Catheterization and Cardiovascular Interventions 00:00–00 (2016)
Original Studies Results of Coil Closure of Patent Ductus Arteriosus Using a Tapered Tip Catheter for Enhanced Control Rajiv Devanagondi,1* MD, Larry Latson,2 MD, Sharon Bradley-Skelton,3 MSN, RN, and Lourdes Prieto,3 MD Objectives: This article describes the efficacy and embolization rates of coil delivery via modified vertebral catheter (MVC) for patent ductus arteriosus (PDA) closure. Background: Various techniques have been devised to enhance coil control and prevent embolization during PDA closure. Since 1995, they have delivered coils via tapered vertebral catheters for improved coil control. Methods: Catheterization reports, angiograms, and echocardiograms were reviewed for patients with PDA occlusion via MVC from 2001 to 2014. Residual shunting was determined by angiography and echocardiogram within 24 hr post-procedure. Procedural success was defined as trivial angiographic and echocardiographic shunt, and no aortic nor LPA obstruction, after final coil delivery. Results: About 125 coil occlusions were attempted in 103 patients. Minimal PDA diameter was 2 (0.6–6) mm. Four coils were removed with a snare/bioptome due to aortic/LPA obstruction following release. Seven were malpositioned while still held by the MVC of which three embolized while attempting withdrawal. Five embolized after full release from the MVC. The embolization rate was 6.4%. Embolizations were more likely in PDAs 2.5 mm (P < 0.05). Ultimately, 98/103 PDAs were occluded using the MVC. No patient had greater trivial residual shunt or aortic/LPA obstruction for an overall success rate of 95%. For PDAs < 2.5 mm the success rate was 97%. Conclusions: Coil delivery via MVC was safe and effective for small PDAs. While fully controlled release and retrieval devices are now available for PDA closure with lower embolization rates, coil occlusion by MVC should still be considered for small PDAs, especially in resource limited regions. VC 2016 Wiley Periodicals, Inc. Key words: PDA; coil occlusion; embolization
INTRODUCTION
Transcatheter closure of the patent ductus arteriosus (PDA) has evolved substantially since the original procedure by Portsmann et al. in 1967 [1]. His report described percutaneous PDA closure using an Ivalon plug and ushered in the era of implantable transcatheter devices for congenital heart disease treatment. Twentyfive years later, Cambier et al. described the use of embolization coils, originally designed for peripheral vascular occlusion, to close PDAs [2]. While the efficacy of PDA coil occlusion was demonstrated, lack of coil control once any portion of the coil was extruded is a limitation of the original deployment technique. In 1995, we began using heat tapered 5 Fr vertebral catheters (Mallinckrodt, Inc., St. Louis, MO) for coil mediated PDA closure with enhanced control [3]. C 2016 Wiley Periodicals, Inc. V
1
Division of Pediatric Cardiology, Golisano Children’s Hospital, University of Rochester Medical Center, Rochester, New York 2 Heart Center, , Joe DiMaggio Children’s Hospital, Hollywood, Florida 3 Center for Pediatric and Congenital Heart Disease, Cleveland Clinic Foundation, Cleveland, Ohio Conflict of interest: Nothing to report. *Correspondence to: Rajiv Devanagondi, MD; University of Rochester Medical Center, 601 Elmwood Ave., Box 631, Rochester, NY 14642. E-mail: [email protected] Received 12 August 2015; Revision accepted 26 December 2015 DOI: 10.1002/ccd.26415 Published online 00 Month 2016 in Wiley Online Library (wileyonlinelibrary.com)
2
Devanagondi et al.
We report our results using the tapered tip modified vertebral catheter (MVC) for coil control during PDA closure in a large cohort of patients. MATERIALS AND METHODS
Catheterization reports, angiograms, and echocardiograms were retrospectively reviewed for all patients with PDA occlusion using the MVC from 2001 to 2014. The study protocol was approved, and a waiver for informed consent was granted, by the Institutional Review Board at our institution. PDA morphology was categorized according to Krichenko’s criteria by angiography [4]. The ductal length and minimum PDA diameter were measured from the lateral projection angiogram. Residual shunt immediately post coil deployment was determined by angiography. Residual shunt was defined as: trivial—any residual contrast in the main pulmonary artery without a distinct jet; mild—a distinct jet through the PDA, which did not reach the pulmonary valve; moderate—a distinct jet through the PDA, which reached the level of the pulmonary valve; and severe—a broad jet of contrast through the PDA, with contrast opacification of the main and branch pulmonary arteries, and visible pulmonary venous return. Post-procedure shunt was evaluated by color Doppler echocardiogram within 24 hr post-catheterization. Procedural success was defined as PDA closure by coil delivery via MVC with no aortic nor LPA obstruction after final coil delivery and less than or equal to trivial angiographic and color Doppler residual shunt by echocardiogram. Procedural Details
Patients were systemically heparinized after vascular access was obtained, and intravenous cefazolin was administered prior to coil delivery. Vertebral catheters were initially modified for each procedure using a heat gun to taper the catheter tip until a 0.03500 guidewire would snugly fit through it [3,5]. The catheters were subsequently manufactured pre-tapered for coil delivery by Mallinckrodt and Cook (Cook, Inc., Bloomington, IN), and are currently manufactured by Merit (Merit Medical Systems, Inc., South Jordan, UT). The tapered catheter tip enables delivery of 0.03800 Gianturco or MReye coils (Cook, Inc., Bloomington, IN) with enough friction to allow for controlled delivery if at least 2 mm remains within the catheter tip. As there was mild variability in manufacturing tolerances from catheter to catheter, we routinely tested each catheter on the table by advancing a 0.03500 straight wire through the catheter tip to ensure there was sufficient resistance.
The gripping force is generally sufficient for the partially deployed coil to carefully be completely withdrawn into a 5 or 6 Fr sheath without release from the catheter tip. The MVC was typically advanced through a 5 Fr femoral venous sheath. For patients with large PDAs and presumed increased risk for embolization, the MVC was advanced through a 6 Fr Mullins sheath positioned in the main pulmonary artery. This allows the partially delivered coil to be removed if necessary while eliminating the risk of coil ensnarement on intracardiac structures during withdrawal. In our series, the standard approach was to deliver coils prograde when possible. In some cases, if the ductus could not be crossed prograde, a wire was advanced retrograde and snared in the main pulmonary artery to establish a venoarterial rail to facilitate advancing the MVC prograde across the ductus. In some cases in which the prograde approach was difficult, the MVC was advanced retrograde across the ductus for coil delivery. Coil diameter was approximately twice the narrowest diameter of the PDA. Coils were advanced through the MVC using the soft end of a 0.03500 guidewire. For the prograde approach, all but one loop was extruded in the proximal descending aorta. Although there was pulsatile movement of the extruded portion the coil, still held securely by the tapered catheter, was then pulled back into the ampulla, and the final loop was deployed on the pulmonary arterial side of the ductus (Fig. 1). For the retrograde approach, one loop was deployed in the pulmonary artery, and the remainder of the coil was deployed in the descending aorta. In the early phase of this experience (when specific PDA closure devices were not approved for use in the United States), additional coils were delivered as needed for significant residual shunts. Earlier in the series, protamine was administered to reverse heparin at the discretion of the interventional cardiologist. Statistical Analysis
Continuous variables were reported as median (range). Categorical variables were reported as n (%). Odds ratios were calculated and 95% confidence intervals obtained by logistic regression for risk of embolization with minimum PDA diameter 2.5. Association between PDA/coil characteristics and embolization were determined by Chi-square analysis. A P-value
Original Studies Results of Coil Closure of Patent Ductus Arteriosus Using a Tapered Tip Catheter for Enhanced Control Rajiv Devanagondi,1* MD, Larry Latson,2 MD, Sharon Bradley-Skelton,3 MSN, RN, and Lourdes Prieto,3 MD Objectives: This article describes the efficacy and embolization rates of coil delivery via modified vertebral catheter (MVC) for patent ductus arteriosus (PDA) closure. Background: Various techniques have been devised to enhance coil control and prevent embolization during PDA closure. Since 1995, they have delivered coils via tapered vertebral catheters for improved coil control. Methods: Catheterization reports, angiograms, and echocardiograms were reviewed for patients with PDA occlusion via MVC from 2001 to 2014. Residual shunting was determined by angiography and echocardiogram within 24 hr post-procedure. Procedural success was defined as trivial angiographic and echocardiographic shunt, and no aortic nor LPA obstruction, after final coil delivery. Results: About 125 coil occlusions were attempted in 103 patients. Minimal PDA diameter was 2 (0.6–6) mm. Four coils were removed with a snare/bioptome due to aortic/LPA obstruction following release. Seven were malpositioned while still held by the MVC of which three embolized while attempting withdrawal. Five embolized after full release from the MVC. The embolization rate was 6.4%. Embolizations were more likely in PDAs 2.5 mm (P < 0.05). Ultimately, 98/103 PDAs were occluded using the MVC. No patient had greater trivial residual shunt or aortic/LPA obstruction for an overall success rate of 95%. For PDAs < 2.5 mm the success rate was 97%. Conclusions: Coil delivery via MVC was safe and effective for small PDAs. While fully controlled release and retrieval devices are now available for PDA closure with lower embolization rates, coil occlusion by MVC should still be considered for small PDAs, especially in resource limited regions. VC 2016 Wiley Periodicals, Inc. Key words: PDA; coil occlusion; embolization
INTRODUCTION
Transcatheter closure of the patent ductus arteriosus (PDA) has evolved substantially since the original procedure by Portsmann et al. in 1967 [1]. His report described percutaneous PDA closure using an Ivalon plug and ushered in the era of implantable transcatheter devices for congenital heart disease treatment. Twentyfive years later, Cambier et al. described the use of embolization coils, originally designed for peripheral vascular occlusion, to close PDAs [2]. While the efficacy of PDA coil occlusion was demonstrated, lack of coil control once any portion of the coil was extruded is a limitation of the original deployment technique. In 1995, we began using heat tapered 5 Fr vertebral catheters (Mallinckrodt, Inc., St. Louis, MO) for coil mediated PDA closure with enhanced control [3]. C 2016 Wiley Periodicals, Inc. V
1
Division of Pediatric Cardiology, Golisano Children’s Hospital, University of Rochester Medical Center, Rochester, New York 2 Heart Center, , Joe DiMaggio Children’s Hospital, Hollywood, Florida 3 Center for Pediatric and Congenital Heart Disease, Cleveland Clinic Foundation, Cleveland, Ohio Conflict of interest: Nothing to report. *Correspondence to: Rajiv Devanagondi, MD; University of Rochester Medical Center, 601 Elmwood Ave., Box 631, Rochester, NY 14642. E-mail: [email protected] Received 12 August 2015; Revision accepted 26 December 2015 DOI: 10.1002/ccd.26415 Published online 00 Month 2016 in Wiley Online Library (wileyonlinelibrary.com)
2
Devanagondi et al.
We report our results using the tapered tip modified vertebral catheter (MVC) for coil control during PDA closure in a large cohort of patients. MATERIALS AND METHODS
Catheterization reports, angiograms, and echocardiograms were retrospectively reviewed for all patients with PDA occlusion using the MVC from 2001 to 2014. The study protocol was approved, and a waiver for informed consent was granted, by the Institutional Review Board at our institution. PDA morphology was categorized according to Krichenko’s criteria by angiography [4]. The ductal length and minimum PDA diameter were measured from the lateral projection angiogram. Residual shunt immediately post coil deployment was determined by angiography. Residual shunt was defined as: trivial—any residual contrast in the main pulmonary artery without a distinct jet; mild—a distinct jet through the PDA, which did not reach the pulmonary valve; moderate—a distinct jet through the PDA, which reached the level of the pulmonary valve; and severe—a broad jet of contrast through the PDA, with contrast opacification of the main and branch pulmonary arteries, and visible pulmonary venous return. Post-procedure shunt was evaluated by color Doppler echocardiogram within 24 hr post-catheterization. Procedural success was defined as PDA closure by coil delivery via MVC with no aortic nor LPA obstruction after final coil delivery and less than or equal to trivial angiographic and color Doppler residual shunt by echocardiogram. Procedural Details
Patients were systemically heparinized after vascular access was obtained, and intravenous cefazolin was administered prior to coil delivery. Vertebral catheters were initially modified for each procedure using a heat gun to taper the catheter tip until a 0.03500 guidewire would snugly fit through it [3,5]. The catheters were subsequently manufactured pre-tapered for coil delivery by Mallinckrodt and Cook (Cook, Inc., Bloomington, IN), and are currently manufactured by Merit (Merit Medical Systems, Inc., South Jordan, UT). The tapered catheter tip enables delivery of 0.03800 Gianturco or MReye coils (Cook, Inc., Bloomington, IN) with enough friction to allow for controlled delivery if at least 2 mm remains within the catheter tip. As there was mild variability in manufacturing tolerances from catheter to catheter, we routinely tested each catheter on the table by advancing a 0.03500 straight wire through the catheter tip to ensure there was sufficient resistance.
The gripping force is generally sufficient for the partially deployed coil to carefully be completely withdrawn into a 5 or 6 Fr sheath without release from the catheter tip. The MVC was typically advanced through a 5 Fr femoral venous sheath. For patients with large PDAs and presumed increased risk for embolization, the MVC was advanced through a 6 Fr Mullins sheath positioned in the main pulmonary artery. This allows the partially delivered coil to be removed if necessary while eliminating the risk of coil ensnarement on intracardiac structures during withdrawal. In our series, the standard approach was to deliver coils prograde when possible. In some cases, if the ductus could not be crossed prograde, a wire was advanced retrograde and snared in the main pulmonary artery to establish a venoarterial rail to facilitate advancing the MVC prograde across the ductus. In some cases in which the prograde approach was difficult, the MVC was advanced retrograde across the ductus for coil delivery. Coil diameter was approximately twice the narrowest diameter of the PDA. Coils were advanced through the MVC using the soft end of a 0.03500 guidewire. For the prograde approach, all but one loop was extruded in the proximal descending aorta. Although there was pulsatile movement of the extruded portion the coil, still held securely by the tapered catheter, was then pulled back into the ampulla, and the final loop was deployed on the pulmonary arterial side of the ductus (Fig. 1). For the retrograde approach, one loop was deployed in the pulmonary artery, and the remainder of the coil was deployed in the descending aorta. In the early phase of this experience (when specific PDA closure devices were not approved for use in the United States), additional coils were delivered as needed for significant residual shunts. Earlier in the series, protamine was administered to reverse heparin at the discretion of the interventional cardiologist. Statistical Analysis
Continuous variables were reported as median (range). Categorical variables were reported as n (%). Odds ratios were calculated and 95% confidence intervals obtained by logistic regression for risk of embolization with minimum PDA diameter 2.5. Association between PDA/coil characteristics and embolization were determined by Chi-square analysis. A P-value
