Jörg Hausleiter

Intraaortic balloon support for myocardial infarction with cardiogenic shock.

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.).

Estimated radiation dose associated with cardiac CT angiography.

CONTEXT Cardiac computed tomography (CT) angiography (CCTA) has emerged as a useful diagnostic imaging modality in the assessment of coronary artery disease. However, the potential risks due to exposure to ionizing radiation associated with CCTA have raised concerns. OBJECTIVES To estimate the radiation dose of CCTA in routine clinical practice as well as the association of currently available strategies with dose reduction and to identify the independent factors contributing to radiation dose. DESIGN, SETTING, AND PATIENTS A cross-sectional, international, multicenter, observational study (50 study sites: 21 university hospitals and 29 community hospitals) of estimated radiation dose in 1965 patients undergoing CCTA between February and December 2007. Linear regression analysis was used to identify independent predictors associated with dose. MAIN OUTCOME MEASURE Dose-length product (DLP) of CCTA. RESULTS The median DLP of 1965 CCTA examinations performed at 50 study sites was 885 mGy x cm (interquartile range, 568-1259 mGy x cm), which corresponds to an estimated radiation dose of 12 mSv (or 1.2 x the dose of an abdominal CT study or 600 chest x-rays). A high variability in DLP was observed between study sites (range of median DLPs per site, 331-2146 mGy x cm). Independent factors associated with radiation dose were patient weight (relative effect on DLP, 5%; 95% confidence interval [CI], 4%-6%), absence of stable sinus rhythm (10%; 95% CI, 2%-19%), scan length (5%; 95% CI, 4%-6%), electrocardiographically controlled tube current modulation (-25%; 95% CI, -23% to -28%; applied in 73% of patients), 100-kV tube voltage (-46%; 95% CI, -42% to -51%; applied in 5% of patients), sequential scanning (-78%; 95% CI, -77% to -79%; applied in 6% of patients), experience in cardiac CT (-1%; 95% CI, -1% to 0%), number of CCTAs per month (0%; 95% CI, 0%-1%), and type of 64-slice CT system (for highest vs lowest dose system, 97%; 95% CI, 88%-106%). Algorithms for dose reduction were not associated with deteriorated diagnostic image quality in this observational study. CONCLUSIONS Median doses of CCTA differ significantly between study sites and CT systems. Effective strategies to reduce radiation dose are available but some strategies are not frequently used. The comparable diagnostic image quality may support an increased use of dose-saving strategies in adequately selected patients.

Radiation dose estimates from cardiac multislice computed tomography in daily practice: impact of different scanning protocols on effective dose estimates.

Background— Multislice computed tomography angiography (CTA) is a promising technology for imaging patients with suspected coronary artery disease. Compared with 16-slice CTA, the improved spatial and temporal resolution of 64-slice CTA (0.6- versus 1.0-mm slice thickness and 330- versus 420-ms gantry rotation time) is associated with an increase in radiation dose. The objective of this retrospective investigation was to compare the estimated dose received during 16- and 64-slice CTA in daily practice and to investigate the impact of different scan protocols on dose and image quality. Methods and Results— Radiation dose was estimated for 1035 patients undergoing coronary CTA. Scanning algorithms with and without an ECG-dependent dose modulation and with a reduced tube voltage were investigated on dose estimates and image quality. In the entire patient cohort, radiation dose estimates were 6.4±1.9 and 11.0±4.1 mSv for 16- and 64-slice CTA, respectively (P<0.01). The reduction in radiation dose estimates ranged between 37% and 40% and between 53% and 64% with the use of ECG-dependent dose modulation and with the combined use of the dose modulation and a reduced tube voltage, respectively. The reduction in dose estimates was not associated with a reduction in diagnostic image quality as assessed by the signal-to-noise ratio and by the frequency of coronary segments with diagnostic image quality. Conclusions— The increase in spatial and temporal resolution with 64-slice CTA is associated with an increased radiation dose for coronary CTA. Dose-saving algorithms are very effective in reducing radiation exposure and should be used whenever possible.

Predictive Factors of Restenosis After Coronary Stent Placement

OBJECTIVES The objective of this study was to identify clinical, lesional and procedural factors that can predict restenosis after coronary stent placement. BACKGROUND Coronary stent placement reduces the restenosis rate compared with that after percutaneous transluminal coronary angioplasty (PTCA). However, restenosis remains an unresolved issue, and identification of its predictive factors may allow further insight into the underlying process. METHODS All patients with successful coronary stent placement were eligible for this study unless they had had a major adverse cardiac event during the 1st 30 days after the procedure. Of the 1,349 eligible patients (1,753 lesions), follow-up angiography at 6 months was performed in 80.4% (1,084 patients, 1,399 lesions). Demographic, clinical, lesional and procedural data were prospectively recorded and analyzed for any predictive power for the occurrence of late restenosis after stenting. Restenosis was evaluated by using three outcomes at follow-up: binary restenosis as a diameter stenosis > or =50%, late lumen loss as lumen diameter reduction and target lesion revascularization (TLR) as any repeat PTCA or coronary artery bypass surgery involving the stented lesion. RESULTS Multivariate analysis demonstrated that diabetes mellitus, placement of multiple stents and minimal lumen diameter (MLD) immediately after stenting were the strongest predictors of restenosis. Diabetes increased the risk of binary restenosis with an odds ratio (OR) [95% confidence interval] of 1.86 [1.56 to 2.16] and the risk of TLR with an OR of 1.45 [1.11 to 1.80]. Multiple stents increased the risk of binary restenosis with an OR of 1.81 [1.55 to 2.06] and that of TLR with an OR of 1.94 [1.66 to 2.22]. An MLD <3 mm at the end of the procedure augmented the risk of binary restenosis with an OR of 1.81 [1.55 to 2.06] and that of TLR with an OR of 2.05 [1.77 to 2.34]. Classification and regression tree analysis demonstrated that the incidence of restenosis may be as low as 16% for a lesion without any of these risk factors and as high as 59% for a lesion with a combination of these risk factors. CONCLUSIONS Diabetes, multiple stents and smaller final MLD are strong predictors of restenosis after coronary stent placement. Achieving an optimal result with a minimal number of stents during the procedure may significantly reduce this risk even in patients with adverse clinical characteristics such as diabetes.

Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial

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 benefit 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 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. 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 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. INTERPRETATION In patients undergoing early revascularisation 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.

SCCT guidelines on radiation dose and dose-optimization strategies in cardiovascular CT

Over the last few years, computed tomography (CT) has developed into a standard clinical test for a variety of cardiovascular conditions. The emergence of cardiovascular CT during a period of dramatic increase in radiation exposure to the population from medical procedures and heightened concern about the subsequent potential cancer risk has led to intense scrutiny of the radiation burden of this new technique. This has hastened the development and implementation of dose reduction tools and prompted closer monitoring of patient dose. In an effort to aid the cardiovascular CT community in incorporating patient-centered radiation dose optimization and monitoring strategies into standard practice, the Society of Cardiovascular Computed Tomography has produced a guideline document to review available data and provide recommendations regarding interpretation of radiation dose indices and predictors of risk, appropriate use of scanner acquisition modes and settings, development of algorithms for dose optimization, and establishment of procedures for dose monitoring.

SCCT expert consensus document on computed tomography imaging before transcatheter aortic valve implantation (TAVI)/transcatheter aortic valve replacement (TAVR).

Computed tomography (CT) plays an important role in the workup of patients who are candidates for implantation of a catheter-based aortic valve, a procedure referred to as transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR). Contrast-enhanced CT imaging provides information on the suitability of the peripheral access vessels to accommodate the relatively large sheaths necessary to introduce the prosthesis. CT imaging also provides accurate dimensions of the ascending aorta, aortic root, and aortic annulus which are of importance for prosthesis sizing, and initial data indicate that compared with echocardiographic sizing, CT-based sizing of the prosthesis may lead to better results for postprocedural aortic valve regurgitation. Finally, CT permits one to predict appropriate fluoroscopic projections which are oriented orthogonal to the aortic valve plane. This consensus document provides recommendations about the use of CT imaging in patients scheduled for TAVR/TAVI, including data acquisition, interpretation, and reporting.

Abciximab and heparin versus bivalirudin for non-ST-elevation myocardial infarction.

BACKGROUND The combination of glycoprotein IIb/IIIa inhibitors and heparin has not been compared with bivalirudin in studies specifically involving patients with non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI). We compared the two treatments in this patient population. METHODS Immediately before PCI, we randomly assigned, in a double-blind manner, 1721 patients with acute non-ST-segment elevation myocardial infarction to receive abciximab plus unfractionated heparin (861 patients) or bivalirudin (860 patients). The study tested the hypothesis that abciximab and heparin would be superior to bivalirudin with respect to the primary composite end point of death, large recurrent myocardial infarction, urgent target-vessel revascularization, or major bleeding within 30 days. Secondary end points included the composite of death, any recurrent myocardial infarction, or urgent target-vessel revascularization (efficacy end point) and major bleeding (safety end point) within 30 days. RESULTS The primary end point occurred in 10.9% of the patients in the abciximab group (94 patients) and in 11.0% in the bivalirudin group (95 patients) (relative risk with abciximab, 0.99; 95% confidence interval [CI], 0.74 to 1.32; P=0.94). Death, any recurrent myocardial infarction, or urgent target-vessel revascularization occurred in 12.8% of the patients in the abciximab group (110 patients) and in 13.4% in the bivalirudin group (115 patients) (relative risk, 0.96; 95% CI, 0.74 to 1.25; P=0.76). Major bleeding occurred in 4.6% of the patients in the abciximab group (40 patients) as compared with 2.6% in the bivalirudin group (22 patients) (relative risk, 1.84; 95% CI, 1.10 to 3.07; P=0.02). CONCLUSIONS Abciximab and unfractionated heparin, as compared with bivalirudin, failed to reduce the rate of the primary end point and increased the risk of bleeding among patients with non-ST-segment elevation myocardial infarction who were undergoing PCI. (Funded by Nycomed Pharma and others; ISAR-REACT 4 ClinicalTrials.gov number, NCT00373451.).

Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial

BACKGROUND The best way to manage restenosis in patients who have previously received a drug-eluting stent is unknown. We investigated the efficacy of paclitaxel-eluting balloons (PEB), paclitaxel-eluting stents (PES), and balloon angioplasty in these patients. METHODS In this randomised, open-label trial, we enrolled patients older than 18 years with restenosis of at least 50% after implantation of any limus-eluting stent at three centres in Germany between Aug 3, 2009, and Oct 27, 2011. Patients were randomly assigned (1:1:1; stratified according to centre) to receive PEB, PES, or balloon angioplasty alone by means of sealed, opaque envelopes containing a computer-generated sequence. Patients and investigators were not masked to treatment allocation, but events and angiograms were assessed by individuals who were masked. The primary endpoint was diameter stenosis at follow-up angiography at 6-8 months. Primary analysis was done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00987324. FINDINGS We enrolled 402 patients, of whom 137 (34%) were assigned to PEB, 131 (33%) to PES, and 134 (33%) to balloon angioplasty. Follow-up angiography at 6-8 months was available for 338 (84%) patients. PEB was non-inferior to PES in terms of diameter stenosis (38·0% [SD 21·5] vs 37·4% [21·8]; difference 0·6%, one-sided 95% CI 4·9%; p(non-inferiority)=0·007; non-inferiority margin of 7%). Findings were consistent in per-protocol analysis (p(non-inferiority)=0·011). PEB and PES were superior to balloon angioplasty alone (54·1% [25·0]; p(superiority)<0·0001 for both comparisons). Frequency of death, myocardial infarction, or target lesion thrombosis did not differ between groups. INTERPRETATION By obviating the need for additional stent implantation, PEB could be a useful treatment for patients with restenosis after implantation of a drug-eluting stent. FUNDING Deutsches Herzzentrum.

Prognostic value of coronary computed tomographic angiography for prediction of cardiac events in patients with suspected coronary artery disease.

OBJECTIVES We assessed the rate of cardiac events after detection or exclusion of obstructive coronary artery disease (CAD) by coronary computed tomography angiography (CCTA). BACKGROUND Several studies have demonstrated a high diagnostic accuracy of CCTA for detection of obstructive CAD compared with invasive angiography, but data regarding the clinical prognostic value of CCTA are limited. METHODS In all, 1,256 consecutive patients with suspected CAD undergoing 64-slice CCTA in our institution between October 2004 and September 2006 were observed prospectively for the occurrence of severe cardiac events (cardiac death, myocardial infarction, or unstable angina requiring hospitalization: primary study end point) and all cardiac events (additionally including revascularization >90 days after CCTA). The observed rate of all cardiac events was compared with the event rate predicted by the Framingham risk score. Obstructive CAD was defined as > or = 50% diameter stenosis in any coronary artery. RESULTS During a median follow-up of 18 months (interquartile range 14 to 25 months), the overall rates of severe and all cardiac events were 0.6% and 1.8%, respectively. In 802 patients without obstructive CAD, there were 4 cardiac events, of which 1 was severe, whereas in 348 patients with obstructive CAD, there were 17 cardiac events, of which 5 were severe. The difference between the 2 groups was highly significant both for severe events (odds ratio: 17.3, 95% confidence interval: 3.6 to 82.5) and for all cardiac events (odds ratio: 16.1, 95% confidence interval: 7.2 to 36.0; both p < 0.001). The rate of all cardiac events in patients without obstructive CAD was significantly lower than predicted by the Framingham risk score (p = 0.01). CONCLUSIONS In patients with suspected CAD, CCTA has a significant prognostic impact on the prediction of cardiac events for the subsequent 18 months. The exclusion of obstructive CAD by CCTA identifies a patient population with an event risk lower than predicted by conventional risk factors.