Major Complications and Failure Modes of the Angiosculpt Scoring Balloon Catheter: Analysis of the MAUDE Database.

Since its Food and Drug Administration approval in January 2007, the Angiosculpt scoring balloon catheter has been widely utilized in severely calcified stenotic vascular lesions. We sought to characterize the complication rates, failure modes, and outcomes associated with the Angiosculpt catheter. Using queried events from October 2013 to December 2020 from the Food and Drug Administration Manufacturer and User Facility Device Experience database, we analyzed the Angiosculpt scoring balloon catheter complication rates and mode of failure. A total of 248 complications were reported. Most reported complications occurred in the superficial femoral artery (SFA) (19.4%, n = 48), followed by the left anterior descending artery (8.1%, n = 20). Severe vessel calcifications were reported in (26.6%, n = 66) of the complications. Most complications occurred with damage to the device, such as tip break (44.8%, n = 111) and balloon rupture (26.6%, n = 66). Some complications were due to difficulties in the withdrawal of the catheter (23.8%, n = 59). Balloon rupture is observed at a significantly higher rate amongst calcified vessels (60.6% vs 14.8%), P = < 0.001, and in cases involving the SFA (39.4% vs 11.3%), P = < 0.001. All-cause complications in calcified vessels are associated with the SFA (39.4% vs 12.5%), P = < 0.001, and left anterior descending artery (16.7% vs 5.1%), P = < 0.001. The Angiosculpt scoring balloon catheter has a relatively low complication rate. Most complications were associated with a device tip break, balloon rupture, and difficulties in withdrawal in severely calcified vessels.

Outcomes of beta blocker use in cocaine-associated chest pain: a meta-analysis.

OBJECTIVES: Beta blockers (ß-blockers) remain a standard therapy in the early treatment of acute coronary syndromes. However, ß-blocker therapy in patients with cocaine-associated chest pain (CACP) continues to be an area of debate due to the potential risk of unopposed α-adrenergic stimulation and coronary vasospasm. Therefore, we performed a systematic review and meta-analysis of available studies to compare outcomes of ß-blocker versus no ß-blocker use among patients with CACP. METHODS: We searched the MEDLINE and EMBASE databases through September 2016 using the keywords 'beta blocker', 'cocaine' and commonly used ß-blockers ('atenolol', 'bisoprolol', 'carvedilol', 'esmolol', 'metoprolol' and 'propranolol') to identify studies evaluating ß-blocker use among patients with CACP. We specifically focused on studies comparing outcomes between ß-blocker versus no ß-blocker usage in patients with CACP. Studies without a comparison between ß-blocker and no ß-blocker use were excluded. Outcomes of interest included non-fatal myocardial infarction (MI) and all-cause mortality. Quantitative data synthesis was performed using a random-effects model and heterogeneity was assessed using Q and I2statistics. RESULTS: A total of five studies evaluating 1794 subjects were included. Overall, there was no significant difference on MI in patients with CACP on ß-blocker versus no ß-blocker (OR 1.36, 95% CI 0.68 to 2.75; p=0.39). Similarly, there was no significant difference in all-cause mortality in patients on ß-blocker versus no ß-blocker (OR 0.68, 95% CI 0.26 to 1.79; p=0.43). CONCLUSIONS: In patients presenting with acute chest pain and underlying cocaine, ß-blocker use does not appear to be associated with an increased risk of MI or all-cause mortality.