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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 -
Journal of Cardiac Surgery Apr 2022Native mitral valve infective endocarditis (IE) plagues patients and surgeons alike because of its high mortality and recurrence rates as well as poor prognosis. Mitral... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Native mitral valve infective endocarditis (IE) plagues patients and surgeons alike because of its high mortality and recurrence rates as well as poor prognosis. Mitral valve repair (MVP) and mitral valve replacement (MVR) are two main surgical methods. However, the question of which benefits patients more remains controversial. Thus, we conducted a meta-analysis to systematically review the two approaches, focusing on the early survival rate and long-term outcomes.
METHODS
A meta-analysis and systematic review were conducted using studies sourced from the PubMed, Embase, and Cochrane literature databases to compare MVP and MVR, with data extracted for baseline characteristics, mortality, survival, recurrent endocarditis, and valve reoperation. Risk ratio (RR) or hazard ratio (HR) values were calculated, and publication bias was tested.
RESULTS
A total of 17 relevant publications with a total population of 3759 patients, with 1180 patients having undergone MVP and 2579 patients having undergone MVR, respectively, were analyzed. Patients who underwent MVP may benefit from a lower risk of early mortality (RR, 0.51; 95% confidence interval [CI], 0.39-0.66; p < .00001), a higher long-term survival rate (HR, 0.69; 95% CI, 0.58-0.81; p < .001; I = 0%), and a lower risk of recurrence (RR, 0.66; 95% CI, 0.40-1.09; p = .10; I = 0%). However, a similar risk of reoperation was observed for both groups (RR, 1.02; 95% CI, 0.36-2.91; p = .96; I = 43%).
CONCLUSION
This meta-analysis suggests that MVP may lead to better outcomes compared to MVR. Among patients with mitral valve IE, MVP can reduce in-hospital mortality, improve long-term survival, and has a lower risk of recurrent endocarditis. As a result, MVP may be suitable as a primary treatment choice and should be considered whenever possible in most IE patients.
Topics: Cardiac Surgical Procedures; Endocarditis; Endocarditis, Bacterial; Heart Valve Prosthesis Implantation; Humans; Mitral Valve; Treatment Outcome
PubMed: 35032059
DOI: 10.1111/jocs.16227 -
Current Problems in Cardiology Dec 2023Tricuspid regurgitation (TR) is traditionally treated surgically, but isolated transcatheter tricuspid valve repair (ITTVR) offers a less invasive option. This study... (Meta-Analysis)
Meta-Analysis Review
Tricuspid regurgitation (TR) is traditionally treated surgically, but isolated transcatheter tricuspid valve repair (ITTVR) offers a less invasive option. This study conducts a meta-analysis and systematic review to evaluate ITTVR outcomes in patients with TR. Database searches until March 2023 identified studies assessing ITTVR safety and efficacy in moderate/severe TR patients. Primary outcomes analyzed were severe TR, NYHA functional class improvement, and 6-minute walking distance. Meta-analyses used Risk ratio (RR) or mean difference with a random effects model. The review included 25 studies with 2421 patients. ITTVR improved NYHA functional class (RR: 3.262), reduced TR severity (RR: 0.303), and enhanced 6-minute walking distance (MD: +47.077 m). Echocardiographic parameters improved, including reductions in TR vena contracta, TR EROA, septolateral tricuspid annular diameter, RVEDD, RV FAC, and TAPSE. LVEF and PASP showed no significant changes. ITTVR improves functional outcomes and echocardiographic parameters in TR patients.
Topics: Humans; Tricuspid Valve; Treatment Outcome; Tricuspid Valve Insufficiency; Echocardiography; Heart Valve Prosthesis Implantation; Severity of Illness Index; Cardiac Catheterization
PubMed: 37479006
DOI: 10.1016/j.cpcardiol.2023.101985 -
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 -
European Heart Journal May 2017To review maternal and foetal outcomes in women with mechanical heart valves (MHVs) treated with vitamin-K antagonists (VKAs), first-trimester heparin followed by VKAs... (Meta-Analysis)
Meta-Analysis Review
AIMS
To review maternal and foetal outcomes in women with mechanical heart valves (MHVs) treated with vitamin-K antagonists (VKAs), first-trimester heparin followed by VKAs (sequential treatment), low molecular weight heparin (LMWH) and unfractionated heparin (UFH) during pregnancy, in order to inform practice.
METHODS AND RESULTS
Medline, Embase and Central were searched from inception until February 2016. Two reviewers independently screened 1786 titles, reviewed 110 full-texts and extracted data and assessed risk-of-bias from 46 articles. Pooled incidence (95% confidence intervals) was calculated for maternal and foetal outcomes. Included studies had a moderate or high risk-of-bias. With VKAs, sequential treatment and LMWH, maternal mortality occurred in 0.9% (0.4-1.4), 2.0% (0.8-3.1) and 2.9% (0.2-5.7), thromboembolic complications in 2.7% (1.4-4.0), 5.8% (3.8-7.7) and 8.7% (3.9-13.4), livebirths in 64.5% (48.8-80.2), 79.9% (74.3-85.6) and 92.0% (86.1-98.0) and anticoagulant-related foetal/neonatal adverse events (embryopathy or foetopathy) in 2.0% (0.3-3.7), 1.4% (0.3-2.5) and 0%, respectively. When UFH is used throughout pregnancy, 11.2% (2.8-19.6) suffered thromboembolic complications. Foetal loss and adverse events occurred with first-trimester warfarin doses ≤ 5 mg/day, although there were more livebirths [83.6% (75.8-91.4) vs. 43.9% (32.8-55.0)] and fewer foetal anomalies [2.3% (0.7-4.0) vs. 12.4% (3.3-21.6)] with lower doses than with warfarin > 5 mg/day.
CONCLUSIONS
VKAs are associated with fewest maternal complications but also with fewest livebirths. Sequential treatment does not eliminate anticoagulant-related foetal/neonatal adverse events. LMWH is associated with the highest number of livebirths. The safety of UFH throughout pregnancy and first-trimester warfarin ≤ 5 mg/day remains unconfirmed.
Topics: Anticoagulants; Female; Fetal Death; Fetal Diseases; Heart Valve Prosthesis; Heparin; Heparin, Low-Molecular-Weight; Humans; Incidence; Maternal Mortality; Pregnancy; Pregnancy Complications, Cardiovascular; Pregnancy Outcome; Pregnancy Trimester, First; Thromboembolism; Vitamin K; Warfarin
PubMed: 28329059
DOI: 10.1093/eurheartj/ehx032 -
ESC Heart Failure Oct 2022Aortic stenosis (AS) and cardiac amyloidosis (CA) are typical diseases of the elderly. Up to 16% of older adults with severe AS referred to transcatheter aortic valve... (Meta-Analysis)
Meta-Analysis
AIMS
Aortic stenosis (AS) and cardiac amyloidosis (CA) are typical diseases of the elderly. Up to 16% of older adults with severe AS referred to transcatheter aortic valve replacement (TAVR) have a concomitant diagnosis of CA. CA-AS population suffers from reduced functional capacity and worse prognosis than AS patients. As the prognostic impact of TAVR in patients with CA-AS has been historically questioned and in light of recently published evidence, we aim to provide a comprehensive synthesis of the efficacy and safety of TAVR in CA-AS patients.
METHODS AND RESULTS
We performed a systematic review and meta-analysis of studies: (i) evaluating mortality with TAVR as compared with medical therapy in CA-AS patients and (ii) reporting complications and clinical outcomes of TAVR in CA-AS patients as compared with patients with AS alone. A total of seven observational studies were identified: four reported mortality with TAVR, and four reported complications and clinical outcomes after TAVR of patients with CA-AS compared with AS alone patients. In patients with CA-AS, the risk of mortality was lower with TAVR (n = 44) as compared with medical therapy (n = 36) [odds ratio (OR) 0.23, 95% confidence interval (CI) 0.07-0.73, I = 0%, P = 0.001, number needed to treat = 3]. The safety profile of TAVR seems to be similar in patients with CA-AS (n = 75) as compared with those with AS alone (n = 536), with comparable risks of stroke, vascular complications, life-threatening bleeding, acute kidney injury, and 30 day mortality, although CA-AS was associated with a trend towards an increased risk of permanent pacemaker implantation (OR 1.76, 95% CI 0.91-4.09, I = 0%, P = 0.085). CA is associated with a numerically higher rate of long-term mortality and rehospitalizations following TAVR in patients with CA-AS as compared with those with AS alone.
CONCLUSIONS
TAVR is an effective and safe procedure in CA-AS patients, with a substantial survival benefit as compared with medical therapy, and a safety profile comparable with patients with AS alone except for a trend towards higher risk of permanent pacemaker implantation.
Topics: Humans; Aged; Transcatheter Aortic Valve Replacement; Aortic Valve; Heart Valve Prosthesis Implantation; Risk Factors; Aortic Valve Stenosis; Amyloidosis
PubMed: 35770333
DOI: 10.1002/ehf2.13876 -
Clinical Cardiology Jul 2022Either a mechanical or bioprosthetic valve is used in patients undergoing mitral valve replacement (MVR). However, the optimal mitral prosthesis remains controversial.... (Meta-Analysis)
Meta-Analysis Review
Either a mechanical or bioprosthetic valve is used in patients undergoing mitral valve replacement (MVR). However, the optimal mitral prosthesis remains controversial. The aim of this meta-analysis was thus to compare outcomes between mechanical mitral valve replacement (MVRm) and bioprosthetic mitral valve replacement (MVRb) for MVR patients. We searched Embase, PubMed, Web of Science, and Cochrane Library databases from January 1, 2000 to October 31, 2021 for studies that directly compared surgical outcomes of MVRm and MVRb. A total of 22 studies with 35 903 patients were included in the meta-analysis (n = 23 868 MVRm and n = 12 035 MVRb). The MVRm group displayed lower long-term all causes mortality (HR, 0.84; 95% confidence interval [CI]: 0.77-0.91; p < .0001; I² = 51%), and fewer mitral reoperation (hazard ratio [HR]: 0.34; 95% CI: 0.23-0.50; p < .00001; I² = 74%) than MVRb group. However, the MVRm group was associated with a greater risk of major bleeding events (HR: 1.21; 95% CI: 1.14-1.29; p < .00001; I² = 0%), stroke and systemic embolism (HR: 1.20; 95% CI: 1.10-1.32; p < .0001; I² = 0%) in matched or adjusted data. No significant difference was observed between MVRm and MVRb on operative mortality in matched/adjusted group (risk ratios: 0.83; 95% CI: 0.66-1.05; p = .12; I² = 0%). The results were consistent with patients aged under 70 years old. Patients who received a MVRm is associated with 16% lower risk of long-term mortality and 66% lower risk of mitral reoperation, but 20% greater risk of stroke or systemic embolism, 21% greater risk of major bleeding compared with MVRb in matched/adjusted studies group, which were consistent to patients younger than the age of 70 years who underwent MVR.
Topics: Aged; Biological Products; Bioprosthesis; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Hemorrhage; Humans; Mitral Valve; Reoperation; Retrospective Studies; Stroke; Treatment Outcome
PubMed: 35665516
DOI: 10.1002/clc.23854 -
Current Cardiology Reviews 2022Paravalvular Leak (PVL) refers to the retrograde flow of blood in the space between an implanted cardiac valve and native tissue. These are unfortunately but luckily...
BACKGROUND
Paravalvular Leak (PVL) refers to the retrograde flow of blood in the space between an implanted cardiac valve and native tissue. These are unfortunately but luckily relatively uncommon complications of prosthetic valve replacement that, especially when moderate or severe, have important clinical consequences.
OBJECTIVE
Addressing PVL requires a multidisciplinary team to properly diagnose this process and choose the corrective option most likely to result in success.
METHODS
A comprehensive literature search was undertaken to formulate this narrative review.
RESULTS
This review highlights the complex nature of PVL and the promising contemporary treatments available.
CONCLUSION
Clinicians should be adept at recognizing PVL and characterizing it using multimodality imaging. Using the many available tools and a multidisciplinary approach should lead to favorable outcomes in patients with PVL.
Topics: Humans; Aortic Valve; Aortic Valve Insufficiency; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Retrospective Studies; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 35546743
DOI: 10.2174/1573403X18666220511113310 -
Thrombosis and Haemostasis Feb 2009Optimal timing for restarting anticoagulant therapy after intracranial bleeding is a critical issue. The purpose of this systematic review is to summarize published... (Review)
Review
Optimal timing for restarting anticoagulant therapy after intracranial bleeding is a critical issue. The purpose of this systematic review is to summarize published studies on the management of oral anticoagulant therapy after intracranial bleeding secondary to the use of vitamin K antagonists in patients with a mechanical heart valve. A computer-assisted search of the MEDLINE and EMBASE electronic databases till January 2008 was performed. Two investigators independently performed study selection and completed a predefined quality assessment and data extraction form. Main inclusion criterion was the enrolment of patients with a mechanical heart valve and intracranial haemorrhage during oral anticoagulant treatment. Any randomised controlled trial, observational cohort study, case series and reports was included. No randomised controlled trials were identified. Six observational cohort studies were included in the final analysis. All studies were of low quality. A total of 120 patients were enrolled. Anticoagulation was restarted within a broad time range (2 days to 3 months). Four ischaemic strokes and two recurrent cerebral haemorrhages occurred after anticoagulation was restarted after a mean follow-up of 7.9 months. Eighteen patients were described in the selected case reports. Anticoagulant therapy was restarted within four days to eight weeks. Two patients had a recurrent haemorrhagic event, and no ischaemic events were reported. In conclusion, restarting oral anticoagulant therapy few days and, indirectly, stopping anticoagulant therapy for a few days (even for 7-14 days) after the occurrence of cerebral haemorrhage are both safe. However, well-designed studies are strongly recommended to provide better evidence.
Topics: Administration, Oral; Adolescent; Adult; Aged; Anticoagulants; Child; Drug Administration Schedule; Female; Heart Valve Diseases; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Intracranial Hemorrhages; Male; Middle Aged; Risk Assessment; Thromboembolism; Treatment Outcome; Vitamin K
PubMed: 19190812
DOI: No ID Found -
Journal of Cardiac Surgery Jul 2021With the growing contemporary use of bioprosthetic valves, whose limited long-term durability has been well-documented, an increase in the need for reintervention is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND/AIM
With the growing contemporary use of bioprosthetic valves, whose limited long-term durability has been well-documented, an increase in the need for reintervention is expected. We perform a meta-analysis to compare the current standard of care, redo surgical aortic valve replacement (Redo SAVR) with the less invasive alternative, valve-in-valve transcatheter aortic valve replacement (ViV TAVR) for treating structural valve deterioration.
METHODS
After a comprehensive literature search, studies comparing ViV TAVR to Redo SAVR were pooled to perform a pairwise meta-analysis using the random-effects model. Primary outcomes were 30-day and follow-up mortality.
RESULTS
A total of nine studies including 9127 patients were included. ViV TAVR patients were significantly older (mean difference [MD], 5.82; p = .0002) and more frequently had hypercholesterolemia (59.7 vs. 60.0%; p = .0006), coronary artery disease (16.1 vs. 16.1%; p = .04), periphery artery disease (15.4 vs. 5.7%; p = .004), chronic obstructive pulmonary disease (29.3 vs. 26.2%; p = .04), renal failure (30.2 vs. 24.0%; p = .009), and >1 previous cardiac surgery (23.6 vs. 15.9%; p = .004). Despite this, ViV TAVR was associated with decreased 30-day mortality (OR, 0.56; p < .0001). Conversely, Redo SAVR had lower 30-day paravalvular leak (OR, 6.82; p = .04), severe patient-prosthesis mismatch (OR, 3.77; p < .0001), and postoperative aortic valve gradients (MD, 5.37; p < .0001). There was no difference in follow-up mortality (HR, 1.02; p = .86).
CONCLUSIONS
Despite having patients with an increased baseline risk, ViV TAVR was associated with lower 30-day mortality, while Redo SAVR had lower paravalvular leak, severe patient-prosthesis mismatch, and postoperative gradients. Although ViV TAVR remains a feasible treatment option in high-risk patients, randomized trials are necessary to elucidate its efficacy over Redo SAVR.
Topics: Aortic Valve; Aortic Valve Stenosis; Bioprosthesis; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Reoperation; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 33797799
DOI: 10.1111/jocs.15546