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.

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.

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.

Assessment of Mitral Valve Repair With Exercise Echocardiography: Artificial Chordae vs Leaflet Resection.

Mitral valve (MV) repair with artificial chordae (AC) or leaflet resection (LR) is associated with good hemodynamics at rest. The aim of this study was to compare these techniques in terms of exercise capacity and echocardiographic parameters of hemodynamics at rest and peak exercise. We conducted a study in 2015 of 56 patients, who had undergone surgery for degenerative posterior mitral leaflet prolapse between 2005 and 2014 using either AC (n = 24) or LR (n = 32). Clinical data were collected, exercise capacity was measured, and resting echocardiography and peak exercise echocardiography were performed. No significant differences were detected among groups regarding exercise duration or peak exercise workload measured in Watts (W) (AC: 136 ± 43 W and LR: 131 ± 40 W; P = 0.65). The mean mitral gradient at rest was 3.0 ± 1.3 mm Hg in the AC group and 3.0 ± 1.0 mm Hg in the LR group (P = 0.90). The mean MV gradients at peak exercise did not differ significantly between groups (AC: 8.3 ± 3.4 and LR: 11.3 ± 8.7; P = 0.19). Four patients (17%) in the AC group and 1 (3%) in the LR group had systolic anterior motion, P = 0.15. We conclude that both methods of posterior MV leaflet repair were associated with good hemodynamics at rest and peak exercise. The groups had comparable exercise capacity. MV pressure gradients at rest and peak exercise were similar in both groups.

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.

Assessment of mitral annuloplasty ring by cardiac computed tomography: Correlation with echocardiographic parameters and comparison between two different ring types.

OBJECTIVES: This study investigated computed tomographic (CT) appearance after mitral ring annuloplasty, especially comparing CT findings between patients with normal pressure gradient (PG) and patients with functional mitral stenosis (MS) and between 2 commonly used types of annuloplasty ring. METHODS: A total of 45 cardiac CT scans in patients who underwent mitral ring annuloplasty (Carpentier-Edwards ring, n = 27; Duran ring, n = 18) were retrospectively reviewed. On CT scan, presence of significant pannus around the annuloplasty ring, presence of leaflet thickening, and maximal mitral opening area were analyzed. CT findings were compared between patients with normal PG and patients with functional MS (mean diastolic PG ≥ 5 mm Hg). Incidences of functional MS and CT findings were compared between ring types. RESULTS: Significant pannus was present in 10 cases and leaflet thickening in 31 cases, and maximal opening area was 2.34 ± 0.717 cm(2). Valve opening area on CT was positively correlated with mitral valve area on transthoracic echocardiography and negatively correlated with mean diastolic PG. Mean diastolic PG was significantly elevated with increasing pannus severity. Patients with functional MS had more significant pannus than patients with normal PG. The Duran ring group had higher mean diastolic PG, smaller mitral valve area, and higher incidence of functional MS than the Carpentier-Edwards ring group (P < .05). The proportion of pannus and significant pannus was significantly higher in the Duran ring group (P < .05). CONCLUSIONS: Significant pannus around the annuloplasty ring on CT may cause functional MS after mitral ring annuloplasty. This may occur more frequently with the Duran ring.

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.

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.

Five-year real world outcomes of GeoForm ring implantation in patients with ischemic mitral regurgitation.

BACKGROUND: Reductive ring annuloplasty represents the current standard surgical therapy for ischemic mitral regurgitation (IMR); however, the clinical results have been suboptimal. Etiology-specific prostheses such as the GeoForm annuloplasty ring have been designed to better address the annular and subvalvular perturbations associated with IMR. However, clinical experience is limited, and mid-term results are lacking. METHODS: We reviewed the clinical outcomes of 86 patients who had undergone implantation of a GeoForm ring at our center from 2005 to 2011. Perioperative mortality and clinical parameters were derived from The Society of Thoracic Surgeons database. Follow-up survival was assessed using the Social Security Death Index. Surviving patients were interviewed by telephone for valve-specific follow-up data and to complete the Medical Outcomes Study, short-form, 36-item, quality-of-life questionnaire. RESULTS: The mean grade of IMR preoperatively was 3.1±0.8 (range, 1-4+), 0.2±0.4 in the immediate postoperative period, and 0.7±0.7 at the last mean follow-up point of 41 months; only 2 patients developed ≥2+IMR during the follow-up period, for a 5-year freedom from recurrent 2+ IMR of 86%. The mean left ventricular end-diastolic and end-systolic diameters decreased from before to after surgery from 6.0±0.0 cm to 5.3±09 cm and 5.0±0.9 cm to 4.3±1.1 cm, respectively (P<.001). Perioperative mortality was 5.8% (5 of 86), and 1-, 3-, and 5-year survival was 87%, 81%, and 75%, respectively. At the last follow-up point, 80% of patients were in New York Heart Association class I and II, and their quality of life was equal to, or better than, age-matched controls from the general population. CONCLUSIONS: Implantation of the GeoForm ring offers very good control of IMR, with low rate of recurrent IMR at mid-term follow-up. The use of this prosthesis was associated with good perioperative mortality, mid-term survival, and quality of life.

Comparison of the health related quality of life of patients following mitral valve surgical procedures in the 6-months follow-up: a prospective study.

PURPOSE: The aim of the present study is to evaluate the health-related quality of life of the patients who underwent mitral valve repair (MvRp) and mitral valve replacement (MVR). METHODS: Within the scope of this prospective study design, 56 patients who had mitral valve operation between the years of 2011-2012 were enrolled in the study. 24 (42.8%) of these patients had MVR while 32 (57.1%) of them had MvRp. The health-related quality of life was evaluated according to the Turkey norms of Short Form 36 Quality-Of-Life Measures (SF-36), which were filled in by the patients before and 6 months after the operation. Moreover, preoperative risk factors affecting the quality of life (age, gender, functional capacity, rhythm, hypertension, diabetes, applied surgical method and echocardiographic results) were investigated for all the patients (n = 56) by using independent sample t test analysis. RESULTS: When the pre and postoperative changes were compared between the two groups, it was found out that there were no significant difference between the groups in terms of restraints on physical role functioning (PR), and the social role functioning values (SF) (respectively; p = 0.097, p = 0.105). However, in the comparison of pre-/postoperative changes between the groups, the changes in physical functioning (PF), bodily pain (BP), general health (GH), vitality (VT) and restraints on emotional role functioning (RE) and mental health (MH) values were found out to be significantly superior in the MvRp group than in the MVR group (respectively; p <0.01, p <0.05, p <0.01, p <0.01, p <0.05 and p <0.01). It was also confirmed that female gender, atrial fibrillation (AFR), and MVR method negatively affected the physical and mental components (respectively; p = 0.033, p = 0.003, p = 0.015). CONCLUSION: RESULTS of the SF-36 quality of life measures show that quality of life may be better in patients that have had MvRp. It should be considered that the planned surgical treatment method can affect the patient's quality of life, and this effect can indicate the success of the surgical treatment.

[A comparative assessment of immediate results of correction of mitral insufficiency from the left-auricular and transventruicular accesses in patients with postinfarction aneurysm].

Reconstruction of postinfarction aneurysm of the left ventricle (LV) and plasty of the mitral valve without implantation in combination with coronary shunting or without it were used in 81 patients with ischemic heart disease. Correction of mitral insufficiency was fulfilled in 40 patients by an access via the left atrium, in 41 patients--from the LV in its reconstruction. Lethality in the nearest postoperative period was 3.7%. Mitral insufficiency after operation was absent in 70% of patients with the left atrium access and in 58.5% with the transventricular access, in the rest of the patients the mitral insufficiency was not more than of the II degree. Significant differences between the immediate results depending on the access to the mitral valve were not found.

Serial multidetector computed tomography assessment of left ventricular reverse remodeling, mass, and regional wall stress after restrictive mitral annuloplasty in dilated cardiomyopathy.

OBJECTIVE: To evaluate serial data on left ventricular and myocardial reverse remodeling after restrictive mitral annuloplasty. METHODS: Thirteen patients (age, 64 ± 6 years) with functional mitral regurgitation associated with dilated cardiomyopathy (ejection fraction, ≤ 35%) were examined before (baseline), soon (1.7 ± 1.5 months), and more than 1 year (16 ± 8 months) after restrictive mitral annuloplasty using multidetector computed tomography. The left ventricular end-diastolic and end-systolic volume indexes, left ventricular ejection fraction, left ventricular mass index, and end-systolic wall stress were estimated. RESULTS: In the period soon after restrictive mitral annuloplasty, significant reverse left ventricular remodeling was present, with decreases in the left ventricular end-diastolic volume index (149 ± 42 to 119 ± 41 mL/m(2), P = .04) and left ventricular end-systolic volume index (114 ± 44 to 78 ± 43 mL/m(2), P = .02), and an increase in left ventricular ejection fraction (25% ± 10% to 37% ± 14%, P = .01). Additional changes in these parameters were seen in the later period (103 ± 29 mL/m(2), 61 ± 23 mL/m(2), and 42% ± 9%, respectively; all P < .05 vs baseline). In the early postrestrictive mitral annuloplasty period, the left ventricular mass index did not change significantly (104 ± 22 to 104 ± 18 g/m(2), P = NS), but significant regression occurred in the later period (90 ± 17 g/m(2), P < .05 vs baseline). The end-systolic wall stress was significantly decreased in the early period (P < .05) and was sustained in the late period. Furthermore, the increase in left ventricular ejection fraction in the late period correlated significantly with the magnitude of the end-systolic wall stress reduction (r = -0.67, P = .01). CONCLUSIONS: Our findings indicate that ventricular reverse remodeling occurs soon after restrictive mitral annuloplasty. In contrast, myocardial reverse remodeling (ie, regression of myocardial hypertrophy) occurs over time between the early and late postoperative periods. Our data also suggest that the late improvement in left ventricular systolic performance might be attributable to a decrease in the left ventricular afterload.