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The European Journal of Health... Mar 2018To review the evidence on the cost-effectiveness of heart valve implantations generated by decision analytic models and to assess their methodological quality. (Review)
Review
OBJECTIVE
To review the evidence on the cost-effectiveness of heart valve implantations generated by decision analytic models and to assess their methodological quality.
METHODS
A systematic review was performed including model-based cost-effectiveness analyses of heart valve implantations. Study and model characteristics and cost-effectiveness results were extracted and the methodological quality was assessed using the Philips checklist.
RESULTS
Fourteen decision-analytic models regarding the cost-effectiveness of heart valve implantations were identified. In most studies transcatheter aortic valve implantation (TAVI) was cost-effective compared to standard treatment (ST) in inoperable or high-risk operable patients (ICER range 18,421-120,779 €) and in all studies surgical aortic valve replacement (SAVR) was cost-effective compared to ST in operable patients (ICER range 14,108-40,944 €), but the results were not consistent on the cost-effectiveness of TAVI versus SAVR in high-risk operable patients (ICER range: dominant to dominated by SAVR). Mechanical mitral valve replacement (MVR) had the lowest costs per success compared to mitral valve repair and biological MVR. The methodological quality of the studies was moderate to good.
CONCLUSION
This review showed that improvements can be made in the description and justification of methods and data sources, sensitivity analysis on extrapolation of results, subgroup analyses, consideration of methodological and structural uncertainty, and consistency (i.e. validity) of the models. There are several opportunities for future decision-analytic models of the cost-effectiveness of heart valve implantations: considering heart valve implantations in other valve positions besides the aortic valve, using a societal perspective, and developing patient-simulation models to investigate the impact of patient characteristics on outcomes.
Topics: Aortic Valve Stenosis; Cost-Benefit Analysis; Heart Valve Prosthesis Implantation; Heart Valves; Humans; Models, Economic; Risk Assessment
PubMed: 28265822
DOI: 10.1007/s10198-017-0880-z -
Journal of Cardiothoracic Surgery Apr 2023New technologies for the treatment of Aortic Stenosis are evolving to minimize risk and treat an increasingly comorbid population. The Sutureless Perceval Valve is one... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
New technologies for the treatment of Aortic Stenosis are evolving to minimize risk and treat an increasingly comorbid population. The Sutureless Perceval Valve is one such alternative. Whilst short-term data is promising, limited mid-term outcomes exist, until now. This is the first systematic review and meta-analysis to evaluate mid-term outcomes in the Perceval Valve in isolation.
METHODS
A systematic literature review of 5 databases was performed. Articles included evaluated echocardiographic and mortality outcomes beyond 5 years in patients who had undergone Perceval Valve AVR. Two reviewers extracted and reviewed the articles. Weighted estimates were performed for all post-operative and mid-term data. Aggregated Kaplan Meier curves were reconstructed from digitised images to evaluate long-term survival.
RESULTS
Seven observational studies were identified, with a total number of 3196 patients analysed. 30-day mortality was 2.5%. Aggregated survival at 1, 2, 3, 4 and 5 years was 93.4%, 89.4%, 84.9%, 82% and 79.5% respectively. Permanent pacemaker implantation (7.9%), severe paravalvular leak (1.6%), structural valve deterioration (1.5%), stroke (4.4%), endocarditis (1.6%) and valve explant (2.3%) were acceptable at up to mid-term follow up. Haemodynamics were also acceptable at up mid-term with mean-valve gradient (range 9-13.6 mmHg), peak-valve gradient (17.8-22.3 mmHg) and effective orifice area (1.5-1.8 cm) across all valve sizes. Cardiopulmonary bypass (78 min) and Aortic cross clamp times (52 min) were also favourable.
CONCLUSION
To our knowledge, this represents the first meta-analysis to date evaluating mid-term outcomes in the Perceval Valve in isolation and demonstrates good 5-year mortality, haemodynamic and morbidity outcomes.
KEY QUESTION
What are the mid-term outcomes at up to 5 years follow up in Perceval Valve Aortic Valve Replacement?
KEY FINDINGS
Perceval Valve AVR achieves 80% freedom from mortality at 5 years with low valve gradients and minimal morbidity.
KEY OUTCOMES
Perceval Valve Aortic Valve Replacement has acceptable mid-term mortality, durability and haemodynamic outcomes.
Topics: Humans; Heart Valve Prosthesis Implantation; Follow-Up Studies; Heart Valve Prosthesis; Aortic Valve; Aortic Valve Stenosis
PubMed: 37041628
DOI: 10.1186/s13019-023-02273-7 -
The American Journal of Cardiology Nov 2023This systematic review and meta-analysis aimed to investigate whether percutaneous mitral valve repair (PMVr) using MitraClip was more effective than surgery or medical... (Meta-Analysis)
Meta-Analysis Review
This systematic review and meta-analysis aimed to investigate whether percutaneous mitral valve repair (PMVr) using MitraClip was more effective than surgery or medical therapy for long-term morbidity and mortality. We searched MEDLINE, EMBASE, and CENTRAL (Cochrane Library) databases to identify relevant studies that recruited adult patients with functional or secondary mitral valve regurgitation who underwent PMVr with MitraClip implantation using appropriate search terms and Boolean operators. The odds ratios (ORs) were pooled using the random-effects model. A total of 14 studies recruiting 2,593 patients were included. Within 12 months of follow-up, patients who underwent PMVr did not maintain mitral valve regurgitation grade 2+ (OR 0.22, 95% confidence interval [CI] 0.12 to 0.41, p <0.0001, I = 0.0%, p = 0.52) or symptom-free heart failure (OR 0.47, 95% CI 0.29 to 0.77, p = 0.0028, I = 0.0%, p = 0.66) compared with their surgical counterparts. Patients were more likely to be rehospitalized for heart failure (OR 2.79, 95% CI 1.54 to 5.05, p = 0.0007, I = 0.0%, p = 0.51). However, there was no difference between the groups in terms of all-cause or cardiovascular mortality. Whereas, in comparison with medical therapy, PMVr significantly reduced all-cause mortality at 12 and ≥24 months of follow-up (OR 0.41, 95% CI 0.24, 0.69, p = 0.0009, I = 32%, p = 0.23 and OR 0.55, 95% CI 0.40, 0.75, p = 0.0002, I = 0.0%, p = 0.45, respectively). In conclusion, there was no difference in all-cause death at 12 or 24 months of follow-up between PMVr and the surgical approach, but the durability of valvular repair was inferior with PMVr. In comparison with medical therapy, there was a significant reduction in mortality with PMVr.
Topics: Adult; Humans; Mitral Valve Insufficiency; Mitral Valve; Treatment Outcome; Cardiac Surgical Procedures; Heart Failure; Heart Valve Prosthesis Implantation
PubMed: 37741106
DOI: 10.1016/j.amjcard.2023.08.097 -
JACC. Basic To Translational Science May 2023Tissue-engineered heart valves (TEHVs) are emerging alternatives to current valve prostheses and prospectively a lifelong replacement. Calcification, a pathological... (Review)
Review
Tissue-engineered heart valves (TEHVs) are emerging alternatives to current valve prostheses and prospectively a lifelong replacement. Calcification, a pathological complication for biological protheses, has been reported in preclinical TEHV studies. Systematic analysis of its occurrence is missing. This review aims to: 1) systematically review reported calcification of pulmonary TEHVs in large-animal studies; and 2) analyze the influence of engineering methodology (choice of scaffold material, cell preseeding) and animal model (animal species and age) on calcification. Baseline analysis included 80 studies, of which 41 studies containing 108 experimental groups were included in meta-analysis. Inclusion was low because only 55% of studies reported on calcification. Meta-analysis showed an overall average calcification event rate of 35% (95% CI: 28%-43%). Calcification was more prominent ( 0.023) in the arterial conduit region (34%; 95% CI: 26%-43%) than in the valve leaflets (21%; 95% CI: 17%-27%), and was mostly (42% in leaflets, 60% in conduits) present in a mild form. Time-analysis showed an initial surge within 1 month after implantation, decreased calcification between 1 and 3 months, and then progression over time. There were no significant differences in degree of calcification between TEHV strategy nor animal models. Much variability between individual studies was observed in degree of calcification as well as quality of analysis and reporting thereof, hampering adequate comparisons between studies. These findings underline the need for improved analysis and better reporting standards of calcification in TEHVs. It also necessitates control-based research to further enlighten the risk of calcification for tissue-engineered transplants compared to current options. This can bring the field of heart valve tissue engineering forward toward safe clinical use.
PubMed: 37325410
DOI: 10.1016/j.jacbts.2022.09.009 -
Frontiers in Cardiovascular Medicine 2021New antithrombotic drugs have been developed, new valve types have been designed and minimally invasive transcatheter techniques have emerged, making the choice of...
New antithrombotic drugs have been developed, new valve types have been designed and minimally invasive transcatheter techniques have emerged, making the choice of antithrombotic therapy after surgical or transcatheter heart valve repair and replacement increasingly complex. Moreover, due to a lack of large randomized controlled trials many recommendations for antithrombotic therapy are based on expert opinion, reflected by divergent recommendations in current guidelines. Therefore, decision-making in clinical practice regarding antithrombotic therapy for prosthetic heart valves is difficult, potentially resulting in sub-optimal patient treatment. This article compares the 2017 ESC/EACTS and 2020 ACC/AHA guidelines on the management of valvular heart disease and summarizes the available evidence. Finally, we established a convenient consensus on antithrombotic therapy after valve interventions based on over 800 annual cases of surgical and transcatheter heart valve repair and replacement and a multidisciplinary team discussion between the department of cardiovascular diseases and cardiac surgery of the University Hospitals Leuven, Belgium.
PubMed: 34422930
DOI: 10.3389/fcvm.2021.702780 -
Journal of Clinical Medicine Aug 2022spp. are non-motile, facultative anaerobic, Gram-negative coccobacilli that are commonly found in the oral cavity and the gastrointestinal tract of some animals and are... (Review)
Review
spp. are non-motile, facultative anaerobic, Gram-negative coccobacilli that are commonly found in the oral cavity and the gastrointestinal tract of some animals and are known to be the cause of infections. Usually, infections by spp. in humans is more common in the context of an animal bite leading to a skin and soft tissue infection (SSTI). Infective endocarditis (IE) is rarely caused by spp.; however, it can pose diagnostic and therapeutic dilemmas due to its rarity. The aim of the present study was to systematically review all cases of IE by spp. in the literature. A systematic review was performed of PubMed, Scopus and the Cochrane Library (through 20 December 2021) for studies providing data on epidemiology and clinical and microbiological characteristics as well as data on treatment and outcomes of IE by spp. A total of 28 studies containing data for 28 patients were included. Prosthetic valve was present in 21.4% of patients. The aorta was the most commonly involved intracardiac site. Fever, sepsis, septic shock and heart failure were the most common clinical presentations. Cephalosporins, aminopenicillins and penicillin were the antimicrobials used most commonly. Overall mortality was 17.9%.
PubMed: 36078964
DOI: 10.3390/jcm11175037 -
Tropical Medicine and Infectious Disease Feb 2021spp. are non-spore-forming Gram-negative bacilli. They comprise only three species known to cause disease in humans, namely , and . Since infective endocarditis (IE)... (Review)
Review
spp. are non-spore-forming Gram-negative bacilli. They comprise only three species known to cause disease in humans, namely , and . Since infective endocarditis (IE) is rarely caused by , the management of these infections can be problematic due to the lack of experience. The purpose of this study was to systematically review all published cases of IE by species in the literature. A systematic review of PubMed, Scopus and Cochrane Library (through 1 November 2020) for studies providing epidemiological, clinical and microbiological information as well as data on treatment and outcomes of IE caused by species was performed. A total of 12 studies, containing data of 12 patients, were included. A prosthetic valve was present in 17% of patients. The mitral valve was the most commonly infected site, followed by the aortic valve. Fever, sepsis and embolic phenomena were common clinical signs, followed by heart failure. Aminoglycosides, cephalosporins and quinolones were the most commonly used antimicrobials. Clinical cure was noted in 83%, while overall mortality was 17%. This systematic review describes IE by and provides information on patients' epidemiology, clinical signs and the related therapeutic strategies and outcomes.
PubMed: 33540800
DOI: 10.3390/tropicalmed6010019 -
Journal of Thrombosis and Thrombolysis Apr 2023Since the beginning of the SARS-CoV-2 (COVID-19) pandemic, correlation of venous thromboembolism (VTE) and COVID-19 infection has been well established. Increased... (Review)
Review
Since the beginning of the SARS-CoV-2 (COVID-19) pandemic, correlation of venous thromboembolism (VTE) and COVID-19 infection has been well established. Increased inflammatory response in the setting of COVID-19 infection is associated with VTE and hypercoagulability. Venous and arterial thrombotic events in COVID-19 infection have been well documented; however, few cases have been reported involving cardiac valve prostheses. In this review, we present a total of eight cases involving COVID-19-related prosthetic valve thrombosis (PVT), as identified in a systematic review. These eight cases describe valve position (mitral versus aortic) and prosthesis type (bioprosthetic versus mechanical), and all cases demonstrate incidents of PVT associated with simultaneous or recent COVID-19 infection. None of these eight cases display obvious non-adherence to anticoagulation; five of the cases occurred greater than three years after the most recent valve replacement. Our review offers insights into PVT in COVID-19 infected patients including an indication for increased monitoring in the peri-infectious period. We explore valve thrombosis as a mechanism for prosthetic valve failure. We describe potential differences in antithrombotic strategies that may offer added antithrombotic protection during COVID-19 infection. With the growing population of valve replacement patients and recurring COVID-19 infection surges, it is imperative to explore relationships between COVID-19 and PVT.
Topics: Humans; Fibrinolytic Agents; Venous Thromboembolism; COVID-19; SARS-CoV-2; Heart Valve Diseases; Heart Valve Prosthesis; Thrombosis; Aortic Valve
PubMed: 36528721
DOI: 10.1007/s11239-022-02746-x -
European Journal of Cardio-thoracic... Sep 2023To support clinical decision-making in children with aortic valve disease, by compiling the available evidence on outcome after paediatric aortic valve repair (AVr). (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To support clinical decision-making in children with aortic valve disease, by compiling the available evidence on outcome after paediatric aortic valve repair (AVr).
METHODS
A systematic review of literature reporting clinical outcome after paediatric AVr (mean age at surgery <18 years) published between 1 January 1990 and 23 December 2021 was conducted. Early event risks, late event rates and time-to-event data were pooled. A microsimulation model was employed to simulate the lives of individual children, infants and neonates following AVr.
RESULTS
Forty-one publications were included, encompassing 2 623 patients with 17 217 patient-years of follow-up (median follow-up: 7.3 years; range: 1.0-14.4 years). Pooled mean age during repair for aortic stenosis in children (<18 years), infants (<1 year) or neonates (<30 days) was 5.2 ± 3.9 years, 35 ± 137 days and 11 ± 6 days, respectively. Pooled early mortality after stenosis repair in children, infants and neonates, respectively, was 3.5% (95% confidence interval: 1.9-6.5%), 7.4% (4.2-13.0%) and 10.7% (6.8-16.9%). Pooled late reintervention rate after stenosis repair in children, infants and neonates, respectively, was 3.31%/year (1.66-6.63%/year), 6.84%/year (3.95-11.83%/year) and 6.32%/year (3.04-13.15%/year); endocarditis 0.07%/year (0.03-0.21%/year), 0.23%/year (0.07-0.71%/year) and 0.49%/year (0.18-1.29%/year); and valve thrombosis 0.05%/year (0.01-0.26%/year), 0.15%/year (0.04-0.53%/year) and 0.19%/year (0.05-0.77%/year). Microsimulation-based mean life expectancy in the first 20 years for children, infants and neonates with aortic stenosis, respectively, was 18.4 years (95% credible interval: 18.1-18.7 years; relative survival compared to the matched general population: 92.2%), 16.8 years (16.5-17.0 years; relative survival: 84.2%) and 15.9 years (14.8-17.0 years; relative survival: 80.1%). Microsimulation-based 20-year risk of reintervention in children, infants and neonates, respectively, was 75.2% (72.9-77.2%), 53.8% (51.9-55.7%) and 50.8% (47.0-57.6%).
CONCLUSIONS
Long-term outcomes after paediatric AVr for stenosis are satisfactory and dependent on age at surgery. Despite a high hazard of reintervention for valve dysfunction and slightly impaired survival relative to the general population, AVr is associated with low valve-related event occurrences and should be considered in children with aortic valve disease.
Topics: Infant, Newborn; Humans; Child; Infant; Adolescent; Aortic Valve; Heart Valve Prosthesis Implantation; Heart Valve Prosthesis; Constriction, Pathologic; Aortic Valve Stenosis; Treatment Outcome; Retrospective Studies; Reoperation
PubMed: 37584683
DOI: 10.1093/ejcts/ezad284 -
The Journal of Thoracic and... Jan 2016Despite an increasing interest in pediatric aortic valve repair, aortic valve replacement in children may be unavoidable. The evidence on outcome after pediatric aortic... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Despite an increasing interest in pediatric aortic valve repair, aortic valve replacement in children may be unavoidable. The evidence on outcome after pediatric aortic valve replacement is limited and usually reported in small case series. This systematic review and meta-analysis aims to provide an overview of reported outcome of pediatric patients after aortic valve replacement.
METHODS
A systematic literature search for publications reporting outcome after pediatric aortic valve replacement published between January 1990 and May 2015 was conducted. Studies written in English with a study size of more than 30 patients were included.
RESULTS
Thirty-four publications reporting on 42 cohorts were included in this review: 26 concerning the Ross procedure (n = 2409), 13 concerning mechanical prosthesis aortic valve replacement (n = 696), and 3 concerning homograft aortic valve replacement (n = 224). There were no studies on bioprostheses that met our inclusion criteria. The pooled mean patient age was 9.4 years, 12.8 years, and 8.9 years for Ross, mechanical prosthesis, and homograft recipients, respectively. Pooled mean follow-up was 6.6 years. The Ross procedure was associated with lower early (4.20%; 95% confidence interval [CI], 3.37-5.22 vs 7.34%; 95% CI, 5.21-10.34 vs 12.82%; 95% CI, 8.91-18.46) and late mortality (0.64%/y; 95% CI, 0.49-0.84 vs 1.23%/y; 95% CI, 0.85-1.79 vs 1.59%/y; 95% CI, 1.03-2.46) compared with mechanical prosthesis aortic valve replacement and homograft aortic valve replacement, respectively. No significantly different aortic valve reoperation rates were observed between the Ross procedure and mechanical prosthesis aortic valve replacement (1.60%/y; 95% CI, 1.27-2.02 vs 1.07%/y; 95% CI, 0.68-1.68, respectively), whereas homograft aortic valve replacement was associated with significantly higher aortic valve reoperation rates (5.44%/y; 95% CI, 4.24-6.98). The Ross procedure-associated right ventricular outflow tract reoperation rate was 1.91% per year (95% CI, 1.50-2.44).
CONCLUSIONS
This systematic review illustrates that all currently available aortic valve substitutes are associated with suboptimal results in children, reflecting the urgent need for reliable and durable repair techniques and innovative replacement solutions for this challenging group of patients.
Topics: Adolescent; Age Factors; Allografts; Aortic Valve; Chi-Square Distribution; Child; Child, Preschool; Heart Valve Diseases; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Hemodynamics; Humans; Infant; Postoperative Complications; Prosthesis Design; Reoperation; Risk Factors; Time Factors; Treatment Outcome
PubMed: 26541831
DOI: 10.1016/j.jtcvs.2015.09.083