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Can Aortic Balloon Occlusion Reduce Blood Loss During Resection of Sacral Tumors That Extend Into the Lower Lumber Spine?

Zhang, Yidan MD; Guo, Wei MD, PhD; Tang, Xiaodong MD; Yang, Rongli MD; Yan, Taiqiang MD; Dong, Sen MD; Wang, Shidong MD; Zaphiros, Nikolas MD

Clinical Orthopaedics and Related Research®: March 2018 - Volume 476 - Issue 3 - p 490–498
doi: 10.1007/s11999.0000000000000053
2016 MUSCULOSKELETAL TUMOR SOCIETY PROCEEDINGS
Free

Background Although aortic balloon occlusion has been shown to reduce blood loss during sacral tumor resections, it has not been validated in larger sacral tumors involving the lower lumbar spine. If such an approach were shown to be associated with less blood loss, it might aid the tumor surgeon in resecting these difficult tumors.

Questions/purposes (1) Is the use of aortic balloon occlusion associated with reduced blood loss in sacral tumor resections when the lower lumbar spine is also involved? (2) Does the use of the aortic balloon prolong total operating time? (3) What complications are associated with the use of a balloon?

Methods We retrospectively studied all 56 patients diagnosed with sacral tumors involving the lower lumbar spine (L4, L5) who were treated surgically between 2004 and 2015 at our institute. During that time, 30 of the patients received aortic balloon occlusion therapy, whereas 26 of the patients did not. We generally used aortic balloon occlusion during procedures for hypervascular lesions (for example, giant cell tumors or metastatic renal cancers), primary malignant lesions, and recurrent lesions. We generally avoided use of aortic balloon occlusion in patients with anatomic defects of the aorta (aortic dissection or aneurysm was strictly contraindicated), renal artery bifurcation caudal to the L2 to L3 disc, age older than 70 years or younger than 12 years, history of Stage 2 hypertension [9], history of balloon use in previous surgeries, and presence of unstable plaque on abdominal CT. The demographic data, intraoperative blood loss, transfusion volume, operating time, and postoperative wound drainage between the two groups were collected and analyzed. Balloon-related complications were identified. Followup in terms of balloon-related complications was conducted in all 56 patients for at least 6 months after surgery.

Results Intraoperative blood loss was determined to be less in patients treated with the balloon compared with those treated without the balloon (median volume, 2000 mL, range, 400-6000 mL versus 2650 mL, range, 550-6800 mL, respectively; median difference, 605 mL; 95% confidence interval [CI], 100-1500 mL; p = 0.035). Total operative time was not prolonged in the balloon group (including balloon insertion time) compared with those treated without it (median time, 215 minutes, range, 110-430 minutes versus 225 minutes, range, 115-340 minutes, respectively; median difference, 10 minutes; 95% CI, -40 to 30 minutes; p = 0.902). Balloon-related vascular complications included local hematoma at the puncture site in five patients, femoral artery spasm in three patients, lower limb ischemia in one patient, and femoral artery pseudoaneurysm in one patient. Acute kidney injury was found in two patients in the balloon group.

Conclusions This study demonstrated that placement of the aortic balloon at a level just caudal to the renal artery bifurcation was associated with lower intraoperative blood loss and transfusion in lumbosacral tumor resections. However, procedure-specific complications were common and there was no benefit to total operative time. We suggest that the surgical procedures still need to be further refined to minimize complications. We also recommend that prospective studies be undertaken to confirm the efficacy of aortic balloon occlusion in surgery for lumbosacral tumors.

Level of Evidence: Level III, therapeutic study.

Y. Zhang, W. Guo, X. Tang, R. Yang, T. Yan, S. Dong, S. Wang Musculoskeletal Tumor Center, Beijing Key Laboratory for Musculoskeletal Tumors, Peking University People's Hospital, Beijing, China

N. Zaphiros Department of Orthopaedic Surgery, Montefiore Medical Center and The Children's Hospital at Montefiore, Bronx, NY, USA

W. Guo Musculoskeletal Tumor Center Beijing Key Laboratory for Musculoskeletal Tumors Peking University People's Hospital 11 Xizhimen S Street Xicheng, Beijing, China 100044 email: bonetumor@163.com

Each author certifies that neither he or she, nor any member of his or her immediate family, have funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article.

All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request.

Clinical Orthopaedics and Related Research® neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA-approval status, of any drug or device prior to clinical use.

Each author certifies that his or her institution approved or waived approval for the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research.

This work was performed at the Musculoskeletal Tumor Center, Beijing Key Laboratory for Musculoskeletal Tumors, Peking University People's Hospital, Beijing, China.

Received August 01, 2016

Received in revised form April 01, 2017

Accepted November 13, 2017

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Introduction

Sacral tumors have an insidious onset and in some cases may invade the lower lumbar spine before symptoms occur [2, 4, 23, 28]. Patients with sacral tumors cephalad to the S2 to S3 disc space are at risk for larger volumes of blood loss during resection [25]. Thus, massive sacral tumors invading the lower lumbar spine are presumably riskier to treat operatively as a result of the complex anatomy surrounding the lumbar vertebrae [14]. Once a primary malignant tumor involves the L4 to L5 spinal vertebrae, it is challenging for surgeons to perform en bloc resection and to obtain clear margins, which is needed to assure a better oncologic result [28]. Even when performing debulking operations for metastatic tumors, surgeons may encounter severe bleeding [1].

Abdominal aortic balloon occlusion has been successfully implemented in controlling bleeding in sacropelvic resections [10, 14, 15, 26, 33]. Because most sacral tumors receive a blood supply from the iliolumbar arteries and the lateral sacral arteries originating from the internal iliac artery, by placing the aortic balloon cephalad to the iliac bifurcation and inflating it to an expected pressure, blood flow to the sacral tumor can be minimized [29]. However, it has not been shown whether an aortic balloon can decrease blood loss in the presence of lower lumbar spine tumor invasion and whether such a balloon would also decrease blood flow to the collateral segmental lumbar arteries, which supply blood to the tumor.

We therefore asked: (1) Is the use of aortic balloon occlusion associated with reduced blood loss in sacral tumor resections when the lower lumbar spine is also involved? (2) Does the use of the aortic balloon prolong total operative time? (3) What complications are associated with the use of a balloon?

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Patients and Methods

We performed a retrospective study at our institute with approval from the institutional review board. From 2004 to 2015, we surgically treated 56 patients for sacral tumors involving the lower lumbar spine (L4, L5) at our institute. All of the patients were evaluated in the current study. Abdominal aortic balloon occlusion was used intraoperatively in 30 patients while the remaining 26 patients in whom the procedure was not conducted served as the control group. All of the tumors in this study consistently had bony invasion to the sacrum and the lower lumbar spine. Partial or total sacrectomy along with resection of the involved lower lumbar spine was routinely performed. All patients with primary malignant tumors and solitary metastatic bone tumors underwent en bloc resection with the aim of achieving adequate margins. For most benign tumors and other metastatic bone tumors, intralesional resection or curettage was preferred depending on the histologic type. Pure soft tissue tumors localized in the lumbosacral region were not evaluated in this study.

During the period noted, we generally used aortic balloon occlusion during procedures for hypervascular lesions (for example, giant cell tumors or metastatic renal cancers), primary malignant lesions, and recurrent lesions. We avoided use of aortic balloon occlusion in patients with anatomic defects of the aorta (aortic dissection or aneurysm was strictly contraindicated), renal artery bifurcation caudal to the L2 to L3 disc, age older than 70 or younger than 12 years, history of Stage 2 hypertension, history of balloon use in previous surgeries, and presence of unstable plaque on abdominal CT. These indications and contraindications were applied consistently by the four surgeons whose patients were included in this report (WG, XT, RY, TY). Furthermore, we prioritized the contraindications over the indications for safety reasons.

The Coda® balloon catheter (Cook Medical, Bloomington, IN, USA) was generally used, whereas the MAXI LD™ balloon catheter (Cordis, Baar, Switzerland), which has a stiffened balloon wall, was used in patients older than 55 years of age to prevent balloon overinflation and to minimize injuries to the atherosclerotic aorta. The catheter was introduced through a 12-Fr sheath as previously described [26]. In our experience, balloon positioning and the desired balloon pressure should be obtained in three steps. First, the balloon is filled with the injected contrast and determined to be stable at the level just caudal to the renal artery bifurcation (Fig. 1). Second, angiography of the proximal aorta should show abundant blood flow within both renal arteries after the balloon is inflated. Third, the angiogram should show no blood flow in the L3 to L5 lumbar arteries and the distal aorta (Fig. 2). Constant intraoperative monitoring of the distal arterial pressure and urine volume is obligatory and critical to ensure the balloon is working properly.

Fig. 1

Fig. 1

Fig. 2

Fig. 2

Medical charts of all patients were reviewed through the electronic hospital information system by the study coordinator (YS). Primary lesions accounted for 83% and 77% of cases in the balloon and nonballoon groups, respectively (Table 1). Both groups were comparable in terms of patients’ age, gender, location of tumor, type of tumor, history of recurrence, and type of resection (Table 2). The outcomes we compared in this study included intraoperative blood loss, amount of blood transfusion, operative time, and postoperative wound drainage (Table 3). There was no difference between the two groups in achieving surgical margins for primary malignant lesions. No patient was lost to followup for at least 6 months after surgery with a median followup of 38 months (range, 7-106 months) in the balloon group and 43 months (range, 9-127 months) in the nonballoon group.

Table 1

Table 1

Table 2

Table 2

Table 3

Table 3

In the intervention group in which aortic balloon occlusion was applied, the diagnoses consisted of 13 primary benign tumors, 12 primary malignant tumors, and five metastatic carcinomas. Nineteen of 30 patients had lower lumbar spine involvement to the level of the L5 vertebra, seven patients were affected to the level of L4, whereas another four were affected to the level of L3. Among the control group, in which an aortic balloon was not applied, the diagnoses included 14 primary benign tumors, six primary malignant tumors, and six metastatic carcinomas. Eighteen of 26 patients had L5 involvement, five patients were affected to the level of L4, whereas another three were affected to the level of L3. Of the six patients with primary malignant tumors in the control group, three patients had Stage 2 hypertension, one patient had a tortuous aorta, one patient was younger than 12 years old, and one patient had a history of aortic occlusion during previous surgery. Of the seven patients with giant cell tumors in the control group, five patients had Stage 2 hypertension, one patient had low renal artery bifurcation, and one patient had unstable aortic plaque.

Of the 30 patients in the intervention group, 11 were considered to have a high risk for perioperative bleeding as a result of a history of recurrent malignancy. Of the 26 patients in the control group, five were recurrent cases. Among these five patients, three patients had Stage 2 hypertension and two patients had balloon occlusion in previous surgeries. In general, transfusion was considered when hemoglobin was or was estimated to be < 8 g/dL.

The intraoperative blood loss was estimated by the sum of the volume of mechanical suction and absorption of dressings and sponges. The need for blood transfusion was determined by assessing the hemodynamic status of the patient; anesthesiologists monitored intraoperative blood pressure, pulse rate, and hemoglobin values.

Unlike the control group in which operating time is recorded from incision to wound closure, the start time for the balloon group was recorded from the moment of balloon insertion, which is done before incision. The postoperative drainage volume was recorded by nurses at the end of the first 12 hours after surgery. The perioperative complications were collected from the patients’ records and the late balloon-related complications including aortic aneurysms and renal dysfunctions were evaluated by abdominal CT scan and a blood creatinine test, respectively, at the time of followup until 6 months after surgery.

An independent t-test was used to compare the mean age between the two groups. Pearson’s chi square test and Fisher’s exact test were performed to compare the demographic data including gender, location of the tumor, type of tumor, etc. A Mann-Whitney U test was applied to compare clinical outcomes, including intraoperative blood loss, operating time, volume of transfusion, and postoperative wound drainage. The level of significance was p < 0.05. Statistical analyses were conducted using IBM SPSS Statistics 22.0 (IBM, Armonk, NY, USA) and GraphPad Prism 7.02 (GraphPad, La Jolla, CA, USA).

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Results

The implementation of aortic balloon occlusion was associated with lower median intraoperative blood loss in surgery of sacral tumors involving the lower lumbar spine (2000 mL, range, 400-6000 mL versus 2650 mL, range, 550-6800 mL, respectively; median difference, 605 mL; 95% confidence interval [CI], 100-1500 mL; p = 0.035) (Table 3). Median volumes of blood product transfusion and packed red blood cells were lower with the application of balloon occlusion, from 2300 mL (range, 400-6000 mL) to 1600 mL (range, 600-5400 mL; median difference, 700 mL; 95% CI, 20-1360; p = 0.029) and from 1200 mL (range, 200-3000 mL) to 800 mL (range, 200-3000 mL; median difference, 400 mL; 95% CI 20-760; p = 0.018), respectively.

No difference was found in the total operative time between the two groups (median time, 215 minutes, range, 110-430 minutes for the balloon group versus 225 minutes, range, 115-340 minutes for the control group; median difference, 10 minutes; 95% CI, -40 to 30 minutes; p = 0.902).

Balloon-related vascular complications included local hematoma at the puncture site in five patients, femoral artery spasm in three patients, lower limb ischemia in one patient, and femoral artery pseudoaneurysm in one patient. Hematomas were watched carefully but no further treatment was performed. Femoral artery spasms were all reversible after removal of the catheter sheath. The patient with limb ischemia was treated with embolectomy, resulting in preservation of the limb. One patient who developed a femoral artery pseudoaneurysm at the puncture site 2 weeks after retrieval of the catheter sheath was successfully treated by transarterial thrombin injection and a covered stent, which can repair the damaged vessel with a fabric coating. Two patients were diagnosed with acute kidney injury related to the inappropriate position of the balloon. Both patients recovered after 1 week of hemodialysis and strict fluid and electrolyte monitoring. In addition, delayed postoperative bleeding, defined as excessive wound drainage that required surgical exploration or immediate embolization, occurred in two patients in the balloon group and in one patient in the nonballoon group. All of them were successfully treated by emergent embolization. No complications related to large amounts of blood loss such as ischemic heart disease and cerebral vascular accident were determined in either group. No perioperative mortality was determined in this cohort. No other long-term adverse events such as abdominal aneurysm or chronic renal failure were reported regarding the aortic balloon occlusion.

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Discussion

Massive intraoperative bleeding during sacrectomy is a major challenge for orthopaedic surgeons [27]. Several approaches used to minimize bleeding include absorbable hemostatic agents [8, 30], hemostatic devices [6, 22], hypotensive epidural anesthesia [7], and preoperative arterial embolization [12, 20, 31]. Although embolization is effective in limiting blood flow in major arteries, complications such as gluteal or lumbosacral necrosis may still occur as a result of extensive embolization and irreversible blood supply [5, 24]. The use of an aortic balloon seems promising because it can directly decrease blood flow in the distal aorta [29] while the impact on arterial blood supply to the adjacent normal structures after balloon deflation is minor. However, there have been no studies that have evaluated whether the balloon could still function when sacral tumors extend cranially into the lower lumbar spine. In our study, we found that the aortic balloon occlusion was associated with reduced intraoperative blood loss and transfusion use in lumbosacral tumor resections. Notably, the total operative time (including balloon insertion) was not prolonged compared with the control group. We also found that vascular events were the most common balloon-related complications with acute kidney injury being a newly occurring complication that has not been previously reported.

Our study had some limitations as a result of its retrospective nature. First, the assignment of patients to the balloon and control groups was not random. Patients with potentially higher risks of bleeding were clinically indicated for balloon use. However, some of those patients did not receive balloon occlusion as a result of prioritized contraindications for safety reasons. In effect, the exclusion of those patients allowed for a more normalized distribution of patient characteristics, which makes the two groups of patients more comparable. Second, the variation in anesthetic techniques among anesthesiologists could affect the estimation of bleeding volume and calculation of transfusion volume, which may lead to inevitable observer differences. Third, the two groups are not directly comparable with respect to diagnosis as a result of combined histologic types. In addition, combining primary tumors with metastatic lesions is another limitation of the study, which could be solved by expanding the number of patients and evaluating primary and metastatic tumors separately in future studies. We also had some soft tissue lesions, which further complicates the analysis, but in all instances, there was bony involvement. We included no patients who had soft tissue neoplasms without bony involvement. Lastly, a followup of 6 months may not be sufficient to evaluate long-term balloon-related complications.

In patients who had aortic balloon occlusion, there was an associated reduction in mean intraoperative blood loss, mean volume of blood product transfusion, and mean volume of packed red blood cell transfusion compared with those who did not receive the balloon. Aortic balloon occlusion has been shown to reduce blood loss in a few studies on sacropelvic tumors [10, 15, 17, 26, 29, 32] (Table 4). One study on a large series of 215 patients reported that the mean intraoperative blood loss volume (2236 mL) was lower than that of the patients without occlusions (3935 mL) [26]. Another study of a total of 137 patients demonstrated that use of balloon occlusion reduced intraoperative blood loss and transfusion (678 mL and 351 mL versus 1619 mL and 1106 mL) [15]. In our study, we expanded the indication for an aortic balloon to include tumors extending into the lumbar region of the spine and showed its efficacy in controlling bleeding. According to our observations, iliolumbar arteries arising from the internal iliac arteries, the median sacral artery, collaterals from the external iliac arteries as well as segmental lumbar arteries arising more cephalad from the aorta contribute to the blood supply for sacral-lumbar tumors of the spine. As such, more elaborate and precise positioning of the balloon just caudal to the renal artery bifurcation is a necessity. In this way, the blood flow to multiple pairs of segmental lumbar arteries could be maximally reduced. This preoperative arterial embolization has also been shown to successfully reduce intraoperative blood loss [18]. Importantly, superselective embolization, which is crucial to the optimization of bleeding control, needs to be performed by an experienced interventional radiologist with a high level of expertise in lumbosacral tumor procedures [3, 18, 21]. Furthermore, the cost-effectiveness analysis of the aortic balloon occlusion versus preoperative arterial embolization has not, as of yet, been elucidated.

Table 4

Table 4

As shown in our results, the use of the balloon does not prolong the total operative time of lumbosacral tumor surgery. Because the insertion of the aortic balloon takes approximately 30 minutes, the time required for tumor resection is essentially shortened, which is consistent with previous studies. Previous case-control studies on sacral tumor operations have shown that use of an aortic balloon reduces operative time [15, 26]. Both studies determined a historical group of patients who did not use balloon occlusion as the control. Furthermore, because the balloon is inserted before the operative incision is performed, it might be reasonable to add the insertion time to the operative time, which can more accurately reflect the total operative time in which the patient is under general anesthesia and surgical intervention. According to our understanding, aortic balloon occlusion as well as preoperative embolization [18] could reduce operative time mainly through improving visualization of the operative field and accessibility of lesions. Interestingly, a study revealed that hypotensive epidural anesthesia could reduce blood loss with the added benefit of reducing operative time in pelvic and sacral bone tumor resections [7]. Although the potential risk for adverse events with the use of hypotensive epidural anesthesia remains to be evaluated, it may serve as an alternative approach for patients contraindicated for an aortic balloon.

In our study, complications were common in patients who had the aortic balloon. Minor vascular events including local hematoma and femoral artery spasm occurred in eight (27%) of the 30 patients, which was higher than that (6%) reported in a large series of 911 patients after intraaortic balloon pump treatment [16]. Major vascular events requiring surgical intervention occurred in two (7%) of 30 patients (one femoral artery pseudoaneurysm and one ischemia of a limb), which was comparable to an incidence rate of 9% reported in a prospective study on percutaneous coronary angioplasty [13]. These complications might be related to the use of a thickened 12-Fr sheath leaving a large hole in the artery after retrieval. Some suture-mediated closure devices are available to minimize vascular complications [11]. Aside from the vascular complications at the puncture site, we also identified two patients with postoperative acute kidney injury, which has not been reported as a balloon-related complication in previous studies (Table 4). We suspect that the balloon slid cranially and obstructed at least one side of the renal artery during the position change after insertion. The resulting renal ischemia, in addition to volume insufficiency and adverse drug effects, may have impaired renal function and caused the acute kidney injury. As such, we suggest that an angiogram be performed to identify balloon location after any position changes during the operation. Embolization has a good safety profile in patients with bone tumors in general [12, 18]. However, acute kidney injury, which is induced by contrast rather than renal ischemia, has been mentioned in a previous study of patients with metastatic bone tumors undergoing embolization [19]. Although the overall incidence is low, this severe complication must be considered, especially in patients with preexisting renal impairment, when opting to use embolization. Besides, we also notice that severe complications including gluteal or lumbosacral necrosis could possibly occur if superselective embolization was not achieved [5, 24]. We propose that combining limited preoperative superselective embolization with intraoperative aortic balloon occlusion may potentially optimize their respective efficacies and minimize their complications.

In conclusion, this study demonstrated that placement of the aortic balloon at a level just caudal to the renal artery bifurcation was associated with lower intraoperative blood loss and need for transfusion in lumbosacral tumor resections. However, procedure-specific complications were common and there was no benefit to total operative time. We suggest that the surgical procedures still need to be further refined to minimize complications. We also recommend that prospective studies be undertaken to confirm the efficacy of aortic balloon occlusion in surgery for lumbosacral tumors.

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Acknowledgments

We thank Ms Yanchun She for assistance with data collection.

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