Savings associated with surgical aortic valve replacement with a RESILIA tissue valve based on seven-year COMMENCE trial results.

BACKGROUND: Bioprostheses with RESILIA tissue demonstrate a reduction in calcification and improve health outcomes in pre-clinical and clinical studies. Prior economic analyses which relied on 5 years of evidence from the COMMENCE trial demonstrate financial savings for RESILIA tissue valves relative to mechanical valves after surgical aortic valve replacement (SAVR). Given the recent release of 7-year COMMENCE data, this economic evaluation updates the estimate for long-run savings of bioprosthetic valves with RESILIA. METHODS: Simulation models estimated disease progression across two hypothetical SAVR cohorts (tissue vs. mechanical) of 10,000 patients each in the US. The primary comparison calculated the SAVR-related expenditures associated with each valve type ($US, 2023). Health outcome probabilities were based on the COMMENCE trial though year 7 and projected for an additional 8 years based on prior studies of tissue and mechanical SAVR. Costs for key outcomes (mortality, reoperation, bleeding, thromboembolism, endocarditis) and anticoagulant monitoring were sourced from the literature. Incidence rates of health outcomes associated with mechanical valves relied on relative risks of tissue valve versus mechanical valve patients. RESULTS: Seven-year savings are $13,415 (95% CI = $10,472-$17,321) per patient when comparing RESILIA versus mechanical SAVR. Projected 15-year savings were $23,001 ($US, 2023; 95% CI = $17,802-$30,421). Most of the 15-year savings are primarily attributed to lower anti-coagulation monitoring costs ($21,073 in ACM savings over 15 years), but lower bleeding cost (savings: $2,294) and thromboembolism-related expenditures (savings: $852) also contribute. Reoperation and endocarditis expenditures were slightly larger in the RESILIA cohort. If reoperation relative risk reverts from 1.1 to 2.2 (the level in legacy tissue valves) after year 7, savings are $18,064. RESILIA SAVR also reduce costs relative to legacy tissue valves. CONCLUSION: Patients receiving RESILIA tissue valves are projected to have lower SAVR-related health expenditures relative to mechanical and legacy tissue valves.

Early vs late cardiac surgery in patients with native valve endocarditis-United States Nationwide Inpatient database.

OBJECTIVE: Although the standard treatment of infective endocarditis (IE) is antimicrobial therapy, surgical intervention is required in some cases. However, the optimal timing of surgery remains unclear. Hence, we conducted a population-based analysis using the National Inpatient Sample (NIS) database to assess the outcomes of early versus late surgery in patients with native valve IE. METHODS: We queried the NIS database for all hospitalized patients between 2006 and 2016 with a primary diagnosis of IE who had cardiac surgery. We stratified surgery as early ≤7 or late >7 days of admission. Multivariable logistic regression models were used to assess in-hospital mortality and postoperative complications. Length of stay (LOS) and total hospital cost (HC) were evaluated using multivariable log-normal regression models. RESULTS: A total of 13 056 patients (57.6% in the early group and 42.4% in the late group) were included. The in-hospital mortality rate in the early group was 5.0% compared to 5.4% in the late intervention group (adjusted odds ratio, 1.20, 95% confidence interval [CI] 0.79-1.81). Overall median LOS was reduced in the early group by 48.2% (95% CI, 46.5%-49.9%, 12.4 days in the early group and 25.9 days in late group), as well as HC which was reduced in the early group by 28.3% (95% CI, 26.0%-30.6%). CONCLUSION: Among patients with native valve IE who needed cardiac surgery, the time of surgical intervention did not affect the in-hospital mortality. However, early surgery was associated with significantly shorter LOS and lower HC.

Thirty-Day Readmission After Infective Endocarditis: Analysis From a Nationwide Readmission Database.

Background The contemporary incidence of and reasons for early readmission after infective endocarditis ( IE ) are not well known. Therefore, we analyzed 30-day readmission demographics after IE from the US Nationwide Readmission Database. Methods and Results We examined the 2010 to 2014 Nationwide Readmission Database to identify index admissions for a primary diagnosis of IE with survival at discharge. Incidence, reasons, and independent predictors of 30-day unplanned readmissions were analyzed. In total, 11 217 patients (24.8%) were nonelectively readmitted within 30 days among the 45 214 index admissions discharged after IE . The most common causes of readmission were IE (20.5%), sepsis (8.7%), complications of device/graft (8.1%), and congestive heart failure (7.6%). In-hospital mortality and the valvular surgery rates during the readmissions were 8.1% and 9.1%, respectively. Discharge to home or self-care, undergoing valvular surgery, aged ≥60 years, and having private insurance were independently associated with lower rates of 30-day readmission. Length of stay of ≥10 days, congestive heart failure, diabetes mellitus, renal failure, chronic pulmonary disease, peripheral artery disease, and depression were associated with higher risk. The total hospital costs of readmission were $48.7 million per year (median, $11 267; interquartile range, $6021-$25 073), which accounted for 38.6% of the total episodes of care (index+readmission). Conclusions Almost 1 in 4 patients was readmitted within 30 days of admission for IE . The most common reasons were IE , other infectious causes, and cardiac causes. A multidisciplinary approach to determine the surgical indications and close monitoring are necessary to improve outcomes and reduce complications in in-hospital and postdischarge settings.

Clinical and economic outcomes of infective endocarditis.

BACKGROUND: In France, the estimated annual incidence of infective endocarditis (IE) is 33.8 cases per million residents. Valvular surgery is frequently undergone. We report an epidemiological and economic study of IE for 2007-2009 in a French region, using the hospital discharge database (HDD). METHODS: The population studied concerned all the patients living in Centre region, France, hospitalized for IE. We extracted hospital stay data for IE from the regional HDD, with a definition based on IE-related diagnosis codes. The predictive positive value (PPV) and sensitivity (Se) of the definition were 87.4% and 90%, respectively, according to the Duke criteria (definite IE frequency 74.4%). Hospitalization costs were estimated, taking into account the fixed hospital charges of the diagnosis-related group (DRG) and supplementary charges due to intensive care unit (ICU) stay. RESULTS: The analysis included 578 patients. The annual average incidence was 45.4 cases per million residents. Valvular surgery was performed in 19.4% of cases. The hospital mortality was 17.6%. Multivariate analysis identified as risk factors for mortality an age ≥ 70 years (odds ratio (OR) = 3.03, 95% confidence interval (CI) = 1.78-5.18), staphylococcal IE (OR = 3.3, 95% CI = 1.9-5.7), chronic renal insufficiency (OR = 2.04, 95% CI = 1.00-4.15), ischemic stroke (OR = 2.55, 95% CI = 1.19-5.47), and hemorrhagic stroke (OR = 5.7, 95% CI = 1.9-17.3). The average cost per episode was $20 103 (€15 281). CONCLUSIONS: We report a higher incidence of IE than described by the French national study of 2008. Valvular surgery was considerably less frequent than in the published data, whereas mortality was similar. IE generates substantial costs.

Valve surgery for infective endocarditis is associated with high hospital charges.

BACKGROUND AND AIM OF THE STUDY: Half of all patients with infective endocarditis (IE) will require early surgical intervention, and another 40% will eventually undergo surgical treatment for their disease. Although the surgical management of IE is effective, the financial impact of the disease has never been assessed. METHODS: All patients who underwent valve surgery for native valve IE at the present authors' institution over a 10-year period (1996-2006) were reviewed retrospectively. Hospital charges were identified and adjusted to reflect US$ in 2006. A logistic regression analysis was performed to identify factors affecting charges and the patients' length of stay (LOS). RESULTS: A total of 369 patients (252 males, 117 females; mean age 53 +/- 15 years) underwent surgery for IE. Of these patients, 121 (33%) had preoperative renal failure and 70 (20%) were intravenous drug users. In addition, 159 patients (43%) had aortic IE, 112 (30%) had mitral IE, and 45 (12%) had both aortic and mitral valve IE. Right- and left-sided IE was identified in 42 patients (11%), and 11 (3%) had isolated right-sided IE. The median hospital charges were US$ 60,072 (interquartile range (IQR) US$ 39,386-103,960), with a median LOS of 15 days (IQR 9-29 days). Both, hospital charges and LOS were higher for patients undergoing emergent operations, or those with active IE (p < 0.001). The 30-day mortality was 2.7%. Regression analyses showed preoperative renal failure (p = 0.007), intraoperative transfusion (p = 0.028) and postoperative gastrointestinal complications (p < 0.001), renal failure (p = 0.012), heart block (p < 0.001), in-hospital mortality (p < 0.001), and patients undergoing emergent procedures (p < 0.001), or with active infection (p < 0.001) to be associated with significantly increased hospital charges. Factors that significantly affected LOS were other non-white race (p = 0.039), postoperative gastrointestinal complications (p = 0.001), stroke (p = 0.014), heart block (p < 0.001), and patients undergoing emergent procedures (p < 0.001) or with active infection (p < 0.001). CONCLUSION: The present series was among the largest to include patients with IE, and the first in which risk factors were assessed for increased hospital charges and resource utilization following surgery for endocarditis. Operations for IE are associated with a significant financial burden to the healthcare system, despite a relatively low percentage of complications. Patients with significant preoperative comorbidities, those with postoperative complications, and those who underwent emergent procedures or who had active IE, were associated with a prolonged LOS and increased hospital charges.

Drug cost implications for antibiotic prophylaxis for dental procedures.

OBJECTIVE: To determine the potential economic impact from the practice of antibiotic prophylaxis for dental procedures. STUDY DESIGN: We estimated the prevalence of patients in the United States with 15 medical conditions and devices. We multiplied the prevalence for each patient population by the percentage of specialists recommending prophylaxis, then by the estimated number of dental office visits per year, and then by an average pharmacy cost to arrive at a total estimated range of annual cost for this practice. RESULTS: The 15 medical conditions and devices included in the present study involve upward of 20 million people and an estimated annual cost between $19,880,279 and $143,685,823. The actual cost may be far greater because of an underestimation of these prevalence figures and the use of antibiotic prophylaxis for additional patient populations. CONCLUSIONS: Our data suggest a significant cost for antibiotic prophylaxis in the dental practice setting and the need for evidence-based recommendations concerning this practice.

Echocardiographic risk stratification for early surgery with endocarditis: a cost-effectiveness analysis.

BACKGROUND: Despite widespread acceptance of echocardiography for diagnosis of infective endocarditis, few investigators have evaluated its utility as a risk-stratification tool to aid therapeutic decision-making. METHODS: A decision tree and Markov analysis model were constructed using published and institutional data to estimate the cost-effectiveness of an echocardiographic risk-stratification strategy for infective endocarditis. The models compared surgery for high-risk patients based on clinical factors ("standard care") and surgery for high-risk patients based on echocardiographic findings ("echocardiography-guided"). RESULTS: The cost per patient for standard care and echocardiography-guided strategies was $47,766 and $53,669, respectively. The expected quality-adjusted life years (QALY) for standard care and echocardiography-guided strategies were 5.86 years and 6.10 years, respectively. Compared with standard care, the echocardiography-guided strategy cost an additional $23,867 per QALY saved. In one-way sensitivity analyses, the incremental cost of this strategy remained <$50,000/QALY across a broad range of scenarios. Baseline stroke risk had the greatest effect on cost-effectiveness. For populations with stroke risk less than 3.65%, the echocardiography-guided strategy was not cost-attractive (ICER >$50,000/QALY). At stroke risk between 3.65% and 14%, the ICER for the echocardiography-guided strategy was attractive (<$50,000 /QALY). The echocardiography-guided strategy became economically dominant at any baseline stroke risk greater than 18.3%. CONCLUSION: Echo-guided risk stratification for early surgery in patients with large vegetations is a cost-attractive treatment strategy for IE, as it improves outcome for an incremental cost <$50,000/QALY.

The cost of treating heart valve related complications.

BACKGROUND AND AIM OF THE STUDY: Heart valve replacement can result in serious complications. Therefore, it is important in decision making regarding the choice of valves to know the cost of such complications. METHODS: Complications were defined according to guidelines proposed by the Society of Thoracic Surgeons. They included valve thrombosis, embolism, hemorrhage due to anticoagulation, non-structural dysfunction, structural deterioration and endocarditis. The costs of the pre-admission assessment, acute inpatient stay, inpatient physician fees, post-discharge and out-patient physician fees were estimated for each complication to determine the average total cost in 1995 US dollars. Cost inputs were obtained from existing Massachusetts databases and Medicare fee schedules. RESULTS: The costs of managing valve thrombosis, endocarditis and non-structural dysfunction were all estimated to exceed $30,000 for a single event. The costs of acute management of embolism and anticoagulant-related hemorrhage were between $8,000 and $11,500. However, it is of note that managing the sequelae of an embolism was calculated to be greater than $70,000 over 15 years. The greatest contributor to the average cost of treating a complication was determined to be the in-patient facility cost. CONCLUSIONS: Complications related to heart valve replacement can be very costly to manage in both the short term and the long term.

Consequences of intravascular catheter sepsis.

Intravascular (IV) catheter sepsis is a widely recognized complication of IV therapy or monitoring, but little emphasis has been placed on the morbidity and cost associated with this infection. To assess the consequences of IV catheter sepsis, we examined the medical records of 94 patients with 102 episodes of IV catheter sepsis due to percutaneously inserted catheters. Major complications occurred in 33 (32%) of the episodes and included septic shock (12 episodes), sustained sepsis (12), suppurative thrombophlebitis (7), metastatic infection (5), endocarditis (2), and arteritis (2). One patient died due to sepsis, and hospital stay was clearly prolonged in 15 episodes. The risk of major complications was highest in episodes of IV catheter sepsis caused by Candida, Pseudomonas aeruginosa, Staphylococcus aureus, or multiple pathogens, and the most severe complications were usually caused by S. aureus. The hospital cost of IV catheter sepsis was assessed by reviewing medical and billing records to identify extra medical care and then multiplying charges for that care by the appropriate cost-to-charge ratio. The average cost per episode, adjusted to 1991 dollars, was $3,707 for all episodes and $6,064 for episodes caused by S. aureus. The morbidity and cost associated with IV catheter sepsis warrant substantial efforts to minimize the incidence of this complication and especially to prevent cases due to S. aureus.