THERAPY AND PREVENTIONCONGENITAL HEART DISEASE

Outpatient closure of the patent ductus arteriosus

DAVID L. WESSEL, M.D., JOHN F. KEANE, M.D., IRA PARNESS, M.D., AND JAMES E. LOCK, M.D.

ABSTRACT We have modified and applied to selected outpatients the transvenous approach tocorrection of patent ductus arteriosus (PDA) with the Rashkind PDA Occluder. Modifications includedestablishing the diagnosis and PDA anatomy before catheterization with echocardiography. Thesedation/anesthetic regimen was altered to meet the needs with respect to transcatheter PDA closurerather than diagnostic cardiac catheterization. Anticoagulation was avoided. A strategy for managementof pin entrapment in the foam was devised. Residual trans-PDA flow after umbrella placement wastemporarily occluded with balloon-tipped catheters. These modifications were used in 23 consecutivepatients with uncomplicated PDA. Closure was successful in each child. Nineteen of 23 patients weredischarged on the day of the procedure. No serious complications were encountered.Circulation 77, No. 5, 1068-1071, 1988.

IN 1939, Gross and Hubbard1 began the era ofcongenital heart surgery when they reported thefirst successful ligation of a patent ductus arteri-osus (PDA). The 7-year-old patient, who had anuneventful postoperative recovery, was hospitalized atthe Children's Hospital in Boston for a total of 22days; 6 hospital days because of "general interest" inthe case. Surgical management of the PDA has sincebeen highly refined to a very safe and effective pro-cedure, with the average hospitalization now lastingabout 1 week.

In recent years alternative methods of PDA closurehave been investigated. In 1967 Porstmann et al.2 intro-duced a transvascular closure technique (via cutdown);more recently, Rashkind and Cuaso3 described use ofa double umbrella device introduced percutaneously toachieve closure. Subsequently, Bash and Mullins4modified Rashkind's technique such that it could beaccomplished by a transvenous percutaneous ap-proach. Recent data on transcatheter closure indicate asuccess rate of about 65%; Rashkind et al.5 have noteda clinical success rate of about 84% in their most recentclinical study. We have further modified the transve-nous approach to achieve successful outpatient closureof a PDA reliably and safely.

From the Departments of Anesthesia and Cardiology, The Children'sHospital, and the Departments of Anesthesia and Pediatrics, HarvardMedical School, Boston.

Address for correspondence: James E. Lock, M.D., Department ofCardiology, Children's Hospital, 300 Longwood Ave., Boston, MA02115.

Received Dec. 14, 1987; accepted Feb. 4, 1988.Dr. Lock is an Established Investigator of the American Heart Asso-

ciation.

Methods

Preliminary studies. Based on initial animal studies,6 our

first 12 procedures in children were performed transvenously onan inpatient basis. Informed consent was obtained from thepatient and /or the patient's parents. The FDA protocol fortranscatheter closure of PDA was approved by the Committeeof Clinical Investigation at the Children's Hospital. We used our

standard sedation technique of premedication with a meperidinecompound (Breon Laboratories), local anesthetic, and supple-mental sedation (morphine, diazepam) as needed. Patients weregiven heparin (100 units/kg) intravenously, several sets ofhemodynamic data were obtained, multiple aortograms were

performed with large arterial catheters to determine ductal anat-omy, and ductal closure was then attempted by a modifiedtransvenous long-sheath approach.6

These initial procedures were lengthy (3 to 4 hr total duration)and the success rate (67%) was similar to that previouslyreported. Ductal closure was only partial in two of the 12patients, due perhaps to increased PDA flow and/or systemicanticoagulation. Patient restlessness, incomplete sedation, andsnaring of the umbrella foam by the guidewire in another twochildren resulted in embolization of the umbrella device into theleft pulmonary artery. Retrieval of the device in these twopatients was accomplished uneventfully at the time of surgicalligation of the PDA. Based on our animal studies and theseinitial clinical experiences, we modified our technique in thefollowing ways: (1) The diagnosis and PDA anatomy wereestablished before catheterization. (2) The sedation/anestheticregimen was altered to meet the needs with respect to trans-catheter PDA closure rather than those of diagnostic cardiaccatheterization. (3) Systemic anticoagulation was avoided. (4)A strategy for management of pin entrapment in the foam was

devised. (5) Residual trans-PDA flow after umbrella placementwas temporarily occluded with balloon-tipped catheters. Thesemodifications were then used in 23 consecutive patients withuncomplicated PDA.

Procedure. All children over 6 kg with an apparent PDAunderwent complete examination and Doppler echocardiogra-phy as outpatients. Those with an isolated, restrictive (i.e.,without pulmonary hypertension) PDA of less than 10 mm indiameter and in the typical location were offered either surgicalligation or transvascular closure in the cardiac catheterization

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laboratory on an outpatient basis. One child with a nonrestrictivePDA and pulmonary vascular disease was hospitalized beforeand after a combined diagnostic and interventional catheteri-zation (successful) for assessment of pulmonary resistance.Twenty-three patients opted for outpatient transcatheter closure;they were examined in the cardiac clinic the day before closure.Ductal anatomy was assessed with two-dimensional, Doppler,and color flow echocardiography.The patients reported to ambulatory surgery the next morning,

where they were premedicated with morphine (0.1 to 0.2 mg/kgiv or im). After transfer to the catheterization laboratory, thegroin was prepared and infiltrated with local anesthetic. Thefemoral vein was cannulated with a 7F sheath, and the artery wascannulated with a No. 4F (patient less than 20 kg) or No. 5Fultrathin-walled Teflon pigtail catheter.7 Catheters were flushedwith heparinized saline, but heparin was not administered. Rightand left heart catheterization were rapidly performed with thepatient awake, sedated, and breathing room air spontaneously.Care was taken to leave the arterial catheter in the descendingaorta whenever possible. The precise size, configuration, andlocation of the PDA were determined via a retrograde aorto-gram. Catheter manipulation in the duct (and consequent ductalspasm) was avoided before aortography. A No. 7F balloon andend-hole catheter and/or 0.038 straight guidewire were thenadvanced from the main pulmonary artery across the PDA intothe aorta. The patient was then anesthetized with intravenousketamine and the catheter was removed over a 260 cm long,0.038 inch guidewire and the groin was predilated with a dilatorone French size larger than the long sheath. The Rashkind PDAoccluder with either the knuckle/eye or pin/pin mechanism wasused for PDA occlusion (USCI, Billerica, MA). For small PDAs(3 mm or less), a No. 8F long sheath and the 12 mm umbrellawere used; for larger PDAs (4 to 10 mm) we used a No. 11iF longsheath and the 17 mm umbrella. The curve on the long sheathswas partially straightened to about 90 degrees with use of steam.

The sheath and dilator were advanced across the PDA overthe guidewire into the aorta. The precise PDA position was againconfirmed after an injection of contrast by hand through the longsheath or pigtail; we have found that transvenous placement ofa long sheath through the PDA can distort the ductal positionas much as 5 to 8 mm. The patient was then anesthetized (1mg/kg iv ketamine). After soaking the umbrella foam disks intopical thrombin for 5 to 10 min, the umbrella was loaded andadvanced to the end of the sheath as previously described.4 6 8With the center of the double umbrella held at the aortic end ofthe duct, the long sheath was withdrawn until only the distal armsopened fully in the periductal aorta. The entire system waswithdrawn until the distal arms flexed inward; the umbrellaposition was held constant and the sheath was withdrawn untilthe proximal arms opened (figure 1). The fully sprung (butunreleased) device was gently moved back and forth to confirmcorrect position, and then released. Any ensnarement of therelease wire in the foam disks was managed by pinning theumbrella with the long sheath against the pulmonary end of theduct, allowing the wire tip to be safely freed (figure 2). Imme-diately after release of the umbrella, a test aortogram wasperformed with the aortic pigtail catheter; if more than trivialductal shunting persisted, the delivery catheter was removed andreplaced with a No. 7F balloon end-hole catheter. This catheterwas advanced to the pulmonary end of the PDA, and the inflatedballoon was "pressed" against the umbrella for 10 to 15 min toreduce flow and promote PDA thrombosis (figure 3).

After emergence from anesthesia each patient was admittedto the recovery area. A chest x-ray was obtained 4 hr later toconfirm device position. The puncture sites, pulses, and vitalsigns were monitored routinely, and children were discharged thesame day when awake, alert, drinking fluids, and ambulating

FIGURE 1. A, Lateral view of aortogram from a 1-year-old patientdemonstrating patency of the PDA (arrow) and filling of the pulmonaryartery with contrast. B, Same patient with double umbrella occluder inplace in the ductus, and long sheath and delivery device visible in thepulmonary artery. C, Repeat aortogram showing occlusion of the ductus.

appropriately for age. Each patient was examined at a follow-up(1 to 6 months).

ResultsWe attempted 23 consecutive outpatient procedures

(April 1986 to August 1987) in children ranging from1 to 15 years of age (table 1). As judged by absenceof a PDA murmur on discharge and a 1 to 6 monthsfollow-up, closure was successful in each child.

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WESSEL et a.

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3 4

FIGURE 2. After release of the guidewire, the wire tip springs cepha-lad and becomes snared in the foam (panel 2). The long sheath isadvanced over the wire, pinning the device against the pulmonary endof the duct (panel 3). The guidewire can now be safely withdrawnwithout dislodging the umbrella.

Technical observations. Only one umbrella was re-quired to close the PDA in 21 of 23 patients; in twopatients the initial expansion of the distal arms occurredin the pulmonary end of the PDA (due to unrecognizedposterior displacement of the PDA by the sheath, seeabove). In each, the umbrella was retrieved withoutcomplication, although in one patient the umbrellabecame lodged in the groin fascia during retrieval,requiring a small (1 cm) local incision. Closure was

FIGURE 3. Aortogram obtained immediately after umbrella release

demonstrates persistent left-to-right shunting. A balloon-tipped catheter

(arrow) is positioned to tamponade the ductus, perhaps contributing to

ductal closure 15 min later.

1070

TABLE 1Characteristics of patients undergoing transvenous PDA closure

Patient Age Weight Compli-No. (years) (kg) Success cation

1 4 14 Yes Pulse2 6 10 Yes None3 3 13 Yes None4 7 22 Yes None5 7 26 Yes None6 1 10 Yes None7 1 8 Yes None8 15 55 Yes None9 12 33 Yes None

10 6 24 Yes None11 8 33 Yes None12 3 15 Yes Cutdown13 1 9 Yes None14 2 12 Partial None15 1 11 Yes Pulse16 5 14 Yes None17 1 7 Yes None18 2 11 Yes None19 3 17 Yes None20 2 13 Yes None21 2 10 Yes None22 7 15 Yes None23 4 13 Yes None

Pulse transient loss of pedal pulse.

then achieved in both patients with use of a secondumbrella.

In two children the wire snared in the foam afterrelease; in each, the tip was easily dislodged by firstpinning the umbrella against the pulmonary artery (seefigure 2).

Angiographic observations. Aortography (1 ml/kg)performed at the end of the procedure confirmed com-plete PDA occlusion in 15 of 23 cases. In seven chil-dren, contrast sifted through the superior part of thedevice into the main pulmonary artery, although con-trast was not visible in the branch pulmonary arteries.In one child (with a large, 7 mm PDA) contrast couldbe seen in the main pulmonary artery, and faintly in theright and left; at the 1 month follow-up, there was noclinical evidence of a PDA.

Clinical, anesthetic observations. The average proce-dure duration was 95 min from initial hemodynamicsample to catheter removal. Follow-up chest x-rayswere unremarkable and showed no migration of thedevice or other complicating features.

Nineteen of the 23 patients were discharged homelater during the day of the procedure and did not requirehospital admission. Two patients remained in the hos-pital overnight for social reasons unrelated to the pro-

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THERAPY AND PREVENTION-CONGENITAL HEART DISEASE

cedure. A diminished pedal pulse several hours afterthe procedure necessitated intravenous heparin therapyovernight in another two patients, but both were dis-charged the following morning with normal lowerextremity pulses.The amount of ketamine required for anesthesia

ranged from 1.5 to 5 mg/kg. Small supplemental dosesof diazepam were administered in three older patientsto aid in emergence from ketamine, but no emergencedelirium was observed. Transient vomiting after theprocedure occurred in five patients, but protracted vom-iting was not observed and did not prevent dischargein any patient.

DiscussionThe surgical ligation of the PDA is safe, effective,

and requires about 1 week of hospitalization. Trans-catheter plug closure, a technique confined largely tothe older child or adult, has enjoyed considerable suc-cess2; of interest, late follow-up of 208 patients sotreated has revealed no episodes of endocarditis.9 Al-though the experience to date is limited, the techniqueof transvascular Rashkind umbrella closure of the PDAappears promising. Initial concerns about late migra-tion of umbrella devices have proven unfounded. In thecurrent literature, imprecision in device delivery, wiresnagging in the foam, and incomplete closure have re-sulted in clinical success (i.e., absence of typical mur-murs) rates of 65% to 85%.3-5 This relatively low suc-cess rate when compared with surgical closure hasinhibited enthusiasm for widespread use of this tech-nique.The purpose of this article is to describe several

technical modifications in method of placement of theRashkind PDA occluder and the results of use of thismodified technique. These changes include an anes-thetic regimen designed to facilitate outpatient PDAclosure, the use of small-bore retrograde arterial cath-eters to allow frequent angiographic assessment ofductal position (especially after placement of the longtransvenous sheath after initial placement of the um-brella) and patency, the avoidance of systemic anti-coagulation, the use of the long sheath to "pin" theumbrella against the pulmonary artery to reverse wireensnarement, the soaking of the umbrella foam in top-ical thrombin before loading, and the use of an inflatedballoon to "tamponade" residual PDA flow and pro-mote its closure. These modifications have, we believe,contributed to clinically successful transcatheter PDAclosure in 23 consecutive children with restrictive PDAs.

This report also serves to illustrate the degree to

which cardiac care can be streamlined as a result ofplanning and advancing technology. The diagnosis inthese children was established with considerable accu-racy, noninvasively, at the time of outpatient evalua-tion. Selection procedures were used at the time toidentify patients who required minimal invasive diag-nostic study. Techniques were designed to obviate theneed for systemic anticoagulation or large arterial cath-eters, thus reducing the potential for vascular trauma oflate complications. Preliminary studies indicated thatonly a brief period of patient immobility was neededand an anesthetic regimen was constructed that pro-duced the required control, minimal late morbidity, andexcellent short-term recovery. The use of morphinepremedication and ketamine anesthesia providedexcellent analgesia and amnesia, although the potentialfor airway compromise, as in any anesthetized patient,and the technical demands on the cardiologists duringthe procedure itself dictated careful attention by a pedi-atric anesthesiologist.The successful surgical ligation of a PDA introduced

a therapy that would remain the standard for 59 years.This same lesion was the first cardiac defect to be closedby transcatheter techniques. As a result of both advanc-ing technology and limited health care resources, aprocedure has been developed that can correct the samecardiac lesion on an outpatient basis. Although in-creased use of outpatient PDA closure may be antic-ipated because of these improved short-term results,the ultimate utility of this technique will be determinedafter long-term study of rates of late recanalization andendocarditis.

References1. Gross RE, Hubbard JP: Surgical ligation of a patent ductus arteriosus:

report of first successful case. JAMA 112: 729, 19392. Porstmann W, Wierny L, Warnke H, Gerstberger G, Romaniuk PA:

Catheter closure of patent ductus arteriosus, 62 cases treated withoutthoracotorny. Radiol Clin North Atn 9: 203, 1971

3. Rashkind WJ, Cuaso CC: Transcatheter closure of patent ductusarteriosus. Pediatr Cardiol 1: 3, 1979

4. Bash SE, Mullins CE: Insertion of patent ductus arteriosus occluderby transvenous approach: a new technique. Circulation 70(suppl II):11-285, 1985

5. Rashkind WJ, Mullins CE, Hellenbrand WE, Tait MA: Nonsurgicalclosure of patent ductus arteriosus: clinical application of the Rash-kind PDA occluder system. Circulation 75: 583, 1987

6. Lock JE, Bass JL, Lund G, Rysavy JA, Lucas RV Jr: Transcatheterclosure of patent ductus arteriosus in piglets. Am J Cardiol 55: 826,1985

7. Keane JF, Freed MD, Fellows KE, Fyler DC: Pediatric cardiacangiography usirig a 4 French catheter. Cathet Cardiovasc Diagn 3:313, 1977

8. Lock JE, Cockerham JT, Keane JF, Finley JP, Wakely PE, FellowsKE: Transcatheter umbrella closure of congenital cardiac defects.Circulation 75: 593, 1987

9. Wierny L, Plass R, Porstmann W: Transluminal closure of patentductus arteriosus: long-term results of 208 cases treated with tho-racotomy. Cardiovasc Intervent Radiol 9: 279, 1986

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D L Wessel, J F Keane, I Parness and J E LockOutpatient closure of the patent ductus arteriosus.

Print ISSN: 0009-7322. Online ISSN: 1524-4539 Copyright © 1988 American Heart Association, Inc. All rights reserved.

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