The Single-Access Technique for Impella Protected Percutaneous Coronary Intervention: A Single-Center Experience

Background. In this era of complex high-risk percutaneous coronary intervention (HR-PCI), mechanical support is being increasingly used. Traditionally, mechanical circulatory support with the Impella CP device requires a large-bore arterial access and an additional arterial access for the subsequent coronary intervention. We present a case series of the novel single‐access for HR-PCI (SHIP) technique, in which a single arterial access is used for both mechanical support and coronary intervention. We reviewed 35 patients from June 2019 to February 2021 in whom the procedure was successfully employed in all but 1 case. In our case series, this technique appeared to be safe and feasible, and none of our patients suffered any major bleeding or vascular complications. As our experience with the procedure grew, we started employing this technique in patients presenting with ST-segment elevation myocardial infarction and cardiogenic shock. We discuss in detail the nuances of the technique, including troubleshooting, procedural characteristics, and complications, and review the currently available literature.

J INVASIVE CARDIOL 2022;34(3):E190-E195. Epub 2021 December 19.

Key words: high-risk percutaneous coronary interventions, protected PCI, SHIP technique

Impella-assisted high-risk percutaneous coronary intervention (HR-PCI) has been shown to be safe and effective, with a low rate of periprocedural complications.¹ The Impella CP (ICP) device (Abiomed) requires 14 Fr arterial access. Traditionally, Impella-assisted PCI requires dual arterial access sites, ie, a 14 Fr access for the Impella and a second arterial access for a coronary guide catheter to deliver balloons and stents. Intuitively, obtaining multiple vs single arterial access sites increases the risk for vascular complications and can prove challenging in this population, who can have a higher burden of peripheral vascular disease. Importantly, once the ICP pump is positioned in the ventricle, only the smaller 9 Fr catheter shaft remains in the ICP introducer sheath, peripheral vasculature, and aorta until the root. The size difference between the 14 Fr sheath and the 9 Fr catheter shaft can accommodate a second sheath (up to 7 Fr) within the introducer sheath (Figure 1).

Multiple case examples of the single‐access for HR-PCI (SHIP) technique were shared on social media in 2019. Furthermore, a small case series was recently published and showed reasonable outcomes and safety with the SHIP technique.² The United States Food and Drug Administration subsequently approved the ICP introducer sheath for use with the single-access technique.³ At our institution, we first employed the technique in early 2019, and it has been our standard of care in high-risk Impella-protected interventions since. We present our experience to date, a case series of 35 patients who underwent HR-PCI using the SHIP technique.

1. A large-bore 14 Fr Impella peel-away sheath is utilized for arterial access, which is universally obtained with ultrasound guidance, and the ICP device is positioned using the standard technique under fluoroscopic guidance. We then employ the preclose technique⁴ using Perclose ProGlide (Abbott) suture-mediated closure.

2. Once the device is appropriately positioned, a micropuncture needle is used to pierce through the Impella sheath membrane at the 10:00 or 2:00 position (Figure 2).

3. The sheath is dilated and exchanged for an Amplatz extra-stiff 0.035˝ wire (Cook Medical) over which a 45 cm long 7 Fr Destination sheath (Terumo) is placed for coronary procedures requiring additional support. In cases not requiring additional support, a 6 or 7 Fr Slender radial sheath (Terumo) can be directly advanced over the 0.018˝ micropuncture guidewire.

4. The coronary sheath is advanced under fluoroscopy to ensure that the Impella device position is fixed. This sheath-in-sheath method thereby provides a single arterial access for simultaneous mechanical support and PCI.

5. Upon completion of the case, the catheter is removed slowly, as rapid removal may damage the valve membrane, resulting in unabated arterial flow through the valve.

6. The Impella peel-away sheath membrane closes automatically around the smaller coronary access sheath and can be removed, and vascular closure is performed once the procedure is complete.

We reviewed 35 consecutive patients who underwent ICP-assisted HR-PCI at our institution from June 2019 to February 2021 in whom the single-access technique was performed. All data were collected retrospectively using our electronic health record and institutional PCI registry. Data collection was exempt from the requirements of the institutional review board.

As expected, all cases were complex HR-PCIs. Table 1 and Table 2, Part 1 and Part 2 summarize the baseline patient characteristics and procedural aspects, respectively. The average age of our patients was 68.7 ± 4.2 years and the average body mass index was 30.8 ± 2.5 kg/m². Twenty-six (73.6%) were men. Seven patients (20.5%) had documented peripheral vascular disease, and the average left ventricular ejection fraction was 38.4 ± 6.4%. Ultrasound and fluoroscopic guidance were used to obtain femoral arterial access (either right or left) in all patients, using a micropuncture needle. One patient required arterial crossover to the contralateral femoral artery due to an inability to pass the coronary sheath along the ICP catheter, as described below.

Among the 34 patients in whom single-access technique was successfully employed, 21 (61.7%) underwent multivessel PCI. Eighteen patients (52.9%) had a left main coronary intervention, 15 (44.1%) had a proximal left anterior descending coronary artery intervention, and 14 (41.7%) had a left circumflex intervention. Ten patients (29.4%) underwent rotational atherectomy. The mean procedural duration was 180 ± 34 minutes, mean fluoroscopic time was 49.7 ± 7.33 minutes, mean cumulative air kerma was 2635 ± 605 mGy, and average contrast volume was 279 ± 44 mL.

We observed no device deployment failures. The ICP was left in place after the procedure in 4 patients (11.7%) given ongoing cardiogenic shock. Perclose ProGlide suture-mediated closure was used to achieve access-site hemostasis in all cases in which the Impella was removed at the end of the case.

As our experience with the procedure grew, we employed this technique in 3 patients with acute ST-segment elevation myocardial infarction as a part of the National Cardiogenic Shock Initiative.⁵

Our analysis was specifically focused on any device-related and access-site complications that had occurred, in addition to procedure-related death. As previously mentioned, 1 patient required arterial crossover due to an inability to pass the coronary sheath alongside the Impella catheter due to the presence of severe calcification compressing the sheath at points of vessel tortuosity. Furthermore, 1 patient suffered a left ventricular perforation from the ICP device, which we discuss in greater detail below.

None of our patients suffered any minor or major bleeding. Given the heterogeneity in bleeding definitions used in acute coronary syndrome trials,⁶ for the purpose of our analysis, we elected to use the Thrombolysis in Myocardial Infarction criteria to define minor and major bleeding.^7,8 No patient suffered a vascular complication, which was defined as hematoma (requiring transfusion, associated with a 3 g/dL hemoglobin drop, or requiring intervention), loss of limb, surgical repair, acute thrombosis, retroperitoneal hematoma, femoral neuropathy, pseudoaneurysm, or arteriovenous fistula.^9,10

Four patients (11.7%) died within 30 days from non-procedure related causes and 1 died from the complications related to the left ventricular perforation and subsequent surgical repair.

We present a single-center case series of 35 patients in whom we performed the recently described single-access technique² for both elective and urgent HR-PCI. While none of our patients experienced minor or major vascular or bleeding complications, 1 serious complication related to the technique, a left ventricular perforation, occurred. Additionally, 1 patient required crossover to an additional arterial access site due to severe tortuosity and calcification within the iliofemoral vascular tree despite amenable vessel diameters. Inadequate catheter length has been identified as a potential pitfall of the single-access technique due to an inability to advance the coronary sheath to the hub of the Impella sheath;¹¹ however, we did not encounter this phenomenon in our population. No coronary-intervention specific difficulty was observed in our cohort.

As our experience with this technique has evolved, so too has a more standardized approach to its implementation. As is always the emphasis with Impella-supported PCI, adequate assessment of the peripheral vasculature, ideally upfront, is essential to the safe subsequent delivery of the requisite 14 Fr sheath. As was evident in our cases requiring crossover from the single to traditional dual access, close attention must also be paid to tortuosity and calcification within the iliofemoral system. Computed tomography (CT)-derived cross-sectional diameters for the Impella sheath suitability alone may be insufficient to predict the success of this technique. Attention must also be paid to calcification and tortuosity on preprocedure CT studies, which we strongly advise obtaining prior to all attempts.

Despite the observational nature of our report, we have consistently noted interaction and friction between the longer coronary sheath and Impella catheter. We hypothesize that this interaction is what likely led to our patient suffering a left ventricular perforation. Consequently, we recommend extreme care when advancing longer coronary sheaths, maintaining continuous traction on the Impella catheter at all times, to avoid inadvertent advancement of the device. To minimize friction, we have since universally employed the use of an Amplatz extra-stiff wire for coronary sheath and guide advancement, as this seems to minimize interaction with the Impella. In addition, we now exclusively use the 6/7 Fr Slender radial sheath (Terumo) when additional support is not needed. Ensuring adequate Impella placement prior to coronary sheath and guide deployment is also an important step to minimize further Impella coronary sheath interaction.

To summarize, we report our center’s experience with the SHIP technique, which utilizes a single arterial access for simultaneous mechanical support and coronary intervention. The technique does not require additional specific equipment and can be rapidly deployed in existing centers with experience in Impella-assisted coronary interventions. The authors recommend careful adoption of this technique given the ease of access, preservation of an alternate arterial access if required in the future, and likely reduced risk of access-site complications. The major limitations of the technique include a limit on the coronary sheath size (maximum of 7 Fr sheath or 8 Fr sheathless guide catheter) that can be used, the possibility of requiring a longer, non-standard coronary guide catheter in tall patients or those with tortuous vascular anatomy, bleeding from the Impella sheath (which may arise when the needle is pierced very close to the Impella catheter shaft), and interaction leading to movement of the Impella while advancing the sheath. While preliminary experience and studies are encouraging, prospective trials are needed to elucidate the true clinical benefits and safety of this technique.

In our case series, we noted no access-site complications or device malfunction related to the SHIP technique. This potentially has significant ramifications for Impella-assisted HR-PCIs, as it obviates the need for an additional arterial access, which intuitively reduces access-site complications. However, caution and nuance are required to limit failure and potentially life-threatening complications with the technique.

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