Transcatheter Closure of Patent Ductus Arteriosus in Chinese Adults: Immediate and Long-term Results

Patent ductus arteriosus (PDA) is a common congenital cardiac anomaly. Depending on the size of the PDA, patients may be asymptomatic or in heart failure. Treatment is recommended because of the risk of infective endocarditis and congestive heart failure in the long term. The traditional treatment approach is surgical ligation under direct vision. However, surgical approach is invasive and associated with morbidity. In the past decade, transcatheter closure of PDA has been established as a safe and effective treatment alternative.1–5 The transcatheter approach is less invasive, associated with shorter procedural and recovery times, and has a better cosmetic outcome. Successful closure of PDA is likely to obviate the risk of endocarditis, arrhythmia and heart failure, and ensures a normal life-span. Although percutaneous closure of PDA in pediatric patients has been shown to be a low-risk procedure,1–5 experience in adult patients is still limited. In particular, adult patients are more likely to have a calcified and less distensible duct. They are exposed to a longer period of aorto-pulmonary shunting with possible secondary pulmonary hypertension and left ventricular dysfunction. Adult patients are more likely to have other comorbidities that limit their tolerance to surgical ligation. On the other hand, unlike pediatric patients, this procedure can be performed under local anesthesia in adult patients. We therefore conducted this study to address the immediate and long-term outcomes of adult patients who underwent transcatheter closure of PDA. Methods Patients. Adult patients (age >= 18 years) referred to a tertiary cardiology center for percutaneous transcatheter closure of PDA from November 1992 to October 1999 were recruited. Baseline evaluation included clinical history, physical examination, blood tests (complete blood count, liver and renal biochemistry and clotting profiles) and transthoracic and/or transesophageal echocardiogram. Procedures. Informed consent was obtained from all patients before the procedure. The procedure was performed under local anesthesia. All patients received a weight-adjusted dose of intravenous heparin (30–50 U/kg). Routine left and right heart catheterizations were performed to confirm the diagnosis and position of PDA, as well as to assess the shunt ratio. Details of the methodology have been previously reported.4,5 Due to the change in hospital policy, two different occluder devices were used in this study. Between 1992 and mid-1998, the Rashkind occluder (USCA Angiographics, Tewksbury, Massachusetts) was exclusively used. From mid-1998 onward, the Amplatzer duct occluder (AGA Medical Corporation, Golden Valley, Minnesota) was used. Complete closure was confirmed by angiography immediately after the procedure. Within 24 hours, chest radiographs in the posteroanterior and lateral positions were obtained to assess the device position and for future reference. Important complications of the procedure reported and defined in our study included post-release embolization of the device into either branch of the pulmonary artery or aorta, occluder-related endocarditis or hemolysis, and protrusion of the occluder arms into the left pulmonary artery and subsequent reduction in left pulmonary perfusion. Follow-up. At follow-up, all patients were reassessed with respect to their symptomatic status and exercise tolerance. Cardiovascular examination was performed with special attention to residual murmur. Two-dimensional transthoracic echocardiography with color flow mapping was performed to detect residual turbulence in the main, left and right pulmonary arteries. Left ventricular function was also evaluated. A chest radiograph was taken to detect device migration and wire fracture. Markers of hemolysis including hemoglobin level (Hb), reticulocyte count, lactase dehydrogenase (LDH), bilirubin, Coomb’s test and haptoglobin were checked. Pulmonary perfusion scintigraphy was performed using 99mTc-labeled human albumin macroaggregates and a gamma camera. After intravenous injection, the macroaggregate particles (5–20 µm) were homogeneously distributed in the lungs through trapping of particles in the precapillary pulmonary arterioles during their first pass, enabling the study of pulmonary radioactivity distribution that reflected the pulmonary blood flow. Patients in pregnancy at the time of follow-up were excluded. All scintigraphies were performed by the same investigator without knowledge of the details of the PDA closure procedure. Results Patient characteristics. Twenty-five patients (21 female, 4 male) were included in this study (Table 1). Mean patient age at the time of the procedure was 34 ± 11 years (range, 18–59 years). Mean body height and weight were 159 ± 7 cm (range, 152–173 cm) and 53 ± 10 kg (range 40–80 kg), respectively. The ductus size measured angiographically (minimal internal diameter) ranged from 1.3–6.6 mm (mean, 3.1 ± 1.3 mm). The mean pulmonary/systemic flow ratio (Qp/Qs) was 1.65 (range, 1.3–1.8). All but 3 patients were in good health prior to the diagnosis of PDA. Patient #3 had seronegative arthritis and was on oral steroid therapy. Patient #6 had pulmonary tuberculosis and was on anti-tuberculosis medications. Patient #10 had type 1 diabetes mellitus and was on insulin therapy. Among the 25 study patients, twenty-two were referred to us after incidental finding of a heart murmur. Three patients were already known to have PDA soon after birth but did not receive formal medical attention until antenatal visit when they were referred. All denied impaired exercise tolerance and were classified under New York Heart Association (NYHA) functional class I prior to the occlusion procedure. Procedures. Out of the 25 patients recruited, twenty-four successfully underwent percutaneous closure of the PDA as documented by angiography, giving an initial success rate of 96%. All procedures were carried out under local anesthesia. The average procedural and fluoroscopy times were 54 ± 14 minutes and 14 ± 4 minutes, respectively. Mean hospitalization period was 4 days (range, 3–5 days). The procedure was unsuccessful in 1 male patient who weighed 80 kg with a height of 172 cm. He was found to have very poor visualization under x-ray fluoroscopy and therefore the position of the PDA could not be accurately assessed. The procedure was abandoned to avoid malposition and subsequent dislodgement of the device. He subsequently underwent surgical ligation of the PDA. A Rashkind prosthesis was deployed in 79% of patients (19/24; a 17 mm device was deployed in 16 patients and a 12 mm device was deployed in 3 patients) and an Amplatzer duct occluder was deployed in 21% of patients (5/24; an 8 x 6 mm device was used in 4 patients and a 10 x 8 mm device was used in 1 patient). Within 24 hours, Doppler revealed cessation of flow across the ductus in the 24 patients. No patient required blood transfusion and there were no femoral arterial or venous complications. Subsequent evaluations included blood tests, chest x-rays, transthoracic echocardiography and pulmonary perfusion scintigraphy. One-month follow-up. Of the 24 patients who had successful procedures, one female patient who had a 17 mm Rashkind prosthesis was found to have continuous murmur at 1-month follow-up. Repeat angiogram showed minor displacement of the device. She subsequently underwent surgical ligation of the PDA together with removal of the occluder. This was considered a late failure case. Accordingly, the success rate at 1-month follow-up was 92% (23/25 patients). Late follow-up. The average follow-up period was 4 years (range, 2–110 months). Two-dimensional echocardiogram showed residual shunting in another 2 patients at 1-year and 1.5-year follow-up, respectively. Continuous murmur at the pulmonary area was detected in both patients. However, both of them refused restudy angiogram because they were asymptomatic. This gave a late success rate of 84% (21/25 patients). None of the patients had evidence of hemolysis. The mean hemoglobin level was 13.4 g/dl (normal, 11.5–16.5 g/dl) and the mean haptoglobin was 1.02 g/L (normal, > 0.8 g/L). There was no radiological evidence of device migration. The average left ventricular ejection fraction by 2-dimensional echocardiogram (M-mode) before and after the procedure was 68.3% and 65.5%, respectively (p = NS). Of the 23 patients followed regularly, one female patient complained of a decrease in exercise tolerance (NYHA class II) in the third year post-procedure. Further investigation showed hypochromic and microcytic anemia (Hb, 8.8). She admitted history of menorrhagia and was subsequently referred to a gynecologist for further investigation. All other patients were in NYHA class I. Pulmonary perfusion scintigraphy was performed in the 21 patients with successful occlusion of PDA. It was not performed in 4 patients because of initial (n = 1) and late (n = 1) procedural failure, pregnancy (n = 1) and refusal (n = 1). Among the 21 patients with scintigraphy performed, the average ratio of left to right pulmonary perfusion was 44.5 to 55.5. Three patients had significant reduction in left lung perfusion (Study limitations. This is a retrospective study of a small cohort of patients. In addition, two different types of occluder device were used during the study period. Long-term complications might not have emerged within the follow-up period. As far as we know, there have been no hard data for the relative left/right pulmonary perfusion pattern. In our study, left lung perfusion Conclusions. Immediate and long-term follow-up of our 25 patients indicate that percutaneous closure of PDA in adults using the Rashkind prosthesis or Amplatzer duct occluder is a safe and feasible procedure. It is associated with an acceptable success rate. There was no mortality related to the procedure and morbidity was minimal. This should be a feasible alternative to patients who are either not fit for open-chest surgery or who prefer a less invasive approach.

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