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Heart (British Cardiac Society) Aug 2021The review aims to summarise evidence addressing patients' values, preferences and practical issues on deciding between transcatheter aortic valve insertion (TAVI) and...
The review aims to summarise evidence addressing patients' values, preferences and practical issues on deciding between transcatheter aortic valve insertion (TAVI) and surgical aortic valve replacement (SAVR) for aortic stenosis. We searched databases and grey literature until June 2020. We included studies of adults with aortic stenosis eliciting values and preferences about treatment, excluding medical management or palliative care. Qualitative findings were synthesised using thematic analysis, and quantitative findings were narratively described. Evidence certainty was assessed using CERQual (Confidence in the Evidence from Reviews of Qualitative Research) and GRADE (Grading of Recommendations Assessment, Development and Evaluation). We included eight studies. Findings ranged from low to very low certainty. Most studies only addressed TAVI. Studies addressing both TAVI and SAVR reported on factors affecting patients' decision-making along with treatment effectiveness, instead of trade-offs between procedures. Willingness to accept risk varied considerably. To improve their health status, participants were willing to accept higher mortality risk than current evidence suggests for either procedure. No study explicitly addressed valve reintervention, and one study reported variability in willingness to accept shorter duration of known effectiveness of TAVI compared with SAVR. The most common themes were desire for symptom relief and improved function. Participants preferred minimally invasive procedures with shorter hospital stay and recovery. The current body of evidence on patients' values, preferences and practical issues related to aortic stenosis management is of suboptimal rigour and reports widely disparate results regarding patients' perceptions. These findings emphasise the need for higher quality studies to inform clinical practice guidelines and the central importance of shared decision-making to individualise care fitted to each patient.
Topics: Aortic Valve Stenosis; Decision Making; Heart Valve Prosthesis Implantation; Humans; Patient Preference; Quality-Adjusted Life Years; Risk Adjustment; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 33563630
DOI: 10.1136/heartjnl-2020-318334 -
Heart Failure Reviews Jan 2024Tricuspid regurgitation (TR) is the most common valvular pathology after heart transplantation (HTx) and endomyocardial biopsy (EMB) remains responsible for the majority... (Review)
Review
Tricuspid regurgitation (TR) is the most common valvular pathology after heart transplantation (HTx) and endomyocardial biopsy (EMB) remains responsible for the majority of cases due to the high probability of structural valve damage. The aim of the present review was to describe the results of surgical management of severe tricuspid regurgitation through tricuspid valve replacement (TVR) after a previous HTx. A systematic review was conducted by searching Pubmed, ScienceDirect, SciELO, DOAJ, and Cochrane databases until June 2023 for publications reporting patients undergoing TVR surgery after a previous HTx. If no right heart valve surgery was undertaken, or a heterotopic heart transplant was performed, or if the concomitant procedure was performed during the transplant itself, the paper was excluded. Twenty articles met our inclusion criteria out of 1532 potentially eligible studies, with a total of 300 patients. Mean age was 55.1 ± 9.6 years, and 85.1% were male. The mean number of EMB per patient was 31.1 ± 5.5 with a mean time between HTx and TVR of 7.64 ± 3.31 years. Bioprostheses were used in 83.3% of cases and 75.0% of patients with a bioprosthesis were reported as alive at last follow-up. Tricuspid valve repair is a valuable option, but these patients will be susceptible to recurrent TR after EMB. TVR with a bioprosthesis may provide the optimal solution for this subset of patients, as EMB is not feasible with a mechanical valve.
Topics: Humans; Male; Middle Aged; Female; Tricuspid Valve Insufficiency; Tricuspid Valve; Treatment Outcome; Retrospective Studies; Heart Valve Prosthesis; Heart Transplantation; Heart Valve Prosthesis Implantation
PubMed: 37851119
DOI: 10.1007/s10741-023-10364-9 -
Journal of Cardiac Surgery Nov 2021Recent studies suggested higher rates of early structural valve degeneration or reintervention for the Trifecta valve compared to other valves. Thus, we conducted a... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Recent studies suggested higher rates of early structural valve degeneration or reintervention for the Trifecta valve compared to other valves. Thus, we conducted a systematic review and meta-analysis comparing the outcomes of the Trifecta valve and the Perimount valves in patients who underwent a surgical aortic valve replacement (SAVR).
METHODS
All randomized control trials and observational studies which investigated the outcomes of the Trifecta valve and Perimount valves were identified with PubMed and EMBASE. The endpoints were the rates of reintervention and all-cause mortality. Hazard ratios (HRs) for reintervention and all-cause mortality were combined with the random-effects model.
RESULTS
Our search identified 6 eligible observational studies which enrolled a total of 11,135 patients who underwent SAVR with either the Trifecta valve (n = 4932) or Perimount (n = 6203). Pooled analyses demonstrated that the reintervention rates were significantly higher with the Trifecta valve compared with Perimount valves (HR [95% confidence interval {CI}] = 3.16 [1.83-5.46]; p < .0001; I = 40%). In contrast, all-cause mortality was not significantly different between the two groups (HR [95% CI] = 1.09 [0.75-1.58]; p = .32, I = 12%).
CONCLUSION
Our analysis showed that AVR with the Trifecta valve was associated with higher rates of reintervention compared for that with the Perimount valve. Although further long-term randomized trials are warranted, surgeons need to be cautious when choosing a bioprosthetic valve for patients undergoing SAVR.
Topics: Aortic Valve; Aortic Valve Stenosis; Bioprosthesis; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Prosthesis Design; Retrospective Studies
PubMed: 34499386
DOI: 10.1111/jocs.15972 -
Hellenic Journal of Cardiology : HJC =... 2022The ACURATE neo transcatheter aortic valve is a self-expanding device suitable for both transfemoral and transapical approach, but specific groups of patients are... (Review)
Review
The ACURATE neo transcatheter aortic valve is a self-expanding device suitable for both transfemoral and transapical approach, but specific groups of patients are under-represented in clinical trials. We aim to provide a comprehensive systematic review on TAVI with ACURATE neo in those special populations. TAVI in bicuspid aortic valve, TAVI in patients with small aortic annulus, TAVI for pure aortic regurgitation and valve-in-valve procedures, were systematically reviewed. The primary endpoint was device success as defined by VARC-2 criteria. The secondary endpoints were safety and performance outcomes according to VARC-2 consensus document.ACURATE neo exhibited similar outcomes in bicuspid vs tricuspid aortic valve except for pre and post-dilatation rates in one observational study. Lower mean aortic gradient and higher pre-dilatation rates with comparable safety outcomes were described for ACURATE neo when compared to Lotus and Evolut-R for bicuspid aortic valve stenosis. 2 studies compared ACURATE in small aortic annuli. ACURATE neo showed lower transvalvular gradients and lower patient prosthesis mismatch rates compared to Sapien 3 and when compared to Evolut R/ Evolut PRO/ Portico, results were similar except for pre-dilatation rates. 3 studies investigated ACURATE neo for pure aortic regurgitation and one for valve-in-valve procedure and demonstrated safety and efficacy, with the exception of malposition events in patients designated for higher valve deployment in the valve-in-valve implantation study.ACURATE neo valve may be a feasible and safe option for patients with bicuspid anatomy, small aortic annulus, previously implanted bioprosthetic aortic valve and pure aortic regurgitation. REGISTRATION NUMBER: Available at https://osf.io/aus26 (DOI 10.17605/OSF.IO/AUS26).
Topics: Aortic Valve; Aortic Valve Insufficiency; Aortic Valve Stenosis; Bicuspid Aortic Valve Disease; Heart Valve Prosthesis; Humans; Observational Studies as Topic; Prosthesis Design; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 35508295
DOI: 10.1016/j.hjc.2022.04.005 -
Thrombosis Research Oct 2022To evaluate the safety and efficacy of perioperative bridging in patients with mechanical heart valves undergoing non-cardiac interventions. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To evaluate the safety and efficacy of perioperative bridging in patients with mechanical heart valves undergoing non-cardiac interventions.
MATERIALS AND METHODS
A systematic research using Medline, EMBASE, and Google Scholar was implemented corresponding to the Preferred Reporting Items for Systematic reviews and Meta-analysis (PRISMA) statement. Data from the eligible studies were obtained and meta-analyzed. Primary endpoints included major bleeding and thromboembolism. Secondary endpoints included minor bleeding, overall mortality, and overall bleeding (major and minor bleeding). We conducted a comparative analysis between bridging and non-bridging along with a sensitivity analysis for patients undergoing major and minor operations.
RESULTS
Fifteen studies comprised of 2305 patients (2453 bridging episodes) were included. Pooled major bleeding and thromboembolism rates were 3.85 % (95 % CI: 2.12-5.98) (I = 69 %, p < 0.01) and 0.39 % (95 % CI: 0.00-1.41) (I = 64 %, p < 0.01). Bridging versus non-bridging major bleeding, thromboembolism, and overall bleeding risk ratios (RR) were RR 2.05 (95 % CI: 0.98-4.28) (I = 10 %, p = 0.34), RR 1.63 (95 % CI: 0.41-6.50) (I = 0 %, p = 0.63) and RR 1.79 (95 % CI: 1.17-2.72) (I = 55 %, p = 0.09) respectively. Subgroup analysis displayed major and minor operation thromboembolism and overall bleeding rates of 3.09 % (95 % CI: 0.78-6.43) (I = 0 %, p = 0.89) versus 0.14 % (95 % CI: 0.00-1.40) (I = 0 %, p = 0.93), test for subgroup differences (p < 0.01) and 17.37 % (95 % CI: 11.73-23.77) (I = 0 %, p = 0.61) versus 28.18 % (95 % CI: 22.80-33.88) (I = 0 %, p = 0.47), test for subgroup differences (p = 0.01) respectively.
CONCLUSION
Our analysis suggests that bridging may potentially put patients at an increased bleeding risk regarding overall bleeding rates, while failing to provide statistically significant benefits concerning thromboembolism and overall mortality compared to non-bridging. Limitations such as the mixed patient population don't allow for definite conclusions to be drawn warrantying further research through randomized controlled trials.
Topics: Anticoagulants; Heart Valve Prosthesis; Heart Valves; Hemorrhage; Humans; Thromboembolism
PubMed: 36037548
DOI: 10.1016/j.thromres.2022.08.022 -
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 -
Cardiovascular Revascularization... Dec 2020The risk of prosthetic valve endocarditis (PVE) in patients who underwent transcatheter aortic valve replacement (TAVR) is presumed to be high. (Meta-Analysis)
Meta-Analysis
BACKGROUND
The risk of prosthetic valve endocarditis (PVE) in patients who underwent transcatheter aortic valve replacement (TAVR) is presumed to be high.
METHODS
Electronic databases were searched to identify articles comparing the rate of PVE in post-TAVR and post-surgical aortic valve replacement (SAVR) patients. Pooled adjusted odds ratio (OR) was computed using a random-effects model.
RESULTS
A total of 19 studies consisting of 84,288 patients, were identified. There was no significant difference in the odds of PVE between patients undergoing TAVR and SAVR, at 30-day (OR 0.62, 95% confidence interval (CI) 0.20-1.92, p = 0.41), 1-year (OR 0.99 95% CI 0.89-1.11, p = 0.84), 2-year (OR 1.02 95% CI 0.68-1.54, p = 0.92) and 5-year (OR 1.03 95% CI 0.80-1.33, p = 0.81). A subgroup sensitivity analysis also showed no significant inter-group differences in the rate of PVE at all time points, when stratified by the study design (clinical trial vs. observational), type of TAVR valves used (self-expanding bioprosthetic valves vs. balloon expanded bioprosthetic valves) and surgical risk of patients (high vs. intermediate vs. low). There was no heterogeneity (I2 = 0%) in the outcomes of the included studies at 30-day, 1-year and 2-year, while the heterogeneity in studies at 5-year was minimal (I2 = 22%).
CONCLUSIONS
In comparison to SAVR, both short and long-term risk of prosthetic valve endocarditis appears to be identical in patients undergoing TAVR. This risk is unaffected by the type of valve, duration of follow-up, study design and surgical risk of the patients.
Topics: Aortic Valve; Aortic Valve Stenosis; Endocarditis, Bacterial; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 32553850
DOI: 10.1016/j.carrev.2020.05.034 -
International Journal of Cardiology Oct 2020Surgical aortic valve replacement has been the treatment of choice for patients with aortic valve disease before the arrival of transcatheter aortic valve replacement... (Meta-Analysis)
Meta-Analysis
AIMS
Surgical aortic valve replacement has been the treatment of choice for patients with aortic valve disease before the arrival of transcatheter aortic valve replacement (TAVI), although limited by degeneration of the bioprosthesis. "Redo" intervention itself is burdened by high risk of complications and valve-in-valve (ViV) TAVI could be a valid strategy of redo for patients with comorbidities.
METHODS AND RESULTS
Two independent reviewers screened all studies investigating patients undergoing ViV TAVI. Mortality at 30 days and at 1 year was the primary end point. Of 286 studies identified, 26 articles were included in this review with a total of 1448 patients. Median age was 78.8 years, 57.7% male. Median STS score and Logistic EuroSCORE were 9.4% and 31.3% respectively. Stenosis (45%) was the leading cause of prosthesis failure. Transfemoral approach was preferred (76%), with a prevalence of balloon expandable valves (73.3%). Mean follow up was 376 days. Overall and cardiovascular mortality at 30 days was 6.5% and 5.5% respectively, while at 1 year it was 14.5% and 8.9% respectively. At meta-regression analysis study year (p < .001), Logistic EuroSCORE (p < .01) and valve diameter ≤ 21 mm (p < .05) at 30 days, and stenosis as reason for failure (p = .05) at 1 year were identified as possible predictors of survival.
CONCLUSIONS
ViV TAVI offers a valid strategy to treat high risk patients with a failure of bioprosthesis with satisfying results in terms of short and mid-term mortality. Future studies are needed to find predictors of long term survival and outcomes in lower risk patients.
Topics: Aged; Aortic Valve; Aortic Valve Stenosis; Bioprosthesis; Female; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Incidence; Male; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 32470529
DOI: 10.1016/j.ijcard.2020.05.058 -
Current Problems in Cardiology Jul 2023Transcatheter mitral valve replacement has become a useful alternative for patients with failed mitral prosthesis or annuloplasty rings who are deemed high risk for redo... (Meta-Analysis)
Meta-Analysis Review
Transcatheter mitral valve replacement has become a useful alternative for patients with failed mitral prosthesis or annuloplasty rings who are deemed high risk for redo surgery. We aimed to compare the clinical outcomes following transseptal (TS) and transapical (TA) approaches in transcatheter mitral valve-in-valve and valve-in-ring implantation (TMViV/R). Electronic databases PubMed, MEDLINE, and Embase were searched through November 2022. Both clinical trials and observational studies comparing patients undergoing TS and TA TMViV/R were eligible for inclusion. Primary outcomes were 30-day and 1-year mortality. Postoperative stroke, left ventricle outlet tract (LVOT) obstruction, mitral valve pressure gradient (MVPG), bleeding, and length of hospital stay were also evaluated. Seven observational studies were included comparing patients undergoing TS (n = 1875) and TA (n = 1120) TMViV/R. The TS group had significantly lower 30-day mortality (OR: 0.66; 95% confidence interval [CI] [0.47, 0.94]; P = 0.02, I² = 0%) and lower one-year mortality risk group (HR: 0.79; 95% CI [0.63, 0.99]; P = 0.04, I² = 0%) compared to the TA group. The TS group had consistent shorter in-hospital stay (MD = -3.79; 95% CI [-5.23, -2.34] days; P < 0.0001, I² = 75%). Postoperative stroke, bleeding and LVOT obstruction tended to be lower in the TS but the results did not reach statistical significance. Postoperative MVPG was similar between both groups. The TS approach has lower early mortality, lower 1-year death hazard, shorter in-hospital stay, and a trend toward lower complication rates when compared to TA TMViV/R. Further controlled trials may support the evidence and provide long-term outcomes.
Topics: Humans; Mitral Valve; Heart Valve Prosthesis Implantation; Treatment Outcome; Cardiac Catheterization; Mitral Valve Insufficiency; Heart Valve Prosthesis; Stroke
PubMed: 36921647
DOI: 10.1016/j.cpcardiol.2023.101684 -
Journal of Cardiothoracic Surgery Nov 2023The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve... (Review)
Review
BACKGROUND
The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve replacement. The need for consistent methodology in these early trials was highlighted by the observation of significant variability in the methods and protocols used across different research.
METHODS
An extensive search through six major databases was carried out to retrieve First-In-Human (FIH) clinical studies evaluating surgically implanted bio-prostheses in the mitral position.
RESULTS
Following the PRISMA guideline, a systematic search identified 2082 published articles until March 2023. After removing duplicates (189), 1862 citations were screened, resulting in 22 eligible studies with 3332 patients for analysis. The mitral valve prostheses in these studies ranged from 21 to 37 mm, with the 29 mm size being most prevalent. Patient numbers varied, with the FIH subgroup including 31 patients and the older subgroup including 163 patients. Average study durations differed: the older subgroup lasted 4.57 years, the FIH subgroup 2.85 years, and the early phase studies spanned 8.05 years on average.
CONCLUSION
FIH clinical report is essential to assess the significance of clinical data required for a "de novo" surgical implant. In addition, understanding the performance of the device, and recognizing the difficulties associated with the innovation constitute important lessons. These insights could be beneficial for the development of bioprosthetic heart valves and formulating a protocol for an FIH clinical trial.
Topics: Humans; Mitral Valve; Prosthesis Design; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Bioprosthesis; Prosthesis Failure
PubMed: 38037117
DOI: 10.1186/s13019-023-02464-2