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John Pepper - One of the best experts on this subject based on the ideXlab platform.
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Abstract 4785: Comparison Of Long-term Clinical Outcomes Following Aortic Valve Replacement With Homografts And Porcine Stentless Valves
Circulation, 2008Co-Authors: Amit Patel, Sabine Bleiziffer, Yasir Abu-omar, Anila Mehta, Darren H. Freed, Ahmad Y. Sheikh, Thanos Athanasiou, John PepperAbstract:The porcine Stentless Valve was designed to emulate the hemodynamic performance of the homograft. Early outcomes using either surgical option have been similar. However, long-term outcomes remain t...
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longitudinal study of the profile and predictors of left ventricular mass regression after Stentless aortic Valve replacement
The Annals of Thoracic Surgery, 2008Co-Authors: Panagiotis Theodorou, M Henein, Ines Sousa, Hutan Ashrafian, Themis Chamageorgakis, Alison Duncan, Peter J Diggle, John PepperAbstract:BACKGROUND: The aim of this study was to evaluate the long-term profile and determine the factors that would influence the effect and rate of ventricular mass regression with time after aortic Valve replacement with a Stentless or a homograft Valve. METHODS: We studied 300 patients during a 10-year period with at least a year of follow-up with a total of 1,273 serial echocardiographic measurements. Left ventricular mass was calculated from M-mode recordings and indexed to body surface area. Longitudinal data analysis was performed using a linear mixed effects model. RESULTS: The mean age (+/- standard deviation) was 65 (+/-14) years, consisting of 216 (72%) males. A Stentless Valve was implanted in 156 (52%), and a homograft in 144 (48%). The median time (interquartile range) to follow-up was 4.7 (2.8 to 6.6) years. The greatest rate of left ventricular mass regression occurred in the first year after surgery. On multivariable modeling, independent predictors of left ventricular mass were Valve size (p = 0.011), left ventricular function (moderate impairment, p = 0.418; severe impairment, p = 0.011), and baseline left ventricular mass (middle tercile, p < 0.001; highest tercile, p < 0.001). Only baseline ventricular mass influenced the rate of subsequent left ventricular mass regression; the greatest rate of regression occurred in patients with the highest baseline values of ventricular mass (p < 0.001). CONCLUSIONS: The greatest rate of left ventricular mass regression occurs in the first year with baseline left ventricular mass as the strongest predictor and the only identified variable that influenced the rate of left ventricular mass regression.
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perioperative assessment of aortic homograft toronto Stentless Valve and stented Valve in the aortic position
The Annals of Thoracic Surgery, 1995Co-Authors: Derek G Gibson, Magdi H Yacoub, John PepperAbstract:We investigated aortic Valve hemodynamic performance and perioperative left ventricular function in 50 patients (mean [± SD] age, 64 ± 9 years; 34 men, 16 women) undergoing elective aortic Valve replacement, using an aortic homograft (n = 20), a Toronto Stentless porcine Valve (n = 20), or a stented bioprosthesis (n = 10), by transesophageal echocardiography combined with highfidelity cavity pressure recordings and thermodilution cardiac output measurements. Thirty-nine patients had aortic stenosis; 11 had predominant regurgitation. Thirteen patients with concomitant coronary artery stenosis underwent grafting. Left ventricular mass index in all patients was 280 ± 110 g/m 2 . The transvalvular pressure drop and energy consumption were significantly higher with stented than Stentless Valves (5 with aortic homograft and 11 with Toronto Valve, with matched age and Valve size; 20 ± 12 versus 3 ± 9 mm Hg; 21% ±13% versus 8% ± 8%, both p p > 0.05), although the Toronto Valves (normalized to body surface area) were larger than the aortic homografts (14.4 ± 1.9 versus 12.6 ± 1.8 mm/m 2 , p
Mark F Obrien - One of the best experts on this subject based on the ideXlab platform.
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cryolife o brien Stentless Valve 10 year results of 402 implants
Faculty of Built Environment and Engineering, 2005Co-Authors: Mark F Obrien, Michael A H Gardner, Bruce Garlick, Homayoun Jalali, Julie A Gordon, Sarah L Whitehouse, Wendy E Strugnell, Richard SlaughterAbstract:Background This truly Stentless porcine Valve is composite, without Dacron and implanted supra-annularly. Ten year analysis with magnetic resonance imaging is presented. Methods From 1992 to 2002, 402 patients (mean 73.5 yrs) had aortic Valve replacement. Associated procedures were required in 252 patients (63%). Serial echoes provided 1340 studies. Clinical follow-up was 100%. Magnetic Resonance Imaging focused on aortic annulus extensibility. Results The 30 day mortality was 0.99% (4 deaths). Morbidity comprised (a) thromboembolism (40 patients including 18 patients with permanent strokes); (b) endocarditis (nine patients); (c) re-operation (nine patients) - peri-prosthetic leak (2), endocarditis (5), technical needle damage (1) and structural degeneration (1). Of 402 Valves over 10 years, five Valves were explanted, one only for structural failure. Except for endocarditis (2), no late deaths (69 pts, 1.5 months – 5.7 yrs) were Valve related. Echocardiography demonstrated low gradients with good orifice areas, excellent ventricular regression (p = 0.0001 pre and post-operative comparisons) and late incompetence - mild (45 pts) and moderate (nine pts). No living patient has severe incompetence. Magnetic Resonance Imaging demonstrated the annulus ‘expanding and relaxing’ throughout the cardiac cycle, the mean increase in cross-sectional area being 37%, resembling normal aortic root dynamics. Conclusion Elderly patients received this hemodynamically acceptable Valve with its simple, supra-annular implantation and satisfactory mid-term morbid-free lifestyle to 10 years maximum follow-up. With only one structural failure, restoration of Valve annular extensibility may have a favourable influence on long-term durability.
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cryolife o brien Stentless Valve 10 year results of 402 implants
The Annals of Thoracic Surgery, 2005Co-Authors: Mark F Obrien, Michael A H Gardner, Bruce Garlick, Homayoun Jalali, Julie A Gordon, Sarah L Whitehouse, Wendy E Strugnell, Richard SlaughterAbstract:Background This truly Stentless porcine Valve is composite, without Dacron, and implanted supra-annularly. Ten-year analysis with magnetic resonance imaging is presented. Methods From 1992 to 2002, 402 patients (mean 73.5 years) had aortic Valve replacement. Associated procedures were required in 252 patients (63%). Serial echoes provided 1340 studies. Clinical follow-up was 100%. Magnetic resonance imaging focused on aortic annulus extensibility. Results The 30-day mortality was 0.99% (4 deaths). Morbidity comprised thromboembolism (40 patients including 18 patients with permanent strokes); endocarditis (9 patients); and reoperation (9 patients [periprosthetic leak, 2; endocarditis, 5; technical needle damage, 1; and structural degeneration, 1]). Of 402 Valves more than 10 years, five Valves were explanted, one only for structural failure. Except for endocarditis (2 patients), no late deaths (69 patients, 1.5 months to 5.7 years) were Valve related. Echocardiography demonstrated low gradients with good orifice areas, excellent ventricular regression ( p = 0.0001 preoperative and postoperative comparisons) and late incompetence (mild in 45 patients and moderate in 9 patients). No living patient has severe incompetence. Magnetic resonance imaging demonstrated the annulus ‘expanding and relaxing' throughout the cardiac cycle, the mean increase in cross-sectional area being 37%, resembling normal aortic root dynamics. Conclusions Elderly patients received this hemodynamically acceptable Valve with its simple, supra-annular implantation and satisfactory mid-term morbid-free lifestyle to 10 years maximum follow-up. With only one structural failure, restoration of Valve annular extensibility may have a favorable influence on long-term durability.
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multicenter study of Stentless Valve replacement in the small aortic root
The Journal of Thoracic and Cardiovascular Surgery, 1999Co-Authors: Ulrik Hvass, George M Palatianos, Romeo Frassani, Cesare Puricelli, Mark F ObrienAbstract:Abstract Objective: A clinical study was conducted to evaluate the results of Stentless porcine Valves in patients with a small aortic root (19- and 21-mm aortic anulus). Methods: Of 567 patients, from 4 surgical institutions, 171 patients (30.1%) had a small aortic root, comprising 163 cases with calcified aortic stenosis and 8 cases with predominant valvular insufficiency. Sixty patients had associated mitral or coronary lesions. Mean age was 72 ± 4.2 years. Forty-seven patients with a small aortic root had a 19-mm anulus, and 124 patients had a 21-mm anulus. The body surface area was, respectively, 1.55 ± 0.2 m 2 and 1.78 ± 0.45 m 2 . Hemodynamic evaluation of the Stentless Valve comprised serial measures of mean gradients, effective orifice area, and left ventricular mass reduction. Complication rates for secondary events were evaluated over a 6-year period. Results: The hospital mortality rate was 3.5%. The mean gradients after the first year were 9 ± 2 mm Hg and 6 ± 1.7 mm Hg in patients with a 19-mm and a 21-mm anulus, respectively. Effective orifice area was 1.45 ± 0.3 cm 2 and 1.72 ± 0.4 cm 2 . Gradients and surfaces remained stable throughout the study period. Aortic regurgitation was zero to trace. Left ventricular mass at discharge and at 1 year were, respectively, 296 ± 127 g and 215 ± 102 g for patients with a 19-mm anulus and 281 ± 75 g and 236 ± 15 g for patients with a 21-mm anulus. Conclusions: Stentless Valves are a suitable device for elderly patients with small aortic roots, which leave only mild residual obstruction. (J Thorac Cardiovasc Surg 1999;117:267-72)
Stephen Westaby - One of the best experts on this subject based on the ideXlab platform.
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In vivo hemodynamic characteristics of porcine Stentless aortic Valves.
Seminars in Thoracic and Cardiovascular Surgery, 2001Co-Authors: Stephen WestabyAbstract:The objective of this study was to elucidate the relationship of aortic pressure gradient (mPG) and effective orifice area (EOA) with mean systolic flow rate of left ventricle in patients who received a Stentless aortic Valve. Two hundred thirteen patients (age: 73 +/- 6 years, 123 men and 90 women) who received a Freestyle Stentless Valve in subcoronary position for aortic Valve diseases were studied. EOA, mPG, and systolic aortic flow rate were determined by Doppler echocardiography at 1 and 20 months after implant. With follow-up, there was a 13% increase in EOA and a 30% decrease in mPG, both P
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Aortic root geometry and Stentless porcine Valve competence.
Seminars in Thoracic and Cardiovascular Surgery, 1999Co-Authors: Stephen WestabyAbstract:The goal of this study was to characterize medium-term changes in aortic root geometry after Stentless aortic Valve replacement, the relationship between aortic sinotubular junction and the competence of Stentless Valves. A total of 205 consecutive patients (mean age 73+/-6 years; 120 men, 85 women) received a Freestyle Stentless porcine aortic Valve and were studied prospectively by echocardiography from 1 week to 5 years. Internal diameters of outflow tract, annulus, sinus, sinotubular junction, and ascending aortic root were measured at early ejection and indexed to Stentless Valve size. The degree of Stentless Valve regurgitation was semiquantified by color Doppler echocardiography. A total of 701 echocardiographic studies were obtained and analyzed; 73% showed a fully competent Stentless Valve (nAR) and 13% and 14%, respectively, showed a trivial (tAR) or mild (mAR) regurgitation. Sinotubular junction of tAR or mAR was significantly greater than that of nAR (111+/-1.9, 117+/-2.2 vs. 104+/-1.0, percentage of Valve size, P
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Valve replacement with a Stentless bioprosthesis versatility of the porcine aortic root
The Journal of Thoracic and Cardiovascular Surgery, 1998Co-Authors: Stephen Westaby, Takahiro Katsumata, Ahmed A Arifi, Peter C BraidleyAbstract:Abstract Objective: Stentless Valves convey important hemodynamic benefits but are used selectively depending on aortic root structure. The Freestyle Valve (Medtronic, Inc, Minneapolis, Minn) is a versatile device that can be implanted by different methods depending on operating conditions. We aimed to demonstrate that a Stentless Valve could be used in every patient without increased risk of morbidity or mortality. We documented the effects of this Valve on clinical outcome and left ventricular mechanics. Methods: The Freestyle Valve was implanted by the modified subcoronary method into 200 consecutive unselected patients who received a tissue Valve in the aortic position and by root replacement in 2. Forty-three percent were older than 75 years. Forty percent underwent coronary bypass. Detailed clinical and echocardiographic follow-up (Food and Drug Administration protocol) was used out to 3 years. Results: Mean ischemic time was 43 ± 6 minutes for isolated aortic Valve replacement and 63 ± 14 minutes with concomitant procedures. Thirty-day mortality was 6%, none of the deaths being Valve related. Hemodynamic function improved progressively with falling Valve gradients and increased effective orifice areas. Left ventricular mass fell within normal limits over 2 years, but at 3 years there was a non-Valve-related upswing. No instances of Valve thrombosis, hemolysis, or paravalvular leak were noted. Less than 5% had mild to moderate aortic regurgitation. Conclusions: The Freestyle Valve can be used in virtually every patient with aortic Valve disease and provides superlative hemodynamic outcome. Hospital mortality and morbidity are similar to those reported for stented Valves in an elderly population. (J Thorac Cardiovasc Surg 1998;116:477-84)
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left ventricular remodelling and improvement in freestyle Stentless Valve haemodynamics
European Journal of Cardio-Thoracic Surgery, 1997Co-Authors: Stephen Westaby, D G Gibson, R Pillai, David P TaggartAbstract:OBJECTIVE: To assess how left ventricular (LV) hypertrophy, geometry and function change after Stentless aortic Valve replacement for aortic stenosis, and to elucidate the physiological mechanism of the improvement in Stentless Valve haemodynamics. METHODS: 81 patients with aortic stenosis (age 75 +/- 6 years, 47 male) underwent aortic Valve replacement (plus CABG in 33 patients) with a Freestyle Stentless porcine Valve (mean size 23 +/- 2 mm). They were prospectively investigated by Doppler echocardiography at 2 weeks, 3-6, 12, and 24 months after operation. Two hundred and forty-six echocardiograms were obtained and analysed. Aortic Valve performance was assessed from its effective orifice area (EOA), the transvalvular increase in mean flow velocity (delta mV), the deceleration time of aortic flow velocity, and mean pressure drop (mPG). LV hypertrophy was assessed from LV mass index; LV geometry, from the ratio of wall thickness to the radius (T/R ratio) and LV function, from stroke volume index (LVSVI) and myocardial stroke work (SW). RESULTS: By 2 years after operation, LV mass index had fallen from 162 +/- 64 to 109 +/- 36, g/m2, and T/R ratio from 0.61 +/- 0.25 to 0.43 +/- 0.10. LVSVI increased from 29.4 +/- 10 to 42 +/- 17, ml/m2, and myocardial SW from 3.1 +/- 1.6 to 5.2 +/- 2.2, mJ/cm3 (all P < 0.001 by ANOVA), while LV outflow tract diameter remained unchanged. At the same time, Stentless Valve EOA increased from 1.59 +/- 0.75 to 2.2 +/- 0.72, cm2, and delta mV (from 82 +/- 31 to 49 +/- 24, cm/s) and mPG (from 9.7 +/- 5.0 to 5.2 +/- 3.7 mmHg) both fell significantly (all P < 0.001 by ANOVA): as the deceleration time of aortic flow velocity increased from 153.6 +/- 64.1 to 202.7 +/- 37.6 ms (P < 0.001 by ANOVA). CONCLUSION: After Stentless aortic Valve replacement, LV mass index and wall thickness both fall towards normal, and myocardial stroke work increases. These ventricular remodelling processes are accompanied by a more physiological flow jet at Valve cusp level, which permits a greater stroke volume to be ejected with a smaller transvavular velocity increase, so that effective orifice area increases.
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Left ventricular remodelling and improvement in Freestyle Stentless Valve haemodynamics
European Journal of Cardio-Thoracic Surgery, 1997Co-Authors: Stephen Westaby, R Pillai, Gibson Dg, David P TaggartAbstract:Objective: To assess how left ventricular (LV) hypertrophy, geometry and function change after Stentless aortic Valve replacement for aortic stenosis, and to elucidate the physiological mechanism of the improvement in Stentless Valve haemodynamics. Methods: 81 patients with aortic stenosis (age 75 ± 6 years, 47 male) underwent aortic Valve replacement (plus CABG in 33 patients) with a Freestyle Stentless porcine Valve (mean size 23 ± 2 mm). They were prospectively investigated by Doppler echocardiography at 2 weeks, 3-6, 12, and 24 months after operation. Two hundred and forty-six echocardiograms were obtained and analysed. Aortic Valve performance was assessed from its effective orifice area (EOA), the transvalvular increase in mean flow velocity (ΔmV), the deceleration time of aortic flow velocity, and mean pressure drop (mPG). LV hypertrophy was assessed from LV mass index; LV geometry, from the ratio of wall thickness to the radius (T/R ratio) and LV function, from stroke volume index (LVSVI) and myocardial stroke work (SW). Results: By 2 years after operation, LV mass index had fallen from 162 ± 64 to 109±36, g/m 2 , and T/R ratio from 0.61±0.25 to 0.43±0.10. LVSVI increased from 29.4±10 to 42±17, ml/m 2 , and myocardial SW from 3.1±1.6 to 5.2±2.2, mJ/cm 3 (all P < 0.001 by ANOVA), while LV outflow tract diameter remained unchanged. At the same time, Stentless Valve EOA increased from 1.59±0.75 to 2.2±0.72, cm 2 , and ΔmV (from 82 ± 31 to 49±24, cm/s) and mPG (from 9.7±5.0 to 5.2±3.7 mmHg) both fell significantly (all P < 0.001 by ANOVA); as the deceleration time of aortic flow velocity increased from 153.6±64.1 to 202.7±37.6 ms (P < 0.001 by ANOVA). Conclusion: After Stentless aortic Valve replacement, LV mass index and wall thickness both fall towards normal, and myocardial stroke work increases. These ventricular remodelling processes are accompanied by a more physiological flow jet at Valve cusp level, which permits a greater stroke volume to be ejected with a smaller transvavular velocity increase, so that effective orifice area increases.
Olaf Stanger - One of the best experts on this subject based on the ideXlab platform.
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Challenges and Lessons from Preoccupation with the Stentless Aortic Valve Prosthesis Concept
Surgical Management of Aortic Pathology, 2019Co-Authors: Olaf StangerAbstract:The third-generation bovine pericardium Freedom SOLO (FS) Stentless Valve emerged in 2004 as a modified version of the Pericarbon Freedom Stentless Valve and as a very attractive alternative to stented bioprostheses. The design, choice of tissue, and anticalcification treatment fulfill most, if not all, requirements for an ideal Valve substitute that allows imitation of the native healthy Valve through unrestricted adaption to the patient’s anatomy, reproducing a normal Valve/root complex. However, despite hemodynamic performance superior to stented Valves superior durability, freedom from structural Valve deterioration, and nonstructural failure has not been proven as expected. Optimal performance and freedom from structural Valve deterioration depend on correct sizing and perfect symmetric implantation, to ensure low leaflet stress. Any malpositioning can lead to tissue fatigue over time.
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pitfalls and premature failure of the freedom solo Stentless Valve
European Journal of Cardio-Thoracic Surgery, 2015Co-Authors: Olaf Stanger, H T Tevaearai, Thierry Carrel, Irina Bleuel, Sylvia Reineke, Yara Banz, Gabor Erdoes, Volkhard Gober, Lars EnglbergerAbstract:OBJECTIVES: This study reports a series of pitfalls, premature failures and explantations of the third-generation Freedom SOLO (FS) bovine pericardial Stentless Valve. METHODS: A total of 149 patients underwent aortic Valve replacement using the FS. Follow-up was 100% complete with an average observation time of 5.5 ± 2.3 years (maximum 8.7 years) and a total of 825 patient-years. Following intraoperative documentation, all explanted Valve prostheses underwent histological examination. RESULTS: Freedom from structural Valve deterioration (SVD) at 5, 6, 7, 8 and 9 years was 92, 88, 80, 70 and 62%, respectively. Fourteen prostheses required explantation due to Valve-independent dysfunction (n= 5; i.e. thrombus formation, oversizing, aortic dilatation, endocarditis and suture dehiscence) or Valve-dependent failure (acute leaflet tears, n= 4 and severe stenosis, n= 5). Thus, freedom from explantation at 5, 6, 7, 8 and 9 years was 95, 94, 91, 81 and 72%, respectively. An acute vertical tear along the non-coronary/right coronary commissure to the base occurred at a mean of 6.0 years (range 4.3–7.3 years) and affected size 25 and 27 prostheses exclusively. Four FS required explantation after a mean of 7.5 years (range 7.0–8.3 years) due to severe functional stenosis and gross calcification that included the entire aortic root. CONCLUSIONS: The FS Stentless Valve is safe to implant and shows satisfying mid-term results in our single institution experience. Freedom from SVD and explantation decreased markedly after only 6–7 years, so that patients with FS require close observation and follow-up. Exact sizing, symmetric positioning and observing patient limitations are crucial for optimal outcome.
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the freedom solo pericardial Stentless Valve single center experience outcomes and long term durability
The Journal of Thoracic and Cardiovascular Surgery, 2015Co-Authors: Olaf Stanger, Thierry Carrel, Irina Bleuel, Sylvia Reineke, Volkhard Gober, Lars Englberger, Fabian Gisler, Brigitta Gahl, Thierry Aymard, H T TevaearaiAbstract:Abstract Objectives To report our institutional experience and long-term results with the Freedom Solo bovine pericardial Stentless bioprosthesis (Sorin Group, Saluggia, Italy). Methods Between January 2005 and November 2009, 149 patients (mean age, 73.6 ± 8.7 years; 68 [45.6%] female) underwent isolated (n = 75) or combined (n = 74) aortic Valve replacement (AVR) using the Solo in our institution. Follow-up was 100% complete with an average follow-up time of 5.9 ± 2.6 years (maximum, 9.6 years) and a total of 885.3 patient years. Results Operative (30-day) mortality was 2.7% (1.3% for isolated AVR [n = 1] and 4.0% for combined procedures [n = 3]). All causes of death were not Valve-related. Preoperative peak (mean) gradients of 74.2 ± 23.0 mm Hg (48.6 ± 16.3 mm Hg) decreased to 15.6 ± 5.4 mm Hg (8.8 ± 3.0 mm Hg) after AVR, and remained low for up to 9 years. The postoperative effective orifice area was 1.6 ± 0.57 cm 2 , 1.90 ± 0.45 cm 2 , 2.12 ± 0.48 cm 2 , and 2.20 ± 0.66 cm 2 for the Valve sizes 21, 23, 25, and 27, respectively, with absence of severe prosthesis-patient mismatch and 0.7% (n = 1) experienced moderate prosthesis-patient mismatch. During follow-up, 26 patients experienced structural Valve deterioration (SVD) and 14 patients underwent explantation. Kaplan-Meier estimates for freedom from death, explantation, and SVD at 9 years averaged 0.57 (range, 0.47-0.66), 0.82 (range, 0.69-0.90), and 0.70 (range, 0.57-0.79), respectively. Conclusions The Freedom Solo Stentless aortic Valve is safe to implant and shows excellent early and midterm hemodynamic performance. However, SVD was observed in a substantial number of patients after only 5-6 years and the need for explantation increased markedly, suggesting low durability.
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the freedom solo bovine pericardial Stentless Valve
Research Reports in Clinical Cardiology, 2014Co-Authors: Olaf Stanger, H T Tevaearai, Thierry CarrelAbstract:Abstract: The third-generation bovine pericardium Freedom SOLO (FS) Stentless Valve emerged in 2004 as a modified version of the Pericarbon Freedom Stentless Valve and as a very attractive alternative to stented bioprostheses. The design, choice of tissue, and anticalcification treatment fulfill most, if not all, requirements for an ideal Valve substitute. The FS combines the single-suture, subcoronary implantation technique with the latest-generation bovine pericardial tissue and novel anticalcification treatment. The design allows imitation of the native healthy Valve through unrestricted adaption to the patient's anatomy, reproducing a normal Valve/root complex. However, despite hemodynamic performance superior to stented Valves, we are approaching a critical observation period as superior durability, freedom from structural Valve deterioration, and nonstructural failure has not been proven as expected. However, optimal performance and freedom from structural Valve deterioration depend on correct sizing and perfect symmetric implantation, to ensure low leaflet stress. Any malpositioning can lead to tissue fatigue over time. Furthermore, the potential for better outcomes depends on optimal patient selection and observance of the limitations for the use of Stentless Valves, particularly for the FS. Clearly, Stentless Valve implantation techniques are less reproducible and standardized, and require surgeon-dependent experience and skill. Regardless of whether or not Stentless Valve durability surpasses third-generation stented bioprostheses, they will continue to play a role in the surgical repertoire. This review intends to help practitioners avoid pitfalls, observe limitations, and improve patient selection for optimal long-term outcome with the attractive FS Stentless Valve.
Lars Englberger - One of the best experts on this subject based on the ideXlab platform.
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pitfalls and premature failure of the freedom solo Stentless Valve
European Journal of Cardio-Thoracic Surgery, 2015Co-Authors: Olaf Stanger, H T Tevaearai, Thierry Carrel, Irina Bleuel, Sylvia Reineke, Yara Banz, Gabor Erdoes, Volkhard Gober, Lars EnglbergerAbstract:OBJECTIVES: This study reports a series of pitfalls, premature failures and explantations of the third-generation Freedom SOLO (FS) bovine pericardial Stentless Valve. METHODS: A total of 149 patients underwent aortic Valve replacement using the FS. Follow-up was 100% complete with an average observation time of 5.5 ± 2.3 years (maximum 8.7 years) and a total of 825 patient-years. Following intraoperative documentation, all explanted Valve prostheses underwent histological examination. RESULTS: Freedom from structural Valve deterioration (SVD) at 5, 6, 7, 8 and 9 years was 92, 88, 80, 70 and 62%, respectively. Fourteen prostheses required explantation due to Valve-independent dysfunction (n= 5; i.e. thrombus formation, oversizing, aortic dilatation, endocarditis and suture dehiscence) or Valve-dependent failure (acute leaflet tears, n= 4 and severe stenosis, n= 5). Thus, freedom from explantation at 5, 6, 7, 8 and 9 years was 95, 94, 91, 81 and 72%, respectively. An acute vertical tear along the non-coronary/right coronary commissure to the base occurred at a mean of 6.0 years (range 4.3–7.3 years) and affected size 25 and 27 prostheses exclusively. Four FS required explantation after a mean of 7.5 years (range 7.0–8.3 years) due to severe functional stenosis and gross calcification that included the entire aortic root. CONCLUSIONS: The FS Stentless Valve is safe to implant and shows satisfying mid-term results in our single institution experience. Freedom from SVD and explantation decreased markedly after only 6–7 years, so that patients with FS require close observation and follow-up. Exact sizing, symmetric positioning and observing patient limitations are crucial for optimal outcome.
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the freedom solo pericardial Stentless Valve single center experience outcomes and long term durability
The Journal of Thoracic and Cardiovascular Surgery, 2015Co-Authors: Olaf Stanger, Thierry Carrel, Irina Bleuel, Sylvia Reineke, Volkhard Gober, Lars Englberger, Fabian Gisler, Brigitta Gahl, Thierry Aymard, H T TevaearaiAbstract:Abstract Objectives To report our institutional experience and long-term results with the Freedom Solo bovine pericardial Stentless bioprosthesis (Sorin Group, Saluggia, Italy). Methods Between January 2005 and November 2009, 149 patients (mean age, 73.6 ± 8.7 years; 68 [45.6%] female) underwent isolated (n = 75) or combined (n = 74) aortic Valve replacement (AVR) using the Solo in our institution. Follow-up was 100% complete with an average follow-up time of 5.9 ± 2.6 years (maximum, 9.6 years) and a total of 885.3 patient years. Results Operative (30-day) mortality was 2.7% (1.3% for isolated AVR [n = 1] and 4.0% for combined procedures [n = 3]). All causes of death were not Valve-related. Preoperative peak (mean) gradients of 74.2 ± 23.0 mm Hg (48.6 ± 16.3 mm Hg) decreased to 15.6 ± 5.4 mm Hg (8.8 ± 3.0 mm Hg) after AVR, and remained low for up to 9 years. The postoperative effective orifice area was 1.6 ± 0.57 cm 2 , 1.90 ± 0.45 cm 2 , 2.12 ± 0.48 cm 2 , and 2.20 ± 0.66 cm 2 for the Valve sizes 21, 23, 25, and 27, respectively, with absence of severe prosthesis-patient mismatch and 0.7% (n = 1) experienced moderate prosthesis-patient mismatch. During follow-up, 26 patients experienced structural Valve deterioration (SVD) and 14 patients underwent explantation. Kaplan-Meier estimates for freedom from death, explantation, and SVD at 9 years averaged 0.57 (range, 0.47-0.66), 0.82 (range, 0.69-0.90), and 0.70 (range, 0.57-0.79), respectively. Conclusions The Freedom Solo Stentless aortic Valve is safe to implant and shows excellent early and midterm hemodynamic performance. However, SVD was observed in a substantial number of patients after only 5-6 years and the need for explantation increased markedly, suggesting low durability.
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Deleterious outcome of No-React–treated Stentless Valved conduits after aortic root replacement: Why were Warnings ignored?
The Journal of Thoracic and Cardiovascular Surgery, 2008Co-Authors: Thierry Carrel, Florian Schoenhoff, Juerg Schmidli, Mario Stalder, Friedrich S. Eckstein, Lars EnglbergerAbstract:Objective The implantation of a composite graft is the treatment of choice for patients with aortic root disease if the Valve cannot be preserved and the patient is not a suitable candidate for a Ross procedure. Several years ago, the Shelhigh NR-2000C (Shelhigh, Inc, Millburn, NJ) was introduced in Europe. Being a totally biologic conduit and considering the lack of homografts, the graft seemed an ideal conduit for patients with destructive endocarditis, as well as for older patients who were not suitable candidates for oral anticoagulation. Methods From 2001 until 2006, the Shelhigh NR-2000C Stentless Valved conduit was implanted in 115 patients for various aortic root pathologies. The conduit consists of a bovine pericardial straight graft with an incorporated porcine Stentless Valve. Aortic root repair was performed during standard cardiopulmonary bypass and mild hypothermia in the majority of patients. Deep hypothermic circulatory arrest combined with selective antegrade cerebral perfusion was used when the repair extended into the arch. Results Seven patients with uncomplicated early outcome presented with unexpected sudden disastrous findings at the level of the aortic root, although 1-year follow-up computed tomographic scans were normal. Four of these patients underwent emergency operations because of desintegration of the graft, along with rupture of the aortic root. Retrospectively, the main findings were persistent fever or subfebrility over months and a halo-like enhancement on computed tomographic scans. Extensive microbiologic examinations were performed without finding a causative organism. Conclusion The use of the Shelhigh aortic Stentless conduit can no longer be advocated, and meticulous follow-up of patients in whom this device has been implanted has to be recommended.
