Daily Cardiology Research Analysis
A head-to-head randomized trial (COMPARE-TAVI 1) found Myval transcatheter heart valves non-inferior to SAPIEN 3 at 1 year, informing device selection in TAVI programs. An engineering advance introduced a motion-unrestricted, imperceptible 12-lead dynamic ECG system enabling artifact-minimized monitoring during movement. A prospective cohort showed abdominal aortic aneurysm volume tracking outperforms maximum diameter for surveillance, potentially reducing imaging visits while improving risk str
Summary
A head-to-head randomized trial (COMPARE-TAVI 1) found Myval transcatheter heart valves non-inferior to SAPIEN 3 at 1 year, informing device selection in TAVI programs. An engineering advance introduced a motion-unrestricted, imperceptible 12-lead dynamic ECG system enabling artifact-minimized monitoring during movement. A prospective cohort showed abdominal aortic aneurysm volume tracking outperforms maximum diameter for surveillance, potentially reducing imaging visits while improving risk stratification.
Research Themes
- Comparative effectiveness of TAVI devices
- Wearable imperceptible electronics for dynamic ECG monitoring
- Imaging biomarker optimization for AAA surveillance
Selected Articles
1. SAPIEN 3 versus Myval transcatheter heart valves for transcatheter aortic valve implantation (COMPARE-TAVI 1): a multicentre, randomised, non-inferiority trial.
In this all-comers Danish RCT (n=1031), the 1-year composite of death, stroke, moderate/severe aortic regurgitation, or moderate/severe hemodynamic THV deterioration was 13% with SAPIEN 3 vs 14% with Myval, meeting the prespecified non-inferiority margin. Findings support Myval as a clinically comparable alternative to SAPIEN 3 for transfemoral TAVI.
Impact: A large, randomized head-to-head comparison directly informs device choice and procurement decisions in TAVI programs and may broaden access to effective THV options.
Clinical Implications: Centers can consider Myval as a non-inferior alternative to SAPIEN 3 for transfemoral TAVI. Adoption may be guided by patient-specific anatomy, operator experience, availability, and cost without compromising 1-year composite outcomes.
Key Findings
- Primary composite endpoint at 1 year: 13% (SAPIEN 3) vs 14% (Myval); risk difference −0.9% (one-sided upper 95% CI 4.4%), meeting non-inferiority.
- All-comers, multicenter randomized design with 1031 patients (median age 81.6 years; 40% women).
- Third VARC criteria used; intention-to-treat and per-protocol analyses planned.
Methodological Strengths
- Multicenter, randomized, all-comers non-inferiority design with prespecified margin and VARC-3 endpoints.
- Balanced device sizing and standardized transfemoral approach; intention-to-treat framework.
Limitations
- The abstract does not report individual component outcomes or longer-term durability beyond 1 year.
- Enrollment pauses due to legal proceedings could introduce operational variability; generalizability outside Denmark requires caution.
Future Directions: Report device-specific secondary outcomes (e.g., pacemaker implantation, gradients, leaflet thrombosis) and extend follow-up for durability and structural valve deterioration. Cost-effectiveness analyses across health systems would inform procurement.
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a guideline-directed treatment for severe aortic stenosis and degenerated aortic bioprostheses. When new transcatheter heart valve (THV) platforms for TAVI are launched, they should be compared with best-in-practice contemporary THVs for their short-term and long-term performance. The COMPARE-TAVI 1 trial was designed to provide a head-to-head comparison of the SAPIEN 3 or SAPIEN 3 Ultra THVs and the Myval or Myval Octacor THVs. METHODS: This multicentre, all-comers, randomised, non-inferiority trial was done at three university hospitals in Denmark. Eligible patients were aged 18 years or older, scheduled for transfemoral TAVI, and eligible for treatment with SAPIEN 3 THVs or Myval THVs. Patients were randomly assigned (1:1) to treatment with SAPIEN 3 (29 mm diameter) or SAPIEN 3 Ultra (20 mm, 23 mm, or 26 mm diameter) THVs or Myval or Myval Octacor THVs (20-32 mm diameter). The TAVI procedure was performed according to local practice and under local anaesthesia unless leaflet laceration was performed. The primary endpoint was a composite of death, stroke, moderate or severe aortic regurgitation, or moderate or severe haemodynamic THV deterioration at 1 year according to Third Valve Academic Research Consortium criteria. All patients assigned to THV treatment were included in the intention-to-treat analysis, and all patients who were treated as randomly assigned were included in the per-protocol analysis. With an expected event rate of 13%, the prespecified non-inferiority margin was 5·3%. This trial is registered with ClinicalTrials.gov, NCT04443023, and is closed to accrual. FINDINGS: Between June 15, 2020, and Nov 3, 2023, 1031 patients were enrolled. Enrolment was paused twice because of patent-related legal proceedings. Of 1031 patients, 517 patients were randomly assigned to SAPIEN 3 THVs and 514 to Myval THVs. The median patient age was 81·6 years (IQR 77·6-85·0), and 415 (40%) of 1031 patients were female and 616 (60%) were male. The primary endpoint occurred in 67 (13%) of 517 patients randomly assigned to SAPIEN 3 THVs versus 71 (14%) of 514 patients randomly assigned to Myval THVs (risk difference -0·9% [one-sided upper 95% CI 4·4%]; p INTERPRETATION: Myval THVs were non-inferior to SAPIEN 3 THVs in terms of a 1-year composite endpoint of death, stroke, moderate or severe aortic regurgitation, or moderate or severe haemodynamic THV deterioration. FUNDING: Meril Life Sciences, Vingmed Denmark, the Danish Heart Foundation, and the Central Denmark Region.
2. Motion-unrestricted dynamic electrocardiogram system utilizing imperceptible electronics.
The MU-DCG platform integrates skin-conformal, ultra-thin electrodes and a pressure-activated skin socket to deliver comfortable, motion-robust 12-lead ECG monitoring. Blinded cardiologists verified minimal motion artifacts, demonstrating anti-motion interference acquisition and in-situ analysis during dynamic movement.
Impact: This device-level innovation directly addresses a longstanding barrier in ambulatory ECG—motion artifacts—potentially enabling high-fidelity long-term monitoring for arrhythmia and ischemia screening.
Clinical Implications: If validated clinically at scale, MU-DCG could expand accurate ambulatory 12-lead monitoring for arrhythmia detection, ischemia assessment, and sudden cardiac arrest risk evaluation, reducing false alarms and repeat testing.
Key Findings
- Developed a motion-unrestricted dynamic 12-lead ECG system using skin-conformal, imperceptible electronics and ultra-thin on-skin electrodes.
- Introduced a pressure-activated flexible skin socket that stably connects soft on-skin and off-skin modules during dynamic movement.
- Blinded cardiologist evaluations confirmed minimal motion artifacts in MU-DCG signals, enabling anti-motion interference acquisition and in-situ analysis.
Methodological Strengths
- Blinded expert (cardiologist) evaluations of ECG signal quality to mitigate assessment bias.
- Engineering advances (skin-conformal, ultra-thin electrodes; pressure-activated skin socket) directly tested under dynamic conditions.
Limitations
- Clinical validation (sample size, patient diversity, diagnostic accuracy vs. standard Holter/patch) is not reported.
- Long-term durability, skin safety, regulatory pathway, and integration with clinical workflows require further study.
Future Directions: Prospective clinical studies comparing MU-DCG to gold-standard ambulatory ECG across arrhythmia subtypes, ischemia detection, and sudden death risk; integration with AI analytics and assessment of patient adherence and skin tolerance.
Electrocardiogram (ECG) plays a vital role in the prevention, diagnosis, and prognosis of cardiovascular diseases (CVDs). However, the lack of a user-friendly and accurate long-term dynamic electrocardiogram (DCG) device in motion has made it challenging to perform many daily cardiovascular risk screenings and assessments, such as sudden cardiac arrest, resulting in additional economic burdens on society. Here, we present a motion-unrestricted dynamic electrocardiogram (MU-DCG) system, which employs skin-conformal, imperceptible electronics for long-term, comfortable, and accurate 12-lead DCG monitoring. To facilitate assembly for use on the skin, the MU-DCG system features a pressure-activated flexible skin socket for stably soft-connecting the on-skin soft module and the off-skin stiff module during dynamic movements. Crucially, blinded cardiologist evaluations confirm minimal motion artifacts in MU-DCG-acquired ECG signals. Our results demonstrate that the MU-DCG system, with large-area, ultra-thin on-skin electrodes/leads, and an off-skin module, accomplishes anti-motion interference acquisition and in-situ analysis while retaining wearing imperceptibility.
3. The value of volume over maximum diameter for following abdominal aortic aneurysm growth and reducing surveillance visits in patients with a subthreshold aneurysm.
In a multicenter prospective cohort (n=126), AAA volume tracking detected growth outside measurement variability more often than maximum diameter and enabled safe reduction of 1-year surveillance imaging from 26% to 44% when combined with diameter. Positive predictive value for qualifying for surgery at 2 years improved from 57.7% to 72.5% with volume plus diameter.
Impact: Shifting surveillance metrics from diameter to volume can reduce unnecessary imaging while improving risk stratification, potentially changing guidelines for small AAA follow-up.
Clinical Implications: Incorporating volumetric assessment into AAA surveillance could safely extend follow-up intervals for many subthreshold aneurysms and better identify those likely to require surgery, though radiation exposure and resource needs must be balanced.
Key Findings
- Volume detected clinically meaningful change beyond interobserver variability more often than diameter (34% vs 65% within variability; P < .001).
- Combining diameter with volume allowed 44% of patients to safely skip 1-year surveillance imaging vs 26% with diameter alone (P = .002).
- Positive predictive value for 2-year surgery qualification improved from 57.7% (diameter alone) to 72.5% (diameter + volume; P < .001).
Methodological Strengths
- Prospective multicenter cohort with repeated standardized CT and centerline-based 3D reconstructions.
- Mixed-effects regression and time-to-event modeling with predictive value analyses tied to surgery/rupture/death endpoints.
Limitations
- CT-based volumetry introduces radiation exposure and may limit scalability; external validation across scanners and centers is needed.
- Moderate sample size; real-world implementation requires workflow and reimbursement considerations.
Future Directions: Validate volumetric thresholds and growth rates in larger, diverse cohorts; explore low-dose CT or MRI alternatives; assess cost-effectiveness and patient-centered outcomes from reduced surveillance.
OBJECTIVE: To describe and compare abdominal aortic aneurysm (AAA) volume to maximum diameter regarding follow-up of AAA progression and investigate its added value in AAA surveillance. METHODS: This prospective, observational cohort study included 126 patients enrolled in the multicenter BIOMArCS-AAA study (Study of Biomarker Profiling to Unravel the Intertwined Pathophysiology of Coronary Artery Disease and Abdominal Aortic Aneurysm) who were under surveillance for an AAA. Participants underwent computed tomography scans at study inclusion and after 1 and 2 years, alongside computed tomography scans for clinical care. Maximum diameter and total volume were measured after center lumen line reconstruction. Mixed-effects regression was used to evaluate the maximum diameter and volume changes over time. The value of volume alongside the maximum diameter to distinguish patients who will or will not experience the composite end point (qualifying for surgery, or AAA rupture/AAA-related death) was evaluated using Cox models and cumulative incidence-based positive and negative predictive values. RESULTS: A median of three scans were available per patient. The baseline median (25th, 75th percentile) maximum diameter and volume were 48 mm (45, 52 mm) and 109 mL (90, 130 mL), respectively. The observed median (25th, 75th percentile) growth at the 1-year follow-up was 2.3 mm (1.3, 3.1 mm) in maximum diameter, and 10.8 mL (7.0, 16.4 mL) in volume. Changes in aneurysm size at the next recommended surveillance visit lay within the boundaries of the interobserver variability for 81 patients (65%) when measuring maximum diameter, compared with 43 patients (34%) when measuring volume (P < .001). Using a single maximum diameter measurement, 32 patients (26%) could be exempt from surveillance imaging at 1 year, while ensuring that the risk of qualifying for surgery remains below 10%. When combining this with a simultaneous volume measurement, 54 patients (44%) could similarly be safely exempt from surveillance imaging (P = .002). Moreover, simultaneously measuring volume refines the identification of patients that will qualify for surgery at 2 years (positive predictive value diameter alone vs diameter and volume, 57.7% and 72.5%, respectively; P < .001). CONCLUSIONS: AAA volume is more sensitive to detect small changes in aneurysm size at the currently recommended surveillance intervals, and could be used to safely prolong surveillance intervals for patients with a small AAA. The use of volume should be encouraged in research and could prove valuable in AAA surveillance.