Eur Radiol (2013) 23:2042–2048 DOI 10.1007/s00330-013-2778-1

VASCULAR-INTERVENTIONAL

Peripherally inserted central catheter placement in cancer patients with profound thrombocytopaenia: a prospective analysis Julien Potet & Alphonse Thome & Emmanuel Curis & François-Xavier Arnaud & Gabrielle Weber-Donat & Laura Valbousquet & Evelyne Peroux & Eric Flor & Christophe Dody & Johanna Konopacki & Jean Valère Malfuson & Cecile Cartry & Marion Lahutte & Thierry de Revel & Jacques Baccialone & Christophe A. Teriitehau

Received: 30 August 2012 / Revised: 16 December 2012 / Accepted: 19 December 2012 / Published online: 26 February 2013 # European Society of Radiology 2013

Abstract Objective No studies have specifically evaluated the safety of peripherally inserted central catheter (PICC) placement in patients with profound thrombocytopaenia. We prospectively determined the frequency of haemorrhagic complications of PICC placement in cancer patients with uncorrected profound thrombocytopaenia. Methods Profound thrombocytopaenia was defined as a platelet count <50×109/l. No patients received transfusions before or after the procedure. Three types of adverse effects Julien Potet and Alphonse Thome contributed equally to this work J. Potet (*) : A. Thome : F.-X. Arnaud : G. Weber-Donat : L. Valbousquet : E. Peroux : E. Flor : C. Dody : J. Baccialone : C. A. Teriitehau Radiology Department, Percy Military Hospital, Avenue Henri Barbusse, 92140 Clamart, France e-mail: [email protected] E. Curis Pharmacy Faculty, Biomathematics Laboratory, Paris Descartes University, 4, Avenue de l’Observatoire, 75270 Paris Cedex, France J. Konopacki : J. V. Malfuson : T. de Revel Haematology Department, Percy Military Hospital, Avenue Henri Barbusse, 92140 Clamart, France C. Cartry Radiology Department, Begin Military Hospital, 69, Avenue de Paris, 94160 Saint-Mande, France M. Lahutte Radiology Department, Val de Grace Military Hospital, Boulevard Port Royal, 75005 Paris, France

were analysed: minor oozing, mild haematoma and major haemorrhage. Results One hundred and forty-three PICC implantations in 101 cancer patients were prospectively included in the study: seven patients (7 %) had a solid tumour and 94 (93 %) a haematological malignancy. Among these 143 procedures in thrombocytopaenic patients, 93 (65 %) were performed with a platelet count 20–50×109/l and 50 (35 %) had lower than 20× 109/l. No major haemorrhage was observed. Minor oozing was observed in six implantations (4 %) and mild haematoma in two (1.5 %), for a total of eight minor haemorrhagic adverse events (5.5 %). In patients with a platelet count <20×109/l, 1/50 (2 %) had minor oozing and none had minor haematoma. Conclusions In cancer patients with uncorrected profound thrombocytopaenia, the incidence of adverse events after PICC implantation was low, and was limited to minor haemorrhagic adverse events. Key Points • PICC placement has high technical success in profound thrombocytopaenic cancer patients. • Few adverse events are encountered after PICC placement, limited to minor haemorrhage. • PICC placement does not routinely require platelet transfusion in patients with thrombocytopaenia. • Such PICC placement still seems safe when the platelet count is <20×109/l. Keywords PICC line . Ultrasound . Haemostasis . Thrombocytopaenia . Cancer Abbreviations APTT Activated partial thromboplastin time CVC Centrally inserted venous catheters INR International normalised ratio

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PICC PT SIR

Peripherally inserted central catheter Prothrombin time Society of Interventional Radiology

Introduction The need for central venous access in the management of patients with cancer has increased in current medical practice [1]. Therefore, peripherally inserted central venous catheters (PICC) are widely used for central venous access in medium- to long-term intravenous drug therapy, such as antibiotics and chemotherapeutic agents, total parenteral nutrition, and in patients with poor peripheral venous access [1–8]. Despite a high overall incidence of peripheral phlebitis [9–11], PICC has indeed been demonstrated to be an outstanding tool for providing long-term intravascular access in oncology patients, offering an attractive alternative to other available indwelling central venous catheters (CVCs) and devices. One particular interest of PICCs is the low risk of procedure-related trauma, with a mild risk of significant bleeding and a local haemostasis easily achievable [12, 13]. The Society of Interventional Radiology (SIR) Standards of Practice Committee has recently published consensus guidelines for the haematological management of patients undergoing percutaneous image-guided intervention [14]. In the present article, PICC placement was considered to be a procedure with a low risk of bleeding, which was easily detected and controllable. However, authors of the SIR Standards of Practice Committee recommended the transfusion of platelets for any platelet count of less than 50×109/l. Platelet transfusions have known risks and costs, are often not available [15–18] and the transfusion process places further economic demands on the hospital and treatment team [19]. There are several reports on the safety of CVC placement in patients with profound thrombocytopaenia [20–23], but to our knowledge, no study has specifically evaluated the safety of PICC placement in a consecutive number of thrombocytopaenic cancer patients. The purpose of this study was to prospectively determine the frequency of haemorrhagic complications of PICC placement in cancer patients described as having a platelet count ≤50×109/l.

Materials and methods Informed consent was obtained from each patient before the procedure. This prospective study was approved by our Institutional Review Board. Patient population We prospectively included cancer patients with profound thrombocytopaenia who underwent PICC placement in

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our Interventional Radiology Department. Profound thrombocytopaenia was defined as a platelet count ≤50× 109/l. None of the patients received transfusions before the procedure. Patients were included from December 2008 to August 2012. For all patients, we assessed the platelet count, the activated partial thromboplastin time (APTT) and the prothrombin time (PT). These tests were performed within 4 h before the procedure. Haemorrhagic complications were systematically reported by interventional radiologists immediately after the procedure and by department nurses and physicians during the patient’s hospitalisation. All patients were examined for evidence of bleeding, and the nurses were instructed to report any evidence of bleeding or haematoma formation. All untoward events were recorded. The search of bleeding complications was performed throughout the duration of hospitalisation or until the removal of the PICC. Definition of haemorrhagic complications 1. Minor haemorrhagic adverse events. Minor oozing at the exit site and mild haematoma not requiring ablation or haemostasis surgery were considered as minor haemorrhagic adverse events. Minor oozing at the exit site: requiring the change of bandage more than twice/day AND improving within 24 h AND not requiring haemostasis surgery. Mild haematoma: non-expanding and mild subcutaneous haematoma <5 cm in diameter AND not requiring haemostasis surgery. 2. Major haemorrhage Subcutaneous bleeding >5 cm OR minor haemorrhage not improving within 24 h OR bleeding requiring ablation or haemostasis surgery.

Technique All insertions were performed by four interventional radiologists. Five-French single lumen Bard PowerPICC (Bard Access Systems, Salt Lake City, UT, USA) catheters were used in our patients. Peripheral venous access was obtained through the basilic or the brachial vein with ultrasound guidance. One to 5 ml of local anaesthetic (lidocaine 1 %) was injected immediately adjacent to the anterior vein wall and into the subcutaneous tissue. A 20-gauge needle was inserted systematically with ultrasound guidance until the anterior vein wall was reached and crossed. The needle was introduced into the vessel until a blood return was observed. A metallic 0.018-inch guide wire was then introduced into the vein using fluoroscopic guidance. The puncture site was then enlarged slightly with a scalpel blade and the 5-Fr micro-introducer assembly was introduced over the guide

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wire. The catheter was inserted into the micro-introducer sheath and using fluoroscopy, the position of the catheter tip was immediately checked. None of the PICCs were sutured; they were held in place with StatLock adhesive dressings (StatLock; Bard, Murray Hill, NJ, USA). Concerning the vein puncture, the position of the punctured vein was systematically recorded. A cannulated vein was considered closed to the brachial artery if it was located less than 1 cm to the artery. Finally, we noted if the artery was anterior to the vein punctured. Statistical analysis All analyses were conducted using the R software version 2.14.0 (R development Core Team, R foundation for Statistical Computing, Vienna, Austria). Ninety-five percent confidence intervals of haemorrhagic adverse events frequency were calculated using the exact binomial law. The variables—including the type of operator (resident or fellow), type of vein (basilica or brachial), number of punctures, platelet count, PT and APTT values, aetiology (acute myeloblastic leukaemia, acute lymphoblastic leukaemia, Hodgkin lymphoma, multiple myeloma, lung cancer or HCC) and the vein position—were analysed as potential predisposing factors for haemorrhagic complications. The relationship between haemorrhagic complications and these variables for each patient was tested using Fisher’s exact test (for contingency tables) or logistic regression and P<0.05 was considered to indicate statistical significance.

Results A total of 143 catheters were inserted in 101 consecutive patients, 61 male (60 %) and 40 female (40 %). Patient’s ages ranged from 16 to 86 (mean: 45.4±12.2) years. The range, mean and median of days that the patients were followed-up for bleeding complications monitoring were 15–122, 32 and 36.9 days respectively. The range, mean and median of hospitalisation were 20–158, 43 and 47.8 days respectively. None of the patients received drugs that may have affected haemostatic status (aspirin, clopidogrel, heparin or warfarin). No patient received platelet transfusion within 24 h after the procedure. However, 56/101 (55 %) of the patients received platelet transfusion after 24 h post PICC placement during hospitalisation. PICC placement was achieved in all patients. Catheter placements were successful at the first puncture in 122 procedures (85 %), second puncture in 15 procedures (10 %) and third puncture in six procedures (5 %), with a mean number of attempts of 1.18. No accidental puncture of the brachial artery occurred. All patients had a history of malignancy.

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Seven (7 %) had a solid tumour and 94 (93 %) a haematological malignancy (Table 1). Peripheral venous access was obtained through the basilic and the brachial vein respectively in 90 (63 %) and 53 (37 %) underwent PICC placement. Seventy-one patients had a single PICC placement (n=71, 71 %), 22 patients underwent two (22 %), five underwent three (5 %), two underwent four (2 %) and one underwent five (1 %). Ten (7 %) of the PICC lines were placed for antibiotic therapy, 96 (67 %) for chemotherapy, 37 (26 %) for chemotherapy/antibiotic therapy. Prolonged PT and APTT were observed in three PICC placements (2 %), but were lower than 1.5-times the normal and no fresh frozen plasma transfusions were administered before venous puncture. Haemorrhagic complications according to platelet count and patient characteristics are shown in Tables 2 and 3 respectively. No major haemorrhage was observed (0 %, frequency <2.5 %, 95 % CI). One of eight (12 %) and 7/135 (5 %) minor haemorrhagic adverse events occurred in procedures performed in patients with solid tumour and haematological malignancy respectively. Five of 90 (5.5 %) and 3/53 (5.6 %) minor haemorrhagic adverse events occurred in procedures when the basilic and the brachial vein were cannulated respectively. Three of 57 (5.2 %) and 5/86 (5.8 %) minor haemorrhagic adverse events occurred in procedures performed when the punctured vein was close and far from the brachial artery respectively. Finally, no minor haemorrhagic adverse events occurred in the four procedures where the vein was located posteriorly to the brachial artery. Minor oozing was observed in six implantations (4.2 %) (frequency <9 %, 95 % CI). The variables of type of operator, type of vein, number of punctures, PT and APTT values, and aetiology were not associated with minor oozing (P>0.05). Mild haematoma was observed in two implantations (1.4 %) (frequency <9 %, 95 % CI), for a total of eight minor haemorrhagic adverse events (5.5 %; frequency <0.11 %, 95 % CI). The variables, type of operator, type of vein, number of punctures, PT and APTT

Table 1 Patient characteristics Solid tumour HCC Lung Haematological malignancy Acute myeloid leukaemia Acute lymphocytic leukaemia Hodgkin lymphoma Multiple myeloma Others Total HCC hepatocellular carcinoma

7 (7 %) 1 (1 %) 6 (6 %) 94 (93 %) 70 (69.5 %) 15 (14.8 %) 2 (1.9 %) 3 (2.9 %) 4 (3.9 %) 101

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Table 2 Haemorrhagic complications according to platelet counts Platelet count

Platelet count mean ± SD

Minor oozing

Minor haematoma

Major haemorrhage

Total

0
25.5×109 ±12 [4–49×109] 14.9×109 ±5.8 [4–20×109] 38.3×109 ±7.9 [21–49×109]

6/143 (4 %) 1/50 (2 %) 5/93 (5 %)

2/143(1.5 %) 0/50 (0 %) 2/93 (2 %)

0/143(0 %) 0/50 (0 %) 0/93 (0 %)

8/143(5.5 %) 1/50 (2 %) 7/93 (8 %)

SD standard deviation, PC platelet count

values, and aetiology, were not associated with mild haematoma (P>0.05). Among all patients with a profound thrombocytopaenia, 50 presented a platelet count lower than 20 × 10 9 /l, 1/50 (2 %) minor oozing and no minor haematoma was observed (Tables 2 and 3). Oozing was minimal and was relieved with local pressure, and minor haematomas resolved within 24 h, neither necessitating platelet transfusions. The variables platelet count (less than and more than 20× 109) were not associated with mild haematoma or minor oozing (P>0.05).

Discussion We reported that haemostasis-related adverse events after PICC implantation were quite low in cancer patients with profound thrombocytopaenia. Despite the absence of platelet transfusion, only 5.5 % minor haemorrhagic adverse events were observed (minor oozing was observed in 4 %, mild haematoma in 1.5 %). Among these patients, 50 had uncorrected thrombocytopaenia less than 20×109/l (minor oozing observed in 2 %, mild haematoma in 0 %).

Table 3 Characteristics of patients with minor haemorrhage adverse events Minor haemorrhage adverse events Patients 8/143 (5.5 %) Number of punctures -1 6/122 (4.9 %) - More than 1 2/21 (9 %) Vein puncture - Basilic 5/90 (5.5 %) - Brachial 3/53 (5.6 %) Platelet count - 0
Variables tested using Fisher’s exact test

b

Variables tested using logistic regression

P

Minor oozing

P

Mild haematoma

6/143 (4.1 %)

P

2/143 (1.4 %)

0.73b

5/122 (4 %) 1/21 (4.5 %)

0.91b

1/122 (0.9 %) 1/21 (4.5 %)

0.45b

1a

4/90 (4.4 %) 2/53 (3.7 %)

1a

1/90 (1.1 %) 1/53 (1.9 %)

1a

0.16a

1/50(2 %) 5/93 (5.3 %)

0.31a

0/50 (0 %) 2/93 (2.7 %)

0.42a

0/8 (0 %) 2/135 (1.5 %)

0.89a

0/22 (0 %) 2/121 (1.6 %)

0.28a

1/89 (1.1 %) 1/21 (4.7 %) 0/7 (0 %) 0/26 (0 %)

0.61a

1/57 (1.7 %) 1/86 (1.2 %)

1a

0/4 (0 %) 2/139 (1.4 %)

1a

0.38a 1a

1/22 (4.5 %) 5/121 (4.1 %)

a

0.6

a

1

1a

1/8(12 %) 5/135 (3.5 %)

3/89 (3.3 %) 1/21 (4.7 %) 1/7 (14 %) 1/26 (3.8 %) 2/57 (3.5 %) 4/86 (4.6 %) 0/4 (0 %) 6/139 (4.3 %)

0.3a 0.59a

0.49

1

a

1a

a

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Placement of PICC was achieved in all patients under ultrasound guidance and the mean number of attempts was 1.18. Venous ultrasound guidance is classically used to perform the venous puncture. Complications that occurred during or immediately after the procedures were all minor haemorrhagic adverse events, which were easily controlled with compression and did not increase the morbidity or the hospital stay. Ultrasound guidance has several advantages with regard to PICC and CVC placement. It increases the number of successful first passes, the overall technical success rate and allows low complication rates [24–29]. Sofocleous et al. [28] reported the absence of haemorrhagic complications after PICC placement under venous ultrasound guidance in a review of 355 procedures. However, the aetiology and the platelet count were not specified in this study. Harter et al. [8] described no haemorrhagic complications after PICC placement for autologous blood progenitor cell transplantation in patients with haematological malignancies. In these patients, a landmark method was used to catheterise the chosen vein. Nevertheless, no mention was given concerning the platelet count. Moreover, the authors did not specify if haemorrhagic complications were monitored in the study. In the study by Oguzkurt et al. [29], 61 temporary internal jugular vein catheters were placed under ultrasound guidance in patients who had a bleeding tendency or who were on anticoagulation for different reasons. A tendency to bleed was regarded as a platelet count <50 × 10 9 /l (range 7,000–42,000), an APTT level >50 (range, 52–120 s), or an INR level >1.5 (range, 1.7–5.6), alone or in combination. The underlying disorder of haemostasis was not corrected before catheter placement in any patients. Three pericatheter oozings (5 %) were described in these patients. But the number of patients with abnormalities of primary haemostasis and secondary respectively was not specified. Ultrasound guidance helps to avoid inadvertent brachial arterial puncture (absent in our study) and major haemorrhagic complications by locating normal venous variations and showing the relationship of the vein to the adjacent anatomical structures [30]. We know that the brachial vein may be located near or immediately under the brachial artery. We may sometimes be forced to use a more complicated tract of the needle between the brachial artery and the biceps muscle to catheterise the brachial vein if the latter is deeply located (Fig. 1). Thus, Sofocleous et al. [28] described no inadvertent brachial arterial puncture in 355 PICCs placement, and Oguzkurt et al. [29] reported four (1.8 %) in 220 temporary internal jugular vein catheters. Oguzkurt et al. [29] specified that the carotid artery puncture rate was reported to be between 1.2 and 2.4 % under US guidance and around 8 % with the landmark method, suggesting the superiority of the ultrasound guidance in the prevention of

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inadvertent arterial puncture [29]. Moreover, the incidence of complications increases in cases of CVC placement when multiple attempts are required for cannulation [24, 25, 31–35]. Moreover, the use of ultrasound improves practice and reduces complication rates in peripherally inserted central catheter insertions. In the study by Stokowski et al. [36], the findings from data collected on 538 patients included a significant decline in the thrombosis rates, as thrombosis decreased from 9.3 % with the palpation method to 1.9 % with the ultrasound method, and successful PICC placements increased from 76.9 % when using the old method to 98.9 % when using ultrasound guidance. We believe that ultrasound-guided PICC placement contributed to a low haemorrhagic complication rate in our patient population with profound disorders of haemostasis by contributing to a high rate of success at the first puncture (85 %) and second puncture (10 %), and allowing us to avoid incidental brachial arterial or biceps muscle puncture. Avoiding platelet transfusions presents several advantages. First, a low availability of platelets and blood product can exist in many hospitals. Blood centres and hospital transfusion services are challenged with maintaining an adequate platelet inventory to avoid a major shortage [37]. We must therefore economise and use platelet transfusion in appropriate clinical situations. Second, the process of transfusion may delay patient care by delaying the availability of central venous access. Third, it eliminates the risks associated with platelet transfusion [15–18]. Finally, it reduces the monetary cost of the transfused products [19]. The annual cost savings that might be achieved by avoiding transfusions in patients with platelet count of at least 50×109/l is probably considerable [19]. To our knowledge, this is the first study to specifically evaluate the frequency of haemorrhagic complications after PICC placement in patients with profound thrombocytopaenia. However, other authors have dealt with PICC placement in cases of profound thrombocytopaenia in more general studies, but did not focus specifically on haemostasis disorders and smaller samples of patients. Strahilevitz et al. [38], for example, presented a series of 40 patients with acute leukaemia. Thirty-three PICCs were inserted into these patients who had thrombocytopaenia below 50×109/l. Strahilevitz et al. [38] showed that complications were very low in spite of thrombocytopaenia. However, no details were given concerning the presence or absence of platelet transfusion before the procedure, or the severity of thrombocytopaenia and haematoma. Abi-Nader [39] described PICC placements without haemorrhagic complications in 97 patients, but only three of these were <50×109/l at the time of insertion. None had haemorrhagic complications. In a larger population of cancer patients with profound thrombocytopaenia, particularly in those with a platelet count lower than 20 ×109/l, we

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Fig. 1 Different locations of the brachial vein. a Near the brachial artery. b Under the brachial artery. c Under the brachial artery and the biceps muscle (a brachial artery, bm biceps muscle, m median nerve, n needle, u ulnar nerve, v brachial vein)

confirmed that the incidence of adverse events after PICC implantation was low, and limited to minor haemorrhagic adverse events (only three with minor oozing out of 71 patients with thrombocytopaenia lower than 20×109). On the other hand, several studies have already focused on bleeding complications after CVC placement in patients with thrombocytopaenia. Barrera et al. [34] evaluated haemorrhagic morbidities associated with the insertion of CVCs in severely thrombocytopaenic cancer patients (≤20× 109). Of the total number of 115 catheters inserted, 23 minor haemorrhagic complications (20 %) occurred and one pneumothorax was described. The mean pre-procedure platelet counts were 14.8×109 for the subclavian group and 14.3× 109 for the internal jugular group. However, an initial platelet count ≤20×109 required platelet transfusion in the study by Barrera et al. [34], and 93 % of these patients underwent transfusion with a median of 6 units of platelets. In comparison, in our study, 50 patients undergoing PICC placements had a platelet count ≤20×109 but no platelet transfusion was administered before and after PICC placement. The mean pre-procedure platelet count was 14.9×109 and there was only one patient out of 50 with minor oozing (2 %) in this situation. Paradoxically, the incidence of bleeding was moreover lower in the cohort of patients with a platelet count ≤20×109, and we can hypothesise that the operators may be more cautious during the venous puncture when they knew that the patients had a platelet count ≤20×109. However, the difference between these two groups was not statistically significant (P>0.05, Fisher’s exact test), reducing the relevance of this difference. Finally, no pneumothorax was described after PICC placement in our study. Mumtaz et al. [22] reported that the incidence of bleeding complications after CVC placement in patients with uncorrected abnormal haemostasis was 3 % with the landmark method. Only those complications that required an intervention other than digital pressure was defined as a bleeding complication. Minor complications were not taken

into account in this study. Doerfler et al. [40] reported pericatheter bleeding and a small haematoma in 8 % of their p a t i e n t s . H o w e v e r, t h e s e t w o s t u d i e s d e f i n e d thrombocytopaenia as <100×109 and 150×109/l respectively [22, 40]. Finally, Tercan et al. [21] evaluated the technical success and immediate complication rates of temporary CVC in a homogeneous patient population with haemostasis disorders. Only 38 patients had isolated thrombocytopaenia (defined as <50× 109/l). The exact rate of haemorrhagic complications was not specified for this category of patients but the low platelet count was considered an independent risk factor for persistent oozing and haematoma formation. Two limitations of the study should be mentioned. Firstly, we did not study patients with abnormalities of secondary haemostasis (one patient). Thus, we cannot make recommendations concerning haemostatic management before PICC placement in patients with elevated PT or APTT. Secondly, the number of patients in this cohort was quite low. These results are encouraging but should be confirmed on larger series. In conclusion, PICC placement had very high technical success rates, was very safe with very few minor haemorrhagic complications in profound thrombocytopaenic cancer patients and platelet transfusion was not required before, during or immediately after the procedure. Despite the consensus guidelines proposed by the SIR Standards of Practice Committee [14] recommending correction of platelet counts lower than 50×109/l, we believe that the placement of PICCs in patients with a platelet count between 20 and 50× 109/l and lower than 20×109/l is safe even without platelet transfusions. We believe that platelet transfusion is not required before inserting PICC device in thrombocytopaenic patients (≤50×109/l), provided that the patient has not associated secondary haemostasis abnormalities and do not receive drugs that may have affected haemostatic status.

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