Long-Term Outcomes Following Sirolimus-Coated Balloon or Drug-Eluting Stents for Treatment of In-Stent Restenosis.

BACKGROUND: Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting. METHODS: All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up. RESULTS: A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P=0.329), target vessel revascularization (14.0% versus 13.1%; P=0.822), myocardial infarction (7.2% versus 4.5%; P=0.186), all-cause death (5.7% versus 4.2%; P=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P=0.242) between DES and SCB treatment. CONCLUSIONS: In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.

Incidence and predictors of 2-year mortality following percutaneous left atrial appendage occlusion in the EWOLUTION trial.

AIMS: Sufficient survival time following left atrial appendage occlusion (LAAO) is essential for ensuring the efficacy and cost-effectiveness of this strategy for stroke prevention. Understanding prognostic factors for early mortality after LAAO could optimize patient selection. In the current study, we perform an in-depth analysis of 2-year mortality after LAAO, focusing particularly on potential predictors. METHODS AND RESULTS: The EWOLUTION registry is a real-world cohort comprising 1020 patients that underwent LAAO. Endpoint definitions were pre-specified, and death was categorized as cardiovascular, non-cardiovascular, or unknown origin. Mortality rates were calculated from Kaplan-Meier estimates. Baseline characteristics significantly associated with death in univariate Cox regression analysis were incorporated into the multivariate analysis. All multivariate predictors were included in a risk model. Two-year mortality rate was 16.4% [confidence interval (CI): 14.0-18.7%], with 50% of patients dying from a non-cardiovascular cause. Multivariate baseline predictors of 2-year mortality included age [hazard ratio (HR) 1.05, CI: 1.03-1.08, per year increase], heart failure (HR 1.73, CI: 1.24-2.41), vascular disease (HR 1.47, CI: 1.05-2.05), valvular disease (HR 1.63, CI: 1.15-2.33), abnormal liver function (HR 1.80, CI: 1.02-3.17), and abnormal renal function (HR 1.58, CI: 1.10-2.27). Mortality rate exhibited a gradual rise as the number of risk factors increased, reaching 46.1% in patients presenting with five or six risk factors. CONCLUSION: One in six patients died within 2 years after LAAO. We identified six independent predictors of mortality. When combined, this model showed a gradual increase in mortality rate with a growing number of risk factors, which may guide appropriate patient selection for LAAO. CLINICAL TRIAL REGISTRATION: The original EWOLUTION registry was registered at clinicaltrials.gov under identifier NCT01972282.

Extracellular Vesicles to Predict Outcomes After Transcatheter Aortic Valve Implantation - a Prospective, Multicenter Cohort Study.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is an established treatment for aortic stenosis (AS) in patients at intermediate and high surgical risk. Circulating extracellular vesicles (EVs) are nanoparticles involved in cardiovascular diseases. We aimed to (i) determine the effect of TAVI on plasma concentrations of five EV subtypes and (ii) evaluate the predictive value of EVs for post-TAVI outcomes. METHODS: Blood samples were collected 1 day before TAVI and at hospital discharge. Concentrations of EVs were evaluated using flow cytometry. RESULTS: Concentration of leukocytes EVs decreased after TAVI, compared to the measurement before (p = 0.008). Among 123 patients discharged from the hospital, 19.5% experienced MACCE during the median of 10.3 months. Increased pre-TAVI concentration of phosphatidylserine-exposing EVs was an independent predictor of MACCE in multivariable analysis (OR 5.313, 95% CI 1.164-24.258, p = 0.031). CONCLUSIONS: Patients with increased pre-TAVI concentration of procoagulant, PS-exposing EVs have over fivefold higher odds of adverse outcomes.

Indirect impact of the war in Ukraine on primary percutaneous coronary intervention for ST-segment elevation myocardial infarction in Poland.

INTRODUCTION: The Russian invasion of Ukraine in February 2022 resulted in displacement of approximately 12.5 million refugees to adjacent countries, including Poland, which may have strained health care service delivery. OBJECTIVES: Using the ST­segment elevation myocardial infarction (STEMI) data, we aimed to evaluate whether the Russian invasion of Ukraine has indirectly impacted delivery of acute cardiovascular care in Poland. PATIENTS AND METHODS: We analyzed all adult patients undergoing percutaneous coronary interventions (PCIs) for STEMI across Poland between February 25, 2017 and May 24, 2022. The investigated health care centers were allocated to regions below and over 100 km from the Polish-Ukrainian border. Mixed­effect generalized linear regression models with random effects per hospital were used to explore the associations between the war in Ukraine and several parameters, and whether these associations differed across the regions below and over 100 km from the border. RESULTS: A total of 90 115 procedures were included in the analysis. The average number of procedures per month was similar to the predicted volume for centers over 100 km from the border, while it was higher than expected (by an estimated median of 15 [interquartile range, 11-19]) for the region below 100 km from the border. There was no difference in adjusted fatality rate or quality of care outcomes for pre- and during­war time in both regions, with no evidence of a difference­in­difference across the regions. CONCLUSIONS: Following the Russian invasion of Ukraine, there was only a modest and temporary increase in the number of primary PCIs, predominantly in the centers situated within 100 km of the Polish-Ukrainian border, although no significant impact on in­hospital fatality rate was found.

Outcomes With Hybrid Catheter-Directed Therapy Compared With Aspiration Thrombectomy for Patients With Intermediate-High Risk Pulmonary Embolism.

PURPOSE: Intermediate-high-risk pulmonary embolism (IHR PE) is a challenging form of embolism obstruction that causes right ventricular (RV) dysfunction. The optimal management of IHR PE has not been established. This single-center prospective, observational study aimed to evaluate the efficacy and safety of complex catheter-directed therapy (CDT) - catheter-directed mechanical aspiration thrombectomy (CDMT) supplemented with catheter-directed thrombolysis (hybrid CDT) in comparison to CDMT alone for IHR PE. METHODS: A propensity score based on the pulmonary embolism severity index class and Miller obstruction index (MOI) was calculated, and 21 hybrid CDT cases (mean age 54.8 (14.7) years, 9/21 women) were matched with 21 CDMT cases (mean age 58.8 (14.9) years, 13/21 women). The baseline demographics, clinical, and treatment characteristics were analyzed. RESULTS: No significant differences were detected regarding baseline demographics and PE severity parameters. Hybrid CDT demonstrated a higher reduction in mean pulmonary artery pressure (mPAP) (hybrid CDT: median mPAP reduction 8 mmHg (IQR: 6-10 mmHg) vs CDMT: median mPAP reduction 6 mmHg (IQR: 4-7 mmHg); P = 0.019), MOI score (hybrid CDT: median change - 5 points (IQR: 5-6 points) vs CDMT median change - 3 points (IQR: 3-5 points); P = 0.019), and median RV: left ventricular ratio (hybrid CDT: median change 0.4 (IQR: 0.3-0.45) vs CDMT median change 0.26 (IQR: 0.2-0.4); P = 0.007). No major bleeding was observed. Both the hybrid CDT and CDMT alone treatments are safe and effective in managing IHR PE. CONCLUSIONS: Hybrid CDT is a promising technique for the management of IHR PE with insufficient thrombus load reduction by CDMT. TRIAL REGISTRATION: NCT0447356-registration date 16 July 2020.

Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial.

BACKGROUND: Both transcatheter edge-to-edge repair (TEER) of mitral regurgitation or left atrial appendage closure (LAAC) require periprocedural anticoagulation with unfractionated heparin (UFH) that is administered either before or immediately after transseptal puncture (TSP). The optimal timing of UFH administration (before or after TSP) is unknown. The Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions trial (STOP CLOT Trial) was designed to determine if early anticoagulation is effective in reducing ischemic complications without increasing the risk of periprocedural bleeding. METHODS: The STOP CLOT trial is a multicenter, prospective, double-blind, placebo-controlled, randomized trial. A total of 410 patients scheduled for TEER or LAAC will be randomized 1:1 either early UFH administration (iv. bolus of 100 units/kg UFH or placebo, given after obtaining femoral vein access and at least 5 minutes prior to the start of the TSP) or late UFH administration (iv. bolus of 100 units/kg UFH or placebo given immediately after TSP). Prespecified preliminary statistical analysis will be performed after complete follow-up of the first 196 randomized subjects. To ensure blinding, a study nurse responsible for randomization and UFH/placebo preparation is not involved in the care of the patients enrolled into the study. The primary study endpoint is a composite of (1) major adverse cardiac and cerebrovascular events (death, stroke, TIA, myocardial infarction, or peripheral embolization) within 30 days post-procedure, (2) intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transesophageal echocardiography, or (3) occurrence of new ischemic lesions (diameter ≥4 mm) on brain magnetic resonance imaging performed 2 to 5 days after the procedure. The safety endpoint is the occurrence of moderate or severe bleeding complications during the index hospitalization. CONCLUSIONS: Protocols of periprocedural anticoagulation administration during structural interventions have never been tested in a randomized clinical trial. The Stop Clot trial may help reach consensus on the optimal timing of initiation of periprocedural anticoagulation. CLINICAL TRIALS REGISTRATION NUMBER: The study protocol is registered at ClinicalTrials.gov, identifier NCT05305612.

Implementation of Microcirculation Examination in Clinical Practice-Insights from the Nationwide POL-MKW Registry.

Background and Objectives: The assessment of coronary microcirculation may facilitate risk stratification and treatment adjustment. The aim of this study was to evaluate patients' clinical presentation and treatment following coronary microcirculation assessment, as well as factors associated with an abnormal coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) values. Materials and Results: This retrospective analysis included 223 patients gathered from the national registry of invasive coronary microvascular testing collected between 2018 and 2023. Results: The frequency of coronary microcirculatory assessments in Poland has steadily increased since 2018. Patients with impaired IMR (≥25) were less burdened with comorbidities. Patients with normal IMR underwent revascularisation attempts more frequently (11.9% vs. 29.8%, p = 0.003). After microcirculation testing, calcium channel blockers (CCBs) and angiotensin-converting enzyme inhibitors were added more often for patients with IMR and CFR abnormalities, respectively, as compared to control groups. Moreover, patients with coronary microvascular dysfunction (CMD, defined as CFR and/or IMR abnormality), regardless of treatment choice following microcirculation assessment, were provided with trimetazidine (23.2%) and dihydropyridine CCBs (26.4%) more frequently than those without CMD who were treated conservatively (6.8%) and by revascularisation (4.2% with p = 0.002 and 0% with p < 0.001, respectively). Multivariable analysis revealed no association between angina symptoms and IMR or CFR impairment. Conclusions: The frequency of coronary microcirculatory assessments in Poland has steadily increased. Angina symptoms were not associated with either IMR or CFR impairment. After microcirculation assessment, patients with impaired microcirculation, expressed as either low CFR, high IMR or both, received additional pharmacotherapy treatment more often.

Practical guide on left atrial appendage closure for the non-implanting physician: an international consensus paper.

A significant proportion of patients who suffer from atrial fibrillation (AF) and are in need of thromboembolic protection are not treated with oral anticoagulation or discontinue this treatment shortly after its initiation. This undertreatment has not improved sufficiently despite the availability of direct oral anticoagulants which are associated with less major bleeding than vitamin K antagonists. Multiple reasons account for this, including bleeding events or ischaemic strokes whilst on anticoagulation, a serious risk of bleeding events, poor treatment compliance despite best educational attempts, or aversion to drug therapy. An alternative interventional therapy, which is not associated with long-term bleeding and is as effective as vitamin K anticoagulation, was introduced over 20 years ago. Because of significant improvements in procedural safety over the years, left atrial appendage closure, predominantly achieved using a catheter-based, device implantation approach, is increasingly favoured for the prevention of thromboembolic events in patients who cannot achieve effective anticoagulation. This management strategy is well known to the interventional cardiologist/electrophysiologist but is not more widely appreciated within cardiology or internal medicine. This article introduces the devices and briefly explains the implantation technique. The indications and device follow-up are more comprehensively described. Almost all physicians who care for adult patients will have many with AF. This practical guide, written within guideline/guidance boundaries, is aimed at those non-implanting physicians who may need to refer patients for consideration of this new therapy, which is becoming increasingly popular.

Multicenter registry of Impella-assisted high-risk percutaneous coronary interventions and cardiogenic shock in Poland (IMPELLA-PL).

BACKGROUND: Impella is a percutaneous mechanical circulatory support device for treatment of cardiogenic shock (CS) and high-risk percutaneous coronary interventions (HR-PCIs). IMPELLA-PL is a national retrospective registry of Impella-treated CS and HR-PCI patients in 20 Polish interventional cardiological centers, conducted from January 2014 until December 2021. AIMS: We aimed to determine the efficacy and safety of Impella using real-world data from IMPELLA-PL and compare these with other registries. METHODS: IMPELLA-PL data were analyzed to determine primary endpoints: in-hospital mortality and rates of mortality and major adverse cardiovascular and cerebrovascular events (MACCE) at 12 months post-discharge. RESULTS: Of 308 patients, 18% had CS and 82% underwent HR-PCI. In-hospital mortality rates were 76.4% and 8.3% in the CS and HR-PCI groups, respectively. The 12-month mortality rates were 80.0% and 18.2%, and post-discharge MACCE rates were 9.1% and 22.5%, respectively. Any access site bleeding occurred in 30.9% of CS patients and 14.6% of HR-PCI patients, limb ischemia in 12.7% and 2.4%, and hemolysis in 10.9% and 1.6%, respectively. CONCLUSIONS: Impella is safe and effective during HR-PCIs, in accordance with previous registry analyses. The risk profile and mortality in CS patients were higher than in other registries, and the potential benefits of Impella in CS require investigation.

Cardiac Post-Chest Radiotherapy Complications in a 50-Year-Old Patient with Hodgkin Lymphoma.

Lymphomas are a group of malignant tumors that originate in the lymphatic system. It is the most common type of blood cancer. It affects the lymph nodes, spleen, bone marrow, blood, and other organs. They can be aggressive or chronic. Hodgkin lymphoma survival rate is 2 in 100,000 people. Young adults aged 20-30 and people over 50 are most often affected. The prognosis of Hodgkin's lymphoma is good, with a survival rate of up to 80 percent. Nevertheless, in 20-30 percent of patients who initially respond to treatment, the disease has a tendency to progress. The positive effect of radiotherapy (RT) on patients' survival rates has been proven in many randomized clinical trials. Although the dose of chest RT has significantly reduced over the years, we still struggle with the long-term complications of post-RT repercussions, mainly because there is no established safe dose of RT affecting the heart. Other complications include earlier onset of coronary artery disease, early and late onset of pericarditis, valve degeneration (predominantly of the left heart), calcification of the aorta and its branches, heart failure, and arrhythmias. One patient can manifest each of the abovementioned complications, as in the present case. That is why choosing the right treatment strategy is crucial.

Long-term mortality after transcatheter aortic valve implantation for aortic stenosis in immunosuppression-treated patients: a propensity-matched multicentre retrospective registry-based analysis.

Introduction: Data regarding patients with a previous medical record of immunosuppression treatment who have undergone transcatheter aortic valve implantation (TAVI) are limited and extremely inconclusive. Available studies are mostly short term observations; thus there is a lack of evidence on efficacy and safety of TAVI in this specific group of patients. Aim: To compare the in-hospital and long-term outcomes between patients with or without a medical history of immunosuppressive treatment undergoing TAVI for aortic valve stenosis (AS). Material and methods: We conducted a retrospective registry-based analysis including patients undergoing TAVI for AS at 5 centres between January 2009 and August 2017. The primary endpoint was long-term all-cause mortality. Secondary endpoints comprised major vascular complications, life-threatening or disabling bleeding, stroke and new pacemaker implantation. Results: Of 1451 consecutive patients who underwent TAVI, two propensity-matched groups including 25 patients with a history of immunosuppression and 75 patients without it were analysed. No differences between groups in all-cause mortality were found in a median follow-up time of 2.7 years following TAVI (p = 0.465; HR = 0.73; 95% CI: 0.30-1.77). The rate of major vascular complications (4.0% vs. 5.3%) was similar in the two groups (p = 1.000). There were no statistically significant differences in the composite endpoint combining life-threatening or disabling bleeding, major vascular complications, stroke and new pacemaker implantation (40.0% vs. 20.0%, p = 0.218). Conclusions: Patients who had undergone TAVI for AS had similar long-term mortality regardless of whether they had a previous medical record of immunosuppression. Procedural complication rates were comparable between the groups.

Management of myocardial infarction complicated by cardiogenic shock: Expert opinion of the Association of Intensive Cardiac Care and Association of Cardiovascular Interventions of the Polish Society of Cardiology.

Despite significant advances in interventional cardiology and mechanical circulatory support (MCS) techniques, outcomes for patients with myocardial infarction (MI) complicated by cardiogenic shock (CS) remain suboptimal. This expert consensus aims to provide information on the current management of patients with MI complicated by CS in Poland and to propose solutions, including systemic ones, for all stages of care. The document uses data from the Polish PL-ACS Registry of Acute Coronary Syndromes, which includes records of more than 820 000 hospital admissions. We describe the role of medical rescue teams, highlighting the necessity to expand their range of competencies at the level of prehospital care. We emphasize the importance of treating the underlying cause of CS and direct patient transfer to centers capable of performing percutaneous coronary interventions. We present current recommendations of scientific societies on MCS use. We underline the role of the Cardiac Shock Team in the management of patients with MI complicated by CS. Such teams should comprise an interventional cardiologist, a cardiothoracic surgeon, and an intensive care physician. Patients should be transferred to highly specialized CS centers, following the example of so-called Cardiac Shock Care Centers described in some other countries. We propose criteria for the operation of such centers Other important aspects discussed in the document include the role of rehabilitation, multidisciplinary care, and long-term follow-up of treatment outcomes. The document was developed in cooperation with experts from different scientific societies in Poland, which illustrates the importance of interdisciplinary care in this patient population.

Monocyte-to-lymphocyte ratio correlates with parathyroid hormone concentration in patients with severe symptomatic aortic stenosis.

PURPOSE: The normal healthy valve is devoid of inflammatory cells, however background of aortic stenosis (AS) may include inflammatory processes. Moreover, the link between hyperparathyroidism and heart failure is postulated. Simple whole blood analysis with indices is a beneficial tool in cardiovascular diseases' assessment. The purpose of the study was to evaluate correlation between parathyroid hormone (PTH) and simple blood parameters in severe AS. MATERIAL AND METHODS: The study included 62 patients with severe AS. Patients with inflammatory or autoimmune co-morbidities were excluded. Blood samples were collected, and clinical and demographic data were analyzed. RESULTS: The final study group comprised 55 patients (31 females, 56.4%; mean age 77.13 (SD 6.76)). In 23 patients (41.8%), PTH concentration was markedly increased. The study group was divided into two subgroups according to the PTH concentration. Patients from both groups did not differ significantly in terms of age and co-morbidities. PTH concentration correlated positively with monocyte-lymphocyte ratio (MLR) (p â€‹= â€‹0.008, Spearman rho 0.356) and platelet-lymphocyte ratio (PLR) (p â€‹= â€‹0.047, Spearman rho 0.269), creatinine level (p â€‹= â€‹0.001, Spearman rho 0.425) and glomerular filtration rate (GFR-MDRD) (p â€‹= â€‹0.009, Spearman rho -0.349). The multivariable logistic regression with backward analysis revealed MLR (p â€‹= â€‹0.029) and GFR (p â€‹= â€‹0.028) as independent significant predictors of abnormal PTH values. The receiver operator characteristics (ROC) curve was performed for the model of MLR and GFR-MDRD (AUC â€‹= â€‹0.777), yielding the sensitivity of 60.9% and specificity of 90.6%. CONCLUSIONS: PTH concentration correlates with monocyte-to-lymphocyte and platelet-to-lymphocyte ratios in calcified AS.