3D mitral annulus echocardiography assessment in patients affected by degenerative mitral regurgitation who underwent mitral valve repair with flexible band.

BACKGROUND: Degenerative mitral valve (MV) regurgitation (DMR) shows significative mitral annulus (MA) alterations; mitral valve repair (MVR) seeks to restore annular geometry and function, and the current use of flexible band seams to respect most annular mobility reducing parietal stress. Parameters of MV geometry obtained by 3D transesophageal echocardiography (3D-TTE) analysis are crucial for surgical planning and postoperative success. The aim of this study was to assess, by means of a dedicated software, the variations of MA geometry and function in patients affected by DMR compared to controls and after MVR with flexible band. METHODS: We enrolled 32 patients (cases) with severe DMR who underwent MVR using flexible band; we compare this group with 20 controls. The TEE with 3D MV images acquisition was performed in both groups and then analyzed in postprocessing by using a dedicated software. RESULTS: There were no anthropometrics differences between cases and controls, both presented normal left ventricular ejection fraction. DMR group showed a significant increase of annulus dimensional parameters (p = .001) and alteration of nonplanarity comparing to controls (p < .05). The annuloplasty with flexible band induces a considerable reduction of MV dimensions comparing to preoperative data and restores physiological mobility and nonplanarity. There were no statistical differences between postoperative DMR and controls data, except for nonplanarity parameters (p ~.05), maybe influenced by hemodynamic settings. CONCLUSIONS: MVR with annuloplasty using flexible band appears able to reinstate a more physiological anatomic conformation of the MA, without compromising its dynamic properties.

Numerical modeling for efficiency and endurance assessment of an indirect mitral annuloplasty device.

In recent years, several transcatheter systems have been introduced for treatment of common mitral regurgitation (MR). Such a system that is based on indirect mitral annuloplasty (IMA) is currently indicated for functional MR. Very few clinical studies have been performed to assess the efficiency and durability of such devices, despite their high risk of fracture resulting from ongoing exposure to large cyclic deformations. In this study, numerical models of moderate primary MR were created to test the implantation procedure of a customized IMA device and its sealing efficiency. The ability of the implanted device to reduce systolic leakage was evaluated and affirmed with a model of a more generic device. The long-term durability of the device was tested using a range of Nickel Titanium material properties. Our results demonstrated a considerable reduction in leakage for both the simplified generic device and the more detailed customized device models. The device met different fatigue criteria, confirming its resiliency and safety even after 10 years, even under the harsher conditions of primary MR. This is the first study to assess the performance and fatigue risk of IMA devices for the treatment of more complicated MR conditions. These findings may pave the way for further research to ultimately consider the device in selective cases of PMR.

Echocardiographic Assessment of the Mitral Valve for Suitability of Repair: An Intraoperative Approach From a Mitral Center.

Intraoperative echocardiography of the mitral valve in the precardiopulmonary bypass period is an integral part of the surgical decision-making process for assessment of suitability for repair. Although there are comprehensive reviews in the literature regarding echocardiographic examination of the mitral valve, the authors present a practical stepwise algorithmic workflow to make objective recommendations. Advances in echocardiography allow for quantitative geometric analyses of the mitral valve, along with precise assessment of the valvular apparatus with three-dimensional echocardiography. In the precardiopulmonary bypass period, echocardiographers are required to diagnose and quantify valvular dysfunction, assess suitability for repair, assist in annuloplasty ring sizing, and determine the success or failure of the surgical procedure. In this manuscript the authors outline an algorithmic approach to intraoperative echocardiography examination using two-dimensional and three-dimensional modalities to objectively analyze mitral valve function and assist in surgical decision-making.

Comparison of In-Hospital Outcomes of Transcatheter Mitral Valve Repair in Patients With vs Without Pulmonary Hypertension (From the National Inpatient Sample).

Pulmonary hypertension (PH) is common in patients with left heart disease and is present in varying degrees in patients with severe mitral valve disease. There is paucity of data regarding outcomes following transcatheter mitral valve repair (TMVr) in patients with PH. For this study, we analyzed NIS data from 2014 to 2018 using the ICD-9-CM and 10-CM codes. Baseline characteristics were compared using a Pearson chi-squared test for categorical variables and independent samples t-test for continuous variables. To account for selection bias, a 1:1 propensity match cohort was derived using logistic regression. Trend analysis was- done using linear regression. Of 21,505 encounters, 6780 encounters had PH. 6610 PH encounters were matched with 6610 encounters without PH. In-hospital mortality (3.3% versus 1.9%, p <0.01) was higher in PH population. Complications such as blood transfusion (3.6% versus 1.7%, p <0.01), GI bleed (1.4% versus 1%, p = 0.04), vascular complications (5.3% versus 3.3%, p <0.01), vasopressors use (2.9% versus 1.7%, p <0.01) and pacemaker placement (1.3% versus 0.8%, p = 0.01) remained significantly higher for encounters with PH. Multiple Logistic regression showed PH was associated with higher mortality (adjusted odds ratio [AOR], 1.68 [95% confidence interval [CI], 1.39-2.05], p <0.01). The mean length of stay (6.2 versus 5.3 days, p <0.01) and cost per hospitalization ($53,780 versus $50,801, p <0.01) remained significantly higher in the PH group when compared to group without PH. In conclusion, TMVr in PH as compared to without PH is associated with higher mortality, post-procedure complication rates, length of stay, and cost of stay.

Impact of Economic Status on Utilization and Outcomes of Transcatheter Aortic Valve Implantation and Mitraclip.

Data on the impact of economic status on Transcatheter aortic valve implantation (TAVI) and MitraClip (MC) is lacking. Patients who underwent TAVI and/or MC during 2012 to 2017 were identified in the Nationwide Readmission Database and divided by zip code estimated income quartile into 4 groups (Q1 to Q4). The utilization of TAVI and/or MC was defined as the number of TAVIs and/or MCs over all admissions with an aortic and/or mitral valve disease (AVD and/or MVD) and represented per 1,000 admissions. A total of 168,853 patients underwent TAVI; 20.6% in Q1, 26.3% in Q2, 27.3% in Q3, and 25.8% in Q4, while 15,387 patients underwent MC; 22% in Q1, 26.2% in Q2, 26.3% in Q3, and 25.5% in Q4. The annual utilization of TAVIs and/or MCs increased over the study period and was generally lower with lower income. In 2012, TAVI was performed for 8.2, 8.8, 10.8, and 11.3 per 1,000 AVD admissions in Q1, Q2, Q3, and Q4, respectively. In 2017, TAVI was performed for 54.1, 65.1, 68.6, and 71 per 1,000 AVD admissions in Q1, Q2, Q3, and Q4, respectively. In 2014, MC was performed for 1.6, 2.1, 1.8, and 1.9 per 1,000 MVD admissions in Q1, Q2, Q3, and Q4, respectively. In 2017, MC was performed for 5.6, 6.5, 8, and 8 per 1,000 MVD admissions in Q1, Q2, Q3, and Q4, respectively. In-hospital mortality, stroke, and 30-day readmissions were generally comparable across groups. Lower-income patients may be underrepresented among patients undergoing TAVI and MC despite comparable outcomes. Further studies are needed to examine the etiologies behind these disparities and identify targeted strategies for its mitigation.

Analysis of Atrial Fibrillation Treatment Regimes in a Multicenter Cohort of Transcatheter Edge-to-Edge Mitral Valve Repair Patients.

BACKGROUND: Atrial fibrillation (AF) is a highly prevalent comorbidity in patients with severe mitral valve regurgitation (MR). Recent studies show a deleterious outcome of patients with concomitant AF after transcatheter mitral valve repair (TMVR). This underlines the essential need for additional strategies that ameliorate the prognosis of these patients. Fundamental data on AF characteristics and treatment regimes in this special cohort of patients are lacking. METHODS: We retrospectively analyzed the data of 542 consecutive patients with severe MR undergoing TMVR in three tertiary heart centers with special focus on AF type and underlying treatment strategies. RESULTS: The prevalence of concomitant AF was 73.3%, and AF did not affect the procedural success or the incidence of major adverse cardiac and cerebrovascular events. The patients with AF were more frequently >75 years, had more tricuspid regurgitation, and less coronary artery disease than non-AF patients. The distribution of AF types was 32% paroxysmal AF, 27% persistent AF, and 41% permanent AF. Except for a higher degree in severe tricuspid regurgitation and a higher likelihood of male sex, no substantial differences were observed while comparing permanent and nonpermanent AF patients. The predominant treatment regime was rate control (57%), with only beta blockers (BB) in the majority of persistent and permanent AF patients, while additional digitalis or a pacemaker was used infrequently. Rhythm control was mainly achieved with BB alone in paroxysmal AF patients and with additional antiarrhythmic drugs in the majority of persistent AF patients. Interventional rhythm control therapy was performed in 2.5% and 30.9% of paroxysmal and persistent AF patients, respectively. The guideline-adherent use of oral anticoagulants was comparable and high in both groups (91.9% in nonpermanent vs. 90.1% in permanent AF). CONCLUSION: This is the first study to provide necessary information for the understanding of the current clinical practice in dealing with TMVR patients. Since evidence suggests that AF is not a benign concomitant disease, further investigations are needed to assess the prognostic impact of these different AF treatment strategies.

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.

Intraoperative assessment of mitral valve repair: Validation of the saline test with nonresectional repair techniques.

BACKGROUND AND AIM: Intraoperative assessment of the repaired mitral valve (MV) by saline testing is a standard maneuver in MV repair. Despite a growing interest in application of nonresectional techniques, the utility of the saline test following repair with neochordae has not been systematically assessed. We sought to determine the accuracy of the saline test following MV repair using nonresectional techniques. MATERIALS AND METHODS: We included 25 adult patients undergoing MV repair for degenerative valve disease between November 2018 and February 2019. The surgical repair was performed using nonresectional techniques with neochordae either through a sternotomy or a robotic approach. RESULTS: Twenty-five patients underwent successful MV repair, all with excellent echocardiographic results. In four patients (16%), the saline test suggested discrete areas of leaflet malcoaptation and leakage, leading to additional repair maneuvers. In 16 patients (64%), the final saline test demonstrated excellent coaptation with little or no leak. In nine patients (36%), the final saline test was inconclusive (ventricle could not be filled) or poor (diffuse leak). Post-repair intraoperative echocardiography demonstrated no or trivial mitral regurgitation in all patients, and no patient required a second pump run. CONCLUSION: After repair with neochordae, a satisfactory saline test indicates a good repair and discrete leaks on the saline test suggest the need for further surgical maneuvers. If the surgeon has employed standard repair techniques using neochordae but the saline test is inconclusive or poor, additional repair maneuvers are generally unnecessary, as intraoperative echocardiography will usually demonstrate a good repair.

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.

Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failure and Secondary Mitral Regurgitation: Design and rationale of the COAPT trial.

BACKGROUND: Patients with heart failure (HF) and symptomatic secondary mitral regurgitation (SMR) have a poor prognosis, with morbidity and mortality directly correlated with MR severity. Correction of isolated SMR with surgery is not well established in this population, and medical management remains the preferred approach in most patients. The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial was designed to determine whether transcatheter mitral valve (MV) repair with the MitraClip device is safe and effective in patients with symptomatic HF and clinically significant SMR. STUDY DESIGN: The COAPT trial is a prospective, randomized, parallel-controlled, open-label multicenter study of the MitraClip device for the treatment of moderate-to-severe (3+) or severe (4+) SMR (as verified by an independent echocardiographic core laboratory) in patients with New York Heart Association class II-IVa HF despite treatment with maximally tolerated guideline-directed medical therapy (GDMT) who have been determined by the site's local heart team as not appropriate for MV surgery. A total of 614 eligible subjects were randomized in a 1:1 ratio to MV repair with the MitraClip plus GDMT versus GDMT alone. The primary effectiveness end point is recurrent HF hospitalizations through 24 months, analyzed when the last subject completes 12-month follow-up, powered to demonstrate superiority of MitraClip therapy. The primary safety end point is a composite of device-related complications at 12 months compared to a performance goal. Follow-up is ongoing, and the principal results are expected in late 2018. CONCLUSIONS: HF patients with clinically significant SMR who continue to be symptomatic despite optimal GDMT have limited treatment options and a poor prognosis. The randomized COAPT trial was designed to determine the safety and effectiveness of transcatheter MV repair with the MitraClip in symptomatic HF patients with moderate-to-severe or severe SMR.

Automated Titanium Fasteners Versus Hand-Tied Knots: A Randomized Controlled Trial.

BACKGROUND: The relative benefits of automated titanium fasteners (LSI Solutions, Victor, NY) have not been examined in patients undergoing sternotomy. The aim of this study was to assess the time and cost required for suture fixation with the automated device versus conventional hand tying in sternotomy for mitral or tricuspid ring annuloplasty. METHODS: Fifty patients scheduled to undergo primary mitral or tricuspid, or both, ring annuloplasty-based valve repair operation by a single surgeon were randomly assigned to receive either conventional hand-tied knots or automated titanium fasteners, with 25 patients in each group. The primary outcome variable was the time required to affix the annuloplasty device to the valve annulus. RESULTS: The times taken to affix a mitral annuloplasty band or ring were 6.1 ± 0.9 min for manual tying versus 3.1 ± 0.4 min for automated fasteners (p < 0.0001); when calculated per annuloplasty stitch, the values were 22 ± 2 s versus 12 ± 1.1 s, respectively (p < 0.0001). The corresponding values for tricuspid annuloplasty were 4.2 ± 1.2 min (hand tying) versus 2.2 ± 0.3 min (automated fasteners) (p = 0.0005), and the times for each suture were 20 ± 2.1 s versus 13 ± 2 s, respectively (p = 0.0004). The use of the automated fastener had no significant impact on aortic cross-clamp time or cardiopulmonary bypass duration. Total cost associated with annuloplasty fixation with automated titanium fasteners (device cost in addition to operating room time cost) was significantly higher than with hand tying ($1,190 ± 374 vs $164 ± 60; p < 0.0001). CONCLUSIONS: Using the automated fastener to facilitate annuloplasty fixation through a sternotomy resulted in a small procedural time savings (average of 10 s/stitch) that had no overall impact on cardiopulmonary bypass or cross-clamp times but added an average cost of $1,026 to the operation.

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.