Cardiovascular Update: Verquvo Miss, CPAP Rethink, nsPFA IDE and More
This week in cardiovascular news, we bring ESC 2025 headlines, disruptive devices, and smarter risk tools. From vericiguat’s paradox in stable HFrEF to phenotype-driven CPAP, oral PCSK9 in Phase 3, and a pivotal stem-cell trial in HLHS—here’s what matters now.
In Today’s Newsletter
🫀 Verquvo misses VICTOR composite in stable HFrEF; CV-death signal noted [1] [EU • 02 Sep 2025]
Context: Phase 3 VICTOR; >6,100 well-managed HFrEF; high GDMT/SGLT2 use; ESC 2025 with Lancet publication.
Key point: No benefit on primary (CV death/first HF hospitalization); numerical ~17% CV-death reduction; hospitalizations unchanged.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Sotagliflozin shows age-consistent HF/MACE reduction (SCORED + SOLOIST-WHF) [2] [EU • 02 Sep 2025]
Context: Lexicon-funded post-hoc pooled analysis (~11.8k pts); T2D with CKD or HF; ESC 2025 oral.
Key point: Consistent reductions in total CV-death/HF events and MACE across <65 and ≥65 years (HRs reported).
Implication: May influence prescriber choice and payer reviews pending full data.
🫁 CPAP cuts CV risk in high-risk OSA, may raise it in others (IPD meta-analysis) [3] [03 Sep 2025]
Context: Pooled individual-patient data from ISAACC, RICCADSA, SAVE (n=3,549); mean follow-up ~3 years.
Key point: Greater benefit in high-risk OSA; in non-high-risk (esp. non-sleepy), CPAP may increase serious CV events.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
💊 AZD0780 (AstraZeneca; oral PCSK9) Phase 3 MACE-PLUS update — ongoing [4] [06 Sep 2025]
Context: International, randomized DBPC trial in ASCVD/high-risk prevention; start 30 May 2025; update 04 Sep 2025.
Key point: No efficacy yet; trial continues assessing AZD0780’s impact on MACE-PLUS vs placebo.
Implication: Signals pipeline investment and modality expansion.
🦠 PARACHUTE-HF: first randomized trial in Chagas HF shows biomarker reduction [5] [EU • 06 Sep 2025]
https://coalicionchagas.org/en/great-findings-from-the-parachute-hf-trial-a-study-on-heart-failure-caused-by-chagas-disease/
Context: ESC 2025 presentation; Novartis + BCRI collaboration; chronic Chagas cardiomyopathy.
Key point: Reduction in a prognostic HF biomarker associated with lower CV risk (endpoint not specified).
Implication: May influence prescriber choice and payer reviews pending full data.
🧫 Systemic immune-inflammation index predicts adverse outcomes in HFpEF [6] [07 Sep 2025]
Context: Journal of Translational Medicine study; observational cohort; explores inflammatory pathways in HFpEF.
Key point: Higher SII associated with increased hospitalization and mortality in HFpEF.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧠 India completes first multicenter trial of Supernova stroke stent retriever [7] [IN • 07 Sep 2025]
https://www.healthcareradius.in/features/equipment-devices/stroke-stent-retriever-trial
Context: Gravity Medical Technology device; CK Birla Hospitals–CMRI among sites; focus on large-vessel occlusions.
Key point: Trial concluded; device aims to cut thrombectomy device costs by >50%; local manufacturing planned.
Implication: Introduces competition that may affect pricing and formulary access.
⚡️ FDA IDE clears nsPFA Cardiac Surgical System (NANOCLAMP AF) for AF ablation study [8] [US • 08 Sep 2025]
Context: Single-arm, prospective; up to 136 pts at ~20 sites (incl. ex-US); Breakthrough Device (Jul 2024).
Key point: Study to evaluate nonthermal nsPFA clamp during concomitant cardiac surgery for AF.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Neutrophil RELMγ/Resistin drives post-MI ventricular arrhythmias (Science) [9] [09 Sep 2025]
https://medicalxpress.com/news/2025-09-immune-defense-holes-heart-reveals.html
Context: Mass General Brigham–led preclinical/mechanistic study; mouse models + human infarct tissue expression.
Key point: Neutrophil-derived RELMγ perforates cardiomyocyte membranes; knockout cut VT burden ~12-fold in mice.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
👶 Lomecel-B (laromestrocel) pivotal HLHS Phase 2b under way in US infants [10] [US • 09 Sep 2025]
Context: ELPIS II randomized (n=40) at 12 US centers; intracardiac injections during Stage II surgery vs standard care.
Key point: Primary goals include survival/transplant-free status and RV function; early pilot (n=10) favorable vs historical.
Implication: May influence prescriber choice and payer reviews pending full data.
🧲 Quantitative LGE ≥7.2% on CMR predicts SCD risk in DCM [11] [CN • 09 Sep 2025]
Context: Radiology study; n=837 (retrospective + prospective); median follow-up ~58 months.
Key point: LGE extent ≥7.2% provided robust stratification for SCD-related events vs qualitative reads.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
Why it matters
Stable HFrEF paradox: VICTOR underscores composite-endpoint limits in highly treated HFrEF and the need to parse mortality vs hospitalization.
Precision cardiology: OSA phenotype, inflammatory indices (SII), and quantitative CMR (LGE%) sharpen risk and treatment selection.
Access & delivery: Indigenous stroke devices and nsPFA surgical tools may broaden availability and speed of advanced interventions.
Rare/structural heart disease: Pivotal HLHS cell therapy could alter outcomes where conventional surgeries have limited durability.
FAQ
What did VICTOR show for Verquvo (vericiguat)?
A Phase 3 in stable HFrEF missed the composite CV-death/first HF hospitalization, with a numerical CV-death reduction but no hospitalization benefit; findings presented at ESC 2025 with Lancet publication [1].
Does sotagliflozin benefit older adults similarly?
Yes—post-hoc pooled SCORED + SOLOIST-WHF (~11.8k pts) reported consistent reductions in HF/CV endpoints across <65 and ≥65 years (HRs reported) [2].
Should all OSA patients get CPAP for CV risk reduction?
Not necessarily. An IPD meta-analysis suggests benefit in high-risk OSA phenotypes but possible harm in others, especially nonsleepy patients—supporting phenotype-guided use [3].
What’s notable about Pulse Biosciences’ nsPFA IDE?
FDA cleared a single-arm study (up to 136 pts) evaluating a nonthermal clamp for surgical AF ablation; device has Breakthrough status and EU feasibility experience [8].
How can CMR guide DCM risk?
A Radiology study found LGE extent ≥7.2% better stratified SCD-related risk than qualitative reads, supporting quantitative thresholds in practice [11].
Entities / Keywords
Verquvo (vericiguat; Merck & Co./Bayer) • VICTOR • HFrEF • Sotagliflozin (Lexicon; dual SGLT1/2) • SCORED • SOLOIST-WHF • CPAP • OSA • AZD0780 (AstraZeneca; oral PCSK9) • PARACHUTE-HF • Chagas cardiomyopathy • Systemic immune-inflammation index (SII) • HFpEF • Supernova stent retriever (Gravity Medical Technology) • nsPFA Cardiac Surgical System; NANOCLAMP AF (Pulse Biosciences) • RELMγ / Resistin (RETN) • Ventricular tachycardia (VT) • Lomecel-B (laromestrocel; Longeveron) • HLHS • CMR • Late gadolinium enhancement (LGE) • Dilated cardiomyopathy (DCM)
References
https://bioengineer.org/systemic-immune-inflammation-index-predicts-heart-failure-risks/
https://www.healthcareradius.in/features/equipment-devices/stroke-stent-retriever-trial
https://medicalxpress.com/news/2025-09-immune-defense-holes-heart-reveals.html