Domenico Mazzitelli1, Theodor Fischlein2, J Scott Rankin3, Yeong-Hoon Choi4, Christof Stamm5, Steffen Pfeiffer2, Jan Pirk6, Christian Detter7, Johannes Kroll8, Friedhelm Beyersdorf8, Charles D Griffin9, Malakh Shrestha10, Christian Nöbauer1, Philip S Crooke11, Christian Schreiber1, Rüdiger Lange1. 1. Department of Cardiovascular Surgery, Deutsches Herzzentrum München, Munich, Germany. 2. Department of Cardiovascular Surgery, Klinikum Nürnberg, Paracelsus Medical University, Nuremberg, Germany. 3. Cardiothoracic Surgery Associates, Nashville, TN, USA jsrankinmd@cs.com. 4. Department of Cardiac and Thoracic Surgery, University of Köln, Cologne, Germany. 5. Department of Cardiac Surgery, Deutsches Herzzentrum Berlin, Berlin, Germany. 6. Department of Cardiac Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic. 7. Department of Cardiovascular Surgery, University Heart Center, Hamburg, Germany. 8. Department of Cardiovascular Surgery, Albert-Ludwigs University, Freiburg, Germany. 9. BioStable Science and Engineering, Inc., Austin, TX, USA. 10. Department of Cardiothoracic Surgery, Hannover Medical School, Hannover, Germany. 11. Department of Mathematics, Vanderbilt University, Nashville, TN, USA.
Abstract
OBJECTIVES: This study assessed the safety and efficacy of an internal geometric annuloplasty ring in a regulatory trial of aortic valve reconstruction (ClinicalTrials.gov Identifier: NCT01400841). METHODS: Sixty-five patients with predominant moderate-to-severe trileaflet aortic insufficiency (AI) underwent aortic valve repair with an average age of 63 ± 13 years (mean ± SD). All had initial implantation of an internal aortic annuloplasty ring to correct annular dilatation and facilitate leaflet reconstruction. Leaflet plication was performed for prolapse in 80% of patients, and more complex leaflet procedures, usually employing autologous pericardium, were required in 22%. Ascending aortic and/or root aneurysms were replaced in 62%. RESULTS: Follow-up was for a maximum of 3 years and a mean of 2 years. No in-hospital operative mortalities, major complications or early or late valve-related events occurred. The annular diameter before repair was 26.5 ± 2.3 mm, and the average ring diameter used was 21.5 ± 1.6 mm. The preoperative AI grade (0-4) was 2.9 ± 0.8 and improved after repair to 0.6 ± 0.7 (P < 0.0001), as did the NYHA class. The mean valve gradient was 8.6 ± 4.3 mmHg, and at 3 years, the Kaplan-Meier survival rate was 95%, with no valve-related mortality. Over the 3 years, aortic valve replacement was required in 7 patients (10.8%) for reasons usually related to surgical technique. Most repair failures occurred early, and results stabilized after 6 months. No structural complications of the rings were observed. CONCLUSIONS: Geometric ring annuloplasty was a safe and effective adjunct to aortic valve repair. Initial correction of annular dilatation seemed to facilitate overall reconstruction. Because most early repair failures were technical, increasing experience with geometric ring annuloplasty for aortic valve reconstruction has the potential to standardize and improve outcomes.
OBJECTIVES: This study assessed the safety and efficacy of an internal geometric annuloplasty ring in a regulatory trial of aortic valve reconstruction (ClinicalTrials.gov Identifier: NCT01400841). METHODS: Sixty-five patients with predominant moderate-to-severe trileaflet aortic insufficiency (AI) underwent aortic valve repair with an average age of 63 ± 13 years (mean ± SD). All had initial implantation of an internal aortic annuloplasty ring to correct annular dilatation and facilitate leaflet reconstruction. Leaflet plication was performed for prolapse in 80% of patients, and more complex leaflet procedures, usually employing autologous pericardium, were required in 22%. Ascending aortic and/or root aneurysms were replaced in 62%. RESULTS: Follow-up was for a maximum of 3 years and a mean of 2 years. No in-hospital operative mortalities, major complications or early or late valve-related events occurred. The annular diameter before repair was 26.5 ± 2.3 mm, and the average ring diameter used was 21.5 ± 1.6 mm. The preoperative AI grade (0-4) was 2.9 ± 0.8 and improved after repair to 0.6 ± 0.7 (P < 0.0001), as did the NYHA class. The mean valve gradient was 8.6 ± 4.3 mmHg, and at 3 years, the Kaplan-Meier survival rate was 95%, with no valve-related mortality. Over the 3 years, aortic valve replacement was required in 7 patients (10.8%) for reasons usually related to surgical technique. Most repair failures occurred early, and results stabilized after 6 months. No structural complications of the rings were observed. CONCLUSIONS: Geometric ring annuloplasty was a safe and effective adjunct to aortic valve repair. Initial correction of annular dilatation seemed to facilitate overall reconstruction. Because most early repair failures were technical, increasing experience with geometric ring annuloplasty for aortic valve reconstruction has the potential to standardize and improve outcomes.
Authors: Oliver K Jawitz; Vignesh Raman; Jatin Anand; Muath Bishawi; Soraya L Voigt; Julie Doberne; Andrew M Vekstein; E Hope Weissler; Joseph W Turek; G Chad Hughes Journal: Eur J Cardiothorac Surg Date: 2020-06-01 Impact factor: 4.191
Authors: Arnar Geirsson; Clarence H Owen; Robert S Binford; Rochus K Voeller; Christopher R Burke; Jeffrey D McNeil; Lawrence M Wei; Vinay Badhwar; J Scott Rankin Journal: JTCVS Tech Date: 2022-03-03
Authors: Jacek H Juściński; Andrzej Koprowski; Magdalena Kołaczkowska; Maciej M Kowalik; Jan A Rogowski; James S Rankin Journal: Kardiochir Torakochirurgia Pol Date: 2018-03-28
Authors: Marc W Gerdisch; T Brett Reece; Dominic Emerson; Richard S Downey; Geoffrey B Blossom; Arun Singhal; Joshua N Baker; Theodor J M Fischlein; Vinay Badhwar Journal: JTCVS Tech Date: 2022-06-09
Authors: Arun K Singhal; Jarrod Bang; Anthony L Panos; Andrew Feider; Satoshi Hanada; J Scott Rankin Journal: J Card Surg Date: 2022-04-26 Impact factor: 1.778