Featured topics and Editors’ Picks from all of ACC’s JACC Journals. NCDR Study Finds PCI Operators Perform Low Volume of PCI Procedures Annually Many PCI operators in the U.S. perform fewer than the recommended number of PCI procedures annually, according to a study published June 12 in the Journal of the American College of Cardiology. Using data from ACC’s CathPCI Registry, Alexander C. Fanaroff, MD, et al., looked at operator annual PCI volume between July 1, 2009 and March 31, 2015. Operators were divided into three groups by annual PCI volume: low (100). Results showed that the median annual number of procedures performed per operator was 59, and 44 percent of operators performed <50 PCI procedures per year – the number of procedures recommended by the ACC/AHA/ SCAI 2013 Update of the Clinical Competence Statement on Coronary Artery Interventional Procedures. In addition, low-volume operators more frequently performed emergency and primary PCI procedures and practiced at hospitals with lower annual PCI volumes. The adjusted risk of in-hospital mortality was higher for PCI procedures performed by low- and intermediate-volume operators compared with those performed by high-volume operators (adjusted odds ratio, 1.16 for low vs. high volume; adjusted odds ratio, 1.05 for intermediate vs. high volume). The authors add that “although absolute risk differences are small and may be partially explained by unmeasured differences in case mix between operators, there remains an inverse relationship between PCI operator volume and in-hospital mortality that persisted in risk-adjusted analyses.” Moving forward, they conclude that “future studies should identify measurable process and outcome variables other than case volume that better correlate with operator competency.” In a related editorial comment, Dharam J. Kumbhani, MD, SM, FACC, and Brahmajee K. Nallamothu, MD, FACC, explain that, “The bottom line is that we need to seriously rethink our obsession with volume benchmarks, a metric that we have assiduously clung to for the past several decades. Volume may be among the factors, but it should be only considered under a quality assessment program that is more comprehensive. The practice of interventional cardiology in 2017 looks very different from its inception in 1977, and it is high time that quality assessment is updated from 1977 to 2017 as well.” Fanaroff AC, Zakroysky P, Dai D, et al. J Am Coll Cardiol 2017;69:2913-24. Obesity Paradox Observed in PCI Outcomes An elevated body mass index (BMI) may be a predictor of greater survival after PCI, according to research published July 3 in JACC: Cardiovascular Interventions. Eric W. Holroyd, MD, and colleagues obtained data on 345,192 participants from the British Cardiovascular Intervention Society registry between 2005 and 2013. Based on BMI, patients were categorized as either lean, normal, overweight or obese. The percentage of obese patients undergoing PCI was 30 percent in 2005 and 32 percent in 2013. Obese patients were significantly younger, while lean patients were significantly older. The odds of 30-day mortality were significantly lower in both overweight and obese patients, but did not reach statistical significance in the lean group. Similar observations were recorded at one year, with independent decreases in the odds of mortality in the overweight and obese groups and independent increases in odds of mortality in the lean group. Similar trends were recorded at three and five years. The odds for in-hospital bleeding complications were significantly less in obese patients following multivariate analysis compared with patients with normal BMIs and lean patients, which the authors attribute to higher rates of radial access in these patients. The researchers observed this obesity paradox with PCI in both stable coronary disease and in more acute clinical situations. These findings support previous research for outcomes based on BMI after coronary revascularization. However, the authors write that the factors underlying this phenomenon remain uncertain and controversial and this study provides support for further exploration. In an accompanying editorial comment, Debabrata Mukherjee, MD, FACC, and Chandra Ojha, MD, FACC, discuss the translation of these observations into meaningful advice for clinical practitioners and stress the importance of cardiorespiratory fitness for optimal cardiovascular outcomes. “We should emphasize the importance of physical activity for everyone across all BMI levels, with 30 to 60 min of moderateintensity aerobic activity, such as brisk walking, at least five days and preferably seven days per week,” they write. “Consistent with national guidelines, we also recommend that patients with established CVD undergo risk assessment with a physical activity history or an exercise test before starting an exercise program.” Holroyd EW, Sirker A, Kwok CS, et al. JACC Cardiovasc Interv 2017;10:1283-92. Read the complete issues, listen to audio summaries, download central illustrations, earn CME/MOC credit, and more at OnlineJACC.org. Frailty Measured by EFT Best Predicts Death, Disability After TAVR and SAVR Frailty as measured by the Essential Frailty Toolset (EFT) was the strongest predictor of death and disability in older adults after transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), according to a study published July 7 in the Journal of the American College of Cardiology. FRAILTY-AVR, the largest prospective study to date to examine frailty in this population, found there was incremental predictive value above existing risk models when frailty was measured objectively with a validated scale. The EFT, consisting of just four items (the time required to stand five times from a seated position without using arms, cognition, hemoglobin and serum albumin), was compared against six other frailty scales. In addition, they assessed the patients’ physical activity, comorbidities, procedural details, pre- and post-procedural laboratory results, and echocardiography, cardiac catheterization, and computed tomography data. The predicted risk of mortality (PROM) was calculated using The Society of Thoracic Surgeons (STS) risk model. The primary outcome was death from any cause at 12 months. A total of 646 patients underwent TAVR and 374 underwent SAVR. Their median age was 82 years and overall median STS-PROM was 4.3 percent. There were 145 (14 percent) deaths during the first year. The prevalence of frailty ranged from 26 percent to 68 percent, depending on the scale. Frailty was highest among non-survivors and was two-fold higher in TAVR than SAVR patients. On multivariate analysis, the EFT had the strongest association with one year mortality (odds ratio [OR], 3.72). Compared with the other frailty scales, EFT provided the greatest incremental predictive value for mortality in a model including the STS-PROM and procedure type. The EFT also was the best predictor of death or worsening disability (OR, 2.13), which occurred in 35 percent of patients at one year, and was associated with an adjusted OR of 3.29 for 30-day mortality. The authors state that although the likelihood of procedural success and short-term survival was very high in the study, the incidence of subsequent functional decline and poor patient-centered outcomes at one year was 35 percent overall – and greater than 50 percent in patients who were frail. In recommending the evaluation of frailty in this population, they write, “The advantages of the EFT, beyond its predictive value, are that it is quick to perform, it does not require specialized equipment, and, importantly, its components have high interobserver reliability and are actionable.” Afilalo J, Lauck S, Kim DH, et al. J Am Coll Cardiol 2017 July 7:[Epub ahead of print]. More TAVR Experience Leads to Better Patient Outcomes Hospitals where a greater number of transcatheter aortic valve replacement (TAVR) procedures are performed have better patient outcomes, suggesting that concentrating experience in higher volume heart valve centers might be a means of improving outcomes, according to a study published June 26 in the Journal of the American College of Cardiology. John D. Carroll, MD, FACC, et al., examined data from 42,988 procedures conducted at 395 hospitals participating in The Society of Thoracic Surgeons/ACC Transcatheter Valve Therapy (TVT) Registry from 2011 to 2015 to assess in-hospital major adverse events. Increasing site volume was associated with lower in-hospital risk-adjusted outcomes, including mortality (p < 0.02), vascular complications (p < 0.003) and bleeding (p < 0.001), but was not associated with stroke (p = 0.14). From the first case to the 400th case in the volume-outcome model, risk-adjusted adverse outcomes declined, including mortality (3.57 percent to 2.15 percent), bleeding (9.56 percent to 5.08 percent), vascular complications (6.11 percent to 4.20 percent) and stroke (2.03 percent to 1.66 percent). These rates were calculated for the “average” patient who carries the average characteristics of the overall study population. The association between TAVR volume and outcomes was most pronounced in the first 100 cases, indicating there may be an early learning curve for the procedure. Beyond the initial 100 cases, procedural risk continued to decline but at a more gradual rate. In an accompanying editorial, Alain Cribier, MD, FACC, et al., writes that, “the information from this report might help updating recommendations of institutional and operator requirements when planning for programmatic expansion in the United States. Concentrating experience in high-volume centers should be favored to improve outcomes, more particularly when TAVR is likely to expand to lower-risk or younger patients.” Carroll JD, Vemulapalli S, Dai D, et al. J Am Coll Cardiol 2017;70:29-41. Can Pulsed Cavitation Ultrasound Improve Valve Function? Pulsed cavitation ultrasound (PCU) can be used to remotely soften human degenerative calcified biosprosthetic valves and may significantly improve the valve opening function, according to a study published June 16 in JACC: Basic to Translational Science. Olivier Villemain, MD, et al., examined the effects of PCU on human bioprosthetic heart valves that were removed from patients because they were heavily calcified and were non-functional. PCU, also called histotripsy, uses shortpulses of focused high-pressure ultrasound to soften biological tissue. The ultrasound is delivered by a transducer that can be placed outside of the body and directed in a focused manner to the area of interest. The removed valves were surgically implanted in sheep or were studied in an experimental bath apparatus to examine the longer-term effects of PCU. The researchers found that PCU was able to soften the stiff calcified valves and improve valve function. The amount of stenosis of the calcified aortic valves decreased by about two-fold on average in both the animal model and the experimental apparatus. The researchers believe this new noninvasive approach has the potential to improve the outcome of patients with severe calcified bioprosthesis stenosis by avoiding risky surgical or transcatheter reintervention. This study was designed as a proof of concept study and did not evaluate the potential risk of PCU causing pieces of the calcified aortic valve breaking off and causing an embolic stroke. “The results of this experimental study must be regarded as provisional because neither the safety nor efficacy of this technique have been evaluated in humans,” commented Douglas L. Mann, MD, FACC, editor-in-chief of JACC: Basic to Translational Science. “However, the concept of using high energy ultrasound to restore the function of calcified artificial tissue valves, analogous to the manner in which nephrologists use ultrasound to break up kidney stones, is both provocative and exciting. The ultrasound devices to perform this type of therapy exist today, so the ability to translate these concepts to patients can move very quickly.” Villemain O, Robin J, Bel A, et al. JACC: Basic Transl Sci 2017;June 16:[Epub ahead of print]. New Insights into SCAD and Its Association With Pregnancy Women with pregnancyassociated spontaneous coronary artery dissection (P-SCAD) have more acute presentations and high-risk features than women with SCAD not associated with pregnancy (NP-SCAD), according to results from a novel study published July 17 in the Journal of the American College of Cardiology. Marysia S. Tweet, MD, FACC, et al., analyzed records of 54 women who had SCAD while pregnant or ≤12 weeks postpartum between July 2011 and February 2016, and compared them with 269 NP-SCAD patients. Approximately half of the enrolled patients participated virtually in the Mayo Clinic SCAD registry. The mean age of P-SCAD patients was 35 ± 4 years. The majority of women with P-SCAD were Caucasian, older at the time of their first childbirth and had multiple pregnancies compared with NP-SCAD patients; however, no difference was found in the number of live childbirths. The study resulted in multiple novel findings, identifying the timeline, associated risks and potential factors for patients with P-SCAD. For example, 70 percent of P-SCAD-related events occurred during the first month following delivery or miscarriage, while 54 percent occurred within the first week (median 5 days). “This timing might correlate in part with the cardiac stress due to the rapid post-delivery uterine contraction and return of massive blood volume to the systemic circulation. However, hemodynamic changes alone might not account for the entire pathogenesis of SCAD,” write the study authors. Compared with women with NP-SCAD, P-SCAD patients were also more likely to present with STEMI (57 vs. 37 percent; p = 0.009), left main SCAD (24 vs. 5 percent; p <0.0001), multivessel SCAD (33 vs. 14 percent; p = 0.00237) and left ventricular function ≤35 percent (26 vs. 10 percent; p = 0.0071). Medical therapy was more likely to fail in P-SCAD patients, resulting in subsequent revascularization. The study authors also found P-SCAD patients had a lower prevalence of fibromuscular dysplasia (42 vs. 64 percent; p = 0.047) and extracoronary vascular abnormalities (46 vs. 77 percent; p = 0.0032) than NP-SCAD patients who underwent extracoronary vascular imaging. “This unexpected observation is hypothesis generating, highlighting the potential importance of other contributing factors in P-SCAD,” they continue. Upon comparing the study results to U.S. birth data, researchers found P-SCAD patients were more often multiparous (p = 0.0167), treated for infertility (p = 0.0004) and had pre-eclampsia (p = 0.001). They note that the “overlap of P-SCAD with pre-eclampsia and similar pattern of presentation with PPCM [post-partum cardiomyopathy] observed in our study is hypothesis generating, particularly because pre-eclampsia and PPCM are speculated as possibly sharing mechanisms of pathogenesis.” “In addition to these findings, what is remarkable about this study is how it reflects the great progress that has been made in understanding SCAD (pregnancyassociated or not) during the past decade and the rapid evolution of this field,” states Heather L. Gornik, MD, FACC. In a related editorial comment, Gornik highlights how SCAD survivors are “highly motivated to participate in clinical research,” but that only nine observational or interventional studies have enrolled SCAD patients thus far. She hopes to “see an exponential proliferation of clinical and translational research studies to further understand the pathogenesis of SCAD, to identify mechanisms for primary and secondary prevention, and to determine the best treatment approach.” Tweet MS, Hayes SN, Codsi E, et al. J Am Coll Cardiol 2017;70:426-35.
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