Cardiovascular Revascularization Medicine最新文献

Background: The Patient Experience in the Catheterization Laboratory (PATCATH) Questionnaire was developed by the European Association of Percutaneous Cardiovascular Intervention (EAPCI) to evaluate patient understanding of coronary catheterization procedures. In this study, we aimed to compare patient experience after coronary catheterization using the PATCATH questionnaire following provision of standard printed patient information leaflets (PILs) and PILs supplemented by specially developed video animations to aid informed consent.

Methods: The PATCATH questionnaire was administered anonymously to patients following coronary catheterization at a single tertiary referral center over two consecutive time periods. The questionnaire comprises 17 questions, divided into 3 domains, assessing patient experience before, during, and after the procedure. During phase 1, standard PILs were provided (PIL group). In phase 2, the PILs were supplemented with videos (PIL+ video group).

Results: The PATCATH tool was administered to a total of 296 patients following cardiac catheterization (22% female, 60.5% aged >65 years). 213 patients were included in the PIL group and 83 in the PIL + video group. Overall, positive patient satisfaction was reported in each domain. Positive patient satisfaction was comparable in both the PIL and the PIL+ video group in all 3 domains (before: 96.7% versus 100%, p = 0.20; during: 96.3% versus 97.3%, p > 0.99; after: 98.6% versus 97.6%, p = 0.62).

Conclusions: The use of a video animation in addition to a PIL when performing informed consent did not result in an increase in patient satisfaction as assessed by the PATCATH questionnaire.

Background: The Arrow® AC3™ Optimus™ Intra-Aortic Balloon Pump (IABP) is widely used for hemodynamic support in critically ill patients. Post-marketing surveillance data are essential to assess real-world safety and performance.

Methods: We conducted a systematic analysis of medical device reports related to the AC3™ Optimus™ IABP submitted to the FDA Manufacturer and User Facility Device Experience (MAUDE) database between 2017 and 2025. Events were categorized into types of adverse events, device problems, and patient problems. Frequencies and proportions were calculated.

Results: A total of 920 adverse events were identified. The majority were malfunctions (901, 97.9 %), followed by injuries (16, 1.7 %) and deaths (3, 0.3 %). Two of the reported deaths were reviewed in detail but were not clearly attributable to the device. Device problems (n = 1054) were most commonly related to the alarm system (146, 13.9 %), battery (126, 12.0 %), and gas/air leaks (101, 9.6 %). Other frequent issues included power problems (61, 5.8 %), connection problems (70, 6.6 %), and mechanical problems (53, 5.0 %). Patient problems were reported in 12 cases, with hypotension (2, 16.7 %), arrhythmia (1, 8.3 %), cardiac arrest (1, 8.3 %), hemorrhage (1, 8.3 %), and death (1, 8.3 %) among the documented outcomes. The majority of excluded patient problem reports (911, 98.7 %) lacked clinical details or showed no symptoms.

Conclusions: Most reported adverse events with the AC3™ Optimus™ IABP involved device malfunctions rather than direct patient injury or death. The most frequent device-related issues involved the alarm system, battery function, and gas/air leaks. While direct causality between device use and patient deaths was not established, vigilance in monitoring, device maintenance, and user training remains crucial to minimize risk.

Background: Hybrid drug-eluting stent/drug-coated balloon percutaneous coronary intervention (DES-DCB PCI) aims to minimize stent burden while maintaining patency in chronic total occlusion lesions.

Methods: We prospectively studied 19 consecutive CTO patients treated with a hybrid DES-DCB strategy; primary endpoint was late lumen loss (LLL) at 3-4 months, with secondary clinical outcomes at six months.

Results: Technical success was 89.5 %; mean LLL was 0.10 ± 0.83 mm; late lumen gain occurred in ~53 % of patients completing angiographic follow-up; binary restenosis was 10.5 %. Residual stenosis strongly predicted LLL, while optimal DCB sizing and inflation ≥180 s were protective; residual stenosis remained the independent predictor in multivariable regression. IVUS guidance was associated with 0 % restenosis.

Conclusions: Hybrid DES-DCB PCI for CTOs was feasible with low LLL. Outcomes hinged on lesion preparation, sizing, and inflation duration. The six-component GLOW score provides intra-procedural risk stratification and warrants multicenter validation.