Feasibility and Outcomes of a Cardiovascular Medicine Inclusive Extracorporeal Membrane Oxygenation (ECMO) Service.

Background: There has been a significant increase in the utilization of venoarterial extracorporeal membrane oxygenation (VA-ECMO) in recent years. Cardiothoracic surgery teams have historically led VA-ECMO care teams, with little data available on alternative care models. Methods: We performed a retrospective review of a cardiovascular medicine inclusive VA-ECMO service, analyzing patients treated with peripheral VA-ECMO at a large quaternary care center from 2018 to 2022. The primary outcome was death while on VA-ECMO or within 24 hours of decannulation. Univariate and multivariate analyses were used to identify predictors of the primary outcome. Results: Two hundred forty-four patients were included in the analysis (median age 61 years; 28.7% female), of whom 91.8% were cannulated by interventional cardiologists, and 84.4% were managed by a cardiology service comprised of interventional cardiologists, cardiac intensivists or advanced heart failure cardiologists. Indications for VA-ECMO included acute myocardial infarction (34.8%), decompensated heart failure (30.3%), and refractory cardiac arrest (10.2%). VA-ECMO was utilized during cardiopulmonary resuscitation in 26.6% of cases, 48% of which were peri-procedural arrest. Of the patients, 46% survived to decannulation, the majority of whom were decannulated percutaneously in the cardiac catheterization laboratory. There was no difference in survival following cannulation by a cardiac surgeon vs interventional cardiologist (50% vs 45%; P = .90). Complications included arterial injury (3.7%), compartment syndrome (4.1%), cannulation site infection (1.2%), stroke (14.8%), acute kidney injury (52.5%), access site bleeding (16%) and need for blood transfusion (83.2%). Elevated baseline lactate (odds ratio [OR], 1.13 per unit increase) and sequential organ failure assessment score (OR, 1.27 per unit increase) were independently associated with the primary outcome. Conversely, an elevated baseline survival after VA ECMO score (OR, 0.92 per unit increase) and 8-hour serum lactate clearance (OR, 0.98 per % increase) were independently associated with survival. Conclusions: The use of a cardiovascular medicine inclusive ECMO service is feasible and may be practical in select centers as indications for VA-ECMO expand.

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.

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.

Longer-Term Outcomes Following Mechanical Thrombectomy for Intermediate- and High-Risk Pulmonary Embolism: 6-Month FLASH Registry Results.

Background: Mechanical thrombectomy provides rapid hemodynamic improvements after acute pulmonary embolism (PE), but long-term benefits are uncertain. Methods: FlowTriever All-comer Registry for Patient Safety and Hemodynamics is a prospective, single-arm, multicenter registry of patients with acute PE treated with the FlowTriever System (Inari Medical). Six-month outcomes including modified Medical Research Council dyspnea scores (MMRCD), right ventricular (RV) function, 6-minute walk test distances, and PE quality-of-life scores (QoL) were assessed. Results: In total, 799 patients were enrolled and 75% completed the study with a mean follow-up of 204 ± 46 days. Demographic characteristics included 54.1% men, mean age of 61.2 years, 77.1% intermediate-high-risk PE, and 8.0% high-risk PE. All-cause mortality was 4.6% at study completion. The proportion of patients with normal echocardiographic RV function increased from 15.1% at baseline to 95.1% at 6 months (P < .0001). MMRCD score improved from 3.0 at baseline to 0.0 at 6 months (P < .0001). 6-minute walk test distances increased from 180 m at 48 hours to 398 m at 6 months (P < .001). Median PE QoL total scores were 9.38 at 30 days and 4.85 at 6 months (P < .001). Prevalence of site-reported chronic thromboembolic pulmonary hypertension was 1.0% and chronic thromboembolic disease was 1.9%. Conclusions: In this large diverse group of PE patients, 6-month all-cause mortality, chronic thromboembolic pulmonary hypertension, and chronic thromboembolic disease were low following thrombectomy with the FlowTriever system. Significant improvements in RV function, patient symptoms, exercise capacity, and QoL were observed at 6 months, suggesting that rapid extraction of thrombus may prevent long-term sequelae in patients with PE.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.