Cardiovascular Revascularization Medicine最新文献

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.

Background: Recently, angiography-derived index of microvascular resistance (angio-IMR) has emerged as a less invasive alternative to estimate CMD during cardiac catheterization. Whether CMD differs across vessel territories and populations remains disputed.

Methods: Consecutive all-comer patients undergoing coronary angiography for chronic coronary syndrome (CCS) or non-ST-elevation myocardial infarction (NSTEMI) enrolled in the PIONEER-IV trial at the University Medical Center Groningen were included. Angio-IMR was retrospectively calculated using quantitative flow ratio (QFR) software in all three major coronary vessel territories pre- and post-PCI, if applicable. Angio-IMR levels were compared between coronary vessels, indication, and sex. The association between angio-IMR and LV function on AI-derived echocardiography analyses were assessed.

Results: In 220 patients, mean age was 65 ± 9 years, 18.3 % were women, and 20.3 % presented with NSTEMI. CMD was common: 80.0 % had baseline angio-IMR ≥25 mmHg·s/cm. Angio-IMR was similar in the LAD, RCA and LCX in both target and non-target vessels (p > 0.05). In the LAD, angio-IMR increased significantly post-PCI (p < 0.001), while RCA and LCX showed no significant change. Whilst NSTEMI patients showed similar baseline angio-IMR as CCS patients, they had lower post-PCI angio-IMR (p = 0.011). Women had lower average post-PCI angio-IMR (27 vs. 37 mmHg·s/cm, p < 0.001) and showed improved microvascular resistance post-PCI. Angio-IMR was not associated with cardiac function overall, but in NSTEMI patients, higher baseline angio-IMR correlated with worse LV function.

Conclusion: Angio-IMR is similar in all coronary vessels, but lower in NSTEMI patients than in CCS and lower in women. In NSTEMI patients, higher IMR was associated with worse LV function.

Background: Approximately one-tenth of patients undergoing percutaneous coronary intervention (PCI) of a chronic total occlusion(CTO) have chronic kidney disease (CKD). There are limited data on outcomes in patients with CKD undergoing elective CTO PCI and our aim was to investigate the short-term outcomes of these patients.

Methods: We utilized Nationwide Inpatient Sample (NIS) database (years 2010-11) to identify all hospitalizations associated with elective single-vessel CTO PCI. Afterwards, patients were categorized into two groups according to CKD status, with the CKD group further stratified by stage. Primary outcome was in-hospital mortality and secondary outcomes were periprocedural complications. We also investigated the length of hospital stay and costs. Discharge weights were used to produce national estimates.

Results: We identified 6164 adult patients who underwent single-vessel CTO PCI. There were 604 patients (9.85 %) with CKD. They were older, with higher prevalence of hypertension, diabetes mellitus, atrial fibrillation, peripheral artery disease and chronic obstructive pulmonary disease. CKD was independently associated with higher in-hospital mortality, demonstrating a 74 % increase in odds per category (non-CKD, moderate-severe CKD (encompassing CKD stage 3-5) and end-stage renal disease requiring chronic dialysis). Patients with CKD had significantly higher rates of periprocedural myocardial infarction, acute kidney injury (AKI) and need for initiation of dialysis, as well as composite outcome of periprocedural complications. Consequently, this resulted in longer hospital stay and higher hospitalization costs.

Conclusion: CKD is independently associated with higher in-hospital mortality among patients undergoing elective single-vessel CTO PCI, demonstrating increasing odds with worsening CKD. Presence of CKD is associated with a higher rate of periprocedural complications, prolonged hospital stay and increased hospitalization costs.

Background: Routine manual aspiration thrombectomy has shown limited benefit in patients with acute coronary syndrome (ACS). Selective application of mechanical thrombectomy in patients with ACS and high thrombus burden may improve coronary flow and myocardial perfusion. We aimed to compare safety and efficacy between manual (MaT) and mechanical aspiration thrombectomy (MeT) in this population.

Methods: Retrospective review of 70 patients presenting with ACS between May 2019 and February 2024, with 27 receiving MaT and 43 MeT. Our comparative analysis included Thrombolysis in Myocardial Infarction (TIMI) thrombus grade, TIMI flow grade, Myocardial Blush grade, survival to discharge and stroke.

Results: There was no difference in the clinical characteristics of the two groups except higher prevalence of hypertension in the MaT group (93 % vs 70 % in MeT, p = 0.02). Baseline thrombus burden did not differ between groups. Both MaT and MeT resulted in a significant reduction in thrombus burden and improvement in coronary flow and myocardial blush. MaT and MeT had similar post-thrombectomy rates of TIMI thrombus grade 0 (63 % vs 77 %, p = 0.3), TIMI flow grade 3 (70 % vs 67 %, p = 1) and Myocardial Blush grade 3 (44 % vs 51 %, p = 0.6). One stroke was reported in the MeT group. Finally, Survival to discharge was similar (MaT 88 % vs MeT 84 %, p = 0.7).

Conclusions: Selective thrombectomy in ACS patients with high thrombus burden is safe and effectively reduces thrombus burden while improving coronary flow and myocardial perfusion. Manual and mechanical thrombectomy show similar efficacy and safety profiles.

Background: Fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFR_CT) facilitates virtual PCI planning and informs stent length selection based on predicted post-PCI FFR_CT. This approach was previously validated against pressure-wire based FFR. Whether angiographic FFR can be used to ascertain the target post-PCI FFR_CT predicted from CCTA is uncertain.

Methods: Observational cohort study of patients undergoing coronary computed tomography angiography (CCTA) with an FFR_CT ≤ 0.80 that were referred to CCTA-guided PCI using the FFR_CT-based virtual planner (HeartFlow Inc.) for pre-procedural guidance and FFR_angio (CathWorks Ltd.) for intra- and post-procedural assessment. Virtual FFR pullbacks (FFR measurements every 1 mm across the vessel length) were analyzed and compared for both FFR_CT and FFR_angio modalities. We evaluated the agreement between pre- and post-PCI FFR_CT and FFR_angio at matched locations using the Pearson correlation coefficient and Bland-Altman analysis. Virtual FFR pullbacks (FFR measurements every 1 mm across the vessel length) were analyzed and compared for both FFR_CT and FFR_angio modalities.

Results: A total of 2290 post-PCI FFR values were derived from 20 vessels that underwent CCTA-guided PCI virtual PCI followed by post-PCI FFR_angio. FFR values were matched across FFR pullback tracings that allowed the comparison of predicted post-PCI FFR_CT to observed post PCI FFR_angio results. The left anterior descending artery (LAD) (45 %) was the most common target vessel. A strong correlation was observed between FFR_CT and FFR_angio (R = 0.74; p < 0.001). The mean difference at matched locations was -0. 01 FFR units, with a standard deviation of 0.04 and limits of agreement ranging from -0.10 to 0.07.

Conclusion: Predicted post-PCI FFR_CT values derived from CCTA-based virtual PCI have an excellent correlation with observed post-PCI FFRangio values derived from invasive coronary angiography after stenting. These findings highlight the novel concept of wireless end-to-end physiology guided PCI, integrating pre-PCI FFR_CT and post-PCI angiographic FFR as complementary tools.

Background and aims: Suture-based vascular closure devices (S-VCD) plus the liberal use of an additional small plug-based VCD have been demonstrated to be superior to "pure" plug-based VCD (P-VCD) in patients treated with transcatheter aortic valve implantation (TAVI). Preliminary data suggests that the systematic use of the arteriotomy-site ballooning plus concomitant manual compression following P-VCD (MANTA, Teleflex) delivery may optimize the device apposition and should be adopted to improve the final hemostatic efficacy.

Methods: Consecutive patients undergoing transfemoral TAVI at two Italian centers between were included. Patients treated with S-VCD and balloon assisted P-VCD were matched for major variables. The primary outcome was the occurrence of any in-hospital vascular complication. All outcomes were defined according to the Valve Academic Research Consortium (VARC)-3 statement.

Results: Overall, 799 patients were included (S-VCD: 451; balloon-assisted P-VCD: 348). Patients in the S-VCD group received 2 ProGlides (Abbott Vascular Inc.) plus the liberal use of an additional small plug-based VCD. Patients in the P-VCD group received the systematic use of the arteriotomy-site ballooning plus concomitant manual compression. After matching, 123 pairs of subjects were selected. The primary outcome occurred in 11.4 % of patients in the S-VCD group and 6.5 % in the balloon assisted P-VCD group (OR 0.56, 95 % CI (0.22-1.40); p = 0.217). Major VARC-3 vascular complications were more frequent in the S-VCD cohort (OR 0.12, 95 % CI (0.01-0.96); p = 0.048). No differences were found for the composite of major vascular complications and in-hospital death (OR 0.59, 95 % CI (0.19-1.88); p = 0.377). Any VARC-3 access related bleedings were slightly more frequent in the S-VCD group (OR 0.27, 95 % CI (0.07-0.99); p = 0.048), while no differences were evident for major bleedings (OR 0.28, 95 % CI (0.06-1.40); p = 0.122).

Conclusions: The balloon-assisted P-VCD showed similar vascular outcomes compared to traditional S-VCD in patients undergoing transfemoral TAVI.