Akhilesh K. Sista

Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry

BACKGROUND Systemic thrombolysis for acute pulmonary embolism (PE) carries up to a 20% risk of major bleeding, including a 2% to 5% risk of hemorrhagic stroke. We evaluated the safety and effectiveness of catheter-directed therapy (CDT) as an alternative treatment of acute PE. METHODS One hundred one consecutive patients receiving CDT for acute PE were prospectively enrolled in a multicenter registry. Massive PE (n = 28) and submassive PE (n = 73) were treated with immediate catheter-directed mechanical or pharmacomechanical thrombectomy and/or catheter-directed thrombolysis through low-dose hourly drug infusion with tissue plasminogen activator (tPA) or urokinase. Clinical success was defined as meeting all the following criteria: stabilization of hemodynamics; improvement in pulmonary hypertension, right-sided heart strain, or both; and survival to hospital discharge. Primary safety outcomes were major procedure-related complications and major bleeding events. RESULTS Fifty-three men and 48 women (average age, 60 years [range, 22-86 years]; mean BMI, 31.03 ± 7.20 kg/m2) were included in the study. The average thrombolytic doses were 28.0 ± 11 mg tPA (n = 76) and 2,697,101 ± 936,287 International Units for urokinase (n = 23). Clinical success was achieved in 24 of 28 patients with massive PE (85.7%; 95% CI, 67.3%-96.0%) and 71 of 73 patients with submassive PE (97.3%; 95% CI, 90.5%-99.7%). The mean pulmonary artery pressure improved from 51.17 ± 14.06 to 37.23 ± 15.81 mm Hg (n = 92) (P < .0001). Among patients monitored with follow-up echocardiography, 57 of 64 (89.1%; 95% CI, 78.8%-95.5%; P < .0001) showed improvement in right-sided heart strain. There were no major procedure-related complications, major hemorrhages, or hemorrhagic strokes. CONCLUSIONS CDT improves clinical outcomes in patients with acute PE while minimizing the risk of major bleeding. At experienced centers, CDT is a safe and effective treatment of both acute massive and submassive PE. TRIAL REGISTRY ClinicalTrials.gov; No.: NCT01097928; URL: www.clinicaltrials.gov.

Quality improvement guidelines for the treatment of lower-extremity deep vein thrombosis with use of endovascular thrombus removal.

Suresh Vedantham, MD, Patricia E. Thorpe, MD, John F. Cardella, MD, Chair, Clement J. Grassi, MD, Nilesh H. Patel, MD, Hector Ferral, MD, Lawrence V. Hofmann, MD, Bertrand M. Janne d’Othée, MD, Vittorio P. Antonaci, MD, Elias N. Brountzos, MD, Daniel B. Brown, MD, Louis G. Martin, MD, Alan H. Matsumoto, MD, Steven G. Meranze, MD, Donald L. Miller, MD, Steven F. Millward, MD, Robert J. Min, MD, Calvin D. Neithamer Jr., MD, Dheeraj K. Rajan, MD, Kenneth S. Rholl, MD, Marc S. Schwartzberg, MD, Timothy L. Swan, MD, Richard B. Towbin, MD, Bret N. Wiechmann, MD, and David Sacks, MD, for the CIRSE and SIR Standards of Practice Committees

Persistent right ventricular dysfunction, functional capacity limitation, exercise intolerance, and quality of life impairment following pulmonary embolism: Systematic review with meta-analysis

Long-term right ventricular (RV) function, functional capacity, exercise capacity, and quality of life following pulmonary embolism (PE), and the impact of thrombolysis, are unclear. A systematic review of studies that evaluated these outcomes with ⩾ 3-month mean follow-up after PE diagnosis was performed. For each outcome, random effects meta-analyses were performed. Twenty-six studies (3671 patients) with 18-month median follow-up were included. The pooled prevalence of RV dysfunction was 18.1%. Patients treated with thrombolysis had a lower, but not statistically significant, risk of RV dysfunction versus those treated with anticoagulation (odds ratio: 0.51, 95% CI: 0.24 to 1.13, p=0.10). Pooled prevalence of at least mild functional impairment (NYHA II–IV) was 33.2%, and at least moderate functional impairment (NYHA III–IV) was 11.3%. Patients treated with thrombolysis had a lower, but not statistically significant, risk of at least moderate functional impairment versus those treated with anticoagulation (odds ratio: 0.48, 95% CI: 0.15 to 1.49, p=0.20). Pooled 6-minute walk distance was 415 m (95% CI: 372 to 458 m), SF-36 Physical Component Score was 44.8 (95% CI: 43 to 46), and Pulmonary Embolism Quality of Life (QoL) Questionnaire total score was 9.1. Main limitations included heterogeneity among studies for many outcomes, variation in the completeness of data reported, and inclusion of data from non-randomized, non-controlled, and retrospective studies. Persistent RV dysfunction, impaired functional status, diminished exercise capacity, and reduced QoL are common in PE survivors. The effect of thrombolysis on RV function and functional status remains unclear.

Guidance for the use of thrombolytic therapy for the treatment of venous thromboembolism

Patients with venous thromboembolism (VTE) are prone to the development of both short-term and long-term complications that can substantially affect their functional capacity and quality of life. Patients with deep vein thrombosis (DVT) often develop recurrent VTE or the post-thrombotic syndrome, whereas patients with pulmonary embolism (PE) can develop long-term symptoms and functional limitations along a broad spectrum extending to full-blown chronic thromboembolic pulmonary hypertension. Clinicians who care for patients showing severe clinical manifestations of DVT and PE are often faced with challenging decisions concerning whether and how to escalate to more aggressive treatments such as those involving the use of thrombolytic drugs. The purpose of this chapter is to provide guidance on how best to individualize care to these patients.

Characterization of In Vivo Ablation Zones Following Percutaneous Microwave Ablation of the Liver with Two Commercially Available Devices: Are Manufacturer Published Reference Values Useful?

PURPOSE To analyze in vivo ablation properties of microwave ablation antennae in tumor-bearing human livers by performing retrospective analysis of ablation zones following treatment with two microwave ablation systems. MATERIALS AND METHODS Percutaneous microwave ablations performed in the liver between February 2011 and February 2013 with use of the AMICA and Certus PR ablation antennae were included. Immediate postablation computed tomography images were evaluated retrospectively for ablation length, diameter, and volume. Ablation length, diameter, and volume indices were calculated and compared between in vivo results and references provided from each device manufacturer. The two microwave antenna models were then also compared versus each other. RESULTS Twenty-five ablations were performed in 20 patients with the AMICA antenna, and 11 ablations were performed in eight patients with the Certus PR antenna. The AMICA and Certus PR antennae showed significant differences in ablation length (P = .013 and P = .009), diameter (P = .001 and P = .009), and volume (P = .003 and P = .009). The AMICA ablation indices were significantly higher than the Certus PR ablation indices in length (P = .026) and volume (P = .002), but there was no significant difference in ablation diameter indices (P = .110). CONCLUSIONS In vivo ablation indices of human tumors are significantly smaller than reference ex vivo ablation indices, and there are significant differences in ablation indices and sphericity between devices.

Endovascular therapy for advanced post-thrombotic syndrome: Proceedings from a multidisciplinary consensus panel.

Patients with advanced post-thrombotic syndrome (PTS) and chronic iliac vein obstruction suffer major physical limitations and impairment of health-related quality of life. Currently there is a lack of evidence-based treatment options for these patients. Early studies suggest that imaging-guided, catheter-based endovascular therapy can eliminate iliac vein obstruction and saphenous venous valvular reflux, resulting in reduced PTS severity; however, these observations have not been rigorously validated. A multidisciplinary expert panel meeting was convened to plan a multicenter randomized controlled clinical trial to evaluate endovascular therapy for the treatment of advanced PTS. This article summarizes the findings of the panel, and is expected to assist in developing a National Institutes of Health-sponsored clinical trial and other studies to improve the care of patients with advanced PTS.

Four key questions surrounding thrombolytic therapy for submassive pulmonary embolism

Submassive pulmonary embolism (PE) remains a vexing entity, and the appropriate use of thrombolytic therapy for this subgroup continues to be actively debated. Catheter-directed thrombolysis has shown efficacy for submassive PE and is gaining momentum because of theoretically improved safety. This review poses and responds to four questions that explore the complex issues surrounding optimal therapy of submassive PE.

Endovascular Interventions for Acute and Chronic Lower Extremity Deep Venous Disease: State of the Art

The societal and individual burden caused by acute and chronic lower extremity venous disease is considerable. In the past several decades, minimally invasive endovascular interventions have been developed to reduce thrombus burden in the setting of acute deep venous thrombosis to prevent both short- and long-term morbidity and to recanalize chronically occluded or stenosed postthrombotic or nonthrombotic veins in symptomatic patients. This state-of-the-art review provides an overview of the techniques and challenges, rationale, patient selection criteria, complications, postinterventional care, and outcomes data for endovascular intervention in the setting of acute and chronic lower extremity deep venous disease. Online supplemental material is available for this article.

A pulmonary embolism response team’s initial 20 month experience treating 87 patients with submassive and massive pulmonary embolism:

Pulmonary Embolism Response Teams (PERTs) have emerged to provide rapid multidisciplinary assessment and treatment of PE patients. However, descriptive institutional experience and preliminary outcomes data from such teams are sparse. PERT activations were identified through a retrospective review. Only confirmed submassive or massive PEs were included in the data analysis. In addition to baseline variables, the therapeutic intervention, length of stay (LOS), in-hospital mortality, and bleeding rate/severity were recorded. A total of 124 PERT activations occurred over 20 months: 43 in the first 10 months and 81 in the next 10. A total of 87 submassive (90.8%) and massive (9.2%) PE patients were included. The median age was 65 (51–75 IQR) years. Catheter-directed thrombolysis (CDT) was administered to 25 patients, systemic thrombolysis (ST) to six, and anticoagulation alone (AC) to 54. The median ICU stay and overall LOS were 6 (3–10 IQR) and 7 (4–14 IQR) days, respectively, with no association with any variables except a brain natriuretic peptide (BNP) >100 pg/mL (p=0.008 ICU LOS; p=0.047 overall LOS). Twelve patients (13.7%) died in the hospital, nine of whom had metastatic or brain cancer, with a median overall LOS of 13 (11–17 IQR) days. There were five major bleeds: one in the CDT group, one in the ST group, and three in the AC group. Overall, (1) PERT activations increased after the first 10 months; (2) BNP >100 pg/mL was associated with a longer LOS; (3) rates of mortality and bleeding did not correlate with treatment; and (4) the majority of in-hospital deaths occurred in patients with advanced cancer.

Late outcomes of pulmonary embolism: The post-PE syndrome

The post-Pulmonary Embolism (post-PE) syndrome is being increasingly recognized as a long-term consequence of PE. Its most severe manifestation, chronic thromboembolic pulmonary hypertension (CTEPH), affects a small proportion of PE survivors. However, many more with less severe post-PE syndrome have reduced quality of life and functional capacity. The pathophysiology is incompletely understood, but involves unresolved pulmonary artery thrombi, right ventricular damage, and abnormal gas exchange. Treatment has only been established for CTEPH, and further studies are required to determine how less severe forms of the post-PE syndrome should be treated and if preventive strategies can reduce its incidence.