Kreuzlingen, Switzerland
Kreuzlingen, Switzerland

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Kubo T.,Cardiovascular Research Foundation | Maehara A.,Cardiovascular Research Foundation | Mintz G.S.,Cardiovascular Research Foundation | Doi H.,Cardiovascular Research Foundation | And 13 more authors.
Journal of the American College of Cardiology | Year: 2010

Objectives: We used virtual histology intravascular ultrasound (VH-IVUS) to investigate the natural history of coronary artery lesion morphology. Background: Plaque stability is related to its histological composition. Methods: We performed serial (baseline and 12-month follow-up) VH-IVUS studies and examined 216 nonculprit lesions (plaque burden ≥40%) in 99 patients. Lesions were classified into pathological intimal thickening (PIT), VH-IVUS-derived thin-capped fibroatheroma (VH-TCFA), thick-capped fibroatheroma (ThCFA), fibrotic plaque, and fibrocalcific plaque. Results: At baseline, 20 lesions were VH-TCFAs; during follow-up, 15 (75%) VH-TCFAs "healed," 13 became ThCFAs, 2 became fibrotic plaque, and 5 (25%) VH-TCFAs remained unchanged. Compared with VH-TCFAs that healed, VH-TCFAs that remained VH-TCFAs located more proximally (values are median [interquartile range]) (16 mm [15 to 18 mm] vs. 31 mm [22 to 47 mm], p = 0.013) and had larger lumen (9.1 mm2 [8.2 to 10.7 mm2] vs. 6.9 mm2 [6.0 to 8.2 mm2], p = 0.021), vessel (18.7 mm2 [17.3 to 28.6 mm2] vs. 15.5 mm2 [13.3 to 16.6 mm2]; p = 0.010), and plaque (9.7 mm2 [9.6 to 15.7 mm2] vs. 8.4 mm2 [7 to 9.7 mm2], p = 0.027) areas; however, baseline VH-IVUS plaque composition did not differ between VH-TCFAs that healed and VH-TCFAs that remained VH-TCFAs. Conversely, 12 new VH-TCFAs developed; 6 late-developing VH-TCFAs were PITs, and 6 were ThCFAs at baseline. In addition, plaque area at minimum lumen sites increased significantly in PITs (7.8 mm2 [6.2 to 10.0 mm2] to 9.0 mm2 [6.5 to 12.0 mm2], p < 0.001), VH-TCFAs (8.6 mm2 [7.3 to 9.9 mm2] to 9.5 mm2 [7.8 to 10.8 mm2], p = 0.024), and ThCFAs (8.6 mm2 [6.8 to 10.2 mm2] to 8.8 mm2 [7.1 to 11.4 mm2], p < 0.001) with a corresponding decrease lumen areas, but not in fibrous or fibrocalcific plaque. Conclusions: Most VH-TCFAs healed during 12-month follow-up, whereas new VH-TCFAs also developed. PITs, VH-TCFAs, and ThCFAs showed significant plaque progression compared with fibrous and fibrocalcific plaque. © 2010 American College of Cardiology Foundation.


Raber L.,University of Bern | Kelbaek H.,Rigshospitalet | Baumbach A.,Bristol Heart Institute | Tuller D.,Triemlispital | And 13 more authors.
EuroIntervention | Year: 2012

Aims: Compared with bare metal stents (BMS), early generation drug-eluting stents (DES) reduce the risk of revascularisation in patients with ST-elevation myocardial infarction (STEMI) at the expense of an increased risk of very late stent thrombosis (ST). Durable polymer coatings for controlled drug release have been identified as a potential trigger for these late adverse events and this has led to the development of newer generation DES with durable and biodegradable polymer surface coatings with improved biocompatibility. In a recent all-comers trial, biolimus-eluting stents with a biodegradable polymer surface coating were found to reduce the risk of very late ST by 80% compared with sirolimus-eluting stents with durable polymer, which also translated into a lower risk of cardiac death and myocardial infarction (MI) beyond one year. Methods and results: The multicentre COMFORTABLE AMI trial (NCT00962416) randomly assigned 1,161 patients to treatment with biolimus-eluting stents with biodegrable polymer and bare metal stents of otherwise identical design at 11 international sites. The primary endpoint is a composite of cardiac death, target-vessel MI and target lesion revascularisation at one year. Assuming a relative risk reduction of 40% in event rates of the primary endpoint in favour of biolimus-eluting stents with biodegradable polymer, 1,064 patients will provide 80% power to demonstrate superiority. Clinical follow-up will be continued through five years. Conclusions: The COMFORTABLE AMI trial will determine whether biolimus-eluting stents with biodegradable polymer are superior to bare metal stents of otherwise identical design. This is the first randomised controlled trial (RCT) investigating DES with a biodegradable polymer surface coating for drug release in the treatment of patients with STEMI. © Europa Edition 2012. All rights reserved.


Sievers H.-H.,University of Lübeck | Stierle U.,University of Lübeck | Charitos E.I.,University of Lübeck | Hanke T.,University of Lübeck | And 22 more authors.
Circulation | Year: 2010

Background-: The purpose of the study is to report major cardiac and cerebrovascular events after the Ross procedure in the large adult and pediatric population of the German-Dutch Ross registry. These data could provide an additional basis for discussions among physicians and a source of information for patients. Methods and results-: One thousand six hundred twenty patients (1420 adults; 1211 male; mean age, 39.2±16.2 years) underwent a Ross procedure between 1988 and 2008. Follow-up was performed on an annual basis (median, 6.2 years; 10 747 patient-years). Early and late mortality were 1.2% (n=19) and 3.6% (n=58; 0.54%/patient-year), respectively. Ninety-three patients underwent 99 reinterventions on the autograft (0.92%/patient-year); 78 reinterventions in 63 patients on the pulmonary conduit were performed (0.73%/patient-year). Freedom from autograft or pulmonary conduit reoperation was 98.2%, 95.1%, and 89% at 1, 5, and 10 years, respectively. Preoperative aortic regurgitation and the root replacement technique without surgical autograft reinforcement were associated with a greater hazard for autograft reoperation. Major internal or external bleeding occurred in 17 (0.15%/patient-year), and a total of 38 patients had composite end point of thrombosis, embolism, or bleeding (0.35%/patient-year). Late endocarditis with medical (n=16) or surgical treatment (n=29) was observed in 38 patients (0.38%/patient-year). Freedom from any valve-related event was 94.9% at 1 year, 90.7% at 5 years, and 82.5% at 10 years. Conclusions-: Although longer follow-up of patients who undergo Ross operation is needed, the present series confirms that the autograft procedure is a valid option to treat aortic valve disease in selected patients. The nonreinforced full root technique and preoperative aortic regurgitation are predictors for autograft failure and warrant further consideration. © 2010 American Heart Association, Inc.


Raber L.,University of Bern | Kelbaek H.,Rigshospitalet | Baumbach A.,Bristol Heart Institute | Heg D.,University of Bern | And 18 more authors.
JAMA - Journal of the American Medical Association | Year: 2012

Context: The efficacy and safety of drug-eluting stents compared with bare-metal stents remains controversial in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Objective: To compare stents eluting biolimus from a biodegradable polymer with bare-metal stents in primary PCI. Design, Setting, and Patients: A prospective, randomized, single-blinded, controlled trial of 1161 patients presenting with STEMI at 11 sites in Europe and Israel between September 19, 2009, and January 25, 2011. Clinical follow-up was performed at 1 and 12 months. Intervention: Patients were randomized 1:1 to receive the biolimus-eluting stent (n=575) or the bare-metal stent (n=582). Main Outcome Measures: Primary end point was the rate of major adverse cardiac events, a composite of cardiac death, target vessel-related reinfarction, and ischemiadriven target-lesion revascularization at 1 year. Results: Major adverse cardiac events at 1 year occurred in 24 patients (4.3%) receiving biolimus-eluting stents with biodegradable polymer and 49 patients (8.7%) receiving bare-metal stents (hazard ratio [HR], 0.49; 95% CI, 0.30-0.80; P=.004). The difference was driven by a lower risk of target vessel-related reinfarction (3 [0.5%] vs 15 [2.7%]; HR, 0.20; 95% CI, 0.06-0.69; P=.01) and ischemia-driven target-lesion revascularization (9 [1.6%] vs 32 [5.7%]; HR, 0.28; 95% CI, 0.13-0.59; P<.001) in patients receiving biolimus-eluting stents compared with those receiving bare-metal stents. Rates of cardiac death were not significantly different (16 [2.9%] vs 20 [3.5%], P=.53). Definite stent thrombosis occurred in 5 patients (0.9%) treated with biolimus-eluting stents and 12 patients (2.1%; HR, 0.42; 95% CI, 0.15-1.19; P=.10) treated with bare-metal stents. Conclusion: Compared with a bare-metal stent, the use of biolimus-eluting stents with a biodegradable polymer resulted in a lower rate of the composite of major adverse cardiac events at 1 year among patients with STEMI undergoing primary PCI. Trial Registration: clinicaltrials.gov Identifier: NCT00962416. ©2012 American Medical Association. All rights reserved.


Magro M.,University of Bern | Magro M.,Erasmus University Rotterdam | Raber L.,University of Bern | Heg D.,University of Bern | And 15 more authors.
International Journal of Cardiology | Year: 2014

Background To investigate the performance of the MI Sxscore in a multicentre randomised trial of patients undergoing primary percutaneous coronary intervention (PPCI). Methods and results The MI Sxscore was prospectively determined among 1132 STEMI patients enrolled into the COMFORTABLE AMI trial, which randomised patients to treatment with bare-metal (BMS) or biolimus-eluting (BES) stents. Patient- (death, myocardial infarction, any revascularisation) and device-oriented (cardiac death, target-vessel MI, target lesion revascularisation) major adverse cardiac events (MACEs) were compared across MI Sxscore tertiles and according to stent type. The median MI SXscore was 14 (IQR: 9-21). Patients were divided into tertiles of Sxscorelow (≤ 10), Sxscoreintermediate (11-18) and Sxscore intermediate (≥ 19). At 1 year, patient-oriented MACE occurred in 15% of the Sxscoreintermediate, 9% of the Sxscore intermediate and 5% of the Sxscoreintermediate tertiles (p < 0.001), whereas device-oriented MACE occurred in 8% of the Sxscore intermediate, 6% of the Sxscoreintermediate and 4% of the Sxscoreintermediate tertiles (p = 0.03). Addition of the MI Sxscore to the TIMI risk score improved prediction of patient- (c-statistic value increase from 0.63 to 0.69) and device-oriented MACEs (c-statistic value increase from 0.65 to 0.70). Differences in the risk for device-oriented MACE between BMS and BES were evident among Sxscoreintermediate (13% vs. 4% HR 0.33 (0.15-0.74), p = 0.007 rather than those in Sxscore intermediate: 4% vs. 3% HR 0.68 (0.24-1.97), p = 0.48) tertiles. Conclusions The MI Sxscore allows risk stratification of patient- and device-oriented MACEs among patients undergoing PPCI. The addition of the MI Sxscore to the TIMI risk score is of incremental prognostic value among patients undergoing PPCI for treatment of STEMI. © 2014 Elsevier Ireland Ltd.


Fajadet J.,Clinique Pasteur | Wijns W.,Cardiovascular Center | Laarman G.-J.,Onze Lieve Vrouwe Gasthuis | Kuck K.-H.,Krankenhaus Sankt Georg | And 8 more authors.
EuroIntervention | Year: 2010

Aims: We report here the final 5-year follow-up results from the ENDEAVOR II trial, which was the first randomised trial evaluating the Endeavor™ zotarolimus-eluting stent (ZES) compared with a bare metal stent (BMS) in patients with single, de novo coronary artery lesions. Methods and results: Eligible patients were randomised 1:1 to receive ZES or BMS and were followed by telephone or clinic visit up to five years. We evaluated TVF and its components (target vessel revascularisation [TVR], Q-wave or non Q-wave myocardial infarction, or cardiac death attributed to the target vessel) at five years. Additionally, we report rates of MACE, TLR, and stent thrombosis (protocol- and ARC-defined) through five years. ENDEAVOR II enrolled 1,197 patients (598 ZES, 599 BMS). At five years of follow-up, the rates of TVF (15.4% vs 24.4%), TVR (10.7% vs 20.1%), MACE (15.4% vs 24.6%), and TLR (7.5% vs 16.3%) remained significantly lower in ZES patients compared with BMS patients. ARC definite and probable very late (>1 year) stent thrombosis remained low (0.2% ZES and 0.3% BMS) through five years. Conclusions: After five years of follow-up, ZES demonstrated significantly improved clinical outcomes with sustained safety compared with BMS in patients with obstructive coronary artery disease. © Europa Edition 2010. All rights reserved.


Born F.,Herzzentrum Bodensee | Born F.,Furtwangen University of Applied Sciences | Dreizler T.,Herzzentrum Bodensee | Lipps C.,Herzzentrum Bodensee | And 5 more authors.
Kardiotechnik | Year: 2010

During the last decade, patients suffering from coronary heart disease have been increasingly treated using minimized perfusion systems. Since its introduction on the market, the share of MECC-system usage has increased to approximately 5% and is now stabilised. The extracorporeal circulation (ECC) is still the key technology in open-heart surgery applications. This is particularly valid for coronary surgery. Perfusion systems and strategies have been repetitively modified over the past few years and adapted to the available technical possibilities. The innovations in the field of oxygenator and filter development, as well as surface coating, were important steps for optimising the ECC. ECC systems must be further improved to increase their safety in application thus protecting the patient from undesirable effects of the conventional cardiopulmonary bypass [1,2]. This is the goal in the development of optimised ECC systems. Currently, a variety of different systems offering a clear reduction of the priming volume and the foreign surface contact are available on the market. In our hospital, a continuous advancement of minimized systems has been taking place since 1999. Operations are performed applying different minimized perfusion systems in patient-specific configurations.


Mercado N.,University of Missouri - Kansas City | Moe T.G.,University of Missouri - Kansas City | Pieper M.,Herzzentrum Bodensee | House J.A.,University of Missouri - Kansas City | And 6 more authors.
EuroIntervention | Year: 2011

Aims: To characterise plaque phenotypes in the left main stem (LMS) and the proximal left anterior descending (LAD) coronary artery using virtual histology assisted intravascular ultrasound (VH-IVUS). Methods and results: Patients with IVUS pullbacks including no less than the proximal 30 mm of the LAD and through the ostium of the left main were identified from a global IVUS registry. Plaque composition and phenotype frequency in the LMS and five consecutive non-overlapping 6 mm segments in the LAD were studied, resulting in six analysed segments per patient. There were 74 patients (72% male, mean age 65 years). The median LMS length was 5.4 mm (IQR 2.8-8.7 mm). The percent of fibrofatty plaque was greater in the LMS compared to the proximal LAD segments (27.9% [20.0-39.2] vs. 17.3% [12.2-23.1], p<0.001). Dense calcium and necrotic core content was less prevalent in the LMS compared to the LAD segments (2.5% [0.9-4.7] vs. 7.9% [4.1-12.3], p<0.001; and 8.0% [3.7-11.8] vs. 14% [9.2-17.9], p<0.001). The frequency of thin cap fibroatheroma (TCFA) was higher in the LAD compared with LMS (0% vs. 16.9% [4.9- 34.5], p < 0.001,). Within the LAD, TCFA was most frequently observed in the second 6 mm segment, 12 mm from the ostium. Conclusions: TCFA was present more frequently in the proximal LAD than LMS, supporting the notion that plaque rupture occurs in non-uniform locations throughout the coronary tree and preferentially spares the LMS. © Europa Edition 2011. All rights reserved.

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