Clinical Evaluation of Defibrillation Testing in an Unselected Population of 2,120 Consecutive Patients Undergoing First Implantable Cardioverter-Defibrillator Implant

Brignole, Michele; Occhetta, Eraldo; Bongiorni, Maria Grazia; Proclemer, Alessandro; Favale, Stefano; Iacopino, Saverio; Calò, Leonardo; Vado, Antonello; Buja, Gianfranco; Mascioli, Giosuè; Quartieri, Fabio; Tritto, Massimo; Parravicini, Umberto; Castro, Antonio; Tomasi, Corrado; Villani, Giovanni; D'Acri, Matteo Giuseppe; Klersy, Catherine; Gasparini, Maurizio; Investigators, Safe-Icd Study

doi:10.1016/j.jacc.2012.05.014

Cited by 74 publications

(79 citation statements)

References 24 publications

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“…Our results are consistent with previous observational data [12][13][14][15][16][17][18][19][20][21][22] and meta-analyses [5,23] and provide further support to the recommendation to omit defibrillation efficacy testing in patients undergoing initial transvenous ICD implantation procedures [24]. Nonetheless, these results do not apply to specific subgroups, which were excluded or poorly represented in this meta-analysis, such as patients with right-sided ICD pocket or non-transvenous systems; patients with congenital heart diseases, channelopathies or hypertrophic cardiomyopathy; and patients who undergo device replacement.…”

Section: Strengths Of Our Analysissupporting

confidence: 94%

Updated Meta-Analysis of Randomized Trials Comparing Safety and Efficacy of Intraoperative Defibrillation Testing with No Defibrillation Testing On Implantable Cardioverter-Defibrillator Implantation

Bonanno

Rossillo

Paccanaro

et al. 2017

ijcp

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Introduction: There is an ongoing debate regarding the need to conduct intraoperative defibrillation testing (DFT) at the time of implantable cardioverter-defibrillator (ICD) implantation. To provide sufficiently strong evidence for the feasibility of omitting intraoperative DFT in clinical practice, we conducted a meta-analysis of randomized controlled trials (RCT) comparing patients with DFT and no-DFT. Methods: We systematically searched Medline (via PubMed), ClinicalTrial.gov, the Cochrane Central Register of Controlled Trials, and Embase for studies evaluating DFT vs. no-DFT on ICD implantation with regard to total mortality and arrhythmic death, efficacy of first and any appropriate shock in interrupting ventricular tachycardia (VT)/ ventricular fibrillation (VF), and procedural adverse events. Effect estimates [risk ratio (RR) with 95% confidence intervals (CI)] were pooled using the random-effects model. Results: Our meta-analysis included 4 RCTs comprising 3770 patients (1896 with DFT and 1874 without DFT). Total mortality (RR = 1.00, 95% CI 0.86-1.17; P = 0.98) and arrhythmic death (RR = 1.60, 95% CI 0.46-5.59: P = 0.46) were not statistically different. Both first (RR = 0.94, 95% CI 0.89-0.98; P = 0.004) and any appropriate ICD shock (RR = 0.97, 95% CI 0.95-1.00; P = 0.02) significantly increased the rate of VT/VF interruption in the group with no-DFT in comparison with DFT. Finally, the incidence of adverse events was lower in no-DFT patients (RR = 1.23; 95% CI 1.00-1.51; P = 0.05). Conclusions:The practice of DFT (as opposed to no-DFT) did not yield benefits in mortality or the overall rate of conversion of VT/VT. Moreover, a slightly higher incidence of perioperative adverse events was observed in the DFT group.

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Section: Strengths Of Our Analysissupporting

confidence: 94%

Updated Meta-Analysis of Randomized Trials Comparing Safety and Efficacy of Intraoperative Defibrillation Testing with No Defibrillation Testing On Implantable Cardioverter-Defibrillator Implantation

Bonanno

Rossillo

Paccanaro

et al. 2017

ijcp

View full text Add to dashboard Cite

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“…Unfortunately, the strength of these associations was weak, given the ORs were under 2 [223]. Other registries have identified patients with broader QRS durations, advanced NYHA class, and CRT as reasons for not performing DT [213]. There are no convincing data to identify highrisk patients, and clinical judgment has likely kept the highest-risk patients, particularly those who were hemodynamically unstable, from being tested in the current literature.…”

Section: Contraindications To Defibrillation Threshold Testingmentioning

confidence: 99%

“…There was, however, a nonsignificant increase in the risk of death or HF hospitalization in the group that underwent DT. Likewise, no significant difference in implantrelated complications was demonstrated in DT compared with the groups without DT in the Safety of Two Strategies of ICD Management at Implantation (SAFE-ICD) study, a prospective observational study of 2120 patients performed at 41 centers [213]. Similar findings were observed in the prospective randomized Test-No Test Implantable Cardioverter Defibrillator (TNT-ICD) pilot study on 66 patients, in which there was no difference in adverse events between patients who underwent testing compared with those who did not [214].…”

Section: Iia B-nrmentioning

confidence: 99%

2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing

et al. 2016

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“…[8][9][10][11] Induction of ventricular fibrillation (VF) during DFT can cause hemodynamic compromise, clinical deterioration, and life-threatening cerebrovascular accidents.…”

Section: Discussionmentioning

confidence: 99%

Assessment of Efficacy and Necessity of Routine Defibrillation Threshold Testing in Patients Undergoing Implantable Cardioverter-Defibrillator (ICD) Implantation

et al. 2015

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SummaryDefibrillation threshold (DFT) testing is performed routinely in patients undergoing implantable cardioverter-defibrillator (ICD) implantation to verify the ability of the ICD to terminate ventricular fibrillation (VF). However, neither the efficacy nor the safety of DFT testing has been proven; thus, the necessity of such testing is controversial. We conducted a retrospective study of the efficacy of DFT testing, particularly with respect to long-term outcomes of ICD implantation.The study included 150 patients (125 men, 25 women, aged 59.0 ± 17.6 years) who underwent ICD or cardiac resynchronization therapy defibrillator implantation, with (n = 73) or without (n = 77) intraoperative DFT testing, between June 1996 and September 2007. VF was induced by delivery of a T-wave shock, and a 20-25-J shock was then delivered. If the 20-25-J shock failed to terminate VF, 30 J was delivered. We assessed whether undersensed VF events occurred during DFT testing and/or during patient follow-up and checked for any association between undersensing and delayed shock delivery. During DFT testing, fine VF was sensed, and shocks were delivered in a timely manner. Nevertheless, 2 patients in the DFT testing group died from VF within 3 years after device implantation.DFT testing, in comparison to non-DFT testing, appeared to have no influence on the long-term outcomes of our patients, suggesting that DFT testing at the time of ICD implantation is limited. (Int Heart J 2015; 56: 618-621) Key words: Ventricular arrhythmia, Mortality I mplantable cardioverter-defibrillators (ICDs) have been shown to reduce mortality resulting from both ischemic 1,2) and non-ischemic cardiomyopathies 2) and to terminate potentially fatal ventricular arrhythmias.3,4) Current indications for an ICD include not only a near-fatal arrhythmic event 5) and ischemic cardiomyopathy but also severe nonischemic cardiomyopathy with a low left ventricular ejection fraction (LVEF).Defibrillation threshold (DFT) testing during ICD implantation has been considered necessary for appropriate shock delivery, 6) and a DFT safety margin of 10 J is the standard recommendation.6,7) However, neither the efficacy nor benefit of DFT testing has been proven. [8][9][10][11] Induction of ventricular fibrillation (VF) during DFT can cause hemodynamic compromise, clinical deterioration, and life-threatening cerebrovascular accidents.12-15) Thus, we conducted a retrospective study to assess the effect of DFT testing on long-term outcomes in patients with an ICD or cardiac resynchronization therapy defibrillator (CRT-D). MethodsStudy patients: The study included 150 patients (125 men, 25 women) who received an ICD (n = 85) or CRT-D (n = 65) at our hospital between June 1996 and September 2007. Hospital records were obtained, from which we extracted the patient clinical characteristics, follow-up times, ICD intracardiac recordings, and clinical outcomes. The ICDs and CRT-Ds were implanted in a standard transvenous manner. We divided the patients into 2 groups, those in whom DFT...

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Clinical Evaluation of Defibrillation Testing in an Unselected Population of 2,120 Consecutive Patients Undergoing First Implantable Cardioverter-Defibrillator Implant

Cited by 74 publications

References 24 publications

Updated Meta-Analysis of Randomized Trials Comparing Safety and Efficacy of Intraoperative Defibrillation Testing with No Defibrillation Testing On Implantable Cardioverter-Defibrillator Implantation

Updated Meta-Analysis of Randomized Trials Comparing Safety and Efficacy of Intraoperative Defibrillation Testing with No Defibrillation Testing On Implantable Cardioverter-Defibrillator Implantation

2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing

Assessment of Efficacy and Necessity of Routine Defibrillation Threshold Testing in Patients Undergoing Implantable Cardioverter-Defibrillator (ICD) Implantation

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