Percutaneous transaxillary access for endovascular aortic procedures in the multicenter international PAXA registry.

BACKGROUND: The aim of the study was to demonstrate the safety and effectiveness of a suture-mediated vascular closure device to perform hemostasis after an axillary artery access during endovascular procedures on the aortic valve, the aorta and its side branches. METHODS: A physician-initiated, international, multicenter, retrospective registry was designed to evaluate the success rate (VARC-2 reporting standards) of percutaneous transaxillary access closure with a suture-mediated closure device. Secondary end points were minor access vascular complications, transient peripheral nerve injury, stroke, and influence on periprocedural outcomes of puncture technique. RESULTS: Three hundred thirty-one patients (median age, 76 years; 69.2% males) in 11 centers received a percutaneous transaxillary access during endovascular cardiac (n = 166) or vascular (n = 165) procedures. The closure success rate was 84.6%, with 5 open conversions (1.5%), 45 adjunctive endovascular procedures (13.6%), and 1 nerve injury (0.3%). Secondary closure success was obtained in 325 patients (98%) after 7 bare stenting, 37 covered stenting, and 1 thrombin injection. Introducer sheaths 16F or larger (odds ratio, 3.70; 95% confidence interval, 1.22-11.42) and balloon-assisted hemostasis (odds ratio, 4.45; 95% confidence interval, 1.27-15.68) were associated with closure failure. A threshold of five percutaneous axillary accesses was associated with decreased rates of open conversion, but not with increased primary closure success. Primary closure success was 90.3% in the 175 patients with sheaths smaller than 16F, performed after the first 5 procedures in each center. Temporary nerve injury and stroke were observed in 2% and 4% of patients, respectively. CONCLUSIONS: Percutaneous transaxillary aortic procedures, in selected patients, can be performed with low rates of open conversion. The need for additional endovascular bailout procedures is not negligible when introducers sheaths 16F or larger are required.

Rates and impact of vascular complications in mechanical circulatory support.

BACKGROUND: Mechanical circulatory support (MCS) devices are increasingly used for hemodynamic support in cardiogenic shock or high-risk percutaneous coronary interventions. Vascular complications remain a major source of morbidity and mortality despite technological advances with percutaneous techniques. Little is known about the rates and predictors of vascular complications with large-bore access MCS in the contemporary era. METHODS: The study cohort was derived from National Inpatient Sample using data from 2015 to 2019 for cardiac hospitalizations with the use of: intra-aortic balloon pump (IABP) Impella, and/or extracorporeal membrane oxygenation (ECMO). The rates of vascular complications and in-hospital outcomes were analyzed using multivariable logistic regression. RESULTS: Of 221,700 hospitalizations with MCS use, the majority had only IABP (68%). The rates of vascular complications were greatest with ECMO (15.8%) when compared with IABP (3.0%) and Impella (5.6%). Among patients with vascular complications, in-hospital mortality was higher with ECMO (56.3%) when compared with IABP (26.2%) and Impella (33.8%). Peripheral arterial disease (PAD) was the strongest predictor of vascular complications, with 10 times higher odds when present (adjusted odds ratio [aOR] 10.96, p < 0.001). In risk-adjusted models, when compared with IABP, the use of Impella (aOR: 1.73, p < 0.001), ECMO (aOR: 5.35, p < 0.001), or a combination of MCS devices (aOR: 3.47, p < 0.001) was associated with higher odds of vascular complications. CONCLUSIONS: In contemporary practice, the use of MCS is associated with significant vascular complications and in-hospital mortality. Predictors of vascular complications include larger arteriotomy size, female gender, and peripheral arterial disease. Vascular access management remains essential to prevent major complications.

Clinical features and outcomes in patients with cardiogenic shock complicating acute myocardial infarction: early vs recent experience with impella.

OBJECTIVES: To compare clinical features and outcomes in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) treated in the early experience with Impella percutaneous ventricular assist device and patients treated recently. BACKGROUND: Since pre-market approval (PMA) of Impella device as treatment for AMICS, use of the device has grown considerably. METHODS: We retrospectively analyzed 649 AMICS patients treated with perioperative Impella, with 291 patients treated from 2008 to 2014 comprising the early experience cohort and 358 patients treated from 2017 to 2019 comprising the recent experience cohort. The primary end point was risk adjusted in-hospital mortality. RESULTS: Mean age and gender distribution of patients was similar in the two cohorts. The recent cohort had more invasive hemodynamic monitoring (64% vs 46%; P < .001) and less use of an intra-aortic balloon pump prior to Impella (15% vs 41%; P < .001). Recently treated patients were significantly more likely to receive Impella support prior to PCI (58% vs 44%; P = .005). In-hospital mortality was lower in the recent cohort (48% vs 56%; P = .043). This difference was however no longer significant after risk adjustment (adjusted OR 0.89, 95% CI 0.59-1.34, P = .59). Rates of acute kidney injury, major bleeding, and vascular complications requiring surgery were also significantly lower in the recent cohort. CONCLUSIONS: Use of Impella for AMICS during recent years is associated with lower unadjusted in-hospital mortality, which may reflect better patient selection, earlier device implantation, and improved management algorithms. In-depth understanding of these factors may inform the development of future treatment protocols.

Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction.

BACKGROUND: In ST-segment-elevation myocardial infarction (STEMI), infarct size correlates directly with heart failure and mortality. Preclinical testing has shown that, in comparison with reperfusion alone, mechanically unloading the left ventricle (LV) before reperfusion reduces infarct size and that 30 minutes of unloading activates a cardioprotective program that limits reperfusion injury. The DTU-STEMI pilot trial (Door-To-Unload in STEMI Pilot Trial) represents the first exploratory study testing whether LV unloading and delayed reperfusion in patients with STEMI without cardiogenic shock is safe and feasible. METHODS: In a multicenter, prospective, randomized exploratory safety and feasibility trial, we assigned 50 patients with anterior STEMI to LV unloading by using the Impella CP followed by immediate reperfusion (U-IR) versus delayed reperfusion after 30 minutes of unloading (U-DR). The primary safety outcome was a composite of major adverse cardiovascular and cerebrovascular events at 30 days. Efficacy parameters included the assessment of infarct size by using cardiac magnetic resonance imaging. RESULTS: All patients completed the U-IR (n=25) or U-DR (n=25) protocols with respective mean door-to-balloon times of 72 versus 97 minutes. Major adverse cardiovascular and cerebrovascular event rates were not statistically different between the U-IR versus U-DR groups (8% versus 12%, respectively, P=0.99). In comparison with the U-IR group, delaying reperfusion in the U-DR group did not affect 30-day mean infarct size measured as a percentage of LV mass (15±12% versus 13±11%, U-IR versus U-DR, P=0.53). CONCLUSIONS: We report that LV unloading using the Impella CP device with a 30-minute delay before reperfusion is feasible within a relatively short time period in anterior STEMI. The DTU-STEMI pilot trial did not identify prohibitive safety signals that would preclude proceeding to a larger pivotal study of LV unloading before reperfusion. An appropriately powered pivotal trial comparing LV unloading before reperfusion to the current standard of care is required. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03000270.

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.

In-hospital outcome of peripheral vascular intervention in dialysis-dependent end-stage renal disease patients.

BACKGROUND: The impact of end-stage renal disease (ESRD) on peripheral vascular intervention (PVI) outcome remains incompletely elucidated. OBJECTIVES: We sought to compare the outcome of PVI in dialysis patients with those with normal kidney function. METHODS: Using weighted data from the National Inpatient Sample database between 2002 and 2014, we identified all peripheral artery disease (PAD) patients aged ≥18 years that underwent PVI. Multivariate logistic regression analysis was performed to examine in-hospital outcomes. RESULTS: Of 1,186,192 patients who underwent PVI, 1,066,830 had normal kidney function (89.9%) and 119,362 had ESRD requiring dialysis (10.1%). Critical limb ischemia was more prevalent in dialysis patients (63.2 vs. 34.0%, p < .001). Compared with normal kidney function group, ESRD requiring dialysis was associated with higher in-hospital mortality (1.5 vs. 4.2%, adjusted OR: 2.13 [95% CI: 2.04-2.23]) and longer length of hospital stay (median 3 days, Interquartile range [IQR] (0-6) vs. 7 days, IQR (4-18); p < .001). Dialysis patients had higher incidence of major adverse cardiovascular events (composite of death, myocardial infarction, or stroke; 14.3 vs. 9.8%, p < .001) and net adverse cardiovascular events (composite of MACE, major bleeding, or vascular complications; 40.8 vs. 29.1%, p < .001). ESRD patients less frequently underwent open bypass (5.6 vs. 8.5%, p < .001) and more frequently had major amputation (10.3 vs. 3.0%, p < .001) compared with normal kidney function group. CONCLUSION: PAD patients on dialysis who underwent PVI have higher rates of mortality and adverse outcomes as compared to those with normal kidney function.

Sex-related difference in the use of percutaneous left ventricular assist device in patients undergoing complex high-risk percutaneous coronary intervention: Insight from the cVAD registry.

OBJECTIVE: To assess the in-hospital and short-term outcome differences between males and females who underwent high-risk PCI with mechanical circulatory support (MCS). BACKGROUND: Sex differences have been noted in several percutaneous coronary intervention (PCI) series with females less likely to be referred for PCI due increased risk of adverse events. However, data on sex differences in utilization and outcomes of high-risk PCI with MCS is scarce. METHODS: Using the cVAD Registry, we identified 1,053 high-risk patients who underwent PCI with MCS using Impella 2.5 or Impella CP. Patients with cardiogenic shock were excluded. A total of 792 (75.21%) males and 261 (24.79%) females were included in the analysis with median follow-up of 81.5 days. RESULTS: Females were more likely to be African American, older (72.05 ± 11.66 vs. 68.87 ± 11.17, p < .001), have a higher prevalence of diabetes (59.30 vs. 49.04%, p = .005), renal insufficiency (35.41 vs. 27.39%, p = .018), and peripheral vascular disease (31.89 vs. 25.39%, p of .05). Women had a higher mean STS score (8.21 ± 8.21 vs. 5.04 ± 5.97, p < .001) and lower cardiac output on presentation (3.64 ± 1.30 vs. 4.63 ± 1.49, p < .001). Although women had more comorbidities, there was no difference in in-hospital mortality, stroke, MI or need for recurrent revascularization compared to males. Females were more likely to have multivessel revascularization than males. Ejection fraction improved in both males and females at the time of discharge (26.59 to 31.40% and 30.75 to 36.05%, respectively, p < .0001). However, females had higher rate of bleeding requiring transfusion compared with males (9.58 vs. 5.30%, p = .019). CONCLUSION: Female patients undergoing high PCI were older and had more comorbidities but had similar outcomes compared to males.

Impella support and acute kidney injury during high-risk percutaneous coronary intervention: The Global cVAD Renal Protection Study.

BACKGROUND: Protection against acute kidney injury (AKI) has been reported with the use of Impella during high-risk percutaneous coronary intervention (HR-PCI). We sought to evaluate this finding by determining the occurrence of AKI during Impella-supported HR-PCI in patients from the Global cVAD Study and compare this incidence with their calculated AKI risk at baseline. METHODS AND RESULTS: In this prospective, multicenter study, we enrolled 314 consecutive patients. We included 223 patients that underwent nonemergent HR-PCI supported with Impella 2.5 or Impella CP and excluded those requiring hemodialysis prior to HR-PCI (19) and those with insufficient data (72). The primary outcome was AKI postprocedurally at 48 hr versus the predicted risk of AKI according to Mehran risk score. Logistic regression analysis determined predictors of AKI. Overall, 4.9% (11) of Impella-supported patients developed AKI (exclusively stage 1) at 48 hr versus a predicted rate of 21.9%, representing a 77.6% lower AKI rate (p < .0001). In this study, no Impella-supported patients required renal replacement therapy. Estimated glomerular filtration rate (ml/min/1.73 m2 ) alone predicted AKI (adjusted odds ratio [AOR]: 4.915; 95% confidence intervals [CI]: 1.02-23.53, p = .046), and increasing contrast had insignificant effects on AKI during high-risk PCI (AOR: 1.15; 95% CI: 0.87-1.51, p = .332). In patients not protected from AKI, the postprocedure incidence of AKI was not significantly greater and did not correlate with chronic kidney disease severity. CONCLUSION: The incidence of AKI was lower during HR-PCI than expected from current risk models. Although further exploration of this finding is warranted, these data support a new protective strategy against AKI during HR-PCI.

Outcomes of nonemergent percutaneous coronary intervention requiring mechanical circulatory support in patients without cardiogenic shock.

BACKGROUND: The utilization of mechanical circulatory support (MCS) for percutaneous coronary intervention (PCI) using percutaneous ventricular assist device (PVAD) or intra-aortic balloon pump (IABP) has been increasing. We sought to evaluate the outcome of coronary intervention using PVAD compared with IABP in noncardiogenic shock and nonacute myocardial infarction patients. METHOD: Using the National Inpatient Sampling (NIS) database from 2005 to 2014, we identified patients who underwent PCI using ICD 9 codes. Patients with cardiogenic shock, acute coronary syndrome, or acute myocardial infarction were excluded. Patient was stratified based on the MCS used, either to PVAD or IABP. Univariate and multivariate logistic regression were performed to study PCI outcome using PVAD compared with IABP. RESULTS: Out of 21,848 patients who underwent PCI requiring MCS, 17,270 (79.0%) patients received IABP and 4,578 (21%) patients received PVAD. PVAD patients were older (69 vs. 67, p < .001), were less likely to be women (23.3% vs. 33.3%, p < .001), and had higher rates of hypertension, diabetes, hyperlipidemia prior PCI, prior coronary artery bypass graft surgery, anemia, chronic lung disease, liver disease, renal failure, and peripheral vascular disease compared with IABP group (p ≤ .007). Using Multivariate logistic regression, PVAD patients had lower in-hospital mortality (6.1% vs. 8.8%, adjusted odds ratio [aOR] 0.62; 95% CI 0.51, 0.77, p < .001), vascular complications (4.3% vs. 7.5%, aOR 0.78; 95% CI 0.62, 0.99, p = .046), cardiac complications (5.6% vs. 14.5%, aOR 0.29; 95% CI 0.24, 0.36, p < .001), and respiratory complications (3.8% vs. 9.8%, aOR 0.37; 95% CI 0.28, 0.48, p < .001) compared with patients who received IABP. CONCLUSION: Despite higher comorbidities, nonemergent PCI procedures using PVAD were associated with lower mortality compared with IABP.

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.

Ex-vivo percutaneous bypass: Limb perfusion in the setting of occlusive large bore sheath.

Successful cardiac catheterization procedure begins with safe vascular access and ends with effective hemostasis after equipment removal. These new and advanced technologies in the cath lab require large-bore arterial accesses. Large-bore sheaths are associated with blood flow obstruction resulting in limb ischemia. In this case we present a 48-year-old woman was admitted NSTEMI and cardiogenic shock requiring mechanical circulatory support. Selective left common iliac angiography demonstrated obstructive flow at the level of the left CFA (access site). Therefore, ipsilateral bypass circuit was done. The current case illustrates the utility of a temporary ex-vivo bypass circuit to preserve limb perfusion in the presence of an occlusive large bore sheath. The technique permits sufficient hemodynamic support while maintaining limb perfusion and can be used for any occlusive large bore sheath.

Large bore occlusive sheath management.

The field of interventional cardiology has evolved in its ability to carry out complex procedures. Procedures such as transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR), and mechanical circulatory support (MCS) devices require large bore access for successful deployment. With the use of large bore-access, comes with it an increased risk for vascular complications, such as thrombosis and limb ischemia. It is paramount for the interventional cardiologist to know how to manage such complications. In this manuscript, we describe our strategies for the management of occlusive sheaths increasingly encountered with large bore accesses in the upper and lower extremities. Strategies such as peeling away of the introducer sheath and the creation of internal and external bypass circuits are described. By using the described techniques, one can provide prolonged hemodynamic support and maintain large bore sheath access, without jeopardizing perfusion to the extremity.

Improved Outcomes Associated with the use of Shock Protocols: Updates from the National Cardiogenic Shock Initiative.

BACKGROUND: The National Cardiogenic Shock Initiative is a single-arm, prospective, multicenter study to assess outcomes associated with early mechanical circulatory support (MCS) in patients presenting with acute myocardial infarction and cardiogenic shock (AMICS) treated with percutaneous coronary intervention (PCI). METHODS: Between July 2016 and February 2019, 35 sites participated and enrolled into the study. All centers agreed to treat patients with AMICS using a standard protocol emphasizing invasive hemodynamic monitoring and rapid initiation of MCS. Inclusion and exclusion criteria mimicked those of the "SHOCK" trial with an additional exclusion criteria of intra-aortic balloon pump counter-pulsation prior to MCS. RESULTS: A total of 171 consecutive patients were enrolled. Patients had an average age of 63 years, 77% were male, and 68% were admitted with AMICS. About 83% of patients were on vasopressors or inotropes, 20% had a witnessed out of hospital cardiac arrest, 29% had in-hospital cardiac arrest, and 10% were under active cardiopulmonary resuscitation during MCS implantation. In accordance with the protocol, 74% of patients had MCS implanted prior to PCI. Right heart catheterization was performed in 92%. About 78% of patients presented with ST-elevation myocardial infarction with average door to support times of 85 ± 63 min and door to balloon times of 87 ± 58 min. Survival to discharge was 72%. Creatinine ≥2, lactate >4, cardiac power output (CPO) <0.6 W, and age ≥ 70 years were predictors of mortality. Lactate and CPO measurements at 12-24 hr reliably predicted overall mortality postindex procedure. CONCLUSION: In contemporary practice, use of a shock protocol emphasizing best practices is associated with improved outcomes.

Association Between Underweight Body Mass Index and In-Hospital Outcome in Patients Undergoing Endovascular Interventions for Peripheral Artery Disease: A Propensity Score Matching Analysis.

PURPOSE: To investigate in-hospital outcomes after endovascular therapy (EVT) in patients with severe peripheral artery disease (PAD) who had a low body mass index (BMI, kg/m2) compared to those with normal BMI. MATERIALS AND METHODS: Using weighted data from the National Inpatient Sample (NIS) database between 2002 and 2014 and ICD-9 codes, 2614 patients were identified who were aged ≥18 years and underwent EVT for PAD in the lower limb vessels. EVT was defined as angioplasty, atherectomy, and/or stenting. After excluding individuals with BMI >24, there were 807 (31%) normal-weight (BMI 19-24) patients and 1807 (69%) underweight (BMI <19) individuals. All patients in both groups were matched for baseline demographic and clinical characteristics and critical limb ischemia in a 1:1 propensity score matching analysis using the nearest neighbor method. RESULTS: Propensity score matching produced 2 groups of 685 patients that differed only in the incidence of chronic lung disease, which was more frequent in low-BMI patients (p=0.04). Patients with low BMI had a higher incidence of in-hospital mortality (4.8% vs 1.2%, p<0.001), major adverse cardiovascular events (composite of death, myocardial infarction, or stroke) (7.9% vs 4.1%, p=0.003), open bypass surgery (9.1% vs 6.0%, p=0.03), and infection (14.6% vs 10.5%, p=0.02) compared with the normal-BMI group. There was no significant difference in the incidence of vascular complications (p=0.31), major bleeding (p=0.17), major amputation (p=0.35), or acute kidney injury (p=0.09) between the low- and normal-BMI groups. CONCLUSION: Low-BMI patients with PAD have worse in-hospital survival and more adverse outcomes after EVT.

Catheter-directed therapy for acute pulmonary embolism in children.

BACKGROUND: Acute pulmonary embolism is a life-threatening condition and rarely occurs in children. In adults, catheter-directed therapy emerges as a potentially safer and effective therapeutic option. However, there is a paucity of data on the safety and efficacy of catheter-directed therapy for pulmonary embolism in children. We report a single-centred experience of catheter-directed therapy for acute pulmonary embolism in children. METHODS: This is a retrospective study of children who had no CHD and underwent catheter-directed therapy at Detroit Medical Center during a 12-year period from 2005 to 2017. Demographic and clinical data associated with pulmonary embolism were collected along with the outcome. RESULTS: A total of nine patients of median age 16 years with the range from 12 to 20 received catheter-directed therapy for sub-massive (n = 6) and massive pulmonary embolism (n = 3). Among nine patients, one patient received Angiojet thrombectomy and balloon angioplasty, whereas eight patients received catheter-directed thrombolysis using tissue plasminogen activator through infusion catheters (n = 3) or EkoSonic ultrasound-accelerated thrombolysis system (n = 5). In four out of five patients treated with EkoSonic, significant clinical improvement was noticed within 24 hours. Among seven patients who survived, two patients had minor gastrointestinal bleeding with median hospital stay of 8 days with the range from 5 to 24 days, and two patients with massive pulmonary embolism died possibly due to delayed institution of catheter-directed therapy. CONCLUSION: Catheter-directed therapy with/without EkoSonic is an emerging alternative therapy for sub-massive and massive pulmonary embolism in children. A timely institution of catheter-directed therapy appeared important to improve the outcome.

Ultrasound-guided versus palpation-guided radial artery catheterization in adult population: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The radial artery (RA) is routinely used for both hemodynamic monitoring and for cardiac catheterization. Although cannulation of the RA is usually undertaken through manual palpation, ultrasound (US)-guided access has been advocated as a mean to increase cannulation success rates and to lower RA complications; however, the published data are mixed. We sought to evaluate the impact of US-guided RA access compared with palpation alone on first-pass success to access RA. METHODS AND RESULTS: Meta-analysis of 12 randomized controlled trials comparing US-guided with palpation-guided radial access in 2,432 adult participants was done. Hemodynamic monitoring was the most common reason for RA catheterization. Only 2 randomized controlled trials evaluated patients undergoing cardiac catheterization. Ultrasound-guided radial access was associated with increased first-attempt success rate (risk ratio [RR] 1.35, 95% CI 1.16-1.57]) and decreased failure rate (RR 0.52, 95% CI 0.32-0.87). There were no significant differences in the risk of hematoma (RR 0.43, 95% CI 0.27-1.06), the mean time to first successful attempt (mean difference 25.13 seconds, 95% CI -1.06 to 51.34) or to any successful attempt (mean difference -4.74 seconds; 95% CI -22.67 to 13.18) between both groups. CONCLUSIONS: Ultrasound-guided technique for RA access has higher first-attempt success and lower failure rate compared with palpation alone, with no significant differences in access site hematoma or time to a successful attempt. These findings support the routine use of US guidance for RA access.

Pre-close technique of percutaneous closure for delayed hemostasis of large-bore femoral sheaths.

Advancement of coronary interventions and portable hemodynamic device requires placement of large bore sheaths. Access for large caliber sheaths, its placement, maintenance, and hemostasis is very challenging and one of the key ailments for successful procedures. Traditional hemostasis method is manual compression, which is unattractive due to its own limitations and subsequent complications. Single closure device for sheath size larger than 8 French (Fr) is not available. We performed retrospective analysis of large cohort of patients with 13, 14 Fr sheaths (Impella device [ABIOMED]) percutaneous closure with the use of two Perclose devices. Two perclose devices were placed in a "Preclose" fashion and hemostasis was obtained few days later once hemodynamic support was weaned off by deployment of perclose sutures.

The impact of mitral stenosis on outcomes of aortic valve stenosis patient undergoing surgical aortic valve replacement or transcatheter aortic valve replacement.

BACKGROUND: The concomitant presence of mitral stenosis (MS) in the setting of symptomatic aortic stenosis represent a clinical challenge. Little is known regarding the outcome of mitral stenosis (MS) patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Therefore, we sought to study the outcome of MS patients undergoing aortic valve replacement (AVR). METHOD: Using weighted data from the National Inpatient Sample (NIS) database between 2011 and 2014, we identified patients who were diagnosed with MS. Patients who had undergone TAVR as a primary procedure were identified and compared to patients who had SAVR. Univariate and multivariate logistic regression analysis were performed for the outcomes of in-hospital mortality, length of stay (LOS), blood transfusion, postprocedural hemorrhage, vascular, cardiac and respiratory complications, permanent pacemaker placement (PPM), postprocedural stroke, acute kidney injury (AKI), and discharge to an outside facility. RESULTS: A total of 4524 patients were diagnosed with MS, of which 552 (12.2%) had TAVR and 3972 (87.8%) had SAVR. TAVR patients were older (79.9 vs 70.0) with more females (67.4% vs 60.0%) and African American patients (7.7% vs 7.1%) (P < 0.001). In addition, the TAVR group had more comorbidities compared to SAVR in term of coronary artery disease (CAD), congestive heart failure (CHF), chronic lung disease, hypertension (HTN), chronic kidney disease (CKD), and peripheral vascular disease (PVD) (P < 0.001 for all). Using Multivariate logistic regression, and after adjusting for potential risk factors, TAVR patients had lower in-hospital mortality (7.9% vs 8.1% adjusted Odds Ratio [aOR], 0.615; 95% confidence interval [CI], 0.392-0.964, P = 0.034), shorter LOS. Also, TAVR patients had lower rates of cardiac and respiratory complications, PPM, AKI, and discharge to an outside facility compared with the SAVR group. CONCLUSION: In patients with severe aortic stenosis and concomitant mitral stenosis, TAVR is a safe and attractive option for patients undergoing AVR with less complications compared with SAVR.

Mechanical circulatory support for acute right ventricular failure in the setting of pulmonary embolism.

BACKGROUND: Right ventricular (RV) failure due to pulmonary embolism (PE) increases morbidity and mortality and contributes to prolonged hospital length of stay and higher costs of care. RV mechanical circulatory support (MCS) including Impella RP devices have been increasingly used in hemodynamically compromised PE patients who are refractory to intravascular volume expansion and inotropic therapy. However, effectiveness and safety of Impella RP, in hemodynamically unstable PE patients is unknown. METHODS: We included consecutive patients who presented to Detroit Medical Center between November 3, 2015 and October 2, 2017 with acute PE and had evidence of hemodynamic compromise indicating Impella RP. RESULTS: Total of five cases were identified. All patients met the shock definition due to massive or submassive PE and therefore received Impella RP on admission. Cardiac index was improved from mean of 1.69/min/m2, (0.88-2.15 L/min/m2 ), to 2.5 L/min/m2 (range 1.88-3.4), after 24 h of treatment. Similarly, mean heart rate reduced to 92 beats per minute (79-105), and mean systolic blood pressure increased to 140 mmHg (115-179). No significant changes were found in renal function, hemoglobin and platelets level during device use. One patient experienced hemoglobin drop from 13.7 to 7.3 g/dL but did not require blood transfusion. All patients survived to discharge. CONCLUSION: In patients with PE and RV shock, Impella RP device resulted in immediate hemodynamic benefit with reversal of shock and favorable survival to discharge.

The impact of atrial fibrillation on transcatheter mitral valve repair outcomes: A propensity-matched analysis.

BACKGROUND: The concomitant presence of atrial fibrillation (AF) in the setting of Transcatheter Mitral Valve Repair (TMVR) represents a clinical challenge. Despite the high AF burden in patients presenting for the TMVR procedure, there are no studies that evaluate the impact of AF on in-hospital outcomes of TMVR in a nationally representative United States sample reflecting real practice. Therefore, we sought to study the outcomes of AF patients undergoing TMVR. METHODS AND RESULTS: The study included 1026 patients from the National Inpatient Sample (NIS) registry. Patients (age ≥18 years) who had undergone TAVR as a primary procedure from 2011 to 2014 were included, using the ICD-9-CM diagnostic codes. We examined patient characteristics and in-hospital outcomes. To account for patient and hospital-level baseline differences, we performed propensity score-matched analysis. The prevalence of AF was approximately 56%. After adjusting for patient-level and hospital-level characteristics, there was no statistical difference regarding in-hospital mortality (odds ratio [OR] 0.72, 95%CI 0.29-1.80, P = 0.487), post-TMVR complications, length of stay (OR 1.15, 95%CI 0.97-1.38, P = 0.111), and cost of hospitalization (OR 1.04, 95%CI 0.94-1.14, P = 0.475) between the group with AF versus without AF. However, patients with AF were more likely to have non-routine hospital discharge (42.94% vs 35.48% P = 0.02). CONCLUSION: AF is a frequently encountered arrhythmia among patients undergoing TMVR with MitraClip. However, TMVR can be performed safely in the vast majority of patients, irrespective of their baseline rhythm.