Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)
Primary Percutaneous Pericardiotomy for Malignant Pericardial Effusion (PMAP)
Pericardial effusion is a common complication in patients with metastatic malignancy. While
 pericardiocentesis provide effective relieve from life-threatening situation such as cardiac
 tamponade, recurrence of pericardial effusion after pericardiocentesis is common. We
 hypothesize that percutaneous balloon pericardiotomy in addition to standard
 pericardiocentesis with prolonged drainage can prevent pericardial effusion recurrence in
 patients with malignant pericardial effusion.
Pericardial effusion is a common complication in patients with metastatic malignancy with an
 incidence as high as 21%. The occurrence of malignant pericardial effusion significantly
 impacts on patient's survival and quality of life. While pericardiocentesis provide effective
 relieve from life-threatening situation such as cardiac tamponade, recurrence of pericardial
 effusion after pericardiocentesis is common and occurs in as high as 31% of patients.
 Retrospective data has shown that prolonged pericardial drainage might reduce the recurrence
 rate but at the cost of increased risk of infection and prolonged hospital stay. Surgical
 pericardiotomy was used in the past but was not shown to reduce recurrence over prolonged
 pericardial drainage and is associated with a higher rate of complications. Surgical
 pericardial window creation via a mini-thoracotomy might be an effective treatment and can be
 considered in patient with pericardial tamponade. The safety and feasibility of Percutaneous
 Balloon pericardiotomy (PBP) has been first described 1993 and has been shown to be an
 alternative treatment for patient with malignant pericardial effusion. However, no data is
 available on the efficacy of PBP in reducing the recurrence of pericardial effusion, in
 comparison with standard pericardiocentesis with prolonged drainage. We aim to perform a
 single centre, randomized, prospective, open label controlled pragmatic trial to compare
 percutaneous balloon pericardiotomy (treatment) to standard pericardiocentesis with prolonged
 drainage (control) in preventing pericardial effusion recurrence in patients with malignant
 pericardial effusion.
Inclusion Criteria:

 -  Patients with confirmed active malignancy AND,

 -  Presence of at least moderate (>10cm) pericardial effusion on CT or Echocardiography

 Exclusion Criteria:

 -  Patients unable to give an informed consent,

 -  Previous history of open-heart surgery

 -  Previous history of pericardial window or pericardial instillation of sclerosing
 therapy.

 -  Scheduled thoracic or cardiac surgery within the next 3 months

 -  Patients with contraindications for endovascular procedure such as disseminated
 intravascular coagulopathy or significant ongoing bleeding tendency, and systemic
 septicaemia.

 -  Patient with small or loculated pericardial effusion that is not accessible by
 subxiphoid approach.