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J Thorac Cardiovasc Surg 2007;134:710-716
© 2007 The American Association for Thoracic Surgery

Evolving Technology

Feasibility, safety, and efficacy of totally endoscopic coronary artery bypass grafting: Multicenter European experience

^a Department of Cardiac Surgery at Erasme University Hospital, Brussels, Belgium
^b Department of Cardiac Surgery, Klinikum der Johann Wolfgang Goethe Universität, Frankfurt am Main, Germany
^c Department of Cardiac Surgery, Dresden Herzzentrum, Dresden, Germany
^d Department of Cardiac Surgery, Onze Lieve Vrouwziekenhuis, Aalst, Belgium
^e Department of Cardiac Surgery, Leipzig Heart Institute, University of Leipzig, Leipzig, Germany
^f Intuitive Surgical Inc, Sunnyvale, Calif.

Received for publication September 27, 2005; revisions received May 16, 2006; accepted for publication June 9, 2006.

^_* Address for reprints: Didier de Cannière, MD, PhD, Chief of Cardiac Surgery, Erasme University Hospital, Department of Cardiac Surgery, 808 Route de Lennik, 1070 Brussels, Belgium. (Email: didier.decanniere{at}ulb.ac.be).

	Abstract

Top Abstract Introduction Materials and Methods Results Discussion Conclusions References

 
Objective: The invention of robotic systems has begun a new era of endoscopic cardiac surgery. Reports on totally endoscopic coronary artery bypass grafting are limited, however, and data regarding feasibility, safety, and efficacy are needed to determine this technique’s position in the therapeutic armamentarium. This study describes the largest multicenter experience in the literature with robotic totally endoscopic coronary artery bypass grafting specifically addressing procedural feasibility, safety, and efficacy.

Methods: Between September 1998 and November 2002, a total of 228 patients with coronary artery disease were scheduled for totally endoscopic coronary artery bypass grafting with the da Vinci Surgical System (Intuitive Surgical Inc, Sunnyvale, Calif.) at five European institutions. Patients underwent totally endoscopic coronary artery bypass grafting with either an on-pump (group A, n = 117) or an off-pump approach (group B, n = 111). Patients underwent postoperative angiography or stress electrocardiography and were followed up for 6 months.

Results: Procedural feasibility was demonstrated through the completion of 164 successful totally endoscopic cases. Sixty-four patients (group C, 28%) had conversion to nonrobotic procedures. Conversion rates decreased with time. The overall procedural efficacy, as defined by angiographic patency or lack of ischemic signs on stress electrocardiography, was 97%. The incidence of major adverse cardiac events within 6 months was 5%.

Conclusion: Both on- and off-pump totally endoscopic coronary artery bypass grafting are feasible, with a conversion rate that diminishes with increasing experience. Conversion does not adversely affect outcome and thus constitutes a safe alternative. Although target vessel reintervention may be slightly higher than that reported for open coronary artery bypass grafting, graft patency and major adverse cardiac events for both approaches are comparable to those reported in the Society of Thoracic Surgeons database, demonstrating the safety and efficacy of the totally endoscopic coronary artery bypass grafting procedure.

	Introduction

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Dr de Cannière

The continuous refinement of coronary artery bypass grafting (CABG) has led to a mature and efficient procedure that provides excellent long-term results for selected patients, with low mortality.^1,2 Standard CABG, however, is associated with significant invasiveness and large social, direct, and indirect costs.³ These limitations mandate further improvement. A novel procedure that uses robotic technology has been recently introduced into the operating room, enabling the performance of endoscopic coronary surgery.⁴ This procedure potentially offers the benefits of endoscopic surgery: avoidance of an aggressive chest incision, minimal blood–air interface, and minimal risk of infection, with a better cosmetic result and faster recovery and return to routine activity. Robotic surgery represents a major paradigm shift and challenge for the operative team.⁵ It requires the development of new technical skills, communication patterns, and conversion and contingency modalities, as well as overall changes in operative planning.^6-8 Since the world’s first procedure at the end of 1998, only limited patient numbers have been reported from single-center series.

This report describes the largest multicenter experience to date with robotic totally endoscopic CABG (TECAB). It specifically addresses feasibility, safety, and efficacy while discussing the potential value and limitations of TECAB.

	Materials and Methods

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Between September 1998 and November 2002, a total of 228 patients aged 18 to 80 years (59.2 ± 10.1 years) with significant symptomatic coronary artery disease were selected to undergo TECAB with the da Vinci Surgical System (Intuitive Surgical Inc, Sunnyvale, Calif) at five European institutions. The patients were categorized into three groups: on-pump TECAB (group A, 1.9 ± 0.8), off-pump TECAB (group B, 1.9 ± 0.8), and conversions (group C, 2.0 ± 0.8). A conversion was defined as the need for an incision (sternotomy or minithoracotomy) before the completion of the endoscopic anastomosis. A reintervention, even during the same operative session, after the completion of the anastomosis has been regarded as a major adverse cardiac event (MACE). All patients underwent 6-month postoperative follow up. In considering patients suitable for a robotic operation, the following exclusion criteria were applied: evidence of severely calcified left anterior descending coronary artery, contraindications for peripheral cannulation (group A), morbid obesity, decompensated congestive heart failure, and acute renal failure.

Overall, the vast majority (90%) had single-vessel disease, with the target vessel for revascularization being the left anterior descending coronary artery in 86%, a diagonal branch in 3%, and the right coronary artery in 1%. The remaining patients received either a sequential left internal thoracic graft to the diagonal and left anterior descending arteries (6%) or a double thoracic graft to the left anterior descending artery and the circumflex artery, diagonal, or right coronary artery (4%). Sixty percent had a history of percutaneous intervention to the left anterior descending artery before TECAB, whereas 15% underwent TECAB as a part of a hybrid procedure. All institutions completed the majority of their on-pump TECAB experience (group A) before proceeding to their off-pump TECAB experience (group B) and performed at least 30 cases. In group A, the left internal thoracic artery was harvested, the pericardium was opened, and the target vessel was identified before femoral cardiopulmonary bypass was instituted. The operative techniques have been described previously.^9,10 In group A, the CABG was performed under endoaortic balloon clamping and cardioplegic arrest, with a running suture to anastomose the thoracic conduit to the target vessel. In group B, an endoscopic stabilizer was inserted through a subxyphoid port after the thoracic harvesting and pericardial opening for stabilization of the target vessel and performance of the anastomosis on the beating heart.

All the operations were performed after obtaining written informed consent from the patient, in accordance with the ethics committees of each participating institution.

Feasibility, Efficacy, and Safety Assessment
The feasibility of the procedure was assessed by the ability to successfully complete TECAB without the need for conversion to any kind of open-chest procedure. The rate, reasons, and evolution of conversions are described in Tables 1 and 2 and in Figure 1. The efficacy of the procedure was measured by postoperative angiography, stress electrocardiography (ECG), or both. Angiographic efficacy was defined with a modified FitzGibbon criteria of less than 50% stenosis of the distal anastomosis for a patent graft. A clinically negative stress test result for ECG, defined by the absence of angina and ST-wave changes, was used as a surrogate measure for graft patency. Procedural safety was measured by the incidence of MACEs within a 6-month postoperative period. MACE variables included all-cause mortality, myocardial infarction, and target vessel reintervention. Perioperative incidence of MACE was compared with that in a matched cohort from the Society of Thoracic Surgeons (STS) National Database for open chest procedures performed for isolated single-vessel disease between 2000 and 2002. To assess longer term recurrence of MACEs, a random sample of 100 patients was contacted during the reviewing period of the article, at an average follow-up of 3.5 years.

View larger version (12K): [in this window] [in a new window]   Figure 1. Operation period represents 6 discrete 8-month intervals in which on-pump (group A) and off-pump (group B) conversion rates are shown. Numbers in histogram represent total number of cases performed during period.

Statistical Methods
The study was designed and powered to achieve an overall procedural efficacy of 94%, with a lower limit of the 95 percent confidence interval of at least 90%. All analyses were conducted according to an intent-to-treat principle. The data provided from the STS National Database used for perioperative comparisons of MACE frequency were based on a custom query of a patient population undergoing sternotomy CABG for isolated single-vessel disease. Patients were matched on the basis of age, sex, and preoperative risk factors. Although this comparison is provided as a baseline reference, it is not possible to draw meaningful statistical comparisons because of demographic differences of the two populations. Patients who did not undergo postoperative angiography or stress ECG were excluded from the efficacy analysis. Categorical variables are expressed as number and percentage of patients and were analyzed with the Fisher exact test or ² test for association, with or without continuity correction.

Continuous variables were compared with a two-sample t-test. A log–rank test was used to compare Kaplan–Meier curves of freedom from MACE.

	Results

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A total of 228 subjects were intended to undergo TECAB. One hundred sixty-four patients underwent completion of a totally endoscopic operation, whereas 64 patients (28%), denoted as group C, had intraoperative conversion to an alternate (nonrobotic) technique for completion of the procedure. The total numbers of patients, stratified by group and conversion mode, are shown in Table 1. There were no significant differences in conversion rate between groups A and B. The individual reasons for conversion among patients in group A and B are explained in Table 2. Most conversions in group A were due to cannulation, whereas conversion in group B occurred as the result of inadequate stabilization, inappropriate patient conditions, or bleeding at the anastomosis. The evolution of the conversion rates through discrete 6-month time intervals for the study period is shown in Figure 1. Twelve patients were unavailable for follow-up within the 6 month period.

The efficacy of the TECAB procedure, as measured by the FitzGibbon definition of patency (<50% stenosis), was 96%, described in Table 3 for patients without conversion. Postoperative angiographic controls were not systematically performed except in the case of hybrid procedures. One hundred grafts were assessed in 93 patients who did not have conversion; 17 grafts were assessed in 15 patients who had conversion (group C). Among patients who did not undergo angiography, 48 had completed a stress ECG test. The overall efficacy of TECAB as assessed by stress test alone was 98%. The combined procedural efficacy, as defined for patients having had either test, was 97% for all patients undergoing TECAB. In patients who had conversion, the combined procedural efficacy was 97.7%. There were no statistically significant differences in procedural efficacy across the three groups.

View larger version (7K): [in this window] [in a new window]   Figure 2. Kaplan–Meier curves for 6-month freedom from major adverse cardiac events (MACEs). Log–rank test shows no difference between groups A and B (P = .64), nor groups A and C (P = .26), nor groups B and C (P = .09).

Two patients (1%, 1 in group A and 1 in group B) had a myocardial infarction within 7 days after the operation. Myocardial infarction rates did not statistically differ across groups A and B and did not exceed the rates found with open CABG. Six patients underwent target vessel reintervention in the 6-month postoperative period. Five underwent surgical reintervention; the remaining patient underwent stent placement. Of the reinterventions, 2 occurred in group A, 3 in group B, and 1 in group C (2%, 4%, and 1%, respectively). There was no statistically significant difference in the incidence of target vessel reintervention. At a mean follow up of 3.5 years of 100 randomly selected patients, 4 had MACEs: 2 underwent percutaneous coronary intervention of a nontarget vessel, 1 had a myocardial infarction, and 1 had died from an unknown cause. No patient had undergone surgical target vessel reintervention.

	Discussion

Top Abstract Introduction Materials and Methods Results Discussion Conclusions References

 
This study is limited by its retrospective nature and provision of only a 6-month follow up. It represents a multicenter collaboration in which 228 patients underwent TECAB. Its purpose was to demonstrate feasibility, efficacy, and safety of the endoscopic procedure on both the arrested and beating heart. A significant learning curve was observed. Patency rates and 6-month freedom from MACE revealed acceptable results which were comparable to those from the STS National Database. Although the institutions continue to perform TECAB, the period of September 1998 through November 2002 represents that in which the study took place and a sufficient sample size was obtained to study graft patency and safety of the procedure, as requested by the regulatory approval. Although patients in this study may in fact have had longer follow up available, the 6-month time frame was chosen as a reasonable point within which MACEs and graft patency would be assessed.

TECAB represents a new challenge, requiring development of technical ability to work in an endoscopic environment. A conversion strategy and contingency plan therefore must be choreographed to bring the operation back to the surgical standards in case of need.¹¹

In the on-pump group (group A), which required femoral cannulation and endoaortic balloon clamping, 55% of the conversions were related to cannulation issues and were related to neither the da Vinci system nor the endoscopic nature of the operation itself. The management and monitoring of the endoaortic balloon clamp were made awkward in the presence of the da Vinci system and generated significant "strategic" issues, such as the sequence of cannula insertion and anticoagulation with regard to the robotic steps of the procedure. This contributed to an unexpectedly high rate of conversion for surgical teams with significant endoscopic CABG experience.^12,13 Such conversions might have been categorized as intraoperative exclusions, never destined to be completed robotically, resulting in a significantly lower conversion rate; however, they are reported as conversions per our intent-to-treat principle and represent an evolutionary process.

In group B, 3 of 4 conversions were related to the target vessel (wall calcification, intramyocardial course, bleeding from the arteriotomy, and inadequate stabilization). It is likely that the small percentage of hemodynamic intolerance in group B (4.8%) was due to a combination of factors specific to this procedure: the coexistence of carbon dioxide insufflation and stabilization, coupled with some degree of hypoxemia in the event of single-lung ventilation with insufficient compensation, and a potentially longer period of target vessel occlusion.¹⁴ With the exception of hemodynamic instability, which may be present in a fixed percentage of cases, other reasons for conversion can be specifically addressed. A significantly improved endoscopic stabilizer has been a considerable asset for the global success of the procedure. Target vessel localization is improving with time with the development of endoscopic skills, and specific navigation software is currently under development to facilitate target vessel identification.¹⁵ Special silicone elastomer snares have been designed to minimize bleeding at the arteriotomy site. Conversion modalities were different in groups A and B (Table 1). Fourteen of 27 conversions in group A were performed off-pump through a lateral thoracotomy, whereas 34 of 37 patients in group B had conversion to a lateral thoracotomy off-pump procedure. This conversion modality, known as robotically enhanced minimally invasive direct coronary artery bypass grafting, is regarded by some authors as the best operation for single left anterior descending revascularization.¹⁶ It is noteworthy that 54 of the 64 patients with conversions (84%) received a minimally invasive operation. Although the participating centers initially started with on-pump TECAB, this procedure was later abandoned in favor of off-pump TECAB in the case of single-vessel revascularization.

The efficacy of surgical revascularization can be addressed in different ways. The criterion standard is the angiogram demonstrating graft patency, eventually combined with a surrogate assessment of the functional completeness of revascularization confirming the adequacy of the therapeutic plan.¹⁷ The overall rate of TECAB procedural efficacy was 97%. It did not vary significantly between groups A and B, confirming that it is effective and within the expected range for a thoracic to left anterior descending graft.^18,19 Furthermore, the postoperative outcomes of the patients are unchanged regardless of whether the procedure is endoscopic or converted to an alternate technique.

The specific skills that are required to perform an endoscopic anastomosis on an arrested heart can easily be developed on isolated animal hearts. Training on such models has taken place at each institution. On the other hand, theoretic concerns have been raised about the efficacy of off-pump TECAB.²⁰ The interposition of the robotic system introduces a delay between the surgical gesture and the motion of the telemanipulated instrument. This delay theoretically affects the precision of tasks performed on the beating heart, such as suture placement, so that even with an adequate visualization of the suture line, the quality of the anastomosis might be in question. This theoretic drawback cannot be solved unless perfect stabilization is achieved. It may also be overcome with the venue of anastomotic connectors that are currently under clinical development. The results of off-pump TECAB, however, as addressed through angiographic controls, have been shown to be satisfactory and to fall within the expected range for thoracic grafting.^18,19 With confidence limits of combined efficacy ranging from 91% to 100%, off-pump TECAB is a viable therapeutic option.

The assessment of procedural safety shows that the incidence of MACE was similar between groups. Direct comparison of the overall incidence of MACE with that in the STS database is difficult because of the unknown multiplicity of coexisting adverse events among patients in the STS database. This comparison is for information purposes until prospective, randomized procedures are available. It needs to be mentioned that it takes place in the learning curve of TECAB, that the STS cohort is matched for the on and off pump cases but includes only single bypasses and that the patients of the TECAB cohort may have been followed up more closely, so that the comparison may be the worse case scenario for TECAB. Mortality and myocardial infarction are not affected by the endoscopic approach versus the STS database. On the other hand, concerns regarding a potentially higher incidence of target vessel reintervention for endoscopic procedures must be weighed against the benefits of a minimally invasive approach. In the longer term, the place of the totally endoscopic procedures in the therapeutic armamentarium against coronary artery disease will also require comparison to the existing alternatives of CABG such as the robotic-enhanced minimally invasive direct CABG or ACAB.¹⁶

	Conclusions

Top Abstract Introduction Materials and Methods Results Discussion Conclusions References

 
Although endoscopic CABG represents a major paradigm change, leading to difficulties that must not be underestimated, the results of this study demonstrate that on-pump and off-pump TECAB are feasible, with a conversion rate that diminishes with increasing experience. Conversion does not adversely affect outcome and thus constitutes a safe alternative. Although the rate of target vessel reintervention may be slightly higher than that reported for open CABG, graft patency and major adverse cardiac events for both approaches are comparable to those reported in the STS database and demonstrate that TECAB is a safe and effective procedure. Future prospective studies and longer follow-up may address the benefits of successful TECAB with respect to conventional CABG.

See related editorials on pages 559 and 562.

 

	Acknowledgments

 
Dr de Cannière thanks the Fonds pour la Chirurgie Cardiaque and LIVE for supporting the robotic program at Erasme Hospital.

	Footnotes

 
This study was sponsored by Intuitive Surgical Inc, the manufacturer of the da Vinci robotic surgical system used by the five centers contributing to this report. U.S.-K. is a full-time employee of Intuitive Surgical.

	References

Top Abstract Introduction Materials and Methods Results Discussion Conclusions References

 

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Didier de Cannière Gerhard Wimmer-Greinecker Romuald Cichon Vassilios Gulielmos Frank Van Praet Volkmar Falk Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by de Cannière, D. Articles by Falk, V. Search for Related Content PubMed Articles by de Cannière, D. Articles by Falk, V. Related Collections Related Articles