Health economic evaluation of the use of drug-eluting stents : First results from the Drug-Eluting Stent Registry (DES.de).

OBJECTIVE: The purpose of the economic evaluation of the German Drug-Eluting Stent (DES) registry includes the investigation of the economic impact and cost-effectiveness of DES compared to bare-metal stents (BMS) and between paclitaxel-eluting (PES) and sirolimus-eluting stents (SES). Here, methodology and initial results are presented. METHODS: Patients were recruited in 2005 and 2006 in 87 centres across Germany. Selection of PES, SES, or BMS was made at the discretion of the cardiologists in charge. Clinical, economic, and quality of life (QoL) data were collected at baseline and up to 12 months. Group comparisons were conducted using Fisher's exact and t test. RESULTS: Overall, 3,930 patients were enrolled: 3,471 (75% male, 65 ± 11 years) received DES and 458 (74% male, 67 ± 11 years) BMS. Among the DES patients, 1,821 received PES (75% male, 65 ± 10 years) and 1,600 SES (76% male, 65 ± 11 years). There were baseline differences in clinical and procedural characteristics but not in QoL. During the hospital stay, major adverse cardiac and cerebrovascular events occurred in 1.6% of DES (PES 1.9%, SES 1.1%) and 2.2% of BMS patients (BMS vs. DES, PES, and SES p = 0.327, 0.706, and 0.098, respectively). Hospital treatment costs were 4,989 ± 1,284  and 3,609 ± 924 , respectively, in DES and BMS patients (p < 0.001) with no significant difference between PES and SES. CONCLUSION: The economic evaluation of the large DES registry demonstrates increased initial hospitalisation costs associated with DES compared to BMS. Further analysis of the economic impact and cost-effectiveness of DES will provide estimates on large "real world" patient populations for decision makers and aid in reimbursement decisions of DES within the German and other health care systems.

[CRT in atrial fibrillation--methodical and apparatus options in decision-making]. / CRT bei Vorhofflimmern. Methodische und apparative Optionen zur Entscheidungsfindung.

Heart failure and atrial fibrillation often coexist, especially with increasing degree of heart failure severity. Under this constellation, the advantage of cardiac resynchronization therapy (CRT) is still under discussion and displayed as an unresolved problem in the guidelines for cardiac stimulation and resynchronization. If ventricular desynchronization can be documented and response to CRT can be expected, the challenge is to interoperatively seek the best left ventricular electrode position and to postoperatively optimize the device in order to achieve the best therapy performance. This situation encourages the development of individualized methods and to utilize innovative apparatus features in order to consolidate individual decisions and to optimize CRT in heart failure with atrial fibrillation.

[Guideline-conforming interventional treatment of acute ST-segment elevation myocardial infarction in rural areas using network collaboration]. / Leitlinienkonforme interventionelle Therapie des akuten ST-Hebungsinfarktes in ländlichen Regionen durch Netzwerkbildung.

BACKGROUND AND OBJECTIVES: Therapy of acute myocardial infarction demands rapid and complete myocardial reperfusion. Primary percutaneous coronary intervention (PCI) performed is superior to thrombolytic therapy in reducing mortality, non-fatal reinfarction and stroke, but is not available in rural Germany. PATIENTS AND METHODS: : From 8/2001 to 12/2002 322 patients with STEMI were treated by PCI with standardized therapeutic guidelines within a regional infarction-network comprising one interventional centre and 7 community hospitals without PCI facilities. 160 patients were relocated (transferred) from a community hospital without PCI facilities (transfer group, 63.4 yrs., 71.8 % men); 162 patients were admitted directly to the interventional centre (centre group, 61.7 yrs., 73.8 % men). The interval from onset of symptoms to first medical contact was 205 minutes in the transfer group, and 195 minutes in the centre group. 7.8 % of the centre group and 7.2 % of the transfer group patients were in cardiogenic shock. 95 % of patients have completed a 6-month's follow-up. RESULTS: In the transfer group median transportation time to PCI was 54 minutes. PCI of the infarct-related artery (IRA) was performed in 95.1 % of transferred patients after transfer and in 94.1 % of patients with direct admission. In addition 96 % of all patients received a GP IIb/IIIa receptor inhibitor. In case of pre-interventional application of the GP IIb/IIIa receptor inhibitor 22.3 % of patients revealed normal (TIMI-3) flow of the IRA before PCI, compared to 14.9 % TIMI-3 flow with 5000 IE Heparin/500 mg aspirin alone (p < 0.05). After PCI normalized flow in the IRA was documented in 87.5 % after direct admission and 86.3 % after transfer. No differences between groups were shown with respect to infarct size (transfer vs. centre: CK 2482 vs. 2481 U/I; CKMB 302 vs. 264 U/I), mortality (30 days: 5.3 vs. 5.2 %, 6 months: 7.3 vs. 7.1 %); NYHA (1.41 vs. 1.43) and left ventricular ejection fraction (0.41 vs. 0.43). CONCLUSIONS: The organization of a regional infarction-network with logistic alliance of community hospitals with one experienced interventional centre ensures timely PCI for patients with STEMI according to present guidelines even in rural areas.

Importance of dural ectasia in phenotypic assessment of Marfan's syndrome.

BACKGROUND: Early identification of Marfan's syndrome is fundamental in the prevention of aortic dilatation, but the wide phenotypic expression of the disorder makes the clinical diagnosis very difficult. Dural ectasia has been classified as a major diagnostic criterion; however, its prevalence is not known. We aimed to identify the true prevalence of dural ectasia in Marfan's syndrome, and to investigate its relation to aortic pathology. METHODS: A magnetic-resonance-imaging (MRI) study of the thoracic aorta and of the lumbosacral spine was done in an inclusive series of 83 patients with Marfan's syndrome to assess the presence and degree of dural ectasia and aortic involvement; 12 patients were younger than 18 years. 100 individuals who underwent MRI of the lumbar spine for routine clinical indications represented the control group; none of them had any potential causes for dural ectasia. FINDINGS: Dural ectasia was identified in 76 (92%) patients and none of the control group. The severity of dural ectasia was related to age; the mean (SD) age of patients with mild dural ectasia was 26 years (14) whereas that of those with severe disease (meningocele) was 36 years (9) (p=0.038). 11 of 12 patients younger than 18 years had dural ectasia. No association was found between aortic dilatation and dural ectasia. INTERPRETATION: Dural ectasia is a highly characteristic sign of Marfan's syndrome, even at an early age.

[Visual assessment or quantitative measurement of coronary stenoses: significance for "prima vista"-PTCA]. / Visuelle Einschätzung oder quantitative Vermessung von Koronarstenosen: Bedeutung für die "prima vista"-PTCA.

In 300 patients with 339 coronary lesions the percent diameter stenosis (%-DS) was assessed both by visual estimation and by digital quantitative coronary angiography (DQCA) by use of an on-line computer work-station. The decision for coronary angioplasty in the same setting ("prima vista"-PTCA) was based on history, evidence of ischemia and visual estimation of %-DS. DQCA measurements of the 339 stenoses revealed a normal distribution of lesion severity with a mean of 58.4 +/- 11.3%. In contrast to DQCA visual estimation led to a bimodal distribution with a nadir at approximately 55% between two peaks at approximately 45% and approximately 75% and a mean of 70.5 +/- 19.6%. Visual estimation underestimated lesions in the range of 30-55% and overestimated the %-DS between 55-99%. Visual estimation revealed a %-DS > or = 60% in 251 stenoses (74.0%) of the 339 lesions, an estimate that led to subsequent "prima vista"-PTCA. Conversely, DQCA revealed only 184 stenoses (54.3%) with a %-DS > or = 60%; thus, 86 stenoses (25.3%) did not meet the morphologic indication criteria for PTCA. The bimodal distribution of stenosis severity according to visual analysis with an overestimation of borderline stenosis severity reflects at tendency for "self-referral" of patients for PTCA. DQCA serves as an objective tool in the decision-making process for PTCA and may reduce "cosmetic" interventions or justify to defer PTCA. Especially in the selection process for "prima vista"-PTCA DQCA-quantification of stenosis severity is recommended.

[Impairment of myocardial perfusion reserve in microvascular angina (syndrome X): assessment by 99mTc-MIBI-SPECT]. / Einschränkung der myokardialen Perfusions-reserve bei Mikrovaskular-Angina (Syndrom X): Nachweis durch 99mTc-MIBI-SPECT.

AIM: In 22 patients with typical chest pain and normal coronary arteries (microvascular angina, syndrome X) 99mTc-MIBI-SPECT was examined in regard to assess impairment of myocardial perfusion reserve. METHOD: The study was performed with 99mTc-MIBI-SPECT at rest and under vasodilation with dipyridamole. The findings were compared with a normal database. A normal perfusion reserve was said to be an increase > 20% of the 99mTc-MIBI-activity. RESULTS: In 2/22 (9%) of the patients the perfusion reserve lay > 20% i.e. 37%. In 91% of the patients a diminution or even decrease of the perfusion was to be seen. From these 9/22 (41%) of the patients showed a diminution of the 99mTc-MIBI-uptake by 6%. 1/22 patients had a decrease of the perfusion under vasodilation with dipyridamole i.e. a lower activity of 99mTc-MIBI by 13% CONCLUSION: Vasodilation 99mTc-MIBI-SPECT offers good imaging quality and enables semi-quantitative assessment of myocardial perfusion reserve in patients with microvascular angina.

Assessment of post-infarction jeopardized myocardium by vasodilation--thallium-201 tomography: impact on risk stratification.

For the purpose of risk stratification 80 consecutive patients (mean age 58 +/- 7 years) with a chest pain syndrome after documented myocardial infarction underwent tomographic vasodilation-redistribution thallium-201 perfusion imaging, using 0.56 mg kg-1 intravenous dipyridamole. Tomograms were analysed for size and location of reversible and fixed perfusion defects and correlated to angiographic characteristics, left ventricular ejection fraction and wall motion, collateral status and 1-year prognosis, as measured by cardiac events within 12 months. No serious side-effects were noted with the diagnostic use of intravenous dipyridamole. According to the perfusion pattern three subgroups of post-infarction patients were identified: (1) by ischaemia at a distance with redistribution in non-infarct related territories (n = 48); (2) by peri-infarctional ischaemia with redistribution in the territory of the 'infarct artery' (n = 9); and (3) by exclusively fixed defects without redistribution (n = 23). Ischaemia at a distance was associated with a larger reversible defect than peri-infarctional ischaemia (P less than 0.05) and the pattern without redistribution (P less than 0.005); the fixed defect size, however, was similar in all three subgroups. In addition, the severity of coronary artery disease (Gensini score and number of diseased vessels) and the degree of collateralization was higher in the presence of a redistribution pattern (P less than 0.05), although no significant differences in global and regional function were noted as a function of thallium-201 redistribution.(ABSTRACT TRUNCATED AT 250 WORDS)

Non-invasive assessment of end-systolic pressure-length and stress-shortening relationships in normal individuals: significance of different loading conditions induced by methoxamine and angiotensin II.

To evaluate whether the end-systolic pressure-dimension and stress-shortening relations are influenced by the drugs used for their assessment, we analysed the effects of angiotensin II (N = 30) and methoxamine (N = 10) in normal individuals. Serial measurements of left ventricular dimensions and wall thickness were performed by M-mode echocardiography; the end-systolic pressure was assessed by indirect, calibrated carotid pulse tracings. The end-diastolic dimension, which reflects preload, remained unchanged during the afterload challenge using angiotensin II, but increased significantly using methoxamine (P less than 0.001). Significant differences due to the agent used were observed for the end-systolic pressure-dimension relationship (P less than 0.002), the relation between end-systolic wall stress and fractional shortening (P less than 0.0002), and the relation between end-systolic wall stress and mean fibre shortening velocity (P less than 0.02). The extrapolated end-systolic dimension D0 at zero end-systolic pressure was significantly shifted to the left when using angiotensin II (P less than 0.02); this is considered to be due to its negligible effect on preload. Our data suggest that the assessment of the end-systolic pressure-dimension and stress-shortening relationships depends significantly on drug specific effects and the variation of preload during the afterload challenge. Based on these results, the use of angiotensin II is emphasized for the assessment of the end-systolic pressure-dimension and stress-shortening relationships.

Hypertrophic cardiomyopathy: non-invasive assessment of diastolic and systolic functional parameters in relation to heart rate.

Hypertrophic cardiomyopathy (HC) is characterized by reduced left ventricular compliance and subsequent filling abnormalities. To study the pathophysiologic changes in parameters of left ventricular systolic and diastolic performance as a function of increasing heart rate 14 patients with HC (32 +/- 12 yrs; 11 M, 4 F) and 4 normal individuals were subjected to equilibrium radionuclide ventriculography (99mTc-labelled red blood cells) at rest and during incremental right atrial pacing; heart rate was increased in steps of 20 beats per min from basal state to the individual symptom-limited endpoint. Mean symptom-limited heart rate was 141 +/- 28 in HC and 160 in normals (p less than .01.). At each pacing level filling and ejection parameters as well as the left ventricular endsystolic (LVESV) and enddiastolic volume (LVEDV) were determined relative to resting volumes at a heart rate of 78 +/- 8. At the individual maximal pacing rate HC revealed a decline in LVEDV to 61 +/- 4% (p less than .001) and an increase in LVESV to 117 +/- 14% (p less than .001) resulting in decreasing ejection fractions at heart rates above 120. Peak LV filling rates initially increased but subsequently decreased steeply at heart rates above 100; peak LV ejection rates in HC showed a similar pattern with increasing frequency. Time intervals to peak ejection and peak filling rate did not differ from normal. Thus, patients with HC demonstrated combined left ventricular diastolic and systolic abnormalities with increasing heart rate leading into a low-input low-output circulatory state. This probably explains not only the symptoms associated with HC, but also supports the concept of "hemodynamic syncope" in HC.