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.
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.
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.