PERTINENT REFERENCES EXPLAINING THE ACTION OF THE
CIRCULATOR BOOT, RELATED MATTERS.
BRIEF SUMMARY OF THE ARTICLE INCLUDED.
1. Abu-Own A, Cheatle T, Scurr JH, and Smith PDC: Effects of intermittent pneumatic compression of the foot on the microcirculatory function in arterial disease. Eur J Vasc Surg 7: 488-492, 1933. The venous pump of the foot assists blood returning to the heart. The aim of this study was to evaluate the effect of mechanical activation of the foot pump on the microcirculation of the skin in patients with peripheral occlusive arterial disease.
2. Agerskov K, Tofft HP, Jensen FB, Engel HC: External negative thigh pressure. Effect upon blood flow and pressure in the foot in patients with occlusive arterial disease. Dan Med Bul 37:451-4, 1990. We studied the effect of external application of 35-45 mmHg negative pressure around the thigh on toe blood pressure and skin blood flow in nine patients with occlusion of the superficial femoral artery and rest pain/severe intermittent claudication. We conclude that 35-45 mmHg negative pressure around the thigh in patients with occlusionof the superficial femoral artery induce increased blood perfusion in the foot, possibly due to changes in collateral arterial resistance in the thigh.
3. Alpagut U, Dayioglu E: Importance and advantages of intermittent external pneumatic compression therapy in venous stasis ulceration. Angiology. 56: 19-23, 2005. Venous ulcers are seen postthrombophlebitic syndromewith venous insufficiency and can begin as result of minor trauma. In this retrospective study the authors examined the value of external intermittent pneumatic compression therapy in chronic venous ulcers. Results revealed that this modality of therapy shortens the therapy duration, lowers the total therapy cost, and hastens the return to active lifein comparison to the classical therapy with compression stockingsand antiaggregant or low dose oral anticoagulant therapy. In the light of their findings they propose the wider use of this adjuvant therapy.
4. Amsterdam EA, Lee g, Tonkon MJ, DeMaria AN and Matson DT: Noninvasive circulatory assistance by external counterpulsation. Chapter 14 in Advances in Heart Disease, Volume I, Mason DT editor. Grune & Stratton New York, 1977. The duration of applied pressure was approximately 250 msec. In normal subjects diastolic blood pressure was elevated 40-70% and cardiac output increased 15-60% during the treatment. Treatment of angina patients for one hour daily for 5 days resulted in symptomatic improvement in 17 of 21 individuals with definitely improved angiograms in 5 of 11 and equivocally improved angiograms in 4 of the 11 patients undergoing coronary angiography. An increased vascularity was seen in the angiograms.
5. Applebaum RM, Kasliwal R, Tunick PA, Konecky N, Katz ES, Trehan N and Kronzon I: Sequential external counterpulsation increases cerebral and renal blood flow. Am Heart J 133: 611-615, 1997. Abstract: The purpose of this study was to evaluate the effect of sequential external counterpulsation (SECP) on cerebral and renal blood flow. This noninvasive, harmless treatment may be useful to support patients with decreased cerebral and renal perfusion.
6. Blackshear WM, Pescott C, LePain F, Benoit S, Dickstein R, Seifert KB: Influence of sequential pneumatic compression on postoperative venous function. J Vasc Surg 5: 432-6, 1987. The authors hypothesized that the improvement in venous function was induced by the direct mechanical effects of pumping on the vessel wall, humoral or neurogenic factors , or a Venturi effect through increased flow velocity in the vena cava.
7. Bolli R, Marban E: Molecular and cellular mechanisms of myocardial stunning. Physiol Rev 79: 609-34, 1999. The past two decades have witnessed an explosive growth of knowledge regarding postischemic myocardial dysfunction or myocardial “ stunning “. The purpose of this review is to summarize current information regarding the pathophysiology and pathogenesis of this phenomenon.
8. Bonetti PO, Holmes DR Jr, Lerman A, Barsness GW: Enhanced external counterpulsation for ischemic heart disease: what’s behind the curtain? J Am Coll Cardiol 41: 1918-25, 2003. Suggested mechanisms contributing to the clinical benefit of EECP include improvement in endothelial function, promotion of coronary collateralization, enhancement of ventricular function, peripheral effects similar to those observed with regular physical exercise, and nonspecific placebo effects. This review summarizes the current evidence for a contribution of these mechanisms to the clinical benefit associated with EECP.
9. Brandjes DP, Buller HR, Heijboer H et al: Compression stockings reduced the occurrence of post-thrombotic syndrome in proximal DVT: Lancet 349: 759-62, 1977. Sized-to-fit, knee-length, graded compression stockingssignificantly reduced the occurrence of mild-to-moderate and severe post-thrombotic syndrome in patients with a first episode of proximal deep vein thrombosis.
10. Cheung AT, Savino JS, Weiss SJ: Beat-to-beat augmentation of left ventricular function by intraaortic counterpulsation. Anesthesiology 1996 Mar; 84 (3):545-54. Measuring the effects of intraaortic ballooncounterpulsation (IABP) in single cardiac beats may permit an improved understanding of the physiology mechanisms by which IABP improves the circulation. The relationship between left ventricular systolic function and left ventricular systolic wall stress during IABP support suggests that afterload reduction was an important mechanism by which IABP instantaneously improved circulatory function in anesthetized cardiac surgical patients. Comments : And these effects are found with the decompression of a small intraaortic balloon. See Dillon 1998 below for similar large effects seen with the decompression of the Circulator Boot.
11. Chelboun GS, Howell JN, Baker HL, Ballard TN, graham JL, Hallman HL, Perkins LE, Schauss JH and Conatser RR: Intermittent pneumatic compression effect on eccentric exercise-induced swelling, stiffness, and strength loss. Arch Phys Med Rehabil 76: 744-749, 1995. Authors conclude that therapy is effective in temporarily decreasing the swelling and stiffness after exercise-induced muscle injury.
12. Delis KT, Nicolaides AN, Wolfe JH, Stansby G: Improving walking ability and ankle brachial pressure indices in symptomatic peripheral vascular disease with intermittent pneumatic foot compression: a prospective controlled study with one year follow-up. J Vasc Surg 31: 650-61, 2000. Conclusion: Intermittent pneumatic foot compression used at home for 4-5 months increases claudication distance by 100%.
13. Delis KT, Nicolaides AN, Labropoulos N, Stansby G: The acute effects of intermittent pneumatic foot versus calf versus simultaneous foot and calf compression on popliteal artery hemodynamics: a comparative study. J Vasc Surg 32: 284-92, 2000. Intermittent pneumatic compression (IPC) is currently being investigated with respect to its effect on distal arterial volume flow in patients with peripheral vascular disease. Recently published data have shown a substantial acute enhancement in arterial calf inflow in response to IPCof the lower limb in both intermittent claudication and leg ischemia. The significant increase in end diastolic velocity and decrease in pulsatility index indicate that peripheral vasodilatation is the central mechanism in this related flow augmentation.
14. Delis KT, Knaggs AL: Duration and amplitude decay of acute arterial leg inflow enhancement with intermittent pneumatic leg compression: an insight into the implicated physiologic mechanisms. J Vasc Surg 42 (4): 717-25, 2005. By acutely enhancing the arterial leg inflow, intermittent pneumatic leg compression (IPC) improves the walking ability, arterial hemodynamics, and quality of life of claudicants.
15. Delis KT, Nicolaides AN: Effect of Intermittent Pneumatic Compression of Foot and Calf on Walking Distance, Hemodynamics, and Quality of Life in Patients With Arterial Claudication. A Prospective Randomized Study With 1 Year Follow-up. Ann Surg 241: 431-441, 2005. Conclusions: IPC foot+calf emerged as an effective, high compliance, complication-free method for improving the walking ability and pressure indices in stable claudication, with a durable outcome.
16. De Simone G, Di Lorenzo L, Ferrara LA, Costantino G, Fasano ML, Soro S, Mancini M: Noninvasive assessment of hemodynamic changes during therapy with nitrendipine in arterial hypertension. Jpn Heart J 28: 73-84, 1987.
17. Dillon RS: An end-diastolic air compression boot for circulation augmentation. J ClinEngineering 3: 63, 1980. Description of Circulator Boot systems and comparison with other pneumatic boots.
18. Dillon RS: Effect of therapy with pneumatic end-diastolic leg compression boot on peripheral vascular tests and on the clinical course of peripheral vascular disease. Angiology 31: 614-638, 1980. The Circulator Boot is a new end-diastolic pneumatic leg compression device. This report describes its effect on 6 normal young people, 8 ambulatory patients with mild peripheral arterial disease, and 21 consecutive patients (of whom 18 were hospitalized ) with severe peripheral arterial disease in 25 legs. The long-term beneficial effects of boot therapy may be related to improved collateral flow and to the rechanneling of obstructed vessels.
19. Dillon RS: Treatment of resistant venous stasis ulcers and dermatitis with the end-diastolic pneumatic compression boot (TM). Angiology 37: 47-56, 1986. Abstract: The end-diastolic pneumatic compression boot used to treat 17 patients with difficult or refractory stasis dermatitis and ulcers. Decreases in duration, pigmentation, and palpable thrombi were observed and all patients were improved or healed. Comments: Venous stasis ulcers are really ischemic lesions in which the blockage is on the venous side, rather than on the arterial side. Booting restores venous blood flow in promoting the dissolution of the venous thrombi and reducing induration and edema. Arterial vascular tests significantly improved with the boot treatments in the 7 patients who had concomitant arterial disease. Pulmonary emboli were not a problem.
20. Dillon RS: Successful treatment of osteomyelitis and soft tissue infections in ischemic diabetic legs by antibiotic injections and the end-diastolic pneumatic compression boot. Ann Surg 204: 643-649, 1986.
21. Dillon RS: Treatment of osteomyelitis in diabetic foot with systemic and locally-injected antibiotics and the end-diastolic pneumatic compression boot- Case studies. Vasc Surg (Westerminister Press) 24: 682-695, 1990. The osteomyelitis lesions healed and foot structure and function were maintained.
22. Dillon RS: Optimizing external cardiac-assist compressions in patients with atrial fibrillation by anticipating the next beat. Angiology 47: 123-129, 1996. An empirical formula was developed and tested on the computer to significantly improve the efficiency of the Circulator Boot in assisting the hearts of patients with atrial fibrillation.
23. Dillon RS: Fifteen years of experience in treating 2177 episodes of foot and leg lesions with the Circulator Boot-Results of treatments with the Circulator Boot. Angiology 48, Number 5, Part 2: S17-S34, 1997. To determine the clinical effectiveness of the end-diastolic pneumatic compression boot and of local antibiotics in treating limb lesions associated with diabetes and peripheral arterial, venous and neuropathic disease. Results: Healing or improvement of treated legs was seen above that in the literature in all Wagner categories and was significant (P<0.001) compared to the “control leg” which deteriorated in 38.7% of patients. Significant risk factors against a successful outcome included smoking, inability to walk, increased home distance from the boot center, loss to treatment, hemodialysis, a Wagner 4-5 classification, inoperable iliac occlusions, vascular surgical procedures before or after referral for boot therapy and an aggressive vascular surgeon.
24. Dillon RS: Patient assessment and examples of a method of treatment-use of the Circulator Boot in peripheral vascular disease. Angiology 48, Number 5, Part 2: S35-S58, 1997. A method of treatment includes the use of the boot and the injection of local antibiotics is described.
25. Dillon RS: Improved hemodynamics shown by continuous monitoring of electrical impedance during external counterpulsation with the end-diastolic pneumatic boot and improved ambulatory EKG monitoring after 3 weeks of therapy. Angiology 49: 523-535, 1998.
26. Dillon RS: Pathophysiology of diabetic foot lesions and their treatment with the Circulator Boot-TM. Chapter 13 in “ The Wound Management Manual” pages 141-211. Bok Y. Lee editor. McGraw-Hill, 2005.
27. Eze AR, Comerota AJ, Cisek PL, Holland BS, Kerr RP, Veeramasuneni R and Comerota Jr. AJ: Intermittent calf and foot compression increases lower extremity blood flow. Am J Surg 172: 130-135, 1996. Authors conclusions: Measured in the sitting position, the resting popliteal artery blood flow and foot skin perfusion are greater in patients with SFA occlusioncompared to normal volunteers.
28. Filip, John: APWCA Case study#2: Application of end-diastolic pneumatic compression therapy with the Circulator Boot. Podiatry Management 26(9): 149-159, 2007. Illustrated case report in which a lady with advanced lesions of both legs and feet spared bilateral amputations.
29. Filip JR, Dillon RS: Treatment of end-stage “trash feet” with the end-diastolic pneumatic boot. Angiology 59 (2): 214-9, 2008. This study reassessed the clinical effect of Circulator Boot-TM, CB therapy in patients with cholesterol embolization syndrome, (CES) of the lower extremities. The medical records were reviewed of 27 patients consecutively referred to the Bryn Mawr Wound Care and Vascular Center, with CES who had not responded to previous therapies. All patients with CES referred from January 1, 1997, to September 19, 2005, were followed-up and included in the study. The alternate therapy offered for most patients at the time of referral was limb amputation. The median age of the patients was 65 years ( age range 46-84 years) at the time of diagnosis. Healing of CES was observed after a median interval of 11 months (range, 3-32 months) following the initiation of CB therapy. The total number of legs treated was 41. Of 41 legs, 33 (81%) were totally healed, 6 (15%) improved and 2 (5%) were amputated. After an initial period of improvement one patient died a month later of causes unrelated to CES or to CB therapy. Cholesterol embolization is seen predominantly in patients following cardiac or vascular procedures but may occur spontaneously. The CB seems to be the only effective noninvasive therapy for CES. Early initiation of therapy is essential to minimize tissue loss and patient discomfort.
30. Fisher CG, Blachut PA, Salvian AJ, Meek RN, and O’Brien PJ: Effectiveness of pneumatic compression devices for the prevention of thromboembolic disease in orthopaedic trauma patients: a prospective randomized study of compression alone versus no prophylaxis. J Ortho Trauma 9: 1-7, 1995.
31. Gilbart MK, Oglivie-Harris DJ, Broadhurst C and Clarfield M: Anterior tibial compartment during intermittent sequential pneumatic compression therapy. Am J Sports Med 23: 769-772, 1995.
32. Ginsberg JS, Brill-Edwards P, Kowalchuk G, Hirsh J: Intermittent compression units for the postphlebitic syndrome. A pilot study. Arch Intern Med 149: 1651-2, 1989. Patients studied had dramatic improvement in symptoms and functional status without side effects.
33. Goldman BS, Hill TJ, Rosenthal GA, Scully HE, Weisel RD and Baird RJ: Complications associated with use of the intraaortic balloon pump. Canad J Surg 25: 153-156, 1982. 299 patients between 1977 and 1979.
34. Gruenes J, Nelson JP et al: An evaluation of the efficacy of the Circulator Boot-TM in altering hemodynamics of the ischemic lower extremity and foot. Midwest Podiatry Conference 2005 (Chicago). Barry University School of Grad Med Sci. Every pumped extremity had increased perfusion after four weeks with an average increase of 43%. Twelve of 13 long term ulcers healed during the study.
35. Han JH, Leung TW, Lam WW et al: Preliminary Findings of External Counterpulsation for Ischemic Stroke Patient With Large Artery Occlusive Disease. Stroke 39: 1340-3, 2008. CONCLUSIONS: ECP is feasible for ischemic stroke patients with larger artery disease.
36. Henein MY, Das SK, O’Sullivan C, Kakkar W, Gillbe CE, Gibson DG: Effect of acute alterations in afterload on left ventricular function in patients with combined coronary artery and peripheral vascular disease. Heart 75 (2): 151-8, 1966. Abstract: Conclusion: Resting left ventricular long axis function is abnormal with patients with combined coronary artery and peripheral vascular disease. It is unaffected by anesthesia but deteriorates with aortic or iliac clamping, although blood pressure remains unchanged. It promptly improves with unclamping after successful peripheral arterial reconstruction. Thus even in apparently stable coronary artery disease, resting subendocardial function is labile, showing pronounced alterations with changing after-load, even when arterial pressure itself does not change.
37. Ho CK, Sun MP, Au TW, Chiu CS: Pneumatic pump reduces leg wound complications in cardiac patients. Asian Cardiovasc Thorac Ann 14: 452-7, 2006. The sequential pneumatic leg pump is an effective, inexpensive, and convenient device that reduces leg wound complications after coronary artery bypass grafting.
38. Kakkos SK, Geroulakos G, Nicolaides AN: Improvement of the walking ability in intermittent claudication due to superficial femoral artery occlusion with supervised exercise and pneumatic foot and calf compression: a randomized controlled trial. Eur J Vasc Endovasc Surg 30: 164-75, 2005. CONCLUSIONS: IPC, by augmenting leg perfusion, achieved improvement in walking distance comparable with supervised exercise. Long-term results in a larger number of patients will provide valuable information on the optimal treatment modality of intermittent claudication.
39. Katz ES, Tunick PA and Kronzon I: Observations of coronary flow augmentation and balloon function during intraaortic ballon counterpulsation using transesophageal echocardiography. Am J Cardiol 69: 1635-1639, 1992. “Noninvasively, transesophageal echocardiography “ TEE “…has demonstrated efficacy in enabling visualization of the proximal left coronary artery and in recording coronary blood flow velocity”…in 6 studied patients…”Peak diastolic coronary blood flow velocity increased by a mean of 117% (range 62 to 287 ) during balloon inflation ( P= 0.002 ). Furthermore, coronary flow velocity integral increased by a mean of 87% ( range 43 to 176; P = 0.003).” Balloon function and position also evaluated.
40. Kavros SJ, Delis KT, Turner NS, Voll AE, Liedl DA, Gloviczki P, RookeTW: Improving limb salvage in critical ischemia with intermittent pneumatic compression: a controlled study with 18 month follow-up. J Vasc Surg 47(3): 543-9, 2008. CONCLUSION: IPC used as an adjunct to wound care patients with chronic critical limb ischemia and nonhealing amputation wounds/tissue loss improves the likelihood of wound healing and limb salvage when established treatment alternatives in current practice are lacking. This controlled study adds to the momentum of IPC clinical efficacy in critical limb ischemia set by previously published case series.
41. Keith SL, McLaughlin DJ, Anderson FA Jr., Cardullo PA, Jones CE, Rohrer MJ, Cutler BS: Do graduated compression stockings and pneumatic boots have an additive effect on the peak velocity of venous blood flow? Arch Surg 127(6): 727-30, 1992. This study demonstrates that the simultaneous use of graduated compression stockings and intermittent pneumatic compression boots does not produce a synergistic augmentation of peak venous velocity in the superficial femoral vein.
42. Kern MJ, Henry RH, Lembo N, Park RC, Lujan MS, Ferry D and O’Rourke RA: Effects of pulsed external augmentation of diastolic pressure on coronary and systemic hemodynamics in patients with coronary artery disease. Am Heart J 110: 727-735, 1985. External diastolic pressure augmentation did not affect heart rate, right heart hemodynamics, cardiac output or calculated oxygen oxygen consumption. An unanticipated finding was a greater than or equal to 10% reduction in peak systolic pressure during external diastolic pressure augmentation in 8 of the 14 patients. The increase in the diastolic pressure-time/systolic pressure-timeindex suggests that subendocardial perfusion may be favorably influenced by diastolic pressure augmentation. Their leg pressure was applied 240 msec after the Q-wave of the EKG and was applied for 340 msec. Doppler studies showed a reversal of flow in the femoral artery.
43. Knight MTN and Dawson K: Effect of intermittent compression of the arms on deep vein thrombosis in the legs. Lancet 2: 1265, 1976. Arm pumping decreased euglobulin lysis time and was associated with a decrease in leg thrombi.
44. Koch CA: External leg compression in the treatment of vascular disease. Angiology 48, Number 5, Part 2: S3-S15, 1997. In summary, external compression of the limbs is a mode of therapy which has enjoyed a long history in the treatment of venous and arterial disease. Evidence suggests that its beneficial effects are mediated through enhancement of venous and arterial blood flow, promotion of vasodilatation, enhancement of fibrinolysis and in the case of obstructive arterial disease, promotion of the development of collateral circulation. The utility of external leg compression in the prevention of deep venous thrombosis and in the management of chronic venous stasisdisease, has been well documented, and it has become an accepted treatment for these disorders. The use of pneumatic compression in the treatment of atherosclerotic peripheral vascular and cardiovascular disease show striking benefit of the technique. Potential benefits to patients of external limb compression therapy include its noninvasive nature, its ability to be applied in the outpatient setting, and long-term cost savings through possible avoidance of hospitalization and invasive procedures.
45. Kumbasar SD, Semiz E, Sancaktar O, Yalcinkaya S, Ermis C and Deger N: Concomitant use of the intraaortic balloon counterpulsation and streptokinase in acute myocardial infarction. Angiology 50: 465-471, 1999. The preliminary results of this study suggest that concomitant use of IABP and streptokinase in acute anterior MI increases the incidence of TIMI grade 3 flowand may have decreased the in-hospital mortalityrate without unacceptable rates of vascular or hemorrhagic complications.
46. Landis EM and Hitzrot LH: treatment of peripheral vascular disease by means of suction pressure. Ann Intern Med 3: 1, 1935.
47. Labropoulos N, Watson WC, Mansour MA, Kang SS, Littooy FN, Baker WH: Acute effects of intermittent compression on popliteal artery blood flow. Arch Surg 133: 1072-5, 1998. Results: Including all types of variability, the popliteal artery blood flowvaried from 8% to 39% with a mean value of 19%. Since the diameter of the artery was obtained with less than 5% variability, the time average mean velocity was responsible for the high variation in flow. During application of the IPFCC, the popliteal artery blood flow increased significantly in all subjects (P<0.001). The mean increase in flow was 2.4 times baseline values. The diameter of the arteries remained unchanged while the time average velocity increased significantly (P><0.001). This velocity increase was due to marked elevation in the peak systolic and end diastolic velocities and diminution of the reverse-flow component, as well as a prolongation of the forward flow during diastole. After cessation of the pump, flow returned to baseline levels (P=.41).
48. Labropoulos N.1; Wierks C.1; Suffoletto B.1: Intermittent pneumatic compression for the treatment of lower extremity arterial disease: a systemic review. Vascular Medicine 7: 141-148, 2002. In conclusion: it is evident that an intermittent pneumatic compression program appears promising and may be used in patients with severe peripheral arterial diseasewho are not candidates for revascularization using surgery or percutaneous angioplasty.
49. Labropoulos N, Leon LR, Bhatti A et al: Hemodynamic effects of intermittent pneumatic compression in patients with critical limb ischemia. J Vas Surg 42: 710-6, 2005. CONCLUSIONS:IPC increases axial, muscular, collateral and skin blood flow in patients with CLI and may be beneficial to those who are not candidates for revascularization. Patients with significant venous reflux may not benefit from IPC. This supports the theory that one of the mechanisms by which IPC enhances flowis by increasing the arteriovenous pressure gradient.
50. Lawson WE, Hui JCK, Soroff HS, Zheng ZS, Kayden DS, Sasvary D, Atkins H and Cohn PF: Efficacy of enhanced external counterpulsation in treatment of angina pectoris. Am J Cardiol 70: 859-862, 1992. Authors claim that EECP uses high balloons and sequenced balloon inflation thus improving their diastolic augmentation over previously available methods. Exclusion criteria included clinical CHF, aortic insufficiency , recent myocardial infarction (last 3 months), significant ventricular ectopy or atrial fibrillation, nonischemic cardiomyopathy, severe occlusive peripheral vascular disease, recurrent deep vein thrombophlebitis, systemic hypertension and a bleeding diathesis.
51. Lawson WE, Zheng ZS, Oster Z, Katz JP, Diggs P, Burger L, Cohn CD, Soroff HS and Cohn PF: Three-year sustained benefit from external counterpulsation in chronic angina pectoris: Am J Cardiol 75: 840-841, 1995. Follow-up of 18 patients with positive thallium stress tests who were given 36 hours of EECP. Studied within a week after the treatment, 11 patients no longer had evidence of ischemia with the same cardiac workload, 3 had less ischemia, and 4 were unchanged. Over the next three years, 8 patients received supplemental EECP. At the three year follow-up, 8 of the 14 patients with initial improvement remained negative, one was lost to follow-up, one refused follow-up stress testing, two had reverted to positive tests, one had a myocardial infarction and one had a coronary bypass graft (CABG). Of the four with ischemia before and after their initial EECP, two had continued abnormal tests, one had PTCA and one had CABG.
52. Lawson WE, Hui JCK, Zheng ZS, Burger L, Jiang L, Lillis O, Soroff HS and Cohn PF: Can angiographic findings predict which coronary patients will benefit from enhanced external counterpulsation? Am J Cardiol 77: 1107-1109, 1996. EECP may offer promise in some patients in whom complete revascularization is not feasible; in such cases , palliative PTCA or CABG may decrease the coronary artery diseaseextent to residual 1- or 2 vessel disease that might benefit from counterpulsation.
53. Lawson WE, Hui JCK, Zheng ZS, Burger L, Jiang L, Lillis O, Soroff HS and Cohn PF: Improved exercise tolerance following enhanced external counterpulsation: cardiac peripheral effecst ? Cardiology 87: 271-275, 1996. Post EECP maximum exercise heart rate and blood pressure, while demonstrating a linear relation with exercise duration, did not increase significantly despite the increased exercise duration. This, the authors suggest, may mean that the increase in exercise duration after treatment was due to both an improved myocardial perfusion and altered exercise hemodynamics. EECP thus appears to exert a “training” effect, decreasing peripheral vascular resistance and heart rate response to exercise. Coronary disease patients may improve their exercise tolerance after EECP because of both improved myocardial perfusion and a decrease in cardiac workload.
54. Lawson WE, Hui JCK, Oster ZH, Zheng ZS, Cabahug C, Katz JP, Dervan JP, Burger L, Jiang L, Soroff HS and Cohn PF: Enhanced external counterpulsation as an adjunct to revascularization in unstable angina. Clin Cardiol 20: 178-180, 1997. Post EECP, angina was relieved, thallium defects were resolved, and the patient remained asymptomatic for 36 months.
55. Lippman HI, Fishman LM, Farrar RH, Bernstein RK and Zybvert PA: Edema control in the management of disabling chronic venous insufficiency. Arch Phys Med Rehabil 75: 436-441, 1994. A 15 year retrospective study the biomedical and socioeconomic rationale of edema control in disabling chronic venous insufficiency…2317 patients…Unna boot used for ulceration and compression hosiery used for prevention of ulceration…Approximate overall healing rate 60.9%....The Unna boot is relatively cheap but does require regular clinic visits for replacement.
56. Liu K, Chen LE, Seaber AV, Urbaniak JR: Influences of inflation rate and duration of vasodilatory effect by intermittent compression in distant skeletal muscle. J Orthop Res 17(3): 415-420, 1999. Previous study has demonstrated that application of intermittent pneumatic compression on legs can cause vasodilation in distant skeletal muscles at the microcirculation level. This study evaluated the influence of inflation rate and peak pressure duration on the vasodilatory effects of intermittent pneumatic compression. The findings suggest that inflation rate plays an important rolein the modulation of distant microcirculation induced by intermittent pneumatic compression whereas peak pressure duration does not significantly influence the vasodilatory effects of the compression. This may be due to the fact that rapid inflation produces a significant increase in shear stress on the vascular wall, which stimulates vascular endothelium to release nitric oxide, causing systemic vasodilation.
57. Loh PH, Louis AA, Windram J, Rigby AS, Cook J, Hurren S, Nikolay NP, Caplin J, Cleland JG: The immediate and long-term outcome of enhanced external counterpulsation in treatment of chronic stable refractory angina. J Intern Med 259: 276-84, 2006. This study shows that for patients who fail to respond to conventional measures, a high proportion gain symptomatic benefit from EECP.
58. Makhoul RG, Cole CW and McCann RL: Vascular complications of the intraaortic balloon pump: an analysis of 436 patients. The Amer Surgeon 59: 564-568, 1993. Indications for balloon therapy: intraoperative pump failure (42%), unstable angina (24%), preoperative prophylaxis (22%), preoperative shock (9%), and postoperative support (3%). Vascular complications occurred in 46 patients (10.6%) with leg ischemia, the problem in 40 of the 46. Only the absence of pedal pulses on admission correlated with an increase in vascular complications.
59. McCulloch JM, Marler KC, Neal MB and Phifer TG: Intermittent pneumatic compression improves venous ulcer healing. Advances in Wound Care 7: 22-26, 1994. The results appear to indicate that intermittent compression is beneficial in the management of venous insufficiency ulcers.
60. Montori VM, Kavros SJ, Walsh EE, Rooke TW: Intermittent compression pump for nonhealing wounds in patients with limb ischemia. The Mayo Clinic Experience (1998-2000). Int Angiol 21 (4): 360-6, 2002. Patients with clinical limb ischemia and nonhealing wounds at high risk of amputation can achieve complete wound healing and limb preservation by using an intermittent pneumatic compression device.
61. Morgan RH, Carolan G, Psaila JV, Gardner AMN, Fox RH and Woodcock JP: Arterial flow enhancement by impulse compression. Vasc Surg 25: 8-15, 1991. It is suggested that the hyperemic effect may be explained by the liberation of endothelial-derived relaxing factor (EDRF), a powerful relaxant of vascular smooth muscle, produced in response to sudden pressure changes ( hemodynamic shear stress) within the venous system.
62. Parmley WW, Chatterjee K, Charuzi Y, and Swan HJC: Hemodynamic effects of noninvasive systolic unloading (nitroprusside) and diastolic augmentation (external counterpulsation) in patients with acute myocardial infarction. Am J Cardiol 33: 819, 1974. Cardiac index rose 17%, peak diastolic blood pressure rose 20 mmHg and mean diastolic blood pressure rose 7 mmHg after external counterpulsation. Changes in pulse rate, systemic vascular resistance, right atrial pressure and pulmonary wedge pressure were not significant. Stroke work index rose in the patients who had had myocardial infarctions but not in controls.
63. Pfizenmaier DH 2nd, Kavros SJ, Liedl DA, Cooper LT: Use of intermittent pneumatic compression for treatment of upper extremity vascular ulcers. Angiology 56: 417-22, 2005. Intensive IPC pump use is feasible and associated with a high rate of healing in upper extremity ischemic ulcers.
64. Podrid PJ: Redefining the role of antiarrhythmic Drugs. New Engl J Med 340: 1910, 1999. He concludes pointing out that authors did not recommend the routine use of either sotalol or ibutilide, that the drugs should be used when nonpharmacologic methods fail, and that drug therapy is continuing to evolve. Comments: Commonly, we attempt to slow rapid atrial fibrillation with either or both digoxin and a beta-blocker to rates below 80. We have been pleased to find that a modest number of patients may convert to normal sinus rhythm during their boot therapy. It is possible that the improved hemodynamics described above (Dillon, Angiology 1998) play a role.
65. Ramaswami G, D’Ayala M, Hollier LH et al: Rapid foot and calf compression increases walking distance in patients with intermittent claudication: results of a randomized study. J Vasc Surg 41: 794-801, 2005. Intermittent pneumatic calf and foot compression (IPCFC) in initial claudication distance (ICD) and in absolute claudication distance (ACD). RESULTS: the percent change from baseline for ICD and ACD for each patient visit and the mean +/- standard deviation (SD), standard error (SE), and median were calculated for the control and treatment groups. The percent change from baseline measurement (mean +/- SD) for ICD and ACD in the control group at 4, 6, and 12 months were 2.2+/-18 and 2.3 +/- 18, 2.9 +/- 17 and 5.2 +/- 20, and 3.6 +/-18 and 5.8 +/-20, respectively. In contrast, the changes in ICD and ACD at 4,6,and 12 months in the tretment group were 137.1 +/-128 (P<.01)and 84.3 +/-82 (P<.01), 140.4 +/-127 (P<.01) and 96.4 +/-106 (P=.01), and 150.8 +/-124 (P<0.01), and 101.2 +/-104 (P<0.01), respectively. Although the ABI showed a slight increase in the treatment group, these differences were not statistically significant. CONCLUSIONS: The results of this pilot study shows that IPCFC improves walking distance in patients with stable intermittent claudication. A significant increase in ICD and ACD was seen at 4 and 6 months of treatment, respectively, and the improvement was sustained at one year. The combination of IPCFC with other treatment such as risk-factor modification and daily exercise may prove useful in patients with peripheral arterial occlusive disease. It may be a useful first line of therapy in patients with disabling claudication who are unfit for major reconstructive surgery. Improved walking on long-term follow-up and experience from different centers may establish a role for this treatment modality in the future.
66. Shechter M, Matetsky S, Feinberg MS et al: External counterpulsation therapy improves endothelial function in patients with refractory angina pectoris. J Am Coll Cardiol 42 : 2096-8, 2003. CONCLUSIONS: External counterpulsation significantly improved endothelial function in CAD patients with refractory angina pectoris, thereby suggesting that improved anginal symptoms may be the result of such a mechanism.
67. Schleicher SM and Milstein HJ: Treatment of pretibial mucinosis with gradient pneumatic compression. Arch Dermatol 130: 842-844, 1994. Authors successfully treat an 83 year old man with multiple-flesh-colored-erythematous indurated nodules and plaques over both anterior tibial areas. He also had non-pitting edema and a continuous drainage.
68. Silverglade A: Peripheral vascular disease: Diagnosis and treatment by passive vascular exercises. Arch Physical Therapy 21: 100, 1940. Describes success with suction pressure boot in the pre-antibiotic era.
69. Smith PC, Sarin S, Hasty J and Scurr JH: Sequential gradient pneumatic compression enhances venous ulcer healing: A randomized trial. Surgery 108: 871-875, 1990. The results indicate that sequential gradient compression is beneficial in the treatment of venous ulcers.
70. Solignac A, Ferguson RJ and Boourassa MG: External counterpulsation: coronary hemodynamics and use in treatment of patients with stable angina pectoris. Cath and Cardiovasc Diag 3: 37-45, 1977. Concluded: ECP of doubtful value in Rx of patients with stable angina.
71. Soran O, Kennard ED, Kfoury AG, Kelsey SF, IEPR Investigators: Two year clinical outcomes after enhanced external counterpulsation (EECP) therpy in patients with refractory angina pectoris and left ventricular dysfunction (report from the international EECP patient registry). Am J Cardiol 97(1): 17-20, 2006. In conclusion, for patients who have high-risk LV dysfunction, EECP offers an effective, durable therapeutic approach for refractory angina. Decreased angina and improvement in quality of life were maintained at 2 years, with modest repeat EECP and low major cardiovascular event rates.
72. Soroff HS, Hui J and Giron F: Current status of external counterpulsation. Critical care Clinics 2: 277-295, 1986. In summary, authors conclude improved treatments would include: 1, treatment area to include buttocks. 2, technique to include a negative pressure phase. 3, further investigation of graded sequential approach with negative phase. 4, treatment earlier in cardiogenic shock and for at least 4 hours in cardiogenic shock.
73. Steinberg J: Cardiosynchronus limb compression: effects on noninvasive vascular tests and clinical course of the ischemic limb. Angiology 43: 453-61, 1992. Cardiosynchronus limb compression (CSC). The study demonstrated that CSC treatments : 1, caused increased limb blood flow as determined by increased ankle/arm indices and hallux photoplethysmograph waveform amplitudes during treatments. 2, led in most cases to improvement in or resolution of the presenting ischemic problem (eg, ulcer, cellulitis, rest pain). 3, induced limb improvements that persist for up to 7 years. 4, caused no adverse side effects.
74. Stevenson LW: Inotropic therapy for heart failure. N Eng J Med 339: 1848-1850, 1998. In this editorial, Dr. Stevenson reviews the various inotropic agents and concludes: all increase mortality rates versus placebo. Digoxin, she points out has a neutral effect on mortality. Current approved therapy , she concludes consists of diuretics and angiotensin-converting enzyme (ACE) inhibitors. Comment: Circulator boot therapy has long been approved by the FDA in the treatment of congestive heart failure.
75. Topol EJ: Coronar-artery stents- gauging, gorging and gouping. N Engl J Med 339: 1702-1703, 1998. Cardiologists have mistakenly believed that stenting reduced the incidence of death and myocardial infarction. However, careful examination of the results of randomized trials comparing stenting with balloon angioplasty, including the trial by Erbel et al, shows an excess number of deaths and myocardial infarction among the patients assigned to stents. To date, the only clinical benefit that has been shown for stenting as compared with balloon angioplasty is a reduced need to target vessel revascularization. Unfortunately, in hospitals throughout the United States today, patients with lesions in small arteries, bifurcations and extensive, diffuse atherosclerotic disease, undergo stenting even though there are no data to support these applications. Patients with peripheral arterial occlusive disease are almost certain to have coronary disease. We find that it is not uncommon for them, even though asymptomatic, to find their way to the invasive cardiologist who may perform an angioplasty with or without stenting. Quite commonly the balloon impacts plaque into the origin of a small artery producing a small infarct, which in the belief that a larger infarct may have been prevented by the procedure, is not reported to the patient. ON occasion, the patient does not survive the procedure.
76. VAN BEMMELEN PS, MATTOS MA, FAUGHT WE, MANSOUR MA, BARMEIR LD, HODGSON KJ, RAMSEY DE, SUMNER DS: Augmentation of blood flow in limbs with occlusive arterial disease by intermittent calf compression. J Vasc Surg 19: 1052-8, 1994. Authors conclusions: An increased arteriovenous pressure gradient accounts for some but not all of the flow increase much of which must be attributed to transient vasodilatation. Because the increase in flow does not depend on an increased inflow pressureand was not adversely affected by a low resting ankle-brachial pressure index or a low toe-pressure. Intermittent external limb compression may deserve investigation as a possible adjunct to the nonoperative treatment of patients with severe arterial insufficiency.
77. Van Bemmelen PS, Gitlitz DB, et al: Limb salvage using high pressure intermittent compression arterial assist device in cases unsuitable for surgical revascularization. Arch Surg 136: 1280-5, 2001. CONCLUSIONS: Intermittent high pressure compression may allow limb salvage in patients with limb-threatening ischemia who are not candidates for revascularization. Further studies are warranted.
78. Vella A, Carlson LA, Blier B, Felty C, Kuiper JD and Rooke TW: Circulator boot therapy alters the natural history of ischemic limb ulceration. Vascular med 5: 21-25, 2000. (Mayo Clinic and Foundation, Rochester, MN). Circulator boot therapy is associated with improved outcomes in limb ulceration due to peripheral vascular disease. Complete ulcer healing as well as preservation of the affected limb can be achieved in most cases.
79. Waggoner PC: Mechanical interventions after acute myocardial infarction: Impact on patient outcome: Critical Care Nursing Clinical if N Am 4: 359-363, 1992. Listed possible outcomes for patients with acute myocardial infarction. INFARCT/NECROSIS PHASE- reduce infarct size, maintain adequate tissue perfusion, prevent complications, relieve pain and discomfort and prevent extension of infarction; and RECOVERY PHASE- promote maximum functional capacity, prevent further loss of functional myocardium and reduce risk factors. Criteria for total ventricular support: mean arterial pressure< 60 mmHg; left atrial and/or right atrial pressure <20 mmHg, urine output < 20 ml/hr; cardiac index < 2L/min/M2 with: (a) maximum pharmacological therapy, (b) optimal preload ( right atrial and left atrial pressures 15-20 mmHg) and (c) intraaortic balloon pump (if appropriate).
80. Werbel GB and Shybut GT: Acute compartment syndrome caused by malfunctioning pneumatic-compression boot, a case report. J Bone and Joint Surg 68-A: 1445-1446, 1986. Jobst boot valve failed allowing leg compression at 40 mmHg for 9 hours during surgery.
81. Werner D, Hui JC, Kropp J, Daniel WG: Pneumatic external counterpulsation – a therapy option in angina pectoris. Zeitschrift fur Kargiologie 87 suppl 2: 193-8, 1998. PECP is a virtually risk-free tretment option in patients suffering from angina despite medical and interventional treatment. Opening of collateral growth induced by external counterpulsation are discussed as the cause of clinical benefit.
82. Werner D, Michelson G et al: Changes in ocular blood flowvelocities during external counterpulsation in healthy volunteersand patients with atherosclerosis. Graefes Arch Clin Exp Ophtalmol 239: 599-602, 2001. CONCLUSION: No significant change of mean blood flow velocity in the ophthalmic artery was found in young healthy subjects. In elderly patients with atherosclerosis, ECP significantly increased blood flow velocity in the ophthalmic artery by 11.4%. This may indicate an ocular perfusion benefit in these patients as a result of ECP and could also explain the increase of perfusion found in patients with retinal ischemia after ECP.
83. Werner D, Michalk F, Hinz B, Werner U, Voigt JU, Daniel WG: Impact of enhanced external counterpulsation on peripheral circulation. Angiology 58: 185-190, 2007. The observed 4-fold increase of the peripheral pulsatility index supports the thesis of increase of shear-stress–related improvement of endothelial function during EECP.
84. Werner D, Michalk F et al: Accelerated reperfusion of poorly perfused retinal areas in central retinal artery occlusion and branch retinal artery occlusion after a short treatment with enhanced external counterpulsation. Retina 24 : 541-7, 2004. Acute central retinal artery occlusion (CRAO), branch retinal artery occlusion (BRAO). CONCLUSION: The current study suggests that EECP could be clinically useful and safe procedure in patients with CRAO or BRAO to accelerate recovery of perfusion in ischemic retinal areas.
85. William DO, Korr KS, Gewirtz H and Most AS: The effect of intraaortic balloon counterpulsation on regional myocardial blood flow and oxygen consumption in the presence of coronary artery stenosis in patients with unstable angina. Circulation 66: 593-597, 1982. Reduction of myocardial oxygen consumption was thought to be the most likely mechanism by which IAPB relieves myocardial ischemia in patients with unstable angina pectoris. Authors noted that coronary flow may go up in shock patients as it is diminished by the low aortic pressure.
86. Yu S, Da H and Zhen Z: External counterpulsation, Review Article. Chinese Med J 103 (9): 768-771, 1990. Angina pectoris : 1. Short term: sumptoms in 52.6% of 3218 cases significantly improved, 30.3% improved, 8 % no change and 0.2 % deteriorated. MORTALITY in angina patients: ECP vs placebo in 1st and 8th years: 4.9 vs 13.51 (1st year) and 7.69 vs 30.3 (8th year). TREATMENT OF ISCHEMIC CEREBRAL DISEASES: in small series ECP more effective than medication. OTHER APPLICATIONS: Effective in 87.2% of cases of sudden deafness. Effective in tretment of thrombus of the retinal artery, traumatic optic atrophy, and serous central retinopathy.
87. Zheng Z-s, Li T-m, Kambic H, Chen G-h, Yu L-q, Cai S-r, Zhan C-y, et al: Sequential external counterpulsation (SECP) in China. Trans Am Soc Artif Intern Organs 29: 599-603, 1983. 97% of 200 patients relieved with improved EKG in 63.8% and little relapse when Rx stopped ( 40 controls treated with Segontin had relief in 72.5% and improved EKGs in 40%, half relapsing after drug stopped). In 52 patients with an acute MI, 95.7% relieved of pain within a few hours and 5.8% dies vs mortality of 18.4% in controls. When the effects of SECP were evaluated with the mapping method, indicators of infarct size were found to increase in the control group and decrease in the SECP group.
