[Show abstract][Hide abstract] ABSTRACT: Cardiogenic shock (CS) complicating acute myocardial infarction (AMI) is associated with high mortality. Previous studies regarding gender-specific differences in CS are conflicting and there are insufficient data for the presence of gender-associated differences in the contemporary percutaneous coronary intervention era. Aim of this study was therefore to investigate gender-specific differences in a large cohort of AMI patients with CS undergoing contemporary treatment.
Clinical research in cardiology : official journal of the German Cardiac Society. 10/2014;
[Show abstract][Hide abstract] ABSTRACT: 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.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Mineralocorticoid antagonists improve survival among patients with chronic, severe systolic heart failure and heart failure after myocardial infarction. We evaluated the effects of eplerenone in patients with chronic systolic heart failure and mild symptoms. METHODS: In this randomized, double-blind trial, we randomly assigned 2737 patients with New York Heart Association class II heart failure and an ejection fraction of no more than 35% to receive eplerenone (up to 50 mg daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure. RESULTS: The trial was stopped prematurely, according to prespecified rules, after a median follow-up period of 21 months. The primary outcome occurred in 18.3% of patients in the eplerenone group as compared with 25.9% in the placebo group (hazard ratio, 0.63; 95% confidence interval [CI], 0.54 to 0.74; P<0.001). A total of 12.5% of patients receiving eplerenone and 15.5% of those receiving placebo died (hazard ratio, 0.76; 95% CI, 0.62 to 0.93; P=0.008); 10.8% and 13.5%, respectively, died of cardiovascular causes (hazard ratio, 0.76; 95% CI, 0.61 to 0.94; P=0.01). Hospitalizations for heart failure and for any cause were also reduced with eplerenone. A serum potassium level exceeding 5.5 mmol per liter occurred in 11.8% of patients in the eplerenone group and 7.2% of those in the placebo group (P<0.001). CONCLUSIONS: Eplerenone, as compared with placebo, reduced both the risk of death and the risk of hospitalization among patients with systolic heart failure and mild symptoms. (Funded by Pfizer; ClinicalTrials.gov number, NCT00232180.).
[Show abstract][Hide abstract] ABSTRACT: The aim of this analysis is to examine the influence of gender differences on the outcome after transcatheter aortic valve implantation (TAVI) from a multicenter real-world registry in Germany (TAVI registry).
The impact of gender differences on the clinical outcome after TAVI was examined in small studies with conflicting results.
Consecutive patients (n = 1,432) undergoing TAVI in the period between January 2009 and June 2010 in Germany were evaluated. Differences in all-cause mortality were examined with Kaplan-Meier estimates and proportional hazards models.
Women comprised 57.8 % of the cohort. The Edwards Sapien valve (18.5 %) and CoreValve (81.5 %) were used through the transfemoral (87.7 %), subclavian (3.0 %), transapical (8.6 %), or transaortic approach (0.7 %). At baseline, women had higher aortic gradients and were older. Men had more comorbidities: prior myocardial infarction, prior revascularization, prior coronary artery bypass surgery, peripheral arterial vascular disease and chronic obstructive pulmonary disease. Women had more periprocedural vascular complications in comparison to men (25.2 vs. 17.2 %, p < 0.001). There was no significant difference in mortality at 30-day follow-up (7.6 % for women vs. 8.6 % for men, p = 0.55). The adjusted HR for 1-year all-cause mortality favored women, HR 0.75 (95 % CI 0.57-0.98, p = 0.0346) with a mortality rate of 17.3 vs. 23.6 % for men.
Female gender is associated with better 1-year survival after TAVI. These results suggest that TAVI could be the best treatment modality for elderly women with symptomatic severe aortic stenosis.
Clinical Research in Cardiology 03/2014; · 3.67 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Die heute vorhandenen Therapieoptionen der koronaren Herzkrankheit (KHK) erfordern ein differenziertes, auf den einzelnen Patienten zugeschnittenes, therapeutisches Vorgehen. Grundlage der KHK-Therapie sind Lifestyle-Modifikationen, die je nach individuellem Risikoprofil des Patienten gezielte Schwerpunkte setzen. Die pharmakologische Therapie der KHK hat das Ziel, präventiv Sekundärereignisse zu verhindern (Thrombozytenaggregationshemmer, Statine) und abhängig vom Ausmaß der Beschwerden antianginös wirksam zu sein (kurzwirksame Nitrate, Betablocker, Kalziumantagonisten, ggf. Ivabradin, Ranolazin). Während bei akuten Koronarsyndromen eine umgehende Koronarrevaskularisation erforderlich ist, ist die Entscheidung zur Revaskularisation bei stabiler KHK von der Symptomatik, einer Ischämie-/Vitalitätsdiagnostik sowie ergänzenden invasiven Verfahren (fraktionelle Flussreserve, intravaskulärer Ultraschall) abhängig. Die Differenzialindikation perkutane Koronarintervention (PCI) versus aortokoronare Bypass-Operation orientiert sich insbesondere an Koronarstatus (SYNTAX-Score), Allgemeinzustand und Willen des Patienten. Die internationalen Leitlinien betonen dabei die Rolle einer interdisziplinären Therapieentscheidung im ,,Heart Team“. Insgesamt stellt die Differenzialtherapie der KHK heute ein herausforderndes Gebiet der Patientenversorgung dar, auf dem zukünftig noch viele weitere Entwicklungen zu erwarten sind.
[Show abstract][Hide abstract] ABSTRACT: The various contemporary therapeutic options for coronary artery disease (CAD) require differentiated, individualized treatment strategies. The foundations of CAD therapy are lifestyle modifications targeted on the individual risk profile of the patients. Pharmacological therapy of CAD should prevent secondary coronary events (e.g. platelet aggregation inhibitors and statins) and reduce angina in symptomatic patients (e.g. short-acting nitrates, beta blockers, calcium channel blockers and if necessary ivabradine and ranolazine). Revascularization therapy has to be performed promptly in patients with acute coronary syndromes; however, in patients with stable CAD the decision to perform revascularization therapy has to consider symptoms, detection of ischemia and if appropriate intracoronary assessment of hemodynamic relevance of an intermediate stenosis (fractional flow reserve). The differential indications of percutaneous coronary intervention compared to coronary artery bypass grafting depend on the severity of coronary artery disease and the morphology (SYNTAX score), comorbidities and the will of the individual patient. The international guidelines emphasize the value of an interdisciplinary treatment decision in a "heart team". In summary, differential therapy of CAD has become challenging in the current clinical practice; future developments will probably further improve individualized strategies to treat patients with CAD.
[Show abstract][Hide abstract] ABSTRACT: IMPORTANCE Myocardial ischemia in patients with stable coronary artery disease (CAD) has been repeatedly associated with impaired survival. However, it is unclear if revascularization with percutaneous coronary intervention (PCI) to relieve ischemia improves outcomes compared with medical therapy (MT). OBJECTIVE The objective of this study was to compare the effect of PCI and MT with MT alone exclusively in patients with stable CAD and objectively documented myocardial ischemia on clinical outcomes. DATA SOURCES MEDLINE, Cochrane, and PubMed databases from 1970 to November 2012. Unpublished data were obtained from investigators. STUDY SELECTION Randomized clinical trials of PCI and MT vs MT alone for stable coronary artery disease in which stents and statins were used in more than 50% of patients. DATA EXTRACTION For studies in which myocardial ischemia diagnosed by stress testing or fractional flow reserve was required for enrollment, descriptive and quantitative data were extracted from the published report. For studies in which myocardial ischemia was not a requirement for enrollment, authors provided data for only those patients with ischemia determined by stress testing prior to randomization. The outcomes analyzed included death from any cause, nonfatal myocardial infarction (MI), unplanned revascularization, and angina. Summary odds ratios (ORs) were obtained using a random-effects model. Heterogeneity was assessed using the Q statistic and I2. RESULTS In 5 trials enrolling 5286 patients, myocardial ischemia was diagnosed in 4064 patients by exercise stress testing, nuclear or echocardiographic stress imaging, or fractional flow reserve. Follow-up ranged from 231 days to 5 years (median, 5 years). The respective event rates for PCI with MT vs MT alone for death were 6.5% and 7.3% (OR, 0.90 [95% CI, 0.71-1.16); for nonfatal MI, 9.2% and 7.6% (OR, 1.24 [95% CI, 0.99-1.56]); for unplanned revascularization, 18.3% and 28.4% (OR, 0.64 [95% CI, 0.35-1.17); and for angina, 20.3% and 23.3% (OR, 0.91 [95% CI, 0.57-1.44]). CONCLUSIONS AND RELEVANCE In patients with stable CAD and objectively documented myocardial ischemia, PCI with MT was not associated with a reduction in death, nonfatal MI, unplanned revascularization, or angina compared with MT alone.
JAMA Internal Medicine 12/2013; · 13.25 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: In current international guidelines the recommendation for intra-aortic balloon pump (IABP) use has been downgraded in cardiogenic shock complicating acute myocardial infarction on the basis of registry data. In the largest randomised trial (IABP-SHOCK II), IABP support did not reduce 30 day mortality compared with control. However, previous trials in cardiogenic shock showed a mortality benefit only at extended follow-up. The present analysis therefore reports 6 and 12 month results.
The IABP-SHOCK II trial was a randomised, open-label, multicentre trial. Patients with cardiogenic shock complicating acute myocardial infarction who were undergoing early revascularisation and optimum medical therapy were randomly assigned (1:1) to IABP versus control via a central web-based system. The primary efficacy endpoint was 30 day all-cause mortality, but 6 and 12 month follow-up was done in addition to quality-of-life assessment for all survivors with the Euroqol-5D questionnaire. A masked central committee adjudicated clinical outcomes. Patients and investigators were not masked to treatment allocation. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00491036.
Between June 16, 2009, and March 3, 2012, 600 patients were assigned to IABP (n=301) or control (n=299). Of 595 patients completing 12 month follow-up, 155 (52%) of 299 patients in the IABP group and 152 (51%) of 296 patients in the control group had died (relative risk [RR] 1·01, 95% CI 0·86-1·18, p=0·91). There were no significant differences in reinfarction (RR 2·60, 95% CI 0·95-7·10, p=0·05), recurrent revascularisation (0·91, 0·58-1·41, p=0·77), or stroke (1·50, 0·25-8·84, p=1·00). For survivors, quality-of-life measures including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression did not differ significantly between study groups.
In patients undergoing early revascularisation for myocardial infarction complicated by cardiogenic shock, IABP did not reduce 12 month all-cause mortality.
German Research Foundation; German Heart Research Foundation; German Cardiac Society; Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte; University of Leipzig-Heart Centre; Maquet Cardiopulmonary; Teleflex Medical.
The Lancet 11/2013; 382(9905):1638-1645. · 39.21 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Patients with bicuspid aortic valves (BAVs) are considered a relative contraindication to transcatheter aortic valve implantation (TAVI). One of the main reasons is the presumed risk for residual aortic regurgitation (AR). However, case reports and small case series have suggested that TAVI can be successfully performed with acceptable clinical outcomes in high-risk patients with BAV. Within the large German TAVI Registry, we sought to evaluate TAVI in older high-risk patients with BAV. From January 2009 to June 2010, a total of 1,424 patients with severe aortic stenosis undergoing TAVI were prospectively enrolled into the German TAVI Registry. For the present analysis, patients with valve-in-valve procedures were excluded and those with BAV (n = 38, 3%) were compared with those with tricuspid aortic valve (TAV; n = 1357, 97%). Patient characteristics did not markedly differ and procedural success was very high in both groups. There was a higher rate of relevant AR (≥II) after TAVI among patients with BAV (25 vs 15%, p = 0.05), whereas pacemakers were more often implanted in patients with TAV (17% vs 35%, p = 0.02). Thirty-day mortality rate was similar in both cohorts (11% vs 11%). In a Cox proportional regression analysis, BAV was not associated with higher 1-year mortality rate (hazard ratio 0.64, 95% confidence interval 0.29 to 1.41). In selected patients with BAV, TAVI can be performed with a satisfactory clinical result. Although the risk for relevant AR seems to be greater among patients with BAV, 30-day and 1-year mortality rates were not elevated compared with patients with TAV.
The American journal of cardiology 11/2013; · 3.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Rationale: HDL exerts endothelial-protective effects via stimulation of endothelial cell (EC) NO production. This function is impaired in patients with cardiovascular disease. Protective effects of exercise training (ET) on endothelial function have been demonstrated Objective: This study was performed to evaluate the impact of ET on HDL-mediated protective effects and the respective molecular pathways in patients with chronic heart failure (CHF). Methods and Results: HDL was isolated from 16 healthy controls (HDLhealthy) and 16 patients with CHF-NYHA-III (HDLNYHA-IIIb) before and after ET, and 8 patients with CHF-NYHA-II (HDLNYHA-II). EC were incubated with HDL and phosphorylation of eNOS-Ser(1177), eNOS-Thr(495), PKC-ßII-Ser(660) and p70S6K-Ser(411) was evaluated. HDL-bound malondialdehyde and HDL-induced NO production by EC were quantified. Endothelial function was assessed by flow-mediated dilatation (FMD). The proteome of HDL particles was profiled by shotgun LC-MS/MS. Incubation of EC with HDLNYHA-IIIb triggered a lower stimulation of phosphorylation at eNOS-Ser(1177) and a higher phosphorylation at eNOS-Thr(495) when compared to HDLhealthy. This was associated with lower NO production of EC. In addition an elevated activation of p70S6K, PKC-ßII by HDLNYHA-IIIb, and a higher amount of malondialdehyde bound to HDLNYHA-IIIb compared to HDLhealthy was measured. In healthy individuals ET had no effect on HDL function, whereas ET of CHF-NYHA-IIIB significantly improved HDL function. A correlation between changes in HDL-induced NO production and FMD improvement by ET was evident. Conclusions: These results demonstrate that HDL-function is impaired in CHF and that ET improved the HDL-mediated vascular effects. This may be one mechanism how ET exerts beneficial effects in CHF.
Circulation Research 09/2013; · 11.86 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background and objective: The goal of treatment of patients with ST-segment elevation acute myocardial infarction (STEMI) is to restore perfusion as soon as possible, preferably by primary percutaneous coronary intervention (PCI). The aim of this study of the German Myocardial Infarction Registry (DHR) was to document acute care and in-hospital course of STEMI patients in GermanyMethods: Over three months patients with STEMI were consecutively included and their basic data, treatments and in-hospital complications were centrally recorded using an internet-based standardized questionnaire.Results: Included were 6,330 patients from 243 hospitals, in group 1 (primary admission in 136 hospitals with cath lab) 4,656 patients (74 %) and in group 2 (primary admission in 107 hospitals without cath lab) 1,674 (26 %). Reperfusion therapy was performed more frequently in patients of group 1 (91.1 % PCI, 2.7 % fibrinolysis) than in group 2 (80.7 % PCI after transfer, 6.4 % fibrinolysis). In-hospital mortality was 7.3 % in all patients, 7.0 % in group 1 and 8.3 % in group 2.Conclusion: The DHR data show that about three quarters of patients with STEMI are primarily admitted to hospitals with cath labs. Primary PCI is the preferred treatment option both in hospitals with and without cath labs (in the latter after transfer); it is performed in about 85 % of STEMI patients. In-hospital mortality is with over 7 % higher in real-life than in randomized studies.
[Show abstract][Hide abstract] ABSTRACT: Aims: To evaluate: 1) the causes of emergency conversion from transcatheter aortic valve implantation (TAVI) to surgery, 2) procedural settings, and 3) short-term outcome of converted patients. Methods and results: The prospective German TAVI registry was used to identify patients who underwent bail-out surgery during TAVI. Additionally, standardised questionnaires were developed and used to assess more detailed periprocedural and postprocedural data. Emergency conversion from TAVI to open cardiac surgery was required in 24 of 1,975 patients (1.2%). Primary conversion causes were aorto-valvular complications (i.e., aortic annulus rupture, aortic perforation, or thoracic aortic dissection). This was followed by prosthesis embolisation, myocardial perforation, severe aortic regurgitation, and coronary obstructions. The mean time interval between abortions of TAVI to surgery was 19 minutes (SD±17 min, range 5-80 min). Four of 24 patients (16.7%) died during the initial surgery, seven of 24 (29.2%) within the first 72 hours and the 30-day mortality was 45.8%. The highest mortality was observed in patients with aortic perforation or dissection (4/5, 80%). Mortality rates for other entities were: prosthesis embolisation 40% (2/5), myocardial perforation 50% (2/4), annulus rupture 67% (2/3), severe aortic regurgitation 33% (1/3), and coronary impairment 0% (0/3). Conclusions: Emergency conversion from TAVI to surgery is a rare event carrying a mortality of around 45% after 30 days. Outcome of converted patients with prior injury of aortic, aorto-valvular, or myocardial tissue during TAVI was poor, whereas patients with severe aortic regurgitation and those with coronary complications had a more favourable outcome after 30 days. Collected procedural and outcome data demand on-site cardiac surgery as a prerequisite for TAVI and constant process optimisation efforts regarding such emergency scenarios.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 08/2013; 9(4):446-51. · 3.17 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: INTRODUCTION: Laws banning tobacco smoking from public areas have been passed in several countries, including the region of Bremen, Germany at the end of 2007. The present study analyses the incidence of hospital admissions due to ST-elevation myocardial infarctions (STEMIs) before and after such a smoking ban was implemented, focusing on differences between smokers and non-smokers. In this respect, data of the Bremen STEMI Registry (BSR) give a complete epidemiological overview of a region in northwest Germany with approximately 800,000 inhabitants since all STEMIs are admitted to one central heart centre. METHODS AND RESULTS: Between January 2006 and December 2010, data from the BSR was analysed focusing on date of admission, age, gender, and prior nicotine consumption. A total of 3545 patients with STEMI were admitted in the Bremen Heart Centre during this time period. Comparing 2006-2007 vs. 2008-2010, hence before and after the smoking ban, a 16% decrease of the number of STEMIs was observed: from a mean of 65 STEMI/month in 2006-2007 to 55/month in 2008-2010 (p < 0.01). The group of smokers showed a constant number of STEMIs: 25/month in 2006-2007 to 26/month in 2008-2010 (+4%, p = 0.8). However, in non-smokers, a significant reduction of STEMIs over time was found: 39/month in 2006-2007 to 29/month in 2008-2010 (-26%, p < 0.01). The decline of STEMIs in non-smokers was consistently observed in all age groups and both sexes. Adjusting for potentially confounding factors like hypertension, obesity, and diabetes mellitus did not explain the observed decline. CONCLUSIONS: In the BSR, a significant decline of hospital admissions due to STEMIs in non-smokers was observed after the smoking ban in public areas came into force. No reduction of STEMI-related admissions was found in smokers. These results may be explained by the protection of non-smokers from passive smoking and the absence of such an effect in smokers by the dominant effect of active smoking.
European journal of preventive cardiology. 04/2013;
[Show abstract][Hide abstract] ABSTRACT: Transcatheter aortic valve implantation (TAVI) is already an accepted option to treat elderly patients with severe symptomatic aortic stenosis who are inoperable or at high surgical risk. However, short- and long-term mortality after TAVI remains an important issue, raising the need to further improve the technology of TAVI as well as to identify patients who will not benefit from TAVI. A total of 1,391 patients treated with TAVI at 27 hospitals were included in the German Transcatheter Aortic Valve Interventions - Registry. One-year follow-up data were available for 1,318 patients (94.8%), with a mean follow-up period of 12.9 ± 4.5 months. One-year mortality was 19.9%. Survivors and nonsurvivors showed multiple differences in patient characteristics, indications for interventions, preintervention and interventional characteristics, and postintervention events. A higher logistic European System for Cardiac Operative Risk Evaluation score was associated with higher 1-year mortality (p <0.0001). Cox proportional-hazards analysis revealed the following independent predictors of mortality: among preintervention findings: previous mitral insufficiency ≥II° (p = 0.0005), low-gradient aortic stenosis (p = 0.0008), previous decompensation (p = 0.0061), previous myocardial infarction (p = 0.0138), renal failure (p = 0.0180), previous New York Heart Association class IV (p = 0.0254), and female gender (p = 0.0346); among procedural factors: intraprocedural conversion to surgery (p = 0.0009), peri-intervention stroke (p = 0.0003), and residual aortic insufficiency ≥II° (p = 0.0022); and among postprocedural events: postintervention myocardial infarction (p = 0.0009) and postintervention pulmonary embolism (p = 0.0025). In conclusion, 1-year mortality after TAVI was 19.9% in this series. Patient characteristics and procedural as well as postintervention factors associated with mortality were identified, which may allow better patient selection and better care for these critically ill patients.
The American journal of cardiology 04/2013; · 3.58 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The beneficial effects of physical exercise on stable coronary artery disease (CAD) have been shown by an increasing number of studies. Exercise training leads to an improved bioavailability of the endothelial nitric oxide and partially attenuates endothelial dysfunction. Further effects are an economization of ventricular function and a reduction of cardiovascular risk factors. In clinical studies exercise training was associated with a decreased total and cardiovascular mortality and a reduced angina pectoris threshold. Thus exercise training has developed to an evidence-based therapeutic option of stable CAD with a Class Ia recommendation in the guidelines.
Current Opinion in Pharmacology 01/2013; · 5.44 Impact Factor