Caged-ball Valve Research Articles

Design and Development of Caged Ball Heart Valve Using Solid Works

Currently, over 2, 90,000 heart valve surgeries are performed worldwide annually and that number is estimated to triple by 2050. Even though patients with prosthetic valves lead a life relatively free from symptoms, problems like physiological complications and valve failure are significant. To date, all mechanical heart valves are plagued with complications associated with hemolysis and coagulation. These complications are believed to be associated with non-physiological blood flow patterns in the vicinity of the artificial heart valves. The geometry of the valve prosthesis with respect to the mitral valve annulus may significantly affect the flow dynamics in the human heart. It is thus essential to assess the hemodynamics of mitral prosthetic caged ball valve to improve the design of the device. This research work presents a 3D model of the left human heart with optimized mitral caged ball valve engineered by a computational tool (SolidWorks 2009). The performance of the valve like hemodynamics across the valve, stress analysis and physical properties like mass, surface area, etc. is assessed virtually. This limits the need to perform extensive, costly and timeconsuming in-vitro and animal tests. Thus optimization of the caged ball heart valve design facilitates reduction of flow-induced thrombogenicity and reduces the need for post-implant anticoagulants.

Durability Beyond Our Wildest Dreams: The Caged-Ball Valve at 60 Years.

Knowing our surgical history does more than provide terrain for moral contemplation and a sense of identity for our cardiothoracic specialty. Probing the human endeavor also provides a window into the continuum of our collective experience. The 1950s saw the beginnings of modern cardiothoracic surgery, with nearly every segment of the aorta successfully replaced during the decade. However, treatment of diseased aortic and mitral valves was essentially limited to commissurotomy, and there was no truly curative surgical technique available at the time. It was not until 1960 that surgical replacement of cardiac valves was made possible.1–3 That year, Dwight Harken and Albert Starr first used caged-ball devices to replace the aortic and mitral valves within months of each other.2,3 The development of the caged-ball valve was one of the marvels of 20th-century medical science.When Starr (only 30 years old at the time of his innovative collaboration with 60-year-old engineer Lowell Edwards) reflected on the development of the Starr-Edwards valve, he attributed its rapid advance from bench to bedside to several factors present in 1960 but not in today's medical environment.4 One was freedom from oversight: the United States Food and Drug Administration was not focused on medical devices at the time, and there were no institutional review boards, informed consent requirements, or ethical guidelines for human subject research. As a result, Starr and Edwards were able to move rapidly through multiple iterations of the caged-ball valve—first in animals, then in humans. Surprisingly, this pioneering spirit laid the groundwork for the subsequent development of numerous iterations of cardiac valves: continued modification of the ball-and-cage valves, Alain Carpentier's use of the porcine tissue valve and the other bioprosthetic valves that followed, and the evolution of mechanical valves that eventually culminated in pyrolytic carbon bileaflet mechanical valves.5In this issue of the Texas Heart Institute Journal, De Martino and associates6 trace the history of a true milestone in cardiac surgery, the evolution of the caged-ball prosthesis. Their historical review provides valuable knowledge to everyone from nascent medical students to clinicians in the later years of their cardiovascular careers. It is also an amazing testament to the pioneering spirit of Harken and Starr that has led to the various iterations of the caged-ball and subsequent valves, provided so many patients with decades of functional life, and ultimately transformed the treatment of valvular disease in millions.Funding/support: Dr. Coselli's work is partly supported by the Cullen Foundation. Dr. Coselli consults for, receives royalties and a departmental educational grant from, and participates in clinical trials for Terumo Aortic; consults and participates in clinical trials for Medtronic, Inc., and W.L. Gore & Associates; and serves as a co-investigator for CytoSorbents.

The Caged-Ball Prosthesis 60 Years Later: A Historical Review of a Cardiac Surgery Milestone.

Sixty years ago, 2 cardiac operations dramatically influenced the survival of patients with valvular heart disease. The replacement of an aortic valve by Dwight Harken and of a mitral valve by Albert Starr with mechanical caged-ball valves, both in 1960, was a true milestone in the history of cardiac surgery and the beginning of a long journey toward prosthetic valve replacement full of expectations, hopes, and dreams fulfilled. Caged-ball prostheses underwent numerous modifications in design and materials to improve reliability and prevent specific mechanical and thrombogenic complications. Clinical and pathologic experience gained during the past 6 decades has enabled the development of safe, durable, and minimally thrombogenic mechanical prostheses.

DESIGN AND DEVELOPMENT OF IMPURITIES FREE PYROLYTIC COATED MECHANICAL BI-LEAFLET HEART VALVE PROTOTYPE

Heart valve problems affect more than 100 million people worldwide. According to statistics, around 55% of valvular diseases are treated by a mechanical prosthesis. The first heart valve replaced model was the caged-ball valve, more than 50 models of heart valves designed by different companies. Each design has different aspects such as valve geometry, leaflets design, materials used for model manufacturing, coating techniques, and coating materials. Depending on the patient's need and condition, the native heart valve either replaced by a biological or mechanical heart valve. Biological valves are made of living tissues whereas mechanical valves manufactured by the biomaterials, which are biocompatible and do not causes any reaction inside the body. The prototype discussed in this paper provides good hemocompatibility, because of the biomaterial used in this prototype manufacturing. It will reduce tissue ingrowth, due to the enhanced leaflet ear of the orifice ring. Moreover, it will cause less thrombotic effects into the host due to greater contact angel of graphite and smooth surface of graphite after pyrolytic coating. The significant evolution of mechanical valve designs consists of valve geometry, coating technique, and materials. In this research, the 3D-CAD model of Bileaflet Mechanical Mitral Heart Valve was designed using SOLID WORKS 2016 and fabricated by 5-axis Computer Numeric Control (CNC) machine. Graphite was used for the fabrication of prototype and Pyrolytic Carbon (PyC) coating was performed with Chemical Vapor deposition (CVD) technique. Scanning electron microscopy (SEM), Fourier Transform Infrared Spectroscopy (FTIR), and X-ray Diffraction (XRD) were used to determine the effects of CVD on surface topography and chemical structure of graphite model before and after coating. Furthermore, hemocompatibility of graphite and PyC analyzed through in-vitro hemolytic activity. The Characterization results showed that the Bileaflet Mechanical Mitral Heart valve prototype after PyC coating provides a smooth surface with improved hemocompatibility and less adhesion. Besides, the Mechanical Heart valves showed no hemolysis during the hemolytic activity. By virtue of its smooth and nonporous surface, it is antithrombotic and provides good hemodynamics. The advance long leaflet ear design reduces the tissue ingrowth around the orifice which will further limit the leaflets movement.

A 51-year-old Starr–Edwards caged-ball valve

A 51-year-old Starr–Edwards caged-ball valve

Is a Mechanic Prosthetic Valve in Tricuspid Position an Absolute Impediment to Implant a Definitive Electrode in the Right Ventricle?

This is the case of a middle-aged woman with Ebstein anomaly, who had a tricuspid valve replacement with a mechanic Starr-Edwards caged-ball valve many years ago, and needed an implantable cardioverter defibrillator (ICD) and ventricular pacing due to ventricular tachycardia and atrioventricular block with syncope. Furthermore, she has a chronic respiratory disease that make open chest surgery inadvisable. Prosthetic valves are a real obstacle to cross them and place catheters in the distal chamber. This report shows a technique to get access to the right ventricle endocardium through the annulus and placing the ICD electrode with correct sensing and pacing.

Timing of anticoagulant re-initiation following intracerebral hemorrhage in mechanical heart valves: Survey of neurosurgeons and thrombosis experts

BackgroundWhile oral anticoagulation (OAC) is universally indicated for patients with mechanical heart valves (MHVs), OAC resumption following anticoagulant-associated intracerebral hemorrhage (ICH) is an area of uncertainty. We sought to determine the practice preferences of North American neurosurgeons and thrombosis experts on optimal timing of OAC re-initiation. MethodsA cross-sectional survey was disseminated to North American members of the American Association of Neurological Surgeons and the International Society for Thrombosis and Haemostasis. Demographic factors, as well as a clinical scenario with 14 modifiable clinical risk factors were included in the survey. Results504 physicians completed our survey (response rate 34.3%). Majority of participants were affiliated with academic centres, and managed≤10 ICH patients with MHV per year. There was wide distribution in response in optimal timing for OAC resumption following an ICH: 59% and 60% preferred to re-start OAC between 3 and 14 days following the hemorrhagic event (median of 6–7 days). Smaller hemorrhages (<30cm2). CHADS2 score ≥2, concomitant venous thromboembolism, mitral valve prosthesis, caged-ball valves and multiple valves prompted earlier OAC resumption. ConclusionWide variation in the current practice of neurosurgeons and thrombosis specialists exist when they encounter patients with ICH and MHV, though decisions were influenced by patient- and valve-related factors. As our observed variation likely reflects the immense gap in current evidence, prospective randomized trials in this population are therefore urgently needed.

A left heart ventricle simulator manufactured by 3D printing

Mechanical circulatory assistance devices have been researched and used to assist the pumping function of the failing heart. Examples of these devices are intra-aortic balloon pumps (IABP) and ventricular assist devices (VAD). In order to perform the in vitro tests of these devices, before the in vivo tests, cardiovascular simulators are required. One important part of a cardiovascular simulator is the simulation of the left ventricle which is a pulsatile blood pump. Most of the existing left ventricle simulators use pneumatic actuator. This type of actuator creates negative pressure inside the ventricle chamber which is not physiological. The objective of this work is to develop a pulsatile pump that simulates the left ventricle without creating negative pressure. The concept of the pulsatile pump was evaluated using 3D printing to manufacture the prototype. The developed pulsatile pump is composed of two reservoirs: a rigid one with 5.0 x 10 4 mm 3 of volume which corresponds to the residual systolic volume and a flexible one which ejects 8.0 x 10 4 mm 3 of fluid per beating cycle when compressed by a platform. Two caged-ball valves simulating the mitral and the aortic valve are responsible for the unidirectional flow. A constant pressure of 1,333 Pa inside an open reservoir maintains the fluid flowing into the pulsatile pump through the mitral valve. A DC motor is connected to a lever mechanism that transforms the rotational movement of the motor into vertical movement of the platform. The vertical movement of the platform is responsible for the pulsatile flow of the pump, generating a pressure of 10,640 to 15,960 Pa at the outlet of the pump. Since the platform is not attached to the flexible reservoir, there is no generation of the negative pressure inside the simulator.

A 39-year-old woman with silent endocarditis of a caged-ball mitral valve

A 39-year-old woman with a caged-ball mechanical mitral valve prosthesis (Star Edward, implanted 1994 in India after mitral valve endocarditis) was admitted to our hospital with suspected infective endocarditis due to persistent fever >38°C and Staphylococcus aureus in blood culture. Owing to a …

Paraprosthetic leak closure 28 years after mitral caged-ball Starr-Edwards implantation

In this case report, we present a patient 28 years after mitral valve replacement with the Starr-Edwards prosthesis complicated by periprosthetic leak with severe aortic stenosis and moderate tricuspid regurgitation. We successfully repaired the periprosthetic regurgitation in a patient with extensive mitral annular calcification, without replacement of the valve. No apparent structural deterioration on the caged-ball valve was found. Moreover, aortic valve replacement and tricuspid annuloplasty were performed. One month after reoperation, the patient remained stable with improved clinical status and without any evidence for further paravalvular leak.

Caged-ball mitral valve: still functional after 40 years

Caged-ball mitral valve: still functional after 40 years

Long-term durability of Starr–Edwards ball valve

The long-term durability of classical caged ball valves in comparison with tilting disc valves and bileaflet valves is attracting much interest. An example of a mitral Starr– Edwards ball valve model 6120 implanted in May 1969 and removed at autopsy in June 2009 (40 years later) is reported here. The patient was a 38-year-old woman suffering from mitral stenosis and secondary tricuspid regurgitation. She received successful mitral valve replacement and tricuspid valve repair, and did well for a long time without major complications, including cerebral thromboembolism. Multiple small spots of lipid infiltration were observed on the surface of the brownish-yellowed silicone rubber ball of the explanted ball valve. There were no cracks or distortion. The metallic cage was also free from structural deterioration. However, the outlet orifice of the caged valve (ventricular site) was partially occluded by thick pannus (autologous tissue growth) around the metallic struts (Figs. 1, 2). It has been reported that caged ball valves explanted after long-term implantation (28, 37, and 39 years) were, at the time of reoperation, free from structural deterioration other than minor color change and lipid infiltration [1–3]. These cases suggest that silastic caged ball valves with Teflon sewing cuff might have excellent long-term durability under specific conditions, including normal left ventricular function without rhythm disturbance. It may be worth reconsidering the durability of prosthetic heart valves on the basis of results from long-term implantation.

A 44-year experience of prosthetic heart valve implantation at Niigata University Hospital

Based on a single hospital experience of heart valve implantation from 1965 to 2009, the superiority of prosthetic heart valves including Starr-Edwards caged ball valves, Omniscience aortic tilting disc valves, and St. Jude Medical bileaflet valves are reviewed. This review discusses the prominent antithrombogenicity of the Starr-Edwards model 1200 aortic prosthesis under selected conditions, the relatively rarely thrombosed (despite its decreased opening angle) Omniscience aortic valve, the long-term outcomes 10 as well as 30 years after St. Jude Medical valve replacement, and finally the latest results on the significance of patient-aortic prosthesis mismatch in relation to myocardial hypertrophy. The findings described here should be considered in further investigations of cardiac valve prostheses.

Starr-Edwards valves at the aortic and mitral positions implanted for 39 years

Cloth-covered Starr-Edwards caged ball valves implanted in the aortic and mitral valve positions for 39 years were extracted. Both showed valve dysfunction resulting from pannus overgrowth. The metal cages of the Starr-Edwards valves were covered with worn cloth. This case indicates the extended durability of Starr-Edwards valves and the importance of the design and materials of prosthetic heart valves to avoid pannus overgrowth and prosthetic valve abrasion.

「血管内手術の現状と今後の展望」 心臓弁膜症に対するカテーテル人工弁治療

Since the first successful valve replacement using the caged-ball valve, numerous engineering modifications have been made to enhance hemodynamic performance and durability of the artificial valve. Currently, various types of artificial valves are available are implemented depending on patient characteristics and need for surgical valve replacement. Bioprosthesis has the advantage of a low thromboembolism rate without warfarin, however, structural valve deterioration is a disadvantage. On the other hand, a mechanical valve has superior durability compared to the bioprosthesis. However, mechanical valve use requires life-long anticoagulant therapy. Recently a catheter-delivery heart valve, classified as a bio-prosthesis, has been implanted in patients outside Japan.

Giant left atrium in a patient with Starr–Edwards caged ball implanted three decades ago

The Starr–Edwards caged ball valve is one of the oldest cardiac valve prostheses and was widely used all around the world in the past decades [1]. Few patients are reported to have lived with Starr–Edwards prosthesis for 30 years or longer. A 64-year-old woman was admitted to our hospital with complaints of dyspnea on exertion (NHYA Class III), abdominal distention, peripheral swelling, and diminished appetite. She underwent mechanical mitral replacement with Starr–Edwards caged ball valve prosthesis due to rheumatic mitral valve disease (predominantly severe mitral regurgitation) at age 34. She underwent DDD-R pacemaker implantation 5 years ago due to syncope resulting from sick sinus syndrome. On resting ECG basic rhythm was atrial fibrillation. The patient was well anticoagulated with INR value of 3.7. On transthoracic echocardiogram, the silicon ball was free to travel along the cage over a distance of 1 cm, although high peak velocity (2.5 m/s) accompanied with 8 mmHg of mean gradient and 130 ms of pressure half time was observed on transthoracic echocardiography examination. The latter also demonstrated a giant left atrium with dimensions of 15×12 cm, severe tricuspid insufficiency associated with pulmonary hypertension (systolic pulmonary arterial pressure=75 mmHg), and reduced right ventricular systolic functions. Occluder motion was normal, and no

Recommendations for Evaluation of Prosthetic Valves With Echocardiography and Doppler Ultrasound: A Report From the American Society of Echocardiography's Guidelines and Standards Committee and the Task Force on Prosthetic Valves, Developed in Conjunction With the American College of Cardiology Cardiovascular Imaging Committee, Cardiac Imaging Committee of the American Heart Association, the European Association of Echocardiography, a registered branch of the

Recommendations for Evaluation of Prosthetic Valves With Echocardiography and Doppler Ultrasound: A Report From the American Society of Echocardiography's Guidelines and Standards Committee and the Task Force on Prosthetic Valves, Developed in Conjunction With the American College of Cardiology Cardiovascular Imaging Committee, Cardiac Imaging Committee of the American Heart Association, the European Association of Echocardiography, a registered branch of the

Prosthetic Heart Valves

The introduction of valve replacement surgery in the early 1960s has dramatically improved the outcome of patients with valvular heart disease. Approximately 90 000 valve substitutes are now implanted in the United States and 280 000 worldwide each year; approximately half are mechanical valves and half are bioprosthetic valves. Despite the marked improvements in prosthetic valve design and surgical procedures over the past decades, valve replacement does not provide a definitive cure to the patient. Instead, native valve disease is traded for “prosthetic valve disease,” and the outcome of patients undergoing valve replacement is affected by prosthetic valve hemodynamics, durability, and thrombogenicity. Nonetheless, many of the prosthesis-related complications can be prevented or their impact minimized through optimal prosthesis selection in the individual patient and careful medical management and follow-up after implantation. The purpose of this article is to provide an overview of the current state of knowledge and future perspectives with regard to optimal prosthesis selection and clinical management after valve implantation. The ideal valve substitute should mimic the characteristics of a normal native valve. In particular, it should have excellent hemodynamics, long durability, high thromboresistance, and excellent implantability. Unfortunately, this ideal valve substitute does not exist, and each of the currently available prosthetic valves has inherent limitations. ### Mechanical Valves Three basic types of mechanical valve design exist: bileaflet, monoleaflet, and caged ball valves (Figure 1A, 1B, and 1C). Figure 1. Different types of prosthetic valves. A, Bileaflet mechanical valve (St Jude); B, monoleaflet mechanical valve (Medtronic Hall); C, caged ball valve (Starr-Edwards); D, stented porcine bioprosthesis (Medtronic Mosaic); E, stented pericardial bioprosthesis (Carpentier-Edwards Magna); F, stentless porcine bioprosthesis (Medtronic Freestyle); G, percutaneous bioprosthesis expanded over a balloon (Edwards Sapien); H, self-expandable percutaneous bioprosthesis (CoreValve). #### Caged Ball Valves Caged ball valves, which consist of a silastic ball with a circular sewing ring and a …

Fluid mechanics of artificial heart valves.

1. Artificial heart valves have been in use for over five decades to replace diseased heart valves. Since the first heart valve replacement performed with a caged-ball valve, more than 50 valve designs have been developed, differing principally in valve geometry, number of leaflets and material. To date, all artificial heart valves are plagued with complications associated with haemolysis, coagulation for mechanical heart valves and leaflet tearing for tissue-based valve prosthesis. For mechanical heart valves, these complications are believed to be associated with non-physiological blood flow patterns. 2. In the present review, we provide a bird's-eye view of fluid mechanics for the major artificial heart valve types and highlight how the engineering approach has shaped this rapidly diversifying area of research. 3. Mechanical heart valve designs have evolved significantly, with the most recent designs providing relatively superior haemodynamics with very low aerodynamic resistance. However, high shearing of blood cells and platelets still pose significant design challenges and patients must undergo life-long anticoagulation therapy. Bioprosthetic or tissue valves do not require anticoagulants due to their distinct similarity to the native valve geometry and haemodynamics, but many of these valves fail structurally within the first 10-15 years of implantation. 4. These shortcomings have directed present and future research in three main directions in attempts to design superior artificial valves: (i) engineering living tissue heart valves; (ii) development of advanced computational tools; and (iii) blood experiments to establish the link between flow and blood damage.

A Braunwald-Cutter valve: a mitral prosthesis at 33 years

We present a case of a 76-year-old woman with a Braunwald-Cutter mitral caged-ball valve prosthesis excised after 33 years post implantation due to a paravalvular leak. The valve itself was intact and fully functional. We believe the longevity of this valve was due to the decreased flow velocities and the lower pressure in the mitral valve position.