This week’s cardiovascular update brings together new clinical signals, imaging and AI advances, procedural innovation, and regulatory momentum shaping cardiovascular and neurovascular care.
In Today’s Newsletter
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🧠 ICAS perfusion markers predict early recurrence [1] [26 Nov 2025]
Context: Multicenter retrospective cohort across 35 sites, 2019–2024; symptomatic ICAS; 90-day recurrence focus.
Key point: Borderzone infarcts and hypoperfusion mismatch volume associated with higher early ischemic stroke recurrence despite aggressive medical therapy.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🫀 Dragonfly TEER data at PCR London Valves [2] [UK • 28 Nov 2025]
Context: Dragonfly-DMR China pivotal 3-year and Dragonfly EU pivotal 6-month interim; CE mark and NMPA approval noted.
Key point: Sustained MR reduction and NYHA improvement reported, with low SLDA; EU high-volume sites showed shorter procedure and device times.
Implication: May influence prescriber choice and payer reviews pending full data.
🖼️ Siemens launches Optiq AI interventional imaging chain [3] [US • 01 Dec 2025]
https://cardiovascularnews.com/siemens-launches-ai-powered-imaging-system-optiq-ai/
Context: Announced at RSNA; available on Artis genio, icono.explore, and icono.vision/pheno.vision platforms.
Key point: Real-time AI denoising and auto-exposure control aim to deliver high-quality, low-dose images across IR, cardiology, and MIS.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
📊 RSNA: Abdominal obesity and adverse cardiac remodelling [4] [US • 01 Dec 2025]
Context: CMR of 2,244 adults in the Hamburg City Health Study without known CVD.
Key point: Higher waist-to-hip ratio associated with concentric hypertrophy and smaller chamber volumes, more pronounced in men, independent of risk factors.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
📐 PREVENT equations percentile tools for 30-year CVD risk [5] [US • 01 Dec 2025]
https://www.acc.org/Latest-in-Cardiology/Journal-Scans/2025/12/01/21/57/New-Research-Adds
Context: JACC studies on age- and sex-specific percentiles using NHANES, external performance in 7.7M Korean adults, and CAC add-on analysis.
Key point: Percentiles may enhance communication in younger adults; PREVENT showed good discrimination and calibration in Korea; CAC may refine individual risk when uncertainty persists.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧩 Syngo.CT Coronary Cockpit for CAD planning [6] [US • 02 Dec 2025]
https://cardiovascularnews.com/new-imaging-tool-launched-to-aid-coronary-interventions/
Context: New Syngo.via module for dual-source and photon-counting CT.
Key point: Automated AI-based plaque segmentation and morphology to support therapy optimisation and potential CT-guided PCI planning.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
💊 Asundexian topline in secondary stroke prevention [7] [02 Dec 2025]
https://www.thecardiologyadvisor.com/news/asundexian-shows-promise-in-secondary-stroke-prevention/
Context: OCEANIC-STROKE randomized 12,327 adults post noncardioembolic stroke or high-risk TIA.
Key point: Asundexian 50 mg reduced ischemic stroke vs placebo on background antiplatelets with no observed increase in ISTH major bleeding (topline).
Implication: May influence prescriber choice and payer reviews pending full data.
🩺 Baxdrostat FDA Priority Review for hard-to-control HTN [8] [US • 02 Dec 2025]
Context: NDA accepted using a Priority Review voucher; based on BaxHTN Phase 3 presented at ESC 2025 and published in NEJM.
Key point: Baxdrostat met primary and secondary endpoints with meaningful SBP reductions and tolerability consistent with mechanism.
Implication: Introduces competition that may affect pricing and formulary access.
🧼 Brain lymphatic “clean-up” strategy for stroke, Monash–Yale [9] [AU • 02 Dec 2026]
Context: ARPA-H supported collaboration on non-invasive devices to enhance neck lymphatic pumping post stroke; early sex-difference imaging observations.
Key point: Targeting brain-draining lymphatics aims to improve waste clearance after ischemic stroke and enable sex-tailored strategies.
Implication: Signals pipeline investment and modality expansion.
👶 AI-assisted prenatal ultrasounds for CHD detection, Mount Sinai [10] [US • 02 Dec 2025]
Context: FDA-cleared BrightHeart software implemented at Carnegie Imaging; 200 second-trimester exams across 11 centers.
Key point: AI assistance associated with higher detection of scans suspicious for severe CHD, plus improved reader time and confidence.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
Why it matters
- Imaging-based risk markers in ICAS may refine selection for early intervention and monitoring [1].
- TEER platform competition could shift procedural workflows and procurement choices [2].
- AI-enabled CT and interventional imaging may lower dose while standardising quality across operators [3][6].
- Risk tools with 30-year horizons may change prevention engagement for younger adults and diverse populations [5].
- Novel anticoagulation and aldosterone synthase inhibition may reshape secondary prevention and hypertension care paths [7][8].
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FAQ
What distinguishes Dragonfly from MitraClip or Pascal?
Dragonfly (Valgen Medtech) is a TEER device for mitral and tricuspid repair. China 3-year and EU 6-month data suggest comparable performance to existing platforms, with shorter times at high-volume EU sites; operator preference may guide selection [2].
What did OCEANIC-STROKE report for asundexian?
Topline results show reduced ischemic stroke versus placebo on antiplatelets, with no observed increase in ISTH major bleeding. Full data are pending presentation; endpoints are specified at a high level in the source [7].
How is Optiq AI different from prior Siemens imaging chains?
It adds real-time AI denoising and automated exposure parameter optimisation to deliver high-quality, low-dose guidance across interventional modes on new Artis platforms, announced at RSNA [3].
What is baxdrostat’s FDA status and evidence base?
The FDA accepted the NDA for Priority Review for hard-to-control hypertension, supported by BaxHTN Phase 3 showing significant SBP reductions with a tolerability profile consistent with mechanism [8].
How should clinicians use PREVENT alongside CAC?
Use PREVENT for initial 10- and 30-year risk estimation and communication. CAC can refine individual risk when uncertainty persists, per JACC analyses, including external performance data in Korea [5].
Entities / Keywords
Intracranial atherosclerosis (ICAS); borderzone infarct; hypoperfusion mismatch; Valgen Medtech Dragonfly TEER; Abbott MitraClip; Edwards Pascal; Siemens Healthineers Optiq AI; Syngo.CT Coronary Cockpit; Artis genio/icono.explore/icono.vision; RSNA; Hamburg City Health Study; PREVENT equations; NHANES; CAC; Bayer asundexian (FXIa inhibitor); AstraZeneca baxdrostat (aldosterone synthase inhibitor) BaxHTN; Monash University; Yale School of Medicine; ARPA-H; BrightHeart AI; Mount Sinai; congenital heart defects.
References
- https://www.neurologyadvisor.com/news/impaired-perfusion-predicts-early-stroke-recurrence-symptomatic-icas/
- https://cardiovascularnews.com/latest-data-from-dragonfly-pivotal-studies-shared-at-pcr-london-valves/
- https://cardiovascularnews.com/siemens-launches-ai-powered-imaging-system-optiq-ai/
- https://cardiovascularnews.com/rsna-2025-abdominal-obesity-associated-with-harmful-changes-in-heart-structure/
- https://www.acc.org/Latest-in-Cardiology/Journal-Scans/2025/12/01/21/57/New-Research-Adds
- https://cardiovascularnews.com/new-imaging-tool-launched-to-aid-coronary-interventions/
- https://www.thecardiologyadvisor.com/news/asundexian-shows-promise-in-secondary-stroke-prevention/
- https://www.astrazeneca-us.com/media/press-releases/2025/Baxdrostat-New-Drug-Application-accepted-under-FDA-Priority-Review-in-the-US-for-patients-with-hard-to-control-hypertension.html
- https://www.monash.edu/news/articles/scientists-unlock-brains-natural-clean-up-system-to-develop-new-treatments-for-stroke-and-other-neurological-diseases
- https://www.news-medical.net/news/20251202/AI-assisted-ultrasounds-greatly-improve-detection-of-congenital-heart-defects.aspx