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Ann Thorac Surg 2002;73:1849-1855
© 2002 The Society of Thoracic Surgeons
a Heart Center Hamburg, Albertinen-Krankenhaus, Departments of Department of Cardiac Surgery, Hamburg-Othmarschen, Germany
b Department of Cardiac Anesthesiology, Hamburg-Othmarschen, Germany
c Department of Cardiology, Hamburg-Othmarschen, Germany
d Center for Cardiology, Hamburg-Othmarschen, Germany
Accepted for publication February 6, 2002.
* Address reprint requests to Dr Riess, Heart Center Hamburg, Albertinen-Krankenhaus, Abteilung für Herzchirurgie, Suentelstrasse 11a, 22457 Hamburg, Germany
e-mail: friedrich-christian.riess{at}albertinen.de
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Abstract |
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Methods. Between January 1997 and January 2001, 57 consecutive patients (41 men and 16 women, aged 65.7 ± 7.9 years) with coronary artery disease (two-vessel, n = 34; three-vessel, n = 23) were treated with off-pump LIMA-to-LAD bypass combined with balloon angioplasty and stenting of the remaining significantly obstructed (> 50%) coronary vessels. Clinical follow-up data included a early postoperative and a 6-month control angiography and a patient interview in January 2001.
Results. All patients underwent LIMA-to-LAD bypass-grafting and balloon angioplasty in 72 coronary lesions without procedural-related complications. However, one early LIMA bypass occlusion was documented during coronary angiography. Postoperatively no deterioration of preexistent organ dysfunction was observed in any patient. The mean follow-up was 100.7 ± 37.9 weeks in 55 of 57 patients (97%). Control angiography 6 months after HyR (n = 34) revealed a patent LIMA bypass in 33 patients and 8 in-stent restenoses (> 50%) in the coronary arteries that were treated interventionally by re-PTCA (n = 6) or by conventional CABG (n = 1). In 1 patient medical treatment resulted in significant reduction of angina so no further intervention was considered necessary. After HyR 1 patient died 18 months later of an intracerebral hemorrhage. All other patients are alive and doing well.
Conclusions. Our results indicate that in selected patients with multivessel disease including left main stem stenosis HyR is an effective and secure procedure with excellent early and good midterm results. Especially elderly patients with severe concomitant diseases appear to benefit from this approach by avoiding CPB.
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Introduction |
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After inauguration of the off-pump LIMA-to-LAD bypass procedure into the clinical setting [5] the interest in this approach has increased continuously in the last years [6, 7]. The most interesting fact of this concept is that CPB with all its negative side effects can be avoided [5, 6]. Especially high-risk patients with severe concomitant diseases such as renal, pulmonary, and neurologic dysfunction and patients with calcification of the ascending aorta or other diseases appear to benefit from this new approach [8–10]. However, the concept of minimally invasive LIMA-to-LAD bypass using a small surgical access is limited to a relatively small number of patients with single-vessel disease and high degree of proximal LAD stenosis occlusion, which is not suitable for balloon angioplasty.
Therefore we investigated the combination of minimally invasive LIMA-to-LAD bypass with percutaneous transluminal angioplasty (PTCA), which appears to be an attractive alternative to conventional CABG with all its inherent disadvantages. Several authors have described their initial experience with this approach [8, 11–15]. However, mid- and long-term results using this new technique have not been reported until now. We present our experience with 57 patients with coronary multivessel disease having undergone HyR in the last 4 years.
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Material and methods |
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The clinical study was approved by the local institutional human research committee (date of approval 2 July 1996) and informed consent was obtained in all patients.
Anesthesia and surgical technique
A minimally invasive LIMA-to-LAD bypass was performed in all patients. Operative technique included an inversed L-shaped ministernotomy up to the left third intercostal space (ICS). LIMA was harvested up to the second ICS under direct vision using a special retractor (midCOAST; Aesculap, Tuttlingen, Germany). After pericardiotomy an intravenous bolus of heparin (150 IU/kg body weight) was administered. LAD was snared twice in the midlevel using silicon loops with a blunt needle. These vessel loops were used together with the midCOAST device for LAD occlusion and local stabilization [16]. After a test occlusion of 5 minutes followed by another 5 minutes of reperfusion the LAD was occluded again and anastomosis between LIMA and LAD was performed with a running 8-0 monophilic suture on the beating heart without the use of CPB. Anticoagulatory effect of heparin was partially (2/3) antagonized by protamine. Postoperative anticoagulatory management included unfractionated heparin as an intravenous (IV) infusion (100 to 200 IU/kg body weight), acetylsalicylic acid 500 mg IV 4 hrs after the end of surgery and 100 mg/day per os the following days.
Interventional procedures
After a median of 5 days postoperatively the patients were transferred to the department of cardiology or to the referring cardiologist. The femoral artery was punctured and a 7F or 8F sheath was used for vessel access. Patency of the LIMA bypass was verified first. The circumflex or right coronary artery respectively underwent PTCA. When the vessel diameter was larger than 2.5 mm additional stenting was performed. In all patients unfractionated heparin (100 IU/kg body weight) was administered intravenously before PTCA. If stenting was performed additionally to acetyl salicylic acid therapy the patients received a loading dose of ticlopedine (250 mg) or clopidogrel (350 mg). In the case of severe thrombus formation at the lesion site glycoprotein IIb/IIIa inhibitor was given.
Follow-up
The follow-up included clinical investigation (electrocardiogram [ECG], doppler/echocardiography, labor chemistry, and so forth) at the time of discharge. A patient interview was performed in January 2001 to document physical stress ability and postoperative recovery in order to get information of the mid-term success rate. We documented the time period the patients returned to work. Defined endpoints of the study were first (1) symptomatology class I to IV (class I, free of symptoms/angina; class II, angina during heavy exercise; class III, angina during moderate exercise; class IV, angina during low-level exercise or at rest); (2) restenosis requiring repeat PTCA (reintervention); and (3) myocardial infarction.
Coronary angiograms were performed early postoperatively and 6 months after HyR. This study examined the feasibility of PTCA early after a minimally invasive LIMA-to-LAD procedure, number of major cardiac events, mid-term outcome of target lumen reduction, bypass function, and overall risk/morbidity and mortality after the hybrid procedure. Additionally we looked specifically for radiologic signs of potential endothelial injuries of the LAD in the area of snaring.
Statistics
Age, duration of surgery, LAD occlusion time, diameter of stenosis preoperatively, diameter of stenosis postoperatively, discharge from hospital, time of follow-up, and diameter of stenosis 6 months postoperatively are presented as mean ± standard deviation. Time PTCA after surgery, time PTCA prior to surgery, lesion length, and stented vessel segment length are presented as standard error of the mean.
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Results |
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All operations were performed without intraoperative complications. No conversion to CPB was necessary. The period of coronary occlusion of 17.5 ± 8.0 minutes (5 to 53) was well tolerated by all patients even in the case of severe coronary three-vessel disease or decreased left ventricular ejection fraction (LVEF < 40%, n = 3). All patients remained hemodynamically stable postoperatively without pharmacologic support. No arrhythmias occured during LAD occlusion in any patient. Only slight ST-segment elevations of 0.9 ± 0.6 mV (0.2 to 2.4 mV) were present in 19 patients of 57. In the remaining 38 patients, the ECGs remained completely unchanged during LAD occlusion. Operation time was 135 ± 27 minutes (95 to 235). Forty-two patients were extubated in the operating room; the remaining 15 patients were extubated 4.3 ± 3.5 hours (2 to 16) after the end of surgery. There was no mortality within the first 30 postoperative days. Furthermore myocardial band creatinine kinase remained within the normal range in all patients. Transfusion was necessary in 2 patients with chronic renal failure. The mean hemoglobin value on discharge was 11.9 ± 1.1 mg/dL (8.2 to 15.7 mg/dL). In none of the patients did we observe any clinically significant deterioration of preexistent organ dysfunction. Postoperative echocardiography revealed no worsening of LV function or valve dysfunction in comparison with the preoperative echocardiography. During the postoperative course a new episode of supraventricular arrhythmia occurred in 4 patients and was converted to sinus rhythm by drugs in 2 cases and by cardioversion in the remaining 2 patients. There were no cerebrovascular events and no neuropsychiatric abnormalities observed. In 1 patient a dissection in the midlevel of the LIMA graft in the early angiographic control was detected and was stented successfully immediately. One further patient demonstrated a patent LIMA graft but a less than 50% stenosis of the anastomosis (Fitzgibbon patency class BI). All other patients demonstrated a patent LIMA-to-LAD bypass with good anastomotic result (Fitzgibbon patency class AI) in the early angiographic controls.
Interventional techniques
A total of 72 coronary lesions were successfully revascularized by catheter intervention on the 4.7 ± 0.8 postoperative day (2 to 7 days, n = 53) or 22 days (1 to 63 days; n = 4) prior to surgery (Table 3).
In all patients a PTCA was performed that was combined with stent implantation in 53 patients. The total number (n = 67) and types of stents used are summarized in Table 4.
In 43 patients only 1 lesion was treated. In the remaining 14 patients 2 (n = 13) or 3 lesions (n = 1) were treated by PTCA. In 42 patients the balloon angioplasty was performed as an outpatient procedure and in the remaining 15 patients within their hospital stay. Mean length of stenosis treated by angioplasty/stenting was 10 mm (2 to 47 mm) and severity of stenosis prior to HyR was 74.5% ± 18.7% (41% to 100%). The length of the stented vessel segment was 12 mm (8 to 96 mm) and the degree of residual stenosis directly after angioplasty was measured 8.2% ± 14.8% (0% to 23%). No major cardiac events occurred.
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Comment |
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At the beginning of our off-pump program we had only experience with LIMA-LAD procedures. After more than 20 operations we were enthusiastic about the fast recovery and the clinical outcome in these patients. We found that especially elderly patients or patients with significant comorbidity had a low perioperative risk using this approach. At that time we considered the hybrid approach to be a superior alternative especially in elderly patients with comorbidity for whom we had only the choice between conventional bypass operation or PTCA.
Complete off-pump procedures were still experimental at best and not available at our institution. Because off-pump bypass of the LAD alone seemed to be unsatisfactory in the majority of this patient-subgroup, we considered it acceptable in combination with "complete revascularization" by balloon dilatation. Furthermore it has to be considered that most of these patients included in our study were not suitable for conventional CABG.
We came to the conclusion that especially these patients with two- to three-vessel disease at high risk for conventional CABG and additionally unsuited for exclusive balloon dilatation (because of "problematic" proximal LAD lesions) were most likely to benefit from this hybrid approach.
In our study group 24 patients with serious concomitant diseases were included (Table 2). Interestingly, no patient of this high-risk group developed deterioration of preexistent organ function postoperatively. Especially no neurologic and neuropsychiatric disorders were observed even in patients with previous cerebral strokes, carotid artery stenoses, and calcification of the ascending aorta [7, 9].
Principally, to date three methods of surgical revascularization are available for patients with coronary multivessel disease without the use of CPB if the LAD lesion is not suitable for interventional techniques: first, incomplete revascularization using LIMA-LAD bypass to treat the "culprit lesion"; second, complete off-pump revascularization can be achieved using full sternotomy and deep pericardial sutures together with local stabilization; and third, the hybrid technique is used to gain complete revascularization.
Isolated LIMA-to-LAD bypass in patients with high risk for CPB and multivessel disease can be an option in selected patients in whom coronary lesions are not suitable for interventional techniques. However, disadvantages of incomplete revascularization are reported such as an increased number of myocardial infarction, a higher frequency of interventional and surgical reinterventions, and death [17]. Therefore complete revascularization should be aimed at primarily, even for patients with significant comorbidity.
Thus the hybrid concept combining minimally invasive LIMA bypass grafting to the LAD and PTCA/stenting of the remaining coronary lesions appears to be an elegant approach and a valuable alternative technique to conventional CABG [12–15]. The purpose of this method is to achieve complete coronary revascularization with early outcomes equivalent to conventional coronary artery bypass grafting but with less morbidity and mortality especially in elderly patients with severe concomitant diseases.
The first mid-term results of minimally invasive LIMA-to-LAD bypass [6, 7] demonstrate that this method is as effective in respect to patency rate as conventional CABG [18]. Furthermore several clinical studies demonstrated that conventional LIMA-to-LAD bypass grafting is more effective in preventing angina pectoris and further myocardial events in comparison with PTCA/stenting [19]. On the other hand the rate of restenosis of lesions in the right and the circumflex coronary artery undergoing PTCA/stenting is reported to be less frequent in comparison with the LAD stenosis [20]. These considerations suggest that a group of selected patients might benefit from this approach [8, 11–14].
As all patients of our study group suffered from multivessel disease, we preferred an inferior partial sternotomy for standard surgical access during minimally invasive LIMA-to-LAD bypass in order to convert to full sternotomy and cardiopulmonary bypass at any time of the operation. Using this approach the LIMA can be harvested completely under direct vision without additional instruments. Furthermore this surgical access appears in our experience to be less painful in comparison with left anterior minithoracotomy. So far we have not observed any sternum instability/osteomyelitis in more than 300 off-pump cases.
In all patients the LIMA-to-LAD procedure proved to be a safe and effective approach and anastomoses were performed successfully using the midCOAST device, which provided excellent stabilization of the area of anastomosis resulting in high quality of bypass anastomosis (Fig 1A). Myocardial preconditioning was used only in 1 patient with severe coronary three-vessel disease and stenoses of the LAD, circumflex, and occlusion of the right coronary artery who demonstrated ST-segment elevations of 2.4 mV during the period of test occlusion [5, 6]. Despite this fact and a mean LAD occlusion time of 17.5 ± 8.0 minutes there was no indication for significant myocardial damage postoperatively, which was documented by repeated tests of creatinine kinase and the myocardial band creatinine kinase [14].
Anastomotic patency rates after minimally invasive LIMA-to-LAD procedure are reported to be between 92% and 100% [7, 9]. In our group, all early postoperative angiograms demonstrated a patent LIMA-to-LAD anastomosis with the exception of 1, in whom we observed a LIMA dissection in the early postoperative angiogram. In this particular case we performed a partial ministernotomy up to the fourth instead of the third intercostal space, which probably resulted in an increase of tension on the LIMA during preparation. No further LIMA injury was observed after using a special retractor and a partial sternotomy up to the third intercostal space.
Some authors described coronary lesions in the area of snaring documented in the postoperative angiogram. For LAD occlusion and stabilization we used soft silicone loops with a blunt needle together with the stabilizer. There was no intraoperative injury and no restenosis in the area of snaring observed in the 6-month postoperative angiography [21]. A reason for this might be that snaring of the LAD is combined with the stabilizing platform of the midCOAST system minimizing tension on the LAD [8]. To date all coronary angiograms performed 6 months after surgery demonstrated a widely patent LIMA-to-LAD anastomosis of good quality. No endothelial injury or intimal hyperplasia was observed in the area of snaring.
Several authors report that perioperative need for red cell transfusion undergoing minimally invasive LIMA-to-LAD procedure is significantly reduced in comparison with conventional CABG [6]. In our study group only 2 patients undergoing hybrid revascularization received red cell transfusions. Both special patients had terminal renal dysfunction resulting in preoperative hemoglobin values between 9 and 10 mg/dL.
In the majority of cases the minimally invasive LIMA-to-LAD bypass was performed first followed by the interventional treatment of the remaining coronary lesions [11, 13, 14]. Using this sequence of procedures, patency of the LIMA bypass can be verified and balloon angioplasty of the remaining lesions—especially left main stem stenosis—can be performed more safely under "protection" of the independently and adequately perfused anteroseptal wall [11, 13, 14]. Furthermore this sequence appears to be reasonable because emergency CABG following PTCA is rare [22]. Our study patients did not suffer any major cardiac events during operation or interventional treatment.
In 4 patients PTCA/stenting was performed 1 to 63 days prior to surgery because of a high degree of stenosis in a large-size right or circumflex coronary artery and unstable angina pectoris. Despite the fact that these patients were treated with aspirin (n = 4), ticlopidine (n = 4), and glycoprotein IIb/IIIa inhibitors (n = 1) after stent implantation no increase in intraoperative and postoperative bleeding tendency was observed [23]. Therefore we propose that combining PTCA and surgery during one procedure may be a superior approach in the future because of reduced discomfort for the patient, hospital stay, and costs. However, in our series this approach was limited by the fact that the majority of patients was treated in conjunction with residential cardiologists at the referring center.
With growing experience with complete off-pump revascularization without additional PTCA the number of hybrid procedures decreased significantly during the last 2 years at our institution. Therefore our concept changed insofar that the majority of patients considered well suited for hybrid procedures 2 years ago are now primarily candidates for complete off-pump revascularization. However, we consider the hybrid approach still useful and superior to compete off-pump revascularization in patients with severe aortic calcification or mitral ring calcification in whom moving or elevating the heart during revascularization of the posterior coronary vessels might result in injury of the calcified ascending aorta or the mitral annulus.
The main limitation of this study is that it is a retrospective one. Because previous authors have described that off-pump CABG does not result in further deterioration of organ dysfunction we tried to avoid CPB in these predominantly elderly and high-risk patients. Therefore we found it not ethically justifiable to randomize these patients. At the time this study was performed a matching was actually impossible because the majority of patients were severely sick and therefore not suitable for conventional CABG. Furthermore patients were included into this trial who rejected a conventional operation with the use of CPB but agreed to an off-pump procedure. Complete off-pump procedures were still experimental at best and not available at our institution. Because off-pump bypass of the LAD alone seemed to be unsatisfactory in the majority of this patient-subgroup we considered it acceptable in combination with "complete revascularization" by balloon dilatation. A further limitation is that no cost analysis had been performed and that data acquisition was incomplete due to the missing patient consent for repeat angiography. However, despite the fact that 12 patients gave no consent for repeat angiography and 8 patients had contraindications (severe renal impairment) we decided to include even those not amenable for coronary angiography because the clinical outcome and subjective cardiac symptomatology in our opinion seemed to be worthwhile to be included in the paper. Additionally one important subgroup (patients with severe renal insufficiency) would have been completely omitted in our data.
In conclusion these preliminary results indicate that selected patients with coronary two and three-vessel disease including left main stem stenosis can be treated effectively and securely by hybrid revascularization with good early and mid-term results. Especially patients with coronary artery disease and severe concomitant disease appear to benefit from hybrid procedures because preexistent organ dysfunction is not additionally compromised by cardiopulmonary bypass. Catheter interventions can be performed safely and effectively within the first postoperative days after minimally invasive LIMA-to-LAD bypass surgery. Mid-term results of off-pump LIMA-to-LAD bypass are good and comparable with the on-pump approach. Thus far this approach is limited by the restenosis rate after balloon angioplasty, which may increase the costs to the health care system. On the other hand these special patients who seem neither to be suitable for off- nor for complete on-pump revascularization benefit mostly from the hybrid approach because life-threatening complications with long intensive care unit stays might be avoided.
Definitely, the specter of restenosis after PTCA is the major disadvantage of the hybrid approach. Newer interventional techniques as, for example, coated stents may lower the incidence of restenosis rates and may result in some shift backward to hybrid procedures.
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