Cardiovascular Update: Cardiovascular Aging Model, Next-Gen TAVR Platform and More
This week in cardiovascular news, we bring aging-centered care innovations, next-gen valve tech, life-saving stroke campaigns, and AI-powered tools. From Cleveland Clinic’s integrated geriatric-cardiology model to Edwards’ durable TAVR launch in India, Ireland’s stroke awareness push, and Medtronic’s pivotal HFpEF trial—here’s what matters now.
In Today’s Newsletter
🧓 Cleveland Clinic’s Cardiovascular Center on Aging model [1] [US • 10 Sep 2025]
https://consultqd.clevelandclinic.org/the-case-for-cardiovascular-centers-on-aging
Context: Multidisciplinary team rounds on high-risk inpatients; pipeline trials highlighted (LIVEBETTER; REHAB-HFpEF) and education/registry goals.
Key point: Viewpoint (JACC: Advances) and new clinic argue for integrated geriatric–cardiology care to improve outcomes in ≥75s with frailty/polypharmacy.
Implication: Access programs: May expand screening, initiation, and follow-up at scale.
🫀 Edwards launches next-gen TAVR platform in India [2] [India • 09 Sep 2025]
https://www.healthcareradius.in/features/technology/transcatheter
Context: Targets severe AS patients, including younger cohorts; enables lifetime “valve-in-valve” planning (comparators/endpoints not specified).
Key point: Balloon-expandable valve with calcification-resistant tissue, dry storage, taller skirt; company cites reduced PVL/mortality vs predecessors and 99.3% SVD-free at 7y.
Implication: Clinical topline/efficacy: May influence prescriber choice and payer reviews pending full data.
⏱️ Ireland’s HSE: “Every Second Counts” stroke campaign [3] [Ireland • 09 Sep 2025]
Context: ~7,500 strokes/year; ESD teams expanded to 11 sites, >800 beneficiaries (2023).
Key point: 3-year TV/radio/digital effort urges calling 999/112 at first FAST sign; aims to lift <50% 3-hour arrival rate.
Implication: Access programs: May expand screening, initiation, and follow-up at scale.
🚑 NEURESCUE wins CE Mark for non-shockable arrest [4] [Denmark • 09 Sep 2025]
Context: MDR review by TÜV SÜD; firm cites 100% procedural success by physicians in trials and ~5-min mean procedure (n not stated).
Key point: First device approved for non-shockable arrest; catheter balloon in descending aorta redirects flow to heart/brain during CPR.
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.
🧪 hsCRP flags risk in “SMuRF-less” women [5] [US • 10 Sep 2025]
Context: Quintile trend: rising hsCRP → higher CHD risk; ≥3 mg/L associated with higher CHD, ischemic stroke, and total CVD risk (estimates per article).
Key point: EHJ analysis (n=12,530; 30-year follow-up) links higher baseline hsCRP to increased CHD/stroke in women without HTN, dyslipidemia, diabetes, or smoking.
Implication: Observational/RWE: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
😴 Mount Sinai wins $3.32M NIH grant for AI OSA tool [6] [US • 10 Sep 2025]
Context: Will use RCT datasets to compare against AHI; aims for individualized treatment-effect estimates (causal framework).
Key point: 4-year R01 to validate transformer-based model predicting CV risk and treatment response to CPAP in OSA.
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.
💓 Medtronic starts ELEVATE-HFpEF pivotal RCT [7] [Ireland • 15 Sep 2025]
Context: First implants in Australia and US; intends to seek new pacing indication if positive (outcomes/endpoints not specified).
Key point: Randomized, double-blind, global study (n≤700) testing personalized elevated rates via conduction-system pacing vs backup pacing in HFpEF.
Implication: Clinical topline/efficacy: May influence prescriber choice and payer reviews pending full data.
🧷 TAVI vs SAVR in bicuspid AS: PCORI-funded RCT [8] [US • 16 Sep 2025]
Context: 6.5-year multicentre trial; addresses evidence gap for ~2% prevalence bicuspid anatomy.
Key point: Cedars-Sinai awarded US$26M (pending final review) to randomize ≥50-year-olds with bicuspid AS to TAVI or SAVR.
Implication: Observational/RWE: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧵 First-in-human Sutra Hemi-valve for mitral repair [9] [New Zealand • 16 Sep 2025]
https://cardiovascularnews.com/first-patient-receives-sutra-hemi-valve-mitral-repair-system/
Context: Waikato Hospital FIH; day-3 discharge reported (n=1).
Key point: Transfemoral, transseptal device reduced severe (4+) functional MR to trace–mild in an 83-year-old not suitable for surgery/TEER.
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.
📑 CORE-MD issues EU trial design guidance for high-risk devices [10] [EU • 16 Sep 2025]
Context: EU-funded consortium led by ESC/EFORT; aims to define “sufficient clinical evidence” under MDR.
Key point: Consensus in Lancet Regional Health Europe proposes four-stage framework, more RCTs (including sham), registry-embedded trials, and transparency.
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.
Why it matters
- Non-shockable arrest has lacked device options; CE Mark for NEURESCUE could reshape resuscitation pathways in Europe.
- HFpEF remains undertreated; pacing-based strategies (Medtronic) test a new physiologic avenue beyond drugs.
- India access to latest-gen TAVR may broaden minimally invasive options amid rising CVD burden.
- Bicuspid AS management lacks randomized evidence; PCORI trial may guide TAVI vs SAVR decisions.
- hsCRP offers a simple lab to risk-stratify “SMuRF-less” women, informing prevention earlier in life.
FAQ
What is NEURESCUE and who can use it?
A catheter-balloon system approved in the EU to treat non-shockable cardiac arrest by augmenting central perfusion during CPR; designed for use by clinicians and validated in simulated settings for paramedics/medics [4].
How is Medtronic’s ELEVATE-HFpEF trial designed?
Randomized, controlled, double-blind, multicentre (n≤700) comparing personalized conduction-system pacing vs backup pacing in HFpEF patients without a pacing indication; first implants in Australia and the US [7].
Does hsCRP meaningfully stratify risk in healthy women?
In 12,530 initially healthy US women followed for 30 years, higher baseline hsCRP associated with higher CHD and ischemic stroke risk despite no standard modifiable risk factors; effect sizes reported by HealthDay summarizing EHJ data [5].
What’s new about Edwards’ TAVR platform in India?
Company highlights calcification-resistant tissue, taller sealing skirt, dry storage, and durability claims (e.g., 99.3% SVD-free at 7 years); comparative endpoints vs competitors not specified in the article [2].
How will the Cedars-Sinai/PCORI study affect bicuspid AS care?
A long-horizon RCT will directly compare TAVI vs SAVR in patients ≥50 with bicuspid valves, addressing a major evidence gap; funding is approved pending final contracting [8].
What does CORE-MD recommend for EU device trials?
A four-stage evidence framework, greater use of randomized (incl. sham) and registry-embedded trials, and mandatory transparency to define “sufficient clinical evidence” for high-risk devices under MDR [10].
Entities / Keywords
Neurescue (NEURESCUE device); Medtronic (ELEVATE-HFpEF; conduction-system pacing); Edwards Lifesciences (balloon-expandable TAVR; calcification-resistant tissue); Cedars-Sinai / PCORI (bicuspid AS RCT; TAVI vs SAVR); Cleveland Clinic (Cardiovascular Center on Aging); HSE Ireland (Every Second Counts; FAST); hsCRP (SMuRF-less risk; European Heart Journal); Mount Sinai (AI OSA tool; CPAP; transformers); Sutra Medical (Hemi-valve; mitral repair); CORE-MD / ESC / EFORT (EU MDR clinical evidence).
References
https://consultqd.clevelandclinic.org/the-case-for-cardiovascular-centers-on-aging
https://www.healthcareradius.in/features/technology/transcatheter
https://cardiovascularnews.com/first-patient-receives-sutra-hemi-valve-mitral-repair-system/