Percutaneous repair of moderate-to-severe or severe functional mitral regurgitation in patients with symptomatic heart failure: Baseline characteristics of patients in the RESHAPE-HF2 trial and comparison to COAPT and MITRA-FR trials.

AIM: The RESHAPE-HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. METHODS AND RESULTS: The RESHAPE-HF2 study is an investigator-initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate-to-severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5.3 (2.8-9.0) and median plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 2745 (1407-5385) pg/ml. Most patients were prescribed beta-blockers (96%), diuretics (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium-glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end-diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0.25 ± 0.08 cm2, respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA-FR, those enrolled in RESHAPE-HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT-proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF. CONCLUSION: Patients enrolled in RESHAPE-HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate-to-severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA-FR trials. The results of RESHAPE-HF2 will provide crucial insights regarding broader application of the transcatheter edge-to-edge repair procedure in clinical practice.

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.

Predictors of Clinical Success After Transcatheter Paravalvular Leak Closure: An International Prospective Multicenter Registry.

BACKGROUND: Transcatheter closure of a symptomatic prosthetic paravalvular leak (PVL) is feasible, but there is presently no conclusive evidence to show consistent efficacy. We aimed to identify predictors of clinical success after transcatheter PVL closure. METHODS: Consecutive patients referred to 24 European centers for transcatheter PVL closure in 2017 to 2019 were included in a prospective registry (Fermeture de Fuite ParaProthétique, FFPP). Clinical success was absence of any of the following within 1 month: re-admission for heart failure, blood transfusion, open-heart valvular surgery, and death. RESULTS: We included 216 symptomatic patients, who underwent 238 percutaneous PVL closure procedures on the mitral (64.3%), aortic (34.0%), or tricuspid (1.7%) valve. Symptoms were heart failure, hemolytic anemia, or both in 48.9%, 7.8%, and 43.3% of patients, respectively. One, 2, and 3 leaks were treated during the same procedure in 69.6%, 26.6%, and 3.8% of patients, respectively. The PVL was pinpoint or involved 1/8 or 1/4 of the valve circumference in 18.6%, 52.4%, and 28.1% of cases, respectively. The most frequently used devices were the Vascular Plug 3, Ventricular Septal Defect Occluder, Vascular Plug 2, and Paravalvular Leak Device (45.0%, 16.6%, 14.2%, and 13.6% of cases, respectively). Successful device(s) implantation with leak reduction to ≤grade 2 was obtained in 85.0% of mitral and 91.4% of aortic procedures, respectively (P=0.164); with major periprocedural adverse event rates of 3.3% and 1.2%, respectively (P=0.371); and clinical success rates of 70.3% and 88.0%, respectively (P=0.004). By multivariate analysis, technical failure, mechanical valve, and hemolytic anemia were independently associated with absence of clinical success (odds ratios [95% CIs], 7.7 [2.0-25.0]; P=0.002; 3.6 [1.1-11.1]; P=0.036; and 3.7 [1.2-11.9]; P=0.025; respectively). CONCLUSIONS: Transcatheter PVL closure is efficient and safe in symptomatic patients but is associated with a lower clinical success rate in patients with hemolysis and/or a mechanical valve. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifiers: NCT05089136.

Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER): protocol for a prospective observational nationwide study.

INTRODUCTION: Atrial fibrillation (AF) is a prevalent disease considerably contributing to the worldwide cardiovascular burden. For patients at high thromboembolic risk (CHA2DS2-VASc ≥3) and not suitable for chronic oral anticoagulation, owing to history of major bleeding or other contraindications, left atrial appendage occlusion (LAAO) is indicated for stroke prevention, as it lowers patient's ischaemic burden without augmentation in their anticoagulation profile. METHODS AND ANALYSIS: Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER) will be conducted in 10 heart surgery and cardiology centres across Poland to assess the outcomes of LAAO performed by fully thoracoscopic-epicardial, percutaneous-endocardial or hybrid endo-epicardial approach. The registry will include patients with nonvalvular AF at a high risk of thromboembolic and bleeding complications (CHA2DS2-VASc Score ≥2 for males, ≥3 for females, HASBLED score ≥2) referred for LAAO. The first primary outcome is composite procedure-related complications, all-cause death or major bleeding at 12 months. The second primary outcome is a composite of ischaemic stroke or systemic embolism at 12 months. The third primary outcome is the device-specific success assessed by an independent core laboratory at 3-6 weeks. The quality of life (QoL) will be assessed as well based on the QoL EQ-5D-5L questionnaire. Medication and drug adherence will be assessed as well. ETHICS AND DISSEMINATION: Before enrolment, a detailed explanation is provided by the investigator and patients are given time to make an informed decision. The patient's data will be protected according to the requirements of Polish law, General Data Protection Regulation (GDPR) and hospital Standard Operating Procedures. The study will be conducted in accordance with the Declaration of Helsinki. Ethical approval was granted by the local Bioethics Committee of the Upper-Silesian Medical Centre of the Silesian Medical University in Katowice (decision number KNW/0022/KB/284/19). The results will be published in peer-reviewed journals and presented during national and international conferences. TRIAL REGISTRATION NUMBER: NCT05144958.

Paravalvular Leak Echo Imaging before and during the Percutaneous Procedure.

Percutaneous device closure has become a valuable alternative to surgery in the management of paravalvular leaks. Consequently, imaging in these patients is currently not only meant to verify the hemodynamic significance of the lesion but also to assess the feasibility of transcatheter treatment. We present a methodology of comprehensive echocardiography assessment that allows for the selection of patients and plans the intervention. Next, procedure-oriented steps of echocardiography imaging, which are essential for eventual success, are reviewed.

Procedural and 1-year outcomes following large vessel coronary artery perforation treated by covered stents implantation: Multicentre CRACK registry.

BACKGROUND: Data regarding the clinical outcomes of covered stents (CSs) used to seal coronary artery perforations (CAPs) in the all-comer population are scarce. The aim of the CRACK Registry was to evaluate the procedural, 30-days and 1-year outcomes after CAP treated by CS implantation. METHODS: This multicenter all-comer registry included data of consecutive patients with CAP treated by CS implantation. The primary endpoint was the composite of major adverse cardiac events (MACEs), defined as cardiac death, target lesion revascularization (TLR), and myocardial infarction (MI). RESULTS: The registry included 119 patients (mean age: 68.9 ± 9.7 years, 55.5% men). Acute coronary syndrome, including: unstable angina 21 (17.6%), NSTEMI 26 (21.8%), and STEMI 26 (21.8%), was the presenting diagnosis in 61.3%, and chronic coronary syndromes in 38.7% of patients. The most common lesion type, according to ACC/AHA classification, was type C lesion in 47 (39.5%) of cases. A total of 52 patients (43.7%) had type 3 Ellis classification, 28 patients (23.5%) had type 2 followed by 39 patients (32.8%) with type 1 perforation. Complex PCI was performed in 73 (61.3%) of patients. Periprocedural death occurred in eight patients (6.7%), of which two patients had emergency cardiac surgery. Those patients were excluded from the one-year analysis. Successful sealing of the perforation was achieved in 99 (83.2%) patients. During the follow-up, 26 (26.2%) patients experienced MACE [7 (7.1%) cardiac deaths, 13 (13.1%) TLR, 11 (11.0%) MIs]. Stent thrombosis (ST) occurred in 6 (6.1%) patients [4(4.0%) acute ST, 1(1.0%) subacute ST and 1(1.0%) late ST]. CONCLUSIONS: The use of covered stents is an effective treatment of CAP. The procedural and 1-year outcomes of CAP treated by CS implantation showed that such patients should remain under follow-up due to relatively high risk of MACE.

Safety and effectiveness of the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease: SPARTA, a multicenter experience.

AIMS: To assess the long-term outcomes of patients treated with sirolimus-eluting Stentys stent in a real-life setting. BACKGROUND: Few data regarding the safety and effectiveness of self-apposing sirolimus-eluting Stentys stent are available. METHODS: 278 patients (30% stable coronary artery disease, 70% acute coronary syndromes, and 54% on unprotected left main) treated with sirolimus eluting Stentys stent were retrospectively included in the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease multicenter registry. Major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, target lesion revascularization, stent thrombosis) were the primary end-point, single components of MACE were the secondary ones. RESULTS: After 13 months (interquartile range 5-32), MACE was 14%. Stent thrombosis occurred in 3.9% of the patients (2.5% definite stent thrombosis and 1.4% probable stent thrombosis), 66% of them presenting with ST-segment elevation myocardial infarction (STEMI) at admission. Cardiovascular death, target lesion revascularization and myocardial infarction was 4.7%, 8.3%, and 7.2%, respectively. At multivariate analysis, risk of MACE was increased by diabetes (hazard ratios 4.76; P = 0.002) but was not affected by the indication leading to sirolimus-eluting Stentys stent implantation (marked vessel tapering vs. coronary ecstasies, hazard ratios 0.74, P = 0.71). CONCLUSION: Sirolimus-eluting Stentys stent may represent a potential solution for specific coronary anatomies such as bifurcation, ectasic, or tapered vessels. Risk of stent thrombosis appears related to clinical presentation with STEMI and to anatomic features, stressing the importance of the use of intracoronary imaging for self-expandable stents implantation.

Midterm procedural and clinical outcomes of percutaneous paravalvular leak closure with the Occlutech Paravalvular Leak Device.

AIMS: The aim of this study was to assess the efficacy and safety of the Occlutech Paravalvular Leak Device (PLD) for the percutaneous closure of paravalvular leaks (PVL). METHODS AND RESULTS: Patients with PVL were enrolled at 21 sites from nine countries. Indications for PVL closure were heart failure and/or haemolytic anaemia. Endpoint measures were changes in PV regurgitation grade, NYHA class and requirement for haemolysis-related transfusion. One-hundred and thirty-six patients with mitral (67.6%) or aortic (32.4%) leaks were included (mean age 66.7 years, 58% male); 31% had multiple PVLs. The proportion of patients with NYHA Class III/IV decreased from 77.3% at baseline to 16.9% at latest follow-up. The proportion of patients with need for haemolysis-related blood transfusion decreased from 36.8% to 5.9% and from 8.3% to 0% for ML patients and AL patients, respectively. All-cause mortality was 7.4%. Complications included interference with valve leaflets (0.7%), transient device embolisation (percutaneously solved) (0.7%), late device embolisation (0.7%), recurrent haemolytic anaemia (2.2%), new-onset haemolytic anaemia (0.7%), valve surgery (2.2%), need for repeat closure (0.7%), complications at femoral puncture site (0.7%) and arrhythmias requiring treatment (4.4%). CONCLUSIONS: PVL closure with the Occlutech PLD demonstrated a high success rate associated with significant clinical improvement and a relatively low rate of serious complications. Visual summary. PVL characteristics, leak approach, device types and midterm procedural and clinical outcomes of percutaneous paravalvular leak closure with the Occlutech® PLD. Transcatheter PVL closure with the specifically designed PLD was demonstrated to be effective with a relatively low rate of major complications. Procedural success for ML and AL closure was high with a low rate of residual or recurrent leaks. Significant improvement of NYHA class, and reduction of haemolytic anaemia and transfusion dependency were achieved.

Effects of trans-endocardial delivery of bone marrow-derived CD133+ cells on angina and quality of life in patients with refractory angina: A sub-analysis of the REGENT-VSEL trial.

BACKGROUND: The REGENT-VSEL trial demonstrated a neutral effect of transendocardial injection of autologous bone marrow (BM)-derived CD133+ in regard to myocardial ischemia. The current sub-analysis of the REGENT VSEL trial aims to assess the effect stem cell therapy has on quality of life (QoL) in patients with refractory angina. METHODS: Thirty-one patients (63.0 ± 6.4 years, 70% male) with recurrent CCS II-IV angina, despite optimal medical therapy, enrolled in the REGENT-VSEL single center, randomized, double-blinded, and placebo-controlled trial. Of the 31 patients, 16 individuals were randomly assigned to the active stem cell group and 15 individuals were randomly assigned to the placebo group on a 1:1 basis. The inducibility of ischemia, (≥ one myocardial segment) was confirmed for each patient using Tc-99m SPECT. QoL was measured using the Seattle Angina Questionnaire. Each patient completed the questionnaire prior to treatment and at the time of their outpatient follow-up visits at 1, 4, 6, and 12 months after cell/placebo treatment. RESULTS: The main finding of the REGENT-VSEL trial sub-analysis was that transendocardial injection of autologous BM-derived CD133+ stem cells in patients with chronic refractory angina did not show significant improvement in QoL in comparison to the control group. Moreover, there was no significant difference between cell therapy and placebo in a number of patients showing improvement of at least 1 Canadian Cardiovascular Society class during the follow-up period. CONCLUSIONS: Intra-myocardial delivery of autologous CD133+ stem cells is safe and feasible but does not show a significant improvement in the QoL or angina pectoris symptoms in patients with chronic myocardial ischemia.

Prediction models for different plaque morphology in non-significantly stenosed regions of saphenous vein grafts assessed with optical coherence tomography.

INTRODUCTION: Coronary artery bypass grafting (CABG) is a method of choice in treatment of diffuse coronary artery disease (CAD), although it has some limitations such as late saphenous vein graft (SVG) patency loss, which occurs in one fifth of all conduits at 5 years. Since atherosclerosis in SVG has diffuse characteristics, it appears that significantly and non-significantly stenosed lesions may have an equal impact on worse prognosis. AIM: To assess non-significant lesions of SVG by the use of optical coherence tomography (OCT) and investigate the clinical and laboratory findings with the potential impact on plaque composition. MATERIAL AND METHODS: Twenty-nine patients with 43 non-significant lesions were enrolled in the study. All variables were assessed using uni- and multivariable logistic regression analysis with each plaque morphology as a dependent variable. Odds ratio (OR) and 95% confidence interval (CI) were computed. RESULTS: Plaque rupture (PRT) was independently associated with age (OR = 1.49, 95% CI: 1.09-2.04, p = 0.015) and lower rates of high-density lipoproteins (HDL) cholesterol (OR = 0.67, 95% CI: 0.49-0.92, p = 0.016). Intimal tearing or rupture (ITR) was related to reduced GFR (OR = 0.52, 95% CI: 0.38-0.72, p = 0.0004). Lipid-rich plaque (LRP) was associated with raised platelet count (PLT) (OR = 1.51, 95% CI: 1.16-1.96, p = 0.004) and increased frequency of smoking (OR = 1.45, 95% CI: 1.12-1.89, p = 0.007). CONCLUSIONS: Atherosclerosis of SVG is not restricted to significantly stenosed lesions. Plaque composition is independently associated with different types of clinical and laboratory findings, mostly recognized as risk factors of CAD.

Effects of Transendocardial Delivery of Bone Marrow-Derived CD133+ Cells on Left Ventricle Perfusion and Function in Patients With Refractory Angina: Final Results of Randomized, Double-Blinded, Placebo-Controlled REGENT-VSEL Trial.

RATIONALE: New therapies for refractory angina are needed. OBJECTIVE: Assessment of transendocardial delivery of bone marrow CD133+ cells in patients with refractory angina. METHODS AND RESULTS: Randomized, double-blinded, placebo-controlled trial enrolled 31 patients with recurrent Canadian Cardiovascular Society II-IV angina, despite optimal medical therapy, ≥1 myocardial segment with inducible ischemia in Tc-99m SPECT who underwent bone marrow biopsy and were allocated to cells (n=16) or placebo (n=15). Primary end point was absolute change in myocardial ischemia by SPECT. Secondary end points were left ventricular function and volumes by magnetic resonance imaging and angina severity. After 4 months, there were no significant differences in extent of inducible ischemia between groups (summed difference score mean [±SD]: 2.60 [2.6] versus 3.63 [3.6], P=0.52; total perfusion deficit: 3.60 [3.6] versus 5.01 [4.3], P=0.32; absolute changes of summed difference score: -1.38 [5.2] versus -0.73 [1.9], P=0.65; and total perfusion deficit: -1.33 [3.3] versus -2.19 [6.6], P=0.65). There was a significant reduction of left ventricular volumes (end-systolic volume: -4.3 [11.3] versus 7.4 [11.8], P=0.02; end-diastolic volume: -9.1 [14.9] versus 7.4 [15.8], P=0.02) and no significant change of left ventricular ejection fraction in the cell group. There was no difference in number of patients showing improvement of ≥1 Canadian Cardiovascular Society class after 1 (41.7% versus 58.3%; P=0.68), 4 (50% versus 33.3%; P=0.63), 6 (70% versus 50.0%; P=0.42), and 12 months (55.6% versus 81.8%; P=0.33) and use of nitrates after 12 months. CONCLUSION: Transendocardial CD133+ cell therapy was safe. Study was underpowered to conclusively validate the efficacy, but it did not show a significant reduction of myocardial ischemia and angina versus placebo. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01660581.

First- Versus Second-Generation Drug-Eluting Stents in Acute Coronary Syndromes (Katowice-Zabrze Registry) / Stents Farmacológicos de Primeira Versus Segunda Geração na Síndrome Coronariana Aguda (Registro Katowice-Zabrze)

Abstract Background: There are sparse data on the performance of different types of drug-eluting stents (DES) in acute and real-life setting. Objective: The aim of the study was to compare the safety and efficacy of first- versus second-generation DES in patients with acute coronary syndromes (ACS). Methods: This all-comer registry enrolled consecutive patients diagnosed with ACS and treated with percutaneous coronary intervention with the implantation of first- or second-generation DES in one-year follow-up. The primary efficacy endpoint was defined as major adverse cardiac and cerebrovascular event (MACCE), a composite of all-cause death, nonfatal myocardial infarction, target-vessel revascularization and stroke. The primary safety outcome was definite stent thrombosis (ST) at one year. Results: From the total of 1916 patients enrolled into the registry, 1328 patients were diagnosed with ACS. Of them, 426 were treated with first- and 902 with second-generation DES. There was no significant difference in the incidence of MACCE between two types of DES at one year. The rate of acute and subacute ST was higher in first- vs. second-generation DES (1.6% vs. 0.1%, p < 0.001, and 1.2% vs. 0.2%, p = 0.025, respectively), but there was no difference regarding late ST (0.7% vs. 0.2%, respectively, p = 0.18) and gastrointestinal bleeding (2.1% vs. 1.1%, p = 0.21). In Cox regression, first-generation DES was an independent predictor for cumulative ST (HR 3.29 [1.30-8.31], p = 0.01). Conclusions: In an all-comer registry of ACS, the one-year rate of MACCE was comparable in groups treated with first- and second-generation DES. The use of first-generation DES was associated with higher rates of acute and subacute ST and was an independent predictor of cumulative ST.

Resumo Fundamento: Os dados sobre o desempenho dos diferentes tipos de stents farmacológicos (SF) no cenário agudo e da vida real são escassos. Objetivo: Comparar a segurança e a eficácia dos SF de primeira e de segunda geração em pacientes com síndrome coronariana aguda (SCA). Métodos: Este registro arrolou pacientes consecutivos com diagnóstico de SCA e tratados com intervenção coronariana percutânea e implantação de SF de primeira ou segunda geração em seguimento de 1 ano. O desfecho primário 'eficácia' foi definido como eventos cardíacos adversos maiores (ECAM), um composto de morte por todas as causas, infarto do miocárdio não fatal, revascularização de vaso-alvo e acidente vascular encefálico. O desfecho primário 'segurança' foi trombose de stent (TS) definitiva em 1 ano. Resultados: Do total de 1.916 pacientes arrolados, 1.328 foram diagnosticados com SCA. Desses, 426 foram tratados com SF de primeira geração e 902, com SF de segunda geração. Não houve diferença significativa na incidência de ECAM entre os dois tipos de SF em 1 ano. A taxa de TS aguda e subaguda foi maior com SF de primeira geração do que com os de segunda geração (1,6% vs. 0,1%, p < 0,001; e 1,2% vs. 0,2%, p = 0,025, respectivamente), mas não houve diferença para TS tardia (0,7% vs. 0,2%, respectivamente, p = 0,18) nem para sangramento gastrointestinal (2,1% vs.1,1%, p = 0,21). Na regressão de Cox, o SF de primeira geração foi preditor independente para TS cumulativa [HR 3,29 (1,30-8,31); p = 0,01]. Conclusões: No registro de SCA, a taxa de ECAM em 1 ano foi comparável nos grupos tratados com SF de primeira e de segunda geração. O uso de SF de primeira geração associou-se a maiores taxas de TS aguda e subaguda, sendo um preditor independente para TS cumulativa.

First- Versus Second-Generation Drug-Eluting Stents in Acute Coronary Syndromes (Katowice-Zabrze Registry).

BACKGROUND: There are sparse data on the performance of different types of drug-eluting stents (DES) in acute and real-life setting. OBJECTIVE: The aim of the study was to compare the safety and efficacy of first- versus second-generation DES in patients with acute coronary syndromes (ACS). METHODS: This all-comer registry enrolled consecutive patients diagnosed with ACS and treated with percutaneous coronary intervention with the implantation of first- or second-generation DES in one-year follow-up. The primary efficacy endpoint was defined as major adverse cardiac and cerebrovascular event (MACCE), a composite of all-cause death, nonfatal myocardial infarction, target-vessel revascularization and stroke. The primary safety outcome was definite stent thrombosis (ST) at one year. RESULTS: From the total of 1916 patients enrolled into the registry, 1328 patients were diagnosed with ACS. Of them, 426 were treated with first- and 902 with second-generation DES. There was no significant difference in the incidence of MACCE between two types of DES at one year. The rate of acute and subacute ST was higher in first- vs. second-generation DES (1.6% vs. 0.1%, p < 0.001, and 1.2% vs. 0.2%, p = 0.025, respectively), but there was no difference regarding late ST (0.7% vs. 0.2%, respectively, p = 0.18) and gastrointestinal bleeding (2.1% vs. 1.1%, p = 0.21). In Cox regression, first-generation DES was an independent predictor for cumulative ST (HR 3.29 [1.30-8.31], p = 0.01). CONCLUSIONS: In an all-comer registry of ACS, the one-year rate of MACCE was comparable in groups treated with first- and second-generation DES. The use of first-generation DES was associated with higher rates of acute and subacute ST and was an independent predictor of cumulative ST.

Long-term follow-up of renal arteries after radio-frequency catheter-based denervation using optical coherence tomography and angiography.

Optical coherence tomography (OCT) imaging at the time of renal denervation (RDN) showed that procedure might cause spasm, intimal injury or thrombus formation. In the present study, we assessed the healing of renal arteries after RDN using OCT and renal angiography in long-term follow-up. OCT and renal angiography were performed in 12 patients (22 arteries) 18.41 ± 5.83 months after RNS. There were no adverse events or complications during the long-term follow-up. In ten patients (83 %), significant reductions of blood pressure was achieved without a change of the antihypertensive medications. We demonstrated the presence of 26 areas of focal intimal thickening identified by OCT in 10 (83 %) patients and in 14 (63 %) arteries. The mean area of focal intimal thickening was 0.054 ± 0.033 mm(2). No vessel dissection, thrombus, intimal tear or acute vasospasm were observed during the OCT analysis. Also, the quantitative angiography analysis revealed a significant reduction of the minimal and proximal lumen diameters at follow-up as compared to measurements obtained before RDN. Renal arteries have a favorable "long-term" vessel healing response after RDN. Focal intimal thickening and a modest reduction of the minimal lumen diameter may be observed after RF denervation. Further studies are needed to determine whether intravascular imaging may be helpful in evaluating the vessel healing of RF RDN.

Transcatheter reduction of paravalvular leaks: a systematic review and meta-analysis.

BACKGROUND: Significant paravalvular leak (PVL) after surgical valve replacement can result in intractable congestive heart failure and hemolytic anemia. Because repeat surgery is performed in only few patients, transcatheter reduction of PVL is emerging as an alternative option, but its safety and efficacy remain uncertain. In this study we sought to assess whether a successful transcatheter PVL reduction is associated with an improvement in clinical outcomes. METHODS: We identified 12 clinical studies that compared successful and failed transcatheter PVL reductions in a total of 362 patients. A Bayesian hierarchical meta-analysis was performed using cardiac mortality as a primary end point. The combined occurrence of improvement in New York Heart Association functional class or hemolytic anemia and the need for repeat surgery, were used as secondary end points. RESULTS: A successful transcatheter PVL reduction was associated with a lower cardiac mortality rate (odds ratio [OR], 0.08; 95% credible interval [CrI], 0.01-0.90) and with a superior improvement in functional class or hemolytic anemia, compared with a failed intervention (OR, 9.95; 95% CrI, 2.10-66.73). Fewer repeat surgeries were also observed after successful procedures (OR, 0.08; 95% CrI, 0.01-0.40). CONCLUSIONS: A successful transcatheter PVL reduction is associated with reduced all-cause mortality and improved functional class in patients deemed unsuitable for surgical correction.

Transapical closure of mitral paravalvular leaks with use of amplatzer vascular plug III.

INTRODUCTION: Paravalvular leak (PVL) may complicate cardiac valve replacement surgery. Radical treatment is required if a PVL produces heart failure (HF) symptoms or severe hemolysis. Even though transcatheter PVL closure (TPVLC) has become a valid alternative to reoperation, a number of anatomical conditions may prove technically challenging for transvascular access. We intended to verify the utility of transapical access in such settings. METHODS: We report a prospective series of 7 patients with mitral PVLs who underwent transapical TPVLC. The Heart Team made the choice of treatment and Amplatzer Vascular Plug III devices were used off-label as occluders. RESULTS: Transapical TPVLC enabled excellent sealing of mitral PVL in 6 cases. This resulted in HF symptom reduction and decreased NT-proBNP plasma concentration. No procedure-related complications occurred. CONCLUSIONS: Transapical access seems to be an efficient and safe alternative for transvascular approach for mitral TPVLC, but further technical development is still needed.