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Ann Thorac Surg 2006;81:1666-1675
© 2006 The Society of Thoracic Surgeons
a Milstein Hospital, Columbia University, New York, New York
b Henrico Doctors' Hospital, Richmond, Virginia
c Leopold-Franzen-Universitat Innsbruck, Klinische Abteilung fur Herzchirurgie, Innsbruck, Austria
d Alliance Hospital, Odessa, Texas
e St. Joseph Hospital of Atlanta, Atlanta, Georgia
f Saint Agnes Medical Center, Fresno, California
g Department of Cardiothoracic Surgery, Lenox Hill Hospital, New York, New York
h Sacred Heart Medical Center, Spokane, Washington
i Intuitive Surgical Inc, Sunnyvale, California
Accepted for publication November 3, 2005.
* Address correspondence to Dr Argenziano, New York Presbyterian Hospital, Columbia Presbyterian Medical Center, Department of Cardiothoracic Surgery, 177 Fort Washington Ave, Milstein Hospital, Suite 7-435, New York, NY 10032 (Email: ma66{at}columbia.edu).
Presented at the Forty-first Annual Meeting of The Society of Thoracic Surgeons, Tampa, FL, Jan 24–26, 2005.
| Dr Argenziano discloses that he has a financial relationship with Intuitive Surgical.
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Abstract |
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METHODS: Patients requiring left anterior descending (LAD) coronary artery revascularization were eligible. The procedure was performed with femoro-femoral cardiopulmonary bypass (CPB), endoaortic balloon occlusion, and thoracoscopy. All aspects of the procedure were performed with the robotic system, from internal mammary artery harvest to coronary anastomosis.
RESULTS: Ninety-eight patients requiring single-vessel LAD revascularization were enrolled at 12 centers. Thirteen patients (13%) were excluded intraoperatively (eg, failed femoral cannulation, inadequate working space). In 85 patients (69 men, age 58 ± 10 years) who underwent TECAB, CPB time was 117 ± 44 minutes, cross-clamp time was 71 ± 26 minutes, and hospital length of stay was 5.1 ± 3.4 days. There were five (6%) conversions to open techniques. There were no deaths or strokes, one early reintervention, and one myocardial infarction (1.5%). Three-month angiography was performed in 76 patients, revealing significant anastomotic stenoses (> 50%) or occlusions in 6 patients. Overall freedom from reintervention or angiographic failure was 91%.
CONCLUSIONS: Robotic TECAB was accomplished with no mortality, low morbidity, and angiographic patency and reintervention rates comparable with published data. Although the use of CPB was a limitation of the technique, this experience represents a step toward more advanced procedures, such as multivessel or off-pump TECAB.
Computer (robotic) enhancement has emerged as a potential facilitator of minimally invasive surgical procedures. Initial applications of this technology were limited to providing enhanced (including voice-activated) endoscopic camera control [1] during minimal access procedures. A more advanced iteration of this technology is represented by the da Vinci surgical system (Intuitive Surgical, Sunnyvale, CA), a computerized telemicromanipulator that allows a surgeon to control two or three "wristed" endoscopic instruments from an operating console, while viewing the operative field through a three-dimensional endoscopic camera. Two Food and Drug Administration (FDA)-sanctioned Investigational Device Exemption (IDE) trials have validated the safety and efficacy of this device for mitral valve repair [2] and atrial septal defect closure [3].
Loulmet and colleagues [4] and Falk and colleagues [5] have described the technique of totally endoscopic coronary artery bypass (TECAB), in which the da Vinci robotic surgical system is used to perform an entire coronary bypass procedure (including coronary anastomosis) in a closed chest environment. Notwithstanding the feasibility demonstrated by these and other pioneering investigators [6–8], the TECAB operation has not been subjected to evaluation in a clinical trial. This report describes the results of a multicenter, FDA-sanctioned IDE trial investigating the safety and efficacy of arrested-heart, single-vessel TECAB.
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Material and Methods |
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Training Protocol
All investigators participating in the trial were required to undergo a stepwise training program before enrolling patients in the trial. By requiring the demonstration of proficiency at each training level before allowing continuation to the next level, the minimum level of technical proficiency was standardized. The stages of the TECAB training requirements were the following: stage 1 – basic da Vinci surgical system training; stage 2 – robotically assisted IMA mobilization; stage 3 – minimally invasive cardiopulmonary bypass (CPB) experience: stage 4 – TECAB specific training; stage 5 –TECAB training cases.
Inclusion and Exclusion Criteria
Patients were considered eligible for enrollment in the trial if deemed appropriate candidates for nonemergent, first time single-vessel left internal mammary artery (LIMA) to left internal descending (LAD) myocardial revascularization. Complete inclusion and exclusion criteria are listed in Tables 1 and 2.
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These and other clinical endpoints, including intraoperative conversion rates and other adverse events, were compared with a historical cohort of patients who underwent conventional single-vessel, arrested heart coronary artery bypass grafting (CABG) surgery. This comparison was based on data obtained from a specific query of the Society of Thoracic Surgeons (STS) National Database for the years 2000–2002 [STS Adult Cardiac National Database; Core Data Elements Summary, Custom Query version 2.41, Adult Coronary Artery Bypass Procedures 2000–2002].
Follow-up and Data Collection
Preoperative assessment
Patients referred for coronary artery bypass surgery had a preoperative visit consisting of a medical history, physical examination, and diagnostic tests, including but not limited to coronary angiography, transthoracic echocardiography, stress electrocardiogram (ECG), resting 12-lead ECG and chest x-ray. Based on this information and the established inclusion-exclusion criteria, the investigator determined the need for surgical revascularization and the appropriateness of the patient for robotically assisted TECAB.
Intraoperative and intensive care unit (ICU) assessment
For each case, intraoperative times were determined based on perfusion, anesthesia, and operative records or were explicitly recorded during the operation. The details of the surgical procedure, including revascularization scheme, steps of the surgical procedure that were completed robotically, conversion to alternate techniques, time to conversion and reason for conversion, were documented in the operative case report forms.
Immediate postoperative assessment
Immediate postsurgical clinical information was recorded per standard hospital practice and as indicated by the investigator as a part of routine postoperative cardiac care. A postoperative resting 12-lead ECG, chest x-ray, and cardiac enzymes were obtained per standard of care at that institution.
Follow-up postoperative assessment
Patients had a follow-up visit approximately 3 months postoperatively, at which point angiograms were obtained. Supplemental postoperative studies, such as a stress ECG, transthoracic echo, resting 12-lead ECG, and physical exam were obtained in order to complete the clinical assessment of the patient.
Core Laboratory Review of Angiographic Studies
A primary core laboratory at the Hoag Heart Institute reviewed all preoperative and postoperative angiographic studies. The core laboratory reviewer was masked to the individual institution's assessment of graft patency.
Data Collection, Entry, and Verification
Clinical information for patients enrolled in the study was collected at all participating institutions and verified against the patients' medical records by qualified personnel designated by the study sponsor. All applicable information from the medical charts was recorded onto standardized case report forms and entered into a database.
Statistical Methods
All continuous variables were analyzed using a nonparametric, Wilcoxon rank sum test for two group comparisons. Categorical data were analyzed using 
2 tests for association with or without continuity correction. In the case of small cell comparisons a Fisher's exact test was used. In all cases 2-tailed p values of less than 0.05 are considered significant. The binomial distribution was used for the assessment of binary outcomes (ie, patency) with Agresti's formula used for the computation of one-sided 95% confidence intervals. Conversion rate comparisons were made with those seen in a literature survey of published conversion rates based on similar cardiac operations of comparable complexity. Comparisons of the incidence of significant adverse events were made between da Vinci TECAB and coronary artery bypass as reported in a customized query from the STS National Database (2000–2002) for single-vessel arrested heart sternotomy CABG. For these comparisons, a normal approximation to the da Vinci arrested heart TECAB summary statistic was used. Generalized estimating equations were used for analyzing the learning curve effects associated with times to complete various tasks associated with CABGs. This method takes into consideration the underlying correlation structure of repeated measurements (ie, a given surgeon's case experience over time).
Data Safety Monitoring Board Review of Clinical Trial Safety
Data from the study were reviewed by a cardiac surgeon who was not an investigator in the study. All adverse events, including all conversions and reinterventions in this study were reviewed. The reviewer was blinded to the institution at which each case was performed and to the surgeon who performed each case.
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Results |
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Demographics
A total of 98 patients were enrolled in the trial (not including stage 5 training cases) at 12 centers (see Appendix). Of these, 13 were excluded intraoperatively and did not undergo TECAB. The reasons for these exclusions will be discussed in the next section. Demographics and baseline characteristics of the remaining cohort of 85 patients undergoing TECAB are summarized in Tables 4 and 5.
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Operative and ICU Data
In the 85 patients undergoing TECAB, total operative time was 353 ± 89 minutes (mean ± SD), with a range of 200 to 600 minutes. Notable subcomponents of this operative time included internal mammary artery harvest time (60 ± 24 minutes; range, 26–187 minutes), cardiopulmonary bypass time (117 ± 44 minutes; range, 41–254 minutes), aortic cross-clamp time (71 ± 26 minutes; range, 30–140 minutes), and coronary anastomosis time (28 ± 11 minutes; range, 14–82 minutes). Postoperative ventilation time was 14 ± 28 hours (range, 0–217 hours), ICU length of stay was 35 ± 37 hours (range, 4–288 hours), and hospital length of stay was 5.1 ± 3.4 days (range, 1.2–25.5 days). Twenty-six of 85 patients (31%) received blood products perioperatively.
Completeness of Follow-Up
Of the 85 patients undergoing TECAB, all were followed through to study completion. One patient underwent target vessel reintervention for graft occlusion. Three-month postoperative angiography was performed in 76 of the 85 patients (89%), echocardiography in 72 (85%), and stress testing in 58 (68%). A frame from a representative 3-month angiogram is shown in Figure 2.
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50%) in 4 others. Of these 6 patients, only one (who was symptomatic) underwent reintervention after the three-month angiogram. Thus, a total of 7 of 80 patients having TECAB had either target vessel reintervention or angiographic documentation of graft failure. Because 5 patients had neither a reintervention nor an angiogram, this corresponds to a freedom from graft failure or a reintervention rate of 68/75, or 91%.
Safety Endpoints
Major adverse cardiac events (MACE) were defined as all-cause mortality, myocardial infarction, or target vessel reintervention. There were no deaths from any cause in the cohort during the study period. There was one perioperative myocardial infarction, and 4 target vessel reinterventions (as described above), corresponding to 5 MACE events in 85 patients (5.9%). The incidence of these and other adverse events in the study group is listed in Table 6, along with corresponding incidences from a query of the STS database for similar patients undergoing single-vessel coronary bypass on the arrested heart by sternotomy in 2000–2002. The comparison indicates that our study cohort compared favorably with the STS database cohort. There were 5 groin infections, which did not result in major morbidity but were a TECAB-specific complication not usually associated with conventional approaches, which only infrequently utilize femoral cannulation. Finally, the transfusion rate of 31% was higher than expected, and may reflect the effects of longer cardiopulmonary bypass times in some patients.
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Comment |
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The technical dexterity and three-dimensional visualization afforded by robotic technology has also been applied to CABG. In 1999, Loulmet and colleagues reported the first use of the da Vinci system for coronary bypass surgery [4]. According to this pioneering report, the robotic system was used to harvest internal mammary artery grafts in four patients, and to complete the remainder of the CABG operation in two of these patients by a totally endoscopic approach (TECAB). A year later, Falk and colleagues [5] reported a much larger experience of robotically assisted CABG surgery, which included 22 patients undergoing TECAB. Subsequent reports of similar experiences by Kappert and colleagues [11] and Dogan and colleagues [8] have supported the feasibility of robotically assisted TECAB. Notwithstanding the achievements of these and other pioneering surgeons, early outcome data were available only in the form of anecdotal single-center reports, and selection criteria for TECAB, as well as technical details of the procedures (on-pump versus off-pump, arrested versus beating heart, target vessel and conduit selection, etc), were not standardized. Therefore, prior to granting approval of TECAB as an indication for use of the da Vinci system, the Food and Drug Administration required the evaluation of this new operation in a controlled clinical safety and efficacy trial.
The present study demonstrated that TECAB can be performed with acceptable safety. In 85 patients, there were no deaths, and only one postoperative myocardial infarction. Other adverse events, such as target vessel reintervention, renal failure, and reoperation for bleeding occurred with equal or lesser frequency than in patients undergoing similar coronary bypass procedures by conventional approaches.
Efficacy in this study was defined as freedom from the composite endpoint of target vessel reintervention or angiographic graft failure after three months. By this definition, after excluding 5 intraoperative conversions and 5 patients without angiographic follow-up data, 68 of 75 evaluable patients, or 91%, had effective procedures. Three of the intraoperative conversions were due to mammary artery damage or anastomotic bleeding, while two were from poor graft flow as assessed by intraoperative angiography.
These results compare reasonably with available data from studies of coronary bypass surgery by minimally invasive and conventional approaches. In a study by Diegeler and colleagues [12], in which a cohort of 271 patients underwent LIMA-LAD bypass by a minithoracotomy, beating heart approach (MIDCAB), angiography revealed a graft patency rate of 88.2% at hospital discharge and of 91.5% at 6 months. In a similar study by Mack and colleagues [13], the graft patency rate after MIDCAB was 91%. Jatene and colleagues [14] reported the angiographic follow-up of 120 patients who had off-pump coronary artery bypass (OPCAB) by sternotomy or minithoracotomy (MIDCAB). In cases performed without a cardiac stabilization device, early (predischarge) graft patency was only 79%; when a stabilizer was used, the patency rate improved to 90%. In a substudy of the International Multicenter Aprotinin Graft Experience (IMAGE) trial [15], in which all patients underwent on-pump CABG by sternotomy, Berger and colleagues found that early angiographic LIMA-LAD patency was 90.9%. Finally, in a recent randomized study by Khan and colleagues [16] published in the New England Journal of Medicine in 2004, off-pump CABG resulted in an observed 3-month angiographic patency rate of 92% for IMA grafts and for grafts to the left anterior descending artery. Although these grafts in patients undergoing conventional, on-pump CABG had a patency rate of 100%, the authors concede that "our rate ... in the on-pump group is at the high end of the reported range," citing the paper by Nathoe and colleagues [17], published a year earlier in the same journal, in which the angiographic graft patency rate after on-pump CABG was 93%.
There were five conversions in the trial, corresponding to a rate of 6%. These were cases in which intraoperative difficulties prompted the choice of an alternative approach in order to complete the coronary bypass operation. All converted patients had three-month angiography documenting graft patency, and none underwent reintervention of the target vessel postoperatively. This conversion rate compares favorably with studies of other novel minimal access operations, such as MIDCAB [18, 19], minimally invasive aortic valve replacement [20], and thoracoscopic IMA harvest [21], in which conversion rates ranged from 3.9% to 8.3%.
A unique component of our trial was the mandatory, stepwise training program that required prospective investigators to achieve minimum standards of proficiency in specific tasks in order to "graduate" to the full TECAB operation. The enforcement of this program achieved several goals. First, surgeons unable or unwilling to master basic but important components of the TECAB operation, such as robotic IMA harvesting and peripheral perfusion with endoaortic balloon clamping, never entered the trial, minimizing technical failures. Second, the learning curves for certain tasks were established prior to trial entry; as an example, our analysis confirms that IMA harvest times for surgeons in the trial had reached a plateau before the first TECAB was ever performed. Finally, in the face of the recent FDA approval of robotically assisted CABG (which was attained on the basis of data from this study), our stepwise training plan will serve as a prototype in the development of a larger scale training program.
Our study has its limitations. Patients were not randomized to different minimally invasive techniques, such as OPCAB and MIDCAB, so that comparative evaluation of TECAB safety and efficacy data is dependent on intrinsically imperfect historical data. Furthermore, although TECAB is often proposed as a less invasive alternative to OPCAB and MIDCAB, two "off-pump" procedures, safety concerns led to the decision that the trial would study TECAB in the "on-pump," arrested heart setting. This fact somewhat limits the extrapolation of our results to other "more desirable" descendants of arrested heart single-vessel TECAB, such as beating heart TECAB and multivessel TECAB. This is unfortunate, since it is difficult to support the concept of an "on-pump" operation for single-vessel coronary disease as anything more than a steppingstone to beating heart or multivessel TECAB. Finally, although complication rates in our trial compare favorably with those reported to the STS database for patients undergoing single-vessel CABG, we must be cautious in deriving strong conclusions from this comparison, as the two patient cohorts were not prospectively randomized or retrospectively matched. Notwithstanding these limitations, the experience obtained in this trial is certain to further the development of other TECAB variants. Early proof of this is the fact that several of our trial investigators have already accumulated a significant experience in multivessel and beating heart TECAB since the trial's end.
In conclusion, our multicenter, prospective evaluation of robotically assisted, totally endoscopic coronary bypass surgery demonstrated that this operation can be performed with acceptable safety and efficacy by surgeons who undertake a structured and rigorous training program. Although TECAB will make its greatest impact when applied in an off-pump setting and/or for multivessel disease, this trial confirms the feasibility of coronary bypass surgery by robotic means and suggests a continued role for robotic technology in the pursuit of ideal procedures that will deliver maximal efficacy and safety in the treatment of cardiovascular disease with minimal invasiveness.
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Appendix |
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Aalst, Belgium
Leopold Franzen Hospital
Innsbruck, Austria
Odessa Regional Hospital
Odessa, Texas
Henrico Doctors Hospital
Richmond, Virginia
Saint Agnes Medical Center
Fresno, California
Lenox Hill Hospital
New York, New York
Columbia University Medical Center
New York, New York
St. Joseph's Hospital of Atlanta
Atlanta, Georgia
Carilion Roanoke Memorial Hospital
Roanoke, Virginia
St. Lukes Medical Center
Milwaukee, Wisconsin
Sacred Heart Medical Center
Spokane, Washington
Hospital University of Pennsylvania
Philadelphia, Pennsylvania
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Discussion |
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DR ARGENZIANO: That is a very good question. There really is a two-part answer. The first question is do we think that a six-hour operation which requires cardiopulmonary bypass and femoral cannulation has a future for single vessel disease, and I think the answer is no, because in fact there are very few people who have had to do that after the trial. The stipulation was that we had to prove that this was safe in a more comfortable on-pump setting. There is no question that this is really a steppingstone in that the MIDCAB (minimally invasive direct coronary artery bypass) or the mini ThoraCAB, whatever you want to call it, the endo-ACAB, certainly achieves similar goals without the cardiopulmonary bypass.
With respect to your question about the success rate or the efficacy end point, again, if you ask any cardiac surgeon, well, what is your LIMA (left internal mammary artery) to LAD (left anterior descending) patency rate, they will say, oh, it is 100% or 99%. There was Mrs. Nussbaum. The problem is we don't know what mammary patency rates are, and if you look at the literature, if you look at every study, including the large aprotinin study, which looked at angiographic patency rates, and some of the MIDCAB trials and some of the OPCAB (off-pump coronary artery bypass) trials, any study that has ever looked at vein or mammary patency rates has found the patency rates, in reality, to be much less than people think. So do I think that 88% is a good success rate? I don't, but I suspect that if we took our patients in our practices and did routine three-month angiograms we might be surprised at what would be found.
DR SUDHIR P. SRIVASTAVA (Odessa, TX): I have a comment on your earlier question, and I think it is a very relevant question. Of course the trial, as Mike has pointed out, was really a springboard to get to the next stage, and I think since then the beating heart and da Vinci coronary revascularization is being done, and in fact in many centers those timings have really come down. We have done about 50 cases since July since the FDA (Food and Drug Administration) cleared the coronary anastomosis, and our single vessel timings are down to around two to two and a half hours, and these patients, many of them go home the next day, and we have 100% graft patency. So I think it was an evolutionary step for a later purpose.
DR ARGENZIANO: Sudair should be really congratulated. Dr Srivastava was one of the investigators in our study, and he and a few others have really kind of taken the lead that of course was established by our European colleagues, some of whom were in the trial, some of whom weren't, in moving to the next step, and of course, beating heart TECAB is being performed in Europe and at several centers here in the United States. And frankly, there are learning curves associated with all these procedures. Of the 12 centers that were involved, eight of the surgeons in the center did at least five cases, but there were some who did less. So obviously learning curve is important.
DR OMAR M. LATTOUF (Atlanta, GA): Dr. Argenziano, I have a couple of comments for you. Six patients in your group were converted out of the planned TECAB because of peripheral vascular disease. Did you perform femoral ultrasound in advance, preoperatively, for those patients and would you do that now based on your experience? The second point, you had a 10% stenosis or occlusion rate. Did you use a shunt in the LAD, or would you use a shunt in the LAD to keep that patent and give you a better chance of graft patency?
DR ARGENZIANO: With respect to the femoral cannulation, all patients did not receive ultrasounds but in fact there was a peripheral vascular exam involving pulses and Dopplers and history. As you know, patients with coronary disease do have some incidence of significant peripheral vascular disease of the iliofemoral system. There was no specific criterion for that, and I think that was something that we did learn. There was significant incidence of this. This is really a problem that doesn't need too much of a solution because, of course, the goal is to do this without cannulation.
You were talking about intracoronary shunts. We didn't because this was an arrested heart trial, and so it was cardioplegic arrest and it was a still heart. Certainly, for the surgeons that are performing beating heart TECAB, the shunt has been helpful, as it is in other forms of OPCAB.
DR INDERJIT S. GILL (Cleveland, OH): The angiograms that you had in the study, were they analyzed in a single core lab or were they done in individual hospitals?
DR ARGENZIANO: All angiograms were sent to a primary core laboratory which rendered an independent blinded assessment, but they were also evaluated by the individual cath labs in the member hospitals, and if there was a disagreement between the primary core lab and the institutional lab, then those studies were referred to a secondary core lab for adjudication.
DR GILL: And a second question. How many of these patients had hybrid diseases?
DR ARGENZIANO: Approximately 30% to 40% of the patients in the study were participants in some form of hybrid scheme.
DR DIMITRI NOVITZKY (Tampa, FL): I have concerns about the study because of such a long ischemic and bypass time. My first question, is it ethical to continue with the study? If you yourself will require coronary bypass surgery, which way would you prefer? For myself, I would choose a standard midline sternotomy. I know that we need to be innovative and introduce changes in surgical procedures. The driving force for the patient care should be the surgeon and not the industry. You should not allow yourself to be pushed and therefore compromise the patient outcome.
DR ARGENZIANO: Thank you for your comments. Your questions are all questions that run through our minds any time we engage in innovative work. Without question, from the first use of the cardiopulmonary bypass machine to what we are doing today, there is a certain amount of trepidation that is involved in the changing of a standard. However, without that sort of thinking, innovation certainly has no chance. But I would have to agree with you that from an ethical standpoint we were very careful. We had a data safety monitoring board, which was chaired by a very experienced, minimally invasive surgeon from Europe who was not involved in the trial, and every adverse event was reviewed, and there was specific criteria for halting the trial or modifying the numbers, and those were not achieved.
With respect to whether I would have this operation done, again, as I say, the healthy patient with a good ventricle certainly has a low risk of complications, but this trial was a steppingstone trial, and based on what we have learned, we have already moved ahead to the next step. So the answer to your question, if I had a single vessel that needed to be revascularized, I would not have trouble having a beating heart TECAB performed by a surgeon with experience in that area. But again, the trick is getting the experience.
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