Congenital Heart Interventions

Balloon-Expandable Cheatham-Platinum Stents Versus Self-Expandable Nitinol Stents in Coarctation of Aorta: A Randomized Controlled Trial. Sadeghipour P, Mohebbi B, Firouzi A, Khajali Z, Saedi S, Shafe O, Pouraliakbar HR, Alemzadeh-Ansari MJ, Shahdi S, Samiei N, Sadeghpour A, Babaei M, Ghadrdoost B, Afrooghe A, Rokni M, Dabbagh Ohadi MA, Hosseini Z, Abdi S, Maleki M, Bassiri HA, Haulon S, Moosavi J. JACC Cardiovasc Interv. 2022 Feb 14;15(3):308-317. doi: 10.1016/j.jcin.2021.11.025.PMID: 35144787   Take Home Points: In this small, single center, randomized controlled study, both balloon-expandable and self-expandable stents can be used for the treatment of native coarctation of the aorta in adults with good procedural success and low periprocedural complications. No significant differences were found between the two stent types in the acute periprocedural complications, stent performance, or short term (1-year) follow up. Additional study of these stent types, over a longer period of follow-up, will be required in order to fully understand whether the performance of these stents is in fact comparable over a longer period of time. Commentary from Dr. Wendy Whiteside (Ann Arbor, MI, USA), section editor of Congenital Heart Disease Interventions Journal Watch: In this article, Sadeghipour et al describe results of their single center randomized controlled study comparing the safety and efficacy of balloon-expandable versus self-expanding stents in native coarctation of the aorta. While BES are commonplace for treatment of coarctation, some unique benefits of SES (including ease and accuracy of deployment) may make their use more appealing.   The study evaluated 92 eligible adult patients with a median age of 30 years and with native coarctation of the aorta between 1/2017-12/2019. Primary outcome of the study was a composite of procedural and vascular complications. Secondary outcome included the incidence of aortic recoarctation, aortic aneurysm/pseudoaneurysm formation, and residual hypertension at 12-month follow-up. Only uncovered stents were used in this study, with patients randomized to receive a Cheatham-platinum balloon-expandable stent (BES) or an uncovered nitinol self-expanding stent (SES-- Optimed Sinus-XL stent). All cases were performed under mild sedation/local anesthesia. Femoral arterial and right radial access was obtained in all patients. Access was obtained using only fluoroscopic landmarks in all patients, and for consistency, all patients had femoral arterial access site upsized to a 12 French arterial sheath for the stent implantation. The CP stent was hand mounted on a BIB balloon, and temporary rapid ventricular pacing was utilized in the BES group. The authors state that if residual gradient exceeded 10 mmHg, balloon post-dilation was performed, however there was no breakdown of how frequently and which patients required this. Procedural and post-procedural anticoagulation was the same across all patients- heparin during the procedure, ASA/Plavix for 1 month, and ASA alone indefinitely.   The two groups were similar in baseline imaging and clinical characteristics. Procedural success was 100%, with reduction in gradient from mean of 62.2±16.4 mmHg in BES and 65.6±19 mmHg in the SES group to 1.5±3.2 mmHg in the BES and 1.4±4.2 mmHg in SES groups (p=0.52). The primary outcome, composite of periprocedural complications and vascular access complications, occurred in 6.5% of patients in the overall cohort (4.3% procedural and 2.2% vascular access) without a significant difference between groups. Primary outcome was observed in 5 patients (10.9%) in the BES group and 1 patient (2.2%) in the SES group (OR 0.18, p=0.20). Procedural complications included periprocedural stent migration, acute cerebrovascular accident, massive pericardial effusion, and aortic dissection. Vascular complications, including non-flow limiting femoral artery dissection, femoral artery pseudoaneurysm, and retroperitoneal hemorrhage occurred in 1.1% of the overall cohort (2 patients, 4.3% in the BES group and no patients in the SES group, p=0.49).   In regards to secondary outcomes, 5 patients (5.4%) had confirmed aortic recoarctation during the 1 year follow-up with no difference in incidence between groups (3 patients, 6.5% in the BES group and 2 patients, 4.3%, in the SES group; OR 0.65, CI 0.10-4.09, p=0.64). One of these patients required placement of an additional stent and all others received balloon angioplasty of existing stent alone. One re-dilation in the BES group was complicated by aortic pseudoaneurysm formation, subsequent treated with aortic stent graft implantation. Blood pressure control was achieved in 50% of patients, with no difference between groups.   While this single center study was small and underpowered, it does show that both approaches to treatment of native coarctation of the aorta in adults, with balloon expandable or self-expanding stents, is acutely successful, with low rates of periprocedural complications, and low rates of recoarctation at 1 year follow-up. Some limitations, however, include no data provided on stent post-dilation—one would suspect that the radial force of a SES alone may not be enough to expand the coarctation segment in some patients and therefore the SES group may have a higher rate of stent post-dilation in order to achieve successful (low stent gradient) stent implantation, however this is not discussed at all other than to say that stent dilation was performed when necessary. Some procedural techniques, including lack of ultrasound use for vascular access, use of rapid pacing for BES implantation, and no use of vascular closure device at the conclusion of the case, are techniques that may differ between centers and may have direct impact on some of the complications seen. Additionally, and of high importance, is that follow-up only occurred over 12 months, so the long term stent performance and complications are not known from this study. It would be very interesting to observe these patients for longer follow-up to determine future rates of stent fracture, recoarctation, aneurysm formation, and need for future transcatheter or surgical intervention in the cohort as a whole, and between groups. Additionally, the two stents used here represent only one example of the many options of stents within these two stent types (BES and SES), so limit the generalizability of these results across centers where different stents are available and are used.   

Transcatheter Closure of Peri-membranous Ventricular Septal Defect Using the Lifetech Konar-Multi Functional Occluder: Early to Midterm Results of the Indonesian Multicenter Study. Kuswiyanto RB, Gunawijaya E, Djer MM, Noormanto, Rahman MA, Murni IK, Sukardi R, Utamayasa A, Ardiansyah R, Nova R, Liliyanti S, Rahayuningsih SE, Anggriawan SL, Rahayuningsih TY, Koentartiwi D, Soewarniaty R, Yantie VK, Nugroho S, Hidayat T, Ontoseno T, Tobing TC, Ali M, Bashari MH, Yosy DS, Arafuri N, Hilmanto D, Yanuarso PB, Advani N, Sastroasmoro S, Putra ST.Glob Heart. 2022 Feb 24;17(1):15. doi: 10.5334/gh.1106. eCollection 2022.PMID: 35342698   Take Home Points: Transcatheter closure of perimembranous ventricular septal defects is routinely performed in resource limited countries. The Lifetech Konar Multi-Functional Occluder (Konar MF VSD Occluder) is safe and effective for the closure of pmVSDs. The device has characteristics that make it suitable for closing various types of pmVSDs. Commentary from Dr. Konstantin Averin (New York), catheterization section editor of Pediatric Cardiology Journal Watch: In this study Kuswiyanto et al describe a prospective multi-center study to assess the feasibility and efficacy of perimembranous ventricular septal defect (pmVSD) closure using the Lifetech Multifunctional Occluder (MFO, now rebranded as Lifetech MF VSD Occluder) (Figure below). While the initial experience with a purpose made pmVSD device in the early 2000s was disappointing due to an unacceptably high incidence of complete heart block, pmVSD closure has become relatively routine in resource limited countries using a variety of new devices, including the Lifetech MFO.   From January 2016 to December 2017 195 patients underwent pmVSD closure with the Lifetech MFO at 11 centers in Indonesia; 55 patients did not have complete data so were excluded as were 8 adult patients. Thus, the study cohort was comprised of 132 patients – median age 4.5 years (range 0.3-17.4) and median weight 14.8 kg (range 3.5-57.0). The inclusion criteria were reasonable. There was a high successful implantation rate during the first or second attempt (~98%) with 31% of implants performed retrograde while the rest were antegrade. Acute occlusion occurred in 68.2% of patients. There were 3 device embolization within 24 hours of device implant and no other significant pre-discharge complications (no 2/3rd degree heart block). Of 126 patients who were discharged with a device, 12-month follow up was available in all. There was complete occlusion in 99.2% with no evidence of 2nd or 3rd degree heart block. No patients had greater than mild aortic regurgitation and 4 patients had moderate tricuspid regurgitation (3 infants with large devices).   The authors should be congratulated on this contribution to the literature, again demonstrating that the Lifetech Konar MFO is effective in closing pmVSDs in a heterogenous group of patients (ranging in size from 3.5 to 57 kg). The Lifetech Konar MF has several characteristics which make it well suited for closing pmVSDs – it can be deployed both antegrade and prograde, has a relatively low profile, is soft and can articulate giving it the ability to conform to a given anatomy and minimize pressure on the myocardium/conduction tissue. As the experience in Asia (and other countries) increasingly demonstrates the effectiveness of this device, it may eventually become possible to offer this procedure to patients in North America.