History of Pacemakers

 

1700s

 

De facto cardiac electrostimulation began in the mid-eighteenth century with the use of currents from the Leyden jar or Voltaic Pile (Allessandra Volta, 1799) to stimulate cardiac nerves and muscles in animals and to attempt resuscitation of intact dead animals.[6] Dr. William Hawes in London established The Humane Society of London in 1774 AD - A fraternity devoted to salvaging persons seemingly dead - motivated by similar such society in Paris. Later on it became The Royal Humane Society of London. Squires, Henley and Fothergill suggested Electrostimulation for resuscitation in a number of communications to the Society between 1774 and 1748.[7] Such an incidence is described by Charles Kite in his “An Essay upon the Recovery of the Apparently Dead.” (London, 1788) The 3-year old child was taken up for dead after falling out of a window. An “apothecary” was sent for, who could nothing; then electrical resuscitation by an electrostatic generator with a Leyden jar capacitor was used. (Fig.1) Squires described, 

“With the consent of the parents, very humanely tried the effects of electricity. Twenty minutes had at least elapsed before I could apply the shock, which I gave to various, part of the body without any apparent success; but at length, on transmitting a few shocks through thorax, I perceived a small pulsation; soon after that child began to breath, through with great difficulty. In about 10 minutes she vomited. A kind of stupor remained for some days, but the child was restored to perfect health and spirits in about a week.”[8] 

Charles Kite commented on this, 

“Do (these incidences) not plainly point out that electricity is the most powerful stimulus we can apply, and we not justified in assuming, that if it is able so powerfully to excite the action of the external muscles, that it will be capable of reproducing the motion of the heart which is infinitely more irritable, and by that means accomplish our great desideratum, the renewal of the circulation.”8 

However, it is noteworthy that we have almost matching description of resuscitation by electricity, this time by two Danish Scientist Herboldt and Rasn (1796) in their small booklet “Life saving measures for drowning persons and information of the best means by which they can be brought back to life.”[9]

 

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In 1802, Nysten used a human cadaver shortly following death by execution to demonstrate that the ability to reactivate the heart electrically was lost earlier for the left ventricle, later for the right ventricle, still later for the left atrium and last for right atrium.12 Later in the nineteenth century, Walshe (1862) and Duchenne (1870) advocated electrostimulation for cardiac standstill.[13],[14] During the same period, Althaus (1864) reported successful resuscitation of cardiac arrest victims by electrical currents applied through transthoracic needle.[15]

Dr.DeSanctis used “Re-animation Chair.”(Fig.2) as described by Richmond Reece in his The Medical Guide (1820). It had 3 pertinent features: a bellows to give forced ventilation, a metallic tube to be inserted into the esophagus and a voltaic pile attached at one pole to the esophageal tube and at the other to an electrode. The electrode was to be successively touched to “the regions of the heart, the diaphragm and the stomach…”[10] These reports may have lead John Hunter to recommend in 1776 that electrostimulation be tried as the as the resort in the resuscitation of drawing victims.[11]

 

 

By the early 1800s, there appeared a renewal of interest in acupuncture in Europe that had been introduced into Europe in the second half of the eighteenth century by Jesuit missionaries. In 1825, Sarlandie`re was the first to apply an electric (galvanic) current to thin metal needle electrodes (derived from acupuncture needles) thus creating electropuncture for the application of current to specific points on or in the body. Electropuncture soon became the accepted method of stimulating muscles, nerves, or organs beneath the skin . Electropuncture of the heart was first attempted by Krimer in 1828 without recorded success.

 

 

 

This technique was then abandoned for several decades. Meanwhile, W. Morton successfully introduced the use of ether as an anesthetic in 1846. Eventually, chloroform was found to be more suitable although cardiac arrest was a frequent complication of chloroform anesthesia in those early days. In 1871, Steiner overanesthetized horses, dogs, cats, and rabbits to produce cardiac arrest. He reported successfully applying an intermittent galvanic current to a percutaneous needle in the heart to evoke rhythmic contractions. Terms such as galvano and farado puncture soon started to appear in the literature .

 

In 1882, Von Ziemssen described a case of a 42-year-old lady named Catherina Sarafin who had a huge defect in the anterior left chest wall following resection of an enchondroma. The heart was covered by a thin layer of skin and was visible and palpable. Von Ziemssen noted that application of electrodes to the heart resulted in rhythmic stimulation only it the rate of stimulation was greater than that of the spontaneous heart rate. Slower stimulation produced erratic and sometimes slower heart rate. He also noted while placing his electrodes that the most sensitive area for stimulation was in the region of atrioventricular groove. [16] Interestingly this observation was made more than a decade before the description by Kent and His of the location of the atrioventricular node and bundle of His, respectively [17],[18]

In 1899, Prevost and Battelli demonstrated that electrical currents could cause ventricular fibrillation that often could be reversed by another powerful stimulus of either alternating or direct current.[19] Robinvitch in a series of reports from 1907 through 1909 confirmed this work and designed the first portable electrical resuscitative apparatus for ambulances.[20] MacWilliam, in many publications beginning in 1899 and extending to World War I, further elucidated the pathophysiology of ventricular fibrillation and described deterioration of cardiac pump function by tachyarrhythmias as well as bradarrythmias. [21]

Interestingly, the experimental and clinical experiences just described did not lead to immediate clinical trials of either cardiac pacing or electrical defibrillation. It was not until the efforts of Kounwenhowen (1932) and Beck (1947) that electrical defibrillation became widely used clinically.[22],[23] Studies in Europe by Marmrostein in 1927, using both transvenous and transthoracic electrodes to pace right atrium, right ventricle and left ventricle in dogs were essentially unnoticed in United States.24 This is evident from the reports in 1950 by Wilfred Bigelow, John A. Callaghan and Jack Hopps who independently described similar studies using transcutaneous electrodes to pace right atrium of dogs.[25] In 1949 during an experimental operation, a dog’s heart suddenly stopped at 21 ºC. “Out of interest and desperation,” recalls Dr.Bigelow, “I gave the left ventricle a good poke with a probe I was holding.”[25]All the four chambers of heart responded to it and further pokes clearly indicated that the heart was beating normally with good blood pressure. He immediately discussed it with Dr. Callaghan. Using dogs and rabbits, they again collected the data, studying the most effective and safe electric current and made movies of their key experiments to present before the Annual Surgical Congress of the American College of Surgeon’s meeting at Boston in October 1950. As Dr.Callaghan had done a “Lion’s share of work, particularly in the normal body temperature studies, “he made a ten minutes presentation.” Which was one of the scientific highlights of the day with great interest from the media.”[25] chuckles Dr.Bigelow. Co-incidentally their Co-worker Jack Hopps also later became a pacemaker recipient.

 

Electrical Stimulation of the Heart in Man by McWilliam – 1889

 

“The electrodes should be of considerable extent (for example, large sponge electrodes), and they and the skin should be well moistened with salt solution. The shocks employed should be strong, sufficient to excite powerful contraction in the voluntary muscles. Such a method, it seems to me, is the only rational and effective one for stimulating by direct means the action of a heart which has been suddenly enfeebled or arrested in diastole by causes of a temporary and transient character.”

 

 

 

McWilliam JA. Electrical stimulation of the heart in man. Brit Med J 1889;1:348-350.

 

 

 

Hyman Pacemaker

 

 

i. A small source of electric current, i.e. a common flashlight battery.

ii. An interrupter mechanism

iii. A timing device

iv. A method of regulating the duration of the injected current; and 

v. A suitable insulated needle to carry the current only to the right atrium of heart.

The instrument would, of course be easily portable and small enough to fit into a doctor’s bag.

The next 10 months were devoted to the assembly of such an apparatus…

By March 1, 1932 the artificial pacemaker has been used 43 times with a successful outcome in 14 cases.”[27]

 

The Hyman II Pacemaker

 

Siemens had determined that the pacemaker would not accomplish its intended function and that all actual models built had been destroyed during World War II. Surprisingly, a copy of Popular Science of October 1933 was found by chance, containing a single page article concerning the Hyman pacemaker with a photograph of Hyman's engineer brother, Charles, "resuscitating" a young man. In the background is the pacemaker thought to have been manufactured only years later.

From this article the date of manufacture must have been sometime during 1932-1933. The one other photograph extant is so clear that the labels on the dials can be read and interpreted as they were in an article about the reconstruction of the Hyman I pacemaker by the NASPE history project (Furman S, Jeffrey K, Szarka G. The Mysterious Fate of Hyman's Pacemaker. PACE 2001;24:1126-1137). With the knowledge gained from the reconstruction of the earlier device and the information concerning the function of each of the dials in the "orphan" photograph, the second device was also reconstructed as a working model. Unlike the earlier model which is hardly portable, weighing XX kilograms, the "portable Hyman II weighs YY kilograms, has a carrying handle and was intended to be brought to the site of use. The size of the device was estimated from the size of the handle, obviously intended to be operated by a human hand.

Both models are "working" in the sense that movable parts do move and for the Hyman II the small electrical output Hyman intended, incapable of causing a cardiac response, is emitted. From analysis of the electrical outputs of both Hyman devices it should not be expected that either would have been capable of resuscitating any asystolic mammalian or human heart.

The photograph shown is the original and may be compared with the reconstructed device. Many years later, after the invention of pacing, as it is known today, Albert S. Hyman was interviewed by historian David Schechter and quoted in his book (Schechter DC. Exploring the Origins of Electrical Cardiac Stimulation. Medtronic, Minneapolis, MN 1983). Hyman claimed to have resuscitated a patient in complete heart block with his "pacemaker" during his (Hyman's known) service in the U. S. Navy Medical Corps during the Second World War. None of those whom he stated witnessed the event ever mentioned it. The event is not otherwise recorded in the medical literature and no one remains alive. No records seem to exist.

Both these devices are the first known to bear the name artificial pacemaker and to have been specifically built and designed for cardiac resuscitation during asystole.

 

 

 

Beck Defibrillator

 

If ventricular fibrillation develops in hearts that are relatively normal, especially during operations, defibrillation may be life saving. During the period before regular rhythm is restored the heart must be exposed and rhythmically massaged in the interval. The method consists of the injection of 5cc. of 2 per cent procaine hydrochloride into the right side of the heart followed by a brief period of cardiac massage to distribute the drug throughout the myocardial bed. The heart is then placed between two large electrodes and ordinary 110 volt alternating current with 1.5 amperes is momentarily impressed through the heart between the electrodes.Usually a series of such shocks is necessary to accomplish defibrillation. If the treatment is successful, the ventricles cease fibrillating and remain in standstill momentarily before a supraventricular rhythm is established. Massage is again continued until the vigor of the heart beat is sufficient to empty the cardiac cavities of blood. Defibrillation of the human ventricles at the operating table has been performed five times at this hospital in the past, but all patients have subsequently died

without regaining consciousness. We are reporting the first case with complete recovery after prolonged ventricular fibrillation. We present it with the hope that, following Beck's suggestion, operating rooms will be equipped to handle cases of sudden ventricular fibrillation and that personnel will be trained in the method. Speed and precision in the technique are important.

 

A boy aged 14, was admitted to Dr. Claude Beck's service of this hospital for sternal resection because of severe congenital funnel chest. …During the closure of the wound in the chest, the pulse suddenly stopped and blood pressure sounds could not be heard. The patient was apparently dead. The wound was reopened and cardiac massage immediately was initiated…. The mechanical respirator was attached to the intratracheal tube and cardiac massage continuously given for the next thirty-five minutes, at the end of which time the electrocardiogram was characteristic of ventricular fibrillation. Another record ten minutes later was recorded just prior to the first electric shock applied directly to the heart. This record, as well as the tracing recorded immediately after the first shock, also showed ventricular fibrillation. Since the first shock was unsuccessful, procaine hydrochloride was injected into the right auricle, the heart massaged and a second series of shocks given. The heart then was in standstill.

Almost immediately, however, feeble, regular and fairly rapid cardiac contractions were seen, but massage was continued for five more minutes, at which time it was obvious that contractions were coordinated and fairly vigorous, though still fast. An electrocardiogram taken at this time revealed a supraventricular tachycardia at a rate of 175. From this point on the heart gradually increased in vigor and brachial sounds were heard at 50 mm. of mercury.

Beck CS, Pritchard WH, Feil HS. Ventricular Fibrillation of Long Duration Abolished by Electric Shock. J Amer Med Assoc. 1947; 135(15):985-986.

Geddes LA, Hamlin R. The First Human Heart Defibrillator. Amer J Cardiol 1983; 52:403-405

All photos of the Beck Defibrillator are courtesy of The Smithsonian Institution

 

 

Long Term Ambulatory Exteriorized Transvenous Pacing

HN, a 67-year-old man with 2:1 and complete heart block had had syncopal episodes for several years. He underwent insertion of a transvenous lead via cephalic vein cut down, on May 19, 1959, was hospital discharged on June 23, 1959 and lived at home as an ambulatory outpatient until November 1962. During that time he was paced with the newly available, battery operated model 902M (Atronic Products, Inc. Bala Cynwyd, PA, USA). The unit was capable of sensing spontaneous cardiac activity (but not of output inhibition in response to such sensing), of variation in output and stimulation rate and general evaluation of the impedance of the electrode system. A small meter indicated emission of stimuli or sensed events. A permanently attached cable delivered output to the electrodes. An audio output plug connector was available. Because the endocardial lead exited through the skin, it was fastened in place with stainless steel sutures which required frequent renewal. Though systemic infection did not occur the entry wound was frequently superficially infected, requiring cleansing and redressing. On November 8, 1962, after 41 months of such pacing he underwent thoracotomy for implantation of a pacemaker system, as a matter of potential convenience rather than to resolve pacing problems. He never fully recovered from surgery and died twenty days later.

 

Schwedel JB, Furman S, Escher DJW. Use of an Intracardiac Pacemaker in the treatment of Stokes-Adams Seizures. Prog Cardiovasc Dis 1960;3:170-177.

 

 

First Working Pacemaker Implant

 

 

CATALOGUE # : 850610
# PARTS: 003
Type: OPEN CHEST
Model: S-D4
Serial #: 11/PROTOTYPE
Manufacturer: NRC
Address #:OTTAWA ON CAN
Year Code: X From Date: 1950 To Date: 1955
Article Eng Description: STIMULATOR & DEFIBRILLATOR
Comments:
BREAKDOWN: 1 Stimulator-difibrillator; 2 Foot Padel Micro Switch; 3 Two Electrdes/Foot Pedal allows surgeon to control flow of electricity while positioning electrodesby hand/electrodes placed on either side of the heart for open chest model on either side of chest wall in later closed chest mdels/outcome of hypothermia experiments by hopps and bigelow/appeared on CBC local TV news Aug.2, 1985.

 

Clarence Walton Lillehei: The father of Cardiac Surgery

Development of surgery of heart has been one of the most dramatic phenomena of the 20th century. Indeed, C.Walten Lillehei played a heroic character on stage for more than 40 years. Dr. Denton Cooley describes him as “Role model for investigators.”32 One such example is found from his speech delivered at the Bakken Library and Museum, MN, USA June 18, 1996 where there is a mention of an experimental pacing technique (Fig.5) for patients with heart blocks due to surgical correction of septal defects. Lillehei started suturing insulated stainless steel wires to the heart before closing the chest. Pacing impulses could be delivered through this wire for a week or so until the heart healed. Then the wire could be withdrawn with a simple pull.[33]First such operation was performed on a girl with post-surgical heart block on 30th January 1957.[34],[35]

The battery operated pacemaker by Lillehei and Bakken (1957)

This method was universally adopted by cardiac surgeons, till Lillehei introduced transistor pacemaker later that year. The prototype model was “Compact, being only slightly larger than a package of cigarettes.”[36] The electrodes were insulated silver plated copper wires with exposed tips supplied by Mr.C.W.Norman.

The intramyocardial electrodes were connected to a self-contained external pacemaker having a transistor and a mercury battery of 9.4 volts. The disadvantage of this techniques included dislodgement of the lead and steadily rising threshold of the myocardial wire electrodes.36 For their pioneering of pacemakers, Dr. Lillehei and Earl Bakken, along with Wilson Greatbach were recognized by the National Society of Professional Engineers on the occasion of the Society’s 50th anniversary as making one of the 10 outstanding engineering advances in 20th century.[37]

 

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Radiofrequency Epicardial Pacing

 

Soon after the introduction of cardiac pacing with exteriorized myocardial electrodes it was apparent that peri-electrode infections would limit long-term pacing. To avoid this complication there was developed and introduced clinically in 1958-59 a totally implantable battery-powered pacemaker and a radiofrequency (RF) stimulator inductively coupled through intact skin (Mauro’s technique) to pace the heart. After several years, the addition of a long-lasting lithium battery and the ability to externally program the pacing parameters favored the sole use of a totally implantable cardiac pacemaker.

The use of the rf induction method for stimulating excitable tissue was expanded to pace the diaphragm, contract the paralyzed urinary bladder and muscle sphincters, and enhance hearing (cochlear implant).

Glenn WWL, Mauro A, Longo E, Lavietes PH, MacKay FJ The Radiofrequency Cardiac Pacemaker. Remote stimulation of the heart by radiofrequency transmission. Clinical application to a patient with Stoke-Adams Syndrome. New Engl J Med 1959:262;948-951.

 

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Early Pacemaker Development

In 1958, in Sweden, the first attempts at pacing with an implantable pacemaker were made. Because cardiac stimulation through external wires presented risk of infection, I developed a pacemaker, at the initiative of Dr. Senning that was small enough to implant subcutaneously in the epigastrium.

 

At that time it was thought that the pulse generator should deliver impulses of about 2 volts and an impulse period of about 1.5 ms at a rate of 70-80 per minute, using as little energy as possible. Fortunately, silicon transistors had just appeared on the market.

Among the many types of primary cells, the Ruben-Mallory cells with zinc as the anode and mercuric-oxide as the depolarizer were a possible choice. I had already had experience with the mercury cells … their lifetime was short. Besides, I did not know what effect the hydrogen gas development at the zinc anode would have on a cell encapsulated in plastic. For that reason, nickel-cadmium rechargeable cells were then chosen. Two cells of 60 mAh each were connected in series.

A coil with a diameter of about 50 mm was connected to the cells via a silicon diode. The charging current came from a line-connected vacuum tube radiofrequency generator with a frequency of 150 kHz. A large flexible coil in the output circuit of the generator could be attached to the patient's abdomen with adhesive tape. Recharging was done overnight … about once a month. The whole apparatus was encapsulated in epoxy resin. The diameter was about 55 mm and the thickness about 16 mm.

The first apparatus had two electrode wires, each consisting of a twined, stainless suture wire with polyethylene insulation sewn in the myocardium … It soon appeared that the wire was unsuitable as an electrode. The stimulation threshold increased and after only a few weeks, the unit ceased to stimulate. The patient again went into heart block, but the Adams-Stokes attacks did not recur.

American manufacturers were predicting a five year lifetime for pacemakers with mercury-zinc batteries, and since we felt that rechargeable units were cumbersome for patients, we also began to use mercury-zinc cells. I am not convinced that it was right to give up the rechargeable cells since, at that time, the quality of mercury cells was not high enough.

I must admit that I had regarded the pacemaker more or less as a technical curiosity. It has, therefore, been gratifying for me to follow its enormous success, and to have taken part in its development.

 

Elmqvist R. Review of Early Pacemaker Development. PACE 1978; 1:535-536.

Canadian Medical Innovation, Developed and Manufactured at National Research Council, Canada.

 

 

Example of very early Cardiac Stimulator-Difibrillator. (First was built by Jack Hopps C. 1950) Instrument used 60-Hz current at voltages up to 220V to arrest fibrillation through the open chest. The shocks regulated and/or restarted the beating of heart (stimulation), or were intended to instaneously stop and restart beating of heart muscle.

Function: To stimulate a stopped heart to resume beating, and to regulate heart-beat.

Significance to Technology:
Experimental pacemakers used to study the threshold of pacing, non- implantable because researchers needed across to the controls to vary the speed.

More sophisticated version of round pacemakers 850601. Prototype variable speed pacemakers for laboratory use to study the threshold of heart pacing, waveform studies and pulse widths.

CATALOGUE # : 850601
# PARTS: 003
Type : NON-IMPLANTABLE/ROUND
Serial # : PROTOTYPE
Manufacturer : NRC
Address # :OTTAWA ON CAN
Year Code : X From Date: 1965 To Date: 1970
Article Eng Description: PACEMAKER, CARDIAC
Comments : NO. BREAKDOWN:.1-.3 PACEMAKERS/

Used on dogs, plugged into an external opening in the back of the animal, held in place with a silastic interface. At one time Dr. O.Z. Ror had 6 dogs connected to external pacemakers at once in a long term study of the efficiency of heart pacemakers.

Significance to Canada:
Part of NRC pacemaker program. 1st Pacemaker developed at NRC in 1950 by John Hopps was approximately 30CM long and several CM high & wide.

Significance to Technology:
Development of transistors & reliable batteries permitted design of pacemaker of implantable size (1957). Pacemaker regarded as one of the greatest Canadian engineering achievements of the 20^th century.

 

CATALOGUE # : 850602 # PARTS: 004 Type: NON-IMPLANTABLE/SQUARE Serial #: PROTOTYPE Manufacturer: NRC Address # : OTTAWA ON CAN Year Code : C From Date: 1965 To Date: 1970 Article Eng Description: PACEMAKER, CARDIAC & ELECTRODE Comments: NO. BREAKDOWN:.1-.3 PACEMAKERS;.4 SINGLE ELECTRODE/ Used on dogs, connected to opening in back of animal & held in place with silastic interface. At one time Dr. O.Z. Roy had 6 dogs connected to external pacemakers at once in a long term study of the efficiency of heart pacemakers.

 

Reprinted courtesy of National Research Council of Canada

Manufacturer : National Research Council of Canada Address # : OTTAWA ONTARIO CANADA Date: 1965 To 1970 Oblong type used in experimental program to deliver electrical stimulus to the heart, in order to stimulate rhythmic heart beat. Tried in animal experiment of biological energy supplies, in which metals in contact with body fluids acted as a natural battery.

 

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Transformer-Type Cardiac Pacemaker (Direct Induction Pacemaker)

 

This pacemaker consists of an external pulse generator (a), an external transmitting coil (b), an internal receiving coil (c), and myocardial electrode (d). Both the transmitting and receiving coils contain an iron-core strip, with which effective electromagnetic coupling between the coils is achieved, thus inducing stimulating pulses in the receiving coil without high frequency carrier waves. From 1964 to 1968, the pacemaker was used in fourteen patients at the University of Tokyo Hospital. The average period of usage was forty months (two months to ten years and four months). Suma, K. et al: Direct induction pacemaker. Digest 6th Int Conf Med Elect Biol Eng (Tokyo) 1965; 96-97.

 

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A Self-contained, Implantable Cardiac Pacemaker

 

After two years of experimental work in the animal laboratory the patient shown in the photograph was referred to me. 77 years old, he was in complete heart block. The operation was completed in June 1960. His subsequent course was uneventful until he died two years later of natural causes. He was the first patient whose heart block was corrected successfully, on a long-term basis (years) by an implanted pacemaker carrying its own power supply. The case was reported in 1960 and I am gratified and grateful that the statements in the title of the report are still valid.  Chardack WM, Gage AA, Greatbatch W. A Transistorized, Self-contained, Implantable Pacemaker For The Long-Term Correction of Complete Heart Block. Surgery 1960; 48:643-664