Clinical Outcomes of the Post-Closure Technique for Arteriotomy Closure With the Impella Cardiac Power Percutaneous Left Ventricular Assist Device

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J INVASIVE CARDIOL 2024. doi:10.25270/jic/24.00168. Epub August 26, 2024.

With the increasing utilization of endovascular mechanical circulatory support devices, such as the Impella CP (Abiomed), there is a need for standardized guidelines for its safe removal. Development of the Perclose post-closure technique was facilitated by the introduction of a new Impella repositioning sheath in 2019, which enabled re-access to the sidearm and stylet, rewiring of the access artery, and Impella sheath removal. Our retrospective single-center study included all patients undergoing Perclose post-closure technique for vascular access closure after Impella removal between 2018 and 2024. Forty-six patients, with a mean age of 63.8 years, predominantly male (82.6%), were included in the analysis. Indications for Impella placement included complex percutaneous coronary intervention (34.8%) and cardiogenic shock (CS) (heart failure-CS: 32.6%, myocardial infarction-CS: 21.7%). Clinically relevant complications were encountered in less than 5% of cases. No instances of covered stent placement, fasciotomy, amputation, or access site infections were reported. Our study underscores the safety of the Perclose post-closure technique following Impella removal in a diverse cohort of patients, with an overall clinically significant complication rate of less than 5%. The Perclose post-closure technique is a reliable and well-tolerated method for vascular access closure in patients undergoing Impella support.

Endovascular mechanical circulatory support (MCS) usage is rapidly increasing, leading to heightened awareness of vascular complications, including bleeding, vascular injury, and limb ischemia during device insertion and removal.¹ Despite the increasing use of MCS devices, standardized guidelines for their safe removal are lacking. Current practices vary widely across institutions and among operators, ranging from manual compression to the use of vascular closure devices like the Perclose (Abbott). One major challenge in determining optimal removal methods for MCS devices like the Impella (Abiomed) has been the inability to re-wire the access sheath for closure, despite previous attempts to address this issue.² Abiomed's introduction of a new Impella repositioning sheath in 2019 enabled re-access to the sidearm and stylet, facilitating rewiring of the access artery and Impella sheath removal. Operators used this opportunity to develop the post-closure technique,^3,4 yet there remains limited outcome data available.

At our institution, we employ the post-closure technique in patients supported by an Impella CP with side-arm access for rewiring who have an angiogram at the time of implant or removal conforming common femoral access and a clinical referral for Impella removal. We avoid this technique in patients with severe vascular calcification, poor arterial access, known dissection or thrombus in the femoral artery, or when there is a clinical referral for surgical closure or manual compression. Here, we share our institutional experience with the Perclose post-closure technique for vascular access closure after Impella removal.

We conducted a retrospective single-center study, which encompassed all patients for whom the Perclose post-closure technique was used for vascular access closure after Impella removal from 2018 to 2024. Briefly, the post-closure technique consists of the following steps (Figure A):

1. Access the sidearm of the Impella CP with a 0.035-inch wire and remove the Impella.
2. Place a 14-French (Fr) sheath (± 7-Fr sheath for hemostasis) and two 0.035-inch wires.
3. Use a 7-Fr dilator on 1 wire and deploy a Perclose on the other wire.
4. Deploy the second Perclose on the remaining wire and assess the need for any additional Perclose.

Data were collected from electronic medical records and independently extracted by 2 reviewers. Continuous data were summarized using means and standard deviations, while categorical data were presented as percentages. The study was approved by the Institutional Review Board (STUDY00005214), and informed consent was waived due to its retrospective design.

Out of a total of 62 Impella CP removals, 46 (74.2%) were performed using the post-closure technique, 10 (16%) with the pre-closure technique, 4 (6.4%) using primary surgical closure, and 2 (3.2%) with manual compression. The patients who underwent arteriotomy closure using the post-closure technique had a mean age of 63.8 years and were predominantly male (82.6%) (Table). Common comorbidities were coronary artery disease (63%), hypertension (47.8%), hyperlipidemia (32.6%), and diabetes (17.3%). Mean hemoglobin levels declined from 10.3 g/dL pre-Impella removal to 9.45 g/dL post-removal (P = .08). The majority were on antiplatelet therapy, with 6.8% of patients receiving a single antiplatelet agent and 61.3% receiving dual therapy (aspirin and clopidogrel in 36.3 %; aspirin and ticagrelor in 25%). All Impella CP insertions at our institution utilized ultrasonic guidance. Patients were on anticoagulation prior to Impella removal in 97.7% of cases, primarily heparin (93.2%). Indications for Impella placement included complex percutaneous coronary intervention (34.8%) and cardiogenic shock (CS) (heart failure [HF]-CS: 32.6%, myocardial infarction [MI]-CS 21.7%), and 11% of the patients were part of the STEMI-DTU pivotal trial. Impella was used with VA ECMO (ECPella) in 24% of the patients. Support duration varied, with 37% receiving it for 1 to 3 days, 20% for less than 1 day, and 11% for over 7 days. Approximately 45.6% of patients were transferred from another hospital, with a mean support duration prior to transfer of 1.5 days. Perclose alone was most used for vascular closure cases (84.7%), followed by Perclose with Angioseal (15.2%).

The mean follow-up duration was 21.1 days (SD 24.8). Less than 5% of the patients encountered clinically relevant complications, notably bleeding (4.3%), and surgical (2.2%) or non-surgical (2.2%) vascular intervention (Figure B). The Perclose device failed in 3 patients (6.5%): failure to capture requiring Impella removal by manual compression occurred in one patient, self-expanding stent placement for a flow-limiting dissection occurred in another patient, and surgical cutdown and repair due to the Perclose device getting embedded in a partially deployed suture occurred in the third patient. No cases of covered stent placement, fasciotomy, amputation, or access site infections were reported. All-cause mortality rate was 2.2%, with no deaths attributed to vascular access complications. Rehospitalization rate was 6.5%, unrelated to access complications, and no late complications were observed during the follow-up period.

We report our data on the clinical utility of the post-closure technique for Impella CP removal, revealing a clinically relevant complication rate of less than 5%. One of the concerns associated with the Impella MCS platform is vascular access-related bleeding complications and limb ischemia, which have seen a reduction in rates with advancements in Impella design, increased familiarity with the device, and enhancements in vascular access devices and closure techniques.^3,5 Our cohort includes patients who utilized the Impella CP for complex PCI, ECPella, and HF- and MI-CS, with over half of the patients on antiplatelet therapy and almost 90% on anticoagulation, rendering our findings applicable across a diverse spectrum of clinical scenarios. Prior reports have established a vascular complication rate ranging between 8% and 17% for percutaneously deployed Impella MCS devices (2.5 and CP).^6,7

We have previously reported our initial experience with the Perclose post-closure technique, which demonstrated significantly lower rates of adverse vascular events with the post-closure technique compared with manual compression (0% vs 40%; P = .01).³  Subsequently, we adopted the Perclose post-closure technique as the preferred method for closure after Impella removal at our institution, and similar results have been replicated elsewhere. Choi et al reported a 100% technical success rate using the post-closure technique for closure of 12- to 16-Fr large bore sheaths.⁸ A recent study involving 15 patients weaned from Impella 2.5, CP, or CP Smart Assist devices between April 2019 and April 2022 utilizing the post-closure technique for hemostasis reported an overall complication rate of 6.7%.⁹

In our study, 2 patients experienced clinically significant complications. In 1 patient, the second Perclose failed and there was a flow-limiting dissection of the right external iliac artery, which was successfully treated with a self-expanding stent. In another patient, the Perclose device became embedded in a partially deployed suture, leading to bleeding that required packed red cell transfusion and surgical intervention. Notably, these complications were attributed to the Perclose suture rather than the Impella pump. There were no occurrences of new hematoma formation, pseudoaneurysm, arteriovenous fistula, closure site infection, fasciotomy, amputation, or deaths related to closure site complications or limb ischemia. The overall complication rate in the group was 6.5%, with less than 5% that were clinically significant.

While bedside manual compression can be used for hemostasis, it is associated with higher complication rates and requires more operator time. The pre-closure technique is effective but may not be feasible in unstable patients for whom emergent pump insertion is needed or in situations where prolonged suture retention is anticipated. Reported complication rates with the pre-closure technique range from 1% to 6.8%.^10,11 Although direct comparison data is lacking, outcomes with the post-closure technique are likely comparable to those of the pre-closure technique, with additional benefits. Alternative closure methods like FemoStop, CompressAR, MANTA, PerQseal, and InSeal have varying complication rates, with the MANTA device showing a higher rate compared with our experience with the post-closure technique.¹² Despite the availability of these alternatives, post-closure offers a rapid and familiar approach with low complication rates, especially in emergent situations or when prolonged support is needed. Standardized closure protocols, including best-practice guidance for pump removal, could potentially reduce complication rates and improve outcomes with the expanding use of Impella pumps.

Limitations

This single-center analysis is limited by its retrospective design and the absence of a control arm. The closure technique was left to the operator's discretion, making it difficult to control for selection bias, which may have influenced our results. Prospective studies with larger sample sizes and control groups are needed to comprehensively evaluate the safety profile and long-term outcomes of the Perclose post-closure technique following Impella removal.

Our retrospective single-center study underscores the safety of the Perclose post-closure technique following Impella removal in a diverse cohort of patients, with an overall clinically significant complication rate of less than 5%. The Perclose post-closure technique is a reliable and well-tolerated method for vascular access closure in patients undergoing Impella support.

Kevin J. John, MD; Haval Chweich, MD; Carey Kimmelstiel, MD; Charles D. Resor, MD; Navin K. Kapur, MD

From The CardioVascular Center, Tufts Medical Center, Boston, Massachusetts, USA.

Disclosures: Dr. Resor has received consulting fees from Medtronic and paid travel and other expenses from Edwards Lifesciences. Dr. Kapur has received consulting honoraria and institutional grant support from Abbott Laboratories, Abiomed Inc, Boston Scientific, Medtronic, LivaNova, Getinge, and Zoll. The remaining authors report no financial relationships or conflicts of interest regarding the content herein.

Address for correspondence: Navin K. Kapur, MD, Tufts Medical Center, 800 Washington Street, Box # 80 Boston, MA 02111, USA. Email: Nkapur@tuftsmedicalcenter.org; X: @navinkapur4