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Introduction: Nowadays, percutaneous closure of patent foramen ovale (PFO) in patients after cryptogenic stroke is becoming a dominating strategy. The most commonly used and investigated device is the Amplatzer occluder. However, several other devices have been designed for transcatheter closure of PFO, which are not so well examined., Aim: To assess the effectiveness and safety of PFO closure with the Lifetech CERA occluder., Material and Methods: A prospective, single-arm registry of patients with PFO treated with CERA occluder (Lifetech Scientific, Shenzhen, China) implantation was conducted. We assessed peri-procedural and 12-month follow-up. Patients were screened for the residual shunt in transcranial Doppler/transesophageal echocardiography., Results: Ninety-six patients entered the registry. Most patients were women (76%) and the analyzed group was relatively young (mean age of 42.3 ±13.6 years). Before closure, most patients had a large shunt through the PFO. Procedures of PFO closure were performed under TEE guidance. All procedures were made under local anesthesia and all patients had the PFO successfully closed. No device-related complications were reported in the peri-procedural period or during follow-up. No recurrent neurological ischemic events were reported at 12 months. During follow-up we observed a 9% rate of residual shunts, which were mostly small., Conclusions: The study confirmed excellent immediate and 12-month results of CERA occluder implantation in patients with PFO., Competing Interests: Przemysław Węglarz and Ewa Konarska-Kuszewska are members of the board and shareholders of Lifetech Scientific distributor and received remuneration for consultations, research and workshops., (Copyright: © 2023 Termedia Sp. z o. o.)

Introduction: A recent study suggested that sex discordance between surgeons and patients negatively affects the outcomes of patients undergoing common surgical procedures., Aim: We sought to assess whether such an impact exists for periprocedural outcomes of percutaneous coronary intervention (PCI)., Material and Methods: From 2014 to 2020, data on 581,744 patients undergoing single-stage coronary angiography and PCI from 154 centers were collected. Patients were divided into four groups based on the patient and operator sex. Operator-patient sex discordance was defined as the procedure done by a male operator on a female patient or by a female operator on a male patient., Results: Of 581,744 patients treated by 34 female and 782 male operators, 194,691 patients were sex discordant with their operator (female operator with male patient 12,479; male operator with female patient 182,212) while 387,053 were sex concordant (female operator with female patient 6,068; male operator with male patient 380,985). Among female patients, no difference in the risk of periprocedural complications, including death (0.65% vs. 0.82%; p = 0.10), between patients discordant versus concordant with operators was observed. Among male patients the risk of death (0.55% vs. 0.43%; p = 0.037) and bleeding at the puncture site (0.13% vs. 0.08%; p = 0.046) was higher in patients discordant with operators. However, the differences were no longer significant after adjustment for covariates., Conclusions: No detrimental effect of operator-patient sex discordance on periprocedural outcomes was confirmed in all-comer patients undergoing PCI. Some of the observed differences in outcomes were primarily related to the differences in baseline risk profile., Competing Interests: Dr. Mehran reports institutional research payments from Abbott, Abiomed, Alleviant Medical, Amgen, AM-Pharma, Arena, AstraZeneca, AtriCure, Bayer, Biosensors, Biotronik, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CeloNova, Chiesi, Concept Medical, CSL Behring, Cytosorbents, Daiichi Sankyo, Element Science, Faraday, Filterlex Medical, Humacyte, Idorsia, Janssen, Magenta, Mediasphere, Medtelligence, Medtronic, Novartis, OrbusNeich, Penumbra, PhaseBio, Philips, Pi-Cardia, PLx Pharma, Protembis, RenalPro, RM Global, Shockwave, Vivasure, Zoll; personal fees from Cine-Med Research, Ionis Pharmaceuticals, Novartis, Vectura, WebMD; Equity < 1% in Applied Therapeutics, Elixir Medical, Stel, ControlRad (spouse); Scientific Advisory Board for AMA, ACC (BOT Member), SCAI (Women in Innovations Committee Member), JAMA Cardiology Associate Editor; Faculty CRF (no fee). Other authors declare no conflict of interest., (Copyright: © 2023 Termedia Sp. z o. o.)

Introduction: Percutaneous coronary intervention (PCI) is a common method of treatment for patients with coronary artery disease. One of the most common complications during the PCI procedure is coronary artery dissection. It usually requires an additional action to assure the patency of the treated vessel., Aim: The aim of the publication is to describe the occurrence of coronary artery dissection after bioresorbable vascular scaffold (BVS) implantation. This selected type of PCI procedure is especially interesting because precise target vessel measurement before BVS implantation is required for optimal determination of scaffold size., Material and Methods: Based on angiographic data gathered in the POLAR ACS Registry, we assessed the frequency of dissections, their localization, and severity. Based on data regarding patients' demographic, clinical status, and details regarding treatment strategy, the factors that could have an influence on the dissection occurrence were identified., Results: A group of 100 patients included in the analyses. Group A consisted of 9 patients. This group was defined as patients in whom the significant dissection occurred after the BVS implantation. Group B comprised 91 patients. Both groups were very similar according to demographic data. The frequency of predilatation was similar; post-dilatation was performed more often in group A but without statistical significance. The presence of calcification in the target lesion was an independent factor of dissection during the index PCI procedure., Conclusions: The occurrence of significant dissection can be effectively treated, and the good angiographic results of this treatment immediately after the initial procedure translate into good clinical results in longer follow-up., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2022 Termedia Sp. z o. o.)

Introduction: The main impact of myocardial infarction is shifting from acute mortality to adverse remodeling and chronic left ventricle dysfunction. Several circulating biomarkers are explored for better risk stratification of these patients. Biomarker testing is a very attractive idea, since it is non-invasive, not operator-dependent and widely available., Aim: In the present paper we analyze data from the years 2005-2020 about circulating biomarkers of remodeling after myocardial infarction., Material and Methods: We assessed 53 articles, which examined 160 relations between biomarkers and remodeling. We analyze inclusion criteria for individual studies, time points of serum collection and remodeling assessment as well as imaging methods., Results: The main groups of assessed biomarkers included B-type natriuretic peptides, markers of cardiomyocyte injury and necrosis, markers of inflammatory response, markers of extracellular matrix turnover, microRNAs and hormones. The most common method of remodeling assessment was echocardiography and the most frequent time point for remodeling evaluation was 6 months., Conclusions: The present analysis shows that although a relatively large number biomarkers were tested, selecting one ideal marker is still a challenge. A combination of biomarkers from different groups might be appropriate for predicting remodeling. Data presented in this analysis might be helpful for designing future studies, evaluating clinical use of an individual biomarker or a combination of different biomarkers., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2021 Termedia Sp. z o. o.)

Introduction: Endovascular revascularization (ER) techniques in patients with peripheral artery disease (PAD) have been developed and became more accessible in recent years. The ER is a first-line treatment in the majority of patients with symptomatic PAD. However, data on assessment of predictors of long-term outcomes of retrograde ER in patients with PAD are scarce., Aim: To evaluate predictors of long-term outcomes of retrograde ER in patients with chronic total occlusion in lower limb arteries., Material and Methods: We analyzed data of 834 patients who underwent retrograde ER. Baseline clinical characteristics and procedural data were collected. Patients were followed up for 36 months, and the primary endpoint was all-cause mortality., Results: All patients were symptomatic and had failed antegrade ER. The procedural success rate was 92%. Cumulative all-cause mortality was 13.4% at 36-month follow-up. In multivariate analysis history of stroke, Rutherford category, chronic limb ischemia, chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD) and previous ER of other lesion were independent predictors of a higher mortality rate after 36 months (hazard ratio (HR) for stroke 2.4, 95% confidence interval (CI): 1.55-3.66; p = 0.0002; HR for age per 10 years 1.37, 95% CI: 1.15-1.64; p = 0.0002; HR for Rutherford category 1.63, 95% CI: 1.35-1.98; p < 0.0001, HR for chronic limb ischemia 0.44, 95% CI: 0.25-0.8, p = 0.007; HR for CKD 1.73, 95% CI: 1.14-2.56, p = 0.01; HR for COPD 2.4, 95% CI: 1.5-3.7, p = 0.0004; HR for previous ER 0.59, 95% CI: 0.35-0.94, p = 0.02)., Conclusions: History of stroke, Rutherford category, chronic limb ischemia, CKD, COPD, and previous ER of other lesion were independently associated with increased risk of all-cause death., Competing Interests: The authors declare no conflict of interest.

Introduction: Patients with peripheral artery disease (PAD) are considered as a high-risk group for hemorrhagic events., Aim: To assess the safety of bivalirudin vs. unfractionated heparin (UFH) in percutaneous peripheral interventions (PPI) in short- and long-term follow-up., Material and Methods: The retrospective single-center, observational study included 160 patients, undergoing PPI. Patients were divided into 2 groups based on the use of anticoagulation - unfractionated heparin (UFH group) or bivalirudin (Biv. group) - and observed up to 5 years., Results: The UFH group consisted of 101 patients and the Biv. group consisted of 59. We registered the following end points during in-hospital observation: 1 death (0.63% Biv, p = 0.18), 12 hematomas at puncture site (0.63% Biv. vs. 7.05% UFH, p = 0.04), 2 pseudoaneurysms (1.27% UFH, p = 0.29), thrombosis (0.63% UFH, p = 0.45), 1 bleeding from puncture site (0.63% UFH, p = 0.45). The total number of hemorrhagic complications was 1.24% in the Biv. group and 8.07% in the UFH group ( p = 0.04). During long-term follow-up of 65.7 ±36.4 months the all-cause mortality rate was higher in the Biv. group (8.59% Biv vs. 0% in UFH group, p = 0.009). Regression analysis showed that bivalirudin administration is a risk factor for increased mortality risk ( p = 0.003, OR = 15, 95% CI: 3.3-107.8)., Conclusions: Usage of UFH was associated with a higher number of hemorrhagic complications, especially hematomas at the puncture site in comparison to patients receiving bivalirudin., Competing Interests: The authors declare no conflict of interest.

Introduction: Many years of experience and refinement of existing rotational atherectomy (RA) techniques have resulted in improved clinical outcomes and a tendency to broaden the spectrum of RA usage., Aim: To compare the angiographic effectiveness and periprocedural complications in patients with stable angina (SA) and acute myocardial infarction (AMI) treated using RA., Material and Methods: Data were prospectively collected using the Polish Cardiovascular Intervention Society national registry (ORPKI) on all percutaneous coronary interventions (PCIs) performed in Poland in 2015 and 2016. In total, 975 RA procedures were recorded out of 221,187 PCI procedures., Results: We compared angiographic effectiveness and periprocedural complications in 530 patients with SA and 245 with AMI in the RA group of patients, and 60,522 patients with SA and 91,985 with AMI in the non-RA group. The overall rate of periprocedural complications did not differ between SA and AMI patients in the RA group (2.3% vs. 2.0%; p = 0.84), while it was lower in AMI patients from the RA group compared to those from the non-RA group (2.0% vs. 3.0%; p = 0.34). The percentage of patients with angiographic success in the RA group was similar to the non-RA group in SA patients (97.3% vs. 97.1%; p = 0.75), whereas in the AMI group it was significantly higher compared to the non-RA group (96.7% vs. 92.6%; p < 0.001)., Conclusions: The angiographic effectiveness of PCI with RA in patients with AMI was not worse than in patients with SA.

Introduction: The CHA 2 DS 2 -VASc and R 2 -CHA 2 DS 2 -VASc scores were initially designed to evaluate the risk of cerebrovascular events in patients with atrial fibrillation. However, these scales consist of parameters which are well known as general risk factors for cardiovascular events., Aim: To assess the role of the CHA 2 DS 2 -VASc and R 2 -CHA 2 DS 2 -VASc scores in predicting outcome of patients with myocardial infarction (MI)., Material and Methods: We enrolled 212 consecutive patients with both ST-elevation and non-ST-elevation MI referred for primary percutaneous coronary intervention (PCI). Patients were divided into two groups depending on the CHA 2 DS 2 -VASc score: ≤ 3 (low score) and > 3 points (high score)., Results: The group with a CHA 2 DS 2 -VASc score > 3 points consisted of 93 (44%) patients. Follow-up was available in 200 (94.3%) patients with median duration of 10 (Q1: 6; Q3: 13) months. During the follow-up all-cause mortality was greater in patients from the high score group (21%) compared to patients with lower scores (8%) ( p = 0.009). Recurrent MI was found in 4% of patients from the low score group and in 13% of patients from the high score group ( p = 0.024). The combined endpoint of cardiovascular mortality, recurrent non-fatal MI and non-fatal stroke occurred in 13% of lower score patients and in 30% of patients with a score > 3 points ( p = 0.002). In a Cox regression model both scores were predictors of all-cause mortality with a hazard ratio of 1.31 per 1 point increase for the CHA 2 DS 2 -VASc score ( p = 0.004) and 1.36 for the R 2 -CHA 2 DS 2 -VASc score ( p < 0.001)., Conclusions: The CHA 2 DS 2 -VASc and R 2 -CHA 2 DS 2 -VASc scores predict in-hospital and post-discharge outcome in patients with acute MI undergoing primary PCI.

Introduction: Fifty percent of cases of peripheral artery disease are caused by chronic total occlusion (CTO) of the superficial femoral artery (SFA). Ten-fifteen percent of percutaneous SFA recanalization procedures are unsuccessful. In those cases the retrograde technique can increase the success rate of the procedure, but the long-term follow-up of such procedures is still unknown., Aim: To assess the efficacy and clinical outcomes during long-term follow-up after retrograde recanalization of the SFA., Material and Methods: We included patients after at least one unsuccessful percutaneous antegrade recanalization of the SFA. Patients were evaluated for the procedural and clinical follow-up of mean time 13.9 months., Results: The study included 17 patients (7 females, 10 males) who underwent percutaneous retrograde recanalization of the SFA from June 2011 to June 2015. The mean age of patients was 63 ±7 years. Retrograde puncture of the distal SFA was successful in all cases. A retrograde procedure was performed immediately after antegrade failure in 4 (23.5%) patients and after a previously failed attempt in 13 (76.5%) patients. The procedure was successful in 15 (88.2%) patients, and unsuccessful in 2 (11.8%) patients. Periprocedural complications included 1 peripheral distal embolization (successfully treated with aspiration thrombectomy), 1 bleeding event from the puncture site and 7 puncture site hematomas. During follow-up the all-cause mortality rate was 5.8% (1 patient, non-cardiac death). The primary patency rate at 12 months was 88.2% and secondary patency 100%., Conclusions: The retrograde SFA puncture seems to be a safe and successful technique for CTO recanalization and is associated with a low rate of perioperative and long-term follow-up complications., Competing Interests: The authors declare no conflict of interest.

Introduction: There are scarce data on the usefulness of manual thrombectomy among patients with non-ST-elevation myocardial infarction (NSTEMI). Early positive reports were not supported by the clinical outcome in the recent TATORT-NSTEMI (Thrombus Aspiration in Thrombus Containing Culprit Lesions in Non-ST-Elevation Myocardial Infarction) study., Aim: To analyze the long-term outcome of NSTEMI patients treated with manual thrombectomy during percutaneous coronary intervention (PCI) in the Polish multicenter National Registry of Drug Eluting Stents (NRDES) study., Material and Methods: There were 13 catheterization laboratories in Poland that enrolled patients in NRDES Registry in 2010-2011. Patients with a diagnosis of NSTEMI were divided into two groups: those that were treated with manual thrombectomy for their primary PCI (T) and those who were not (NT)., Results: There were 923 patients diagnosed with NSTEMI in NRDES. Aspiration thrombectomy was used in 71 (7.7%) patients and the remaining 852 (92.3%) NSTEMI cases were treated without thrombectomy during the index PCI. Thrombectomy was more often used in patients with TIMI less than 1, thrombus grades 4 and 5 and older male patients. Percutaneous coronary interventions complications such as distal embolization and slow flow were more often observed in the thrombectomy subgroup. Overall mortality at 1 year was 1.69% in the T and 5.92% in the NT group (p = 0.24 and p = 0.32 after propensity score matching adjustment with p = 0.11 in the multivariate logistic regression model)., Conclusions: There was no mortality benefit from thrombus aspiration in NSTEMI patients at 1-year follow-up.

Introduction: There are still limited data on the occurrence of multiple stenotic lesions within the infarct-related artery (IRA) in acute myocardial infarction (MI), and there is no consensus on the optimal treatment of this patient subgroup, which varies between centers and operators., Aim: To analyse the clinical efficacy of percutaneous coronary intervention (PCI) strategy of culprit lesion only in patients with myocardial infarction., Material and Methods: Patients with acute MI with the presence of at least two significant lesions in the IRA - (1) the target culprit lesion which required immediate stenting (> 50-100% stenosis) and (2) a second distal critical lesion (70-90%) - were included in the registry. Both lesions in the IRA were considered to be independent lesions requiring two separate stent platforms to be covered (no overlap). The decision on the treatment strategy of either complete (CR) or culprit-lesion-only (CLO) revascularization was at the discretion of the operator., Results: There were altogether 95 patients enrolled in the registry, 63 (66%) in the group with CR of the IRA and 32 (34%) with CLO revascularization, which did not differ in terms of baseline demographics. In-hospital and long-term outcomes were similar between the groups. Stent thrombosis at 1 year occurred in 1.6% in CR and in 6.2% in CLO groups respectively (statistically not significant). There were no patients from the CLO group who had a planned percutaneous coronary intervention (PCI) of the 2(nd) lesion in the IRA during 1-year observation., Conclusions: At 1 year the clinical outcome was similar between those with complete and CLO PCI. Complete coverage of significant lesions did not increase the risk of stent thrombosis or need for repeated revascularization in long-term observation.

Introduction: A large, randomised trial (IABP-SHOCK II) confirmed no benefit of intra-aortic balloon pump (IABP) on clinical outcomes of patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock. However, the 'sickest' patients are often excluded from randomised clinical trials, so it is difficult to generalise expected outcomes from randomized clinical trials to the real life setting., Aim: We sought to evaluate the impact of IABP on 1-year mortality of unselected patients with STEMI presenting in cardiogenic shock., Material and Methods: Data were gathered for 1,650 consecutive patients with STEMI transferred for primary angioplasty from hospital networks in 7 countries in Europe from November 2005 to January 2007 (the EUROTRANSFER registry population). Of them, 51 patients with cardiogenic shock on admission were identified and stratified based on the use of IABP. Outcome results were adjusted for age and sex, to control possible selection bias., Results: At the discretion of the operators, IABP was applied in 30 patients (58.8%, IABP group). The remaining 21 patients were treated without IABP (no-IABP group). The use of IABP was more frequent among males, younger patients, and patients with STEMI of the anterior wall. There was no difference in 30-day mortality in patients with and without IABP (no-IABP vs. IABP: 38.1% vs. 33.3%; adjusted OR 1.79 (95% CI 0.43-7.52); p = 0.43). Similarly, IABP had no impact on 1-year mortality (42.9% vs. 33.3%; adjusted OR 1.27 (95% CI 0.32-5.09); p = 0.74). One-year mortality was comparable among patients who survived hospitalisation (14.3% vs. 13%; p = 0.64)., Conclusions: We observed no benefit of IABP on short - and long-term mortality of unselected patients with STEMI complicated by cardiogenic shock.

Introduction: Most endovascular techniques are associated with patient and personal exposure to radiation during the procedure. Ionising radiation can cause deterministic effects, such as skin injury, as well as stochastic effects, which increase the long-term risk of malignancy. Endovascular operators need to be aware of radiation danger and take all necessary steps to minimise the risk to patients and staff. Some procedures, especially percutaneous peripheral artery revascularisation, are associated with increased radiation dose due to time-consuming operations. There is limited data comparing radiation dose during percutaneous coronary intervention (PCI) with percutaneous transluminal angioplasty (PTA) of peripheral arteries., Aim: To compare the radiation dose in percutaneous coronary vs. peripheral interventions in one centre with a uniform system of protection methods., Material and Methods: A total of 352 patients were included in the study. This included 217 patients undergoing PCI (single and multiple stenting) and 135 patients undergoing PTA (in lower extremities, carotid artery, renal artery, and subclavian artery). Radiation dose, fluoroscopy time, and total procedural time were reviewed. Cumulative radiation dose was measured in gray (Gy) units., Results: The total procedural time was significantly higher in PTA (PCI vs. PTA: 60 (45-85) min vs. 75 (50-100) min), p < 0.001. The radiation dose for PCI procedures was significantly higher in comparison to PTA (PCI vs. PTA: 1.36 (0.83-2.23) Gy vs. 0.27 (0.13-0.46) Gy), p < 0.001. There was no significant difference in the fluoroscopy time (PCI vs. PTA: 12.9 (8.2-21.5) min vs. 14.4 (8.0-22.6) min), p = 0.6. The analysis of correlation between radiation dose and fluoroscopy time in PCI and PTA interventions separately shows a strong correlation in PCI group (r = 0.785). However, a weak correlation was found in PTA group (r = 0.317)., Conclusions: The radiation dose was significantly higher during PCI in comparison to PTA procedures despite comparable fluoroscopy time and longer total procedure time in PTA. Fluoroscopy time is a reliable parameter to control the radiation dose exposure in coronary procedures. The increasing complexity of endovascular interventions has resulted in the increase of radiation dose exposure during PCI procedures.