Introduction Comparison data on management of device‐related complications and their impact on patient outcome and healthcare utilization between subcutaneous implantable cardioverter–defibrillator (S‐ICD) and transvenous ICD (TV‐ICD) are lacking. We designed this prospective, multicentre, observational registry to compare the rate, nature, and impact of long‐term device‐related complications requiring surgical revision on patient outcome and healthcare utilization between patients undergoing S‐ICD or TV‐ICD implantation. Methods and Results A total of 1099 consecutive patients who underwent S‐ICD or TV‐ICD implantation were enrolled. Propensity matching for baseline characteristics yielded 169 matched pairs. Rate, nature, management, and impact on patient outcome of device‐related complications were analyzed and compared between two groups. During a mean follow‐up of 30 months, device‐related complications requiring surgical revision were observed in 20 patients: 3 in S‐ICD group (1.8%) and 17 in TV‐ICD group (10.1%; p = .002). Compared with TV‐ICD patients, S‐ICD patients showed a significantly lower risk of lead‐related complications (0% vs. 5.9%; p = .002) and a similar risk of pocket‐related complications (0.6 vs. 2.4; p = .215) and device infection (0.6% vs. 1.2%; p = 1.000). Complications observed in S‐ICD patients resulted in a significantly lower number of complications‐related rehospitalizations (median 0 vs. 1; p = .013) and additional hospital treatment days (1.0 ± 1.0 vs. 6.5 ± 4.4 days; p = .048) compared with TV‐ICD patients. Conclusions Compared with TV‐ICD, S‐ICD is associated with a lower risk of complications, mainly due to a lower risk of lead‐related complications. The management of S‐ICD complications requires fewer and shorter rehospitalizations.

The recent introduction of new rules for the involvement of general practitioners in clinical trials in Italy, and the less recent decentralization process, have affected clinical investigations and regulatory activity. Regulatory affairs professionals and clinical researchers have had to become acquainted with a new, more dynamic, and more flexible environment for clinical trials that still guarantees high-quality protection to trial subjects. The regulatory environment for clinical trials in Italy has improved dramatically, supported by the authorities' continuous effort to improve the rules. Italy now attracts more innovative investigations. We summarize when, how, and where decentralized or centralized control of clinical trials is exerted, when general practitioners can be involved, and the role of the National Monitoring Centre for Clinical Trials in producing state-of-the-art on-line registers of clinical trial reports. We concluded that Italy has definitely left delays and bureaucracy behind, and is now ready to play a major role in clinical drug development and to provide an important contribution to innovative, original clinical investigations.