TCTMD’s Top 10 Most Popular Stories for August 2019

FDA news on TAVR for low-risk patients, paclitaxel PAD devices, and baroreflex activation in heart failure dominated this month.

TCTMD’s Top 10 Most Popular Stories for August 2019

Approvals, updates, and alerts from the US Food and Drug Administration made up nearly half of our top 10 stories this month, covering everything from TAVR’s low-risk expansion to the approval of the Barostim Neo baroreflex activation therapy device (CVRx) in advanced heart failure. Also making the list was a study on acute stent thrombosis with the Synergy stent (Boston Scientific), a feature story on structural heart fellowship programs, and the second in our “Off Script” series of first-person physician blogs, this one a defense of selfies and social media in medicine.

1) FDA Expands TAVR Indication to Low-Risk Patients

Both Evolut R and Evolut PRO (Medtronic), as well Sapien 3 (Edwards Lifesciences), received the expanded indication in the eagerly awaited announcement.

2) More Acute Stent Thrombosis With Synergy Stent in Bern PCI Registry

Does the abluminal surface, bioresorbable polymer, or patients’ risk profile explain this? One expert remains skeptical.

3) FDA Gives Eagerly Awaited Update on Mortality With Paclitaxel-Coated Devices in PAD

The new letter to providers confirms that manufacturers will modify labeling to address the mortality signal.

4) Structural Heart Hype: As Fellowship Programs Mushroom, Who’s Keeping Tabs on Quality and Numbers?

The allure of TAVR and left atrial appendage closure sways many trainees to sign on for an extra year, but programs are varied and jobs are few.

5) FDA Approves Baroreflex Activation Therapy Device for Advanced Heart Failure

The Barostim Neo system improved quality of life and exercise capacity in the pivotal BeAT-HF trial.

6) DAPA-HF: Dapagliflozin Scores a Win in Heart Failure

Topline results show the primary endpoint was met in this phase III trial, which included patients with and without diabetes.

7) Higher Mortality With Off-Pump CABG: EXCEL Analysis

Less complete revascularization of the lateral wall likely contributes to higher mortality with off-pump CABG, say experts.

8) FDA: Class I Recall for Burst Balloons With Sapien 3 Ultra Delivery System

No products are being pulled from the market; instead, users are told to deploy the valve using slow and continuous pressures.

9) New AHA Guidance on Omega-3 Fatty Acids for High Triglycerides

The scientific advisory zeros in on triglyceride effects and on newer prescription-strength products, as studied in REDUCE-IT.

10) #Selfies, Carrots, and Push-ups: A Defense of Social Media in Modern-Day Medicine

Kardashians, move over. Twitter is a vibrant community where physicians can connect, discuss, and collaborate with global peers.

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