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Objective: Trans-apical beating-heart implantation of neo-chordae is yet an experimental procedure for mitral valve (MV) repair. We aimed to assess the performance of a new device in an acute animal study., Methods: A total of four domestic adolescent pigs were used as an acute model. The MV was assessed on the beating heart through a conventional trans-apical access. The NeoChord DS1000 device was used to implant polytetrafluoroethylene (PTFE) sutures to the MV leaflets. Procedural performance of the device was assessed and completed with surgical workflow analysis., Results: Overall 57 implantations using epicardial echocardiography guidance were performed (mean 14.3 implantations per animal). The MV leaflets were successfully grasped every second attempt (mean 2.3±1.9) with no difference between the anterior and the posterior leaflet. A significant difference between an 'expert' surgeon (n>20 implantations) and beginner surgeon was detected with regard to the duration for successful leaflet grasping (65±73 vs 127±105 s; p=0.02) and the overall duration for implantation (130±86 vs 230±119 s; p=0.002). Gross anatomy did not show major tear of leaflets. There were no device-related technical problems., Conclusion: The NeoChord DS1000 device for trans-apical beating-heart implantation of neo-chordae to the MV valve showed a high procedural success. A significant difference between an expert and beginner surgeon was detected, which emphasizes the importance of training before introduction of this new technique into clinical practice. Surgical workflow analysis proved to be a valuable tool to assess the performance of this new technique.

Background and Aim of the Study: The study aim was to evaluate the mid-term results after implantation of the stented porcine xenograft (Epic valve with Linx anticalcification treatment) in elderly patients., Methods: A total of 1,368 patients undergoing aortic valve replacement (AVR; n = 1,168), mitral valve replacement (MVR; n = 101) or double valve replacement (DVR; n = 105) between November 2001 and November 2006, was evaluated. The indication for Epic implantation was patient age > or = 70 years, with pathology not amenable to valve repair. Outcome was assessed by reviewing a prospectively acquired hospital database, in addition to annual clinical follow up., Results: The mean patient age was 76 +/- 6 years (AVR), 73.7 +/- 6 years (MVR), and 73.1 +/- 7 years (DVR); among these patient subgroups, 50.3%, 65.3% and 57.7%, respectively, were female, and 16.4%, 25.5% and 40.0% presented with endocarditis. The logistic EuroSCORE predicted risk for mortality was 14.1 +/- 14%, 19.3 +/- 18%, and 20.3 +/- 20%, respectively. Additional surgical procedures included mitral valve repair in 103 patients (all AVR), CABG in 587 patients (515 AVR, 29 MVR, 43 DVR), left atrial ablation therapy in 70, 16 and nine patients respectively, and surgery on the thoracic aorta in 54, zero and 12 patients, respectively. The mean aortic cross-clamp time was 72 +/- 28, 84 +/- 44 and 133 +/- 48 min after AVR, MVR and DVR, respectively. Freedom from stroke events after five years was 99.0 +/- 0.3%, 97.3 +/- 1.9% and 100%, respectively; freedom from bleeding events after five years was 99.5 +/- 0.2%, 100% and 99.0 +/- 1.0%, and actuarial freedom from reoperation due to prosthetic valve endocarditis 98.9 +/- 0.7%, 96.7 +/- 1.9% and 92.4 +/- 3.4%. Among these patients groups, early mortality was 8.0 +/- 0.8%, 17.8 +/- 3.8% and 21.9 +/- 4.0%, and five-year survival 77.0 +/- 4.1%, 71.7 +/- 4.5% and 55.5 +/- 6.3%. Perioperative survival in non-endocarditis patients undergoing isolated valve surgery was 95.8 +/- 0.9%, 96.4 +/- 3.5% and 90.0 +/- 6.7% after AVR, MVR or DVR, respectively, while the five-year survival was 90.6 +/- 1.5%, 89.3 +/- 5.8% and 90.0 +/- 6.7%., Conclusion: Clinical outcome at five years after porcine valve replacement using the Epic xenograft was satisfactory in elderly patients. The clinical effectiveness of the Linx anticalcification treatment remains to be proven during longer-term follow up.

Background: The purpose of this study was to analyze the 5- to 8-year clinical results after prospectively randomized stentless versus conventional aortic valve replacement., Methods: Two hundred twenty-three patients received stentless (Freestyle or Toronto, n = 127) or conventional stented (CE porcine, n = 96) xenograft aortic valve replacement between March 1996 and March 1999 using a prospectively randomized protocol and were discharged from the hospital. Patient age at operation was 71.8 +/- 6.7 years stentless and 74.9 +/- 4 years stented (p < 0.05). There were no significant differences regarding preoperative morphologic and hemodynamic variables. Aortic annulus diameter indices were comparable at 13.5 mm stentless and 13.6 mm stented. Follow-up after 6.9 +/- 0.8 years is complete for 95.6% of the patients at a total of 1,533 patient-years. Analysis of variance, unpaired t test, univariate (chi2), and survival analysis (log rank) were performed., Results: Eight-year survival was 78.1% +/- 3.8% stentless versus 66% +/- 4.9% stented (p = 0.04); mean survival was 97 months stentless versus 88 months stented. At most recent follow-up, New York Heart Association functional class was 1.6 +/- 0.6 stentless versus 1.5 +/- 0.7 stented (p = not significant); ejection fraction was 61% +/- 11% versus 61% +/- 8% (p = not significant); transvalvular maximum flow velocity was 23 +/- 9 mm Hg versus 37 +/- 15 mm Hg (p < 0.01). Thrombembolic events occurred in 2 of 7 patients, including 2 of 6 patients suffering major stroke (p = not significant). Most (93%) of the patients were satisfied with the postoperative course, having a significantly improved quality of life., Conclusions: Midterm results after xenograft aortic valve replacement are satisfactory. Overall survival is significantly better after stentless aortic valve replacement in this series. However, there was no cause and effect relationship between lower transvalvular pressure gradient. Fewer thrombembolic events and better survival rates were proven.