Patient Outcome Statistics
1st 181 Patients
8/97 through 8/00
The EECP Center of Northwest Ohio is an active participant in the International EECP
Registry, which records patient status pre-EECP, then assesses short and long-term patient
outcome following treatment. The following statistical information was collected from the
181 patients treated over the 1st three years of our program.
Pre-EECP Clinical Status
The majority of our patients had inoperable recurrent coronary disease or were felt to
be at high risk for bypass or angioplasty. The remainder did not wish to be treated
invasively and chose to undergo EECP instead. Of these 181 patients:
· 121 had sustained a total of
158
heart attacks
· 86 had required a total of 100 bypass surgeries
· 77 had undergone a total of 141 angioplasty or
stent procedures
· 39 had needed bypass and angioplasty, 2 with
TMR
· Overall, 128 had required some form of revascularization
· 83% were in functional class 3-4(symptoms with mild
effort or at rest)
· 24% had three vessel disease, 48% two vessel,
26% single vessel, and 2% three vessel and left main blockage
· 144 were experiencing angina; 37 had painless ischemia
· The average ejection fraction was 43%. Heart pump
function was depressed in 80, with an average ejection fraction of 35%.
· 43, or 24%, had medically compensated congestive heart failure
· 1/3rd were diabetic; 13, or 7%, were on coumadin anticoagulation
· 3 were in atrial fibrillation and 8 had a pacemaker
· 10 had undergone carotid artery surgery; 17 had known
obstructive carotid disease and 11 had sustained a stroke
· 16 had symptomatic lower extremity vascular disease and
10
had required lower extremity vascular reconstructive surgery
Patient Outcome Following EECP
© Functional Class
·
Functional
Class improved in 178/181 patients (98%)
·
Average
Functional Class improved from 3.2
®
1.5
·
Functional class pre
and post-EECP in absolute numbers:
| Class |
Description |
Pre-EECP |
Post-EECP |
| 4 |
Angina at rest |
79 |
2 |
| 3 |
Symptoms with activities of daily living |
71 |
8 |
| 2 |
Angina only with greater than usual effort |
23 |
64 |
| 1 |
Symptom free or angina only with strenuous
effort |
5 |
107 |
·
Functional class pre
and post-EECP
expressed
as a percentage of patients
© Change from pre-EECP
Functional Class
| Pre-EECP |
Post-EECP Functional Class |
| Class |
No. |
Class 4 |
Class 3 |
Class 2 |
Class 1 |
Improved |
| Class 4 |
79 |
2 (2%) |
7 (9%) |
40 (51%) |
30 (38%) |
97% |
| Class 3 |
71 |
|
|
24 (34%) |
47 (66%) |
100% |
| Class 2 |
23 |
|
1 (4%) |
|
22 (96%) |
96% |
| Class 1 |
5 |
|
|
|
8 (100%) |
- |
© Stress Test Parameters
· 67 of our first 181 patients underwent pre and post-EECP treadmill stress tests:
Mean treadmill time:
7:07 ® 8:41
Treadmill time increased:
60/67
Treadmill time maintained:
5/67
Treadmill time decreased:
2/67
Treadmill time improved in 90%, improved or was maintained in 97%, and decreased in
4%.
Average treadmill time increased by 1:34, or 22%.
Dobutamine stress echo
studies normalized in 4 patients.
In
110 patients, post-EECP stress or dobutamine testing was not needed for clinical decision making and was not carried out.
© Angina Frequency and Medication Requirements
· 37 patients had painless ischemia. Of the 144
who were experiencing angina, 80 (56%) became angina free.
· 48% were able to cut back on their cardiac medications.
· Angina frequency decreased in 94%, from 7.1®
1.4 episodes/week.
· NTG use decreased in 92%, from 6.4 ®
1.1 NTG tabs/week
©
Change in Functional Class related to
·
Pre-EECP
disease
burden
· Prior
intervention status
Patients with native 3 vessel disease are sicker
to begin with and do not improve to the same
extent as do patients with native 1 and 2 vessel and post-bypass single vessel
disease. The 3 patients with
3 vessel and left main disease underwent EECP only because no other options were
available.
Patients with recurrent blockages following
angioplasty do just as well with EECP as do
individuals who have never been instrumented.
The relationship between the number of vessels blocked and
outcome is not as strong when EECP is provided to patients with recurrent
disease following both bypass surgery and a prior angioplasty or stent
procedure.
©
Clinical status 2-3 years out from EECP
87 of out 1st 181 patients are now 2 to 3
years out from their original EECP treatment. EECP is a therapeutic, not a
preventive treatment.
EECP alone cannot protect against progression of one’s
underlying
coronary disease, especially in
our typical
patient with inoperable coronary insufficiency. Still, 3-8 year post-EECP follow-up data is available in the
cardiology literature, so to make sure that
we are
carrying out EECP correctly, we have closely monitored the post-EECP
status of our
patients, and tabulated event rates to
the best of our ability (4 patients were lost to follow-up and are not included in this analysis).
Beginning with our 100th patient, 2
year pre-EECP event rate was recorded prospectively, and this
data is
presented as well. Comparing these event rates allows us to estimate the effect that
intervention with EECP will have on the overall course
of our patients.
When reviewing these numbers, please keep
in mind that we are working
with patients with far advanced cardiovascular disease.
| % |
Event Rate:
81 patients 2 years Pre-EECP |
|
16%
|
No Event |
| 13% |
26 has 34 Unplanned
Admissions: 7 heart
attacks, 3 CHF, 18 unstable angina,
3 strokes, 2 arrhythmia, 1 vascular surgery |
| 7% |
6 had 7 Bypass Surgeries,
2 with Trans-Myocardial Laser |
| 49% |
41 patients required 51 Heart
Catheterizations |
| 22% |
18 patients underwent 28 Angioplasty
/ Stent procedures |
| % |
Event Rate:
81 patients 2 years Post-EECP |
|
11%
|
9 had one or more Unplanned
Admissions: 1 heart attack, 2 CHF, 5 unstable angina, 1 with
stroke due to arrhythmia |
| 9% |
7 needed Bypass Surgery,
none urgent |
| 28% |
22
patients required Heart Catheterizations: 8 related
to an
unplanned
admission with symptoms, 9
elective, including 1 as part of a
research protocol, 6
elective prior to non-cardiac surgery
- all 6 benign |
| 7% |
6 patients underwent an Angioplasty
/ Stent procedure |
| 10% |
8 Deaths:
2
arrhythmia with end-stage heart disease, 1
stroke following hip surgery; 1 stroke due to arrhythmia,
2 refractory heart failure; 1 malignancy, & 1 post-bypass |
| 23% |
19 patients received Booster
Sessions of EECP |
| 78% |
No Event - 65/81
patients have not set foot in the hospital |
Discussion
of post-EECP events
9
unplanned hospitalizations:
A.
Patient stopped all meds on her own ®
severe hypertension ®
angina.
B.
Patient slipped and sustained
a hip fracture ®
died of stroke following surgery.
C.
CHF developed in a patient with impaired kidney function and EF of 30%.
D.
Inoperable patient sustained a small heart attack ®
angioplasty.
E.
Angina due to new vein graft failure ®
angioplasty.
F.
Recurrent angina due to disease progression ®
bypass.
G.
Probably non-cardiac pain ®
catheterization showed stable situation.
H. Angina
®
catheterization showed
stable situation.
I.
Recurrent angina due to disease progression
®
angioplasty
12
revascularization procedures:
·
Seven elective coronary bypass surgeries:
A.
Patient with two prior heart attacks and an EF of 30%.
Following EECP, angina fully resolved and treadmill time improved from 6 to 8 minutes, but his stress echo
remained abnormal.
Due to the young age of this patient an angiogram
was carried out,
revealing occlusion of 2 arteries, 2 vessels with 90% narrowings, and well
developed collaterals. Bypass
surgery went well; treadmill time remains
8 minutes following bypass and ischemia can no longer be brought out.
B.
Patient with single vessel disease by prior catheterization didn’t
improve with EECP.
Angiography demonstrated
unexpected disease progression, with RCA
occlusion, 70% LAD, and 60% Left Main narrowings.
Bypass was carried
out without incident.
C.
Patient with prior coronary and lower extremity bypass surgeries, and two
prior coronary and one prior lower extremity
PTCA procedures, experienced a flare-up of angina following initially
successful EECP.
Angiography demonstrated one
patent and one occluded graft, two severely narrowed grafts, and preserved heart pumping function.
Bypass surgery was
carried out without difficulty.
D.
Patient with aortic stenosis and angina; initially did not wish to undergo
angiography and did well with EECP.
Symptoms returned ®
catheterization ®
bypass and aortic valve replacement
E. Patient did not wish to undergo angiography and
did well with EECP. Symptoms
returned ® catheterization ®
bypass ®
subsequent angioplasty for graft closure.
F. Patient with prior bypass surgery and multiple
failed angioplasties. Initially
did well with EECP.
Angina
recurred and he needed carotid artery surgery ®
catheterization ® coronary bypass
and carotid surgery ® subsequent graft
closure and death.
G.
Patient with initial good response to EECP.
Angina recurred ® catheterization showed new
blockages ®
bypass surgery.
·
6 PTCA procedures; 5 elective, 1 following a small heart attack:
A.
Patient with RCA occlusion and multiple high grade narrowings just two years
out from bypass surgery. PTCA
was felt to
be too high a risk by one interventional cardiologist; a 2nd offered 4 vessel angioplasty. Following
EECP angina decreased, functional class improved from 4 to 2, and treadmill time increased. Angina recurred
while out of town. The
cardiologist there carried out a heart catheterization, demonstrating
multivessel disease with well developed collaterals. This cardiologist
did not
know about EECP and its
effects and carried out angioplasty on several vessels.
B. Elderly diabetic patient with two prior heart
attacks, an EF of 35%, one prior stroke, failed bypass
two years earlier, and
a significant carotid artery narrowing refused further bypass surgery and underwent EECP. Functional class improved from 4 to 2 and NTG was no longer required. Later she sustained a small heart attack.
Angiography demonstrated multivessel coronary
disease and produced
transient kidney failure; angioplasty of 3 vessels was carried out.
C.
Young diabetic patient with a hereditary lipid abnormality, a prior heart
attack followed by angioplasty and later bypass
surgery, experienced angina
felt to be due to graft dysfunction. With
EECP, angina improved from class 4 to class 2 and
treadmill time increased.
Angina recurred and angiography demonstrated progressive graft disease,
compromising his
augmented collaterals.
Multivessel
angioplasty was carried out.
D. 93 year old patient with poorly operable coronary
disease did well with EECP. Two
years later shortness of breath became problematic and he wanted to be able to
do more
® catheterization
® single vessel angioplasty
E. Patient with prior bypass surgery and multiple
failed angioplasties. Excellent
response to EECP. Angina recurred
® catheterization
® new vein graft occlusion
® angioplasty
F. Patient with prior bypass surgery and multiple
failed angioplasties. Excellent
response to EECP. Angina recurred
® catheterization
® new vein graft occlusion
®
angioplasty
·
8 patients died, 7 due to cardiovascular disease, 1 due to malignancy:
A.
Patient with advanced disease, undergoing EECP for inoperable angina,
experienced a reduction in BP related to dialysis
and IV iron
administration; medications had to be decreased®
angina & CHF®
death.
B.
One patient improved significantly with EECP.
He slipped and fell at home, sustaining a hip fracture,
and died of a
stroke following urgent hip surgery.
C.
Patient with renal insufficiency and an EF of 30%, required hospitalization
for CHF. Symptoms
cleared with a change in
medical therapy.
1-2 weeks later he died in his sleep, most likely due to a
cardiac
rhythm disturbance.
D. 91 year old patients with advanced disease and a satisfactory response
to EECP; 3 months later
he died following a fall, presumably due to
arrhythmia.
E. Patient with advanced disease and a good response to EECP. Later she stopped all
of her meds ®
BP, angina, & arrhythmia ®
died of a stroke.
F. Patient with inoperable three vessel and left main blockage; angina
improved with EECP but later he
died of CHF.
G.
Patient with prior bypass surgery and multiple failed angioplasties.
Initially did well with EECP.
Angina
recurred and
he needed carotid artery surgery ®
catheterization ®
bypass and carotid surgery ®
subsequent graft closure and death.
H. Patient with satisfactory response to EECP; later
died of a malignancy.
·
EECP related complications:
A. Minor, self-limiting complications, such as skin
abrasion, or aggravation of arthritic, hemorrhoidal,
or hernia pain
occur occasionally.
B. Two vascular events, possibly related to EECP,
occurred during our 1st 3 years:
A patient whose angina was responding well to EECP experienced a stroke
on the evening between her 19th and 20th treatments.
A carotid ultrasound returned benign, and the problem
was felt to be
due to blockages in the posterior cerebral,
or vertebral vessels.
Stroke is not felt to be a complication of EECP, and in China EECP is
used as a treatment for stroke.
11
of our 1st 181 patients had experienced a stroke prior to
undergoing EECP, so this patient’s event was likely due to
her underlying
vascular disease, and not a direct complication of EECP.
A patient had undergone urgent angiography, revealing an inoperable
coronary picture. The
femoral
artery puncture
site was closed with a collagen plug, utilizing an
intra-arterial fixation system. EECP
was begun 10 days later and the
patient experienced foot pain and toe
discoloration, consistent with embolism of blood clot.
A vascular evaluation returned benign, and the patient’s symptoms
resolved on their own. EECP was
later resumed without incident. Likely,
a small clot related to the arterial collagen plug was mobilized during EECP.
EECP Center of NW Ohio - Status as of
7/20/00
181 patients have completed a full course of EECP
15
patients are currently being treated with EECP
24
patients discontinued EECP early:
8 due to loss of interest, transport or insurance
problems
3 due to arthritic
discomfort/intolerance
6 due to non-cardiac illness
12
due to restenosis following angioplasty
3 due to persistent
pain
1 due to CHF and 1 due to CVA
EECP Center of Northwest Ohio
© 1st
181 patients, 8/97 through 8/00 - Summary
·
Chest
pain improved in 94%, on average from 7.1 to 1.4 episodes/week;
56% became angina free
·
NTG use
decreased in 94%, on average from 6.4 to 1.1 tabs/week
·
Functional
Class improved in 98%
·
Treadmill
time improved in 90%, on average by 22%
· 48% of
our patients were able to decrease their medications
· 93% have not required PTCA or surgical revascularization
· 89% without an unplanned hospital admission
· 78% have not set foot in the hospital after undergoing EECP
· No patient has died during their course of EECP
·
One
patient experienced a stroke, probably incidental to their course of
EECP; no patient has experienced an infection, respiratory or kidney failure
as a consequence of
EECP.
The EECP Center of Northwest Ohio was established in
8/97 as the 30th EECP Center in the US. With 3 EECP tables, we
have been one of the most active of the now nearly 1000 American EECP providers, in
‘98 accounting for 25% of the patients in the International EECP Registry
Study. Our EECP therapists are ACLS certified
and have a background in
cardiac nursing. Mrs.
Deborah Braun is our Practice Administrator and Research Coordinator.
James C. Roberts MD FACC is our center’s Medical Director.
Dr. Roberts is board certified in Cardiology and Internal Medicine, and
has practiced clinical, preventive, and invasive cardiology in the Toledo area
since 1987. Dr. Roberts is a
Fellow of The American College of Cardiology.
Dr. Roberts established the Doppler, Color Doppler, and Transesophageal
Cardiac Echo programs at St. Vincents Medical Center, and participated in the
formation of the Cardiology-Radiology Nuclear Cardiology Reading Panel at the
same institution. Dr. Roberts was
the first cardiologist in this region to provide intraoperative echo
monitoring, to assist heart surgeons during mitral valve repair procedures.
Dr. Roberts’ interests focus on EECP, clinical cardiology, and the
use of risk factor reduction techniques to control atherosclerosis, stabilize
coronary narrowings, and help prevent disease progression or recurrence.
Dr. Roberts has lectured on EECP to physician groups in 5 states and in
Mexico.
