Clinical experience with the second-generation 3f Enable sutureless aortic valve prosthesis.

OBJECTIVE: The 3f Enable aortic bioprosthesis (ATS Medical, Inc, Minneapolis, Minn) represents a new generation of equine pericardial self-expanding valve designed for sutureless implantation. This study evaluated technical aspects of implantation and safety and effectiveness of the valve in the short term. METHODS: In an outcome analysis of a consecutive series of 28 patients who underwent aortic valve replacement for aortic stenosis with the 3f Enable during an 18-month period, mean age was 75.7 +/- 6.6 years, 18 patients were female (64.2%), and mean EuroSCORE was 7.1% +/- 1.7%. RESULTS: Most implanted valves were 23 mm in diameter (19-27 mm). Mean aortic crossclamp time was 39 +/- 15 minutes (29-103 minutes), mean cardiopulmonary bypass time was 58 +/- 20 minutes (41-127 minutes), mean hospital stay was 11 days (7-22 days), and 30-day mortality was 3.5%. Mean and peak intraoperative transvalvular pressure gradients were 6.1 +/- 2.6 and 18 +/- 5 mm Hg, respectively. Trivial and mild paravalvular leaks were observed in 1 patient each. One patient underwent reoperative aortic valve replacement 4 months after initial surgery for severe valve-unrelated paravalvular leakage. Five patients (18.5%) required permanent pacemakers. No patients were unavailable for follow-up. One-year survival was 86.2%. CONCLUSIONS: The 3-f Enable aortic bioprosthesis can be implanted safely with favorable early hemodynamics. The self-expanding stent allows sutureless implantation with a large valve area. The procedure was fast, although not as fast as expected. This experience has led to continued design and procedural enhancements to facilitate and accelerate future implantation.

Transapical implantation of a novel self-expanding sutureless aortic valve prosthesis.

BACKGROUND AND AIM OF THE STUDY: To date, transapical aortic valve implantation has required a balloon-expandable stented valve prosthesis. More recently, a novel self-expanding sutureless stented bovine pericardial prosthesis has been developed which allows rapid aortic valve replacement via an open transaortic approach in humans. The aim of this animal study was to develop a reliable protocol to facilitate the transapical implantation of this self-expanding valve in a porcine model. METHODS: Off-pump transapical aortic valve implantation was performed through a left mini-thoracotomy using a bovine pericardial valve mounted on a self-expandable nitinol stent of size 21 mm and 23 mm in 11 pigs (average weight 60 kg). The crimped valve was introduced through the left ventricular apex using a flexible and steerable delivery sheath, using a three-step technique. Biplane fluoroscopy and transesophageal echocardiography were simultaneously used for guidance. Successful adjustment of alignment along three axes prior to deployment of the valve was accomplished in each animal. Deployments were performed during a period of rapid pacing. RESULTS: All valves were successfully deployed and functioned normally following transapical removal of the delivery system. Paravalvular leak was documented in one case (9.1%) due to prosthetic misalignment. There was no evidence of valve migration. Correct anatomic seating was confirmed during post-procedure necropsy. CONCLUSION: Successful transapical implantation of a novel self-expandable bovine pericardial valve was accomplished in 11 animals, without cardiopulmonary bypass. A flexible, steerable delivery system with a three-step release mechanism allowed precise positioning of the valve with a low rate of paravalvular leakage, and excellent device stability.

Addition of dextran sulfate to blood cardioplegia attenuates reperfusion injury in a porcine model of cardiopulmonary bypass.

OBJECTIVE: Contact of blood with artificial surfaces and air as well as ischemia/reperfusion injury to the heart and lungs mediate systemic and local inflammation during cardiopulmonary bypass (CPB). Activation of complement and coagulation cascades leads to and accompanies endothelial cell damage. Therefore, endothelial-targeted cytoprotection with the complement inhibitor and endothelial protectant dextran sulfate (DXS, MW 5000) may attenuate CBP-associated myocardial and pulmonary injury. METHODS: Eighteen pigs (DXS, n=10; phosphate buffered saline [PBS], n=8) underwent standard cardiopulmonary bypass. After aortic cross-clamping, cardiac arrest was initiated with modified Buckberg blood cardioplegia (BCP), repeated after 30 and 60 min with BCP containing either DXS (300 mg/10 ml, equivalent to 5mg/kg) or 10 ml of PBS. Following 30 min reperfusion, pigs were weaned from CPB. During 2h of observation, cardiac function was monitored by echocardiography and invasive pressure measurements. Inflammatory and coagulation markers were assessed regularly. Animals were then sacrificed and heart and lungs analyzed. RESULTS: DXS significantly reduced CK-MB levels (43.4+/-14.8 ng/ml PBS, 35.9+/-11.1 ng/ml DXS, p=0.042) and significantly diminished cytokine release: TNFalpha (1507.6+/-269.2 pg/ml PBS, 222.1+/-125.6 pg/ml DXS, p=0.0071), IL1beta (1081.8+/-203.0 pg/ml PBS, 110.7+/-79.4 pg/ml DXS, p=0.0071), IL-6 (173.0+/-91.5 pg/ml PBS, 40.8+/-19.4 pg/ml DXS, p=0.002) and IL-8 (304.6+/-81.3 pg/ml PBS, 25.4+/-14.2 pg/ml DXS, p=0.0071). Tissue endothelin-1 levels were significantly reduced (6.29+/-1.90 pg/100mg PBS, 3.55+/-1.15 pg/100mg DXS p=0.030) as well as thrombin-anti-thrombin formation (20.7+/-1.0 microg/ml PBS, 12.8+/-4.1 microg/ml DXS, p=0.043). Also DXS reduced cardiac and pulmonary complement deposition, neutrophil infiltration, hemorrhage and pulmonary edema (measured as lung water content, 81+/-3% vs 78+/-3%, p=0.047), indicative of attenuated myocardial and pulmonary CPB-injury. Diastolic left ventricular function (measured as dp/dt(min)), pulmonary artery pressure (21+/-3 mmHg PBS, 19+/-3 mmHg DXS, p=0.002) and right ventricular pressure (21+/-1 mmHg PBS, 19+/-3 mmHg DXS p=0.021) were significantly improved with the use of DXS. CONCLUSIONS: Addition of DXS to the BCP solution ameliorates post-CPB injury and to a certain extent improves cardiopulmonary function. Endothelial protection in addition to myocyte protection may improve post-CPB outcome and recovery.

Experimental stenting of the posterior mitral leaflet to correct prolapse in mitral valve insufficiency.

OBJECTIVE: This study investigated the use of a new concept of mitral valve reconstruction using a novel device to stent the posterior mitral leaflet in combination with semicircular annuloplasty. Modern mitral valve repair is an accepted modality and a routine procedure for treatment of degenerative mitral valve insufficiency. One of the most common mechanisms of mitral valve insufficiency is leaflet prolapse. In the majority of cases the posterior leaflet is dysfunctional and therapeutic reconstruction of the PII flail leaflet segment involves quadrangular resection which is usually combined to mitral annulo-plasty with a ring. A new time-saving concept of mitral valve reconstruction by stenting the posterior mitral leaflet in combination with semicircular annuloplasty is presented. METHODS: The new mitral valve reconstruction device (Shelhigh MitroFast, Shelhigh, Inc., Union, NJ, USA) was implanted in four adult sheep. It is constructed as an annuloplasty ring in combination with a posterior leaflet stent. The device has the shape of a closed posterior leaflet and forms a "buttress" against which the anterior leaflet can coapt. RESULTS: Every implantation of a MitroFast device could be performed in less than 30 minutes. After implantation of the device, all animals could be successfully weaned from CPB. Invasively measured left atrial pressure was below 12 mm Hg in all animals. After chest closure, transoesophageal echocardiography revealed a competent mitral valve in all animals, without any inflow restriction in three animals, and suspected mild stenosis in one animal. CONCLUSIONS: In this experimental model, implantation of the newly designed annuloplasty ring with stenting the posterior mitral leaflet avoids extensive and time-consuming reconstructive surgery on a flail posterior leaflet. Implantation of the device resulted in favorable short-term hemodynamic effects. Implantation technique of the device is simple, the potential for minimal invasive implantation of a conceptual similar device will be further investigated.

Elimination of proinflammatory cytokines in pediatric cardiac surgery: analysis of ultrafiltration method and filter type.

OBJECTIVE: This study was undertaken to assess whether different filter types or ultrafiltration methods influence inflammatory markers in pediatric cardiac surgery. METHODS: Forty-one children younger than 5 years were prospectively randomized to groups A (polyamid filter with conventional ultrafiltration), B (polyamid filter with modified ultrafiltration), C (polysulfon filter with conventional ultrafiltration), and D (polysulfon filter with modified ultrafiltration). Interleukin 6, interleukin 10, tumor necrosis factor, terminal complement complex, and lactoferrin were measured before the operation (T0), before rewarming (T1), after ultrafiltration (T2), at 6 (T3) and 18 hours (T4) after the operation, and in the ultrafiltrate. RESULTS: All markers changed with both ultrafiltration methods, both filter types, and in all groups (except tumor necrosis factor) along the T0 to T4 observation time (P <.0001). Their patterns of changes were different for terminal complement complex, with less decrease after use of the polysulfon filter (P <.05), and among groups A through D for interleukin 6 (P =.01), with more decrease in group C than group A (P <.02). Interleukin 10 decreased with the polyamid filter (P <.001) but not with the polysulfon filter. In the ultrafiltrate, tumor necrosis factor was higher with the polysulfon filter than the polyamid filter (6.8 +/- 5 pg/mL vs 4.0 +/- 3.7 pg/mL, P <.05). The ultrafiltrate/plasma ratio of interleukin 6 was higher with conventional ultrafiltration than modified ultrafiltration (0.018 +/- 0.017 vs 0.004 +/- 0.007, P <.005). CONCLUSIONS: The polysulfon filter showed a filtration profile for inflammatory mediators superior to that of the polyamid filter for interleukin 6, tumor necrosis factor, and interleukin 10. Interleukin 6 was most efficiently removed by conventional ultrafiltration with a polysulfon filter, and tumor necrosis factor was best removed by modified ultrafiltration with a polysulfon filter, whereas other inflammatory mediators were not influenced by filter type or ultrafiltration method. Therefore combined conventional and modified ultrafiltration with a polysulfon filter may currently be the most effective strategy for removing inflammatory mediators in pediatric heart surgery.