Luai Madanat, MD

The Rise of the Solo TAVR Operator: Alone, Unarmed, and Unafraid sciencedirect.com/science/ar… Written before CMS finalized its new TAVR NCD - I think CMS got some of it right, and one big thing wrong. Braasch et al looked at 400K Medicare TAVRs, 2016 to 2024. Surgical bailout in 0.56%, falling from 0.92% to 0.40%. Hospital SAVR volume, whether low, intermediate, or high, was not associated with mortality among patients requiring salvage surgery. The absence of an on-site surgeon is not the absence of rescue. Transfer systems exist. A growing share of catastrophic complications, including contained annular injury, tamponade, and device embolization, are now rescued in the cath lab, far from the OR. We have run this experiment before - PCI required on-site surgery on the same theory. CPORT-E: over 18k patients, 6-week mortality 0.9% vs 0.8%. MASS COMM: emergency surgery in 0.1% to 0.3%. PCI without on-site surgery became standard. Systems of care exists across the spectrum of CV care: cardiogenic shock, PE care etc. What CMS got right in the final NCD: TAVR may be performed by a single operator. The mandated dual-specialty evaluation is dropped and only the operator's visit is required. Hospital procedural volume requirements are removed. Asymptomatic severe AS is now covered under CED. Where CMS got it wrong: on-site cardiac surgery is retained. It compels the backup that is so rarely needed. A system of care with straightforward TAVRs being performed by ICs in non-surgical sites with affiliations for complex/transfers would've balanced access. However, CMS & cardiac societies chose politics over patients in the end. Proof: no requirement for on-site EP, though permanent pacing is the most common service after TAVR. No requirement for vascular surgery - much more valuable to a TAVR operator than CV surgery. The mandate is kept to protect physicians not patients. Morevover, medicare imposes no minimum-volume condition on SAVR, despite a median annual surgeon volume of 16 cases. Volume, staffing and heart team requirements get framed as safeguards of quality. But they are absent for the surgical equivalent. Let's be honest - that framing is a pretext for protecting case volume, referral patterns, and established programs. Legitimate interests, just not the ones a public payer is charged with protecting. CMS exists to serve beneficiaries. Its mandate is to protect patients, not programs or professions. Where a requirement principally constrains competition, restricts access, or entrenches incumbents without corresponding patient benefit, it should be removed. Politics over patients. The solo TAVR operator is not a threat to patients. It is the means of reaching them. Hardly unarmed: percutaneous rescue, disciplined case selection, a defined transfer network. CMS came some of the way. They didn't have the courage to do the right thing and patients will pay the price. doi.org/10.1016/j.jcin.2026.… @JACCJournals @SCAI @ACCinTouch @TCTMD @CRFheart @STS_CTsurgery @MayoClinicCV @rajivxgulati @SVRaoMD @drroxmehran @AjayKirtaneMD @mmamas1973 @rwyeh @adnanalkhouli @mirvatalasnag @jaygirimd @tjsimard @PietroDiSantoMD @OmarARazek @mandeep_mayo @willsuh76 @EleidMack @ChetRihal @MayraGuerreroMD @AbdullahAlabcha @aelsab @evandrofilhobr @Mahmoud_Ismayl @lamelaspablo #TAVR #TAVI