Deputy Director, National Heart and Lung Institute
Director, Fogerty International Health Center
From: Dr. Lowell T. Harmison
Division of Technological Application
National Heart and Lung Institute
Subject: Trip Report on Visit to the USSR Concerning Assisted Circulation and
Total Heart Replacement
The principal purpose of the visit was to determine the areas of work in assisted circulation, heart replacement and other
areas of research and investigation of direct relevance to the artificial heart.
The visiting team consisted of Dr. Louis Rakita, Cardiologist, Case Western Reserve, Dr. Clarence Dennis and Dr. Lowell T.
Harmison, National Heart and Lung Institute.
The program for the visit in the USSR was developed exclusively by the Russians with the principal coordinator being Dr. Valeriy
I. Shumakov, Professor of Surgery, Research Institute of Clinical and Experimental Surgery in Moscow. A copy of the agenda
for the period February 25 through March 4, 1973 is given in Attachment 1. It identifies the research institutes, clinics,
principal investigators and time spent at these institutions plus other information concerning the visit. The scientific institutions
and chief scientists visited were:
Research Institute of Clinical and Experimental Surgery, Moscow; Professor B. V. Petrovsky
Research Institute of Medical Instrumentation, USSR Ministry of Medical Industry; Dr. Michail Davidovich Pekarsky
Artificial Heart Laboratory of the Research Institute of Clinical and Experimental Surgery; Professor Valeriy I. Shumakov
Bakulev Institute of Cardiovascular Surgery, Moscow; Professor V. I. Burakovsky
Vishnevsky Institute of Surgery, Moscow; Professor A. A. Vishnevsky
Research Institute of Surgical Instruments and Devices, Moscow; Dr. Rustam I. Utjamishev
Pulmonology Institute, Leningrad; Professor Georgy A. Rusanov and Dr. Lydia P. Volkova
V. I. Kolesov's Clinic, Leningrad; Professors V. I. Kolesov and E. V. Kolesov
In each of these institutes and clinics we met the director and the principal staff. In the following section, I will attempt
to provide some detailed impressions and observations of the visit to Russia. It includes an overall summary and a discussion
of each institute visited.
Bearing in mind the limitations associated with: (1) the limited number of facilities visited, (2) the time available for
discussion within each, and (3) each of the areas, I would summarize my observations as follows:
A. The research and development efforts in circulatory assist and total heart replacement are mundane. They are at least five
years or more behind the efforts in this country. I saw no new avenues of research under study that have not been tried and
rejected here or are under current investigation. I consider the development and testing efforts we saw very pedestrian in
B. They are applying maximum effort to maintain awareness of U.S. efforts in both animal and clinical areas of study. This
was demonstrated in terms of the types of devices which have been adapted for clinical use from commercial lines in the United
States, the types of laboratory devices and techniques that we observed in both operative and postoperative procedures, the
brochures and catalogs of American-type equipment, etc.
C. No areas of research probing the frontiers of either animal or clinical arenas were presented to us. The level of sophistication
involved in the physical science and engineering research associated with the space program was not apparent in the biological
and medical programs observed.
D. Their concept of evolving new devices and techniques, however, appeared very interesting. For example, it involves: (1)
a medical research institute performing the basic research and establishing physiologic feasibi1ity, (2) physical science/engineering
institute developing prototypes for controlled laboratory and clinical evaluation, and (3) a subsequent institute for development
of the large number of devices and their distribution to other cities and states within the Socialist Republic. However, no
real evidence that the concept has worked was apparent outside of the development of the staple gun which is familiar to many.
The multiple kidney dialysis unit, however, may be the first unit coming through the system.
E. The medical care system seemed to exhibit little lost motion in terms of patient flow from the outlying districts to the
specialized clinics for study and treatment. Obviously, the quality of care delivered, its speed of application and overall
effectiveness could not be gauged in the short time available. Nevertheless, their approach within each of the clinics visited
seemed to be very direct and functional without a great deal of attention to peripheral matters.
F. Laboratory research seems to be well integrated with their clinical studies; however, the results of their laboratory investigations
were never really made apparent to us in terms of biological data.
G. The emphasis appeared in most cases to be on clinical medicine rather than research. This applies even in the clearly identified
H. The equipment, design of facilities, movement or flow of people, sterilization technique and general attention to detail
seemed to leave many areas for improvement.
I. The work presented to us in our visits to Moscow and Leningrad was behind the state-of-the-art. Specifically, we saw no
efforts toward noninvasive instrumentation and techniques for detection, diagnosing and monitoring disease, and no definitive
research in hematology, hemodynamics, blood materials interface and other critical parameters essential to effective circulatory
assist and total replacement research and development efforts.
J. The lack of open discussion on scientific questions concerning instruments, devices and techniques may have been due in
large partly to the important patent question. At several points in discussions at different institutes, the proprietary question
and patent activities were given as reasons for inability to discuss the area. In my view, this poses major questions and
areas of difficulty which must be properly explored before effective communications and interactions can be developed for
advancing this area of science. The concern stems not from the medical area but from the technologies involved because of
their influence on items of commerce, defense, etc. There are three critical areas: (1) it limits scientific exchange between
scientists (which we encountered); (2) it may significantly reduce incentives for participation on the part of the U.S. institutions
in the performance of R&D efforts; and (3) it can have a major impact on the development, marketing and distribution of
new medical instruments and devices throughout the United States. The reason for concern in this matter is that the Russians
may make minor modifications of U.S. technology and then secure or seek patent rights for such minor improvements in this
country as well as in other Western countries. American and Western European companies might then have difficulty marketing
products they have developed, even in their own country. It would appear that without effective exchange of ideas, this area
will remain extremely unclear and therefore reduce incentives for participation by many of our contract and grantees in this
kind of scientific exchange and have an impact as previously indicated on translating the fruits of research into tools of
medical care and items of commerce.
I have the distinct feeling that more information existed in the relevant areas of CAD and total replacement than we were
shown. It was also apparent that our visit was very carefully arranged by Dr. Shumakov; possibly it did not include other
laboratories and facilities or efforts that may be in direct competition scientifically with his laboratory and associates.
In my view, it is essential that the publications, questions to be answered, and other literature promised to us from the
various laboratories be obtained and analyzed before any avenues of exchange can be effectively developed. A suggested second
step beyond this might be a joint conference to present scientific material on relevant areas of circulatory assistance and
total heart replacement for review and analysis, assuming that papers for the conference could be provided and reviewed by
a joint editorial board prior to their acceptance for the meeting to insure some scientific meat in the papers to be presented.
I would not advise additional onsite visits until these two steps have been accomplished.
3. Discussion of Each Institution Visited.
A. Research Institute of Clinical and Experimental Surgery, Moscow.
This research institute is under the direction of Professor B. V. Petrovsky. The first part of our visit to this institute
was under the supervision of Dr. Shumakov, Professor of Surgery at the Institute and our principal host while in Russia. Dr.
Shumakov gave us a tour of his clinical activities which included a visit to his dialysis unit, organ preservation lab and
surgical facilities. The principal focus of Shumakov's activity in the clinical arena involves chronic uremic patients
with treatment following either transplantation or dialysis. He has performed 183 kidney transplants and an additional two
were performed during the day of our visit, one of which was performed by Dr. Shumakov. A few complications developed during
the procedure; however, it was performed satisfactorily with total time requirement of about five hours. The procedure was
relatively crude, e.g., the donor kidney had not been prepared until the recipient was ready to receive it. Instrumentation
was practically nonexisting in the operating room. According to our standards it would not be considered adequate. The dialysis
unit consisted of a six-bed unit with central washing of the perfusate and individual controls for each of the patients being
dialyzed. The type of dialyzing unit used is the Kiil unit. They have developed a solution for storing kidneys without perfusion
for up to 32 hours. They would give us no details or even discuss the solution.
Animal Laboratory of the Institute: We visited the facilities that Shumakov uses in his work; they included both circulatory
assist and total heart replacement experiments. The laboratory was adequately equipped with instrumentation, surgical facilities,
mock circulatory loop units, biochemistry labs and other supporting chemistry labs to make it a complete research facility.
Their experiments in the laboratory cover cardiac assistance through the heart-massage cup, the intra-aortic balloon, the
series left assist heart, i.e., left atrium to ascending or descending aorta, various types of cannulation techniques for
circulatory support, veno-venous and veno-arterio blood pumps of the pulsatile variety and partially implantable total heart
devices, i.e., pumping chambers in thorax with the control unit and drive system external to the animal. Their work included
both dog and calf species. A major percentage of their work has been in the area of circulatory assistance. The number of
experiments performed by the laboratory exceeds 700, with probably over 500 being devoted to circulatory assist and the other
experiments concerning various aspects of total circulation support and the artificial heart. The method of powering all of
their units was pneumatic, with control for assist-type devices principally being derived from the QRS complex. When asked
for specific information on method of control techniques for discrimination of arrhythmic signals and other parameters concerning
synchronization and their effect on cardiac support, the questions went unanswered. For control of the total heart, they are
developing an approach that utilizes stroke volume and aortic root stretch sensors and venous pressure for control. Again
we could elicit no scientific discussion on the system. We were told that it was still in the paper stage. In many cases,
the answer was that the appropriate person(s) to provide the answers were not present, or I got a lengthy discussion that
was a closed loop leading to no light on the question.
They showed us a variety of models of assist and total replacement hearts, most of which were copies of things that you could
see in ASAIO proceedings from 1960 to 1965. The types of valving used in their pumps were ball, flap or disc valves. We did
not see any valve research efforts. We were not shown any cardiovascular experiments or any real significant data from animal
studies. We did see a pump functioning on the mock loop, but in a very typical display fashion. Most of the laboratory was
idle during our visit. Possibly, this was arranged in order to have the people available for discussion; however, this objective
was not apparently accomplished. In summary, I think the laboratory might be considered typical of several in the United States.
It does have a large number of personnel; without a specific headcount I would gather at least 75 to 80 people are involved
in the animal research laboratories under Shumakov's direction in the area of assisted circulation and total heart replacement
B. Research Institute of Medical Instrumentation, USSR Ministry of Medical Industry, Moscow.
The stated mission of this institute was for the production of the specialized medical instrument on a research scale for
investigative purposes, not broad clinical uses. In essence, it was the pilot-type of research and development laboratory
in support of medical research in the USSR. They presented us a broad outline of their activities in the heart and pulmonary
area. The principal scientists making the presentations were Professors Kalantarov and Alexander Pistsov. The discussions
were very circumspect and peripheral in nature. When asked for more scientific detail in most areas, it simply was not forthcoming.
Again, the standard answer was people most familiar with the details of the research and development were not present or they
were tied up in an experiment. The scientists at this institute collaborate closely with the medical schools and hospitals
in the area and other cities to carry out their experiments on the prototype instrumentation. We did not see any research
in progress at the institution. We did see much work in the area of mathematical modeling and fabrication of limited quantity-type
units for both cardiovascular and pulmonary purposes. Their work included:
1. Pulsatile blood pump work with basic synchronization from the QRS complex with vacuum filling and without vacuum filling.
The types of pumps are very similar to what has been under investigation for the previous eight or ten years in the U.S.,
basically nothing new. They gave us only limited performance parameters from a scientific point of view concerning the pumps
and essentially no biological data on their performance. The materials of constructions included silicone, plexiglass, carbon
and different types of urethanes.
2. Their work also included significant efforts on respirators and heart-lung machine development. However, all of the developments
seen appeared to be within the state-of-the-art as we know it today.
3.They discussed the xenon injection techniques for evaluation of regional blood flow, including cerebral flow, but gave no
data to back up their statements concerning accuracy and repeatability. This work appeared to be valuable but we will await
review of requested reprints for any assessment.
4. They discussed a phonographic technique for assessing lung disease via application of an 80 Hz sound induction into the
lung and making recordings with microphones to assess shifts in both frequency and amplitude, to obtain information concerning
occlusions and other characteristics of the bronchi
and smaller airway passages throughout inspiration and expiration. Their research indicated that 80 Hz gave them more information
than frequencies on either side. This is something which we should look into further in the lung area.
5. They are developing muscle stimulators utilizing very high frequency (2000 hertz and above) to avoid pain. Again, no specific
data was presented to show the performance of these units.
6. They are developing an electronic sleep device to achieve deep sleep in the order of fifteen to thirty minutes. The device
consists of approximately ten sensors positioned at different locations on the head, yielding electrical impulses of five
millisecond duration at 100 cycles per second. No data were presented on this unit.
A number of other medical instruments were shown us. Literature on a variety of these units are in my file, should anyone
desire to have more specific information. However, they are in the Russian language.
C. Bakulev Institute of Cardiovascular Surgery, USSR Academy of Medical Science, Moscow.
We received a general tour of the institute and discussion on each of its major principal areas - vascular disease, acquired
heart disease and congenital heart disease. The institute had an area for performing assisted circulation; however, we received
no details on its use other than a brief discussion regarding its application in terms of support for open heart procedures.
They have also performed approximately forty coronary bypass procedures. However, when we asked about follow-up information
feeling of effectiveness, we received very little discussion. In essence, artereographic follow-up and careful analysis on
the patients appeared to be lacking. He clinical facilities appeared to be adequate with sufficient instrumentation and equipment
in the IC units for good care, including all of the necessary emergency equipment and supportive gas requirements. The intensive
care units were filled with postoperative patients, not MI patients. This Institute receives very few MI patients because
we were told they were shunted to other facilities.
D. A. V. Visnevsky Institute of Surgery, USSR Academy of Medical Science, Moscow.
We had a general tour of the institute with discussions on most of its major activities. This included a film of open heart
procedures, as performed in Russia, and their utilization of the heart-lung bypass machine; of a diagnostic program processed
by the computer for handling problem cases from outlying medical institutions and regions around the country; and of electrical
stimulators for bladder and intestine stimulation. The Vishnevsky Institute has a much newer facility than those we generally
visited on our tour. It was well equipped with six modern operating suites, which included TV monitoring of patients in both
intensive and general care units and the incorporation of a nighttime technique for observation of the IC units involving
the application of infrared light. The principal things of interest in this facility included a technique for measuring the
depth of anesthesia
by integrating the area under the EEG trace. I tried to explore this technique with them; however, it was unsuccessful because
the people who know about it were apparently not there. I do feel this is a very interesting concept that possibly needs further
study and evaluation here. The institution was using the xenon technique for regional and peripheral blood flow studies and
studies of cardiac output and pulmonary blood flow. In each of the major laboratories in the facility, computer terminals
exist for special calculations involving respiratory function and cardiac output and other parameters needed by the attending
staff. An area concentrated on by the people who presented our tour included the RF stimulation technique for control of bladder
and intestinal function. They have developed the RF technique for stimulation quite far, including proper placement of sensors
in order to yield normal control of the bladder. Basically, this resulted in the placing of the negative electrodes in the
neck of the bladder which afforded excellent control by the patient. The operating characteristics of their stimulator are
current, approximately five microamps, at a voltage of ten to sixteen volts with a frequency of fifteen to twenty hertz. The
stimulation threshold rises shortly after implantation; however, it stabilizes within the range indicated above within several
weeks. The RF stimulation technique is also used for intestinal disorders, such as ulcers, They find that ulcers will heal
within one month with application of the stimulation technique, versus one to two years without stimulation. The characteristics
of the stimulation pulse are the same as for the bladder. We asked about the number of patients that had been treated, but
it was unclear as to how large their data base was for making the assessment of more rapid healing.
This institute is, however, at the initial stage for application of the intra-aortic balloon. A few applications have been
made; however, no significant data were available nor were they able to discuss the specifics of the unit. They also maintained
an emergency cardiac unit involving the massage cup plus a variety of other emergency equipment, i.e., anesthesia, complete
bypass units, respirators, defribulators, etc., all in a room for immediate support of surgical and intensive care patients.
We received no assessment of their performance and results.
E. Research Institute of Surgical Instruments and Devices, USSR Ministry of Health, Moscow.
This institute is primarily involved in developing medical instruments for clinical application based on prototypes that have
proven satisfactory in early clinical trials. It also has the major responsibility for providing medical instruments and devices
to all Socialist countries. Several devices made by this institution are:
1. The Vessel Stapler: This instrument has undergone continuous development from its inception. Now, in a single operation
it can anastomose vessels of a diameter of 1.3 to 1.5 millimeters.
2. Dialysis Equipment: The units are now developed for multi-bed applications up to eight beds. The clinical dialyser is of
the Kiil-type unit.
3. External Massage Unit: An external massage defribulator unit, very similar to those in the United States.
4. Bypass Circulation Equipment: Extracorboreal circulation units with both roller- and pulsatile-type pumps for heart-lung
applications have been fabricated. This laboratory also fabricates and provides devices to Dr. Shumakov's laboratory.
Control units for the total heart replacement work are based on three parameters: (1) venous pressure, (2) stroke volume,
and (3) some measure of distensibility of the aortic root. They would provide no details on this when questioned.
5. MI Detectors: A clinical unit for determination of MI based on the EKG; however, in a long series of questions we were
unable to acquire any information about the system. They indicated that there would be some publications in the future which
they would send to us. We asked them about the accuracy of the unit; they felt that 92 to 96 percent of the diagnosed cases
of MI were picked up by this machine technique and that there existed only a two percent false positive and four to eight
percent false negative indications. This all seemed a bit highly quantitative to us in the absence of no answers to our series
of questions. I asked them if they have an operator's manual for the device since they have a number of units already
in operation. They said, "No, it has not been assembled yet". The director, Rustam I. Utjamishev, indicated that
this unit would be installed in the very near future in all cities with populations above 500,000.
The facilities within this institute seemed to be similar to those that we would find in various industrial laboratories throughout
the United States. They had a well-equipped computer calculation center, electronics fabrication and test area, mechanical
workshop area and well-equipped monitoring and test laboratories. They seemed to have a large activity in integrated circuits
and other smaller electronic components necessary for miniaturization and routine production of complex electronic systems.
On their shelves, I noticed laboratory books and catalogs from such companies as Tectronics, Beckman and Hewlett-Packard.
They demonstrated to us an eight-patient dialysis unit with central automatic controls for a single operator that would permit
monitoring each of the patients and the appropriate mixing and control of all parameters dealing with the eight beds, individually
or collectively. The entire system, they pointed out, could be set up and functioning within three hours after arriving at
Although our visit was very interesting in terms of show and tell, we were really unable to determine any real basic scientific
information. They would not give us information on their systems, indicating that the publications were yet to be put together.
F. Pulmonology Institute, USSR Ministry of Health, Leningrad.
The Pulmonology Institute coordinates all respiratory research and clinical studies in the USSR. The activities of the institute
in Leningrad are directed to respiratory research on both the animal and clinical levels with an active interest in lung transplantation.
It also has a significant team involved in circulatory assist and support efforts. In addition to these activities, it had
the normal complement of backup laboratories and facilities that most large medical facilities have.
In the circulatory assist area, they have devoted most of their attention to short-term cardiovascular support approaches
involving left-heart bypass and the intra-aortic balloon. None of their work has proceeded to the clinical level; they have
carried out only limited animal studies with the intra-aortic balloon. They could not present any biological data concerning
reduction in cardiac work, tissue damage, desired settings for synchronization and other parameters essential. This would
appear to indicate that a significant base of research was not present. They have, however, tried the grandstand approach
and have maintained an intra-aortic balloon in an animal for ten weeks without clotting, but they have only done one procedure
in this time frame. When asked if they have established a protocol for patient selection and for application of the intra-aortic
balloon, they indicated that none had been established. They felt that its principal use would be for the postsurgical patient.
They are using carbon dioxide as their working gas with a polyvinyl type of balloon material coated with heparin, They indicated
familiarity with the GBH approach; however, they did not elaborate when questioned about other techniques of surface coating
or their results.
They have implanted a number of left-ventricular bypass pumps which have been used satisfactorily for periods of three weeks
with up to sixty percent of cardiac output being taken by the pump and some lowering of left-ventricular pressure. The specific
details on degree of reduction of cardiac work and left-ventricular pressure were not presented. When asked if they were considering
cardiac models involving deteriorated function, they indicated they have not given any thought to these types of studies in
order to assess the degree of cardiac assistance and true benefit to be gained by the left-heart bypass pump. They have developed
a wide variety of designs with different inflow/outflow characteristics, including different types of valves in the various
The laboratory also has a very active program in cardiac pacemaker development and clinical application. They did not indicate
to us the number of pacemakers implanted; however, the number must exceed several hundred based on the patients and the type
of development problems that they have considered. The laboratory has also developed a variety of support equipment for their
lung-transplantation work. We asked them to provide us some literature which they indicated was available on the various types
of lung preservation devices used in both autotransplant and homotransplant work. The laboratory has developed and is using,
on both the clinical and laboratory level, a variety of pulmonary function equipment. In several cases, though, it appears
that they have simply developed a Russian version of American equipment. Their research work has been limited to invasive
techniques of PO2 and C02 monitoring. They indicated, however, that noninvasive techniques of monitoring were being developed
In terms of other hospitals visited, the Pulmonology Institute seemed to be very well organized and carried forth various
echelons of intensive care treatment down to the general ward.
G. V. I. Kolesov Clinic - First Leningrad Medical Institute, Leningrad.
Professors V. I. Kolesov and E. V. Kolesov gave us a tour of the hospital facility. The principal emphasis of the institute
is on coronary surgery and vascular surgery. Professor V. I. Kolesov initiated the internal-mammary to coronary-artery surgery
successfully in 1964. They indicated that they see approximately eighty percent of coronary-artery disease involving the right
and left vessel and only approximately twenty percent involving the circumflex. They perform their procedures without bypass
circulation except for procedures involving the circumflex. This is similar to several facilities in the United States. Based
on the expertise that they have developed in using the stapler, they feel the end-to-end anastomosis is much better than end-to-side
technique. They routinely make end-to-end anastomosis on diameters of approximately 1.3 millimeters. They have performed roughly
a hundred coronary bypass procedures. Obviously, they felt very strongly about the procedure. When asked about follow-up studies
on these patients, we found that only fifteen percent had been restudied and out of the fifteen percent, ten percent had been
bad in terms of occlusion and five percent had remained batent. After finding out this information, I was not sure whether
they were on firm ground concerning their strong interest in coronary bypass surgery; however, they indicated that they only
do the follow-up on the severe patients because most will not permit effective restudy. I think the question still remains:
is the patient alive because of the procedure, or would he be alive and in the same state without the procedure?
The laboratory has developed a rather elaborate EKG system for assessment of MI. They have a locus of points involving the
111 leads from which they feel they can determine, with approximately ninety-four percent accuracy, the state of the myocardial
infarcts. They, however, admit limitations regarding posterior-wall infarcts. They have not developed nor or they applying
vectoscardiography. In general, this institute seemed to be primarily devoted to coronary surgery with much less attention
to other areas of cardiac and vascular surgery. Their facilities were on a par with other Russian facilities. They seemed
to have a greater awareness of cardiac and cardiovascular surgery in the United States than other laboratories visited.