Prevention of Post-operative Thrombeomolism
by Negative Air Ionization in a Double-blind Study

E. Merimsky*, Y. I. Litmanovitch** and F. G. Sulman***

* Department of Urology, Ichilov University Hospital, Tel Aviv

** Vascular Clinic, Hadassah University Hospital and Medical Centre, Tel Aviv

*** Bioclimatology Unit of the Rothschild-Hadassah University Medical Centre, Jerusalem, Israel

This research was made possible by a generous grant from Mr. and Mrs. Herman Lane N.Y. and the Felton International Inc. N.Y.

ABSTRACT

A new method for avoiding post-operative thromboembolism has been tried, employing negative air ionization around the clock for an average period of 10 days during which 228 patients were hospitalized after major urologic surgery. The patients stayed in two rooms, 5 x 5m in size in which 4 ionizing apparatuses each had been installed. This allowed every patient to lie at a distance of 2m from a "Modulion"R ionizer emitting an average of 1 x 104 negative ions/cm3 air. In the six control rooms, 1,232 post-operative cases were hospitalized without ionization. Other treatment in all rooms was identical, avoiding anticoagulants.

In the 228 post-operative patients exposed to negative air ionization there occurred only one case of thromboembolism during an observation period of 28 months (0.04%), whereas in the 1,232 patients in the six control rooms there were 12 (1%) cases of thromboembolism which were then given standard treatment with anticoagulants: 3 of them died. The percentage of post-operative thromboembolism (1%) corresponded well to the average number of thromboembolism encountered in the rest of the hospital and to other hospitals in the country which did not use air ionization. Thus it appears that negative ionization can replace the risky prophylactic use of anticoagulants after operations.

INTRODUCTION

Deep venous thrombosis (DVT) and pulmonary embolism (PE) have become an increasingly important cause of disability and death during the last 50 years, especially in hospitalized patients (Kakkar, 1977a). Their importance to our society has to be judged by their incidence and effect on mortality and morbidity. Fatal embolism has been estimated at more than 20,000 cases annually in England and Wales (Kakkar, 1977b) and 50,000 cases annually in the United States (Hume et al., 1970). Pharmacological methods are quite effective in preventing deep vein thrombosis and pulmonary embolism, but fatal cases can still happen, according to different author, varying between 0.09 and 3% and even 15% in non fatal cases (Brown, 1977, Kass et al., 1978, Kakkar et al., 1975, Williams, 1971). Apart from the immediate risk to life, one must also consider the late sequels of this disease - the postphlebitic syndrome (phleboedema, chronic venous insufficiency, varicose veins, ulceration and induration) - which represent on equally distressing situation (Kurz et al, 1978). The urgency of the physician's concern with thromboembolism clearly lies in his inability to diagnose the condition accurately at an early stage when treatment can be effective. In almost half the patients, the thrombotic process is clinically silent, or the diversity of its symptoms is open to misinterpretation, Thus, fatal embolism may be the first symptom of DVT and PE.

It should be stressed at the outset that thrombosis is often the result of multiple factors, such as blood changes which predispose to thrombosis or trigger thrombus formation, i.e. alterations in the properties of platelets and of the components of the coagulation and fibrinolytic systems, furthermore, changes in the vessel wall are directly redated to coagulation and fibrinolysis, mainly platelet adhesiveness and aggregation. Processes associated with tissue damage (operation, burns, fractures, cancer) leading to an increased platelet adhesiveness or increased platelet coagulant activity, or both, initiate the formation of platelet thrombi. Certain patients such as those undergoing open prostatectomy or total hip replacement, are a high risk for thromboembolism and cannot be protected by prophylactic heparinisation (West et al., 1979). The final outcome in such cases is determined by the balance between thrombogenic and fibrolytic mechanisms, vascular injury and reactions of the platelets being the main contributory causes of thrombosis (Nilsson, 1977).

Patients with pulmonary embolism often have reduced arterial oxygen tension and this has been found to be the most consistent non specific laboratory finding. In the present study we have therefore tried to overcome the problem of reduced arterial oxygen tensions and doubtful prophylaxis by exposing post-operative patients to permanent negative air ionization which has been shown to activate oxygen tension and to convey a negative charge on the platelet membrane - thus preventing platelet aggregation (Sulman, 1976).

MATERIAL AND METHODS

Air Ionization

IONISING APPARATUS. - Negative ions were generated by the Modulion (R) of Amcor-Amron (Herzliya, Israel) which contains four ionising needles, each with a - 5,000 V charge (Fig.1). They produce corona discharges each emitting 2.5 x 1011 ions/s/mm3. As a Modulion can be used at a distance of 1-2m, the actual ion density reaching a patient is 2.5 x 105 - 2.5 x 104 ions/cm3/s. The apparatus' specifications are: 220/240 V, 50/60Hz. A control neon light built into the on/off switch flashes to indicate working conditions. The electrical field is 5,000 V DC, and the short circuit at ionization needles lower than 0.1mA. The 4 needles can be touched without receiving any unpleasant electrical discharge as the short circuit current on the high voltage side is limited to more 0.1mA. Power consumption is 2 W only. Dimensions: length - 14.5cm, width - 9.5cm and height - 7.5cm. Production of ozone and nitrous oxides is reduced to a minimum; at a distance of 10cm they could not be traced by 10/a Draeger Detection Tubes. Electrically charged aerosols have not been encountered. The casing of the Modulion is grounded which guarantees a stable and continuous ion flux. Design is according to international and European safety standards (VDE, SEV, IEC).

Normal Effects of Air Ions

Air ions are taken up by the respiratory tract and part of them reach the lungs. As they are mostly ionized oxygen and water aerosols they are taken up by the erythrocytes and thrombocytes at the alveole site together with normal oxygen and water. Positive air ions release serotonin from the thrombocytes (Tal et al., 1976), negative-ones counter this effect (Sulman et al., 1975), and, moreover, can inhibit platelet aggregation (Sulman, 1980).

Additional Effects of Air Ionization

A. Anti-Pollutant Effect

The room subjected to negative air ionization profited from a low bacterial count which amounted to 70% less than in control room (Sulman et al., 1974).

B. Anti-Serotonin Effect

Patients in the ionized rooms profited from the absence of weather-borne serotonin release with all its adverse sufferings (Sulman et al., 1977).

C. Dust Precipitation

The ionized rooms were freed from dust by the ionising apparatuses (Sulman et al., 1974). The was an advantage to the patients, yet it needed special arrangement in the immediate vicinity of the apparatuses which had to be protected by special paper on which the precipitated dust settled. The paper sheets were changed whenever required. In addition, the small apparatuses were mounted on a black rod.

Subjects and Design

The ionising apparatuses were installed in two rooms of the ward; the other six rooms contained dummy apparatuses. The patients, nurses and assistants of the ward were not aware of the trial and regarded the apparatuses as "electrical air conditioners". In each of the two ionized rooms 5 patients after major urologic surgery were accommodated (Table 2). the average stay of a patient in one of the ionized rooms was 10 days. During 28 months, 228 patients had profited from the negative air ionization, each one exposed to it 24 hours around the clock at a distance of about 2m. Ventilation of the two rooms was allowed at the customary level of the hospital.

In an earlier paper we showed that permanent ionization does not produce any harmful effect on well-being, routine blood and urine tests, EEG or ECG (Sulman et al., 1978). During the 28 months of observation 1,232 control patients after major urological operations had similarly spent an average of 10 days in six non-ionized rooms of the ward with dummy ionizer's. There was also an unintended "cross over" trial because, in the meantime, the ward was completely refurbished, which necessitated transfer of the "ionized" patients to other "ionized" rooms for 3 weeks.

To allow a clean assessment of the anti-thromboembolism effect, none of the patients in the ward received any prophylactic drug treatment which was only given when a case of thromboembolism appeared. Patients got up as a rule two days after the operation. During hospitalization regular blood and urine tests were used to supervise the patients' health and impending thromboembolism.

The "double blind" trial went on for 28 months, and is continuing now as an open trial. There was 1,460 admissions to the ward in that period, of which 228 were put at random into the two "ionized" room, 202 males and 26 females. Ages of the male patients varied from 14 to 88 years, ages of the female ones - from 29 - 75 years (Table 1).

The diagnosis and operations of the 228 patients in the "ionized" rooms are summarized in Table 2.

RESULTS

In the six non-ionized rooms there occurred during the 28 months of observation, 5 cases of deep vein thrombosis, 4 cases of pulmonary embolism and 3 cases of fatal pulmonary embolism, i.e. 12 cases of thromboembolism out of 1,460 admissions = 1% (Table 3).

In the ionized rooms there was only one case of deep vein thrombosis in a woman aged 67 who had undergone multiple operations on her right kidney and was hospitalized for 67 days. Her thrombosis was slight and lasted only a few days. Thus thromboembolism in the two "ionized rooms" amounted to 0.04% (P ,0.005).

Selected case histories

It would be interesting to note some exceptional cases which strengthened the case for the "ionized" rooms.

A woman, aged 50, arrived in our "non-ionized" ward after a gynecological operation and developed a deep vein thrombosis. She was then put in an "ionized" room. the thrombosis subsided and, in spite of further operations, there was no recurrence.

A man, aged 68, with a history of recurrent pulmonary embolism in the past was put in an "ionized" room and was operated on his prostate. There was not thrombosis or any sign of pulmonary embolism.

A man, aged 68, was admitted to the cardiac ward because of paroxysmal tachycardia. He was transferred to us for prostatectomy and put into an "ionized" room. He was discharged on the tenth post-operative day in good condition. The following day he was readmitted to the intensive care unit and died there of myocardial infarction.

DISCUSSION

As post-operative thromboembolism is mainly due to platelet aggregation, the mechanism of its prevention should be sought in the negative charge conveyed to the blood platelets by negative air ionization, since negatively charged particles do not tend to agglomerate (Sulman, 1980). Likewise, it has been claimed that the glucoproteids which cost the cell membranes of all blood cells prevent agglomeration by virtue of their negative charge.

Thromboembolism may appear in man like an epidemic on special days. It affects patients after operations especially in urologic and orthopaedic departments, or those suffering from varicose veins, phlebectasias, heart infarcts, cardiac insufficiency, arteriectasias, arterial occlusion and polycythyemia vera. Its correlation to weather changes has often been described (Feiman, 1965). Our research has shown that positive air ionization indeed provokes neurohormonal changes, especially serotonin release, which may precipitate thromboembolism (Sulman, 1977).

Recently we have extended these studies to atmospheric (electro-magnetic waves), showing that they affect serotonin release just like air ionization (Sulman et al., 1977). Thus it appears that the "epidemic" occurrence of thromboembolism on days of high positive electric air charges is produced by incoming weather fonts. It is a phenomenon which can be avoided by collaboration between surgeons and meteorologists. In South Germany, operations are not carried out on Foehn days because of the risk of thromboembolism caused by Foehn ionizations and sferics. Combating the menace by suitable neutralization of the ambient air is presently being studied by us, as negative electrical D.C. field combined with negative ionization may provide the cure. The problem aroused much interest in Germany when E. Rehn (1970) published his observations on the abolition of thromboembolism in an area (Kahlenberg) rich in negative ions and the return of thromboembolism in his modern hospital in Freiburg when the air was deprived of its ionization (Kahlenberg Factor). Rehn's observations did not receive the attention they deserved because they were published in the German language. 20

The fact that negative air ionization over 3-6 hours did not influence blood chemical components is noteworthy, however more study should be devoted to this finding using negative ionization for 24 hours, a period which has been shown by us to be free of harmful side effects (Sulman et al., 1978). Russian investigators cited in a NASA report (1966) claimed that negative air ions may cause a decrease in elevated blood cholesterol - a finding not yet closely studied.

The fact that negative air ionization prevents thromboembolism cannot be denied, yet its exact mechanism needs more research on membrane reactions which has now been inaugurated.

REFERENCES

1. BROWSE, K.L. (1977): The prevention of deep vein thrombosis and pulmonary embolism by pharmacological methods. Triangle, 16:29-32.
2. FREIMAN, D.G., SUYEMOTO, J. and WESSLER, S. (1965): Frequency of pulmonary thromboembolism in man. New Engl.J.Med., 272:1278-1280.
3. HUME, M., SEVITT, S. and THOMAS, D.P. (1970): Venous thrombosis and pulmonary embolism. Harvard Union Press Cambridge, Mass. p.3
4. KAKKAR, V.V. (1977a): Prevention of fatal post-operative pulmonary embolism. Triangle, 16:63-67.
5. KAKKAR, V.V. (1977b): Diagnosis of deep vein thrombosis and pulmonary embolism. Triangle 16:1-9.
6. KAKKAR, V.V., CORRIGAN, T.P. and POSSARD, D.P. (1975): Prevention of fatal post-operative pulmonary embolism by low doses of heparin. Lancet. 2:45-51.
7. KASS, E.J., SONDA, P., GERSHON, C. and FISCHER, C.P. (1978): The use of prophylactic low dose heparin in T.U.R. of the prostate. J.Urol., 120:186-187.
8. MURZ, W., WITTLINGER, G., LITMANOVITCH, Y.I., ROMANOFF, H., PFEIFER, Y., TAL, E. and SULMAN, P.G. (1978): Effect of manual lymph drainage massage on urinary excretion of neurohormones and minerals in chronic lymphedema. Angiology, 29:764-772.
9. NILSON, I.M. (1977): Coagulation, fibrinolysis and venous thrombosis. Triangle, 16:19-27.
10. REHN, E. (1970): Die Blutgerinnung und ihre Stoerungen - der Kahlenberg Faktor, W. Spitzner Pharm Publ. Ettlingen 1970, ppp 1-10.
11. SULMAN, F.G. (1976): Health, weather and climate. Monograph, Karger Publ. Basel, 160 pp.
12. SULMAN, F.G. (1980): The effect of air ionization, electric fields, atmospherics and other electric phenomena on man and animal. Monograph, Ch. C. Thomas Publ. Springfield III. 400 pp.
13. SULMAN, F.G., LEVY, D., PFEIFER, Y., SUPERSTINE, E. and TAL, E. (1975): Effect of the sharav and bora on urinary neurohormone excretion in 500 weather-sensitive females. Int.J.Biometeor., 19:202-209.
14. SULMAN, F.G., PFEIFER, Y., SHALITA, B. and TAL, E. (1974): Air Sterilisation: influence of negative ionization on bacterial counts on agar plates exposed to air. Int.Res.Comm.Syst., 2:1452.
15. SULMAN, F.G., PFEIFER, Y., LEVY, D., LUNKAN, L. and SUPERSTINE, E. (1977): Human sensitivity and atmospheric electricity. Israel Meteorological Research Papers, Steinitz Memorial Volume, 1:42-63.
16. SULMAN, F.G., LEVY, D., LUNKAN, L., PFEIFER, Y. and TAL, E. (1978): Absence of harmful effects of protracted negative air ionization. Internat.J.Biometeor., 22:53
17. TAL, E., PFEIFER, Y. and SULMAN, F.G. (1976): Effect of air ionization on blood serotonin in vitro. Experientia, 32:326-327.
18. WEST, B., GARRISON, R.N. and FLINT, L.M. Jr. (1979): Effects of concurrent seosis with clinically significant pulmonary embolic disease. Am.J.Surg., 137:358-361.
19. WILLIAMS, H.T. (1971): Prevention of post-operative deep vein thrombosis with preoperative subcutaneous heparin. Lancet, 2:950-952.

Age-Years	Male	Female
Under 50	14	3
50-60	25	8
60-70	79	13
70-80	72	2
Over 80	12	0
Total	202	26

Diagnosis and Operation	15	10
Pyelo-uretro-lithotomy	4	7
Nephrectomy	17	4
Bladder Tumor	0	3
Stress incontinence	127	0
Prostatectomy	39	2
Miscellaneous
Total	202	26

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