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The incidence and risk factor of deep venous thrombosis after arthroscopically assisted anterior cruciate ligament reconstruction
Journal of Orthopaedic Science xxx (xxxx) xxx
Contents lists available at ScienceDirect
Journal of Orthopaedic Science journal homepage: http://www.elsevier.com/locate/jos
Original Article
The incidence and risk factor of deep venous thrombosis after arthroscopically assisted anterior cruciate ligament reconstruction Hiroyuki Oshiba a, b, *, Masashi Nawata a, Susumu Morioka a, Takashige Momose a, Takashi Maeda a, Yukio Nakatsuchi a a b
Department of Orhtopaedic Surgery, Marunouchi Hospital, Nagisa1-7-45, Matsumoto, 390-8601, Japan Department of Orhtopaedic Surgery, Shinshu University School of Medicine, Asahi 3-1-1, Matsumoto, 390-8621, Japan
a r t i c l e i n f o
a b s t r a c t
Article history: Received 19 December 2018 Received in revised form 9 May 2019 Accepted 19 May 2019 Available online xxx
Purpose: To retrospectively analyze the incidence and risk factors of deep venous thrombosis (DVT) detected by ultrasonography after arthroscopically assisted Anterior Cruciate Ligament Reconstruction (ACLR). Methods: We retrospectively reviewed medical records of arthroscopically assisted ACLR surgery performed at our institution between 2012 and 2015. Revision ACLR, bone patella tendon bone (BTB) graft reconstruction, and concomitant multiple ligament reconstructions were excluded. We performed a standardized double-bundle reconstruction procedure using hamstrings graft for ACLR. All patients routinely received DVT screening by using venous ultrasonography on postoperative day 7 from 2012 to 2013, and postoperative days 7 and 14 from 2014 to 2015. The prevalence of DVT was calculated and clinical factors such as age, gender, Body Mass Index (BMI), operative time, and duration of tourniquet application were evaluated in relation to the risk factor of DVT. Results: Two hundred and fifty-six patients (129 men and 127 women) with a mean age of 28.9 were enrolled. Sixteen patients (6.6%) were detected with DVT on postoperative day 7. Among 146 patients who received venous ultrasonography on both postoperative days 7 and 14, DVT were detected in five additional patients on postoperative day 14. In a total of 21 patients who were diagnosed with DVT, two were proximal, the remaining 19 were distal, and no patient had progressed to pulmonary embolism (PE). In terms of predisposing factors for developing DVT on postoperative day 7, only age 30 showed a statistically significant higher risk of DVT (P ¼ 0.03). Conclusion: Incidence of DVT after ACLR detected by ultrasonography on postoperative day 7 was 6.6%. Patients aged 30 years have a potentially higher risk for developing DVT. Great care for DVT should be taken if prolonged immobilization is applied after ACLR surgery. Level of evidence: Level Ⅳ © 2019 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.
1. Introduction Deep venous thrombosis (DVT) after arthroscopic surgery was once considered a relatively rare complication with a reported incidence ranging from 3.5% [1] to 4.4% [2]. However, with the improvement of diagnostic accuracy, many authors have warned that there may be a higher incidence of DVT after arthroscopic surgery [3,4]. In the 1980s, anterior cruciate ligament
* Corresponding author. Marunouchi hospital, Nagisa1-7-45, Matsumoto, 3908601, Japan. Fax: þ81 263 28 3000. E-mail address: [email protected] (H. Oshiba).
reconstruction (ACLR) surgery transitioned from open to arthroscopically assisted techniques [5]. In comparison to arthroscopic meniscal or synovial surgery, arthroscopically assisted ACLR may potentially have a much higher risk of DVT due to additional tissue damages of the graft harvest site and immobilization period requiring postoperative management. Jaureguito et al. investigated the incidence of DVT after arthroscopic knee surgery using duplex ultrasonography and suggested a slightly higher incidence of DVT in the arthroscopically assisted ligament or osteotomy surgery group compared to the intraarticular arthroscopy group, though there was no statistically significant difference [11]. On the other hand, with an increased interest in sports to maintain physical fitness among the middle-aged population, the
https://doi.org/10.1016/j.jos.2019.05.014 0949-2658/© 2019 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.
Please cite this article as: Oshiba H et al., The incidence and risk factor of deep venous thrombosis after arthroscopically assisted anterior cruciate ligament reconstruction, Journal of Orthopaedic Science, https://doi.org/10.1016/j.jos.2019.05.014
2
H. Oshiba et al. / Journal of Orthopaedic Science xxx (xxxx) xxx
incidence of the anterior cruciate ligament (ACL) tear in this age group has been increased. Several studies support a strong association between ACL deficient knee and the development of osteoarthritis [6e8]. In addition, Sanders et al. showed that patients treated with ACLR have a significantly lower risk of secondary meniscal tear, symptomatic arthritis, and total knee arthroplasty. [8] From these encouraging results, the opportunity of performing ACLR in middle-aged patients has increased in recent years. In general, it is known that the risk of a vascular event increases with age. Ye et al. reported that the incidence of asymptomatic DVT after arthroscopic ACLR detected by venography was 14%, and a higher incidence was found in patients aged 35 years [9]. However, 14% of incidence may be a result of overestimation, because their study had eliminated patients younger than 18 years old who are generally thought to have a lower risk of DVT. Venous ultrasonography, especially duplex ultrasound (B-mode imaging and Doppler waveform analysis) has become the most widely used noninvasive diagnostic method for DVT [10] and can be safely used in adolescents. Our aim of this study is to uncover the incidence of DVT after arthroscopically assisted ACLR diagnosed by duplex ultrasound and to investigate risk factors for developing DVT. We hypothesized that the incidence of DVT after arthroscopic ACLR detected by venous ultrasonography would be relatively higher than the previously reported incidence after arthroscopic surgery, especially in the middle-age group. 2. Materials and methods 2.1. Participants We retrospectively analyzed medical records of 283 arthroscopic ACLRs performed at our institution between 2012 and 2015. The exclusion criteria were as follows: revision ACLR, bone patella tendon bone (BTB) graft reconstruction, concomitant multiple ligament reconstructions, history of DVT or pulmonary embolism (PE), and patients who were already taking anticoagulation medication. All patients had routinely received DVT screening by using venous ultrasonography at postoperative day 7 from 2012 to 2013 and both postoperative days 7 and 14 from 2014 to 2015. Results of ultrasonography, patient demographic factors (age, gender, BMI), and surgery-related factors (duration of surgery, duration of tourniquet application) were collected from medical records for analysis of the incidence and risk factors for DVT. Due to the retrospective nature of this study, we obtained a waiver of consent from our Institutional Review Board, and informed consent was obtained from each patient. 2.2. Surgical procedures and postoperative management All procedures were performed under general anaesthesia. Continuous epidural anaesthesia was also used for postoperative pain control for two days after surgery. ACLR was performed with a standardized double-bundle reconstruction technique using hamstrings graft harvested ipsilaterally in all patients. After an arthroscopic evaluation of the ruptured ACL and meniscus, we harvested the semitendinosus (ST) tendon without an inflating pneumatic tourniquet. If the length or diameter of the ST tendon was insufficient for a double-bundle graft, the ipsilateral gracilis tendon was additionally harvested. A meniscal suture or partial meniscectomy was first performed if there were concomitant meniscal injuries. Before starting the partial synovectomy of the intercondylar space, a pneumatic tourniquet was inflated to 300 mmHg. We used a transtibial technique for femoral tunnel drilling, and ENDOBUTTON and Double Spike Plates (Smith and Nephew plc. London, UK) were used for the fixation of the femoral and tibial sides, respectively. No
patients received a mechanical prophylaxis of DVT such as a foot pump system for maintaining venous blood flow after surgery. No patients received anticoagulant drugs. Nonsteroidal antiinflammatory drugs (NSAIDS) or acetaminophen were used for postoperative pain control. With regards to postoperative treatment, the reconstructed knee was immobilized for 2 weeks, and range of motion exercise and partial weight-bearing was subsequently allowed under the supervision of a physiotherapist. Full weight-bearing was permitted at 4 weeks postoperatively. We did not change rehabilitation protocol in case of distal and popliteal DVT. In case of massive proximal DVT, we consulted cardiovascular physician when to allow weight bearing. However other part of postoperative rehabilitation such as range of motion exercise and trunk muscle training had not changed. 2.3. Venous ultrasonography for detecting DVT All ultrasonography was performed with a compression technique on B-mode imaging and Doppler waveform analysis (duplex ultrasound) using a ProSound Alpha 7 ultrasound system (Hitachi Aloka Medical America Inc. Wallingford, USA) by three trained radiological technicians. The area of scan was distal to the inguinal ligament and covered a region from the femoral vein to the soleus vein. Thrombosis was classified as proximal if it was proximal to the popliteal vein with or without calf vein thrombosis, and as distal if it was isolated from the calf vein. Patients who were diagnosed with proximal thrombosis soon received a contrast enhanced CT scan to confirm the area and size of DVT and any signs of PE. A therapeutic dose of heparin was then administered by continuous IV infusion, and its effects were monitored by measuring the activated partial thromboplastin time (APTT). Patients who were diagnosed with distal thrombosis were prescribed with warfarin while adjusting its dose by monitoring the prothrombin time international normalized ratio (PT-INR) or edoxaban tosilate hydrate. 2.4. Statistical analysis The incidence of DVT on postoperative day 7 was calculated. Multivariate logistic-regression models (simultaneous entry method) were prepared to estimate the risk for developing DVT associated with potential predictors, including patient demographic variables (age, gender, BMI) and surgery-related variables (duration of surgery, duration of tourniquet application). Inclusion of these variables in the models was based on the existing knowledge of the risk of DVT. [9,15] The level of statistical significance was set at P < 0.05. Statistical analyses were performed with SPSS ver.23. 3. Results During a four-year period, 283 arthroscopic ACLR were performed at our institution. The following were excluded: primary BTB reconstruction, 3 cases; revision ACLR, 13 cases; concomitant Medial Collateral Ligament Reconstruction (MCLR), 9 cases; and concomitant Posterior Cruciate Ligament Reconstruction (PCLR) and MCLR, 2 cases. The remaining 256 patients (129 men and 127 women) with a mean age of 28.9 years were enrolled. The mean BMI, duration of surgery, duration of tourniquet application were 23.2 kg/m2, 80.6 min, and 48.6 min, respectively. DVT was detected in 16 patients (6.6%) at postoperative day 7. One of these 16 patients exhibited a proximal type DVT, with symptoms of apparent edema in the affected leg. Four of the remaining 15 patients were observed with distal DVT 40 mm in length, and one of these four patients had a symptom of apparent
Please cite this article as: Oshiba H et al., The incidence and risk factor of deep venous thrombosis after arthroscopically assisted anterior cruciate ligament reconstruction, Journal of Orthopaedic Science, https://doi.org/10.1016/j.jos.2019.05.014
H. Oshiba et al. / Journal of Orthopaedic Science xxx (xxxx) xxx
edema. In 136 patients who received venous ultrasonography on both postoperative days 7 and 14, DVT was detected in five additional patients on postoperative day 14. One of these five patients was observed with an asymptomatic proximal DVT, and one of the remaining four distal DVT was 40 mm in length. In a total of 21 patients who were diagnosed with DVT, two were proximal and the remaining 19 were distal type. During the minimum 2-year followup period, no patient had progressed to PE, and all patients were confirmed with a disappearance of DVT by ultrasonography within 3 months after anticoagulant prescription. The odds of potential risk factors for developing DVT during 7 days and 14 days from maltivariate analyses are summarized in Tables 1 and 2, respectively. Age 30 years was a significantly higher risk (P ¼ 0.03) compared to the younger age group at postoperative day 7. (OR:3.59, 95%CI:1.11-11.68). Gender difference, BMI categorized as overweight (25.0e29.9 kg/m3) or obese (30 kg/m3) compared to normal (18.5e24.9 kg/m3), duration of surgery 90 min compared to < 90 min, and duration of tourniquet application 60 min compared to < 60 min did not show a significantly higher risk for DVT. The distribution of DVT-positive and -negative populations in each generation is summarized in Fig. 1. A third of our study population consisted of patients under 20 years of age. Note the lower incidence of DVT in this age group. 4. Discussion The most important findings of this study was that 18 out of 256 patients developed DVT after arthroscopically assisted ACLR by using duplex ultrasound performed on postoperative day 7. The total incidence of 6.6% from our results was lower compared to that of the 14% detected by venography that was reported by Ye et al. [9] Our results included 64 patients aged < 18 years that were excluded in the study by Ye et al., and these patients consisted of a fourth of our study population. Taking the lower incidence of DVT in this age group into consideration as shown in Fig. 1, this discrepancy may not be a result of the difference in diagnostic accuracy between venography and duplex ultrasound, but rather the difference in the study population. As Grady-Benson et al. [12] suggested, the diagnostic accuracy of duplex ultrasound is almost equal to that of venography. In addition, the great advantage of ultrasonography lies in its safety and noninvasiveness that can be facilitated across all generations; therefore, it has been widely recognized as a primary modality for diagnosis and exclusion of acute DVT in recent years [10]. On the other hand, compared to other reports relating the incidence or prevalence of DVT after arthroscopic intraarticular knee surgery [1,2], our results showed a relatively higher incidence that were comparable to those reported by Jaureguito et al. [11] This may be partly due to extra-articular surgical invasion such as
3
graft harvest, but the postoperative immobilization period may exert a greater influence. Although there is no consensus on the immobilization period after ACLR, immobilization seems to induce a positive effect against the initial tunnel enlargement, especially for hamstrings graft ACLR [13]. Packer et al. reported that immobilization enhance graft tunnel healing/anchoring rather than immediate rehabilitation [14]. We had mostly agreed these opinions, so we set a 2-week immobilization period in our postoperative rehabilitation program. In our series of 136 patients who received venous ultrasonography on both postoperative days 7 and 14, five DVT that included one proximal and one large distal thrombus were surprisingly detected on postoperative day 14. To our knowledge, this is the first report of duplex ultrasound DVT screening performed twice between perioperative periods after ACLR. This suggested that prolonged immobilization increases the risk of developing large DVT that may lead to PE and demonstrated the necessity of DVT screening when prolonged immobilization is anticipated. Gaskill et al. [15] investigated 15,756 cases of ACLR from the US Military Healthcare System database and reported that the prevalence of symptomatic DVT was as low as 0.53%, but risk was increased in patients aged 35 years, patients with a history of nicotine use, and patients undergoing concomitant high tibial osteotomy or concomitant PCLR. In our study, symptomatic DVT was detected in two cases out of 256 patients (0.78%), and most of the DVT cases were asymptomatic. However, we warn that these asymptomatic DVT cases contained one proximal and five distal large DVT that could potentially progress to proximal DVT without anticoagulant treatment. In terms of potential risk factors, our series showed that patients aged 30 years have a significantly higher risk of developing DVT (P ¼ 0.03), which maintains consistency with the past literatures. Our series excluded concomitant procedures, but surgical factors such as duration of surgery 90 min and duration of tourniquet application 60 min did not increase the risk for DVT. 4.1. Limitations There are some limitations of this study. First, we did not perform preoperative duplex ultrasonography. Patients with positive DVT may have included those who had a preoperative onset of DVT during the waiting period following their injury or those who had DVT prior to their ACL injury. Secondly, asymptomatic PE could have been overlooked, since PE was not screened by contrast CT unless proximal DVT was confirmed. In addition, post-discharge follow-up by ultrasonographic examination was only performed on DVT positive patients in order to confirm the disappearance of thrombi after oral anticoagulant
Table 1 Multivariate Analysis of Risk Factors for DVTa at Postoperative day 7. Variables of Interest
Reference Category (DVT þ/n)e
Gender Age Group BMIb Category
Men (10/129) Age<30 years old (4/140) <25 (normal) (11/196)
Duration of Operation Duration of Tourniquet Application
<90 min (9/183) <60 min (11/190)
a b c d e
Comparator Category (DVT þ/n)
Women (6/127) Age30 years old (12/116) 25 (overweight, obese) (5/60) 90 min (7/73) 60 min (5/66)
DVT ORc(95%CId)
P-Value
0.76 (0.26e2.27) 3.59 (1.11e11.68) 1.40 (0.43e4.50)
0.63 0.03 0.57
2.61 (0.65e10.41) 0.64 (0.15e2.75)
0.18 0.55
DVT: deep venous thrombosis. BMI: body mass index. OR: Odds Ratio. CI: Confidence Interval. (number of DVT positive patient/total number of patient).
Please cite this article as: Oshiba H et al., The incidence and risk factor of deep venous thrombosis after arthroscopically assisted anterior cruciate ligament reconstruction, Journal of Orthopaedic Science, https://doi.org/10.1016/j.jos.2019.05.014
4
H. Oshiba et al. / Journal of Orthopaedic Science xxx (xxxx) xxx
Table 2 Multivariate Analysis of Risk Factors for DVTa at Postoperative day 14. Variables of Interest
Gender Age Group BMIb Category Duration of Operation Duration of Tourniquet Application
Reference Category (DVTþ/n)e
Men (1/64) Age<30 years old (0/75) <25 (normal) (2/100) <90 min (5/112) <60 min (5/116)
Comparator Category (DVTþ/n)
Women (4/72) Age30 years old (5/61) 25 (overweight, obese) (3/36) 90 min (0/24) 60 min (0/20)
DVT ORc(95%CId)
P-Value
4.78 (0.48e47.51) * 2.94 (0.42e20.55)
0.18 0.28
* Blank in the table: impossible to calculate. a DVT: deep venous thrombosis. b BMI: body mass index. c OR: Odds Ratio. d CI: Confidence Interval. e (Number of DVT positive patient/total number).
Acknowledgments The authors thanks fot Dr. Shota Ikegami for his statistical advice, and for Mr. Sho Steven Sugita for his English editorial assistance. References
Fig. 1. Distribution of DVT Positive þ/Negative- Population in Each Age Group. The black and white numbers in the bar represent the number of DVT positive and negative patients, respectively.
therapy. Therefore, the onset of asymptomatic DVT after hospital discharge could possibly be overlooked; however, we believe that a new onset of DVT would be extremely rare when the immobilization period of the affected is complete, weight-bearing exercises are started, and as a result, the stagnated blood flow in the lower limbs is relieved. Lastly, we could not conduct interrater reliability and test-retest reliability for duplex ultrasound technique among three technicians, thus the result may potentially suffer interrater variability among them.
5. Conclusions The incidence of DVT after ACLR detected by duplex ultrasound on postoperative day 7 was 6.6%. Postoperative management consisting of a 2-week immobilization may have triggered the detection of five additional DVT cases out of 136 patients on postoperative day 14. Age 30 years has a potentially higher risk for developing DVT. Great care for DVT should be taken if prolonged immobilization is applied after ACLR surgery.
Conflict of interest All the authors have nothing to disclose.
[1] Williams Jr JS, Hulstyn MJ, Fadale PD, Lindy PB, Ehrlich MG, Dorfman G. Incidence of deep vein thrombosis after arthroscopic knee surgery: a prospective study. Arthroscopy 1995 Dec;11(6):701e5. [2] Stringer MD, Steadman CA, Hedges AR, Thomas EM, Morley TR, Kakkar VV. Deep vein thrombosis after elective knee surgerydan incidence in 312 patients. J Bone Joint Surg Br 1989 May;71(3):492e7. [3] Schippinger G, Wirnsberger GH, Obernosterer A, Babinski K. Thromboembolic complications after arthroscopic knee surgery. Incidence and risk factors in 101 patients. Acta Orthop Scand 1998 Apr;69(2):144e6. [4] Demers C, Marcoux S, Ginsberg JS, Laroche F, Cloutier R, Poulin J. Incidence of venographically proved deep vein thrombosis after knee arthroscopy. Arch Intern Med 1998 Jan 12;158(1):47e50. [5] Gillquist J, Odensten M. Arthroscopic reconstruction of the anterior cruciate ligament. Arthroscopy 1988;4(1):5e9. [6] Mihelic R, Jurdana H, Jotanovic Z, Madjarevic T, Tudor A. Long-term results of anterior cruciate ligament reconstruction: a comparison with non-operative treatment with a follow up of 17-20 years. Int Orthop 2011 Jul;35(7):1093e7. [7] Lohmander LS, Englund PM, Dahl LL, Roos EM. The long-term consequence of anterior cruciate ligament and meniscus injuries: osteoarthritis. Am J Sports Med 2007 Oct;35(10):1756e69. [8] Sanders TL, Kremers HM, Bryan AJ, Fruth KM, Larson DR, Pareek A, Levy BA, Stuart MJ, Dahm DL, Krych AJ. Is anterior cruciate ligament reconstruction effective in preventing secondary meniscal tears and osteoarthritis? Am J Sports Med 2016 Jul;44(7):1699e707. [9] Ye S, Dongyang C, Zhihong X, Dongguan S, Jin D, Jianghui Q, Pu Y, Huacheng H, Wei S, Qing J. The incidence of deep venous thrombosis after arthroscopically assisted anterior cruciate ligament reconstruction. Arthroscopy 2013 Apr;29(4):742e7. [10] Zierler BK. Ultrasonography and diagnosis of venous thromboembolism. Circulation 2004 Mar 30;109(12 Suppl. 1):l9e14. [11] Jaureguito JW, Greenwald AE, Wilcox JF, Paulos LE, Rosenburg TD. The incidence of deep venous thrombosis after arthroscopic knee surgery. Am J Sports Med 1999 Nov-Dec;27(6):707e10. [12] Grady-Benson JC, Oishi CS, Hanson PB, Colwell Jr CW, Otis SM, Walker RH. Postoperative surveillance for deep venous thrombosis with duplex ultrasonography after total knee arthroplasty. J Bone Joint Surg Am 1994 Nov;76(11): 1649e57. [13] Vadal`a A, Iorio R, De Carli A, Argento G, Di Sanzo V, Conteduca F, Ferretti A. The effect of accelerated, brace free, rehabilitation on bone tunnel enlargement after ACL reconstruction using hamstring tendons: a CT study. Knee Surg Sport Traumatol Arthrosc 2007 Apr;15(4):365e71. [14] Packer JD, Bedi A, Fox AJ, Gasinu S, Imhauser CW, Stasiak M, Deng XH, Rodeo SA. Effect of immediate and delayed high-strain loading on tendon-tobone healing after anterior cruciate ligament reconstruction. J Bone Joint Surg Am 2014 May 7;96(9):770e7. [15] Gaskill T, Pullen M, Bryant B, Sicignano N, Evans AM, DeMaio M. The prevalence of symptomatic deep venous thrombosis and pulmonary embolism after anterior cruciate ligament reconstruction. Am J Sports Med 2015 Nov;43(11): 2714e9.
Please cite this article as: Oshiba H et al., The incidence and risk factor of deep venous thrombosis after arthroscopically assisted anterior cruciate ligament reconstruction, Journal of Orthopaedic Science, https://doi.org/10.1016/j.jos.2019.05.014
Contents lists available at ScienceDirect
Journal of Orthopaedic Science journal homepage: http://www.elsevier.com/locate/jos
Original Article
The incidence and risk factor of deep venous thrombosis after arthroscopically assisted anterior cruciate ligament reconstruction Hiroyuki Oshiba a, b, *, Masashi Nawata a, Susumu Morioka a, Takashige Momose a, Takashi Maeda a, Yukio Nakatsuchi a a b
Department of Orhtopaedic Surgery, Marunouchi Hospital, Nagisa1-7-45, Matsumoto, 390-8601, Japan Department of Orhtopaedic Surgery, Shinshu University School of Medicine, Asahi 3-1-1, Matsumoto, 390-8621, Japan
a r t i c l e i n f o
a b s t r a c t
Article history: Received 19 December 2018 Received in revised form 9 May 2019 Accepted 19 May 2019 Available online xxx
Purpose: To retrospectively analyze the incidence and risk factors of deep venous thrombosis (DVT) detected by ultrasonography after arthroscopically assisted Anterior Cruciate Ligament Reconstruction (ACLR). Methods: We retrospectively reviewed medical records of arthroscopically assisted ACLR surgery performed at our institution between 2012 and 2015. Revision ACLR, bone patella tendon bone (BTB) graft reconstruction, and concomitant multiple ligament reconstructions were excluded. We performed a standardized double-bundle reconstruction procedure using hamstrings graft for ACLR. All patients routinely received DVT screening by using venous ultrasonography on postoperative day 7 from 2012 to 2013, and postoperative days 7 and 14 from 2014 to 2015. The prevalence of DVT was calculated and clinical factors such as age, gender, Body Mass Index (BMI), operative time, and duration of tourniquet application were evaluated in relation to the risk factor of DVT. Results: Two hundred and fifty-six patients (129 men and 127 women) with a mean age of 28.9 were enrolled. Sixteen patients (6.6%) were detected with DVT on postoperative day 7. Among 146 patients who received venous ultrasonography on both postoperative days 7 and 14, DVT were detected in five additional patients on postoperative day 14. In a total of 21 patients who were diagnosed with DVT, two were proximal, the remaining 19 were distal, and no patient had progressed to pulmonary embolism (PE). In terms of predisposing factors for developing DVT on postoperative day 7, only age 30 showed a statistically significant higher risk of DVT (P ¼ 0.03). Conclusion: Incidence of DVT after ACLR detected by ultrasonography on postoperative day 7 was 6.6%. Patients aged 30 years have a potentially higher risk for developing DVT. Great care for DVT should be taken if prolonged immobilization is applied after ACLR surgery. Level of evidence: Level Ⅳ © 2019 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.
1. Introduction Deep venous thrombosis (DVT) after arthroscopic surgery was once considered a relatively rare complication with a reported incidence ranging from 3.5% [1] to 4.4% [2]. However, with the improvement of diagnostic accuracy, many authors have warned that there may be a higher incidence of DVT after arthroscopic surgery [3,4]. In the 1980s, anterior cruciate ligament
* Corresponding author. Marunouchi hospital, Nagisa1-7-45, Matsumoto, 3908601, Japan. Fax: þ81 263 28 3000. E-mail address: [email protected] (H. Oshiba).
reconstruction (ACLR) surgery transitioned from open to arthroscopically assisted techniques [5]. In comparison to arthroscopic meniscal or synovial surgery, arthroscopically assisted ACLR may potentially have a much higher risk of DVT due to additional tissue damages of the graft harvest site and immobilization period requiring postoperative management. Jaureguito et al. investigated the incidence of DVT after arthroscopic knee surgery using duplex ultrasonography and suggested a slightly higher incidence of DVT in the arthroscopically assisted ligament or osteotomy surgery group compared to the intraarticular arthroscopy group, though there was no statistically significant difference [11]. On the other hand, with an increased interest in sports to maintain physical fitness among the middle-aged population, the
https://doi.org/10.1016/j.jos.2019.05.014 0949-2658/© 2019 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.
Please cite this article as: Oshiba H et al., The incidence and risk factor of deep venous thrombosis after arthroscopically assisted anterior cruciate ligament reconstruction, Journal of Orthopaedic Science, https://doi.org/10.1016/j.jos.2019.05.014
2
H. Oshiba et al. / Journal of Orthopaedic Science xxx (xxxx) xxx
incidence of the anterior cruciate ligament (ACL) tear in this age group has been increased. Several studies support a strong association between ACL deficient knee and the development of osteoarthritis [6e8]. In addition, Sanders et al. showed that patients treated with ACLR have a significantly lower risk of secondary meniscal tear, symptomatic arthritis, and total knee arthroplasty. [8] From these encouraging results, the opportunity of performing ACLR in middle-aged patients has increased in recent years. In general, it is known that the risk of a vascular event increases with age. Ye et al. reported that the incidence of asymptomatic DVT after arthroscopic ACLR detected by venography was 14%, and a higher incidence was found in patients aged 35 years [9]. However, 14% of incidence may be a result of overestimation, because their study had eliminated patients younger than 18 years old who are generally thought to have a lower risk of DVT. Venous ultrasonography, especially duplex ultrasound (B-mode imaging and Doppler waveform analysis) has become the most widely used noninvasive diagnostic method for DVT [10] and can be safely used in adolescents. Our aim of this study is to uncover the incidence of DVT after arthroscopically assisted ACLR diagnosed by duplex ultrasound and to investigate risk factors for developing DVT. We hypothesized that the incidence of DVT after arthroscopic ACLR detected by venous ultrasonography would be relatively higher than the previously reported incidence after arthroscopic surgery, especially in the middle-age group. 2. Materials and methods 2.1. Participants We retrospectively analyzed medical records of 283 arthroscopic ACLRs performed at our institution between 2012 and 2015. The exclusion criteria were as follows: revision ACLR, bone patella tendon bone (BTB) graft reconstruction, concomitant multiple ligament reconstructions, history of DVT or pulmonary embolism (PE), and patients who were already taking anticoagulation medication. All patients had routinely received DVT screening by using venous ultrasonography at postoperative day 7 from 2012 to 2013 and both postoperative days 7 and 14 from 2014 to 2015. Results of ultrasonography, patient demographic factors (age, gender, BMI), and surgery-related factors (duration of surgery, duration of tourniquet application) were collected from medical records for analysis of the incidence and risk factors for DVT. Due to the retrospective nature of this study, we obtained a waiver of consent from our Institutional Review Board, and informed consent was obtained from each patient. 2.2. Surgical procedures and postoperative management All procedures were performed under general anaesthesia. Continuous epidural anaesthesia was also used for postoperative pain control for two days after surgery. ACLR was performed with a standardized double-bundle reconstruction technique using hamstrings graft harvested ipsilaterally in all patients. After an arthroscopic evaluation of the ruptured ACL and meniscus, we harvested the semitendinosus (ST) tendon without an inflating pneumatic tourniquet. If the length or diameter of the ST tendon was insufficient for a double-bundle graft, the ipsilateral gracilis tendon was additionally harvested. A meniscal suture or partial meniscectomy was first performed if there were concomitant meniscal injuries. Before starting the partial synovectomy of the intercondylar space, a pneumatic tourniquet was inflated to 300 mmHg. We used a transtibial technique for femoral tunnel drilling, and ENDOBUTTON and Double Spike Plates (Smith and Nephew plc. London, UK) were used for the fixation of the femoral and tibial sides, respectively. No
patients received a mechanical prophylaxis of DVT such as a foot pump system for maintaining venous blood flow after surgery. No patients received anticoagulant drugs. Nonsteroidal antiinflammatory drugs (NSAIDS) or acetaminophen were used for postoperative pain control. With regards to postoperative treatment, the reconstructed knee was immobilized for 2 weeks, and range of motion exercise and partial weight-bearing was subsequently allowed under the supervision of a physiotherapist. Full weight-bearing was permitted at 4 weeks postoperatively. We did not change rehabilitation protocol in case of distal and popliteal DVT. In case of massive proximal DVT, we consulted cardiovascular physician when to allow weight bearing. However other part of postoperative rehabilitation such as range of motion exercise and trunk muscle training had not changed. 2.3. Venous ultrasonography for detecting DVT All ultrasonography was performed with a compression technique on B-mode imaging and Doppler waveform analysis (duplex ultrasound) using a ProSound Alpha 7 ultrasound system (Hitachi Aloka Medical America Inc. Wallingford, USA) by three trained radiological technicians. The area of scan was distal to the inguinal ligament and covered a region from the femoral vein to the soleus vein. Thrombosis was classified as proximal if it was proximal to the popliteal vein with or without calf vein thrombosis, and as distal if it was isolated from the calf vein. Patients who were diagnosed with proximal thrombosis soon received a contrast enhanced CT scan to confirm the area and size of DVT and any signs of PE. A therapeutic dose of heparin was then administered by continuous IV infusion, and its effects were monitored by measuring the activated partial thromboplastin time (APTT). Patients who were diagnosed with distal thrombosis were prescribed with warfarin while adjusting its dose by monitoring the prothrombin time international normalized ratio (PT-INR) or edoxaban tosilate hydrate. 2.4. Statistical analysis The incidence of DVT on postoperative day 7 was calculated. Multivariate logistic-regression models (simultaneous entry method) were prepared to estimate the risk for developing DVT associated with potential predictors, including patient demographic variables (age, gender, BMI) and surgery-related variables (duration of surgery, duration of tourniquet application). Inclusion of these variables in the models was based on the existing knowledge of the risk of DVT. [9,15] The level of statistical significance was set at P < 0.05. Statistical analyses were performed with SPSS ver.23. 3. Results During a four-year period, 283 arthroscopic ACLR were performed at our institution. The following were excluded: primary BTB reconstruction, 3 cases; revision ACLR, 13 cases; concomitant Medial Collateral Ligament Reconstruction (MCLR), 9 cases; and concomitant Posterior Cruciate Ligament Reconstruction (PCLR) and MCLR, 2 cases. The remaining 256 patients (129 men and 127 women) with a mean age of 28.9 years were enrolled. The mean BMI, duration of surgery, duration of tourniquet application were 23.2 kg/m2, 80.6 min, and 48.6 min, respectively. DVT was detected in 16 patients (6.6%) at postoperative day 7. One of these 16 patients exhibited a proximal type DVT, with symptoms of apparent edema in the affected leg. Four of the remaining 15 patients were observed with distal DVT 40 mm in length, and one of these four patients had a symptom of apparent
Please cite this article as: Oshiba H et al., The incidence and risk factor of deep venous thrombosis after arthroscopically assisted anterior cruciate ligament reconstruction, Journal of Orthopaedic Science, https://doi.org/10.1016/j.jos.2019.05.014
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edema. In 136 patients who received venous ultrasonography on both postoperative days 7 and 14, DVT was detected in five additional patients on postoperative day 14. One of these five patients was observed with an asymptomatic proximal DVT, and one of the remaining four distal DVT was 40 mm in length. In a total of 21 patients who were diagnosed with DVT, two were proximal and the remaining 19 were distal type. During the minimum 2-year followup period, no patient had progressed to PE, and all patients were confirmed with a disappearance of DVT by ultrasonography within 3 months after anticoagulant prescription. The odds of potential risk factors for developing DVT during 7 days and 14 days from maltivariate analyses are summarized in Tables 1 and 2, respectively. Age 30 years was a significantly higher risk (P ¼ 0.03) compared to the younger age group at postoperative day 7. (OR:3.59, 95%CI:1.11-11.68). Gender difference, BMI categorized as overweight (25.0e29.9 kg/m3) or obese (30 kg/m3) compared to normal (18.5e24.9 kg/m3), duration of surgery 90 min compared to < 90 min, and duration of tourniquet application 60 min compared to < 60 min did not show a significantly higher risk for DVT. The distribution of DVT-positive and -negative populations in each generation is summarized in Fig. 1. A third of our study population consisted of patients under 20 years of age. Note the lower incidence of DVT in this age group. 4. Discussion The most important findings of this study was that 18 out of 256 patients developed DVT after arthroscopically assisted ACLR by using duplex ultrasound performed on postoperative day 7. The total incidence of 6.6% from our results was lower compared to that of the 14% detected by venography that was reported by Ye et al. [9] Our results included 64 patients aged < 18 years that were excluded in the study by Ye et al., and these patients consisted of a fourth of our study population. Taking the lower incidence of DVT in this age group into consideration as shown in Fig. 1, this discrepancy may not be a result of the difference in diagnostic accuracy between venography and duplex ultrasound, but rather the difference in the study population. As Grady-Benson et al. [12] suggested, the diagnostic accuracy of duplex ultrasound is almost equal to that of venography. In addition, the great advantage of ultrasonography lies in its safety and noninvasiveness that can be facilitated across all generations; therefore, it has been widely recognized as a primary modality for diagnosis and exclusion of acute DVT in recent years [10]. On the other hand, compared to other reports relating the incidence or prevalence of DVT after arthroscopic intraarticular knee surgery [1,2], our results showed a relatively higher incidence that were comparable to those reported by Jaureguito et al. [11] This may be partly due to extra-articular surgical invasion such as
3
graft harvest, but the postoperative immobilization period may exert a greater influence. Although there is no consensus on the immobilization period after ACLR, immobilization seems to induce a positive effect against the initial tunnel enlargement, especially for hamstrings graft ACLR [13]. Packer et al. reported that immobilization enhance graft tunnel healing/anchoring rather than immediate rehabilitation [14]. We had mostly agreed these opinions, so we set a 2-week immobilization period in our postoperative rehabilitation program. In our series of 136 patients who received venous ultrasonography on both postoperative days 7 and 14, five DVT that included one proximal and one large distal thrombus were surprisingly detected on postoperative day 14. To our knowledge, this is the first report of duplex ultrasound DVT screening performed twice between perioperative periods after ACLR. This suggested that prolonged immobilization increases the risk of developing large DVT that may lead to PE and demonstrated the necessity of DVT screening when prolonged immobilization is anticipated. Gaskill et al. [15] investigated 15,756 cases of ACLR from the US Military Healthcare System database and reported that the prevalence of symptomatic DVT was as low as 0.53%, but risk was increased in patients aged 35 years, patients with a history of nicotine use, and patients undergoing concomitant high tibial osteotomy or concomitant PCLR. In our study, symptomatic DVT was detected in two cases out of 256 patients (0.78%), and most of the DVT cases were asymptomatic. However, we warn that these asymptomatic DVT cases contained one proximal and five distal large DVT that could potentially progress to proximal DVT without anticoagulant treatment. In terms of potential risk factors, our series showed that patients aged 30 years have a significantly higher risk of developing DVT (P ¼ 0.03), which maintains consistency with the past literatures. Our series excluded concomitant procedures, but surgical factors such as duration of surgery 90 min and duration of tourniquet application 60 min did not increase the risk for DVT. 4.1. Limitations There are some limitations of this study. First, we did not perform preoperative duplex ultrasonography. Patients with positive DVT may have included those who had a preoperative onset of DVT during the waiting period following their injury or those who had DVT prior to their ACL injury. Secondly, asymptomatic PE could have been overlooked, since PE was not screened by contrast CT unless proximal DVT was confirmed. In addition, post-discharge follow-up by ultrasonographic examination was only performed on DVT positive patients in order to confirm the disappearance of thrombi after oral anticoagulant
Table 1 Multivariate Analysis of Risk Factors for DVTa at Postoperative day 7. Variables of Interest
Reference Category (DVT þ/n)e
Gender Age Group BMIb Category
Men (10/129) Age<30 years old (4/140) <25 (normal) (11/196)
Duration of Operation Duration of Tourniquet Application
<90 min (9/183) <60 min (11/190)
a b c d e
Comparator Category (DVT þ/n)
Women (6/127) Age30 years old (12/116) 25 (overweight, obese) (5/60) 90 min (7/73) 60 min (5/66)
DVT ORc(95%CId)
P-Value
0.76 (0.26e2.27) 3.59 (1.11e11.68) 1.40 (0.43e4.50)
0.63 0.03 0.57
2.61 (0.65e10.41) 0.64 (0.15e2.75)
0.18 0.55
DVT: deep venous thrombosis. BMI: body mass index. OR: Odds Ratio. CI: Confidence Interval. (number of DVT positive patient/total number of patient).
Please cite this article as: Oshiba H et al., The incidence and risk factor of deep venous thrombosis after arthroscopically assisted anterior cruciate ligament reconstruction, Journal of Orthopaedic Science, https://doi.org/10.1016/j.jos.2019.05.014
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H. Oshiba et al. / Journal of Orthopaedic Science xxx (xxxx) xxx
Table 2 Multivariate Analysis of Risk Factors for DVTa at Postoperative day 14. Variables of Interest
Gender Age Group BMIb Category Duration of Operation Duration of Tourniquet Application
Reference Category (DVTþ/n)e
Men (1/64) Age<30 years old (0/75) <25 (normal) (2/100) <90 min (5/112) <60 min (5/116)
Comparator Category (DVTþ/n)
Women (4/72) Age30 years old (5/61) 25 (overweight, obese) (3/36) 90 min (0/24) 60 min (0/20)
DVT ORc(95%CId)
P-Value
4.78 (0.48e47.51) * 2.94 (0.42e20.55)
0.18 0.28
* Blank in the table: impossible to calculate. a DVT: deep venous thrombosis. b BMI: body mass index. c OR: Odds Ratio. d CI: Confidence Interval. e (Number of DVT positive patient/total number).
Acknowledgments The authors thanks fot Dr. Shota Ikegami for his statistical advice, and for Mr. Sho Steven Sugita for his English editorial assistance. References
Fig. 1. Distribution of DVT Positive þ/Negative- Population in Each Age Group. The black and white numbers in the bar represent the number of DVT positive and negative patients, respectively.
therapy. Therefore, the onset of asymptomatic DVT after hospital discharge could possibly be overlooked; however, we believe that a new onset of DVT would be extremely rare when the immobilization period of the affected is complete, weight-bearing exercises are started, and as a result, the stagnated blood flow in the lower limbs is relieved. Lastly, we could not conduct interrater reliability and test-retest reliability for duplex ultrasound technique among three technicians, thus the result may potentially suffer interrater variability among them.
5. Conclusions The incidence of DVT after ACLR detected by duplex ultrasound on postoperative day 7 was 6.6%. Postoperative management consisting of a 2-week immobilization may have triggered the detection of five additional DVT cases out of 136 patients on postoperative day 14. Age 30 years has a potentially higher risk for developing DVT. Great care for DVT should be taken if prolonged immobilization is applied after ACLR surgery.
Conflict of interest All the authors have nothing to disclose.
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Please cite this article as: Oshiba H et al., The incidence and risk factor of deep venous thrombosis after arthroscopically assisted anterior cruciate ligament reconstruction, Journal of Orthopaedic Science, https://doi.org/10.1016/j.jos.2019.05.014