Percutaneous Left Ventricular Assist Device Supported Aortic Balloon Valvuloplasty and Simultaneous Complex Percutaneous Coronary Intervention

Case

A 93-year-old independently living Caucasian female with hypertension and dyslipidemia presented with worsening dyspnea on exertion and pulmonary edema. Transthoracic echocardiography identified severe aortic valve stenosis and a significantly reduced left ventricular ejection fraction (LVEF) after presenting with New York Heart Association class III-IV heart failure symptoms and unstable angina. Transesophageal echocardiogram revealed LVEF of approximately 35% and severe aortic stenosis (AS) (aortic valve area 0.7-.08 cm²) and coronary angiography revealed a 90-95% heavily calcified distal left main (LM) stenosis, and 70-80% proximal left anterior coronary artery (LAD) and left circumflex (LCX) stenoses. The patient was seen by cardiothoracic surgery and deemed high risk for coronary artery bypass grafting (CABG) and surgical aortic valve replacement (SAVR) due to Society of Thoracic Surgery (STS) risk score >13%. She was then referred for high-risk percutaneous coronary intervention (PCI) and balloon aortic valvuloplasty (BAV). 

The patient underwent micropuncture access in the right common femoral artery (CFA) using a modified Seldinger technique. Descending aortogram confirmed adequate vessel size for large-bore sheaths and closure devices (Figure 1). Access was obtained in the contralateral CFA and bilateral Perclose (Abbott Vascular) vascular closure devices were placed using the pre-close technique. Both CFAs were then dilated up to a 12 French (Fr) sheath in the right CFA and a 13 Fr sheath in the left CFA. A 7 Fr venous sheath was placed in the right common femoral vein. A temporary transvenous pacer was positioned in the right ventricular apex with adequate sensing and pacing thresholds. Using a 6 Fr Amplatz left (AL)-1 diagnostic catheter and an .035-inch straight wire, the aortic valve was crossed and a 6 Fr angled pigtail catheter placed in the LV from the right CFA. Utilizing the same technique via the left CFA, the aortic valve was crossed again and a second pig-tail positioned in the LV apex. The baseline mean aortic valve gradient was measured at 45 mmHg. After anticoagulation with heparin, an Impella 2.5 (Abiomed) percutaneous left ventricular assist device (pLVAD) was then advanced over an .018-inch platinum wire from the left CFA and positioned in the LV, and hemodynamic support initiated with 2.2-2.3 L of cardiac output. An Amplatz extra-stiff exchange length wire was then positioned over the remaining pigtail from the right CFA access and an 18 mm ZMED-II valvuloplasty balloon (ZMed) was prepped and advanced, but unable to cross the aortic valve stenosis alongside the Impella. Subsequently, a 12 mm peripheral over-the-wire (OTW) balloon (Abbott Vascular) was prepped and delivered across the aortic valve. Two serial inflations were performed over 3-5 seconds alongside the Impella pLVAD (Figure 2), ensuring that the balloon inflated against the stiff metal alloy portion of the Impella without crushing the catheter. The patient remained hemodynamically stable throughout the serial inflations. The post-valvuloplasty gradient was significantly improved at 23 mmHg. 

An 8 Fr Extra Backup (EBU) guide (Boston Scientific) with side holes was used to engage the left main coronary artery via the right CFA access, confirming the heavily calcified LM stenosis (Figure 3). An .014-inch Pilot 50 coronary guidewire (Abbott Vascular) was advanced over a 1.25 x 10 mm OTW Apex balloon (Boston Scientific) through the 95% heavily calcified, eccentric distal LM stenosis into the distal LAD, and exchanged for a 330 cm, .014-inch Viper wire (Cardiovascular Systems, Inc [CSI]). Orbital atherectomy was performed using a 1.25 mm solid crown (CSI) with four separate passes in the LM and LAD. A 4.0 x 12 mm non-compliant (NC) Quantum Apex coronary balloon (Boston Scientific) was then used to dilate the ostial LAD and distal LM, followed by stenting with a 3.5 x 16 mm Synergy drug-eluting bioresorbable polymer stent (Boston Scientific) across the LCX, which was then unjailed after crossing the stent struts and balloon angioplasty across the stent struts. Finally, a 4.0 x 12 mm NC Quantum Apex balloon was used to further post-dilate the LM stent with good expansion, and excellent angiographic result and flow (Figure 4). The Impella pLVAD was then weaned off and externalized. Both CFAs were sealed with the Perclose devices successfully. The patient tolerated the procedure well without complications and was discharged home 3 days later. 

Discussion

We report a challenging case of a high-risk patient with complex valvular and coronary anatomy, who underwent successful pLVAD-assisted BAV with modest reduction in hemodynamic gradients, as well as complex PCI with atherectomy, angioplasty, and stenting of the LM, LAD, and LCX. 

Patients with complex coronary anatomic disease, reduced LV systolic function, and severe valvular heart disease present a challenge for safe and effective cardiovascular therapies. High-risk PCI can be safely and effectively performed with mechanical hemodynamic support in this difficult patient subset.^1-2 Hemodynamic support devices currently used in most facilities in the United States are the intra-aortic balloon pump (IABP, Maquet), TandemHeart (CardiacAssist), Impella (Abiomed) and extracorporeal membrane oxygenation (ECMO). IABP remains a lower profile, readily available device that can be rapidly deployed.³ It helps augment diastolic pressure, diminishes after-load, and thus reduces myocardial oxygen demand while increasing oxygen delivery. It generally only provides about 0.4-0.6 L/min of augmented cardiac output. The TandemHeart is a large-bore, percutaneous left atrial to iliac artery bypass that provides cardiac output of about 3.5 to 4 L/min of forward flow by standard implantation technique.⁴ However, it is not readily available in many institutions, which is also the case for ECMO. The Impella device provides forward systemic flow with an unloading effect on the failing LV. It maintains coronary blood flow in patients with poor hemodynamics during balloon inflation or stent deployment. This is accomplished by allowing for greater unloading, thus decreasing LV end-diastolic pressure, improving myocardial perfusion, and reducing myocardial ischemia.^5-8 The Impella device can provide between 2.5 to 5 L/min of forward flow depending on the specific device utilized. This device is approved by the FDA for temporal hemodynamic support and is expeditiously implanted. Since FDA approval, the Impella device utilization has had expanded indication for percutaneous support, including high-risk PCI, cardiogenic shock, post-pericardiotomy syndrome, and ventricular tachycardia ablative procedures.

In the PROTECT II randomized trial, IABP was compared to Impella 2.5 in patients undergoing high-risk PCI or unprotected LM, and with LVEF <30-35%. Impella use was associated with better hemodynamic support, a trend towards decreased major adverse cardiac events (MACE) at 30 days (35.1 vs 40.1%, P=.227) and a significant reduction in MACE at 90 days (40 vs 51%, P=.023).⁷ 

In other published case reports, the Impella 2.5 and Impella CP have been utilized successfully in hemodynamic support in BAV in high-risk patient subsets.^9-13 Impella CP is a version of the Impella 2.5 that can provide up to 4 L/min of forward flow in acutely ill patients; however, it requires one French size larger sheath and catheter. When utilizing either type of Impella pLVADs, one should consider downsizing the aortic valvuloplasty balloon by at least 2-3 mm of the LV outflow tract two-dimensional measurements to accommodate the Impella catheter across the aortic valve. For Impella 2.5 pLVADs, the IFU recommends against its use in critical aortic stenosis with AVA <0.6 cm². Also, ensure the balloon is inflated against the stiff metal alloy portion of the Impella to avoid crushing the catheter.

Our 93-year-old patient was estimated to have a very high operative mortality risk associated with surgery (STS risk score of 13%) with an intermediate SYNTAX score. Given complex coronary anatomy, depressed LV function, concomitant severe aortic stenosis, and unprotected LM disease requiring atherectomy, the PCI risk was significantly high, which necessitated a mechanical assist device to accomplish safe and successful PCI and BAV. Revascularization and valvuloplasty might improve the patient’s LV systolic function and hemodynamic profile over the short term, serving as a bridge to definitive transcatheter aortic valve replacement in the future.^11-13

References 

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