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Journal of Cardiothoracic Surgery Jun 2024Observational studies have shown reduced perioperative bleeding in patients undergoing minimally invasive, compared with full sternotomy, aortic valve replacement. Data... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
BACKGROUND
Observational studies have shown reduced perioperative bleeding in patients undergoing minimally invasive, compared with full sternotomy, aortic valve replacement. Data from randomized trials are conflicting.
METHODS
This was a Swedish single center study where adult patients with aortic stenosis, 100 patients were randomly assigned in a 1:1 ratio to undergo either minimally invasive (ministernotomy) or full sternotomy aortic valve replacement. The primary outcome was severe or massive bleeding defined by the Universal Definition of Perioperative Bleeding in adult cardiac surgery (UDPB). Secondary outcomes included blood product transfusions, chest tube output, re-exploration for bleeding, and several other clinically relevant events.
RESULTS
Out of 100 patients, three patients randomized to ministernotomy were intraoperatively converted to full sternotomy (none was bleeding-related). Three patients (6%) in the full sternotomy group and 3 patients (6%) in the ministernotomy group suffered severe or massive postoperative bleeding according to the UDPB definition (p = 1.00). Mean chest tube output during the first 12 postoperative hours was 350 (standard deviation (SD) 220) ml in the full sternotomy group and 270 (SD 190) ml in the ministernotomy group (p = 0.08). 28% of patients in the full sternotomy group and 36% of patients in the ministernotomy group received at least one packed red blood cells transfusion (p = 0.39). Two patients in each group (4%) underwent re-exploration for bleeding.
CONCLUSIONS
Minimally invasive aortic valve replacement did not result in less bleeding-related outcomes compared to full sternotomy.
CLINICAL TRIAL REGISTRATION
http://www.
CLINICALTRIALS
gov . Unique identifier: NCT02272621.
Topics: Humans; Male; Female; Minimally Invasive Surgical Procedures; Heart Valve Prosthesis Implantation; Aged; Sternotomy; Aortic Valve Stenosis; Aortic Valve; Postoperative Hemorrhage; Aged, 80 and over; Sweden; Middle Aged; Treatment Outcome; Blood Loss, Surgical
PubMed: 38907320
DOI: 10.1186/s13019-024-02667-1 -
BMC Anesthesiology Jun 2024We used transcatheter aortic valve implantation (TAVI) procedure time to investigate the association between surgical team maturity and outcome.
BACKGROUND
We used transcatheter aortic valve implantation (TAVI) procedure time to investigate the association between surgical team maturity and outcome.
METHODS
Among patients who underwent TAVI between October 2015 and November 2019, those who had Sapien™ implanted with the transfemoral artery approach were included in the analysis. We used TAVI procedure time and surgery number to draw a learning curve. Then, we divided the patients into two groups before and after the number of cases where the sigmoid curve reaches a plateau. We compared the two groups regarding the surveyed factors and investigated the correlation between the TAVI procedure time and survey factors.
RESULTS
Ninety-nine of 149 patients were analysed. The sigmoid curve had an inflection point in 23.2 cases and reached a plateau in 43.0 cases. Patients in the Late group had a shorter operating time, less contrast media, less radiation exposure, and less myocardial escape enzymes than the Early group. Surgical procedure time showed the strongest correlation with the surgical case number.
CONCLUSION
The number of cases required for surgeon proficiency for isolated Sapien™ valve implantation was 43. This number may serve as a guideline for switching the anesthesia management of TAVI from general to local anesthesia.
Topics: Humans; Transcatheter Aortic Valve Replacement; Retrospective Studies; Male; Female; Aged, 80 and over; Operative Time; Aged; Learning Curve; Clinical Competence; Treatment Outcome; Aortic Valve Stenosis
PubMed: 38907200
DOI: 10.1186/s12871-024-02594-7 -
Academic Radiology Jun 2024Cardiovascular CT is required for planning transcatheter aortic valve implantation (TAVI).
BACKGROUND
Cardiovascular CT is required for planning transcatheter aortic valve implantation (TAVI).
PURPOSE
To compare image quality, suitability for TAVI planning, and radiation dose of photon-counting CT (PCCT) with that of dual-source CT (DSCT).
MATERIAL AND METHODS
Retrospective study on consecutive TAVI candidates with aortic valve stenosis who underwent contrast-enhanced aorto-ilio-femoral PCCT and/or DSCT between 01/2022 and 07/2023. Signal-to-noise (SNR) and contrast-to-noise ratio (CNR) were calculated by standardized ROI analysis. Image quality and suitability for TAVI planning were assessed by four independent expert readers (two cardiac radiologists, two cardiologists) on a 5-point-scale. CT dose index (CTDI) and dose-length-product (DLP) were used to calculate effective radiation dose (eRD).
RESULTS
300 patients (136 female, median age: 81 years, IQR: 76-84) underwent 302 CT examinations, with PCCT in 202, DSCT in 100; two patients underwent both. Although SNR and CNR were significantly lower in PCCT vs. DSCT images (33.0 ± 10.5 vs. 47.3 ± 16.4 and 47.3 ± 14.8 vs. 59.3 ± 21.9, P < .001, respectively), visual image quality was higher in PCCT vs. DSCT (4.8 vs. 3.3, P < .001), with moderate overall interreader agreement among radiologists and among cardiologists (κ = 0.60, respectively). Image quality was rated as "excellent" in 160/202 (79.2%) of PCCT vs. 5/100 (5%) of DSCT cases. Readers found images suitable to depict the aortic valve hinge points and to map the femoral access path in 99% of PCCT vs. 85% of DSCT (P < 0.01), with suitability ranked significantly higher in PCCT vs. DSCT (4.8 vs. 3.3, P < .001). Mean CTDI and DLP, and thus eRD, were significantly lower for PCCT vs. DSCT (22.4 vs. 62.9; 519.4 vs. 895.5, and 8.8 ± 4.5 mSv vs. 15.3 ± 5.8 mSv; all P < .001).
CONCLUSION
PCCT improves image quality, effectively avoids non-diagnostic CT imaging for TAVI planning, and is associated with a lower radiation dose compared to state-of-the-art DSCT. Radiologists and cardiologists found PCCT images more suitable for TAVI planning.
PubMed: 38906782
DOI: 10.1016/j.acra.2024.06.014 -
JACC. Cardiovascular Interventions Jun 2024The optimal timing of noncardiac surgery (NCS) following transcatheter aortic valve replacement (TAVR) for aortic stenosis has not been elucidated by current national...
BACKGROUND
The optimal timing of noncardiac surgery (NCS) following transcatheter aortic valve replacement (TAVR) for aortic stenosis has not been elucidated by current national guidelines.
OBJECTIVES
The aim of this study was to evaluate the effect of the time interval between TAVR and NCS (Δt) on the perioperative risk of major adverse events (MAEs).
METHODS
All adult admissions for isolated TAVR for aortic stenosis were identified in the 2016 to 2020 Nationwide Readmissions Database. Patients who received NCS on subsequent admission were included for analysis and grouped by Δt as follows: ≤30, 31 to 60, 61 to 90, and >90 days. Multivariable regression models were constructed to examine the association of Δt with ensuing outcomes.
RESULTS
Of 3,098 patients (median age = 79 years, 41.6% female), 19.1% underwent NCS at ≤30 days, 22.9% at 31 to 60 days, 16.7% at 61 to 90 days, and 41.3% at >90 days. After adjustment, the odds of MAEs were similar for operations performed at ≤30 days (adjusted OR [AOR]: 1.05; 95% confidence interval [CI]: 0.74-1.50), 31 to 60 days (AOR: 0.97; 95% CI: 0.71-1.31), and 61 to 90 days (AOR: 0.95; 95% CI: 0.67-1.34), with those at >90 days as reference. When examining the average marginal effect of the interval to surgery, risk-adjusted MAE rates were statistically similar across Δt groups for elective status and NCS risk category combinations.
CONCLUSIONS
NCS within 30, 31 to 60, or 61 to 90 days after TAVR was not associated with increased odds of MAEs compared with operations after 90 days irrespective of NCS risk category or elective status. Our findings suggest that the interval between NCS and TAVR may not be an accurate predictor of MAE risk in this population.
PubMed: 38904608
DOI: 10.1016/j.jcin.2024.04.049 -
Journal of the American Heart... Jun 2024Cardiac amyloidosis (CA) is frequently found in older patients with aortic stenosis (AS). However, the prevalence of AS among patients with CA is unknown. The objective...
BACKGROUND
Cardiac amyloidosis (CA) is frequently found in older patients with aortic stenosis (AS). However, the prevalence of AS among patients with CA is unknown. The objective was to study the prevalence and prognostic impact of AS among patients with CA.
METHODS AND RESULTS
We conducted a retrospective analysis of a prospective registry comprising 976 patients with native aortic valves who were confirmed with wild type transthyretin amyloid (ATTRwt), hereditary variant transthyretin amyloid (ATTRv), or immunoglobulin light-chain (AL) CA. CA patients' echocardiograms were re-analyzed focusing on the aortic valve. Multivariable Cox regression analysis was performed to assess the mortality risk associated with moderate or greater AS in ATTRwt CA. The crude prevalence of AS among patients with CA was 26% in ATTRwt, 8% in ATTRv, and 5% in AL. Compared with population-based controls, all types of CA had higher age- and sex-standardized rate ratios (SRRs) of having any degree of AS (AL: SRR, 2.62; 95% Confidence Interval (CI) [1.09-3.64]; ATTRv: SRR, 3.41; 95%CI [1.64-4.60]; ATTRwt: SRR, 10.8; 95%CI [5.25-14.53]). Compared with hospital controls, only ATTRwt had a higher SRR of having any degree of AS (AL: SRR, 0.97, 95%CI [0.56-1.14]; ATTRv: SRR, 1.27; 95%CI [0.85-1.44]; ATTRwt: SRR, 4.01; 95%CI [2.71-4.54]). Among patients with ATTRwt, moderate or greater AS was not associated with increased all-cause death after multivariable adjustment (hazard ratio, 0.71; 95%CI [0.42-1.19]; =0.19).
CONCLUSIONS
Among patients with CA, ATTRwt but not ATTRv or AL is associated with a higher prevalence of patients with AS compared with hospital controls without CA, even after adjusting for age and sex. In our population, having moderate or greater AS was not associated with a worse outcome in patients with ATTRwt.
PubMed: 38904242
DOI: 10.1161/JAHA.124.034723 -
Frontiers in Physiology 2024Transcatheter aortic valve replacement (TAVR) is a minimally invasive interventional solution for treating aortic stenosis. The complex post-TAVR complications are...
Transcatheter aortic valve replacement (TAVR) is a minimally invasive interventional solution for treating aortic stenosis. The complex post-TAVR complications are associated with the type of valve implanted and the position of the implantation. The study aimed to establish a rapid numerical research method for TAVR to assess the performance differences of self-expanding valves released at various positions. It also aimed to calculate the risks of postoperative paravalvular leak and atrioventricular conduction block, comparing these risks to clinical outcomes to verify the method's effectiveness and accuracy. Based on medical images, six cases were established, including the aortic wall, native valve and calcification; one with a bicuspid aortic valve and five with tricuspid aortic valves. The parameters for the stent materials used by the patients were customized. High strain in the contact area between the stent and the valve annulus may lead to atrioventricular conduction block. Postoperatively, the self-expanding valve maintained a circular cross-section, reducing the risk of paravalvular leak and demonstrating favorable hemodynamic characteristics, consistent with clinical observations. The outcomes of the six simulations showed no significant difference in valve frame morphology or paravalvular leak risk compared to clinical results, thereby validating the numerical simulation process proposed for quickly selecting valve models and optimal release positions, aiding in TAVR preoperative planning based on patients'geometric characteristics.
PubMed: 38903911
DOI: 10.3389/fphys.2024.1407215 -
Cureus May 2024The decision to assess the severity and determine the ideal timing of intervention for low-gradient aortic stenosis poses a greater challenge. Recently, a novel method...
PURPOSE
The decision to assess the severity and determine the ideal timing of intervention for low-gradient aortic stenosis poses a greater challenge. Recently, a novel method for determining the flow status of patients with aortic stenosis has been introduced, utilizing flow rate measurements. In this study, we investigated whether the flow status of patients with low-gradient aortic stenosis is linked to mortality within a three-year timeframe.
METHODS
Twenty-nine patients diagnosed with low-gradient aortic stenosis and valve area ≤ 1 cm were identified during 2010-2015. Each patient's flow rate across the aortic valve was computed, and the study scrutinized echocardiographic parameters to ascertain their correlation with mortality over a three-year timeframe.
RESULTS
We observed that among patients with low-gradient aortic stenosis and a valve area of ≤1 cm, a decreased flow rate across the aortic valve emerged as an independent predictor of mortality. A flow rate < 210 ml/s was linked with a three-year mortality rate of 66.7%, whereas a low stroke volume index < 35 ml/m² did not show an association with three-year mortality. This observation might be attributed to the smaller body sizes prevalent among these older patients, particularly females, which could influence the calculation of the stroke volume index.
CONCLUSION
In older patients with low-gradient aortic stenosis, the flow rate can better reflect flow status than the stroke volume index, and it also suggests a prognostic significance in predicting mortality. Additional studies are warranted to validate these findings across broader patient populations and to assess the potential efficacy of early intervention strategies in this particular patient cohort.
PubMed: 38903309
DOI: 10.7759/cureus.60776 -
Journal of Cardiothoracic Surgery Jun 2024The aim of this study is to report the preliminary real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing aortic valve replacement...
BACKGROUND
The aim of this study is to report the preliminary real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing aortic valve replacement with Perceval PLUS sutureless valve.
METHODS
MANTRA is an ongoing "umbrella" prospective, multi-center, international post-market study to collect real-life safety and performance data on Corcym devices (Corcym S.r.l, Saluggia, Italy). Clinical and echocardiographic outcomes were collected preoperatively, at discharge and at each follow up. KCCQ-12 and EQ-5D-5L quality of life questionnaires were collected preoperatively and at 30-days.
RESULTS
A total of 328 patients underwent aortic valve replacement with Perceval PLUS in 29 International institutions. Patients were enrolled from July 2021 to October 2023 and enrollment is still ongoing. Mean age was 71.9 ± 6.4 years, mean EuroSCORE II was 2.9 ± 3.9. Minimally invasive approach was performed in 44.2% (145/328) of patients; concomitant procedures were done in 40.8% (134/328) of cases. Thirty-day mortality was 1.8% (6/328) and no re-interventions were reported. Pacemaker implant was required in 4.0% (13/328) of the patients. The assessment of the functional status demonstrated marked and stable improvement in NYHA class in most patients at 30-day follow-up, with significant increase of KCCQ-12 summary score (from 58.8 ± 23.0 to 71.8 ± 22.1, p < 0.0001) and EQ-5D-5L VAS score (from 64.5 ± 20.4 to 72.6 ± 17.5, p < 0.0001). Mean pressure gradient decreased from 46.2 ± 17.3 mmHg to 10.1 ± 4.7 mmHg at 30-day follow-up. Low or no incidence of moderate-to-severe paravalvular or central leak was reported.
CONCLUSIONS
Preliminary results demonstrate good clinical outcomes and significant improvement of Quality of Life at 30-days, excellent early hemodynamic performance within patient implanted with Perceval PLUS.
TRIAL REGISTRATION
The MANTRA study has been registered in ClinicalTrials.gov (NCT05002543, Initial release 26 July 2021).
Topics: Humans; Aged; Male; Female; Prospective Studies; Heart Valve Prosthesis; Aortic Valve; Heart Valve Prosthesis Implantation; Treatment Outcome; Aortic Valve Stenosis; Prosthesis Design; Sutureless Surgical Procedures; Quality of Life; Hemodynamics; Aged, 80 and over; Middle Aged
PubMed: 38902742
DOI: 10.1186/s13019-024-02861-1 -
BMC Cardiovascular Disorders Jun 2024Previous studies have shown the importance of energy deficiency and malfunctioning mitochondria in the pathophysiology of hypertrophic cardiomyopathy (HCM). There has... (Observational Study)
Observational Study
BACKGROUND
Previous studies have shown the importance of energy deficiency and malfunctioning mitochondria in the pathophysiology of hypertrophic cardiomyopathy (HCM). There has been a little research into the relationship between plasma free fatty acids (FFA), one of the heart's main energy sources, and HCM. We evaluated its clinical importance in HCM to see if there was a link between plasma FFA metabolism and HCM.
METHODS
In a single-center retrospective observational study, we investigated 420 HCM patients diagnosed at Beijing Anzhen Hospital between January 1, 2018, and December 31, 2022. Meanwhile, 1372 individuals without HCM (non-HCM) were recruited. 391 non-HCM patients were chosen as controls via a propensity score matching (PSM) study with a 1:1 ratio.
RESULTS
FFA in HCM patients showed statistically significant correlations with creatinine (r = 0.115, p = 0.023), estimated GFR (r=-0.130, p = 0.010), BNP (r = 0.152, p = 0.007), LVEF (r=-0.227, p < 0.001), LVFS (r=-0.160, p = 0.002), and LAD (r = 0.112, p = 0.028). Higher FFA levels were found in HCM patients who had atrial fibrillation and NYHY functional classes III or IV (p = 0.015 and p = 0.022, respectively). In HCM patients, multiple linear regression analysis revealed that BNP and LVEF had independent relationships with increasing FFA (Standardized = 0.139, p = 0.013 and =-0.196, p < 0.001, respectively).
CONCLUSIONS
Among HCM patients, the plasma FFA concentration was lower, and those with AF and NYHY functional class III or IV had higher FFA levels, and LVEF and BNP were independently associated with increasing FFA. The findings of the study should help inspire future efforts to better understand how energy deficiency contributes to hypertrophic cardiomyopathy (HCM) development.
Topics: Humans; Cardiomyopathy, Hypertrophic; Retrospective Studies; Male; Female; Fatty Acids, Nonesterified; Middle Aged; Biomarkers; Adult; Energy Metabolism; Aged; Ventricular Function, Left; Beijing
PubMed: 38902636
DOI: 10.1186/s12872-024-03925-9 -
Insights Into Imaging Jun 2024Transfemoral aortic valve implantation (TAVI) has been long considered the standard of therapy for high-risk patients with severe aortic-stenosis and is now effectively... (Review)
Review
Transfemoral aortic valve implantation (TAVI) has been long considered the standard of therapy for high-risk patients with severe aortic-stenosis and is now effectively employed in place of surgical aortic valve replacement also in intermediate-risk patients. The potential lasting consequences of minor complications, which might have limited impact on elderly patients, could be more noteworthy in the longer term when occurring in younger individuals. That's why a greater focus on early diagnosis, correct management, and prevention of post-procedural complications is key to achieve satisfactory results. ECG-triggered multidetector computed tomography angiography (CTA) is the mainstay imaging modality for pre-procedural planning of TAVI and is also used for post-interventional early detection of both acute and long-term complications. CTA allows detailed morphological analysis of the valve and its movement throughout the entire cardiac cycle. Moreover, stent position, coronary artery branches, and integrity of the aortic root can be precisely evaluated. Imaging reliability implies the correct technical setting of the computed tomography scan, knowledge of valve type, normal post-interventional findings, and awareness of classic and life-threatening complications after a TAVI procedure. This educational review discusses the main post-procedural complications of TAVI with a specific imaging focus, trying to clearly describe the technical aspects of CTA Imaging in post-TAVI and its clinical applications and challenges, with a final focus on future perspectives and emerging technologies. CRITICAL RELEVANCE STATEMENT: This review undertakes an analysis of the role computed tomography angiography (CTA) plays in the assessment of post-TAVI complications. Highlighting the educational issues related to the topic, empowers radiologists to refine their clinical approach, contributing to enhanced patient care. KEY POINTS: Prompt recognition of TAVI complications, ranging from value issues to death, is crucial. Adherence to recommended scanning protocols, and the optimization of tailored protocols, is essential. CTA is central in the diagnosis of TAVI complications and functions as a gatekeeper to treatment.
PubMed: 38900378
DOI: 10.1186/s13244-024-01729-1