Jörg Hausleiter

Technische Universität München, München, Bavaria, Germany

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Publications (162)1226.69 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: Purpose To determine the clinical outcomes of women and men with nonobstructive coronary artery disease (CAD) with coronary computed tomographic (CT) angiography data in patients who were similar in terms of CAD risk factors, angina typicality, and CAD extent and distribution. Materials and Methods Institutional review board approval was obtained for all participating sites, with either informed consent or waiver of informed consent. In a prospective international multicenter cohort study of 27 125 patients undergoing coronary CT angiography at 12 centers, 18 158 patients with no CAD or nonobstructive (<50% stenosis) CAD were examined. Men and women were propensity matched for age, CAD risk factors, angina typicality, and CAD extent and distribution, which resulted in a final cohort of 11 462 subjects. Nonobstructive CAD presence and extent were related to incident major adverse cardiovascular events (MACE), which were inclusive of death and myocardial infarction and were estimated by using multivariable Cox proportional hazards models. Results At a mean follow-up ± standard deviation of 2.3 years ± 1.1, MACE occurred in 164 patients (0.6% annual event rate). After matching, women and men experienced identical annualized rates of myocardial infarction (0.2% vs 0.2%, P = .72), death (0.5% vs 0.5%, P = .98), and MACE (0.6% vs 0.6%, P = .94). In multivariable analysis, nonobstructive CAD was associated with similarly increased MACE for both women (hazard ratio: 1.96 [95% confidence interval {CI}: 1.17, 3.28], P = .01) and men (hazard ratio: 1.77 [95% CI: 1.07, 2.93], P = .03). Conclusion When matched for age, CAD risk factors, angina typicality, and nonobstructive CAD extent, women and men experience comparable rates of incident mortality and myocardial infarction. © RSNA, 2014 Online supplemental material is available for this article.
    Radiology 07/2014; · 6.34 Impact Factor
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    ABSTRACT: Prior studies evaluating the prognostic utility of cardiac CT angiography (CCTA) have been largely constrained to an all-cause mortality endpoint, with other cardiac endpoints generally not reported. To this end, we sought to determine the relationship of extent and severity of coronary artery disease (CAD) by CCTA to risk of incident major adverse cardiac events (MACEs) (defined as death, myocardial infarction, and late revascularization). We identified subjects without prior known CAD who underwent CCTA and were followed for MACE. CAD by CCTA was defined as none (0% luminal stenosis), mild (1-49% luminal stenosis), moderate (50-69% luminal stenosis), or severe (≥70% luminal stenosis), and ≥50% luminal stenosis was considered as obstructive. CAD severity was judged on per-patient, per-vessel, and per-segment basis. Time to MACE was estimated using univariable and multivariable Cox proportional hazards models. Among 15 187 patients (57 ± 12 years, 55% male), 595 MACE events (3.9%) occurred at a 2.4 ± 1.2 year follow-up. In multivariable analyses, an increased risk of MACE was observed for both non-obstructive [hazard ratio (HR) 2.43, P < 0.001] and obstructive CAD (HR: 11.21, P < 0.001) when compared with patients with normal CCTA. Risk-adjusted MACE increased in a dose-response relationship based on the number of vessels with obstructive CAD ≥50%, with increasing hazards observed for non-obstructive (HR: 2.54, P < 0.001), obstructive one-vessel (HR: 9.15, P < 0.001), two-vessel (HR: 15.00, P < 0.001), or three-vessel or left main (HR: 24.53, P < 0.001) CAD. Among patients stratified by age <65 vs. ≥65 years, older individuals experienced higher risk-adjusted hazards for MACE for non-obstructive, one-, and two-vessel, with similar event rates for three-vessel or left main (P < 0.001 for all) compared with normal individuals age <65. Finally, there was a dose relationship of CAD findings by CCTA and MACE event rates with each advancing decade of life. Among individuals without known CAD, non-obstructive, and obstructive CAD are associated with higher MACE rates, with different risk profiles based on age.
    European heart journal cardiovascular Imaging. 05/2014; 15(5):586-94.
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    ABSTRACT: In clopidogrel treated patients undergoing percutaneous coronary intervention (PCI), high platelet reactivity (HPR) is associated with a higher risk for thrombotic events including stent thrombosis (ST). A personalised therapy with selective intensification of treatment may improve HPR patients´ outcome in this setting although recent randomised trials are against this hypothesis. The aim of the ISAR-HPR registry was to assess whether clopidogrel-treated HPR patients benefit from selective intensification of P2Y12 receptor inhibition. For the registry, outcomes were compared between two cohorts. We identified 428 clopidogrel treated HPR patients (AU x min ≥468 on the Multiplate analyser) between 2007-2008 (historical control cohort) without a change of treatment based on platelet function (PF) testing results. Between 2009-2011, we identified 571 HPR patients (guided therapy cohort) and used this information for guidance and selective intensification of P2Y12 receptor directed treatment (reloading with clopidogrel, switch to prasugrel, re-testing) in a setting of routine PF testing. The primary outcome was the composite of death from any cause or ST after 30 days. Major bleeding according to TIMI criteria was also monitored. The incidence of the primary outcome was significantly lower in the guided vs the control cohort (7 [1.2%] vs 16 [3.7%] events; HR 0.32, 95% CI 0.13-0.79; p=0.009). The incidence of major bleeding was numerically but not statistically higher in the guided vs the control cohort (1.9 vs 0.7%; p=0.10). In conclusion, present findings are in support for a PF testing guided antiplatelet therapy with selective intensification of P2Y12 receptor inhibition. The issue of personalised antiplatelet treatment warrants further investigation in randomized and well-controlled clinical trials.
    Thrombosis and Haemostasis 04/2014; 112(2). · 6.09 Impact Factor
  • International Journal of Clinical Practice 04/2014; 68(4). · 2.43 Impact Factor
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    ABSTRACT: Coronary artery calcium (CAC) is a well-established predictor of clinical outcomes for population screening. Limited evidence is available as to its predictive value in symptomatic patients without obstructive coronary artery disease (CAD). The aim of the current study was to assess the prognostic value of CAC scores among symptomatic patients with nonobstructive CAD. From the COronary Computed Tomographic Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter (CONFIRM) registry, 7,200 symptomatic patients with nonobstructive CAD (<50% coronary stenosis) on coronary-computed tomographic angiography were prospectively enrolled and followed for a median of 2.1 years. Patients were categorized as without (0% stenosis) or with (>0% but <50% coronary stenosis) a luminal stenosis. CAC scores were calculated using the Agatston method. Univariable and multivariable Cox proportional hazard models were employed to estimate all-cause mortality and/or myocardial infarction (MI). Four-year death and death or MI rates were 1.9% and 3.3%. Of the 4,380 patients with no luminal stenosis, 86% had CAC scores of <10 while those with a luminal stenosis had more prevalent and extensive CAC with 31.9% having a CAC score of ≥100. Among patients with no luminal stenosis, CAC was not predictive of all-cause mortality (P = .44). However, among patients with a luminal stenosis, 4-year mortality rates ranged from 0.8% to 9.8% for CAC scores of 0 to ≥400 (P < .0001). The mortality hazard was 6.0 (P = .004) and 13.3 (P < .0001) for patients with a CAC score of 100-399 and ≥400. In patients with a luminal stenosis, CAC remained independently predictive in all-cause mortality (P < .0001) and death or MI (P < .0001) in multivariable models containing CAD risk factors and presenting symptoms. CAC allows for the identification of those at an increased hazard for death or MI in symptomatic patients with nonobstructive disease. From the CONFIRM registry, the extent of CAC was an independent estimator of long-term prognosis among symptomatic patients with luminal stenosis and may further define risk and guide preventive strategies in patients with nonobstructive CAD.
    Journal of Nuclear Cardiology 03/2014; · 2.85 Impact Factor
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    ABSTRACT: BACKGROUND: Short-term risk scores, such as the Framingham risk score (FRS), frequently classify younger patients as low risk despite the presence of uncontrolled cardiovascular risk factors. Among patients with low FRS, estimation of lifetime risk is associated with significant differences in coronary arterial calcium scores (CACS); however, the relationship of lifetime risk to coronary atherosclerosis on coronary CT angiography (CCTA) and prognosis has not been studied. METHODS AND RESULTS: We evaluated asymptomatic 20-60-year-old patients without diabetes or known coronary artery disease (CAD) within an international CT registry who underwent ≥64-slice CCTA. Patients with low FRS (<10%) were stratified as low (<39%) or high (≥39%) lifetime CAD risk, and compared for the presence and severity of CAD and prognosis for death, myocardial infarction, and late coronary revascularization (>90 days post CCTA). 1,863 patients of mean age of 47 years were included, with 48% of the low FRS patients at high lifetime risk. Median follow-up was 2.0 years. Comparing low-to-high lifetime risk, respectively, the prevalence of any CAD was 32% vs 41% (P < .001) and ≥50% stenosis was 7.4% vs 9.6% (P = .09). For those with CAD, subjects at low vs high lifetime risk had lower CACS (median 12 [IQR 0-94] vs 38 [IQR 0.05-144], P = .02) and less purely calcified plaque, 35% vs 45% (P < .001). Prognosis did not differ due to low number of events. CONCLUSION: Assessment of lifetime risk among patients at low FRS identified those with the increase in CAD prevalence and severity and a higher proportion of calcified plaque.
    Journal of Nuclear Cardiology 01/2014; 21(1):29-37. · 2.85 Impact Factor
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    ABSTRACT: Objective To identify key components of a radiation accountability framework fostering patient-centered imaging and shared decision-making in cardiac imaging. Background An NIH-NHLBI/NCI-sponsored symposium was held in November 2012 to address these issues. Methods Symposium participants, working in three tracks, identified key components of a framework to target critical radiation safety issues for the patient, the laboratory, and the larger population of patients with known or suspected cardiovascular disease. Results Use of ionizing radiation during an imaging procedure should be disclosed to all patients by the ordering provider at the time of ordering, and reinforced by the performing provider team. An imaging protocol with effective dose ≤3mSv is considered very low risk, not warranting extensive discussion or written consent. However, a protocol effective dose <20mSv was proposed as a level requiring particular attention in terms of shared decision-making and either formal discussion or written informed consent.Laboratory reporting of radiation dosimetry is a critical component of creating a quality laboratory fostering a patient-centered environment with transparent procedural methodology. Efforts should be directed to avoiding testing involving radiation, in patients with inappropriate indications. Standardized reporting and diagnostic reference levels for computed tomography and nuclear cardiology are important for the goal of public reporting of laboratory radiation dose levels in conjunction with diagnostic performance. Conclusions The development of cardiac imaging technologies revolutionized cardiology practice by allowing routine, noninvasive assessment of myocardial perfusion and anatomy. It is now incumbent upon the imaging community to create an accountability framework to safely drive appropriate imaging utilization.
    Journal of the American College of Cardiology 01/2014; · 14.09 Impact Factor
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    ABSTRACT: Background The diagnostic performance of Multi-Detector CT to detect coronary artery stenosis has been evaluated in numerous single center studies, with only very limited data from large cohorts with low to intermediate likelihood of coronary disease and in multi-center trials. The MEDIC trial determines the accuracy of dual source CT to identify individuals with at least one coronary artery stenosis among patients with low-to-intermediate pre-test likelihood of disease. Methods The MEDIC trial was designed as a prospective, multi-center, international trial to evaluate the diagnostic performance of dual source CT for the detection of coronary artery stenosis compared to invasive coronary angiography. The study includes eight sites in Germany, India, Mexico, the United States of America and Denmark. The study population comprises patients referred for a diagnostic coronary angiogram due to suspected coronary artery disease with an intermediate pre-test likelihood as determined by gender, age, and symptoms. All evaluations are performed by blinded core laboratory readers. Results The primary outcome of the MEDIC trial is the accuracy of DSCT to identify the presence of coronary artery stenoses with a luminal diameter narrowing of 50% or more on a per-vessel basis. Secondary outcome parameters include per-patient and per-segment diagnostic accuracy for 50% stenoses as well as accuracy to identify stenoses of 70% or more. Furthermore, secondary outcome parameters include the influence of heart rate, calcium score, body weight, body mass index, image quality and diagnostic confidence on the accuracy to detect coronary artery stenoses > 50% on a per-vessel basis Conclusion The results of the MEDIC trial will assess the clinical utility of coronary CT angiography in the evaluation of patients with intermediate pretest likelihood of coronary artery disease.
    Journal of Cardiovascular Computed Tomography. 01/2014;
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    ABSTRACT: Objectives. To prospectively assess the outcome of percutaneous edge-to-edge repair in patients with degenerative vs. functional mitral regurgitation (MR). Background. The optimal patient population eligible for percutaneous edge-to-edge repair has yet to be defined. Methods. We analyzed 119 patients treated by percutaneous edge-to-edge repair for symptomatic MR, 72 patients with degenerative and 47 patients with functional MR. The primary endpoints were defined as procedural success (MR grade reduction ≥ 1 grade) as well as a composite endpoint defined as freedom from MR 3+ or 4+, mitral valve reintervention and death 12 months after clip implantation. In patients with successful clip placement we further analyzed MR grade, NYHA functional class, distance in the 6 minute walking test and left ventricular volumes 12 months after clip implantation. Results. The primary success rate of all intended clipping procedures was 83.3% for degenerative and 89.4% for functional MR (P = 0.42). Regarding the composite endpoint we observed an event free survival of 59.7% in patients treated for degenerative MR and 63.8% in patients treated for functional MR (P = 0.73). We observed a highly significant reduction in MR grade as well as improvement in NYHA functional status in both groups 12 months after clip implantation. However, there was a more pronounced MR grade reduction in patients treated for degenerative MR compared to patients treated for functional MR. Conclusions. Percutaneous edge-to-edge repair of the mitral valve is feasible and comparably effective in patients with degenerative and functional MR. © 2013 Wiley Periodicals, Inc.
    Catheterization and Cardiovascular Interventions 12/2013; · 2.51 Impact Factor
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    ABSTRACT: OBJECTIVES: This study sought to compare the safety and efficacy of the zotarolimus-eluting stent (ZES) and the everolimus-eluting stent (EES) for treatment of unprotected left main coronary artery (uLMCA) disease. BACKGROUND: The second-generation ZES and EES have reduced the risk of restenosis in large patient cohorts. However, their comparative performance in uLMCA lesions is not known. METHODS: In this study, patients with symptomatic coronary artery disease undergoing percutaneous coronary intervention for uLMCA lesions were randomly assigned to receive either a ZES (n = 324) or an EES (n = 326). The primary endpoint was the combined incidence of death, myocardial infarction, and target lesion revascularization at 1 year. Secondary endpoints were definite or probable stent thrombosis at 1 year and angiographic restenosis based on analysis of the left main coronary artery area at follow-up angiography. RESULTS: At 1 year, the cumulative incidence of the primary endpoint was 17.5% in the ZES group and 14.3% in the EES group (relative risk: 1.26; 95% confidence interval [CI]: 0.85 to 1.85; p = 0.25). Three patients in the ZES group (0.9%) and 2 patients in the EES group (0.6%) experienced definite or probable stent thrombosis (p > 0.99). All-cause mortality at 1 year was equal in the 2 groups (5.6%; relative risk: 1.00; 95% CI: 0.52 to 1.93; p = 0.98). Angiographic restenosis occurred in 21.5% of patients in the ZES group and 16.8% in the EES group (relative risk: 1.28; 95% CI: 0.86 to 1.92; p = 0.24). CONCLUSIONS: Within the statistical limitations of the present study, treatment of uLMCA lesions with a ZES or an EES provided comparable clinical and angiographic outcomes at 1-year follow-up.
    Journal of the American College of Cardiology 12/2013; 62(22):2075-82. · 14.09 Impact Factor
  • Birgit Langhans, Joerg Hausleiter, Fabian Bamberg
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    ABSTRACT: Imaging is a highly attractive option for improved risk stratification, as it allows direct detection and quantification of subclinical and clinical disease burden. Among available imaging techniques, MRI may be particularly suited for comprehensive cardiovascular risk assessment given its non-ionizing nature and high soft-tissue contrast. In this editorial, the authors review the emerging evidence in different clinical scenarios, indicating the incremental role of MRI for determining risk for future cardiovascular events.
    Expert Review of Cardiovascular Therapy 12/2013;
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    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. · 39.06 Impact Factor
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    ABSTRACT: Infarct size is an important predictor of cardiac risk after acute myocardial infarction. The established modality for its assessment is Tc99m-Sestamibi Single-photon emission computed tomography (SPECT). In recent years, data are emerging demonstrating that scar size as assessed by late gadolinium enhancement in cardiovascular magnetic resonance imaging (CMR) as well as the presence of microvascular obstruction (MO) may also provide prognostic information, however, so far no direct comparisons of both modalities have been reported. We retrospectively analysed patients (n = 281) with acute ST-elevation myocardial infarction and primary angioplasty who underwent Tc99m-Sestamibi-SPECT and CMR on a 1.5 T scanner at a median of 4.3 (IQR: 3.7-5.1) and 4.9 (IQR: 4.1-5.9) days after the acute event, respectively. The primary endpoint of the study was a composite of all-cause mortality, recurrent myocardial infarction and congestive heart failure requiring hospitalization. During a median follow-up of 3.0 (IQR: 2.0-4.5) years, 24 events occurred. The best predictor was MO (P < 0.0001), followed by infarct size by CMR (P = 0.0043) and infarct size by SPECT (P = 0.012) (all P-values corrected for clinical risk). In a multivariate model including clinical and periprocedural parameters, MO remained the only significant predictor in addition to clinical risk. The extent of MO as determined by CMR has an excellent prognostic value in predicting cardiac events following acute myocardial infarction and may be used as an alternative to infarct size assessment by Tc99m-Sestamibi-SPECT.
    European heart journal cardiovascular Imaging. 11/2013;
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    ABSTRACT: Aims: To evaluate the characteristics and clinical outcome of patients with new formation of left ventricular (LV) thrombus after percutaneous edge-to-edge mitral valve repair. Methods and results: Between 2009 and 2012 we intended to treat 150 patients with severe mitral regurgitation (MR) with percutaneous edge-to-edge mitral valve repair in our centre. Post-procedural transthoracic echocardiographic examinations scheduled during the hospital stay revealed the new formation of LV thrombi in three out of 150 patients. All three patients suffered from end-stage systolic heart failure with a LV ejection fraction (LVEF) below 20% and were successfully treated in terms of MR reduction (reduction of at least two MR grades). No thrombus formation was observed in patients with a LVEF >20% treated in our centre (a total of 136 patients). The frequency of new LV thrombus formation in the cohort of patients with a LVEF ≤20% treated in our centre was 21% (three out of 14 patients). Conclusions: New formation of LV thrombus was detected in patients with severely depressed LVEF (≤20%) after successful reduction of MR following percutaneous edge-to-edge mitral valve repair. This phenomenon could be a play of chance, but percutaneous edge-to-edge mitral valve repair using the MitraClip® system is a new procedure. Special care is needed when performing new procedures, and the unexpected post-procedural finding of LV thrombus formation in approximately 20% in this cohort is worth reporting.
    EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 10/2013; · 3.17 Impact Factor
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    ABSTRACT: There is little consensus on optimal atrioventricular (AV) and ventricular-to-ventricular (VV) intervals in cardiac resynchronization therapy (CRT). The aim of this study was to examine a novel combination of Doppler echocardiography (DE) and three-dimensional echocardiography (3DE) for individualized AV- and VV-interval optimization compared to conventional electrocardiogram (ECG) optimization. In this double-blind, randomized controlled trial, 77 patients (male: 57, age: 68 ± 10 years) with severely reduced ejection fraction (EF), New York Heart Association (NYHA) class III or IV, and wide QRS complex (>120 ms) have been included. Patients were randomized to either AV- and VV-interval optimization using DE and 3DE (group 1, n = 39) or ECG (group 2, n = 38). 3DE was performed in all patients for the evaluation of left ventricular (LV) dimensions, EF and systolic dyssynchrony index (SDI), and NYHA class obtained before CRT and after 3 months. Primary endpoint of the study was clinical response to CRT, defined as a reduction of NYHA class by ≥1 score. Secondary endpoints were change of EF, LV volumes, and SDI. There were significantly more responders in group 1 (82%) than in group 2 (58%, P = 0.021). Similarly, group 1 showed a larger increase in EF (7.0 ± 6.0% vs 3.4 ± 5.6%, P = 0.015) and a more pronounced reduction of SDI (-4.5 ± 5.9% vs -1.5 ± 5.6%, P = 0.039) than group 2. Compared with conventional ECG optimization, this novel echocardiographic optimization protocol resulted in a significantly higher response rate, improved LV systolic function, and may be used to select the optimal AV and VV intervals in CRT.
    Pacing and Clinical Electrophysiology 10/2013; · 1.75 Impact Factor
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    ABSTRACT: Coronary computed tomography angiography (CCTA) has a high accuracy for detection of obstructive coronary artery disease (CAD). Several studies also showed a good predictive value for subsequent cardiac events. However, the follow-up period of these studies was limited to ∼2 years and long-term follow-up data on prognosis out to 5 years are very limited. This study is based on 1584 patients with suspected CAD undergoing CCTA between December 2003 and November 2006. Among other CCTA parameters, the total plaque score defined as number of abnormal segments (having either a non-obstructive plaque or a stenosis) and the most severe stenosis were recorded. The primary endpoint was a composite of death and non-fatal myocardial infarction. Revascularization procedures later than 90 days after the CT study were assessed as secondary endpoints.During a median follow-up of 5.6 years (IQR: 5.1-6.3 years) 61 patients suffered death or myocardial infarction and 52 underwent late revascularization. The severity of CAD and the total plaque score were the best predictors of death and non-fatal myocardial infarction, both significantly improving prediction over standard clinical risk scores (multivariate c-index 0.60 and 0.66, respectively, P = 0.002 and <0.0001, respectively). The annual event rate ranged from 0.24% for patients with no CAD to 1.1% for patients with obstructive CAD and 1.5% for patients with CAD and extensive plaque load (>5 segments). Both parameters also improved prediction of need for subsequent revascularization (c-index 0.72 and 0.63, respectively, P < 0.0001 and P = 0.0013, respectively). Data from CCTA predict both death and myocardial infarction as well as need for subsequent revascularizations out to 5 years. CCTA imaging may be a valuable tool in the assessment of long-term prognosis in patients with suspected CAD.
    European Heart Journal 09/2013; · 14.10 Impact Factor
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    ABSTRACT: The interventional treatment of mitral valve regurgitation by the MitraClip procedure has grown rapidly in Germany and Europe during the past years. The MitraClip procedure has the potential to treat high-risk patients with secondary mitral valve regurgitation and poor left ventricular function. Furthermore, patients with primary mitral valve regurgitation may be treated successfully by the MitraClip procedure in case of high surgical risk or in very old patients. At the same time it has been emphasised that the MitraClip interventional treatment is still at an early stage of clinical development. The largest clinical experience with the MitraClip procedure so far is probably present in some German cardiovascular centers, which here summarise their recommendations on the current indications and procedural steps of the MitraClip treatment. These recommendations of the AGIK and ALKK may present a basis for future development.
    Clinical Research in Cardiology 09/2013; · 3.67 Impact Factor
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    ABSTRACT: The prognostic value of coronary artery calcium (CAC) scoring is well established and has been suggested for use to exclude significant coronary artery disease (CAD) for symptomatic individuals with CAD. Contrast-enhanced coronary computed tomographic angiography (CCTA) is an alternative modality that enables direct visualization of coronary stenosis severity, extent, and distribution. Whether CCTA findings of CAD add an incremental prognostic value over CAC in symptomatic individuals has not been extensively studied. We prospectively identified symptomatic patients with suspected but without known CAD who underwent both CAC and CCTA. Symptoms were defined by the presence of chest pain or dyspnoea, and pre-test likelihood of obstructive CAD was assessed by the method of Diamond and Forrester (D-F). CAC was measured by the method of Agatston. CCTAs were graded for obstructive CAD (>70% stenosis); and CAD plaque burden, distribution, and location. Plaque burden was determined by a segment stenosis score (SSS), which reflects the number of coronary segments with plaque, weighted for stenosis severity. Plaque distribution was established by a segment-involvement score (SIS), which reflects the number of segments with plaque irrespective of stenosis severity. Finally, a modified Duke prognostic index-accounting for stenosis severity, plaque distribution, and plaque location-was calculated. Nested Cox proportional hazard models for a composite endpoint of all-cause mortality and non-fatal myocardial infarction (D/MI) were employed to assess the incremental prognostic value of CCTA over CAC. A total of 8627 symptomatic patients (50% men, age 56 ± 12 years) followed for 25 months (interquartile range 17-40 months) comprised the study cohort. By CAC, 4860 (56%) and 713 (8.3%) patients had no evident calcium or a score of >400, respectively. By CCTA, 4294 (49.8%) and 749 (8.7%) had normal coronary arteries or obstructive CAD, respectively. At follow-up, 150 patients experienced D/MI. CAC improved discrimination beyond D-F and clinical variables (area under the receiver-operator characteristic curve 0.781 vs. 0.788, P = 0.004). When added sequentially to D-F, clinical variables, and CAC, all CCTA measures of CAD improved discrimination of patients at risk for D/MI: obstructive CAD (0.82, P < 0.001), SSS (0.81, P < 0.001), SIS (0.81, P = 0.003), and Duke CAD prognostic index (0.82, P < 0.0001). In symptomatic patients with suspected CAD, CCTA adds incremental discriminatory power over CAC for discrimination of individuals at risk of death or MI.
    European heart journal cardiovascular Imaging. 08/2013;
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    ABSTRACT: Percutaneous treatment with the MitraClip device represents an alternative option for selected patients with degenerative mitral regurgitation (DMR) considered ineligible for surgery due to contraindications or high surgical risk by an inter-disciplinary heart team. We describe 12-month outcomes following treatment with the MitraClip device in DMR patients. The MitraClip Therapy Economic and Clinical Outcomes Study Europe (ACCESS-EU) Study has completed the enrolment of 567 patients as of April 2011, 117 of whom were DMR. Baseline demographics, procedural and acute safety results at 30 days and survival at 12 months were evaluated in the DMR subset. Effectiveness results, defined by a reduction in MR, and improvement in clinical outcomes based on changes in New York Heart Association (NYHA) functional Class, 6-min walk test (6MWT) and quality-of-life data were also assessed. Furthermore, DMR patients were stratified into high- and low-risk subgroups (logistic European System of Cardiac Operative Risk Evaluation I (logEuroSCORE I ≥20% or <20%, respectively) and differentially evaluated. One hundred and seventeen DMR patients underwent the MitraClip procedure with a 94.9% rate (111 of 117) of successful clip implantation. Baseline characteristics and comorbidities included NYHA Class III/IV (74%), left ventricular ejection fraction (LVEF) <40% (9%), prior cardiac surgery (24%) and prior myocardial infarction (MI) (22%). Mean logEuroSCORE I was 15.5 ± 13.3%. Mortalities at 30 days and 12 months were 6.0 and 17.1%, respectively. At 12 months, 74.6% (53 of 71) of patients in follow-up achieved MR ≤grade 2+ and 80.8% (63 of 78) were in NYHA functional class I/II. Both Minnesota Living with Heart Failure questionnaire (MLHFQ) scores and 6MWT distance improved significantly at 12 months compared with baseline (P = 0.03 and P < 0.0001, respectively). The MitraClip procedure resulted in significant reductions in MR and improvements in clinical outcomes at 12 months in selected patients with severe DMR. MitraClip therapy may serve as a complementary non-surgical therapeutic option for DMR patients who are considered at high risk or ineligible for surgery by an inter-disciplinary dedicated heart team. Interventional treatment should be indicated following the discussion of patients in an inter-disciplinary conference of cardiologists and cardiac surgeons as suggested by current international guidelines.
    European journal of cardio-thoracic surgery: official journal of the European Association for Cardio-thoracic Surgery 07/2013; · 2.40 Impact Factor
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    ABSTRACT: In current practice the MitraClip® procedure is increasingly being used for patients unsuitable or at high risk for cardiac surgery. This article initially describes the patient groups that are suitable for percutaneous edge-to-edge repair. For this purpose the echocardiographic criteria for severe mitral regurgitation are first characterized and treatment algorithms for patients with primary as well as secondary mitral regurgitation according to current guidelines are illustrated. Basic anatomical requirements for the successful implantation of a MitraClip® are described and a distinction is made between various valve morphologies ranging from optimal to unsuitable anatomical conditions. Finally, three patient groups eligible for percutaneous edge-to-edge repair considering clinical and anatomical criteria are defined: (1) optimal for MitraClip®, (2) MitraClip® could be considered and (3) MitraClip® only in exceptional cases.
    Herz 06/2013; · 0.78 Impact Factor

Publication Stats

4k Citations
1,226.69 Total Impact Points

Institutions

  • 2001–2014
    • Technische Universität München
      • Medizinische Klinik und Poliklinik II
      München, Bavaria, Germany
  • 1995–2014
    • Deutsches Herzzentrum München
      • • Klinik für Herz- und Kreislauferkrankungen
      • • Department of Cardiovascular Surgery
      München, Bavaria, Germany
  • 2013
    • University of British Columbia - Vancouver
      Vancouver, British Columbia, Canada
    • Henry Ford Hospital
      Detroit, Michigan, United States
  • 2012–2013
    • University Hospital München
      München, Bavaria, Germany
    • Emory University
      • School of Medicine
      Atlanta, GA, United States
    • Brigham and Women's Hospital
      • Center for Brain Mind Medicine
      Boston, MA, United States
  • 2001–2013
    • Cedars-Sinai Medical Center
      • Cedars Sinai Medical Center
      Los Angeles, CA, United States
  • 2011
    • University Hospital Regensburg
      • Klinik und Poliklinik für Innere Medizin II
      Regensburg, Bavaria, Germany
    • Walter Reed National Military Medical Center
      Washington, Washington, D.C., United States
  • 1996
    • Hannover Medical School
      • Department of Cardiology and Angiology
      Hannover, Lower Saxony, Germany