Stent imaging on a clinical dual-source photon-counting detector CT system-impact of luminal attenuation and sharp kernels on lumen visibility.

OBJECTIVES: To assess the impact of scan modes and reconstruction kernels using a novel dual-source photon-counting detector CT (PCD-CT) on lumen visibility and sharpness of different stent sizes. METHODS: A phantom containing six balloon-expandable stents (2.5 to 9 mm diameter) in silicone tubing was scanned on a PCD-CT with standard (0.6 mm and 0.4 mm thicknesses) and ultra-high-resolution (0.2 mm thickness) modes. With the use of increasing contrast medium concentrations, densities of 0, 200, 400, and 600 HU were achieved. Standard-resolution scans were reconstructed using increasing sharpness kernels, using both polyenergetic quantitative soft tissue "conventional" ((Qr40c(0.6 mm), Qr40c(0.4 mm), Qr72c(0.2 mm)) and vascular (Bv) virtual monoenergetic reconstructions (Bv44m(0.4 mm), Bv60m(0.4 mm)) at 70 keV. In-stent lumen visibility, sharpness (max. ΔHU of the stent measured in profile plots), and in-stent noise (standard deviation of HU) were measured. RESULTS: In-stent lumen visibility was highest for Qr72c(0.2 mm) (86.5 ± 2.8% to 88.3 ± 2.6%) and in Bv60m(0.4 mm) reconstructions (77.3 ± 2.9 to 82.7 ± 2.5%). Lumen visibility was lowest in the smallest stent (2.5 mm) ranging from 54.1% in Qr40c(0.6 mm) to 74.1% in Qr72c(0.2 mm) and highest in the largest stent (9 mm) ranging from 93.8% in Qr40c(0.6 mm) to 99.1% in the Qr72c(0.2 mm) series. Lumen visibility decreased by 2.1% for every 200-HU increase in lumen attenuation. Max. ΔHU between stents and stent lumen was highest in Qr72c(0.2 mm) (ΔHU 892 ± 504 to 1526 ± 517) and Bv60m(0.4 mm) series (ΔHU 480 ± 357 to 1030 ± 344). Improvement of lumen visibility and sharpness in UHR and Bv60m(0.4 mm) series was strongest in smaller stent sizes. CONCLUSION: UHR acquisition mode and sharp reconstruction kernels on a novel PCD-CT system significantly improve in-stent lumen visibility and sharpness-especially for smaller stent sizes. KEY POINTS: • In-stent lumen visibility and sharpness of stents significantly improve using sharp reconstruction kernels (Bv60) and ultra-high-resolution mode in photon-counting detector computed tomography. • The observed improvement of stent-lumen visibility was highest in smaller stent sizes.

Patient and limb outcomes 10 years after endovascular revascularization of the superficial femoral artery for peripheral artery disease: The Boston Femoral Artery Endovascular Revascularization Outcomes (Boston FAROUT) study.

BACKGROUND: We aimed to describe patient and limb outcomes in the decade after endovascular revascularization for chronic lower-extremity peripheral artery disease (PAD). METHODS: We assessed outcomes in patients having endovascular revascularization of the superficial femoral artery in two centers between 2003 and 2011 and followed for a median 9.3 (25-75%: 6.8, 11.1) years. Outcomes included death, myocardial infarction, stroke, repeat limb revascularizations, and amputations. We used competing risks analysis with clustering by patient to determine the hazard ratios (HR) and 95% CI for patients, and procedural characteristics for cause of death, cardiovascular events, and major adverse limb events (MALE). RESULTS: There were 253 index limb revascularizations in 202 patients followed for a median 9.3 years. Patients had intensive medical treatment with 90% on statins and 80% on beta-blockers. During follow up there were 57 (28%) cardiovascular deaths and 62 (31%) noncardiovascular deaths. Of the 253 limbs, 227 (90%) were free of MALE over follow up and 93 (37%) had MALE or minor repeat revascularization. In multivariable models, cardiovascular death significantly associated with critical limb ischemia (HR = 3.21, 95% CI = 1.84, 5.61) and noncardiovascular death with chronic kidney disease (HR = 2.69, 95% CI = 1.68, 4.30), and smoking (HR = 2.75, 95% CI = 1.01, 7.52). MALE or minor repeat revascularization associated with critical limb ischemia (HR = 1.43, 95% CI = 0.84, 2.43), smoking (HR = 2.49, 95% CI = 1.26, 4.90), and lesion length > 200 mm (HR = 1.51, 95% CI = 0.98, 2.33). CONCLUSIONS: Among patients with intensive medical therapy, the risk of noncardiovascular death was high and similar to cardiovascular death. Endovascular intervention can have acceptable long-term results. Future studies should evaluate strategies to reduce both cardiovascular and noncardiovascular deaths.

Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial.

Importance: Two initial sham-controlled trials demonstrated that ultrasound renal denervation decreases blood pressure (BP) in patients with mild to moderate hypertension and hypertension that is resistant to treatment. Objective: To study the efficacy and safety of ultrasound renal denervation without the confounding influence of antihypertensive medications in patients with hypertension. Design, Setting, and Participants: Sham-controlled, randomized clinical trial with patients and outcome assessors blinded to treatment assignment that was conducted between January 14, 2019, and March 25, 2022, at 37 centers in the US and 24 centers in Europe, with randomization stratified by center. Patients aged 18 years to 75 years with hypertension (seated office systolic BP [SBP] ≥140 mm Hg and diastolic BP [DBP] ≥90 mm Hg despite taking up to 2 antihypertensive medications) were eligible if they had an ambulatory SBP/DBP of 135/85 mm Hg or greater and an SBP/DBP less than 170/105 mm Hg after a 4-week washout of their medications. Patients with an estimated glomerular filtration rate of 40 mL/min/1.73 m2 or greater and with suitable renal artery anatomy were randomized 2:1 to undergo ultrasound renal denervation or a sham procedure. Patients were to abstain from antihypertensive medications until the 2-month follow-up unless prespecified BP criteria were exceeded and were associated with clinical symptoms. Interventions: Ultrasound renal denervation vs a sham procedure. Main Outcomes and Measures: The primary efficacy outcome was the mean change in daytime ambulatory SBP at 2 months. The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular, and hypertensive events at 30 days and renal artery stenosis greater than 70% detected at 6 months. The secondary outcomes included mean change in 24-hour ambulatory SBP, home SBP, office SBP, and all DBP parameters at 2 months. Results: Among 1038 eligible patients, 150 were randomized to ultrasound renal denervation and 74 to a sham procedure (mean age, 55 years [SD, 9.3 years]; 28.6% female; and 16.1% self-identified as Black or African American). The reduction in daytime ambulatory SBP was greater with ultrasound renal denervation (mean, -7.9 mm Hg [SD, 11.6 mm Hg]) vs the sham procedure (mean, -1.8 mm Hg [SD, 9.5 mm Hg]) (baseline-adjusted between-group difference, -6.3 mm Hg [95% CI, -9.3 to -3.2 mm Hg], P < .001), with a consistent effect of ultrasound renal denervation throughout the 24-hour circadian cycle. Among 7 secondary BP outcomes, 6 were significantly improved with ultrasound renal denervation vs the sham procedure. No major adverse events were reported in either group. Conclusions and Relevance: In patients with hypertension, ultrasound renal denervation reduced daytime ambulatory SBP at 2 months in the absence of antihypertensive medications vs a sham procedure without postprocedural major adverse events. Trial Registration: ClinicalTrials.gov Identifier: NCT03614260.

Quiescent-Interval Slice-Selective MRA Accurately Estimates Intravascular Stent Dimensions Prior to Intervention in Patients With Peripheral Artery Disease.

BACKGROUND: Quiescent-interval slice-selective (QISS) magnetic resonance angiography (MRA) is a non-contrast alternative for the pre-procedural assessment of patients with peripheral artery disease (PAD). However, the feasibility of pre-procedural stent size estimation using QISS MRA would merit investigation. PURPOSE: To evaluate the feasibility of QISS MRA for pre-procedural stent size estimation in PAD patients compared to computed tomography angiography (CTA). STUDY TYPE: Retrospective. SUBJECTS: Thirty-three PAD patients (68 ± 9 years, 18 men, 15 women). FIELD STRENGTH/SEQUENCE: Two-dimensional balanced steady-state free precession QISS MRA at 1.5 T and 3 T. ASSESSMENT: All patients received QISS MRA and CTA of the lower extremity run-off followed by interventional digital subtraction angiography (DSA). Stenotic lesion length and diameter were quantified (AMF and AVS with 3 and 13 years of experience in cardiovascular imaging, respectively) to estimate the dimensions of the stent necessary to restore blood flow in the treated arteries. Measured dimensions were adjusted to the closest stent size available. STATISTICAL TESTS: The Friedman test with subsequent pairwise Wilcoxon signed-rank test was used to compare the estimated stent dimensions between QISS MRA, CTA, and the physical stent size used for intervention. Intra-class correlation (ICC) analysis was performed to assess inter-reader agreement. Significant differences were considered at P < 0.05. RESULTS: No significant difference was observed between estimated stent diameter by QISS MRA or CTA compared to physical stent diameter (8.9 ± 2.9 mm, 8.8 ± 3.0 mm, and 8.8 ± 3.8 mm, respectively; χ2  = 1.45, P = 0.483). There was a significant underestimation of stent length for both QISS MRA and CTA, compared to physical stent length (45.8 ± 27.8 mm, 46.4 ± 29.3 mm, and 50.4 ± 34.0 mm, respectively; χ2  = 11.96) which could be corrected when measurements were adjusted to the next available stent length (χ2  = 2.38, P = 0.303). Inter-reader assessment showed good to excellent agreement between the readers (all ICC ≥0.81). DATA CONCLUSION: QISS MRA represents a reliable method for pre-procedural lesion assessment and stent diameter and length estimation in PAD patients. LEVEL OF EVIDENCE: 3 TECHNICAL EFFICACY: Stage 2.

Diagnostic accuracy of non-contrast quiescent-interval slice-selective (QISS) MRA combined with MRI-based vascular calcification visualization for the assessment of arterial stenosis in patients with lower extremity peripheral artery disease.

OBJECTIVES: The proton density-weighted, in-phase stack-of-stars (PDIP-SOS) MRI technique provides calcification visualization in peripheral artery disease (PAD). This study sought to investigate the diagnostic accuracy of a combined non-contrast quiescent-interval slice-selective (QISS) MRA and PDIP-SOS MRI protocol for the detection of PAD, in comparison with CTA and digital subtraction angiography (DSA). METHODS: Twenty-six prospectively enrolled PAD patients (70 ± 8 years) underwent lower extremity CTA and 1.5-T or 3-T PDIP-SOS/QISS MRI prior to DSA. Two readers rated image quality and graded stenosis (≥ 50%) on QISS MRA without/with calcification visualization. Sensitivity, specificity, and area under the curve (AUC) were calculated against DSA. Calcification was quantified and compared between MRI and non-contrast CT (NCCT) using paired t test, Pearson's correlation, and Bland-Altman analysis. RESULTS: Image quality ratings were significantly higher for CTA compared to those for MRA (4.0 [3.0-4.0] and 3.0 [3.0-4.0]; p = 0.0369). The sensitivity and specificity of QISS MRA, QISS MRA with PDIP-SOS, and CTA for ≥ 50% stenosis detection were 85.4%, 92.2%, and 90.2%, and 90.3%, 93.2%, and 94.2%, respectively, while AUCs were 0.879, 0.928, and 0.923, respectively. A significant increase in AUC was observed when PDIP-SOS was added to the MRA protocol (p = 0.0266). Quantification of calcification showed significant differences between PDIP-SOS and NCCT (80.6 ± 31.2 mm3 vs. 88.0 ± 29.8 mm3; p = 0.0002) with high correlation (r = 0.77, p < 0.0001) and moderate mean of differences (- 7.4 mm3). CONCLUSION: QISS MRA combined with PDIP-SOS MRI provides improved, CTA equivalent, accuracy for the detection of PAD, although its image quality remains inferior to CTA. KEY POINTS: • Agreement in stenosis detection rate using non-contrast quiescent-interval slice-selective MRA compared to DSA improved when calcification visualization was provided to the readers. • An increase was observed in both sensitivity and specificity for the detection of ≥ 50% stenosis when MRI-based calcification assessment was added to the protocol, resulting in a diagnostic accuracy more comparable to CTA. • Quantification of calcification showed statistical difference between MRI and non-contrast CT; however, a high correlation was observed between the techniques.

Aggressive Therapy for Acute Pulmonary Embolism: Systemic Thrombolysis and Catheter-Directed Approaches.

Venous thromboembolism (VTE) is the third most common cause of cardiovascular disease after myocardial infarction and stroke. Population-based studies estimate that up to 94,000 new cases of pulmonary embolism (PE) occur in the United States annually with an increasing incidence with age. Mortality from PE is the greatest in the first 24 hours, with a decreased survival extending out 3 months. Thus, acute PE is a potentially fatal illness if not recognized and treated in a timely manner. Contemporary management includes systemic anticoagulation, thrombolysis, catheter-based procedures, and surgical embolectomy. This article reviews current clinical evidence and societal guidelines for the use of systemic and catheter-directed thrombolysis for treatment of acute PE.

Comparison of 2D and 3D quiescent-interval slice-selective non-contrast MR angiography in patients with peripheral artery disease.

OBJECTIVE: To evaluate the potential clinical benefit of the superior spatial resolution of 3D prototype thin-slab stack-of-stars (tsSOS) quiescent-interval slice-selective (QISS) MRA over standard 2D-QISS MRA for the detection peripheral artery disease (PAD), using computed tomography angiography (CTA) as reference. MATERIALS AND METHODS: Twenty-three patients (70 ± 8 years, 18 men) with PAD who had previously undergone run-off CTA were prospectively enrolled. Patients underwent non-contrast MRA using 2D-QISS and tsSOS-QISS at 1.5 T. Eighteen arterial segments were evaluated for subjective and objective image quality (normalized signal-to-noise, nSNR), vessel sharpness, and area under the curve (AUC) for > 50% stenosis detection. RESULTS: Overall subjective image quality ratings for the entire run-off were not different between tsSOS-QISS and 2D-QISS (3 [3; 4] vs 4 [3; 4], respectively; P = 0.813). Sharpness of primary branch vessels demonstrated improved image quality using tsSOS-QISS compared with 2D-QISS (4 [3; 4] vs 3 [2; 3], P = 0.008). Objective image quality measures were not different between 2D-QISS and tsSOS-QISS (nSNR 5.0 ± 1.9 vs 4.2 ± 1.8; P = 0.132). AUCs for significant stenosis detection by tsSOS-QISS and 2D-QISS were 0.877 and 0.856, respectively (P = 0.336). DISCUSSION: The prototype 3D tsSOS-QISS technique provides similar accuracy in patients with PAD to a standard commercially available 2D-QISS technique, indicating that the use of relatively thick slices does not limit the diagnostic performance of 2D-QISS. However, subjective image quality for branch vessel depiction is improved using the 3D approach.

Rate of major adverse renal or cardiac events with iohexol compared to other low osmolar contrast media during interventional cardiovascular procedures.

OBJECTIVE: This study assessed the rate of major adverse renal or cardiac events (MARCE) when iohexol is used during interventional cardiovascular procedures compared to other low osmolar contrast media (LOCMs). BACKGROUND: Interventional cardiovascular procedures are often essential for diagnosis and treatment, the risk of MARCE should be considered. METHODS: Data were derived from the Premier Hospital Database January 1, 2010 through September 30, 2015. Patient encounters with an inpatient primary interventional cardiovascular procedure with a single LOCM (iohexol, ioversol, ioxilan, ioxaglate, or iopamidol) were included. The primary outcome was a composite endpoint of MARCE, which included: renal failure with dialysis, acute kidney injury (AKI) with or without dialysis, contrast induced AKI, acute myocardial infarction, angina, stent occlusion/thrombosis, stroke, transient ischemic attack, or death. Multivariable regression analysis was performed using the hospital fixed-effects specification to assess the relationship between MARCE and iohexol compared to other LOCMs, while controlling for patient demographics, comorbid conditions and reason for hospitalization. As a sensitivity analysis, direct comparisons of iohexol were made to other LOCMs. RESULTS: A total of 458,091 inpatient encounters met inclusion criteria of which 26% used iohexol and 74% used other LOCMs. Results of multivariable modeling revealed no differences in MARCE rates between iohexol and other LOCMs. When direct comparisons of iohexol vs. ioversol and iopamidol were modeled, no differences in MARCE nor the renal component of MARCE were found. CONCLUSIONS: In this retrospective multicenter study, there were no differences in MARCE events with iohexol compared to other LOCMs during inpatient interventional cardiovascular procedures.

Treatment of submassive and massive pulmonary embolism: a clinical practice survey from the second annual meeting of the Pulmonary Embolism Response Team Consortium.

There is a paucity of robust clinical trial data to guide the treatment of acute pulmonary embolism (PE) thus the clinical guidelines rely heavily on expert opinion. Pulmonary Embolism Response Teams (PERT) have been developed to streamline the care of patients with acute PE. We conducted a survey among 100 experts in the field of PE during the second annual meeting of the PERT Consortium. Respondents were queried with respect to their demographic information, clinical practice questions and clinical vignettes. Clinical practice questions were focused questions about the risk stratification and treatment of patients with acute submassive PE, anticoagulation strategies for patients receiving thrombolysis and the use of inferior vena cava filters. Clinical vignettes were designed to assess participants' preferred choice of treatment for a variety of commonly encountered clinical scenarios. Among physicians affiliated with a PERT, there is overall agreement with regards to the criteria used for risk classification of patients with PE and its application to patients in the provided clinical vignettes. In contrast, there is substantial variability in the treatment strategies of patients presenting with commonly encountered clinical scenarios. The results of this survey highlight the need for more clinical trial data along with accepted algorithms for treatment of acute PE. In the absence of this, PERTs can facilitate multidisciplinary discussions in order to standardize treatment and provide evidence-based therapies to patients with acute PE.

A noise-optimized virtual monochromatic reconstruction algorithm improves stent visualization and diagnostic accuracy for detection of in-stent re-stenosis in lower extremity run-off CT angiography.

PURPOSE: To evaluate the impact of noise-optimized virtual monochromatic imaging (VMI+) on stent visualization and accuracy for in-stent re-stenosis at lower extremity dual-energy CT angiography (DE-CTA). MATERIAL AND METHODS: We evaluated third-generation dual-source DE-CTA studies in 31 patients with prior stent placement. Images were reconstructed with linear blending (F_0.5) and VMI+ at 40-150 keV. In-stent luminal diameter was measured and contrast-to-noise ratio (CNR) calculated. Diagnostic confidence was determined using a five-point scale. In 21 patients with invasive catheter angiography, accuracy for significant re-stenosis (≥50 %) was assessed at F_0.5 and 80 keV-VMI+ chosen as the optimal energy level based on image-quality analysis. RESULTS: At CTA, 45 stents were present. DSA was available for 28 stents whereas 12 stents showed significant re-stenosis. CNR was significantly higher with ≤80 keV-VMI+ (17.9 ± 6.4-33.7 ± 12.3) compared to F_0.5 (16.9 ± 4.8; all p < 0.0463); luminal stent diameters were increased at ≥70 keV (5.41 ± 1.8-5.92 ± 1.7 vs. 5.27 ± 1.8, all p < 0.001) and diagnostic confidence was highest at 70-80 keV-VMI+ (4.90 ± 0.48-4.88 ± 0.63 vs. 4.60 ± 0.66, p = 0.001, 0.0042). Sensitivity, negative predictive value and accuracy for re-stenosis were higher with 80 keV-VMI+ (100, 100, 96.4 %) than F_0.5 (90.9, 94.1, 89.3 %). CONCLUSION: 80 keV-VMI+ improves image quality, diagnostic confidence and accuracy for stent evaluation at lower extremity DE-CTA. KEY POINTS: • The impact of noise-optimized virtual monochromatic imaging on stent visualization was assessed. • Virtual monochromatic imaging significantly improves stent lumen visualization and diagnostic confidence. • At 80 keV diagnostic performance for detection of in-stent restenosis was increased. • 80 keV virtual monochromatic images are recommended for stent evaluation of lower extremity vasculature.

Modelling costs of interventional pulmonary embolism treatment: implications of US trends for a European healthcare system.

AIMS: Catheter-directed treatment (CDT) of acute pulmonary embolism (PE) is entering a growth phase in Europe following a steady increase in the USA in the past decade, but the potential economic impact on European healthcare systems remains unknown. METHODS AND RESULTS: We built two statistical models for the monthly trend of proportion of CDT among patients with severe (intermediate- or high-risk) PE in the USA. The conservative model was based on admission data from the National Inpatient Sample (NIS) 2016-20 and the model reflecting increasing access to advanced treatment from the PERT™ national quality assurance database registry 2018-21. By applying these models to the forecast of annual PE-related hospitalizations in Germany, we calculated the annual number of severe PE cases and the expected increase in CDT use for the period 2025-30. The NIS-based model yielded a slow increase, reaching 3.1% (95% confidence interval 3.0-3.2%) among all hospitalizations with PE in 2030; in the PERT-based model, increase would be steeper, reaching 8.7% (8.3-9.2%). Based on current reimbursement rates, we estimated an increase of annual costs for PE-related hospitalizations in Germany ranging from 15.3 to 49.8 million euros by 2030. This calculation does not account for potential cost savings, including those from reduced length of hospital stay. CONCLUSION: Our approach and results, which may be adapted to other European healthcare systems, provide a benchmark for healthcare costs expected to result from CDT. Data from ongoing trials on clinical benefits and cost savings are needed to determine cost-effectiveness and inform reimbursement decisions.

Alcohol septal ablation for obstructive hypertrophic cardiomyopathy: outcomes in young, middle-aged, and elderly patients.

OBJECTIVES: We compared the efficacy and safety of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) in young, middle-aged, and elderly patients. BACKGROUND: Intersociety guidelines suggest based on limited evidence that young patients with medically refractory symptoms of obstructive HCM should undergo surgical myectomy while elderly patients may be more appropriate for ASA. METHODS: Data for 360 patients undergoing 389 ASAs were prospectively collected and retrospectively analyzed according to age. RESULTS: Young (<45 years), middle-aged (45-64 years), and elderly (≥65 years) patients comprised 28, 40, and 32% of the study population, respectively. Young patients had thicker left ventricular septal walls at baseline, and elderly patients had more comorbidity and dyspnea. Resting, mean left ventricular outflow tract gradients (LVOTGs) were similar across the age groups at baseline (62, 66, and 68 mm Hg, respectively; P = NS for all comparisons). LVOTGs and dyspnea were significantly and similarly improved in all age groups immediately after ASA and through 12 months of follow-up (P < 0.001 for before and after comparisons; P = NS for intergroup comparisons). Complication rates were similar for young and middle-aged patients but higher for elderly patients (9.1 and 6.3% vs. 20.8%, respectively; P ≤ 0.016 for elderly vs. others). Mortality rates for young and middle-aged patients were lower than for elderly patients, but the differences were not statistically significant. CONCLUSIONS: Patients undergoing ASA had significant and similar improvements in LVOTGs and symptoms regardless of age. Procedural complications were increased in elderly patients, who had numerically but not statistically significantly higher mortality rates.

Neuromodulation device therapy for treatment of hypertensive heart disease.

Hypertensive heart disease (HHD) is the leading cause of mortality and morbidity in the United States. Despite the availability of medical therapy it remains a challenge to treat. Autonomic nervous system imbalance resulting in overactivity of the sympathetic nervous system and under activity of the parasympathetic nervous system is integral in the development of hypertension and ultimately the development of HHD. Emerging data suggest that neuromodulation device therapy for treatment of HHD is promising.

Risk of Mortality Related to Recurrent Limb Events After Endovascular Revascularization of the Superficial Femoral Artery for Peripheral Artery Disease: The Boston Femoral Artery Endovascular Revascularization Outcomes (Boston FAROUT) Study.

Endovascular revascularization of the superficial femoral artery (SFA) may lead to recurrent ischemic syndromes, revascularization, or amputation. The impact of these events on mortality is unknown. We followed all patients having SFA endovascular revascularization for claudication or chronic limb-threatening ischemia in 2 cardiovascular (CV) divisions in Boston, Massachusetts. Any recurrent limb event after the initial SFA revascularization included recurrent claudication (67%), limb ulceration or gangrene (13%), repeat endovascular revascularization (61%), surgical revascularization (15%), or major (9%) or minor amputation (8%). We linked data to the National Death Index to ascertain cause of death grouped into CV mortality, or non-CV mortality. Hazard ratios (HRs) and 95% confidence intervals (95% CIs) from Cox proportional hazards and sub-HRs from Fine-Gray competing risks analyses were clustered by patient. Overall, there were 202 patients with 253 index limb endovascular procedures. A recurrent limb event occurred in 123 limbs (49%) and 93 patients (46%). Patients with and without recurrent limb events had similar numbers of deaths over follow-up (76 [62%] vs 71 [55%], respectively). In multivariable models, recurrent limb event was not related to all-cause death (HR 0.92, 95% CI 0.64 to 1.33), CV death (HR 1.29, 95% CI 0.72 to 1.30), or non-CV death (HR 0.65, CI 0.39 to 1.07). Competing risk analyses suggested male gender and chronic limb-threatening ischemia were more strongly related to CV death, and chronic kidney more strongly related to disease to non-CV death. In conclusion, recurrent limb events, which contribute to patient morbidity, do not increase the risk of all-cause or cause-specific mortality, and should not discourage repeat revascularization to relieve symptoms or ischemia.

A Multimodality Imaging Approach to Defining Risk in Patients With Acute Pulmonary Embolism.

BACKGROUND: Morbidity and mortality for acute pulmonary embolism (PE) remain high. Therapies such as catheter-directed thrombolysis may improve outcomes, but these are generally reserved for higher-risk patients. Imaging may help guide the use of the newer therapies, but current guidelines focus more on clinical factors. Our goal was to create a risk model that incorporated quantitative echocardiographic and computed tomography (CT) measures of right ventricular (RV) size and function, thrombus burden, and serum biomarkers of cardiac overload or injury. METHODS: This was a retrospective study of 150 patients evaluated by a PE response team. Echocardiography was performed within 48 hours of diagnosis. Computed tomography measures included RV/left ventricular (LV) ratio and thrombus load (Qanadli score). Echocardiography was used to obtain various quantitative measures of RV function. We compared characteristics of those who met the primary endpoint (7-day mortality and clinical deterioration) to those who did not. Receiver operating curve analysis was used to assess the performance of different combinations of clinically relevant features and the association with adverse outcomes. RESULTS: Fifty-two percent of patients were female, with age 62 ± 17 years, systolic blood pressure 123 ± 25 mm Hg, heart rate 98 ± 19, troponin 3.2 ± 35 ng/dL, and b-type natriuretic peptide (BNP) 467 ± 653. Fourteen (9.3%) were treated with systemic thrombolytics, 27 (18%) underwent catheter-directed thrombolytics, 23 (15%) were intubated or required vasopressors, and 14 (9.3%) died. Patients who met the primary endpoint (44%) versus those who did not (56%) had lower RV S' (6.6 vs 11.9 cm/sec; P < .001) and RV free wall strain (-10.9% vs -13.6%; P = .005), higher RV/LV ratio on CT, and higher serum BNP and troponin levels. Receiver operating curve analysis demonstrated an area under the curve of 0.89 for a model that included RV S', RV free wall strain and tricuspid annular plane systolic excursion/RV systolic pressure ratio from echo, thrombus load and RV/LV ratio from CT, and troponin and BNP levels. CONCLUSION: A combination of clinical, echo, and CT findings that reflect the hemodynamic effects of the embolism identified patients with adverse events related to acute PE. Optimized scoring systems that focus on reversible abnormalities attributable to PE may allow more appropriate triaging of intermediate- to high-risk patients with PE for early interventional strategy.

Femoral artery percutaneous revascularization for patients with critical limb ischemia: outcomes compared to patients with claudication over 2.5 years.

Patients with critical limb ischemia have higher rates of death and amputation after revascularization compared to patients with intermittent claudication. However, the differences in patency after percutaneous revascularization of the superficial femoral artery are uncertain and impact the long-term risk of amputation and function in critical limb ischemia. We identified 171 limbs from 136 consecutive patients who had angioplasty and/or stenting for superficial femoral artery stenoses or occlusions from July 2003 through June 2007. Patients were followed for primary and secondary patency, death and amputation up to 2.5 years, and 111 claudicants were retrospectively compared to the 25 patients with critical limb ischemia. Successful percutaneous revascularization occurred in 128 of 142 limbs (90%) with claudication versus 25 of 29 limbs (86%) with critical limb ischemia (p = 0.51). Overall secondary patency at 2.5 years was 91% for claudication and 88% for critical limb ischemia. In Cox proportional hazards models, percutaneous revascularization for critical limb ischemia had similar long-term primary patency (adjusted hazard ratio = 1.1, 95% CI = 0.4, 2.6; p = 0.89) and secondary patency (adjusted hazard ratio = 1.1, 95% CI = 0.2, 6.0; p = 0.95) to revascularization for claudication. Patients with critical limb ischemia had higher mortality and death rates compared to claudicants, with prior statin use associated with less death (p = 0.034) and amputation (p = 0.010), and prior clopidogrel use associated with less amputation (p = 0.034). In conclusion, percutaneous superficial femoral artery revascularization is associated with similar long-term durability in both groups. Intensive treatment of atherosclerosis risk factors and surveillance for restenosis likely contribute to improving the long-term outcomes of both manifestations of peripheral artery disease.

Inari large-bore mechanical thrombectomy in intermediate-high risk submassive PE patients: Case series and literature review.

Pulmonary embolism (PE) is one of the most common causes of cardiovascular (CV) mortality worldwide. Owing to the associated morbidity and mortality with other treatment modalities, including systemic thrombolysis, a discernible change in the era of acute pulmonary embolism management has been reported. Catheter-directed thrombectomy using the FlowTriever system (Inari Medical; Irvine, CA, USA) was shown to reduce endpoints of interest in patients with acute intermediate-high risk PE and was associated with rapid hemodynamic improvement. In this report, we describe our experience with three cases of patients presenting with submassive PE, whereby immediate pulmonary artery pressure improvement was evident in all cases after successful mechanical thrombectomy. Our experience supports the use of FlowTriever mechanical thrombectomy for the treatment of submassive PE in clinical practice, with a call for further research to establish associated benefits.

Percutaneous revascularization of long femoral artery lesions for claudication: patency over 2.5 years and impact of systematic surveillance.

BACKGROUND: Angioplasty and stenting are preferred treatments for revascularizing femoral artery lesions up to 100 mm, but surgical bypass is recommended for longer lesions. We assessed long-term patency after percutaneous revascularization of long femoral artery lesions for claudication with intensive out-patient surveillance. METHODS: We followed a cohort of 111 consecutive patients receiving angioplasty or stenting in 142 limbs in two institutions. Patients were followed for 2.5 years, and event curves and multivariable survival analysis used to compare outcomes in three groups according to lesion length (< 100 mm, 100-200 mm, and greater than 200 mm). Failed patency was defined as recurrence of symptoms with a decline in ankle brachial index, or stenosis identified by duplex ultrasound, or reintervention. RESULTS: Compared to lesions less than 100 mm, longer lesions had higher failed primary patency (100-200 mm: HR = 2.0, P = 0.16, >200 mm: HR = 2.6, P = 0.03). Failed secondary patency was similar for short and intermediate lesions (< 5% incidence), but trended higher for lesions >200 mm (HR = 4.2, P = 0.06). An initial procedure residual stenosis greater than 20% was the only significant multivariable factor related to poorer long-term patency (HR = 15.8, P = 0.003). Compared to short lesions, the gain in long-term patency with out-patient surveillance and reintervention was higher for longer lesions and significantly so for intermediate lesions (100-200 mm = 23% versus <100 mm = 8%, P = 0.041). CONCLUSION: Percutaneous treatment of long femoral artery lesions can provide acceptable long-term patency for patients with claudication when out-patient surveillance is used to identify patients who require repeat interventions. Future long-term studies should consider overall patency encompassing more than one percutaneous reintervention.

Permanent inferior vena cava filters offer greater expected patient utility at lower predicted cost.

OBJECTIVE: Retrievable inferior vena cava (IVC) filters were first approved for use in the United States in 2003 to address the long-term complications of migration, thrombosis, fracture, and perforation observed with permanent IVC filter implantation. Although Food and Drug Administration approval of retrievable IVC filters includes permanent implantation, the incidence of complications from long-term implantation appears to be greater than that reported with existing permanent IVC filters. Also, only a small fraction of such retrievable IVC filters are ever retrieved. The purpose of the present study was to determine the threshold retrieval rate at which the use of retrievable IVC filters could be justified. METHODS: A Markov decision tree was constructed comparing retrievable and permanent IVC filters regarding their effectiveness and cost. A review of the reported data provided outcome probabilities, and the Tufts Medical Center Cost-Effectiveness Analysis Registry was the source of the utility values for the various potential outcomes. Medicare reimbursement rates served as a proxy for costs. A sensitivity analysis was performed for various parameters, primarily to determine the retrieval rate threshold at which the use of retrievable IVC filters would outperform the use of permanent IVC filters. RESULTS: Base case analysis demonstrated a greater predicted effectiveness for permanent compared with retrievable IVC filter implantation (5.41 quality-adjusted life-years [QALY] vs 5.33 QALY) at a lower cost ($2070 vs $4650). Monte Carlo simulation at 10,000 iterations confirmed the expected utility (5.4 ± 3.0 QALY vs 5.3 ± 3.0 QALY; P = .0002) and cost ($1900 ± $7400 vs $4800 ± 9900; P < .0001) to be statistically superior for permanent IVC filters. A sensitivity analysis for the filter retrieval rate demonstrated that the strategy of using a retrievable IVC filter was never preferable for utility or cost. The superiority of permanent IVC filter placement for effectiveness and cost persisted, regardless of anticipated patient-predicted annual mortality. A two-way sensitivity analysis for both IVC filter removal rate and annual patient mortality confirmed the superiority of permanent IVC filter placement at all levels. CONCLUSIONS: The predicted effectiveness of permanent IVC filters was greater and the predicted cost lower than those for retrievable IVC filters, regardless of the IVC filter retrieval rate. This interpretation of existing reported data using Markov decision analysis modeling supports the argument that unless the long-term complication rate of retrievable IVC filters can be significantly improved, their use should be abandoned in favor of currently available permanent IVC filters.

Comparison of 4 Acute Pulmonary Embolism Mortality Risk Scores in Patients Evaluated by Pulmonary Embolism Response Teams.

Importance: The risk of death from acute pulmonary embolism can range as high as 15%, depending on patient factors at initial presentation. Acute treatment decisions are largely based on an estimate of this mortality risk. Objective: To assess the performance of risk assessment scores in a modern, US cohort of patients with acute pulmonary embolism. Design, Setting, and Participants: This multicenter cohort study was conducted between October 2016 and October 2017 at 8 hospitals participating in the Pulmonary Embolism Response Team (PERT) Consortium registry. Included patients were adults who presented with acute pulmonary embolism and had sufficient information in the medical record to calculate risk scores. Data analysis was performed from March to May 2020. Main Outcomes and Measures: All-cause mortality (7- and 30-day) and associated discrimination were assessed by the area under the receiver operator curve (AUC). Results: Among 416 patients with acute pulmonary embolism (mean [SD] age, 61.3 [17.6] years; 207 men [49.8%]), 7-day mortality in the low-risk groups ranged from 1.3% (1 patient) to 3.1% (4 patients), whereas 30-day mortality ranged from 2.6% (1 patient) to 10.2% (13 patients). Among patients in the highest-risk groups, the 7-day mortality ranged from 7.0% (18 patients) to 16.3% (7 patients), whereas 30-day mortality ranged from 14.4% (37 patients) to 26.3% (26 patients). Each of the risk stratification tools had modest discrimination for 7-day mortality (AUC range, 0.616-0.666) with slightly lower discrimination for 30-day mortality (AUC range, 0.550-0.694). Conclusions and Relevance: These findings suggest that commonly used risk tools for acute pulmonary embolism have modest estimating ability. Future studies to develop and validate better risk assessment tools are needed.