Sex-related difference in the use of percutaneous left ventricular assist device in patients undergoing complex high-risk percutaneous coronary intervention: Insight from the cVAD registry.

OBJECTIVE: To assess the in-hospital and short-term outcome differences between males and females who underwent high-risk PCI with mechanical circulatory support (MCS). BACKGROUND: Sex differences have been noted in several percutaneous coronary intervention (PCI) series with females less likely to be referred for PCI due increased risk of adverse events. However, data on sex differences in utilization and outcomes of high-risk PCI with MCS is scarce. METHODS: Using the cVAD Registry, we identified 1,053 high-risk patients who underwent PCI with MCS using Impella 2.5 or Impella CP. Patients with cardiogenic shock were excluded. A total of 792 (75.21%) males and 261 (24.79%) females were included in the analysis with median follow-up of 81.5 days. RESULTS: Females were more likely to be African American, older (72.05 ± 11.66 vs. 68.87 ± 11.17, p < .001), have a higher prevalence of diabetes (59.30 vs. 49.04%, p = .005), renal insufficiency (35.41 vs. 27.39%, p = .018), and peripheral vascular disease (31.89 vs. 25.39%, p of .05). Women had a higher mean STS score (8.21 ± 8.21 vs. 5.04 ± 5.97, p < .001) and lower cardiac output on presentation (3.64 ± 1.30 vs. 4.63 ± 1.49, p < .001). Although women had more comorbidities, there was no difference in in-hospital mortality, stroke, MI or need for recurrent revascularization compared to males. Females were more likely to have multivessel revascularization than males. Ejection fraction improved in both males and females at the time of discharge (26.59 to 31.40% and 30.75 to 36.05%, respectively, p < .0001). However, females had higher rate of bleeding requiring transfusion compared with males (9.58 vs. 5.30%, p = .019). CONCLUSION: Female patients undergoing high PCI were older and had more comorbidities but had similar outcomes compared to males.

Large bore occlusive sheath management.

The field of interventional cardiology has evolved in its ability to carry out complex procedures. Procedures such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR), and mechanical circulatory support (MCS) devices require large bore access for successful deployment. With the use of large bore-access, comes with it an increased risk for vascular complications, such as thrombosis and limb ischemia. It is paramount for the interventional cardiologist to know how to manage such complications. In this manuscript, we describe our strategies for the management of occlusive sheaths increasingly encountered with large bore accesses in the upper and lower extremities. Strategies such as peeling away of the introducer sheath and the creation of internal and external bypass circuits are described. By using the described techniques, one can provide prolonged hemodynamic support and maintain large bore sheath access, without jeopardizing perfusion to the extremity.

In-hospital outcomes of transcatheter mitral valve repair with Mitraclip in patients with pulmonary hypertension: Insights from the National Inpatient Sample.

BACKGROUND: Periprocedural outcomes of transcatheter mitral valve repair (TMVR) with Mitraclip in patients with pulmonary hypertension (PH) are not well studied. METHODS: Patients who underwent TMVR with Mitraclip between 2011 and 2015 were identified using the National Inpatient Sample (NIS). All missing variables were excluded from the analysis and therefore, complete case analysis was performed. RESULTS: A total of 1,037 patients underwent TMVR with Mitraclip between 2011 and 2015. The prevalence of PH in these patients was 32.6%. In-hospital outcomes were compared between PH group and non-PH group. Inpatient mortality after TMVR was similar between the two groups (3.2% vs. 2.1%, OR 1.57, P = 0.335). There was no statistical significance between the two groups in the rates of hemorrhage requiring transfusion (8.5% vs. 7.2%, OR 1.17, P = 0.587), cardiogenic shock (4.4% vs. 4.5%, OR 0.98, P = 0.951), acute respiratory failure (15.2% vs. 13.1%, OR 1.23, P = 0.460), postoperative sepsis (2.75% vs. 3.9%, OR 0.66, P = 0.340), postoperative deep vein thrombosis or pulmonary embolism (2.7% vs. 3.9%, OR 1.98, P = 0.348). In addition, non-routine home discharge, median hospital cost and length of stay were similar between the two groups. CONCLUSION: Pre-existing PH in patients undergoing TMVR with Mitraclip does not adversely affect in-hospital outcomes in this cohort of patients. Therefore, PH does not carry a prohibitive risk in selecting patients for Mitraclip procedure.

Catheter-directed therapy for acute pulmonary embolism in children.

BACKGROUND: Acute pulmonary embolism is a life-threatening condition and rarely occurs in children. In adults, catheter-directed therapy emerges as a potentially safer and effective therapeutic option. However, there is a paucity of data on the safety and efficacy of catheter-directed therapy for pulmonary embolism in children. We report a single-centred experience of catheter-directed therapy for acute pulmonary embolism in children. METHODS: This is a retrospective study of children who had no CHD and underwent catheter-directed therapy at Detroit Medical Center during a 12-year period from 2005 to 2017. Demographic and clinical data associated with pulmonary embolism were collected along with the outcome. RESULTS: A total of nine patients of median age 16 years with the range from 12 to 20 received catheter-directed therapy for sub-massive (n = 6) and massive pulmonary embolism (n = 3). Among nine patients, one patient received Angiojet thrombectomy and balloon angioplasty, whereas eight patients received catheter-directed thrombolysis using tissue plasminogen activator through infusion catheters (n = 3) or EkoSonic ultrasound-accelerated thrombolysis system (n = 5). In four out of five patients treated with EkoSonic, significant clinical improvement was noticed within 24 hours. Among seven patients who survived, two patients had minor gastrointestinal bleeding with median hospital stay of 8 days with the range from 5 to 24 days, and two patients with massive pulmonary embolism died possibly due to delayed institution of catheter-directed therapy. CONCLUSION: Catheter-directed therapy with/without EkoSonic is an emerging alternative therapy for sub-massive and massive pulmonary embolism in children. A timely institution of catheter-directed therapy appeared important to improve the outcome.

Pre-close technique of percutaneous closure for delayed hemostasis of large-bore femoral sheaths.

Advancement of coronary interventions and portable hemodynamic device requires placement of large bore sheaths. Access for large caliber sheaths, its placement, maintenance, and hemostasis is very challenging and one of the key ailments for successful procedures. Traditional hemostasis method is manual compression, which is unattractive due to its own limitations and subsequent complications. Single closure device for sheath size larger than 8 French (Fr) is not available. We performed retrospective analysis of large cohort of patients with 13, 14 Fr sheaths (Impella device [ABIOMED]) percutaneous closure with the use of two Perclose devices. Two perclose devices were placed in a "Preclose" fashion and hemostasis was obtained few days later once hemodynamic support was weaned off by deployment of perclose sutures.

Mechanical circulatory support for acute right ventricular failure in the setting of pulmonary embolism.

BACKGROUND: Right ventricular (RV) failure due to pulmonary embolism (PE) increases morbidity and mortality and contributes to prolonged hospital length of stay and higher costs of care. RV mechanical circulatory support (MCS) including Impella RP devices have been increasingly used in hemodynamically compromised PE patients who are refractory to intravascular volume expansion and inotropic therapy. However, effectiveness and safety of Impella RP, in hemodynamically unstable PE patients is unknown. METHODS: We included consecutive patients who presented to Detroit Medical Center between November 3, 2015 and October 2, 2017 with acute PE and had evidence of hemodynamic compromise indicating Impella RP. RESULTS: Total of five cases were identified. All patients met the shock definition due to massive or submassive PE and therefore received Impella RP on admission. Cardiac index was improved from mean of 1.69/min/m2, (0.88-2.15 L/min/m2 ), to 2.5 L/min/m2 (range 1.88-3.4), after 24 h of treatment. Similarly, mean heart rate reduced to 92 beats per minute (79-105), and mean systolic blood pressure increased to 140 mmHg (115-179). No significant changes were found in renal function, hemoglobin and platelets level during device use. One patient experienced hemoglobin drop from 13.7 to 7.3 g/dL but did not require blood transfusion. All patients survived to discharge. CONCLUSION: In patients with PE and RV shock, Impella RP device resulted in immediate hemodynamic benefit with reversal of shock and favorable survival to discharge.

The impact of atrial fibrillation on transcatheter mitral valve repair outcomes: A propensity-matched analysis.

BACKGROUND: The concomitant presence of atrial fibrillation (AF) in the setting of Transcatheter Mitral Valve Repair (TMVR) represents a clinical challenge. Despite the high AF burden in patients presenting for the TMVR procedure, there are no studies that evaluate the impact of AF on in-hospital outcomes of TMVR in a nationally representative United States sample reflecting real practice. Therefore, we sought to study the outcomes of AF patients undergoing TMVR. METHODS AND RESULTS: The study included 1026 patients from the National Inpatient Sample (NIS) registry. Patients (age ≥18 years) who had undergone TAVR as a primary procedure from 2011 to 2014 were included, using the ICD-9-CM diagnostic codes. We examined patient characteristics and in-hospital outcomes. To account for patient and hospital-level baseline differences, we performed propensity score-matched analysis. The prevalence of AF was approximately 56%. After adjusting for patient-level and hospital-level characteristics, there was no statistical difference regarding in-hospital mortality (odds ratio [OR] 0.72, 95%CI 0.29-1.80, P = 0.487), post-TMVR complications, length of stay (OR 1.15, 95%CI 0.97-1.38, P = 0.111), and cost of hospitalization (OR 1.04, 95%CI 0.94-1.14, P = 0.475) between the group with AF versus without AF. However, patients with AF were more likely to have non-routine hospital discharge (42.94% vs 35.48% P = 0.02). CONCLUSION: AF is a frequently encountered arrhythmia among patients undergoing TMVR with MitraClip. However, TMVR can be performed safely in the vast majority of patients, irrespective of their baseline rhythm.

Access and closure management of large bore femoral arterial access.

Femoral and radial artery access continue to be the standard of care for percutaneous coronary interventions. Cardiac catheterization has progressed to encompass a wide range of diagnostic and interventional procedures including coronary, peripheral, endovascular, and structural heart disease interventions. Despite advanced technology to make these procedures safe, bleeding, and vascular complications continue to be a substantial source of morbidity, especially in patients undergoing large-bore access procedures. New variations of percutaneous devices have reduced complications associated with these procedures. However, safe vascular access with effective hemostasis requires special techniques which have not been well described in the literature. Large-bore femoral artery access is feasible, safe, and associated with low complication rates when a protocol is implemented. Wayne State University, Detroit Medical Center Heart Hospital is a tertiary care, high-volume center for endovascular, structural heart and complex high risk indicated procedures with more 150 procedures involving mechanical circulatory support (MCS) devices per year. In this manuscript, we describe our approach to femoral artery large-bore sheath insertion and management. Our protocol includes proper identification of the puncture site, device selection, insertion, assessment of limb perfusion while on prolong MCS support, and hemostasis techniques after sheath removal.

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.

Variability in utilization of drug eluting stents in United States: Insights from nationwide inpatient sample.

OBJECTIVES: We studied the trends and predictors of drug eluting stent (DES) utilization from 2006 to 2011 to further expound the inter-hospital variability in their utilization. BACKGROUND: We queried the Healthcare Cost and Utilization Project's Nationwide Inpatient Sample (NIS) between 2006 and 2011 using ICD-9-CM procedure code, 36.06 (bare metal stent) or 36.07 (drug eluting stents) for Percutaneous Coronary Intervention (PCI). Annual hospital volume was calculated using unique identification numbers and divided into quartiles for analysis. METHODS AND RESULTS: We built a hierarchical two level model adjusted for multiple confounding factors, with hospital ID incorporated as random effects in the model. About 665,804 procedures (weighted n = 3,277,884) were analyzed. Safety concerns arising in 2006 reduced utilization DES from 90% of all PCIs performed in 2006 to a nadir of 69% in 2008 followed by increase (76% of all stents in 2009) and plateau (75% in 2011). Significant between-hospital variation was noted in DES utilization irrespective of patient or hospital characteristics. Independent patient level predictors of DES were (OR, 95% CI, P-value) age (0.99, 0.98-0.99, <0.001), female(1.12, 1.09-1.15, <0.001), acute myocardial infarction(0.75, 0.71-0.79, <0.001), shock (0.53, 0.49-0.58, <0.001), Charlson Co-morbidity index (0.81,0.77-0.86, <0.001), private insurance/HMO (1.27, 1.20-1.34, <0.001), and elective admission (1.16, 1.05-1.29, <0.001). Highest quartile hospital (1.64, 1.25-2.16, <0.001) volume was associated with higher DES placement. CONCLUSION: There is significant between-hospital variation in DES utilization and a higher annual hospital volume is associated with higher utilization rate of DES. © 2015 Wiley Periodicals, Inc.

Endovascular Interventional Cardiology: 2015 in Review.

Minimally invasive interventional procedures have become an appealing option for patients with endovascular disease historically referred to surgery. This article reviews the major advancements and trials published in 2015.

Utilization of catheter-directed thrombolysis in pulmonary embolism and outcome difference between systemic thrombolysis and catheter-directed thrombolysis.

OBJECTIVE: The aim of the study was to assess the utilization of catheter-directed thrombolysis (CDT) and its comparative effectiveness against systemic thrombolysis in acute pulmonary embolism (PE). BACKGROUND: Contemporary real world data regarding utilization and outcomes comparing systemic thrombolysis with CDT for PE is sparse. METHODS: We queried the Nationwide Inpatient Sample from 2010 to 2012 using the ICD-9-CM diagnosis code 415.11, 415.13, and 415.19 for acute PE. We used propensity score analysis to compare outcomes between systemic thrombolysis and CDT. Primary outcome was in-hospital mortality. Secondary outcome was combined in-hospital mortality and intracranial hemorrhage (ICH). RESULTS: Out of 110,731 patients hospitalized with PE, we identified 1,521 patients treated with thrombolysis, of which 1,169 patients received systemic thrombolysis and 352 patients received CDT. After propensity-matched comparison, primary and secondary outcomes were significantly lower in the CDT group compared to systemic thrombolysis (21.81% vs. 13.36%, OR 0.55, 95% CI 0.36-0.85, P value = 0.007) and (22.89% vs. 13.36%, OR 0.52, 95% CI 0.34-0.80, P value = 0.003), respectively. The median length of stay [7 days, interquartile range (IQR) (5-9 days) vs. 7 days, IQR (5-10 days), P = 0.17] was not significant between the two groups. The CDT group had higher cost of hospitalization [$17,218, IQR ($12,272-$23,906) vs. $23,799, IQR ($17,892-$35,338), P < 0.001]. Multivariate analysis identified increasing age, saddle PE, cardiopulmonary arrest, and Medicaid insurance as independent predictors of in-hospital mortality. CONCLUSIONS: CDT was associated with lower in-hospital mortality and combined in-hospital mortality and ICH.

Mechanical Support in High-Risk Pulmonary Embolism: Review Article.

Acute pulmonary embolism (PE) may manifest with mild nonspecific symptoms or progress to a more severe hemodynamic collapse and sudden cardiac arrest. A substantial thrombotic burden can precipitate sudden right ventricular strain and failure. Traditionally, systemic thrombolytics have been employed in such scenarios; however, patients often present with contraindications, or these interventions may prove ineffective. Outcomes for this medically complex patient population are unfavorable, necessitating a compelling argument for advanced therapeutic modalities or alternative approaches. Moreover, patients frequently experience complications beyond hemodynamic instability, such as profound hypoxia and multiorgan failure, necessitating assertive early interventions to avert catastrophic consequences. The existing data on the utilization of mechanical circulatory support (MCS) devices are not exhaustive. Various options for percutaneous MCS devices exist, each possessing distinct advantages and disadvantages. There is an imminent imperative to develop a tailored approach for this high-risk patient cohort to enhance their overall outcomes.

Racial disparities in left main stenting: insights from a real world inner city population.

BACKGROUND: Left main coronary artery (LMCA) disease is associated with significant cardiovascular mortality. The data on patient characteristics' predicting outcomes after LMCA revascularization is sparse. METHODS: A retrospective study of 227 patients with LMCA disease documented on coronary angiography from March 2000 to December 2008. Data included demographic variables, co-morbidities, cardiac function, and medications. Race was self-identified. The study outcome was a composite end-point including myocardial infarction (MI) and all-cause mortality. Cox proportional hazard analysis was performed to study the effect of various patient attributes including race and gender on the composite end-point. RESULTS: Baseline characteristics were specifically compared between individuals who had the study outcome versus those who did not. Mean age was higher in the group with study outcomes when compared to the group without any outcomes (64.3 ± 11.8 years versus 59.2 ± 13.6 years; p = 0.013). After the final multivariate regression analysis, only African American (AA) race and age were found to be independent predictors of adverse cardiac outcome at the end of the first year (race-hazard ratio (HR) 3.82, 95% confidence interval (CI) 1.38-10.62, p = 0.010; age-HR 1.08, 95% CI 1.04-1.13, p < 0.001) and at the end of the study (race-HR 2.71, 95% CI 1.44-5.10, p = 0.002; age-HR 1.03, 95% CI 1.01-1.08, p = 0.017). CONCLUSION: In our study of patients with unprotected LMCA disease, AA race, and age were significantly predictive of poor prognosis following revascularization, while gender had no predictive value in prognosticating cardiovascular mortality.

Advancements in Myocardial Infarction Management: Exploring Novel Approaches and Strategies.

In the landscape of healthcare, the management of myocardial infarction (MI) stands as a pivotal challenge and a critical juncture where advancements are reshaping the trajectory of patient care. Myocardial infarction, commonly known as a heart attack, remains a foremost contributor to global morbidity and mortality. Conventional management strategies have historically focused on rapid restoration of blood flow through revascularization techniques. However, the last decade has witnessed a profound transformation, with a burgeoning emphasis on precision medicine and innovative interventions. This contextual backdrop sets the stage for a deep dive into the realm of novel diagnostic modalities, spanning high-sensitivity biomarkers, advanced imaging techniques, and data-driven algorithms. These innovations facilitate not only early detection but also the stratification of patients, paving the way for individualized treatment plans. By targeting the underlying mechanisms of myocardial damage, these interventions hold the promise of attenuating the impact of MI and promoting cardiac regeneration. It examines the integration of telemedicine, wearable devices, and remote monitoring platforms, bridging the gap between patients and caregivers while enabling timely interventions. Additionally, the psychosocial aspects of MI recovery are explored, highlighting the integration of psychological support and lifestyle interventions to enhance long-term well-being. By exploring novel diagnostics, innovative therapies, and holistic patient-centered strategies, it underscores the collaborative efforts of medical practitioners, researchers, and technological pioneers in reshaping the trajectory of MI care. As we stand at the intersection of medical advancement and compassionate patient management, embracing these novel approaches promises a future where the impact of myocardial infarction can be mitigated, and lives can be extended and enriched.

Cannulation Strategies in Type A Aortic Dissection: Overlooked Details and Novel Approaches.

Aortic dissection type A is a life-threatening condition that frequently necessitates surgical intervention. This review focuses on central aortic cannulation, arch branch vessel (ABV) cannulation, and proximal arch cannulation as key techniques during aortic surgery. It discusses innovative solutions for addressing these challenges. The review synthesizes findings from recent studies and emphasizes the significance of meticulous planning and execution of cannulation in aortic dissection repair. This review aims to contribute to the advancement of surgical practices and the enhancement of patient outcomes in the management of type A aortic dissection (AAD) by addressing these frequently overlooked details.

Insights into endovascular revascularization in limb salvage procedures: "antegrade-retrograde" technique in chronic total occlusion.

Significant occlusions of the peripheral arterial circulation, responsible for chronic limb ischemia (CLI), are a serious cause of morbidity, mortality, and poor quality of life. The currently available treatment options for patients with severely symptomatic CLI include bypass surgery and arterial revascularization. Percutaneous transluminal angioplasty for CLI is shown to be as effective as bypass surgery at high-volume centers, and it also offers a less invasive alternative, leading to quicker patient recovery times and lower short-term costs. This case report reviews the current techniques available and discusses an "antegrade-retrograde" angioplasty approach to successfully recanalize such challenging obstructions.

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).

Deploying Mechanical Circulatory Support Via the Axillary Artery in Cardiogenic Shock and High-Risk Percutaneous Coronary Intervention.

We sought to study the feasibility of axillary artery as alternative access for mechanical circulatory support (MCS) in cardiogenic shock and high-risk percutaneous coronary intervention (HR-PCI) patients with severe occlusive peripheral artery disease (PAD). In patients with severe PAD, the iliofemoral artery may be so diseased preventing deployment of MCS, precluding the use of lifesaving therapy. In such circumstances, the axillary artery may be a viable access site. Records of all patients presenting with cardiogenic shock or HR-PCI requiring MCS through axillary artery access at our institution from January 2016 to September 2018 were examined. Demographics, clinical, procedural, and outcomes data were collected on all patients. A total of 48 patients presented with cardiogenic shock (60%) or HR-PCI (40%) requiring MCS via axillary artery due to prohibitive PAD (mean age 66 ± 11 years). Admission diagnoses were non-ST segment elevation myocardial infarction (38%), unstable angina (23%), ST segment elevation myocardial infarction (19%), and cardiac arrest (21%). Time from axillary access to activation of Impella was 11.9 ± 4 minutes. Four patients required concomitant Impella RP for right ventricular support due to biventricular cardiogenic shock. Twenty-two patients died before Impella was explanted due to multiorgan failure, stroke, and infection. None of the patients who died had vascular complications related to axillary access. Axillary artery appears to be a viable alternative access for large bore devices in patients with prohibitive PAD. As experience of the field with this approach grows, it may be the default access for deployment of large bore sheaths in the future.