Featured topics and Editors’ Picks from all of ACC’s JACC Journals. Review Investigates Aortic Bioprosthetic Valve Durability Valve durability has emerged as an important issue in the current era of aortic valve replacement. A review paper published in the Journal of the American College of Cardiology provides an overview of bioprosthetic valve durability. Tania Rodriguez-Gabella, MD, et al., discuss the available data on the durability of aortic bioprostheses; review the definitions, incidence, timing and mechanisms of structural valve degeneration (SVD); and evaluate the current treatment options for valve failure due to SVD. VValve leaflet calcification has been recognized as the main reason for SVD, while patient characteristics such as younger age and larger body mass index, cardiovascular risk factors and variables pertaining to bioprosthetic valves are associated with increased risk. The authors point to a need for a universal definition of SVD using echocardiographic parameters that consider the changes in valve performance over time, as well as a need to standardize echocardiographic recommendations following transcatheter aortic valve replacement and surgical aortic valve replacement. “The significant increase in the use of aortic bioprostheses in recent times will inevitably lead to rising numbers of patients diagnosed with SVD in the next decade,” the authors write. “This should stimulate further research efforts in the prevention and treatment of this entity, particularly if we embrace the possibility of treating younger patients with biological (instead of mechanical) valves.” Rodriguez-Gabella T, Voisine P, Puri R, et al. J Am Coll Cardiol 2017;70:1013-28. TMVR Outcomes Acceptable for Failed Bioprosthetic Valves, Annuloplasty Rings Transcatheter mitral valve replacement (TMVR) was successful in treating high-risk patients with degenerated bioprostheses or failed annuloplasty rings, but mitral valve-in-ring (ViR) was associated with higher rates of procedural complications and mid-term mortality compared with mitral valve-in-valve (ViV) procedures, according to a study published in the Journal of the American College of Cardiology. Sung-Han Yoon, MD, et al., examined 248 patients with previous mitral valve surgery who were treated with TMVR. Of these, 176 patients had TMVR for degenerated mitral bioprosthetic valves, or ViV, and 72 patients had TMVR for failed annuloplasty rings, or ViR procedures. Surgical risk scores were similar between groups. Overall, procedurerelated death, conversion to conventional surgery, left ventricular outflow tract obstruction, valve embolization and left ventricular perforation were observed in 1.2 percent, 2.0 percent, 3.2 percent, 1.6 percent and 0.4 percent of patients, respectively. Technical success was achieved in 92.3 percent of patients, but the ViR group had a significantly lower technical success rate vs. the ViV group (83.3 vs. 96.0 percent) due to more frequent second valve implantation (11.1 vs. 2.8 percent). Re-intervention (16.7 vs. 7.4 percent) and paravalvular leak closure (6.9 vs. 2.3 percent) were also more common in ViR patients. No significant differences were seen between groups in 30-day all-cause mortality, stroke, major or extensive bleeding or major vascular complication. However, the ViR group had more frequent life-threatening or fatal bleeding (8.3 vs. 2.3 percent) and stage two or three acute kidney injury (11.1 vs. 4.0 percent) vs. the ViV group, resulting in a significantly lower procedural success rate in the ViR group (58.3 vs. 79.5 percent). In an editorial comment, John G. Webb, MD, FACC, et al., examine the last ten years of TMVR for failed surgical implants and conclude it is “still ‘under development.’ However, these procedures are poised to become the default therapies when mitral implants fail… Hopefully, new tiered systems of care will allow appropriate access to this new therapy while allowing for sufficient expertise to optimize outcomes.” Yoon SH, Whisenant BK, Bleiziffer S, et al. J Am Coll Cardiol 2017;70:1121-31. Successful CTO PCI Significantly Improves Health Status High technical success rates were achieved with chronic total occlusion (CTO) PCI and significant health status benefits were realized in patients with successful CTO PCI, in a prospective, multicenter registry study, concluded James Sapontis, MD, et al., in a paper published in JACC: Cardiovascular Interventions. The OPEN-CTO study was a comprehensive registry of consecutive patients undergoing hybrid CTO PCI. Technical success was defined as positioning of the guidewire in the distal true lumen of the first CTO attempted, deployment of a balloon or stent with final antegrade TIMI flow grade 2 or 3, residual stenosis <50 percent and no significant side branch occlusion. A total of 1,054 CTO lesions were attempted in 1,000 enrolled patients. The most common indication for CTO PCI was symptom relief. The technical success rate was 86 percent using the core lab definition and 90 percent when determined by the operator without core lab data. The in-hospital death rate was 0.9 percent. Complications included perforations (8.8 percent), periprocedural myocardial infarction (2.6 percent), in-hospital repeat PCI (0.1 percent), referral for emergent surgery (0.7 percent), acute kidney injury (0.8 percent) and major bleeding events (0.3 percent). Among 991 patients discharged alive, 890 had complete baseline and one-month health status data. After CTO-PCI, improvements at one month were observed in Seattle Angina Questionnaire, Rose Dyspnea Scale and Patient Health Questionnaire 8. Greater health status improvement was seen in patients with a successful, vs. unsuccessful, CTO PCI. CTO-PCI operators achieved high technical success rates, but complication rates were higher than described for non-CTO PCI. The authors conclude clarification of success rates, risks and benefits of CTO PCI will aid appropriate patient selection. In an editorial, Carlo Di Mario, MD, PhD, FACC, et al., note the DECISION-CTO and EXPLORE randomized trials reported no advantage with CTO PCI vs. optimal medical therapy. They attribute the difference in results to possible selection bias and lack of discrimination between clinical improvement from PCI in general and CTO PCI in patients with multivessel disease (OPEN-CTO baseline observation was done after non-CTO PCI). Although the claim that CTO PCI saves lives is not supported by randomized trials, they conclude, “There is no doubt, however, that QOL is improved by CTO recanalization.” While the price to pay is higher for non-CTO PCI, “complications, especially perforations, are successfully handled in most cases without surgery.” Sapontis J, Salisbury AC, Yeh RW, et al. JACC: Cardiovasc Interv 2017;10:1523-34. Risks Associated With Transcatheter PDA Occlusions in Lower Weight Infants Transcatheter patent ductus arteriosus (PDA) occlusion is one of the safest interventional cardiac procedures among adults and children. However, major adverse events are five to 10 times greater among infants who weigh less than six kilograms (kg), according to a study published in JACC: Cardiovascular Interventions. Using ACC’s IMPACT Registry, Carl H. Backes, MD, et al., identified 747 infants weighing less than six kg who underwent transcatheter PDA occlusion between January 2011 and March 2015. Across 73 hospitals, the procedural success rate was 94.3 percent, and 96 percent of cases required less than two hours in the catheterization suite. Differences were examined across three weight categories: extremely low weight (ELW, <2 kg), very low weight (VL, 2-<4 kg) and low weight (LW, 4-<6 kg). A third of infants were born at <30 weeks of gestation. At catheterization, median age was 4.3 months and most were LW (4.6 kg). More than half of procedures were performed on females and Caucasians. Less than half of infants were hospitalized before the procedure and more than half were on diuretic treatment. Most infants had a Type A (37 percent) or Type C (42 percent) PDA. While the majority of attempted PDA closures were successful, approximately 13 percent of infants experienced major adverse events (MAEs). “In the present cohort of infants <6 kg, procedural success rates for transcatheter PDA closure are similar to those in more mature counterparts, but rates of MAE were five- to 10-fold greater,” note the study authors. Most common MAEs included acute arterial injury (3.5 percent) and device embolization (2.4 percent). ELW infants (10.5 percent) had a higher risk of embolization than VLW or LW infants (1.6 percent and 2.5 percent, respectively; p = 0.050). Other noted MAEs included arrhythmia requiring intervention, unplanned cardiac surgery and a major bleeding event (<2 percent each). Infants who experienced an MAE were more likely to stay at the hospital a week longer than those who did not (13 vs. 20 days, p = 0.01). Additionally, risk of MAEs (odds ratio [OR], 3.4; 95 percent confidence interval [CI], 1.5-7.9) and composite failure (OR, 3.1; 95 percent CI, 1.4-6.9) was higher among younger patients (<30 days). While the study proves to be an “important first step in understanding the risk profile of transcatheter PDA occlusion in this subgroup of infants,” the authors note that “conclusions on the optimal treatment among lower weight infants with a persistent ductus remain unanswered.” “Conservative treatment may reduce unnecessary interventions in many infants, but the question remains as to what to do if the PDA fails to close following a period of conservative treatment,” they continue. They call for well-designed comparative trials of transcatheter occlusion, surgical ligation and conservative treatment. Backes CH, Kennedy KF, Locke M, et al. JACC: Cardiovasc Interv 2017; 10:1729-37. "The significant increase in the use of aortic bioprostheses in recent times will inevitably lead to rising numbers of patients diagnosed with SVD in the next decade." Rodriguez-Gabella, et al. Mitral valve-in-ring (ViR) was associated with higher rates of procedural complications and mid-term mortality compared with mitral valve-in-valve (ViV) procedures. Read the complete issues, listen to audio summaries, download central illustrations, earn CME/MOC credit, and more at OnlineJACC.org.
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