Massive PE: Ecmo, Lysis, CDT or Embolectomy. When and What? Mahir Elder, MD, FACC, SCAI Clinical Professor of medicine Wayne State University-School of medicine Clinical Professor of medicine Michigan State University- Osteopathic School
Disclosures: Proctor Abiomed Proctor BTG
Pulmonary Embolism Patient risk stratification (per AHA 2011 guidelines) Massive PE Submassive PE Minor/Nonmassive PE High risk Moderate risk Low risk Massive 5% • Sustained hypotension • Systemically normotensive • Systemically normotensive ( systolic BP <90 mmHg for 15 (systolic BP 90 mmHg) (systolic BP 90 mmHg) min) • RV dysfunction • No RV dysfunction • Inotropic support • Myocardial necrosis • No myocardial necrosis • Pulselessness Nonmassive Submassive • Persistent profound 55% 40% bradycardia (HR <40 bpm with signs or symptoms of shock) RV dysfunction • RV/LV ratio > 0.9 or RV systolic dysfunction on echo • RV/LV ratio > 0.9 on CT • Elevation of BNP (>90 pg/mL) • Elevation of NTpro-BNP (>500 pg/mL) • ECG changes Goldhaber SZ, Visani L, De Rosa M, et al. for ICOPER. Acute pulmonary embolism; clinical outcomes in the International Cooperative Pulmonary Embolism Registry. Jaff et al. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and Lancet 1999;353:1386-1389 chronic thromboembolic pulmonary hypertension: A scientific statement from the American Heart Association. Circulation 2011;123(16):1788-1830.
Key factors contributing to HD collapse in acute PE Eur Heart J. 2014 Nov 14;35(43):3033-69
Recommendations Class Level PE with Shock or Hypotension PE with shock hypotension (high risk) It is recommended to initiate intravenous anticoagulation I C with UFH without delay in patients with high-risk PE. Thrombolytic therapy is recommended. I B Surgical pulmonary embolectomy is recommended for patients in whom thrombolysis is contraindicated or has I C failed. Percutaneous catheter-directed treatment should be considered as an alternative to surgical pulmonary IIa C embolectomy for patients in whom full-dose systemic thrombolysis is contraindicated or has failed. European Heart Journal (2014)
Treatment options for Massive PE: • Surgical intervention • Systemic anticoagulation RV mechanical • Systemic thrombolysis support • Catheter directed lysis
Surgical embolectomy • Massive or submassive PE with contraindication to lysis • Acute PE with RA thrombus or paradoxical embolism • Performed in only 1% of PE patients with massive PE and cardiogenic shock (based on the two largest PE registries) 1,2 • In 2013, nationwide large-sample analysis reported 27.2% inpatient mortality 1 • In 2018, mortality rate of patients treated with ECMO and surgical was 29%. 2 1 Goldhaber et al. Lancet 1999;353:1386-1389. 2 Kasper et al. J Am Coll Cardiol 1997;30:1165-1171 3 Kilic et al. J Thorac Cardiovasc Surg 2013;145:373-377 4 European heart journal 39.47 (2018): 4196-4204
J Thorac Cardiovasc Surg. 2018 Aug;156(2):672-681 VA ECMO is effective method to triage and optimize massive PE to recovery or intervention
Surgical embolectomy, (4) 31% Perfusion , 34 (1), 22-28.
Thrombectomy • AngioVac • AngioJet • Inari • Penumbra • EKOS*
Mechanical RV Circulatory Support • Impella RP • Tandem Heart-Protek • ECMO: V-A & V-V
Impella RP Indicated for providing circulatory assistance for up to 14 days in patients with a body surface area ≥ 1.5 m2 who develop acute right heart failure or decompensation following LVAD, myocardial infarction, heart transplant, or open-heart surgery.
RP Impella Sheath and Insertion
FDA Letter 4/2 /23 pa pati tients (17 (17%) ) sur surviv ival no no pa patie ients wit ith PE Late ins nsertio ion
FDA Letter 4/2 /23 pa pati tients (17 (17%) ) sur surviv ival no no pa patie ients wit ith PE Late ins nsertio ion Impella RP PMA study :18 – month Post approval study (42patients) – two categories Salvage support : > 48 hrs in cardiogenic shock from RV failure out of hospital arrest or transferred from multiple hospitals lifesaving for sickest patients Recover right protocol -73% survival rate ACC March 18 , 2019
Massive PE & RV Cardiogenic shock refractory to inotropes treated with RP Impella as bridge to recovery. Prior to Impella RP: all patients treated with EKOS/CDT. In patients with PE and RV shock, Impella RP device resulted in immediate hemodynamic benefit with reversal of shock and favorable survival to discharge. These findings support its probable benefit in this gravely ill patient population. J Interv Cardiol. 2018 Mar 7.
Massive PE & RV Cardiogenic shock refractory to inotropes treated with RP Impella as bridge to recovery. Prior to Impella RP: all patients treated with EKOS/CDT. In patients with PE and RV shock, Impella RP device resulted in immediate All patients survived to discharge. hemodynamic benefit with reversal of shock and favorable survival to discharge. These findings support its probable benefit in this gravely ill patient population. J Interv Cardiol. 2018 Mar 7.
Tandem Heart Common uses in Acute RV failure - Acute PE - RV infarction - RV dysfunction post-LVAD - ARDS Double or Single Venous Access - In-flow from right atrium - Out-flow into pulmonary artery
V-A and V-VA ECMO ECMO • V-V ECMO • Refractory respiratory failure • Modest cardiac or hemodynamic effects • RV and LV pre- and after-load largely unaffected • Potential decrease in RV afterload → improved oxygenation • V-A ECMO • Heart and Lung support • ↓RV pre -load and pulmonary flow • ↑ LV afterload and ↓ arterial pulse pressure Simon J. Finney Eur Respir Rev 2014;23:379-389
Tandem Heart Impella RP V-V ECMO V-A ECMO (Protek) Mechanism Micro-axial Centrifugal Centrifugal Centrifugal Cannula Size 24F Peel away, 9Fr catheter 29-31Fr Dual Lumen 31Fr Dual lumen or 18-22 Fr. Single 14-16 Fr Arterial in/outflow 18-21 Fr Venous Insertion Technique Single femoral vein, 9Fr Dual lumen IJ IJ dual lumen or fem vein and IJ Peripheral or Central catheter remains in vein Hemodynamic Support >4 L/min maximum flow Up to 5 L/min Up to 4.5L/ min (flow rate )* 5-7 L/min Implantation Time + +++ + ++ Device Preparation Time + ++ +++ +++ Anticoagulation ++ +++ +++ +++ Post Implant Management + ++ +++ +++ Hemolysis Risk + + ++ ++ Respiratory Support No Yes Yes Yes Risk of Hemolysis + + ++ ++ Pros Single access site ++Ambulate (neck) Oxygenation -+++ Hemodynamic support BiVAD possible with escalation + cath into PA Oxygenation +++ +Can add Oxygenator Can convert to V-A Cons No intrinsic oxygenator Long insertion time *No Hemodynamic support LV Distension ( against flow) High Transfusion rates Vascular complications, SIRS Transseptal (LA-FA bypass) Transfusion (bleed) 23Fr
Case
Case # presentation • Chief Complaint 53 year old female who presented with exertional dyspnea for 3 days. • History of Present Illness Recent admission for lower extremity cellulitis. finished two weeks course of cefipime and bactrim. • Physical examination Unremarkable aside of sinus tachycardia and tachypenic
Electrocardiogram Relevant lab results • Creatinine 1.1 mg/dL, normal electrolytes. • Troponin I- 1.34 ng. • BNP- 725 • Lactic Acid 2.9 mmoles/L. • CBC: • WBC 8.7 in mm3. • Hb 10.5 gr%. • PLT 252 in mm3. • Risk stratification: - Left axis. • PESI 109- moderate range. - Lack of classic S1Q3T3. • Modified PESI 8.9% risk of index admission + Sinus tachycardia. mortality. - No new RBBB. + Inverted T waves in V1-V3.
Echo
CT Scan and Pulmonary angiogram Severe RV enlargement: RV/LV ratio >> 0.9.
Right heart cath- First day of admission • RA: 16/18/17 mmHg. • RV: 40/10/20 mmHg. • PA: 39/23/30 mmHg. • PAPI: PA pulse pressure / mean RA = 0.94. • Cardiac output: 4.7 L/min. • Cardiac index: 2.15 L/min/m2. Catheter mediated thrombolysis- Two EKOS catheter based ultrasonic filaments were placed into the right and left main pulmonary arteries.
EKOS Endovascular System TWO 12 cm EKOS catheter - tPA infusion at 2 mg/hr (12 hr) followed by 1 mg/hr. Heparin administered systemically at 500 U/hr.
Hemodynamic deterioration- Third day of admission • Systolic blood pressure 86 mmHg / Heart rate 110 min • Reduced urine output. • Respiratory rate 36 min. • Hypoxic: SPO2 82% → intubated • Right heart catheterization: • RA: 19/24/23 mmHg. • RV: 42/11/26 mmHg. • PA: 41/28/33 mmHg. • PAPI: PA pulse pressure / mean RA = 0.56. • VA ECMO inserted
ECMO for 6 days • Marked hemodynamic improvement. • Right heart catheterization before ECMO removal: • RA 18/22/21 mmHg. • RV 49/14/20 mmHg. • PA 48/31/37 mmHg. • PAPI: 0.81 • Patient was discharged after 20 days of admission.
Echocardiography Post RV Support : Before RV Support: RV Support day 4: Severe RV dilatation with significant Severe RV dilatation with Severe RV dilatation with mild improvement in FAC reduction in FAC improvement in FAC
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