Computational simulation model of transcatheter edge-to-edge mitral valve repair: a proof-of-concept study.

AIMS: As transcatheter mitral valve (MV) interventions are expanding and more device types and sizes become available, a tool supporting operators in pre-procedural planning and the clinical decision-making process is highly desirable. We sought to develop a finite element computational simulation model to predict the results of transcatheter edge-to-edge repair (TEER) interventions. METHODS AND RESULTS: We prospectively enrolled patients with secondary mitral regurgitation (MR) referred for a clinically indicated TEER. The 3D trans-oesophageal echocardiograms performed at the beginning of the procedure were used to perform the simulation. On the 3D dynamic model of the MV that was first obtained, we simulated the clip implantation using the same clip type, size, number, and implantation location that was used during the intervention. The 3D model of the MV obtained after the simulation of the clip implantation was compared with the clinical results obtained at the end of the intervention. We analysed the degree and location of residual MR and the shape and area of the diastolic MV area. We performed computational simulation on five patients. Overall, the simulated models predicted well the degree and location of the residual regurgitant orifice(s) but tended to underestimate the diastolic mitral orifice area. CONCLUSION: In this proof-of-concept study, we present preliminary results on our algorithm simulating clip implantation in five patients with functional MR. We show promising results regarding the feasibility and accuracy in terms of predicting residual MR and the need to improve the estimation of the diastolic MV area.

Transcatheter mitral valve repair for inotrope dependent cardiogenic shock - Design and rationale of the CAPITAL MINOS trial.

BACKGROUND: Functional mitral regurgitation (MR) is an important clinical consideration in patients with heart failure. Transcatheter edge-to-edge repair (TEER) has emerged as a useful therapeutic tool for patients with chronic heart failure, however the role of TEER in patients with cardiogenic shock (CS) and MR has not yet been studied in a randomized trial. The Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock (CAPITAL MINOS) trial was therefore designed to determine if TEER improves clinical outcomes in the CS population. METHODS AND DESIGN: The CAPITAL MINOS trial is an open-label, multi-center randomized clinical trial comparing TEER to medical therapy in patients with CS and MR. A total of 144 patients with Society for Cardiovascular Angiography and Interventions (SCAI) class C or D CS and at least 3+ MR will be randomized in a 1:1 ratio to TEER or medical therapy alone. The primary outcome will be a composite of in-hospital all-cause mortality, cardiac transplantation, implantation of durable left ventricular assist device, or discharge on palliative inotropic therapy. Patients will be followed for the duration of their index hospitalization for the primary outcome. Secondary outcomes include 6 month mortality. IMPLICATIONS: The CAPITAL MINOS trial will determine whether TEER improves outcomes in patients with CS and MR and will be an important step in optimizing treatment for this high-risk patient population.

Impact of sex on outcomes after percutaneous repair of functional mitral valve regurgitation.

BACKGROUND: The role of percutaneous repair of functional mitral regurgitation (MR) is evolving. Left ventricle remodeling is known to be different between men and women; however, outcomes following percutaneous repair of functional MR have not considered the impact of sex. METHODS: Between 2012 and 2018, 175 patients underwent percutaneous repair of functional MR with the Mitra Clip NT/NTR (Abbott) at our institution. Patients were assessed in a dedicated clinic with a follow-up that averaged 0.7 ± 1.2 years and extended to 5.7 years. RESULTS: Men had a larger body surface area than women (p < .001), and were more likely than women to have diabetes preoperatively (p = .02). There were no deaths or instances of single leaflet detachment. Immediate postprocedure MR was ≤2+ in 158 (90%) with a mean trans-mitral valve repair gradient of 3.4 ± 1.0 and 3.5 ± 2.1 mmHg, respectively for women and men (p = .8). One- and 2-year freedom from MR ≥3+ was 86.0 ± 3.5% and 77.6 ± 5.1%, respectively. After adjusting for differences between male and female patients, women were more likely to have recurrent MR ≥3+ (hazard ratio, 4.7; 95% confidence interval, 1.2-18.4; p = .03). Upon adjusted analysis, there was also no association between gender and survival (p = .2). One- and 2-year survival was 69.8 ± 4.3% and 54.3 ± 5.5%, respectively. CONCLUSION: Women are more likely to have recurrent severe MR after percutaneous repair of functional MR. The mechanism for this remains undetermined.

Transcatheter Mitral Valve Repair in Cardiogenic Shock and Mitral Regurgitation: A Patient-Level, Multicenter Analysis.

OBJECTIVES: The aim of this study was to evaluate the outcome of transcatheter mitral valve repair (TMVr) in patients with cardiogenic shock and significant mitral regurgitation (MR). BACKGROUND: Patients in cardiogenic shock with severe MR have a poor prognosis in the setting of conventional medical therapy. Because of its favorable safety profile, TMVr is being increasingly used as an acute therapy in this population, though its efficacy remains unknown. METHODS: A multicenter, collaborative, patient-level analysis was conducted. Patients with cardiogenic shock and moderate to severe (3+) or severe (4+) MR who were not surgical candidates were treated with TMVr. The primary outcome was in-hospital mortality. Secondary outcomes included 90-day mortality, heart failure (HF) hospitalization, and the combined event rate of 90-day mortality and HF hospitalization following dichotomization by TMVr device success. RESULTS: Between January 2011 and February 2019, 141 patients across 14 institutions met the inclusion criteria. In-hospital mortality occurred in 22 patients (15.6%), at 90 days in 38 patients (29.5%), and at one year in 55 patients (42.6%). Median length of hospital stay following TMVr was 10 days (interquartile range: 6 to 20 days). HF hospitalization occurred in 26 patients (18.4%) at a median of 73 days (interquartile range: 26 to 546 days). When stratified by TMVr procedural results, successful TMVr reduced rates of in-hospital mortality (hazard ratio [HR]: 0.36; 95% confidence interval [CI]: 0.13 to 0.98; p = 0.04), 90-day mortality (HR: 0.36; 95% CI: 0.16 to 0.78; p = 0.01), and the composite of 90-day mortality and HF hospitalization (HR: 0.41; 95% CI: 0.19 to 0.90; p = 0.03). CONCLUSIONS: TMVr may improve short- and intermediate-term mortality in high-risk patients with cardiogenic shock and moderate to severe MR. Randomized studies are needed to definitively establish MR as a therapeutic target in patients with cardiogenic shock.

Dynamic Blood-Brain Barrier Regulation in Mild Traumatic Brain Injury.

Whereas the diagnosis of moderate and severe traumatic brain injury (TBI) is readily visible on current medical imaging paradigms (magnetic resonance imaging [MRI] and computed tomography [CT] scanning), a far greater challenge is associated with the diagnosis and subsequent management of mild TBI (mTBI), especially concussion which, by definition, is characterized by a normal CT. To investigate whether the integrity of the blood-brain barrier (BBB) is altered in a high-risk population for concussions, we studied professional mixed martial arts (MMA) fighters and adolescent rugby players. Additionally, we performed the linear regression between the BBB disruption defined by increased gadolinium contrast extravasation on dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) on MRI and multiple biomechanical parameters indicating the severity of impacts recorded using instrumented mouthguards in professional MMA fighters. MMA fighters were examined pre-fight for a baseline and again within 120 h post-competitive fight, whereas rugby players were examined pre-season and again post-season or post-match in a subset of cases. DCE-MRI, serological analysis of BBB biomarkers, and an analysis of instrumented mouthguard data, was performed. Here, we provide pilot data that demonstrate disruption of the BBB in both professional MMA fighters and rugby players, dependent on the level of exposure. Our data suggest that biomechanical forces in professional MMA and adolescent rugby can lead to BBB disruption. These changes on imaging may serve as a biomarker of exposure of the brain to repetitive subconcussive forces and mTBI.

Clinical Diagnostic Tests versus Medial Branch Blocks for Adults with Persisting Cervical Zygapophyseal Joint Pain: A Systematic Review and Meta-Analysis.

Purpose: A systematic review and meta-analysis were performed to identify clinical tests for diagnosing cervical zygapophyseal joint pain (CZP) and to determine their diagnostic accuracy. Method: A search strategy was carried out to find relevant evidence published in CINAHL, Embase, MEDLINE, and PEDro from 1980 to January 1, 2015, pertaining to the clinical diagnosis of CZP. Quality assessment was completed using the Quality Assessment of Diagnostic Accuracy Studies-2. Results were analyzed to pool sensitivity and specificity and clarify diagnostic value. Results: Seven articles (n=463) were included for data synthesis and review. Intersegmental mobility tests were found to have the highest diagnostic accuracy, with pooled sensitivity of 0.91 (95% CI: 0.85, 0.94) and specificity of 0.74 (95% CI: 0.65, 0.81). The pooled sensitivity for mechanical sensitivity (palpation) was 0.88 (95% CI: 0.78, 0.95), and specificity was 0.61 (95% CI: 0.50, 0.71). Conclusion: Limited studies are available that discuss the clinical diagnosis of CZP, and significant heterogeneity is present in the available data. In this review, intersegmental mobility tests were found to be the most accurate. Clustering of tests, agreement on a reference standard, and further exploration of CZP referral patterns are recommended.

Objectif : analyse systématique et méta-analyse afin de déterminer les tests cliniques nécessaires pour diagnostiquer des douleurs des articulations zygapophysaires cervicales (AZC) et en établir l'exactitude diagnostique. Méthodologie : les chercheurs ont adopté une stratégie de recherche pour extraire les données probantes pertinentes publiées dans CINAHL, Embase, Medline et PEDRo entre 1980 et le 1er janvier 2015, à l'égard du diagnostic clinique d'AZC. Ils en ont évalué la qualité au moyen des études d'exactitude diagnostique des évaluations de la qualité­2. Ils ont analysé les résultats pour en regrouper la sensibilité et la spécificité ainsi que pour en confirmer la valeur diagnostique. Résultats : les auteurs ont conservé sept articles (n=463) pour la synthèse et l'analyse des données. Ils ont découvert que les tests de mobilité intersegmentaire possédaient la plus grande précision diagnostique. En effet, la sensibilité groupée s'établissait à 0,91 (IC à 95% : 0,85, 0,94) et la spécificité, à 0,74 (IC à 95 % : 0,65, 0,81). La sensibilité mécanique groupée (palpation) était de 0,88 (IC à 95 % : 0,78, 0,95), et la spécificité, à 0,61 (IC à 95 % : 0,50, 0,71). Conclusion : peu d'études portent sur le diagnostic clinique des AZC, et les données disponibles sont très hétérogènes. Dans la présente analyse, les tests de mobilité intersegmentaire étaient les plus précis. Il est recommandé de regrouper les tests, de s'entendre sur une norme de référence et d'approfondir l'examen des profils d'orientation des AZC vers d'autres spécialistes.

How Does Mitral Valve Repair Fail in Patients With Prolapse?-Insights From Longitudinal Echocardiographic Follow-Up.

BACKGROUND: Repair of mitral regurgitation (MR) caused by prolapse has been well validated. Although favorable early and late results after repair have been reported, few data are available that mechanistically describe how a mitral repair fails beyond the mere need for mitral valve reoperation. We therefore sought to determine the modes of valve repair failure in patients who underwent surgical correction of MR caused by prolapse. METHODS: Between 2001 and 2015, 855 patients underwent repair of MR caused by prolapse. Patients were a mean age of 63.7 ± 12.7 years, and 380 (44%) had bileaflet prolapse. The overall repair rate was 97.2%. These patients were monitored as part of a cohort initiative and underwent serial clinical and echocardiographic assessments at 1, 3 to 6, and 12 months after the operation. Beyond the first year of the MR repair, patients were assessed by echocardiography every 1 to 2 years or when clinically indicated. Clinical and echocardiographic follow-up averaged 4.3 ± 3.5 years. RESULTS: Freedom from recurrent MR of 2+ or higher was 92.4% ± 1.3% at 5 years and 86.6% ± 2.4% at 10 years. Overall, recurrent MR of 2+ or higher developed in 49 patients (5.7%) at a mean of 3.1 ± 2.5 years after the repair, of whom 14 (1.6%) had recurrent MR of 3+ or 4+. Among patients with bileaflet prolapse, recurrent MR of 2+ or higher was observed in 24, of whom 9 had 3+ or 4+ MR., The development of recurrent MR of 2+ or higher was categorized as prolapse in 6 and nonprolapse in 43. Severe mitral stenosis occurred in 3 patients at 8.2 years after the MR repair. Mitral reoperation was ultimately performed in 21 patients. Patients who had recurrent MR 2+ or higher within the first year after the operation were more likely to undergo a subsequent mitral valve reoperation (incident rate ratio, 5.2 ± 2.9; p = 0.003), although no association between recurrent MR and reoperation was observed after the first year. CONCLUSIONS: Severe MR after repair is rare, although some may have recurrent moderate MR. Patients who required a subsequent mitral valve reoperation were most likely to have recurrent MR of 2+ or higher within the first year after the operation.

Aortic root geometry in bicuspid aortic insufficiency versus stenosis: implications for valve repair.

OBJECTIVES: The contribution of aortic annular and root disease in bicuspid aortic valve (BAV) insufficiency remains unclear. We compared aortic root geometry between BAV stenosis and aortic insufficiency (AI), before and after repair. METHODS: Patients presenting for surgery for BAV insufficiency (n = 58) were compared with patients with BAV stenosis (n = 58). Clinical and transoesophageal echocardiographic data were collected, including end-diastolic diameters of the ventriculo-aortic junction (VAJ), aortic root, sinotubular junction (STJ) and ascending aorta (AA). RESULTS: AI patients were younger and more likely to be male compared with aortic stenosis (AS) patients. VAJ, aortic root and STJ diameters were significantly larger in AI compared with AS patients (30 ± 0.5 vs 25 ± 0.4 mm, P < 0.001; 41 ± 0.8 vs 34 ± 0.6 mm, P < 0.001; 36 ± 0.9 vs 30 ± 0.6 mm, P < 0.001, respectively). Following multivariable adjustment for age, sex, body surface area and ascending aortic diameter, these diameters remained larger in AI patients with a mean difference of 3, 6 and 4 mm, respectively (all P < 0.001). Mean AA diameter in the AI group was similar to the AS group (37 ± 1.0 vs 34 ± 0.8 mm, P = 0.06). Forty (69%) AI patients had BAV repair with a mean reduction in VAJ and STJ diameters of 5 and 9 mm compared with prerepair (P < 0.0001). CONCLUSIONS: Despite the absence of aortic aneurysms, aortic annulus and root dimensions are significantly larger in patients with BAV insufficiency compared with stenosis. Alterations in aortic root geometry contribute to the pathophysiology of BAV insufficiency and require correction for a successful repair.

Mitral valve repair in acquired dextrocardia.

Surgical correction of valvular heart disease in patients with dextrocardia is extremely rare. We report a surgical case of mitral valve repair in a patient with acquired dextrocardia. Successful mitral valve repair was performed through a right lateral thoracotomy. We describe our surgical strategy and summarize the literature.