TY - JOUR
AU1 - Kochar, Ajar
AU2 - Bergmark, Brian A
AB - Abstract Pulmonary embolism (PE) is common, life-threatening, and often recurrent among survivors. The clinical manifestations of PE range from incidental detection to sudden death, with approximately one-third of PE deaths occurring suddenly. State-of-the-art management of acute PE relies on early detection, risk stratification based on clinical, imaging, and biomarker criteria, and multidisciplinary decision-making. The primary goal of catheter-directed interventions for acute PE is to interrupt the cycle of right ventricular failure, hypoperfusion, and oxygen supply/demand imbalance by increasing the cross-sectional area of the patent pulmonary vasculature, thereby lowering resistance and alleviating V/Q mismatch. Innovations in percutaneous interventions have led to several approaches described in this review: rheolytic thrombectomy, catheter-directed thrombolysis, and aspiration or mechanical thrombectomy. The central challenge moving forward will be integrating growing clinical trial evidence into multidisciplinary, individualized care pathways meeting the diverse clinical needs of patients presenting with acute PE. Pulmonary embolism, Catheter-directed, Intervention, Embolectomy Introduction Pulmonary embolism (PE) is common, life-threatening, and often recurrent among survivors.1,2 Venous thrombo-embolism (VTE), encompassing both deep vein thrombosis and PE, accounts for a substantial portion of acute cardiovascular syndromes, including >1 000 000 incident cases in the USA annually1 and resulting in an estimated €8.5 billion in healthcare expenditures in the European Union every year.2,3 The annual recorded incidence of VTE was increasing even before the COVID-19 pandemic, likely due in part to ageing populations and greater detection,1 and the global spread of this virus in which VTE is seen in 20–30% of hospitalized patients1,4 has now drastically shaped the landscape of VTE management in the current era.5 The clinical manifestations of PE range from incidental detection to sudden death, with approximately one-third of PE deaths occurring suddenly. Among patients who survive a first PE, the long-term consequences are considerable, with more than half of survivors reporting dyspnoea or diminished functional status beyond 6 months after the index event,6 and a smaller proportion demonstrating persistently abnormal right ventricular (RV) function or pulmonary artery pressures. The most severe long-term consequence, chronic thrombo-embolic pulmonary hypertension (CTEPH), occurs in a small minority of cases, but it is debilitating and challenging to treat.6 Given the potentially severe consequences of PE in the acute and chronic phases, there is substantial interest in the treatment of incident PE. However, the breadth of available therapies, including medical management, surgical embolectomy, and percutaneous interventions, paired with a still-nascent evidence base for these approaches, has led to significant variation in the treatment of acute PE and difficulty arriving at consensus treatment pathways.2,7 State-of-the-art management of acute PE relies on early detection, risk stratification based on clinical, imaging, and biomarker criteria,2 and multidisciplinary decision-making taking into account local expertise.2,7 We are currently in a period of rapid innovation and evidence generation in percutaneous therapies for PE. New devices have recently entered clinical practice, still others are in development, and the first large, randomized trials studying percutaneous approaches in acute PE are underway (NCT04790370 and NCT05111613). The purpose of this review is to provide an up-to-date description of catheter-directed interventions for acute PE and the clinical evidence for their use. Percutaneous interventions for pulmonary embolism An abrupt increase in RV afterload and impaired gas exchange underlie the life-threatening positive feedback cycle of RV failure, hypoperfusion, and oxygen supply/demand mismatch seen with acute PE (Figure 1).2 The primary goal of catheter-directed interventions for acute PE is to interrupt this cycle by increasing the cross-sectional area of the patent pulmonary vasculature, thereby lowering resistance and alleviating V/Q mismatch. Figure 1 Open in new tabDownload slide Reproduced with permission from Konstantinides et al.2 Key factors contributing to haemodynamic collapse and death in acute pulmonary embolism (modified from Konstantinides et al.2 with permission). A-V, arterio-venous; BP, blood pressure; CO, cardiac output; LV, left ventricular; O2, oxygen; RV, right ventricular; TV, tricuspid valve. aThe exact sequence of events following the increase in RV afterload is not fully understood. While transvenous aspiration of acute PE has been considered since the 1960s with the development of the Greenfield catheter, mechanical disruption of central PE with a general use catheter such as a pigtail catheter was historically the primary method of attempted percutaneous revascularization.8 This approach was often taken as a last resort, and while mechanical disruption achieved fragmentation of the most central thrombus in some cases, there was presumably embolization of the liberated thrombus and likely no major change in patent cross-sectional area. Innovations in percutaneous interventions since that time have led to several approaches, which will be described here: rheolytic thrombectomy, catheter-directed thrombolysis (CDT), and aspiration or mechanical thrombectomy. Rheolytic thrombectomy Rheolysis refers to flow-mediated lysis and is available with the AngioJet catheter (Boston Scientific, Minneapolis, MN, USA). The catheter emits a high-velocity stream of saline or thrombolytic, which is intended to mechanically fragment the thrombus while, according to the Bernoulli principle, also creating a low-pressure zone near the catheter tip to facilitate thrombectomy of disrupted material.8,9 The clinical evidence base for use of the AngioJet catheter in acute PE is limited to small, non-randomized observations.9,10 Further, concerning rates of bradycardia, hypotension, and hypoxaemia have been observed,10 presumably related to the release of neurohormonal agents such as adenosine, leading to a black box warning from the US Food and Drug Administration against the use of AngioJet in acute PE.8 Catheter-directed thrombolysis A second approach to percutaneous treatment of PE utilizes indwelling catheters to deliver a thrombolytic agent locally. These devices take two forms: standard CDT and ultrasound-assisted CDT (UA-CDT). The rationale for locally delivered thrombolysis is based on the observation that systemically delivered thrombolytic causes major bleeding, including intracranial haemorrhage in ∼2% of appropriately selected patients,11 and that systemic thrombolytic will preferentially circulate away from the site of pulmonary artery occlusion. The use of CDT allows for lower rates of infusion, typically 1–2 mg/h, and administration at the site of occlusion. Standard CDT involves the placement of dedicated infusion catheters into the pulmonary artery, either unilaterally or bilaterally depending on the patient’s thrombus distribution. Two commonly used devices are the Cragg-McNamara catheter (Medtronic, Minneapolis, MN, USA) and the Uni-Fuse catheter (Angiodynamics, Latham, NY, USA). These catheters are 4–5 Fr and have infusion lengths up to 50 cm, though shorter infusion lengths are typically used in the pulmonary vasculature. In a multicentre observational cohort of 101 patients with massive or submassive PE undergoing CDT (N = 65) or UA-CDT (N = 36), the mean dose of tissue plasminogen activator (tPA) was 28.0 mg.12 Clinical success, defined as haemodynamic stabilization, decreases in pulmonary artery pressures or degree of RV strain, and survival to hospital discharge, was observed in 86% of patients with massive PE and 97% of patients with submassive PE.12 Minor bleeding occurred in 13% of patients and there were no cases of intracranial haemorrhage or major bleeding. There was no significant difference in the observed change in pulmonary artery pressures between patients treated with CDT vs. those treated with UA-CDT. In a 52-patient randomized trial of systemic vs. locally administered thrombolytic, there was a higher rate of clinical success (96%) with local thrombolytic compared with systemic thrombolytic (71%), including lower rates of mortality and major bleeding.13 A novel CDT catheter, the Bashir endovascular catheter, comprises expandable and collapsible infusion limbs, which form a basket when opened. The expanded basket is intended to create a conduit for blood flow while also enhancing radial thrombolytic dispersion.14 The catheter can be placed via a 7 or 8 Fr sheath. First-in-human experience was described in nine patients with intermediate-risk PE and RV/left ventricular (LV) ratio ≥0.9.14 There was a mean 37% reduction in RV/LV ratio at 48 h. Combining chemical and mechanical thrombolytic mechanisms is the basis UA-CDT using the EkoSonic (EKOS) catheter (Boston Scientific, Marlborough, MA, USA) (Figure 2). The system is a 5.4 Fr dual-lumen catheter, with one lumen used for thrombolytic infusion and the other housing a high-frequency (2.2 MHz), low-power (0.5 W/element) ultrasound emitter. This device is based on the premise that locally delivered ultrasound energy may disrupt fibrin strands within the thrombus,15 assisting in mechanical disaggregation of the clot and also allowing for the thrombolytic agent to access its site of biological action on the fibrin protein.16 Figure 2 Open in new tabDownload slide Bilateral EkoSonic catheters in place via the right internal jugular vein in a patient with intermediate-risk pulmonary embolism. The asterisks indicate examples of the radio-opaque ultrasound emitters. The channels for thrombolytic administration are not fluoroscopically visible but correspond with the ultrasound transmitters. The EKOS catheter has been investigated in several prospective studies. The ULTIMA trial was a randomized comparison of UA-CDT vs. systemic unfractionated heparin in 59 patients with acute PE and RV/LV ratio ≥1.0.17 The primary outcome, the difference in RV/LV ratio from baseline to 24 h, was significantly greater in the UA-CDT arm (mean decrease 0.30 ± 0.20 vs. 0.03 ± 0.16; P < 0.001) and there were no major bleeding events in either arm. SEATTLE II was a single arm, multicentre, prospective observation of UA-CDT among 150 patients with acute massive or submassive PE, proximal thrombus, and RV/LV ratio ≥0.9.18 A total of 24 mg of tPA were administered over 12–24 h and the primary efficacy endpoint was the change in RV/LV ratio within 48 h. The mean decrease in RV/LV ratio was 0.42 (P < 0.0001) and the mean pulmonary artery systolic pressure decreased significantly from procedure start to procedure end, but with no further decrement at 48 h. The purpose of the OPTALYSE PE trial was to optimize the thrombolytic dose and infusion rate.19 Patients with intermediate-risk PE (N = 101) were randomized to one of four UA-CDT regimens with tPA doses ranging from 4 to 12 mg/lung and infusion durations ranging from 2 to 6 h. Improvements in RV/LV ratio at 48 h were seen in all treatment arms and four major bleeding events occurred, including two intracranial haemorrhages. Numerous additional single-arm observations of UA-CDT use in acute PE have been published or are ongoing.20,21 Randomized data are sparse, however, though the SUNSET sPE trial enrolled 81 patients with submassive PE and randomized them to UA-CDT or standard CDT.22 At 48 h, there were similar reductions in thrombus score as measured by computed tomography between the two treatment arms. This clinical evidence base for UA-CDT provides a helpful description of procedural success and complication rates as well observations of changes in surrogate markers of PE severity and recovery over short time periods. However, the great majority of patients studied to date has not been part of an active comparison and thus questions remain about how these findings would compare to medical therapy, surgical embolectomy, or alternate catheter-based therapies, as well as how different strategies might impact short- and long-term clinical outcomes. The HI-PEITHO randomized trial (NCT04790370), which is underway, will compare clinical outcomes following systemic anticoagulation vs. UA-CDT in patients with intermediate-risk PE. The primary endpoint is PE mortality, PE recurrence, or cardiorespiratory decompensation within 7 days. Anticipated enrolment is 406 subjects and up to 12-month follow-up is planned. Thrombectomy Percutaneous thrombectomy offers the theoretical advantage of immediate thrombus removal and restoration of pulmonary blood flow. The two approaches to thrombectomy currently available are suction thrombectomy, in which the catheter is attached to a negative pressure aspiration source, and mechanical (manual) thrombectomy. The currently available suction thrombectomy devices are the Indigo system (Penumbra, Alameda, CA, USA), the Aspirex catheter (Straub Medical, Wangs, Switzerland), and the AngioVac system (Angiodynamics, Latham, NY, USA). The Indigo system has several catheter sizes available up to 12 Fr, and the catheter is attached to an aspiration source that produces suction up to −29 in Hg. The Aspirex catheter is an 11 Fr device, which contains a rotating coil intended to mechanically disrupt the aspirated clot. The AngioVac system involves a veno-veno bypass system with a 22 Fr inflow cannula, the circuit motor with an embedded filter, and a 16–20 Fr outflow cannula for reinfusion of filtered blood. Sparse clinical evidence exists for these devices. The Indigo system was evaluated in the EXTRACT PE single-arm study, which enrolled 119 patients with acute PE and RV/LV ratio >0.9.23 The mean decrease in RV/LV ratio at 48 h was 0.43 (P < 0.0001) and the rates of procedural complications were low. Descriptions of the use of the Aspirex catheter and Angiovasc system are largely limited to case series.24,25 Mechanical thrombectomy with the FlowTriever catheter (Inari Medical, Irvine, CA, USA) is the most recently developed approach in this space (Figure 3). The FlowTriever system consists of a large bore catheter (up to 24 Fr) and the primary mechanism of action is the manual aspiration of thrombus. Nitinol discs can additionally be deployed into the thrombus to mechanically disrupt the PE and facilitate retrieval. Aspirated blood can be filtered through the FlowSaver device and returned to the patient. Figure 3 Open in new tabDownload slide Mechanical thrombectomy performed in a patient with haemodynamically unstable saddle pulmonary embolism. Axial computed tomography scan in shown in (A) with saddle pulmonary embolism (arrow); 24 Fr T24 FlowTriever catheter (arrow) delivered over an Amplatz wire (asterisk) via the right common femoral vein is shown in (B); a removed thrombus from the right and the left pulmonary arteries is shown in (C). Prospective clinical evidence for the FlowTriever system to-date consists of the FLARE study26 and the interim findings of the FLASH study.27 FLARE was a single-arm assessment of FlowTriever among 106 patients with acute intermediate-risk PE and RV/LV ratio ≥0.9. The mean reduction in RV/LV ratio from baseline to 48 h was 0.38 (P < 0.0001) and there was one major bleeding event.26 The FLASH registry is intended to enrol an all-comers population of patients with acute PE and RV/LV ratio ≥0.9 undergoing mechanical thrombectomy. The final anticipated sample size is 1300 patients, though interim results from the first 250 patients have been reported, showing a mean reduction in mean pulmonary artery pressure of 7.1 mmHg and no device-related injuries, episodes of clinical deterioration, or deaths within 48 h.27 Ongoing prospective studies of the FlowTriever device include the single-arm FLAME registry (NCT04795167), which aims to enrol 250 patients with massive PE, and the PEERLESS randomized controlled trial comparing FlowTriever to CDT (NCT05111613) in patients with acute intermediate-risk PE. The PEERLESS trial represents the first randomized comparison of interventional therapies for acute PE powered to detect a difference in clinical outcomes. Clot-in-transit Clot-in-transit, which refers to mobile thrombus identified in the inferior vena cava, superior vena cava, right atrium, or right ventricle, is relatively uncommon, occurring in 3–4% of PE patients.28 However, clot-in-transit may be seen in up to 18% of haemodynamically unstable PE patients, and is associated with a five-fold greater risk of mortality.28 Additionally, in patients with patent foramen ovale or septal defect, a clot in transit can result in stroke or other arterial embolic events. Various echocardiography modalities including transthoracic, trans-oesophageal, or intra-cardiac echocardiography can be employed to augment the success of percutaneous interventions in this scenario. There is no consensus on the optimal management strategy for clot-in-transit. As for any PE, therapy options include systemic anticoagulation, pharmacological thrombolysis, catheter-based interventions, and surgical embolectomy. In a pooled retrospective analysis, both systemic thrombolytic therapy and surgical embolectomy were associated with lower mortality as compared with anticoagulation alone after multivariable analysis.29 As opposed to surgical embolectomy, catheter-based interventions provide a less invasive approach and may be more rapid, though the at least theoretical possibility exists of disrupting proximal thrombus and inducing further distal embolization. Clinical data regarding the use of percutaneous therapies for clot-in-transit are sparse, though a report on the use of FlowTriever in three cases of clot-in-transit30 supported the USFDA 510(k) approval of this device for right atrial clot-in-transit. Mechanical circulatory support Massive PE resulting in acute RV dysfunction can deteriorate into cardiogenic shock and cardiac arrest. The thin-walled RV is particularly vulnerable to acute increases in afterload and most often incapable of mustering a mean pulmonary pressure >40 mmHg.31 The first line approach to PE-related haemodynamic dysfunction is a modest fluid challenge or the use of vaso-active medications such as norepinephrine, levosimendan, or dobutamine.2 Failing these initial pharmacological strategies, PE-related cardiogenic shock may be stabilized with mechanical circulatory support (MCS) devices. Importantly, there are no randomized data supporting the use of MCS in the PE setting. Because haemodynamic collapse and hypoxaemia often co-exist in the setting of massive PE, veno-arterial (VA)–extracorporeal membrane oxygenation (ECMO) is commonly considered in PE as it provides both haemodynamic and respiratory support. A French analysis of 52 patients treated with VA-ECMO for PE treated with or without systemic thrombolysis found a mortality rate of 77%. However, the mortality rates were significantly lower at 29% when patients were treated with VA-ECMO and surgical embolectomy.32 These data suggest the hypothesis that the combination of active thrombus removal with supportive MCS may lead to improved outcomes for patients with high-risk PE. In a US-based single-centre analysis of 136 PE patients, ECMO was the primary therapy in 15% of patients. The median duration of ECMO use was 5 days and surgical embolectomy was required in 16% of patients, while the rest were managed with anticoagulation.33 VA-ECMO use is associated with a high frequency of complications such as stroke, vascular injury, limb ischaemia, and bleeding.34 Bleeding complications are particularly common, seen in as high as 20–50% of patients, and the risk of bleeding is amplified with systemic thrombolytic use.32 Right ventricular-specific MCS may also be considered. The Impella RP (Abiomed, Danvers, MA, USA) was the first percutaneous RV support device approved by the USFDA. It is a percutaneous axial pump that propels blood from the inferior vena cava into the pulmonary artery at a rate >4 L/min.31 The Impella RP must be placed via the femoral vein and hence limits ambulation for patients treated with this modality. There are limited data of Impella RP use in unstable PE patients, but case reports and small series suggest its feasibility and promise.35 Similarly, the TandemHeart Protek Duo (LiveNova, London, UK) cannula can provide right-sided mechanical support. The Protek Duo can be either 29 or 31 Fr, with an inflow opening usually positioned across the superior vena cava and into the right atrium and outflow placed into the pulmonary artery. A centrifugal pump can generate flow > L/min and an oxygenator can be spliced into the system. As with the Impella RP, there are minimal data demonstrating the safety or efficacy of the Protek Duo in high-risk PE.9 Looking forward Catheter-directed therapies for PE are in a dynamic phase of rapid evolution. Several existing technologies are in increasingly widespread use and novel devices are in development. At the same time, the clinical evidence base to guide therapeutic selection is growing. Looking forward, the central question in this field is how best to individualize treatment pathways given the broad array of therapeutic options available and the diverse clinical circumstances encountered in the management of acute PE. Evidence-based treatment selection will require randomized trials powered for clinical outcomes, and the HI-PEITHO and PEERLESS studies mark an important first step in this regard. Nonetheless, if one considers the range of possible patient presentations from low risk to massive PE and the divergent treatment modalities available from anticoagulation alone to systemic thrombolysis to catheter-directed therapies to surgical embolectomy, it is clear that there will never be a randomized comparison of each treatment modality in each disease state. As such, at least in the near term, a small number of well-conducted trials will likely serve as guideposts, leaving clinicians to extrapolate to the broad clinical circumstances encountered in real-world practice, taking into account local availability and expertise. Of additional interest moving forward is understanding whether different catheter-directed therapies may yield clinical benefit when used in conjunction, for example, pairing mechanical thrombectomy with CDT. While this is being done anecdotally in practice, there is limited published literature on combined catheter-directed interventions, and the report in this issue of the journal by the author is an early description of what will likely be a growing area of inquiry. Similarly, defining which patients are most likely to benefit from MCS, optimizing the timing of MCS initiation, and refining technical best practices for performing catheter-directed interventions with MCS in place are all priorities moving forward. Finally, while studies in acute PE understandably tend to focus on short-term surrogate endpoints or clinical outcomes, much of the clinical burden for PE survivors is borne in the chronic phase. Whether treatment of acute PE with catheter-directed therapies can impact the likelihood of future CTEPH or functional impairment is difficult to study but is a critically important question. In conclusion, acute PE is a common, life-threatening problem for which several percutaneous treatment options exist. Catheter-directed intervention for PE is a rapidly growing field with several novel devices in development, and the clinical evidence base is evolving with two large randomized trials underway. The central challenge moving forward will be integrating the growing clinical evidence into multidisciplinary, individualized care pathways meeting the diverse clinical needs of patients presenting with acute PE. Conflict of interest: A.K. has no pertinent disclosures. B.A.B. received grant support through Brigham and Women’s Hospital: Pfizer, Ionis, AstraZeneca, and Abbott Vascular; consulting/personal fees: Abiomed, SpectraWAVE, Endovascular Engineering, CSI, Philips, Abbott Vascular, Servier, Daiichi-Sankyo, Janssen, and Quark. B.A.B. is a member of the TIMI Study Group, which has received institutional grant support through the Brigham and Women’s Hospital from: Abbott, Amgen, Anthos Therapeutics, AstraZeneca, Bayer HealthCare Pharmaceuticals, Inc., Daiichi-Sankyo, Eisai, Intarcia, MedImmune, Merck, Novartis, Pfizer, Quark Pharmaceuticals, Regeneron Pharmaceuticals, Inc., Roche, Siemens Healthcare Diagnostics, Inc., The Medicines Company, and Zora Biosciences. Data availability No new data were generated or analyzed in support of this manuscript. We have summarized previously published work that are publically available for further evaluation. 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TI - Catheter-directed interventions for pulmonary embolism
JF - European Heart Journal. Acute Cardiovascular Care
DO - 10.1093/ehjacc/zuac089
DA - 2022-07-29
UR - https://www.deepdyve.com/lp/oxford-university-press/catheter-directed-interventions-for-pulmonary-embolism-ONXAt40Xch
SP - 1
EP - 1
VL - Advance Article
IS - 
DP - DeepDyve
ER -