Alternatives to CDT: Half-dose Thrombolytics and Mechanical - - PowerPoint PPT Presentation

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Alternatives to CDT: Half-dose Thrombolytics and Mechanical - - PowerPoint PPT Presentation

May 06, 2023 390 likes •761 views

Alternatives to CDT: Half-dose Thrombolytics and Mechanical Thrombectomy Thomas Tu, MD FSCAI, FACC The Dawn of A New Era of PE Therapy A Sunrise Pulmonary Embolism Symposium May 22, 2019 Disclosures None currently As of July 1, 2019,

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Alternatives to CDT: Half-dose Thrombolytics and Mechanical Thrombectomy

Thomas Tu, MD FSCAI, FACC The Dawn of A New Era of PE Therapy A Sunrise Pulmonary Embolism Symposium May 22, 2019

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Disclosures

  • None currently
  • As of July 1, 2019, I will be employed by Inari Medical as Chief

Medical Officer

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Case Presentation

  • 68 year old man POD 2 from resection of brain tumor
  • Acute respiratory decompensation
  • Intubated on 100% FiO2, Arterial O2 sat 90%
  • CT demonstrates saddle pulmonary embolism with RV/LV ratio 1.8
  • Troponin 1.4, BNP 4500
  • His HR is 110, BP 100/60 on low dose levophed
  • The neurosurgeon states that there is an absolute contraindication to

thrombolytic administration in this patient

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Contraindications to Thrombolytics

Absolute:

  • History of hemorrhagic stroke
  • Active intracranial neoplasm
  • Recent (<2 months)

intracranial surgery or trauma

  • Active or recent internal

bleeding in prior 6 months Relative:

  • Bleeding diathesis
  • Uncontrolled severe

hypertension

  • Cardiopulmonary resuscitation
  • Nonhemorrhagic stroke within

prior 2 months

  • Surgery within the previous 10

days

  • Thrombocytopenia (plts <

100,000)

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Why Consider Alternatives to CDT

  • Contraindications to thrombolytic therapy
  • Urgent need for restoration of pulmonary blood flow
  • Patient “too sick” to be sent for catheter-procedure
  • Clinical equipoise about benefits of CDT
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Low Dose Thrombolysis of PE

Am J Cardiol 2013;111:273-277

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MOPETT Conclusions

  • Half dose thrombolytics seemed to lower pulmonary hypertension

and possibly recurrent PE compared to control

  • Bleeding rates seemed to be acceptably low
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Crit Care Med 2018; 46:1617–1625

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Conclusions from Kiser

  • 46% of patients treated with half dose t-PA did not require further

intervention

  • A higher percentage of those treated with half dose required

treatment escalation compared with full dose

  • Bleeding rates were similar between doses (~0.5 % ICH, 6-7% ABLA)
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Conclusions: Half Dose t-PA

  • Small studies suggest that it may or may not be as effective as full

dose t-PA

  • Bleeding rates are variable, but catastrophic bleeding still a concern
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Mechanical Thrombectomy

  • Acute clot removal without the risk of thrombolytic administration
  • Rapid onset of effect
  • Reduction in patient acuity and post-treatment intensity of care
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Penumbra

  • Indigo System
  • Adapted from neurointervention
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EXTRACT-PE Trial

  • Evaluating the Safety and Efficacy of the Indigo Aspiration System in

Acute Pulmonary Embolism

  • PI: Dr. Akhilesh Sista
  • 150 patients
  • Efficacy Endpoint: RV/LV ratio improvement at 48 hours
  • Safety Endpoint: Major adverse events
  • Estimated enrollment completion: Q4 2019
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Fl FlowTriever De Devic ice (“FT FT”) Aspiration Guide Catheter (“AGC”) Retraction Aspirator (“RA”)

  • Navigates through the right heart

and delivers FT device to the pulmonary artery

  • Large bore catheter maximizes

aspiration and collection of thrombus

  • Deployed out of AGC and

into thrombus

  • Disrupts, engages and

moves large volume of thrombus

  • Retracts the FT with

thrombus into the AGC

  • Synchronizes aspiration

and retrieval

Dis Disru ruption, mac aceration an and retri rieval of

  • f clot

clot In Increased ed lu lumen Rapid id flo flow res estoration R Red educed PA pressure e R Red educed ed RV str train in

FlowTriever System – First Generation

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  • Objective
  • Evaluate the safety and effectiveness of the FlowTriever System for

use in the removal of emboli from the pulmonary arteries in the treatment of acute PE

  • Study Design
  • Prospective, single-arm, multicenter study
  • 106 patients, 18 sites
  • Follow-up at 48-hours & 30-days
  • Primary endpoints
  • Effectiveness – reduction in RV/LV ratio at 48-hours
  • Safety – Composite major adverse event rate

FLARE Study Overview

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Major Adverse Event Definition

  • Device-related death
  • Major bleeding (VARC-2 definition)
  • Treatment-related adverse events:
  • Clinical Deterioration
  • Pulmonary vascular injury
  • Cardiac injury
  • All endpoints are measured within 48 hrs ± 8 hours
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Baseline 48 Hour Reduction p All Patients (N=106) 1.53 1.15 0.39 p <0.0001 All Paired Patients (N=103) 1.54 1.15 0.39 p <0.0001 Paired Patients w/o Lytic (N=101) 1.54 1.15 0.38 p <0.0001

RV/LV Ratio Outcomes

1.53 1.15 0.00 0.50 1.00 1.50 2.00 Baseline 48-Hour RV/LV Ratio

RV/LV Ratio All Patients (N=106)

Reduction 0.39 p <0.0001

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FlowTriever Clot Retrieval Experience, Acute to Chronic

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ACUTE CHRONIC

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ICU stay post-procedure, median 1 day ICU stay: distribution 0 = 44 1 = 23 2 = 18 3+ = 21 Days to discharge post-procedure, median 3 days # Patients lost-to-follow-up 2 # Patients any-cause mortality 1 # MAEs* 4 (ITT 3.8% , mITT 3.8%)

Clinical Outcomes

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Major Adverse Events

  • No intracranial hemorrhage
  • No access-site major bleeding
  • No device-related death
  • No device-related pulmonary injury
  • No device-related cardiac injury
  • One patient had a bleeding event
  • Three patients had treatment-related clinical deterioration
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FLARE Effectiveness in Context

N Treatment tPA Reduction in RV/LV Ratio at 48 Hours FLARE 104 FlowTriever mechanical thrombectomy 0 mg 0.39 / 25% SEATTLE II (2015) 150 USAT 24 mg 0.42 / 24% ULTIMA (2014)* 30 USAT arm 10-20 mg 0.29 / 22% Becattini et al (2010) 28 Systemic Thrombolytic 30-50 mg 0.31 / 24% Fasullo et al (2011) 35 Systemic Thrombolytic 100 mg 0.40 / 27% Mi et al (2013) 57 Systemic Thrombolytic 50 mg 0.11 / 8%

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*RV/LV Ratio in ULTIMA measured at 24 hours

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FLARE Safety in Context

Stu Study Majo ajor Bl Bleedin ing In Intr tracrania ial l He Hemorrhage (Fib (Fibrinoly lysis is Gr Group) FLA FLARE 1/ 1/106 (.9% (.9%) 0/ 0/106 (0% (0%) UL ULTIMA (US (USAT ar arm) (Kucher, , et al

  • al. 2013

2013) 0/ 0/30 (0% (0%) 0/ 0/30 (0% (0%) PE PEITHO (tPA ar arm) (M (Meyer G, G, et al

  • al. 2014

2014) 58/5 58/506 (11.5 (11.5%) 10/5 10/506 (2% (2%) SE SEATTLE II II (Pia (Piazza G, G, et al

  • al. 2014

2014) 17/1 17/150 (11.4 (11.4%) 0/ 0/150 (0% (0%)

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Evolution of Flowtriever

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10 20 30 40 50 60 70 80 90 100 16:59 17:04 17:09 17:14 17:19 17:24 17:29 17:33 17:39 17:44 17:49 17:54 17:59 18:04

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SpO2 (%)

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Hemodynamic Results

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PRE POST PA Pressure: 57/23/35 35/20/25 PA Sat: 25% 63%

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Conclusions

  • Pulmonary embolism remains a complex disease state
  • Multiple options exist for treatment
  • Considerations for choice of therapy should include:
  • Patient clinical status (signs of RV strain and hemodynamic compromise)
  • Thrombus burden/location
  • Bleeding risk
  • Goals of therapy
  • Access to technology and catheter skill sets
  • I predict strong growth in catheter-based intervention for PE due to

improving technologies and results of ongoing research