Assessment of 2-Year Mortality With Use of Drug-Coated Devices in Femoropopliteal Disease: A Real-World Experience From the Bronx, New York.

The use of drug-coated devices (DCD) in peripheral arterial disease (PAD) intervention continues to remain controversial after a recent meta-analysis raised concerns of higher late mortality outcome with the use of these devices. Given this, there is need for more data with regards to the late mortality outcome with DCD use. We sought to assess the 2-year mortality outcome in patients with PAD treated with DCD in an inner-city public hospital that mainly serves patients of lower socio-economic status. METHODS: This was an observational study of consecutive patients with femoropopliteal arterial disease who had revascularization procedures from 2014 to 2018 at Jacobi Medical Center and were followed for 2 years. Patients were classified into DCD and non-drug-coated (nDCD) groups based on the device used at the index procedure. The primary endpoint was 2-year mortality. Propensity cohort matching was applied. A multivariate Cox regression model was used to identify baseline variables associated with 2-year mortality. RESULTS: 152 patients were included in this analysis (DCD group = 83, nDCD group =69). No significant difference in mortality between the two groups was identified at 2 years after propensity score matching with replacement (DCD: HR 0.72; 95% CI 0.30-1.71; p = 0.457). Patients that had revascularization because of intermittent claudication had lower mortality at 2 years compared to patients with critical limb ischemia as procedure indication (HR 0.18; 95% CI 0.04-0.82; p = 0.026). CONCLUSIONS: This propensity score matched study revealed no difference in 2-year mortality between patients treated with DCD compared to patients treated with nDCD.

Pulmonary Embolism Response Team (PERT) - A New Paradigm for the Treatment of Pulmonary Embolism.

Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. Patients with PE can present with a wide array of symptoms, ranging from mild to life threatening. The mainstay of PE treatment is anticoagulation; however, many advanced options are available for more severe patients, including catheter- directed interventions, surgical treatments, and hemodynamic support. Although different risk scores and clinical guidelines exist, the primary treating teams are frequently left uncertain on the most suitable treatment for a specific complex patient. Pulmonary Embolism Response Teams (PERT), composed of multidisciplinary experts, have emerged and been implemented in many centers and are available 24 hours a day to help guide the primary team. PERTs have changed the way complex PE patients are managed. In centers with a PERT, teams are called upon very frequently, and there is a significant increase in the use of advanced treatments for PE, although there are differences between centers based upon the center's specific PERT protocol and available capabilities. As PE is an evolving area, and more studies are necessary, PERTs around the world can help advance the field and improve the treatment offered to PE patients.

Saddle pulmonary embolism and clot in transit in COVID-19 infection: a case report of catastrophic venous thromboembolism.

BACKGROUND: Coronavirus disease 2019 (COVID-19) is associated with a coagulopathy favouring thrombosis over bleeding that imparts a poor prognosis. Clot in transit (CIT) is considered a rare entity and the most severe form of venous thromboembolism (VTE), carrying a higher mortality than isolated pulmonary embolism (PE). The incidence of this phenomenon in patients with COVID-19 infection is unknown and likely under-recognized. CASE SUMMARY: During the peak of the COVID-19 pandemic in New York City, a 70-year-old Hispanic female presented with syncope due to a saddle PE further complicated by a highly mobile CIT. Polymerase chain reaction was positive for COVID-19 infection, however, there was no evidence of lung parenchymal involvement or hyper-inflammation. Based on consensus from a multidisciplinary team, aspiration thrombectomy was attempted to treat this extreme case of VTE, however, the patient died during the procedure. DISCUSSION: This case raises awareness to the most catastrophic form of VTE, presenting in an early phase of COVID-19 infection without the typical hyper-inflammation and severe lung injury associated with development of COVID-related coagulopathy. It also serves to inform on the critical role echocardiography has in the comprehensive evaluation and re-evaluation of hospitalized patients with COVID-19, and the importance of a multidisciplinary organized approach in clinical decision-making for this complex and poorly understood disease and its sequelae.

Use, Safety and Effectiveness of Subintimal Angioplasty and Re-Entry Devices for the Treatment of Femoropopliteal Chronic Total Occlusions: A Systematic Review of 87 Studies and 4,665 Patients.

BACKGROUND: Subintimal angioplasty (SIA) is often utilized to cross femoropopliteal (FP) artery chronic total occlusions (CTOs). Re-entry devices (RED) can further assist with true lumen re-entry. OBJECTIVE: To systematically review the literature for studies reporting on the use of SIA, with or without RED. METHODS: A systematic review according to the PRISMA guidelines was performed. Quantitative synthesis was applied when possible. RESULTS: 87 studies and 4665 patients (5161 lesions) were included (63.9% male). 46.7% of patients had critical limb ischemia at the time of the intervention. Two RED types were used (Pioneer and Outback). Sixty-eight studies included lesions treated with SIA without RED, 17 studies included lesions treated with RED only, and two studies included a comparison between the two treatment methods. In total, 3898 (83.6%) patients were treated with SIA without RED and 754 (12.2%) with RED. Procedural success rate ranged from 64.5%-100% (92.5% for SIA without RED, 88.3% for RED cases). The complication rate ranged from 1.6% - 28% among different studies (cumulative rates: SIA: 9.1%, RED 9.3%). Perforations occurred in 1.6% of the total population (n = 46). Primary patency at one year ranged from 22% to 94.1%. Newer studies had a higher patency rate, ranging from 70% to 94.1%. CONCLUSION: SIA with or without RED is a valuable alternative to intraluminal crossing for endovascular treatment of FP CTOs. Procedural success was excellent for both techniques, while the cumulative complication rate was numerically lower in the RED group. Short- and long-term outcomes were acceptable for both techniques.

Direct Transcervical Access vs the Transfemoral Approach for Carotid Artery Stenting: A Systematic Review and Meta-Analysis.

PURPOSE: To examine the safety profile of transcervical access (TCA) in comparison with the transfemoral approach (TFA) in carotid artery stenting. MATERIALS AND METHODS: A systematic review and meta-analysis was performed according to current guidelines. Eleven eligible studies including 11,592 patients (10,736 in the TFA group and 856 in the TCA group) were identified through a search of the PubMed, Scopus, and Cochrane databases up to October 2018. A random effects model meta-analysis was conducted, and the I2 statistic was used to assess heterogeneity. Publication bias was assessed using funnel plots and quantified using the Egger method. RESULTS: The TFA group had a statistically significantly higher risk of periprocedural (30-day) stroke compared with the TCA group (OR 1.98, 95% CI 1.08 to 3.63, p=0.027; I2=0%). Also, patients in the TFA group had a significantly higher risk of developing new ischemic lesions (OR 2.97, 95% CI 1.48 to 5.96, p=0.002; I2=0%) on diffusion-weighted magnetic resonance imaging (DW-MRI). No differences in terms of transient ischemic attack (OR 1.50, 95% CI 0.73 to 3.10, p=0.268; I2=5.9%), myocardial infarction (OR 0.64, 95% CI 0.30 to 1.35; p=0.242; I2=0%), local hematoma (OR 0.53, 95% CI 0.12 to 2.25, p=0.389; I2=0%), or mortality (OR 1.35, 95% CI 0.62 to 2.92, p=0.449; I2=0%) were identified between the groups. CONCLUSION: TCA is associated with a significantly lower risk for periprocedural stroke and DW-MRI ischemic lesions compared with TFA. Other periprocedural outcomes were similar between the groups.

Percutaneous versus surgical management of lower extremity peripheral artery disease.

Lower extremity peripheral artery disease (PAD) is highly prevalent and can manifest as intermittent claudication or, in the most advanced form, critical limb ischemia. Revascularization, which can be accomplished by an endovascular or surgical approach, is performed to improve quality of life or, in severe cases, for limb salvage. Over the past decade, percutaneous catheter-based techniques have improved such that acute procedural success is high even in complex anatomy. Patency rates have also increased with the use of atherectomy devices and drug-eluting stents. Often, patients with PAD have comorbidities that increase the risk of cardiovascular complications with surgical procedures. These factors have led to the adoption of an endovascular first strategy with surgical management reserved for selected patients. This review focuses on the most current clinical trials of endovascular therapy for PAD. In addition, older but relevant studies comparing endovascular and surgical approaches and contemporary surgical trials are presented for reference.

Prophylactic use of intra-aortic balloon pump for high-risk percutaneous coronary intervention: will the Impella LP 2.5 device show superiority in a clinical randomized study?

OBJECTIVES: This study aimed to report the in-hospital and 30-day event rates in patients undergoing non-emergent, high-risk percutaneous coronary intervention (PCI) and to evaluate whether the Impella Recover LP 2.5 device (Abiomed, Danvers, MA) demonstrates superiority over intra-aortic balloon pump (IABP) in the Protect II (A Prospective Feasibility Trial Investigating the Use of the Impella Recover LP 2.5 System in Patients Undergoing High Risk Percutaneous Coronary Intervention) study. BACKGROUND: Patients undergoing non-emergent, high-risk PCI are often treated with prophylactic IABP for hemodynamic support. METHODS: A cohort of 85 patients who met the inclusion/exclusion criteria of the Protect II study was included in this retrospective analysis. High-risk PCI was defined as intervention to the last patent coronary conduit or to an unprotected left main or in a patient with three-vessel disease with an ejection fraction of