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Sex-Related Differences in Transcatheter Mitral Valve Repair: A Systematic Review and Meta-Analysis.Cardiology 2022Inequalities in postoperative outcomes between males and females are well described with females often experiencing inferior outcomes after heart valve surgery. The... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Inequalities in postoperative outcomes between males and females are well described with females often experiencing inferior outcomes after heart valve surgery. The recent literature has demonstrated equivalent or improved outcomes for females after transcatheter aortic valve replacement. Transcatheter mitral valve repair (TMVr) and replacement (TMVR) is a relatively newer field with significantly less literature comparing sex differences. This systematic review and meta-analysis looks to provide a comprehensive summary of the published literature comparing outcomes between males and females undergoing transcatheter MV interventions.
METHODS
PubMed, MEDLINE, and Scopus were systematically searched for all studies comparing outcomes between males and females undergoing TMVr and TMVR. A total of 2,178 English manuscript titles and abstracts were reviewed. Articles were excluded if data were not provided regarding sex differences, transcatheter MV intervention, full-length text was not accessible, or if insufficient data was provided. A total of 2,170 articles were excluded, and 8 articles were included in this study.
RESULTS
Pooled estimates of outcomes demonstrated rates of acute kidney injury (OR 1.28 [95% CI, 1.14-1.44; p < 0.0001]) favored females, while rates of major bleeding favored males (OR 0.85 [95% CI 0.76-0.96; p = 0.01]). Rates of mortality, postoperative MI, and stroke did not differ significantly.
CONCLUSION
A trend has emerged in heart valve interventions with males tending to have improved outcomes after surgical intervention and females experiencing equivalent or improved outcomes after transcatheter interventions. This meta-analysis identified increased rates of acute kidney injury for males, increased rates of major bleeding for females, and otherwise comparable morbidity and mortality in males and females undergoing TMVr.
Topics: Acute Kidney Injury; Cardiac Catheterization; Female; Heart Valve Prosthesis Implantation; Humans; Male; Mitral Valve; Mitral Valve Insufficiency; Sex Characteristics; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 35443246
DOI: 10.1159/000524378 -
Heart (British Cardiac Society) Aug 2021The review aims to summarise evidence addressing patients' values, preferences and practical issues on deciding between transcatheter aortic valve insertion (TAVI) and...
The review aims to summarise evidence addressing patients' values, preferences and practical issues on deciding between transcatheter aortic valve insertion (TAVI) and surgical aortic valve replacement (SAVR) for aortic stenosis. We searched databases and grey literature until June 2020. We included studies of adults with aortic stenosis eliciting values and preferences about treatment, excluding medical management or palliative care. Qualitative findings were synthesised using thematic analysis, and quantitative findings were narratively described. Evidence certainty was assessed using CERQual (Confidence in the Evidence from Reviews of Qualitative Research) and GRADE (Grading of Recommendations Assessment, Development and Evaluation). We included eight studies. Findings ranged from low to very low certainty. Most studies only addressed TAVI. Studies addressing both TAVI and SAVR reported on factors affecting patients' decision-making along with treatment effectiveness, instead of trade-offs between procedures. Willingness to accept risk varied considerably. To improve their health status, participants were willing to accept higher mortality risk than current evidence suggests for either procedure. No study explicitly addressed valve reintervention, and one study reported variability in willingness to accept shorter duration of known effectiveness of TAVI compared with SAVR. The most common themes were desire for symptom relief and improved function. Participants preferred minimally invasive procedures with shorter hospital stay and recovery. The current body of evidence on patients' values, preferences and practical issues related to aortic stenosis management is of suboptimal rigour and reports widely disparate results regarding patients' perceptions. These findings emphasise the need for higher quality studies to inform clinical practice guidelines and the central importance of shared decision-making to individualise care fitted to each patient.
Topics: Aortic Valve Stenosis; Decision Making; Heart Valve Prosthesis Implantation; Humans; Patient Preference; Quality-Adjusted Life Years; Risk Adjustment; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 33563630
DOI: 10.1136/heartjnl-2020-318334 -
Annals of Cardiothoracic Surgery Sep 2020The treatment of aortic valve disease is the most common valvular surgery in industrialized nations, with 3-9% of the population over the age of eighty having at least...
BACKGROUND
The treatment of aortic valve disease is the most common valvular surgery in industrialized nations, with 3-9% of the population over the age of eighty having at least moderate aortic stenosis. As transcatheter aortic valve replacement (TAVR) has become more established, newer surgical prostheses have been developed with a variety of anchoring systems that do not rely solely on sutures to hold the valve in an appropriate position. The Edwards Intuity valve is a bovine pericardial prosthesis that is modelled on the widely implanted Perimount MagnaEase aortic prosthesis. The Perceval valve is a bovine pericardial valve attached to a self-expanding nitinol stent, which uses the radial force exerted on the patient's aortic annulus and aortic root by the stent portion to hold the valve in position. This meta-analysis compares the outcomes of comparative studies of these two valve systems.
METHODS
This systematic review and meta-analysis compares the outcomes of rapid deployment valves (RDV) and sutureless valves (SURD) and was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations and guidance. The search strategy interrogated six electronic databases. Outcomes measured included all-cause mortality at latest follow up, stroke, cross-clamp and cardiopulmonary bypass (CPB) times, pacemaker implantation rates, paravalvular leak and post-operative transvalvular gradient.
RESULTS
The search strategy identified 407 unique papers for initial assessment with seven studies qualifying for inclusion in the analysis. The outcomes of 4,076 patients (1,650 RDV, 2,426 SURD) were included. There was no difference in mortality, stroke or moderate or worse paravalvular regurgitation between the two groups. SURD had significantly shorter CPB time by 15.7 minutes [95% confidence interval (CI): 4.2-27.1; P=0.007] and a shorter cross-clamp time by 11.3 minutes (95% CI: 6.3-16.3; P<0.001) compared to RDV. RDV had a lower post-operative transvalvular gradient by 2.5 mmHg (95% CI: 1.2-3.8; P<0.001) and a lower rate of mild paravalvular regurgitation (OR 2.51; 95% CI: 1.435-4.768; P=0.004).
CONCLUSIONS
Both valve types have an adequate safety profile and are comparable to conventional sutured prostheses. There was a significant reduction in cross-clamp and CPB times associated with SURD. This may be of benefit for patients requiring multiple concomitant procedures and increases the utility of minimally invasive valve replacement. However, SURD was associated with higher post-operative transvalvular gradients and a higher incidence of paravalvular regurgitation.
PubMed: 33102175
DOI: 10.21037/acs-2020-surd-27 -
Hellenic Journal of Cardiology : HJC =... 2022The ACURATE neo transcatheter aortic valve is a self-expanding device suitable for both transfemoral and transapical approach, but specific groups of patients are... (Review)
Review
The ACURATE neo transcatheter aortic valve is a self-expanding device suitable for both transfemoral and transapical approach, but specific groups of patients are under-represented in clinical trials. We aim to provide a comprehensive systematic review on TAVI with ACURATE neo in those special populations. TAVI in bicuspid aortic valve, TAVI in patients with small aortic annulus, TAVI for pure aortic regurgitation and valve-in-valve procedures, were systematically reviewed. The primary endpoint was device success as defined by VARC-2 criteria. The secondary endpoints were safety and performance outcomes according to VARC-2 consensus document.ACURATE neo exhibited similar outcomes in bicuspid vs tricuspid aortic valve except for pre and post-dilatation rates in one observational study. Lower mean aortic gradient and higher pre-dilatation rates with comparable safety outcomes were described for ACURATE neo when compared to Lotus and Evolut-R for bicuspid aortic valve stenosis. 2 studies compared ACURATE in small aortic annuli. ACURATE neo showed lower transvalvular gradients and lower patient prosthesis mismatch rates compared to Sapien 3 and when compared to Evolut R/ Evolut PRO/ Portico, results were similar except for pre-dilatation rates. 3 studies investigated ACURATE neo for pure aortic regurgitation and one for valve-in-valve procedure and demonstrated safety and efficacy, with the exception of malposition events in patients designated for higher valve deployment in the valve-in-valve implantation study.ACURATE neo valve may be a feasible and safe option for patients with bicuspid anatomy, small aortic annulus, previously implanted bioprosthetic aortic valve and pure aortic regurgitation. REGISTRATION NUMBER: Available at https://osf.io/aus26 (DOI 10.17605/OSF.IO/AUS26).
Topics: Aortic Valve; Aortic Valve Insufficiency; Aortic Valve Stenosis; Bicuspid Aortic Valve Disease; Heart Valve Prosthesis; Humans; Observational Studies as Topic; Prosthesis Design; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 35508295
DOI: 10.1016/j.hjc.2022.04.005 -
Journal of Thrombosis and Haemostasis :... Sep 2015To perform a systematic review and meta-analysis of studies evaluating anticoagulation during the early postoperative period following mechanical heart valve... (Comparative Study)
Comparative Study Meta-Analysis Review
OBJECTIVE
To perform a systematic review and meta-analysis of studies evaluating anticoagulation during the early postoperative period following mechanical heart valve implantation.
METHODS
Five literature databases were searched to assess the rates of bleeding and thromboembolic events among patients receiving oral anticoagulation (OAC), both with and without bridging anticoagulation therapy with unfractionated heparin (UFH) or subcutaneous low molecular weight heparin (LMWH). The studies' results were pooled via a mixed effects meta-analysis. Heterogeneity (I(2) ) and publication bias were both evaluated.
RESULTS
Twenty-three studies including 9534 patients were included. The bleeding rates were 1.8% (95% confidence interval CI 1.0-3.3) in the group receiving OAC, 2.2% (95% CI 0.9-5.3) in the OAC + UFH group, and 5.5% (95% CI 2.9-10.4) in the OAC + LMWH group (P = 0.042). The thromboembolic event rate was 2.1% (95% CI 1.5-2.9) in the group receiving OAC, as compared with 1.1% (95% CI 0.7-1.8) when the bridging therapy groups were combined as follows: OAC + UFH and OAC + LMWH (P = 0.035). Most of the analyses showed moderate heterogeneity and negative test results for publication bias.
CONCLUSIONS
Bridging therapy following cardiac valve surgery was associated with a lower thromboembolic event rate, although the difference was small, with considerable overlap of the CIs. Direct comparisons are missing. Bridging therapy with UFH appears to be safe; however, this observation has a risk of bias. Early bridging therapy with LMWH appears to be associated with consistently high bleeding rates across multiple analyses. On the basis of the quality of the included studies, more trials are necessary to establish the clinical relevance of bridging therapy and the safety of LMWH.
Topics: Administration, Oral; Anticoagulants; Case-Control Studies; Cohort Studies; Equipment Design; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Hemorrhage; Heparin; Heparin, Low-Molecular-Weight; Hospital Mortality; Humans; Postoperative Complications; Postoperative Period; Publication Bias; Thromboembolism; Thrombophilia; Treatment Outcome; Warfarin
PubMed: 26178802
DOI: 10.1111/jth.13047 -
Kardiochirurgia I Torakochirurgia... Mar 2021For patients with heart valve replacement, self-management can play an essential role in the management of their condition.
INTRODUCTION
For patients with heart valve replacement, self-management can play an essential role in the management of their condition.
AIM
This review aimed to identify the aspects of self-management and its clinical outcomes in patients with heart valve replacement.
MATERIAL AND METHODS
In this systematic review, the peer-reviewed research literature on self-management of patients with heart valve replacement was assessed. Since May 2020, the PubMed, Scopus, and web of science databases were searched regardless of time and language limitations. The eligibility of the articles was assessed by title or abstract according to the search strategy. Article selection was applied regarding to inclusion and exclusion criteria. Also, article screening was conducted by 2 independent authors.
RESULTS
Twenty-five studies were considered in this systematic review. For inclusion, the self-management of patients had to have prerequisites, appropriate training, and be applicable in the aspects of anticoagulation therapy self-management, international normalized ratio (INR) self-testing, low-dose INR self-management, and heart valve function self-monitoring. In this method, through proper management of INR levels and anticoagulation therapy, the complications rate could be reduced and the patients would be able to diagnose functional disorders in the early stages by monitoring the valve function. This procedure was able to prevent the progression of complications.
CONCLUSIONS
Self-management is an applicable protocol in the field of anticoagulation therapy, INR control, low-dose INR management, and the monitoring of cardiac valve function. This protocol could improve the quality of treatment for these patients through upgrading the care standards.
PubMed: 34552643
DOI: 10.5114/kitp.2021.105186 -
Journal of Cardiothoracic Surgery Nov 2023The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve... (Review)
Review
BACKGROUND
The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve replacement. The need for consistent methodology in these early trials was highlighted by the observation of significant variability in the methods and protocols used across different research.
METHODS
An extensive search through six major databases was carried out to retrieve First-In-Human (FIH) clinical studies evaluating surgically implanted bio-prostheses in the mitral position.
RESULTS
Following the PRISMA guideline, a systematic search identified 2082 published articles until March 2023. After removing duplicates (189), 1862 citations were screened, resulting in 22 eligible studies with 3332 patients for analysis. The mitral valve prostheses in these studies ranged from 21 to 37 mm, with the 29 mm size being most prevalent. Patient numbers varied, with the FIH subgroup including 31 patients and the older subgroup including 163 patients. Average study durations differed: the older subgroup lasted 4.57 years, the FIH subgroup 2.85 years, and the early phase studies spanned 8.05 years on average.
CONCLUSION
FIH clinical report is essential to assess the significance of clinical data required for a "de novo" surgical implant. In addition, understanding the performance of the device, and recognizing the difficulties associated with the innovation constitute important lessons. These insights could be beneficial for the development of bioprosthetic heart valves and formulating a protocol for an FIH clinical trial.
Topics: Humans; Mitral Valve; Prosthesis Design; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Bioprosthesis; Prosthesis Failure
PubMed: 38037117
DOI: 10.1186/s13019-023-02464-2 -
Journal of the American Heart... Sep 2015Transcatheter aortic valve replacement (TAVR) is an effective alternative to surgical aortic valve replacement in patients at high surgical risk. However, there is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Transcatheter aortic valve replacement (TAVR) is an effective alternative to surgical aortic valve replacement in patients at high surgical risk. However, there is little published literature on the exact causes of death.
METHODS AND RESULTS
The PubMed database was systematically searched for studies reporting causes of death within and after 30 days following TAVR. Twenty-eight studies out of 3934 results retrieved were identified. In the overall analysis, 46.4% and 51.6% of deaths were related to noncardiovascular causes within and after the first 30 days, respectively. Within 30 days of TAVR, infection/sepsis (18.5%), heart failure (14.7%), and multiorgan failure (13.2%) were the top 3 causes of death. Beyond 30 days, infection/sepsis (14.3%), heart failure (14.1%), and sudden death (10.8%) were the most common causes. All possible subgroup analyses were made. No significant differences were seen for proportions of cardiovascular deaths except the comparison between moderate (mean STS score 4 to 8) and high (mean STS score >8) -risk patients after 30 days post-TAVR (56.0% versus 33.5%, P=0.005).
CONCLUSIONS
Cardiovascular and noncardiovascular causes of death are evenly balanced both in the perioperative period and at long-term follow-up after TAVR. Infection/sepsis and heart failure were the most frequent noncardiovascular and cardiovascular causes of death. This study highlights important areas of clinical focus that could further improve outcomes after TAVR.
Topics: Aortic Valve Stenosis; Cardiac Catheterization; Cause of Death; Chi-Square Distribution; Death, Sudden; Heart Failure; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Multiple Organ Failure; Prosthesis Design; Risk Assessment; Risk Factors; Sepsis; Time Factors; Treatment Outcome
PubMed: 26391132
DOI: 10.1161/JAHA.115.002096 -
International Journal of Infectious... Apr 2022We aimed to describe the clinical, microbiological, and imaging characteristics of patients with infective endocarditis (IE) in studies from Latin America (LATAM). (Review)
Review
OBJECTIVES
We aimed to describe the clinical, microbiological, and imaging characteristics of patients with infective endocarditis (IE) in studies from Latin America (LATAM).
METHODS
A systematic search through PubMed, EMBASE, LILACS, and SciELO from inception until February 2021 was conducted. We included observational studies that assessed adults with IE from LATAM and reported data on clinical, microbiological, or imaging characteristics. Data were independently extracted by 2 authors and the risk of bias was evaluated by study design with its respective tool. Findings were summarized using descriptive statistics.
RESULTS
Forty-four studies were included. Most cases were male (68.5%), had a predisposing condition including valve disease (24.3%), or had a prosthetic valve (23.4%). Clinical manifestations included fever (83.9%), malaise (63.2%), or heart murmur (57.7%). A total of 36.4% and 27.1% developed heart failure or embolism, respectively. Blood cultures were negative in 23.9% and S. aureus (18.6%) and the viridans group streptococci (17.8%) were the most common isolates. Most cases were native valve IE (67.3%) affecting mainly left-sided valves. Echocardiographic findings included vegetations (84.3%) and regurgitation (75.9%). In-hospital mortality was 25.1%.
CONCLUSIONS
This is the first systematic review that evaluated the characteristics of IE in LATAM patients. A lack of multicenter studies reflects the need for these studies in LATAM.
Topics: Adult; Echocardiography; Endocarditis; Endocarditis, Bacterial; Humans; Latin America; Male; Retrospective Studies; Staphylococcus aureus
PubMed: 35181535
DOI: 10.1016/j.ijid.2022.02.022 -
BMJ Open Apr 2018The importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in postmarket surveillance has been recognised and approved, but there is lack of... (Review)
Review
OBJECTIVES
The importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in postmarket surveillance has been recognised and approved, but there is lack of consensus standards on how to establish a CIR. The aim of this study is to investigate the structure and key elements of CIRs in the past decade (2006-2016) and to provide recommendations on 'best practice' approaches.
SETTINGS AND PARTICIPANTS
A systematic search on CIR was employed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were searched: the PubMed (Medline), ScienceDirect and the Scopus database, EMBASE. After identifying the existing CIRs, an aggregative approach will be used to explore key elements emerging in the identified registries.
RESULTS
The following 82 registries were identified: 18 implantable cardioverterdefibrillator (ICD) registries, 7 cardiac resynchronisation therapy (CRT) registries, 5 pacemaker registries and 6 cardiovascular implantable electronic device registries which combined ICD, pacemaker and CRT implantation data; as well as 22 coronary stent registries and 24 transcatheteraortic heart valve implantation registries. While 71 national or local registries are from a single country, 44 are from European countries and 9 are located in USA. The following criteria have been summarised from the identified registries, including: registry working group, ethic issues, transparency, research objective, inclusion criteria, compulsory participation, endpoint, sample size, data collection basement, data collection methods, data entry, data validation and statistical analysis.
CONCLUSIONS
Registries provide a 'real-world' picture for patients, physicians, manufacturers, payers, decision-makers and other stakeholders. CIRs are important for regulatory decisions concerning the safety and therefore approval issues of the medical device; for payers CIRs provide evidence on the medical device benefit and drive the decision whether the product should be reimbursed or not; for hospitals CIRs' data are important for sound procurement decisions, and CIRs also help patients and their physicians to joint decision-making which of the products is the most appropriate.
Topics: Cardiac Resynchronization Therapy; Coronary Disease; Defibrillators, Implantable; Europe; Heart Diseases; Heart Valve Prosthesis Implantation; Humans; Pacemaker, Artificial; Prostheses and Implants; Registries; Stents; United States
PubMed: 29654008
DOI: 10.1136/bmjopen-2017-019039