Pericardial Aortic Bioprosthesis Research Articles

Early Outcomes of Pulmonary Valve Replacement With the Edwards Inspiris Resilia Pericardial Bioprosthesis.

Controversy regarding the optimal pulmonary valve substitute remains, with no approved surgical valve for pulmonary valve replacement (PVR). Furthermore, unfavorable anatomy often precludes transcatheter PVR in patients with congenital heart disease. We therefore sought to evaluate the feasibility of the Edwards Inspiris pericardial aortic bioprosthesis in the pulmonary position in pediatric and adult patients requiring PVR. Data from consecutive patients who underwent PVR from February 2019 to February 2021 at our institution were retrospectively reviewed. Postoperative adverse events included paravalvular or transvalvular leak, endocarditis, explant, thromboembolism, valve thrombosis, valve-related bleeding, hemolysis, and structural valve degeneration. Progression of valve gradients was assessed from discharge to 30 days and one year. Of 24 patients with median age of 26 years (interquartile range [IQR]: 17-33; range: 4-60 years), 22 (91.7%) patients had previously undergone tetralogy of Fallot repair and 2 (8.3%) patients had undergone double-outlet right ventricle repair in the neonatal period or infancy. All patients had at least mild right ventricular (RV) dilatation (median RV end-diastolic volume index 161.4, IQR: 152.3-183.5 mL/m2) and at least moderate pulmonary insufficiency (95.8%) or stenosis (8.3%). Median cardiopulmonary bypass and cross-clamp times were 71 (IQR: 63-101) min and 66 (IQR: 60-114) min, respectively. At a median postoperative follow-up of 2.5 years (IQR: 1.4-2.6; range: 1.0-3.0 years), there were no mortalities, valve-related reoperations, or adverse events. Postoperative valve gradients and the severity of pulmonary regurgitation did not change significantly over time. At short-term follow-up, the bioprosthesis in this study demonstrated excellent safety and effectiveness for PVR. Further studies with longer follow-up are warranted.

Late clinical and echocardiographic results with the Magna Ease© pericardial aortic bioprosthesis.

The population of candidates to surgical aortic valve replacement (SAVR) is evolving. The Perimount Magna Ease© bioprosthesis has been introduced relatively recently in the practice. We aimed at evaluating its long-term results. This article describes a single-centre cohort of 1016 consecutive SAVRs with the Magna Ease© valve (2008-2014), consisting of an all-comers population. We performed a prospective collection of in-hospital data, systematic clinical and echocardiographic follow-up. Valve-related events were as follows: structural valve deterioration (SVD; according to modified definition criteria), nonstructural valve dysfunction, patient-prosthesis mismatch (PPM). Age at SAVR was 73.4 ± 9.5 years; calcified aortic stenosis was the indication to surgery in 59.6%. A total of 974 patients entered the follow-up; 564 were alive at the last follow-up (median duration: 9.8 years) (up to 13.4 years). New York Heart Association class was I or II in 92.1%. Overall survival at 10 years was 56.8 ± 1.8%. Freedom from SVD at 10 was 96.5 ± 0.8% (Kaplan-Meier) and 97.4 ± 0.6% (competing risks) (28 SVD events after 6.9 ± 3.3 years). There were 15 reinterventions for SVD (redo-SAVR and Transcatheter Aortic Valve Implantation (TAVI)); 10-year freedom from reintervention was 97.8 ± 0.6%. Moderate and severe PPM occurred in 26.8% and 5.4%, respectively, without association with late mortality (P = 0.12 for moderate and P = 0.70 for severe PPM). Freedom from valve-related mortality was 97.8 ± 0.5% at 10 years. In this follow-up of the Magna Ease bioprosthesis for SAVR, data indicate good late outcomes (30-day outcomes are excluded). Continued follow-up is required to further support its use in patients with life expectancy >10-12 years.

Budget impact analysis of a bovine pericardial aortic bioprosthesis versus mechanical aortic valve replacement in adult patients with aortic stenosis in Romania

AimsAn analysis of the budget impact of using a bovine pericardial aortic bioprosthesis (BPAB) or a mechanical valve (MV) in aortic stenosis (AS) patients in Romania.Materials and methodsA decision-tree with a partitioned survival model was used to predict the financial outcomes of using either a BPAB (the Carpentier-Edwards Perimount Magna Ease Valve) or MV in aortic valve replacement (AVR) procedure over a 5-year period. The budget impact of various resource consumption including disabling strokes, reoperations, minor thromboembolic events, major bleeding, endocarditis, anticoagulation treatment and monitoring, and echocardiogram assessments were compared for both types of valves. One-way sensitivity analyses (OWSA) were conducted on the input costs and probabilities.ResultsThe use of BPAB compared to MV approaches budget neutrality due to incremental savings year-on-year. The initial surgical procedure and reoperation costs for BPAB are offset by savings in acenocoumarol use, disabling strokes, major bleeding, minor thromboembolic events, and anticoagulation complications. The cost of the initial procedure per patient is 460 euros higher for a BPAB due to the higher valve acquisition cost, although this is partially offset by a shorter hospital stay. The OWSA shows that the total procedure costs, including the hospital stay, are the primary cost drivers in the model.LimitationsResults are limited by cost data aggregation in the DRG system, exclusion of costs for consumables and capital equipment use, possible underestimation of outpatient complication costs, age-related variations of event rates, and valve durability.ConclusionsAdopting BPAB as a treatment option for AS patients in Romania can lead to cost savings and long-term economic benefits. By mitigating procedure costs and increasing anticoagulation treatment costs, BPAB offers a budget-neutral option that can help healthcare providers, policymakers, and patients alike manage the growing burden of AS in Romania.

Durability of a bovine pericardial aortic bioprosthesis based on Valve Academic Research Consortium-3 echocardiographic criteria

ObjectivesThe Carpentier-Edwards Perimount Magna Ease (Edwards Lifesciences) pericardial bioprosthesis has demonstrated satisfying hemodynamics at midterm follow-up, but its durability remains unclear. We report our 10-year experience with this third-generation valve implanted in the aortic position, with particular attention to structural valve deterioration. MethodsFrom 2007 to 2016 at our center, 338 patients underwent aortic valve replacement using the Perimount Magna Ease pericardial bioprosthesis. Patients were prospectively followed (mean 6.6 ± 2.6 years) with clinical evaluation and yearly echocardiography. Follow-up was 98% complete (7 patients lost) for a total of 2238 valve-years. Bioprosthesis structural valve deterioration was determined by strict echocardiographic assessment based on the Valve Academic Research Consortium 3 criteria. ResultsOverall operative mortality was 1.2%. Actuarial survival including early deaths averaged 80.9% ± 2.2% and 66.7% ± 4.4% after 5 and 10 years of follow-up, respectively. Actuarial freedom from explantation due to structural valve deterioration at 5 and 10 years was 99.6% ± 0.4% and 88.8% ± 5.0%, respectively, and actuarial freedom of structural valve deterioration at 5 and 10 years was 98.5% ± 0.7% and 44.0% ± 6.4%, respectively. More precisely, actuarial freedom of structural valve deterioration stage 3 was 99.6% ± 0.4% at 5 years and 88.3% ± 5.0% at 10 years, whereas freedom of structural valve deterioration stage 2/3 was 98.5% ± 0.7% and 60.9% ± 7.0%, respectively. ConclusionsWith a low rate of explantation due to structural valve deterioration events at 10 years, and particularly a low rate of moderate or severe structural valve deterioration based on echocardiographic Valve Academic Research Consortium 3 criteria, the Carpentier-Edwards Perimount Magna Ease pericardial bioprosthesis remains a reliable choice for a tissue valve in the aortic position. Video Abstract [Display omitted]

Intermediate-term outcomes of aortic valve replacement using a bioprosthesis with a novel tissue

ObjectivesThe COMMENCE trial was conducted to evaluate the safety and effectiveness of an aortic bioprosthesis with novel RESILIA tissue (Edwards Lifesciences, Irvine, Calif). Reports of early noncalcific valve failure resulting from thrombosis or leaflet tears in other valves warrant careful evaluation of early valve performance. MethodsPatients underwent clinically indicated surgical aortic valve replacement with the Edwards Pericardial Aortic Bioprosthesis, Model 11000A (Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), single-arm, Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee; echocardiograms were analyzed by an independent core laboratory. ResultsBetween January 2013 and March 2016, 689 patients received the study valve. Mean age was 67.0 ± 11.6 years. Mean Society of Thoracic Surgeons predicted risk of mortality was 2.0% ± 1.8%. Follow-up duration was 3.7 ± 1.2 years, with a total of 2533 patient years of follow-up and a median follow-up of 4 years. Early all-cause mortality was 1.2%, thromboembolism 2.3%, all bleeding 1.0%, and major paravalvular leak 0.1%. One- and 4-year actuarial freedom from all-cause mortality was 97.7% (95% confidence interval, 96.5%-98.8%) and 91.9% (95% confidence interval, 89.7%-94.1%), respectively. At 4 years, New York Heart Association functional class improved compared with baseline in 63.0%, effective orifice area was 1.5 ± 0.5 cm2, and mean gradient was 11.0 ± 5.6 mm Hg. Freedom from moderate or greater transvalvular insufficiency was 99.7%. There were no events of structural valve deterioration. ConclusionsSafety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue at 4 years are favorable. This novel tissue does not appear to result in unexpected early thrombosis events or noncalcific structural valve deterioration.

One-year outcomes associated with a novel stented bovine pericardial aortic bioprosthesis

ObjectivesThe study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovine pericardial aortic valve. MethodsThis trial enrolled patients with symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. We assessed death, valve-related adverse events, functional recovery, and hemodynamic performance at discharge, 3 to 6 months, and 1 year, as required by the US Food and Drug Administration for regulatory approval. The primary analysis compared late linearized rates of valve-related adverse events after implantation with Food and Drug Administration–specified objective performance criteria to determine whether the adverse event rates associated with the valve are within acceptable limits. Adverse events included thromboembolism, thrombosis, all and major hemorrhage, all and major paravalvular leak, and endocarditis. ResultsThe primary analysis included 864 patients who received an implant and 904.1 valve-years of follow-up. A total of 577 patients completed the 1-year evaluation. The primary end point was met for death, thromboembolism, thrombosis, all and major paravalvular leak, and endocarditis, but not for all and major hemorrhage. At 1 year, freedom from all death and from valve-related death was 96.4% and 99.7%, respectively. From baseline to 1 year, New York Heart Association class changed as follows: I, 10.8% to 73.7%; II, 48.9% to 22.6%; III, 38.0% to 3.5%; and IV, 2.3% to 0.2%. Effective orifice area increased from 0.9 ± 0.5 to 1.5 ± 0.4 (P < .0001), and mean aortic gradient decreased from 42.7 ± 16.5 to 12.5 ± 4.3 (P < .0001). ConclusionsThis analysis of a new stented bovine pericardial aortic valve demonstrated low overall mortality and valve-related adverse events, and hemodynamic performance comparable to that of other surgical aortic valves.

Structural valve deterioration of a Carpentier-Edwards aortic pericardial bioprosthesis in a 68-year-old male patient

Structural valve deterioration of a Carpentier-Edwards aortic pericardial bioprosthesis in a 68-year-old male patient

Long-term results of the Mitroflow aortic pericardial bioprosthesis in over 800 patients: limited durability and mechanisms of dysfunction.

The Mitroflow aortic pericardial bioprosthesis was widely employed in the past. However, some authors have recently reported early structural valve deterioration (SVD) of the Mitroflow LA/LXA model. Thus, we reviewed our experience with the Mitroflow bioprosthesis and studied the risk factors for SVD and mortality. Records of patients who underwent aortic valve replacement with a Mitroflow bioprosthesis between November 2005 and January 2015 were retrospectively evaluated with Kaplan-Meier, Cox-regression and multistate analysis. Only patients with a complete clinical follow-up were included in the study. Average follow-up was 45 months and ended on 1 April 2016. Between November 2005 and January 2015, among the 916 patients undergoing aortic valve replacement with the Mitroflow prosthesis at our Institution, the 832 (90.8%) patients with follow-up information were included into the study. Fifty-two (6.2%) patients developed SVD (stenosis, n = 38; regurgitation, n = 7; mixed, n = 7). Freedom from SVD was 95.4% and 67.9%, at 5 and 9 years, respectively, without differences after stratification according to the prosthesis model ( P = 0.87) and prosthesis size ( P = 0.70). At the multivariable analysis, increasing age was identified as a protective factor against SVD (hazard ratio = 0.94, P < 0.001). Twenty (38.4%) patients with SVD underwent redo aortic valve replacement. At 5 and 9 years, survival was 64.5% and 43.1%, repectively. According to the multistate analysis, the fraction of patients living with degenerated valves at 9 years was 10.0%; 7.1% died following degeneration. The LA/LXA Mitroflow model showed limited long-term durability. Degenerated prostheses showed more stenosis than regurgitation. Patient age played an important role in the development of SVD.

Clinical outcome and hemodynamic behavior of the Labcor Dokimos Plus aortic valve.

BackgroundThe Labcor Dokimos Plus (LDP) is a stented externally mounted pericardial aortic bioprosthesis, which was recently introduced in Europe. Aims of the study are evaluation of operative and postoperative results as well as hemodynamic performance.MethodsOne hundred consecutive patients with a mean age of 65.9 ± 10.7 years (range 35–87) and a mean EuroSCORE II of 3.1 ± 3.9 (range 0.67–24.5) underwent aortic valve replacement with the LDP. Mean valve-size was 25.2 ± 1.7 mm. Concomitant procedures were performed in 34% of the cases. Postoperative clinical data were analyzed and hemodynamic performance of the prostheses was evaluated by transthoracic echocardiography. Clinical follow-up was 100%, echocardiographic follow-up was 93% complete.ResultsIntraoperatively no peculiarities occurred. Mean cross clamp times for isolated and complex procedures were 74.5 ± 20.0 min and 103.7 ± 37.1 min, respectively. Patients were extubated after a mean of 9.4 ± 15.8 h. There were no perioperative strokes. Bleeding events occurred in 4 patients. 30-day-mortality was 2%. One case of early endocarditis occurred. Echocardiography showed maximum and mean pressure gradients of 18.1 ± 6.4 and 9.6 ± 3.7 mmHg, respectively. Correspondingly to valve sizes 21, 23, 25 and 27 mm, mean pressure gradients were 17.3, 9.5, 8.5 and 10.2 mmHg, effective orifice areas were 1.92, 1.79, 2.0, 2.16 cm2 and indexed effective orifice areas were 1.08, 0.95, 0.99 and 1.01 cm2/m2, respectively. No relevant regurgitations occurred.ConclusionsThe LDP showed operatively no peculiarities and a satisfactory clinical outcome with low perioperative morbidity and mortality. The hemodynamic performance of the implanted valve sizes was satisfactory.

Early Postoperative Results of the Dokimos Plus Stented Pericardial Aortic Bioprosthesis for Isolated Aortic Valve Replacement and Hemodynamic Comparison with Sorin Solo, Labcor TLBP-A, and ATS 3f

Early Postoperative Results of the Dokimos Plus Stented Pericardial Aortic Bioprosthesis for Isolated Aortic Valve Replacement and Hemodynamic Comparison with Sorin Solo, Labcor TLBP-A, and ATS 3f

Early Postoperative Results of the Dokimos Plus Stented Pericardial Aortic Bioprosthesis

Early Postoperative Results of the Dokimos Plus Stented Pericardial Aortic Bioprosthesis

Haemodynamic performance of a new pericardial aortic bioprosthesis during exercise and recovery: comparison with pulmonary autograft, stentless aortic bioprosthesis and healthy control groups

Since blood flow impairment by aortic valve prosthesis is characteristically dynamic, this dynamic component is best and thoroughly appreciated by exercise Doppler echocardiography. We sought to determine the haemodynamics of a new pericardial aortic bioprosthesis [Trifecta™-aortic valve bioprosthesis (T-AVB), St Jude Medical, MN, USA] at rest and during exercise and a 10-min recovery period in comparison with alternative aortic valve prostheses, e.g. Ross operation (RO), stentless aortic valve [Medtronic freestyle-aortic valve bioprosthesis (MF-AVB)] and a healthy control group (CO). Haemodynamics at rest and during supine exercise stress testing and a 10-min recovery period were evaluated in 32 patients (mean age: 70.8 ± 6.7 years) with T-AVB (mean follow-up: 5 ± 2 months), 49 with RO (mean age: 43.5 ± 13.7 years), 39 with an MF-AVB (mean age: 64.6 ± 9.4 years) and 26 healthy patients (mean age: 39 ± 9 years). Measurements included mean outflow tract gradient (δp mean, mmHg), effective orifice area index (EOAI, cm(2)/m(2)) and valvular resistance (vR, dyn s cm(-5)). Mean body surface area for T-AVB was 1.93 ± 0.24 m(2) (median 1.97 m(2)). Mean δp mean at rest was 7.2 ± 3.4 mmHg, mean EOAI 0.86 ± 0.23 cm(2)/m(2) and mean vR 50.7 ± 23.2 dyn s cm(-5). Supine stress testing did increase the mean EOAI to 0.98 ± 0.27 cm(2)/m(2), the mean vR to 62.6 ± 25.3 dyn s cm(-5) and the mean δp mean to 10.21 ± 4.7 mmHg, respectively (P < 0.05 for all comparisons). During the post-exercise recovery period, δp mean, EOAI and vR showed a prompt normalization within 5 min of cessation of exercise. At all the three measurement points, T-AVB and MF-AVB revealed low gradients, satisfactory EOAI and low vR. Compared with the RO and a healthy control group, both groups showed significantly inferior performance throughout the exercise and post-exercise study protocol (P < 0.05). In comparison with T-AVB, patients with an MF-AVB only showed significant inferior performance throughout series with respect to a higher vR, indicating a smaller increase in the EOAI during exercise. During the 10-min post-exercise period, T-AVB recovered significantly earlier than MF-AVB. When comparing two different types of aortic valve bioprostheses with a gold standard group (RO) and a healthy population, both aortic valve bioprostheses perform inferior but reveal promising haemodynamics during exercise. During post-exercise haemodynamic recovery, only the T-AVB revealed a nearly physiological recovery pattern compared with the RO and a healthy control group.

A missing leaflet: a rare cause of structural deterioration of a bovine pericardial aortic bioprosthesis—report of a case

We experienced a rare cause of aortic bioprosthesis deterioration in which one of the leaflets disappeared 8.7 years after primary aortic valve replacement (AVR) in a male octogenarian. Successful redo AVR with a 23-mm Magna EASE (Carpentier-Edwards, Irvine, CA) was performed. No embolic complications occurred. We were unable to identify the cause of this devastating complication. When heart failure symptoms develop in patients with bioprostheses, clinicians should therefore consider a diagnosis of acute progression of structural valve deterioration and follow the patient carefully with echocardiography.

Mitroflow pericardial aortic bioprosthesis in patients younger than 60 years

Mitroflow pericardial aortic bioprosthesis in patients younger than 60 years

Hemodynamic Performance of Mitroflow Aortic Pericardial Bioprosthesis – Optimizing Management for the Small Aortic Annulus

Documentation of the hemodynamics of the Mitroflow aortic pericardial bioprosthesis has been incomplete. The aim of the study was to provide reference effective orifice areas for the implant calculation of effective orifice area indexes to avoid prosthesis-patient mismatch. Echocardiograms were evaluated in 55 patients (39 females, 16 males), mean age 77.0 +/- 6.9 years (range 51-90 years). The mean time of the studies was 11.0 months. The prosthesis sizes and numbers evaluated were 19 mm (n = 13), 21 mm (n = 19), 23 mm (n = 13) and 25 mm (n = 10). Peak aortic velocities averaged from 2.2 to 2.7 m/sec, mean gradients from 10.6 to 15.1 mmHg, peak gradients from 20.7 to 29.7 mmHg, and effective orifice area (EOA) from 1.4 to 1.8 cm (2). When accounting for the subaortic velocity, mean gradients averaged from 7.5 to 10.0 mmHg, and peak gradients averaged 15.1 to 23.5 mmHg. The effective orifice area indexes ranged from 0.8 to 1.0 cm (2)/m (2). The mean postoperative left ventricular mass index was 101.6 gm/m (2). The IN VIVO effective orifice areas by valve size of the Mitroflow aortic pericardial bioprosthesis provide the opportunity of avoiding obstructive characteristics for all valve sizes, including optimizing the management of the small aortic annulus.

Mitroflow aortic pericardial bioprosthesis — clinical performance☆☆☆

Advancing life expectancy with the increased prevalence of aortic valve degenerative disease brings the need for an aortic bioprosthesis with excellent haemodynamic performance and comparable durability. The Mitroflow bioprosthesis has been on the worldwide market, except in the United States, since 1982, while the current model (1991) has only recently gained regulatory approval in the latter country. This study was primarily performed to determine the durability of the current Mitroflow bioprosthesis. The contemporary Mitroflow bioprosthesis was implanted in 381 patients in three centres. The mean age was 76.4 years (range 53-91 years) and the mean follow-up period was 5.4+/-3.4 years, a total of 2048.7 years of evaluation. Prosthesis-patient mismatch (PPM) was classified by reference effective orifice area index categories: normal > or = 0.85 cm(2) m(-2) (53.9%), mild 0.84-0.76 cm(2) m(-2) (33.9%), moderate < or = 0.75-0.66 cm(2) m(-2) (11.7%) and severe < or = 0.65 cm(2) m(-2) (0.5%). The survival, at 10 years, was 39.9+/-7.9% for 50-69 years, 27.0+/-3.7% for 70-79 years and 16.6+/-4.4% for > or = 80 years (p=0.011). There was a trend (p=0.063) influencing survival for moderate-to-severe PPM. Of the independent predictors influencing survival--moderate-to-severe projected effective orifice area index (pEOAI) (Hazard Ratio (HR) 1.6, p=0.0142) and left ventricular dysfunction (ejection fraction < 35%) (HR 1.9, p=0.0193) were included. The 10-year freedom from structural valve deterioration (SVD) at explant assessing the same age groups as survival was not different (p=0.081). The 10-year actual/actuarial freedom from SVD, at explant was for > or = 60 years--94.4+/-1.4% (85.2+/-3.9%), for > or = 65 years--94.2+/-1.4% (85.0+/-4.0%), for 61-70 years--97.4+/-2.6% (95.7+/-4.3%) and for > 70 years--94.0+/-1.5% (83.2+/-4.6%). The Mitroflow external mounted, pericardial aortic bioprosthesis with documented excellent haemodynamics (especially for the small aortic root), demonstrates that prosthesis-patient mismatch in moderate and severe categories can essentially be eliminated, with durability performance comparable to other heterograft (porcine and pericardial) bioprostheses.

CarboMedics Mitroflow Pericardial Aortic Bioprosthesis - Performance in Patients Aged 60 Years and Older after 15 Years

The purpose of this study was to carry out a current assessment of the Mitroflow pericardial bioprosthesis (model 11) according to the durability of the prosthesis after 15 years in patients aged 60 years or older. This bioprosthesis was implanted in 161 patients (mean age 69.5 +/- 6.3 years; range 60 - 94 years) undergoing aortic valve replacement (AVR) between 1982 and 1992. There were 84 patients aged 60 - 69 years (mean 64.5 +/- 3.1years) and 77 patients aged 70 years or older (mean 74.8 +/- 4.3 years). Of the total population, concomitant procedures were performed in 63 patients (39.1 %); of these, coronary artery bypass grafting was performed in 39 (24.2 %). Early mortality was 4.8 % (4 patients) in the 60 - 69 year age group and 10.4 % (8) in patients aged 70 years or older ( P = 0.290). Late mortality was 4.5 %/patient-year (35) for those aged 60 - 69 years and 8.1 %/patient-year (49) for those aged 70 years or older ( P = 0.007). Patient survival at 15 years of patients aged 60 - 69 years was 47.6 +/- 6.3 % and of patients aged 70 years or older was 20.9 +/- 5.4 % ( P = 0.003) ( ). Freedom from valve-related mortality for patients in the 60 - 69 year age group was 92.1 +/- 3.5 % at 15 years (0.6 %/patient-year [5]), and in the patient group aged 70 years or older it was 84.4 +/- 5.3 % (1.3 %/patient-year [8]; P = 0.194). Freedom from reoperation for patients in the 60 - 69 year age group was 73.9 +/- 5.0 % (2.6 %/patient-year [20]), and for patients aged 70 years or older it was 91.4 +/- 3.4 % (1.0 %/patient-year [6]; P = 0.029). The structural valve deterioration (SVD) rate for patients in the 60 - 69 year age group was 2.4 %/patient-year (19), and for patients aged 70 years or older it was 1.0 %/patient-year (6) ( P = 0.041). Actuarial freedom from structural valve deterioration at 15 years for patients aged 60 - 69 years was 62.0 +/- 7.3 %, and 80.8 +/- 7.9 % for patients aged 70 years and older ( P = 0.049) (actual freedom 73.9 +/- 5.2 % and 91.4 +/- 3.4 %, respectively). The Mitroflow pericardial bioprosthesis can still be recommended for aortic valve replacement in patients 70 years and older.

Twenty-two–year durability of Ionescu-Shiley pericardial aortic bioprosthesis implanted in a 49-year-old woman: A valuable insight into the performance of current pericardial bioprostheses

Twenty-two–year durability of Ionescu-Shiley pericardial aortic bioprosthesis implanted in a 49-year-old woman: A valuable insight into the performance of current pericardial bioprostheses

Hemodynamic stability during 17 years of the carpentier-edwards aortic pericardial bioprosthesis

Background. Long-term stability of the hemodynamic performance of commercially available Carpentier-Edwards stented bovine pericardial aortic bioprostheses (Perimount RSR) is unknown. To anticipate the fate of this bioprosthesis, we examined its hemodynamic performance up to 17 years using echocardiographic studies in a Premarket Approval cohort. Methods. Of 267 patients at four institutions in the Premarket Approval cohort, 85 had a total of 168 echocardiographic studies during a 17-year period of yearly follow-up examinations. These were reviewed and quantified in a core echocardiographic facility. Longitudinal data analysis was used to account for repeated, censored data. Results. Mean transvalvular gradient was inversely related to prosthesis size ( p = 0.01), and possibly ( p = 0.06) increased somewhat during the first 10 years of follow-up, then stabilized. Effective orifice area was larger in larger valve sizes ( p = 0.01), declined somewhat during the first 10 years, and then began to increase again. Ejection fraction declined minimally ( p = 0.2). In contrast to the rather stable hemodynamics, aortic regurgitation steadily increased from none to 1 to 2+ ( p = 0.005), but rarely (< 10% at 17 years) progressed to 3+ or 4+. Conclusions. The Carpentier-Edwards aortic pericardial bioprosthesis can be anticipated to have an acceptable long-term transvalvular gradient and effective orifice size that will change trivially up to 17 years after implantation. Mild aortic regurgitation will develop progressively. This anticipated hemodynamic resilience supports continued clinical use of the Perimount Carpentier-Edwards bovine pericardial stented bioprosthesis.

Age and valve size effect on the long-term durability of the Carpentier-Edwards aortic pericardial bioprosthesis

Background. 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. Methods. 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. Results. 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. Conclusions. Durability of this stented pericardial aortic bioprosthesis is excellent and justifies its use in patients aged 65 or older.