Clinical Outcomes of Additional Below-The-Ankle Intervention Compared to Below-The-Knee Intervention Alone: A Post-Hoc Analysis of a Prospective Multicenter Study.

PURPOSE: To investigate the clinical implication of additional below-the-ankle (BTA) intervention in patients with chronic limb-threatening ischemia (CLTI) undergoing below-the-knee (BTK) intervention. MATERIALS AND METHODS: A sub-analysis was performed using data from the LIBERTY trial (ClinicalTrials.gov identifier NCT01855412), a prospective, observational, core-laboratory adjudicated, multicenter study of endovascular intervention in 1204 patients. Patients with CLTI (Rutherford Classification 4-6) who underwent BTK intervention were included in this sub-analysis. Participants were then stratified into 2 treatment groups according to whether at least one lesion intervened on was BTA (n=66) or not (n=273). The decision on whether and where to intervene was made during the procedure. The main outcome measures included major amputation, target vessel revascularization (TVR), major adverse events (MAE), survival, amputation-free survival, major adverse limb events or peri-operative death (MALE-POD), and all-cause death. Other outcome measures included procedural success, procedural complications, and wound healing rate. RESULTS: There were no differences in procedural success or severe angiographic complications between the 2 groups. At 1-year post-procedure, patients in the BTK group had a higher rate of freedom from major amputation (95.0% vs. 86.9%, respectively; HR: 2.87, 95% CI: 1.17-7.03), a higher rate of freedom from TVR (80.1% vs. 66.9%, respectively; HR: 1.94, 95% CI: 1.14-3.32), a higher rate of freedom from MALE-POD (94.6% vs. 86.9%, respectively; HR: 2.65, 95% CI: 1.10-6.41), and a higher rate of freedom from MAE at both 1 (76.0% vs. 60.1%, respectively; HR: 2.00, 95% CI: 1.24-3.22) and 3 years post procedure (67.5% vs. 55.8%, respectively; HR: 1.69, 95% CI: 1.08-2.65). There was a significantly lower rate of survival in the BTK group at 3 years (74.3% vs. 91.1%, respectively; HR: 0.35, 95% CI: 0.14-0.87). After risk adjustment, there was a higher rate of all-cause death in the BTK group at 3 years (19.4% vs. 9.1%, respectively; p=0.023) post-intervention. CONCLUSION: Patients with disease requiring intervention to BTA lesions have a potential increased amputation rate in the short term, but BTA intervention carries a potential survival benefit in the long term when compared to BTK intervention alone.

Residual SYNTAX II Score and long-term outcomes post-ST-elevation myocardial infarction in an urban US cohort: the Montefiore STEMI Registry.

BACKGROUND: Higher residual anatomic disease was associated with increased mortality in a recent randomized controlled trial of revascularization after ST-elevation myocardial infarction (STEMI). Less is known about the impact of residual disease post-STEMI in race-ethnic minorities. METHODS: Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX)- II (SS-II) score is an established scoring method for anatomic disease and prevalent co-morbidities to describe patient complexity. We evaluated residual (r) SS-II in 165 patients from a single center urban US registry (n = 1208) presenting for primary percutaneous coronary intervention of STEMI and treated for 3-vessel or left main and any combination of 0, 1, 2 or 3-vessel disease. RESULTS: The median age was 62 years (IQR 52-70), 29.1% women, 44.9% Hispanic/Latino and 19.4% non-Hispanic Black. Over median of 4.9 years (IQR 2.9-6.3), higher rSS-II was associated with increased death [hazard ratio 2.46 per SD increment in log rSS-II (~five-fold increment on the original scale) 95% CI 1.51, 3.99], death or all-cause readmission (hazard ratio 1.37 per SD increment in log rSS-II 95% CI, 1.11-1.70) and death or cardiovascular disease readmission (hazard ratio 1.46 per SD increment in log rSS-II 95% CI, 1.14-1.88). rSS-II was higher in older women with more co-morbidities, but not different by race-ethnicity. CONCLUSIONS: In summary, higher rSS-II was associated with long-term outcomes post-STEMI in a prospective urban, minority cohort, suggesting a potential role for risk stratification with this measure in a non-trial setting.

Transpedal approach for femoral-popliteal chronic total occlusions using the outback® elite re-entry device.

BACKGROUND: Transpedal access is increasingly utilized for the treatment of peripheral artery disease (PAD). Femoral-popliteal artery chronic total occlusions (CTOs) are some of the most difficult lesion subsets that sometimes require the use of re-entry support devices during percutaneous intervention. Limited data is available on the use of re-entry devices when treating femoral-popliteal CTOs via transpedal access. The aim of this study was to demonstrate the feasibility of using the Outback® Elite re-entry device for the treatment of femoral-popliteal CTOs via the transpedal approach in an outpatient based lab setting. METHODS: Seventeen patients presented with femoral-popliteal CTOs in which treatment required the use of the Outback® Elite re-entry device. All procedures were performed in a single outpatient based lab. Patients were followed at 1 week and 1 month post-procedure, with lower extremity arterial duplex ultrasound assessment during the 1 month follow-up. RESULTS: The average patient age was 78 years-old, with 71% being males. Most patients presented with Rutherford class IV symptoms. Procedural success was achieved in all patients with no requirement to convert to femoral artery access in any of the cases. No immediate post-procedural complications nor at any time during follow-up were observed. Ultrasonography at 1 month follow-up showed patent intervention sites and access site vessels in all patients. CONCLUSION: The use of the Outback® Elite re-entry device for the treatment of femoral-popliteal CTOs via transpedal access is a feasible option and may have potential benefits by avoiding risks associated with traditional femoral artery access.

Delayed Presentation of a Large Pseudoaneurysm in the Common Femoral Artery After an Electrophysiology Study.

We describe a rare case of an exceptionally large pseudoaneurysm that developed in the right common femoral artery 6 months after an electrophysiological study. Surgical and other conventional methods to treat his pseudoaneurysm were not feasible. Therefore, the pseudoaneurysm was successfully treated via an endovascular approach with a covered stent. (Level of Difficulty: Beginner.).

Treatment of an external iliac artery chronic total occlusion using alternate access sites.

BACKGROUND: With the advent of endovascular techniques, alternate sites such as the pedal and radial arteries can now be accessed when treating peripheral arterial disease to reduce procedural complications, shorten recovery time, and improve patient comfort. However, a paucity of literature exists on the availability of support devices that can be utilized during challenging cases. CASE PRESENTATION: A 70 year-old female patient presented for evaluation of severe lifestyle-limiting left-sided claudication refractory to maximal medical therapy. Angiography revealed a chronic total occlusion of the left external iliac artery, which was treated successfully by percutaneous intervention via a primary transpedal approach and with the assistance of the Outback® Elite re-entry device. The patient was discharged 2 h after the procedure and reported significant symptom improvement at follow-up. CONCLUSION: This case highlights a newly adopted endovascular approach through an alternate access site and illustrates how the Outback® Elite device can be used as an adjunctive tool in the treatment of complex lower-extremity vascular lesions.

The effect of nesiritide on renal function and other clinical parameters in patients with decompensated heart failure and preserved ejection fraction.

The role of nesiritide in patients with decompensated heart failure with preserved ejection fraction (dHFpEF) has not been previously studied. In this investigation, the authors retrospectively analyzed the effect of nesiritide on renal function and clinical outcomes in patients admitted with dHFpEF. Of the 658 patients included, 328 were treated with nesiritide while 330 patients were treated with standard diuretic therapy. In both the nesiritide and no nesiritide groups, there was a significant change in mean glomerular filtration rate (GFR) and creatinine at 72 hours as well as at day of discharge (P<.001). This trend did not progress at 1 month in the nesiritide group, although it did in the no nesiritide group. At 1 month after therapy, however, there was a significant difference between the two groups in the mean change of GFR and creatinine (P<.001). There was no significant difference in >25% decrease of GFR anytime through day 30 (25% vs 29.69%, P=.236) between the two groups. On multivariate analysis, nesiritide was an important predictor of renal function at 1 month (P<.05). Thus, nesiritide can be administered safely without negatively impacting long-term renal function in patients admitted with dHFpEF.