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focus: L’Embolia Polmonare
Dott. Gabriele Crimi
Cardiologo Interventista
IRCCS Policlinico San Matteo, Pavia, Italy
Cuore e non solo
Sciogliere o togliere il trombo?
Genova, 27.01.2018
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DISCLOSURE INFORMATION
Dott. Gabriele Crimi
negli ultimi due anni NON ho avuto rapporti anche di
finanziamento con soggetti portatori di interessi
commerciali in campo sanitario
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Embolia Polmonare (EP)
Incidenza annuale
– ≈300,000 casi/anno in UE1
– ≈ 15% delle morti ospedaliere sono causate o concausate da PE2
– EP terza causa di morte dopo infarto miocardico e stroke
Trombo-embolismo venoso
– Embolia polmonare (EP) generalmente origina da trombosivenosa profonda (TVP) • ≈ 80% con EP hanno evidenza di TVP
• EP si verifica nel ≈ 50% dei pazienti con trombosi prossimale
– EP complica allettamenti prolungati, degenze oncologiche post-chirurgiche, scompenso cardiaco
Torbicki et al. Eur Heart J 2008;29: 2276–2315 Kasper et al. J Am Coll Cardiol. 1997;30:1165-1171
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EP: Stratificazione prognostica
Goldhaber et al. Lancet 1999;353:1386-1389
Massiva EP [Alto rischio]
58% mortalità @ 3 mesi
Submassive EP
[Rischio intermedio]
10% mortalità @ 3 mesi
Minore EP
[basso rischio]
<2% mortalità @ 3 mesi 55% 5%
40%
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Sovraccarico RV e prognosi
• Il sovraccarico RV si associa a incremento di mortalità anche in pazienti emodinamicamente stabili1
• Un rapporto RV:LV >0.9 in pazienticon EP è un predittore indipendentedi mortalità2,3
1. Goldhaber S, Visani L, DeRosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). The Lancet; Apr 24,1999; 353,9162; Health Module pg. 1386.
2. Fremont et al. Prognostic Value of Echocardiographic Right/Left Ventricular End-Diastolic Diameter Ratio in Patients with Acute Pulmonary Embolism. CHEST 2008; 133:358-362.
3. Van der Meer et al. Right Ventricular Dysfunction and Pulmonary Obstruction Index at Helical CT: Prediction of Clinical Outcome during 3-month Follow-up in Patients with Acute Pulmonary Embolism. Radiology 2005; 235:798-803.
Cuore e non solo
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EP: Stratificazione prognostica
ESC Guidelines Pulmonary Embolism 2014
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EP trattamento
Modified from ESC Guidelines Pulmonary Embolism
Alto rischioRischio
intermedio-altoRischio
intermedio-bassoBasso rischio
Terapia anticoagulante (AC)
• LMWH/Fondaparinux Classe IA e TAO (INR 2-3) Classe IB *• NAO (Rivaroxaban, Apixaban, Dabigatran, Edoxaban) Classe IB
* UH + TAO in pazienti con insufficienza renale cronica o alto rischio
Terapia AC +Terapia Riperfusiva• Trombolisi
Classe IB• Trans-catetere
Classe IIaC• Chirurgica
Classe IC
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Vantaggi terapia riperfusiva
Ridurre le dimensioni del trombo
• Migliorare la portata polmonare
-> V/Q scambi alveolari
• Ridurre sovraccarico pressorio ventricolare destro
-> shock
• Ridurre il rischio di sviluppare ipertensione polmonarecronica
-> Limitazioni funzionali, sequele
Piazza and Goldhaber. Vascular Medicine 2010 15(5):419-428
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Limiti terapia riperfusiva ev
Trombolisi sistemica
• In studi randomizzati1
– 13% di eventi emorragici maggiori
– 1.8% of emorragia intracranica
• Nel mondo reale2
– 20% di major bleeding
– 3% di emorragia intracranica
• Il rapporto rischio/beneficio della trombolisi sistemica è vantaggioso nei pazienti ad alto rischio (mortalità >20%) ma non in qualli a rischio intermedio
1. Eur Heart J 2008: 29:2276-2315 2. Am J Cardiol. 2006;97:127-9
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Limiti terapia riperfusiva ev
N=72,230 pazienti 1999-2008
EP + shock o supporto ventilatorio
Stein PD. Thrombolitic Therapy in Unstable Patients: Saves Lives but Underused. AJM 2012;125:465-70
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Controindicazioni a tpriperfusiva ev
ESC Guidelines Pulmonary Embolism 2014
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Riperfusione trans-catetere
ESC Guidelines Pulmonary Embolism 2014
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Angiojet 8F Zelante DVT system
www.bostonscientific.com/en-US/products/thrombectomy-systems/angiojet-ultra-coronary-thrombectomy-system.html
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Angiojet caso clinico
• NA, donna 48 anni
• BMI >35
• Sincope -> 118 PEA -> EP
• Esclusa trombolisi per abbondante menorragia
• Esclusa chirurgia per condizioni emodinamiche labili
• ECMO e riperfusione trans-catetere
Cuore e non solo
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Angiojet caso clinico
Cuore e non solo
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Angiojet caso clinico
Cuore e non solo
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Angiojet caso clinico
Cuore e non solo
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Angiojet FDA blackbox
Cuore e non solo
” It appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks “
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Trombolisi loco regionale adiuvata da catetere a ultrasuoni EkoSonic
Infusion Catheter
Ultrasonic Core
Cuore e non solo
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EkoSonic
20Braatan et al. Thrmob Haemost 1997;78:1063-8.Francis et al. Ultrasound in Medicine and Biology, 1995;21(5):419-24.Soltani et al. Physics in Medicine and Biology, 2008; 53:6837-47.
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EkoSonic
21Braatan et al. Thrmob Haemost 1997;78:1063-8.Francis et al. Ultrasound in Medicine and Biology, 1995;21(5):419-24.Soltani et al. Physics in Medicine and Biology, 2008; 53:6837-47.
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ULTIMA study: RCT efficacia vs UH
SEATTLE II study: 1 arm study efficacia e sicurezza
OPTALYSE PE study: dose finding
EkoSonic evidenze scientifiche
Cuore e non solo
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EkoSonic ULTIMA study
Kucher et al. Circulation. 2014;129:479-486
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EkoSonic ULTIMA study
Kucher et al. Circulation. 2014;129:479-486
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EkoSonic SEATTLE II study
Piazza G. et. al. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-92. doi: 10.1016/j.jcin.2015.04.020.
Ultrasound-facilitated fibrinolysis using EKOS®
– If unilateral PE: tPA 1 mg/hr using one device for 24 hours
– If bilateral PE: tPA 1 mg/hr per device (using two simultaneously) for 12 hours
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EkoSonic SEATTLE II study
Piazza G. et. al. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-92. doi: 10.1016/j.jcin.2015.04.020.
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EkoSonic SEATTLE II study
Piazza G. et. al. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-92. doi: 10.1016/j.jcin.2015.04.020.
Clinical outcomes* N = 150
Mean length of stay ± SD, days 8.8 ± 5
In-hospital death, n (%) 3 (2)
30-day mortality**, n (%) 4 (2.7)
Serious adverse events due to device, n (%) 2 (1.3)
Serious adverse events due to t-PA, n (%) 2 (1.3)
IVC filter placed, n (%) 24 (16)
Major bleeding within 30 days**, n (%)
GUSTO moderate**
GUSTO severe**
17 (11.4)
16 (10.7)
1 (0.7)
Intracranial haemorrhage, n (%) 0 (0)*All death, serious adverse and bleeding events were adjudicated by an independent safety monitor
**N = 149 (1 patient lost to follow-up)
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EkoSonic OPTALYZE PE study
Piazza G. “A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary
Embolism (SEATTLE II).” American College of Cardiology 63rd Annual Scientific Session, Washington DC, March 30, 2014.
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EkoSonic OPTALYZE PE study
Piazza G. “A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary
Embolism (SEATTLE II).” American College of Cardiology 63rd Annual Scientific Session, Washington DC, March 30, 2014.
4-8 mg r-tPA
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EkoSonic CE and FDA approved
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• EP a rischio basso/intermedio -> AC
• EP a rischio intermedio/alto-> rTPA + AC
– La trombolisi sistemica ha limiti e complicanze severe
– Terapie trans-catetere sono efficaci e sottoutilizzate
Sciogliere o togliere il trombo?
Cuore e non solo
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focus: L’Embolia Polmonare
Cuore e non solo