Angiographic characteristics of patients with STEMI and COVID-19: Insights from NACMI registry.

BACKGROUND: To date, there has been no independent core lab angiographic analysis of patients with COVID-19 and STEMI. The study characterized the angiographic parameters of patients with COVID-19 and STEMI. METHODS: Angiograms of patients with COVID-19 and STEMI from the North American COVID-19 Myocardial Infarction (NACMI) Registry were sent to a Core Laboratory in Vancouver, Canada. Culprit lesion(s), Thrombolysis In Myocardial Infarction (TIMI) flow, Thrombus Grade Burden (TGB), and percutaneous coronary intervention (PCI) outcome were assessed. RESULTS: From 234 patients, 74% had one culprit lesion, 14% had multiple culprits and 12% had no culprit identified. Multivessel thrombotic disease and multivessel CAD were found in 27% and 53% of patients, respectively. Stent thrombosis accounted for 12% of the presentations and occurred in 55% of patients with previous coronary stents. Of the 182 who underwent PCI, 60 (33%) had unsuccessful PCI due to post-PCI TIMI flow <3 (43/60), residual high thrombus burden (41/60) and/or thrombus related complications (27/60). In-hospital mortality for successful, partially successful, and unsuccessful PCI was 14%, 13%, and 27%, respectively. Unsuccessful PCI was associated with increased risk of in-hospital mortality (risk ratio [RR] 1.96; 95% CI: 1.05-3.66, P = .03); in the adjusted model this estimate was attenuated (RR: 1.24; 95% CI: 0.65-2.34, P = .51). CONCLUSION: In patients with COVID-19 and STEMI, thrombus burden was pervasive with notable rates of multivessel thrombotic disease and stent thrombosis. Post-PCI, persistent thrombus and sub-optimal TIMI 3 flow rates led to one-third of the PCI's being unsuccessful, which decreased over time but remained an important predictor of in-hospital mortality.

A novel approach to saline/contrast delivery in excimer laser coronary atherectomy (ELCA) to enhance efficacy: MAXCon ELCA technique.

The advent of excimer laser coronary atherectomy (ELCA) nearly four decades ago heralded a novel way to treat complex lesions, both coronary and peripheral, which were previously untraversable and thus untreatable. These complex lesions include heavily calcified lesions, ostial lesions, bifurcation lesions, chronic total occlusions, in-stent restenosis (including stent underexpansion), and degenerative saphenous vein grafts. We discuss the technology of ELCA, its indications, applications, and complications, and suggest the "MAXCon ELCA" technique for better outcomes without increased risk. Lastly, we present a case of MAXCon ELCA effectively treating a complex lesion.

Coronary microvascular dysfunction assessment: A comparative analysis of procedural aspects.

BACKGROUND: Full adoption of coronary microvascular dysfunction (CMD) assessment faces challenges due to its invasive nature and concerns about prolonged procedure time and increased contrast and/or radiation exposure. We compared procedural aspects of CMD invasive assessment to diagnostic left heart catheterization (DLHC) in patients with chest pain who were not found to have obstructive coronary artery disease. METHODS: A total of 227 patients in the Coronary Microvascular Disease Registry were compared to 1592 patients who underwent DLHC from August 2021 to November 2023. The two cohorts were compared using propensity-score matching; primary outcomes were fluoroscopy time and total contrast use. RESULTS: The participants' mean age was 64.1 ± 12.6 years. CMD-assessed patients were more likely to be female (66.5% vs. 45.2%, p < 0.001) and have hypertension (80.2% vs. 44.5%, p < 0.001), history of stroke (11.9% vs. 6.3%, p = 0.002), and history of myocardial infarction (20.3% vs. 7.7%, p < 0.001). CMD assessment was safe, without any reported adverse outcomes. A propensity-matched analysis showed that patients who underwent CMD assessment had slightly higher median contrast exposure (50 vs. 40 mL, p < 0.001), and slightly longer fluoroscopy time (6.9 vs. 4.7 min, p < 0.001). However, there was no difference in radiation dose (209.3 vs. 219 mGy, p = 0.58) and overall procedure time (31 vs. 29 min, p = 0.37). CONCLUSION: Compared to DLHC, CMD assessment is safe and requires only slightly additional contrast use (10 mL) and slightly longer fluoroscopy time (2 min) without clinical implications. These findings emphasize the favorable safety and feasibility of invasive CMD assessment.

Temporal trends with the Evolut family of self-expanding transcatheter heart valves: A single-center experience.

BACKGROUND: The Evolut self-expanding valve (SEV) systems (Medtronic), were designed to accommodate varying valve sizes and reduce paravalvular leak (PVL) while maintaining a low delivery profile. These systems have evolved between product generations, alongside valve deployment techniques changing over time. AIMS: This study aimed to examine whether these changes impacted clinical outcomes. METHODS: EPROMPT is a prospective, investigator-initiated, postmarketing registry of consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) using the Evolut PRO/PRO+ SEV system. A total of 300 patients were divided into three consecutive cohorts of 100 patients according to implantation date (January to October 2018, November 2018 to July 2020, and August 2020 to November 2021). Procedural and clinical outcomes over these time periods were compared. RESULTS: Valve Academic Research Consortium (VARC)-2 device implantation success improved over time (70.0% vs. 78.0% vs. 88.8%, p = 0.01), with a similar trend for VARC-3 device success (94.7% vs. 81.7% vs. 96.8%, p < 0.001). PVL (all degrees) frequency was likewise reduced over time (31.0% vs. 17.0% vs. 19.2%, p = 0.04). Furthermore, a trend was noticed toward shorter procedure times and shorter length of stay. However, postprocedural pacemaker implantation rates did not significantly differ (15.2% vs. 21.1% vs. 14.0%, p = 0.43). CONCLUSION: During a 3-year period, we demonstrated better TAVR outcomes with newer SEV iterations, alongside changes in implantation techniques, which might result in better procedural and clinical outcomes. However, we did not see a significant change in peri-procedural pacemaker rates for SEV.

Prognostic implication of hemoglobin reduction with and without clinical bleeding after percutaneous coronary intervention in patients with acute coronary syndromes.

BACKGROUND: Bleeding events are associated with higher mortality rates in patients with cardiovascular diseases, including patients presenting with acute coronary syndrome (ACS) undergoing coronary revascularization. We aimed to determine whether a reduction in hemoglobin (Hgb) from pre- to postpercutaneous coronary intervention (PCI), with or without evidence of clinical bleeding, is a correlate of in-hospital mortality for patients presenting with ACS who underwent primary PCI. METHODS: We divided 33816 consecutive patients with ACS who underwent PCI into three categories: (1) target group (defined as Hgb reduction without overt bleeding [n = 112]); (2) Hgb reduction with overt bleeding (n = 48); and (3) control group (defined as no Hgb reduction and no overt bleeding [n = 3156]). Hgb reduction was defined as a drop of >3 g/dL in Hgb value from preprocedure and postprocedure during the index hospitalization. The primary outcome was in-hospital mortality. We used logistic regression to examine the relationship between Hgb reduction with and without bleeding and in-hospital mortality. RESULTS: In crude analysis, the Hgb reduction with overt bleed group had a higher in-hospital mortality rate (16.7%) than the target (9.8%) and control groups (0.6%). Adjusted logistic regression estimates a 0.393 (95% confidence interval [CI]: 0.137, 1.869) odds ratio for in-hospital death of the target group over the Hgb reduction with bleed group, and a 54.517 (95% CI: 2.07, >1000) odds ratio of the target group over the control group. CONCLUSIONS: In patients presenting with ACS undergoing PCI, Hgb reduction with and without overt bleeding were both independently associated with in-hospital mortality.

Overview of the FDA's Circulatory System Devices Panel virtual meeting on the TransMedics Organ Care System (OCS) Heart - portable extracorporeal heart perfusion and monitoring system.

There are a limited number of donor hearts available for transplantation every year, and an even lower number of these hearts actually undergo transplantation. One of the barriers to utilizing donor hearts is the inferior outcomes associated with prolonged ischemic times. There have been increasing attempts to develop alternative techniques for prolonged storage to raise the number of heart transplants while maintaining acceptable outcomes. One such new technology utilizes continuous ex vivo perfusion of the donor heart with oxygenated blood and allows for prolonged storage and preservation times. The TransMedics Organ Care System (OCS) Heart (TransMedics; Andover, MA) claims to optimize the condition of the donor organs by preserving them in a warm, functioning environment. On April 6, 2021, the United States Food and Drug Administration convened a virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to provide guidance on the TransMedics OCS Heart System's application for premarket approval. This application was subsequently approved on September 7, 2021. We provide an overview of the meeting, including the results of the clinical trials that were presented.

Overview of FDA Circulatory System Devices Panel virtual meeting on TriGUARD 3 cerebral embolic protection.

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.

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.

Impact of left ventricular outflow tract calcium on valve geometry in self-expanding transcatheter aortic-valve replacement.

OBJECTIVES: Evaluate transcatheter heart valve (THV) geometry according to left ventricular outflow tract (LVOT) calcium degree and its impact on hemodynamics and outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) with a contemporary self-expanding THV. BACKGROUND: LVOT calcium remains challenging for contemporary THVs. LVOT calcium location and degree may affect THV deployment and impact flow patterns and shear stress, accelerating THV degeneration. METHODS: EPROMPT (CoreValve Evolut Pro Prospective Registry; NCT03423459) is a prospective, investigator-initiated, multicenter registry of patients undergoing TAVR using CoreValve Evolut PRO/PRO + THVs. A total of 107 patients were enrolled in EPROMPT's computed tomography (CT) cohort between January 2018 and October 2021. These patients underwent follow-up CT scan 30 days post-TAVR. We analyzed THV geometry and its interaction with the aortic root following deployment using 30-day post-TAVR CT in patients with none/mild versus moderate/severe LVOT calcium. RESULTS: Thirty-day THV inflows were less eccentric in the short axis in patients with none/mild versus moderate/severe LVOT calcium (1.16 ± 0.09 vs. 1.21 ± 0.12; p = 0.007). THV became more circular and was similar between both cohorts at the THV waist (1.08 ± 0.06 vs. 1.09 ± 0.11; p = 0.551), leaflet tips (1.03 ± 0.04 vs. 1.05 ± 0.09; p = 0.299), and THV outflow (1.04 ± 2.2 vs. 1.03 ± 2.7; p = 0.143). Thirty-day > mild paravalvular leak was low in both cohorts (1.5% vs. 2.4%; p = 0.724); mean gradients were similar (7.7 ± 3.6 vs. 7.7 ± 3.4 mmHg; p = 0.955). CONCLUSIONS: Despite inflow deformities observed in patients with moderate/severe LVOT calcium, Evolut PRO/PRO + conforms to elliptical aortic annuli, maintaining circularity and proper function at the leaflets and outflow, even in patients with moderate/severe LVOT calcium.

Prosthetic valve endocarditis after transcatheter aortic valve replacement in low-risk patients.

OBJECTIVES: We sought to report details of the incidence, organisms, clinical course, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter aortic valve replacement (TAVR) in low-risk patients. BACKGROUND: PVE remains a rare but devastating complication of aortic valve replacement. Data regarding PVE after TAVR in low-risk patients are lacking. METHODS: We performed a detailed review of all patients in the low-risk TAVR trials who underwent TAVR from 2016 to 2020 and were adjudicated to have definitive PVE by the independent Clinical Events Committee. RESULTS: We analyzed 396 low-risk patients who underwent TAVR (including 72 with bicuspid valves). PVE occurred in 11 patients at a median 379 days (210, 528) from TAVR. The incidence within the first 30 days was 0%; days 31-365, 1.5%; and after day 365, 2.8%. The most common organism identified was Streptococcus (n = 4/11). Early PVE (≤ 365 days) occurred in five patients, of whom three demonstrated evidence of embolic stroke and two underwent surgical aortic valve re-intervention. Late PVE (> 365 days) occurred in six patients, of whom thee demonstrated evidence of embolic stroke and only one underwent surgical aortic valve re-intervention. Of the six patients with evidence of embolic stroke, two died, two were discharged to rehabilitation, and two were discharged home with home care. CONCLUSIONS: PVE was infrequent following TAVR in low-risk patients but was associated with substantial morbidity and mortality. Embolic stroke complicated the majority of PVE cases, contributing to worse outcomes in these patients. Efforts must be undertaken to minimize PVE in TAVR.

Exploiting the Transformation Temperature to Reform an Infolded Nitinol Self-Expanding Peripheral Stent.

PURPOSE: Nickel-titanium (nitinol) alloys possess a special set of properties that allow for a wide range of applications. Specifically, the transformation temperature for self-expanding nitinol peripheral stents allows for easy crimping at or below room temperature and reformation at body temperature becoming superelastic. CASE REPORT: We report the case of an elderly man with iliac stenting 1 month prior, who presented several weeks after recovering from coronavirus disease 2019 with recurrent anterior-wall ST-elevation myocardial infarction. This was complicated by deformation and infolding of the previously implanted nitinol self-expanding stent in his right common iliac artery (CIA). Understanding nitinol's specific properties, we proceeded with rapid injections of iced saline to cool the nitinol stent to its transformation temperature while nudging the distal end of the stent with a partially inflated balloon. This maneuver softened the nitinol stent, allowing us to "unfold" and reappose it against the wall of the right CIA, resulting in successful restoration of the original shape of the nitinol self-expanding stent. CONCLUSION: This represents the first reported case describing treatment of an infolded nitinol self-expanding peripheral stent by exploiting the transformation temperature of nitinol using iced cold saline to successfully restore the stent's original shape and structure.

Cangrelor vs. glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention.

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.

National trends and 30-day readmission rates for next-day-discharge transcatheter aortic valve replacement: An analysis from the Nationwide Readmissions Database, 2012-2016.

Transcatheter aortic valve replacement (TAVR) has evolved toward a minimalist approach, resulting in shorter hospital stays. Real-world trends of next-day discharge (NDD) TAVR are unknown. This study aimed to evaluate underlying trends and readmissions of NDD TAVR. METHODS: This study was derived from the Nationwide Readmissions Database from 2012 to 2016. International Classification of Diseases, Ninth and Tenth Revisions, codes were used to identify patients. Any discharge within 1 day of admission was identified as NDD. NDD TAVR trends over the years were analyzed, and any admissions within 30 days were considered readmissions. A hierarchical logistic regression model was used to identify predictors of readmission. RESULTS: Of 49,742 TAVR procedures, 3,104 were NDD. The percentage of NDD TAVR increased from 1.5% (46/3,051) in 2012 to 12.2% (2,393/19,613) in 2016. However, the 30-day readmission rate remained the same over the years (8.6%). The patients' mean age was 80.3 ±â€¯8.4 years. Major readmission causes were heart-failure exacerbation (16%), infections (9%), and procedural complications (8%). In 2016, there were significantly higher late conduction disorder and gastrointestinal bleeding readmission rates than in 2012-2015. Significant predictors of readmission were anemia, baseline conduction disease, cardiac arrhythmias, heart failure, chronic kidney disease, chronic obstructive pulmonary disease, neoplastic disorders, and discharge to facility. CONCLUSIONS: The percentage of NDD TAVR increased over the years; however, readmission rates remained the same, with a higher rate of conduction abnormality-related hospitalizations in 2016. Careful discharge planning that includes identification of baseline factors that predict readmission and knowledge of etiologies may further prevent 30-day readmissions.

Propensity-matched comparison of large-bore access closure in transcatheter aortic valve replacement using MANTA versus Perclose: A real-world experience.

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.

Micropuncture technique for femoral access is associated with lower vascular complications compared to standard needle.

OBJECTIVES: We compared access-site complications with a Micropuncture 21-gauge (G) needle to a standard 18G needle in patients undergoing femoral-access percutaneous coronary intervention (PCI). BACKGROUND: Vascular access-site complications are the most common complication after cardiac catheterization. These complications increase patient morbidity and mortality, along with healthcare costs. METHODS: We retrospectively analyzed a cohort of 17,844 consecutive patients undergoing PCI. Micropuncture access was used in 2344 patients and a standard 18G needle in 15,500 patients. Primary endpoints included vascular perforation or limb ischemia requiring repair, retroperitoneal bleeding, pseudoaneurysm, arteriovenous fistula, groin hematoma (>4 cm). RESULTS: Patients undergoing PCI with Micropuncture were at higher risk: they were on anticoagulation (557 [23.7%] vs. 1,590 [10.2%], p < .001), used steroids more frequently (131 [5.6%] vs. 638 [4.1%], p < .001) and required the use of an intra-aortic balloon pump more often (191 [(8.1%] vs. 896 [5.7%], p < .001). Overall, the access-site complications rate was lower using Micropuncture (58 [2.5%]) versus standard needle (558 [3.6%], p = .005). The Micropuncture group had a significantly lower rate of hematoma than standard needle (32 [1.4%] vs. 309 [1.9%], p = .03). There was no significant difference in the rate of limb ischemia (1 [0.04%] vs. 12 [0.07%], p = .56), perforation (2 [0.08%] vs. 14 [0.09%], p = .93), retroperitoneal bleeding (3 [0.12%] vs. 18 [0.11%], p = .87), pseudoaneurysm (18 [0.76%] vs. 170 [1.09%], p = .14), and arteriovenous fistula (2 [0.08%] vs. 35 [0.22%], p = .16), comparing the Micropuncture group to a standard needle, respectively. CONCLUSIONS: Femoral access using a Micropuncture reduced the rate of vascular complications with significant reduction in the rate of groin hematomas.

Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience.

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.

Pericardiocentesis induced right ventricular changes in patients with and without pulmonary hypertension.

BACKGROUND: Pericardial effusion drainage in patients with significant pulmonary hypertension (PH) has been questioned because of hemodynamic collapse concern, mainly because of right ventricular (RV) function challenging assessment. We aimed to assess RV function changes related to pericardiocentesis in patients with and without PH. METHODS: Consecutive patients with symptomatic moderate-to-large pericardial effusion who had either echocardiographic or clinical signs of cardiac tamponade and who underwent pericardiocentesis from 2013 to 2018 were included. RV speckle-tracking echocardiography analysis was performed before and after pericardiocentesis. Patients were stratified by significant PH (pulmonary artery systolic pressure [PASP] ≥50 mm Hg). RESULTS: The study cohort consisted of 76 patients, 23 (30%) with PH. In patients with PH, both end-diastolic and end-systolic areas (EDA, ESA) increased significantly after pericardiocentesis (22.6 ± 8.0 cm2 -26.4 ± 8.4 cm2 , P = .01) and (15.9 ± 6.3 cm2 -18.7 ± 6.5 cm2 , P = .02), respectively. However, RV function indices including fractional area change (FAC: 30.6 ± 13.7%-29.1 ± 8.8%, P = .61) and free-wall longitudinal strain (FWLS: -16.7 ± 6.7 to -15.9 ± 5.0, P = .50) remained unchanged postpericardiocentesis. In contrast, in the non-PH group, after pericardiocentesis, EDA increased significantly (20.4 ± 6.2-22.4 ± 5.9 cm2 , P = .006) but ESA did not (14.9 ± 5.7 vs 15.0 ± 4.6 cm2 , P = .89), and RV function indices improved (FAC 27.9 ± 11.7%-33.1 ± 8.5%, P = .003; FWLS -13.6 ± 5.4 to -17.2 ± 3.9%, P < .001). CONCLUSION: Quantification of RV size and function can improve understanding of echocardiographic and hemodynamic changes postpericardiocentesis, which has the potential to guide management of PH patients with large pericardial effusion.

Comparison of coronary revascularization appropriateness for non-acute coronary syndrome cases under the 2017 update vs the 2012 appropriate use criteria.

OBJECTIVES: To compare coronary revascularization appropriateness for non-acute coronary syndrome cases under the 2017 update vs the 2012 appropriate use criteria (AUC). BACKGROUND: In 2017, the 2012 AUC for coronary revascularization were updated. We examined how applying these new 2017 updates to our previous inappropriate cases would change their appropriateness. METHODS: We identified 50 cases of patients who underwent coronary revascularization for stable ischemic heart disease who were deemed inappropriate under the 2012 AUC. Two separate physicians reviewed the cases and applied a new AUC based on the 2017 AUC. Next, if there was a change, the reason was identified. RESULTS: Average age was 64, majority being male (29; 58%). Forty-two (84%) were asymptomatic upon presentation. Most cases (27, 54%) dealt with percutaneous coronary intervention (PCI) of the right coronary artery. After applying the 2017 AUC, 34 of the 50 inappropriate failures (68%) would be changed from "inappropriate" to "may be appropriate care." Of the 34 cases, 25 (73.5%) were changed due to the new AUC no longer expecting the patient to be on ≥2 anti-angina medications prior to PCI. Of the 34 cases, eight (23.5%) were changed due to the new AUC expanding the use of non-invasive modalities. CONCLUSIONS: Applying the 2017 AUC led to a statistically higher number of cases being deemed "may be appropriate." The most common cause for the change included the change in requirement for anti-angina regimen and the expanded role of non-invasive modalities.