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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 -
Medical Sciences (Basel, Switzerland) May 2023Previous studies have demonstrated gender disparities in mortality and vascular complications after transcatheter aortic valve replacement (TAVR) with early generation... (Meta-Analysis)
Meta-Analysis Review
Previous studies have demonstrated gender disparities in mortality and vascular complications after transcatheter aortic valve replacement (TAVR) with early generation transcatheter heart valves (THVs). It is unclear, however, whether gender-related differences persist with the newer generation THVs. We aim to assess gender disparities after TAVR with newer generation THVs. The MEDLINE and Embase databases were thoroughly searched from inception to April 2023 to identify studies that reported gender-specific outcomes after TAVR with newer generation THVs (Sapien 3, Corevalve Evolut R, and Evolut Pro). The outcomes of interest included 30-day mortality, 1-year mortality, and vascular complications. In total, 5 studies (4 databases) with a total of 47,933 patients (21,073 females and 26,860 males) were included. Ninety-six percent received TAVR via the transfemoral approach. The females had higher 30-day mortality rates (odds ratio (OR) = 1.53, 95% confidence interval (CI) 1.31-1.79, -value () < 0.001) and vascular complications (OR = 1.43, 95% CI 1.23-1.65, < 0.001). However, one-year mortality was similar between the two groups (OR = 0.78, 95% CI 0.61-1.00, = 0.28). The female gender continues to be associated with higher 30-day mortality rates and vascular complications after TAVR with newer generation transcatheter heart valves, while there was no difference in 1-year mortality between the genders. More data is needed to explore the causes and whether we can improve TAVR outcomes in females.
Topics: Humans; Female; Male; Transcatheter Aortic Valve Replacement; Aortic Valve; Aortic Valve Stenosis; Treatment Outcome; Risk Factors; Heart Valve Prosthesis
PubMed: 37218985
DOI: 10.3390/medsci11020033 -
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 -
Frontiers in Cardiovascular Medicine 2022Patient-prosthesis mismatch (PPM) remains one out of many factors to be considered during decision-making for the treatment of aortic valve pathologies. The idea of...
Patient-prosthesis mismatch (PPM) remains one out of many factors to be considered during decision-making for the treatment of aortic valve pathologies. The idea of adequate sizing of a prosthetic heart valve was established by Rahimtoola already in 1978. In this article, the author described the phenomenon that the orifice area of a prosthetic heart valve may be too small for the individual patient. PPM is assessed by measurement or projection of the prosthetic effective orifice area indexed to body surface area (iEOA), while it is recommended to use different cut point values for non-obese and obese patients for the categorization of moderate and severe PPM. Several factors influence the accuracy of both the projected and the measured iEOA for PPM assessment, which leads to a certain number of false assignments to the PPM or no PPM group. Despite divergent findings on the impact of PPM on clinical outcomes, there is consensus that PPM should be avoided to prevent sequelae of increased prosthetic gradients after aortic valve replacement. To prevent PPM, it is required to anticipate the iEOA of the prosthesis prior to the procedure. The use of adequate reference tables, derived from echocardiographically measured mean effective orifice area (EOA) values from preferably large numbers of patients, is most appropriate to predict the iEOA. Such tables should be used also for transcatheter heart valves in the future. During the decision-making process, all available options should be taken into account for the individual patient. If the predicted size and type of a surgical prosthesis cannot be implanted, additional surgical procedures, such as annular enlargement with the Manougian technique, or alternative procedures, such as transcatheter aortic valve implantation (TAVI) can prevent PPM. PPM prevention for TAVI patients is a new field of interest and includes anticipation of the iEOA, prosthesis selection, and procedural strategies.
PubMed: 35433878
DOI: 10.3389/fcvm.2022.761917 -
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 -
European Radiology Jul 2015Multimodal non-invasive imaging plays a key role in establishing a diagnosis of PHV endocarditis. The objective of this study was to provide a systematic review of the... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
Multimodal non-invasive imaging plays a key role in establishing a diagnosis of PHV endocarditis. The objective of this study was to provide a systematic review of the literature and meta-analysis of the diagnostic accuracy of TTE, TEE, and MDCT in patients with (suspected) PHV endocarditis.
METHODS
Studies published between 1985 and 2013 were identified via search and cross-reference of PubMed/Embase databases. Studies were included if (1) they reported on the non-invasive index tests TTE, TEE, or MDCT; (2) data was provided on PHV endocarditis as the condition of interest; and (3) imaging results were verified against either surgical inspection/autopsy or clinical follow-up reference standards, thereby enabling the extraction of 2-by-2 tables.
RESULTS
Twenty articles (including 496 patients) met the inclusion criteria for PHV endocarditis. TTE, TEE, and MDCT + TEE had a pooled sensitivity/specificity for vegetations of 29/100%; 82/95%, and 88/94%, respectively. The pooled sensitivity/specificity of TTE, TEE, and MDCT + TEE for periannular complications was 36/93%, 86/98%, and 100/94%, respectively.
CONCLUSIONS
TEE showed good sensitivity and specificity for establishing a diagnosis of PHV endocarditis. Although MDCT data are limited, this review showed that MDCT in addition to TEE may improve sensitivity in detecting life-threatening periannular complications.
KEY POINTS
• Multimodal imaging is an important ingredient of diagnostic workup for PHV endocarditis. • Transthoracic and transesophageal echography may miss life-threatening periannular complications. • MDCT can improve sensitivity for the detection of life-threatening periannular complications.
Topics: Diagnosis, Differential; Echocardiography; Echocardiography, Transesophageal; Endocarditis; Heart Valve Prosthesis; Humans; Multidetector Computed Tomography; Multimodal Imaging; Prosthesis-Related Infections; Sensitivity and Specificity
PubMed: 25680715
DOI: 10.1007/s00330-015-3605-7 -
European Heart Journal Sep 2023To support decision-making in children undergoing aortic valve replacement (AVR), by providing a comprehensive overview of published outcomes after paediatric AVR, and... (Meta-Analysis)
Meta-Analysis
AIMS
To support decision-making in children undergoing aortic valve replacement (AVR), by providing a comprehensive overview of published outcomes after paediatric AVR, and microsimulation-based age-specific estimates of outcome with different valve substitutes.
METHODS AND RESULTS
A systematic review of published literature reporting clinical outcome after paediatric AVR (mean age <18 years) published between 1/1/1990 and 11/08/2021 was conducted. Publications reporting outcome after paediatric Ross procedure, mechanical AVR (mAVR), homograft AVR (hAVR), and/or bioprosthetic AVR were considered for inclusion. Early risks (<30d), late event rates (>30d) and time-to-event data were pooled and entered into a microsimulation model. Sixty-eight studies, of which one prospective and 67 retrospective cohort studies, were included, encompassing a total of 5259 patients (37 435 patient-years; median follow-up: 5.9 years; range 1-21 years). Pooled mean age for the Ross procedure, mAVR, and hAVR was 9.2 ± 5.6, 13.0 ± 3.4, and 8.4 ± 5.4 years, respectively. Pooled early mortality for the Ross procedure, mAVR, and hAVR was 3.7% (95% CI, 3.0%-4.7%), 7.0% (5.1%-9.6%), and 10.6% (6.6%-17.0%), respectively, and late mortality rate was 0.5%/year (0.4%-0.7%/year), 1.0%/year (0.6%-1.5%/year), and 1.4%/year (0.8%-2.5%/year), respectively. Microsimulation-based mean life-expectancy in the first 20 years was 18.9 years (18.6-19.1 years) after Ross (relative life-expectancy: 94.8%) and 17.0 years (16.5-17.6 years) after mAVR (relative life-expectancy: 86.3%). Microsimulation-based 20-year risk of aortic valve reintervention was 42.0% (95% CI: 39.6%-44.6%) after Ross and 17.8% (95% CI: 17.0%-19.4%) after mAVR.
CONCLUSION
Results of paediatric AVR are currently suboptimal with substantial mortality especially in the very young with considerable reintervention hazards for all valve substitutes, but the Ross procedure provides a survival benefit over mAVR. Pros and cons of substitutes should be carefully weighed during paediatric valve selection.
Topics: Humans; Child; Adolescent; Aortic Valve; Heart Valve Prosthesis Implantation; Retrospective Studies; Prospective Studies; Heart Valve Prosthesis; Treatment Outcome
PubMed: 37366156
DOI: 10.1093/eurheartj/ehad370 -
Arquivos Brasileiros de Cardiologia Mar 2019The choice of a mechanical (MP) or biological prosthesis (BP) for patients with valvular heart disease undergoing replacement is still not a consensus. (Meta-Analysis)
Meta-Analysis
BACKGROUND
The choice of a mechanical (MP) or biological prosthesis (BP) for patients with valvular heart disease undergoing replacement is still not a consensus.
OBJECTIVE
We aimed to determine the clinical outcomes of MP or BP placement in those patients.
METHODS
We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) that compared biological prostheses and mechanical prostheses in patients with valvular heart diseases and assessed the outcomes. RCTs were searched in the MEDLINE, EMBASE, LILACS, CENTRAL, SCOPUS and Web of Science (from inception to November 2014) databases. Meta-analyses were performed using inverse variance with random effects models. The GRADE system was used to rate the quality of the evidence. A P-value lower than 0.05 was considered significant.
RESULTS
A total of four RCTs were included in the meta-analyses (1,528 patients) with follow up ranging from 2 to 20 years. Three used old generation mechanical and biological prostheses, and one used contemporary prostheses. No significant difference in mortality was found between BP and MP patients (risk ratio (RR = 1.07; 95% CI 0.99-1.15). The risk of bleeding was significantly lower in BP patients than MP patients (RR = 0.64; 95% CI 0.52-0.78); however, reoperations were significantly more frequent in BP patients (RR = 3.60; 95% CI 2.44-5.32). There were no statistically significant differences between BP and MP patients with respect to systemic arterial embolisms and infective endocarditis (RR = 0.93; 95% CI 0.66-1.31, RR = 1.21; CI95% 0.78-1.88, respectively). Results in the trials with modern and old prostheses were similar.
CONCLUSIONS
The mortality rate and the risk of thromboembolic events and endocarditis were similar between BP and MP patients. The risk of bleeding was approximately one third lower for BP patients than for MP patients, while the risk of reoperations was more than three times higher for BP patients.
Topics: Bioprosthesis; Evidence-Based Medicine; Heart Valve Diseases; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Randomized Controlled Trials as Topic; Reoperation; Treatment Outcome
PubMed: 30916201
DOI: 10.5935/abc.20180272 -
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