A Novel Technique for Impella Removal From Non-Preclosed Arteries Using Perclose ProGlide Closure Device

According to the American Heart Association’s Heart Disease and Stroke Statistics – 2017 Update, heart failure is present in 6.5 million patients in the U.S. and is expected to rise another 46% by 2030.¹ A recent data analysis from the Nationwide Inpatient Sample from 2004 to 2014 also shows that discharges complicated by cardiogenic shock increased by 2-fold and 48% of patients with cardiogenic shock in 2014 did not survive to discharge.²  

The Impella (Abiomed) is a continuous, nonpulsatile, axial flow Archimedes-screw pump that reduces the work of the left ventricle and provides active hemodynamic support by propelling aspirated blood from the left ventricle into the ascending aorta. The FDA had approved the Impella (2.5 and CP) for short-term use for the treatment of ongoing cardiogenic shock that occurs immediately (<48 hours) following acute myocardial infarction (AMI) or open heart surgery, and is not responsive to optimal medical management and conventional treatment measures, including volume loading and the use of pressors and inotropes, with or without use of an intra-aortic balloon pump.

Recently, the FDA approved a second indication for the Impella 2.5 and Impella CP for use during high-risk percutaneous coronary intervention (PCI) with the presence of severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined the Impella to be an appropriate therapeutic option.³ In such patients, the Impella may prevent hemodynamic instability associated with repeat episodes of reversible myocardial ischemia from planned temporary coronary occlusions (ballooning and stenting) and may reduce peri- and post-procedural adverse events. Given the growth of high-risk PCI and increase in the incidence of heart failure and cardiogenic shock,⁴ the utilization of the Impella is likely to increase exponentially.

Usually the Impella arterial access site (14 French) is preclosed with a Perclose ProGlide vascular closure device (Abbott Vascular). The problem lies in cases of emergency, if the access site is not preclosed, and/or if there is a failure of the preclosed access site. To provide extended hemodynamic support when indicated, the peel-away sheath is often removed to secure the Impella in place, leaving no way to regain arterial access for device closure. Subsequently, to achieve hemostasis after Impella removal, prolonged manual compression for up to 45 minutes is required, leading to excessive patient discomfort, risk of bleeding, inconvenience to staff, and extended bed rest for patients. Hence, we have devised a simple technique to overcome this problem. This technique entails a means to re-access the artery from the original access and close with a Perclose ProGlide device. Following are the steps with illustrations (videos are available with the article at cathlabdigest.com).

Technique to Regain Vascular Access 

Step 1. The patient is draped and the access site, contralateral groin and Impella driveline are all prepped in sterile fashion (Figure 1).

Step 2. The patient is weaned off the Impella, which is then disconnected from the console.

Step 3. The Impella is pulled back into the abdominal aorta (Figure 2, Video 1).

Step 4. A Cook needle is then inserted deep into the Impella driveline around the 45 cm mark and a table wire is advanced via the needle 3-5 cm into the driveline (just enough to anchor it in the driveline) (Figure 3).

Step 5. The needle is withdrawn over the wire and removed, leaving the wire anchored in the driveline (Figure 4).

Step 6. The Impella is pushed up into the ascending aorta along with the wire tip embedded in the Impella driveline to the 65-70 cm mark without re-crossing the aortic valve (Figure 5, Video 2).

Step 7. Under fluoroscopic guidance, the table wire is withdrawn while the Impella driveline is held in place, to free it from the Impella. The table wire is then advanced into the ascending aorta (Figure 6, Video 3).

Step 8. While keeping the wire in place, the Impella is removed. 

Step 9. Using the newly gained wire access into the femoral artery, Perclose ProGlide devices are deployed until hemostasis is achieved (Figure 7).

Results

Since 2013, we have successfully used this technique for nine Impella removals. The mean patient age was 55 ± 12 years, with 78% male. Fifty-six percent of patients had an acute coronary syndrome complicated by cardiogenic shock, and 44% had ventricular tachycardia-related arrest and VT storm leading to cardiogenic shock. Eight out of nine patients had multivessel coronary artery disease; one patient had non ischemic cardiomyopathy. The success rate for this procedure was 100% with no early or delayed failures. All patients tolerated the procedure well. 

Discussion

In 2015, the Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support (MCS) Devices acknowledged that percutaneous mechanical circulatory support devices provide hemodynamic support that is superior to pharmacologic therapy, and hence should be used appropriately in select patients with persistent cardiogenic shock despite appropriate revascularization and pharmacologic therapies.⁵ The Impella device has been utilized in over 50,000 patients in the United States alone.⁶ 

Consensus publications and clinical guidelines from the American College of Cardiology and Society for Cardiovascular Angiography and Interventions have documented the Impella as the new standard of care in algorithms to treat high-risk PCI. It is estimated that approximately 121,000 high-risk patients undergo PCI annually in the U.S. Given the growth of high-risk Impella-assisted PCI, and the increase in incidence of heart failure and cardiogenic shock, this utilization is likely to increase exponentially.⁴

One of the biggest concerns regarding Impella use is the ability to manage large-bore access and possibility of closure device failure. Our technique is a simple way to overcome these concerns and access the non preclosed large-bore arterial access, resulting in successful closure with a Perclose ProGlide device. This technique can also be used to re-access the arterial access site in already preclosed patients to ensure safe closure of the large-bore access in case of failure. There was some anticipation that after regaining access, the Perclose device may not ‘catch’ the arterial edges of the existing large-bore access, but we did not encounter any problems of this nature. 

Impella removal, when done in a separate session from insertion, is a reimbursable procedure with 6.15 RVUs (CPT Code 33992). With its ability to minimize discomfort by avoiding extended manual compression at the groin site and reduce patient bedrest duration, we believe this technique benefits both providers and patients. 

Conclusion 

Mechanical circulatory support is indicated for high-risk percutaneous intervention circulatory support and cardiogenic shock. A significant number of Impella insertions occur under urgent conditions without the time to preclose the 14 French access site. There are also cases where the Impella is left in situ for hemodynamic support and the peel-away sheath is removed, leaving no way to regain arterial access. If the access site is not preclosed or fails to achieve hemostasis, the only current method of achieving hemostasis is ≥45 minutes of manual compression of the femoral artery access site, with its attendant risk of blood loss and both patient and provider discomfort. Herein, we show a simple yet novel technique for Impella removal and the ability to achieve hemostasis using a common closure device.

References

1. Benjamin EJ, Blaha MJ, Chiuve SE, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics–2017 update: a report from the American Heart Association. Circulation. 2017 Mar 7;135(10): e146- e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. Erratum in: Circulation. 2017 Mar 7; 135(10 ): e646.
2. Mandawat A, Rao SV. Percutaneous mechanical circulatory support devices in cardiogenic shock. Circ Cardiovasc Interv. 2017 May;10(5). pii: e004337. doi: 10.1161/CIRCINTERVENTIONS.116.004337. 
3. Abiomed Impella CP receives expanded FDA approval for high-risk PCI procedures. Abiomed press release, Dec 7, 2016. Available online at https://investor.abiomed.com/releasedetail.cfm?releaseid=1003087. Accessed March 7, 2016.
4. Writing Group Members. Mozaffarian D, Benjamin EJ, Go AS, et al. American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart disease and stroke statistics-2016 update: a report from the American Heart Association. Circulation. 2016. January 26; 133(4): e38-e60. doi: 10.1161/CIR.0000000000000350
5. Rihal CS, Naidu SS, Givertz MM, et al. Society for Cardiovascular Angiography and Interventions (SCAI); Heart Failure Society of America (HFSA); Society of Thoracic Surgeons (STS); American Heart Association (AHA), and American College of Cardiology (ACC) 2015. SCAI/ACC/HFSA/STS clinical expert consensus statement on the use of percutaneous mechanical circulatory support devices in cardiovascular care: endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latinoamericana de Cardiología Intervencionista; affirmation of value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d’Intervention. J Am Coll Cardiol. 2015 May 19; 65(19): e7-e26. doi: 10.1016/j.jacc.2015.03.036. 
6. Abiomed Surpasses 50,000 Impella^® Patients Treated in the United States. Abiomed press release, Feb 23, 2017. Available online at https://investor.abiomed.com/releasedetail.cfm? releaseid=1014269. Accessed February 23, 2017.

Disclosure: Drs. Gurley, Wilson, and Marycz report no conflicts of interest regarding the content herein. Dr. Bhalla’s research time is funded by the NIH’s funded KL2 program at University of Kentucky’s The UK Center for Clinical and Translational Science (CCTS). 

The authors can be contacted via Dr. Vikas Bhalla at vikas.bhalla@uky.edu.