April

Incidence and fate of device-related left pulmonary artery stenosis and aortic coarctation in small infants undergoing transcatheter patent ductus arteriosus closure. Tomasulo CE, Gillespie MJ, Munson D, Demkin T, O'Byrne ML, Dori Y, Smith CL, Rome JJ, Glatz AC. Catheter Cardiovasc Interv. 2020 Apr 27. doi: 10.1002/ccd.28942. [Epub ahead of print] PMID: 32339400 Similar articles Select item 32338402     Take Home Points: Transcatheter PDA closure is the preferred treatment option for nearly all patients with PDAs, even those near 1 kg, at most centers LPA stenosis and aortic coarctation are known risk factors in infants undergoing PDA closure This study supports that the majority of LPA and aortic obstruction tend to improve over time Commentary from Dr. Ryan Romans (Kansas City, MO), section editor of Congenital Heart Disease Interventions Journal Watch:   Transcatheter PDA closure (TC-PDA) is at least as safe and as efficacious as surgical ligation and offers a lower morbidity option. It has long been the standard for larger infants, children, and adults. The number of available devices that are able to be delivered through small sheaths has led to improved outcomes in TC-PDA and allowed for closure in smaller infants who were previously routinely referred for surgical PDA ligation. Left pulmonary artery (LPA) stenosis and aortic coarctation are known concerns in this patient population and are well described. However, longer term outcomes of these complications are not known. Tomasulo et al. report on a retrospective analysis of all infants ≤ 4 kg who underwent TC-PDA from 2007-2018. A total of 44 infants met inclusion criteria and had successful TC-PDA. The median weight was 2.8 kg (range 1.2-4 kg), with a trend towards lower weights later in the study time frame (6/10 from 2018 weighed <2 kg). The majority of patients (30/44) underwent PDA closure with an Amplatzer Vascular Plug II (AVP-II), 10 with an Amplatzer Duct Occluder II-Additional sizes (ADOII-AS, now known as the Piccolo device), 3 with an Amplatzer Duct Occluder I (ADO1), and 1 with an Amplatzer Vascular Plug I filled with 3 Cook embolization coils. The devices were placed via an antegrade approach from the femoral vein in all patients. Arterial access was obtained in 59% of patients, though in only 3/17 patients since 2017 (and none who had an ADOII-AS device placed). Type F (61%) and Type C (23%) PDAs made up the large majority of cases. Of the 44 patients, 39 had post procedure echocardiograms performed, all of which showed complete closure of the PDA. Angiography showed mild or less residual shunt in the other 5. Median follow up was 0.7 years (range 2 days-7 years) with 38 patients having assessment for LPA stenosis and aortic coarctation. Of these 38 patients, 21 patients (55%) had obstruction in at least 1 vessel. A total of 17 patients had mild flow acceleration (defined as an echocardiographic flow velocity of 1.5-2 m/sec) or stenosis (flow velocity >2 m/sec) in the LPA (though 3 of these already had flow acceleration/stenosis on their pre procedure echocardiogram). The majority of these improved as shown below. Those who developed LPA obstruction were younger, had larger PDAs, and were less likely to have an AVP II device placed. A total of 4 patients developed flow acceleration in the aorta (flow velocity 1.5-2 m/sec) and 3 developed mild aortic coarctation (flow velocity >2 m/sec). Of these, 4/7 had improved at the time of last follow up as detailed below. Lower birth weight was the only statistically significant factor associated with aortic obstruction, though there was a trend towards later gestational age and shorter PDAs. This study confirms that LPA and aortic obstruction are frequently seen in TC-PDA in small infants. However, the amount of obstruction seen is typically quite mild and likely clinically irrelevant. Additionally, most of the obstruction improves over time and none of the patients in this cohort required additional intervention (though other studies on TC-PDA closure in small infants have shown a small number requiring intervention). While this study adds reassuring information to the literature, the types of devices being used in this population is changing. The Piccolo device now has FDA approval for TC-PDA in this patient population and is now most interventionalists go to device. Additionally, the MVP microvascular plug (Medtronic) has frequently been used for TC-PDA closure in small infants and is not reported on in this study. Future studies are warranted to evaluate these known problems with the devices that are more frequently used today.    

Here today, gone tomorrow: Outcomes of residual leak following secundum atrial septal defect closure with the GORE CARDIOFORM Septal Occluder. Gordon BM, Abudayyeh I, Goble J, Collado NA, Paolillo J.Catheter Cardiovasc Interv. 2020 Apr 1;95(5):932-936. doi: 10.1002/ccd.28666. Epub 2019 Dec 26.PMID: 31876383 Take Home Points: Residual leaks following device closure of secundum atrial septal defects, particularly when using the GORE CARDIOFORM Septal Occluder, are poorly understood. Patients with larger defects, smaller aortic rims, and with the presence of multiple fenestrations are more likely to have residual leaks following ASD device closure with the GSO. Residual leaks following ASD device closure with the GSO frequently disappear within the first year following implantation. Commentary from Dr. Arash  Salavitabar (Ann Arbor, MI), section editor of Congenital Heart Disease Interventions Journal Watch:  In this retrospective, multicenter study, the authors aimed to review experiences with outcomes of residual leaks following device closure of secundum atrial septal defects (ASD) with the GORE CARDIOFORM Septal Occluder (GSO) during the pivotal and continued access study. This is a well-known potential issue post-device closure of ASDs and the expectant course is not well-described, particularly with this device. One important characteristic of the GSO device is that it is not “self-centering”, and so it has the ability to shift as it conforms to the septal anatomy. This can lead to potential small leaks around the edge of the device. The authors sought to characterize the medium-term outcomes of residual leaks noted with the GSO and to report on potential risk factors associated with eventual closure rates.   This study included 69 patients who had a residual leak following device implantation, out of 374 total patients who underwent ASD closure with the GSO for the pivotal and continued access U.S. trials. Sixty-five (17.5%) patients met inclusion criteria following retrospective review of their echocardiograms. When comparing those with and without residual leak, those with residual leaks had larger defects (10.33 ± 3.05 mm vs. 9.13 ± 2.89 mm, p = .006), larger stop flow balloon sizes (12.91 ± 3.02 mm vs. 11.43 ± 2.89 mm, p < .001), smaller aortic rims (4.87 ± 3.33 mm vs. 6.17 ± 3.78 mm, p = .019), the presence of multiple fenestrations (43.08% vs. 18.69%, p < .001), and increased fluoroscopic time (16.02 ± 9.65 min vs. 13.17 ± 9.03 min, p = .004). Larger devices tended to be implanted and more devices per case were utilized in the residual leak cohort as compared to those without leak. There was no significant differences between procedural time, device- to-defect ratio, or type of anesthesia among groups. Importantly, there was a significant decrease in the leak size over 1 year in those patients with residual leak, from 1.55 ± 0.75mm to 0.25 ± 0.74mm (p < 0.001), with the majority disappearing by that 1 year follow-up (Figure 1). The authors postulate that residual shunts adjacent to ASD closure devices disappear over time due to remodeling of the right atrium with subsequent normalization of right atrial size following removal of the volume load caused by the ASD. This is thought to augment the endothelialization that occurs from adjacent tissue. While this study is limited by its retrospective nature, it provides important information regarding risk factors for residual leak following ASD device closure, particularly with the GSO. It is also valuable to understand that these residual leaks frequently completely disappear over the first year following implantation, which can affect patient counseling, frequency of follow-up, and potential need for future interventions.    

Gordon BM, Abudayyeh I, Goble J, Collado NA, Paolillo J.Catheter Cardiovasc Interv. 2020 Apr 1;95(5):932-936. doi: 10.1002/ccd.28666. Epub 2019 Dec 26.PMID: 31876383 Take Home Points:   Residual leaks following device closure of secundum atrial septal defects, particularly when using the GORE CARDIOFORM Septal Occluder, are poorly understood. Patients with larger defects, smaller aortic rims, and with the presence of multiple fenestrations are more likely to have residual leaks following ASD device closure with the GSO. Residual leaks following ASD device closure with the GSO frequently disappear within the first year following implantation.     Commentary from Dr. Arash  Salavitabar (Ann Arbor, MI), section editor of Congenital Heart Disease Interventions Journal Watch:  In this retrospective, multicenter study, the authors aimed to review experiences with outcomes of residual leaks following device closure of secundum atrial septal defects (ASD) with the GORE CARDIOFORM Septal Occluder (GSO) during the pivotal and continued access study. This is a well-known potential issue post-device closure of ASDs and the expectant course is not well-described, particularly with this device. One important characteristic of the GSO device is that it is not “self-centering”, and so it has the ability to shift as it conforms to the septal anatomy. This can lead to potential small leaks around the edge of the device. The authors sought to characterize the medium-term outcomes of residual leaks noted with the GSO and to report on potential risk factors associated with eventual closure rates.   This study included 69 patients who had a residual leak following device implantation, out of 374 total patients who underwent ASD closure with the GSO for the pivotal and continued access U.S. trials. Sixty-five (17.5%) patients met inclusion criteria following retrospective review of their echocardiograms. When comparing those with and without residual leak, those with residual leaks had larger defects (10.33 ± 3.05 mm vs. 9.13 ± 2.89 mm, p = .006), larger stop flow balloon sizes (12.91 ± 3.02 mm vs. 11.43 ± 2.89 mm, p < .001), smaller aortic rims (4.87 ± 3.33 mm vs. 6.17 ± 3.78 mm, p = .019), the presence of multiple fenestrations (43.08% vs. 18.69%, p < .001), and increased fluoroscopic time (16.02 ± 9.65 min vs. 13.17 ± 9.03 min, p = .004). Larger devices tended to be implanted and more devices per case were utilized in the residual leak cohort as compared to those without leak. There was no significant differences between procedural time, device- to-defect ratio, or type of anesthesia among groups.   Importantly, there was a significant decrease in the leak size over 1 year in those patients with residual leak, from 1.55 ± 0.75mm to 0.25 ± 0.74mm (p < 0.001), with the majority disappearing by that 1 year follow-up (Figure 1).   The authors postulate that residual shunts adjacent to ASD closure devices disappear over time due to remodeling of the right atrium with subsequent normalization of right atrial size following removal of the volume load caused by the ASD. This is thought to augment the endothelialization that occurs from adjacent tissue.   While this study is limited by its retrospective nature, it provides important information regarding risk factors for residual leak following ASD device closure, particularly with the GSO. It is also valuable to understand that these residual leaks frequently completely disappear over the first year following implantation, which can affect patient counseling, frequency of follow-up, and potential need for future interventions.