Introduction

Percutaneous coronary revascularization (PCI) in patients with complex anatomy and significant comorbidities is an increasing clinical challenge, especially considering the aging population and the rise of ischemic heart failure. The term “high-risk angioplasty” does not have a single definition, but it commonly refers to procedures in patients with a combination of the following: complex coronary anatomy (such as left main disease, multivessel disease, severe calcification), left ventricular dysfunction (LVEF < 35%), unstable clinical status (including cardiogenic shock), or significant comorbidities (advanced age, chronic kidney disease, etc.).

According to international multicenter registries such as that of the British Cardiovascular Intervention Society (BCIS) and the US National Cardiovascular Data Registry (NCDR), between 10% and 20% of all angioplasties conducted can be considered high risk, although this figure varies depending on applied criteria. In an NCDR CathPCI study that analyzed over 400,000 procedures, approximately 15% of patients met criteria for high clinical or hemodynamic risk1.

The mortality associated with these procedures is high. In patients with post-AMI cardiogenic shock, in-hospital mortality can exceed 40-50%, and in those with severely reduced LVEF, it can be around 10-15% even without shock2. The use of mechanical ventricular assist devices has been explored as a strategy to hemodynamically stabilize patients during an intervention, but evidence is still limited and there is much debate around its benefits.

Regarding data in Argentina, there are not many open registries that specifically document the incidence of high-risk angioplasties. However, according to data from the RENAC (National Registry of Coronary Angioplasties of the Argentine Society of Cardiology), around 8-12% of procedures correspond to patients with LVEF below 40%, and 20% are performed in subjects over 75 years old, two common factors in high-risk profiles3. Nevertheless, the availability of advanced hemodynamic support such as Impella or ECMO is limited in this territory, which has fostered interest in more accessible alternatives like the iVAC2L® (PulseCath B.V., Amsterdam, the Netherlands), both for technical, cost, and complexity reasons, which could highlight the actual availability of this method in our country.

Clinical case

A female patient with a history of hypertension initially presents with an episode of oppressive epigastric pain classified as functional class IV, reporting shorter duration pain in prior days. An ECG is performed, revealing sinus rhythm at 100 bpm, a qS pattern with ST-segment elevation of 4 mm in leads V1 to V3, and negative T-waves from V4 to V6, consistent with extensive anterior acute myocardial infarction (AMI). She is clinically classified as Killip-Kimball II upon admission (blood pressure [BP] 110/80 mmHg, heart rate [HR] 110 bpm).

She is transferred as an emergency to the Department of Hemodynamics, where she undergoes coronary angiography. Findings include a thin caliber left anterior descending artery (LAD) with subtotal obstruction in the proximal and mid segments, with probable intraluminal thrombus. The circumflex artery is dominant with severe lesions in the lateral and posterior ventricular branches. The right coronary artery is hypoplastic. Primary PCI is performed on the LAD, requiring inotropic support during the procedure. Balloon predilation is followed by the successful implantation of two drug-eluting stents: first, a distal stent measuring 2.5×24 mm and, second, a proximal stent measuring 2.75×28 mm. Final flow is classified as TIMI III.

Admission laboratory tests showed leukocytosis (white blood cell count [WBC]: 18,000; 80% neutrophils), creatine phosphokinase (CPK) 800, creatine kinase-MB (CK-MB) 71, troponin 7.8, lactate dehydrogenase (LDH) 414. Renal function was preserved.

Color Doppler transthoracic echocardiogram showed a 27-% left ventricular ejection fraction (LVEF), with severe anteroseptal and apical hypokinesia, mild mitral regurgitation, mild aortic regurgitation, and moderate tricuspid regurgitation, with an estimated pulmonary systolic pressure of 87 mmHg, compatible with severe pulmonary hypertension. The left atrium was normal in size, and the right-sided chambers showed no dilation or systolic dysfunction.

The patient progressed well from a coronary standpoint, but she developed low cardiac output in the Coronary Care Unit (CCU), requiring inotropic support (dopamine + dobutamine) and diuretics. For this reason, a decision was made to conduct complete revascularization as soon as possible. Taking into account this clinical scenario and the patient’s high clinical risk, operators decided to use ventricular assist devices during angioplasty.

Mechanical circulatory support (MCS) can be pulsatile—such as in the case of the IABP—, which is widely available but has limited clinical benefit, or continuous, which are more effective—especially the Impella—but with considerably higher cost. The iVAC2L MCS device is pulsatile and uses the same console as the IABP, which facilitates implementation4.

The patient was admitted to the cath lab, where subtotal obstructions were found in the posteroventricular branch, associated with subtotal obstruction of a large lateral ventricular branch. An 18-Fr arterial introducer sheath was placed through left femoral access, after which the assist device was advanced into the left ventricle and aorta; the device was programmed from the console and ventricular assistance was initiated. The patient began PCI with a BP of 90/50 mmHg. After starting the assistance, BP increased to 150/90 mmHg. The circumflex artery was predilated with a balloon and the first drug-eluting stent (2.5×16 mm) was successfully implanted in the branch. Finally, a second drug-eluting stent (2.75×12 mm) was implanted without complications.

Discussion

In this patient, the clinical scenario was complex due to a poor hemodynamic evolution, depressed ejection fraction, complex coronary anatomy, and a need for complete revascularization in order to improve patient hemodynamics. For these reasons, based on the literature review and expert consensus, the use of ventricular assist devices during the intervention emerged as a possible strategy, with the aim of providing better support and improving patient tolerance to this procedure, which is often complex and prolonged, and also associated with high mortality rates4-7.

The main theoretical foundations supporting this therapeutic decision are based on the management guidelines for patients with acute coronary syndromes with cardiogenic shock and multivessel disease, as described in the 2025 ACC/AHA/ACEP/NAEMSP/SCAI guidelines, which recommend the treatment of non-culprit vessels in cases of persistent shock, and also consider as reasonable the use of mechanical circulatory support devices in selected patients with refractory cardiogenic shock in a setting of an acute coronary syndrome (Class IIa recommendation, Level of Evidence B-R)⁸.

These were the reasons for selecting, among the available options, the iVAC2L system, as it is one of the most efficient devices, substantially increasing cardiac output during the procedure—even though this is not routinely quantified—and helping maintain stable systolic blood pressure with reduced need for inotropic agents4-5, 7.

This device is one of the easiest to use and its placement is fast: unlike arterial/venous or biventricular systems, it only requires the introduction of a catheter into the left ventricle, with support dependent on the intra-aortic balloon pump console, which is simple to operate6-7.

It provides a satisfactory level of circulatory support that allows the operator to perform revascularization with greater stability and safety. In addition, it can be implanted and removed directly in the cath lab without the need for vascular surgery, since the access site can be easily closed with a percutaneous device such as PROGLIDE® (Abbott Vascular, Santa Clara, CA, USA)6-7.

Another relevant aspect is the low incidence of device-related complications, particularly hemorrhagic or major complications, compared to other systems such as ECMO or Impella4-5, 7.

Finally, the lower economic cost of the iVAC2L compared to other mechanical assist devices reinforces its potential applicability in resource-limited centers⁶.

Conclusion

In this complex PCI, pulsatile left ventricular assist device iVAC2L proved to be a highly useful support method for our fragile patient, with accessible implantation, no complex management required, and no need for a vascular surgery team for device removal.

1. Kwok CS, Kontopantelis E, Myint PK, Shoaib A, Nolan J, de Belder MA, et al. Percutaneous coronary intervention in high-risk patients: an analysis from the British Cardiovascular Intervention Society database. Int J Cardiol. 2017;248:42-7. doi:10.1016/j.ijcard.2017.05.013

2. Thiele H, Akin I, Sandri M, de Waha-Thiele S, Meyer-Saraei R, Nordbeck P, et al. Short- and long-term outcomes of mechanical circulatory support in cardiogenic shock: a registry analysis. Eur Heart J Acute Cardiovasc Care. 2020;9(6):646-56. doi:10.1177/2048872620904094

3. Sociedad Argentina de Cardiología. Registro Nacional de Angioplastias Coronarias (RENAC). Informe 2021 [Internet]. Buenos Aires: SAC; 2021 [citado 2025 Sep 20]. Disponible en: 

4. Bulum J, Galic E, Lozic B, Krznaric M, Vukovic I, Skrlec I, et al. Pulsatile left ventricular assistance in high-risk percutaneous coronary interventions: short-term outcomes. J Clin Med. 2024;13(18):5357. doi:10.3390/jcm13185357

5. Uren NG, Price S, De Backer O, Ihdayhid AR, Shah P, Ooms J, et al. Joint EAPCI/ACVC expert consensus document on percutaneous ventricular assist devices. EuroIntervention. 2021;17(2):e130-45. doi:10.4244/EIJY21M05_01.

6. Basir MB, Schreiber TL, Grines CL, O’Neill WW. Effect of next-generation pulsatile mechanical circulatory support on cardiac mechanics: The PULSE Trial. Cardiovasc Revasc Med. 2022 Sep;42:133–142. doi:10.1016/j.carrev.2022.03.013

7. Sauren LD, Accord RE, Hamzeh K, Hamzeh N, Timmers L, van der Nagel T, et al. Asistencia circulatoria pulsátil iVAC 2L en intervenciones coronarias percutáneas de alto riesgo. EuroIntervention. 2017 Feb 20;12(15):e1836–e1843. doi:10.4244/EIJ-D-16-00371.

8. Rao SV, O’Donoghue ML, Ruel M, Rab T, Tamis-Holland JE, Alexander JH, et al. 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Apr;151(13):e771-e862. 

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Complex coronary angioplasty using the iVAC2L ventricular assist device in a patient with low ejection fraction

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