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Title: Percutaneous Endovascular Retrieval of Large Cement Leakage into the Right Atrium Following Cement-Augmented Pedicle Screw Instrumentation Authors: Shinji Takahashi 1 , MD, PhD, Etsuji Sohgawa 2 , MD, Akinobu Suzuki 1 , MD, PhD, Akira Yamamoto 2 , MD, PhD, Ryo Sasaki 1 , MD, Katsuaki Tanaka 3 , MD, PhD, Hidetomi Terai 1 , MD, PhD, Masatoshi Hoshino 1 , MD, PhD, Hiromitsu Toyoda 1 , MD, PhD, Koji Tamai 1 , MD, PhD, Hiroaki Nakamura 1 , MD, PhD Institutional affiliations 1. Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine, Osaka, Japan 2. Department of Diagnostic and Interventional Radiology, Osaka City University Graduate School of Medicine, Osaka, Japan 3. Department of Anesthesiology, Osaka City University Graduate School of Medicine, Osaka, Japan Corresponding author: Shinji Takahashi Email: [email protected] Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine Address: 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan Tel: +81-6-6645-3851 Fax: +81-6-6646-6260 Conflicts of interest: The authors declare that there are no relevant conflicts of interest. Author contributions: Shinji Takahashi, Akinobu Suzuki, and Ryo Sasaki treated this patient, collected the data, and drafted this report. Etsuji Sohgawa, Akira Yamamoto, and Katsuaki Tanaka treated this patient Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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Page 1: Spine Surgery and Related Research

Title:

Percutaneous Endovascular Retrieval of Large Cement Leakage into the Right Atrium Following

Cement-Augmented Pedicle Screw Instrumentation

Authors:

Shinji Takahashi1, MD, PhD, Etsuji Sohgawa2, MD, Akinobu Suzuki1, MD, PhD, Akira

Yamamoto2, MD, PhD, Ryo Sasaki1, MD, Katsuaki Tanaka3, MD, PhD, Hidetomi Terai1, MD,

PhD, Masatoshi Hoshino1, MD, PhD, Hiromitsu Toyoda1, MD, PhD, Koji Tamai1, MD, PhD,

Hiroaki Nakamura1, MD, PhD

Institutional affiliations

1. Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine,

Osaka, Japan

2. Department of Diagnostic and Interventional Radiology, Osaka City University Graduate

School of Medicine, Osaka, Japan

3. Department of Anesthesiology, Osaka City University Graduate School of Medicine, Osaka,

Japan

Corresponding author: Shinji Takahashi

Email: [email protected]

Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine

Address: 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan

Tel: +81-6-6645-3851

Fax: +81-6-6646-6260

Conflicts of interest:

The authors declare that there are no relevant conflicts of interest.

Author contributions:

Shinji Takahashi, Akinobu Suzuki, and Ryo Sasaki treated this patient, collected the data, and

drafted this report. Etsuji Sohgawa, Akira Yamamoto, and Katsuaki Tanaka treated this patient

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Page 2: Spine Surgery and Related Research

and collected the data. Hidetomi Terai, Masatoshi Hoshino, Hiromitsu Toyoda, Koji Tamai, and

Hiroaki Nakamura revised the drafted paper. All authors approved the final version for

publication.

Sources of financial support: None

IRB approval: This study was approved by the Institutional Review Board of Osaka City

University (No. 3170).

Acknowledgments: None

Informed consent: The patient provided informed consent for the publication of their case.

Key words: osteoporosis, cement leakage, percutaneous endovascular retrieval, cement-

augmented pedicle screw instrumentation, inferior vena cava, vertebral fracture

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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1 Percutaneous Endovascular Retrieval of Large Cement Leakage into the Right

2 Atrium Following Cement-Augmented Pedicle Screw Instrumentation

3

4 Spinal deformities in patients with osteoporosis are difficult to treat because of their

5 debilitating and progressive nature.1 Such cases often necessitate spinal instrumentation

6 to reduce the back pain or neurological deficit. However, a pedicle screw in the

7 osteoporotic spine poses an increased risk of screw loosening, pullout, and fixation

8 failure. A cement-augmented fenestrated pedicle screw (CAPS) overcomes these

9 problems by improving the initial fixation strength and fatigue strength of

10 instrumentation in osteoporotic vertebrae and offers significant pullout strength.2

11 However, there are several reports of intravascular cement leakage.3 We encountered a

12 case of intravascular long cement leakage following CAPS.

13 Vertebral column resection (VCR) was planned for a 78-year-old female with

14 osteoporotic vertebral fracture at T12 (Fig 1). The use of CAPS was considered because

15 pedicle screw loosening before surgery was a concern. Pedicle screws were inserted at

16 the T10, T11, L1, and L2 pedicles under fluoroscopy. Expedium Verse® spinal system

17 and Vertecem V+® cement (DePuy Synthes Products, Inc., Raynham, MA, USA) were

18 used. After 4 minutes of mixing, the bone cement was inserted into T10 pedicle screws.

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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19 A couple of minutes later, the bone cement was inserted into L2. At this point, we

20 observed long bone cement leakage from the L2 pedicle in fluoroscopy (Fig 2A), into

21 the vein (Fig 2B). The cement gradually moved to the cranial side and stopped at the

22 level of the heart, requiring stoppage of the surgery. At this time, there was no change in

23 blood pressure, heart rate, and electrocardiogram. We consulted a radiologist

24 responsible for the endovascular therapy. Simultaneously, heparin was administered to

25 prevent the formation of thrombosis around the foreign body and subsequent pulmonary

26 artery embolization. Transesophageal echocardiography showed that the migrated

27 cement reached into the right atrium and touched the interatrial septum (Fig 2C). We

28 planned to remove the free cement fragment using a catheter immediately after VCR to

29 avoid the risk of heart wall perforation. The postoperative x-ray showed the migrated

30 cement (Fig 2D and 2E).

31 The patient was moved from the prone position to the supine position. First, a 16F

32 sheath (Gore® DrySeal, 33 cm) was positioned in the inferior vena cava via the right

33 femoral vein under ultrasound guidance. The retrieval catheter (Merit Medical ™

34 EnSnare® system, 6F) was introduced into the right atrium under fluoroscopic guidance

35 with general anesthesia continued. We successfully captured the migrated cement linear

36 fragment using a triple-loop snare (Fig 3A and B). The object was long (6.5 cm) and

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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37 had a needle-like appearance (Fig 3C). Contrast-enhanced CT taken after surgery

38 revealed no evidence of pulmonary embolism and cardiac perforation. The patient’s

39 back pain was relieved after surgery, and no further complications occurred.

40 When used at low viscosity of the bone cement for CAPS, the cement poses a risk

41 of leakage into the venous system.4 Janssen et al.5 investigated 165 patients who

42 underwent spine surgery with CAPS. They identified 68 cases with cement leakage into

43 paravertebral veins or the ascending vena cava and 13 patients with pulmonary cement

44 embolism (7.9%), of whom five (3.0%) were symptomatic. In addition, a case of cardiac

45 perforation caused by bone cement, closely resembling our situation, was reported as a

46 complication of CAPS,6 wherein the authors reported the presence of a sharp and large

47 fragment (4.5-cm-sized and needle-shaped). In their case, the authors detected cement

48 leakage 7 days after spine surgery and performed anterolateral thoracotomy under

49 one-lung ventilation for its removal. In our case, the leakage was spotted during the

50 VCR, and therefore an immediate retrieval procedure using a percutaneous

51 endovascular approach could be planned. Since a linear-shaped cement fragment was

52 fragile to catch by endovascular devices, it was useful to introduce a large bore sheath

53 and use of triple-loop retrieval kits, which were designed with the rigor of inferior vena

54 cava filter retrieval (Fig 3D and 3E). To our knowledge, there have been no studies to

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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55 reveal an effective way for the prevention or prediction of cement leakage. A strict

56 indication for CAPS should be necessary to minimize the risk. In addition, CAPS

57 should be used carefully, especially in patients with contraindications for

58 anticoagulation and endovascular treatment.

59

60 References

61 1. Ponnusamy KE, Iyer S, Gupta G, et al. Instrumentation of the osteoporotic spine:

62 Biomechanical and clinical considerations. Spine J. 2011;11(1): 54-63.

63 2. Burval DJ, McLain RF, Milks R, et al. Primary pedicle screw augmentation in

64 osteoporotic lumbar vertebrae: Biomechanical analysis of pedicle fixation

65 strength. Spine (Phila Pa 1976) 2007;32(10): 1077-83.

66 3. Singh V, Mahajan R, Das K, et al. Surgical trend analysis for use of cement

67 augmented pedicle screws in osteoporosis of spine: A systematic review (2000–

68 2017). Glob Spine J. 2019;9(7): 783-95.

69 4. Bohner M, Gasser B, Baroud G, et al. Theoretical and experimental model to

70 describe the injection of a polymethylmethacrylate cement into a porous structure.

71 Biomaterials. 2003;24(16): 2721-30.

72 5. Janssen I, Ryang YM, Gempt J, et al. Risk of cement leakage and pulmonary

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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73 embolism by bone cement-augmented pedicle screw fixation of the

74 thoracolumbar spine. Spine J. 2017;17(6): 837-44.

75 6. Hong SW, Oh T-H, Jeon JM, et al. Cardiac perforation caused by bone cements

76 as a complication of cement augmented pedicle screw fixation using the

77 fenestrated pedicle screw: A case report. Korean J Neurotrauma. 2020;16(2):

78 337.

79

8081

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82 Figure legends

83

84 Figure 1. A 78-year-old female with an osteoporotic vertebral fracture at T12 presented

85 severe back pain.

86

87 Figure 2. Bone cement leakage (yellow arrow) from the L2 pedicle was observed in the

88 lateral view of fluoroscopy (A). Cement leakage (on the right side) into the inferior vena

89 cava (B). Transesophageal echocardiography showed that the migrated cement reached

90 into the right atrium and touched the interatrial septum (C). The post-VCR x-ray

91 showed the migrated cement at heart level (D, E).

92 Abbreviations: IVC, inferior vena cava; RA, right atrium; SVC, superior vena cava

93

94 Figure 3. The migrated cement body (yellow arrow) was captured using a triple-loop

95 snare (white arrow) (A, B). The retrieved object was large (6.5 cm) and had a

96 needle-like appearance (C). Triple-loop retrieval kits, which were designed with the

97 rigor of inferior vena cava filter retrieval, were used (D, E).

98

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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Figure 1.

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Page 10: Spine Surgery and Related Research

Figure 2.

(A)

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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(B)

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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(C)

IVC

SVC

RA

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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(D)

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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(E)

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Page 15: Spine Surgery and Related Research

Figure 3. (A)

(B)

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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(C)

(D)

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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(E)

Spine Surgery and Related Research J-STAGE Advance Publication (March 10, 2021) Ⓒ The Japanese Society for Spine Surgery and Related Research. CC BY-NC-ND 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/).