Clinical validation of a new drug seeking Food and
|
|
- Vincent Bridges
- 6 years ago
- Views:
Transcription
1 THE STATISTICIAN S PAGE Prosthetic Heart Valves: Objective Performance Criteria Versus Randomized Clinical Trial Gary L. Grunkemeier, PhD, Ruyun Jin, MD, and Albert Starr, MD Providence Health System, Portland, Oregon The current Food and Drug Administration (FDA) heart valve guidance document uses an objective performance criteria (OPC) methodology to evaluate the clinical performance of prosthetic heart valves. OPC are essentially historical controls, but they have turned out to be an adequate, and perhaps optimal, study design in this situation. Heart valves have a simple open-and-close mechanism, device effectiveness is easy to document, and the common complications (thromboembolism, thrombosis, bleeding, leak, and infection) are well known and easily detected. Thus, randomized clinical trials (RCTs) have not been deemed necessary for the regulatory approval of prosthetic heart valves. The OPC are derived from the average complication rates of all approved heart valves. Studies based on OPC have been shown to work well; many different valve models have gained FDA market approval based on this methodology. Although heart valve RCTs are not required by the FDA, they have been done to compare valves or treatment regimens after approval. Recently, the Artificial Valve Endocarditis Reduction Trial (AVERT) was designed to compare a new Silzone sewing ring, designed to reduce infection, with the Standard sewing ring on a St. Jude Medical heart valve. This was the largest heart valve RCT ever proposed (4,400 valve patients, followed for as long as 4 years), but it was stopped prematurely because of a high leak rate associated with the Silzone valve. Examining the results showed that a much smaller, OPC-based study with 800 patient-years would have been sufficient to disclose this complication of the Silzone valve. (Ann Thorac Surg 2006;82:776 80) 2006 by The Society of Thoracic Surgeons Clinical validation of a new drug seeking Food and Drug Administration (FDA) approval requires a definitive randomized control trial (RCT). Prosthetic heart valve replacement devices have been in use since 1960, and many different models have been granted market approval by the FDA. Yet none of these FDA approvals required a RCT. Instead, the FDA currently relies on a sort of composite historical control, the objective performance criteria (OPC). That may seem strange, but we will argue that it is probably as it should be. See pages 773 and 1140 In doing so, we will do the following: present some general remarks about prosthetic heart valve devices; briefly describe their FDA regulatory history and the current guidelines; summarize heart valve RCTs in general and one large recent example in detail; and discuss the rationale for using OPC rather than RCT to justify their clinical approval. Herein we present the rationale for using the OPC approach as opposed to RCTs for the evaluation and approval of prosthetic heart valves. Prosthetic Heart Valves A heart valve is a one-way check valve, opening to allow the flow of blood in one direction at the appropriate time Address correspondence to Dr Jin, 9155 SW Barnes Rd, LL Suite 33, Portland, OR 97225; ruyun.jin@providence.org. during the cardiac cycle, and sealing the valve orifice otherwise, to prevent backward flow. The first successful heart valve was the simple Starr-Edwards caged-ball device implanted in 1960 [1]. Engineering principles could be applied to the design, laboratory testing to assess flow, leak, strength, durability, and animal implantations to study the effects in a biological environment. This feedback loop resulted in rapid development and continual incremental improvements, resulting in a valve that has been used successfully for more than 40 years [2]. This type of progress would be impossible to achieve in today s regulatory environment. In the meantime, many other heart valve designs have been successfully introduced into clinical use. The most widely used to date is the St. Jude Medical (SJM) valve, with more than 1.5 million valves implanted by 2004 [3]. Clinical Results Many valve designs have been tried and abandoned at the in vitro or in vivo testing stages, or after unsatisfactory clinical usage. Those that are successful clinically have been relatively effective, as measured by diagnostic laboratory examinations: they open sufficiently to allow good forward flow and close adequately to prevent backward flow. And they are relatively safe, as measured by low rates of clinical complications. During the past 45 years, these complications, and the rates achieved by acceptable valves, have become well known. The complications have been codified in guidelines for reporting on heart valve performance, with standardized definitions simultaneously published in the United States [4, 5], 2006 by The Society of Thoracic Surgeons /06/$32.00 Published by Elsevier Inc doi: /j.athoracsur
2 Ann Thorac Surg THE STATISTICIAN S PAGE GRUNKEMEIER ET AL 2006;82: PROSTHETIC HEART VALVE OPC VERSUS RCT 777 Table 1. Objective Performance Criteria (OPC) a and Patient-Year (P-Y) b Requirements Europe [6], and Asia [7]. A comprehensive literature review covering 165 reported series, using 21 different valve models and comprising 61,455 valve implants and 319,749 patient-years of follow-up demonstrated that these complications rates tend to cluster around common values [8]. Regulatory Developments Mechanical Tissue OPC P-Y OPC P-Y Thromboembolism Valve thrombosis 0.8 1, ,850 All hemorrhage Major hemorrhage ,078 All paravalvular leak Major paravalvular leak 0.6 1, ,617 Endocarditis a Events per 100 valve-years (%/year). b Patient-years required to satisfy the requirement of establishing that the observed rate is less than 2 times the OPC, with power 0.80 and size The FDA began regulating medical devices in At first, there was no standard for clinical performance, marketing applications seemed to be judged primarily on the completeness of data. Then a 1993 guidance document (revised in 1994 [9]) gave requirements for in vitro, animal, and clinical data, including New York Heart Association (NYHA) class, blood and hemodynamic data, and cardiovascular complications [10, 11]. This document included the list of OPC for valve-related complications (Table 1). The OPC are estimates of the average complication rates, based on the reports of previously approved heart valves. Current Implementation of OPC A new heart valve must be shown to have complications rates that are equivalent to the OPC. Specifically, the 1994 FDA heart valve guidance requires the sponsor to demonstrate that the observed rates for the study valve are significantly less than 2 times the OPC [9]. That is, equivalence is defined as better than twice as bad. This requirement is formulated in terms of a one-sided hypothesis test, with a size of 0.05 and a power of 0.80 [10, 11]. The OPC rates for the various complications range from 0.3% per year to 3.5% per year, and the number of patient-years thus required to fulfill the equivalency requirement range from 277 to 4,850 (Table 1). The number of patient-years needed to cover all events was deemed prohibitive, so the value of 800 patient-years was selected, to include the 9 (of 14) OPC rates equal to or greater than 1.2% per year. Many premarket approval applications (PMAs) for heart valves have been approved using the OPC approach [12]. Heart Valve RCTs Although RCTs of heart valves have not been required for FDA approval, many have been done to compare postapproval valves. We will briefly review a few of the most important ones. There are two major randomized studies of heart valves, both comparing mechanical to tissue valves. A recent RCT compared the most-used third-generation SJM bileaflet valve to the firstgeneration Starr-Edwards caged-ball valve. And the largest RCT of heart valves ever proposed, a recent comparison of a new sewing ring treatment, ended prematurely because of an increased risk, which could have been predicted by a much smaller OPC-based study. Tissue Versus Mechanical There are considered to be two major heart valve RCTs, the Edinburgh [13] and the Veterans Administration [14] studies, both comparing mechanical to tissue valves. After 12 to 15 years, they reported what had already been known for many years from numerous observational studies that tissue valves are associated with more reoperation and mechanical valves have more bleeding due to the required anticoagulant therapy. And, by the time these trials were completed, the valves used were no longer being manufactured. In fact, this was probably not the ideal comparison for a randomized study, because the valves chosen have known characteristics that make clinical equipoise unlikely. Mechanical valve failure rates are essentially zero, whereas tissue valve failure is inevitable if the patient lives long enough. But the failure rate is slower for tissue valves the older the patient, so they should be used preferentially in older patients. Mechanical valve patients have to take anticoagulant medication, which increases the risk of bleeding and imposes lifestyle limitations, whereas only a relatively small subset of tissue valves will need to do so. Thus, there are different complication profiles for the two valves, with one usually being clearly advantageous for an individual patient. Even for patients in whom the lifetime expectations of these complications is the same, most patients would still have an opinion about a constant risk of a bleeding complication versus a probable reoperation in the future. New Versus Old Among mechanical valves, the caged-ball valve is considered first generation, the single-disk valve is second generation, and the bileaflet valve is third generation. An RCT was recently completed, comparing the original silicone rubber, ball-valve technology (Starr-Edwards) to the pyrolytic carbon, bileaflet technology (SJM) [15]. These two completely different solutions to the same mechanical problem gave virtually identical clinical results out to 5 years. That two such different valvular mechanisms can be equally effective and safe supports the concept of the commonality of complications rates that is the basis of the OPC approach. In this respect, heart valves may be unique. In what other type of medical intervention would a 1960 and a 1977 technology
3 778 THE STATISTICIAN S PAGE GRUNKEMEIER ET AL Ann Thorac Surg PROSTHETIC HEART VALVE OPC VERSUS RCT 2006;82: be finally subjected to an RCT that is published in 2003, with the resulting conclusion of no clinical differences? Artificial Valve Endocarditis Reduction Trial The largest heart valve RCT ever proposed was the Artificial Valve Endocarditis Reduction Trial (AVERT). We will use it to demonstrate the large size requirements of an RCT, and to contrast it with the OPC approach. The SJM valve was approved by the FDA in The SJM valve with a silver-impregnated sewing ring (called the Silzone valve), designed to reduce the risk of infection, was approved in 1998 as a supplement to the original PMA. Since it was only a sewing ring modification, a full OPC-based clinical study was not required. That would seem to be the ideal use of an RCT for two similar, post market-approval valves: SJM valves with Silzone versus Standard sewing ring. The risk of endocarditis was assumed to be 0.5% per year with the Standard sewing ring valve, and the AVERT was designed to detect a 50% risk reduction with Silzone. For a size of 0.05 and power of 0.80, it required the accrual of 4,400 patients over a 3-year induction period, with an additional year of follow-up [16]. The study began in July 1998, including 17 centers in North America and Europe. Owing to an unexpected risk of explant for paravalvular leak in the Silzone arm [17], recruitment was stopped in January 2000 and the Silzone valve was discontinued, but follow-up continues to further delineate the valve s performance characteristics. Fig 1. Cumulative patient-years of follow-up (smooth, almost identical curves, indexed by the left vertical axis) and the number of major leaks (dashed step functions, indexed by the right vertical axis) for the Silzone and Standard arms of the Artificial Valve Endocarditis Reduction Trial. The scale of the left axis is 100 times that of the right axis, so that the cumulative leak curve from a valve with a rate of 1 leak per 100 patient-years (1%/year) would fall directly on top of its cumulative follow-up curve. The dotted horizontal line indicates the objective performance criteria follow-up requirement of 800 patient-years, and the unshaded area on the left indicates the follow-up observed by that time, during which there were 14 and 3 leaks in the Silzone and Standard valve arms of the study, respectively (height of the black circles, as read on the right vertical axis). Fig 2. Major leak rates with 90% confidence intervals (horizontal axis), after 800 valve-years, for various numbers of observed events (vertical axis). The dashed vertical line indicates the objective performance criteria (OPC) of 0.6%/year for major paravalvular leak. The Food and Drug Administration criterion for approval is that the upper limit of the confidence interval is less than two times the OPC (the solid vertical line). The Silzone arm (14 leaks) of the study violates the acceptance criterion, and the Standard arm (3 leaks) satisfies it (identified by the two thicker horizontal lines). Note that the upper limit of a two-sided 90% confidence interval, as plotted in this figure, is the same as the limit of a one-sided 95% confidence interval, as required by the FDA guidance document. The AVERT study, when finished, would have included more than 10,000 patient-years. Ironically, a much smaller OPC-based study, with 800 patient-years, would have been sufficient to identify the increased Silzone risk of major leak. The cumulative follow-up years and number of major leaks for each arm of the study through July 2005 is shown in Figure 1. By the time 800 patient-years had accrued in each arm of the study, there were 3 major leaks in the Standard arm and 14 major leaks in the Silzone arm. Figure 2 shows the leak rates and their 90% confidence intervals, on the horizontal axis, produced by varying numbers of major leaks in 800 patient-years, on the vertical axis. Figure 2 shows that the leak rate with the Silzone valve is significantly higher than the OPC (fails the OPC test). Figure 2 also shows that the Standard valve passes the OPC test, as its leak rate is significantly less than twice the OPC. Fortunately, the excess risk with Silzone has disappeared over time, and the risk by about 2 years after implant is equal to that of the Standard valve [18]. In actuality, the AVERT trial was stopped in January 2000, long before 800 patient-years were accrued with the Silzone valve (there was a potential of about 300 patientyears by that time, as can be seen from Fig 1). By that time, there were 9 major leaks reported for Silzone and 3 for the control. Thus, it can be seen from Figure 2 that, even if 800 patient-years had been accumulated without any more major leaks, the Silzone valve still would not have passed the OPC test (by strict interpretation, only 4 events are permitted). That raises the issue of a sequential, rather than fixed sample size study, which could well be more appropriate for medical devices.
4 Ann Thorac Surg THE STATISTICIAN S PAGE GRUNKEMEIER ET AL 2006;82: PROSTHETIC HEART VALVE OPC VERSUS RCT 779 Rationale for OPC: Drugs Versus Devices There are major differences between drugs and heart valves, which may explain why RCTs are required for regulatory approval of the former, but not the latter. The evaluation stages of drug studies are (1) establish safety, (2) refine dosage, and (3) confirm efficacy. The last step is difficult because usually the mechanism of action is systemic, complex, and not well understood, and the endpoints are partly subjective. Consequently, many patients are needed, with randomization and blinding necessary to avoid bias. Also, drug treatment is temporary and reversible; the patient can discontinue the inferior drug and crossover to the other treatment. Indeed, crossover is often a planned element in a drug study design, but cannot be considered in a heart valve study. With many devices, and heart valves in particular, determining effectiveness is less problematic. The mechanism is simple, local, and well understood. The evaluation stages are establish efficacy (there is no dosage), and confirm safety. The endpoints are objective, there is no placebo effect, study patients are relatively few, and the treatment is permanent. Masking/blinding cannot be used, and there are problems with establishing a control. Some authors have argued that observational studies are not necessarily inferior to RCTs [19] and that careful observational studies can yield the same conclusions as RCTs [20]. Arguments can be made in favor of observational studies for heart valves [21], and some clinicians agree that RCTs are not ideal in this setting [22, 23]. Others have concluded that the results from RCTs do not generally reflect real-life clinical situations [24]. Over the years, prospective observational studies have preformed well in the evaluation of artificial heart valves. The Silzone valve was not subjected to a clinical study for regulatory approval but, by the analysis presented above, if one had been done, it would have failed the OPC test for major paravalvular leak. The OPC method depends on identifying all valverelated complications, including those that cause death, so that a high autopsy percentage must be a pivotal requirement of the study. That may not be as important in an RCT, since total mortality and sudden unexplained deaths can be compared between the study and control groups. Because there are no OPC for these events, it is important that fatal valve-related events be classified into the OPC category to which they belong. A requirement for using simple OPC rates (percent per year) to summarize a complication is that its risk is constant across time. When this assumption is true, it does not matter how long the follow-up times are. A 5-year follow-up of 160 patients and a 6-month follow-up of 1,600 patients, for example, both yield 800 patient-years. But if a complication is time-related, then not only does the constant risk assumption not hold, but the length of follow-up can be critical. An example is structural failure of bioprosthetic heart valves. That is not an OPC complication because it has an increasing risk, and to provide useful estimates of it would take follow-up times (12 to 15 years?) that are impractical given the development cycle of new valve technology. For these reasons, the OPC approach may not be appropriate for all medical devices. Conclusions and Future Developments The OPC approach has been shown to work well for regulatory approval of heart valves. Randomized clinical trials are not required for establishing their acceptability for clinical use. However, more sophisticated single-arm observational studies could be developed, possibly using Bayesian methods (Appendix), as previously suggested for heart valves [25] and coronary artery stents [26]. The FDA has considered and approved medical devices based on studies using Bayesian methods [27, 28], and just released a Draft Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials [29]. The next revision of the clinical requirement of the FDA guidance document for heart valves might incorporate such techniques. The authors are grateful to the reviewers of this editorial for insightful suggestions that improved its presentation and content. Appendix Bayesian Statistics The basic difference between the Bayesian and the more commonly used frequentist statistical approaches exists at the interface between philosophy and science [12]. Bayesian methods are older, have better theoretical properties, and are more intuitive. Frequentist methods rely only on the data produced in a given experiment to draw conclusion, while Bayesian methods formally integrate previously available information into the process (as we all do when making a decision). A simple example: suppose you have a jar full of red and black jellybeans and want to estimate the percentage of red, based on the first 10 jellybeans you draw of which 7 are red and 3 are black. In the absence of any other information, your best estimate of the percentage of red jellybeans in the jar would be 70%. Now suppose you have a coin and want to guess the true percentage of heads based on the first 10 tosses of which 7 are heads and 3 are tails. The data are the same, but do you really believe the chance of heads is 70%? No, because your prior experience with coins tells you that the true probability is very unlikely to be this extreme. A Bayesian would incorporate past experience with coins into her estimate to arrive at a percentage somewhere between 50% and 70%. This intuitive property has caused Bayesian methods to be used for many years in the interpretation of diagnostic tests [30]. Another advantage that Bayesian statisticians enjoy is a completely flexible stopping rule in a clinical trial, so that the AVERT Data Safety and Monitoring Board would have had a firm basis for stopping the trial prematurely, rather than the agonizing process they no doubt went through. And Bayesians are allowed to make direct probability statements about the results, such as the probability that the true value is between X and Y is 95%. These are not possible with frequentist methods, though most investigators erroneously interpret confidence intervals this way. Wide use of Bayesian techniques has been held back by the
5 780 THE STATISTICIAN S PAGE GRUNKEMEIER ET AL Ann Thorac Surg PROSTHETIC HEART VALVE OPC VERSUS RCT 2006;82: lack of widely available software; they are not yet found in the most common statistical packages, but that limitation is beginning to be overcome. References 1. Starr A, Edwards ML. Mitral replacement: clinical experience with a ball-valve prosthesis. Ann Surg 1961;154: Gao G, Wu Y, Grunkemeier GL, Furnary AP, Starr A. Forty-year survival with the Starr-Edwards heart valve prosthesis. J Heart Valve Dis 2004;13: Concato J. Prostate specific antigen: a useful screening test? Cancer J 2000;6(Suppl): Edmunds LH Jr, Clark RE, Cohn LH, Grunkemeier GL, and mortality after cardiac valvular operations. Ad Hoc Liaison Committee for standardizing definitions of prosthetic heart valve morbidity of the American Association for Thoracic Surgery and The Society of Thoracic Surgeons. J Thorac Cardiovasc Surg 1996;112: Edmunds LH Jr, Clark RE, Cohn LH, Grunkemeier GL, and mortality after cardiac valvular operations. The American Association for Thoracic Surgery, Ad Hoc Liason Committee for standardizing definitions of prosthetic heart valve morbidity. Ann Thorac Surg 1996;62: Edmunds LH Jr, Clark RE, Cohn LH, Grunkemeier GL, and mortality after cardiac valvular operations. Eur J Cardiothorac Surg 1996;10: Edmunds LH Jr, Clark RE, Cohn LH, Grunkemeier GL, and mortality after cardiac valvular operations. Asian Cardiovasc Thorac Ann 1996;4: Grunkemeier GL, Li HH, Naftel DC, Starr A, Rahimtoola SH. Long-term performance of heart valve prostheses. Curr Probl Cardiol 2000;25: Division of Cardiovascular and Neurological Devices. Draft Replacement Heart Valve Guidance, Version 4.1. Washington, DC: Center for Devices and Radiological Health, Food and Drug Administration; 1994: Johnson DM, Sapirstein W. FDA s requirements for in-vivo performance data for prosthetic heart valves. J Heart Valve Dis 1994;3: Sapirstein W. Designing trials for testing prosthetic cardiac valves: a Food and Drug Administration perspective. Am Heart J 2001;141: Bland JM, Altman DG. Bayesians and frequentists. Br Med J 1998;317: Oxenham H, Bloomfield P, Wheatley DJ, et al. Twenty year comparison of a Bjork-Shiley mechanical heart valve with porcine bioprostheses. Heart 2003;89: Hammermeister K, Sethi GK, Henderson WG, Grover FL, Oprian C, Rahimtoola SH. Outcomes 15 years after valve replacement with a mechanical versus a bioprosthetic valve: final report of the Veterans Affairs randomized trial. J Am Coll Cardiol 2000;36: Murday AJ, Hochstitzky A, Mansfield J, et al. A prospective controlled trial of St. Jude versus Starr Edwards aortic and mitral valve prostheses. Ann Thorac Surg 2003;76: Schaff H, Carrel T, Steckelberg JM, Grunkemeier GL, Holubkov R. Artificial Valve Endocarditis Reduction Trial (AVERT): protocol of a multicenter randomized trial. J Heart Valve Dis 1999;8: Schaff HV, Carrel TP, Jamieson WR, et al. Paravalvular leak and other events in Silzone-coated mechanical heart valves: a report from AVERT. Ann Thorac Surg 2002;73: Grunkemeier GL, Jin R, Im K, Holubkov R, Kennard ED, Schaff HV. Time-related risk of the St. Jude Silzone heart valve. Eur J Cardiothorac Surg 2006;30: Concato J. Observational versus experimental studies: what s the evidence for a hierarchy? NeuroRx 2004;1: Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med 2000;342: Grunkemeier GL, Starr A. Alternatives to randomization in surgical studies. J Heart Valve Dis 1992;1: Bach DS. Choice of prosthetic heart valves: update for the next generation. J Am Coll Cardiol 2003;42: Wheatley DJ. Clinical evaluation: statistical considerations and how to meet them in clinical practice. J Heart Valve Dis 2004;13(Suppl 1): Grapow MT, von Wattenwyl R, Guller U, Beyersdorf F, Zerkowski HR. Randomized controlled trials do not reflect reality: real-world analyses are critical for treatment guidelines. J Thorac Cardiovasc Surg 2006;132: Grunkemeier GL, Payne N. Bayesian analysis: a new statistical paradigm for new technology. Ann Thorac Surg 2002; 74: O Malley AJ, Normand SL, Kuntz RE. Application of models for multivariate mixed outcomes to medical device trials: coronary artery stenting. Stat Med 2003;22: Temple R. How FDA currently makes decisions on clinical studies. Clin Trials 2005;2: Campbell G. The experience in the FDA s Center for Devices and Radiological Health with Bayesian strategies. Clin Trials 2005;2: Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials Draft Guidance for Industry and FDA Staff, Available at: guidance/1601.html (accessed Aug 2, 2006). 30. Gill CJ, Sabin L, Schmid CH. Why clinicians are natural Bayesians. Br Med J 2005;330:
Surgery for Acquired Cardiovascular Disease
Performance of bioprostheses and mechanical prostheses assessed by composites of valve-related complications to 15 years after mitral valve replacement W. R. E. Jamieson, MD, O. von Lipinski, MD, R. T.
More informationW e have previously reported the results of a randomised
715 CARDIOVASCULAR MEDICINE Twenty year comparison of a mechanical heart valve with porcine bioprostheses H Oxenham, P Bloomfield, D J Wheatley, R J Lee, J Cunningham, R J Prescott, H C Miller... See end
More informationOn October 3, 1977, the first St. Jude Medical (SJM)
The St. Jude Medical Cardiac Valve Prosthesis: A 25-Year Experience With Single Valve Replacement Robert W. Emery, MD, Christopher C. Krogh, Kit V. Arom, MD, PhD, Ann M. Emery, RN, Kathy Benyo-Albrecht,
More information2017 Cardiovascular Symposium CARDIAC SURGERY UPDATE: SMALLER INCISIONS AND LESS COUMADIN DAVID L. SAINT, MD
2017 Cardiovascular Symposium CARDIAC SURGERY UPDATE: SMALLER INCISIONS AND LESS COUMADIN DAVID L. SAINT, MD David L Saint M.D. Tallahassee Memorial Hospital Southern Medical Group Division of Cardiothoracic
More informationRESEARCH AND REVIEWS: JOURNAL OF PHARMACOLOGY AND TOXICOLOGICAL STUDIES
e-issn:2322-0139 RESEARCH AND REVIEWS: JOURNAL OF PHARMACOLOGY AND TOXICOLOGICAL STUDIES Comparative Evaluation of Safety Outcomes of Different Prosthetic Valves in Indian Subjects. Kama Raval 1 *, Reena
More informationVery Long-Term Survival Implications of Heart Valve Replacement With Tissue Versus Mechanical Prostheses in Adults <60 Years of Age
Very Long-Term Survival Implications of Heart Valve Replacement With Versus Prostheses in Adults
More information15-Year Comparison of Supra-Annular Porcine and PERIMOUNT Aortic Bioprostheses
ORIGINAL CONTRIBUTION 15-Year Comparison of Supra-Annular Porcine and PERIMOUNT Aortic Bioprostheses WR Eric Jamieson, MD, Eva Germann, MSc, Michel R Aupart, MD 1, Paul H Neville, MD 1, Michel A Marchand,
More informationPrognosis after aortic valve replacement with St. Jude Medical bileaflet prostheses: impact on outcome of varying thromboembolic and bleeding hazards
European Heart Journal Supplements (1) 3 (Supplement Q), Q27 Q32 Prognosis after aortic valve replacement with St. Jude Medical bileaflet prostheses: impact on outcome of varying thromboembolic and bleeding
More informationReoperation for Bioprosthetic Mitral Structural Failure: Risk Assessment
Reoperation for Bioprosthetic Mitral Structural Failure: Risk Assessment W.R.E. Jamieson, MD; L.H. Burr, MD; R.T. Miyagishima, MD; M.T. Janusz, MD; G.J. Fradet, MD; S.V. Lichtenstein, MD; H. Ling, MD Background
More informationIntensity of oral anticoagulation after implantation of St. Jude Medical mitral or multiple valve replacement: lessons learned from GELIA (GELIA 5)
European Heart Journal Supplements () 3 (Supplement Q), Q39 Q43 Intensity of oral anticoagulation after implantation of St. Jude Medical mitral or multiple valve replacement: lessons learned from GELIA
More informationMedtronic Mosaic porcine bioprosthesis: Assessment of 12-year performance
Medtronic Mosaic porcine bioprosthesis: Assessment of 12-year performance W. R. Eric Jamieson, MD, a Friedrich-Christian Riess, MD, b Peter J. Raudkivi, MD, c Jacques Metras, MD, d Edward F. G. Busse,
More information16 YEAR RESULTS Carpentier-Edwards PERIMOUNT Mitral Pericardial Bioprosthesis, Model 6900
CLINICAL COMMUNIQUé 6 YEAR RESULTS Carpentier-Edwards PERIMOUNT Mitral Pericardial Bioprosthesis, Model 69 The Carpentier-Edwards PERIMOUNT Mitral Pericardial Valve, Model 69, was introduced into clinical
More informationA 20-year experience of 1712 patients with the Biocor porcine bioprosthesis
Acquired Cardiovascular Disease Mykén and Bech-Hansen A 2-year experience of 1712 patients with the Biocor porcine bioprosthesis Pia S. U. Mykén, MD, PhD, a and Odd Bech-Hansen, MD, PhD b Objective: The
More informationThe CarboMedics bileaflet prosthetic heart was introduced
The CarboMedics Valve: Experience With 1,049 Implants José M. Bernal, MD, José M. Rabasa, MD, Francisco Gutierrez-Garcia, MD, Carlos Morales, MD, J. Francisco Nistal, MD, and José M. Revuelta, MD Department
More informationUpdate on Oral Anticoagulation for Mechanical Heart Valves
Update on Oral Anticoagulation for Mechanical Heart Valves Douglas C. Anderson, Pharm.D., D.Ph. Professor and Chair Dept. of Pharmacy Practice Cedarville University School of Pharmacy OHIO SOCIETY OF HEALTH-SYSTEM
More informationP have been used for mitral and aortic valve replacement
A -Year Comparison of Mitral Valve Replacement With Carpentier-Edwards and Hancock Porcine Bioprostheses P. Perier, MD, A. Deloche, MD, S. Chauvaud, MD, J. C. Chachques, MD, J. Relland, MD, J. N. Fabiani,
More informationDurability of Pericardial Versus Porcine Aortic Valves
Journal of the American College of Cardiology Vol. 44, No. 2, 2004 2004 by the American College of Cardiology Foundation ISSN 0735-1097/04/$30.00 Published by Elsevier Inc. doi:10.1016/j.jacc.2004.01.053
More informationNineteen-Millimeter Aortic St. Jude Medical Heart Valve Prosthesis: Up to Sixteen Years Follow-up
Nineteen-Millimeter Aortic St. Jude Medical Heart Valve Prosthesis: Up to Sixteen Years Follow-up Dilip Sawant, FRCS, Arun K. Singh, MD, William C. Feng, MD, Arthur A. Bert, MD, and Fred Rotenberg, MD
More informationCarpentier-Edwards Pericardial Valve in the Aortic Position: 25-Years Experience
SURGERY: The Annals of Thoracic Surgery CME Program is located online at http://www.annalsthoracicsurgery.org/cme/ home. To take the CME activity related to this article, you must have either an STS member
More informationTAVR for Valve-In-Valve. Brian O Neill Assistant Professor of Medicine Department of Medicine, Section of Cardiology
TAVR for Valve-In-Valve Brian O Neill Assistant Professor of Medicine Department of Medicine, Section of Cardiology Temple Hearth and Vascular Institute Disclosures: Consultant: Cardiac Assist TAVR for
More informationMitral valve replacement in patients under 65 years of age: mechanical or biological valves?
REVIEW C URRENT OPINION Mitral valve replacement in patients under 65 years of age: mechanical or biological valves? David C. Reineke, Paul Philipp Heinisch, Bernhard Winkler, Lars Englberger, and Thierry
More informationTissue vs Mechanical What s the Data??
Biological (Tissue) Valve in a 60 year old patient: Debate Tissue vs Mechanical What s the Data?? Joseph E. Bavaria, MD Immediate-Past President - Society of Thoracic Surgeons (STS) Brooke Roberts-William
More informationCLINICAL COMMUNIQUE 16 YEAR RESULTS
CLINICAL COMMUNIQUE 6 YEAR RESULTS Carpentier-Edwards PERIMOUNT Mitral Pericardial Bioprosthesis, Model 6900 Introduction The Carpentier-Edwards PERIMOUNT Mitral Pericardial Valve, Model 6900, was introduced
More informationBiological or mechanical valve prosthesis?
XXIX Giornate Cardiologiche Torinesi ADVANCES IN CARDIAC ARRHYTHMIAS AND GREAT INNOVATIONS IN CARDIOLOGY Turin, October 27-28, 2017 Centro Congressi Unione Industriale WHAT HAS CHANGED IN CARDIAC SURGERY?
More informationLong-term Experience with the Bjork-Shiley Monostrut Tilting Disc Valve
J Korean Med Sci 2007; 22: 1060-4 ISSN 1011-8934 DOI: 10.3346/jkms.2007.22.6.1060 Copyright The Korean Academy of Medical Sciences Long-term Experience with the Bjork-Shiley Monostrut Tilting Disc Valve
More informationThe article by Stamou and colleagues [1] found that
THE STATISTICIAN S PAGE Propensity Score Analysis of Stroke After Off-Pump Coronary Artery Bypass Grafting Gary L. Grunkemeier, PhD, Nicola Payne, MPhiL, Ruyun Jin, MD, and John R. Handy, Jr, MD Providence
More informationEchocardiographic Evaluation of Mitral Valve Prostheses
Echocardiographic Evaluation of Mitral Valve Prostheses Dennis A. Tighe, M.D., FACC, FACP, FASE Cardiovascular Medicine University of Massachusetts Medical School Worcester, MA www.asecho.org 1 Nishimura
More informationSpotlight on valvular heart disease guidelines. Prosthetic heart valves. Bernard Iung Bichat Hospital, Paris Diderot University Paris, France
Spotlight on valvular heart disease guidelines. Prosthetic heart valves. Bernard Iung Bichat Hospital, Paris Diderot University Paris, France Faculty disclosure First name - last name I disclose the following
More informationTwenty-year experience with the St Jude Medical mechanical valve prosthesis
Surgery for Acquired Cardiovascular Disease Ikonomidis et al Twenty-year experience with the St Jude Medical mechanical valve prosthesis John S. Ikonomidis, MD, PhD John M. Kratz, MD Arthur J. Crumbley
More informationMitroflow Synergy Prostheses for Aortic Valve Replacement: 19 Years Experience With 1,516 Patients
Mitroflow Synergy Prostheses for Aortic Valve Replacement: 19 Years Experience With 1,516 Patients Kazutomo Minami, MD, Armin Zittermann, PhD, Sebastian Schulte-Eistrup, MD, Heinrich Koertke, MD, and Reiner
More informationMitral Valve Surgery: Lessons from New York State
Mitral Valve Surgery: Lessons from New York State Joanna Chikwe, MD Professor of Cardiovascular Surgery Icahn School of Medicine at Mount Sinai Chairman & Program Director Department of Cardiovascular
More informationBioprostheses are prone to continuous degeneration
Twenty-Year Experience With the St. Jude Medical Biocor Bioprosthesis in the Aortic Position Walter B. Eichinger, MD, Ina M. Hettich, MD, Daniel J. Ruzicka, MD, Klaus Holper, MD, Carolin Schricker, Sabine
More informationDepartment of Cardiothoracic Surgery, Heart and Lung Center, Lund University Hospital, Lund, Sweden
Long-Term Outcome of the Mitroflow Pericardial Bioprosthesis in the Elderly after Aortic Valve Replacement Johan Sjögren, Tomas Gudbjartsson, Lars I. Thulin Department of Cardiothoracic Surgery, Heart
More informationClinical event rates with the On-X bileaflet mechanical heart valve: A multicenter experience with follow-up to 12 years
Clinical event rates with the On-X bileaflet mechanical heart valve: A multicenter experience with follow-up to 12 years John B. Chambers, MD, FRCP, FACC, a Jose L. Pomar, MD, PhD, FETCS, b Carlos A. Mestres,
More informationMechanical vs. Bioprosthetic Aortic Valve Replacement: Time to Reconsider? Christian Shults, MD Cardiac Surgeon, Medstar Heart and Vascular Institute
Mechanical vs. Bioprosthetic Aortic Valve Replacement: Time to Reconsider? Christian Shults, MD Cardiac Surgeon, Medstar Heart and Vascular Institute Assistant Professor, Georgetown School of Medicine
More informationON-X and St.Jude Medical mechanical prosthesis. A paradox concept: they are equal but different
Accepted Manuscript ON-X and St.Jude Medical mechanical prosthesis. A paradox concept: they are equal but different Francesco Formica, MD, Stefano D Alessandro, MD, FECTS, Umberto Benedetto PII: S0022-5223(19)30709-3
More informationChoice of Prosthetic Heart Valve in Adults
Journal of the American College of Cardiology Vol. 55, No. 22, 2010 2010 by the American College of Cardiology Foundation ISSN 0735-1097/$36.00 Published by Elsevier Inc. doi:10.1016/j.jacc.2009.10.085
More informationPROVEN PLUS. Introducing the Avalus Aortic Valve by Medtronic.
PROVEN PLUS. Introducing the Avalus Aortic Valve by Medtronic. With more than 40 years of heart valve innovations, we took proven valve design concepts and adapted them for excellent implantability for
More informationThe advantages and disadvantages of mechanical valve prostheses and
Surgery for Acquired Cardiovascular Disease Comparison of survival after mitral valve replacement with biologic and mechanical valves in 1139 patients Ye-Ying Cen, MA Donald D. Glower, MD Kevin Landolfo,
More informationStandarized definition of bioprosthetic valve deterioration and failure
Translational aortic valve research. From biology to treatment Standarized definition of bioprosthetic valve deterioration and failure Anna Sonia Petronio, MD, FESC Head of Cardiac Catheterization Lab
More informationLONG-TERM OUTCOME AFTER BIOLOGIC VERSUS MECHANICAL AORTIC VALVE REPLACEMENT IN 841 PATIENTS
LONG-TERM OUTCOME AFTER BIOLOGIC VERSUS MECHANICAL AORTIC VALVE REPLACEMENT IN 841 PATIENTS David S. Peterseim, MD Ye-Ying Cen, MA Srinivas Cheruvu, MHS Kevin Landolfo, MD Thomas M. Bashore, MD James E.
More informationReaders of this journal are aware of the importance of. Bayesian Analysis: A New Statistical Paradigm for New Technology
THE STATISTICIAN S PAGE Bayesian Analysis: A New Statistical Paradigm for New Technology Gary L. Grunkemeier, PhD, and Nicola Payne, MPhil Providence Health System, Portland, Oregon Full Bayesian analysis
More informationChoice of Prosthetic Heart Valve for Adult Patients
Journal of the American College of Cardiology Vol. 41, No. 6, 2003 2003 by the American College of Cardiology Foundation ISSN 0735-1097/03/$30.00 Published by Elsevier Science Inc. doi:10.1016/s0735-1097(02)02965-0
More informationEVERYTHING ABOUT MECHANICAL VALVES HAS CHANGED
EVERYTHING ABOUT MECHANICAL VALVES HAS CHANGED 106180.001 CryoLife - New Brochure FIN.indd 1 06/10/2016 14:08 Why use another mechanical valve when 1 2 3 No other mechanical valve has: 1 90 leaflets: 1
More informationIn , three studies described patients
Heart 2001;85:337 341 VALVE DISEASE Should patients with asymptomatic mild or moderate aortic stenosis undergoing coronary artery bypass surgery also have valve replacement for their aortic stenosis? Shahbudin
More informationInterventional procedures guidance Published: 26 September 2014 nice.org.uk/guidance/ipg504
Transcatheter valve-in-valve e implantation for aortic bioprosthetic valve dysfunction Interventional procedures guidance Published: 26 September 2014 nice.org.uk/guidance/ipg504 Your responsibility This
More informationEcho Evaluation of a Mitral Valve Prostheses Sunday, February 14, :50 2:10 PM 20 min
2016 ASE State of the Art Echocardiography Course Tucson, AZ Echo Evaluation of a Mitral Valve Prostheses Sunday, February 14, 2016 1:50 2:10 PM 20 min 1 M U H A M E D S A R I Ć, M D, P H D D i r e c t
More informationTAVI- Is Stroke Risk the Achilles Heel of Percutaneous Aortic Valve Repair?
TAVI- Is Stroke Risk the Achilles Heel of Percutaneous Aortic Valve Repair? Elaine E. Tseng, MD and Marlene Grenon, MD Department of Surgery Divisions of Adult Cardiothoracic and Vascular and Endovascular
More information164 Ann Thorac Surg 45: , Feb Copyright by The Society of Thoracic Surgeons
Heart Valve Replacement with the Bjork-Shiley Mbnostrut Valve: Early Results of a Multicenter Clinical Investigation Lars I. Thulin, M.D., William H. Bain, F.R.C.S., Hans H. Huysmans, M.D., Gerrit van
More informationValve Disease in Patients With Heart Failure TAVI or Surgery? Miguel Sousa Uva Hospital Cruz Vermelha Lisbon, Portugal
Valve Disease in Patients With Heart Failure TAVI or Surgery? Miguel Sousa Uva Hospital Cruz Vermelha Lisbon, Portugal I have nothing to disclose. Wide Spectrum Stable vs Decompensated NYHA II IV? Ejection
More informationUNDERSTANDING YOUR HEART VALVE. Mosaic Tissue Valve
UNDERSTANDING YOUR HEART VALVE Mosaic Tissue Valve A Message to You from the Employees at Medtronic, Inc. We understand that having heart valve replacement surgery is an important change in your life.
More informationIndication, Timing, Assessment and Update on TAVI
Indication, Timing, Assessment and Update on TAVI Swedish Heart and Vascular Institute Ming Zhang MD PhD Interventional Cardiology Structure Heart Disease Conflict of Interest None Starr- Edwards Mechanical
More informationNearly 40 years after the pioneering efforts of Starr and
Prognosis After Aortic Valve Replacement With a Bioprosthesis Predictions Based on Meta-Analysis and Microsimulation J.P.A. Puvimanasinghe, MBBS, MSc, MD; E.W. Steyerberg, PhD; J.J.M. Takkenberg, MD; M.J.C.
More informationPrimary Tissue Valve Degeneration in Glutaraldehvde-Preserved Porcine Biomostheses: Hancock I Vekus Carpentier-Edwards at 4- to 7-Years Follow-up
Primary Tissue Valve Degeneration in Glutaraldehvde-Preserved Porcine Biomostheses: A Hancock I Vekus Edwards at 4- to 7-Years Follow-up Francisco Nistal, M.D., Edurne Artifiano, M.D., and Ignacio Gallo,
More informationDoes Patient-Prosthesis Mismatch Affect Long-term Results after Mitral Valve Replacement?
Original Article Does Patient-Prosthesis Mismatch Affect Long-term Results after Mitral Valve Replacement? Hiroaki Sakamoto, MD, PhD, and Yasunori Watanabe, MD, PhD Background: Recently, some articles
More informationIncidence of prosthesis-patient mismatch in patients receiving mitral Biocor porcine prosthetic valves
INTERVENTION/VALVULAR HEART DISEASE ORIGINAL ARTICLE Cardiology Journal 2016, Vol. 23, No. 2, 178 183 DOI: 10.5603/CJ.a2016.0011 Copyright 2016 Via Medica ISSN 1897 5593 Incidence of prosthesis-patient
More informationHeart valve replacement with the Bjork-Shiley and St Jude Medical prostheses: A randomized comparison in 178 patients
European Heart Journal (1990) 11, 583-591 Heart valve replacement with the Bjork-Shiley and St Jude Medical prostheses: A randomized comparison in 178 patients S. VOGT, A. HOFFMANN, J. ROTH, P. DUBACH,
More informationThe St. Jude Medical Biocor Bioprosthesis
The St. Jude Medical Biocor Bioprosthesis Clinical Evidence of Long-term Durability Long-term Biocor Experience A Review and Comparative Assessment Long-term Biocor Stented Tissue Valve Studies Twenty-year
More informationA valve was initiated at the Medical University of
St. Jude Prosthesis for Aortic and Mitral Valve Replacement: A Ten-Year Experience John M. Kratz, MD, Fred A. Crawford, Jr, MD, Robert M. Sade, MD, Arthur J. Crumbley, MD, and Martha R. Stroud, MS Division
More information42yr Old Male with Severe AR Mild LV dysfunction s/p TOF -AV Replacement(tissue valve) or AoV plasty- Kyung-Hwan Kim
42yr Old Male with Severe AR Mild LV dysfunction s/p TOF -AV Replacement(tissue valve) or AoV plasty- Kyung-Hwan Kim Current Guideline for AR s/p TOF Surgery is reasonable in adults with prior repair of
More informationCHAPTER VI ESTIMATING EVENT-FREE LIFE EXPECTANCY AFTER AUTOGRAFT AORTIC ROOT REPLACEMENT IN ADULTS: APPLICATION OF META-ANALYSIS AND MICROSIMULATION
CHAPTER VI ESTIMATING EVENT-FREE LIFE EXPECTANCY AFTER AUTOGRAFT AORTIC ROOT REPLACEMENT IN ADULTS: APPLICATION OF META-ANALYSIS AND MICROSIMULATION Presented at the VIII International Symposium of Cardiac
More informationLONG-TERM RESULTS OF HEART VALVE REPLACEMENT WITH THE EDWARDS DUROMEDICS BILEAFLET PROSTHESIS: A PROSPECTIVE TEN-YEAR CLINICAL FOLLOW-UP
LONG-TERM RESULTS OF HEART VALVE REPLACEMENT WITH THE EDWARDS DUROMEDICS BILEAFLET PROSTHESIS: A PROSPECTIVE TEN-YEAR CLINICAL FOLLOW-UP Bruno K. Podesser, MD a Gudrun Khuenl-Brady, MD a Ernst Eigenbauer,
More informationCarpentier-Edwards supra-annular aortic porcine bioprosthesis: Clinical performance over 20 years
Surgery for Acquired Cardiovascular Disease Carpentier-Edwards supra-annular aortic porcine bioprosthesis: Clinical performance over 20 years W. R. Eric Jamieson, MD, Lawrence H. Burr, MD, Robert T. Miyagishima,
More informationORIGINAL PAPER. The long-term results and changing patterns of biological valves at the mitral position in contemporary practice in Japan
Nagoya J. Med. Sci. 78. 369 ~ 376, 2016 doi:10.18999/nagjms.78.4.369 ORIGINAL PAPER The long-term results and changing patterns of biological valves at the mitral position in contemporary practice in Japan
More informationClinical material and methods. Copyright by ICR Publishers 2003
Fourteen Years Experience with the CarboMedics Valve in Young Adults with Aortic Valve Disease Jan Aagaard 1, Jens Tingleff 2, Per V. Andersen 1, Christel N. Hansen 2 1 Department of Cardio-Thoracic and
More informationReoperations after primary aortic valve replacement
Third-Time Aortic Valve Replacement: Patient s and Operative Outcome Kasra Shaikhrezai, MD, MRCS, Giordano Tasca, MD, FETCS, Mohamed Amrani, PhD, FETCS, Gilles Dreyfus, MD, FETCS, and George Asimakopoulos,
More informationBall Valve (Smeloff-Cutter) Aortic Valve Replacement Without Anticoagulation
Ball Valve (Smeloff-Cutter) Aortic Valve Replacement Without Anticoagulation Begonia Gometza, MD, and Carlos M. G. Duran, MD, PhD Department of Cardiovascular Diseases, King Faisal Specialist Hospital
More informationTSDA Boot Camp September 13-16, Introduction to Aortic Valve Surgery. George L. Hicks, Jr., MD
TSDA Boot Camp September 13-16, 2018 Introduction to Aortic Valve Surgery George L. Hicks, Jr., MD Aortic Valve Pathology and Treatment Valvular Aortic Stenosis in Adults Average Course (Post mortem data)
More informationLong-Term Results With the Medtronic-Hall Valvular Prosthesis
Long-Term Results With the Medtronic-Hall Valvular Prosthesis Cary W. Akins, MD Cardiac Surgical Unit, Massachusetts General Hospital, Boston, Massachusetts Background. Although more than 170,000 Medtronic-
More informationTAVI SURVEY. Performed by the ESC Council for Cardiology Practice
TAVI SURVEY Performed by the ESC Council for Cardiology Practice BACKGROUND To evaluate the knowledge and the behaviour of a large community of cardiologists working in different settings, both in hospital
More informationT sors in the following aspects: the porcine aortic valve
Clinical and Hemodynamic Assessment of the Hancock I1 Bioprosthesis Tirone E. David, MD, Susan Armstrong, MSc, and Zhao Sun, MA Division of Cardiovascular Surgery, The Toronto Hospital and University of
More informationThe St. Jude Medical mechanical valve is a low-profile,
Twenty-Five Year Experience With the St. Jude Medical Mechanical Valve Prosthesis J. Matthew Toole, MD, Martha R. Stroud, MS, John M. Kratz, MD, Arthur J. Crumbley III, MD, Scott M. Bradley, MD, Fred A.
More informationEvidence-based operational and strategic behavior of
Closing the Loop: Optimizing Physicians Operational and Strategic Behavior Paul T. Sergeant, MD, PhD, and Eugene H. Blackstone, MD Katholieke Universiteit Leuven, Leuven, Belgium, and The Cleveland Clinic
More informationManagement of Anticoagulation during Device Implants; Coumadin to Novel Agents
Management of Anticoagulation during Device Implants; Coumadin to Novel Agents DR D Birnie Invited Faculty Core Curriculum Heart Rhythm Society May 8 th 2014 Disclosures Boehringer Ingleheim Research Support
More informationSmeloff-Cutter Prosthesis: 1- to 12-Year Follow-up David S. Starr, M.D., Gerald M. Lawrie, M.D., J. F. Howell, M.D., and George C. Morris, Jr., M.D.
Clinical Experience with the Smeloff-Cutter Prosthesis: 1- to 12-Year Follow-up David S. Starr, M.D., Gerald M. Lawrie, M.D., J. F. Howell, M.D., and George C. Morris, Jr., M.D. ABSTRACT To determine the
More informationRepeated mitral valve replacement in a patient with extensive annular calcification
CASE REPORT Open Access Repeated mitral valve replacement in a patient with extensive annular calcification Tadashi Kitamura 1,2*, Sachito Fukuda 1, Takahiro Sawada 1, Sumio Miura 1, Ikutaro Kigawa 1,3
More information40 Years Experience in Mitral Valve Replacement Using Starr-Edwards, St. Jude Medical and ATS Valves
Original Article 40 Experience in Mitral Valve Replacement Using Starr-Edwards, St. Jude Medical and ATS Valves Akira Sezai, MD, Motomi Shiono, MD, Mitsumasa Hata, MD, Mitsuru Iida, MD, Masataka Yoda,
More information1198 MINAKATA K et al. Circ J 2017; 81: ORIGINAL ARTICLE doi: /circj.CJ
1198 MINAKATA K et al. Circ J 2017; 81: 1198 1206 ORIGINAL ARTICLE doi: 10.1253/circj.CJ-17-0154 Valvular Heart Disease Comparison of the Long-Term Outcomes of Mechanical and Bioprosthetic Aortic Valves
More informationThe CarboMedics prosthetic valve (Sulzer CarboMedics,
Long-Term Result of 1144 CarboMedics Mechanical Valve Implantations Chang Hyun Kang, MD, Hyuk Ahn, MD, Kyung Hwan Kim, MD, and Ki-Bong Kim, MD Department of Thoracic and Cardiovascular Surgery, Seoul National
More informationThe operative mortality rate after redo valvular operations
Clinical Outcomes of Redo Valvular Operations: A 20-Year Experience Naoto Fukunaga, MD, Yukikatsu Okada, MD, Yasunobu Konishi, MD, Takashi Murashita, MD, Mitsuru Yuzaki, MD, Yu Shomura, MD, Hiroshi Fujiwara,
More informationSince Hufnagel and associates implanted a plastic ball
Evaluation of Valve Sound and Its Effects on ATS Prosthetic Valves in Patients Quality of Life Akira Sezai, MD, Motomi Shiono, MD, Yukihiko Orime, MD, Hiroaki Hata, MD, Shinya Yagi, MD, Nanao Negishi,
More informationThe Pendulum of Bridging Periprocedural Anticoagulant Therapy. Alan K. Jacobson, MD Cardiology Section Loma Linda VA Medical Center Loma Linda, CA
The Pendulum of Bridging Periprocedural Anticoagulant Therapy Alan K. Jacobson, MD Cardiology Section Loma Linda VA Medical Center Loma Linda, CA Disclosures Department of Veterans Affairs Industry Relationships:
More informationGuidance Document for Claims Based on Non-Inferiority Trials
Guidance Document for Claims Based on Non-Inferiority Trials February 2013 1 Non-Inferiority Trials Checklist Item No Checklist Item (clients can use this tool to help make decisions regarding use of non-inferiority
More informationACCP Cardiology PRN Journal Club
ACCP Cardiology PRN Journal Club 1 Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation and Valvular Heart Disease Cody A. Carson, PharmD, BCPS PGY2 Cardiology Pharmacy Resident
More informationStentless aortic valve replacement in the young patient: long-term results
Christ et al. Journal of Cardiothoracic Surgery 2013, 8:68 RESEARCH ARTICLE Open Access Stentless aortic valve replacement in the young patient: long-term results Torsten Christ *, Herko Grubitzsch, Benjamin
More informationHani K. Najm MD, Msc, FRCSC FACC, FESC President Saudi Society for Cardiac Surgeons Associate Professor of Cardiothoracic Surgery King Abdulaziz
Hani K. Najm MD, Msc, FRCSC FACC, FESC President Saudi Society for Cardiac Surgeons Associate Professor of Cardiothoracic Surgery King Abdulaziz Cardiac Centre Riyadh, Saudi Arabia Decision process for
More informationValve prosthesis-patient mismatch (PPM) was first defined
Impact of Valve Prosthesis-Patient Mismatch on Short-Term Mortality After Aortic Valve Replacement Claudia Blais, BSc; Jean G. Dumesnil, MD; Richard Baillot, MD; Serge Simard, MS; Daniel Doyle, MD; Philippe
More informationVALVE REPAIR VERSUS REPLACEMENT FOR MITRAL INSUFFICIENCY: WHEN IS A MECHANICAL VALVE STILL INDICATED?
VALVE REPAIR VERSUS REPLACEMENT FOR MITRAL INSUFFICIENCY: WHEN IS A MECHANICAL VALVE STILL INDICATED? Eugene A. Grossi, MD Aubrey C. Galloway, MD Jeffrey S. Miller, MD Greg H. Ribakove, MD Alfred T. Culliford,
More informationCoreValve in a Degenerative Surgical Valve
CoreValve in a Degenerative Surgical Valve Ran Kornowski, MD, FESC, FACC Chairman Department of Cardiology Rabin Medical Center, Petach Tikva, Israel Disclosure Statement of Financial Interest I, Ran Kornowski,
More informationInterventions in Congenital & Structural Heart Disease: Who Drives New Techniques and Devices?
Interventions in Congenital & Structural Heart Disease: Who Drives New Techniques and Devices? Lee Benson MD Professor Pediatrics (Cardiology) Director, Cardiac Diagnostic & Interventional Unit The Hospital
More informationResults of Transfemoral Transcatheter Aortic Valve Implantation
Results of Transfemoral Transcatheter Aortic Valve Implantation Saudi Heart Association, February 21-24 Rüdiger Lange, MD, PhD Nicolo Piazza, MD, FRCPC, FESC German Heart Center, Munich, Germany Division
More informationAssessment of Hemodynamics Properties of a New-Type Artificial Heart Valve Prosthesis Using Catheterization and Echocardiography
American Journal of Hematology 81:563 567 (2006) Assessment of Hemodynamics Properties of a New-Type Artificial Heart Valve Prosthesis Using Catheterization and Echocardiography Y.J. Zeng, 1,4 * S.W. Xu,
More informationIn Vitro Two-Dimensional Echocardiographic Imaging of a Stented Porcine Bioprosthetic Valve: The Bent Strut Artifact
C 2008, the Author Journal compilation C 2008, Wiley Periodicals, Inc. DOI: 10.1111/j.1540-8175.2008.00753.x In Vitro Two-Dimensional Echocardiographic Imaging of a Stented Porcine Bioprosthetic Valve:
More informationExtension to medium and low risk patients? Friedrich Eckstein University Hospital Basel
TAVI CON Extension to medium and low risk patients? Friedrich Eckstein University Hospital Basel Extension to medium and low risk patients? In octogenerians already reality in most of the swiss clinics!?
More informationThe PROACT Trial: valve choice has changed
The PROACT Trial: valve choice has changed Marc W. Gerdisch, MD On behalf of the PROACT Investigators; Chief Cardiovascular and Thoracic Surgery Co-director Franciscan Heart Valve Center Cardiac Surgery
More informationΧειρουργική Αντιμετώπιση της Ανεπάρκειας της Μιτροειδούς Βαλβίδας
Χειρουργική Αντιμετώπιση της Ανεπάρκειας της Μιτροειδούς Βαλβίδας Dr Χρήστος ΑΛΕΞΙΟΥ MD, PhD, FRCS(Glasgow), FRCS(CTh), CCST(UK) Consultant Cardiothoracic Surgeon Normal Mitral Valve Function Mitral Regurgitation
More informationHow to Avoid Prosthesis-Patient Mismatch
How to Avoid Prosthesis-Patient Mismatch Philippe Pibarot, DVM, PhD, FACC, FAHA, FASE, FESC Canada Research Chair in Valvular Heart Diseases INSTITUT UNIVERSITAIRE DE CARDIOLOGIE ET DE PNEUMOLOGIE DE QUÉBEC
More informationMethods: Between 1975 and 2003, 267 isolated mitral mechanical prostheses were implanted. Follow-up reached patient-years.
Mitral mechanical replacement in young rheumatic women: Analysis of long-term survival, valve-related complications, and pregnancy outcomes over a 3707 patient-year follow-up Luca Salvatore De Santo, MD,
More informationLate failure of transcatheter heart valves: An open question
Late failure of transcatheter heart valves: An open question A comparison with surgically implanted bioprosthetic heart valves. A. Rashid The Cardiothoracic Centre Liverpool, UK. Conflict of Interest Statement
More informationS ince the two large randomised trials of the 1970s
23 CARDIOVASCULAR MEDICINE Mid term outcome and quality of life after aortic valve replacement in elderly people: mechanical versus stentless biological valves I Florath, A Albert, U Rosendahl, T Alexander,
More information