Clinical Utility of TandemHeart® for High-Risk Tandem
Procedures: Percutaneous Balloon Aortic Valvuloplasty followed
by Comple

Sanjay Rajdev, MD, Adil Irani, MD, Samin Sharma, MD, Annapoorna Kini, MD
Sanjay Rajdev, MD, Adil Irani, MD, Samin Sharma, MD, Annapoorna Kini, MD

Percutaneous left ventricular (LV) assist devices are increasingly being used during high-risk percutaneous coronary interventional (PCI) procedures.1–4 These devices provide reliable short-term hemodynamic stability in complex cases during which the interventionist has the luxury of time to successfully carry out the procedure. The TandemHeart® (Cardiac Assist, Inc., Pittsburgh, Pennsylvania) is a relatively recent introduction to the available percutaneous nonpulsatile centrifugal LV assist devices that can be used to support poorly functioning ventricles in a variety of high-risk interventions. Additional applications of LV assist devices include supporting the heart in its recovery from cardiogenic shock secondary to myocardial infarction5,6 and post-cardiotomy heart failure.7 The application of this device during percutaneous aortic valve replacement in an animal model has been reported,8 and a recent report was published about its use in high-risk percutaneous balloon aortic valvuloplasty (BAV) in humans.9,10 The encouraging results of LV assist devices have been duplicated in assisting the right ventricle during right ventricular failure secondary to severe pulmonary artery hypertension with improved hemodynamics in the short term.11

As experience with the device accrues, more complex procedures are being attempted with TandemHeart assistance. We report our experience utilizing the TandemHeart device for periprocedural hemodynamic support in a patient with severe calcific aortic stenosis with triple-vessel coronary artery disease and severely depressed LV systolic function treated with BAV and PCI in the same setting. The patient was refused by surgeons on account of prohibitive mortality risk due to severely depressed LV function (estimated left ventricular ejection fraction [LVEF] 10%) and high pulmonary artery pressures.

Case report. The patient was a 58-year-old male who was referred to our center from an outside healthcare facility for consideration of percutaneous BAV and complex PCI. Cardiac catheterization at this facility revealed triple-vessel coronary artery disease with severe LV dysfunction (LVEF of 10%), moderate- to-severe mitral regurgitation, severe valvular aortic stenosis and moderately severe pulmonary artery hypertension. The patient had NYHA Class III–IV symptoms of heart failure. His past medical history was significant for smoking, dyslipidemia, peripheral vascular disease and episodes of congestive heart failure requiring multiple hospitalizations for which a biventricular implantable cardioverter defibrillator was implanted. His medications included a once-daily dose of the following: aspirin 81 mg, lisinopril 10 mg, digoxin 0.125 mg, simvastatin 20 mg, furosemide 40 mg and potassium chloride 10 mEq.

A two-dimensional transthoracic echocardiogram confirmed an LVEF of 10% with severe aortic stenosis and severe mitral regurgitation. The aortic valve was thick and calcified with severely restricted mobility. It showed prominent systolic doming with post-stenotic dilatation of the aorta. The peak instantaneous and mean gradients using continuous-wave Doppler across the aortic valve were 55 and 34 mmHg, respectively. The aortic valve area using continuity equation was calculated to be 0.6 cm2. Pulmonary artery systolic pressure by tricuspid regurgitation jet was estimated at 80 mmHg.
The patient was taken to the cardiac catheterization laboratory for a scheduled BAV followed by PCI. Vascular accesses (right- and left-sided common femoral arterial and venous) were obtained employing the standard Seldinger technique. Baseline right and left heart catheterization was performed. The right heart catheterization showed pulmonary artery pressures of 70/34 with a mean of 46 mmHg. The mean pulmonary capillary wedge pressure was 26 mmHg. His pulmonary vascular resistance was 11.8 Wood Units/m2. The patient’s BSA and pulmonary artery saturation was 52%. Cardiac output and index by Fick’s method were 2.9 L/minute and 1.7 L/minute/m2, respectively. The aortic valve was crossed using an AL1 diagnostic catheter and a 0.035 inch straight-tip Glidewire®2, respectively
(Boston Scientific Corp., Natick, Massachusetts). Mean aortic valve gradient and area were estimated to be 23 mmHg and 0.6 cm

Procedure for TandemHeart placement. The Tandem- Heart device was placed as described previously.10 A pigtail abdominal aorto-gram was performed to assess the ileo-femoral arterial anatomy. When suitable arterial anatomy was observed (absence of severe/ diffuse ileo-femoral disease or extreme tortuosity), a decision to place large bore TandemHeart arterial cannulae was made. Under mild sedation, arterial access sites were presutured using the Perclose (Abbott Vascular Devices, Abbott Park, Illinois) preclosure suture mediated devices using a specified protocol.
From the right femoral venous approach, a transseptal puncture was performed using a Brockenbrough needle and Mullins sheath. After confirming the position of the Mullins sheath in the left atrium, it was exchanged for a 21 Fr TandemHeart transseptal cannula over a 0.038 inch J-tip 260 cm Amplatz Super Stiff™ guidewire (Boston Scientific Corp., Natick, Massachusetts). A 15 Fr femoral arterial perfusion cannula was placed through the right femoral artery with the distal end of the cannula lying above the aortic bifurcation. The femoral venous and arterial cannulae were connected to their respective conduits of the TandemHeart pump after de-airing according to the specified protocol. At this point, 5000 units of unfractionated heparin were administered with a target activated clotting time > 300 seconds. The pump was then connected to the TandemHeart controller and its speed adjusted to provide a support of 2.5 L/minute.

BAV procedure. A J-tip 260 cm Amplatz Super Stiff guidewire was placed in the LV through the diagnostic catheter. Next, a 20 mm wwWx 6.0 cm Z-Med II balloon dilatation catheter (Numed Inc., Hopkinton, New York) was placed across the aortic valve over the Amplatz wire. A single inflation across the aortic valve was performed which resulted in disappearance of the waist on the balloon. The patient tolerated the procedure well without any complications. A repeat right and left heart catheterization revealed a cardiac output of 3.8 L/minute, and the corresponding aortic valve gradient and areas were 9 mmHg and 1.3 cm2, respectively.
Procedure for PCI. Coronary angiogram performed using Iopamidol showed an anomalous left circumflex artery arising from the right coronary sinus with significant atherosclerotic obstructive disease in all 3 epicardial coronary arteries.
Using an FCL 4.0 Fr guide catheter, the left main coronary artery was engaged and critical lesion in the mid segment of left anterior descending artery (LAD) and first diagonal was profiled in the A-P cranial angiographic projection. The diagonal was wired and balloon dilated, the LAD was wired, balloon dilated and stented using a drug eluting stent. Following satisfactory results post PCI, the TandemHeart pump output was slowly reduced and then shut off while observing the patient for hemodynamic variables. The TandemHeart pump was then removed and femoral artery access sites were closed deploying the pre-closure Perclose sutures. The femoral venous access sites were manually compressed.

Hospital course. The patient’s in-hospital course was uneventful with no bleeding complications, and he was discharged the next day with a plan for revascularization of the anomalous left circumflex artery 4 weeks later.

Discussion. The TandemHeart is a novel device with better metabolic and hemodynamic periprocedural physiology than an intra-aortic balloon pump, which is primarily used to mechanically assist the heart in the setting of severe LV dysfunction.6 Experience with the TandemHeart in patients with severe aortic valvular stenosis and very poor LV function has been limited to a few case reports. Recently, its use was illustrated in patients with critical aortic valvular stenosis.9,10 The first patient described had cardiogenic shock with multiorgan failure secondary to critical valvular stenosis; reversal of the patient’s cardiogenic shock was prompt and hemodynamic and metabolic parameters improved dramatically when the patient was placed on TandemHeart support.9 The second patient was at a high risk for periprocedural adverse cardiac events due to low biventricular ejection fraction and severe pulmonary artery hypertension.10 A percutaneous BAV was successfully performed on TandemHeart support without any periprocedural hemodynamic instability. We describe a similar, albeit more complicated, patient who had, in addition to severe aortic stenosis, coexisting severe triple-vessel disease with an anomalous and diseased LCx artery. Considering the complexity of the procedure, we anticipated a lengthy procedure, thus more durable periprocedural hemodynamic support like the TandemHeart was considered prudent. After uneventful BAV, angioplasty and stenting of the significant mid-LAD lesion, the presumed culprit, was successfully performed. A strategy of provisional side branch stenting was employed and the diagonal was only balloon-dilated.
Tandem percutaneous interventions in this patient were performed in view of limited surgical options, short of a cardiac transplant. The patient’s severely depressed LVEF may have been caused both by ischemic heart disease and afterload mismatch due to severe aortic stenosis. BAV and arterial revascularization might improve the patient’s LV systolic function and hemodynamic profile over a period of time. Also, this might make him a better and lower-risk surgical candidate for a more durable procedure like aortic valve replacement with or without coronary artery bypass graft surgery.12
However, we believe in the setting of persistent LV dysfunction after BAV and arterial revascularization, cardiac transplant or percutaneous heart valve placement remains an alternative, viable last-resort option. Percutaneous heart valve placement for inoperable patients with severe calcific aortic stenosis and severe LV dysfunction has demonstrated benefit13 with encouraging short-14 and mid-term follow-up results.15
This case demonstrates the safety and feasibility of using the TandemHeart percutaneous LV assist device for multiple high-risk percutaneous interventions in a single setting. To the best of our knowledge, this is the first reported case of the use of TandemHeart for temporary hemodynamic support in tandem high-risk procedures.




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