Electrogram morphology discriminators in implantable cardioverter defibrillators: A comparative evaluation.

BACKGROUND: Morphology algorithms are currently recommended as a standalone discriminator in single-chamber implantable cardioverter defibrillators (ICDs). However, these proprietary algorithms differ in both design and nominal programming. OBJECTIVE: To compare three different algorithms with nominal versus advanced programming in their ability to discriminate between ventricular (VT) and supraventricular tachycardia (SVT). METHODS: In nine European centers, VT and SVTs were collected from Abbott, Boston Scientific, and Medtronic dual- and triple-chamber ICDs via their respective remote monitoring portals. Percentage morphology matches were recorded for selected episodes which were classified as VT or SVT by means of atrioventricular comparison. The sensitivity and related specificity of each manufacturer discriminator was determined at various values of template match percentage from receiving operating characteristics (ROC) curve analysis. RESULTS: A total of 534 episodes were retained for the analysis. In ROC analyses, Abbott Far Field MD (area under the curve [AUC]: 0.91; P < .001) and Boston Scientific RhythmID (AUC: 0.95; P < .001) show higher AUC than Medtronic Wavelet (AUC: 0.81; P < .001) when tested for their ability to discriminate VT from SVT. At nominal % match threshold all devices provided high sensitivity in VT identification, (91%, 100%, and 90%, respectively, for Abbott, Boston Scientific, and Medtronic) but contrasted specificities in SVT discrimination (85%, 41%, and 62%, respectively). Abbott and Medtronic's nominal thresholds were similar to the optimal thresholds. Optimization of the % match threshold improved the Boston Scientific specificity to 79% without compromising the sensitivity. CONCLUSION: Proprietary morphology discriminators show important differences in their ability to discriminate SVT. How much this impact the overall discrimination process remains to be investigated.

The role of atrial sensing for new-onset atrial arrhythmias diagnosis and management in single-chamber implantable cardioverter-defibrillator recipients: Results from the THINGS registry.

INTRODUCTION: Atrial tachycardia/fibrillation (AT/AF) episodes are common in implantable cardioverter-defibrillator (ICD) recipients and can be undetected by standard single-chamber devices. This study aims to explore whether a single-lead ICD with an atrial dipole (ICD DX; BIOTRONIK SE & Co, Berlin, Germany) could improve the AT/AF diagnosis and management as compared to standard ICD (ICD VR). METHODS AND RESULTS: We selected patients without AT/AF history from the THINGS registry which included consecutive patients implanted with ICD for standard indications. The ICD VR and the ICD DX groups included 236 (62.8%) and 140 (37.2%) patients, respectively, and had no significant differences in baseline characteristics. During a median follow-up of 27 months, there were 7 AT/AF diagnoses in the ICD VR and 18 in the ICD DX group. The 2-year incidence of AT/AF diagnosis was 3.6% (95% confidence interval [CI]: 1.6%-9.6%) for the ICD VR and 11.4% (95% CI: 6.8%-18.9%) for the ICD DX group (adjusted hazard ratio [HR]: 3.85 [95% CI: 1.58-9.41]; P = .003). Initiation of oral anticoagulation (OAC) due to AT/AF diagnosis was reported in 15 patients. The 2-year incidence of OAC onset was 3.6% (95% CI: 1.6%-7.8%) for the ICD VR and 6.3% (95% CI: 3.0%-12.7%) for ICD DX group (adjusted HR: 1.99 [95% CI: 0.72-5.56]; P = .184). CONCLUSION: We observed that atrial sensing capability in single-chamber ICD patients without evidence of atrial arrhythmias at implant is associated with a greater likelihood of detecting AT/AF episodes. The management of these diagnosed arrhythmias often led to clinical interventions, mainly represented by initiation of OAC therapy.

Seasonal trend of ventricular arrhythmias in a nationwide remote monitoring database of implantable defibrillators and cardiac resynchronization devices.

BACKGROUND: The occurrence of sustained ventricular arrhythmias (SVA) may be influenced by environmental factors. We aimed to investigate annual periodic trends of SVA from the intracardiac electrograms (IEGMs) stored in the implantable defibrillators (ICDs) or cardiac resynchronization therapy (CRT-D) recipients. METHODS: Data from the Home Monitoring Expert Alliance project, a pooled repository of remote monitoring transmissions were analyzed. All IEGMs stored were independently adjudicated by three cardiac electrophysiologists. Periodicity of SVA was evaluated with Generalized Estimating Equations (GEE) models, including periodic terms depending on months in a year. RESULTS: A total of 2936 ICD/CRT-D patients (median age 70 years, 79.6% male) were followed for a median period of 25[13-44] months. Most prevalent structural heart diseases were ischemic (50.8%) and idiopathic dilated (30.6%) cardiomyopathies. Overall, 942 (32.1%) patients experienced a total of 4824 SVA. At GEE analysis, we found a significant periodic component (p = 0.048) when considering both shocked and non-shocked episodes. SVA less frequently occurred in Junes and Julies (3.7 × 1000 patient-month). No evidence of significant periodicity was collected in the subgroup of ischemic patients. CONCLUSIONS: In this RM-based cohort of ICD/CRT-T patients, we observed an annual periodicity of SVA occurrence, with a lower incidence in summer months.

Role of drugs and devices in patients at risk of sudden cardiac death.

The search for effective treatment for preventing sudden cardiac death (SCD) initially started with anti-arrhythmic agents in high-risk patients, but the use of randomized controlled trials clearly led to the conclusion that an approach based on anti-arrhythmic agents is not useful, and sometimes potentially harmful (the risk of arrhythmic death was increased up to 159% in CAST study). Today the approach to SCD prevention includes considering both the setting of patients who have already presented a cardiac arrest or a malignant ventricular tachyarrhythmias (secondary prevention of SCD) and the much broader setting of primary prevention in patients at variable degrees of identifiable risk. For secondary prevention of SCD, implantable cardioverter defibrillation is now the standard of care (the risk of overall mortality may be reduced by 20-31%), and anti-arrhythmic agents, specifically amiodarone, have only a complementary role (for reducing device activations or for preventing atrial fibrillation). For primary prevention of SCD in high-risk patients, cardioverter defibrillators have nowadays specific indications in patients with left ventricular dysfunction (often in combination with cardiac resynchronization therapy), where the risk of overall mortality may be reduced by 23-54%. For the large number of subjects who have some risk of SCD, but are not identified as at high risk of SCD, a series of drugs could exert a favorable effect (beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blocker agents, statins, omega-3 fatty acids and aldosterone antagonists), and for some of them evidence is emerging, from subgroup analysis, of possible SCD prevention capabilities.

Decrease in patient radiation exposure by a tantalum filter during electrophysiological procedures.

AIM: Minimization of X-ray exposure remains a primary issue in cardiac electrophysiology. The effectiveness of X-ray beam filtration during cardiac electrophysiological procedures was therefore studied, using a 0.05-mm-thick tantalum (Ta) foil, as a filter on the primary X-ray beam, to reduce the patient dose without degradation of image quality. METHOD: Preliminary tests were made on a phantom developed with polymethylmethacrylate, catheters, and guide wires. The filter was then used in patients during cardiac procedures. Identical patient images were obtained with and without the Ta filter insertion and the ratio between image quality and patient dose was evaluated. Changes in patient dose and signal-to-noise ratio, as image quality index were measured on the phantom and in patients. RESULTS AND CONCLUSIONS: When the Ta filter was used, the mean effective individual patient dose decreased by 3 to 40% (mean reduction = 27%), with no perceivable difference in image quality estimated by electrophysiologists. This Ta filter may be useful to limit the radiation exposure of patients and operators during cardiac procedures.

Left ventricular pacing by automatic capture verification.

AIMS: To investigate the feasibility of transvenous left ventricular (LV) pacing by autocapture at long term. A reliable measurement of LV evoked response (ER) is the pivotal requirement for beat-to-beat detection of ventricular capture and automatic output adjustment. METHODS AND RESULTS: Seven patients with accepted class I indication to permanent cardiac pacing received a DDDR pacemaker with automatic output adjustment based on beat-to-beat capture verification (Insignia Ultra 1290, Guidant), whose ventricular port was connected to a LV lead placed in a branch of the coronary sinus. The device allows LV threshold trending, performing a threshold test every 21 h, and diagnoses acute and non-acute issues of ER detection during follow up. Average follow up after implantation was 34 +/- 6 months (range 28-45, median 34). Left ventricular pacing threshold showed an increase from implantation (1.2 +/- 0.4 V at 0.4 ms) that peaked at week 4 (1.6 +/- 0.7 V at 0.4 ms), and returned to baseline (1.1 +/- 0.5 at 0.4 ms) by the end of the 7th week. Autocapture performance at long term, as assessed by the trend of LV threshold and of ER diagnostic issues, did not show any pitfall. CONCLUSIONS: Our observations support the feasibility and safety of capture verification during LV pacing alone. A possible application of this pacing technology could be biventricular stimulation.

Potential of non-antiarrhythmic drugs to provide an innovative upstream approach to the pharmacological prevention of sudden cardiac death.

Sudden cardiac death (SCD) is the most common cause of death and often occurs in low-risk patients. Present prevention strategies, mainly confined to high-risk subjects (proposed implantable cardioverter defibrillators recipients), have a limited effect on SCD burden in the general population. A relatively unexplored strategy for extending SCD prevention could imply targeting the early (upstream) processes of the complex cascade leading to SCD by non-antiarrhythmic drugs (i.e., beta-blockers, aldosterone antagonists, angiotensin-converting enzyme inhibitors, angiotensin receptor-blocker agents, statins and omega-3 fatty acids). In this innovative pharmacological perspective, agents with upstream effects may also be used in high-risk patients in association with a strictly downstream intervention, such as the implantable cardioverter defibrillator, in an attempt to obtain an additive/synergetic effect.

Cardiac resynchronization therapy in clinical practice: need for electrical, mechanical, clinical and logistic synchronization.

Considering the relatively short history of cardiac resynchronization therapy (CRT), the amount of available evidence of efficacy is impressive, and effectiveness studies are now required. Transfer of our experimentally gained knowledge into the real world raises issues that call for synchronization among the many specialists involved in chronic heart failure (CHF) management and CRT decision making. From an economic perspective, the demonstrated ability of CRT to reduce hospitalizations could help ease the burden on health systems derived from the growing incidence of CHF. Recent American College of Cardiology/American Heart Association guideline revisions should encourage a synchronized approach to rational deployment of CRT in selected patients. Nevertheless, current QRS criteria for CRT candidacy do not directly address the key issue of identification of patients with a pacing-correctable mechanical dyssynchrony (and in clinical trials, 25-30% of implanted patients did not respond to CRT). Echocardiography could become an important adjunct (or even an alternative) to QRS duration for patient selection; routine implementation would require use of straightforward, reproducible measurements, possibly obtainable on standard equipment. Echocardiography could also help optimize site location, although this would not eliminate lead placement problems. A series of issues remain open for investigation, including the potential of CRT in patients with atrial fibrillation, impact of devices with defibrillation ability, effects of electrical/pharmacological tailoring, need for confirmation that efficacy of CRT extends into the long term and possible use of CRT in mild CHF. Interdisciplinary synchronization in the various phases of CRT (screening, proposing, implementing, optimizing and monitoring) should eventually help develop a coordinated system for patient referral.