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Graphical AbstractTransradial vs. transfemoral approach for PCI in STEMI complicated by cardiogenic shock.

Recent efforts to improve patient safety have included the creation of the Agency for Healthcare Research and Quality that has funded a number of projects aimed at enhancing patient safety. [...]

Mechanical complications after transcatheter aortic valve replacement are fortunately rare with the current generation of devices. Unfortunately, life-threatening complications will occur and it is the responsibility of operators to be familiar with strategies to prevent and manage these challenging scenarios. Because these cases will not occur often, it is important for us to highlight and talk about those that do occur, to learn best practices in how to manage and prevent them going forward. We can learn much from each other’s good crash landings.

With the increasing frequency of catheter-based interventions in congenital heart disease and structural heart disease, the use of fusion imaging has become a major enhancement for understanding complex anatomy and facilitating key steps in interventional procedures. Because transesophageal echocardiography and fluoroscopy are displayed in different visual perspectives, the interventional cardiologist must mentally reregister the images from the two modalities during the procedure. Echocardiography-fluoroscopy fusion (EFF) imaging displays the x-ray and ultrasound overlay images in the same visual perspective. This new technology allows for enhanced team communication, improved visual guidance, and more efficient navigation. The purpose of this review is to describe the EFF imaging technology, current uses of EFF imaging in congenital and structural heart disease, and future directions that will enhance this unique imaging technology to guide interventional procedures.

IMPORTANCE: Physicians have been criticized for having an overly enthusiastic response to new device approvals, especially for novel technologies. However, to our knowledge, the rates of new product adoption and patterns of new device usage in clinical practice have not been well described. OBJECTIVE: To characterize the patterns of uptake of bioresorbable vascular scaffolds (BVS) within the United States following device approval and to describe changes in response to subsequent releases of data and US Food and Drug Administration (FDA) warnings. DESIGN, SETTING, AND PARTICIPANTS: This analysis of the uptake of BVS between January 2016 and June 2017 used CathPCI Registry data; all percutaneous coronary intervention (PCI) procedures with an implant of either a BVS or conventional stent were included. Data analysis was performed in October 2017. EXPOSURES: Implant of BVS. MAIN OUTCOMES AND MEASURES: The primary outcome was monthly use of BVS in the United States. In addition, the characteristics of patients who received BVS and of hospitals that used BVS were assessed and comparisons of patient characteristics between BVS recipients and patients who were treated contemporaneously with metallic stents were made. RESULTS: Of 682 951 procedures, 471 064 (69.0%) were done in men, 587 301 (86.0%) were among white people, and the mean (SD) age of those undergoing procedures with BVS vs conventional stents was 62.6 (11.4) years vs 65.7 (11.9) years. Of these, 4265 procedures (0.6%) used BVS overall (after FDA approval of BVS). Procedures with implants of BVS occurred among patients with fewer comorbidities and lower-acuity presentations compared with procedures with implants of conventional stents. The patient characteristics for BVS use were not dissimilar to the inclusion criteria of the ABSORB III FDA approval trial, with notable differences based on trial eligibility (eg, excluding patients with myocardial infarctions). The maximum monthly use of BVS was 1.25% of all PCI procedures that occurred 90 days after FDA approval, but with site-to-site variability. Declines in use were observed coincident with the scientific presentation of adverse event data as well as FDA warnings. CONCLUSIONS AND RELEVANCE: Most US physicians and hospitals were selective in their use of BVS, primarily using them in patients similar to those in the device’s FDA approval trial. In addition, declines in use were evident in the subsequent month following the release of data that reported negative outcomes. These results illustrate an example of an appropriate physician response to adverse data updates and FDA warnings.

IMPORTANCE: Recent data support percutaneous revascularization as an alternative to coronary artery bypass grafting in unprotected left main (ULM) coronary lesions. However, the relevance of these trials to current practice is unclear, as patterns and outcomes of ULM percutaneous coronary intervention (PCI) in contemporary US clinical practice are not well studied. OBJECTIVE: To define the current practice of ULM PCI and its outcomes and compare these with findings reported in clinical trials. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional multicenter analysis included data collected from 1662 institutions participating in the National Cardiovascular Data Registry (NCDR) CathPCI Registry between April 2009 and July 2016. Data were collected from 33 128 patients undergoing ULM PCI and 3 309 034 patients undergoing all other PCI. Data were analyzed from June 2017 to May 2018. MAIN OUTCOMES AND MEASURES: Patient and procedural characteristics and their temporal trends were compared between ULM PCI and all other PCI. In-hospital major adverse clinical events (ie, death, myocardial infarction, stroke, and emergent coronary artery bypass grafting) were compared using hierarchical logistic regression. Characteristics and outcomes were also compared against clinical trial cohorts. RESULTS: Of the 3 342 162 included patients, 2 223 570 (66.5%) were male, and the mean (SD) age was 64.2 (12.1) years. Unprotected left main PCI represented 1.0% (33 128 of 3 342 162) of all procedures, modestly increasing from 0.7% to 1.3% over time. The mean (SD) annualized ULM PCI volume was 0.5 (1.5) procedures for operators and 3.2 (6.1) procedures for facilities, with only 1808 of 10 971 operators (16.5%) and 892 of 1662 facilities (53.7%) performing an average of 1 or more ULM PCI annually. After adjustment, major adverse clinical events occurred more frequently with ULM PCI compared with all other PCI (odds ratio, 1.46; 95% CI, 1.39-1.53). Compared with clinical trial populations, patients in the CathPCI Registry were older with more comorbid conditions, and adverse events were more frequent. CONCLUSIONS AND RELEVANCE: Use of ULM PCI has increased over time, but overall use remains low. These findings suggest that ULM PCI occurs infrequently in the United States and in an older and more comorbid population than that seen in clinical trials.

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Aims: While randomized clinical trials have compared clopidogrel with higher potency adenosine diphosphate (ADP) receptor inhibitors among patients with acute myocardial infarction, little is known about the frequency, effectiveness and safety of switching between ADP receptor inhibitors in routine clinical practice.Methods and results: We studied 11,999 myocardial infarction patients treated with percutaneous coronary intervention at 230 hospitals from April 2010 to October 2012 in the TRANSLATE-ACS study. Multivariable Cox regression was used to compare six-month post-discharge risks of major adverse cardiovascular events (MACE: death, myocardial infarction, stroke, or unplanned revascularization) and Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO)-defined bleeding between in-hospital ADP receptor inhibitor switching versus continuation of the initially selected therapy. Among 8715 patients treated initially with clopidogrel, 994 (11.4%) were switched to prasugrel or ticagrelor; switching occurred primarily after percutaneous coronary intervention (60.9%) and at the time of hospital discharge (26.7%). Among 3284 patients treated initially with prasugrel or ticagrelor, 448 (13.6%) were switched to clopidogrel; 48.2% of switches occurred after percutaneous coronary intervention and 48.0% at hospital discharge. Switching to prasugrel or ticagrelor was not associated with increased bleeding when compared with continuation on clopidogrel (2.7% vs. 3.3%, adjusted hazard ratio 0.96, 95% confidence interval 0.64–1.42, p=0.82). Switching from prasugrel or ticagrelor to clopidogrel was not associated with increased MACE (8.9% vs. 7.7%, adjusted hazard ratio 1.06, 95% confidence interval 0.75–1.49, p=0.76) when compared with continuation on the higher potency agent.Conclusions: In-hospital ADP receptor inhibitor switching occurs in more than one in 10 myocardial infarction patients in contemporary practice. In this observational study, ADP receptor inhibitor switching does not appear to be significantly associated with increased hazard of MACE or bleeding.

Recent reductions in average door-to-balloon (D2B) times have not been associated with decreases in mortality at the population level. We investigated this seemingly paradoxical finding by assessing components of this association at the individual and population levels simultaneously. We postulated that the changing population of patients undergoing primary percutaneous coronary intervention (pPCI) contributed to secular trends toward an increasing mortality risk, despite consistently decreased mortality in individual patients with shorter D2B times.

Whether increasing use of radial access has improved percutaneous coronary intervention outcomes remains unknown. We sought to determine the relationship between increasing facility-level use of transradial percutaneous coronary intervention (TRI) and periprocedural outcomes.

Conflicting evidence exists on sex-based outcomes after coronary stenting.

The Department of Veterans Affairs Randomized OnOff Bypass (ROOBY) trial compared clinical and angiographic outcomes in off-pump versus on-pump coronary artery bypass graft (CABG) surgery to ascertain the relative efficacy of the 2 techniques.

The National Cardiovascular Data Registry CathPCI Registry was recently linked with longitudinal Centers for Medicare & Medicaid (CMS) claims data. The degree to which this linked cohort is representative of the overall CathPCI Registry and CMS PCI populations is unknown.

Although fixed view x-ray angiography remains the primary technique for anatomic imaging of coronary artery disease, the known shortcomings of 2D projection imaging may limit accurate 3D vessel and lesion definition and characterization. A recently developed method to create 3D images of the coronary arteries uses x-ray projection images acquired during a 180° C-arm rotation and continuous contrast injection followed by ECG-gated iterative reconstruction. This method shows promise for providing high-quality 3D reconstructions of the coronary arteries with no user interaction but requires clinical evaluation.

Focuses on the islanders of Inis Beag, in Ireland, and their rich tradition of local humor. How the islanders survive; Life styles and customs; Practical jokes; Direction of ridicule against the Irish government; Anticlericalism; How tourists are often the targets of humor; Nicknames and humor; Oral art traditions; Proverbs and word play; Ballads.

Ethacrynic acid [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxyl] acetic acid, is a water-soluble diuretic agent that has been shown to potentiate the in vitro cytotoxicity of chemotherapeutic agents in established cell lines. We used the differential staining cytotoxicity (DiSC) assay to determine whether ethacrynic acid at 1 and 3.3 µMwould potentiate the cytotoxicity of nitrogen mustard and/or doxorubicin in primary cultures of hematologic neoplasms from heavily pretreated patients and in normal peripheral blood lymphocytes. At 3.3 µM, ethacrynic acid was toxic to 8 of 24 (33%) tumor specimens studied. In subsequent studies, ethacrynic acid at 1 µMwas toxic to only 2 of 54 (4%) tumor specimens. Significant enhancement for doxorubicin or nitrogen mustard was confined to lymphatic malignancies and to normal peripheral blood lymphocytes. Interspecimen variability was observed, with no enhancement in most individual specimens, 2-fold enhancement in some specimens, and 4-fold enhancement in occasional specimens. Clinical trials will be required to determine whether the observed in vitro activity for ethacrynic acid is associated with clinical benefit in unselected or assay-selected patients.

A 19-year-old white man with familial hypokalemic periodic paralysis developed evidence of cardiac dysfunction during a episode of flaccid paralysis. This consisted of elevated total creatinine phosphokinase (CPK), an increased myocardial fraction of CPK (myocardial band), alteration in the lactic dehydrogenase isoenzyme pattern, severe bradycardia, and evidence of left ventricular dysfunction. These findings, in conjunction with selected cases from the literature, suggest the possibility that cardiomyopathy may be a heretofore unrecognized complication of this disorder.

This paper examines the major causes underlying the spread of what African elders and Westerners alike regard as immoral behavior among Anang youth in Southeastern Nigeria. The Anang have experienced profound cultural change since World War I, at which time they were finally pacified by the British and the first trading post and Christian mission were established among them. When this change is assessed, it is apparent that most of the forces contributing to immorality among young people in other African societies are also operative in Anang society, namely the breakdown of traditional political, religious, and kinship forms and the adoption of Western values, especially those in the economic realm.1This paper treats these common causal factors, but emphasizes one in particular which is important in producing immorality among Anang youth: Their acceptance of the Christian concept of forgiveness. Probably this new doctrine is affecting the behavior of other African peoples in a similar manner, but, if so, it has not received adequate attention in acculturation studies.

Carving, raffia weaving, and appliqueing are the main art forms of the northern Anang of Calabar Province, Nigeria. A great variety of carved and woven objects is produced by numerous Anang artisans, many of whom exhibit a high order of talent, especially when creating artifacts for traditional (rather than tourist) usage. Unfortunately, the appliqueing of funeral cloths for ritualistic purposes is a rapidly disappearing art, while the painting of funeral murals to serve the same end, which preceded and for a time was practiced concurrently with appliqueing, has disappeared altogether.Both-carvers and weavers serve the nineteen Anang voluntary associations, of which seven are religious groups, five are social, five are orchestral, and two are dramatic. Four of the associations employ wooden masks, four raffia masks and costumes, and two wooden puppets, and all utilize an assortment of minor carved and woven articles produced by professional artisans. This paper will be concerned with the use of wooden masks, puppets, and figurines by one of the drama associations——in plays which are presented to amuse audiences by ridiculing the motives and actions of well-known individuals and groups. All of the Anang associations have social control functions as regards their membership or the larger community, or both, but , through its system of rules governing the behavior of members and through its plays acted by humans and puppets, exerts the broadest measure of social control of any association-over individuals, kinship and political groups, other associations, and even the missions and, at one time, the colonial government.

IMPORTANCE: Mechanical circulatory support (MCS) devices, including intravascular microaxial left ventricular assist devices (LVADs) and intra-aortic balloon pumps (IABPs), are used in patients who undergo percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) complicated by cardiogenic shock despite limited evidence of their clinical benefit. OBJECTIVE: To examine trends in the use of MCS devices among patients who underwent PCI for AMI with cardiogenic shock, hospital-level use variation, and factors associated with use. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used the CathPCI and Chest Pain-MI Registries of the American College of Cardiology National Cardiovascular Data Registry. Patients who underwent PCI for AMI complicated by cardiogenic shock between October 1, 2015, and December 31, 2017, were identified from both registries. Data were analyzed from October 2018 to August 2020. EXPOSURES: Therapies to provide hemodynamic support were categorized as intravascular microaxial LVAD, IABP, TandemHeart, extracorporeal membrane oxygenation, LVAD, other devices, combined IABP and intravascular microaxial LVAD, combined IABP and other device (defined as TandemHeart, extracorporeal membrane oxygenation, LVAD, or another MCS device), or medical therapy only. MAIN OUTCOMES AND MEASURES: Use of MCS devices overall and specific MCS devices, including intravascular microaxial LVAD, at both patient and hospital levels and variables associated with use. RESULTS: Among the 28?304 patients included in the study, the mean (SD) age was 65.4 (12.6) years and 18 968 were men (67.0%). The overall MCS device use was constant from the fourth quarter of 2015 to the fourth quarter of 2017, although use of intravascular microaxial LVADs significantly increased (from 4.1% to 9.8%; P?<?.001), whereas use of IABPs significantly decreased (from 34.8% to 30.0%; P?<?.001). A significant hospital-level variation in MCS device use was found. The median (interquartile range [IQR]) proportion of patients who received MCS devices was 42% (30%-54%), and the median proportion of patients who received intravascular microaxial LVADs was 1% (0%-10%). In multivariable analyses, cardiac arrest at first medical contact or during hospitalization (odds ratio [OR], 1.82; 95% CI, 1.58-2.09) and severe left main and/or proximal left anterior descending coronary artery stenosis (OR, 1.36; 95% CI, 1.20-1.54) were patient characteristics that were associated with higher odds of receiving intravascular microaxial LVADs only compared with IABPs only. CONCLUSIONS AND RELEVANCE: This study found that, among patients who underwent PCI for AMI complicated by cardiogenic shock, overall use of MCS devices was constant, and a 2.5-fold increase in intravascular microaxial LVAD use was found along with a corresponding decrease in IABP use and a significant hospital-level variation in MCS device use. These trends were observed despite limited clinical trial evidence of improved outcomes associated with device use.

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Introduction:Thoracic endovascular aortic repair (TEVAR) and transcatheter aortic valve replacement (TAVR) necessitate large-bore arterial access for stent/valve delivery. With improvement of device delivery technology, percutaneous access has become the standard. This may be associated with fewer complications, though literature is conflicting. The purpose of this study was to compare outcomes of open vs. percutaneous large bore arterial access at a single institution.Hypothesis:Percutaneous arterial access for device delivery is associated with fewer complications than surgical cutdown.Methods:Included were 746 patients who underwent TEVAR or TAVR between over 13 years. Only groins accessed for delivery sheath were included for analysis, with size ranging from 12-28 French (Fr.). Complications assessed included bleeding (hematoma, perforation, rupture, pseudoaneurysm), infection, seroma, dissection, and embolization.Results:Patient characteristics are summarized in Table 1. Sheath diameter was predictive of conversion to open with a median of 20Fr. (IQR 16-22) vs. 16 Fr. (IQR 14-20) in cases that were completed percutaneously (p<=0.004). There was a significantly higher rate of total complications (24.6% vs. 9.4%; p=0.001), infection, and bleeding in open compared to percutaneous cases. No significant differences were observed in seroma, dissection, and embolization.Total complications and infection remained significant after propensity matching. Delivery sites were successfully closed using a median of 2 percutaneous closure devices.Conclusions:Percutaneous access is associated with significantly lower rates of total complications, infection, and bleeding compared to surgical cutdown. Delivery sheath size was predictive of conversion to open, but the overall incidence was low. Large-bore arterial access closure can be safely achieved using a percutaneous strategy, with fewer complications than the open approach.

Pacemaker migration can interfere with correct pacing system function and patient comfort. A Dacron pouch has been developed which may prevent these problems. To assess the efficacy of the pouch, we measured various factors of pacemaker mobility in 100 patients after long-term follow-up. The patients were divided into three groups on the basis of their dictated operative reports: group 1, no pouch or anchoring stitch; group 2, pouch only; group 3, anchoring stitch to pacemaker header or pouch. The average age of the study population was 74.3 ± 11 years. Total follow-up time was 42 ± 28 months (group 1, 53 ± 32 months; group 2, 36 ± 23 months; group 3, 34 ± 25 months). There were no significant differences when pacemakers were measured for movement in the inferosuperior and lateromedial directions, nor was there any difference in the distance between the incision scar and the pacemaker header in any group. There was a significant difference between group 1 and groups 2 and 3 when the degree of tilt of the pacemaker off the chest wall was compared. This was 46° ± 34° for group 1 and 27° ± 26° and 26° ± 27° for groups 2 and 3, respectively (p<0.02 for both). These data suggest that the Dacron pouch does not restrict pacemaker mobility parallel to the chest wall during long-term follow-up but does reduce the angle to which the pacemaker can be tilted relative to the chest wall. (Chest 1991; 99:660–62)

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Information is limited on contemporary use and outcomes of embolic protection devices (EPDs) in saphenous vein graft interventions.

Background:Although radial artery access reduces access site bleeding, increasing use of transradial PCI (TRI) may compromise facility-level outcomes due to patient selection, procedural learning curve, and unintended consequences on femoral PCI management. We sought to determine the relationship between increasing facility-level use of TRI and change in rates of access site bleeding.