First-in-Human Closed-Chest Transcatheter Superior Cavopulmonary Anastomosis

Abstract

BACKGROUND In the care of patients with congenital heart disease, percutaneous interventional treatments have supplanted many surgical approaches for simple lesions, such as atrial septal defect. By contrast, complex congenital heart defects continue to require open-heart surgery. In single-ventricle patients, a staged approach is employed, which requires multiple open-heart surgeries and significant attendant morbidity and mortality. A nonsurgical transcatheter alternative would be attractive. OBJECTIVES We sought to show the feasibility of catheter-only, closed-chest, large-vessel anastomosis (superior vena cava and pulmonary artery [PA] or bidirectional Glenn operation equivalent) in a patient. METHODS In preclinical testing over a decade, we developed the techniques and technology needed for nonsurgical crossing from a donor (superior vena cava) to a recipient (PA) vessel and endovascular stent-based anastomosis of those blood vessels. We undertook this transcatheter approach for an adult with untreated congenital heart disease with severe cyanosis and significant surgical risk. We rehearsed the procedure step by step using contrast-enhanced cardiac computed tomography and a patient-specific 3-dimensional printed heart model. RESULTS We described a first-in-human, fully percutaneous superior cavopulmonary anastomosis (bidirectional Glenn operation equivalent). The patient, a 35-year-old woman, was homebound due to dyspnea and worsening cyanosis. She was diagnosed with functional single ventricle and very limited pulmonary blood flow. The heart team believed surgical palliation conferred high operative risk due to the patient’s complete condition. With the percutaneous procedure, the patient suffered little morbidity and remained improved clinically after 6 months. CONCLUSIONS This procedure may provide a viable alternative to one of the foundational open-heart surgeries currently performed to treat single-ventricle congenital heart disease.

Transcatheter creation of bidirectional cavopulmonary connections by needle punctures in two patients

“…In previous animal experiences and in the first human case, the perforation of the vessels had been performed by high‐energy application to a perforation wire. The wire has to be placed and stabilized by a guiding catheter.…”

“…Surgical therapy to relieve congestion at right atrial level was declined by the surgical team due to multiple Fontan‐related comorbidities. After an interdisciplinary case conference, it was decided to offer the patient a transcatheter cavopulmonary connection . After thorough explanation of the particularity of the procedure, the patient gave his informed consent.…”

Transcatheter biventricular conversion in an adult patient with a 1.5 ventricle Glenn palliation and superior vena cava syndrome

“…7 More recently, percutaneous BDG creation, including a human case report, has also been described. 8,9 While these interventional advances for single ventricle palliation are important, frequently, there are borderline cases where the decision for a two-ventricle repair or one ventricle palliation is difficult. This case demonstrates the feasibility and utility of anticipatory planning in such borderline cases, arguing that a BDG could be performed with an intent to prepare the patient for a future takedown if, over time, there is adequate growth of the atrioventricular valve and ventricle.…”

X‐ray fused with MRI guidance of pre‐selected transcatheter congenital heart disease interventions

“…Although this study focused on prespecified, select congenital heart disease interventions, there are many other case types, including soft tissue interventions, where XFM may be invaluable for procedural guidance. Examples include targeted cardiac biopsy, recanalization of discontinuous vessels, transbaffle punctures for access to intracardiac structures in patients post Fontan or Mustard type surgical repairs, and transcatheter vessel anastomosis . These and other similar applications will likely be the target of future image fusion studies.…”

“…Although the significant case-control benefits were limited to fluoros- Mustard type surgical repairs, and transcatheter vessel anastomosis. 18 These and other similar applications will likely be the target of future image fusion studies.…”