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Safety and feasibility of leadless pacemaker in
patients undergoing atrioventricular node ablation for
atrial fibrillation
Bharath Yarlagadda, MD,*Mohit K. Turagam, MD,
†
Tawseef Dar, MD,*
Pragna Janagam, MBBS,*Vaishnavi Veerapaneni, MBBS,*Donita Atkins, BS,*
Sudharani Bommana, MPhil,*Paul Friedman, MD, FHRS,
‡
Abhishek J. Deshmukh, MD, FHRS,
‡
Rahul Doshi, MD, FHRS,
x
Vivek Y. Reddy, MD, FHRS,
†
Srinivas R. Dukkipati, MD, FHRS,
†
Andrea Natale, MD, FHRS,
k
Dhanunjaya Lakkireddy, MD, FACC, FHRS
{
From the *Cardiovascular Research Institute, University of Kansas Medical Center, Kansas City, Kansas,
†
Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York,
‡
Division of Electrophysiology, Mayo Clinic, Rochester, Minnesota,
x
Division of Electrophysiology,
Keck School of Medicine, USC, Los Angeles, California,
k
St. David’s HealthCare, Texas Cardiac
Arrhythmia Institute, Austin, Texas, and
{
The Kansas City Heart Rhythm Institute (KCHRI) and Research
Foundation, Overland Park Regional Medical Center, HCA MidWest, Overland Park, Kansas.
BACKGROUND Atrioventricular node (AVN) ablation and perma-
nent pacing is an established strategy for rate control in the
management of symptomatic atrial fibrillation (AF). Leadless pace-
makers (LPs) can overcome some of the short-term and long-term
limitations of conventional transvenous pacemakers (CTPs).
OBJECTIVES The purpose of this study was to compare the feasi-
bility and safety of LP with those of single-chamber CTP in patients
with AF undergoing AVN ablation.
METHODS We conducted a multicenter observational study of pa-
tients undergoing AVN ablation and pacemaker implantation (LP
vs single-chamber CTP) between February 1, 2014 and November
15, 2016. The primary efficacy end points were acceptable sensing
(R wave amplitude 5.0 mV) and pacing thresholds (2.0 V at 0.4
ms) at follow-up. Safety end points included device-related major
and minor (early ,1 month, late .1 month) adverse events.
RESULTS A total of 127 patients with LP (n 560) and CTP (n 5
67) were studied. The median follow-up was 12 months (interquar-
tile range 12–18 months). Ninety-five percent of the LP group and
97% of the CTP group met the primary efficacy end point at follow-
up (57 of 60 vs 65 of 67; P5.66). There was 1 major adverse event
(loss of pacing and sensing) in the LP group and 2 (lead dislodge-
ment) in the CTP group (1 of 60 vs 2 of 67; P51.00). There were 6
minor adverse events (5 early and 1 late) in the LP group and 3
(early) in the CTP group (6 of 60 vs 3 of 67; P5.30).
CONCLUSION Our results demonstrate the feasibility and safety of
LP compared with CTP in patients undergoing AVN ablation for AF.
KEYWORDS Atrial fibrillation; AV node ablation; Leadless pace-
makers; Nanostim; Transvenous pacemaker
(Heart Rhythm 2018;15:994–1000) ©2018 Heart Rhythm Society.
All rights reserved.
Introduction
Atrioventricular node (AVN) ablation and permanent pacing
(ablate and pace) is an established strategy for rate control in
symptomatic atrial fibrillation (AF) refractory to catheter
ablation and medical management.
1–3
The current
American College of Cardiology/American Heart
Association/Heart Rhythm Society guidelines have a class
IIa recommendation for AVN ablation in the management
of AF.
4
Although an ablate and pace approach does not affect
survival, it alleviates symptoms, improves quality of life and
exercise tolerance.
1–3
Most patients undergoing AVN
ablation have long-standing persistent AF and receive a
single-chamber conventional transvenous pacemaker (CTP)
unless the left ventricular ejection fraction is ,50% when a
biventricular pacemaker is indicated.
5
Traditional pacemakers are associated with complica-
tion rates of up to 10%.
6
The subcutaneous pocket created
for the pulse generator is associated with pocket
Dr Reddy is a principal investigator of the LEADLESS II study, is a steering
committee member, and reports a consulting agreement with Abbott. Dr Fried-
man is a site investigator for LEADLESS II study, is a steering committee mem-
ber, and reports a consulting agreement with Abbott. Dr Lakkireddy and Dr
Doshi are site investigators of the LEADLESS II study and report consulting
agreement with Abbott. Dr Natale reports consulting agreement with Abbott.
Address reprint requests and correspondence: Dr Dhanunjaya Lakkireddy,
The Kansas City Heart Rhythm Institute (KCHRI) and Research Foundation,
Overland Park Regional Medical Center, HCA MidWest, 12200 W 106th
street, Overland Park, KS 66215. E-mail address: dlakkireddy@kchri.org.
1547-5271/$-see front matter © 2018 Heart Rhythm Society. All rights reserved. https://doi.org/10.1016/j.hrthm.2018.02.025
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hematoma, infection, and erosion, while the transvenous
leads are associated with endocarditis, dislodgement, car-
diac perforation, valvular regurgitation, and venous occlu-
sion.
7,8
Recently, leadless pacemakers (LPs) have become
increasingly popular. They are self-contained devices that
include a pulse generator, battery, and electrode in 1 de-
vice and overcome some of the shortcomings of CTPs.
9
LPs use a catheter-based delivery system and are directly
implanted into the right ventricle, potentially minimizing
the complications that are associated with CTPs.
10
Currently there are 2 self-contained LPs that have been
investigated for single-chamber right ventricular pacing:
Nanostim LP (Abbott, formerly St. Jude, Lake Bluff, IL)
and Micra Transcatheter Pacing System (Medtronic, Min-
neapolis, MN). LPs have been proven to be safe and effec-
tive in single-chamber pacing in the initial feasibility
clinical trials.
10,11
However, the Nanostim LP is
currently out of the market because of a manufacturer-
issued battery advisory for premature battery depletion
and a detached docking button more recently.
With the advent of LP, patients undergoing AVN ablation
and pacemaker implantation can theoretically minimize com-
plications related to CTP. We performed an observational
study, comparing the safety and efficacy of the Nanostim
LP, before the battery advisory, with those of the single-
chamber CTP in patients with AF undergoing AVN ablation
during short-term follow-up.
Methods
Study group
This is a multicenter observational study including 127 patients
(LP [n 560] and single-chamber CTP [n 567]) who under-
went AVN ablation and permanent pacemaker implantation.
Patients who received an LP as part of the LEADLESS II clin-
ical trial (ClinicalTrials.gov identifier NCT02030418), which
was a prospective international multicenter study that consisted
of 56 centers in the United States, Canada, and Australia be-
tween February 1, 2014 and November 15, 2016, were
included. This was compared with patients who underwent
AVN ablation and received a single-chamber CTP during the
same time periods. The study was approved by the institutional
review board at each institution. Baseline characteristics, pro-
cedure reports, imaging, device interrogation, and adverse
events were extracted in both groups.
Indications for AVN ablation included symptomatic AF
refractory to medications and catheter ablation. Patients
were excluded if younger than 18 years and had preexisting
CTP, implantable cardioverter-defibrillator, subcutaneous
implantable cardioverter-defibrillator, cardiac resynchroniza-
tion therapy device, another implantable LP, implanted vena
cava filter, pacemaker syndrome with retrograde ventriculoa-
trial conduction, mechanical tricuspid valve prosthesis, pul-
monary arterial hypertension, and thrombosis in one of the
veins used to gain access during the procedure. Patients
requiring dual-chamber pacing and right-sided CTP were
also excluded from the study.
Follow-up
Patients were followed up in 2 weeks, 6 weeks, and every 3
months thereafter. A complete device interrogation was per-
formed at each of the follow-up appointments. Patients
whose devices had remote monitoring capabilities were
remotely monitored.
Clinical outcomes
The primary efficacy end point included acceptable sensing (R
wave amplitude 5.0 mV) and pacing thresholds (2.0 V at
0.4 ms) at follow-up. The primary safety end points are device-
or procedure-related major and minor adverse events at
follow-up. Major adverse events included procedure-related
death, device/lead dislodgement, and other complications
prompting immediate intervention such as pericardial effusion,
cardiac perforation, large pneumothorax/hemothorax, pocket
hematoma, device malfunction, diaphragmatic/phrenic stimu-
lation, elevated pacing thresholds at implantation (.2.5 V at
0.4 ms) or between follow-up visits (an increase of 1.5 V
at 0.4 ms), major bleeding, and other vascular complications.
All device complications were adjudicated.
Complications not requiring immediate intervention
were classified as minor adverse events. Minor adverse
events were further classified as early (1 month) and
late (.1 month). Device malfunction not requiring immedi-
ate intervention (that could be managed by device reprog-
ramming) was classified under minor adverse events.
Immediate intervention was any procedure performed
within 48 hours.
LP implantation
The LP was implanted before AVN ablation in all patients.
Implantation of the Nanostim LP has been described in detail
elsewhere.
10
Briefly, after placing an 18-F sheath through the
right femoral vein, the delivery catheter with the LP was
directed into the right ventricle under fluoroscopic guidance.
Once positioned near the apex of the right ventricle, the
retractable sleeve is withdrawn, exposing the fixation helix.
The device is then screwed into the endocardium, and the de-
livery catheter is undocked from the pacemaker. A tethered
connection remains to permit device measurements and assess
the stability without the catheter. If the position and the pace-
maker parameters are optimal on the basis of fluoroscopic im-
aging and device parameters of sensing (R wave amplitude
5.0 mV) and pacing threshold (2.0 V at 0.4 ms), the tether
is removed. The device was programmed at VVI at 40–50
beats/min in all patients before AVN ablation.
Transvenous single-chamber pacemaker
implantation
All patients underwent single-chamber CTP implantation
before AVN ablation. After obtaining vascular access via
the left cephalic, axillary, or subclavian vein, a pacemaker
lead was advanced into the heart under fluoroscopic guid-
ance. Cephalic vein cutdown was the preferred approach,
while axillary and subclavian veins were used when unable
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to access the cephalic vein. The right ventricular lead was
then fixed to the apex or interventricular septum on the basis
of physician discretion. The lead was then connected to the
single-chamber pacemaker pulse generator, which was pro-
grammed to VVI at 40–50 beats/min. Appropriate device pa-
rameters during implantation included pacing (2.0 V at
0.4 ms), sensing (R wave amplitude 5.0 mV), and imped-
ance (,1200 U). Figure 1 shows chest radiographs with
CTP and LP.
AVN ablation
Standard techniques used for AVN ablation has been previ-
ously described.
12,13
Because of the relative novelty and
the uncertainty of device stability, all patients with LP
underwent AVN ablation a minimum of 2 weeks after
device implantation whereas all patients who received a
conventional single-chamber pacemaker underwent AVN
ablation at the same time as the pacemaker implantation.
The safety of simultaneous AVN ablation with pacemaker
implantation for conventional pacemakers has been well
established.
14
An irrigated ablation catheter was introduced
via the femoral vein access into the right atrium under fluoro-
scopic guidance. The position of the AVN was identified
using fluoroscopy and electrograms, and radiofrequency
ablation was performed. All pacemakers were programmed
VVIR at 80 beats/min immediately after ablation for a dura-
tion of 4 weeks and subsequently reset to VVIR at 60–70
beats/min.
Statistical analysis
Continuous variables are expressed as mean 6SD if vari-
ables are normally distributed and median (interquartile
range [IQR]) when deviations from normality were present.
Categorical variables are expressed as counts and percent-
ages. Categorical variables were compared between the
groups using the c
2
or Fisher exact test. Continuous variables
were compared using the independent samples ttest. A
2-tailed Pvalue of .05 was considered statistically
significant. Statistical analysis was performed using SPSS
version 23.0 (IBM Corp, Armonk, NY).
Results
Patient characteristics
The mean age of the entire cohort was 74 69 years. There
was a significantly higher proportion of men in the LP group
than in the CTP group (48% vs 24%; P5.005). There was no
significant difference in age, comorbid conditions, or medi-
cations between the 2 groups (Table 1). The median
follow-up was 12 months (IQR 12–18 months).
Figure 1 Chest radiographs with (A) conventional transvenous pacemaker and (B) leadless pacemaker (red arrow).
Table 1 Comparison between demographic variables, comorbid
conditions, and medications between the groups
Characteristic
Leadless
pacemaker
(n 560)
Conventional
pacemaker
(n 567) P
Demographic characteristics
Age (y) 74 68.7 74 69.6 .804
Sex: male 29 (48) 16 (24) .005
Comorbidities
Diabetes 15 (25) 12 (18) .390
Hypertension 51 (85) 57 (85) 1.000
Hyperlipidemia 43 (72) 40 (60) .192
Congestive heart failure 12 (25) 21 (31) .161
Left ventricular
ejection fraction (%)
57 68.8 53 612.8 .155
Coronary artery
bypass surgery
9 (15) 6 (8) .418
Percutaneous
coronary intervention
9 (15) 9 (14.5) 1.000
Medications
Antiarrhythmics 13 (22) 10 (16) .489
Anticoagulants 51 (85) 58 (87) .805
Antiplatelets 21 (35) 28 (42) .469
ACE inhibitors/ARBs 21 (35) 22 (34) 1.000
b-Blockers 40 (67) 46 (69) .850
Values are presented as mean 6SD or as n (%). Statistically significant
differences are presented in boldface.
ACE 5angiotensin-converting enzyme; ARB 5angiotensin receptor
blocker.
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Primary efficacy end points
Ninety-five percent of the LP group and 97% of the CTP group
met the primary efficacy end point of stable device performance
on follow-up (57 of 60 vs 65 of 67; P5.66). Two of the 3 pa-
tients in the LP group developed increasing capture thresholds:
1 underwent LP retrieval and upgrade to a dual-chamber device
as rhythm control with an antiarrhythmic drug was attempted,
and the other was monitored closely. One patient developed
loss of pacing and telemetry at 1 year and underwent upgrade
to a biventricular pacemaker. Both patients in the CTP group
who did not meet the efficacy end point developed acute dis-
lodgements and underwent revisions.
There was no statistically significant difference in the
mean sensing amplitude between LP and CTP cohorts
(8.9 62.48 mV vs 9.8 63.28 mV; P5.45) at 12 months
(Figure 2). Patients with single-chamber CTP had a signifi-
cantly higher mean capture threshold at 0.4 ms pulse width
(0.94 60.48 V vs 0.63 60.45 V; P5.009) and impedance
(540 6106.9 Uvs 470 694.4 U;P5.003) than did those
with LP at 12 months of follow-up (Figure 2).
Primary safety end points
Major adverse events
There were 2 major adverse events in the CTP group and 1 in
the LP group (2.9% [2 of 67] vs 1.6% [1 of 60]; P51.00)
during the study period. There were 2 acute lead dislodge-
ments in the CTP group: one patient had lead dislodgement
with no symptoms within 12 hours of the index procedure,
and the second patient had syncope secondary to lead
dislodgement at 1 week postprocedure. There was 1 major
adverse event in the LP group with loss of pacing and sensing
at 1 year from the index procedure, requiring an upgrade to a
biventricular pacemaker. There were no long-term major
adverse events in the CTP group (Figure 3). Table 2 shows
a comparison of safety and efficacy end points between the
groups.
Mortality
There were no device- or procedure-related deaths in the
study population. There was 1 (1.6%) cardiac death reported
in the LP cohort. The cause of death was attributed to wors-
ening heart failure and multiple comorbidities including
advanced age, severe tricuspid and mitral regurgitation, and
aortic valve replacement complicated by hemispheric stroke.
In light of advanced heart failure, the patient was transitioned
to comfort care and died subsequently.
There was 1 cardiac death (1.4%) in the CTP group during
the study period. The cause of death was progressive right
heart failure from pulmonary hypertension secondary to
systemic sclerosis.
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
Implant 2 weeks 3 months 6 months 12 months
Voltage in mv
Follow up
Capture threshold at follow up
Leadless
Single chamber
P0.009
0
2
4
6
8
10
12
14
Implant 2 weeks 3 months 6 months 12 months
Voltage in mv
Follow up
R wave amplitude at follow up
Leadless
Single chambe
r
P 0.446
0
100
200
300
400
500
600
700
Implant 2 weeks 3 months 6 months 12 months
Impedance in Ohms
Follow up
Impedance at follow up
Leadless
Single chamber
P 0.003
AB
C
Figure 2 Comparison of device performance (ie, pacemaker parameters) between the groups at a median follow-up of 12 months: (A) capture threshold, (B)
R-wave amplitude, and (C) impedance. Pvalues are mentioned in the inset for each comparison.
Major Early <1m Late >1m
Leadless 151
Single chamber 230
0
1
2
3
4
5
6
No of adverse events
Minor
Adverse events
Leadless Single chamber
P 1.000
P 0.474
P 0.472
Figure 3 Bar diagram comparing the major and minor (early ,1 month
and late .1 month) adverse events between the groups. Pvalues are
mentioned in the inset for each comparison.
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Minor adverse events
There were 6 (10%) minor adverse events in the LP group
and 3 (4.4%) in the CTP group (P5.305) during the study
period (Table 3).
There were 5 early and 1 late adverse events in the LP
group. Early adverse events included access-related com-
plications including groin hematoma (n 51), pseudoa-
neurysm (n 51), pericardial effusion (n 51) not
requiring intervention, and increasing pacing threshold
(n 52) requiring nonemergent device upgrade. Late
adverse events included pseudoaneurysm (n 51). All
access-related complications in the LP cohort occurred at
the time of LP implantation.
There were 3 early minor adverse events in the CTP
group. Early adverse events included access-related compli-
cations including pseudoaneurysm and arteriovenous fistula
(n 51), groin hematoma (n 51), and pocket hematoma
(n 51). Figure 4 shows Kaplan-Meier estimate of freedom
from serious adverse events in both cohorts.
Discussion
Main findings
Our study is the first study reporting on the feasibility of LPs
in patients with AF undergoing AVN ablation. Our results
demonstrate that LPs have similar safety and efficacy as
single-chamber CTPs during short-term follow-up. Ninety-
five percent of the LP group and 97% of the CTP group
met the primary efficacy end point of stable device perfor-
mance at a median follow-up of 12 months (IQR 12–18
months). Mean capture threshold and impedance were signif-
icantly higher in the single-chamber transvenous group at
follow-up; however, this was not clinically relevant. Overall,
adverse events were low in both groups. There were no sta-
tistically significant differences in the major or minor adverse
events between the 2 groups during the study period.
LPs have come a long way since their inception. Earlier
multicomponent leadless systems were associated with
significant complications.
15
Newer self-contained systems
include the pulse generator, battery, and electrode in 1 device
and have overcome some of the complications of conven-
tional pacemakers. The LEADLESS II clinical trial, which
studied the safety of the Nanostim LP, showed
complication-free survival in 94% of the patients at 90
days.
10
In the subsequent LEADLESS II trial, device-
related complications occurred in 7% of the patients and
included device dislodgements in 1.7%, elevated pacing
thresholds requiring device repositioning in 1.3%, and car-
diac perforation in 1.3%.
9
When the cumulative results of
the LP studies were compared with those of the historical
single-chamber pacemaker cohorts, LPs were found to be
associated with a slightly higher (4.8% vs 4.0%) short-term
complication rate.
16
This was thought to be secondary to
the operator learning curve associated with LP implantation
and underreporting of complications in the conventional
pacemaker studies owing to lack of careful site level
follow-up.
LPs had their shortcomings in recent times. In October
2016, the manufacturer issued a battery advisory for Nano-
stim LP devices. They reported pacemaker failures with
loss of communication and pacing secondary to premature
battery depletion. At the time of the advisory, 7 of the 1423
Table 3 Comparison of various adverse events between the 2
groups
Adverse event
Leadless
pacemaker
(n 560)
Conventional
pacemaker
(n 567) P
Device malfunction requiring
emergent intervention
Loss of telemetry and pacing 1 0 .47
Lead/device dislodgement 0 2 .49
Hematoma/bleeding
Pocket hematoma 0 1 1.00
Vascular access–related
complication
Pseudoaneurysm 2 1 .60
Groin hematoma 1 1 1.00
Pericardial effusion not
requiring intervention
1 0 .47
Device malfunction requiring
nonemergent intervention
Increasing right ventricular
pacing threshold
2 0 .22
Table 2 Comparison of efficacy and safety end points between the groups at follow-up
Characteristic
Leadless pacemaker
(n 560)
Conventional pacemaker
(n 567) P
Primary efficacy end points at a median follow-up of 12 mo
Stable device performance (capture threshold 2.0 V at
0.4 ms, R-wave sensing amplitude 5.0 mV)
57 (95) 65 (97) .66
Primary safety end points at a median follow-up of 12 mo
Major adverse events
Device/lead malfunction requiring immediate intervention 1 (1.6) 2 (2.9) 1.00
Minor adverse events
Device malfunction requiring nonemergent intervention 2 (3.3) 0 (0) .22
Device pocket complications 0 (0) 1 (1.4) 1.00
Vascular access complications 3 (5) 2 (2.9) .66
Pericardial effusion not requiring intervention 1 (1.6) 0 (0) .47
Values are presented as n (%).
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devices (0.5%) were affected. Symptomatic bradycardia was
reported in 1 patient, while the remaining 6 were asymptom-
atic. This was an unanticipated complication of the Nanostim
LP, and it underlines the fact that electronic devices are prone
to failures and their durability should be assessed over a long
period of time. However, the medical community believes in
the significant promise offered by the LPs in abating some of
the major complications caused by CTP and investigations
into the short-term and long-term durability should continue.
All patients included in the study had successful AVN
ablation and device implantation. Most patients in both
groups met the primary efficacy end point of stable device
performance at a median follow-up of 12 months (95% in
the LP group vs 97% in the CTP group; P5.66).
Both groups had similar safety profiles during the study
period. There was 1 major adverse event (loss of pacing
and sensing) in the LP group and 2 (lead dislodgement) in
the CTP group (2 of 60 vs 1 of 67; P51.00). Even though
minor adverse event rates were slightly higher in the study
group, there was no statistically significant difference in
major or minor adverse events between the groups. After
the battery advisory, the manufacturer recommended device
replacement in all pacemaker-dependent patients. Of the 60
patients with LP in our study, none had any serious adverse
events due to premature battery depletion. Thirty patients un-
derwent elective device replacement and the rest were moni-
tored closely, despite being pacemaker dependent, without
any significant adverse events to date.
Unfortunately, the battery advisory did not allow for long-
term event analysis in our study. One would expect LPs to be
an attractive option compared with CTPs when complica-
tions related to the device pocket or lead malfunction might
ensue. Moreover, device- or procedure-specific complica-
tions such as tricuspid regurgitation and hemothorax are
less likely to develop in the LP group. Further large random-
ized controlled trials are needed to validate our short-term
findings and study the long-term safety and efficacy of LPs
in comparison with CTPs.
Study limitations
Our main limitations are the observational nature of the
study, small study population, and relatively low event rates.
Moreover, long-term follow-up information was not avail-
able for the study group because of the battery advisory
and outcomes could not be compared. Despite these limita-
tions, this is the first proof-of-concept study that demon-
strates comparable safety and efficacy of leadless pacing in
patients with AF undergoing AVN ablation.
Conclusion
The results of our study demonstrate comparable safety and
efficacy of LPs compared with traditional single-chamber
transvenous pacemakers in patients with AF undergoing
AVN ablation during short-term follow-up.
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Yarlagadda et al Leadless Pacemaker After Atrioventricular Node Ablation 999
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