Apical versus Non-Apical Lead: Is ICD Lead Position Important for Successful Defibrillation?

INTRODUCTION: We aim to compare the acute and long-term success of defibrillation between non-apical and apical ICD lead position. METHODS AND RESULTS: The position of the ventricular lead was recorded by the implanting physician for 2,475 of 2,500 subjects in the Shockless IMPLant Evaluation (SIMPLE) trial, and subjects were grouped accordingly as non-apical or apical. The success of intra-operative defibrillation testing and of subsequent clinical shocks were compared. Propensity scoring was used to adjust for the impact of differences in baseline variables between these groups. There were 541 leads that were implanted at a non-apical position (21.9%). Patients implanted with a non-apical lead had a higher rate of secondary prevention indication. Non-apical location resulted in a lower mean R-wave amplitude (14.0 vs. 15.2, P < 0.001), lower mean pacing impedance (662 ohm vs. 728 ohm, P < 0.001), and higher mean pacing threshold (0.70 V vs. 0.66 V, P = 0.01). Single-coil leads and cardiac resynchronization devices were used more often in non-apical implants. The success of intra-operative defibrillation was similar between propensity score matched groups (89%). Over a mean follow-up of 3 years, there were no significant differences in the yearly rates of appropriate shock (5.5% vs. 5.4%, P = 0.98), failed appropriate first shock (0.9% vs. 1.0%, P = 0.66), or the composite of failed shock or arrhythmic death (2.8% vs. 2.3% P = 0.35) according to lead location. CONCLUSION: We did not detect any reduction in the ICD efficacy at the time of implant or during follow-up in patients receiving a non-apical RV lead.

Left atrial appendage closure with the Amplatzer™ Cardiac Plug: Rationale for a higher degree of device oversizing at implantation.

BACKGROUND: In left atrial appendage (LAA) closure, the correct sizing of the implantable devices is crucial. Data on the time-dependent changes in the shape and positioning of LAA occlusion devices are missing. We analyzed the results of 33 consecutive patients after implantation of an Amplatzer™ Cardiac Plug (ACP) LAA closure device to get more information on the optimal device sizing during implantation. METHODS AND RESULTS: Thirty-three consecutive patients were enrolled in this observational study. ACP implantation was guided by fluoroscopy and three dimensional transesophageal echocardiography (3-D TEE). Device sizing was based on the largest measured diameter of the intended landing zone adding 2-4 mm of device oversizing. Fluoroscopies were performed at 1 day after, and after 3 months, control 3-D TEE was performed 3 months after implantation. The stability of device positioning and shape was matched with the results of 3-D TEE. Patients' mean age was 70.2 ± 8 years; mean CHA2DS2VASc score was 3.8 ± 1.1. According to the manufacture's classification, the post-implant degree of compression of the device-lobe was classified in three categories 1) undercompression "square-like shape" (1 patient); 2) optimal compression "tire-like shape" (20 patients), 3) overcompression "strawberry-like shape" (12 patients). Changes in the degree of device compression by more than one classification class occurred in 18/33 of our patients. A complete loss of device compression ("square-like shape") was observed in 9 patients. Despite the changes in device compression, a complete closure of the LAA was achieved in 32/33 patients. CONCLUSIONS: There is a temporal change in shape and positioning of the ACP within 3 months after implantation. A late decompression of the ACP lobe was observed in 61% of our patients, leading to a complete loss in device compression in 27%. This observation may be the rationale for a higher degree of ACP oversizing during implantation.

The rationale and design of the Shockless IMPLant Evaluation (SIMPLE) trial: a randomized, controlled trial of defibrillation testing at the time of defibrillator implantation.

Defibrillation testing (DT) has been an integral part of defibrillator (implantable cardioverter defibrillator [ICD]) implantation; however, there is little evidence that it improves outcomes. Surveys show a trend toward ICD implantation without DT, which now exceeds 30% to 60% in some regions. Because there is no evidence to support dramatic shift in practice, a randomized trial is urgently needed. The SIMPLE trial will determine if ICD implantation without any DT is noninferior to implantation with DT. Patients will be eligible if they are receiving their first ICD using a Boston Scientific device (Boston Scientific, Natick, MA). Patients will be randomized to DT or no DT at the time of ICD implantation. In the DT arm, physicians will make all reasonable efforts to ensure 1 successful intraoperative defibrillation at 17 J or 2 at 21 J. The first clinical shock in all tachycardia zones will be set to 31 J for all patients. The primary outcome of SIMPLE will be the composite of ineffective appropriate shock or arrhythmic death. The safety outcome of SIMPLE will include a composite of potentially DT-related procedural complications within 30 days of ICD implantation. Several secondary outcomes will be evaluated, including all-cause mortality and heart failure hospitalization. Enrollment of 2,500 patients with 3.5-year mean follow-up will provide sufficient statistical power to demonstrate noninferiority. The study is being performed at approximately 90 centers in Canada, Europe, Israel, and Asia Pacific with final results expected in 2013.

Analysis of interaction of acute atrial overdrive pacing with sleep-related breathing disorder.

Dose-related effects of atrial overdrive pacing (AOP) on sleep-related breathing disorder (SRBD) were studied. Fourteen patients with pacemakers with moderate to severe SRBD (mean screening apnea-hypopnea index [AHI] 35.2 +/- 21.9 events/hour) were randomized to 3 levels of pacing (50, 10, and 20 beats/min greater than the mean nocturnal heart rate) and studied by polysomnography, observing for changes in AHI. At the 2 AOP levels, no significant change was observed in the primary end point of reduction in AHI. Additionally, there was no observed impact on secondary end points of the study. Cyclic variation of heart rate was progressively abolished with higher levels of AOP without affecting AHI. Large variations were observed between the screening and control studies in SRBD indexes in a number of patients. In conclusion, AOP demonstrated no benefit to predominantly obstructive SRBD disorder of at least moderate severity.

Feasibility of automated detection of advanced sleep disordered breathing utilizing an implantable pacemaker ventilation sensor.

OBJECTIVES: This study tested the feasibility of automatically detecting advanced sleep disordered breathing (SDB) from a pacemaker trans-thoracic impedance sensor. BACKGROUND: SDB is prevalent yet under-diagnosed in patients with cardiovascular disease. The potential for automated detection of SDB in patients receiving pacemakers with respiration sensors has not been fully explored. We hypothesized that the trans-thoracic impedance sensor could be utilized for automatic detection of advanced SDB. METHODS: Patients underwent overnight polysomnography (PSG). The pacemaker trans-thoracic impedance signal was simultaneously recorded and time synchronized with the polysomnograph. Cardiovascular health variables were abstracted from medical records. Apnea was defined as cessation of inspiratory airflow lasting 10 seconds or longer. Hypopnea was defined as a reduction of tidal volume of at least 30% from baseline tidal volume, lasting 10 seconds or more. A computer algorithm (PM-A) was developed to automatically detect SDB from the pacemaker impedance sensor data. The performance of automated SDB detection was compared against PSG. RESULTS: Sixty patients (aged 69 +/- 12 years, 45 males) were studied. Advanced SDB (moderate or severe) was diagnosed in 40 patients. Severe SDB (apnea-hypopnea index [AHI]> or = 30) was diagnosed in 32 patients (53%), but only 5 patients had prior diagnosis of the disease. Moderate SDB (30 > AHI > 15) was diagnosed in 8 patients of whom only two were previously diagnosed. Cardiovascular health variables did not predict the presence of advanced SDB. PM-A derived AHI correlated with that of the PSG (r = 0.80, P < 0.01). The algorithm identified patients with advanced SDB with 82% sensitivity and 88% specificity. CONCLUSIONS: It is feasible to automatically measure SDB severity using a pacemaker trans-thoracic impedance sensor. Advanced SDB was frequently undiagnosed in this cohort of pacemaker patients.

Prevention of sustained ventricular tachyarrhythmias in patients with implantable cardioverter-defibrillators-the PREVENT study.

BACKGROUND: In patients with implantable cardioverter-defibrillators (ICDs), 25 to 45% of tachyarrhythmia episodes were initiated by short-long-short RR intervals. METHODS: The prospective multi-center PREVENT study randomized patients implanted with ICDs capable of atrioventricular pacing, in order to compare-using a cross-over design with two 3-month treatment periods-the benefits of 'rate smoothing' (RS) as a 'pause-prevention algorithm' for the prevention of ventricular tachyarrhythmias. RESULT: Follow-up included 219 patients with implanted ICDs, of whom 153 were eligible for analysis as per protocol. Fifty-seven of these patients (38%) had documented episodes of ventricular tachyarrhythmias during the six months follow-up. The total number of sustained ventricular tachyarrhythmia episodes was reduced from 358 with RS Off to 145 with RS On. RS was effective in reducing the number of short-long-short induced sustained ventricular episodes from 100 with RS Off to 40 with RS On. The Wilcoxon-Mann-Whitney point estimator equals 0.66 with a 95% confidence interval from 0.51 to 0.82 (relevant superiority; corresponding p = 0.039). There were no proarrhythmic effects due to rate smoothing within the scope of this study. CONCLUSIONS: 'Rate smoothing' significantly reduced sustained ventricular tachyarrhythmias in ICD patients. There is a relevant superiority of the treatment during the early six months of follow-up.

Microwave, irrigated, pulsed, or conventional radiofrequency energy source: which energy source for which catheter ablation?

The aim of the study was to compare the diameter of endomyocardial lesions induced with the delivery of microwave, cooled, or pulsed energy versus conventional RF energy. In vitro tests were performed in fresh endomyocardial preparations of pig hearts in a 10-L bath of NaCl 0.9% solution at 37 degrees C and constant 1.5 L/min flow. Ablation 7 Fr catheters with 4-mm tip electrodes were used, except for the delivery of microwave energy. Energy delivery time was set to 60 s/50 W in all experiments. Cooled energy delivery was performed with a closed irrigation catheter. Pulsed energy delivery was performed using a special controller with a duty-cycle of 5 ms. Microwave energy was delivered with a 2.5-GHz generator and 10-mm antenna. Electrode temperature and impedance were measured simultaneously. After ablation, lesion length, width, and depth were measured with microcalipers, and volume calculated by a formula for ellipsoid bodies. Each energy delivery mode was tested in ten experiments. The deepest lesions were created with cooled energy delivery, and the largest volume by microwave energy delivery. Pulsed RF produced significantly deeper lesions than conventional RF energy delivery. Cooled or pulsed RF energy delivery created deeper transmural lesions than conventional RF. To create linear lesions at anatomically complex sites (isthmus), microwave energy seemed superior by rapidly creating deep and long lesions.

Quality-of-life in patients with paroxysmal atrial fibrillation after catheter ablation: results of long-term follow-up.

Paroxysmal atrial fibrillation (PAF) significantly impairs patients' quality-of-life (QOL). The effect on QOL of recently developed ablation techniques with curative intention has not been studied. Thirty patients (21 men, age 54.1 +/- 9.5 years) with PAF (duration 5.6 +/- 5.2 years) who failed antiarrhythmic (3.8 +/- 1.2 trials) drug therapy underwent catheter ablation. The follow-up time was 33.9 +/- 11 months. QOL was assessed preablation, 3, 6, 9, 12, 24, and 36 months after catheter ablation. The Medical Outcomes Survey Short-Form (SF-36), scored on a 0-100 scale for each of eight domains: bodily pain, general health, mental health, physical functioning, role-emotional, role-physical, social functioning, and vitality, was used. Simultaneously, patients filled out a symptom-specific checklist (SSC) with seven clinical items scored 1-4 (1 best): dyspnea, nausea, palpitations, anxiety, syncope, presyncope, and NYHA classification. Patients with successful catheter ablation had a significant benefit in seven of eight subscales while patients with recurrence had an impact on QOL in two of eight subscales. Using SSC, a successful ablation influenced scores in all seven items while patients with recurrence had a significant change of clinical symptoms in only one item, anxiety. The subscales of the study group compared to a healthy population show higher scores after 24 months of follow-up. Patients with PAF experience a significant improvement in QOL after a successful catheter ablation. In contrast, in patients with recurrence of PAF the QOL showed improvement to a lesser extent and patients experienced ongoing symptoms.

Prospective randomized comparison of two defibrillation safety margins in unipolar, active pectoral defibrillator therapy.

Various techniques are used to establish defibrillation efficacy and to evaluate defibrillation safety margins in patients with an ICD. In daily practice a safety margin of 10 J is generally accepted. However, this is based on old clinical data and there are no data on safety margins using current ICD technology with unipolar, active pectoral defibrillators. Therefore, a randomized study was performed to test if the likelihood of successful defibrillation at defibrillation energy requirement (DER) + 5 J and + 10 J is equivalent. Ninety-six patients (86 men; age 61.0 +/- 10.3 years; ejection fraction 0.341 +/- 0.132; coronary artery disease [n = 65], dilated cardiomyopathy [n = 18], other [n = 13]) underwent implantation of an active pectoral ICD system with unidirectional current pathway and a truncated, fixed tilt biphasic shock waveform. The defibrillation energy requirement (DER) was determined with the use of a step-down protocol (delivered energy 15, 10, 8, 6, 4, 3, 2 J). The patients were then randomized to three inductions of ventricular fibrillation at implantation and three at predischarge testing with shock strengths programmed to DER + 5 J at implantation and + 10 J at predischarge testing or vice versa. The mean DER in the total study population was 7.88 +/- 2.96 J. The number of defibrillation attempts was 288 for + 5 J and 288 for + 10 J. The rate of successful defibrillation was 94.1% (DER + 5 J) and 98.9% (DER + 10 J; P < 0.01 for equivalence). Charge times for DER + 5 J were significantly shorter than for DER + 10 J (3.65 +/- 1.14 vs 5.45 +/- 1.47 s; P < 0.001). A defibrillation safety margin of DER + 5 J is associated with a defibrillation probability equal to the standard DER + 10 J. In patients in whom short charge times are critical for avoidance of syncope, a safety margin of DER + 5 J seems clinically safe for programming of the first shock energy.

Shock coordinated with high power of morphology electrogram improves defibrillation success in patients with implantable cardioverter defibrillators.

Animal studies have suggested that the success of defibrillation may depend on the properties of VF waveform obtained from the morphology electrogram (ME) at the time of the shock. The reliable identification of depolarization events in the fibrillatory signal can be achieved using adaptive estimation of the instantaneous signal power (P). The aim of this study was to investigate if a high P of the ME (P(ME)) was related to ventricular DFT and if the upslope in ME can be associated with the depolarization event. A total of 575 VF (mean duration 10 s) episodes recorded and stored during ICD implantation in 77 patients with ventricular arrhythmias were used for analysis. The DFT was defined using a double step-down test. The values of P(ME) immediately before pulse delivery (P(shock)) and shock outcomes were registered. The differences between P(shock) of successful and failed defibrillation were tested with the Mann-Whitney U test. The relationship between individual medians of P(shock) (P(med)) and DFT was analyzed using the Kruskall-Wallis H-test. The coincidence between identified depolarization and upslope in ME was tested using the chi-square test. A P value of 0.05 was set for an error probability. The P(shock) in case of failed defibrillation was significantly lower than P(shock) in successful cases by the pulses of any strength (P < 0.001). The test revealed a significant inverse correlation between P(med) and DFT with P < 0.001. The depolarization corresponded to the upslope of ME in 85% of cases. This study demonstrated that a high value of instantaneous power of ME indicates the optimal time for shock delivery. The implementation of this algorithm in ICDs may improve the defibrillation efficacy.