Elective Left Ventricular Support by Impella System 2.5 L
during Percutaneous Mitral Valve Repair in Patient with
Severe Mitral Regurgitation and Acute Decompensated Heart
Failure.
Autor
Dr. Michael Edward Donahue
Tutor Scientifico
Prof. Passino Claudio
Tutor Aziendale
Dr. Sergio Berti
Master Universitario di II livello Cardiologia Interventistica Cardiovascolare e Strutturale
Anno Accademico
2 Introduction
Percutaneous mitral valve repair has emerged as an effective and safe therapy in patients with severe mitral regurgitation (MR) deemed inoperable and/or at high risk for cardiac surgery1, 2. The transcatheter approach, indeed, reduces the severity of MR with a substantial low perioperative morbidity and mortality risk, allowing an improvement in quality of life and a reduction in hospitalizations for heart failure2-5. In patients undergoing surgical mitral valve repair, the presence of severe left ventricular (LV) systolic dysfunction has been associated with increased peri-operative morbidity and mortality6. This unfavourable effect may occur even following percutaneous mitral valve repair. In this instances, intensive inotropic treatment may result in limited or suboptimal effects, and elective circulatory support, by reducing the increased wall stress caused by the elimination of the regurgitant flow into the left atrium, may improve in-hospital outcome7.
Case report
A 70-year-old man was admitted to the intensive care unit of the Clinica Mediterranea suffering from acute decompensated heart failure (NYHA functional class IV) due to severe ischemic cardiomyopathy. The patient previously underwent to coronary artery bypass surgery and implantation of an implantable cardioverter-defibrillator and cardiac resynchronization. Heart rate was 85 bpm and systemic blood pressure was 90/60 mmHg. Baseline kidney function was depressed (estimated glomerular filtration rate = 25 mL/min/1.73 m2) and urine flow rare was <50 ml/h. A baseline trans-thoracic echocardiography (TTE) showed a severe LV systolic dysfunction (LV ejection fraction [LVEF] = 15%) and a severe MR. Baseline brain natriuretic peptide (BNP) value was 1003 pg/mL. Intensive intravenous inotropic support was initiated, including dobutamine
3 (10 µg/Kg/min) and levosimendan (0.1 µg/Kg/min). The trans-esophageal echocardiogram (TEE) confirmed the severity of the MR, clarified its mechanisms (i.e., tethering of the posterior mitral leaflet and pseudo-prolapse of the anterior mitral leaflet), and showed a severe spontaneous echo contrast (SEC) in left atrial appendage. Due to the high surgical risk (EuroSCORE II: 48.0%, Society of Thoracic Surgeons’ [STS] score 11.5%) and the satisfying echocardiographic mitral valve characteristics, the percutaneous MV repair with the MitraClipTM System was deemed indicated. The procedure was performed through the right femoral vein under general anesthesia and 2D and 3D TEE guidance. The MitraClipTM system (Abbott Vascular Inc., Santa Clara, CA, USA) consists of a tri-axial catheter system with an implantable clip8.
Elective mechanical circulatory support was carried out before the procedure by the ImpellaTM system 2.5 L (Abiomed, Danvers, MA) . The device consists of a pigtail-like catheter
within which is housed a micro-axial non-pulsatile pump capable of enhancing cardiac output by 2.5 L/min and requires a 12 Fr femoral sheath9. The ImpellaTM system was advanced through the left femoral artery into middle LV cavity, according to the recommendations9. Right heart catheterisation was performed using a 6 F single-lumen, balloon-tipped Swan–Ganz catheter to obtain pulmonary capillary wedge pressure (PCWP), pulmonary artery pressure (PAP) and pulmonary artery oxygen saturation. Cardiac output (CO) was calculated by the Fick method.
Following trans-septal crossing, 70 IU/kg of unfractionated heparin was administered, maintaining an activated clotting time of > 250 sec throughout the procedure. Then the 24 Fr guiding catheter was advanced into the left atrium (LA) and the delivery system was positioned in the LA (Fig 1). Hence the distal steerable part was manipulated in the atrium to obtain a perpendicular and central position with respect to the mitral coaptation line. Once the system has been properly aligned, the clip with opened arms was advanced into the LV, and under TEE guidance the arms grasped the leaflets. Finally one clip was successfully implanted centrally between A2-P2 site without complications. Intra-procedural TEE confirmed the reduction in MR
4 from severe to mild (Fig. 2) without significant gradient across the valve (Fig. 3). Haemodynamic changes during and after the procedures are shown in Table 1.
The patient has been weaned from the ImpellaTM system support decreasing gradually the performance level of the device and the system was explanted at 24 hours following the intervention while high-dose of dobutamine was still administered. Dobutamine infusion was therefore de-escalating, and therefore stopped at 48 hours following the intervention. The patient was discharged on postoperative day 5, in NYHA functional class II. A pre-discharge TTE showed an improved LVEF (25%) and a reduction of left ventricular systolic and diastolic diameters. Echo-cardiographic parameters before and after the procedure are depicted in Table 2. At three-month follow up the patient was asymptomatic with a NYHA functional class I-II. TTE showed mild MR and improved LV function (LVEF = 26%).
Discussion
Mitral regurgitation (MR) is the second most frequent valvular heart disease that requires treatment in the worldwide and is present approximately in 35% to 50% of patients with chronic heart failure (HF)10. The surgical repair or replacement of mitral valve (MV) represents the treatment of choice for severe MR. Despite the current literature suggests that functional MR in patients with advanced heart failure and left ventricular dysfunction can be corrected with a low operative mortality, there are still concerns about the appropriateness of surgery in this setting11. It has been reported that, among patients undergoing surgical isolated MV repair, 1) and early reverse cardiac remodelling occurs, characterized by a significant decrease of the LV end-diastolic diameter without relevant changes in LV end-systolic diameter 12, 13, 2) a lower LVEF before surgery is an independent predictors of a lower postoperative LVEF14; 3) the mean decrease in LVEF is similar to that observed after mitral valve replacement (-8.8 vs -8.9; P = 0.071) 14; and 4) a pre-operative heart
5 failure (HF) has been associated with a 46% increased risk of operative mortality6, and
postoperative low cardiac output15. In this instances, elective temporary mechanical circulatory support, by reducing the increased LV wall stress caused by the elimination of the regurgitant flow into the left atrium, may improve in-hospital outcome7.
The percutaneous repair of the MR is a therapeutic option which serves as an alternative to conventional cardiac surgery in selected patient judged as inoperable for a high or prohibitive surgical risk 1, 16. Initial clinical experience shows that the percutaneous MV repair in patients with LV dysfunction can be performed safely with promising results in term of efficacy2, 4, 5, 8, 17, 18. Nevertheless, due to the high-risk characteristics of the patients deemed suitable for MitraClip procedure, the need for elective circulatory support should be taken into account. Indeed, although in the EVEREST II (Endovascular Valve Edge-to-Edge Repair) trial patients with severe LV systolic dysfunction (i.e., LVEF <20% and/or LVEDD >60 mm) were excluded2, several studies showed that percutaneous edge-to-edge repair may be safely performed in surgical high-risk patients with severely impaired LV systolic function5, 17, 18. In the Percutaneous Mitral Valve Repair in Cardiac Resynchronization Therapy (PERMIT-CARE) study, however, acute intra-procedural heart failure occurred in 7/51 (14%) patients, even with inotropic support either before and during the procedure17. Patients enrolled in that study had chronic moderate-to-severe or severe functional MR and severe LV systolic dysfunction (LVEF = 27.1±8.7%). In the TRAnscatheter Mitral valve Interventions (TRAMI) registry18 32.9% of patients had a LVEF <30%, and intra-procedural low cardiac output occurred in 9/1164 patients (0.77%). Taramasso M et al. reported that, although an high inotropic support (defined as adrenaline dosage >0.5 γ/kg/min or association of two or more i.v. inotropic drugs), hemodynamic support by an intra-aortic balloon pump (IABP) was necessary in 14/109 (13%) patients, and in one patient transient circulatory support with the extracorporeal membrane oxygenation (ECMO)4. In the ACCESS-EU study5, on the contrary, no intra-procedural acute heart failure occurred, even though 62/562 (11%) patients had LVEF ≤20% and 4.9% were in
6 cardiogenic shock at the time of the index procedure. Acute hemodynamic measurements obtained before and at least 10 min after MitraClip device deployment showed 1) a 0.7 l/min mean cardiac output increment ( from 3.7±1.5 l/min to 4.4±1.9 l/min), 2) a 3.5 mm Hg decrease in the PCWPe V-wave (from 23.0±10.8 mm Hg to 19.5±9.1 mm Hg) and 3) whereas all other hemodynamic parameters remained stable post-implant.
Postcardiotomy mechanical circulatory support has historically been used as a life-saving effort for patients who could not be weaned from cardiopulmonary bypass despite the administration of high-dose inotropic agents19. Recent refinement of the technology for percutaneous insertion and removal of temporary ventricular assist devices has facilitated and expanded their use19, 20. Circulatory support during MitraClip procedures has been provided by the intra-aortic balloon pump (IABP)4. However, despite ease of implantation, IABP provides limited
(0.5 L/min) augmentation of cardiac output which may be insufficient in case of severely depressed LV function21. The ImpellaTM circulatory support catheter provides a higher rate of flow and, when compared to IABP, may allow for greater offloading of the left ventricle, which may help to decrease both systolic and diastolic wall stress. In the PROTECT II randomized trial, comparing ImpellaTM 2.5 L with IABP in patients undergoing high-risk PCI with severe LV systolic
dysfunction, ImpellaTM was associated with superior hemodynamic support and a significant reduction in major adverse cardiac event at 90 days9.
Conclusions
The ImpellaTM system seems to be a safe and effective option allowing circulatory support in
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9 Table 1. Invasive haemodynamic parameters.
Baseline After ImpellaTM After MitraClipTM
Mean PAP (mmHg) 33 26 27 Mean PCWP (mmHg) 26 21 22 PCWP V wave (mmHg) 30 23 25 MAP (mmHg) 75 79 79 CO (l/min) 3.93 4.82 4.85 CI (l/min/m2) 2.57 3.16 3.18 PVR (dyn×s×cm−5) 671 431 445
CI, cardiac index; CO, cardiac output; LVEDP, left ventricular end-diastolic pressure; MAP, mean arterial pressure; MVR, mitral valve repair; PAP, pulmonary artery pressure; PCWP, pulmonary capillary wedge pressure; PVR, pulmonary vascular resistance; SVR, systemic vascular resistance. PVR = mPAP x 80 /CO
Table 2. Echocardiographic parameters before and after the procedure.
Parameters Baseline After procedure 3 month follow-up
LVEF (%) 15 24 26 LVEDV (ml) 169 147 145 LVESV (ml) 147 118 115 LAV (ml) 71 62 62 E/A 3.96 3.89 3.93 E/E’ 17 16.03 11.97 MR 4+ 1+ 1+ TAPSE 15 17 19
LVEF = left ventricle ejection fraction; LVEDV = left ventricle end diastolic volume; LVESV = left ventricle end systolic volume; LAV = left atrial volume; MR = mitral regurgitation
10 Figure 1. 3D TEE during clipping procedure. The MitraClip is advancing into the left atrium.
11 Figure 2. Fluoroscopic image depicting the deployment of the MitraClip.
A = ImpellaTM 2.5 L; B = MitraClipTM; C = MitraClipTM delivery system; D = Swan-Ganz catheter; E = Implantable Cardioverter Defibrillator catheter.
A
D
E
B
12 Figure 3. TEE in intercommissural and view showing 4+ MR before the procedure (A) and the residual 1+ MR after the mitraclip deployment (B).
