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J Thorac Cardiovasc Surg 2008;135:857-862
© 2008 The American Association for Thoracic Surgery
Surgery for Acquired Cardiovascular Disease |
Herzzentrum Dresden, Dresden, Germany
Received for publication May 3, 2007; revisions received November 7, 2007; accepted for publication November 13, 2007. * Address for reprints: Utz Kappert, MD, Herzzentrum Dresden, Fetscherstr 76, D-01307 Dresden, Germany. (Email: u.kappert{at}herzzentrum-dresden.com).
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Abstract |
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 Top Abstract IntroductionPatients and MethodsResultsDiscussionConclusionsLimitationsReferences |
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Methods: From May 1999 to June 2001, 41 patients (36 male, 5 female; mean age 60.6 ± 8.9 years) underwent totally endoscopic coronary artery bypass for isolated high-grade lesions of the left anterior descending coronary artery by means of the da Vinci system (Intuitive Surgical, Inc, Mountain View, Calif). Clinical follow-up was performed 5 years after the operation. End points of the follow-up were freedom from major adverse events such as death, myocardial infarction, and repeated revascularization of the left anterior descending artery.
Results: Hospital survival was 100%. Overall survival after 5 years was 92.7% (38/41 patients). Three (7.3%) patients died of noncardiac causes. Freedom from reintervention of the left anterior descending artery after a mean of 69 ± 7.4 months was 87.2% (36/41 patients). Freedom from any major adverse events during the whole follow-up was 75.7% (31/41 patients).
Conclusion: Endoscopic surgery on the beating heart remains the ultimate goal for minimally invasive coronary artery surgery. The clinical outcomes and need for reintervention of the target vessel leave room for improvement and may be considered reflective of early experiences typically associated with dramatic departure from conventional therapy. Moving forward, advances in instrumentation and anastomotic technology seem to be essential for reproducible and reliable coronary anastomosis in a totally endoscopic approach.
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Introduction |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionConclusionsLimitationsReferences |
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These design criteria were validated in the initial clinical trials resulting in European and Food and Drug Administration approval for minimally invasive cardiac surgery. These early trials mainly focused on initial outcomes until hospital discharge.1-4
Long-term assessment of this surgical approach is still pending. The Heart Center Dresden was one of the early adopters of this technology and performed the TECAB procedure in a number of patients requiring single-vessel revascularization, initially on-pump and later using the off-pump technique.3 The following describes the 5-year clinical results from this initial single-center TECAB series.
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Patients and Methods |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionConclusionsLimitationsReferences |
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Demographic data of these patients are presented in
Table 1 and show that this patient cohort presented a low rate of comorbidities and risk factors, as illustrated by the comparably low EuroSCORE of 2.1 ± 0.1. The operative data regarding target vessel and conduit selection are shown in
Table 2.
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Figure 1).
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Sampling of data was accomplished by reviewing hospital records and by performing a telephone interview with the patient directly, the patients' relatives, or the patients' referring physicians.
This clinical evaluation was approved by the ethics committee of the University of Leipzig ("Study on the Clinical Use of a Telemanipulator in Minimally Invasive Cardiac Surgery"; Int. Reg. No. 721, approval date May, 19, 1998).
Data collected included mortality, myocardial infarction, and reintervention of the LAD. The presence of a myocardial infarction was determined on the basis of electrocardiographic changes, elevated troponin I levels, and creatinine/creatinine myoglobin fractions. These end points were incorporated into an overall assessment of the incidence of major adverse events. Major adverse cardiac events (MACE) were defined as myocardial infarction, reintervention of the LAD, and cardiac-related mortality.
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Results |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionConclusionsLimitationsReferences |
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Two myocardial infarctions (4.8%) occurred in the follow-up period. One myocardial infarction occurred within the first 6 months after the operation and the other 19 months postoperatively. In both cases the infarct was not located within the region of the bypassed target vessels.
Postoperative angiograms are available from 14 (35%) patients. Reintervention of the LAD was necessary in 5 (12.2%) patients. Two (4.8%) patients required reoperation of the target vessel for graft occlusion. Surgical revascularization was performed by the median sternotomy approach. Two patients received an angioplasty of the LAD (4.8%) owing to significant anastomotic stenosis and in 1 patient owing to a de novo lesion of the distal LAD. Freedom from reintervention of the LAD was 87.8% after a median of 69 months. On the basis of all available postoperative angiography data, the overall patency rate of the LAD was 71.4% (10/14).
Overall freedom from major adverse events for this follow-up was 31 (75.6%) of 41, excluding noncardiac death (34/41, 82.9%;
Figure 2). Overall results are displayed in
Table 3.
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Discussion |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionConclusionsLimitationsReferences |
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The freedom from MACE excluding noncardiac-related death was 82.9%. The small number of patients studied, the lack of angiographic follow-up in this report, and the lack of other long-term clinical follow-up studies after TECAB procedures in the medical literature make it difficult to interpret these results. In 2007, Holzhey, Jacobs, and Mochalski5 reported results from a 7-year follow-up study in 1300 patients after minimally invasive direct coronary artery bypass (MIDCAB) where the freedom from MACE was 83%. In 2006, Argenziano, Katz, and Bonatti4 reported from a multicenter study on the safety and efficacy of the da Vinci system. In this study, patients underwent a robotic TECAB procedure on-pump. There was no mortality and low morbidity. Three-month angiography, performed in 76 patients, revealed significant anastomotic stenoses (>50%) or occlusions in 6 patients. Overall freedom from reintervention or angiographic failure was 91%.
Up to now, endoscopic revascularization on the beating heart has not translated into a routine procedure within the past 6 years, although significant progress in the technical aspects of the procedure have certainly been made.
The need for high-quality outcomes in conjunction with the use of innovative concepts such as robot-assisted surgery will continue to require a significant technologic and intellectual investment to ensure reproducibility of such a complex procedure.
With the rapid evolution of surgical techniques and technologies, the optimal treatment of isolated LAD disease remains extensively debated. Durability and invasiveness of the surgical approach have to be balanced with the relatively less invasive percutaneous treatment, which is often associated with the need for repeat revascularization procedures.6
The main focus of any bypass procedure, regardless of the technique used, should be on the quality of the coronary anastomosis. In 2003, Jacobs and associates7 presented data describing limitations of telemanipulators such as incomplete motion tracking, delays in tracking, and information tracking. These limitations are likely to negatively affect the quality of an anastomosis, particularly in beating-heart surgery. Surprisingly, in our cohort no significant differences concerning the outcome of on- and off-pump operations could be detected. This might be due to the small number of patients.
Progress in many of these areas has resulted in much lower conversion rates in later series.4 However, to meet the high standards of coronary revascularization, the anastomotic technique should be adjusted to meet the needs of intrathoracic limited space surgery.
In a review of modern anastomotic technology, Carrel8 correctly stated that the surgical limitations of the minimally invasive revascularization procedure are related to the inability to perform a conventional hand-sewn coronary anastomosis. He mentioned that there is an urgent need to define the performance objectives of such systems as well as the general criteria for proper and comparable evaluation and validation of different systems in animal models and subsequently in controlled prospective clinical studies.
In 2005 our group9 published the results from the pivotal clinical trial using the Cardica C-Port distal anastomosis system (Cardica Inc, Redwood City, Calif). Despite the use of this novel device in often small coronary targets with inferior runoff, the discharge and 6-month angiographic patency results were found to be superior to historical data from the published literature on vein graft patency using conventional hand-sewn techniques. We believe this technology offers a lot of promise for resurgence in TECAB.
Besides anastomotic technology and refinements in stabilization systems, further improvements in technology will be needed. Target vessel identification can be challenging in some patients.10 Bonatti and associates11 summarized technical difficulties their group has encountered in TECAB procedures. These included difficulties with port hole placement, port hole bleeding, left internal thoracic artery damage during harvesting, epimyocardial lesions during target vessel preparation, problems with the anastomoses, and, in patients undergoing on-pump operations, technical difficulties with cannula and occlusion balloon placement. It is therefore safe to say that intense technologic and procedure-related development will be necessary to reduce the rate of undesirable events and to significantly improve the ease of use.
Currently, TECAB procedures add significantly to the overall procedure costs. This has also been true for the introduction of radically different procedures such as laparoscopic and thoracoscopic interventions. Although initially this may appear prohibitive, in the latter two examples it has not hindered a change in operative standards, and with time and sufficient procedural volume, the costs tend to come down and can often be justified by a reduction in hospital stay, patient morbidity, and a dramatic decrease in invasiveness. We therefore believe it would be premature to discard the development of TECAB procedures at this time on the basis of current health care economics.
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Conclusions |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionConclusionsLimitationsReferences |
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We strongly believe that as cardiac surgeons we have a mandate to continue to refine our technique with the end goal of developing a standard on- or off-pump TECAB procedure for routine use in patients with isolated high-grade LAD lesions. The combination of the excellent coronary artery bypass graft outcomes with a truly less invasive procedure is clearly beneficial to patients.
Limitations of this study include the lack of angiographic patency assessment in the majority of the patients studied. The small number of patients also limits the final conclusions that can be drawn from this experience.
The challenge will be how to refine the technique and accelerate the learning without compromising short- and long-term outcomes. The clinical outcomes in these procedures need to be comparable with those obtained after other minimally invasive surgical revascularization strategies for isolated LAD lesions4,5 to justify further exploration of this endoscopic form of therapy. However, there is significant room for improvement, and we believe further technical developments, such as anastomotic devices, are mandatory to achieve the patency and morbidity outcomes we have become accustomed to obtaining after the standard sternotomy approaches.
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Limitations |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionConclusionsLimitationsReferences |
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The implementation of a completely new device, technique, and surgical approach was certainly associated with a learning curve in all steps of the procedure, especially with regard to the endoscopic creation of the vascular anastomosis, which included learning how to identify, dissect, and control the target vessel.
Commercially available endoscopic stabilizers had not yet been developed; therefore, the quality of the anastomoses was probably negatively affected by the use of these early endostabilizer prototypes (Figure 1). The procedure was evolving during this initial series, resulting in a large number of variations in the surgical techniques used.
The data obtained were from a single center; therefore, our technique did not benefit from the knowledge obtained by other centers during the same period. Follow-up obtained in this series was restricted to clinical outcome and did not include complete long-term angiographic assessment of patency. Finally, the number of patients enrolled was small.
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Footnotes |
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References |
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TopAbstractIntroductionPatients and MethodsResultsDiscussionConclusionsLimitationsReferences |
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This article has been cited by other articles:
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  J. Bonatti, T. Schachner, N. Bonaros, E. J. Lehr, D. Zimrin, and B. Griffith Robotically Assisted Totally Endoscopic Coronary Bypass Surgery Circulation, July 12, 2011; 124(2): 236 - 244. [Full Text] [PDF]
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 P. Modi, E. Rodriguez, and W. R. Chitwood Jr. Robot-assisted cardiac surgery Interact CardioVasc Thorac Surg, September 1, 2009; 9(3): 500 - 505. [Abstract] [Full Text] [PDF]
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 C. Gao, M. Yang, Y. Wu, G. Wang, C. Xiao, H. Liu, and C. Lu Hybrid Coronary Revascularization by Endoscopic Robotic Coronary Artery Bypass Grafting on Beating Heart and Stent Placement Ann. Thorac. Surg., March 1, 2009; 87(3): 737 - 741. [Abstract] [Full Text] [PDF]
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