This week’s cardiovascular brief covers randomized device readouts, a pivotal drug setback, first-in-human guidance tech, procedural innovations, and adoption milestones—plus more industry news. .
In Today’s Newsletter
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❤️ TB HEART study highlights cardiac risk in pulmonary TB [1] [Zambia • 12 Nov 2025]
Key point: Higher-than-expected heart-disease burden in PTB; blood tests may stratify risk (endpoints not specified).
Context: Single-site observational study, Kanyama General Hospital, n=252 (Nov 2023–Oct 2024); findings shared 23 Oct 2025.
Implication: Could inform practice and payer discussions; depends on study design and confounding control.
🧘 HRV-biofeedback for post-concussion symptoms in veterans, HERO trial [2] [14 Nov 2025]
https://www.concussionalliance.org/blog/hero-study-investigates-hrv-biofeedback-therapy-for-veterans
Key point: Testing HRV-biofeedback to reduce headaches, fatigue, sleep, dizziness, and cognitive symptoms.
Context: Six weekly sessions plus daily home practice vs control; vagal activation; endpoints not specified.
Implication: Could inform practice and payer discussions; depends on study design and confounding control.
🫀 Venus P valve offers minimally invasive option in repaired TOF adults at NHCS [3] [Singapore • 14 Nov 2025]
https://www.eurekalert.org/news-releases/1106047
Key point: Six Venus P implants enabled pulmonary valve replacement without open-heart surgery.
Context: Adult repaired TOF with severe pulmonary regurgitation; rapid recovery; AI-enabled 4D-flow research cited.
Implication: May influence prescriber choice and payer reviews pending full data.
💉 Myval vs Sapien/Evolut, 1-year LANDMARK RCT readout at PCR London Valves [4] [UK • 17 Nov 2025]
Key point: Myval showed comparable 1-year composite efficacy to Sapien and Evolut; low moderate AR.
Context: Head-to-head RCT in severe AS; QoL sustained; small-annulus post-hoc comparable.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Librexia ACS milvexian trial stopped for futility on primary endpoint [5] [18 Nov 2025]
Key point: IDMC said primary efficacy unlikely to be met; no new safety issues.
Context: Add-on to antiplatelets in recent ACS; AF and SSP Phase 3 continue toward 2026 toplines.
Implication: May influence prescriber choice and payer reviews pending full data.
❄️ ICECAP to test coronary cryotherapy with DeepOCT+NIRS imaging [6] [18 Nov 2025]
Key point: ICECAP will evaluate catheter-based cryotherapy to stabilise high-risk plaques.
Context: Up to five sites in Belgium/UK; start Q1 2026; HyperVue multimodality imaging with AI.
Implication: Signals pipeline investment and modality expansion.
🤖 First clinical TAVI cases guided by AI intra-op software (TAVIPILOT Soft) [7] [France • 18 Nov 2025]
https://cardiovascularnews.com/first-clinical-procedures-performed-using-ai-tavi-guidance-software/
Key point: First-in-human AI guidance during Sapien 3 TAVI with accurate predicted-vs-final depth.
Context: SAITO-1A, 10 patients, transfemoral; no intra-procedural complications; early commercialization targeted end-2025.
Implication: Signals pipeline investment and modality expansion.
🔧 JenaValve Trilogy marks 1,000 commercial TAVI implants for AR [8] [Germany • 18 Nov 2025]
https://cardiovascularnews.com/trilogy-tavi-valve-reaches-1000-commercial-cases/
Key point: 1,000th Trilogy implant underscores adoption for severe AR in Europe.
Context: Case milestone in Cologne; reproducibility and outcomes cited in historically undertreated AR.
Implication: Introduces competition that may affect pricing and formulary access.
Why it matters
- Comparative TAVI data may refine platform choice in severe AS and small annulus patients.
- AR-specific TAVI options are scaling, potentially shifting care away from open surgery.
- Post-ACS anticoagulation landscape may pivot if FXIa efficacy varies by indication.
- Non-stent approaches to vulnerable plaque are moving into prospective imaging-guided evaluation.
- AI guidance in structural heart procedures could standardise deployment and training.
- Cardio-infectious and neuro-autonomic intersections highlight multimodal care needs.
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FAQ
What did the Zambart TB HEART study specifically show?
Higher heart-disease burden among pulmonary TB patients with possible blood-test risk stratification in a single-site study; specific endpoints/biomarkers not specified [1].
How is HRV-biofeedback being tested in the HERO trial?
Six weekly sessions plus twice-daily breathing practice vs non-biofeedback control for persistent post-concussion symptoms in veterans/service members; endpoints not specified [2].
Who can benefit from the Venus P valve at NHCS?
Adults with repaired TOF and severe pulmonary regurgitation; six implants reported with fast recovery; institutional experience, not randomized [3].
Did Myval outperform Sapien or Evolut at 1 year in LANDMARK?
Composite clinical efficacy was comparable across platforms with low moderate AR for Myval; full dataset not provided in summary [4].
Why was Librexia ACS halted, and do other milvexian trials continue?
IDMC judged the ACS study unlikely to meet the primary endpoint; AF and STROKE programs continue toward 2026 toplines [5].
What is unique about the ICECAP study design?
Cryotherapy paired with DeepOCT+NIRS imaging and AI analysis to track plaque features such as cap thickness and lipid burden [6].
Entities / Keywords
Zambart; TB HEART; pulmonary TB; cardiovascular risk; HRV-biofeedback; HERO; veterans; Venus P; National Heart Centre Singapore; TOF; 4D-flow CMR; INITIATE; PROPAGATE; Meril; Myval; LANDMARK; Edwards Sapien; Medtronic Evolut; BMS; Johnson & Johnson; milvexian; Librexia; FXIa inhibitor; CryoTherapeutics; SpectraWAVE; HyperVue; CRF; ICECAP; Caranx Medical; TAVIPILOT Soft; TAVI; JenaValve; Trilogy; aortic regurgitation.
References
- https://www.zambart.org.zm/2025/11/12/heart-disease-a-major-concern-for-tb-patients-reveals-zambart-study/
- https://www.concussionalliance.org/blog/hero-study-investigates-hrv-biofeedback-therapy-for-veterans
- https://www.eurekalert.org/news-releases/1106047
- https://cardiovascularnews.com/pcr-london-valves-2025-hears-latest-data-from-landmark-trial-of-myval-tavi-device/
- https://cardiovascularnews.com/librexia-acs-trial-of-factor-xia-inhibitor-in-acs-patients-ended-early/
- https://cardiovascularnews.com/cryotherapeutics-spectrawave-and-crf-partner-for-icecap-clinical-study/
- https://cardiovascularnews.com/first-clinical-procedures-performed-using-ai-tavi-guidance-software/
- https://cardiovascularnews.com/trilogy-tavi-valve-reaches-1000-commercial-cases/