Use Of Tissue Valves Research Articles

Estimating the Potential Economic Impact of Tissue Valve Replacement for Heart Valve Disease in China: Patient-Level and Population-Level Cost-Benefit Simulation Analyses

ObjectivesThis study seeks to estimate the potential societal economic impact of treating patients with heart valve disease (HVD) in China with surgical tissue valve replacement versus mechanical valves. MethodsThis societal economic cost-benefit evaluation is based on an individual simulation model for subgroups of patients with HVD that is also aggregated to a macrosocietal model. The individual simulation model was developed to estimate the likely economic impact of surgical aortic valve replacement (SAVR) with tissue versus mechanical valves for different subgroups among all eligible patients with HVD over their remaining lifetimes. Clinical inputs were informed by health claims database analysis, expert clinical opinion, and published literature. Epidemiological inputs and demographic inputs were sourced from the published literature and the China Statistical Yearbook 2020. Health gains were valued at 3 times the average national income. ResultsProjected total lifetime economic gains were greater for patients receiving tissue valves. Costs were reported in 2021 US dollars. The average lifetime net economic gain for tissue valve patients was $51 736 (20.0% more than for mechanical valve patients). Increasing the use of tissue valves to 50% among all eligible patients with HVD would provide aggregate long-term economic gains of $167 billion during their remaining lifetimes. The economic gains from greater tissue valve use were due to avoiding anticoagulation monitoring costs, improved quality of life, and greater post-SAVR labor force participation. ConclusionIncreased use of tissue valves versus mechanical values in SAVR procedures in China would be likely to generate a substantial societal economic gain.

Early Outcomes of Emergency Surgery for Left-Sided Mechanical Valve Thrombosis.

Valve thrombosis is a potentially lethal complication of mechanical cardiac valves. We examined the clinical characteristics as well as the early outcomes of patients undergoing emergency surgery for left-sided mechanical valve thrombosis. Between January 2012 and May 2020, 104 consecutive patients were offered an emergency redo surgery for acute mechanical valve thrombosis. Ninety-seven of these patients were included in the current study. The mean age was 34.2 ± 10.3 years. Most of the patients were females (61 patients), and 27 patients (27.8%) were pregnant. The mitral valve was the site of thrombosis in 81 patients. Inadequate anticoagulation was found in 60.8% of patients. The overall early mortality was 32.9% (32 patients) with an operative mortality of 25.7%. Outcomes in the pregnant subgroup tended to be worst with a maternal mortality in the range of 37%, and with fetal and neonatal survival as low as 33.3%. The overall mortality in cases of mechanical valve thrombosis warranting surgery remains high. Since inadequate anticoagulation seems to be one of the major precipitating factors, the current study highlights the need for improvements in anticoagulation practices. The use of tissue valves should also be contemplated more seriously in some younger patients, especially females expressing the desire for future pregnancies.

Variablity of Mechanical or Tissue Valve Implantation in Patients Undergoing Surgical Aortic Valve Replacement in Spain: National Retrospective Analysis from 2007 to 2018.

Background: There is no robust evidence regarding the types of valves implanted among patients undergoing surgical aortic valve replacement (SAVR) in Spain. Methods: All cases of patients undergoing SAVR ± coronary artery bypass grafting from January 2007 to December 2018 in the public Spanish National Health System were included. We analyzed the trends of SAVR volume, risk profile and type of implanted valve across time and place. Using multivariable logistic regression, we identified factors associated with biological SAVR. Results: In total, 62,870 episodes of SAVR in 15 Spanish territories were included. In 35,693 (56.8%), a tissue valve was implanted. The annual volume of procedures increased from 107.3/million (2007) to 128.6 (2017). In 2018, it fell to 108.5. Age increased and Charlson’s comorbity index worsened throughout the study period. Tissue valve implantation increased in most regions. After adjusting for other covariates, we observed a high variability in aortic valve implantation across different regions, with differences of as much as 20-fold in the use of tissue valves. Conclusions: Between 2007 and 2018, we detected a significant increase in the use of bioprostheses in patients undergoing SAVR in Spain, and a great variability in the types of valve between the Spanish territories, which was not explained by the different risk profiles of patients.

Long-term Healthcare Expenditures Over Time for Tissue and Mechanical Aortic Valve Replacement

Guidelines currently indicate the use of surgical aortic valve replacement (SAVR) to treat severe cases of aortic stenosis, particularly for low- to medium-risk patients. Although several studies have compared health outcomes of tissue and mechanical SAVR, this economic simulation model estimates the difference in long-term healthcare costs associated with tissue relative to mechanical SAVR. The deterministic and Monte Carlo simulation models used literature-based epidemiologic and cost inputs to calculate annual expenditures related to SAVR for up to 25 years after initial surgery. A series of 3 cohort studies across different age groups provided the health outcome probabilities for tissue valve patients. Outcome probabilities for mechanical valve patients were based on relative risks reported in comparative meta-analyses or large cohort studies. Relative to mechanical SAVR the expected net discounted savings for a patient receiving tissue SAVR at ages 45, 55, and 65 years were $12,266, $15,462, and $16,008, respectively (based on 2018 US dollars) over a 25-year horizon (95% confidence intervals exceed $0). For a 45-year-old tissue SAVR patient, the estimated per-patient cost difference (relative to mechanical SAVR) of reoperation over 25 years ($16,201) were offset by expected savings on anticoagulation monitoring ($26,257) over the same period. In a sensitivity analysis in which mortality risk was assumed equal, significant long-term savings associated with tissue SAVR still accrued in each of the 3 age cohorts. Payers, providers, and the healthcare system may financially benefit from the use of tissue valves because significant savings were associated with the use of tissue valves relative to mechanical valves for SAVR.

Survival of Kidney Transplantation Patients in the United States After Cardiac Valve Replacement

Few published studies address the survival of kidney transplantation patients after valve surgery, and none address relative outcomes related to tissue versus nontissue prosthesis. This study aimed to assess survival of US kidney transplantation patients after cardiac valve replacement and to compare associations of valve selection. Of 1 698 706 patients in the US Renal Data System database, we identified 1335 kidney transplantation patients hospitalized in 1991 to 2004 for cardiac valve replacement. Survival was estimated by the Kaplan-Meier method; independent predictors of death were examined in a comorbidity-adjusted (by Charlson and propensity score) Cox model. Of the cohort, 17% were 0 to 44 years of age, 50% were 45 to 64 years of age, 28% were 65 to 74 years of age, and 5% were > or =75 years of age; 78% were white; 63% were men; and 20% had kidney failure caused by diabetes mellitus. Of 369 patients (28%) who received tissue valves, 75% had aortic valve replacement, 20% had mitral valve replacement, and 5% had both. Use of tissue valves increased from 13% in 1991 to 1995 to 38% in 2000 to 2004. Age, diabetes mellitus, and combined aortic and mitral valve replacement were the strongest predictors of all-cause mortality. In-hospital mortality was 14.0% overall, 11.4% for tissue-valve patients, and 15.0% for nontissue-valve patients (P=0.09). Two-year survival estimates were 61.5% for tissue-valve and 59.5% for nontissue-valve patients (P=0.30). The adjusted hazard ratio of death for tissue- versus nontissue-valve patients was 0.83 (95% confidence interval, 0.70 to 0.99). Renal transplantation patients requiring valve replacement have high mortality rates ( approximately 20%/y). These data suggest minimally reduced mortality risk for patients receiving tissue versus nontissue valves.

Current status of the mechanical valve and bioprosthesis in Japan

The American College of Cardiology/American Heart Association guidelines for the management of patients with valvular heart disease were revised in 2006. These guidelines are introduced in this review, and the current status of the mechanical valve, bioprosthesis, and treatment of valvular heart disease are described based on the new guidelines as compared with the guidelines of 1998. The trend in valve selection in aortic valve replacement in the United States has been toward bioprosthesis, away from the mechanical valve. The reasons are: 1) current bioprostheses appear to have lower rates of structural valve deterioration, 2) the risks of reoperation have continued to decrease, 3) patients undergoing AVR today represent an older population than those in studies in randomized trials, 4) young patients undergoing AVR are often reluctant to accept warfarin therapy, 5) some large comparative trials have shown apparent survival benefit for patients receiving bioprostheses. In Japan, the use of tissue valves has been increasing and may continue to increase owing to the nation's aging population and to the reasons mentioned above. However, more patients received mechanical valves than bioprostheses for mitral valve replacement both in the United States and in Japan. The number of mitral valve repair cases has increased more than that of valve replacement. In selection of valve prosthesis for valve surgery, it is important that patients should decide by themselves based on mutual respect and trust between patient and doctor, with thorough discussion of the possibility of redo surgery and its risks, life-long warfarin intake, quality of life, and the patient's lifestyle and outlook on life.

Choice of Prosthetic Heart Valve in Today’s Practice

In this update, current guidelines addressing prosthesis selection published by the American College of Cardiology/American Heart Association (ACC/AHA) and the European Society of Cardiology (ESC) are discussed, along with additional data that affect choices in valve prostheses. The case of a 50-year-old man undergoing aortic valve replacement is used to address anticipated operative mortality, risk of reoperation, and valve-related morbidity and mortality. The apparent advantages associated with the use of a bioprosthesis even in a relatively young patient help to explain current clinical trends toward the increasing use of tissue valves. We also provide a simplified algorithm that may be used to facilitate the choice of valve procedure in patients with heart valve disease. The outcomes after surgery for valvular heart disease in terms of survival, functional status, and quality of life are determined primarily by patient-related factors such as age, ventricular function, and other comorbidities.1 However, outcomes also are influenced by surgical factors; the best clinical outcomes often are associated with valve repair, although mitral repair is not always possible and aortic valve repair in adults remains the exception rather than the rule. For patients who require valve replacement, the valve prosthesis can significantly influence outcome. The ideal prosthetic valve that combines excellent hemodynamic performance and long-term durability without increased thromboembolic risk or the need for long-term anticoagulation does not exist. Hence, patients and their physicians need to choose between a mechanical and a tissue (bioprosthetic) valve. In general, the advantageous durability of mechanical valves is offset by the risk of thromboembolism and the need for long-term anticoagulation and its associated risk of bleeding. In contrast, bioprosthetic valves do not require long-term anticoagulation yet carry the risk of structural failure and reoperation.2,3 Two historic randomized clinical trials compared outcomes after valve replacement with a first-generation porcine heterograft …

Percutaneous and surgical treatment of aortic stenosis

Aortic stenosis due to calcific degeneration is the most common valvular disorder among the elderly. With the growing elderly population, the prevalence of this disease will continue to increase. Based on converging lines of evidence linking calcific aortic stenosis with atherosclerosis, there has been interest in drug therapy to slow the progression of aortic stenosis. Unfortunately, recently completed prospective trials have been disappointing. Mechanical measures remain the principal form of therapy. Among percutaneous techniques, aortic valvuloplasty provides only transient and modest benefit at a significant risk of stroke and vascular injury. However, aortic valvuloplasty can play a useful role in stabilizing patients who require additional attention prior to definitive surgery. Building on this foundation, a bold new technique of percutaneously implanting a balloon-mounted valve has been developed. Although promising, there have been relatively few patients treated in this fashion (at a single center) and with only limited follow-up. Surgical treatment, specifically valve replacement, is still the definitive treatment of choice for patients with symptomatic aortic stenosis. Surgeons and patients must choose between a variety of models of both tissue and mechanical valves and a variety of surgical approaches. Recent trends include the use of tissue valves in increasingly younger patients and continued interest in alternatives to full median sternotomy in approaching the valve.

Quality of life after aortic valve replacement with tissue and mechanical implants

Objectives We sought to determine whether changes in quality of life at 18 months following aortic valve replacement differ depending on the use of tissue valves or mechanical valves. Methods We prospectively studied 73 patients with tissue valve replacements and 53 patients with mechanical valve replacements performed from April 1998 through March 1999 at Yale-New Haven Hospital. Quality of life was measured at baseline and at 18 months using the Medical Outcomes Trust Short Form 36-Item Health Survey. Results Baseline unadjusted mean quality-of-life scores were lower in tissue valve recipients than in mechanical valve recipients and, for both groups, were generally lower than US population norms. At 18 months postoperatively, quality-of-life scores were greatly improved in both groups and were comparable to population norms (ie, within one-half a standard deviation). After adjusting for baseline quality of life, age, and other prognostic factors in an analysis of covariance, improvements in quality-of-life scores for tissue valve recipients versus mechanical valve recipients were similar. Of 10 (8 domains and 2 summary) scales examined, the only significant difference between the 2 groups was for the improvement in role limitations due to physical problems (Role Physical), which was more favorable in patients with mechanical valve implants ( P = .04). Conclusions The use of tissue valve implants versus mechanical valve implants has little influence on improvement in quality of life at 18 months following aortic valve replacement. Thus, decisions about whether to choose a tissue valve or mechanical valve implant should depend upon other factors such as rates of complications and differences in the life span of the implants.

Perioperative considerations in the patient with a left ventricular assist device.

Perioperative considerations in the patient with a left ventricular assist device.

Long-term survival of dialysis patients in the United States with prosthetic heart valves: should ACC/AHA practice guidelines on valve selection be modified?

Minimal data exist on the long-term survival of dialysis patients after cardiac valve surgery. Current practice guidelines of the American College of Cardiology/American Heart Association Task Force on the management of patients with valvular heart disease proscribe the use of bioprosthetic (tissue) valves in hemodialysis patients. Dialysis patients hospitalized for heart valve replacement surgery from 1978 to 1998 were retrospectively identified from the US Renal Data System database. Long-term survival was estimated by the life-table method. The impact of demographic differences and comorbidity on outcome were examined in a Cox proportional hazards model. The in-hospital mortality of 5858 dialysis patients undergoing valve surgery was 20.7%. Aortic valve replacement was performed in 3415 patients (58%), mitral valve replacement in 1848 patients (32%), and combined aortic and mitral valve replacement in 562 patients (10%). Tissue valves were used in 881 patients. There was no significant difference in survival related to type of prosthetic valve. The 2-year survival rate was 39.7+/-3.5% with tissue valves versus 39.7+/-1.4% for nontissue valves. Compared with nontissue prosthetic valves, the use of tissue valves was not predictive of death (RR 0.98; 95% CI 0.90 to 1.07). There is no significant difference in survival of dialysis patients after cardiac valve replacement with tissue versus nontissue prosthetic valves. Current practice guidelines proscribing the use of bioprosthetic heart valves in hemodialysis patients should be rescinded.

Aortic valve exposure through a combined right atrial-ascending aortic approach in redo cases

The expanded use of tissue valves in the aortic position lead to an increased number of reoperations in cases of valve failure. The approach to an aortic prosthesis can be difficult because of heavy adhesions, especially if biological glue was used in the first procedure and the interval between the first and second operation is short.

Pregnancy and Mechanical Valve Prostheses: A High-Risk Situation for the Mother and the Fetus

Thirty-eight women with mechanical valve prostheses had a total of 47 pregnancies. All patients were on oral anticoagulants before pregnancy. A high incidence of complications was seen in both the mothers and the fetuses. The rate of spontaneous abortion was 23.4% (11/47), and 2 of the 36 newborns had chondrodysplasia punctata. Three of the women (7.9%) had acute valvular thrombosis; 1 died after replacement of the thrombosed valve. Thus, the overall mortality for the series was 2.6%. More complications were observed in the fetuses and infants of women treated with oral anticoagulants during pregnancy than in women treated with heparin. However, the mothers had more complications with heparin anticoagulation. Neither heparin nor oral anticoagulants clearly proved superior as the anticoagulation regimen of choice for pregnant women with mechanical valves. Counseling before conception occurs and avoidance of pregnancy are recommended for women with mechanical valve prostheses because of the high risk of serious or fatal complications in the mother and fetus. Use of tissue valves in women of childbearing age who desire to have children also seems advisable, even with the possibility of having to undergo another operation as a result of degeneration of the valve tissue.