Subcutaneous implantable devices safe for patients with congenital heart disease
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Key takeaways:
- Subcutaneous implantable cardioverter defibrillators can prevent arrhythmic death for people with congenital heart disease.
- Few people with congenital heart disease receive subcutaneous ICDs.
Subcutaneous implantable cardioverter defibrillators are effective in preventing arrhythmic death in people with congenital heart disease, with the devices successfully terminating all life-threatening ventricular arrhythmias, data show.
Although data show transvenous ICDs are highly effective in preventing arrhythmic death for high-risk patients, there is a considerable burden of long-term complications, Victor Waldmann, MD, PhD, a cardiac electrophysiologist with European Georges Pompidou Hospital, Paris, and colleagues wrote in the study background.
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Subcutaneous ICDs, introduced in France in 2012, are designed to reduce lead-related complications and risk for systemic infection or endocarditis.
“Subcutaneous ICD can be used to prevent arrhythmic death in high-risk patients with congenital heart disease, with an efficacy and a burden of complications similar to that observed in non-congenital patients,” Waldmann told Healio. “Long-term comparative data with transvenous ICD devices are needed to better assess the potential benefit/risk ratio improvement associated with subcutaneous ICD in this specific population.”
Study data
Waldmann and colleagues analyzed data from 101 patients with congenital heart disease across 150 centers who received a subcutaneous ICD, using data from the French Institute of Health and Medical Research (INSERM). Tetralogy of Fallot, univentricular heart and dextro-transposition of the great arteries represented nearly one-half of the population. Characteristics at implantation and outcomes were analyzed in patients with congenital heart disease.
The cohort represented just 2.1% of all patients in the registry who received a subcutaneous ICD, including nine children, according to researchers.
“In addition to data collection regarding medical history, indication of subcutaneous ICD, implantation procedure characteristics, arrhythmic events during follow-up, and complications associated with subcutaneous ICD, comprehensive information was recorded regarding the underlying type of congenital heart disease and the previous cardiac surgeries,” the researchers wrote. “Congenital heart diseases were classified according to the latest American Heart Association/American College of Cardiology and European Society of Cardiology classifications.”
Compared with patients without congenital heart disease, those with congenital heart disease were significantly younger (mean age, 37 years vs. 50 years; P < .001), more frequently women (37.6% vs. 23%; P < .001), more likely to receive a subcutaneous ICD for secondary prevention (72.3% vs. 35.9%; P < .001) and less likely to have severe systolic dysfunction of the systemic ventricle (28.1% vs. 53.1%; P < .001).
During a mean follow-up of 1.9 years, 15.8% of patients with congenital heart disease received at least one appropriate shock, with all shocks successfully terminating the ventricular arrhythmia.
The crude risk of appropriate subcutaneous ICD shock was twice as high among people with congenital heart disease compared with those without congenital heart disease, with annual incidences of 9% vs. 4.4% (HR = 2.1; 95% CI, 1.3-3.4); however, after propensity score matching, the association was no longer significant, according to the researchers.
The burden of all complications (HR = 1.2; 95% CI, 0.7-2.1; P = .4) and inappropriate shocks (HR = 0.9; 95% CI, 0.4-2; P = .9) was comparable in both groups.
“Subcutaneous ICDs are effective and safe in patients with congenital heart disease, and these patients experience twice as many appropriate shocks as non-congenital patients,” Waldmann told Healio.
Subcutaneous ICD ‘much-needed option’ for congenital heart disease
In a related editorial, Louise Harris, MBChB, of the division of cardiology at University Health Network Toronto General Hospital, and colleagues wrote that the study data — the largest analysis of a cohort of people with congenital heart disease receiving a subcutaneous ICD — have filled a knowledge gap. However, it is “debatable” whether these data are enough to consider subcutaneous ICD as the modality of choice for all people with congenital heart disease.
“The availability of subcutaneous ICD has provided a much-needed option,” Harris and colleagues wrote. “It is exciting to contemplate what developing technologies will offer. The combination of leadless pacing with subcutaneous ICD will add the possibility of bradycardia support and anti-tachycardia pacing, thus expanding the applicability of subcutaneous ICD. Newer algorithms to decrease inappropriate shocks and a reduction in generator size may also encourage more subcutaneous ICD use in complex congenital heart disease and smaller patients, respectively. Soon, skin deep might possibly cut it in congenital heart disease too.”
Reference:
For more information:
Victor Waldmann, MD, PhD, can be reached at victor.waldmann@gmail.com.
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