Feasibility and Safety of an 8 F Angioseal® Vascular Closure Device for Closure of Large Bore Impella CP® Access

2021 ◽  
pp. 152660282110479
Author(s):  
Christian F. Zachoval ◽  
Alexander Sedaghat ◽  
Mehmet Oezkur ◽  
Vedat Tiyerili ◽  
Marc U. Becher ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cardiogenic Shock ◽  
Normal Weight ◽  
Clinical Indication ◽  
Circulatory Support ◽  
Acute Ischemia ◽  
Closure Device ◽  
Vascular Closure Device ◽  
Access Port ◽  
Post Hoc

Purpose: Percutaneous mechanical circulatory support (pMCS) with the Impella® device is routinely used in cardiogenic shock and high risk percutaneous coronary interventions (PCI). However, safety and feasibility to close the large bore access (LBA) post-hoc remain a challenge. Materials and Methods: In patients with planned termination of Impella therapy, corresponding LBA closure was attempted using an undersized AngioSeal® device, which was deployed after insertion of a 0.035 in J-wire through the guidewire access port. Cross-over angiographic visualization before and after deployment as well as in-hospital follow up were performed to assess closure success and screening for short-term adverse events. Results: We evaluated 17 patients (68 year old, IQR 58–76, 71% male) in whom 14 F LBA closure after pMCS using the Impella CP® was achieved with an undersized AngioSeal® device. Clinical indication for pMCS was cardiogenic shock in 94% and protected PCI in 6%. Impella CP® devices were withdrawn after a median of 4 days (IQR 3–6 days). Primary hemostasis was achieved in the majority of patients (14/17; 82%) while single cross-over balloon inflation led to hemostasis in the remaining patients. One patient suffered acute ischemia later in the course of the disease, but this was not directly related to the closure device. In this study, no major bleeding or other device-related adverse events were observed. Conclusion: The 8 F AngioSeal® vascular closure device has been safely used for removal of the Impella CP® microaxial pump in most cases of predominantly normal weight patients. This technique may be considered feasible for post-hoc LBA closure in the context of pMCS, especially when preclosure options are not suitable or unavailable.

scholarly journals Cardiogenic Shock and Short-Term Mechanical Circulatory Support Options in the Current Era: Focus on Adverse Events

2018 ◽  
Vol 24 (8) ◽  
pp. S127
Author(s):  
Iosif Taleb ◽  
Antigone Koliopoulou ◽  
Anwar Tandar ◽  
Stephen McKellar ◽  
Jose Nativi-Nicolau ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cardiogenic Shock ◽  
Mechanical Circulatory Support ◽  
Circulatory Support ◽  
Short Term

Adverse Events and Modes of Failure Related to VASCADE Vascular Closure Device System: The Utility of the MAUDE Database

2021 ◽  
Vol 28 ◽  
pp. S16
Author(s):  
Brian C. Case ◽  
Sant Kumar ◽  
Giorgio A. Medranda ◽  
Charan Yerasi ◽  
Brian Forrestal ◽  
...  
Keyword(s):  
Adverse Events ◽  
Closure Device ◽  
Vascular Closure Device ◽  
Modes Of Failure

scholarly journals Multidisciplinary approach and early use of percutaneous mechanical circulatory support devices in patients with cardiogenic shock

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Venuti ◽  
M Gramegna ◽  
L Baldetti ◽  
F Calvo ◽  
V Pazzanese ◽  
...  
Keyword(s):  
Heart Failure ◽  
Mortality Rate ◽  
Adverse Events ◽  
Hospital Mortality ◽  
Cardiogenic Shock ◽  
Mechanical Circulatory Support ◽  
Multidisciplinary Approach ◽  
Circulatory Support ◽  
Coronary Syndrome ◽  
Early Use

Abstract Background Despite progresses in the reperfusion strategies, the prognosis of patients with cardiogenic shock (CS) remains poor with a high in-hospital mortality rate. Percutaneous mechanical circulatory support systems (pMCS) reducing afterload, preload and myocardial oxygen demand, preventing compensatory tachycardia and increasing mean arterial pressure, lead to improve end-organ perfusion. Since CS progression to a refractory shock state is deleterious, timing of treatment represents a crucial issue in these patients. Purpose The aim of our study was to assess whether a multidisciplinary approach and an early use of pMCS could be safe and effective in improving CS patients' outcome. Methods We examined the outcome in terms of one-month survival of 62 patients (75.8% males, mean age 67.7±12.2 years) admitted between January and December 2018 to our Cardiac Intensive Care Unit (CICU) with cardiogenic shock due to acute coronary syndrome (ACS), acute heart failure (AHF) and other causes in 43.5%, 21.6%, 35.4% of cases respectively. For each patient, a Multidisciplinary Shock Team (CS-Team) including critical care specialists, interventional cardiologists and advanced heart failure specialists, was involved and the early use of pMCS was considered. Results Overall, 52 (83.9%) CS patients underwent pMCS implant, including intra-aortic ballon pump counterpulsation (IABP), Impella system (Impella), venous-arterial extracorporeal membrane oxygenation (VA ECMO) in 67.7%, 46.7%, 11.3% of cases respectively. Median time from the first CS-Team contact to the pMCS implantation was 32.5 (30–60) minutes. Among ACS-CS group, AHF-CS group and CS-due to other causes group, pMCS were implanted in 25 (92.5%), 12 (92.3%) and 15 (68.1%) patients respectively. Lower extremities ischemia, gastrointestinal/intracerebral and life-threatening bleeding and ischemic stroke were observed as pMCS related adverse events in 9.7%, 6.4%, 1.6%, 3.2%, 6.4% of cases respectively. At one month, 56 (90.3%) CS patients were discharged alive while 6 (9.7%) CS patients died during the CICU stay. Conclusion A multidisciplinary approach of CS patients, contemplating an early and extensive use of pMCS, may be effective in the reduction of in-hospital mortality rate with a low and acceptable occurrence of pMCS related adverse events. Funding Acknowledgement Type of funding source: None

Abstract 366: Risk of Adverse Events With Left Ventricular Assist Devicein Cardiogenic Shock Patients

Circulation ◽  
2019 ◽  
Vol 140 (Suppl_2) ◽  
Author(s):  
Clauden Louis
Keyword(s):  
Adverse Events ◽  
Cardiogenic Shock ◽  
Medical Center ◽  
Left Ventricular ◽  
Circulatory Support ◽  
Ventricular Assist ◽  
Perioperative Bleeding ◽  
Surgical Bleeding ◽  
Level 1 ◽  
The University

Study: The aim of this single-center, a retrospective study was to evaluate early and long-term adverse events in advanced heart failure patients with cardiogenic shock who underwent ventricular assist device (VAD) implantation. We hypothesize that outcomes in patients implanted with LVAD with INTERMACS 1 have increased the risk of perioperative bleeding and infection. Methods: We evaluated outcomes in 191 patients with a HeartMate II LVAD implanted between May 2008 and June 2014 at the University of Rochester Medical Center, enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) Registry. Patients were divided into two groups: A) INTERMACS level 1 (cardiogenic shock) or B) INTERMACS level>1 (noncardiogenic shock). Preoperative characteristics, as well as post-surgical bleeding, infection and all-cause mortality, were assessed. The original LVAD database has received exempt status from the RSRB (RSRB00043111). Results: From 191 patients, there were 59 patients with INTERMACS level 1, and 132 with INTERMACS level greater than 1. Patients with INTERMACS level 1 at LVAD implantation were younger. Following LVAD implantation, INTERMACS level 1 patients had a trend towards bleeding and infection.

Comparative Effectiveness and Safety Between Milrinone or Dobutamine as Initial Inotrope Therapy in Cardiogenic Shock

2018 ◽  
Vol 24 (2) ◽  
pp. 130-138 ◽  
Author(s):  
Tyler C. Lewis ◽  
Caitlin Aberle ◽  
Diana Altshuler ◽  
Greta L. Piper ◽  
John Papadopoulos
Keyword(s):  
Adverse Events ◽  
Cardiogenic Shock ◽  
Mechanical Circulatory Support ◽  
Circulatory Support ◽  
Limited Data ◽  
Similar Extent ◽  
Hemodynamic Changes ◽  
Initial Management ◽  
P 75 ◽  
Vasoactive Medications

Inotropes are an integral component of the early stabilization of the patient presenting with cardiogenic shock. Despite years of clinical experience with the 2 most commonly used inotropes, dobutamine and milrinone, there remains limited data comparing outcomes between the two. We conducted a retrospective review to compare the effectiveness and safety of milrinone or dobutamine for the initial management of cardiogenic shock. Adult patients with cardiogenic shock regardless of etiology who received initial inotrope therapy with either milrinone (n = 50) or dobutamine (n = 50) and did not receive mechanical circulatory support were included. The primary end point was the time to resolution of cardiogenic shock. Changes in hemodynamic parameters from baseline and adverse events were also assessed. Resolution of shock was achieved in similar numbers in both the groups (milrinone 76% vs dobutamine 70%, P = .50). The median time to resolution of shock was 24 hours in both groups ( P = .75). There were no differences in hemodynamic changes during inotrope therapy, although dobutamine trended toward a greater increase in cardiac index. Arrhythmias were more common in patients treated with dobutamine than milrinone, respectively (62.9% vs 32.8%, P < .01), whereas hypotension occurred to a similar extent in both groups (milrinone 49.2% vs dobutamine 40.3%, P = .32). The use of concomitant vasoactive medications, dosage required, and duration of therapy did not differ between groups. There was no difference in the overall rate of discontinuation due to adverse event; however, milrinone was more commonly discontinued due to hypotension (13.1% vs 0%, P < .01) and dobutamine was more commonly discontinued due to arrhythmia (0% vs 11.3%, P < .01). Milrinone and dobutamine demonstrated similar effectiveness and safety profiles but with differences in adverse events. The choice of milrinone or dobutamine as initial inotrope therapy for cardiogenic shock may depend more on tolerability of adverse events.

scholarly journals The application of a vascular closure device for closing a gastrostomy opening used for procedural access

2019 ◽  
Vol 92 (1099) ◽  
pp. 20180837
Author(s):  
Sung Bum Cho ◽  
Hyoung Rae Kim ◽  
Eui-Chul Jung ◽  
Hwan Hoon Chung ◽  
Seung Hwa Lee ◽  
...  
Keyword(s):  
In Vitro Study ◽  
Closure Device ◽  
Leak Pressure ◽  
Vascular Closure Device ◽  
Significant Difference ◽  
Manual Suture ◽  
Survival Studies ◽  
Post Hoc ◽  
Experimental Group

Objective: To study the feasibility of applying the Perclose ProGlide vascular closure device (PPVCD) in vitro for closing a gastrostomy opening for procedural access in the swine stomach in order to prevent peritoneal leakage. Methods: The study included four experimental groups: one manual suture (n = 10), two manual sutures (n = 10), one PPVCD suture (n = 10), and two PPVCD sutures (n = 5). In the two PPVCD sutures group, the “pre-close” technique was used. The leak pressure was measured, and statistical analysis was conducted to compare the leak pressures among the experimental groups. Results: The gastrostomy openings were successfully closed in all experimental groups. The median (range) values of leak pressure (mmHg) for each experimental group were as follows: one manual suture, 86.0 (75.0–110.0); two manual sutures, 98.5 (44.0–130.0); one PPVCD suture, 96.5 (56.0–119.0); and two PPVCD sutures, 98.0 (66.0–104.0). The Mann–Whitney U test revealed no statistically significant difference in leak pressure between the manual (n = 20) and PPVCD (n = 15) suture groups. The Kruskal–Wallis test revealed no statistically significant difference in leak pressure among the four experimental groups. The Bonferroni post hoc test also revealed no statistically significant difference in the pairwise comparisons among the groups. Conclusion: Application of PPVCD is feasible for the closure of gastrostomy openings in an animal model and is as effective as a manual suture. Advances in knowledge: In our in vitro study, percutaneous closure of gastrostomy opening using PPVCD was possible; animal survival studies and development of specific devices are needed before clinical application.

Symptomatic vascular complications after vascular closure device use following diagnostic and interventional catheterisation

VASA ◽  
2004 ◽  
Vol 33 (2) ◽  
pp. 78-81 ◽  
Author(s):  
Thalhammer ◽  
Aschwanden ◽  
Jeanneret ◽  
Labs ◽  
Jäger
Keyword(s):  
Current Literature ◽  
Vascular Complications ◽  
University Hospital ◽  
Closure Device ◽  
Ultrasound Guided ◽  
Vascular Closure Device ◽  
Device Use ◽  
Arterial Stenoses ◽  
The University ◽  
Stenotic Lesions

Background: Haemostatic puncture closure devices for rapid and effective hemostasis after arterial catheterisation are a comfortable alternative to manual compression. Implanting a collagen plug against the vessel wall may become responsible for other kind of vascular injuries i.e. thrombotic or stenotic lesions and peripheral embolisation. The aim of this paper is to report our clinically relevant vascular complications after Angio-Seal® and to discuss the results in the light of the current literature. Patients and methods: We report the symptomatic vascular complications in 17 of 7376 patients undergoing diagnostic or therapeutic catheterisation between May 2000 and March 2003 at the University Hospital Basel. Results: Most patients presented with ischaemic symptoms, arterial stenoses or occlusions and thrombotic lesions (n = 14), whereas pseudoaneurysms were extremely rare (n = 3). Most patients with ischaemic lesions underwent vascular surgery and all patients with a pseudoaneurysm were successfully treated by ultrasound-guided compression. Conclusions: Severe vascular complications after Angio-Seal® are rare, consistent with the current literature. There may be a shift from pseudoaneurysms to ischaemic lesions.

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