Successful defibrillation testing in patients undergoing elective subcutaneous implantable cardioverter-defibrillator generator replacement.

AIMS: After implantation of a subcutaneous implantable cardioverter-defibrillator (S-ICD), a defibrillation test (DFT) is performed to ensure that the device can effectively detect and terminate the induced ventricular arrhythmia. Data on DFT efficacy at generator replacement are scarce with a limited number of patients and conflicting results. This study evaluates conversion efficacy during DFT at elective S-ICD generator replacement in a large cohort from our tertiary centre. METHODS AND RESULTS: Retrospective data of patients who underwent an S-ICD generator replacement for battery depletion with subsequent DFT between February 2015 and June 2022 were collected. Defibrillation test data were collected from both implant and replacement procedures. PRAETORIAN scores at implant were calculated. Defibrillation test was defined unsuccessful when two conversions at 65 J failed. A total of 121 patients were included. The defibrillation test was successful in 95% after the first and 98% after two consecutive tests. This was comparable with success rates at implant, despite a significant rise in shock impedance (73 ± 23 vs. 83 ± 24 Ω, P < 0.001). Both patients with an unsuccessful DFT at 65 J successfully converted with 80 J. CONCLUSION: This study shows a high DFT conversion rate at elective S-ICD generator replacement, which is comparable to conversion rates at implant, despite a rise in shock impedance. Evaluating device position before generator replacement may be recommended to optimize defibrillation success at generator replacement.

Acute shock efficacy of the subcutaneous implantable cardioverter-defibrillator according to the implantation technique.

BACKGROUND: The traditional technique for subcutaneous implantable cardioverter defibrillator (S-ICD) implantation involves three incisions and a subcutaneous (SC) pocket. An intermuscular (IM) 2-incision technique has been recently adopted. AIMS: We assessed acute defibrillation efficacy (DE) of S-ICD (DE ≤65 J) according to the implantation technique. METHODS: We analyzed consecutive patients who underwent S-ICD implantation and DE testing at 53 Italian centers. Regression analysis was used to determine the association between DFT and implantation technique. RESULTS: A total of 805 patients were enrolled. Four groups were assessed: IM + 2 incisions (n = 546), SC + 2 incisions (n = 133), SC + 3 incisions (n = 111), and IM + 3 incisions (n = 15). DE was ≤65 J in 782 (97.1%) patients. Patients with DE ≤65 J showed a trend towards lower body mass index (25.1 vs. 26.5; p = .12), were less frequently on antiarrhythmic drugs (13% vs. 26%; p = .06) and more commonly underwent implantation with the 2-incision technique (85% vs. 70%; p = .04). The IM + 2-incision technique showed the lowest defibrillation failure rate (2.2%) and shock impedance (66 Ohm, interquartile range: 57-77). On multivariate analysis, the 2-incision technique was associated with a lower incidence of shock failure (hazard ratio: 0.305; 95% confidence interval: 0.102-0.907; p = .033). Shock impedance was lower with the IM than with the SC approach (66 vs. 70 Ohm p = .002) and with the 2-incision than the 3-incision technique (67 vs. 72 Ohm; p = .006). CONCLUSIONS: In a large population of S-ICD patients, we observed a high defibrillation success rate. The IM + 2-incision technique provides lower shock impedance and a higher likelihood of successful defibrillation.

Implantation technique and optimal subcutaneous defibrillator chest position: a PRAETORIAN score-based study.

AIMS: The traditional technique for subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation involves three incisions and a subcutaneous pocket. Recently, a two-incision and intermuscular (IM) technique has been adopted. The PRAETORIAN score is a chest radiograph-based tool that predicts S-ICD conversion testing. We assessed whether the S-ICD implantation technique affects optimal position of the defibrillation system according to the PRAETORIAN score. METHODS AND RESULTS: We analysed consecutive patients undergoing S-ICD implantation. The χ2 test and regression analysis were used to determine the association between the PRAETORIAN score and implantation technique. Two hundred and thirteen patients were enrolled. The S-ICD generator was positioned in an IM pocket in 174 patients (81.7%) and the two-incision approach was adopted in 199 (93.4%). According to the PRAETORIAN score, the risk of conversion failure was classified as low in 198 patients (93.0%), intermediate in 13 (6.1%), and high in 2 (0.9%). Patients undergoing the two-incision and IM technique were more likely to have a low (<90) PRAETORIAN score than those undergoing the three-incision and subcutaneous technique (two-incision: 94.0% vs. three-incision: 78.6%; P = 0.004 and IM: 96.0% vs. subcutaneous: 79.5%; P = 0.001). Intermuscular plus two-incision technique was associated with a low-risk PRAETORIAN score (hazard ratio 3.76; 95% confidence interval 1.01-14.02; P = 0.04). Shock impedance was lower in PRAETORIAN low-risk patients than in intermediate-/high-risk categories (66 vs. 96 Ohm; P = 0.001). The PRAETORIAN score did not predict shock failure at 65 J. CONCLUSION: In this cohort of S-ICD recipients, combining the two-incision technique and IM generator implantation yielded the lowest PRAETORIAN score values, indicating optimal defibrillation system position. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/ Identifier: NCT02275637.

High defibrillation threshold with right-sided ICD implantation was resolved by a dual coil lead via persistent left superior vena cava.

Persistent left superior vena cava (PLSVC) can be problematic when device implantation is scheduled from the left side because of the technical difficulty in delivering leads. Right-sided implantation is an alternative method, but there is a risk of a high defibrillation threshold (DFT). Transvenous implantation of an implantable cardioverter defibrillator (ICD) was scheduled for a 54-year-old man with idiopathic dilated cardiomyopathy and monomorphic non-sustained ventricular tachycardia, but computed tomography revealed the presence of a PLSVC. Right-sided ICD implantation was performed first; however, an ICD shock at 35 J failed to terminate the induced ventricular fibrillation (VF). Re-implantation via the PLSVC by a left subclavian approach with a dual coil lead was performed next. The dual coil right ventricular lead was successfully implanted via the PLSVC, and the induced VF was terminated by a single shock at 25 J. In the present case, the proximal coil was located in the coronary sinus (CS) and it enabled an antero-posterior defibrillation vector across the left ventricle. In addition to the re-location of the ICD generator from the right side to the left side, the new positioning of the proximal coil inside the CS is likely to have contributed to the great improvement of the DFT. .

Is 40 Joules Enough to Successfully Defibrillate With Subcutaneous Implantable Cardioverter-Defibrillators?

OBJECTIVES: This study evaluated the efficacy of conversion test performed at 40 J (defibrillation margin ≥40 J), and factors potentially associated with test failure were identified. BACKGROUND: Current subcutaneous implantable cardioverter-defibrillator (S-ICD) devices deliver a maximum of 80 J. Functional defibrillation testing is recommended at S-ICD implantation, and it is usually conducted by delivering a shock energy of 65 J to ensure a safety defibrillation margin ≥15 J. Although high rates of successful conversion were reported at 65 J, limited data exist on the defibrillation margin extent. METHODS: Ventricular fibrillation was induced and conversion test was performed by delivering a 40-J shock in 308 patients. Success was defined as termination of ventricular fibrillation by the first shock delivered in standard polarity. The S-ICD system positioning was evaluated with the PRAETORIAN score using bidirectional chest X-rays. RESULTS: The generator was positioned in an intermuscular pocket in 301 patients (98%) and the lead was implanted by means of a 2-incision technique. The PRAETORIAN score was <90 (low risk of conversion failure) in 293 (95%) patients. Overall, ventricular fibrillation termination occurred in 259 (84%) patients with 40 J. Male gender (odds ratio [OR]: 3.79; 95% confidence interval [CI]: 1.09 to 13.14; p = 0.036), body mass index (OR: 1.09; 95% CI: 1.01 to 1.19; p = 0.036), dilated cardiomyopathy with reduced ejection fraction (OR: 0.42; 95% CI: 0.20 to 0.87; p = 0.019), and PRAETORIAN score >50 (OR: 2.93; 95% CI: 1.26 to 6.83; p = 0.013) were independently associated with conversion failure. CONCLUSIONS: The authors showed a high rate of defibrillation success with 40-J shocks in S-ICD systems implanted by means of modern surgical techniques. The variables associated with shock failure were male gender, higher body mass index, and suboptimal device position according to the PRAETORIAN score.

Absence of shock therapy related to improper sensing of noise on the defibrillation test during subcutaneous implantable cardioverter-defibrillator implantation: a case report.

BACKGROUND: Subcutaneous implantable cardioverter-defibrillator (S-ICD) represents an efficient alternative to transvenous ICD in patients who do not require pacing. The intraoperative defibrillation test (DFT) is recommended during S-ICD implantation to confirm appropriate sensing and successful 65-J termination of induced ventricular fibrillation (VF). However, few cases of oversensing of noise inhibiting therapies have been reported. CASE SUMMARY: We report the case of a 50-year-old man who underwent S-ICD implantation for secondary prevention of sudden cardiac death. Immediately after S-ICD implantation, VF was induced using a 50-Hz burst; however, shock was not delivered owing to sustained noise on the electrogram in the primary vector. Therefore, an external rescue shock was needed at 150 J. We changed the sensing vector from primary to secondary and performed a second DFT. The S-ICD could deliver an appropriate shock and was able to successfully terminate VF without noise markers in the secondary vector. During the second DFT, one back-up pacing was delivered after the shock; the sensing vector then automatically switched from the secondary to the alternate vector. However, noise was observed in the alternate vector despite sinus rhythm restoration. DISCUSSION: The present case demonstrated that noise was recorded in two different vectors during DFT, possibly supporting the hypothesis that the muscle spasm of the diaphragm induced by the 50-Hz burst causes oversensing of noise by the S-ICD.

Time to therapy delivery and effectiveness of the subcutaneous implantable cardioverter-defibrillator.

BACKGROUND: At the time of subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation, successful termination of ventricular fibrillation (VF) is confirmed. A previous study reported cases of prolonged time to therapy during defibrillation testing. OBJECTIVES: We sought to evaluate the time to therapy, identify possible predictors of delay, and investigate the impact of delayed therapy on VF conversion. METHODS: We analyzed consecutive patients with S-ICDs who underwent initial conversion testing at a shock energy of 65 J in 53 Italian centers. RESULTS: We analyzed 570 patients (467 [82%] male; mean age 48 ± 15 years; mean body mass index 25 ± 6 kg/m2; mean ejection fraction 47% ± 17%). General anesthesia was used in 165 (29%) of patients, with sub- or intermuscular positioning of the generator in (422; 74%). Cardioversion was successful at 65 J in 557 (97.7%) of patients. In 12 patients (2.1%) the shock did not convert VF, and in 1 patient the shock was not delivered because of noise from entrapped subcutaneous air. All failures were successfully managed by reprogramming or repositioning the device. The mean time to therapy was 15 ± 3 seconds, and it exceeded 18 seconds in 51 patients (9%). Independent predictors of delayed therapy (18 seconds) were ejection fraction (odds ratio [OR] 0.98; 95% confidence interval [CI] 0.96-0.99; P = .016) and a 2× gain programmed (OR 3.66; 95% CI 1.44-9.30; P = .006). Effectiveness at 65 J was not associated with time to therapy (OR 1.13; 95% CI 0.97-1.32; P = .122). CONCLUSION: In this analysis of a large population of patients with S-ICDs, delayed therapy during defibrillation testing occurred less frequently than previously reported and had no effect on VF conversion success. Delayed therapies seemed more common when a vector with a 2× gain was programmed.

Successful defibrillation verification in subcutaneous implantable cardioverter-defibrillator recipients by low-energy shocks.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an effective alternative to the transvenous one. Defibrillation efficacy depends on maximum device output and on the optimal device location at device implantation. HYPOTHESIS: We sought to investigate the defibrillation safety margin in real life clinical practice. METHODS: We sought to understand what is the efficacy of induced ventricular fibrillation (VF) termination at S-ICD implantation using lower energies than the recommended 65 J. RESULTS: Sixty-four consecutive S-ICD recipients underwent VF termination attempts at implantation with energies ranging from 20 to 50 J. Overall, VF termination occurred in 84% of patients with ≤40 J, in 88% with 45 J, and in 100% with 60 J. Intermuscular S-ICD placement was associated with 94% VF termination at ≤40 J. An ejection fraction <35% was associated to higher energy requirement for defibrillation; however, an intermuscular S-ICD placement conferred 90% defibrillation efficacy at 31 ± 5 J in this patients subset. CONCLUSIONS: This is a hypothesis-generating observation that prompts a methodologically correct investigation to prove that a 60 J output S-ICD can provide an adequate safety margin to terminate VF in clinical practice. This would enable superior device longevity and/or device downsizing for pediatric/small size patients.

Subcutaneous implantable cardioverter defibrillator implantation: An analysis of Italian clinical practice and its evolution.

BACKGROUND: The subcutaneous implantable cardioverter defibrillator (S-ICD) is a relatively novel alternative to the transvenous ICD for the treatment of life-threatening ventricular arrhythmias, and is currently used in the clinical practice of several centers. The aim of this analysis was to describe current Italian practice regarding S-ICD implantation and its evolution over the years. METHODS: We analyzed 607 consecutive patients (78% male, 48 ±â€¯16 years) who underwent S-ICD implantation in 39 Italian centers from 2013 to 2017. RESULTS: Structural cardiomyopathy was present in 78% of patients and 30% of patients received their device for secondary prevention. The proportion of patients with dilated cardiomyopathy and with left ventricular ejection fraction ≤35% increased from ≤2014 to 2017 (from 38% to 58%, from 33% to 53%, respectively; both p < 0.05). Almost all procedures (97%) were performed in electrophysiology laboratories. Over the last 4 years, the 2-incision implantation technique has been widely adopted, with sub- or inter-muscular positioning of the generator, under local anesthesia or deep sedation (≤2014 versus 2017: all p < 0.001). Defibrillation testing was performed in 81% of patients. Shock energy of ≤65 J was successful in 93.9% of patients and the overall cardioversion success rate at ≤80 J was 99.8%. CONCLUSIONS: Our analysis confirmed that the S-ICD continues to be preferentially used in specific patients (younger, less frequently with dilated cardiomyopathy and low ejection fraction.). Nonetheless, we noted a trend toward the wider use of S-ICD in patients with dilated cardiomyopathy and systolic dysfunction over the years. Novel approaches have been adopted while the acute efficacy of the system has remained stably high.

Critical analysis of ineffective post implantation implantable cardioverter-defibrillator-testing.

AIM: To test of the implantable-cardioverter-defibrillator is done at the time of implantation. We investigate if any testing should be performed. METHODS: All consecutive patients between January 2006 and December 2008 undergoing implantable cardioverter-defibrillator (ICD) implantation/replacement (a total of 634 patients) were included in the retrospective study. RESULTS: Sixteen patients (2.5%) were not tested (9 with LA/LV-thrombus, 7 due to operator's decision). Analyzed were 618 patients [76% men, 66.4 + 11 years, 24% secondary prevention (SP), 46% with left ventricular ejection fraction (LVEF) < 20%, 56% had coronary artery disease (CAD)] undergoing defibrillation safety testing (SMT) with an energy of 21 + 2.3 J. In 22/618 patients (3.6%) induced ventricular fibrillation (VF) could not be terminated with maximum energy of the ICD. Six of those (27%) had successful SMT after system modification or shock lead repositioning, 14 patients (64%) received a subcutaneous electrode array. Younger age (P = 0.0003), non-CAD (P = 0.007) and VF as index event for SP (P = 0.05) were associated with a higher incidence of ineffective SMT. LVEF < 20% and incomplete revascularisation in patients with CAD had no impact on SMT. CONCLUSION: Defibrillation testing is well-tolerated. An ineffective SMT occurred in 4% and two third of those needed implantation of a subcutaneous electrode array to pass a SMT > 10 J.

The association between defibrillation shock energy and acute cardiac damage in patients with implantable cardioverter defibrillators.

BACKGROUND: The aim of this study was to establish a minimally invasive defibrillation testing (DT) protocol for patients with implantable cardioverter defibrillators (ICDs). METHODS: Two different energy DTs were performed, immediately after (15 J-DT) and 7 days after (≤10 J-DT) device implantation, in 20 consecutive ICD implantation patients. Cardiac-troponin T (c-TNT) and heart-type fatty acid binding protein (H-FABP) levels were measured before implantation, 2 h after implantation, and 1 day after each DT. For an additional 122 patients with ICD, we retrospectively analyzed 203 DTs immediately and 7 days after device implantation. RESULTS: Serum c-TNT levels were significantly elevated 2 h after 15 J-DT [0.008 (0.004-0.019) vs. 0.053 (0.037-0.068) ng/mL, p<0.001], but not ≤10 J-DT [0.007 (0.004-0.018) ng/mL]. Similarly, serum H-FABP levels were significantly elevated 2 h after 15 J-DT (2.9±1.5 vs. 6.4±3.4 ng/mL, p<0.001), but not ≤10 J-DT (2.7±1.5 ng/mL). The changes in c-TNT and H-FABP levels between baseline and 2 h after DT were significantly greater for 15 J-DT compared with ≤10 J-DT [c-TnT: 0.039 (0.029-0.060) vs. 0 (0-0.003) ng/mL, p<0.001; H-FABP: 3.6±2.8 vs. -0.16±1.1 ng/mL, p<0.001]. The success rates of the initial shocks delivered for ventricular fibrillation were no different between ≤10 J-DT (85% [78/92]) and ≥15 J-DT (92% [103/111]). CONCLUSIONS: Elevated levels of myocardial damage markers such as c-TNT and H-FABP were not found after ≤10 J-DT. In addition, an acceptable success rate was confirmed in ≤10 J-DT.

Defibrillation Testing During Defibrillator Implantation.

Implantable cardioverter defibrillators (ICDs) terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) with high efficacy. ICDs improve mortality in patients after survived sudden cardiac death (SCD) and in patients at high risk of dying suddenly. All trials which show a benefit of ICD therapy, have performed some kind of defibrillation testing in order to prove correct system function, sensing of VF and effective defibrillation. Current devices show a shock efficacy of 80-90 % for singular shocks and devices provide up to seven rescue shocks. The probability that a device does not terminate an episode of VT or VF should therefore be very low. However, it is difficult to abandon defibrillation testing because prospective data is lacking that demonstrate non-inferiority, if ICDs are implanted without some kind of test. Two prospective trials are on the way and will be finish by 2013/14: the SIMPLE and NORDIC trial, which will answer the question if defibrillation testing can be abandoned without any effect on the benefit of ICD therapy or if testing may even be harmful.