Comparison of percutaneous closure systems for large bore vascular access sites in endovascular procedures.

Backgrounds: The vascular closure device (VCD) is a medical device used for achieving hemostasis of vascular access sites greater than 8 Fr. We compared complications after placement of Perclose ProGlide (Abbott Vascular, USA), a percutaneous suture-mediated closure system, with MANTA VCD (Teleflex Vascular, USA), a collagen-based closure device. Methods: This retrospective cohort study analyzed procedures performed between 2016 and 2021. We compared the incidence of bleeding complications according to the Bleeding Academic Research Consortium (BARC) and Valve Academic Research Consortium-3 (VARC-3) criteria. The comparison was made between two cohorts of patients: in the first, vascular access sites were closed with a double Perclose ProGlide system, and in the second with an 18 Fr MANTA VCD. Results: A total of 189 patients were included in the study, out of which 63% were male and 37% were female, with a median age of 79 (72-83) years. All devices were used for femoral arterial access closure. A double Perclose ProGlide was used in 91 (48%) patients, while MANTA VCD was used in 98 patients (52%). The distribution of patients by VARC-3 and BARC bleeding criteria differs between groups (p = 0.017). A significantly higher incidence of VARC 1 (14% vs. 4%; p = 0.020) and BARC 1-2 (14% vs. 4%; p = 0.020) complications in the Perclose ProGlide cohort was observed. VARC 3 (1% vs. 5%; p = 0.213) and BARC 3b (1% vs. 5%; p = 0.213) complications showed higher, but statistically non-significant rates of major bleeding complications in the MANTA VCD cohort. The need for subsequent surgical revision did not show a significant difference between the cohorts (2% vs. 6%; p = 0.281). Conclusion: The Perclose ProGlide cohort was associated with a significantly higher rate of milder complications. MANTA VCD cohort had a higher rate of major bleeding complications, requiring more complex treatment with a potentially larger impact on quality of life.

Case Report: Optical Coherence Tomography Usage for Treatment of the Chronically Lost Stent in the Left Main Coronary Artery.

Acute adverse outcomes of a stent loss during percutaneous coronary intervention (PCI) are well described, however, data on long-term consequences are scarce, especially with intravascular imaging. We report a case of a coronary stent loss in the left main and ostial left circumflex artery (LCx) bifurcation and its migration into the LCx ostium during PCI procedures. This rare complication, which was not immediately noticed, was verified and successfully resolved 5 months after using optical coherence tomography and right trans-radial access. Considering the infrequency of this complication, few cases have been reported, however, our case has several distinct specificities. We aim to encourage the crushing technique in cases of chronic stent loss when the retrieval is not an option and highlight the optical coherence tomography (OCT) value in imaging and evaluation of similar complex settings.

Real-World Dual Antiplatelet Therapy Following Polymer-Free Sirolimus-Eluting Stent Implantations to Treat Coronary Artery Disease.

OBJECTIVES: The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population. METHODS: Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel. RESULTS: For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis. CONCLUSION: Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.

Drug-Coated Balloon Versus Drug-Eluting Stent in Primary Percutaneous Coronary Intervention: A Feasibility Study.

BACKGROUND: Drug-eluting stents (DES) represent a significant evolution in the treatment of patients with acute myocardial infarction with ST elevation. However, stent-related adverse events have led to an introduction of drug-coated balloons (DCB) applied particularly to bifurcation lesions, in-stent restenosis and small vessel disease. The aim of this study was to determine whether a DCB-only strategy has a similar safety profile and equal angiographic and clinical outcomes to DES implantation in primary percutaneous coronary intervention (pPCI). MATERIALS AND METHODS: Seventy-five patients with acute myocardial infarction with ST elevation were randomized into DES and DCB groups of 37 and 38 patients, respectively. The study end-points were major adverse cardiac events and late lumen loss during the 6 months following the pPCI. RESULTS: Reinfarction occurred in 5.4% of patients in the DES and 5.3% of patients in the DCB group after 1 month (risk ratio = 1.03, 95% CI [0.15-6.91], P = 0.98). After 6 months, major adverse cardiac events were reported in 5.4% of patients in the DES group and none in the DCB group (risk ratio = 5.13, 95% CI [0.25-103.42], P = 0.29). Late lumen loss in the DES group was 0.10 ± 0.19mm and -0.09 ± 0.09mm in the DCB group (P < 0.05). CONCLUSIONS: A DCB-only strategy is safe and feasible in the pPCI setting and showed good clinical and angiographic outcomes in a 6-month follow-up period.

Endovascular Management of Superior Mesenteric Artery (SMA) Aneurysm - Adequate Access is Essential for Success - Case Report.

BACKGROUND: An aneurysm of the superior mesenteric artery (SMA) with a diameter of 2.2 cm was found incidentally on an ultrasound (US) examination in a 26-year-old woman. The only known risk factor was an intracranial aneurysm that was found on her grandmother's autopsy. Based on pregnancy planning and the current literature, endovascular management with a covered stent was proposed. CASE REPORT: Self-expandable, covered stent (Bard, Fluency®) was implanted using a single transfemoral approach. A stiff guidewire and a large sheath distorted the anatomy, which resulted in an incomplete aneurysmal neck covering. In the absence of additional covered stents, the procedure was terminated. Two weeks later, computed tomographic angiography (CTA) confirmed persistent aneurysmal perfusion due to the incomplete neck coverage. A multidisciplinary board opted for a second endovascular attempt, this time with a longer covered stent via the transaxillary approach in order to reduce anatomical distortion. Balloon, expandable, cobalt-chrome covered stent (Jotec, E-ventus BX®) was implanted in the SMA, covering the aneurysmal neck and overlapping the previously implanted covered stent. Angiography confirmed a complete exclusion of the aneurysm. A control US performed three weeks later confirmed a patent covered stent and complete aneurysmal exclusion. There was a mild median nerve damage periprocedurally that resolved in three months. The most recent US control examination, performed eleven months after the procedure, showed an excluded aneurysm and a patent covered stent. There were no clinical signs of bowel ischaemia during the follow-up period. CONCLUSIONS: Endovascular management of SMAA proved to be safe and efficient. The "access from above" is probably safer and should be considered in the majority of cases with acceptable sizes of access vessels. Mid-term results in our patient are good and life-long follow-up is planned to prevent late complications.

Soluble adhesion molecules in patients with acute coronary syndrome after percutaneous coronary intervention with drug-coated balloon, drug-eluting stent or bare metal stent.

Adhesion molecules play an important role in inflammation, atherosclerosis and coronary artery disease (CAD). These molecules are expressed on the surface of dysfunctional endothelial cells, causing inflammatory cells from the circulation to adhere and migrate through the endothelium. Their expression is upregulated in acute coronary syndrome (ACS) and after percutaneous coronary intervention (PCI). The contact between stent struts and endothelium upregulates endothelial cell gene expression, endothelial cell activation and inflammation. The paclitaxel or sirolimus eluting stents inhibited expression of adhesion molecules in several studies and reduced the incidence of major adverse cardiac events (MACE) after drug-eluting stent (DES) over bare metal stent (BMS) implantation. Therefore, we propose that elevated serum levels of the soluble adhesion molecules after primary PCI in patients treated with BMS or DES implantation versus drug-coated balloon (DCB) application to the vulnerable coronary plaque might be a predictor of MACE and further adverse outcomes. Consequently, DCB-only strategy in patients with ACS might be a superior approach in comparison to BMS implantation and non-inferior approach when compared to DES implantation.

SEVEN-YEAR TRENDS IN THE CROATIAN PRIMARY PERCUTANEOUS CORONARY INTERVENTION NETWORK.

The authors investigated trends in the Croatian primary Percutaneous Coronary Intervention (pPCI) Network results among three consecutive time intervals (2005-2007, first phase; 2008-2009, second phase; and 2010-2011, third phase). Data on 5650 patients with acute myocardial infarction with ST-elevation (STEMI) transferred or directly admitted and treated with pPCI in 11 Croatian PCI centers during the study period were collected and analyzed. The number of patients with acute STEMI treated with pPCI per year rose continuously during the study period (581 vs. 1272 vs. 1949 patients/year). The patient risk profile worsened during the study period: age (60 vs. 61 vs. 63 years; p<0.01), anterior myocardial wall involvement (43% vs. 44% vs. 51%; p<0.01), shock rate (7% vs. 9% vs. 11%; p<0.05), and percentage of transferred patients (42% vs. 36% vs. 46%; p<0.01). While the door-to-balloon time shortened (108 vs. 98 vs. 75 min; p<0.01), the symptom onset-to-door time increased (130 vs. 175 vs. 195 min; p<0.01), but without statistically significant influence on the total ischemic time. Multivariate log-linear analysis eliminated influence of a higher risk profile on the results of treatment and yielded no statistically significant changes in final TIMI 3 flow (Thrombolysis In Myocardial Infarction 3), in-hospital mortality, and six-month mortality rate, but revealed a significant increase in the rate of angina pectoris (12 vs. 22 vs. 36%; p<0.01) and other major adverse cardiovascular events (MACE; 6 vs. 23 vs. 14%; p<0.01) during follow up. In conclusion, the Croatian pPCI Network continuously ensures very good results of STEMI treatment in this economically less developed European country despite worsening of the risk profile in treated patients and opening of new, less experienced PCI centers. The higher percentage of MACE over time could be explained by changes in the pPCI strategy introduced over time (the culprit lesion only) and higher availability of PCI centers for additional PCI after acute STEMI. However, there is room for improvement, especially in reducing prehospital delay.

Diagnostic accuracy of heart fatty acid binding protein (H-FABP) and glycogen phosphorylase isoenzyme BB (GPBB) in diagnosis of acute myocardial infarction in patients with acute coronary syndrome.

INTRODUCTION: This study aimed to assess whether heart fatty acid-binding protein (H-FABP) and glycogen phosphorylase isoenzyme BB (GPBB) could be used for the accurate diagnosis of acute myocardial infarction (AMI) in acute coronary syndrome (ACS) patients. MATERIALS AND METHODS: The study included 108 ACS patients admitted to a coronary unit within 3 h after chest pain onset. AMI was distinguished from unstable angina (UA) using a classical cardiac troponin I (cTnI) assay. H-FABP and GPBB were measured by ELISA on admission (0 h) and at 3, 6, 12, and 24 h after admission; their accuracy to diagnose AMI was assessed using statistical methods. RESULTS: From 92 patients with ACS; 71 had AMI. H-FABP and GPBB had higher peak value after 3 h from admission than cTnI (P = 0.001). Both markers normalized at 24 h. The area under the receiver operating characteristic curves was significantly greater for both markers in AMI patients than in UA patients at all time points tested, including admission (P < 0.001). At admission, the H-FABP (37%) and GPBB (40%) sensitivities were relatively low. They increased at 3 and 6 h after admission for both markers and decreased again after 24 h. It was 40% for H-FABP and approximately 2-times lower for GPBB (P < 0.01). In AMI patients, both biomarkers had similar specificities, positive- and negative-predictive values, positive and negative likelihood ratios, and risk ratios for AIM. CONCLUSION: H-FABP and GPBB can contribute to early AMI diagnosis and can distinguish AMI from UA.

Tako-tsubo syndrome in a 12-year-old girl: exhausted heart, not broken heart.

We report the case of a 12-year-old girl with Tako-tsubo cardiomyopathy. She was successfully treated in our Pediatric Intensive Care Unit for acute left ventricular failure, which occurred after a brief submersion in sea water. At 2-month follow-up she showed an almost complete recovery of cardiac function. We consider Tako-tsubo syndrome, which is rarely reported in the pediatric population, to be the most likely diagnosis.

Is mitral valve repair safe procedure in elderly patients?

The aim of this randomized, prospective, study was to evaluate postoperative hospital mortality and morbidity after mitral valve repair by comparing two surgical techniques for resolving mitral valve insufficiency in elderly patients. In comparison were: mitral valve repair vs. mitral valve replacement in patients older than 70 years. In period from January 1st 2006 until August 30th 2009. Eighty patients with mitral valve disease, isolated or associated with other comorbidities, were scheduled for mitral valve repair or mitral valve replacement in our institution. Patients were randomized in two groups, one scheduled for mitral valve repair and another one for mitral valve replacement using the envelope method with random numbers. Results show no difference in hospital mortality and morbidity postoperatively in both groups. In group undergoing valve replacement we had one significant complication of ventricle rupture in emphatically calcified posterior part of mitral valve annulus. In conclusion we found no distinction in postoperative hospital mortality and morbidity after using one of two surgical techniques.