Percutaneous coronary intervention (PCI) is the most commonly performed revascularization method, even in cases of high anatomical complexity, particularly in patients at high surgical risk.^1,2 However, with the increase in anatomical complexity, associated with population aging and the increased incidence of comorbidities, an increase in the risk profile of PCIs is observed.^3–5

In this context, mechanical circulatory assistance devices (MCAD) are known to promote improvements in hemodynamic parameters^6.7 and are recommended for temporary mechanical circulatory support in the high-risk PCI context.^8–11

The iVAC 2L device (Pulsecath BV, Amsterdam, The Netherlands) is a retrograde insertion MCAD via the femoral artery. The device consists of a bidirectional valve connected to an extracorporeal membrane by a 17Fr cannula. Blood is aspirated from the ventricle through the catheter tip during systole to the membrane, and during diastole, the membrane ejects blood into the ascending aorta through the bidirectional valve (Figure 1). The membrane is moved by mobilizing helium gas through the intra-aortic balloon console (Video 1), which controls the device's operation. The catheter tip is positioned retrogradely below the aortic valve and into the left ventricle (Figure 1). Under ideal conditions (heart rate 70-80 bpm), the additional cardiac output is up to 2.0 L/min, with pulsatile flow. The safety and function of the iVAC 2L have been previously reported.^12,13

We will present the first case in Brazil of complex high-risk PCI performed with the support of the iVAC 2L device.

We report the case of an 81-year-old man with hypertension and diabetes, referred to our service with dyspnea and class III angina. A functional evaluation with scintigraphy was performed, which demonstrated ischemia in the anterior and anteroseptal walls, in addition to a drop in blood pressure at peak exercise and a left ventricular ejection fraction of 34%. Cardiac catheterization was then indicated, which revealed lesions in the left main coronary artery (80%), left anterior descending artery (70% and 80% lesions in the proximal and middle thirds), and circumflex artery (70% in the proximal third), associated with extensive coronary calcification (Figure 2) and a Syntax Score of 32. The Heart Team discussed the case, and percutaneous treatment was chosen after considering high surgical risk (Euroscore II 7.74%, STS 5.82%), and clinical frailty assessed by a multidisciplinary team.

The procedure began with femoral puncture, followed by bilateral arteriography (Figure 3) to determine the best strategy. Both common femoral arteries had adequate calibers to accommodate the iVAC 2L device introducer. A significant atherosclerotic lesion was observed in the distal third of the right common femoral artery, and it was decided to position the iVAC 2L device through the left common femoral artery.

The left femoral artery was pre-closed with two Perclose Proglide devices, followed by insertion of an 18F hydrophilic introducer via a 0.035-inch high-support guidewire ("Amplatz Super Stiff"). Through the right femoral artery, a 0.035-inch guidewire was positioned in the non-coronary sinus to mark the level of the aortic valve. Subsequently, the iVAC 2L device was advanced, positioning its tip in the LV, 2 cm below the aortic valve, maintaining the bidirectional valve in the ascending aorta (Figure 1). The device was connected to the IABP console (intra-aortic balloon pump), configured for ECG triggering, with maximum inflation and 1:1 triggering, providing an estimated additional flow of approximately 2.0 L, given the patient's heart rate of approximately 70-80 bpm (Video 2).

We used a 3.5 7Fr EBU catheter for left coronary catheterization. Due to the presence of a severely stenotic lesion, pre-dilation was performed to allow evaluation with intravascular ultrasound (IVUS), which demonstrated a minimum luminal area of 1.88 mm², fibrolipid plaque, and significant calcification, in addition to ulceration in the LMCA and myocardial bridge in the distal segment of the artery (Figure 4). Lesion preparation was performed with dedicated balloons (Cutting Balloon and non-compliant balloon), with adequate results confirmed by IVUS. Subsequently, we implanted drug-eluting stents in the mid-LAD, ostial CX with minimal protrusion into the main, and proximal LAD with extension into the main, using the "Mini-Crush" technique. Post-dilation of the stents was performed, and carina adjustment was performed with the "Kissing-balloon" technique. Control IVUS was performed with adequate expansion and apposition of the struts, without complications (Figure 5). The entire procedure was performed under conscious sedation, without the use of vasoactive drugs. After the procedure, the device was removed, and hemostasis was performed with perclose, as mentioned. Final arteriography showed no vascular complications (Figure 5).⁸

High-risk PCIs are becoming increasingly frequent and with better results.^3–5 In this context, several MCADs were developed.¹⁴ Historically, IABP has been used in clinical practice for mechanical support in high-risk PCIs. Evidence from randomized clinical trials in this context has failed to demonstrate benefit in reducing major in-hospital cardiovascular events, although long-term analyses indicate a possible, albeit speculative, long-term benefit.^6,15 Thus, although IABP offers mechanical support and improves coronary and cerebral perfusion, the modest gain in cardiac output and the lack of evidence of cardiovascular benefits led to its non-recommended use in guidelines and consensus.^2,8

The operation and safety of the iVAC 2L device have been demonstrated in previous studies^12,13,16 providing a cardiac output of up to 2.0 L/min, approximately 3-4x the output provided by the IABP (Table 1). When compared to continuous flow devices such as Impella and ECMO, its advantages include a possibly more physiological pulsatile flow, ease of implantation, and the use of a balloon console already available in many centers, eliminating the need for a dedicated console. Compared to VA ECMO, iVAC has the advantage, as do Impella and IABP, of decompressing the left ventricle and decreasing systemic vascular resistance. The disadvantages include the 18F profile (compared to the 14F of the Impella CP) and the lower support (up to 2L compared to the 4.3L of the Impella or up to 10L/min of the VA ECMO) (Table 1).

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