Transcript New Findings in the Management of AF in

New Findings in
the Management of AF
in Pacemaker Patients
Results from the MINERVA Trial
a Medtronic sponsored trial
February 2014
Steven Zweibel, MD,
FACC, FHRS, CCDS
Director of Electrophysiology
Hartford Hospital
Hartford, CT
2013 Late-Breaking Clinical
Trial Abstracts
Circulation. 2013;128:2704-2722
World Wide Web at:
http://circ.ahajournals.org/content/128/24/2704
Study Aim and Design
Aim: to evaluate whether
DDDRP + MVP or MVP reduces
mortality, morbidity, or progression
to permanent AF compared with
standard dual chamber pacing.
Multicenter (63 centers), international,
randomized, single blind study with 3 arms
enrolling 1,166 patients with:
• Class I or class II indications
for dual chamber pacing
• Previous atrial
tachyarrhythmias
• No history of
permanent AF or third
degree AV block
Primary Objective
Compare the Control DDDR to DDDRP +
MVP arms at 2 years using the
composite clinical endpoint of:
• All-cause death
• CV hospitalizations
• Permanent AF
Patient Baseline Characteristics
STAT
Control DDDR
(385 patients)
DDDRP + MVP
MVP
(383 patients)
(398 patients)
%
53
45*
53
Mean (std)
73 (9)
74 (9)
74 (9)
History of syncope
%
26
26
29
CMP
%
11
11
16
Ischemic
%
26
23
25
MI
%
16
12
14
Hypertension
%
70
73
74
HF
%
9
9
8
Mean (std)
56 (9)
57 (10)
56 (10)
TIA or Stroke
%
11
10
9
Diabetes
%
19
15
16
Renal disease
%
6
6
6
COPD
%
8
9
8
AF (vs. AT/AFL)
%
87
83
89
Median (IQ-IIIQ)
187 (160-205)
186 (158-200)
192 (160-210)
Implant indication
SND
I or II degree AV block
Other
%
%
%
83
7
10
82
8
10
84
6
10
Medication
Anticoagulants
AAD class I or III
Beta-blockers
%
%
%
45
45
34
44
43
29
44
44
35
PARAMETER
Gender (Male)
Age
EF (%)
PR (ms)
* p < 0.05 DDDRP + MVP vs. the other two groups
Primary Outcome
(All-Cause Death, CV Hospitalizations, or Permanent AF)
Intention-to-treat survival analysis using time to first event
All-Cause Death
Intention-to-treat survival analysis using time to first event
CV Hospitalizations
Intention-to-treat survival analysis using time to first event
Permanent AF
Intention-to-treat survival analysis using time to first event
Permanent AF
Intention-to-treat survival analysis using time to first event
• Cardioversion for atrial arrhythmias occurred less
frequently in the DDDRP + MVP vs. Control DDDR
(49% relative reduction, p = 0.001)
• AF-related hospitalizations and ER visits occurred less
frequently in the DDDRP + MVP vs. Control DDDR
(52% relative reduction, p < 0.0001)
Incidence of AF
Intention-to-treat survival analysis using time to first event
Potential Contribution of Reactive ATP
Risk of AF > 7 days and aATP efficacy
Note:since ATP treated only
episodes longer than 2 minutes,
to compare the different groups
in a correct and balanced way,
this analysis considered only
patients with at least 2 minutes
of AF
Not conclusive results …
Select Studies on Atrial Therapies
Trial
N of Pts
Implant
Indication
Atrial Therapies
Studied
ATTEST
Lee, et al.
368
Brady + AT/AF
Intervention + ATP
Therapies are safe
No difference in AT/AF
burden or frequency
2,580
Brady or ICD
No history of
AT/AF > 5 mins
Intervention
No benefit to
continuous atrial
overdrive pacing
1,065
Brady
No history of persistent
or permanent AF
No 2nd/3rd degree block
AV Search + MVP
Min V. pacing results in
moderate decrease in
risk of persistent AF
Intervention
3 Intervention
algorithms did not
reduce AT/AF burden
or frequency
JACC. Nov 11, 2003
ASSERT
Healy, et al.
NEJM. Jan 12, 2012
SAVEPACe
Sweeney, et al.
NEJM. Sep 6, 2007
ASPECT
Padeletti, et al.
JCE. Nov 2003
298
Brady + AT/AF
Results
Evolution of Atrial ATP
First Generation
Treated atrial arrhythmias as if they were ventricular arrhythmias
All therapies exhausted within 10 minutes
100 ms
350 ms
Atrial Therapy Zone
8 hours
220 ms
320 ms
•
AT/AF detected
•
•
All therapies
delivered in 10 minutes
Rhythm
changed
•
No ATP
available to
potentially
terminate
•
ATP unsuccessful
Evolution of Atrial ATP
Second Generation
Reactive ATP
100 ms
150 ms
200 ms
250 ms
300 ms
350 ms
Atrial Therapy Zone
8 hours
320 ms
220 ms
•
AT/AF detected
•
•
All therapies
delivered
Rhythm
changed
•
ATP Therapy
available for
possible
termination
•
ATP Unsuccessful
Example of Legacy ATP
Successful Ramp Following the
Rhythm Transition (11 hour episode)
Successful
termination
Ramp ATP
delivered
Example of Reactive ATP in a
MINERVA Patient
Discussion Recap
• The MINERVA study demonstrates the potential
ability of atrial pacing interventions and reactive ATP
to slow the progression to permanent AF
• Reactive ATP was a key therapy component affecting
the reduction in time to permanent AF
• Reactive ATP opportunistically treats episodes of AF
when they spontaneously organize or slow down
Potential Practice Implications
• No reduction in mortality at 2 years
• No change in CV hospitalizations at 2 years
• 52% relative reduction in atrial cardioversion, 49% relative reduction
in AF hospitalization and ER visits
• AFIB begets AFIB and NSR begets NSR
– Providing an extended opportunity for AF ablation
• Reasonable to consider Reactive ATP in any patient receiving a PM
with history of AF or at risk
• Reasonable to consider Reactive ATP in ICD and/or CRT patients;
however, they have not been studied
Thank You
Brief Statement
Indications
Implantable Pulse Generators (IPGs) are indicated for rate adaptive
pacing in patients who may benefit from increased pacing rates concurrent
with increases in activity and increases in activity and/or minute ventilation.
Pacemakers are also indicated for dual chamber and atrial tracking modes in
patients who may benefit from maintenance of AV synchrony. Dual chamber
modes are specifically indicated for treatment of conduction disorders that
require restoration of both rate and AV synchrony, which include various
degrees of AV block to maintain the atrial contribution to cardiac output and
VVI intolerance (e.g. pacemaker syndrome) in the presence of persistent
sinus rhythm. For the MR Conditional IPG, a complete pacing system
consisting of either an Advisa DR MRI™ SureScan® Model A2DR01 IPG or
Revo MRI SureScan® Model RVDR01 IPG and 2 CapSure Fix MRI®
SureScan 5086MRI leads is required for use in the MR environment.
Contraindications
IPGs are contraindicated for dual chamber atrial pacing in patients with
chronic refractory atrial tachyarrhythmias; asynchronous pacing in the
presence (or likelihood) of competitive paced and intrinsic rhythms; unipolar
pacing for patients with an implanted cardioverter defibrillator because it may
cause unwanted delivery or inhibition of ICD therapy; and certain IPGs are
contraindicated for use with epicardial leads and with abdominal
implantation.
Warnings/Precautions
Changes in a patient’s disease and/or medications may alter the efficacy of
the device’s programmed parameters. Patients should avoid sources of
magnetic and electromagnetic radiation to avoid possible underdetection,
inappropriate sensing and/or therapy delivery, tissue damage, induction of
an arrhythmia, device electrical reset or device damage. Do not place
transthoracic defibrillation paddles directly over the device.
Potential complications
Potential complications include, but are not limited to, rejection phenomena,
erosion through the skin, muscle or nerve stimulation, oversensing, failure to
detect and/or terminate arrhythmia episodes, and surgical complications
such as hematoma, infection, inflammation, and thrombosis.
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Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Tel: (763) 514-4000
Fax: (763) 514-4879
See the device manual for detailed information regarding the implant
procedure, indications, contraindications, warnings, precautions, and
potential complications/adverse events. For further information, please call
Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at
www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the
order of a physician.
Medtronic USA, Inc.
Toll-free: 1 (800) 328-2518
(24-hour technical support for
physicians and medical professionals)
UC201405311 EN
February 2014
Back Up
Intervention algorithms
• Atrial rate stabilization (ARS)
• Atrial pacing preference (APP)
• Post mode switch overdrive pacing (PMOP)
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Atrial Rate Stabilization (ARS)
• Intrinsic premature beats not followed by a long
pause (“short-long”)
• Each atrial interval is measured. The next pacing
escape is this interval + a percentage
(12.5, 25 or 50%)
• The fastest pace allowed is set by the
Minimum Interval (shared by APP)
• Marker Channel paces are marked “PP” if generated
by ARS
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ARS - Atrial Rate Stabilization
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Atrial Pacing Preference (APP)
• Designed to maintain a high percentage of atrial
pacing
• On every non-refractory atrial sense, pacing
escape interval is shortened. Amount of
decrease is programmable, nominally 50ms
• After consecutive atrial paces (nominally 10), the
escape interval is lengthened by 20 ms
• APP cannot go faster than the Minimum Interval.
• Marker Channel paces are marked “PP” if
generated by APP
29
APP - Atrial Pacing Preference
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Post Mode Switch Overdrive
Atrial rate
Atrial tachyarrhythmia
Confirm sinus (about 15 beats)
paced beats
Overdrive Rate
(DDIR)
pacing rate (not slower than 70)
(DDIR)
Sinus Rhythm
pacing rate
(DDDR)
Overdrive Period
time
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