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TCT 2024’s Top TAVR Studies | CCTA’s Big Day
November 4, 2024
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Together with
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“It seems that there’s no advantages to wait. This is important, especially in light of the natural history of AS.”
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Philippe Généreux, MD on the benefits of early TAVR.
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Surgeries & Interventions
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This year’s TCT conference saw a deluge of TAVR studies examining everything from the efficacy of valve designs to TAVR’s impact on aortic and tricuspid regurgitation.
Out of all these TAVR studies, the four that could have the greatest clinical impact focused on interventional timing and the risk of comorbidities and procedural complications.
The EARLY TAVR trial shined the brightest spotlight on TAVR timing, finding that earlier intervention in patients with asymptomatic severe AS may be more beneficial than watchful waiting.
- Patients who received early TAVR were 16% less likely to experience MACE and saw better heart function over a median of 3.8 years, which may be enough to challenge current guidelines that call for routine surveillance every 6 to 12 months.
Conversely, the similarly structured EVOLVED trial found that early TAVR failed to lower mortality risks in asymptomatic AS patients who had evidence of myocardial fibrosis (14% vs. 13% for conservative care).
- However, early TAVR could increase these patients’ healthspan thanks to better symptom control and fewer hospitalizations (6% vs. 17%).
The TAVR UNLOAD trial also found that there’s not much to gain by performing earlier TAVR in patients with HFrEF and moderate aortic stenosis.
- Earlier TAVR didn’t result in statistically better outcomes than clinical surveillance, but it did support a greater improvement in overall KCCQ scores (12.8 vs 3.2).
The PROTECTED TAVR trial rounded out the major TAVR late-breakers, finding that cerebral embolic protection’s benefits varied geographically, and somehow didn’t reduce overall strokes.
- The study revealed significant stroke risk reductions with U.S.-performed TAVRs (-50% overall, -73% disabling), but no stroke benefits when performed outside the U.S.
The Takeaway
In addition to highlighting the massive role that TAVR plays in interventional cardiology workloads, the major TCT2024 TAVR trials’ mixed results related to procedure timing and patient complications underscored just how important an individualized approach is for TAVR.
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- CCTA’s Reimbursement Boost: After years of rising volumes and declining payments, CMS will significantly increase CCTA reimbursements in January 2025, more than doubling outpatient payments to $386 (previously $175). The reimbursement hike was made possible by a new cardiac CT code, noting that CCTAs were previously billed the same as lower-cost chest CTs, making the heart exams unprofitable for many organizations.
- S1P’s AVD Potential: There’s no medication available to prevent aortic valve disease, but that could change thanks to a better understanding of how sphingosine-1-phosphate (S1P) impacts valvular calcification. A study in Circulation found that increased systemic or local S1P levels led to increased valvular calcification in mice, suggesting S1PR2 antagonists and SphK1 inhibitors could someday help treat AVD in humans.
- Innoventric Series B: Innoventric secured $28.5M in Series B funding to advance its cross-caval technology following a successful first-in-human trial in Europe. The Innoventric device addresses tricuspid regurgitation by replacing the native valve’s function and anchoring to the vena cava instead of the beating heart, resulting in a complete seal without the risk of detachment. The company plans to leverage the new funds to expand clinical trials and support regulatory approvals in the U.S. and Europe.
- Case Against Beta-Blockers Grows: Stunning results from a cohort analysis of the POISE Trial found that beta-blockers initiated within 30 days before surgery (but not anytime prior), any use within 30 days, and sustained use in the year leading up to surgery increased stroke risk by 25%, 17%, and 8%, respectively. The data further supports the case against beta-blocker overprescription that is now the focus of several trials.
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- ECG-Based AS Screening: Amid all of TCT 2024’s treatment-focused TAVR research, AccurKardia showed how ECG AI could help identify more patients with undiagnosed aortic stenosis and get them into a treatment path. The presentation highlighted AccurKardia’s AK-AVS solution and the ubiquity of ECG data, noting that AI-driven ECG aortic stenosis screening could lead to major reductions in mortality, delayed treatment costs, and underdiagnosis.
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- HeartLung’s FDA Clearance: HeartLung Technologies achieved FDA 510(k) clearance for its AutoChamber AI solution that flags enlarged heart chambers on non-contrast CT scans, including exams performed for non-cardiac purposes. Trained with millions of chest CTs, the software is able to diagnose asymptomatic patients that the naked eye fails to catch, allowing early detection of HF, AFib, and stroke risks. The AI-generated report uses color-coded percentiles and snapshots of the heart chambers for more patient-friendly explanations.
- FlowTriever for PE Treatment: In late-breaking results from the PEERLESS trial, patients with acute pulmonary embolism fared better when receiving thrombectomy with Inari Medical’s FlowTriever compared to catheter-directed thrombolysis. Using the FlowTriever resulted in lower clinical deterioration (1.8% vs 5.4%), lower ICU admission rates (41.6% vs 98.6%), shorter hospital stays (4.5 vs 5.3 overnights), and fewer 30-day readmissions (3.2% vs 7.9%). Some researchers aren’t convinced by the study’s win ratio, but PEERLESS II could change their minds.
- QFR Doesn’t Beat FFR: Serving as a reminder of the importance of trial size, new data from the FAVOR III Europe trial showed that quantitative flow ratio (QFR) pales in comparison to fractional flow reserve (FFR). Despite the hype, QFR imaging led to a 2.5% higher occurrence of MACE and 823 stents, compared to only 650 stents from FFR. The results contrast previous small trials and the FAVOR III China trial, which supported preprocedural QFR over angiography.
- CMS Moves Ahead on Medicare Cuts: CMS on Friday issued a final rule for its 2025 Medicare Physician Fee Schedule that keeps in place a 2.83% cut in the conversion factor for physician services. The cuts were widely criticized when they were announced in July, but CMS has resisted calls to reduce them. The fight against the cuts now moves to Congress, which in the past has reversed Medicare payment reductions through legislation.
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