Freestyle stentless bioprosthesis for aortic valve therapy: 17-year clinical results

Ennker, J.; Meilwes, Markus; Pons-Kuehnemann, Joern; Niemann, Bernd; Grieshaber, Philippe; Ennker, I. C.; Boening, Andreas

doi:10.1177/0218492316675244

Cited by 10 publications

(10 citation statements)

References 17 publications

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“…30 The rationale of using the stentless biological material in valve replacement surgery are the excellent hemodynamic profile, low risk of thromboembolism, and low risk of prosthetic valve infection due to the absence of artificial material. 31,32 Böning et al furthermore reported that conventional reoperation for stentless porcine xenograft root replacement could be performed with the same intraoperative results, though the 30-day mortality was worse in the xenograft group, explained by a higher amount of concomitant procedures. 33 Carefully considering patient individual CT morphological conditions, especially for nonstented valves, the option to implant transcatheter valves in case of biological valve degeneration as valve in valve procedure is a challenging but upcoming trend for reoperation in the future, especially in the older patient population with high risk of reoperation.…”

Section: Discussionmentioning

confidence: 95%

Outcomes of Patients after Implantation of the Pericardial All-Biological Valve No-React Aortic Conduit (BioIntegral) for Root Replacement in Complex Surgical Procedures

Puehler

Freitag‐Wolf

Friedrich

et al. 2019

Thorac Cardiovasc Surg

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Objective Therapy of complex aortic root pathologies remains a great surgical challenge. Though different graft materials are available to replace the often-destroyed aortic root, long durability and freedom from reoperation of the latter are still under debate. The aim of our study was to investigate patients' postoperative outcome after implantation of the BioIntegral conduit in complex aortic root pathologies. Methods From February 2014 to May 2017, 33 consecutive patients (69.7% male) with a median age of 73 (57.5; 76.2) years underwent aortic root replacement with the BioIntegral conduit at our institution. Severe aortic valve endocarditis (78.8%) was the predominant indication for surgery. In 28 patients (84.9%), implantation was performed as redo or in 87.8% as urgent and emergent surgery. Primary end-point was the 30-day survival time, evaluated by Cox regression analysis. Secondary midterm outcome and graft-related reoperation were analyzed. Results Median follow-up for all patients was 178 (8; 659) days. Median EuroScore II was 19.9% (13.4; 29.9). Freedom from reoperation was 97%. The overall 30-day mortality rate was 33% mainly caused by multiorgan failure in six (18.2%) patients and cardiac failure in five (15.1%) patients. One further death occurred during follow-up at day 156. None was directly conduit-related. Graft reinfection after the 4th surgery with basal abscess formation occurred in only one patient (3%). Early echocardiographic assessment of the valve revealed good functional results. A higher EuroScore II was significantly associated with a poorer 30-day survival time (hazard ratio, 1.039; 95% confidence interval, 1.015–1.063, p = 0.001). Conclusion Aortic root replacement for complex pathologies is associated with substantial 30-day mortality, but survival of patients after discharge from hospital was stable. Early functional status of the BioIntegral valve was good. Though freedom from re-operation was low, long-term outcome and long-term functional status have to be further evaluated.

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Section: Discussionmentioning

confidence: 95%

Outcomes of Patients after Implantation of the Pericardial All-Biological Valve No-React Aortic Conduit (BioIntegral) for Root Replacement in Complex Surgical Procedures

Puehler

Freitag‐Wolf

Friedrich

et al. 2019

Thorac Cardiovasc Surg

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“…In both cohorts, despite different indications for operation, the in-hospital mortality and the survival do not differ signi cantly, also taking into account that concomitant procedures were carried out more often in the non-OA group. As there are 3 patients at risk after 10 years in the non-OA group, we would like to concentrate on the survival at 1 and 5 years which is compareable with current literature including different pathologies and is not showing a signi cant difference between both groups [14,15].…”

Section: Discussionmentioning

confidence: 99%

“…The favorable hemodynamic properties with a low thrombogenicity, acceptable durability and reduced transvalvular gradients demonstrate an advantage of the Freestyle® prosthesis [27]. The degeneration rate in literature reviewing long-term outcomes including a follow-up over more than 10 years shows a rate of 6.2-7.9% and a linearized detoriation rate 0.2% /100 patient years [14,15].…”

Section: Valve Degeneration and Gradientsmentioning

confidence: 99%

Freestyle Aortic Root Prosthesis in Combination with Aortic Replacement and Open Anastomosis: A Retrospective Analysis.

Zientara

Rosselet-Droux

Bruijnen

et al. 2021

Preprint

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Background: The Freestyle® bioprosthesis is used for pathologies of the aortic root. Additional resection of the ascending aorta and the proximal arch in dissections or aneurysms might be indicated. The aim was to assess mid-term outcome regarding prosthetic performance, stroke, reoperations, and survival in various pathologies comparing patients with and without additional procedures on the ascending aorta and proximal arch focusing on the standardized technique of unilateral antegrade cerebral perfusion under moderate hypothermia. Methods: Retrospective data analysis of 278 consecutive patients after Freestyle® root replacement between September 2007 and March 2017. Patients were divided in three categories due to the pathology of the aortic root (re-operation vs endocarditis vs dissection). Two groups based on the aortic anastomosis technique (non-open arch anastomosis (non-OA) versus open arch anastomosis (OA)) were compared (119 OA vs 159 non-OA). Cardiovascular risk, previous cardiac events, intra- and postoperative data were evaluated. Inferential statistics were performed with Mann-Whitney U-test. Nominal and categorical variables were tested with Fisher-Freeman-Halton exact test. Kaplan-Meier estimate was used to assess survival.Results: The follow-up rate was 90% (median follow-up: 39.5 months). There were differences in the indication (endocarditis: OA 5 (4.2%) vs non-OA 36 (24%), p<0.0001; dissection: OA 13 (10.9%) vs non-OA 2 (1.3%); p=0.0007). OA patients had less perioperative stroke (1 (1%) vs 15 (10%), p=0.001) and shorter hospital stay (9 vs 12 days, p=0.0004). There were no differences in the mortality (in-hospital: non-OA 8 (5%) vs OA 8 (7%); p=0.6; death at follow-up: non-OA 15 (11%) vs OA 5 (5%); p=0.1). Overall valve performance showed a well-functioning valve in 97.3% at follow-up.Conclusion: The valve performance showed excellent results regardless of the initial indication. The incidence of stroke was lower in patients receiving an open arch anastomosis using unilateral antegrade cerebral perfusion without elevated mortality or prolonged hospital stay.

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“…After initial excellent results, both the prostheses were withdrawn from the market, mainly due to the premature structural deterioration and the high risk of related reoperation 8,9 . Another stentless porcine aortic root, the Medtronic Freestyle aortic root (Medtronic Inc Minneapolis, MN), manufactured with an original anticalcification treatment, is still widely used for aortic root replacement with excellent long‐term results 10,11 . The Shelhigh bio‐conduit NR‐2000 (Shelhigh Inc, Milburn, NY,) as previously described, was a true, ready to use full‐biological stentless conduit.…”

Section: Discussionmentioning

confidence: 99%

Long‐term follow‐up after Bentall operation using a stentless Shelhigh NR‐2000 bio‐conduit

et al. 2020

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Background: To analyze the long-term results after Bentall operation using the stentless Shelhigh No-React (NR)-2000 bio-root prosthesis.Material: From 2004 to 2008, 26 consecutive, nonselected patients (mean age at surgery: 67 ± 9 years) underwent a Bentall operation using a stentless Shelhigh valved conduit at our institution. Mean preoperative Logistic-EuroSCORE was 17.1 ± 12.9. The mean size of the aortic root was 53.2 ± 5 mm. The mean preoperative ejection fraction was 55 ± 7.4%. Three patients had a bicuspid valve. One patient with acute endocarditis and one patient with type A aortic dissection were operated on an emergency. Three patients (11.54%) had a previous cardiac operation. The Button-Bentall technique was used in all cases. Seven patients (26.92%) received an associated procedure. The mean size of the implanted prosthesis was 26.1 ± 2.2. Follow-up ranged between 6 and 174 months (mean 93.4 ± 59.1 months).Primary endpoints consisted of early and late mortality, freedom from acute endocarditis, freedom from structural valve deterioration, and freedom from valverelated-reoperation.Results: Two patients died in hospital, while 10 patients died during follow-up time, of which three for cardiac causes (12.5%). Overall survival probability was 52.9% at 15 years. Freedom from acute endocarditis was 95.7% at 5 and 15 years. Freedom from severe aortic incompetence due to structural deterioration was 100% at 5 and 10 years, 90.9% at 15 years. The mean aortic gradient at follow-up was 11.4 ± 5 mm Hg.Freedom from valve-related reoperation was 100% at 5 and 10 years, 90.9% at 15 years. Conclusions: In our experience, Bentall's operation using the Shelhigh NR-2000 stentless bio-conduit provided satisfactory early and long-term results. However, our findings are not consistent with unfavorable long-term outcomes following the implantation of this device reported by other authors. K E Y W O R D S aortic root, aortic valve, biological graft How to cite this article: Stefanelli G, Pirro F, Macchione A, Bellisario A, Weltert L. Long-term follow-up after Bentall operation using a stentless Shelhigh NR-2000 bio-conduit. J Card Surg. 2020;35:988-995.

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Freestyle stentless bioprosthesis for aortic valve therapy: 17-year clinical results

Abstract: Long-term results after aortic valve replacement with stentless biological prostheses compare favorably with those obtained with stented bioprostheses.

Cited by 10 publications

References 17 publications

Outcomes of Patients after Implantation of the Pericardial All-Biological Valve No-React Aortic Conduit (BioIntegral) for Root Replacement in Complex Surgical Procedures

Outcomes of Patients after Implantation of the Pericardial All-Biological Valve No-React Aortic Conduit (BioIntegral) for Root Replacement in Complex Surgical Procedures

Freestyle Aortic Root Prosthesis in Combination with Aortic Replacement and Open Anastomosis: A Retrospective Analysis.

Long‐term follow‐up after Bentall operation using a stentless Shelhigh NR‐2000 bio‐conduit

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