Randomized Controlled Trial of Mechanical Thrombectomy Versus Catheter-directed Thrombolysis for Acute Hemodynamically Stable Pulmonary Embolism: Rationale and Design of the PEERLESS Study.

BACKGROUND The identification of hemodynamically stable pulmonary embolism (PE) patients who may benefit from advanced treatment beyond anticoagulation is unclear. However, when intervention is deemed necessary by the PE patient's care team, data to select the most advantageous interventional treatment option are lacking. Limiting factors include major bleeding risks with systemic and locally delivered thrombolytics and the overall lack of randomized controlled trial (RCT) data for interventional treatment strategies. Considering the expansion of the Pulmonary Embolism Response Team (PERT) model, corresponding rise in interventional treatment, and number of thrombolytic and non-thrombolytic catheter-directed devices coming to market, robust evidence is needed to identify the safest and most effective interventional option for patients. METHODS The PEERLESS study (ClinicalTrials.gov identifier: NCT05111613) is a currently enrolling multinational RCT comparing large-bore mechanical thrombectomy (MT) with the FlowTriever System (Inari Medical, Irvine, CA) vs catheter-directed thrombolysis (CDT). A total of 550 hemodynamically stable PE patients with right ventricular (RV) dysfunction and additional clinical risk factors will undergo 1:1 randomization. Up to 150 additional patients with absolute thrombolytic contraindications may be enrolled into a non-randomized MT cohort for separate analysis. The primary endpoint will be assessed at hospital discharge or 7 days post procedure, whichever is sooner, and is a composite of the following clinical outcomes constructed as a hierarchal win ratio: 1) all-cause mortality, 2) intracranial hemorrhage, 3) major bleeding, 4) clinical deterioration and/or escalation to bailout, and 5) intensive care unit admission and length of stay. The first 4 components of the win ratio will be adjudicated by a Clinical Events Committee, and all components will be assessed individually as secondary endpoints. Other key secondary endpoints include all-cause mortality and readmission within 30 days of procedure and device- and drug-related serious adverse events through the 30-day visit. IMPLICATIONS PEERLESS is the first RCT to compare two different interventional treatment strategies for hemodynamically stable PE and results will inform strategy selection after the physician or PERT determines advanced therapy is warranted

Randomized Controlled Trial of Mechanical Thrombectomy vs Catheter-Directed Thrombolysis for Acute Hemodynamically Stable Pulmonary Embolism: Rationale and Design of the PEERLESS Study

BACKGROUND: The identification of hemodynamically stable pulmonary embolism (PE) patients who may benefit from advanced treatment beyond anticoagulation is unclear. However, when intervention is deemed necessary by the PE patient\u27s care team, data to select the most advantageous interventional treatment option are lacking. Limiting factors include major bleeding risks with systemic and locally delivered thrombolytics and the overall lack of randomized controlled trial (RCT) data for interventional treatment strategies. Considering the expansion of the pulmonary embolism response team (PERT) model, corresponding rise in interventional treatment, and number of thrombolytic and nonthrombolytic catheter-directed devices coming to market, robust evidence is needed to identify the safest and most effective interventional option for patients. METHODS: The PEERLESS study (ClinicalTrials.gov identifier: NCT05111613) is a currently enrolling multinational RCT comparing large-bore mechanical thrombectomy (MT) with the FlowTriever System (Inari Medical, Irvine, CA) vs catheter-directed thrombolysis (CDT). A total of 550 hemodynamically stable PE patients with right ventricular (RV) dysfunction and additional clinical risk factors will undergo 1:1 randomization. Up to 150 additional patients with absolute thrombolytic contraindications may be enrolled into a nonrandomized MT cohort for separate analysis. The primary end point will be assessed at hospital discharge or 7 days post procedure, whichever is sooner, and is a composite of the following clinical outcomes constructed as a hierarchal win ratio: (1) all-cause mortality, (2) intracranial hemorrhage, (3) major bleeding, (4) clinical deterioration and/or escalation to bailout, and (5) intensive care unit admission and length of stay. The first 4 components of the win ratio will be adjudicated by a Clinical Events Committee, and all components will be assessed individually as secondary end points. Other key secondary end points include all-cause mortality and readmission within 30 days of procedure and device- and drug-related serious adverse events through the 30-day visit. IMPLICATIONS: PEERLESS is the first RCT to compare 2 different interventional treatment strategies for hemodynamically stable PE and results will inform strategy selection after the physician or PERT determines advanced therapy is warranted

Isolated Metatarsal Artery Balloon Angioplasty for Toe Salvage in Critical Limb Ischemia: A Case Report

Purpose: To report a case of percutaneous balloon angioplasty (PTA) performed in the second metatarsal artery for treatment of a non-healing forefoot wound without proximal intervention. Methods and Results: An 80-year-old diabetic woman with a 1.5-year history of a non-healing right second digit ulcer refractory to conservative management underwent a lower extremity arteriogram. Angiography demonstrated unobstructed flow from the aortic bifurcation through to the pedal arch, with an isolated occluded segment in the second metatarsal artery wound supply. This was treated with 1.5 mm balloon angioplasty, with completion angiography demonstrating restored flow to the wound base. There were no procedural events and the wound completely healed after 9 months. Conclusion: Isolated angioplasty of the arteries distal to the pedal arch may be technically feasible and clinically valuable in selected cases

Percutaneous renal artery stent placement for hypertension and azotemia: pilot study.

To evaluate the efficacy of balloon-expandable (Palmaz) stents in the treatment of atheromatous renal artery stenosis, prospective placement of stents in 24 arteries in 20 patients was performed over an 18-month period. Indications were hypertension in 18 patients and renal insufficiency (serum creatinine \u3e 1.5 mg/dL) in 11, and all lesions failed conventional transluminal angioplasty. Technical success was achieved in 96% of cases. Hypertension benefit was noted in 77% of patients followed for 6 months (n = 13) and 67% of patients at 1 year (n = 8). Improvement in serum creatinine was seen in 71% (n = 7) and 100% (n = 3) of azotemic patients evaluated at 6 and 12 months, respectively. Six-month angiographic patency was identified in 13 of 16 treated sites. Renal artery stent placement resulted in one asymptomatic segmental branch occlusion; there were no other procedural complications. In conclusion, renal artery stent placement is a technically and clinically effective treatment for hypertension and azotemia due to renal artery stenosis

Contrast-induced nephropathy

Contrast-induced nephropathy (CIN) has been extensively studied since the 1950s due, in part, to its devastating adverse events. The intellectual push for additional investigation into pathogenesis and prevention has heightened in recent years due to increased utilization of contrast enhanced imaging studies. Lack of a universal CIN definition and varied glomerular filtration rate markers have resulted in a varied reported incidence. Risk assessment and risk reduction strategies have evolved over the past several years. Current evidence supports volume supplementation before the administration of intravascular contrast to reduce the hazard of CIN. Other strategies to reduce the risk of CIN, including low osmolar contrast media, N-acetylcysteine, and intrarenal fenoldopam therapy, have variable levels of evidence, and further randomized trials are necessary

Patient-specific simulation of endovascular thoracic aortic repair : initial experience

PURPOSE: Endovascular thoracic aortic repair (TEVAR) has become the treatment modality of diverse aortic pathology. We report the use of patient-specific simulation using a dedicated PROcedure Rehearsal Studio (PRS) platform (Simbionix USA Corp, Cleveland, OH) before TEVAR and evaluate the feasibility and realism of this technology. DESCRIPTION: Virtual three-dimensional models of the patient's relevant anatomy were reconstructed from computed tomography data. PRS was used in 2 patients before TEVAR. In a multicenter retrospective study, we evaluated how PRS compares with real TEVAR. EVALUATION: PRS before TEVAR was feasible and demonstrated good correlation with the actual procedure. In the retrospective study, 16 patients were reconstructed (median duration, 26 minutes; interquartile range, 21 to 36 minutes). The realism of the simulated angiographies was rated highly (median, 4; interquartile range, 3 to 4). Final angiography revealed type I endoleak in 2 simulated cases and 1 real case. CONCLUSION: Patient-specific rehearsal before TEVAR is feasible and permits the creation of realistic case studies; however, software updates are required to improve face validity and to foster implementation in clinical practice