Translating 'See-and-Treat' to primary care: opening the gates does not cause a flood.

OBJECTIVE: To explore how the See-and-Treat concept can be applied in primary care and its effect on volume and productivity. DESIGN: An explanatory single-case study design with a mixed methods approach and presented according to the SQUIRE 2.0 guidelines. SETTING: A publicly-funded, private primary care provider within the Stockholm County, which caters to a diverse patient population in terms of ethnicity, religion, socioeconomic status and care needs. PARTICIPANTS: CEO, center manager, four physicians, two licensed practical nurses, one medical secretary and one lab assistant. INTERVENTION: A See-and-Treat unit was established to offer same-day service for acute unplanned visits. Standardized patient symptom forms were created that allowed patients to self-triage and then enter into a streamlined care process consisting of a quick diagnostic lab and a physician visit. MAIN OUTCOME MEASURES: Volume, productivity, staff perceptions and patient satisfaction were measured through data on number and type of contacts per 1000 listed patients, visits per physician, observations, interviews and a questionnaire. RESULTS: A significant decrease in the acute and total number of visits, a continued trend of diminishing telephone contacts, and a non-significant increase in physician productivity. Patients were very satisfied, and staff perceived an improved quality of care. CONCLUSIONS: See-and-Treat appears to be a viable approach for a specific primary care patient segment interested in acute same-day-service. Opening up access and standardizing care made it possible to efficiently address these needs and engage patients.

Cost-utility analysis of percutaneous mitral valve repair in inoperable patients with functional mitral regurgitation in German settings.

BACKGROUND: To determine the cost-effectiveness of the percutaneous mitral valve repair (PMVR) using Carillon® Mitral Contour System® (Cardiac Dimensions Inc., Kirkland, WA, USA) in patients with congestive heart failure accompanied by moderate to severe functional mitral regurgitation (FMR) compared to the prolongation of optimal medical treatment (OMT). METHODS: Cost-utility analysis using a combination of a decision tree and Markov process was performed. The clinical effectiveness was determined based on the results of the Transcatheter Implantation of Carillon Mitral Annuloplasty Device (TITAN) trial. The mean age of the target population was 62 years, 77% of the patients were males, 64% of the patients had severe FMR and all patients had New York Heart Association functional class III. The epidemiological, cost and utility data were derived from the literature. The analysis was performed from the German statutory health insurance perspective over 10-year time horizon. RESULTS: Over 10 years, the total cost was €36,785 in the PMVR arm and €18,944 in the OMT arm. However, PMVR provided additional benefits to patients with an 1.15 incremental quality-adjusted life years (QALY) and an 1.41 incremental life years. The percutaneous procedure was cost-effective in comparison to OMT with an incremental cost-effectiveness ratio of €15,533/QALY. Results were robust in the deterministic sensitivity analysis. In the probabilistic sensitivity analysis with a willingness-to-pay threshold of €35,000/QALY, PMVR had a 84 % probability of being cost-effective. CONCLUSIONS: Percutaneous mitral valve repair may be cost-effective in inoperable patients with FMR due to heart failure.

Thoratec CentriMag for temporary treatment of refractory cardiogenic shock or severe cardiopulmonary insufficiency: a systematic literature review and meta-analysis of observational studies.

The aim of the study was to systematically evaluate effect of CentriMag heart pump (Thoratec Corporation) as temporary ventricular assist device (VAD) and part of extracorporeal membrane oxygenation (ECMO) system on outcomes in patients with cardiac or cardiac-respiratory failure. A systematic search was conducted in five databases for the period 2003 to 2012. Fifty-three publications with data for 999 patients, supported with CentriMag, were included. In 72% studies, CentriMag was used as a VAD and in 25% as part of ECMO circuit. Mean duration of VAD support was 25.0 days in precardiotomy group, 10.9 days in postcardiac surgery cardiogenic shock group, 8.8 days in post-transplant graft failure and rejection group, and 16.0 days in post-LVAD placement right ventricular failure group. Survival on support was 82% (95% CI 70-92) for VAD support in precardiotomy cardiogenic shock indication, 63% (95% CI 46-78) in VAD support in postcardiac surgery cardiogenic shock indication, 62% (95% CI 46-76) in VAD support in post-transplant graft rejection or failure indication, and 83% (95% CI 73-92) in VAD support in post-LVAD placement right ventricular failure indication. CentriMag is an effective technology for temporary support of patients with cardiac and cardiorespiratory failure.

The cost impact of short-term ventricular assist devices and extracorporeal life support systems therapies on the National Health Service in the UK.

OBJECTIVES: The objective of the study was to assess the cost of using different blood pumps for short-term ventricular assist device (VAD) and extracorporeal life support (ECLS) systems for cardiac and cardiorespiratory failure in the UK. METHODS: The cost analysis presented was based on evaluation of the time required to provide circulatory support for the following indications: post-cardiac surgery cardiogenic shock, postacute myocardial infarction cardiogenic shock, deteriorating end-stage heart failure (ESHF) and the ability of different blood pumps to provide support for the necessary duration. The maximum length of support for each device was based on the manufacturers' recommendations. Direct medical cost of each treatment was evaluated only for the period of mechanical circulatory support in adults and children. Only the cost of device, placement and replacement procedures were considered. List prices were used for devices; resource use was based on expert opinion; unit costs were obtained from official UK sources and Wythenshawe hospital, Manchester, UK. Hospital perspective was utilized for analysis. Three VADs were selected for comparison in adults and two in children. Four centrifugal ECLS systems were selected for comparison in adults and two in children. RESULTS: In both VAD and ECLS indications, the CentriMag® was the least expensive when used for support of patients with end-stage heart failure. Compared with Cardiohelp® for ECLS (which has the same maximum claim duration of support of 30 days), CentriMag® lead to cost savings of £4294 per patient in all three clinical conditions considered. In post-cardiac surgery cardiogenic shock, CentriMag® VAD lead to savings of £5014 per patient compared with BPX-80. Results were robust in one-way sensitivity analysis in comparison with Cardiohelp®. CONCLUSIONS: CentriMag® and PediVAS® blood pumps can lead to significant cost savings to the National Health Service, when used instead of other pumps for short-term VAD or ECLS treatment.

Cost-effectiveness of Barostim therapy for the treatment of resistant hypertension in European settings.

OBJECTIVE: The purpose of this study is to simulate the cost-effectiveness and the long-term clinical performance of the Barostim neo System for the treatment of resistant hypertension when compared to optimal medical treatment. METHODS: A decision analytic model with a combination of a decision tree and Markov process was used to evaluate the cost-effectiveness of Barostim. The clinical effectiveness of Barostim was based on the results of the randomized, placebo-controlled Rheos trial and the follow-up substudy of the DEBuT-HT trial. The cost-effectiveness was modelled from a German societal perspective over a lifetime horizon. Patients with high SBP levels have an increased risk of myocardial infarction, stroke, heart failure and end-stage renal disease. RESULTS: In a simulated cohort of 50-year-old patients at high risk of end-organ damage, Barostim therapy generated 1.66 additional life-years and 2.17 additional quality-adjusted life years with an incremental cost of &OV0556;16 891 when compared with continuation of medical management. Barostim was estimated to be cost-effective compared with optimal medical treatment with an incremental cost-effectiveness ratio of &OV0556;7 797/QALY. In the model, Barostim reduced over a lifetime the rates of myocardial infarction by 19%, stroke by 35%, heart failure by 12% and end-stage renal disease by 23%. The cost-effectiveness of Barostim can be greater in younger patients with resistant hypertension and in patients with significant risk factors for end-organ damage. CONCLUSION: Barostim may be a cost-effective treatment when compared with optimal medical management in patients with resistant hypertension.

Systemic inflammation activates the nuclear factor-kappaB regulatory pathway in adipose tissue.

Adipose tissue (AT) is a store of energy but also an endocrine organ with the capacity to produce and release proinflammatory mediators into the circulation. The mechanism that may trigger human AT inflammation on a cellular level still remains largely unknown. The aim of this study was to investigate whether an acute systemic inflammation increases AT inflammatory activity, focused on innate immunity. Open heart surgery results in an extensive acute systemic inflammation. Therefore, we investigated the in vivo gene expression and production of inflammatory mediators in omental and subcutaneous AT stimulated by surgery. Biopsies from omental and subcutaneous AT were collected before and after cardiopulmonary bypass. Blood samples were collected at the same time as the AT biopsies and plasma IL-6 levels were measured with ELISA. RT-PCR was used for quantification of relative AT gene expression. To verify the gene expression results on a protein level, we used immunohistochemistry and microdialysis. After surgery, in both omental and subcutaneous AT, there was a strong upregulation of nuclear factor-kappaB-regulated genes, e.g., chemokine ligand-2, E-selectin, IL-1beta, IL-6, IL-8, and Toll-like receptor-2. Immunohistochemistry showed staining for E-selectin associated with a high number of macrophages in close contact with and in the vascular wall. Increased levels of IL-6 were detected in microdialysate from subcutaneous AT. In conclusion, we present the novel finding that this model of inflammation induced a strong inflammatory response in both omental and subcutaneous AT including adhesion of macrophages to an activated endothelium and release of IL-6 from AT interstitium. It can be hypothesized that AT exerts a modulatory effect on innate immunity in humans.

Quality of life ten years after surgery for acute coronary syndrome or stable angina.

OBJECTIVES: To investigate health-related quality of life (QOL) late after coronary artery bypass grafting (CABG) due to acute coronary syndrome (ACS) or stable angina, and also to compare QOL in these two groups to matched samples from the general Swedish population. DESIGN: One-hundred patients with ACS and 100 with stable angina undergoing CABG were included. A Short Form-36 (SF-36) QOL survey was sent to all patients alive in April, 2008 (n = 142). The primary outcome measures were the SF-36 physical component summary (PCS) and mental component summary (MCS) scores. RESULTS: Response rate was 80%. There was no significant difference in the PCS (39.3 vs. 42.0; p = 0.24) or MCS (47.7 vs. 48.3; p = 0.77) scores between patients with ACS or stable angina after 10.3 years. There was no clinical significant difference in QOL after CABG for ACS or stable angina, and the age- and gender-matched reference population. CONCLUSIONS: Surgical revascularization offers excellent long term QOL, comparable to that of a matched control population. No difference was found between patients with ACS or stable angina pectoris.

Increased rehospitalization rate after coronary bypass operation for acute coronary syndrome: a prospective study in 200 patients.

BACKGROUND: Patients with acute coronary syndrome (ACS) run increased risk of cardiac death or myocardial infarction after coronary artery bypass grafting (CABG). Long-term survival is similar in ACS patients and patients with stable angina pectoris. This study analyzed the cardiac rehospitalization rate up to 10 years after CABG for ACS and stable angina. METHODS: CABG was done in 200 patients, 100 with ACS and 100 with stable angina. Troponin-T levels were assayed and the severity of the unstable symptoms was classified according to Braunwald. Early outcome, long-term survival, and freedom from cardiac rehospitalization were analyzed. RESULTS: Three ACS patients died early and 12 died late. In the control group, there were no early and 19 late deaths. The cumulative long-term survival was 85% for the ACS patients and 81% for the stable patients (p = 0.75). Postoperative myocardial infarction occurred in 5 unstable patients and 1 stable patient (p = 0.01). At 3 years after the operation, freedom from cardiac rehospitalization was significantly higher in the stable patients (9 vs 27, p = 0.001). In the end of the follow-up, there were no differences in the rehospitalization rate. CONCLUSIONS: Similar and excellent long-term survival was found in both ACS and stable patients long-term after CABG. In patients with ACS, variables such as elevated troponin-T and angina at rest herald an increased risk of perioperative myocardial infarction. Freedom from cardiac rehospitalization is significantly higher in stable patients compared with ACS patients during the first postoperative years, indicating recurrent ischemia.

Aprotinin reduces the antiplatelet effect of clopidogrel.

Aprotinin reduces bleeding and transfusion rates in patients undergoing coronary surgery while on clopidogrel. However, safety studies have indicated that aprotinin may have a possible adverse effect related to an increased incidence of thromboembolic events. We therefore studied the adenosinediphosphate (ADP) mediated platelet aggregation before and after administration of aprotinin in patients on clopidogrel. Fifteen clopidogrel-treated patients with acute coronary syndrome undergoing coronary surgery were studied. ADP-mediated platelet aggregation and platelet count ratio (%) were measured before and after a bolus dose [2 x 10(6) kallikrein inhibiting units (KIU)] of aprotinin. Aprotinin induced an increased aggregation in 11 of 15 patients (73%), and a decrease was registered in two patients (13%). The median (25th/75th percentile) ADP-mediated platelet aggregation before and after aprotinin was 84% (76/91) and 94% (86/97, P<0.01). Clopidogrel non-responders with >90% aggregation (n=4) had a median aggregation of 94.5% (91.5/97.5) vs. 82% (73/87, P<0.01) in the responders (n=11). The median increase in platelet aggregation after aprotinin was 8% (5/20) in the responders vs. 0% (-5.25/3, P<0.01) in the non-responders. Aprotinin increased ADP induced platelet aggregation from 84 to 94% in patients on clopidogrel, which corresponds to a median decrease in relative platelet inhibition of >50%.

Comparison of three different chest drainages after coronary artery bypass surgery--a randomised trial in 150 patients.

OBJECTIVE: Drainage of blood from the mediastinum and pleura following open cardiac procedures is usually carried out using one or more large-bore plastic chest tubes. Recently small diameter siliastic drains have been reported to evacuate blood with a better patient comfort. The efficacy and safety of different chest tubes have not yet been fully evaluated. METHODS: One hundred fifty patients undergoing coronary artery bypass surgery were randomised to have either Blake) 24F (Ethicon, Inc, Somerville, NJ), Argyle 32F plastic (Tyco Healthcare, Tullamore, UK) or Jostra 32F silastic (Maquet Cardiopulmonary AG, Hirrlingen, Germany) drains inserted for evacuation of postoperative bleeding. Bleeding rate per hour, total blood loss, patient discomfort during drain removal, residual pleural fluid at chest X-ray 3 days and 3 weeks after the operation were recorded. RESULTS: Bleeding pattern and total bleeding did not differ significantly in the three groups. Median blood loss was 615 ml (quartile range 390-820 ml) in the Blake-group, 750 ml (quartile range 430-870 ml) in the Jostra-group and 580 ml (quartile range 450-750 ml) in the Argyle-group, respectively (p=0.17). Pain at removal the day after the operation was similar in the three groups. Residual fluid in the left pleura did not differ significantly at 3 days (p=0.41) or at 3 weeks postoperatively (p=0.42). CONCLUSIONS: None of the three chest tubes was superior to drain postoperative bleeding or considering pain at removal. Local clinical routines and cost aspects should be the guide in choosing drainage system for open cardiac operations.

Plasma levels and vascular effects of endothelin and big endothelin in patients with stable and unstable angina pectoris undergoing coronary bypass grafting.

OBJECTIVES: The aim of this study was to determine the plasma and pericardial levels of endothelin-1 (ET-1) and its precursor big endothelin-1 (Big ET-1) in patients with unstable and stable angina prior to and following coronary bypass surgery. To further investigate the content of ET-1, tissue levels were studied in the internal mammary artery (IMA) in patients with stable and unstable angina pectoris. Finally, the difference in reactivity of the IMA to ET-1 and Big ET-1 in stable and unstable patients was evaluated. METHODS: Plasma and pericardial levels of ET-1 and Big ET-1 were determined with radioimmunoassay in 81 patients (33 unstable) immediately before coronary bypass surgery, and at 6, 14, 40 and 64 h following the procedure. Specimens of the distal IMA from 12 patients (six unstable) were collected at the beginning of surgery for determination of tissue levels of ET-1. Additionally, distal internal mammary arteries were obtained from another 24 patients (12 unstable). These vessels were mounted in organ baths for functional studies on vascular reactivity to ET-1 and Big ET-1. RESULTS: The peripheral plasma levels of ET-1 in unstable patients were significantly lower in patients with unstable angina compared with patients with stable angina pectoris at all points of measurement. The levels of Big ET-1 were significantly higher pre-operatively in the unstable group, but decreased to similar levels to those of stable patients following coronary bypass grafting. There was no difference in ET-1 tissue content in the IMA between the patients. ET-1 and Big ET-1 caused an endothelin(A) (ET(A))-receptor blocker sensitive, concentration-dependent contraction of the IMA obtained from stable as well as unstable patients. CONCLUSIONS: It is concluded that unstable angina pectoris is associated with an increased ET-1 turnover. This increased turnover may participate in the local regulation of coronary vascular tone with subsequent influence of the condition of the patients. The present investigation also implies that ET(A)-blockade may be useful as an additional pharmacological principal in the treatment of unstable angina pectoris prior to revascularization, as well as to prevent post-operative arterial graft spasm.