Olde Nordkamp Louise R A, Pepplinkhuizen Shari, Ghani Abdul, Boersma Lucas V A, Kuschyk Juergen, El-Chami Mikhael F, Behr Elijah R, Brouwer Tom F, Kääb Stefan, Mittal Suneet, Quast Anne-Floor B E, van der Stuijt Willeke, Smeding Lonneke, de Veld Jolien A, Tijssen Jan G P, Bijsterveld Nick R, Richter Sergio, Brouwer Marc A, de Groot Joris R, Kooiman Kirsten M, Lambiase Pier D, Neuzil Petr, Vernooy Kevin, Alings Marco, Betts Timothy R, Bracke Frank A L E, Burke Martin C, de Jong Jonas S S G, Wright David J, Jansen Ward P J, Whinnett Zachary I, Nordbeck Peter, Knaut Michael, Philbert Berit T, van Opstal Jurren M, Chicos Alexandru B, Allaart Cornelis P, Borger van der Burg Alida E, Dizon Jose M, Miller Marc A, Nemirovsky Dmitry, Surber Ralf, Upadhyay Gaurav A, Weiss Raul, de Weger Anouk, Wilde Arthur A M, Knops Reinoud E
Department of Cardiology, Amsterdam UMC Location University of Amsterdam, Heart Center, Amsterdam Cardiovascular Sciences Heart failure and Arrhythmias, the Netherlands (L.R.A.O.N., S.P., L.V.A.B., T.F.B., A.-F.B.E.Q., W.v.d.S., L.S., J.A.d.V., J.G.P.T., N.R.B., J.R.d.G., K.M.K., A.d.W., A.A.M.W., R.E.K.).
Department of Cardiology, Isala Heart Centre, Zwolle, the Netherlands (A.G.).
Circ Arrhythm Electrophysiol. 2024 Dec;17(12):e012836. doi: 10.1161/CIRCEP.124.012836. Epub 2024 Dec 3.
Inappropriate therapy (IAT) is an undesirable side effect of implantable cardiac defibrillator (ICD) therapy. Early studies with the subcutaneous ICD (S-ICD) showed relatively high inappropriate shock (IAS) rates. The PRAETORIAN (Prospective Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) trial demonstrated that the S-ICD is noninferior to the transvenous ICD (TV-ICD) with regard to the combined end point of IAS and complications. This secondary analyses evaluates all IAT in the PRAETORIAN trial.
This international, multicenter trial randomized 849 patients with an indication for ICD therapy between S-ICD (n=426) and TV-ICD therapy (n=423). ICD programming was mandated by protocol. All analysis were performed in the modified intention-to-treat population.
In both groups 42 patients experienced IAT (48-month Kaplan-Meier estimated cumulative incidence, 9.9% and 10.1%, respectively; hazard ratio (HR), 0.99 [95% CI, 0.65-1.52]; =0.97). There was no significant difference in patients experiencing IAS between both groups (=0.14). In the S-ICD group, 81 IAT episodes with 124 IAS and 1 inappropriate antitachycardia pacing occurred versus 89 IAT episodes with 130 IAS and 124 inappropriate antitachycardia pacing in the TV-ICD group. IAT episodes were most frequently caused by supraventricular tachycardias in the TV-ICD group (n=83/89) versus cardiac oversensing in the S-ICD group (n=40/81). In the TV-ICD group, a baseline heart rate >80 bpm (HR, 1.99 [95% CI, 1.05-3.76]; =0.03), a history of atrial fibrillation (HR, 2.66 [95% CI, 1.41-5.02]; =0.003), and smoking (HR, 2.46 [95% CI, 1.31-4.09]; =0.005) were independent predictors for IAT. A QRS duration >120 ms was an independent predictor for IAT caused by cardiac oversensing in the S-ICD group (HR, 3.13 [95% CI, 1.34-7.31]; =0.008). Post-IAS interventions significantly reduced IAS recurrence in both groups (=0.046).
There was no significant difference in IAT and IAS rates between the S-ICD and TV-ICD in a conventional ICD population, but causes and predictors for IAT differed between the devices. After the first IAS, an intervention significantly reduced the recurrence rate of IAS.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.
不适当治疗（IAT）是植入式心脏除颤器（ICD）治疗的不良副作用。早期皮下ICD（S-ICD）研究显示不适当电击（IAS）发生率相对较高。PRAETORIAN（皮下与经静脉植入式心脏复律除颤器治疗的前瞻性随机比较）试验表明，在IAS和并发症的联合终点方面，S-ICD不劣于经静脉ICD（TV-ICD）。本二次分析评估了PRAETORIAN试验中的所有IAT。
这项国际多中心试验将849例有ICD治疗指征的患者随机分为S-ICD组（n = 426）和TV-ICD治疗组（n = 423）。ICD程控由方案规定。所有分析均在改良意向性治疗人群中进行。
两组均有42例患者发生IAT（48个月Kaplan-Meier估计累积发生率分别为9.9%和10.1%；风险比（HR）为0.99[95%CI，0.65 - 1.52]；P = 0.97）。两组间发生IAS的患者无显著差异（P = 0.14）。S-ICD组发生81次IAT事件，其中124次IAS和1次不适当抗心动过速起搏，而TV-ICD组发生89次IAT事件，其中130次IAS和124次不适当抗心动过速起搏。TV-ICD组IAT事件最常见的原因是室上性心动过速（n = 83/89），而S-ICD组是心脏感知过度（n = 40/81）。在TV-ICD组，基线心率>80次/分（HR，1.99[95%CI，1.05 - 3.76]；P = 0.03）、房颤病史（HR，2.66[95%CI，1.41 - 5.02]；P = 0.003）和吸烟（HR，2.46[95%CI，1.31 - 4.09]；P = 0.005）是IAT的独立预测因素。QRS时限>120 ms是S-ICD组心脏感知过度所致IAT的独立预测因素（HR，3.13[95%CI，1.34 - 7.31]；P = 0.008）。首次IAS后的干预显著降低了两组的IAS复发率（P = 0.046）。
在常规ICD人群中，S-ICD和TV-ICD的IAT和IAS发生率无显著差异，但两种装置的IAT原因和预测因素有所不同。首次IAS后，干预显著降低了IAS的复发率。
