Margaret Hood

An Entirely Subcutaneous Implantable Cardioverter–Defibrillator

BACKGROUND Implantable cardioverter-defibrillators (ICDs) prevent sudden death from cardiac causes in selected patients but require the use of transvenous lead systems. To eliminate the need for venous access, we designed and tested an entirely subcutaneous ICD system. METHODS First, we conducted two short-term clinical trials to identify a suitable device configuration and assess energy requirements. We evaluated four subcutaneous ICD configurations in 78 patients who were candidates for ICD implantation and subsequently tested the best configuration in 49 additional patients to determine the subcutaneous defibrillation threshold in comparison with that of the standard transvenous ICD. Then we evaluated the long-term use of subcutaneous ICDs in a pilot study, involving 6 patients, which was followed by a trial involving 55 patients. RESULTS The best device configuration consisted of a parasternal electrode and a left lateral thoracic pulse generator. This configuration was as effective as a transvenous ICD for terminating induced ventricular fibrillation, albeit with a significantly higher mean (+/-SD) energy requirement (36.6+/-19.8 J vs. 11.1+/-8.5 J). Among patients who received a permanent subcutaneous ICD, ventricular fibrillation was successfully detected in 100% of 137 induced episodes. Induced ventricular fibrillation was converted twice in 58 of 59 patients (98%) with the delivery of 65-J shocks in two consecutive tests. Clinically significant adverse events included two pocket infections and four lead revisions. After a mean of 10+/-1 months, the device had successfully detected and treated all 12 episodes of spontaneous, sustained ventricular tachyarrhythmia. CONCLUSIONS In small, nonrandomized studies, an entirely subcutaneous ICD consistently detected and converted ventricular fibrillation induced during electrophysiological testing. The device also successfully detected and treated all 12 episodes of spontaneous, sustained ventricular tachyarrhythmia. (ClinicalTrials.gov numbers, NCT00399217 and NCT00853645.)

Safety and Efficacy of a Totally Subcutaneous Implantable-Cardioverter Defibrillator

Background— The most frequent complications associated with implantable cardioverter-defibrillators (ICDs) involve the transvenous leads. A subcutaneous implantable cardioverter-defibrillator (S-ICD) has been developed as an alternative system. This study evaluated the safety and effectiveness of the S-ICD System (Cameron Health/Boston Scientific) for the treatment of life-threatening ventricular arrhythmias (ventricular tachycardia/ventricular fibrillation). Methods and Results— This prospective, nonrandomized, multicenter trial included adult patients with a standard indication for an ICD, who neither required pacing nor had documented pace-terminable ventricular tachycardia. The primary safety end point was the 180-day S-ICD System complication-free rate compared with a prespecified performance goal of 79%. The primary effectiveness end point was the induced ventricular fibrillation conversion rate compared with a prespecified performance goal of 88%, with success defined as 2 consecutive ventricular fibrillation conversions of 4 attempts. Detection and conversion of spontaneous episodes were also evaluated. Device implantation was attempted in 321 of 330 enrolled patients, and 314 patients underwent successful implantation. The cohort was followed for a mean duration of 11 months. The study population was 74% male with a mean age of 52±16 years and mean left ventricular ejection fraction of 36±16%. A previous transvenous ICD had been implanted in 13%. Both primary end points were met: The 180-day system complication-free rate was 99%, and sensitivity analysis of the acute ventricular fibrillation conversion rate was >90% in the entire cohort. There were 38 discrete spontaneous episodes of ventricular tachycardia/ventricular fibrillation recorded in 21 patients (6.7%), all of which successfully converted. Forty-one patients (13.1%) received an inappropriate shock. Conclusions— The findings support the efficacy and safety of the S-ICD System for the treatment of life-threatening ventricular arrhythmias. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01064076.

Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry

Aims The totally subcutaneous implantable-defibrillator (S-ICD) is a new alternative to the conventional transvenous ICD system to minimize intravascular lead complications. There are limited data describing the long-term performance of the S-ICD. This paper presents the first large international patient population collected as part of the EFFORTLESS S-ICD Registry. Methods and results The EFFORTLESS S-ICD Registry is a non-randomized, standard of care, multicentre Registry designed to collect long-term, system-related, clinical, and patient reported outcome data from S-ICD implanted patients since June 2009. Follow-up data are systematically collected over 60-month post-implant including Quality of Life. The study population of 472 patients of which 241 (51%) were enrolled prospectively has a mean follow-up duration of 558 days (range 13–1342 days, median 498 days), 72% male, mean age of 49 ± 18 years (range 9–88 years), 42% mean left ventricular ejection fraction. Complication-free rates were 97 and 94%, at 30 and 360 days, respectively. Three hundred and seventeen spontaneous episodes were recorded in 85 patients during the follow-up period. Of these episodes, 169 (53%) received therapy, 93 being for Ventricular Tachycardia/Fibrillation (VT/VF). One patient died of recurrent VF and severe bradycardia. Regarding discrete VT/VF episodes, first shock conversion efficacy was 88% with 100% overall successful clinical conversion after a maximum of five shocks. The 360-day inappropriate shock rate was 7% with the vast majority occurring for oversensing (62/73 episodes), primarily of cardiac signals (94% of oversensed episodes). Conclusion The first large cohort of real-world data from an International patient S-ICD population demonstrates appropriate system performance with clinical event rates and inappropriate shock rates comparable with those reported for conventional ICDs. Clinical trial registration URL: http://www.clinicaltrials.gov. Unique identifier NCT01085435.

Adenosine versus verapamil in the treatment of supraventricular tachycardia: A randomized double-crossover trial☆

The safety and efficacy of verapamil and adenosine in the acute termination of supraventricular tachycardia were compared in a randomized double-crossover trial. Of 32 eligible patients with either spontaneous or induced narrow complex tachycardia, seven (22%) patients experienced conversion to sinus rhythm with carotid sinus massage. The other 25 patients were randomly assigned to receive either adenosine (n = 14) or verapamil (n = 11). Relative drug efficacies were 100% for adenosine versus 73% for verapamil, p = NS. Adenosine given at less than or equal to 120 micrograms/kg caused conversion in 12 (86%) of 14 patients. The other two patients required 20 mg adenosine for conversion. After conversion the systolic blood pressure increased significantly in the adenosine group but not in the verapamil group. Reinitiation of tachycardia occurred in two (14%) of 14 patients randomized to the adenosine group. Serious adverse hemodynamic effects were observed in one (9%) of 11 patients randomized to verapamil. The incidence of conversion arrhythmias was similar in both treatment groups (adenosine 57%, verapamil 50%, p = NS).

The learning curve associated with the introduction of the subcutaneous implantable defibrillator

Abstract Aims The subcutaneous implantable cardioverter defibrillator (S-ICD) was introduced to overcome complications related to transvenous leads. Adoption of the S-ICD requires implanters to learn a new implantation technique. The aim of this study was to assess the learning curve for S-ICD implanters with respect to implant-related complications, procedure time, and inappropriate shocks (IASs). Methods and results In a pooled cohort from two clinical S-ICD databases, the IDE Trial and the EFFORTLESS Registry, complications, IASs at 180 days follow-up and implant procedure duration were assessed. Patients were grouped in quartiles based on experience of the implanter and Kaplan–Meier estimates of complication and IAS rates were calculated. A total of 882 patients implanted in 61 centres by 107 implanters with a median of 4 implants (IQR 1,8) were analysed. There were a total of 59 patients with complications and 48 patients with IAS. The complication rate decreased significantly from 9.8% in Quartile 1 (least experience) to 5.4% in Quartile 4 (most experience) (P = 0.02) and non-significantly for IAS from 7.9 to 4.8% (P = 0.10). Multivariable analysis demonstrated a hazard ratio of 0.78 (P = 0.045) for complications and 1.01 (P = 0.958) for IAS. Dual-zone programming increased with experience of the individual implanter (P < 0.001), which reduced IAS significantly in the multivariable model (HR 0.44, P = 0.01). Procedure time decreased from 75 to 65 min (P < 0.001). The complication rate and procedure time stabilized after Quartile 2 (>13 implants). Conclusion There is a short and significant learning curve associated with physicians adopting the S-ICD. Performance stabilizes after 13 implants.

Community detection of long QT syndrome with a clinical registry: An alternative to ECG screening programs?

BACKGROUND Long QT syndrome (LQTS) prevalence is estimated at 4 of 10,000 based on community electrocardiogram (ECG) screening, about which there is disagreement regarding efficacy, accuracy, cost-effectiveness, and practicality. Family studies of autosomal dominant conditions such as LQTS have revealed 8-9 gene-positive family members per proband. OBJECTIVE To evaluate a cardiac/genetic registry and family screening program as a tool to identify LQTS in the community. METHODS Possible LQTS probands were referred to the New Zealand Cardiac Inherited Disease service. The registry was first established in the northern region (population 2.03 million), including central Auckland (population 0.46 million). After clinical evaluation, genetic testing and family cascade screening were initiated. Genotype-positive individuals were classified as definite LQTS, and others were classified as definite or probable LQTS by clinical and ECG criteria. RESULTS One hundred twelve probands were identified (presentation: 7 sudden death, 82 cardiac event, 16 ECG abnormality, and 7 sudden death of a family member). Following cascade screening, 309 patients with LQTS were identified (248 definite and 61 probable). Two hundred twenty patients had LQTS-causing mutations identified (120 [55%] LQT1, 78 [35%] LQT2, 19 [9%] LQT3, 1 [0.5%] LQT 5, and 2 [1%] LQT7). Thus far, an average of 2.1 definitely or probably affected family members have been identified per proband. The community detection rate is 1.5 of 10,000 for the whole region and 2.2 of 10,000 in Auckland. CONCLUSIONS A high level of community detection of LQTS is possible using a clinical registry. With adequate resourcing, this has the potential to be an effective alternative to community ECG screening.

Evaluation of subcutaneous ICD early performance in hypertrophic cardiomyopathy from the pooled EFFORTLESS and IDE cohorts

BACKGROUND The subcutaneous implantable cardioverter-defibrillator (S-ICD) is a potential alternative to transvenous systems in hypertrophic cardiomyopathy (HCM) where lead complications are a significant issue. OBJECTIVES To compare the S-ICD efficacy of defibrillation threshold (DFT) testing, arrhythmia therapy, and complications in HCM versus non-HCM patients. METHODS Outcomes of patients with HCM implanted with S-ICD were compared to non-HCM S-ICD recipients using pooled data from a total of 872 subjects enrolled in the EFFORTLESS Registry and US IDE study. RESULTS The cohort included 99 HCM (75% male) and 773 non-HCM (72% male) patients with a median follow-up of 637 days. The HCM cohort was younger and more likely to receive a primary-prevention S-ICD (88.5% vs 67.5%, P < .0001). During implant testing, successful defibrillation at ≤80 J was achieved in 98.9% of HCM and 98.5% of non-HCM patients. One year postoperative complication-free rates were similar: 92.7% in HCM (with no lead complications) versus 89.5% in non-HCM. There were 3 appropriate shocks for ventricular tachycardia in 3 HCM patients that were all converted by the first shock. Overall final shock conversion efficacy was 100% in HCM versus 98% in non-HCM (P = ns). Inappropriate shocks occurred in 12.5% of HCM patients and 10.3% of non-HCM patients (P = ns), being reduced by 47% using dual-zone programming. CONCLUSION These initial data indicate the S-ICD is safe and effective in patients with HCM who are at high risk of ventricular arrhythmias and pass preimplantation electrocardiogram screening. Inappropriate shocks were mainly due to T-wave oversensing, but there were no lead complications requiring reintervention.

Atrial Pacing Should Be Used More Frequently in Sinus Node Disease

Background: Single lead atrial (AAI(R)) pacing for sick sinus syndrome provides physiological pacing and is less expensive than a dual chamber system. Compared with ventricular‐based pacing, it maintains the normal cardiac depolarization sequence, is associated with less atrial fibrillation and heart failure, and avoids pacemaker syndrome. We sought whether it is possible to select patients for AAI(R) pacing with a low likelihood of subsequent ventricular pacing, and whether this approach was cost‐effective.

Longevity of the Subcutaneous Implantable Defibrillator Long-Term Follow-Up of the European Regulatory Trial Cohort

Background—The recent advent of subcutaneous implantable cardioverter defibrillators (S-ICDs) has provided investigators with a safe and effective new therapy in patients at risk of sudden cardiac death. At present, no data are available with regard to the longevity of these new devices. This study evaluated the longevity of the S-ICD system. Methods and Results—All patients enrolled in the European Regulatory Trial were included in the analysis. During follow-up, time and causes of device replacement or explantation were assessed and categorized. Device longevity was estimated using Kaplan–Meier analysis. Fifty-five patients were followed for a median of 5.8 years. During follow-up, 26 (47%) patients underwent device replacement and 5 (9%) underwent device explantation. Median time to replacement was 5.0 years (Q1–Q3, 4.4–5.6 years). Replacement was caused by battery depletion in 25 patients (92%), of which 5 within 1.5 years because of premature battery depletion, and by infection in 1 patient (2%). Replacement for a transvenous ICD system was required in 4 patients (7%) because of ineffective defibrillation in 1 (0.003 per patient-year), need for resynchronization therapy in 2 (0.01 per patient-year), and for antibradycardia pacing in 1 (0.003 per patient-year). At 5 years follow-up, 71% of devices were still in service. Conclusions—This study provides the first estimate of S-ICD system longevity since its introduction in clinical practice. Median longevity of the first generation S-ICD system was 5.0 years. The majority of devices were replaced because of battery depletion. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01117792.

Pacemaker Use in New Zealand – Data From the New Zealand Implanted Cardiac Device Registry (ANZACS-QI 15)

BACKGROUND The New Zealand Cardiac Implanted Device Registry (Device) has recently been developed under the auspices of the New Zealand Branch of the Cardiac Society of Australia and New Zealand. This study describes the initial Device registry cohort of patients receiving a new pacemaker, their indications for pacing and their perioperative complications. METHODS The Device Registry was used to audit patients receiving a first pacemaker between 1st January 2014 and 1st June 2015. RESULTS We examined 1611 patients undergoing first pacemaker implantation. Patients were predominantly male (59%), and had a median age of 70 years. The most common symptom for pacemaker implantation was syncope (39%), followed by dizziness (30%) and dyspnoea (12%). The most common aetiology for a pacemaker was a conduction tissue disorder (35%), followed by sinus node dysfunction (22%). Atrioventricular (AV) block was the most common ECG abnormality, present in 44%. Dual chamber pacemakers were most common (62%), followed by single chamber ventricular pacemakers (34%), and cardiac resynchronisation therapy - pacemakers (CRT-P) (2%). Complications within 24hours of the implant procedure were reported in 64 patients (3.9%), none of which were fatal. The most common complication was the need for reoperation to manipulate a lead, occurring in 23 patients (1.4%). CONCLUSION This is the first description of data entered into the Device registry. Patients receiving a pacemaker were younger than in European registries, and there was a low use of CRT-P devices compared to international rates. Complications rates were low and compare favourably to available international data.