The model suggests that an S-ICD implantation strategy involving posterior generator location and coil and generator directly over the fascia without underlying fat is likely to markedly lower DFTs with the S-ICD and assist in troubleshooting of patients with unacceptably high DFTs.
Background:
The ability to predict defibrillation efficacy at the time of subcutaneous implantable cardioverter-defibrillator implantation without the need to induce ventricular fibrillation might eliminate the need for defibrillation testing. The purpose of this study was to determine the association of high-voltage impedance and system implant position on ventricular fibrillation conversion success with a submaximal 65-J shock.
Methods:
In the subcutaneous implantable cardioverter-defibrillator IDE study (Investigational Device Exemption), a successful conversion test required 2 consecutive ventricular fibrillation conversions at 65 J in either shock vector. Chest radiographs were obtained after implantation. Patients with imaging and impedance data were included. Suboptimal device position was defined as an inferior electrode or pulse generator or electrode coil depth >3 mm anterior to the sternum. Absence of suboptimal positional parameters was defined as appropriate position. Conversion success rate was calculated among all 65-J tests.
Results:
Of 314 patients who underwent subcutaneous implantable cardioverter-defibrillator implantation, 282 patients were included in this analysis. There were 637 inductions to test defibrillation at 65 J. Sixty-two conversion failures (9.7%) occurred in 42 (14.9%) patients. Lower body mass index and lower shock impedance were associated with higher conversion success rate, whereas white race was associated with lower conversion success rate. Suboptimal position was more common in obese patients. Inferior electrode and greater distance between the lead and sternum were associated with a higher impedance. When appropriate system position was achieved, conversion failure was not associated with high body mass index.
Conclusions:
Subcutaneous implantable cardioverter-defibrillator shock efficacy is associated with system position and high-voltage system impedance. A high impedance is associated with inferiorly placed pulse generator and electrode system, inadequate coil depth, and a lower rate of defibrillator success.
Clinical Trial Registration:
URL:
https://www.clinicaltrials.gov
. Unique identifier: NCT01064076.
Introduction: Transvenous implantable cardioverter-defibrillator (ICD) shocks have been associated with cardiac biomarker elevations and are thought in some cases to contribute to adverse clinical outcomes and mortality, possibly from myocardium exposed to excessive shock voltage gradients. Currently, there are only limited data for comparison with subcutaneous ICDs. We sought to compare ventricular myocardium voltage gradients resulting from transvenous (TV) and subcutaneous defibrillator (S-ICD) shocks to assess their risk of myocardial damage.Methods: A finite element model was derived from thoracic magnetic resonance imaging (MRI). Voltage gradients were modeled for an S-ICD with a left-sided parasternal coil and a left-sided TV-ICD with a mid-cavity, a septal right ventricle (RV) coil, or a dual coil lead (TV mid, TV septal, TV septal + superior vena cava [SVC]). High gradients were defined as > 100 V/cm.
Results:The volumes of ventricular myocardium with high gradients > 100 V/cm were 0.02, 2.4, 7.7, and 0 cc for TV mid, TV septal, TV septal + SVC, and S-ICD, respectively.
Conclusion:Our models suggest that S-ICD shocks produce more uniform gradients in the myocardium, with less exposure to potentially damaging electrical fields, compared to TV-ICDs. Dual coil TV leads yield higher gradients, as does closer proximity of the shock coil to the myocardium.
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