Percutaneous Heart Valve Research Articles

A Novel Low-Profile Self-Expanding Biodegradable Percutaneous Heart Valve Frame That Grows with a Child

According to rough estimates, one in every 125 newborns born in the United States has a congenital cardiac abnormality that must be repaired. With the recent development of new biomaterials and innovative treatment methods, percutaneous cardiac valve replacement has been considered as an alternative to surgical procedures. While percutaneous heart valve replacement is a relatively new procedure with a few commercially available devices, the devices are not sufficiently low-profile, and do not grow with the child. To address this issue, a novel low-profile growing percutaneous pediatric heart valve frame made of two types of unique metallic biomaterials (supere lastic nitinol and biodegradable iron) has been developed through this study. The developed pediatric heart valve frame has an innovative mechanism that will expand its diameter by disconnecting biodegradable metals, enabling the growth of the device with the surrounding tissue in the cardiac space. The thermally treated iron wires show stable and gradual degradation characteristics, showing approximately 7.66% for both wires treated under 350 and 450 °C. Polymer-coated wires show a degradation range of 4.96 to 5.55% depending on the type of coating. Degradation test results show the predicted 9–23 months of degradation depending on the type of surface treatment (e.g., thermal treatment, polymer coating), which is a suitable range when compared with the theoretical arterial vessel remodeling process period in the human vascular system. Radial forces calculated by finite element analysis and measured by mechanical testing matched well, showing 5–6 N with a 20% diameter reduction considering the deployed valve frame in the heart. Biocompatibility study results demonstrated superior cell viability in thermally treated iron wires after 3 days of cell culture and showed rarely found platelets on the surface after 3-h blood exposure tests. Prototype devices were successfully fabricated using optimized advanced joining processes for dissimilar metallic materials such as nitinol and iron. This study represents the first demonstration of self-expanding and biodegradable percutaneous heart valve frames for pediatric patients that grow with a child.

Exercise-based cardiac rehabilitation for adults after heart valve surgery.

The impact of exercise-based cardiac rehabilitation (CR) following heart valve surgery is uncertain. We conducted an update of this systematic review and a meta-analysis to assess randomised controlled trial evidence for the use of exercise-based CR following heart valve surgery. To assess the benefits and harms of exercise-based CR compared with no exercise training in adults following heart valve surgery or repair, including both percutaneous and surgical procedures. We considered CR programmes consisting of exercise training with or without another intervention (such as an intervention with a psycho-educational component). We searched the Cochrane Central Register of Clinical Trials (CENTRAL), in the Cochrane Library; MEDLINE (Ovid);Embase(Ovid); the Cumulative Index to Nursing and Allied Health Literature(CINAHL; EBSCO);PsycINFO (Ovid);Latin American Caribbean Health Sciences Literature(LILACS; Bireme);and Conference Proceedings Citation Index-Science (CPCI-S) on the Web of Science (Clarivate Analytics) on10January 2020. We searched for ongoing trials from ClinicalTrials.gov, Clinical-trials.com, and the World Health Organization International Clinical Trials Registry Platform on 15 May 2020. We included randomised controlled trials that compared exercise-based CR interventions with no exercise training. Trial participants comprised adults aged 18 years or older who had undergone heart valve surgery for heart valve disease (from any cause) and had received heart valve replacementor heart valve repair. Both percutaneous and surgical procedures were included. Two review authors independently extracted data. We assessed the risk of systematic errors ('bias') by evaluating risk domains using the 'Risk of bias' (RoB2) tool. We assessed clinical and statistical heterogeneity. We performed meta-analyses using both fixed-effect and random-effects models. We used the GRADE approach to assess the quality of evidence for primary outcomes (all-cause mortality, all-cause hospitalisation, and health-related quality of life). We included six trials with a total of 364 participants who have had open or percutaneous heart valve surgery. For this updated review, we identified four additional trials (216 participants). One trial had an overall low risk of bias, and we classified the remaining five trials as having some concerns. Follow-up ranged across included trials from 3 to 24 months. Based on data at longest follow-up, a total of nine participants died: 4 CR versus 5 control (relative risk (RR) 0.83, 95% confidence interval (CI)0.26 to 2.68; 2 trials, 131 participants; GRADE quality of evidencevery low). No trials reported on cardiovascular mortality. One trial reportedone cardiac-related hospitalisation in the CR group and none in the control group (RR 2.72, 95% CI0.11 to 65.56; 1 trial, 122 participants; GRADE quality of evidencevery low). We are uncertain abouthealth-related quality of life at completion of the intervention in CR compared to control (Short Form (SF)-12/36 mental component: mean difference (MD) 1.28, 95% CI-1.60 to 4.16; 2 trials, 150 participants;GRADE quality of evidencevery low; and SF-12/36 physical component: MD 2.99, 95% CI-5.24 to 11.21; 2 trials, 150 participants; GRADE quality of evidencevery low), or at longest follow-up (SF-12/36 mental component: MD -1.45, 95% CI-4.70 to 1.80; 2 trials, 139 participants; GRADEquality of evidencevery low; and SF-12/36 physical component: MD -0.87, 95% CI-3.57 to 1.83; 2 trials, 139 participants; GRADE quality of evidencevery low). AUTHORS' CONCLUSIONS: Dueto lack of evidence and the very low quality of available evidence, this updated review is uncertain aboutthe impact of exercise-CR in this population in terms of mortality, hospitalisation, and health-related quality of life. High-quality (low risk of bias) evidence on the impact of CR is needed to inform clinical guidelines and routine practice.

Bioengineered percutaneous heart valves for transcatheter aortic valve replacement: a comparative evaluation of decellularised bovine and porcine pericardia

Glutaraldehyde-treated, surgical bioprosthetic heart valves undergo structural degeneration within 10–15 years of implantation. Analogous preliminary results were disclosed for percutaneous heart valves (PHVs) realized with similarly-treated tissues. To improve long-term performance, decellularised scaffolds can be proposed as alternative fabricating biomaterials. The aim of this study was to evaluate whether bovine and porcine decellularised pericardia could be utilised to manufacture bioengineered percutaneous heart valves (bioPHVs) with adequate hydrodynamic performance and leaflet resistance to crimping damage.BioPHVs were fabricated by mounting acellular pericardia onto commercial stents. Independently from the pericardial species used for valve fabrication, bioPHVs satisfied the minimum hydrodynamic performance criteria set by ISO 5840-3 standards and were able to withstand a large spectrum of cardiac output conditions, also during extreme backpressure, without severe regurgitation, especially in the case of the porcine group. No macroscopic or microscopic leaflet damage was detected following bioPHV crimping.Bovine and porcine decellularized pericardia are both suitable alternatives to glutaraldehyde-treated tissues. Between the two types of pericardial species tested, the porcine tissue scaffold might be preferable to fabricate advanced PHV replacements for long-term performance. Condensed abstractCurrent percutaneous heart valve replacements are formulated with glutaraldehyde-treated animal tissues, prone to structural degeneration. In order to improve long-term performance, bovine and porcine decellularised pericardia were utilised to manufacture bioengineered replacements, which demonstrated adequate hydrodynamic behaviour and resistance to crimping without leaflet architectural alteration.

Development of a constitutive law for numerical simulation of artificial leaflet-structures for transcatheter heart valve prostheses

Abstract While the current generation of devices for minimally invasive treatment of severe symptomatic aortic valve stenosis is based on xenogenic leaflet-material, artificial polymeric leaflet-structures represent a promising approach for future improvement of heart valve performance. For enhanced long-term success of polymeric leafletstructures, limitations regarding calcification and durability have to be addressed. The objective of the presented study was the development of a constitutive law representing the material properties of artificial polymeric leaflet-structures of transcatheter heart valve prostheses in numerical simulation to assess the in silico leaflet-performance. Mechanical characterization of cast films and nonwoven specimens of a polycarbonate based silicone elastomer were conducted by means of uniaxial tension and planar shear testing, respectively. For validation purposes, experimental data were compared with the results of finite-element analysis (FEA) using different hyperelastic models. Strain energy function for third-order ogden hyperelastic model achieved the best fit of the non-linear stress-strain behavior of the isotropic polymeric material with the experimental data. It was chosen for further FEA of valve leaflet-performance under physiological pressurization to analyze the suitability of various manufacturing processes for polymeric leafletstructures. Therefore a specific leaflet-design with a wall thickness of 400 μm was used. As a result of FEA, time dependent leaflet-deformation, leaflet coaptation surface area (CSA) and leaflet opening area (LOA) of cast and nonwoven leaflet-structures were calculated. While LOA was comparable for cast and nonwoven leaflet-structures, obtained leaflet-dynamics in a cardiac cycle under physiological pressurization demonstrated crucial influence of the manufacturing process. For nonwoven leafletstructures, an enhanced CSA could be demonstrated in comparison to cast structures. FEA using a validated hyperelastic constitutive law represents a useful tool for in silico performance evaluation of polymeric leaflet-structures under physiological loading and proves the suitability of the polymeric artificial leaflet-material for percutaneous heart valve prostheses.

Percutaneous heart valve interventions: a South African perspective

Valvular heart disease represents a significant health care challenge in South Africa, mainly due to the prevalence of rheumatic fever. This review discusses the recent advances in percutaneous heart valve treatment, including heart valve replacement, as an alternative to open prosthetic valve replacement and it’s relevance in South Africa. Balloon mitral valvotomy is discussed with emphasis on patient selection, management during pregnancy and management in the presence of left atrial thrombus. Further developments regarding the percutaneous treatment of mitral valve disease include percutaneous treatment of mitral incompetence by annuloplasty via the coronary sinus and edge-to-edge repair with the aid of a mitral clip. Transcatheter aortic valve replacement is the more developed procedure and two valves have the CE mark of approval. Both have good short to medium term data demonstrating efficacy but are technically difficult to insert, very expensive and patient selection remains a major problem. Their use is thus limited to patients turned down for conventional surgery. Percutaneous pulmonary valve replacement has good evidence to show efficacy but its use is largely limited to patients with degenerated pulmonary outflow tract conduits.

CRT-700.11 Percutaneous repair and regeneration of native heart valves using a novel decalcification and bioelectric energy controlled stem cell homing and differentiation device

In the early 1990's our team developed and patented one of the first percutaneous heart valve systems working with Dr. Ivan Casagrande and Dr. Domingos Moraes in Brazil. We learned in this experience that a patient is nearly always better off keeping their own heart valve it they can. The aim of

Cardiocentro Ticino in Lugano, Switzerland.

A young cardiology centre with an ambitious agenda in basic and clinical research Created 16 years ago with the support of a private donation, the Cardiocentro Ticino is located in Lugano, a small town in the Italian speaking region of Switzerland, south of the Alps, 80 km north of Milan. The Cardiocentro Ticino is a non-profit medical centre for the treatment of patients with heart disease. It is the only existing centre of interventional cardiology and cardiac surgery in the region. The Cardiocentro currently has 400 collaborators. Since 2012, it has been an associate institute of the department of cardiology of the University Hospital of Zurich. Prof. Tiziano Moccetti the medical director of Cardiocentro Ticino also leads the department of cardiology together with Dr Giovanni Pedrazzini. Prof. Stefanos Demertzis is head of the department of cardiac surgery and Dr Tiziano Cassina is head of the department of cardiac anaesthesiology and intensive care unit. Dr Marco Moccetti leads the Division of Interventional Cardiology. Beyond percutaneous coronary interventions, this team routinely performs percutaneous heart valve procedures including transcatheter aortic valve implantation (TAVI) and the Mitra-Clip device implantation for severe mitral valve regurgitation, as well as percutaneous closure of patent foramen ovale, and hybrid interventions involving both interventional cardiology and cardiac surgery teams. The recent opening of a ‘radial lounge’ has increased the rate of coronary angiography procedures using a radial arterial approach up to 50%. ![Graphic][1] ![Graphic][2] ![Graphic][3] Dr Francesco F. Faletra leads the Division of cardiac imaging which … [1]: /embed/inline-graphic-1.gif [2]: /embed/inline-graphic-2.gif [3]: /embed/inline-graphic-3.gif

Early experience with the Venus p‑valve for percutaneous pulmonary valve implantation in native outflow tract.

IntroductionThe Venus p‑valve (MedTech, Shanghai, China) is a self-expanding percutaneous heart valve designed to be implanted in a native patched right ventricle outflow tract. The worldwide clinical experience with this valve is just beginning and the results have so far been encouraging. We present our initial early experience implanting the Venus p‑valve in the native right ventricle outflow tract of patients with Tetralogy of Fallot repaired with a transannular patch.MethodsIn 10 selected patients a procedure for percutaneous pulmonary valve implantation was performed using the Venus p‑valve. The patients mean age was 32 years (13–57), mean weight 59.6 kg (40–80). All patients had Tetralogy of Fallot with moderate to severe pulmonary regurgitation and an indication for pulmonary valve replacement.ResultsThe implantation procedure was successful in all the patients resulting in an immediately functional valve. No procedure-related complications were observed. Follow-up after 12 months (4–21) resulted in an improvement in NYHA class. There was a reduction of the mean right ventricle diastolic volume from 139 ml/m2 (105–179) to 78 ml/m2 (65–100) and improvement in the regurgitation fraction from 42% (29–58) to 1% (0–5), as seen on routine cardiac magnetic resonance 6 months after the implantation. No stent fractures have been observed so far.ConclusionPercutaneous pulmonary valve implantation with the Venus p‑valve resulted in a safe and effective procedure. The valve has predictable and sustained functional competence, resulting in clinical improvement in the patients.

Evaluation of MRI issues at 3-Tesla for a transcatheter aortic valve replacement (TAVR) bioprosthesis

ObjectiveReplacement of the aortic heart valve typically requires open-heart surgery. A new transcatheter aortic valve replacement (TAVR) bioprosthesis made from metallic material was recently developed that is an advantageous alternative insofar as it is implanted using a minimally invasive procedure. Because of the presence of metal, there are safety issues related to MRI. Therefore, the purpose of this study was to use standardized testing techniques to evaluate MRI issues for this TAVR bioprosthesis in association with a 3-Tesla MR system. MethodsThe TAVR bioprosthesis (Hydra Aortic Valve, Percutaneous Heart Valve Prosthesis, Vascular Innovations Company, Ltd, Thailand) was evaluated for magnetic field interactions (translational attraction and torque), MRI-related heating at a relative high specific absorption rate level (whole body average SAR, 2.9-W/kg), and artifacts (T1-weighted, spin echo, and gradient echo pulse sequences) at 3-Tesla. ResultsThe TAVR bioprosthesis demonstrated negligible magnetic field interactions (deflection angle, 3-degrees; torque, 0) and minimal heating (maximum temperature rise, 2.5°C; background temperature rise, 1.7°C). Artifacts were relatively small in relation to the size and shape of the implant. ConclusionsThe TAVR bioprosthesis that was evaluated in this investigation is acceptable, or using current MRI terminology “MR Conditional”, for a patient undergoing MRI at 3-Tesla or less.

Design considerations and quantitative assessment for the development of percutaneous mitral valve stent

Percutaneous heart valve replacement is gaining popularity, as more positive reports of satisfactory early clinical experiences are published. However this technique is mostly used for the replacement of pulmonary and aortic valves and less often for the repair and replacement of atrioventricular valves mainly due to their anatomical complexity. While the challenges posed by the complexity of the mitral annulus anatomy cannot be mitigated, it is possible to design mitral stents that could offer good anchorage and support to the valve prosthesis. This paper describes four new Nitinol based mitral valve designs with specific features intended to address migration and paravalvular leaks associated with mitral valve designs. The paper also describes maximum possible crimpability assessment of these mitral stent designs using a crimpability index formulation based on the various stent design parameters. The actual crimpability of the designs was further evaluated using finite element analysis (FEA). Furthermore, fatigue modeling and analysis was also done on these designs. One of the models was then coated with polytetrafluoroethylene (PTFE) with leaflets sutured and put to: (i) leaflet functional tests to check for proper coaptation of the leaflet and regurgitation leakages on a phantom model and (ii) anchorage test where the stented valve was deployed in an explanted pig heart. Simulations results showed that all the stents designs could be crimped to 18F without mechanical failure. Leaflet functional test results showed that the valve leaflets in the fabricated stented valve coapted properly and the regurgitation leakage being within acceptable limits. Deployment of the stented valve in the explanted heart showed that it anchors well in the mitral annulus. Based on these promising results of the one design tested, the other stent models proposed here were also considered to be promising for percutaneous replacement of mitral valves for the treatment of mitral regurgitation, by virtue of their key features as well as effective crimping. These models will be fabricated and put to all the aforementioned tests before being taken for animal trials.

Percutaneous heart valves; past, present and future

Percutaneous heart valves provide a promising future for patients refused surgery on the grounds of significant technical challenges or high risk for complications. Since the first human intervention more than 10 years ago, over 50 different types of valves have been developed. The CoreValve and Edwards SAPIEN valves have both experienced clinical trials and the latter has gained FDA approval for implantation in patients considered inoperable. Current complications, such as major vascular bleeding and stroke, prevent these valves from being commonly deployed in patients considered operable in conventional surgery. This review focuses on the past and present achievements of these valves and highlights the design considerations required to progress development further. It is envisaged that, with continued improvement in valve design and with increased clinical and engineering experience, percutaneous heart valve replacement may one day be a viable option for lower-risk operable patients.

Transcatheter heart valve based on a synthetic matrix for tissue engineering applications

Objective: Stented heart valve matrices are promising as prospective transcatheter heart valve prostheses. The aim of this study was to analyse the mechanical integrity of polymer-based percutaneous heart valve prostheses after crimping and perfusion.

Trans-Aortic Percutaneous Heart Valve Deployment of Impella CPTM to Assist in High-Risk Percutaneous Coronary Intervention

Trans-Aortic Percutaneous Heart Valve Deployment of Impella CPTM to Assist in High-Risk Percutaneous Coronary Intervention

Treatment of Severe Aortic Stenosis

Of 73 patients with severe AS who did not undergo AVR, 15 (14%) died at 15-month follow-up [12]. Of these 73 patients, symptoms were thought to be unrelated to the AS in 31 patients. Exercise stress tests for symptoms were performed in only 4% of the 42 asymptomatic patients. Asymptomatic patients with low-gradient severe AS and normal LVEF with reduced stroke volume index had at 46-month follow-up aortic valve events similar to those with normal stroke volume index [13]. Of 248 patients with severe AS and a normal LVEF, 94 had a lowgradient ( 40 mm Hg mean gradient) (group 3) [14]. Symptoms were present in 49% of group 1 patients, in 55% of group 2 patients, and in 60% of group 3 patients (p not significant). At 45-60-month follow-up, the incidence of AVR or death was 71% for group 1, 77% for group 2, and 76% for group 3 (p value not significant). Kaplan-Meier survival curves for time to death in all 3 groups were significantly better for patients with AVR versus no AVR [14]. E/E 1 lateral was an independent predictor of time to death in patients who did not receive AVR [15]. Percutaneous heart valve implantation may be performed in nonsurgical patients with end-stage calcific AS. In the Placement of Aortic Transcatheter Valves (PARTNER) trial, 699 high-risk patients with severe AS, mean age 84 years, were randomized to AVR or (transcatheter aortic valve replacement) TAVR [16]. All-cause mortality was 3.4% for the TAVR group versus 6.5% for the AVR group at 30 days (p value not significant) and 24.2% for the TAVR group versus 26.8% for the AVR group at 1 year (p value not significant). Major stroke was 3.8% for the TAVR group versus 2.1% for the AVR group at 30 days (p value not significant) and 5.1% for the TAVR group versus 2.4% for the AVR group at 1 year (p value not significant). Major vascular complications at 30 days were 11.0% for the TAVR group versus 3.2% for the AVR group (p<0.001). At 1-year, there were similar improvements in cardiac symptoms for both groups. In the PARTNER trial, among inoperable patients with severe AS, compared with standard care, TAVR caused significant improvements in health-related quality of life maintained for at least 1 year [17]. On the basis of the available data, AVR should be performed in operable patients with severe AS. However, TAVR should be performed in non-operable patients with symptomatic severe AS to improve survival and quality of life compared with medical management.

Percutaneous aortic valve replacement in a re-animated postmortem heart

Percutaneous valve interventions Percutaneous aortic valve replacement in a re-animated postmortem heart Jennifer K. White 1 *, MD; Amy Sun 2 ; Lauren Killien 2 ; Dennis Evangelista 2 1. Instructor of Surgery, Massachusetts General Hospital, Division of Cardiac Surgery, Boston, MA and Visiting Scientist, Massachusetts Institute of Technology (MIT), Department of Mechanical Engineering, Cambridge, MA, USA; 2. Graduate students, MIT, Department of Mechanical Engineering, Cambridge, MA, USA All authors have no conflict of interest. KEYWORDS Heart re-animation, heart valve testing, percutaneous valves, aortic valve replacement, postmortem heart, endoscopic. Aims The non-anatomical properties of conventional bench-top testing apparatus hinder the pre-clinical testing of percutaneous heart valve technology. The aim of this work was to construct a system that integrates a mechanically re-animated post-mortem heart with an artificial circulation and multi-modality imaging to further enable the study of percutaneous heart valve therapies. Methods and results Model A fresh postmortem swine heart (300g) was excised from the animal's chest and cannulated with an 18 mm clear polyvinyl tube in the ascending aorta. The inferior pulmonary vein was incised to allow the inser- tion of a 30 mm clear PVC medical grade tube. A 12.5 mm fluid-tight trocar was positioned in the superi- or pulmonary vein (Thoracoport™, Norwalk, CT). All tubes and trocars were secured in the tissue using 0-silk suture and the chain technique. A 12.5 mm fluid-tight trocar with a side-port for a pressure trans- ducer was positioned in the apex of the left ventricle using a pledgeted 0-silk pulse string secured with a tourniquet. * Corresponding author: Division of Cardiac Surgery, Massachusetts General Hospital, Bullfinch 119/50 Fruit St., Boston, MA 02114, USA E-mail: jkwhite@partners.org © Europa Edition 2006. All rights reserved. EuroIntervention Supplements (2006) 1 (Supplement A) A19-A23 - A19 -

Protocolo de indicaciones quirúrgicasde las valvulopatías

Although in the Western world valvular heart diseases are less frequent than ischemic heart diseases, in Spain valvular pathology requires more frequent intervention than ischemic disease. In recent years, the emergence of percutaneous heart valve implants and the improvement of surgical valve repair techniques, have changed therapeutic approaches in the treatment of valvulopathies. An increasing numbers of elderly patients are being referred and time new surgical risk factors have been proposed. Several guidelines have been published in order to help physicians to select the best possible surgical management strategies for the individual patient suffering from valvular heart disease.

Design and finite element-based fatigue prediction of a new self-expandable percutaneous mitral valve stent

Percutaneous heart valve replacement is currently limited to the replacement of pulmonary and aortic valves in a targeted group of patients. Designing a heart valve for mitral valve replacement is further limited by its distinctive anatomical feature, which places a constraint on its range of design options. To overcome such limitations, the objectives of this study were to use computational modeling and simulation to design a new nitinol-based mitral valve stent and evaluate its crimpability and fatigue behavior. A self-expandable stent with new features that could address the issues of valve migration and paravalvular leaks was generated using the CAD-based conceptual modeling. Its expansion, crimpability, deployment patterns, and fatigue behavior were simulated and analyzed. Our simulations incorporated cyclic cardiac muscle loading, cyclic blood pressure loading, as well as cyclic valve-leaflet forces in the fatigue life assessment for mitral valves. Our results showed that the stent model passed the fatigue test under the aforementioned loading conditions. Our model provides a simple, fast and cost-effective tool to quantitatively determine the fatigue resistance of stent components. This is of great value to the design of new prosthetic heart valve models, as well as to surgeons involved in valve replacement.

Transcatheter aortic valve‐in‐valve implantation of a corevalve in a degenerated stenotic sapien heart valve prosthesis

Treatment options for re-stenotic aortic valve prosthesis implanted by transcatheter technique have not been evaluated systematically. We describe the case of a 75-year-old dialysis patient who was treated by transcatheter aortic valve implantation 3.5 years ago and now presented with severe stenosis of the percutaneous heart valve. The patient was initially treated with a trans-apical implantation of an Edwards Sapien 26 mm balloon expandable valve. The patient remained asymptomatic for 3 years when he presented with increasing shortness of breath and significant calcification of the valve prosthesis on transesophageal echocardiography. Valve-in-valve percutaneous heart valve implantation using a 26-mm CoreValve prosthesis was performed under local anesthesia. The prosthesis was implanted without prior valvuloplasty. Pacing with a frequency of 140/min was applied during placement of the valve prosthesis. Positioning was done with great care using only fluoroscopic guidance with the aim to have the ventricular strut end of the CoreValve prosthesis 5 mm higher than the ventricular strut end of the Edwards Sapien prosthesis. After placement of the CoreValve prosthesis within the Edwards Sapien valve additional valvuloplasty with rapid pacing was performed in order to further expand the CoreValve prosthesis. The final result was associated with a remaining mean gradient of 5 mm Hg and no aortic regurgitation. In conclusion, implantation of a CoreValve prosthesis for treatment of a restenotic Edwards Sapien prosthesis is feasible and is associated with a good functional result.

TCT-110 First Experience With A Novel Anatomically Adapted Percutaneous Heart Valve For The Tricuspid Position

TCT-110 First Experience With A Novel Anatomically Adapted Percutaneous Heart Valve For The Tricuspid Position

TCT-823 In-Vitro Assessment Of The Influence Of Oval Annuli On The Hydrodynamic Function Of Percutaneous Heart Valve Prostheses

CT- analyses of patient data show that the majority of annuli of patients suffering from severe aortic stenosis are oval in shape. Current percutaneous heart valve prostheses are circular and in-vitro tests for CE-Mark approval are only performed in circular annulus models. In an effort to create a