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Bad Berka, Germany

Thiele H.,University of Leipzig | Zeymer U.,Institute For Herzinfarktforschung | Neumann F.-J.,Heart Center Bad Krozingen | Ferenc M.,Heart Center Bad Krozingen | And 15 more authors.
New England Journal of Medicine

BACKGROUND: In current international guidelines, intraaortic balloon counterpulsation is considered to be a class I treatment for cardiogenic shock complicating acute myocardial infarction. However, evidence is based mainly on registry data, and there is a paucity of randomized clinical trials. METHODS: In this randomized, prospective, open-label, multicenter trial, we randomly assigned 600 patients with cardiogenic shock complicating acute myocardial infarction to intraaortic balloon counterpulsation (IABP group, 301 patients) or no intraaortic balloon counterpulsation (control group, 299 patients). All patients were expected to undergo early revascularization (by means of percutaneous coronary intervention or bypass surgery) and to receive the best available medical therapy. The primary efficacy end point was 30-day all-cause mortality. Safety assessments included major bleeding, peripheral ischemic complications, sepsis, and stroke. RESULTS: A total of 300 patients in the IABP group and 298 in the control group were included in the analysis of the primary end point. At 30 days, 119 patients in the IABP group (39.7%) and 123 patients in the control group (41.3%) had died (relative risk with IABP, 0.96; 95% confidence interval, 0.79 to 1.17; P = 0.69). There were no significant differences in secondary end points or in process-of-care measures, including the time to hemodynamic stabilization, the length of stay in the intensive care unit, serum lactate levels, the dose and duration of catecholamine therapy, and renal function. The IABP group and the control group did not differ significantly with respect to the rates of major bleeding (3.3% and 4.4%, respectively; P = 0.51), peripheral ischemic complications (4.3% and 3.4%, P = 0.53), sepsis (15.7% and 20.5%, P = 0.15), and stroke (0.7% and 1.7%, P = 0.28). CONCLUSIONS: The use of intraaortic balloon counterpulsation did not significantly reduce 30-day mortality in patients with cardiogenic shock complicating acute myocardial infarction for whom an early revascularization strategy was planned. (Funded by the German Research Foundation and others; IABP-SHOCK II ClinicalTrials.gov number, NCT00491036.) Copyright © 2012 Massachusetts Medical Society. Source

Thiele H.,University of Leipzig | Zeymer U.,Institute For Herzinfarktforschung | Neumann F.-J.,Albert Ludwigs University of Freiburg | Ferenc M.,Asklepios Clinic Langen Seligenstadt | And 16 more authors.
The Lancet

Background 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 benefi t only at extended follow-up. The present analysis therefore reports 6 and 12 month results. Methods 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 effi cacy 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. Findings 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 signifi cant diff erences 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 diff er signifi cantly between study groups. Interpretation In patients undergoing early revas cularisation for myocardial infarction complicated by cardiogenic shock, IABP did not reduce 12 month all-cause mortality. Funding German Research Foundation; German Heart Research Foundation; German Cardiac Society; Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte; University of Leipzig-Heart Centre; Maquet Cardiopulmonary; Teleflex Medical. Source

Prasad V.,Center for | Ambrosini V.,University of Bologna | Hommann M.,Zentralklinik Bad Berka | Hoersch D.,Oncology and Endocrinology | And 2 more authors.
European Journal of Nuclear Medicine and Molecular Imaging

Purpose: This bi-centric study aimed to determine the role of receptor PET/CT using 68Ga-DOTA-NOC in the detection of undiagnosed primary sites of neuroendocrine tumours (NETs) and to understand the molecular behaviour of the primarily undiagnosed tumours. Methods: Overall 59 patients (33 men and 26 women, age: 65 ± 9 years) with documented NET and unknown primary were enrolled. PET/CT was performed after injection of approximately 100 MBq (46-260 MBq) of 68Ga-DOTA-NOC. The maximum standardised uptake values (SUVmax) were calculated and compared with SUVmax in known pancreatic NET (pNET) and ileum/jejunum/duodenum (SI-NET). The results of PET/CT were also correlated with CT alone. Results: In 35 of 59 patients (59%), 68Ga-DOTA-NOC PET/CT localised the site of the primary: ileum/jejunum (14), pancreas (16), rectum/colon (2), lungs (2) and paraganglioma (1). CT alone (on retrospective analyses) confirmed the findings in 12 of 59 patients (20%). The mean SUVmax of identified previously unknown pNET and SI-NET were 18.6 ± 9.8 (range: 7.8-34.8) and 9.1 ± 6.0 (range: 4.2-27.8), respectively. SUVmax in patients with previously known pNET and SI-NET were 26.1 ± 14.5 (range: 8.7-42.4) and 11.3 ± 3.7 (range: 5.6-17.9). The SUVmax of the unknown pNET and SI-NET were significantly lower (p < 0.05) as compared to the ones with known primary tumour sites; 19% of the patients had high-grade and 81% low-grade NET. Based on 68Ga-DOTA-NOC receptor PET/CT, 6 of 59 patients were operated and the primary was removed (4 pancreatic, 1 ileal and 1 rectal tumour) resulting in a management change in approximately 10% of the patients. In the remaining 29 patients, because of the far advanced stage of the disease (due to distant metastases), the primary tumours were not operated. Additional histopathological sampling was available from one patient with bronchial carcinoid (through bronchoscopy). Conclusion: Our data indicate that 68Ga-DOTA-NOC PET/CT is highly superior to 111In-OctreoScan (39% detection rate for CUP according to the literature) and can play a major role in the management of patients with CUP-NET. © 2009 Springer-Verlag. Source

Thiele H.,University of Leipzig | Wohrle J.,University of Ulm | Hambrecht R.,Klinikum Links der Weser | Rittger H.,Klinikum Coburg | And 11 more authors.
The Lancet

Background: Intracoronary administration of an abciximab bolus during a primary percutaneous coronary intervention results in a high local drug concentration, improved perfusion, and reduction of infarct size compared with intravenous bolus application. However, the safety and efficacy of intracoronary versus standard intravenous bolus application in patients with ST-elevation myocardial infarction (STEMI) undergoing this intervention has not been tested in a large-scale clinical trial. Methods: The AIDA STEMI trial was a randomised, open-label, multicentre trial. Patients presenting with STEMI in the previous 12 h with no contraindications for abciximab were randomly assigned in a 1:1 ratio by a central web-based randomisation system to intracoronary versus intravenous abciximab bolus (0·25 mg/kg bodyweight) during percutaneous coronary intervention with a subsequent 12 h intravenous infusion 0·125 μg/kg per min (maximum 10 μg/min). The primary endpoint was a composite of all-cause mortality, recurrent infarction, or new congestive heart failure within 90 days of randomisation. Secondary endpoints were the time to occurrence of the primary endpoint, each individual component of that endpoint, early ST-segment resolution, thrombolysis in myocardial infarction (TIMI) flow grade, and enzymatic infarct size. A masked central committee adjudicated the primary outcome and its components. Treatment allocation was not concealed from patients and investigators. This trial is registered with ClinicalTrials.gov, NCT00712101. Findings: Between July, 2008, and April, 2011, 2065 patients were randomly assigned intracoronary abciximab (n=1032) or intravenous abciximab (n=1033). Intracoronary, as compared with intravenous abciximab, resulted in a similar rate of the primary composite clinical endpoint at 90 days in 1876 analysable patients (7·0 vs 7·6; odds ratio [OR] 0·91; 95 CI 0·64-1·28; p=0·58). The incidence of death (4·5 vs 3·6; 1·24; 0·78-1·97; p=0·36) and reinfarction (1·8 vs 1·8; 1·0; 0·51-1·96; p=0·99) did not differ between the treatment groups, whereas less patients in the intracoronary group had new congestive heart failure (2·4 vs 4·1; 0·57; 0·33-0·97; p=0·04). None of the secondary endpoints or safety measures differed significantly between groups. Interpretation: In patients with STEMI undergoing primary percutaneous coronary intervention, intracoronary as compared to intravenous abciximab did not result in a difference in the combined endpoint of death, reinfarction, or congestive heart failure. Since intracoronary abciximab bolus administration is safe and might be related to reduced rates of congestive heart failure the intracoronary route might be preferred if abciximab is indicated. Funding: Lilly, Germany. University of Leipzig - Heart Centre. University of Leipzig, Clinical Trial Centre Leipzig, supported by the Federal Ministry of Education and Research (BMBF). © 2012 Elsevier Ltd. Source

Shousha M.,Zentralklinik Bad Berka | Shousha M.,Alexandria University | Heyde C.,University of Leipzig | Boehm H.,Zentralklinik Bad Berka
European Spine Journal

Purpose: The incidence of spondylodiscitis is increasing. This study evaluates the behavior of cervical spondylodiscitis over a period of two decades in a single institution and compares the findings with the literature.Methods: Between 1994 and 1999, 20 consecutive patients (group A) suffering from cervical spondylodiscitis underwent surgical treatment in our institution. These were compared to another group consisting of 30 patients (group B) undergoing surgery for the same disease between 2004 and 2009 again in our institution. All patients in both series underwent surgical debridement and reconstruction followed by antibiotic therapy for 8–12 weeks.Results: The mean age at presentation increased significantly from 59.7 to 64.5 years. Male predominance was noticed in both groups. Accompanying neurological deficit was almost the same (40–45 %), while septicaemia increased from 15 to 40 %. Radiologically, epidural abscess formation increased from 60 to 80 %. The disease was mostly monosegmental in group A (85 %); while in group B, the disease became significantly more aggressive affecting two and three segments in 43.3 % of the cases. There was an increased tendency toward anterior alone surgery in group B (56.7 %) in comparison to group A (35 %). Mean period of follow-up was 2.8 years. Healing of the inflammation was the rule. Mortality rate increased from 5 to 10 %.Conclusions: Cervical spondylodiscitis has increased and became more aggressive. While radical surgical debridement, stable reconstruction together with antibiotic therapy remained a reliable approach to achieve complete healing of the inflammation, anterior alone surgery became more applicable. © 2014, Springer-Verlag Berlin Heidelberg. Source

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