TCTMD’s Top 10 Most Popular Stories for June 2019
TAVR topics plus the FDA efforts to plumb the mortality signal with paclitaxel-based PAD devices dominated this month’s list.
The US Food and Drug Administration’s deep dive into the mortality signal with paclitaxel-based devices for PAD topped our most popular stories this month, but a range of TAVR stories also made the list—not surprisingly, given the timing of the TVT 2019 meeting. TAVR topics in the top 10 this month included the final Centers for Medicare & Medicaid Services coverage decision, vascular closure postprocedure, concomitant use of non-vitamin K antagonist oral anticoagulants (NOACs), operator requirements, and undertreatment of aortic stenosis. The outlier for June 2019: a story carried over from the European Atherosclerosis Society meeting looking at whether or not to measure and treat lipoprotein(a).
1) FDA Review Affirms Mortality Signal With Paclitaxel-Based Devices for PAD Ahead of Panel Meeting
The 2-day meeting of the Circulatory System Devices Panel was expected to debate next steps and possible regulatory actions.
2) FDA Panel Talks Labeling, Urges Cooperation for Paclitaxel Mortality Signal in PAD
The data are a mess, and more uniformity is needed in clinical trials going forward. So concluded some “inconclusive” debate.
3) TAVR Operators: Can One Do It All or Are Two Still Justified?
A debate at SCAI delved into contemporary TAVR practice and whether the mandate to involve surgeons remains necessary.
4) FDA Advisors Face ‘Forest of Dueling Numbers’ at Paclitaxel PAD Device Review: Day One
The agency’s advisory committee grilled the agency and sponsors on their data, while emphasizing practicalities in treating PAD.
5) ProGlide Comes Out Ahead of Prostar in Vascular Closure After Transfemoral TAVR: BRAVO 3
Still, as many as one in four patients are afflicted by vascular complications following TAVR, experts note.
6) Real-world Stroke With TAVR: TVT Registry Insights Rekindle Cerebral Protection Debate
A 6-year registry snapshot hints that TAVR stroke rates have been stable, spurring questions for low-risk patients and brain debris.
7) CMS Releases Final Decision Memo on Rules for TAVR Program Reimbursement
After a yearlong review and wide-ranging debate over volume and outcomes, CMS has finalized its stance on TAVR payments.
8) Should Lp(a) Be Measured and Treated? Two Experts Hash Out Its Current Role
Researchers debated the merits of lipoprotein(a)—while one sees the future, another argued in favor of sticking with LDL cholesterol.
9) Vast Numbers of Severe Symptomatic AS Patients Untreated? A Plea and Some Pushback
By one estimate, 65% don’t get referred for aortic valve replacement, posing questions for who and how to track patients with early aortic stenosis.
10) Potential Warning Signs Seen for NOAC Use After TAVR
Bleedings risks were similar with NOACs and vitamin K antagonists in a registry study, but ischemic risks were higher with the newer agents.
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TCTMD’s in-depth feature stories this month Anticoagulation On Demand? The Pill-in-the-Pocket Approach to A-fib Treatment The strategy aims to leverage advancements in pharmacology and technology to fundamentally change how A-fib is managed. At the ESC Heart Failure Congress, Some COAPT Converts—and Some Pushback Still in question is how much a MitraClip will truly help a patient for whom heart failure is his or her primary problem. |
Shelley Wood is Managing Editor of TCTMD and the Editorial Director at CRF. She did her undergraduate degree at McGill…
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