Hybrid Revascularization Using Percutaneous Coronary Intervention and Robotically Assisted Minimally Invasive Direct Coronary Ar

Minimally invasive direct coronary artery bypass (MIDCAB) has been successfully used to treat isolated lesions of the left anterior descending (LAD) artery by operating on the beating heart without cardiopulmonary bypass (CPB) with excellent medium-term results.1 MIDCAB involves open harvesting of the left internal thoracic artery (LITA) through a small left anterior thoracotomy incision or lower hemisternotomy incision (Figure 1). The LITA is then sewn directly to the LAD on the beating heart through this limited opening. MIDCAB has been associated with improved cosmetic results and quicker recovery time when compared with traditional sternotomy.2 Likewise, the avoidance of CPB spares the patient the risks associated with activation of the complement, coagulation and fibrinolysis systems and alterations in red blood cells, leukocytes and platelets, which may result in bleeding and thromboembolic complications, such as stroke.2–6 MIDCAB is also associated with a lower cost than coronary artery bypass grafting (CABG).7 It may be the preferred choice of surgical revascularization in elderly, comorbid and reoperated patients with type B or C lesions. The techniques of conventional MIDCAB recently have been refined with the use of robotic technology. The Da Vinci robotic system™ (Intuitive Surgical, Sunnyvale, California) employs fine instruments that simulate the motion of the human wrist (Figure 2). The surgeon controls the instruments at a separate operating console. Hand motions are scaled through a computer interface to eliminate tremor, allowing for precise maneuvers through very small (8 mm) incisions. The surgeon views the operation stereoscopically through the operating console, which allows for real-time three-dimensional vision. With the use of the Da Vinci robotic system, the LITA can be mobilized through three 8 mm ports, avoiding the chest wall trauma associated with open LITA harvesting through a small thoracotomy incision. Likewise, the pericardium may be opened and the LAD identified totally endoscopically prior to making an incision. This allows for a directed small incision over the LAD via either a limited lower hemisternotomy or a limited left anterior thoracotomy, further decreasing surgical tissue trauma. Hybrid revascularization (HR) combines staged percutaneous coronary intervention (PCI) on stenoses in the non-LAD territories with MIDCAB using the LITA to the LAD. The LITA-to-LAD graft, which has a 5-year patency rate of 95%, is the major determinant of the long-term survival for patients.8 Thus, HR aims to achieve full revascularization without compromising the survival advantage of the LITA-to-LAD graft, while preserving the minimally invasive advantages of the percutaneous treatment of symptomatic coronary stenoses. Since April 2002, our institution has used HR in selected patients as an alternative to conventional CABG with multivessel coronary artery disease (CAD) involving the LAD. We investigated whether HR was a valid alternative to conventional CABG in patients with multivessel CAD. As a quality assurance project, we present in this paper our early experiences with HR using a combined approach of advanced PCI and robotically-assisted MIDCAB. Methods Patient selection. From April 2002 to October 2002, a total of 6 patients underwent HR. In this series, the HR sequence in all cases included a PCI performed in the cardiac catheterization laboratory followed by a robotically-assisted MIDCAB with an average time of 2.0 ± 0.9 days later. All patients subsequently underwent repeat coronary angiography. Percutaneous coronary intervention. PCI was performed using femoral artery access with 6 French guiding catheter techniques. The right coronary artery (RCA) and left circumflex artery (LCX) underwent PCI when appropriate. All patients received intravenous unfractionated heparin (70 U/kg body weight) before PCI. Aspirin 325 mg was given routinely, and clopidigrel 300 mg and glycoprotein IIb/IIIa receptor antagonist were given at the operator’s discretion. If glycoprotein blockade was chosen, it was stopped at least 12 hours prior to surgery; if clopidigrel was given, it was given only on the day of the PCI and was subsequently restarted after MIDCAB. Patients were heparinized post-surgery, and given aspirin 325 mg and clopidogrel 75 mg daily when again able to take medications orally. Surgical technique. The patients were positioned in the supine position with a roll to elevate the left shoulder and the left arm supported at the side of the bed. With single lung ventilation and chest cavity insufflation, the robotic arms were inserted through 3 small ports in the left chest. The LITA was then dissected from the subclavian artery to its bifurcation.. The pericardium was then opened with the robot, and the LAD was identified. If the LAD was not intramyocardial and appeared amenable to off-pump surgery, heparin (100 U/kg body weight) was given, and the LITA was transected and prepared robotically. The robot was then removed and a lower hemisternotomy incision was performed through a 6 cm incision and “t’ed” off into the third left intercostal space. A stabilizing retractor was positioned and the anastomosis performed on the beating heart. All patients were extubated in the operating room or shortly after surgery in the intensive care unit. Results Patient #1. A 55-year-old male with hypertension, diabetes mellitus, hypercholesterolemia and a history of cigarette smoking presented with progressive angina pectoris. Coronary angiography revealed a normal left main (LM) artery, a calcified LAD with a high-grade proximal lesion, a moderate lesion in the first obtuse marginal branch of the LCX, and a high-grade lesion in the mid-RCA. Left ventriculography demonstrated an ejection fraction of 45%. The RCA was predilated with a 3.0 x 15 mm Maverick balloon (Boston Scientific/Scimed, Inc., Maple Grove, Minnesota) and stented with a 3.0 x 13 mm HepaCoat Bx Velocity stent (Cordis Corporation, Miami, Florida) with excellent results. The patient was treated with eptifibatide for 12 hours and aspirin only on the day of the PCI, but was not treated with clopidogrel. Two days later, a robotically-assisted MIDCAB utilizing the LITA to the LAD without CPB was performed without the need for blood transfusion. The patient was extubated 4 hours post-MIDCAB and transferred to the intensive care unit. He was discharged from the hospital on his fourth postoperative day without complications and returned to work 7 days postoperatively. At 12-month follow-up, the patient complained of recurrence of angina. Repeat coronary angiography demonstrated a high-grade lesion at the site of the distal anastomosis of the LITA-to-LAD graft. Subsequently, the LAD was predilated with a 3.0 x 30 mm Maverick balloon. The mid-LAD was then stented with a 2.75 x 28 mm Zeta stent (Guidant Corporation, Santa Clara, California), and the proximal LAD was stented with a 3.0 x 23 mm Zeta stent. The proximal and mid-LAD was postdilated with a 3.5 x 8 mm noncompliant balloon with excellent results. At 22-month follow-up, there was no recurrence of angina and no cardiovascular events. Patient #2. A 49-year-old male with hypertension, family history of premature coronary artery disease and a history of cigarette smoking presented with an acute anterior ST-segment elevation myocardial infarction that was treated with thrombolytic therapy. The patient was referred for cardiac catheterization the following day after experiencing post-infarction angina. Coronary angiography revealed a codominant system with a normal LM, a severe diffuse type C lesion in the mid-LAD, high-grade lesions in the LCX and the first and third obtuse marginal branches, and a high-grade lesion in the proximal RCA, which was a small-caliber vessel and not intervened upon. Left ventriculography demonstrated an ejection fraction of 35%. The distal LCX was stented with a 3.0 x 8 mm Penta stent (Guidant Corporation) with excellent results. The proximal LCX was stented with 4.5 x 18 and 4.5 x 13 mm Ultra stents (Guidant Corporation). A 3.0 x 10 mm Cutting Balloon (InterVentional Technologies, Inc., San Diego, California) was inflated in the first obtuse marginal branch. The patient was treated with eptifibatide for 12 hours and aspirin and clopidogrel only on the day of the PCI. Two days later, a robotically-assisted MIDCAB of the LITA to the LAD without CPB was performed without the need for blood transfusion. The patient was extubated 4 hours post-MIDCAB and transferred to the intensive care unit. He was discharged from the hospital on his third postoperative day, without complications. At 20-month follow-up, coronary angiography was performed because of a positive stress test. Coronary angiography revealed patent LCX stents and LITA-to-LAD graft and no further progression of native coronary artery disease. Patient #3. A 69-year-old male with hypertension, hypercholesterolemia and Meniere’s disease presented with progressive angina pectoris. Coronary angiography revealed a left dominant system with a thrombus in the LM, ramus intermedius branch and proximal LAD. The proximal LAD also had a high-grade lesion. There was a severe lesion in the distal LCX. The RCA was non-dominant and minimally diseased. Left ventriculography demonstrated an ejection fraction of 50%. The distal LCX was predilated with a 4.0 x 15 mm Maverick balloon and stented with a 4.5 x 13 mm Ultra stent with excellent results. The patient was treated with eptifibatide for 12 hours and aspirin and clopidogrel only on the day of the PCI. Three days later, the LITA was mobilized robotically, but had poor flow after takedown. The MIDCAB was converted to on-pump CABG with the right internal thoracic artery anastomosed to the LAD because of a very deep intramyocardial LAD that could not be safely dissected on the beating heart. The angiogram was not suggestive of such a long intramyocardial course. No blood products were required. The patient was extubated 9 hours later and discharged home on his fourth postoperative day, without complications. At 10-month follow-up, the patient complained of recurrence of angina. Repeat coronary angiography demonstrated a high-grade lesion in the ostium of the ramus intermedius branch and a patent right internal thoracic artery-to-LAD graft. Subsequently, a 2.75 x 10 mm Cutting Balloon was inflated in the ramus intermedius branch with excellent results. Patient #4. A 65-year-old male with hypertension presented with new onset of angina pectoris. Coronary angiography revealed a moderate lesion in the LM, a high-grade lesion in the proximal LAD, a moderately severe lesion in the proximal LCX and a 70% stenosis in the mid-RCA. Left ventriculography demonstrated an ejection fraction of 35%. The RCA was predilated with a 3.0 x 20 mm Maverick balloon, stented with a 4.0 x 23 mm Penta stent and postdilated with a 4.5 x 15 mm noncompliant balloon with excellent results. The patient was treated with eptifibatide for 12 hours and aspirin and clopidogrel only on the day of the PCI. One day later, a robotically-assisted MIDCAB of the LITA to the LAD without CPB was performed without the need for blood transfusion. The patient was extubated 6 hours post-MIDCAB and transferred to the intensive care unit. He was discharged from the hospital on his third postoperative day, without complications. At 18-month follow-up, coronary angiography was performed because of a positive stress test. Coronary angiography revealed a patent RCA stent and LITA-to-LAD graft and no further progression of native coronary artery disease. Patient #5. A 57-year-old male with hypertension and hypercholesterolemia presented with progressive angina pectoris. Coronary angiography revealed mild disease in the LM, a high-grade lesion in the mid-LAD and the proximal diagonal branch (Figure 3). The LCX and RCA were minimally diseased. Left ventriculography demonstrated an ejection fraction of 50%. The diagonal branch was predilated with a 2.5 x 10 mm Cutting Balloon and stented with a 2.5 x 23 mm Bx Velocity stent with excellent results. The patient was treated with eptifibatide for 12 hours and with aspirin and clopidogrel only on the day of the PCI. One day later, a robotically-assisted MIDCAB of the LITA to the LAD without CPB was performed without the need for blood transfusion. The patient was extubated 2 hours post-MIDCAB and transferred to the intensive care unit. He was discharged from the hospital on his third postoperative day, without complications. At 11-month follow-up, coronary angiography was performed because of recurrence of angina. Coronary angiography revealed in-stent restenosis of the diagonal branch of the LAD and a moderate-grade lesion at the site of the distal anastomosis of the LITA-to-LAD graft. Subsequently, the diagonal branch was stented with a 2.5 x 23 mm Cypher stent (Cordis Corporation) with excellent results. Patient #6. A 59-year-old male with CAD status after a silent anterior myocardial infarction, who had diabetes mellitus, hypertension and hypercholesterolemia, presented with progressive angina pectoris. Coronary angiography revealed mild disease in the LM and an occluded proximal LAD with collateral flow from the RCA. The LCX and first obtuse marginal branch were moderately diseased. There was a severe complex lesion in the proximal and mid-RCA. Left ventriculography demonstrated an ejection fraction of 20%. The mid-RCA was predilated with a 2.75 x 20 mm Maverick balloon, stented with a 3.5 x 20 mm Radius stent (Boston Scientific/Scimed, Inc.) and postdilated with a 4.0 x 20 mm noncompliant balloon with excellent results. The proximal RCA was stented with a 4.0 x 31 mm Radius stent with excellent results. The patient was treated with eptifibatide for 12 hours and with aspirin and clopidogrel only on the day of the PCI. A robotically-assisted MIDCAB of the LITA to the LAD without CPB was performed without the need for blood transfusion 3 days later rather than 1 day later because of the weekend. The patient was extubated 4 hours post-MIDCAB and transferred to the intensive care unit. He was discharged from the hospital on his fourth postoperative day, without complications. At 3-month follow-up, coronary angiography was performed because of a positive stress test. Coronary angiography revealed a patent RCA stent and LITA-to-LAD graft and no further progression of native coronary artery disease. Discussion HR provides several advantages over conventional CABG, especially in high-risk patients with LM disease, left ventricular systolic dysfunction, advanced age, prior CABG and comorbidities, who are poor surgical candidates for on-pump CABG and who are not likely to tolerate CPB well.9 In this fashion, off-pump MIDCAB is expected to show lower mortality and morbidity rates than conventional on-pump CABG with CPB, since it does not necessitate the cross-clamping of the aorta with its attendant stroke rate, has a lower chance of hemodynamic shifts when going on and off CBP, has a superior cosmetic result, and avoids the pulmonary embarrassment of the sternotomy.10 Patients may thus recover faster with shorter lengths of stay in the hospital and return to work more quickly than with conventional CABG.7 In addition, the perioperative need for blood transfusion in patients undergoing HR is reduced when compared to conventional CABG.11 LAD balloon angioplasty has been associated with a higher likelihood of restenosis when compared with LCX and RCA;12 however, this excess LAD restenosis has not been demonstrated for stenting. Nonetheless, the tremendous mortality advantage conferred by a successful LITA-to-LAD graft has never been proven with either PCI or any other surgical conduit. Thus, LITA-to-LAD MIDCAB may be preferable as part of a strategy for life-long revascularization, and especially in situations where the LAD is not ideal for PCI. Anatomic circumstances, such as highly calcified, tortuous and bifurcation lesions, and long or tandem stenoses, may be considered to be good targets for this approach. Although no difference could be shown between MIDCAB and balloon angioplasty in 1-year survival and major adverse clinical events in type C lesions of the LAD, MIDCAB was associated with fewer repeat PCIs when compared to angioplasty.13 The ARTS trial showed that coronary stenting for multivessel CAD was less expensive than CABG and offered the same degree of protection against death, stroke and myocardial infarction, but stenting was associated with a greater need for a second revascularization procedure.14 However, in that study, the event-free 1-year survival rate in diabetic patients treated with stenting was lower compared with CABG (63.4% versus 84.4%; p Study limitations. We present data with a relatively low number of patients. Long-term results with more patients and angiographic follow-up will be needed to determine whether HR is as reliable as conventional CABG with CBP. Conclusion. HR, which combines PCI with LITA-to-LAD MIDCAB, is less invasive than conventional CABG, appears to be safe, and is another option in selected patients with multivessel CAD involving the LAD. HR, although more technically demanding, achieves early complete revascularization including the specific life-extending benefits of LITA-to-LAD grafting in selected patients, but with minimal postoperative morbidity. There is usually an uneventful perioperative course with an anticipation of early recovery and discharge. This may be an alternative to conventional CABG in high-risk patients, such as the very elderly and patients with comorbidities (especially pulmonary disease) by avoiding midsternotomy and CBP. HR may also be another option for healthier and younger patients with multivessel CAD who are not optimal candidates for pure PCI due to specific coronary anatomic concerns. Although studies are currently underway with excellent early and good mid-term results, there are no large-scale randomized clinical trials looking at the results of HR. In addition, there is no long-term follow-up in HR patients. Specific indications for HR must be defined by large, prospective, randomized multicenter studies comparing HR and conventional CABG to clarify which revascularization technique is superior long term for the treatment of multivessel CAD. HR has been limited by the results of PCI and the need for repeat PCI, which may increase the costs on the healthcare system. Drug-coated stents substantially decrease this phenomenon, as has been shown with sirolimus and paclitaxel coating. Given the low incidence of in-stent restenosis with drug-coated stents, the future role of HR is unclear in patients with multivessel CAD involving the LAD if comparable results may be attained with multivessel PCI.

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