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J Thorac Cardiovasc Surg 1997;114:434-439
© 1997 Mosby, Inc.

SURGERY FOR ACQUIRED HEART DISEASE

MINIMALLY INVASIVE CORONARY ARTERY BYPASS GRAFTING VERSUS CORONARY ANGIOPLASTY FOR ISOLATED TYPE C STENOSIS OF THE LEFT ANTERIOR DESCENDING ARTERY

Received for publication Dec. 18, 1996; revisions requested Jan. 22, 1997; revisions received June 2, 1997; accepted for publication June 2, 1997. Address for reprints: Piet W Boonstra, MD, PhD, Thorax Center, University Hospital Groningen, Hanzeplein 1, PO Box 30.001, 9700 RB Groningen, The Netherlands.

Abstract

Background: Isolated stenosis of the left anterior descending coronary artery can be treated with medication, percutaneous transluminal coronary angioplasty, or coronary artery bypass grafting. Recently a new treatment has been developed, which is called minimally invasive direct coronary artery bypass grafting. This new treatment is a modification of the conventional bypass operation and is performed through a small anterolateral thoracotomy without cardiopulmonary bypass. Methods: To compare minimally invasive bypass with angioplasty, we evaluated in-hospital results and 1-year follow-up in 181 consecutive patients with isolated type C stenosis of the left anterior descending coronary artery between January 1995 and July 1996. Of these patients, 71 underwent minimally invasive bypass and 110 angioplasty. Preoperative characteristics were not significantly different between the two groups. Results: In-hospital death, periprocedural myocardial infarction, emergency reoperation by means of conventional coronary bypass grafting, useof an intraaortic balloon pump, and cerebrovascular accidents were not significantly different between the two groups. At 1-year follow-up, survivial was not significantly different in the two groups (minimally invasive bypass 95.7% ± 0.2% vs angioplasty 95.3% ± 0.2%p = 0.89), whereas freedom from repeated revascularization was significantly more common in the group undergoing minimally invasive bypass (bypass 96.9% ± 0.2% vs angioplasty 67.6% ± 0.5%;p < 0.001). This study shows that the need for repeated revascularization, and therefore the use of health care resources, is significantly less with minimally invasive bypass than with angioplasty in patients with isolated type C stenosis of the left anterior descending coronary artery.

Isolated stenosis of the left anterior descending coronary artery (LAD) is associated with a poor prognosis. ¹ Both percutaneous transluminal coronary angioplasty (PTCA) ² and coronary artery bypass grafting (CABG) with the use of the left internal thoracic artery (LITA) ^3,4 are more effective than medical treatment in relieving symptoms and improving survival.

PTCA is considered the method of choice for treatment of isolated stenosis of the LAD, because of the low impact on the patient, low cost, and good early results. However, the results of PTCA for type C lesions are poorer than for type A and B lesions. ⁵

Recently a new surgical method for treatment has been developed for the treatment of stenosis of the LAD, which is called minimally invasive direct coronary artery bypass (MICABG). MICABG is a radical modification of the conventional CABG and is performed through a small anterolateral thoracotomy without cardiopulmonary bypass. ^6-9 MICABG aims at maintaining the advantages of conventional CABG in terms of survival and freedom from cardiac events, ^4,5,10,11 while avoiding its disadvantages, in particular, the midline sternotomy and the use of cardiopulmonary bypass.

Because MICABG is a new technique, its effectiveness has not been compared yet with PTCA in the treatment of isolated stenosis of the LAD. This study was designed to compare MICABG with PTCA in a group of consecutive patients with isolated type C stenosis of the LAD, by evaluating in-hospital results and 1-year follow-up.

Patients and methods

Study design.
To compare MICABG with PTCA, we evaluated in-hospital results and 1-year clinical follow-up in 181 consecutive patients with isolated type C stenosis of the LAD who underwent either MICABG or PTCA in the University Hospital of Groningen between January 1995 and July 1996. Because we considered the absence of recurrent myocardial ischemia to be a sign of successful revascularization in symptomatic patients with one-vessel disease, an angiographic follow-up study was obtained only in patients with recurrent chest pain and with abnormal exercise test results. Clinical data were collected in a customized database used for patient management. Follow-up was completed on the basis of telephone interviews and was closed on January 1, 1997.

Patients.
From January 1995 onward, 181 consecutive patients with angina pectoris, documented myocardial ischemia, and isolated type C stenosis ⁵ of the LAD were included in the study. A panel of two cardiologists and two cardiac surgeons gave general consensus on the feasibility of both MICABG and PTCA. The two treatments were then presented to the patients, who were informed of MICABG as an alternative treatment to PTCA, which was presented as the standard treatment. The final choice of treatment was left to the patient, who gave informed consent. The study was approved by the Institutional Review Board of the University Hospital of Groningen.

Of the 181 consecutive patients, 71 patients underwent MICABG and 110 underwent PTCA. All MICABG procedures were primary operations and all PTCA procedures were performed on de novo lesions. All operations were elective. Patients with "rescue PTCA" or with acute or evolving myocardial infarction were excluded from the study. Patients with any associated cardiac disease were also excluded from the study. The two treatment groups did not differ significantly with regard to preoperative characteristics (Table I).

A specially developed wound spreader (IMA Retractor, Cardio Thoracic Systems, Inc., Cupertino, Calif.) was secured in place. The particular shape of the spreader's arms created a visual tunnel toward the LITA through the small chest opening, thus facilitating the harvesting of the LITA. After the LITA had been harvested, the wound spreader was replaced by another spreader (Access Platform, Cardio Thoracic Systems) carrying a coronary artery stabilizer(Stabilizer, Cardio Thoracic Systems). The coronary artery stabilizer has been designed to immobilize the segment of the LAD including the site of the anastomosis. Immobilization of the LAD facilitates the performance of the anastomosis. Then heparin was given (100 IU/kg) and the thoracic pedicle was divided. The LAD was surrounded by two looping 5-0 polypropylene sutures, proximal and distal to the chosen site for the anastomosis. The LAD was opened longitudinally, the two looping sutures were pulled up to provide a bloodless operative field, and the LITA-LAD anastomosis was performed with a running 7-0 polypropylene suture. To remove excess blood from the anastomotic site, we used a blower device in the first 20 patients. After that we preferred to use irrigation with warm saline solution during the anastomosis (37° C). Protamine was not given at the end of the procedure. The small thoracotomy wound was closed in layers and one pleural drain was left in place. To reduce the time of ventilatory support, we used a protocol of fast weaning in all patients.

PTCA.
PTCA was performed through the right or left femoral access route or through the left or right radial artery. Guiding catheters in sizes 8F and 6F were used. The coronary arteries were cannulated with 0.014-inch guide wires, and matched-size monorail-type balloon catheters were used to dilate the lesions. PTCA was considered successful if the stenosis was reduced to less than 50%, as judged by visual estimation of the post-PTCA angiogram, and if ischemia and/or chest pain and/or flow obstruction were absent. ⁵ Coronary stents were implanted either as a bail-out procedure or for treatment of a suboptimal balloon angioplasty result.

Follow-up.
The design of the study required only clinical follow-up. To complete the data collection, we contacted the patients' attending cardiologists, who were responsible for routine follow-up. Four patients were lost to follow-up. A second angiogram was performed only in patients with recurrent chest pain and with abnormal exercise test results. For patients in the PTCA group who had a symptomatic restenosis, a second PTCA was recommended and conventional CABG was suggested as an alternative. For patients in the MICABG group who needed repeated revascularization, both PTCA and conventional ventional CABG were proposed. In both groups the final choice of treatment was left to the patient.

Statistical analysis.
All data were processed with the use of the SPSS statistical package (SPSS, Inc., Chicago, Ill.). All continuous variables are expressed as mean ± standard deviation.

All tests of significance were two-tailed: ² and Fisher's exact test for discrete variables and analysis of variance and Mann-Whitney test for continuous variables.

The primary end points were in-hospital procedure-related cardiac death and in-hospital myocardial infarction. Secondary end points were death related to cardiac disease at follow-up and repeated revascularization (either PTCA or conventional CABG) for symptomatic angina pectoris at follow-up.

Standard clinical, electrocardiographic, and laboratory criteria were used to identify the occurrence of myocardial infarction. Repeated revascularization was defined as the need for a PTCA or conventional CABG of the LAD. The outcomes of MICABG and PTCA were compared according to the intention-to-treat principle. The rates of in-hospital complications were compared only among patients who actually received the assigned treatment. Kaplan-Meier analysis was used to estimate the cumulative rate of survival (including in-hospital death) and repeated revascularization. ¹² Survival and freedom from repeated revascularization were expressed as cumulative data ± standard error of the mean (95% confidence intervals). Kaplan-Meier curves of survival and freedom from repeated revascularization were compared by means of the log-rank test. ¹³

Results

PTCA group.
PTCA was successful in 94 of 110 patients (stents were used in 15 of these patients). PTCA was unsuccessful in the remaining 16 patients. Among them, four patients underwent rescue (emergency) CABG and four patients underwent elective CABG during the hospitalization.

We recorded three in-hospital deaths. One patient died during PTCA, one patient died of acute renal insufficiency caused by the contrast medium, and one died of ventricular fibrillation during the hospital stay. Four patients had an in-hospital myocardial infarction. Among them, one patient required treatment with an intraaortic balloon pump. One patient had a cerebrovascular accident (transient ischemic attack). Six patients refused further treatment after the unsuccessful PTCA and were treated medically. Mean hospital stay was 4.4 ± 5.2 days.

MICABG group.
MICABG was successful in 69 of 71 patients. MICABG was converted to conventional CABG via a midline sternotomy in the remaining two patients, and the anastomosis on the LAD was made during cardioplegic arrest. The conversion to a midline sternotomy was due to difficulties in finding the LAD. A third patient underwent emergency CABG via a midline sternotomy on postoperative day 1 after sudden electrocardiographic changes that appeared after extubation. This patient received an extra vein graft to the LAD.

We recorded one in-hospital death. The patient in question was discharged from our unit on postoperative day 4 after an uneventful postoperative course and was transferred to the internal medicine department for continuation of immunosuppressive treatment because of a previous liver transplantation. He died of acute liver failure 45 days after MICABG. Four patients had a perioperative myocardial infarction: they all were restudied by means of angiography on postoperative day 1, and in all of them the LITA-LAD anastomosis was patent. Two of the four required treatment with an intraaortic balloon pump. All in-hospital cardiac complications in the MICABG group occurred among the first 14 patients. In particular, we recorded perioperative myocardial infarctions only in the early group of patients treated by MICABG, when a blower device was used to achieve a bloodless operative field. We have therefore related the occurrence of perioperative infarction to air embolism in these patients, in the absence of an angiographically demonstrated malfunction of the LITA-LAD anastomosis. This fact led us to discontinue the use of a blower device in favor of irrigation with warm saline solution (37° C). One patient had a cerebrovascular accident (transient ischemic attack).

Mean operative time was 91.1 ± 28.0 minutes (range 60 to 230 minutes). Mean time of coronary occlusion was 10.7 ± 3.5 minutes (range 5 to 23 minutes). Mean hospital stay was 4.4 ± 1.8 days (range 3 to 11 days). No significant differences in in-hospital results were identified between the two treatment groups (Table II).

View larger version (11K): [in this window] [in a new window]   Fig. 1. Survival after PTCA or MICABG.

View larger version (13K): [in this window] [in a new window]   Fig. 2. Freedom from repeated revascularization after PTCA or MICABG.

Discussion

This study shows that the need for repeated revascularization and therefore the use of health care resources is significantly lower after MICABG than after PTCA in patients with isolated type C stenosis of the LAD. This study also shows that 1-year survival is not significantly different between MICABG and PTCA. Surprisingly, the in-hospital results are not significantly different between the two groups, and these results should even be evaluated in the light of a technique-related bias: PTCA is a standard technique with established results, ⁵ whereas MICABG has just passed its pioneering era. Therefore the learning curve may have masked a potential difference in in-hospital results in favor of MICABG. This observation is supported by the fact that all cardiac complications in the MICABG group occurred among the first 14 patients. Later on, the cardiac morbidity and mortality of MICABG dropped to zero and no patient required repeated revascularization.

The question whether PTCA or surgical treatment is the best option for patients with isolated stenosis of the LAD remains controversial, although some trials have shown that conventional CABG (via a midline sternotomy and with cardiopulmonary bypass) may yield better midterm and long-term results than PTCA. ^14-20 In fact, in these trials the risk of cardiac death or myocardial infarction at follow-up in patients with single-vessel disease was lower for conventional CABG than for PTCA. ^14-20 In particular, PTCA of the proximal LAD has been associated with rates of restenosis that range from 30% up to 50%. ^15,21-23 The results of PTCA of the LAD have been even poorer for type C stenosis. ⁵ On the other hand, conventional CABG, although having better midterm and long-term results, generally causes a longer hospital stay, higher morbidity, and higher initial cost of medical care than PTCA. The cost of conventional CABG and PTCA is primarily dependent on the occurrence of postprocedural complications, including the recurrence of myocardial ischemia at follow-up. ^16-18,23 The reduced use of disposable materials and the shorter hospital stay render the initial cost of MICABG lower than that of conventional CABG. Later on, the greater need for repeated revascularization at follow-up in the PTCA group causes a further increase in use of health care resources compared with MICABG. These two observations can favor MICABG as an alternative treatment to PTCA for patients with isolated type C stenosis of the LAD.

Two possible objections to this study can be raised. The first objection is that we did not use stents as a primary treatment in patients undergoing PTCA, because at the beginning of the study (January 1995) primary stent implantation was not considered a standard procedure. Recent studies ^24,25 have shown that primary stent implantation provides better results and fewer adverse events at follow-up than does conventional PTCA. Still, the need for repeated revascularization in patients who have had PTCA with primary stent implantation remains higher than that reported in this study in patients subjected to MICABG. The second objection is that we did not perform a routine angiographic follow-up study. The reason for this choice is that we considered the absence of recurrent myocardial ischemia to be a sign of successful revascularization in symptomatic patients with one-vessel disease. Future clinical and angiographic prospective studies comparing primary stent implantation and MICABG may further clarify this issue.

In conclusion, MICABG is more effective than PTCA for patients with isolated type C stenosis of the LAD at 1-year follow-up. The advantages of MICABG in terms of in-hospital results and reduced initial cost may overcome the initial disadvantages of the conventional CABG via a midline sternotomy, while ensuring the best results of surgical revascularization in these patients. The potential advantages of the LITA graft to the LAD can further increase this difference in favor of the MICABG in midterm and long-term follow-up.

Acknowledgments

We thank H. Los, MA, for her support in preparing the manuscript. We also thank C. T. Mellema, L. M. de Noo, M. Bergsma, and R. Mollema for data collection.

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This Article Abstract 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 Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Massimo A. Mariani Piet W. Boonstra Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Mariani, M. A. Articles by Crijns, H. J. G. M. Search for Related Content PubMed PubMed Citation Articles by Mariani, M. A. Articles by Crijns, H. J. G. M.