Suture closure AFtEr large bore vein access (SAFE-VEIN): A randomized, prospective study of the efficacy and safety of venous closure device.

BACKGROUND: Perclose ProGlide (PPG) Suture-Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. AIMS: We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous access (LBVA) (≥13 French). METHODS: In this physician-initiated, randomized, single-center study [clinicaltrials.gov ID: NCT04632641], single-stick venous access was obtained under ultrasound guidance. Eligible patients were randomized 1:1, and 100 subjects received allocated treatment to either PPG (n = 47) or figure of 8 suture (n = 53). No femoral arterial access was used in any patient. Primary outcomes were time to achieve hemostasis (TTH) and time to ambulation (TTA). Secondary outcomes were time to discharge (TTD) and vascular-related complications and mortality. Wilcoxon rank-sum test was used to compare TTH, TTA, and TTD. RESULTS: TTH (minutes) was significantly lower in PPG versus figure of 8 suture [median, (Q1, Q3)] [7 (2,10) vs. 11 (10,15) respectively, p < 0.001]. TTA (minutes) was significantly lower in PPG compared to figure of 8 suture [322 (246,452) vs. 403 (353, 633) respectively, p = 0.005]. TTD (minutes) was not significantly different between the PPG and figure of 8 suture arms [1257 (1081, 1544) vs. 1338 (1171,1435), p = 0.650]. There was no difference in minor bleeding or access site hematomas between both arms. No other vascular complications or mortality were reported. CONCLUSION: PPG use had lower TTH and TTA than figure of 8 suture in a population of patients receiving LBVA procedures. This may encourage same-day discharge in these patients.

Intentional Oversizing of Valve in Transcatheter Aortic Valve Replacement: Is Bigger Better? A Large, Single-Center Experience.

Background: The current clinical practice standard is 10% to 20% oversizing of self-expanding valves in transcatheter aortic valve replacement. We aimed to determine whether >20% oversizing of self-expanding valves (Medtronic Evolut) would lead to better valve performance with similar or better outcomes. Methods: From October 2011 to December 2016, we approached all transcatheter aortic valve replacement patients with a conscious attempt at large oversizing (>20%). The most common valve used, excluding those used in valve-in-valve patients, was the 29-mm Evolut R (29%). We used a retrospective chart review to compare moderate oversizing (group 1; 10% to 20%) with large oversizing (group 2; >20%). Results: Of 556 patients, 45% were male; the overall mean Society of Thoracic Surgeons risk score was 5.8 ± 3.8. Eighty-five (15%) patients needed a pacemaker, and 21 (3.8%) developed significant paravalvular leak. Mean oversizing was 20.3% ± 6.0%, with 41.4% of patients included in group 1 and 54.5% in group 2. Incidences of complications in group 2 vs. group 1 were as follows: a) paravalvular leak (2.0 vs. 6.1%; odds ratio = 0.31, p = 0.01), b) pacemaker (15 vs. 14%), c) gastrointestinal bleed (n = 4 vs. 0; 1.3 vs. 0.0%; p = 0.03), d) annular dissection (n = 1 vs. 0; 0.3 vs. 0%; p = 0.29), e) mortality (n = 5 vs. 4; 1.6 vs. 1.7%). Incidence of paravalvular leak was higher in those who died than survivors (13 vs. 1.3%; p ≤ 0.0001). Conclusions: These data suggest that, in current self-expanding valves, >20% oversizing delivers a significantly lower prevalence of paravalvular leak without an increase in other complications. Since paravalvular leak is associated with increased mortality, >20% oversizing may represent a superior prosthesis choice.

Use and performance of the evolut FX transcatheter aortic valve system.

BACKGROUND: The next generation supra-annular, self-expanding Evolut FX transcatheter aortic valve (TAV) system was designed to improve catheter deliverability, provide stable and symmetric valve deployment, and assess commissural alignment during the procedure. The impact of these modifications has not been clinically evaluated. METHODS: Procedural information was collected by survey in 2 Stages: Stage I comprised 23 centers with extensive experience with Evolut TAV systems, and Stage II comprised an additional 46 centers with a broad range of balloon- and self-expanding system experience. Operators were to compare the experience with the Evolut FX to the predicate Evolut PRO+ system. RESULTS: There were 285 cases during Stage I from June 24 to August 12, 2022, and 254 cases during Stage II from August 15 to September 11, 2022. Overall, the cusp overlap technique was used in 88.6 %, and commissural alignment was achieved in 96.1 % of these cases. Compared to implanter's previous experience with the Evolut PRO+ system, less resistance was noted with the Evolut FX system: in 83.0 % of cases during vascular insertion, in 84.7 % of cases while tracking through the vasculature, in 84.4 % of cases while traversing over the arch, and 76.1 % of cases in advancing across the valve. Better symmetry of valve depth was observed in 423 of 525 cases (80.6 %). CONCLUSION: Evolut FX system design modifications translated into improvements in catheter deliverability, deployment symmetry and stability, and commissural alignment as assessed by experienced self-expanding and balloon expandable operators.

Biventricular Arrhythmogenic Cardiomyopathy Mimicking Cardiac Sarcoidosis.

Noninvasive imaging is crucial for diagnosing and managing arrhythmogenic cardiomyopathy. Despite advanced multimodality imaging tools, challenges persist in differentiating it from other arrhythmogenic diseases (eg, cardiac sarcoidosis). We present a case of arrhythmogenic cardiomyopathy with an FLNC variant of uncertain significance exhibiting a phenocopy of cardiac sarcoidosis.

Age-Based Trends in the Outcomes of Percutaneous Left Atrial Appendage Occlusion: Insights from a Real-World Database.

The age-based trends in-hospital outcomes in patients with percutaneous left atrial appendage occlusion (LAAO) are unknown. Using the National Readmission Database from 2016 to 2019, patients who underwent LAAO were divided into 2 age groups: 60 to 79 and ≥80 years. The primary objective was to evaluate the age-based trends in the outcomes related to LAAO. The secondary objectives were to evaluate the mean cost and total cumulative cost of readmissions in both age groups in 2019. We identified 58,818 patients who underwent LAAO, of whom 36,964 (63%) were aged 60 to 79 years, and 21,854 (37%) were ≥80 years. The hospital mortality, pericardial complications, acute kidney injury, and in-hospital cardiac arrest did not change over time. The risk-adjusted postoperative stroke and bleeding requiring blood transfusion decreased in patients aged ≥80 years (p trend 0.03 for both outcomes). The length of stay decreased, and early discharge rates increased over time in both the unadjusted and risk-adjusted models in both age groups. The risk-adjusted 90-day readmission rates also decreased in patients aged ≥80 years. The inflation-adjusted cost did not change over time on the unadjusted and adjusted analyses. The total cumulative all-cause 90-readmission cost for both groups in 2019 was $31.7 million. Most outcomes after LAAO either improved or did not change from 2016 to 2019. Hospital mortality has remained <0.5% consistently since 2016. The risk-adjusted postoperative stroke, bleeding, and 90-day readmission rates improved in elderly vulnerable patients aged ≥80 years. The inflation-adjusted cost did not improve despite the decreasing length of stay and improving early discharge rates.

Racial Disparities in Diagnostic Evaluation and Revascularization in Patients With Acute Myocardial Infarction-A 15-Year Longitudinal Study.

We aimed to evaluate longitudinal trends of racial and ethnic disparities in the utilization of diagnostic angiograms, percutaneous coronary intervention (PCI), and coronary artery bypass graft surgery (CABG) for non-ST elevation myocardial infarction (NSTEMI) and ST elevation myocardial infarction (STEMI). We retrospectively analyzed the National Inpatient Sample (2005-2019). The 15-year period was divided into 5, 3-year periods. Our study included 9 million adult patients (NSTEMI, 72%; STEMI, 28%). No improvement in utilization of these procedures was seen in period 5 (2017-2019) vs period 1 (2005-2007) for both NSTEMI and STEMI in non-White patients vs White patients (P > 0.05 for all comparisons), excepting in CABG for STEMI in Black patients vs White patients (difference in CABG rate: period 1, 2.6%; period 5, 1.4%; P = 0.03). Reducing disparities in PCI for NSTEMI and both PCI and CABG for STEMI in Black patients vs White patients was associated with improved outcomes.

Chewed Versus Swallowed Ticagrelor in P2Y12 Inhibitor-Naïve Patients Undergoing Percutaneous Coronary Intervention.

Purpose: Dual antiplatelet therapy is standard for patients undergoing percutaneous coronary intervention (PCI) with stents. Traditionally, patients swallow the loading dose of a P2Y12 inhibitor before or during PCI. Time to achieve adequate platelet inhibition after swallowing the loading dose varies significantly. Chewed tablets may allow more rapid inhibition of platelet aggregation. However, data for this strategy in patients with stable ischemic heart disease or non-ST-elevation acute coronary syndrome (NSTE-ACS) are less robust. Methods: In this single-center prospective trial, 112 P2Y12-naïve patients with stable ischemic heart disease or NSTE-ACS on aspirin therapy and who received ticagrelor after coronary angiography but before PCI were randomized to chewing (n=55) or swallowing (n=57) the ticagrelor loading dose (180 mg). Baseline variables were compared using 2-sample t-test and chi-squared/Fisher's exact tests as appropriate, with alpha set at 0.05. P2Y12 reaction units (PRU) were compared at baseline, 1 hour, and 4 hours using Wilcoxon rank-sum test. Patients then received standard ticagrelor dosing. Results: After exclusions, P2Y12 PRU in the chewed and swallowed groups at baseline, 1 hour, and 4 hours after ticagrelor loading dose were 243 vs 256 (P=0.75), 143 vs 210 (P=0.09), and 28 vs 25 (P=0.89), respectively. No differences were found in major adverse cardiac events (MACE) or major bleeding at 30 days and 1 year. Conclusions: In patients with stable ischemic heart disease or NSTE-ACS, chewing rather than swallowing ticagrelor may lead to slightly faster inhibition of platelet aggregation at 1 hour with no increase in MACE or major bleeding.

Sex Disparities in Diagnostic Evaluation and Revascularization in Patients With Acute Myocardial Infarction-A 15-Year Nationwide Study.

Background Although sex disparities in the diagnostic evaluation and revascularization of patients with acute myocardial infarction are well documented, no study has evaluated longitudinal trends in these disparities. Methods and Results Using the National Inpatient Sample from 2005 to 2019, 9 259 932 patients with acute myocardial infarction were identified. We divided 15 years into five 3-year periods. The primary objective was to evaluate sex-based trends in the use of diagnostic angiography, percutaneous coronary intervention, and coronary artery bypass graft (CABG) among patients with non-ST-segment-elevation myocardial infarction and ST-segment-elevation myocardial infarction (STEMI) over 15 years. The secondary objective was to evaluate sex disparities in mortality, length of stay, and cost. For non-ST-segment-elevation myocardial infarction, we saw a small reduction in sex disparity in the use of all diagnostic angiography in period 5 versus period 1 (4% versus 5.3%; P<0.01), no change in sex disparity in percutaneous coronary intervention use in period 5 versus period 1 (5.6% versus 5%; P=0.16), and a widening sex disparity in CABG in period 5 versus period 1 (5.4% versus 4.4%; P<0.01). However, we noted decreasing sex disparities in the use of diagnostic angiography, percutaneous coronary intervention, and CABG for ST-segment-elevation myocardial infarction in mostly all periods compared with period 1 (P<0.05, all comparisons), but differences still existed in period 5. Risk-adjusted in-hospital mortality was higher after CABG for non-ST-segment-elevation myocardial infarction and after percutaneous coronary intervention and CABG for ST-segment-elevation myocardial infarction in women than men. Conclusions Despite variable trends in sex disparities in diagnostic and revascularization procedures for acute myocardial infarction, disparities still exist.

Effectiveness and Safety of Atherectomy versus Plain Balloon Angioplasty for Limb Salvage in Tibioperoneal Arterial Disease.

PURPOSE: To evaluate the effectiveness and safety of atherectomy versus plain balloon angioplasty (POBA) for treatment of critical limb ischemia (CLI) due to tibioperoneal arterial disease (TPAD). MATERIALS AND METHODS: Patients enrolled in the Vascular Quality Initiative registry who had CLI (Rutherford Class 4-6) and underwent atherectomy versus POBA alone for isolated TPAD were retrospectively identified. Of eligible patients, a cohort of 2,908 patients was propensity matched 1:1 by clinical and angiographic characteristics. The atherectomy group comprised 1,454 patients with 2,183 arteries treated, and the POBA group comprised 1,454 patients with 2,141 arteries treated. The primary study endpoint was major ipsilateral limb amputation. Secondary endpoints were minor ipsilateral amputations, any ipsilateral amputation, primary patency, target vessel reintervention (TVR), and wound healing at 12 months. RESULTS: The median follow-up period was 507 days, the mean patient age was 69 years ± 11.7, and the mean occluded length was 6.9 cm ± 6.5. There was a trend toward higher technical success rates with atherectomy than with POBA (92.9% vs 91.0%, respectively; P = .06). The rates of major adverse events during the procedure were not significantly different. The 12-month major amputation rate was similar in the atherectomy and POBA groups (4.5% vs 4.6%, respectively; P = .92; odds ratio, 0.97; 95% CI, 0.68-1.37). There was no difference in 12-month TVR (17.9% vs 17.8%; P = .97) or primary patency (56.4% vs 54.5%; P = .64) between the atherectomy and POBA groups. CONCLUSIONS: In a large national registry, treatment of CLI from TPAD using atherectomy versus POBA showed no significant differences in procedural adverse events, major amputations, TVR, or vessel patency at 12 months.

Peripheral Artery Disease Intervention: Drug-Coated Balloon vs Drug-Eluting Stent, A Long-Term Comparison.

Objectives: The aim of the study is to evaluate current trends and long-term durability of both drug-eluting stents (DES) and drug-coated balloons (DCB) in the treatment of peripheral artery disease (PAD). Background: PAD affects more than 200 million people worldwide. Endovascular treatment of critical PAD has advanced in recent years. DES and DCB have demonstrated superiority compared to balloon angioplasty or bare metal stenting. The current literature lacks any long-term, direct comparison. Methods: A retrospective analysis was completed on patients who had femoral-popliteal interventions from June 2014 to June 2018 with either DCB or DES. Patient medical data and lesion characteristics were retrieved using the Vascular Quality Initiative database. Outcomes were analyzed through December 2019. Primary endpoint of time to clinical event-driven target lesion reintervention (TLR) and secondary endpoint of all-cause mortality were examined. Results: Four hundred eighty-three patients with a total of 563 interventions met the inclusion criteria. Three hundred fifty-nine DCB and 204 DES were performed. Of the DCBs, 132 required bailout stenting at the time of procedure. The mean time for TLR in the DES group was 1,277 days (SD 546), compared to 904 days (SD 330.1) for DCB. For patients requiring TLR, DES remained patent significantly longer (373 days longer on average) (p < 0.001). For all-cause mortality there was no significant difference at 50 months between DCB and DES (p = 0.06). Conclusions: In patients who required TLR, DES had a significantly longer length of time to reintervention vs DCB (average 373 days), although no difference in mortality was observed.

Monckeberg calcification of coronary arteries: a string of pearls.

Coronary artery calcium scores are derived from cardiac-gated noncontrast computed tomography scans that are used in cardiac risk stratification. However, an elevated calcium score does not always translate to coronary artery luminal obstruction. Our case demonstrates an extremely high coronary artery calcium score despite nonobstructive coronaries on angiogram.

Thirty-Day Readmission Rate Among Patients With Hypertensive Crisis: A Nationwide Analysis.

BACKGROUND: Hypertensive crisis is a life-threatening condition, further classified as hypertensive emergency and hypertensive urgency based on the presence or absence of acute or progressive end-organ damage, respectively. Readmissions in hypertensive emergency have been studied before. We aimed to analyze 30-day readmissions using recent data and more specific ICD-10-CM coding in patients with hypertensive crisis. METHODS: In a retrospective study using the National Readmission Database 2018, we collected data on 129,239 patients admitted with the principal diagnosis of hypertensive crisis. The primary outcome was the all-cause 30-day readmission rate. Secondary outcomes were common causes of readmission, in-hospital mortality, resource utilization, and independent predictors of readmission. We also compared outcomes between patients with hypertensive urgency and hypertensive emergency. RESULTS: Among 128,942 patients discharged alive, 13,768 (10.68%) were readmitted within 30 days; the most common cause of readmission was hypertensive crisis (19%). In-hospital mortality for readmissions (1.5%) was higher than for index admissions (0.2%, P < 0.01). Mean length of stay for readmissions was 4.5 days. The mean hospital cost associated with readmissions was $10,950, and total hospital costs were $151 million. Age <65 years and female sex were independent predictors of higher readmission rates. Subgroup analysis revealed a higher readmission rate for hypertensive emergency than hypertensive urgency (11.7% vs. 10%, P < 0.01). CONCLUSIONS: All-cause 30-day readmission rates are high in patients admitted with hypertensive crisis, especially patients with hypertensive emergency. Higher in-hospital mortality and resource utilization are associated with readmission in these patients.

Clinical Characteristics, Risk Factors, and Outcomes Among a Large Midwestern U.S. Cohort of Patients Hospitalized With COVID-19 Prior to Vaccine Availability.

Purpose: The COVID-19 pandemic posed unprecedented demands on health care. This study aimed to characterize COVID-19 inpatients and examine trends and risk factors associated with hospitalization duration, intensive care unit (ICU) admission, and in-hospital mortality. Methods: This retrospective study analyzed patients with SARS-CoV-2 infection hospitalized at an integrated health system between February 2, 2020, and December 12, 2020. Patient characteristics and clinical outcomes were obtained from medical records. Backward stepwise logistic regression analyses were used to identify independent risk factors of ICU admission and in-hospital mortality. Cox proportional hazards models were used to evaluate relationships between ICU admission and in-hospital mortality. Results: Overall, 9647 patients were analyzed. Mean age was 64.6 ± 18 years. A linear decrease was observed for hospitalization duration (0.13 days/week, R2=0.71; P<0.0001), ICU admissions (0.35%/week, R2=0.44; P<0.001), and hospital mortality (0.16%/week, R2=0.31; P<0.01). Bacterial co-infections, male sex, history of chronic lung and heart disease, diabetes, and Hispanic ethnicity were identified as independent predictors of ICU admission (P<0.001). ICU admission and age of ≥65 years were the strongest independent risk factors associated with in-hospital mortality (P<0.001). The in-hospital mortality rate was 8.3% (27.4% in ICU patients, 2.6% in non-ICU patients; P<0.001). Conclusions: Results indicate that, over the pandemic's first 10 months, COVID-19 carried a heavy burden of morbidity and mortality in older patients (>65 years), males, Hispanics, and those with bacterial co-infections and chronic comorbidities. Although disease severity has steadily declined following administration of COVID-19 vaccines along with improved understanding of effective COVID-19 interventions, these study findings reflect a "natural history" for this novel infectious disease in the U.S. Midwest.

National trends and variability of atherectomy use for peripheral vascular interventions from 2010 to 2019.

OBJECTIVE: Small, older studies have suggested that the use of atherectomy devices has become common in peripheral vascular interventions (PVIs) despite the paucity of strong clinical guidelines. We analyzed the 10-year trends in the use of atherectomy for PVIs across the United States and identified the main predictors of atherectomy use. METHODS: Using the Vascular Quality Initiative registry, we identified all patients who had undergone endovascular PVIs for occlusive lower extremity arterial disease from 2010 to 2019. Procedures in which an atherectomy device had been used as the primary or secondary device were classified as the atherectomy group. We calculated the frequency of atherectomy use over time and across geographic regions. Using regression modeling, we identified the factors that were independently associated with atherectomy use. RESULTS: A total of 205,377 PVIs had been performed for 152,693 unique patients. During the 10-year period, 16.6% of the PVI procedures had used atherectomy, increasing from 8.5% in 2010 to 19.7% in 2019 (Ptrend < .0001). Across 17 geographic regions, we found a significant difference in the prevalence of atherectomy use, ranging from 8.2% to 29%. The strongest predictor of atherectomy use was performance of PVI in an office setting (odds ratio [OR], 10.08; 95% confidence interval [CI], 9.17-11.09) or ambulatory center (OR, 4.0; 95% CI, 3.65-4.39) vs a hospital setting. The presence of severe (OR, 2.6; 95% CI, 2.4-2.85) or moderate (OR, 1.5; 95% CI, 1.4-1.69) lesion calcification was also predictive of atherectomy use. Other predictive factors included elective status, insurance provider, lesion length, prior PVI, claudication symptoms, and diabetes mellitus. CONCLUSIONS: Atherectomy use in PVI significantly increased from 2010 to 2019. We found wide regional variability in the use of atherectomy that seemed to be driven more strongly by nonclinical factors.

A Case of Transcatheter Aortic Valve Implantation in a Centenarian Patient.

Calcified aortic stenosis has become the most common form of acquired valvular heart disease in very old patients. Despite this fact, a majority of these patients were turned down by surgery owing to a risk of mortality > 10% in patients older than 90 years. In recent years, transcatheter aortic valve implantation (TAVI) has emerged as a therapeutic option for severe aortic stenosis. However, there is a paucity of data regarding the outcomes of TAVI in patients older than 100 years. We present the oldest patient who has undergone successful TAVI reported in the current literature.

Endovascular Treatment of Right Heart Masses Utilizing the AngioVac System: A 6-Year Single-Center Observational Study.

OBJECTIVE: To describe our institution's experience with the AngioVac system. BACKGROUND: Intracardiac and intravascular masses previously required surgical excision, but now, there are a number of minimally invasive options. With the advent of vacuum aspiration, more specifically the AngioVac System (AngioDynamics, NY, USA), there exists a system with both low mortality and minor complications. However, the number of retrospective studies remains limited. Outcome data for high-risk patients are also limited. METHODS: Data were collected and analyzed in patients who underwent AngioVac therapy at our tertiary care center from January 2014 to December 2020. RESULTS: Our results demonstrated a 93.3% intraoperative success rate and a 100% intraoperative survival rate. However, a number of complications, including but not limited to hematomas, anemia, and hypotension, occurred, as described below. CONCLUSIONS: Our experiences demonstrated good outcomes and continue to support the usefulness of the AngioVac System. The data also support the use of AngioVac as a treatment option for the debulking or removal of right heart masses in critically ill patients.

Business Cards as a Mechanism to Encourage Patient Feedback About Trainees.

This project sought to evaluate if business card distribution improved the utility of Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) surveys by serving as a feedback mechanism for trainees. Between fall 2018 and spring 2019, patient encounters for 6 cardiovascular disease fellows were tracked over two 60-day periods. Six weeks were allowed for HCAHPS surveys to be returned. Business cards were subsequently deployed and encounters similarly tracked. During the control-group monitoring period, 721 patient encounters were logged and 80 (11.1%) surveys were returned. Qualitative feedback, in the form of free-response comments, was provided in 41 (51.3%) surveys. Business cards were then deployed and encounters similarly tracked. During the business card period, 508 patient encounters occurred and 97 (19.1%) surveys were returned. Qualitative feedback was provided in 52 (53.6%) surveys. No fellow-specific feedback was returned in either group. Business card use by trainees was associated with an improved rate of survey return, from 11.1% to 19.1%, but no effect on feedback to fellows or patient satisfaction scores was found. HCAHPS surveys were not useful in providing trainees with feedback. Immediate verbal feedback from patients via ancillary staff was observed. A method of relaying communication from patients to ancillary staff and medical education programs is needed.