- Email: [email protected]
Karl Viktor Hall: From In Situ Vein Bypass to the Tilting Disc Heart Valve Prosthesis
OUR SURGICAL HERITAGE
Karl Viktor Hall: From In Situ Vein Bypass to the Tilting Disc Heart Valve Prosthesis John-Peder Escobar Kvitting, MD, PhD, and Odd R. Geiran, MD, PhD
MISCELLANEOUS
Department of Cardiothoracic Surgery, Oslo University Hospital Rikshospitalet, Oslo, Norway
In 1977, Karl Viktor Hall implanted a novel tilting disc heart valve prosthesis at Rikshospitalet in Oslo, Norway. The Medtronic-Hall valve was known for its excellent durability and low thrombogenicity. Hall popularized the use of the great saphenous vein in situ as an arterial shunt in the 1960s, made a metal stripper to lyse vein valves, and introduced electromagnetic flowmeters in vascular surgery. He performed the first coronary
artery bypass graft in Scandinavia in 1969. Under his leadership the first heart transplantation and the first heart-lung transplantation were performed in Scandinavia by his successor Tor Frøysaker in 1983 and 1986, respectively.
K
vaso vasorum of the vein remains intact, an aspect that has gained increased attention in recent years in coronary artery bypass graft (CABG) surgery using no-touch veins as conduits [3]. At that time, in January 1960, Karl Viktor Hall worked with Charles Rob as a visiting fellow, and performed his first operation using Rob’s method in the autumn of 1960. Unfortunately the operation was a failure and ended in amputation. Inspired by Rob’s novel approach using the in situ vein as an arterial shunt, Hall introduced a far more aggressive approach despite his early failure. The first operation using Hall’s approach was performed in February 1961. In 1962, Karl Viktor Hall published a paper in Surgery describing an approach in which the great saphenous vein is opened over each valve and the valve excised ad oculus (Fig 1A) [4]. In 1965 Karl Viktor Hall presented his doctoral thesis at the University of Oslo with the title “The great saphenous vein used in situ as an arterial shunt after vein valve extirpation,” in which he summarized the results of his first 90 cases (Fig 1B). Karl Viktor Hall later abandoned the individual incision approach and introduced instead a specially designed metal valve stripper in 1973 [5]. The valve stripper consists of two cylinders attached to a wire; the first part has the inverted imprint of a vein valve, and the second part stretches the vein. When the surgeon pulls on the wire, the first cylinder grasps the valve and destroys it (Fig 2). In a follow-up study of 251 cases of in situ bypass to the lower extremity in the treatment of femoropopliteal atherosclerotic disease, Hall and colleagues [6] reported that the patency rate was primarily dependent on the diameter of the vein. Karl Viktor Hall worked together with Hårek Hognestad and Christian Cappelen at the Norwegian Institute of Industrial Research, and there developed an electromagnetic square-wave flowmeter for use in vascular surgery [7]. The flowmeter became commercially available, and was marketed by the Nycotron Company, Norway. It became known internationally and was used
arl Viktor Hall was born June 19, 1917, in Tromsø, Norway. At the age of 11 he witnessed his father succumb to heart failure after an acute myocardial infarction while his mother, Margit, was away on a journey to southern Norway. Later, his mother was instrumental in encouraging the young Hall to pursue a career in medicine. During World War II, Hall just escaped the mass arrest of students by the Nazis in Oslo in 1942, and went into hiding for a few weeks before being smuggled over the border to Sweden. He enrolled in the Norwegian police force and served until the end of the war. After the war he resumed his medical studies and graduated from the University of Oslo in 1946. He married Inger Borgen in 1943, and they had 3 children. Karl Viktor Hall received his surgical training at district hospitals in Gjøvik, Oslo, and Molde before being appointed as a general surgeon at the Surgical Department A at Rikshospitalet (the National Hospital) in Oslo in 1956. Karl Viktor Hall received specialist certification in general, vascular, and thoracic surgery.
The Great Saphenous Vein Used In Situ as an Arterial Shunt After Vein Valve Extirpation For many years, the reversed great saphenous vein was used as a graft in the treatment of peripheral occlusive arterial disease, but the long-term results were poor. In 1959 Charles Rob, at St. Mary’s Hospital in London, introduced the principle of destroying the competence of valves with an internal vein stripper before suturing the vein in situ as an arterial shunt [1]. The in situ approach has several advantages, such as less mechanical trauma to the vein, reduced vasoconstriction, less risk of rotation, and improved flow compared with the reversed vein approach [2]. Furthermore, by leaving the vein in situ, the Address correspondence to Dr Kvitting, Department of Cardiothoracic Surgery, Oslo University Hospital Rikshospitalet, Oslo, Norway; email: [email protected].
Ó 2016 by The Society of Thoracic Surgeons Published by Elsevier
(Ann Thorac Surg 2016;102:1756–61) Ó 2016 by The Society of Thoracic Surgeons
0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2016.03.120
Ann Thorac Surg 2016;102:1756–61
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Fig 1. (A) A schematic drawing of the in situ vein bypass technique from Karl Viktor Hall’s publication in Surgery, 1962 (Reprinted with permission from Hall KV. The great saphenous vein used in situ as an arterial shunt after extirpation of the vein valves. A preliminary report. Surgery 1962;51:492-5.). (B) The cover page of Karl Viktor Hall’s doctoral thesis from 1965 (Reprinted with permission from Universitetsforlaget, Oslo, Norway.).
extensively to localize valves in the great saphenous vein during in situ bypass surgery.
Fig 2. The valvulotome developed by Karl Viktor Hall.
Rikshospitalet’s history of cardiac surgery dates back to Axel Cappelen’s suture of a stab wound in the free wall of the left ventricle on September 4, 1895 [8]. Cardiac surgery, however, first became a branch of general surgery in Norway in 1950. Professor Leif Efskind (1904–1987) was the head of Surgical Department A, and personally had extensive experience of closed mitral commissurotomy, when “open” heart surgery began in the late 1950s in Norway. The first clinical case, in 1957, was closure of an atrioseptal defect during deep hypothermia and in-flow occlusion. Two years later the first case using cardiopulmonary bypass, also closure of an atrioseptal defect, was performed [9]. It didn’t take long before Leif Efskind persuaded Karl Viktor Hall to move from vascular surgery to open heart surgery with the words, “You must leave vascular surgery to the others. From now on you will focus primarily on cardiac surgery, because you shall be my successor.” A momentous message for a young aspiring surgeon. In 1963 Karl Viktor Hall received a Fulbright scholarship and spent 6 months at Harvard Medical School in
MISCELLANEOUS
The Early Years of Cardiac Surgery at Rikshospitalet, Oslo, Norway
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Boston. During this trip to the United States he traveled with a $99 Greyhound ticket to San Francisco and attended the annual meeting of the American College of Surgeons. At this meeting Professor Albert Starr presented his first 60 patients using the cage-ball heart valve prosthesis. The next year Leif Efskind implanted the first Starr-Edwards valve (Edwards Lifesciences Corp, Irvine, CA) in the aortic position at Rikshospitalet. It soon became evident that the cage-ball valve prosthesis had unacceptable transvalvular pressure gradients, particularly with the small sizes, and many patients with a smallsized prosthesis were later reoperated on after introduction of the tilting disc valve. In December 1969, Karl Viktor Hall performed the first CABG operation in Scandinavia, and probably among the very first in Europe, with Professor Efskind as his first assistant. A short venous bypass was successfully joined to the right coronary artery. On the first postoperative day, however, the patient exhibited ventricular extrasystoles and subsequently died of ventricular fibrillation. In subsequent years, few procedures were performed as a result of skepticism in the cardiology community about the value and merits of CABG surgery, but with time CABG surgery became the dominant procedure at the department. The increasing volume of cardiac surgery owing to the introduction of CABG resulted in a long waiting list at Rikshospitalet. In the following years, Hall made substantial efforts to alleviate the discrepancy between the need to perform open heart surgery in Norway and the resources available. He supported the establishment of cardiac surgery at Ullevål hospital in Oslo in 1970, and a Norwegian government committee, chaired by Hall, recommended the further expansion of open heart surgery to regional centers in Bergen (1975), Tromsø (1978), and Trondheim (1983).
The Medtronic-Hall Tilting Disc Heart Valve Prosthesis In the early era of heart valve surgery in Oslo, cage-ball prostheses were implanted, resulting in poor hemodynamic results particularly with small sizes. This plus a high incidence of thromboembolic complications caused Karl Viktor Hall to switch to the tilting disc heart valve prosthesis. Karl Viktor Hall began using the Lillehei-Kaster valve in March 1970, and the tilting disc valve developed by Viking Olov Bj€ ork, in Stockholm, was introduced in Oslo 6 months later. Hall and his colleagues [10] later reported their experience with these two tilting disc designs in a randomized trial. Approximately 300 mitral valve prostheses and close to 200 aortic valve prostheses were studied, and this was among the first randomized trials in the field of prosthetic heart valve surgery in the world. Data and experience with these valves persuaded Hall to improve the tilting disc valve design. Hall approached the University of Minnesota, which owned the patent for the Lillehei-Kaster valve, suggesting improvements in their design, but this fell on barren earth. A frustrated Hall approached his friend Arne Wøien (1931–2006), who had helped Hall with the technical
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aspects of the electromagnetic flowmeter described earlier. Wøien was a physicist who later cofounded the medical company Vingmed, and provided the financial resources for the valve project with the statement “I’ll pay for the party.” Hall met with Robert L. Kaster (1933–2014) in the summer of 1976, and after several weekends of discussion that summer, they decided on a new design for the valve. Mr Arlen Johnson was contacted by Kaster and asked to construct the new mechanical heart valve. The prototypes were brought to Oslo, and Kaster, Hall, and Wøien were happy with the design of the valve. Mr Keith Johnson was contacted by Kaster to develop the prototypes that were later used in dog experiments in Oslo. The Medtronic company (Medtronic Inc, Minneapolis, MN) was contacted, and help was requested to assist Kaster to develop a facility for the manufacture of the Hall-Kaster valve commercially. At this time the US Food and Drug Administration (FDA) had become the US Government body in charge of overseeing the manufacturing and use of medical devices (including heart valve prostheses) after an act of US Congress on May 28, 1976. The data submitted to the FDA were based on pulse duplicator tests, in vitro experiments, and animal and clinical studies that were performed by Kaster in the United States and Hall and colleagues in Oslo. The application for approval of the Hall-Kaster valve was the first ever submitted to the agency. As a consequence, the FDA established a policy that the agency would never grant approval for a heart valve prosthesis without significant clinical research conducted according to a protocol decided by the FDA. Because the group behind the Hall-Kaster valve did not have sufficient resources to organize such a large clinical trial, the project was taken over by the Medtronic clinical study group who had extensive experience with clinical protocols as well as working with the FDA. Owing to the bureaucratic delay in the United States, clinical implantation of the valve was started in Oslo and other European centers. Medtronic’s interest in the Hall-Kaster valve dated back to one of Medtronic’s founders, Earl E. Bakken. To begin with, Medtronic had no heart valve prosthesis in their portfolio, but Bakken’s personal relationship with C. Walton Lillehei made Medtronic the natural partner to distribute the Lillehei-Kaster valve in many parts of the world. The Vingmed company in Scandinavia, founded by Arne Wøien, was also a distributor of the Lillehei-Kaster valve, and this led to the association between Bakken, Lillehei, Kaster, and Wøien. The original plan of the “troika” Wøien, Kaster, and Hall was to develop an improved tilting disc valve and to manufacture and sell the valve through Vingmed in Norway. However, after some tough negotiations, Medtronic became the owner of the valve project. The troika agreed that if the valve became a success, each member of the team should get what they desired most. In Hall’s case, his wish was to have his name on the valve and the prestige that followed. Not long after the deal between the troika and Medtronic, the name of the valve was changed to Medtronic-Hall in a marketing decision. The
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relationship between Karl Viktor Hall and Medtronic was basically mutual respect at a distance. Karl Viktor Hall’s major contribution to the sales efforts of the MedtronicHall valve was the conduct of a long-term clinical study and the publishing of several papers showing excellent results with the valve. The Medtronic-Hall valve had several important features making it a very promising tilting disc heart valve prosthesis. The rationale behind the design of the valve was that the tilting disc valve ensured minimal obstruction to forward flow, and that the disc guidance mechanism and the disc translation freedom improved the flow distribution in the major and minor orifices of the valve, with a maximum opening angle of 75 in the aortic position. These improvements made it particularly resistant to thrombosis and thromboembolic events. The Medtronic-Hall valve was made from a single piece of titanium with no welding (Fig 3A). This was a particularly important improvement compared with the Bj€ ork-Shiley convexo-concave valve. With more than 200,000 implants of the Medtronic-Hall valve, no case of mechanical failure has been described [11]. The disc was made of tungstenimpregnated graphite (making it radiopaque), and had a carbon pyrolytic coating. The suture ring of the valve was made of Teflon (knitted polytetrafluoroethylene; Fig 3B–3D). Teflon was used because this was believed to reduce the risk for thrombus formation. However, Teflon is inert, resulting in the absence of de novo endothelialization, making the Medtronic-Hall valve more prone to pannus formation, which could have affected the valve’s
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function [12]. Together with Wøien and Kaster, Hall reported the rationale behind the new tilting disc valve design in the Journal of the Oslo City Hospitals [13]. Before the first clinical implantation in man, approximately 40 dogs were operated on in the period 1976 to 1977 at the Institute for Surgical Research at Rikshospitalet. Kaster had also performed many pulse duplicator studies on different prototypes. The first patient to receive a valve was a 70-year-old man with aortic stenosis using a 23-mm valve. The first clinical data on implantation of the valve in the aortic and mitral positions were reported in 1979 [14, 15]. The Medtronic-Hall tilting disc valve was introduced the same year as the St. Jude Medical bileaflet valve (St. Jude Medical, Inc, St. Paul, MN). After the first implantation in 1977, the Medtronic-Hall valve was used exclusively at Rikshospitalet in Oslo until 1987, and was implanted in the aortic position in 1,104 patients [16]. After up to 25 years of follow-up, results have confirmed the durability and safety of the Medtronic-Hall valve, and have underlined the fact that patient-related factors are even more important for long-term survival and prognosis [17]. When comparing the St. Jude Medical bileaflet valve and the Medtronic-Hall valve, results have shown that these valves have similar clinical results in both the aortic and the mitral position [18]. Butchart and colleagues [19] reported similar excellent results using the Medtronic-Hall valve in 1,766 procedures (736 aortic, 796 mitral, and 234 double) with a total of 12,688 follow-up years. For patients with aortic stenosis without concomitant coronary artery disease, the 10-year survival rate was
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Fig 3. (A) The housing of the Medtronic-Hall tilting disc heart valve prosthesis is made from a single piece of titanium. The valve with the graphite disc and the Teflon sewing ring seen from the inflow (B), outflow (C), and lateral (D) positions.
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not significantly different from an age- and gendermatched general population [19]. These data also indicated that the use of low-dose anticoagulation did not increase the incidence of thromboembolic complications. This was probably attributable to efficient flushing of the Medtronic-Hall valve, reducing the risk for thrombus formation. The fact that the disc was lifted out of its housing and could rotate freely when open, for example, reduced thrombosis. The systolic flow profile in the ascending aorta is skewed toward the greater curvature with a right-handed helical pitch [20]. When implanted with the greater orifice of the tilting disc prosthetic heart valve against the annulus of the noncoronary sinus, the tilting disc had excellent flow characteristics [21]. When comparing the bileaflet valve with the tilting disc valve placed in optimal aortic positions, the tilting disc was associated with less turbulence and lower transvalvular pressure gradients. The clinical effect was more rapid and pronounced reduction of the mass of the interventricular septum when using the tilting disc valve compared with the bileaflet design, particularly noticeable in smaller-sized valves [22]. There were several reasons behind the removal of the Medtronic-Hall valve from the market. Sales, for instance, had fallen because of the overwhelming acceptance of bileaflet valves and bioprosthetic valves by the cardiac surgery community. Furthermore, structural failure of other mechanical valves raised concern about the potential liability of mechanical failure of the Medtronic-Hall valve, despite the fact that this was never reported [11].
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Rikshospitalet may be attributed to an already-established kidney transplant program, the recent introduction of cyclosporine (first discovered in a soil sample from Hardangervidda on the west coast of Norway in 1969), and a well-functioning laboratory for transplantation immunology headed by Professor Erik Thorsby. Tor Frøysaker, again assisted by Lindberg and Geiran, 2 younger surgeons trained at the department, also performed the first successful heart-lung en bloc transplantation in Scandinavia, on a patient with Eisenmenger syndrome, July 13, 1986. As of October 2015, a total of 874 heart, 27 heart-lung en bloc, and 476 lung transplantations have been performed at Rikshospitalet, Oslo. The long-term survival of heart transplantation has significantly improved during the last 10 years of the three decades that this procedure has been performed in Scandinavia [24].
Karl Viktor Hall—Surgical Innovator Karl Viktor Hall succeeded Professor Efskind to become full professor in 1974, and retired in 1987 (Fig 4). In 1987 Hall suffered an extensive myocardial infarction just before his retirement and was successfully operated on with CABG, by his apprentice Tor Frøysaker. Karl Viktor Hall’s professional career is best characterized by his many surgical innovations. He introduced new surgical techniques, but foremost he developed new
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The First Heart and Heart-Lung Transplantations in Scandinavia Karl Viktor Hall was one of 9 participants when the International Study Group for Cardiac Transplantation had its first meeting in Miami, November 17, 1980. In 1981 he organized a team of cardiologists, immunologists, and surgeons who were to perform the first heart transplantation in Norway. Hall sent his second-in-command, Tor Frøysaker (1929–1994), to Stanford University, Palo Alto, California, to gain knowledge and training from the team around Norman E. Shumway. Preclinical operations in pigs were also done at the Institute for Surgical Research at Rikshospitalet to prepare the team technically for surgery on both donor and recipient. The first heart transplant in Scandinavia was performed November 6, 1983. The donor was a patient with an intracranial hemorrhage, who died despite extensive neurointensive care treatment [23]. The recipient heart transplant patient is still alive and in good cardiac health more than 32 years after the index operation. Hall was in Madrid lecturing on the infection of heart valve prostheses, and was not present during the transplantation. At an early stage in the transplantation planning process, Hall had decided that Tor Frøysaker was to lead the multidisciplinary group at Rikshospitalet, because Hall was close to his retirement. Much of the early success of the heart transplantation program at
Fig 4. Karl Viktor Hall, professor of cardiothoracic surgery at the University of Oslo, 1974–1987.
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technical solutions such as the vein valve metal stripper, the flowmeter designed for vascular surgery, and the new tilting disc heart valve prosthesis. Hall was an eminent follower of the pragmatic philosophy that has been fundamental to the field of cardiovascular surgery since its early days [25]. Hall was an honorary member of the Nordic Surgical Society, the Nordic Society for Thoracic Surgery, and the International College of Angiology. Many young surgeons have benefitted from Hall’s great knowledge of circulatory physiology and surgery, and he had many dictums, among these being “You must always think about hemodynamics and flow when you sew the anastomosis.” Karl Viktor Hall died December 29, 2001. The authors are grateful for the historical information provided by Mr Keith Johnson on the development of the Medtronic-Hall valve.
References
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10. Nitter-Hauge S, Hall KV, Froysaker T, Efskind L. Aortic valve replacement: one-year results with Lillehei-Kaster and BjorkShiley disc prosthesis. A comparative clinical study. Am Heart J 1974;88:23–8. 11. Akins CW. Long-term results with the Medtronic-Hall valvular prosthesis. Ann Thorac Surg 1996;61:806–13. 12. Ellensen VS, Andersen KS, Vitale N, Davidsen ES, Segadal L, Haaverstad R. Acute obstruction by pannus in patients with aortic Medtronic-Hall valves: 30 years of experience. Ann Thorac Surg 2013;96:2123–8. 13. Hall KV, Kaster RL, Wøien A. An improved pivotal disc-type prosthetic heart valve. J Oslo City Hosp 1979;29:3–21. 14. Nitter-Hauge S, Enge I, Sembe BK, Hall KV. Primary clinical experience with the Hall-Kaster valve in the aortic position: results at 3 months including hemodynamic studies. Circulation 1979;60(2 Pt 2):55–62. 15. Nitter-Hauge S, Semb BK, Levorstad K, Rostad H, Hall KV. Primary results with the new Hall-Kaster disc valve prosthesis in mitral position. Thorac Cardiovasc Surg 1979;27: 85–91. 16. Svennevig JL, Abdelnoor M, Nitter-Hauge S. Twenty-fiveyear experience with the Medtronic-Hall valve prosthesis in the aortic position: a follow-up cohort study of 816 consecutive patients. Circulation 2007;116:1795–800. 17. Vlahakes GJ. Mechanical heart valves: the test of time.. Circulation 2007;116:1759–60. 18. Masters RG, Pipe AL, Walley VM, Keon WJ. Comparative results with the St. Jude Medical and Medtronic Hall mechanical valves. J Thorac Cardiovasc Surg 1995;110:663–71. 19. Butchart EG, Li HH, Payne N, Buchan K, Grunkemeier GL. Twenty years’ experience with the Medtronic Hall valve. J Thorac Cardiovasc Surg 2001;121:1090–100. 20. Segadal L, Matre K. Blood velocity distribution in the human ascending aorta. Circulation 1987;76:90–100. 21. Olin CL, Bomfim V, Halvazulis V, Holmgren AG, Lamke BJ. Optimal insertion technique for the Bj€ ork-Shiley valve in the narrow aortic ostium. Ann Thorac Surg 1983;36:567–76. 22. Kleine P, Hasenkam MJ, Nygaard H, Perthel M, Wesemeyer D, Laas J. Tilting disc versus bileaflet aortic valve substitutes: Intraoperative and postoperative hemodynamic performance in humans. J Heart Valve Dis 2000;9:308–12. 23. Frøysaker T, Foerster A, Forfang K, et al. Heart transplantation in Norway. One-year experience. Scand J Thorac Cardiovasc Surg 1985;19:193–7. 24. Dellgren G, Geiran O, Lemstr€ om K, et al. Nordic Thoracic Transplant Study Group. Three decades of heart transplantation in Scandinavia: long-term follow-up. Eur J Heart Fail 2013;15:308–15. 25. del Nido PJ. Surgical innovation: lessons from the pragmatic philosophical school. Ann Thorac Surg 2015;100: 778–83.
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1. Szilagyi DE, Smith RF, Elliott JP. Venous autografts in femoropopliteal arterioplasty. Observations in the treatment of occlusive disease. Arch Surg 1964;89:113–25. 2. Connolly JE. The history of the in situ saphenous vein bypass. J Vasc Surg 2011;53:241–4. 3. Dashwood MR, Savage K, Tsui JC, et al. Retaining perivascular tissue of human saphenous vein grafts protects against surgical and distension-induced damage and preserves endothelial nitric oxide synthase and nitric oxide synthase activity. J Thorac Cardiovasc Surg 2009;138:334–40. 4. Hall KV. The great saphenous vein used in situ as an arterial shunt after extirpation of the vein valves. A preliminary report. Surgery 1962;51:492–5. 5. Skagseth E, Hall KV. In situ vein bypass. Experiences with new vein valve strippers. Scand J Thorac Cardiovasc Surg 1973;7:53–8. 6. Hall KV, Alstrup P. The prognostic factors of arterialized bypass veins in the lower extremities. Ann Chir Gynaecol 1976;65:93–5. 7. Cappelen C Jr, Hall KV. Some observations on peripheral arterial flow by use of an electromagnetic flowmeter in arterial surgery. J Cardiovasc Surg (Torino) 1963;4:362–4. 8. Cappelen AH. Vulnus cordis. Sutur af hjertet [in Norwegian]. Norsk Mag Lægevidensk 1896;11:285–8. 9. Efskind L, Stensrud N, Cappelen C. Open heart surgery in atrial septal defects. Acta Chir Scand Suppl 1960;(Suppl 253): 107–10.
OUR SURGICAL HERITAGE
Karl Viktor Hall: From In Situ Vein Bypass to the Tilting Disc Heart Valve Prosthesis John-Peder Escobar Kvitting, MD, PhD, and Odd R. Geiran, MD, PhD
MISCELLANEOUS
Department of Cardiothoracic Surgery, Oslo University Hospital Rikshospitalet, Oslo, Norway
In 1977, Karl Viktor Hall implanted a novel tilting disc heart valve prosthesis at Rikshospitalet in Oslo, Norway. The Medtronic-Hall valve was known for its excellent durability and low thrombogenicity. Hall popularized the use of the great saphenous vein in situ as an arterial shunt in the 1960s, made a metal stripper to lyse vein valves, and introduced electromagnetic flowmeters in vascular surgery. He performed the first coronary
artery bypass graft in Scandinavia in 1969. Under his leadership the first heart transplantation and the first heart-lung transplantation were performed in Scandinavia by his successor Tor Frøysaker in 1983 and 1986, respectively.
K
vaso vasorum of the vein remains intact, an aspect that has gained increased attention in recent years in coronary artery bypass graft (CABG) surgery using no-touch veins as conduits [3]. At that time, in January 1960, Karl Viktor Hall worked with Charles Rob as a visiting fellow, and performed his first operation using Rob’s method in the autumn of 1960. Unfortunately the operation was a failure and ended in amputation. Inspired by Rob’s novel approach using the in situ vein as an arterial shunt, Hall introduced a far more aggressive approach despite his early failure. The first operation using Hall’s approach was performed in February 1961. In 1962, Karl Viktor Hall published a paper in Surgery describing an approach in which the great saphenous vein is opened over each valve and the valve excised ad oculus (Fig 1A) [4]. In 1965 Karl Viktor Hall presented his doctoral thesis at the University of Oslo with the title “The great saphenous vein used in situ as an arterial shunt after vein valve extirpation,” in which he summarized the results of his first 90 cases (Fig 1B). Karl Viktor Hall later abandoned the individual incision approach and introduced instead a specially designed metal valve stripper in 1973 [5]. The valve stripper consists of two cylinders attached to a wire; the first part has the inverted imprint of a vein valve, and the second part stretches the vein. When the surgeon pulls on the wire, the first cylinder grasps the valve and destroys it (Fig 2). In a follow-up study of 251 cases of in situ bypass to the lower extremity in the treatment of femoropopliteal atherosclerotic disease, Hall and colleagues [6] reported that the patency rate was primarily dependent on the diameter of the vein. Karl Viktor Hall worked together with Hårek Hognestad and Christian Cappelen at the Norwegian Institute of Industrial Research, and there developed an electromagnetic square-wave flowmeter for use in vascular surgery [7]. The flowmeter became commercially available, and was marketed by the Nycotron Company, Norway. It became known internationally and was used
arl Viktor Hall was born June 19, 1917, in Tromsø, Norway. At the age of 11 he witnessed his father succumb to heart failure after an acute myocardial infarction while his mother, Margit, was away on a journey to southern Norway. Later, his mother was instrumental in encouraging the young Hall to pursue a career in medicine. During World War II, Hall just escaped the mass arrest of students by the Nazis in Oslo in 1942, and went into hiding for a few weeks before being smuggled over the border to Sweden. He enrolled in the Norwegian police force and served until the end of the war. After the war he resumed his medical studies and graduated from the University of Oslo in 1946. He married Inger Borgen in 1943, and they had 3 children. Karl Viktor Hall received his surgical training at district hospitals in Gjøvik, Oslo, and Molde before being appointed as a general surgeon at the Surgical Department A at Rikshospitalet (the National Hospital) in Oslo in 1956. Karl Viktor Hall received specialist certification in general, vascular, and thoracic surgery.
The Great Saphenous Vein Used In Situ as an Arterial Shunt After Vein Valve Extirpation For many years, the reversed great saphenous vein was used as a graft in the treatment of peripheral occlusive arterial disease, but the long-term results were poor. In 1959 Charles Rob, at St. Mary’s Hospital in London, introduced the principle of destroying the competence of valves with an internal vein stripper before suturing the vein in situ as an arterial shunt [1]. The in situ approach has several advantages, such as less mechanical trauma to the vein, reduced vasoconstriction, less risk of rotation, and improved flow compared with the reversed vein approach [2]. Furthermore, by leaving the vein in situ, the Address correspondence to Dr Kvitting, Department of Cardiothoracic Surgery, Oslo University Hospital Rikshospitalet, Oslo, Norway; email: [email protected].
Ó 2016 by The Society of Thoracic Surgeons Published by Elsevier
(Ann Thorac Surg 2016;102:1756–61) Ó 2016 by The Society of Thoracic Surgeons
0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2016.03.120
Ann Thorac Surg 2016;102:1756–61
OUR SURGICAL HERITAGE
KVITTING AND GEIRAN KARL VIKTOR HALL
1757
Fig 1. (A) A schematic drawing of the in situ vein bypass technique from Karl Viktor Hall’s publication in Surgery, 1962 (Reprinted with permission from Hall KV. The great saphenous vein used in situ as an arterial shunt after extirpation of the vein valves. A preliminary report. Surgery 1962;51:492-5.). (B) The cover page of Karl Viktor Hall’s doctoral thesis from 1965 (Reprinted with permission from Universitetsforlaget, Oslo, Norway.).
extensively to localize valves in the great saphenous vein during in situ bypass surgery.
Fig 2. The valvulotome developed by Karl Viktor Hall.
Rikshospitalet’s history of cardiac surgery dates back to Axel Cappelen’s suture of a stab wound in the free wall of the left ventricle on September 4, 1895 [8]. Cardiac surgery, however, first became a branch of general surgery in Norway in 1950. Professor Leif Efskind (1904–1987) was the head of Surgical Department A, and personally had extensive experience of closed mitral commissurotomy, when “open” heart surgery began in the late 1950s in Norway. The first clinical case, in 1957, was closure of an atrioseptal defect during deep hypothermia and in-flow occlusion. Two years later the first case using cardiopulmonary bypass, also closure of an atrioseptal defect, was performed [9]. It didn’t take long before Leif Efskind persuaded Karl Viktor Hall to move from vascular surgery to open heart surgery with the words, “You must leave vascular surgery to the others. From now on you will focus primarily on cardiac surgery, because you shall be my successor.” A momentous message for a young aspiring surgeon. In 1963 Karl Viktor Hall received a Fulbright scholarship and spent 6 months at Harvard Medical School in
MISCELLANEOUS
The Early Years of Cardiac Surgery at Rikshospitalet, Oslo, Norway
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Boston. During this trip to the United States he traveled with a $99 Greyhound ticket to San Francisco and attended the annual meeting of the American College of Surgeons. At this meeting Professor Albert Starr presented his first 60 patients using the cage-ball heart valve prosthesis. The next year Leif Efskind implanted the first Starr-Edwards valve (Edwards Lifesciences Corp, Irvine, CA) in the aortic position at Rikshospitalet. It soon became evident that the cage-ball valve prosthesis had unacceptable transvalvular pressure gradients, particularly with the small sizes, and many patients with a smallsized prosthesis were later reoperated on after introduction of the tilting disc valve. In December 1969, Karl Viktor Hall performed the first CABG operation in Scandinavia, and probably among the very first in Europe, with Professor Efskind as his first assistant. A short venous bypass was successfully joined to the right coronary artery. On the first postoperative day, however, the patient exhibited ventricular extrasystoles and subsequently died of ventricular fibrillation. In subsequent years, few procedures were performed as a result of skepticism in the cardiology community about the value and merits of CABG surgery, but with time CABG surgery became the dominant procedure at the department. The increasing volume of cardiac surgery owing to the introduction of CABG resulted in a long waiting list at Rikshospitalet. In the following years, Hall made substantial efforts to alleviate the discrepancy between the need to perform open heart surgery in Norway and the resources available. He supported the establishment of cardiac surgery at Ullevål hospital in Oslo in 1970, and a Norwegian government committee, chaired by Hall, recommended the further expansion of open heart surgery to regional centers in Bergen (1975), Tromsø (1978), and Trondheim (1983).
The Medtronic-Hall Tilting Disc Heart Valve Prosthesis In the early era of heart valve surgery in Oslo, cage-ball prostheses were implanted, resulting in poor hemodynamic results particularly with small sizes. This plus a high incidence of thromboembolic complications caused Karl Viktor Hall to switch to the tilting disc heart valve prosthesis. Karl Viktor Hall began using the Lillehei-Kaster valve in March 1970, and the tilting disc valve developed by Viking Olov Bj€ ork, in Stockholm, was introduced in Oslo 6 months later. Hall and his colleagues [10] later reported their experience with these two tilting disc designs in a randomized trial. Approximately 300 mitral valve prostheses and close to 200 aortic valve prostheses were studied, and this was among the first randomized trials in the field of prosthetic heart valve surgery in the world. Data and experience with these valves persuaded Hall to improve the tilting disc valve design. Hall approached the University of Minnesota, which owned the patent for the Lillehei-Kaster valve, suggesting improvements in their design, but this fell on barren earth. A frustrated Hall approached his friend Arne Wøien (1931–2006), who had helped Hall with the technical
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aspects of the electromagnetic flowmeter described earlier. Wøien was a physicist who later cofounded the medical company Vingmed, and provided the financial resources for the valve project with the statement “I’ll pay for the party.” Hall met with Robert L. Kaster (1933–2014) in the summer of 1976, and after several weekends of discussion that summer, they decided on a new design for the valve. Mr Arlen Johnson was contacted by Kaster and asked to construct the new mechanical heart valve. The prototypes were brought to Oslo, and Kaster, Hall, and Wøien were happy with the design of the valve. Mr Keith Johnson was contacted by Kaster to develop the prototypes that were later used in dog experiments in Oslo. The Medtronic company (Medtronic Inc, Minneapolis, MN) was contacted, and help was requested to assist Kaster to develop a facility for the manufacture of the Hall-Kaster valve commercially. At this time the US Food and Drug Administration (FDA) had become the US Government body in charge of overseeing the manufacturing and use of medical devices (including heart valve prostheses) after an act of US Congress on May 28, 1976. The data submitted to the FDA were based on pulse duplicator tests, in vitro experiments, and animal and clinical studies that were performed by Kaster in the United States and Hall and colleagues in Oslo. The application for approval of the Hall-Kaster valve was the first ever submitted to the agency. As a consequence, the FDA established a policy that the agency would never grant approval for a heart valve prosthesis without significant clinical research conducted according to a protocol decided by the FDA. Because the group behind the Hall-Kaster valve did not have sufficient resources to organize such a large clinical trial, the project was taken over by the Medtronic clinical study group who had extensive experience with clinical protocols as well as working with the FDA. Owing to the bureaucratic delay in the United States, clinical implantation of the valve was started in Oslo and other European centers. Medtronic’s interest in the Hall-Kaster valve dated back to one of Medtronic’s founders, Earl E. Bakken. To begin with, Medtronic had no heart valve prosthesis in their portfolio, but Bakken’s personal relationship with C. Walton Lillehei made Medtronic the natural partner to distribute the Lillehei-Kaster valve in many parts of the world. The Vingmed company in Scandinavia, founded by Arne Wøien, was also a distributor of the Lillehei-Kaster valve, and this led to the association between Bakken, Lillehei, Kaster, and Wøien. The original plan of the “troika” Wøien, Kaster, and Hall was to develop an improved tilting disc valve and to manufacture and sell the valve through Vingmed in Norway. However, after some tough negotiations, Medtronic became the owner of the valve project. The troika agreed that if the valve became a success, each member of the team should get what they desired most. In Hall’s case, his wish was to have his name on the valve and the prestige that followed. Not long after the deal between the troika and Medtronic, the name of the valve was changed to Medtronic-Hall in a marketing decision. The
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relationship between Karl Viktor Hall and Medtronic was basically mutual respect at a distance. Karl Viktor Hall’s major contribution to the sales efforts of the MedtronicHall valve was the conduct of a long-term clinical study and the publishing of several papers showing excellent results with the valve. The Medtronic-Hall valve had several important features making it a very promising tilting disc heart valve prosthesis. The rationale behind the design of the valve was that the tilting disc valve ensured minimal obstruction to forward flow, and that the disc guidance mechanism and the disc translation freedom improved the flow distribution in the major and minor orifices of the valve, with a maximum opening angle of 75 in the aortic position. These improvements made it particularly resistant to thrombosis and thromboembolic events. The Medtronic-Hall valve was made from a single piece of titanium with no welding (Fig 3A). This was a particularly important improvement compared with the Bj€ ork-Shiley convexo-concave valve. With more than 200,000 implants of the Medtronic-Hall valve, no case of mechanical failure has been described [11]. The disc was made of tungstenimpregnated graphite (making it radiopaque), and had a carbon pyrolytic coating. The suture ring of the valve was made of Teflon (knitted polytetrafluoroethylene; Fig 3B–3D). Teflon was used because this was believed to reduce the risk for thrombus formation. However, Teflon is inert, resulting in the absence of de novo endothelialization, making the Medtronic-Hall valve more prone to pannus formation, which could have affected the valve’s
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function [12]. Together with Wøien and Kaster, Hall reported the rationale behind the new tilting disc valve design in the Journal of the Oslo City Hospitals [13]. Before the first clinical implantation in man, approximately 40 dogs were operated on in the period 1976 to 1977 at the Institute for Surgical Research at Rikshospitalet. Kaster had also performed many pulse duplicator studies on different prototypes. The first patient to receive a valve was a 70-year-old man with aortic stenosis using a 23-mm valve. The first clinical data on implantation of the valve in the aortic and mitral positions were reported in 1979 [14, 15]. The Medtronic-Hall tilting disc valve was introduced the same year as the St. Jude Medical bileaflet valve (St. Jude Medical, Inc, St. Paul, MN). After the first implantation in 1977, the Medtronic-Hall valve was used exclusively at Rikshospitalet in Oslo until 1987, and was implanted in the aortic position in 1,104 patients [16]. After up to 25 years of follow-up, results have confirmed the durability and safety of the Medtronic-Hall valve, and have underlined the fact that patient-related factors are even more important for long-term survival and prognosis [17]. When comparing the St. Jude Medical bileaflet valve and the Medtronic-Hall valve, results have shown that these valves have similar clinical results in both the aortic and the mitral position [18]. Butchart and colleagues [19] reported similar excellent results using the Medtronic-Hall valve in 1,766 procedures (736 aortic, 796 mitral, and 234 double) with a total of 12,688 follow-up years. For patients with aortic stenosis without concomitant coronary artery disease, the 10-year survival rate was
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Fig 3. (A) The housing of the Medtronic-Hall tilting disc heart valve prosthesis is made from a single piece of titanium. The valve with the graphite disc and the Teflon sewing ring seen from the inflow (B), outflow (C), and lateral (D) positions.
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not significantly different from an age- and gendermatched general population [19]. These data also indicated that the use of low-dose anticoagulation did not increase the incidence of thromboembolic complications. This was probably attributable to efficient flushing of the Medtronic-Hall valve, reducing the risk for thrombus formation. The fact that the disc was lifted out of its housing and could rotate freely when open, for example, reduced thrombosis. The systolic flow profile in the ascending aorta is skewed toward the greater curvature with a right-handed helical pitch [20]. When implanted with the greater orifice of the tilting disc prosthetic heart valve against the annulus of the noncoronary sinus, the tilting disc had excellent flow characteristics [21]. When comparing the bileaflet valve with the tilting disc valve placed in optimal aortic positions, the tilting disc was associated with less turbulence and lower transvalvular pressure gradients. The clinical effect was more rapid and pronounced reduction of the mass of the interventricular septum when using the tilting disc valve compared with the bileaflet design, particularly noticeable in smaller-sized valves [22]. There were several reasons behind the removal of the Medtronic-Hall valve from the market. Sales, for instance, had fallen because of the overwhelming acceptance of bileaflet valves and bioprosthetic valves by the cardiac surgery community. Furthermore, structural failure of other mechanical valves raised concern about the potential liability of mechanical failure of the Medtronic-Hall valve, despite the fact that this was never reported [11].
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Rikshospitalet may be attributed to an already-established kidney transplant program, the recent introduction of cyclosporine (first discovered in a soil sample from Hardangervidda on the west coast of Norway in 1969), and a well-functioning laboratory for transplantation immunology headed by Professor Erik Thorsby. Tor Frøysaker, again assisted by Lindberg and Geiran, 2 younger surgeons trained at the department, also performed the first successful heart-lung en bloc transplantation in Scandinavia, on a patient with Eisenmenger syndrome, July 13, 1986. As of October 2015, a total of 874 heart, 27 heart-lung en bloc, and 476 lung transplantations have been performed at Rikshospitalet, Oslo. The long-term survival of heart transplantation has significantly improved during the last 10 years of the three decades that this procedure has been performed in Scandinavia [24].
Karl Viktor Hall—Surgical Innovator Karl Viktor Hall succeeded Professor Efskind to become full professor in 1974, and retired in 1987 (Fig 4). In 1987 Hall suffered an extensive myocardial infarction just before his retirement and was successfully operated on with CABG, by his apprentice Tor Frøysaker. Karl Viktor Hall’s professional career is best characterized by his many surgical innovations. He introduced new surgical techniques, but foremost he developed new
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The First Heart and Heart-Lung Transplantations in Scandinavia Karl Viktor Hall was one of 9 participants when the International Study Group for Cardiac Transplantation had its first meeting in Miami, November 17, 1980. In 1981 he organized a team of cardiologists, immunologists, and surgeons who were to perform the first heart transplantation in Norway. Hall sent his second-in-command, Tor Frøysaker (1929–1994), to Stanford University, Palo Alto, California, to gain knowledge and training from the team around Norman E. Shumway. Preclinical operations in pigs were also done at the Institute for Surgical Research at Rikshospitalet to prepare the team technically for surgery on both donor and recipient. The first heart transplant in Scandinavia was performed November 6, 1983. The donor was a patient with an intracranial hemorrhage, who died despite extensive neurointensive care treatment [23]. The recipient heart transplant patient is still alive and in good cardiac health more than 32 years after the index operation. Hall was in Madrid lecturing on the infection of heart valve prostheses, and was not present during the transplantation. At an early stage in the transplantation planning process, Hall had decided that Tor Frøysaker was to lead the multidisciplinary group at Rikshospitalet, because Hall was close to his retirement. Much of the early success of the heart transplantation program at
Fig 4. Karl Viktor Hall, professor of cardiothoracic surgery at the University of Oslo, 1974–1987.
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technical solutions such as the vein valve metal stripper, the flowmeter designed for vascular surgery, and the new tilting disc heart valve prosthesis. Hall was an eminent follower of the pragmatic philosophy that has been fundamental to the field of cardiovascular surgery since its early days [25]. Hall was an honorary member of the Nordic Surgical Society, the Nordic Society for Thoracic Surgery, and the International College of Angiology. Many young surgeons have benefitted from Hall’s great knowledge of circulatory physiology and surgery, and he had many dictums, among these being “You must always think about hemodynamics and flow when you sew the anastomosis.” Karl Viktor Hall died December 29, 2001. The authors are grateful for the historical information provided by Mr Keith Johnson on the development of the Medtronic-Hall valve.
References
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10. Nitter-Hauge S, Hall KV, Froysaker T, Efskind L. Aortic valve replacement: one-year results with Lillehei-Kaster and BjorkShiley disc prosthesis. A comparative clinical study. Am Heart J 1974;88:23–8. 11. Akins CW. Long-term results with the Medtronic-Hall valvular prosthesis. Ann Thorac Surg 1996;61:806–13. 12. Ellensen VS, Andersen KS, Vitale N, Davidsen ES, Segadal L, Haaverstad R. Acute obstruction by pannus in patients with aortic Medtronic-Hall valves: 30 years of experience. Ann Thorac Surg 2013;96:2123–8. 13. Hall KV, Kaster RL, Wøien A. An improved pivotal disc-type prosthetic heart valve. J Oslo City Hosp 1979;29:3–21. 14. Nitter-Hauge S, Enge I, Sembe BK, Hall KV. Primary clinical experience with the Hall-Kaster valve in the aortic position: results at 3 months including hemodynamic studies. Circulation 1979;60(2 Pt 2):55–62. 15. Nitter-Hauge S, Semb BK, Levorstad K, Rostad H, Hall KV. Primary results with the new Hall-Kaster disc valve prosthesis in mitral position. Thorac Cardiovasc Surg 1979;27: 85–91. 16. Svennevig JL, Abdelnoor M, Nitter-Hauge S. Twenty-fiveyear experience with the Medtronic-Hall valve prosthesis in the aortic position: a follow-up cohort study of 816 consecutive patients. Circulation 2007;116:1795–800. 17. Vlahakes GJ. Mechanical heart valves: the test of time.. Circulation 2007;116:1759–60. 18. Masters RG, Pipe AL, Walley VM, Keon WJ. Comparative results with the St. Jude Medical and Medtronic Hall mechanical valves. J Thorac Cardiovasc Surg 1995;110:663–71. 19. Butchart EG, Li HH, Payne N, Buchan K, Grunkemeier GL. Twenty years’ experience with the Medtronic Hall valve. J Thorac Cardiovasc Surg 2001;121:1090–100. 20. Segadal L, Matre K. Blood velocity distribution in the human ascending aorta. Circulation 1987;76:90–100. 21. Olin CL, Bomfim V, Halvazulis V, Holmgren AG, Lamke BJ. Optimal insertion technique for the Bj€ ork-Shiley valve in the narrow aortic ostium. Ann Thorac Surg 1983;36:567–76. 22. Kleine P, Hasenkam MJ, Nygaard H, Perthel M, Wesemeyer D, Laas J. Tilting disc versus bileaflet aortic valve substitutes: Intraoperative and postoperative hemodynamic performance in humans. J Heart Valve Dis 2000;9:308–12. 23. Frøysaker T, Foerster A, Forfang K, et al. Heart transplantation in Norway. One-year experience. Scand J Thorac Cardiovasc Surg 1985;19:193–7. 24. Dellgren G, Geiran O, Lemstr€ om K, et al. Nordic Thoracic Transplant Study Group. Three decades of heart transplantation in Scandinavia: long-term follow-up. Eur J Heart Fail 2013;15:308–15. 25. del Nido PJ. Surgical innovation: lessons from the pragmatic philosophical school. Ann Thorac Surg 2015;100: 778–83.
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1. Szilagyi DE, Smith RF, Elliott JP. Venous autografts in femoropopliteal arterioplasty. Observations in the treatment of occlusive disease. Arch Surg 1964;89:113–25. 2. Connolly JE. The history of the in situ saphenous vein bypass. J Vasc Surg 2011;53:241–4. 3. Dashwood MR, Savage K, Tsui JC, et al. Retaining perivascular tissue of human saphenous vein grafts protects against surgical and distension-induced damage and preserves endothelial nitric oxide synthase and nitric oxide synthase activity. J Thorac Cardiovasc Surg 2009;138:334–40. 4. Hall KV. The great saphenous vein used in situ as an arterial shunt after extirpation of the vein valves. A preliminary report. Surgery 1962;51:492–5. 5. Skagseth E, Hall KV. In situ vein bypass. Experiences with new vein valve strippers. Scand J Thorac Cardiovasc Surg 1973;7:53–8. 6. Hall KV, Alstrup P. The prognostic factors of arterialized bypass veins in the lower extremities. Ann Chir Gynaecol 1976;65:93–5. 7. Cappelen C Jr, Hall KV. Some observations on peripheral arterial flow by use of an electromagnetic flowmeter in arterial surgery. J Cardiovasc Surg (Torino) 1963;4:362–4. 8. Cappelen AH. Vulnus cordis. Sutur af hjertet [in Norwegian]. Norsk Mag Lægevidensk 1896;11:285–8. 9. Efskind L, Stensrud N, Cappelen C. Open heart surgery in atrial septal defects. Acta Chir Scand Suppl 1960;(Suppl 253): 107–10.
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