Review of Pathophysiology of Cardiogenic Shock and Escalation of Mechanical Circulatory Support Devices.

PURPOSE OF REVIEW: Cardiogenic shock (CS) is a complex clinical entity that continues to carry a high risk of mortality. The landscape of CS management has changed with the advent of several temporary mechanical circulatory support (MCS) devices designed to provide hemodynamic support. It remains challenging to understand the role of different temporary MCS devices in patients with CS, as many of these patients are critically ill, requiring complex care with multiple MCS device options. Each temporary MCS device can provide different types and levels of hemodynamic support. It is important to understand the risk/benefit profile of each one of them for appropriate device selection in patients with CS. RECENT FINDINGS: MCS may be beneficial in CS patients through augmentation of cardiac output with subsequent improvement of systemic perfusion. Selecting the optimal MCS device depends on several variables including the underlying etiology of CS, clinical strategy of MCS use (bridge to recovery, bridge to transplant or durable MCS, or abridge to decision), amount of hemodynamic support needed, associated respiratory failure, and institutional preference. Furthermore, it is even more challenging to determine the appropriate time to escalate from one MCS device to another or combine different MCS devices. In this review, we discuss the current available data published in the literature on the management of CS and propose a standardized approach for escalation of MCS devices in patients with CS. Shock teams can play an important role to help in hemodynamic-guided management and algorithm-based step-by-step approach in early initiation and escalation of temporary MCS devices at different stages of CS. It is important to define the etiology of CS, and stage of shock and recognize univentricular vs biventricular shock for appropriate device selection and escalation of therapy.

Usefulness of Temporary Pacing in Patients With New Left Bundle Branch Block During Transcatheter Aortic Valve Implantation.

New-onset left bundle branch block (NLBBB) is the most common complication after transcatheter aortic valve implantation (TAVI). Expert consensus recommends temporary transvenous pacemaker (TTVP) support for 24 hours in these patients. To date, no study has examined TTVP use during the index hospitalization in detail. Therefore, we aimed to assess TTVP use in patients with TAVI who developed NLBBB. In this prospective observational study, we performed a detailed analysis of 24-hour telemetry in patients who developed NLBBB during TAVI. Baseline characteristics and procedural and postprocedural data were recorded. The primary outcome was pacing by the TTVP. We evaluated inappropriate TTVP use, electrophysiology study findings, permanent pacemaker (PPM) implantation, and NLBBB resolution. A total of 83 patients (74.4 ± 8.7 years, 41% female) developed NLBBB during TAVI. During index hospitalization, 1 patient (1%) required TTVP because of complete heart block and received a PPM. Five of the 83 (6%) patients were inappropriately paced, and 1 patient (1%) had ventricular fibrillation, likely secondary to TTVP. A total of 34 patients (41%) underwent electrophysiology study during hospitalization, with 4 of 83 (5%) subsequently receiving a PPM. One (1%) patient died during hospitalization, and 9 patients were lost to follow-up because of the COVID-19 pandemic. Of the remaining 73 patients with a 30-day follow-up, NLBBB had resolved in 36 (49%) at 30 days, and 2 (3%) were readmitted with complete heart block and received PPM. In conclusion, in patients with TAVI who develop NLBBB, temporary pacing is rarely necessary, may carry additional risks to the patient, and prolong hospitalization time.

Impact of Baseline Imaging of Non-Culprit Coronary Lesions on Adverse Events: Insight From LRP Study.

BACKGROUND/PURPOSE: Intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) can identify vulnerable coronary atherosclerotic plaques. We aimed to compare the presence or absence of baseline intravascular imaging of non-culprit lesions and their subsequent adverse events. METHODS/MATERIALS: We identified patients from the Lipid Rich Plaque (LRP) study who had a non-culprit-lesion adverse event and divided them into 2 cohorts: those with lesions detected with NIRS-IVUS imaging at baseline and those with lesions not imaged at baseline. RESULTS: Overall, 73 patients had an adverse event (99 coronary segments) during the 24-month follow-up period. Among them, 41 patients (56.2%) had a non-culprit-lesion adverse event related to a coronary segment imaged at baseline, and 32 patients (43.8%) had a non-culprit-lesion adverse event adjudicated to a segment that was not scanned at baseline. Angiographic core laboratory analysis suggested that unscanned lesions were more often in the right coronary artery (~50%); branches of the left coronary artery, i.e., diagonal or left obtuse marginal arteries (~20%); smaller vessels; or more tortuous vessels; and less often in the left anterior descending or distal locations. There was a weak trend for acute severe events (adjudicated myocardial infarction and acute coronary syndrome) in patients with lesions not scanned at baseline (50.0% versus 36.6%, p = 0.250). CONCLUSIONS: In patients with follow-up non-culprit-lesion adverse events, nearly half were not imaged with NIRS-IVUS at baseline. Because events related to non-imaged lesions were at least as severe as events related to imaged lesions, future clinical trials and clinical protocols should be designed to minimize this issue. CLINICAL TRIAL REGISTRATION: The Lipid-Rich Plaque Study (LRP), https://clinicaltrials.gov/ct2/show/NCT02033694, NCT02033694.

Impact of Left Ventricular Outflow Tract Calcification on Outcomes Following Transcatheter Aortic Valve Replacement.

BACKGROUND: We aimed to determine left ventricular outflow tract (LVOT) calcification impact following transcatheter aortic valve replacement (TAVR) with contemporary transcatheter heart valves. Recent studies reported a higher rate of 2-year mortality with greater than moderate LVOT calcium, but they have not established a reliable and validated method to assess the degree of valve calcification and utilized first-generation valves for their analyses. MATERIALS/METHODS: We conducted a retrospective analysis of patients who underwent TAVR at our institution from 2013 through 2017 with available valves. LVOT calcification quantification was assessed as a continuous variable. RESULTS: We included 273 patients: 179 had a non-calcified LVOT (NOLVOTCA) and 96 had a calcified LVOT (LVOTCA). Balloon post-dilatation (BPD) was utilized in 31.3% of LVOTCA vs. 19% of NOLVOTCA (p = 0.029). The Evolut R valve was used in 40.6% vs. 23.4% (p = 0.002), while the Sapien 3 was used in 59.4% vs. 76.6% (p = 0.004), for the LVOTCA and NOLVOTCA, respectively. Paravalvular leak (PVL) at hospital discharge was higher in LVOTCA (47.5%) versus NOLVOTCA (29.1%; p = 0.004). All-cause mortality (11.5% vs. 10.1%; p = 0.5) and need for permanent pacemaker implantation were similar between the groups. There was a positive trend between LVOT calcification volume and the probability of any PVL (OR 1.012; 95% CI, 0.99-1.02). CONCLUSIONS: TAVR performed in patients with calcified LVOT is safe, but LVOT calcification adversely impacts TAVR outcomes, with a higher PVL rate despite greater usage of BPD. Calcium quantification did not predict any PVL degree post-TAVR.

Contemporary post-marketing adverse events and modes of failure related to VASCADE Vascular Closure System: The utility of the MAUDE database.

OBJECTIVES: To analyze post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for the VASCADE Vascular Closure System (Cardiva Medical Inc., Santa Clara, CA). BACKGROUND: The VASCADE Vascular Closure System is a closure device for femoral arterial and venous access-site closure that was approved by the FDA in 2013. However, post-marketing data and experience on the most commonly reported complications and modes of failure associated with the VASCADE Vascular Closure System are limited. METHODS: Post-marketing surveillance data from the FDA MAUDE database from October 2013 through March 2020 were analyzed, yielding 201 reports. RESULTS: Of the 201 reports of major complications involving VASCADE devices, 156 reports involved either injury (145) or death (11) related to the device. Of the 145 injury reports, bleeding was the most common adverse outcome described (85), followed by pseudoaneurysm (29) and pulselessness of an extremity (21). The device malfunction incidents (41 reports) were reported in three main categories, with deployment failure being the most commonly reported complication. CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in contemporary post-marketing practice, physicians should be well-trained and educated to use the VASCADE closure device because improper utilization is a common cause of device failure, and complications with the VASCADE device can have profound clinical implications.

Right transradial coronary angiography in the setting of tortuous brachiocephalic/thoracic aorta ("elephant head"): Impact on fluoroscopy time and contrast use.

OBJECTIVES: Assess the impact on fluoroscopy time and contrast use in patients with tortuous brachiocephalic/thoracic aortas undergoing right transradial coronary angiography (RTCA) and provide strategies to manage. BACKGROUND: Unfavorable anatomy with severe brachiocephalic/thoracic tortuosity, referred to as an "elephant head," remains a significant obstacle for RTCA. METHODS: We reviewed the coronary angiograms of patients who underwent RTCA and had tortuous aortas. Angiography was attempted first using a universal catheter (Tiger) and switched to a left coronary specific catheter (Judkins Left [JL]) if challenging. Fluoroscopy time, contrast volume, and greatest distance from the patient's midline to the catheter in the aorta were recorded. RESULTS: Forty-nine patients (62.6 ± 12.0 years, 69.4% male) were included. Fifteen (30.6%) patients underwent successful angiography with a Tiger catheter; 34 (69.4%) patients required switching to JL catheter. The average distance of Tiger catheters to the midline of the spine was 0.78 ± 0.41 cm versus 1.28 ± 0.44 cm (p = .001) in JL catheters. Tiger catheter use resulted in less fluoroscopy time (6.48 ± 4.73 min) and contrast use (58.87 ± 43.53 ml) than in cases switched to JL (13.26 ± 10.76 min [p = .026]; 86.5 ± 69.95 ml [(p = .017]). CONCLUSIONS: For patients undergoing RTCA with significant brachiocephalic/thoracic aorta tortuosity, "elephant head," a Tiger catheter can be used efficiently for curvatures <1 cm from the middle of the spine. We propose that for curvatures >1 cm, operators should consider immediately switching to a JL catheter.

Comparison of Outcomes in Patients With COVID-19 and Thrombosis Versus Those Without Thrombosis.

The occurrence of venous thromboembolisms in patients with COVID-19 has been established. We sought to evaluate the clinical impact of thrombosis in patients with COVID-19 over the span of the pandemic to date. We analyzed patients with COVID-19 with a diagnosis of thrombosis who presented to the MedStar Health system (11 hospitals in Washington, District of Columbia, and Maryland) during the pandemic (March 1, 2020, to March 31, 2021). We compared the clinical course and outcomes based on the presence or absence of thrombosis and then, specifically, the presence of cardiac thrombosis. The cohort included 11,537 patients who were admitted for COVID-19. Of these patients, 1,248 had noncardiac thrombotic events and 1,009 had cardiac thrombosis (myocardial infarction) during their hospital admission. Of the noncardiac thrombotic events, 562 (45.0%) were pulmonary embolisms, 480 (38.5%) were deep venous thromboembolisms, and 347 (27.8%) were strokes. In the thrombosis arm, the mean age of the cohort was 64.5 ± 15.3 years, 53.3% were men, and the majority were African-American (64.9%). Patients with thrombosis tended to be older with more co-morbidities. The in-hospital mortality rate was significantly higher (16.0%) in patients with COVID-19 with concomitant non-cardiac thrombosis than in those without thrombosis (7.9%, p <0.001) but lower than in patients with COVID-19 with cardiac thrombosis (24.7%, p <0.001). In conclusion, patients with COVID-19 with thrombosis, especially cardiac thrombosis, are at higher risk for in-hospital mortality. However, this prognosis is not as grim as for patients with COVID-19 and cardiac thrombosis. Efforts should be focused on early recognition, evaluation, and intensifying antithrombotic management for these patients.

High-Risk Percutaneous Coronary Intervention of Native Coronary Arteries Without Mechanical Circulatory Support in Acute Coronary Syndrome Without Cardiogenic Shock.

Widespread utilization of mechanical circulatory support (MCS) for high-risk percutaneous coronary intervention (PCI) remains controversial, with a lack of randomized supporting evidence and associated risk of device-related complications. We investigated whether high-risk PCI of native coronary arteries without elective MCS in patients with acute coronary syndrome (ACS) is safe and feasible. We performed a single-center, retrospective analysis for ACS patients meeting American College of Cardiology high-risk criteria: unprotected left main disease, last remaining conduit, ejection fraction <35%, 3-vessel coronary artery disease, severe aortic stenosis, or severe mitral regurgitation. Patients with cardiogenic shock and those undergoing PCI of the bypass grafts were excluded. Major in-hospital and 30-day cardiovascular outcomes were assessed. From 2003 through 2018, 499 patients (847 lesions) with unstable angina pectoris (UAP), 1218 patients (1807 lesions) with non-ST-elevation myocardial infarction (NSTEMI), and 868 patients (1260 lesions) with ST-segment elevation myocardial infarction (STEMI) underwent high-risk PCI. Procedural success was achieved in 97.2% of UAP, 98.3% of NSTEMI, and 96.6% of STEMI patients. In-hospital and 30-day all-cause mortality were as follows: UAP, 2%; NSTEMI, 2.1%; and STEMI 4.7%. Bailout intra-aortic balloon pump was required in 1.6% of UAP, 3.1% of NSTEMI, and 10.3% of STEMI patients. Major complications for UAP, NSTEMI, and STEMI were, respectively: target lesion revascularization (2.3%, 1.4%, and 1.5%), stroke or transient ischemic attack (0.8%, 0.6%, and 1.3%), acute renal failure (8.2%, 7.2%, and 10.2%), major bleeding (1.6%, 3.1%, and 8.5%). In conclusion, our results show that high-risk PCI without elective MCS is safe and feasible in most ACS patients, challenging professional societies' current recommendations. A randomized trial comparing unprotected versus protected high-risk PCI for non-shock ACS patients is warranted.

Evolution of Management and Outcomes of Patients with Myocardial Injury During the COVID-19 Pandemic.

Cardiac involvement in coronavirus disease 2019 (COVID-19) has been established. This is manifested by troponin elevation and associated with worse patient prognosis. We evaluated whether patient outcomes improved as experience accumulated during the pandemic. We analyzed COVID-19-positive patients with myocardial injury (defined as troponin elevation) who presented to the MedStar Health system (11 hospitals in Washington, DC, and Maryland) during the "Early Phase" of the pandemic (March 1 - June 30, 2020) and compared their characteristics and outcomes to the COVID-19-positive patients with the presence of troponin elevation in the "Later Phase" of the pandemic (October 1, 2020 - January 31, 2021). The cohort included 788 COVID-19-positive admitted patients for whom troponin was elevated, 167 during the "Early Phase" and 621 during the "Later Phase." Maximum troponin-I in the "Early Phase" was 13.46±34.72 ng/mL versus 11.21±20.57 ng/mL in the "Later Phase" (p = 0.553). In-hospital mortality was significantly higher in the "Later Phase" (50.3% vs. 24.6%; p<0.001), as were incidence of intensive-care-unit admission (77.8% vs. 46.1%; p<0.001) and need for mechanical ventilation (61.7% versus 28%; p<0.001). In addition, more "Early Phase" patients underwent coronary angiography (6% vs. 2.3%; p=0.013). Finally, 3% of "Early Phase" and 0.8% of "Later Phase" patients underwent percutaneous coronary intervention (p=0.025). In conclusion, treatment outcomes have significantly improved since the beginning of the pandemic in COVID-19-positive patients with troponin elevation. This may be attributed to awareness, severity of the disease, improvements in therapies, and provider experience.

Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients: Meta-Analysis.

BACKGROUND: Most pivotal transcatheter aortic valve replacement (TAVR) trials have excluded patients with bicuspid aortic stenosis (AS). This study compared TAVR in low-risk patients with bicuspid AS to those with tricuspid AS, incorporating data from prospective trials. METHODS: We selected prospective US low-risk TAVR trials containing a bicuspid arm for this meta-analysis, examining outcomes at 30 days. Study results were pooled using a hierarchical Bayesian random-effects model. RESULTS: Included were 3 Food and Drug Administration (FDA)-approved investigational device exemption (IDE) trials that enrolled a total of 1810 low-risk patients with symptomatic severe AS for TAVR. We compared 380 bicuspid patients with 1430 tricuspid patients. Event rates at 30 days overall were low, with similar mortality (odds ratio [OR], 0.38; 95% credible interval [CrI]: 0.08, 1.78; I2, 0%), non-disabling stroke (OR, 0.45; 95% CrI: 0.15, 1.07; I2, 9%), and permanent pacemaker implantation (OR, 0.86; 95% CrI: 0.41, 1.47; I2, 59%). There were statistically significant differences in disabling stroke (OR, 0.16; 95% CrI: 0.01, 0.90; I2, NA) and coronary obstruction (OR, 0.21; 95% CrI: 0.05, 0.91) that disappeared after sensitivity analysis by adding a single event to the tricuspid arm. Hemodynamics were similar at 30 days. CONCLUSIONS: Preliminary data from the FDA-approved IDE trials of low-risk patients with bicuspid AS undergoing TAVR demonstrated 30-day outcomes comparable to low-risk tricuspid patients, except for a trend toward higher stroke in bicuspid patients. Randomized trials are warranted to reassure the safety and long-term outcome of TAVR in patients with severe bicuspid AS.

Meta-Analysis of Usefulness of Antiplatelet Therapy in Ischemic Stroke or Transient Ischemic Attack.

The efficacy of early administration of dual antiplatelet therapy (DAPT) for secondary prevention after acute ischemic stroke or transient ischemic attack (TIA) is uncertain. This systematic review and meta-analysis compares the safety and efficacy of early administration (<24 hours) of DAPT (using either clopidogrel or ticagrelor with aspirin) versus single antiplatelet therapy (SAPT; aspirin alone) in acute non-cardioembolic ischemic stroke or TIA, incorporating data from large randomized controlled trials. Published trials fulfilling our criteria were identified from an electronic search of MEDLINE, with key words including: "clopidogrel or ticagrelor", "aspirin", "ischemic stroke", "transient ischemic attack", and "randomized controlled trial". Included were 3 randomized controlled trials of 21,067 patients assessing early administration (<24 hours from symptom onset) of DAPT versus SAPT in non-cardioembolic acute ischemic stroke or TIA. Our efficacy outcomes were ischemic stroke and all-cause mortality. Our safety outcome was severe bleeding. We performed a meta-analysis to pool results with a hierarchical Bayesian random-effects model. Dual antiplatelet therapy significantly reduced the risk of ischemic stroke (hazard ratio [HR], 0.73; 95% credible interval [CrI]: 0.54, 0.97), while increasing the risk of severe bleeding (HR, 2.48; 95% CrI: 1.07, 5.26). There was a non-significant numerical trend toward increased mortality with DAPT (HR, 1.29; 95% CrI: 0.73, 2.23). These observations were robust under the sensitivity analysis. In the present systematic review and meta-analysis of randomized controlled trials, DAPT reduced the risk of ischemic stroke at the cost of an increase in severe bleeding. Additional trials examining the ideal timing of DAPT administration are needed to thoroughly investigate the role, if any, of routine DAPT in patients with non-cardioembolic ischemic stroke or high-risk TIA.

Transcatheter Versus Surgical Aortic Valve Replacement in Young, Low-Risk Patients With Severe Aortic Stenosis.

Transcatheter aortic valve replacement (TAVR) is approved for all patient risk profiles and is an option for all patients irrespective of age. However, patients enrolled in the low- and intermediate-risk trials were in their 70s, and those in the high-risk trials were in their 80s. TAVR has never been systematically tested in young (<65 years), low-risk patients. Unanswered questions remain, including the safety and effectiveness of TAVR in patients with bicuspid aortic valves; future coronary access; durability of transcatheter heart valves; technical considerations for surgical transcatheter heart valve explantation; management of concomitant conditions such as aortopathy, mitral valve disease, and coronary artery disease; and the safety and feasibility of future TAVR-in-TAVR. The authors predict that balancing these questions with patients' clear preference for less invasive treatment will become common. In this paper, the authors consider each of these questions and discuss risks and benefits of theoretical treatment strategies in the lifetime management of young patients with severe aortic stenosis.

Balloon-Expandable Valve Geometry After Transcatheter Aortic Valve Replacement in Low-Risk Patients With Bicuspid Versus Tricuspid Aortic Stenosis.

BACKGROUND: Prospective bicuspid low-risk transcatheter aortic valve replacement (TAVR) registries' data demonstrated encouraging short-term results. Detailed data on transcatheter heart valve (THV) geometry after deployment using contemporary devices are lacking. This study sought to examine valve geometry after TAVR in patients with bicuspid aortic stenosis (AS). METHODS: The study population was patients from the LRT (Low Risk TAVR) trial who underwent TAVR using the SAPIEN 3 THV for bicuspid and tricuspid AS. THV geometry measured on 30-day computed tomography (CT) included valve height, angle, depth, and eccentricity. Additionally, THV hemodynamics and outcomes post-TAVR were compared among patients with bicuspid and tricuspid AS. RESULTS: A total of 107 patients from the LRT trial using the SAPIEN 3 THV were included in our analysis. On 30-day CT, the valve height ratio (1.07 vs. 1.07; p = 0.348), depths (right [5.6 mm vs. 6.2 mm; p = 0.223], left [5.3 mm vs. 4.4 mm; p = 0.082] and non [4.8 mm vs. 4.5 mm; p = 0.589] coronary cusps), eccentricities (1.08 vs. 1.07; p = 0.9550), and angles (except the right [3.9 degrees vs. 6.3 degrees; p = 0.003] and left [3.6 degrees vs. 6.0 degrees; p = 0.007]) were similar between bicuspid and tricuspid patients. Hemodynamics, stroke, and mortality were similar at 1 year. CONCLUSION: Despite challenging bicuspid anatomy of the aortic valve, our comprehensive CT analysis supports similar THV geometry between patients with bicuspid and tricuspid AS undergoing TAVR using the SAPIEN 3 THV in low-risk patients. This translated to excellent short-term clinical outcomes and THV hemodynamics in both aortic valve morphologies. TRIAL REGISTRY: NCT02628899, https://clinicaltrials.gov/ct2/show/NCT02628899.

Pre-Operative Cardiovascular Testing before Liver Transplantation.

End-stage liver disease (ESLD) is increasingly prevalent and shares many risk factors with coronary artery disease (CAD). No specific guidelines exist for pre-liver transplant evaluation of CAD, and pretransplant cardiovascular testing varies widely. The aim of this study is to characterize pre-transplant cardiac testing practices with post-transplant clinical outcomes. We retrospectively reviewed patients undergoing initial liver transplantation at our transplant center between January 2015 and March 2019. Patients with previous liver transplantation or multi-organ transplantation were excluded. Electronic medical records were reviewed for relevant demographic and clinical data. We included 285 patients with a mean follow-up of 2.4 years. Of 274 patients (96.1%) with pre-transplant transthoracic echocardiogram (TTE), 18 (6.6%) were abnormal. Non-invasive ischemic testing was performed in 193 (68%) patients: 165 (58%) underwent stress TTE, 24 (8%) underwent myocardial perfusion imaging, 3 underwent coronary computed tomography, and 1 underwent exercise electrocardiogram. Sixteen patients (6%) had left heart catheterization of which 10 (63%) were abnormal and 5 proceeded to revascularization before transplant. There were 4 (1.4%) deaths within 30 days of transplant and 23 deaths (8.1%) in total. ST-elevation myocardial infarction was seen in 1 patient within 30 days and 1 patient after 30 days (0.7% total). No cardiovascular deaths were observed. Among patients undergoing liver transplantation, pre-transplantation cardiovascular testing is exceedingly common and post-transplant cardiovascular complications are rare. Additional research is needed to determine the optimal testing and surveillance in this patient population.

The Impact of COVID-19 Patients With Troponin Elevation on Renal Impairment and Clinical Outcome.

BACKGROUND: Cardiac involvement in coronavirus disease 2019 (COVID-19) is known, manifested by troponin elevation, and these patients have a worse prognosis than patients without myocardial injury. METHODS: We analyzed COVID-19-positive patients who presented to the MedStar Health system (11 hospitals in Washington, DC, and Maryland) during the pandemic (March 1-September 30, 2020). We compared renal function and subsequent in-hospital clinical outcomes based on the presence or absence of troponin elevation. The primary outcome was the incidence of acute kidney injury in COVID-19 patients with troponin elevation. We also evaluated in-hospital mortality, overall and based on the presence and absence of both troponin elevation and renal dysfunction. RESULTS: The cohort included 3386 COVID-19-positive admitted patients for whom troponin was drawn. Of these patients, 195 had troponin elevation (defined as ≥1.0 ng/mL), mean age was 61 ± 16 years, and 51% were men. In-hospital mortality was significantly higher (53.8%) in COVID-19-positive patients with concomitant troponin elevation than in those without troponin elevation (14.5%; p < 0.001). COVID-19-positive patients with troponin elevation had a higher prevalence of renal dysfunction (58.5%) than those without troponin elevation (23.4%; p < 0.001). Further analysis demonstrated that having both troponin elevation and renal dysfunction carried the worst in-hospital prognosis (in-hospital mortality 57.9%; intensive-care-unit admission 76.8%; ventilation requirement 63.2%), as compared to the absence or presence of either. CONCLUSION: COVID-19 patients with troponin elevation are at higher risk for worsening renal function, and these patients subsequently have worse in-hospital clinical outcomes. Efforts should focus on early recognition, evaluation, and intensifying care of these patients.

A Patient-Level, Pooled Analysis of Mortality Rates With the Passeo-18 Lux Paclitaxel Drug-Coated Balloon in Peripheral Arterial Disease.

BACKGROUND: Recent meta-analyses have raised concerns about mortality with paclitaxel drug-coated balloons (DCB). This pooled, patient-level analysis of the BIOLUX P-I, P-II, and P-III studies was performed to evaluate the safety and efficacy of Passeo-18 Lux DCB. MATERIALS AND METHODS: Individual patient-level demographic, clinical, diagnostic, and procedural data from the BIOLUX P-I, BIOLUX P-II, and BIOLUX P-III studies were pooled in a common database. Clinical safety (all-cause mortality and cardiovascular mortality) and efficacy (any amputation, target lesion/vessel revascularization) were extracted. Cox proportional modeling was used to assess the effect of critical limb ischemia at the time of enrollment and the occurrence of new amputation as a time-dependent variable on mortality. RESULTS: A total of 1009 patients were included in the analysis. Sixty-six patients were treated with percutaneous transluminal angioplasty (PTA) and 943 underwent DCB angioplasty. The cumulative incidence of all-cause mortality did not differ between the groups (PTA 6.7%, DCB 6.7%, p = 0.65). The composite efficacy endpoint of freedom from any amputation and target lesion/vessel revascularization was superior in the DCB arm compared to PTA [PTA 28.8%, DCB 16.7%, p = 0.02]. Both in unadjusted and adjusted Cox proportional models (adjusted for critical limb ischemia and amputation), the use of DCB was not associated with any mortality at 1 year. CONCLUSIONS: Our patient-level analysis shows that overall, the use of the Passeo-18 Lux paclitaxel DCB in infrainguinal arteries was not associated with increased mortality at 1 year and reinforces the efficacy of DCB angioplasty in preventing amputation or the need for reintervention.

Clinical Impact and Predictors of Troponin Elevation in Patients With COVID-19.

BACKGROUND: Cardiac involvement in coronavirus disease 2019 (COVID-19) is known, manifested by troponin elevation. Studies in the initial phase of the pandemic demonstrated that these patients tended to have a worse prognosis than patients without myocardial injury. We sought to evaluate the clinical impact of significant troponin elevation in COVID-19-positive patients, along with predictors of poor outcomes, over the span of the pandemic to date. METHODS: We analyzed COVID-19-positive patients who presented to the MedStar Health system (11 hospitals in Washington, DC, and Maryland) during the pandemic (March 1-June 30, 2020). We compared clinical course and outcomes based on the presence of troponin elevation and identified predictors of mortality. RESULTS: The cohort included 2716 COVID-19-positive admitted patients for whom troponin was drawn. Of these patients, 250 had troponin elevation (≥1.0 ng/mL). In the troponin-elevation arm, the minimum troponin level was 1.9 ± 8.82 ng/mL; maximum elevation was 10.23 ± 31.07 ng/mL. The cohort's mean age was 68.0 ± 15.0 years; 52.8% were men. Most (68.5%) COVID-19-positive patients with troponin elevation were African American. Patients with troponin elevation tended to be older, with more co-morbidities, and most required mechanical ventilation. In-hospital mortality was significantly higher (48.4%) in COVID-19-positive patients with concomitant troponin elevation than without troponin elevation (12.2%; p < 0.001). CONCLUSION: COVID-19 patients with troponin elevation are at higher risk for mechanical ventilation and mortality. Efforts should focus on early recognition, evaluation, and intensifying care of these patients.