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Circulation Oct 2023Type 2 diabetes (T2D) is associated with an increased risk of left ventricular dysfunction after aortic valve replacement (AVR) in patients with severe aortic stenosis...
Association Between Type 2 Diabetes and Changes in Myocardial Structure, Contractile Function, Energetics, and Blood Flow Before and After Aortic Valve Replacement in Patients With Severe Aortic Stenosis.
BACKGROUND
Type 2 diabetes (T2D) is associated with an increased risk of left ventricular dysfunction after aortic valve replacement (AVR) in patients with severe aortic stenosis (AS). Persistent impairments in myocardial energetics and myocardial blood flow (MBF) may underpin this observation. Using phosphorus magnetic resonance spectroscopy and cardiovascular magnetic resonance, this study tested the hypothesis that patients with severe AS and T2D (AS-T2D) would have impaired myocardial energetics as reflected by the phosphocreatine to ATP ratio (PCr/ATP) and vasodilator stress MBF compared with patients with AS without T2D (AS-noT2D), and that these differences would persist after AVR.
METHODS
Ninety-five patients with severe AS without coronary artery disease awaiting AVR (30 AS-T2D and 65 AS-noT2D) were recruited (mean, 71 years of age [95% CI, 69, 73]; 34 [37%] women). Thirty demographically matched healthy volunteers (HVs) and 30 patients with T2D without AS (T2D controls) were controls. One month before and 6 months after AVR, cardiac PCr/ATP, adenosine stress MBF, global longitudinal strain, NT-proBNP (N-terminal pro-B-type natriuretic peptide), and 6-minute walk distance were assessed in patients with AS. T2D controls underwent identical assessments at baseline and 6-month follow-up. HVs were assessed once and did not undergo 6-minute walk testing.
RESULTS
Compared with HVs, patients with AS (AS-T2D and AS-noT2D combined) showed impairment in PCr/ATP (mean [95% CI]; HVs, 2.15 [1.89, 2.34]; AS, 1.66 [1.56, 1.75]; <0.0001) and vasodilator stress MBF (HVs, 2.11 mL min g [1.89, 2.34]; AS, 1.54 mL min g [1.41, 1.66]; <0.0001) before AVR. Before AVR, within the AS group, patients with AS-T2D had worse PCr/ATP (AS-noT2D, 1.74 [1.62, 1.86]; AS-T2D, 1.44 [1.32, 1.56]; =0.002) and vasodilator stress MBF (AS-noT2D, 1.67 mL min g [1.5, 1.84]; AS-T2D, 1.25 mL min g [1.22, 1.38]; =0.001) compared with patients with AS-noT2D. Before AVR, patients with AS-T2D also had worse PCr/ATP (AS-T2D, 1.44 [1.30, 1.60]; T2D controls, 1.66 [1.56, 1.75]; =0.04) and vasodilator stress MBF (AS-T2D, 1.25 mL min g [1.10, 1.41]; T2D controls, 1.54 mL min g [1.41, 1.66]; =0.001) compared with T2D controls at baseline. After AVR, PCr/ATP normalized in patients with AS-noT2D, whereas patients with AS-T2D showed no improvements (AS-noT2D, 2.11 [1.79, 2.43]; AS-T2D, 1.30 [1.07, 1.53]; =0.0006). Vasodilator stress MBF improved in both AS groups after AVR, but this remained lower in patients with AS-T2D (AS-noT2D, 1.80 mL min g [1.59, 2.0]; AS-T2D, 1.48 mL min g [1.29, 1.66]; =0.03). There were no longer differences in PCr/ATP (AS-T2D, 1.44 [1.30, 1.60]; T2D controls, 1.51 [1.34, 1.53]; =0.12) or vasodilator stress MBF (AS-T2D, 1.48 mL min g [1.29, 1.66]; T2D controls, 1.60 mL min g [1.34, 1.86]; =0.82) between patients with AS-T2D after AVR and T2D controls at follow-up. Whereas global longitudinal strain, 6-minute walk distance, and NT-proBNP all improved after AVR in patients with AS-noT2D, no improvement in these assessments was observed in patients with AS-T2D.
CONCLUSIONS
Among patients with severe AS, those with T2D demonstrate persistent abnormalities in myocardial PCr/ATP, vasodilator stress MBF, and cardiac contractile function after AVR; AVR effectively normalizes myocardial PCr/ATP, vasodilator stress MBF, and cardiac contractile function in patients without T2D.
Topics: Humans; Female; Male; Aortic Valve; Diabetes Mellitus, Type 2; Ventricular Function, Left; Aortic Valve Stenosis; Vasodilator Agents; Adenosine Triphosphate; Heart Valve Prosthesis Implantation
PubMed: 37746744
DOI: 10.1161/CIRCULATIONAHA.122.063444 -
Computers in Biology and Medicine Mar 2024Aortic valve disease is often treated with bioprosthetic valves. An alternative treatment is aortic valve neocuspidization which is a relatively new reparative procedure...
Aortic valve disease is often treated with bioprosthetic valves. An alternative treatment is aortic valve neocuspidization which is a relatively new reparative procedure whereby the three aortic cusps are replaced with patient pericardium or bovine tissues. Recent research indicates that aortic blood flow is disturbed, and turbulence effects have yet to be evaluated in either bioprosthetic or aortic valve neocuspidization valve types in patient-specific settings. The aim of this study is to better understand turbulence production in the aorta and evaluate its effects on laminar and turbulent wall shear stress. Four patients with aortic valve disease were treated with either bioprosthetic valves (n=2) or aortic valve neocuspidization valvular repair (n=2). Aortic geometries were segmented from magnetic resonance images (MRI), and 4D flow MRI was used to derive physiological inlet and outlet boundary conditions. Pulsatile large-eddy simulations were performed to capture the full range of laminar, transitional and turbulence characteristics in the aorta. Turbulence was produced in all aortas with highest levels occurring during systolic deceleration. In the ascending aorta, turbulence production is attributed to a combination of valvular skew, valvular eccentricity, and ascending aortic dilation. In the proximal descending thoracic aorta, turbulence production is dependent on the type of arch-descending aorta connection (e.g., a narrowing or sharp bend) which induces flow separation. Laminar and turbulent wall shear stresses are of similar magnitude throughout late systolic deceleration and diastole, although turbulent wall shear stress magnitudes exceed laminar wall shear stresses between 27.3% and 61.1% of the cardiac cycle. This emphasises the significance of including turbulent wall shear stress to improve our comprehension of progressive arterial wall diseases. The findings of this study recommend that aortic valve treatments should prioritise minimising valvular eccentricity and skew in order to mitigate turbulence generation.
Topics: Humans; Animals; Cattle; Aortic Valve; Blood Flow Velocity; Hemodynamics; Aorta; Aortic Valve Disease; Stress, Mechanical
PubMed: 38354498
DOI: 10.1016/j.compbiomed.2024.108123 -
BMC Cardiovascular Disorders Jul 2023Bicuspid aortic valve (BAV) patients have an increased risk to develop thoracic aortic complications. Little is known about the prevalence and severity of...
INTRODUCTION
Bicuspid aortic valve (BAV) patients have an increased risk to develop thoracic aortic complications. Little is known about the prevalence and severity of atherosclerosis in the BAV ascending aortic wall. This study evaluates and compares the prevalence of thoracic aortic atherosclerosis in BAV and tricuspid aortic valve (TAV) patients.
METHODS
Atherosclerosis was objectified using three diagnostic modalities in two separate BAV patient cohorts (with and without an aortic dilatation). Within the first group, atherosclerosis was graded histopathologically according to the modified AHA classification scheme proposed by Virmani et al. In the second group, the calcific load of the ascending aorta and coronary arteries, coronary angiographies and cardiovascular risk factors were studied. Patients were selected from a surgical database (treated between 2006-2020), resulting in a total of 128 inclusions.
RESULTS
Histopathology showed atherosclerotic lesions to be more prevalent and severe in all TAV as compared to all BAV patients (OR 1.49 (95%CI 1.14 - 1.94); p = 0.003). Computed tomography showed no significant differences in ascending aortic wall calcification between all BAV and all TAV patients, although a tendency of lower calcific load in favor of BAV was seen. Coronary calcification was higher in all TAV as compared to all BAV (OR 1.30 (95%CI 1.06 - 1.61); p = 0.014).
CONCLUSION
Ascending aortic atherosclerotic plaques were histologically more pronounced in TAV as compared to the BAV patients, while CT scans revealed equal amounts of calcific depositions within the ascending aortic wall. This study confirms less atherosclerosis in the ascending aortic wall and coronary arteries of BAV patients as compared to TAV patients. These results were not affected by the presence of a thoracic aortic aneurysm.
Topics: Humans; Bicuspid Aortic Valve Disease; Heart Valve Diseases; Case-Control Studies; Aortic Valve; Aortic Diseases; Atherosclerosis
PubMed: 37468858
DOI: 10.1186/s12872-023-03396-4 -
Procedural safety of transcatheter aortic valve replacement with Portico valve: a systematic review.International Journal of Surgery... Nov 2023The Portico transcatheter aortic heart valve is a self-expandable, fully resheathable bioprosthetic valve with a nitinol frame and porcine pericardial sealing cuff. It...
BACKGROUND
The Portico transcatheter aortic heart valve is a self-expandable, fully resheathable bioprosthetic valve with a nitinol frame and porcine pericardial sealing cuff. It has been used among symptomatic severe aortic stenosis (AS) who are at high or extreme surgical risk. However, till date very few studies has been reported with inconclusive evidence for its postprocedure safety outcomes.
OBJECTIVE
The authors aim to evaluate the safety of the Portico transcatheter aortic valve replacement system among patients with AS.
METHODOLOGY
The authors conducted a systematic literature search on PubMed, Embase, and Scopus from inception till 10th April 2023 by using predefined MESH terms using 'AND' and 'OR'. The following search terms were used: 'Aortic Stenosis' AND 'Transcatheter aortic valve replacement' OR 'Portico valve'. Finally, descriptive statistics were used to summarize the data in this paper. The mean and SD were adopted to describe continuous variables, whereas frequencies and percentages were used for dichotomous data.
RESULTS
A total of 7 studies with 2782 patients were included in the analysis. The mean age of patients was 82.3 years, and 54.63% were female. The most common comorbidity was hypertension (65.21%) and diabetes mellitus (26.45%). Among patients of AS with Portico valve implants, postprocedural outcomes including 30-day mortality (2.32%), cardiovascular mortality (2.37%), stroke (2.23%), myocardial infarction (0.94%), major bleeding (3.97%), major vascular complications (4.91%), acute kidney injury (1.37%), and permanent pacemaker implantations in 15.73% patients were reported. Overall, device success was observed in 95.82% of patients.
CONCLUSION
Transcatheter aortic valve replacement with the repositionable Portico valve, a new bioprosthesis, appears to have a low postprocedural mortality rate and other clinical outcomes in high-risk patients with severe AS.
Topics: Humans; Female; Animals; Swine; Aged, 80 and over; Male; Transcatheter Aortic Valve Replacement; Aortic Valve; Treatment Outcome; Postoperative Complications; Aortic Valve Stenosis; Heart Valve Prosthesis; Prosthesis Design
PubMed: 37581642
DOI: 10.1097/JS9.0000000000000645 -
Journal of Cardiothoracic Surgery Jun 2024We aimed to summarise the existing knowledge regarding antithrombotic medications following surgical aortic valve replacement (SAVR) using a biological valve prosthesis. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
We aimed to summarise the existing knowledge regarding antithrombotic medications following surgical aortic valve replacement (SAVR) using a biological valve prosthesis.
METHODS
We performed a meta-analysis of studies that reported the results of using antithrombotic medication to prevent thromboembolic events after SAVR using a biological aortic valve prosthesis and recorded the outcomes 12 months after surgery. Since no randomised controlled trials were identified, observational studies were included. The analyses were conducted separately for periods of 0-12 months and 3-12 months after surgery. A random effects model was used to calculate pooled outcome event rates and 95% confidence intervals (CIs).
RESULTS
The search yielded eight eligible observational studies covering 6727 patients overall. The lowest 0- to 12-month mortality was observed in patients with anticoagulation (2.0%, 95% CI 0.4-9.7%) and anticoagulation combined with antiplatelet therapy (2.2%, 95% CI 0.9-5.5%), and the highest was in patients without antithrombotic medication (7.3%, 95% CI 3.6-14.2%). Three months after surgery, mortality was lower in anticoagulant patients (0.5%, 95% CI 0.1-2.6%) than in antiplatelet patients (3.0%, 95% CI 1.2-7.4%) and those without antithrombotics (3.5%, 95% CI 1.3-9.3%). There was no eligible evidence of differences in stroke rates observed among medication strategies. At 0- to 12-month follow-up, all antithrombotic treatment regimens resulted in an increased bleeding rate (antiplatelet 4.2%, 95% CI 2.9-6.1%; anticoagulation 7.5%, 95% CI 3.8-14.4%; anticoagulation combined with antiplatelet therapy 8.3%, 95% CI 5.7-11.8%) compared to no antithrombotic medication (1.1%, 95% CI 0.4-3.4%). At 3- to 12-month follow-up, there was up to an eight-fold increase in the bleeding rate in patients with anticoagulation combined with antiplatelet therapy when compared to those with no antithrombotic medication. Overall, the evidence certainty was ranked as very low.
CONCLUSION
Although this meta-analysis reveals that anticoagulation therapy has a beneficial tendency in terms of mortality at 1 year after biological SAVR and suggests potential advantages in continuing anticoagulation beyond 3 months, it is limited by very low evidence certainty. The imperative for cautious interpretation and the urgent need for more robust randomised research underscore the complexity of determining optimal antithrombotic strategies in this patient population.
Topics: Humans; Fibrinolytic Agents; Heart Valve Prosthesis; Aortic Valve; Heart Valve Prosthesis Implantation; Thromboembolism; Bioprosthesis; Postoperative Complications; Anticoagulants; Platelet Aggregation Inhibitors
PubMed: 38926789
DOI: 10.1186/s13019-024-02863-z -
Journal of Cardiothoracic Surgery Nov 2023Aortic annulus rupture remains one of the most fatal complications of TAVR. While attempts have been made to describe and predict this complication, the data remains...
OBJECTIVE
Aortic annulus rupture remains one of the most fatal complications of TAVR. While attempts have been made to describe and predict this complication, the data remains insufficient without evidence-based guidelines for management of this rare complication.
METHODS
Here we describe a series of 3 aortic annulus ruptures after TAVR which were managed successfully to hospital discharge.
RESULTS
Patient 1 suffered annulus rupture during balloon valvuloplasty prior to TAVR. The patient became hypotensive, and echocardiogram showed pericardial effusion. The patient underwent pericardiocentesis which transiently improved the blood pressure, but bleeding continued. The patient was transitioned to an open surgical aortic valve replacement due to ongoing hemorrhage. The chest was left open with delayed closure on post-op day 2. The patient was discharged on post-op day 15. Patient 2 was undergoing TAVR valve expansion. The patient became hypotensive. An echocardiogram revealed pericardial effusion. Pericardiocentesis yielded 200 mL of blood. SURGIFLO (Johnson & Johnson Wound Management, Somerville, NJ) was injected into the pericardial space. Aortic root angiography confirmed no further contrast extravasation. A pericardial drain was left in place for 2 days, and the patient was discharged on post-op day 7. Patient 3 received a TAVR valve and post-placement dilation due to paravalvular leak. The echocardiogram showed a pericardial effusion. Pericardiocentesis was performed, yielding 500 cc of blood. The patient's healthcare proxy declined emergent surgery; thus, a pericardial drain was placed. No hemostatic agents were used, and drainage reduced over several hours. The drain was removed on post-op day 3, and the patient was discharged on post-op day 8.
CONCLUSIONS
Based on the timelines in these three cases, and interventions used, the following steps may be employed in the event of annulus rupture: identification of hemodynamic instability, echocardiogram to confirm pericardial effusion, emergent pericardiocentesis, pericardial drain placement for evacuation of the pericardial space and use of hemostatic agents, repeat aortogram to rule out ongoing extravasation. If hemostasis is unable to be achieved and/or the patient becomes hemodynamically unstable at any point, rapid transition to emergent surgical management is necessary. This management strategy proved successful for this case series and warrants further investigation.
Topics: Humans; Transcatheter Aortic Valve Replacement; Aortic Valve Stenosis; Pericardial Effusion; Aortic Valve; Heart Valve Prosthesis; Aortic Rupture; Treatment Outcome; Prosthesis Design
PubMed: 37957662
DOI: 10.1186/s13019-023-02426-8 -
Circulation. Cardiovascular... May 2024Acute aortic regurgitation is life-threatening with few nonsurgical options for immediate stabilization. We propose Trans-Aortic Balloon to Ease Regurgitation Applying...
BACKGROUND
Acute aortic regurgitation is life-threatening with few nonsurgical options for immediate stabilization. We propose Trans-Aortic Balloon to Ease Regurgitation Applying Counter-Pulsation (TABERNACL), a simple, on-table temporary valve using commercially available equipment to temporize acute severe aortic regurgitation.
METHODS
We hypothesize that an appropriately sized commercial balloon dilatation catheter-straddling the aortic annulus and connected to a counterpulsation console-can serve as a temporizing valve to restore hemodynamic stability in acute aortic regurgitation. We performed benchtop testing of valvuloplasty, angioplasty, and sizing balloons as counterpulsation balloons. TABERNACL was assessed in vivo in a porcine model of acute aortic regurgitation (n=8). We also tested a static undersized, continuously inflated transvalvular balloon as a spacer intended physically to obstruct the regurgitant orifice.
RESULTS
Benchtop testing identified that Tyshak II and PTS sizing (NuMed Braun) balloon catheters performed adequately as temporary valves (ie, complete inflation and deflation with each cycle) and resisted fatigue, in contrast to others. When TABERNACL was used in the acute severe regurgitation animals, there was immediate hemodynamic improvement, with a significant 35% increase in diastolic aortic pressure by 16 mm Hg ([95% CI, 7-25] =0.0056), 34% reduction in left ventricular end-diastolic pressure by -7 mm Hg ([95% CI, -10 to -5] =0.0006), improvement in the aortic diastolic index by 0.28 ([95% CI, 0.18-0.39] =0.0009), and reversal of electrocardiographic myocardial ischemia. As an alternative, static balloon inflation across the aortic valve stabilized regurgitation hemodynamics at the expense of a new aortic gradient and caused excessive ectopy from balloon movement in the left ventricular outflow tract.
CONCLUSIONS
TABERNACL improves hemodynamics and reduces coronary ischemia by electrocardiography in animals with acute severe aortic regurgitation. TABERNACL valves obstruct the diastolic regurgitant orifice without systolic obstruction. This may prove a lifesaving bridge to definitive valve replacement therapy.
Topics: Animals; Hemodynamics; Aortic Valve Insufficiency; Disease Models, Animal; Balloon Valvuloplasty; Sus scrofa; Aortic Valve; Equipment Design; Recovery of Function; Acute Disease; Cardiac Catheters; Time Factors; Severity of Illness Index; Ventricular Function, Left
PubMed: 38533653
DOI: 10.1161/CIRCINTERVENTIONS.123.013898 -
Journal of Cardiovascular Translational... Aug 2023Aortic stenosis is a condition which is fatal if left untreated. Novel quantitative imaging techniques which better characterise transvalvular pressure drops are being...
Aortic stenosis is a condition which is fatal if left untreated. Novel quantitative imaging techniques which better characterise transvalvular pressure drops are being developed but require refinement and validation. A customisable and cost-effective workbench valve phantom circuit capable of replicating valve mechanics and pathology was created. The reproducibility and relationship of differing haemodynamic metrics were assessed from ground truth pressure data alongside imaging compatibility. The phantom met the requirements to capture ground truth pressure data alongside ultrasound and magnetic resonance image compatibility. The reproducibility was successfully tested. The robustness of three different pressure drop metrics was assessed: whilst the peak and net pressure drops provide a robust assessment of the stenotic burden in our phantom, the peak-to-peak pressure drop is a metric that is confounded by non-valvular factors such as wave reflection. The peak-to-peak pressure drop is a metric that should be reconsidered in clinical practice. The left panel shows manufacture of low cost, functional valves. The central section demonstrates circuit layout, representative MRI and US images alongside gross valve morphologies. The right panel shows the different pressure drop metrics that were assessed for reproducibility.
Topics: Humans; Aortic Valve; Reproducibility of Results; Benchmarking; Aortic Valve Stenosis; Hemodynamics
PubMed: 36745287
DOI: 10.1007/s12265-022-10350-w -
Journal of Cardiothoracic Surgery Nov 2023Biomechanical effects of transcatheter (TAVR) versus surgical (SAVR) aortic valve interventions on the distal aorta have not been studied. This study utilized global...
BACKGROUND
Biomechanical effects of transcatheter (TAVR) versus surgical (SAVR) aortic valve interventions on the distal aorta have not been studied. This study utilized global circumferential strain (GCS) to assess post-procedural biomechanics changes in the descending aorta after TAVR versus SAVR.
METHODS
Patients undergoing TAVR or SAVR for aortic stenosis were included. Transesophageal (TEE) and transthoracic (TTE) echocardiography short-axis images of the aorta were used to image the descending aorta immediately before and after interventions. Image analysis was performed with two-dimensional speckle tracking echocardiography and dedicated software. Delta GCS was calculated as: post-procedural GCS-pre-procedural GCS. Percentage delta GCS was calculated as: (delta GCS/pre-procedural GCS) × 100.
RESULTS
Eighty patients, 40 TAVR (median age 81 y/o, 40% female) and 40 SAVR (median 72 y/o, 30% female) were included. The post-procedure GCS was significantly higher than the pre-procedural GCS in the TAVR (median 10.7 [interquartile range IQR 4.5, 14.6] vs. 17.0 [IQR 6.1, 20.9], p = 0.009) but not in the SAVR group (4.4 [IQR 3.3, 5.3] vs. 4.7 [IQR 3.9, 5.6], p = 0.3). The delta GCS and the percentage delta GCS were both significantly higher in the TAVR versus SAVR group (2.8% [IQR 1.4, 6] vs. 0.15% [IQR - 0.6, 1.5], p < 0.001; and 28.8% [IQR 14.6%, 64.6%] vs. 4.4% [IQR - 10.6%, 5.6%], p = 0.006). Results were consistent after multivariable adjustment for key clinical and hemodynamic characteristics.
CONCLUSIONS
After TAVR, there was a significantly larger increase in GCS in the distal aorta compared to SAVR. This may impact descending aortic remodeling and long-term risk of aortic events.
Topics: Humans; Female; Aged, 80 and over; Male; Aortic Valve; Heart Valve Prosthesis Implantation; Transcatheter Aortic Valve Replacement; Biomechanical Phenomena; Treatment Outcome; Aortic Valve Stenosis; Risk Factors
PubMed: 38037164
DOI: 10.1186/s13019-023-02467-z -
Innovations (Philadelphia, Pa.) 2024The surgical treatment of aortic stenosis continues to evolve, and sutureless aortic valve replacement (SUAVR) is an emerging technology. With the Perceval S (Corcym,... (Review)
Review
OBJECTIVE
The surgical treatment of aortic stenosis continues to evolve, and sutureless aortic valve replacement (SUAVR) is an emerging technology. With the Perceval S (Corcym, London, UK) as the only true sutureless valve on the market, the objective of this review is to analyze the current literature on Perceval S. Focusing on valve design and deployment as well as applications of the technology for challenging pathology, clinical outcomes are assessed, including a comparison with transcatheter AVR (TAVR).
METHODS
PubMed and MEDLINE were searched by 3 authors for studies analyzing SUAVR from inception to May 19, 2023.
RESULTS
SUAVR facilitates minimally invasive surgery and offers an alternative strategy for patients with small aortic annuli. It also has a time-saving advantage for patients who require complex operations. SUAVR results in excellent long-term morbidity, mortality, durability, and hemodynamic function. In comparison with conventional surgical AVR (SAVR), SUAVR does have a greater risk of postoperative pacemaker implantation; however, increasing user experience and refinements in implantation technique have contributed to reductions in this outcome. SUAVR results in morbidity and mortality that is similar to rapid-deployment AVR. Midterm outcomes are superior to TAVR; however, further robust investigation into all of these comparisons is ultimately necessary.
CONCLUSIONS
SUAVR bridges the gap in technology between SAVR and TAVR. The application of this exciting technology will undoubtedly grow in the coming years, during which additional investigation is paramount to optimize preoperative planning, valve deployment, and reintervention strategies.
Topics: Humans; Bioprosthesis; Heart Valve Prosthesis; Aortic Valve Stenosis; Aortic Valve; Sutureless Surgical Procedures; Transcatheter Aortic Valve Replacement; Heart Valve Prosthesis Implantation; Prosthesis Design; Minimally Invasive Surgical Procedures; Treatment Outcome
PubMed: 38465600
DOI: 10.1177/15569845241231989