Łukasz Rzeszutko

Novel paclitaxel-eluting, biodegradable polymer coated stent in the treatment of de novo coronary lesions: a prospective multicenter registry.

Objectives: The purpose of the present study was to evaluate the efficacy and safety of a biodegradable polymer coated, paclitaxel eluting stent (Luc‐Chopin2) based on 9‐months angiographic and 12‐months clinical follow‐up results. Background: First‐generation drug‐eluting stents utilize nonbioabsorbable polymeric coatings, whose persistent presence in the arterial wall may negatively affect long‐term outcomes. Bioabsorbable coatings with a degradation period matched to that of the drug elution may be a better alternative, clinically and economically. Methods: We conducted a prospective, multicenter first‐in‐man registry of a novel, locally developed, bioabsorbable‐coated, paclitaxel‐eluting coronary stent in 116 patients with single‐lesion de novo coronary disease. Results: Major adverse cardiac events occurred in 7.8% patients within 12 months. There were no late thrombotic events, death, stroke, or surgical revascularization in that period. There were two myocardial infarctions, one related to recent subacute stent thrombosis and another associated with restenosis. By 12 months, target vessel revascularization was performed in 7.8%; 2.9% were ischemia‐driven and the rest were mandated at 9 months in accordance with a control angiography protocol. Core‐lab assessed binary in‐stent restenosis (≥50% DS) was noted in 11.9% patients and mean late loss was 0.46 ± 0.47 mm. Conclusions: This first‐in‐man experience obtained in a multicenter registry of real‐world de novo lesions (almost half of lesions were class B2 or C by AHA classification) showed a favorable safety profile and acceptable efficacy through 12 months. Randomized comparison with a benchmark nonbioabsorbable polymer coated paclitaxel eluting stent should be undertaken to validate this initial positive experience.

Assessment of Culprit Plaque Temperature by Intracoronary Thermography Appears Inconclusive in Patients With Acute Coronary Syndromes

Objective—Safety and feasibility evaluation of intracoronary temperature measurements in patients with acute coronary syndromes (ACS) using a catheter based thermography system. Methods and Results—Thermography was performed in 40 patients with ACS. A 3.5-F thermography catheter containing 5 thermocouples measuring vessel wall temperature, and 1 thermocouple measuring blood temperature (accuracy 0.05°C) was used. Gradient (&Dgr;Tmax) between blood temperature (Tbl) and the maximum wall temperature during pullback was measured. The device showed satisfactory safety in ACS. Only in 16 patients (40%) &Dgr;Tmax was ≥0.1°C. In 23 patients (57.5%) the highest &Dgr;Tmax was found in the culprit segment. &Dgr;Tmax between culprit and adjacent non-culprit segments was observed in patients with transient blood flow interruption during thermography (0.11±0.03 versus 0.08±0.01; P=0.04), in contrast to patients with preserved flow (0.07±0.03 versus 0.06±0.02; P=0.058). Conclusions—The novel, technically sophisticated intracoronary thermography proved its safety and feasibility. However, we were not able to convincingly and consistently differentiate between different lesions at risk, despite a selection of lesions that should appear most distinct to differentiate. A systematic interruption of flow may be necessary to achieve diagnostic results consistently, although such requirement may unfavorably change the risk-to-benefit ratio of this developing technology.

Short- and intermediate-term improvement of patient quality of life after transcatheter aortic valve implantation: a single-centre study

BACKGROUND Transcatheter aortic valve implantation (TAVI) is a treatment option for elderly high-risk patients with symptomatic severe aortic stenosis. Improvement of quality of life (QoL) is a relevant issue in this group of patients. AIM To assess changes in QoL after TAVI. METHODS Forty patients who underwent TAVI in our institution were included in this QoL study. All subjects were screened for TAVI in a standard fashion, including QoL assessment with the EQoL (EQ-5D-3L). The pre- and postprocedural scores obtained up to a 12-month follow-up were assessed. RESULTS Median of logistic EuroScore I was 21.5% (13.5-26.75%), and Society of Thoracic Surgeons score was 5.5% (4.0-10.75%). Comparison of baseline values with follow-up data at one, six and 12 months after TAVI showed significant improvement of QoL (p < 0.001). Visual Analogue Scale score (VAS score) was assessed. There was an incremental increase in VAS score during follow-up (p < 0.001). Median of six-minute walk test distance at baseline was 200 m (IQR 150-300) and 325 m (IQR 250-400) 12 months after TAVI (p < 0.001). CONCLUSIONS TAVI provides improved QoL and effectively relieves symptoms.

Acute and long-term outcomes of percutaneous balloon aortic valvuloplasty for the treatment of severe aortic stenosis.

This study aimed to evaluate the indications, short‐ and long‐term outcomes of balloon aortic valvuloplasty (BAV) in patients with severe aortic stenosis (AS).

Long-term follow-up of mesh-covered stent implantation in patients with ST-segment elevation myocardial infarction

BACKGROUND The MGuard stent (a bare-metal stent wrapped externally in a polymer mesh sleeve) was introduced to reduce the risk of distal embolisation and no-reflow phenomenon during percutaneous coronary intervention (PCI) in thrombus containing lesions, including ST-segment elevation myocardial infarction (STEMI). However, data on the long-term performance of the MGuard stent is limited. AIM To assess the long-term safety and efficacy of MGuard stent implantation during primary PCI for STEMI. METHODS AND RESULTS In this multicentre study, a total of 60 patients with STEMI ≤12 h treated with the MGuard stent were enrolled. Angiographic success of PCI was achieved in 96.7%, with the final TIMI grade 3 flow in 90.0% of patients. At six months, the overall rate of major adverse cardiac and cerebrovascular events (MACCE; composite of cardiac death, nonfatal target vessel reinfarction, target lesion revascularisation, and stroke) was 1.7%. A long-term follow-up of the study was successfully performed in 57 patients (mean follow-up of 38.7 ± 3.1 months). The long-term cardiac mortality was 7.0%, with a MACCE rate of 8.8%. There was no decrease in the left ventricular ejection fraction and no enlargement of the left ventriclebetween index and long-term follow-up echocardiogram. CONCLUSIONS The early safety and efficacy of the MGuard stent was maintained during the long-term follow-up. However, comparative data from ongoing randomised clinical trials are still required to confirm the long-term efficacy of MGuard stent implantation in patients with STEMI.

Twelve-Month Quality of Life Improvement and All-Cause Mortality in Elderly Patients Undergoing Transcatheter Aortic Valve Replacement:

Purpose Restoration of quality of life (QoL) and improvement of clinical outcomes is crucial in elderly patients undergoing transcatheter aortic valve implantation (TAVI). We sought to evaluate changes in QoL and all-cause mortality 12 months after TAVI. Methods A total of 101 patients who underwent TAVI were included. Patients were followed for 12 months. QoL was assessed at baseline and at 1, 6 and 12 months after TAVI using EQ-5D-3L with a visual analog scale (VAS). Results Patients who reported some problems with mobility at baseline showed better mobility after 12 months (p = 0.001). On the other hand, those who reported issues with self-care, usual activity or pain did not show significant improvement (p = 0.41; p = 0.12; p = 0.27, respectively). Patients reporting anxiety at baseline improved 12 months later (p = 0.003). VAS score showed an incremental increase during follow-up (p<0.001). Transfemoral access was associated with higher VAS score values after 1 month (median (IQR): 65.0 (50.0–75.0) vs. 54.0 (50.0–60.0); p = 0.019) but not after 12 months (70.0 (62.5–80.0) vs. 67.5 (55.0–70.0); p = 0.07) as compared to non-transfemoral access. In multivariable regression analysis, only age and the presence of coronary chronic total occlusion were independently associated with VAS score at 12 months. In-hospital, 1-, 6- and 12-month mortality rates were 6.9%, 10.9%, 15.8 and 17.8%, respectively. Conclusions TAVI provides improved QoL with relatively good clinical outcomes. However, not all components of QoL may be improved. Patients treated with transfemoral access might have better QoL than those who had non-transfemoral access, especially early after TAVI.

Biodegradable vascular scaffold ABSORB BVS™ – scientific evidence and methods of implantation

Since 2006, over 600 biodegradable vascular scaffolds (BVS) have been implanted worldwide in clinical trials such as ABSORB cohort A and B, ABSORB Extend and ABSORB II RCT. Due to completely changed construction and mechanical properties of BVS, the choice of proper scaffold diameter and its implantation differ significantly from those used in the case of metal stents (bare metal stent (BMS) or drug eluting stent (DES)). Furthermore, all data concerning BVS efficacy and safety come from clinical trials, conducted in a selected group of patients. In 2012 BVS ABSORB™ was approved as the first biodegradable scaffold for the treatment of coronary artery disease in EU and other countries, with a limitation of use only for experienced and trained interventional cardiologists. As one of the most experienced clinical centers in Europe and the first one that in 2006 implanted BVS ABSORB™ in Poland we have a great pleasure and honor to share our experience with interventional cardiologists who would like to prepare for BVS ABSORB™ implantation in their centers. In this article we wanted to summarize the clinical data from already finished and ongoing trials, give a short overview of patient selection, and provide a detailed description of the implantation process with tips which could be helpful during BVS use.

Twelve months clinical outcome after bioresorbable vascular scaffold implantation in patients with stable angina and acute coronary syndrome. Data from the Polish National Registry

Introduction There are limited data describing bioresorbable vascular scaffold (BVS) implantation in complex lesions. Only short-term clinical outcomes are available for patients with acute coronary syndrome (ACS). Aim To evaluate 12-month clinical outcome, safety and effectiveness of BVS implantation in complex lesions and in stable angina (SA) or ACS. Material and methods Five hundred ninety-one patients with SA/ACS were enrolled between October 2012 and November 2013 in 30 invasive cardiology centres in Poland. At least one BVS implantation during percutaneous coronary intervention (PCI) was the only inclusion criteria. The clinical endpoint was the occurrence of a major adverse cardiovascular event (MACE) (all-cause death, myocardial infarction (MI), clinically driven target lesion revascularisation (TLR) with urgent PCI or target vessel revascularisation (TVR) with urgent coronary artery bypass grafting (CABG)) and device-oriented composite endpoint (DOCE) (cardiac death, urgent target vessel revascularisation with PCI/CABG, target vessel MI) during 12-month follow-up. Results After 12 months TLR with urgent PCI was significantly more often reported in patients with diagnosed UA (4.59%; p < 0.02) in comparison with other PCI indications. No significant differences were found in terms of composite MACE endpoint, cumulative MACE (p = 0.09), stent thrombosis (p = 0.2) or restenosis (p = 0.2). There were no significant differences in cumulative MACE and composite MACE endpoint between patients with no/mild versus moderate/severe tortuosity and no/mild versus moderate/severe calcification of the target vessel. No significant difference was found between groups of patients with or without bifurcation of the target vessel. Device-oriented composite endpoint was significantly more often reported in the ACS group (3.2% vs. 0.47%; p < 0.03), most frequently in patients with diagnosed UA (5.5%). Conclusions Bioresorbable vascular scaffold can be successfully and safely used for ACS treatment and in lesions of higher complexity.

Effects of short-term anti-inflammatory therapy on endothelial function in patients with non-ST-segment elevation acute coronary syndrome

The aim was to assess the impact of the short-term anti-inflammatory therapy on coronary endothelial function in non-ST-segment elevation acute coronary syndrome patients. In 30 patients, coronary endothelial function was assessed by acetylcholine test. Vessel response was calculated as a percent change of mean lumen diameter (MLD). Then patients were randomized into three groups: A (n = 11) placebo, B (n = 11) 80 mg atorvastatin, C (n = 8) 80 mg atorvastatin and 25 mg rofecoxib. After 7 days control test was performed. Recovery of coronary endothelial function was calculated as delta in percent changes of MLD between Days 1 and 7. On Day 1, percent change of MLD between baseline and maximum acetylcholine did not differentiate the groups: -20 ± 3.5% in A, -25 ± 3.9% in B and -26 ± 3.7% in C, P = .20. On Day 7, percentage changes in MLD were as follows: -21 ± 3.9% in A, -15 ± 3.0% in B and -10 ± 4.0% in C, P=.002. The delta in percentage change in MLD between Days 1 and 7 were as follows: -1% in A, + 10% in B and +16% in C, P = .02. In conclusion, short-term, anti-inflammatory therapy with high-dose atorvastatin and selective cyclooxygenase-2 inhibitor improves coronary endothelial function within 7 days in non-ST-segment elevation acute coronary syndrome patients.

Patient profile and periprocedural outcomes of bioresorbable vascular scaffold implantation in comparison with drug-eluting and bare-metal stent implantation. Experience from ORPKI Polish National Registry 2014–2015

Introduction There are limited data on the comparison of bioresorbable vascular scaffold (BVS) and drug-eluting stent (DES)/bare-metal stent (BMS) implantation in an unselected population of patients with coronary artery disease. Aim To compare the periprocedural outcomes and patient profile of BVS and DES/BMS implantation in an all-comer population from the ORPKI Polish National Registry. Material and methods A total of 141,324 consecutive patients from 151 invasive cardiology centers in Poland were included in this prospective registry between January 2014 and June 2015. Periprocedural data on patients with at least one BVS (Absorb, Abbott Vascular, Santa Clara, CA, USA), DES or BMS (all available types) implantation in de novo lesions during index percutaneous coronary intervention for stable angina (SA) or acute coronary syndrome were collected. Results Bioresorbable vascular scaffold was the most often used in patients with SA, in single-vessel disease and in younger male patients. Bioresorbable vascular scaffold implantation was significantly more often associated with periprocedural administration of ticagrelor/prasugrel (6.8% vs. 3.6%; p = 0.001) and use of intravascular ultrasound and optical coherence tomography in comparison with the DES/BMS group (2.8% vs. 0.6% and 1.8% vs. 0.1%, respectively; p = 0.001 for both). The incidence of periprocedural death was significantly lower in the BVS group than the DES/BMS group (0.04% vs. 0.32%; p = 0.02), but this difference was no longer significant after adjustment for covariates. On the other hand, coronary artery perforation occurred significantly more often during BVS delivery (0.31% vs. 0.12%; p = 0.01), and BVS implantation was identified as an independent predictor of coronary artery perforation in multivariate logistic regression analysis (OR = 6.728, 95% CI: 2.394–18.906; p = 0.001). Conclusions Patients treated with BVS implantation presented an acceptable safety and efficacy profile in comparison with the DES/BMS group. However, lower risk patients were the most frequent candidates for BVS implantation.