Direct access transcatheter mitral annuloplasty with a sutureless and adjustable device: preclinical experience†

OBJECTIVES The aim of the study was to evaluate the technical feasibility and performance of a transcatheter mitral annuloplasty system. METHODS Adult swines (n=15) underwent left thoracotomy through the 4th-5th intercostal space. A transcatheter device (CardioBand, Valtech-Cardio Ltd) was introduced through an 18F sheath through the left atrium and attached to the annulus between the posterior and anterior commissures using echocardiographic and fluoroscopic guidance, on the beating heart. The sutureless device was implanted using a steerable delivery system to deploy sequential fixation elements. Following implantation, the device length was adjusted on the beating heart to reduce the intercommissural and septolateral dimension, under echocardiographic guidance. Finally, the flexible adjustment tool was withdrawn from the working sheath and the atrial purse-string closed. All but five animals were sacrificed acutely by intent, while the others were sacrificed at 90 days. RESULTS All animals survived the acute implant. One animal died at the third post-operative day due to bleeding. The annuloplasty system was successfully implanted in all animals. A mean of 12±3 fixation elements were deployed. The band length was reduced up to 20% after implantation in each animal. At necropsy, the location of the implant was within a few millimetres of the annulus (3.5±4mm). In three animals, fixation elements were implanted inadvertently in the leaflets, but no coronary lesions were observed. All animals survived the acute implant. One animal died on the third post-operative day due to bleeding. In the four long-term survivors, the implanted annuloplasty device showed satisfactory healing and no ring dehiscence. CONCLUSIONS Transcatheter minimally invasive, beating-heart implantation of an adjustable annuloplasty band is feasible in the animal model. This approach may be an alternative to open surgical procedures in high-risk patient

Live broadcasting in cardiac surgery does not increase the operative risk

Objective: Live broadcasting of cardiac surgical procedures has an educational intention. There is an ongoing debate whether live surgery increases risk. Aim of this study was to evaluate the outcomes of patients who underwent a cardiac surgical procedure during live broadcasting. Methods: A total of 250 cardiac operations were performed during 32 live broadcastings at four different clinical sites between 1999 and 2009. Data on patient characteristics, intra-operative procedures and patient short- and long-term outcome were collected and analyzed. All participating centers complied with the rules for the conduct of live surgery developed by the European Association of Cardiovascular and Thoracic Surgery (EACTS) Techno College Committee. Results: Primary educational focus was the mitral valve in 126 cases, aortic valve including transcatheter valve implantations in 34, coronary artery bypass grafting (CABG) in 29, congenital in 26, aortic (ascending, arch, and descending) in 15, atrial fibrillation in 13, and heart failure in seven. Mean EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 8.7±11.5 (range: 0.8-72). Thirty-day mortality was 1.2% (3/250): reasons for death were multi-organ failure in two and respiratory failure in one patient, respectively. Stroke rate was 2.4% (6/250). Five patients (2%) required cardiac re-operations within 30 days. The rate of mitral valve repair was 96% (121) and compares favourably with repair rates presented in national registries. Mean follow-up of all patients was 3.7±2.8 years with an estimated survival of 92% (95% confidence interval (CI): 87-95%) at 5 years. Conclusions: Based on this large experience there is no evidence for an excess perioperative risk for patients operated under the conditions of live broadcastin

Beating-heart implantation of adjustable length mitral valve chordae: acute and chronic experience in an animal model

Objective: This study aimed to determine the acute and chronic performance of a new system designed to conduct beating-heart implantation and off-pump adjustment of neochordal length. Methods: In 14 adult sheep (group A) selected to undergo beating-heart cardiopulmonary bypass, the left atrium was opened through a left thoracotomy. Two or more primary chordae in the A2 region were severed to produce a model of a flail leaflet. A chordal adjustment mechanism (V-Chordal, Valtech Cardio Ltd., Or-Yehuda, Israel) was affixed to the head of the papillary muscle. The system includes two adjustable neochordae. The distal end of the neochordae was sutured to the flail segment without estimating the appropriate length. The neochordal length was adjusted off-pump under real-time echo-guidance. The adjustment tool was removed and the atriotomy was closed with a purse-string suture. Control animals (group B, n=4) were implanted with the conventional neochordae. Animals in both groups were sacrificed 3 months after the procedure. Results: In both groups, prior to repair, mitral regurgitation (MR) was severe in all animals. In group A, following adjustment of neochordae, MR was absent in all animals, with the exception of two animals that had residual 2+ MR irresponsive to neochordae adjustments. In group B, MR was 2+ in two of the four animals following repair. At 3 months, mitral competence was stable in all animals. At necropsy, normal healing of the papillary head and leaflet was observed in both the groups. Conclusions: The V-Chordal system simplifies the process of neochordal implantation and precise off-pump adjustment of the neochordal length to correct MR occurring due to a flail leaflet. This technology may improve the technical feasibility for adoption of chordal repair during open or minimally invasive surgical procedure

Improving mitral valve coaptation with adjustable rings: outcomes from a European multicentre feasibility study with a new-generation adjustable annuloplasty ring system†

OBJECTIVES To evaluate the performance and safety of an adjustable semi-rigid annuloplasty ring for mitral regurgitation (MR) in a multicentre study. METHODS Between March 2010 and December 2011, 30 subjects underwent mitral valve (MV) repair using the Cardinal adjustable annuloplasty ring. This device is a semi-rigid ring allowing postimplantation size adjustment, under beating-heart conditions, to optimize leaflet coaptation under echocardiographic guidance. Coaptation length was determined before and after adjustment by transoesophageal echocardiography. RESULTS The study enrolled 21 (70%) male and 9 (30%) female subjects with a mean age of 64 years. The approach was conventional midline sternotomy or mini-invasive right thoracotomy. Leaflet resection was done in 17 subjects, and chordal repair was used in 13. Concomitant procedures included coronary artery bypass grafting in 2 (7%) subjects, atrial ablation in 4 (13%) and tricuspid repair in 4 (13%). There was 1 (3%) early death unrelated to the study device. Intraoperative ring adjustment was performed in 24 of the 30 subjects. Residual MR was detected prior to adjustment in 6 subjects (4 mild and 2 moderate MR). Following adjustment, 5 subjects had no MR and 1 had trace MR. After adjustment, mean coaptation length improved from 7 ± 3 to 10 ± 3 mm (P < 0.0001). All patients who completed 1-year follow-up had less-than-mild MR, with the exception of 1 patient with ring dehiscence (and resultant 2+ MR) and 1 functional MR patient who developed recurrent 2+ MR due to persistent leaflet tethering. CONCLUSIONS MV repair with the Cardinal adjustable annuloplasty ring is a reliable technique that enables the adjustment of the ring diameter on a beating heart under echocardiographic control. Such technology allows the optimization of leaflet coaptation, providing minimal residual MR and durable repai

Comparison of outcomes of minimally invasive mitral valve surgery for posterior, anterior and bileaflet prolapse §

Abstract Objective: We sought to compare the outcomes of minimally invasive mitral valve (MV) surgery for anterior (anterior mitral leaflet, AML), posterior (posterior mitral leaflet, PML) or bileaflet (BL) MV prolapse. Methods: Between August 1999 and December 2007, 1230 patients who presented with isolated AML (n = 156, 12.7%), isolated PML (n = 672, 54.6%) or BL (n = 402, 32.7%) MV prolapse underwent minimally invasive MV surgery. The preoperative mitral regurgitation (MR) grade was 3.3 AE 0.8, left ventricular ejection fraction (LVEF) was 62 AE 12% and mean age was 58.9 AE 13.0 years; 836 patients (68.0%) were male. Mean follow-up time was 2.7 AE 2.1 years, and the follow-up was 100% complete. Results: Overall, the MV repair rate was 94.0% (1156 patients). Seventy-four patients (6.0%) received MV replacement. MV repair for PML prolapse was accomplished in 651 patients (96.9%), for AML in 142 patients (91%) and for BL in 363 patients (90.3%). Repair techniques consisted predominantly of leaflet resection and/or implantation of neochordae, combined with ring annuloplasty. Concomitant procedures were tricuspid valve surgery (n = 56), atrial fibrillation ablation (n = 286) and closure of an atrial septal defect or patent foramen ovale (PFO) (n = 89). The overall duration of cardiopulmonary bypass was 127 AE 40 min and aortic cross-clamp time was 78 AE 33 min. The mean postoperative hospital stay was 11.6 AE 9.7 days for the overall group. Early echocardiographic follow-up revealed excellent valve function in the vast majority of patients, regardless of the repair technique, with a mean MR grade of 0.3 AE 0.5. For the overall group, 5-year survival rate was 87.3% (95% CI: 83.9-90.1) and 5-year freedom from cardiac reoperation rate was 95.6% (95% CI: 94.1-96.7). The log-rank test revealed no significant difference between the three groups regarding long-term survival or freedom from reoperation. Conclusions: Minimally invasive MV repair can be achieved with excellent results. Long-term outcomes and reoperation rates for AML prolapse are not significantly different from PML or BL prolapse.

Real-time three-dimensional echocardiographic assessment of mitral valve: Is it really superior to 2D transesophageal echocardiography?

Aim of our study was to investigate the feasibility of use and possible additional value of real-time 3D transesophageal echocardiography (RT-3D-TEE) compared to conventional 2D-TEE in patients undergoing elective mitral valve repair. After ethical committee approval, patients were included in this prospective study. After induction of anesthesia, a comprehensive 2D-TEE examination was performed, followed with RT-3D-TEE. The intraoperative surgical finding was used as the gold standard for segmental analysis. Only such segments which were surgically corrected either by resection or insertion of artificial chords were judged pathologic. A total of 50 patients were included in this study; usable data were available from 42 of these patients . Based on the Carpentier classification, the pathology found was type I in 2 (5&#x0025;) patients, type II in 39 (93&#x0025;) patients and type IIIb in 1 (2&#x0025;) patient. We found that 3D imaging of complex mitral disease involving multiple segments, when compared to 2D-TEE did not show any statistically significant difference.RT-3D-TEE did not show any major advantage when compared to conventional 2D-TEE for assessing mitral valve pathology, although further study in a larger population is required to establish the validity of this study