Pericardial Valve Research Articles

Six-month results of a repositionable and retrievable pericardial valve for transcatheter aortic valve replacement: The Direct Flow Medical aortic valve

Transcatheter aortic valve implantation is considered an alternative for patients at high risk for conventional surgery. The Direct Flow Medical aortic valve (Direct Flow Medical, Inc, Santa Rosa, Calif) is a nonmetallic tissue valve prosthesis intended to treat patients with severe aortic stenosis at high risk for surgery. Thirty-one patients at high surgical risk were enrolled in the trial (logistic EuroSCORE 28% ± 7%, Society of Thoracic Surgeons score 23% ± 9%). Twenty-two patients underwent successful retrograde transcatheter aortic valve implantation, and 9 patients did not undergo implantation owing to excessive calcifications or access issues. Mean preinterventional gradient and effective orifice area were 49 ± 14 mm Hg and 0.54 ± 0.16 cm(2), respectively, and 71% of patients were in New York Heart Association functional class III. Mean postprocedural gradient was 14.9 ± 5.5 mm Hg with an effective orifice area of 1.4 ± 0.31 cm(2). Two patients were converted to surgery and 2 patients died after implantation: 1 of myocardial infarction and 1 of congestive heart failure. One patient had a stroke 2 days after the procedure and 3 patients required a pacemaker. At 6 months the mean aortic valve gradient and effective orifice area were 19.8 mm Hg and 1.30 cm(2), respectively. The majority of patients had no paravalvular leak (58%) and 42% had grade 1/4 paravalvular leak; 69% were in New York Heart Association functional class I and 25% were in class II. The 3- and 6-month survivals were 87.1% and 80.6%, respectively (4/6 deaths in 31 patients). Transcatheter aortic valve implantation using the study valve appears safe and results are promising at 6 months. Severe leaflet and left ventricular outflow tract calcification affects procedural outcome; therefore, careful patient selection is crucial.

Compound Heterozygous Desmoplakin Mutations Result in a Phenotype with a Combination of Myocardial, Skin, Hair, and Enamel Abnormalities

Desmoplakin (DP) anchors the intermediate filament cytoskeleton to the desmosomal cadherins and thereby confers structural stability to tissues. In this study, we present a patient with extensive mucocutaneous blisters, epidermolytic palmoplantar keratoderma, nail dystrophy, enamel dysplasia, and sparse woolly hair. The patient died at the age of 14 years from undiagnosed cardiomyopathy. The skin showed hyperplasia and acantholysis in the mid- and lower epidermal layers, whereas the heart showed extensive fibrosis and fibrofatty replacement in both ventricles. Immunofluorescence microscopy showed a reduction in the C-terminal domain of DP in the skin and oral mucosa. Sequencing of the DP gene showed undescribed mutations in the maternal and paternal alleles. Both mutations affected exon 24 encoding the C-terminal domain. The paternal mutation, c.6310delA, leads to a premature stop codon. The maternal mutation, c.7964 C to A, results in a substitution of an aspartic acid for a conserved alanine residue at amino acid 2655 (A2655D). Structural modeling indicated that this mutation changes the electrostatic potential of the mutated region of DP, possibly altering functions that depend on intermolecular interactions. To conclude, we describe a combination of DP mutation phenotypes affecting the skin, heart, hair, and teeth. This patient case emphasizes the importance of heart examination of patients with desmosomal genodermatoses.

Simulated Thin Pericardial Bioprosthetic Valve Leaflet Deformation Under Static Pressure-Only Loading Conditions: Implications for Percutaneous Valves

Percutaneous aortic valve (PAV) replacement is currently being investigated as an endovascular alternative to conventional open-chest valve surgery for patients with severe aortic stenosis. The results of multi-center clinical trials of PAV devices have been encouraging. However, there are serious adverse events associated with this procedure. Furthermore, long-term durability and safety of PAV need to be studied carefully. In this study, we developed a thin pericardial bioprosthetic valve model, which has similar design features of PAV. We utilized this model to investigate PAV deformation under static, pressure-only loading conditions using Finite Element method. Mechanical properties of PAV leaflet were obtained from planar biaxial testing of glutaraldehyde treated thin bovine pericardium (BP) and porcine pericardium (PP), and characterized by the Fung-elastic model. Simulations were performed to examine the effects of tissue thickness and anisotropy on the valve deformation and stress distribution. The results indicated peak stress and strain occurred in the vicinity of commissures. The peak maximum principal stresses (MPS) were reduced with the increase of leaflet tissue thickness, by 36% and 59% from the mean thickness to 0.35 mm for BP and PP, respectively. The PAV with BP leaflet had a lower peak MPS than that with PP leaflet. Moreover, leaflet material orientation had a significant influence on the peak MPS of PAV.

Finite Element Investigation of Stentless Pericardial Aortic Valves: Relevance of Leaflet Geometry

Recent developments in aortic valve replacement include the truly stentless pericardial bioprostheses with single point attached commissures (SPAC) implantation technique. The leaflet geometry available for the SPAC valves can either be a simple tubular or a complex three-dimensional structure molded using specially designed molds. Our main objective was to compare these two leaflet designs, the tubular vs. the molded, by dynamic finite element simulation. Time-varying physiological pressure loadings over a full cardiac cycle were simulated using ABAQUS. Dynamic leaflet behavior, leaflet coaptation parameters, and stress distribution were compared. The maximum effective valve orifice area during systole is 633.5 mm(2) in the molded valve vs. 400.6 mm(2) in the tubular valve, and the leaflet coaptation height during diastole is 4.5 mm in the former, in contrast to 1.6 mm in the latter. Computed compressive stress indicates high magnitudes at the commissures and inter-leaflet margins of the tubular valve, the highest being 3.83 MPa, more than twice greater than 1.80 MPa in the molded valve. The molded leaflet design which resembles the native valve exerts a positive influence on the mechanical performance of the SPAC pericardial valves compared with the simple tubular design. This may suggest enhanced valve efficacy and durability.

Twenty-six-year durability of an Ionescu–Shiley standard profile pericardial aortic valve

The Ionescu-Shiley pericardial valve (Shiley, Inc, Irvine, CA, USA) is a first generation bioprosthesis made from bovine pericardium. Despite its excellent hemodynamic performance, use of this prosthesis ceased because it had an unacceptably high rate of early structural deteriorations, especially in the era of the standard profile valve. We experienced a rare case of very long durability of an Ionescu-Shiley standard profile (ISSP) bioprosthesis.

3f Prosthesis Aortic Cusp Replacement: Implantation Technique and Early Results

Stentless aortic bioprostheses have been successfully used for over a decade. The 3f bioprosthesis is a new equine pericardial stentless valve, unique in its tubular design, preserving the native aortic sinuses post-implant. Forty-six consecutive aortic valve replacements with the 3f bioprosthesis were performed between June 2003 and January 2005. The patients were prospectively assessed and echocardiography was performed at 6 months, 12 months, and annually thereafter. The median follow-up was 2.1 + or - 0.9 years. There was one early and 4 late deaths; none were valve-related. The 2-year mean transvalvular gradient was 8.8 + or - 3.8 mm Hg, the mean echocardiographic aortic regurgitation grade was 0.4 + or - 0.7 (grade 1 being trivial). Echocardiographic sizing of the aortic annulus before surgery accurately predicted prosthesis size. The 3f bioprosthesis is easy to implant. Early clinical results are favorable, with hemodynamic profiles consistent with those of other stentless prostheses. Longer follow-up is required to confirm its durability.

Explantation of a 44-year-old Starr–Edwards mitral valve for delayed hemolysis

FIGURE 1. Starr–Edwards 44-year-old explanted mitral valve, model 6120, with sewing ring removed. Valve is intact, with yellowing of ball. CLINICAL SUMMARY A 68-year-old woman was admitted 44 years after undergoing mitral valve replacement with a Starr–Edwards (SE) prosthesis (Edwards Lifesciences, Irvine, Calif) for rheumatic mitral valve stenosis. Since implantation of the prosthesis in 1965 via thoracotomy, the patient had done well and maintained her anticoagulation with warfarin sodium (Coumadin). She now had fatigue and anemia. Of note, 2 years earlier the patient had had third-degree heart block necessitating the implantation of a dual-chamber pacemaker. A full workup including upper and lower endoscopy did not reveal a source of bleeding. Hematologic testing showed decreased haptoglobin, a high lactic dehydrogenase value, and increased reticulocyte count, consistent with a hemolytic anemia. Bone marrow biopsy was performed, which showed erythroid hyperplasia, normocellular bone marrow, normal megakaryocytes, and absent iron, indicative of iron deficiency anemia. Despite iron replacement therapy she continued to become increasingly transfusion dependent. She received 9 units of blood in 1 month alone. Echocardiogram revealed normal prosthetic mitral valve function with a mitral valve mean gradient of 6 mm Hg, a severely calcified aortic valve with an aortic valve mean gradient of 58 mm Hg, and an aortic valve area of less than 1.0 cm. Aortic and mitral valve replacements were performed with bioprosthetic valves. Reoperative median sternotomy was performed. After standard cannulation, Sondergaard’s groove was used to expose the mitral valve. The SE valve was in good condition without paravalvar leak. The mitral valve was explanted. The SE ball and cage were undamaged (Figure 1). There was no evidence of cloth tears or pannus overgrowth. The color of the ball had changed, presumably from lipid infiltration, but the ball was otherwise without pitting or defects. The patient underwent successful aortic valve replacement with a 21-mm Edwards Magna Thermafix bovine pericardial valve (Edwards) and mitral valve replacement with a 25-mm St Jude Epic porcine valve (St Jude Medical, Inc, St Paul, Minn). The patient was discharged

Are stentless valves hemodynamically superior to stented valves? Long-term follow-up of a randomized trial comparing Carpentier–Edwards pericardial valve with the Toronto Stentless Porcine Valve

The benefit of stentless valves remains in question. In 1999, a randomized trial comparing stentless and stented valves was unable to demonstrate any hemodynamic or clinical benefits at 1 year after implantation. This study reviews long-term outcomes of patients randomized in the aforementioned trial. Between 1996 and 1999, 99 patients undergoing aortic valve replacement were randomized to receive either a stented Carpentier-Edwards pericardial valve (CE) (Edwards Lifesciences, Irvine, Calif) or a Toronto Stentless Porcine Valve (SPV) (St Jude Medical, Minneapolis, Minn). Among these, 38 patients were available for late echocardiographic follow-up (CE, n = 17; SPV, n = 21). Echocardiographic analysis was undertaken both at rest and with dobutamine stress, and functional status (Duke Activity Status Index) was compared at a mean of 9.3 years postoperatively (range, 7.5-11.1 years). Clinical follow-up was 82% complete at a mean of 10.3 years postoperatively (range, 7.5-12.2 years). Preoperative characteristics were similar between groups. Effective orifice areas increased in both groups over time. Although there were no differences in effective orifice areas at 1 year, at 9 years, effective orifice areas were significantly greater in the SPV group (CE, 1.49 +/- 0.59 cm(2); SPV, 2.00 +/- 0.53 cm(2); P = .011). Similarly, mean and peak gradients decreased in both groups over time; however, at 9 years, gradients were lower in the SPV group (mean: CE, 10.8 +/- 3.8 mm Hg; SPV, 7.8 +/- 4.8 mm Hg; P = .011; peak: CE, 20.4 +/- 6.5 mm Hg; SPV, 14.6 +/- 7.1 mm Hg; P = .022). Such differences were magnified with dobutamine stress (mean: CE, 22.7 +/- 6.1 mm Hg; SPV, 15.3 +/- 8.4 mm Hg; P = .008; peak: CE, 48.1 +/- 11.8 mm Hg; SPV, 30.8 +/- 17.7 mm Hg; P = .001). Ventricular mass regression occurred in both groups; however, no differences were demonstrated between groups either on echocardiographic, magnetic resonance imaging, or biochemical (plasma B-type [brain] natriuretic peptide) assessment (P = .74). Similarly, Duke Activity Status Index scores of functional status improved in both groups over time; however, no differences were noted between groups (CE, 27.5 +/- 19.1; SPV, 19.9 +/- 12.0; P = .69). Freedom from reoperation at 12 years was 92% +/- 5% in patients with CEs and 75% +/- 5% in patients with SPVs (P = .65). Freedom from valve-related morbidity at 12 years was 82% +/- 7% in patients with CEs and 55% +/- 7% in patients with SPVs (P = .05). Finally, 12-year actuarial survival was 35% +/- 7% in patients with CEs and 52% +/- 7% in patients with SPVs (P = .37). Although offering improved hemodynamic outcomes, the SPV did not afford superior mass regression or improved clinical outcomes up to 12 years after implantation.

Successful Medical Treatment of Bioprosthetic Pulmonary Valve Endocarditis Caused by Methicillin-Resistant Staphylococcus aureus

The mortality risk of prosthetic valve endocarditis is known to be increased in cases in which staphylococci are the causative organisms. Previous recommendations have concentrated on early surgical management of this condition, but there are now reports that these infections can be treated medically, thus leaving prosthetic material in situ. We describe a case of methicillin-resistant Staphylococcus aureus endocarditis on a bovine pericardial pulmonary valve that responded to antibiotic therapy without the need for surgical intervention.

Early results of aortic valve reconstruction with stentless glutaraldehyde treated autologous pericardial valve

Introduction Aortic valve reconstruction (AoR) using single strip of autologous glutaraldehyde treated pericardium is a substitute for aortic valve replacement. We present our early results with the use of this technique.

Transvalvular leakage after the implantation of stented bovine pericardial valves is not only central

Transvalvular leakage after the implantation of stented bovine pericardial valves is not only central

TCT-77: 12 Months and Beyond: Long-Term Results of the Direct Flow Medical Repositionable and Retrievable Pericardial Valve for Percutaneous Aortic Valve Replacement

TCT-77: 12 Months and Beyond: Long-Term Results of the Direct Flow Medical Repositionable and Retrievable Pericardial Valve for Percutaneous Aortic Valve Replacement

Acute Fibrin Deposition Causing Acute Failure of Two Tissue Pericardial Valves

We report the early failure of two tissue valves within hours of surgery due to the accumulation of cellular debris in two different institutions in the United Kingdom. The valves were both found at explant to be covered in a cellular material - possibly fibrin. From clinical experience and careful review of the literature we have found no other reports of such early valve failure due to the build up of material on the structure of the valve. This rare occurrence needs to be reported in the literature to forewarn clinicians of an early complication that may not be recognized yet.

Experimental evaluation of the JenaClip transcatheter aortic valve

Transcatheter techniques of aortic valve replacement are a treatment option for valvular heart disease in high-risk surgical candidates. We evaluated a self-expanding valve system with a novel mechanism of fixation in an experimental setting in an acute animal model and ex vivo in aortic root specimens. A self-expanding nitinol stent containing a pericardial tissue valve was implanted in a transapical approach in 15 sheeps. The valve was introduced under fluoroscopic guidance through a 22F sheath by means of a specially designed delivery catheter. Deployment was performed on the beating heart without cardiopulmonary bypass or rapid ventricular pacing and facilitated by positioning feelers anchoring the device to the native aortic cusps. To investigate release and anchoring of the device during retrograde implantation, the stent was also implanted in aortic root specimens obtained from an autopsy series. In animal experiments, stent deployment was primarily successful in 12 (80%) animals. Positioning feelers facilitated implantation by confirming the correct implantation plane of the stent and anchoring to the native aortic cusps. If primary location was not satisfactory the stent was retracted into the catheter and repositioned. After successful implantation no significant changes of hemodynamics were observed. Two animals (13%) developed ventricular fibrillation early in this experimental series due to displacement of one positioning element into a coronary ostium, major regurgitation was observed in two animals. Ex vivo evaluation of the device in aortic root specimens proved feasibility of stent release and leaflet fixation; ex vivo implantation was successful in all cases. In this study, we demonstrate feasibility of a leaflet-fixation device in nondiseased aortic valves. The JenaClip provides an effective concept of fixation with positioning feelers that allows exact positioning without outflow obstruction and anchoring the valve to the native leaflets. Further studies are necessary to investigate this concept in diseased aortic valves.

Technique of Transcatheter Aortic Valve Implantation with the Edwards-Sapien® Heart Valve Using the Transfemoral Approach

Transcatheter aortic valve implantation (TAVI) using a balloon-expandable valve has been developed by the authors' group 7 years ago to offer a therapeutic solution to nonoperable or surgical high-risk patients with degenerative aortic stenosis. The technique and the devices used have rapidly evolved thereafter and TAVI has become a clinical reality with more than 3,500 patients implanted worldwide with this device. The currently used Edwards-Sapien Transcatheter Heart Valve (THV) consists of a balloon-expandable stent with an integrated bovine pericardial valve. It can be implanted within the diseased native aortic valve using either the retrograde transfemoral or antegrade transapical routes. This article is aimed at describing the updated transfemoral technique. Appropriate patient selection is crucial for a successful procedure including close evaluation of the arterial characteristics. After predilatation of the native valve with a balloon catheter, the THV with its delivery system is introduced within the femoral artery, advanced to the native aortic valve under X-ray control, positioned across the aortic annulus, and delivered by balloon inflation under rapid heart pacing. The acute procedural success is 96% and the technique leads to an immediate and lasting improvement of hemodynamics and clinical status. Complications are rare and the mortality rate is 6.3% at 1 month in this cohort of very sick patients. Procedural complications are headed by vascular injury related to the large size of the arterial introducers. An upcoming lower- profile Edwards THV should improve this issue and increase the indication for this less invasive approach in the near future. At the present time, the indications should be restricted to nonoperable or surgical high-risk patients and the procedure performed by experienced and formally trained physicians working in an optimal multidisciplinary environment.

Incidence, detection, and management of cardiac metastasis in pediatric sarcoma patients

10060 Background: Sarcoma metastasizing to the heart is a difficult and complicated clinical problem, yet local control is feasible and effective for select patients with cardiac metastasis. Diligence is required to detect these lesions while still amenable to treatment, and echocardiogram remains the best tool for detecting cardiac disease. Methods: We reviewed all echocardiograms (1330) performed on 307 pediatric sarcoma patients treated at UT M. D. Anderson Cancer Center between 1997 and 2008. Measures of cardiac function and pathology (including size of ventricles and atria, function of ventricles and valves, presence of metastasis, and presence of pericardial effusion) were assigned numerical values. Fisher's exact test and the Wilcoxon rank-sum test compared clinical characteristics of patients with and without cardiac metastases. Results: The prevalence of cardiac metastases was 1.6% (5/307) with 95% confidence interval 0.5% to 3.8%. The presence of cardiac metastasis positively correlated with pericardial effusion (p = 0.001) and tricuspid valve insufficiency (p = 0.014). The probability of a patient with pericardial effusion having a cardiac metastasis was 28.6% (95% CI: 3.7%-71%). Of the 5 patients with documented sarcoma metastasis to the heart, 3 had widespread refractory disease, were given no cardiac-specific therapy, and rapidly died from disease. One patient who had widespread disease controlled with chemotherapy and radiation had open resection of 2 cardiac metastases which resulted in site-specific disease control for 6 months before succumbing to progressive extra-cardiac disease. Another patient had isolated cardiac metastasis, treated with open resection of 2 metastases followed by adjuvant chemotherapy, and has been without recurrent cardiac metastases for 5 years and 9 months. Conclusions: Durable local control for sarcoma metastasizing to the heart is possible and effective for select patients. Pericardial effusion merits evaluation for potential associated cardiac metastasis. Echocardiogram monitoring of sarcoma patients remains important, and should include screening for possible cardiac metastasis. No significant financial relationships to disclose.

Modified Bentall Operation With Bioprosthetic Valved Conduit: Columbia University Experience

A conduit was made by sewing a bovine pericardial valve into a graft conduit with the pseudo-sinuses of Valsalva. The graft collar below the valve cuff ring was sewn to the aortic annulus with interrupted pledgeted sutures. From August 2005 to February 2008, 68 patients underwent aortic root replacements with this technique. Operative mortality was 2.9% (2 acute aortic dissection patients died). During median follow-up of 11 months, 1 patient had reoperation for conduit failure due to infectious endocarditis. This technique is safe and feasible with favorable early outcomes. Because the valve is sewn above the outflow tract, superior hemodynamics are achieved. Reoperation may be accomplished by removal of the valve rather than full root re-replacement.

Off-pump transapical mitral valve replacement☆

Percutaneous valve replacement was recently introduced, and reports of early clinical experience have already been published. To date, this technique is limited to the replacement of pulmonary and aortic valves in a strictly selected group of patients. The aim of this study was to analyse a self-expanding valved stent for minimally invasive replacement of the mitral valve in animals. A newly designed nitinol stent was specially designed for this experimental acute study. It comprised of a left ventricular tubular stent with star shaped left atrial anchoring springs and carried a trileaflet bovine pericardial valve. A polytetrafluoroethylene membrane was sutured to envelop the atrial springs and the outside of the ventricular stent. The ventricular anchoring system was the same as in our previously reported results with a similar mitral valved stent. Seven pigs underwent minimally invasive off-pump mitral valved stent implantation. This was performed through a lower mini-sternotomy and a standard transapical approach under transoesophageal echocardiographic (TEE) guidance was used. The valved stent is fully retrievable and precise deployment and accurate adjustment of its intra-annular position is achievable to eliminate paravalvular leakage. The deployment time ranged from 127 to 255s and the blood loss from 70 to 220cc. One animal died of intractable ventricular fibrillation. Mitral regurgitation in all surviving animals was minimal (trace in 5/6 and mild in 1/6 during echo examination; on the contrast ventriculogram no mitral insufficiency was observed except in one documented as mild paravalvular regurgitation). These animals remained haemodynamically stable (6/6) and without TEE or ventriculographic changes for 1h. Implantation of a tricuspid bovine pericardial valved stent in the mitral position is feasible in pigs through a transcatheter approach. This was possible through a smaller delivery system than previously reported. Additional studies are required to demonstrate long-term feasibility, durability, and heart function.

Bidirectional Glenn with Existing Transvenous Cardioverter-Defibrillator Leads

The population of patients with adult congenital heart disease is increasing. A significant number of these patients already have or will require placement of either a transvenous pacemaker or implantable cardioverter defibrillator. In addition to this, some with right ventricular dysfunction might benefit from volume unloading of the right ventricle by the construction of a superior cavopulmonary anastomosis. The usual technique for the bidirectional Glenn anastomosis precludes the presence of upper extremity transvenous hardware. We present a modified technique for the superior cavopulmonary anastomosis when pacing or cardioverter defibrillator leads are present.

Impact of Energy Loss Coefficient on Left Ventricular Mass Regression in Patients Undergoing Aortic Valve Replacement: Preliminary Observation

The purpose of this study was to evaluate the impact of Doppler-derived energy loss coefficient (ELCo) on the regression of left ventricular (LV) hypertrophy after aortic valve replacement (AVR) in patients with severe aortic stenosis. Twenty-four patients with severe aortic stenosis who underwent AVR with Carpentier-Edwards pericardial bioprosthetic valves (valve size 19 mm, n = 16; valve size 21 mm, n = 8) were examined. Within 12 months after AVR, follow-up echocardiography and Doppler measurements were performed. The effect of AVR was quantified on the basis of absolute and relative LV mass regression. There were significant correlations between indexed ELCo and absolute (r = 0.50, P = .013) and relative (r = 0.48, P = .018) LV mass regression. The mean value of relative LV mass regression was 25%, and a cutoff value of 0.9 cm2/m2 for indexed ELCo could detect patients with relative LV mass regression > 25% after AVR with sensitivity of 71% and specificity of 100%. ELCo, which can be calculated noninvasively from echocardiography, might be an important value to relate to LV mass regression in patients after AVR.