Highly Controlled Vascular Syringes for Pericardiocentesis

­ABSTRACT: Objectives. The present study determined the utility and needle control characteristics of highly controlled vascular syringes for image-guided pericardiocentesis. Background. Vascular syringes have been integrated into invasive cardiovascular procedures with improved patient safety, but to date have not been used in pericardiocentesis. To address this issue, we determined the method of use of vascular syringes for pericardiocentesis. Methods. A vascular syringe with reciprocating plungers, the reciprocating procedure device (RPD syringe), replaced the corresponding 10 ml and 20 ml conventional syringes in a standard pericardiocentesis tray. The vascular syringe is controlled with one hand, and can either aspirate or inject by pushing the corresponding aspiration or injection plunger. Four hundred and thirty seven subjects underwent vascular syringe procedures. The linear displacement method was used to precisely measure control of the needle tip in millimeters (mm) in vascular syringes compared to conventional syringes in 20 individual operators. Results. Relative to the corresponding 10 ml and 20 ml conventional syringes, vascular syringes significantly reduced unintended forward penetration of the needle tip by 44% (7.0 ± 4.3 mm; p Conclusion. Vascular syringes improve needle control in pericardiocentesis, promote patient safety and permit one-handed aspiration and injection. J INVASIVE CARDIOL 2010;22:580–584 Key words: pericardiocentesis, safety, complications, needle, syringe ———————————————————— Advances in the diagnosis of pericardial disease have progressed remarkably with the growth of noninvasive diagnostic methods including echocardiography, computed tomography, fluoroscopy and magnetic resonance imaging.^1–7 Although these imaging modalities have improved noninvasive detection of complicated pericardial disease, invasive pericardiocentesis performed with a syringe and needle remains an essential tool in the emergent evaluation, diagnosis and therapy of a large pericardial effusion with or without cardiac tamponade.^1–10 The complications of pericardiocentesis can be serious and include cardiac puncture, laceration of the coronary arteries, puncture of the left internal mammary artery, pneumothorax, pneumopericardium, hemothorax, mediastinitis, abscess, cardiopulmonary arrest or death.^1–15 Many of these complications are directly related to misdirection, inadequate control or mismanipulation of the needle and/or syringe. Vascular syringes have been developed for invasive procedures where precise and safer control of the needle-tip is important.^16–18 Since procedural complications cause considerable patient suffering, cost an additional $7,000–13,000 per complication and increase the overall costs of medical care, patient safety experts recommend the integration of inexpensive safety technologies wherever possible, assuming that the individual procedure in question can still be performed efficiently using that safety technology.^19–32 The present report determined the feasibility of using highly-controlled vascular procedure syringes to improve the performance and safety of pericardiocentesis.

Methods

This project was in compliance with the Declaration of Helsinki and was approved by the institutional review board. This study is registered at www.clinicaltrials.gov (Registration Number NCT00651625). All subjects provided informed consent. Patient confidentiality and privacy were protected according to the Health Insurance Portability and Accountability Act (HIPAA). All products used in these procedures were commercially available, U.S. Food and Drug Administration (FDA)-cleared, CE-marked and used on-label. Vascular syringes for pericardiocentesis. Although individual components can vary, a typical pericardiocentesis kit includes chlorhexidine solution applicators; sterile drape towels; 25 gauge and 21 gauge 1.5 inch conventional needles for local anesthesia; an 18 gauge 9 cm spinal-style needle; dilator; 8 French (Fr) pigtail drainage catheter; a 0.35" x 80 cm guidewire with a J tip; #11 blade; silk suture; an electrocardiogram connector wire with alligator clamps; 2% lidocaine; 5 ml, 10 ml and, 20 ml syringes; 3-way stopcock; extension tubing; sterile ultrasound gel; collection tubes; gauze sponges; and a 1,000 ml drainage bag. In the methodology using a vascular syringe, the conventional syringes are replaced by 5-ml, 10-ml and 20-ml vascular syringes (RPD Syringe, AVANCA Medical Devices, Inc., Albuquerque, New Mexico). Vascular syringes are FDA-cleared and CE-marked, and enhance patient safety by providing more accurate needle control during aspiration or aspiration-injection.^16–22 A 3 or 5 vascular syringe was used for local anesthesia (Figures 1 and 2), and a 10 or 20 ml vascular syringe for pericardiocentesis (Figures 3–5). The vascular syringe is a mechanical syringe that is formed around the core of a conventional syringe barrel and plunger, but has an extra plunger and barrel. The two plungers are mechanically linked by a pulley system in an opposing fashion, resulting in a set of reciprocating plungers. Thus, when one plunger is depressed with the thumb, the syringe injects, and when the opposing plunger is depressed, the syringe aspirates, and the index and middle fingers do not change position (Figures 1 and 2). An 18 gauge, 9 cm, spinal-type procedure needle that can accommodate a guidewire (RO M004 4305 1 PERIVAC™, Boston Scientific, Inc. Natick, Massachusetts) was placed on a vascular syringe in a conventional fashion (Figures 3–5). Technique. After initial interrogation with two-dimensional echocardiography or fluoroscopy to determine anatomy and target area, the intended subxiphoid entry spot on the skin was marked with a surgical pen, and the skin cleaned with chlorhexidine antisepsis, being careful not to remove the entry point mark. A 5 ml vascular RPD filled with 2% lidocaine (Figures 1 and 2) and fitted with a 25 gauge, 1.5 inch safety needle is used to precisely control the needle while alternatively aspirating before injecting lidocaine (Figures 1 and 2). This is accomplished by depressing the aspiration plunger with the thumb to aspirate, and then depressing the injection plunger with the thumb to inject (Figures 1 and 2). The vascular syringe was used to infiltrate local anesthetic into the skin and the subcutaneous tissues. The pericardiocentesis needle with the stylet removed was placed on the 10 ml vascular syringe (Figure 3), and was advanced in the marked target at a 15-degree angle, while palpating the anatomy as necessary (Figures 3 and 4). If anesthesia was being administered, the thumb moved alternatively to the aspiration and injection plungers while alternatively aspirating and injecting lidocaine (Figures 1 and 2). The syringe can be held in the pencil grip with the free hand operating the aspiration-injection plungers or palpating anatomy (Figure 3), or the syringe can be held in a conventional syringe grip and the free hand controls and directs the needle or palpates anatomy (Figures 4 and 5). The syringe is then filled with pericardial fluid by pressing the aspiration plunger (Figure 5). For large effusions, the next step was placement of the guidewire into the hub of the procedure needle whose tip was now in the pericardial space after removing the vascular syringe from the needle hub. With the guidewire in place, the remainder of the procedure is fully conventional.^1–15 To date, we have performed 437 procedures with the vascular syringes under informed consent; all procedural complications and needlesticks to operators were recorded. Costs of a pericardiocentesis procedure in U.S. dollars ($) were determined as those costs reimbursed by 2010 Medicare (United States) national rates for HCPC/CPT codes 33010 for pericardiocentesis ($129.42); 76930 fluoroscopic guidance for a pericardiocentesis needle ($92.55); 75989 ultrasound guidance for a pericardiocentesis needle ($136.80); the price of a pericardiocentesis tray with catheter ($183 to $253 per tray); $1.50–1.95 for each vascular syringe; and $0.50 for each conventional syringe.23 Excess costs of a serious complication of pericardiocentesis were estimated by the known rate of serious pericardiocentesis complications (0.3–1.0%) and costs per serious procedural complication in the published medical literature.^{1–15,22–32}Determination of syringe and needle control in individual operators. The validated quantitative needle linear displacement method was used to measure the operator’s ability to control the needle tip ex vivo in both conventional syringes and vascular syringes.^18–20 This model measures loss of control in either the forward (unintended forward penetration of the needle tip) or reverse direction (unintended retraction of the needle tip). These variables have been validated to predict operator ability to control the needle, procedure time, procedure pain, needle trauma to patient tissues, hemorrhage and procedure outcome.^18–21 A rigid polystyrene marker is placed on the needle to a preset indelible mark on the needle, and then the needle is advanced until the polystyrene marker is touching the surface of the target tissue (Figure 6). The operator then performs the syringe procedure. Loss of control in the forward direction (penetration) pushes the polystyrene marker posteriorly on the needle past the indelible mark, permitting precise measurement in mm of loss of control. Loss of control in the reverse direction (retraction) lifts the polystyrene marker off the surface, exposing a length of the needle shaft (a “pull-back”), indicating loss of control in the reverse direction.^18–20 The needle is marked every 10 mm, which allows precise measurement of loss of control in either the forward or reverse direction. Twenty individual operators performed aspiration with 10 ml and 20 ml conventional and vascular syringes in each case, and the above parameters were measured. Statistical analysis. Data were entered into Excel and analyzed in SAS (SAS Institute, Inc., Chicago, Illinois). Primary comparisons between the vascular syringe and the conventional syringe of the outcome variables, unintended penetration (mm), unintended retraction (mm) and operator difficulty (0–10 analog difficulty scale) were compared post hoc with the Student’s t-test with confidence intervals at the 95% levels calculated. A power calculation was made using preliminary data at this level where a = 0.05.

Results

Direct comparisons of the ability of operators to control vascular syringes and conventional syringes are shown in Table 1. As can be seen, the 20 ml vascular syringe relative to the conventional 20 ml syringe reduced unintended forward penetration by 53% (10.1 ± 5.5 mm; p Discussion Pericardiocentesis, like all syringe and needle procedures, can result in significant complications including cardiac puncture, laceration of the coronary arteries, puncture of the left internal mammary artery, pneumothorax, pneumopericardium, hemothorax, mediastinitis and abscess — all potentially resulting in rapid cardiopulmonary arrest and death with subsequent medical malpractice claims, litigation and compensation actions.^1–15,22 Serious complication rates of pericardiocentesis range from 0.3–1.0%, and serious complications typically cost $7000–13,000 U.S. per complication.^6–8 During aspiration with a conventional syringe, a skilled operator may unintentionally advance the needle tip forward (unintentional forward penetration) as much as 20 mm; thus, this lack of needle control is clearly an undesirable characteristic of the conventional syringe, and has specifically been associated with increased tissue trauma and hemorrhage.^18–20 Even with a three-ring control syringe, it is often difficult to aspirate and generate vacuum without unintentionally advancing the needle tip, contributing to forward unintended penetration, tissue damage and hemorrhage.²⁰ Furthermore, most syringe handles and syringe pistols as needle control technologies are awkward during pericardiocentesis, and have never become popular; thus, most physicians still employ a conventional syringe despite the recognized inherent mechanical difficulties.²⁰ Although image guidance certainly reduces the rate of these complications, even minor complications in an already hemodynamically compromised cardiac patient can have disastrous consequences.^1–15 Vascular syringes have been demonstrated to consistently enhance needle control and reduce the complications of syringe and needle procedures.^16–20 Recent data suggest that this type of specialty syringe not only reduces complications, but also improves short- and long-term outcomes.^16–21 The vascular syringe, also known as the reciprocating syringe, is formed around the core of a traditional syringe barrel and plunger, but has an extra plunger and barrel (Figures 1–5).^16–21 The two plungers are mechanically linked in an opposing fashion by a pulley system, resulting in a set of reciprocating plungers so that unintended forward penetration is reduced, significantly improving the safety of the device (Table 1). Because of improved needle control, in clinical trials vascular syringes have been demonstrated to permit precise needle placement while decreasing the complications of syringe and needle aspiration procedures, including hemorrhage, by 40–60%.^16–21 Presently, vascular syringes cost $1.50–2.00, more than a conventional syringe ($0.50 to $1.00 per syringe). Despite the modestly increased cost ($1.00–1.50 per procedure), the vascular syringe technology is inexpensive compared to the overall costs of a pericardiocentesis procedure, including the pericardiocentesis needle ($8.00–20.00 per needle), a pericardiocentesis tray ($183.00–253.00 per tray), the pericardiocentesis procedure ($129.42), sonographic guidance ($136.80 per procedure), fluoroscopic guidance ($92.55 per procedure), costs per complication ($7000–13,000 per complication), or the global cost of a complication of pericardiocentesis averaged over all procedures ($21–130 per procedure)^23,31,32 Thus, use of a technology that costs $2.00 per procedure, but reduces procedural complications by 50%, would result in a cost saving of $10–65 per procedure, which far exceeds the cost of the technology.^1–32 Because of a consistent 40–60% reduction in complications and a 25–60% improvement in outcomes, there is a general consensus among patient safety experts that low-cost safety devices with a significant level of safety enhancement like the vascular syringe and safety needles should be integrated where feasible in the medical workplace, including physician-performed interventional procedures.^21–32Study limitations. Since serious complications of image-guided pericardiocentesis range from 0.3–1.0%, to demonstrate a significant 50% reduction in major complications of pericardiocentesis at the p 1–15 That being noted, there were no complications in this study. Recommendations concerning safety devices like the vascular syringe in specific procedures are often based on larger epidemiologic studies that incorporate multiple different procedures and device uses.^21–32

Conclusion

The present report demonstrates than vascular syringes, a patient safety technology, are significantly better controlled than conventional syringes, can be operated with one hand, perform well during image-guided pericardiocentesis and are estimated to save $10–65 in excess healthcare costs per pericardiocentesis procedure.

References

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———————————————————— From the ^aUniversity of New Mexico Health Sciences Center, Albuquerque, New Mexico; ^bHelena Pain Center, Department of Interventional Radiology, Helena, Montana; and ^cTexas Tech University Health Sciences Center, El Paso, Texas. Relevant disclosures: Dr. Sibbitt: stockholder and unpaid board member of Avasca, Inc. and Avanca Medical Devices, Inc.; stockholder in Surgin, Inc., Celgene, Inc., and Symatec Corp. Grants: National Institutes of Health and Public Health Service. This study is registered at clinicaltrials.gov, registration number is NCT00651625. Manuscript submitted July 20, 2010, provisional acceptance given August 16, 2010, final version accepted September 9, 2010. Address for correspondence: Wilmer L. Sibbitt, Jr., MD, University of New Mexico Health Sciences Center, Internal Medicine, MSC 10 5550, 5th FL ACC, University of New Mexico Health Sciences Center, Albuquerque, NM 87131. E-mail: wsibbitt@salud.unm.edu