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EuroIntervention : Journal of EuroPCR... Nov 2022Transcatheter tricuspid valve replacement (TTVR) is rapidly emerging as a therapeutic option amongst patients with secondary tricuspid regurgitation. Historical data... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Transcatheter tricuspid valve replacement (TTVR) is rapidly emerging as a therapeutic option amongst patients with secondary tricuspid regurgitation. Historical data from surgical tricuspid valve replacement (TVR) studies may serve as a benchmark for the development of TTVR trials.
AIMS
The aim of the study was to investigate the early and late outcomes following isolated surgical TVR.
METHODS
Multiple electronic databases were searched to identify studies on isolated surgical TVR. The prespecified primary endpoint was operative mortality; secondary endpoints were early and late outcomes. Overall estimates of proportions and incidence rates with 95% confidence intervals (CI) were calculated using random-effects models. Multiple sensitivity analyses accounting for baseline characteristics, country and the operative period were applied. Results: A total of 35 studies (5,316 patients) were included in this meta-analysis. The operative period ranged from 1974 to 2019. The overall rate of operative mortality was 12% (95% CI: 9-15), with higher mortality for patients who were operated on before 1995, who had prior cardiac surgeries, or who had liver disease. The most frequent clinical events were pacemaker implantation (10% [95% CI: 6-16]), bleeding (12% [95% CI: 8-17]), acute kidney injury (15% [95% CI: 9-24]) and respiratory complications (15% [95% CI: 12-20]). At follow-up analysis of the bioprosthetic TVR, there was an incidence rate per 100 person-years of 6 (95% CI: 2-13) for death and 8 (95% CI: 5-13) for recurrence of significant tricuspid regurgitation.
CONCLUSIONS
This meta-analysis provides an overview of the historical clinical outcomes following isolated surgical TVR. These findings can support the development of future clinical trials in the tricuspid space by providing thresholds for clinical outcomes.
Topics: Humans; Tricuspid Valve Insufficiency; Tricuspid Valve; Heart Valve Prosthesis Implantation; Treatment Outcome; Heart Valve Prosthesis; Retrospective Studies
PubMed: 36197445
DOI: 10.4244/EIJ-D-22-00442 -
European Heart Journal. Quality of Care... Aug 2023Standardized data definitions are necessary for the quantification of quality of care and patient outcomes in observational studies and randomised controlled trials...
AIMS
Standardized data definitions are necessary for the quantification of quality of care and patient outcomes in observational studies and randomised controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology (ESC) aims to create pan-European data standards for cardiovascular diseases and interventions, including transcatheter aortic valve implantation (TAVI).
METHODS AND RESULTS
We followed the EuroHeart methodology for cardiovascular data standard development. A Working Group of 29 members representing 12 countries was established and included a patient representative, as well as experts in the management of valvular heart disease from the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Association of Cardiovascular Imaging (EACVI) and the Working Group on Cardiovascular Surgery. We conducted a systematic review of the literature and used a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition, permissible values, and categorized the variable as mandatory (Level 1) or additional (Level 2) based on its clinical importance and feasibility. In total, 93 Level 1 and 113 Level 2 variables were selected, with the level 1 variables providing the dataset for registration of patients undergoing TAVI on the EuroHeart IT platform.
CONCLUSION
This document provides details of the EuroHeart data standards for TAVI processes of care and in-hospital outcomes. In the context of EuroHeart, this will facilitate quality improvement, observational research, registry-based RCTs and post-marketing surveillance of devices, and pharmacotherapies.
ONE-SENTENCE SUMMARY
The EuroHeart data standards for transcatheter aortic valve implantation (TAVI) are a set of internationally agreed data variables and definitions that once implemented will facilitate improvement of quality of care and outcomes for patients receiving TAVI.
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve; Aortic Valve Stenosis; Heart Valve Prosthesis Implantation; Registries; Randomized Controlled Trials as Topic
PubMed: 36195332
DOI: 10.1093/ehjqcco/qcac063 -
Scandinavian Journal of Surgery : SJS :... Dec 2022The published literature investigating the impact of sex on outcomes after mitral valve (MV) surgery has demonstrated inferior outcomes for females over males. However,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND OBJECTIVE
The published literature investigating the impact of sex on outcomes after mitral valve (MV) surgery has demonstrated inferior outcomes for females over males. However, the true relationship between sex and outcomes after MV surgery continues to be poorly understood.
MATERIALS
PubMed, Medline, and Embase were systematically searched for articles published from 1 January 2005 to 1 August 2021. This systematic review included retrospective and prospective studies investigating the relationship between sex and outcomes after MV surgery. In all, 2068 articles were initially screened and 12 studies were included in this review.
RESULTS
Few studies were adequately powered or structured to investigate this topic. Few studies propensity matched patients or isolated for surgical approach. In individual studies, females experienced increased rates of short-term and long-term mortality and increased 1-year mortality in the pooled data. Males experienced increased rates of required pacemaker insertion. The remaining rates of morbidity and mortality did not differ significantly between males and females.
CONCLUSIONS
This review identified increased rates of 1-year mortality in the pooled data for females, while males had increased rates of pacemaker insertion. Despite this, the absence of propensity matching and isolating for surgical approach has introduced confounding variables that impair the ability of the included studies to interpret the results found in the current literature. Studies isolating for surgical approach, propensity matching patients, and examining outcomes with long-term follow-up are required to elucidate the true nature of this relationship.
Topics: Male; Female; Humans; Mitral Valve; Heart Valve Prosthesis Implantation; Retrospective Studies; Prospective Studies; Cardiac Surgical Procedures; Treatment Outcome
PubMed: 36112913
DOI: 10.1177/14574969221124468 -
Journal of Clinical Medicine Aug 2022spp. are non-motile, facultative anaerobic, Gram-negative coccobacilli that are commonly found in the oral cavity and the gastrointestinal tract of some animals and are... (Review)
Review
spp. are non-motile, facultative anaerobic, Gram-negative coccobacilli that are commonly found in the oral cavity and the gastrointestinal tract of some animals and are known to be the cause of infections. Usually, infections by spp. in humans is more common in the context of an animal bite leading to a skin and soft tissue infection (SSTI). Infective endocarditis (IE) is rarely caused by spp.; however, it can pose diagnostic and therapeutic dilemmas due to its rarity. The aim of the present study was to systematically review all cases of IE by spp. in the literature. A systematic review was performed of PubMed, Scopus and the Cochrane Library (through 20 December 2021) for studies providing data on epidemiology and clinical and microbiological characteristics as well as data on treatment and outcomes of IE by spp. A total of 28 studies containing data for 28 patients were included. Prosthetic valve was present in 21.4% of patients. The aorta was the most commonly involved intracardiac site. Fever, sepsis, septic shock and heart failure were the most common clinical presentations. Cephalosporins, aminopenicillins and penicillin were the antimicrobials used most commonly. Overall mortality was 17.9%.
PubMed: 36078964
DOI: 10.3390/jcm11175037 -
Biomedical Engineering Online Sep 2022Recently, transcatheter aortic valve replacement (TAVR) has been suggested as a less invasive treatment compared to surgical aortic valve replacement, for patients with... (Review)
Review
BACKGROUND
Recently, transcatheter aortic valve replacement (TAVR) has been suggested as a less invasive treatment compared to surgical aortic valve replacement, for patients with severe aortic stenosis. Despite the attention, persisting evidence suggests that several procedural complications are more prevalent with the transcatheter approach. Consequently, a systematic review was undertaken to evaluate the application of three-dimensional (3D) printing in preoperative planning for TAVR, as a means of predicting and subsequently, reducing the incidence of adverse events.
METHODS
MEDLINE, Web of Science and Embase were searched to identify studies that utilised patient-specific 3D printed models to predict or mitigate the risk of procedural complications.
RESULTS
13 of 219 papers met the inclusion criteria of this review. The eligible studies have shown that 3D printing has most commonly been used to predict the occurrence and severity of paravalvular regurgitation, with relatively high accuracy. Studies have also explored the usefulness of 3D printed anatomical models in reducing the incidence of coronary artery obstruction, new-onset conduction disturbance and aortic annular rapture.
CONCLUSION
Patient-specific 3D models can be used in pre-procedural planning for challenging cases, to help deliver personalised treatment. However, the application of 3D printing is not recommended for routine clinical practice, due to practicality issues.
Topics: Aortic Valve; Aortic Valve Stenosis; Heart Valve Prosthesis; Humans; Printing, Three-Dimensional; Risk Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 36050722
DOI: 10.1186/s12938-022-01029-z -
Journal of Cardiac Surgery Nov 2022Postoperative acute kidney injury (AKI) and the requirement for renal replacement therapy (RRT) remain common and significant complications of both transcatheter... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Postoperative acute kidney injury (AKI) and the requirement for renal replacement therapy (RRT) remain common and significant complications of both transcatheter valve-in-valve aortic valve replacement (ViV-TAVR) and redo surgical aortic valve replacement (SAVR). Nevertheless, the understanding of renal outcomes in the population undergoing either redo SAVR or ViV-TAVR remains controversial.
METHODS
A systematic database search with meta-analysis was conducted of comparative original articles of ViV-TAVR versus redo SAVR in EMBASE, MEDLINE, Cochrane database, and Google Scholar, from inception to September 2021. Primary outcomes were AKI and RRT. Secondary outcomes were stroke, major bleeding, pacemaker implantation rate, operative mortality, and 30-day mortality.
RESULTS
Our search yielded 5435 relevant studies. Eighteen studies met the inclusion criteria with a total of 11,198 patients. We found ViV-TAVR to be associated with lower rates of AKI, postoperative RRT, major bleeding, pacemaker implantation, operative mortality, and 30-day mortality. No significant difference was observed in terms of stroke rate. The mean incidence of AKI in ViV-TAVR was 6.95% (±6%) and in redo SAVR was 15.2% (±9.6%). For RRT, our data showed that VIV-TAVR to be 1.48% (±1.46%) and redo SAVR to be 8.54% (±8.06%).
CONCLUSION
Renoprotective strategies should be put into place to prevent and reduce AKI incidence regardless of the treatment modality. Patients undergoing re-intervention for the aortic valve constitute a high-risk and frail population in which ViV-TAVR demonstrated it might be a feasible option for carefully selected patients. Long-term follow-up data and randomized control trials will be needed to evaluate mortality and morbidity outcomes between these 2 treatments.
Topics: Acute Kidney Injury; Aortic Valve; Aortic Valve Stenosis; Heart Valve Prosthesis Implantation; Humans; Reoperation; Risk Factors; Stroke; Transcatheter Aortic Valve Replacement; Treatment Outcome
PubMed: 36040611
DOI: 10.1111/jocs.16890 -
The Permanente Journal Sep 2022IntroductionTakayasu's arteritis (TA) is an inflammatory condition that affects large vessels and frequently involves the aortic valve causing valve regurgitation.... (Review)
Review
IntroductionTakayasu's arteritis (TA) is an inflammatory condition that affects large vessels and frequently involves the aortic valve causing valve regurgitation. Surgical management is recommended for symptomatic severe aortic regurgitation (AR); however, the optimal surgical approach is yet unclear. This study aims to review surgical treatment options for AR in TA and determine which procedure has a lower chance of late postoperative events and/or mortality. MethodsAn electronic database search was performed within PubMed, EMBASE, Web of Science, and SCOPUS to identify articles from 1975 to 2016 focusing on surgical management of the AR in TA. ResultsTwenty seven studies encompassing a total of 194 cases (77% females) were included. Isolated aortic valve replacement (AVR) was performed in 105/194 cases (54%) (Group A), while combined aortic valve and root replacement (CAVRR) was performed in 87/194 (45%) (Group B). Prosthetic valve detachment was reported in 10/105 cases (9.5%) in group A and 1/87 cases (1.2%) in group B (p = 0.02). Dilation of the residual aorta was reported in 10/105 cases (9.5%) in group A and 1/87 cases (1.2%) in group B (p = 0.02). Any late (≥ 30 d) postoperative cardiac event was reported in 26/105 cases (24.8%) in group A, and in 7/87 cases (8.1%) in group B (p = 0.003). ConclusionsAlthough CAVRR is a more complex procedure, it might offer a better outcome in terms of late postoperative cardiac events compared to isolated AVR procedure. Future prospective studies are required to help determine the best surgical approach in such a population.
Topics: Aortic Valve; Aortic Valve Insufficiency; Female; Heart Valve Prosthesis Implantation; Humans; Male; Takayasu Arteritis
PubMed: 35939573
DOI: 10.7812/TPP/21.017 -
Canadian Journal of Surgery. Journal... 2022Many patients with end-stage kidney disease (ESKD) have valvular heart disease requiring surgery. The optimal prosthetic valve is not established in this population. We... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Many patients with end-stage kidney disease (ESKD) have valvular heart disease requiring surgery. The optimal prosthetic valve is not established in this population. We performed a systematic review and meta-analysis to assess outcomes of patients with dialysis-dependent ESKD who received mechanical or bioprosthetic valves.
METHODS
We searched Cochrane Central, Medline and Embase from inception to January 2020. We performed screening, full-text assessment, risk of bias and data collection, independently and in duplicate. Data were pooled using a random-effects model.
RESULTS
We identified 28 observational studies ( = 9857 patients, including 6680 with mechanical valves and 3717 with bioprosthetic valves) with a median follow-up of 3.45 years. Twenty-two studies were at high risk of bias and 1 was at critical risk of bias from confounding. Certainty in evidence was very low for all outcomes except bleeding. Mechanical valves were associated with reduced mortality at 30 days (relative risk [RR] 0.79, 95% confidence interval [CI] 0.65-0.97, = 0, absolute effect 27 fewer deaths per 1000) and at 6 or more years (mean 9.7 yr, RR 0.83, 95% CI 0.72-0.96, = 79%, absolute effect 145 fewer deaths per 1000), but increased bleeding (incidence rate ratio [IRR] 2.46, 95% CI 1.41-4.27, = 59%, absolute effect 91 more events per 1000) and stroke (IRR 1.63, 95% CI 1.21-2.20, = 0%, absolute effect 25 more events per 1000).
CONCLUSION
Mechanical valves were associated with reduced mortality, but increased rate of bleeding and stroke. Given very low certainty for evidence of mortality and stroke outcomes, patients and clinicians may choose prosthetic valves based on factors such as bleeding risk and valve longevity.
STUDY REGISTRATION
PROSPERO no. CRD42017081863.
Topics: Bioprosthesis; Heart Valve Diseases; Heart Valve Prosthesis; Hemorrhage; Humans; Renal Dialysis; Stroke
PubMed: 35820696
DOI: 10.1503/cjs.001121 -
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 -
ESC Heart Failure Oct 2022Randomized controlled trials comparing the use of the MitraClip device in addition to guideline directed medical therapy (GDMT) to GDMT alone in patients with secondary... (Meta-Analysis)
Meta-Analysis
AIM
Randomized controlled trials comparing the use of the MitraClip device in addition to guideline directed medical therapy (GDMT) to GDMT alone in patients with secondary mitral regurgitation (MR) have shown conflicting results. However, if these differences could be due to the underlying MR aetiology is still unknown. Therefore, we aimed to evaluate if the effects of percutaneous edge-to-edge repair with MitraClip implantation could differ in patients with ischaemic (I-MR) and non-ischaemic mitral regurgitation (NI-MR).
METHODS AND RESULTS
PubMed, Embase, BioMed Central, and the Cochrane Central Register of Controlled Trials were searched for all studies including patients with secondary MR treated with the MitraClip device. Data were pooled using a random-effects model. Primary endpoint was the composite of all-cause death and heart failure-related hospitalization. Secondary endpoints were the single components of the primary endpoint, New York Heart Association functional Classes III and IV, and mitral valve re-intervention. Seven studies enrolling 2501 patients were included. Patients with I-MR compared with patients with NI-MR had a similar risk of the primary endpoint (odds ratio: 1.17; 95% confidence interval: 0.93 to 1.46; I : 0%). The risk of all-cause death was increased in patients with I-MR (odds ratio: 1.31; 95% confidence interval: 1.07 to 1.62; I : 0%), while no differences were observed between the two groups in terms of the other secondary endpoints.
CONCLUSIONS
The risk of mortality after MitraClip implantation is lower in patients with NI-MR than in those with I-MR. No absolute differences in the risk of heart failure related hospitalization were observed between groups.
Topics: Humans; Mitral Valve Insufficiency; Heart Valve Prosthesis Implantation; Treatment Outcome; Mitral Valve; Heart Failure
PubMed: 35770326
DOI: 10.1002/ehf2.13772