Cost-effectiveness of coronary artery bypass grafting plus mitral valve repair versus coronary artery bypass grafting alone for moderate ischemic mitral regurgitation.

OBJECTIVE: The Cardiothoracic Surgical Trials Network reported that left ventricular reverse remodeling at 2 years did not differ between patients with moderate ischemic mitral regurgitation randomized to coronary artery bypass grafting plus mitral valve repair (n = 150) or coronary artery bypass grafting alone (n = 151). To address health resource use implications, we compared costs and quality-adjusted survival. METHODS: We used individual patient data from the Cardiothoracic Surgical Trials Network trial on survival, hospitalizations, quality of life, and US hospitalization costs to estimate cumulative costs and quality-adjusted life years. A microsimulation model was developed to extrapolate to 10 years. Bootstrap and deterministic sensitivity analyses were performed to address uncertainty. RESULTS: In-hospital costs were $59,745 for coronary artery bypass grafting plus mitral valve repair versus $51,326 for coronary artery bypass grafting alone (difference $8419; 95% uncertainty interval, 2259-18,757). Two-year costs were $81,263 versus $67,341 (difference 13,922 [2370 to 28,888]), and quality-adjusted life years were 1.35 versus 1.30 (difference 0.05; -0.04 to 0.14), resulting in an incremental cost-effectiveness ratio of $308,343/quality-adjusted life year for coronary artery bypass grafting plus mitral valve repair. At 10 years, its costs remained higher ($107,733 vs $88,583, difference 19,150 [-3866 to 56,826]) and quality-adjusted life years showed no difference (-0.92 to 0.87), with 5.08 versus 5.08. The likelihood that coronary artery bypass grafting plus mitral valve repair would be considered cost-effective at 10 years based on a cost-effectiveness threshold of $100K/quality-adjusted life year did not exceed 37%. Only when this procedure reduces the death rate by a relative 5% will the incremental cost-effectiveness ratio fall below $100K/quality-adjusted life year. CONCLUSIONS: The addition of mitral valve repair to coronary artery bypass grafting for patients with moderate ischemic mitral regurgitation is unlikely to be cost-effective. Only if late mortality benefits can be demonstrated will it meet commonly used cost-effectiveness criteria.

Contemporary trends and outcomes of mitral valve surgery for infective endocarditis.

BACKGROUND: Contemporary data on mitral valve (MV) surgery in patients with infective endocarditis (IE) are limited. METHODS: The National Inpatient Sample was queried to identify patients with IE who underwent MV surgery between 2003 and 2016. We assessed (a) temporal trends in the incidence of MV surgery for IE, (b) morbidity, mortality, and cost of MV repair vs replacement, and (c) predictors of in-hospital mortality. RESULTS: The proportion of MV operations involving patients with IE increased from 5.4% in 2003 to 7.3%, and the proportion of MV repair among those undergoing surgery for IE increased from 15.2% to 25.0% (Ptrend < .001). In-hospital mortality was higher in the replacement group (11.3% vs 8.1%; P < .001), and this excess mortality persisted after propensity score matching (11.2% vs 8.1%; P < .001), and in sensitivity analyses excluding concomitant surgery (unadjusted 11.3% vs 4.8%; adjusted 8.5% vs 4.5%; P < .001), and stratifying patients by the time of operation (within 7 days, 11.3% vs 6.8%; P < .001 and >7 days, 11.9% vs 9.1%; P = .012). In the propensity-matched cohorts, shock and need for tracheostomy were more frequent in the replacement group, but rates of stroke, pacemaker implantation, new dialysis, and blood transfusion were similar. Mitral valve repair was, however, associated with shorter hospitalizations, more home discharges, and less cost. In a multivariate regression analysis, age above 70 and chronic dialysis were the strongest predictors of in-hospital mortality. CONCLUSION: Mitral valve repair in IE patients is associated with lower in-hospital mortality, resource utilization, and cost compared with MV replacement.

Outcomes and Resource Utilization in Robotic Mitral Valve Repair: Beyond the Learning Curve.

BACKGROUND: After the initial learning curve associated with mastering a robotic procedure, there is a plateau where operative time and complication rates stabilize. Our objective was to evaluate one surgeon's experience with robotic mitral valve repairs (MVRep) beyond the learning curve and to compare its effectiveness against the traditional open approach. METHODS: Data from Ronald Reagan University of California, Los Angeles Medical Center was prospectively collected from January 2008 to March 2016 to identify adult patients undergoing robotic MVRep. Operative times, complication rates, and cost for robotic versus open MVRep were compared using multivariate regressions, adjusting for comorbidities and previous cardiac surgeries. RESULTS: During the study period, 175 robotic (41%) and 259 open (59%) MVRep cases were performed at our institution. As the surgeon performed more robotic operations, there was a decrease in room time (554-410 min, P < 0.001), surgery time (405-271 min, P < 0.001), and cross-clamp times (179-93 min, P < 0.001). After application of a multivariate regression model, robotic MVRep was associated with lower odds of complications (odds ratio = 0.42, P = 0.001), shorter length of stay (ß = -2.51, P < 0.001), and a reduction of 11% in direct (P = 0.003) and 24% in room costs (P < 0.001), but a 51% increase in surgery cost (P < 0.001). CONCLUSIONS: As the surgeon gained experience with robotic MVRep, operative times decreased in a steady manner. Robotic MVRep had comparable outcomes to open MVRep and lower overall cost. The observed difference in costs is likely related to shorter length of stay and lower room cost with the robotic approach.

Incidence and outcomes of early percutaneous coronary intervention after isolated valve surgery.

BACKGROUND: Coronary ischemia requiring early percutaneous coronary intervention (PCI) is a rare but serious complication of isolated valve surgery. We sought of assess the incidence, predictors and outcomes of early PCI after isolated valve surgery using the national inpatient sample. METHODS: Patients who underwent isolated aortic valve replacement (AVR), isolated mitral valve repair (MVr) or replacement (MVR) between 2003 and 2014 were identified. Patients who had early postoperative PCI were compared with patients who did not require PCI. Primary end point was in-hospital mortality. Secondary endpoints were complications, length-of-stay and cost. RESULTS: Among the 135,611 included patients, 1,074 (0.8%) underwent PCI prior to discharge. Unadjusted in-hospital mortality was higher in patients requiring early PCI following AVR (11.2 vs. 3.1%), MVR (24.1 vs. 5.5%), and MVr (22.4 vs. 2.5%) (P < 0.001) compared with patients not requiring PCI. Postoperative PCI remained independently associated with higher mortality after adjusting for demographics, comorbidities and hospital characteristics (adjusted OR [aOR] = 3.74, 95%CI 2.70-5.17 for AVR, aOR = 6.10, 95%CI 4.53-8.23 for MVR, and aOR = 9.90, 95%CI 7.22-13.58 for MVr). Patients undergoing PCI had higher incidences of stroke, acute kidney injury, infectious complications, higher hospital charges, and longer hospitalizations. Age, robotic-assisted surgery, and chronic renal failure were independent predictors of needing early postoperative PCI. CONCLUSIONS: Early PCI after isolated aortic or mitral valve surgery is rare but is associated with substantial in-hospital morbidity, mortality, and cost. Further studies are needed to identify preventable causes, and optimal management strategies of this serious complication.

Robotic mitral valve operations by experienced surgeons are cost-neutral and durable at 1 year.

BACKGROUND: Robotic mitral valve surgery has potential advantages in patient satisfaction and 30-day outcome. Cost concerns and repair durability limit wider adoption of robotic technology. This study examined detailed cost differences between robotic and sternotomy techniques in relation to outcomes and durability following robotic mitral program initiation. METHODS: Between April 2013 and October 2015, 30-day and 1-year outcomes of 328 consecutive patients undergoing robotic or sternotomy mitral valve repair or replacement by experienced surgeons were examined. Multivariable logistic regression informed propensity matching to derive a cohort of 182 patients. Echocardiographic follow-up was completed at 1 year in all robotic patients. Detailed activity-based cost accounting was applied to include direct, semidirect, and indirect costs with special respect to robotic depreciation, maintenance, and supplies. A quantitative analysis of all hospital costs was applied directly to each patient encounter for comparative financial analyses. RESULTS: Mean predicted risk of mortality was similar in both the robotic (n = 91) and sternotomy (n = 91) groups (0.9% vs 0.8%; P > .431). The total costs of robotic mitral operations were similar to those of sternotomy ($27,662 vs $28,241; P = .273). Early direct costs were higher in the robotic group. There was a marked increase in late indirect cost with the sternotomy cohort related to increased length of stay, transfusion requirements, and readmission rates. Robotic repair technique was associated with no echocardiographic recurrence greater than trace to only mild regurgitation at 1 year. CONCLUSIONS: Experienced mitral surgeons can initiate a robotic program in a cost-neutral manner that maintains clinical outcome integrity as well as repair durability.

Cost-Effectiveness of Mitral Valve Repair Versus Replacement for Severe Ischemic Mitral Regurgitation: A Randomized Clinical Trial From the Cardiothoracic Surgical Trials Network

BACKGROUND: The CTSN (Cardiothoracic Surgical Trials Network) recently reported no difference in left ventricular end-systolic volume index or in survival at 2 years between patients with severe ischemic mitral regurgitation (MR) randomized to mitral valve repair or replacement. However, replacement provided more durable correction of MR and fewer cardiovascular readmissions. Yet, costeffectiveness outcomes have not been addressed. METHODS AND RESULTS: We conducted a cost-effectiveness analysis of the surgical treatment of ischemic MR based on the CTSN trial (n=126 for repair; n=125 for replacement). Patient-level data on readmissions, survival, qualityof- life, and US hospital costs were used to estimate costs and quality-adjusted life years per patient over the trial duration and a 10-year time horizon. We performed microsimulation for extrapolation of outcomes beyond the 2 years of trial data. Bootstrap and deterministic sensitivity analyses were done to address parameter uncertainty. In-hospital cost estimates were $78 216 for replacement versus $72 761 for repair (difference: $5455; 95% uncertainty interval [UI]: −7784­21 193) while 2-year costs were $97 427 versus $96 261 (difference: $1166; 95% UI: −16 253­17 172), respectively. Quality-adjusted life years at 2 years were 1.18 for replacement versus 1.23 for repair (difference: −0.05; 95% UI: −0.17 to 0.07). Over 5 and 10 years, the benefits of reduction in cardiovascular readmission rates with replacement increased, and survival minimally improved compared with repair. At 5 years, cumulative costs and quality-adjusted life years showed no difference on average, but by 10 years, there was a small, uncertain benefit for replacement: $118 023 versus $119 837 (difference: −$1814; 95% UI: −27 144 to 22 602) and qualityadjusted life years: 4.06 versus 3.97 (difference: 0.09; 95% UI: −0.87 to 1.08). After 10 years, the incremental cost-effectiveness of replacement continued to improve. CONCLUSIONS: Our cost-effectiveness analysis predicts potential savings in cost and gains in quality-adjusted survival at 10 years when mitral valve replacement is compared with repair for severe ischemic MR. These projected benefits, however, were small and subject to variability. Efforts to further delineate predictors of long-term outcomes in patients with severe ischemic MR are needed to optimize surgical decisions for individual patients, which should yield more cost-effective care. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00807040.

Evaluation of robotic cardiac surgery simulation training: A randomized controlled trial.

OBJECTIVE: To compare the currently available simulation training modalities used to teach robotic surgery. METHODS: Forty surgical trainees completed a standardized robotic 10-cm dissection of the internal thoracic artery and placed 3 sutures of a mitral valve annuloplasty in porcine models and were then randomized to a wet lab, a dry lab, a virtual reality lab, or a control group that received no additional training. All groups trained to a level of proficiency determined by 2 expert robotic cardiac surgeons. All assessments were evaluated using the Global Evaluative Assessment of Robotic Skills in a blinded fashion. RESULTS: Wet lab trainees showed the greatest improvement in time-based scoring and the objective scoring tool compared with the experts (mean, 24.9 ± 1.7 vs 24.9 ± 2.6; P = .704). The virtual reality lab improved their scores and met the level of proficiency set by our experts for all primary outcomes (mean, 24.9 ± 1.7 vs 22.8 ± 3.7; P = .103). Only the control group trainees were not able to meet the expert level of proficiency for both time-based scores and the objective scoring tool (mean, 24.9 ± 1.7 vs 11.0 ± 4.5; P < .001). The average duration of training was shortest for the dry lab and longest for the virtual reality simulation (1.6 hours vs 9.3 hours; P < .001). CONCLUSIONS: We have completed the first randomized controlled trial to objectively compare the different training modalities of robotic surgery. Our data demonstrate the significant benefits of wet lab and virtual reality robotic simulation training and highlight key differences in current training methods. This study can help guide training programs in investing resources in cost-effective, high-yield simulation exercises.

Effect of Hospital Volume on Outcomes of Transcatheter Mitral Valve Repair: An Early US Experience.

BACKGROUND: Transcatheter mitral valve repair (TMVR) is a complex procedure for patients with mitral regurgitation who cannot get surgery. However, there is a lack of data on how hospital volumes affect these outcomes. METHODS: We performed a cross sectional study based on Healthcare Cost and Utilization Project's Nationwide Inpatient Sample database of 2012 and identified subjects using the ICD-9-CM procedure code of 35.97, which was introduced in October 2010 for percutaneous mitral valve repair if present in the primary or secondary procedure field. Hospital volumes were divided into tertiles. The primary outcome was a composite of in-hospital mortality and peri-procedural complications. Length of stay and hospitalization cost were also assessed. RESULTS: A total of 95 (weighted n = 475) TMVR procedures were identified. The mean age of the overall cohort was 70 years; 43.2% were female and 63.2% had a significant baseline burden of co-morbidities. The composite of in-hospital mortality and peri-procedural complications decreased with increasing TMVR hospital volume: 48.7% in the first tertile, 17.4% in the second tertile, and 9.1% in the third tertile. Additionally, we saw a decrease in the length of stay and a trend in decrease in the hospitalization cost. CONCLUSION: In hospitals performing TMVR, higher hospital volumes are associated with a reduction in a composite of in-hospital mortality and post-procedural complications, in addition to the shorter length of stay.

Single-Center Experience With Adjustable Annuloplasty Ring in Degenerative Mitral Regurgitation.

OBJECTIVE: Owing to the complex anatomy of the mitral valve, successful surgical repair of degenerative regurgitation remains a challenging procedure in cardiac surgery. METHODS: This paper aimed to report on our single-center experience with 20 patients who received an adjustable annuloplasty ring (Cardinal ring, ValtechCardio Ltd, Or Yehuda, Israel) as part of their mitral valve repair procedure. The device allows for intraoperative echocardiography-guided ring size adjustments under beating-heart conditions. RESULTS: All of the 20 patients left the operating room without any residual mitral regurgitation. There was no risk of systolic anterior movement (SAM) because of image-guided fine tuning of the ring before weaning the patient from bypass. CONCLUSIONS: Further multicenter data are required to prove the concept of adjustable annuloplasty devices.

Trends, clinical outcomes, and cost implications of mitral valve repair versus replacement, concomitant with aortic valve replacement.

OBJECTIVE: This study evaluated national trends, clinical outcomes, and cost implications of mitral valve (MV) repair, versus replacement, concomitant with aortic valve replacement (AVR). METHODS: Patients who underwent MV surgery concomitant with AVR, between 1999 and 2008, were identified in the Nationwide Inpatient Sample (NIS) registry. Mitral stenosis, endocarditis, and emergency cases were excluded. Inpatient clinical outcomes and costs were compared. Costs were derived using cost-to-charge ratios supplied by the dataset for each individual hospital. Multivariable logistic and linear regression analyses were used for risk adjustment. RESULTS: A total of 41,417 concomitant cases were identified, of which 11,472 (28%) were MV repairs. Repair rates increased from 15.3% in 1999 to 43.5% in 2008 (P < .001). Major postoperative morbidity rates were similar with MV repair, versus replacement, concomitant with AVR (each 29%, P = .54). Unadjusted inpatient mortality (7.9% vs 10.1%, P = .005); length of hospital stay (median: 8 vs 9 days, P < .001); and costs (median: $45,455 vs $49,648, P < .001) were lower with MV repair. After risk adjustment, MV repair was associated with lower odds of inpatient mortality, and with lower costs (each P < .001). CONCLUSIONS: Mitral valve repair concomitant with AVR is associated with reduced inpatient mortality and costs, compared with MV replacement, supporting its use when technically feasible. Although use has increased substantially, MV repair continues to comprise a minority of concomitant AVR cases, in centers reporting to the NIS registry. Increasing repair rates, particularly in NIS-participating hospitals, seems prudent.

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

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

Is robotic mitral valve surgery more expensive than its conventional counterpart?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was 'Is robotic mitral valve surgery more expensive than its conventional counterpart?' Altogether 19 papers were found using the reported search, of which 5 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. There is a general impression in the surgical community that robotic operations might incur prohibitive additional costs. There is a paucity of data in the literature regarding cost analysis in cardiac robotic surgery. From the five studies, four were single institution experiences and one was a database inquiry study. These four studies showed that operational costs are higher for robotic cases but this was partially (one study) or completely (three studies) offset by lower postoperative costs. Overall hospital costs were similar between the two approaches in three studies and one study showed higher costs in the robotic group. Higher operating theatre (OT) costs were driven mainly by use of robotic instruments (approximately US$1500 per case) and longer OT times. Savings in postoperative care were driven by shorter length of hospital stay (on average 2 days fewer in robotic cases) and lower morbidity. If amortization cost, that is, the value of the initial capital investment on the robotic system divided by all operations performed, is included in this analysis, robotic approach becomes significantly more expensive by approximately US$3400 per case. The fifth study was a large national database inquiry in which robotic approach was found to be more expensive by US$600 per case excluding amortization cost and by US$3700 if amortization is included. We conclude that the total hospital cost of robotic mitral valve surgery is slightly higher than conventional sternotomy surgery. If amortization is taken into consideration, robotic cases are considerably more expensive.

Interventional treatment for structural heart disease: who is deciding, and can we afford it?

During the last years, the numbers of interventions in structural heart disease such as transcatheter aortic valve implantation (TAVI), percutaneous treatment of mitral regurgitation using the MitraClip, closure of atrial septal defects (ASD) and others have constantly increased. While the 20th century was called the century of surgery, it appears that the present century might be the century of minimally invasive percutaneous therapy. The reduced invasiveness of these procedures and the success in elderly patients make these treatments increasingly attractive for younger and healthier patients. Now that these procedures are moving forward, some questions arise, namely, who is deciding on treatment modality, and can we afford it?

The challenges of managing rheumatic disease of the mitral valve in Jamaica.

Between January, 2009 and December, 2013, 84 patients were identified who underwent isolated mitral valve surgery in Jamaica at The University Hospital of the West Indies and The Bustamante Hospital for Children. The most common pathology requiring surgery was rheumatic heart disease, accounting for 84% of the procedures performed. The majority of patients had regurgitation of the mitral valve (67%), stenosis of the mitral valve (22%), and mixed mitral valve disease (11%). The most common procedure performed was replacement of the mitral valve (69%), followed by mitral valve repair (29%). Among the patients, one underwent closed mitral commissurotomy. The choice of procedure differed between age groups. In the paediatric population (<18 years of age), the majority of patients underwent repair of the mitral valve (89%). In the adult population (18 years and above), the majority of patients underwent mitral valve replacement (93%). Overall, of all the patients undergoing replacement of the mitral valve, 89% received a mechanical valve prosthesis, whereas 11% received a bioprosthetic valve prosthesis. Of the group of patients who underwent mitral valve repair for rheumatic heart disease, 19% required re-operation. The average time between initial surgery and re-operation was 1.2 years. Rheumatic fever and rheumatic heart disease remain significant public health challenges in Jamaica and other developing countries. Focus must remain on primary and secondary prevention strategies in order to limit the burden of rheumatic valvulopathies. Attention should also be directed towards improving access to surgical treatment for young adults.

Relationship between patient income level and mitral valve repair utilization.

BACKGROUND: The superiority of mitral valve (MV) repair is well established with respect to long-term survival, preservation of ventricular function, and valve-related complications. The relationship between patient income level and the selection of MV procedure (repair versus replacement) has not been studied. METHODS: The 2005 to 2007 Nationwide Inpatient Sample database was searched for patients ≥ 30 years old with MV repair or replacement; patients with ischemic and congenital MV disease were excluded. Patients were stratified into quartiles according to income level (quartile 1, lowest; quartile 4, highest). We used univariate and multivariate models to compare patients with respect to baseline characteristics, selection of MV procedure, and hospital mortality. RESULTS: The preoperative profiles of the income quartiles differed significantly, with more risk factors occurring in the lower income quartiles. Unadjusted hospital mortality decreased with increasing income quartile. The percentage of patients receiving MV repair increased with increasing income (35.6%, 39.6%, 48.2%, and 55.8% for quartiles 1, 2, 3, and 4, respectively; P = .0001). Following adjustment for age, race, sex, urban residency, admission status, primary payer, Charlson comorbidity index, and hospital location and teaching status, the income quartiles had similar hospital death rates, whereas the highly significant relationship between valve repair and income level persisted (P = .0008). CONCLUSIONS: Significant disparity exists among patients in the different income quartiles with respect to the likelihood of receiving MV repair. MV repair is performed less frequently in patients with lower incomes, even after adjustment for differences in baseline characteristics. The higher unadjusted mortality rate for less affluent patients appears mostly related to their worse preoperative profiles.