Percutaneous mechanical thrombectomy in a real-world pulmonary embolism population: Interim results of the FLASH registry.

OBJECTIVES: The FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) is a prospective multi-center registry evaluating the safety and effectiveness of percutaneous mechanical thrombectomy for treatment of pulmonary embolism (PE) in a real-world patient population (NCT03761173). This interim analysis reports outcomes for the first 250 patients enrolled in FLASH. BACKGROUND: High- and intermediate-risk PEs are characterized by high mortality rates, frequent readmissions, and long-term sequelae. Mechanical thrombectomy is emerging as a front-line therapy for PE that enables immediate thrombus reduction while avoiding the bleeding risks inherent with thrombolytics. METHODS: The primary endpoint is a composite of major adverse events (MAE) including device-related death, major bleeding, and intraprocedural device- or procedure-related adverse events at 48 h. Secondary endpoints include on-table changes in hemodynamics and longer-term measures including dyspnea, heart rate, and cardiac function. RESULTS: Patients were predominantly intermediate-risk per ESC guidelines (6.8% high-risk, 93.2% intermediate-risk). There were three MAEs (1.2%), all of which were major bleeds that resolved without sequelae, with no device-related injuries, clinical deteriorations, or deaths at 48 h. All-cause mortality was 0.4% at 30 days, with a single death that was unrelated to PE. Significant on-table improvements in hemodynamics were noted, including an average reduction in mean pulmonary artery pressure of 7.1 mmHg (22.2%, p < 0.001). Patient symptoms and cardiac function improved through follow-up. CONCLUSIONS: These interim results provide preliminary evidence of excellent safety in a real-world PE population. Reported outcomes suggest that mechanical thrombectomy can result in immediate hemodynamic improvements, symptom reduction, and cardiac function recovery.

Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction.

BACKGROUND: In ST-segment-elevation myocardial infarction (STEMI), infarct size correlates directly with heart failure and mortality. Preclinical testing has shown that, in comparison with reperfusion alone, mechanically unloading the left ventricle (LV) before reperfusion reduces infarct size and that 30 minutes of unloading activates a cardioprotective program that limits reperfusion injury. The DTU-STEMI pilot trial (Door-To-Unload in STEMI Pilot Trial) represents the first exploratory study testing whether LV unloading and delayed reperfusion in patients with STEMI without cardiogenic shock is safe and feasible. METHODS: In a multicenter, prospective, randomized exploratory safety and feasibility trial, we assigned 50 patients with anterior STEMI to LV unloading by using the Impella CP followed by immediate reperfusion (U-IR) versus delayed reperfusion after 30 minutes of unloading (U-DR). The primary safety outcome was a composite of major adverse cardiovascular and cerebrovascular events at 30 days. Efficacy parameters included the assessment of infarct size by using cardiac magnetic resonance imaging. RESULTS: All patients completed the U-IR (n=25) or U-DR (n=25) protocols with respective mean door-to-balloon times of 72 versus 97 minutes. Major adverse cardiovascular and cerebrovascular event rates were not statistically different between the U-IR versus U-DR groups (8% versus 12%, respectively, P=0.99). In comparison with the U-IR group, delaying reperfusion in the U-DR group did not affect 30-day mean infarct size measured as a percentage of LV mass (15±12% versus 13±11%, U-IR versus U-DR, P=0.53). CONCLUSIONS: We report that LV unloading using the Impella CP device with a 30-minute delay before reperfusion is feasible within a relatively short time period in anterior STEMI. The DTU-STEMI pilot trial did not identify prohibitive safety signals that would preclude proceeding to a larger pivotal study of LV unloading before reperfusion. An appropriately powered pivotal trial comparing LV unloading before reperfusion to the current standard of care is required. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03000270.

Primary percutaneous coronary intervention at centers with and without on-site surgical support: Insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

BACKGROUND: Primary percutaneous coronary intervention (PPCI) is being increasingly performed nationally at sites without on-site cardiac surgery; however, recent guidelines only provide a Class IIa recommendation for this practice. The state of Michigan has permitted PPCI without on-site surgery under a closely monitored system that mandates auditing of all procedures and quarterly feedback on quality and outcomes. This study sought to compare outcomes of patients undergoing PPCI at centers with and without on-site surgery in the state of Michigan. METHODS: Consecutive patients who underwent PPCI at 47 hospitals in Michigan from January 2010 to December 2015 were included. From this cohort, 4,091 patients from sites with and without on-site cardiac surgery were propensity matched in a 1:1 fashion to compare baseline characteristics, procedural details, and in-hospital outcomes. RESULTS: Of the 25,886 PPCIs performed at 47 hospitals in Michigan from 2010 to 2015, 21,610 (83.5%) were performed at sites with on-site surgery and 4,276 (16.5%) at sites without on-site surgery. Using propensity score matched cohorts (4,091 patients for each site type), we found no significant differences in baseline characteristics. Overall mortality (5.4% vs 5.8%; P=.442); composite outcome of in-hospital mortality, contrast-induced nephropathy, bleeding, and stroke (13.8% vs 12.8%; P=.152); and individual outcomes within the composite group showed no significant differences. Additionally, there were no clinically meaningful differences in rates of urgent/emergent coronary artery bypass graft or length of stay. Significant differences, however, were found in procedural access site, antiplatelet therapy, contrast volume, and anticoagulant strategy. CONCLUSIONS: Primary PCI performed at centers with and without cardiac surgery have comparable outcomes and complication rates when performed with close monitoring of quality and outcomes.

Early Outcomes following Endovascular, Open Surgical, and Hybrid Revascularization for Lower Extremity Acute Limb Ischemia.

BACKGROUND: Acute limb ischemia (ALI) of the lower extremity is a potentially devastating condition that requires urgent and definitive management. This challenging scenario is often treated with endovascular, open surgical, or hybrid revascularization (HyR) in an urgent basis, but the comparative effects of such therapies remain poorly defined. The purpose of this study was to compare the outcomes of endovascular, open surgical, and HyR for ALI in the contemporary era. METHODS: A large statewide cardiovascular consortium of 45 hospitals was queried for patients between January 2012 and June 2015 who underwent an endovascular, open surgical, or HyR for ALI deemed at high risk of limb loss if not treated within 24 hr (Rutherford class IIA or IIB). A propensity score weighted analysis was performed controlling for demographics, medical history, and procedure type for patients. The primary outcomes were 30-day morbidity and mortality. RESULTS: A total of 1,480 patients underwent endovascular revascularization (ER; n = 818), open surgical revascularization (OSR; n = 195), or hybrid revascularization (HyR; n = 467) for ALI. The mean age was similar across revascularization technique with an increased predominance of male gender in open surgery cohort. Comorbidities for all groups were consistent with peripheral arterial disease. The most common endovascular procedures were angioplasty (93%) and thrombolysis (49.8%), whereas the most common surgical revascularization was femoral to popliteal bypass (32.8%), femoral to tibial bypass (28.2%), and thrombectomy (19.0%); ER as compared with OSR and HyR procedures was associated with less transfusion (OSR versus ER, odds ratio [OR] 2.7; HyR versus ER, OR 2.8; P < 0.001) and major amputation (OSR versus ER, OR 3.4; HyR versus ER, OR 4.0; P < 0.001) within 30 days of intervention. There was no difference in 30-day freedom from reintervention, myocardial infarction (MI), or mortality. CONCLUSIONS: Among patients requiring urgent revascularization for Rutherford grade IIA and IIB ischemia, ER has lower 30-day morbidity but similar mortality and rates of reintervention. Although long-term patency rates were not compared, ER may offer superior short-term outcomes compared with open surgery and hybrid revascularization.

Comparison of clinical interpretation with visual assessment and quantitative coronary angiography in patients undergoing percutaneous coronary intervention in contemporary practice: the Assessing Angiography (A2) project.

BACKGROUND: Studies conducted decades ago described substantial disagreement and errors in physicians' angiographic interpretation of coronary stenosis severity. Despite the potential implications of such findings, no large-scale efforts to measure or improve clinical interpretation were subsequently undertaken. METHODS AND RESULTS: We compared clinical interpretation of stenosis severity in coronary lesions with an independent assessment using quantitative coronary angiography (QCA) in 175 randomly selected patients undergoing elective percutaneous coronary intervention at 7 US hospitals in 2011. To assess agreement, we calculated mean difference in percent diameter stenosis between clinical interpretation and QCA and a Cohen weighted κ statistic. Of 216 treated lesions, median percent diameter stenosis was 80.0% (quartiles 1 and 3, 80.0% and 90.0%), with 213 (98.6%) assessed as ≥70%. Mean difference in percent diameter stenosis between clinical interpretation and QCA was 8.2±8.4%, reflecting an average higher percent diameter stenosis by clinical interpretation (P<0.001). A weighted κ of 0.27 (95% confidence interval, 0.18-0.36) was found between the 2 measurements. Of 213 lesions considered ≥70% by clinical interpretation, 56 (26.3%) were <70% by QCA, although none were <50%. Differences between the 2 measurements were largest for intermediate lesions by QCA (50% to <70%), with variation existing across sites. CONCLUSIONS: Physicians tended to assess coronary lesions treated with percutaneous coronary intervention as more severe than measurements by QCA. Almost all treated lesions were ≥70% by clinical interpretation, whereas approximately one quarter were <70% by QCA. These findings suggest opportunities to improve clinical interpretation of coronary angiography.

Cardiogenic shock in a young woman with SCAD: The importance of early access to VA-ECMO in the community.

Spontaneous coronary artery dissection (SCAD) is a common cause of myocardial infarction in young and middle-aged women. Patients with SCAD present rarely with hemodynamic collapse and cardiogenic shock, requiring immediate resuscitation and mechanical circulatory support. Percutaneous mechanical circulatory support may serve as a bridge to recovery, decision or heart transplantation. We present a case of a young woman with SCAD of the left main coronary artery, presenting with ST-elevation myocardial infarction, cardiac arrest and cardiogenic shock. She was stabilized emergently with Impella and early escalation with extracorporeal membrane oxygenation (ECPELLA) at a non-surgical community hospital. Despite revascularization with percutaneous coronary intervention (PCI), her left ventricular recovery was poor, and ultimately required cardiac transplantation on day 5 of her presentation.

Mechanical Circulatory Support Devices in Patients with High-Risk Pulmonary Embolism.

Pulmonary embolism (PE) is a common acute cardiovascular condition. Within this review, we discuss the incidence, pathophysiology, and treatment options for patients with high-risk and massive pulmonary embolisms. In particular, we focus on the role of mechanical circulatory support devices and their possible therapeutic benefits in patients who are unresponsive to standard therapeutic options. Moreover, attention is given to device selection criteria, weaning protocols, and complication mitigation strategies. Finally, we underscore the necessity for more comprehensive studies to corroborate the benefits and safety of MCS devices in PE management.

Liberal versus conservative transfusion strategy for patients with acute myocardial infarction and anemia: A systematic review and meta-analysis.

BACKGROUND: A hemoglobin (Hb) level goal of 7-8 g/dL is a standard care threshold, prompting blood transfusion. The debate over whether acute myocardial infarction (MI) patients benefit from a more liberal transfusion strategy prompted a meta-analysis of relevant trials. METHODS: We performed a meta-analysis of randomized controlled trials (RCTs) comparing liberal and restrictive transfusion strategies in anemic MI patients. Primary outcomes were recurrent MI and death/MI, while secondary outcomes included stroke, revascularization, heart failure, and all-cause mortality. Due to the limited trials, we utilized the Paul-Mendele method with Hartung Knapp adjustment. RESULTS: Involving 2155 patients with liberal transfusion and 2170 with conservative transfusion across four RCTs, liberal transfusion did not significantly reduce MI (relative risk [RR] 0.85; 95 % CI 0.72 - 1.02, p = 0.07) or death/MI (RR 0.88; 95 % CI 0.45 - 1.71, p = 0.57). No significant differences were observed in all-cause mortality (RR 0.82; 95 % CI 0.25 - 2.68, p = 0.63), stroke (RR 0.89; 95 % CI 0.48 - 1.64, p = 0.50), revascularization (RR 0.93; 95 % CI 0.48 - 1.80, p = 0.68), or heart failure (RR 1.14; 95 % CI 0.04 - 28.84, p = 0.88). CONCLUSION: Our meta-analysis supports current medical guidelines, reinforcing the practice of limiting transfusions in acute MI patients to those with an Hb level of 7 or 8 g/dL. Liberal transfusion strategies did not show improved clinical outcomes.

MT1-MMP-dependent remodeling of cardiac extracellular matrix structure and function following myocardial infarction.

The myocardial extracellular matrix (ECM), an interwoven meshwork of proteins, glycoproteins, proteoglycans, and glycosaminoglycans that is dominated by polymeric fibrils of type I collagen, serves as the mechanical scaffold on which myocytes are arrayed for coordinated and synergistic force transduction. Following ischemic injury, cardiac ECM remodeling is initiated via localized proteolysis, the bulk of which has been assigned to matrix metalloproteinase (MMP) family members. Nevertheless, the key effector(s) of myocardial type I collagenolysis both in vitro and in vivo have remained unidentified. In this study, using cardiac explants from mice deficient in each of the major type I collagenolytic MMPs, including MMP-13, MMP-8, MMP-2, MMP-9, or MT1-MMP, we identify the membrane-anchored MMP, MT1-MMP, as the dominant collagenase that is operative within myocardial tissues in vitro. Extending these observations to an in vivo setting, mice heterozygous for an MT1-MMP-null allele display a distinct survival advantage and retain myocardial function relative to wild-type littermates in an experimental model of myocardial infarction, effects associated with preservation of the myocardial type I collagen network as a consequence of the decreased collagenolytic potential of cardiac fibroblasts. This study identifies MT1-MMP as a key MMP responsible for effecting postinfarction cardiac ECM remodeling and cardiac dysfunction.

The Use of Coronary Sinus Reducer for Refractory Angina in the U.S.: A Case Series.

Chronic refractory angina remains a common and debilitating condition for millions of people, with up to 30% of patients experiencing persistent angina despite successful revascularization. We share our experience with the implantation of a coronary sinus reducer in two complex CAD patients with refractory angina despite multiple revascularization strategies and maximally tolerated medical therapy.

Ultrasound-assisted catheter-directed thrombolysis versus anticoagulation alone for management of submassive pulmonary embolism.

BACKGROUND: Patients with submassive pulmonary embolism (PE) are vulnerable to sudden deterioration, recurrent PE, and progression to pulmonary hypertension and chronic right ventricular (RV) dysfunction. Previous studies have suggested a clinical benefit of using ultrasound-assisted catheter-directed thrombolysis (USCDT) to invasively manage patients with submassive PE. However, there is sparse data comparing the clinical outcomes of these patients when treated with USCDT versus anticoagulation (AC) alone. We sought to compare the outcomes of USCDT versus AC alone in the management of submassive PE. METHODS: 192 consecutive patients who underwent USCDT for submassive PE between January 2013 and February 2019 were identified. ICD9/ICD10 codes were used to detect 2554 patients diagnosed with PE who did not undergo thrombolysis. Propensity matching identified 192 patients with acute PE treated with AC alone. Clinical outcomes were compared between the two groups. Baseline demographics, laboratory values, and pulmonary embolism severity index scores were similar between the two cohorts. RESULTS: There was a significant reduction in mean systolic pulmonary artery pressure (sPAP) in the USCDT group compared to the AC group (∆11 vs ∆3.9 mmHg, p < 0.001). There was significant improvement in proportion of RV dysfunction in all patients, but the difference was larger in the USCDT group (∆43.3% vs ∆17.3%, p < 0.001). Patients who underwent USCDT had lower 30-day (4.3% vs 10.5%, p = 0.03), 90-day (5.5% vs 12.4%, p = 0.03), and 1-year mortality (6.2% vs 14.2%, p = 0.03). CONCLUSIONS: In patients with acute submassive PE, USCDT was associated with improved 30-day, 90-day, and 1 year mortality as compared to AC alone. USCDT also improved RV function and reduced sPAP to a greater degree than AC alone. Further studies are needed to verify these results in both short- and long-term outcomes.

Left Ventricular Remodeling After Anterior-STEMI PCI: Imaging Observations in the Door-to-Unload (DTU) Pilot Trial.

OBJECTIVES: To determine the predictive value of cardiac magnetic resonance (CMR) and echocardiographic parameters on left ventricular (LV) remodeling in ST-segment elevation myocardial infarction (STEMI) patients without cardiogenic shock and treated with mechanical LV unloading followed by immediate or delayed percutaneous coronary intervention (PCI)-mediated reperfusion. BACKGROUND: In STEMI, infarct size (IS) directly correlates with major cardiovascular outcomes. Preclinical models demonstrate mechanical LV unloading before reperfusion reduces IS. The door-to-unload (DTU)-STEMI pilot trial evaluated the safety and feasibility of LV unloading and delayed reperfusion in patients with STEMI. METHODS: This multicenter, prospective, randomized, safety and feasibility trial evaluated patients with anterior STEMI randomized 1:1 to LV unloading with the Impella CP (Abiomed) followed by immediate reperfusion vs delayed reperfusion after 30 minutes of unloading. Patients were assessed by CMR at 3-5 days and 30 days post PCI. Echocardiographic evaluations were performed at 3-5 and 90 days post PCI. At 3-5 days post PCI, patients were compared based on IS as percentage of LV mass (group 1 ≤25%, group 2 >25%). Selection of IS threshold was performed post hoc. RESULTS: Fifty patients were enrolled from April 2017 to May 2018. At 90 days, group 1 (IS ≤25%) exhibited improved LV ejection fraction (from 53.1% to 58.9%; P=.001) and group 2 (IS >25%) demonstrated no improvement (from 37.6% to 39.1%; P=.55). LV end-diastolic volume and end-systolic volume were unchanged in group 1 and worsened in group 2. There was correlation between 3-5 day and 30-day CMR measurements of IS and 90-day echocardiography-derived LV ejection fraction. CONCLUSIONS: Immediate 3-5 day post-therapy IS by CMR correlates with 90-day echocardiographic LVEF and indices of remodeling. Patients with post-therapy IS >25% demonstrated evidence of adverse remodeling. Larger studies are needed to corroborate these findings with implications on patient management and prognosis.

MT1-matrix metalloproteinase directs arterial wall invasion and neointima formation by vascular smooth muscle cells.

During pathologic vessel remodeling, vascular smooth muscle cells (VSMCs) embedded within the collagen-rich matrix of the artery wall mobilize uncharacterized proteolytic systems to infiltrate the subendothelial space and generate neointimal lesions. Although the VSMC-derived serine proteinases, plasminogen activator and plasminogen, the cysteine proteinases, cathepsins L, S, and K, and the matrix metalloproteinases MMP-2 and MMP-9 have each been linked to pathologic matrix-remodeling states in vitro and in vivo, the role that these or other proteinases play in allowing VSMCs to negotiate the three-dimensional (3-D) cross-linked extracellular matrix of the arterial wall remains undefined. Herein, we demonstrate that VSMCs proteolytically remodel and invade collagenous barriers independently of plasmin, cathepsins L, S, or K, MMP-2, or MMP-9. Instead, we identify the membrane-anchored matrix metalloproteinase, MT1-MMP, as the key pericellular collagenolysin that controls the ability of VSMCs to degrade and infiltrate 3-D barriers of interstitial collagen, including the arterial wall. Furthermore, genetic deletion of the proteinase affords mice with a protected status against neointimal hyperplasia and lumen narrowing in vivo. These studies suggest that therapeutic interventions designed to target MT1-MMP could prove beneficial in a range of human vascular disease states associated with the destructive remodeling of the vessel wall extracellular matrix.

Routine stent implantation vs. percutaneous transluminal angioplasty in femoropopliteal artery disease: a meta-analysis of randomized controlled trials.

AIMS: We performed a meta-analysis of randomized controlled trials comparing routine stenting (ST) with percutaneous transluminal angioplasty (PTA) for symptomatic superficial femoral-popliteal artery (SFPA) disease. METHODS AND RESULTS: Ten trials were pooled randomizing patients to ST (n = 724 limbs) or PTA with provisional stenting (n = 718 limbs) with a follow-up period of 9-24 months. The mean lesion length was similar in the two groups (45.8 mm in the ST group and 43.3 mm in the PTA group). We calculated the summary risk ratios (RRs) for immediate technical failure, restenosis, and target vessel revascularization (TVR) using random-effects models. The immediate technical failure was higher in the PTA group than in the ST group [17.1 vs. 5.9%, respectively, RR = 0.28, 95% confidence interval (CI) = 0.15-0.54, P < 0.001], with 10.3% of the PTA patients undergoing stenting because of suboptimal result. There was a trend for lower restenosis in the ST group (37.6% in ST vs. 45.3% in PTA, RR = 0.85, 95% CI = 0.69-1.06, P = 0.146), but no difference in the need for TVR (20% in ST vs. 20.2% in PTA, RR = 0.98, 95% CI = 0.78-1.23, P = 0.89). In an analysis restricted to nitinol stents, there was a trend towards reduction in TVR (RR = 0.79, 95% CI = 0.59-1.06, P = 0.12). CONCLUSION: Despite the higher immediate success, routine stenting was not associated with a significant reduction in the rate of restenosis or TVR. Our data do not support use of routine stenting as the primary endovascular treatment for short SFPA lesions.

Trends and outcomes of non-primary PCI at sites without cardiac surgery on-site: The early Michigan experience.

INTRODUCTION: Non-primary percutaneous coronary intervention (non-PPCI) recently received certificate of need approval in the state of Michigan at sites without cardiac surgery on-site (cSoS). This requires quality oversight through participation in the BMC2 registry. While previous studies have indicated the safety of this practice, real-world comprehensive outcomes, case volume changes, economic impacts, and readmission rates at diverse healthcare centers with and without cSoS remain poorly understood. METHODS: Consecutive patients undergoing non-PPCI at 47 hospitals (33 cSoS and 14 non-cSoS) in Michigan from April 2016 to March 2018 were included. Using propensity-matching, patients were analyzed to assess outcomes and trends in non-PPCI performance at sites with and without cSOS. RESULTS: Of 61,864 PCI's performed, 50,817 were non-PPCI, with 46,096 (90.7%) performed at sites with cSoS and 4,721 (9.3%) at sites without cSoS. From this cohort, 4,643 propensity-matched patients were analyzed. Rates of major adverse cardiac events (2.6% vs. 2.8%; p = 0.443), in-hospital mortality (0.6% vs. 0.5%; p = 0.465), and several secondary clinical and quality outcomes showed no clinically significant differences. Among a small subset with available post-discharge data, there were no differences in 90-day readmission rates, standardized episode costs, or post-discharge mortality. Overall PCI volume remained stable, with a near three-fold rise in non-PPCI at sites without cSoS. CONCLUSIONS: Non-PPCI at centers without cardiac SoS was associated with similar comprehensive outcomes, quality of care, 90-day episode costs, and post-discharge mortality compared with surgical sites. Mandatory quality oversight serves to maintain appropriate equivalent outcomes and may be considered for other programs, including the performance of non-PPCI at ambulatory surgical centers in the near future.

Safety and Effectiveness of MANTA Vascular Closure Device After Large-Bore Mechanical Circulatory Support: Real-World Experience.

BACKGROUND: Real world safety and effectiveness of MANTA vascular closure device (VCD) for large bore arteriotomy closure after decannulation of mechanical circulatory support (MCS) devices is not known. METHODS: All consecutive patients who underwent large bore arteriotomy closure with MANTA VCD following decannulation of MCS between February to October 2019 at a large tertiary care academic medical center were included. Safety and effectiveness of MANTA VCD was assessed on immediate post-closure angiogram for 23 access sites, and immediate post-closure duplex arterial ultrasound or manual vascular examination for 1 access site each. Technical success was defined as achievement of arteriotomy closure in absence of major bleeding or access site endovascular or surgical intervention. RESULTS: A total of 25 MANTA VCD were placed in 22 unique patients by 7 different operators. A 14 Fr or 18 Fr MANTA VCD was used in 15 (60%) and 10 (40%) of deployments, respectively via transfemoral (n = 23, 92%) or transaxillary (n = 2, 8%) access. Technical success was achieved in 24 of 25 (96%) cases. Minor access site bleeding occurred in 3 patients (12%) and failure of MANTA VCD with major access site bleeding occurred in 1 patient (4%) requiring endovascular balloon tamponade. No cases of retroperitoneal bleeding, collagen plug embolization, covered stent placement, or surgical vascular repair were observed. CONCLUSION: In this single center experience, the use of MANTA VCD for large bore arteriotomy closure following percutaneous decannulation of MCS devices appears to be safe and effective. Larger multicenter studies of efficacy, safety, and cost-effectiveness are needed.

Impella Versus Extracorporeal Membrane Oxygenation for Acute Myocardial Infarction Cardiogenic Shock.

BACKGROUND: Percutaneous ventricular assist devices and extracorporeal membrane oxygenation (ECMO) are increasingly used for mechanical circulatory support (MCS) in patients with acute myocardial infarction with cardiogenic shock (AMI-CS) in hospitals throughout the United States. METHODS: Using the National Inpatient Sample from October 2015 to December 2017, we identified hospital admissions that underwent percutaneous coronary intervention (PCI) and non-elective Impella or ECMO placement for AMI-CS using ICD-10 codes. Propensity-score matching was performed to compare both groups for primary and secondary outcomes. RESULTS: We identified 6290 admissions for AMI-CS who underwent PCI and were treated with Impella (n = 5730, 91%) or ECMO (n = 560, 9%) from October 2015 to December 2017. After propensity-match analysis, the ECMO cohort had significantly higher in-hospital mortality (43.3% vs 26.7%, OR: 2.10, p = 0.021). The incidence of acute respiratory failure and vascular complications were significantly lower in the Impella cohort. We observed a shorter duration of hospital stay and lower hospital costs in the Impella cohort compared to those who received ECMO. CONCLUSIONS: In AMI-CS, the use of Impella was associated with better clinical outcomes, fewer complications, shorter length of hospital stay and lower hospital cost compared to those undergoing ECMO placement.

Optimal TR-band weaning strategy while minimizing vascular access site complications.

INTRODUCTION: The purpose of the study is to develop an optimal TR-Band weaning strategy while minimizing vascular access site complications of hematoma or radial artery occlusion (RAO). METHODS: The trial was a randomized, prospective, single center study of 129 patients who underwent cardiac catheterization via the radial artery. Group A was an accelerated protocol in which weaning was initiated 20 min after sheath removal. Group B was an adjusted protocol, in which weaning was dependent on the amount of anti-platelet or anti-coagulation used. All patients underwent radial artery ultrasound to demonstrate arterial patency. RESULTS: Baseline characteristics were similar in both groups, and PCI was performed in 36.7% of patients in Group A and 37.7% of patients in Group B. RAO occurred in 7.7% of patients overall, with no statistical difference between groups (Group A 5% versus Group B 10.1%, p-value = 0.337). Hematoma formation >5 cm in diameter occurred in 4.6% of patients in the overall cohort, without statistical difference between groups (Group A 5% versus Group B 4.3%, p-value = 1). The TR-Band duration was significantly shorter in Group A compared to Group B (112.9 ±â€¯50.7 versus 130.7 ±â€¯51.1 in minutes, respectively, p-value = 0.013). CONCLUSION: We have demonstrated an accelerated weaning protocol is simple to utilize for nursing staff without increased vascular site complications of RAO or hematoma formation.

Randomized Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions: The CrossBoss First Trial.

OBJECTIVES: The authors performed a multicenter, randomized-controlled, clinical trial comparing upfront use of the CrossBoss catheter versus antegrade wire escalation for antegrade crossing of coronary chronic total occlusions. BACKGROUND: There is equipoise about the optimal initial strategy for crossing coronary chronic total occlusions. METHODS: The primary endpoints were the time required to cross the chronic total occlusion or abort the procedure and the frequency of procedural major adverse cardiovascular events. The secondary endpoints were technical and procedural success, total procedure time, fluoroscopy time required to cross and total fluoroscopy time, total air kerma radiation dose, total contrast volume, and equipment use. RESULTS: Between 2015 and 2017, 246 patients were randomized to the CrossBoss catheter (n = 122) or wire escalation (n = 124) at 11 U.S. centers. The baseline clinical and angiographic characteristics of the study groups were similar. Technical and procedural success were 87.8% and 84.1%, respectively, and were similar in the 2 groups. Crossing time was similar: 56 min (interquartile range: 33 to 93 min) in the CrossBoss group and 66 min (interquartile range: 36 to 105 min) in the wire escalation group (p = 0.323), as was as the incidence of procedural major adverse cardiovascular events (3.28% vs. 4.03%; p = 1.000). There were no significant differences in the secondary study endpoints. CONCLUSIONS: As compared with wire escalation, upfront use of the CrossBoss catheter for antegrade crossing of coronary chronic total occlusions was associated with similar crossing time, similar success and complication rates, and similar equipment use and cost.