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.

Routine Coronary Angiography is Still the Key Test for Patients Eligible for Lung Transplantation Also for Those With No Symptoms and With High Risk of Coronary Artery Disease.

BACKGROUND: Coronary artery disease (CAD) has a considerable morbidity and mortality effect on the outcomes of a lung transplant. Currently, coronary angiography is performed as part of the pretransplant evaluation process. Unfortunately, there are no clear guidelines about performing cardiac angiography in lung transplant candidates. BACKGROUND: The aim of our work is to find a correlation between cardiovascular risk and coronary arterial status to optimize the selection of patients for coronary angiography prior transplantation. METHODS: We retrospectively analyzed 48 patients in whom coronary angiography and cardiac catheterization was performed during assessment for bilateral lung transplantation at the Medical University of Gdansk from 2018 to 2021. The coronary artery disease status was classified into 2 categories: without any stenosis and with stenosis. For each patient, the 10-year cardiovascular risk was estimated by using a Systematic COronary Risk Evaluation calculator modified for the Polish population. RESULTS: Coronary stenosis was detected in 15 patients during angiography (31%). The group with coronary stenosis had a median SCORE risk of 8%, which is considered as high risk, and in patients without stenosis it was 5%, which is also considered a high risk. Median mean pulmonary artery pressure in patients with stenosis was the same as that in patients without stenosis (23 mm Hg). CONCLUSIONS: CAD among lung transplant candidates cannot be predicted by risk factors, so coronary angiography is very important as a part of the evaluation process. Because pulmonary hypertension has a big impact on surveillance after transplantation, performing heart catheterization during the qualification process is crucial.

Incidence, clinical correlates, timing, and consequences of acute thrombus formation in patients undergoing the MitraClip procedure.

BACKGROUND: Despite adequate heparinization, formation of fresh intracardiac thrombi during the MitraClip procedure was reported. AIMS: We aimed to evaluate the incidence and clinical consequences of intracardiac thrombus formation during the MitraClip device implantation. METHODS: Clinical data and transesophageal echocardiography findings obtained during MitraClip procedures in 100 consecutive patients (81 men; mean [SD] age, 67.8 [8.3] years) were reviewed. In all patients, a heparin bolus was given immediately after a successful transseptal puncture, and the activated clotting time above 250 seconds was maintained throughout the procedure. RESULTS: Thrombus formation was documented in 9 patients (9%). In 6 patients, thrombi formed on a transseptal needle/sheath (2 attached to the sheath in the right atrium and 4 on the sheath immediately after the puncture in the left atrium), and in 3 patients, on the MitraClip device in the left atrium (2 on a steerable guiding catheter and 1 on the clip delivery system). Overall, 6 thrombi (67%) formed prior to and 3 (33%) after heparin administration. All thrombi were transient and disappeared within minutes. No periprocedural ischemic stroke, transient ischemic attack, or other embolic complications were reported. Clinical characteristics were similar in patients with and without thrombi, except for lower left ventricular ejection fraction (LVEF; mean [SD], 23% [10%] and 30% [10%], respectively; P = 0.03). In-hospital death was reported in 6 patients: 2 with a visible thrombus and 4 without (P = 0.09). CONCLUSIONS: Transient thrombus formation is relatively common during the MitraClip procedure, especially in patients with low LVEF; however, acute clinical consequences are benign.

New-generation drug eluting stent vs. bare metal stent in saphenous vein graft - 1 year outcomes by a propensity score ascertainment (SVG Baltic Registry).

BACKGROUND: Data regarding the efficacy of the percutaneous coronary intervention (PCI) with new-designed drug-eluting stent (new-DES) vs. bare metal stent (BMS) of saphenous vein grafts (SVG) stenosis is scarce. The primary objective was to compare one-year clinical outcomes of PCI in stenosis of SVG using new-DES vs. BMS in a real-world population. METHODS AND RESULTS: We carried out a multi-center registry comparing new-DES with BMS in all consecutive patients undergoing PCI of SVG. The primary composite endpoint was major adverse cardiac and cerebrovascular events (MACCE) at 1 year. This observation included 792 consecutive patients (mean age 69 ±â€¯8.9y), treated with either new-DES (n = 379, 47.9%) or BMS (n = 413, 52.1%). Among patients treated with new-DES compared with BMS, there was a lower risk of MACCE (21.4% vs. 28.3%, HR = 0.69, 95% CI 0.50-0.95, p = 0.025) as well as myocardial infarction (MI) (6.3% vs. 12.1%; HR 0.49, 95% CI 0.30-0.82, p = 0.005) at 1 year. After propensity score adjustment, the similar, significant reduction in MACCE and MI was observed in favor of new-DES (HR 0.66, 95% CI 0.46-0.96, p = 0.030; and HR 0.53, 95% CI 0.31-0.92, p = 0.020, respectively). CONCLUSION: In patients undergoing PCI of SVG, the use of new-DES is associated with a reduced 1-year rate of MACCE and MI compared to BMS.

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.

Periprocedural Myocardial Injury After Recanalization of Single Chronic Coronary Occlusion - A Propensity Score Analysis Comparing Long-Term Clinical Outcomes.

BACKGROUND: Rates and importance of periprocedural myocardial injury (PMI) after crossing coronary chronic total occlusions (CTOs) is not well understood. This study sought to investigate long-term clinical implications of PMI in patients undergoing percutaneous coronary intervention (PCI) for single CTO utilizing antegrade technique. METHODS: Out of 11,957 patients undergoing non-urgent PCI, a total of 1110 patients with symptomatic angina and single CTO were treated by antegrade PCI and observed for up to 10 years. The primary objective included cardiac death, while the secondary aim comprised all major adverse cardiovascular and cerebrovascular event (MACCE) rate. RESULTS: Troponin-defined PMI occurred in 4.7% patients (n = 52). At 1 year, the cardiac death and MACCE rates were significantly higher in patients with vs without PMI (hazard ratio [HR], 5.72; 95% confidence interval [CI], 1.59-20.49; P=.01; HR, 1.84; 95% CI, 1.07-3.18; P=.03, respectively). At long-term follow-up, patients with PMI had a trend toward a higher incidence of cardiac death than patients without PMI (HR, 2.51; 95% CI, 0.99-6.33; P=.05) and no differences were demonstrated in terms of overall MACCE between both groups (HR, 1.19; 95% CI, 0.73-1.93; P=.49). After propensity score adjustment, no significant differences were observed regarding the short-term and long-term outcomes. CONCLUSION: CTO-PCI is a safe procedure if routinely performed in symptomatic patients at a high-volume center. PMI does not influence long-term outcomes after antegrade CTO-PCI.

Successful versus unsuccessful antegrade recanalization of single chronic coronary occlusion: eight-year experience and outcomes by a propensity score ascertainment.

AIMS: The effectiveness of revascularization of chronic total occlusion (CTO) remains intriguing. Thus, we sought to investigate whether a successful PCI for single CTO improves outcomes in a setting of stable angina and chronic occlusion of single coronary artery. METHODS AND RESULTS: Of 11 957 consecutive patients referred for nonurgent PCI between 2003 and 2010, 1110 displayed single CTO and were enrolled to the central CTO-registry database. The primary end-point included all-cause mortality, the secondary end-point a composite of safety outcome measure of all-cause death, nonfatal-MI, the need for urgent revascularization and stroke. The major adverse cardiovascular event (MACE) records were extracted from the national administrative database and all patients were linked to the long-term follow-up. Since the patient assignment was not random, we performed the propensity scoring to minimize selection bias; 734 patients (66%) had a successful PCI-CTO. Compared with successful procedures, unsuccessful procedures had similar rates of all-cause death both in crude (HR, 0.78; 95%CI, 0.49-1.25; P = 0.30) and adjusted analysis (HR, 0.80; 95%CI, 0.50-1.28; P = 0.34). A similar, significant reduction in overall MACE was noted with successful PCI-CTO compared with unsuccessful procedure in unadjusted (HR, 0.74; 95%CI, 0.56-0.96; P = 0.020) and adjusted calculation (HR, 0.73; 95%CI, 0.56-0.96; P = 0.019). Patients after successful PCI-CTO as compared with failed recanalization less frequently underwent surgical revascularization. The benefit was sustained at 3 years follow-up. CONCLUSIONS: Successful PCI for single CTO does not improve long-term survival, nonetheless, is associated with reduced overall MACE and the need for surgical revascularization.

Successful recanalisation of isolated chronic total occlusions improves outcomes in long-term observation: a case-control study.

BACKGROUND AND AIM: The long-term benefit of percutaneous recanalisation of chronic total occlusion (CTO) is still unclear. Given advances in interventional cardiology over the last two decades, we sought to investigate whether a successful percutaneous coronary intervention for CTO (PCI-CTO) improves outcomes in an age- and gender-matched single-centre cohort of stable angina patients. METHODS: Out of 401 consecutive patients enrolled to the CTO-Registry database, 276 patients were included in the final analysis. Patients with unsuccessful PCI-CTO (n = 138) were age- and gender-matched in a 1:1 ratio with patients who underwent a successful procedure. The primary end-points included hard end-points comprising death and nonfatal myocardial infarction (MI) and a composite safety outcome measure of death, nonfatal MI and ischaemia-driven revascularisation. The secondary end-point was improvement in angina status or complete resolution of angina symptoms. Patients were followed up for six months and at two years. RESULTS: Patients who underwent a successful recanalisation of CTO, compared to those who underwent an unsuccessful procedure, revealed similar rates of composite death and MI at six months (0.7% vs. 1.4%; hazard ratio [HR], 0.50; 95% confidence interval ratio [CI], 0.05-4.80; p = 0.56) and two years (1.4% vs. 5.8%; HR 0.24; 95% CI 0.07-0.85; p = 0.053). A significant difference in composite safety end-points between subsets, although not recorded after six months of observation (8.7% vs. 15.2%; HR 0.54; 95% CI 0.27-1.07; p = 0.095), was noted at two years follow-up (15.2% vs. 29.7%; HR 0.47; 95% CI 0.29-0.77; p = 0.004). A greater improvement in symptom burden or resolution of angina symptoms was documented after a successful PCI at both six months (68.1% vs. 23.2%, p < 0.001; 80.4% vs. 34.8%, p < 0.001, respectively) and two years (52.2% and 8.0%, p < 0.001; 68.1% vs. 22.5%, p < 0.001, respectively). CONCLUSIONS: Successful recanalisation of CTO improves outcomes in long-term observation.

Major adverse cardiovascular events after drug-eluting stent implantation in patients with single chronic total occlusion: a single-center registry.

BACKGROUND: There are limited data on the long-term safety and efficacy of drug-eluting stents (DES) implantation in patients with stable angina referred for elective percutaneous coronary intervention (PCI) of chronic total occlusion (CTO). We therefore aim to investigate whether DES compared with bare-metal stent (BMS) implantation improves long-term outcomes after successful recanalization of single CTO. METHODS: A total of 345 consecutive patients who underwent successful recanalization of single CTO and received DES or BMS in the Cardioangiology Laboratories of the Medical University of Gdansk between January 1, 2006 and December 31, 2010 were included in the CTO Registry database. We compared the 1-year and long-term clinical outcomes of 137 consecutive patients who underwent PCI for CTO and DES implantation with outcomes of 208 patients after successful CTO treatment with BMS implantation. The median follow-up was 22.6 ± 3 months (21.0 ± 3.9 months for DES vs 23.6 ± 1.5 months for BMS; P<.001). The primary endpoints included a composite of all-cause death and non-fatal myocardial infarction (MI) and composite safety endpoint of major adverse cardiovascular events (MACEs), including death, MI and symptom-driven target lesion revascularization (TLR). A secondary endpoint was a symptom-driven TLR. RESULTS: After stent implantation we noted lower rates of the composite endpoint at 1-year (9.5% DES vs 18.3% BMS; P=.01) and long-term follow-up (11.7% DES vs 21.1% BMS; P=.02) due to fewer episodes of TLR in the DES group (5.1% DES vs 14.4% BMS; P=.006 at 1-year follow-up; 7.3% DES vs 14.4% BMS; P=.04 at long-term follow-up). No significant differences were documented in the rate of death, MI, or in-stent thrombosis between investigated subsets. After adjusting for patient and procedural characteristics as well as propensity, BMS implantation remained independently associated with an increased hazard of 1-year MACE (adjusted hazard ratio [AHR], 2.09; 95% confidence interval [CI], 1.2-3.64; P=.005) and long-term MACEs (AHR, 1.99; 95% CI, 1.18-3.38; P<.01). CONCLUSIONS: DES implantation during PCI for single CTO reduces MACE rate at 1-year and long-term follow-up due to the significant reduction of TLR in the DES group. Therefore, DES implantation should be preferred as an optimal treatment strategy of single CTO in stable angina patients.

[Catastrophic antiphospholipid syndrome complicated by cardiogenic shock - a case report]. / Katastroficzny zespól antyfosfolipidowy przebiegajacy ze wstrzasem kardiogennym - opis przypadku.

A case of a 29-year-old woman 18 days after delivery with catastrophic antiphospholipid syndrome secondary (CAPS) due to undiagnosed systemic lupus erythematosus, leading to cardiogenic shock is reported. Laboratory evaluation revealed increased anticardiolipin antibodies, lupus anticoagulant, antinuclear antibody and thrombocytopenia. Left ventricular ejection fraction was 20%, neurologic deficit and acute renal failure were also present. Cardiac involvement is common in CAPS, but cardiomyopathy due to microvascular thrombosis is rare. CAPS should be considered as a cause of acute heart failure in a women with systemic lupus erythematosus. In the presented case early therapy with anticoagulants, steroids, immunoglobulins and plasmaferesis was beneficial.