(1915–2001) became the first person to receive an implantable pacemaker. He had 26 devices during his life and campaigned for other patients needing pacemakers.
Origin In 1889,
John Alexander MacWilliam reported in the
British Medical Journal (BMJ) of his experiments in which application of an electrical impulse to the human heart in
asystole caused a
ventricular contraction and that a heart rhythm of 60–70 beats per minute could be evoked by impulses applied at spacings equal to 60–70/minute. In 1926,
Mark C Lidwill of the
Royal Prince Alfred Hospital of Sydney, supported by physicist Edgar H. Booth of the
University of Sydney, devised a portable apparatus which "plugged into a lighting point" and in which "One pole was applied to a skin pad soaked in strong salt solution" while the other pole "consisted of a needle insulated except at its point, and was plunged into the appropriate cardiac chamber". "The pacemaker rate was variable from about 80 to 120 pulses per minute, and likewise the voltage variable from 1.5 to 120 volts". In 1928, the apparatus was used to revive a
stillborn infant at
Crown Street Women's Hospital in Sydney, whose heart continued "to beat on its own accord", "at the end of 10 minutes" of stimulation. In 1932, American physiologist
Albert Hyman, with the help of his brother, described an electro-mechanical instrument of his own, powered by a spring-wound hand-cranked motor. Hyman himself referred to his invention as an "artificial pacemaker", the term continuing in use to this day. An apparent
hiatus in the publication of research conducted between the early 1930s and
World War II may be attributed to the public perception of interfering with nature by "reviving the dead". For example, "Hyman did not publish data on the use of his pacemaker in humans because of adverse publicity, both among his fellow physicians, and due to newspaper reporting at the time. Lidwell may have been aware of this and did not proceed with his experiments in humans". The device was first tested on a dog at the
University of Toronto's
Banting Institute. A substantial external device using
vacuum tube technology to provide
transcutaneous pacing, it was somewhat crude and painful to the patient in use and, being powered from an AC wall socket, carried a potential hazard of
electrocution of the patient and inducing
ventricular fibrillation. A number of innovators, including
Paul Zoll, made smaller but still bulky transcutaneous pacing devices from 1952 using a large rechargeable battery as the power supply. In 1957, William L. Weirich published the results of research performed at the
University of Minnesota. These studies demonstrated the restoration of heart rate, cardiac output and mean aortic pressures in animal subjects with complete
heart block through the use of a
myocardial electrode. In 1958 Colombian doctor Alberto Vejarano Laverde and Colombian electrical engineer
Jorge Reynolds Pombo constructed an external pacemaker, similar to those of Hopps and Zoll, weighing 45 kg and powered by a 12 volt car
lead–acid battery, but connected to electrodes attached to the heart. This apparatus was successfully used to sustain a 70-year-old priest, Gerardo Florez. The development of the
silicon transistor and its first commercial availability in 1956 was the pivotal event that led to the rapid development of practical cardiac pacemaking.
Wearable In 1958, engineer
Earl Bakken of Minneapolis, Minnesota, produced the first wearable external pacemaker for a patient of
C. Walton Lillehei. This transistorized pacemaker, housed in a small plastic box, had controls to permit adjustment of pacing heart rate and output voltage and was connected to electrode
leads which passed through the skin of the patient to terminate in electrodes attached to the surface of the
myocardium of the heart. In the UK in the 1960s, Lucas Engineering in
Birmingham was asked by Mr Abrams of The
Queen Elizabeth Hospital to produce a prototype for a transistorised replacement for the electro-mechanical product. The team was headed by Roger Nolan, an engineer with the Lucas Group Research Centre. Nolan designed and created the first blocking oscillator and transistor-powered pacemaker. This pacemaker was worn on a belt and powered by a rechargeable sealed battery, enabling users to live a more-normal life. One of the earliest patients to receive this Lucas pacemaker device was a woman in her early 30s. The operation was carried out in 1964 by South African cardiac surgeon Alf Gunning, a student of
Christiaan Barnard. This pioneering operation took place under the guidance of cardiac consultant
Peter Sleight at the
Radcliffe Infirmary in Oxford and his cardiac research team at St George's Hospital in London.
Implantable The first clinical implantation into a human of a fully implantable pacemaker was on October 8, 1958, at the
Karolinska Institute in Solna,
Sweden, using a pacemaker designed by inventor
Rune Elmqvist and surgeon
Åke Senning (in collaboration with Elema-Schönander AB, later Siemens-Elema AB), connected to electrodes attached to the
myocardium of the heart by
thoracotomy. The device failed after three hours. A second device was then implanted which lasted for two days. The world's first implantable pacemaker patient,
Arne Larsson, went on to receive 26 different pacemakers during his lifetime. He died in 2001, at the age of 86, outliving the inventor and the surgeon. In 1959, temporary
transvenous pacing was first demonstrated by Seymour Furman and John Schwedel, whereby the
catheter electrode was inserted via the patient's
basilic vein. In February 1960, an improved version of the Swedish Elmqvist design was implanted by Doctors
Orestes Fiandra and Roberto Rubio in the Casmu 1 Hospital of
Montevideo, Uruguay. This pacemaker, the first implanted in the Americas, lasted until the patient died of other ailments, nine months later. The early Swedish-designed devices used batteries recharged by an induction coil from the outside. Implantable pacemakers constructed by engineer
Wilson Greatbatch entered use in humans from April 1960 following extensive
animal testing. The Greatbatch innovation varied from the earlier Swedish devices in using primary cells (a
mercury battery) as the energy source. The first patient lived for a further 18 months. The first use of
transvenous pacing in conjunction with an implanted pacemaker was by
Parsonnet in the United States, Lagergren in Sweden and Jean-Jacques Welti in France in 1962–63. The transvenous, or pervenous, procedure involved incision of a vein into which was inserted the
catheter electrode lead under
fluoroscopic guidance, until it was lodged within the
trabeculae of the right ventricle. This became the method of choice by the mid-1960s. Cardiothoracic surgeon
Leon Abrams and medical engineer
Ray Lightwood developed and implanted the first patient-controlled variable-rate heart pacemaker in 1960 at
the University of Birmingham. The first implant took place in March 1960, with two further implants the following month. These three patients made good recoveries and returned to a high quality of life. By 1966, 56 patients had undergone implantation with one surviving for over years.
Lithium battery . 1972 The preceding implantable devices all suffered from the unreliability and short lifetime of the available primary cell technology, mainly the
mercury battery. In the late 1960s, several companies, including
ARCO in the US, developed
isotope-powered pacemakers, but this development was overtaken by the development in 1971 of the
lithium iodide cell by
Wilson Greatbatch. Lithium-iodide or lithium anode cells became the standard for pacemaker designs. A further impediment to the reliability of the early devices was the diffusion of water vapor from body fluids through the
epoxy resin encapsulation, affecting the electronic circuitry. This phenomenon was overcome by encasing the pacemaker generator in a hermetically sealed metal case, initially by
Telectronics of Australia in 1969, followed by
Cardiac Pacemakers, Inc. of
St. Paul, Minnesota in 1972. This technology, using
titanium as the encasing metal, became the standard by the mid-1970s. On July 9, 1974,
Manuel A. Villafaña and
Anthony Adducci, the founders of
Cardiac Pacemakers, Inc. (
Guidant), manufactured the world's first pacemaker with a lithium anode and a lithium-iodide electrolyte solid-state battery. Lithium-iodide or lithium anode cells increased the life of pacemakers from one year to as long as eleven years, and has become the standard for pacemaker designs. They began designing and testing their implantable cardiac pacemaker powered by a new longer-life lithium battery in 1971. The first patient to receive a CPI pacemaker emerged from surgery in June 1973. Liza Morton was fitted with an implantable pacemaker at 11 days old in 1978, at Glasgow's Yorkhill hospital, Scotland. She was the youngest baby to bear such an implant at the time.
Intra-cardial In 2013, several firms announced devices that could be inserted via a leg catheter rather than invasive surgery. The devices are roughly the size and shape of a pill, much smaller than the size of a traditional pacemaker. Once implanted, the device's prongs contact the muscle and stabilize heartbeats. Development of this type of device was continuing. In November 2014, Bill Pike of
Fairbanks, Alaska, received a
Medtronic Micra pacemaker in Providence St Vincent Hospital in
Portland, Oregon. D. Randolph Jones was the EP doctor. Also in 2014,
St. Jude Medical Inc. announced the first enrollments in the company's leadless Pacemaker Observational Study evaluating the Nanostim leadless pacing technology. The Nanostim pacemaker received European
CE marking in 2013. Post-approval implant trials were carried out in Europe. The European study was stopped after reports of six perforations that led to two patient deaths. After investigations, St Jude Medical restarted the study. In the United States, this therapy had not been approved by the FDA . While the St Jude Nanostim and the Medtronic Micra are single-chamber pacemakers, it was anticipated that leadless dual-chamber pacing for patients with atrioventricular block would become possible with further development.
Reusable pacemakers Worldwide each year, in a simple procedure to avoid explosions, thousands of pacemakers are removed from bodies to be cremated. Pacemakers with significant remaining battery life are potentially life-saving devices for people in low- and middle-income countries (LMICs). The
Institute of Medicine, a US
non-governmental organization, has reported that inadequate access to advanced cardiovascular technologies is a major contributor to cardiovascular disease morbidity and mortality in LMICs. Ever since the 1970s, multiple studies worldwide have reported on the safety and efficacy of pacemaker reuse. , widely acceptable standards for safe pacemaker and ICD reuse had not been developed, and there continued to be legal and regulatory barriers to widespread adoption of medical device reuse. == In animals ==