A review of cost-effectiveness analysis: From theory to clinical practice.

Cost-effectiveness analysis has long been practiced; registries date back to the United States of America War Department in 1886. In addition, everyone does intuitive cost-effectiveness analyses in their daily lives. In routine medical care, health economic assessment becomes increasingly important due to progressively limited resources, rising demands, population increases, and continuous therapeutic innovations. The health economic assessment must analyze the outcomes and costs of actions and technologies as objectively as possible to guarantee efficient assessment of novel interventions for Public Health Policy. In other words, it is necessary to determine how much society or patients are willing to or able to pay for novel interventions compared with existing alternatives, given the available resources. In addition, increased cost may displace other health care services already provided in case of fixed budget health care systems. To conduct such analyses, researchers must use standard methodologies and interpretations in light of regional characteristics according to social and economic determinants as well as clinical practice. Such an approach may be essential for transforming the current healthcare system to a value-based model. In this narrative review, concepts of the importance of and some approaches to health economic evaluation in clinical practice will be discussed.

Better outcome at lower costs after implementing a CRT-care pathway: comprehensive evaluation of real-world data.

AIMS: Cardiac resynchronization therapy (CRT) requires intensive, complex, and multidisciplinary care for heart failure (HF) patients. Due to limitations in time, resources, and coordination of care, in current practice, this is often incomplete. We evaluated the effect of the introduction of a CRT-care pathway (CRT-CPW) on clinical outcome and costs. METHODS AND RESULTS: The CRT-CPW focused on structuring CRT patient selection, implantation, and follow-up management. To facilitate and guarantee quality, checklists were introduced. The CRT-CPW was implemented in the Maastricht University Medical Centre in 2014. Physician-led usual care was restructured to a nurse-led care pathway. A retrospective comparison of data from CRT patients receiving usual care (2012-2014, 222 patients) and patients receiving care according to CRT-CPW (2015-2018, 241 patients) was performed. The primary outcome was the composite of all-cause mortality and HF hospitalization. Hospital-related costs of cardiovascular care after CRT implantation were analysed to address cost-effectiveness of the CRT-CPW. Demographics were comparable in the usual care and CRT-CPW groups. Kaplan-Meier estimates of the occurrence of the primary endpoint showed a significant improvement in the CRT-CPW group (25.7% vs. 34.7%, hazard ratio 0.56; confidence interval 0.40-0.78; P < 0.005), at 36 months of follow-up. The total costs for cardiology-related hospitalizations were significantly reduced in the CRT-CPW group [€17 698 (14 192-21 195) vs. 19 933 (16 980-22 991), P < 0.001]. Bootstrap cost-effectiveness analyses showed that implementation of CRT-CPW would be an economically dominant strategy in 90.7% of bootstrap samples. CONCLUSIONS: The introduction of a novel multidisciplinary, nurse-led care pathway for CRT patients resulted in significant reduction of the combination of all-cause mortality and HF hospitalizations, at reduced cardiovascular-related hospital costs.

The combination of carboxy-terminal propeptide of procollagen type I blood levels and late gadolinium enhancement at cardiac magnetic resonance provides additional prognostic information in idiopathic dilated cardiomyopathy - A multilevel assessment of myocardial fibrosis in dilated cardiomyopathy.

AIMS: To determine the prognostic value of multilevel assessment of fibrosis in dilated cardiomyopathy (DCM) patients. METHODS AND RESULTS: We quantified fibrosis in 209 DCM patients at three levels: (i) non-invasive late gadolinium enhancement (LGE) at cardiac magnetic resonance (CMR); (ii) blood biomarkers [amino-terminal propeptide of procollagen type III (PIIINP) and carboxy-terminal propeptide of procollagen type I (PICP)], (iii) invasive endomyocardial biopsy (EMB) (collagen volume fraction, CVF). Both LGE and elevated blood PICP levels, but neither PIIINP nor CVF predicted a worse outcome defined as death, heart transplantation, heart failure hospitalization, or life-threatening arrhythmias, after adjusting for known clinical predictors [adjusted hazard ratios: LGE 3.54, 95% confidence interval (CI) 1.90-6.60; P < 0.001 and PICP 1.02, 95% CI 1.01-1.03; P = 0.001]. The combination of LGE and PICP provided the highest prognostic benefit in prediction (likelihood ratio test P = 0.007) and reclassification (net reclassification index: 0.28, P = 0.02; and integrated discrimination improvement index: 0.139, P = 0.01) when added to the clinical prediction model. Moreover, patients with a combination of LGE and elevated PICP (LGE+/PICP+) had the worst prognosis (log-rank P < 0.001). RNA-sequencing and gene enrichment analysis of EMB showed an increased expression of pro-fibrotic and pro-inflammatory pathways in patients with high levels of fibrosis (LGE+/PICP+) compared to patients with low levels of fibrosis (LGE-/PICP-). This would suggest the validity of myocardial fibrosis detection by LGE and PICP, as the subsequent generated fibrotic risk profiles are associated with distinct cardiac transcriptomic profiles. CONCLUSION: The combination of myocardial fibrosis at CMR and circulating PICP levels provides additive prognostic value accompanied by a pro-fibrotic and pro-inflammatory transcriptomic profile in DCM patients with LGE and elevated PICP.

Soluble CD146-an underreported novel biomarker of congestion: a comment on a review concerning congestion assessment and evaluation in acute heart failure.

In spite of high prevalence, congestion remains a poorly understood phenomenon in heart failure pathophysiology. Its negative impact on outcome has been widely recognised. Still, data from various registries reveal the failure of the contemporary treatment strategies to overcome congestion. This shortcoming is closely related to the fact that there are no universe means for congestion assessment and grading, making it a difficult process to recognise. CD146 is a novel blood biomarker of congestion that has been shown to reflect intravascular fluid accumulation in a number of experimental and clinical studies. This observation deserves special attention, given the huge gap of knowledge about decongestive strategies in acute and chronic heart failure. Randomised clinical trials testing the effect of CD146-guided management intervention are urgently needed to estimate its value in heart failure care.

Reasons for readmission after hospital discharge in patients with chronic diseases-Information from an international dataset.

BACKGROUND: Chronic diseases are increasingly prevalent in Western countries. Once hospitalised, the chance for another hospitalisation increases sharply with large impact on well-being of patients and costs. The pattern of readmissions is very complex, but poorly understood for multiple chronic diseases. METHODS: This cohort study of administrative discharge data between 2009-2014 from 21 tertiary hospitals (eight USA, five UK, four Australia, four continental Europe) investigated rates and reasons of readmissions to the same hospital within 30 days after unplanned admission with one of the following chronic conditions; heart failure; atrial fibrillation; myocardial infarction; hypertension; stroke; chronic obstructive pulmonary disease (COPD); bacterial pneumonia; diabetes mellitus; chronic renal disease; anaemia; arthritis and other cardiovascular disease. Proportions of readmissions with similar versus different diseases were analysed. RESULTS: Of 4,901,584 admissions, 866,502 (17.7%) were due to the 12 chronic conditions. In-hospital, 43,573 (5.0%) patients died, leaving 822,929 for readmission analysis. Of those, 87,452 (10.6%) had an emergency 30-day readmission, rates ranged from 2.8% for arthritis to 18.4% for COPD. One third were readmitted with the same condition, ranging from 53% for anaemia to 11% for arthritis. Reasons for readmission were due to another chronic condition in 10% to 35% of the cases, leaving 30% to 70% due to reasons other than the original 12 conditions (most commonly, treatment related complications and infections). The chance of being readmitted with the same cause was lower in the USA, for female patients, with increasing age, more co-morbidities, during study period and with longer initial length of stay. CONCLUSION: Readmission in chronic conditions is very common and often caused by diseases other than the index hospitalisation. Interventions to reduce readmissions should therefore focus not only on the primary condition but on a holistic consideration of all the patient's comorbidities.

Is the clinical presentation of chronic heart failure different in elderly versus younger patients and those with preserved versus reduced ejection fraction?

BACKGROUND: Whether the clinical presentation and in particular prevalence of symptoms and signs of heart failure (HF) is different in elderly versus younger patients and in those with reduced (HFrEF) versus preserved (HFpEF) left ventricular ejection fraction (LVEF) is a matter of ongoing debate. AIMS: To compare detailed clinical characteristics of these important subgroups and to develop a prediction rule for the differentiation of HFpEF and HFrEF based on clinical parameters. METHODS: The analysis was based on the Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure (TIME-CHF) comprising 622 patients ≥60 years with HF including the whole LVEF spectrum. RESULTS: In the groups ≥75 years and with HFpEF typical symptoms and clinical signs of HF were more prevalent as compared to those <75 years or with HFrEF, respectively. The burden of comorbidities was higher in the older age group. HFrEF could not be differentiated from HFpEF by symptom history and clinical examination alone. However, a combination of age, presence of pulmonary rales, systolic blood pressure, cause of heart failure, osteoporosis, current smoking, NT-proBNP, haemoglobin, QRS width and heart rhythm allowed to identify HFrEF versus HFpEF with a sensitivity of 81% and specificity of 90% (c-statistics 0.91). CONCLUSIONS: More symptoms and signs of HF were present both in the older age group and in patients with HFpEF. HFpEF versus HFrEF could be differentiated by a set of simple clinical, laboratory and ECG parameters but not by symptom history and physical examination alone.

Cost-Effectiveness Benefits of a Disease Management Program:The REMADHE Trial Results.

BACKGROUND: Published studies have generated mixed, controversial results regarding the cost-effectiveness of heart failure disease management programs (HF-DMPs). This study assessed the cost-effectiveness of an HF-DMP in ambulatory patients compared with usual care (UC). METHODS: In the prospective randomized REMADHE trial, we evaluated incremental costs per quality-adjusted life-year (QALY) and life-year (LY) gained as effectiveness ratios (ICERs) over a study period of 2.47 ± 1.75 years. RESULTS: The REMADHE HF-DMP was more effective and less costly than UC in terms of both QALYs and LYs (95% and 55% chance of dominance, respectively). Average saving was US$7345 (2.5%-97.5% bootstrapped confidence interval -16,573 to +921). The chance of DMP being cost-effective at a willingness to pay US$10,000 per QALY or LY was 99% and 96%, respectively. Cost-effectiveness of HF-DMP was highest in subgroups with left ventricular ejection fraction <35%, age >50 years, male sex, New York Heart Association (NYHA) functional class ≥III, and ischemic etiology. The chance of DMP being cost-effective at a willingness to pay US$10,000 per QALY was ≥90% in all subgroups apart from NYHA functional class I-II, where it was 70%. Even when the intervention costs increased by 500% or when excluding outliers in costs, DMP had a high chance of being cost-effective (87%-99%). CONCLUSIONS: The HF-DMP of the REMADHE trial, which encompasses long-term repeated education alongside telephone monitoring, has a high probability of being cost-effective in ambulatory patients with HF.

Heart failure in nursing home residents; a cross-sectional study to determine the prevalence and clinical characteristics.

BACKGROUND: Heart failure (HF) is expected to be highly prevalent in nursing home residents, but precise figures are scarce. The aim of this study was to determine the prevalence of HF in nursing home residents and to get insight in the clinical characteristics of residents with HF. METHODS: The study followed a multi-centre cross-sectional design. Nursing home residents (n = 501) in the southern part of the Netherlands aged over 65 years and receiving long-term somatic or psychogeriatric care were included in the study. The diagnosis of HF and related characteristics were based on data collected from actual clinical examinations (including history, physical examination, ECG, cardiac markers and echocardiography), patient records and questionnaires. A panel of two cardiologists and a geriatrician ultimately judged the data to diagnose HF. RESULTS: The overall prevalence of HF in nursing home residents was 33 %, of which 52 % had HF with preserved ejection fraction. The symptoms dyspnoea and oedema and a cardiac history were more common in residents with HF. Diabetes mellitus, chronic obstructive pulmonary disease (COPD) were also more prevalent in those with HF. Residents with HF had a higher score on the Mini Mental State Examination. 54 % of those with HF where not known before, and in 31 % with a history of HF, this diagnosis was not confirmed by the expert panel. CONCLUSION: This study shows that HF is highly prevalent in nursing home residents with many unknown or falsely diagnosed with HF. Equal number of HF patients had reduced and preserved left-ventricular ejection fraction. TRIAL REGISTRATION: The Netherlands National Trial Register NTR2663 (27-12-2010).

Long-term effect of a school-based physical activity program (KISS) on fitness and adiposity in children: a cluster-randomized controlled trial.

BACKGROUND: School-based intervention studies promoting a healthy lifestyle have shown favorable immediate health effects. However, there is a striking paucity on long-term follow-ups. The aim of this study was therefore to assess the 3 yr-follow-up of a cluster-randomized controlled school-based physical activity program over nine month with beneficial immediate effects on body fat, aerobic fitness and physical activity. METHODS AND FINDINGS: Initially, 28 classes from 15 elementary schools in Switzerland were grouped into an intervention (16 classes from 9 schools, n = 297 children) and a control arm (12 classes from 6 schools, n = 205 children) after stratification for grade (1st and 5th graders). Three years after the end of the multi-component physical activity program of nine months including daily physical education (i.e. two additional lessons per week on top of three regular lessons), short physical activity breaks during academic lessons, and daily physical activity homework, 289 (58%) participated in the follow-up. Primary outcome measures included body fat (sum of four skinfolds), aerobic fitness (shuttle run test), physical activity (accelerometry), and quality of life (questionnaires). After adjustment for grade, gender, baseline value and clustering within classes, children in the intervention arm compared with controls had a significantly higher average level of aerobic fitness at follow-up (0.373 z-score units [95%-CI: 0.157 to 0.59, p = 0.001] corresponding to a shift from the 50th to the 65th percentile between baseline and follow-up), while the immediate beneficial effects on the other primary outcomes were not sustained. CONCLUSIONS: Apart from aerobic fitness, beneficial effects seen after one year were not maintained when the intervention was stopped. A continuous intervention seems necessary to maintain overall beneficial health effects as reached at the end of the intervention. TRIAL REGISTRATION: ControlledTrials.com ISRCTN15360785.

Cost-effectiveness of N-terminal pro-B-type natriuretic-guided therapy in elderly heart failure patients: results from TIME-CHF (Trial of Intensified versus Standard Medical Therapy in Elderly Patients with Congestive Heart Failure).

OBJECTIVES: This study aimed to assess cost-effectiveness of N-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided versus symptom-guided therapy in heart failure (HF) patients ≥60 years old. BACKGROUND: Cost-effectiveness of NT-proBNP guidance in HF patients is unclear. It may create additional costs with uncertain benefits. METHODS: In the TIME-CHF (Trial of Intensified versus Standard Medical Therapy in Elderly Patients with Congestive Heart Failure), patients with left ventricular ejection fraction (LVEF) of ≤45% were randomized to receive intensified NT-proBNP-guided therapy or standard, symptom-guided therapy. For cost-effectiveness analysis, 467 (94%) patients (age 76 ± 7 years, 66% male) were eligible. Incremental cost-effectiveness was calculated as incremental costs per gained life-year and quality-adjusted life-year (QALY) within the 18-month trial period, as defined per protocol. RESULTS: NT-proBNP-guided therapy was dominant (i.e., more effective and less costly) over symptom-guided therapy, saving $2,979 USD (2.5 to 97.5% confidence interval [CI]: $8,758 to $3,265) per patient, with incremental effectiveness of +0.07 life-years and +0.05 QALYs. The probability of NT-proBNP-guided therapy being dominant was 80%, and the probability of saving 1 life-year or QALY at a cost of $50,000 was 97% and 93%, respectively. Exclusion of residence costs resulted in an incremental cost-effectiveness ratio (ICER) of $5,870 per life-year gained. Cost-effectiveness of NT-proBNP-guided therapy was most pronounced in patients <75 years old and in those with <2 significant comorbidities, being dominant in all sensitivity analyses. In the worst-case scenario (excluding residence costs in those with ≥2 comorbidities), the ICER was $11,935 per life-year gained. CONCLUSIONS: NT-proBNP-guided therapy has a high probability of being cost effective in HF patients with reduced LVEF, particularly in patients age 60 to 75 years or with less than 2 comorbidities. (Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure [TIME-CHF]; ISRCTN43596477).

Multimarker strategy for short-term risk assessment in patients with dyspnea in the emergency department: the MARKED (Multi mARKer Emergency Dyspnea)-risk score.

OBJECTIVES: The study aim was to determine the prognostic value of a multimarker strategy for risk-assessment in patients presenting to the emergency department (ED) with dyspnea. BACKGROUND: Combining biomarkers with different pathophysiological backgrounds may improve risk stratification in dyspneic patients in the ED. METHODS: The study prospectively investigated the prognostic value of the biomarkers N-terminal pro-B-type natriuretic peptide (NT-proBNP), high-sensitivity cardiac troponin T (hs-cTnT), Cystatin-C (Cys-C), high-sensitivity C-reactive protein (hs-CRP), and Galectin-3 (Gal-3) for 90-day mortality in 603 patients presenting to the ED with dyspnea as primary complaint. RESULTS: hs-CRP, hs-cTnT, Cyst-C, and NT-proBNP were independent predictors of 90-day mortality. The number of elevated biomarkers was highly associated with outcome (odds ratio: 2.94 per biomarker, 95% confidence interval [CI]: 2.29 to 3.78, p < 0.001). A multimarker approach had incremental value beyond a single-marker approach. Our multimarker emergency dyspnea-risk score (MARKED-risk score) incorporating age ≥75 years, systolic blood pressure <110 mm Hg, history of heart failure, dyspnea New York Heart Association functional class IV, hs-cTnT ≥0.04 µg/l, hs-CRP ≥25 mg/l, and Cys-C ≥1.125 mg/l had excellent prognostic performance (area under the curve: 0.85, 95% CI: 0.81 to 0.89), was robust in internal validation analyses and could identify patients with very low (<3 points), intermediate (≥3, <5 points), and high risk (≥5 points) of 90-day mortality (2%, 14%, and 44% respectively; p < 0.001). CONCLUSIONS: A multimarker strategy provided superior risk stratification beyond any single-marker approach. The MARKED-risk score that incorporates hs-cTnT, hs-CRP, and Cys-C along with clinical risk factors accurately identifies patients with very low, intermediate, and high risk.

The prevalence and management of heart failure in Dutch nursing homes; design of a multi-centre cross-sectional study.

BACKGROUND: Heart failure is likely to be particularly prevalent in the nursing home population, but reliable data about the prevalence of heart failure in nursing homes are lacking. Therefore the aims of this study are to investigate (a) the prevalence and management of heart failure in nursing home residents and (b) the relation between heart failure and care dependency as well as heart failure and quality of life in nursing home residents. METHODS/DESIGN: Nursing home residents in the southern part of the Netherlands, aged over 65 years and receiving long-term somatic or psychogeriatric care will be included in the study. A panel of two cardiologists and a geriatrician will diagnose heart failure based on data collected from actual clinical examinations (including history, physical examination, ECG, cardiac markers and echocardiography), patient records and questionnaires. Care dependency will be measured using the Care Dependency Scale. To measure the quality of life of the participating residents, the Qualidem will be used for psychogeriatric residents and the SF-12 and VAS for somatic residents. CONCLUSION: The study will provide an insight into the actual prevalence and management of heart failure in nursing home residents as well as their quality of life and care dependency. TRIAL REGISTRATION: Dutch trial register NTR2663.

Cost-effectiveness of drug-eluting stents in patients at high or low risk of major cardiac events in the Basel Stent KostenEffektivitäts Trial (BASKET): an 18-month analysis.

BACKGROUND: Our aim was to determine whether drug-eluting stents are good value for money in long-term, everyday practice. METHODS: We did an 18-month cost-effectiveness analysis of the Basel Stent KostenEffektivitäts Trial (BASKET), which randomised 826 patients 2:1 to drug-eluting stents (n=545) or to bare-metal stents (281). We used non-parametric bootstrap techniques to determine incremental cost-effectiveness ratios (ICERs) of drug-eluting versus bare-metal stents, to compare low-risk (> or =3.0 mm stents in native vessels; n=558, 68%) and high-risk patients (<3.0 mm stents/bypass graft stenting; n=268, 32%), and to do sensitivity analyses by altering costs and event rates in the whole study sample and in predefined subgroups. Quality-adjusted life-years (QALYs) were assessed by EQ-5D questionnaire (available in 703/826 patients). FINDINGS: Overall costs were higher for patients with drug-eluting stents than in those with bare-metal stents (11,808 euros [SD 400] per patient with drug-eluting stents and 10,450 euros [592] per patient with bare-metal stents, mean difference 1358 euros [717], p<0.0001), due to higher stent costs. We calculated an ICER of 64,732 euros to prevent one major adverse cardiac event, and of 40,467 euros per QALY gained. Stent costs, number of events, and QALYs affected ICERs most, but unrealistic alterations would have been required to achieve acceptable cost-effectiveness. In low-risk patients, the probability of drug-eluting stents achieving an arbitrary ICER of 10,000 euros or less to prevent one major adverse cardiac event was 0.016; by contrast, it was 0.874 in high-risk patients. INTERPRETATION: If used in all patients, drug-eluting stents are not good value for money, even if prices were substantially reduced. Drug-eluting stents are cost effective in patients needing small vessel or bypass graft stenting, but not in those who require large native vessel stenting.

Targeted stent use in clinical practice based on evidence from the Basel Stent Cost Effectiveness Trial (BASKET).

AIM: It is unknown which patients benefit most from drug-eluting stents (DES) against bare-metal stents (BMS) in a long-term clinical outcome. METHODS AND RESULTS: To address this question, data from 826 consecutive patients with angioplasty, randomized 2:1 to DES vs. BMS, with an 18-month follow-up for cardiac death/myocardial infarction (MI) and non-MI-related target-vessel revascularization (TVR) were analysed for interactions between stent type and patient/vessel characteristics predicting events. Rates of 18-month TVRs were lower with DES vs. BMS use (7.5 vs. 11.6%, P = 0.05), but similar for both stents regarding cardiac death/MI (DES, 8.4%; BMS, 7.5%; P = 0.70). Significant interactions between stent type and two multivariable event predictors were identified: small stents (<3.0 mm) and bypass graft stenting. In these patient groups together (n = 268, 32%), DES reduced non-MI-related TVR (HR = 0.44; P = 0.02) and cardiac death/MI (HR = 0.44; P = 0.04), whereas in the other 558 patients (68%) TVR rate was similar (HR = 0.75; P = 0.38) and cardiac death/MI rate increased after DES (HR = 2.07; P = 0.05). CONCLUSION: Patients with angioplasty of small vessels or bypass grafts seem to benefit from DES use, in long-term outcome, in contrast to patients with large native vessel stenting where there might even be late harm. Still, this hypothesis needs to be tested prospectively.

Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitäts Trial (BASKET).

BACKGROUND: No prospective trial-based data are available for incremental cost-effectiveness of drug-eluting stents (DES) compared with bare-metal stents (BMS) in unselected patients, as treated in everyday practice. METHODS: The Basel stent cost-effectiveness trial (BASKET) included 826 consecutive patients treated with angioplasty and stenting for 1281 de-novo lesions, irrespective of indication for angioplasty. Patients were randomised to one of two DES (Cypher, n=264; Taxus, n=281) or to a cobalt-chromium-based BMS (Vision, n=281) and followed up for 6 months for occurrence of major adverse cardiac events and costs. Analysis was by intention-to-treat. The primary endpoint was cost-effectiveness after 6 months, with effectiveness defined as reduction of major adverse cardiac events. FINDINGS: Cardiac death, myocardial infarction, or target vessel revascularisation occurred in 39 of 544 (7.2%) patients with DES and 34 of 280 (12.1%) with BMS (odds ratio 0.56, 95% CI 0.35-0.91; p=0.02), without significant differences between the two DES. Total costs at 6 months were higher with DES (mean 10,544, SD 6849) than with BMS (9639, 9067; p<0.0001); higher stent costs of DES were not compensated for by lower follow-up costs. Incremental cost-effectiveness ratio of DES compared with BMS to avoid one major event was 18,311, and costs per quality-adjusted life-year gained were more than 50 000. Subgroup analyses showed that DES were more cost-effective for elderly patients in specific high-risk groups. INTERPRETATION: In a real-world setting, use of DES in all patients is less cost effective than in studies with selected patients. Use of these stents could be restricted to patients in high-risk groups.

Comparison of costs and safety of a suture-mediated closure device with conventional manual compression after coronary artery interventions.

The aim of this study was to assess costs and safety of immediate femoral sheath removal and closure with a suture-mediated closure device (Perclose, Menlo Park, CA) in patients undergoing elective (PCI). A total of 193 patients was prospectively randomized to immediate arterial sheath removal and access site closure with a suture-mediated closure device (SMC; n = 96) or sheath removal 4 hr after PCI followed by manual compression (MC; n = 97). In the SMC group, patients were ambulated 4 hr after elective PCI if hemostasis was achieved. In the MC group, patients were ambulated the day after the procedure. In addition to safety, total direct costs including physician and nursing time, infrastructure, and the device were assessed in both groups. Total direct costs were significantly (all P < 0.001) lower in the SMC group. Successful hemostasis without major complication was achieved in all patients. The time to achieve hemostasis was significantly shorter in the SMC group (7.1 +/- 3.4 vs. 22.9 +/- 14.0 min; P < 0.01) and 85% of SMC patients were ambulated on the day of intervention. Suture-mediated closure allows a reduction in hospitalization time, leading to significant cost savings due to decreased personnel and infrastructural demands. In addition, the use of SMC is safe and convenient to the patients.

Noninvasive assessment of cardiac pumping capacity during exercise predicts prognosis in patients with congestive heart failure.

BACKGROUND: Prognostic parameters in patients with congestive heart failure (CHF) are important for guiding therapeutic options. Maximal oxygen uptake (O(2)max) is a widely used parameter for prognostic assessment in patients with CHF and correlates with exercise cardiac output; however, afterload is not taken into account. METHODS: The concept of a noninvasive surrogate of cardiac power output combines exercise systolic BP (SBP), as an estimate of afterload, with O(2)max, as an estimate of exercise cardiac output neglecting preload. Thus, a variable termed exercise cardiac power (ECP) is defined as the product of O(2)max (expressed as a percent predicted value) and SBP (ECP, expressed as %mm Hg, is the product of O(2)max, expressed as percentage of predicted maximum, times systolic pressure. The prognostic value of ECP obtained during routine treadmill ergospirometry was assessed in patients referred to our heart failure clinic. Patients undergoing heart transplantation were censored at the time of transplantation. RESULTS: One hundred fifty-four patients were followed prospectively for a mean (+/- SE) duration of 625 +/- 32 days. Thirty-two patients (21%) died. ECP was the most powerful predictor of mortality, was the combined end point of mortality or hospitalization for worsening heart failure (all p < 0.001), and was an independent predictor in multivariate analysis. An ECP of < 5,000 %mm Hg indicated a poor prognosis with a 1-year mortality rate of 37%, whereas only 2% of the patients having an ECP of > 9,000 %mm Hg died during the first year. CONCLUSION: The integration of afterload and O(2)max improves the prognostic value of each indicator, and provides an easily available and independent predictor of mortality and morbidity in CHF patients. This integrative concept of cardiac hydraulic performance is superior to O(2)max and can be used in routine ergospirometry.