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Ann Thorac Surg 2003;75:438-443
© 2003 The Society of Thoracic Surgeons
a Department of Surgery and the Center for Minimally Invasive and Robotic Surgery, Greenville, North Carolina, USA
b Department of Medicine, Greenville, North Carolina, USA
c Department of Statistics, Brody School of Medicine at East Carolina University, Greenville, North Carolina, USA
* Address reprint requests to Dr Chitwood, Department of Surgery, Brody School of Medicine, East Carolina University, 600 Moye Blvd, Greenville, NC27858, USA
e-mail: chitwoodw{at}mail.ecu.edu
Presented at the Thirty-eighth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 28–30, 2002.
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Abstract |
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METHODS: Eligible patients had nonischemic moderate to severe mitral insufficiency. Operative techniques included peripheral cardiopulmonary perfusion, a 4- to 5-cm mini-thoracotomy, transthoracic aortic occlusion, and antegrade blood cardioplegia. Transesophageal echocardiograms were done intraoperatively with three-dimensional reconstructions. Successful repairs were defined as mild or less residual regurgitation.
RESULTS: Enhanced three-dimensional visualization of mitral leaflets and the subvalvar apparatus allowed safe, dexterous intracardiac tissue manipulation. All patients had successful valve repairs including quadrangular resections, sliding plasties, and edge-to-edge approximations, as well as both chordal transfers and replacements. There were no operative deaths, strokes, or device-related complications. One patient required valve replacement for hemolysis and 1 was reexplored for bleeding. There were no incisional conversions. Both robotic repair and total operating times decreased significantly from 1.9 ± 0.1 and 5.1 ± 0.1 hours (mean ± standard error of the mean) for the first 19 patients to 1.5 ± 0.1 (p = 0.002) and 4.4 ± 0.1 hours (p = 0.04) for the last 19 operations, respectively. Total hospital length of stay for patients was 3.8 ± 0.6 days. Of all patients, 31 (82%) had a 4-day or less length of stay. Seven patients (18%) had stays between 5 and 9 days (6.4 ± 1.0).
CONCLUSIONS: This study shows that the da Vinci surgical system (Intuitive Surgical, Inc) has few limitations in performing complex valve repairs. Articulated wrist-like instruments and three-dimensional visualization enabled precise tissue telemanipulation. Future robotic design advances and adjunctive suture technologies may promote continuing evolution of robotic cardiac operations.
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Introduction |
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| Drs Chitwood and Nifong disclose that they have a financial relationship with Intuitive Surgical, Inc.
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The first robotic assistant with cardiac operations was Aesop (Computer Motion, Santa Barbara, CA), which allowed surgeons to control endoscopes without having to communicate through a human assistant [8]. In a 1998 report, Falk and Mohr [9] described robot-assisted minimally invasive or "solo" mitral valve repairs done in 8 patients. Thereafter, in several centers, times for cardiac arrest, cardiopulmonary bypass, postoperative ventilation, and intensive care unit stay fell progressively toward those of more conventional operations when Aesop was used with video-assistance [8, 10–12]. At the same time, overall hospital lengths of stay and costs were significantly reduced.
Over the last 5 years computerized surgical robotic systems have been developed. The da Vinci (Intuitive Surgical, Inc, Mountain View, CA) and Zeus (Computer Motion, Inc, Santa Barbara, CA) surgical robots have assisted the surgeon’s work using tele-manipulation through a master-slave (console-effector) activation principle with a three dimensional intracardiac camera. In 1998, Carpentier [13] and Mohr [14] serially performed the first mitral valve repairs using the da Vinci. Later, Lange’s group in Munich and colleagues [15] performed the first closed chest endoscopic mitral valve repair. In May 2000, under the first Food and Drug Administration (FDA) robotic investigational device protocol (G000023), our group repaired a mitral valve using the da Vinci surgical system [15]. Thirty seven additional robotic mitral repairs have been performed to determine device safety and efficacy. This report describes the largest series of robotic mitral repairs to date.
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Material and methods |
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Cardiopulmonary bypass was established at 26°C using femoral arterial inflow and kinetic venous drainage. Femoral vein to right atrial cannula (21–23 French) and right internal jugular vein cannula (17 French) was used in every patient. Cardiac access was through a fourth intercostal space mini-thoracotomy, developed from a 4–5 cm infra-mammary incision. A transthoracic aortic cross clamp (Scanlan International, Inc, Minneapolis, MN) and intermittent antegrade cold blood cardioplegia maintained cardiac arrest and myocardial protection. Mitral valves were exposed using a transthoracic atrial retractor (Cardiovations, Somerville, NJ) placed through a small left atriotomy. A left atrial sump sucker maintained a dry operative field, and intrathoracic carbon dioxide was insufflated continuously to displace intracardiac air. After the valve was inspected, ergonomic trajectory angles from the chest wall to valve were determined for insertion of left and right robotic arms. Most frequently the right trocar was placed in the fourth intercostal space posterior, lateral to the incision and parallel to the right superior pulmonary vein. Generally the left trocar was placed 6 cm cephalad and medial to the right trocar, insuring sufficient clearance between arms to avoid both external and internal arm conflicts. Optimal geometric positioning avoided obtuse converging angles between arms, which decreased left atrial wall tearing during instrument manipulations. The 3-D high-resolution endoscope was placed through the medial portion of the mini-thoracotomy and the remainder of the incision was used as a working port for the assistant. Needles were retrieved using a long magnetic device and suture remnants were vacuumed from the surgical field.
These procedures were performed from a surgeon console placed 10 feet from the operating table, while the patient-side assistant changed instruments and supplied and retrieved operative materials. The device provided motion scaling and tremor attenuation at the effector tips. Moreover, foot controls enabled ergonomic hand repositioning and dynamic camera manipulation. A variety of valve repairs were performed, and in every patient an annuloplasty band (Edwards Lifesciences, LLC, Irvine, CA) was deployed. Upon completion of the repair, robotic devices were removed from the operating table, and the left atrium was closed under direct vision to decrease operative times. Standard removal of air and weaning procedures were performed under transesophageal echocardiographic control. FDA and Institutional Review Board approved case report forms were collected on all patients preoperatively, intraoperatively, and postoperatively. In addition, intraoperative time points were collected by two resident surgeons and were cataloged in graphic spreadsheets. One month after discharge, all patients returned for follow-up physical examinations and transthoracic echocardiography. Two cardiologists with practices devoted completely to echocardiography read each study, and a biostatistician compared all data using both the independent samples t test (when its assumptions were justified) and a Wilcoxon test (otherwise). Data are shown as mean ± standard error of the mean with p values of less than 0.05 considered significant.
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Results |
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Comment |
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TopAbstractIntroductionMaterial and methodsResultsCommentAcknowledgmentsDiscussionReferences |
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The operative approach is similar to the videoscopic mitral valve procedure using a right mini-thoracotomy previously described [16, 17]. However, the skin incision has been reduced to 4 cm. Geometric placement of both robotic instrument arms and the transthoracic aortic cross clamp has been essential to avoid both external and intrathoracic instrument conflicts. Moreover, robot arm convergence at obtuse angles produces lateral atrial wall stress, tearing the atriotomy and destabilizing the retractor with loss of mitral valve exposure. Atrial tearing has been abolished with improved trocar placement and instrument convergence.
Data published earlier compared East Carolina University mitral valve repair procedures done by conventional approaches with videoscopic procedures done using either manually or robotically directed camera manipulation [9]. With the videoscopic mitral operations, both the combination of the Aesop 3000 robot (Computer Motion, Inc, Santa Barbara, CA) and greater operative experience enabled shorter operative times, fewer blood transfusions, and improved recovery times. Valve replacements were performed in 30% of patients. The progressive improvement in operative times in the current da Vinci series (Intuitive Surgical, Inc) compared favorably with the earlier videoscopic series. Similar reparative procedures were performed in the current study as in the videoscopic series, and these included quadrangular resections with and without sliding plasties, chordal transfers and replacements, and Alfieri type edge-to-edge repairs. In contradistinction, valve replacements were not performed in this series as these patients were excluded from the FDA-approved clinical trials. Clearly, robotic mitral valve replacement has become our next area for development.
Surface echocardiography was performed on all patients 1 month after operation. In total, 34 patients (89.5%) had grade I or less mitral regurgitation and 4 patients (10.5%) had grade II regurgitation. Even trivial regurgitation was documented as grade I. Moreover, studies document that many healthy patients with grade I mitral regurgitation have no documented progression of pathology [18]. None of the patients with echocardiographic grade II regurgitation had symptoms or a murmur, and none of these patients have progressed to further intervention.
This article represents the largest experience with robotic mitral valve repairs reported. Many important time factors have improved as the number of patients enrolled in the trial increased. Complex mitral valve repairs are possible with the da Vinci (Intuitive Surgical, Inc), and results compare favorably to conventional techniques. In this series, all had posterior leaflet disease, except 1 very early patient who had anterior leaflet prolapse. This patient developed post-repair hemolysis and required a valve replacement. This led us to exclude patients with anterior leaflet pathology for the remainder of this study; however, these patients will be included in the next phase of robotic procedure development.
A number of coapting technologies are being developed and promise to facilitate robotic cardiac procedures. Alternative suture techniques and prosthesis attachment devices have the potential of reducing operative times significantly. Our previous studies have demonstrated a 40-minute operative improvement when polypropylene welding (Axya Medical, Inc, Beverly, MA) was substituted for suture tying in experimental mitral valve replacements [19]. Beating heart valve repairs are being developed and eventually may obviate the need for cardiopulmonary bypass. Advancements in on-line 3-D echocardiography, as well as surgical navigation systems, will enable true totally endoscopic robotic cardiac operations. These studies suggest that performing complex mitral repairs is not only possible through robotic telemanipulation, but also safe and efficacious. Moreover, the flexibility of current devices enables operating in tiny spaces with extreme accuracy and foreshadows newer devices with greater facility and smaller effector instruments. Recently, a robotic training curriculum has been established, and our early experience suggests rapid adaptation to and subsequent adoption of this new technology by experienced general, urologic, gynecologic, and cardiac surgeons [20]. Comprehensive training should facilitate skill development in this field. Hopefully, this report and these early efforts will stimulate surgeons to adopt this and other evolving technologies in cardiothoracic surgery with the continual goal of providing better, less invasive care for our patients.
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Discussion |
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I will start with several comments. Parenthetically, I should add that I am not a paid consultant for Intuitive Surgical, and I have no equity stake in the company. First, on a minor technical note, for the benefit of those who might view complete reliance on antegrade cardioplegia delivery as unappealing, retrograde cardioplegia is not difficult to do through the same 4-cm incision.
If a comparison to nonrobotic procedures is a goal of this presentation, then "total robot time" perhaps has less relevance than a universal element like cross-clamp time. With cross-clamp time exceeding 2 hours, even in the most recent cohort, this is clearly a more time-consuming method than conventional valve repair. Certainly further improvement can be expected, and this has been our experience and the experience of other surgeons in the trial.
I readily agree with the authors that knot-tying may be a technical element relatively resistant to major improvement. This was mentioned in the manuscript, though not in the presentation. In my hands, it takes about 90 seconds to place five throws in one knot using da Vinci. I timed myself in several old videos of other operations for comparison, and found that it takes me about 8 seconds to do the same thing by hand. This is a big difference, and it may be that knot-tying is an area where a new paradigm is needed.
The results reported for length of stay are impressive; results for ICU and ventilatory time are perhaps only suggestive and less impressive. I happen to think this will prove to be one of the true benefits of robotic valve repair. However, putting on my contrarian hat for a moment, I think it is important to caution that these variables are very strongly influenced by surgeon and staff behaviors that may have little to do with the procedure, and have a lot to do with the enthusiasm of the surgeon for his new procedure.
There are certain to be others who wish to comment that the da Vinci system offers nothing not already available with other robotic systems. I know this in part because my patients are a cab ride away from several places that claim to have invented robotic surgery in various forms. It is my firm personal opinion that the three-dimensional optics and the instrument-tip dexterity of the da Vinci system are genuine leaps forward, and for the first time offer the promise of truly less invasive procedures that are safe and predictable.
As far as the available alternatives are concerned, I have seen nothing emerge to change my opinion that ministernotomies and minithoracotomies for valve surgery, including previous procedures called robotic, are all a lot like operating with knitting needles on the last potato chip at the bottom of a Pringle’s can.
Finally, three questions for the authors. First, it is mentioned in the manuscript that 7 of 38 procedures employed techniques classically associated with correction of anterior leaflet pathology. Were these done because significant anterior leaflet pathology was missed in the pre-repair assessment, or were they done to salvage a repair addressing typical posterior leaflet pathology?
Second, it is my impression that a 10% incidence of 2+ MR at one month is higher than expected. How would you say this figure compares to your own results, or to the results of others, with nonrobotic repair?
Finally, I assume you will agree with me that the ultimate goal is valve repair with a closed chest, similar to what Dr. Argenziano and my other colleagues at Columbia have achieved with ASD repair in a series now totaling 10 patients. What do you think we need to see before taking this step with mitral valve repair? Are the impediments device-related, such as might be overcome with an assistant arm or other attachments to the machine, or are they predominantly what I would call accessory-related, something that might be overcome with advances in suture welding, instruments, retractors, or other similar items?
DR NIFONG: First of all, I would like to thank Dr Smith for discussing our paper and also to congratulate his team with Mike Argenziano, Mehmet Oz, and Eric Rose at Columbia. As you know, they performed the first endoscopic coronary anastomosis just last week, as well as certainly leading in the atrial septal defect repair trials. So I would like to congratulate them with that work.
First of all, let me address the three questions. First, as mentioned in the manuscript, 7 of these 38 patients have had repairs addressing the anterior leaflet, and, yes, we were aware of those necessary repairs preoperatively. Actually the first 20 patients were part of a phase I feasibility trial that our center was involved with as a single institutional IDE. In that trial, we did not exclude patients with anterior leaflet pathology. However, what we learned from that trial was that dealing with patients with anterior leaflet pathology was more of a challenge than the more straightforward types of procedures that you have seen with posterior leaflet prolapse. For those reasons, when we wrote the multicenter trial, we excluded patients with anterior leaflet pathology until we gain more experience with the system and also have better technologies coming along.
Second, we recognize that these grade II mitral regurgitation patients are not ideal. This is higher than our conventional type of mitral valve repair or mitral valve procedures, which is all performed through the right chest videoscopically. However, we also recognize that with current echocardiographic probes and so forth, many of these leaks are detected at a higher rate than previously. We are searching aggressively to make sure that we have no problems related to mitral regurgitation after repair.
Also in addressing some of the new technology issues, certainly as many of you walk through the exhibits today and over the course of the first of the week, you will see a lot of new technology coming along. Certainly an assisting arm, which I think is being developed by different companies, will be of benefit. As many of you may be aware now, we simply do not have the ability to assist one’s self while operating, and this will certainly help.
Centainly knot tying is a very formidable consideration, as Dr Smith mentioned, and we are also evaluating ways to actually obviate the need for knot tying with new technology.
So with that, I would like to close. Thank you.
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= group 1; 
= group 2. (Band = time for placement of annuloplasty band; Bypass = cardiopulmonary bypass time; CC = aortic cross-clamp time; LRT = leaflet repair time; TOT = total operative time; TRT = total robot time.)
