Editing Pacemaker (section)

== History ==
[[File:Arne Larsson.jpg|thumb|In 1958, [[Arne Larsson (patient)|Arne Larsson]] (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 ''[[BMJ|British Medical Journal]]'' (BMJ) of his experiments in which application of an electrical impulse to the human heart in [[asystole]] caused a [[Ventricle (heart)|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.<ref>{{cite journal |author=McWilliam JA |year=1889 |title=Electrical stimulation of the heart in man |journal=Br Med J |volume=1 |issue= 1468|pages=348–50 |doi=10.1136/bmj.1.1468.348 |pmc=2154721 |pmid=20752595 }}</ref>

In 1926, [[Dr Mark Cowley Lidwill|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".<ref>{{cite book |doi=10.1002/9781119333050.ch1 |chapter=History of cardiac pacing and defibrillation in the young |title=Cardiac Pacing and Defibrillation in Pediatric and Congenital Heart Disease |date=2017 |last1=Rhodes |first1=Larry |last2=Campbell |first2=Robert |pages=1–11 |isbn=978-0-470-67109-2 }}</ref> In 1928, the apparatus was used to revive a [[Stillbirth|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.<ref>Lidwell M C, "Cardiac Disease in Relation to Anaesthesia" in ''Transactions of the Third Session'', Australasian Medical Congress, Sydney, Australia, Sept. 2–7, 1929, p. 160.</ref><ref name="Mond_1982">{{cite journal |vauthors=Mond HG, Sloman JG, Edwards RH | title = The first pacemaker | journal = Pacing and Clinical Electrophysiology | volume = 5 | issue = 2 | pages = 278–82 | year = 1982 | pmid = 6176970 | doi = 10.1111/j.1540-8159.1982.tb02226.x | s2cid = 22049678 }}</ref>

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.<ref>{{cite journal |last1=Aquilina |first1=O |title=A brief history of cardiac pacing |journal=Images in Paediatric Cardiology |date=2006 |volume=8 |issue=2 |pages=17–81 |pmc=3232561 |pmid=22368662 }}</ref><ref>{{cite journal | vauthors = Furman S, Szarka G, Layvand D | title = Reconstruction of Hyman's second pacemaker | journal = Pacing Clin Electrophysiol | volume = 28 | issue = 5 | pages = 446–53 | year = 2005 | pmid = 15869680 | doi = 10.1111/j.1540-8159.2005.09542.x | s2cid = 29138993 }}</ref>

An apparent [[Wikt:hiatus|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".<ref>{{Cite book |last1=Kidder |first1=David S. |url=https://books.google.com/books?id=Z5gfbaYTWlkC&dq=%22reviving+the+dead%22+pacemaker&pg=PA308 |title=The Intellectual Devotional: Health: Revive Your Mind, Complete Your Education, and Digest a Daily Dose of Wellness Wisdom |last2=Oppenheim |first2=Noah D. |last3=Young |first3=Bruce K. |year=2009 |publisher=Harmony/Rodale |isbn=978-1-60529-330-1 |language=en}}</ref> 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".<ref name="Mond_1982" />

=== Transcutaneous ===
In 1950, Canadian electrical engineer [[John Alexander Hopps|John Hopps]] designed and built the first external pacemaker based upon observations by cardio-thoracic surgeons [[Wilfred Gordon Bigelow]] and [[John Callaghan (physician)|John Callaghan]] at [[Toronto General Hospital]].<ref>{{Cite web|url=http://collectionscanada.gc.ca/pam_archives/index.php?fuseaction=genitem.displayItem&lang=eng&rec_nbr=104318&rec_nbr_list=104318,3588818,815761,4385271,4385234,4385226,4385302,4385311,4385420,4385246|archive-url=https://web.archive.org/web/20200728125042/https://collectionscanada.gc.ca/pam_archives/index.php?fuseaction=genitem.displayItem&lang=eng&rec_nbr=104318&rec_nbr_list=104318,3588818,815761,4385271,4385234,4385226,4385302,4385311,4385420,4385246|url-status=dead|archive-date=2020-07-28|title=John Alexander Hopps fonds|date=2008-03-19|website=Archival description|publisher=[[Library and Archives Canada]]|access-date=16 Sep 2016}}</ref> The device was first tested on a dog at the [[University of Toronto]]'s Banting Institute.<ref>{{cite web|url=http://www.ieee.ca/history/milestones/pacemaker.html|title=IEEE Milestone in Electrical Engineering and Computing|access-date=September 5, 2009|archive-date=February 25, 2021|archive-url=https://web.archive.org/web/20210225103835/http://www.ieee.ca/history/milestones/pacemaker.html|url-status=dead}}</ref> 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 [[electric shock|electrocution]] of the patient and inducing [[ventricular fibrillation]].<ref>{{Cite book |last=Silva |first=Regis A. de |url=https://books.google.com/books?id=NI0LtnwdBg0C&dq=John+Hopps+external+pacemaker+vacuum+tube&pg=PA14 |title=Heart Disease |year=2013 |publisher=ABC-CLIO |isbn=978-0-313-37607-8 |language=en}}</ref>

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.<ref>{{cite web |title=Paul Maurice Zoll |url=https://news.harvard.edu/gazette/story/2001/04/harvard-gazette-paul-maurice-zoll/ |website=Harvard Gazette |date=19 April 2001 }}</ref>

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.<ref>{{cite journal |vauthors=Weirich WL, Gott VL, Lillehei CW | title = The treatment of complete heart block by the combined use of a myocardial electrode and an artificial pacemaker | journal = Surg Forum | volume = 8 | pages = 360–63 | year = 1957 | pmid = 13529629 }}</ref>

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&nbsp;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.<ref>{{cite journal |last1=Reynolds |first1=Jorge |title=The Early History of Cardiac Pacing in Colombia |journal=Pacing and Clinical Electrophysiology |date=March 1988 |volume=11 |issue=3 |pages=355–61 |doi=10.1111/j.1540-8159.1988.tb05018.x |pmid=2452427 |s2cid=20374411 }}</ref>

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.<ref>{{Cite journal |first2=Victor |last2=Parsonnet |first1=Kirk |last1=Jeffrey |date=19 May 1998 |title=Cardiac Pacing, 1960–1985 |journal=Circulation |volume=97 |issue=19|pages=1978–91 |doi=10.1161/01.CIR.97.19.1978 |pmid=9609092 |doi-access=free }}</ref>

=== 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 [[Lead (electronics)|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 Birmingham|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,<ref>{{cite web|url=http://livesonline.rcseng.ac.uk/biogs/E001783b.htm |title= Gunning, Alfred James – Biographical entry – Plarr's Lives of the Fellows Online |publisher=Livesonline.rcseng.ac.uk |access-date=2013-12-29}}</ref><ref>{{cite web |url=http://www.nds.ox.ac.uk/about-us/our-history |title=Our history |website = Nuffield Department of Surgical Sciences |publisher=University of Oxford |access-date=26 October 2020}}</ref> 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.<ref>{{cite web|url=http://www.bcs.com/pages/Cardiac_Pacemakers.asp |title=British Cardiovascular Society |publisher=Bcs.com |access-date=2013-12-29 |url-status=dead |archive-url=https://web.archive.org/web/20131212164351/http://www.bcs.com/pages/Cardiac_Pacemakers.asp |archive-date=2013-12-12 }}</ref><ref>{{cite journal |last1=Record |first1=C O |last2=Sleight |first2=P |last3=Gunning |first3=A J |last4=Kenworthy-Browne |first4=J M |last5=Richings |first5=M |title=Treatment of chronic heart block with the Lucas induction coil pacemaker |journal=Heart |date=1 November 1971 |volume=33 |issue=6 |pages=938–42 |doi=10.1136/hrt.33.6.938 |pmid=5120241 |pmc=458452 }}</ref>

=== Implantable ===
[[File:PPM.png|thumb|350px|Illustration of implanted cardiac pacemaker showing locations of cardiac pacemaker leads]]
The first clinical implantation into a human of a fully implantable pacemaker was on October 8, 1958,<ref>{{cite book |last1=Tesler |first1=Ugo Filippo |title=A History of Cardiac Surgery: An Adventurous Voyage from Antiquity to the Artificial Heart |date=2020 |publisher=Cambridge Scholars Publishing |isbn=978-1-5275-4480-2 |page=151 }}</ref> 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 (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.<ref>{{cite news|last=Altman| first=Lawrence| title=Arne H. W. Larsson, 86; Had First Internal Pacemaker| url=https://www.nytimes.com/2002/01/18/world/arne-h-w-larsson-86-had-first-internal-pacemaker.html|access-date=3 March 2014|newspaper=New York Times|date=18 Jan 2002}}</ref>

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]].<ref>{{cite journal |vauthors=Furman S, Schwedel JB | title = An intracardiac pacemaker for Stokes-Adams seizures | journal = N. Engl. J. Med. | volume = 261 | issue = 5 | pages = 943–48 | year = 1959 | pmid = 13825713 | doi=10.1056/NEJM195911052611904}}</ref>

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 [[Victor Parsonnet|Parsonnet]] in the United States,<ref name="pmid83641">{{cite journal | vauthors = Parsonnet V | title = Permanent transvenous pacing in 1962 | journal = Pacing Clin Electrophysiol | volume = 1 | issue = 2 | pages = 265–68 | year = 1978 | pmid = 83641 | doi = 10.1111/j.1540-8159.1978.tb03472.x| s2cid = 12263609 }}</ref><ref>{{cite journal | title = Preliminary Investigation of the Development of a Permanent Implantable Pacemaker Using an Intracardiac Dipolar Electrode |vauthors=Parsonnet V, Zucker IR, Asa MM | journal = Clin. Res. | volume = 10  | pages = 391 | year = 1962}}</ref><ref name="pmid14484083">{{cite journal | vauthors = Parsonnet V, Zucker IR, Gilbert L, Asa M | title = An intracardiac bipolar electrode for interim treatment of complete heart block | journal = Am. J. Cardiol. | volume = 10 | issue = 2| pages = 261–65 | year = 1962 | pmid = 14484083 | doi =10.1016/0002-9149(62)90305-3 }}</ref> Lagergren in Sweden<ref>{{cite journal | author = Lagergren H | title = How it happened: my recollection of early pacing | journal = Pacing Clin Electrophysiol | volume = 1 | issue = 1 | pages = 140–43 | year = 1978 | pmid = 83610 | doi = 10.1111/j.1540-8159.1978.tb03451.x | s2cid = 9118036 }}</ref><ref>{{cite journal |vauthors=Lagergren H, Johansson L | title = Intracardiac stimulation for complete heart block | journal = Acta Chirurgica Scandinavica | volume = 125 | pages = 562–66 | year = 1963 | pmid = 13928055 }}</ref> and Jean-Jacques Welti in France<ref>Jean Jacques Welti:Biography, Heart Rhythm Foundation{{Full citation needed|date=October 2020}}</ref> in 1962–63.
The transvenous, or pervenous, procedure involved incision of a vein into which was inserted the [[catheter]] electrode lead under [[Fluoroscopy|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 {{frac|5|1|2}} years.<ref>[http://www.birmingham.ac.uk/documents/culture/bookletfinalpdf.pdf Blue Plaque Guide]</ref><ref>{{cite web|url=http://bhamalumni.org/NetCommunity/Page.aspx?pid=1111&frcrld=1|archive-url=https://web.archive.org/web/20141006065509/http://bhamalumni.org/NetCommunity/Page.aspx?pid=1111&frcrld=1|url-status=dead|archive-date=2014-10-06|title=University of Birmingham|work=bhamalumni.org}}</ref>

=== Lithium battery ===
[[File:Cardiac pacer with sold-state power source.jpg|thumb|350x350px|The first lithium-iodide cell-powered pacemaker. Invented by Anthony Adducci and Art Schwalm. [[Cardiac Pacemakers, Inc.|Cardiac Pacemakers Inc]]. 1972<ref name="Schwalm1974">{{Cite patent|country=US|number=3822707|title=Metal-enclosed cardiac pacer with solid-state power source|pubdate=1974-07-09|gdate=1972-04-17|inventor1-last=Adducci|inventor1-first=Anthony J.|inventor2-last=Schwalm|inventor2-first=Arthur W.|assign= Cardiac Pacemekers Inc.}}</ref>]]
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 [[Atomic battery|isotope-powered]] pacemakers, but this development was overtaken by the development in 1971 of the [[lithium iodide]] cell by [[Wilson Greatbatch]].<ref>{{Cite web |title=The History of Nuclear Powered Pacemakers |url=http://large.stanford.edu/courses/2015/ph241/degraw2/ |access-date=2023-04-18 |website=large.stanford.edu}}</ref> 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#Medical|titanium]] as the encasing metal, became the standard by the mid-1970s.

On July 9, 1974, [[Manny Villafaña|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.<ref name="Schwalm1974" /><ref>{{cite web|title=Pioneers of the Medical Device Industry| url=http://www.mnhs.org/collections/medTech/org_cardiac_pacemakers.php| publisher=Minnesota Historical Society}}</ref>

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 at the time.<ref>{{cite journal| title= Permanent cardiac pacemaker in infants and children | date= 1986| pmid= 2429390| url= https://pubmed.ncbi.nlm.nih.gov/2429390/| last1= Dasmahapatra| first1= H. K.| last2= Jamieson| first2= M. P.| last3= Brewster| first3= G. M.| last4= Doig| first4= B.| last5= Pollock| first5= J. C.| journal= The Thoracic and Cardiovascular Surgeon| volume= 34| issue= 4| pages= 230–35| doi= 10.1055/s-2007-1020418}}</ref><ref>{{cite news| title= Doctors gave me a pacemaker when I was 11 days old | date= 17 January 2023| url= https://www.bbc.com/news/uk-scotland-tayside-central-64303138}}</ref>

=== 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.<ref>{{cite web| url=http://singularityhub.com/2013/12/27/medtronics-minimally-invasive-pacemaker-the-size-of-a-multivitamin/ |title=Medtronic's Minimally Invasive Pacemaker the Size of a Multivitamin |publisher=Singularity Hub |access-date=2013-12-29|date=2013-12-27 }}</ref> 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.<ref>{{cite web|url=http://www.dicardiology.com/article/european-post-approval-trial-nanostim-leadless-pacemaker-begins/ |title=European Post-Approval Trial for Nanostim |publisher=DAIC |date=2014-03-18 |access-date=2015-05-04}}</ref> The European study was stopped after reports of six perforations that led to two patient deaths. After investigations, St Jude Medical restarted the study.<ref>{{cite web| url=http://www.medscape.com/viewarticle/827034|publisher=Medscape|title=First-in-Human Data|access-date=2014-06-19}}</ref> In the United States, this therapy had not been approved by the FDA {{As of|2014|lc=y}}.<ref>{{cite web|title=Leadless Pacing from St. Jude Medical |url=http://www.sjm.com/leadlesspacing/intl/options/leadless-pacing |url-status=dead |archive-url=https://web.archive.org/web/20141029105333/http://www.sjm.com/leadlesspacing/intl/options/leadless-pacing |archive-date=2014-10-29 }}</ref> 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.<ref>{{cite web | last=Stiles | first=Steve | title=New Data on Leadless Pacemaker Supports Efficacy, Safety | website=Medscape | date=24 March 2014 | url=https://www.medscape.com/viewarticle/822457}}</ref>

=== 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).<ref>{{Cite news| url=https://www.bbc.com/news/health-24828244/ |title=British charity calls for re-use of pacemakers abroad |journal=BBC News |access-date=2018-07-31|date=2013-11-19 |last1=Mazumdar |first1=Tulip }}</ref> The [[National Academy of Medicine|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. {{As of|2016}}, 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.<ref>{{cite journal |last1=Crawford |first1=TC |last2=Eagle |first2=KA |title=Reuse of cardiac implantable electronic devices to improve and extend lives: a call to action. |journal=Heart Asia |date=2017 |volume=9 |issue=1 |pages=34–35 |doi=10.1136/heartasia-2016-010835 |pmid=28191825 |pmc=5278341}}</ref>