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Ann Thorac Surg 2003;76:749-753
© 2003 The Society of Thoracic Surgeons
a Division of Cardiac Surgery, London Health Sciences CenterLondon, Ontario, Canada
b Department of Clinical Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada
c Department of Surgery, Cleveland Clinic Florida, Weston, Florida, USA
Accepted for publication April 3, 2003.
* Address reprint requests to Dr Novick, Division of Cardiac Surgery, London Health Sciences Center, University Campus, P.O. Box 5339, 339 Windermere Road, London, Ontario, Canada N6A 5A5
e-mail: rjnovick{at}uwo.ca
| Abstract |
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METHODS: Ninety patients underwent internal thoracic artery (ITA) takedown and an attempt at ITA to coronary bypass on the beating heart using the Zeus telerobotic system from September 1999 to December 2001. The rates of mortality and 11 predefined major complications were compared in five quintiles of 18 consecutive patients each and a CUSUM curve was generated for the entire cohort.
RESULTS: All patients but one underwent successful endoscopic ITA takedown. Thirteen patients had a totally endoscopic anastomosis, whereas in 61 a small mini-thoracotomy or mini-sternotomy was used. Sixteen patients (17.8%) were converted electively to a sternotomy: 11 patients underwent off-pump and 5 patients on-pump surgery. There were no deaths; 13 patients (14.4%) incurred one or more of the 11 major complication(s), including 5, 1, 2, 3, and 2 in each of the five quintiles (p = 0.39). Standard statistical analyses identified a significant decrease in operating room time (p < 0.0001), as well as a decrease in the incidence of an occluded graft or wrong vessel grafted from quintiles 1 to 5 (p = 0.03). On CUSUM analysis, the failure curve was steep for the first 18 to 20 patients, before moderating its slope for the remainder of the experience.
CONCLUSIONS: Robotic ITA to coronary bypass on the beating heart has a moderately steep learning curve, which is mitigated by further experience. CUSUM analysis complimented standard statistical methods in detecting a cluster of suboptimal results during the early experience with this procedure.
| Introduction |
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Recent publications from our center have examined the learning curve in a 10-year experience with on-pump cardiac surgery [9], as well as in the transition from on-pump to off-pump CABG [10, 11]. In all three of these articles we used the cumulative sum (CUSUM) failure method to detect a cluster of surgical failures and successes in advance of standard statistical analyses. Before embarking on our clinical experience with telerobotic CABG in 1999, we decided to assess our learning curve prospectively using both standard statistical and CUSUM failure methods. Our a priori hypothesis was that there would be an important learning curve in the development of this procedure, which would be quickly mitigated by subsequent experience.
| Patients and methods |
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Patients in this series underwent telerobotic CABG using the ZEUS Robotic Surgical System (Computer Motion, Inc., Goleta, CA). Permission to embark on this trial was granted by the Research Ethics Board of the University of Western Ontario after a detailed review and all patients gave fully informed, written consent for the procedure. The operative methods used have been described in detail in recent publications from our center [7, 12].
The outcomes measured in the study included postoperative mortality and the following 11 predefined major complications: perioperative myocardial infarction, reoperation for bleeding, stroke, mediastinitis, sepsis, life-threatening arrhythmia, new renal failure, need for postoperative intraaortic balloon pump support, the requirement for mechanical ventilation for greater than 48 hours postoperatively, and an occluded graft or wrong vessel grafted on postoperative assessment. The operational definitions of these complications have been defined in previous reports from our center [9, 10]. In addition, we measured operating room times, the requirement for conversion to sternotomy and postoperative intensive care unit and the hospital length of stay. Postoperative coronary and graft arteriography was performed in most patients before discharge home; those who did not undergo postoperative coronary arteriography underwent a detailed Doppler ultrasound assessment of the internal thoracic artery grafts early postoperatively.
To more sensitively assess the learning curve in this series, the 90 patients were divided into five quintiles of 18 consecutive patients each. Statistical differences among groups were assessed using Fishers exact tests for categorical outcomes and analysis of variance for continuous outcomes. Furthermore, a running CUSUM method was used to assess the cumulative failure rate (i.e., the rate of mortality, predefined major complications and poor graft outcomes on postoperative coronary arteriography), as in our recent reports [911]. For this study we used a maximum acceptable failure rate of 10% for the sum of all three of these adverse outcomes because this value has been used as a benchmark in our previous studies. Furthermore, recent publications on the early outcomes of CABG procedures have revealed major complication rates of 14% to 15% after on-pump CABG versus 8.8% to 10.6% after off-pump CABG [1, 2]; our target was directed toward the lower end of this range. In addition to CUSUM analyses, observed versus expected lengths of postoperative hospital stay were calculated using the multivariable logistic regression model of the Cardiac Care Network of Ontario [13]. A p value less than 0.05 was considered significant.
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| Results |
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The incidence of major complications and poor graft outcomes in each 18-patient quintile is illustrated in Table 4. Four of 5 patients with adverse graft outcomes were operated in the first quintile and only 1 patient in quintiles two to five. As indicated in Table 4, there was no statistical difference among groups in the incidence of major complications or adverse graft outcomes. However, if the two types of poor graft outcomes were combined, the difference among quintiles was significant (p = 0.03).
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The CUSUM failure curve for the entire cohort is illustrated in Figure 1. CUSUM analysis revealed a relatively steep curve early in our experience, with five "failures" (i.e. patients with major complications) in the first 18 patients. The slope of the curve then moderated significantly, such that by the end of the experience there were a total of four adjusted CUSUM failures in the entire cohort, using a maximum acceptable failure rate of 10% as a benchmark.
| Comment |
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Although the cardiac surgeon is usually the catalyst for the development and refinement of telerobotic CABG, the importance of a dedicated anesthesiology, nursing, cardiology, and postoperative care team cannot be overemphasized. Furthermore, in our institution, surgical endoscopic skills learned from prior experience of harvesting the ITA using a voice-controlled robotic endoscopic positioner and the harmonic scalpel [6] facilitated the transition to full, telerobotic CABG. This previous operative experience and the efforts of a dedicated team led to a highly significant decrease in operating room times throughout our 90 patient experience. Moreover, our anesthesiology and postoperative care teams facilitated the "fast-track" convalescence of these patients, resulting in relatively brief stays in the intensive care unit and in the hospital, even though most of these patients underwent postoperative cardiac catheterization. The median postoperative length of stay of our patients, at 4.0 days, was approximately 25% less than predicted using the multivariable logistic regression model of the Cardiac Care Network of Ontario. Furthermore, this length of stay was 1 day shorter than that of patients undergoing multivessel off-pump CABG through a sternotomy at our institution [11]. Moreover, almost all of the 74 patients who underwent limited access, telerobotic procedures were able to return to full activities within 2 weeks of surgery.
Other centers have reported their early experience with endoscopic robot-assisted CABG using either on-pump, arrested heart methods [8, 1416], or by closed-chest beating heart techniques [4, 17]. Damiano and associates [16] reported an intraoperative anastomotic revision rate of 9% and an incidence of 9% of reoperation for bleeding, versus a 3.3% anastomotic reintervention rate and a 2.2% reoperation for bleeding rate in our series. Recently, Dogan and associates [8] reported an intraoperative conversion to minithoracotomy or sternotomy rate of 22.3%, which decreased to 5% in the last 20 patients. These investigators noted further that "the majority of complications occurred in the first 20 patients of this series and are clearly attributable to the learning curve" [8]. The recently reported experience from Leipzig recorded an 18.5% conversion rate to sternotomy or thoracotomy when totally endoscopic robotic-assisted CABG was performed on the arrested heart [4]. On the other hand, 6 of the first 8 patients undergoing an attempt at totally endoscopic CABG on the beating heart required conversion to sternotomy or minithoracotomy. Thus, it is clear that even in the most experienced hands limited-access, telerobotic CABG involves a significant learning curve. Nonetheless, as demonstrated by the Leipzig data [4] and the results of our own study, procedural times and adverse clinical events can be significantly reduced with increasing experience.
The CUSUM method was introduced in the 1950s as a procedure for detecting changes in the frequency of failures, by the repeated application of a sequential probability ratio test [18, 19]. The CUSUM technique recognizes the importance of time as a "hidden variable" in clinical studies [20] and avoids statistical problems associated with repeated significance testing [21]. We have used CUSUM methods since 1999 to evaluate patient outcomes and learning curves in adult cardiac surgery [911]. Our earlier studies demonstrated that CUSUM methods were a more sensitive indicator of a cluster of surgical failures than standard statistical techniques. In this study the CUSUM curve had a steep slope during the first 18 to 20 patients before moderating. Standard statistical analysis did not reveal a significant difference in cumulative major complication rates between quintiles, although the incidence of combined poor graft outcomes on postoperative coronary arteriography was significantly higher in quintile 1 patients. Furthermore, analysis of variance did demonstrate statistically significant decreases in procedural times from quintiles 1 to 5. Thus, in this study, CUSUM and standard statistical methods provided complimentary information to assist members of the surgical team in gauging the rapidity of the learning curve in a complex, highly innovative surgical procedure.
As noted in a recent review on computer-enhanced and telerobotic CABG [12], the current role of this procedure has not been fully defined. Although the further development of robotic technology has immense long-term potential to minimize morbidity and improve the outcomes of CABG procedures, only highly specialized centers can presently afford the extensive financial investment that is required to use robotic systems in this setting. It is our hope that further reductions in perioperative morbidity and postoperative length of stay will make telerobotic CABG surgery more cost effective. Furthermore, the application of telecommunication technologies to this field will facilitate information transfer between surgical centers and accelerate the diffusion of new robotic surgical techniques [12]. These new surgical methods will, in turn, need to undergo thorough and dispassionate analysis using standard statistical and CUSUM methods to ensure that short-term outcomes meet current expectations. Moreover, patients undergoing these procedures must be followed indefinitely to further define long-term graft quality and freedom from adverse clinical events.
| Acknowledgments |
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| References |
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