-
Journal of Clinical Medicine Sep 2023Transcatheter aortic valve replacement (TAVR) is currently the treatment of choice for patients aged ≥75 years with severe aortic stenosis. Preoperative anemia is... (Review)
Review
Transcatheter aortic valve replacement (TAVR) is currently the treatment of choice for patients aged ≥75 years with severe aortic stenosis. Preoperative anemia is present in a large proportion of patients and may increase the risk of post-procedural complications. The purpose of this prognostic systematic review was to analyze the impact of baseline anemia on short- and mid-term outcomes following TAVR. A computerized search was performed on PubMed and Web of Science databases for studies published between January 2013 and December 2022. Primary outcomes were 30-day need for transfusion, acute renal failure, 30-day and mid-term mortality, and readmission during the first year post-TAVR. Data were analyzed via random effects model using inverse variance method with 95% confidence intervals. Eleven observational studies met our eligibility criteria and included a total of 12,588 patients. The prevalence of baseline anemia ranged between 39% and 72%, with no relevant sex differences. Patients with preprocedural anemia received more blood transfusions [OR: 2.95 (2.13-4.09)]), and exhibited increased rates of acute kidney injury [OR:1.74 (1.45-2.10)], short-term mortality [OR: 1.47 (1.07-2.01], and mid-term [OR: 1.89 (1.58-2.25)] mortality following TAVR compared with those without anemia. Baseline anemia determined an increased risk for blood transfusion, acute kidney injury, and short/mid-term mortality among TAVR recipients.
PubMed: 37762965
DOI: 10.3390/jcm12186025 -
Clinical Medicine (London, England) Nov 2023Recent randomised trials have shown that clinical outcomes with transcatheter aortic valve implantation (TAVI) are non-inferior to surgical aortic valve replacement... (Meta-Analysis)
Meta-Analysis Review
Recent randomised trials have shown that clinical outcomes with transcatheter aortic valve implantation (TAVI) are non-inferior to surgical aortic valve replacement (SAVR) in patients with symptomatic aortic stenosis at intermediate to low risk. Health-related quality of life (HrQoL) outcomes in these patient groups remain uncertain. A systematic search of the literature was conducted that included nine trials and 11,295 patients. Kansas City Cardiomyopathy Questionnaire (KCCQ), a heart-failure-specific measure and EuroQol-5D (EQ-5D) (a generic health status tool) changes were the primary outcomes. New York Heart Association (NYHA) classification was the secondary outcome. Improvement in KCCQ scores was greater with TAVI (mean difference (MD)=13.56, 95% confidence interval (CI) 11.67-15.46, p<0.001) at 1 month, as was the improvement in EQ-5D (MD=0.07, 95% CI 0.05-0.08, p<0.001). There was no difference in KCCQ (MD=1.05, 95% CI -0.11 to 2.21, p=0.08) or EQ-5D (MD=-0.01, 95% CI -0.03 to 0.01), p=0.37) at 12 months. NYHA functional class 3/4 was lower in patients undergoing TAVI at 1 month (MD=0.51, 95% CI 0.34-0.78, p=0.002), but there was no difference at 12 months (MD=1.10; 95% CI 0.87-1.38, p=0.43). Overall, TAVI offers early benefit in HRQoL outcomes compared with SAVR, but they are equivalent at 12 months.
Topics: Humans; Transcatheter Aortic Valve Replacement; Quality of Life; Aortic Valve Stenosis; Aortic Valve; Risk; Treatment Outcome; Risk Factors
PubMed: 38065591
DOI: 10.7861/clinmed.2023-0258 -
Current Problems in Cardiology Nov 2023Transcatheter aortic valve replacement (TAVR) is indicated for high-risk patients with severe degenerative aortic stenosis (AS). Given the shared risk factors and... (Meta-Analysis)
Meta-Analysis Review
Transcatheter aortic valve replacement (TAVR) is indicated for high-risk patients with severe degenerative aortic stenosis (AS). Given the shared risk factors and coexistence of obstructive coronary artery disease (CAD) and AS, there is inconsistent clinical data regarding potential survival benefits of paired percutaneous coronary intervention (PCI) with TAVR procedures. We performed a literature search using PubMed, Embase, and Cochrane Library from inception through June 2023 assessing the impact of concomitant PCI in patients with obstructive CAD undergoing TAVR. The primary outcomes were 30-day all-cause mortality, 30-day cardiovascular mortality, and 6 months-1 year all-cause mortality. Secondary outcomes included 30-day myocardial infarction, stroke, major bleeding complications, and acute kidney injury (AKI). A total of 11 studies involving 2804 patients were included in the final analysis. Compared to patients undergoing TAVR alone, the TAVR+PCI group showed no significant difference in 30-day all-cause mortality (RR 0.90, CI 0.66, 1.22, P = 0.49), 30-day cardiovascular mortality (RR 0.71 CI 0.44, 1.14, P = 0.16), or 6 months-1 year all-cause mortality (RR 0.94, CI 0.75, 1.18, P = 0.57). Regarding secondary outcomes, 30-day myocardial infarction was higher in the TAVR+PCI group (RR 3.09, CI 1.26, 7.57, P = 0.01), with no significant differences noted in rates of 30-day stroke (RR 1.14, CI 0.56, 2.33, P = 0.72), major bleeding/vascular complications (RR 1.11, CI 0.79, 1.56, P = 0.55), and AKI (RR 1.07, CI 0.75, 1.54, P = 0.71). Concomitant PCI does not confer any mortality benefit in patients with obstructive CAD and high-grade AS undergoing TAVR. Further trials are needed to confirm our findings.
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve Stenosis; Percutaneous Coronary Intervention; Aortic Valve; Coronary Artery Disease; Risk Factors; Myocardial Infarction; Stroke; Treatment Outcome; Acute Kidney Injury; Hemorrhage
PubMed: 37473936
DOI: 10.1016/j.cpcardiol.2023.101980 -
Current Problems in Cardiology May 2024Transcatheter Aortic Valve Replacement (TAVR) is the treatment of choice in patients with severe aortic stenosis. Transcarotid (TCa) or Trans-axillary/subclavian... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Transcatheter Aortic Valve Replacement (TAVR) is the treatment of choice in patients with severe aortic stenosis. Transcarotid (TCa) or Trans-axillary/subclavian (TAx/Sc) are safer and less invasive non-femoral approaches, where transfemoral access is difficult or impossible to obtain.
METHODS
This meta-analysis was performed based on PRISMA guidelines after registering in PROSPERO (CRD42023482842). This meta-analysis was performed to compare the safety of the transcarotid and trans-axillary/subclavian approach for TAVR including studies from inception to October 2023.
RESULTS
Seven studies with a total of 6227 patients were included in the analysis (TCa: 2566; TAx/Sc: 3661). Transcarotid TAVR approach had a favorable trend for composite of stroke and all-cause mortality (OR 0.79, CI 0.60-1.04), all-cause mortality, stroke, major vascular complication, and new requirement of permanent pacemaker though those were statistically insignificant. On sub-analysis of the results of the studies based on the territory (USA vs French), composite outcome of all cause mortality, stroke and major bleeding (OR 0.54, CI 0.54-0.81), composite of stroke and all cause mortality (OR 0.64, CI 0.50-0.81), and stroke/TIA (OR 0.53, CI 0.39-0.73) showed lower odds of occurrence among patient managed with TCa approach in the American cohort.
CONCLUSION
Overall, transcarotid approach had favorable though statistically insignificant odds for composite (stroke and all-cause mortality) and individual outcomes (stroke, all-cause mortality, etc.). There are significant variations in observed outcomes based on study's geographic location. Large prospective randomized clinical trials comparing the two approaches with representative samples are necessary to guide the clinicians in choosing among these approaches.
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve; Aortic Valve Stenosis; Prospective Studies; Risk Factors; Treatment Outcome; Time Factors; Stroke
PubMed: 38417474
DOI: 10.1016/j.cpcardiol.2024.102488 -
Heart, Lung & Circulation Sep 2023Current pharmacological options for hypertrophic cardiomyopathy (HCM) are not disease-specific; while it treats symptoms, mavacamten targets the underlying pathology. We... (Review)
Review
BACKGROUND
Current pharmacological options for hypertrophic cardiomyopathy (HCM) are not disease-specific; while it treats symptoms, mavacamten targets the underlying pathology. We aim to assess the efficacy and safety of mavacamten, a first-in-class cardiac myosin inhibitor, in symptomatic obstructive HCM.
METHODS
This systematic review of the literature followed the PRISMA guidelines. Title/abstract and topics were searched using the following term: "mavacamten". The electronic research literature databases included the Cochrane Library, MedLine, and clinicaltrials.gov from July to August 2022. Primary efficacy endpoint was to assess clinical response at the end of treatment compared with baseline, defined as, at least one New York Heart Association (NYHA) class reduction. Two secondary endpoints from baseline were determined. The first was defined as improvement in mixed venous oxygen pressure (pVO). The second was defined as reduction of the post-exercise left ventricular outflow tract (LVOT) gradient.
RESULTS
We included in our analyses data from four studies that met our review eligibility criteria. There were three randomised placebo-controlled clinical trials and one non-randomised open-label clinical trial. All four studies showed a reduction in NYHA class from mavacamten use. Three out of four studies demonstrated >1 NYHA functional class improvement ranging from 34% to 80%, while only one study showed a smaller percentage of patients remaining at class 3. Three out of four studies measured pVO as an outcome, and all three studies noticed an increase in peak oxygen consumption after mavacamten treatment. Additionally, three out of four studies measured post-exercise LVOT gradient reduction as an outcome and all three found significant reduction in the post-exercise LVOT gradient after treatment. The most commonly observed adverse side effects were atrial fibrillation and decreased left ventricular ejection fraction, but all participants recovered without long-term sequelae and only one patient dropped out of the trial.
CONCLUSIONS
Mavacamten has a greater efficacy than placebo in the treatment of HCM. It also showed promising tolerability and efficacy profiles in the treatment of HCM in adults. The three endpoints used in the evaluation of studies were reduction in NYHA class, increase in pVO, and post-exercise LVOT gradient reduction. Mavacamten showed greater reduction in NYHA, larger effects on increase of pVO, and significant reduction of the LVOT gradient. Mavacamten was also found to be well tolerated, like the placebo. The side effect profile was limited for the majority of individuals taking mavacamten. In the future, authors recommended dose-optimisation studies, and studies that evaluate mavacamten both in comparison to, and in conjunction with other current treatments.
Topics: Adult; Humans; Cardiomyopathy, Hypertrophic; Heart; Stroke Volume; Ventricular Function, Left; Clinical Trials as Topic
PubMed: 37453852
DOI: 10.1016/j.hlc.2023.05.019 -
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 -
Arquivos Brasileiros de Cardiologia 2023The extent of cardiac damage associated with aortic stenosis has important prognostic implications after transcatheter aortic valve replacement (TAVR). However, the role... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The extent of cardiac damage associated with aortic stenosis has important prognostic implications after transcatheter aortic valve replacement (TAVR). However, the role of tricuspid regurgitation (TR) in this clinical setting is still unclear.
OBJECTIVES
To explore the association between TR and mortality in patients undergoing TAVR and assess changes in TR severity post TAVR and its relationship with short and mid-term mortality.
METHODS
Relevant databases were searched for articles published from inception until August 2020. Out of 414 screened studies, we selected 24 that reported the degree of TR pre or post TAVR. The primary outcome was all-cause mortality, and random effects meta-analysis models were conducted (at a significance level of 5%).
RESULTS
Seventeen studies reported associations between pre-TAVR TR and all-cause mortality (> 45,000 participants) and thirteen accessed TR severity post TAVR (709 participants). Moderate/severe baseline TR was associated to higher all-cause mortality both at 30 days (HR 1.65; 95% CI, 1.20-2.29) and 1.2 years (HR 1.56; 95% CI, 1.31-1.84). After TAVR, 43% of patients presented a decrease of at least one grade in TR (30 days, 95% CI, 30-56%), sustained at 12.5 months in 44% of participants (95% CI, 35-52%). Persistence of significant TR was associated with a two-fold increase in all-cause mortality (HR 2.12; 95% CI, 1.53-2.92).
CONCLUSIONS
Significant TR pre TAVR is associated with higher mortality. Although TR severity may improve, the persistence of significant TR post TAVR is strongly associated with increased mortality. Our findings highlight the importance of a detailed assessment of TR pre and post TAVR and might help identify patients who may benefit from more careful surveillance in this scenario.
Topics: Humans; Transcatheter Aortic Valve Replacement; Tricuspid Valve Insufficiency; Treatment Outcome; Risk Factors; Prognosis; Aortic Valve Stenosis; Aortic Valve; Severity of Illness Index
PubMed: 37556650
DOI: 10.36660/abc.20220319 -
Journal of Clinical Medicine Jun 2024The optimal timing to perform percutaneous coronary interventions (PCIs) in patients undergoing transcatheter aortic valve replacement (TAVR) is not well established.... (Review)
Review
The optimal timing to perform percutaneous coronary interventions (PCIs) in patients undergoing transcatheter aortic valve replacement (TAVR) is not well established. In this meta-analysis, we aimed to compare the outcomes of patients undergoing PCI before versus after TAVR. A comprehensive literature search was performed including Medline, Embase, and Cochrane electronic databases up to 5 April 2024 for studies that compared PCI before and after TAVR reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The analyzed outcomes were mortality, stroke, and myocardial infarction (MI) at follow-up. A total of 3 studies involving 1531 patients (pre-TAVR PCI = 1240; post-TAVR PCI = 291) were included in this meta-analysis following our inclusion criteria. Mortality was higher in the pre-TAVR PCI group (OR: 2.48; 95% CI: 1.19-5.20; = 0.02). No differences were found between PCI before and after TAVR for the risk of stroke (OR: 3.58; 95% CI: 0.70-18.15; = 0.12) and MI (OR: 0.66; 95% CI: 0.30-1.42; = 0.29). This meta-analysis showed in patients with stable CAD undergoing TAVR that PCI after TAVR is associated with lower mortality compared with PCI before TAVR.
PubMed: 38930050
DOI: 10.3390/jcm13123521 -
Journal of Cardiovascular Computed... 2023Different methodologies have been used to assess the role of AV calcification (AVC) on TAVI outcomes. This systematic review aims to describe the burden of AVC,... (Meta-Analysis)
Meta-Analysis Review
Different methodologies have been used to assess the role of AV calcification (AVC) on TAVI outcomes. This systematic review aims to describe the burden of AVC, synthesize the different methods of calcium score quantification, and evaluate the impact of AVC on outcomes after TAVI. We included studies of TAVI patients who had reported AV calcium scoring by contrast-enhanced multidetector CT and the Agatston method. The impact of calcification on TAVI outcomes without restrictions on follow-up time or outcome type was evaluated. Results were reported descriptively, and a meta-analysis was conducted when feasible. Sixty-eight articles were included, with sample sizes ranging from 23 to 1425 patients. Contrast-enhanced calcium scoring was reported in 30 studies, calcium volume score in 28 studies, and unique scoring methods in two. All studies with calcium volume scores had variable protocols, but most utilized a modified Agatston method with variable attenuation threshold values of 300-850 HU. Eight studies used the Agatston method, with the overall mean AV calcium score in studies published from 2010 to 2012 of 3342.9 AU [95%CI: 3150.4; 3535.4, I2 = 0%]. The overall mean score was lower and heterogenous in studies published from 2014 to 2020 (2658.9 AU [95% CI: 2517.3; 2800.5, I2 = 79%]. Most studies reported a positive association between calcium burden and increased risk of adverse outcomes, including implantation of permanent pacemaker (7/8 studies), paravalvular leak (13/13 studies), and risk of aortic rupture (2/2 studies). AVC quantification methodology with contrast-enhanced CT is still variable. AVC negatively impacts TAVI outcomes independently of the quantification method.
Topics: Humans; Aortic Valve; Calcium; Aortic Valve Stenosis; Predictive Value of Tests; Transcatheter Aortic Valve Replacement; Multidetector Computed Tomography; Calcinosis; Severity of Illness Index; Retrospective Studies; Treatment Outcome
PubMed: 37635033
DOI: 10.1016/j.jcct.2023.08.010 -
Open Heart Jan 2024A quarter of patients with severe aortic stenosis (AS) were asymptomatic, and only a third of them survived at the end of 4 years. Only a select subset of these patients... (Meta-Analysis)
Meta-Analysis
Systematic review and meta-analysis of early aortic valve replacement versus conservative therapy in patients with asymptomatic aortic valve stenosis with preserved left ventricle systolic function.
BACKGROUND
A quarter of patients with severe aortic stenosis (AS) were asymptomatic, and only a third of them survived at the end of 4 years. Only a select subset of these patients was recommended for aortic valve replacement (AVR) by the current American College of Cardiology/American Heart Association guidelines. We intended to study the effect of early AVR (eAVR) in this subset of asymptomatic patients with preserved left ventricle function.
METHODS AND RESULTS
We searched PubMed and Embase for randomised and observational studies comparing the effect of eAVR versus conservative therapy in patients with severe, asymptomatic AS and normal left ventricular function. The primary outcome was all-cause mortality. The secondary outcomes were composite major adverse cardiac events (MACE) (study defined), myocardial infarction (MI), stroke, cardiac death, sudden death, the development of symptoms, heart failure hospitalisations and major bleeding. We used GRADEPro to assess the certainty of the evidence. In the randomised controlled trial (RCT) only analysis, we found no significant difference in all-cause mortality between the early aortic intervention group versus the conservative arm (CA) (incidence rate ratio, IRR (CI): 0.5 (0.2 to 1.1), I=31%, p=0.09). However, in the overall cohort, we found mortality benefit for eAVR over CA (IRR (CI): 0.4 (0.3 to 0.7), I=84%, p<0.01). There were significantly lower MACE, cardiac death, sudden death, development of symptoms and heart failure hospitalisations in the eAVR group. We noticed no difference in MI, stroke and major bleeding.
CONCLUSION
We conclude that there is no reduction in all-cause mortality in the eAVR arm in patients with asymptomatic AS with preserved ejection fraction. However, eAVR reduces heart failure related hospitalisations and death or heart failure hospitalisations.
PROSPERO REGISTRATION NUMBER
CRD42022306132.
Topics: Humans; Aortic Valve; Aortic Valve Stenosis; Conservative Treatment; Death, Sudden, Cardiac; Heart Failure; Hemorrhage; Myocardial Infarction; Stroke; United States; Ventricular Function, Left; Heart Valve Prosthesis Implantation; Transcatheter Aortic Valve Replacement
PubMed: 38191233
DOI: 10.1136/openhrt-2023-002511