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Open Heart May 2022The management of severe aortic stenosis mandates consideration of aortic valve intervention for symptomatic patients. However, for asymptomatic patients with severe... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
The management of severe aortic stenosis mandates consideration of aortic valve intervention for symptomatic patients. However, for asymptomatic patients with severe aortic stenosis, recent randomised trials supported earlier intervention. We conducted a systematic review and meta-analysis to evaluate all the available data comparing the two management strategies.
METHODS
PubMed, Cochrane and Web of Science databases were systematically searched from inception until 10 January 2022. The search key terms were 'asymptomatic', 'severe aortic stenosis' and 'intervention'.
RESULTS
Meta-analysis of two published randomised trials, AVATAR and RECOVERY, included 302 patients and showed that early intervention resulted in 55% reduction in all-cause mortality (HR=0.45, 95% CI 0.24 to 0.86; I 0%) and 79% reduction in risk of hospitalisation for heart failure (HR=0.21, 95% CI 0.05 to 0.96; I 15%). There was no difference in risk of cardiovascular death between the two groups (HR=0.36, 95% CI 0.03 to 3.78; I 78%). Additionally, meta-analysis of eight observational studies showed improved mortality in patients treated with early intervention (HR=0.38, 95% CI 0.26 to 0.56; I 77%).
CONCLUSION
This meta-analysis provides evidence that, in patients with severe asymptomatic aortic stenosis, early intervention reduces all-cause mortality and improves outcomes compared with conservative management. While this is very encouraging, further randomised controlled studies are needed to draw firm conclusions and identify the optimal timing of intervention.
PROSPERO REGISTRATION NUMBER
CRD42022301037.
Topics: Aortic Valve; Aortic Valve Stenosis; Conservative Treatment; Heart Failure; Humans; Transcatheter Aortic Valve Replacement
PubMed: 35581008
DOI: 10.1136/openhrt-2022-001982 -
The Journal of Invasive Cardiology Mar 2022Nonagenarians represent only a small proportion of patients included in large transcatheter aortic valve replacement (TAVR) trials, but will become a relevant future... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Nonagenarians represent only a small proportion of patients included in large transcatheter aortic valve replacement (TAVR) trials, but will become a relevant future population in need of treatment due to demographic change. Thus, this study sought to evaluate outcomes of TAVR for the treatment of severe aortic stenosis (AS) in nonagenarian patients.
METHODS
We screened Medline/Pubmed for studies that stated specific outcomes for nonagenarians undergoing TAVR. A weighted meta-analysis was conducted, calculating pooled estimate rates using a binary random-effects model for dichotomous variables, and comparing non-dichotomous outcomes with a continuous random-effects model.
RESULTS
Data from 23 studies including 16,094 nonagenarians were merged; 53.4% were women. Despite reasonable rates of comorbidities, Society of Thoracic Surgeons mortality risk score was 10.2 ± 5.4. Pooled estimate rate of procedural success was 94.1% (95% confidence interval [CI], 91.7-96.6), with major vascular complications occurring in 6.3% (95% CI, 2.7-9.8) and at least moderate postprocedural paravalvular leak in 7.5% (95% CI, 4.4-10.6). The rate of periprocedural stroke or transient ischemic attack was 2.6% (95% CI, 2.0-3.2). At 30 days, the pooled estimate of mortality was 6.1% (95% CI, 4.7-7.4) and a permanent pacemaker was implanted in 12.6% (95% CI, 7.6-17.6). After 1 year, the mortality rate was 20.5% (95% CI, 15.9-25.1).
CONCLUSION
TAVR in nonagenarians is an effective and safe procedure, with encouraging outcomes given the general life expectancy of these patients. Currently, only selected nonagenarians are undergoing TAVR, but their number will grow as life expectancy continues to increase in the developed world. Specific research to identify ideal candidates and techniques in this cohort is needed.
Topics: Aged, 80 and over; Aortic Valve; Aortic Valve Stenosis; Female; Humans; Male; Nonagenarians; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 35235529
DOI: No ID Found -
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 -
The Cochrane Database of Systematic... Sep 2016Aortic valve stenosis is the most common type of valvular heart disease in the USA and Europe. Aortic valve stenosis is considered similar to atherosclerotic disease.... (Review)
Review
BACKGROUND
Aortic valve stenosis is the most common type of valvular heart disease in the USA and Europe. Aortic valve stenosis is considered similar to atherosclerotic disease. Some studies have evaluated statins for aortic valve stenosis.
OBJECTIVES
To evaluate the effectiveness and safety of statins in aortic valve stenosis.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS - IBECS, Web of Science and CINAHL Plus. These databases were searched from their inception to 24 November 2015. We also searched trials in registers for ongoing trials. We used no language restrictions.
SELECTION CRITERIA
Randomised controlled clinical trials (RCTs) comparing statins alone or in association with other systemic drugs to reduce cholesterol levels versus placebo or usual care.
DATA COLLECTION AND ANALYSIS
Primary outcomes were severity of aortic valve stenosis (evaluated by echocardiographic criteria: mean pressure gradient, valve area and aortic jet velocity), freedom from valve replacement and death from cardiovascular cause. Secondary outcomes were hospitalisation for any reason, overall mortality, adverse events and patient quality of life.Two review authors independently selected trials for inclusion, extracted data and assessed the risk of bias. The GRADE methodology was employed to assess the quality of result findings and the GRADE profiler (GRADEPRO) was used to import data from Review Manager 5.3 to create a 'Summary of findings' table.
MAIN RESULTS
We included four RCTs with 2360 participants comparing statins (1185 participants) with placebo (1175 participants). We found low-quality evidence for our primary outcome of severity of aortic valve stenosis, evaluated by mean pressure gradient (mean difference (MD) -0.54, 95% confidence interval (CI) -1.88 to 0.80; participants = 1935; studies = 2), valve area (MD -0.07, 95% CI -0.28 to 0.14; participants = 127; studies = 2), and aortic jet velocity (MD -0.06, 95% CI -0.26 to 0.14; participants = 155; study = 1). Moderate-quality evidence showed no effect on freedom from valve replacement with statins (risk ratio (RR) 0.93, 95% CI 0.81 to 1.06; participants = 2360; studies = 4), and no effect on muscle pain as an adverse event (RR 0.91, 95% CI 0.75 to 1.09; participants = 2204; studies = 3; moderate-quality evidence). Low- and very low-quality evidence showed uncertainty around the effect of statins on death from cardiovascular cause (RR 0.80, 95% CI 0.56 to 1.15; participants = 2297; studies = 3; low-quality evidence) and hospitalisation for any reason (RR 0.84, 95% CI 0.39 to 1.84; participants = 155; study = 1; very low-quality evidence). None of the four included studies reported on overall mortality and patient quality of life.
AUTHORS' CONCLUSIONS
Result findings showed uncertainty surrounding the effect of statins for aortic valve stenosis.The quality of evidence from the reported outcomes ranged from moderate to very low. These results give support to European and USA guidelines (2012 and 2014, respectively) that so far there is no clinical treatment option for aortic valve stenosis.
PubMed: 27594276
DOI: 10.1002/14651858.CD009571.pub2 -
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 -
Journal of Geriatric Cardiology : JGC Jan 2023With the introduction of transcatheter aortic valve replacement and an evolving understanding of the natural progression and history of aortic stenosis, the potential...
BACKGROUND
With the introduction of transcatheter aortic valve replacement and an evolving understanding of the natural progression and history of aortic stenosis, the potential for earlier intervention in appropriate patients is promising; however, the benefit of aortic valve replacement in moderate aortic stenosis remains unclear.
METHODS
Pubmed, Embase, and the Cochrane Library databases were searched up until 30 of December 2021 using keywords including moderate aortic stenosis and aortic valve replacement. Studies reporting all-cause mortality and outcomes in early aortic valve replacement (AVR) compared to conservative management in patients with moderate aortic stenosis were included. Hazard ratios were generated using random-effects meta-analysis to determine effect estimates.
RESULTS
3470 publications were screened with title and abstract review, which left 169 articles for full-text review. Of these studies, 7 met inclusion criteria and were included, totalling 4,827 patients. All studies treated AVR as a time-dependent co-variable in cox-regression multivariate analysis of all-cause mortality. Intervention with surgical or transcatheter AVR was associated with a 45% decreased risk of all-cause mortality (HR = 0.55 [0.42-0.68], = 51.5%, < 0.001). All studies were representative of the overall cohort with appropriate sample sizes, with no evidence of publication, detection, or information biases in any of the studies.
CONCLUSION
In this systematic review and meta-analysis, we report a 45% reduction in all-cause mortality in patients with moderate aortic stenosis who were treated with early aortic valve replacement compared to a strategy of conservative management. Randomised control trials are awaited to determine the utility of AVR in moderate aortic stenosis.
PubMed: 36875167
DOI: 10.26599/1671-5411.2023.01.003 -
Revista Portuguesa de Cardiologia :... Apr 2017Aortic stenosis (AS) is a complex systemic valvular and vascular disease with a high prevalence in developed countries. The new entity "paradoxical low-flow,... (Review)
Review
Aortic stenosis (AS) is a complex systemic valvular and vascular disease with a high prevalence in developed countries. The new entity "paradoxical low-flow, low-gradient aortic stenosis" refers to cases in which patients have severe AS based on assessment of aortic valve area (AVA) (≤1 cm) or indexed AVA (≤0.6 cm/m), but paradoxically have a low mean transvalvular gradient (<40 mmHg) and a low stroke volume index (≤35 ml/m), despite preserved left ventricular ejection fraction (≥50%). A search was carried out in the PubMed database on paradoxical AS for the period 2007-2014. A total of 57 articles were included for this review. The prevalence of paradoxical AS ranged from 3% to 35% of the population with severe degenerative AS. It was more frequent in females and in older patients. Paradoxical AS was associated with characteristic left ventricular remodeling as well as an increase in systemic arterial stiffness. It was noted that there may be errors and inaccuracies in the calculation of AVA by the continuity equation, which could erroneously suggest the paradoxical phenotype. There are new diagnostic methods to facilitate the study of AS, such as aortic valve calcium score, valvuloarterial impedance and the longitudinal mechanics of the left ventricle. With regard to its natural history, it is not clear whether paradoxical AS corresponds to an advance stage of the disease or if paradoxical AS patients have a distinct phenotype with specific characteristics. Valve replacement, either surgical or percutaneous, may be indicated in patients with severe and symptomatic paradoxical AS.
Topics: Aortic Valve Stenosis; Humans
PubMed: 28336114
DOI: 10.1016/j.repc.2016.09.010 -
Circulation Oct 2020The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention with drug-eluting stents remains uncertain. We compared short-term... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention with drug-eluting stents remains uncertain. We compared short-term (<6-month) DAPT followed by aspirin or P2Y12 inhibitor monotherapy; midterm (6-month) DAPT; 12-month DAPT; and extended-term (>12-month) DAPT after percutaneous coronary intervention with drug-eluting stents.
METHODS
Twenty-four randomized, controlled trials were selected using Medline, Embase, Cochrane library, and online databases through September 2019. The coprimary end points were myocardial infarction and major bleeding, which constituted the net clinical benefit. A frequentist network meta-analysis was conducted with a random-effects model.
RESULTS
In 79 073 patients, at a median follow-up of 18 months, extended-term DAPT was associated with a reduced risk of myocardial infarction in comparison with 12-month DAPT (absolute risk difference, -3.8 incident cases per 1000 person-years; relative risk, 0.68 [95% CI, 0.54-0.87]), midterm DAPT (absolute risk difference, -4.6 incident cases per 1000 person-years; relative risk, 0.61 [0.45-0.83]), and short-term DAPT followed by aspirin monotherapy (absolute risk difference, -6.1 incident cases per 1000 person-years; relative risk, 0.55 [0.37-0.83]), or P2Y12 inhibitor monotherapy (absolute risk difference, -3.7 incident cases per 1000 person-years; relative risk, 0.69 [0.51-0.95]). Conversely, extended-term DAPT was associated with a higher risk of major bleeding than all other DAPT groups. In comparison with 12-month DAPT, no significant differences in the risks of ischemic end points or major bleeding were observed with midterm or short-term DAPT followed by aspirin monotherapy, with the exception that short-term DAPT followed by P2Y12 inhibitor monotherapy was associated with a reduced risk of major bleeding. There were no significant differences with respect to mortality between the different DAPT strategies. In acute coronary syndrome, extended-term in comparison with 12-month DAPT was associated with a reduced risk of myocardial infarction without a significant increase in the risk of major bleeding.
CONCLUSIONS
The present network meta-analysis suggests that, in comparison with 12-month DAPT, short-term DAPT followed by P2Y12 inhibitor monotherapy reduces major bleeding after percutaneous coronary intervention with drug-eluting stents, whereas extended-term DAPT reduces myocardial infarction at the expense of more bleeding events.
Topics: Acute Coronary Syndrome; Aspirin; Drug-Eluting Stents; Humans; Incidence; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Randomized Controlled Trials as Topic
PubMed: 32795096
DOI: 10.1161/CIRCULATIONAHA.120.046308 -
Netherlands Heart Journal : Monthly... Dec 2023The importance of revascularisation of significant coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is unclear....
OBJECTIVE
The importance of revascularisation of significant coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is unclear. Despite the lack of randomised controlled trials comparing different revascularisation strategies, guidelines currently recommend percutaneous coronary intervention (PCI) in patients with significant proximal CAD undergoing TAVI.
METHODS
In this systematic review and meta-analysis, a systematic search was conducted to identify studies comparing TAVI with and without PCI in patients with significant CAD on pre-TAVI coronary angiography. Endpoints were all-cause mortality, cardiac death, stroke, myocardial infarction and major bleeding.
RESULTS
In total, 14 studies were included, involving 3838 patients, of whom 1806 (47%) underwent PCI before TAVI. All-cause mortality did not differ significantly between TAVI with and without preceding PCI at 30 days, 1 year and > 1 year. There were no significant differences in risk of cardiac death, stroke or myocardial infarction between the groups. However, TAVI performed with PCI resulted in a higher risk of major bleeding within 30 days after TAVI (odds ratio: 0.66; 95% confidence interval: 0.46-0.94).
CONCLUSION
This systematic review and meta-analysis showed no significant differences in clinical outcomes between patients with concomitant significant CAD who were treated with TAVI with and without preceding PCI at both short- and long-term follow-up. However, there was a higher risk of major bleeding at 30 days in patients undergoing TAVI with preceding PCI. In the context of serious risk of bias in the included studies, results of randomised controlled trials are warranted.
PubMed: 37910336
DOI: 10.1007/s12471-023-01824-w -
Journal of the American Heart... Dec 2022Background In the absence of randomized controlled trials, reports from nonrandomized studies comparing valve-in-valve implantation (ViV) to redo surgical aortic valve... (Meta-Analysis)
Meta-Analysis Review
Valve-in-Valve Transcatheter Aortic Valve Replacement Versus Redo Surgical Aortic Valve Replacement for Failed Surgical Aortic Bioprostheses: A Systematic Review and Meta-Analysis.
Background In the absence of randomized controlled trials, reports from nonrandomized studies comparing valve-in-valve implantation (ViV) to redo surgical aortic valve replacement (rAVR) have shown inconsistent results. Methods and Results PubMed/MEDLINE, Google Scholar, and CENTRAL (Cochrane Central Register of Controlled Trials) were searched through December 2021. Meta-Analysis of Observational Studies in Epidemiology guidelines were followed. The protocol was registered at the International Prospective Register of Systematic Reviews. Random effects models were applied. The primary outcomes of interest were short-term and midterm mortality. Secondary outcomes included stroke, myocardial infarction, acute renal failure, and permanent pacemaker implantation, as well as prosthetic aortic valve regurgitation, mean transvalvular gradient, and severe prosthesis-patient mismatch. Of 8881 patients included in 15 studies, 4458 (50.2%) underwent ViV and 4423 (49.8%) rAVR. Short-term mortality was 2.8% in patients undergoing ViV compared with 5.0% in patients undergoing rAVR (risk ratio [RR] 0.55 [95% CI, 0.34-0.91], =0.02). Midterm mortality did not differ in patients undergoing ViV compared with patients undergoing rAVR (hazard ratio, 1.27 [95% CI, 0.72-2.25]). The rate of acute kidney failure was lower following ViV, (RR, 0.54 [95% CI, 0.33-0.88], =0.02), whereas prosthetic aortic valve regurgitation (RR, 4.18 [95% CI, 1.88-9.3], =0.003) as well as severe patient-prothesis mismatch (RR, 3.12 [95% CI, 2.35-4.1], <0.001) occurred more frequently. The mean transvalvular gradient was higher following ViV (standard mean difference, 0.44 [95% CI, 0.15-0.72], =0.008). There were no significant differences between groups with respect to stroke (=0.26), myocardial infarction (=0.93), or pacemaker implantation (=0.21). Conclusions Results of this meta-analysis demonstrate better short-term mortality after ViV compared with rAVR. Midterm mortality was similar between groups. Given the likely selection bias in these individual reports, an adequately powered multicenter randomized clinical trial with sufficiently long follow-up in patients with low-to-intermediate surgical risk is warranted. Registration URL: crd.york.ac.uk/prospero/. Unique identifier: CRD42021228752.
Topics: Humans; Aortic Valve; Transcatheter Aortic Valve Replacement; Bioprosthesis; Reoperation; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Aortic Valve Stenosis; Aortic Valve Insufficiency; Myocardial Infarction; Stroke; Treatment Outcome; Risk Factors; Randomized Controlled Trials as Topic; Multicenter Studies as Topic
PubMed: 36533610
DOI: 10.1161/JAHA.121.024848