Central MessageHemolysis assessed by forward and backward flow turbulence.See Article page 88 in the January 2020 issue. Hemolysis assessed by forward and backward flow turbulence. See Article page 88 in the January 2020 issue. Hatoum and colleagues1Hatoum H. Maureira P. Dasi L.P. A turbulence in vitro assessment of On-X and St Jude Medical prostheses.J Thorac Cardiovasc Surg. 2020; 159: 88-97Abstract Full Text Full Text PDF Scopus (15) Google Scholar seem to be struggling with the fact that forward flow turbulence, blood damage, and reduced anticoagulation are somewhat contradictory.1Hatoum H. Maureira P. Dasi L.P. A turbulence in vitro assessment of On-X and St Jude Medical prostheses.J Thorac Cardiovasc Surg. 2020; 159: 88-97Abstract Full Text Full Text PDF Scopus (15) Google Scholar This article, though, is not a revelation. In a particle image velocimetry dynamic study published by Akutsu and Matsumoto,2Akutsu T. Matsumoto A. Influence of three mechanical bileaflet prosthetic valve designs on the three-dimensional flow field inside a simulated aorta.J Artif Organs. 2010; 13: 207-217Crossref PubMed Scopus (14) Google Scholar the authors found higher Reynolds numbers in the On-X prosthesis (CryoLife Inc, Kennesaw, Ga) than the St Jude Medical (HP Masters series; St Paul, Minn) prosthesis. Hatoum and colleagues1Hatoum H. Maureira P. Dasi L.P. A turbulence in vitro assessment of On-X and St Jude Medical prostheses.J Thorac Cardiovasc Surg. 2020; 159: 88-97Abstract Full Text Full Text PDF Scopus (15) Google Scholar correctly point out that the bulk fluid dynamic properties of gradient and effective orifice area are not directly and always related to turbulence as measured by the Reynolds number. The mechanics of opening during the cardiac cycle and closing, as pointed out by Hatoum and colleagues,1Hatoum H. Maureira P. Dasi L.P. A turbulence in vitro assessment of On-X and St Jude Medical prostheses.J Thorac Cardiovasc Surg. 2020; 159: 88-97Abstract Full Text Full Text PDF Scopus (15) Google Scholar should be noted as influenced entirely by design. The On-X prosthesis design intends that the leaflets react to local fluid environment and do not become pinned against an artificial stop. The authors want to make the turbulence measures relate to hemolysis but provide no clinical evidence of this, only bench studies that look at shear-related hemolysis. This would make one suppose that the St Jude Medical prosthesis should have lower evidence of hemolysis than the On-X prosthesis. However, that is not the case and the opposite is actually true, as shown by several investigators in studies of multiple prostheses, namely Birnbaum and colleagues3Birnbaum D. Lackovics A. Heidt M. Oelert H. Laufer G. Greve H. et al.Examination of hemolytic potential with the On-X(R) prosthetic heart valve.J Heart Valve Dis. 2000; 9: 142-145PubMed Google Scholar and Skoularigis and colleagues.4Skoularigis J. Essop M.R. Skudicky D. Middlemost S.J. Sareli P. Frequency and severity of intravascular hemolysis after left-sided cardiac valve replacement with Medtronic Hall and St. Jude Medical prostheses, and influence of prosthetic type, position, size and number.Am J Cardiol. 1993; 71: 587-591Abstract Full Text PDF PubMed Scopus (87) Google Scholar The authors identify their problem, though, in that they did not examined backflow. Backflow is likely more important to hemolysis than forward flow due to the high shear in leakage jets. This thought is based on historical clinical observations of hemolysis. When first reported with ball-in-cage prostheses, which have no closed leakage, hemolysis (represented by serum lactic dehydrogenase) was observed at a higher rate in aortic prostheses than mitral prostheses, indicating that it was due to forward shear flow. However, this phenomenon shifted with the advent of the titling disc and then the bileaflet prostheses, all of which have designed and controlled closed leakage. Now hemolysis became more prevalent in mitral prostheses than in aortic prostheses. Forward flow gradients had been reduced to the point that there was much less production of blood damage. The gradients in backflow became much higher and the leakage jets became of high velocity and turbulent (causing much more damage in the mitral position due to the higher driving forces). Presently, blood damage is more a mitral problem than an aortic problem. Hinge flow is important throughout the cycle to avoid stasis in all locations and reduce fluid shear work to avoid both thrombus formation and blood damage. The On-X prosthesis in the aortic position has hemolysis measures in the normal range and approaching those of the tissue bioprostheses. The St Jude Medical prosthesis has higher hemolysis. This is why a single in vitro test is wholly inadequate to describe clinical performance. This article is interesting but not clinically informative. A turbulence in vitro assessment of On-X and St Jude Medical prosthesesThe Journal of Thoracic and Cardiovascular SurgeryVol. 159Issue 1PreviewThe objective of this study was to investigate and compare the hemodynamic and turbulence characteristics upon implantation of St Jude Medical (SJM) (St Jude Medical, St Paul, Minn) and On-X (On-X Life Technologies, Kennesaw, Ga) bileaflet mechanical valves. Both valves are considered highly successful bileaflet mechanical valves characterized by good clinical outcomes despite their numerous design differences. Although thromboembolism remains the main disadvantage of bileaflet mechanical valves, On-X valves have been shown to need less anticoagulation therapy. Full-Text PDF Open Archive

Objectives: The Prospective Randomized On-X Mechanical Prosthesis Versus St Jude Medical Mechanical Prosthesis Evaluation (PROSE) trial purpose was to investigate whether a current-generation mechanical prosthesis (On-X; On-X Life Technologies/Artivion Inc) reduced the incidence of thromboembolic-related complications compared with a previous-generation mechanical prosthesis (St Jude Medical Mechanical Prosthesis; Abbott/St Jude Medical). This second report documents the valve-related complications by individual prostheses and by Western and Developing populations. Methods: The PROSE trial study was conducted in 28 worldwide centers and incorporated 855 subjects randomized between 2003 and 2016. The study enrollment was discontinued on August 31, 2016. The study protocol, and analyses of 10 demographic variables and 24 risk factors were published in detail in 2021. Results: The total patient population (N = 855) included patients receiving an On-X valve (n = 462) and a St Jude Medical valve (n = 393). The overall freedom evaluation showed no differences at 5 years between the prostheses for thromboembolism or for valve thrombosis. There were also no differences in mortality. There were several differences between Developing and Western populations. The freedom relations at 5 years for mortality favored Western over Developing populations. Valve thrombosis was differentiated by position and site: aortic < mitral (P = .007) and Western < Developing (P = .005). In the mitral position there were no cases in Western populations, whereas there were 8 in Developing populations (P = .217). Conclusions: The On-X valve and St Jude Medical valve performed equally well in the study with no differences found. The only differentiation occurred with valve thrombosis in the mitral position more than the aortic position and occurring in Developing more than Western populations. The occurrence of valve thrombosis was also related to a younger population possibly due to anticoagulation compliance based on record review.

Sutureless aortic bioprostheses, represented by the Perceval bioprosthesis, has been the most recent advancement of aortic replacement prostheses to follow conventional bioprostheses and transarterial valve implantation (TAVI). The predominant consideration is to facilitate aortic replacement for severe symptomatic aortic stenosis that will serve the lifetime of the patient. In each case, the patient, surgeon, and cardiologist must choose between mechanical prostheses and the various formulations of bioprostheses.

Objectives The prosthesis type for multiple valve surgery (replacement of two or more diseased native or prosthetic valves, replacement of two diseased valves with repair/reconstruction of a third, or replacement of a single diseased valve with repair/reconstruction of a second valve) remains inadequately evaluated. The clinical performance of multiple valve surgery with bioprostheses (BP) and mechanical prostheses (MP) was assessed to compare patient survival and composites of valve-related complications. Methods Between 1975 and 2000, 1245 patients had multiple valve surgery (BP 785, mean age 62.0 ± 14.7 years; and MP 460, mean age 56.9 ± 12.9 years). There were 1712 procedures performed [BP 969(56.6%) and MP 743(43.4%). Concomitant coronary artery bypass (conCABG) was BP 206(21.3%) and MP 105(14.1%) (p = 0.0002). The cumulative follow-up was BP 5131 years and MP 3364 years. Independent predictors were determined for mortality, valve-related complications and composites of complications. Results Unadjusted patient survival at 12 years was BP 52.1 ± 2.1% and MP 54.8 ± 4.6% (p = 0.1127), while the age adjusted survival was BP 48.7 ± 2.3% and MP 54.4 ± 5.0%. The predictors of overall mortality were age [Hazard Ratio (HR) 1.051, p < 0.0001], previous valve (HR 1.366, p = 0.028) and conCABG (HR 1.27, p = 0.021). The actual freedom from valve-related mortality at 12 years was BP 85.6 ± 1.6% and MP 91.0 ± 1.6% (actuarial p = 0.0167). The predictors of valve-related mortality were valve type (BP > MP) (2.61, p = 0.001), age (HR 1.032, p = 0.0005) and previous valve (HR 12.61, p < 0.0001). The actual freedom from valve-related reoperation at 12 years was BP 60.8 ± 1.9% and MP85.6 ± 2.1% (actuarial p < 0.001). The predictors of valve-related reoperation were valve type (MP > BP) (HR 0.32, p < 0.0001), age (HR 0.99, p = 0.0001) and previous valve (HR 1.38, p = 0.008) Conclusions Overall survival (age adjusted) is differentiated by valve type over 10 and 12 years and valve-related mortality and valve-related reoperation favours the use of mechanical prostheses, overall for multiple valve surgery.

Objectives The PROSE trial purpose is to investigate whether the incidence of thromboembolic—related complications is reduced with a current generation mechanical prosthesis (On-X Life Technologies/CryoLife Inc.—On-X) compared with a previous generation mechanical prosthesis (St Jude Medical—SJM). The primary purpose of the initial report is to document the preoperative demographics, and the preoperative and operative risk factors by individual prosthesis and by Western and Developing populations. Methods The PROSE study was conducted in 28 worldwide centres and incorporated 855 subjects randomized between 2003 and 2016. The study enrollment was discontinued on August 31, 2016. The preoperative demographics incorporated age, gender, functional class, etiology, prosthetic degeneration, primary rhythm, primary valve lesion, weight, height, BSA and BMI. The preoperative and operative evaluation incorporated 24 risk factors. Results The total patient population (855) incorporated On-X population (462) and the St Jude Medical population (393). There was no significant difference of any of the preoperative demographics between the On-X and SJM groups. The preoperative and operative risk factors evaluation showed there was no significant difference between the On-X and St Jude Medical populations. The preoperative and operative risk factors by valve position (aortic and mitral) also documented no differentiation. The dominant preoperative demographics of the Western world population were older age, male gender, sinus rhythm, aortic stenosis, congenital aortic lesion, and mitral regurgitation. The dominant demographics of the Developing world population were rheumatic etiology, atrial fibrillation, aortic regurgitation, mixed aortic lesions, mitral stenosis and mixed mitral lesions. The Developing world group had only one significant risk factor, congestive heart failure. The majority of the preoperative and operative risk factors were significant in the Western world population. Conclusions The preoperative demographics do not differentiate the prostheses but do differentiate the Western and Developing world populations. The preoperative and operative risk factors do not differentiate the prostheses BUT do differentiate the Western and Developing world populations.

Central MessageThromboembolism with mechanical prostheses reduced with 6-month interval of learning anticoagulant management.See Article page 74. Thromboembolism with mechanical prostheses reduced with 6-month interval of learning anticoagulant management. See Article page 74. The major complications of mechanical heart valve prostheses are thromboembolism and bleeding. In this issue of The Journal of Thoracic and Cardiovascular Surgery, Havers-Borgersen and colleagues have strived to evaluate a method of reduction of major complications related to the use of vitamin K antagonists.1Havers-Borgersen E. Butt J.H. Vinding N.E. Torp-Pedersen C. Gislason G. Køber L. et al.Time in therapeutic range and risk of thromboembolism and bleeding in patients with a mechanical heart valve prosthesis.J Thorac Cardiovasc Surg. 2020; 159: 74-83.e4Abstract Full Text Full Text PDF Scopus (12) Google Scholar The major thromboembolic complications are prosthesis thrombosis, stroke, acute myocardial complication, and arterial embolism. The authors have advanced an evaluation of anticoagulant therapeutic range during the initial 6 months after surgery to achieve reduction of thromboembolism and bleeding complications. The authors assessed international normalized ratio evaluations in 659 patients during the 6-month index period after surgery. The patients who experienced thromboembolism, hemorrhage, and death during completion of the index period were excluded in the analysis. The time in therapeutic range (TTR) was determined in 2 groups: less than 70% and 70% or higher, determined according to international normalized ratio evaluations of 2-3 for aortic prostheses and 2.5-3.5 for mitral prostheses. The time in the therapeutic interval was determined with the total time of observation. The lower-quality TTR of less than 70% revealed a higher level of thromboembolism compared with the higher-quality TTR of 70% or higher. The baseline characteristics were similar within the 2 groups of time in the therapeutic ranges. The TTR was lower for the mechanical mitral prostheses than the mechanical aortic prostheses. The incidence of thromboembolism and all-cause mortality in the total mechanical heart valve population was greater in TTR of less than 70% compared with TTR of 70% or higher. The overall evaluation failed to reveal any difference in anticoagulant bleeding, defined by admission to hospitalization for bleeding complications. Mechanical prostheses are of major importance in patients younger than 65 years of age. It is very considerate to place bioprostheses in patients of more advanced age whose life expectancy is more in keeping with advanced failure of bioprostheses. Valve-in-valve procedures are commonly performed for structural valve deterioration of aortic bioprostheses, more adaptable to failed aortic bioprostheses than mitral bioprostheses. The potential of valve-in-valve procedures for structural valve deterioration can only provide satisfactory hemodynamics with consideration of satisfactory size of the initial bioprostheses. This study by Havers-Borgersen and colleagues is of extreme importance for the determination of control of thromboembolic complications of mechanical prostheses. The process of determining advanced therapeutic time range facilitates patients having a 6-month index period to learn the importance of proper anticoagulation management. The recommended anticoagulant levels used in this study are generally accepted levels for patient management of aortic and mitral mechanical prostheses. The 6-month index time interval to learn the advancement of anticoagulant management is the major critical recommendation of this study. The recommendation is that all patients having the importance of the determination of advancement of therapeutic time intervals is extremely important in the early anticoagulant management with mechanical prostheses implantations.

The effects of patient-prosthesis mismatch (PPM) after surgical aortic valve replacement (SAVR) suggest worse outcomes with smaller valves. We assessed clinical outcomes of younger females undergoing SAVR, using small and large prostheses, and the incremental risk of PPM. Between January 2002 and June 2015, 451 younger (age ≤65 years) female patients underwent SAVR. Patients were stratified into small prostheses (SP) ≤21 mm (n = 256) and large prostheses (LP) ≥23 mm (n = 195) groups. PPM was classified as moderate if indexed effective orifice area (iEOA) 0.65-0.85 cm2/m2, or severe if iEOA <0.65 cm2/m2. Operative mortality was not statistically different between SP and LP groups (2.4% vs 0.5%; P = 0.146). Unadjusted 10-year survival was 82% (95% confidence interval 77-87%), and was similar in both groups (P = 0.210). When grouped by standard PPM thresholds, only severe PPM was associated with significantly decreased survival (P = 0.007). A significant survival decrease was detected in LP group with iEOA ≤0.75 cm2/m2 (P < 0.001). Among SP patients, iEOA ≤0.65 cm2/m2 was associated with increased mortality (P = 0.075). After adjusting for potential confounders, Cox proportional hazard model identified iEOAs of ≤0.65 cm2/m2 (hazard ratio 1.85; P = 0.066) and ≤0.75 cm2/m2 (hazard ratio 2.3; P ≤ 0.003) as predictors of decreased long-term survival, in SP and LP groups, respectively. Among younger females who underwent SAVR, postoperative complications and in-hospital outcomes were substantially similar between the SP and LP groups. However, patients who received LP were adversely affected at lesser degrees of PPM than those who received SP. While SP patients may tolerate until iEOA ≤0.65 cm2/m2, our results suggest that moderate PPM of iEOA ≤0.75 for LP patients should be avoided.

BACKGROUND The burden oral anticoagulation is a limitation of mechanical valve prostheses. OBJECTIVES The aim of this study was to test whether patients could be safely managed with dual-antiplatelet therapy (DAPT) (aspirin 325 mg and clopidogrel 75 mg) or lower warfarin after On-X mechanical aortic valve replacement (mAVR). METHODS PROACT (Prospective Randomized On-X Anticoagulation Trial) (n = 576) is a multicenter (41 sites) noninferiority trial. From June 2006 through February 2014, 201 patients >= 18 years of age without thromboembolic risk factors undergoing mAVR were randomized to receive DAPT (n = 99) or standard warfarin plus aspirin (n = 102) 3 months after mAVR (low-risk arm). From June 2006 through October 2009, 375 patients with 1 or more thromboembolic risk factors were also randomized to lower intensity warfarin plus aspirin (international normalized ratio 1.5 to 2.0; n = 185) or standard warfarin plus aspirin (international normalized ratio 2.0 to 3.0; n = 190) 3 months after mAVR (high-risk arm). RESULTS The low-risk arm was terminated for excess cerebral thromboembolic events (3.12% per patient-year vs. 0.29% per patient-year, p = 0.02) in the DAPT group at up to 8.8-year follow-up (631.6 patient-years), with no differences in bleeding or all-cause mortality. High-risk arm patients experienced significantly lower major (1.59% per patient-year vs. 3.94% per patient-year, p = 0.002) and minor (1.27% per patient-year vs. 3.49% per patient-year, p = 0.002) bleeding up to 8.7-year follow-up (2,035.2 patient-years), with no differences in thromboembolism (0.42% per patient-year vs. 0.09% per patient-year, p = 0.20) and all-cause mortality. CONCLUSIONS DAPT was associated with higher rates of thromboembolism and valve thrombosis compared with control in the low-risk arm. International normalized ratios were safely maintained at 1.5 to 2.0 in high-risk patients, without differences in mortality or thromboembolic complications. (C) 2018 Published by Elsevier on behalf of the American College of Cardiology Foundation.

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Summary This chapter discusses the role and performance of aortic valve procedures for management of aortic stenosis. The indications and outcomes of surgical aortic valve replacement and transcatheter aortic valve implantation are reviewed. The prosthesis type for aortic stenosis procedures is predominantly bioprostheses and the results and complications of bioprostheses are reviewed. Finally, the recommended follow-up protocol for patients with valvular replacement or reconstruction is presented.

See related article on pages 1567-75. See related article on pages 1567-75. The article in this issue of the Journal entitled “Early Hemodynamic Performance of the Third Generation St Jude Medical Trifecta Aortic Prosthesis” by Phan and colleagues1Phan K. Ha H. Phan S. Misfeld M. Di Eusanio M. Yan T. Early hemodynamic performance of the third generation St Jude Trifecta aortic prosthesis: A systematic review and meta-analysis.J Thorac Cardiovasc Surg. 2015; 149: 1567-1575.e2Abstract Full Text Full Text PDF Scopus (23) Google Scholar is an evaluation of safety and hemodynamic performance of the Trifecta aortic prosthesis (St Jude Medical, Inc, St Paul, Minn) in the short term in a meta-analysis of 2549 patients from 13 studies. Phan and colleagues1Phan K. Ha H. Phan S. Misfeld M. Di Eusanio M. Yan T. Early hemodynamic performance of the third generation St Jude Trifecta aortic prosthesis: A systematic review and meta-analysis.J Thorac Cardiovasc Surg. 2015; 149: 1567-1575.e2Abstract Full Text Full Text PDF Scopus (23) Google Scholar report acceptable mean gradients and effective orifice areas in all prostheses from 19 to 29 mm. The St Jude Medical Trifecta was evaluated in a multicenter investigational trial conducted in North America and Europe between 2009 and 2011 and subsequently approved by the US Food and Drug Administration. The analysis by Phan and colleagues1Phan K. Ha H. Phan S. Misfeld M. Di Eusanio M. Yan T. Early hemodynamic performance of the third generation St Jude Trifecta aortic prosthesis: A systematic review and meta-analysis.J Thorac Cardiovasc Surg. 2015; 149: 1567-1575.e2Abstract Full Text Full Text PDF Scopus (23) Google Scholar incorporates studies published primarily in 2013 and 2014 and formulated to evaluate the safety and hemodynamic performance in this most recent new aortic bioprosthesis. At the request of the peer reviewers, the article incorporates an introduction to important considerations for implantation. The design of the prosthesis and the implantation characteristics can both contribute to altered hemodynamic performance of this uniquely designed bioprosthesis. The Trifecta bioprosthesis is designed for supra-annular implantation, with specific design characteristics intended to advance durability but contribute to important characteristics for implantation. The Trifecta is a trileaflet pericardial prosthesis formulated with a titanium stent. The titanium stent is covered with a polyester fabric, which is subsequently covered with porcine pericardial tissue. The prosthesis leaflets are fabricated bovine pericardium mounted externally. The porcine covers on the polyester stent and the bovine pericardial leaflets protect from mechanical wear by allowing only tissue-tissue contact. The porcine and bovine pericardium are preserved and cross-linked with glutaraldehyde and treated with the ethanol LINX anticalcification technology (St Jude Medical). The Trifecta prosthesis is a high-profile valve, and this in combination with the titanium stent can contribute to deformation of the prosthesis at surgical implantation. The valve size selection must be based on the recipient annulus and anatomy of the sinotubular junction. There are several important factors that must be given attention in both selection of the prosthesis size and implantation. Deformation of the titanium stent must be absolutely avoided at prosthesis implantation, because any stent deformation will be permanent and obviously contribute to altered permanent hemodynamics. The sizing of the prosthesis can facilitate this important factor. The sizer for the prosthesis is a double-ended device to size the annulus with a cylinder and a replica of the prosthesis for supra-annular placement. Oversizing of the prosthesis can also be a factor in prosthesis deformation at implantation. The cylinder of the sizer must only pass through the annulus with moderate resistance, and the flanged portion of the sizer, representing the supra-annular prosthesis, must never be passed through the annulus. The Trifecta prosthesis must never be oversized, because titanium deformation can be caused by oversizing. If there is any choice between 2 sizes, the smaller of size must be chosen to avoid oversizing and potential prosthesis deformation. The replica sizer will also provide any potential risk of coronary obstruction, because the stent posts must avoid obstruction to the coronary ostia. In summary, oversizing and deformation of the high-profile stents at implantation are extremely important to avoid deformation of the titanium stent, which will cause permanent implantation characteristics that in turn can cause reduced hemodynamic performance and potentially regurgitation of improperly approximating cusps. The article documents that 60.3% of the prostheses are sizes 19 and 21 mm, whereas only 25.1% are size 23 mm. The documented prosthesis sizes had to be implanted with the documented considerations addressed in this commentary regarding the Trifecta prosthesis. It is of extreme importance to note that the hemodynamics remained excellent for all sizes, with a pooled mean gradient of 9.2 mm Hg and an effective orifice area of 1.8 cm2. The St Jude Medical Trifecta pericardial prosthesis must never be oversized, and at implantation the stent post positioning must not be altered, because any altered positioning will result in titanium stent deformation and the potential for altered hemodynamics and bovine pericardial leaflet positioning. The article does indeed document the safety of the prosthesis and excellent hemodynamics of the prosthesis, even for sizes 19 and 21 mm. Early hemodynamic performance of the third generation St Jude Trifecta aortic prosthesis: A systematic review and meta-analysisThe Journal of Thoracic and Cardiovascular SurgeryVol. 149Issue 6PreviewThe Trifecta aortic prosthesis is a latest-generation trileaflet stented pericardial valve designed for supra-annular placement in the aortic position. Robust clinical evidence and long-term follow-up data for this new prosthesis are lacking; a systematic review was conducted to assess current evidence. Full-Text PDF Open Archive

BACKGROUND AND AIM OF THE STUDY:Increased life expectancy has resulted in the elderly frequently presenting with severe aortic stenosis. It has therefore become important to define indications for conventional aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI) in this patient population. Thus, patients aged > or = 70 years undergoing conventional isolated AVR were evaluated for predictors of early and late mortality.METHODS:A retrospective analysis was conducted of prospectively collected data available from 1,061 consecutive patients (age range: 70-94 years) who underwent isolated AVR between 1982 and 2002. The patient age groups were 70-74 years (n = 466), 75-79 years (n = 367), and > or = 80 years (n = 228). The mean follow up was 6.0 +/- 4.4 years, and the total follow up 6,390 patient-years. Twenty-two variables were considered as potential risk factors for early and late mortality.RESULTS:Early mortality was higher in patients aged > or = 80 years than in those aged 70-79 years. Early mortality in patients aged > or = 80 years was lower between 1998 and 2002 than between 1982 and 1997. Multivariate predictors of early mortality were age > or = 80 years, operative status, previous intervention, renal failure, and mitral regurgitation. The early nonfatal complication rate was similar for patients aged 70-79 years and > or = 80 years, but late mortality was lower between 1998 and 2002 than between 1982 and 1997 in patients aged 70-79 years, and in those aged > or = 80 years. The 10-year actuarial survivals after AVR in patients aged 70-74, 75-79, and > or = 80 years were 54 +/- 3.0%, 43 +/- 3.8% and 17 +/- 3.9%, respectively. Multivariate predictors of late mortality were age 75-79 years, age > or = 80 years, peripheral vascular disease (PVD) and chronic obstructive pulmonary disease (COPD). Female gender was shown to be protective.CONCLUSION:Early mortality was higher in patients aged > or = 80 years undergoing AVR, though this has declined recently and is currently at an acceptable level. Other important predictors of mortality in elderly patients undergoing AVR are operative status, previous interventions, renal failure, mitral regurgitation, male gender, PVD, and COPD. Thus, conventional AVR remains a safe treatment option for the elderly patient.

Objective: To assess the influence of gender on mortality after aortic valve replacement for aortic stenosis.Methods: A retrospective analysis was performed on data prospectively collected from all patients undergoing aortic valve replacement for aortic stenosis. Multivariate regression analysis was performed to evaluate the effect of 22 preoperative and operative variables on early, late, and overall mortality.Results: Aortic valve replacement was performed in 3343 patients with aortic stenosis between 1982 and 2003. The female patients were older, with a smaller body mass index. The women were less likely to have diabetes, chronic obstructive pulmonary disease, previous myocardial infarction, or left ventricular ejection fraction <35% but were more likely to have hypertension or a New York Heart Association III-IV classification. The female patients received a smaller prosthetic valve, with a smaller effective orifice area index (EOAI). The mean follow-up period was 6.18 +/- 4.96 years, with a total of 2066.142 years of follow-up. The independent predictors of early mortality for the male patients included age, concomitant surgical revascularization, congestive heart failure, and valve size of <= 21 mm. The independent predictors of late mortality for the male patients included age, concomitant surgical revascularization, diabetes, renal failure, chronic obstructive pulmonary disease, congestive heart failure, and a bioprosthetic valve. The independent predictors of overall mortality for the male patients included age, concomitant surgical revascularization, diabetes, renal failure, heart failure, and valve size of <= 21 mm. For the female patients, the risk factors for early mortality included body mass index <25 kg/m(2); for late mortality included age, concomitant surgical revascularization, New York Heart Association class III-IV, and diabetes; and for overall mortality included age, concomitant surgical revascularization, New York Heart Association class III-IV, and renal failure. Furthermore, male gender was an independent predictor of late (but not early or overall) mortality.Conclusions: The independent predictors of mortality after aortic valve replacement for aortic stenosis differed between the male and female patients. Male gender increased the risk of late mortality, and a valve size of <= 21 mm increased the risk of early and overall mortality among the male patients only. These differences need to be taken into consideration preoperatively and require consideration during operative management. (J Thorac Cardiovasc Surg 2011;142:595-601)

Background: The St Jude Medical Epic heart valve (St Jude Medical, Inc, St Paul, Minn) is a tricomposite glutaraldehyde-preserved porcine bioprosthesis. The St Jude Medical Biocor porcine bioprosthesis is the precursor valve to the St Jude Medical Epic valve. The Epic valve is identical to the Biocor valve except that it is treated with Linx AC ethanol-based calcium mitigation therapy.Methods: The St Jude Medical Epic valve was implanted in 761 patients (mean age 73.9 +/- 9.2 years) between 2003 and 2006 in the US Food and Drug Administration regulatory study in 22 investigational centers. The position distribution was 557 aortic valve replacements, 175 mitral valve replacements, and 29 double valve replacements. Concomitant coronary artery bypass grafting was performed in 50.8% of patients undergoing aortic valve replacement and 36.6% of those undergoing mitral valve replacement.Results: The early mortality was 3.6% in aortic and 2.3% in mitral valve replacement. The follow-up was 1675.5 patient-years with a mean of 2.2 +/- 1.2 years/patient. Late mortality was 5.2%/patient-year in aortic and 6.6%/patient-year in mitral valve replacement. The late major thromboembolism rate was 0.98%/patient-year for aortic and 2.6%/patient-year for mitral valve replacement. There were 19 reoperations, including 2 for structural valve deterioration, 1 for thrombosis, 9 for nonstructural dysfunction, and 7 for prosthetic valve endocarditis. The actuarial freedom from reoperation owing to structural valve deterioration for aortic valve replacement at 4 years for age 60 years or less was 93.3% +/- 6.4%; for ages 61 to 70 years, 98.1% +/- 1.9%; and for older than 70 years, 100%(P = .0006 > 70 vs <= 60 years). There were no events of structural deterioration with mitral valve replacement. The actuarial freedom from major thromboembolism for all patients at 4 years was 93.6% +/- 1.0%. The 2 cases of structural valve deterioration occurred in aortic valves that became perforated without calcification causing aortic regurgitation.Conclusions: The performance of the St Jude Medical Epic porcine bioprosthesis is satisfactory at 4 years for both aortic and mitral valve replacement. This study establishes the early clinical performance including durability of this porcine bioprosthesis. (J Thorac Cardiovasc Surg 2011; 141: 1449-54)

proof of the ''valve-in-valve'' concept

Background: The Mosaic porcine bioprosthesis (Medtronic, Inc, Minneapolis, Minn) was approved in 2000 by the US Food and Drug Administration. Clinical performance was evaluated in 6 centers.Methods: From 1994 to 2000, 797 patients (mean age 69 years) had aortic valve replacement (AVR) and 232 (mean 67 years) had mitral valve replacement (MVR). Concomitant coronary artery bypass grafting was performed with aortic valve replacement (45.4%) and mitral valve replacement (43.5%). Mean follow-ups were 7.5 years for aortic position and 7.3 years for mitral position.Results: Early mortalities were 2.8% for AVR and 3.0% for MVR. Late mortalities were 4.2%/patient-year for AVR and 5.1%/patient-year for MVR. Overall 12-year survivals were 55.8% +/- 3.7% for AVR and 43.9% +/- 7.4% for MVR. Twelve-year freedoms from valve-related mortality were 87.1% +/- 3.1% for AVR and 82.5% +/- 7.7% for MVR. Twelve-year freedoms from reoperation were 84.0% +/- 3.3% for AVR and 82.5% +/- 7.5% for MVR. Freedoms from structural valve deterioration (SVD) by explant reoperation at 12 years for AVR were 93.3% +/- 2.6% for patients at least 60 years old and 75.9% +/- 9.3% for patients younger than 60 years. Freedoms from SVD by explant reoperation at 10 years for MVR were 95.3% +/- 7.8% for patients at least 70 years old and 84.0% +/- 9.3% for patients younger than 70 years. Hemodynamic performance data at 1 year for AVR (sizes 21-27 mm) were mean systolic gradient range 13.7 +/- 4.8 to 10.3 +/- 3.2 mm Hg and effective orifice area range 1.5 +/- 0.3 to 2.5 +/- 0.4 cm(2). For MVR (sizes 25-31 mm), data were mean diastolic gradient range 6.7 +/- 1.7 to 3.7 +/- 0.9 mm Hg and effective orifice area range 1.9 +/- 0.3 to 2.4 +/- 0.6 cm(2).Conclusions: Overall performance of Mosaic porcine bioprosthesis to 12 years is satisfactory. Freedoms from SVD by explant reoperation were most satisfactory for aortic position in patients at least 60 years old and mitral position in patients at least 70 years old. Overall actuarial freedom from SVD by explant reoperation is encouraging for patients with MVR. (J Thorac Cardiovasc Surg 2011;142:302-307)