Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation.

BACKGROUND: Tricuspid regurgitation is common in patients with severe degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform tricuspid-valve repair during mitral-valve surgery in patients who have moderate tricuspid regurgitation or less-than-moderate regurgitation with annular dilatation. METHODS: We randomly assigned 401 patients who were undergoing mitral-valve surgery for degenerative mitral regurgitation to receive a procedure with or without tricuspid annuloplasty (TA). The primary 2-year end point was a composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death. RESULTS: Patients who underwent mitral-valve surgery plus TA had fewer primary-end-point events than those who underwent mitral-valve surgery alone (3.9% vs. 10.2%) (relative risk, 0.37; 95% confidence interval [CI], 0.16 to 0.86; P = 0.02). Two-year mortality was 3.2% in the surgery-plus-TA group and 4.5% in the surgery-alone group (relative risk, 0.69; 95% CI, 0.25 to 1.88). The 2-year prevalence of progression of tricuspid regurgitation was lower in the surgery-plus-TA group than in the surgery-alone group (0.6% vs. 6.1%; relative risk, 0.09; 95% CI, 0.01 to 0.69). The frequencies of major adverse cardiac and cerebrovascular events, functional status, and quality of life were similar in the two groups at 2 years, although the incidence of permanent pacemaker implantation was higher in the surgery-plus-TA group than in the surgery-alone group (14.1% vs. 2.5%; rate ratio, 5.75; 95% CI, 2.27 to 14.60). CONCLUSIONS: Among patients undergoing mitral-valve surgery, those who also received TA had a lower incidence of a primary-end-point event than those who underwent mitral-valve surgery alone at 2 years, a reduction that was driven by less frequent progression to severe tricuspid regurgitation. Tricuspid repair resulted in more frequent permanent pacemaker implantation. Whether reduced progression of tricuspid regurgitation results in long-term clinical benefit can be determined only with longer follow-up. (Funded by the National Heart, Lung, and Blood Institute and the German Center for Cardiovascular Research; ClinicalTrials.gov number, NCT02675244.).

The role of surgery for secondary mitral regurgitation and heart failure in the era of transcatheter mitral valve therapies.

The approach to the management of mitral valve (MV) disease and heart failure (HF) has dramatically changed over the last decades. It is well recognized that severe mitral regurgitation secondary to ischemic or non-ischemic cardiomyopathy is associated with an excess risk of mortality. Understanding the impact of the surgical treatment modality on mortality outcomes has been difficult due to the broad spectrum of secondary mitral regurgitation (SMR) phenotypes and lack of randomized surgical clinical trials. Over the last 30 years, surgeons have failed to provide compelling evidence to convince the medical community of the need to treat SMR in patients with severe HF. Therefore, the surgical treatment of SMR has never gained uniform acceptance as a significant option among patients suffering from SMR. Recent evidence from randomized trials in a non-surgical eligible patients treated with transcatheter therapies, has provided a new perspective on SMR treatment. Recently published European and American guidelines confirm the key role of percutaneous treatment of SMR and in parallel, these guidelines reinforce the role of mitral valve surgery in patients who require surgical revascularization. Complex mitral valve repair combining subvalvular apparatus repair along with annuloplasty seems to be a promising approach in selected patients in selected centers. Meanwhile, mitral valve replacement has become the preferred surgical strategy in most patients with advanced heart failure and severe LV remodeling or high risk of recurrent mitral regurgitation. In this comprehensive review, we aimed to discuss the role of mitral surgery for SMR in patients with heart failure in the contemporary era and to provide a practical approach for its surgical management.

Smartphone-based app for evaluating cardiothoracic residents: Feasibility and engagement.

PURPOSE: Timely and high-quality feedback is important in cardiothoracic (CT) surgery education. Feedback on operative proficiency is an area for improvement in CT surgery programs. Traditional evaluations significantly lag behind operative interactions. We hypothesized that use of the System for Improving and Measuring Procedural Learning (SIMPL) app would improve operative feedback for trainees. METHODS: Use of SIMPL was evaluated from December 2018 to January, 2021 within an academic CT surgery training program. Ratings include level of supervision, complexity of the operation, and trainee performance. Completion was limited to 72 h after the operation. Descriptive statistics of the users and ratings are presented. RESULTS: Over 28 months, 816 evaluations were completed, and of these, 495 had a rating from both the faculty and trainee. There were 19 trainees representing post-graduate years 1-8 and 19 faculty members who received or submitted at least one evaluation over the study period. The number of evaluations for each trainee ranged from 1 to 166 and from 1 to 81 for each of the faculty. The response rate for faculty ranged from 0% to 100%. "Active help" was the most common type of supervision (50.7% by the faculty, 60.4% from the trainees). CONCLUSIONS: Use of SIMPL within a CT surgery training program was feasible and engagement was observed from both trainees and faculty. SIMPL provided trainees with timely, concise feedback on operative performance. Further work will focus on correlating SIMPL ratings with pre-existing assessments of performance.

Six-Month Performance of a 3-Dimensional Annuloplasty Ring for Repair of Functional Tricuspid Regurgitation.

BACKGROUND: Functional tricuspid regurgitation (FTR) secondary to left-sided heart disease may lead to poor quality of life and reduced long-term survival. This study evaluated clinical and functional outcomes of patients undergoing tricuspid valve (TV) repair using a rigid three-dimensional ring (Contour 3D, Medtronic) concomitant with another procedure. METHODS: From September 2011 to July 2015, 112 patients (mean age 70.9 ± 9.0 years) were enrolled at 10 centers in Europe, Israel, and the United States. Inclusion criteria were FTR ≥ moderate and/or tricuspid annular diameter (TAD) ≥ 40 mm. Echocardiography was planned before surgery and at discharge with echocardiographic and clinical follow-ups performed 6 months postoperatively. RESULTS: Three fourths (74.4%) of patients had higher than moderate TR. Mean TAD was 41.0 ± 7.3 mm; 61.7% of patients were in the New York Heart Association (NYHA) class III/IV. The most common concomitant procedure was mitral valve repair (57 patients, 53.3%). The 30-day mortality rate was 0.9% (n = 1). The mean EuroSCORE II was 8.9 ± 8.4% (median: 5.9%; interquartile range: 3.5-11.5%). The observed to expected ratio (O/E) based on the median was 0.1. Six deaths occurred during follow-up (three cardiac related). Mean implanted ring size was 30.3 ± 2.7. At 6 months, 94.4% of patients showed ≤ mild TR, and 92.0% were in NYHA class I/II (p < 0.001 vs baseline for both). Mean pressure gradient across the TV was 2.0 ± 1.1 mm Hg; leaflet coaptation length was 7.5 ± 3.3 mm. CONCLUSION: The Contour 3D annuloplasty ring used for treatment of FTR substantially reduced TR for up to 6 postoperative months with low mean pressure gradients across the TV and significant improvement in NYHA class. REGISTRATION: www.ClinicalTrials.gov, NCT01532921.

Anticoagulation following mitral valve repair.

BACKGROUND AND AIM: Anticoagulation after mitral valve repair is controversial and guidelines are not well-established. This study evaluated the association between postoperative warfarin use and complications after mitral valve repair, including bleeding and thromboembolic incidents, readmission, and mortality. METHODS: This retrospective study investigated 1097 patients who underwent elective mitral valve repair between April 2003 and March 2017, and was naïve to atrial fibrillation or prior cardiac surgery. This cohort had no other indication for or against anticoagulation. About 775 patients were placed on warfarin with international normalized ratio goal 2.5 and 322 patients were not anticoagulated. The association between anticoagulation and complications was assessed with univariate comparisons between groups and multiple logistic regression. RESULTS: Postoperative warfarin use was associated with a reduced composite of bleeding and thromboembolic complications (pulmonary embolism, TIA, stroke, pericardial effusion or cardiac tamponade, gastrointestinal bleeding, and reoperation for bleeding) with an odds ratio of 0.29 (95% confidence interval, 0.13-0.64, P = .003). There was no difference in 30-day or 6-month mortality or readmission rate between groups. Long-term survival estimates were superior in the warfarin group (10-year: 92% vs 85%; log-rank P < .001). CONCLUSIONS: Our analysis showed that postoperative warfarin use was associated with an overall reduced composite of bleeding and thromboembolic incidents and superior long-term survival. These findings suggest that anticoagulation with warfarin following mitral valve repair may be a safe and effective means for avoiding postoperative complications and that a large prospective randomized clinical trial is warranted.

Biotic elicitation as a tool to improve strawberry and raspberry extract potential on metabolic syndrome-related enzymes in vitro.

BACKGROUND: Raspberry and strawberry are high value-added food products that can contribute to human health due to the abundance of polyphenols that they contain. Polyphenols are secondary metabolites and therefore devoted to improve plant adaptation, these polyphenol profile can be induced applying different stimuli, such as certain bacteria. The aim of this study was twofold: (i) to evaluate the ability of two bacterial strains to modulate secondary metabolisms in strawberry and raspberry, and (ii) to explore the ability of plant extracts to modify enzyme activities related to metabolic syndrome. RESULTS: Total phenolic and anthocyanin content was higher in strawberries than in raspberries, despite similar antioxidant capacities. Strawberry extracts performed better on the tested enzymes, except on α-glucosidase inhibition capacity. Bacillus amyloliquefaciens stabilized the effects of extracts at different points in time, and Pseudomonas fluorescens modified plant metabolism after more inoculations (spring) in both species, improving the effects of raspberry extracts on α-glucosidase, COX1, and COX2, and of strawberry on α-amylase and COX1. CONCLUSION: It is good to include these two fruits in the diet because they improve the activity of metabolic syndrome-related enzymes. Applying either strain during plant growth modifies the bioactive profile of the plants, improving the effects of the fruit extracts on human health. © 2018 Society of Chemical Industry.

Tricuspid Valve Leaflet Repair and Augmentation for Infective Endocarditis.

Intravenous drug use has increased substantially over the past decade, with heroin abuse more than doubling. Injection drug use-related infective endocarditis hospitalizations have similarly increased over the same period. Right-sided infective endocarditis is strongly associated with intravenous drug use, and 90% of right-sided endocarditis involves the tricuspid valve. During the period of the opioid epidemic, tricuspid-related endocarditis rates have increased, while the incidence of surgery for tricuspid endocarditis has increased as much as five-fold. Within this context, optimizing surgical technique for valve repair is increasingly important. In this report, we examine the indications for tricuspid valve surgery for endocarditis, describe specific techniques for tricuspid valve leaflet repair and augmentation, and assess postoperative care and surgical outcomes after both tricuspid valve repair and replacement for infective endocarditis.

Surgical ablation of atrial fibrillation during mitral-valve surgery.

BACKGROUND: Among patients undergoing mitral-valve surgery, 30 to 50% present with atrial fibrillation, which is associated with reduced survival and increased risk of stroke. Surgical ablation of atrial fibrillation has been widely adopted, but evidence regarding its safety and effectiveness is limited. METHODS: We randomly assigned 260 patients with persistent or long-standing persistent atrial fibrillation who required mitral-valve surgery to undergo either surgical ablation (ablation group) or no ablation (control group) during the mitral-valve operation. Patients in the ablation group underwent further randomization to pulmonary-vein isolation or a biatrial maze procedure. All patients underwent closure of the left atrial appendage. The primary end point was freedom from atrial fibrillation at both 6 months and 12 months (as assessed by means of 3-day Holter monitoring). RESULTS: More patients in the ablation group than in the control group were free from atrial fibrillation at both 6 and 12 months (63.2% vs. 29.4%, P<0.001). There was no significant difference in the rate of freedom from atrial fibrillation between patients who underwent pulmonary-vein isolation and those who underwent the biatrial maze procedure (61.0% and 66.0%, respectively; P=0.60). One-year mortality was 6.8% in the ablation group and 8.7% in the control group (hazard ratio with ablation, 0.76; 95% confidence interval, 0.32 to 1.84; P=0.55). Ablation was associated with more implantations of a permanent pacemaker than was no ablation (21.5 vs. 8.1 per 100 patient-years, P=0.01). There were no significant between-group differences in major cardiac or cerebrovascular adverse events, overall serious adverse events, or hospital readmissions. CONCLUSIONS: The addition of atrial fibrillation ablation to mitral-valve surgery significantly increased the rate of freedom from atrial fibrillation at 1 year among patients with persistent or long-standing persistent atrial fibrillation, but the risk of implantation of a permanent pacemaker was also increased. (Funded by the National Institutes of Health and the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00903370.).

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.

A Systematic Review and Meta-Analysis of Outcomes Following Mitral Valve Surgery in Patients with Significant Functional Mitral Regurgitation and Left Ventricular Dysfunction.

BACKGROUND AND AIM OF THE STUDY: The surgical correction of functional mitral regurgitation (MR) remains challenging and controversial. The study aim was to systematically review the outcomes of surgical mitral valve repair (MVRpr) and mitral valve replacement (MVR) in patients with significant functional MR and left ventricular (LV) dysfunction. METHODS: A meta-analysis was performed of published data acquired from patients with moderate to severe functional MR and LV ejection fraction (LVEF) <40% who underwent surgical MVRpr or MVR. The data were meta-analyzed across studies using Bayesian hierarchical models when feasible. RESULTS: The search yielded 36 observational studies. The pooled proportion of operative mortality following MVRpr was 5% (33 studies; 2,231 patients; 95% credible interval (CrI) 4-7%), while that following MVR was 10% (10 studies; 389 patients; 95% CrI 5-18%). For patients undergoing MVRpr, pooled proportions of postoperative cerebrovascular accidents and renal failure were 2% (11 studies; 750 patients; 95% CrI 1-3%) and 9% (11 studies; 756 patients; 95% CrI 5-16%), respectively. The five-year actuarial survival rates following MVRpr across 12 studies ranged from 47% to 78% (median 66%). CONCLUSIONS: In selected patients with significant functional MR and LV dysfunction, surgical MVRpr and MVR can be performed with acceptable intermediate operative mortality risks.

Surgical approach to functional tricuspid regurgitation: should we be more aggressive?

PURPOSE OF REVIEW: Functional tricuspid regurgitation (FTR) is an important clinical entity that is encountered frequently during the operative management of left-sided heart valve disease, particularly in the setting of mitral regurgitation. Failure to recognize the importance of FTR during mitral valve surgery may result in inferior early and late outcomes because of the progression of tricuspid regurgitation and right heart failure. In this review, attention is focused on recent literature, which increasingly supports the use of corrective tricuspid valve annuloplasty, and the growing consensus that FTR or tricuspid annular dilation should be more aggressively addressed at the time of cardiac surgery. RECENT FINDINGS: The European Society of Cardiology and the European Association for Cardiothoracic Surgery (ESC/EACTS) 2012 guidelines recommend a more proactive approach to tricuspid regurgitation correction and highlight the shifting consensus toward more aggressive surgical therapy. Rigid annuloplasty rings should be used in favor of flexible bands or DeVega-style repairs. Preoperative determinants of clinical outcomes now include echocardiographic parameters of tricuspid valve tenting area, and associated right ventricular size and function. SUMMARY: Despite data demonstrating inferior outcomes in the presence of residual tricuspid regurgitation after cardiac surgery, surgical repair for FTR appears to be underutilized. Increased recognition and correction of tricuspid regurgitation at the time of surgery is increasingly supported by published guidelines, although randomized prospective data are needed to bolster current recommendations.

Mitral valve surgery: wait and see vs. early operation.

Mitral valve repair represents the optimal surgical treatment for severe degenerative mitral regurgitation. According to the current guidelines, mitral repair is indicated in the presence of symptoms and/or signs of left ventricular (LV) dysfunction. In asymptomatic patients with preserved LV function, surgery should be considered in the presence of atrial fibrillation (AF) and/or pulmonary hypertension. In asymptomatic patients with preserved LV function, normal pulmonary artery pressure, and no episodes of AF, surgical timing is still an object of debate. The controversial issue is whether, in those circumstances, a 'wait and see (watchful waiting)' approach should be followed or an 'early repair' policy should be preferred. Indeed, a randomized trial comparing the two strategies has never been performed. In the absence of evidence-based arguments definitely supporting any particular course of action, advantages, drawbacks, and requirements for both strategies will be discussed in this review on the basis of the most significant observational studies which have focused on this issue.

Does Sustained Reduction of Functional Mitral Regurgitation Impact Survival?

Functional mitral regurgitation (FMR) is associated with increased mortality and has been considered a marker for advanced heart disease, yet the value of mitral valve repair (MVr) in this population remains unclear. This study aims to evaluate the impact of reducing FMR burden through surgical MVr on survival. Patients with severe FMR who underwent MVr with an undersized, complete, rigid, annuloplasty between 2004 and 2017 were assessed (n = 201). Patients were categorized based on grade of recurrent FMR (0-4). Time-to-event Kaplan-Meier estimations of freedom from death or reoperation were performed using the log-rank test. Cox proportional hazards models evaluated all-cause mortality and reported in hazards ratios (HR) and 95% confidence intervals (CI). Patients were categorized by postoperative recurrent FMR: 45% (91/201) of patients had grade 0, 29% (58/201) grade 1, 20% (40/201) grade 2, 2% (4/201) grade 3%, and 4% (8/201) grade 4. The cumulative incidence of reoperation with death as a competing risk was higher in patients with grades ≥3 recurrent FMR compared to grades ≤2 (44.6% vs 14.6%, subhazard ratio 3.69 [95% CI, 1.17-11.6]; P = 0.026). Overall freedom from death or reoperation was superior for recurrent FMR grades ≤2 compared to grades ≥3 (log-rank P < 0.001). Increasing recurrent FMR grade was independently associated with mortality (HR 1.30 [95% CI, 1.07-1.59] P = 0.009). Reduced postoperative FMR grade resulted in an incrementally lower risk of death or reoperation after MVr. These results suggest that achieving a durable reduction in FMR burden improves long-term survival.

Sex-Based Differences in Concomitant Tricuspid Repair During Degenerative Mitral Surgery.

BACKGROUND: Women with mitral valve disease have higher rates of tricuspid regurgitation (TR) than men. Although tricuspid valve repair (TVr) decreases the progression of TR, we hypothesize that there may be sex-based differences in concomitant TVr at the time of mitral valve operations. METHODS: Adults undergoing mitral valve operation for degenerative disease with moderate or worse preoperative TR at a high-volume center from 2014 to 2023 were identified. Patients with a previous tricuspid intervention were excluded. A multivariable logistic regression identified predictors of concomitant TVr. To evaluate the clinical impact of not performing TVr, a competing risk model compared development of severe TR or valve-related reoperation by sex among patients without TVr. RESULTS: Most included patients were women (55% [n = 214 of 388]), and the median age was 73 years (quartile 1-quartile 3, 65-79 years). There was no difference in the rate of severe TR by sex (female, 28%; male, 26%; P = .63). The unadjusted rate of concomitant TVr was 57% for women and 73% for men (P < .001). Overall, women had 52% lower adjusted odds of TVr (adjusted odds ratio, 0.48; 95% CI, 0.29-0.81; P = .006), including a lower adjusted rate for moderate TR (47% [95% CI, 45%-49%] vs 66% [95% CI, 64%-69%]) and for severe TR (83% [95% CI, 81%-86] vs 92% [95% CI, 90%-93%]) Among those without TVr, 12% of women and 0% of men had severe TR or required a valve-related reoperation at 4 years (P < .001). CONCLUSIONS: Women with moderate or severe TR undergoing mitral valve operation for degenerative disease were less likely to receive concomitant TVr, severe TR was more likely to develop, or they would more likely need a valve-related reoperation. Evaluation of sex-based treatment differences is imperative to improve outcomes for women.

Evaluation of sex differences in the receipt of concomitant atrial fibrillation procedures during nonmitral cardiac surgery.

OBJECTIVE: Women are less likely to receive guideline-recommended cardiovascular care, but evaluation of sex-based disparities in cardiac surgical procedures is limited. Receipt of concomitant atrial fibrillation (AF) procedures during nonmitral cardiac surgery was compared by sex for patients with preoperative AF. METHODS: Patients with preoperative AF undergoing coronary artery bypass grafting and/or aortic valve replacement at any of the 33 hospitals in Michigan from 2014 to 2022 were included. Patients with prior cardiac surgery, transcatheter AF procedure, or emergency/salvage status were excluded. Hierarchical logistic regression identified predictors of concomitant AF procedures, account for hospital and surgeon as random effects. RESULTS: Of 5460 patients with preoperative AF undergoing nonmitral cardiac surgery, 24% (n = 1291) were women with a mean age of 71 years. Women were more likely to have paroxysmal (vs persistent) AF than men (80% vs 72%; P < .001) and had a higher mean predicted risk of mortality (5% vs 3%; P < .001). The unadjusted rate of concomitant AF procedure was 59% for women and 67% for men (P < .001). After risk adjustment, women had 26% lower adjusted odds of concomitant AF procedure than men (adjusted odds ratio, 0.74; 95% CI, 0.64-0.86; P < .001). Female sex was the risk factor associated with the lowest odds of concomitant AF procedure. CONCLUSIONS: Women are less likely to receive guideline recommended concomitant AF procedure during nonmitral surgery. Identification of barriers to concomitant AF procedure in women may improve treatment of AF.

Risk of Pacemaker Implantation After Degenerative Mitral and Concomitant Tricuspid Valve Surgery.

BACKGROUND: A recent multicenter trial showed a reduction in tricuspid regurgitation (TR) progression when tricuspid annuloplasty was performed at the time of surgery for degenerative mitral regurgitation (MR), but with a 14% pacemaker (PPM) rate. We present real-world outcomes at a high-volume center for degenerative MR surgery with/without tricuspid annuloplasty. METHODS: Patients undergoing first-time degenerative mitral surgery between 2011-2021 were identified (n=1,738). After excluding patients undergoing aortic, aortic valve, or tricuspid replacement procedures, patients were stratified into mitral surgery alone (n=1,068) versus mitral surgery plus tricuspid annuloplasty (n=417). Outcomes including operative mortality, new PPM implantation, and postoperative length of stay as well as risk-adjusted overall mortality were compared. RESULTS: Among 1,485 patients in this study, 98% underwent mitral repair. Compared to concomitant tricuspid annuloplasty patients, those undergoing mitral surgery alone were 6 years younger and had lower median STS PROM. Among concomitant tricuspid repair patients, 85% (355/417) had moderate or less preoperative TR, while 15% (61/417) had severe TR. Operative mortality was 1.4%. The incidence of new PPM implantation was 0.7% (7/1,068) in the mitral only group and 5.5% (23/417) in the concomitant tricuspid group (p<0.001). Although unadjusted cumulative survival was lower in the concomitant tricuspid group, after risk adjustment, concomitant tricuspid surgery was not associated with worse overall mortality (HR 0.80 [95% CI, 0.53-1.19], p=0.27). CONCLUSIONS: Concomitant tricuspid annuloplasty is safe, with no difference in mortality and a less than 6% PPM rate at a high-volume mitral center. These data provide real-world context for concomitant tricuspid annuloplasty.

Increasing Adoption of Left Atrial Appendage Occlusion in Isolated Coronary Artery Bypass Grafting.

BACKGROUND: Recent randomized trial data showed fewer strokes with left atrial appendage occlusion (LAAO) following cardiac surgery in patients with atrial fibrillation. We developed a quality initiative to increase LAAO adoption. METHODS: Among 11,099 patients undergoing isolated CABG between January 2019-March 2021 at 33 hospitals in Michigan, those with atrial fibrillation undergoing first-time, on-pump CABG were eligible (n=1,241). A goal LAAO rate of 75% was selected as a quality improvement target through a statewide collaborative. An interrupted time series analysis evaluated the change in LAAO rate before (January-December 2019) versus after (January 2020-March 2021) implementation. RESULTS: Implementation of the quality metric improved LAAO rate from 61% (357/581) before to 79% (520/660) after implementation (p<0.001). Compared to patients not undergoing concomitant LAAO, LAAO patients (71%, 877/1,241) were older, more frequently male, and had a lower STS-PROM (2.9±3.5% vs. 3.7±5.7%, p=0.003), while other baseline characteristics including CHA2DS2-VASc scores were similar. Mean bypass and cross-clamp times were 7 and 6 minutes longer, respectively, in the LAAO group among those who did not undergo concomitant ablation. Operative mortality, major morbidity, blood product administration, and thromboembolic events were similar between groups. Interrupted time series analysis showed a significant increase in LAAO rate after implementation (p=0.009). CONCLUSIONS: LAAO in patients with atrial fibrillation undergoing isolated CABG did not add operative risk versus isolated CABG without LAAO. A statewide quality improvement initiative was successful in increasing the rate of concomitant LAAO and could be further evaluated as a potential quality metric in cardiac surgery.

Transcatheter Left Atrial Appendage Exclusion: Preclinical and Early Clinical Results With the Laminar Device.

BACKGROUND: The Laminar device rotates and closes the left atrial appendage (LAA) using an integrated ball and lock that excludes and eliminates the LAA pouch. There is a low device surface area, minimizing the risk of peridevice leak (PDL) and device-related thrombus (DRT) formation. OBJECTIVES: This study evaluates the safety and efficacy of the Laminar LAA exclusion device in healthy animals and human subjects with nonvalvular atrial fibrillation at risk of ischemic stroke and systemic thromboembolism. METHODS: The preclinical study implanted the Laminar device into canine subjects that underwent transesophageal echocardiography (TEE) and fluoroscopic evaluation, followed by necropsy and histological assessment at 45 and 150-days post-implant. The early clinical study implanted the device in human subjects, followed to 12 months postimplantation. Procedural success was defined as device implantation in the intended location without residual LAA leak >5 mm as seen by TEE. Safety endpoints included freedom from stroke, systemic embolism, pericardial effusion, or tamponade, life-threatening/major bleeding, or death. RESULTS: The Laminar device was successfully implanted in 10 canines. In all animals at 45 days and 150 days, no PDL or DRT was found, and histological examination showed fully closed LAAs covered with neo-endocardium. The device was successfully implanted in 15 human subjects with no safety events out to 12 months postimplantation. All subjects had successful protocol-defined LAA closure without DRT at 45 days by TEE and computed tomography, which remained stable through 12 months' follow-up. CONCLUSIONS: The preclinical and early clinical results demonstrate a promising safety and efficacy profile for the Laminar LAA exclusion device.

Alfieri versus conventional repair for bileaflet mitral valve prolapse.

Objective: Mitral valve repair for bileaflet prolapse can be complex, involving multiple chords or resection. The Alfieri technique for bileaflet disease is simple but may be associated with mitral stenosis or recurrent mitral regurgitation. Outcomes of patients with bileaflet prolapse undergoing mitral valve repair using the Alfieri versus conventional chord/resection techniques were compared. Methods: Adults undergoing mitral valve repair for bileaflet prolapse for degenerative disease from 2017 to 2023 were stratified by repair technique. Outcomes including operative mortality and echocardiogram data were compared. Time to event analysis was used to characterize freedom from recurrent mitral regurgitation (moderate or greater mitral regurgitation). Results: Among 188 patients with bileaflet prolapse, 37% (70) were repaired with the Alfieri and the remaining patients were repaired with chords/resection. Compared with chords/resection, patients undergoing the Alfieri had shorter cardiopulmonary bypass and crossclamp times. Operative mortality (0% [0/70] vs 2% [2/118], P = .27) was similar between both techniques. The mean mitral gradient was low and similar for the Alfieri versus chords/resection (3 vs 3, P = .34). Development of recurrent mitral regurgitation at 2 years, incorporating the competing risk of death and mitral reintervention, was 4.3% (95% CI, 1.5%-9.3%) for the Alfieri technique and 5.8% (95% CI, 2.2%-11.8%) for chord/resection (P = .83). Conclusions: Both the Alfieri and chord/resection techniques had low rates of recurrent mitral regurgitation at 2 years. The mitral valve gradient was low and similar regardless of technique; thus, those who received the Alfieri technique did not have an increased rate of mitral stenosis. The Alfieri may be an underused technique for bileaflet prolapse.

Cardiac Reoperations in Patients With Transcatheter Aortic Bioprosthesis.

BACKGROUND: Despite the rapid adoption of transcatheter aortic valve replacement (TAVR), the frequency and clinical outcomes of reoperation after TAVR are not well-described. METHODS: Between 2011 and 2020, 1719 patients underwent a TAVR at our institution. Among these, 32 patients (2%) required a reoperation. Additionally, 16 patients who received a TAVR at another institution received a reoperation at our institution. We retrospectively reviewed these 48 patients. The median interval from TAVR to reoperation was 2.3 years. RESULTS: Primary reoperations included 37 TAVR valve explants (TAVR-explant; 77%) with surgical aortic valve replacement (SAVR), 8 mitral repairs/replacements (17%), 2 coronary artery bypass grafting procedures (4%), and 1 tricuspid valve replacement (2%). Forty-nine percent of nonaortic valve cardiac lesions were present at the time of TAVR. Furthermore, 18 TAVR-explant patients (49%) were deemed anatomically unsuitable for repeat TAVR based on the index TAVR imaging. During TAVR-explant, 6 patients (13%) with native TAVR sustained various degrees of aortic trauma. Patients with unplanned aortic repair demonstrated a smaller sinotubular junction diameter than those without unplanned repair. In contrast, no unplanned aortic repair was needed in the 14 patients with previous SAVR or the latest 20 consecutive patients. The overall in-hospital mortality was 15%, with an observed-to-expected morality ratio of 1.8. CONCLUSIONS: The clinical impact of post-TAVR reoperation remains substantial despite the lower frequency of unplanned aortic repair over time. The necessity of reoperations or unfavorable repeat TAVR anatomy appears predictable at the time of the index TAVR, and implanters must be mindful of "lifetime management" strategy during candidate selection.