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Ann Thorac Surg 1997;63:1742-1747
© 1997 The Society of Thoracic Surgeons

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Original Article: Cardiovascular

Initial Experience Using an Intraluminal Shunt During Revascularization of the Beating Heart

Hospital Samaritano, Faculdade De Ciencias Medicas Santa Casas, São Paulo, Brazil

Accepted for publication January 3, 1997.

	Abstract

Top Footnotes Abstract Introduction Material and Methods Patient Selection Criteria The Device Surgical Technique Postoperative Care Results Comment Addendum Acknowledgments References

 
Background. For decades, surgeons have relied on extracorporeal circulation and induced cardiac asystole to provide a bloodless, motionless field in which to construct coronary bypass grafts. However, the technique of coronary grafting without heart-lung support is now being revitalized. The current resurgence of off-pump coronary artery bypass grafting and the advent of less invasive incisions make it imperative that technical advances be applied to maximize the safety of these procedures.

Methods. This report describes an inexpensive intraluminal shunt that maintains coronary perfusion, prevents ischemia, reduces backbleeding, and molds the suture line to prevent accidental missuturing of the posterior coronary wall.

Results. In 63 patients, saphenous grafts were placed to the left anterior descending (49), diagonal (9), and right coronary artery (27) without extracorporeal circulation using an intraluminal shunt. There were no deaths (0% mortality) and one perioperative infarction (1.5%). Complication and graft patency rates were comparable with those obtained by conventional techniques.

Conclusions. Temporary intraluminal shunting greatly facilitates the surgeons' operative environment by permitting safe and precise construction of coronary artery grafts on the beating heart in a bloodless field. Intraluminal shunting may have future implications on the ability to perform safe and reproducible grafting on the beating heart through minimally invasive or endoscopic approaches.

	Introduction

Top Footnotes Abstract Introduction Material and Methods Patient Selection Criteria The Device Surgical Technique Postoperative Care Results Comment Addendum Acknowledgments References

 
See also page 1747.

Following the original coronary revascularization procedures in the late 1960s, surgeons have faced and solved many technical problems culminating in dramatic improvements in both risk and outcome. Gradual advancements in surgical equipment, myocardial preservation, anesthesia, and nursing care have now made it possible to perform elective coronary revascularization with minimal morbidity and mortality.

Although the use of the heart-lung bypass circuit is certainly routine in modern coronary surgery, the systemic and hematologic effects of extracorporeal circulation (ECC) are still evident in the complication spectrum seen in postoperative patients. Neurologic events (both focal and neuropsychiatric), vascular complications, aortic trauma/dissection, atheroemboli, coagulopathy, vasomotor changes (such as arterial vasoconstriction), fever, and other side effects are due, at least in part, to the routine use of ECC. Even the advent of membrane oxygenators, pulsatile flow, and powerful antiinflammatory medications have not eliminated the sequelae that occur after the use of ECC and exposure of the patient's blood to the pump circuit.

Although cardiopulmonary bypass (CPB) permits the surgeon to suspend cardiac action and operate in a motionless field, the necessity of this technology for every revascularization procedure is being questioned once again. Off-pump coronary grafting is certainly not new. A review of the history of coronary artery bypass grafting (CABG) shows that the original cases reported by Favaloro [1], Sabiston [2], Murray [3], and others were all performed without the pump oxygenator. Ankeney [4] reported his experience with 143 cases in 1972, but his presentation was severely criticized by his colleagues. In 1975 Trapp and Bisarya [5] were the first to report on the use of a temporary intraluminal shunt to facilitate construction of coronary grafts without ECC. Their approach was not widely accepted due to perceived complexities.

Just in the past few years a shift in emphasis has taken place within the discipline of cardiothoracic surgery. This reorientation was induced by economic factors as well as the successful evolution of video-assisted and minimally invasive techniques in other surgical specialties. Furthermore, several cardiac centers are now reporting significant numbers of patients undergoing CABG without CPB. Buffolo [6], Benetti [7], Pfister [8], Fanning [9], and others have recently shown excellent results when performing off-pump CABG (Table 1). In selected patients, the operative mortality, morbidity, perioperative infarction rates, length of hospital stay, and hospital costs were all reduced when compared with similar patients operated on with heart-lung support.

	Material and Methods

Top Footnotes Abstract Introduction Material and Methods Patient Selection Criteria The Device Surgical Technique Postoperative Care Results Comment Addendum Acknowledgments References

 
Study Group
From November 1983 to July 1991, sixty-three consecutive patients (46 male and 17 female patients) underwent CABG without extracorporeal circulation at the Santa Casa de São Paulo Hospital and Samaritano Hospital with the aid of a temporary intraluminal shunt (TIS) designed by us. Surgical protocols were approved by the Institutional Human Research Committee. Patient age ranged from 34 to 75 years (mean, 57.1 years). No patient had undergone previous cardiac surgery. Prior myocardial infarction was present in 37 patients (58.7%), chronic obstructive pulmonary disease in 13 (20.6%), diabetes mellitus in 12 (19%), and systemic arterial hypertension in 17 (27%). Severe left ventricular dysfunction (ejection fraction less than 0.3) was present in 7 (11.1%), whereas moderate left ventricular dysfunction (ejection fraction of 0.3 to 0.4) was present in 9 patients (14.3%). Acute coronary syndromes were present in 55 patients (87.4%): stable angina, 8 (1.6%); unstable angina, 21 (33.3%); postinfarction angina, 17 (26.9%); postinfarction angina + thrombolysis, 4 (6.3%); coronary angioplasty, 6 (9.5%); and coronary angioplasty + thrombolysis, 1 (1.6%). No patient was excluded based on ejection fraction, hemodynamics, or organ dysfunction (renal, hepatic, or pulmonary).

	Patient Selection Criteria

Top Footnotes Abstract Introduction Material and Methods Patient Selection Criteria The Device Surgical Technique Postoperative Care Results Comment Addendum Acknowledgments References

 
The following criteria were used prospectively to select patients for CABG without heart-lung support in conjunction with intraluminal shunting:

1. Angina or electrocardiographic evidence of persistent ischemia.
   
2. Coronary vessels with hemodynamically significant stenosis (greater than 70% luminal narrowing).
   
3. Adequate target vessel (of at least 1.5 mm diameter) without distal calcifications or stenosis.
   
4. Target vessels included the left anterior descending, the diagonal, or the right coronary artery but not the posterior descending artery or obtuse marginal branches of the circumflex artery.
   

Patients with intramyocardial coronary arteries were not excluded. However, in cases where the target vessel was thought to be intramyocardial, CPB equipment was prepared and kept in reserve. In no case was institution of emergent CPB needed.

	The Device

Top Footnotes Abstract Introduction Material and Methods Patient Selection Criteria The Device Surgical Technique Postoperative Care Results Comment Addendum Acknowledgments References

 
The Rivetti shunt [15] is fashioned from a 3-cm segment of smooth, transparent, externally polished medical grade silicone tubing (#602-175 or #602-205; Dow Corning, Midland, MI) (Fig 1). Each end is tapered to facilitate entry into the coronary lumen. The midpoint of the shunt is secured with an encircling 4-0 polypropylene retention suture to permit easy withdrawal after completion of the anastomosis (Fig 2).

View larger version (145K): [in this window] [in a new window]   Fig 1. . Three-centimeter segments of silicone tubing (varying diameters).

View larger version (90K): [in this window] [in a new window]   Fig 2. . Temporary intraluminal shunt.

	Surgical Technique

Top Footnotes Abstract Introduction Material and Methods Patient Selection Criteria The Device Surgical Technique Postoperative Care Results Comment Addendum Acknowledgments References

Proximal and distal control of the coronary artery at the site of anticipated anastomosis is obtained with encircling sutures and snares composed of 4-0 polypropylene or silicone Retract-o-tapes (Quest Medical, Dallas, TX) (Fig 3). Because the plan to use the intraluminal shunt is finalized in advance, a period of ischemic preconditioning or test occlusion is not used. The arteriotomy is performed at the chosen site using a #69 Beaver blade. Then the shunt is advanced into the proximal coronary lumen using a thumb forceps (Fig 4). Brisk flow through the device signals proper entry and facilitates deairing. The remaining end is then introduced into the distal coronary artery and the snares are gently reapplied. Apposition of the coronary wall to the shunt eliminates bleeding except from the occasional minor side branch that arises within the arteriotomy. The TIS prevents ischemia by perfusing the distal bed while at the same time permitting unhurried careful suturing. In addition, the TIS supports the coronary edges, making it impossible to catch the posterior wall in any suture (Fig 5). Coronary anastomosis is performed with a double-armed 7-0 Prolene (Ethicon Somerville, NJ) continuous suture. Before the suture is secured, the anastomosis is opened and the TIS removed by traction on the retention suture (Fig 6).

View larger version (20K): [in this window] [in a new window]   Fig 3. . Local control of the target vessel with loop sutures and snares.

View larger version (27K): [in this window] [in a new window]   Fig 4. . Insertion and deairing of intraluminal shunt. (TIS = temporary intraluminal shunt.)

View larger version (23K): [in this window] [in a new window]   Fig 5. . Intravascular position of shunt, which holds open the arteriotomy. (TIS = temporary intraluminal shunt.)

View larger version (106K): [in this window] [in a new window]   Fig 6. . Removal of the temporary intraluminal shunt before completion of the anastomosis.

	Postoperative Care

Top Footnotes Abstract Introduction Material and Methods Patient Selection Criteria The Device Surgical Technique Postoperative Care Results Comment Addendum Acknowledgments References

	Results

Top Footnotes Abstract Introduction Material and Methods Patient Selection Criteria The Device Surgical Technique Postoperative Care Results Comment Addendum Acknowledgments References

 
There were 49 left anterior descending, 9 diagonal, and 27 right coronary artery grafts placed in 63 consecutive patients for an average of 1.35 grafts/patient. Among the 63 patients, 43 single bypass operations (68.2%), 18 two-vessel (28.6%), and 2 triple bypass procedures (3.2%) were accomplished. Mean shunt time was 12 minutes. Total insertion and removal time averaged 40 seconds. No intraoperative thrombosis developed in any shunt. No injury to either the native coronary artery or the donor graft occurred during removal of the shunt in any case.

There were no hospital deaths (0% mortality) and only one perioperative myocardial infarction (1.5%). Complications rates did not differ from those reported by others using CPB:

Coagulopathy developed in 2 patients (one from alcoholic cirrhosis and the second from passive hepatic congestion in combination with preoperative aspirin).

Postoperative coronary cineangiography was performed in 21 patients. Indications for angiography were primarily recurrent chest pain symptoms or a positive screening treadmill test. The early graft patency rate was 84.3%. Two patients (9.5%) had occlusion of one out of two grafts. Two other patients (9.5%) with single-vessel disease had occlusion of their solitary graft. Seventy-six percent of patients had all grafts intact. Only 1 patient (4.7%) had slow flow in a graft due to a new lesion distal to the anastomosis.

	Comment

Top Footnotes Abstract Introduction Material and Methods Patient Selection Criteria The Device Surgical Technique Postoperative Care Results Comment Addendum Acknowledgments References

 
The goal of coronary artery surgery is direct revascularization of the ischemic zone with an extraanatomic bypass conduit. The clinical effectiveness of CABG in preventing angina recurrence has now been demonstrated in multiple studies, some also showing prologation of life in certain subgroups. Surgical grafting has resulted in the most uniform, effective, and durable relief of angina, even when compared with newer transcatheter approaches. However, successful CABG requires that the operator achieve a precise and error-free connection between the donor and recipient vessels. To facilitate suturing of vascular channels that range down to 1.0 mm in diameter, nearly all surgeons employ heart-lung support and some form of induced cardiac asystole. The operative environment permitted by CPB and asystolic arrest favors the surgeon by creating a truly motionless, bloodless field in which precise and delicate suturing can be done on every vessel of the heart. The past two decades of surgical research have been directed mainly toward improvements in myocardial protection so that this operative strategy could be applied with minimal detriment to the myocardium. Induced ventricular fibrillation without cross-clamping [16], intermittent cross-clamping [17], topical hypothermia [18], single or multidose crystalloid cardioplegia [19, 20], blood cardioplegia [21], and now retrograde delivery of cardioplegia [22, 23] have all been introduced and refined by different centers with varying results. Despite documented improvements in myocardial protection when using multidose or continuous cardioplegia, there still remains a 4% incidence of perioperative infarction and a 5% incidence of low cardiac output syndrome requiring intraaortic counterpulsation when CABG is performed with asystolic cardiac arrest. Newer and more novel strategies such as substrate-enhanced cardioplegia [24] and warm hyperkalemic cardiac arrest [25] with continuous perfusion have recently been introduced, but with added cost and complexity in the operative environment.

In recent years, reports have emerged from several centers that have revitalized or retained the technique of performing selected CABG cases without ECC. There are now admirable results reported in more than 1,700 cases where CABG was performed without CPB (see Table 1). Benetti and associates [7] and Pfister and colleagues [8] have also demonstrated a reduction in hospital morbidity and mortality in elderly patients when coronary grafting is performed without ECC compared with historical controls operated on with ECC. Similar trends in reduced hospital length of stay, total operative times, transfusion requirements, incidence of low output syndrome, and overall surgical mortality were reported by Pfister and colleagues [8]. The feasibility of performing repeat CABG ("redo") without CPB has also been shown [9].

In the current series, application of a temporary intraluminal shunt was the one intraoperative technical maneuver that made it possible to achieve excellent results while performing CABG without CPB. In this initial series of 63 patients, there were no deaths. In contrast, our perioperative mortality in the same era for patients undergoing CABG using ECC was 5.3%. The graft patency and complication rates obtained off-pump were similar to those reported by other centers using heart-lung support.

Documentation of actual flow through the intraluminal shunt could not be done in any quantitative fashion. However, clinical evidence of shunt flow is definitely observed. For example, it is common to visualize a sharp increase in the pink color of the myocardium after implanting the shunt. Additionally, in one case third-degree atrioventricular block occurred upon occlusion of the right coronary artery, which resolved quickly after placement of the TIS. In another patient, left bundle-branch block developed when the TIS was threaded into the proximal left anterior descending artery. This was probably due to impingement of a septal perforator by the shunt and disappeared when the TIS was replaced with a modified TIS (including a posterior longitudinal split).

An important determinant of success when using the TIS for off-pump CABG is patient selection, particularly in regard to the size and quality of the target coronary artery. Calcification, diffuse disease, and small luminal diameter are all factors that make it difficult to perform coronary grafting on the beating heart.

With the use of temporary intraluminal shunting, several of the technical hazards of off-pump CABG can be dealt with or prevented. First, the shunt effectively prevents ischemia from occurring during the time of vascular control and suturing. Because blood flow is not totally interrupted, there is less ischemia and improved myocardial tolerance. This eliminates the risk of sudden hemodynamic compromise forcing the surgeon to take emergency measures. Preconditioning, chemically induced bradycardia, and dependency on myocardial vasodilators that produce systemic hypotension are all avoided. Without the TIS, ischemia occurs unpredictably in 20% to 30% of CABG cases performed on the beating heart. In our experience, the shunt eliminated this unpredictable event, making the operation safer and easier on the patient, surgeon, and anesthesiologist. Furthermore, the TIS provides significant advantages to the surgeon by maintaining the field free of blood as well as preventing suture mishaps such as inadvertent stitching of the back wall of the coronary artery. These synergistic advantages sum up to an operative situation where the surgeon can create a precise suture line in an unhurried, safe environment.

No known case of intraluminal shunt thrombosis occurred. Furthermore, removal of the shunt was uneventful in every case. Under traction the soft, pliable silicone tube will fold like a butterfly wing and can be slid out through a gap in the suture line. No patient suffered damage to the anastomosis during removal. One patient may have suffered an intimal injury from the encircling distal snare as evidenced by a stenosis several months postoperatively. Since that time, the distal snare has not been used unless absolutely required for hemostasis.

The shunt does nothing to reduce the rocking motion of the heart. However it does effecively prevent ischemia, maintain a bloodless field, expand and stent the suture line, and significantly ease the surgeon's task by permitting careful and diligent suturing without hurry. We have successfully used shunts in vessels down to 1.0 mm in size. Custom sizes and configurations, including shunts with perfusion side limbs, are now under development. As surgical experience with TIS during off-pump CABG increases, a greater range of patients may be approached with increasing margins of safety but without any increase in cost. Based on the series of patients reported here, we continue to expand our clinical use of this device, including cases now operated on through less invasive incisions. The role of TIS during endoscopic or videothoracoscopic surgical bypass is another potentially fruitful area.

	Addendum

Top Footnotes Abstract Introduction Material and Methods Patient Selection Criteria The Device Surgical Technique Postoperative Care Results Comment Addendum Acknowledgments References

 
Since this initial cohort was completed in 1991, an additional 419 patients (317 male and 102 female patients) underwent grafting by us using the same intraluminal shunt and the surgical techniques outlined in this report. A mean of 1.6 grafts per patient were constructed including 152 left internal mammary-to-left anterior descending artery grafts. The surgical mortality for this second group was only 1.43% (6 patients) and the perioperative infarction rate was only 1.67% (7 patients). The incidence of mediastinitis was 1.6% (compared with 1.5% in patients operated on using CPB).

	Acknowledgments

Top Footnotes Abstract Introduction Material and Methods Patient Selection Criteria The Device Surgical Technique Postoperative Care Results Comment Addendum Acknowledgments References

	Footnotes

Top Footnotes Abstract Introduction Material and Methods Patient Selection Criteria The Device Surgical Technique Postoperative Care Results Comment Addendum Acknowledgments References

 
Address reprint requests to Dr Rivetti, Rua Conselheiro Brotero, 1486 CEP 01232-010, São Paulo SP/Capital, Brazil.

	References

Top Footnotes Abstract Introduction Material and Methods Patient Selection Criteria The Device Surgical Technique Postoperative Care Results Comment Addendum Acknowledgments References

 

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