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TAVR Outcomes Shrug Off CAD, FDA Clearances, and Low IC Match Rates
December 11, 2025
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“Words matter. When we write ‘patient is stable,’ we often give ourselves permission not to move. No urgency to reassess risk, no pressure to escalate disease-modifying therapy… Better language: ‘Despite patient feeling generally well, he/she remains at high residual risk of CV events, including CV death…’ That wording keeps the urgency where it belongs.”

Andrew J. Sauer, MD

Surgeries & Interventions

CAD and Treating it With PCI has No Impact on TAVR

New post-hoc results from SCOPE I suggest that patients who have obstructive coronary artery disease as well as symptomatic severe aortic stenosis have similar outcomes to patients without CAD three years after TAVR. The study also suggests performing PCI in parallel to TAVR provides no benefit to these patients.

  • Obstructive CAD is present in over half of TAVR candidates, which has led to a debate about the best way to treat patients with both severe AS and CAD.
  • Although TAVR is non-invasive, many interventionists follow the mentality of concomitant SAVR + CABG and perform PCI while they’re performing TAVR.

But does the presence of CAD and treating it with PCI make a difference on TAVR outcomes? To answer this, researchers compared outcomes between 373 TAVR patients with obstructive CAD (38.6% of which received PCI during TAVR) versus 359 without CAD over a three-year follow-up and found that…

  • Quality of life improvements were similar regardless of CAD presence, with average KCCQ scores rising from 54.2 to 79.7 with CAD versus 55.2 to 82.3 without CAD.
  • All-cause and cardiovascular mortality were also the same between the two groups.
  • Trends toward higher MI (5.5% vs 1.1%) and unplanned PCI (2.2% vs 0.3%) risks were present in CAD patients, but not statistically significant.
  • Among CAD patients, receiving PCI didn’t improve TAVR outcomes, and they faced a higher bleeding risk (aHR: 1.7).

On the aortic stenosis side, these results tell us that even though CAD is common in TAVR patients, it doesn’t impact the overall value of valve replacement.

On the PCI side, the lack of a clear benefit to performing PCIs alongside TAVR might mean that it’s worth reconsidering revascularization as a routine procedure and moving toward a more selective approach based on patient characteristics.

What this study doesn’t tell us is whether PCI should come before, be combined with, or performed after TAVR, and the answer could very well depend on the individual patient.

The Takeaway

Although treating severe aortic stenosis is inherently complicated and accounting for obstructive CAD makes it even more challenging, this study tells us that TAVR is just as valuable to a patient’s quality of life regardless of the presence of CAD and whether or not it’s treated with PCI.

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The Wire

  • Vektor’s vMap Notches New FDA Clearance: Vektor Medical received an expanded FDA 510(k) clearance for its vMap cardiac mapping technology that includes new features like atrial flutter mapping, direct ECG streaming, and 3D visualization. vMap works by processing 12-lead ECG data to generate 2D/3D cardiac maps that identify arrhythmias and their source locations across the heart. The clearance also categorizes the vMap under Software as a Medical Device, which eliminates custom hardware requirements. Vektor will launch the technology to U.S customers in the coming months. 
  • FFR Can Predict PCI Success: A recent JACC study suggests that measuring fractional flow reserve (FFR) after PCI could be a valuable way to predict a patient’s long-term outcomes and complication risks. Researchers used FFR to evaluate 2.1k patients who received a drug-eluting stent over five years and found that those with low FFR values post procedure had a significantly increased risk of target vessel failure compared to those with high FFR values (aHR: 1.95).
  • Myocarditis, DCM, and Genetics: New research suggests it might be worth screening for genetic mutations in children with myocarditis and dilated cardiomyopathy (DCM). Researchers examined children with myocarditis-related DCM and compared them to children with DCM alone and controls, finding that among 32 myocarditis-related DCM patients, 34.4% carried rare, damaging genetic mutations compared to 6.3% in controls. These results suggest that although we think of myocarditis-related DCM as a secondary cardiomyopathy, a patient’s genetics could play a bigger role than expected.
  • HeartBeam Overturns NSE: HeartBeam received FDA 510(k) clearance for its 12-lead ECG synthesis software following a successful appeal of the FDA’s Not Substantially Equivalent (NSE) decision in November. The company’s software is used in tandem with its credit-card-sized, portable device that captures heart signals and synthesizes them into 12-lead ECG representations that are reviewed by board-certified cardiologists on-demand. HeartBeam plans a limited launch in early 2026 with select cardiology practices, while pursuing an MI detection indication and developing an extended-wear prototype.
  • Interventional Cardiology isn’t Attractive? The 2025 Interventional Cardiology Fellowship Match saw 236 of 244 applicants (97%) successfully match, but 71 positions remained unfilled across 49 programs due to a lack of applicants. SCAI believes this is due to a shrinking trainee pipeline rather than Match process failure, with factors that push applicants always such as: radiation exposure, orthopedic strain, demanding call schedules, burnout, and career longevity issues.
  • cTnT Type Matters for MI Diagnosis: A recent EHJ study suggests that measuring intact cardiac troponin T (long cTnT) improves heart attack diagnosis compared to standard total cTnT tests. Among the study’s 1.8k patients whose cTnT levels were measured, 205 experienced myocardial infarction, including 148 type 1 MI cases. Researchers found that focusing on long cTnT worked better for identifying MI than focusing on total cTnT levels (AUC .83 vs .78 for any MI; .84 vs .78 for type 1 MI). Meanwhile, only 0.7% of patients in the lowest long cTnT category had type 1 myocardial infarction.
  • RSV’s CV Implications: Respiratory syncytial virus might be just as bad as the flu when it comes to its impact on heart health. Danish researchers examined 17.5k adults aged 45+ and found that RSV led to 4.69 additional CV events per 100 people within one year, including ischemic heart disease, stroke, heart failure, and arrhythmias, with half of these events occurring within 30 days. Hospitalized elderly patients with preexisting CVD or diabetes faced the highest risk increases (+6.61% to 11.95%).
  • FDA isn’t Convinced by V-Wave: An FDA advisory committee unanimously voted against the Ventura (J&J V-Wave) interatrial shunt system’s efficacy and benefit-risk balance for heart failure. The FDA’s decision stems from the RELIEVE-HF trial, which failed its primary composite endpoint, even though post-hoc analyses suggested potential benefit in HFrEF patients but harm in HFpEF. However, the panelists caught onto this and criticized the extensive statistical analyses for seeking significance after primary endpoint failure, expressing concerns about providing “false hope” without definitive benefit.
  • PCI Timing Matters for Chronic Blockages: New results from the STAR trial suggest an earlier approach could be better when using PCI for treating long-lasting, complete blockages in arteries. STAR randomized 150 patients with complex chronic total occlusions who received “bailout” PCI after staged procedures at either 5-7 or 12-14 weeks, finding that earlier intervention led to better TIMI flow at the procedure’s start (64.4% vs 44.2%), while MACCE rates were similar between both groups. These findings contradict previous beliefs about waiting 60+ days prior to PCI.
  • Cereno Starts CS1 Trial: Cereno Scientific earned FDA clearance to begin the Phase IIb trial of its pulmonary arterial hypertension drug, CS1, that works by switching a patient’s genes on and off. The trial will enroll approximately 126 patients at 65 sites across 10-12 countries to evaluate CS1’s effect on pulmonary vascular resistance and 6-minute walk distance. Cereno’s CS1 already has Orphan Drug and Fast Track designations, with first patient enrollment planned for Q2 2026.
  • FDA Clears Atraverse’ Transseptal System: The FDA granted 510(k) clearance to Atraverse Medical’s HOTWIRE Transseptal Access System for left-heart access. The system includes a built-in radiofrequency generator that uses the wire’s electrical resistance to shut off and prevent tissue damage while crossing the heart’s septum. The system also uses the HOTWIRE RF Guidewire (cleared in May 2024) to provide zero-exchange access, works with any sheath, improves echocardiographic visibility, and offers twice the rail stiffness of competitors.

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The Resource Wire

  • Heartflow Roadmap Analysis For Efficient Care: As Coronary CT scan volumes increase, your entire reading team needs to deliver efficient and consistent reads. Good thing Heartflow’s Roadmap Analysis can help you maintain accuracy and increase CCTA read speeds by up to 25%, with even level 3 readers seeing real efficiency benefits.
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The Industry Wire

  1. Trump weighs AI executive order.
  2. 57 health systems ask HHS to rescind cybersecurity rule.
  3. AHA provides resources to detect deepfake AI schemes.
  4. Country’s biggest all-electric hospital set to open in California.
  5. Kaiser Permanente creates new C-suite role for care delivery.
  6. CIOs wield a powerful growth lever for health systems.
  7. HHS unveils overhauled AI strategy.
  8. Patients uploading sensitive medical records to ChatGPT.
  9. Social worker dies after stabbing at San Francisco hospital.
  10. New York-Presbyterian names new Chief Operating Officer.