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TEER for AFMR, Recall Rampage, and Plane Noise BP
August 14, 2025
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Together with
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Surgeries & Interventions
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Shedding light on a new treatment for an understudied condition, data published in EHJ suggests that transcatheter edge-to-edge repair (TEER) delivers significant survival advantages in patients with atrial functional mitral regurgitation (FMR).
- Atrial FMR is increasingly recognized as an important consequence of chronic atrial fibrillation, affecting older patients with limited therapeutic options.
- The previous COAPT and RESHAPE-HF2 trials only established TEER’s benefits in ventricular FMR patients, but hadn’t explored its impact in atrial FMR.
The new OCEAN-Mitral/REVEAL-AFMR Analysis compared 441 TEER-treated patients against 640 medically managed controls with moderate or severe atrial FMR, stating a solid case for TEER…
- Primary endpoint risk (death + HF hospitalization) was 35% lower with TEER.
- All-cause mortality alone dropped by 42% with intervention.
Beyond meeting survival endpoints, TEER demonstrated progressive benefits over time and superior procedural outcomes, including…
- Far lower primary endpoint rates at 3 years (21.0% vs. 44.3%).
- Residual MR reduced to mild or less in 78.3% of patients at discharge.
- Procedural success rate of 95.2% with only 2.9% device-related complications.
So what do we do with these strong results? Researchers suggest emphasizing careful patient selection and TEER procedural optimization for this high-risk population such as…
- Targeting patients failing standard HF therapy who are functionally limited yet open to intervention.
- Selection based on MR severity, comorbidities, and left atrial size before extreme enlargement.
- Preprocedural echo assessment for identifying procedural difficulty factors.
The Takeaway
This registry analysis provides the first dedicated evidence that TEER can deliver striking mortality benefits in atrial FMR, a complex condition where effective medical therapies are still limited. However, it’s still only an observational study, so randomized trials will be needed to definitively prove this procedure’s role in atrial FMR treatment.
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- Conformal’s Series D: Conformal Medical closed a $32M Series D extension to support its CONFORM Pivotal Trial and pre-commercialization of its CLAAS AcuFORM left atrial appendage occlusion system. The 1,600-patient trial, now >30% enrolled, compares AcuFORM to existing LAAO devices to support its FDA approval. Over 100 patients have been treated with the foam-based device, which uses only two sizes and may enable ICE guidance, potentially eliminating general anesthesia for atrial fibrillation stroke prevention procedures.
- Stand-Up More, Not Sit Less: Standing up more often could be better for your body than just sitting less, especially if you’re an older woman. A 3-month trial of 407 overweight/obese postmenopausal women compared a “sit less” group to a “sit-to-stand transitions” group and found that the “sit less” group reduced sitting time by 58 minutes daily but showed no blood pressure improvements. Meanwhile, the “sit-to-stand transitions” group increased stand-ups by 26 per day without reducing total sitting time, yet significantly lowered diastolic blood pressure.
- Medline EP Catheter Recall: Medline ReNewal recalled specific lots of reprocessed St. Jude Medical electrophysiology catheters due to potential residual particulates that could cause inflammatory responses, infections, or blood clots leading to embolism or thrombosis. The FDA issued this warning though no serious injuries or deaths have been reported. The company states that customers must quarantine these devices immediately.
- Boston Scientific Watchman Warning: The FDA warned that Boston Scientific’s Watchman device has heightened air embolism risk during implantation without positive pressure-controlled ventilation. Air embolism, while rare, can be fatal and the risk of it occurring is three times higher with conscious/deep sedation during transseptal procedures. As of July 30, this issue caused 120 serious injuries and 17 deaths. Boston Scientific is updating instructions and physician training for multiple access systems used in atrial fibrillation patients.
- BSCI Reliance Alert: The FDA also issued an alert about Boston Scientific’s Reliance defibrillation leads with ePTFE coating, which may develop rising low-voltage shock impedance due to calcification. This issue reduces effectiveness over time and currently affects leads manufactured from 2002 to 2021, with approximately 354k still in service. As of July 24, there were 386 serious injuries and 16 deaths reported. The most serious harm is death from non-conversion of ventricular arrhythmias due to reduced shock energy from high impedance.
- CCTA vs. TEE for Checking LAAO: A meta-analysis in Circulation: Cardiovascular Imaging found that CCTA could be more effective than transesophageal echocardiography (TEE) for detecting residual leaks after left atrial appendage occlusion. Researchers examined data from 1.3k patients across 17 studies, uncovering that CCTA detected more residual peridevice leaks (58.8% vs. 34.6%) and any peridevice leaks (51.6% vs. 35.5%) compared to TEE. CCTA also offered better spatial resolution, was less invasive, faster, operator-independent, and avoided sedation/intubation risks compared to TEE.
- BiVACOR TAH gets TAPped: BiVACOR’s titanium Total Artificial Heart (TAH) was accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP), following its earlier Breakthrough Device designation. The TAP program provides strategic FDA engagement throughout development and commercialization for high-impact medical technologies, like the titanium TAH. And it’s for good reason that the FDA is backing this tech, since BiVACOR’s pump system is intended as a bridge to transplant for severe HF patients who can’t use traditional LVADs.
- Oral GLP-1 Win for Lilly: Eli Lilly announced positive Phase 3 ATTAIN-1 trial results for orforglipron, its investigational oral GLP-1. Tested in over 3,000 adults, the highest orforglipron dose (36mg) achieved 12.4% weight loss (27.3 lbs) versus 0.9% with placebo at 72 weeks. Nearly 60% of participants lost ≥10% body weight, and 40% lost ≥15%. Lilly plans regulatory submission by year-end for this once-daily oral alternative to injectable obesity treatments.
- Noisy Planes Raise BP: A meta-analysis covering 35.5M adults found that aircraft noise exposure significantly increases cardiovascular disease risk, with stronger effects during nighttime. Across the adults studied, aircraft noise was linked to increased CVD mortality (OR: 1.07) and MI deaths (OR: 1.07) with men showing higher hypertension risk than women. Noise exposure also raised systolic blood pressure by 1.83 mmHg.
- What’s in Your Stockings? Could stockings help prevent vasovagal syncope? – Probably not. An RCT of 266 adults with vasovagal syncope (VVS) compared thigh-high elastic compression stockings versus “fake” stockings over 12 months and found that VVS recurred in 29.1% of treatment participants compared to 34.8% of the control group, which was not statistically significant. However, significantly fewer episodes occurred in patients who were actively wearing stockings (32.7% vs 45.1%).
- Elucid PlaqueIQ Notches Coverage Win: Insurance giant UnitedHealthcare has begun covering arterial plaque quantification from CCTA exams, a move that’s being praised by cardiac AI developer Elucid, which markets the PlaqueIQ solution. UnitedHealthcare’s new guidelines will apply to all health plans starting October 1. This marks a second milestone for plaque analysis developers after CMS proposed a Category I CPT code for CCTA with plaque analysis in its 2026 Medicare Physician Fee Schedule.
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