Stentless Aortic Bioprosthesis Research Articles

Freestyle Aortic Bioprostheses in Patients 60 Years old and Younger

Evaluate outcomes of the Freestyle stentless aortic bioprosthesis in patients 60 years old and younger. All patients, 60 years old and younger, between January 1, 1998 to December 31, 2015 who underwent implantation of a Freestyle aortic valve at a single institution were reviewed. Medical records and telephone interviews were utilized for data collection. 515 patients were identified with an average age of 51.3 years. Mean follow up was 11.1 years. 225 full root replacements and 290 subcoronary implants were performed. Overall survival, including patients with concomitant procedures, at 15 years was 63.7% (95% CI 58.3-68.5). Isolated subcoronary implants (58%,167/290) had a 15-year survival of 71.6% (95% CI 62.6-78.7) vs 78.4% (95% CI 69.7, 84.9) for isolated root replacements (63%,141/225) which was not statistically significant (P=0.397). No significant difference in operative SVD at 15 years occurred between full root replacements 37.6% (95% CI 27.2-50.2) vs subcoronary implants 39.4% (95% CI31.1, 49.0). 110 patients required reoperation solely for intrinsic SVD. 93% (102/110) failed due to aortic insufficiency. Of reoperative interventions for SVD, 37% (41/110) of patients required urgent reoperation and 4.5% (5/110) required emergent reoperation. Pseudoaneurysms developed in six of the full root replacements. Freestyle aortic valves have a high rate of acute failure requiring urgent or emergent reintervention in patients 60 years old and younger. This has led our group to shift practice away from their implantation.

Transesophageal Evaluation of Reconstructive Surgery for Aortic Valve Stenosis

BACKGROUND: With transesophageal echocardiography (TEE), were evaluated morphological characteristics and early hemodynamic parameters of stentless three leaflets pericardial patch in patients with aortic stenosis (AS) undergoing aortic valve (AV) surgery.
 AIM: The aim of the study was to point the importance of two-dimensional and three-dimensional TEE imaging intra and early postoperatively.
 METHODS: At Zan Mitrev Clinic, 2002–2020, were included 377 patients following the actual guidelines of European Society of Cardiology for valvular disease, whereas patients with dilatation of aortic annulus, rheumatoid arthritis, and chronic program on hemodialysis were excluded from the study. Instead of using a standard prosthesis, we made a reconstructive surgery implanting three new created leaflets using bovine/equine pericardium by replacing destroyed valve cusps. Leaflets were implanted separately, using continuous sutures with two supported stitches and that is how real stentless AV without any stent or sowing ring was created. Intraoperative and post-operative TEE was performed.
 RESULTS: 377 pts with aortic valvular disease (211–56% male, and 166–44% female; 82–21, 75% with AS, 32–8, 49% with aortic insufficiency, and 263–69, 76% with combined stenosis and insufficiency) were included in the study. Post-operative TEE showed aortic morphology close to normal AV, average pressure gradient was 8 mmHg. 121 pts got a combination with aortocoronary bypass (2.3 grafts per pts). 4 patients were re-operated. Mortality rate was 12.46% (44 pts). Follow-up period was 18 years.
 CONCLUSIONS: Real stentless aortic bioprosthesis is with a close morphology and hemodynamic parameters as a normal valve. TEE such as tool for assessment of AV morphology, anatomy of aortic root, pre-, and intra-operative plays a pivotal role in guiding case selection, surgical planning, and in evaluating procedural success.

Long-term follow-up of the Shelhigh™ superstentless bioprosthesis aortic valve and valved conduit in a monocentric experience.

The Shelhigh™ SuperStentless (Shelhigh, INC., Union, NJ, USA) is a stentless aortic valve bioprosthesis and aortic root valved conduit. In 2007, this device was recalled by FDA due to malfunction, and subsequently reintegrated by BioIntegral Surgical™ Few data are available over late durability of this device. We performed a long-term follow-up of Shelhigh™ devices implanted at our center. Between 2002 and 2007, 44 patients underwent aortic valve replacement with a Shelhigh™ device (40 aortic valve bioprosthesis and 4 valved conduit). We performed a clinical and echocardiographic follow-up (9.2 years±4.3). Standardized definitions of valve-related events were adopted. At discharge, maximum and mean aortic gradients averaged 36.1±11.3 and 21.0±6.8 mmHg, respectively. The 30-days mortality was 2.3%. Over the follow-up period, 29 patients died (65.9%); 2 deaths were valve related. Overall survival at 1, 5 and 10 years was 97.7%, 85.8% and 54% respectively. At last echocardiography, average transvalvular gradients had remained globally stable in the population (33.6±12 and 20.4±10.5 mmHg). Eight (19%) structural valve deterioration (SVD) events were reported. Two (5%) non-structural valve dysfunction (NSVD) events occurred (periprosthetic leak). Two (5%) infectious endocarditis events and two (5%) valve thromboses were also deplored. Three (7%) patients required re-operation (2 due to SVD and 1 due to endocarditis). The immediate hemodynamic performance of the Shelhigh™ aortic bioprostheses was unexpectedly suboptimal. Despite this, hemodynamic performance remained stable over time. Patients survival at follow-up was satisfactory, however, continued surveillance is necessary.

Long Term Outcomes of Freestyle Stentless Aortic Bioprosthesis: A Single Center Experience.

The study is presenting our long-term clinical results after freestyle stentless aortic root bioprosthesis replacement in patients with severe aortic insufficiency with ascending aortic aneurysm. Seventy-seven patients with ascending aortic aneurysms and aortic valve insufficiency underwent a total root replacement procedure using a stentless "Freestyle" valve (Medtronic Inc., Minneapolis, Minnesota). There were 50 (64.9%) men and 27 (35.1%) women. Mean age was 68.7 ± 11.1 years. The surgical procedure used a complete root replacement. Concomitant procedures included coronary artery bypass grafting in 15 (19.5%) patients. The mean cardiopulmonary bypass time was 130.3 ± 26.4 minutes and total aortic cross clamp time was 99.5 ± 23.6 minutes. Hospital mortality was 2.6%. The median follow-up time was 11.2 years. The 5- and 10-years freedom from aortic valve reoperation were 97.4 ± 1.2% and 93.4 ± 4.9%, respectively. During 10 years follow up, there were 14 late deaths; 4 deaths were cardiac, and 10 deaths were noncardiac. Valve-related deaths were attributable to thromboembolism in 1 patient, endocarditis in 2 patients, and congestive heart failure in 1 patient. The freestyle stentless aortic root bioprosthesis offered good clinical outcomes, in terms of survival and structural valve deterioration. The Freestyle valve is a viable option for use in patients undergoing bioprosthetic aortic valve replacement and expected desire for long-term durability.

OUTCOMES OF STENTLESS BIOPROSTHETIC AORTIC VALVES: THE ALBERTA EXPERIENCE

Stentless aortic bioprostheses have demonstrated hemodynamic benefits including laminar flow and larger effective orifice area. However, data on the long-term performance of this valve design is limited relative to conventional stented bioprostheses. As well, many stentless valves were implanted via full-root replacement, potentially making reoperation more technically demanding and higher risk. Alberta’s two cardiac centres have one of the largest experiences with stentless valves in North America. The objective of this study was to compare stentless and stented bioprostheses to assess long-term outcomes, including results of reoperative surgery. Two large prospectively maintained databases, including the province-wide APPROACH database, were used to create a retrospective consecutive cohort. Patients undergoing bioprosthetic aortic valve replacement (AVR) from January 2002 to March 2014 were included. All operations were performed at the Foothills Medical Centre (Calgary) or the University of Alberta Hospital (Edmonton). Patient characteristics, surgical details and clinical outcomes were compared between stentless and stented valve cohorts. During the timeframe, 3959 Albertans underwent AVR with either stentless (n=1238) or stented (n=2721) bioprotheses. The 2 cohorts were similar overall, though patients in the stentless group were younger (67.0±12.5 vs. 70.8 years; p<0.0001), and had higher incidence of COPD and dyslipidemia. The majority of stentless valves were Medtronic Freestyle porcine prostheses (n=992; 80.1%). Over the 12-year period, there was no difference in survival between the groups. Table 1 outlines reoperative outcomes. During a mean follow-up of 7.9±2.6 vs 5.3±2.4 years (stentless vs stented), there was a similar rate of AVR-related reoperation in both groups (4.3% vs. 8.6%, stentless vs. stented; p=0.32). Both reoperative cohorts demonstrated similar crossclamp times and cardiopulmonary bypass times. There was no difference in perioperative mortality at reoperation (7.6 vs 6.4%, stentless vs. stented; p=0.22). Reoperation in both groups were due to multiple reasons, but most common was structural valve deterioration (Figure 1). This study presents the largest reported cohort of sutureless valve patients. Outcomes suggest no significant difference in survival or rate or reoperation between stented and stentless valves over a 12-year follow-up period. Furthermore, reoperation in patients with stentless valves, though thought to be accompanied with higher technical difficulty and risk, does not demonstrate increases in crossclamp times, cardiopulmonary bypass times, perioperative mortality or all cause mortality. In the future, we hope to both extend the study period to determine differences in incidence of structural valve deterioration together with mechanism of failure.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Stented versus stentless aortic valve replacement in elderly: a systematic review and meta-analysis

Background: Stentless aortic bioprostheses offer improved outcomes and long-term survival over stented aortic bioprostheses in aortic valve replacement (AVR). However, it remains unclear whether this improved outcome can also be demonstrated in elderly patients. This meta-analysis sought to determine whether stentless bioprosthetic valves improve clinical outcomes compared with stented valves in elderly patients undergoing AVR. Methods: A comprehensive search was undertaken among PubMed, Embase, Scopus, and Ovid to identify all randomized and nonrandomized controlled trials available up to March 2017 comparing stentless to stented bioprosthetic valves in elderly patients undergoing AVR. Odds ratios (ORs), weighted mean differences, or standardized mean differences and their 95% confidence intervals (CIs) were analysed. Results: A total of 1,048 patients were analysed and data extracted from six studies were suitable for meta-analysis. Average age was 77 years. The stented group displayed a significantly shorter cardiopulmonary bypass (P&lt;0.0001; 95% CI: 0.424 to 1.05) and aortic cross clamp time (P&lt;0.0001; 95% CI: 0.237 to 0.491) compared to the stentless group. There was no difference in the relative risks of stroke events (P=0.5074). In hospital mortality was significantly lower in the stentless group (P&lt;0.0001). However, there was no difference in the 5-year mortality postoperatively for the two groups (P=0.835). Conclusions: Our results showed that stentless aortic valves resulted in lower in-hospital and similar 5-year mortality compared to stented valves, despite less favourable operative data. They have also had better echocardiographic findings both while in hospital and at 6 months of follow up.

Transcatheter aortic valve-in-valve implantation in failed stentless bioprostheses.

To compare the safety and efficacy of transcathether aortic valve-in-valve implantation (ViV-TAVI) in degenerated stentless bioprostheses with failed stented valves and degenerated native aortic valves. Little is known about ViV-TAVI in degenerated stentless valves. Out of 45 ViV-TAVI procedures reported in the POL-TAVI registry, 20 failed stentless valves were compared with 25 stented prostheses and propensity-matched with 45 native TAVI cases. The mean follow-up was 633 (95% confidence interval [CI], 471-795) days and Valve Academic Research Consortium-2 (VARC-2) definitions were applied. Patients with degenerated stentless valves were younger (65.6, CI 58-73.1 years vs 75.6, CI 72.2-78 [stented] vs 80.1, CI 78.7-81.6 y. [native], P < 0.001). Implantation was required later after surgery (11.5, CI 8-14.9 years) in the stentless cohort as compared with the stented one (6.2, CI 4.7-7.6 years, P = 0.006). ViV-TAVI in the stentless group was also associated with larger amount of contrast (211, CI 157-266 mL vs 135, CI 104-167 mL [stented] vs 132 (119-145) mL [native], P = 0.022). Using VARC-2 composite endpoints, ViV-TAVI in stentless prostheses was characterized by a lower device success (50% vs 76% in stented vs 88.9% in native TAVI, P < 0.001), but comparable early safety up to 30 days (73.7% vs 84% vs 81.8%, respectively, log-rank P = 0.667) and long-term clinical efficacy beyond 30 days (72.2% vs 72% vs 73.8%, respectively, log-rank P = 0.963). Despite technical challenges and a lower device success, ViV-TAVI in stentless aortic bioprostheses achieves similar safety, efficacy, and functional improvement as in stented or degenerated native valves.

Aortic Valve Reoperation After Stentless Bioprosthesis: Short- and Long-Term Outcomes

Limited data are available regarding outcomes for stentless aortic valve reoperation. The reported reoperative mortality has been unacceptably high. Between 1997 and 2017, a retrospective analysis was performed on 143 patients who underwent open aortic valve reoperations for failed stentless aortic valve bioprostheses. We evaluated both short-term and long-term outcomes on this cohort of patients. Bicuspid aortic valve was present in 107 of 143 patients (75%) at the time of the initial Freestyle (Medtronic, Minneapolis, MN) procedure, and 120 of 143 patients (84%) underwent a modified inclusion aortic root replacement procedure. The interval from first operation to reoperation was 9 years (range, 5.4 to 11.8), which was significantly shorter for patients with infectious endocarditis (4.1 years; range, 1.8 to 7.1) compared with patients with structural valvular deterioration (10.4 years; range, 8.1 to 12.4, p < 0.001). The median age at the time of reoperation was 59 years (range, 50 to 67). Aortic valve reoperation was performed for structural valve deterioration in 68% cases compared with 32% for infectious prosthetic valve endocarditis. Concomitant surgery included coronary artery bypass (13%), mitral valve surgery (4%), and ascending aorta and arch replacement (42%). The 30-day and inhospital mortality was 1% and 2%, respectively. The composite outcome including myocardial infarction, stroke, new-onset renal failure on hemodialysis, and operative mortality was 4%. The 5-year and 10-year Kaplan-Meier survival after reoperation for failed stentless valve was 83% (95% confidence interval: 73% to 89%) and 57% (95% confidence interval: 36% to74%). Aortic valve reoperation after stentless valve implantation can be performed with low operative mortality and favorable long-term survival.

Four-dimensional flow MRI of stented versus stentless aortic valve bioprostheses

ObjectivesTo evaluate aortic velocity, wall shear stress (WSS) and viscous energy loss (EL) of stented and stentless bioprostheses using 4D flow MRI 1 year after surgical aortic valve replacement.MethodsFor this cross-sectional study 28 patients with stented (n = 14) or stentless (n = 14) bioprosthesis underwent non-contrast-enhanced 4D-flow MRI at 1.5 T. Analyses included a comparison of velocity, WSS and EL in the ascending aorta during peak systole for both spatially averaged values and a comparison of local differences using per-voxel analysis.ResultsNo significant differences were found in peak and mean velocity (stented vs. stentless: 2.45 m/s vs. 2.11 m/s; p = 0.09 and 0.60 m/s vs. 0.62 m/s; p = 0.89), WSS (0.60 Pa vs. 0.59 Pa; p = 0.55) and EL (10.17 mW vs. 7.82 mW; p = 0.10). Per-voxel analysis revealed significantly higher central lumen velocity, and lower outer lumen velocity, WSS and EL for stentless versus stented prostheses.ConclusionOne year after aortic valve implantation with stented and stentless bioprostheses, velocity, WSS and EL were comparable when assessed for averaged values in the ascending aorta. However, the flow profile described with local analysis for stentless prosthesis is potentially favourable with a significantly higher central velocity profile and lower values for outer lumen velocity, WSS and EL.Key Points• Stentless bioprostheses can be implanted instead of stented aortic valve bioprostheses.• Haemodynamic performance of valve prosthesis can be assessed using 4D flow MRI.• Averaged ascending aorta PSV, WSS and EL are comparable 1 year post-implantation.• Centreline velocity is highest, WSS and EL is lowest for stentless prosthesis.

Current indications for stentless aortic bioprostheses.

The best aortic prostheses have been debated for decades. The introduction of stentless aortic bioprostheses was aimed at improving hemodynamics and potentially the durability of aortic bioprostheses. Despite the good short- and long-term outcomes after implantation of stentless aortic bioprostheses, their use remains limited owing to the technically demanding implantation techniques. Nevertheless, stentless aortic bioprostheses might be of special benefit in certain indications, where they could be a valuable addition to the surgical armamentarium.

Melody valve implantation within freestyle stentless porcine aortic heterograft.

The Melody transcatheter pulmonary valve has been implanted successfully worldwide since its first implant in 2000. The vast majority of these valves have been implanted in pulmonary homografts. In our institution, the most common valve used for pulmonary valve replacement is the Medtronic Freestyle stentless porcine aortic heterograft. We describe our experience implanting the Melody valve within the Freestyle heterograft. Retrospective chart review was performed. Between June 2012 and June 2015, 19 Melody valves were placed within Freestyle heterografts. The most common indication for intervention was pulmonary stenosis. Following pre-stent and Melody valve implantation, right ventricle-to-pulmonary artery gradient decreased from 38.1 ± 12.1 to 10 ± 4.7 mm Hg (P < 0.001), and right ventricular pressure decreased from 61.7 ± 17.8 to 35.6 ± 10.2 mm Hg (P < 0.001). Two procedural adverse events occurred. At median follow-up of 24 months (range 2-48 months), no patients had mean right ventricular outflow tract gradients >30 mm Hg or worse than mild insufficiency. No valve reinterventions have been necessary and no episodes of endocarditis have been observed. The Melody valve can be implanted successfully within a stentless aortic bioprosthesis with good short- and intermediate-term longevity. © 2016 Wiley Periodicals, Inc.

Thrombocytopaenia after aortic valve replacement with stented, stentless and sutureless bioprostheses.

OBJECTIVES Use of the Freedom SOLO (SOLO) stentless aortic bioprosthesis is associated with a unique, and as yet unexplained, observation of postoperative low platelet count. Potential causes include the valve design, tissue and chemicals used for anticalcification treatment. This study compares the platelet response associated with the SOLO to mechanical, stented, sutureless and stentless valve prostheses. METHODS In total, 1587 patients receiving mechanical ATS (n = 199), stented Perimount Magna (Perimount, n = 911), sutureless 3f Enable (n = 34) and Perceval S (n = 48), stentless Pericarbon Freedom (n = 29) or SOLO (n = 366) valves were analysed. The primary end-point was defined as maximum decrease in platelet count expressed as % reduction from baseline within 5 days of aortic valve replacement. RESULTS The smallest decrease in platelets was observed for mechanical valves (44 ± 12%), followed by stented Perimount (50 ± 11%) and sutureless 3f Enable (53 ± 12%) bioprostheses. Compared with these valves, significantly greater reductions in platelets of 61 ± 14%, 60 ± 10% and 64 ± 12% were observed for the Pericarbon Freedom, Perceval S and SOLO, respectively. Multivariable linear regression analysis identified combined procedures, female gender, body surface area, date of operation and longer extracorporeal circulation time, but neither age nor valve size, as significant independent predictors for postoperative low platelet count. After adjustment, Sorin valves caused 13% (95% confidence interval 11-14) greater decrease in platelet counts compared with non-Sorin valves, but were associated with lower need for red blood cell [OR 0.56 (CI 0.41-0.75), P < 0.001] and platelet [OR 0.49 (CI 0.33-0.74), P = 0.001] transfusions. CONCLUSION The Pericarbon Freedom, Perceval S and SOLO bioprostheses are associated with a significantly greater decrease in postoperative platelet count compared with non-Sorin valves. Use of these valves is, however, not associated with excess bleeding complications, suggesting a quantitative, rather than qualitative, transient side-effect on platelets. Our results argue for a cause associated with the anticalcification treatment using homocysteic acid.

Long Term Outcomes Following Freestyle Stentless Aortic Bioprosthesis Implantation: An Australian Experience

The Freestyle stentless bioprosthesis (FSB) has been demonstrated to be a durable prosthesis in the aortic position. We present data following Freestyle implantation for up to 10 years post-operatively and compare this with previously published results. A retrospective cohort analysis of 237 patients following FSB implantation occurred at five Australian hospitals. Follow-up data included clinical and echocardiographic outcomes. The cohort was 81.4% male with age 63.2±13.0 years and was followed for a mean of 2.4±2.3 years (range 0-10.9 years, total 569 patient-years). The FSB was implanted as a full aortic root replacement in 87.8% patients. The 30-day all cause mortality was 4.2% (2.0% for elective surgery). Cumulative survival at one, five and 10 years was 91.7±1.9%, 82.8±3.8% and 56.5±10.5%, respectively. Freedom from re-intervention at one, five and 10 years was 99.5±0.5%, 91.6±3.7% and 72.3±10.5%, respectively. At latest echocardiographic review (mean 2.3±2.1 years post-operatively), 92.6% had trivial or no aortic regurgitation. Predictors of post-operative mortality included active endocarditis, acute aortic dissection and peripheral vascular disease. We report acceptable short and long term outcomes following FSB implantation in a cohort of comparatively younger patients with thoracic aortic disease. The durability of this bioprosthesis in the younger population remains to be confirmed.

Outcomes following freestyle stentless aortic bioprosthesis implantation: The Australian experience up to 10 years

Outcomes following freestyle stentless aortic bioprosthesis implantation: The Australian experience up to 10 years

Aortic valve repair versus replacement for aortic regurgitation: effects on left ventricular remodeling.

Left ventricular (LV) reverse remodeling after aortic valve replacement (AVR) for aortic regurgitation (AR) is associated with superior prognosis. The outcomes of valve-sparing aortic root replacement techniques on LV performance have not been compared with LV reverse remodeling in AVR. The present evaluation compared the extent of long-term LV reverse remodeling in patients with aortic root pathology and/or AR who underwent aortic valve repair (AVr) with patients who underwent AVR. A total of 226 patients (54.7 ± 14.3 years, 63% male) with AR or aortic root pathology who underwent AVr (n = 135) or AVR with the Freestyle® stentless aortic root bioprosthesis [Medtronic, Inc.; Minneapolis, Minnesota] (n = 91) were included in the present retrospective evaluation. LV volumes and ejection fraction were assessed preoperatively, postoperatively (before hospital discharge) and during follow-up. Baseline characteristics were comparable between patient groups, except for higher prevalence of bicuspid aortic valve anatomy among AVR patients (38% vs. 16%, p < 0.001). In addition, patients undergoing AVR had significantly larger LV end-diastolic and end-systolic volumes than their counterparts. After a median follow-up of 46 months (interquartile range: 17 to 78 months), both groups of patients showed a significant and sustained reduction in LV end-diastolic and end-systolic volumes, with significantly larger reduction in patients undergoing AVR. Ejection fraction decreased significantly postoperatively and improved later during follow-up similarly in both groups. The incidence of significant AR at long-term follow-up was comparable among groups (AVr: 8% vs. AVR: 7%). LV reverse remodeling occurs after AVR and AVr, reaching comparable LV volumes and function after a median of four years of follow-up.

068-I * CLINICAL AND HAEMODYNAMIC OUTCOMES IN 804 PATIENTS RECEIVING THE FREEDOM SOLO STENTLESS AORTIC VALVE: RESULTS FROM AN INTERNATIONAL PROSPECTIVE MULTICENTRE STUDY

OBJECTIVES: The Freedom SOLO™ valve (Sorin Group, Italy) is a stentless aortic bioprosthesis designed for simplified implantation. The present multicentre study is the largest prospective evaluation of this prosthesis. Herein, we report on outcomes at 3-year follow-up. METHODS: From March 2009 to February 2013, a total of 804 consecutive patients (mean age 74.9 ± 6.3 years; 45.1% females) underwent aortic valve replacement with the Freedom SOLO™ valve at 33 centres. Concomitant procedures (70.2% coronary artery bypass grafting) were performed in 376 patients. The cumulative follow-up included 1100 patient-years (mean 16.5 ± 10.8 months; range: 0–40.5 months). RESULTS: Sixty-four patients died (14 early, 50 late); 12 deaths (1 early, 11 late) were valve-related. Operative mortality (30 days) was 1.7%. At 3 years, overall survival was 82.6% [95% confidence interval (CI) 75.5–87.8%] and freedom from valve-related death was 95.5% (95% CI 89.2–98.2%). Linearized late event rates were 0.82%/patient-years for non-structural valve dysfunction, 0.55%/patient-years for structural valve deterioration, 1.55%/patient-years for endocarditis, 3.64%/patient-years for thromboembolism and 3.18%/patient-years for bleeding. In total, there were 22 reinterventions [19 valve explants, 2 refixations, 1 transcatheter aortic valve intervention (TAVI)] for endocarditis (11), non-structural dysfunction (9) and structural valve deterioration (2). Freedom from reintervention was 95.2% (95% CI 91.2–97.4%) at 3 years. There were no instances of valve thrombosis or haemolysis. At 1, 2 and 3 years, 97.0, 95.5 and 91.4% of patients were in NYHA class I or II. Between discharge and 3 years after surgery, mean transvalvular gradients exhibited a non-significant increase (6.5 ± 4.3 vs 8.7 ± 6.5 mmHg), whereas effective orifice area index remained stable (0.9 ± 0.2 vs 0.8 ± 0.3 cm 2 /m 2 ). At 3 years, no patient presented with more than mild aortic regurgitation. Left ventricular mass index decreased significantly between discharge and 1 year after surgery (139.4 ± 40.9 vs 122.4 ± 35.3 g/m 2 , P< 0.001) and remained unchanged thereafter. Left ventricular size and function did not change over time. CONCLUSIONS: The Freedom SOLO™ valve is a unique stentless pericardial bioprosthesis whose design favours haemodynamic performance and thus facilitates left ventricular reverse remodelling. In terms of survival, morbidity and functional status, it is associated with beneficial outcomes up to 3 years after surgery. Ongoing follow-up will assess the valve at the long-term course.

Efficacy of Stentless Aortic Bioprosthesis Implantation for Aortic Stenosis with Small Aortic Annulus.

In patients with small aortic annulus, sufficient size of stented aortic bioprosthesis cannot be implanted without additional procedures. In such cases, we use stentless aortic bioprosthesis to obtain sufficient effective orifice area. In this study, we investigated long-term impact of stentless aortic bioprosthesis on clinical outcomes, compared with stented aortic bioprosthesis. We retrospectively investigated 140 patients who underwent aortic valve replacement (AVR) with porcine bioprosthesis for severe aortic stenosis between 1999 and 2010. Patients who had moderate or more aortic regurgitation and who underwent concomitant mitral procedures were excluded. A total of 69 patients (49%) were implanted stentless bioprosthesis (Freestyle group; Medtronic Inc, Minneapolis, Minnesota, United States) and 71 patients (51%) were implanted stented bioprosthesis (Mosaic group; Medtronic Inc). Follow-up was complete in 97.9% patients. Median follow-up period was 4.2 years. Patients in Freestyle group had smaller body surface area, smaller aortic annulus diameter, smaller aortic valve area, larger mean pressure gradient, higher peak velocity across aortic valve, larger left ventricular mass index (LVMI), and lower left ventricular ejection fraction (LVEF). Mean size of implanted prosthesis was larger in Freestyle group. In-hospital mortality was 1.4% in Freestyle group and 2.8% in Mosaic group (p = 0.980). Five-year survival rate was not different between two groups (5-year survival rate was 87.5 ± 4.7% in Freestyle group and 84.1 ± 7.5% in Mosaic group; log rank, p = 0.619). Late New York Heart Association functional class was lower in Freestyle group. Late LVMI and LVEF became similar between two groups. Stentless aortic bioprosthesis is superior in left ventricular remodeling after AVR for aortic stenosis and is especially effective for small aortic annulus.

Use of balloon expandable transcatheter valves for valve-in-valve implantation in patients with degenerative stentless aortic bioprostheses: Technical considerations and results

Transcatheter valve-in-valve is an accepted treatment in high-risk patients with degenerative stented bioprostheses in the aortic position. Experience in treating stentless valves is, however, limited. Our aim was to determine the feasibility and single-center outcome of balloon expandable SAPIEN valve placement in degenerated stentless aortic valve bioprostheses. From February 2010 to January 2014, 10 patients with failing stentless bioprostheses underwent transcatheter aortic valve implantation using the Edwards SAPIEN transcatheter heart valve (SAPIEN, SAPIEN XT, and SAPIEN 3) at our institution. Seven patients had valve failure due to regurgitation and three to stenosis. The mean age was 73.3 ± 15.0 years. The mean logistic EuroSCORE was 31.8 ± 20.3, and the Society of Thoracic Surgeons score was 7.6 ± 5.4. Technical success was achieved in 9 of 10 patients. One patient required immediate placement of a second valve owing to low placement of the first. Two intraoperative complications developed that needed additional procedures. One patient underwent immediate repair of a right ventricular perforation from a pacing lead, the other, reexploration for epicardial bleeding. No deaths occurred. The median length of stay was 8.5 days (range, 3-44). The mean follow-up was 8.1 months (range, 1-21). No late reoperations or reinterventions were required. Transcatheter aortic valve implantation after previous stentless aortic valve replacement is technically demanding but a safe and feasible approach. The early results were excellent, with consistent improvement in hemodynamics. Prospective long-term follow-up in larger series is needed to evaluate this technique further.

Clinical experience with the Medtronic “3F” stentless aortic bioprosthesis - ten years follow-up

Clinical experience with the Medtronic “3F” stentless aortic bioprosthesis - ten years follow-up

Long-Term Clinical Outcomes 15 Years After Aortic Valve Replacement With the Freestyle Stentless Aortic Bioprosthesis

The Freestyle stentless aortic root bioprosthesis has excellent hemodynamics and durability through 10 years. The purpose of this report is to present clinical outcomes in a large multicenter cohort through 15 years. The multicenter evaluation of the Freestyle valve began in 1992 at 21 centers in North America and Europe. In 1997, a long-term study continued, including 725 patients from 8 of the original centers; clinical outcomes data after 10 years have continued to be collected at 6 of 8 centers. Patient age was 71.7±7.9 years. There were 402 (55.4%) men and 323 (44.6%) women. Total follow-up was 5,491.2 patient-years. There were 52 late reoperations, with explant of the bioprosthesis in 47 cases. Respective 10- and 15-year survival was 46.2%±2.3% and 25.9%±3.2%; freedom from valve-related death was 94.9%±1.5% and 92.7%±3.5%; freedom from reoperation was 92.3%±1.8% and 80.7%±5.0%; and freedom from explant owing to structural valve deterioration was 96.5%±1.3% and 83.3%±4.8%. Increased age was associated with higher risks of all-cause mortality and valve-related mortality and lower risks of reoperation and explant caused by structural valve deterioration. In this long-term, multicenter, observational study, the Freestyle stentless aortic root bioprosthesis offered good clinical outcomes in terms of survival, freedom from valve-related mortality, freedom from reoperation, and freedom from structural valve deterioration. The Freestyle valve is a viable option for use in patients undergoing bioprosthetic aortic valve replacement and for anticipated desire for long-term durability.