Medical simulation in interventional cardiology

Medical simulation is being used for training fellows to perform coronary angiography. Medical simulation training was associated with 2 min less fluoroscopy time per case after adjustment. Whether medical simulation really works needs to be evaluated in additional, well-designed and executed clinical studies

Role of Drug-coated Balloons in Small-vessel Coronary Artery Disease

Percutaneous coronary intervention of small-vessel coronary artery disease (SVD) remains challenging due to difficulties with device delivery and high restenosis rate, even with the use of newer-generation drug-eluting stents. Drug-coated balloons represent an attractive emerging percutaneous coronary intervention option in patients with SVD. Potential advantages of drug-coated balloons in SVD include enhanced deliverability because of their small profile, avoidance of foreign-body implantation, and shorter duration of dual antiplatelet therapy

Complications and failure modes of coronary embolic protection devices: Insights from the MAUDE database

BACKGROUND: There is limited data on complications associated with the use of coronary embolic protection devices (EPDs). METHODS: We queried the Manufacturer and User Facility Device Experience database between November 2010 and November 2020 for reports on coronary EPDs: Spider FX (Medtronic, Minneapolis, MN) and Filterwire EZ (Boston Scientific, Natick, MA). RESULTS: We retrieved 119 reports on coronary EPD failure (Spider FX n = 33 and Filterwire EZ n = 86), most of which (78.2%) occurred during saphenous vein graft interventions. The most common failure mode was inability to retrieve the EPD (49.6%), with the filter trapped against stent struts in 76.2% of the cases. Other device complications included filter fracture (28.6%), failure to cross (7.6%), failure to deploy (7.6%), and failure to recapture the filter (3.4%). Filter fracture (54.5 vs. 29.1%) and failure to recapture (9.1 vs. 2.1%) were more commonly reported, while failure to deploy the filter (0 vs. 10.5%) was less commonly reported with the Spider-FX. CONCLUSIONS: The most common modes of failure of coronary EPDs are the failure of retrieval (49.6%), followed by the filter fracture (28.6%). When using EPDs, careful attention to the technique is essential to avoid failures and subsequent complications

Comparative Analysis of Patient Characteristics in Cardiogenic Shock Studies: Differences Between Trials and Registries

OBJECTIVES: This study sought to evaluate the differences in cardiogenic shock patient characteristics in trial patients and real-life patients. BACKGROUND: Cardiogenic shock (CS) is a leading cause of mortality in patients presenting with acute myocardial infarction (AMI). However, the enrollment of patients into clinical trials is challenging and may not be representative of real-world patients. METHODS: We performed a systematic review of studies in patients presenting with AMI-related CS and compared patient characteristics of those enrolled into randomized controlled trials (RCTs) with those in registries. RESULTS: We included 14 RCTs (n = 2,154) and 12 registries (n = 133,617). RCTs included more men (73% vs 67.7%, P \u3c 0.001) compared with registries. Patients enrolled in RCTs had fewer comorbidities, including less hypertension (61.6% vs 65.9%, P \u3c 0.001), dyslipidemia (36.4% vs 53.6%, P \u3c 0.001), a history of stroke or transient ischemic attack (7.1% vs 10.7%, P \u3c 0.001), and prior coronary artery bypass graft surgery (5.4% vs 7.5%, P \u3c 0.001). Patients enrolled in RCTs also had lower lactate levels (4.7 ± 2.3 mmol/L vs 5.9 ± 1.9 mmol/L, P \u3c 0.001) and higher mean arterial pressure (73.0 ± 8.8 mm Hg vs 62.5 ± 12.2 mm Hg, P \u3c 0.001). Percutaneous coronary intervention (97.5% vs 58.4%, P \u3c 0.001) and extracorporeal membrane oxygenation (11.6% vs 3.4%, P \u3c 0.001) were used more often in RCTs. The in-hospital mortality (23.9% vs 38.4%, P \u3c 0.001) and 30-day mortality (39.9% vs 45.9%, P \u3c 0.001) were lower in RCT patients. CONCLUSIONS: RCTs in AMI-related CS tend to enroll fewer women and lower-risk patients compared with registries. Patients enrolled in RCTs are more likely to receive aggressive treatment with percutaneous coronary intervention and extracorporeal membrane oxygenation and have lower in-hospital and 30-day mortality

Laser for balloon uncrossable and undilatable chronic total occlusion interventions

BACKGROUND: There is limited information on use of laser in complex percutaneous coronary interventions (PCI). We examined the impact of laser on the outcomes of balloon uncrossable and balloon undilatable chronic total occlusion (CTO) PCI. METHODS: We reviewed baseline clinical and angiographic characteristics and procedural outcomes of 4845 CTO PCIs performed between 2012 and 2020 at 32 centers. RESULTS: Of the 4845 CTO lesions, 752 (15.5%) were balloon uncrossable (523 cases) or balloon undilatable (356 cases) and were included in this analysis. Mean patient age was 66.9 ± 10 years and 83% were men. Laser was used in 20.3% of the lesions. Compared with cases in which laser was not used, laser was more commonly used in longer length occlusions (33 [21, 50] vs. 25 [15, 40] mm, p = 0.0004) and in-stent restenotic lesions (41% vs. 20%, p \u3c 0.0001). Laser use was associated with higher technical (91.5% vs. 83.1%, p = 0.010) and procedural (88.9% vs. 81.6%, p = 0.033) success rates and similar incidence of major adverse cardiac events (3.92% vs. 3.51%, p = 0.805). Laser use was associated with longer procedural (169 [109, 231] vs. 130 [87, 199], p \u3c 0.0001) and fluoroscopy time (64 [40, 94] vs. 50 [31, 81], p = 0.003). CONCLUSIONS: In a contemporary, multicenter registry balloon uncrossable and balloon undilatable lesions represented 15.5% of all CTO PCIs. Laser was used in approximately one-fifth of these cases and was associated with high technical and procedural success and similar major complication rates