Dr John M

cardiac electrophysiologist, cyclist, learner

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Attempts to make AF ablation easier foiled by safety concerns

November 8, 2011 By Dr John

PVAC catheter

There is more bad news for the newest atrial fibrillation ablation tool–Medtronic’s Ablation Frontiers catheter-ablation system. After an overly positive press release last month, I wrote about the system’s safety issues.

Namely, that although effective, the multi-electrode PVAC circular ablation catheter was associated with an increased risk of stroke. Previous studies on the catheter showed much higher rates of new lesions on brain scans after AF-ablation. The problem in a nutshell is that the catheter allows clots to form on its electrodes. And these clots can travel northward to the brain.

Two weeks ago, as reported on TheHeart.org, an FDA panel recommended (9-1) against approval of the device, because of these safety concerns.

Now it looks like stroke concerns are only one problem with PVAC; the other is pulmonary vein stenosis—a dreaded complication of AF ablation. Ablation within the orifice of the pulmonary veins may cause damage that later obstructs blood flow out of the lungs.

In this published-before-print version of the journal, Circulation Arrhythmia and Electrophysiology, Belgian researchers showed striking increases in PV stenosis risk in 50 patients that underwent ablation with the PVAC catheter. They report:

  • Moderate PV narrowing occurred in 78% of patients;
  • Severe narrowing occurred in 15% of patients.

Not good.

The search to make AF ablation easier—and safer—continues.

AF ablation is clearly in a plateau phase of technology.

Robots haven’t worked.

Big, bulky cryo-ablation balloons don’t look to be revolutionary either. Think long learning curves, stiff sheaths and expensive capital investments.

Ablating AF is as it has been for years now. Successful outcomes are dependent on skilled human operators whose neural pathways have been honed after much experience. And of course it isn’t just skill moving a catheter; it’s the judgment to select patients most apt to respond to such an aggressive therapy.

Alas…it’s the human stuff!

Though I look forward to technology that makes AF ablation easier, safer and more effective, I revel in the impermanent ownership of at least one somewhat novel skill set.

JMM

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Related posts:

  1. AF ablation news: Don’t get too excited by press releases
  2. Changing trends in the treatment of AF
  3. Laser energy: a new tool for AF-ablation?
  4. Atrial fibrillation ablation in the news. Some good science…

Filed Under: AF ablation, Atrial fibrillation

John Mandrola, MD

Welcome, Enjoy, Interact. john-mandrola I am a cardiac electrophysiologist practicing in Louisville KY. I am also a husband to a palliative care doctor, a father, a bike racer, and a regular columnist at theHeart.org | Medscape

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  • Electrophysiology commentary on Medscape/Cardiology

Mandrola on Medscape

  • My Medscape column on general medical matters

For patients...Educational posts

  • 13 things to know about Atrial Fibrillation — 2014
  • A new cure of AF
  • Adding a new verb to doctoring: To deprescribe is to do a lot
  • AF ablation — 2015 A Cautionary Note
  • AF Ablation in 2012–An easier journey?
  • Atrial Flutter — 15 facts you may want to know.
  • Benign PVCs: A heart rhythm doctor’s approach.
  • Caution with early Cardioversion
  • Decisions of 2 low-risk cases of PAF
  • Defining success in AF ablation in 2014
  • Four commonly asked questions on AF ablation
  • Inflammation and AF — Get off the gas
  • Ten things to expect after AF ablation
  • The medical decsion as a gamble
  • The most important verb in our health crisis
  • Wellness Requires Ownership

 

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