Open Mitral Valve Surgery Research Articles

Comparative study of total thoracoscopic mitral valve surgery and traditional open mitral valve surgery :propensity score matching study

Background: Conventional median open mitral valve replacement surgery usually requires a 20-30cm size incision to ensure adequate visual exposure. So, while we complete the valve replacement, it also brings about a series of problems. The appearance of TV thoracoscope changes the exposure of the surgical field. Because the microscopic field is enlarged, it not only makes the surgical vision clearer, but also greatly shortens the incision, reduces bleeding, and conceals the incision, minimizing the trauma and shortening the postoperative recovery time, which is in line with the concept of modern health. Aim: All technological innovation is controversial in the early stage, and it is such debate that can promote the progress and development of technology.This study was conducted in the context of this debate to summarize the experience of Total thoracoscopic mitral valve surgery in our center.Total thoracoscopic mitral valve replacement surgery and traditional median incision mitral valve replacement surgery were compared by the propensity score matching method.Evaluate its safety and merits. Methods: From January 2018 to December 2020, a total of 139 patients in the thoracoscopic group were eligible in the cardiothoracic surgery department of our hospital, and 1066 cases of traditional median sternotomy mitral valve replacement. After propensity score matching, 125 patients were selected in the thoracoscopic group, among 1066 patients with median incision MVR, 1:1 matched to 125, as the control group in the thoracoscopic group. Results: The results showed that the mean operative time in the thoracoscopic MVR group was significantly longer than that in the control group (185.73 ± 43.04 vs. 164.58 ± 40.28, p=0.0016). Similarly, both the mean CPB time and aortic block time were significantly longer than those in the control group (108.37±30.57min vs. 79.18±17.65min, p <0.0001; 66.59±29.63min vs. 45.09±19.68min, p <0.0001. Moreover, the proportion of patients with CPB greater than 120min and aortic block greater than 90min was significantly higher than the control group (24.1% vs. 3.2%, p <0.0001,14.4% vs. 2.4%, p=0.0237). In addition, there was no significant difference in the mean ICU observation time between the two groups (49.35±34.51h vs. 48.72±25.89h, p=0. 8792). Differently, the mean endotracheal intubation time was significantly lower in the thoracoscopic MVR group compared to the control group (18.52±6.07h vs. 25.45±14.18h, p=0.0032). Similarly, the length of stay in the thoracoscopic group was 9.13 ± 4.58 days, which was significantly lower than 11.12 ± 5.76 days in the control group (p=0.0004). There was no significant difference in the postoperative hemoglobin concentration or platelet count between the two groups of MVR patients. Mean intraoperative bleeding volume in the thoracoscopic MVR group was significantly less than that in the control group (158.37±100.91ml vs.250.74 ± 81.34, P <0.0001). Similarly, the mean postoperative discharge in the thoracoscopic MVR group was significantly than in the control group (428.39±361.38ml vs. 514.07 ± 347.92ml, p=0.0383). For patients with postoperative blood products, there were 37 (29.6%) in the thoracoscopic group and 33 (26.4%) in the control group. There was no significant difference between the two groups. Similarly, there was no significant difference in the mean total hospital costs between the two groups. Conclusion: This study shows that it has feasibility and safety for total thoracoscopic mitral valve replacement for mitral valve lesions, which can reduce the time and stay of the hospital compared with conventional direct surgery, and obtain good minimally invasive and cosmetic effect, and lay a theoretical and clinical foundation for the application of thoracoscopic technology in cardiac surgery, which has important scientific significance.

Are severe mitral annular calcification still a contraindication to open surgery?

Abstract Background Mitral annular calcifications are considered a contraindication to open mitral valve repair/replacement, being associated with a significant risk of rupture of the atrioventricular groove or prosthesis detachment/paraprosthetic leak. Recently a scoring system has been proposed, to quantify the severity of MAC and predict the success of transcatheter valve in MAC implantation. Objective We present a series of consecutive patients with MAC undergoing sugical mitral valve replacement in recent years. Patients and methods 82 consecutive patients with MAC underwent open surgical correction from January 2019 at our centre. This was a complex cohort of patients with a high surgical risk profile (STS 5.3±3.2). The degree of MAC was moderate in 60 and severe in 22. Annular decalcification was required in 16 patients, and patch reconstruction of the AV groove in 4. The main predictor of the need for annular decalcification and reconstruction was the depth of calcium infiltration in the ventricular wall at CT. At intraoperative TEE only one patient had a significant paraprosthetic leak, that was repaired during a second short period of aortic cross-clamping. 30 days mortality was 1.2% (one patient), and 87% of patients were alive and well at one year. Comment The presence of significant mitral annular calcificaion per se should not be considered a contraindication to open mitral valve surgery. The depth of the calcifications in the ventricular wall, as measured at CT 3D multiplanar reconstructions is the best predictor of the need to decalcify/reconstruct the AV groove. Detailed imaging analysis is crucial for the success of the procedure. Funding Acknowledgement Type of funding sources: None.

Mitral valve surgery after failed MitraClip-Operation for the inoperable?

Percutaneous edge-to-edge mitral valve repair technique (MitraClip) is a widely used treatment for mitral regurgitation (MR) in patients assessed with high surgical risk or inoperability. Only limited experiences with this highest-risk patient population exist. Procedural failure for MitraClip or recurrent MR is a strong predictor of 1-year mortality. Open mitral valve surgery constitutes the last bailout for patients within this cohort. This retrospective single-center cohort study analyzed 17 mitral valve surgery patients after failed MitraClip. We, therefore, analyzed a high-risk patient population (EuroSCOREII = 10 ± 2.0) with persistent mitral valve regurgitation, which was mainly caused by detachment or dislocation of the MitraClip. Symptomatic patients with failed MitraClip need a convenient operation (mean time to mitral valve surgery = 23 ± 44 days). The patient's collective showed many complex reoperations with the need for concomitant surgery. Considering the high-risk patient population, we showed an average 30-day all-cause mortality (18%, n = 3) accompanied by typical postoperative complications related to prolonged mechanical ventilation (44 ± 48 h) and ICU stay (11 ± 11 days), reflecting high-risk patients. Further, excellent valve-related outcomes were shown regarding adverse cardiac events (valve-related mortality 6%, n = 1) and postoperative echocardiographic results (moderate or severe paravalvular leak 6%, n = 1). Failure of MitraClip represents a challenging situation limited by high-risk profiles of patients and limits the possibility of surgical valve repair, shown by a high rate of mitral valve replacement (94%, n = 16). Secondary surgery was associated with moderate 30-day and postdischarge outcomes. Therefore, a careful evaluation of patients undergoing MitraClip is of paramount importance.

Comparison of Minimally Invasive Mitral Valve Surgery vs Open Mitral Valve Replacement

Objective: To establish the advantages of invasive mitral valve surgery over open heart mitral valve surgery in treating patients with mitral valve pathologies. Material and Methods: A literature search was done on PubMed, google scholar, and Embase using search terms like open ‘invasive mitral valve surgery’, ‘mitral clip’, ‘sternotomy’, and ‘annuloplasty.” The time limit was set to 5 years ago and the language set to English. After searching, a quick screening of the title and abstract was done for relevance. The selected papers were then used in this review. Results: The minimally invasive mitral valve surgery was shown to have significantly greater survival rates across all post-surgical time frames as well as lower short-term mortality rates. Mini MVS was also shown to be more effective in treating infective endocarditis and is a highly impractical operation for patients with left ventricular dysfunction or other cardiomyopathies. The Minimally Invasive Mitral valve surgery (Mini MVS) proved to cause fewer mortalities and clearly showed a lower number of complications; the complications that exist are highly preventable. In addition, the mini MVS is more effective in treating patients with mitral regurgitation. Conclusion: This review confirms that employing the minimally invasive MVS procedure for patients with mitral valve pathologies is more effective than the standard open heart MVS in terms of post-surgery mortalities and hospital stay times. It is also more effective in treating patients with preexisting cardiomyopathies. However, sufficient training should be done to prevent complications from arising. The mitraliclp device should be further developed to prevent complications that arise due to the clip attachment

Mitral valve surgery after a failed MitraClip procedure.

Among patients undergoing transcatheter mitral valve repair with the MitraClip device, a relevant proportion (2-6%) requires open mitral valve surgery within 1 year after unsuccessful clip implantation. The goal of this review is to pool data from different reports to provide a comprehensive overview of mitral valve surgery outcomes after the MitraClip procedure and estimate in-hospital and follow-up mortality. All published clinical studies reporting on surgical intervention for a failed MitraClip procedure were evaluated for inclusion in this meta-analysis. The primary study outcome was in-hospital mortality. Secondary outcomes were in-hospital adverse events and follow-up mortality. Pooled estimate rates and 95% confidence intervals (CIs) of study outcomes were calculated using a DerSimionian-Laird binary random-effects model. To assess heterogeneity across studies, we used the Cochrane Q statistic to compute I2 values. Overall, 20 reports were included, comprising 172 patients. Mean age was 70.5 years (95% CI 67.2-73.7 years). The underlying mitral valve disease was functional mitral regurgitation in 50% and degenerative mitral regurgitation in 49% of cases. The indication for surgery was persistent or recurrent mitral regurgitation (grade >2) in 93% of patients, whereas 6% of patients presented with mitral stenosis. At the time of the operation, 80% of patients presented in New York Heart Association functional class III-IV. Despite favourable intraoperative results, in-hospital mortality was 15%. The rate of periprocedural cerebrovascular accidents was 6%. At a mean follow-up of 12 months, all-cause death was 26.5%. Mitral valve replacement was most commonly required because the possibility of valve repair was jeopardized, likely due to severe valve injury after clip implantation. Surgical intervention after failed transcatheter mitral valve intervention is burdened by high in-hospital and 1-year mortality, which reflects reflecting the high-risk baseline profile of the patients. Mitral valve replacement is usually required due to leaflet injury.

Prognostic factors influencing prolonged ventilation after open mitral valve surgery

Objective: To determine prognostic factors influencing prolonged ventilation after surgery in our hospital. Method: Seventy-five patients fulfilled inclusion criteria were included in this retrospective cross-sectional study. Prognostic factors analyzed were age, chronic pulmonary disease, heart failure (NYHA class function), left ventricular (LV) dysfunction (based on ejection fraction), recent myocardial infarction, pulmonary hypertension (PH), duration of cardiopulmonary bypass (CPB), ischemic time and aorta clamp time, which were analyzed in relation to prolonged ventilation after open mitral valve surgery. Results: Subjects were 75 patients aged between 19 and 62 years old (mean 39.76, SD 11.44) whom underwent open mitral valve repair or replacement surgery. Twenty-three patients (30.67%) had prolonged ventilation (≥24 hours) after surgery. Bivariate analysis showed there were no significant correlation between age, heart failure, PH and LV dysfunction. There are different with statistically significance between groups (p<0.05). Conclusions: In this study, almost one-third of patients had prolonged ventilation after surgery. Factors influencing this morbidity were the duration of ischemic time, aorta clamp time and CPB. Age, heart failure, LV dysfunction and PH were not statistically related to the prolonged ventilation event.

P3678Pulmonary artery ablation during open mitral valve surgery for pulmonary artery hypertension: a prospective randomized study

Abstract Purpose Recent investigations of pulmonary artery (PA) ablation into the treatment of idiopathic pulmonary artery hypertension (PAH) have suggested improvement of functional capacity, and hemodynamics. We investigated the impact of PA ablation in patients with PAH due to left heart disease (Dana Point, 2008) scheduled for open-heart mitral valve surgery. Methods Fifty patients aged 52±10 with mitral valve disease complicated severe PAH (mean PAP >40mm Hg) were randomly assigned to mitral valve surgery with or without PA ablation procedure. Eligible criteria: positive reactive test with nitric oxide inhalation (decrease of mean PAP more than 10 mm Hg without decrease of cardiac output). There were no between group differences in preoperative characteristics. Surgical procedure After bypass is establishedthe fibrous fold of pericardiumand the ligamentum arteriosum are dissected out, and the branches of the right and left pulmonary artery are mobilized well out into the hilum of the lungs bilaterally. PA ablation was performed epicardially at the bifurcation of the main PA, and 10 mm distal to the right and left PA's using AtriCure Isolator®multifunctional pen. Serial assessment of echocardiography, right heart catheterization (catheter Swan-Ganz), and 6-min walk test (6MWT) were performed during hospital stay. The primary endpoints were the change of meanpulmonary artery pressure (PAP)and 6MWT. The secondary endpoints were hospital mortality, freedom from PADN-related complication: PA perforation, PA dissection, and PA thrombosis (MDCT assessment). Results There were no early deaths. No procedure-related complications were observed. On first day after surgery patients from ablation group showed significant reduction of mean PAP (from 50.6±5.3to 34.6±9.9 mm Hg, p<0.001), and significant improvement of 6MWT at discharge (from 229±34 m to 475±21 m, p<0.001). On first day after surgery patients from control group also showed significant reduction of mean PAP (from 51.3±6.3to 47.2±8.5 mm Hg, p=0.011), and significant improvement of 6MWT at discharge (from 249±32 m to 335±18 m, p<0.001). Nevertheless, there was significant between group difference in mean PAP on first day after surgery (34.6±9.9 mm Hg, vs 47.2±8.5 mm Hg, p=0.005). Moreover there was significant differences in 6MWT at discharge (475±21 m vs 335±18 m, p=0.002) with benefit to ablation group. Epicardial pulmonary artery ablation Conclusions We report for the first time the effect and superiority of PA ablation on functional capacity and hemodynamics in patients with mitral valve disease complicated PAH. Epicardial PA ablation for the treatment PAH can be effectively and safely performed during open heart surgery. Acknowledgement/Funding None

Practice Pattern Variation in the Use of Transesophageal Echocardiography for Open Valve Cardiac Surgery

The authors sought to assess for the presence of practice variation in the use of intraoperative transesophageal echocardiography (TEE) for open cardiac valve surgery. This study was a retrospective cohort analysis. The administrative claims data used for this investigation were multi-institutional and a representative sample of commercially insured patients in the United States between 2010 and 2015. The cohort consisted of adult patients, aged 18 years or older, undergoing open mitral valve (MV) or aortic valve (AV) surgery. This was an observational analysis without interventions. Of 19,386 valve surgeries, 12,313 (64%) underwent AV replacement, 6,192 (32%) underwent MV repair or replacement, and 881 (<5%) underwent both MV and AV surgery. The overall rate of intraoperative TEE was 82% (95% confidence interval [CI]: 81%-82%), less frequently observed in AV procedures compared to MV or combined MV-AV procedures (80% v 85%, p < 0.001). Rates of intraoperative TEE claims varied markedly across U.S. states. After adjustment, the relative odds of an intraoperative TEE claim ranged across states from 0.26 (Louisiana, 95% CI: 0.18-0.36; p < 0.001) to 2.10 (North Carolina, 95% CI: 1.57-2.82; p < 0.001). Among adult patients undergoing open AV or MV surgery in the United States, 82% had a claim for an intraoperative TEE with marked variability across U.S. states. Increasing adherence to intraoperative TEE guidelines for valve surgery may represent an unrecognized opportunity to improve the quality of cardiac surgical care.

6-Minute walk test predicts prolonged hospitalization in patients undergoing transcatheter mitral valve repair by MitraClip.

The 6-minute walk test (6MWT) is a simple functional test that can predict exercise capacity and is widely employed to assess treatment outcomes. Although mortality with transcatheter mitral valve repair (TMVr) using the MitraClip (Abbott Vascular, Menlo Park, CA) is significantly less than for open mitral valve surgery in high-risk patients, identifying which patient will benefit the most from TMVr remains a concern. There are limited prognostic metrics guiding patient selection and, no studies have reported relationship between prolonged hospitalization and 6MWT. This study aimed to determine if the 6MWT can predict prolonged hospitalization in patients undergoing TMVr by MitraClip. We retrospectively reviewed 162 patients undergoing 6MWT before TMVr. Patients were divided into three groups according to the 6MWT distance (6MWTD) using the median (6MWTD ≥219 m, 6MWTD <219 m, and Unable to Walk). Multivariate logistic regression model was applied to select the demographic characteristics that were associated with the prolonged hospitalization defined as total length of stay ≥4 days in the study. We found that 6MWT (odds ratio 3.64, 95% confidence interval 2.03-6.52, P < 0.001) was independently associated with prolonged hospitalization after adjustment in multivariate analysis. Area under the curve of 6MWT for predicting prolonged hospitalization was 0.79 (95% confidence interval 0.72-0.85). Our study demonstrates that 6MWT was independently associated with prolonged hospitalization in patients with TMVr, and has a good discriminatory performance for predicting prolonged hospitalization.

OP-316 - Evaluation of Patient Factors Effecting the Ratio Converting to Synus Rythm by Cryoablation Technique in Open Mitral Valve Surgery

OP-316 - Evaluation of Patient Factors Effecting the Ratio Converting to Synus Rythm by Cryoablation Technique in Open Mitral Valve Surgery

Myocardial Protection in Mitral Valve Surgery: Comparison Between Minimally Invasive Approach and Standard Sternotomy

To compare antegrade and retrograde cardioplegia administration in minimally invasive mitral valve surgery (MIMS) and open mitral valve surgery (OMS) for myocardial protection. Retrospective study. Tertiary care university hospital. The study comprised 118 patients undergoing MIMS and 118 patients undergoing OMS. The data of patients admitted for MIMS from 2006 to 2010 were reviewed. Patients undergoing isolated elective OMS from 2004 to 2006 were used as a control group. Cardioplegia in the MIMS group was delivered via the distal port of the endoaortic clamp and an endovascular coronary sinus catheter positioned using echographic and fluoroscopic guidance. Antegrade and retrograde cardioplegia were used in OMS. Data regarding myocardial infarction (MI) (creatine kinase [CK]-MB, troponin T, electrocardiography); myocardial function; and hemodynamic stability were collected. There was no difference in the perioperative MI incidence between both groups (1 in each group, p = 0.96). No statistically significant difference was found for maximal CK-MB (35.9 µg/L [25.1-50.1] v 37.9 µg/L [28.6-50.9]; p = 0.31) or the number of patients with CK-MB levels >50 µg/L (29 v 33; p = 0.55) or CK-MB >100 µg/L (3 v 4; p = 0.70) between the OMS and MIMS groups. However, maximum troponin T levels in the MIMS group were significantly lower (0.47 µg/L [0.32-0.79] v 0.65 µg/L [0.45-0.94]; p = 0.0007). No difference in the incidence of difficult weaning from bypass and intra-aortic balloon pump use between the MIMS and OMS groups was found. Antegrade and retrograde cardioplegia administration during MIMS and OMS provided comparable myocardial protection.

Single centre experience with transapical transcatheter mitral valve implantation.

A transcatheter heart valve technique can be used in failed mitral valve repairs with annuloplasty rings, deterioriated bioprostheses and in mitral annular calcification, all serving as 'docking stations' for balloon-expandable valves. Specially designed transcatheter mitral valve platforms are used in ongoing studies for native mitral valve regurgitation. We present our single centre experience with transcatheter mitral valve implantation-transapical approach procedures in eleven patients. Eleven patients were treated between 2011 and 2016. They had severe mitral regurgitation due to either failed repair annuloplasty rings (N = 6), failed bioprostheses (N = 2) or in the native valve (N = 3), all at high risk for open mitral valve surgery. Three different types of transcatheter valves were used: (1) the SAPIEN XT/SAPIEN 3, (2) the Lotus valve and (3) a Tendyne transcatheter mitral valve. Computed tomography reconstruction, echocardiography, 3D printing and bench tests were done in the preoperative evaluation and procedural planning. Transapical approach access was performed via a left minithoracotomy. Implantation success was 100% with no left ventricular outflow tract obstruction. Good haemodynamics and improved New York Heart Association class were demonstrated in all patients. One patient died before 30 days due to sepsis. One patient had a valve thrombosis when switching from Coumadin to new oral anticoagulant and had a second valve implanted into the first one as a 'valve-in-valve' procedure. The transapical approach is a safe and straight forward procedure for accessing the mitral valve. 'Transcatheter aortic valve implantation' prostheses may be used in redo surgery due to an already sufficient 'docking station'. These specially designed new prostheses may be beneficial for addressing mitral valve regurgitation, but are still under evaluation. Anticoagulation is mandatory.

Surgical mitral valve intervention following a failed MitraClip procedure.

The MitraClip procedure has shown promising results in patients with high surgical risk. However, data concerning outcomes of open mitral valve surgery for failed MitraClip procedures are sparse. In a retrospective clinical investigation, baseline characteristics, intraoperative and histopathological findings, surgical indications and results of patients who required surgery after a failed MitraClip procedure were collected. Between March 2010 and May 2016, 25 patients presented at our department with severe mitral valve regurgitation following a failed MitraClip procedure. Leaflet destruction or severe adhesions between leaflets and the implanted clip were the commonest intraoperative findings. Upon surgery, the mitral valve was either repaired (n=5, 20%) or replaced (n=20, 80%) with a biological prosthesis. Four patients who had presented in cardiogenic shock prior to the operation died within the first 30 days. In the majority of cases, mitral valve replacement is preferred over repair due to severe leaflet damage following the MitraClip procedure. Only those patients who present in cardiogenic shock are at extremely high risk for in-hospital mortality.

The minimally invasive MitraClip™ procedure for mitral regurgitation under general anaesthesia: immediate effects on the pulmonary circulation and right ventricular function.

A relatively new minimally invasive cardiological procedure, called the MitraClip(™), does not require sternotomy and may have a number of advantages compared with open mitral valve surgery, but its acute impact on the pulmonary circulation and right ventricular function during general anaesthesia is unclear. We prospectively assessed the effects of the MitraClip procedure in 81 patients with or without pulmonary hypertension (defined as mean pulmonary artery pressure > 25 mmHg), who were anaesthetised using fentanyl (5 μg.kg(-1)), etomidate (0.2-0.3 mg.kg(-1)), rocuronium (0.5-0.6 mg.kg(-1)) and isoflurane. Placement of the MitraClip led to a 60% increase in mean (SD) right ventricular stroke work index (from 512 (321) to 820 (470) mmHg.ml.m(-2), p < 0.0001), while mean (SD) pulmonary vascular resistance index decreased by 24% (522 (330) to 399 (244) dyn.s.cm(-5), p < 0.0001), and mean (SD) pulmonary artery pressure decreased by 10% (30 (8) to 27 (8) mmHg, p < 0.0001). Patients with pulmonary hypertension experienced a similar decrease in mean pulmonary artery pressure compared with those without, and they also had a slight reduction in mean (SD) pulmonary artery occlusion pressure (22 (6) down to 20 (6) mmHg, p = 0.044). We conclude that successful MitraClip treatment for mitral regurgitation acutely improves right ventricular performance by reducing right ventricular afterload, regardless of whether patients have pre-operative pulmonary hypertension.

The MitraClip System: A Systematic Review of Indications, Procedural Requirements, and Guidelines

Transcatheter interventions (TIs) are new treatment options for patients with severe mitral valve regurgitation (MR) who cannot undergo open mitral valve surgery (oMVS). Despite the lack of scientific evidence demonstrating the benefit of these procedures, there has been a steady increase in their use. The aim of this study was to evaluate whether there are any indication criteria, process, and structural requirements, or scientific society and institutional guidelines for the use of the MitraClip System (Abbott Vascular-Structural Heart, Menlo Park, California, United States). A systematic literature search was conducted using the common medical and scientific databases. Of a total of 1,395 publications, 42 publications met the inclusion criteria and were included for the evaluation. Despite a general lack of high-quality evidence and of consensus recommendations from scientific societies or institutions, an assessment of indication criteria and process and structural requirements for the use of the MitraClip System, including noncontrolled studies, was possible. The majority of studies agree that an interdisciplinary heart team including a cardiothoracic surgeon, an interventional cardiologist, and an echocardiographic specialist should actively participate in clinical decision making, and in the procedure itself. Participation in a scientific-based registry is strongly recommended. The MitraClip System is a promising procedure, but evidence-based indication criteria, structural, and process requirements for its use are lacking. Further results from prospective, randomized controlled trials are needed to determine patients, potential adverse events, device durability, and long-term follow-up. MitraClip should be used in only a small number of centers with procedure-specific, high-quality surgical and interventional experience, and training.

Transcatheter valve used in a bailout technique during complicated open mitral valve surgery

Here, we describe the case of a 62-year old woman who required aortic and mitral valve replacement plus coronary artery bypass grafting. Transoesophageal echocardiogram revealed stenosis of the aortic valve (Ao valve area, 0.9 cm(2); PG, 45 mmHg; MG, 25 mmHg) and a diseased calcified mitral valve with stenosis and regurgitation (mitral valve area, 1.1 cm(2); MG, 10 mmHg; RV, 25 ml; ERO, 12 mm(2)). The mitral annulus calcifications were very deep into the left atrium and the left ventricle muscle, around the full annulus circumference. We decided to avoid complete deep mitral annulus decalcification. The left atrium was surgically exposed, and we deployed a 26-mm Edwards SAPIEN XT endovalve through the left atriotomy. To prevent paravalvular leakage, we then used a pericardial patch to close the gap between the endovalve and the calcified mitral annulus. The postoperative echocardiogram showed perfect anchoring of the endovalve in the mitral annulus without any paravalvular leakage.

Panel Backs Approval of Percutaneous Mitral Valve–Repair Device

GAITHERSBURG, MD. – An expert panel narrowly voted in favor of recommending Food and Drug Administration approval of a novel, percutaneously implanted device that repairs the mitral valve, but only for selected patients with significant symptomatic mitral regurgitation but who are poor surgical candidates. Despite an FDA staff conclusion that the device could not be approved, the agency's Circulatory Systems Devices panel voted 5-3 that the benefits of the MitraClip Delivery System in an elderly cohort outweighed the risks for patients at too high a risk for open mitral valve surgery yet still well enough to benefit from correction of mitral regurgitation. The panel was more comfortable with the safety data, unanimously voting that there was “reasonable assurance” that the device was safe for patients who met the criteria in the indication. The panelists generally agreed with the staff conclusions that there were numerous problems with the studies submitted by manufacturer Abbott Vascular – the basis of the FDA's conclusion that the device should not be approved at this time – but they said that they had a sense there were patients who could benefit from treatment. Yea voter Dr. Craig Selzman, who is a cardiothoracic surgeon at the University of Utah, Salt Lake City, stressed that the device should be limited to “truly inoperable patients” and warned about “indication creep,” when a device is rapidly used for treating patients outside the approved indication once it is marketed. He also recommended that the patient be on optimal medical treatment and that an experienced mitral valve surgeon should identify which patients are candidates for treatment. Also voting in favor of approval, Dr. George Vetrovec, professor of medicine and director of the adult cardiac catheterization laboratory at the Medical College of Virginia, Richmond, like several others, cited the improvements in New York Heart Association class in those treated with the device, “which got so much better it couldn't just be happenstance.” Those voting against approval said that a randomized controlled trial was needed before approval. The system includes a delivery catheter and a device that clips together the leaflets of the mitral valve. In its application, Abbott offered data on 351 patients who had functional or degenerative mitral regurgitation, with a mean age of 76 years and a mean ejection fraction of 48%. Implantation was successful in about 95% of patients, and the major effectiveness endpoint, change in left ventricular size after 1 year, significantly improved, with about a 10% reduction in left ventricular volume and dimensions. Other changes included improvements in New York Heart Association class (including a two-class improvement in 36% of patients at 1 year) and significant improvement in a quality-of-life questionnaire. There were also reductions in heart failure hospitalizations in the year after implantation. The patients' mean hospital stay was about 3 days. The primary safety endpoint, 30-day mortality, was 4.8%, which was lower than the mean predicted mortality risk of 18% for this cohort, according to the company. Three of the 17 deaths within the first 30 days were device related. Abbott recently started two studies – one in the United States involving patients with symptomatic functional mitral regurgitation who are not good surgical candidates, the other a postmarketing study in Europe of patients with severe heart failure – and has plans for postmarketing studies in the United States, including 5-year follow-up of the patients in the combined high-risk registry trials, and a national MitraClip patient registry. The device received the equivalent of approval in the European Union in 2008 and is marketed in about 30 countries. The FDA usually follows the recommendations of its advisory panels but is not obligated to do so. All but two panelists were cleared of potential conflicts of interest, and panel chair Dr. Jeffrey Borer, professor of medicine at the State University of New York, Downstate Medical Center in Brooklyn, and Dr. Vetrovec received waivers to participate.

Minimally Invasive versus Open Mitral Valve Surgery a Consensus Statement of the International Society of Minimally Invasive Coronary Surgery (ISMICS) 2010

: The purpose of this consensus conference was to deliberate the evidence regarding whether minimally invasive mitral valve surgery via thoracotomy improves clinical and resource outcomes compared with conventional open mitral valve surgery via median sternotomy in adults who require surgical intervention for mitral valve disease. : Before the consensus conference, the consensus panel reviewed the best available evidence up to March 2010, whereby systematic reviews, randomized trials, and nonrandomized trials were considered in descending order of validity and importance. The accompanying meta-analysis article in this issue of the Journal provides the systematic review of the evidence. Based on this systematic review, evidence-based statements were created for prespecified clinical questions, and consensus processes were used to derive recommendations. The American Heart Association/American College of Cardiology system was used to label the level of evidence and class of each recommendation. : Considering the underlying level of evidence, and notwithstanding the limitations of the evidence base (retrospective studies with important differences in baseline patient characteristics, which may produce bias in results of the evidence syntheses), the consensus panel provided the following evidence-based statements and overall recommendation:In patients with mitral valve disease, minimally invasive surgery may be an alternative to conventional mitral valve surgery (Class IIb), given that there was comparable short-term and long-term mortality (level B), comparable in-hospital morbidity (renal, pulmonary, cardiac complications, pain perception, and readmissions) (level B), reduced sternal complications, transfusions, postoperative atrial fibrillation, duration of ventilation, and intensive care unit and hospital length of stay (level B). However, this should be considered against the increased risk of stroke (2.1% vs 1.2%) (level B), aortic dissection (0.2% vs 0%) (level B), phrenic nerve palsy (3% vs 0%) (level B), groin infections/complications (2% vs 0%) (level B), and, prolonged cross-clamp time, cardiopulmonary bypass time, and procedure time (level B). The available evidence consists almost entirely of observational studies and must not be considered definitive until future adequately controlled randomized trials further address the risk of stroke, aortic complications, phrenic nerve complications, pain, long-term survival, need for reintervention, quality of life, and cost-effectiveness.

Minimally Invasive versus Open Mitral Valve Surgery a Consensus Statement of the International Society of Minimally Invasive Coronary Surgery (ISMICS) 2010

Minimally Invasive versus Open Mitral Valve Surgery a Consensus Statement of the International Society of Minimally Invasive Coronary Surgery (ISMICS) 2010

Minimally Invasive versus Conventional Open Mitral Valve Surgery a Meta-Analysis and Systematic Review

Minimally Invasive versus Conventional Open Mitral Valve Surgery a Meta-Analysis and Systematic Review