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BMJ Open Dec 2021Patients undergoing surgery for severe aortic stenosis (SAS) can be treated with either transcatheter aortic valve implantation (TAVI) or surgical aortic valve... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Patients undergoing surgery for severe aortic stenosis (SAS) can be treated with either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). The choice of procedure depends on several factors, including the clinical judgement of the heart team and patient preferences, which are captured by actively informing and involving patients in a process of shared decision making (SDM). We synthesised the most up-to-date and accessible evidence on the benefits and risks that may be associated with TAVI versus SAVR to support SDM in this highly personalised decision-making process.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
MEDLINE (Ovid), Embase (Ovid) and the Cochrane Central Register of Controlled Trials (CENTRAL; Wiley) were searched from January 2000 to August 2020 with no language restrictions. Reference lists of included studies were searched to identify additional studies.
ELIGIBILITY CRITERIA
Randomised controlled trials (RCTs) that compared TAVI versus SAVR in patients with SAS and reported on all-cause or cardiovascular mortality, length of stay in intensive care unit or hospital, valve durability, rehospitalisation/reintervention, stroke (any stroke or major/disabling stroke), myocardial infarction, major vascular complications, major bleeding, permanent pacemaker (PPM) implantation, new-onset or worsening atrial fibrillation (NOW-AF), endocarditis, acute kidney injury (AKI), recovery time or pain were included.
DATA EXTRACTION AND SYNTHESIS
Two independent reviewers were involved in data extraction and risk of bias (ROB) assessment using the Cochrane tool (one reviewer extracted/assessed the data, and the second reviewer checked it). Dichotomous data were pooled using the Mantel-Haenszel method with random-effects to generate a risk ratio (RR) with 95% CI. Continuous data were pooled using the inverse-variance method with random-effects and expressed as a mean difference (MD) with 95% CI. Heterogeneity was assessed using the I statistic.
RESULTS
8969 records were retrieved and nine RCTs (61 records) were ultimately included (n=8818 participants). Two RCTs recruited high-risk patients, two RCTs recruited intermediate-risk patients, two RCTs recruited low-risk patients, one RCT recruited high-risk (≥70 years) or any-risk (≥80 years) patients; and two RCTs recruited all-risk or 'operable' patients. While there was no overall change in the risk of dying from any cause (30 day: RR 0.89, 95% CI 0.65 to 1.22; ≤1 year: RR 0.90, 95% CI 0.79 to 1.03; 5 years: RR 1.09, 95% CI 0.98 to 1.22), cardiovascular mortality (30 day: RR 1.03, 95% CI 0.77 to 1.39; ≤1 year: RR 0.90, 95% CI 0.76 to 1.06; 2 years: RR 0.96, 95% CI 0.83 to 1.12), or any type of stroke (30 day: RR 0.83, 95% CI 0.61 to 1.14;≤1 year: RR 0.94, 95% CI 0.72 to 1.23; 5 years: RR 1.07, 95% CI 0.88 to 1.30), the risk of several clinical outcomes was significantly decreased (major bleeding, AKI, NOW-AF) or significantly increased (major vascular complications, PPM implantation) for TAVI vs SAVR. TAVI was associated with a significantly shorter hospital stay vs SAVR (MD -3.08 days, 95% CI -4.86 to -1.29; 4 RCTs, n=2758 participants). Subgroup analysis generally favoured TAVI patients receiving implantation via the transfemoral (TF) route (vs non-TF); receiving a balloon-expandable (vs self-expanding) valve; and those at low-intermediate risk (vs high risk). All RCTs were rated at high ROB, predominantly due to lack of blinding and selective reporting.
CONCLUSIONS
No overall change in the risk of death from any cause or cardiovascular mortality was identified but 95% CIs were often wide, indicating uncertainty. TAVI may reduce the risk of certain side effects while SAVR may reduce the risk of others. Most long-term (5-year) results are limited to older patients at high surgical risk (ie, early trials), therefore more data are required for low risk populations. Ultimately, neither surgical technique was considered dominant, and these results suggest that every patient with SAS should be individually engaged in SDM to make evidence-based, personalised decisions around their care based on the various benefits and risks associated with each treatment.
PROSPERO REGISTRATION NUMBER
CRD42019138171.
Topics: Aortic Valve; Aortic Valve Stenosis; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 34873012
DOI: 10.1136/bmjopen-2021-054222 -
Hellenic Journal of Cardiology : HJC =... 2022Cardiac amyloidosis (CA) is an increasingly recognised condition in patients with aortic stenosis (AS). However, there is a large variation in the reported prevalence... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Cardiac amyloidosis (CA) is an increasingly recognised condition in patients with aortic stenosis (AS). However, there is a large variation in the reported prevalence figures, due to differences in populations and diagnostic methods. We aimed to investigate the prevalence, risk factors and outcomes of concomitant CA and AS.
METHODS
We performed a systematic review and meta-analysis of the literature searched on MEDLINE, Embase, Scopus and CENTRAL. We analysed the prevalence of CA in patients with AS grouped according to the diagnostic techniques, and the risk factors and outcomes of concomitant CA and AS were analysed in AS patients referred for surgical or transcatheter aortic valve replacement (AVR).
RESULTS
A total of 21 studies were included, involving 4,243 patients. The pooled prevalence of CA in patients with AS was 14.4%, with substantial heterogeneity. The pooled prevalence of AS in patients CA was 8.7%, with substantial heterogeneity. Patients with both AS and CA had higher all-cause mortality than those with AS or CA alone. In AS patients requiring AVR, CA was associated with increasing age, male sex, higher NT-proBNP levels, increased interventricular septal end diastole (IVSd) thickness and lower left ventricular ejection fraction. Concomitant AS and CA was associated with increased all-cause mortality and pacemaker implantation post-procedure. Study limitations included heterogeneity of the results and the fair to good quality of the studies published.
CONCLUSION
Overall, a substantial proportion of patients with AS may have CA, and they have poorer prognosis. A high degree of clinical suspicion is needed to identify the "red flags" and perform appropriate diagnostic imaging.
Topics: Amyloidosis; Aortic Valve; Aortic Valve Stenosis; Heart Valve Prosthesis Implantation; Humans; Male; Prevalence; Risk Factors; Stroke Volume; Transcatheter Aortic Valve Replacement; Treatment Outcome; Ventricular Function, Left
PubMed: 34856378
DOI: 10.1016/j.hjc.2021.11.001 -
Frontiers in Cardiovascular Medicine 2021Transcatheter aortic valve implantation (TAVI) has achieved satisfactory outcomes in the selected patients with bicuspid aortic valve (BAV), predominately type 1 BAV...
Transcatheter aortic valve implantation (TAVI) has achieved satisfactory outcomes in the selected patients with bicuspid aortic valve (BAV), predominately type 1 BAV (~90%). However, there are few reports about the safety and efficacy of TAVI in type 0 BAV. Therefore, in the current study, we aimed to compare procedural and 30-day outcomes after TAVI between type 0 and type 1 BAV. Studies comparing the outcomes of TAVI in Sievers type 0 vs. type 1 BAV were retrieved from PubMed, EMBASE, Cochrane Library, and Web of Science from inception to May 2021. The data were extracted regarding the study characteristics and outcomes. The odds ratios (ORs) with 95% CIs were pooled for procedural and 30-day outcomes. Six observational studies were included with determined type 0 BAV in 226 patients and type 1 BAV in 902 patients. The patients with type 0 BAV were slightly younger, had larger supra-annular structure, and more frequently implanted self-expanding prosthesis compared with type 1 BAV. In the pooled analyses, the patients with type 0 BAV had a similar incidence of procedural death (OR = 2.6, 95% CI 0.7-10.3), device success (OR = 0.6; 95% CI 0.3-1.3), and ≥ mild (OR = 0.8; 95% CI 0.4-1.6) or moderate (OR = 0.9, 95% CI 0.4-1.8) paravalvular leak, whereas significantly higher mean aortic gradient (mean difference = 1.4 mmHg, 95% CI 0.03-2.7) and increased coronary compromise risk (OR = 7.2; 95% CI 1.5-34.9), compared with type 1 BAV. Meanwhile, the incidence of death (OR = 1.2; 95% CI 0.5-3.1), stroke (OR = 0.5; 95% CI 0.1-2.4), and new pacemaker (OR = 0.6; 95% CI 0.2-2.2) at 30 days were not significantly different between the BAV morphologies ( > 0.05). The treatment effect heterogeneity across the studies for the above outcomes were low. The patients with type 0 BAV appear to have similar short-term outcomes after TAVI compared with type 1 BAV. Whereas, TAVI for type 0 BAV aortic stenosis might lead to an elevated coronary obstruction risk and suboptimal aortic valvular hemodynamics.
PubMed: 34805325
DOI: 10.3389/fcvm.2021.771789 -
Journal of Cardiothoracic Surgery Oct 2021Although transcatheter technology has achieved some success in the field of mitral valves, the feasibility of applying it to patients with degenerated mitral valve... (Meta-Analysis)
Meta-Analysis
Transcatheter mitral valve replacement for degenerated mitral valve bioprostheses, failure of mitral valvuloplasty and native valve with severe mitral annulus calcification: a systematic review and meta-analysis.
BACKGROUND
Although transcatheter technology has achieved some success in the field of mitral valves, the feasibility of applying it to patients with degenerated mitral valve bioprostheses (valve-in-valve, ViV), failure of mitral valvuloplasty (valve-in-ring, ViR) and serious mitral annulus calcification (vale-in-MAC, ViMAC) has not been effectively evaluated.
METHODS
By searching published literature before December 5, 2020 in four databases, we found all the literature related to the evaluation of feasibility assessment of TMViV, TMViR and TMViMAC. Outcomes focused on all-cause mortality within 30 days, bleeding and LVOT obstruction.
RESULTS
A total of six studies were included, and all of them were followed up for at least 30 days. After analysis of the ViV-ViR group, we obtained the following results: the all-cause mortality within 30 days of the ViV group was lower than that of the ViR group. Life-threatening or fatal bleeding was more likely to occur in the ViR group after surgery. At the same time, the ViR group was more prone to left ventricular outflow tract obstruction. However, in the ViMAC-ViR group, only the all-cause mortality within 30 days and stroke were statistically significant. In the indirect comparison, we found that TMViV had the best applicability, followed by TMViR. There were few TMViMAC available for analysis, and it requires further studies to improve the accuracy of the results.
CONCLUSION
TMViV and TMViR had good applicability and could benefit patients who underwent repeat valve surgery. The feasibility of TMViMAC needs to be further explored and improved.
Topics: Bioprosthesis; Cardiac Catheterization; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Mitral Valve; Mitral Valve Annuloplasty; Mitral Valve Insufficiency; Prosthesis Design; Treatment Outcome
PubMed: 34629106
DOI: 10.1186/s13019-021-01677-7 -
PloS One 2021In the last 25 years, numerous tissue engineered heart valve (TEHV) strategies have been studied in large animal models. To evaluate, qualify and summarize all available... (Meta-Analysis)
Meta-Analysis
In the last 25 years, numerous tissue engineered heart valve (TEHV) strategies have been studied in large animal models. To evaluate, qualify and summarize all available publications, we conducted a systematic review and meta-analysis. We identified 80 reports that studied TEHVs of synthetic or natural scaffolds in pulmonary position (n = 693 animals). We identified substantial heterogeneity in study designs, methods and outcomes. Most importantly, the quality assessment showed poor reporting in randomization and blinding strategies. Meta-analysis showed no differences in mortality and rate of valve regurgitation between different scaffolds or strategies. However, it revealed a higher transvalvular pressure gradient in synthetic scaffolds (11.6 mmHg; 95% CI, [7.31-15.89]) compared to natural scaffolds (4,67 mmHg; 95% CI, [3,94-5.39]; p = 0.003). These results should be interpreted with caution due to lack of a standardized control group, substantial study heterogeneity, and relatively low number of comparable studies in subgroup analyses. Based on this review, the most adequate scaffold model is still undefined. This review endorses that, to move the TEHV field forward and enable reliable comparisons, it is essential to define standardized methods and ways of reporting. This would greatly enhance the value of individual large animal studies.
Topics: Animals; Heart Valve Prosthesis; Models, Animal; Pulmonary Valve; Tissue Engineering
PubMed: 34610023
DOI: 10.1371/journal.pone.0258046 -
Kardiochirurgia I Torakochirurgia... Mar 2021For patients with heart valve replacement, self-management can play an essential role in the management of their condition.
INTRODUCTION
For patients with heart valve replacement, self-management can play an essential role in the management of their condition.
AIM
This review aimed to identify the aspects of self-management and its clinical outcomes in patients with heart valve replacement.
MATERIAL AND METHODS
In this systematic review, the peer-reviewed research literature on self-management of patients with heart valve replacement was assessed. Since May 2020, the PubMed, Scopus, and web of science databases were searched regardless of time and language limitations. The eligibility of the articles was assessed by title or abstract according to the search strategy. Article selection was applied regarding to inclusion and exclusion criteria. Also, article screening was conducted by 2 independent authors.
RESULTS
Twenty-five studies were considered in this systematic review. For inclusion, the self-management of patients had to have prerequisites, appropriate training, and be applicable in the aspects of anticoagulation therapy self-management, international normalized ratio (INR) self-testing, low-dose INR self-management, and heart valve function self-monitoring. In this method, through proper management of INR levels and anticoagulation therapy, the complications rate could be reduced and the patients would be able to diagnose functional disorders in the early stages by monitoring the valve function. This procedure was able to prevent the progression of complications.
CONCLUSIONS
Self-management is an applicable protocol in the field of anticoagulation therapy, INR control, low-dose INR management, and the monitoring of cardiac valve function. This protocol could improve the quality of treatment for these patients through upgrading the care standards.
PubMed: 34552643
DOI: 10.5114/kitp.2021.105186 -
Journal of the Saudi Heart Association 2021prosthetic valve endocarditis is a rare but a life-threatening complication of brucellosis. It remains a diagnostic challenge. Optimal treatment of prosthetic valve... (Review)
Review
OBJECTIVE
prosthetic valve endocarditis is a rare but a life-threatening complication of brucellosis. It remains a diagnostic challenge. Optimal treatment of prosthetic valve endocarditis is debated. Available data is limited to case reports or small case series. The purpose of this study was to systematically review all published cases of prosthetic valve endocarditis in the literature.
METHOD
A systematic review of PubMed database, Google, Google Scholar, and Scopus (From January 1974 to the present) for studies providing epidemiological, clinical and microbiological data as well as data on treatment and outcomes of prosthetic valve endocarditis was performed.
RESULTS
A total of 51 reported cases were reviewed. (45%) and (11.7%) were the most frequently isolated species. Most common type of prosthesis valve was mechanical prothesis (84.3%) and ten patients had double valve prosthesis (19.6%). Fever and dyspnea were present in 100% and 37.2% of the cases, respectively. The diagnosis was set with echocardiographic finding in 30 cases (93.7%), which revealed vegetation in 27 cases (84.3%). Most used antibiotics were rifampicin, doxycycline and aminoglycoside or cotrimoxazole. No deaths were noted in patients treated by combined medical and surgical treatment, but mortality was noted in 27.7% of the cases treated by antibiotics alone (p = 0.006).
CONCLUSION
This systematic review highlights diagnostic challenges and demonstrates that surgery improved outcome by reducing mortality in patients treated with the combined surgical and medical treatment option. Brucellosis should be considered in the differential diagnosis of prosthetic valve endocarditis in patients residing in or traveling to areas of endemicity.
PubMed: 34447668
DOI: 10.37616/2212-5043.1257 -
Frontiers in Cardiovascular Medicine 2021New antithrombotic drugs have been developed, new valve types have been designed and minimally invasive transcatheter techniques have emerged, making the choice of...
New antithrombotic drugs have been developed, new valve types have been designed and minimally invasive transcatheter techniques have emerged, making the choice of antithrombotic therapy after surgical or transcatheter heart valve repair and replacement increasingly complex. Moreover, due to a lack of large randomized controlled trials many recommendations for antithrombotic therapy are based on expert opinion, reflected by divergent recommendations in current guidelines. Therefore, decision-making in clinical practice regarding antithrombotic therapy for prosthetic heart valves is difficult, potentially resulting in sub-optimal patient treatment. This article compares the 2017 ESC/EACTS and 2020 ACC/AHA guidelines on the management of valvular heart disease and summarizes the available evidence. Finally, we established a convenient consensus on antithrombotic therapy after valve interventions based on over 800 annual cases of surgical and transcatheter heart valve repair and replacement and a multidisciplinary team discussion between the department of cardiovascular diseases and cardiac surgery of the University Hospitals Leuven, Belgium.
PubMed: 34422930
DOI: 10.3389/fcvm.2021.702780 -
Current Problems in Cardiology Oct 2022Paravalvular leak (PVL) is very common after TAVI and has been reported to have a negative impact on both short- and long-term survival. The current study identified...
Paravalvular Leak After Transcatheter Aortic Valve Implantation Its Incidence, Diagnosis, Clinical Implications, Prevention, Management, and Future Perspectives: A Review Article.
Paravalvular leak (PVL) is very common after TAVI and has been reported to have a negative impact on both short- and long-term survival. The current study identified incidence, diagnosis, clinical implications, and prevention, management and future perspectives for post-TAVI paravalvular leak. A systematic literature search was conducted using PubMed and EMBASE, using the MeSH terms and key words "paravalvular leak," "diagnostic criteria," "implication," "influencing factors," and "prevention strategies." Studies were retained for review after meeting strict inclusion criteria that included only prospective studies evaluating Paravalvular leak in patients who had TAVI. Thirty articles were selected for inclusion, incidence of PVL across the studies ranged from 7% to 40%. Many factors have been associated with incidence and increased risk of PVL, including AVC volume, larger annulus dimensions, pre-TAVI transvalvular peak velocity, under sizing of the prosthesis, surgical, and other factors. PVL after TAVI is common and can be predicted by aortic root calcification volume, larger annulus dimensions, and pre-TAVI transvalvular peak velocity, with calcification volume being an independent predictor for PVL. The strength and nature of the association of various degrees of post-TAVI PVL and mortality are still to be further evaluated.
Topics: Aortic Valve; Aortic Valve Insufficiency; Aortic Valve Stenosis; Heart Valve Prosthesis; Humans; Incidence; Prospective Studies; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 34364915
DOI: 10.1016/j.cpcardiol.2021.100957 -
Medicine Jul 2021Presently, transcatheter aortic valve replacement (TAVR) as an effective and convenient intervention has been adopted extensively for patients with severe aortic... (Meta-Analysis)
Meta-Analysis
Comparison of postprocedural new-onset atrial fibrillation between transcatheter and surgical aortic valve replacement: A systematic review and meta-analysis based on 16 randomized controlled trials.
BACKGROUND
Presently, transcatheter aortic valve replacement (TAVR) as an effective and convenient intervention has been adopted extensively for patients with severe aortic disease. However, after surgical aortic valve replacement (SAVR) and TAVR, the incidence of new-onset atrial fibrillation (NOAF) is prevalently found. This meta-analysis was designed to comprehensively compare the incidence of NOAF at different times after TAVR and SAVR for patients with severe aortic disease.
METHODS
A systematic search of PubMed, Embase, Cochrane Library, and Web of Science up to October 1, 2020 was conducted for relevant studies that comparing TAVR and SAVR in the treatment of severe aortic disease. The primary outcomes were the incidence of NOAF with early, midterm and long term follow-up. The secondary outcomes included permanent pacemaker (PM) implantation, myocardial infarction (MI), cardiogenic shock, as well as mortality and other complications. Two reviewers assessed trial quality and extracted the data independently. All statistical analyses were performed using the standard statistical procedures provided in Review Manager 5.2.
RESULTS
A total of 16 studies including 13,310 patients were identified. The pooled results indicated that, compared with SAVR, TAVR experienced a significantly lower incidence of 30-day/in-hospital, 1-year, 2-year, and 5-year NOAF, with pooled risk ratios (RRs) of 0.31 (95% confidence interval [CI] 0.23-0.41; 5725 pts), 0.30 (95% CI 0.24-0.39; 6321 pts), 0.48 (95% CI 0.38-0.61; 3441 pts), and 0.45 (95% CI 0.37-0.55; 2268 pts) respectively. In addition, TAVR showed lower incidence of MI (RR 0.62; 95% CI 0.40-0.97) and cardiogenic shock (RR 0.34; 95% CI 0.19-0.59), but higher incidence of permanent PM (RR 3.16; 95% CI 1.61-6.21) and major vascular complications (RR 2.22; 95% CI 1.14-4.32) at 30-day/in-hospital. At 1- and 2-year after procedure, compared with SAVR, TAVR experienced a significantly higher incidence of neurological events, transient ischemic attacks (TIA), permanent PM, and major vascular complications, respectively. At 5-year after procedure, compared with SAVR, TAVR experienced a significantly higher incidence of TIA and re-intervention respectively. There was no difference in 30-day, 1-year, 2-year, and 5-year all-cause or cardiovascular mortality as well as stroke between TAVR and SAVR.
CONCLUSIONS
Our analysis showed that TAVR was superior to SAVR in decreasing the both short and long term postprocedural NOAF. TAVR was equal to SAVR in early, midterm and long term mortality. In addition, TAVR showed lower incidence of 30-day/in-hospital MI and cardiogenic shock after procedure. However, pooled results showed that TAVR was inferior to SAVR in reducing permanent pacemaker implantation, neurological events, TIA, major vascular complications, and re-intervention.
Topics: Atrial Fibrillation; Heart Valve Prosthesis Implantation; Humans; Randomized Controlled Trials as Topic; Risk Factors; Severity of Illness Index; Time Factors; Transcatheter Aortic Valve Replacement
PubMed: 34260547
DOI: 10.1097/MD.0000000000026613