JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
9, 2023
ª 2023 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
PUBLISHED BY ELSEVIER
EDITORIAL COMMENT
The NCDR AFib Ablation Registry
Better Late Than Never?*
Matthew R. Reynolds, MD, MSC, Javaria Ahmad, MD
B eginning with a landmark case series pub-
lished in 1998, 1 over the past nearly 25 years
catheter ablation for atrial fibrillation (AF)
has grown from a treatment that followed drug fail-
ures, performed by a limited cadre of world experts,
to a commonplace procedure increasingly offered at
earlier stages of the disease process. 2 This remarkable
evolution has been facilitated by important advances
in ablation technology, carefully conducted clinical
trials, and the collective experience and shared wis-
dom of the clinical electrophysiology community.
SEE PAGE 867
Despite all the progress, knowledge about the
contemporary outcomes of AF ablation in general
practice remains surprisingly limited. In this issue of
the Journal of the American College of Cardiology, Hsu
3
et al begin to address this knowledge gap by
reporting initial findings from the first 5 years of data
collection in the National Cardiovascular Data Regis-
try (NCDR) AFib Ablation Registry. These data pro-
vide a potentially clearer yet still incomplete picture
of current AFib ablation practices and outcomes in
the United States. With this publication, many
familiar themes pertaining to the benefits and limi-
tations of registry-based research are raised.
Between 2000 and 2010, while early clinical trials
were being conducted, AF ablation was already
proliferating using the existing ablation tools of the
day. In the absence of other data sources, voluntary
worldwide surveys and small- to medium-sized case
*Editorials published in the Journal of the American College of Cardiology
reflect the views of the authors and do not necessarily represent the
views of the Journal of the American College of Cardiology or the American
College of Cardiology.
From the Division of Cardiology, Lahey Hospital & Medical Center,
Burlington, Massachusetts, USA.
The authors attest they are in compliance with human studies commit-
tees and animal welfare regulations of the authors’ institutions and Food
and Drug Administration guidelines, including patient consent where
appropriate. For more information, visit the Author Center.
ISSN 0735-1097/$36.00
VOL. 81, NO.
series and registries played an important role in
informing the field about ablation strategies, out-
comes, and safety concerns.4,5 This
information-sharing helped create informal early
type of
practice standards, later codified with the incorpora-
tion of clinical trial evidence into practice guidelines
and expert consensus documents.6
As with other procedural areas in cardiovascular
medicine, it was recognized that well-conducted
registries could supplement information from trials
on AF ablation outcomes. In fact, meetings were held
in 2009 to 2010 in an effort to organize a U.S. registry
of AF ablation with a focus on procedural safety, as all
agreed that a registry with limited follow-up would be
poorly suited for evaluating effectiveness. 7 However,
stakeholder support was insufficient to launch a reg-
istry of AFib ablation at the time, and the NCDR AFib
Ablation Registry would not begin collecting data
until 2016. In the meantime, insurance claims data-
bases served as the principal source for large-scale
outcomes research on AF ablation.8 Unfortunately,
the most easily accessible of these databases, such as
the Nationwide Inpatient Sample and the related
Nationwide Readmissions Database, are limited to
inpatient records. As AF ablation shifted to mainly
outpatient encounters, these sources failed to capture
the majority of procedures, leading to potentially
distorted findings.9
The AFib Ablation Registry has notable strengths,
including a detailed data collection form that pro-
vides far richer clinical detail than insurance claims.
The NCDR has well-established data quality processes
and randomly audits a subset of sites each year. Thus,
the data are likely to be accurate, although some
underreporting of adverse events may still be
possible. Perhaps most importantly, the registry has
the advantage of scale, by 2020 collecting >10 times
more records than any previous prospective registry
of AF ablation.4
The initial findings reported by Hsu et al3 are
mostly unsurprising. Patients undergoing AF ablation
in the United States remain disproportionately young
https://doi.org/10.1016/j.jacc.2022.12.017
880 Reynolds and Ahmad
The NCDR AFib Ablation Registry
(mean age 65 years), White (94%), male (65%), and
well insured (78% private), reflecting the disparities
seen widely in U.S. health care. A slight majority
(56%) had paroxysmal AF, 71% used ongoing or prior
antiarrhythmic drug therapy, and 21% were redo
procedures. Complete pulmonary vein isolation was
achieved in 92% of procedures, 95% in first-time
cases. Acute procedural success may thus fall
slightly short of that reported from top centers in
clinical trials but not by much. Aside from a data
element on discharge atrial rhythm (93.5% sinus), the
registry currently provides no further information on
procedural effectiveness. The limited ability of this
registry to assess procedural effectiveness was
expected. 7
Perhaps the most compelling data from the present
study pertain to complications, which were reported
to occur in only 2.5% of procedures. 3 This figure
seems low compared with prior estimates from claims
analyses, smaller registries, or the CABANA (Catheter
Ablation Versus Antiarrhythmic Drug Therapy for
Atrial Fibrillation) trial, which reported total compli-
cation rates of around 5% to 7%. 8,10,11 Direct com-
parisons across these disparate sources should be
made with caution as the included events, defini-
tions, ascertainment methods, and observational
time frames differ. For example, CABANA reported a
1.1% incidence of pericarditis, 11 an outcome not
tracked by NCDR. Nonetheless, the NCDR data sup-
port the conclusion that AFib ablation has become a
fairly safe procedure, with life-threatening or life-
altering complications now occurring <1% of the
time.
The major limitations of the AFib Ablation Registry
stem from its voluntary nature and focus on the
procedural encounter. Despite the large study sam-
ple, data were collected from only 162 hospitals, 3 less
than one-third as many as the 495 included in the
mandatory Left Atrial Appendage Occlusion Registry
by the end of 2018. 12 Hence, the AFib Ablation Reg-
istry should not be construed as a complete or
necessarily representative account of AFib ablation
outcomes for the United States as a whole. Rather,
these results 3 should be viewed as a nonrandom
sampling of outcomes from larger, better-resourced
programs willing and able to share their data. The
2.5% complication rate is therefore likely to be accu-
rate but only for those participating hospitals.
JACC VOL. 81, NO. 9, 2023
MARCH 7, 2023:879–881
Furthermore, the authors’ findings on hospital vol-
umes (median 130 ablations per hospital per year) are
likely to be substantially overestimated, as the ma-
jority of hospitals where AFib ablation is performed
did not participate.
In addition to what we do not know because of
limited hospital participation, the AFib Ablation
Registry 3 currently provides little or no information
on many items of potential interest either because
questions were not asked (eg, ablation energy source,
mapping system, specific lesion sets beyond pulmo-
nary vein isolation, intraprocedural imaging) or were
infrequently answered (eg, echocardiographic mea-
sures, quality of life). As a result, the AFib Ablation
Registry will be unable to offer any insight into some
of the key questions facing the field today, although
that is true to some degree for all observational study
designs.
What then can we conclude from this first report on
the latest national registry from NCDR?3 As of
December 2020, it had already collected more data
than any other prospective registry of AF ablation
ever attempted, thus becoming a valuable data re-
pository for investigators to mine going forward. With
the mentioned limitations in mind, acute procedural
outcomes of AF ablation at the participating hospitals
were excellent, providing solid benchmarks against
which other programs can assess their quality. Those
things said, this first paper from the AFib Ablation
Registry arrives >20 years after the field began. For
anyone closely engaged with AF ablation over this
time frame, the paper by Hsu et al3 probably does not
tell us a great deal that we did not already know. The
initial results from the AFib Ablation Registry suggest
that a tremendous amount of quality improvement
has already happened—without a national registry.
FUNDING SUPPORT AND AUTHOR DISCLOSURES
Dr Reynolds serves as a consultant to Medtronic and iRhythm. Dr
Ahmad has reported that she has no relationships relevant to the
contents of this paper to disclose.
ADDRESS FOR CORRESPONDENCE: Dr Matthew R.
Reynolds, Lahey Hospital & Medical Center, 41
Mall Road, Burlington, Massachusetts 01805 USA.
E-mail: Matthew.R.Reynolds@lahey.org. Twitter:
@DrMattReynolds.
JACC VOL. 81, NO. 9, 2023
MARCH 7, 2023:879–881
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KEY WORDS atrial fibrillation, catheter
ablation, registry