Long-term bio-functional performance of a novel, self-positioning balloon expandable transcatheter biological aortic valve system in the ovine aortic banding model.

BACKGROUND: The aim of the study was to evaluate bio-functionality of a novel, proprietary balloon-expandable biological transcatheter aortic valve implantation (TAVI) system (InFlow, CardValve Consortium, Poland) in an ovine model of aortic banding. METHODS: Surgical ascending aorta banding was created in 21 sheep. Two weeks later, 18 biological valves were implanted within the model using 15-16 F InFlow TAVI systems and carotid cut-down approach. Follow-up transthoracic echocardiography was performed at 30, 90, and 180-day. At designated time, animals were euthanized and valves harvested for analysis. RESULTS: All sheep survived the banding procedure. There were 4 (22%) procedure related deaths within a 7-day period. During the observation an additional 2 sheep died. In one, the valve dislocated after the procedure - the animal was excluded. Two animals completed 30-day follow up, five 90-day follow-up and four terminal follow-up of 180 days. Valves examined via transesophageal echocardiography showed proper hemodynamic parameters without evidence of structural valve deterioration. The maximum and average flow gradients at 180 days were 31.4 (23.3-37.7) and 17.5 (13.1-20.2) mmHg, respectively. There was one case of moderate insufficiency and no case of perivalvular leaks. By histopathology, there were no inflammation, thrombosis, nor calcifications in any tested valves at long-term follow-up. Neointimal coverage of stent struts increased with time from basal part in "early" groups to nearly 3/4 of stent length in the 180-day group. The pannus tissue showed maturation that increased with time with no stenotic "collar" visible in orthotopically implanted valves. CONCLUSIONS: The study showed good hemodynamic performance, durability and biocompatibility of the novel biological THV.

Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable-polymer coronary stent - five-year results of the TARGET All Comers randomised clinical trial.

BACKGROUND: In the prospective, multicentre, randomised TARGET All Comers study, percutaneous coronary intervention (PCI) with the FIREHAWK biodegradable-polymer sirolimus-eluting stent (BP-SES) was non-inferior to the durable-polymer everolimus-eluting stent (DP-EES) for the primary endpoint of target lesion failure (TLF) at 12 months. AIMS: We aimed to report the final study outcomes at 5 years. METHODS: Patients referred for PCI were randomised to receive either a BP-SES or DP-EES in a 1:1 ratio in 10 European countries. Randomisation was stratified by centre and ST-elevation myocardial infarction (STEMI) presentation, and clinical follow-up extended to 5 years. The primary endpoint was TLF (composite of cardiac death, target vessel myocardial infarction [MI], or ischaemia-driven target lesion revascularisation). Secondary endpoints included patient-oriented composite events (POCE; composite of all-cause death, all MI, or any revascularisation and its components). RESULTS: From December 2015 to October 2016, 1,653 patients were randomly assigned to the BP-SES or DP-EES groups, of which 93.8% completed 5-year clinical follow-up or were deceased. At 5 years, TLF occurred in 17.1% of the BP-SES group and in 16.3% of the DP-EES group (p=0.68). POCE occurred in 34.0% of the BP-SES group and 32.7% of the DP-EES group (p=0.58). Revascularisation was the most common POCE, occurring in 19.3% of patients receiving BP-SES and 19.2% receiving DP-EES, of which less than one-third was ischaemia-driven target lesion-related. In the landmark analysis, there were no differences in the rates of TLF and POCE between groups from 1 to 5 years, and these results were consistent across all subgroups. CONCLUSIONS: In an all-comers population requiring stent implantation for myocardial ischaemia, the BP-SES was non-inferior to the DP-EES for the primary endpoint of TLF at 12 months, and results were sustained at 5 years, confirming the long-term safety and efficacy of the FIREHAWK BP-SES.

Hemostatic disorders in patients with infective endocarditis undergoing urgent surgical valve replacement - Rethinking current beliefs.

BACKGROUND: Although infective endocarditis (IE) represents a unique model of thrombo-inflammatory disease, the most frequent early complications of surgical valve replacement (SVR) in IE population are coagulopathy and bleeding. The hemostatic capacity and procedure-related coagulation disorders of IE patients undergoing SVR are unknown. The aims of this study were to test periprocedural hemostasis in IE patients undergoing urgent SVR, and to assess the association between disorders of hemostasis and early bleeding as well as with thromboembolic events. METHODS: A prospective, two-center, hypothesis generating, observational study was performed between Dec 2017 and Jan 2020. Periprocedural hemostasis of IE patients was assessed using Total Thrombus-formation Analysis System (T-TAS Plus) within 24 h before and 72 h post SVR. RESULTS: Overall, 25 patients with active IE undergoing urgent SVR were tested. Hemostatic capacity of IE patients was significantly impaired pre-SVR as well as post-SVR compared to normal values, in most aspects of T-TAS assays under high and low shear forces, including prolonged activation of coagulation (T10), final clot formation (OT) and clot strength (AUC30). Post-SVR T-TAS results were significantly associated with early bleeding and with red blood cell, platelet, and fresh frozen plasma administration. No association with thrombo-embolic events was found. CONCLUSIONS: Patients with active IE undergoing urgent SVR have significantly reduced hemostatic capacity before and after SVR. Hemostatic insufficiency post-SVR is related to bleeding and blood products transfusion. T-TAS may be helpful in assessment of periprocedural hemostasis in patients with IE undergoing SVR.

Long-term outcomes of the Coordinated Care Program in Patients after Myocardial Infarction (KOS-MI).

BACKGROUND: The Coordinated Care in Myocardial Infarction Program (KOS-MI) was introduced to improve prognosis for patients after myocardial infarction (MI). The program includes complete revascularization followed by unrestricted access to rehabilitation, electrotherapy and cardiac care. AIM: The aim of this study was to assess major adverse cardiac and cerebrovascular events (MACCE) of patients enrolled in the KOS-MI at 3-year follow-up. METHODS: This is a retrospective, multicenter registry of patients treated for MI. Study group (KOS-MI) of 963 patients was compared to the control group (standard of care) of 1009 patients. At 3-year follow-up MACCE including death, MI, stroke and repeated revascularization were reported. Additionally, hospitalization due to heart failure (HF) was analyzed. Propensity score matching (PSM) was utilized for group baseline characteristics adjustment. RESULTS: Patients in the KOS-MI group were younger (65 vs. 68; P < 0.001), mostly men (70% vs. 62.9%; P < 0.001), admitted with ST-elevation myocardial infarction (STEMI) (44.6% vs. 36.2%; P < 0.001). Patients in the control group had more comorbidities and were admitted more often with non ST-elevation myocardial infarction (63.8% vs. 55.4%; P < 0.001) and acute HF (5.1% vs. 2.7%; P = 0.007). Following PSM 530 well matched pairs were selected. At three years (92.3% follow-up completeness), the relative risk reduction was: 25% in MACCE (P = 0.008), 38% in mortality (P = 0.008), 29% in repeated revascularization(P = 0.04) and 28% (P = 0.0496) in hospitalization for HF in the KOS-MI group. CONCLUSIONS: The combination of contemporary invasive techniques, complete revascularization, cardiac rehabilitation and ambulatory care included in the KOS-MI Program improves long-term prognosis of patients after MI up to 3-year follow-up.

Impact of smoking on outcomes in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention.

INTRODUCTION: Smoking is a well­established risk factor for cardiovascular diseases. However, in patients with ST­segment elevation myocardial infarction (STEMI), smoking has been associated with better clinical outcomes; this phenomenon became known as the "smoker's paradox." OBJECTIVES: The aim of this study was to evaluate the association between smoking and clinical outcomes in STEMI patients treated with primary percutaneous coronary intervention (PCI), using 3 large national registries. PATIENTS AND METHODS: We retrospectively analyzed the data of 82 235 hospitalized STEMI patients treated with primary PCI. Among the analyzed population, 30 966 patients (37.96%) were smokers, and 51 269 (62.36%) were nonsmokers. We evaluated the baseline characteristics, pharmacotherapy, clinical outcomes, and readmission causes in a 36­month follow­up. RESULTS: The smokers were significantly younger (median [interquartile range] age, 58 [52-64] vs 68 [59-77] years; P <0.001) than the nonsmokers, and there were more men in this group. The patients who smoked were less likely to have traditional risk factors, as compared with the nonsmokers. In the unadjusted analysis, in­hospital and 36­month mortality and rehospitalization rates were lower in the smokers group. However, after adjustment for baseline characteristics that differed between the 2 groups, the multivariable analysis showed that tobacco use was one of the independent risk factors for 36­month mortality (hazard ratio, 1.11; 95% CI, 1.06-1.18; P <0.001). CONCLUSIONS: In the present large­scale, registry­based analysis, the observed lower 36­month crude rates of adverse events among the smokers, as compared with the nonsmokers, might be partially explained by a significantly lower burden of traditional risk factors and younger age of the smokers. After accounting for age and other baseline differences, smoking was found to be one of the independent risk factors for 36­month mortality.

Safety and feasibility of minimally invasive coronary artery bypass surgery early after drug-eluting stent implantation due to acute coronary syndrome.

BACKGROUND: The evidence on performing minimally invasive coronary artery surgery early after drug-eluting stent (DES) implantation due to acute coronary syndrome (ACS) is limited. AIM: The study aimed to determine the safety and feasibility of this approach. METHODS: This registry included 115 (78% male) patients treated from 2013 to 2018, who underwent non-left anterior descending (LAD) percutaneous coronary intervention (PCI) due to ACS with contemporary DES implantation (39% diagnosed with myocardial infarction at baseline), followed by endoscopic atraumatic coronary artery bypass (EACAB) surgery within 180 days, after temporary P2Y12 inhibitor discontinuation. Primary composite endpoint of MACCE (major adverse cardiac and cerebrovascular events), defined as death, myocardial infarction (MI), cerebrovascular incident, and repeat revascularization was evaluated in long-term follow-up. The follow-up was collected via a telephone survey and in line with National Registry for Cardiac Surgery Procedures. RESULTS: The median (interquartile range [IQR]) time interval separating both procedures was 100.0 (62.0-136.0) days. Median (IQR) follow-up duration was 1338.5 (753.0-2093.0) days and was completed for all patients with regard to mortality. Eight patients (7%) died; 2 (1.7%) had a stroke; 6 (5.2%) suffered from MI, and 12 (10.4%) required repeat revascularization. Overall, the incidence of MACCE was 20 (17.4%). CONCLUSIONS: EACAB is a safe and feasible method of LAD revascularization in patients who received DES for ACS within 180 days before surgery despite early dual antiplatelet therapy discontinuation. The adverse event rate is low and acceptable.

6-Month Evaluation of a Transcatheter Aortic Valve (Myval) in a Novel Ovine, Supra-Aortic Banding Model.

The aim of the study was to evaluate a balloon expandable transcatheter heart valve (THV) system (Myval) at 6-month follow-up in ovine banding model. Eleven THV systems were implanted via carotid approach. There were 2 procedure-related deaths and 2 premature deaths. At 6 months all valves that completed follow-up (n = 7) were functional, with no significant regurgitation, calcification, thrombi, or vegetation. Mean pressure gradient was 21.9 ± 11 mm Hg, maximum velocity = 3.3 ± 1 m/s, and ejection fraction was 53.3 ± 6%. Myval THV showed optimal hemodynamic performance and biocompatibility.

Temporal, biomechanical evaluation of a novel, transcatheter polymeric aortic valve in ovine aortic banding model.

Objectives: The aim of the study is to evaluate the functionality, durability, and temporal biocompatibility of a novel, balloon-expandable polymeric transcatheter heart valve (ATHV) system (InFlow, CardValve Consortium, Poland). Along with expanding TAVI indications, the demand for new transcatheter valves is increasing. Methods: A surgical ascending aortic banding model was created in 20 sheep. Two weeks later, 16 sheep were implanted with ATHV systems (15-16F). Three animals were euthanized after a 30-day follow-up, four animals after a 90-day follow-up, and six animals after a 180-day follow-up. A follow-up transthoracic echocardiography (TTE) was performed. Results: There was one procedure-related (6,25%) and two model-related deaths (12,5%; banding site calcification with subsequent infection originating externally from banding). TTE revealed the flow gradients (max/average) of 30,75/17,91; 32,57/19,21; and 21,34/10,63 mmHg at 30, 90, and 180 days, respectively. There were two cases of low-degree regurgitation after 180 days with no perivalvular leak observed. Histopathological analysis showed no valve degeneration at terminal follow-up with optimal healing. Small thrombi were present at the aortic wall adjacent to the base of the leaflets, and between the aortic wall and the stent in most of the valves; however, leaflets remained free from thrombi in all cases. Scanty calcifications of leaflets were reported in three animals evaluated 180 days after implantation. Conclusion: This preclinical study in the aortic banding model showed good hemodynamic performance, durability, and biocompatibility of the novel ATHV. Furthermore, regulatory studies with longer follow-ups are warranted.

Multivessel Intervention in Myocardial Infarction with Cardiogenic Shock: CULPRIT-SHOCK Trial Outcomes in the PL-ACS Registry.

BACKGROUND: The aim of the study was a comparison of culprit-lesion-only (CL-PCI) with the multivessel percutaneous coronary intervention (MV-PCI) in terms of 30-day and 12-month mortality in a national registry. METHODS: Patients from the PL-ACS registry with MI and CS were analyzed. Patients meeting the criteria of the CULPRIT-SHOCK trial were divided into two groups: CL-PCI and MV-PCI groups. RESULTS: Of the 3265 patients in the PL-ACS registry with MI complicated by CS, the criteria of the CULPRIT-SHOCK trial were met by 2084 patients (63.8%). The CL-PCI was performed in 883 patients, and MV-PCI was performed in 1045 patients. After the propensity score matching analysis, 617 well-matched pairs were obtained. In a 30-day follow-up, death from any cause occurred in 49.3% in the CL-PCI group and 57.0% in the MV-PCI group (RR 0.86, 95% CI 0.58-0.92, p = 0.0081). After 12 months, the rate of mortality was 62.5% in the CL-PCI group and 68.0% in the MV-PCI group (RR 0.92, 95% CI 0.84-1.01, p = 0.066). CONCLUSIONS: The results confirm the validity of CULPRIT-SHOCK findings in a national registry and current guideline-recommended strategy of revascularization limited to the infarct-related artery.

Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial.

The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention. At 6 months, the LLL was 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm; psup < 0.01). Binary restenosis occurred in 23% vs 52% of patients (p = 0.02). At 3 years, the prevalence of SAE was significantly lower in the mcPCB group (33.3 vs 63.3%; p = 0.02), which mainly resulted from a twofold reduction in target vessel revascularization rate (28.6 vs 59.3%; p = 0.02). The difference in mortality was nonsignificant (7.4 vs 14.3%; p = 0.42). Patients with mcPCB were less symptomatic and less likely to adhere to secondary prevention measures. In this pivotal trial, a novel mcPCB proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality. ClinicalTrials.gov Identifier: NCT02145065.

Long­term outcomes of transcatheter self-expanding aortic valve implantations in inoperable and high surgical-risk patients with severe aortic stenosis: a single-center single-valve registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is being increasingly used in patients with longer life expectancy. Data on long­term outcomes are still limited. AIMS: The aim of the study was to assess the clinical outcomes of patients treated with TAVI and identify baseline and procedure­related factors influencing long­term survival. METHODS: Symptomatic patients with critical aortic stenosis who were inoperable or had high surgical risk were qualified for TAVI. Between August 2012 and December 2017, 248 consecutive patients treated with self ­expanding Medtronic valve implantation at American Heart of Poland in Bielsko­Biala were prospectively enrolled. Patients were followed for 30 days after the procedure and subsequently annually. All events were classified according to the Valve Academic Research Consortium­2 (VARC­2) criteria and assessed. Survival was compared between the subgroups defined by the EuroSCORE II (European System for Cardiac Operative Risk Evaluation II) and with matched representatives from the general population. RESULTS: The median (interquartile range) follow­up was 3.4 (2.5-4.6) years, and the longest follow­up lasted 7.8 years. A total of 92 patients (37.1%) died during the follow­up. The Kaplan-Meier estimates for cumulative mortality at 1, 3, 5, and 7 years were: 11.3%, 26.8%, 42.1%, and 60.6%. Patients with EuroSCORE II greater than 6% experienced worse survival compared with those with EuroSCORE II 6% or less (P = 0.008). Patients with EuroSCORE II 6% or less had similar survival to the general population. Male sex, baseline eGFR of less than 50 ml/min/1.73 m2, chronic obstructive pulmonary disease, moderate / severe paravalvular leak, absence of postdilatation, major vascular complication, and stroke at 30 days were independently associated with long­term mortality. CONCLUSIONS: TAVI with a self­expanding Medtronic valve implantation according to a consistent protocol was associated with favorable outcomes. Patients with lower EuroSCORE II scores had the same prognosis as the actuarial survival of the general population.

Short and long-term results of endoscopic atraumatic coronary artery off-pump bypass grafting in patients with left anterior descending artery stenosis.

BACKGROUND: To perform a retrospective analysis of patients who underwent endoscopic atraumatic coronary artery off-pump bypass grafting (EACAB) in a single center over a period of 11 years. METHODS: Data was acquired from the hospital registry and patient medical records. In order to determine changes in clinical profile, patients were subdivided into three groups regarding year of surgery: 1998-2002 (group 1), 2003-2005 (group 2), 2006-2009 (group 3). In-hospital analysis up to 30 days and long-term observation were conducted. RESULTS: The study cohort consisted of 714 patients (581 male). Procedural success accounted for 99% of all patients. No mortality was observed up to 30 days. Complications in the early period included pleural effusion (7.6%), cardiac arrhythmias (3.6%), bleeding related revision (2.7%) and wound infection (1.6%). Mean follow-up was 6 years (2132 ± 1313 days; median: 1918.5). Nineteen (2.7%) patients died, of which 52.6% (10 patients) were due to heart related conditions. Overall frequency of major adverse cerebral and cardiovascular events (MACCE) was 10.8% (77 patients). The Kaplan-Meyer analysis defined survival rate and event-free survival in long-term observation of 96.1% and 85.3%, respectively. Ejection fraction (EF) < 50% was the only independent factor of mortality (OR: 3.35). Regarding cumulative MACCE, older age (OR: 1.72), lower EF (OR: 3.03), the history of percutaneous coronary intervention (OR: 2.13) and higher New York Heart Association class (OR: 2.63) influenced the incidence rate. CONCLUSIONS: The presented short and very long-term results confirm that EACAB is an efficient alternative for patients requiring revascularization of the left anterior descending artery. The elimination of cardiopulmonary bypass significantly reduces the number of complications.

Neointimal hyperplasia of ultra-thin stents with microcrystalline sirolimus or durable polymer everolimus-eluting stents: 6- and 24-month results of the DESSOLVE III OCT study.

AIMS: The DESSOLVE III OCT substudy aimed to compare serially neointimal hyperplasia volume obstruction (%VO) between the thin-strut MiStent with early polymer elimination and nine-month sustained drug release from microcrystalline sirolimus and the durable polymer-coated everolimus-eluting XIENCE stent at six and 24 months after implantation. METHODS AND RESULTS: The efficacy endpoint was %VO, calculated as abluminal neointimal volume/stent volume. Thirty-six patients (MiStent 16 patients, 16 lesions; XIENCE 20 patients, 22 lesions) underwent serial OCT evaluation at both six and 24 months. At six months, mean abluminal %VO was significantly lower in the MiStent group than in the XIENCE group (14.54±3.70% vs 19.11±6.70%; p=0.011), whereas the difference in %VO between the two groups decreased at 24 months (20.88±5.72% vs 23.50±7.33%; p=0.24). There was no significant difference in percentage malapposed struts and percentage uncovered struts between the two groups at both time points. CONCLUSIONS: In the serial comparative OCT analysis of the MiStent versus the XIENCE, the MiStent showed a more favourable efficacy for preventing neointimal formation with comparable strut tissue coverage, as compared with the XIENCE at six months, but this difference in %VO decreased at 24 months so that the difference in neointima at 24 months was no longer significant.

Antithrombotic regimens for percutaneous coronary intervention of the left main coronary artery: The EXCEL trial.

OBJECTIVES: We compared the effect of bivalirudin or heparin and use or nonuse of glycoprotein IIb/IIIa inhibitors (GPI) on the outcome of left main coronary artery (LMCA) percutaneous coronary intervention (PCI) in the randomized EXCEL trial. BACKGROUND: The optimal antithrombotic regimen to support PCI of the LMCA remains controversial because of low representation of this subset in clinical trials. METHODS: The PCI cohort (n = 928) in EXCEL was divided according to bivalirudin versus heparin antithrombin treatment and compared for the primary composite endpoint of death, myocardial infarction (MI), or stroke at 30 days and 5 years. RESULTS: Bivalirudin was used in 319 patients (34.4%). The composite endpoint at 30 days occurred in 7.2% versus 3.8% bivalirudin and heparin patients, respectively, p = .02; at 5 years, the composite endpoint occurred in 26.3% versus 19.9% bivalirudin and heparin patients, respectively, p = .02. Major bleeding was more frequent in bivalirudin patients (4.1% versus 1.3%, p = .008). There were no differences in stent thrombosis between the groups. Bivalirudin use was an independent predictor of the 30-day composite endpoint (OR 2.88, 95% CI 1.28-6.48, p = .01) but not of the 5-year composite endpoint (OR 1.30, 95% CI 0.84-2.02, p = .23). GPI use was infrequent (n = 67, 7.2%) and was not associated with adverse outcomes. CONCLUSION: Among patients undergoing LMCA PCI in the EXCEL trial, procedural use of bivalirudin was associated with greater rates of periprocedural MI and the 30-day composite endpoint without reducing bleeding complications. Five-year outcomes were similar. GPIs were used infrequently and were not associated with clinical outcomes.

Nanospheres encapsulated everolimus delivery into arterial wall-the tissue pharmacokinetics and vascular response experimental study.

OBJECTIVE: This study aimed to evaluate the pharmacokinetic profile and tissue effects of everolimus delivered into arterial wall using biodegradable nanospheres. BACKGROUND: Delivery of everolimus into the arterial wall is challenging due to its low-lipophilic profile. METHODS: A pharmacokinetic study included 28 porcine coronary arterial segments initially injured with balloon angioplasty followed by the local delivery of everolimus encapsulated in nanospheres (EEN) via injection through a microporous delivery catheter. The animals were sacrificed at 1 hour, 1,7,28, and 90-day follow-up. In the tissue effects study 16 coronary bare metal stent (BMS) were implanted following EEN delivery, 15 BMS following nanospheres delivery without the drug (reference group) and 16 implanted BMS served as a control. Angiographic and histology follow-up was scheduled at 28 and 90-day. RESULTS: The study showed high-everolimus concentrations in arterial tissue early after nanoparticles delivery followed by its gradual decrease to 1.15 ± 0.40 ng/mg at 90 days. Histology analysis showed favorable biocompatibility and healing profile with comparable area stenosis between groups at both time-points. CONCLUSIONS: The present study demonstrates for the first time the safety, biocompatibility, and long-term retention of everolimus in arterial tissue after single local delivery of biodegradable nanospheres.

Clinical Characteristics, Treatments, and Outcomes of Patients with Myocardial Infarction with Non-Obstructive Coronary Arteries (MINOCA): Results from a Multicenter National Registry.

BACKGROUND: Diagnosis of myocardial infarction with non-obstructive coronary arteries (MINOCA) requires both clinical evidence of acute myocardial infarction (AMI) and demonstration of non-obstructive coronary arteries using angiography. We compared the clinical features, treatments, and three-year outcomes in patients with MINOCA and myocardial infarction with obstructive coronary artery disease (MI-CAD). METHODS: We retrospectively analyzed data for 205,606 hospitalized patients with AMI. MINOCA was indicated as a working diagnosis in 6063 patients (2.94% of all AMI patients). For the control group we included 160,886 patients with MI-CAD. We evaluated the baseline characteristics, medication management options, outcomes, and readmission causes at 36 months follow-up. RESULTS: Patients in the MINOCA group were younger. Females constituted a greater proportion of patients in the MINOCA group when compared to MI-CAD patients. STEMI during admission was diagnosed less frequently in the MINOCA group when compared to the MI-CAD group. All-cause mortality at 12 months was higher in the MINOCA group (10.94% vs. 9.54%, p < 0.001). At 36 months, there was no difference in the all-cause mortality rates (MINOCA 16.18% vs. MI-CAD 14.93%, p = 0.081). All-cause readmission rates were lower in the MINOCA group when compared to the MI-CAD group at both 12 months (45.19% vs. 54.33%, p < 0.001) and 36 months follow-up (56.42% vs. 66.66%, p < 0.001). CONCLUSIONS: This is the first description of the clinical features, treatments, and three-year outcomes in a large population of Polish patients. The main finding of this study was a relatively low rate of MINOCA, with high rates of adverse events both at 12 and 36 months follow-up.

Influence of heart rate on FFR measurements: An experimental and clinical validation study.

BACKGROUND: Functional lesion assessment in stable coronary disease is considered the gold standard. The result of fractional flow reserve (FFR) in stable coronary disease is often a decision-maker for patient qualification. Taking into account the paramount position of FFR, it is crucial to acknowledge and reduce all potential bias. AIMS: In the present study, we quantified the influence of elevated HR on FFR results using a preclinical model and then validated the results in a clinical setting. METHODS AND RESULTS: The relationship between FFR and HR was first explored experimentally in a porcine model. A clinical validation study was conducted in patients with isolated moderate lesions in the left anterior descending artery (LAD) or right coronary artery (RCA). In both the experimental and clinical arms, FFR was measured at resting HR and with pacing at 100, 130, 160, and 180 (for pigs) beats per minute. In the porcine model and in the clinical settings, a significant correlation between FFR and HR was confirmed in the LAD (r = 0.89, p < .0001; r = 0.53, p = .00002), but not in the RCA (r = -0.19, p = .5; r = 0.14, p = .3). Post hoc analyses revealed that the FFR values in the LAD at 130/min and above tended to be significantly different from the baseline HR. CONCLUSIONS: The results of this study indicate that in an experimental setting, tachycardia might be responsible for an overestimation of FFR results in LAD lesions.

Long term outcomes in diabetic patients treated with atherectomy for peripheral artery disease.

BACKGROUND: The prevalence of diabetes has increased significantly in well-developed countries during the last decade and it continues to grow. Diabetes increases the risk of restenosis in patients treated percutaneously for peripheral artery disease. The present study sought to compare outcomes of atherectomy treatment in diabetic (DM) vs. non-diabetic (nDM) patients suffering from peripheral artery disease. METHOD: Between 2008 and 2012, 204 revascularization atherectomy procedures were performed on arteries of the lower extremities. The endpoints included target lesion revascularization (TLR), amputation and death. The type of atherectomy (excisional-soft plaque, orbital-calcified plaque, with active aspiration - with a thrombus) was left to operator discretion. RESULTS: This study contains 132 DM (66% male, age 68 ± 11.2 years) and 72 nDM (63% male, age 75 ± 11.3 years) subjects. DM were younger but had a higher prevalence of coronary artery disease (DM: 91% vs. nDM: 62%, p < 0.0001) and end-stage renal disease (DM: 22% vs. nDM: 2.5%, p < 0.0001). There were no differences in critical limb ischemia between the groups (DM: 21% vs. nDM: 12%, p = = 0.13). Mean time of follow-up was 384 and 411 days in DM and nDM, respectively (p = 0.43). There were no significant differences in TLR (DM: 15.2% vs. nDM: 22.2%, p = 0.249), amputations (DM: 3.0% vs. nDM: 1.5%, p = NS) or death rates (DM: 2.2% vs. nDM: 2.7%, p = NS). Kaplan-Mayer analysis showed no significant differences between the groups in the time to TLR, amputation or death. CONCLUSIONS: Plaque modification with adjusted atherectomy appears to have similar outcomes in diabetic as well as in non-diabetic patients. Nonetheless, a randomized study would be warranted to confirm the findings of the current study.

Impact of air pollution on hospital patients admitted with ST- and non-ST-segment elevation myocardial infarction in heavily polluted cities within the European Union.

BACKGROUND: Air pollution triggered diseases have become a leading health problem worldwide. The main adverse effects of air pollutants on human health are related to the cardiovascular system and particularly show an increasing prevalence of myocardial infarct and stroke. The aim of the study was to evaluate the influence of main air pollutants on non-ST-segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI) admissions to local interventional cardiology centers. METHODS: Between 2014 and 2015, a multicenter registry of 1957 patients with acute myocardial infarction (STEMI, NSTEMI) admitted to interventional cardiology departments in three Polish cities were under investigation. The air pollution (PM2.5, PM10, NO2, SO2, O3) and weather conditions (temperature, barometric pressure, humidity) data for each city were collected as daily averages. The case-crossover design and conditional logistic regression were used to explore the association between acute myocardial infarctions and short-term air pollution exposure. RESULTS: Occurrence of NSTEMI on the day of air pollution was triggered by PM2.5 (OR = 1.099, p = 0.01) and PM10 (OR = 1.078, p = 0.03). On the following day after the air pollution was recorded, NSTEMI was induced by: PM2.5 (OR = 1.093, p = 0.025), PM10 (OR = 1.077, p = 0.025) and SO2 (OR = 1.522, p = 0.009). For STEMI, events that occurred on the day in which air pollution was triggered by: PM2.5 (OR = 1.197, p < 0.001), PM10 (OR = 1.163, p < 0.001), SO2 (OR = 1.670, p = 0.001) and NO2 (OR = 1.287, p = 0.011). On the following day after air pollution was recorded, STEMI was induced by: PM2.5 (OR = 1.172, p < 0.001), PM10 (OR = 1.131, p = 0.001), SO2 (OR = 1.550, p = 0.005) and NO2 (OR = 1.265, p = 0.02). None of the weather conditions indicated were statistically significant for acute myocardial infarction occurrence. CONCLUSIONS: The most important pollutants triggering acute myocardial infarction occurrence in the population of southern Poland, both on the day of air pollution and the following day are particulate matters (PM2.5, PM10) and gaseous pollutants including NO2 and SO2. These pollutants should be regarded as modifiable risk factors and thus, their reduction is a priority in order to decrease total morbidity and mortality in Poland.

Ticagrelor monotherapy beyond one month after PCI in ACS or stable CAD in elderly patients: a pre-specified analysis of the GLOBAL LEADERS trial.

AIMS: Antiplatelet treatment in the elderly post percutaneous coronary interventions (PCI) remains a complex issue. Here we report the results of the pre-specified subgroup analysis of the GLOBAL LEADERS trial evaluating the long-term safety and cardiovascular efficacy of ticagrelor monotherapy among patients categorised according to the pre-specified cut-off value of 75 years of age. METHODS AND RESULTS: This was a pre-specified analysis of the randomised GLOBAL LEADERS trial (n=15,991), comparing 23-month ticagrelor monotherapy (after one month of DAPT) with the reference treatment (12-month DAPT followed by 12 months of aspirin). Among elderly patients (>75 years; n=2,565), the primary endpoint (two-year all-cause mortality or new Q-wave core lab-adjudicated myocardial infarction [MI]) occurred in 7.2% and 9.4% of patients in the ticagrelor monotherapy and the reference group, respectively (hazard ratio [HR] 0.75, 95% confidence interval [CI]: 0.58-0.99, p=0.041; pint=0.23); BARC-defined bleeding type 3/5 occurred in 5.2% and 4.1%, respectively (HR 1.29, 95% CI: 0.89-1.86; p=0.180; pint=0.06). The elderly with stable CAD had a higher rate of BARC 3/5 type bleeding (HR 2.05, 95% CI: 1.18-3.55) with ticagrelor monotherapy versus the reference treatment (pint=0.02). Elderly patients had a lower rate of definite or probable stent thrombosis (ST) with ticagrelor monotherapy (0.4% vs 1.4%, p=0.015, pint=0.01), compared with the reference group. CONCLUSIONS: In this pre-specified, exploratory analysis of the overall neutral trial, there was no differential treatment effect of ticagrelor monotherapy (after one-month dual therapy with aspirin) found in elderly patients undergoing PCI with respect to the rate of the primary endpoint of all-cause death or new Q-wave MI. The lower rate of ST in the elderly with ticagrelor monotherapy is hypothesis-generating. ClinicalTrials.gov identifier: NCT01813435.