TAVI NEWS WEEKLY — 9 Nov 2026
1. What changed this week
[MDT] SPYRAL AFFIRM (TCT, 3 Nov; Circ Cardiovasc Interv): the Symplicity Spyral renal denervation post-approval study met its 6-month primary endpoint, with office systolic BP down 18.2 mmHg, home BP down 9.4 mmHg and 24-hour ambulatory BP down 9.7 mmHg, no increase in antihypertensive medications, and a 2.1% composite safety event rate. FDA also approved a labelling update adding data in isolated systolic hypertension, CKD up to stage 3b and type 2 diabetes; the indication is unchanged.
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[Abbott] CROWN-MV pivotal trial (first enrolment announced 29 Oct; reported 5 Nov): Abbott began enrolling up to 585 patients in the US, Canada and Europe with moderate-to-severe or severe MR, or mitral annular calcification, who are not candidates for surgery or transcatheter repair, to test the investigational Cephea transseptal mitral valve.
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[Other] AHA Scientific Sessions 2026 (Chicago, 6–9 Nov) ran its late-breakers; the headline finding was that big biomarker reductions did not translate into fewer events (Lp(a) HORIZON, ZEUS).
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2. Papers / congress abstracts to read
[Other] Lp(a) HORIZON (AHA, 7 Nov; NEJM): pelacarsen cut Lp(a) by 78% in more than 8,300 patients with CVD, but MACE was unchanged (HR 1.02).
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[Other] ZEUS (AHA, 7 Nov; NEJM): ziltivekimab lowered free IL-6 by 76% and hsCRP by 64%, yet the primary endpoint was 17.6% vs 17.7% (HR 0.99).
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https://sessions.hub.heart.org/late-breaking-science/article/22978108/lessons-from-landmark-trials
[Other] STREAM (AHA, 7 Nov; NEJM): stopping statins in multimorbid older adults without CVD was noninferior to continuing for MACE or death at 2 years.
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3. New Devices in Cardiology and Structural Heart
[Other] GE HealthCare AutoAS (4 Nov): an FDA 510(k)-cleared, CE-marked AI tool on the Vscan Air SL handheld ultrasound that estimates whether moderate-to-severe aortic stenosis is present from at least two standard 2D views, with a confidence score. Rollout to existing subscribers is expected by end of November.
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[Other] Evident Vascular Guidance System (4 Nov): FDA 510(k) clearance for a flushless, AI-enabled IVUS platform for peripheral vascular interventions.
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4. Advances in Cardiology and Structural Heart Tech
[Other] PARAMOUNT (AHA, 7 Nov): the first randomised trial of AI-enabled coronary CT plaque-based care vs usual stress testing in about 530 symptomatic patients with suspected CAD met its 180-day hierarchical endpoint (win ratio 2.00), driven mainly by diagnostic certainty and LDL-C lowering, with fewer angiograms without revascularisation (38% vs 60%).
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https://cleerly.com/press/paramount-first-randomized-trial
5. Cardiology News
Structural Heart News: Nothing new this run.
Coronary Interventions:
[Other] ISCHEMIA-EXTEND (AHA, 7 Nov; JAMA): at a median 9 years, routine invasive management did not improve survival vs initial conservative management in chronic coronary disease (25.8% vs 26.9%, adjusted HR 0.97).
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https://jamanetwork.com/journals/jama/fullarticle/2856396
[Other] COURAGE 25-year follow-up (AHA, 7 Nov; JAMA research letter): in 959 linked VA participants, upfront PCI plus OMT did not lower death or MI vs OMT alone (HR 1.01).
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https://gpcardio.org/en/2026-11-07_courage-at-25-years/
Devices: Nothing new this run.
Electrophysiology:
[Other] COAST-AF (AHA, 8 Nov; JAMA): in about 500 persistent AF patients, adding low-voltage-area ablation to PVI did not reduce recurrence overall; in the prespecified subgroup with low-voltage areas, recurrence was 49.3% vs 69.2%.
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https://www.acc.org/latest-in-cardiology/articles/2026/11/06/14/37/sun-5pm-afib-aha-2026
[Other] SUPERIOR (AHA, 8 Nov): sacubitril/valsartan vs valsartan after AF ablation in 320 hypertensive patients lowered 12-month atrial arrhythmia recurrence (18% vs 28%) with similar BP reduction.
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[Other] Catheter Precision VIVO (2 Nov): FDA 510(k) expanded labelling for its non-invasive 3D VT-origin mapping system to patients with structural heart disease undergoing monomorphic VT ablation.
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