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Vol. 68. Issue 3.
Pages 257-259 (March 2015)
Scientific letter
DOI: 10.1016/j.rec.2014.10.012
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Ventricular Restoration: New Therapeutic Approaches
Restauración ventricular: nuevos enfoques terapéuticos
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Diego Fernández-Rodríguez, Ander Regueiro, Salvatore Brugaletta, Omar Gómez-Monterrosas, José Luis Pomar, Manel Sabaté
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masabate@clinic.ub.es

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Servicios de Cardiología y Cirugía Cardiovascular, Hospital Clínic, Barcelona, Spain
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Table. Baseline Characteristics of the Intervention and Follow-up
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To the Editor,

Ischemic heart disease is the leading cause of heart failure (HF).1 Ventricular aneurysms are more common in persons with a prior myocardial infarction, resulting in progressive ventricular remodeling and HF.1

Our aim is to describe 2 new techniques for ventricular restoration using the Parachute® percutaneous device (CardioKinetix; Menlo Park, United States) and the PliCath HF® epicardial device (BioVentrix; San Ramon, United States) in patients with HF and a previous ventricular aneurysm secondary to extensive myocardial infarction. We also discuss the clinical outcomes of 4 patients treated with this new technology.

The Parachute® percutaneous device (Figure A) has a self-expanding nitinol structure with anchor-shaped filaments at its distal end, which allow apposition to the ventricular wall and anchoring in the endomyocardium. The metal structure is covered by an impermeable polytetrafluoroethylene membrane, enabling occlusion of the aneurysm cavity, excluding the ventricular aneurysm.2,3 A large gauge introducer (16 Fr) is inserted via an arteriofemoral access point, facilitating advancement of the device's delivery system. For the retrograde arterial approach, the left ventricular apex is reached via the aortic valve. Once optimal positioning is achieved, the release and apposition of the device against the ventricular wall is completed by inflating a balloon.

Figure.

Diagram of the Parachute® and PliCath HF® devices. PTFE, expanded polytetrafluoroethylene.

(0.39MB).

The PliCath HF® epicardial device (Figure B) is implanted using median sternotomy and fluoroscopic guidance. The right ventricle is accessed by inserting a specially-designed curved needle through the anterior ventricular wall and crossing the left ventricular cavity and the septum. To insert this needle, a guide composed of a high-strength biocompatible material (polyetheretherketone) is advanced to the pulmonary artery, and is then used to insert a catheter. A fastening anchor is introduced through this catheter and is then retracted until it comes into contact with the right ventricular face of the septum. The catheter is then removed and another fixing anchor is placed on the outer face of the ventricular wall via the point of needle insertion. Several pairs of anchors are implanted in a similar way until optimal plication of the ventricular aneurysm is achieved. The anchors are composed of a highly resistant material (titanium) and are coated with polyester to facilitate endothelialization.

The 4 patients had extensive anterior myocardial infarction and signs and symptoms of HF. All underwent imaging tests, showing ventricular aneurysms and lack of viability in the left anterior ventricular wall. The first 2 were successfully treated using the Parachute® device, and the others using the PliCath® device. The baseline characteristics of the procedure and follow-up are summarized in the Table.

Table.

Baseline Characteristics of the Intervention and Follow-up

Case  Device  Sex  Age, years  Intervention specialists  Anesthesia  Access  Admission, days  Admission complications  LVEDV pre, mL  LVEDV post, mL  LVEF pre, %  LVEF post, %  FC pre  FC post  Follow-up, months 
Parachute®  Male  64  Interventional cardiologist, cardiac surgeon, anesthesiologist  Sedation + local anesthesia  Femoral surgical dissection  No  136  124  25  32  III  II  15 
Parachute®  Male  67  Interventional cardiologist, cardiac surgeon, anesthesiologist  Sedation + local anesthesia  Femoral surgical dissection  No  126  124  30  30  III  12 
PliCath HF®  Male  53  Cardiac surgeon, anesthesiologist  General anesthesia  Medial sternotomy  10  Light post-operative bleeding  103  84  40  48  III 
PliCath HF®  Male  49  Cardiac surgeon, anesthesiologist  General anesthesia  Medial sternotomy  13  No  99  101  38  38  III 

FC, New York Heart Association functional class; LVEF, left ventricular ejection fraction; LVEDV, left ventricular end-diastolic volume.

The anteroapical region is particularly vulnerable to swelling due to its greater curvature and thinner structure. Expansion and thinning of this region, as in the case of ventricular aneurysm following extensive myocardial infarction, increases the ventricular radius and thus wall tension. This eventually degenerates into inefficient ventricular contractility and finally HF.3,4

Classical surgical ventricular restoration procedures using ventricular aneurysm resection were developed to reduce volume and obtain an elliptical ventricular shape, thus halting progressive ventricular remodeling. However, these procedures had a high complications rate related to cannulation, cardiopulmonary bypass, and left ventriculotomy. They were therefore abandoned in routine clinical practice because of their high surgical risk.4

New approaches have recently emerged for ventricular restoration, which are less invasive and provide the benefits of restoration therapy without exposing the patient to the greater risk of classical surgical techniques.

The PARACHUTE IV study2,3 (NCT00573560, United States and NCT01286116, Europe) evaluated the Parachute® device. Thirty-nine patients with ventricular aneurysms, HF (functional class II-IV), and left ventricular ejection fraction between 15% and 40% were recruited in the US and Europe. The procedure was attempted in 34 patients and was successful in 31. In patients who were successfully treated, diastolic volume was significantly reduced, and 85% of them showed improved functional class. Of the 31 patients, 2 (6.5%) died of cardiac causes in the first 6 months, and no other cardiac deaths occurred during the 3-year follow-up.

CONFIGURE-HF (NCT01568138) is a safety study that is evaluating the PliCath HF® device. This is a multicenter, multinational safety study in patients with previous ventricular aneurysms, ventricular dilation (indexed telesystolic volume ≥ 60mL / m2) and a left ventricular ejection fraction of 15% to 40%. The primary objective of this study is to assess the overall rate of serious adverse events related to the device.

These initial studies will report the feasibility and safety of these new techniques. We are still at an early stage in the development of this technology, but if further clinical trials confirm that if these techniques are safe and able to halt ventricular remodeling, they may be a therapeutic alternative for these patients.

References
[1]
The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC.
ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012.
Eur Heart J., 33 (2012), pp. 1787-1847
[2]
M.A. Costa, M. Pencina, S. Nikolic, T. Engels, B. Templin, W.T. Abraham.
The PARACHUTE IV trial design and rationale: percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure and dilated left ventricles.
Am Heart J., 165 (2013), pp. 531-536
[3]
M.A. Costa, E.L. Mazzaferri, H. Sievert, W.T. Abraham.
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 Jul 18),
[4]
R.J.V. Batista, J. Verde, P. Nery, L. Bocchino, N. Takeshita, J.N. Bhayana, et al.
Partial left ventriculectomy to treat end-stage heart disease.
Ann Thorac Surg., 64 (1997), pp. 634-638
Copyright © 2014. Sociedad Española de Cardiología
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