Safety and Efficacy of Ultrasound-Guided Thrombin Injections at

Safety and Efficacy of Ultrasound-Guided Thrombin Injections at the ‘Neck’ of Pseudoaneurysms Salem Badr, Vinay Gupta, Hironori Kitabata, Israel M. Barbash, Saar minha, , Lakshmana K Pendyala, Jousha P Loh, Rebecca Torguson, Fang Chen, William O. Suddath, Lowell F. Satler, Augusto D. Pichard, Ron Waksman, Nelson L Bernardo. Medstar Washington Hospital Center, Washington DC

Salem Badr, MD I/we have no real or apparent conflicts of interest to report.

Background Vascular Access Sites: Femoral artery Ø Most commonly used in the US Radial artery Distal pedal artery – DP, PT, Peroneal Brachial artery Popliteal artery Axillary artery Ulnar artery

Vascular Access for Catheterization Vascular access complications will happen Ø Diagnostic caths: 0. 8 - 1. 8% Ø Therapeutic/PCI: 1. 5 - 9% Factors: Patient, Anti-coagulation Tx, anti-platelet Tx, bigger sheath size, delayed sheath removal, etc. Complications lead to: Ø Morbidity/Mortality Ø Increased length of stay Ø Adds to health care cost

Complications: Femoral Artery Access Femoral artery complications: 2 -10% Complications: Ø Groin Hematoma (1 -10%) Ø Pseudoaneurysm (1 -6%) Ø AV fistula (<1%) Ø Retroperitoneal bleed (0. 1 -0. 9%) Ø Acute closure (<1%) Ø Dissection (intimal) Ø Vessel Laceration Ø Neural injury Ø Infection Ø Ø Venous thrombosis (+/right heart cath) Sheath/catheter clot

Pseudoaneurysm (PSA): False lumen that occurs at an arterial puncture site and contains active flowing arterial blood – ‘pulsatile hematoma’ False Aneurysm resulting from: Ø Penetrating or Blunt Trauma Ø Iatrogenic v Orthopaedic surgery, Arterial reconstruction v Arterial puncture site – ‘Low stick’, ? ? Hemostatic technique

Pseudoaneurysm (PSA): Signs & Symptoms Ø Pain Ø Tenderness +/- Ecchymosis Ø Pulsatile mass Ø + Systolic bruit Diagnostic tool Ø Ultrasound ‘duplex’ scan r/o concomittant A-V fistula

PSA: Duplex scan – CFA PSA R Common Femoral Artery PSA

Pseudoaneurysm (PSA): Tx Options Conservative Therapy Ø ‘Watch and Wait’ ~ < 2 -3 cm in size Ø 89% spontaneous closure in 2 months < 3 cm size and Asymptomatic Toursarkissian, B. et. al. J Vasc Surg 1997; 25(5): 803 -808. External Mechanical Compression Ø Application of Femo-stop Ø Painful and time-consuming Ø ? ? success rate

Pseudoaneurysm (PSA): Tx Options Ultrasound-guided Compression Ø Introduced in 1991 Fellmeth, B. et. al. Radiology 1991; 178: 671. Ø Painful and time-consuming (1 -2 hours) Ø Variable results ~ 74% effective Percutaneous Thrombin Injection Ø Treatment of choice Ø 2 -3% failure/repeat rate Ø Case selection to avoid catastrophy Ø Risk: Distal embolization

Pseudoaneurysm When do we treat PSA? Ø Symptomatic patients Ø PSA size > 2. 0 -2. 5 cm diameter Low threshold ~ on anti-coagulation ~ ? ? dual anti-platelet ~ ? ? follow-up compliance ~ complex PSA > 1 lobe

PSA: Percutaneous Thrombin Injection Equipments/Materials: Ø Ø Thrombin – reconstitute 1: 1000 units/ml and use tuberculin syringe Lidocaine – local anesthesia Spinal needle 21 gauge Trocar prevents insinuation of tissue into needle lumen 1 -2 cm of needle tip is “scored” by scalpel to make needle sonolucent Ultrasound machine + probe

Thrombin Injection of PSA: Step-by-step Check ABI (Ankle-Brachial index) Ø Baseline and post-injection Prep Groin Ø Betadine Ø Local anesthesia From Reeder, S. B. et. al. AJR 2001; 177: 595 -598.

Thrombin Injection of PSA: Step-by-step Correctly identify vessels/structures ? ? concomittant A-V fistula Check doppler flow signal of each structure

Thrombin Injection of PSA: Step-by-step Ideal PSA Morphology Ø ‘Long’ and ‘Narrow’ neck How ‘short is short’ or ‘wide is wide’ ? Ø Very subjective, operator-dependent

Percutaneous Thrombin Injection of PSA Make the neck ‘narrow’ Ø Ø Ø Inject normal saline to the neck region Watch the neck narrows ‘Enter’ PSA cavity and inject Thrombin From Finkelstein, A. et. al. Am J Cardiolo 2008; 1418 -1422

Thrombin Injection of PSA: Step-by-step Under direct ultrasound guidance, insert spinal needle Direct needle to the “neck” area

Thrombin Injection of PSA: Step-by-step Needle just above the ‘neck’ of the PSA

Successful PSA Thrombin Injection Check post-procedure ABI Repeat arterial duplex scan following morning

PSA: WHC Experience Between March 2008 and June 2012, 146 consecutive patients underwent thrombin injection for post PCI. Ninety-one patients had superficial thrombin injection (STI) and 55 patients had neck thrombin injection (NTI). STI NTI

PSA: WHC Experience Baseline characteristics for anti-platelet use, anticoagulation therapy given, number of lobes, length and width of neck of the PSAs were similar in both groups.

Variables Amount of thrombin[IU] Mean (SD) NTI (n = 56) 994. 55 (920) STI (n = 91) 1501. 52 (1384. 7) p value 0. 02 Neck length [mm]: min; max Mean (SD) 0; 2. 43 0. 76 (0. 56) 0. 13; 3. 3 1. 06 (0. 66) NS Neck width [mm]: min; max Mean (SD) 0. 1; 2. 0 0. 67 (0. 47) 0. 1; 2. 3 0. 78 (0. 47) NS Number of sacs: 1 2 3 37 (66. 1%) 15 (26. 8%) 4 (7. 1%) 57 (62. 6%) 28 (30. 8%) 6 (6. 6%) NS Success 56 (100%) 87 (96. 7%) NS 2 (3. 8%) 11 (12. 6%) NS Recurrence The NTI technique utilized lesser amount of Thrombin with a trend to a higher success rate and lesser recurrence.

In Summary: Successful vascular access with uncomplicated hemostasis of the access site is key to the success of any invasive procedure and avoid any access site complications. Thrombin injection at the “neck” of PSA is safe and efficacious in the treatment of femoral artery pseudoaneurysms. Proper training and case selection are critical to optimize outcomes and avoid complications.

Thank you