A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism

Piazza, Gregory; Hohlfelder, Benjamin; Jaff, Michael R.; Ouriel, Kenneth; Engelhardt, Tod C.; Sterling, Keith M.; Jones, Noah; Gurley, John C.; Bhatheja, Rohit; Kennedy, Robert J.; Goswami, Nilesh; Natarajan, Kannan; Rundback, John H.; Sadiq, Immad; Liu, Stephen K.; Bhalla, Narinder; Raja, M. Laiq; Weinstock, Barry S.; Cynamon, Jacob; Elmasri, Fakhir; Garcia, Mark J.; Kumar, Mark H.; Ayerdi, Juan; Soukas, Peter; Kuo, William T.; Liu, Ping-Yu; Goldhaber, Samuel Z.; Investigators, Seattle Ii

doi:10.1016/j.jcin.2015.04.020

Cited by 769 publications

(612 citation statements)

References 30 publications

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“…56,57 This combination offers an immediate hemodynamic effect, because the thrombus is ruptured mechanically, combined with a higher concentration of the fibrinolytic agent at the site, avoiding the systemic action of fibrinolytic therapy and reducing the risk of major bleeding. [58][59][60] The SEATTLE II study of 150 patients with massive or submassive PTE treated with 20 mg of rtPA demonstrated correction of RV dysfunction and of PH within 24 h in 30% of them, with no CNS bleeding, 61 and the ULTIMA study, with 59 patients, also observed rapid improvement in parameters of RV dilatation without major bleeding (just 3.6% minor bleeding). 62 The limitations of this technique are the need for a specialized team, the cost of the material, and as-yet scant scientific evidence, 21,40 which restricts its use to patients who will not respond well to systemic treatment.…”

Section: Patients With Submassive Pte (Moderate Risk)mentioning

confidence: 99%

Terapia fibrinolítica sistêmica no tromboembolismo pulmonar

Ceresetto

Marques

2017

J. vasc. bras.

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Pulmonary thromboembolism remains a major therapeutic challenge for specialists and, despite investment and the consequent developments in diagnosis, prophylaxis, and treatment, the condition is still the leading cause of avoidable deaths in hospital settings. There is still great uncertainty with relation to the profile of patients who will actually benefit from systemic fibrinolytic treatment, without being exposed to serious risk of bleeding. There are tools that can help to identify patients who will benefit, including risk stratification and estimation of the prognosis of the event, with clinical scores for right ventricular failure, markers of right ventricular dysfunction and dilatation, and thrombotic mass assessment, whether alone or in combination. The only points of consensus with relation to fibrinolytic therapy for treatment of pulmonary thromboembolism are as follows: it should not be routinely indicated, none of the scores or markers alone should be used to justify its use, and patients with hemodynamic instability are the most likely to benefit. Furthermore, each case should be evaluated for risk of bleeding, especially central nervous system bleeding.Keywords: fibrinolytics; pulmonary embolism; hemorrhage. ResumoO tromboembolismo pulmonar permanece como um grande desafio terapêutico para os médicos especialistas, pois, apesar de todo investimento e desenvolvimento em seu diagnóstico, profilaxia e tratamento, essa condição continua sendo a principal causa de morte evitável em ambiente hospitalar. Ainda restam muitas dúvidas em relação a qual perfil de paciente vai se beneficiar de fato da terapia fibrinolítica sistêmica, sem ficar exposto a um grande risco de sangramento. A estratificação de risco e a avaliação do prognóstico do evento, através de escores clínicos de insuficiência ventricular direita, marcadores de dilatação e disfunção do ventrículo direito e avaliação da massa trombótica, associados ou de forma isolada, são ferramentas que podem auxiliar na identificação do paciente que irá se beneficiar dessa terapia. Os únicos consensos em relação à terapia fibrinolítica no tratamento do tromboembolismo pulmonar são: não deve ser indicada de forma rotineira; nenhum dos escores ou marcadores, isoladamente, devem justificar seu uso; e os pacientes com instabilidade hemodinâmica são os mais beneficiados. Além disto, deve-se avaliar cada caso em relação ao risco de sangramento, especialmente no sistema nervoso central.Palavras-chave: fibrinolíticos; embolia pulmonar; hemorragia.

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Section: Patients With Submassive Pte (Moderate Risk)mentioning

confidence: 99%

Terapia fibrinolítica sistêmica no tromboembolismo pulmonar

Ceresetto

Marques

2017

J. vasc. bras.

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“…In one study, the use of femoral vein access was the only variable associated with major bleeding, compared to a brachial access (36). A short 7-10 Fr introducer sheath is usually adequate (9,10,27). Though, using a long sheath placed in the main PA can facilitate exchanges for catheter and thromboembolectomy devices.…”

Section: Access Sitementioning

confidence: 99%

“…The ULTIMA trial showed marked improvement in RV parameters without major complications in submassive PE (9). The Prospective, Single-arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (SEATTLE II) trial, a single arm prospective study of 150 patients, showed a reduction in RVD and improvement in pulmonary hypertension in submassive and massive PE without any intracranial hemorrhage (10). The multicenter Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT) registry evaluated CDI for massive and submassive PE (11).…”

Section: Clinical Evidencementioning

confidence: 99%

Catheter-directed interventions for pulmonary embolism

Zarghouni

Charles

Maldonado

et al. 2016

Cardiovasc. Diagn. Ther.

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Pulmonary embolism (PE), a potentially life-threatening entity, can be treated medically, surgically, and percutaneously. In patients with right ventricular dysfunction (RVD), anticoagulation alone may be insufficient to restore cardiac function. Because of the morbidity and mortality associated with surgical embolectomy, clinical interest in catheter-directed interventions (CDI) has resurged. We describe specific catheter-directed techniques and the evidence supporting percutaneous treatments.

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“…After assessing the risks and benefits of the available options for both the mother and fetus, the team reached a consensus to proceed with CDT using an ultrasound-enhanced EKOS catheter ( Figure 2). The goal was to minimize risks to the mother and fetus and simultaneously optimize RV recovery (7,8).…”

Section: Casementioning

confidence: 99%