Congenital Heart Interventions

Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis Shahanavaz S, Zahn EM, Levi DS, Aboulhousn JA, Hascoet S, Qureshi AM, Porras D, Morgan GJ, Bauser Heaton H, Martin MH, Keeshan B, Asnes JD, Kenny D, Ringewald JM, Zablah JE, Ivy M, Morray BH, Torres AJ, Berman DP, Gillespie MJ, Chaszczewski K, Zampi JD, Walsh KP, Julien P, Goldstein BH, Sathanandam SK, Karsenty C, Balzer DT, McElhinney DB. J Am Coll Cardiol. 2020 Dec 15;76(24):2847-2858. doi: 10.1016/j.jacc.2020.10.041. PMID: 33303074   Take Home Points: Acute and limited short-term outcomes after TPVR with the Sapien valve were generally excellent in all types of RVOTs. There was a 10% rate of serious procedural adverse events and 1.7% per patient year rate of endocarditis occurring up to 16 months post valve implant. The question of native RVOT pre-stenting remains unresolved but use of a Gore DrySeal should be encouraged to minimize tricuspid valve injury.   Commentary from Dr. Konstantin Averin (Edmonton), chief catheterization section editor of Pediatric Cardiology Journal Watch: Two valve systems are currently FDA approved for transcatheter pulmonary valve replacement (TPVR) in the US – the Melody valve (Medtronic, Minneapolis, MN) and the Edwards Sapien Valve (Edwards Lifesciences, Irvine, California). There is robust data on outcomes with the Melody valve (up to 10 years follow up) but large series describing even procedural outcomes of 2nd (XT) and 3rd (S3) generation Sapien valve implantation are lacking. In this paper, Dr. Shahanaz and her co-authors report on procedural and short-term outcomes of the XT and S3 valves from a large retrospective unaudited registry – COMPASSION S3 (Evaluation of the Sapien S3 Transcatheter Heart Valve in Patients with Pulmonary Valve Dysfunction).   From January 1, 2008 to August 28, 2019 774 patients from 23 centers underwent attempted TPVR (defined as valve introduced into the body). Technical success (no death or explant within 24 hours) was achieved in 97.4% and clinical success (technical success with less than moderate PR and peak Doppler gradient <40 mmHg) in 89%. Most patients were between 12-50 years of age (78%) with an equal number <12 and >50. Almost exactly half of patients had native/patched RVOTs with the remainder having a conduit or stented bioprosthetic valve. The most common diagnosis was tetralogy of Fallot with a variety of other RVOT pathologies. An S3 valve was used in 78% of cases with an XT used in the remainder. Valve delivery was via the femoral route in 93% of cases and a long Gore DrySeal sheath used in at least 152 (20%) – potentially more as this was not a specific data field. The Gore DrySeal sheath is increasingly utilized to facilitate valve delivery to the RVOT and minimize the risk of tricuspid valve injury. Slightly more patients in the entire cohort had a pre-stent implanted than not (54% v 46%) and in a similar ratio was found in the native RVOT group (59% v 41%).   Of the 20 technically unsuccessful procedures – 4 had a valve introduced but not implanted, 14 had the valve removed within 24 hours, and 2 died from pulmonary artery rupture. Not surprisingly, patients less than 30kg were less likely to have a technically successful procedure (90.4% v 97.9%, p = 0.008). Serious procedural adverse events occurred in 67 patients (10% of those with available data) – 11 (1.7%) with tricuspid valve injury (1/20 using DrySeal sheath); 30 (4.5%) with valve or stent embolization (12 requiring surgery); only 2 patients with coronary artery or aortic root compression requiring urgent surgery and a small number of other complications. Importantly, 9 patients were diagnosed with endocarditis 0.2 months to 16 months post-valve implant (1.7% per patient-year) which is slightly but not significantly better than the rate reported with Melody valve (~2-3% per year).   Acute and limited short-term outcomes after TPVR with the Sapien valve were generally excellent in all types of RVOTs. There are important complications that operators need to consider and take steps to mitigate when possible. The question of whether to pre-stent (especially in native RVOTs) remains unanswered as does the question of endocarditis risk (relative to the Melody valve). It does seem that use of a Gore DrySeal sheath minimizes the risk of tricuspid valve injury and its use should be considered until alternative delivery systems are available.   

Pediatric/Congenital Cardiac Catheterization Quality: An Analysis of Existing Metrics O'Byrne ML, Huang J, Asztalos I, Smith CL, Dori Y, Gillespie MJ, Rome JJ, Glatz AC. JACC Cardiovasc Interv. 2020 Dec 28;13(24):2853-2864. doi: 10.1016/j.jcin.2020.09.002. PMID: 33357522   Take Home Points: Existing quality metrics in the pediatric cardiac catheterization lab nearly all currently focus on safety, either as an outcome (adverse events, radiation, etc.) or as a safety structure (procedural volume, operator experience). There is not currently a good metric for procedural efficacy, despite this measure being a perceived priority by practicing interventionalists. Risk adjustment is particularly important when comparing outcomes between and within centers, in the heterogenous world of congenital heart disease, however there is little confidence among interventionalists about current risk-adjustment methodologies.   Commentary from Dr. Wendy Whiteside (Ann Arbor, MI, USA), section editor of Congenital Heart Disease Interventions Journal Watch: In this article, O’Byrne et al provide a systematic evaluation of the current state of quality metrics in the pediatric cardiac catheterization lab (PCCL). Their review involved evaluation of quality metrics via 3 mechanisms: 1. Review of peer-reviewed research, 2. Review of metrics from organizations/professional societies interested in quality, and 3. Survey of pediatric interventional cardiologists in the US. This manuscript provides insight into many of the deficiencies of the current quality landscape in the PCCL.   All of the metrics identified in the 9 papers reviewed, were related to patient safety. The majority of these were related to outcome metrics including adverse events, failure to rescue, and radiation, with the remainder (33%) of the references referring to safety structures including procedural and operator volume and experience. While there is no question that safety is of paramount importance in a procedural space such as the PCCL, there are multiple other areas of quality in the Institute of Medicine Quality Domains (including effectiveness, efficiency, timeliness, equity, and patient-centeredness) which are currently voids in the PCCL quality literature and need to be areas of future study within this field. Additionally, consensus on the structures and processes associated with good quality care in the PCCL needs to be reached.   Among quality-measuring organizations/societies, a minority (only 4, 22%) propose or measure quality metrics from PCCL programs. The majority of the US News & World Report score for pediatric cardiology and cardiovascular surgery programs involving the cath lab are related to procedural volume and not at all to procedural safety or efficacy. This is a problem as this tells only part of the story related to the quality of a particular program’s cath lab. Part of why this problem likely exists is because good metrics for procedural safety, and even more so, for procedural efficacy don’t currently exist for many procedures. Three existing registries, including the IMPACT registry, the Congenital Cardiac Catheterization Project on Outcomes (C3PO) collaborative, and the Congenital Cardiovascular Interventional Study Consortium (CCISC) Risk Registry, provide member institutions their own quality metrics for review, but none are flawless. The IMPACT registry, while large, is not risk -adjusted and includes a simplified dichotomy for procedural success which is not clinically useful for many of the procedures evaluated. C3PO reports provide risk adjusted adverse events and radiation data and allows for comparison to other member institutions, but is limited in its scope with only a small subset of programs participating. While safety has been the focus, is reported by the 3 physician organized registries (IMPACT, C3PO, and CCISC), and is a stated priority of the surveyed interventionalists, there is still not consensus on how to properly measure this, with the majority of survey respondents not confident with the effectiveness of current risk adjustment methodologies.   When we look at areas within pediatric cardiology who have done well with collecting, using, and acting on quality data, cardiac intensive care (PC4—the Pediatric Cardiac Critical Care Consortium) and cardiac surgery (STS—the Society of Thoracic Surgeons—Congenital Database) are two areas to learn from. While the PCCL still has room to improve on risk adjustment methodologies, much work also needs to be focused on procedural efficacy and providing a metric that can account for the subtleties of procedural outcomes in this field (Less residual aortic stenosis after aortic balloon valvuloplasty may not be better if it creates more aortic insufficiency). Additionally, trust and transparency in the data is necessary and will need to be built into existing registries moving forward. While our intentions in assessing PCCL quality have always been true, the focus now needs to be on tackling the more challenging metrics to define and measure. We need to move as a field towards better defining those metrics we know are important to us, and how best to measure and compare these to allow for learning and improvement in the field as a whole.