• Dvt Risk Score

IntroductionVenous thromboembolic disease (VTE) is estimated to occur in at least 1 to 2 persons per 1000 population annually, manifesting as deep vein thrombosis (DVT), pulmonary embolism (PE) or in combination. 1-3 It is the cause of over 100,000 deaths annually and is the most preventable cause of death in hospitalized patients in the United States. 4 Despite treatment with anticoagulant therapy, a significant proportion of survivors of acute DVT or PE are at risk of suffering from the disabling sequelae such as the post thrombotic syndrome (PTS), recurrent VTE or chronic thromboembolic pulmonary hypertension (CTEPH).

1,5 Given the limitations of medical therapy, promising endovascular treatment modalities have evolved over the past two decades in an effort to mitigate the acute and chronic disability from VTE. 6,7 The purpose of this review is to discuss the rationale and evidence for an endovascular treatment approach for high-risk acute DVT and PE patients.The Rationale for an Interventional Approach to Massive and Submassive PEThe most dreaded acute complication of PE is death; it is estimated that over 100,000 deaths in hospitalized patients in the United States are attributable to acute PE each year.

4 The severity of PE is stratified into massive (PE causing hemodynamic compromise), submassive (PE causing right ventricular dysfunction demonstrable by echocardiography, computed tomography or elevated cardiac biomarkers) and non-massive or low-risk (PE without evidence of RV dysfunction or hemodynamic compromise). The International Cooperative Pulmonary Embolism Registry (ICOPER) demonstrated 90-day mortality rates of 58.3% in patients with massive PE versus 15.1% in sub-massive PE. 20 Several studies demonstrate short-term mortality rates of less than 2% in patients with low-risk PE.

21-23 Features suggestive of adverse prognosis in acute PE are listed in Table 2. Up to 4% of patients who survive will develop CTEPH. 24 Untreated CTEPH carries a poor prognosis, especially if associated with pulmonary hypertension and right ventricular dysfunction. 25 Recurrent DVT as well as a large thromboembolic burden has been observed in the literature to correlate with an increased likelihood of developing CTEPH.

24 While in acute PE, obstructive pathophysiology is almost certainly the cause of right ventricular failure and death, 26 histologic and surgical studies suggest that complex factors involving shear stress, remodeling of the pulmonary vascular bed and microvascular inflammation appears to play a role in the development of CTEPH. 27 In patients with massive PE, systemic thrombolytic therapy has been shown to reduce mortality, 28 decrease the risk of developing CTEPH and improve quality of life. 29,30 A recent meta-analysis suggests that systemic thrombolytic therapy also reduces mortality in patients with submassive PE (OR 0.48; 95% CI 0.25 - 0.92). 31 This, however, appears to be at the expense of significant major bleeding complications (OR 2.91; 95% CI 1.95 - 4.36) including intracranial hemorrhage (OR 3.18; 95% CI 1.25 - 8.11). These bleeding-related adverse events as well as treatment failure seen with systemic thrombolysis have resulted in the exploration of catheter-based thrombus removal as an alternative therapeutic option for these patients. 32,33 In contemporary practice, catheter-based endovascular therapy for acute PE can be considered in patients where there is a clear contraindication to full dose thrombolytic therapy or when risk stratification in a patient with stable hemodynamics indicates an increased likelihood of morbidity and mortality.

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Solid line= patients with right ventricular dysfunction by echocardiography and elevated troponin levels. Dashed line= patients with right ventricular dysfunction or elevated troponin levels. Dotted line= patients without right ventricular dysfunction and normal troponin levels. HR = hazard ratio.Patient Selection and Risk StratificationCareful patient selection should be the foundation upon which an individualized endovascular strategy is adopted in clinical practice. Three key considerations should be factored into the decision to proceed with an endovascular approach: 1) disease severity and acuity; 2) likelihood of a major adverse bleeding event; and 3) patient-specific considerations.Systemic thrombolysis is associated with lower all-cause mortality in patients with massive PE and should be the treatment of choice in this subset of patients. 31,39 Current US and European societal guidelines recommend endovascular treatment strategies in the event of treatment failure in this subset of patients.

32,40,41 A pulmonary embolism response team (PERT) approach, whereby a multi-disciplinary team determines the optimal course of action in critically ill patients with massive PE, 42 should be considered when extracorporeal membrane oxygenation (ECMO) and/or surgical pulmonary embolectomy can be life-saving alternatives. 43,44 In submassive PE, use of systemic thrombolysis is associated with a mortality benefit yet significantly increases the risk of major bleeding, including intracranial hemorrhage. 39,45 For this subset of patients ACCP guidelines currently recommend systemic thrombolytic therapy when cardiopulmonary deterioration is evident yet frank hypotension has not occurred.

The ACC/AHA guidelines suggest that catheter embolectomy can be considered when cardiopulmonary deterioration is evident or in submassive PE when patients have clinical evidence of adverse prognosis. The European Society of Cardiology (ESC) recommends two-step risk stratification, first with a validated clinical prognostic assessment tool (Pulmonary Embolism Severity Index or simplified Pulmonary Embolism Severity Index) followed by imaging and biomarker risk assessment. 46,47 When both clinical and objective risk assessment tools are positive, catheter-directed therapy can be considered if cardiopulmonary deterioration is felt to be imminent. The divergence in recommendations clearly reflects a paucity of large randomized trial data in this area. Existing data demonstrates that ultrasound-assisted catheter directed thrombolysis (UA-CDT) is superior to heparin anticoagulation alone in improving right ventricular dilatation within 24 hours without major bleeding complications or recurrent VTE. 33 In a single-arm multicenter study of 150 patients, UA-CDT reduced the mean pulmonary artery systolic pressures by 30% and decreased the mean RV/LV diameter ratio by 25%. 48 At 90 days there was a statistically significant difference in RV systolic function favoring UA-CDT, while RV/LV ratio a trend toward improvement in the UA-CDT arm, it did not reach statistical significance (p = 0.07).

None of the patients had an intracranial bleed while one patient suffered a major bleeding complication. This approach appears to be promising and perhaps favorable in this subset of patients although definitive safety outcomes and medium to long-term mortality data are not known. Patients with low-risk PE should not be considered for endovascular therapy owing to the low associated morbidity and mortality rates.

The only exception being patients who have a large saddle embolus without any adverse hemodynamics or right ventricular effects. Ongoing safety and efficacy trials assessing optimal dose and duration of therapy are eagerly awaited. 49Bleeding Risk AssessmentAll patients being considered for catheter-based endovascular therapies for either acute PE or LE-DVT should undergo a rigorous assessment of bleeding risk. Active bleeding, recent cerebrovascular or intracranial pathology (cerebrovascular accident, transient ischemic attack, cranial trauma, recent neurosurgery) or absolute contraindications to anticoagulation are absolute contraindications to any type of endovascular treatment strategy involving thrombolytics. Relative contraindications (Table 1), especially if not correctible should be carefully reviewed on an individualized basis.Patient-Specific ConsiderationsPatient preference should be central in determining whether an endovascular treatment approach is appropriate. It is the responsibility of the physician to delineate the risks and benefits outlined above and discuss these in the context of each individual patient's life expectancy and functional status.

This is especially important when presenting endovascular treatment strategies for LE-DVT as they are not performed to prevent death, but with the goal of improving quality of life and function in the long term. 41 Careful consideration must be given to the effect of chronic co-morbidities to the patients' functional status as well as their ability to tolerate the procedure itself.Contemporary Treatment Strategies for Acute PEAnticoagulationAnticoagulation therapy is the primary treatment option for most patients with acute PE. The utilization of factor Xa antagonists and direct thrombin inhibitors, collectively termed Novel Oral Anticoagulants (NOACs) are likely to increase as they become incorporated into societal guidelines as first line therapy. 38 Adoption of these newer agents may mitigate the major limitation of VKA therapy, frequently found in studies of VTE/PE to have sub-therapeutic INRs in a significant number of patients.

50 Low molecular weight heparin is superior to unfractionated heparin in both treatment and thrombo-prophylaxis in cancer patients. 27,51 This is reflected in the recommendations made by the American College of Chest Physicians who recommend the use of low molecular weight heparin on the basis of the strength of evidence available. 38 The importance of prompt initiation of anticoagulation cannot be over emphasized; objective assessment of bleeding risk, set in the context of the risk of choosing not to use anticoagulation, should prevent overly conservative practices founded upon theoretical concerns over bleeding.Inferior Vena Cava FiltersThe role of inferior vena cava filters (IVCF) in the contemporary management of acute VTE has not been truly defined owing to a paucity of high quality evidence. At present the benefit of IVCF use seems to be in reducing the risk of acute PE in patients who have a clear contraindication to anticoagulation in the form of active bleeding. 54,55 In the absence of such a contraindication there appears to be no clear benefit and non-retrieval of IVCF exposes the patient to risk of recurrent VTE, PTS and other mechanical complications such as filter fracture or migration. 56,54,19 Societal guidelines appear to be congruent with this data but importantly differ in their recommendations where high quality evidence is lacking. 32,38,57,58 Notable examples of these disparate recommendations include free floating proximal LE-DVT, acute PE in the presence of a pre-existing IVCF, poor medication compliance and IVCF use as VTE prophylaxis in the setting of immobility, trauma or major surgery.

The need for definitive evidence related to IVCF use in some of these circumstances has long been recognized though randomized control data continues to be lacking. 58Percutaneous Mechanical Thrombectomy (PMT) for Massive and Submassive Acute PESeveral percutaneous approaches have been used alone or in combination in patients with an absolute contraindication to thrombolysis.

These include: 1) thrombus fragmentation with a rotating pigtail catheter; 2) aspiration thrombectomy; 3) rheolytic thrombectomy; and 4) suction embolectomy. Thrombus fragmentation techniques using balloon angioplasty or rotation of pigtail catheters are probably the earliest examples of catheter-based intervention for acute PE. This technique is rarely utilized as a stand-alone procedure and carries a significant risk of distal and proximal embolization. Advanced fragmentation catheters such as the Amplatzer-Helix thrombectomy catheter (EV3, Endovascular, Plymouth, MN) improves upon clot fragmentation through use of an impeller to macerate the thrombus but lacks the capability of aspirating the resultant debris and cannot be advanced over a wire.

Rheolytic thrombectomy catheters (AngioJet, Medrad Interventional, PA) work by creating a vacuum behind an area of high-pressure saline jets at the tip of the catheter. This enables simultaneous thrombus fragmentation and aspiration. Additionally, this device can be used to forcefully infuse ('power-pulse spray') a thrombolytic agent such as r-tPA instead of saline, which is likely to enhance the thrombolytic efficacy. When used in conjunction with thrombolytics, bradycardia, hypoxia and vasospasm has been observed, possibly due to adenosine release as a result of platelet disruption, which has resulted in a FDA black box warning regarding use of the device in the treatment of acute PE.

These side effects can be overcome with aminophylline infusion and with the use of transvenous pacing prior to fragmentation. 81 Caution must be exercised during the placement of all catheters into the pulmonary arterial circulation.

Ensuring proper positioning is vital in order to prevent the risk of catastrophic vessel injury as well as distal embolization of thrombus when using high-pressure injection systems. For this reason, we advocate the use of available computed tomography to help guide the optimal placement of any drug delivery system.

Suction embolectomy devices such as the Greenfield catheter benefit from being large bore catheters capable of achieving thrombus removal without the side effects associated with fragmentation and rheolytic techniques. 82 Despite this, technical difficulties related to catheter size have precluded its widespread adoption.

Emerging devices such as the FlowTriever System (Inari Medical, Irvine, CA) and the Indigo System (Penumbra Inc., Alameda, CA), which are specifically designed for use in patients with an absolute contraindication to thrombolytic therapy, currently remain only in investigational stages. 83The optimal PMT strategy to use in patients with an absolute contraindication to systemic fibrinolysis is best determined on an individualized basis. To gain access to the diseased vasculature, we recommend the following approach recommended by the AHA/ACC guidelines. 32 Obtain access through a 6F femoral venous sheath and advance a 6F angled pigtail catheter into each main pulmonary artery. Disease burden can be visualized at this point by administering low-osmolar or iso-osmolar contrast (30ml over 2 seconds).

Unfractionated heparin should be used to maintain a clotting time 250 seconds. A direct thrombin inhibitor such as Bivalirudin (0.75mg/kg as an intravenous bolus followed by 1.75mg/kg/h) can be used as an alternative if there is a non-bleeding contraindication to heparin use. A 6F guiding catheter is used to reach the thrombus which can then be crossed with a hydrophilic guidewire, over which the PMT devices are advanced.

This approach should be limited to the main and lobar pulmonary artery branches and placement of a temporary transvenous pacer or use of aminophylline should be considered.Ultrasound-Assisted CDT (UA-CDT) for Acute PEFor patients without an absolute contraindication to systemic thrombolysis, UA-CDT can be considered. Low energy ultrasound disaggregates fibrin within acute thrombi, 84 this is exploited by the EKOS device (EkoSonic, Bothell, WA), which combines emission of low energy ultrasound and infusion of a thrombolytic agent via a multi side-hole containing catheter. This strategy has been evaluated in the ULTIMA (Ultrasound-Assisted, Catheter-Directed Thrombolysis for Acute Intermediate-Risk Pulmonary Embolism) trial, 33 which demonstrated superiority to anticoagulation alone in improving hemodynamics without a significant increase in bleeding complications.

Dvt Risk Score

The SEATTLE II (A Prospective, Singe-arm, Multi-center Trial of EkoSonic(R) Endovascular System and Activase for Treatment of Acute Pulmonary Embolism) study, 48 was a single arm multi-center trial of UA-CDT that demonstrated improved right ventricular hemodynamic indices in patients undergoing UA-CDT for both massive and submassive PE.