[Show abstract][Hide abstract] ABSTRACT: We aimed to evaluate the long-term safety and efficacy of the STENTYS self-apposing paclitaxel-eluting stent (STENTYS-PES) in bifurcation lesions in routine clinical practice.
The primary endpoint of the study was the composite major adverse cardiac events (MACE: cardiac death, myocardial infarction, clinically driven target lesion revascularisation, or emergent bypass surgery) assessed at six months after enrolment. This was reported in 21 patients (10.1%), mainly due to clinically driven target lesion revascularisation (TLR). At 12 months, 27 patients experienced MACE (13.0%).
The long-term results of OPEN II show that the STENTYS-PES is safe and effective in the treatment of all-comers with coronary bifurcation lesions.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 06/2015; 11(2). DOI:10.4244/EIJY15M06_02 · 3.77 Impact Factor
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 05/2015; 11(V):V147-V148. DOI:10.4244/EIJV11SVA34 · 3.77 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The prognostic relevance of direct contrast toxicity in patients treated with transcatheter aortic valve implantation (TAVI) remains unclear because of the confounding hemodynamic effect of acute left ventricular ejection fraction (LVEF) impairment on kidney function estimation. In addition, different definitions of contrast-induced acute kidney injury (CI-AKI) may have different prognostic stratification potential. In the present study, 240 consecutive patients who underwent TAVI were prospectively enrolled. CI-AKI was defined (1) according to the postprocedural creatinine increase of ≥0.3 mg/dl or (2) according to the postprocedural decrease of the creatinine clearance of at least 25%. Primary end point of the study was 1-year all-cause mortality. At a mean follow-up of 1.7 ± 1.4 years, all-cause mortality was significantly higher in the CI-AKI patient group, using both CI-AKI definitions (for (1) and (2) p = 0.025 and p <0.001, respectively). In the Cox regression multivariate analysis, CI-AKI was an independent predictor of mortality (hazard ratio 2.244, 95% CI 1.064 to 4.732, p = 0.034), along with LVEF (hazard ratio 0.974, 95% CI 0.946 to 0.993, p = 0.012). Although LVEF and creatinine values at admission were not significantly associated with CI-AKI, their interaction term significantly defined CI-AKI (p = 0.033). The prognostic accuracy of definition (2) was higher (area under the curve 0.704; p <0.001) as with respect to definition (1) (area under the curve 0.602; p = 0.037) for the primary end point of 1-year mortality. In conclusion, in a nonselected patient population who underwent TAVI, CI-AKI was confirmed as an independent predictor of clinical outcome. Only the interaction between LVEF and baseline creatinine values was found to determine CI-AKI. Definition of CI-AKI based to creatinine clearance values had higher prognostic accuracy in comparison with the CI-AKI definition based on creatinine absolute value changes.
The American Journal of Cardiology 05/2015; 116(3). DOI:10.1016/j.amjcard.2015.04.056 · 3.28 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background/objectives:
Non-ST segment elevation myocardial infarction (MI) poses similar detrimental long-term prognosis as ST-segment elevation MI. No marker on ECG is established to predict successful reperfusion in NSTEMI. QT dispersion is increased by myocardial ischemia and reduced by successful restoration of epicardial blood flow by PCI. Whether QT dispersion reduction translates to smaller infarcts and thus indicates successful reperfusion is unknown. We hypothesized that the relative reduction of QT dispersion (QTD-Rrel ) on a standard ECG in acutely reperfused NSTEMI is related to infarct size and infarct transmurality as assessed by delayed enhancement CMR (DE-CMR).
Methods and results:
69 patients with a first acute NSTEMI were included. QTD-Rrel was stratified according to LV function and volumes, infarct transmurality and size as assessed by DE-CMR. Extensive myocardial infarction was defined as above median infarct size. LV function and end-systolic volume were only mildly related to QTD-Rrel . QTD-Rrel was inversely related to infarct size (r=-0.506,p=0.001) and infarct transmurality (r=-0.415, p=0.001). QTD-Rrel was associated with extensive myocardial infarction in univariate analysis (odds ratio (OR) 0.958, CI 0.935-0.982; p=0.001). Compared to clinical and angiographic data QTD-Rrel remained the only independent predictor of non-transmural infarcts (OR 1.110, CI 1.055-1.167; p=0.049).
In patients with acute Non-ST-Segment Myocardial infarction QTd-Rrel calculated on a surface ECG prior and post PCI for restoration of epicardial blood flow detects small, non-transmural infarcts as assessed by delayed enhancement CMR. Thus, QTd-Rrel can indicate successful reperfusion therapy.
International journal of medical sciences 05/2015; 12(5):378-386. DOI:10.7150/ijms.11224 · 2.00 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Aims: Next to patient characteristics, the lack of a standardised approach for bioresorbable vascular scaffold (BVS) implantation is perceived as a potential explanation for the heterogeneous results reported so far. To provide some guidance, we sought to find a consensus on the best practices for BVS implantation and management across a broad array of patient and lesion scenarios. Methods and results: Fourteen European centres with a high volume of BVS procedures combined their efforts in an informal collaboration. To get the most objective snapshot of different practices among the participating centres, a survey with 45 multiple choice questions was prepared and conducted. The results of the survey represented a basis for the technical advice provided in the document, whereas areas of controversy are highlighted. Conclusions: Consensus criteria for patient and lesion selection, BVS implantation and optimisation, use of intravascular imaging guidance, approach to multiple patient and lesion scenarios, and management of complications, were identified.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 01/2015; 10(10). DOI:10.4244/EIJY15M01_05 · 3.77 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Aims. To compare 30-day performance of three different type of transcatheter aortic valve implantation (TAVI) prosthesis: Direct Flow Medical (DFM), Medtronic Corevalve (MCV), and Edwards Sapien XT (ES).Methods and results. Forty consecutive patients treated with DFM for severe aortic stenosis were matched to an equal sample of patients undergoing TAVI with MCV and ES (1:1:1 propensity score-matching). Primary end-point was 30-day safety, defined according to the valve academic research consortium (VARC-2) criteria. Secondary end-points were: (i) immediate post-TAVI transaortic gradient reduction, (ii) device success and (iii) thirty-day mortality. Patients treated with DFM had higher 30-day safety rate compared to MCV and ES (respectively: 95.0% vs. 67.5% vs. 82.5%; p=0.006). Immediate post-TAVI transaortic gradient reduction was similar for DFM, MCV and ES subgroups (respectively: 8.3 ± 5.2 mmHg vs. 5.3 ± 3.7 mmHg vs. 5.6 ± 5.1 mmHg; p=0.15); likewise, device success did not differ significantly (respectively: 100% vs. 92.5% vs. 92.5%; p=0.19). Mortality rates were also similar (respectively: 0% vs. 7.5% vs. 7.5%; p=0.190). In the pooled binary logistic regression analysis blood transfusion was associated to 30-day safety (HR 0.156, 95%CI 0.049-0.500, p=0.002), while a significant trend was observed for the vascular closure device type (favoring Proglide vs. Prostar: HR 0.239, 95% CI 0.049 – 1.160, p=0.076).Conclusions. In high-risk patients with aortic stenosis undergoing TAVI, device success and short-term mortality were comparable between DFM, MCV and ES. In contrast, the 30-day VARC-defined safety primary end-point was met significantly more frequently in patients treated with DFM. This result was mainly driven by differences in major vascular complications, associated to differences in vascular closure devices between the different valve subgroups. This article is protected by copyright. All rights reserved.
[Show abstract][Hide abstract] ABSTRACT: Aims: Bioresorbable vascular scaffolds (BVS) have been available on the European market since November 2011. The ASSURE registry aims to investigate the safety and efficacy of the Absorb everolimus-eluting bioresorbable vascular scaffold in a real-world setting. Methods and results: Patients with de novo coronary artery disease were consecutively enrolled at six German centres in this prospective registry. Outcomes were procedural success, cardiovascular death, myocardial infarction, and ischaemia-driven target lesion revascularisation (TLR). Angiographic parameters were assessed quantitatively and visual estimates of lesion dimensions were studied. One hundred and eighty-three patients were treated. In 128 (64.7%) lesions a complex ACC/AHA morphology was present. Procedural success was achieved in all patients. Acute gain was 1.54±0.51 mm, resulting in a final minimal lumen diameter (MLD), which met the baseline reference vessel diameter (RVD), although visual estimates overrated the RVD by 0.5±0.5 mm. Up to 12 months, one patient (0.5%) had died from gastrointestinal bleeding, three (1.7%) non-target vessel myocardial infarctions occurred, and five (2.8%) TLR had become necessary because of restenosis. Conclusions: One-year results suggest that bioresorbable vascular scaffolds for de novo coronary artery disease are associated with favourable clinical and functional outcomes in routine clinical practice despite a visually overestimated RVD.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 12/2014; 11(2). DOI:10.4244/EIJY14M12_10 · 3.77 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: -Biodegradable-polymer drug-eluting stents (BP-DES) were developed to be as effective as second-generation durable-polymer drug-eluting stents (DP-DES) and as safe >1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should no longer appear.
-To address these early and late aspects, 2291 patients presenting with acute or stable coronary disease needing stents ≥3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9-eluting BP-DES, second-generation everolimus-eluting DP-DES, or thin-strut silicon-carbide-coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute risk difference, 0.78%; -1.93% to 3.50%; P for noninferiority 0.042; per protocol P=0.09) and superior to BMS (absolute risk difference, -5.16; -8.32 to -2.01; P=0.0011). The 3 stent groups did not differ in the combined safety end point, with no decrease in events >1 year, particularly VLST with BP-DES.
-In large vessel stenting, BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS, but without evidence for better safety nor lower VLST rates >1 year. Findings challenge the concept that durable polymers are key in VLST formation. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01166685.
[Show abstract][Hide abstract] ABSTRACT: Aims: Clinical data on the early and midterm outcomes of bioresorbable vascular scaffolds (BVS) in routine clinical practice are limited. To fill this gap, we report on the early and midterm clinical outcomes of PCI with everolimus-eluting BVS from the large multicentre GHOST-EU registry. Methods and results: Between November 2011 and January 2014, 1,189 patients underwent percutaneous coronary intervention with one or more BVS (Absorb BVS; Abbott Vascular, Santa Clara, CA, USA) at 10 European centres. The primary outcome of interest was target lesion failure (TLF), defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularisation (TLR). A total of 1,731 Absorb BVS were implanted at a mean of 12.3±3.4 atm. Technical success was achieved in 99.7% of cases. TLF was recorded in 67 of 1,189 patients at a median of 109 (interquartile range 8-227) days after implantation. The cumulative incidence of TLF was 2.2% at 30 days and 4.4% at six months. The annualised rate of TLF was 10.1%. At six months, the rate of cardiac death was 1.0%, target vessel myocardial infarction was 2.0%, TLR was 2.5%, and target vessel revascularisation was 4.0%. Diabetes mellitus was the only independent predictor of TLF (hazard ratio 2.41, 95% confidence interval: 1.28-4.53; p=0.006). The cumulative incidence of definite/probable scaffold thrombosis was 1.5% at 30 days and 2.1% at six months, with 16 of 23 cases occurring within 30 days. Conclusions: "Real-world" outcomes of BVS showed acceptable rates of TLF at six months, although the rates of early and midterm scaffold thrombosis, mostly clustered within 30 days, were not negligible.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 07/2014; 10(11). DOI:10.4244/EIJY14M07_11 · 3.77 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Every year, the EAPCI Board invites presidents and representatives of the interventional working groups affiliated to EAPCI to discuss issues and strategies surrounding the goals of education and advanced healthcare practices in inter-ventional cardiology. In 2013, the 2nd EAPCI Summit, organised by the EAPCI Board in collaboration with the NIFYI committee, was entirely dedicated to discussing the unmet needs of the young generation of interventional cardiologists. In this article, we highlight a selection of the key points and proposed actions highlighted during the summit.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 05/2014; 10(1):47-9. DOI:10.4244/EIJV10I1A9 · 3.77 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The purpose of this study was to determine whether the clinical presentation of lead-associated endocarditis (LAE) is related to the size of lead vegetations and how size is related to bacteriology and clinical outcomes.
Cardiac implantable electronic device (CIED) infection may present as either local pocket infection or bloodstream infection with or without LAE. LAE is associated with significant morbidity and mortality.
The clinical presentation and course of LAE were evaluated by the MEDIC (Multicenter Electrophysiologic Device Cohort) registry, an international registry enrolling patients with CIED infection. Consecutive LAE patients enrolled in the MEDIC registry between January 1, 2009 and December 31, 2012 were analyzed. The clinical features and outcomes of 2 groups of patients were compared based on the size of the lead vegetation detected by echocardiography (> or <1 cm in diameter).
There were 129 patients with LAE enrolled into the MEDIC registry. Of these, 61 patients had a vegetation <1 cm in diameter (Group I) whereas 68 patients had a vegetation ≥1 cm in diameter (Group II). Patients in Group I more often presented with signs of local pocket infection, whereas Group II patients presented with clinical evidence of systemic infection. Staphylococcus aureus was the organism most often responsible for LAE, whereas infection with coagulase-negative staphylococci was associated with larger vegetations. Outcomes were improved among those who underwent complete device removal. However, major complications were associated with an open surgical approach for device removal.
The clinical presentation of LAE is influenced by the size of the lead vegetation. Prompt recognition and management of LAE depends on obtaining blood cultures and echocardiography, including transesophageal echocardiography, in CIED patients who present with either signs of local pocket or systemic infection.