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TAVR Trends, FDA Shake-Up, and HF Research
May 14, 2026
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Together with
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“We live with the frustrating inelegance of fruitless readmissions for days or weeks, but the patient and their family live with the end-of-life experience forever.”
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Michelle Kittleson, M.D. on end-of-life care in heart failure.
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This TAVR vs. SAVR debate is one we cover often. Mostly because it’s one in which the data consistently point one way, and practice is headed the other way.
Curious to hear your thoughts and thanks for reading!
Cheers, Vik
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Despite a TAVR popularity surge in recent years, a Vizient registry analysis suggests the procedure’s prevalence has stabilized in patients under 65, but there’s still significant debate on whether the young patient TAVR rate is appropriate.
- U.S. and EU guidelines currently recommend SAVR over TAVR for patients younger than 65 given the lack of long-term durability data and decades of remaining life expectancy.
- TAVR in younger patients has been the center of intense debate over the last few years, with some observational studies suggesting TAVR now makes up 50% of AVRs under 65.
Getting to the bottom of the TAVR question, researchers examined aortic valve replacement procedures in under-65 patients from 2016-2024 and found an unexpected plateau…
- TAVR volumes grew exponentially through 2020 reaching 36.8% of all procedures while isolated SAVR declined to 27.4%.
- However, between 2020-2024 the TAVR rate reversed and stabilized around 29%.
- Intriguingly, the Ross procedure grew steadily from 0.4% in 2016 to 4.8% in 2024.
While that TAVR rate of 29% comes in well below the 50% that observational studies predicted, it still seems high considering that SAVR is a class I recommendation for patients under 65.
- This trend is especially concerning given that recent studies on valve-in-valve repair also show worse outcomes than redo SAVR.
One encouraging trend from the study is that concomitant SAVR rates (ascending aorta, CABG, MVR, etc.) remained stable throughout the study period.
- Concomitant SAVR rates peaked in 2017 at 40.4% and nudged down to 34.3% in 2021.
The Takeaway
A brilliant cardiologist once warned that TAVR-ing the masses could have consequences, and while the minimally invasive procedure has its benefits, this study does remind us that it can be over-used in the wrong patient group.
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- Acoramidis’ Clinical Outcomes: BridgeBio Pharma announced new Phase 3 ATTRibute-CM data that suggests acoramidis can achieve near-complete transthyretin stabilization in ATTR-CM patients. The study found that acoramidis significantly reduced an individual’s serum TTR variability compared to placebo (9.5% vs. 12.8%), which is independently associated with reduced all-cause mortality (HR: 0.56). Clinical results showed a 41% reduction in outpatient worsening HF and a 34% reduction in CV hospitalizations for patients on acoramidis.
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- Monitoring Reduces Post-TAVR Cardiac Events: An analysis from the RECORD registry found that 14-day systematic ambulatory ECG monitoring post-TAVR significantly reduces life-threatening CV events compared to standard care. At one year, the study’s composite endpoint of sudden cardiac death, arrhythmic syncope, or stroke was 1.9% in the monitoring group versus 6.6% in the control arm. While pacemaker implantation rates were similar between groups (4.7% vs. 5.5%), the monitoring group received interventions nearly 80 days earlier on average.
- Diuretic Resistance Leads to Poor Outcomes: A post hoc analysis of the TRANSFORM-HF trial found that patients with a high risk of diuretic resistance fare worse regardless of what loop diuretic they receive (furosemide or torsemide). Among the study’s 2.4k participants, those identified as high risk for diuretic resistance saw significantly higher adjusted rates of all-cause mortality (HR: 1.79) and hospitalization (HR: 1.34) compared to low-risk patients. Researchers suggested this means finding an alternate decongestion method is better than selecting a loop diuretic class for high-risk patients.
- Novo Rebrands Rybelsus as Ozempic Pill: Novo Nordisk is retiring the Rybelsus name in the U.S., transitioning its oral semaglutide formulation into the “Ozempic pill” to leverage the newfound brand’s cultural recognition. The relaunch features a newly tweaked, smaller tablet with improved bioavailability, in 1.5mg, 4mg, and 9mg doses that are equivalent to the older 3mg, 7mg, and 14mg Rybelsus strengths. To ensure supply stability, the company is manufacturing the pill end-to-end in the United States and officially began the rollout on May 4, 2026.
- Unnecessary Vascular Procedure Fraud: Serrano Kidney & Vascular Access Center agreed to pay $6.7M to resolve DOJ allegations of submitting false claims for medically unnecessary vascular interventions. The settlement addresses claims that from 2016 to 2024, Serrano performed excessive dialysis access procedures and peripheral artery disease interventions on Medicare patients, including one case where a patient received 42 stents over eight years. Serrano allegedly falsified documentation and misled patients regarding amputation risks to justify billing for asymptomatic limbs.
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- FDA Turmoil Continues: Ongoing turmoil at the FDA continued this week with the departure of Commissioner Marty Makary, MD. Makary’s departure had been rumored for weeks as he was buffeted between the FDA’s traditional role in regulating the food and medical industries and demands for more rapid change by the Make America Healthy Again movement. Makary also presided over a year of personnel cuts that slashed the FDA’s workforce up to 21%, resulting in plummeting morale among the staffers remaining.
- J&J Launches Next-Gen Shockwave: Johnson & Johnson announced the global launch of the Shockwave C2 Aero Coronary IVL Catheter, the fifth-generation platform in its intravascular lithotripsy portfolio. Designed for complex calcified coronary artery disease, the new device features a more flexible shaft and tapered tip to improve deliverability and lesion crossing in twisted anatomy. It also includes a new hydrophilic coating and balloon material that enables deflation for easier repositioning within the vessel while delivering up to 240 shockwaves across 120 pulses.
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