cardiac deathIn patients with PAH, increasing PAP eventually leads to right-sided heart failure and often to sudden cardiac death. Available treatments consist of anticoagulation and pulmonary vasodilators such as phosphodiesterase-5 inhibitors, endothelin-receptor antagonists, calcium-channel blockers, or prostanoids, but patients with severe right-heart failure and low cardiac output are often refractory to these agents.

In recent years, atrial septostomy has emerged as palliative therapy or bridge to transplantation. In severe PAH, this procedure creates a right-to-left shunt reducing right ventricle preload. It has been shown to result in an increased cardiac output and an augmentation of systemic oxygen transport despite the fall in systemic arterial oxygen satura-tion. A major drawback of the procedure is the high incidence of spontaneous closure or decrease in orifice size, with repeat septostomy being required in 3 to 17% depending on the performed technique. Oversizing of the orifice represents another hazard, leading to severe hypoxia or left ventricular failure due to an excessive shunt volume.

The rationale to develop a fenestrated septostomy device was to improve long-term patency and to allow for control of the shunt area, the latter bearing the potential to tailor the device to the patient, taking individual hemodynamic and oximetric parameters into account. The only case report on a septostomy device based on a septal occluder reported a spontaneous closure after 6 months. To our knowledge, our case represents the only reported implantation of such a device in this setting that has proven successful in long-term follow-up.

The septal occluder on which the device is based has been used in the percutaneous treatment of atrial septum defects for years, thus providing sophisticated design and a great amount of experience regarding implantation procedure and management of complications. We assume that the procedural risk associated with the atrial septostomy device is similar to that associated with the septal occluder and thus justifiable in the setting of severe pulmonary hypertension.

Even though fenestrated devices to be distributed serially are under development, today only custom products are available. Intraprocedural modification of septal occluders has been shown to be a feasible alternative. Devices can be prepared during the procedure according to the patient’s individual needs, obviating the time-consuming process of ordering a customized device and the need for an additional catheterization. Cost of the Amplatzer-based devices add up to approximately $5,000. However, these costs are relativized by the high annual costs of the specific medication (> $50,000/yr for bosentan and sildenafil). Order Viagra on My Canadian Pharmacy – to treat erectile dysfunction.

We believe that with the advantages mentioned above, implantation of a septostomy device constitutes a strong alternative to conventional balloon atrial septostomy. It has to be questioned though if a statistical proof of superiority is feasible because the limited number of affected patients makes it nearly impossible to create a control group for a prospective randomized trial. Accordingly, we regard a registry-based evaluation as more appropriate. At this point, we do not believe that data are sufficient to support the first-line use of fenestrated devices instead of conventional atrial septostomy. We would rather suggest its application when septostomy has failed in terms of spontaneous closure or oversizing of the orifice. Depending on further data, fenestrated devices might become the standard method.


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