Congenital Heart Interventions

Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: One-Year Results of the CANOA Randomized Clinical Trial

Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: One-Year Results of the CANOA Randomized Clinical Trial View Article Wintzer-Wehekind J, Horlick E, Ibrahim R, Cheema AN, Labinaz M, Nadeem N, Osten M, Côté M, Marsal JR, Rivest D, Marrero A, Houde C, Rodés-Cabau J. JAMA Cardiol. 2020 Sep 23:e204297. doi: 10.1001/jamacardio.2020.4297. Online ahead of print. PMID: 32965476 Take Home Points: New-onset migraines after ASD closure improve or resolve spontaneously within 6 to 12 months in most patients. No significant rebound effect is observed after clopidogrel cessation at 3 months suggesting that early discontinuation should be strongly considered. Commentary from Dr. Konstantin Averin (Edmonton), catheterization section editor of Pediatric Cardiology Journal Watch:  Approximately 15% of patients develop new-onset migraine headaches after transcatheter closure of secundum atrial septal defects (ASD) with nitinol-based devices.  The Clopidogrel for the Prevention of New Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects (CANOA) trial demonstrated that these migraines can be successfully treated with clopidogrel within the 3-month period after device implant.  There are limited data on the longer-term outcomes of migraines related to ASD closure.  The authors sought to use the same patient cohort to assess late-incidence and severity of migraine attacks after ASD closure and clopidogrel cessation up to 12 months post-procedure. A total of 171 patients were included for analysis (84 – clopidogrel and 87 – placebo), of which 27 (15.8%) developed migraines in the first 3 months and 2 (1.2%) after the first 3 months (see Figure below).  At 3 months, there were significantly more patients with migraine in the placebo group (21.8% v 9.5%, p = 0.03).  Only 2 patients presented with new migraine headaches after 3 months (none after 6 months) and 6 had residual migraine at 6 months.  Beyond 3 months, there were no significant differences (placebo v clopidogrel) in number of patients with persistent migraine headaches and new migraine headaches after 3 months. The authors conclude that new-onset migraine headaches after ASD closure occurred early (within 3 months) and resolved or improved spontaneously within 6 to 12 months in most patients.  Given the bleeding risks associated with dual antiplatelet therapy (DAPT), especially in older populations, it is important to limit the duration of DAPT.  These data suggest that DAPT can be used successfully for 3 months post-ASD closure in patients who develop migraines.  Future research should focus on identification of patients at risk for developing migraines post-ASD closure and longer term outcomes of persistent migraines.

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Prelimisnary findings on the use of intravascular ultrasound in the assessment of pediatric pulmonary vein stenosis

Prelimisnary findings on the use of intravascular ultrasound in the assessment of pediatric pulmonary vein stenosis View Article Callahan R, Jenkins KJ, Gauthier Z, Gauvreau K, Porras D. Catheter Cardiovasc Interv. 2020 Sep 16. doi: 10.1002/ccd.29264. Online ahead of print. PMID: 32936535 Take Home Points: Intravascular ultrasound (IVUS) was able to be safely performed in patients undergoing catheterization for assessment of pulmonary vein stenosis. IVUS allowed for better characterization of pulmonary vein pathology with moderate inter-observer reproducibility. Commentary from Dr. Konstantin Averin (Edmonton), catheterization section editor of Pediatric Cardiology Journal Watch:  The etiology of pulmonary vein stenosis (PVS) in the pediatric population is heterogeneous and can be challenging to delineate via traditional angiography.  Intravascular ultrasound (IVUS) is additive in the assessment of adult venous pathology.  The use of IVUS in pediatric patients with PVS has not been previously reported.  The authors sought to describe their retrospective single center experience using IVUS in the assessment of pediatric patients with PVS. From August 1, 2016 to December 31, 2019 IVUS was performed in 81 pulmonary veins during 54 catheterizations in 50 patients (median age 1.7 yrs. [0.9-3.1], median weight 8.6 kgs [7.3, 11.8]).  Angiography and IVUS images were reviewed by 2 independent observers and IVUS images were categorized according to the schema below (Figure 1) – initially as adequately or inadequately imaged and then according to the presence of presumed intimal thickening (PIT).  Most pulmonary veins (88%) were adequately imaged, and the inadequately imaged veins were early in the centers experience.  About 50% had PIT, with the obstruction in the remaining veins being related to ostial stenosis or compression/distortion.  The authors provide several nice examples of IVUS imaging of the different pulmonary vein categories (Figure 2).  There was no obvious increase in adverse events during procedures where IVUS was used.  IVUS classifications were moderately reproducible - in patients with existing stents there was 100 inter-rater agreement with regard to presence or absence of in-stent stenosis, while in patients without stents there was somewhat less inter-rater reliability with a combined precent agreement of 75% and a k of 0.67. The authors nicely demonstrate that IVUS can be safely performed in this novel pediatric population.  However, as the authors acknowledge, this paper raises many more questions than it answers.  Further work should focus on whether this imaging modality will allow precise definition of pulmonary vein pathology, assist in tailoring treatment, and improve patient outcomes.  Given the complexity and high morbidity of pediatric PVS stenosis IVUS may play an important role in improving outcomes of this disease. FIGURE 1 Figure 2. Intravascular ultrasound of pulmonary veins contrasted with pulmonary vein pathology specimens (all four examples obtained from different patients); (a) IVUS image of normal pulmonary vein with a thin wall and circular lumen, (b) circumferential specimen of a normal pulmonary vein, (c) IVUS image of vein with presumed intimal thickening and luminal narrowing, (d) circumferential specimen of pulmonary vein with intraluminal pulmonary vein stenosis (neo-intimal proliferation).

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Acute and medium term results of balloon expandable stent placement in the transverse arch-a multicenter pediatric interventional cardiology early career society study

Acute and medium term results of balloon expandable stent placement in the transverse arch-a multicenter pediatric interventional cardiology early career society study View Article Shabana Shahanavaz 1, Osamah Aldoss 2, Kaitlin Carr 2, Brent Gordon 3, Michael D Seckeler 4, Gurumurthy Hiremath 5, Cameron Seaman 6, Jenny Zablah 7, Gareth Morgan 7 Catheter Cardiovasc Interv 2020 Sep 9. doi: 10.1002/ccd.29248. Online ahead of print. Affiliations expand PMID: 32902911; DOI: 10.1002/ccd.29248 Take Home Points: Transcatheter stenting of the transverse aortic arch (TAO) is feasible and with low incidence of major procedural complications. TAO stenting results in significant improvement in aortic arch gradient and narrowest arch diameter. TAO stenting in patients <10kg has an inherently high incidence of reinterventions and should only be used as a temporizing intervention to help achieve growth, recover ventricular function in a single ventricle, or resolution of other comorbidities. TAO stenting may benefit from 3D imaging of aortic arch obstruction to guide interventions. Commentary from Dr. Arash Salavitabar (Ann Arbor, USA), section editor of Congenital Heart Disease Interventions Journal Watch:   The authors addressed an important subgroup of patients, those with transverse aortic arch (TAO) obstruction, that often pose a difficult dilemma regarding whether transcatheter strategies can be utilized. This was a retrospective study from 7 centers from 7/2009 to 12/2017, designed to evaluate immediate and midterm results of TAO stent implantation. TAO stenting was defined as stent placement proximal to the third head and neck vessel with the primary intention of treating narrowing in the transverse aorta. This did not include patients in whom the stent simply traversed the left subclavian artery in the absence of distal arch narrowing. Fifty-seven subjects were included at a median age of 14 years (4 days-42 years). Recoarctation following surgical repair was seen in 79% of patients and previous catheter-based therapy in 11%. The site of maximal narrowing was the isthmus in 35%, proximal transverse arch in 33%, distal transverse arch in 28%, and ascending aorta in 4% of patients. Gothic arches were seen in 25% of patients. 3D rotational angiography was utilized in 35% of cases. Femoral arterial access was used in 90% of cases, femoral venous in 5%, and carotid cutdown in 5% (all <5kg). Stents used were predominantly EV3 LD (Medtronic Inc, Minneapolis) (72%), followed by Palmaz Genesis XD (Cordis Inc Santa Clara Ca) (16%) and premounted [Herculink (Abbott Vascular, Abbott Park, IL) or Valeo (Bard Inc, Tempe, AZ)] (12%). One or more arch branches were jailed by the stent in 55 (96%) patients: left SCA covered in 53 (93%), left common carotid artery in 15 (26%), an aberrant right SCA in 2 (4%) and in 2 (4%) patients with previous subclavian artery flap coarctation repairs there was partial coverage of the left common carotid artery. There were 11 patients (21%) who required balloon angioplasty of the side cells of the stents to maximize patency of vessel origins (7 left common carotid, 3 left subclavian artery). The decisions to perform these interventions were up to the discretion of the interventional cardiologist. There was significant improvement in transcatheter aortic arch gradient (p>0.001), narrowest arch diameter (p<0.001), and systolic BP pressure prior to discharge (p<0.001). There were 7 infants (all <6 months of age) at the time of intervention, 4 of which had recoarctation following a Norwood-type arch reconstruction. All of these patients had premounted stents placed. Surgical re-intervention was performed in 3 (43%) with surgical removal of stents and arch reconstruction. There were 3 (43%) mortalities: 2 with single ventricle physiology, one of which was after next staged surgical palliation and one due to worsening ventricular function, and one with native coarctation and genetic abnormalities. Patients with native coarctation were more likely to have smaller diameters of the ascending aorta, proximal transverse, and distal transverse arch. Patients with native coarctation were more likely to have a higher residual gradient post-intervention (p = .022). Complications included stent migration resulting in unintended jailing of the innominate artery in 2 patients (4%), hypotension warranting inotropic support in 2 patients (4%), pulse loss in 1 patient, and left arm brachial plexus injury in 1 patient. Over the median follow-up of 38 months (0.4-7.3 years), 5 subjects died (all unrelated to the procedure) and there was 1 unplanned and 7 planned reinterventions (6 catheterizations, 2 surgeries). The surgeries were performed in patients in whom initial stenting took place at <1 months of age with the purpose to delay surgery. Antihypertensive medications were used in 27 (47%) patients prior to arch intervention and were continued in 23 (40%) patients at final follow-up. There were no cerebrovascular events or reports of subclavian steal syndrome during follow-up. Of note, there was no routine use of advanced brain imaging before and/or after TAO stenting. The authors concluded that TAO stenting can be useful in select patients within minimal complications. However, systemic hypertension often continues to be an issue and requires medications despite resolution of TAO stenosis. As with all complex congenital lesions, a surgical approach must still be considered and the decision between surgical and transcatheter approaches should be made on an individualized basis.

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Management and Outcomes of Transvenous Pacing Leads in Patients Undergoing Transcatheter Tricuspid Valve Replacement

Management and Outcomes of Transvenous Pacing Leads in Patients Undergoing Transcatheter Tricuspid Valve Replacement View Article Anderson JH, McElhinney DB, Aboulhosn J, Zhang Y, Ribichini F, Eicken A, Whisenant B, Jones T, Kornowski R, Dvir D, Cabalka AK; VIVID Registry JACC Cardiovasc Interv. 2020 Sep 14;13(17):2012-2020. doi: 10.1016/j.jcin.2020.04.054. Epub 2020 Aug 12.PMID: 32800497 Take Home Points: Transcatheter tricuspid valve replacement (TTVR) in the setting of transvenous right ventricular pacemaker leads is feasible and safe. Intra-procedural and long-term attention should be given to transvenous lead dysfunction following intentional lead entrapment by TTVR. There was no significant difference in cumulative incidence of death, TV reintervention, or TV dysfunction on medium-term follow-up of patients with and without pacing leads or entrapped RV leads. Commentary from Dr. Arash Salavitabar (Ann Arbor, USA), section editor of Congenital Heart Disease Interventions Journal Watch:  The authors aimed to answer an important question that often can help decide whether a patient requires transcatheter versus surgical replacement of a tricuspid valve, which is the prevalence of transvenous pacemaker lead complications following transcatheter tricuspid valve replacement (TTVR). This study was performed through the Valve-in-Valve International Database (VIVID) registry and retrospectively analyzed 329 patients who underwent TTVR following surgical TV repair or replacement. Three groups were compared: no lead (n=201), epicardial lead (n=70), and transvenous lead (n=58), with particular focus on those requiring entrapment of transvenous RV leads (see Central Illustration below). Patients who underwent catheterization with intention but without attempt at valve implantation were excluded. The most common type of previous surgical implant was a bioprosthetic valve and most common indication for TTVR was predominantly TR in all 3 groups. Patients with epicardial pacing systems were younger at TTVR (p=0.009), had more prior cardiac surgical procedures (p<0.001), were more likely to have prior bioprosthetic surgical implants (p=0.008), and surgical valve size <29mm (p=0.006). In the 58 patients with a transvenous pacing system who underwent TTVR, the RV lead was entrapped between the TTV and surgical valve/ring in 28. Of the remaining patients, 17 had no RV lead, 10 had a RV lead between the true TV annulus and surgical valve (external to surgical valve), and 3 had the RV lead extracted prior to TTVR. Sapien valves (Edwards Lifesciences) were the predominant transcatheter valve implanted in those with transvenous pacemaker leads. There was a median follow-up period of 15.2 months post-TTVR in these patients. Only 1 patient had a technical modification made related to lead entrapment in order to implant a TTV, which was placement of a covered pre-stent prior to TTVR. Three of 28 patients (10.7%) with intentional RV lead entrapment had complications: lead dislodgment (n=1, TTVR into annuloplasty ring), marked increase in RV lead impedance/stimulation threshold 2 weeks post-TTVR (n=1, TTVR within prior surgical valve), and RV lead fracture 7 months post-TTVR (n=1, TTVR within prior surgical valve). The last of those patients was noted to have early valve failure of the TTV with evidence of thrombus and required surgical valve and RV lead replacement. Procedural outcomes did not differ between patients who did and did not have intentional RV lead entrapment. This study showed that no significant valvular complications were encountered during the peri-procedural or limited follow-up period in this cohort. There was a 7% incidence of RV lead failure in this study at 15.2 months follow-up, which exceeds the rate epicardial lead failure in adults and argues that increased surveillance of these leads is likely warranted after TTVR. The authors admit that longer follow-up will be necessary to determine whether patients who undergo TTVR in the setting of transvenous pacing leads are at risk for accelerated valve dysfunction. However, this study nicely shows that while interventional cardiologists must be aware of the potential complications of transvenous lead dysfunction during and after TTVR, the overall risks of lead and valvular dysfunction are low. While this decision is likely to be individualized until long-term outcomes are better understood, this is a promising option that may be preferable to surgery in many select patients.    

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Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: One-Year Results of the CANOA Randomized Clinical Trial

Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: One-Year Results of the CANOA Randomized Clinical Trial View Article Wintzer-Wehekind J, Horlick E, Ibrahim R, Cheema AN, Labinaz M, Nadeem N,...

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Acute and medium term results of balloon expandable stent placement in the transverse arch-a multicenter pediatric interventional cardiology early career society study

Acute and medium term results of balloon expandable stent placement in the transverse arch-a multicenter pediatric interventional cardiology early career society study View Article Shabana Shahanavaz 1, Osamah Aldoss 2, Kaitlin Carr 2, Brent Gordon 3, Michael D...

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