Faculty Bibliography

OBJECTIVE:Compare two large-bore vascular closure devices (VCDs), collagen-plug-based MANTA and suture-based dual Perclose ProGlide (PP), in patients undergoing contemporary transfemoral transcatheter aortic valve replacement (TAVR). BACKGROUND:The SAFE MANTA IDE clinical trial demonstrated that the collagen-plug-based MANTA VCDs were safe and effective in closing large-bore arteriotomies. However, data comparing this collagen-plug-based VCD to the suture-based VCD in contemporary practice are sparse. METHODS:This was a retrospective observational study in which we screened transfemoral (TF) TAVR patients at our institution from 2017 to 2020. Included were those whose large-bore TF access was closed using either MANTA or PP with and without Angio-Seal. Our primary outcome was VCD success. Additional in-hospital outcomes included major and minor vascular complications, post-TAVR length of stay, and mortality. RESULTS:We screened 696 patients who underwent TAVR. Using propensity scores, we matched 124 patients who received MANTA with 124 patients who received PP. Patients had a mean age of 77.2 years, 69.0% were men, and their mean Society of Thoracic Surgeons score was 3.4%. VCD success was equivalent between VCDs (95.2% vs. 95.2%; p = 1.000). Patients had similar rates of mortality (0% vs. 0.8%; p = .316), and no patients had major vascular complications. CONCLUSIONS:In contemporary TAVR, the collagen-plug-based MANTA VCD appears to be as safe and effective as the suture-based dual PP VCD, with no differences in VCD success, vascular complications, or mortality. Therefore, selection of VCD for TAVR should be left to operator discretion, taking into account anatomical considerations.

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.

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.

BACKGROUND:Myocardial injury is a complication of coronavirus disease 2019 (COVID-19). We describe a large multi-center experience of COVID-19 patients with myocardial injury, examining the prognostic role left ventricular function plays on short-term outcomes. METHODS/MATERIALS:We included adult COVID-19 patients admitted to our health system with evidence of myocardial injury and who underwent a transthoracic echocardiogram (TTE) during index admission. Patients were dichotomized into those with reduced ejection fraction (EF; <50%) and preserved EF (≥50%). RESULTS:Across our 11-hospital system, 5032 adult patients were admitted with COVID-19 from March-September 2020. Of these, 235 had evidence of myocardial injury (troponin ≥1 ng/mL). Included were 134 patients who underwent TTE, of whom 43.3% (n = 58) had reduced EF and 56.7% (n = 76) preserved EF. A subset of 6 patients had newly reduced EF, with 5 demonstrating evidence of stress cardiomyopathy and subsequently dying. Overall, mortality was high in those with reduced EF and preserved EF (in-hospital: 34.5% vs. 28.9%; p = 0.494; 6 months: 63.6% vs. 50.0%; p = 0.167; Kaplan-Meier estimates: p = 0.2886). Readmissions were frequent in both groups (30 days: 22.2% vs. 26.0%; p = 0.162; 6 months: 52.0% vs. 54.5%; p = 0.839). CONCLUSIONS:Many COVID-19 patients admitted with evidence of myocardial injury did not undergo TTE. For those who did, short-term mortality was high. Patients who survived hospitalization had frequent readmissions. In patients with newly reduced EF, most had evidence of stress cardiomyopathy and expired. Larger studies are needed to fully evaluate the prognosis of COVID-19 patients with evidence of myocardial injury and left ventricular dysfunction.

BACKGROUND:Before its voluntary recall, the mechanically expandable LOTUS Edge transcatheter heart valve (THV) offered a number of unique features, notably sealing against paravalvular leak (PVL) and the ability to be fully deployed, re-captured, and re-deployed. METHODS:We performed a detailed review of all patients at our institution who underwent transcatheter aortic valve replacement (TAVR) using the LOTUS Edge THV from 2019 to 2020. We describe procedural and in-hospital outcomes. RESULTS:In brief, 59 patients underwent TAVR using the LOTUS Edge, of whom 18 were high-risk (most of whom had moderate or severe left ventricular outflow tract [LVOT] calcium), 36 were intermediate-risk enrolled in the REPRISE IV trial (one of whom had a bicuspid valve), and 5 were low-risk bicuspid patients enrolled in the LRT trial. Conduction disturbances were common (new left bundle branch block in 64.4%), with high rates of new permanent pacemaker (PPM) implantation across all risk groups (16.9%). Overall, stroke occurred in 11.9% of patients, and in 3/5 low-risk bicuspid patients, but occurred less frequently in patients with cerebral embolic protection. CONCLUSIONS:In our experience, in patients with heavy LVOT calcium burden and/or bicuspid valves, the LOTUS Edge THV offered excellent seal against PVL. However, the high rates of periprocedural stroke and new PPM implantation were a concern.

BACKGROUND:To date, there are no real-world studies comparing cangrelor to glycoprotein IIb/IIIa inhibitors (GPI) during percutaneous coronary intervention (PCI). Thus, we performed this study to evaluate the safety and effectiveness of cangrelor compared to GPI during PCI. METHODS:We identified patients who underwent PCI at our institution who received either cangrelor or GPI during PCI. Patients already on GPI or cangrelor prior to PCI or who received both cangrelor and GPI were excluded. Baseline demographics and clinical outcomes were extracted. Major bleeding is defined as a composite of major hematoma >4 cm, hematocrit drop >15, and gastrointestinal bleeding. RESULTS:A total of 2072 patients received adjunctive antiplatelet therapy during PCI (cangrelor [n=478]; GPI [n=1594]). Patients' mean age was 61±12 years. Most (66%) presented with acute coronary syndrome. Patients who received cangrelor were older and had a higher percentage of acute coronary syndrome and lower baseline hematocrit in comparison with patients who received GPI. Procedural success was achieved in 94% of patients, with no difference between groups. Major bleeding events (1.7% vs. 5.1%, P=.001), any vascular complication rates, and hospital length of stay were significantly lower in the cangrelor group. In-hospital ischemic events did not differ between groups. On regression analysis, patients on cangrelor were noted to have significantly lower major bleeding events (OR 0.23; 95% CI, 0.09-0.59). CONCLUSIONS:Balancing ischemic and bleeding risks with adjunctive antiplatelet drugs is of prime importance during PCI. Our real-world analysis shows that cangrelor is safe and effective when compared to GPI during PCI.

Background: B-type natriuretic peptide (BNP) has been established as a predictor of outcomes in patients who undergo surgical aortic valve replacement (SAVR). Studies on the prognostic value of BNP in high-risk patients undergoing transcatheter aortic valve replacement (TAVR) have yielded conflicting results. Additionally, BNP has not been well-studied in low- and intermediate-risk patients undergoing TAVR. The purpose of this study was to clarify the prognostic utility of baseline BNP in low-, intermediate-, and high-risk patients with severe aortic stenosis (AS) undergoing TAVR.
Method(s): This was a retrospective observational study of 1544 low-, intermediate-, and high-risk patients who underwent TAVR at our institution from 2012-2019. Included were patients who had a BNP <7 days prior to TAVR. Patients were then trichotomized into those with a pre-TAVR BNP <250 pg/mL (cohort 1), between 250-500 pg/mL (cohort 2), and >500 pg/mL (cohort 3). Outcomes of interest were inpatient and 30-day mortality. Statistical analyses of outcomes were performed using multivariate binary logistic regression.
Result(s): Of the 1544 patients screened, 1487 patients had a BNP level <7 days prior to TAVR and thus were included in the study. Patients in cohort 3 with a baseline BNP >500 pg/mL were 3.31 times more likely to have inpatient death (CI 0.142, 0.643; P=0.0019), 2.70 times more likely to have death within 30 days (CI 0.192, 0.711; P=0.0029) and 1.81 times more likely to have death within 1 year (CI 0.348, 0.880, p=0.0152).
Conclusion(s): Our study of 1487 low-, intermediate-, and high-risk patients demonstrates a baseline BNP greater than 500 pg/mL is an independent predictor of inpatient, 30-day and 1-year mortality. BNP has prognostic implications in TAVR patients across all risk groups and can help identify the subset of patients who may warrant closer follow up following TAVR.
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