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.

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.

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.

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.

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.

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.

Simultaneous in- and out-of-plane Mitral Valve Annular Force Measurements.

Mitral valve repair with annuloplasty is often favoured over total valve replacement. In order to develop and optimize new annuloplasty ring designs, it is important to study the complex biomechanical behaviour of the valve annulus and the subvalvular apparatus with simultaneous in- and out-of-plane restraining force measurements. A new flat D-shaped mitral valve annular force transducer was developed. The transducer was mounted with strain gauges to measure strain and calibrated to provide simultaneous restraining forces in- and out of the mitral annular plane. The force transducer was implanted and evaluated in an 80 kg porcine experimental model. Accumulation of out-of-plane restraining forces, creating strain in the anterior segment were 0.7 ± 0.0 N (towards apex) and an average force accumulation of 1.5 ± 0.3 N, creating strain in the commissural segments (away from apex). The accumulations of in-plane restraining forces, creating strain on the inner side of the ring were 1.7 ± 0.2 N (away from ring center). A new mitral annular force transducer was successfully developed and evaluated in vivo. The transducer was able to measure forces simultaneously in different planes. Initial indications point towards overall agreement with previous individual force measurements in- and out-of the mitral annular plane. This can provide more detailed insight into the annular force distribution, and could potentially improve the level of evidence based mitral valve repair and support the development of future mitral annuloplasty devices.

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

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

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

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

[Mitral valve interventions: Where do we stand?]. / Mitralklappeninterventionen : Wo stehen wir?

Mitral valve regurgitation (MR) with resulting heart failure is one of the most prevalent types of valvular heart disease. Currently, various approaches to catheter-based therapy of MR are already available for patients deemed to be at high-risk for surgery. Most experience has been gained with the MitraClip® system. Technological developments in the field of catheter-based treatment of MR is advancing at a rapid pace, with treatment modalities suited for patients with both primary and secondary MR. Annuloplasty is the surgical gold standard, particularly for patients with secondary MR. For catheter-based therapy of secondary MR a distinction is made between indirect and direct annuloplasty, with the latter most closely corresponding to surgical ring implantation. Catheter-based mitral valve replacement is technically feasible at present; however, experience is still limited and only few reports have been published. Technological development is markedly slower than in the field of transcatheter aortic valve replacement, predominantly owing to the far more complex structure of the mitral valve. Positive experience has already been gained with catheter-based implantation of prostheses designed for the aortic valve into degenerated mitral valve bioprostheses and failed surgical mitral annuloplasty rings (valve-in-valve and valve-in-ring implantation). Further approaches to catheter-based treatment of MR in high-risk surgical patients are expected in the future.

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

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

Parecer técnico científico e análise de custo-efetividade Mitraclip para insufciciencia mitral / Scientific technical advice and cost-effectiveness analysis mitraclip for mitral insufficiency

INTRODUÇÃO: A insuficiência mitral (IM) é caracterizada pela regurgitação sanguínea para o átrio esquerdo durante a sístole ventricular. Pode ser decorrente de anormalidades em diferentes locais do aparato valvar, tais como folhetos, ânulo, cordas tendíneas e músculos papilares. Etiologicamente, a insuficiência mitral é classificada em primária ou degenerativa quando existem anormalidades estruturais da valva e como funcional ou secundária quando a regurgitação não ocorre por problemas na valva, mas como resultado de outros problemas. Dentre as causas primárias, destacam-se a febre reumática, o prolapso valvar mitral, a endocardite infecciosa, traumas e as deformidades congênitas. As etiologias secundárias estão relacionadas à isquemia miocárdica, cardiomiopatia hipertrófica e dilatação ventricular esquerda. A IM secundária tem pior prognóstico por associar-se a outras doenças. TECNOLOGIA: O dispositivo percutâneo MitraClip® (Abbott Vascular, Menlo Park, CA) surgiu como uma possível alternativa à cirurgia convencional de plastia ou troca valvar mitral. Publicado no diário oficial em 24 de março de 2014, o dispositivo foi aprovado para utilização no Brasil pela ANVISA sob o número 25351.099555/2013-99. Nome comercial: clip delivery system ­ MitraClip system. PERGUNTA CLÍNICA: O uso do MitraClip® deve ser considerado em dois grupos distintos: 1. substituto da cirurgia aberta; 2. opção para pacientes cujo alto risco cirúrgico contraindique a cirurgia aberta. Abordaremos as evidências de acordo com as perguntas: 1. O uso do MitraClip® é eficaz, seguro e custo-efetivo em pacientes com insuficiência mitral e indicação de cirurgia de correção mitral quando comparado à cirurgia? 2. O uso do MitraClip® é eficaz, seguro e custo-efetivo em pacientes com insuficiência mitral grave e alto risco cirúrgico, considerados inoperáveis, quando comparado ao tratamento clínico padrão? ANÁLISE DA EVIDÊNCIA: Embora muitas intervenções percutâneas estejam em desenvolvimento, apenas duas encontram-se atualmente disponíveis no mercado internacional; MitraClip® e Carillon®. A MitraClip® possui uma base de evidências mais desenvolvida, embora ainda limitada, com apenas 1 ensaio clínico randomizado, o EVEREST II. DISCUSSÃO: O MitraClip® tem demonstrado boa segurança e eficácia em pacientes selecionados adequadamente através da ecocardiografia transesofágica. Porém, é necessário refinar a seleção dos pacientes, em relação a etiologia da IM, se funcional ou degenerativa, presença de hipertensão pulmonar, disfunção ventricular direita e presença de arritmias como a fibrilação atrial. Apesar dos resultados clínicos promissores, os custos e a custo-efetividade da MitraClip® limitam sua utilização. O benefício clínico é inferior ao obtido com o tratamento cirúrgico, e com um custo muito superior, sendo assim contraindicada a utilização do MitraClip® em substituição à cirurgia aberta. O custo/benefício de um procedimento como MitraClip® pode ser menos significativo em pacientes com IM funcional devido a comorbidades que limitam significativamente sua expectativa de vida. PARECER FINAL: -Recomendação forte contrária à incorporação na rotina hospitalar; -Frente a eficácia e segurança, a tecnologia pode ser utilizada em contexto de pesquisa ou ensino.

Design considerations and quantitative assessment for the development of percutaneous mitral valve stent.

Percutaneous heart valve replacement is gaining popularity, as more positive reports of satisfactory early clinical experiences are published. However this technique is mostly used for the replacement of pulmonary and aortic valves and less often for the repair and replacement of atrioventricular valves mainly due to their anatomical complexity. While the challenges posed by the complexity of the mitral annulus anatomy cannot be mitigated, it is possible to design mitral stents that could offer good anchorage and support to the valve prosthesis. This paper describes four new Nitinol based mitral valve designs with specific features intended to address migration and paravalvular leaks associated with mitral valve designs. The paper also describes maximum possible crimpability assessment of these mitral stent designs using a crimpability index formulation based on the various stent design parameters. The actual crimpability of the designs was further evaluated using finite element analysis (FEA). Furthermore, fatigue modeling and analysis was also done on these designs. One of the models was then coated with polytetrafluoroethylene (PTFE) with leaflets sutured and put to: (i) leaflet functional tests to check for proper coaptation of the leaflet and regurgitation leakages on a phantom model and (ii) anchorage test where the stented valve was deployed in an explanted pig heart. Simulations results showed that all the stents designs could be crimped to 18F without mechanical failure. Leaflet functional test results showed that the valve leaflets in the fabricated stented valve coapted properly and the regurgitation leakage being within acceptable limits. Deployment of the stented valve in the explanted heart showed that it anchors well in the mitral annulus. Based on these promising results of the one design tested, the other stent models proposed here were also considered to be promising for percutaneous replacement of mitral valves for the treatment of mitral regurgitation, by virtue of their key features as well as effective crimping. These models will be fabricated and put to all the aforementioned tests before being taken for animal trials.

Statistical assessment of normal mitral annular geometry using automated three-dimensional echocardiographic analysis.

BACKGROUND: The basis of mitral annuloplasty ring design has progressed from qualitative surgical intuition to experimental and theoretical analysis of annular geometry with quantitative imaging techniques. In this work, we present an automated three-dimensional (3D) echocardiographic image analysis method that can be used to statistically assess variability in normal mitral annular geometry to support advancement in annuloplasty ring design. METHODS: Three-dimensional patient-specific models of the mitral annulus were automatically generated from 3D echocardiographic images acquired from subjects with normal mitral valve structure and function. Geometric annular measurements including annular circumference, annular height, septolateral diameter, intercommissural width, and the annular height to intercommissural width ratio were automatically calculated. A mean 3D annular contour was computed, and principal component analysis was used to evaluate variability in normal annular shape. RESULTS: The following mean ± standard deviations were obtained from 3D echocardiographic image analysis: annular circumference, 107.0 ± 14.6 mm; annular height, 7.6 ± 2.8 mm; septolateral diameter, 28.5 ± 3.7 mm; intercommissural width, 33.0 ± 5.3 mm; and annular height to intercommissural width ratio, 22.7% ± 6.9%. Principal component analysis indicated that shape variability was primarily related to overall annular size, with more subtle variation in the skewness and height of the anterior annular peak, independent of annular diameter. CONCLUSIONS: Patient-specific 3D echocardiographic-based modeling of the human mitral valve enables statistical analysis of physiologically normal mitral annular geometry. The tool can potentially lead to the development of a new generation of annuloplasty rings that restore the diseased mitral valve annulus back to a truly normal geometry.

Why is intracardiac echocardiography helpful? Benefits, costs, and how to learn.

Current interventional procedures in structural heart disease and cardiac arrhythmias require peri-interventional echocardiographic monitoring and guidance to become as safe, expedient, and well-tolerated for patients as possible. Intracardiac echocardiography (ICE) complements and has in part replaced transoesophageal echocardiography (TEE), including real-time three-dimensional (RT-3D) imaging. The latter is still widely accepted as a method to prepare for and to guide interventional treatments. In contrast to TEE, ICE represents a purely intraprocedural guiding and imaging tool unsuitable for diagnostic purposes. Patients tolerate ICE much better, and the method does not require general anaesthesia. Accurate imaging of the particular pathology, its anatomic features, and spatial relation to the surrounding structures is critical for catheter and wire positioning, device deployment, evaluation of the result, and for ruling out complications. This review describes the peri-interventional role of ICE, outlines current limitations, and points out future implications. Two-dimensional ICE has become a suitable guiding tool for a variety of percutaneous treatments in patients who are conscious or under monitored anaesthesia care, whereas RT-3DICE is still undergoing clinical testing. Continuous TEE monitoring under general anaesthesia remains a widely accepted alternative.

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

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