TAVI NEWS WEEKLY — 19 Oct 2026
1. What changed this week
[Edwards] FDA Early Alert (15 Oct): Edwards has asked customers to remove four lots of Commander M delivery systems used with the SAPIEN M3 transcatheter mitral valve, after three reports of balloons bursting during inflation. One death and one serious injury had been reported as of 5 Oct. Other lots can still be used, and Edwards told MedTech Dive (16 Oct) the four lots cover fewer than 200 systems. This is the mitral system, not SAPIEN 3 TAVR.
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[Other] EACTS 2026 (presented 9 Oct; TCTMD 16 Oct): Heuts et al. pooled PARTNER 3, Evolut Low Risk and NOTION (2,644 low-risk patients) in a time-dependent analysis. TAVI mortality was higher than SAVR between 5 and 7 years (HR 1.64; 95% CI 1.27–2.12), but the overall 7-year HR (1.14) was not significant, and the late difference lost significance when Evolut Low Risk was excluded (HR 1.39; 95% CI 0.96–2.01). Independent commentators called it preliminary and flagged differential loss to follow-up.
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[Market] MedAxiom 2026 Cardiovascular Provider Compensation and Production Survey (Cardiovascular Business, 15 Oct; 2025 data): median TAVR volume per full-time interventional cardiologist rose from 26 in 2016 to 47 in 2025, and cardiac CT and PET volumes grew substantially.
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2. Papers / congress abstracts to read
[Other] Diez-Delhoyo et al., REF-TAVR, JACC: Cardiovascular Interventions (shared by the lead author 15 Oct). In a Spanish multicentre registry with 466 propensity-matched pairs needing a pacemaker within 30 days of TAVR, conduction system pacing versus right ventricular pacing was associated with less cardiovascular death or HF hospitalisation at a median 24 months (9.7% vs 17.6%; HR 0.57), driven by HF hospitalisations, with no mortality difference. The authors call for randomised trials.
Source:
https://www.jacc.org/doi/10.1016/j.jcin.2026.08.008
[Other] PROLONG-TAVR systematic review and meta-analysis, Catheterization and Cardiovascular Interventions (14 Oct): 242 observational studies and 181,187 patients (published 2002 to May 2024). Short-term complications fell with newer-generation valves, pacemaker implantation remained the most frequent complication, moderate-or-greater PVL was more frequent with self-expanding valves, and stroke rates changed little.
Source:
https://doi.org/10.1002/ccd.70944
3. New Devices in Cardiology and Structural Heart
Nothing new this run.
4. Advances in Cardiology and Structural Heart Tech
[Other] Patel et al., JAMA (Mass General Brigham, 16 Oct): about 952,000 clinicians submitted about 271 million queries to the AI clinical platform OpenEvidence between Jan 2024 and Jun 2026, mostly on treatment and management rather than diagnosis. Cardiovascular Business broke out cardiology query patterns.
Source:
https://jamanetwork.com/journals/jama/fullarticle/2855491
5. Cardiology News
Structural Heart News: Nothing new this run beyond the items above.
Coronary Interventions:
[Other] Hanif et al., Catheterization and Cardiovascular Interventions (TCTMD, 14 Oct): in a TriNetX propensity-matched analysis (2,249 pairs) of NSTEMI patients with pre-existing stable HF, PCI within 24 hours was associated with a higher composite of death, HF exacerbation, recurrent MI or VT/VF at 1 month (RR 1.23) and 1 year (RR 1.12), mainly from MI. Observational; outside experts flagged HF coding limits.
Source:
https://www.tctmd.com/news/early-pci-tied-worse-outcomes-nstemi-patients-stable-hf
Devices: Nothing new this run beyond REF-TAVR (section 2).
Electrophysiology:
[Other] Xu et al., Frontiers in Cardiovascular Medicine (16 Oct): a sponsor-funded, single-arm, 10-centre Chinese study of a novel asymmetric biphasic pulsed field ablation system in paroxysmal AF. Of 105 treated patients, all had acute PVI and 69.5% were free from atrial arrhythmia at 12 months; there was one transient coronary vasospasm, silent cerebral lesions in two (1.9%), and common laboratory hemolysis without kidney injury.
Source:
https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2026.1945178/full
