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Transcript
AICD usage for primary
prevention at Mercy Hospital:
successes, challenges and next
steps
Mohammad Tahir
PGY-3
Automatic Implantable Cardioverter
Defibrillator
• AICD: shock therapy in the event of VT/VF
• Indicated for prevention of suddent cardiac
death (SCD)
• Secondary prevention: resuscitation after
VT/VF arrest
• Primary prevention: high risk for
development of VT/VF
Background
• MADIT-I Trial1: mortality benefit in post MI,
NSVT & LVEF <35%
• MADIT-II Trail2: mortality benefit in post MI &
LVEF <30%
• ACC/AHA 20023: for LVEF <30% (class IIa)
• SCD-HeFT Trial4: mortality benefit in
ischemic & non-ischemic CM, LVEF <35%
1Moss
AJ et al. N Engl J Med 1996;335:1933-1940
2Moss AJ et al. N Engl J Med. 2002 Mar 21;346:877-83.
3ACC/AHA/NASPE 2002 Guideline Update Circulation 2002;106;2145-2161.
4Bardy GH et al. N Engl J Med 2005;352:225-237.
Adapted from: ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of
Cardiac Rhythm Abnormalities J. Am. Coll. Cardiol. 2008;51;e1-e62; May
15, 2008.
Background (contd…)
• ACC/AHA 2008: LVEF <35%
– Post MI (after 40 days), NYHA II/III (class I)
– Non-Ischemic NYHA II/III (class I)
• Cost effective: QALY, Hospitalization
ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac
Rhythm Abnormalities J. Am. Coll. Cardiol. 2008;51;e1-e62; May 15, 2008.
Objectives
• To determine the proportion of eligible
patients receiving or referred to AICD
implantation
• To analyze the factors affecting the referral
Methodology
•
•
•
•
Retrospective Chart review
IRB Approval: consent waived
Duration: Jan-July 2008
Data Abstracted on
–
–
–
–
Demographics
Duration of CHF
Ischemic/ Non-ischemic Cardiomyopathy,
History of
• coronary artery disease,
• diabetes,
• hypertension,
• chronic kidney disease,
• pacemaker implantation,
• CABG or PCI
Methodology (contd…)
– Baseline rhythm: sinus rhythm/ atrial fibrillation,
– QRS complex duration
– Use of medications including
•
•
•
•
•
beta blocker,
ACE inhibitor,
digoxin,
anti-arrhythmic drugs (amiodarone),
anti-coagulation with Coumadin,
– New York Heart Association (NYHA) class for CHF
– Pedal edema
– Acute myocardial infarction (AMI) during current
hospital admission
Inclusion criteria
• All hospital discharges with a primary or
secondary diagnosis of Heart Failure or
Cardiomyopathy
• Evidence of LVEF <35%
– Echocardiography
– Nuclear stress test
– MUGA Scan
– Left Ventriculography
Exclusion Criteria
•
•
•
•
In-hospital death
AICD previously implanted (in-situ)
Discharge to hospice services
Comfort measures only
Data Analysis
•
•
•
•
Variables abstracted in MS excel
Analysis software: SPSS & Epi Info
Chi-square test: Categorical Variables
Independent sample t-test: Continuous
variables
• Statistical significance: p <0.05.
Results
Total patients with LVEF ≤ 35%
208
In-Hospital Death
15
AICD previously implanted
35
Hospice/comfort care
13
Study Population
N=145
Referred Group
77 (53%)
Unreferred Group
68 (47%)
Referred Group
(n=77)
Out-patient evaluation for AICD
16 (21%)
Re-evaluation after
optimization of therapy
8 (10%)
Patient refusal for AICD
9 (12%)
AICD deferred in
view of risk vs. benefit
3 (4%)
AICD implanted during hospitalization
41 (53%)
Clinical Variables of ‘referred’ (n=77)
and ‘unreferred’ (n=68) groups
Referred
Group
(N=77)
Unreferred
Group
(N=68)
P-Value
69.9 ± 14.6
76.0 ± 12.0
<0.01
27 (35.1)
28 (41.2)
0.5
Non-White race n (%)
4 (5.2)
4 (1.5)
1.0
NYHA class IV, n(%)
8 (10.4)
3 (4.4)
0.29
NYHA class II / III, n (%)
69 (89.6)
65 (95.6)
0.29
Acute/ exacerbation CHF, n (%)
52 (67.5)
45 (66.1)
0.99
Demographic and clinical
Characteristics
Age in years, Mean ± SD
Sex, females, n (%)
Clinical Variables of ‘referred’ (n=77)
and ‘unreferred’ (n=68) groups
Demographic and clinical
Characteristics
Referred
Group
(N=77)
Unreferred
Group
(N=68)
P-Value
Pedal Edema present, n (%)
20 (26)
17 (25)
0.95
Diabetes, n (%)
33 (42.9)
28 (41.2)
0.97
Hypertension, n (%)
63 (81.8)
57 (83.8)
0.92
Acute Myocardial Infarction, n
(%)
11 (14.3)
13 (19.1)
0.58
H/o Coronary artery Disease,
n (%)
51 (66.2)
42 (61.8)
0.7
H/O CABG, n (%)
26 (33.8)
24 (35.3)
0.99
Clinical Variables of ‘referred’ (n=77)
and ‘unreferred’ (n=68) groups
Demographic and clinical
Characteristics
Referred
group
(N=77)
Unreferred
group
(N=68)
P-Value
H/O PCI, n (%)
6 (7.8)
7 (10.3 )
0.81
H/O Pacemaker Implantation,
n (%)
6 (7.8)
9 (13.2)
0.42
CKD stage ≥3,n (%)
20 (26 )
23 (33.8)
0.4
Beta Blocker at admission, n (%)
51 (66.2)
40 (58.8)
0.45
Beta Blocker at discharge, n (%)
66 (85.7)
56 (82.4)
0.75
Clinical Variables of ‘referred’ (n=77)
and ‘unreferred’ (n=68) groups
Demographic and clinical
Characteristics
Referred
Group
(N=77)
Unreferre
Group
(N=68)
P-Value
Digoxin use at at admission, n (%)
16 (20.8)
11 (16.2)
0.62
Coumadin Use at admission, n (%)
16 (20.8)
19 (27.9)
0.42
Anti-arrythmics use at admission, n
(%)
2 (2.6)
1 (1.5)
1.0
ACE inhibitor at discharge, n (%)
56 (72.7)
47 (69.1)
0.77
ACE inhibitor at admission, n (%)
43 (55.8)
37 (54.4)
1.0
Imaging/ EKG variables of ‘referred’
(N=77) and ‘unreferred’ (N=68) groups
Characteristic
Referred
group
(N=77)
Unreferred
group
(N=68)
P-Value
LVEF (%), Mean ± SD
25.6 ± 6.3
28.9 ± 6
<0.01
Ischemic Cardiomyopathy,
n (%)
50 (65)
42 (62)
0.82
Coronary Angiogram done,
n (%)
28 (36.4 )
12 (17.6 )
0.02
LVEF on angiogram (%),
Mean ± SD
24.6 ± 8.0
19.5 ± 13.6
0.14
Sinus Rhythm
45 (58.4)
36 (52.9)
0.62
Imaging/ EKG variables of ‘referred’
(N=77) and ‘unreferred’ (N=68) groups
Characteristic
Referred
Group
(N=77)
Unreferred
Group
(N=68)
26 (38.2)
P-Value
Atrial Fibrillation
23 (29.9)
0.38
QRS duration (ms), Mean
± SD
127.2 ± 41.5 120.0 ± 31.5
0.27
LVEDD (mm) Mean ± SD
60.9 ± 8.0
56.9 ± 7.0
<0.01
Severe Aortic Stenosis, n
(%)
1 (1.3)
8 (11.8)
0.01
Severe Mitral regurgitation, 3 (3.9)
n (%)
5 (7.4)
0.59
Severe Aortic regurgitation, 1 (1.3)
n (%)
1 (1.5)
1.0
Limited F/U data
• Cross sectional
• One patient from each group was found to
have AICD implanted in the interim period
before second hospitalization.
Discussion
• Only 53% of eligible patients had
documentation of such discussion
• AICD implantation: 53% of those referred
• Referred Patients:
– Younger
– Lower EF
Discussion (contd..)
• Most of the patients with severe Aortic
Stenosis: in unreferred group
– The need of aortic valve replacement
evaluation being of paramount importance.
– Not considered immediate candidates
– Such documentation was missing.
Discussion (contd..)
• Coronary Angiogram: 36.4 % in referred
group vs. 12 % in unreferred group
– Patients undergoing coronary angiogram
more likely to have a discussion about the
AICD.
– Acute presentation
– Consultative assistance
Discussion (contd..)
• Significant difference in the mean LVEDD:
– likely an incidental finding
– Sicker patients with lower EF.
• Also noted that, recommendations made
after procedures such as coronary
angiograms were more likely to be
followed by the team.
Conclusions
• AICD referral in only 53 %
– Need for improvement.
• Hospitalization provides an opportunity:
– Greater amount of time spent by patients
– Make an in-depth assessment
– Involve cardiovascular specialist
– Referral/ recommendations.
– Likely to be followed as out-patient as in CHF1
1Reibis
R, Dovifat C, Dissmann R, et al. Clin Res Cardiol. 2006 Mar;95(3):154-61.
Limitations
• Retrospective review type
• Cross sectional
• Dependence on documented medical
information.
Recommendation
• Despite limitations:
– A real life patient care outcome report
– Insight for the need to improve.
• Creation of ‘centralized recommendation’ from
points of diagnostic procedures
– Echocardiogram
– Radionuclide cardiac imaging
– Left ventriculography.
• Importance of medical records documentation
• Continued education of all the providers
Acknowledgement
•
•
•
•
•
Dr. Aravind Herle
Dr. Syed J Noor
Dr. Khalid J Qazi
CHS IRB Team
HIM Staff