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Surgery_Schwartz. human heart transplants began to reap-pear in the 1980s as a viable solution to end-stage heart failure. By 1981, the introduction of cyclosporin A finally created the necessary clinical immunologic modulation necessary to make long-term survival of heart recipients a reality.161Lung transplants have a similar history. In the 1950s, Metras in France and Hardin and Kittle in the United States performed canine lung transplants, demonstrating that meticu-lous anastomotic technique could produce normal pulmonary pressures. Hardy performed the first human lung transplant in 1963, although the patient lived only 18 days. The first suc-cessful long-term lung transplant was performed in 1983 in Toronto. These early lung recipients, however, were plagued by infection, rejection, and, most significantly, bronchial anas-tomotic dehiscence. Cooper and colleagues soon determined that the high-dose corticosteroids used for immunosuppression were responsible for the frequent occurrence of


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Surgery_Schwartz. significantly, bronchial anas-tomotic dehiscence. Cooper and colleagues soon determined that the high-dose corticosteroids used for immunosuppression were responsible for the frequent occurrence of dehiscence. The combination of high-dose corticosteroids and ischemic donor bronchi was deadly to lung recipients. Cooper, Morgan, and colleagues showed that the bronchial anastomosis could be pro-tected by wrapping it with a vascular omental pedicle, which not only provided neovascularity but also offered a buttress against any partial dehiscence.163Once cyclosporine became available for lung recipients, corticosteroid doses could be quickly tapered and stopped; cyclosporine poses no danger to the integrity of the bronchial anastomosis. In fact, the introduction of cyclosporine allowed the success of the first combined heart-lung transplant at Stanford in 1981 (after unsuccessful attempts by Cooley in 1969, Lillehei in 1970, and Barnard in 1981, all of whom used only high-dose


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Surgery_Schwartz. the success of the first combined heart-lung transplant at Stanford in 1981 (after unsuccessful attempts by Cooley in 1969, Lillehei in 1970, and Barnard in 1981, all of whom used only high-dose corticosteroids for immunosuppression). The 1980s marked the start of the modern age of thoracic transplants.Heart TransplantsIndications. The most common diagnosis leading to a heart transplant is ischemic dilated cardiomyopathy, which stems from coronary artery disease, followed by idiopathic dilated myopathy and congenital heart disease. About 3000 patients are added to the waiting list each year.Evaluation. Pretransplant, both candidates and potential donors are evaluated to ensure their suitability for the procedure. Transplant candidates undergo echocardiography, right and left heart catheterization, evaluation for any undiagnosed malignan-cies, laboratory testing to assess the function of other organs (such as the liver, kidneys, and endocrine system), a dental examination, psychosocial


Surgery_Schwartz

Surgery_Schwartz. evaluation for any undiagnosed malignan-cies, laboratory testing to assess the function of other organs (such as the liver, kidneys, and endocrine system), a dental examination, psychosocial evaluation, and appropriate screen-ing (such as mammography, colonoscopy, and prostate-specific antigen testing). Once the evaluation is complete, the selec-tion committee determines, at a multidisciplinary conference, whether or not a heart transplant is needed and is likely to be successful. Transplant candidates who meet all of the center’s criteria are added to the waiting list, according to the UNOS criteria, which are based on health status.Once a potential deceased donor is identified, the surgeon reviews the status report and screening examination results. The donor is initially matched to the recipient per the recipient’s status on the UNOS waiting list, the size match, and the blood type. Results of the donor’s serologic testing, echocardiography, chest X-ray, hemodynamic testing, and


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Surgery_Schwartz. recipient per the recipient’s status on the UNOS waiting list, the size match, and the blood type. Results of the donor’s serologic testing, echocardiography, chest X-ray, hemodynamic testing, and possibly coronary artery evaluation are assessed, in order to determine whether or not the donor’s heart can withstand up to 4 hours of cold ischemic time during procurement, transport, and surgery.Procedure. Heart transplants are most often performed ortho-topically (Fig. 11-25). The recipient’s native heart is removed, leaving the superior vena cava, the IVC, the left atrial cuff, the aorta, and the pulmonary artery in situ, in order to allow for anastomosis of the donor’s heart. Usually the left atrial cuff is anastomosed first, providing left heart inflow. Right heart inflow is achieved using a bicaval technique, by directly sew-ing the donor’s superior vena cava and IVC to the recipient’s venae cavae or by creating an anastomosis of the right atrium to a right atrial cuff. The donor’s


Surgery_Schwartz

Surgery_Schwartz. a bicaval technique, by directly sew-ing the donor’s superior vena cava and IVC to the recipient’s venae cavae or by creating an anastomosis of the right atrium to a right atrial cuff. The donor’s main pulmonary artery is con-nected to the recipient’s pulmonary artery, and finally, the aortic anastomosis is completed (Fig. 11-26).Once the cross-clamp is removed, the heart is allowed to receive circulation from the recipient and begins to function normally. Inotropic support with isoproterenol, dobutamine, or epinephrine is often required for 3 to 5 days, in order to support recovery from the cold ischemia.164On rare occasions, a heterotopic or “piggyback” heart can be transplanted, leaving the native heart in place. But this sce-nario is becoming very uncommon with the increasing use of mechanical circulatory support for single-ventricle failure.Posttransplant Care. Patient survival rates for heart recipients differ slightly after primary transplants vs. retransplants. In 2016, 3209


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Surgery_Schwartz. mechanical circulatory support for single-ventricle failure.Posttransplant Care. Patient survival rates for heart recipients differ slightly after primary transplants vs. retransplants. In 2016, 3209 heart transplants were performed in the United States. New, active listings increased 57% since 2005. Overall 1-year survival for patients who underwent heart transplant in 2009 to 2011 was 90.1%, 3-year survival was 83.5%, and 5-year Figure 11-25. A donor’s heart brought forward for anastomosis.Brunicardi_Ch11_p0355-p0396.indd 38901/03/19 6:55 PM 390BASIC CONSIDERATIONSPART IFigure 11-26. Suture lines for bicaval anastomosis (a), biatrial anastomosis (b), aortic anastomosis (c), and pulmonary artery anas-tomosis (d).aacbdsurvival was 78.3%, and the most common cause of death within the first year after transplant was infection.165 An increasing number of heart recipients have now survived more than 15 to 20 years with their first graft, especially those with no significant history of


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Surgery_Schwartz. year after transplant was infection.165 An increasing number of heart recipients have now survived more than 15 to 20 years with their first graft, especially those with no significant history of either cellular or antibody-mediated rejection.Heart recipients must be monitored for both early and late complications. Early complications include primary graft dys-function, acute cellular or antibody-mediated rejection, right heart failure secondary to pulmonary hypertension, and infec-tion. Hemodynamic values are monitored to assess early graft function; pharmacologic and sometimes mechanical support is instituted if needed.The goal of immunosuppression is to prevent rejection, which is assessed by immunosuppressive levels and, early on, by endomyocardial biopsy. Both T-cell–mediated (cellular) and B-cell–mediated (antibody-mediated) rejection are moni-tored. Most of the immunosuppression used is aimed at T cells; however, if the recipient has many preformed antibodies or develops


Surgery_Schwartz

Surgery_Schwartz. and B-cell–mediated (antibody-mediated) rejection are moni-tored. Most of the immunosuppression used is aimed at T cells; however, if the recipient has many preformed antibodies or develops donor-specific antibodies, other strategies (such as plasmapheresis or rituximab) are used to reduce the antibody load. Immunosuppressive regimens can vary by center, but most often consist of three categories of medications: a calcineurin inhibitor (usually tacrolimus or cyclosporine), an antiprolifera-tive agent (MMF or AZA), and a corticosteroid (prednisone). Other immunosuppressive agents can be used, depending on the needs of individual recipients.Recipients are also assessed for any infections, with visual inspection of wound healing and with monitoring of the com-plete blood count and cultures as needed. Other common early sequelae include drug-induced nephrotoxicity, glucose intoler-ance, hypertension, hyperlipidemia, osteoporosis, malignancies, and biliary disease.Late complications


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Surgery_Schwartz. as needed. Other common early sequelae include drug-induced nephrotoxicity, glucose intoler-ance, hypertension, hyperlipidemia, osteoporosis, malignancies, and biliary disease.Late complications include acquired transplant vasculopa-thy, progressive renal failure, and, most commonly, malignan-cies, especially skin cancer and PTLD. Accelerated coronary artery disease is the third most common cause of death posttrans-plant (after infections and acute rejection) and the most common cause after the first year. Coronary artery disease can begin to develop as early as 1 year posttransplant. Its pathogenesis is unknown, but it is believed to be immunologic. Because of these late complications, most transplant centers continue to perform screening tests and recipient examinations at least annually after the first year.Lung TransplantsIndications. The indications for a lung transplant include congenital disease, emphysema, COPD, cystic fibrosis, idio-pathic pulmonary fibrosis, primary


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Surgery_Schwartz. annually after the first year.Lung TransplantsIndications. The indications for a lung transplant include congenital disease, emphysema, COPD, cystic fibrosis, idio-pathic pulmonary fibrosis, primary pulmonary hypertension, α1-antitrypsin deficiency, and the need for a retransplant after primary graft failure. Each year in the United States, about 1600 patients are added to the waiting list; nearly a third of them have COPD and/or emphysema. The next most common diagnosis among patients on the waiting list is cystic fibrosis. A lung allo-cation score (LAS) was instituted in 2005. The average lung transplant candidate requires oxygen (often 4 L/min or more at rest) and has an extensively compromised quality of life, as documented by the results of pulmonary function and 6-minute walk tests.Evaluation. Evaluation for a lung transplant is very similar to evaluation for a heart transplant, except that lung transplant candidates undergo more extensive pulmonary function testing, a 6-minute


Surgery_Schwartz

Surgery_Schwartz. for a lung transplant is very similar to evaluation for a heart transplant, except that lung transplant candidates undergo more extensive pulmonary function testing, a 6-minute walk test, chest computed tomography, ventilation-perfusion (V-Q) scanning, and arterial blood gas assessment. In addition, all lung transplant candidates must have adequate cardiac function and must meet psychosocial requirements.Potential lung donors are also screened for blood type and size match. Larger lungs are accepted for COPD patients; smaller lungs are chosen for the restricted chest cavity of fibrotic patients. Donors should have a partial pressure of oxygen in arterial blood (Pao2) value >300 mmHg on a fraction of inspired oxygen (Fio2) of 100% and a positive end-expiratory pressure (PEEP) value of 5. Ideally, donors will have normal chest X-ray results, but exceptions for isolated abnormalities that will not affect subsequent graft function can be made. Living donors can donate a single lobe to a


Surgery_Schwartz

Surgery_Schwartz. Ideally, donors will have normal chest X-ray results, but exceptions for isolated abnormalities that will not affect subsequent graft function can be made. Living donors can donate a single lobe to a smaller recipient, such as a child. Single-lung transplants are common in many centers and can serve to increase the availability of lungs for multiple recipients. Newer concepts, such as “lung in the box” extracorporeal lung perfusion and stem cell technologies, may further improve the availability of donor lungs by optimizing the use of otherwise marginal grafts.Procedure. Lung transplants can be done either as (a) single-lung transplants (to either side via thoracotomy) or as (b) sequential bilateral-lung transplants (via bilateral thoracotomies or via a single clamshell incision that divides the sternum; Fig. 11-27). They can be done absent extracorporeal mechanical cardiopul-monary perfusion (bypass), with the lung with the worst func-tion (as predicted by preoperative ventilation


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Surgery_Schwartz. the sternum; Fig. 11-27). They can be done absent extracorporeal mechanical cardiopul-monary perfusion (bypass), with the lung with the worst func-tion (as predicted by preoperative ventilation and perfusion scanning) transplanted first. Despite careful surgical technique and excellent anesthesia, the poor pulmonary reserve of some lung recipients may require the institution of cardiopulmonary bypass to complete the transplant. Bypass is initiated through the chest by direct cardiac cannulation or peripherally via the femoral vessels.Once the thoracotomy is made, a recipient pneumonec-tomy is performed with care, in order to avoid injury to the phrenic or recurrent laryngeal nerves. The pulmonary veins and main pulmonary artery are encircled outside the peri-cardium. At this point, once the main pulmonary vessels are occluded, the need for cardiopulmonary bypass can be assessed. Brunicardi_Ch11_p0355-p0396.indd 39001/03/19 6:55 PM 391TRANSPLANTATIONCHAPTER 11Figure


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Surgery_Schwartz. point, once the main pulmonary vessels are occluded, the need for cardiopulmonary bypass can be assessed. Brunicardi_Ch11_p0355-p0396.indd 39001/03/19 6:55 PM 391TRANSPLANTATIONCHAPTER 11Figure 11-27. Clamshell incision. Bronchial anastomosis with ligated pulmonary arteries and veins.Figure 11-28. Bronchial anastomosis.The vessels and bronchus are ligated; the donor’s lung is pre-pared and brought to the table wrapped in cold iced gauze, in order to extend the cold preservation time. The bronchial anas-tomosis (Fig. 11-28) is performed first and then covered with peribronchial tissue or pericardium. The pulmonary artery and, finally, the vein are anastomosed. The lung is then de-aired before the final anastomotic suture is tightened, with gentle lung insufflation. All clamps are removed, and the lung is aerated. At least two chest tubes are left in place. After the transplant is complete, a bronchoscopy is performed to clear the airway of blood and secretions.Posttransplant


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Surgery_Schwartz. removed, and the lung is aerated. At least two chest tubes are left in place. After the transplant is complete, a bronchoscopy is performed to clear the airway of blood and secretions.Posttransplant Care. Patient survival rates for lung recipients vary significantly after primary vs. redo transplants. After pri-mary transplants, the patient survival rates at 1, 3, and 5 years are 83%, 62%, and 46%, respectively; after retransplants, the rates are 64%, 38%, and 28%.Postoperative care of lung recipients can be very labor-intensive. These patients require meticulous ventilator manage-ment, in order to maintain Fio2 at a minimum and to keep Pao2 at 70 mmHg. Most patients are extubated within the first 24 to 48 hours. Recipients can require multiple bronchoscopies for both airway management and surveillance biopsies. Diuretics are used generously to counteract any positive fluid balance from the operation and to help with pulmonary recovery.Early complications include technical


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Surgery_Schwartz. and surveillance biopsies. Diuretics are used generously to counteract any positive fluid balance from the operation and to help with pulmonary recovery.Early complications include technical complications, graft dysfunction, infections, and rejection. Technical complications often involve stenosis of one or more anastomoses leading to graft dysfunction. Bronchoscopy, V-Q scanning, echocardiogra-phy, and radiologic imaging are useful in identifying the causes of graft dysfunction. In up to 20% of recipients, primary early graft dysfunction can occur with no obvious cause. Such dys-function may be due to some pathology from the donor, perhaps an unknown aspiration, infection, or contusion; or it could result from poor graft preservation at the time of organ procurement. In the intensive care unit, aggressive ventilator and pharmaco-logic management can help, but recipients can nonetheless prog-ress to the need for mechanical support in the form of ECMO. Infections are treated with


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Surgery_Schwartz. care unit, aggressive ventilator and pharmaco-logic management can help, but recipients can nonetheless prog-ress to the need for mechanical support in the form of ECMO. Infections are treated with appropriate antibiotics, which can be challenging in patients with cystic fibrosis and a history of multidrug-resistant organisms. Rejection is monitored by biop-sies and treated as needed.Late complications include airway complications, such as strictures and, rarely, dehiscence, bronchiolitis obliterans, and malignancies. Strictures are treated with bronchoscopic dilation and intervention. Bronchiolitis obliterans often is a sequela of chronic rejection, but can be due to aspiration, chronic infec-tions, or various other causes. In recipients with a progressive fall in their forced expiratory volume in 1 second (FEV1), bron-chiolitis obliterans is suspected. All recipients should be taught to perform microspirometry at home as a screening tool post-transplant. Biopsies are performed to


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Surgery_Schwartz. volume in 1 second (FEV1), bron-chiolitis obliterans is suspected. All recipients should be taught to perform microspirometry at home as a screening tool post-transplant. Biopsies are performed to confirm the diagnosis of any complication and, if possible, the cause. Despite aggres-sive screening and treatment, more than 50% of recipients will develop graft dysfunction. Most if not all of the sequelae of chronic immunosuppression that occur in lung transplant recipi-ents are similar to those occurring in other groups of solid organ transplants.Heart-Lung TransplantsEvery year in the United States, 30 to 50 patients are added to the list of patients waiting to receive a simultaneous heart-lung transplant. The most common diagnosis is idiopathic pulmo-nary fibrosis, followed by primary pulmonary hypertension. Heart-lung candidates are often younger than their single-organ counterparts. The patient survival rates at 1, 3, and 5 years are 66%, 48%, and 39%, respectively. Often, lung


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Surgery_Schwartz. pulmonary hypertension. Heart-lung candidates are often younger than their single-organ counterparts. The patient survival rates at 1, 3, and 5 years are 66%, 48%, and 39%, respectively. Often, lung complications ultimately lead to graft failure. The immunosuppression is the same as that for single thoracic organ recipients, with emphasis on weaning the patient off corticosteroids as early as possible.XENOTRANSPLANTSXenotransplants (i.e., cross-species transplants of organs, tis-sues, or cells) have immense, yet untapped, potential to solve the critical shortage of available grafts. A primary hurdle is the formidable immunologic barrier between species, especially Brunicardi_Ch11_p0355-p0396.indd 39101/03/19 6:55 PM 392BASIC CONSIDERATIONSPART Iwith vascularized whole organs.161-170 Other problems include the potential risk of transmitting infections (known as zoono-ses or xenoses) and the ethical problems of using animals for widespread human transplants, even though great


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Surgery_Schwartz. Other problems include the potential risk of transmitting infections (known as zoono-ses or xenoses) and the ethical problems of using animals for widespread human transplants, even though great progress has been made in the past few years in efforts to overcome these problems.166-172Pigs are generally accepted as the most likely donor spe-cies for xenotransplants into human beings.173 Pigs would also be easier to raise on a large-scale basis. Guidelines for raising pigs in specialized facilities designated as pathogen-free have been established; in anticipation of clinical trials, such facilities have already been created and populated.171,172The immunologic barrier in pig-to-human xenotrans-plants is highly complex, but generally involves four subtypes of rejection.166 The first is hyperacute rejection (HAR), which is mediated by the presence of natural (preformed) xenoantibod-ies in humans. These antibodies bind to antigens found mainly on the vascular endothelial cells of porcine


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Surgery_Schwartz. rejection (HAR), which is mediated by the presence of natural (preformed) xenoantibod-ies in humans. These antibodies bind to antigens found mainly on the vascular endothelial cells of porcine donor organs, lead-ing to complement activation, intravascular coagulation, and rapid graft ischemia soon after the transplant. The second sub-type is acute humoral xenograft rejection (AHXR), a delayed form of antibody-mediated rejection seen in pig-to-nonhuman-primate transplants after steps to prevent HAR—steps such as depletion of antipig antibodies or complement from nonhu-man primates’ serum. Alternative names for AHXR include acute vascular rejection or delayed xenograft rejection. The third subtype is an acute cellular rejection process (similar to the classic T-cell–mediated acute rejection seen in allograft recipients). The fourth subtype is chronic rejection in grafts that survive for more than a few weeks (similar to the chronic rejection seen in long-surviving allograft recipients,


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Surgery_Schwartz. seen in allograft recipients). The fourth subtype is chronic rejection in grafts that survive for more than a few weeks (similar to the chronic rejection seen in long-surviving allograft recipients, with fea-tures of chronic vasculopathy).Many different options are being tested to overcome this immunologic barrier, including the genetic engineering of pigs, the use of agents to inhibit platelet aggregation and complement activation, and the administration of powerful immunosuppres-sive drugs.166-173During the first decade of the 21st century, the field of whole-organ xenotransplantation progressed significantly, thanks to the increasing availability of genetically engineered pigs and new immunosuppressive protocols. At a recent sympo-sium organized by the International Xenotransplantation Asso-ciation, data presented demonstrated extended survival time of porcine solid organs in nonhuman primates: from about 30 days to an average of 60 days and even up to 250 days (depending on the


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Surgery_Schwartz. Asso-ciation, data presented demonstrated extended survival time of porcine solid organs in nonhuman primates: from about 30 days to an average of 60 days and even up to 250 days (depending on the model).166,169,174,175 However, clinical application is still limited by thrombotic microangiopathy and consumptive coagu-lopathy; novel methods to prevent those complications will be required for further progress.Cellular xenotransplants have made great strides and are currently in the early stages of clinical trials. Porcine islet xenotransplants are the most advanced form; five independent groups have now demonstrated survival and function of porcine islets in nonhuman primates for more than 100 days.166,175-181 For the clinical trials, cost-benefit models have been developed, and the regulatory framework has been established.170-172,178 One trial of particular interest involves transplanting encapsulated porcine islets without immunosuppression.179 Early results are encouraging. But the


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Surgery_Schwartz. framework has been established.170-172,178 One trial of particular interest involves transplanting encapsulated porcine islets without immunosuppression.179 Early results are encouraging. But the efficacy of that approach may be limited until further genetic engineering enables proper oxygenation and nourishment of islet grafts, thereby supporting their viabil-ity and function.The future of xenotransplantation is exciting. Continued active research will focus on further genetic engineering of pigs, newer immunosuppressive drugs, and tissue engineering approaches that will minimize or eliminate the need for immu-nosuppression. Given recent progress, routine clinical applica-tion of cellular xenotransplants is likely within the next decade.REFERENCESEntries highlighted in bright blue are key references. 1. Carrel A. The surgery of blood vessels, etc. B Johns Hopkins Hosp. 1907;18:18-28. 2. Hamilton D, Reid, WA. Yu Yu Voronoy and the first human kidney allograft. Surg Gynecol Obstet.


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Surgery_Schwartz. key references. 1. Carrel A. The surgery of blood vessels, etc. B Johns Hopkins Hosp. 1907;18:18-28. 2. Hamilton D, Reid, WA. Yu Yu Voronoy and the first human kidney allograft. Surg Gynecol Obstet. 1984;159(3):289-294. 3. Medawar PB. Immunity to homologous grafted skin; the suppression of cell division in grafts transplanted to immu-nized animals. Br J Exp Pathol. 1946;27:9-14. 4. Merrill JP, Murray J, Harrison JH. Successful homotransplan-tation of the human kidney between identical twins. JAMA. 1956;160(4):277-282. 5. Murray JE, Merrill J, Harrison JH, et al. Prolonged sur-vival of human-kidney homografts by immunosuppressive drug therapy. N Engl J Med. 1963;268:1315-1323. 6. Starzl TE, Waddell WR, Marchioro TL. Reversal of rejection in human renal homografts with subsequent development of homograft tolerance. Surg Gynecol Obstet. 1963;117(4):385. 7. Calne RY, Rolles K, Thiru S, et al. Cyclosporin A initially as the only immunosuppressant in 34 recipients of cadav-eric organs: 32


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Surgery_Schwartz. of homograft tolerance. Surg Gynecol Obstet. 1963;117(4):385. 7. Calne RY, Rolles K, Thiru S, et al. Cyclosporin A initially as the only immunosuppressant in 34 recipients of cadav-eric organs: 32 kidneys, 2 pancreases, and 2 livers. Lancet. 1979;2(8151):1033-1036. 8. Hall BM, Dorsch S, Roser B. Cellular basis of allograft-rejection in vivo. 1. Cellular requirements for 1st set rejection of heart grafts. J Exp Med. 1978;148(4):878-889. 9. Hall BM, Dorsch S, Roser B. Cellular basis of allograft-rejection in vivo. 2. Nature of memory cells mediating second set heart graft rejection. J Exp Med. 1978;148(4):890-902. 10. Hariharan S, Johnson CP, Bresnahan BA, et al. Improved graft survival after renal transplantation in the United States, 1988 to 1996. N Engl J Med. 2000;342(9):605-612. 11. Cicciarelli J. Cyclosporine and trends in kidney transplanta-tion. Clin Transpl. 1986;6;223-320. 12. Meier-Kriesche HU, Li S, Gruessner RW, et al. Immuno-suppression: evolution in practice and trends,


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Surgery_Schwartz. J. Cyclosporine and trends in kidney transplanta-tion. Clin Transpl. 1986;6;223-320. 12. Meier-Kriesche HU, Li S, Gruessner RW, et al. Immuno-suppression: evolution in practice and trends, 1994-2004. Am J Transplant. 2006;6(5 Pt 2):1111-1131. 13. Halloran PF. Immunosuppressive drugs for kidney transplanta-tion. N Engl J Med. 2004;351(26):2715-2729. 14. Zand MS, Vo T, Huggins J, et al. Polyclonal rabbit antithy-mocyte globulin triggers B-cell and plasma cell apoptosis by multiple pathways. Transplantation. 2005;79(11):1507-1515. 15. Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006;355(19):1967-1977. 16. Vega O, Cardenas G, Correa-Rotter R, Alberu J, Morales-Buenrostro LE. Basilizimab vs. limited dose daclizumab (2 mg/kg) administered in single or two separated doses in kidney transplantation. Rev Invest Clin. 2008;60(2):82-86. 17. Kirk AD, Hale DA, Mann RB, et al. Results from a


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Surgery_Schwartz. vs. limited dose daclizumab (2 mg/kg) administered in single or two separated doses in kidney transplantation. Rev Invest Clin. 2008;60(2):82-86. 17. Kirk AD, Hale DA, Mann RB, et al. Results from a human renal allograft tolerance trial evaluating the humanized CD52-specific monoclonal antibody alemtuzumab (CAMPAH-1H). Transplantation. 2003;76(1):120-129. 18. Agarwal A, Shen LY, Kirk AD. The role of alemtuzumab in facilitating maintenance immunosuppression minimiza-tion following solid organ transplantation. Transpl Immunol. 2008;20(1-2):6-11. 19. Fryer JP, Granger DK, Leventhal JR, et al. Steroid-related complications in the cyclosporine era. Clin Transplant. 1994; 8:224.Brunicardi_Ch11_p0355-p0396.indd 39201/03/19 6:55 PM 393TRANSPLANTATIONCHAPTER 11 20. Humar A, Crotteau S, Gruessner A, et al. Steroid minimization in liver transplant recipients: impact on hepatitis C recurrence and posttransplant diabetes. Clin Transplant. 2007;21:526. 21. Matas AJ, Kandaswamy R, Gillingham


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Surgery_Schwartz. A, et al. Steroid minimization in liver transplant recipients: impact on hepatitis C recurrence and posttransplant diabetes. Clin Transplant. 2007;21:526. 21. Matas AJ, Kandaswamy R, Gillingham KJ, et al. Prednisone-free maintenance immunosuppression—a 5-year experience. Am J Transplant. 2005;5:2473. 22. Elion GB. The George Hitchings and Gertrude Elion Lecture. The pharmacology of azathioprine. Ann N Y Acad Sci. 1993; 685:400-407. 23. Remuzzi G, Lesti M, Gotti E, et al. Mycophenolate mofetil versus azathioprine for prevention of acute rejection in renal transplantation (MYSS): a randomized trial. Lancet. 2004;364:503. 24. Bolin P, Tanriover B, Zibari GB, et al. Improvement in 3-month patient-reported gastrointestinal symptoms after con-version from mycophenolate mofetil to enteric-coated myco-phenolate sodium in renal transplant patients. Transplantation. 2007;84(11):1443-1451. 25. Kaplan B, Schold J, Srinivas T, et al. Effect of sirolimus with-drawal in patients with deteriorating


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Surgery_Schwartz. myco-phenolate sodium in renal transplant patients. Transplantation. 2007;84(11):1443-1451. 25. Kaplan B, Schold J, Srinivas T, et al. Effect of sirolimus with-drawal in patients with deteriorating renal function. Am J Transpl. 2004;4(10):1709-1712. 26. Larson TS, Dean PG, Stegall MD, et al. Complete avoidance of calcineurin inhibitors in renal transplantation: a randomized trial comparing sirolimus and tacrolimus. Am J Transplant. 2006;6:514. 27. Burke JF, Pirsch JD, Ramos EL, et al. Long-term efficacy and safety of cyclosporine in renal transplant recipients. N Engl J Med. 1994;331:358. 28. Calne RY, Rolles K, White DJG, et al. Cyclosporin A initially as the only immunosuppressant in 34 recipients of cadaveric organs. Lancet. 1979;2:1033. 29. Sweny P, Farrington K, Younis F, et al. Sixteen months expe-rience with cyclosporin A in human kidney transplantation. Transplant Proc. 1981;13:365. 30. Mihatsch MJ, Kyo M, Morozumi K, et al. The side-effects of ciclosporine-A and tacrolimus.


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Surgery_Schwartz. months expe-rience with cyclosporin A in human kidney transplantation. Transplant Proc. 1981;13:365. 30. Mihatsch MJ, Kyo M, Morozumi K, et al. The side-effects of ciclosporine-A and tacrolimus. Clin Nephrol. 1998;49(6):356-363. 31. Larsen CP, Pearson TC, Adams AB, et al. Rational devel-opment of LEA29Y (belatacept), a high-affinity variant of CTLA4-Ig with potent immunosuppressive properties. Am J Transplant. 2005;5:443. 32. Vincenti F, Larsen C, Durrback A, et al. Costimulation block-ade with belatacept in renal transplantation. N Engl J Med. 2005;353;770. 33. Pescovitz MD. Rituximab, an anti-cd20 monoclonal anti-body: history and mechanism of action. Am J Transplant. 2006;6:859. 34. Blume OR, Yost SE, Kaplan B. Antibody-mediated rejection: pathogenesis, prevention, treatment, and outcomes. J Trans-plant. 2012:201754. 35. Becker YT, Becker BN, Pirsch JD, Sollinger HW. Rituximab as treatment for refractory kidney transplant rejection. Am J Transplant. 2004;4:996. 36. Perry DK, Burns


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Surgery_Schwartz. S, Tandon P, Gohel TD, et al. Current status of intestinal and multivisceral transplantation. Gastroenterol Rep. 2017;5(1):20-28. 156. Yersiz H, Renz JF, Hisatake GM, et al. Multivisceral and iso-lated intestinal procurement techniques. Liver Transplant. 2003;9(8):881-886. 157. Bueno J, Abu-Elmagd K, Mazariegos G, Madariaga J, Fung J, Reyes J. Composite liver–small bowel allografts with preser-vation of donor duodenum and hepatic biliary system in chil-dren. J Pediatr Surg. 2000;35(2):291-295; discussion 95-96. 158. Farmer DG, McDiarmid SV, Edelstein S, et al. Improved out-come after intestinal transplantation at a single institution over 12 years. Transplant Proc. 2004;36(2):303-304. 159. Tzakis AG, Kato T, Levi DM, et al. 100 multivisceral trans-plants at a single center. Ann Surg. 2005;242(4):480-490; dis-cussion 91-93. 160. Gruessner RWG, Sharp HL. Living related intestinal trans-plantation: first report of a standardized surgical tech-nique. Transplant.


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Surgery_Schwartz. center. Ann Surg. 2005;242(4):480-490; dis-cussion 91-93. 160. Gruessner RWG, Sharp HL. Living related intestinal trans-plantation: first report of a standardized surgical tech-nique. Transplant. 1997;64:1605-1607. 161. Kouchoukos NT, Blackstone EH, Doty DB. Heart failure. In: Kouchoukos NT, Blackstone EH, Doty DB, et al, eds. Cardiac Surgery. 3rd ed. New York: Kirklin/Barratt-Boyes; 2003:1725. 162. First human heart transplant. The History Channel website. Available at: https://www.history.com/this-day-in-history/first-human-heart-transplant. Accessed May 8, 2018. 163. Meyers BF, Patterson GA, Haverich A, Harringer W. Lung transplantation, heart-lung transplantation. In: Pearson FG, Cooper JD, Deslauriers J, et al, eds. Thoracic Surgery. 2nd ed. New York: Churchill-Livingston; 2002:1085-1131. 164. Costanzo MR, Dipchand A, Starling R, et al. The International Society of Heart and Lung Transplantation guidelines for care of heart transplant recipients. J Heart Lung Transplant.


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Surgery_Schwartz. MR, Dipchand A, Starling R, et al. The International Society of Heart and Lung Transplantation guidelines for care of heart transplant recipients. J Heart Lung Transplant. 2010;29(8):914-956. 165. Colvin M, Smith JM, Hadley N, et al. OPTN/SRTR 2016 annual data report: heart. Amer J Transplant. 2018;18(S1):291-362. 166. Esker B, Cooper DKC. Overcoming the barriers to xenotrans-plantation: prospects for the future. Exp Rev Clin Immunol. 2010;6(2):219-230. 167. Schuurman HJ. Xenotransplantation: from the lab to the clinic: Sunrise Symposium at the XXIII International Congress of the Transplantation Society, Vancouver, Canada, August 2010. Clin Transplant. 2011;25(4):E415-E421. 168. Dooldeniya MD, Warrens AN. Xenotransplantation: where are we today? J R Soc Med. 2003;96:111. 169. Thompson P, Badell IR, Lowe M, et al. Alternative immu-nomodulatory strategies for xenotransplantation: CD40/154 pathway-sparing regimens promote xenograft survival. Am J Transplant.


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Surgery_Schwartz. P, Badell IR, Lowe M, et al. Alternative immu-nomodulatory strategies for xenotransplantation: CD40/154 pathway-sparing regimens promote xenograft survival. Am J Transplant. 2012;12(7):1765-1775. 170. Hering BJ, Cooper DKC, Cozzi E, et al. The International Xenotransplantation Association consensus statement on con-ditions for undertaking clinical trials of porcine islet products in type I diabetes: executive summary. Xenotransplantation. 2009;16:196-202. 171. Schuurman HJ. Regulatory aspects of pig-to-human islet transplantation. Xenotransplantation. 2008;15(2):116-120. 172. Schuurman HJ. The International Xenotransplantation Associ-ation consensus statement on conditions for undertaking clini-cal trials of porcine islet products in type 1 diabetes—chapter 2: Source pigs. Xenotransplantation. 2009;16(4):215-222. 173. Meier RPH, Muller YD, Balaphas A, et al. Xenotransplanta-tion: back to the future? Transplant Int. 2017; doi: 10.1111/tri.13104. 174. Greenstein JL, Schuurman H-J. Solid


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Surgery_Schwartz. 2009;16(4):215-222. 173. Meier RPH, Muller YD, Balaphas A, et al. Xenotransplanta-tion: back to the future? Transplant Int. 2017; doi: 10.1111/tri.13104. 174. Greenstein JL, Schuurman H-J. Solid organ xenotransplantation: progress, promise, and regulatory issues. J Comm Biotech. 2001;8:15-29. 175. Thompson P, Badell IR, Lowe M, et al. Islet xenotransplanta-tion using gal-deficient neonatal donors improves engraftment and function. Am J Transplant. 2011;11:2593-2602. 176. Rood PPM, Cooper DKC. Islet xenotransplantation: are we really ready for clinical trials? Am J Transplant. 2006; 6(6):1269-1274. 177. Mihalicz D, Rajotte R, Rayat G. Porcine islet xenotransplan-tation for the treatment of type I diabetes. In: Type I Diabetes: Pathogenesis, Genetics and Immunotherapy. New York: InTech; 2011:479-502. 178. Beckwith J, Nyman JA, Flanagan B, et al. A health-economic anal-ysis of porcine islet xenotransplantation. Xenotransplantation. 2010;17:233-242. 179. Elliot RB, Living Cell


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Surgery_Schwartz. 2011:479-502. 178. Beckwith J, Nyman JA, Flanagan B, et al. A health-economic anal-ysis of porcine islet xenotransplantation. Xenotransplantation. 2010;17:233-242. 179. Elliot RB, Living Cell Technologies, Ltd. Towards xeno-transplantation of pig islets in the clinic. Curr Opin Organ Transplant. 2011;16(2):195-200. 180. Marigliano M, Bertera S, Grupillo M, et al. Pig-to-nonhuman primate pancreatic islet xenotransplantation: an overview. Curr Diab Rep. 2011;11(5):402-412. 181. Dufrane D, Gianello P. Pig islet for xenotransplantation in human: structural and physiological compatibility for human clinical application. Transplant Rev (Orlando). 2012;26:183-188.Brunicardi_Ch11_p0355-p0396.indd 39601/03/19 6:55 PM errors, observing that 34% of patients with health problems in the United States report experiencing medical, medication, or test errors—the highest rate of any nation, and an analysis sug-gests that the problem of medical care gone wrong, i.e., medical errors including


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Surgery_Schwartz. States report experiencing medical, medication, or test errors—the highest rate of any nation, and an analysis sug-gests that the problem of medical care gone wrong, i.e., medical errors including systems errors, may rank as the third leading cause of death in the United States.1Medical error is defined as an unintended act (either of omission or commission) or one that does not achieve its intended outcome, the failure of a planned action to be com-pleted as intended (an error of execution) or the use of a wrong plan to achieve an aim (an error of planning), and a deviation from the process of care, which may or may not cause harm to the patient. Medical error can occur at the individual provider level or at the system level. An expanding taxonomy is matur-ing to better categorize the types of factors and events that are avoidable. The role of error may be complex; error can some-times tragically end the life of a thriving person with a long life expectancy, or it can also accelerate


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Surgery_Schwartz. of factors and events that are avoidable. The role of error may be complex; error can some-times tragically end the life of a thriving person with a long life expectancy, or it can also accelerate an imminent death.The most commonly cited report on the incidence of deaths due to medical error, the 1999 Institute of Medicine (IOM) report, describes an incidence of 44,000 to 98,000 deaths annually.2 However, this estimate by the IOM was not based on primary research conducted by the IOM; rather, it was based on two older studies conducted in 1984 and 1992. Both studies were small and limited. In 2013, after compiling more recent evidence from multiple sources, James estimated an incidence range of 210,000 to 400,000 deaths a year associated with Quality, Patient Safety, Assessments of Care, and ComplicationsMartin A. Makary, Peter B. Angood, and Mark L. Shapiro 12chapterBackground 397Medical Care Gone Wrong / 397Unnecessary Medical Care / 398The Science of Patient Safety 399High


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Surgery_Schwartz. Care, and ComplicationsMartin A. Makary, Peter B. Angood, and Mark L. Shapiro 12chapterBackground 397Medical Care Gone Wrong / 397Unnecessary Medical Care / 398The Science of Patient Safety 399High Reliability Organizations / 399The Conceptual Model / 399Creating a Culture of Safety 400Assessing an Organization’s Safety Culture / 401Teamwork and Communication 402Measuring Teamwork / 402Communication Tools 402Operating Room Briefings (A Surgical Checklist) / 402Operating Room Debriefings / 403Sign Outs / 403Implementation / 403Comprehensive Unit-Based Safety Program 404Measuring Quality in Surgery 405Practice Pattern Measures / 405Agency for Healthcare Research and Quality Patient Safety Indicators / 406The Surgical Care Improvement Project Measures / 406National Surgical Quality Improvement Program / 407The Leapfrog Group / 408World Health Organization “Safe Surgery Saves Lives” Initiative / 408National Quality Forum / 408“Never Events” in Surgery 409Retained Surgical Items /


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Surgery_Schwartz. Program / 407The Leapfrog Group / 408World Health Organization “Safe Surgery Saves Lives” Initiative / 408National Quality Forum / 408“Never Events” in Surgery 409Retained Surgical Items / 409Surgical Counts / 410Wrong-Site Surgery / 411The Joint Commission Universal Protocol to Ensure Correct Surgery / 411Transparency in Healthcare 412Public Reporting and Patient Assessment of Care / 412Risk Management 413The Importance of Communication in Managing Risk / 413Complications 415Robotic Surgery / 415Complications in Minor Procedures / 415Organ System Complications / 418Wounds, Drains, and Infection / 424Nutritional and Metabolic Support Complications / 426Problems with Thermoregulation / 427BACKGROUNDPatient harm due to medical mistakes can be catastrophic, result-ing in high-profile consequences for the patient, surgeon, and institution. A single error can even destroy a surgeon’s career. While mistakes are inherent to human nature, it is becoming more recognized that many mistakes


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Surgery_Schwartz. for the patient, surgeon, and institution. A single error can even destroy a surgeon’s career. While mistakes are inherent to human nature, it is becoming more recognized that many mistakes are preventable.Patient safety is a science that promotes the use of evi-dence-based medicine and local wisdom to minimize the impact of human error on quality patient care. Wrong-site/wrong-procedure surgeries, retained sponges, unchecked blood transfusions, mismatched organ transplants, and overlooked allergies are all examples of potentially catastrophic events that can be prevented by implementing safer hospital systems. This chapter provides an overview of the modern-day field of patient safety by reviewing key measures of safety and quality, compo-nents of culture, interventions and tools, assessment methods, risk management strategies, and a selected review of common complications in surgery.Medical Care Gone WrongToday, there are more medications, diagnoses, procedures, and handoffs


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Surgery_Schwartz. assessment methods, risk management strategies, and a selected review of common complications in surgery.Medical Care Gone WrongToday, there are more medications, diagnoses, procedures, and handoffs performed than ever in the history of medicine. More-over, overtreatment is now an endemic problem in some areas of healthcare. With more medical care being delivered, there are naturally more opportunities for things to go wrong. In fact, harm may be associated with complexity. The Commonwealth Fund reported that the United States leads the world in medical 12Brunicardi_Ch12_p0397-p0432.indd 39720/02/19 3:57 PM 398Figure 12-1. Causes of death in the United States 2013. (Reproduced with permission from Makary MA, Daniel M. Medical error–the third leading cause of death in the US, BMJ. 2016 May 3;353:i2139.)Key Points1 Medical error ranks as the third leading cause of death in the United States when defined to include system errors.2 One form of medical error is unnecessary or excessive


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Surgery_Schwartz. May 3;353:i2139.)Key Points1 Medical error ranks as the third leading cause of death in the United States when defined to include system errors.2 One form of medical error is unnecessary or excessive medi-cal care, which represents 21% of medical care administered in the United States.3 New peer-comparison metrics evaluate appropriateness of surgical care by measuring a physician’s practice pattern among all the physician’s patients benchmarked to the phy-sician’s peers.4 Judicious opioid prescribing upon discharge after surgery is critical given the magnitude of the opioid crisis.5 The structure-process-outcome framework within the context of an organization’s culture helps to clarify how risks and hazards embedded within the organization’s structure may potentially lead to error and injure or harm patients.6 Poor communication contributes to approximately 60% of the sentinel events reported to The Joint Commission.7 Operating room briefings are team discussions of critical issues


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Surgery_Schwartz. or harm patients.6 Poor communication contributes to approximately 60% of the sentinel events reported to The Joint Commission.7 Operating room briefings are team discussions of critical issues and potential hazards that can improve the safety of the operation and have been shown to improve operating room culture and decrease operating room delays.8 National Quality Forum surgical “never events” include retained surgical items, wrong-site surgery, and death on the day of surgery of a normal healthy patient (American Soci-ety of Anesthesiologists Class 1).9 The most important determinant of malpractice claims against a surgeon is patient rapport, not undertesting.medical errors among hospital patients.3 Any point estimate in this range would rank the problem of dying from “medical care gone wrong” as the third leading cause of death in the United States. In caring for patients and considering the risks of tests and procedures done for borderline indications, it is important to


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Surgery_Schwartz. care gone wrong” as the third leading cause of death in the United States. In caring for patients and considering the risks of tests and procedures done for borderline indications, it is important to consider the magnitude of the problem of patients dying from the care they receive rather than from the disease or injury that brought them to care.Human error is inevitable. But while we cannot eliminate human error, we can better measure the problem to design safer systems mitigating its frequency, visibility, and consequences. Hospitals should consider the magnitude of the problem of med-ical error as a barrier to achieving safe, highly-reliable medical care. Investigating errors to learn from them can guide local changes to prevent future events. The strategy to rein in the endemic problem of death from medical care should include three areas: (a) make errors less frequent (by following prin-ciples that take human limitations into account); (b) make errors more visible when they occur


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Surgery_Schwartz. of death from medical care should include three areas: (a) make errors less frequent (by following prin-ciples that take human limitations into account); (b) make errors more visible when they occur so that their effects can be intercepted; and (c) have remedies at hand when errors affect a patient. This multitier approach necessitates guidance from reliable data.Unnecessary Medical CareIncreasingly preventable complications and complications from unnecessary procedures are considered to be forms of medical error. Unnecessary medical care accounts for an estimated $210 billion in excess spending each year, according to the National Academy of Medicine. The issue represents a significant oppor-tunity to make improve patient safety and lower healthcare Causes of death, US, 2013Based on our estimate,medical error is the3rd most commoncause of death in the USMedicalerror251 kCancer585 kHeartdisease611 kCOPD149 kAll causes2,597 kMotorvehicles34 kFirearms34 kSuicide41


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Surgery_Schwartz. US, 2013Based on our estimate,medical error is the3rd most commoncause of death in the USMedicalerror251 kCancer585 kHeartdisease611 kCOPD149 kAll causes2,597 kMotorvehicles34 kFirearms34 kSuicide41 kBrunicardi_Ch12_p0397-p0432.indd 39820/02/19 3:57 PM 399QUALITY, PATIENT SAFETY, ASSESSMENTS OF CARE, AND COMPLICATIONSCHAPTER 12costs. In a Johns Hopkins study, surveying over 2000 physicians in the United States, unnecessary medical care was reported to be common.4 On average, these authors reported that 21% of medical care is unnecessary. Breaking the problem down by type of medical care, the doctors reported that 22% of prescription medications, 25% of medical tests, and 11% of procedures are unnecessary. These perceptions by U.S. physi-cians validate previous estimates of the National Academy of Medicine that suggest that one-third of healthcare spending is wasteful and does not result in better health. Addressing avoid-able medical and surgical care is a topic gaining increasing


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Surgery_Schwartz. Academy of Medicine that suggest that one-third of healthcare spending is wasteful and does not result in better health. Addressing avoid-able medical and surgical care is a topic gaining increasing recog-nition in healthcare.One example of overtreatment in surgical care is opioid over-prescribing.5 In the United States in 2015 alone, clini-cians handed out 249 million opioid prescriptions, almost one for every American adult. And in 2016, the United States produced 14 billion opioid pills (40 for every American citizen). With the exception of pain specialists treating patients with pain syndromes, surgeons are the most common prescribers of opi-oids. Judicious opioid prescribing is important because of the addictive potential of these medications. Moreover, many patients can recover comfortably after hospital discharge with nonopioid or nonaddictive pain regimens.THE SCIENCE OF PATIENT SAFETYMedicine is considered a high-risk system with a high error rate, but these two


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Surgery_Schwartz. recover comfortably after hospital discharge with nonopioid or nonaddictive pain regimens.THE SCIENCE OF PATIENT SAFETYMedicine is considered a high-risk system with a high error rate, but these two characteristics are not always correlated. Other high-risk industries have managed to maintain an impeccably low error rate. For example, one of the highest risk systems in existence today, the U.S. Navy’s nuclear submarine program, has an unmatched safety record.Much of the credit for their safety record is due to the culture of the nuclear submarine program, with its insistence on individual ownership, responsibility, attention to detail, professionalism, moral integrity, and mutual respect.6 These characteristics have created the cultural context necessary for high-quality communications under high-risk, high-stress con-ditions. Each reactor operator is aware of what is going on at all times and is responsible for understanding the implications and possible consequences of any action.


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Surgery_Schwartz. high-risk, high-stress con-ditions. Each reactor operator is aware of what is going on at all times and is responsible for understanding the implications and possible consequences of any action. Communication flows freely between crewmen and officers, and information about any mistakes that occur are dispersed rapidly through the entire system so that other workers can learn how to prevent similar mistakes in the future.High Reliability OrganizationsThe nuclear submarine program is an example of an organi-zation that has achieved the distinction of being considered a “high reliability organization.” High reliability organization theory recognizes that there are certain high-risk industries and organizations that have achieved very low accident and error rates compared to what would be expected given the inherent risks involved in their daily operations. Other high reliability industries and organizations include aircraft carrier flight decks, nuclear power plants, and the Federal


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Surgery_Schwartz. expected given the inherent risks involved in their daily operations. Other high reliability industries and organizations include aircraft carrier flight decks, nuclear power plants, and the Federal Aviation Administration’s air traffic control system. In fact, one reason why nuclear power plants have such an excellent reliability record may be that their operators are often former naval submarine officers whose pre-vious experience and training within one highly reliable organi-zation are easily transferable to other organizations.7One of the assumptions underlying the science of high reliability organizations is that humans who operate and manage 34complex systems are themselves not sufficiently complex to sense and anticipate the problems generated by the system.7 This introduces another important idea undergirding the sci-ence of patient safety: the concept of normal accident theory. Instead of attributing accidents to individual error, this theory states that accidents are


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Surgery_Schwartz. another important idea undergirding the sci-ence of patient safety: the concept of normal accident theory. Instead of attributing accidents to individual error, this theory states that accidents are intrinsic to high-volume activities and even inevitable in some settings. Accidents should not be used merely to identify and punish the person at fault, but should be seen as a systems problem and addressed at a broader level. As Ruchlin states, even the “best people can make the worst errors as a result of latent conditions.”7High-risk systems, as defined by Perrow in 19848:• Have the potential to create a catastrophe, loosely defined as an event leading to loss of human or animal life, despoiling of the environment, or some other situation that gives rise to the sense of “dread.”• Are complex, in that they have large numbers of highly inter-dependent subsystems with many possible combinations that are nonlinear and poorly understood.• Are tightly coupled, so that any perturbation in the


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Surgery_Schwartz. in that they have large numbers of highly inter-dependent subsystems with many possible combinations that are nonlinear and poorly understood.• Are tightly coupled, so that any perturbation in the sys-tem is transmitted rapidly between subsystems with little attenuation.However, high reliability organization theory suggests that proper oversight of people, processes, and technology can handle complex and hazardous activities and keep error rates acceptably low.7 Studies of multiple high reliability organiza-tions show that they share the following common characteristics:• People are supportive of one another.• People trust one another.• People have friendly, open relationships emphasizing cred-ibility and attentiveness.• The work environment is resilient and emphasizes creativity and goal achievement, providing strong feelings of credibility and personal trust.Developing these characteristics is an important step toward achieving a low error rate in any organization. For this reason,


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Surgery_Schwartz. achievement, providing strong feelings of credibility and personal trust.Developing these characteristics is an important step toward achieving a low error rate in any organization. For this reason, safety culture is a measure used by hospitals nationwide to improve outcomes and is increasingly recognized as a metric of hospital quality.The Conceptual ModelThe Donabedian model of measuring quality identifies three main types of improvements: changes to organizational struc-ture, changes in organizational processes, and changes in outcomes.9 Structure refers to the physical and organiza-tional tools, equipment, and policies that improve safety. Struc-tural measures ask, “Do the right tools, equipment, and policies exist?” Process is the application of these tools, equipment, and policies/procedures to patients (good practices and evidence-based medicine). Process measures ask, “Are the right tools, policies, and equipment being used?” Outcome is the result on patients. Outcome


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Surgery_Schwartz. to patients (good practices and evidence-based medicine). Process measures ask, “Are the right tools, policies, and equipment being used?” Outcome is the result on patients. Outcome measures ask, “How often are patients harmed?” In this model, structure (how care is organized) plus process (what we do) influences patient outcomes (the results achieved).10The structure, process, and outcome components of qual-ity measurement all occur within the context of an organiza-tion’s overall culture. The local culture impacts all aspects of the delivery of care because it affects how front-line personnel 5Brunicardi_Ch12_p0397-p0432.indd 39920/02/19 3:57 PM 400BASIC CONSIDERATIONSPART ITable 12-1Types of medical errorAdverse event• Injury caused by medical management rather than the underlying condition of the patient• Prolongs hospitalization, produces a disability at discharge, or both• Classified as preventable or unpreventableNegligence• Care that falls below a recognized standard of


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Surgery_Schwartz. condition of the patient• Prolongs hospitalization, produces a disability at discharge, or both• Classified as preventable or unpreventableNegligence• Care that falls below a recognized standard of care• Standard of care is considered to be care a reasonable physician of similar knowledge, training, and experience would use in similar circumstancesNear miss• An error that does not result in patient harm• Analysis of near misses provides the opportunity to identify and remedy system failures before the occurrence of harmSentinel event• An unexpected occurrence involving death or serious physical or psychological injury• The injury involves loss of limb or function• This type of event requires immediate investigation and response• Other examples• Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities• Wrong-site, wrong-procedure, or wrong-patient surgery• A medication error or other treatment-related error resulting


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Surgery_Schwartz. of blood or blood products having major blood group incompatibilities• Wrong-site, wrong-procedure, or wrong-patient surgery• A medication error or other treatment-related error resulting in death• Unintentional retention of a foreign body in a patient after surgeryReproduced with permission from Makary M: General Surgery Review. Washington, DC: Ladner-Drysdale; 2008.Case 12-1 Systems change resulting from medical errorLibby Zion was an 18-year-old woman who died after being admitted to the New York Hospital with fever and agitation on the evening of October 4, 1984. Her father, Sidney Zion, a lawyer and columnist for the N.Y. Daily News, was convinced that his daughter’s death was due to inadequate staffing and overworked physicians at the hospital and was determined to bring about changes to prevent other patients from suffering as a result of the teaching hospital system. Due to his efforts to publicize the circumstances surrounding his daughter’s death, Manhattan District


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Surgery_Schwartz. changes to prevent other patients from suffering as a result of the teaching hospital system. Due to his efforts to publicize the circumstances surrounding his daughter’s death, Manhattan District Attorney Robert Morgenthau agreed to let a grand jury consider murder charges. Although the hospital was not indicted, in May 1986, a grand jury issued a report strongly criticizing “the supervision of interns and junior resi-dents at a hospital in NY County.”As a result, New York State Health Commissioner David Axelrod convened a panel of experts headed by Bertrand M. Bell, a primary care physician at Albert Einstein College of Medicine who had long been critical of the lack of supervision of physicians-in-training, to evaluate the training and supervision of doctors in New York State. The Bell Commission recom-mended that residents work no more than 80 hours per week and no more than 24 consecutive hours per shift, and that a senior physician needed to be physically present in the


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Surgery_Schwartz. The Bell Commission recom-mended that residents work no more than 80 hours per week and no more than 24 consecutive hours per shift, and that a senior physician needed to be physically present in the hospital at all times. These recommendations were adopted by New York State in 1989. In 2003, the Accreditation Council on Graduate Medi-cal Education followed by mandating that all residency training programs adhere to the reduced work hour schedule.understand and deliver safe patient care. In fact, culture (col-lective attitudes and beliefs of caregivers) is increasingly being recognized to be the fourth measurable component to the structure-process-outcome model. This recognition is based on growing evidence that local culture is linked to a variety of important clinical outcomes.10 For any new patient safety initiative to be deemed successful, any change in structure or process must lead to a corresponding positive change in patient outcomes.11CREATING A CULTURE OF SAFETYCulture is to


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Surgery_Schwartz. new patient safety initiative to be deemed successful, any change in structure or process must lead to a corresponding positive change in patient outcomes.11CREATING A CULTURE OF SAFETYCulture is to an organization what personality is to the individual—a hidden, yet unifying theme that provides meaning, direction, and mobilization.7 Organizations with effective safety cultures share a constant commitment to safety as a top-level priority that permeates the entire organization. These organizations fre-quently share the following characteristics12:• An acknowledgment of the high-risk, error-prone nature of an organization’s activities• A nonpunitive environment where individuals are able to report errors or close calls without fear of punishment or retaliation• An expectation of collaboration across ranks to seek solutions to vulnerabilities• A willingness on the part of the organization to direct resources to address safety concernsTraditional surgical culture stands almost in direct


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Surgery_Schwartz. across ranks to seek solutions to vulnerabilities• A willingness on the part of the organization to direct resources to address safety concernsTraditional surgical culture stands almost in direct oppo-sition to the values upheld by organizations with effective safety cultures for several reasons. Surgeons are less likely to acknowledge their propensity to make mistakes or to admit these mistakes to others.13 Surgeons tend to minimize the effect of stress on their ability to make decisions.14 The surgical cul-ture, especially in the operating room (OR), is traditionally rife with hierarchy. Intimidation of other OR personnel by sur-geons was historically accepted as the norm. This can prevent nurses and other OR staff from pointing out potential errors or Brunicardi_Ch12_p0397-p0432.indd 40020/02/19 3:57 PM 401QUALITY, PATIENT SAFETY, ASSESSMENTS OF CARE, AND COMPLICATIONSCHAPTER 12• I know the proper channels to direct questions regarding patient safety in this clinical area.• I


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Surgery_Schwartz. 40020/02/19 3:57 PM 401QUALITY, PATIENT SAFETY, ASSESSMENTS OF CARE, AND COMPLICATIONSCHAPTER 12• I know the proper channels to direct questions regarding patient safety in this clinical area.• I receive appropriate feedback about my performance.• I would feel safe being treated here as a patient.• In this clinical area, it is not difficult to discuss mistakes.Although perceptions of teamwork climate can differ as a function of one’s role in the OR, perceptions of safety climate are relatively consistent across OR providers in a given hospital. Validated in over 500 hospitals, the SAQ is used to establish benchmark safety culture scores by healthcare worker type, department, and hospital. Using this survey, hospitals can com-pare culture between different types of healthcare workers within a department as well as culture between departments throughout the institution. Scores can be compared to those of other par-ticipating institutions to compare safety climates. This allows


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Surgery_Schwartz. within a department as well as culture between departments throughout the institution. Scores can be compared to those of other par-ticipating institutions to compare safety climates. This allows hospitals to participate with one another to implement programs to improve safety culture. In addition, scores are used to evaluate the effectiveness of safety interventions by comparing the SAQ safety climate scores after implementation to baseline scores.Strong teamwork is at the core of any effective organiza-tion and is a key element to ensuring patient safety in the OR. Teamwork is dependent on the underlying culture and patterns of communication. The ability for all team members, to “speak up” about patient safety concerns is one of the most important elements of creating a culture of patient safety.TEAMWORK AND COMMUNICATIONAccording to The Joint Commission, communication breakdown is one of the top three root causes of sentinel events such as wrong-site surgery (Fig. 12-2). Poor


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Surgery_Schwartz. patient safety.TEAMWORK AND COMMUNICATIONAccording to The Joint Commission, communication breakdown is one of the top three root causes of sentinel events such as wrong-site surgery (Fig. 12-2). Poor communication contributed to over 60% of sentinel events reported to The Joint Commission in 2011.17 Good communication is an essential component of teamwork and is especially important in the OR, one of the most complex work environments in healthcare.Within the realm of patient care, there are enormous amounts of information being exchanged between healthcare pro-viders on a daily basis. Much of this information, if prioritized correctly, has the potential to prevent unintended medical errors and serious harm to patients. The importance of good communi-cation in preventing medical errors is undeniable; however, it is difficult to achieve. The traditional surgical hierarchy can prevent OR personnel from sharing important patient data and expressing safety concerns. One perioperative


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Surgery_Schwartz. is undeniable; however, it is difficult to achieve. The traditional surgical hierarchy can prevent OR personnel from sharing important patient data and expressing safety concerns. One perioperative field study showed a 30% rate of communication failure in the OR, with 36% of these break-downs having a substantial impact on patient safety.18In addition to overcoming the cultural barrier to better teamwork and communication, the prospective study by Chris-tian and associates of patient safety in the OR demonstrated that the standard workflow of the OR itself presents many opportunities for the loss or degradation of critical informa-tion.19 Hand-offs of patient care from the OR to other locations or providers are particularly prone to information loss, which has been demonstrated in other clinical settings. Hand-offs and auxiliary tasks, such as surgical sponge and instrument counts, frequently take place during critical portions of the case and place competing demands on provider


Surgery_Schwartz

Surgery_Schwartz. clinical settings. Hand-offs and auxiliary tasks, such as surgical sponge and instrument counts, frequently take place during critical portions of the case and place competing demands on provider attention from primary patient-centered activities. Communication between the surgeon and pathologist also is vulnerable because the communication often occurs through secondary messengers such as nurses or technicians. This information loss can lead to delays, overuse of 6Case 12-2 High-profile sentinel eventOn December 3, 1994, Betsy Lehman, a Boston Globe health columnist, died as a result of receiving four times the intended dose of chemotherapy for breast cancer. Remarkably, 2 days later, Maureen Bateman, a teacher being treated for cancer, also received a chemotherapy overdose and suffered irrevers-ible heart damage. After investigating the medication errors, the prescribing doctor, three druggists, and 15 nurses were disciplined by state regulators. The hospital was sued by the two


Surgery_Schwartz

Surgery_Schwartz. irrevers-ible heart damage. After investigating the medication errors, the prescribing doctor, three druggists, and 15 nurses were disciplined by state regulators. The hospital was sued by the two women’s families and by one of the doctors disciplined.As a result of this widely publicized event, the Dana-Farber Cancer Institute invested more than $11 million to overhaul their safety programs, including providing new training for their employees and giving doctors more time to meet with patients. The hospital adopted a full disclosure policy so that patients would be informed anytime a mistake had affected their care. Dana-Farber also started a patient com-mittee providing advice and feedback on ways to improve care at the hospital.mistakes. Moreover, this culture is not limited to the OR. In the intensive care unit (ICU), when compared to physicians, nurses reported more difficulty speaking up, disagreements were not appropriately resolved, and decisions were made without ade-quate


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Surgery_Schwartz. In the intensive care unit (ICU), when compared to physicians, nurses reported more difficulty speaking up, disagreements were not appropriately resolved, and decisions were made without ade-quate input.15 In addition, the field of medicine strongly values professional autonomy, which frequently promotes individual-ism over cooperation, often to the detriment of patient care.16 Finally, patient safety, although often viewed as important, is seldom promoted from an organizational priority to an organiza-tional value. Organizations often do not feel the need to devote resources to overhauling their patient safety systems as long as they perceive their existing processes to be adequate. It often takes a high-profile sentinel event to motivate leaders to com-mit the necessary time and resources to improving patient safety within their organization, as exemplified by the Dana-Farber Institute in the aftermath of Betsy Lehman’s death (Case 12-2).Assessing an Organization’s Safety


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Surgery_Schwartz. resources to improving patient safety within their organization, as exemplified by the Dana-Farber Institute in the aftermath of Betsy Lehman’s death (Case 12-2).Assessing an Organization’s Safety CultureEfforts to foster cultural change within an organization with regard to patient safety have been limited in the past by the inability to measure the impact of any given intervention. How-ever, studies have shown that employee attitudes about culture are associated with error reduction behaviors in aviation and with patient outcomes in ICUs. The Safety Attitudes Question-naire (SAQ) is a validated survey instrument that can be used to measure culture in a healthcare setting.9 Adapted from two safety tools used in aviation, the Flight Management Attitudes Questionnaire and its predecessor, the Cockpit Management Attitudes Questionnaire, the SAQ consists of a series of ques-tions measuring six domains: teamwork climate, safety climate, job satisfaction, perception of management, stress