Long-term outcomes of patients treated with sirolimus-eluting resorbable magnesium scaffolds: Insights from the SHERPA-MAGIC study

Background: The resorbable magnesium scaffold (RMS) is a second-generation bioresorbable scaffold (BRS) that has shown conflicting results in previous studies. These findings suggest that patient selection and implantation technique may have an impact on clinical outcomes. This study aimed to investigate the safety and long-term effectiveness of RMS in a narrowly selected population. Methods: SHERPA-MAGIC is an investigator-driven, multicenter, prospective, single-arm study that enrolled patients undergoing BRS coronary implantation in 18 Italian centers. The present analysis considered the first 543 enrolled patients treated with RMS, with a minimum follow-up of 1 year. The study protocol included strict criteria for patient selection and standardization of RMS implantation. The primary outcome was the occurrence of the vessel-oriented composite endpoints (VOCE), including cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. Results: Overall, 635 vessels were treated. The 1-year cumulative occurrence of VOCE was 22 (3.5%, 95% CI 2.2%-5.2%), which was significantly lower than the prespecified estimation (from 5.5% to 8.5%). At the median follow-up of 3.5 [2.6-4.3] years, there were 3 (0.5%) cardiac deaths, 12 (1.9%) target vessel myocardial infarctions, and 33 (5.2%) ischemia-driven target vessel revascularizations. A total of 37 (5.8%, 95%CI 4.1%- 7.9%) VOCEs were detected. Scaffold thrombosis occurred in 4 (0.6%, 95%CI 0.1%-1.6%) cases. Patient-level analysis confirmed the findings of the vessel-level analysis. Conclusions: These results confirm the safety and performance of RMS technology. If confirmed in randomized controlled trials, they may rekindle interest in the use of scaffolds in daily practice

Coronary Computed Tomography Angiography for the Assessment of Sirolimus-Eluting Resorbable Magnesium Scaffold

Background: Little evidence to date has described the feasibility and diagnostic accuracy of coronary computed tomography angiography (CCTA) with noninvasive fractional flow reserve (CT-FFR) in coronary vessels with resorbable magnesium scaffold (RMS). Methods: The SHERPA-MAGIC is a prospective study enrolling patients receiving RMS. The present analysis considered patients undergoing CCTA 18 months after the index procedure. CCTA images were employed to investigate reabsorption status, luminal measurements, and noninvasive FFR. Three-year follow-up was available for all patients. Results: Overall, 26 patients with a total of 29 coronary arteries treated with 35 RMS were considered. The most frequently involved vessel was left anterior descendent (LAD). Median stent length was 25 (20–25) mm, with a median diameter of 3 (3–3.5) mm. At 18-month CCTA, all scaffolded segments were patent. Complete RMS reabsorption was observed in 27 (93%, 95% CI 77–99%) cases. Median minimal lumen diameter (MLD) and area (MLA) of the scaffolded segments were 2.5 [2.1–2.8] mm and 6.4 [4.4–8.4] mm2, respectively. Median CT-FFR was 0.88 [0.81–0.91]. Only one (3.5%) vessel showed a flow-limiting CT-FFR value ≤0.80. During the 3-year follow-up, only one (4%) adverse event was observed. Conclusions: In patients undergoing RMS implantation, CCTA including noninvasive CT-FFR evaluation is feasible and allows investigation of long-term RMS performance

Device-related complications after Impella mechanical circulatory support implantation: an IMP-IT observational multicentre registry substudy

none25To report the incidence, the predictors and clinical impact of device-related complications (DRCs) in the IMP-IT (IMPella Mechanical Circulatory Support Device in Italy) registry. Impella is percutaneous left ventricular assist devices, which provides mechanical circulatory support both in cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI). The IMP-IT registry is a multicentre registry evaluating the trends in use and clinical outcomes of Impella in Italy.noneAncona, Marco B; Montorfano, Matteo; Masiero, Giulia; Burzotta, Francesco; Briguori, Carlo; Pagnesi, Matteo; Pazzanese, Vittorio; Trani, Carlo; Piva, Tommaso; De Marco, Federico; Di Biasi, Maurizio; Pagnotta, Paolo; Casu, Gavino; Garbo, Roberto; Preti, Gerlando; Nicolini, Elisa; Sclafani, Rocco; Colonna, Giuseppe; Mojoli, Marco; Siviglia, Massimo; Denurra, Cristiana; Caprioglio, Francesco; Scandroglio, Anna Mara; Tarantini, Giuseppe; Chieffo, AlaideAncona, Marco B; Montorfano, Matteo; Masiero, Giulia; Burzotta, Francesco; Briguori, Carlo; Pagnesi, Matteo; Pazzanese, Vittorio; Trani, Carlo; Piva, Tommaso; De Marco, Federico; Di Biasi, Maurizio; Pagnotta, Paolo; Casu, Gavino; Garbo, Roberto; Preti, Gerlando; Nicolini, Elisa; Sclafani, Rocco; Colonna, Giuseppe; Mojoli, Marco; Siviglia, Massimo; Denurra, Cristiana; Caprioglio, Francesco; Scandroglio, Anna Mara; Tarantini, Giuseppe; Chieffo, Alaid