2. Pulmonary Embolism Resolved with Site Specific Thrombolysis via Drug Delivery Catheter Michael Nuyles, DO Interventional Cardiology Fellow Midwestern University Franciscan Alliance – Olympia Fields, IL Michael Nicholas, DO, FACC, FACOI Interventional Cardiology Program Director

3. Disclosures None $265,000 USD in medical school loans

4. Active, 81 year old Caucasian Female presented with progressive debilitating dyspnea on exertion, chest tightness, and lightheadness.

5. Case Presentation Medical History: – HTN, Dyslipidemia, Mild TR (prior ECHO 2008) Surgical History: – Hysterectomy Social History: – Lifelong non-smoker, no EtOH/Illicits – Avid bicyclist, exercises daily

6. Meds: – Simvastatin, ASA, Amilodipine, Atenolol Family History: – No Hx of malignancy or coagulopathy Physical Exam: – Afebrile, BP121/84, HR 81, RR 24, 94% on 4 liters O2 nasal cannula – CVS: RR, S1, S2 positive Carvallo’s Sign – Lungs: CTA – EXT: Tr Edema

7. CT Angiography and Echo CTA Chest: Extensive bi-lateral pulmonary emboli upper and lower lobe ECHO: - RV mod/severely dilated with reduced systolic function - Mod/severe TR - RVSP 57.1 mmHg

9. Procedural Course 7Fr sheath via Right Internal Jugular Vein 7Fr Ansel 1 Flexor peripheral sheath Terumo ™ Glidewire-angled-stiff 180 cm Guidewire 5Fr. Pigtail catheter with attempted unsuccessful mechanical thrombolysis

10. Modern CDT vs. Systemic tPA (for Treatment of Acute PE) Mortality from PE Major Complications Cerebral Hemorrhage Modern CDT Meta-Analysis 2008 n = 308 12%2.3%* (7/308) 0% Systemic tPA ICOPER 1999 n = 304 23%21.7%** (66/304) 3% (9/304) *Includes 1.3% major hemorrhages. **All were major hemorrhages. Courtesy of Anthony Venbrux, MD

18. Intra-clot administration of tissue plasminogen activator (tPA) into the pulmonary arteries 8 mg total using a ClearWay™ drug delivery balloon OTW 4.0 x 20 mm Procedural Course

19. Pre and Post tPA Pulmonary Artery Pressures Pre Intervention ECHO Post Intervention ECHO- Day 9 Pre tPA InfusionPost tPA Infusion Pulmonary Artery Pressure58/22 mean of 32 34/10 mean of 20 Right Atrial Pressure3 with a negative Kussmaul RVSP58 with a RDEVP of 7 Wedge15

20. Case Summary Significant improvement of functional status and by echocardiographic evaluation Hemodynamically stable post tPA infusion Improved saturation requiring no supplemental oxygen 4 days post tPA infusion Ambulated well with cardiac rehab services within 2 days post tPA infusion Discharged home on Day 14 once INR therapeutic

22. Conclusion Significant risks associated with large boluses of tPA needed to resolve clot Drug Delivered via Guide Catheter may not be adequate for dissolution of heavy thrombus burden Site specific drug delivery is effective in quickly resolving pulmonary embolism with less drug utilized Intra-clot delivery via an atraumatic drug delivery balloon holds great promise for managing thrombus burden and improving lung function

23. Thank you!