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(Radiology. 2000;215:594-599.)
© RSNA, 2000

Technical Developments

Endovascular Stent-Graft Deployment: Temporary Vena Caval Occlusion with Balloons to Control Aortic Blood Flow-Experimental Canine Study and Initial Clinical Experience1

Tsuneo Ishiguchi, MD, Naomichi Nishikimi, MD, Akihiko Usui, MD and Takeo Ishigaki, MD

1 From the Departments of Radiology (T. Ishiguchi, T. Ishigaki), First Department of Surgery (N.N.), and Thoracic Surgery (A.U.), Nagoya University School of Medicine, 65 Tsurumai-cho, Showaku, Nagoya 466-8550, Japan. From the 1998 RSNA scientific assembly. Received March 5, 1999; revision requested June 2; revision received July 2; accepted July 22. Address correspondence to T. Ishiguchi (e-mail: ishiguti@met.nagoya-u.ac.jp).


   Abstract
TOP
 Abstract
Introduction
 Materials and Methods
 Results
 Discussion
 References
 
Vena caval occlusion was evaluated in animal experiments. In five patients with thoracic aortic aneurysms, two balloon catheters were introduced via the femoral vein to the inferior vena cava and superior vena cava and inflated before stent-graft deployment. Aortic pressure and flow were immediately decreased, which minimized the downstream shift of the stent-grafts. Temporary vena caval occlusion is safe and effective for precise aortic stent-graft deployment.

Index terms: Aneurysm, aortic, 943.73, 981.73 • Animals • Aorta, grafts and prostheses, 943.1268, 981.1268 • Grafts, interventional procedures, 943.1268, 981.1268 • Venae cavae, interventional procedures, 946. 1268, 982.1268


   Introduction
TOP
 Abstract
 Introduction
Materials and Methods
 Results
 Discussion
 References
 
Endovascular stent-graft placement was developed for the treatment of aortic aneurysm as a less invasive alternative to open surgery in selected patients (1–8). The primary success rates for endovascular stent-graft placement of thoracic and abdominal aneurysms are 75%–96% (6,9–12). However, persistent filling of the aneurysm or leak may be demonstrated in 11%–32% of patients after the initial procedure (6,7,10–14), and secondary interventions including additional stent-graft placement or transcatheter embolization are required for the treatment of a persistent perigraft leak, which is considered a potential cause of aneurysmal rupture (3,9–16). Development of a perigraft leak is related to various factors including anatomy of the aneurysm and the aortic neck, design and size of the device, retrograde flow via the side branches, and deployment techniques (6,9–15). Inaccurate positioning of a stent-graft results in a perigraft leak, and once misplacement occurs, the current stent-graft is not retrievable, and the capability for repositioning is limited (17).

One of the problems encountered during deployment of a stent-graft is the pulsatile aortic blood flow that exerts a force moving it distally and causing to-and-fro movement. This makes accurate positioning more difficult and may result in downstream migration and misplacement. Several techniques have been shown to manage this downstream movement of a stent-graft including use of a stiff guide wire, pharmacologically induced systemic hypotension, rapid deployment, aortic balloon occlusion, and adenosine-induced transient cardiac asystole (5–7,9,11,18,19). Even with these techniques, however, this problem has not been completely overcome. The purpose of this study was to evaluate the efficacy of a technique to control aortic blood flow during deployment of an endovascular aortic stent-graft by temporarily occluding the inferior vena cava (IVC) and the superior vena cava (SVC) (20) in the experimental study and the preliminary clinical experience.


   Materials and Methods
TOP
 Abstract
 Introduction
 Materials and Methods
Results
 Discussion
 References
 
Experimental Study
An in vivo experiment for hemodynamic evaluation during and after temporary vena caval occlusion was performed in a mongrel dog that weighed 20 kg. Anesthesia was induced in the animal with ketamine hydrochloride intramuscularly and pentobarbital sodium intravenously. An endotracheal tube was then placed to administer inhalational anesthesia and mechanical ventilation with 1.0%–1.5% halothane during the surgery. Cannulation procedures to the SVC and the thoracic descending aorta for pressure monitoring were performed by means of a right external jugular venotomy and a right femoral arteriotomy, respectively. The SVC and the IVC were isolated through an anterior thoracotomy, and two loop snares were placed at the proximity of each vena cava for temporary occlusion. With use of systemic heparin, both vena cavae were occluded by tightening the loop snare first at the IVC and then, about 10 seconds later, at the SVC. Caval occlusion was maintained for 30 seconds and 1-, 2-, and 5-minute periods separated by short intervals. To reopen the cava, the loop snare at the SVC and then at the IVC was released.

Hemodynamic monitoring at the ascending aorta, left common carotid artery, and anterior descending branch of the left coronary artery was performed with a volume flow meter (Transonic Systems, Ithaca, NY). Cerebral blood flow was evaluated with the needle probe of a laser flow meter (Advance, Tokyo, Japan) inserted through a burr hole created on the left frontal skull. The animal was cared for in compliance with the institutional guidelines for laboratory animal care.

The laboratory experiment was performed by using external vena caval ligatures instead of our planned clinical approach, balloon occlusion. A balloon would be more difficult to position and stabilize, and there would be potential concern that the SVC balloon might be pushed into the atrium once it was inflated.

Clinical Evaluation
From September 1996 to August 1998, 18 patients (12 men and six women; mean age, 74 years; age range, 64–81 years) underwent endovascular stent-graft placement for thoracic (n = 9) and abdominal (n = 9) aortic aneurysms. The mean diameter of the aneurysms was 69.6 mm (range, 45–108 mm). Patient selection for endovascular procedures was based on the morphologic characteristics of the aneurysm and the patient's general health condition. The health of all 18 patients was regarded as unfit for open surgical repair owing to the presence of severe coronary artery disease, cardiopulmonary dysfunction, cerebrovascular disease, multiple previous surgeries, or poor general condition. Informed consent was obtained from each patient after the nature of the procedure was fully explained, and the procedures were approved by the institutional ethics committee.

Custom-designed self-expandable stent-grafts composed of Z stents connected in tandem and covered with low-porosity woven polyester (Ube Kosan, Yamaguchi, Japan) or expanded polytetrafluoroethylene (PTFE; WL Gore and Associates, Flagstaff, Ariz) were used. Straight grafts were implanted in seven thoracic and seven abdominal aortic aneurysms, tapered grafts were used in two thoracic and one abdominal aortic aneurysm, and a bifurcated graft was used in one abdominal aortic aneurysm. The mean diameter of the stent-grafts was 27.5 mm (range, 20–35 mm), and the mean length was 13.8 cm (range, 9–20 cm). Stent-graft placement was performed with general anesthesia in all but one patient.

The stent-graft was advanced through a 20-F Teflon sheath (Cook, Bloomington, Ind) introduced via the cutdown for a femoral artery and was deployed by withdrawing the sheath while holding the pusher rod. When the stent-graft was thought to have not fully opened on the basis of findings at postimplantation angiography, intravascular ultrasonography, or both, gentle dilation of the stent-graft was performed with a balloon catheter (Boston Scientific, Boston, Mass). In two patients with both thoracic and abdominal aortic aneurysms, concomitant abdominal aneurysmectomy was performed before thoracic stent-graft placement, and the thoracic stent-graft was then placed through a 10-mm-diameter side limb sewn on the abdominal aortic graft.

To control aortic blood flow during deployment of the stent-graft, vena caval occlusion was used in the last five patients with thoracic aortic aneurysm. Earlier, systemic hypotension was used in 11 patients with four thoracic and seven abdominal aortic aneurysms, and aortic balloon occlusion was used in one patient with abdominal aortic aneurysm. Blood flow control was not used in the first two patients with abdominal aortic aneurysm.

For temporary vena caval occlusion, the femoral vein surface was dissected in the same field as the femoral arteriotomy, and two 9-F, 25-cm-long angiographic sheaths (Medikit, Tokyo, Japan) were inserted into the IVC. With fluoroscopic guidance, a 5-F multipurpose catheter was introduced through the sheath and maneuvered into the right internal jugular vein by using a guide wire with an angled floppy tip (Terumo, Tokyo, Japan). The catheter and guide wire were gently manipulated to negotiate the venous valves between the brachiocephalic vein and internal jugular vein, and then the floppy guide wire was exchanged for a 0.035-inch extra-stiff guide wire (Cook). After two stiff guide wires were placed through each 9-F sheath, two occlusion balloon catheters with a maximum balloon diameter of 30 mm (Miyano Medical, Tokyo, Japan) were advanced over the stiff guide wires, and each balloon was positioned at the SVC and at the IVC (above the confluence of the hepatic veins). A 20-mL plastic syringe filled with carbon dioxide gas was connected to the stopcock of each occlusion balloon.

When heparin had been administered to the patient and the stent-graft was ready to deploy, the balloon in the IVC was inflated first and then the SVC balloon. The systemic blood pressure decreased, and the stent-graft was deployed in the aorta (Fig 1). The shafts of the balloon catheters were held by the assistant (N.N.) during inflation, and mild traction was applied to the lower balloon catheter to wedge the balloon in the IVC and sufficiently occlude it. After the stent-graft was deployed, first the SVC balloon and then the IVC balloon was deflated. The procedure was performed with general anesthesia and continuous monitoring of the arterial and central venous pressures. A pigtail catheter placed in the thoracic aorta via the brachial artery was used for aortic pressure monitoring.



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  		Figure 1. Schematic depicts temporary balloon occlusion of the vena cava during deployment of an aortic stent-graft. By using stiff guide wires, one occlusion balloon catheter is placed at the SVC, and another is placed at the IVC. The balloons are inflated with carbon dioxide just before and during stent-graft deployment.

 
Systemic hypotension was induced in 11 patients by increasing the depth of anesthesia or administering hyperventilation or intravenous antihypertensive agent, and the mean arterial blood pressure was decreased to 50–60 mm Hg. In one case of abdominal aortic aneurysm, an occlusion balloon catheter with a maximum balloon diameter of 25 mm (Miyano Medical) was introduced into the descending thoracic aorta via the left brachial artery through a 7.5-F, 45-cm-long sheath for temporary aortic occlusion.

To evaluate the effectiveness of the flow-control methods in preventing the downstream movement of a stent-graft during deployment, the videotape of each procedure was reviewed. The distance between the initial and final positions of the proximal end of the stent-graft was measured on the computer monitor by one author (T. Ishiguchi) by using software installed in the angiographic equipment. The initial position was marked when the first segment of the Z stents opened and its topmost end touched the aortic wall. The final position was marked when the stent-graft was completely deployed. The stent-graft has a skeleton of zig-zag wire (Z stents connected in tandem), and it opens from top to bottom by withdrawing the sheath. When the top end (first segment of the connected Z stents) opened first in a funnel shape and it touched the aortic wall, the graft began to be pushed downward by blood pressure, and the position of the stent-graft could change before deployment was complete.


   Results
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
Discussion
 References
 
Experimental Study
After the IVC and SVC occlusion in the animal model, the mean aortic pressure decreased by 62% (from 95 mm Hg before occlusion to 36 mm Hg). The pulse pressure, the difference between the systolic and diastolic pressures, decreased by 74% (from 38 to 10 mm Hg). The aortic blood flow decreased markedly by 90% (from 1.0 to 0.1 L/min), and the common carotid arterial flow and the cerebral blood flow decreased by 85% (from 55 to 8 mL/min and 27 to 4 mL/min per 100 g, respectively). Flow in the left descending coronary artery decreased by 55% (from 10.0 to 4.5 mL/min). The mean central venous pressure measured at the SVC distal to the occlusion did not change markedly (8 mm Hg). After the vena cava was reopened, the parameters promptly returned to the preocclusion levels. The trends of the hemodynamic parameters before, during, and after vena caval occlusion are shown in Figure 2. The coronary arterial flow increased transiently immediately after the IVC occlusion was released and gradually returned to the preocclusion level in 2–3 minutes. These hemodynamic changes were reproducible during repeated occlusions for as long as 5 minutes. There was no change in the cardiac rhythm, and no adverse reaction was seen at anytime during the procedure.



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  		Figure 2. Multichannel recorder image shows trends in the hemodynamic parameters before, during, and after vena caval occlusion in the animal model. Arrows indicate the periods of occlusion of the IVC and the SVC (complete occlusion time, 2 minutes). AoF = aortic blood flow, AoP = aortic pressure, CaF = carotid arterial blood flow, CoF = coronary arterial blood flow.

 
Clinical Evaluation
Placement of the balloon catheters and occlusion at the inferior and the superior vena cavae were performed without difficulty. Balloons inflated with carbon dioxide could be fairly well identified with fluoroscopy (Fig 3). To-and-fro movement of the stent-graft was almost negligible and facilitated precise deployment. Mean occlusion time of the vena cava was 46 seconds (range, 37–50 seconds). In three patients, the stent-graft was dilated after deployment with use of vena caval occlusion. To-and-fro movement of the dilation balloon was subtle and easy to control. The hemodynamic data of the patients during vena caval occlusion showed good agreement with the results obtained in the experimental studies (Fig 4).



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  		Figure 3a. (a, b) Left anterior oblique videotape images were obtained just before stent-graft deployment in a patient with a thoracic aortic aneurysm. Balloons (arrows) in the (a) IVC and (b) SVC are inflated with carbon dioxide. In b, the aortic arch (black arrowheads), the trachea, and the left main bronchus (white arrowheads) are seen.

 


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  		Figure 3b. (a, b) Left anterior oblique videotape images were obtained just before stent-graft deployment in a patient with a thoracic aortic aneurysm. Balloons (arrows) in the (a) IVC and (b) SVC are inflated with carbon dioxide. In b, the aortic arch (black arrowheads), the trachea, and the left main bronchus (white arrowheads) are seen.

 


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  		Figure 4. Multichannel recorder image depicts hemodynamic data of a patient with a thoracic aortic aneurysm. Data were obtained before (left), during (middle), and just after (right) vena caval occlusion. AoP = ascending aortic pressure, BAP = brachial arterial pressure, CVP = central venous pressure (measured at the superior vena cava distal to the occlusion balloon), ECG = electrocardiogram.

 
During balloon inflation, the mean aortic pressure decreased to 50–60 mm Hg, and the pulse pressure decreased to 20–30 mm Hg. The central venous pressure and electrocardiogram did not show any notable change. The venous pressure was also monitored at the right internal jugular vein by using a sheath of the central venous pressure catheter, which showed a mild increase of 3–6 mm Hg. There was no downstream shift of the stent-graft deployed in the thoracic aorta in four of the five patients with stent-grafts placed during vena caval occlusion, and the shift was 2 mm in the remaining patient (mean, 0.4 mm ± 0.9 [SD]). In contrast, downstream shift was 263 mm (mean, 13.7 mm ± 18.2) in 11 of the 11 patients with stent-grafts placed during systemic hypotension. Differences between the two groups were statistically significant with Mann-Whitney U analysis (P < .05) (Fig 5). In two patients with stent-grafts placed without flow control, the downstream shift was 3 and 5 mm (mean, 4 mm). In one patient with a stent-graft placed during aortic balloon occlusion, downstream shift was not noted.



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  		Figure 5. Graph shows the downstream shift ({circ}) of the aortic stent-graft during deployment in 11 patients with induced systemic hypotension and five patients with vena caval occlusion. • indicates the mean values plus or minus 1 SD. The difference between the two groups was statistically significant (P < .05).

 
The stent-graft was successfully placed in 16 of the 18 patients, and thrombosis of the aneurysm was complete. In one patient with a thoracic aortic aneurysm, the stent-graft migrated 63 mm downward from the initially intended position immediately after deployment despite use of systemic hypotension. A perigraft leak persisted although the second stent-graft was placed proximally. In another patient with an infrarenal abdominal aortic aneurysm with a tortuous distal neck, a persistent distal leak was observed after placement of a straight stent-graft followed by placement of an additional stent-graft. These patients have been followed up for 23 and 19 months, respectively, without aneurysm enlargement. There was no other procedure-related complication, and no patient died.


   Discussion
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
References
 
The problem of stent-graft movement caused by pulsatile aortic blood flow was noted in the initial feasibility studies of endovascular graft placement (2,18,21). Several technical modifications to stent-graft deployment have been directed toward overcoming or controlling this problem. A stiff guide wire is most commonly used to keep the system stable during advancement of the introducer sheath and deployment of the stent-graft (4–6,9,15,21). Just before deployment, systemic hypotension is induced by administering intravenous antihypertensive agents (2,5,9,11,18,21). Rapid deployment of a self-expandable graft has been recommended to minimize the time for the stent-graft to directly receive the aortic blood flow at the funnel-shaped open upper end (2,11). Even with use of a combination of these techniques, deployment of a stent-graft at a precise target can be difficult because of the rapid blood flow, especially in the thoracic aorta (11,20). Theoretically, the antihypertensive agents used for systemic hypotension, commonly nitroglycerin or sodium nitroprusside (5,9,11), will decrease the mean aortic pressure to a greater or lesser degree by reducing peripheral arteriolar resistance. The aortic pulse pressure and the cardiac output, on the other hand, may not be diminished effectively enough to control downstream movement of a stent-graft.

Aortic balloon occlusion above the site of deployment is effective in diminishing the flow, but this requires a segment of nonaneurysmal aorta suitable for occlusion and may have a potential risk of aortic injury in patients with aortic dissection or mycotic aneurysm. Introduction of a large occlusion balloon catheter (balloon diameter, >30 mm) into the thoracic aorta via the brachial artery may be also difficult because of the need for a large sheath (>9 F). Moreover, acute mechanical obstruction of a large amount of aortic blood flow may increase the cardiac afterload.

Transient cardiac asystole induced with adenosine prevents displacement of a stent-graft caused by downstream migration (19). With this method, intravenous administration of adenosine is required in successively increasing doses to the dose needed to induce cardiac asystole for 20 seconds or more, which is predetermined in each patient. Asystole lasts 20–30 seconds and is followed by spontaneous return of sinus rhythm. As a precautionary measure, however, prophylactic insertion of a temporary venous pacemaker is necessary.

The Valsalva maneuver is an alternative to pharmacologically induced hemodynamic interference (22). The anesthesiologist ensures hyperventilation in the patient by means of prolonged inspiration. The venous return to the heart is reduced and the cardiac output and systemic pressure decrease. In our limited experience, however, use of this method alone or in combination with antihypertensive agents has not been entirely successful in ensuring complete control of the downstream movement of the stent-graft in the thoracic aorta.

Use of temporary vena caval occlusion was effective, reversible, and simple without the need for use of any drug, cardiac pacemaker, predetermination test, or special instrument other than ordinary occlusion balloon catheters. Contraindications include the presence of thrombus, stenosis, occlusion, or congenital anomalies at the vena cava and the iliac veins. Patients undergo screening for these conditions in the routine work-up with computed tomography or magnetic resonance imaging.

To eliminate the risk of intracranial venous hypertension, which was one of our theoretic concerns while developing this technique, inflation of the balloons should occur in the following order: the IVC balloon first and then the SVC balloon. Deflation of the balloons should be in the reverse order, namely, the SVC balloon deflated first and then the IVC balloon. The venous pressure monitored at the internal jugular vein or at the SVC distal to the occlusion did not demonstrate an abnormal increase in either the animal models or clinical cases.

The duration of vena caval occlusion was under the control of the radiologist who deployed the stent-graft. The occlusion time was less than 1 minute (mean, 46 seconds) for stent-graft deployment and was much shorter for postdeployment balloon dilation. Although no neurophysiologic parameters (such as those at electroencephalography) were evaluated in the present study, the control of arterial flow within 1 minute appears to be safe. The central nervous system, which contains the tissue most vulnerable to interruption of the circulation and oxygenation, can usually tolerate 4–6 minutes of anoxia due to cardiac arrest at normothermia (23). In our animal studies, no prolonged hemodynamic change was observed with repeated vena caval occlusions for as long as 5 minutes.

During vena caval occlusion in the animal model, the aortic blood flow decreased by 90% with marked decreases in the mean aortic pressure and the pulse pressure, whereas 45% of the coronary flow was preserved. Because vena caval occlusion caused a marked decrease in the cardiac preload, we believe that the myocardial oxygen demand will not be increased. We consider the transient increase in the coronary blood flow immediately after the release of occlusion in the animal model to be related to a rapid increase in the cardiac blood inflow. Although no abnormality was evident at electrocardiography, the physiologic influence and importance of this phenomenon in various clinical situations, including patients with severe ischemic heart disease, is unknown.

Our patients experienced no complication related to the vena caval occlusion. Possible complications of this technique include balloon rupture or migration during inflation. We inflated the balloons with carbon dioxide gas to avoid the loading of excessively high pressure and also to ensure a better response; otherwise, it would take much longer to inflate and deflate each balloon with diluted contrast material. The inflated balloons may move upward in the IVC or downward in the SVC with the venous flow. When the balloon is moved into the right atrium, it may cause incomplete occlusion or arrhythmia. To prevent this, the stiff guide wires placed into the internal jugular vein were used to support the balloon catheters. During inflation, we also recommended that the shafts of the balloon catheters be held by the assistant or fixed with a suture at the patient's groin.

Because the vena caval occlusion is independent of aortic catheterization, this technique is widely applicable with any stent-graft system to treat thoracic and abdominal aortic aneurysms. With this technique in the present study, the accuracy of stent-graft placement in thoracic aortic aneurysms was 0–2 mm (mean, 0.4 mm). These results support the application of this technique in patients with more difficult disease, especially when precise placement of the stent-graft is necessary (eg, near the left subclavian, celiac, or renal arteries).

From our limited experience, temporary vena caval occlusion appears to be safe, technically feasible, and effective for precise deployment of aortic stent-grafts. Further studies are needed to determine the efficacy of this technique to improve therapeutic results and expand the application of endovascular treatment for aortic aneurysms and other pathologic conditions including dissection or fistula.


   Footnotes
 
Abbreviations: IVC = inferior vena cava SVC = superior vena cava

Author contributions: Guarantors of integrity of entire study, T. Ishiguchi, T. Ishigaki; study concepts and design, T. Ishiguchi, N.N., A.U.; definition of intellectual content, T. Ishiguchi, N.N.; literature research, T. Ishiguchi; clinical studies, T. Ishiguchi, N.N.; experimental studies, T. Ishiguchi, N.N., A.U.; data acquisition, T. Ishiguchi, N.N., A.U.; data analysis, T. Ishiguchi; manuscript preparation and editing, T. Ishiguchi; manuscript review, N.N., A.U., T. Ishigaki.


   References
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 

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