Multicentre short- and medium-term report on the device closure of a post-myocardial infarction ventricular septal rupture - In search of risk factors for early mortality.

BACKGROUND: Post-myocardial infarction ventricular septal rupture (VSR) is a rare and severe complication of myocardial infarction. To find early mortality (<30 days) risk factors of device VSR closure and to evaluate its medium-term outcome. METHODS: Multicenter retrospective analysis on all 46 consecutive patients with percutaneous (n = 43) or hybrid (n = 3) VSR closure in 2000-2020 with various nitinol wire mesh occluders. Medical records, hemodynamic data, procedure results, short- and mid-term follow-up were analyzed (4.8 ± 3.7 years, range: 0.1-15, available in 61.7% of patients). Of the patients, 34.8% underwent VSR closure in acute phase (<21 days after VSR occurrence), 17.4% underwent device closure due to significant residual shunt after previous VSR surgery. RESULTS: Success rate was 78.3%. More than moderate residual shunt, major complications, and early surgical reintervention affected 18.9%, 15.2% (including 2 intra-procedural deaths), and 21.7% of patients, respectively. Early mortality was 26.1% (13.9% in successful vs. 70% in unsuccessful closure; p < 0.001). Older age, need for intra-aortic balloon counterpulsation, severe complications, and procedural failure were identified as risk factors for early mortality. Among patients who survived the early period, the 5-year survival rate was 57.1%. NYHA class improved in 88.2% patients at the latest follow-up. CONCLUSIONS: Procedure of VSR device closure demonstrates an acceptable technical success rate; however, the incidence of severe complications and early mortality is notably high. Older patients in poor hemodynamic condition and those with unsuccessful occluder deployment are particularly at a higher risk of a fatal outcome. The prognosis after early survival is promising.

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.

Long-term outcome of rotational atherectomy according to burr-to-artery ratio and changes in coronary artery blood flow: Observational analysis.

BACKGROUND: Rotational atherectomy (RA) has been proven to be efficient for the treatment of calcified and diffuse coronary artery lesions. However, the optimal burr-to-artery ratio (BtAR) remains unidentified as well as an influence of change in blood flow on long-term outcome. Aim of our study was to examine the association between long-term outcome, and both BtAR and change in coronary flow during RA. METHODS: We conducted a retrospective study including patients who underwent RA. Two independent observers calculated BtAR, pre- and postprocedural corrected Thrombolysis in Myocardial Infarction (TIMI) frame count (cTFC) for artery treated with RA. The long-term outcome was defined as all-cause mortality. RESULTS: Receiver operating characteristic curve analysis of BtAR determined threshold of 0.6106 for all-cause mortality detection with sensitivity 50.0%, specificity 90.8%, and area under the curve 0.730 (p < 0.001). Kaplan-Meier survival analysis showed that the all-cause mortality rate in the group with the BtAR > 0.6106 is significantly higher compared to the patients with lower BtAR (hazard ratio [HR] 3.76, 95% confidence interval [CI] 1.51-9.32; p < 0.001). Kaplan-Meier survival analysis revealed that the all-cause mortality rate in the group with impairment in coronary flow was significantly higher compared to group with cTFC difference ≤ 0 after RA (HR 3.28, 95% CI 1.56-9.31; p = 0.02). CONCLUSIONS: Burr-to-artery ratio > 0.6106 is associated with worse prognosis of patients treated with RA. Patients showing post-RA impairment in blood flow in the target artery have worse prognosis.

Transcatheter Closure of Patent Ductus Arteriosus in Elderly Patients: Initial and One-Year Follow-Up Results-Do We Have the Proper Device?

OBJECTIVES: Patent ductus arteriosus (PDA) in elderly patients is an uncommon anomaly, and the duct itself is often calcified and fragile; therefore, transcatheter closure is more difficult. The aim is to analyse periprocedural and one-year follow-up results of transcatheter closure of PDA in such patients. Methods and results. Retrospective analysis of 33 elective patients aged ≥55 years (median 63; 56-85; 29 women), in whom PDA was closed percutaneously between 2002 and 2018 in two tertiary centres. All but three patients were symptomatic, with most in NYHA II (n = 14) and III (n = 11) class; pulmonary hypertension (n = 22), arterial hypertension (n = 22), duct calcifications (n = 17), atrial fibrillation (n = 15), significant mitral regurgitation (n = 5), and decompensated renal failure (n = 2) were observed. Different devices were applied depending on PDA morphology; nitinol wire mesh occluders with symmetrical articulating discs have been the most used in recent years (n = 11). Follow-up was conducted at an outpatient clinic (28/33 patients). The procedure was successful in all patients. There was one embolisation, followed by implantation of a larger device. No major complications were noted. A small residual shunt was present in echocardiography in one patient after one year. NYHA class improved in all but two patients (with multiple comorbidities). CONCLUSIONS: Transcatheter PDA closure in elderly patients is safe and efficient with a high complete closure rate and few complications. Amplatzer duct occluder type II is an attractive device in such patients.

Safety and efficacy of self-apposing Stentys drug-eluting stent in left main coronary artery PCI: Multicentre LM-STENTYS registry.

BACKGROUND: There is a paucity of data on left main (LM) percutaneous coronary intervention (PCI) therapy with dedicated DES platforms. The LM-STENTYS is a multicenter registry aimed at evaluating clinical outcome after PCI of LM performed with a self-apposing Stentys DES implantation. METHODS: The registry consists of 175 consecutive patients treated with Stentys DES implanted to LM. The primary endpoint was the composite of major adverse cardiac and cerebral events (MACCE) defined as cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and stroke assessed after 1 year. The secondary endpoint was stent thrombosis (ST) at 1 year. RESULTS: The median age was 69 years (IQR, 62-78 years). Acute coronary syndrome (ACS) was the presenting diagnosis in 117 (66.9%) patients [74 (63.2%) unstable angina, 31 (26.5%) NSTEMI, 12 (10.3%) STEMI] and stable angina (SA) was present in 58 (33.1%) patients. The median SYNTAX score was 23.0 (IQR, 18.7-32.2) in the SA group and 25.0 (IQR, 20.0-30.7) in the ACS group. During 1-year follow-up in the SA group two (3.4%) MACCE occurred, both of them were cardiac deaths. In ACS patients there were 19 (16.2%) MACCE [9 (7.7%) cardiac deaths, 11 (9.4%) MIs, 11(9.4%) TLR, 1(0.9%) stroke]. Altogether, three (1.7%) cases of acute ST were noted, all of them in ACS subset. CONCLUSION: LM PCI using self-apposing Stentys DES showed favorable clinical outcomes at 1-year in patients with SA. Events of ST in the ACS group warrant further research.

Percutaneous Left Atrial Appendage Closure With the Ultraseal Device: Insights From the Initial Multicenter Experience.

OBJECTIVES: This study sought to evaluate the feasibility, safety, and efficacy of the Ultraseal device for left atrial appendage closure (LAAC) (Cardia, Eagan, Minnesota) in patients with nonvalvular atrial fibrillation at high bleeding risk. BACKGROUND: The Ultraseal device is a novel bulb-and-sail designed LAAC device, with an articulating joint enabling conformability to heterogeneous angles and shapes of appendage anatomy. METHODS: This was a multicenter study including consecutive patients undergoing LAAC with the Ultraseal device at 15 Canadian and European sites. Periprocedural and follow-up events were systematically collected, and transesophageal echocardiography at 45 to 180 days post-procedure was routinely performed in all centers but 3. RESULTS: A total of 126 patients (mean age 75 ± 8 years; mean CHA2DS2-VASc score 5 ± 2; mean HAS-BLED score 4 ± 1) were included. The device was successfully implanted in 97% of patients. A major periprocedural adverse event occurred in 3 (2.4%) patients (clinically relevant pericardial effusion [n = 1], stroke [n = 1], device embolization [n = 1]). Ninety percent of patients were discharged on single or dual antiplatelet therapy. Follow-up transesophageal echocardiography was available in 89 (73%) patients, with no cases of large (>5 mm) residual leak and 5 (5.6%) cases of device-related thrombosis (all successfully treated with anticoagulation therapy). At a median follow-up of 6 (interquartile range: 3 to 10) months, the rates of stroke and transient ischemic attack were 0.8% and 0.8%, respectively, with no systemic emboli. None of the events occurred in patients with device-related thrombosis. CONCLUSIONS: In this initial multicenter experience, LAAC with the Ultraseal device was associated with a high implant success rate and a very low incidence of periprocedural complications. There were no late device-related clinical events and promising efficacy results were observed regarding thromboembolic prevention at midterm follow-up. Larger studies are further warranted to confirm the long-term safety and efficacy of this novel device.

[Left atrial appendage occlusion: consensus document of Association of Cardiovascular Interventions and Heart Rhythm Section of Polish Cardiac Society]. / Przezcewnikowe zamykanie uszka lewego przedsionka -stanowisko grupy ekspertów powolanej przez Asocjacje Interwencji Sercowo-Naczyniowych oraz Sekcje Rytmu Serca Polskiego Towarzystwa Kardiologicznego.

Left atrial appendage (LAA) occlusion devices have the potential to influence the clinical approach to stroke prevention in patients with atrial fibrillation. A number of percutaneous techniques have been proposed, including various intracardiac plugs and also external ligation. Several devices have been already used in Poland. One of them has been evaluated in randomised controlled trials compared with the current standard of care. Others are less well studied but quite commonly used in Eu-rope. It is anticipated that the use of LAA occlusion technologies in clinical practice will expand. This Consensus Document prepared jointly by Association of Cardiovascular Interventions (AISN) and Heart Rhythm Section (HRS) of Polish Cardiac Society seeks to highlight the critical issues surrounding LAA occlusion therapies and to facilitate the alignment of multiple interests, including those of primary care physicians, general cardiologists and procedural specialists (electrophysiologists and interventional cardiologists) but also other medical professionals. The article summarises current evidence and provides spe-cific recommendations on organisation and conduct of LAA therapy in patients with atrial fibrillation in Poland and defines also operator and institutional requirements fundamental to the establishment of successful LAA occlusion programmme.

Admission glucose and left ventricular systolic function in non-diabetic patients with acute myocardial infarction.

Carbohydrate metabolism disorder in patients hospitalized due to acute ST-segment elevation myocardial infarction (STEMI) is associated with poor outcome. The association is even stronger in non-diabetic patients compared to the diabetics. Poor outcome of patients with elevated parameters of carbohydrate metabolism may be associated with negative impact of these disorders on left ventricular (LV) function. The aim of the study was to determine the impact of admission glycemia on LV systolic function in acute phase and 6 months after myocardial infarction in STEMI patients treated with primary angioplasty, without carbohydrate disorders. The study group consisted of 52 patients (9 female, 43 male) aged 35-74 years, admitted to the Department of Cardiology and Internal Medicine, Collegium Medicum in Bydgoszcz, due to the first STEMI treated with primary coronary angioplasty with stent implantation, without diabetes in anamnesis and carbohydrate metabolism disorders diagnosed during hospitalization. Echocardiography was performed in all patients in acute phase and 6 months after MI. Plasma glucose were measured at hospital admission. In the subgroup with glycemia ≥7.1 mmol/l, in comparison to patients with glycemia <7.1 mmol/l, significantly lower ejection fraction (EF) was observed in acute phase of MI (44.4 ± 5.4 vs. 47.8 ± 6.3 %, p = 0.04) and trend to lower EF 6 months after MI [47.2 ± 6.5 vs. 50.3 ± 6.3 %, p = 0.08 (ns)]. Higher admission glycemia in patients with STEMI and without carbohydrate metabolism disturbances, may be a marker of poorer prognosis resulting from lower LV ejection fraction in the acute phase and in the long-term follow-up.

Associations between selected angiographic parameters and the number of CD34⁺ cells and plasma levels of vascular endothelial growth factor and angiogenin in patients with ST-segment elevation myocardial infarction.

INTRODUCTION: Left ventricular (LV) function and prognosis in patients after myocardial infarction are associated with some angiographic parameters. OBJECTIVES: The aim of the study was to assess the associations between the TIMI score in the infarct-related artery (IRA) before percutaneous coronary intervention (PCI), myocardial blush grade (MBG) following effective PCI, and the extent of collaterals measured using the Rentrop scale and plasma levels of vascular endothelial growth factor (VEGF) and angiogenin, number of CD34⁺ cells, as well as LV ejection fraction (LVEF) and wall motion score index (WMSI). PATIENTS AND METHODS: In 62 patients with the first ST-segment elevation myocardial infarction (STEMI) treated with PCI and bare metal stent implantation, plasma VEGF and angiogenin levels as well as the number of CD34⁺ cells were assessed before PCI, 24 hours after PCI, at discharge, and at 30 days following STEMI. LVEF and WMSI were evaluated by echocardiography at discharge and at 1 and 6 months after STEMI. RESULTS: Patients with TIMI 0-1 flow in the IRA before PCI (64.6% of the patients) had significantly higher troponin I and VEGF levels as well as a higher number of CD34⁺ cells than patients with TIMI 3 flow. Patients with TIMI 0-1 flow also had worse LV systolic function at 1 and 6 months following STEMI. Neither the MBG grade nor the Rentrop score showed associations with the mobilization of CD34⁺ cells, VEGF and angiogenin levels, and parameters of L V systolic function. CONCLUSIONS: Early patency of the IRA and lower myocardial necrosis seem to be more important for LV function assessed in patients 6 months after STEMI than mobilization of CD34⁺ cells and levels of angiogenic factors.

Meta-analysis of impact of different types and doses of statins on new-onset diabetes mellitus.

Recent reports indicate that statins are associated with an increased risk for new-onset diabetes mellitus (DM) compared with placebo and that this relation is dose dependent. The aim of this study was to perform a comprehensive network meta-analysis of randomized controlled trials (RCTs) investigating the impact of different types and doses of statins on new-onset DM. RCTs comparing different types and doses of statins with placebo were searched for using the MEDLINE, Embase, and Cochrane databases. A search of RCTs pertinent to this meta-analysis covering the period from November 1994 to October 2012 was conducted by 2 independent investigators using the MEDLINE, Cochrane, Google Scholar, and Embase databases as well as abstracts and presentations from major cardiovascular meetings. Seventeen RCTs reporting the incidence of new-onset DM during statin treatment and including a total of 113,394 patients were identified. The RCTs compared either a statin versus placebo or high-dose versus moderate-dose statin therapy. Among different statins, pravastatin 40 mg/day was associated with the lowest risk for new-onset DM compared with placebo (odds ratio 1.07, 95% credible interval 0.86 to 1.30). Conversely, rosuvastatin 20 mg/day was numerically associated with 25% increased risk for DM compared with placebo (odds ratio 1.25, 95% credible interval 0.82 to 1.90). The impact on DM appeared to be intermediate with atorvastatin 80 mg/day compared with placebo (odds ratio 1.15, 95% credible interval 0.90 to 1.50). These findings were replicated at moderate doses. In conclusion, different types and doses of statins show different potential to increase the incidence of DM.

Value of C-reactive protein in predicting left ventricular remodelling in patients with a first ST-segment elevation myocardial infarction.

OBJECTIVE: To assess the value of C-reactive protein (CRP) in predicting postinfarct left ventricular remodelling (LVR). METHODS: We measured in-hospital plasma CRP concentrations in patients with a first ST-segment elevation myocardial infarction (STEMI). RESULTS: LVR was present at 6 months in 27.8% of 198 patients. CRP concentration rose during the first 24 h, mainly in LVR group. The prevalence of LVR was higher in patients from the highest quartile of CRP concentrations at 24 h as compared to those from any other quartile (odds ratio (OR) 3.48, 95% confidence interval (95% CI) 1.76-6.88). Multivariate analysis identified CRP concentration at 24 h (OR for a 10 mg/L increase 1.29, 95% CI 1.04-1.60), B-type natriuretic peptide at discharge (OR for a 100 pg/mL increase 1.21, 95% CI 1.05-1.39), body mass index (OR for a 1 kg/m(2) increase 1.10, 95% CI 1.01-1.21), and left ventricular end-diastolic volume (OR for a 1 mL increase 0.98, 95% CI 0.96-0.99) as independent predictors of LVR. The ROC analysis revealed a limited discriminative value of CRP (area under the curve 0.61; 95% CI 0.54-0.68) in terms of LVR prediction. CONCLUSIONS: Measurement of CRP concentration at 24 h after admission possesses a significant but modest value in predicting LVR after a first STEMI.

Coronary artery aneurysm after implantation of an endothelial progenitor cell capturing stent.

The Genous™ stent coated with anti-CD34 antibodies has been designed to accelerate healing of the vessel by attracting circulating endothelial progenitor cells. Rapid restoration of a functional endothelial layer with a full coverage of the stent struts aims to minimise arterial injury after coronary stenting and to prevent thrombus formation and neointima proliferation. We report a case of a 56 year-old man who developed a coronary artery aneurysm after the implantation of a Genous™ stent due to an edge restenosis in sirolimus-eluting stent. We present diagnostics of our patient with the application of intravascular ultrasound and coronary computed tomography angiography, discuss his management, and hypothesise about the pathomechanism of aneurysm formation.

Occurrence and predictors of left ventricular systolic dysfunction at hospital discharge and in long-term follow-up after acute myocardial infarction treated with primary percutaneous coronary intervention.

BACKGROUND: Post-ST-segment elevation myocardial infarction (STEMI) left ventricular systolic dysfunction (LVSD) has been identified as an important marker of poor prognosis. AIM: To assess the prevalence and course of LVSD at hospital discharge and in long-term follow-up in STEMI patients treated with primary percutaneous coronary intervention (pPCI). METHODS: We enrolled 205 patients (157 male, 48 female) with a first STEMI. Echocardiography was performed before hospital discharge and 12 months after STEMI. Left ventricular systolic function (LVSF) parameters were assessed: left ventricular ejection fraction (LVEF), wall motion score index (WMSI), and average peak systolic mitral annular velocity (S') by tissue Doppler echocardiography (TDE). B-type natriuretic peptide plasma concentration was measured at admission (BNP(admission)) and at discharge (BNP(discharge)). RESULTS: We found moderate LVSD, both at hospital discharge and after 12 months. Significant global LVSD (LVEF ≤ 40%) was observed in 34% of patients at discharge, and 21% after 12 months (p 〈 0.001). Significant regional LVSD (WMSI ≥ 1.7) after 12 months was less frequent than at discharge (21% vs 33%; p 〈 0.001). More patients had significant longitudinal LVSD (S' ≤ 6.0 cm/s) after 12 months compared to discharge (28% vs 23%; p 〈 0.001). Severe global LVSD (LVEF ≤ 30%) was rare. Univariate logistic regression analysis revealed the predictors of significant global LVSD at 12 months after STEMI to be: anterior location of STEMI; pre-discharge echocardiographic parameters of LVSF and left ventricle size and mass; prepPCI angiographic indices; ratio of the difference of BNP(discharge) and BNPa(dmission) to BNP(admission) expressed as % (BNP(delta) %); time from onset of pain to balloon, and the use of abciximab. Multivariate logistic regression analysis found independent predictors of significant global LVSD at 12 months to be: BNP(delta) % and LVEF at discharge with optimal cut-off values of 728.2% for BNP(delta) % and 37% for LVEF. CONCLUSIONS: Patients with a first STEMI treated with pPCI present moderate LVSD, both at hospital discharge and after 12 months. In long-term follow-up, we found an improvement in global LVSF, and, albeit a smaller, improvement in regional LVSF. No improvement in longitudinal LVSF was observed. The increase of BNP during hospitalisation, and LVEF at discharge, are independent predictors of significant global LVSD at 12 months after a first STEMI treated with pPCI. Pre-discharge peak systolic mitral annular velocity obtained by TDE may be useful in predicting LVEF in long-term follow-up in this group of patients.

Usefulness of C-reactive protein as a marker of early post-infarct left ventricular systolic dysfunction.

OBJECTIVE: To assess the usefulness of in-hospital measurement of C-reactive protein (CRP) concentration in comparison to well-established risk factors as a marker of post-infarct left ventricular systolic dysfunction (LVSD) at discharge. MATERIALS AND METHODS: Two hundred and four consecutive patients with ST-segment-elevation myocardial infarction (STEMI) were prospectively enrolled into the study. CRP plasma concentrations were measured before reperfusion, 24 h after admission and at discharge with an ultra-sensitive latex immunoassay. RESULTS: CRP concentration increased significantly during the first 24 h of hospitalization (2.4 ± 1.9 vs. 15.7 ± 17.0 mg/L; p < 0.001) and persisted elevated at discharge (14.7 ± 14.7 mg/L), mainly in 57 patients with LVSD (2.4 ± 1.8 vs. 25.0 ± 23.4 mg/L; p < 0.001; CRP at discharge 21.9 ± 18.6 mg/L). The prevalence of LVSD was significantly increased across increasing tertiles of CRP concentration both at 24 h after admission (13.2 vs. 19.1 vs. 51.5 %; p < 0.0001) and at discharge (14.7 vs. 23.5 vs. 45.6 %; p < 0.0001). Multivariate analysis demonstrated CRP concentration at discharge to be an independent marker of early LVSD (odds ratio of 1.38 for a 10 mg/L increase, 95 % confidence interval 1.01-1.87; p < 0.04). CONCLUSION: Measurement of CRP plasma concentration at discharge may be useful as a marker of early LVSD in patients after a first STEMI.