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Cardiology and Therapy Jun 2023We aimed to systematically analyze the literature on the use of transcatheter aortic valve replacement (TAVR) to treat active aortic valve infective endocarditis... (Review)
Review
We aimed to systematically analyze the literature on the use of transcatheter aortic valve replacement (TAVR) to treat active aortic valve infective endocarditis (AV-IE). Surgery is declined in one-third of patients with IE who meet indications because of prohibitive surgical risk. TAVR might be an alternative for selected patients with AV-IE as a bridge-to-surgery or stand-alone therapy. PubMed/MEDLINE, Embase, and Cochrane databases were searched (2002-2022) for studies on TAVR use in active AV-IE. Of 450 identified reports, six met inclusion criteria (all men, mean age 71 ± 12 years, median Society of Thoracic Surgeons (STS) score 27, EuroSCORE 56). All patients were prohibitive surgical risk candidates. Five out of six patients had severe, and one patient had moderate aortic regurgitation on presentation. Five out of six patients had prosthetic valve endocarditis after surgical valve replacement 13 years before (median), and one patient had TAVR a year before hospitalization. All patients had cardiogenic shock as the indication for TAVR. Four patients received balloon-expanding, and two patients received self-expanding TAVR after a median of 19 (IQR 9-25) days from diagnosis of IE. No death or myocardial infarction occurred, but one patient had a stroke within the first 30 days. The median event-free time was 9 (IQR 6-14) months including no death, reinfection, relapse IE, or valve-related rehospitalization. Our review suggests that TAVR can be considered as an adjuvant therapy to medical treatment for selected patients in whom surgery is indicated for treatment of acute heart failure due to aortic valve destruction and incompetence caused by infective endocarditis, but who have a prohibitive surgical risk. Nonetheless, a well-designed prospective registry is urgently needed to investigate the outcomes of TAVR for this off-label indication. No evidence exists for using the TAVR to treat infection-related surgical indications such as uncontrolled infection or control of septic embolization.
PubMed: 37079182
DOI: 10.1007/s40119-023-00314-9 -
Journal of Cardiothoracic Surgery Apr 2023New technologies for the treatment of Aortic Stenosis are evolving to minimize risk and treat an increasingly comorbid population. The Sutureless Perceval Valve is one... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
New technologies for the treatment of Aortic Stenosis are evolving to minimize risk and treat an increasingly comorbid population. The Sutureless Perceval Valve is one such alternative. Whilst short-term data is promising, limited mid-term outcomes exist, until now. This is the first systematic review and meta-analysis to evaluate mid-term outcomes in the Perceval Valve in isolation.
METHODS
A systematic literature review of 5 databases was performed. Articles included evaluated echocardiographic and mortality outcomes beyond 5 years in patients who had undergone Perceval Valve AVR. Two reviewers extracted and reviewed the articles. Weighted estimates were performed for all post-operative and mid-term data. Aggregated Kaplan Meier curves were reconstructed from digitised images to evaluate long-term survival.
RESULTS
Seven observational studies were identified, with a total number of 3196 patients analysed. 30-day mortality was 2.5%. Aggregated survival at 1, 2, 3, 4 and 5 years was 93.4%, 89.4%, 84.9%, 82% and 79.5% respectively. Permanent pacemaker implantation (7.9%), severe paravalvular leak (1.6%), structural valve deterioration (1.5%), stroke (4.4%), endocarditis (1.6%) and valve explant (2.3%) were acceptable at up to mid-term follow up. Haemodynamics were also acceptable at up mid-term with mean-valve gradient (range 9-13.6 mmHg), peak-valve gradient (17.8-22.3 mmHg) and effective orifice area (1.5-1.8 cm) across all valve sizes. Cardiopulmonary bypass (78 min) and Aortic cross clamp times (52 min) were also favourable.
CONCLUSION
To our knowledge, this represents the first meta-analysis to date evaluating mid-term outcomes in the Perceval Valve in isolation and demonstrates good 5-year mortality, haemodynamic and morbidity outcomes.
KEY QUESTION
What are the mid-term outcomes at up to 5 years follow up in Perceval Valve Aortic Valve Replacement?
KEY FINDINGS
Perceval Valve AVR achieves 80% freedom from mortality at 5 years with low valve gradients and minimal morbidity.
KEY OUTCOMES
Perceval Valve Aortic Valve Replacement has acceptable mid-term mortality, durability and haemodynamic outcomes.
Topics: Humans; Heart Valve Prosthesis Implantation; Follow-Up Studies; Heart Valve Prosthesis; Aortic Valve; Aortic Valve Stenosis
PubMed: 37041628
DOI: 10.1186/s13019-023-02273-7 -
Journal of Cardiology Jul 2023Although the current guidelines advocate imaging surveillance for moderate aortic stenosis (AS), recent studies suggest a worse prognosis associated with moderate AS... (Meta-Analysis)
Meta-Analysis Review
Although the current guidelines advocate imaging surveillance for moderate aortic stenosis (AS), recent studies suggest a worse prognosis associated with moderate AS than previously reported. Considering the recent paradigm shift in AS management, the risk/benefit profile of aortic valve replacement (AVR) for moderate AS needs to be re-evaluated. Herein, we conducted meta-analyses of natural history and risk predictors in patients with moderate AS. PubMed and EMBASE were searched through May 2022 to identify studies that investigated the natural history of patients with moderate AS. Meta-analyses with random effects model were conducted. Our analysis included 20 observational studies which enrolled a total of 11,114 patients with moderate AS. The rate of all-cause death was 11.0 [95 % confidence interval (CI), 7.6-14.4] per 100 patients per year. Surgical or transcatheter AVR occurred at a rate of 8.5 (95 % CI, 6.2-10.8; I, 98.9 %) per 100 patients per year. Occurrence of AVR during follow-up [hazard ratio (HR) (95 % CI) = 0.56 (0.42-0.75), p < 0.001] and early AVR for moderate AS [HR (95 % CI) = 0.47 (0.25-0.90), p = 0.02] were associated with significantly lower all-cause mortality, while left ventricular ejection fraction <50 % [HR (95 % CI) = 1.84 (1.33-2.57), p = 0.0003] and symptomatic status [HR (95 % CI) = 1.52 (1.32-1.75), p < 0.0001] were associated with increased all-cause mortality. Sex difference was not related to all-cause mortality. Our meta-analysis suggested that moderate AS was associated with high mortality, especially in low left ventricular systolic function or symptomatic patients. In addition, significant portion of the patients underwent AVR during follow-up.
Topics: Humans; Stroke Volume; Ventricular Function, Left; Aortic Valve Stenosis; Aortic Valve; Transcatheter Aortic Valve Replacement; Heart Valve Prosthesis Implantation; Treatment Outcome; Risk Factors; Observational Studies as Topic
PubMed: 36963660
DOI: 10.1016/j.jjcc.2023.03.008 -
American Heart Journal Jul 2023The use of F-FDG PET/CT in diagnostic algorithms for PVE has increased since publication of studies and guidelines advocating its use. The assessment of test accuracy... (Meta-Analysis)
Meta-Analysis Review
IMPORTANCE
The use of F-FDG PET/CT in diagnostic algorithms for PVE has increased since publication of studies and guidelines advocating its use. The assessment of test accuracy has been limited by small study sizes. We undertook a systematic review using individual patient data (IPD) meta-analysis techniques.
OBJECTIVE
To estimate the summary sensitivity and specificity of F-FDG PET/CT in diagnosing PVE. We also assessed the effect of patient factors on test accuracy as defined by changes in the odds ratios associated with each factor. The effect of the PET/CT study on the final diagnosis was also assessed when compared to the preliminary Duke classification to determine in which patient group F-FDG PET/CT had the greatest utility.
STUDY SELECTION
Studies were included if PET/CT was performed for suspicion of PVE and IPD of both the PET/CT result and final diagnosis defined by a gold-standard assessment was available. There were 3 possible final diagnoses ("definite PVE," "possible PVE," and "rejected PVE").
RESULTS
Seventeen studies were included with IPD available for 537 patients (from 538 scans). The summary sensitivity and specificity were 85% (95% CI 74.2%-91.8%) and 86.5% (95% CI 75.8%-92.9%) respectively when patients with final diagnosis of "possible PVE" were classified as positive for PVE. When this group was classified as negative for PVE, sensitivity was 87.4% (95% CI 80.4%-92.1%) and specificity was 84.9% (95% CI 71.5%-92.6%). Patients with a known pathogen (especially coagulase negative staphylococcal species), elevated CRP, a biological or aortic valve infection appeared more likely to have an accurate PET/CT diagnosis. Those with a mechanical valve, prior antibiotic treatment or a transcatheter aortic valve replacement valve were less likely to have an accurate test. Time since valve implantation and the presence of surgical adhesive did not appear to affect test accuracy. Of the patients with a preliminary Duke classification of "possible PVE," 84% received a more conclusive final diagnosis of "definite" or "rejected" PVE after the PET/CT study.
CONCLUSIONS AND RELEVANCE
F-FDG PET/CT has high sensitivity and specificity in diagnosing PVE and the diagnostic utility is greatest in patients with a preliminary Duke classification of "possible PVE." Some patient factors appear to affect test accuracy, though these results should be interpreted with caution given low patient numbers for subgroup analyses.
Topics: Humans; Positron Emission Tomography Computed Tomography; Fluorodeoxyglucose F18; Endocarditis, Bacterial; Heart Valve Prosthesis; Endocarditis; Sensitivity and Specificity; Radiopharmaceuticals
PubMed: 36934977
DOI: 10.1016/j.ahj.2023.03.004 -
Current Problems in Cardiology Aug 2023The safety and clinical outcomes of transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR) among patients with solid organ... (Meta-Analysis)
Meta-Analysis Review
The safety and clinical outcomes of transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR) among patients with solid organ transplants is not well understood. This study aimed to evaluate the clinical outcomes of TAVR and SAVR among patients with a history of solid organ transplantation. We performed a systematic literature search of databases for relevant articles from inception until May 1st, 2022. Unadjusted odds ratios (OR) were pooled using a random-effect model, and a P-value of <0.05 was considered statistically significant. A total of 3240 studies were identified of which 3 studies with a total of 2960 patients were included in the final analysis. For solid organ transplants patients, the odds of in-hospital mortality (OR 0.37, 95% CI 0.20-0.71, P < 0.001), 30-day mortality (OR 0.51, 95% CI 0.35-0.74, P < 0.001), acute kidney injury (OR 0.45, 95% CI 0.35-0.59, P < 0.001), and bleeding (OR 0.35, 95% CI 0.27-0.46, P < 0.001) were significantly lower in patients undergoing TAVR compared to SAVR. In contrast, the odds of pacemaker implantation (OR 2.60, 95% CI 0.36-18.90, P = 0.34), postprocedural stroke (OR 0.36, 95% CI 0.13-1.03, P = 0.06) were similar between both groups of patients. Length of hospital stay was significantly lower in TAVR compared to SAVR patients (SMD -0.82, 95% CI -0.95 to -0.70, P < 0.001). In solid organ transplant patients, TAVR appeared to be a safe procedure with fewer postprocedure complications, shorter length of hospital stay, and lower in hospital mortality compared with SAVR.
Topics: Humans; Aortic Valve; Aortic Valve Stenosis; Risk Factors; Treatment Outcome; Transcatheter Aortic Valve Replacement; Heart Valve Prosthesis Implantation; Organ Transplantation
PubMed: 36931333
DOI: 10.1016/j.cpcardiol.2023.101685 -
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 -
International Journal of Environmental... Feb 2023Transcatheter aortic valve implantation (TAVI) has become a broadly acceptable alternative to AV surgery in patients with aortic stenosis (AS). New valve designs are... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Transcatheter aortic valve implantation (TAVI) has become a broadly acceptable alternative to AV surgery in patients with aortic stenosis (AS). New valve designs are becoming available to address the shortcomings of their predecessors and improve clinical outcomes.
METHODS
A systematic review and meta-analysis was carried out to compare Medtronic's Evolut PRO, a new valve, with the previous Evolut R design. Procedural, functional and clinical endpoints according to the VARC-2 criteria were assessed.
RESULTS
Eleven observational studies involving N = 12,363 patients were included. Evolut PRO patients differed regarding age ( < 0.001), sex ( < 0.001) and STS-PROM estimated risk. There was no difference between the two devices in terms of TAVI-related early complications and clinical endpoints. A 35% reduction of the risk of moderate-to-severe paravalvular leak (PVL) favoring the Evolut PRO was observed (RR 0.66, 95%CI, [0.52, 0.86] = 0.002; = 0%). Similarly, Evolut PRO-treated patients demonstrated a reduction of over 35% in the risk of serious bleeding as compared with the Evolut R (RR 0.63, 95%CI, [0.41, 0.96]; = 0.03; = 39%), without differences in major vascular complications.
CONCLUSIONS
The evidence shows good short-term outcomes of both the Evolut PRO and Evolut R prostheses, with no differences in clinical and procedural endpoints. The Evolut PRO was associated with a lower rate of moderate-to-severe PVL and major bleeding.
Topics: Humans; Transcatheter Aortic Valve Replacement; Prosthesis Design; Postoperative Complications; Treatment Outcome; Aortic Valve Stenosis; Hemorrhage; Risk Factors
PubMed: 36834131
DOI: 10.3390/ijerph20043439 -
Journal of Cardiothoracic Surgery Feb 2023Concomitant tricuspid repair in MR surgery is indicated in patients with severa tricuspid regurgitation, however, concomitant repair in less-than-severe TR patients is... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Concomitant tricuspid repair in MR surgery is indicated in patients with severa tricuspid regurgitation, however, concomitant repair in less-than-severe TR patients is still a matter of debate.
METHODS
In December 2021, we systematically searched PubMed, Embase and Cochrane databases for randomised control trials (RCTs) comparing isolated MR surgery versus MR surgery with concomitant TR annuloplasty. Four studies were included, resulting in 651 patients (323 in the prophylactic tricuspid intervention group and 328 in the no tricuspid intervention group).
RESULTS
Our meta-analysis showed a similar all-cause mortality and perioperative mortality for concomitant prophylactic tricuspid repair when compared with no tricuspid intervention (pooled odds ratio (OR), 0.54; 95% confidence interval (CI): 0.25-1.15, P = 0.11; I = 0% and pooled OR, 0.54; 95% CI: 0.25-1.15, P = 0.11; I = 0%, respectively) in patients undergoing MV surgery. despite a significantly lower TR progression (pooled OR, 0.06; 95% CI: 0.02-0.24, P < 0.01; I = 0%). Additionally, similar New York Heart Association (NYHA) classes III and IV were identified in both concomitant prophylactic tricuspid repair and no tricuspid intervention, despite a lower trend in the tricuspid intervention group (pooled OR, 0.63; 95% CI: 0.38-1.06, P = 0.08; I = 0%).
CONCLUSIONS
Our pooled analyses suggested that TV repair at the time of MV surgery in patients with moderate or less-than-moderate TR did not impact on perioperative or postoperative all-cause mortality, despite reducing TR severity and TR progression following the intervention.
Topics: Humans; Mitral Valve Insufficiency; Heart Valve Prosthesis Implantation; Treatment Outcome; Retrospective Studies; Mitral Valve; Tricuspid Valve Insufficiency
PubMed: 36803532
DOI: 10.1186/s13019-023-02158-9 -
Cardiology in ReviewIn recent years, minimally invasive cardiac surgery has increased in prevalence. There has been significant debate regarding the optimal approach to isolated aortic... (Meta-Analysis)
Meta-Analysis
In recent years, minimally invasive cardiac surgery has increased in prevalence. There has been significant debate regarding the optimal approach to isolated aortic valve replacement between conventional midline sternotomy and minimally invasive approaches. We performed a systematic review of the contemporary literature comparing minimally invasive to full sternotomy aortic valve replacement. PubMed and Embase were systematically searched for articles published from 2010-2021. A total of 1215 studies were screened and 45 studies (148,606 patients total) met the inclusion criteria. This study found rates of in-hospital mortality were higher with full sternotomy than ministernotomy ( P = 0.02). 30-day mortality was higher with full sternotomy compared to right anterior thoracotomy ( P = 0.006). Renal complications were more common with full sternotomy versus ministernotomy ( P < 0.00001) and right anterior thoracotomy ( P < 0.0001). Rates of wound infections were greater with full sternotomy than ministernotomy ( P = 0.02) and right anterior thoracotomy ( P < 0.00001). Intensive care unit length of stay ( P = 0.0001) and hospital length of stay ( P < 0.0001) were shorter with ministernotomy compared to full sternotomy. This review found that minimally invasive approaches to isolated aortic valve replacement result in reduced early mortality and select measures of postoperative morbidity; however, long-term mortality is not significantly different based on surgical approach. An analysis of mortality alone is not sufficient for the selection of the optimal approach to isolated aortic valve replacement. Surgeon experience, individual patient characteristics, and preference require thorough consideration, and additional studies investigating quality of life measures will be imperative in identifying the optimal approach to isolated aortic valve replacement.
Topics: Humans; Aortic Valve; Heart Valve Prosthesis Implantation; Quality of Life; Treatment Outcome; Retrospective Studies; Minimally Invasive Surgical Procedures
PubMed: 36728720
DOI: 10.1097/CRD.0000000000000488 -
International Journal of Cardiology Apr 2023Transcatheter edge-to-edge repair (TEER) of the mitral valve has emerged as the standard treatment for patients with mitral regurgitation (MR) with high surgical risk....
BACKGROUND
Transcatheter edge-to-edge repair (TEER) of the mitral valve has emerged as the standard treatment for patients with mitral regurgitation (MR) with high surgical risk. Even though MitraClip is widely used, the novel PASCAL device system offers distinct technical features. We aim to study the safety and efficacy of the PASCAL repair system in clinically significant MR.
METHODS
PubMed, Medline, Cochrane Central Register of Controlled Trials, and EMBASE were searched for articles published from August 2016 until June 2022 to identify studies that investigated the safety and efficacy of PASCAL for patients with degenerative, functional and mixed MR. Primary performance endpoints were technical, device, and procedural successes. Primary safety endpoint was composite 30 day major adverse events (MAE). Secondary endpoints were MR grade at discharge and 30 days, 30 day postprocedural NYHA functional class, left ventricular ejection fraction (LVEF), change in 6-min walk distance (6MWD), 30-day and 12-month all-cause mortality.
RESULTS
We included twelve retrospective and prospective observational studies and one randomized controlled study consisting of 1028 patients with severe, symptomatic MR (NYHA III-IV: 84.0%, MR ≥ 3+: 99.7%) and high surgical risk (mean logistic EuroSCORE of 16.4).Technical success was 95.7%, procedural success was 95.2%, and device success was 86.1% relative to the weighted average. MR grade was ≤2+ in 94.7% of patients at discharge and 94.0% patients at 30-day follow-up. Mean 30-day and 12-month mortality after device implantation were 4.54% and 12.2%.
CONCLUSION
The PASCAL repair system appears to be a safe and effective therapeutic option to treat severe, symptomatic MR in high surgical risk patients.
Topics: Humans; Mitral Valve Insufficiency; Stroke Volume; Heart Valve Prosthesis Implantation; Retrospective Studies; Ventricular Function, Left; Treatment Outcome; Cardiac Catheterization; Observational Studies as Topic
PubMed: 36681242
DOI: 10.1016/j.ijcard.2023.01.026