A cross-sectional study of outcomes for patients undergoing mechanical thrombectomy for pulmonary embolism during 2018-2022: Insights from the PINC AI Healthcare Database.

Background and Aims: Mechanical thrombectomy (MT) treatments for pulmonary embolism (PE) have yet to be compared directly. We aimed to determine if patient outcomes varied following treatment of PE with different MT devices. Methods: All PE encounters with an index treatment of MT between January 2018 and March 2022 were analyzed for in-hospital mortality, discharge to home, and 30-day readmission outcomes in the PINC AI™ Healthcare Database. MT devices used in each encounter were extracted from hospital charge description free-text fields using keyword text and fuzzy matching. Unadjusted and adjusted logistic regression was used to model outcomes by device. Results: A total of 5893 encounters were identified using MT as the sole index PE treatment and 1812 using MT with another treatment. Of these, 41% had insufficient information to identify the devices used (unspecified MT), 33% used the FlowTriever System (large-bore volume-controlled aspiration MT), 23% the Indigo System (continuous aspiration MT), and 3% some other MT. Large-bore volume-controlled aspiration MT was used with other treatments 13% of the time compared with 23% and 39% for unspecified MT and continuous aspiration MT, respectively. Adjusted logistic regression modeling revealed the odds of in-hospital mortality were significantly higher for patients treated with unspecified MT ([OR] = 1.42, 95% confidence interval [CI]: [1.10-1.83], p = 0.008) or continuous aspiration MT (OR = 1.63, 95% CI: [1.21-2.19], p = 0.001) compared with large-bore volume-controlled aspiration MT. Discharge to home was significantly lower in these same groups (OR = 0.84, 95% CI: [0.73-0.96], p = 0.01, and OR = 0.63, 95% CI: [0.53-0.74], p < 0.001, respectively), but readmission risks at 30 days were comparable (OR = 1.08, 95% CI: [0.84-1.38], p = 0.56, and OR = 1.20, 95% CI: [0.89-1.62], p = 0.24, respectively). Conclusion: PE outcomes and treatment patterns differ significantly based on the type of MT utilized. Clinical studies directly comparing MT treatments are needed to further understand optimal treatment of PE.

Trends in Percutaneous Device Use for the Treatment of Venous Thromboembolism Over Time in the PINC AI Healthcare Database and the National Inpatient Sample.

The number of different methods of reperfusion therapy to treat venous thromboembolism (VTE) has increased substantially. Nevertheless, investigation of data representativeness and device-level use in administrative databases has been limited. Using the National Inpatient Sample (NIS) and the PINC AI Healthcare Database (PHD), all hospital encounters with a diagnosis code of VTE were identified between January 1, 2016 and December 31, 2020. Patient demographics and trends in treatment modalities were evaluated over time. An algorithm was developed to identify specific devices used for VTE treatment in the PHD cohort. A total of 145,870 patients with VTE treated with reperfusion therapy were identified in the NIS (pulmonary embolism [PE] 88,725, isolated deep vein thrombosis [iDVT] 57,145) and 39,311 in the PHD (PE 25,383, iDVT 13,928). Patient demographics were qualitatively similar in the NIS and PHD. Over time, there was a significant increase in the use of mechanical thrombectomy in the PE and iDVT populations (p <0.05 in both databases), with catheter-directed thrombolysis use plateauing in PE (p = 0.83 and p = 0.14 in NIS and PHD, respectively) and significantly decreasing for the iDVT population (p <0.05 in both databases). In the PHD cohort, specific reperfusion devices were identified in 14,105 patients (PE 9,098, iDVT 5,007). In conclusion, the use of mechanical thrombectomy for the treatment of VTE has increased over time, whereas the rates of catheter-directed thrombolysis therapy have remained stagnant or decreased. Further research is needed to understand the uptake of these treatment modalities and the unique abilities of the PHD to study specific device therapy in the VTE population.

PEERLESS II: A Randomized Controlled Trial of Large-Bore Thrombectomy Versus Anticoagulation in Intermediate-Risk Pulmonary Embolism.

Background: Anticoagulation (AC) is the guideline-recommended treatment for intermediate-risk pulmonary embolism (PE); however, it remains unclear whether mechanical thrombectomy provides benefit over AC alone. The PEERLESS II study aims to evaluate outcomes in intermediate-risk PE patients randomized to treatment with large-bore mechanical thrombectomy and AC vs AC alone. Methods: PEERLESS II is an international randomized controlled trial enrolling up to 1200 patients with intermediate-risk PE and additional clinical risk factors from up to 100 sites. Treatment is randomized 1:1 to large-bore mechanical thrombectomy with the FlowTriever System (Inari Medical) and AC or AC alone. Outcomes will be evaluated for up to 3 months, with safety events independently adjudicated. The primary end point is a hierarchical composite win ratio of (1) all-cause mortality by 30 days, (2) clinical deterioration (earlier of discharge or 30 days), (3) all-cause hospital readmission by 30 days, (4) bailout therapy (earlier of discharge or 30 days), and (5) Modified Medical Research Council (mMRC) dyspnea score of ≥1 at the 48-hour visit. Secondary end points include all-cause and PE-related mortality (30-day and 90-day), all-cause and PE-related readmission (30-day and 90-day), major bleeding (30-day and 90-day), clinical deterioration (earlier of discharge or 30 days), bailout (earlier of discharge or 30 days), right ventricle-to-left ventricle diameter ratio (48-hour visit), mMRC dyspnea score (48-hour, 1-month, and 3-month visits), quality of life using Pulmonary Embolism Quality of Life and EuroQol-5 Dimensions-5 Levels (1-month and 3-month visits), 6-minute walk distance (1-month visit), and post-PE impairment diagnosis (3-month visit). Conclusions: PEERLESS II will inform the understanding of mechanical thrombectomy treatment for intermediate-risk PE and provide evidence for consideration in future treatment guidelines.

Long-Term Outcomes in Patients With Chronic Total Occlusion.

Although a chronic total occlusion (CTO) in the setting of an acute coronary syndrome is associated with greater risk, the prognosis of patients with a CTO and stable coronary artery disease (CAD) remains unknown. This study aimed to investigate adverse event rates in patients with stable CAD with and without a CTO. In 3,597 patients with stable CAD (>50% coronary luminal stenosis) who underwent cardiac catheterization, all-cause mortality, cardiovascular mortality, and the composite major adverse cardiac event (MACE) rates for cardiovascular death, myocardial infarction, and heart failure hospitalization were evaluated. Cox proportional hazards and Fine and Gray subdistribution hazard models were used to compare event-free survival in patient subsets after adjustment for covariates. Event rates were higher in patients with CTOs than in those without CTOs after adjusting for demographic and clinical characteristics (cardiovascular death hazard ratio [HR] 1.29, 95% confidence interval [CI] 1.05 to 1.57, p = 0.012). Patients with CTO revascularization had lower event rates than those of patients without CTO revascularization (cardiovascular death HR 0.43, CI 0.26 to 0.70, p = 0.001). Those with nonrevascularized CTOs were at particularly great risk when compared with those without CTO (cardiovascular death HR 1.52, CI 1.25 to 1.84, p <0.001). Moreover, those with revascularized CTOs had similar event rates to those of patients with CAD without CTOs. Patients with CTO have higher rates of adverse cardiovascular events than those of patients with significant CAD without CTO. This risk is greatest in patients with nonrevascularized CTO.

Radiation Exposure Using Rampart vs Standard Lead Aprons and Shields During Invasive Cardiovascular Procedures.

Background: Radiation exposure during invasive cardiovascular procedures remains an important health care issue. Lead aprons and shields (LAS) are used to decrease radiation exposure but leave large portions of the body unshielded. The Rampart IC M1128 is a portable radiation shielding system that may significantly attenuate radiation exposure. Methods: Catheterization laboratory teams were randomized in a 1:1 fashion to perform elective invasive cardiovascular procedures utilizing either traditional LAS or the Rampart IC M1128. Radiation exposure was measured using real-time dosimetry monitoring in prespecified anatomic locations on 3 operators (position 1: first operator/fellow; position 2: second operator/attending; and position 3: catheterization laboratory nurse/technologist). Radiation exposure was measured on a per-case basis. Results: In total, 100 consecutive cases were randomized in this study (47 Rampart; 53 LAS). There was no difference in fluoroscopy time (12.3 minutes for Rampart vs 15.4 minutes for LAS; P = .52), dose area product (288 Gy⋅cm2 for Rampart vs 376.5 Gy⋅cm2 for LAS; P = .52), or scatter radiation (38.8 mRem for Rampart vs 46.8 mRem for LAS; P = .61) between the groups. There was significantly lower total body radiation (in milliroentgen equivalent man) exposure using the Rampart than that using LAS for each team member: position 1-0.1 mRem for Rampart vs 2.2 mRem for LAS; P < .001; position 2-0.1 mRem Rampart vs 3.2 mRem LAS; P < .001; and position 3-0.0 mRem for Rampart vs 0.8 mRem for LAS; P < .001. Conclusions: During routine clinical procedures, the Rampart system significantly decreases total body radiation exposure compared with traditional LAS.

Restenosis rates for drug-eluting stents used in treating small vessel cardiac allograft vasculopathy after orthotopic heart transplantation.

BACKGROUND: Cardiac allograft vasculopathy (CAV) is associated with increased mortality in patients with orthotopic heart transplantation (OHT). In addition to immunosuppression, CAV can be treated with percutaneous coronary intervention (PCI) with drug eluting stents (DES) for focal lesions. There is a paucity of data on the rate of DES restenosis in patients with small vessel CAV. METHODS: This was a retrospective observational study of 101 coronary vessels treated with a DES diameter of 2.5 mm or less (small vessels) in 61 OHT patients compared to 72 coronary vessels treated with a DES diameter of >2.5 mm (large vessels) in 44 OHT patients at a single center between 2004 and 2022. Baseline demographic data, angiographic characteristics, and clinical outcomes were analyzed. RESULTS: At an average of 1.6 years after DES placement, follow-up angiography revealed in-stent restenosis in 36 (39 %) small vessel interventions and 11 (17 %) large vessel interventions (p = 0.003). Long term mortality did not differ between the groups (59 % vs 59 % at a median of 4.7 [IQR 2.4-7.8] years follow up). CONCLUSION: DES restenosis rates are high in small vessel CAV. Additional studies specifically examining PCI in small vessel CAV as well as the potential role for newer treatment strategies for CAV are warranted.

N terminal pro-brain natriuretic peptide level and benefits of chronic total occlusion revascularization.

BACKGROUND: The management of revascularization of chronic total occlusions (CTOs) remains controversial. Whether specific patients gain survival benefit from CTO revascularization remains unknown. OBJECTIVES: We investigated whether (i) patients with CTO have higher N terminal pro-brain natriuretic peptide (NT pro-BNP) levels than patients without CTO, (ii) in patients with CTO, NT pro-BNP levels predict adverse events, and (iii) those with elevated levels benefit from revascularization. METHODS: In 392 patients with stable, significant coronary artery disease (CAD) and CTO undergoing coronary angiography, rates of all-cause mortality, cardiovascular death, and a composite (cardiovascular death, myocardial infarction and heart failure hospitalizations) were investigated. Unadjusted and adjusted Cox proportional and Fine and Gray sub-distribution hazard models were performed to determine the association between NT pro-BNP levels and incident event rates in patients with CTO. RESULTS: NT pro-BNP levels were higher in patients with, compared to those without CTO (median 230.0 vs. 177.7 pg/mL, p ≤0.001). Every doubling of NT pro-BNP level in patients with CTO was associated with a > 25% higher rate of adverse events. 111 (28.5%) patients underwent CTO revascularization. In patients with elevated NT pro-BNP levels (> 125 pg/mL), those who underwent CTO revascularization had substantially lower adverse event rates compared to patients without CTO revascularization (adjusted cardiovascular death hazard ratio 0.29, 95% confidence interval (0.09-0.88). However, in patients with low NT pro-BNP levels (≤ 125 pg/mL), event rates were similar in those with and without CTO revascularization. CONCLUSION: NT pro-BNP levels can help identify individuals who may benefit from CTO revascularization.

Circulating Progenitor Cells and Coronary Collaterals in Chronic Total Occlusion.

BACKGROUND: The role of circulating progenitor cells (CPC) in collateral formation that occurs in the presence of chronic total occlusions (CTO) of a coronary artery is not well established. In stable patients with a CTO, we investigated whether CPC levels are associated with (a) collateral development and (b) ischemic burden, as measured by circulating high sensitivity troponin-I (hsTn-I) levels. METHODS: CPCs were enumerated by flow cytometry as CD45med+ blood mononuclear cells expressing CD34 and both CD34 and CD133 epitopes. The association between CPC counts and both Rentrop collateral grade (0, 1, 2, or 3) and hsTn-I levels were evaluated using multivariate regression analysis, after adjusting for demographic and clinical characteristics. RESULTS: In 89 patients (age 65.5, 72% male, 27% Black), a higher CPC count was positively associated with a higher Rentrop collateral grade; [CD34+ adjusted odds ratio (OR) 1.49 95% confidence interval (CI) (0.95, 2.34) P = 0.082] and [CD34+/CD133+ OR 1.57 95% CI (1.05, 2.36) P = 0.028]. Every doubling of CPC counts was also associated with lower hsTn-I levels [CD34+ ß -0.35 95% CI (-0.49, -0.15) P = 0.002] and [CD34+/CD133+ ß -0.27 95% CI (-0.43, -0.08) P = 0.009] after adjustment. CONCLUSION: Individuals with higher CPC counts have greater collateral development and lower ischemic burden in the presence of a CTO.

Mechanical Thrombectomy for High-Risk Pulmonary Embolism: Insights From the US Cohort of the FLASH Registry.

Background: Acute mortality for high-risk, or massive, pulmonary embolism (PE) is almost 30% even when treated using advanced therapies. This analysis assessed the safety and effectiveness of mechanical thrombectomy (MT) for high-risk PE. Methods: The prospective, multicenter FlowTriever All-comer Registry for Patient Safety and Hemodynamics (FLASH) study is designed to evaluate real-world PE patient outcomes after MT with the FlowTriever System (Inari Medical). In this study, acute outcomes through 30 days were evaluated for the subset of patients with high-risk PE as determined by the sites and following European Society of Cardiology guidelines. An independent medical monitor adjudicated adverse events (AEs), including major AEs: device-related mortality, major bleeding, or intraprocedural device-related or procedure-related AEs. Results: Of the 799 patients in the US cohort, 63 (7.9%) were diagnosed with high-risk PE; 30 (47.6%) patients showed a systolic blood pressure <90 mm Hg, 29 (46.0%) required vasopressors, and 4 (6.3%) experienced cardiac arrest. The mean age of patients with high-risk PE was 59.4 ± 15.6 years, and 34 (54.0%) were women. At baseline, 45 (72.6%) patients were tachycardic, 18 (54.5%) showed elevated lactate levels of ≥2.5 mM, and 21 (42.9%) demonstrated depressed cardiac index of <2 L/min/m2. Immediately after MT, heart rate improved to 93.5 ± 17.9 bpm. Twenty-five (42.4%) patients did not require an overnight stay in the intensive care unit, and no mortalities or major AEs occurred through 48 hours. Moreover, no mortalities occurred in 61 (96.8%) patients followed up through the 30-day visit. Conclusions: In this cohort of 63 patients with high-risk PE, MT was safe and effective, with no acute mortalities reported. Further prospective data are needed in this population.

Pathogenesis, Diagnosis, and Management of Chronic Thromboembolic Pulmonary Hypertension.

Chronic thromboembolic pulmonary hypertension (CTEPH) is thought to occur as a sequelae of thromboembolic processes in the pulmonary vasculature. The pathophysiology of CTEPH is multifactorial, including impaired fibrinolysis, endothelial dysregulation, and hypoxic adaptations. The diagnosis of CTEPH is typically delayed considering the nonspecific nature of the symptoms, lack of screening, and relatively low incidence. Diagnostic tools include ventilation-perfusion testing, echocardiography, cardiac catheterization, and pulmonary angiography. The only potentially curative treatment for CTEPH is pulmonary endarterectomy However, approximately 40% of patients are inoperable. Currently, only Riociguat is Food and Drug Administration approved specifically for CTEPH, with additional drug trials underway.

Incidence of Mortality and Complications in High-Risk Pulmonary Embolism: A Systematic Review and Meta-Analysis.

Background: The relationship between the early hemodynamic consequences of acute pulmonary embolism (PE) and short-term morbidity and mortality has long been recognized. The mortality incidence and other complications after high-risk (massive) PE, the most severe category of the disease, are summarized in this meta-analysis. Methods: A systematic review and meta-analysis of studies reporting on patients with massive PE indexed by PubMed and the Cochrane Library over a 10-year period (2010-2020) was conducted. Studies with adequate information to specify a cohort of patients with high-risk PE defined by the American Heart Association and European Society of Cardiology criteria and their clinical outcomes were included. Incidences were calculated as weighted averages with 95% CIs. Results: A total of 27 publications spanning 1517 patients were identified that met the search criteria for high-risk PE. In-hospital all-cause mortality averaged 28.3% (95% CI, 20.9%-37.0%) in patients at high risk, comparable to the 30-day all-cause mortality of 30.2% (95% CI, 22.3%-39.6%). In-hospital major bleeding was 13.8% (95% CI, 9.3%-20.0%), and intracranial hemorrhage was reported in 3.6% (95% CI, 2.2%-5.9%). The risk of bias in publications was graded as low-to-moderate, with substantial heterogeneity among the studies. Conclusions: This systematic review and meta-analysis provided low-quality to moderate-quality evidence documenting mortality, major bleeding, and other complications in patients meeting the American Heart Association and European Society of Cardiology criteria for high-risk PE. This information was used to inform the design of the FLowTriever for Acute Massive Pulmonary Embolism (FLAME) study (NCT04795167), a study evaluating an advanced therapy for patients with high-risk PE.