Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months.

OBJECTIVE: To determine the safety and effectiveness of vena cava filters (VCFs). METHODS: A total of 1429 participants (62.7 ± 14.7 years old; 762 [53.3% male]) consented to enroll in this prospective, nonrandomized study at 54 sites in the United States between October 10, 2015, and March 31, 2019. They were evaluated at baseline and at 3, 6, 12, 18, and 24 months following VCF implantation. Participants whose VCFs were removed were followed for 1 month after retrieval. Follow-up was performed at 3, 12, and 24 months. Predetermined composite primary safety (freedom from perioperative serious adverse events [AEs] and from clinically significant perforation, VCF embolization, caval thrombotic occlusion, and/or new deep vein thrombosis [DVT] within 12-months) and effectiveness (composite comprising procedural and technical success and freedom from new symptomatic pulmonary embolism [PE] confirmed by imaging at 12-months in situ or 1 month postretrieval) end points were assessed. RESULTS: VCFs were implanted in 1421 patients. Of these, 1019 (71.7%) had current DVT and/or PE. Anticoagulation therapy was contraindicated or had failed in 1159 (81.6%). One hundred twenty-six (8.9%) VCFs were prophylactic. Mean and median follow-up for the entire population and for those whose VCFs were not removed was 243.5 ± 243.3 days and 138 days and 332.6 ± 290 days and 235 days, respectively. VCFs were removed from 632 (44.5%) patients at a mean of 101.5 ± 72.2 days and median 86.3 days following implantation. The primary safety end point and primary effectiveness end point were both achieved. Procedural AEs were uncommon and usually minor, but one patient died during attempted VCF removal. Excluding strut perforation greater than 5 mm, which was demonstrated on 31 of 201 (15.4%) patients' computed tomography scans available to the core laboratory, and of which only 3 (0.2%) were deemed clinically significant by the site investigators, VCF-related AEs were rare (7 of 1421, 0.5%). Postfilter, venous thromboembolic events (none fatal) occurred in 93 patients (6.5%), including DVT (80 events in 74 patients [5.2%]), PE (23 events in 23 patients [1.6%]), and/or caval thrombotic occlusions (15 events in 15 patients [1.1%]). No PE occurred in patients following prophylactic placement. CONCLUSIONS: Implantation of VCFs in patients with venous thromboembolism was associated with few AEs and with a low incidence of clinically significant PEs.

Percutaneous debulking of tricuspid vegetations due to infectious endocarditis in pregnancy: a case report.

Infective endocarditis is a rare but serious disease with increasing prevalence in women of childbearing age because of the opioid epidemic. Therefore, it is an increasingly frequent pregnancy complication. The gold standard of treatment is intravenous antibiotics with surgery reserved for refractory cases. However, pregnancy complicates decisions about the risk and timing of surgery. AngioVac represents a percutaneous alternative to surgical intervention. Here, we present a case of a 22-year-old G2P1001 woman with a history of intravenous drug use and infective endocarditis who continued to show signs and symptoms of septic pulmonary emboli despite management with intravenous antibiotics. The patient was deemed not to be a surgical candidate while pregnant and had an AngioVac procedure at 30 2/7 weeks of gestation with the removal of tricuspid vegetations. The patient was delivered via cesarean delivery at 32 5/7 weeks of gestation because of a nonreassuring fetal heart tracing. The patient's tricuspid valve was replaced on postpartum day 16. This case demonstrates that AngioVac can be safely used in the third trimester of pregnancy and may be considered in consultation with a multidisciplinary team for the management of infective endocarditis refractory to antibiotic treatment as an interim measure until surgery can be safely performed.

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.

Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE): Outcomes at 12 months.

OBJECTIVE: To determine the safety and effectiveness of vena cava filters (VCFs). METHODS: A total of 1429 participants (62.7 ± 14.7 years old; 762 [53.3% male]) consented to enroll in this prospective, nonrandomized study at 54 sites in the United States between October 10, 2015, and March 31, 2019. They were evaluated at baseline and at 3, 6, 12, 18, and 24 months following VCF implantation. Participants whose VCFs were removed were followed for 1 month after retrieval. Follow-up was performed at 3, 12, and 24 months. Predetermined composite primary safety (freedom from perioperative serious adverse events [AEs] and from clinically significant perforation, VCF embolization, caval thrombotic occlusion, and/or new deep vein thrombosis [DVT] within 12-months) and effectiveness (composite comprising procedural and technical success and freedom from new symptomatic pulmonary embolism [PE] confirmed by imaging at 12-months in situ or 1 month postretrieval) end points were assessed. RESULTS: VCFs were implanted in 1421 patients. Of these, 1019 (71.7%) had current DVT and/or PE. Anticoagulation therapy was contraindicated or had failed in 1159 (81.6%). One hundred twenty-six (8.9%) VCFs were prophylactic. Mean and median follow-up for the entire population and for those whose VCFs were not removed was 243.5 ± 243.3 days and 138 days and 332.6 ± 290 days and 235 days, respectively. VCFs were removed from 632 (44.5%) patients at a mean of 101.5 ± 72.2 days and median 86.3 days following implantation. The primary safety end point and primary effectiveness end point were both achieved. Procedural AEs were uncommon and usually minor, but one patient died during attempted VCF removal. Excluding strut perforation greater than 5 mm, which was demonstrated on 31 of 201 (15.4%) patients' computed tomography scans available to the core laboratory, and of which only 3 (0.2%) were deemed clinically significant by the site investigators, VCF-related AEs were rare (7 of 1421, 0.5%). Postfilter, venous thromboembolic events (none fatal) occurred in 93 patients (6.5%), including DVT (80 events in 74 patients [5.2%]), PE (23 events in 23 patients [1.6%]), and/or caval thrombotic occlusions (15 events in 15 patients [1.1%]). No PE occurred in patients following prophylactic placement. CONCLUSIONS: Implantation of VCFs in patients with venous thromboembolism was associated with few AEs and with a low incidence of clinically significant PEs.

Effect of metabolic syndrome on mean pulmonary arterial pressures in patients with acute pulmonary embolism treated with catheter-directed thrombolysis.

BACKGROUND: Metabolic syndrome (MetS) has been associated with a procoagulant and hypofibrinolytic state. Current data exploring the role of MetS in venous thromboembolism (VTE) are limited. The objective was to measure the prevalence of MetS in patients with acute PE receiving catheter-directed thrombolysis (CDT) and to investigate its effect on mean pulmonary arterial pressure and overall treatment success. METHODS: We used a 3-year prospective registry of ED patients with acute PE with severity qualifying for activation of a PE response team (PERT). All patients had CDT with catheter-measured mPAP and angiography. The presence or absence of MetS components were extracted from chart review based on the following criteria: 1. body mass index (BMI) >30 kg/m2; 2. diagnosed hypertension; 3. diabetes mellitus (including HbA1c >6.5%) and; 4. dyslipidemia (including triglycerides >150 mg/dL or high-density lipoprotein <40 mg/dL). RESULTS: Of the 134 patients, 85% met the criteria for at least one of four MetS components, with obesity being most common, present in 71%. Results demonstrated a positive concordance between the number of criteria for MetS and MPAP, both pre- and post-fibrinolysis, as pressures tended to increase with each additional MetS criterion. Multivariate regression analysis determined age (-), BMI (+) and hypertension (+) to be significant independent predictor variables for mPAP. CONCLUSIONS: MetS was common in patients with more severe manifestations of PE and was associated with higher mPAP values both at diagnosis and following treatment with CDT.

A successful percutaneous mechanical vegetation debulking used as a bridge to surgery in acute tricuspid valve endocarditis.

Timing of surgical management of acute infective endocarditis is a major challenge, with respect to surgical complications, risks of recurrences and optimal valve repair or replacement. We present a case of a 24-year-old male with a history of intravenous drug abuse, who was referred to our center after 10 days of medical management of acute infective endocarditis. Upon arrival he was in septic shock, multi-organ failure, and mobile vegetations on the tricuspid valve with severe tricuspid regurgitation. He also had bilateral pulmonary infarcts and an ischemic stroke in the right parietal lobe. A successful percutaneous transcatheter mechanical vegetation debulking was performed followed by surgical valve replacement seven days later. This case introduces a new option in the management of right-sided endocarditis in critically ill patient, and demonstrates the technical feasibility of a debulking procedure in this setting, which led subsequently to a significant improvement in patient's condition, and he was ultimately able to undergo definitive surgery.

Time to hemostasis after traction removal of tunneled cuffed central venous catheters.

PURPOSE: Many patients undergo placement of tunneled cuffed central venous catheters (TCCVCs) for indications including administration of medical therapy and hemodialysis. They are removed when no longer needed or if there is a device complication. There is no consensus regarding the necessity of routine preremoval coagulation studies or platelet count, so this study was performed to determine if abnormal coagulation status affects the time to hemostasis (TH) after traction removal of TCCVCs. MATERIALS AND METHODS: Adult patients referred to our group for removal of a TCCVC placed via a jugular or subclavian route were considered candidates for inclusion. Blood was submitted for evaluation of prothrombin time (PT) and International Normalized Ratio (INR), activated partial thromboplastin time (aPTT), and platelet count. Catheters were removed with the traction technique, and presence of hemostasis was assessed at 5-minute intervals of manual compression. RESULTS: Between November 19, 2001, and April 20, 2004, 179 subjects were enrolled and completed the study. There were 165 subjects in whom TH was within the first 5-minute interval and 14 in whom more than 5 minutes was required. Statistically significant factors associated with prolonged TH were primary diagnosis of end-stage renal disease (P = .005), use of antiplatelet agents (P = .03), and procedure performed by a "low-volume" operator (P = .002). CONCLUSIONS: Routine preremoval evaluation of coagulation parameters is not necessary. Patients who are likely to have abnormal platelet function but not abnormal platelet number appear to be at risk for prolonged TH, but even in those cases, the THs are rarely more than 15 minutes.

Percutaneous stent placement as treatment of renal vein obstruction due to inferior vena caval thrombosis.

A patient who had undergone his third orthotopic liver transplantation nearly 9 years prior to presentation developed worsening hepatic and renal function, as well as severe bilateral lower extremity edema. Magnetic resonance imaging demonstrated vena caval thrombosis from the suprahepatic venous anastomosis to the infrarenal inferior vena cava, obstructing the renal veins. This was treated by percutaneous placement of metallic stents from the renal veins to the right atrium. At 16 months clinical follow-up, the patient continues to do well.