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Contemporary practices for hemodynamically supported high-risk percutaneous coronary intervention have evolved over the last decade. This study sought to compare outcomes of the prospective, multicenter, PROTECT III study to historic patients treated with Impella in the PROTECT II randomized controlled trial.Of 1,134 patients enrolled in PROTECT III from March 2017 to March 2020, 504 were "PROTECT II-like" (met eligibility for PROTECT II randomized controlled trial) and are referred to as PROTECT III for comparative analysis. Major adverse cardiac and cerebrovascular events (MACCE), comprising all-cause mortality, stroke/transient ischemic attack, myocardial infarction, and repeat revascularization, were compared at hospital discharge and 90 days.Compared with PROTECT II (N = 216), PROTECT III patients were less often Caucasian (77.1% vs 83.8%, P = .045), with less prior CABG (13.7% vs 39.4%; P.001) and prior myocardial infarction (40.7% vs 69.3%; P.001). More PROTECT III patients underwent rotational atherectomy (37.1% vs 14.8%, P.001) and duration of support was longer (median 1.6 vs 1.3 hours; p0.001), with greater improvement achieved in myocardial ischemia jeopardy scores (7.0±2.4 vs 4.4±2.9; P.001) and SYNTAX scores (21.4±10.8 vs 15.7±9.5; P.001). In-hospital bleeding requiring transfusion was significantly lower in PROTECT III (1.8% vs 9.3%; P.001), as was procedural hypotension (2.2% vs 10.1%; P.001) and cardiopulmonary resuscitation or ventricular arrhythmia (1.6% vs 6.9%; P.001). At 90 days, MACCE was 15.1% and 21.9% in PROTECT III and PROTECT II, respectively (p=0.037). Following propensity score matching, Kaplan-Meier analysis showed improved 90-day MACCE rates in PROTECT III (10.4% vs 16.9%, P = .048).The PROTECT III study demonstrates improved completeness of revascularization, less bleeding, and improved 90-day clinical outcomes compared to PROTECT II for Impella-supported high-risk percutaneous coronary intervention among patients with severely depressed LVEF.

Background: Poor myocardial reperfusion due to distal embolization and microvascular obstruction after percutaneous coronary intervention is associated with increased risk of morbidity and mortality. Prior trials have not shown a clear benefit of routine manual aspiration thrombectomy. Sustained mechanical aspiration may mitigate this risk and improve outcomes. The objective of this study is to evaluate sustained mechanical aspiration thrombectomy before percutaneous coronary intervention in high thrombus burden acute coronary syndrome patients. Methods: This prospective study evaluated the Indigo CAT RX Aspiration System (Penumbra Inc, Alameda CA) for sustained mechanical aspiration thrombectomy before percutaneous coronary intervention at 25 hospitals across the USA. Adults presenting within 12 hours of symptom onset with high thrombus burden and target lesion(s) located in a native coronary artery were eligible. The primary end point was a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure within 30 days. Secondary end points included Thrombolysis in Myocardial Infarction thrombus grade, Thrombolysis in Myocardial Infarction flow, myocardial blush grade, stroke, and device-related serious adverse events. Results: From August 2019 through December 2020, a total of 400 patients were enrolled (mean age 60.4 years, 76.25% male). The primary composite end point rate was 3.60% (14/389 [95% CI, 2.0–6.0%]). Rate of stroke within 30 days was 0.77%. Final rates of Thrombolysis in Myocardial Infarction thrombus grade 0, Thrombolysis in Myocardial Infarction flow 3, and myocardial blush grade 3 were 99.50%, 97.50%, and 99.75%, respectively. No device-related serious adverse events occurred. Conclusions: Sustained mechanical aspiration before percutaneous coronary intervention in high thrombus burden acute coronary syndrome patients was safe and was associated with high rates of thrombus removal, flow restoration, and normal myocardial perfusion on final angiography.

Acute pulmonary embolism (PE) leads to an abrupt increase in pulmonary vascular resistance and right ventricular afterload, and when significant enough, can result in hemodynamic instability. High-risk PE is a dire cardiovascular emergency and portends a poor prognosis. Traditional therapeutic options to rapidly reduce thrombus burden like systemic thrombolysis and surgical pulmonary endarterectomy have limitations, both with regards to appropriate candidates and efficacy, and have limited data demonstrating their benefit in high-risk PE. There are growing percutaneous treatment options for acute PE that include both localized thrombolysis and mechanical embolectomy. Data for such therapies with high-risk PE are currently limited. However, given the limitations, there is an opportunity to improve outcomes, with percutaneous treatments options offering new mechanisms for clot reduction with a possible improved safety profile compared with systemic thrombolysis. Additionally, mechanical circulatory support options allow for complementary treatment for patients with persistent instability, allowing for a bridge to more definitive treatment options. As more data develop, a shift toward a percutaneous approach with mechanical circulatory support may become a preferred option for the management of high-risk PE at tertiary care centers.

Background: Despite advances in surgery and pharmacotherapy, there remains significant residual ischemic risk after coronary artery bypass grafting surgery. Methods: In REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl–Intervention Trial), a multicenter, placebo-controlled, double-blind trial, statin-treated patients with controlled low-density lipoprotein cholesterol and mild to moderate hypertriglyceridemia were randomized to 4 g daily of icosapent ethyl or placebo. They experienced a 25% reduction in risk of a primary efficacy end point (composite of cardiovascular death, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina) and a 26% reduction in risk of a key secondary efficacy end point (composite of cardiovascular death, myocardial infarction, or stroke) when compared with placebo. The current analysis reports on the subgroup of patients from the trial with a history of coronary artery bypass grafting. Results: Of the 8179 patients randomized in REDUCE-IT, a total of 1837 (22.5%) had a history of coronary artery bypass grafting, with 897 patients randomized to icosapent ethyl and 940 to placebo. Baseline characteristics were similar between treatment groups. Randomization to icosapent ethyl was associated with a significant reduction in the primary end point (hazard ratio [HR], 0.76 [95% CI, 0.63–0.92]; P =0.004), in the key secondary end point (HR, 0.69 [95% CI, 0.56–0.87]; P =0.001), and in total (first plus subsequent or recurrent) ischemic events (rate ratio, 0.64 [95% CI, 0.50–0.81]; P =0.0002) compared with placebo. This yielded an absolute risk reduction of 6.2% (95% CI, 2.3%–10.2%) in first events, with a number needed to treat of 16 (95% CI, 10–44) during a median follow-up time of 4.8 years. Safety findings were similar to the overall study: beyond an increased rate of atrial fibrillation/flutter requiring hospitalization for at least 24 hours (5.0% vs 3.1%; P =0.03) and a nonsignificant increase in bleeding, occurrences of adverse events were comparable between groups. Conclusions: In REDUCE-IT patients with a history of coronary artery bypass grafting, treatment with icosapent ethyl was associated with significant reductions in first and recurrent ischemic events. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01492361.

Percutaneous ventricular assist devices (pVAD) are frequently utilized in high-risk percutaneous coronary intervention (HR-PCI) to provide hemodynamic support in patients with complex cardiovascular disease and/or multiple comorbidities who are poor candidates for surgical revascularization. Using the National Inpatient Sample we identified pVAD-assisted PCI (excluding intra-aortic balloon pump) in patients without cardiogenic shock from January 2008 to December 2018. We evaluated the trends in patient and procedural characteristics, and complication rates across the 11-year study period. A total of 26,661 pVAD-PCI was performed. From 2008 to 2018 there has was a 27-fold increase in the number of pVAD-PCIs performed annually. There has also been an increase in the proportion of procedures performed in small to medium sized hospitals. The use of atherectomy, image-guided PCI, FFR/iFR, drug-eluting stents, and multi-vessel intervention has significantly increased. Patients undergoing pVAD-PCI had a higher burden of comorbidities, without a significant difference in mortality over time. There were decreased rates of acute stroke and blood transfusions over time, while vascular complications and acute kidney injury (AKI) requiring dialysis remained mostly unchanged. In conclusion, the use of pVAD for HR-PCI has increased significantly, along with adjunctive PCI techniques such as atherectomy, intravascular imaging, and physiologic lesion assessment. With increasing use of this device, there appeared to be lower rates of peri-procedural stroke, and blood transfusions. Despite a higher burden of comorbidities, adjusted mortality remained stable over time.

Background: Patients with elevated triglycerides despite statin therapy have increased risk for ischemic events, including coronary revascularizations. Methods: REDUCE-IT (The Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial), a multicenter, double-blind, placebo-controlled trial, randomly assigned statin-treated patients with elevated triglycerides (135–499 mg/dL), controlled low-density lipoprotein (41–100 mg/dL), and either established cardiovascular disease or diabetes plus other risk factors to receive icosapent ethyl 4 g/d or placebo. The primary and key secondary composite end points were significantly reduced. Prespecified analyses examined all coronary revascularizations, recurrent revascularizations, and revascularization subtypes. Results: A total of 8179 randomly assigned patients were followed for 4.9 years (median). First revascularizations were reduced to 9.2% (22.5/1000 patient-years) with icosapent ethyl versus 13.3% (33.7/1000 patient-years) with placebo (hazard ratio, 0.66 [95% CI, 0.58–0.76]; P P P P =0.0005). Conclusions: Icosapent ethyl reduced the need for first and subsequent coronary revascularizations in statin-treated patients with elevated triglycerides and increased cardiovascular risk. To our knowledge, icosapent ethyl is the first non–low-density lipoprotein–lowering treatment that has been shown to reduce coronary artery bypass grafting in a blinded, randomized trial. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01492361.

Background Transcatheter mitral valve repair (TMVR) utilization has increased significantly in the United States over the last years. Yet, a risk-prediction tool for adverse events has not been developed. We aimed to generate a machine-learning-based algorithm to predict in-hospital mortality after TMVR. Methods Patients who underwent TMVR from 2012 through 2015 were identified using the National Inpatient Sample database. The study population was randomly divided into a training set (n = 636) and a testing set (n = 213). Prediction models for in-hospital mortality were obtained using five supervised machine-learning classifiers. Results A total of 849 TMVRs were analyzed in our study. The overall in-hospital mortality was 3.1%. A naive Bayes (NB) model had the best discrimination for fifteen variables, with an area under the receiver-operating curve (AUC) of 0.83 (95% CI, 0.80–0.87), compared to 0.77 for logistic regression (95% CI, 0.58–0.95), 0.73 for an artificial neural network (95% CI, 0.55–0.91), and 0.67 for both a random forest and a support-vector machine (95% CI, 0.47–0.87). History of coronary artery disease, of chronic kidney disease, and smoking were the three most significant predictors of in-hospital mortality. Conclusions We developed a robust machine-learning-derived model to predict in-hospital mortality in patients undergoing TMVR. This model is promising for decision-making and deserves further clinical validation.

Successful closure of large bore vascular access (≥12 Fr) is facilitated by the MANTA vascular closure device; however, it requires a critical first step of measuring "skin to arterial wall" depth of the access site using the depth locator before dilating the vessel above 8 Fr. It may be challenging at times to acquire the deployment depth at the onset of the procedure due to case urgency, delayed closure, or when large bore access is obtained at a different institution. We discuss a novel technique of measuring the deployment depth and successful delayed closure of large bore arterial access using the MANTA closure device.

Background There are increased options to deliver thrombolytic treatment for acute, high-risk pulmonary embolism (PE). The goals of this study were to examine practice patterns of systemic thrombolysis and catheter-directed thrombolysis (CDT) and to compare outcomes following CDT with ultrasound facilitation (CDT-ultrasound) and CDT alone. Methods The study analyzed adults aged > 18 years with hospitalizations associated with acute PE and thrombolysis in the 2016 Nationwide Readmissions Database. The study identified characteristics associated with the use of systemic thrombolysis and CDT. Comparisons of CDT-ultrasound vs CDT alone were then made by evaluating in-hospital events and readmissions. The primary outcomes were in-hospital mortality and 30-day readmission rates. Results Among 5,436 hospitalizations, systemic thrombolysis was used more often (n = 3,376; 62.1%) than CDT (n = 2,060; 37.9%). Compared with CDT, systemic thrombolysis was used more frequently in patients with higher rates of vasopressor use (4.3% vs 1.0%), shock (15.8% vs. 6.9%), cardiac arrest (12.7% vs 3.4%), and mechanical ventilation (19.0% vs 5.9%). Among patients who underwent CDT, 417 (20.2%) received CDT-ultrasound, and 1,643 (79.8%) received CDT alone. Rates of bleeding events, vasopressor use, and mechanical ventilation were similar between therapeutic strategies. Following adjustment, in-hospital mortality (OR, 1.19; 95% CI, 0.63-2.26; P = .59) and 30-day readmission rates (OR, 0.75; 95% CI, 0.47-1.22; P = .25) were not significantly different between CDT-ultrasound and CDT alone. Conclusions Systemic thrombolysis is used more often than CDT in patients with acute PE, in particular among those with a greater prevalence of high-risk features. Among patients treated with CDT, there were no differences in events between CDT-ultrasound and CDT alone.

To highlight updates on the use of extracorporeal membrane oxygenation (ECMO) and surgical embolectomy in the treatment of massive pulmonary embolism.Outcomes for surgical embolectomy for massive pulmonary embolism have improved in the recent past. More contemporary therapeutic options include catheter embolectomy, which although offer less invasive means of treating this condition, need further study. The use of ECMO as either a bridge or mainstay of treatment in patients with contraindications to fibrinolysis and surgical embolectomy, or have failed initial fibrinolysis, has increased, with data suggesting improved outcomes with earlier implementation in selected patients.Although surgical embolectomy continues to be the initial treatment of choice in massive pulmonary embolism with contraindications or failed fibrinolysis, the use of ECMO in these high-risk patients provides an important tool in managing this often fatal condition.

There are increasing treatment options for the management of acute pulmonary embolism (PE), though many are only available at tertiary care centers. Patients with acute pulmonary embolism with high-risk features are often transferred for consideration of such therapies. There are limited data describing outcomes in patients transferred with acute pulmonary embolism.We evaluated patients with acute pulmonary embolism at our tertiary care center from August 2012 through August 2018 and compared clinical characteristics, pulmonary embolism features, management, and outcomes in those transferred for acute pulmonary embolism to those that were not transferred.Of 2050 patients with pulmonary embolism included in the study, 432 (21.1%) were transferred from an outside hospital with a known diagnosis of pulmonary embolism. Patients transferred had a lower rate of malignancy (22.2% vs 33.3%; P.001) and median Charlson comorbidity index (3 vs 4; P.001). A higher percentage of patients transferred were classified as intermediate- or high-risk pulmonary embolism (62.5% vs 43.0%; P.001) and more frequently received advanced therapy beyond anticoagulation alone (12.5% vs 3.2%, P.001). Overall survival to discharge was similar between groups, though definite pulmonary embolism-related mortality was higher in the transferred group (38.5% vs 9.4%, P = .004).More than 1 in 5 patients treated for acute pulmonary embolism at a tertiary care center were transferred from an outside facility. Transferred patients had higher risk pulmonary embolism features, more often received advanced therapy, and had higher definite pulmonary embolism-related mortality. There are opportunities to further optimize outcomes of patients transferred for management of acute pulmonary embolism.

REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial) randomized statin-treated patients with elevated triglycerides to icosapent ethyl (IPE) or placebo. There was a significant reduction in adjudicated events, including the primary endpoint (cardiovascular [CV] death, myocardial infarction [MI], stroke, coronary revascularization, unstable angina requiring hospitalization) and key secondary endpoint (CV death, MI, stroke) with IPE.The purpose of this study was to determine the effects of IPE on investigator-reported events.Potential endpoints were collected by blinded site investigators and subsequently adjudicated by a blinded Clinical Endpoint Committee (CEC) according to a prespecified charter. Investigator-reported events were compared with adjudicated events for concordance.There was a high degree of concordance between investigator-reported and adjudicated endpoints. The simple Kappa statistic between CEC-adjudicated vs site-reported events for the primary endpoint was 0.89 and for the key secondary endpoint was 0.90. Based on investigator-reported events in 8,179 randomized patients, IPE significantly reduced the rate of the primary endpoint (19.1% vs 24.6%; HR: 0.74 [95% CI: 0.67-0.81]; P 0.0001) and the key secondary endpoint (10.5% vs 13.6%; HR: 0.75 [95% CI: 0.66-0.85]; P 0.0001). Among adjudicated events, IPE similarly reduced the rate of the primary and key secondary endpoints.IPE led to consistent, significant reductions in CV events, including MI and coronary revascularization, as determined by independent, blinded CEC adjudication as well as by blinded investigator-reported assessment. These results highlight the robust evidence for the substantial CV benefits of IPE seen in REDUCE-IT and further raise the question of whether adjudication of CV outcome trial endpoints is routinely required in blinded, placebo-controlled trials. (Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT [Reduction of Cardiovascular Events With EPA - Intervention Trial]; NCT01492361).

Background: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR. Methods: The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%. Results: Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded. Conclusions: Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04500964.

Durability of transcatheter heart valve (THV) is critical as the indication of transcatheter aortic valve implantation (TAVI) expands to patients with longer life-expectancy. We aimed to compare the durability of different THV systems (balloon-expandable [BE] and self-expandable [SE]) and surgical aortic valve replacement (SAVR) prosthesis. PUBMED and EMBASE were searched through February 2021 for randomized trials investigating parameters of valve durability after TAVI and/or SAVR in severe aortic stenosis. A network meta-analysis using random-effect model was performed. Synthesis was performed with 5-year follow-up data for echocardiographic outcomes and the longest available follow-up data for clinical outcomes. Ten trials with a total of 9,388 patients (BE-THV: 2,562; SE-THV: 2,863; SAVR: 3,963) were included. Follow-up ranged from 1 to 6 years. SE-THV demonstrated significantly larger effective orifice area, lower mean aortic valve gradient (AVG), and less increase in mean AVG at 5-year compared with BE-THV and SAVR. Structural valve deterioration (SVD) was less frequent in SE-THV compared with BE-THV and SAVR (HR 0.14, 95% CI 0.07 to 0.27; HR 0.34, 95% CI 0.24 to 0.47, respectively). Total moderate-severe aortic regurgitation and reintervention was more frequent in BE-THV (HR 4.21, 95% CI 2.40 to 7.39; HR 2.22, 95% CI 1.16 to 4.26, respectively), and SE-THV (HR 7.51, 95% CI 3.89 to 14.5; HR 2.86, 95% CI 1.59 to 5.13, respectively) compared with SAVR. In conclusion, TAVI with SE-THV demonstrated favorable forward-flow hemodynamics and lowest risk of SVD compared with BE-THV and SAVR at mid-term. However, both THV systems suffer an increased risk of AR and re-intervention, and long-term data from newer generation valves is warranted.

Background The role of basal septal hypertrophy (BSH) on preprocedural transthoracic echocardiography in transcatheter aortic valve replacement (TAVR) is unknown. Methods Medical charts and preprocedural transthoracic echocardiograms of 378 patients who underwent TAVR were examined. The association between BSH and the primary composite outcome of valve pop-out, recapture, embolization, aborted procedure, conversion to open procedure, new conduction disturbance, or need for permanent pacemaker ≤30 days after TAVR was evaluated. Patients with preexisting pacemakers were excluded. Sensitivity analyses were performed varying the definition of BSH. Results Of 296 TAVR patients (78.3%) with interpretable images, 55 (18.6%) had BSH at a median of 40 days (interquartile range, 19–62 days) before TAVR. Age and sex were similar among those with and without BSH. BSH patients received postdilation more frequently (BSH+ vs BSH−: 41.8% vs 29.9%, P = .04). A total of 50 individuals (16.9%) received pacemakers within 30 days, and 128 (43.2%) developed conduction disturbances (with left bundle branch block most common), without differences between groups. BSH was unrelated to the primary outcome on multivariate analysis (adjusted odds ratio BSH+ vs BSH−, 0.94; 95% CI, 0.42−2.11; P = .88). Conclusions In this convenience sample of TAVR recipients at a large academic medical center, patients with BSH were more likely to receive postdilation. BSH was not associated with procedural or conduction outcomes after TAVR in patients without preexisting pacemakers.

Public reporting programs for percutaneous coronary intervention (PCI) outcomes have been implemented in several states as part of a movement to improve transparency among patients, physicians, and institutions. Massachusetts has publicly reported hospital-specific PCI mortality rates since 2003.

ST-elevation myocardial infarction (STEMI) patients with multivessel disease and without shock are a common clinical entity, but the best approach to nonculprit vessel lesions remains controversial. In contrast, STEMI patients with shock do not appear to benefit from primary multivessel percutaneous coronary interventions (PCIs) during the index procedure. The optimal treatment strategy in a given STEMI patient involves an individualized approach, incorporating clinical, hemodynamic, and angiographic/imaging parameters. Patients with STEMI and cardiogenic shock may benefit from therapies other than PCI, such as mechanical cardiovascular support.

We sought to identify nontraditional risk factors coded in administrative claims data and evaluate their ability to improve prediction of long-term mortality in patients undergoing percutaneous mitral valve repair.Patients undergoing transcatheter mitral valve repair using MitraClip implantation between September 28, 2010, and September 30, 2015 were identified among Medicare fee-for-service beneficiaries. We used nested Cox regression models to identify claims codes predictive of long-term mortality. Four groups of variables were introduced sequentially: cardiac and noncardiac risk factors, presentation characteristics, and nontraditional risk factors.A total of 3782 patients from 280 clinical sites received treatment with MitraClip over the study period. During the follow-up period, 1114 (29.5%) patients died with a median follow-up time period of 13.6 (9.6 to 17.3) months. The discrimination of a model to predict long-term mortality including only cardiac risk factors was 0.58 (0.55 to 0.60). Model discrimination improved with the addition of noncardiac risk factors (c = 0.63, 0.61 to 0.65; integrated discrimination improvement [IDI] = 0.038, P0.001), and with the subsequent addition of presentation characteristics (c = 0.67, 0.65 to 0.69; IDI = 0.033, P0.001 compared with the second model). Finally, the addition of nontraditional risk factors significantly improved model discrimination (c = 0.70, 0.68 to 0.72; IDI = 0.019, P0.001, compared with the third model).Risk-prediction models, which include nontraditional risk factors as identified in claims data, can be used to predict long-term mortality risk more accurately in patients who have undergone MitraClip procedures.

Author(s): Basir, Mir B; Pinto, Duane S; Ziaeian, Boback; Khandelwal, Akshay; Cowger, Jennifer; Suh, William; Althouse, Andrew | Abstract: BackgroundAcute myocardial infarction (AMI) complicated by cardiogenic shock (CS) is associated with significant morbidity and mortality.MethodsWe provide an overview of previously conducted studies on the use of mechanical circulatory support (MCS) devices in the treatment of AMI-CS and difficulties which may be encountered in conducting such trials in the United States.ResultsWell powered randomized control trials are difficult to conduct in a critically ill patient population due to physician preferences, perceived lack of equipoise and challenges obtaining informed consent.ConclusionsWith growth in utilization of MCS devices in patients with AMI-CS, efforts to perform well-powered, randomized control trials must be undertaken.

Background: There has been increasing utilization of short-term mechanical circulatory support devices for a variety of clinical indications. Many patients have suboptimal iliofemoral access options or reasons why early mobilization is desirable. Axillary artery access is an option for these patients, but little is known about the utility of this approach to facilitate short-term use for circulatory support with microaxial pump devices. Methods: The Axillary Access Registry to Monitor Safety (ARMS) was a prospective, observational multicenter registry to study the feasibility and acute safety of mechanical circulatory support via percutaneous upper-extremity access. Results: One hundred and two patients were collected from 10 participating centers. Successful device implantation was 98% (100 of 102). Devices were implanted for a median of 2 days (interquartile range, 0–5 days; range, 0–35 days). Procedural complications included 10 bleeding events and 1 stroke. There were 3 patients with brachial plexus–related symptoms all consisting of C8 tingling and all arising after multiple days of support. Postprocedural access site hematoma or bleeding was noted in 9 patients. Device explantation utilized closure devices alone in 61%, stent grafts in 17%, balloon tamponade facilitated closure in 15%, and planned surgical explant in 5%. Duration of support appeared to be independently associated with a 1.1% increased odds of vascular complication per day ([95% CI, 0.0%–2.3%] P =0.05). Conclusions: Percutaneous axillary access for use with microaxial support pumps appears feasible with acceptable rates of bleeding despite early experience. Larger studies are necessary to confirm the pilot data presented here.

Introduction: REDUCE-IT was an event-driven trial that randomized 8,179 statin-treated patients with controlled LDL-C and moderately elevated triglycerides to icosapent ethyl (IPE) 4g daily or placebo, with a median of 4.9 years of follow-up. There was a significant reduction in the prespecified adjudicated rates of the primary endpoint (cardiovascular [CV] death, non-fatal myocardial infarction [MI], non-fatal stroke, coronary revascularization, and unstable angina requiring hospitalization) and of the key secondary endpoint (CV death, MI, stroke), as well as in all the primary endpoint components. We sought to determine the effect of IPE on investigator-reported events. Methods: The Clinical Endpoint Committee (CEC) blindly adjudicated investigator-reported events according to a prespecified charter. Medical records and reports were also reviewed to assess for clinical events not reported by investigators. An endpoint management team compiled and electronically provided event packets to the CEC via an adjudication database. The CEC Chair provided final adjudication if the two primary adjudicators could not reach consensus. Results: IPE significantly reduced the rate of the primary endpoint (hazard ratio 0.74, p=0.0000000002) and the key secondary endpoint (hazard ratio 0.75, p=0.000007) as reported by the site investigators, with consistent benefits in each component of the primary endpoint (Table). There was a high degree of concordance between investigator-reported and adjudicated endpoints. Conclusions: Icosapent ethyl significantly reduced multiple types of ischemic events, both by independent, blinded adjudication as well as by investigator-reported assessment. These results underscore the robustness of the benefits of icosapent ethyl seen in REDUCE-IT.

A 21-year-old man presented to an outside hospital with 10 days of fever, fatigue, and malaise. On exam, temperature was 106F, blood pressure 85/50 mm Hg, and heart rate 121 bpm. He was cold and clammy, with elevated jugular venous pressure, normal heart sounds, clear lungs, and cool extremities without edema. Laboratory results were notable for elevated white blood cell count (predominantly neutrophils), serum triglycerides, ferritin, C-reactive protein, coagulation parameters, and positive Monospot test. Following blood cultures, he was initiated on broad spectrum antibiotics, fluid resuscitated, and started on norepinephrine, epinephrine, and phenylepehrine. Shortly after transfer to our institution, although asymptomatic, an electrocardiogram demonstrated diffuse 5 mm ST-elevations with elevated cardiac biomarkers. A transthoracic echocardiogram demonstrated biventricular contractile dysfunction with ejection fraction 20% and apical akinesis. The patient was diagnosed with mixed cardiogenic and distributive shock. Cardiogenic shock was attributed to myocarditis with possible vasospasm or cytokine-induced myocardial suppression. Coronary angiogram was deferred given low suspicion for thrombotic acute coronary syndrome. Cardiac MRI showed subepicardial early and late gadolinium enhancement consistent with myocarditis, but negative viral serologies. Distributive shock was thought to be due to sepsis or hemophagocytic lymphohistiocytosis (HLH). The patient received empiric dexamethasone for HLH; and the diagnosis was confirmed on bone marrow biopsy. Blood cultures grew Fusobacterium necrophorum and neck imaging revealed thrombosis of the left internal jugular vein. Lemierre syndrome, thought to be bacterial invasion in the setting of tonsillitis was diagnosed. He was treated with antibiotics and dexamethasone with rapid clinical improvement and recovery of biventricular function. We suspect EBV infection lead to Lemierre syndrome and HLH with secondary myocardial suppression from the resultant cytokine storm. This case describes the first case of HLH-related myocarditis and highlights clinical decision-making surrounding the workup and management of mixed etiologies of shock with suspected myocarditis.

Background: Patients with a prior history of coronary artery bypass grafting (CABG) are at high risk for future ischemic events despite statin therapy. Methods: REDUCE-IT, a multicenter, double-blind, placebo-controlled trial, randomized statin-treated patients with elevated triglycerides (135-499 mg/dL), controlled LDL (41-100 mg/dL), and either established cardiovascular disease or diabetes plus other risk factors to receive icosapent ethyl 4g daily or placebo. In the overall trial, the primary composite endpoint (cardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina) and the key secondary composite endpoint (cardiovascular death, myocardial infarction, stroke) were significantly reduced. Here we examine the subgroup of patients with a history of CABG. Results: A total of 8,179 randomized patients were followed for 4.9 years (median), 1837 (22.5%) of whom had a prior CABG, with a median of 5.1 years (0.7 months to 33.3 years) from CABG to randomization (in the 1263 patients who had the date of CABG recorded). The rate of the primary endpoint was reduced by 24% [22.0% with icosapent ethyl versus 28.2% with placebo (hazard ratio [HR]=0.76; 95% confidence interval [CI], 0.63-0.92; p=0.004; number needed to treat [NNT]=16)]. The rate of the key secondary endpoint was reduced by 31%: [14.7% with icosapent ethyl versus 20.7% with placebo (HR=0.69; 95% CI, 0.56-0.87; p=0.001; NNT=17)]. Conclusions: In statin-treated patients with a history of prior CABG, the addition of icosapent ethyl significantly reduced ischemic events, with both large relative and absolute risk reductions.

We aimed to examine factors impacting variability in cardiac procedural deferral during the COVID-19 pandemic and assess cardiologists' perspectives regarding its implications. Unprecedented cardiac procedural deferral was implemented nationwide during the COVID-19 pandemic. A web-based survey was administered by Society for Cardiovascular Angiography and Interventions and the American College of Cardiology Interventional Council to cardiac catheterization laboratory (CCL) directors and interventional cardiologists across the United States during the COVID-19 pandemic. Among 414 total responses, 48 states and 360 unique cardiac catheterization laboratories were represented, with mean inpatient COVID-19 burden 16.4 ± 21.9%. There was a spectrum of deferral by procedure type, varying by both severity of COVID-19 burden and procedural urgency (p < .001). Percutaneous coronary intervention volumes dropped by 55% (p < .0001) and transcatheter aortic valve replacement volumes dropped by 64% (p = .004), with cardiologists reporting an increase in late presenting ST-elevation myocardial infarctions and deaths among patients waiting for transcatheter aortic valve replacement. Almost 1/3 of catheterization laboratories had at least one interventionalist testing positive for COVID-19. Salary reductions did not influence procedural deferral or speed of reinstituting normal volumes. Pandemic preparedness improved significantly over time, with the most pressing current problems focused on inadequate testing and staff health risks. During the COVID-19 pandemic, cardiac procedural deferrals were associated with procedural urgency and severity of hospital COVID-19 burden. Yet patients did not appear to be similarly influenced, with cardiologists reporting increases in late presenting ST-elevation myocardial infarctions independent of local COVID-19 burden. The safety and importance of seeking healthcare during this pandemic deserves emphasis.

Background We systematically reviewed trials comparing different reperfusion strategies for ST‐segment–elevation myocardial infarction and used multivariate network meta‐analysis to compare outcomes across these strategies. Methods and Results We identified 31 contemporary trials in which patients with ST‐segment–elevation myocardial infarction were randomized to ≥2 of the following strategies: fibrinolytic therapy (n=4212), primary percutaneous coronary intervention ( PCI ) (n=6139), or fibrinolysis followed by routine early PCI (n=5006). We categorized the last approach as “facilitated PCI ” when the median time interval between fibrinolysis to PCI was PCI was associated with the lowest risk of mortality, nonfatal reinfarction, and stroke. For mortality, primary PCI had an odds ratio of 0.73 (95% CI , 0.61–0.89) when compared with fibrinolytic therapy. Of the remaining strategies, the pharmacoinvasive approach was the next most favorable with an odds ratio for death of 0.79 (95% CI , 0.59–1.08) compared with fibrinolytic therapy. The Bayesian model indicated that when the 2 strategies examining routine early invasive therapy following fibrinolysis were directly compared, the probability of adverse outcomes was lower for the pharmacoinvasive approach relative to facilitated PCI . Conclusions A pharmacoinvasive approach is safer and more effective than facilitated PCI and fibrinolytic therapy alone. This has significant implications for ST‐segment–elevation myocardial infarction care in settings where timely access to primary PCI , the preferred treatment for ST‐segment–elevation myocardial infarction , is not available.

A Man with Respiratory Failure and Cardiac Dysfunction A 73-year-old man presented with progressive cough, fatigue, fevers, and dyspnea during the Covid-19 pandemic; he received mechanical ventilat...

As the world slowly starts to recover from the COVID-19 pandemic, healthcare systems are now thinking about resuming elective cardiovascular procedures, including procedures in the cardiac catheterization laboratories (cath lab). Rebooting cath labs will be an arduous process in part due to limited healthcare resources, new processes and fears stemming from the COVID-19 pandemic. We propose a detailed phased-in approach that considers clinical, patient-centered, and operational strategies to safely and effectively reboot cath lab programs during these unprecedented times. This model balances delivery of essential cardiovascular care while reducing exposure and preserving resources. The guiding principles detailed in this manuscript can be used by cath lab programs when restarting elective interventional procedures., Graphical abstract

Background Ciguatera toxicity is a fish-borne illness that initially manifests with gastrointestinal symptoms, followed by bizarre neurological symptoms including heat-cold sensation alteration, peculiar feeling of loose teeth, and peripheral neuropathy. However, cardiac manifestations are rare and underreported in the literature. Case summary A 73-year-old man presented with symptomatic bradycardia and hypotension after ingestion of barracuda fish in Mexico. He received atropine and dopamine with subsequent improvement in his symptoms, but continued to experience peripheral neuropathic and other odd sensations. Four of his family members ingested the same fish and had similar symptoms. He was managed conservatively and did not require temporary or permanent pacing. Within 1 week from toxin exposure, bradycardia had improved. Heart rate was 40–50 b.p.m. at rest, and he was discharged with an ambulatory monitor. Heart rate had increased to 77 b.p.m. at 1-month follow-up on repeat electrocardiogram (ECG). Discussion Although the predominant manifestations of ciguatera toxicity are neurological, cardiac complications tend to be more acute and require attention. Unlike neurological symptoms, bradycardia and hypotension are short-lived, often resolving within a week. Treatment continues to be largely supportive, and patients may require temporary treatment with positive chronotropic agents such as atropine or dopamine.

Background Intravascular ultrasound ( IVUS ) guidance during percutaneous coronary intervention ( PCI ) offers tomographic images of the coronary vessels, allowing optimization of stent implantation at the time of PCI . However, the long‐term beneficial effect of IVUS over PCI guided by coronary angiography ( CA ) alone remains under question. We sought to investigate the outcomes of IVUS ‐guided compared with CA ‐guided PCI . Methods and Results We performed a comprehensive search of PubMed, Medline, and Cochrane Central Register, looking for randomized controlled trials and observational studies that compared PCI outcomes of IVUS with CA . Data were aggregated for the primary outcome measure using the random‐effects model as pooled risk ratio ( RR ). The primary outcomes were the rate of cardiovascular death, need for target lesion revascularization, occurrence of myocardial infarction, and rate of stent thrombosis. A total of 19 studies met the inclusion criteria, comprising 27 610 patients divided into IVUS (n=11 513) and CA (n=16 097). Compared with standard CA ‐guided PCI , we found that the risks of cardiovascular death ( RR , 0.63; 95% CI , 0.54–0.73), myocardial infarction ( RR , 0.71; 95% CI , 0.58–0.86), target lesion revascularization ( RR , 0.81; 95% CI , 0.70–0.94), and stent thrombosis ( RR , 0.57; 95% CI , 0.41–0.79) were all significantly lower using IVUS guidance. Conclusions Compared with standard CA ‐guided PCI , the use of IVUS imaging guidance to optimize stent implantation is associated with a reduced risk of cardiovascular death and major adverse events, such as myocardial infarction, target lesion revascularization, and stent thrombosis.

BACKGROUND Despite improvements in percutaneous coronary intervention (PCI), intraprocedural thrombotic events (IPTE) and bleeding complications occur and are prognostically important. These have not been included in prior economic studies. METHODS PHOENIX ECONOMICS was a substudy of the CHAMPION PHOENIX trial, evaluating cangrelor during PCI. Hospital bills were reviewed from 1,171 patients enrolled at 22 of 63 US sites. Costs were estimated using standard methods including resource-based accounting, hospital billing data, and the Medicare fee schedule. Bleeding and IPTE, defined as abrupt vessel closure (transient or sustained), new/suspected thrombus, new clot on wire/catheter, no reflow, side-branch occlusion, procedural stent thrombosis or urgent need for CABG were identified. Costs were calculated according to whether a complication occurred and type of event. Multivariate analyses were used to estimate the incremental costs of IPTE and postprocedural events. RESULTS IPTE occurred in 4.3% and were associated with higher catheterization laboratory and overall index hospitalization costs by $2,734 (95%CI $1,117, $4,351; P = 0.001) and $6,354 (95% CI $4,122, $8,586; P

AIMS Despite rising rates of cardiogenic shock (CS), data on trends and in-hospital outcomes of short-term non-durable mechanical circulatory support (MCS) are limited. Thus, we aimed to identify recent national trends in MCS utilisation in the USA, patient-level predictors of MCS use, and in-hospital outcomes in CS inclusive of extracorporeal membrane oxygenation (ECMO). METHODS AND RESULTS Hospitalisations of US adults with a discharge diagnosis of CS, from January 2004 to December 2014, in the National Inpatient Sample were included. Rates of MCS were stratified by device type and clinical presentation. Outcomes included in-hospital mortality, hospitalisation costs, and number of procedures. A total of 183,516 hospitalisations with CS (47,636 [25.9%] involving MCS) were included. MCS recipients were younger, less frequently female, received more procedures, had higher costs, and more frequently presented with MI (MCS vs. non-MCS: 71.6% vs. 42.9%; p

Background FFR is useful in defining the physiological significance of intermediate coronary stenosis and requires induction of maximal hyperemia and measurement of pressure proximal and distal to the stenosis. Hyperemia normally is induced by either IV or IC adenosine, a medication associated with short-term side effects. IV regadenoson and IC nitroprusside have been suggested as viable alternatives. This meta-analysis aims to identify all studies comparing use of intravenous (IV) regadenoson or intracoronary (IC) nitroprusside with IV adenosine to determine differences related to the agent utilized for assessment of fractional flow reserve (FFR). Methods We searched PubMed, EMBASE, Web of Science, SCOPUS, ClinicalTrials.gov and the Cochrane Library databases for studies comparing IV regadenoson or IC nitroprusside to IV adenosine for FFR assessment. The main outcome was difference in mean FFR measurement. The main secondary outcomes were composite side-effect profile and reclassification of lesions. Results Seven studies were included in the analysis, with a total of 375 patients. Compared to IV adenosine, there was no difference in the mean FFR derived from IV regadenoson (p = 1.0) or IC nitroprusside (p = 0.48). IV regadenoson was associated with 53% lower risk of pooled side effects compared to IV adenosine (p = 0.05). IC nitroprusside was associated with 97% lower risk of pooled side effects compared to IV adenosine (p Conclusions IV regadenoson and IC nitroprusside produce similar pressure-derived FFR measurements compared to IV adenosine and have a favorable side effect profile. Both can be considered as alternative agents to IV adenosine for FFR measurement. Further clinical validation is warranted.

Incomplete revascularization is associated with worse outcomes as the number of untreated vessels increases [(1)][1]. Impella (Abiomed, Danvers, Massachusetts) and intra-aortic balloon pumps (IABP) were compared in the PROTECT-II randomized trial (A Prospective, Multi-center, Randomized

Currently, the Impella CP (Abiomed, Danvers, Massachusetts) percutaneous ventricular assist catheter requires implantation through a 14 French sheath. Additional arterial access is commonly obtained to perform therapeutic or diagnostic procedures. Multiple arterial access requires time and results in increased risk for vascular complications. Some patients may have limited arterial access. We describe the Single‐access for Hi‐risk PCI (SHiP) technique to allow for rapid and safer single access utilizing only the Impella access site. After the Impella catheter is placed in the standard fashion, a micropuncture needle is used to pierce the hemostasis valve of the Impella insertion sheath. After dilating the hemostasis valve and exchanging for a 0.035″ wire, up to a 7 French sheath can be inserted for PCI within the 14 French access sheath and alongside the 9 French portion of the Impella catheter. After PCI, the sheath is removed. We report on a case series of 17 patients using this technique. There were no instances of bleeding during the procedure or after removal of the PCI sheath, and no evidence of disruption of the Impella sheath.

Objectives Factors associated with performing urgent coronary angiography (UCA) in patients with out-of-hospital cardiac arrest (OHCA) were identified. Background Current guidelines for resuscitated OHCA patients recommend UCA if there is ST-elevation on post-arrest electrocardiogram or high suspicion of acute myocardial infarction. Some have advocated for UCA in all OHCA regardless of suspected etiology. The reasons for variations in performing UCA are not well understood. Methods A retrospective analysis of subjects presenting with resuscitated OHCA to a single academic medical center from 12/15/2007 to 8/31/2014 was conducted. Demographic and clinical characteristics of patients undergoing UCA, defined as angiography within 6 hr of presentation, were compared with those not undergoing UCA. Logistic regression was used to determine predictors of UCA. Results A total of 323 resuscitated OHCA patients (mean age, 64 years; women, 35%) were included in the analysis; 107 (33.1%) underwent coronary angiography during their hospitalization and 66 (20.4%) underwent UCA. Multivariable adjusted factors associated with UCA were ST-elevation [odds ratio (OR) 14.66, 95% confidence interval (CI) 6.28–34.24, P

Supplemental Digital Content is available in the text., Background: Patients with atrial fibrillation who undergo intracoronary stenting traditionally are treated with a vitamin K antagonist (VKA) plus dual antiplatelet therapy (DAPT), yet this treatment leads to high risks of bleeding. We hypothesized that a regimen of rivaroxaban plus a P2Y12 inhibitor monotherapy or rivaroxaban plus DAPT could reduce bleeding and thereby have a favorable impact on all-cause mortality and the need for rehospitalization. Methods: Stented subjects with nonvalvular atrial fibrillation (n=2124) were randomized 1:1:1 to administration of reduced-dose rivaroxaban 15 mg daily plus a P2Y12 inhibitor for 12 months (group 1); rivaroxaban 2.5 mg twice daily with stratification to a prespecified duration of DAPT of 1, 6, or 12 months (group 2); or the reference arm of dose-adjusted VKA daily with a similar DAPT stratification (group 3). The present post hoc analysis assessed the end point of all-cause mortality or recurrent hospitalization for an adverse event, which was further classified as the result of bleeding, a cardiovascular cause, or another cause blinded to treatment assignment. Results: The risk of all-cause mortality or recurrent hospitalization was 34.9% in group 1 (hazard ratio=0.79; 95% confidence interval, 0.66–0.94; P=0.008 versus group 3; number needed to treat=15), 31.9% in group 2 (hazard ratio=0.75; 95% confidence interval, 0.62–0.90; P=0.002 versus group 3; number needed to treat=10), and 41.9% in group 3 (VKA+DAPT). Both all-cause death plus hospitalization potentially resulting from bleeding (group 1=8.6% [P=0.032 versus group 3], group 2=8.0% [P=0.012 versus group 3], and group 3=12.4%) and all-cause death plus rehospitalization potentially resulting from a cardiovascular cause (group 1=21.4% [P=0.001 versus group 3], group 2=21.7% [P=0.011 versus group 3], and group 3=29.3%) were reduced in the rivaroxaban arms compared with the VKA arm, but other forms of rehospitalization were not. Conclusions: Among patients with atrial fibrillation undergoing intracoronary stenting, administration of either rivaroxaban 15 mg daily plus P2Y12 inhibitor monotherapy or 2.5 mg rivaroxaban twice daily plus DAPT was associated with a reduced risk of all-cause mortality or recurrent hospitalization for adverse events compared with standard-of-care VKA plus DAPT. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01830543.