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Catheterization and Cardiovascular... Nov 2020We performed a systematic review and meta-analysis to evaluate the early and midterm outcomes of patients who underwent surgical aortic valve replacement (SAVR) and... (Meta-Analysis)
Meta-Analysis
Transcatheter aortic valve replacement and percutaneous coronary intervention versus surgical aortic valve replacement and coronary artery bypass grafting in patients with severe aortic stenosis and concomitant coronary artery disease: A systematic review and meta-analysis.
OBJECTIVES
We performed a systematic review and meta-analysis to evaluate the early and midterm outcomes of patients who underwent surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) against patients who had transcatheter aortic valve replacement (TAVR) and percutaneous coronary intervention (PCI).
BACKGROUND
Contemporary guidelines suggest that surgical or percutaneous revascularization of significant coronary artery disease (CAD) in patients with severe aortic stenosis (AS) is a reasonable strategy.
METHODS
We conducted a comprehensive search of Medline and Embase to identify studies comparing a percutaneous transcatheter versus a surgical approach. Random effects meta-analyses using the Mantel-Haenszel method were performed to estimate the effect of percutaneous compared surgical strategies using aggregate data.
RESULTS
Six studies reporting on 1770 participants were included in the meta-analysis. There were no significant differences in effect estimates for early and midterm mortality (OR: 0.78; 95% CI, 0.50-1.20 and OR: 1.09; 95% CI, 0.80-1.49, respectively) or myocardial infarction (OR: 0.52; 95% CI, 0.20-1.33 and OR: 1.34; 95% CI, 0.67-2.65, respectively). No significant difference was shown for peri-procedural stroke (OR: 0.80; 95% CI, 0.35-1.87). A transcatheter approach had a higher rate of major vascular complications (OR: 14.44; 95% CI, 4.42-47.16), but a lower rate of acute kidney injury (OR: 0.41; 95% CI, 0.19-0.91).
CONCLUSION
Our analysis suggests that a percutaneous transcatheter approach confers similar outcomes compared to a surgical approach in patients with severe AS and CAD. However, our findings are based on low quality studies and should serve as hypothesis generating. In the absence of adequately powered studies yielding high level evidence, individualized decision making should be based on surgical risk assessment.
Topics: Aged; Aged, 80 and over; Aortic Valve; Aortic Valve Stenosis; Coronary Artery Bypass; Coronary Artery Disease; Female; Humans; Male; Postoperative Complications; Risk Assessment; Risk Factors; Severity of Illness Index; Time Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 32662594
DOI: 10.1002/ccd.29110 -
Cardiology 2020Mitral regurgitation (MR) is commonly encountered in patients with severe aortic stenosis (AS). However, its independent impact on mortality in patients undergoing... (Meta-Analysis)
Meta-Analysis
Does the Presence of Significant Mitral Regurgitation prior to Transcatheter Aortic Valve Implantation for Aortic Stenosis Impact Mortality? - Meta-Analysis and Systematic Review.
BACKGROUND
Mitral regurgitation (MR) is commonly encountered in patients with severe aortic stenosis (AS). However, its independent impact on mortality in patients undergoing transcatheter aortic valve implantation (TAVI) has not been established.
METHODS
We performed a systematic search for studies reporting characteristics and outcome of patients with and without significant MR and/or adjusted mortality associated with MR post-TAVI. We conducted a meta-analysis of quantitative data.
RESULTS
Seventeen studies with 20,717 patients compared outcomes and group characteristics. Twenty-one studies with 32,257 patients reported adjusted odds of mortality associated with MR. Patients with MR were older, had a higher Society of Thoracic Surgeons score, lower left ventricular ejection fraction, a higher incidence of prior myocardial infarction, atrial fibrillation, and a trend towards higher NYHA class III/IV, but had similar mean gradient, gender, and chronic kidney disease. The MR patients had a higher unadjusted short-term (RR = 1.46, 95% CI 1.30-1.65) and long-term mortality (RR = 1.40, 95% CI 1.18-1.65). However, 16 of 21 studies with 27,777 patients found no association between MR and mortality after adjusting for baseline variables. In greater than half of the patients (0.56, 95% CI 0.45-0.66) MR improved by at least one grade following TAVI.
CONCLUSION
The patients with MR undergoing TAVI have a higher burden of risk factors which can independently impact mortality. There is a lack of robust evidence supporting an increased mortality in MR patients, after adjusting for other compounding variables. MR tends to improve in the majority of patients post-TAVI.
Topics: Aortic Valve Stenosis; Cardiac Catheterization; Cause of Death; Humans; Incidence; Mitral Valve Insufficiency; Risk Assessment; Risk Factors; Severity of Illness Index; Time Factors; Transcatheter Aortic Valve Replacement
PubMed: 32460301
DOI: 10.1159/000506624 -
Clinical Cardiology Dec 2020Transcatheter aortic valve replacement (TAVR) is regarded as the most superior alternative treatment approach for patients with aortic stenosis (AS) who are associated... (Meta-Analysis)
Meta-Analysis
Transcatheter vs surgical aortic valve replacement in low to intermediate surgical risk aortic stenosis patients: A systematic review and meta-analysis of randomized controlled trials.
BACKGROUND
Transcatheter aortic valve replacement (TAVR) is regarded as the most superior alternative treatment approach for patients with aortic stenosis (AS) who are associated with high surgical risk, whereas the effectiveness of TAVR vs surgical aortic valve replacement (SAVR) in low to intermediate surgical risk patients remained inconclusive. This study aimed to determine the best treatment strategies for AS with low to intermediate surgical risk based on published randomized controlled trials (RCTs).
HYPOTHESIS AND METHODS
RCTs that compared TAVR vs SAVR in AS patients with low to intermediate surgical risk were identified by PubMed, EmBase, and the Cochrane library from inception till April 2019. The pooled relative risks (RRs) with 95% confidence intervals (CIs) were calculated for the data collected using random-effects models.
RESULTS
Seven RCTs with a total of 6929 AS patients were enrolled. We noted that TAVR significantly increased the risk of transient ischemic attack (TIA) (RR: 1.43; 95%CI: 1.04-1.96; P = .029), and permanent pacemaker implantation (RR: 3.00; 95%CI: 1.70-5.30; P < .001). However, TAVR was associated with lower risk of post-procedural bleeding (RR: 0.57; 95%CI: 0.33-0.98; P = .042), new-onset or worsening of atrial fibrillation (RR: 0.32; 95%CI: 0.23-0.45; P < .001), acute kidney injury (RR: 0.40; 95%CI: 0.25-0.63; P < .001), and cardiogenic shock (RR: 0.34; 95%CI: 0.19-0.59; P < .001). The risk of aortic-valve reintervention at 1- (RR: 2.63; 95%CI: 1.34-5.15; P = .005), and 2 years (RR: 3.19; 95%CI: 1.63-6.24; P = .001) in low to intermediate surgical risk patients who received TAVR was significantly increased than those who received SAVR.
CONCLUSIONS
These findings indicated that low to intermediate surgical risk patients who received TAVR had low risk of complications, whereas the risk of TIA, permanent pacemaker implantation, and aortic-valve reintervention was increased.
Topics: Aortic Valve; Aortic Valve Stenosis; Global Health; Humans; Incidence; Postoperative Complications; Randomized Controlled Trials as Topic; Risk Factors; Transcatheter Aortic Valve Replacement
PubMed: 32926456
DOI: 10.1002/clc.23454 -
Journal of the American Heart... Jun 2022Background There is a concern that resheathing/repositioning of transcatheter heart valves during transcatheter aortic valve implantation (TAVI) may lead to an increased... (Meta-Analysis)
Meta-Analysis Review
Background There is a concern that resheathing/repositioning of transcatheter heart valves during transcatheter aortic valve implantation (TAVI) may lead to an increased risk of periprocedural complications. We aimed to evaluate the short- and long-term impact on clinical outcomes of resheathing for repositioning of transcatheter heart valves during TAVI procedures. Methods and Results We conducted a systematic search of Embase, MEDLINE, and Cochrane Central Register of Controlled Trials databases to identify studies comparing outcomes between patients requiring resheathing/repositioning during TAVI and those who did not. Random-effects meta-analyses were used to estimate the association of resheathing compared with no resheathing with clinical outcomes after TAVI. Seven studies including 4501 participants (pooled mean age, 80.9±7.4 years; 54% women; and 1374 [30.5%] patients requiring resheathing/repositioning) were included in this study. No significant differences between the 2 groups were identified with regards to safety: 30-day mortality (n=3125; odds ratio [OR], 0.74 [95% confidence interval [CI], 0.41-1.33]; =0%), stroke (n=4121; OR, 1.09 [95% CI, 0.74-1.62]; =0%), coronary obstruction (n=3000; OR, 2.35 [95% CI, 0.17-33.47]; =75%), major vascular complications (n=3125; OR, 0.92 [95% CI, 0.66-1.33]; =0%), major bleeding (n=3125; OR, 1.13 [95% CI, 0.94-2.01]; =39%), acute kidney injury (n=3495; OR, 1.30 [95% CI, 0.64-2.62]; =44%), and efficacy outcomes: device success (n=1196; OR, 0.77 [95% CI, 0.51-1.14]; =0%), need for a second valve (n=3170; OR, 2.86 [95% CI, 0.96-8.48]; =62%), significant (moderate or higher) paravalvular leak (n=1151; OR, 1.53 [95% CI, 0.83-2.80]; =0%), and permanent pacemaker implantation (n=1908; OR, 1.04 [95% CI, 0.68-1.57]; =58%). One-year mortality was similar between groups (n=1972; OR, 1.00 [95% CI, 0.68-1.47]; =0%). Conclusions Resheathing of transcatheter heart valves during TAVI is associated with similar periprocedural risk compared with no resheathing in several patient-important outcomes. These data support the safety of current self-expanding transcatheter heart valves with resheathing features. Registration URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42021273715.
Topics: Aged; Aged, 80 and over; Aortic Valve; Aortic Valve Stenosis; Female; Heart Valve Prosthesis; Humans; Male; Postoperative Complications; Risk Factors; Stroke; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 35699176
DOI: 10.1161/JAHA.121.024707 -
Systematic Reviews Feb 2019Transcatheter aortic valve replacement (TAVI) is an alternative treatment for patients with symptomatic severe aortic stenosis ineligible for surgical aortic valve... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Transcatheter aortic valve replacement (TAVI) is an alternative treatment for patients with symptomatic severe aortic stenosis ineligible for surgical aortic valve replacement (SAVR) or at increased perioperative risk. Due to continually emerging evidence, we performed a systematic review and meta-analysis comparing benefits and harms of TAVI, SAVR, medical therapy, and balloon aortic valvuloplasty.
METHODS
We searched MEDLINE, Embase, and Cochrane CENTRAL from 2002 to June 6, 2017. We dually screened abstracts and full-text articles for randomized controlled trials (RCTs) and propensity score-matched observational studies. Two investigators independently rated the risk of bias of included studies and determined the certainty of evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation). If data permitted, we performed meta-analyses using random- and fixed-effects models.
RESULTS
Out of 7755 citations, we included six RCTs (5862 patients) and 13 observational studies (6376 patients). In meta-analyses, patients treated with SAVR or TAVI had similar risks for mortality at 30 days (relative risk [RR] 1.05; 95% confidence interval [CI] 0.82 to 1.33) and 1 year (RR 1.02; 95% CI 0.93 to 1.13). TAVI had significantly lower risks for major bleeding but increased risks for major vascular complications, moderate or severe paravalvular aortic regurgitation, and new pacemaker implantation compared to SAVR. Comparing TAVI to medical therapy, mortality did not differ at 30 days but was significantly reduced at 1 year (RR 0.51; 95% CI 0.34 to 0.77).
CONCLUSIONS
Given similar mortality risks but different patterns of adverse events, the choice between TAVI and SAVR remains an individual one.
Topics: Humans; Aortic Valve Stenosis; Comparative Effectiveness Research; Research Design; Transcatheter Aortic Valve Replacement
PubMed: 30722786
DOI: 10.1186/s13643-019-0954-3 -
European Heart Journal Dec 2017To support decision-making regarding prosthetic valve selection in non-elderly adults, we aim to provide a detailed overview of outcome after contemporary mechanical... (Meta-Analysis)
Meta-Analysis Review
AIMS
To support decision-making regarding prosthetic valve selection in non-elderly adults, we aim to provide a detailed overview of outcome after contemporary mechanical aortic valve replacement (AVR).
METHODS AND RESULTS
A systematic review was conducted for papers reporting clinical outcome after AVR with bileaflet mechanical valves with a mean patient age ≥18 and ≤55 years, published between 1 January 1995 and 31 December 2015. Through meta-analysis outcomes were pooled and entered into a microsimulation model to calculate (event-free) life expectancy and lifetime event risk. Twenty-nine publications, encompassing a total of 5728 patients with 32 515 patient-years of follow-up (pooled mean follow-up: 5.7 years), were included. Pooled mean age at surgery was 48.0 years. Pooled early mortality risk was 3.15% (95% confidence interval (CI):2.37-4.23), late mortality rate was 1.55%/year (95%CI:1.25-1.92); 38.7% of late deaths were valve-related. Pooled thromboembolism rate was 0.90%/year (95%CI:0.68-1.21), major bleeding 0.85%/year (95%CI:0.65-1.12), nonstructural valve dysfunction 0.39%/year (95%CI:0.21-0.76), endocarditis 0.41%/year (95%CI:0.29-0.57), valve thrombosis 0.14%/year (95%CI:0.08-0.25), structural valve deterioration 0.00%/year (zero events observed), and reintervention 0.51%/year (95%CI:0.37-0.71), mostly due to nonstructural valve dysfunction and endocarditis. For a 45-year-old, for example, this translated to an estimated life expectancy of 19 years (general population: 34 years) and lifetime risks of thromboembolism, bleeding and reintervention of 18%, 15%, and 10%, respectively.
CONCLUSION
This study demonstrates that outcome after mechanical AVR in non-elderly adults is characterized by suboptimal survival and considerable lifetime risk of anticoagulation-related complications, but also reoperation. Non-elderly adult patients who are facing prosthetic valve selection are entitled to conveyance of evidence-based estimates of the risks and benefits of both mechanical and biological valve options in a shared decision-making process.
Topics: Adolescent; Adult; Aortic Valve; Aortic Valve Insufficiency; Aortic Valve Stenosis; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Male; Middle Aged; Postoperative Complications; Reoperation; Young Adult
PubMed: 29045647
DOI: 10.1093/eurheartj/ehx199 -
Heart & Lung : the Journal of Critical... 2024Transcatheter aortic valve replacement (TAVR) is a preferred treatment for patients with highly critical aortic stenosis (AS), which is a difficult and complicated... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Transcatheter aortic valve replacement (TAVR) is a preferred treatment for patients with highly critical aortic stenosis (AS), which is a difficult and complicated procedure, leaving a heavy economical burden on patients and national health insurance. Minimalist TAVR can simplify a part of the operation procedures, but the surgical efficacy and safety are still under debated.
OBJECTIVES
Explore the effectiveness and safety of minimalist TAVR in the treatment of patients with aortic stenosis.
METHODS
A systematic search of PubMed, Web of Science, and Embase databases was conducted for studies involving application of minimalist TAVR in patients with severe aortic stenosis, two researchers independently screened the literature, extracted data and Meta-analysis was performed using STATA 16.0 software.
RESULTS
Nine studies, involving a total of 3,148 AS patients, were included. Minimalist TAVR has similar surgical success rates compared to standardized TAVR, intraoperative fluoroscopy time, dosage of contrast agent, and total operative time were superior to standard TAVR. Regarding surgical complications, the incidence of permanent pacemaker placement and moderate to severe paravalvular leakage were similar for both TAVR, the risk of major vascular complications and major bleeding events in the minimalist TAVR was significantly lower than the standard TAVR. The risk of overall death, stroke, and cardiovascular-related readmission within 30 days was similar in both procedures.
CONCLUSION
Patients with severe aortic stenosis treated with minimalist TAVR have similar short-term efficacy as well as 30-day clinical outcomes to standard TAVR, while minimalist TAVR could reduce the risk of major vascular complications and bleeding complications.
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve Stenosis; Postoperative Complications; Treatment Outcome; Minimally Invasive Surgical Procedures
PubMed: 38788303
DOI: 10.1016/j.hrtlng.2024.05.008 -
European Heart Journal. Quality of Care... Jul 2021Multiple guidelines exist for the management of aortic stenosis (AS). We systematically reviewed current guidelines and recommendations, developed by national or...
Multiple guidelines exist for the management of aortic stenosis (AS). We systematically reviewed current guidelines and recommendations, developed by national or international medical organizations, on management of AS to aid clinical decision-making. Publications in MEDLINE and EMBASE between 1 June 2010 and 15 January 2021 were identified. Additionally, the International Guideline Library, National Guideline Clearinghouse, National Library for Health Guidelines Finder, Canadian Medical Association Clinical Practice Guidelines Infobase, and websites of relevant organizations were searched. Two reviewers independently screened titles and abstracts. Two reviewers assessed rigour of guideline development and extracted the recommendations. Of the seven guidelines and recommendations retrieved, five showed considerable rigour of development. Those rigourously developed, agreed on the definition of severe AS and diverse haemodynamic phenotypes, indications and contraindications for intervention in symptomatic severe AS, surveillance intervals in asymptomatic severe AS, and the importance of multidisciplinary teams (MDTs) and shared decision-making. Discrepancies exist in age and surgical risk cut-offs for recommending surgical aortic valve replacement (SAVR) vs. transcatheter aortic valve implantation (TAVI), the use of biomarkers and complementary multimodality imaging for decision-making in asymptomatic patients and surveillance intervals for non-severe AS. Contemporary guidelines for AS management agree on the importance of MDT involvement and shared decision-making for individualized treatment and unanimously indicate valve replacement in severe, symptomatic AS. Discrepancies exist in thresholds for age and procedural risk used in choosing between SAVR and TAVI, role of biomarkers and complementary imaging modalities to define AS severity and risk of progression in asymptomatic patients.
Topics: Aortic Valve; Aortic Valve Stenosis; Canada; Heart Valve Prosthesis Implantation; Humans; Transcatheter Aortic Valve Replacement
PubMed: 33751049
DOI: 10.1093/ehjqcco/qcab016 -
Annals of Internal Medicine Sep 2016The comparative benefits and harms of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) for patients with aortic stenosis are... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The comparative benefits and harms of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) for patients with aortic stenosis are unclear.
PURPOSE
To compare clinical outcomes, including early (≤30-day) and midterm (≤1-year) mortality, in adults with severe aortic stenosis undergoing either TAVI or SAVR.
DATA SOURCES
MEDLINE, Cochrane, and Scopus databases (without language restrictions) from April 2002 to 5 April 2016; multiple registries and Web sites; scientific meeting presentations.
STUDY SELECTION
Five randomized trials and 31 observational matched studies comparing mortality outcomes after TAVI or SAVR.
DATA EXTRACTION
Two investigators independently extracted study data and rated risk of bias.
DATA SYNTHESIS
16 638 patients were analyzed. Overall, there was no statistically significant difference between TAVI and SAVR in early (odds ratio [OR], 1.01 [95% CI, 0.81 to 1.26]) or midterm (OR, 0.96 [CI, 0.81 to 1.14]) all-cause mortality. Analyses restricted to trials (early: OR, 0.80 [CI, 0.51 to 1.25]; midterm: OR, 0.90 [CI, 0.64 to 1.26]) were inconclusive, with wide CIs, whereas analyses of matched studies were similar to the overall results. Transfemoral TAVI provided mortality benefits over SAVR in trials. Analyses restricted to studies of patients at low to intermediate risk showed statistically nonsignificant reductions in early (OR, 0.67 [CI, 0.42 to 1.07]) and midterm (OR, 0.91 [CI, 0.67 to 1.23]) mortality with TAVI. Incidence of periprocedural myocardial infarction, major bleeding, acute kidney injury, and new-onset atrial fibrillation was lower with TAVI, but risk for pacemaker implantation, vascular complications, and paravalvular leak increased. Overall, there was a statistically nonsignificant increased risk in long-term (2- to 5-year) all-cause mortality with TAVI (OR, 1.28 [CI, 0.97 to 1.69]), whereas long-term mortality outcomes in patients at low to intermediate risk were inconclusive, with wide CIs (OR, 1.06 [CI, 0.59 to 1.91]).
LIMITATION
The number of trials was limited, and study designs and patient characteristics were heterogeneous.
CONCLUSION
Compared with SAVR, TAVI may have similar or better early and midterm outcomes for adults with aortic stenosis, including those at low to intermediate risk.
PRIMARY FUNDING SOURCE
None.
Topics: Adult; Aortic Valve Stenosis; Cause of Death; Comparative Effectiveness Research; Heart Valve Prosthesis Implantation; Humans; Postoperative Complications; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 27272666
DOI: 10.7326/M16-0060 -
International Journal of Cardiology 2015
Review
Topics: Aged, 80 and over; Aortic Valve Stenosis; Combined Modality Therapy; Coronary Artery Disease; Female; Humans; Male; Percutaneous Coronary Intervention; Prognosis; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 25841148
DOI: 10.1016/j.ijcard.2015.03.391