The coronavirus disease‐2019 (COVID‐19) pandemic has strained health care resources around the world, causing many institutions to curtail or stop elective procedures. This has resulted in an ...inability to care for patients with valvular and structural heart disease in a timely fashion, potentially placing these patients at increased risk for adverse cardiovascular complications, including CHF and death. The effective triage of these patients has become challenging in the current environment, as clinicians have had to weigh the risk of bringing susceptible patients into the hospital environment during the COVID‐19 pandemic against the risk of delaying a needed procedure. In this document, the authors suggest guidelines for how to triage patients in need of structural heart disease interventions and provide a framework for how to decide when it may be appropriate to proceed with intervention despite the ongoing pandemic. In particular, the authors address the triage of patients in need of transcatheter aortic valve replacement and percutaneous mitral valve repair. The authors also address procedural issues and considerations for the function of structural heart disease teams during the COVID‐19 pandemic.
This study sought to explore the association between biomarker elevation, with creatine kinase–myocardial band (CK-MB) or cardiac troponin (cTn), following percutaneous coronary intervention (PCI) ...and mortality in patients undergoing PCI for stable angina with normal baseline values.
Several studies have shown a strong association between post-PCI CK-MB elevation and subsequent mortality. However, the prognostic significance of troponin elevation following coronary intervention is still debated.
Patient-level data from 5 contemporary coronary stent trials and 1 large registry were pooled. Mortality of patients with stable angina, with normal baseline biomarkers, was compared between patients with and those without different cutoff values of cTn and CK-MB.
A total of 13,452 patients were included in this pooled analysis. The overall percentage of patients with elevated biomarkers following PCI was 23.9% for CK-MB and 68.4% for cTn. In the patient cohort for whom both assays were available (n = 8,859), 2.4% had both CK-MB ≥5 × the upper limit of normal (ULN) and cTn ≥35 × ULN, while 92% had both CK-MB <5 × ULN and cTn <35 × ULN. Among patients with CK-MB ≥5 × ULN (n = 315), 212 (67.3%) also had cTn ≥35 × ULN. Conversely, 390 of patients (64.8%) who had cTn ≥35 × ULN did not have CK-MB ≥5 × ULN. A total of 259 patients (1.9%) died at 1 year; 20 (7.7%) had CK-MB ≥5 × ULN, and 23 (8.8%) had cTn ≥35 × ULN. In the Cox multivariate analysis, in which the CK-MB and cTn ratios post-procedure were forced into the model, age, prior myocardial infarction, lesion complexity, hyperlipidemia, and CK-MB ratio (≥10) post-procedure were associated with increased 1-year mortality.
Following elective PCI in patients in stable condition treated with second-generation drug-eluting stent, CK-MB and cTn elevations remain common. After multivariate adjustment, there was an increased mortality rate with elevation of CK-MB after PCI, whereas cTn elevation was not independently associated with mortality at 1 year.
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Abstract
BACKGROUND
Robotic-assistance in endovascular intervention represents a nascent yet promising innovation.
OBJECTIVE
To present the first human experience utilizing robotic-assisted ...angiography in the extracranial carotid circulation.
METHODS
Between March 2019 and September 2019, patients with extracranial carotid circulation pathology presenting to Houston Methodist Hospital were enrolled.
RESULTS
A total of 6 patients met inclusion criteria: 5 underwent diagnostic angiography only with robotic-assisted catheter manipulation, while 1 underwent both diagnostic followed by delayed therapeutic intervention. Mean age was 51 +/− 17.5 yr. Mean anesthesia time was 158.7 +/− 37.9 min, mean fluoroscopic time was 22.0 +/− 7.3 min, and mean radiation dose was 815.0 +/− 517.0 mGy. There were no technical complications and no clinical deficits postprocedure. None of the cases required conversion to manual neurovascular intervention (NVI).
CONCLUSION
Incorporating robotic technology in NVI can enhance procedural technique and diminish occupational hazards. Its application in the coronary and peripheral vascular settings has established safety and efficacy, but in the neurovascular setting, this has yet to be demonstrated. This study presents the first in human feasibility experience of robotic-assisted NVI in the extracranial carotid circulation.
Role of Reticulated Platelets and Platelet Size Heterogeneity on Platelet Activity After Dual Antiplatelet Therapy With Aspirin and Clopidogrel in Patients With Stable Coronary Artery Disease ...Sasidhar Guthikonda, Carlos L. Alviar, Muthiah Vaduganathan, Mehmet Arikan, Armando Tellez, Timothy DeLao, Juan F. Granada, Jing-Fei Dong, Neal S. Kleiman, Eli I. Lev Reticulated platelets (RPs) are possibly more active than non-RPs. The relationship among platelet size, number of RPs, and platelet function in patients with stable coronary artery disease taking both aspirin and clopidogrel was evaluated. Patients with a higher percentage of RPs displayed significantly higher platelet activation and aggregation and had a higher prevalence of low response to aspirin, clopidogrel, and both. Large platelets have a significantly higher percentage of RPs as well as higher platelet activation determined by activated glycoprotein IIb/IIIa and P-selectin expression.
Objectives This study evaluated the feasibility, tolerability, and efficacy of a strategy for percutaneous intra-aortic balloon pump (IABP) placement through the left axillary-subclavian artery to ...provide mechanical circulatory support in patients with end-stage heart failure as a bridge to heart transplantation. Background The transfemoral approach to IABP placement is associated with major disadvantages, including the risk for infection and limitation of patient mobility in those requiring extended support. Methods We developed a percutaneous technique for placing IABPs in the left axillary artery that permits upright sitting and ambulation. We performed a retrospective review of data from patients who had undergone left axillary IABP implantation between 2007 and 2012. Results Fifty patients who received a left axillary IABP as a bridge to transplantation were identified, of whom 42 (84%) underwent heart or heart–multiorgan transplantation. Cumulative survival on IABP support was 92%, and post-transplant 90-day survival was 90%. Median duration of support was 18 days. Four of 50 patients (8%) died while on IABP support, and 3 (6%) received greater mechanical circulatory support. Four patients (8%) had clinically significant thromboembolic or bleeding events without long-term sequelae. The most common minor adverse event was IABP malposition, in 22 patients (44%). Prolonged IABP support in the heart-transplantation cohort was associated with significant improvements in mean pulmonary artery pressure and in creatinine and total bilirubin concentrations. Conclusions Percutaneous insertion of an IABP through the left axillary artery is a feasible and relatively well-tolerated strategy to bridge patients with end-stage heart failure to heart transplantation. This form of mechanical-device treatment permits upright sitting and ambulation in those requiring extended support.
Transcatheter aortic valve replacement (TAVR) is established for selected patients with severe aortic stenosis. However, limitations such as suboptimal deployment, conduction disturbances, and ...paravalvular leak occur.
To evaluate if a mechanically expanded valve (MEV) is noninferior to an approved self-expanding valve (SEV) in high-risk patients with aortic stenosis undergoing TAVR.
The REPRISE III trial was conducted in 912 patients with high or extreme risk and severe, symptomatic aortic stenosis at 55 centers in North America, Europe, and Australia between September 22, 2014, and December 24, 2015, with final follow-up on March 8, 2017.
Participants were randomized in a 2:1 ratio to receive either an MEV (n = 607) or an SEV (n = 305).
The primary safety end point was the 30-day composite of all-cause mortality, stroke, life-threatening or major bleeding, stage 2/3 acute kidney injury, and major vascular complications tested for noninferiority (margin, 10.5%). The primary effectiveness end point was the 1-year composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak tested for noninferiority (margin, 9.5%). If noninferiority criteria were met, the secondary end point of 1-year moderate or greater paravalvular leak was tested for superiority in the full analysis data set.
Among 912 randomized patients (mean age, 82.8 SD, 7.3 years; 463 51% women; predicted risk of mortality, 6.8%), 874 (96%) were evaluable at 1 year. The primary safety composite end point at 30 days occurred in 20.3% of MEV patients and 17.2% of SEV patients (difference, 3.1%; Farrington-Manning 97.5% CI, -∞ to 8.3%; P = .003 for noninferiority). At 1 year, the primary effectiveness composite end point occurred in 15.4% with the MEV and 25.5% with the SEV (difference, -10.1%; Farrington-Manning 97.5% CI, -∞ to -4.4%; P<.001 for noninferiority). The 1-year rates of moderate or severe paravalvular leak were 0.9% for the MEV and 6.8% for the SEV (difference, -6.1%; 95% CI, -9.6% to -2.6%; P < .001). The superiority analysis for primary effectiveness was statistically significant (difference, -10.2%; 95% CI, -16.3% to -4.0%; P < .001). The MEV had higher rates of new pacemaker implants (35.5% vs 19.6%; P < .001) and valve thrombosis (1.5% vs 0%) but lower rates of repeat procedures (0.2% vs 2.0%), valve-in-valve deployments (0% vs 3.7%), and valve malpositioning (0% vs 2.7%).
Among high-risk patients with aortic stenosis, use of the MEV compared with the SEV did not result in inferior outcomes for the primary safety end point or the primary effectiveness end point. These findings suggest that the MEV may be a useful addition for TAVR in high-risk patients.
ClinicalTrials.gov Identifier: NCT02202434.
Intracoronary imaging has become an important tool in the treatment of complex lesions with percutaneous coronary intervention (PCI). This retrospective cohort study identified 1,118,475 patients ...with PCI from the Nationwide Readmissions Database from 2017 to 2019. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) were identified with appropriate International Classification of Diseases, Tenth Revision codes. The primary outcome was major adverse cardiac events. The secondary outcomes include net adverse clinical events (NACEs), all-cause mortality, myocardial infarction (MI) readmission, admission for stroke, and emergency revascularization. The multivariate Cox proportional hazard regression was used to adjust for demographic and co-morbid confounders. Of 1,118,475 PCIs, 86,140 (7.7%) used IVUS guidance and 5,617 (0.5%) used OCT guidance. The median follow-up time was 184 days. The primary outcome of major adverse cardiac events was significantly lower for the IVUS (6.5% vs 7.6%; hazard ratio HR 0.89, 95% confidence interval CI 0.86 to 0.91, p <0.001) and OCT (4.4% vs 7.6%; HR 0.69, 95% CI 0.61 to 0.79, p <0.001) groups. IVUS was associated with significantly lower rates of NACEs (8.4% vs 9.4%; HR 0.92, 95% CI 0.89 to 0.94, p <0.001), all-cause mortality (3.5% vs 4.3%; HR 0.85, 95% CI 0.82 to 0.88, p <0.001), readmission for MI (2.7% vs 3.0%; HR 0.95, 95% CI 0.91 to 0.99, p = 0.012), and admission for stroke (0.5% vs 0.6%; HR 0.86, 95% CI 0.78 to 0.95, p = 0.002). OCT was associated with significantly lower rates of NACEs (6.6% vs 9.4%; HR 0.81, 95% CI 0.73 to 0.89, p <0.001) and all-cause mortality (1.8% vs 4.3%; HR 0.51, 95% CI 0.42 to 0.63, p <0.001). Emergency revascularization was not significantly different with IVUS guidance. Readmission for MI, stroke, and emergency revascularization were not significantly different with OCT guidance. A subgroup analysis of patients with ST-elevation MI and non–ST-elevation MI showed similar results. In conclusion, the use of IVUS and OCT guidance with PCI were associated with significantly lower rates of morbidity and mortality in real-world practice.
Clinical trials that have excluded patients at high risk for cardiac events have led to commercial labeling approval of drug-eluting stents; nevertheless, such high-risk patients commonly undergo ...stent placement in clinical practice. The degree to which they experience cardiac events at a higher rate than non-high-risk patients is unclear.
To assess the rates of major adverse cardiac events during the index admission and 1 year after the implantation of drug-eluting stents in patients with high-risk angiographic and clinical features.
From July 2004 to September 2005, consecutive patients who underwent attempted stent placement at 42 different hospitals throughout the United States were enrolled in a prospective multicenter registry. We analyzed outcomes of 3323 patients who received at least 1 drug-eluting stent for a reason other than acute ST-segment elevation myocardial infarction. The study population was divided into 2 groups based on presence of at least 1 of 9 off-label characteristics based on the current US Food and Drug Administration-approved indications for sirolimus- and paclitaxel-eluting stents.
The composite clinical outcomes of death, myocardial infarction, or target vessel revascularization during the index admission and death, myocardial infarction, or target lesion revascularization at 1 year were evaluated.
Of the 3323 patients, 1817 (54.7%) had at least 1 off-label characteristic. During the index hospitalization, the composite clinical outcome occurred in 198 (10.9%) of patients in the off-label group and 76 (5.0%) of patients in the on-label group (adjusted odds ratio, 2.32; 95% confidence interval CI, 1.75-3.07; P<.001). At 1 year, the composite clinical outcome occurred more often in the off-label group compared with the on-label group; 309 (17.5%) vs 131 (8.9%) (adjusted hazard ratio HR, 2.16; 95% CI, 1.74-2.67; P<.001). Stent thrombosis also occurred more frequently among patients in the off-label group during the initial hospitalization (8 0.4% vs 0) and at 1 year: 29 (1.6%) vs 13 (0.9%), adjusted HR, 2.29 (95% CI, 1.02-5.16; P = .05).
Compared with on-label use, off-label use of drug-eluting stents is associated with a higher rate of adverse outcomes during the index admission and at 1 year. Stent thrombosis occurred predominantly in patients who underwent off-label drug-eluting stent implantation. Clinicians should be cautious about extrapolating the benefits of drug-eluting stents over bare-metal stents observed in randomized clinical trials to higher-risk clinical settings that have not been assessed.
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