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.
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.
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).
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.
Display omitted In-hospital ischemic and bleeding events in cangrelor vs. glycoprotein IIb/IIIa inhibitors.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objectives
We analyzed post‐marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture‐based ...vascular closure devices (VCDs) – Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott).
Background
Suture‐based VCDs are mostly used for large‐bore femoral arterial access‐site closure. Real‐world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited.
Methods
Post‐marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports.
Results
Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture‐related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group.
Conclusions
Our analysis of the MAUDE database demonstrates that in real‐world practice, suture‐based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre‐procedural patient selection are important to minimize risks associated with suture‐based vascular closure devices.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Left ventricular outflow tract (LVOT) calcium remains a challenge for transcatheter aortic valve implantation (TAVI) and is associated with an increased risk of debris embolization, permanent ...pacemaker requirement, and annular rupture. We report the results of the (EPROMPT) CoreValve Evolut PRO Prospective Registry, which sought to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter heart valve (THV) according to computed tomography-defined extent of LVOT calcium. The prospective, investigator-initiated, multicenter registry includes patients who underwent TAVI using the CoreValve Evolut PRO/PRO+ THV system. Analyzed patients were dichotomized on the basis of the severity of their LVOT calcium at baseline (none/mild vs moderate/severe). Patients were followed with 30-day clinical assessment and echocardiography. Of the 277 patients included, 177 had computed tomography-defined none/mild LVOT calcium (63.9%), and 100 had moderate/severe LVOT calcium (36.1%). Device success was similar in both cohorts (97.7% vs 95.0%; p = 0.217). Stroke rates were numerically higher in the moderate/severe LVOT calcium cohort (in-hospital and 30 day: 1.7% vs 4.0%; p = 0.240). Patients with none/mild LVOT calcium had higher rates of permanent pacemaker implantation (in-hospital: 21.5% vs 9.0%; p = 0.008 and 30-day: 22.0% vs 12.0%; p = 0.027). At 30 days, there were numerically higher rates of >mild paravalvular leak in patients with moderate/severe LVOT calcium (1.7% vs 4.0%; p = 0.240). Thirty-day mean gradients were similar (7.5 vs 7.6 mm Hg; p = 0.782). In conclusion, patients in the EPROMPT registry receiving the contemporary self-expanding CoreValve Evolut PRO/PRO+ THV demonstrated similar short-term outcomes and hemodynamics across the entire spectrum of LVOT calcium.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Despite advances in transcatheter aortic valve replacement (TAVR) technology, periprocedural stroke remains a complication of TAVR procedures. The TriGUARD 3 device is designed to be positioned in ...the aortic arch to deflect debris away from the brachiocephalic, left common carotid, and left subclavian arteries during TAVR. The United States Food and Drug Administration (FDA) assembled the Circulatory System Devices Panel to review safety and effectiveness data for the TriGUARD 3 device. Because of the coronavirus disease 2019 pandemic, this meeting was held virtually. In this manuscript, we summarize the data presented by both the sponsor and FDA, as well as the panel discussion.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
Adverse events, including cardiac involvement, after vaccination for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been reported. We sought to evaluate trends of hospital ...encounters for vaccine recipients before and after vaccination. We analyzed patients who received the coronavirus disease 2019 (COVID-19) vaccine in the MedStar Health system (11 hospitals in Washington, District of Columbia and Maryland) from December 2020 through August 2021. We then compared hospital encounters (emergency department visits) of patients 60 days before a vaccine dose and 30 days after a vaccine dose, along with encounters related to the SARS-CoV-2 infection itself. The cohort included 5,217 patients who were vaccinated against COVID-19. Our analysis revealed a total of 6,751 emergency department visits, and we divided this total into 3 cohorts: fully vaccinated (n = 1,779), in vaccination window (n = 1,420), and before vaccination (n = 3,552). We found no significant association between vaccination and rate of presentation for acute coronary syndrome, pericarditis, myocarditis, heart failure, conduction abnormality, or noncardiac conditions. Further, encounters for complications related to SARS-CoV-2 infection decreased significantly from those before vaccination (5.4%) to those in vaccination window (4.2%) to those who were fully vaccinated (1.6%). These findings were consistent when all vaccinated encounters were combined into 1 cohort (fully vaccinated + in vaccination window). In conclusion, our analysis suggests that there is no significant association of COVID-19 vaccination with the rate of hospital encounters for cardiac disease, including acute coronary syndrome, pericarditis, myocarditis, congestive heart failure, and conduction abnormality. Further, administration of the vaccine resulted in a significant decrease in hospital encounters for SARS-CoV-2 infections and associated complications.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Studies have reported worse outcomes after transcatheter aortic valve implantation (TAVI) in women receiving early generation transcatheter heart valves (THVs). They have smaller aortic annuli, which ...could result in higher gradients and more patient-prosthesis mismatch (PPM) after TAVI. We investigated the interactions between contemporary THV hemodynamics and outcomes in women who underwent TAVI. We conducted a retrospective, observational study of patients who underwent contemporary TAVI from 2015 to 2020. We compared baseline characteristics, in-hospital outcomes, and hemodynamics according to sex. We then dichotomized women according to aortic annular area (<430 or ≥430 mm2). Included were 869 patients who underwent TAVI with the SAPIEN 3 or CoreValve Evolut PRO/PRO+. Most patients with small annuli were female (82.5%). They had nonsignificantly higher mortality (30-day: 1.5% vs 0.6%, p = 0.313; 1-year: 4.1% vs 2.7%, p = 0.265). Those who received self-expanding THVs had lower gradients (8.0 mm Hg vs 13.8 mm Hg, p <0.001), resulting in less moderate PPM (21.2% vs 73.6%, p <0.001), similar severe PPM (19.5% vs 15.3%, p = 0.454), and higher rates of pacemaker implantation (14.4% vs 4.2%, p = 0.009). Women with small annuli who received a balloon-expandable THV had nonsignificantly higher mortality (30-day: 2.1% vs 0.8%, p = 0.631; 1-year: 6.3% vs 1.7%, p = 0.118). In conclusion, women who underwent contemporary TAVI had nonsignificantly higher mortality, which could be due to higher PPM rates. These findings were more pronounced in the subset of women with small annuli, in whom those who received self-expanding THVs demonstrated superior hemodynamics at the cost of increased rates of pacemaker implantation.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Spontaneous coronary artery dissection (SCAD) is a rare cause of ST-segment elevation myocardial infarction (STEMI), predominantly affecting women. Because primary percutaneous coronary intervention ...(PPCI) is reserved for a select group of patients, vulnerable and minority patients may experience delays in appropriate management and adverse outcomes. We examined the racial differences in the outcomes for patients with SCAD who underwent PPCI for STEMI. Records of patients aged ≥18 years who underwent PPCI for SCAD-related STEMI between 2016 and 2020 were identified from the National Inpatient Sample database. Clinical, socioeconomic, and hospital characteristics were compared between non-White and White patients. Weighted multivariate analysis assessed the association of race with inpatient mortality, length of stay (LOS), and hospitalization costs. The total weighted estimate of patients with SCAD-STEMI who underwent PPCI was 4,945, constituting 25% non-White patients. Non-White patients were younger (56 vs 60.7 years, p <0.001); had a higher prevalence of diabetes, acute renal failure, and obesity; and were more likely to be uninsured and be in the lowest income group. Inpatient mortality (7.7% vs 8.4%, p = 0.74) and hospitalization costs ($34,213 vs $31,858, p = 0.27) were similar for non-White and White patients, and the adjusted analysis did not show any association between the patients’ race and inpatient mortality (odds ratio 0.60, 95% confidence interval CI 0.32 to 1.13, p = 0.11) or hospitalization costs (β β coefficient: 215, 95% CI −4,193 to 4,623, p >0.90). Similarly, there was no association between the patients’ race and LOS (incident rate ratio 1.20, 95% CI 1.00 to 1.45, p = 0.054). The weighted multivariate analysis showed that age; clinical co-morbidities such as diabetes, acute renal failure, valvular dysfunction, and obesity; low-income status; and hospitalization in the western region were associated with adverse outcomes. In conclusion, our study does not show any differences in inpatient mortality, LOS, and hospitalization costs between non-White and White patients who underwent PPCI for SCAD-related STEMI.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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