11 Balloon Kyphoplasty



10.1055/b-0040-175460

11 Balloon Kyphoplasty

James Mooney, John W. Amburgy, D. Mitchell Self, Leah J. Schoel, and M.R. Chambers


Summary


Balloon kyphoplasty is a minimally invasive vertebral augmentation procedure used to treat painful vertebral compression fractures. The goal of any vertebral augmentation procedure is pain reduction, stabilization of the fracture, and improvement in patient function. Unique to balloon kyphoplasty is restoration of vertebral body height and reduction of kyphotic angulation through the use of inflatable bone tamps. In addition, the balloon tamps reduce the risk of cement leakage by facilitating an injection that follows the path of least resistance into and around the cavity created by the balloon. In this chapter, the diagnostic criteria, techniques, indications, and contraindications are discussed. Materials, equipment, imaging, and the procedure itself are described in detail. In addition, the importance of sagittal balance restoration and realignment is addressed as it relates to the risk of adjacent fractures. The risks and benefits of balloon kyphoplasty are summarized.




11.1 Introduction


Vertebral augmentation is a category of surgical procedures used to treat vertebral fractures and includes vertebroplasty, kyphoplasty, and implants. The goal of any vertebral augmentation procedure is the minimally invasive reduction and stabilization of a painful vertebral compression fracture (VCF). Unique to balloon kyphoplasty is restoration of vertebral body height and reduction of kyphotic angulation through the use of inflatable bone tamps. The balloon tamps reduce the risk of cement leakage by facilitating an injection that follows the path of least resistance into and around the cavity created by the balloon.



11.2 Materials


The surgical equipment is available through numerous sources. A comprehensive list of manufacturers, materials, and equipment for kyphoplasty can be found in ▶Table 11.1. Components available from Medtronic Kyphon are listed in the following sections and shown in ▶Fig. 11.1.

Fig. 11.1 Kyphon Balloon Kyphoplasty devices. (a) Kyphon Osteo Introducers (Diamond introducer, Bevel introducer, and drill shown). (b) Kyphon inflatable bone tamps. (c) Kyphon inflation syringe. (d) Kyphon cement delivery system. (e) Kyphon Latitude II Curette.





































Table 11.1 Providers of materials and equipment for balloon kyphoplasty

Balloon kyphoplasty


Ackermann


Alphatec Spine


BM Korea


BPB Medico


Biopsybell


Depuy Synthes


G-21


iMedicom


KMC-Maxxspine


Medtronic (Kyphon)


Osseon


Panmed US


Rontis


Taeyeon


Synimed



11.2.1 Bone Access Tools




  • Jamshidi-style needle: Typically, an 11- or 13-gauge cannulated needle used to gain access to the vertebral body via the pedicle or a peripedicular approach. The internal stylet may have a variety of bevel tips for increased penetration capability or for directional control. Once in position, the inner trocar is removed.



  • Kirschner’s wire (K-wire): It is placed in the cannula, which is then removed for a Seldinger-technique establishment of the working channel.



  • Osteointroducer: An 8- or 10-gauge cannulated introducer or working channel is placed over the K-wire, which is then removed. The osteointroducer may be beveled for directional control.



  • Drill: It is used to cut and channel through cancellous bone for placement of the balloon.



  • Curette: It is used to expand the cavity created by the drill to accommodate the expansion of the balloon.



11.2.2 Balloons Tamps and Inflation Devices




  • Inflatable bone tamps: These are available for use with 8- and 10-gauge introducers in three lengths (10, 15, and 20 mm) with volumes ranging from 3 to 6 mL and pressure ratings ranging from 300 to 700 psi.



  • Inflation device: It has a manometer with a digital pressure gauge for controlled inflation.



  • Cement delivery cannulas: It is an 8- or 10-gauge coaxial delivery system with an outer cannula and an inner rod or “pusher” for expelling cement.



11.2.3 Bone Cement


Acrylic bone cement (ABC) is the most commonly used cement for vertebral augmentation. The main components of ABC are solid and liquid acrylic compounds that cure rapidly when mixed at room temperature and even faster when exposed to body temperature. A number of brands are commercially available. Disadvantages of using ABC include nonbiodegradability and significant mechanical mismatch with the osseous components of the vertebral body. 1 Efforts have been made to improve the mechanical characteristics, porosity, and biodegradability of the products. Polymethyl methacrylate (PMMA) is the most popular bone cement. A modern version of PMMA was first used in the United Kingdom by Dr. John Charnley in total hip replacement surgery 2 and was Food and Drug Administration (FDA) approved for treating VCFs in 2004.


In 2017, calcium phosphate cement (CPC) was redesigned by incorporating starch and BaSO4 to create a new cement. Biomechanical strengths measured by in vitro and in vivo models were not less than that of PMMA, while its biodegradability and osseointegrative capacities were significantly enhanced compared to PMMA.


Other less commonly used bone cements include CPC, calcium sulfate cement (CSC), and magnesium phosphate cement (MPC). Chapter 7 provides a detailed discussion of the various cements and fill materials.



11.3 Diagnosis and Preoperative Preparation


A patient with an acute or subacute vertebral body compression fracture will almost always complain of severe back pain. Physical examination will reveal tenderness to palpation and percussion over the corresponding spinous process. Subsequent radiographs, CT, MR, and/or nuclear bone scan imaging are used to confirm and characterize a fracture. Short tau inversion recovery (STIR) and T1-weighted sequences on MR imaging are considered the gold standard for evaluating VCFs. There is a high degree of correlation between increased STIR signal and a pain-generating fracture and the T1-weighted images well demonstrate fracture lines and marrow signal changes (▶Fig. 11.2). If MR imaging is not possible, nuclear bone scan imaging may be used to demonstrate radionuclide uptake in an acute or subacute fracture and can be used in combination with CT scanning for accurate anatomic characterization of the fracture.

Fig. 11.2 Sagittal (a) T1 turbo spin echo (TSE), (b) T2 TSE, and (c) T2 short tau inversion recovery (STIR) images of an acute L1 vertebral compression fracture (white arrows). Bone marrow edema is hypointense on T1-weighted and hyperintense on T2 STIR images. These images are provided courtesy of Dr. M. R. Chambers

Patients undergoing kyphoplasty are often elderly, are deconditioned, and have inherent vulnerability to perioperative stress. For example, inhalation agents are affected by the minimum alveolar anesthetic concentration, which decreases approximately 6% for every decade. Clearance and the volume of the central compartment decrease with age. Metabolism of medications and their durations of action depend on renal or hepatic excretion. It is important to titrate doses and prudent to use short-acting drugs. Preoperative assessment of organ function and reserve is essential to know how the patient might react with anesthesia. 3 Although preoperative laboratory studies and testing will vary from patient to patient, we routinely include CBC with differential, chemistries, coagulation studies, anteroposterior (AP) chest radiograph, and an ECG.



11.4 Indications and Contraindications


Indications for kyphoplasty include intractable severe pain or moderate to severe persistent pain associated and correlating with a VCF. In 2017, a multidisciplinary expert panel of orthopaedic and neurosurgeons, interventional radiologists, and pain specialists, using the RAND/UCLA Appropriateness Method (RUAM), developed the Clinical Care Pathway (CCP), defining patient-specific recommendations for vertebral fragility fractures (VFF). The panel assessed the relative importance of signs and symptoms for the suspicion of VFF, the relevance of diagnostic procedures, and the appropriateness of vertebral augmentation versus nonsurgical management for a variety of clinical scenarios (▶Fig. 11.3). Their report included the following guidelines for relative and absolute contraindications (▶Table 11.2).

Fig. 11.3 The clinical care pathway (CCP) for the management of vertebral compression fractures.











































Table 11.2 Absolute and relative contraindications for kyphoplasty

Condition


Panel recommendation


Active infection at surgical site


Absolute contraindication for curent vertebral augmentation (VA).


Untreated blood-borne infection


Absolute contraindication. Preoperative antibiotic (parenteral) therapy is required. Once cultures are negative, following an appropriate period of antibiotic therapy, one can proceed with caution.


Osteomyelitis


Usually a strong contraindication for VA. In rare situations, VA may be considered, for example, if the patient is not stable for an open procedure and the infection is chronic and caused by a less virulent organism. The infection may then be controlled locally with antibiotic-loaded cement and long-term antibiotic suppression.


Pregnancy


Although VA is usually contraindicated in pregnant patients, there may be exceptional situations in which benefits could prevail over risks. Radiation exposure to the fetus should be minimized.


Allergy to fill material


Relative contraindication, depending on the severity of the allergy. If prior reactions were not associated with severe anaphylaxis, the allergy can be pretreated with steroids, Tylenol, and Benadryl. Alternatively, another fill material can be chosen.


Coagulopathy


Relative contraindication. Try to normalize/correct clotting function if possible (international normalized ratio [INR] < 1.7). The risk of bleeding should be balanced against the complications from bed rest. Caution in patients with thrombocytopenia (platelets less than 30,000/µL).


Spinal instability


Relative contraindication, depending on the degree of instability and level of fracture. If needed, plan an additional intervention to address instability, possibly but not necessarily in the same session.


Myelopathy from the fracture


Relative contraindication. Decompression and stabilization is the preferred option, but VA may be considered if the patient is unable to undergo surgery. Coordination with spine surgeon and neurologist is mandatory.


Neurologic deficit


Relative contraindication. Additional decompression with or without stabilization may be required. Patients should be informed about the risk of cement in the spinal canal. Coordination with spine surgeon and neurologist is mandatory.


Neural impingement


Relative contraindication, depending on the degree. Take extra care to avoid delivery of cement into canal or neural foramen. May need an additional open procedure.


Fracture retropulsion/canal compromise


Generally not a contraindication. Avoid hyperextension or aggravating stenosis. A CT scan may be used to determine integrity of posterior wall.


Absolute contraindications include active infection at the surgical site and untreated blood-borne infections. Strong contraindications include osteomyelitis, pregnancy, allergy to fill material, coagulopathy, spinal instability, myelopathy from the fracture, neurologic deficit, and neural impingement. Although dependent on degree, fracture repulsion and canal compromise are not generally a contraindication. Relative contraindications include cardiorespiratory compromise such that safe sedation or anesthesia cannot be achieved and in such cases the procedure may need to be done under local anesthesia. Breach of posterior vertebral cortex by tumor and tumor extension into the spinal canal are also relative contraindications for percutaneous vertebral augmentation techniques due to the potential for leakage of cement and/or displacement of tumor posteriorly.



11.5 Procedure


Kyphoplasty may be performed under general anesthesia or monitored anesthesia care (MAC) with conscious sedation and local anesthetic. In our practice, with rare exceptions, we perform kyphoplasty under general endotracheal anesthesia. In patients who cannot tolerate general anesthesia due to severe cardiopulmonary disease, for example, sedation with MAC is used with caution to avoid oversedation and respiratory compromise.


The patient is positioned prone on the operating table with shoulder and hip bolsters to aid in spinal extension and vertebral height restoration. All pressure points are padded and checked. With fluoroscopic guidance for localization, the area of planned surgery is prepped and draped in the usual sterile fashion. Appropriate prophylactic antibiotics are administered. Fluoroscopy is used to identify the pedicles and fractured vertebral body. Fluoroscopic views include true AP and lateral views. Another technique includes the en face view, directed down the longitudinal axis of the pedicle (▶Fig. 11.4).

Fig. 11.4 (a) Proper positioning of patient and anteroposterior and lateral fluoroscopy for kyphoplasty procedure. (b) The en face view provides an angle directly down the axis of the pedicle. (c) Fluoroscopic view: 20-degree ipsilateral right-sided oblique; starting position on the upper outer pedicle (white circle). Source: Kim CW, Garfin SR. Percutaneous cement augmentation techniques [vertebroplasty, kyphoplasty]. In: Vaccaro AR, Albert TJ. Spine Surgery: Tricks of the Trade. New York, NY: Thieme; 2009:250–254.; Source: Resnick DK, Barr JD, and Garfin SR. Vertebroplasty and Kyphoplasty. 1st ed. New York, NY: Thieme Publishers; 2005.

Local anesthetic is injected and a small stab incision is made with a no. 15 or a no. 11 blade approximately 1 cm superior and 2 cm lateral to the superior pedicle border. For a standard transpedicular approach, the Jamshidi needle is inserted and guided under direct fluoroscopy through the pedicle into the vertebral body. Other approaches and access techniques may also be used (see Chapter 6). The inner cannula is removed and replaced with a K-wire. Using the Seldinger technique, the Jamshidi cannula is removed and the cannulated osteointroducer is passed over the K-wire and advanced through two-thirds of the AP vertebral body diameter. The K-wire and inner cannula are removed when the outer cannula position is confirmed. The drill is passed manually with fluoroscopic guidance to create a void for the bone tamp and to obtain biopsy material for pathology. Core bone biopsies may be obtained through the introducer or a biopsy cannula (▶Fig. 11.1).


Next, a 10- or 15-mm bone tamp connected to a syringe prefilled with iodinated contrast is inserted through the cannula and, under direct fluoroscopic guidance, guided into the tract created by the drill. The radiopaque markers on the balloon tamp are visualized distal to the cannula sheath in both AP and lateral fluoroscopic images. When a bilateral approach is used, this procedure is repeated identically on the contralateral side.


The use of balloon tamps allows for safe and gentle end plate reduction, displacement of trabecular bone, and the creation of a void. The balloon tamps are incrementally inflated while being monitored with AP and lateral imaging. Digital manometers incorporated into the inflation devices demonstrate increases in pressure with each increase in volume. The pressure then gradually diminishes as the trabecular bone is displaced. This process is repeated as safely tolerated. Fracture reduction is guided by the degree of end plate distraction, height restoration, and reduction of kyphotic angulation. Pressure, volume, and fluoroscopic images will all dictate an endpoint. There should be no breach of lateral wall or anterior cortex of the vertebral body. The final balloon volume is recorded and one or both tamps are deflated and removed. The cement-delivery cannula is inserted through the working channel and advanced until the tip of the cannula reaches the anterior extent of the void created by the tamp, preferably just posterior to the anterior cortical wall of the vertebral body. The rod is used to expel cement from the cannula. As cement is delivered, the cannula and rod are retracted gently to allow room for the cement to fill the void. As the cement extends posteriorly, the injection should be slow to watch for extravasation. The cement should extend from superior to inferior end plate and be located between the pedicles. The cement can extend up to the posterior vertebral body wall, but it is important to watch for and recognize extension of cement beyond this margin. This process is repeated on each side until an adequate fill is achieved. As the cement begins to harden, the cannulas are removed. The internal fixation and stabilization of the vertebrae is achieved through the hardening of the cement injected into the vertebral body. Final fluoroscopic images are taken to document the final cement position. Wounds are dressed with Dermabond or Steri-Strips (▶Fig. 11.5).

Fig. 11.5 Pre- and postoperative images demonstrating cement filling and height restoration after kyphoplasty of an L1 compression fracture. Measurements are made at three points from posterior (measurement on a) to anterior (measurement on b). The height of the three points of the vertebral body is listed in millimeters. These images are provided courtesy of Dr. M. R. Chambers.


11.5.1 Bilateral versus Unilateral Approach


Several large systematic reviews of randomized control trials have examined the difference between bilateral and unilateral approaches for kyphoplasty. Some differences were observed between the two approaches in terms of height restoration, correction of kyphotic angulation, and patient ratings of pain. 4 , 5


In an analysis of 15 randomized control trials including 850 patients, Yang et al found no difference in quality-of-life or complications from surgery between bilateral and unilateral kyphoplasty. 4 Chen et al found that the unilateral approach resulted in a shorter operative time, smaller amount of cement injected, and lower risk of cement leakage. 5 There were no statistically significant differences in visual analog scale pain scores, height changes, or kyphotic angle changes between the groups. 5 Papanastassiou et al examined the differences between unilateral and bilateral kyphoplasty in multiple myeloma patients and found no difference in clinical or radiological outcomes. 6 Huang et al in a review of five studies including 253 patients found no clinically important differences but suggested that unilateral kyphoplasty is advantageous due to decreased operative time and cost. 7 Similarly, in a systematic review and meta-analysis including 563 patients, Sun et al noted that unilateral approach led to decreased surgical time, cement consumption, and cement leakage; reduced radiation dose and hospitalization costs; and improved short-term general health. 8


There are also substantial data supporting the bilateral approach for optimal outcomes in vertebral augmentation with balloon kyphoplasty. In a retrospective study of 296 patients with osteoporotic VCFs, Bozkurt et al showed that although there was no statistically significant difference between unilateral kyphoplasty and vertebroplasty regarding height restoration of the fractured vertebral body, there was a further advantage of significant height restoration of bilateral kyphoplasty compared to the other two techniques. 9 The advantage of height restoration with a bilateral technique is also supported by a meta-analysis of five studies that reported a short-term follow-up that indicated bilateral balloon kyphoplasty had a significantly (p = 0.03) better degree of anterior vertebral height restoration than unilateral balloon kyphoplasty. 10


In general, based on the above studies and analyses, a unilateral approach provides an advantage regarding procedure time, procedure and hospital costs, radiation dose, and improved short-term health and cement extravasation. Additionally, there appears to be no significant difference in the unilateral versus bilateral approach with respect to pain reduction, quality-of-life improvement, or procedural complications. Finally, balloon kyphoplasty using a bilateral approach has been shown to provide significantly better short-term height restoration than the same procedure performed via a unilateral approach.

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May 3, 2020 | Posted by in NEUROSURGERY | Comments Off on 11 Balloon Kyphoplasty

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