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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. Thirtyday 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.

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.

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.

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 Conclusion: The BTT-LVAD Score can serve as a clinical decision tool to guide therapeutic decisions in advanced heart failure patients.

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.

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.

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.

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.

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 shorter ICU stay and a higher rate of major vascular complication without an increase in life-threatening bleeding.

Background Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is being increasingly used to treat cardiogenic shock, however its effect on increasing left ventricular (LV) afterload may slow myocardial recovery and negatively affect survival. Percutaneous mechanical support devices have been utilized for LV unloading by reducing afterload in an attempt to improve outcomes. While the use of LV unloading devices remains debatable, its use has not been specifically studied in patients with non-acute myocardial infarction cardiogenic shock (non-AMICS). Purpose To study the outcomes of VA-ECMO with or without LV unloading devices in patients with non-AMICS patients. Methods National inpatient sample database from years 2015 to 2018 was queried to select patients admitted with non-AMICS. Patients were included in the study if they underwent VA-ECMO during admission and later categorized into 3 groups i.e. VA-ECMO, VA-ECMO plus Impella and VA-ECMO plus intra-aortic balloon pump (IABP). Baseline demographics and in-hospital outcomes were compared between the 3 pre-specified groups. Statistical significance was assigned at p Results 178,605 patients met criteria for non-AMICS. Of these, 2190 (1.23%) patients received VA-ECMO alone, 965 (0.54%) received VA-ECMO plus IABP and 414 (0.23%) received VA-ECMO plus Impella. On univariate analysis, patients who received VA-ECMO alone had higher rates of inpatient mortality as compared to those who received VA-ECMO plus IABP or VA-ECMO plus Impella (39.04%, 33.72% and 25.81% respectively, p=0.001). On multivariate analysis, the patients who received VA-ECMO plus IABP or VA-ECMO plus Impella had lower odds of mortality when compared to VA-ECMO alone (OR: 0.61 (0.39–0.96), p=0.03), OR: 0.51 (0.23–1.08), p=0.08). The length of stay and cost were significantly higher for patients with VA-ECMO with unloading devices (IABP or Impella) compared with VA-ECMO alone (24.77±2.44 and 27.74±3.55 days vs 23.70±1.25 days respectively. p=0.001, $846,404±71169 and 860,999±121942 vs $740,274±43644 respectively, p=0.001). Conclusions Non AMICS patients who received VA-ECMO along with LV unloading devices (esp IABP) had lower in-hospital mortality as compared to those who received VA-ECMO alone despite having longer length of stay and higher cost. Use of LV unloading devices like IABP or Impella may improve outcomes in patients requiring VA-ECMO support for non-myocardial infarction cardiogenic shock. Further studies are needed to identify specific patient subsets that may benefit from this approach. Funding Acknowledgement Type of funding sources: None.

Objectives To assess the safety and feasibility of percutaneous transaxillary (TAx) access for peripheral endovascular interventions. Background The common femoral artery (CFA) is the most commonly used access site for peripheral endovascular interventions. However, its use might be precluded in multiple circumstances. The axillary artery is comparable in size to the CFA and is less affected by atherosclerosis. Data regarding its percutaneous use in peripheral endovascular interventions are scarce. Methods Consecutive patients who underwent percutaneous TAx peripheral endovascular interventions were identified. Demographic and periprocedural data were extracted. Axillary artery access was obtained percutaneously with the arm abducted. A destination sheath was advanced to the relevant vessel. Endovascular interventions were performed using standard devices and techniques. Vascular closure devices were utilized to achieve hemostasis. Primary endpoints included procedural technical success, access-related complications, and major adverse events (MAEs). Secondary endpoints included cannulation time, total procedure time, fluoroscopy time, and length of stay (LOS). Results Percutaneous TAx access was successfully utilized to perform 41 procedures in 29 patients, lacking a suitable conventional access. Three quarters of target vessels were infrainguinal. The lesions of 61% were classified as TransAtlantic Inter-Society Consensus (TASC) C or D. Access-related complications occurred in two procedures (5%). No MAEs occurred. Median cannulation time was 12 min, procedure time 135 min, fluoroscopy time 20 min, and LOS 1 day. Conclusions When no suitable access exists for lower extremity catheter-based interventions, percutaneous TAx approach is a feasible and safe alternative. As such facility with this approach is a valuable asset for interventionalists.

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.

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

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.

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.

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.

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.

Left atrial appendage (LAA) closure devices are alternative treatments recently approved for patients with atrial fibrillation. Due to the novelty of these devices, limited postapproval surveillance data on LAA closure devices have been published. Thus, we analyzed the United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to report these findings. The primary endpoint was final event outcome, and secondary endpoints included management strategies of reported events.

OBJECTIVES We sought to describe the caliber and vascular health of the subclavian and axillary arteries as related to their potential utilization in complex cardiovascular procedures. BACKGROUND Patients referred for advanced catheter-based therapies frequently have lower extremity peripheral vascular disease that may prohibit the use of large bore arterial catheters. Utilization of the upper extremity peripheral vasculature is rarely considered as an alternative access strategy. This may be due in part to a lack of familiarity with the thoracic vasculature. METHODS AND RESULTS 208 consecutive patients undergoing routine CTA prior to transcatheter aortic valve replacement were retrospectively evaluated in a systematic analysis of upper and lower extremity vasculature. Minimal luminal diameters (MLDs) for the axillary arteries and iliofemoral arteries were 6.0 ± 1.1 mm and 6.6 ± 1.8 mm respectively. Compared to the iliofemoral arteries, the axillary arteries demonstrated substantially lower rates of significant stenosis (2% vs. 12%, p

Crossing of a critically stenosed aortic valve is a pivotal step during diagnostic cardiac catheterization to measure the transvalvular gradient, especially in patients with discordant clinical and echocardiographic findings and also during transcatheter aortic valve replacement procedures. However, there are no data in the literature indicating whether aortic valve crossing typically occurs during systole or diastole. We hypothesize that aortic valve crossing is a diastolic phenomenon and describe our technique for crossing critically stenosed aortic valves.

Purpose Patients awaiting heart transplant (HTx) with temporary mechanical circulatory support (tMCS) are at high risk of waitlist mortality and are accorded higher priority under the 2018 US adult heart allocation system. To examine the effect of policy changes on racial equity, we examined outcomes based on race in these high risk patients. Methods UNOS registry was queried for adults listed for heart transplant (HTx) 1-year before and after the October 18, 2018 policy change. We examined association of race with use of tMCS (IABP+ ECMO+ percutaneous LVAD+ surgical temporary LVAD), access to transplant organs within 1-year of listing in the pre- and post-era, and 1-year post-transplant mortality. Results Of 8,015 patients listed for HTx, 62.7 % were White and 37.3% Non-White. In the pre-policy era, 290 of 4,027 (7.2%) were listed with tMCS vs 649 of 3,988 (16.3%) in the post era (p Conclusion In the current allocation policy era, the proportion of non-White patients listed for HTx with tMCS appears to be lower compared to Non-White patients, the reasons for which need to be further elucidated. However, in patients who receive tMCS bridge, waitlist mortality, transplant rate, and 1-year post-transplant survival are similar, regardless of race.

The “preclose” technique employing two Perclose (P) devices is well established for large-bore artery (LBA) hemostasis. Occasionally, only one Perclose deploys successfully during the initial preclose because of arterial calcification necessitating the use of the crossover balloon technique to achieve hemostasis at the LBA. We sought to determine if the combined use of one Perclose and either one Angioseal or one Mynx vascular closure device (VCD) is a safe alternative closure technique large-bore arteriotomy closure.In total, 40 patients underwent high-risk percutaneous coronary intervention (HRPCI) with Impella support, of whom 38 had common femoral artery (CFA) arteriotomies and 2 underwent percutaneous axillary arteriotomy (AA). Prior to Impella insertion, one Perclose device was predeployed. At the end of HRPCI, Impella was removed and a 0.035″ wire was inserted through the Impella sheath. This sheath was then withdrawn over the wire, and partially deployed Perclose was fully deployed. A 6-Fr sheath was advanced over a 0.035″ wire into the CFA or AA, achieving hemostasis and reducing the LBA to a 6-Fr size. The 6-Fr arteriotomy was closed with a 6-Fr Mynx or Angioseal VCD. Patients were followed at day 1 and day 30.Hybrid closure was successful in 38 of 40 cases. In one case of Mynx balloon rupture, hemostasis was achieved with heparin reversal and manual compression. In the case of Perclose failure, crossover balloon tamponade at arteriotomy site and external manual compression achieved hemostasis. Patients were free of complications at day 1 and day 30.Hybrid closure with one Perclose and either one Mynx or one Angioseal VCD is safe and effective for LBA closure.

Contrary to popular wisdom, predominantly unilateral aortoiliac bifurcation disease can be safely treated with a single stent if the contralateral common iliac ostium is protected with matching balloon inflation. Larger studies on this novel approach with a longer clinical follow-up are needed to validate our results.

To identify a fluoroscopic bony landmark for safe percutaneous axillary artery cannulation.No bony landmarks exist to guide safe percutaneous axillary artery cannulation, which is an important alternate access site for catheter-based procedures in selected patients.We retrospectively analyzed 51 consecutive percutaneous axillary artery sheath angiograms and attempted to correlate a fixed bony landmark to the proximal end of the third part of the artery. Proximal to this site, no cords of the brachial plexus traverse the anterior aspect of the vessel. Moreover, this site is proximal to the subscapular branch of the axillary artery, the first branch of its third part, and a sentinel component of the scapular anastomosis responsible for collateral blood flow to the arm.With the arm abducted at 135°, the subscapular artery originated at, or distal to, the inferior border of the glenoid cavity, as seen on fluoroscopy in the anterior-posterior projection, in all patients. The origin was within 5 mm distal to the inferior border of the glenoid cavity in 17 patients (46%), 5-10 mm in 13 patients (35%), and between 10 mm and 20 mm in 7 patients (19%).With the arm abducted, the origin of the subscapular artery correlates well with the inferior-most aspect of the glenoid cavity of the scapula under fluoroscopy. Axillary artery cannulation medial to this bony landmark typically lands the sheath in the second part or proximal end of the third part of the artery, thereby theoretically sparing injury to the brachial plexus and the subscapular artery.

Tricuspid valve regurgitation (TR) is often not taken into consideration in the prognostication of patients undergoing transcatheter aortic valve replacement (TAVR). Accordingly, its impact on such patients remains relatively poorly defined. The study aim was to explore the effect of TR and parameters of right ventricular (RV) function on outcomes in patients undergoing TAVR.Baseline demographic and echocardiographic data were collected for 460 consecutive patients undergoing TAVR at the authors' institution between 2012 and 2015. A retrospective analysis was performed to determine the association of TR with all-cause mortality in these patients. The primary endpoint was 30-day rate of all-cause mortality and/or hospital re-admission.Among 460 patients included in the study analysis there were 25 deaths and 40 re-admissions. Univariate analysis showed that a higher Society of Thoracic Surgeons (STS) score, severe preoperative mitral and tricuspid regurgitation were associated with statistically significant higher 30-day mortality and/or re-admission rates. On multivariate analysis, STS score (OR 1.07, 95% CI 1.012-1.126), moderate TR (OR 3.24, 95% CI 1.52-6.87) and severe TR (OR 2.5, 95% CI 1.04-6.04) were identified as significant independent predictors of all-cause mortality.The severity of TR is a strong independent parameter predictive of death at 30 days. Therefore, parameters of RV function such as TR should be incorporated into predictive models for patients undergoing TAVR.

The axillary artery is an alternative, large-caliber vessel that can be utilized in the presence of hostile aortoiliac segments. It can accommodate sheaths up to 18 Fr and is infrequently affected by atherosclerosis.

Early randomized trials demonstrated that left atrial appendage closure (LAAC) with an LAAC device was equivalent to warfarin for preventing stroke in atrial fibrillation. There are limited published post-approval surveillance data on LAAC devices. We analyzed the U.S. Food and Drug Administration (

The Impella (Abiomed, Danvers, Massachusetts) is a minimally invasive axial-flow catheter capable of providing full temporary hemodynamic support. This study reports on a national series on the use of this device for bridge to decision in patients listed for heart transplantation. The authors

It is unknown whether endovascular intervention (EVI) is superior to surgical revascularization (SR) in patients with atrial fibrillation (AF). We sought to compare the outcome of limb revascularization using SR versus EVI in patients with AF. Using National Inpatient Sample database between 2002

Traditionally, brachial and common femoral arteries have served as access sites of choice, with many operators recently converting to radial artery access for coronary angiography and percutaneous intervention due to literature suggesting reduced bleeding risk, better patient outcomes, and lower hospital-associated costs. However, radial access has limitations when percutaneous procedures requiring larger sheath sizes are performed. Six Fr sheaths are considered the limit for safe use with the radial artery given that the typical luminal diameter of the vessel is approximately 2 mm, while peripheral artery disease (PAD) may often limit use of the common femoral artery, particularly in patients with multiple co-morbid risk factors. Similarly, the brachial artery has fallen out of favor due to both thrombotic and bleeding risks, while also not safely and reliably accommodating sheaths larger than 7 Fr. Here we describe 3 cases of a new entirely percutaneous technique utilizing the axillary artery for delivery of Impella 2.5 (13.5 Fr) and CP (14 Fr) cardiac-assist devices for protected percutaneous coronary intervention in the setting of prohibitive PAD.

Introduction: Based on the level of the great arch vessels take:off, three types of aortic arches (AA) have been described in humans, namely Type I, II and III. There are no definitive studies identifying the potential causation of these anatomical variations. We hypothesized that a continual downward drag of a vigorously beating hypertrophied heavier heart over time causes rightward aspect of aortic arch to shift caudad resulting in type II and III arches. Methods: We reviewed 111 consecutive CT scans of the chest with contrast in patients who also happened to have a 2D echocardiogram performed within the preceding year. AA type was determined by CT scan and then patients’ baseline characteristics and echocardiographic parameters including, but not limited to LV ejection fraction (LVEF), LV mass, LV mass index, LV weight (LV mass plus mass of blood contained in LV cavity) and relative wall thickness were analyzed. After the exclusion of bovine AA, complete data was available in 61 patients. The relationship between these variables and AA type was then tested in univariate and multivariate statistical models. Results: Univariate analysis revealed increased age, LV mass, LV weight, and LVPWd had significant correlation with Type II and III AAs. However, after multivariate analysis only increased age and LV weight remained independent predictors of AA type. Incidentally, 10 of 11 elderly patients with critical aortic stenosis being evaluated for TAVR had a Type III arch. Conclusion: Advanced age and LV weight (LV mass plus mass of blood contained in LV cavity) are the most powerful predictors of Type II/III AAs.

The use of transfemoral (TF) access for endovascular peripheral vascular procedures can be precluded in many occasions; such as hostile aortoiliac segments. The use of transradial access can be limited by the vessel size, distance from lesion and loss of support, and availability of tools with

Objective.The use of the axillary artery as an access site has lost favor in percutaneous intervention due to the success of these procedures from a radial or brachial alternative. However, these distal access points are unable to safely accommodate anything larger than a 7-French sheath. To date no studies exist describing the size of the axillary artery in relation to the common femoral artery in a patient population. We hypothesized that the axillary artery is of comparable size to the CFA in most patients and less frequently diseased.Methods.We retrospectively reviewed 110 CT scans of the thoracic and abdominal aorta done at our institution to rule out aortic dissection in which the right axillary artery, right CFA, left axillary artery, and left CFA were visualized. Images were then reconstructed using commercially available TeraRecon software and comparative measurements made of the axillary and femoral arteries.Results.In 96 patients with complete data, the mean sizes of the right and left axillary artery were slightly smaller than the left and right CFA. A direct comparison of the sizes of the axillary artery and CFA in the same patient yielded a mean difference of 1.69 mm ± 1.74. In all patients combined, the mean difference between the axillary artery and CFA was 1.88 mm on the right and 1.68 mm on the left. In 19 patients (19.8%), the axillary artery was of the same caliber as the associated CFA. In 8 of 96 patients (8.3%), the axillary artery was larger compared to the CFA.Conclusions.Although typically smaller, the axillary artery is often of comparable size to the CFA, significantly less frequently calcified or diseased, and in almost all observed cases large enough to accommodate a sheath with up to 18 French.

Patients referred for advanced catheter-based therapies frequently have lower extremity peripheral vascular disease that is prohibitive for the use of large bore arterial catheters. Utilization of upper extremity peripheral vasculature is rarely considered as an alternative access strategy. This may

The Impella© microaxial pump devices have been used widely in recent years. However, their utilization can be limited by inhospitable iliofemoral vessels or a desire to mobilize patients who require support for a prolonged period. Surgical exposure of the axillary artery is an alternative solution

The “pre-close” technique employing two Perclose (P) (Abott Vascular, CA) is well established for large-bore arteriotomy (LBA) closure. We theorized that using 1 P and 1 Mynx (M) (Accessclosure, CA) or Angioseal (A)(St. Jude Medical, MN) vascular closure device (VCD) in a hybrid closure (HC)

pro-apoptotic effects on plasma cells and thus decreases antibody production. In our case, bortezomib has shown efficacy as rescue therapy for recurrent AMR despite the fact that no DSAs have been detected. Beyond the treatment of AMR, bortezomib has also been used in desensitization therapies prior to transplantation. Bortezomib decreases levels of panel reactive antibodies (PRA) in sensitized patients. The patient has continued on a stable outpatient course at 12 months after treatment. The proteasome inhibitor–based therapy with bortezomib appears to be a promising therapeutic option for recurrent AMR.