for cardiovascular injury is great, few appropriately designed studies have been conducted to assess the benefits and risks of using performance-enhancing substances. We performed an exhaustive OVID MEDLINE search to Identify all existing scientific data, review articles, case reports, and clinical observations that address this subject. In this review, we examine the current evidence regarding cardiovascular risk for persons using anabolic-androgenic steroids including 2 synthetic substances, tetrahydrogestrinone and androstenedione (andro), stimulants such as ephedra, and nonsteroidal agents such as recombinant human erythropoietin, human growth hormone, creatine, and beta-hydroxy-beta-methylbutyrate.

Device trials in heart failure: a focused summary.

Despite considerable progress in heart failure management with pharmacologic agents, measures to bring about significant improvements in morbidity and mortality are still needed. Cardiac resynchronization therapy (CRT) is a means to enhance myocardial function by stimulating the failing left ventricle at or near the time of right ventricular activation to synchronize ventricular depolarization. Current data from randomized, controlled trials suggest that CRT benefits patients with moderate to severe heart failure and have shown that this therapy significantly reduces mortality and hospital admissions in this group. In addition to CRT, implantable cardioverter-defibrillators have been evaluated in heart failure patients with significantly reduced left ventricular function and have been shown to reduce mortality from sudden cardiac death. This article summarizes recent device trials and discusses how best to apply their results to clinical practice.

Use of antiarrhythmics and implantable cardioverter-defibrillators in congestive heart failure.

As much as half of the mortality in patients with congestive heart failure (CHF) resulting from left ventricular systolic dysfunction is attributable to sudden cardiac death. Thus, the identification of risk and prevention of sudden death are important components of treating this population of patients. Antiarrhythmic drugs have been shown to be either neutral or harmful when studied in patients with prior myocardial infarction and impaired left ventricular function. Amiodarone, when studied in patients with CHF, may be of benefit. This benefit may be more pronounced in patients with nonischemic cardiomyopathy. Implantable cardioverter defibrillators (ICDs) are of clear benefit when used in the primary and secondary prevention of sudden death in selected populations. Studies soon to be completed should clarify the role of the cardioverter-defibrillator in patients with CHF. Antiarrhythmic medications are often used in conjunction with ICDs for a variety of reasons. However, these drugs have the potential to adversely affect defibrillator function, and knowledge of these effects is important when using this strategy.