ESVS Volodos Lecture: Innovations and the Hippocratic Oath
2018; Elsevier BV; Volume: 55; Issue: 5 Linguagem: Inglês
10.1016/j.ejvs.2018.02.006
ISSN1532-2165
Autores Tópico(s)Cardiac, Anesthesia and Surgical Outcomes
ResumoThis lecture remembers Professor Nicolai Volodos, a pioneer innovator and a giant in vascular and endovascular surgery, who performed the first endovascular repair of a thoracic aneurysm in 1987 and developed a complex endovascular program by the end of the 1980s. The manuscript recalls major innovations and innovators in vascular surgery, examines the challenges innovators and those who adopt innovations face and discusses the modern meaning of the Hippocratic Oath. The author concludes that surgical innovations are essential to advance cost-effective care, and shared decision making on adopting new therapies by an ethical surgeon and a well informed patient is the cornerstone of ethical patient care. This lecture remembers Professor Nicolai Volodos, a pioneer innovator and a giant in vascular and endovascular surgery, who performed the first endovascular repair of a thoracic aneurysm in 1987 and developed a complex endovascular program by the end of the 1980s. The manuscript recalls major innovations and innovators in vascular surgery, examines the challenges innovators and those who adopt innovations face and discusses the modern meaning of the Hippocratic Oath. The author concludes that surgical innovations are essential to advance cost-effective care, and shared decision making on adopting new therapies by an ethical surgeon and a well informed patient is the cornerstone of ethical patient care. It is an exceptional honor to serve as the Nicolai Volodos honorary lecturer and I am grateful to the Executive Council of the European Society for Vascular Surgery (ESVS) and to President Martin Björck, for this distinction (Fig. 1). Last year we all enjoyed listening to the 1st Volodos lecture of Professor Ross Naylor, former editor in chief of the European Journal of Vascular and Endovascular Surgery. We heard about the war against error and learned just about everything we need to know of carotid artery interventions. Today, I would like to talk about innovations. About innovations in vascular surgery, about the Hippocratic Oath, what it means in 2017, and what ethical challenges we face when we develop and adopt surgical innovations. While the two terms are very similar in meaning, there are also distinct differences between inventions and innovations. Invention is a new idea or creation of a brand new device or process. It usually requires a great deal of scientific skill. Innovation is the application of a new or improved device or implementation of a new process. Innovation adds value to an invention, be it an idea or a device. Innovation meets existing or unarticulated needs and it requires scientific, technical, marketing and strategic skills. "Innovation is the most powerful force for change in the world" said Bill Gates, co-founder of Microsoft. Look at just one of many proposed lists of the top 12 revolutionary or disruptive innovations that have changed our lives during the past centuries (Table 1). The list includes the printing press, steel, electric light, telephone, automobile, computer, and the Internet, among others. The discovery and introduction of penicillin were considered by many to be the most important medical innovations.Table 1Twelve innovations that changed the world.1Printing press2Steel3Electric light4Telescope5Telegraph6Telephone7Steam engine8Automobile9Airplane10Penicillin11Computer12Internet Open table in a new tab As a surgical specialty, vascular surgery greatly benefitted from fundamental innovations of the 19th century that advanced general surgical care. These included the introduction of ether anaesthesia, first in Boston in 1846 by William Morton, of hand washing, by Ignaz Semmelweis, and the use of antiseptic solutions to fight surgical infections, proposed by Sir Joseph Lister.1Rutkow I.M. Surgery, an illustrated history. Mosby, St. Louis1993Google Scholar The number 1 of the top 12 innovations in vascular surgery was the development of the technique of vascular anastomoses (Fig. 2A,B).2Descotes J. A brief, prophetic and lucid article appeared in "Lyon Medical" in 1902 (Harbisson, Surgery. August 1962), or the surgical genius of Alexis Carrel.Lyon Med. 1969; : 157-159Google Scholar It is fascinating that this revolutionary innovation is closely connected to the host city of this meeting, Lyon, and the world exposition organised here in 1894. The unwanted publicity of the exposition was that a popular French president Marie François Sadi Carnot was assassinated.3Benveniste G.L. Alexis Carrel: the good, the bad, the ugly.ANZ J Surg. 2013; 83: 609-611Crossref PubMed Scopus (9) Google Scholar The president was fatally stabbed by a young anarchist with a dagger. Carnot bled to death due to laceration of his portal vein that his surgeons did not think they could repair. This event left a deep impression on a young surgical intern, a native of Lyon, Alexis Carrel, and stimulated him enormously to develop new effective techniques for suturing and repairing blood vessels. Lyon is well known as the world capital of gastronomy, but it has also been the world capital of silk. Carrel learned stitching from Madam Leroidier, one of the best embroiderers in Lyon.4Rooney A. The history of medicine. The Rosen Publishing Group, New York2013Google Scholar Using silk sutures, he developed a fine technique to perform vascular anastomoses with triangulation that he published in the Lyon Medicale in 1902.2Descotes J. A brief, prophetic and lucid article appeared in "Lyon Medical" in 1902 (Harbisson, Surgery. August 1962), or the surgical genius of Alexis Carrel.Lyon Med. 1969; : 157-159Google Scholar Soon after this, Carrel moved to the Unites States to work first in the laboratory of Charles Guthrie in Chicago and then at the Rockefeller Institute in New York. For his experimental work on vascular anastomoses and organ transplantation Alexis Carrel received the Noble Prize in 1912.5Alexis Carrel – Facts. 2014http://www.nobelprize.org/nobel_prizes/medicine/laureates/1912/carrel-facts.htmlGoogle Scholar It was unfortunate that later in his life Carrel became a Nazi sympathiser and supported eugenics to improve the genetic quality of the human population and even considered the execution of the frail and mentally ill. Because of his bad and sometime ugly philosophies that he explained in his book "Man the Unknown",6Carrel A. Man the Unknown. Harper and Brothers, New York1935Google Scholar he ultimately lost the support of the civilised world, his name was erased from the medical school here in Lyon as well as from streets and parks all over France.7Reggiani A.H. God's Eugenicist; Alexis Carrel and the Sociobiology of Decline. Berghan Books, New York2007Google Scholar Carrel's life is a monumental example that neither position nor great scientific achievements will justify unethical behaviors and a conduct so dishonorable to the Hippocratic Oath. Carrel's discoveries, however, opened up the way for vascular and cardiac surgery as well as for organ transplantation. Endarterectomy was introduced and followed by bypass, using vein, homograft, and prosthetic materials (Table 2). Fogarty invented his catheters, Greenfield introduced his filter, and endovascular interventions became possible using percutaneous balloons and stents. Endovenous thermal ablation with radiofrequency and laser catheters revolutionised the therapy of varicose veins and chronic venous insufficiency, stent grafts were introduced for the treatment of abdominal and thoracic aortic aneurysms and other pathologies, more recently adding branches and fenestrations to stent grafts.Table 2Twelve innovations that changed vascular surgery.1Vascular anastomoses2Endarterectomy3Vein bypass4Homograft repair of aortic aneurysms5Prosthetic grafts6Fogarty balloon catheter7Greenfield filter8Balloon angioplasty9Stents10Radiofrequency and laser ablation of veins11Stent grafts12Branched and fenestrated stent grafts Open table in a new tab The future of our specialty is bright. Cleveland clinic just named bio-absorbable stents one of the top 10 medical innovations of the year. Results using drug coated balloons and drug eluting stents are most promising and so is three dimensional printing, allowing better planning of complex vascular interventions. Strong leaders are essential to advance vascular surgery. Steve Jobs, once a great leader of Apple said that "innovation distinguishes between a leader and a follower." Professor Nikolai Volodos (Fig. 1) was a leader and a pioneer of endovascular therapy.8Ivancev K. Epilogue: following in the footsteps.J Endovasc Ther. 2013; 20: I24PubMed Google Scholar Volodos had already obtained a patent of a Z stent in 1984. After a series of flow models, haemodynamic assessments, and animal experiments, the first in man experience of applying a stent placed inside an "endoprosthesis" was performed on May 4, 1985, as a hybrid procedure.9Volodos N.L. Shekhanin V.E. Karpovich I.P. Troian V.I. Gur'ev Iu A. A self-fixing synthetic blood vessel endoprosthesis.Vestn Khir Im I I Grek. 1986; 137: 123-125PubMed Google Scholar This patient, followed by 17 others, was treated for occlusive disease of the iliac artery. Volodos commented 30 years later: "From the very beginning, endoprosthetic repair of the iliac arteries was not our primary goal, and we were already beginning to experiment with the insertion of stent grafts into the thoracic and abdominal aortas using models and cadavers, while we waited for suitable clinical cases to present." On March 24, 1987, he repaired a descending thoracic aortic pseudoaneurysm with an endoprosthesis in a 53 year old man. The patient lived more than 18 years after the operation (Fig. 3A,B).10Volodos N.L. Historical perspective: the first steps in endovascular aortic repair: how it all began.J Endovasc Ther. 2013; 20: I3-I23PubMed Google Scholar, 11Volodos N.L. Karpovich I.P. Shekhanin V.E. Troian V.I. Iakovenko L.F. A case of distant transfemoral endoprosthesis of the thoracic artery using a self-fixing synthetic prosthesis in traumatic aneurysm.Grudn Khir. 1988; : 84-86PubMed Google Scholar, 12Volodos N.L. The 30th Anniversary of the first clinical application of endovascular stent-grafting.Eur J Vasc Endovasc Surg. 2015; 49: 495-497Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar Volodos attempted transfemoral endovascular repair of an abdominal aortic aneurysm with a unibody bifurcated graft on December 6, 1989, but the procedure had to be converted to open repair because of torsion of one limb of the graft. This technique, however, was successfully performed by him on May 12, 1993.10Volodos N.L. Historical perspective: the first steps in endovascular aortic repair: how it all began.J Endovasc Ther. 2013; 20: I3-I23PubMed Google Scholar Initial reports of Volodos, who worked behind the iron curtain, were printed in Russian9Volodos N.L. Shekhanin V.E. Karpovich I.P. Troian V.I. Gur'ev Iu A. A self-fixing synthetic blood vessel endoprosthesis.Vestn Khir Im I I Grek. 1986; 137: 123-125PubMed Google Scholar, 11Volodos N.L. Karpovich I.P. Shekhanin V.E. Troian V.I. Iakovenko L.F. A case of distant transfemoral endoprosthesis of the thoracic artery using a self-fixing synthetic prosthesis in traumatic aneurysm.Grudn Khir. 1988; : 84-86PubMed Google Scholar with the exception of one manuscript, in 1991, published in a European medical journal that was searchable on PubMed.13Volodos N.L. Karpovich I.P. Troyan V.I. Kalashnikova Yu.V. Shekhanin V.E. Ternyuk N.E. et al.Clinical experience of the use of self-fixing synthetic prostheses for remote endoprosthetics of the thoracic and the abdominal aorta and iliac arteries through the femoral artery and as intraoperative endoprosthesis for aorta reconstruction.Vasa Suppl. 1991; 33: 93-95PubMed Google Scholar Volodos presented at multiple European congresses and also at the Veith symposium and the Phoenix meeting in 1994. His work was referenced the same year by Marin, Veith, and Parodi, among others,14Marin M.L. Veith F.J. Cynamon J. Sanchez L.A. Wengerter K.R. Schwartz M.L. et al.Transfemoral endovascular stented graft treatment of aorto-iliac and femoropopliteal occlusive disease for limb salvage.Am J Surg. 1994; 168: 156-162Abstract Full Text PDF PubMed Scopus (85) Google Scholar and, in 1995 by Parodi and colleagues.15Parodi J.C. Marin M.L. Veith F.J. Transfemoral, endovascular stented graft repair of an abdominal aortic aneurysm.Arch Surg. 1995; 130: 549-552Crossref PubMed Scopus (65) Google Scholar The magnitude of the pioneering contribution of Volodos, however, was not recognised. As Edward Dietrich16Diethrich E.B. SLED: the Serendipitous Life of Edward Dietrich. Orange Frazer Press, Wilmington, Ohio2016: 243Google Scholar stated, "in 1994 … language barrier prevented much scientific discussion" and "it was a missed opportunity that would not be set right until April 2012", when Krassi Ivancev presented the trailblazer endovascular program of Volodos at Roger Greenhalgh's Charing Cross meeting in London. This program became well known in the United States and around the world with a seminal publication in the Journal of Endovascular Therapy in 2013, where Volodos described the different endovascular techniques he applied to over 100 patients.10Volodos N.L. Historical perspective: the first steps in endovascular aortic repair: how it all began.J Endovasc Ther. 2013; 20: I3-I23PubMed Google Scholar In the Western world and certainly in the American continent the endovascular revolution began with the 1991 publication of Parodi, Palmaz, and Barone on their pioneer work on aortic stent grafts, implanted in five patients with abdominal aortic aneurysm, with the first operation performed on September 7, 1990.17Parodi J.C. Palmaz J.C. Barone H.D. Transfemoral intraluminal graft implantation for abdominal aortic aneurysms.Ann Vasc Surg. 1991; 5: 491-499Abstract Full Text PDF PubMed Scopus (2972) Google Scholar Parodi's work, in concept, started in 197617Parodi J.C. Palmaz J.C. Barone H.D. Transfemoral intraluminal graft implantation for abdominal aortic aneurysms.Ann Vasc Surg. 1991; 5: 491-499Abstract Full Text PDF PubMed Scopus (2972) Google Scholar and stages of his stent graft development as well as the group's lack of knowledge about the previous or simultaneous work of Volodos has been well documented.18Parodi J.C. Endoluminal treatment of arterial diseases using a stent-graft combination: reflections 20 years after the initial concept.J Endovasc Surg. 1997; 4: 3-4Crossref PubMed Scopus (17) Google Scholar, 19Criado F.J. EVAR at 20: the unfolding of a revolutionary new technique that changed everything.J Endovasc Ther. 2010; 17: 789-796Crossref PubMed Scopus (19) Google Scholar, 20Criado F.J. Nicholay Volodos and the origins of endovascular grafts.J Endovasc Ther. 2012; 19: 568-569Crossref PubMed Scopus (3) Google Scholar Others, like Lazarus21Lazarus HM, Inventor Intraluminal Graft Device, System and Method. United States patent 4,787,899 A, November 29, 1988.Google Scholar and Balko22Balko A. Piasecki G.J. Shah D.M. Carney W.I. Hopkins R.W. Jackson B.T. Transfemoral placement of intraluminal polyurethane prosthesis for abdominal aortic aneurysm.J Surg Res. 1986; 40: 305-309Abstract Full Text PDF PubMed Scopus (184) Google Scholar deserve at least some credit for this invention. Veith and Marin23Veith F.J. Marin M.L. Cynamon J. Schonholz C. Parodi J. 1992: Parodi, Montefiore, and the first abdominal aortic aneurysm stent graft in the United States.Ann Vasc Surg. 2005; 19: 749-751Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar, 24Veith F.J. Cynamon J. Schonholz C.J. Parodi J.C. Early endovascular grafts at Montefiore Hospital and their effect on vascular surgery.J Vasc Surg. 2014; 59: 547-550Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar were innovators who first recognised in the United States the importance of Parodi's invention and also deserve a lot of credit for dissemination of this revolutionary technology. There is no question now about the priority of Volodos who implanted the first stent graft in a patient's thoracic aorta as early as 1987 and developed a complex endovascular program by the end of the 1980s.25Bjorck M. The fall of a giant professor Nicolai Leontyevich Volodos, May 15, 1934–April 3, 2016.Eur J Vasc Endovasc Surg. 2016; : 3-4Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar, 26Svetlikov A.V. Unknown pages in the history of vascular stent grafting.J Vasc Surg. 2014; 59: 865-868Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar Parodi's accomplishments, however, should equally be recognised. Simultaneous inventions, frequently without knowledge of others' ideas, have been the fate and curse of inventors for centuries and raises questions as to whom the credit for an invention should go. Was it Isaac Newton or Gottfried Leibniz who invented the calculus? Was it Alexander Bell who invented the telephone or Elisha Gray, who applied for a patent the same day as Bell for basically the same invention? Is it Salk or Sabin who should be credited for inventing the vaccine for polio? Some of these questions can never be answered with certainty, but the end result is given: humanity benefited from many simultaneous inventions and all those who contributed, individuals or teams, should be honored. Our professional societies have been thoughtful in recognising and rewarding the greatest innovators, who gave so much to advance and transform the art and science of vascular surgery. Volodos was recognised at the Charing Cross meeting, received Honorary Fellowship of the European Society for Vascular Surgery, and carries the name of a Distinguished Lecture at the annual meeting.12Volodos N.L. The 30th Anniversary of the first clinical application of endovascular stent-grafting.Eur J Vasc Endovasc Surg. 2015; 49: 495-497Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar, 25Bjorck M. The fall of a giant professor Nicolai Leontyevich Volodos, May 15, 1934–April 3, 2016.Eur J Vasc Endovasc Surg. 2016; : 3-4Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar The Society for Vascular Surgery honored its greatest innovators, Juan Parodi, Timothy A.M. Chuter, Thomas Fogarty, Roy Greenberg, and Edward Dietrich with the Medal for Innovation in Vascular Surgery (Fig. 4). One may ask what motivated these surgeons to innovate? This question is best answered by Elon Musk, CEO of Space X and Tesla, who once said that "when something is important enough you do it even if the odds are against you." The odds of succeeding are against most innovators. The road is long from taking an idea through all phases of a device life cycle including prototype making, preclinical and clinical studies, manufacturing, marketing commercial use and post market studies (Fig. 5).27Iqbal C.W. Wall J. Harrison M.R. Challenges and climate of business environment and resources to support pediatric device development.Semin Pediatr Surg. 2015; 24: 107-111Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar It takes time, resources, expertise, one has to deal with complex regulations, long approval processes, patents, business models, and of course developing an invention needs funding.28Kramer D.B. Xu S. Kesselheim A.S. Regulation of medical devices in the United States and European Union.N Engl J Med. 2012; 366: 848-855Crossref PubMed Scopus (190) Google Scholar In the United States, medical innovations face major challenges. The most important of these are the sky rocketing costs, difficulty obtaining funding, complicated regulations and bureaucracy, inertia in the academic environment and a lack of mentorship.29Krummel T.M. Gertner M. Makower J. Milroy C. Gurtner G. Woo R. et al.Inventing our future: training the next generation of surgeon innovators.Semin Pediatr Surg. 2006; 15: 309-318Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar One of the main goals of the Fogarty institute for Innovation is to mentor young innovators to develop technologies that lower costs and improve patients' lives.30Fogarty Institute for Innovation www.fogartyinstitute.orgDate: 2018Google Scholar What are the solutions to these challenges? Innovators need to seek resources from their own institution, from Centres of Innovation, from the National Institute of Health, foundations, private investors, venture capitalists, industry partners, friends, patients, and patients' families. They also have to be very familiar with the regulatory process. Dr. Fogarty once said that "as innovators we break rules and we go against standards".30Fogarty Institute for Innovation www.fogartyinstitute.orgDate: 2018Google Scholar If you do that just be sure, as a Lancet editorial stated, that your medical innovation does not undermine the Hippocratic Oath.31Lancet O. Undermining the hippocratic oath: the medical innovation Bill.Lancet Oncol. 2015; 16: 1Abstract Full Text Full Text PDF PubMed Scopus (4) Google Scholar What does the Hippocratic Oath mean in 2017? The oath, found first on a 12th century byzantine manuscript, dates back to the 4th century bc. It is attributed to Hippocrates of Kos, also called the father of medicine, although it is very likely that it was written after his death by one of his student or followers (Fig. 6).32Bailey I. Who wrote the hippocratic oath?.West Engl Med J. 1991; 106: 91-92PubMed Google Scholar Key parts of the oath include that "I will do no harm or injustice to my patients. … I will neither give a deadly drug" and "What I may see or hear … I will keep to myself".33Tyson P. The hippocratic oath today.Nova. 2001; (accessed March 7, 2018)https://patents.google.com/patent/US4787899A/en?oq=us+patent+4%2c787%2c899Google Scholar The original version was not designed for surgeons, since it also included that "I will not use the knife". The oath was revised in the 1960s and this was somewhat kinder to our art, stating that "I will remember that warmth, sympathy, and understanding may outweigh the surgeon's knife." It also included that "above all, I must not play at God".33Tyson P. The hippocratic oath today.Nova. 2001; (accessed March 7, 2018)https://patents.google.com/patent/US4787899A/en?oq=us+patent+4%2c787%2c899Google Scholar The most recent version of the oath, based on the declaration of Geneva, avoids any reference to surgery and focuses on the health of the patient, that "will be my first consideration" and reinforces "the utmost respect to human life."34Parsa-Parsi R.W. The revised declaration of Geneva: a modern-day Physician's pledge.JAMA. 2017; 318: 1971-1972Crossref PubMed Scopus (101) Google Scholar After World War II, several codes have been published that defined medical ethics on patient care. It was the Belmont Report in 1979 that defined the ethical principles and provided guidelines for the protection of human subjects of research.35Protection of human subjects; Belmont Report: Notice of report for public comment.Fed Regist. 1979; 44: 23191-23197PubMed Google Scholar The Belmont report defined the boundaries between clinical practice, research and innovation, described how to protect the autonomy of the patient, stated the need for informed consent, and declared that researchers must be truthful and conduct no deception.35Protection of human subjects; Belmont Report: Notice of report for public comment.Fed Regist. 1979; 44: 23191-23197PubMed Google Scholar Today Institutional Review Boards or Ethics Boards in each hospital are charged with protecting the rights and welfare of human subjects involved in research. The main challenge is a conflict of interest and specifically so when the conflict is not declared. If there is a conflict then the care of the patient is influenced by a secondary interest. Conflict of interest may have multiple sources, well beyond financial gain; it may include peer pressure, fame, academic advancement, or an excessive desire to succeed. Innovation should never be a reckless experiment. Once hailed as a pioneer super-surgeon of regenerative medicine, Paolo Macchiarini implanted cadaver or prosthetic trachea, seeded with bone marrow or epithelial cells into at least 17 patients all around the world, 11 of whom had already died, while those alive have severe complications.36Rasko J. Power C. Dr Con Man: the Rise and Fall of a Celebrity Scientist Who Fooled Almost Everyone. The Guardian, 2017https://www.theguardian.com/science/2017/sep/01/paolo-macchiarini-scientist-surgeon-rise-and-fallGoogle Scholar He operated without well documented previous animal experiments, there was no ethics committee approval for most of his cases; patient misinformation and fake informed consent led to the downfall of this fake innovator.37McCook A. Swedish review Board Finds Misconduct by Macchiarini, Calls for Six Retractions. Retraction Watch, 2017https://retractionwatch.com/2017/10/30/swedish-review-board-finds-misconduct-macchiarini-calls-six-retractions/Google Scholar Evaluating surgical innovations has been a challenge for decades since the success of a procedure depends greatly on interventional skills, experience of the team and surgical judgment, and prospective randomised trials of new interventions have been difficult to initiate because of lack of equipoise of the interventionists. Evidence based evaluation of new procedures has however replaced clinical based evaluations and the rationale for a regulatory IDEAL framework (Idea Development Exploration Assessment Long-term study) to protect the patient and document safety and efficacy has been accepted by researchers and by regulatory agencies alike.38Barkun J.S. Aronson J.K. Feldman L.S. Maddern G.J. Strasberg S.M. Balliol Collaboration et al.Evaluation and stages of surgical innovations.Lancet. 2009; 374: 1089-1096Abstract Full Text Full Text PDF PubMed Scopus (417) Google Scholar, 39Ergina P.L. Cook J.A. Blazeby J.M. Boutron I. Clavien P.A. Reeves B.C. et al.Challenges in evaluating surgical innovation.Lancet. 2009; 374: 1097-1104Abstract Full Text Full Text PDF PubMed Scopus (457) Google Scholar Those who adopt surgical innovations also face multiple ethical challenges. Information on new devices is usually limited, adopters need to attend training courses, there is a need for a mentor, there is a learning curve, it is frequently only the inventor, and not the adopter, who has results of early experience and long-term results are usually not available. The core of surgical ethics is a special surgeon–patient relationship that those physicians who don't do interventions, do not fully understand. When a new procedure is introduced, the decision making must be shared between the surgeon and the patient. The surgeon must explain the risks and benefits of the procedure and it is the surgeon's responsibility to protect the well being of the patient.40Jones J.W. McCullough L.B. Richman B.W. The ethics of innovative surgical approaches for well-established procedures.J Vasc Surg. 2004; 40: 199-201Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar An editorial in the Lancet concluded that to provide the best care, we need ethical surgeons and well informed patients.41Angelos P. The ethical challenges of surgical innovation for patient care.Lancet. 2010; 376: 1046-1047Abstract Full Text Full Text PDF PubMed Scopus (55) Google Scholar It is not unusual that unnecessary and inappropriate procedures increase in numbers after approval of a new therapy. An example was provided by Peter Lawrence in his SVS presidential address where he noted that "it is hard to believe that a 4529% increase of venous ablation procedures during a 10 year period did not include a considerable number of over treatments."42Lawrence P.F. "Better" (sometimes) in vascular disease management.J Vasc Surg. 2016; 63: 260-269Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar A while back, endovascular treatment of abdominal aortic aneurysm was called a failed experiment.43Collin J. Murie J.A. Endovascular treatment of abdominal aortic aneurysm: a failed experiment.Br J Surg. 2001; 88: 1281-1282Crossref PubMed Scopus (101) Google Scholar In the early years there were too many secondary procedures and within 1 month of endoluminal AAA repair, 2–16% of patients required conversion to open operation. In an editorial, published in the Journal of Vascular Surgery, Veith and Johnston defended endovascular aneurysm repair.44Veith F.J. Johnston K.W. Endovascular treatment of abdominal aortic aneurysms: an innovation in evolution and under evaluation.J Vasc Surg. 2002; 35: 183Abstract Full Text Full Text PDF PubMed Scopus (15) Google Scholar "Just because an innovation is imperfect" they said "or has risks, does not mean it should be abandoned. Airplanes, jet engines, blood transfusions had early problems, yet all … proved advantageous. EVAR is not a failed experiment; it is an innovation in evolution and under evaluation." Time proved these authors were right. Surgical innovations are essential to advance cost-effective care and shared decision making on adopting new therapies by an ethical surgeon, and a well informed patient is the cornerstone of ethical patient care. Continuous re-evaluation of a new procedure, performing comparative studies, cost analysis, and providing long-term follow-up care are our responsibilities. We live in the era of accelerated innovations. "Never before in history has innovation offered promise of so much to so many in so short a time" said Bill Gates. Innovations have revolutionised surgical care: just compare the first operating room at St Mary's Hospital, in Rochester, Minnesota, where the Mayo brothers, William and Charles, performed cholecystectomies and gastric resections with today's sophisticated, hybrid endovascular suites, equipped with angiography, computed tomography and 3D fusion imaging, where complex thoraco-abdominal aortic aneurysms are repaired with endografts using percutaneous techniques (Fig. 7A,B). Today all vascular programs need innovators and innovation should be a part of every vascular unit, integrated closely with clinical practice, education and research. I have been blessed that during the past three decades I had the opportunity to witness the tremendous progress that has taken place in vascular and endovascular surgery, in great part because of revolutionary and disruptive innovations. It has also been a privilege of working with my colleagues and students and see our profession get stronger at the Mayo Clinic, from a section of five surgeons, when I joined in 1987, to the large family of surgeons, residents, researchers, and allied health personnel who belong to the Division of vascular and endovascular surgery today (Fig. 8A,B). It has been the most enjoyable journey of 30 years that I would not change for anything. I have also been most fortunate to have the best travel companion, my wife, Monika, and for her patience, love, and support, I am forever grateful. Finally, I would like to thank you for the honor and opportunity to deliver this lecture and remember professor Nicolai Leontyevich Volodos, a pioneer innovator and a giant in vascular surgery. None. None.
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