2. HRS 2012 Research Highlights
The Heart Rhythm Society (HRS) 2012 Scientific Sessions took
place in Boston, MA from May 9 through May 12, 2012.
Key presentations at the sessions included:
Riata ICD lead safety: Attendance was off the charts at the headliner
event
RAAFT 2: RF catheter ablation with pulmonary vein isolation is more
likely to suppress AF recurrences than standard drug therapy
Founder's Lectureship Award: HRS 2012 recipient Dr Michel
HaÏssaguerre
FIRM ablation: Patients who have undergone focal impulse and rotor
modulation (FIRM) ablation in addition to standard pulmonary vein
isolation (PVI) remain AF free more often than those treated with
standard PVI
PROTECT-AF: Watchman LAA closure device reduces the risk of
ischemic stroke in patients with AF, entirely without anticoagulation
PACES/HRS consensus statement on WPW: Consensus statement helps clarify which young people should undergo catheter
ablation
POSTERS: New research was highlighted at HRS's Poster Town
MagnaSafe Registry: Findings show that MRI with pacers and ICDs are safe, with a few minor issues
STARTER: "Sweet spot" for echo-guided CRT lead placement explored in trial
Douglas P. Zipes Lectureship Award: This year's recipient was Dr Dan Roden
AF ablation: Reaching first-line status
AF summit: Tools and technologies for AF ablation
3. Riata ICD lead failure
A highly promoted late-breaking trial, as well as several
abstracts, attempted to define the nature and scope of the
problem with the recalled Riata ICD leads
Details: In December 2011, the Riata line of implantable
defibrillator leads (St Jude Medical) was officially recalled
because of a high risk of failure. The conductor wires can erode
through their silicone insulation and "externalize," sometimes
causing electrical abnormalities, lead malfunction, or possibly
high-voltage shorts. At HRS 2012, the Riata failure rates and
mechanisms took center stage, as groups lined up to report
their experiences with the leads, abstract after abstract, as well
as a highly promoted late-breaking trial.
"In my mind, cables that externalize, which people have called a cosmetic problem, are a lead failure. It's not how the lead
was designed to function," said Dr Laurence M Epstein (Brigham and Women's Hospital, Boston). "One of the concerns I
have is that we don't fully understand the mechanism of why these leads are failing, and I think that's really important for us
to understand moving ahead."
See: Riata revelations: ICD lead failure rates, mechanisms take HRS center stage
4. RAAFT 2
Radiofrequency catheter ablation with pulmonary vein isolation is
more likely to suppress AF recurrences than standard drug
therapy
Results: Radiofrequency (RF) catheter ablation with pulmonary vein
isolation is not only safe as a first-line treatment for paroxysmal or
persistent atrial fibrillation (AF), it's more likely to suppress AF
recurrences than is standard antiarrhythmic drug (AAD) therapy,
suggests a randomized trial with a two-year follow-up, one of the
longest for an AF-ablation trial. A single ablation procedure reduced the
risk of AF recurrence by a significant 44% compared with AAD.
Importantly, in the second Radiofrequency Ablation vs
Antiarrhythmic Drugs as First-Line Therapy of Atrial Fibrillation
(RAAFT 2) trial, which followed all patients with transtelephonic
monitoring (TTM), RF ablation's significant advantage over AAD was in
reducing bouts of AF that were either symptomatic or asymptomatic.
"So to be able to claim victory with ablation, you really need to monitor these patients very judiciously," said RAAFT 2 coâprincipal
investigator Dr Carlos Morillo (Hamilton Health Sciences-McMaster University, ON). Ablation also significantly cut the frequency of
solely symptomatic AF, he said. "These findings support the indication of radiofrequency pulmonary vein isolation as first-line therapy in
patients with paroxysmal atrial fibrillation."
See: RAAFT 2: Catheter ablation can be first line of defense against paroxysmal AF
6. FIRM ablation
Patients who have undergone focal impulse and rotor modulation
(FIRM) ablation in addition to standard pulmonary vein isolation
(PVI) remain AF free more often than those treated with standard
PVI
Results: Dr Sanjiv Narayan (University of California, San Diego VA
Medical Center) presented a technique called FIRM ablation. This
technique involves placing commercially available multipole basket
catheters into the atria. During AF, the signals are sent to an
investigational computer system, which then displays optical images
and movies of the activation. Distinct geographic "areas of interest" in
either the right or left atrium can be seen in almost all cases of AF.
Sometimes the rotors are located in areas typically targeted during
pulmonary vein isolation (PVI), but in many cases they are not. Most
remarkably, his prior work has shown that when these areas are
ablated, AF terminates. Patients who have undergone focal impulse and
rotor modulation (FIRM) ablation in addition to standard PVI remain AF
free more often than those treated with standard PVI.
Dr Narayan presented new data on the acute termination of AF with FIRM-guided ablation. In a cohort of patients with advanced AF,
he showed that rotors or focal impulses could be seen in 98%. Ablation at these focal sites terminated, slowed, or converted AF to
flutter in 88% of patients. Almost half converted to sinus rhythm. In one case, ablation for only one minute converted the patient to
sinus rhythm.
See: Turning the AF ablation world upside downâFIRM ablation
7. PROTECT-AF
Watchman LAA closure device reduces the risk of ischemic stroke in
patients with AF, entirely without anticoagulation
Results: The Watchman left atrial appendage (LAA) closure device cuts the
risk of ischemic stroke in patients with atrial fibrillation (AF), entirely without
oral anticoagulation, suggests the observational ASA-Plavix (ASAP)
Registry. These results add to what had been observed in the Watchman's
main randomized trial, Embolic Protection in Patients with Atrial
Fibrillation (PROTECT-AF), in which patients with the device took warfarin
for at least the first six weeks.
PROTECT-AF found the device noninferior to standard warfarin therapy for
protection against stroke, cardiovascular death, or systemic embolism in
patients with AF and a CHADS2 score >1. Patients getting the Watchman in
ASAP, who took clopidogrel for six months and aspirin indefinitely but
without ever going on warfarin, still showed only a 1.7% rate of ischemic
strokeâcompared with 2.2% in the PROTECT-AF Watchman group, 7.3% in
historical controls with ASAP-comparable CHADS2 scores taking aspirin
alone, and 5.0% in such controls taking aspirin plus clopidogrel.
The findings, said Dr Vivek Y Reddy (Mount Sinai School of Medicine, New York, NY) when presenting the analysis, cast doubt on the
need for even temporary warfarin in patients implanted with the Watchman. Most strokes related to thrombus forming at the device would
occur in the first six months after Watchman implantation, Reddy speculated; so if anything, eliminating the early warfarin might raise the
stroke risk, not lower it. Given the low stroke rate seen in the ASAP registry, Reddy said, "It's not clear how important that 45 days of
warfarin is. In fact, it's not clear that six months of [clopidogrel] helped at all."
See: Without warfarin, Watchman still prevents strokes, says registry
8. PACES/HRS consensus statement on WPW
Consensus statement helps clarify which young people should undergo
catheter ablation
Results: A "first-of-its-kind" consensus statement on the management of
asymptomatic patients with Wolff-Parkinson-White (WPW) syndrome should help
clarify which young people should undergo catheter ablation. The guidance is
explicitly directed at physicians treating young patients with WPW and defines
young people as between eight and 21. At the crux of the document is the
question of just when physicians should interveneâand when they shouldn'tâin
young people found, on ECGs, to have the signature electrocardiographic WPW
pattern. These are increasingly important questions, given increased emphasis
on preparticipation screening for sports in young people.
The expert consensus statement, a joint effort of the Pediatric and Congenital
Electrophysiology Society (PACES) and the HRS, estimates that from one to
three young people per 1000 likely have WPW, although manyâaround 65%â
are asymptomatic.
"While it is a small chance that an asymptomatic young person could end up having a life-threatening heart event, the number is not zero,"
said lead author on the statement, Dr Mitchell I Cohen (Phoenix Children's Hospital, AZ). "Yet, catheter ablation for every child who has
ever had a WPW pattern is also not the answer."
See: Joint PACES/HRS expert consensus statement offers guidance in the treatment of asymptomatic young patients with WPW
See: New guidance for young people with Wolff-Parkinson-White (WPW) syndrome
9. Poster Town
New research highlighted
An overwhelming number of posters were presented at the
Poster Town in the HRS 2012 Exhibit Hall. Poster sessions were
available to attendees throughout the conference, as well as
moderated poster sessions and interactive abstract poster
sessions.
Noteworthy topics included: Placing the ECG leads in the right
place to avoid false diagnoses; PVC morphology and duration
may predict the presence of cardiomyopathy; AF ablation may
not yield good results for patients with sleep apnea and
metabolic syndrome; LAA isolation is a good thing because
patients showed a higher three-year success rate; and a single
case of atrial-esophageal fistula presented following standard
cryoballoon ablation.
See: HRS 2012 poster highlights: ECGs, PVCs, OSA,
Debates in AF ablation, and the dangers of cryoablation
10. MagnaSafe Registry
Findings show that MRI with pacers and ICDs are safe, with
a few minor issues
Results: Interim findings from the MagnaSafe Registry show
there were no important safety issues but some alterations in
programming and transient impedance changes during
nonthoracic magnetic resonance imaging (MRI) in patients with
pacemakers and implantable cardioverter defibrillators (ICDs).
No instances of imaging-associated death, device failure,
generator or lead replacement, loss of capture, or electrical reset
occurred with MRI, which was performed consistently at 1.5 T. Of
less apparent significance, the battery-voltage changes seen in
12% of ICDs and device parameter changes seen in a tenth of
pacemaker and a third of ICD patients.
"We can't say whether any of those changes were clinically significant in any way," said Dr Debra Doud (Scripps Clinic, La Jolla, CA).
But whether or not there are advantages to such devices, "there still will be a large number of patients with non-MRI-conditional devices
who need to undergo an MR scan for one reason or another. And certainly [going ahead with the scan] is much safer than lead
extraction and putting in an MR-conditional device for patients who already have a device. The one population of [device] patients we
had to exclude was those with ICDs who were pacemaker-dependent," because devices from some manufacturers don't allow ICD
functions to be disabled without turning off the pacing functions.
See: MRI with pacers, ICDs: Safe, a few minor issues, says MagnaSafe registry
11. STARTER
"Sweet spot" for echo-guided CRT lead placement explored
in trial
Results: Patients are more likely to respond to cardiac
resynchronization therapy (CRT), clinically and in terms of
reverse remodeling, if speckle-tracking echocardiography guides
the placement of their pacing leads. For echo guidance in the
trial, called Speckle Tracking Assisted Resynchronization
Therapy for Electrode Region (STARTER), leads were
positioned at or close to the myocardial site of latest mechanical
activation for each patient individually. Those whose lead
positions were tailored that way, compared with standardized
positioning without echo guidance, benefited with significantly
improved ventricular end-systolic volumes and survival without
heart-failure hospitalization.
"A substantial proportion of patients, about one-third, do not respond to CRT therapy, and we don't know who those people
are," said Dr Samir Saba (University of Pittsburgh, PA). "Now we are starting to understand better. Once we know where the
leads should be appropriately placed, for that specific patient, we achieve better results."
See: "Sweet spot" for echo-guided CRT lead placement explored in trial
12. Douglas P Zipes Lectureship Award: Dr Dan Roden
Results: The lectureship award named for Douglas P
Zipes recognizes an individual who has contributed to
the advancement of cardiac electrophysiology in the
area of basic science. This year's award recipient was
Dr Dan M. Roden (Vanderbilt University School of
Medicine, Nashville, TN), who gave the lecture "Heart
to heart: Treating arrhythmias using personalized
medicine." The award was presented as part of the
Basic/Translational Science Forum on Wednesday,
May 9th, 2012 at 3pm.
See: Heart Rhythm 2012 Program eBook p.27
Roden's research lauded by Heart Rhythm
Society
13. AF ablation: Reaching first-line status
Results: For the past few years, the evidence base supports the
role of catheter ablation in AF patients who have done poorly
with medicines. But has catheter ablation progressed enough to
offer it as a first-line therapy? The North American expert task
force guidelines call for trying an antiarrhythmic drug before
ablation; the more lenient European guidelines allow us to offer
catheter ablation as first-line therapy. Which is the best
approach?
An important multicenter study, RAAFT 2, supports the notion
that AF ablation (pulmonary vein isolation [PVI])âas a first-line
therapyâhas made the transition to the front line. The RAAFT
2 trial demonstrated that low-risk symptomatic patients with AF
(87% paroxysmal) treated with standard catheter-based PVI
had less AF and fewer complications than did those treated with
AF drugs. Adverse events occurred in 7.7% of patients who had
ablation compared with 19.7% of those treated with medicine.
Although preliminary, this study will have a significant impact. The results of RAAFT 2 add more information to an already-
complex decision-making process. Until Dr Narayan's FIRM ablation becomes mainstream, AF ablation remains a daunting
challenge. Always important is the doctor-patient relationship, but never more so in cases when life-threatening therapies are
used for nonâlife-threatening diseases.
See: Has ablation reached first-line status?
14. AF Summit: Tools and technologies for AF ablation
Results: "The AF summit: Tool and technologies for
AF ablation" was a state-of-the-art update concerning
the tools and technologies that are available for use in
the field of AF ablation. Operators learned about
which tools to use and how to use them to achieve
maximum success. The topics included the
importance of PV isolation and the limitations of
current technologies in achieving permanent PV
isolation; contact force in lesion creation and the
available knowledge as to whether newly available
force-sensing catheters improve outcomes; and the
current and future role of remote navigation
technologies in AF ablation.
See: AF summit: Tools and technologies for AF
ablation
15. For more information
Complete HRS 2012 coverage on
theheart.org
HRS 2012 Scientific Sessions
16. Credits and disclosures
Journalist:
Steve Stiles, theheart.org
Fremont, CA
Disclosure: Steve Stiles has no relevant financial relationships to
disclose.
Blogger:
Dr John Mandrola
Louisville, KY
Disclosure: John Mandrola has no relevant financial relationships to
disclose.
Editor:
Shelley Wood
Managing Editor, heartwire
theheart.org
Kelowna, BC
Disclosure: Shelley Wood has disclosed no relevant financial
relationships.
Contributors:
Steven Rourke
Manager, Editorial programming theheart.org
Montreal, QC
Disclosure: Steven Rourke has disclosed no relevant financial relationships.
Katherin Vasilopoulos
Montreal, QC
Disclosure: Katherin Vasilopoulos has no relevant financial relationships to disclose.
17. More slideshows
ACC 2012 research highlights
AHA 2011 research highlights
TCT 2011 research highlights
ESC 2011 research highlights
EuroPCR 2011 research highlights
HRS 2011 research highlights
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