Abstract
Central venous access devices (CVADs), such as tunneled central venous catheters (tCVADs) and peripherally inserted central catheters (PICCs), help provide essential care for some patients with sickle cell disease (SCD). CVADs facilitate administration of multiple intravenous (IV) medications and blood products, as well as blood draws for laboratory analysis. Understanding CVAD use and complications is particularly relevant for SCD patients because of their high risk of having insufficient peripheral IV access. Prior studies describing CVAD use and complications in SCD patients were limited by small sample sizes, typically including 15-20 SCD patients in a single treatment center. The resulting estimates for CVAD use and complications in SCD patients vary widely, are insufficient for development of evidence-based guidelines, and may not be representative of the treatment burden in the broader SCD population. The purpose of this study was to describe the frequency of CVAD use and CVAD-associated complications among SCD patients in a large US population sample.
We used data from two large U.S. insurance claims databases from Truven Health MarketScan® Research to examine both Medicaid-insured and commercially-insured SCD patients. From January 2009 through December 2013, these databases encompassed over 14 million Medicaid-insured and over 116 million commercially-insured patients. SCD patients were defined as patients with at least two International Classification of Disease-9 (ICD-9) diagnosis codes for SCD (282.41-42, 282.6x) on separate dates in excess of sickle cell trait codes, or one ICD-9 code for an inpatient (emergency department or hospitalization) visit with sickle cell crisis. CVAD insertions were identified using relevant procedure codes for tCVADs or PICCs. We conducted two sets of analyses for each database: (1) per patient among those with at least one CVAD insertion, and (2) per CVAD insertion. We conducted descriptive analyses on the frequency of CVAD-related procedures (e.g., repair, replacement, removal of obstructive material, repositioning), complications, and infections, thromboses, or phlebitis.
A total 17,119 Medicaid-insured SCD patients and 21,342 commercially-insured SCD patients were observed for an average of 3-4 years, during which 1,945 (11.4%) and 1,316 (6.2%) patients, respectively, had at least one CVAD insertion. Most SCD patients (80%) were aged >18 y at time of first CVAD insertion; 18% of adult Medicaid SCD patients had at least one CVAD inserted. The mean number of CVAD insertions per patient was 3.1 (Medicaid) and 2.4 (commercially-insured). In the per CVAD analysis, complication claims were frequent, including infection (31-37%), thrombosis (4-5%), and phlebitis/thrombophlebitis (12-15%). The mean time to removal of CVADs (duration) was 31-34 days (PICC lines) and 102 days (tCVADs). In the per patient analysis, 54.3% had infection claims, 24.3% had thrombosis claims, and 10.2% had phlebitis/thrombophlebitis claims in Medicaid (see Table and Figure; additional results to be provided, also stratified by age).
Both tCVADs and PICCs were commonly used in SCD patients, particularly adults, with high occurrence of infection, thrombosis and phlebitis/thrombophlebitis, as well as repeated CVAD insertions. Determinants of CVAD use and complications warrant further investigation to inform practice standards. These findings from a large observational study indicate that device-related risks of administering IV treatments are limitations of IV treatment options and may add to SCD treatment burden.
Table 1. Medicaid-Insured Commercially-Insured Any CVAD (Overall) PICC Only tCVAD Only Both PICC and tCVAD Any CVAD (Overall) PICC Only tCVAD Only Both PICC and tCVAD N (%) 1,945 681 (35.0%) 893 (45.9%) 371 (19.1%) 1,316 450 (34.2%) 664 (50.5%) 202 (15.3%) Age, mean (sd) y 30.0 (16.3) 34.2 (14.9) 26.9 (17.5) 30.1 (13.6) 32.6 (17.1) 34.1 (15.8) 31.3 (18.3) 33.2 (15.9) CVAD insertions per patient, mean (sd) 3.1 (3.9) 3.1 (3.9) 1.8 (1.3) 6.2 (5.8) 2.4 (2.3) 2.5 (2.6) 1.6 (1.0) 4.5 (2.9) CVAD insertions total 6,107 3,651 2,456 n/a 3,082 1,636 1,446 n/a Duration per CVAD, median days 44 31 102 n/a 53 34 102 n/a CVAD complications, % patients with CVAD Complication, general 28.8% 13.2% 31.8% 50.1% 22.3% 9.1% 25.9% 39.6% Removal of obstructive material 11.2% 3.8% 15.3% 14.6% 9.0% 2.4% 11.4% 15.3% Replacement 8.3% 3.7% 10.2% 12.4% 6.5% 3.8% 6.5% 12.9%
Figure 1. Figure 1.
Disclosures
Maserejian: Biogen: Employment, Equity Ownership. Hayflinger:Biogen: Consultancy, Employment. Eaton:Biogen: Employment, Equity Ownership. Madigan:Biogen: Employment, Equity Ownership. Hobbs:Biogen: Employment, Equity Ownership.
Red cell exchange: special focus on sickle cell disease
