Disclosure: The authors report no conflicts of interest regarding the content herein.

The authors can be contacted via Dr. Jon George at georgej@deborah.org.

Case

A 59-year-old male with a known history of ischemic cardiomyopathy and left ventricular ejection fraction of 20%, coronary artery disease, chronic atrial fibrillation, and chronic obstructive pulmonary disease (COPD) presented with exacerbation of heart failure (HF). He had been experiencing chronic angina as well as shortness of breath, assessed as New York Heart Association functional class 3. Despite optimal medical management for HF, the patient’s symptoms remained lifestyle limiting, with recurrent hospitalizations. For this reason, he was evaluated and opted to enroll as part of the research study involving percutaneous remodeling of the left ventricle (LV) using the Parachute (CardioKinetix) device. The screening echocardiogram (Figure 1A) and cardiac computed tomography (CT) (Figure 1B) revealed severely diminished LV ejection fraction with LV dilatation and apical wall dyskinesis.

The patient was brought to the cardiac catheterization suite. Access was obtained in the right radial artery and a 6 French sheath was placed. In addition, access was obtained in the right common femoral artery with another 6 French (Fr) sheath. The right femoral access was gradually upsized using serial dilators to the 16Fr device delivery sheath. A pigtail catheter was advanced from the right radial artery access and a left ventriculogram was performed, confirming severe LV dysfunction with an akinetic apex (Figure 1C). A second pigtail was advanced via the right common femoral artery, and was used to cross the aortic valve and position an Amplatz stiff wire in the LV apex. The Parachute delivery system was advanced over the Amplatz stiff wire, across the aortic valve, and into the LV apex (Figure 2A). The Parachute ventricular remodeling device was then advanced with the foot process positioned in the LV apex and confirmed by transthoracic echocardiography and ventriculography (Figure 2B). After confirmation, the entire device was deployed using the delivery system and inflation of the balloon in the LV apex (Figure 3). A final left ventriculogram was performed and confirmed adequate apposition of the Parachute device against the left ventricular wall with exclusion of the apex (Figure 4). The device was completely deployed and the delivery sheath was retrieved. A final ventriculogram confirmed adequate positioning and placement of the device (Figure 5A). Hemostasis was achieved in the right femoral artery access site by deployment of the Prostar (Abbott Vascular) vascular closure device and in the right radial artery access site using a RadAR vascular compression device (Advanced Vascular Dynamics). The patient was monitored overnight and discharged home the following day without complications.

The patient was seen in follow-up, and repeat transthoracic echocardiogram (Figure 5B) and cardiac CT (Figure 5C) confirmed stable position and placement of the Parachute device. He reported significant improvement in his HF symptoms following the procedure.

Discussion

Partitioning the left ventricle has many potential benefits, including decreased left ventricular volumes, reshaping of the dilated ventricle, decreased left ventricular radius and wall stress, improved contractility, and prevention of remodeling or induction of reverse remodeling.¹ The device reduces left ventricular volume, improving hemodynamics and leading to a reduction in the severity of the patient’s symptoms. The PercutAneous ventricular RestorAtion in Chronic Heart failUre paTiEnts (PARACHUTE) trial evaluated the safety and efficacy of the Parachute device.² The primary safety endpoint was the successful delivery and deployment of the Parachute implant through 6-month follow-up without the occurrence of major adverse cardiac events (MACE) secondary to the device. The secondary efficacy endpoints were the changes in hemodynamics and functional status from baseline to 6 months post-implantation. The inclusion criteria was New York Heart Association (NYHA) class II to IV heart failure of ischemic origin, left ventricular ejection fraction <40% by echocardiography, and antero-apical akinesis or dyskinesis secondary to a myocardial infarction. Some of the established exclusion criteria were untreated clinically significant coronary artery disease requiring intervention, acute myocardial infarction within 60 days of enrollment or patients with suspected evolving myocardial infarction at time of enrollment, cardiogenic shock within 72 hours of enrollment, and hemodialysis. 

Twenty patients were treated in the United States and 19 were treated at centers outside the U.S. There were four MACE events that were possibly device related: two cases of inadequate attachment of the device allowing migration into the left ventricular cavity necessitating surgical removal and two cases of hospitalization by 6 months.³ Non-device-related sepsis had also been reported. Patients also demonstrated improved quality of life at 6 months (P=0.03) and at 12 months (P=0.002). In addition, they also showed a modest improvement in 6-minute walk distance and left ventricular end diastolic volume. There was also a decrease in left ventricular end diastolic volume. The left ventricular ejection fraction also increased from 26.5% to 29.6%. Two years after the study, death rates in these patients remained below 10% and no strokes occurred even after discontinuation of dual antiplatelet therapy.³ By 3-year follow-up, 2 (6.5%) of 31 patients with successful implant had died from cardiac reasons, with no cardiac deaths occurring beyond 6 months post-treatment.⁴ 

The Parachute device is made from a nitinol frame of 16 struts with anchors at each strut tip and an ePTFE membrane.⁵ There are several sizes of the Parachute, chosen based on the screening echocardiogram and CT studies. It is implanted via the transfemoral route in the catheterization lab, with the foot of the device positioned in the apex and subsequently expanded to allow anchors at the tips of the struts to move into the myocardial wall to maintain position. 

We present herein a patient with refractory HF and the delivery of the investigational Parachute paraventricular remodeling implant, with significant improvement in symptoms over a short follow-up. 

References

1. Sharkey H, Nikolic S, Khairkhahan A, et al. Left ventricular apex occluder. Description of a ventricular partitioning device. EuroIntervention. 2006; 2: 125–127.
2. Mazzaferri EL Jr, Gradinac S, Sagic D, et al. Percutaneous left ventricular partitioning in patients with chronic heart failure and a prior anterior myocardial infarction: results of the PercutAneous ventricular RestorAtion in Chronic Heart failUre paTiEnts trial. Am Heart J. 2012; 163(5): 812-20.e1
3. Costa MA, et al. “Percutaneous Ventricular Restoration Therapy (PVRT) in patients with ischemic, dilated heart failure: 2-year clinical and echo outcomes of the first-in-human study of the Parachute left ventricle partitioning device.” EUROECHO 2012; held December 5-8, 2012, Athens, Greece.
4. Costa MA, Mazzaferri EL Jr, Sievert H, Abraham WT. Percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure: three-year outcomes of the PARACHUTE first-in-human study. Circ Heart Fail. 2014; 7(5): 752-758.
5. Oliveira GH, Al-Kindi SG, Bezerra HG, Costa MA. Left ventricular restoration devices. J Cardiovasc Transl Res. 2014; 7(3): 282-291.