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Journal of Cardiac Surgery Aug 2016Valve selection in patients with end-stage renal disease (ESRD) is uncertain. We performed a systematic review and meta-analysis to compare clinical outcome in ESRD... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Valve selection in patients with end-stage renal disease (ESRD) is uncertain. We performed a systematic review and meta-analysis to compare clinical outcome in ESRD patients undergoing valve replacement.
METHODS
We systematically searched multiple databases (2000-October 2015) to identify original studies comparing adverse events between mechanical and biological valve replacement in ESRD patients. End-points studied were: postoperative mortality, bleeding events, need for re-operation, and late survival. A random-effect inverse-variance weighted analysis was performed; event rates are compared as odds ratio (OR and 95% confidence interval) and hazard ratios (HR) for time-to-event data. Mechanical valve and tissue valve replacement were considered as study and control cohorts, respectively.
RESULTS
Fifteen retrospective studies (5523 mechanical and 1600 tissue valve) were included in our meta-analysis. Early mortality was comparable (OR 1.15 [0.77; 1.72]; p = 0.49). The mean follow-up among studies ranged from 1.6-15 years. Bleeding was significantly higher after mechanical valve replacement (OR 2.55 [1.53; 4.26]; p = 0.0003). Structural valve degeneration was present in only 0.6% patients after a tissue valve replacement. Overall survival after valve replacement was poor (median 2.61 years); valve choice did not influence this outcome (pooled HR 0.87 [0.73; 1.04]; p = 0.14).
CONCLUSION
Operative mortality in ESRD patients is comparable between mechanical and tissue valve replacement. Major bleeding episodes are significantly higher after mechanical valve replacement but structural degeneration in tissue valves during the follow-up period is low. Based on the findings from this meta-analysis, we would recommend using tissue valves in patients with ESRD.
Topics: Bioprosthesis; Heart Valve Diseases; Heart Valve Prosthesis; Heart Valves; Humans; Kidney Failure, Chronic; Prosthesis Design; Retrospective Studies
PubMed: 27389823
DOI: 10.1111/jocs.12805 -
Acta Cardiologica Sep 2023Transcatheter aortic valve implantation (TAVI) has been established as a reasonable alternative to surgical aortic valve replacement (SAVR) in patients with severe... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Transcatheter aortic valve implantation (TAVI) has been established as a reasonable alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis. However, long-term outcomes including valve durability and the need for reintervention are unanswered, especially in younger patients who tend to be low surgical risk. We performed a meta-analysis comparing clinical outcomes after TAVI and SAVR over 5 years stratified to low, intermediate, and high surgical risks.
METHODS
We identified propensity score-matched observational studies and randomised controlled trials comparing TAVI and SAVR. Primary outcomes, including all-cause mortality, moderate or severe aortic regurgitation, moderate or severe paravalvular regurgitation, pacemaker placement, and stroke, were extracted. Meta-analyses of outcomes after TAVI compared to SAVR were conducted for different periods of follow-up. Meta-regression was also performed to analyse the correlation of outcomes over time.
RESULTS
A total of 36 studies consisting of 7 RCTs and 29 propensity score-matched studies were selected. TAVI was associated with higher all-cause mortality at 4-5 years in patients with low or intermediate surgical risk. Meta-regression time demonstrated an increasing trend in the risk of all-cause mortality after TAVI compared with SAVR. TAVI was generally associated with a higher risk of moderate or severe aortic regurgitation, moderate or severe paravalvular regurgitation, and pacemaker placement.
CONCLUSIONS
TAVI demonstrated an increasing trend of all-cause mortality compared with SAVR when evaluated over a long-term follow-up. More long-term data from recent studies using newer-generation valves and state-of-the-art techniques are needed to accurately assign risks.
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve; Heart Valve Prosthesis Implantation; Aortic Valve Insufficiency; Aortic Valve Stenosis; Risk Factors; Treatment Outcome
PubMed: 37294002
DOI: 10.1080/00015385.2023.2218025 -
Archives of Cardiovascular Diseases Dec 2023Leaflet thrombosis and reduced leaflet motion have become a concern with the expanding use of transcatheter aortic valve replacement in lower-risk patients. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Leaflet thrombosis and reduced leaflet motion have become a concern with the expanding use of transcatheter aortic valve replacement in lower-risk patients.
AIMS
To assess the proportions, predictors and clinical impact of leaflet thrombosis and reduced leaflet motion after transcatheter aortic valve replacement.
METHODS
We performed a meta-analysis of studies assessing the proportions of and/or clinical outcomes according to the presence of leaflet thrombosis after transcatheter aortic valve replacement identified with computed tomography and/or echocardiography.
RESULTS
Fifty-three studies, representing 25,258 patients undergoing transcatheter aortic valve replacement, were considered. The proportion of leaflet thrombosis was 5.2% overall, and was higher in computed tomography versus echocardiography (16.4% vs. 1.1%, respectively); reduced leaflet motion was identified in 11% of patients with four-dimensional computed tomography. Intra-annular bioprostheses were associated with a higher proportion of leaflet thrombosis, whereas chronic oral anticoagulation was protective for leaflet thrombosis in both computed tomography and echocardiographic studies (9.7% vs. 17.5%; relative risk [RR]: 0.51, 95% confidence interval [95% CI]: 0.37-0.71 and 0.9% vs. 2.7%; RR: 0.22, 95% CI: 0.06-0.79, respectively) and for reduced leaflet motion (2.5% vs. 12.4%; RR: 0.32, 95% CI: 0.13-0.76). Leaflet thrombosis was not associated with an increased risk of death, but with a higher risk of stroke in computed tomography studies (2.8% vs. 2.4%; RR: 1.63, 95% CI: 1.05-2.55), a difference more pronounced when considering reduced leaflet motion (3.5% vs. 1.7%; RR: 2.39, 95% CI: 0.63-8.34).
CONCLUSIONS
The proportion of leaflet thrombosis is highly variable according to the screening approach, the type of valve and the use of oral anticoagulation. The occurrence of cerebral events is increased when leaflet thrombosis and/or reduced leaflet motion are diagnosed, but leaflet thrombosis has no impact on survival.
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve; Heart Valve Prosthesis; Thrombosis; Anticoagulants; Aortic Valve Stenosis; Treatment Outcome
PubMed: 37968182
DOI: 10.1016/j.acvd.2023.10.003 -
Journal of Cardiac Surgery Dec 2022To highlight short- and long-term clinical outcomes of the Intuity TM rapid deployment prosthesis for surgical aortic valve replacement. (Review)
Review
OBJECTIVES
To highlight short- and long-term clinical outcomes of the Intuity TM rapid deployment prosthesis for surgical aortic valve replacement.
METHODS
We reviewed on PubMed/MEDLINE, Embase, SciELO, LILACS, CCTR/CENTRAL, and Google Scholar for clinical trials, retrospective clinical studies, meta-analysis, and gray literature.
RESULTS
Fourty-five clinical studies with 12.714 patients were included in the analysis. Thirty-day mortality ranged from 3.8% for Intuity and 3.9% for transcatheter aortic valve replacement (TAVR). The incidence of paravalvular leak (PVL) (Intuity 0% and TAVR 2.17%), permanent pacemaker implantation (Intuity 11.11% and TAVR 12.5%), stroke (Intuity 2.2% and TAVR 2.6%), myocardial infarction (MI) (Intuity 0% and TAVR 1%), were all higher in the TAVR group. Compared to other sutured bioprosthesis (SB), mortality ranged from 0% to 3.9% for Intuity and 0%-6.9% for SB. Long-term cardiac mortality ranged from 0.9% to 1.55% for Intuity and 1.4%-3.3% for the Perceval valve. The incidence of PVL (Intuity 0.24%-0.7% and Perceval 0%-1%), endocarditis (Intuity 0.2%-0.7% and Perceval 1.6%-6.6%), stroke (Intuity 0.36%-1.4% and Perceval 0%-0.8%), MI (Intuity 0.07%-0.26%), and SVD (Intuity 0.12%-0.7% and Perceval 0%) were comparable. Compared to standard full sternotomy (SFS), minimally invasive surgery (MINV) mortality ranged from 0% to 4.3% for MINV and 0%-2.1% for SFS. Hospital costs outcomes ranged from $37,187-$44,368 for the Intuity, $69,389 for TAVR, and $13,543 for SB. Intuity short-term mortality ranged between 0.9% and 12.4% while long-term mortality ranged between 2.6% and 20%.
CONCLUSIONS
This manuscript provides a 360° overview of the current rapid deployments, sutureless, and TAVR prosthesis.
Topics: Humans; Aortic Valve; Aortic Valve Stenosis; Bioprosthesis; Heart Valve Prosthesis; Prosthesis Design; Retrospective Studies; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 36403259
DOI: 10.1111/jocs.17231 -
Cardiovascular Revascularization... Sep 2022
Meta-Analysis
Commentary on the Prognostic Impact of Pre- and Post-Procedural Renal Dysfunction on Late All-Cause Mortality Outcome Following Transcatheter Edge-to-Edge Repair of the Mitral Valve: A Systematic Review and Meta-Analysis.
Topics: Heart Valve Prosthesis Implantation; Humans; Kidney Diseases; Mitral Valve; Mitral Valve Insufficiency; Prognosis
PubMed: 35811241
DOI: 10.1016/j.carrev.2022.04.022 -
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 -
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 -
Catheterization and Cardiovascular... Feb 2016The role of right ventricular outflow tract (RVOT) prestenting in the prevention of Melody valve stent fractures (SFs) is not well defined. We aimed to perform a... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
The role of right ventricular outflow tract (RVOT) prestenting in the prevention of Melody valve stent fractures (SFs) is not well defined. We aimed to perform a systematic review and meta-analysis comparing the incidence of SF in Melody valve transcatheter pulmonary implants with and without prestenting.
METHODS
PubMed, EMBASE, and Cochrane Central were searched for studies that reported the incidence of SF in Melody valve transcatheter pulmonary implants stratified by the presence or absence of RVOT prestenting. Subgroup analyses were performed for (1) SF associated with a loss of stent integrity and (2) SF requiring reintervention.
RESULTS
Five studies and 360 patients were included, of whom 207 (57.5%) received prestenting. Follow-up ranged from 15 to 30 months. SF were significantly reduced in the prestenting group (16.7%) when compared to no prestenting (33.5%) (odds-ratio [OR] 0.39; 95%CI 0.22-0.69). Patients who received prestenting also had a lower incidence of (1) SF associated with loss of stent integrity (OR 0.16; 95%CI 0.05-0.48) and (2) SF requiring reintervention (OR 0.15; 95%CI 0.02-0.91).
CONCLUSION
Our findings suggest that stenting of the RVOT prior to Melody valve implantation is associated with a reduction in the incidence of SF and fracture-related reinterventions.
Topics: Adolescent; Adult; Aged; Angioplasty, Balloon; Cardiac Catheterization; Chi-Square Distribution; Child; Child, Preschool; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Male; Middle Aged; Odds Ratio; Prosthesis Design; Prosthesis Failure; Pulmonary Valve; Risk Assessment; Risk Factors; Stents; Treatment Outcome; Young Adult
PubMed: 26481871
DOI: 10.1002/ccd.26235 -
Interventional Cardiology Clinics Jul 2017Valvular heart diseases such as aortic stenosis and mitral regurgitation are often associated with heart failure, which in turn increases patients' Surgical Thoracic...
Valvular heart diseases such as aortic stenosis and mitral regurgitation are often associated with heart failure, which in turn increases patients' Surgical Thoracic Society (STS) score. A high STS score means the patient is high risk for surgical aortic valve replacement and mitral valve repair/replacement. Transcatheter aortic valve replacement and percutaneous mitral valve repair offer a minimally invasive alternative for the treatment of valvular heart disease in patients with severe heart failure. We aim to review the current evidence on the safety, efficacy, and outcomes of these devices in patients with severe heart failure.
Topics: Aortic Valve; Heart Failure; Heart Valve Prosthesis; Humans; Prosthesis Design; Transcatheter Aortic Valve Replacement
PubMed: 28600091
DOI: 10.1016/j.iccl.2017.03.007 -
The Journal of Invasive Cardiology Nov 2023Transcatheter edge-to-edge repair (TEER) using the MitraClip (Abbott Vascular) system has emerged as a standard treatment for patients with symptomatic severe secondary... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Transcatheter edge-to-edge repair (TEER) using the MitraClip (Abbott Vascular) system has emerged as a standard treatment for patients with symptomatic severe secondary or inoperable primary mitral regurgitation (MR). The relatively recent approval of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences) has expanded the options of TEER devices. However, evidence comparing PASCAL with MitraClip systems is still limited.
METHODS
We conducted a systematic literature research and meta-analysis in PubMed, Medline, and EMBASE databases for studies comparing PASCAL and MitraClip systems.
RESULTS
Four observational studies and 1 randomized controlled trial, involving 1315 patients total, were eligible for inclusion. All patients exhibited symptomatic (NYHA II-IV) MR grades 3+ or 4+. Baseline characteristics were comparable across all included studies. The clinical outcomes were assessed according to the Mitral Valve Academic Research Consortium consensus. The procedural success rates for the 2 devices were comparable in terms of achieving post-procedural MR grades of less than or equal to 2+ and less than or equal to 1+. Furthermore, most patients improved their clinical status, with no significant differences between patients treated with PASCAL and those treated with MitraClip. In terms of safety, both procedures exhibited low overall mortality rates and occurrence of major adverse events (MAE), without significant difference between the 2 devices. These findings remained consistent in both short- and long-term follow-up assessments.
CONCLUSIONS
Our study revealed similar effectiveness and safety profiles between the PASCAL and MitraClip devices in patients experiencing significant symptomatic MR.
Topics: Humans; Cardiac Catheterization; Cardiac Surgical Procedures; Catheters; Heart Valve Prosthesis Implantation; Mitral Valve; Mitral Valve Insufficiency; Treatment Outcome
PubMed: 37992330
DOI: 10.25270/jic/23.00218