Predictors of failure and complications of catheter-directed interventions for pulmonary embolism.

Catheter-directed interventions (CDIs) are increasingly performed for acute pulmonary embolism (PE) as they are presumed to provide similar therapeutic benefits to systemic thrombolysis while decreasing the dose of thrombolytic required and the associated risks. This study aimed to identify factors associated with CDI failure and to describe anticipated complications. Consecutive patients who underwent CDI for massive or submassive PE between 2009 and 2015 were identified; outcomes and complications were retrospectively collected. CDI clinical failure was defined as major bleeding, perioperative stroke or other major adverse procedure-related event, decompensation for submassive or persistent shock for massive PE, need for surgical thromboembolectomy, or in-hospital death. Univariate analysis was used to study the factors associated with CDI failure. There were 102 patients who received a CDI during the study period (36 standard catheter thrombolysis, 60 ultrasound assisted, 6 other; age, 59.2 ± 15.9 years; male, 50 [49.0%]; massive PE, 14 [13.7%]). Five patients (4.9%) had a major contraindication and 15 patients (14.7%) had a minor contraindication to systemic thrombolysis. The mean alteplase dose was 28.2 ± 18.8 mg (range, 0-123 mg; three patients had already received systemic lysis). CDI failure occurred in 15 patients (14.7%; 7 in massive PE, 8 in submassive PE). Of these patients, seven had major bleeding events, whereas eight patients decompensated. Ten (9.8%) patients had minor bleeding events (four access related). Factors associated with CDI failure and major bleeding included massive PE, age ≥70 years, and major contraindication to thrombolytics. Both failures and bleeding events were independent of lysis dose and CDI technique. CDIs for acute PE are not risk-free procedures, and their use should be individualized on the basis of a risk-benefit ratio. Particularly for patients with major contraindications to systemic thrombolytics, CDIs should be used selectively. Lytic dose, within the low-volume range administered in CDI, and type of CDI seem to have no impact on adverse events.

Avgerinos ED ，Abou Ali AN ，Liang NL ，Genovese E ，Singh MJ ，Makaroun MS ，Chaer RA ... -  《-》

Institutional trends over a decade in catheter-directed interventions for pulmonary embolism.

Catheter-directed interventions (CDIs) are commonly performed for acute pulmonary embolism (PE). The evolving catheter types and treatment algorithms impact the use and outcomes of these interventions. This study aimed to investigate the changes in CDI practice and their impact on outcomes. Patients who underwent CDIs for PE between 2010 and 2019 at a single institution were identified from a prospectively maintained database. A PE team was launched in 2012, and in 2014 was established as an official Pulmonary Embolism Response Team. CDI annual use trends and clinical failures were recorded. Clinical success was defined as physiologic improvement in the absence of major bleeding, perioperative stroke or other procedure-related adverse event, decompensation for submassive or persistent shock for massive PE, the need for surgical thromboembolectomy, or death. Major bleeding was defined as requiring a blood transfusion, a surgical intervention, or suffering from an intracranial hemorrhage. There were 372 patients who underwent a CDI for acute PE during the study period with a mean age of 58.9 ± 15.4 years; there were males 187 (50.3%) and 340 patients has a submassive PE (91.4%). CDI showed a steep increase in the early Pulmonary Embolism Response Team years, peaking in 2016 with a subsequent decrease. Ultrasound-assisted thrombolysis was the predominant CDI technique peaking at 84% of all CDI in 2014. Suction thrombectomy use peaked at 15.2% of CDI in 2019. The mean alteplase dose with catheter thrombolysis techniques decreased from 26.8 ± 12.5 mg in 2013 to 13.9 ± 7.5 mg in 2019 (P < .001). The mean lysis time decreased from 17.2 ± 8.3 hours in 2013 to 11.3 ± 8.2 hours in 2019 (P < .001). Clinical success for the massive and the submassive PE cohorts was 58.1% and 91.2%, respectively; the major bleed rates were 25.0% and 5.3%. There were two major clinical success peaks, one in 2015 mirroring our technical learning curve and one in 2019 mirroring our patient selection learning curve. The clinical success decrease in 2018 was primarily derived from blood transfusions owing to acute blood loss during suction thrombectomy. CDIs for acute PE have rapidly evolved with high success rates. Multidisciplinary approaches among centers with appropriate expertise are advisable for the safe and successful implementation of catheter interventions.

Abou Ali AN ，Cherfan P ，Zaghloul MS ，Sridharan N ，Lebron BR ，Toma C ，Chaer RA ，Avgerinos ED ... -  《-》

Catheter-directed interventions compared with systemic thrombolysis achieve improved ventricular function recovery at a potentially lower complication rate for acute pulmonary embolism.

Catheter-directed interventions (CDIs) are increasingly performed for acute pulmonary embolism (PE) as they are presumed to provide similar therapeutic benefits to systemic thrombolysis (ST) while decreasing the associated complications. The purpose of this study was to compare outcomes between CDI and ST. Consecutive patients who underwent CDIs or ST for massive or submassive PE between 2006 and 2016 were identified. Clinical and echocardiographic parameters at baseline and after treatment were recorded. Clinical success was defined as decompensation resolution (or prevention) without major bleeding, stroke, other major treatment-related event, or in-hospital death. The χ2 test and t-test were used for between-groups comparisons. There were 213 patients who received CDIs (standard catheter thrombolysis in 56, ultrasound-assisted thrombolysis in 146, suction thrombectomies in 10, and pharmacomechanical thrombolysis in 1) and 104 patients who received ST (94 high dose [100 mg], 10 low dose [50 mg]). At baseline, CDI and ST groups had comparable echocardiographic parameters, demographics, and comorbidities, except for PE type (massive PE, 8.5% for CDIs vs 69.2% for ST; P < .001), age (60.2 ± 14.9 years for CDIs vs 55.9 ± 17.3 years for ST; P = .023), and renal function (glomerular filtration rate, 78.1 ± 33.7 mL/min/1.73 m2 for CDIs vs 64.1 ± 35.2 mL/min/1.73 m2 for ST; P = .001). Without stratifying per PE type, CDIs had a higher clinical success rate (87.8% vs 66.3%; P < .001) and a lower rate of major bleed (8.0% vs 19.2%; P = .003), stroke (1.4% vs 4.8%; P = .120), and death (1.4% vs 13.5%; P < .001). On stratifying by PE type, there was no difference in clinical success between groups. The mean reduction in right ventricular/left ventricular diameter ratio between baseline and the first post-treatment echocardiographic examination (within 30 days) was significantly higher for CDI (0.27 ± 0.20 vs 0.18 ± 0.15; P = .037). Beyond 30 days, there was no echocardiographic difference between groups. There was no significant difference in clinical outcomes and echocardiographic parameters between standard and ultrasound-assisted CDIs. CDIs provide improved recovery of right ventricular function compared with ST. Major bleeding and stroke complications may be lower, but larger studies are needed to validate this. CDIs are complementary to ST, and their use should be individualized on the basis of the patients' clinical presentation, risk profile, and local resources.

Avgerinos ED ，Abou Ali AN ，Liang NL ，Rivera-Lebron B ，Toma C ，Maholic R ，Makaroun MS ，Chaer RA ... -  《-》

Catheter-directed thrombolysis versus suction thrombectomy in the management of acute pulmonary embolism.

Avgerinos ED ，Abou Ali A ，Toma C ，Wu B ，Saadeddin Z ，McDaniel B ，Al-Khoury G ，Chaer RA ... -  《-》

Catheter-directed therapies for the treatment of high risk (massive) and intermediate risk (submassive) acute pulmonary embolism.

Acute pulmonary embolism (APE) is a major cause of acute morbidity and mortality. APE results in long-term morbidity in up to 50% of survivors, known as post-pulmonary embolism (post-PE) syndrome.  APE can be classified according to the short-term (30-day) risk of mortality, based on a variety of clinical, imaging and laboratory findings. Most mortality and morbidity is concentrated in high-risk (massive) and intermediate-risk (submassive) APE. The first-line treatment for APE is systemic anticoagulation.  High-risk (massive) APE accounts for less than 10% of APE cases and is a life-threatening medical emergency, requiring immediate reperfusion treatment to prevent death. Systemic thrombolysis is the recommended treatment for high-risk (massive) APE. However, only a minority of the people affected receive systemic thrombolysis, due to comorbidities or the 10% risk of major haemorrhagic side effects. Of those who do receive systemic thrombolysis, 8% do not respond in a timely manner. Surgical pulmonary embolectomy is an alternative reperfusion treatment, but is not widely available.  Intermediate-risk (submassive) APE represents 45% to 65% of APE cases, with a short-term mortality rate of around 3%. Systemic thrombolysis is not recommended for this group, as major haemorrhagic complications outweigh the benefit. However, the people at higher risk within this group have a short-term mortality of around 12%, suggesting that anticoagulation alone is not an adequate treatment. Identification and more aggressive treatment of people at intermediate to high risk, who have a more favourable risk profile for reperfusion treatments, could reduce short-term mortality and potentially reduce post-PE syndrome. Catheter-directed treatments (catheter-directed thrombolysis and catheter embolectomy) are minimally invasive reperfusion treatments for high- and intermediate-risk APE. Catheter-directed treatments can be used either as the primary treatment or as salvage treatment after failure of systemic thrombolysis. Catheter-directed thrombolysis administers 10% to 20% of the systemic thrombolysis dose directly into the thrombus in the lungs, potentially reducing the risks of haemorrhagic side effects. Catheter embolectomy mechanically removes the thrombus without the need for thrombolysis, and may be useful for people with contraindications for thrombolysis.  Currently, the benefits of catheter-based APE treatments compared with existing medical and surgical treatment are unclear despite increasing adoption of catheter treatments by PE response teams. This review examines the evidence for the use of catheter-directed treatments in high- and intermediate-risk APE. This evidence could help guide the optimal treatment strategy for people affected by this common and life-threatening condition. To assess the effects of catheter-directed therapies versus alternative treatments for high-risk (massive) and intermediate-risk (submassive) APE. We used standard, extensive Cochrane search methods. The latest search was 15 March 2022. We included randomised controlled trials (RCTs) of catheter-directed therapies for the treatment of high-risk (massive) and intermediate-risk (submassive) APE. We excluded catheter-directed treatments for non-PE. We applied no restrictions on participant age or on the date, language or publication status of RCTs. We used standard Cochrane methods. The main outcomes were all-cause mortality, treatment-associated major and minor haemorrhage rates based on two established clinical definitions, recurrent APE requiring retreatment or change to a different APE treatment, length of hospital stay, and quality of life. We used GRADE to assess certainty of evidence for each outcome. We identified one RCT (59 participants) of (ultrasound-augmented) catheter-directed thrombolysis for intermediate-risk (submassive) APE. We found no trials of any catheter-directed treatments (thrombectomy or thrombolysis) in people with high-risk (massive) APE or of catheter-based embolectomy in people with intermediate-risk (submassive) APE. The included trial compared ultrasound-augmented catheter-directed thrombolysis with alteplase and systemic heparinisation versus systemic heparinisation alone. In the treatment group, each participant received an infusion of alteplase 10 mg or 20 mg over 15 hours. We identified a high risk of selection and performance bias, low risk of detection and reporting bias, and unclear risk of attrition and other bias. Certainty of evidence was very low because of risk of bias and imprecision.  By 90 days, there was no clear difference in all-cause mortality between the treatment group and control group. A single death occurred in the control group at 20 days after randomisation, but it was unrelated to the treatment or to APE (odds ratio (OR) 0.31, 95% confidence interval (CI) 0.01 to 7.96; 59 participants). By 90 days, there were no episodes of treatment-associated major haemorrhage in either the treatment or control group. There was no clear difference in treatment-associated minor haemorrhage between the treatment and control group by 90 days (OR 3.11, 95% CI 0.30 to 31.79; 59 participants). By 90 days, there were no episodes of recurrent APE requiring retreatment or change to a different APE treatment in the treatment or control group. There was no clear difference in the length of mean total hospital stay between the treatment and control groups. Mean stay was 8.9 (standard deviation (SD) 3.4) days in the treatment group versus 8.6 (SD 3.9) days in the control group (mean difference 0.30, 95% CI -1.57 to 2.17; 59 participants). The included trial did not investigate quality of life measures.  AUTHORS' CONCLUSIONS: There is a lack of evidence to support widespread adoption of catheter-based interventional therapies for APE. We identified one small trial showing no clear differences between ultrasound-augmented catheter-directed thrombolysis with alteplase plus systemic heparinisation versus systemic heparinisation alone in all-cause mortality, major and minor haemorrhage rates, recurrent APE and length of hospital stay. Quality of life was not assessed.  Multiple small retrospective case series, prospective patient registries and single-arm studies suggest potential benefits of catheter-based treatments, but they provide insufficient evidence to recommend this approach over other evidence-based treatments. Researchers should consider clinically relevant primary outcomes (e.g. mortality and exercise tolerance), rather than surrogate markers (e.g. right ventricular to left ventricular (RV:LV) ratio or thrombus burden), which have limited clinical utility. Trials must include a control group to determine if the effects are specific to the treatment.

Harvey JJ ，Huang S ，Uberoi R 《Cochrane Database of Systematic Reviews》