M.R. de Leval

Evaluation and stages of surgical innovations

Surgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against the potential harms of any novel procedure. In this first of three Series papers on surgical innovation and evaluation, we propose a five-stage paradigm to describe the development of innovative surgical procedures.

Use of computational fluid dynamics in the design of surgical procedures: Application to the study of competitive flows in cavopulmonary connections

Computational fluid dynamic methods based on a finite-element technique were applied to the study of (1) competition of flows in the inferior and superior venae cavae in total cavopulmonary connection, and (2) competition between flow in the superior vena cava and forward flow from a stenosed pulmonary artery in bidirectional cavopulmonary anastomosis. Models corresponding to various degrees of offsetting and shape of the inferior vena caval anastomosis were simulated to evaluate energy dissipation and flow distribution between the two lungs. A minimal energy loss with optimal flow distribution between the two lungs was obtained by enlarging the inferior vena caval anastomosis toward the right pulmonary artery. This modified technique of total cavopulmonary connection is described. A computational model of the operation was developed in an attempt to understand the mechanisms of postoperative failure. In tight pulmonary artery stenosis (75%), the pulsatile forward flow is primarily directed to the left pulmonary artery, with little influence on superior vena caval pressure and the right pulmonary artery. Pulsatile forward flows corresponding to 15%, 30%, 45%, and 60% of the systemic artery output increased the mean pulmonary artery and superior vena caval pressures by 1, 1.7, 2.4, and 3.6 mm Hg, respectively. Although the modeling studies were not able to determine the cause of postoperative failure, they emphasize the impact of local geometry on flow dynamics. More simulations are required for further investigation of the problem.

Fate Of Subpulmonary Homograft Conduits: Determinants Of Latehomograft Failure

PATIENTS AND METHODS Between 1971 and 1993, 656 conduits were placed in the subpulmonary position. Patients receiving heterografts or valveless conduits and patients dying within 90 days of insertion were excluded; thus 405 homograft conduits were studied. There were 293 aortic homografts, 94 pulmonary, and 18 of unknown type. The end point of conduit failure was defined by conduit replacement for whatever reason, balloon dilation of the conduit, or death of the patient with the conduit in place. The following factors were analyzed: aortic versus pulmonary homograft, antibiotic preservation versus cryopreservation, ABO and Rh compatibility, type of material used for conduit extension, age at operation, size of the conduit, diagnosis, and reoperations. Conduit number (1 to 405) in the series was included in the multivariable model. RESULTS First conduits and conduits inserted earlier in the series appeared to last longer than second and subsequent conduits and those inserted later in the series (p = 0.001 and 0.003, respectively). Overall survival of conduits at 5, 10, and 15 years was 84% (95% CL, 80% to 88%), 58% (95% CL, 50% to 66%), and 31% (95% CL, 19% to 43%). Corresponding figures for the first conduits were 88% (95% CL, 84% to 92%), 65% (95% CL, 56% to 73%), and 34% (95% CL, 20% to 47%). The longest surviving homograft conduit in our series lasted 22.7 years. Regarded univariately, reoperation (redo worse), order number (recent worse), type of conduit (pulmonary worse than aortic), preservation (cryopreserved worse than antibiotic preserved), and age at operation (older patients worse) were statistically significant. However, in multivariable analysis, including all the above in the model, only reoperation and order number had significant predictive power. When patient survival was considered, patients operated on more recently survived longer despite the fact that their conduits were being replaced earlier. Overall, survival of patients at 5 and 15 years was 95% (95% CL, 93% to 98%) and 85% (95% CL, 77% to 92%), respectively. CONCLUSIONS Pulmonary and aortic homografts, both cryopreserved and preserved in nutrient antibiotic solution, give similar results. All conduits will probably have to be replaced during the lifetime of the patient. In view of the worse performance of replacement conduits, techniques of repair that avoid the use of conduits should be further explored. Despite gradual deterioration of homograft conduits, they remain an important tool in the correction of many complex lesions with excellent 15-year patient survival.

Pulmonary atresia and intact ventricular septum: a revised classification.

The dismal outlook for patients with pulmonary atresia with intact ventricular septum may be related to associated right ventricular hypoplasia. Study of 32 autopsy specimens and 46 angiocardiograms of neonates with this lesion suggested that the cavitary hypoplasia was related to massive hypertrophy of the right ventricular wall. This hypertrophy was sufficient to obliterate the trabecular and/or infundibular portion of the ventricular cavity entirely in one‐third of the cases; this observation forms the basis for a revised classification of these hearts. Three autopsies and 14 angiograms of neonates with critical pulmonary stenosis were examined. Hearts with obliterated infundibular and trabecular cavities had thicker walls and smaller tricuspid valves, as estimated angiographically or at autopsy, than those in which the normal three portions of the ventricular cavity were represented.

Basal Pulmonary Vascular Resistance and Nitric Oxide Responsiveness Late After Fontan-Type Operation

Background—The pulsatile nature of pulmonary blood flow is important for shear stress–mediated release of endothelium-derived nitric oxide (NO) and lowering pulmonary vascular resistance (PVR) by passive recruitment of capillaries. Normal pulsatile flow is lost or markedly attenuated after Fontan-type operations, but to date, there are no data on basal pulmonary vascular resistance and its responsiveness to exogenous NO at late follow-up in these patients. Methods and Results—We measured indexed PVR (PVRI) using Fick principle to calculate pulmonary blood flow, with respiratory mass spectrometry to measure oxygen consumption, in 15 patients (median age, 12 years; range, 7 to 17 years; 12 male, 3 female) at a median of 9 years after a Fontan-type operation (6 atriopulmonary connections, 7 lateral tunnels, 2 extracardiac conduits). The basal PVRI was 2.11±0.79 Wood unit (WU) times m2 (mean±SD) and showed a significant reduction to 1.61±0.48 (P =0.016) after 20 ppm of NO for 10 minutes. The patients with nonpulsatile group in the pulmonary circulation dropped the PVRI from 2.18±0.34 to 1.82±0.55 (P <0.05) after NO inhalation. Conclusions—PVR falls with exogenous NO late after Fontan-type operation. These data suggest pulmonary endothelial dysfunction, related in some part to lack of pulsatility in the pulmonary circulation because of altered flow characteristics. Therapeutic strategies to enhance pulmonary endothelial NO release may have a role in these patients.

Identification of systems failures in successful paediatric cardiac surgery

Patient safety will benefit from an approach to human error that examines systemic causes, rather than blames individuals. This study describes a direct observation methodology, based on a threat and error model, prospectively to identify types and sources of systems failures in paediatric cardiac surgery. Of substantive interest were the range, frequency and types of failures that could be identified and whether minor failures could accumulate to form more serious events, as has been the case in other industries. Check lists, notes and video recordings were employed to observe 24 successful operations. A total of 366 failures were recorded. Coordination and communication problems, equipment problems, a relaxed safety culture, patient-related problems and perfusion-related problems were most frequent, with a smaller number of skill, knowledge and decision-making failures. Longer and more risky operations were likely to generate a greater number of minor failures than shorter and lower risk operations, and in seven higher-risk cases frequently occurring minor failures accumulated to threaten the safety of the patient. Non-technical errors were more prevalent than technical errors and task threats were the most prevalent systemic source of error. Adverse events in surgery are likely to be associated with a number of recurring and prospectively identifiable errors. These may be co-incident and cumulative human errors predisposed by threats embedded in the system, rather than due to individual incompetence or negligence. Prospectively identifying and reducing these recurrent failures would lead to improved surgical standards and enhanced patient safety.

Pulmonary atresia and intact ventricular septum: surgical management based on a revised classification.

Sixty patients with pulmonary atresia and intact ventricular septum (PA:IVS) presenting from 1970 to 1980 are reviewed. Three groups of patient are discussed: those with tripartite right ventricles, those with no trabecular portion to the cavity, and those with neither trabecular nor infundibular portions. The decrease in early mortality for neonates with PA:IVS since 1977 (one death in 15 patients) supports our current management policy of preoperative prostaglandin El infusion with transpulmonary valvotomy (for patients with an infundibular cavity) combined with a left modified Blalock‐Taussig shunt using a Gore‐Tex prosthesis. Tricuspid valve growth, estimated by serial angiograms in 12 patients, was greater if right ventricle‐to‐pulmonary artery continuity was established. Later definitive repair was attempted in nine patients, with two early deaths; five underwent right ventricular outflow tract reconstruction and four had modified Fontan procedures. Neonates with critical pulmonary stenosis are also discussed. Their neonatal mortality (nine deaths in 20 patients) was similar to that of comparable patients with PA:IVS, but their actuarial survival at 5 years (55%) was superior (36% at 5 years).

The Fontan Circulation: What Have We Learned? What to Expect?

Our knowledge of the Fontan operation tends to indicate that it remains a palliative procedure for patients with a functionally single ventricle. There is a continuing attrition and the life expectancy of these patients is likely to be different from the life expectancy of a population of individuals having a biventricular circulation. This article is an essay on the rational approach for the future management of these patients. It is suggested that a better understanding of the continuing Fontan attrition and a more subtle way to predict outcomes of patients who do receive the Fontan could help in establishing better selection criteria and designing ways to prevent, delay, or treat the side-effects of this late attrition.Abstract. Our knowledge of the Fontan operation tends to indicate that it remains a palliative procedure for patients with a functionally single ventricle. There is a continuing attrition and the life expectancy of these patients is likely to be different from the life expectancy of a population of individuals having a biventricular circulation. This article is an essay on the rational approach for the future management of these patients. It is suggested that a better understanding of the continuing Fontan attrition and a more subtle way to predict outcomes of patients who do receive the Fontan could help in establishing better selection criteria and designing ways to prevent, delay, or treat the side-effects of this late attrition.

Institutional resilience in healthcare systems

A recent report for the President of the United States described the impact of preventable medical errors as a “national problem of epidemic proportions”.1 Similar concerns have been echoed in the report of an expert group chaired by the Chief Medical Officer.2 In this report it was estimated that 400 people in the UK die or are seriously injured each year in adverse events involving medical devices, and that harm to patients arising from medical errors occurs in around 10% of admissions—or at a rate in excess of 850 000 per year. The cost to the NHS in additional hospital stays alone is estimated at around £2 billion a year. Safety has two faces. The negative face is very obvious and is revealed by adverse events, mishaps, near misses, and so on. This aspect is very easily quantified and so holds great appeal as a safety measure. The other, somewhat hidden, aspect offers a more satisfactory means of assessing safety. This positive face can be defined as the systems intrinsic resistance to its operational hazards. Some organisations will be more robust in coping with the human and technical dangers associated with their daily activities. This will be as true for healthcare institutions as it is for other systems engaged in hazardous activities. In short, some organisations will be in better “safety health” than others. The ideas of resistance and vulnerability can be represented as the extremes of a notional space termed the “safety space” (fig 1). The horizontal axis of the space runs from an extreme of maximum attainable resistance (to operational hazards) on the left to a maximum of survivable vulnerability on the right. A number of hypothetical organisations are located along this resistance vulnerability dimension. The cigar-shaped space shows that most organisations will occupy an approximately …

A numerical fluid mechanical study of repaired congenital heart defects. Application to the total cavopulmonary connection.

A computational fluid dynamics study based on the application of the finite element method has been performed to investigate the local hemodynamics of the total cavopulmonary connection. This operation is used to treat congenital malformations of the right heart and consists of a by-pass of the right ventricle. In this paper the adopted methodology is presented, together with some of the preliminary results. A three-dimensional parametric model of the connection and a lumped-parameter mechanical model of the pulmonary circulation have been developed. The three-dimensional model has been used to simulate the local fluid dynamics for different designs of the connection, allowing a quantitative evaluation of the dissipated energy in each of the examined configurations. The pulmonary afterload of the three-dimensional model has been reproduced by coupling it with the pulmonary mechanical model. The results show that, from a comparative point of view, the energetic losses can be greatly reduced if a proper hydraulic design of the connection is adopted, which also allows control of the blood flow distribution into the lungs.