Real-world approach to comprehensive artificial intelligence-aided CT evaluation of coronary artery disease in 530 patients: A retrospective study.

Purpose: Recent guidelines provide broader support for the use of less invasive imaging modalities for the evaluation of patients with stable chest pain. Coronary CT angiography (CCTA) uses increasingly sophisticated techniques to improve evaluation of coronary lesions. The purpose of this study is to describe one center's experience implementing AI-assisted advanced imaging techniques to diagnose coronary artery disease. Materials & methods: Retrospective study of patients who had AI-assisted CCTA interpretation, including a subgroup who underwent fractional flow reserve CT (FFR-CT) and invasive coronary angiography. Descriptive statistics summarized baseline characteristics and univariate statistics compared findings between groups of patients with and without anatomically and hemodynamically significant lesions based on FFR-CT. For patients who underwent invasive coronary angiography, concordance between CCTA and angiography was evaluated. Results: Of 532 included patients, AI-assisted CCTA identified statistically significant difference in calcification scores, plaque types and total plaque volume between lesions <50% and ≥50% stenosis. CCTA results were mostly concordant with invasive coronary angiography. Importantly, we identified a subset of patients with less than 50% anatomical stenosis that demonstrated physiologically significant stenosis on FFR-CT and invasive coronary angiography. Conclusions: AI-assisted CCTA and other advanced techniques are a tool to support high quality diagnostic assessment of coronary lesions in a clinical environment. Combined CCTA with FFRCT in mild to moderate coronary stenosis identifies patients with hemodynamically significant stenosis even when quantitative stenosis is <50%. Implementation of AI-assisted coronary CT angiography is feasible in a community hospital setting, but these technologies do not replace the need for expert review and clinical correlation.

Impact of frailty on outcomes in acute ST-elevated myocardial infarctions undergoing percutaneous coronary intervention.

AIMS: We analyzed the impact of frailty on readmission rates for ST-elevated myocardial infarctions (STEMIs) and the utilization of percutaneous coronary intervention (PCI) in STEMI admissions. METHODS AND RESULTS: The 2016-2019 Nationwide Readmission Database was analyzed for patients admitted with an acute STEMI. Patients were categorized by frailty risk and analyzed for 30-day readmission risk after acute STEMIs, PCI utilization and outcomes, and healthcare resource utilization. Qualifying index admissions were found in 584,918 visits. Low risk frailty was noted in 78.20%, intermediate risk in 20.67%, and high risk in 1.14% of admissions. Thirty-day readmissions occurred in 7.74% of index admissions, increasing with frailty (p < 0.001). Readmission risk increased with frailty, 1.37 times with intermediate and 1.21 times with high-risk frailty. PCI was performed in 86.40% of low-risk, 66.03% of intermediate-risk, and 58.90% of high-risk patients (p < 0.001). Intermediate patients were 55.02% less likely and high-risk patients were 61.26% less likely to undergo PCI (p < 0.001). Length of stay means for index admissions were 2.96, 7.83, and 16.32 days for low, intermediate, and high-risk groups. Intermediate and high-risk frailty had longer length of stay, higher total cost, and were more likely to be discharged to a skilled facility (p < 0.001). CONCLUSION: Among adult, all-payer inpatient visits, frailty discerned by the hospital frailty risk score was associated with increased readmissions, increased healthcare resource utilization, and lower PCI administration.

Clinical expert consensus document on the use of percutaneous left ventricular assist devices during complex high-risk PCI in India using a standardised algorithm.

Over the past decade, percutaneous left ventricular assist devices (pLVAD), such as the Impella microaxial flow pump (Abiomed), have been increasingly used to provide haemodynamic support during complex and high-risk revascularisation procedures to reduce the risk of intraprocedural haemodynamic compromise and to facilitate complete and optimal revascularisation. A global consensus on patient selection for the use of pLVADs, however, is currently lacking. Access to these devices is different across the world, thus, individual health care environments need to create and refine patient selection paradigms to optimise the use of these devices. The Impella pLVAD has recently been introduced in India and is being used in several centres in the management of high-risk percutaneous coronary intervention (PCI) and cardiogenic shock. With this increasing utilisation, there is a need for a standardised evaluation protocol to guide Impella use that factors in the unique economic and infrastructural characteristics of India's health care system to ensure that the needs of patients are optimally managed. In this consensus document, we present an algorithm to guide Impella use in Indian patients: to establish a standardised patient selection and usage paradigm that will allow both optimal patient outcomes and ongoing data collection.

Declining Trend of Transapical Access for Transcatheter Aortic Valve Replacement in Patients with Aortic Stenosis.

Introduction: The last decade has witnessed major evolution and shifts in the use of transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). Included among the shifts has been the advent of alternative access sites for TAVR. Consequently, transapical access (TA) has become significantly less common. This study analyzes in detail the trend of TA access for TAVR over the course of 7 years. Methods: The national inpatient sample database was reviewed from 2011-2017 and patients with AS were identified by using validated ICD 9-CM and ICD 10-CM codes. Patients who underwent TAVR through TA access were classified as TA-TAVR, and any procedure other than TA access was classified as non-TA-TAVR. We compared the yearly trends of TA-TAVR to those of non-TA-TAVR as the primary outcome. Results: A total of 3,693,231 patients were identified with a diagnosis of AS. 129,821 patients underwent TAVR, of which 10,158 (7.8%) underwent TA-TAVR and 119,663 (92.2%) underwent non-TA-TAVR. After peaking in 2013 at 27.7%, the volume of TA-TAVR declined to 1.92% in 2017 (p < 0.0001). Non-TA-TAVR started in 2013 at 72.2% and consistently increased to 98.1% in 2017. In-patient mortality decreased from a peak of 5.53% in 2014 to 3.18 in 2017 (p=0.6) in the TA-TAVR group and from a peak of 4.51% in 2013 to 1.24% in 2017 (p=0.0001) in the non-TA-TAVR group. Conclusion: This study highlights a steady decline in TA access for TAVR, higher inpatient mortality, increased length of stay, and higher costs compared to non-TA-TAVR.

Comparison of Suture-Based and Collagen-Based Vascular Closure Devices for Large Bore Arteriotomies-A Meta-Analysis of Bleeding and Vascular Outcomes.

BACKGROUND: Large bore access procedures rely on vascular closure devices to minimize access site complications. Suture-based vascular closure devices (S-VCD) such as ProGlide and ProStar XL have been readily used, but recently, newer generation collagen-based vascular closure devices (C-VCD) such as MANTA have been introduced. Data on comparisons of these devices are limited. METHODS: PubMed, Scopus and Cochrane were searched for articles on vascular closure devices using keywords, ("Vascular closure devices" OR "MANTA" OR "ProStar XL" OR "ProGlide") AND ("outcomes") that resulted in a total of 875 studies. Studies were included if bleeding or vascular complications as defined by Valve Academic Research Consortium-2 were compared between the two types of VCDs. The event level data were pooled across trials to calculate the Odds Ratio (OR) with 95% CI, and analysis was done with Review Manager 5.4 using random effects model. RESULTS: Pooled analyses from these nine studies resulted in a total of 3410 patients, out of which 2855 were available for analysis. A total of 1229 received C-VCD and 1626 received S- VCD. Among the patients who received C-VCD, the bleeding complications (major and minor) were similar to patients who received S-VCD ((OR: 0.70 (0.35-1.39), p = 0.31, I2 = 55%), OR: 0.92 (0.53-1.61), p = 0.77, I2 = 65%)). The vascular complications (major and minor) in patients who received C-VCD were also similar to patients who received S-VCD ((OR: 1.01 (0.48-2.12), p = 0.98, I2 = 52%), (OR: 0.90 (0.62-1.30), p = 0.56, I2 = 35%)). CONCLUSIONS: Bleeding and vascular complications after large bore arteriotomy closure with collagen-based vascular closure devices are similar to suture-based vascular closure devices.

Derivation and validation of the bridge to transplantation with left ventricular assist device score for 1 year mortality after heart transplantation. The BTT-LVAD score.

BACKGROUND: To derive and validate a risk score that accurately predicts 1-year mortality after heart transplantation (HT) in patients bridged to transplant (BTT) with a left ventricular assist device (LVAD). METHODS: The UNOS database was queried to identify patients BTT with an LVAD between 2008 and 2018. Patients with ⩾1-year follow up were randomly divided into derivation (70%) and validation (30%) cohorts. The primary endpoint was 1-year mortality. A simple additive risk score was developed based on the odds of 1-year mortality after HT. Risk groups were created, and survival was estimated and compared. RESULTS: A total of 7759 patients were randomly assigned to derivation (n = 5431) and validation (n = 2328) cohorts. One-year post-transplant mortality was 9.8% (n = 760). A 33-point scoring was created from six recipient variables and two donor variables. Risk groups were classified as low (0-5), intermediate (6-10), and high (>10). In the validation cohort, the predicted 1-year mortality was significantly higher in the high-risk group than the intermediate and low-risk groups, 14.7% versus 9% versus 6.1% respectively (log-rank test: p < 0.0001). CONCLUSION: The BTT-LVAD Score can serve as a clinical decision tool to guide therapeutic decisions in advanced heart failure patients.

Safety and Efficacy of the Amplatzer Septal Occluder: A Systematic Review and Meta-Analysis.

OBJECTIVES: To assess the safety and efficacy of the Amplatzer Septal Occluder in the closure of secundum type atrial septal defects. BACKGROUND: The Amplatzer Septal Occluder (ASO; Abbott, St. Paul, MN) is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). Previous small cohort trials have shown a favorable safety and technical efficacy profile. METHODS: We conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO's safety and implant efficacy. The primary endpoint was the technical success rate of implantations. Secondary outcomes included proportions of arrhythmias and embolism specific-adverse events. RESULTS: We included a total of 12 studies with 2972 patients. The ratio of device implantation was 2:1 by sex [female: male]. Pooled technical success rate of implantation was 98% (95% CI: 0.968-0.990, P < 0.01). The cumulative adverse event rate was 5.1% (95% CI: 0.035-0.068, P < 0.01), which included arrhythmia and embolism specific adverse event rates of 1.8% (95% CI: 0.007-0.032, P < 0.01) and 0.7% (95% CI: 0.002-0.013, P < 0.01), respectively. Sensitivity analysis did not significantly affect pooled outcomes for success rate and adverse events; both forest plot and Begg's and Egger's regression tests supported symmetricity. CONCLUSION: A high likelihood of technical success can be expected when implanting the ASO in secundum type ASDs. Adverse event rates are expected for one in twenty patients, and thus, our results support the safe use of ASO in secundum type ASDs closure. CONDENSED ABSTRACT: The AMPLATZER Septal Occluder is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). We conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO's safety and implant efficacy. We included a total of 12 studies with 2972 patients. Pooled technical success rate of implantation was 98% (P < 0.01). The cumulative adverse event rate was 5.1% (P < 0.01), 1.8% (P < 0.01) rate of arrhythmias, and 0.7% (P < 0.01) rate of embolisms. A high likelihood of technical success can be expected with a low rate of adverse events.

Acoustic Shock Waves to Modify Calcific Plaques - Intravascular Lithotripsy in the Peripheral Circulation.

Intravascular lithotripsy (IVL) is a new technique for treatment of severely calcified lesions that uses acoustic shockwaves in a balloon-based system to induce fracture in calcific plaque, facilitating luminal gain and vessel expansion. In this review, we provide a concise summary of the available data and clinical experience of IVL in various peripheral vascular beds, including facilitating vascular access for large-bore devices. We discuss the physics and mode of action of IVL in modifying calcified plaques, include several illustrative examples of utility of IVL in peripheral interventions, and discuss the future directions for adoption of the technique in peripheral interventions.

Percutaneous versus surgical transaxillary access for transcatheter aortic valve replacement: a propensity-matched analysis of the US experience.

BACKGROUND: As transaxillary (TAx) access has become the most common alternative to transfemoral (TF) transcatheter aortic valve replacement (TAVR), there is increasing use of a percutaneous approach. AIMS: This study sought to determine whether there are differences in outcomes using a percutaneous access versus cutdown for TAx TAVR. METHODS: Using data from the STS/ACC TVT Registry, consecutive patients undergoing TAx TAVR with balloon-expandable valves between July 2015 and December 2020 were included. Propensity score-based matching was performed to evaluate the association between method of TAx access and outcomes. RESULTS: Of 4,219 patients, 1,140 (27.0%) underwent percutaneous access and 3,079 (73.0%) had surgical cutdown for TAx TAVR, with the proportion of percutaneous cases increasing over time. After propensity matching, there were no significant baseline differences between patients undergoing TAx access by either approach. At 30 days, there were similar rates of all-cause mortality (4.8% in percutaneous patients vs 4.1% in surgical patients; p=0.40) and stroke (7.7% vs 6.5%; p=0.25). Those undergoing percutaneous TAx access were more likely to receive conscious sedation and have less need for the intensive care unit (ICU). Percutaneous access was associated with a higher rate of major vascular complication (3.0% vs 1.5% in surgical patients; p=0.02) but not life-threatening bleeding (0.3% vs 0.1%; p=0.31). CONCLUSIONS: This study supports the safety and efficacy of percutaneous TAx TAVR compared to traditional surgical cutdown. Percutaneous access was associated with a shorter ICU stay and a higher rate of major vascular complication without an increase in life-threatening bleeding.

Dry Field Closure of Large-Bore Access With Iliac Artery Angioplasty Through the Ipsilateral Sheath: The Single-Access Dry-Closure Technique.

The use of large-bore sheaths has risen exponentially in the last decade partly due to the growth of structural heart interventions and various mechanical circulatory support options. Meanwhile, the interventional community has gradually shifted from an open surgical to endovascular closure. However, vascular access complications and bleeding still remain a significant risk. Various techniques involving an additional access site have been described to allow for endovascular bailout of potential complications. However, these by themselves create an additional burden to procedural morbidity. Furthermore, the weight of additional procedural time, contrast, radiation and the need for advanced peripheral endovascular skills constitute considerable downsides to the "second arterial access" strategy. For that reason, we propose an alternative strategy, the "single-access dry-closure" technique, which provides vascular access control without the additional burden and risk of a second arterial access. This involves the use of low-pressure iliac artery occlusive angioplasty, delivered through the ipsilateral sheath during the endovascular closure. We hereby describe the steps, advantages and disadvantages of this novel technique. We also include the description of multiple technical variations depending on the use of one or two preclosed Proglide devices. This novel approach seems to be a safe, effective, simple, fast and economical technique that has the potential to decrease procedural morbidity by avoiding an additional arterial access. It also lowers contrast volume and radiation exposure while improving the overall set-up and operator ergonomics.

Characteristics, management, and outcomes among admissions for primary cardiac tumors: Results from the National Inpatient Sample.

INTRODUCTION: Primary cardiac tumors (PCT) are rare, and their contemporary outcomes are not well characterized in the literature. We assessed temporal trends in patient characteristics and management of admissions for PCT in US hospitals. METHODS: Admissions with the principal diagnoses of a PCT (benign neoplasm of heart: ICD-9 212.7, ICD-10 D15.1; malignant neoplasm of heart: ICD-9 164.1, ICD-10 C38.0) between 2006 and 2017 were extracted from the National Inpatient Sample. Trends in demographics and clinical profiles were evaluated. We conducted descriptive analyses on the cohort and compared outcomes between those managed medically and surgically. RESULTS: Between 2006 and 2017, 19,111 admissions had the primary diagnosis of a PCT. Of these, 91.1% were benign. Admissions were mostly female (65.0%), caucasian (72.0%), and aged more than 50 years (76.0%). The annual admission rate for PCT was similar from 2006 to 2017 (p trend > .05) and associated with congestive heart failure, diabetes, renal failure, and valvular lesions. PCTs were managed surgically in 12,811 (67.0%) of overall cases, 70.8% for benign and 28.3% for malignant tumors. Overall, the in-hospital mortality rate was 2.3%. Medically managed cases reported a 2.5% higher mortality (p < .001) than those surgically managed. Admissions with malignant tumors were more likely to expire during hospitalization than those with benign tumors (odds ratio, 9.75; 95% confidence interval 6.34-14.99; p < .001). CONCLUSION: Admissions for primary cardiac tumors were primarily women or in their fifth or sixth decade of life. Surgical intervention is more commonly practiced and is associated with better in-hospital survival.

Trends in Early Discharge and Associated Costs after Transcatheter Aortic Valve Replacement: A National Perspective.

OBJECTIVE: The current study aims to report trends of early discharges and identify associated direct costs using a nationally representative database of real-world data experience. METHODS: We used nationally weighted data on all patients who had transfemoral transcatheter aortic valve replacement (TAVR) from 2012 to 2017 and discharged alive from the National Inpatient Sample. Patients were divided into early (discharge ≤3 days of admission) and late discharge. Demographics and clinical characteristics were compared. Trends in early discharge and costs associated with admissions were analyzed over the study period. RESULTS: Of the 125,188 patients identified, 59,424 (46.9%) were discharged early. The proportion of early discharge increased from 15% in early 2012 to 68% in late 2017 (P < 0.001), with the largest increase occurring from 2014 to 2015. Overall, the average cost of TAVR decreased from $58,408 in 2012 to $49,875 in 2017 (P < 0.001). Compared to late discharge, patients discharged early reported costs savings of ≥$20,000 over the study period. Among the early discharge group, no significant differences in costs were observed for patients discharged on 0 to 1, 2, or 3 days after the procedure. CONCLUSIONS: Postoperative length of stay after TAVR has decreased dramatically within the last decade with an observed reduction in procedural costs. While discharge within 3 days appeared cost effective, no differences in costs were noted among patients discharged ≤3 days.

Mechanical Circulatory Support Devices: Management and Prevention of Vascular Complications.

The use of mechanical circulatory support devices has seen a dramatic rise over the last few years owing to their increased use not only in acute circulatory collapse but also their prophylactic use in high-risk procedures. These devices continue to have their overall benefits marginalized due to the relatively high rates of complications. Vascular complications are the most common and are associated with increased risk of mortality in these patients. Preventive measures at each stage of procedure, frequent monitoring and assessment to recognize early signs of deterioration are the best ways to mitigate the effects of vascular complications.

Change in Renal Function and Its Impact on Survival in Chronic Kidney Disease Patients Bridged to Heart Transplantation With a Left Ventricular Assist Device.

The study investigates the incidence of change in renal function and its impact on survival in renal dysfunction patients who were bridged to heart transplantation with a left ventricular assist device (BTT-LVAD). BTT-LVAD patients with greater than or equal to moderately reduced renal function (estimated glomerular filtration rate [eGFR] ≤ 60 ml/min/1.73 m2) at the time of listing between 2008 and 2018 were identified from a prospectively maintained database of the United Network for Organ Sharing. Patients with a baseline eGFR less than or equal to 15 ml/min/1.73 m2 or on dialysis were excluded. Patients were divided into three groups based on percent change ([Pretransplant eGFR - listing eGFR/listing glomerular filtration rate (GFR)] × 100) in eGFR: Improvement greater than or equal to 10%, no change, decline greater than or equal to 10%, and their operative outcomes were compared. Posttransplant survival was estimated and compared among the three groups with the Kaplan-Meier survival curves and the log-rank test. Cox proportional hazards modeling was used to identify predictors of posttransplant survival. Out of 14,395 LVAD patients, 1,622 (11%) met the inclusion criteria. At the time of transplant, 900 (55%) had reported an improvement in eGFR greater than or equal to 10%, 436 (27%) had no change, and 286 (18%) experienced a decline greater than or equal to 10%. Postoperatively, the incidence of dialysis was higher in the decline than in the unchanged or improved groups (22% vs. 12% vs. 12%; p = 0.002). After a median follow-up of 5 years, there was no difference in posttransplant survival among the stratified groups (improved eGFR: 24.8%, unchanged eGFR: 23.2%, declined eGFR: 20.3%; p = 0.680). On Cox proportional hazard modeling, independent predictors of worse survival were: [hazard ratio: 95% CI; p] history of diabetes (1.43 [1.13-1.81]; p = 0.002) or tobacco use (1.40 [1.11-1.79]; p = 0.005) and ischemic time greater than 4 hours (1.36 [1.03-1.76]; p = 0.027). More than half of the patients with compromised renal function who undergo BTT-LVAD demonstrate an improvement in renal function at the time of transplant. A 10% change in GFR while listed was not associated with worse posttransplant survival.

Outcomes of Obese Patients Bridged to Heart Transplantation with a Left Ventricular Assist Device.

The current study aims to investigate the impact of left ventricular assist device (LVAD) implantation on weight loss and functional status in obese patients bridged to transplantation (BTT). The United Network for Organ Sharing (UNOS) database was queried to identify patients with body mass index (BMI) ≥ 30 who underwent LVAD implantation as BTT from 2008 to 2018. Patients were divided into three groups based the World Health Organization classification of obesity: obesity class I (BMI, 30.0-34.9 kg/m2), obesity class II (BMI, 35-39.9 kg/m2), and obesity class III (BMI, >40 kg/m2). Patients with incomplete data on BMI were excluded. The primary outcome was a change in BMI while listed. Secondary outcomes included a change in functional status after LVAD implantation and posttransplant morbidity and survival. Out of 14,191 patients who had an LVAD while listed within the study period, 5,354 (37.7%) had a BMI ≥30 kg/m2. Obesity was classified as class I in 3,909 (73%), class II in 1,275 (23.8%), and class III in 170 (3.2%) patients. Among patients with complete data on BMI, 18.9% (n = 394) reported a change in BMI, leading to an improvement in their obesity class, and this was similar for all obesity classes (22% [n = 331], 50% [n = 111], and 60% [n = 43] for classes I, II, and III, respectively). All groups reported an improvement in functional status (65% vs. 62% and 61% for classes I, II, and III, respectively). Posttransplant survival was not significantly different between obese groups (p = 0.787). Compared with classes I and II, the incidence of thrombosis (p = 0.0006) and device malfunction (p = 0.036) was significantly higher in the class III group. About one out of every five obese patients listed for heart transplantation with an LVAD loses weight, leading to a change in their BMI class. Most patients reported a significant improvement in their functional status. Among those successfully BTT, posttransplant survival was similar.

Intravascular Lithotripsy Enabled Transfemoral Transcatheter Aortic Valve Implantation via Percutaneous Axillary Access Approach.

Transfemoral (TF) access for transcatheter aortic valve implantation (TAVI) is the most commonly used site, however its use may be limited by prohibitive peripheral arterial disease. Although a number of alternative access techniques have been well described, each has been shown to be associated with increased risks when compared to a TF approach. Recently, planned treatment of iliofemoral artery disease using intravascular lithotripsy (IVL) has emerged as a means of preserving TF access. Ipsilateral or contralateral femoral artery access has been routinely used to perform IVL but its use may be limited in certain conditions. Here we describe the novel technique of using percutaneous axillary artery access to perform IVL of iliofemoral artery to facilitate its use for large bore access. We present a 78-year-old high surgical risk female with severe aortic stenosis who was found to have a prior stent in the contralateral iliac artery protruding into the aorta which limited a traditional 'up and over' approach, and thus axillary artery access was used to perform IVL. This is the first case in literature to describe the use of percutaneous axillary access to perform IVL of the iliac and common femoral artery to facilitate TF TAVI. Based on our previous experience we feel this technique holds promise for a routine use when use of other access sites is limited.

Percutaneous large-bore axillary access is a safe alternative to surgical approach: A systematic review.

OBJECTIVES: To systematically review relevant literature regarding cardiovascular outcomes of large-bore axillary arterial access via percutaneous and surgical approaches. BACKGROUND: In patients with severe peripheral arterial disease (PAD) undergoing cardiac interventions, large-bore femoral access may be prohibitive. The axillary artery provides an alternative vascular access for transcatheter aortic valve replacement (TAVR) or mechanical circulatory support. There have been limited comparisons of percutaneous transaxillary (pTAX) approach with the more traditional surgical transaxillary (sTAX) approach. METHODS: Pubmed and Medline databases were queried through January 2019 for studies describing pTAX or sTAX approaches with TAVR or Impella insertion. Primary outcomes were access-related mortality, 30-day mortality, stroke, major vascular complications, and major bleeding. RESULTS: One hundred and fifty five studies were reviewed, with additional unpublished data from 1 institution. Twenty-two studies met the inclusion criteria. Patient data was heterogeneous, with 69% TAVR and 31% Impella use in the pTAX group, and 96% TAVR and 4% Impella use in the sTAX group. There was more cardiogenic shock in the pTAX group. When compared to surgical approach, the percutaneous approach had similar 30-day mortality for TAVR (5.6% vs 4.6%, OR non-significant) and Impella (43.4% vs 38.6%, OR non-significant), similar stroke rates (4.3% vs 4.2%, OR non-significant), similar major vascular complications (2.8% vs 2.3%, OR non-significant) and less major bleeding (2.7% vs 17.9%, OR significant). CONCLUSIONS: Data suggests large-bore pTAX access has similar 30-day mortality, stroke rates, and major vascular complications as sTAX access, with less major bleeding. Additional studies are needed to validate results.

Efficacy of Manual Hemostasis for Percutaneous Axillary Artery Intra-Aortic Balloon Pump Removal.

BACKGROUND: The prevalence of peripheral vascular disease has led to the re-emergence of percutaneous axillary vascular access as a suitable alternative access site to femoral artery. We sought to investigate the efficacy and safety of manual hemostasis in the axillary artery. METHODS: Data were collected from a prospective internal registry of patients who had a Maquet® (Rastatt, Germany) Mega 50 cc intra-aortic balloon pumps (IABP) placed in the axillary artery position. They were anticoagulated with weight-based intravenous heparin to maintain an activated partial thromboplastin time (aPTT) of 50-80 seconds. Anticoagulation was discontinued 2 hours prior to the device explantation. Manual compression was used to achieve the hemostasis of the axillary artery. Vascular and bleeding complications attributable to manual hemostasis were classified based on the Valve Academic Research Consortium-2 (VARC-2) and Bleeding Academic Research Consortium-2 (BARC-2) classifications, respectively. RESULTS: 29 of 46 patients (63%) achieved axillary artery homeostasis via manual compression. The median duration of IABP implantation was 12 days (range 1-54 days). Median compression time was 20 minutes (range 5-60 minutes). There were no major vascular or bleeding complications as defined by the VARC-2 and BARC-2 criteria, respectively. CONCLUSION: Manual compression of the axillary artery appears to be an effective and safe method for achieving hemostasis. Large prospective randomized control trials may be needed to corroborate these findings.