[Show abstract][Hide abstract] ABSTRACT: Background:
Third-generation drug-eluting metal stents are the gold standard for treatment of coronary artery disease. The permanent metallic caging of the vessel, however, can result in limited vasomotion, chronic inflammation, and late expansive remodeling, conditions that can lead to late and very late stent thrombosis. The development of bioresorbable scaffolds (BRSs) promises advantages over metal stents due to complete biodegradation within 2-4years. Theoretically, since vessel scaffolding is temporary and no permanent implant remains in the vessel, BRSs, as opposed to metal stents, once degraded would no longer be potential triggers for stent-related adverse events or side effects.
The short- and long-term outcome after implantation of an everolimus-eluting, poly-L-lactic acid-based bioresorbable scaffold system (ABSORB, Abbott Vascular, Santa Clara, CA, USA) in the world-wide greatest all-comers cohort will be evaluated in the prospective, non-interventional, multicenter German-Austrian ABSORB RegIstRy (GABI-R). GABI-R will include over 5000 patients from about 100 study sites in Austria and Germany. Safety endpoints such as cardiac death, myocardial infarction, and clinically driven percutaneous or surgical target lesion and vessel revascularization will be evaluated during hospitalization and in the follow-up period (minimum of 5years).
Although two randomized controlled trials and several registries have documented safety and efficacy as well as non-inferiority of this everolimus-eluting ABSORB device compared with drug-eluting metal stents, the current knowledge regarding clinical application, treatment success, and long-term safety of using this BRS in daily routine is limited. Thus, the goal of GABI-R is to address this lack of information.
Cardiovascular revascularization medicine: including molecular interventions 10/2015; DOI:10.1016/j.carrev.2015.09.002
[Show abstract][Hide abstract] ABSTRACT: Data about the impact of thrombectomy in primary percutaneous coronary intervention (PCI) are inconsistent. The aim of our study was an evaluation of both the real-world use of thrombectomy and the impact of thrombectomy on outcome in unselected patients treated with primary PCI for ST-elevation myocardial infarction (STEMI).
We used the data of the prospective ALKK PCI-registry of 35 hospitals from January 2010 to December 2013. A total of 10,755 patients receiving single-vessel primary PCI for acute STEMI were included. In 2176 patients (20.2 %) thrombectomy was performed. There was a wide range of use of thrombectomy in the different ALKK hospitals from 1.1 to 61.7 % (median 18.6 %, quartiles 6.0 and 40.3 %) with a general increase of use over the first years of the study period. In patients with and without thrombectomy there was TIMI 0 flow present before PCI in 6010 patients, TIMI 1 in 1338, TIMI 2 in 2002, and TIMI 3 in 1405. Patients with acute heart failure or cardiogenic shock received significantly more often thrombectomy. Fluoroscopy time (8.1 vs. 7.3 min, p < 0.0001) and dose area product (5373 cGy × cm(2) vs. 4802 cGy × cm(2), p < 0.0001) were significantly higher in patients treated with thrombectomy. The subgroup of patients with TIMI 0 flow before PCI had significantly higher rates of TIMI 3 flow after PCI when treated with thrombectomy (87.1 vs. 84.1 %, p < 0.01), while there was no difference in post-PCI TIMI 3 flow in patients with TIMI 1, 2 or 3 flow before PCI. Rates of major adverse cardiac and cerebrovascular events were similar in both groups in general and in all subgroups of TIMI flow.
The use of thrombectomy in patients with STEMI is heterogenous between hospitals. Overall, there was no impact of thrombectomy on TIMI 3 patency or mortality after PCI. In the subgroup of STEMI patients with TIMI 0 flow before PCI individualized thrombectomy had a positive impact on restoration of normal blood flow.
Clinical Research in Cardiology 03/2015; 104(10). DOI:10.1007/s00392-015-0846-z · 4.56 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background: We sought to identify prognostic factors of long-term mortality, specific for the underlying etiology of chronic systolic heart failure (CHF). Methods and results: Between 1995 and 2009 baseline characteristics, treatment and follow-up data from 2318 CHF-patients due to ischemic (ICM; 1100 patients) or dilated cardiomyopathy (DCM; 1218 patients) were prospectively compared. To calculate hazard ratios with 95%-confidence intervals cox regression was used. We respectively established etiology-specific multivariable models of independent prognostic factors. During the follow-up period of up to 14.8. years (mean. = 53.1. ±. 43.5. months; 10,264 patient-years) 991 deaths (42.8%) occurred.In the ICM-cohort, 5-year-survival was 53.4% (95% CI: 49.9-56.7%), whereas in DCM-patients it was higher (68.1% (95% CI: 65.1-71.0%)). Age, ejection fraction, or hyponatremia were independent predictors for mortality in both cohorts, whereas diabetes, COPD, atrial fibrillation and a heart rate of ≥. 80/min carried independent predictive power only in ICM-patients. Conclusion: This study demonstrates the disparity of prognostic value of clinically derived risk factors between the two main causes of CHF. The effects of covariables in DCM-patients were lower, suggesting a less modifiable disease through risk factors considering mortality risk. An etiology-specific prognostic model may improve accuracy of survival estimations in CHF.
[Show abstract][Hide abstract] ABSTRACT: There is information suggesting differences and underuse of invasive coronary diagnostic and therapeutic procedures in women compared to men.
Data from consecutive patients (pts) which were enrolled in the Coronary Angiography and PCI Registry of the German Society of Cardiology were analyzed. We compared gender-related differences in diagnosis and therapeutic recommendation of pts undergoing coronary angiography (XA) for stable coronary artery disease (CAD), non-ST elevation acute coronary syndromes (NSTE-ACS) and ST elevation myocardial infarction (STEMI).
From 2004 until the end of 2009, data of 1,060,542 invasive procedures in 1,014,996 pts were prospectively registered. One-third (34.6 %) of them were female. Women less often had significant CAD, irrespective of the indication for XA. In pts with relevant CAD, percutaneous coronary interventions (PCI) were recommended in 87.1 % of women versus 89.1 % of men with STEMI [age-adjusted OR (aOR) 0.98, 95 % CI 0.93-1.04], in 67.1 vs. 66.8 % in NSTE-ACS (aOR 1.10, 1.07-1.12), and in 50.3 vs 49.4 % in stable CAD (aOR 1.07, 1.05-1.09).
In pts with significant CAD, there was no difference in recommendation for PCI between the genders in stable CAD, whereas in STEMI and NSTE-ACS women were treated even more often with PCI. There were only minor differences in referral for CABG between women and men. Hence, our data provide strong evidence against a gender bias in use of invasive therapeutic procedures once the diagnosis of significant CAD has been confirmed.
Clinical Research in Cardiology 01/2015; 104(6). DOI:10.1007/s00392-015-0815-6 · 4.56 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The study analyses the outcome of patients undergoing transcatheter aortic valve implantation (TAVI) for different subtypes of severe aortic stenosis (AS) based on data from the GARY registry.
Low-EF, low-gradient (LEF-LGAS: EF ≤40%, MPG <40 mmHg), paradoxical low-gradient (PLF-LGAS: EF ≥50%, MPG <40 mmHg) and high-gradient AS (HGAS: MPG ≥40 mmHg) were observed in 11.7% (n=359), 20.8% (n=640) and 60.6% (n=1,864) of the study population, respectively. EuroSCORE I (36.7±20.9 vs. 22.6±15.7 vs. 24.3±17.4; p<0.001) differed significantly among subgroups. In-hospital and one-year mortality were higher in patients with LEF-LGAS compared to HGAS (in-hospital: 7.8% vs. 4.9%; p=0.029; one-year: 32.3% vs. 19.8%; p=0.001). In contrast, mortality in patients with PLF-LGAS was comparable to patients with HGAS (in-hospital: PLF-LGAS: 5.3%; p=0.67; one-year: 22.3%; p=0.192). The rate of TAVI-associated complications was not significantly different among groups. However, postoperative low cardiac output occurred significantly more frequently in patients with LEF-LGAS Conclusions: Severe AS with a reduced transaortic flow and gradient is a common finding and is present in >30% of patients undergoing TAVI. Patients with low flow and impaired LV function have a significantly higher mortality within the first year after TAVI. In contrast, the outcome of patients with low flow and preserved EF is comparable to those with a high transvalvular aortic gradient.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 11/2014; 10(7):850-9. DOI:10.4244/EIJV10I7A145 · 3.77 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Aims:
We performed a prospective multi-center study to assess gender-specific differences in the predictive value of the measured level of NT-proBNP and the calculated Heart Failure Survival Score (HFSS).
Baseline characteristics and follow-up data up to 5 years from 2,019 men and 530 women diagnosed with chronic heart failure (CHF) due to ischemic heart disease or dilated cardiomyopathy were prospectively compared. Death from any cause constituted the endpoint of the study. NT-proBNP was measured and HFSS calculated according to standard methods. Survival of men and women according to level of NT-proBNP and HFSS was analyzed in logistic regression models.
Median NT-proBNP level in men was 1,394 ng/l (IQR 516-3,406 ng/l) and 1,168 ng/l (IQR 444-2,830 ng/l) in women (p = n.s.). Median HFSS value was 8.4 (IQR 7.7-9.1) and 8.5 (8.0-9.1) in men and women, respectively. NT-proBNP levels and HFSS score correlated well with survival rates in both genders (p for interaction = 0.22 for NT-proBNP and 0.93 for HFSS). The all-cause death rates were similar in men and women.
Despite a number of gender-specific differences in CHF and the general predominance of men measured levels of NT-proBNP and HFSS score can be utilized for risk stratification with similar informative value in men and women.
Clinical Research in Cardiology 11/2014; 104(4). DOI:10.1007/s00392-014-0786-z · 4.56 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This study compared the timing of onset of antiplatelet action after treatment with clopidogrel and prasugrel at first medical contact in patients with ST segment elevation myocardial infarction (STEMI) scheduled for primary percutaneous coronary intervention (PPCI).Background
Little is known about the timing of onset of antiplatelet action after a pre-PCI loading dose of clopidogrel or prasugrel in patients with STEMI.Methods
This double-blind prospective study randomized 62 patients with STEMI scheduled for PPCI in the ambulance or the emergency department to 60 mg prasugrel (n=31) or 600 mg clopidogrel (n=31). The primary endpoint was the platetet reactivity index (PRI) measured with the VASP assay 2 hours after intake of the study medication. Secondary endpoints were PRI after 4 hours, TIMI patency of the infarct related artery before and after PCI and clinical events until day 30.ResultsThe PRI after 2 hours (50.4+ 32.7 % versus 66.3 + 22.2 %; p = 0.035) and after 4 hours (39.1+ 27.5 % versus 54.5+ 49.3 %; p = 0.038) were significantly lower with prasugrel compared to clopidogrel. In addition the rate of patients with a PRI < 50% tended to be higher with prasugrel compared to clopidogrel after 2 hours (46.7% versus 28.6%, p=0.15) and after 4 hours (63.0% versus 38.9%, 0=0.06). There were no significant differences in TIMI 2/3 patency before PCI (39.2% versus 31.0%, p=0.43) and TIMI 3 patency after PCI (88.5% versus 89.3%, p=0.92), respectively.Conclusions
The pre-PCI administration of prasugrel in patients with STEMI undergoing PPCI was associated with a significant faster platelet inhibition compared to clopidogrel. Therefore prasugrel should be preferred to clopidogrel in this setting.
[Show abstract][Hide abstract] ABSTRACT: Aims: To analyse patient characteristics, decision-making processes, and outcomes of TAVI performed in hospitals with versus those without on-site cardiac surgery (CS). Methods and results: Current guidelines mandate transcatheter aortic valve implantation (TAVI) to be performed at hospitals with both cardiology and on-site CS departments. Some hospitals in Germany perform TAVI without CS departments in-house. We analysed the data of 1,432 patients enrolled in the German TAVI registry at 27 hospitals between January 2009 and June 2010. Nineteen of these had on-site CS (group 1), while eight centres performed TAVI with no CS depai tment at their institution (group 2). Patients in group 2 (n=178, 12% of the overall study population) were older than in group 1 (mean age 82.6 6.3 years vs. 81.6 6.2 years) with similar logistic EuroSCORE (average: 21%). Patients in group 2 were haemodynamically more stable (higher blood pressures, better ejection fraction, less low-flow or low-gradient aortic stenosis, and less urgent procedures). Procedure times and use of contrast were higher in group 2. The procedural success rate was higher in group 1 (98% vs. 95%). Post-procedural complications were similar in the two groups with 30-day mortality of 6.2% in group 2 compared with 8.3% in group 1 patients. Conclusions: Only 12% of patients enrolled in the German TAVI registry underwent TAVI at hospitals without an on-site CS department. Overall patient characteristics appeared to be similar, although patients in non-CS centres appeared to be haemodynamically more stable and more often had a history of previous heart surgery. Despite longer procedures, complication rates were similar. These preliminary data in a modest number of patients suggest the feasibility of performing TAVI in appropriately selected patients at hospitals without CS but this requires confirmation in future studies involving a large number of patients.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 09/2014; 10(5):602-8. DOI:10.4244/EIJV10I5A105 · 3.77 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Aims: Current guidelines recommend immediate multivessel percutaneous coronary intervention (PCI) in patients with cardiogenic shock, despite the lack of randomised trials. We sought to investigate the use and impact on outcome of multivessel PCI in current practice in cardiogenic shock in Germany. Methods and results: Between January 2008 and December 2011 a total of 735 consecutive patients with acute myocardial infarction, cardiogenic shock and multivessel coronary artery disease underwent immediate PCI in 41 hospitals in Germany. Of these, 173 (23.5%) patients were treated with immediate multivessel PCI. The acute success of PCI with respect to TIMI 3 flow did not differ between the groups (82.5% versus 79.6%). In-hospital mortality with multivessel PCI and culprit lesion PCI was 46.8% and 35.8%, respectively. In multivariate analysis multivessel PCI was associated with an increased mortality (odds ratio 1.5; 95% confidence interval 1.15-1.84). Conclusions: In current clinical practice in Germany multivessel PCI is used only in one quarter of patients with cardiogenic shock treated with primary PCI. We observed an adverse effect of immediate multivessel PCI. Therefore, a randomised trial is needed to determine the definitive role of multivessel PCI in cardiogenic shock.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 08/2014; 11(3). DOI:10.4244/EIJY14M08_04 · 3.77 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objectives:
The German Aortic Valve Registry (GARY) seeks to provide information on a real-world, all-comers basis for patients undergoing aortic valve interventions. This registry comprises patients undergoing the complete spectrum of transcutaneous and conventional surgical aortic valve interventions. The aim of this study was to use the GARY registry to evaluate conventional and catheter-based aortic valve interventions in several risk groups.
A total of 13 860 consecutive patients undergoing intervention for aortic valve disease [conventional aortic valve replacement (AVR) or transvascular/transapical TAVR (TV-/TA-TAVR)] were enrolled in 78 German centres in 2011. Baseline, procedural and outcome data, including quality of life, were acquired up to 1 year post-intervention. Vital status at 1 year was known for 98.1% of patients.
The 1-year mortality rate was 6.7% for conventional AVR patients (n = 6523) and 11.0% for patients who underwent AVR with coronary artery bypass grafting (n = 3464). The 1-year mortality rate was 20.7 and 28.0% in TV- and TA-TAVR patients, respectively (n = 2695 and 1181). However, if patients were stratified into four risk groups by means of the EuroSCORE and the German AV Score, the highest risk cohorts showed the same mortality at 1 year with either therapy. More than 80% of patients in all groups were in the same or better state of health at 1 year post-intervention and were satisfied with the procedural outcome.
Conventional AVR surgery yields excellent results after 1 year in lower-risk patients. Catheter-based AVR is a good alternative in high-risk and elderly patients.
European journal of cardio-thoracic surgery: official journal of the European Association for Cardio-thoracic Surgery 07/2014; 46(5). DOI:10.1093/ejcts/ezu290 · 3.30 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objective:
Residual aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) has been associated with increased mortality. Nevertheless, a considerable proportion of these patients survives and appears to tolerate AR. Identification of patients at higher risk of death may assist in tailoring therapy, but predictors of mortality in this subset of patients is largely unknown.
A total of 1432 patients were included in the German TAVI registry. One-year follow-up data were available for 1318 patients (92%). Of the latter, 201 patients (15.2%) had more-than-mild AR as evaluated by angiography and represent the population of the current analysis. Among these patients, baseline demographic, clinical, echocardiographic and angiographic characteristics were compared among survivors and non-survivors to identify factors associated with mortality at 1 year.
Mean age was 81.2±6.6 years and men represented 55%. The mean logistic EuroSCORE was 22±15%. Overall, 92% of patients received the Medtronic CoreValve and 8% received the Edwards Sapien valve. At 1 year, 61 patients (31%) with more-than-mild post-TAVI AR had died. Compared with patients who survived, patients who died had more commonly coronary artery disease, peripheral arterial disease and chronic renal impairment. Patients who died had a lower baseline LVEF (44±18% vs 52±16%, p=0.002), higher prevalence of more-than-mild (≥2+) mitral regurgitation (44% vs 27%, p=0.001), and a higher systolic pulmonary artery pressure (51±18 mm Hg vs 44±19 mm Hg, p=0.002), but the severity of aortic stenosis was similar, and the prevalence and severity of pre-TAVI AR was comparable (any AR in 88% vs 83%, respectively, p=0.29). Using Cox regression analysis, only baseline mitral regurgitation ≥2+ (HR 1.77, 95% CI 1.05 to 2.99, p=0.03) and systolic pulmonary artery pressure (HR 1.15, 95% CI 1.01 to 1.33, p=0.04) were independently associated with 1-year mortality, while female gender was protective (HR 0.54, 95% CI 0.30 to 0.96, p=0.03).
We identified preprocedural characteristics associated with 1-year mortality in patients with more-than-mild AR after TAVI. More-than-mild baseline mitral regurgitation, higher systolic pulmonary artery pressure and male gender were independently associated with worse outcome.