Clinical, Functional, and Quality of Life Outcomes after Computer Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study.

PURPOSE: To report 90-day results from the first interim analysis of the STRIKE-PE study, which is evaluating safety, effectiveness, and functional and quality of life (QoL) outcomes of Computer Assisted Vacuum Thrombectomy (CAVT) with the Indigo Aspiration System for the treatment of acute pulmonary embolism (PE). METHODS: STRIKE-PE is a prospective, international, multicenter study that will enroll 600 adult patients with acute PE of ≤14 days and a right ventricle/left ventricle (RV/LV) ratio of ≥0.9 who receive first-line endovascular treatment with CAVT. Primary endpoints are change in RV/LV ratio and incidence of composite major adverse events (MAEs) within 48 hours. Secondary endpoints include functional and QoL assessments. RESULTS: The first 150 consecutive patients were treated with Lightning 12 CAVT. Mean age was 61.3 years, 54.7% were men, 94.7% presented with intermediate-risk PE, and 5.3% presented with high-risk PE. Median thrombectomy and procedure times were 33.5 minutes and 70 minutes, respectively, resulting in a mean reduction in systolic pulmonary artery pressure of 16.3% (P < .001). Mean RV/LV ratio decreased from 1.39 before thrombectomy to 1.01 at 48 hours, a 25.7% reduction (P < .001). Four patients (2.7%) experienced a composite MAE within 48 hours. At 90-day follow-up, patients exhibited statistically significant improvements in the Borg dyspnea scale and QoL measures, and the NYHA class distribution returned to that reported before the index PE. CONCLUSION: These interim results demonstrate a rapid reduction in RV/LV ratio, achieved with a fast thrombectomy time while maintaining safety. This is accompanied by improvements in 90-day functional and QoL outcomes.

Outcomes with catheter-directed thrombolysis compared with anticoagulation alone in patients with acute deep venous thrombosis.

OBJECTIVE: The authors aimed to investigate the benefits and risks of catheter-directed thrombolysis (CDT) in acute deep venous thrombosis (DVT). BACKGROUND: The role of CDT in the management of DVT is evolving. Data on CDT versus anticoagulation alone in acute DVT is sparse. METHODS: We performed a systematic review and meta-analysis of published studies that compared CDT to anticoagulation alone in patients with acute DVT. RESULTS: We included 11 studies (four randomized control trials [RCTs] and seven observational studies) with a total of 8,737 patients. During hospital stay, patients who received CDT had higher odds of major bleeding (2.5% vs. 1.6%; OR 1.46, 95% CI [1.07, 1.98], p = .02), blood transfusion (10.8% vs. 6.2%; OR 1.8, 95% CI [1.52, 2.13], p < .001), and thromboembolism (15.5% vs. 10%; OR 1.67, 95% CI [1.47, 1.91], p < .001) compared with anticoagulation alone. At 6-month follow-up, patients who received CDT had higher venous patency (71.1% vs. 37.7%; OR 5.49, 95% CI [2.63, 11.5], p < .001) and lower postthrombotic syndrome (PTS; 27% vs. 40.7%; OR 0.44, 95% CI [0.22, 0.86], p = .02). During a mean follow-up duration of 30.5 ± 28 months, CDT group continued to have higher venous patency (79.6% vs. 71.8%; OR 3.79, 95% CI [1.54, 9.32], p = .004) and lower PTS (44.7% vs. 50.5%; OR 0.43, 95% CI [0.23, 0.78], p = .006), but no difference in thromboembolism. CONCLUSION: Compared with anticoagulation alone, CDT for patients with acute DVT was associated with a higher risk of complications, but a higher rate of venous patency and lower risk of postthrombotic syndrome at 2.5 years follow-up.

Multicenter experience with the antegrade fenestration and reentry technique for chronic total occlusion recanalization.

OBJECTIVES: We aimed to evaluate the efficacy and safety of antegrade fenestration and reentry (AFR) for chronic total occlusion (CTO) recanalization in a multicenter registry. BACKGROUND: Adoption of antegrade dissection/reentry (ADR) for CTO recanalization has been limited, and novel ADR techniques are needed. METHODS: AFR involves the balloon-induced creation of multiple fenestrations between the false and true lumen. A targeted true lumen reentry is subsequently achieved with a low tip-load polymer-jacketed guidewire. Following the initial description and dissemination of AFR, patients undergoing AFR-based CTO recanalization at nine centers were included in the present registry. Study endpoints were AFR success, procedural success, and target-lesion failure (TLF) on follow-up. RESULTS: We included 41 patients. Mean J-CTO score was 2.5 ± 1.4. In 80.5% of cases, AFR was performed after failed antegrade wire escalation. Another ADR technique was used before AFR in one-third of cases. AFR achieved distal true lumen reentry in n = 27/41 (65.9%) cases. In n = 14/41 (34.1%) cases with AFR failure, use of alternative techniques led to successful CTO recanalization in eight additional patients. The overall technical and procedural success rates were 85.4% and 82.9%, respectively. No AFR-related complications were observed. One-year TLF rate was 8.3% overall, with no differences between successful and failed AFR. CONCLUSIONS: We report on AFR feasibility in a multicenter registry of patients undergoing CTO recanalization. We observed a moderate success rate, coupled with the absence of complications. Moreover, even a failed AFR attempt did not preclude the use of alternative techniques to achieve recanalization. Further studies should confirm and extend our findings.

Improved Outcomes Associated with the use of Shock Protocols: Updates from the National Cardiogenic Shock Initiative.

BACKGROUND: The National Cardiogenic Shock Initiative is a single-arm, prospective, multicenter study to assess outcomes associated with early mechanical circulatory support (MCS) in patients presenting with acute myocardial infarction and cardiogenic shock (AMICS) treated with percutaneous coronary intervention (PCI). METHODS: Between July 2016 and February 2019, 35 sites participated and enrolled into the study. All centers agreed to treat patients with AMICS using a standard protocol emphasizing invasive hemodynamic monitoring and rapid initiation of MCS. Inclusion and exclusion criteria mimicked those of the "SHOCK" trial with an additional exclusion criteria of intra-aortic balloon pump counter-pulsation prior to MCS. RESULTS: A total of 171 consecutive patients were enrolled. Patients had an average age of 63 years, 77% were male, and 68% were admitted with AMICS. About 83% of patients were on vasopressors or inotropes, 20% had a witnessed out of hospital cardiac arrest, 29% had in-hospital cardiac arrest, and 10% were under active cardiopulmonary resuscitation during MCS implantation. In accordance with the protocol, 74% of patients had MCS implanted prior to PCI. Right heart catheterization was performed in 92%. About 78% of patients presented with ST-elevation myocardial infarction with average door to support times of 85 ± 63 min and door to balloon times of 87 ± 58 min. Survival to discharge was 72%. Creatinine ≥2, lactate >4, cardiac power output (CPO) <0.6 W, and age ≥ 70 years were predictors of mortality. Lactate and CPO measurements at 12-24 hr reliably predicted overall mortality postindex procedure. CONCLUSION: In contemporary practice, use of a shock protocol emphasizing best practices is associated with improved outcomes.

Future perspectives in catheter-based treatment of pulmonary embolism.

Pulmonary embolism is the third commonest cause of cardiovascular death globally. The majority of such patients present with low-risk features and can be managed with simple anticoagulation; however, a large group of patients exhibit evidence of right ventricular dysfunction on echocardiography or CT at the time of presentation and these patients are at risk of early haemodynamic compromise, particularly in those with abnormal cardiac biomarkers. Catheter-directed thrombolysis has been proposed as a treatment-strategy for patients with pulmonary embolism with evidence of acute right ventricular dysfunction. We review the current technologies in mainstream use, the evidence base in support of their use and discuss future research requirements in this area.

Crush techniques for percutaneous coronary intervention of bifurcation lesions.

Percutaneous coronary intervention (PCI) of coronary artery bifurcation lesions entails technical challenges and carries a higher risk of adverse events on follow-up, driven by repeat revascularisation and stent thrombosis. While most bifurcations can be tackled with a provisional (single-stent) approach, more complex lesions involving both branches (true bifurcation lesions) require a two-stent approach. In the latter context, several techniques have been proposed. Among them, the crush technique has dramatically evolved in recent years, and its more recent iterations have been shown to provide excellent and durable results, both for left main and non-left main bifurcations. The aim of the present work is to discuss the technical aspects and outcomes of the variants of the crush technique from the first description in the early 2000s to the present day.

Acute Profound Thrombocytopenia Induced by Eptifibatide Causing Diffuse Alveolar Hemorrhage.

BACKGROUND: Eptifibatide is a glycoprotein IIb/IIIa (GP IIb/IIIa) receptor inhibitor which prevents platelet activation. The mechanism in which eptifibatide causes profound thrombocytopenia is poorly understood. One hypothesis suggests antibody-dependent pathways which cause thrombocytopenia upon subsequent reexposure to eptifibatide. This case reports acute profound thrombocytopenia (platelets < 20 × 103/mm3) within 24 hours of administration. Alveolar hemorrhage occurred during a second eptifibatide infusion 5 days after initial asymptomatic eptifibatide treatment. Case Presentation. A 50-year-old male presenting with a STEMI was treated with eptifibatide during cardiac catheterization. Twelve hours posttreatment, the patient encountered profound thrombocytopenia and hemoptysis. The patient was briefly intubated for airway protection. The patient was stabilized after receiving platelet transfusion and fully recovered. CONCLUSION: This is one of several cases reported on eptifibatide causing acute profound thrombocytopenia and subsequent alveolar hemorrhage. This case supports the theory in which antibodies contribute to eptifibatide-induced thrombocytopenia.

Percutaneous Impella Mechanical Circulatory Support Delivery Using Intravascular Lithotripsy.

Intravascular lithotripsy (IVL) may be useful to deliver Impella devices in patients with peripheral arterial disease. Twelve patients were treated with peripheral IVL prior to Impella insertion. A total of 100% of patients underwent successful device implantation with no IVL complications. IVL can facilitate transfemoral access for Impella insertion. (Level of Difficulty: Advanced.).

Tryton dedicated bifurcation stent in treatment of unprotected distal left main bifurcation disease.

Percutaneous coronary interventions involving coronary bifurcation lesions are more complex and associated with adverse outcomes (both angiographic and clinical) compared to non-bifurcation lesions. Tryton, a dedicated bifurcation stent, has been introduced with the aim to simplify treatment of bifurcation lesions. Tryton stent in combination with conventional drug eluting stent is safe and associated with reduced stenosis and bail-out stenting of side branch compared to provisional stenting involving a large side. However, little is known regarding safety and efficacy of Tryton stent in left main (LM) bifurcation lesion. We describe two cases of unprotected LM bifurcation stenting using Tryton stent in combination with drug eluting stent.

Early Versus Delayed Use of Ultrasound-Assisted Catheter-Directed Thrombolysis in Patients With Acute Submassive Pulmonary Embolism.

OBJECTIVES: The effect of early vs delayed use of ultrasound-assisted catheter-directed thrombolysis (USAT) on invasive hemodynamics and in-hospital outcomes in patients with acute submassive pulmonary embolism (PE) is not well known. METHODS: We evaluated 41 patients with submassive PE to study the association of early USAT (≤24 hours; n = 21) vs delayed USAT (>24 hours; n = 20) with change in invasive hemodynamic measures from pre USAT to post USAT. RESULTS: Significantly greater improvement was observed in the early USAT group compared to the delayed group for median cardiac index (0.6 L/min/m² [IQR, 0.4-1.1 L/min/ m²] vs 0.4 L/min/m² [IQR, 0.1-0.6 L/min/m²]; P=.03), median pulmonary vascular resistance (3.4 Wood units [IQR, 2.5-4.1 Wood units] vs 0.5 Wood units [IQR, 0.2-1.3 Wood units]; P<.001), and mean right ventricular stroke work index (3.5 ± 2.0 g-m/m²/beat vs 2.3 ± 1.6 g-m/m2/beat; P=.04). Although not statistically significant, a trend in favor of early treatment was found for improvement in mean right ventricle to left ventricle diameter ratio (0.38 ± 0.17 vs 0.33 ± 0.21; P=.40), mean pulmonary artery pressure (8.4 ± 7.1 mm Hg vs 5.3 ± 5.2 mm Hg; P=.13), and median pulmonary artery pulsatility index (1.14 [IQR, 2.01-0.45] vs 0.65 [IQR, 0.22-1.78]; P=.49). The mean postprocedural length of stay was significantly lower in the early-USAT group (6.0 ± 2.7 days vs 10.1 ± 7.0 days; P=.02). Three patients experienced moderate bleeding (2 patients in the early-USAT group and 1 patient in the delayed-USAT group) and no major bleeds or in-hospital mortality occurred. CONCLUSION: Early USAT was associated with greater improvement in pulmonary hemodynamics and shorter postprocedural length of stay compared with delayed USAT in patients with acute submassive PE.

Caught in Time: When IVC Filters Save Lives.

Inferior vena cava filters are indicated in patients with venous thromboembolic disease in whom anticoagulation is a contraindication. This case highlights the importance of inferior vena cava filter placement in patients with extensive proximal deep vein thromboses in order to prevent massive pulmonary emboli, possibly associated with sudden cardiac death.