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Simple Summary: Prostate cancer (PCa) nodal staging does not account for tumor burden within the lymph nodes (LNs). In this retrospective single institution/single surgeon study, we assessed the significance of LN tumor burden in pN1 PCa patients after undergoing robotic-assisted radical prostatectomy with extended pelvic lymph node dissection. Consistent with prior reports, LN tumor burden was found to be significantly associated with biochemical recurrence-free survival (BRFS). This study was the first to report on the significance of the anatomical location of tumor deposits within the LN, as well as the quantified extent of extranodal extension (ENE). Likely due to sample size, the anatomical location within the LN and ENE did not show significant association with BRFS. We emphasize that PCa nodal staging and/or post-operative clinical nomograms should account for LN tumor burden. Background: Prostate cancer (PCa) nodal staging does not account for lymph node (LN) tumor burden. The LN anatomical compartment involved with the tumor or the quantified extent of extranodal extension (ENE) have not yet been studied in relation to biochemical recurrence-free survival (BRFS). Methods: Histopathological slides of 66 pN1 PCa patients who underwent extended pelvic lymph node dissection were reviewed. We recorded metrics to quantify LN tumor burden. We also characterized the LN anatomical compartments involved and quantified the extent of ENE. Results: The median follow-up time was 38 months. The median number of total LNs obtained per patient was 30 (IQR 23–37). In the risk-adjusted cox regression model, the following variables were associated with BRFS: mean size of the largest LN deposit per patient (log2: adjusted hazard ratio (aHR) = 1.91, p < 0.001), the mean total span of all LN deposits per patient (2.07, p < 0.001), and the mean percent surface area of the LN involved with the tumor (1.58, p < 0.001). There was no significant BRFS association for the LN anatomical compartment or the quantified extent of ENE. Conclusion: LN tumor burden is associated with BRFS. The LN anatomical compartments and the quantified extent of ENE did not show significant association with BRFS. [ABSTRACT FROM AUTHOR]

Objective: Although the results of aortic valve replacement with different valve prostheses are well documented in terms of survival, the risks of (valve-related) events are less well explored. Methods: We used a dataset of 3934 patients who underwent aortic valve replacement with either a bioprosthesis (73%) or a mechanical prosthesis (27%) between 1982 and 2003 to simulate the outcome of patients after aortic valve replacement with either valve type. With the use of microsimulation, we compared total age and gender-specific life expectancy, event-free life expectancy, reoperation-free life expectancy, lifetime risks of reoperation, and valve-related events for both valve types. Results: The total follow-up was 26,467 patient-years. The mean follow-up was 6.1 years in the biological arm and 8.5 years in the mechanical arm. The mean age at implantation was 70 and 58 years for biological and mechanical prostheses, respectively, and the percentage of concomitant coronary artery bypass grafting was 47% and 28%, respectively. For a 60-year-old man, simulated life expectancy in years for biological versus mechanical prostheses was 11.9 versus 12.2, event-free life expectancy was 9.8 versus 9.3, and reoperation-free life expectancy was 10.5 versus 11.9. Lifetime risk of reoperation was 25% versus 3%. Lifetime risk of bleeding was 12% versus 41%. Conclusion: Even for patients aged 60 years, event-free life expectancy is better with a bioprosthesis. Although the chance of reoperation is higher, the lifetime risk of bleeding is lower compared with a mechanical prosthesis. Comparing lifetime event risks between different types of valve prostheses provides more insight into patient outcome after aortic valve replacement and aids patient selection and counseling. [Copyright &y& Elsevier]

Objectives: This study was conducted to determine why heart teams recommended transcatheter aortic valve replacement (TAVR) versus surgical AVR (SAVR) for patients at low predicted risk of mortality (PROM) and describe outcomes of these cases.Background: Historically, referral to TAVR was based predominately on the Society of Thoracic Surgeons (STS) risk model's PROM >3%. In selected cases, heart teams had latitude to overrule these scores. The clinical reasons and outcomes for these cases are unclear.Methods: Retrospective data were gathered for all TAVR and SAVR cases conducted by 9 hospitals between 2013 and 2017.Results: Cases included TAVR patients with STS PROM >3% (n = 2,711) and ≤3% (n = 415) and SAVR with STS PROM ≤3% (n = 1,438). Leading reasons for recommending TAVR in the PROM ≤3% group were frailty (57%), hostile chest (22%), severe lung disease (16%), and morbid obesity (13%), and 44% of cases had multiple reasons. Most postoperative and 30-day outcomes were similar between TAVR groups, but the STS PROM ≤3% group had a one-day shorter length of stay (2.5 ± 3.4 vs. 3.5 ± 4.7 days; p ≤ 0.001) and higher one-year survival (91.6% vs. 86.0%, p=0.002). In patients with STS PROM ≤3%, 30-day mortality was higher for TAVR versus SAVR (2.0% vs. 0.6%; p < 0.001).Conclusions: Heart teams recommended TAVR in patients with STS PROM ≤3% primarily due to frailty, hostile chest, severe lung disease, and/or morbid obesity. Similar postoperative outcomes between these patients and those with STS PROM >3% suggest that decisions to overrule STS PROM ≤3% were merited and may have reduced SAVR 30-day mortality rate. [ABSTRACT FROM AUTHOR]

Background The impact of remdesivir (RDV) on mortality rates in coronavirus disease 2019 (COVID-19) is controversial, and the mortality effect in subgroups of baseline disease severity has been incompletely explored. The purpose of this study was to assess the association of RDV with mortality rates in patients with COVID-19. Methods In this retrospective cohort study we compared persons receiving RDV with those receiving best supportive care (BSC). Patients hospitalized between 28 February and 28 May 2020 with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection were included with the development of COVID-19 pneumonia on chest radiography and hypoxia requiring supplemental oxygen or oxygen saturation ≤94% with room air. The primary outcome was overall survival, assessed with time-dependent Cox proportional hazards regression and multivariable adjustment, including calendar time, baseline patient characteristics, corticosteroid use, and random effects for hospital. Results A total of 1138 patients were enrolled, including 286 who received RDV and 852 treated with BSC, 400 of whom received hydroxychloroquine. Corticosteroids were used in 20.4% of the cohort (12.6% in RDV and 23% in BSC). Comparing persons receiving RDV with those receiving BSC, the hazard ratio (95% confidence interval) for death was 0.46 (.31–.69) in the univariate model (P <.001) and 0.60 (.40–.90) in the risk-adjusted model (P =.01). In the subgroup of persons with baseline use of low-flow oxygen, the hazard ratio (95% confidence interval) for death in RDV compared with BSC was 0.63 (.39–1.00; P =.049). Conclusion Treatment with RDV was associated with lower mortality rates than BSC. These findings remain the same in the subgroup with baseline use of low-flow oxygen. [ABSTRACT FROM AUTHOR]

Objectives: This study compares the long-term performance of the Carpentier-Edwards (CE) porcine bioprosthesis and the CE pericardial bioprosthesis for aortic valve replacement (AVR).Background: With new bioprostheses on the horizon, there is renewed interest in how the long-term durability of current pericardial bioprostheses compares with the traditional porcine bioprosthesis.Methods: We reviewed 518 AVR with CE porcine valves from 1974 to 1996 and 1,021 AVR with CE pericardial valves from 1991 to 2002. The age distribution and clinical profiles were similar for both groups. The total (mean) follow-up was 3,322 (6.4) years for porcine and 2,556 (2.5) years for pericardial.Results: Long-term mortality was similar (p = 0.29) for porcine and pericardial, with 10-year survival rates of 34 ± 2% and 38 ± 6%, respectively. Ten-year freedom from major adverse cardiac events was also similar for both (respectively): thromboembolism (80 ± 2% and 87 ± 2%; p = 0.24); endocarditis (98 ± 1% and 99 ± 1%; p = 0.30). However, 10-year freedom from explant was lower for porcine (90 ± 2%) than for pericardial (97 ± 1%, p = 0.04). Reasons for explant for porcine were structural valve deterioration (SVD) (n = 25), endocarditis (n = 4), and periprosthetic leak (n = 2). The reasons for explant for pericardial were SVD (n = 4), endocarditis (n = 4) and periprosthetic leak (n = 1).Conclusions: The current CE pericardial valve offers better midterm durability than the traditional CE porcine valve. Its freedom from SVD and reoperation makes it our current bioprosthesis of choice for AVR in appropriately selected patients. [Copyright &y& Elsevier]

Background: In 2016, the National Comprehensive Cancer Network included neoadjuvant chemotherapy as a treatment option for patients with clinical T4b colon cancer. However, there is little published data on the survival impact of neoadjuvant chemotherapy for locally advanced colon cancer.Methods: Adult patients with non-metastatic clinically staged T3 or T4 colon cancer who underwent surgical resection were identified from the National Cancer Data Base between 2006 and 2014. Treatment was categorized as neoadjuvant chemotherapy followed by surgery and surgery followed by adjuvant chemotherapy. Overall survival was compared between the two groups using propensity score matching.Results: Of 27,575 patients that met inclusion criteria, 26,654 (97%) were treated with surgery followed by adjuvant chemotherapy and 921 (3%) received neoadjuvant chemotherapy followed by surgery. After propensity score matching, patients with T4b colon cancer treated with neoadjuvant chemotherapy had a 23% lower risk of death at 3 years compared to patients that had adjuvant chemotherapy (HR 0.77, 95% CI 0.60-0.98; p = 0.04). However, neoadjuvant chemotherapy did not demonstrate a similar significant benefit for patients with T3 and T4a disease.Conclusions: Patients with clinical T4b colon cancer treated with neoadjuvant chemotherapy may have an improved survival compared to those who receive adjuvant chemotherapy. Further prospective investigation is warranted. [ABSTRACT FROM AUTHOR]

Abstract: Objective: We evaluated video-assisted thoracic surgery (VATS) and open (OPEN) lobectomy for lung cancer and impact upon 6-month postoperative (postop) functional health status and quality of life. Methods: In this retrospective analysis of prospective, observational data, anatomic lobectomy with staging thoracic lymphadenectomy was performed with curative intent for lung cancer. OPEN consisted of either thoracotomy (TH) or median sternotomy (MS). Technique was selected on the basis of anatomic imperative (OPEN: larger or central; VATS smaller or peripheral tumours) and/or surgical skills (VATS lobectomy initiated in 2001). All patients completed the Short Form 36 Health Survey (SF36) and Ferrans and Powers quality-of-life index (QLI) preoperatively (preop) and 6 months postop. Results: A total of 241 patients underwent lobectomy (OPEN, 192; VATS, 49). OPEN included MS 128 and TH 64. Comparison of MS and TH patient demographics, co-morbidities, pulmonary variables, intra-operative variables, stage and cell type, postop complications and 6-month clinical outcomes found no differences, allowing grouping together into OPEN. The VATS group had better pulmonary function testing (PFT), more adenocarcinoma and lower stage. The VATS and OPEN groups did not differ regarding operating time, postop complications and operative or 6-month mortality. The VATS group had less blood loss, transfusion, intra-operative fluid administration and shorter length of stay. Comparing within each group''s preop to 6-month postop data, VATS patients were either the same or better in all SF36 categories (physical functioning, role functioning – physical, role functioning – emotional, social functioning, bodily pain, mental health, energy and general health). The OPEN group, however, was significantly worse in SF36 categories physical functioning, role functioning – physical and social functioning. The preop and 6 months postop VATS versus OPEN QLI scores were not different. At 6 months postop, hospital re-admission and use of pain medication was less in the VATS group. In addition, the VATS group had better preservation of preop performance status. Conclusions: VATS lobectomy for curative lung cancer resection appears to provide a superior functional health recovery compared with OPEN techniques. [Copyright &y& Elsevier]

Abstract: Objective: This study aimed at calculating and comparing the long-term outcomes of patients after aortic valve replacement with the Carpentier-Edwards bovine pericardial and porcine supraannular bioprostheses using microsimulation. Methods: We conducted a meta-analysis of eight studies on the Carpentier-Edwards pericardial valves (2685 patients, 12,250 patient-years) and five studies on the supraannular valves (3796 patients, 20,127 patient-years) to estimate the occurrence rates of valve-related events. Eighteen-year follow-up data sets were used to construct age-dependent Weibull curves that described their structural valvular deterioration. The estimates were entered into a microsimulation model, which was used to calculate the outcomes of patients after aortic valve replacement. Results: The annual hazard rates for thrombo-embolism after aortic valve replacement were 1.35% and 1.76% for the pericardial and supraannular valves, respectively. For a 65-year-old male, median time to structural valvular deterioration was 20.1 and 22.2 years while the lifetime risk of reoperation due to structural valvular deterioration was 18.3% and 14.0%, respectively. The life expectancy of the patient was 10.8 and 10.9 years and event-free life expectancy 9.0 and 8.8 years, respectively. Conclusions: The microsimulation methodology provides insight into the prognosis of a patient after aortic valve replacement with any given valve type. Both the Carpentier-Edwards pericardial and supraannular valve types perform satisfactorily, especially in elderly patients, and show no appreciable difference in long-term outcomes when implanted in the aortic position. [Copyright &y& Elsevier]

Background: Despite the favorable prognosis of AJCC stage I/II melanoma patients, up to 20%-30% will develop metastases. Our objective is to predict long-term risk (probability) of recurrence in early-stage melanoma patients., Methods: A Risk Score to predict long-term recurrence was developed using Cox regression based on 2668 patients. Five clinicopathological risk factors were included. The association of the Risk Score with the risk of recurrence was evaluated using parametric models (exponential, Weibull, and Gompertz models) and compared to the Cox model using the Akaike information criterion. The discrimination of the model was measured by time-dependent ROC analyses. A calibration curve was used to evaluate the agreement between predicted and observed recurrence probabilities., Results: The bootstrap adjusted C-index was 0.76 (95% CI, 0.74-0.79) overall and 0.87 (0.83-0.90) and 0.82 (0.78-0.85) at one and two years, respectively, and then remained above 0.70 up to 20 years. The Gompertz model for prediction of survival from the Risk Score showed the best performance and displayed good agreement with the Kaplan-Meier curves. The calibration curve of the Gompertz model showed a good agreement between predicted and observed 2-, 5-, and 10-year risk of recurrence. Population-level analysis demonstrated a significant association of Risk Score with risk of recurrence, with 10-year risks of recurrence of 4.5%, 13.0%, and 33.7% in the first, second, and third tertiles, respectively., Conclusion: We developed a Risk Score to predict long-term risk of recurrence for early-stage melanoma patients. A Gompertz survival model fit to the Risk Score allows for individualized prediction of time-dependent recurrence risk., (© 2024 The Author(s). Cancer Medicine published by John Wiley & Sons Ltd.)

Overlap weighting, using weights defined as the probability of receiving the opposite treatment, is a relatively new, alternative propensity score-based weighting technique used to adjust for confounding when estimating causal treatment effects. It has preferable properties compared to inverse probability of treatment weighting, such as exact covariate balance, safeguards against extreme weights and emphasis on medical equipoise, where treatment decisions are most uncertain. In this article, we introduce the overlap weighting methodology, compare it to inverse probability of treatment weighting and provide some strategies for assessing weighting impact, through an applied example of hospital mortality. When the propensity score distributions have large separation, inverse probability of treatment weighting has been shown to produce biased and less efficient estimates of the treatment effect, making overlap weighting a preferred method in such cases., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: The Pneumonia Score Index (PSI) was developed to estimate the risk of dying within 30 days of presentation for community-acquired pneumonia patients and is a strong predictor of 30-day mortality after COVID-19. However, three of its required 20 variables (skilled nursing home, altered mental status and pleural effusion) are not discreetly available in the electronic medical record (EMR), resulting in manual chart review for these 3 factors. The goal of this study is to compare a simplified 17-factor version (PSI-17) to the original (denoted PSI-20) in terms of prediction of 30-day mortality in COVID-19., Methods: In this retrospective cohort study, the hospitalized patients with confirmed SARS-CoV-2 infection between 2/28/20-5/28/20 were identified to compare the predictive performance between PSI-17 and PSI-20. Correlation was assessed between PSI-17 and PSI-20, and logistic regressions were performed for 30-day mortality. The predictive abilities were compared by discrimination, calibration, and overall performance., Results: Based on 1,138 COVID-19 patients, the correlation between PSI-17 and PSI-20 was 0.95. Univariate logistic regression showed that PSI-17 had performance similar to PSI-20, based on AUC, ICI and Brier Score. After adjusting for confounding variables by multivariable logistic regression, PSI-17 and PSI-20 had AUCs (95% CI) of 0.85 (0.83-0.88) and 0.86 (0.84-0.89), respectively, indicating no significant difference in AUC at significance level of 0.05., Conclusion: PSI-17 and PSI-20 are equally effective predictors of 30-day mortality in terms of several performance metrics. PSI-17 can be obtained without the manual chart review, which allows for automated risk calculations within an EMR. PSI-17 can be easily obtained and may be a comparable alternative to PSI-20., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: G.A.D reported receipt of clinical trial research support from Gilead Sciences, Regeneron, Roche, Boehringer Ingelheim, Edesa Biotech and NeuroBo Pharmaceuticals. J.D.G reports contracted research from Helix, Gilead, Eli Lilly, and Regeneron, grants from Merck (BARDA) and Gilead, and collaborative services agreements with Adaptive Biotechnologies, Monogram Biosciences and Labcorp; and serving as a consultant, speaker or advisory board member for Gilead, and Eli Lilly. All other authors have nothing to disclose., (Copyright: © 2024 Chang et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: High-volume centers (HVC), academic centers (AC), and longer travel distances (TD) have been associated with improved outcomes for patients undergoing surgery for pancreatic adenocarcinoma (PAC). Effects of mediating variables on these associations remain undefined. The purpose of this study is to examine the direct effects of hospital volume, facility type, and travel distance on overall survival (OS) in patients undergoing surgery for PAC and characterize the indirect effects of patient-, disease-, and treatment-related mediating variables., Patients and Methods: Using the National Cancer Database, patients with non-metastatic PAC who underwent resection were stratified by annual hospital volume (< 11, 11-19, and ≥ 20 cases/year), facility type (AC versus non-AC), and TD (≥ 40 versus < 40 miles). Associations with survival were evaluated using multiple regression models. Effects of mediating variables were assessed using mediation analysis., Results: In total, 19,636 patients were included. Treatment at HVC or AC was associated with lower risk of death [hazard ratio (HR) 0.90, confidence interval (CI) 0.88-0.92; HR 0.89, CI 0.86-0.91, respectively]. TD did not impact OS. Patient-, disease-, and treatment-related variables explained 25.5% and 41.8% of the survival benefit attained from treatment at HVC and AC, reducing the survival benefit directly attributable to each variable to 4.9% and 6.4%, respectively., Conclusions: Treatment of PAC at HVC and AC was associated with improved OS, but the magnitude of this benefit was less when mediating variables were considered. From a healthcare utilization and cost-resource perspective, further research is needed to identify patients who would benefit most from selective referral to HVC or AC., (© 2022. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

We present an additional advantage of the Risk-Adjusted CUSUM (RA-CUSUM), namely, that its slope can be quantified and is in fact equivalent to Observed (O) minus Expected (E) mortality. That is, the height of the RA-CUSUM is the O minus E deaths, which measures performance since the start of the series, and the slope of the RA-CUSUM is the O minus E mortality which measures performance during a chosen interval. We present a useful graphical tool (Slope-Meter) to allow approximation of this mortality difference by the viewer., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Patients with small aortic annuli (SAA) are prone to higher post-transcatheter aortic valve replacement (TAVR) transvalvular gradients and development of prosthesis-patient mismatch (PPM). In many patients with SAA, the choice of TAVR valve commonly involves choosing between the 26-mm Medtronic Evolut 2 (ME26) or the 23-mm Edwards Sapien 3 valve (ES23). We compared echocardiographic and clinical outcomes in patients with SAA undergoing TAVR with either valve., Methods: We queried the Providence St. Joseph Health Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry database for patients undergoing TAVR with either the ES23 or ME26 between July 2015 and December 2018 at 11 hospitals. Post-TAVR echocardiographic and clinical results in-hospital, at 1 month, and at 1 year were examined. High gradient (HG) was defined as mean gradient (MG) ≥20 mm Hg., Results: We identified 1162 patients with SAA undergoing TAVR with either the ME26 (n = 233) or ES23 valve (n = 929). Baseline characteristics between groups were similar. At 1 month, the ME26 was associated with a lower MG than the ES23 (7.7 ± 4.7 mm Hg vs 13.1 ± 4.9 mm Hg; P<.001) and moderate or severe PPM (11% and 3% vs 27% and 13%; P<.001). Occurrence of HG at 1 year was lower with the ME26 valve vs the ES23 valve (0% vs 15%; P<.001). In-hospital and follow-up clinical outcomes to 1 year were similar for both groups., Conclusion: TAVR in SAA with the ME26 is associated with lower incidence of HG or PPM compared with the ES23. While clinical outcomes at 1 year were similar, the long-term implications of these findings remain unknown.

The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database is the world's premier adult cardiac surgery outcomes registry. This tutorial explains the following: how STS updates the risk models that are used to calculate the predicted risks of adverse events in the registry; why STS on a quarterly basis adjusts or "calibrates" the observed-to-expected ratios to equal 1 (O/E = 1), thereby effectively making the annual number of adverse events predicted by the model match the annual number of adverse events observed in the entire registry; the differences between the calibrated and uncalibrated O/E ratios; and how and when to use each., (Copyright © 2022 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Molecular testing on surgical specimens predicts disease recurrence and benefit of adjuvant chemotherapy in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early-stage breast cancer (EBC). Testing on core biopsies has become common practice despite limited evidence of concordance between core/surgical samples. In this study, we compared the gene expression of the 21 genes and the recurrence score (RS) between paired core/surgical specimens., Methods: Eighty patients with HR+/HER2- EBC were evaluated from two publicly available gene expression datasets (GSE73235, GSE76728) with paired core/surgical specimens without neoadjuvant systemic therapy. The expression of the 21 genes was compared in paired samples. A microarray-based RS was calculated and a value ≥ 26 was defined as high-RS. The concordance rate and kappa statistic were used to evaluate the agreement between the RS of paired samples., Results: Overall, there was no significant difference and a high correlation in the gene expression levels of the 21 genes between paired samples. However, CD68 and RPLP0 in GSE73235, AURKA, BAG1, and TFRC in GSE76728, and MYLBL2 and ACTB in both datasets exhibited weak to moderate correlation (r < 0.5). There was a high correlation of the microarray-based RS between paired samples in GSE76728 (r = 0.91, 95% confidence interval [CI] 0.81-0.96) and GSE73235 (r = 0.82, 95% CI 0.71-0.89). There were no changes in RS category in GSE76728, whereas 82% of patients remained in the same RS category in GSE73235 (κ = 0.64)., Conclusions: Gene expression levels of the 21-gene RS showed a high correlation between paired specimens. Potential sampling and biological variability on a set of genes need to be considered to better estimate the RS from core needle biopsy., (© 2021. Society of Surgical Oncology.)

Reporting of risk-adjusted surgical outcomes is commonly used to compare providers and track changes over time. Preferred graphical methods use the relationship of the observed to the expected values of outcome events, including their ratio (O/E), and the cumulative sum (CUSUM) of their differences over time, called Risk-Adjusted CUSUM (RA-CUSUM) or Variable Life Adjusted Display (VLAD). We demonstrate these methods using operative mortality data for 7255 isolated coronary artery bypass graft patients from January 2014 to June 2017. RA-CUSUM and VLAD are excellent techniques to display risk-adjusted outcomes and, unlike O/E, can provide continuous monitoring as performance varies over time., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: Aortic valve disease is the most frequent indication for heart valve replacement with the highest prevalence in elderly. Tissue-engineered heart valves (TEHV) are foreseen to have important advantages over currently used bioprosthetic heart valve substitutes, most importantly reducing valve degeneration with subsequent reduction of re-intervention. We performed early Health Technology Assessment of hypothetical TEHV in elderly patients (≥ 70 years) requiring surgical (SAVR) or transcatheter aortic valve implantation (TAVI) to assess the potential of TEHV and to inform future development decisions., Methods: Using a patient-level simulation model, the potential cost-effectiveness of TEHV compared with bioprostheses was predicted from a societal perspective. Anticipated, but currently hypothetical improvements in performance of TEHV, divided in durability, thrombogenicity, and infection resistance, were explored in scenario analyses to estimate quality-adjusted life-year (QALY) gain, cost reduction, headroom, and budget impact., Results: Durability of TEHV had the highest impact on QALY gain and costs, followed by infection resistance. Improved TEHV performance (- 50% prosthetic valve-related events) resulted in lifetime QALY gains of 0.131 and 0.043, lifetime cost reductions of €639 and €368, translating to headrooms of €3255 and €2498 per hypothetical TEHV compared to SAVR and TAVI, respectively. National savings in the first decade after implementation varied between €2.8 and €11.2 million (SAVR) and €3.2-€12.8 million (TAVI) for TEHV substitution rates of 25-100%., Conclusions: Despite the relatively short life expectancy of elderly patients undergoing SAVR/TAVI, hypothetical TEHV are predicted to be cost-effective compared to bioprostheses, commercially viable and result in national cost savings when biomedical engineers succeed in realising improved durability and/or infection resistance of TEHV.

To compare structural valve deterioration (SVD) among bioprosthetic aortic valve types, a PubMed search found 54 papers containing SVD-free curves extending to at least 10 years. The curves were digitized and fit to Weibull distributions, and the mean times to valve failure (MTTF) were calculated. Twelve valve models were collapsed into four valve types: Medtronic (Medtronic, Minneapolis, MN) and Edwards (Edwards Lifesciences, Irvine, CA) porcine; and Sorin (Sorin Group [now LivaNova], London, United Kingdom) and Edwards pericardial. Meta-regression found MTTF was associated with the patient's age, publication year, SVD definition, and valve type. Sorin pericardial valves had significantly lower risk-adjusted MTTF (higher SVD risk), and there were no significant differences in MTTF among the other three valve types., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Aim: To propose a method for estimating the lifetime advantage of statins., Methods: Kaplan-Meier survival curves from published 4S and LIPID studies with 5.8- and 6.1-year follow-up were digitized. Gompertz distributions were fit up to the end of the trials, and then extrapolated out to the end of the patients' predicted lifetimes for each study., Results: The method results in a 9.9 (95% CI: 8.7-11.9) and 2.8 (95% CI: 2.3-3.3) years' increases for the statin groups for 4S and LIPID studies, respectively., Conclusion: Previous analysis of the same data was limited by the trials' relatively short run time. As such, we propose a method for correctly estimating the true effect of statin therapy in terms of total lifetime extension.

Importance: It is difficult for neonatal intensive care units (NICUs) to determine the overall efficacy of multiple continuous quality improvement (CQI) projects aimed at reducing very low-birth-weight (VLBW) infant morbidities. It is challenging to know whether a NICU is becoming more proficient, and it is not usually apparent whether concurrent resource use is changing., Objective: To develop a risk-adjusted composite score of the major morbidities in VLBW infants and a companion metric that accounts for resource use to enhance the ability to measure overall progress in CQI and to identify proficient NICUs., Design, Setting, and Participants: This retrospective investigation used individual patient-level demographic and outcomes data from 8 NICUs who were long term CQI collaborators within the Vermont Oxford Network, a large international quality improvement organization dedicated to improving the care of premature infants. Study participants were infants who weighed 401 to 1500 g born from January 1, 2000, through December 31, 2011, at each of the 8 participating NICUs., Main Outcomes and Measures: Risk-adjusted, composite VLBW infant morbidity and resource utilization score., Results: A total of 15,961 infants (mean [SD] gestational age, 28.2 [3.0] weeks; mean [SD] birth weight, 1020 [306] g) were analyzed. Concurrent with multiple shared CQI projects over 12 years, the group benefit metric improved 38% from 80 in 2000 to 110 in 2011 (P < .001). The entire member VON benefit metric improved 28% from 72 in 2000 to 92 in 2011 (P < .001). The group value metric improved 25% from 1.2 in 2000 to 1.5 in 2011 (P < .001). The entire member VON value metric improved 18% from 1.1 in 2000 to 1.3 in 2011 (P < .001). Significant inter-NICU variation in both composite scores was noted in the 8 member CQI group. Hospital length of stay increased in the 8 NICUs 64 to 71 days (P <.001), and a similar increase was noted in the entire member VON, 65 to 68 days (P < .001)., Conclusions and Relevance: We have created the first, to our knowledge, web-based tool for NICUs to calculate their own composite morbidity and resource utilization scores that estimate NICU CQI proficiency. In our structured group CQI over 12 years, both metrics revealed significant improvement, but increases in length of stay (resource use) blunted value improvement. Why some NICUs improve their scores more successfully than others remains a crucial challenge. Future CQI efforts should explore strategies that cost-efficiently reduce intertwined VLBW infant morbidities, emphasizing whole cultures of proficient care rather than the traditional emphasis on single-morbidity reduction.

Outcomes of cardiothoracic surgery are usually compared among hospitals or physicians by reporting the frequency of in-hospital mortality. Although there is agreement that these frequencies should be adjusted for case mix, there remains uncertainty about the value of using a statistical model that represents hospitals as random effects as opposed to the conventional approach of fixed effects. For years, the Northern New England Cardiovascular Disease Study Group has compared in-hospital mortality after coronary artery bypass graft surgery among centers using a fixed effects approach. An alternative method using random effects has become increasingly popular, and is the method used by cardiothoracic surgery registries such as the Massachusetts Data Analysis Center. The purpose of this report is to provide a short background on fixed versus random effects modeling, describe the use of shrinkage estimators including empirical Bayes, and illustrate them using data from the Northern New England Cardiovascular Disease Study Group. We conclude that both are acceptable approaches to hospital profiling if done in combination with appropriate risk adjustment., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: The Data Monitoring Committee (DMC) for the premarket approval (PMA) study of a new heart valve prosthesis convenes periodically to review the accumulating results of the study, and determines, among other things, whether there is enough concern with safety to stop the study. Their deliberations are largely subjective, based on their combined experience and expertise, but an objective aid to evaluating complication rates, usually called a stopping rule, is desirable., Methods: The US Food and Drug Administration has designated objective performance criteria (OPC) for 7 heart valve complications. At the end of the PMA study, when approximately 800 patient-years have been accumulated, the complication rates must compare favorably with the OPC. Given the results to date at an interim review of the data, we use a Bayesian approach to compute the probability of passing the OPC test by the end of study., Results: We provide a method that the DMC can use to predict the probability of passing the OPC test for each complication, and a graphical aid for each number of events, observed at 100 patient-year intervals., Conclusions: Although the DMC ultimately uses combined experience and expertise to make the decision to stop a PMA valve study, we have provided an objective assessment of the probability of the valve ultimately passing the OPC test to aid in making that decision., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

This article summarizes the long-term clinical results of the Food and Drug Administration-approved heart valves, provides current updates to the objective performance criteria (OPC) used to evaluate new heart valve prostheses, and documents the steps that the International Organization for Standardization Committee used to arrive at the updated OPC. Data were extracted from 19 Food and Drug Administration summaries of safety and effectiveness data reports (31 series) and 56 literature articles (85 series) published from 1999 to 2012. The OPC were calculated for five valve-related complications by valve type (mechanical and bioprosthetic) and valve position (aortic and mitral)., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: New York (NY) valve and valve/coronary artery bypass grafting (CABG) mortality risk models, developed from operations performed in 2007 to 2009, have just been published. These models were validated using NY data from 2004 to 2006. The authors stated that their models "should also be validated by testing them against non-New York populations." Thus, we validated the NY models with the Providence Health & Services-Swedish Health Services (PH&S-SHS) cardiac surgical data and also compared them with The Society of Thoracic Surgeons (STS) mortality risk models., Methods: The PH&S-SHS validation data set contained 4,021 isolated valve and 2,406 valve/CABG operations, performed from 2008 to 2012. The risk models (NY logistic and score models and the STS models) were recalibrated to equalize the expected and observed number of deaths. Discrimination was tested by C statistics and calibration by Hosmer-Lemeshow statistics., Results: PH&S-SHS operative mortality rates were 2.6% and 5.5% in the valve and valve/CABG operations, respectively, and were lower than the NY rates. The C statistics for the NY logistic valve and valve/CABG models were 0.777 and 0.727, respectively, and were very similar for the NY score models. Calibration was good for the NY valve model (p=0.85), but not for the NY valve/CABG model (p=0.01). The STS models had better discrimination than NY models and good calibration., Conclusions: The NY logistic and score models for valve operations fit the PH&S-SHS data well with acceptable discrimination and good calibration. The NY models for valve/CABG operations fit the PH&S-SHS data with acceptable discrimination and poor calibration. STS logistic regression models fit the PH&S-SHS data somewhat better., (Copyright © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: In our effort to reduce the use of blood products in cardiac operations in a health care system, we noted variations in transfusion practices among facilities. Interestingly, surgeons practicing at the same hospital had similar transfusion rates. We sought to quantitate the contribution of hospital influence on individual surgeons' transfusion practices., Methods: Blood transfusion data for coronary artery bypass graft operations at 12 Providence Health & Services facilities between January 2008 and June 2011 were reviewed. Frequency of perioperative blood transfusion, amount of transfusion, components transfused, and timing of transfusions were compared. Variation among surgeons at the same institution vs between institutions was computed based on multilevel mixed-effect logistic and linear regression models. Intraclass correlation coefficients were calculated., Results: A total of 5,744 nonemergency first-time coronary artery bypass graft procedures were performed by 42 not-low volume (n>30 in 2.5 years) surgeons at 12 Providence Health & Services hospitals during the 3.5-year study period. Frequency, amount, timing, and blood component usage were different among facilities but relatively similar for surgeons within a facility. The variance of red blood cell transfusion rate among hospitals (.82) is more than two times that among surgeons practicing within the same hospital (.35). Thus, surgeons contribute 30% to the variation, and 70% of the total variation can be explained by the hospital effect., Conclusions: In our multihospital system, the hospital that a surgeon practices at plays a larger role in determining blood utilization than the individual surgeon's preference., (Copyright © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: To compare the probability, and modes, of explantation for Carpentier-Edwards pericardial versus porcine valves., Methods: Our porcine series began in 1974 and our pericardial series in 1991, with annual prospective follow-up. We used the Kaplan-Meier method and Cox regression for estimation and analysis of patient mortality, and the cumulative incidence function and competing risks regression for estimation and analysis of valve durability., Results: Through the end of 2010, we had implanted 506 porcine and 2449 pericardial aortic valves and 181 porcine and 163 pericardial mitral valves. The corresponding total and maximum follow-up years were 3471 and 24, 11,517 and 18, 864 and 22, and 645 and 9. The corresponding probabilities (cumulative incidence function) of any valve explant were 7%, 8%, 22%, and 8%, and of explant for structural valve deterioration were 4%, 5%, 16%, and 5% at 15 years for the first 3 series and at 8 years for the fourth (pericardial mitral valve) series. Using competing risks regression for structural valve deterioration explant, with age, gender, valve size, and concomitant coronary bypass surgery as covariates, a slight (subhazard ratio, 0.79), but nonsignificant, protective effect was found for the pericardial valve in the aortic position and a greater (subhazard ratio, 0.31) and almost significant (P = .08) protective effect of the pericardial valve in the mitral position. Leaflet tear was responsible for 61% of the structural valve deterioration explants in the porcine series and 46% in the pericardial series., Conclusions: Using competing risks regression, the pericardial valve had a subhazard ratio for structural valve deterioration explant of less than 1 in both positions, approaching statistical significance in the mitral position. The mode of structural valve deterioration was predominantly leaflet tear for porcine valves and fibrosis/calcification for pericardial valves., (Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Survival is an end point of immense interest in cardiothoracic research. In observational studies, the comparison of survival between groups of patients is usually accomplished using a toolbox that includes Kaplan-Meier survival curves and the Cox model. The Cox model yields comparisons between groups adjusted for case-mix differences, whereas the Kaplan-Meier is a plot of survival over time without adjustment. During the past decade, new methods have emerged for case-mix adjustment of survival curves and are increasingly being used in cardiothoracic research. The purpose of this report is to describe, illustrate, and review several approaches to case-mix adjusted survival (or event-free) curves., (Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

We compared hospital length of stay (LOS) and costs between (1) minimally invasive total hip surgery (MIS) combined with an active hip pathway (AHP) and (2) long incision total hip surgery (LIS) with a passive hip pathway (PHP). A prospective consecutive cohort of 214 MIS/AHP patients was compared to a concurrent cohort of 265 LIS/PHP patients. The MIS/AHP cohort had significantly decreased LOS (1.5 days vs. 3.8 days, P < .001) and hospital costs ($12.8 thousand vs. $16.7 thousand, P < .001). The complication rates were similar for MIS/AHP and LIS/PHP. We conclude that, compared to LIS/PHP, MIS/AHP significantly shortened LOS by an average of 2.3 days, and significantly reduced hospital costs by an average of $3.9 thousand per patient., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: The purpose of this study was to determine long-term patient survival and valve durability for Carpentier-Edwards pericardial valves (Edwards Lifesciences) implanted in the aortic position, with specific attention to the impact of patient age., Methods: We performed a retrospective cohort study of 2168 patients who underwent implantation of a Carpentier-Edwards pericardial aortic valve between 1991 and 2008. The mean follow-up time was 4.5 years. Primary outcomes of interest were mortality and valve explantation. Survival curves and event-free curves were obtained with the Kaplan-Meier method and compared with the log-rank test., Results: Survival was 92% at 1 year, 73% at 5 years, 38% at 10 years, and 18% at 15 years. Although the mortality rate of younger patients was worse than in the general population, older patients had significantly better survival than their contemporaries. Age was the independent variable most significantly associated with explantation. There was an early hazard phase for patients between 21 and 49 years of age, such that the freedom from explantation was 89% at 3 years. By 10 years, the freedom from explantation was 58% for patients 21 to 49 years of age, compared with 68% for patients 50 to 64 years, 93% for patients 65 to 74 years, and 99% for patients 75 years of age and older., Conclusion: We found good long-term survival and durability. Older patients had excellent freedom from explantation, whereas younger patients fared worse. As our population ages, this information becomes increasingly important. Assessing the durability of this pericardial aortic valve may aid in predicting the durability of the transcatheter aortic valves that share the same leaflets.

Background: No information exists evaluating the costs of complications or death after lobectomy or pneumonectomy., Methods: We analyzed hospital costs for 294 patients who underwent lobectomy (n=268) or pneumonectomy (n=26) from January 2005 through September 2007. The patients were categorized into two groups on the basis of clinical outcomes: uncomplicated versus complications or death. A cost prediction model was constructed with linear regression using uncomplicated patients only. The model was applied to the complications or death group to predict the expected cost as if they had no complication. The risk-adjusted cost of complications or death was quantified by the difference between the observed cost and the expected cost., Results: There were 241 patients in the uncomplicated group (19 pneumonectomy), and 53 patients had complications or death (7 pneumonectomy). Length of stay was shorter for uncomplicated versus complications or death for both lobectomy and pneumonectomy. Pneumonectomy was costlier than lobectomy. Experiencing complications or death was costlier than costs associated with uncomplicated cases. The actual cost for uncomplicated cases was $18,380. The expected cost for complications or death was similar to that for uncomplicated cases regardless of the number of complications or death. The mean risk-adjusted cost of complications (95% confidence interval) increased by the number of complications: $11,693 ($4,430 to $18,957), $26,673 ($12,320 to $41,025) and $128,450 ($93,971 to $162,930) for 1, 2, and 3 complications, respectively. It was $49,823 ($23,187 to $76,459) for death., Conclusions: Patients experiencing complications or death have a similar perioperative risk profile as patients without complications. Hospital death or postoperative complications after lobectomy or pneumonectomy are economically costly. Decreasing inpatient death or complications would result in substantial cost-of-care savings., (Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

In this article, we present 2-year clinical results of a modular neck tapered hip stem, based on 634 patients from a 2-center study. Nearly half of the patients in this series required use of a head center location offered by the modular neck stem but not available in a nonmodular stem with an identical body. The modular neck enabled femoral-first preparation, which facilitates establishing the desired total version of the reconstruction. No fractures of a stem or modular neck occurred, and there were no dissociations of the head-neck junction. There were no complications or revisions related to the femoral implant. Optimal leg length, femoral offset, and total version are goals in hip arthroplasty. Neck modularity improves the ability to re-create the head center to achieve these goals and to hit the "bull's-eye" in total hip arthroplasty.

The Society of Thoracic Surgeons National Adult Cardiac Surgery Database (STS NCD) has become the national benchmark for cardiac surgery reporting. Several important aspects of its risk-adjustment reporting are discussed, with special emphasis on using the reported individual STS risk scores for analysis and evaluation: (1) Different risk models are used in different STS NCD versions. (2) STS calibrates risk scores annually to make the annual predicted rates equal the observed rates. (3) The risk scores given by the STS, whether in the approved STS data collection software programs, published risk models, or online calculator, are not calibrated. (4) The end-user is required to calibrate the STS risk scores before using them. (5) After calibration, the STS predicted risk for any given patient is usually smaller, sometimes less than half of the uncalibrated value. (6) STS uses an observed/expected ratio method to calibrate the risk scores; for technical reasons, it is preferable to use an odds ratio method., (2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Coronary artery shunting during off-pump coronary artery bypass OPCAB procedures has been addressed only infrequently. To assess the protective effect of shunting, we examined CABG patients' postoperative cardiac enzyme levels and preoperative and postoperative ejection fractions., Methods: During OPCAB, we selectively shunted the left anterior descending coronary artery (LAD) to provide myocardial protection when ischemia developed. We prospectively gathered data from 408 consecutive patients who underwent OPCAB. Data on shunt status were available for 386 of these patients. A "flow-through" shunt providing perfusion to the distal LAD was used whenever ST-segment elevations greater than 2 mm occurred or when patients had hemodynamic compromise unexplained by cardiac manipulation. Ejection fraction was assessed 1 to 3 days preoperatively and again 3 to 10 days postoperatively. Creatine kinase (muscle/brain) levels were assessed postoperatively for 24 hours., Results: During OPCAB, 99 patients required shunting for presumed ischemia. Thirty-day cardiac mortality was 1.4% (4 of 296 without a shunt; 0 of 90 with a shunt). In patients without a LAD shunt, the mean peak creatine kinase index was 5.3; in patients who needed a shunt, the index was 5.2. Mean ejection fraction improved from 0.536 to 0.589 in the shunted patients and from 0.53.5 to 0.586 in the nonshunted patients., Conclusions: Selective shunting of the LAD during OPCAB provides effective protection against myocardial ischemia when ischemia is detected by electrocardiogram or when hypotension develops that is unexplained by cardiac manipulation., (2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Successful publication of a research study usually requires a small p value, typically p < 0.05. Many clinicians believe that a p value represents the probability that the null hypothesis is true, so that a small p value means the null hypothesis must be false. In fact, the p value provides very weak evidence against the null hypothesis, and the probability that the null hypothesis is true is usually much greater than the p value would suggest. Moreover, even considering "the probability that the null hypothesis is true" is not possible with the usual statistical setup and requires a different (Bayesian) statistical approach. We describe the Bayesian approach using a well-established diagnostic testing analogy. Then, as a practical example, we compare the p-value result of a study of aprotinin-associated operative mortality with the more illuminative interpretation of the same study data using a Bayesian approach.

Background: Mounting evidence exists for more restrictive blood transfusion practices in patients undergoing cardiac surgery. Few studies, however, have recognized or agree upon a method by which this decrease in allogeneic red blood cell transfusion can be achieved. We will review our methods and experience in a blood conservation initiative from 2003 to 2007., Methods: A data driven, multidisciplinary effort to decrease allogeneic red blood cell transfusion was instituted in a community hospital. Numerous innovations in treatment protocols were implemented and evaluated. Clinical data from 2003 to 2007 will be presented. Yearly review of outcomes led to an evolving clinical practice and lowered transfusion rates., Results: A total of 2,531 consecutive cardiac surgical procedures were performed during a five-year period. Using a multidisciplinary approach to quality improvement, and with the goal of using fewer blood products, our incidence of allogeneic red blood cell transfusion was decreased, from 43% in 2003 to 18% in 2007. Patient outcomes were not significantly changed., Conclusions: Cardiac surgery in a community hospital can be performed safely with low utilization of allogeneic red blood cell transfusions. A multidisciplinary approach to blood conservation can result in lower transfusion rates and equivalent patient outcomes.

Glomerular filtration rate (GFR) is an important clinical indicator of kidney function. It can be used as an independent predictor of long-term survival after cardiac surgery. Definition, methods of measurement, and corrected value by body surface area are briefly introduced in this paper. Details of the calculation of estimated GFR (eGFR) by Levey's formula with serum creatinine, age, gender, and race are offered. The relationship between estimated GFR and the four factors is shown graphically and discussed. An eGFR/creatinine conversion table for individual patients derived from the eGFR equation with clinically significant cutpoints is given, which can be used by physicians as a pragmatic reference.

Objective: Numerous reports have been published documenting the results of aortic valve replacement. It is often not easy to translate these outcomes involving the condition of the valve into the actual consequences for the patient. We previously developed an alternative method to study outcome after aortic valve replacement that allows direct estimation of patient outcome after aortic valve replacement: microsimulation modeling. The goal of this article is to provide insight into microsimulation methodology and to give an overview of the advantages and disadvantages of simulation methods (in particular microsimulation) in comparison with standard methods of outcome analysis., Methods: By using a primary dataset containing 1847 patients and 14,429 patient-years, advantages and disadvantages of standard methods of outcome analysis are discussed, and the potential role of microsimulation is illustrated by means of a step-by-step explanation of building, testing, and using such a model., Results: Total life expectancy, event-free life expectancy, and reoperation-free life expectancy for a 65-year-old male patient were 10.6 years, 9.2 years, and 9.8 years, respectively. Lifetime risk of reoperation due to structural valve deterioration was 13.3%., Conclusions: Microsimulation is capable of providing accurate estimates of age-related life expectancy and lifetime risk of reoperation for patients who underwent aortic valve replacement with the Carpentier-Edwards supra-annular valve. It provides a useful tool to facilitate and optimize the choice for a specific heart valve prosthesis in a particular patient.

Objective: Economists have designed frameworks to measure the economic value of improvements in health and longevity. Heart valve replacement surgery has significantly prolonged life expectancy and quality of life. For the example of aortic valve replacement, what is its economic value according to this framework?, Methods: From 1961 through 2003, a total of 4617 adult patients underwent aortic valve replacement by one team of cardiac surgeons. These patients were provided with a prospective lifetime follow-up service. As of 2005, observed follow-up was 31,671 patient-years, with a maximum of 41 years. A statistical model was used to generate the future life-years of patients currently alive. The value of life-years proposed by economists was applied to determine the economic value of the additional life given to these patients by aortic valve replacement., Results: The total life-years after aortic valve replacement were 53,323, with a gross value of 14.6 billion dollars. The total expected life-years without surgery were 10,157, with an estimated value of 3.0 billion dollars. Thus the net life-years gained by AVR were 43,166, worth 11.6 billion dollars. Subtracting the 451 million dollars total lifetime cost of surgery, the net value of the life-years gained by AVR was 11.2 billion dollars. The mean net value decreases according to age at surgery but is still worth 600,000 dollars for octogenarians and 200,000 dollars for nonagenarians., Conclusion: According to the economic concept of the value of a statistical life, the return on the investment for aortic valve replacement is enormous for patients of all ages, even very elderly patients.

Objective: With increased life expectancy and improved technology, valve replacement is being offered to increasing numbers of elderly patients with satisfactory clinical results. By using standard econometric techniques, we estimated the relative cost-effectiveness of aortic valve replacement by drawing on a large prospective database at our institution. By using aortic valve replacement as an example, this introductory report paves the way to more definitive studies of these issues in the future., Methods: From 1961 to 2003, 4617 adult patients underwent aortic valve replacement at our service. These patients were provided with a prospective lifetime follow-up. As of 2005, these patients had accumulated 31,671 patient-years of follow-up (maximum 41 years) and had returned 22,396 yearly questionnaires. A statistical model was used to estimate the future life years of patients who are currently alive. In the absence of direct estimates of utility, quality-adjusted life years were estimated from New York Heart Association class. The cost-effectiveness ratio was calculated by the patient's age at surgery., Results: The overall cost-effectiveness ratio was approximately 13,528 dollars per quality-adjusted life year gained. The cost-effectiveness ratio increased according to age at surgery, up to 19,826 dollars per quality-adjusted life year for octogenarians and 27,182 dollars per quality-adjusted life year for nonagenarians., Conclusions: Given the limited scope of this introductory study, aortic valve replacement is cost-effective for all age groups and is very cost-effective for all but the most elderly according to standard econometric rules of thumb.

Background: The Clinical Outcomes Assessment Program (COAP) from the state of Washington recently published a risk model for hospital mortality after percutaneous coronary intervention (PCI), which was validated by a consortium of hospitals in 4 northeastern states. The Providence Health System (PHS) Cardiovascular Study Group data was used to further validate this COAP model using data from PHS hospitals in 3 western states., Methods: All 13124 consecutive PCI procedures performed in 6 PHS hospitals from July 2001 through June 2004 were included. The c index was used to test model discrimination. The Hosmer-Lemeshow test, the le Cessie-van Houwelingen-Copas test, and the cumulative sum method were used to test model calibration., Results: The patient profiles of the COAP data and the PHS data were similar. The overall mortality was 1.6% for COAP and 1.4% for PHS. The subgroup mortalities were also similar. When applying the COAP model to the PHS data, the c index (95% CI) was 0.893 (0.859-0.928), indicating excellent discrimination, and the le Cessie-van Houwelingen-Copas test and the cumulative sum method showed good global goodness of fit., Conclusion: The COAP model for hospital mortality was successfully validated using PHS data. With the advance of technology and changing patient profile, PCI models must be periodically checked for possible updating to reflect contemporary practice. Predictors in a PCI risk model should be objective, have standard definitions, and be easy to obtain to facilitate the transportability of the model.

Background and Aim of the Study: The study aim was to update the authors' experience with the CarboMedics bileaflet mechanical prosthesis in terms of early and long-term outcomes., Methods: Between July 1994 and April 2005, a total of 774 CarboMedics valves was implanted at two Providence Health System hospitals in Portland Service Area. Of these valves, 406 (59%) were aortic valve replacements (AVR), 196 (28.5%) were mitral valve replacements (MVR), and 86 pairs (12.5%) were double valve replacements (DVR)., Results: The mean and maximum follow up was 4.6 and 10.2 years, respectively; total follow up was 3,150 patient-years (pt-yr) (total 3,503 valve-years). Operative mortality was 5.7% (4.4% for AVR, 7.7% for MVR, 7.0% for DVR). Five- and 10-year survivals respectively were 79 +/- 2% and 55 +/- 10% for AVR, 74 +/- 3% and 57 +/- 8% for MVR, and 64 +/- 6% and 39 +/- 11% for DVR (p = 0.009). Freedom from valve explant at five and 10 years respectively was 98 +/- 1% and 97 +/- 10% for AVR, 98 +/- 1% and 86 +/- 12% for MVR, and 96 +/- 3% and 96 +/- 3% for DVR (p = 0.950). Freedom from thromboembolism at five and 10 years respectively was 93 +/- 1% and 91 +/- 2% for AVR, 97 +/- 1% and 95 +/- 2% for MVR, and 90 +/- 4% and 90 4% for DVR (p = 0.226). Freedom from bleeding at five and 10 years respectively was 98 +/- 1% and 97 +/- 1% for AVR, 97 +/- 1% and 96 +/- 2% for MVR, and 91 +/- 4% and 91 +/- 4% for DVR (p = 0.006). Freedom from endocarditis at five and 10 years respectively was 99 +/- 1% and 99 +/- 1% for AVR, 98 +/- 1% and 98 +/- 1% for MVR, and 95 +/- 3% and 91 +/- 4% for DVR (p = 0.030). There were nine perivalvular leaks (six after AVR, three after MVR), and three valve thromboses (two after MVR, one after DVR). Freedom from overall valve-related events at five and 10 years respectively was 80 +/- 2% and 74 +/- 3% for AVR, 82 +/- 3% and 57 +/- 11% for MVR, and 69 +/- 6% and 66 +/- 6% for DVR (p = 0.074)., Conclusion: Long-term experience with the CarboMedics valve shows the clinical performance of the valve to be very good, with results comparable to those obtained with other mechanical valves.