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.

[Position paper nuclear cardiology: update 2008]. / Positionsbericht Nuklearkardiologie Update 2008: Aktueller Stand der szintigraphischen Methodik.

Nuclear cardiology is well established in clinical diagnostic algorithms for many years. This is an update 2008 of the first common position paper of the German Association of Nuclear Medicine and the German Association of Cardiology, Heart and Circulation Research published in 2001 aiming at an overview of state-of-the-art scintigraphic methods.

[Arguments in favor of Integrated Health Care as regular health care provision in cardiology]. / Argumente für die Integrierte Versorgung als Regelversorgung in der Kardiologie.

Patients are not outpatients or inpatients, they are ill or healthy. Integrated Health Care provides a real chance to bring scientific innovations quickly from the laboratory to patients--and being paid for that. Although guidelines therefore are no compulsory exercise, they are tools to implement evidence-based use of innovative medical means. Health care providers should be reluctant to agree in guarantees for the success of medical therapies, since medical decisions may be influenced in different ways by that. Bureaucracy may hinder the spreading of Integrated Health Care; therefore simple regulations should be preferred. Reimbursement should not be designed according to conventional systems for outpatient or inpatient care, but as defined sums of money. That makes people sure to know what kind of contract they have agreed in.

[Impact of both cardiac-CT and cardiac-MR on the assessment of coronary risk]. / Stellenwert von Kardio-CT und Kardio-MR zur Bestimmung des koronaren Risikos.

Today's definition of coronary artery disease (CAD) comprises two forms: obstructive and non-obstructive CAD. The 31-72% chance of a life-threatening event-like a myocardial infarction-with non-obstructive CAD is well documented in numerous studies. The objective in modern strategies of diagnosis and therapy should therefore be expedient identification of patients at high risk for coronary events, who will benefit from a customized therapy. Before initiating diagnostic procedures of CAD, a well defined strategy should be pursued. There are two possible primary objectives: ASSESSMENT OF THE INDIVIDUAL RISK FOR A CORONARY EVENT: Assessment of the individual "absolute" risk for a coronary event is not possible using single traditional risk factors. The individual risk can be estimated by integrating several of the traditional risk factors into a scoring system. These so-called risk scores (e.g. Framingham score and Procam score), however, have been associated with shortcomings: insufficient discrimination of high-risk from low-risk individuals. The calcium score has therefore become increasingly established; this Agatston score is independent of the traditional risk factors, so there is no correlation between Agatston and Procam scores. Today, the calcium score is considered the superior test for identifying individuals at high risk for a coronary event and its use is recommended by the European Society of Cardiology (ESC) guidelines for prevention of cardiovascular diseases. PROOF OR EXCLUSION OF A HEMODYNAMICALLY SIGNIFICANT CORONARY STENOSIS: Another concept is the definitive proof or exclusion of a hemodynamically "significant" coronary narrowing. The probability of an obstructive CAD is traditionally assessed by the type of chest pain, age, gender and stress-ECG. In patients with a low probability of an obstructive CAD, cardiac catheterization is not indicated, whereas in patients with a high probability of a hemodynamically significant coronary stenosis, an invasive strategy should be performed. Since non-invasive coronary angiography (CTA) with cardiac-CT has been shown to provide a high negative predictive value, CTA (with good imaging quality) is suitable for ruling out a significant obstructive CAD in the group at intermediate risk for an obstructive CAD. Another approach could be a functional test to initially prove a relevant, inducible myocardial ischemia: In a large cohort it was shown that patients will only prognostically benefit from revascularization procedures if the ischemic myocardial area is greater than 10%. Therefore, the assessment of the extent of myocardial ischemia is the domain of modern stress imaging tests. Stress-echocardiography and myocardial scintigraphy have almost the same sensitivity (74-80%, 84-90%, respectively) and specificity (84-89%, 77-86%, respectively), which are considerably higher than for stress-ECG. Cardiac MR is most suitable for the assessment of myocardial perfusion, because it traces the first pass dynamics of gadolinium at rest and during stress in reproducible slices at an acceptable spatial and a high temporal resolution without ionizing radiation. Whether the non-invasive coronary angiography with cardiac-CT and the Adenosin-perfusion imaging with cardiac-MR will completely replace diagnostic cardiac catheterization and stress-echocardiography as well as myocardial scintigraphy remains to be evaluated in further studies.

[When are drug-eluting stents effective? A critical analysis of the presently available data]. / Wann sind Drug-eluting Stents als wirksam zu bezeichnen? Eine kritische Analyse der aktuellen Datenlage.

The use of drugeluting stents (DES) has tackled the "Achilles' heel" of percutaneous coronary interventions (PCI) like no innovation before: the restenosis following initially successful PCI of de novo stenoses. Today, with DES, the pivotal clinical parameter TVF (target vessel failure) is in the upper single- digit range for "standard" lesions and 16% for long lesions. Numerous studies have assessed the effects of various antiproliferative and antiinflammatory substances, like Sirolimus, Tacrolimus, Everolimus, ABT-578, Biolimus, Paclitaxel, QP2 as well as of other drugs, like Dexamethasone, 17-beta-Estradiol, Batimastat, Actinomycin-D, Methotrexat, Angiopeptin, Tyrosinkinase inhibitors, Vincristin, Mitomycin, Cyclosporin, and also the C-myc antisense technology (Resten-NG, AVI-4126). At the time of this analysis, four DES are CE-certified and commercially available in Europe: The Cypher stent, releasing Sirolimus from a polymer (Cordis, J&J), the Taxus stent, releasing Paclitaxel from a polymer (Boston-Scientific), the V-Flex stent, releasing Paclitaxel without a polymer (Cook) and the Dexamet stent, releasing Dexamethasone from a PC coating (Abbott). Since more DES will be CE-certified soon, an increasing challenge vexes interventional cardiologists and health care providers: Which DES should be chosen for routine patient care?A prerequisite for assessing the efficacy of DES are randomized, controlled trials. Registries, even with strong monitoring, are limited by the known restrictions, comparing data to historical controls. At the time of this analysis, only three drugs had proven their efficacy in 13 randomized studies in 5669 patients: Paclitaxel, Sirolimus and Everolimus, with 3815 patients in Paclitaxel studies, 1748 patients in Sirolimus studies and 106 patients in Everolimus studies. For further analysis, it makes sense to divide the primary endpoints into non-clinical and clinical endpoints. Non-clinical primary endpoints are usually angiographic parameters, like the percentage of DS (diameter stenosis, ASPECT, ELUTES), the instent LLL (late lumen loss, RAVEL, FUTURE-II), the in-stent MLD (minimal lumen diameter, E-SIRIUS, C-SIRIUS) or, like in TAXUS-II, the IVUS-determined percentage of volume obstruction. Clinical primary endpoints were either MACE (major adverse cardiac events, TAXUS-I, FUTUREI), TVF (target vessel failure, DELIVER-I, SIRIUS) or TVR (target vessel revascularization, TAXUS-IV und TAXUS-VI). As ASPECT, ELUTES and DELIVER-I have shown, even a statistically significant effect on an angiographic primary endpoint does not necessarily translate into a significant clinical effect, which is completely absent in some such cases. Since it is not the goal of PCI to improve angiographic parameters but rather to improve patients' outcome, the choice of DES for routine treatment should be based on the results of randomized controlled studies with a clinical primary endpoint at an appropriate time interval. At the present time, these criteria have been met by only the Cypher and the Taxus stents.

[Immediate hemostasis of the femoral artery after heart catheterization: the present situation of closure systems]. / Sofortige Blutstillung der Arteria femoralis nach Herzkatheter: aktueller Stand der Verschlusssysteme.

The femoral approach is the most commonly used route for diagnostic cardiac catheterization and coronary interventions today. Manual compression and pressure bandages usually lead to immobilisation of the patient for several hours and may result in significant discomfort. Since the introduction of the first femoral closure device in 1991, many devices have proven their efficacy in significantly reducing time to hemostasis while simultaneously improving patient comfort. Twenty four closure device systems with different concepts are on the market, e. g. pure collagen, collagen + thrombin, collagen + anchor, vascular suture, hemostatic patches and pads, staples and more. The four predominantly used are Angio-Seal (46 %), Perclose (32 %), VasoSeal (14 %) and Duett (3 %). The effectiveness of all four systems has been proven in a prospective, randomized, controlled multicenter trial each. Efficacy and safety were analyzed using data from ten comparative studies in 8832 predominantly or exclusively interventional patients, however none of the closure systems proved to be superior. Fortunately, recent years have shown a trend toward a reduction in local complications by vascular closure devices compared to manual compression. Closure devices are thus becoming increasingly cost effective. Vascular closure systems should be preferred when the prolonged supine position is not tolerated, a protein IIb/IIIa-inhibitor was used during the procedure, or early discharge of patient is anticipated. In the presence of peripheral vascular disease, small diameter of the femoral vessels or stenotic lesions in the femoral artery, closure devices should be used with caution. Closure systems for immediate femoral puncture site hemostasis are now an important tool of invasive cardiology today.

Dedicated asthma center improves the quality of care and resource utilization for pediatric asthma: a multicenter study.

OBJECTIVES: To determine the relative effectiveness of pediatric asthma care among patients treated by a dedicated asthma center (AC) vs children who use the emergency department (ED) as a site of primary asthma care. METHODS: A retrospective case-control design was used. A random sample of AC cases was selected from a designated comprehensive AC over a 12-month period. Concurrent ED control patients were identified from all cases of pediatric asthma from five urban hospitals based on two or more ED visits. Cases and controls were matched (1:2) based on age and National Heart, Lung, and Blood Institute (NHLBI) asthma severity of illness classification. A telephone survey was administered to the caregivers of all enrolled patients in the study sample. RESULTS: Four elements of pediatric asthma care were examined: quality, access, hospital utilization, and functional impact of disease. Demographic data were similar between the ED cases and the AC controls. In terms of quality of care, the AC patients were more likely to use maintenance antiinflammatory medications, 60.2% vs 22.5% (OR = 5.3; 95% CI = 2.9 to 9.7) and more likely to be taking medications at school, 71.4% vs 48.1% (OR = 2.7; 95% CI = 1.5 to 4.7). In terms of access to care, the AC families were more likely to have a physician to call to assist with outpatient management, 98.2% vs 65.0% (OR = 25.3; 95% CI = 9.0 to 76.9). Frequent ED utilization (> or = 1 visit/month) was less likely in the AC patients, 9.2% vs 22.0% (OR = 0.35; 95% CI = 0.16 to 0.79) and school absenteeism was lower as well (9.5 +/- 6.7 days vs 16.6 +/- 10.3, p < 0.001). Additionally, the caregivers of the AC patients missed fewer workdays (4.7 +/- 2.8 vs 7.4 +/- 4.1; p = 0.03). CONCLUSIONS: Significant disparities in quality, access, resource utilization, and functional impact exist between AC and ED patients. Emergency physicians have a unique opportunity to improve the public health by directing ED patients toward pediatric AC treatment.

[2d Report on increasing volume of diagnostic and interventional heart catheterization in hospitals and private practice in Germany 1990-1999]. / 2. Bericht über die Mengenzunahme diagnostischer und interventioneller Herzkatheter im krankenhausärztlichen und vertragsärztlichen Bereich in Deutschland 1990-1999.

Despite all warnings from the German Ministry of Health, the healthcare insurances and the media, the number of diagnostic (DIAG) and therapeutic (PCI) cardiac catheterizations is continuously growing in hospitals and in private practices. From 1997 to 1999, the number of DIAG increased from 478837 to 561623 and PCI from 135925 to 166132. The average number of DIAG per institution decreased from 1482 in 1997 to 1324 in 1999 and the average number of PCI from 535 to 479. The number of DIAG-performing hospitals increased from 256 to 315 and that of DIAG-performing private practices from 67 to 109. The number of PCI-performing hospitals increased from 211 to 278 and the corresponding private practice locations from 43 to 69. In 1999, 18% of all DIAG and 15% of all PCI in Germany was performed in private practice. Since 1994, the average number of DIAG per private practice continuously decreased as well as the average number of PCI per private practice since 1997. This decrease was more pronounced in private practice (DIAG 378/lab and PCI 111/lab) than in hospitals (DIAG 68/lab and PCI 35/lab). Possible reasons for this trend are an increasing number of low volume centers, a more rigid indication for DIAG and PCI due to quality control programs, and the reduction of reimbursement incentives for social healthcare insured patients in private practice. The real optimal need for DIAG and PCI in Germany, however, has to be determined.

Rapid hemostasis of arterial puncture sites with collagen in patients undergoing diagnostic and interventional cardiac catheterization.

Despite the continuous reduction of sheath sizes in diagnostic and interventional cardiac catheterizations and the discontinuation of coumadin use after coronary stent implantation, a challenging role remains for hemostatic devices in the sealing femoral puncture sites. Since the introduction of the vascular hemostatic device (VHD) in 1991 and the hemostatic puncture closing device (HPCD) in 1992, numerous studies investigating these devices have been published. The deployment success rates reported in 2,292 patients for VHD is 97%, ranging from 88 to 100%. For HPCD, the mean deployment success rate resulting from 622 published patients leads to an identical result of 97%, ranging between 91 and 100%. For time to hemostasis, data have been analyzed according to the four different clinical situations, depending on level of anticoagulation (none or full) and the time of sheath removal (immediate or delayed). In randomized studies, when compared with the manual control groups, both devices revealed a statistically significant reduction in time to hemostasis: 12 to 16 minutes less for diagnostic catheterization and 14 to 30 minutes less for PTCA. As for minor local complications, no clinically relevant differences seem to exist. None of these devices has been proven to reduce major local complications. Prospective trials addressing early mobilization after percutaneous transluminal coronary angioplasty and the cost effectiveness of arterial closure devices in defined subgroups are warranted.

[Waiting times and death on the waiting list for coronary artery bypass operation. Experiences in Munich with over 1,000 patients]. / Wartezeiten und Tod auf der Warteliste für eine koronare Bypass-Operation. Erfahrungen in München an über 1000 Patienten.

Short-term and long-term results are the classical parameters for quality assurance in coronary artery bypass graft surgery (CABGS). In contrast, waiting times and the inherent risks of waiting lists are usually neglected. Although the problem of "death on the waiting list" is generally known, related publications are scarce. Therefore, in January 1994, we started a prospective study to document the waiting times and the occurrence of severe complications in our patients waiting for CABGS. Between January 1, 1994 and July 31, 1996, we catheterized 1125 patients with indication for CABGS. 968 patients had social health insurance (SOCL); 157 patients were privately insured (PRIV). The urgency of CABGS was classified as "emergent", "ery urgent" and "less urgent" according to the clinical experience of the responsible cardiologists. All emergency cases could be operated the same day. 69% of the very urgent SOCL patients had to travel beyond the Munich area to be operated, while 84% of the respective PRIV patients were operated in Munich. SOCL patients were therefore separated from their families 4.3 times more frequently then PRIV. Not so urgent SOCL cases were separated from their families 1.8 times more often than PRIV. The mean waiting time for SOCL was 39.5 +/- 39.1 days in 1994, 34.9 +/- 31.5 days in 1995 and 22.7 +/- 16 days in 1996. The corresponding values of PRIV are 19.1 +/- 16.2, 19.8 +/- 14.1 and 17.2 +/- 12.6 days. The risk of dying while waiting for CABGS was 1.3% per month (15/1125). The reduction of waiting times by the factor of two between 1994 and 1996 did not, however, influence the death on the waiting list, because all deaths occurred within 4 weeks after diagnostic catheterization. Our results show that triage practices for patients requiring CABGS are not reliable. To minimize the risk of the "death on the waiting list", CABGS must be offered within a week after diagnostic coronary angiography, even for "elective" cases.

[Quality assurance in cardiology: Germany]. / Qualitätssicherung in der Kardiologie: Deutschland.

Quality assurance is a touchy subject: difficult to implement, time-demanding and expensive. The goal of quality assurance is to assist both the patients and the physicians. In addition to legal requirements, quality assurance is necessary for medical as well as economical reasons. It makes sense that the license to practice medicine does not automatically entail the right to perform all medical procedures; the development of new methods and the insights won from important scientific studies necessitates constant training. Furthermore, the decreasing allocation of funds for medical care combined with increased demand effected by new treatment methods and longer life expectancy force the development of instruments for specific and reasonable budgeting of medical expenditures. The primary goal of quality management in respect to economical regards must be the avoidance of unnecessary hospital admissions. But the patient must retain the right to choose the physician he prefers. The organization of the supervising structures in Germany is inconsistent: in 1995, a new Zentralstelle der Deutschen Arzteschaft zur Qualitätssicherung in der Medizin (German Physicians Headquarters for Quality Assurance in Medicine) was founded; it is proportionally staffed by representatives of the Bundesärztekammer (BAK, Federal Board of Physicians) and the Kassenärztliche Bundesvereinigung (KBV, Federal Commission of Panel Physicians). Furthermore, there is the Arbeitsgemeinschaft zur Förderung der Qualitätssicherung in der Medizin (Working Group for the Advancement of Quality Assurance in Medicine), in which the Bundesministerium für Gesundheit (Federal Ministry of Health) and the Kassenärztliche Vereinigung (KV, Public Health Insurance Providers) are represented. The KV is already seeing to it that stricter regulations govern physicians with private practice than those governing hospital physicians. There are three data banks existing on a voluntary basis for invasive diagnostic and therapy: a general, annual survey with baseline data from all German cardiac catheter laboratories; a data bank for storing records of PTCA's performed primarily in non-university-affiliated cardiac catheter labs (ALKK); and a data bank for recording diagnostic cardiac catheterization and PTCA's performed by physicians with private practice (BNK). In 1994, 15% of the diagnostic catheterizations and 16% of the coronary interventions were performed by physicians with private practice. Our survey shows that only 58% of German institutions record the data with a computer, 60% use their own developments; thus, the majority of groups in Germany are not linked to a central data bank. The least requirement for quality assurance should be the recording of major and minor complications as well as a comparison of one's own data with those of a central data bank.

[The technetium-99-m-pyrophosphate scintigram in the assessment of the size of acute myocardial infarction: comparison with CK-(MB) curves mortality (author's transl)]. / Grössenbestimmung akuter Myokardinfarkte mit Technetium-99m-Pyrophosphat. Vergleich zu CK(MC)-Verlauf und Letalität.

While the technetium-99m-pyrophosphate scintigram enables diagnostic proof of acute myocardial infarction, its use in the evaluation of the extent of infarction has not been clearly established. This study, in 30 patients with acute myocardial infarction was, thus, undertaken to assess the relationship between the findings of the technetium-99m-pyrophosphate scintigram, with respect to infarct area and uptake pattern, the infarct size, as determined from the total CK an CK-MB curves, and the mortality. The scintigraphically determined infarct areas ranged between 1.7 and 29.3 cm2; the 20.2 plus or minus 6.0 cm2 average for anterior wall infarction (n=18, range 7.4 to 29.3 cm2) was significantly greater (p smaller than 0.005) than the 8.3 plus or minus 5.3 cm2 average for inferior infarction (n=12, range 1.7 to 15.8 cm2). Correlation coefficients between the scintigraphically and enzymatically determined infarct sizes for the entire patient population ranged from 0.71 to 0.80. Anterior infarctions correlated more closely (0.66 to 0.84) than inferior infarctions (0.46 to 0.66). The technetium-99m-pyrophosphate uptake pattern was focal in 20 patients and ring-shaped (doughnut) in ten. Infarcts with focal uptake patterns were significantly smaller than those displaying a doughnut pattern (12.2 plus or minus 6.4 vs. 24 plus or minus 4.0 cm2, p smaller than 0.005). The infarct weight calculated from the CK-MC curve with application of individually determined disappearance rate for those infarcts displaying a focal uptake pattern was 34 plus or minus 29 grams while that associated with a doughnut uptake pattern was significantly greater at 86 plus or minus 25 grams (p smaller than 0.005). During the 18 -month observation period there were six deaths; the average scintigraphic infarct area of 22.8 plus or minus 3.6 cm2 in those who died was significantly greater (p smaller than 0.005) than that of the 13.8 plus or minus 8.2 cm2 of the survivors. Of the non-survivors, five had a doughnut uptake pattern and one displayed focal uptake. In the 24 survivors, a focal uptake pattern was found in 19 and a doughnut pattern in five. Conversely, 19 of the 20 patients with a focal uptake pattern survived while only five of the ten patients with a doughnut pattern were alive after 18 months. Thus, comparison with the enzymatically determined infarct weight as well as the mortality indicate that the technetium-99m-pyrophosphate scintigram yields clinically relevant data with regard to infarct size. Since no patient with an infarct area of less than 17 cm2 died within the 18-month observation period, designation of scintigraphically determined infarct size as small (smaller than 17 cm2) and large (larger than 17 cm2) was enabled. The corresponding cut-off point between large and small infarctions as determined enzymatically has been designated at 65 grams. Accordingly, agreement was found in 70% (14 of 20 patients) with scintigraphically small infarcts and in 80% (8 of 10 patients) with scintigraphically large infarcts...