Venous thromboembolism in patients undergoing shoulder surgery: Findings from the RECOS Registry Davide Imberti, Nicola Ivaldo, Luigi Murena, Paolo Paladini, Alessandro Castagna, Giovanni Barillari, Enrico Guerra, Giuseppe Fama, Filippo Castoldi, Bruno Marelli, Matteo Giorgi Pierfranceschi, Giuseppe Camporese, Francesco Dentali, Giuseppe Porcellini PII: DOI: Reference:
S0049-3848(14)00279-5 doi: 10.1016/j.thromres.2014.05.014 TR 5524
To appear in:
Thrombosis Research
Received date: Revised date: Accepted date:
23 December 2013 22 April 2014 12 May 2014
Please cite this article as: Imberti Davide, Ivaldo Nicola, Murena Luigi, Paladini Paolo, Castagna Alessandro, Barillari Giovanni, Guerra Enrico, Fama Giuseppe, Castoldi Filippo, Marelli Bruno, Pierfranceschi Matteo Giorgi, Camporese Giuseppe, Dentali Francesco, Porcellini Giuseppe, Venous thromboembolism in patients undergoing shoulder surgery: Findings from the RECOS Registry, Thrombosis Research (2014), doi: 10.1016/j.thromres.2014.05.014
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ACCEPTED MANUSCRIPT VENOUS THROMBOEMBOLISM IN PATIENTS UNDERGOING FINDINGS FROM THE RECOS REGISTRY
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SHOULDER SURGERY:
Davide Imberti 1, Nicola Ivaldo 2, Luigi Murena 3, Paolo Paladini 4, Alessandro Castagna 5,
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Giovanni Barillari 6, Enrico Guerra 7, Giuseppe Fama 8, Filippo Castoldi 9, Bruno Marelli 10, Porcellini 4, for the RECOS Investigators.
Ospedale, Piacenza,
Varese,
4
2
Casa di Cura Villa Igea, Acqui Terme (AL),
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1
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Matteo Giorgi Pierfranceschi 1, Giuseppe Camporese 8, Francesco Dentali
3
3,
Università Insubria,
Unit of Shoulder Surgery – D. Cervesi Hospital - Cattolica,(RN),
Humanitas, Rozzano (MI),
Azienda Ospedaliero-Universitaria, Udine, 9
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8
6
Bologna, Università, Padova, Ospedale Mauriziano, Torino,
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Italy.
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Address for correspondence: Dr. Davide Imberti
Haemostasis and Thrombosis Center Internal Medicine Department Piacenza Hospital, Via Taverna 49, 29121 Piacenza, Italy Phone: +39-0523-302578 Fax: +39-0523-302595 E-mail: [email protected]
1
10
Giuseppe
7
5
Centro
Istituto Rizzoli,
Istituto Pini, Milano; all in
ACCEPTED MANUSCRIPT SUMMARY Background: Limited informations are available about venous thromboembolic (VTE) complications and thromboprophylaxis use after shoulder surgery. The primary end-point
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of the study was to determine the incidence of symptomatic deep vein thrombosis (DVT)
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and thromboprophylaxis practices were also studied.
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and pulmonary embolism (PE) within 90 days after shoulder surgery. Risk factors for VTE
Methods: RECOS is a prospective multicenter registry of consecutive patients undergoing shoulder surgery recruited in nine hospitals in Italy.
Cumulative rates of VTE were
estimated according to the Kaplan-Meier method; a Cox regression model was used to
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calculate adjusted hazard ratio (HR) and 95% confidence interval (CI) for some variables that were identified as risk factors for VTE.
were enrolled.
patients (males 54.4%; mean age 55,65
The surgical procedures were: arthroscopy (71.9%),
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±15.3 years)
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Results: From June 2009 to June 2011 1366
hemiarthroplasty (17.2%) total replacement (8.9%), fixation for proximal humeral fracture (2%). After 90 days, the incidence
of symptomatic VTE was 0.66 % (95CI% 0.2-1.12).
Mean age was significantly higher in patient with than in patients without VTE (67,1+/3.49
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years vs 55,6+/-0,42 years, respectively; p= 0.024). Duration of surgery > 60 minutes (HR:10.99; 95CI% 1.26-95.89; p=0.030) was found as independent risk factor for VTE, while cancer, medical disease, venous insufficiency and previous VTE were not. Pharmacological thromboprophylaxis was prescribed in 33.5% (n=457) of the patients, in 95.8 % of whom for a duration > 10 days. Conclusions: The risk of symptomatic VTE in patients undergoing shoulder surgery is low. The potential need for thromboprophylaxis should be based on a case by case evaluation.
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ACCEPTED MANUSCRIPT INTRODUCTION Hip and knee major surgery represent a risk factor for venous thromboembolism (VTE) (1, 2). The incidence of VTE after hip and knee arthroplasty or surgery for hip fracture
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without prophylaxis ranges from 29% to 60% for deep vein thrombosis (DVT) and from 1%
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to 3% for fatal pulmonary embolism (PE) (1-3). Consequently, on the grounds of the
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available literature, thromboprophylaxis in patients undergoing maior orthopedic surgery of the lower limb is strongly recommended by experts and international consensus guidelines (3). On the contrary, several independent, retrospective and well done observational studies have reported a quite low VTE rate in shoulder surgery; moreover, few
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informations are available about the need for thromboprophylaxis (if any) in this clinical setting (4-9). To the best of Authors’ knowledge, the incidence and risk factors for VTE in
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shoulder surgery haven’t been investigated with prospective epidemiological studies. The
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primary objective of the present prospective cohort registry is to report on the occurrence of symptomatic VTE following different type of shoulder surgery. Risk factors for VTE and
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thromboprophylactic practices in this surgical population have been also analyzed.
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ACCEPTED MANUSCRIPT MATERIALS AND METHODS The objective of the RECOS registry was to obtain clinical information on VTE in a large
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cohort of unselected patients undergoing shoulder surgery in Italy.
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Patients
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The RECOS registry included consecutive patients, aged 18 years or older, undergoing different type of open and arthroscopic shoulder surgery: cuff repair, shoulder instability, shoulder replacement, hemiarthroplasty, total anatomical arthroplasty, total
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reverse arthroplasty, shoulder fractures. Nine Italian centers participated in the registry. Exclusion criteria were pregnancy, lactating, declared inability to partake to the scheduled follow up visits, consent denial. No subject could be included twice. The Ethical
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Committee of the participating centres ratified the study protocol. A written informed
Data collection
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consent was obtained in all cases.
Clinical data at the time of surgery and at planned follow-up visits were entered in
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an electronic network. Patient information was obtained by the study coordinator using the electronic case report form and submitted to a data management centre through a secured website. A progressive number has been assigned to each patient in every study centre to permit identification of the subject while protecting personal identity, that was treated as a confidential information. All electronic data with confidential information were secured by passwords and all paper charts were securely stored in convenient spaces at the participating hospitals. Quality of data was applied during the data entry by electronic control. Queries were sent to the local investigator in case of inconsistency.
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ACCEPTED MANUSCRIPT Collected patient information At the time of surgery demographic characteristics, type and duration of surgery,
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type of anaesthesia, patient position, laboratory test (haemoglobin, platelet count, creatinine, transaminases), concomitant medications, prophylaxis for VTE were recorded.
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Known risk factors for VTE like ongoing neoplastic disease, known thrombophilia, previous
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VTE, venous insufficiency, severe medical diseases were registered. Recent surgery or trauma, immobilization, oral contraceptives, hormonal replacement therapy were also collected as temporary risk factors for VTE. To reflect routine medical practice, the
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decision to initiate thromboprophylaxis (as well as type, dose and duration) was left to the investigators; no specific recommendations were given. After inclusion in the RECOS registry, all patients were evaluated in the out-patient In addition, telephone contacts were scheduled at 90 days.
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clinic after 7 and 30 days.
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Any sign or symptom of VTE were reported. In case of clinical suspicion of DVT or PE, an objective imaging testing was required to confirm the diagnosis (for DVT: compressive ultrasonography, Echocolordoppler, computed tomography scan, venography; for PE:
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perfusion lung scan matched with chest X-ray, ventilation/perfusion scan, computed tomography, angiography. A clinical-events committee whose members were unaware of any information regarding the patients (i.e.
risk factors for VTE,
use of
thromboprophylaxis) adjudicated all components of the clinical end-points (DVT, PE). In case of patient death, date and cause were registered. Information about antithrombotic prophylaxis was also recorded. The study protocol did not dictate any interference with patient management. The choice of diagnostic methods and treatment of the VTE event were left to the attending physicians in the participating centers.
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ACCEPTED MANUSCRIPT Data analysis Cumulative rates of DVT or PE events were estimated according to the Kaplan–Meier
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method, in which data from patients who did not displayed any events where censored at the last follow-up visit. We used the life-table method to determine cumulative event
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probabilities. Median time of follow-up at the first and the third visit were also calculated by
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Kaplan-Meier method.
Differences among patient categories were computed by Contingency Tables and Significance assessed by Chi-Square Test. Differences between continuous variables
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were assessed by student t test. The most relevant variables were included in a Cox proportional regression model in order to estimate the hazard ratios and 95% confidence intervals (CI) of DVT or PE events.
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Variables considered for adjustment in Cox regression analysis were age, gender, BMI,
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length of the intervention (< 60 min or > 60 min), use of prophylaxis, type of surgery. Subsequently, to assess the impact of permanent risk factors for VTE in this setting, cancer, medical disease, venous insufficiency and previous VTE were introduced in the
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model. Known thrombophilia was not considered since this information was collected only in a small number of patients.
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ACCEPTED MANUSCRIPT SOURCE OF FUNDING The Italian RECOS Registry was supported by an unrestricted educational grant from
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Bayer-Schering; the pharmaceutical company had no role in analyzing the data or
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preparing the manuscript.
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ACCEPTED MANUSCRIPT RESULTS Baseline patient and surgery characteristics
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From June 2009 to June 2011 1378 consecutive patients were included in the registry.
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The analysis population consisted of 1366 evaluable patients (54.4% males), 12 patients ( 0.9%) patients being excluded due to a major protocol violation; the reasons for exclusion
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were absence of follow-up visit (11 patients) and refusal of informed consent (1 patient). The mean age of the study population was 55.65 ±15.3 years (range 18-88 years); males were significantly younger than females (mean age 51.25 ±15.9 versus 60.89 ±12.7 years, The shoulder surgical procedures were the following:
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respectively; p< 0.001).
arthroscopy (71.9%), hemiarthroplasty (17.2%) total replacement (8.9%), fixation for
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proximal humeral fracture (2%). The main concomitant risk factors for VTE were medical comorbidities (heart failure, respiratory failure), venous insufficiency and previous VTE.
anesthesia are
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The description of demographic characteristics, risk factors for VTE, type of surgery and reported in Table 1.
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Thromboprophylaxis
During hospitalization, thromboprophylaxis was initiated in 34.1 % of the patients (n=461) (Table 2). Pharmacological thromboprophylaxis was prescribed in the majority of the cases (n= 457; 33.5%); this was a low-molecular-weight heparin in 98.2% (n = 450), unfractionated heparin in 0.5% (n = 2), antiplatelet therapy in 0.3% (n = 1), other anticoagulants in 1% (n = 4) of the patients, respectively. Pharmacological prophylaxis was started pre-operatively in 75 patients (18.6%), peri-operatively in 42 patients (10.4%), post-operatively in 286 patients (71%), respectively;
in the remaining 54 patients no
informations about initiation of thromboprophylaxis were available. The dose of the lowmolecular-weight heparin used was prophylactic (< 5700 UI/once daily) in 448 out of 450 8
ACCEPTED MANUSCRIPT patients (99.5%). Mechanical prophylaxis was used in
4 patients only (alone in two
patients, in combination with anticoagulation in two patients). Prophylaxis was prescribed
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significantly less frequently in patients undergoing arthroscopy (n=209; 21.3%) than in patients undergoing other surgical procedures (n=251; 65.3%) (p 10 days. The adherence during follow-up to the prescribed prophylaxis was 92.7% after 7 days and 76.3% after 30 days, respectively. The rate of VTE in patients undergoing and not undergoing thromboprophylaxis was
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0.86% (4/461) and 0.55% (5/905), respectively. No significative association was found about the risk of VTE and the use of thromboprophylaxis (Table 3).
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Venous thromboembolism
After 90 days of follow-up 9 patients suffered of symptomatic VTE, resulting a cumulative
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incidence rate of 0.66 % (95CI% 0.2-1.12) (Figure 1). Six patients suffered from lower limb DVT (in five patients proximal, in one patient distal) and two from upper limb DVT. (Table 3). One patient had symptomatic, not fatal PE. to event was 46 days (range 21-90 days).
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surgery
The median time (range) from The diagnosis was confirmed by
imaging techniques in all the cases of DVT (compressive ultrasonography in three cases, Echocolordoppler in five cases), and by clinical suspicion of PE.
computed lung tomography in the patient with
In other 8 patients the clinical suspicion of VTE
was not
confirmed by the clinical-event central committee: in the seven patients with suspected lower limb DVT final diagnosis was superficial phlebitis (five patients) and erysipela (two patients), while in the only one with suspected PE final diagnosis was pneumonia.
No
patients died at the end of follow-up. When the study sample was categorized into a priori risk groups as perceived by the clinicians basing on the type of surgery , the incidence of VTE
was six-fold higher
in patients undergoing total replacement (1.7%) or
hemiarthroplasty (1.7%) than in patients undergoing arthroscopy (0.3%) (Table 4). Mean 9
ACCEPTED MANUSCRIPT age was significantly higher in patient with than in patients without VTE (67.1+/3.49 years vs 55.6+/-0.42 years, respectively; p= 0.024). Co-variates included in the multivariate
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logistic regression analysis and relative HR are shown in Table 4; duration of surgery > 60 minutes (HR:10.99; 95CI% 1.26-95.89; p=0.030) was found as the only independent risk
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factor for VTE. When the presence of known permanent risk factors for VTE (cancer,
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medical disease, venous insufficiency and previous VTE) was introduced in the model, none of these factors resulted significantly associated with an increased risk of VTE and the magnitude of association with duration of surgery > 60 minutes was not significantly
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affected (HR 13.14; 95%CI 1.55-111.72). Thromboprophylaxis was prescribed only in four out of the nine patients who experienced VTE complications (in all cases LMHWs at prophylactic dose); of interest, in all of them VTE occurred after discontinuation of heparin
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administration.
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ACCEPTED MANUSCRIPT DISCUSSION This is the first observational, prospective, multicenter registry study that investigates the
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risk of DVT and PE in patients undergoing shoulder surgery. In the present population the incidence rate of symptomatic VTE confirmed with imaging techniques was about 0.7% at
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3 months. This figure is comparable to those previously reported in large retrospective
rigorous clinical studies
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observational studies (5-7). As far as we know, no large prospective, methodologically have evaluated the real incidence and risk factors of VTE
complications in shoulder surgery and the figures reported in the literature are quite
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different. For example in a small study, Willis et al (10) prospectively followed up at their institute 100 shoulder arthroplasty patients undergoing mandatory upper and lower limb vein ultrasonographic evaluation and found a Doppler-proven DVT rate of 13% after the
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procedure; three patients (3%) had symptomatic PE (in one patient fatal). Moreover,
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Lyman (5) analyzed the New York State Hospital admissions database over a 18-year period, showing after 13759 shoulder arthroplasties a symptomatic PE rate of 0.23% and a DVT rate of 0.5%, respectively. Increasing age, cancer and trauma were the most
VTE
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important risk factors. However, this study has several limitations: the real incidence of is certainly higher, since the available data only reflect
patients in whom the
diagnosis of DVT or PE was performed before discharge from hospital; no informations about the location of the thrombus (upper or lower limb) or the use of thromboprophylaxis are available; the methods for confirming DVT or PE is unknown. large retrospective studies using administrative database
On the contrary, two
have recently reported a low
incidence of VTE in patients undergoing shoulder surgery (6,7). Sperling (6) enrolled in a single-center study in USA 2885 consecutive patients who underwent primary shoulder arhtroplasty between June 1981 and June 2001; during this time period, five patients suffered from acute symptomatic PE (0.17%). Of interest, the length of follow-up after surgery was very short (one week only) and no informations were given about use of VTE 11
ACCEPTED MANUSCRIPT prophylaxis.
Jameson analyzed data of the UK national database for a 42-month period
for planned shoulder surgery (7). Within 90 days after surgery, VTE rate was as follows:
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for total shoulder replacement (4061 patients) 0.2%, for arthroscopic procedures (65302 patients) 0.01%, for hemiarthroplasty (6168 patients) 0.13%, for proximal humeral fracture
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surgery (4696 patients) 0.39%, respectively. The incidence of VTE is certainly under-
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estimated in this study, since only VTE events occurring during surgical admission or requiring hospitalization within 90 days after surgery have been recorded; no data are available about out-patients diagnoses of DVT or PE. Finally, Randelli et al published the
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results of an Italian multicentric study assessing the number of DVT after shoulder arthroscopy occurring in the years 2005 and 2006 (9). During this period, six patients had DVT over a total of 9285 different arthroscopic procedures (0.08%). Moreover, several
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reports of DVT (both upper and lower limb) as well as of PE (fatal and not fatal) have
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been published in patients undergoing shoulder surgery (11-19).
In our study, main permanent risk factors as cancer, previous VTE, venous insufficiency and medical diseases were not associated with an increased risk of VTE; this conclusion
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should be interpretated with caution , since the low rate of thrombosis reported in our study and the small number of patients with such major risk factors. On the contrary, as reported in previous studies (5,7), our data show that open surgery (including total replacement and hemiarthroplasty) and age are factors associated with a higher risk for development of VTE complications; to our knowledge, in our registry for the first time the long duration of intervention (> 60 minutes) was
identified as an independent risk factors for VTE in
shoulder surgery. The fact that these risk factors are similar to those identified for other surgical and medical patients supports the relevance of risk-based thromboprophylaxis guidelines developed on a personal basis.
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ACCEPTED MANUSCRIPT About one-third of subjects were prescribed a thromboprophylactic treatment, mainly with LMWHs (98%) at prophylactic dose and started post-operatively in about 70 % of the
days. Prophylaxis was prescribed
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cases; in most of the patients (95%) the recommended duration of prophylaxis was > 10 less frequently in patients undergoing arthroscopy
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(about 20%) than in patients undergoing other surgical procedures (about 65%); in our
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series, type of surgery (open versus arthroscopic procedures) was the main driver for prescription of thrombopropylaxis. Finally, no significative association was found about the risk of VTE and the use of thromboprophylaxis. These figures are very interesting, since
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to our knowledge detailed informations about daily clinical practice of VTE prophylaxis in shoulder surgery (including type, dose, duration and timing) have never been published before.
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Even if the design of our study (observational registry), as well as the low number of
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symptomatic VTE events do not allow clear cut conclusions about the potential role of prophylaxis in reducing the risk of VTE in this clinical setting, it seems reasonable to suggest a careful stratification of the patients based both on the personal risk factors and
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on the type of surgery. Our data clearly show that open surgery (including total replacement and hemiarthroplasty), long duration of intervention (> 60 minutes) and age are factors associated with a higher risk for developement of VTE complications; thus, in these conditions perioperative antithrombotic prophylaxis may be beneficial.
On the
other hand, our study confirms that shoulder arthroscopy carries a very low risk of VTE, similar to the known population background risk; thus, in this subgroup of patients thomboprophylaxis may not be required. Our study has several limitations. First, the observed rate of VTE may represent a lower estimate of the actual rate, as about a third of subjects received pharmacological thromboprophylaxis, mainly LMWHs which have been demonstrated to significantly reduce the risk of
VTE in different surgical and medical patients (3,10,11); moreover, 13
we
ACCEPTED MANUSCRIPT included only symptomatic and not asymptomatic ultrasound detected DVT
to closely
reflect routine practice. Second, approximately 50% of the suspected symptomatic events
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were not confirmed by the central event committee; however, an objective imaging test was required by the protocol of the study for confirmation of DVT or PE. Third, it is
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possible that the prescribing practices of thrombophylaxis of orthopaedic surgeons may
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have been modified by their participation in the study, even if decision to initiate thromboprophylaxis (as well as type, dose and duration) was left to the investigators and no specific recommendations were given by the protocol of the study.
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However, the strength of this study was the high number of included patients with 3months follow-up. Contemporary studies
about
VTE in shoulder surgery
are
retrospective and have used administrative databases for research (5,7) or have been
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performed in a single center (6). RECOS is a clinical, prospective, multicenter registry risk factors and use
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specifically designed to assess to incidence of symptomatic VTE, of thromboprophylaxis
in an unselected population of consecutive patients undergoing
different type of shoulder surgery. Given its structure and design, RECOS is likely to
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provide informations that are more generalizable than that achieved from retrospective studies carried out basing on administrative data. In conclusion, our registry shows that the rate of symptomatic VTE in patients undergoing shoulder surgery is quite low. Thus, thromboprophylaxis is not mandatory and its use should be based on a case by case evaluation by orthopaedic surgeons.
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ACCEPTED MANUSCRIPT REFERENCES 1. Ageno W, Squizzato A, Garcia D, Imberti D. Epidemiology and risk factors of
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venous thromboembolism. Semin Thromb Hemost 2006; 32:651-8 2. Imberti D, Bianchi C, Zambon A, et al. Venous thromboembolism after major
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orthopaedic surgery: a population-based cohort study. Intern Emerg Med 2012;7
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(3):243-9.
3. Falck-Ytter Y,; Francis CW, Johanson N, et al. Prevention of VTE in Orthopedic Surgery Patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed:
Chest 2012; e278S-e325S.
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American College of Chest Physicians Evidence-Based Clinical Practice Guidelines
4. Blom JW, Doggen CJ, Osanto S, Rosenthal FR. Old and new risk factors for upper
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limb deep vein thrombosis. J Thromb Haemost 2005;3:2471-8.
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5. Lyman S, Sherman S, Carter TI, et al. Prevalence and risk factors for symptomatic thromboembolic events after shoulder arthroplasty. Clin Orthop Relat Res 2006;448:152-6.
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6. Sperling JW, Cofield RH. Pulmonary embolism following shoulder arthroplasty. J Bone Joint Surg Am 2002;84-A(11):1939-41. 7. Jameson S, James P, Howcroft D, et al. Venous thrombolic events are rare after shoulder surgery: analysis of a national database. J Shoulder Elbow Surg 2011;20:764-770. 8. Garofalo R, Notarnicola A, Moretti L, et al. Deep vein thromboembolism after arthroscopy of the shoulder: two case reports and a review of the literature. BMC Musculoskeletal Disorders 2010;11:65-73. 9. Randelli P, Castagna A, Cabitza F, et al. Infectious and thromboembolic complications of arthroscopic shoulder surgery. J Shoulder Elbow 2009;3:123-126.
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ACCEPTED MANUSCRIPT 10. Willis AA, Fealy S, Warren RF, et al.
Deep vein thrombosis following
reconstructive shoulder arthroplasty: a prospective observational study. J Shoulder
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Elbow Surg 2007; 16:e46. 11. Saleem A, Markel DC. Fatal pulmonary embolus after shoulder arthroplasty. J
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Arthroplasty. 2001;16:400-3.
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12. Walper JJ, Markel DC. Upper extremity deep venous thrombosis leading to pulmonary embolism after total hip arthroplasty. J Arthroplasty 2001;16:124-7. 13. Burkhart SS. Deep venous thrombosis after shoulder arthroscopy. Arthroscopy
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1990;6:61-3.
14. Willis AA, Verma NN, Thornton SJ, et al. Upper-extremity deep-vein thrombosis after anterior shoulder dislocation and closed reduction. A case report. J Bone Joint
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Surg Am 2005 ;87:2086-90.
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15. Polzhofer GK, Petersen W, Hassenpflug J. Thromboembolic complication after arthroscopic shoulder surgery. Arthroscopy 2003;19:E16-9. Review. 16. Weber SC, Abrams JS, Nottage WM. Complications associated with arthroscopic
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shoulder surgery. Arthroscopy 2002;18(2 Suppl 1):88-95. 17. Creighton RA, Cole BJ. Upper extremity deep venous thrombosis after shoulder arthroscopy: A case report. J Shoulder Elbow Surg 2007;16:e20-22. 18. Amarasekera SS, van Dalen J, Thompson TJ, Osman M. Pulmonary embolism after an acromioplasty an rotator cuff repair. J Shoulder Elbow Surg 2008. In print. 19. Cortés ZE, Hammerman SM, Gartsman GM. Pulmonary embolism after shoulder arthroscopy: Could patient positioning and traction make a difference? J Shoulder Elbow Surg 2007; 16:e16-17.
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ACCEPTED MANUSCRIPT LEGEND FIGURE 1: Cumulative incidence of VTE in the study population
TABLE 2: Rate of thromboprophylaxis in the study population
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TABLE 3: Multivariate analysis of risk factors of VTE event
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TABLE 1: Demographic and clinical features of the analysed population (n = 1366)
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TABLE 4: Comparison of different type of shoulder surgery for risk of VTE
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Figure 1
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Age (years), median (range)
55.65 ±15.3 (18-88)
Male gender n (%)
743 (54.4)
BMI
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≥ 30 n (%)
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160 (11.7)
1206 (88.3)
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< 30 n (%)
Permanent known risk factors for VTE
Medical disease n (%)
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Venous insufficiency n (%)
Known thrombophilia n (%)
Previous VTE n (%)
66 (4.8)
8 (0.6)
10 (0.8)
16 (1.2)
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Temporary known risk factors for VTE
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Cancer n (%)
153 (11.2)
Recent (< 3 months) surgery or trauma
26 (1.9)
Immobility (< 7 days)
9 (0.7)
17 (1.7)
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Oral contraceptives
Hormonal replacement therapy
8 (0.8)
Surgery
Type
Arthroscopy n (%)
982 (71.9)
Hemiarthroplasty n (%)
235 (17.2)
Total replacement n (%)
121 (8.9)
Fixation for proximal humeral fracture n (%)
28 (2)
Duration
≤ 60 minutes n (%)
931 (68.2)
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ACCEPTED MANUSCRIPT > 60 minutes n (%)
435 (31.8)
Position of the patient
173 (12.7)
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Supine decubitus
896 (65.6)
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Beach chair decubitus n (%)
53 (3.9)
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Lateral decubitus n (%)
Lateral decubitus with traction n (%)
Anesthesia
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Local n (%) Loco-regional n (%) General n (%)
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Table 1
1 (0.1) 202 (15.2) 260 (19) 902 (65.9)
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Combined n (%)
243 (17.8)
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33.5
Mechanical
2
0.3
Both
2
0.3
None
905
65.9
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Pharmacological
%
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Table 2
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Number of patients (n = 1366) 457
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Type of thromboprophylaxis
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95%CI*
P value
Male
1.7
0.3 – 9.6
0.504
Age
1.0
0.9 - 1.1
0.081
BMI > 30
0.9
0.7-1.1
Duration of surgery > 60 minutes
10.99
1.26-95.89
Use of thromboprophylaxis
0.493
0.1-2.2
2.3
0.2-23.3
0.314 0.030
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Other surgery **
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Hazard Ratio
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Risk factor
* confidence intervals ** arthroscopy as reference group
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Table 3
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0.359 0.469
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N = 982
N = 235 Rate n %
N = 121 Rate n %
1 0 1
0.85
1
n
3 1 2
1.27
Upper limb DVT
0
0
1
0.43
Pulmonary embolism
1
0.1
0
0
Any VTE events
3
0.3
4
Death
0
0
0
All shoulder surgery
N = 1366 Rate n %
0
6
0.45
0.85
0
0
2
0.14
0
0
0
0
1
0.07
1.7
2
1.7
0
0
9
0.66
0
0
0
0
0
0
0
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Table 4
Fixation for proximal humeral fracture N = 28 Rate n %
0
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2 0 2
0.2
Distal DVT Proximal DVT
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Lower limb DVT
Rate %
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Outcome
Total replacement
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Hemiarthroplasty
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Arthroscopy
23
S0049-3848(14)00279-5 doi: 10.1016/j.thromres.2014.05.014 TR 5524
To appear in:
Thrombosis Research
Received date: Revised date: Accepted date:
23 December 2013 22 April 2014 12 May 2014
Please cite this article as: Imberti Davide, Ivaldo Nicola, Murena Luigi, Paladini Paolo, Castagna Alessandro, Barillari Giovanni, Guerra Enrico, Fama Giuseppe, Castoldi Filippo, Marelli Bruno, Pierfranceschi Matteo Giorgi, Camporese Giuseppe, Dentali Francesco, Porcellini Giuseppe, Venous thromboembolism in patients undergoing shoulder surgery: Findings from the RECOS Registry, Thrombosis Research (2014), doi: 10.1016/j.thromres.2014.05.014
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT VENOUS THROMBOEMBOLISM IN PATIENTS UNDERGOING FINDINGS FROM THE RECOS REGISTRY
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SHOULDER SURGERY:
Davide Imberti 1, Nicola Ivaldo 2, Luigi Murena 3, Paolo Paladini 4, Alessandro Castagna 5,
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Giovanni Barillari 6, Enrico Guerra 7, Giuseppe Fama 8, Filippo Castoldi 9, Bruno Marelli 10, Porcellini 4, for the RECOS Investigators.
Ospedale, Piacenza,
Varese,
4
2
Casa di Cura Villa Igea, Acqui Terme (AL),
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1
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Matteo Giorgi Pierfranceschi 1, Giuseppe Camporese 8, Francesco Dentali
3
3,
Università Insubria,
Unit of Shoulder Surgery – D. Cervesi Hospital - Cattolica,(RN),
Humanitas, Rozzano (MI),
Azienda Ospedaliero-Universitaria, Udine, 9
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8
6
Bologna, Università, Padova, Ospedale Mauriziano, Torino,
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Italy.
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Address for correspondence: Dr. Davide Imberti
Haemostasis and Thrombosis Center Internal Medicine Department Piacenza Hospital, Via Taverna 49, 29121 Piacenza, Italy Phone: +39-0523-302578 Fax: +39-0523-302595 E-mail: [email protected]
1
10
Giuseppe
7
5
Centro
Istituto Rizzoli,
Istituto Pini, Milano; all in
ACCEPTED MANUSCRIPT SUMMARY Background: Limited informations are available about venous thromboembolic (VTE) complications and thromboprophylaxis use after shoulder surgery. The primary end-point
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of the study was to determine the incidence of symptomatic deep vein thrombosis (DVT)
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and thromboprophylaxis practices were also studied.
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and pulmonary embolism (PE) within 90 days after shoulder surgery. Risk factors for VTE
Methods: RECOS is a prospective multicenter registry of consecutive patients undergoing shoulder surgery recruited in nine hospitals in Italy.
Cumulative rates of VTE were
estimated according to the Kaplan-Meier method; a Cox regression model was used to
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calculate adjusted hazard ratio (HR) and 95% confidence interval (CI) for some variables that were identified as risk factors for VTE.
were enrolled.
patients (males 54.4%; mean age 55,65
The surgical procedures were: arthroscopy (71.9%),
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±15.3 years)
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Results: From June 2009 to June 2011 1366
hemiarthroplasty (17.2%) total replacement (8.9%), fixation for proximal humeral fracture (2%). After 90 days, the incidence
of symptomatic VTE was 0.66 % (95CI% 0.2-1.12).
Mean age was significantly higher in patient with than in patients without VTE (67,1+/3.49
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years vs 55,6+/-0,42 years, respectively; p= 0.024). Duration of surgery > 60 minutes (HR:10.99; 95CI% 1.26-95.89; p=0.030) was found as independent risk factor for VTE, while cancer, medical disease, venous insufficiency and previous VTE were not. Pharmacological thromboprophylaxis was prescribed in 33.5% (n=457) of the patients, in 95.8 % of whom for a duration > 10 days. Conclusions: The risk of symptomatic VTE in patients undergoing shoulder surgery is low. The potential need for thromboprophylaxis should be based on a case by case evaluation.
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ACCEPTED MANUSCRIPT INTRODUCTION Hip and knee major surgery represent a risk factor for venous thromboembolism (VTE) (1, 2). The incidence of VTE after hip and knee arthroplasty or surgery for hip fracture
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without prophylaxis ranges from 29% to 60% for deep vein thrombosis (DVT) and from 1%
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to 3% for fatal pulmonary embolism (PE) (1-3). Consequently, on the grounds of the
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available literature, thromboprophylaxis in patients undergoing maior orthopedic surgery of the lower limb is strongly recommended by experts and international consensus guidelines (3). On the contrary, several independent, retrospective and well done observational studies have reported a quite low VTE rate in shoulder surgery; moreover, few
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informations are available about the need for thromboprophylaxis (if any) in this clinical setting (4-9). To the best of Authors’ knowledge, the incidence and risk factors for VTE in
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shoulder surgery haven’t been investigated with prospective epidemiological studies. The
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primary objective of the present prospective cohort registry is to report on the occurrence of symptomatic VTE following different type of shoulder surgery. Risk factors for VTE and
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thromboprophylactic practices in this surgical population have been also analyzed.
3
ACCEPTED MANUSCRIPT MATERIALS AND METHODS The objective of the RECOS registry was to obtain clinical information on VTE in a large
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cohort of unselected patients undergoing shoulder surgery in Italy.
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Patients
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The RECOS registry included consecutive patients, aged 18 years or older, undergoing different type of open and arthroscopic shoulder surgery: cuff repair, shoulder instability, shoulder replacement, hemiarthroplasty, total anatomical arthroplasty, total
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reverse arthroplasty, shoulder fractures. Nine Italian centers participated in the registry. Exclusion criteria were pregnancy, lactating, declared inability to partake to the scheduled follow up visits, consent denial. No subject could be included twice. The Ethical
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Committee of the participating centres ratified the study protocol. A written informed
Data collection
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consent was obtained in all cases.
Clinical data at the time of surgery and at planned follow-up visits were entered in
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an electronic network. Patient information was obtained by the study coordinator using the electronic case report form and submitted to a data management centre through a secured website. A progressive number has been assigned to each patient in every study centre to permit identification of the subject while protecting personal identity, that was treated as a confidential information. All electronic data with confidential information were secured by passwords and all paper charts were securely stored in convenient spaces at the participating hospitals. Quality of data was applied during the data entry by electronic control. Queries were sent to the local investigator in case of inconsistency.
4
ACCEPTED MANUSCRIPT Collected patient information At the time of surgery demographic characteristics, type and duration of surgery,
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type of anaesthesia, patient position, laboratory test (haemoglobin, platelet count, creatinine, transaminases), concomitant medications, prophylaxis for VTE were recorded.
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Known risk factors for VTE like ongoing neoplastic disease, known thrombophilia, previous
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VTE, venous insufficiency, severe medical diseases were registered. Recent surgery or trauma, immobilization, oral contraceptives, hormonal replacement therapy were also collected as temporary risk factors for VTE. To reflect routine medical practice, the
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decision to initiate thromboprophylaxis (as well as type, dose and duration) was left to the investigators; no specific recommendations were given. After inclusion in the RECOS registry, all patients were evaluated in the out-patient In addition, telephone contacts were scheduled at 90 days.
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clinic after 7 and 30 days.
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Any sign or symptom of VTE were reported. In case of clinical suspicion of DVT or PE, an objective imaging testing was required to confirm the diagnosis (for DVT: compressive ultrasonography, Echocolordoppler, computed tomography scan, venography; for PE:
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perfusion lung scan matched with chest X-ray, ventilation/perfusion scan, computed tomography, angiography. A clinical-events committee whose members were unaware of any information regarding the patients (i.e.
risk factors for VTE,
use of
thromboprophylaxis) adjudicated all components of the clinical end-points (DVT, PE). In case of patient death, date and cause were registered. Information about antithrombotic prophylaxis was also recorded. The study protocol did not dictate any interference with patient management. The choice of diagnostic methods and treatment of the VTE event were left to the attending physicians in the participating centers.
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ACCEPTED MANUSCRIPT Data analysis Cumulative rates of DVT or PE events were estimated according to the Kaplan–Meier
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method, in which data from patients who did not displayed any events where censored at the last follow-up visit. We used the life-table method to determine cumulative event
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probabilities. Median time of follow-up at the first and the third visit were also calculated by
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Kaplan-Meier method.
Differences among patient categories were computed by Contingency Tables and Significance assessed by Chi-Square Test. Differences between continuous variables
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were assessed by student t test. The most relevant variables were included in a Cox proportional regression model in order to estimate the hazard ratios and 95% confidence intervals (CI) of DVT or PE events.
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Variables considered for adjustment in Cox regression analysis were age, gender, BMI,
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length of the intervention (< 60 min or > 60 min), use of prophylaxis, type of surgery. Subsequently, to assess the impact of permanent risk factors for VTE in this setting, cancer, medical disease, venous insufficiency and previous VTE were introduced in the
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model. Known thrombophilia was not considered since this information was collected only in a small number of patients.
6
ACCEPTED MANUSCRIPT SOURCE OF FUNDING The Italian RECOS Registry was supported by an unrestricted educational grant from
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Bayer-Schering; the pharmaceutical company had no role in analyzing the data or
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preparing the manuscript.
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ACCEPTED MANUSCRIPT RESULTS Baseline patient and surgery characteristics
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From June 2009 to June 2011 1378 consecutive patients were included in the registry.
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The analysis population consisted of 1366 evaluable patients (54.4% males), 12 patients ( 0.9%) patients being excluded due to a major protocol violation; the reasons for exclusion
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were absence of follow-up visit (11 patients) and refusal of informed consent (1 patient). The mean age of the study population was 55.65 ±15.3 years (range 18-88 years); males were significantly younger than females (mean age 51.25 ±15.9 versus 60.89 ±12.7 years, The shoulder surgical procedures were the following:
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respectively; p< 0.001).
arthroscopy (71.9%), hemiarthroplasty (17.2%) total replacement (8.9%), fixation for
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proximal humeral fracture (2%). The main concomitant risk factors for VTE were medical comorbidities (heart failure, respiratory failure), venous insufficiency and previous VTE.
anesthesia are
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The description of demographic characteristics, risk factors for VTE, type of surgery and reported in Table 1.
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Thromboprophylaxis
During hospitalization, thromboprophylaxis was initiated in 34.1 % of the patients (n=461) (Table 2). Pharmacological thromboprophylaxis was prescribed in the majority of the cases (n= 457; 33.5%); this was a low-molecular-weight heparin in 98.2% (n = 450), unfractionated heparin in 0.5% (n = 2), antiplatelet therapy in 0.3% (n = 1), other anticoagulants in 1% (n = 4) of the patients, respectively. Pharmacological prophylaxis was started pre-operatively in 75 patients (18.6%), peri-operatively in 42 patients (10.4%), post-operatively in 286 patients (71%), respectively;
in the remaining 54 patients no
informations about initiation of thromboprophylaxis were available. The dose of the lowmolecular-weight heparin used was prophylactic (< 5700 UI/once daily) in 448 out of 450 8
ACCEPTED MANUSCRIPT patients (99.5%). Mechanical prophylaxis was used in
4 patients only (alone in two
patients, in combination with anticoagulation in two patients). Prophylaxis was prescribed
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significantly less frequently in patients undergoing arthroscopy (n=209; 21.3%) than in patients undergoing other surgical procedures (n=251; 65.3%) (p 10 days. The adherence during follow-up to the prescribed prophylaxis was 92.7% after 7 days and 76.3% after 30 days, respectively. The rate of VTE in patients undergoing and not undergoing thromboprophylaxis was
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0.86% (4/461) and 0.55% (5/905), respectively. No significative association was found about the risk of VTE and the use of thromboprophylaxis (Table 3).
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Venous thromboembolism
After 90 days of follow-up 9 patients suffered of symptomatic VTE, resulting a cumulative
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incidence rate of 0.66 % (95CI% 0.2-1.12) (Figure 1). Six patients suffered from lower limb DVT (in five patients proximal, in one patient distal) and two from upper limb DVT. (Table 3). One patient had symptomatic, not fatal PE. to event was 46 days (range 21-90 days).
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surgery
The median time (range) from The diagnosis was confirmed by
imaging techniques in all the cases of DVT (compressive ultrasonography in three cases, Echocolordoppler in five cases), and by clinical suspicion of PE.
computed lung tomography in the patient with
In other 8 patients the clinical suspicion of VTE
was not
confirmed by the clinical-event central committee: in the seven patients with suspected lower limb DVT final diagnosis was superficial phlebitis (five patients) and erysipela (two patients), while in the only one with suspected PE final diagnosis was pneumonia.
No
patients died at the end of follow-up. When the study sample was categorized into a priori risk groups as perceived by the clinicians basing on the type of surgery , the incidence of VTE
was six-fold higher
in patients undergoing total replacement (1.7%) or
hemiarthroplasty (1.7%) than in patients undergoing arthroscopy (0.3%) (Table 4). Mean 9
ACCEPTED MANUSCRIPT age was significantly higher in patient with than in patients without VTE (67.1+/3.49 years vs 55.6+/-0.42 years, respectively; p= 0.024). Co-variates included in the multivariate
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logistic regression analysis and relative HR are shown in Table 4; duration of surgery > 60 minutes (HR:10.99; 95CI% 1.26-95.89; p=0.030) was found as the only independent risk
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factor for VTE. When the presence of known permanent risk factors for VTE (cancer,
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medical disease, venous insufficiency and previous VTE) was introduced in the model, none of these factors resulted significantly associated with an increased risk of VTE and the magnitude of association with duration of surgery > 60 minutes was not significantly
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affected (HR 13.14; 95%CI 1.55-111.72). Thromboprophylaxis was prescribed only in four out of the nine patients who experienced VTE complications (in all cases LMHWs at prophylactic dose); of interest, in all of them VTE occurred after discontinuation of heparin
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administration.
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ACCEPTED MANUSCRIPT DISCUSSION This is the first observational, prospective, multicenter registry study that investigates the
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risk of DVT and PE in patients undergoing shoulder surgery. In the present population the incidence rate of symptomatic VTE confirmed with imaging techniques was about 0.7% at
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3 months. This figure is comparable to those previously reported in large retrospective
rigorous clinical studies
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observational studies (5-7). As far as we know, no large prospective, methodologically have evaluated the real incidence and risk factors of VTE
complications in shoulder surgery and the figures reported in the literature are quite
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different. For example in a small study, Willis et al (10) prospectively followed up at their institute 100 shoulder arthroplasty patients undergoing mandatory upper and lower limb vein ultrasonographic evaluation and found a Doppler-proven DVT rate of 13% after the
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procedure; three patients (3%) had symptomatic PE (in one patient fatal). Moreover,
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Lyman (5) analyzed the New York State Hospital admissions database over a 18-year period, showing after 13759 shoulder arthroplasties a symptomatic PE rate of 0.23% and a DVT rate of 0.5%, respectively. Increasing age, cancer and trauma were the most
VTE
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important risk factors. However, this study has several limitations: the real incidence of is certainly higher, since the available data only reflect
patients in whom the
diagnosis of DVT or PE was performed before discharge from hospital; no informations about the location of the thrombus (upper or lower limb) or the use of thromboprophylaxis are available; the methods for confirming DVT or PE is unknown. large retrospective studies using administrative database
On the contrary, two
have recently reported a low
incidence of VTE in patients undergoing shoulder surgery (6,7). Sperling (6) enrolled in a single-center study in USA 2885 consecutive patients who underwent primary shoulder arhtroplasty between June 1981 and June 2001; during this time period, five patients suffered from acute symptomatic PE (0.17%). Of interest, the length of follow-up after surgery was very short (one week only) and no informations were given about use of VTE 11
ACCEPTED MANUSCRIPT prophylaxis.
Jameson analyzed data of the UK national database for a 42-month period
for planned shoulder surgery (7). Within 90 days after surgery, VTE rate was as follows:
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for total shoulder replacement (4061 patients) 0.2%, for arthroscopic procedures (65302 patients) 0.01%, for hemiarthroplasty (6168 patients) 0.13%, for proximal humeral fracture
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surgery (4696 patients) 0.39%, respectively. The incidence of VTE is certainly under-
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estimated in this study, since only VTE events occurring during surgical admission or requiring hospitalization within 90 days after surgery have been recorded; no data are available about out-patients diagnoses of DVT or PE. Finally, Randelli et al published the
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results of an Italian multicentric study assessing the number of DVT after shoulder arthroscopy occurring in the years 2005 and 2006 (9). During this period, six patients had DVT over a total of 9285 different arthroscopic procedures (0.08%). Moreover, several
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reports of DVT (both upper and lower limb) as well as of PE (fatal and not fatal) have
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been published in patients undergoing shoulder surgery (11-19).
In our study, main permanent risk factors as cancer, previous VTE, venous insufficiency and medical diseases were not associated with an increased risk of VTE; this conclusion
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should be interpretated with caution , since the low rate of thrombosis reported in our study and the small number of patients with such major risk factors. On the contrary, as reported in previous studies (5,7), our data show that open surgery (including total replacement and hemiarthroplasty) and age are factors associated with a higher risk for development of VTE complications; to our knowledge, in our registry for the first time the long duration of intervention (> 60 minutes) was
identified as an independent risk factors for VTE in
shoulder surgery. The fact that these risk factors are similar to those identified for other surgical and medical patients supports the relevance of risk-based thromboprophylaxis guidelines developed on a personal basis.
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ACCEPTED MANUSCRIPT About one-third of subjects were prescribed a thromboprophylactic treatment, mainly with LMWHs (98%) at prophylactic dose and started post-operatively in about 70 % of the
days. Prophylaxis was prescribed
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cases; in most of the patients (95%) the recommended duration of prophylaxis was > 10 less frequently in patients undergoing arthroscopy
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(about 20%) than in patients undergoing other surgical procedures (about 65%); in our
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series, type of surgery (open versus arthroscopic procedures) was the main driver for prescription of thrombopropylaxis. Finally, no significative association was found about the risk of VTE and the use of thromboprophylaxis. These figures are very interesting, since
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to our knowledge detailed informations about daily clinical practice of VTE prophylaxis in shoulder surgery (including type, dose, duration and timing) have never been published before.
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Even if the design of our study (observational registry), as well as the low number of
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symptomatic VTE events do not allow clear cut conclusions about the potential role of prophylaxis in reducing the risk of VTE in this clinical setting, it seems reasonable to suggest a careful stratification of the patients based both on the personal risk factors and
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on the type of surgery. Our data clearly show that open surgery (including total replacement and hemiarthroplasty), long duration of intervention (> 60 minutes) and age are factors associated with a higher risk for developement of VTE complications; thus, in these conditions perioperative antithrombotic prophylaxis may be beneficial.
On the
other hand, our study confirms that shoulder arthroscopy carries a very low risk of VTE, similar to the known population background risk; thus, in this subgroup of patients thomboprophylaxis may not be required. Our study has several limitations. First, the observed rate of VTE may represent a lower estimate of the actual rate, as about a third of subjects received pharmacological thromboprophylaxis, mainly LMWHs which have been demonstrated to significantly reduce the risk of
VTE in different surgical and medical patients (3,10,11); moreover, 13
we
ACCEPTED MANUSCRIPT included only symptomatic and not asymptomatic ultrasound detected DVT
to closely
reflect routine practice. Second, approximately 50% of the suspected symptomatic events
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were not confirmed by the central event committee; however, an objective imaging test was required by the protocol of the study for confirmation of DVT or PE. Third, it is
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possible that the prescribing practices of thrombophylaxis of orthopaedic surgeons may
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have been modified by their participation in the study, even if decision to initiate thromboprophylaxis (as well as type, dose and duration) was left to the investigators and no specific recommendations were given by the protocol of the study.
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However, the strength of this study was the high number of included patients with 3months follow-up. Contemporary studies
about
VTE in shoulder surgery
are
retrospective and have used administrative databases for research (5,7) or have been
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performed in a single center (6). RECOS is a clinical, prospective, multicenter registry risk factors and use
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specifically designed to assess to incidence of symptomatic VTE, of thromboprophylaxis
in an unselected population of consecutive patients undergoing
different type of shoulder surgery. Given its structure and design, RECOS is likely to
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provide informations that are more generalizable than that achieved from retrospective studies carried out basing on administrative data. In conclusion, our registry shows that the rate of symptomatic VTE in patients undergoing shoulder surgery is quite low. Thus, thromboprophylaxis is not mandatory and its use should be based on a case by case evaluation by orthopaedic surgeons.
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ACCEPTED MANUSCRIPT REFERENCES 1. Ageno W, Squizzato A, Garcia D, Imberti D. Epidemiology and risk factors of
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venous thromboembolism. Semin Thromb Hemost 2006; 32:651-8 2. Imberti D, Bianchi C, Zambon A, et al. Venous thromboembolism after major
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orthopaedic surgery: a population-based cohort study. Intern Emerg Med 2012;7
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(3):243-9.
3. Falck-Ytter Y,; Francis CW, Johanson N, et al. Prevention of VTE in Orthopedic Surgery Patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed:
Chest 2012; e278S-e325S.
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American College of Chest Physicians Evidence-Based Clinical Practice Guidelines
4. Blom JW, Doggen CJ, Osanto S, Rosenthal FR. Old and new risk factors for upper
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limb deep vein thrombosis. J Thromb Haemost 2005;3:2471-8.
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5. Lyman S, Sherman S, Carter TI, et al. Prevalence and risk factors for symptomatic thromboembolic events after shoulder arthroplasty. Clin Orthop Relat Res 2006;448:152-6.
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6. Sperling JW, Cofield RH. Pulmonary embolism following shoulder arthroplasty. J Bone Joint Surg Am 2002;84-A(11):1939-41. 7. Jameson S, James P, Howcroft D, et al. Venous thrombolic events are rare after shoulder surgery: analysis of a national database. J Shoulder Elbow Surg 2011;20:764-770. 8. Garofalo R, Notarnicola A, Moretti L, et al. Deep vein thromboembolism after arthroscopy of the shoulder: two case reports and a review of the literature. BMC Musculoskeletal Disorders 2010;11:65-73. 9. Randelli P, Castagna A, Cabitza F, et al. Infectious and thromboembolic complications of arthroscopic shoulder surgery. J Shoulder Elbow 2009;3:123-126.
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ACCEPTED MANUSCRIPT 10. Willis AA, Fealy S, Warren RF, et al.
Deep vein thrombosis following
reconstructive shoulder arthroplasty: a prospective observational study. J Shoulder
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Elbow Surg 2007; 16:e46. 11. Saleem A, Markel DC. Fatal pulmonary embolus after shoulder arthroplasty. J
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Arthroplasty. 2001;16:400-3.
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12. Walper JJ, Markel DC. Upper extremity deep venous thrombosis leading to pulmonary embolism after total hip arthroplasty. J Arthroplasty 2001;16:124-7. 13. Burkhart SS. Deep venous thrombosis after shoulder arthroscopy. Arthroscopy
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1990;6:61-3.
14. Willis AA, Verma NN, Thornton SJ, et al. Upper-extremity deep-vein thrombosis after anterior shoulder dislocation and closed reduction. A case report. J Bone Joint
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Surg Am 2005 ;87:2086-90.
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15. Polzhofer GK, Petersen W, Hassenpflug J. Thromboembolic complication after arthroscopic shoulder surgery. Arthroscopy 2003;19:E16-9. Review. 16. Weber SC, Abrams JS, Nottage WM. Complications associated with arthroscopic
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shoulder surgery. Arthroscopy 2002;18(2 Suppl 1):88-95. 17. Creighton RA, Cole BJ. Upper extremity deep venous thrombosis after shoulder arthroscopy: A case report. J Shoulder Elbow Surg 2007;16:e20-22. 18. Amarasekera SS, van Dalen J, Thompson TJ, Osman M. Pulmonary embolism after an acromioplasty an rotator cuff repair. J Shoulder Elbow Surg 2008. In print. 19. Cortés ZE, Hammerman SM, Gartsman GM. Pulmonary embolism after shoulder arthroscopy: Could patient positioning and traction make a difference? J Shoulder Elbow Surg 2007; 16:e16-17.
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ACCEPTED MANUSCRIPT LEGEND FIGURE 1: Cumulative incidence of VTE in the study population
TABLE 2: Rate of thromboprophylaxis in the study population
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TABLE 3: Multivariate analysis of risk factors of VTE event
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TABLE 1: Demographic and clinical features of the analysed population (n = 1366)
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TABLE 4: Comparison of different type of shoulder surgery for risk of VTE
17
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Figure 1
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ACCEPTED MANUSCRIPT
18
Age (years), median (range)
55.65 ±15.3 (18-88)
Male gender n (%)
743 (54.4)
BMI
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≥ 30 n (%)
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160 (11.7)
1206 (88.3)
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< 30 n (%)
Permanent known risk factors for VTE
Medical disease n (%)
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Venous insufficiency n (%)
Known thrombophilia n (%)
Previous VTE n (%)
66 (4.8)
8 (0.6)
10 (0.8)
16 (1.2)
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Temporary known risk factors for VTE
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Cancer n (%)
153 (11.2)
Recent (< 3 months) surgery or trauma
26 (1.9)
Immobility (< 7 days)
9 (0.7)
17 (1.7)
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Oral contraceptives
Hormonal replacement therapy
8 (0.8)
Surgery
Type
Arthroscopy n (%)
982 (71.9)
Hemiarthroplasty n (%)
235 (17.2)
Total replacement n (%)
121 (8.9)
Fixation for proximal humeral fracture n (%)
28 (2)
Duration
≤ 60 minutes n (%)
931 (68.2)
19
ACCEPTED MANUSCRIPT > 60 minutes n (%)
435 (31.8)
Position of the patient
173 (12.7)
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Supine decubitus
896 (65.6)
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Beach chair decubitus n (%)
53 (3.9)
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Lateral decubitus n (%)
Lateral decubitus with traction n (%)
Anesthesia
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Local n (%) Loco-regional n (%) General n (%)
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Table 1
1 (0.1) 202 (15.2) 260 (19) 902 (65.9)
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Combined n (%)
243 (17.8)
20
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33.5
Mechanical
2
0.3
Both
2
0.3
None
905
65.9
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Pharmacological
%
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Table 2
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Number of patients (n = 1366) 457
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Type of thromboprophylaxis
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95%CI*
P value
Male
1.7
0.3 – 9.6
0.504
Age
1.0
0.9 - 1.1
0.081
BMI > 30
0.9
0.7-1.1
Duration of surgery > 60 minutes
10.99
1.26-95.89
Use of thromboprophylaxis
0.493
0.1-2.2
2.3
0.2-23.3
0.314 0.030
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Other surgery **
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Hazard Ratio
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Risk factor
* confidence intervals ** arthroscopy as reference group
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Table 3
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0.359 0.469
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N = 982
N = 235 Rate n %
N = 121 Rate n %
1 0 1
0.85
1
n
3 1 2
1.27
Upper limb DVT
0
0
1
0.43
Pulmonary embolism
1
0.1
0
0
Any VTE events
3
0.3
4
Death
0
0
0
All shoulder surgery
N = 1366 Rate n %
0
6
0.45
0.85
0
0
2
0.14
0
0
0
0
1
0.07
1.7
2
1.7
0
0
9
0.66
0
0
0
0
0
0
0
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Table 4
Fixation for proximal humeral fracture N = 28 Rate n %
0
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2 0 2
0.2
Distal DVT Proximal DVT
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Lower limb DVT
Rate %
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Outcome
Total replacement
PT
Hemiarthroplasty
RI
Arthroscopy
23
