Browsing by Author "Mehmedbegovic, Zlatko (55778381000)"

In patients presenting with acute coronary syndrome without ST elevation, both FFR and OCT imaging may be necessary to adequately interrogate patients with intermediate and ambiguous left-main coronary stenosis. © 2020 The Authors. Clinical Case Reports published by John Wiley & Sons Ltd.

Aims: To report the six-month angiographic and two-year clinical outcome data from the first-in-man study with the Ultimaster DES, a thin-strut cobalt-chromium sirolimus-eluting stent (SES) with an innovative abluminal-gradient-coated bioresorbable polymer. Methods and results: CENTURY is a multicentre, single-arm, prospective study that enrolled 105 patients (113 lesions) with coronary artery disease. All patients were scheduled to have an angiographic follow-up at six months, while 45 and 20 patients respectively had IVUS and OCT assessments. The primary endpoint was six-month in-stent late lumen loss. Secondary endpoints included clinical, IVUS and OCT outcomes. Clinical follow-up is available up to two years and will continue up to five years. Procedural success was 97.1% and device success was 100%. Angiographic late loss at six months was 0.04±0.35 mm, also reflected in a low binary restenosis rate of 0.9% and confirmed by IVUS-assessed neointimal volume obstruction of 1.02±1.62%. The mean strut coverage assessed by OCT was 96.2% with 1.66±4.02 malapposed stent struts. There were no deaths in the study, three (2.9%) periprocedural and one (0.9%) spontaneous myocardial infarction, not related to the target vessel. At one and two years, the target lesion failure rate was 3.8% and 5.7%, while the TLR rate was 1.9% and 2.8%, respectively. There was one acute definite stent thrombosis. Conclusions: The Ultimaster™ novel bioresorbable polymer sirolimus-eluting stent demonstrated good performance, including high procedural success and strong suppression of neointimal proliferation at six months. Good safety and effectiveness were shown up to two years in the studied population. © Europa Digital & Publishing 2015. All rights reserved.

Objectives To evaluate the safety and effectiveness of the Kaname™ cobalt-chromium (Co-Cr), thin strut, bare metal stent (BMS) system for the treatment of coronary artery lesions.; Background Despite widespread use of drug-eluting stents, a certain percentage of patients with coronary artery disease are still treated with BMS. Therefore, it is essential to evaluate their clinical performance.; Methods Two hundred eighty-two patients were enrolled in this prospective, single-arm study including a predefined subset of 79 patients with small vessels. The primary end-point was freedom from target vessel failure (TVF) at 6 months. Key angiographic and intravascular ultrasound (IVUS) end-points were late loss, diameter stenosis, binary restenosis, and neointimal hyperplasia volume.; Results Freedom from TVF at 6 months was 93.3% and at 1 year 90.8% in total population, and 92.4% and 87.3% in small vessels, respectively. Clinically driven target lesion revascularization (TLR) rates at 6 and 12 months were 4.3% and 6.4% in total population, and 3.8% and 7.6% in small vessels, respectively. At 6 months in-stent late loss was 0.75 plusmn; 0.43 mm and binary restenosis rate was 16.9% in total population, and 0.64 plusmn; 0.40 mm and 26.1% in small vessels, while IVUS assessed neointimal hyperplasia volume at 6 months was 128.9 plusmn; 42.6 mm3 for total population. There were no definite and probable stent thromboses up to 12 months.; Conclusions Results indicate good safety and effectiveness of the Kaname™ stent with clinically equivalent results in small and larger vessels, as such providing useful treatment option for patients with ischemic heart disease considered for BMS implantation. (J Interven Cardiol 2014;27:491-499) © 2014, Wiley Periodicals, Inc.

Background: Coronary microvascular dysfunction is associated with adverse prognosis after ST-segment elevation myocardial infarction (STEMI). We aimed to compare the invasive, Doppler wire-based coronary flow reserve (CFR) with the non-invasive transthoracic Doppler echocardiography (TTDE)-derived CFR, and their ability to predict infarct size. Methods: We included 36 patients with invasive Doppler wire assessment on days 3–7 after STEMI treated with primary percutaneous coronary intervention (PCI), of which TTDE-derived CFR was measured in 47 vessels (29 patients) within 6 h of the invasive Doppler. Infarct size was assessed by cardiac magnetic resonance at a median of 8 months. Results: The correlation between invasive and non-invasive CFR was modest in the overall cohort (rho 0.400, p = 0.005). It improved when only measurements in the LAD artery were considered (rho 0.554, p = 0.002), with no significant correlation in the RCA artery (rho −0.190, p = 0.435). Both invasive (AUC 0.888) and non-invasive (AUC 0.868) CFR, measured in the recanalized culprit artery, showed a good ability to predict infarct sizes ≥18% of the left ventricular mass, with the optimal cut off values of 1.85 and 1.80, respectively. Conclusions: In patients with STEMI, TTDE- and Doppler wire-derived CFR exhibit significant correlation, when measured in the LAD artery, and both have a similarly strong association with the final infarct size. © 2024 by the authors.

Background: Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months. Methods: We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed. Findings: Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91–1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed. Interpretation: Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI. Funding: British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden. © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license

The objective of the study was to evaluate major adverse cardiovascular events (MACE) after successful versus failed percutaneous coronary intervention for chronic total occlusion (PCI-CTO). Limited data are available on long-term clinical follow-up in the treatment of chronic total occlusion (CTO). Between January 2009 and December 2010 PCI-CTO was attempted in 283 consecutive patients with 289 CTO lesions. Procedural success was 62.3% and clinical follow-up covered 83% (235/283) of the study population with a median follow-up of 66 months (range, 59-74). The total incidence of MACE was 57/235 (24.3%), and was significantly higher in the procedural failure group than in the procedural success group (33/87 (37.9%) versus 24/148 (16.2%), P < 0.001). All-cause mortality was significantly lower in patients with successful PCI-CTO compared to failed PCI-CTO (10.8% versus 20.7%, P < 0.05). Also, the rate of cardiovascular death in the procedural failure group (14.9%) was slightly higher than that in the procedural success group (7.4%, P = 0.066). The rate of TVR was statistically higher in the procedural failure group (P < 0.009). Propensity score-adjusted Cox regression showed that procedural success remained a significant predictor of MACE (adjusted HR 0.402; 95% CI 0.196-0.824; P = 0.013). Our study emphasizes the importance of CTO recanalization in improving long-term outcome including all-cause mortality with a borderline effect on cardiovascular mortality. © 2018, International Heart Journal Association. All rights reserved.

[No abstract available]

BACKGROUND: Current evidence on the long-term outcome and its determinants in patients with unprotected left main trifurcation (LMT) treated with percutaneous coronary intervention (PCI) is based on small-sized studies. We aimed to assess the clinical, anatomical and procedural factors impacting long-term clinical outcomes of patients with LMT treated by PCI. METHODS: We conducted a multicenter retrospective study on consecutive patients with unprotected LMT in stable or acute coronary settings who underwent PCI with drug-eluting-stent implantation. Primary endpoint was major adverse cardiovascular events (MACE), defined as composite of all-cause death, myocardial infarction, and target lesion revascularization. LMT lesions complexity was graded according to a modified Medina LMT score, which, together with standard criteria of >50% stenosis in any of the branches, included the presence of disease extent >5 mm in the two major side-branches. RESULTS: A total of 103 patients were analyzed, mean age 67.5 years, 37.9% with diabetes mellitus, 47.6% presenting with acute coronary syndrome, 8.7% in cardiogenic shock, with a mean SYNTAX Score of 28.1. Procedural success (angiographic success without in-hospital MACE) was achieved in 99 patients (96.1%). During 3-year follow-up, 18 patients (17.9%) experienced MACE, mainly due to target lesion revascularization (TLR), which occurred in 12 patients (11.9%). At multivariable analysis, modified Medina LMT score was the only independent predictor of MACE (HR 1.538 [1.081-2.189], P=0.017). CONCLUSIONS: PCI in patients with LMT is associated with a high procedural success rate and acceptable long-term clinical outcomes. Baseline LMT lesion complexity, assessed by an original modified Medina LMT score, is an independent driver of long-term clinical outcomes. © 2024 EDIZIONI MINERVA MEDICA.

Background: Elective unprotected left main (ULM) percutaneous coronary intervention (PCI) has long-term mortality rates comparable to surgical revascularization, thanks to advances in drug-eluting stent (DES) design, improved PCI techniques, and frequent use of intravascular imaging. However, urgent PCI of ULM culprit lesions remains associated with high in-hospital mortality and unfavourable long-term outcomes, including DES restenosis and stent thrombosis (ST). This analysis aimed to examine the long-term outcomes and healing of DES implanted in ULM during primary PCI using high-resolution optical coherence tomography (OCT) imaging. Methods: A total of 15 consecutive patients undergoing long-term OCT follow-up of ULM primary PCI from a high-volume center were included in this analysis. During the index primary PCI all subjects underwent angio-guided DES implantation, and follow-up was uneventful in all but one subject who had a non-target PCI lesion. The primary endpoint was the percentage of covered, uncovered, and malappossed stent struts at long-term follow-up. Secondary endpoints included quantitative and qualitative OCT measurements. For the left main bifurcation, a separate analysis was performed for three different segments: left main (LM), polygon of confluence (POC) and distal main branch (dMB), in all cases. Results: The average follow-up interval until OCT was 1580 ± 1260 days. Despite aorto-ostial stent protrusions in 40% of patients, optimal image quality was achieved in 93.3% of cases. There were higher rates of malapposed (11.4 ± 16.6 vs. 13.1 ± 8.3 vs. 0.3 ± 0.5%; p < 0.001) and lower rates of covered struts (81.7 ± 16.8 vs. 83.7 ± 9.2 vs. 92.4 ± 6.8%; p = 0.041) observed for the LM and POC segment compared to the dMB. Significantly malapposed stent struts (>400 µm) were less likely to be covered at follow-up, than struts with a measured strut to vessel wall distance of <400 µm (15.4 ± 21.6 vs. 24.8 ± 23.9%; p = 0.011). Neoatherosclerosis was observed in 5 (33.3%) and restenotic neointimal hyperplasia (NIH) in 2 (13.3%) patients, requiring PCI in 33.3% of patients. Conclusions: Long-term OCT examination of DES implanted during primary PCI for culprit ULM lesions demonstrated high rates of incomplete strut coverage, late malapposition, and high subclinical DES failure rates. These negative OCT results highlight the need for image optimization strategies during primary PCI to improve DES-related long-term outcomes. © 2024 The Author(s). Published by IMR Press.

Aims: Previous studies indicated that a chronic total occlusion (CTO) in a non-infarct-related artery is linked to higher mortality mainly in the acute setting in patients with ST-elevation myocardial infarction (STEMI). Our aim was to assess the temporal distribution of mortality risk associated with non-culprit CTO over years after STEMI. Methods and results: The study included 8679 STEMI patients treated with primary percutaneous coronary intervention (PCI). Kaplan-Meier cumulative mortality curves for non-culprit CTO vs. no CTO were compared with log-rank test, with landmarks set at 30 days and 1 year. Adjusted Cox regression models were constructed to assess the impact of non-culprit CTO on mortality over different time intervals. Tests for interaction were pre-specified between non-culprit CTO and acute heart failure and left ventricular ejection fraction. The primary outcome variable was all-cause mortality, and the median follow-up was 5 years. Non-culprit CTO was present in 11.6% of patients (n = 1010). Presence of a CTO was associated with increased early [30-day adjusted hazard ratio (HR) 1.91, 95% confidence interval (CI) 1.54-2.36; P < 0.001] and late mortality (5-year adjusted HR 1.66, 95% CI 1.42-1.95; P < 0.001). Landmark analyses revealed an annual two-fold increase in mortality in patients with vs. without a CTO after the first year of follow-up. The observed pattern of mortality increase over time was independent of acute or chronic LV impairment. Conclusions: Non-culprit CTO is independently associated with mortality over 5 years after primary PCI for STEMI, with a constant annual two-fold increase in the risk of death beyond the first year of follow-up. © 2021.

Background: Treatment of nonculprit coronary stenosis during primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction may be beneficial, but the mode and timing of the intervention are still controversial. The aim of this study was to examine the significance and prognostic value of preserved coronary flow velocity reserve (CFVR) in patients with nonculprit intermediate stenosis early after primary percutaneous coronary intervention. Methods: Two hundred thirty patients with remaining intermediate (50%–70%) stenosis of non-infarct-related arteries, in whom CFVR was performed within 7 days after primary percutaneous coronary intervention, were prospectively enrolled. Twenty patients with reduced CFVR and positive results on stress echocardiography or impaired fractional flow reserve underwent revascularization and were not included in further analysis. The final study population of 210 patients (mean age, 58 ± 10 years; 162 men) was divided into two groups on the basis of CFVR: group 1, CFVR > 2 (n = 174), and group 2, CFVR ≤ 2 (n = 36). Cardiac death, nonfatal myocardial infarction, and revascularization of the evaluated vessel were considered adverse events. Results: Mean follow-up duration was 47 ± 16 months. Mean CFVR for the whole group was 2.36 ± 0.40. There were six adverse events (3.4%) related to the nonculprit coronary artery in group 1, including one cardiac death, one ST-segment elevation myocardial infarction, and four revascularizations. In group 2, there were 30 adverse events (83.3%, P <.001 vs group 1), including two cardiac deaths, two ST-segment elevation myocardial infarctions, and 26 revascularizations. Conclusions: In patients with CFVR > 2 of the intermediate nonculprit coronary lesion, deferral of revascularization is safe and associated with excellent long-term clinical outcomes. © 2018 American Society of Echocardiography

This prospective, first-in-man, open-label multicenter study sought to assess the pharmacokinetics of sirolimus after Ultimaster drug-eluting stent implantation (coated with sirolimus and bioabsorbable co-polymer) in patients with de novo coronary artery disease (the TCD-10023 PK study). The primary endpoint was sirolimus concentration in peripheral whole blood at 28 days after stent implantation. In addition, safety, tolerability, therapeutic outcome and vasomotor response after stent implantation were studied. Twenty patients were enrolled in the study. Blood samples for the measurements of sirolimus concentration were collected at eight time points during first 48 h, at 7 days and 28 days after stent implantation. Patients underwent 6-month angiographic and up to 12 months clinical follow-up. At 28 days, only two of 20 patients had sirolimus concentrations above lower limit of quantification (20.0 pg/mL). The highest sirolimus blood concentration was 105 pg/mL. The median maximum concentration was 36.8 pg/mL (range 22.9-41.5 pg/mL) for stent 3.0 × 15 mm and 87.2 pg/mL (range 60.0-105.0 pg/mL) for 3 × 28 mm stent. The median systemic exposure, as measured by the area under the time-concentration curve, was 8.3 ng h/mL (range 6.47-28.0 ng h/mL). At 6 months, endothelial function was well preserved, and up to 12 months, there were no signs of sirolimus toxicity nor any other safety concerns. Our results demonstrate that implantation of Ultimaster stent resulted in almost nondetectable sirolimus in blood after 28 days. These findings were translated into exceptional safety profile, without any sign of systemic toxicity. © 2014 Société Française de Pharmacologie et de Thérapeutique.

This prospective, first-in-man, open-label multicenter study sought to assess the pharmacokinetics of sirolimus after Ultimaster drug-eluting stent implantation (coated with sirolimus and bioabsorbable co-polymer) in patients with de novo coronary artery disease (the TCD-10023 PK study). The primary endpoint was sirolimus concentration in peripheral whole blood at 28 days after stent implantation. In addition, safety, tolerability, therapeutic outcome and vasomotor response after stent implantation were studied. Twenty patients were enrolled in the study. Blood samples for the measurements of sirolimus concentration were collected at eight time points during first 48 h, at 7 days and 28 days after stent implantation. Patients underwent 6-month angiographic and up to 12 months clinical follow-up. At 28 days, only two of 20 patients had sirolimus concentrations above lower limit of quantification (20.0 pg/mL). The highest sirolimus blood concentration was 105 pg/mL. The median maximum concentration was 36.8 pg/mL (range 22.9-41.5 pg/mL) for stent 3.0 × 15 mm and 87.2 pg/mL (range 60.0-105.0 pg/mL) for 3 × 28 mm stent. The median systemic exposure, as measured by the area under the time-concentration curve, was 8.3 ng h/mL (range 6.47-28.0 ng h/mL). At 6 months, endothelial function was well preserved, and up to 12 months, there were no signs of sirolimus toxicity nor any other safety concerns. Our results demonstrate that implantation of Ultimaster stent resulted in almost nondetectable sirolimus in blood after 28 days. These findings were translated into exceptional safety profile, without any sign of systemic toxicity. © 2014 Société Française de Pharmacologie et de Thérapeutique.

Background: A considerable number of symptomatic patients leave the cardiac catheterization lab without a definitive diagnosis for their symptoms because no epicardial stenoses are found. The significance of disorders of coronary microvasculature and vasomotion as the cause of symptoms and signs of ischemia has only recently been appreciated. Today we have a wide spectrum of invasive coronary physiology tools but little is known about when and how these tools are used in clinical practice. Study design and methodology: SoutheAsTern eUrope microciRculATION (SATURATION) registry will study the regional practice of patient selection for coronary function testing, indications, non-invasive ischemia testing, medications, procedural aspects of invasive physiology evaluation, and treatment changes after testing. The registry is expected to include 1600 patients in participating centers in Southeastern Europe from 2024 to 2029, using the thermodilution technique for evaluation of microcirculation. Major adverse cardiovascular events as well as patient-centered outcomes such as burden of angina and quality of life using Seattle Angina Questionnaire (SAQ) and EQ-5D-5L will be recorded. The study will include patients with different stages of coronary artery disease (presence of disease or degree of stenosis) to elucidate the effect of coronary microcirculation on the outcomes in this broad group. Conclusion: The registry will provide information regarding the current practice of invasive coronary physiology assessment in populations at high cardiovascular risk in Southeastern Europe. This could lead to a better understanding of coronary microvascular dysfunction and its relationship to various degrees of coronary atherosclerosis together with potential interventions that can be beneficial. © 2024

The left-main coronary artery extrinsic compression due to enlarged pulmonary artery has been described in several case series. Ortner's syndrome is also a rare condition in some cardiovascular disorders. There have been no reports about these two rare conditions in the same patient. Hence, we report a very rare case of an Eisenmenger patient with severe pulmonary hypertension and dilated pulmonary artery which has compressed the left main coronary artery, severely narrowing it, and the left laryngeal recurrent nerve with subsequent Ortner's syndrome and brief literature review. © 2013 Elsevier Inc.