CVAD Selection and Tip Placement Overcoming Controversies with Evidence

Transcription

1 CVAD Selection and Tip Placement Overcoming Controversies with Evidence Scott O. Trerotola, MD Stanley Baum Professor of Radiology and Surgery Chief, Vascular and Interventional Radiology University of Pennsylvania Medical Center Financial Disclosures Consultant: MedComp, Teleflex, B Braun, Bard PV, Lutonix, Cook Royalty: Teleflex, Cook Other Hats Physician leader, Venous Access Team Collectively oversee ~4000 PICC+MLC/yr Vice Chair for Quality/Patient Safety and Quality Officer, Dept of Radiology the guy everyone calls when they want a PICC, and then again when the arm swells 2016 NHIA Annual Conference & Exposition 1

2 Objectives Describe the evidence supporting CVAD tip placement in adult and pediatric patients Explain how published outcomes of peripherally inserted central catheters are impacting best practices in CVAD selection and maintenance List and describe the goals of the Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) Tip position Major source of controversy Differing perspectives FDA vs MD vs RN vs patient Limited evidence basis Affects patient care on daily basis Delays in care most common Morbidity from high position Repeat procedures Problems with handoff to home infusion FDA position 1989: task force recommendation the catheter tip should not be placed in, or allowed to migrate into, the heart Based on 1970s and 1980s reports of perforations 2016 NHIA Annual Conference & Exposition 2

3 2001 K/DOQI guidelines Appropriate tip location of tunneled dialysis catheters is into the right atrium to ensure optimal blood flow Bolder than 1997 at caval-atrial junction or below Societal Recommendations AVA (as NAVAN) and INS pre Tip in lower 1/3 of SVC, ideally at caval-atrial junction Not in atrium INS 2016 J Inf Nursing 2016;39:S47 So, no change there 2016 NHIA Annual Conference & Exposition 3

4 INS 2016 J Inf Nursing 2016;39:S47 But some incremental progress here! Required reading: High tip position (SVC)=poor outcomes Schutz et al, JVIR 2004;15: ports graded by tip position at insertion 36% (SVC) vs 8% (upper RA) dysfunction (p=0.057) Puel et al, Cancer 1993; 72: ports 8/28 left sided catheters with tip in upper SVC/BCV developed symptomatic thrombosis 0/250 with tip in lower SVC Luciani et al, Radiology 2001; 220: Prospective US study 3/62 (5%) with tips at CAJ developed thrombosis 5/7 (71%) at SCV/BCV junction developed thrombosis Bansal et al JVIR 2008; 19: CVC needing t-pa Review of early malfunctioning CVC (<30d) showed 2/3 poorly positioned, all surgically placed After QA education re tip position to CAJ, 50% reduction in malfunction (p<0.001) and 50% decrease in suboptimal position (p<0.05) Just a few of many studies with same result 2016 NHIA Annual Conference & Exposition 4

5 High tip position (SVC)=poor outcomes Applies to non-tunneled devices as well Multiple studies summarized in Turcotte et al World J Surg 2006;30: show high PICC tip position associated w/thrombosis insufficient data to comment on CVC High tip position = poor outcomes-rct 37 PICC (silicone) randomized to central (SVC) or peripheral (axillosubclavian/innominate) clinical thrombosis 3/22 C vs 9/15 P, P<0.05 Thrombosis rate/100 wk 1.9 C vs 8.5 P, P<0.05 CV thrombus 5% C vs 56% P, P<0.05 No sig diff in phlebitis or infection Kearns et al JPEN 1996;20:20-24 Report: LIJ cath terminates at junction of LBCV and SVC Dangerous position 2016 NHIA Annual Conference & Exposition 5

6 Atrial Position is Safe Since 1997 K/DOQI, millions of 14-16F TDC placed with tip in RA, no perforations reported FDA now approves atrial tip position for TDC (Arrow-Clark) Ectopy is rare-~0.05% in Penn IR tunneled catheter database-all atrial position supine PICC Tips Move Generally, when arm is adducted, tip of PICC moves inward R>L Basilic>cephalic lower third (at best) Adducted Neutral Abducted Forauer and Alonzo J Vasc Interv Radiol 2000; 11: Port and Tunneled Catheter Tips Move Soft tissues of chest wall pull down on device, retracting tip Mean 3.2 cm in one study Obesity (M or F), large breasts increase effect Kowalski et al, J Vasc Interv Radiol 1997; 8: NHIA Annual Conference & Exposition 6

7 Catheter Tips Appear to Move Location of reference structure (heart) moves while tip stationary Supine to erect apparent retraction Deep inspiration apparent retraction Positioning of patient can affect Net Result No such thing as tip position Tip that looks perfect (CAJ) on erect, full inspiration chest radiograph is by definition in RA any time pt breathes normally or is supine and yet, it moves : attributed (probably incorrectly) to Galileo Impact on Patients Practitioners afraid to place tips in RA supine (mostly surgeons) by definition have malpositioned tips when pt is erect/sitting Well positioned devices reported as being in RA on CT (done supine) Both routinely delay infusion care High position results in new catheters/ports Friction b/infusion RNs, oncologists, venous access providers, and patients 2016 NHIA Annual Conference & Exposition 7

8 Catheter Tip Positioning: Summary Contentious, not fully resolved No such thing as a single tip position: tip uncertainty principle FDA: tip in SVC AVA (as NAVAN) + INS: tip in lower 1/3 of SVC, ideally at caval-atrial junction K/DOQI: TDC tip should be in RA Cardiologists: keep tip out of RA Growing body of evidence: high SVC position associated with poor outcomes My opinion, supported by extensive evidence: Tip should span caval-atrial junction on erect inspiratory film May need tip well into atrium when supine Report: Tip at caval-atrial junction Tip Position: Summary In fact, nearly ALL modern complications of CVC are associated with HIGH position (including upper 2/3 of SVC) considered acceptable by many Atrial tip position in widespread use since K/DOQI (1997) with no increase in complications despite large catheters (TDC) Tip Position: Summary By far, greatest area of opportunity to reduce thrombosis-related (and by extension infectious) morbidity in venous access: low-hanging fruit Why have we not resolved this? Every day event-malposition related morbidity SVC position of any kind is detrimental Caveat-very small children OK, I ll get off the soap box now 2016 NHIA Annual Conference & Exposition 8

9 Caveat re Pediatric Patients Limited data in pediatric patients Thin walled atria vis-à-vis catheter especially in neonates, very young Older children-tdc in RA routinely Serious Complications: Malpositioned Right Atrial PICC 30+ minute arrest TPN pericardial tamponade Survived c/o Neil Johnson, Cincinnati Children s Hospital Caval-Atrial Junction CARINA level Caval-Atrial Junction 2 V.U. CARINA Lateral Chest CT c/o Neil Johnson, Cincinnati Children s Hospital 2016 NHIA Annual Conference & Exposition 9

10 Caval-Atrial Junction Where (most)radiologists think it is on a radiograph Where it IS c/o Neil Johnson, Cincinnati Children s Hospital c/o Neil Johnson, Cincinnati Children s Hospital PICC Outcomes-The Good and the Bad (there s no Ugly) PICC explosion great for patients, hospitals Current delivery system (RN w/ir backup) works well Low infection rate, home In-hospital can be improved Thrombosis rates under scrutiny 2016 NHIA Annual Conference & Exposition 10

11 Nontunneled Catheters 400, , , , , ,000 Radiology Anesthesiology Surgery All other groups aggregated 100,000 50,000 0 Duszak et al, JACR 2013;10: All venous access devices cause infection, with varying morbidity PICC (much) less so 2016 NHIA Annual Conference & Exposition 11

12 All venous access devices cause thrombosis and/or stenosis, with varying morbidity PICC (much) more so Present focus is on thrombosis, before long it will be back to infection 2016 NHIA Annual Conference & Exposition 12

13 Caveat PICC and MLC (of same Ø) have same local thrombosis risk More important to some than others MLC does not risk central venous thrombosis (more likely to be symptomatic) Will discuss MLC/PICC together as relates to thrombosis Judicious use of VAD Consider alternatives such as: Oral medications Enteral feeding Delivery of agents through existing devices, eg dialysis catheters during dialysis More efficient use of existing device(s), ie do you really need additional lumens Milrinone TPN dedicated lumen Or in anyone who may need hemodialysis in the future 282 HD pts evaluated for prior PICC 120 w TDC or graft (cases), 162 w AVF (controls) Overall 30% had had PICC, half before HD start 44% of cases had had PICC vs 20% of controls, P<0.001 Independent of other variables, PICC predictor of TDC/graft vs AVF Venous mapping results compared Mean vein diameter smaller post PICC Very strong support for SBCC program Why? 2016 NHIA Annual Conference & Exposition 13

14 VAD-related Venous Thrombosis diameter, thrombosis rate Caveat-for given catheter Ø, lumen number probably does not affect thrombosis rate and may or may not affect infection rate Grove and Pevec JVIR 2000;11: Retrospective study PICC diameter strongest predictor of thrombosis Symptomatic thrombosis only 3F-0%, 4F-1%, 5F-6.6%, 6F-9.8% 4F-5F difference significant p< F-6F significant p= Most events in first 2 weeks Penn TLP study 6F TLPICC (tapered), n=52, US in 45 All ICU pts Symptomatic and asymptomatic DVT 58% DVT overall 42% extensive 20% symptomatic No CRBSI 3 colonization in 29 tips cultured (10%) Abandoned 6F TLP as a result (study aborted early due to high DVT rate) Positive impact on design! Trerotola et al, Radiology 2010;256: NHIA Annual Conference & Exposition 14

15 Intermountain study 2014 PICC in 1728 pt Symptomatic DVT 4FSL 0.6%, 5FDL 2.9%, 6FTL 8.8% Examined 20 risk factors for symptomatic DVT Prior DVT (OR 9.92, p<0.001) 5F double lumen (OR 7.54, p<0.05) 6F triple lumen (OR 19.50, P<0.01) Nearly all reverse taper design Did not examine relationship of vein size to DVT, did not place TLP in vein <0.5 mm Accepted ANY SVC tip position, did not relate to DVT Evans et al, Chest 2010;138: Study of US-confirmed sx PICC-related DVT, n=268 compared to 641 controls Risk factors for DVT h/o VTE (OR 1.7, P=0.041) PICC in place during surgery (OR 2.17, P=0.014) Larger diameter PICC (4F reference) 5F (OR 2.74, P=0.128) 6F (OR 7.4, P=0.003) Vein choice (basilic reference) Brachial (OR 6.75, P<0.001) Cephalic (OR 5.75, P<0.001) IR placement (OR 7.13, P<0.001) 82.5% of PICC removed (!) within 24 hr of dx ASA + statin decreased risk-needs validation Chopra et al, Thrombosis Res 2015;135: Penn TAPER study RCT tapered (Bard, n=168) vs non-tapered PICC (Arrow, n=164) Tapered inserted to zero mark, NT hubbed Ultrasound FU at 28d or removal Overall thrombosis rate 72% Higher in cancer pts 72% vs 67%, P=0.002 All 5F DL devices bedside and IR No difference in bleeding or ease of insertion Itkin et al, JVIR 2014;25: NHIA Annual Conference & Exposition 15

16 Overall thrombosis Symptomatic thrombosis Complete thrombosis Nontapered Tapered P 70.4% 73.4% % 3.6% 0/ % 20.8% 0.44 *Seemingly contradicts Pittiruti s rule Itkin et al, JVIR 2014;25:85-91 Important distinction US surveillance vs symptomatic thrombosis Tip of the iceberg Future studies should use US Proxy for sx thrombosis Similar to colonization and CRBSI Reducing VAD-related Venous Thrombosis No need for devices >5F Below 5FDL and 4FSL, lumen diameter becomes problematic (adults) In some applications 4FDL/5FTL may be OK Use smallest device/biggest vein possible Limit use of DL devices* Decision support in EMR, SL default (4F) Q4 FY13 (pre) 10% SL (n=149-ir only) Q2 FY14 (post) 30% SL (n=162-ir only) VAT 10% to 17% same time frame, now 25% Use MLC if PICC not needed Reduce sx thrombosis, less vein at risk Last/not least-proper tip positon *Evans et al, Chest 2013;143: , O Brien et al JACR 2013;10: NHIA Annual Conference & Exposition 16

17 Managing VAD-related Venous Thrombosis Once the vein is thrombosed, it is unusable Unknown how many recover Still diseased if recanalized Thrombosis occurs early Thrombosis virtually never affects PICC function Prior DVT high risk for another (Evans 2010) Managing VAD-related Venous Thrombosis 2012 ACCP guidelines-maintain venous access device when thrombosis occurs (2C evidence) Rationale-vein is lost, AC needed anyway, PICC still works Unknowns-PE risk, duration of AC Penn RCT attempt failed ACCP already adopted in spite of weak evidence Good, however unsure if widely practiced Guyatt et al, Chest 2012;141:7s-47s Venous thrombosis Symptomatic? Yes No Keep catheter* Anticoagulate if appropriate Yes Symptoms resolved? No Yes Keep catheter* Anticoagulate if appropriate Septic thrombophlebitis? SVC syndrome? No Catheter needed? Other access sites available? No Yes Yes No Yes Consider thrombolysis Immediate removal Antibiotics Anticoagulation Elevate involved extremity Consider thrombolysis Remove catheter Anticoagulate Remove catheter Place new catheter Anticoagulate if appropriate Management of catheter-related venous thrombosis *2012 ACCP guidelines (2C) 2016 NHIA Annual Conference & Exposition 17

18 Luminal Occlusion Often readily remediable at bedside Provided PICC is made of PU 1-3 ml polycarbonate syringe Nearly 100% effective Routinely used for repo 70% effective No rupture VAD-related Venous Thrombosis: Summary VAD-related DVT is common and presently inevitable: DVT can be reduced Smaller devices Possibly coatings in future Don t place VAD if not necessary or appropriate VAD-related DVT is not the end of that veindevice relationship: use OTWE to maintain as long as needed MAGIC Multidisciplinary expert panel Large number of scenarios reviewed with focus on PICC/MLC Evidence based recommendations 2016 NHIA Annual Conference & Exposition 18

19 MAGIC Goals Reduce practice variation Guide appropriate use of VAD Emphasis on PICC/MLC Reduce complications/improve safety Inform QI initiatives MAGIC Methods Expert panel, n=15 including a patient RAND/UCLA appropriateness methodology Extensively used, validated, well accepted 665 scenarios reviewed independently In-person meeting for consensus Developed recommendations for when it is appropriate to use a PICC vs. other device Appropriateness based on risk/benefit ratio, regardless of cost (per the methodology) 2016 NHIA Annual Conference & Exposition 19

20 MAGIC Methods Sections on insertion, care, maintenance Included unique, distinct populations Hospitalized medical patients CKD, cancer, critical illness Special populations: nursing home, long term IV If not PICC, then what? Included areas of controversy and ambiguity Top 10 lists from panelists Panel Ratings Per RAND/UCLA method, a scale of indicated harm >> benefits 9 indicated benefits >> harm Middle rating of 5: harm = benefit or panelist cannot make an informed decision Median ratings on opposite ends of scale (eg 1-3 or 7-9) used to indicate appropriateness across all panelists 2016 NHIA Annual Conference & Exposition 20

21 Example Rating Scenario All scenarios pilot tested with clinicians who did not take part in the panel Insertion Practice 2016 NHIA Annual Conference & Exposition 21

22 Peripheral IV 2016 NHIA Annual Conference & Exposition 22

23 MAGIC: Summary Fantastic resource Needs full implementation May PICC paradoxically Much more work to do 2016 NHIA Annual Conference & Exposition 23