ORBIT II sub-analysis: Impact of impaired renal function following treatment of severely calcified coronary lesions with the Orbital Atherectomy System.

OBJECTIVES: To investigate the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare severely calcified lesions for stent deployment in patients grouped by renal function. BACKGROUND: Percutaneous coronary intervention (PCI) of severely calcified lesions is associated with increased rates of major adverse cardiac events (MACE), including death, myocardial infarction (MI), and target vessel revascularization (TVR) compared with PCI of non-calcified vessels. Patients with chronic kidney disease (CKD) are at increased risk for MACE after PCI. The impact of CKD on coronary orbital atherectomy treatment has not been well characterized. METHODS: ORBIT II was a prospective, multicenter trial in the U.S., which enrolled 443 patients with severely calcified coronary lesions. The MACE rate was defined as a composite of cardiac death, MI, and target vessel revascularization. RESULTS: Of the 441 patients enrolled with known estimated glomerular filtration rate (eGFR) values at baseline, 333 (75.5%) patients had eGFR < 90 ml/min/1.73 m2 and 108 patients had eGFR ≥ 90 ml/min/1.73 m2 . The mean eGFR at baseline in the eGFR < 90 ml/min/1.73 m2 and eGFR ≥ 90 ml/min/1.73 m2 groups was 65.0 ± 0.9 ml/min/1.73 m2 and 109.1 ± 2.0 ml/min/1.73 m2 , respectively. Freedom from MACE was lower in the eGFR < 90 ml/min/1.73 m2 group at 30 days (87.4% vs. 96.3%, P = 0.02) and 1-year (80.6% vs. 90.7%, P = 0.02). CONCLUSIONS: Patients with renal impairment had a higher MACE rate through one year follow-up due to a higher rate of periprocedural MI. Interestingly, the rates of cardiac death and revascularization through 1-year were similar in patients with eGFR < 90 ml/min/1.73 m2 and eGFR ≥ 90 ml/min/1.73 m2 . Future studies are needed to identify the ideal revascularization strategy for patients with renal impairment and severely calcified coronary lesions. © 2016 Wiley Periodicals, Inc.

Coronary revascularization strategy for ST elevation myocardial infarction with multivessel disease: experience and results at 1-year follow-up.

Primary percutaneous coronary intervention (PCI) of culprit lesions (CLs) is the standard of care in patients presenting with ST elevation myocardial infarction (STEMI). However, optimal revascularization strategy for significant nonculprit lesions (non-CLs) in the setting of STEMI remains controversial. The importance of defining of such a strategy lies in the fact that approximately 50% of patients with STEMI have multivessel disease (MVD). The aim of this study was to describe characteristics, therapeutic strategies, and 1-year outcomes in a cohort of patients with STEMI and MVD. We retrospectively analyzed a cohort of 63 patients with STEMI and MVD obtained from a 5-year catheterization database. MVD was defined as ≥70% stenosis of ≥2 epicardial coronary arteries. This cohort was followed for a period of 1 year for major adverse cardiac events (MACE was defined as acute coronary syndrome, new onset heart failure, or death) and all-cause mortality. PCI with stent placement was the major therapeutic procedure (87.5%) performed for CLs. Non-CLs did not undergo interventions in a majority of individuals (47.6%), while the remaining patients underwent PCI (29%) and coronary artery bypass graft surgery (22%) for non-CLs. At 1-year follow-up, prevalence of MACE events and death in the entire cohort were 30% and 15%, respectively. A trend for better outcomes (1-year cumulative MACE events but not mortality) was observed in CL-only intervention cohort compared with non-CL intervention. The PCI and Coronary artery bypass graft surgery cohorts did not show any significant difference in clinical outcomes. In this retrospective cohort of patients with MVD who presented with STEMI, no intervention of noncritical lesions was the prevalent approach, reflecting guideline recommendations. CL-only intervention strategy showed a better clinical outcome than non-CL intervention. Intervention of noncritical lesions therefore did not seem to improve MACEs or all-cause mortality at 1-year of follow-up and might in fact have had a detrimental effect on outcomes.

Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial.

OBJECTIVES: This study sought to prospectively evaluate the safety and efficacy of the Indigo aspiration system in submassive acute pulmonary embolism (PE). BACKGROUND: PE treatment with thrombolytics has bleeding risks. Aspiration thrombectomy can remove thrombus without thrombolytics, but data are lacking. METHODS: This study was a prospective, single-arm, multicenter study that enrolled patients with symptomatic acute PE ≤14 days, systolic blood pressure ≥90 mm Hg, and right ventricular-to-left ventricular (RV/LV) ratio >0.9. The primary efficacy endpoint was change in RV/LV ratio from baseline to 48 h post-procedure on core lab-adjudicated computed tomography angiography. The primary safety endpoint was a composite of 48-h major adverse events: device-related death, major bleeding, and device-related serious adverse events (clinical deterioration, pulmonary vascular, or cardiac injury). All sites received Institutional Review Board approval. RESULTS: A total of 119 patients (mean age 59.8 ± 15.0 years) were enrolled at 22 U.S. sites between November 2017 and March 2019. Median device insertion to removal time was 37.0 (interquartile range: 23.5 to 60.0) min. Two (1.7%) patients received intraprocedural thrombolytics. Mean RV/LV ratio reduction from baseline to 48 h post-procedure was 0.43 (95% confidence interval: 0.38 to 0.47; p < 0.0001). Two (1.7%) patients experienced 3 major adverse events. Rates of cardiac injury, pulmonary vascular injury, clinical deterioration, major bleeding, and device-related death at 48 h were 0%, 1.7%, 1.7%, 1.7%, and 0.8%, respectively. CONCLUSIONS: In this prospective, multicenter study the Indigo aspiration system was associated with a significant reduction in the RV/LV ratio and a low major adverse event rate in submassive PE patients. Intraprocedural thrombolytic drugs were avoided in 98.3% of patients. (Evaluating the Safety and Efficacy of the Indigo aspiration system in Acute Pulmonary Embolism [EXTRACT-PE]; NCT03218566).

A novel approach in the management of right-sided endocarditis: percutaneous vegectomy using the AngioVac cannula.

The AngioVac is a vacuum-based device introduced in 2012 to percutaneously remove undesirable material from the intravascular system. In scattered reports, the AngioVac has been used for removal of device-led vegetations and right-sided thrombi. In this article, we describe three cases of right-sided endocarditis treated with AngioVac: a mobile mass extending from the vena cava into the right atrium, large native tricuspid vegetations, and bioprosthetic tricuspid vegetations. This device shows benefit in reducing vegetation load, decreasing septic lung embolization, and reducing reinfection in active intravenous drug users. These cases exhibit the AngioVac's arrival as a new and exciting tool in endocarditis treatment, providing an alternative to open surgery and accessorizing antimicrobial treatment.

Successful management of acute massive pulmonary embolism using Angiovac suction catheter technique in a hemodynamically unstable patient.

Massive pulmonary embolism with hemodynamic instability is a life-threatening condition requiring immediate treatment. Urgent thrombectomy or thrombolysis is commonly used for the treatment of this condition. However, surgery is associated with high mortality rate and many patients have contraindications to thrombolytic therapy and are at high risk for bleeding. Cather-based intervention has gained increasing popularity particularly in patients with contraindication to thrombolytic therapy or at high risk for surgical thrombectomy. Catheter-based thrombus removal can be achieved by many means such as suction, fragmentation, extraction or rheolytic thrombectomy. We present a case of an elderly lady who suffered from acute massive pulmonary embolism with hemodynamic compromise successfully treated with AngioVac catheter system (AngioDynamics, Albany, NY) with full recovery.

Symptomatic radial artery thrombosis successfully treated with endovascular approach via femoral access route.

Radial access has been increasingly utilized for coronary intervention due to higher safety profile in comparison to femoral access site with lower bleeding rate. Radial artery occlusion is not uncommon with radial access site. This usually does not lead to any harm due to ulnar artery collaterals that are sufficient to prevent hand ischemia and is usually left alone. However, in the case of significant hand ischemia, treatment is often necessary. We are reporting an interesting case of symptomatic radial artery thrombosis leading to arm ischemia that was successfully treated percutaneously using femoral access. Using femoral access for radial artery intervention has not been reported previously. This case is followed by review of the literature.