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International Journal of Cardiology Oct 2017The aim of this study was to conduct a weighted meta-analysis to determine the rates of acute (≤30days) major outcomes after (TAVR) with second-generation devices. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The aim of this study was to conduct a weighted meta-analysis to determine the rates of acute (≤30days) major outcomes after (TAVR) with second-generation devices.
METHODS
A comprehensive search of multiple electronic databases from January 2011 to May 2017 was conducted using predefined criteria. New-generation TAVR devices were defined as any device which received CE mark approval or is still under evaluation for CE marking after CoreValve and SAPIEN XT prostheses.
RESULTS
A total of 37 studies including 10,822 patients met inclusion criteria and were included in the analysis. Devices investigated in the studies were the following: SAPIEN 3 (n=5423, 45.9%), Lotus Valve (n=3007, %), Portico (n=130, 1.1%), JenaValve (n=345, 2.9%), Symetis Acurate (n=1314, 11,1%), and Evolut R (n=1603, 13.6%). Thirty-day all-cause and cardiovascular 30-day death were 2.2% (95% CI: 1.6% to 2.8%) and 1.6% (95% CI: 0.9% to 2.3%), respectively; Any stroke and major/disabling stroke occurred at a pooled estimate rate of 2.6% (95% CI: 2.0% to 3.3%) and 0.9% (95% CI: 0.2% to 1.6%), respectively; life-threatening bleeding, 3.9% (95% CI: 2.9% to 5.0%); major vascular complications, 4.5% (95% CI: 3.7% to 5.4%); pacemaker implantation, 16.2% (95% CI: 12.7% to 19.6%); more than mild aortic regurgitation, 1.6% (95% CI: 0.9 to 2.3).
CONCLUSIONS
Second-generation TAVR devices are associated with very low mortality and major complications rates at 30-day, and improved prosthesis performance with <2% of patients having more than mild post-procedural aortic regurgitation. On the other hand, the need for pacemaker implantation seems to remain an unresolved issue, and warrants further investigation.
Topics: Aortic Valve Stenosis; Heart Valve Prosthesis; Humans; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 28760396
DOI: 10.1016/j.ijcard.2017.07.083 -
European Journal of Cardio-thoracic... Jun 2022The aim of this study was to compare biological versus mechanical aortic valve replacement. (Meta-Analysis)
Meta-Analysis
OBJECTIVES
The aim of this study was to compare biological versus mechanical aortic valve replacement.
METHODS
We searched MEDLINE, Scopus and Cochrane Library databases for randomized clinical trials and propensity score-matched studies published by 14 October 2021 according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement. Individual patient data on overall survival were extracted. One- and two-stage survival analyses and random-effects meta-analyses were conducted.
RESULTS
A total of 25 studies were identified, incorporating 8721 bioprosthetic and 8962 mechanical valves. In the one-stage meta-analysis, mechanical valves cumulatively demonstrated decreased hazard for mortality [hazard ratio (HR): 0.79, 95% confidence interval (CI): 0.74-0.84, P < 0.0001]. Overall survival was similar between the compared arms for patients <50 years old (HR: 0.88, 95% CI: 0.71-1.1, P = 0.216), increased in the mechanical valve arm for patients 50-70 years old (HR: 0.76, 95% CI: 0.70-0.83, P < 0.0001) and increased in the bioprosthetic arm for patients >70 years old (HR: 1.35, 95% CI: 1.17-1.57, P < 0.0001). Meta-regression analysis revealed that the survival in the 50-70 year-old group was not influenced by the publication year of the individual studies. No statistically significant difference was observed regarding in-hospital mortality, postoperative strokes and postoperative reoperation. All-cause mortality was found decreased in the mechanical group, cardiac mortality was comparable between the 2 groups, major bleeding rates were increased in the mechanical valve group and reoperation rates were increased in the bioprosthetic valve group.
CONCLUSIONS
Survival rates seem to not be influenced by the type of prosthesis in patients <50 years old. The survival advantage in favour of mechanical valves is observed in patients 50-70 years old, while in patients >70 years old bioprosthetic valves offer better survival outcomes.
Topics: Aged; Aortic Valve; Bioprosthesis; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Middle Aged; Prosthesis Design; Retrospective Studies
PubMed: 35445694
DOI: 10.1093/ejcts/ezac268 -
Herz Apr 2021Since readmission rate is an important clinical index to determine the quality of inpatient care and hospital performance, the aim of this study was to explain the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Since readmission rate is an important clinical index to determine the quality of inpatient care and hospital performance, the aim of this study was to explain the causes and predictors of readmission following transcatheter aortic valve implantation (TAVI) at short-term and mid-term follow-up.
METHODS AND RESULTS
A systematic review and meta-analysis of all published articles from Embase, Pubmed/MEDLINE, and Ovid was carried out. In all, 10 studies including 52,702 patients were identified. The pooled estimate for the overall event rate was 0.15, and cardiovascular causes were the main reason for 30-day readmission (0.42, 95% confidence interval [CI]: 0.39-0.45). In addition, the pooled incidence of 1‑year readmission was 0.31, and cardiovascular events were still the main cause (0.41, 95% CI: 0.33-0.48). Patients with major and life-threatening bleeding, new permanent pacemaker implantation, and clinical heart failure were associated with a high risk for early readmission after TAVI. Moreover, an advanced (≥3) New York Heart Association classification, acute kidney injury, paravalvular leak, mitral regurgitation (≥ moderate), and major bleeding predicted unfavorable outcome to 1‑year readmission. Female gender and transfemoral TAVI was associated with a lower risk for unplanned rehospitalization.
CONCLUSIONS
This meta-analysis found cardiovascular factors to be the main causes for both 30-day and 1‑year rehospitalization. Heart failure represented the most common cardiovascular event at both short-term and mid-term follow-up. Several baseline characteristics and procedure-related factors were deemed unfavorable predictors of readmission. Importantly, transfemoral access and female gender were associated with a lower risk of readmission.
Topics: Aortic Valve; Aortic Valve Stenosis; Female; Heart Valve Prosthesis; Humans; Mitral Valve Insufficiency; Patient Readmission; Postoperative Complications; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 31807789
DOI: 10.1007/s00059-019-04870-6 -
Journal of the American Heart... Aug 2017Transcatheter pulmonary valve implantation is approved for the treatment of dysfunctional right ventricle to pulmonary artery conduits. However, the literature is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Transcatheter pulmonary valve implantation is approved for the treatment of dysfunctional right ventricle to pulmonary artery conduits. However, the literature is limited because of a small patient population, and it does not reflect changing procedural practice patterns over the last decade.
METHODS AND RESULTS
A comprehensive search of Medline and Scopus databases from inception through August 31, 2016 was conducted using predefined criteria. We included studies reporting transcatheter pulmonary valve implantation in at least 5 patients with a follow-up duration of 6 months or more. In 19 eligible studies, 1044 patients underwent transcatheter pulmonary valve implantation with a pooled follow-up of 2271 person-years. Procedural success rate was 96.2% (95% confidence intervals [CI], 94.6-97.4) with a conduit rupture rate of 4.1% (95% CI, 2.5-6.8) and coronary complication rate of 1.3% (95% CI, 0.7-2.3). Incidence of reintervention was 4.4 per 100 person-years overall (95% CI, 3.0-5.9) with a marked reduction in studies reporting ≥75% prestenting (2.9 per 100 person-years [95% CI, 1.5-4.3] versus 6.5/100 person-years [95% CI, 4.6-8.5]; <0.01). Pooled endocarditis rate was 1.4 per 100 person-years (95% CI, 0.9-2.0).
CONCLUSIONS
Our study provides favorable updated estimates of procedural and follow-up outcomes after transcatheter pulmonary valve implantation. Widespread adoption of prestenting has improved longer-term outcomes in these patients.
Topics: Adolescent; Adult; Cardiac Catheterization; Child; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Observational Studies as Topic; Postoperative Complications; Pulmonary Valve; Risk Factors; Time Factors; Treatment Outcome; Young Adult
PubMed: 28778940
DOI: 10.1161/JAHA.117.006432 -
Heart (British Cardiac Society) Nov 2020Current guidelines support the use of transcatheter mitral valve interventions to treat some selected high-risk patients with significant mitral valvulopathy. As with... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Current guidelines support the use of transcatheter mitral valve interventions to treat some selected high-risk patients with significant mitral valvulopathy. As with any other interventional cardiac procedure, concerns have been raised about cerebrovascular event. The aim of this systematic review and meta-analysis was to determine the incidence of cerebrovascular events following (1) transcatheter mitral valve edge-to-edge repair with mitral valve clip and (2) transcatheter mitral valve replacement (TMVR).
METHODS
We conducted a systematic review of studies reporting the cerebrovascular adverse events after transcatheter mitral valve edge-to-edge repair and TMVR procedures. The primary endpoint was the incidence of cerebrovascular events as defined by the Mitral Valve Academic Research Consortium. An event that occurred within 30 days or during index hospitalisation was defined as periprocedural; otherwise it was defined as non-periprocedural. This study was designed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Aggregated study-level data were pooled using a random effect model. The quality of each study was appraised with the Hawker checklist, a method of systematically reviewing research from different paradigms.
RESULTS
Sixty studies totalling 28 155 patients undergoing edge-to-edge repair with mitral valve clip were included in the analysis. Periprocedural stroke and non-periprocedural stroke rates were 0.9% (95% CI 0.6 to 1.1) and 2.4% (95% CI 1.6 to 3.2), respectively. For TMVR procedures, 26 studies including 1910 patients were analysed. The estimated periprocedural stroke incidence was 1% (95% CI 0.5 to 1.8) compared with 7% (95% CI 0.8 to 18.5) for non-periprocedural stroke.
CONCLUSIONS
Transcatheter mitral valve interventions are associated with low rates of cerebrovascular events. The exact mechanisms of these complications are still poorly understood given the relative paucity of good quality data.
TRIAL REGISTRATION NUMBER
CRD42019117257.
Topics: Cardiac Catheterization; Global Health; Heart Valve Prosthesis Implantation; Humans; Incidence; Mitral Valve; Mitral Valve Insufficiency; Postoperative Complications; Quality of Life; Stroke
PubMed: 32303631
DOI: 10.1136/heartjnl-2019-316331 -
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 -
Journal of Cardiac Surgery Nov 2022Postoperative acute kidney injury (AKI) and the requirement for renal replacement therapy (RRT) remain common and significant complications of both transcatheter... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Postoperative acute kidney injury (AKI) and the requirement for renal replacement therapy (RRT) remain common and significant complications of both transcatheter valve-in-valve aortic valve replacement (ViV-TAVR) and redo surgical aortic valve replacement (SAVR). Nevertheless, the understanding of renal outcomes in the population undergoing either redo SAVR or ViV-TAVR remains controversial.
METHODS
A systematic database search with meta-analysis was conducted of comparative original articles of ViV-TAVR versus redo SAVR in EMBASE, MEDLINE, Cochrane database, and Google Scholar, from inception to September 2021. Primary outcomes were AKI and RRT. Secondary outcomes were stroke, major bleeding, pacemaker implantation rate, operative mortality, and 30-day mortality.
RESULTS
Our search yielded 5435 relevant studies. Eighteen studies met the inclusion criteria with a total of 11,198 patients. We found ViV-TAVR to be associated with lower rates of AKI, postoperative RRT, major bleeding, pacemaker implantation, operative mortality, and 30-day mortality. No significant difference was observed in terms of stroke rate. The mean incidence of AKI in ViV-TAVR was 6.95% (±6%) and in redo SAVR was 15.2% (±9.6%). For RRT, our data showed that VIV-TAVR to be 1.48% (±1.46%) and redo SAVR to be 8.54% (±8.06%).
CONCLUSION
Renoprotective strategies should be put into place to prevent and reduce AKI incidence regardless of the treatment modality. Patients undergoing re-intervention for the aortic valve constitute a high-risk and frail population in which ViV-TAVR demonstrated it might be a feasible option for carefully selected patients. Long-term follow-up data and randomized control trials will be needed to evaluate mortality and morbidity outcomes between these 2 treatments.
Topics: Acute Kidney Injury; Aortic Valve; Aortic Valve Stenosis; Heart Valve Prosthesis Implantation; Humans; Reoperation; Risk Factors; Stroke; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 36040611
DOI: 10.1111/jocs.16890 -
Current Problems in Cardiology Mar 2021To compare outcomes of mitral valve surgery through conventional left atriotomy and transeptal approach (TS). Preferred Reporting Items for Systematic Reviews and... (Meta-Analysis)
Meta-Analysis Review
To compare outcomes of mitral valve surgery through conventional left atriotomy and transeptal approach (TS). Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Primary outcomes were operative mortality and permanent pacemaker (PPM) implantation; secondary outcomes were new onset of atrial fibrillation (AF), stroke and operative times. Sixteen articles met the inclusion criteria with 4537 patients. Cardiopulmonary bypass was longer with TS (weighted mean differences - 16.44 minutes [-29.53, -3.36], P = 0.01). Rates of PPM implantation (risk ratio 0.65 [0.47, 0.89], P = 0.007) and new onset AF (risk ratio 0.87 [0.78, 0.97], P = 0.02) were higher with TS. Subgroup analysis of isolated mitral valve surgery cohort showed no difference in operative times, mortality, new onset of AF, stroke, and PPM implantation. There is equal outcomes between both approaches during isolated mitral valve surgery; however, TS was associated with longer operative times and higher postoperative AF and PPM rates when pooling combined procedures. A large randomized controlled trial is required to confirm those findings.
Topics: Atrial Fibrillation; Cardiac Surgical Procedures; Heart Atria; Heart Valve Diseases; Heart Valve Prosthesis Implantation; Humans; Mitral Valve; Treatment Outcome
PubMed: 32532451
DOI: 10.1016/j.cpcardiol.2020.100602 -
The Journal of Thoracic and... Nov 2021Recent high-resolution computed tomography studies after transcatheter aortic valve insertion (TAVI) have reported a high prevalence of subclinical valve thrombosis... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Recent high-resolution computed tomography studies after transcatheter aortic valve insertion (TAVI) have reported a high prevalence of subclinical valve thrombosis (SCVT), potentially contributing to increased risk of late stroke. We aimed to investigate SCVT in patients after TAVI, with a focus on prevalence, predisposing factors, management, and potential sequelae.
METHODS
A comprehensive literature review of patients with SCVT after TAVI was carried out on all published studies in 3 major electronic databases from their inception until October 2019. Studies with sufficient data were included in a meta-analysis comparing the risk of stroke between patients with SCVT and those with normal valve function, as well as the protective effects of antiplatelet and anticoagulation on preventing SCVT.
RESULTS
From 3456 patients examined in a comprehensive review, 398 patients (11.5%) demonstrated evidence of SCVT during follow-up. Dual antiplatelet therapy was given in 45.5% of cases, single antiplatelet therapy in 19.8%, and oral anticoagulation in 28.5%. A meta-analysis demonstrated that rates of stroke were more than 3 times greater in patients with SCVT compared with those without (logistic odds, 1.10; 95% confidence interval, 0.63-1.57, P < .0001). Oral anticoagulation was superior to dual antiplatelet therapy or single antiplatelet therapy, preventing the formation of SCVT (logistic odds, -1.05, 95% confidence interval, -1.71 to -0.39, P < .0001).
CONCLUSIONS
Subclinical valve thrombosis is seen in 11.5% of patients after TAVI and is associated with increased risk of stroke. When oral anticoagulation is used postprocedurally, it is more effective than either dual or single-antiplatelet therapy in preventing subclinical valve thrombosis. These findings suggest that further studies are needed to define the optimal antithrombotic regimen to mitigate thrombotic and embolic sequelae after TAVI.
Topics: Aged; Aged, 80 and over; Anticoagulants; Aortic Valve; Asymptomatic Diseases; Female; Fibrinolytic Agents; Heart Valve Prosthesis; Humans; Male; Middle Aged; Platelet Aggregation Inhibitors; Risk Assessment; Risk Factors; Stroke; Thrombosis; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 32217021
DOI: 10.1016/j.jtcvs.2020.01.084 -
American Heart Journal Jul 2023The use of F-FDG PET/CT in diagnostic algorithms for PVE has increased since publication of studies and guidelines advocating its use. The assessment of test accuracy... (Meta-Analysis)
Meta-Analysis Review
IMPORTANCE
The use of F-FDG PET/CT in diagnostic algorithms for PVE has increased since publication of studies and guidelines advocating its use. The assessment of test accuracy has been limited by small study sizes. We undertook a systematic review using individual patient data (IPD) meta-analysis techniques.
OBJECTIVE
To estimate the summary sensitivity and specificity of F-FDG PET/CT in diagnosing PVE. We also assessed the effect of patient factors on test accuracy as defined by changes in the odds ratios associated with each factor. The effect of the PET/CT study on the final diagnosis was also assessed when compared to the preliminary Duke classification to determine in which patient group F-FDG PET/CT had the greatest utility.
STUDY SELECTION
Studies were included if PET/CT was performed for suspicion of PVE and IPD of both the PET/CT result and final diagnosis defined by a gold-standard assessment was available. There were 3 possible final diagnoses ("definite PVE," "possible PVE," and "rejected PVE").
RESULTS
Seventeen studies were included with IPD available for 537 patients (from 538 scans). The summary sensitivity and specificity were 85% (95% CI 74.2%-91.8%) and 86.5% (95% CI 75.8%-92.9%) respectively when patients with final diagnosis of "possible PVE" were classified as positive for PVE. When this group was classified as negative for PVE, sensitivity was 87.4% (95% CI 80.4%-92.1%) and specificity was 84.9% (95% CI 71.5%-92.6%). Patients with a known pathogen (especially coagulase negative staphylococcal species), elevated CRP, a biological or aortic valve infection appeared more likely to have an accurate PET/CT diagnosis. Those with a mechanical valve, prior antibiotic treatment or a transcatheter aortic valve replacement valve were less likely to have an accurate test. Time since valve implantation and the presence of surgical adhesive did not appear to affect test accuracy. Of the patients with a preliminary Duke classification of "possible PVE," 84% received a more conclusive final diagnosis of "definite" or "rejected" PVE after the PET/CT study.
CONCLUSIONS AND RELEVANCE
F-FDG PET/CT has high sensitivity and specificity in diagnosing PVE and the diagnostic utility is greatest in patients with a preliminary Duke classification of "possible PVE." Some patient factors appear to affect test accuracy, though these results should be interpreted with caution given low patient numbers for subgroup analyses.
Topics: Humans; Positron Emission Tomography Computed Tomography; Fluorodeoxyglucose F18; Endocarditis, Bacterial; Heart Valve Prosthesis; Endocarditis; Sensitivity and Specificity; Radiopharmaceuticals
PubMed: 36934977
DOI: 10.1016/j.ahj.2023.03.004