Procedure-based complications to guide informed consent: analysis of society of thoracic surgeons-congenital heart surgery database.

SPECIAL REPORT

Procedure-Based Complications to Guide Informed Consent: Analysis of Society of Thoracic Surgeons-Congenital Heart Surgery Database Constantine Mavroudis, MD, Constantine D. Mavroudis, MD, Jeffrey P. Jacobs, MD, Allison Siegel, MSSA, Sara K. Pasquali, MD, Kevin D. Hill, MD, and Marshall L. Jacobs, MD Johns Hopkins Children’s Heart Surgery, Florida Hospital for Children, Orlando, Florida; Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania; Johns Hopkins Children’s Heart Surgery, All Children’s Hospital, St. Petersburg, Florida; Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor, Michigan; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina; and Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland

REPORT

Background. Informed consent refers to the process by which physicians and patients engage in a dialogue to explain and comprehend the nature, alternatives, and risks of a procedure or course of therapy. The goal of this study is to better “inform the process of informed consent” by offering empirically derived procedural complication lists that provide objective contemporary data that surgeons may share with patients and families. Methods. The Society of Thoracic Surgeons Congenital Heart Surgery Database was queried for complications for 12 congenital heart operations (2010 to 2011) performed across all Society of Thoracic Surgeons-European Association of Cardio-Thoracic Surgery Congenital Heart Surgery (STAT) risk categories. Results. The 12 index procedures reviewed for rates of complications were repair of atrial septal defect (ASD), ventricular septal defect (VSD), atrioventricular septal defect (AVSD), tetralogy of Fallot (TOF), coarctation, and truncus arteriosus, as well as arterial switch operation (ASO), ASO-VSD, BiGlenn, Fontan, Norwood procedure, and systemic to pulmonary artery (S-P) shunt.

Arrhythmia was the most frequent complication for VSD (5.8%), TOF (8.9%), and AVSD (14.7%) repairs. There was a high rate of sternum left open (planned, unplanned) for ASO (26%, 7%), ASO-VSD (29%, 10%), truncus repair (41%, 11%), and Norwood (63%, 7%). The most frequent complications for other procedures include ASD (unplanned readmission, 1.9%), BiGlenn (chylothorax, 7%), Fontan (pleural effusion, 16%), S-P shunt (reintubation, 10.6%), and coarctation (reintubation, 5.2%). Conclusions. The informed consent process for congenital heart surgery may be served by accurate contemporary data on occurrence of complications. While a threshold rate of occurrence of individual complications may guide the physician, rare but important debilitating complications should also be discussed irrespective of frequency. We propose to better inform the process of informed consent by providing objective complications data.

I

considers cultural diversity, language barriers, psychologic temperaments, socioeconomic conditions, and patient autonomy [2, 3]. Informed consent as a process was first introduced in the case of Salgo v. Leland Stanford Jr. University Board of Trustees [4]. In support of the litigants who claimed that physicians were not adequately performing their duty of responsible and adequate behaviors in their interactions with patients, the court ruled that “a physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment” [4]. Subsequent court rulings have refined and clarified the legal concept of informed consent by broadening the scope from professional to patient-oriented standards [2] in order to further emphasize the tenets of autonomy, nonmalfeasance, beneficence, and justice.

nformed consent refers to a process by which physicians and patients engage in a dialogue to explain and comprehend the nature, alternatives, and risks of a procedure or course of therapy. In particular, most patients want to learn about the disease entity, its natural history, proposed operation, experience of the surgeon and team, reasonable alternatives, and the risks, including complications and mortality. The legal and moral tenets hold that the patient is responsible for her own autonomy and is free to “make medical decisions that reflect her beliefs and healthcare needs” [1]. It is assumed that this dialogue

Accepted for publication Dec 17, 2013. Presented at the Sixtieth Annual Meeting of the Southern Thoracic Surgical Association, Scottsdale, AZ, Oct 30–Nov 2, 2013. Address correspondence to Dr Mavroudis, Johns Hopkins Children’s Heart Surgery, Florida Hospital for Children, 2501 N Orange Ave, Ste 540, Orlando, FL 32804; e-mail: constantine.mavroudis.md@flhosp.org.

Ó 2014 by The Society of Thoracic Surgeons Published by Elsevier Inc

(Ann Thorac Surg 2014;97:1838–51) Ó 2014 by The Society of Thoracic Surgeons

0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2013.12.037

Ann Thorac Surg 2014;97:1838–51

SPECIAL REPORT MAVROUDIS ET AL INFORMED CONSENT FOR CHS

ASD ASO AVC AVSD BBDCPA

= = = = =

BDCPA

=

CAVSD

=

CPS ECMO

= =

IABP MBTS MI MODS MSOF PA RV S-P STAT

= = = = = = = = =

STS-CHSDB = TCPC TOF VAD VSD

= = = =

atrial septal defect arterial switch operation atrioventricular canal atrioventricular septal defect bilateral bidirectional cavopulmonary anastomosis or bilateral bidirectional Glenn bidirectional cavopulmonary anastomosis or bidirectional Glenn complete atrioventricular septal defect cardiopulmonary support extracorporeal membrane oxygenation intraaortic balloon pump modified Blalock Taussig shunt myocardial infarction multi-organ dysfunction syndrome multi-system organ failure pulmonary artery right ventricle systemic to pulmonary artery Society of Thoracic SurgeonsEuropean Association of CardioThoracic Surgery Congenital Heart Surgery risk categories Society of Thoracic Surgeons Congenital Heart Surgery Database total cavopulmonary connection tetralogy of Fallot ventricular assist device ventricular septal defect

The practice of informed consent is far from standardized [1]. The discussion between patients or parents and physicians largely depends on the informing physician’s knowledge of potential complications and interactive skills. These skills have been developed in the course of medical education and instantiated by role models who have taken the time to instill compassion, competence, and duty. In some instances, the informed consent process has been influenced by principles that apply to controlled, randomized, prospective clinical studies that demand certain identifiable consent processes, usually documented with comprehensive preprinted forms that have been vetted by Institutional Review Boards [2]. The actual physician-patient interaction has not been emphasized, allowing the process to continue under the amorphous scope of “the art of medicine.” Several authors [5, 6] have undertaken questionnaire studies that have chronicled physician opinion and offered suggestions, based in part on the occurrence of complications, which may guide the interaction between physician and patient. There remain significant uncertainties as to what complications should be mentioned in the informed consent process. Analysis of data in the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSDB) [7] provides important information concerning occurrence rates of a group of 6

major complications that are generally but not always specifically discussed with patients and families. How and why physicians choose from the myriad of recognized complications in order to properly perform informed consent is unknown. The informed consent process affords an opportunity to establish a personal relationship with the patient and to review the treatment plan, reveal reasonable expectations, instill confidence, project hope, and assure that complications, if they occur, will be treated in a compassionate and expeditious manner [8]. It is the “reasonable expectations” portion of this process that we address by collating objective data to inform the informed consent process for congenital heart operations. The purpose of this study is to query the STS-CHSDB for the rates of occurrence of complications for 12 common operations, to review the literature, and to opine on the nature and process of informed consent as it applies to congenital heart surgeons.

Material and Methods The STS-CHSDB was queried for complications (Table 1) for 12 congenital heart operations performed across all Society of Thoracic Surgeons-European Association of Cardio-Thoracic Surgery Congenital Heart Surgery (STAT) risk categories [9]. Table 2 lists these 12 operations and the STS-CHSDB procedures included in each group. All patients undergoing operations in one of the 12 procedural groups during 2010 and 2011 were eligible for inclusion in the analysis. Patients with missing data on hospital discharge status or complications were excluded from analysis, as were centers with greater than 15% missing data for complications. Standard STS-CHSDB definitions (STS-CHSDB Version 3.0) are used for the individual complications coded in the STS-CHSDB. In this study, analysis of the rates of the 6 major complications that contribute to the STS Morbidity Score [7] is likewise based on STS-CHSDB Version 3.0 codes. Summary statistics were expressed as counts and percentage frequency of occurrence for the indicated procedures.

Results Tables 3 to 14 list complications that occurred in greater than 0.5% of patients undergoing these 12 types of operations. Arrhythmia was the most frequent complication for ventricular septal defects (VSD; 6%), tetralogy of Fallot (9%), and atrioventricular septal defect (15%) repairs. There was a high rate of sternum left open (planned, unplanned) for arterial switch operation (ASO; 26%, 7%), ASO-VSD (29%, 10%), truncus repair (41%, 11%), and Norwood (63%, 7%). The most frequent complications for other procedures include the following: atrial septal defect (unplanned readmission, 2%), BiGlenn (chylothorax, 7%), Fontan (pleural effusion, 16%), systemic to pulmonary artery/modified Blalock Taussig shunt (reintubation, 11%), and coarctation (reintubation, 5%). Figure 1 displays the frequency of the 6 major complications previously defined [7].

REPORT

Abbreviations and Acronyms

1839

REPORT Code

350 360 370 30

80 384 280 110 390 140 130 120 240 102 104 22 24 26 40 71 72 73 74 75 210 200 180 190 150

None Intraoperative death Readmission MSOF Cardiac arrest

Cardiac dysfunctionþC22 Cardiac failure Endocarditis Pericardial effusion Pulmonary hypertension Pulmonary hypertensive crisis Pulmonary vein obstruction Systemic vein obstruction Reoperation-bleeding Sternum open-planned Sternum open-unplanned Cardiac reoperation-not for bleeding Unplanned interventional catheterization Noncardiac reoperation Mechanical support Arrhythmia Arrhythmia-drug Arrhythmia-cardioversion/defibrillation Arrhythmia-permanent pacemaker Arrhythmia-temporary pacemaker Chylothorax Pleural effusion Pneumonia Pneumothorax Respiratory insufficiency-prolonged Respiratory insufficiency-reintubation Tracheostomy (Continued)


160 170

No complications during the intraoperative and postoperative time periods (no complications prior to discharge and no complications within 30 days of surgery) Intraoperative death or intraprocedural death Unplanned readmission to the hospital within 30 days of surgery or intervention Multi-system organ failure (MSOF) ¼ multi-organ dysfunction syndrome (MODS) Cardiac arrest, timing ¼ cardiac arrest (myocardial infarction) during or following procedure (perioperative/periprocedural ¼ intraoperative/intraprocedural and/or postoperative/ postprocedural) Cardiac dysfunction resulting in low cardiac output Cardiac failure (severe cardiac dysfunction) Endocarditis-postprocedural infective endocarditis Pericardial effusion, requiring drainage Pulmonary hypertension Pulmonary hypertensive crisis (pulmonary artery pressure > systemic pressure) Pulmonary vein obstruction Systemic vein obstruction Bleeding, requiring reoperation Sternum left open, planned Sternum left open, unplanned Unplanned cardiac reoperation during the postoperative or postprocedural time period, exclusive of reoperation for bleeding Unplanned interventional cardiovascular catheterization procedure during the postoperative or postprocedural time period Unplanned noncardiac reoperation during the postoperative or postprocedural time period Postoperative/postprocedural mechanical circulatory support (IABP, VAD, ECMO, or CPS) Arrhythmia Arrhythmia requiring drug therapy Arrhythmia requiring electrical cardioversion or defibrillation Arrhythmia necessitating pacemaker, permanent pacemaker Arrhythmia necessitating pacemaker, temporary pacemaker Chylothorax Pleural effusion, requiring drainage Pneumonia Pneumothorax, requiring intervention Postoperative/postprocedural respiratory insufficiency requiring mechanical ventilatory support > 7 days Postoperative/postprocedural respiratory insufficiency requiring reintubation Respiratory failure, requiring tracheostomy

Abbreviation


16

Complication

1840

Table 1. Complications


Table 1. Continued Code 230 223 224

Abbreviation

Renal failure - acute renal failure, acute renal failure requiring dialysis at the time of hospital discharge Renal failure - acute renal failure, acute renal failure requiring temporary dialysis with the need for dialysis not present at hospital discharge Renal failure - acute renal failure, acute renal failure requiring temporary hemofiltration with the need for dialysis not present at hospital discharge Sepsis Neurologic deficit, neurologic deficit persisting at discharge Neurologic deficit, transient neurologic deficit not present at discharge Paralyzed diaphragm (possible phrenic nerve injury) Peripheral nerve injury, neurologic deficit persisting at discharge Seizure Spinal cord injury, neurologic deficit persisting at discharge Stroke Vocal cord dysfunction (possible recurrent laryngeal nerve injury) Wound dehiscence (sterile) Wound dehiscence (sterile), median sternotomy Wound infection Wound infection-deep wound infection Wound infection-mediastinitis Wound infection-superficial wound infection Other complication Other operative/procedural complication

CPS ¼ cardiopulmonary support;

ECMO ¼ extracorporeal membrane oxygenation;

IABP ¼ intraaortic balloon pump;

Renal failure-dialysis at discharge Renal failure-temporary dialysis Renal failure-hemofiltration Sepsis Neurologic deficit-at discharge Neurologic deficit-transient Paralyzed diaphragm Peripheral nerve injury Seizure Spinal cord injury Stroke Vocal cord dysfunction Wound dehiscence Wound dehiscence-sternotomy Wound infection Wound infection-deep Mediastinitis Wound infection-superficial Other Other-operative

VAD ¼ ventricular assist device.


290 320 325 300 400 331 410 420 310 250 255 261 262 270 263 900 901

Complication

1841

REPORT

REPORT

1842

Benchmark Operations Isolated coarctation

ASD (only collected for operations with primary diagnosis ¼ 20 ¼ ASD, Secundum) VSD

TOF

AVC Modified Blalock-Taussig Shunt Superior cavopulmonary anastomosis(es)

Fontan

Arterial switch Arterial switch þ VSD Truncus Norwood

1210 ¼ Coarctation repair, end to end 1220 ¼ Coarctation repair, end to end, Extended 1230 ¼ Coarctation repair, subclavian flap 1240 ¼ Coarctation repair, patch aortoplasty 1250 ¼ Coarctation repair, interposition graft 20 ¼ ASD repair, primary closure 30 ¼ ASD repair, patch 100 ¼ VSD repair, primary closure 110 ¼ VSD repair, patch 120 ¼ VSD repair, device 350 ¼ TOF repair, no ventriculotomy 360 ¼ TOF repair, ventriculotomy, nontransanular patch 370 ¼ TOF repair, ventriculotomy, transanular patch 380 ¼ TOF repair, RV-PA conduit 170 ¼ AVC (AVSD) repair, complete (CAVSD) 1590 ¼ Shunt, systemic to pulmonary, Modified Blalock-Taussig Shunt (MBTS) 1670 ¼ Bidirectional cavopulmonary anastomosis (BDCPA) (bidirectional Glenn) 1690 ¼ Bilateral bidirectional cavopulmonary anastomosis (BBDCPA) (bilateral bidirectional Glenn) 1700 ¼ HemiFontan 2130 ¼ Superior cavopulmonary anastomosis(es) þ PA reconstruction 950 ¼ Fontan, atriopulmonary connection 960 ¼ Fontan, atrioventricular connection 970 ¼ Fontan, TCPC, lateral tunnel, fenestrated 980 ¼ Fontan, TCPC, lateral tunnel, nonfenestrated 1000 ¼ Fontan, TCPC, external conduit, fenestrated 1010 ¼ Fontan, TCPC, external conduit, nonfenestrated 1030 ¼ Fontan, other 1110 ¼ Arterial switch operation (ASO) 1120 ¼ Arterial switch operation (ASO) and VSD repair 230 ¼ Truncus arteriosus repair 870 ¼ Norwood procedure RV-PA ¼ right ventricle-pulmonary artery;

STS ¼ Society of Thoracic Surgeons;

TCPC ¼


ASD ¼ atrial septal defect; AVSD ¼ atrioventricular septal defect; CAVSD ¼ complete AVSD; total cavopulmonary connection; TOF ¼ tetralogy of Fallot; VSD ¼ ventricular septal defect.

STS Procedural Codes


Table 2. Inclusion Criteria



Table 5. Ventricular Septal Defect Closure (n ¼ 3,056)

Complications

Rate, n (%)

Complications

Rate, n (%)

Respiratory insufficiency-reintubation Chylothorax Respiratory insufficiency-prolonged Vocal cord dysfunction Readmission Non-cardiac reoperation Cardiac reoperation-not for bleeding Arrhythmia-drug Pleural effusion Wound dehiscence Sepsis Sternum open-planned Unplanned interventional catheterization Arrhythmia Pneumothorax Cardiac dysfunction Pulmonary hypertension Cardiac arrest Seizure Wound infection-superficial Paralyzed diaphragm Patients with no complications Patients with no major [7] complications

96 66 63 59 54 51 42 33 30 28 28 24 23 21 18 17 17 15 14 13 10 1185 1,740

Arrhythmia-temporary pacemaker Arrhythmia Arrhythmia-drug Respiratory insufficiency-reintubation Cardiac dysfunction Pleural effusion Readmission Respiratory insufficiency-prolonged Chylothorax Arrhythmia-permanent pacemaker Pneumothorax Cardiac reoperation-not for bleeding Noncardiac reoperation Pulmonary hypertension Pericardial effusion Pneumonia Sepsis Cardiac arrest Reoperation-bleeding Arrhythmia-cardioversion/defibrillation Patients with no complications Patients with no major [7] complications

178 125 98 70 60 60 60 50 40 38 34 32 28 30 22 22 22 20 20 17 2,026 2,941

(5.16) (3.55) (3.39) (3.17) (2.90) (2.74) (2.26) (1.77) (1.61) (1.50) (1.50) (1.29) (1.24) (1.13) (0.97) (0.91) (0.91) (0.81) (0.75) (0.70) (0.54) (63.68) (93.50)

Comment This inquiry was undertaken to provide congenital heart surgeons with empirically derived data, based on multiinstitutional experience, which together with data from personal and institutional experience may help to guide discussions of procedural complications during the informed consent process. The comprehensive list of complications, in its entirety, is cumbersome to review with patients or parents. We report complications (Tables 3 to 14) in each procedure category that had a rate of 0.5% or greater. As expected, patients undergoing neonatal surgery were more likely to experience sternum left open (ASO, ASO-VSD, truncus arteriosus, Norwood), while those patients who required extensive superior vena cava or transverse arch dissection (BiGlenn, Fontan, coarctation) were more likely to have pleural effusions or chylothorax. For the most part, the

Table 4. Atrial Septal Defect Closure (n ¼ 1,472) Complications

Rate, n (%)

Readmission Arrhythmia Pneumothorax Arrhythmia-temporary pacemaker Arrhythmia-drug Patients with no complications Patients with no major [7] complications

28 19 14 14 12 1,201 1,459

(1.90) (1.29) (0.95) (0.95) (0.82) (81.59) (99.12)

(5.82) (4.09) (3.21) (2.29) (1.96) (1.96) (1.96) (1.64) (1.31) (1.24) (1.11) (1.05) (0.92) (0.98) (0.72) (0.72) (0.72) (0.65) (0.65) (0.56) (66.30) (96.23)

rate of the 6 major complications [7] (Fig 1) demonstrates the increasing occurrence rates with increasing complexity across the procedure categories that were surveyed. The major complication, “Unplanned reoperation or cardiac catheterization reintervention” exhibited the highest rates (0% to 18%) among the procedure groups. Similar trends are noted for the other major complication categories, with the exception of “arrhythmia requiring permanent pacemaker,” which is more likely to occur in patients who had VSD closure as part of their repair. An awareness of the rate of occurrence and gravity of these complications can help guide the surgeon’s interaction with the parents or patients. Some authors [5, 6] have performed survey studies and have concluded that minor and major complications that occur in over 5% and 0.1% of patients, respectively, are worthy of discussion. The comprehensive list is a supportive document for structured questions that demand more knowledge. Practical wisdom can guide the surgeon in certain specific conditions. For instance, one would discuss risk of paraplegia when discussing coarctation repair, but not in the context of most open heart procedures that do not involve arch reconstruction. The same can be said of other enduring complications such as heart block, nerve injury, and renal failure. Importantly, this discussion can also explore the concept of relative risk and long-term outcome, which places into opposition the untreated natural history of the disease process with the risks of the proposed reparative operation. Such a dialogue can form the rational basis for proceeding with what may be

REPORT

Table 3. Coarctation Repair (n ¼ 1,861)

1843

1844



Table 6. Tetralogy of Fallot Repair (n ¼ 1,862)

Table 7. Atrioventricular Canal Repair (n ¼ 1,172)

Complications

Rate, n (%)

Complications

Rate, n (%)

Arrhythmia-temporary pacemaker Arrhythmia-drug Pleural effusion Arrhythmia Respiratory insufficiency-reintubation Respiratory insufficiency-prolonged Chylothorax Cardiac dysfunction Cardiac reoperation-not for bleeding Sternum open-planned Noncardiac reoperation Readmission Sternum open-unplanned Sepsis Mechanical support Paralyzed diaphragm Cardiac arrest Pneumothorax Pneumonia Seizure Reoperation-bleeding Arrhythmia-permanent pacemaker Pericardial effusion Pulmonary hypertension Unplanned interventional catheterization Wound infection-superficial Cardiac failure Vocal cord dysfunction Neurologic deficit-at discharge Arrhythmia-cardioversion/defibrillation Wound infection Patients with no complications Patients with no major [7] complications

166 162 122 101 82 81 81 70 44 44 43 43 38 32 27 26 25 25 22 22 21 20 17 17 16 16 13 12 11 11 10 1,005 1,710

Arrhythmia-temporary pacemaker Respiratory insufficiency-reintubation Chylothorax Respiratory insufficiency-prolonged Arrhythmia Pulmonary hypertension Pleural effusion Arrhythmia-drug Cardiac dysfunction Cardiac reoperation-not for bleeding Readmission Sepsis Sternum open-unplanned Pneumonia Cardiac arrest Arrhythmia-permanent pacemaker Noncardiac reoperation Sternum open-planned Mechanical support Pneumothorax Pericardial effusion Seizure Tracheostomy Reoperation-bleeding Wound infection-superficial Vocal cord dysfunction Cardiac failure Neurologic deficit-at discharge Multi-system organ failure Unplanned interventional catheterization Pulmonary hypertensive crisis Wound infection Patients with no complications Patients with no major [7] complications

172 95 94 89 80 78 74 63 53 51 50 39 34 33 31 28 26 22 21 18 15 14 12 11 11 10 10 9 9 9 8 7 550 1,053

(8.92) (8.70) (6.55) (5.42) (4.40) (4.35) (4.35) (3.76) (2.36) (2.36) (2.31) (2.31) (2.04) (1.72) (1.45) (1.40) (1.34) (1.34) (1.18) (1.18) (1.13) (1.07) (0.91) (0.91) (0.86) (0.86) (0.70) (0.64) (0.59) (0.59) (0.54) (53.97) (91.84)

REPORT

termed a “high risk” operation, when all options are considered. In a broader sense, the idea of learning how to perform informed consent has historical significance and dates back to antiquity [10]. The essential question was whether moral virtue can be taught. This issue would be taken up again by Aristotle, who described moral virtue as, “The habit of choosing the golden mean, between extremes, as it pertains to an emotion or an action” [11]. Informed consent therefore condenses into a virtuous way of presenting empirical data to the patient. This tension between scientific evidence and moral authority has been heretofore delegated to the “art of medicine,” a concept grounded in paternalism and practical wisdom. Some authors, based on physician surveys, have suggested certain thresholds to guide the informed consent process. The question arises, is it possible to look at a complication list and categorically state that anything over 5% occurrence rate is worth discussing and anything below is not? Obviously, this is not possible, at least not in the purist rational sense. What

(14.68) (8.11) (8.02) (7.59) (6.83) (6.66) (6.31) (5.38) (4.52) (4.35) (4.27) (3.33) (2.90) (2.82) (2.65) (2.39) (2.22) (1.88) (1.79) (1.54) (1.28) (1.19) (1.02) (0.94) (0.94) (0.85) (0.85) (0.77) (0.77) (0.77) (0.68) (0.60) (46.93) (89.85)

is possible is to invoke the “habit of choosing” [11], namely that we acquire a set of principles over a lifetime of study and learn from others who we feel match up with virtuous habits. We physicians then engage our acquired practical wisdom and knowledge of empirical data to do the right thing; namely to engage in a rational, sympathetic, and informative dialogue with our patients and venture to find the right balance of informed consent based on mutual trust, beneficence, and finding the “Golden Mean,” which may be something today and something else tomorrow based on the circumstances. The common threads are being aware of the empirical data and achieving moral virtue. We should engage in the informed consent process more so for moral reasons based on Aristotelian [11] and Kantian [12] ethical tenets than for legal reasons established by the courts [4]. In a substantial way, being informed of potential complications solidifies the doctorpatient relationship by open discussion that recognizes


1845

Table 8. Modified Blalock-Taussig Shunt (n ¼ 857)

Table 9. Bidirectional Glenn (n ¼ 1,694)

Complications

Rate, n (%)

Complications

Rate, n (%)

Respiratory insufficiency-reintubation Cardiac reoperation-not for bleeding Respiratory insufficiency-prolonged Cardiac dysfunction Cardiac arrest Noncardiac reoperation Sternum open-planned Readmission Arrhythmia-drug Pleural effusion Mechanical support Arrhythmia Wound infection-superficial Chylothorax Sepsis Unplanned interventional catheterization Sternum open-unplanned Cardiac failure Arrhythmia-temporary pacemaker Pulmonary hypertension Pericardial effusion Reoperation-bleeding Paralyzed diaphragm Vocal cord dysfunction Renal failure-temporary dialysis Pneumothorax Seizure Wound dehiscence Wound dehiscence-sternotomy Multi-system organ failure Tracheostomy Mediastinitis Pneumonia Systemic vein obstruction Neurologic deficit-at discharge Wound infection Patients with no complications Patients with no major [7] complications

91 89 86 75 71 53 44 42 40 29 26 26 26 25 24 21 19 18 17 16 13 13 12 12 12 10 10 9 9 9 8 8 7 5 5 5 320 681

Chylothorax Respiratory insufficiency-reintubation Pleural effusion Unplanned interventional catheterization Readmission Respiratory insufficiency-prolonged Noncardiac reoperation Paralyzed diaphragm Cardiac dysfunction Pulmonary hypertension Cardiac reoperation-not for bleeding Arrhythmia-temporary pacemaker Arrhythmia Pneumothorax Arrhythmia-drug Sepsis Reoperation-bleeding Mediastinitis Pneumonia Mechanical support Cardiac arrest Sternum open-planned Cardiac failure Seizure Wound infection-superficial Sternum open-unplanned Wound infection Pericardial effusion Systemic vein obstruction Arrhythmia-permanent pacemaker Stroke Patients with no complications Patients with no major [7] complications

120 89 87 70 65 63 54 53 51 51 48 46 43 36 33 27 23 22 20 18 16 16 14 14 14 11 11 10 10 9 9 933 1,483

(10.62) (10.39) (10.04) (8.75) (8.28) (6.18) (5.13) (4.90) (4.67) (3.38) (3.03) (3.03) (3.03) (2.92) (2.80) (2.45) (2.22) (2.10) (1.98) (1.87) (1.52) (1.52) (1.40) (1.40) (1.40) (1.17) (1.17) (1.05) (1.05) (1.05) (0.93) (0.93) (0.82) (0.58) (0.58) (0.58) (37.34) (79.46)

the reality of human behavior, error, and disclosure. The process is meant to convey confidence, hope, and acceptance throughout the hospitalization and beyond. The limitations of this study include all issues relating to a large registry database without long-term follow-up. In addition, reporting of frequencies of specific complications was constrained by the terms and definitions used in the STS-CHSDB. Consideration was given to grouping individual complications into categories (eg, arrhythmias). Because of the possibility of instances of dual entry and the uncertainty whether these represent unique events, we decided not to condense the data in this fashion. We therefore report the data as they are and

(7.08) (5.25) (5.14) (4.13) (3.84) (3.72) (3.19) (3.13) (3.01) (3.01) (2.83) (2.72) (2.54) (2.13) (1.95) (1.59) (1.36) (1.30) (1.18) (1.06) (0.94) (0.94) (0.83) (0.83) (0.83) (0.65) (0.65) (0.59) (0.59) (0.53) (0.53) (55.08) (87.54)

leave to the reader to choose the golden mean as to what to tell the family in the informed consent process. The informed consent process for congenital heart surgery may be enhanced by availability of accurate contemporary data on occurrence of complications associated with a given procedure. While complication rate thresholds may guide the clinician, rare but important debilitating complications, such as paraplegia after coarctation repair, should also be discussed irrespective of frequency. Our analysis should better inform the process of informed consent by providing the clinician with objective data about complications for each type of procedure.

REPORT


1846



Table 10. Fontan (n ¼ 1,696)

Table 11. Arterial Switch (n ¼ 727)

Complications

Rate, n (%)

Complications

Rate, n (%)

Pleural effusion Arrhythmia-temporary pacemaker Chylothorax Readmission Cardiac dysfunction Arrhythmia Arrhythmia-drug Cardiac reoperation-not for bleeding Reoperation-bleeding Unplanned interventional catheterization Respiratory insufficiency-reintubation Noncardiac reoperation Respiratory insufficiency-prolonged Arrhythmia-permanent pacemaker Pneumothorax Pericardial effusion Neurologic deficit-at discharge Sepsis Cardiac arrest Mechanical support Paralyzed diaphragm Seizure Stroke Pulmonary hypertension Sternum open-unplanned Wound infection-superficial Mediastinitis Cardiac failure Multi-system organ failure Wound infection Arrhythmia-cardioversion/defibrillation Renal failure-temporary dialysis Systemic vein obstruction Pneumonia Wound infection-deep Patients with no complications Patients with no major [7] complications

272 171 159 102 81 78 58 57 45 44 39 38 37 31 30 26 24 23 21 20 19 19 18 17 15 13 12 12 11 11 10 10 9 9 9 745 1,485

Sternum open-planned Arrhythmia-drug Cardiac dysfunction Respiratory insufficiency-prolonged Arrhythmia Arrhythmia-temporary pacemaker Chylothorax Sternum open-unplanned Reoperation-bleeding Pleural effusion Respiratory insufficiency-reintubation Mechanical support Paralyzed diaphragm Cardiac reoperation-not for bleeding Wound infection-superficial Noncardiac reoperation Pulmonary hypertension Sepsis Readmission Cardiac failure Unplanned interventional catheterization Pneumothorax Wound dehiscence Wound infection Cardiac arrest Seizure Systemic vein obstruction Vocal cord dysfunction Pericardial effusion Neurologic deficit-at discharge Arrhythmia-cardioversion/defibrillation Multi-system organ failure Wound dehiscence-sternotomy Mediastinitis Neurologic deficit-transient Pneumonia Renal failure-hemofiltration Stroke Patients with no complications Patients with no major [7] complications

189 103 67 65 59 52 51 50 42 41 33 29 28 27 23 21 19 17 17 17 16 14 14 14 13 13 12 12 9 9 9 7 6 5 5 4 4 4 234 607

(16.04) (10.08) (9.38) (6.01) (4.78) (4.60) (3.42) (3.36) (2.65) (2.59) (2.30) (2.24) (2.18) (1.83) (1.77) (1.53) (1.42) (1.36) (1.24) (1.18) (1.12) (1.12) (1.06) (1.00) (0.88) (0.77) (0.71) (0.71) (0.65) (0.65) (0.59) (0.59) (0.53) (0.53) (0.53) (43.93) (87.56)

(26.00) (14.17) (9.22) (8.94) (8.12) (7.15) (7.02) (6.88) (5.78) (5.64) (4.54) (3.99) (3.85) (3.71) (3.16) (2.89) (2.61) (2.34) (2.34) (2.34) (2.20) (1.93) (1.93) (1.93) (1.79) (1.79) (1.65) (1.65) (1.24) (1.24) (1.24) (0.96) (0.83) (0.69) (0.69) (0.55) (0.55) (0.55) (32.19) (83.49)

REPORT



Complications

Rate, n (%)

Sternum open-planned Arrhythmia-temporary pacemaker Respiratory insufficiency-prolonged Arrhythmia-drug Arrhythmia Sternum open-unplanned Chylothorax Cardiac dysfunction Mechanical support Pleural effusion Cardiac reoperation-not for bleeding Cardiac arrest Respiratory insufficiency-reintubation Reoperation-bleeding Cardiac failure Noncardiac reoperation Pneumothorax Pulmonary hypertension Arrhythmia-permanent pacemaker Vocal cord dysfunction Renal failure-temporary dialysis Wound dehiscence Sepsis Unplanned interventional catheterization Arrhythmia-cardioversion/defibrillation Wound infection-superficial Pericardial effusion Systemic vein obstruction Mediastinitis Paralyzed diaphragm Neurologic deficit-at discharge Readmission Renal failure-hemofiltration Wound infection-deep Pneumonia Multi-system organ failure Seizure Renal failure-dialysis at discharge Wound infection Patients with no complications Patients with no major [7] complications

102 50 44 43 40 36 29 28 27 26 24 22 22 18 16 16 12 11 10 9 9 7 7 7 7 7 6 6 5 5 4 4 4 4 3 3 3 2 2 82 267

(29.48) (14.45) (12.72) (12.43) (11.56) (10.40) (8.38) (8.09) (7.80) (7.51) (6.94) (6.36) (6.36) (5.20) (4.62) (4.62) (3.47) (3.18) (2.89) (2.60) (2.60) (2.02) (2.02) (2.02) (2.02) (2.02) (1.73) (1.73) (1.45) (1.45) (1.16) (1.16) (1.16) (1.16) (0.87) (0.87) (0.87) (0.58) (0.58) (23.70) (77.17)

Table 13. Truncus (n ¼ 224) Complications

Rate, n (%)

Sternum open-planned Respiratory insufficiency-prolonged Cardiac dysfunction Sternum open-unplanned Arrhythmia-drug Respiratory insufficiency-reintubation Cardiac reoperation-not for bleeding Noncardiac reoperation Cardiac arrest Arrhythmia-temporary pacemaker Reoperation-bleeding Pulmonary hypertension Arrhythmia Mechanical support Unplanned interventional catheterization Paralyzed diaphragm Pleural effusion Chylothorax Vocal cord dysfunction Cardiac failure Tracheostomy Seizure Readmission Pneumonia Pneumothorax Wound dehiscence-sternotomy Wound infection-superficial Pericardial effusion Systemic vein obstruction Sepsis Multi-system organ failure Arrhythmia-cardioversion/defibrillation Wound dehiscence Mediastinitis Neurologic deficit-at discharge Renal failure-temporary dialysis Patients with no complications Patients with no major [7] complications

92 40 27 24 22 21 19 19 18 18 17 16 16 13 13 12 11 11 9 7 6 6 5 4 4 4 4 3 3 3 3 3 2 2 2 2 42 159

(41.07) (17.86) (12.05) (10.71) (9.82) (9.38) (8.48) (8.48) (8.04) (8.04) (7.59) (7.14) (7.14) (5.80) (5.80) (5.36) (4.91) (4.91) (4.02) (3.13) (2.68) (2.68) (2.23) (1.79) (1.79) (1.79) (1.79) (1.34) (1.34) (1.34) (1.34) (1.34) (0.89) (0.89) (0.89) (0.89) (18.75) (70.98)

REPORT

Table 12. Arterial Switch and Ventricular Septal Defect (n ¼ 346)

1847

1848



Table 14. Norwood (n ¼ 1,151)

Table 14. Continued

Complications

Rate, n (%)

Complications

Rate, n (%)

Sternum open-planned Respiratory insufficiency-prolonged Respiratory insufficiency-reintubation Mechanical support Arrhythmia-drug Cardiac dysfunction Cardiac arrest Cardiac reoperation-not for bleeding Vocal cord dysfunction Non-cardiac reoperation Chylothorax Reoperation-bleeding Cardiac failure Arrhythmia-temporary pacemaker Pleural effusion Sepsis Sternum open-unplanned Unplanned interventional catheterization Arrhythmia Seizure Readmission Pneumothorax Renal failure-temporary dialysis Paralyzed diaphragm

724 313 178 175 162 160 138 136 118 114 98 94 87 87 81 81 77 70 67 57 50 46 40 35

Pulmonary hypertension Stroke Multi-system organ failure Wound infection-superficial Neurologic deficit-at discharge Systemic vein obstruction Tracheostomy Wound dehiscence Arrhythmia-cardioversion/defibrillation Wound dehiscence-sternotomy Renal failure-hemofiltration Renal failure-dialysis at discharge Wound infection Pericardial effusion Pneumonia Arrhythmia-permanent pacemaker Mediastinitis Intraoperative death Wound infection-deep Postoperative endocarditis Neurologic deficit-transient Patients with no complications Patients with no major [7] complications

34 28 26 25 24 23 21 19 19 17 17 16 16 13 12 12 11 8 8 7 6 117 713

(62.90) (27.19) (15.46) (15.20) (14.07) (13.90) (11.99) (11.82) (10.25) (9.90) (8.51) (8.17) (7.56) (7.56) (7.04) (7.04) (6.69) (6.08) (5.82) (4.95) (4.34) (4.00) (3.48) (3.04)

(2.95) (2.43) (2.26) (2.17) (2.09) (2.00) (1.82) (1.65) (1.65) (1.48) (1.48) (1.39) (1.39) (1.13) (1.04) (1.04) (0.96) (0.70) (0.70) (0.61) (0.52) (10.17) (61.95)

(Continued)

REPORT Fig 1. Graphs display the frequency of 6 major complications categories [7]. The Society of Thoracic Surgeons Congenital Heart Surgery Database Version 3.0 complication codes for these 6 major complications are as follows: (A) Renal failure requiring temporary/permanent dialysis: 223, 224, 230; (B) Postoperative neurologic deficit persisting at discharge: 320; (C) Arrhythmia requiring permanent pacemaker: 74; (D) Postoperative mechanical circulatory support: 40; (E) Phrenic nerve injury/paralyzed diaphragm: 300; (F) Unplanned cardiac reoperation or catheterization intervention: 22, 24, 26, 240. (ASD ¼ atrial septal defect; ASO ¼ arterial switch operation; AVC ¼ atrioventricular canal; MBTS ¼ modified Blalock Taussig shunt; TOF ¼ tetralogy of Fallot; VSD ¼ ventricular septal defect.)


References 1. Mavroudis C, Mavroudis CD, Farrell RM, Jacobs ML, Jacobs JP, Kodish E. Informed consent, bioethical equipoise, and hypoplastic left heart syndrome. Cardiol Young 2011;21(Suppl 2):133–40. 2. Berg JW, Appelbaum PS, Lidz CW, Parker LS. Informed Consent: Legal Theory and Clinical Practice. 2nd ed. New York, NY: Oxford University Press; 2001. 3. Manson NC, O’Neill O. Rethinking Informed Consent in Bioethics. 1st ed. New York, NY: Cambridge University Press; 2007. 4. Salgo v. Leland Stanford Jr University Board of Trustees (154 Cal. App. 3d 560, 317 P.2d 170 [1957]). 5. Pleat JM, Dunkin CSJ, Davies CE, Ripley RM, Tyler MPH. Prospective survey of factors affecting risk discussion during consent in a surgical specialty. Br J Surg 2004;91:1377–80. 6. McLaren A, Morris-Stiff G, Casey J. Issues of consent in renal transplantation. Ann R Coll Surg Engl 2001;83:343–6.


1849

7. Jacobs ML, O’Brien SM, Jacobs JP, et al. An empirically based tool for analyzing morbidity associated with operations for congenital heart disease. J Thorac Cardiovasc Surg 2013;145: 1046–57. 8. Brenner LH, Brenner AT, Horowitz D. Beyond informed consent: educating the patient. Clin Orthop Relat Res 2009;467:348–51. 9. O’Brien SN, Clarke DR, Jacobs JP, et al. An empirically based mortality index for analyzing outcomes of congenital heart surgery. J Thorac Cardiovasc Surg 2009;138:1139–53. 10. Denyer N, ed. Plato. Protagoras. New York, NY: Cambridge University Press; 2008. 11. Aristotle. The Nicomachean Ethics, Book III (translated by Sir David Ross). London, UK: Oxford University Press; 1954. 12. Kant I. Grounding for the Metaphysics of Morals [1785] (translated by James Wesley Ellington). Indianapolis, IN: Hackett Pub Co.; 1981.

DISCUSSION

DR JEFFREY P. JACOBS: Thank you, Tara. I’d like to also thank you for engaging in a dialogue with Gus and I and Marshal about these questions, and I am going to be able to share some answers that come from our group. Regarding your first question, I think this is a very important practical issue which brings into question both the veracity of the data in the database and also the concept of truth-telling. The goals of the informed consent process are, first, to establish a personal relationship with the family and the patient; second, to instill confidence with the family and the patient in the team providing the care; and third, certainly to explain the nature of the procedure, the risks, and alternatives of the procedure being performed. All questions need to be answered truthfully and without agendas. The moral tenets are to do good for the patient’s own sake and not for the sake of any other party. Describing disparate outcomes from local or distant programs is a matter of judgment as long as the local outcomes of the home institution are judged to be clinically acceptable by the referring physician, national standards, and the clinical team. If the results of a local program are suboptimal and discordant with the national standards, an internal review and improvement process should predate any further operation.

In keeping with these tenets, these issues need to be openly disclosed with the family, and probably if a program has results that are clearly suboptimal and disparate in comparison to national aggregate standards, that program should hold off on doing those operations until quality improvement initiatives are operationalized. DR KARAMLOU: My second question. What do the authors feel can be optimized regarding the environment of informed consent? In other words, many times I don’t see my preoperative patients until the day before surgery, which I always find to be less than ideal in terms of preparing the family for surgery and answering all of their questions. Do the authors have any insight or data regarding the optimal timing of the consent process? DR JEFFREY P. JACOBS: First of all, the advent of fetal echocardiography and prenatal surgical informed consent has favorably impacted on the surgeon-patient relationship and certainly relates to this question. The family can meet with the surgeon before the baby is born and then will feel a sense of familiarity and confidence in the program. The postnatal informed consent process then is viewed as a continuation of the relationship that has already been forged. But in a practical sense, it is not always possible to see patients and their families days or weeks before an operation due to distant referral, emergency conditions, and familial considerations. While comprehensive informed consent based on what might be considered an optimal process may not be feasible, it is feasible to establish a meaningful relationship that can be enhanced by frequent nurse practitioner visits and updates during the operation. Of course, these recommendations are anecdotal and, to our knowledge, have not been studied or published. In general, preoperative consultation and obtaining informed consent is a process that should occur well before the operation and then allows for more thoughtful processes that can result into further inquiry and discussion, reinforced by other members of the health care team. DR KARAMLOU: Finally, several articles in the literature have raised the issue of patient retention. Although the surgeon may quote an accurate and comprehensive risk profile, often patients, if queried, will have poor retention of this information. Other than streamlining the quoted risks, ie, the example you gave of paraplegia in coarctation, how do the authors propose one can improve patient-family understanding and retention?

REPORT

DR TARA KARAMLOU (San Francisco, CA): Dr Jacobs, now sitting in for Dr Mavroudis, and his colleagues have presented an excellent study in which they have cataloged the contemporary risks of 12 index operations using the 2010 to 2011 STS [Society of Thoracic Surgeons] congenital heart surgery database. The authors have provided us with informative statistics regarding the most frequent complications of these procedures, and in doing so, have given us additional tools to improve and inform the consent process. The authors have found important patterns, many of which are expected. For example, neonatal repairs had a high incidence of unplanned delayed sternal closure, bidirectional Glenn, and Fontan patients suffered higher rates of chylothorax, and ASDs [atrial septal defects] had a moderate risk of readmission, presumably for pericarditis-associated complications. I congratulate the authors and Dr Jacobs on a very well written manuscript and an important descriptive analysis. I have several questions. First, although it is truly important to have contemporary data from a national sample, I wonder how the authors integrate their own institutional or even individual surgeon outcome data into the informed consent process? For instance, how would they recommend dealing with discordant results, either favorable or otherwise?

1850


I thank you very much for allowing me to discuss this excellent paper and thank the Association for inviting me as a discussant. DR JEFFREY P. JACOBS: Well, thanks, Tara. This last question is a difficult question, which, as you have pointed out, has been a source of multiple investigations that demonstrate the drawbacks of a system that leads to misunderstanding more often than not. The intent of the informed consent process is to be enlightening, not confusing. There have been some studies that have looked at the importance of a multidisciplinary approach to informed consent, allowing the patient and family to interact with multiple members of the health care team. This approach offers more interaction and increases the chance of data retention. Other studies have noted that the age and level of education play a major role in retention. The range of socioeconomic, educational, and cultural intervening issues to determine retention are complex and not amenable to any individual formula. In the end, informed consent relies on the skill, sensitivity, and concern of the clinician, who must understand that the informed consent process is for the benefit of the patient and the family. Sympathetic, genuine, and personal interaction should, for the most part, reveal familial misunderstanding and questions of retention. Teaching tools such as drawings and models of the heart can help, and the role of the physician in these circumstances is to reengage with the family and optimize the interaction, often helped by nurses, nurse practitioners, and the remainder of the health care team.

REPORT

DR CARL L. BACKER (Chicago, IL): I sincerely congratulate you and Dr Mavroudis on this effort. I think this has the opportunity to be a monumental paper resulting in a paradigm shift in the way we obtain surgical consent for congenital heart procedures. Looking at those complications all listed out, especially for the Norwood operation, is an eye-opening display of how complex these cases are. It is hard to verbally convey that degree of potential for substantial complications. I think it would be a great improvement in transparency to have these lists of complications and percentages available to our patients and their families for each one of the major diagnoses. Another advantage is that in many cases advance practice nurses are the ones that talk to the families in detail about potential complications. They have the time to do this during the day while we are in the operating room. Then the surgeon meets with the family for a short period of time, sometimes as Tara noted, not until the morning of the operation. These lists would give the family enhanced informed consent. The question I have for you and this gets to Tara’s final question, is about the institutional outcomes. For example, for the patient having VSD [ventricular septal defect] closure; there are both national statistics on incidence of heart block and institutional statistics from the STS. It would not just be a surgeon telling the patient that they have a low incidence of heart block, but rather the surgeon giving the family his or her last five years of institutional data on this potential complication from the STS. Do you think that would ever be something that could be conveyed to the families? That would be full disclosure both of potential complications on a national basis and the local institutional experience. Again, I congratulate you on a landmark contribution. DR JEFFREY P. JACOBS: Carl, that’s a great question and it’s very timely. It’s very timely with recent events in the lay press; it’s very timely with the increased effort and desire of the STS to publicly report cardiac surgical outcomes. As our patients and their families get more educated, there’s going to be more and


more of a desire for them to have transparent access not only to national aggregate outcomes but to our own individual outcomes. And I think we as a group of surgeons need to be prepared for an increasing need for that data to be distributed in a transparent fashion. The best thing we can do to help ourselves is to make sure we continue to support our database that presents these data in a fair, equitable fashion using clinical data so the data that we are sharing is meaningful. The challenge of sharing these data with patients and parents is real, and we have to present them with real honest data but also find a way to be optimistic and say that, yes, this is all the massive list of horrible things that might happen after this operation, but most of the time things are going to be okay. And I think that’s realistic for most of the things we do, and we have to present that in an optimistic but realistic way, I believe. DR JOHN MAYER (Boston, MA): I am going to wax philosophical here just for a minute based on almost 30 years of doing congenital heart surgery. The approach that I have taken, and which I have tried to teach the trainees that come through Boston Children’s Hospital. Despite the fact that we always want to be optimistic and we always want to paint a hopeful picture for the patients, I would argue that what we do is odds. I would argue that all of the practice of medicine in all ranges of complexity, from simple to most complex still reduces to the concept that we do odds. During every preoperative patient meeting, I couch my entire discussion about what are the odds for a given operation versus what are the odds for the natural history versus what are the odds for any alternative form of treatment. Our job is to pick the course of action that gives the individual patient the best odds and the least risk. To that point, I think it’s worth mentioning that the one in several hundred risk of paraplegia in coarctation is a reasonable thing to say, but it’s balanced against the risk of long-term untreated coarctation with a risk for cerebral bleeds or MIs [myocardial infarctions] or any of the other complications of the natural history of coarctation. I would argue, and it has been my observation, that almost every family, regardless of socioeconomic status, level of intellectual functioning, or medical sophistication understands the idea of odds. Everybody has played poker, everybody has rolled the dice. Even the least sophisticated people still understand the concept of odds and that our physician role is to recommend a course of treatment that provides the best odds and the least risk. I think that that’s a good way to approach this question of potential complications of a procedure. That’s the approach that I have adopted over a number of years, and I think it’s worth sharing with all of you. The only other part of this, because this issue of informed consent always puts us physicians a little bit on the defensive, is that I think there’s actually a benefit for the families. The benefit for the families is that it takes this incredibly emotional event of handing your baby over to some stranger that you have just met in the last 24 or 48 hours, and this discussion of trying to find the treatment with the best odds takes it out of that very emotional realm and it brings it down to something that’s more in rational realm. They, even if you have a bad outcome, have the sense and the personal peace if you will that they followed a recommended course of treatment that offered their child the best odds. At some level then everyone can recognize and understand that not every outcome is going to be perfect. I offer this as an approach and as a mindset going into these discussions, and I think, hopefully, it’s worth everyone considering as they are thinking about how to approach families. From our perspective, I think it has worked pretty well.

DR JEFFREY P. JACOBS: Thanks, John. DR GEORGE DAICOFF (Saint Petersburg, FL): Jeff, I think you did a fantastic job of showing a lot of data, a lot of work involved in that, and we are appreciative, and it should be a thing that’s available for all of us. I was a little bit disappointed to see that you didn’t include death. I always discuss death when I talk to parents or patients, and that should be part of the discussion. The other thing is I think it’s baloney that we should have an attorney tell us what is informed consent. I think we need to have a position paper of what we consider informed consent for the reasons raised: one, it scares the heck out of these people, and, secondly, there are issues like paraplegia that should be discussed even if it is not discussed because of a low incidence of occurrence. Based on your vast knowledge and experience in this area, I think you should prepare a position paper regarding what we regard as appropriate surgical informed consent. The paper should be published with the authority and blessing of every major surgical association with which we are involved and say this is what we think informed consent is, period.


1851

DR JEFFREY P. JACOBS: Thank you, George. I would say, first of all, the opportunity to present this paper and these data is a pretty big deal for me. I’m presenting it in the place of one of my mentors, Gus Mavroudis, and now I’m discussing it and fielding questions and comments from a past STS president in John Mayer and from the guy that hired me when I was in training, George Daicoff. So it’s a fairly meaningful moment. Now, to address your questions. Your question about death is important, and the focus of this analysis was to look at complications, basically because our group has previously published an analysis of the same set of benchmark operations where we looked precisely at death and postoperative length of stay. So we have already published this analysis looking at death and postoperative length of stay. And I agree with you completely that any discussion with a family about complications and risks needs to start out with a chance of dying, because every one of these operations have a chance of dying, and that has to be the first risk that’s explained. So you are absolutely right and I agree with you. Regarding your concept about the structure of informed consent being directed by physicians and health care providers rather than by lawyers, I agree completely and I say yes, sir.

REPORT


Reoperations for pediatric and congenital heart disease: an analysis of the Society of Thoracic Surgeons (STS) congenital heart surgery database.

Contemporary outcomes of complete atrioventricular septal defect repair: analysis of the Society of Thoracic Surgeons Congenital Heart Surgery Database.

The importance of patient-specific preoperative factors: an analysis of the society of thoracic surgeons congenital heart surgery database.

Perioperative mechanical circulatory support in children: an analysis of the Society of Thoracic Surgeons Congenital Heart Surgery Database.

Reasons to participate in European Society of Thoracic Surgeons database.

Stage 1 hybrid palliation for hypoplastic left heart syndrome--assessment of contemporary patterns of use: an analysis of The Society of Thoracic Surgeons Congenital Heart Surgery Database.

Adverse cardiac events in children with Williams syndrome undergoing cardiovascular surgery: An analysis of the Society of Thoracic Surgeons Congenital Heart Surgery Database.

Gestational age at birth and outcomes after neonatal cardiac surgery: an analysis of the Society of Thoracic Surgeons Congenital Heart Surgery Database.

Concomitant tricuspid valve surgery during implantation of continuous-flow left ventricular assist devices: a Society of Thoracic Surgeons database analysis.

Aortic root surgery in the United States: a report from the Society of Thoracic Surgeons database.

Prevalence of Noncardiac and Genetic Abnormalities in Neonates Undergoing Cardiac Operations: Analysis of The Society of Thoracic Surgeons Congenital Heart Surgery Database.

International participation in the Society of Thoracic Surgeons National Database.

Burden of air leak complications in thoracic surgery estimated using a national hospital billing database.

Video-assisted thoracic surgery complications.

Sex differences in early outcomes after lung cancer resection: analysis of the Society of Thoracic Surgeons General Thoracic Database.

Complications of bronchial stapling in thoracic surgery.

The European general thoracic surgery database project.

[Complications in thoracic surgery : reports from experienced thoracic surgeons].

Comparing robotic lung resection with thoracotomy and video-assisted thoracoscopic surgery cases entered into the Society of Thoracic Surgeons database.

Linking the congenital heart surgery databases of the Society of Thoracic Surgeons and the Congenital Heart Surgeons' Society: part 1--rationale and methodology.

Video-assisted thoracoscopic surgery versus open lobectomy for primary non-small-cell lung cancer: a propensity-matched analysis of outcome from the European Society of Thoracic Surgeon database.

Predictors of Major Morbidity or Mortality After Resection for Esophageal Cancer: A Society of Thoracic Surgeons General Thoracic Surgery Database Risk Adjustment Model.

Outcomes and prosthesis choice for active aortic valve infective endocarditis: analysis of the Society of Thoracic Surgeons Adult Cardiac Surgery Database.

Journal of Thoracic Disease is endorsed by the Brazilian Society of Thoracic Surgery (SBCT).