Large-bore Aspiration Thrombectomy with the FlowTriever System for the Treatment of Pulmonary Embolism: A Large Single-Center Retrospective Analysis.

PURPOSE: Evaluate the outcomes of patients undergoing large-bore aspiration thrombectomy for the treatment of pulmonary embolism at a large university medical center. MATERIALS AND METHODS: All patients treated for pulmonary embolism with the FlowTriever System (Inari Medical, Irvine, CA) between September 2019 and January 2023 were retrospectively analyzed. The primary safety and effectiveness outcomes included 7- and 30-day all-cause mortality, major bleeding, procedure-associated clinical decompensation, pulmonary vascular or cardiac injury, and pulmonary artery pressure reduction. Additional outcomes included technical success (completing thrombectomy with the device as intended), changes in hemodynamics and supplemental oxygen requirements, and postprocedural intensive care unit stay. RESULTS: A total of 286 patients were identified. The mean age was 60.5 years, and 90.9% of patients presented with intermediate-risk pulmonary embolism. Technical success was achieved in 96.9% (n = 277) of cases. The average reduction in mean pulmonary arterial pressure was 6.8 mmHg, from 28.7 ± 9.0 to 21.9 ± 8.0 mmHg (p < 0.0001). Two major bleeds (0.7%), 2 pulmonary vascular injuries (0.7%), and 4 (1.4%) procedure-associated decompensations were reported, but no device-related deaths occurred. The mean post-procedure intensive care unit stay was 2.0 ± 4.1 days, and 49.3% of patients had no postprocedural intensive care unit admittance. The overall 7-day and 30-day all-cause mortality rates were 2.4% and 6.7%, respectively, with a 30-day pulmonary embolism-related mortality rate of 3.5%. CONCLUSION: This non-industry-sponsored single-center analysis of large-bore aspiration thrombectomy in a large population corroborates the findings of other studies and confirms that this approach is safe and effective for the treatment high- and intermediate-risk pulmonary embolism. LEVEL OF EVIDENCE IV: Retrospective observational study.

Clinical Efficacy of Percutaneous Vegetectomy in Tricuspid and Right-Heart Indwelling Device Infective Endocarditis.

Several studies have analyzed the efficacy of AngioVac for percutaneous intracardiac vegetectomy, but impact on surgical candidacy or clinical efficacy for infectious endocarditis (IE) is currently unknown. This is a single-arm, retrospective study on IE vegetectomy with impact on surgical risk scores. Analysis included 32 patients who underwent AngioVac vegetectomy for right heart IE at a single institution. The primary endpoint was improvement in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) scores. Secondary endpoints included technical success, improved leukocytosis, procedural safety, 30-day mortality, and 60-day mortality. Findings demonstrate 90.6% (n = 29) technically successful debulking. There was improvement in mean NSQIP scores from 34.6 to 27.9 (P = .007). Zero cases of 30-day all-cause mortality. One patient experienced a major post-procedural complication of pneumothorax, a Class D Adverse Event. 20.5% (n = 5) of valvular vegetation patients went on to have surgical tricuspid valve repair. All indwelling intracardiac devices were removed. Findings suggest that percutaneous vegetectomy improves surgical candidacy, as measured by ACS NSQIP scores, in patients with IE and right heart vegetations and is associated with low complication rates.

Clinical and imaging outcomes of OptionELITE vena cava filter placement procedures.

OBJECTIVE: We sought to determine the clinical and imaging outcomes after placement of the OptionELITE inferior vena cava (IVC) filter (Argon Medical Devices, Plano, TX). METHODS: The clinical characteristics and imaging findings of patients who had undergone OptionELITE filter placement at six affiliated hospitals between January 1, 2013 and April 19, 2019, were analyzed. Data were obtained from the Radiology Information System, imaging database, and electronic medical records. The patients were followed up until 1 month after filter removal, death, or the first clinic visit and imaging study after June 1, 2019. RESULTS: A total of 603 filter placement procedures in 594 patients were evaluated. Of the 603 procedures, 602 were technically successful (99.8%). Of the 594 patients, 356 had presented with acute pulmonary embolism and/or deep vein thrombosis. A total of 189 filters were retrieved from the 191 patients for whom retrieval had been attempted at 4.3 ± 6.3 months (median, 2.5 months) after placement. The 414 filters without removal procedures had been followed up for 14.8 ± 17.7 months (median, 6.9 months). During the follow-up period, 57 patients (9.5%) had developed new or worsening deep vein thrombosis caudal to the filter and 19 (3.2%) had experienced new symptomatic nonfatal pulmonary embolism after filter placement. One filter had migrated and fractured, and another filter had fractured and a strut was lost. Perforation was demonstrated equivocally in 12 (3%) and definitely in 17 (4.3%) of 399 patients with adequate imaging studies available, with penetration into surrounding structures in 13 patients (3.3%). Of 332 patients with adequate imaging studies, 12 (3.6%) had developed substantial IVC thrombosis and 4 (1.2%) had developed IVC occlusion. CONCLUSIONS: The rates of symptomatic pulmonary embolism and filter-related complications were low after OptionELITE IVC filter placement, and filter retrieval, when attempted, was 99% successful.

Repeat angiography in patients undergoing conventional catheter-directed thrombolysis for submassive pulmonary embolism: a large single-center experience.

PURPOSE: Few studies have examined conventional catheter directed thrombolysis (CDT) for the treatment of submassive pulmonary embolism (PE). Moreover, angiographic resolution of thrombus burden following CDT has infrequently been characterized. This study describes a single-center experience treating submassive PE with CDT while utilizing repeat angiography to determine treatment efficacy. METHODS: A retrospective analysis of 140 consecutive patients who underwent CDT for submassive PE from December 2012 to June 2019 was performed. Angiographic resolution of thrombus burden after CDT was reported as high (>75%), moderate (51-75%), low (26-50%), or insignificant (≤25%). All angiograms were reviewed by two interventional radiologists. Secondary endpoints included reduction in pulmonary artery pressure (PAP) and clinical outcomes. Bleeding events were classified according to the Society of Interventional Radiology (SIR) adverse event criteria. RESULTS: CDT was performed in 140 patients with a mean rtPA dose of 25.3 mg and a mean treatment time of 26.0 hours. Angiographic resolution of thrombus burden was high in 70.0%, moderate in 19.3%, low in 5.7%, and insignificant in 3.6%; in 2 patients (1.4%) repeat angiography was not performed. Systolic PAP was reduced (47 vs. 35 mmHg, p < 0.001), mean PAP was reduced (25 vs 21 mmHg, p < 0.001), and 129 patients (92.1%) improved clinically. Patients with high or moderate resolution of thrombus burden had a clinical improvement rate of 95.2%, while patients with low or insignificant thrombus burden resolution had a clinical improvement rate of 76.9% (p=0.011). Ten patients (7.1%) had hemodynamic or respiratory decompensation requiring mechanical ventilation, systemic thrombolysis, cardiopulmonary resuscitation, or surgical intervention. Seven patients (5.0%) experienced moderate bleeding events and one patient (0.7%) with metastatic disease developed severe gastrointestinal bleeding that resulted in death. Thirty-day mortality was 1.4%. CONCLUSION: In patients with submassive PE undergoing CDT, angiographic resolution of thrombus burden is a safe and directly observable metric that can be used to determine procedural success. In this study, CDT with repeat angiography was associated with a 5.7% bleeding event rate and thirty-day mortality of 1.4%.

Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation Prior to Abdominal Operation: a Retrospective Analysis.

PURPOSE: Transjugular intrahepatic portosystemic shunt (TIPS) creation is most commonly performed for patients with refractory ascites or variceal hemorrhage. While TIPS have also been created prior to planned abdominal operation to decrease morbidity related to portal hypertension, there are limited data supporting its effectiveness in that indication. The goal of this study was to determine if preoperative TIPS creation allows for successful abdominal operation with limited morbidity. METHODS: A retrospective review of records of 22 consecutive patients who underwent TIPS creation for the specific indication of improving surgical candidacy, between 2011 and 2016, was performed. Clinical and serologic data were obtained for 21 patients (one patient was excluded since she was completely lost to follow-up after TIPS creation). The primary endpoint was whether patients underwent planned abdominal operation following TIPS. Operative outcomes and reasons that patients failed to undergo planned operation were examined as secondary endpoints. The mean age was 56.4 ± 8.8 years and the mean Child-Pugh and Model for End-Stage Liver Disease (MELD) scores were 7.2 ± 1.5 and 11.9 ± 4.3, respectively. RESULTS: TIPS creation was performed in all 21 patients with a 30-day mortality rate of 9.5%. Eleven patients (52.4%) subsequently underwent abdominal operation after which the 30-day postoperative mortality rate was 0%. One patient (9.1%) had major perioperative morbidity related to portal hypertension and presented with surgical wound dehiscence and infection requiring drain placement and antibiotic therapy. CONCLUSIONS: In this population, TIPS allowed successful abdominal operation in the majority of patients, with 30-day TIPS mortality of 9.5%, no perioperative mortality, and 9.1% major postoperative morbidity attributable to portal hypertension.