Off-pump transapical mitral valve-in-ring implantation (original) (raw)
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Double-crowned valved stents for off-pump mitral valve replacement☆
European Journal of Cardio-Thoracic Surgery, 2005
Objective: An animal model has been designed to assess the feasibility of off-pump mitral valve replacement using valved stents. Methods: Glutaraldehyde-preserved homograft was sutured inside a prosthetic tube (Dacron). Then, two self-expandable nitinol Z-stents were sutured on the external surface of the prosthesis in such a way to create two self-expanding crowns for fixation. In adult pigs and under general anesthesia, the left atrium was exposed through a left thoracotomy and atrio-ventricular roadmapping was performed with intravascular ultrasound (IVUS) and fluoroscopy. The double-crowned valved stents were loaded into a delivery sheath. The sheath was then introduced into the left atrium and the valved stents was deployed in mitral position in such a way that the part in between the two stents was at the level of the mitral annulus. Intracardiac Unltrasound (ICUS) was used to assess the valve function. Hemodynamic parameters were gathered as well. Animal survived for no more than 3 h after the valve deployment and gross anatomy examination of the left heart was carried out. Results: The mean height of the valved stents was 29.4G0.2 mm, with an internal diameter of 20.4G1.0 mm, and an external diameter of 25.5G0.8 mm. The procedure was successfully carried out in eight animals. In vivo evaluation showed a native mitral annulus diameter of 24.9G0.6 mm, and a mean mitral valve area of 421.4G17.5 mm 2 . ICUS showed a mild mitral regurgitation in three out of eight animals. Mean pressure gradient across the valved stents was 2.6G3.1 mmHg. Mean pressure gradient across the left ventricular outflow tract (LVOT) was 6.6G5.2 mmHg. The mean survival time was 97.5G56.3 min (survival time range was 40-180 min). One animal died due to the occlusion of the LVOT because of valved stents displacement. Postmortem evaluation confirmed correct positioning of the valved stent in the mitral position in seven out of eight animals. No atrial or ventricular lesions due to the valved stents were found. Conclusions: Off-pump implantation of a self-expandable valved stent in the mitral position is technically feasible. Further studies will assess if this procedure is also feasible in humans.
Double-crowned valved stents for off-pump mitral valve replacement. Commentary and Discussion
European Journal of Cardio Thoracic Surgery, 2005
Objective: An animal model has been designed to assess the feasibility of off-pump mitral valve replacement using valved stents. Methods: Glutaraldehyde-preserved homograft was sutured inside a prosthetic tube (Dacron). Then, two self-expandable nitinol Z-stents were sutured on the external surface of the prosthesis in such a way to create two self-expanding crowns for fixation. In adult pigs and under general anesthesia, the left atrium was exposed through a left thoracotomy and atrio-ventricular roadmapping was performed with intravascular ultrasound (IVUS) and fluoroscopy. The double-crowned valved stents were loaded into a delivery sheath. The sheath was then introduced into the left atrium and the valved stents was deployed in mitral position in such a way that the part in between the two stents was at the level of the mitral annulus. Intracardiac Unltrasound (ICUS) was used to assess the valve function. Hemodynamic parameters were gathered as well. Animal survived for no more than 3 h after the valve deployment and gross anatomy examination of the left heart was carried out. Results: The mean height of the valved stents was 29.4G0.2 mm, with an internal diameter of 20.4G1.0 mm, and an external diameter of 25.5G0.8 mm. The procedure was successfully carried out in eight animals. In vivo evaluation showed a native mitral annulus diameter of 24.9G0.6 mm, and a mean mitral valve area of 421.4G17.5 mm 2 . ICUS showed a mild mitral regurgitation in three out of eight animals. Mean pressure gradient across the valved stents was 2.6G3.1 mmHg. Mean pressure gradient across the left ventricular outflow tract (LVOT) was 6.6G5.2 mmHg. The mean survival time was 97.5G56.3 min (survival time range was 40-180 min). One animal died due to the occlusion of the LVOT because of valved stents displacement. Postmortem evaluation confirmed correct positioning of the valved stent in the mitral position in seven out of eight animals. No atrial or ventricular lesions due to the valved stents were found. Conclusions: Off-pump implantation of a self-expandable valved stent in the mitral position is technically feasible. Further studies will assess if this procedure is also feasible in humans.
Mitral valved stent implantation
European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2010
To date, transfemoral and trans-apical valved stent implantation techniques are limited to the replacement of pulmonary and aortic valves in a strictly selected group of patients. The current study was designed to assess the short-term follow-up using a mitral valved stent in off-pump technique. A self-expanding, repositionable mitral valved stent was created for trans-apical implantation. Five pigs underwent successful trans-catheter implantation. Data were gathered to assess the animals' haemodynamical stability after stent implantation (n=5), 6h (n=5) and 1 week (n=4). The valved stent function was assessed by trans-oesophageal echocardiography and ventriculogram. Cardiac computed tomography (CT) was used to evaluate positioning of the new implant. Precise valved stent deployment and accurate subsequent adjustment of its intra-annular position allowed for reduction of paravalvular leakage in all animals. The deployment time ranged from 122 to 271 s and blood loss from 65 to 2...
Off-pump transapical mitral valve replacement☆
European Journal of Cardio-Thoracic Surgery, 2009
Objective: Percutaneous valve replacement was recently introduced, and reports of early clinical experience have already been published. To date, this technique is limited to the replacement of pulmonary and aortic valves in a strictly selected group of patients. The aim of this study was to analyse a self-expanding valved stent for minimally invasive replacement of the mitral valve in animals. Methods: A newly designed nitinol stent was specially designed for this experimental acute study. It comprised of a left ventricular tubular stent with star shaped left atrial anchoring springs and carried a trileaflet bovine pericardial valve. A polytetrafluoroethylene membrane was sutured to envelop the atrial springs and the outside of the ventricular stent. The ventricular anchoring system was the same as in our previously reported results with a similar mitral valved stent. Seven pigs underwent minimally invasive off-pump mitral valved stent implantation. This was performed through a lower ministernotomy and a standard transapical approach under transoesophageal echocardiographic (TEE) guidance was used. Results: The valved stent is fully retrievable and precise deployment and accurate adjustment of its intra-annular position is achievable to eliminate paravalvular leakage. The deployment time ranged from 127 to 255 s and the blood loss from 70 to 220 cc. One animal died of intractable ventricular fibrillation. Mitral regurgitation in all surviving animals was minimal (trace in 5/6 and mild in 1/6 during echo examination; on the contrast ventriculogram no mitral insufficiency was observed except in one documented as mild paravalvular regurgitation). These animals remained haemodynamically stable (6/ 6) and without TEE or ventriculographic changes for 1 h. Conclusion: Implantation of a tricuspid bovine pericardial valved stent in the mitral position is feasible in pigs through a transcatheter approach. This was possible through a smaller delivery system than previously reported. Additional studies are required to demonstrate long-term feasibility, durability, and heart function. #
Off-pump transapical mitral valve replacement. Discussion
European Journal of Cardio Thoracic Surgery, 2009
Objective: Percutaneous valve replacement was recently introduced, and reports of early clinical experience have already been published. To date, this technique is limited to the replacement of pulmonary and aortic valves in a strictly selected group of patients. The aim of this study was to analyse a self-expanding valved stent for minimally invasive replacement of the mitral valve in animals. Methods: A newly designed nitinol stent was specially designed for this experimental acute study. It comprised of a left ventricular tubular stent with star shaped left atrial anchoring springs and carried a trileaflet bovine pericardial valve. A polytetrafluoroethylene membrane was sutured to envelop the atrial springs and the outside of the ventricular stent. The ventricular anchoring system was the same as in our previously reported results with a similar mitral valved stent. Seven pigs underwent minimally invasive off-pump mitral valved stent implantation. This was performed through a lower ministernotomy and a standard transapical approach under transoesophageal echocardiographic (TEE) guidance was used. Results: The valved stent is fully retrievable and precise deployment and accurate adjustment of its intra-annular position is achievable to eliminate paravalvular leakage. The deployment time ranged from 127 to 255 s and the blood loss from 70 to 220 cc. One animal died of intractable ventricular fibrillation. Mitral regurgitation in all surviving animals was minimal (trace in 5/6 and mild in 1/6 during echo examination; on the contrast ventriculogram no mitral insufficiency was observed except in one documented as mild paravalvular regurgitation). These animals remained haemodynamically stable (6/ 6) and without TEE or ventriculographic changes for 1 h. Conclusion: Implantation of a tricuspid bovine pericardial valved stent in the mitral position is feasible in pigs through a transcatheter approach. This was possible through a smaller delivery system than previously reported. Additional studies are required to demonstrate long-term feasibility, durability, and heart function. #
Transapical Mitral Valved Stent Implantation
The Annals of Thoracic Surgery, 2008
Background. Transcatheter aortic and pulmonary valve replacement is currently being tested in human trials. Efforts to create a valved stent to replace the atrioventricular valves have shown limited success. This is due to their their complex anatomy and function.
The Journal of Thoracic and Cardiovascular Surgery, 2014
Objective: Transcatheter heart valve (THV) procedures are constantly evolving. We report our experience with valve-in-valve, valve-in-ring, and direct-view valve-in-native-ring implantation in the mitral position. Methods: Fourteen patients undergoing THV implantation in the mitral position were included. Clinical and postoperative data, including echocardiography and further follow-up, were analyzed. Results: Ten valve-in-valve and 2 valve-in-ring procedures were successfully performed using the transapical access route. For the third valve-in-ring procedure we used an antegrade left-atrial access via right anterolateral minithoracotomy. In 1 patient surgical mitral valve replacement was planned. Intraoperatively, the annulus appeared severely calcified and regular implantation of a bioprosthesis was not possible. As a last resort, a 29-mm Sapien XT valve (Edwards Lifesciences Inc, Irvine, Calif) was implanted under direct view. The initial result was satisfactory, but on the first postoperative day relevant paravalvular regurgitation occurred. Subsequently, the valve was fixed to an atrial cuff by 1 running suture. In this series 27-, 29-, and 31-mm bioprostheses and 28-and 30-mm annuloplasty rings were treated with 26-or 29-mm Sapien XT valves. Postoperative echocardiography on day 10 and after 6 weeks revealed good prosthesis function in all cases. In 2 valve-in-valve patients who solely received anticoagulation therapy with acetylsalicylic acid, signs of beginning valve thrombosis occurred after 8 weeks and 3 months, respectively. During further course, valve function was normalized using warfarin therapy. Conclusions: Our results demonstrate feasibility of valve-in-valve and valve-in-ring THV procedures in the mitral position. Permanent anticoagulation therapy with warfarin seems to be necessary to prevent valve dysfunction. THV implantation in a calcified native mitral ring for bailout seems not to be reproducible and thus cannot be recommended.
European Journal of Cardio-Thoracic Surgery, 2009
Objective: Based upon recent developments in transcatheter technology, this study was designed to evaluate the feasibility and haemodynamic performance of transcatheter valve-in-a-ring (VinR) implantation for potentially failed mitral repair using a minimally invasive, transatrial, off-pump approach. Methods: Adult sheep (54.3 AE 3.0 kg) underwent mitral valve repair with a 26 mm complete annuloplasty ring (Physio TM) using standard conventional techniques. To simulate the redo operation, a transcatheter 23 mm pericardial prosthesis (Edwards Sapien TM) mounted on a balloon-inflatable steel stent was deployed within the annuloplasty ring. VinR implantation was performed off-pump under rapid pacing in four and on-pump in three animals using an antegrade transatrial approach under fluoroscopic guidance. Results: Transcatheter VinR implantation was successful in all seven sheep. Mean transvalvular gradient was 4.9 AE 0.3 mmHg. VinR function was excellent with no leak in one, good with mild leak in five (trans-stent: four, paravalvular: one) and sufficient with moderate central leak in one animal, respectively. Valve deployment required 10.0 AE 0.7 min and all transcatheter prostheses were confirmed in good position on postmortem analysis, without any signs of valve dislocation or embolisation. In an in-vitro model, the minimum force required to dislodge the valve was 32.9 AE 5.2 N, which was well above the normal estimated forces generated by the left ventricle. One animal was kept alive to assess mid-term outcome and is still well 12 months after the VinR implantation. Conclusions: Transatrial, transcatheter mitral VinR implantation is feasible using a minimally invasive off-pump approach. VinR implantation is a promising concept for re-operative surgery for selected patients after failed mitral valve repair.