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Long-term Survival Following the Freestyle versus Homograft Aortic Root Replacement. Results from a Prospective Randomized Trial
Abstract
Objective:
The study objective was to investigate the long-term survival of patients undergoing xenograft versus homograft full root aortic valve replacement.
Methods:
A total of 166 patients requiring aortic valve surgery were randomized to undergo the Freestyle (Medtronic Inc, Minneapolis, Minn) bioprosthesis (N = 90) or a homograft (N = 76) full root aortic valve replacement between 1997 and 2005 in a single institution. Six patients randomly assigned to the homograft crossed over to the Freestyle bioprosthesis because of the unavailability of suitably sized homografts. All surgeons were required to adhere to the standard surgical technique for homograft root implantation previously described. Follow-up was 98.5% complete.
Results:
The mean age of the study population was 65 ± 8 years. Coronary artery bypass grafting was associated with root aortic valve replacement in 76 of 166 patients (46%, P = not significant between groups), and overall hospital mortality was 4.8% (8/166, P = not significant between groups). Median follow-up was 13.8 years (range, 0-21.8 years; 2033 patient-years). The Kaplan-Meier survival analysis showed that there was no significant difference in overall survival between the 2 arms at 5, 10, and 15 years. Twenty-year survival was 28.3% ± 5% for the Freestyle group versus 25.1% ± 5.7% for the homograft group (P = .90), which was comparable to the age- and sex-matched UK general population. The freedom from aortic valve reoperation at 20 years was comparable for the Freestyle group versus the homograft group (67.9% ± 8.8% vs 67.2% ± 10.3%, respectively; P = .74).
Conclusions:
This is the first study to investigate the long-term survival of xenograft versus homograft full root aortic valve replacement from a prospective randomized trial. The observed 20-year overall survival and freedom from aortic valve reoperation serve as a benchmark for future studies on interventions for aortic valve disease in the elderly.
... In contrast, the potential benefits of the stentless valve and root implantation have been widely acknowledged for their versatility and haemodynamics, enhanced by randomized data which also covered younger patients aged 40 and above [3,4]. There are certain clearly documented clinical indications, such as aortic root disease, bicuspid configuration and small aortic root [3,4]. ...
... In contrast, the potential benefits of the stentless valve and root implantation have been widely acknowledged for their versatility and haemodynamics, enhanced by randomized data which also covered younger patients aged 40 and above [3,4]. There are certain clearly documented clinical indications, such as aortic root disease, bicuspid configuration and small aortic root [3,4]. Moreover, the current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines recommended stentless autograft implantation in patients under 50 years of age. ...
... Moreover, the current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines recommended stentless autograft implantation in patients under 50 years of age. We believe that the latest long-term data and improvements in reoperation strategies support the continued interest in stentless valve implantations, including for younger populations [4,5]. ...
The study by Christ et al. [1] reports on results of propensity-matched long-term comparison of mechanical and stentless aortic valve implantation in patients under 60 years of age. Their analysis included 158 patients with stentless xenografts and 226 patients with mechanical valves. Sixty-six patient pairs were generated by propensity score matching. Actuarial freedom from redo at 20 years was 90.4 ± 4.1% in the mechanical group compared with 45.1 ± 8.2% in the stentless group. Despite a significantly higher reoperation rate after stentless valve implantation, actuarial long-term survival after 20 years was similar in both groups (53.3 ± 6.6% and 47.0 ± 6.4% for patients with mechanical and stentless bioprostheses, respectively). The authors should be congratulated on a successful and well-conducted prospective study with 100% availability.
Before drawing conclusions, however, there are several points to consider. Firstly, note that the stentless valves discussed in the study are no longer available, so to some extent, this study does not reflect on outcomes of modern stentless aortic valves and grafts. Previous generations of stentless valves have unfortunately exhibited suboptimal long-term durability, due to sinotubular junction dilatation or higher early gradients, which have been documented elsewhere [2].
... Stentless aortic root replacement enables difficult reconstructive surgery to be carried out at the outflow tract and the annular level. Recently, a prospective randomized controlled trial from the Royal Brompton and Harefield Hospitals group compared the long-term outcomes of homografts versus Medtronic Freestyle in 166 patients [47]. Overall survival at up to 20 years of follow-up showed no significant difference between the two groups, with similar findings in terms of freedom from aortic valve reoperation (67.9 ± 8.8% with Freestyle vs. 67.2 ...
... Overall survival at up to 20 years of follow-up showed no significant difference between the two groups, with similar findings in terms of freedom from aortic valve reoperation (67.9 ± 8.8% with Freestyle vs. 67.2 ± 10.3% with homograft; p = 0.74) [47]. Clemence et al. [48] obtained data from the Society for Thoracic Surgeons database for 265 patients with aortic valve IE who underwent AVR between 1998 and 2017. ...
Infective endocarditis (IE) is a severe cardiac complication with high mortality rates, especially when surgical intervention is delayed or absent. This review addresses the expanding role of surgery in managing IE, focusing on the variation in surgical treatment rates, the impact of patient demographics, and the effectiveness of different surgical approaches. Despite varying global data, a notable increase in surgical interventions for IE is evident, with over 50% of patients undergoing surgery in tertiary centres. This review synthesizes information from focused literature searches up to July 2023, covering preoperative to postoperative considerations and surgical strategies for IE. Key preoperative concerns include accurate diagnosis, appropriate antimicrobial treatment, and the timing of surgery, which is particularly crucial for patients with heart failure or at risk of embolism. Surgical approaches vary based on valve involvement, with mitral valve repair showing promising outcomes compared to replacement. Aortic valve surgery, traditionally favouring replacement, now includes repair as a viable option. Emerging techniques such as sutureless valves and aortic homo-grafts are explored, highlighting their potential advantages in specific IE cases. The review also delves into high-risk groups like intravenous drug users and the elderly, emphasizing the need for tailored surgical strategies. With an increasing number of patients presenting with prosthetic valve endocarditis and device-related IE, the review underscores the importance of comprehensive management strategies encompassing surgical and medical interventions. Overall, this review provides a comprehensive overview of current evidence in the surgical management of IE, highlighting the necessity of a multidisciplinary approach and ongoing research to optimize patient outcomes.
... Interestingly, the stentless aortic valve has recently demonstrated excellent results, comparable to the aortic homograft, when implanted as root replacement. [57] This valve may become a good option for patients over the age of 55 to 60 years. ...
... However, the use of transcatheter aortic valves might be complicated in stentless compared to conventional stented bioprostheses, almost depriving the patients of an important future treatment option [8]. Nevertheless, the use of stentless aortic valves is an indispensable tool in treating aortic root pathologies and small aortic annuli [3,9]. ...
Jasinski et al.’s Letter to the Editor nicely summarizes the main facts of the study by Christ et al. [1] as well as its shortcomings. In particular, the unavailability of the investigated first generation stentless valves today compromises the validity of the study results in the current situation. However, actually available stentless valves do not appear to be superior in terms of freedom from reoperation [2, 3], except compared to the Toronto SPV bioprosthesis [4].
When treating younger patients it is important to be aware that eventually >1 reoperation may be necessary after implantation of a biological valve. Even though reoperations for stentless valves have become safer [5], it is not desirable for patients to undergo cardiac surgery for 3 or 4 times. Mechanical valves are the best option to avoid reoperations, due to a low reoperation rate of 9.6% after 20 years [1]. Thromboembolic events (1.08%/patient-year) or bleeding (0.6%/patient-year) are low and anticoagulation treatment became easier with a lower INR target [1, 6, 7].
... [1][2][3] Stentless xenografts have superior hemodynamics compared with most stented bioprostheses and the Freestyle has shown equal durability and survival compared with other bioprostheses at up to 15 years follow-up. [3][4][5][6] However, the existing literature primarily regards selected populations from highly specialized centers. Hence, Freestyle performance in the most common setting of small-to-medium sized centers with unselected patients has not been determined. ...
Objectives
Our objective was to examine intermediate-term survival and reinterventions in unselected patients, stratified by indication, who received a Freestyle® bioprosthesis as a full aortic root replacement.
Methods
Data from medical records were retrospectively collected for patients who had aortic root replacement using Freestyle® bioprostheses between 1999 and 2018 at six North-Atlantic centers. Survival status was extracted from national registries and results stratified for indication for surgery.
Results
We included 1030 implantations in 1008 patients with elective indications for surgery: aneurysm (39.8%), small root (8.3%) and other (13.8%), and urgent/emergent indications: endocarditis (26.7%) and Stanford type A aortic dissection (11.4%). Across indications, 46.3% were non-elective cases and 34.0% were reoperations. Median age was 66.0 years (IQR 58.0-71.8) and median follow-up was 5.0 years (IQR 2.6-7.9). Thirty-day mortality varied from 2.9% to 27.4% depending on indication. Intermediate survival for 90-day survivors with elective indications were not different from the general population standardized by age and sex (p-values 0.95, 0.83 and 0.16 for aneurysms, small roots and other, respectively). In contrast, patients with endocarditis and type A dissection had excess mortality (p-values <0.001). Freedom from valve-reinterventions was 95.0% and 94.4% at five and eight years. In all, 52 patients (5.2%) underwent reinterventions, most due to endocarditis.
Conclusions
At intermediate term follow-up this retrospective study provides further support for the use of the Freestyle® bioprosthesis in the real-world setting of diverse, complex and often high-risk aortic root replacement and suggests that outcome is determined by patient- and disease-, rather than by prosthesis characteristics.
... The Medtronic Freestyle stentless porcine aortic root bioprosthesis (Medtronic, Inc, Minneapolis, Minn) has been approved by the US Food and Drug Administration since 1997, with studies demonstrating excellent hemodynamic properties as well as low rates of late structural valve deterioration. 1 Despite this, reports of structural abnormalities after Freestyle implantation, most commonly pseudoaneurysm formation, began to surface as early as 2005, 2 with the first report dedicated entirely to this topic being that of Ozaki and colleagues from Japan, 3 who described the unique failure mode of degeneration of the porcine aortic root sinus of Valsalva wall, leading to perforation and pseudoaneurysm formation. ...
... First, a recent randomized controlled trial comparing freestyle with homograft root replacements presents excellent 20-year results for both groups with life expectancies similar to the general population. 9 A 50% complication rate may not have allowed such outstanding results. Second, the rate of pseudoaneurysms in the series by Dagnegard and colleagues appears high and one would, at the illustrated rate and dimension, expect to detect it even with transthoracic echocardiography. ...
... Melina et al. recently described a randomized trial, comparing the overall survival rate of a different xenograft tissue such as, Freestyle graft (Medtronic) to the cryopreserved homograft, showing a similar 20-year overall survival rate. 55 Compared with BJV, the Freestyle graft undergoes a different commercial preparation, involving glutaraldehyde. This can further emphasize the importance of the fixation procedure on the durability or integrity of bioprostheses and presumably the susceptibility for IE. ...
Background: Pulmonary valve replacement is performed with excellent resultant hemodynamics in patients that have underlying congenital or acquired heart valve defects. Despite recent advancements in right ventricular outflow tract reconstruction, an increased risk of developing infective endocarditis remains, which has a more common occurrence for conduits of bovine jugular vein origin compared to cryopreserved homografts. The reason for this is unclear albeit it is hypothesized to be associated with an aberrant phenotypic state of cells that reendothelialize the graft tissue post implantation. The aim of this study was to develop an in vitro model that enables the analysis of endothelial cell attachment to cardiac graft tissues under flow. Experiment: Endothelial cell attachment was optimized on bovine pericardium patch using HUVECs. Different biological coatings, namely gelatin, fibronectin, plasma or a combination of fibronectin and plasma were tested. After cell adaptation, graft tissues were exposed to laminar flow in a parallel-plate flow chamber. Cell retention to the tissue was analyzed after nuclear staining with YO-PRO-1 and a membranous localization of VE-cadherin. Results: Combined coating with fibronectin and blood plasma together with a two-phased shear pattern resulted in a relevant cell monolayer on bovine pericardium patch and cryopreserved homograft. For bovine jugular vein tissue, no adherent cells under both static and shear conditions were initially observed. Conclusion: Presented in vitro system can serve as a competent model to study cell phenotypes on cardiac grafts under close-to-physiologic conditions. Lower affinity of bovine jugular vein conduit for cell attachment might be implicative of the risk of late-onset infective endocarditis.
... However, despite excellent hemodynamic performance, long-term durability showed no benefit as compared with stented aortic bioprostheses [76]. Full-root replacement using a Freestyle prothesis (Medtronic, Minneapolis, MN) was recently associated with acceptable long-term survival in the elderly and therefore may represent an alternative treatment option in this population [77]. Although, reoperations for failed stentless bioprotheses are more challenging procedures as compared to stented bioprostheses and may result in an increased risk of operative mortality [78]. ...
Introduction: Mixed aortic valve disease (MAVD) is defined by simultaneously occurrence of aortic stenosis (AS) and aortic regurgitation (AR). In our review, we focus on treatment options for nonelderly MAVD patients (age<55 years), who suffer from congenital aortic valve disease (unicuspid/bicuspid aortic valves).
Areas covered: A systematic literature search was performed on PubMed and Embase databases using the following terms: mixed aortic valve disease, aortic stenosis/regurgitation, bicuspid/unicuspid aortic valve, mechanical/bioprosthetic aortic valve replacement, TAVR, Ross procedure. After preselection of title and abstracts, two authors (M.S. and E.G.) assessed the methodological quality of the full-text articles prior to final inclusion in the manuscript.
Expert opinion: Currently, no ideal valvular substitutes are available in the treatment of nonelderly MAVD patients. Mechanical valves are associated with a reduced life expectancy due to a combination of prothesis-associated factors, mainly thrombotic and bleeding complications. Bioprostheses degenerate in the second decade and re-operations are inevitable, which also limit life expectancy. Long-term outcomes and durability of transcatheter aortic valve replacement are currently unknown. Finally, only Ross procedure is a therapeutic option with excellent long-term outcome comparable to the healthy population. However, the Ross procedure has some important drawbacks and should therefore be only performed in expert centers and in well-selected patients.
Objective:
Valve sparing root-replacement (VSRR) has been associated with good survival and low rates of valve-related complications (VRC). It is unclear whether these advantages are present irrespective of patient comorbidity or age. The aim of this study was to analyze survival and frequency of VRC in relation to patient comorbidity and age.
Methods:
Between 10/1995 and 12/2021, 1156 patients with bicuspid or tricuspid valves were treated by root remodeling. Mean age was 53.3±14 years, 973(84%) were male. Mean follow-up was 6.7±5.5 years(median 5.9 years); it was 95% complete(7746 patient-years). We analyzed the population according to comorbidity and age at surgery. A discriminating cut-off for the effect of age was determined using receiver operating characteristic curve(ROC) analysis.
Results:
Survival at 15 years was 74.7±2.5%. Deceased patients were older(65.3 ± 12 vs. 51.6±14.1 years; p<0.001) at the time of surgery and had more comorbidities(CAD; 28.4% vs. 9.8%;p<.001). The only significant adjusted predictors was age (p<.001). By ROC analysis (AUC 0.780), the optimal cut-off value for age was 61 years. Survival in patients <61 years was 87.1±2.8% at 15 years compared to 55.3±4.3% in patients > 61 years (p<.0001). Using competing risk analysis, VRC-free survival was 66.8% at 15 years. VRC-free survival was 76.7% for patients < 61 years and 52.4% for patients > 61 years at 15 years(P<.0001).
Conclusions:
VSRR is associated with a low incidence of VRC and excellent durability . Survival is decreased in the presence of comorbidities, mainly CAD and beyond a patient age of 61 years. Despite lower survival, freedom form VRC is good.
I read with great interest the letter to the editor written by Peterss et al. [1] in regard to our recently published study [2]. All the comments we have received so far share the same end point, indicating that an absolute ≥55-mm diameter for ascending aortic aneurysms deserves reappraisal as a surgical indication. Every day we experience the fact that a significant number of patients who suffer from type A aortic dissection display aortic diameters that are actually smaller than 55 mm. Therefore, if it was applied to managing ascending aortic aneurysms, the ‘one size fits all’ concept would be responsible for avoidable deaths.
In their letter to the editor, Peterss et al. [1] argued that the real prevalence of asymptomatic thoracic aorta aneurysms is still unknown and that several patients with dilated ascending aortas never experience aortic dissection or rupture. In our view, this comment requires further clarification. Indeed, several epidemiological studies have already addressed this issue. Mori et al. [3] investigated a population of 5662 individuals and reported the prevalence of thoracic aorta dilatation, which was defined as an ascending thoracic aorta diameter ≥4.0 cm, of overall 2.1%, meaning 3.2% for males and 0.9% for females. Patients with aneurysms were significantly older (70.2 ± 9.9 vs 58.3 ± 16.4 years, P < 0.001) and significantly more likely to be male (81.0% vs 54.2%, P < 0.001).
We read with great interest the article by Tozzi et al. [1] from Lausanne. The authors focused on the important topic of estimating the aortic diameter prior to the occurrence of an acute type A aortic dissection. By simply subtracting 7 mm (previously identified by the Yale group retrospectively [2]) from the post-dissection diameter in 102 non-syndromic patients, they determined that 99% of their patients would not have reached the threshold for prophylactic ascending replacement. Thus, the authors concluded that the indications for such prophylactic surgery should be changed to lower diameters, a conclusion that we generally support.
Two major issues, however, have to be considered concerning this kind of reasoning. (1) The prevalence of non-dissecting, non-syndromic aortic aneurysmal disease at any specific size and thus the denominator of the equation, are completely unknown! Aortic aneurysms represent a silent disease whose presence as well as progression is often an incidental finding. Furthermore, the ‘normal’ aortic diameter at any age and for any sex may be estimated fairly accurately using established formulas [3, 4]. (2) The numerator for calculating risk models and a reliable number-needed-to-treat, however, also remains unknown! Epidemiological studies emphasize a significant number of unrecorded dissection cases at autopsy [5].
Background
Aortic homografts have been used in young patients requiring aortic valve replacement(AVR). Currently, they are generally reserved for aortic valve endocarditis with or without root abscess, however, longitudinal data are lacking. Our aim was to assess the long-term safety and durability of homograft implantation.
Methods
All adult patients undergoing aortic homograft implantation at a single institution from 1992-2019 were included. Outcomes of interest included all-cause mortality and AV reoperation, studied over a median follow-up duration of 19 years.
Results
A total of 252 patients were included, with a mean age of 49 years. Infective endocarditis was the primary indication for surgery in 95(38%) patients. The endocarditis group had a higher prevalence of NYHA III-IV(56% vs. 26%), chronic kidney disease(CKD)(22% vs. 1%), prior cardiac surgery(40% vs. 10%), and emergency status(7% vs. 0%) compared to those without endocarditis(all p<.001). Operative mortality was higher among endocarditis patients(16% vs. 0.6%, p<0.001), which persisted following risk-adjustment. In patients who survived to discharge, however, there was no difference in long-term survival between endocarditis and non-endocarditis groups. Overall survival and freedom from re-operation were 88.3% and 80% at 15 years and 87.2% and 78.0% at 25 years, respectively. Indications for re-operation included structural valve deterioration(SVD)(83%), endocarditis(12%), and mitral valve disease(5%). Reoperative mortality occurred in 2(4.9%).
Conclusions
Aortic homografts are associated with good long-term survival and admissible freedom from re-operation. Operative mortality is high in patients with endocarditis, however, in those who survive to discharge, long-term survival and durability are like those without endocarditis.
Background:
The value of allografts for aortic root replacement is controversial, with recent concern about limited durability. Currently, we prefer allografts for invasive infective endocarditis. Purposes of this study were to assess allograft performance and durability in our cumulative experience with aortic allografts.
Methods:
From 1/1987-1/2017, 2,042 adults received 2,110 aortic allograft root replacements at our institution, 986 (47%) for infective endocarditis (669 [68%] for prosthetic valve endocarditis) and 1,124 (53%) for other indications. Mean recipient age was 54±15 years and mean allograft donor age 35±13 years. Follow-up was 85% complete and comprised 17,253 patient-years of data. Longitudinal allograft performance was extracted from 6,339 available echocardiographic studies. Durability was assessed by explant for allograft structural failure.
Results:
Allograft mean gradient at hospital discharge was 6 mmHg and 9, 13, and 15 mmHg at 5, 10, and 15 years post-implant. Severe aortic regurgitation was 0% at hospital discharge, but 14%, 25%, and 35% at 5, 10 and 15 years. 405 allografts were explanted for structural failure, actuarially 2%, 14%, 34%, and 51% at 5, 10, 15, and 20 years. Risk factors for structural failure were younger recipient age, larger body surface area, hypertension, and thoracic aorta disease; donor factors were older age and larger allograft size. Implant for infective endocarditis was not associated with accelerated structural failure.
Conclusions:
This study affirms allografts' long-term acceptable hemodynamic performance and durability. Concern about structural failure should not limit allograft use. Recipient hypertension, allograft size, and donor age are modifiable risk factors.
Objective:
To support decision-making in aortic valve replacement (AVR) in elderly patients, we provide a comprehensive overview of outcome after AVR with bioprostheses.
Methods:
A systematic review was conducted of studies reporting clinical outcome after AVR with bioprostheses in elderly patients (mean age ≥70 years; minimum age ≥65 years) published between January 1, 2000, to September 1, 2016. Reported event rates and time-to-event data were pooled and entered into a microsimulation model to calculate life expectancy and lifetime event risks.
Results:
Forty-two studies reporting on 34 patient cohorts were included, encompassing a total of 12,842 patients with 55,437 patient-years of follow-up (pooled mean follow-up 5.0 ± 3.3 years). Pooled mean age was 76.5 ± 5.5 years. Pooled early mortality risk was 5.42% (95% confidence interval [CI], 4.49-6.55), thromboembolism rate was 1.83%/year (95% CI, 1.28-3.61), and bleeding rate was 0.75%/year (95% CI, 0.50-1.11). Structural valve deterioration (SVD) was based on pooled time to SVD data (Gompertz; shape: 0.124, rate: 0.003). For a 75-year-old patient, this translated to an estimated life expectancy of 9.8 years (general population: 10.2 years) and lifetime risks of bleeding of 7%, thromboembolism of 17%, and reintervention of 9%.
Conclusions:
The low risks of SVD and reintervention support the use of bioprostheses in elderly patients in need of AVR. The estimated life expectancy after AVR was comparable with the general population. The results of this study inform patients and clinicians about the expected outcomes after bioprosthetic AVR and thereby support treatment decision-making. Furthermore, our results can be used as a benchmark for long-term outcomes after transcatheter aortic valve implantation in patients who were eligible for surgery and other (future) alternative treatments (eg, tissue-engineered heart valves).
Background:
Projections of future mortality and life expectancy are needed to plan for health and social services and pensions. Our aim was to forecast national age-specific mortality and life expectancy using an approach that takes into account the uncertainty related to the choice of forecasting model.
Methods:
We developed an ensemble of 21 forecasting models, all of which probabilistically contributed towards the final projections. We applied this approach to project age-specific mortality to 2030 in 35 industrialised countries with high-quality vital statistics data. We used age-specific death rates to calculate life expectancy at birth and at age 65 years, and probability of dying before age 70 years, with life table methods.
Findings:
Life expectancy is projected to increase in all 35 countries with a probability of at least 65% for women and 85% for men. There is a 90% probability that life expectancy at birth among South Korean women in 2030 will be higher than 86·7 years, the same as the highest worldwide life expectancy in 2012, and a 57% probability that it will be higher than 90 years. Projected female life expectancy in South Korea is followed by those in France, Spain, and Japan. There is a greater than 95% probability that life expectancy at birth among men in South Korea, Australia, and Switzerland will surpass 80 years in 2030, and a greater than 27% probability that it will surpass 85 years. Of the countries studied, the USA, Japan, Sweden, Greece, Macedonia, and Serbia have some of the lowest projected life expectancy gains for both men and women. The female life expectancy advantage over men is likely to shrink by 2030 in every country except Mexico, where female life expectancy is predicted to increase more than male life expectancy, and in Chile, France, and Greece where the two sexes will see similar gains. More than half of the projected gains in life expectancy at birth in women will be due to enhanced longevity above age 65 years.
Interpretation:
There is more than a 50% probability that by 2030, national female life expectancy will break the 90 year barrier, a level that was deemed unattainable by some at the turn of the 21st century. Our projections show continued increases in longevity, and the need for careful planning for health and social services and pensions.
Funding:
UK Medical Research Council and US Environmental Protection Agency.
Many observational studies have reported outcomes after surgical aortic valve replacement (AVR), but there are no recent systematic reviews and meta-analyses including all available bioprostheses and allografts. The objective of this study is to provide a comprehensive and up-to-date overview of the outcomes after AVR with bioprostheses and allografts reported in the last 15 years. We conducted a systematic literature review (PROSPERO register: CRD42015017041) of studies published between 2000-15. Inclusion criteria were observational studies or randomized controlled trials reporting on outcomes of AVR with bioprostheses (stented or stentless) or allografts, with or without coronary artery bypass grafting (CABG) or valve repair procedure, with study population sizen≥ 30 and mean follow-up length ≥5 years. Fifty-four bioprosthesis studies and 14 allograft studies were included, encompassing 55 712 and 3872 patients and 349 840 and 32 419 patient-years, respectively. We pooled early mortality risk and linearized occurrence rates of valve-related events, reintervention and late mortality in a random-effects model. Sensitivity, meta-regression and subgroup analyses were performed to investigate the influence of outliers on the pooled estimates and to explore sources of heterogeneity. Funnel plots were used to investigate publication bias. Pooled early mortality risks for bioprostheses and allografts were 4.99% (95% confidence interval [CI], 4.44-5.62) and 5.03% (95% CI, 3.61-7.01), respectively. The late mortality rate was 5.70%/patient-year (95% CI, 4.99-5.62) for bioprostheses and 1.68%/patient-year (95% CI, 1.23-2.28) for allografts. Pooled reintervention rates for bioprostheses and allografts were 0.75%/patient-year (95% CI, 0.61-0.91) and 1.87%/patient-year (95% CI, 1.52-2.31), respectively. There was substantial heterogeneity in most outcomes. Meta-regression analyses identified covariates that could explain the heterogeneity: implantation period, valve type, patient age, gender, pre-intervention New York Heart Association class III/IV, concomitant CABG, study design and follow-up length. There is possible publication bias in all outcomes. This comprehensive systematic review and meta-analysis provides an overview of the outcomes after AVR with bioprostheses and allografts reported during the last 15 years. The results of this study can support patients and doctors in the prosthetic valve choice and can be used in microsimulation models to predict patient outcomes and estimate the cost-effectiveness of AVR with bioprostheses or allografts compared with current and future heart valve prostheses.
Based on a voluntary registry of the German Society for Thoracic and Cardiovascular
Surgery (GSTCVS), data of all heart surgery procedures performed in 78 German cardiac
surgical units during the year 2014 are presented. In 2014, a total of 100,398 cardiac
surgical procedures (implantable cardioverter-defibrillator and pacemaker procedures
excluded) were submitted to the registry. More than 14.2% of the patients were older
than 80 years, describing an increase of 0.4% compared with the previous year. The
unadjusted in-hospital mortality for 40,006 isolated coronary artery bypass grafting
procedures (84.7% on-pump, 15.3% off-pump) was 2.6%. In 31,359 isolated valve procedures
(including 9,194 catheter-based procedures), an in-hospital mortality of 4.4% was
observed. This annual updated registry of the GSTCVS is published since 1989. It is an
important tool for quality assurance and voluntary public reporting by illustrating current
standards and actual developments for nearly all cardiac surgical procedures in Germany.
Although porcine aortic valves or pericardial tissue mounted on a stent have made implantation techniques easier, these valves sacrifice orifice area and increase stress at the attachment of the stent, which causes primary tissue failure. Optimizing hemodynamics to prevent patient-prosthetic mismatch and improve durability, stentless bioprostheses use was revived in the early 1990s. The purpose of this review is to provide a current overview of stentless valves in the aortic position. Retrospective and prospective randomized controlled studies showed similar operative mortality and morbidity in stented and stentless aortic valve replacement (AVR), though stentless AVR required longer cross-clamp and cardiopulmonary bypass time. Several cohort studies showed improved survival after stentless AVR, probably due to better hemodynamic performance and earlier left ventricular (LV) mass regression compared with stented AVR. However, there was a bias of operation age and nonrandomization. A randomized trial supported an improved 8-year survival of patients with the Freestyle or Toronto valves compared with Carpentier-Edwards porcine valves. On the contrary, another randomized study did not show improved clinical outcomes up to 12 years. Freedom from reoperation at 12 years in Toronto stentless porcine valves ranged from 69% to 75%, which is much lower than for Carpentier-Edwards Perimount valves. Cusp tear with consequent aortic regurgitation was the most common cause of structural valve deterioration. Cryolife O'Brien valves also have shorter durability compared with stent valves. Actuarial freedom from reoperation was 44% at 10 years. Early prosthetic valve failure was also reported in patients who underwent root replacement with Shelhigh stentless composite grafts. There was no level I or IIa evidence of more effective orifice area, mean pressure gradient, LV mass regression, surgical risk, durability, and late outcomes in stentless bioprostheses. There is no general recommendation to prefer stentless bioprostheses in all patients. For new-generation pericardial stentless valves, follow-up over 15 years is necessary to compare the excellent results of stented valves such as the Carpentier-Edwards Perimount and Hancock II valves.
The full homograft root replacement has been regarded as the 'gold standard' for aortic valve replacement (AVR). Xenograft full root AVR may offer similar theoretical advantages, but no prospective randomized trials to compare the two valve substitutes have been reported to date.
A total of 147 patients (mean age 66.2 years; range: 40-82 years) was randomized to undergo either Medtronic Freestyle (group F; n = 80) or homograft (group H; n = 67) root AVR. Coronary artery bypass grafting was associated with root AVR in 55 patients (37.4%). Follow up included routine clinical and echocardiographic assessments.
Overall, there were seven early deaths (4.8%). The early mortality rate for isolated root AVR was 2.1% in group F (1/47) and 2.2% in group H (1/45) (p = NS). There were four late deaths in group F, and two in group H. Actuarial survival was 83+/-5% and 84+/-4% (p = NS) at five years, in groups F and H, respectively. No patient required reoperation on the aortic valve. Overall, there were eight thromboembolic events and six anticoagulant-related bleeding events; these were equally divided between the two groups. After a median follow up of 45 months, most patients in both groups were in NYHA class I, and the mean trans-aortic gradient was 6+/-1 mmHg in group F and 5+/-2 mmHg in group H (p = NS). Mild aortic regurgitation was recorded in 1/26 patients (4%) of group F, and in 1/16 (6%) of group H.
The Medtronic Freestyle porcine xenograft appears to be a good alternative to homografts for full aortic root replacement, at least in the mid term.
In the same way as genetic engineering, nanotechnology and more recently artificial biology,¹ tissue engineering has captured the imagination of clinicians, scientists, investors and most importantly those who stand to be affected most, patients. This advance has heightened expectations, but the prospect of tissue engineering is coupled with legitimate concerns, fear of the unknown and ethical issues for consideration, particularly in relation to the expected use of stem cells and growth factors.
Valvular heart diseases are not usually regarded as a major public-health problem. Our aim was to assess their prevalence and effect on overall survival in the general population.
We pooled population-based studies to obtain data for 11 911 randomly selected adults from the general population who had been assessed prospectively with echocardiography. We also analysed data from a community study of 16 501 adults who had been assessed by clinically indicated echocardiography.
In the general population group, moderate or severe valve disease was identified in 615 adults. There was no difference in the frequency of such diseases between men and women (p=0.90). Prevalence increased with age, from 0.7% (95% CI 0.5-1.0) in 18-44 year olds to 13.3% (11.7-15.0) in the 75 years and older group (p<0.0001). The national prevalence of valve disease, corrected for age and sex distribution from the US 2000 population, is 2.5% (2.2-2.7). In the community group, valve disease was diagnosed in 1505 (1.8% adjusted) adults and frequency increased considerably with age, from 0.3% (0.2-0.3) of the 18-44 year olds to 11.7% (11.0-12.5) of those aged 75 years and older, but was diagnosed less often in women than in men (odds ratio 0.90, 0.81-1.01; p=0.07). The adjusted mortality risk ratio associated with valve disease was 1.36 (1.15-1.62; p=0.0005) in the population and 1.75 (1.61-1.90; p<0.0001) in the community.
Moderate or severe valvular diseases are notably common in this population and increase with age. In the community, women are less often diagnosed than are men, which could indicate an important imbalance in view of the associated lower survival. Valve diseases thus represent an important public-health problem.
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.
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.
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).
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.
Objective
Over the past decades, the indication for allograft implantation in aortic position has evolved. The purpose of this study is to report long-term survival, allograft durability, and potential risk factors.
Methods
Between 1987 and 2010, 353 patients underwent aortic valve replacements via allograft (92 subcoronary, 261 root replacement; 98% aortic allografts). Patient characteristics, survival, valve durability, and valve-related events were analyzed. Patients also were followed with standardized echocardiography. A joint modeling approach was used to detect the effect of (echocardiographic) variables on mortality and reoperation hazard.
Results
Mean age was 45 years (range, 1 month to 84 years); 71% were males. The etiology was endocarditis in 32% (active 22%), congenital 31%, degenerative 9%, aneurysm/dissection 12%, rheumatic 6%, and prosthetic valve failure 10%. Hospital mortality was 5.9% (n = 21). During follow-up (mean 12 years, range, 0-24; 99% complete), 113 patients died. Twenty-year cumulative survival was 41% (95% confidence interval, 32-50). Valve-related reoperations occurred in 117 patients: 100 structural valve deterioration, 9 nonstructural valve deterioration, and 8 endocarditis. Competing-risk analysis predicted that at 20 years 31% died, and 30% were alive without reoperation. Younger patient age was associated with increased reoperation. During follow-up left ventricular dilatation and severe aortic regurgitation were associated with mortality (P = .006 and .005, respectively), and grade 3 or greater aortic regurgitation during follow-up was associated with risk of reoperation (P = .001).
Conclusions
After almost 3 decades of experience with allografts in aortic position, the indication for use has become selective, mainly because of progressive structural valve deterioration over time. In case of complex aortic root pathology and active endocarditis allografts may still be useful.
Transcatheter aortic valve implantation (TAVI) has become the standard of care for inoperable patients, and the preferred treatment option for high-risk patients with severe aortic stenosis. Given that this therapy was intended for elderly patients with limited life expectancy, long-term durability has not been in the focus. Now that TAVI is increasingly being used in patients with intermediate-risk and lower-risk profiles, device durability has gained importance. The available mid-term results for TAVI are promising; however, little is known about the fate of TAVI devices beyond 5 years. The experience with long-term durability of surgical valves shows that ≥10-year follow-up is required to ensure reliable durability data. In this Review, we discuss the existing studies of TAVI durability, highlight differences between surgical and transcatheter treatment of aortic stenosis that might influence durability, and present a clinical solution for failed prostheses. Furthermore, we suggest how device durability might influence the future selection of patients for TAVI.
Objective:
To evaluate long-term results of aortic root procedures combined with ascending aorta replacement for aneurysms, using 4 surgical strategies.
Methods:
From January 1995 to January 2011, 957 patients underwent 1 of 4 aortic root procedures: valve preservation (remodeling or modified reimplantation, n = 261); composite biologic graft (n = 297); composite mechanical graft (n = 156); or allograft root (n = 243).
Results:
Seven deaths occurred (0.73%), none after valve-preserving procedures, and 13 strokes (1.4%). Composite grafts exhibited higher gradients than allografts or valve preservation, but the latter 2 exhibited more aortic regurgitation (2.7% biologic and 0% mechanical composite grafts vs 24% valve-preserving and 19% allografts at 10 years). Within 2 to 5 years, valve preservation exhibited the least left ventricular hypertrophy, allograft replacement the greatest; however, valve preservation had the highest early risk of reoperation, allograft replacement the lowest. Patients receiving allografts had the highest risk of late reoperation (P < .05), and those receiving composite mechanical grafts and valve preservation had the lowest. Composite bioprosthesis patients had the highest risk of late death (57% at 15 years vs 14%-26% for the remaining procedures, P < .0001), because they were substantially older and had more comorbidities (P < .0001).
Conclusions:
These 4 aortic root procedures, combined with ascending aorta replacement, provide excellent survival and good durability. Valve-preserving and allograft procedures have the lowest gradients and best ventricular remodeling, but they have more late regurgitation, and likely, less risk of valve-related complications, such as bleeding, hemorrhage, and endocarditis. Despite the early risk of reoperation, we recommend valve-preserving procedures for young patients when possible. Composite bioprostheses are preferable for the elderly.
Background — Despite the many advantages of an aortic allograft valve (AAV) over a prosthetic aortic valve, its durability is suboptimal. The aims of the present study were to document characteristic features of AAV dysfunction and to investigate factors influencing the development of such dysfunction.
Methods and Results — A group of 570 patients (mean age, 48±16 years) with a cryopreserved AAV underwent a follow-up echocardiographic study (mean time after surgery, 6.8 years; range, 1.0 to 22.9 years). Significant AAV regurgitation was present in 14.7% of patients, and AAV stenosis was present in 3.2%. The root replacement subgroup had the smallest number of patients with significant AAV regurgitation (5.0%) compared with the subcoronary (23.0%) or the inclusion cylinder technique subgroup (14.7%). After 10 to 15 years after AAV replacement, grade ≥2 AAV dysfunction was present in 40% of patients in the subcoronary subgroup, but no significant dysfunction was observed in patients in the root replacement subgroup ( P <0.001). Smaller host aortic annulus size in both subcoronary (coefficient, −0.145; P =0.013) and root replacement subgroups (coefficient, −0.249; P =0.011) was associated with more frequent AAV dysfunction (grade ≥2). In addition, significant AAV dysfunction was more frequent when patients were younger (coefficient, −0.020; P =0.015) in the subcoronary subgroup and the donor was older (coefficient, 0.054; P =0.019) in the root replacement subgroup.
Conclusions — The present study indicates that the root replacement technique is associated with less frequent AAV degeneration. Our findings should help in establishing more strict selection criteria for surgical replacement procedure type and patient/donor factors for AAV replacement and, therefore, could lead to improve AAV longevity.
Received July 27, 2001; revision received October 15, 2001; accepted October 21, 2001.
Increased life expectancy and younger patients' desire to avoid lifelong anticoagulation requires a better understanding of bioprosthetic valve failure. This study evaluates risk factors associated with explantation for structural valve deterioration (SVD) in a long-term series of Carpentier-Edwards PERIMOUNT aortic valves (AV).
From June 1982 to January 2011, 12,569 patients underwent AV replacement with Edwards Lifesciences Carpentier-Edwards PERIMOUNT stented bovine pericardial prostheses, models 2700PM (n = 310) or 2700 (n = 12,259). Mean age was 71 ± 11 years (range, 18 to 98 years). 93% had native AV disease, 48% underwent concomitant coronary artery bypass grafting, and 26% had additional valve surgery. There were 81,706 patient-years of systematic follow-up data available for analysis. Demographics, intraoperative variables, and 27,386 echocardiographic records were used to identify risks for explant for SVD and assess longitudinal changes in transprosthesis gradients using time-varying covariable analyses.
Three hundred fifty-four explants were performed, with 41% related to endocarditis and 44% to SVD. Actuarial estimates of explant for SVD at 10 and 20 years were 1.9% and 15% overall, respectively, and in patients younger than 60 years, 5.6% and 46%, respectively. Younger age (p < 0.0001), lipid-lowering drugs (p = 0.002), prosthesis-patient mismatch (p = 0.001), and higher postoperative peak and mean AV gradients were associated with explant for SVD (p < 0.0001). The effect of gradient on SVD was greatest in patients younger than 60 years.
Durability of the Carpentier-Edwards PERIMOUNT aortic valve is excellent even in younger patients. Explant for SVD is related to gradient at implantation, especially in younger patients. Strategies to reduce early postoperative AV gradients, such as root enlargement or more efficient prostheses, should be considered.
Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
Background
A growing literature describes aneurysmal deterioration after implantation of the stentless porcine aortic Medtronic Freestyle bioprosthesis (MFB; Medtronic Inc, Minneapolis, MN), with some suggesting inadequate tissue fixation with immune response as a cause. However, disjointed reports make the significance of these findings difficult to interpret. We address this concern by aggregating available data.
Methods
We reviewed institutional data, the Food and Drug Administration’s Manufacturer and User Facility Device Experience registry, and the medical literature for mention of aneurysm or pseudoaneurysm after MFB. Case details were aggregated, and the rate of aneurysmal deterioration was estimated. Immunohistopathologic examination of institutional explanted specimens was performed to elucidate a cause.
Results
We found 42 cases of aneurysmal deterioration with adequate detail for analysis; all occurred with full root replacement and valve sizes ranging from 23 to 29 mm. The rate of aneurysmal deterioration considering all data sources was 1.1% (9 of 851; 95% confidence interval, 0.5% to 2.0%) vs 4.7% (4 of 86; 95% confidence interval, 1.3% to 11.5%) at our institution, where yearly surveillance imaging is performed. Rate of aneurysmal deterioration appeared constant until 5 years after the operation; however, events are reported out to 10 years. Consistent with previous reports, histopathology demonstrated an immune cell infiltrate in areas of MFB wall breakdown.
Conclusions
Aneurysmal deterioration is an increasingly described complication of MFB implantation as a full root, with an incidence as high as 4.7%. Given the observed immune reaction and lack of occurrence in smaller (19-mm and 21-mm) valve sizes, inadequate pressure fixation of larger valves is a potential etiology. Patients with MFB require annual surveillance imaging, and consideration of this complication should factor into preoperative decision making because treatment mandates redo root replacement, which may not be feasible in high-risk patients.
Background
The Medtronic Freestyle bioprosthesis (FSB) provides an alternative to other prostheses for both aortic valve and aortic root surgery. This paper is a systematic review of the post-operative outcomes in patients with aortic valve and/or aortic root disease following FSB implantation.
Methods
Electronic databases were searched; for primary analysis, prospective randomised studies comparing the FSB with an alternative aortic prosthesis were included. Additionally, case series that included data for at least 100 individual operated patients were used for secondary analysis.
Results
Among three identified randomised studies, 199 FSB cases were compared with homografts, and stented and an alternative stentless bioprosthesis. The FSB showed comparable hospital mortality (4.5% vs 5.3%) and eight-year actuarial survival (80 ± 5.0% versus 77 ± 6.0%) with the homograft (respectively) and comparable reduction in left ventricular mass index relative to other prosthesis types. Over 6000 individual patients were included in the selected 15 case series. Weighted mean operative mortality, neurological event rate and five-year actuarial survival was 5.2%, 5.5% and 77.8%, respectively.
Conclusion
The FSB performed comparably against alternative prostheses regarding in-hospital mortality, long-term survival and reduction in left ventricular mass index. Included case series demonstrated robust post-operative outcomes in both the short and long term.
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.
Stentless aortic bioprostheses were designed to provide enhanced hemodynamic performance and potentially greater longevity. The present report describes the outcomes of patients with the Freestyle stentless bioprosthesis followed for ≤18 years.
Between 1993 and 2011, 430 patients underwent primary aortic valve replacement with a Freestyle bioprosthesis in the subcoronary position. Mean age was 68.2±8.2 years. All of the clinical and echocardiographic data were collected prospectively. Mean overall follow-up was 9.1±4.4 years and was complete in all of the patients. In-hospital mortality was 3.5% (n=15). Overall, 10- and 15-year survival were 60.7% and 35.0%, respectively. Fifty-one patients required reoperation during follow-up, including 27 for structural valve deterioration (SVD). Overall, freedom from reoperation was 91.0% and 75.0% at 10 and 15 years, whereas freedom from reoperation for SVD was 95.9% and 82.3%, respectively. At 10 and 15 years, freedom from reoperation for SVD was 94.0% and 62.6% for patients <60 years of age and 96.3% and 88.4% for patients ≥60 years of age (P=0.002). The median time to explant for SVD was 10.7 years. SVD presented mostly as acute, severe aortic insufficiency attributed to leaflet tear (77.8%). The independent risk factors for reoperation for SVD were age <60 years (P=0.001) and dyslipidemia (P=0.02).
Aortic valve replacement with the Freestyle bioprosthesis in a subcoronary position provides good long-term clinical and echocardiographic outcomes for patients >60 years of age. Severe aortic insufficiency with leaflet tear is the major mode of SVD leading to reoperation in these patients.
Although the aortic outflow and root (AoR) constitute a short channel connecting the left ventricle to the aorta, its different components have been shown to be highly specialized structures, interacting with each other as well as with surrounding structures, thus providing a “tale of dynamism and crosstalk.” Thorough knowledge of the AoR and morphological and structural changes, that occur during pathological processes, can have important implications in evolving and executing surgical procedures designed to preserve and restore the “dynamism and crosstalk.” The crown-shaped annulus, fibrous trigones, aortic cusps components, aortic sinuses, and the sinotubular junction share a dynamic coordinated behavior, which can be partially or completely restored in various repair or replacement procedures of the AoR. The interaction and the specific operations are presented with evidence supporting the notion that the dynamic behavior of the root does influence the pattern of instantaneous movements of the aortic cusps after different types of operations. Further studies are required to evaluate the influence of adopting these ideas on the long-term results of operative procedures.
Aortic valve replacement is accepted as a standard treatment for aortic stenosis and regurgitation. To help plan the national requirement for conventional and catheter-based procedures, we have analyzed the Society for Cardiothoracic Surgery in Great Britain and Ireland audit database to look at changes in practice over time.
All patients undergoing conventional aortic valve replacement with or without coronary artery surgery from April 2004 to March 2009 were included. The main outcome measures were changes in the number, characteristics, operative details, and in-hospital mortality. We have looked particularly at trends and outcomes in elderly and high-risk patients (EuroSCORE of 10 or more) who may now be considered for percutaneous aortic valve insertion.
A total of 41,227 patients underwent aortic valve surgery over 5 years with an in-hospital mortality of 4.1%. The annual number increased from 7396 in 2004-2005 to 9333 in 2008-2009, with significant increases (P < .0005) in mean age (68.8-70.2 years), the proportion of patients with aortic stenosis (62.4%-65.1%), octogenarians (13.6%-18.4%), high-risk patients (24.6%-27.7%), and those receiving biological valves (65.4%-77.8%). The incidence of permanent cerebrovascular accident was 1.2% and 1.0% in patients having only an aortic valve replacement. The dialysis rate was 4.5% and the reoperation rate for bleeding was 6.6%. Overall mortality decreased from 4.4% in 2004-2005 to 3.7% in 2008-2009. Survival to a mean follow-up of 2.5 years was 89%.
We have seen a large increase in annual volume of aortic valve replacements, with more patients undergoing surgery for aortic stenosis and an increase in surgery in the elderly and high-risk patients.
The study aims to report results of re-operations after aortic allograft root implantation.
All consecutive patients in our prospective allograft database, who underwent aortic allograft root implantation, were selected for analysis, and additional information for patients who subsequently underwent re-operation was obtained from hospital records.
From 1989 to 2009, 262 aortic allograft root implantations were performed. Thirty-day mortality was 5.7%. During follow-up, 69 patients died. The actuarial survival was 77.0% (95% confidence interval (CI) 71-83%) after 10 years, and 65.1% (95% CI 57-74%) after 14 years. A total of 52 patients required re-operation. The actuarial freedom from allograft re-operation was 82.9% (Standard Error (SE) 2.9%) after 10 years and 55.7% (SE 5.7%) after 14 years. The actuarial median time to re-operation was 14.8 years. The indications for re-operation were structural valve dysfunction in 46 patients, endocarditis in two patients and non-structural valve dysfunction in four patients. The re-operations included 23 aortic valve replacements (mechanical prostheses 20 and bioprostheses 3), 27 aortic root replacements (mechanical conduits 21, aortic allografts five, and biological conduit one), one trans-apical valve implantation and one primary closure of a false aneurysm. The additional procedures were mitral valve repair (N = 5), mitral valve replacement (N = 1), ascending aortic replacement (N = 5), and coronary artery bypass grafting (CABG) (N = 4; in two patients unforeseen). Thirty-day mortality after re-operation occurred in two patients (3.9%). Five patients died during follow-up. The survival after re-operation was 87.1% (SE 5.5%) after 1 year and 79.3% (SE 7.4%) after 9 years.
Re-operations after aortic allograft root implantation will be required in a substantial and growing number of patients. These re-operations, although technically demanding, can be performed with satisfying results.
The aims of this study were to compare long-term results after homograft versus Freestyle (Medtronic Inc., Minneapolis, Minnesota) aortic root replacement.
The ideal substitute for aortic root replacement remains undetermined.
Between 1997 and 2005, 166 patients (age 65 +/- 8 years) undergoing total aortic root replacement were randomized to receive a homograft (n = 76) or a Freestyle bioprosthesis (n = 90). Six patients randomly assigned to homograft crossed over to Freestyle because of unavailability of suitably sized homografts. Median follow-up was 7.6 years (maximum 11 years; 1,035 patient-years). "Evolving" aortic valve dysfunction was defined as aortic regurgitation >/=2/4 and/or peak gradient >20 mm Hg.
Patient characteristics were comparable between groups. Concomitant procedures were performed in 44% and 47% of Freestyle and homograft patients, respectively (p = 0.5). Overall hospital mortality was 4.8% (1% for isolated root replacement). Eight-year survival was 80 +/- 5% in the Freestyle group versus 77 +/- 6% in the homograft group (p = 0.9). Freedom from need for reoperation at 8 years was significantly higher after Freestyle root replacement (100 +/- 0% vs. 90 +/- 5% after homograft replacement; p = 0.02). All reoperations were secondary to structural valve deterioration (n = 6). At last echocardiographic follow-up, actuarial freedom from evolving aortic valve dysfunction was 86 +/- 5% for Freestyle bioprostheses versus 37 +/- 7% for homografts (p < 0.001). Clinically, freedom from New York Heart Association functional class III to IV and freedom from valve-related complications were similar between groups (p = 0.7 and p = 0.9, respectively).
In this patient group, late survival is similar after homograft versus Freestyle root replacement. However, Freestyle aortic root replacement is associated with significantly less progressive aortic valve dysfunction and a lower need for reoperations.
Two hundred seventy-five unprocessed, viable homograft ("homovital") aortic valves were used for aortic valve replacement in patients aged 1.5 to 79 years (mean 45.8 +/- 19 years) with maximum follow-up of a 14-year period (mean 4.8 years). Ninety-two percent (252 patients) had New York Heart Association class III or IV functional status before operation and 25 underwent emergency operation. Valves were harvested under sterile conditions and kept in nutrient medium 199. Freehand (subcoronary) technique was used in 147 patients and freestanding root replacement was used in 128. Cumulative survival rates for the whole group were 92% +/- 2% at 5 years and 85% +/- 3% at 10 years, as compared with 96% +/- 2% and 94% +/- 4%, respectively, for the 98 patients who underwent isolated root replacement. Multivariate analysis determined that root replacement with associated procedures and operation for prosthetic endocarditis were risk factors for death, whereas previous xenograft valve, operation for endocarditis, and operation for aortic regurgitation were risk factors for reoperation. Actuarial rates for freedom from degenerative valve failure diagnosed at operation, by postmortem examination, or by routine echocardiography were 94% +/- 2% at 5 years and 89% +/- 3% at 10 years. Recipient age younger than 30 years and previous xenograft valve were risk factors for late degeneration. We conclude that homovital valves demonstrate good durability, particularly in patients older than 30 years, who had a 10-year freedom from degeneration rate of 97%.
Allografts offer many advantages over prosthetic valves, but allograft durability varies considerably.
From 1969 through 1993, 618 patients aged 15 to 84 years underwent their first aortic valve replacement with an aortic allograft. Concomitant surgery included aortic root tailoring (n = 58), replacement or tailoring of the ascending aorta (n = 56), and coronary artery bypass grafting (n = 87). Allograft implantation was done by means of a "freehand" subcoronary technique (n = 551) or total root replacement (n = 67). The allografts were antibiotic sterilized (n = 479), cryopreserved (n = 12), or viable (unprocessed, harvested from brain-dead multiorgan donors or heart transplant recipients, n = 127). Maximum follow-up was 27.1 years.
Thirty-day mortality was 5.0%, and crude survival was 67% and 35% at 10 and 20 years. Ten- and 20-year rates of freedom from complications were as follows: endocarditis, 93% and 89%; primary tissue failure, 62% and 18%; and redo aortic valve replacement, 81% and 35%. Multivariable Cox analyses identified several valve- and procedure-related determinants: rising allograft donor age and antibiotic-sterilized allograft for mortality; donor more than 10 years older than patient for endocarditis; rising donor age minus patient age, rising implantation time (from harvest to aortic valve replacement), and donor age more than 65 years for tissue failure; and rising donor age minus patient age, young patient age, rising implantation time, and subcoronary implantation preceded by aortic root tailoring for redo aortic valve replacement. Estimated 10- and 20-year rates of freedom from tissue failure for a 70-year-old patient with a viable valve from a 30-year-old donor and no other risk factors were 91% and 64%; the figures were 71% and 20% if the donor age was 65 years. The rates of freedom from tissue failure for a 30-year-old patient with a 30-year-old donor were 82% and 39%; the figures were 49% and 3% with a 65-year-old donor. Beneficial influences of a viable valve were largely covered by short harvest time (no delay for allografts from brain dead organ donors or heart transplant recipients) and short implantation time.
Primary allograft aortic valve replacement can give acceptable results for up to 25 years. The late results can be improved by the use of a viable allograft, by matching patient and donor age, and by more liberal use of free root replacement with re-implantation of the coronary arteries rather than tailoring the root to accommodate a subcoronary implantation.
Bioprostheses are widely used as an aortic valve substitute, but knowledge about prognosis is still incomplete. The purpose of this study was to provide insight into the age-related life expectancy and actual risks of reoperation and valve-related events of patients after aortic valve replacement with a porcine bioprosthesis.
We conducted a meta-analysis of 9 selected reports on stented porcine bioprostheses, including 5837 patients with a total follow-up of 31 874 patient-years. The annual rates of valve thrombosis, thromboembolism, hemorrhage, and nonstructural dysfunction were 0.03%, 0.87%, 0.38%, and 0.38%, respectively. The annual rate of endocarditis was estimated at 0.68% for >6 months of implantation and was 5 times as high during the first 6 months. Structural valve deterioration was described with a Weibull model that incorporated lower risks for older patients. These estimates were used to parameterize, calibrate, and validate a mathematical microsimulation model. The model was used to predict life expectancy and actual risks of reoperation and valve-related events after implantation for patients of different ages. For a 65-year-old male, these figures were 11.3 years, 28%, and 47%, respectively.
The combination of meta-analysis with microsimulation enabled a detailed insight into the prognosis after aortic valve replacement with a bioprosthesis for patients of different ages. This information will be useful for patient counseling and clinical decision making. It also could serve as a baseline for the evaluation of newer valve types.
Bioprosthesis durability decreases with time and younger age. However, the time-scale and determinants of durability of the aortic Carpentier-Edwards stented bovine pericardial prosthesis are incompletely characterized.
Between September 1981 and January 1984, 267 patients underwent implantation of the pericardial aortic prosthesis at four centers. Mean age at implant was 65 +/- 12 years (range 21 to 86 years). Follow-up averaged 12 +/- 4.5 years. The primary end point was explant for structural valve dysfunction (SVD), which was analyzed multivariably in the context of death as a competing risk.
Freedom from explant due to SVD was 99%, 94%, and 77% at 5, 10, and 15 years. Risk of SVD increased exponentially with time and younger age (p = 0.0001) at implantation; an increased risk of small valve size was not reliably demonstrated (p = 0.1). Considering the competing risk of death, patients aged 65 years or older had a less than 10% chance of explant for SVD by 15 years.
Durability of this stented pericardial aortic bioprosthesis is excellent and justifies its use in patients aged 65 or older.
Despite the many advantages of an aortic allograft valve (AAV) over a prosthetic aortic valve, its durability is suboptimal. The aims of the present study were to document characteristic features of AAV dysfunction and to investigate factors influencing the development of such dysfunction.
A group of 570 patients (mean age, 48+/-16 years) with a cryopreserved AAV underwent a follow-up echocardiographic study (mean time after surgery, 6.8 years; range, 1.0 to 22.9 years). Significant AAV regurgitation was present in 14.7% of patients, and AAV stenosis was present in 3.2%. The root replacement subgroup had the smallest number of patients with significant AAV regurgitation (5.0%) compared with the subcoronary (23.0%) or the inclusion cylinder technique subgroup (14.7%). After 10 to 15 years after AAV replacement, grade > or =2 AAV dysfunction was present in 40% of patients in the subcoronary subgroup, but no significant dysfunction was observed in patients in the root replacement subgroup (P<0.001). Smaller host aortic annulus size in both subcoronary (coefficient, -0.145; P=0.013) and root replacement subgroups (coefficient, -0.249; P=0.011) was associated with more frequent AAV dysfunction (grade > or =2). In addition, significant AAV dysfunction was more frequent when patients were younger (coefficient, -0.020; P=0.015) in the subcoronary subgroup and the donor was older (coefficient, 0.054; P=0.019) in the root replacement subgroup.
The present study indicates that the root replacement technique is associated with less frequent AAV degeneration. Our findings should help in establishing more strict selection criteria for surgical replacement procedure type and patient/donor factors for AAV replacement and, therefore, could lead to improve AAV longevity.
Completeness of follow-up is important, especially in clinical trials, since unequal follow-up in the treatment groups can bias the analysis of results. In survival studies, information on participants who do not complete the study is often omitted because their data can be included up to the time at which they were lost to follow-up. We propose a simple measure of completeness that is the ratio of the total observed person-time and the potential person-time of follow-up in a study. Our measure is easy to calculate, can be illustrated pictorially, and can be used to identify subgroups with especially poor follow-up.
This study aimed at calculating and comparing the long-term outcomes of patients after aortic valve replacement with the Carpentier-Edwards bovine pericardial and porcine supraannular bioprostheses using microsimulation.
We conducted a meta-analysis of eight studies on the Carpentier-Edwards pericardial valves (2,685 patients, 12,250 patient-years) and five studies on the supraannular valves (3,796 patients, 20,127 patient-years) to estimate the occurrence rates of valve-related events. Eighteen-year follow-up data sets were used to construct age-dependent Weibull curves that described their structural valvular deterioration. The estimates were entered into a microsimulation model, which was used to calculate the outcomes of patients after aortic valve replacement.
The annual hazard rates for thrombo-embolism after aortic valve replacement were 1.35% and 1.76% for the pericardial and supraannular valves, respectively. For a 65-year-old male, median time to structural valvular deterioration was 20.1 and 22.2 years while the lifetime risk of reoperation due to structural valvular deterioration was 18.3% and 14.0%, respectively. The life expectancy of the patient was 10.8 and 10.9 years and event-free life expectancy 9.0 and 8.8 years, respectively.
The microsimulation methodology provides insight into the prognosis of a patient after aortic valve replacement with any given valve type. Both the Carpentier-Edwards pericardial and supraannular valve types perform satisfactorily, especially in elderly patients, and show no appreciable difference in long-term outcomes when implanted in the aortic position.
Our objective was to examine the clinical outcomes of aortic valve replacement with the Toronto SPV bioprosthesis at 12 years.
The Toronto SPV was used for aortic valve replacement in 357 patients from July 1991 to December 2004. There were 244 men and 113 women with a mean age of 65 +/- 10 years. Aortic stenosis was present in 79% of patients, coronary artery disease in 38%, and left ventricular ejection fraction less than 0.40 in 12%. Patients had an annual assessment of valve function using echocardiography. The mean duration of follow-up was 7.7 +/- 3.2 years.
There were 2 operative and 79 late deaths, of which 13 were valve related and 25 heart related. Survival at 12 years was 64% +/- 4% and similar to that of the general population matched for age and sex. Forty-nine patients had echocardiographic evidence of bioprosthetic dysfunction. The freedom from structural valve degeneration at 12 years was 69% +/- 4% for all patients, 52% +/- 8% for patients less than 65 years of age, and 85% +/- 4% for patients 65 years of age or older (P = .002). Fifty patients had redo aortic valve replacement: 45 for structural valve degeneration and 5 for endocarditis. The freedom from redo aortic valve replacement at 12 years was 69% +/- 4%. Cusp tear with consequent aortic insufficiency was the most common cause of structural valve degeneration. At the latest follow-up contact, 226 (63%) patients were alive with the Toronto SPV valve in place, and 69% were in functional class I, 24% in class II, and 7% in class III.
The Toronto SPV bioprosthesis has provided optimal patient survival and symptomatic improvement but suboptimal valve durability, particularly in patients less than 65 years of age. We now use of this valve mostly in older patients who have a small aortic annulus.
Future life expectancy in 35 industrialised countries: projections with a Bayesian model ensemble.
- Kostis V.
- Bennet J.E.
- Mathers C.D.
- Li G.
- Foreman K.
- Ezzati M.
Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants.
- D R Johnston
- E G Soltesz
- N Vakil
- J Rajeswaran
- E E Roselli
- J F Sabik
- Iii