The everolimus eluting Synergy MegatronTM drug-eluting stent platform: Early outcomes from the European Synergy MegatronTM Implanters' Registry.

BACKGROUND: The Synergy MegatronTM is an everolimus-drug eluting stent that may offer advantages in the treatment of aorto-ostial disease and large proximal vessels. AIMS: To report the short- to medium-term clinical outcomes from the European Synergy MegatronTM Implanters' Registry. METHODS: This registry was an investigator-initiated study conducted at 14 European centers. The primary outcome was target lesion failure (TLF), defined as the composite of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularisation. RESULTS: Five hundred seventy-five patients underwent PCI with MegatronTM between 2019 and 2021. Patients were 69 ± 12 years old, 26% had diabetes mellitus, 24% had moderate-severe left ventricular impairment and 59% presented with an acute coronary syndrome. 15% were deemed prohibitively high risk for surgical revascularisation. The target vessel involved the left main stem in 55%, the ostium of the RCA in 13% and was a true bifurcation (Medina 1,1,1) in 50%.  At 1 year, TLF was observed in 40 patients, with 26 (65%) occurring within the first 30 days. The cumulative incidence of TLF was 4.5% at 30 days and 8.6% (95% CI 6.3-11.7) at 1 year. The incidence of stent thrombosis was 0.5% with no late stent thromboses. By multivariate analysis, the strongest independent predictors of TLF were severe left ventricular impairment (HR 3.43, 95% CI: 1.67-6.76, p < 0.001) and a target vessel involving the left main (HR 4.00 95% CI 1.81-10.15 p = 0.001). CONCLUSIONS: Use of the Synergy MegatronTM everolimus eluting stent in a 'real-world' setting shows favorable outcomes at 30 days and 1 year.

Reframing Optimal Implantation of the Sapien 3 Transcatheter Heart Valve.

OBJECTIVES: To define the optimal implantation of the Sapien 3 (Edwards Lifesciences) transcatheter heart valve (THV), this study systematically analyzed the predeployment fluoroscopic THV position and correlated this to clinical outcomes. METHODS: This was an observational study of 279 patients treated with the Sapien 3 THV. Fluoroscopic imaging was used to categorize patients into low (n = 147), intermediate (n = 86), and high (n = 46) implantation zones. These zones were based on the relationship of the balloon marker and radiolucent line of the valve frame (line of lucency) to the annular plane at deployment. The primary outcome was the rate of permanent pacemaker implantation (PPI) at 30 days. The secondary outcomes were the rates of new left bundle-branch block (LBBB) in-hospital and all-cause mortality at 1 year. RESULTS: In the high, intermediate, and low groups, 30-day PPI rates were 4.3%, 8.1%, and 8.8% (P=.62); in-hospital LBBB rates were 10.9%, 26.7%, and 32.0% (P=.02); and all-cause mortality rates at 1 year were 3.1%, 7.3%, and 12.5% (P=.14), respectively. No differences were observed with respect to procedural success/complications or THV performance between the groups. CONCLUSION: This study demonstrates fewer conduction abnormalities for Sapien 3 valves positioned within a higher zone defined fluoroscopically by the line of lucency and balloon marker.

Initial Experiences of Percutaneous Coronary Intervention Using a New-Generation Everolimus-Eluting Stent Platform.

BACKGROUND: Outcomes from the new Synergy Megatron drug-eluting stent (DES) platform (Boston Scientific) are not yet reported. This study sought to evaluate periprocedural outcomes in patients undergoing percutaneous coronary intervention (PCI) using this technology. METHODS: This was a retrospective study across two United Kingdom centers of 139 patients undergoing PCI of 146 coronary lesions using the Synergy Megatron DES. The primary endpoint was the rate of cardiovascular death. The secondary endpoint was the rate of a composite of non-fatal myocardial infarction, target-vessel revascularization, in-stent restenosis, and probable/definite stent thrombosis. Available intravascular ultrasound (IVUS) imaging was reviewed post hoc and evaluated according to predefined IVUS optimization criteria. RESULTS: Mean follow-up duration was 137.3 ± 38.3 days. The primary endpoint occurred in 0.7% of patients and the secondary endpoint occurred in 0.0% of patients. There were no cases of longitudinal stent deformation (LSD); in patients undergoing an IVUS-guided procedure, our criteria for successful IVUS optimization was achieved in 74.1% of left main stem (LMS) and 83.3% of right coronary artery (RCA) lesions. Mean minimal stent area (MSA) was 14.5 ± 3.4 mm² in the LMS, 10.0 ± 2.5 mm² in the left anterior descending coronary artery, 9.8 ± 3.0 mm² in the left circumflex, and 12.2 ± 4.0 mm² in the RCA. CONCLUSION: This study demonstrated very low rates of short-term major adverse cardiovascular events with no cases of LSD or acute/subacute stent thrombosis. It highlights the overexpansion capabilities of the Synergy Megatron DES platform. The technology safely and effectively facilitates IVUS-optimized stent parameters for the treatment of large proximal vessels and bifurcations.