Fact Sheet EECP Logo Contacting Us
Case Studies EECP Home Page
Literature Review Audio-Visual Presentations
Overview Comprehensive Heart Care Home Page

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 Deaths2 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.