Abstract

HomeCirculationVol. 141, No. 5Highlights From the Circulation Family of Journals Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUBHighlights From the Circulation Family of Journals Originally published3 Feb 2020https://doi.org/10.1161/CIRCULATIONAHA.119.045595Circulation. 2020;141:401–406Circulation: Arrhythmia and ElectrophysiologyThis multicenter, single-arm, first-in-human clinical trial investigates the feasibility, safety, and short-term efficacy of a compliant radiofrequency balloon catheter with 10 irrigated, flexible electrodes for pulmonary vein isolation. The findings suggest that this novel catheter was efficient, effective, and reasonably safe acute pulmonary vein isolation.Pulmonary Vein Isolation With a Novel Multielectrode Radiofrequency Balloon Catheter That Allows Directionally Tailored Energy DeliveryShort-Term Outcomes From a Multicenter First-in-Human Study (RADIANCE)Vivek Y. Reddy, MDRichard Schilling, MDMassimo Grimaldi, MDRodney Horton, MDAndrea Natale, MDStefania Riva, MDClaudio Tondo, MD, PhDKarl-Heinz Kuck, MDPetr Neuzil, MDKendra McInnis, BSMoe Bishara, MDBaohui Zhang, MPhAssaf Govari, PhDAhmed Abdelaal, MD, PhDMoussa Mansour, MDCorrespondence to: Vivek Y. Reddy, MD, Helmsley Electrophysiology Center, Icahn School of Medicine at Mt Sinai, One Gustave L. Levy Place, Box 1030, New York, NY 10029. Email vivek.[email protected]orgBACKGROUND: Balloon catheters facilitate pulmonary vein (PV) isolation, but current technology is limited by either a single ablative element, potentially leading to overablation of thin and underablation of thick tissue, or prolonged procedure times. Visualized by electroanatomical mapping, a novel compliant radiofrequency balloon catheter with 10 irrigated, flexible electrodes can simultaneously and independently deliver energy. Herein, we evaluated the feasibility, safety, and short-term efficacy of this radiofrequency balloon in a multicenter, single-arm, first-in-human study.METHODS: Paroxysmal atrial fibrillation patients underwent PV isolation with the radiofrequency balloon delivered over-the-wire with a deflectable 13.5F sheath. Radiofrequency energy is delivered simultaneously from all electrodes—up to 30 s posteriorly and 60 s anteriorly. Esophageal temperature was monitored in all patients; the esophagus was also mechanically deviated in 10 patients.RESULTS: At 4 sites, 39 patients were treated by 9 operators. The radiofrequency balloon isolated all targeted PVs (152/152), 79.6% with a single application. Electrical reconnection occurred in only 7/150 PVs (4.7%) on adenosine/isoproterenol challenge. Mean procedure, balloon dwell, and fluoroscopy times were 101.6, 40.5, and 17.4 min, respectively. Esophagogastroduodenoscopy revealed asymptomatic esophageal erythema in 5 patients. Phrenic nerve palsy occurred in a patient in whom phrenic pacing was inadvertently omitted. At 3 months, imaging revealed no PV stenosis, and early atrial arrhythmia recurrence occurred in only 10/39 (25.6%) patients.CONCLUSIONS: The compliant radiofrequency balloon can directionally tailor energy delivery for efficient, effective, and reasonably safe acute PV isolation.CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: ISRCTN 11764506.Circ Arrhythm Electrophysiol. 2019;141:e007541. DOI: 10.1161/CIRCEP.119.007541.Circulation: Genomic and Precision MedicineHeart failure and its echocardiographic precursors are heritable traits; however, the underlying genomic architecture is not completely understood. Using a transomics analytical approach to the Framingham Heart Study, this study integrated genome-wide single-nucleotide polymorphisms, gene expression, and DNA methylation to offers insights into potential molecular and genetic contributors to heart failure and its precursors.Integrated Multiomics Approach to Identify Genetic Underpinnings of Heart Failure and Its Echocardiographic PrecursorsFramingham Heart StudyCharlotte Andersson, MD, PhDHonghuang Lin, PhDChunyu Liu, PhDDaniel Levy, MDGary F. Mitchell, MDMartin G. Larson, SDRamachandran S. Vasan, MDCorrespondence to: Charlotte Andersson, MD, PhD, Department of Cardiology, Gentofte and Herlev Hospital, Herlev, Nordre Ringvej 75, 2730 Herlev, Denmark. Email [email protected]dkBACKGROUND: Heart failure (HF) may arise from alterations in metabolic, structural, and signaling pathways, but its genetic architecture is incompletely understood. To elucidate potential genetic contributors to cardiac remodeling and HF, we integrated genomewide single-nucleotide polymorphisms, gene expression, and DNA methylation using a transomics analytical approach.METHODS: We used robust rank aggregation (where the position of a certain gene in a rank order list [based on statistical significance level] is tested against a randomly shuffled rank order list) to derive an integrative transomic score for each annotated gene associated with a HF trait.RESULTS: We evaluated ≤8372 FHS (Framingham Heart Study) participants (54% women; mean age, 55±17 years). Of these, 62 (0.7%) and 35 (0.4%) had prevalent HF with reduced ejection fraction and HF with preserved left ventricular ejection fraction, respectively. During a mean follow-up of 8.5 years (minimum–maximum, 0.005–18.6 years), 223 (2.7%) and 234 (2.8%) individuals developed incident HF with reduced ejection fraction and HF with reduced ejection fraction, respectively. Top genes included MMP20 and MTSS1 (promotes actin assembly at intercellular junctions) for left ventricular systolic function; ITGA9 (receptor for VCAM1 [vascular cell protein 1]) and C5 for left ventricular remodeling; NUP210 (expressed during myogenic differentiation) and ANK1 (cytoskeletal protein) for diastolic function; TSPAN16 and RAB11FIP3 (involved in regulation of actin cytoskeleton) for prevalent HF with reduced ejection fraction; ANKRD13D and TRIM69 for incident HF with reduced ejection fraction; HPCAL1 and PTTG1IP for prevalent HF with reduced ejection fraction; and ZNF146 (close to the COX7A1 enzyme) and ZFP3 (close to SLC52A1—the riboflavin transporter) for incident HF with reduced ejection fraction. We tested the HF-related top single-nucleotide polymorphisms in the UK biobank, where rs77059055 in TPM1 (minor allele frequency, 0.023; odds ratio, 0.83; P=0.002) remained statistically significant upon Bonferroni correction.CONCLUSIONS: Our integrative transomics approach offers insights into potential molecular and genetic contributors to HF and its precursors. Although several of our candidate genes have been implicated in HF in animal models, independent replication is warranted.Circ Genom Precis Med. 2019;12:e002489. DOI: 10.1161/CIRCGEN.118.002489.Circulation: Cardiovascular ImagingAlthough hypoattenuated leaflet thickening (HALT) has been observed on computed tomography follow-up after transcatheter aortic valve replacement, the causes and hemodynamic and clinical consequences are not fully understood. This study investigated baseline predictors of HALT and assessed 30-day and 1-year hemodynamic and clinical outcomes in an analysis of 170 patients. Although worse valve hemodynamics were found in patients with HALT at 30 days, hemodynamic and clinical outcomes were similar at 1 year. There were no early valve hemodynamic predictors of HALT.Hemodynamics and Subclinical Leaflet Thrombosis in Low-Risk Patients Undergoing Transcatheter Aortic Valve ReplacementJaffar M. Khan, BM, BChToby Rogers, MD, PhDRon Waksman, MDRebecca Torguson, MPHGaby Weissman, MDDiego Medvedofsky, MDPaige E. Craig, MPHCheng Zhang, PhDPaul Gordon, MDAfshin Ehsan, MDSean R. Wilson, MDJohn Goncalves, MDRobert Levitt, MDChiwon Hahn, MDPuja Parikh, MDThomas Bilfinger, MD, ScDDavid Butzel, MDScott Buchanan, MDNicholas Hanna, MDRobert Garrett, MDChristian Shults, MDHector M. Garcia-Garcia, MD, PhDPaul Kolm, PhDLowell F. Satler, MDMaurice Buchbinder, MDItsik Ben-Dor, MDFederico M. Asch, MDCorrespondence to: Federico M. Asch, MD, MedStar Health Research Institute, 100 Irving Street NW, Suite EB5123, Washington, DC 20010. Email federico.[email protected]netBACKGROUND: This analysis evaluated echocardiographic predictors of hypoattenuated leaflet thickening (HALT) in low-risk patients undergoing transcatheter aortic valve replacement and assessed 1-year clinical and hemodynamic consequences. HALT by computed tomography may be associated with early valve degeneration and increased neurological events.METHODS: Echocardiograms were performed at baseline, discharge, 30 days, and 1 year post-procedure. Four-dimensional contrast-enhanced computed tomography assessed HALT at 30 days. Independent core laboratories analyzed images. Doppler hemodynamic parameters were tested in a univariable regression model to identify HALT predictors. One-year clinical and hemodynamic outcomes were compared between HALT (+) and (−) patients.RESULTS: Analysis included 170 patients with Sapien 3 valves and diagnostic 30-day computed tomographies, of whom 27 (16%) had HALT. Baseline characteristics were similar between groups. After transcatheter aortic valve replacement, aortic flow was nonsignificantly reduced in patients who developed HALT. Regression analysis did not show significant association between baseline or discharge valve hemodynamics and development of HALT at 30 days. Patients with HALT had smaller aortic valve areas (1.4±0.4 versus 1.7±0.5 cm2; P=0.018) and Doppler velocity index (0.4±0.1 versus 0.5±0.1; P=0.003) than those without HALT at 30 days but not at 1 year. There was no difference in aortic mean gradient at 30 days. There was no difference between the groups in New York Heart Association class, 6-minute walk distance, and mortality at 1 year.CONCLUSIONS: There were no early hemodynamic predictors of HALT. At 30 days, patients with HALT had worse valve hemodynamics than those without HALT, but hemodynamic and clinical outcomes at 1 year were similar.CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02628899.Circ Cardiovasc Imaging. 2019;12:e009608. DOI: 10.1161/CIRCIMAGING.119.009608.Circulation: Cardiovascular InterventionsThis systematic review and meta-analysis of 7 observational studies aimed to compare the outcomes of deferred versus performed revascularization of coronary lesions with gray-zone fractional flow reserve values in the range of 0.75 to 0.80. In comparison with deferral, revascularization of gray-zone lesions was associated with a similar incidence of major adverse cardiovascular events over a 2.5-year mean follow-up period. There was a higher incidence of target vessel revascularization in the deferred group.Outcomes With Deferred Versus Performed Revascularization of Coronary Lesions With Gray-Zone Fractional Flow Reserve ValuesMichael Megaly, MD, MSCharl Khalil, MDMarwan Saad, MD, PhDIosif Xenogiannis, MDMohamed Omer, MDMahesh Anantha Narayanan, MDAshish Pershad, MDSantiago Garcia, MDArnold H. Seto, MD, MPAM. Nicholas Burke, MDEmmanouil S. Brilakis, MD, PhDCorrespondence to: Emmanouil S. Brilakis, MD, PhD, Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, 920 East 28th Street #100, Minneapolis, MN 55407. Email [email protected]comBACKGROUND: Management of coronary lesions with fractional flow reserve values in the gray zone (0.75–0.80) remains controversial due to conflicting data on the performance versus deferral of revascularization.METHODS: We performed a systematic review and meta-analysis of 7 observational studies including 2683 patients that compared the outcomes of deferred versus performed revascularization of coronary lesions with gray-zone fractional flow reserve values.RESULTS: During a mean follow-up of 31±9 months, the incidence of major adverse cardiovascular events (12.54 % versus 11.25%; odds ratio [OR], 1.64 [95% CI, 0.78–3.44]; P=0.19, I2=84%), cardiac mortality (1.25% versus 0.72%; OR, 1.78 [95% CI, 0.58–5.46]; P=0.31, I2=18%), and myocardial infarction (1.28% versus 2.66%; OR, 0.79 [95% CI, 0.22–2.79]; P=0.71, I2=65%) was similar with deferral versus performance of revascularization in coronary lesions with gray-zone fractional flow reserve. Deferral of revascularization was associated with a higher incidence of target vessel revascularization (9.12% versus 5.78%; OR, 1.85 [95% CI, 1.03–3.33]; P=0.04, I2=62%). When the analysis was limited only to studies that used percutaneous coronary intervention for revascularization, deferred revascularization remained associated with a higher risk of target vessel revascularization (18% versus 7.3%; OR, 3.04 [95% CI, 1.53–6.02]; P<0.001) and was associated with a higher risk of major adverse cardiovascular event (23.2% versus 13.4%; OR, 3.38 [95% CI, 1.92–5.95]; P<0.001).CONCLUSIONS: In lesions with gray-zone fractional flow reserve, revascularization was associated with a similar incidence of major adverse cardiovascular event but a lower incidence of target vessel revascularization over a mean follow-up of approximately 2.5 years.CLINICAL TRIAL REGISTRATION: URL: https://www.crd.york.ac.uk/prospero/. Unique identifier: CRD42019128076.Circ Cardiovasc Interv. 2019;12:e008315. DOI: 10.1161/CIRCINTERVENTIONS.119.008315.Circulation: Cardiovascular Quality and OutcomesThis data report compares author disclosures of relationships with industry in guidelines endorsed by the American College of Cardiology and American Heart Association with payments reported by industry in Open Payments to these same authors. Discrepancies between guideline author disclosures and industry-reported payments highlight potential inaccuracies within the Open Payments database and the disclosure process. The study suggests that professional medical societies, journals, and Open Payments align their reporting methodology to use similar categories and expectations.Analysis of American College of Cardiology/American Heart Association Guideline Author Self-Disclosure Compared With Open Payments Industry DisclosureRamzi Dudum, MD, MPHAparna Sajja, MDRichard L. Amdur, PhDBrian G. Choi, MD, MBACorrespondence to: Brian G. Choi, MD, MBA, George Washington University School of Medicine and Health Sciences, 2150 Pennsylvania Ave NW, Suite 4-417, Washington, DC 20037. Email [email protected]eduCirc Cardiovasc Qual Outcomes. 2019;12:e005613. DOI: 10.1161/CIRCOUTCOMES.119.005613.Circulation: Heart FailureThis study analyzes sex-related differences in characteristics and outcomes of heart failure with preserved ejection fraction using data from participants enrolled in the CHARM-Preserved (Candesartan in Heart failure: Assessment of Reduction in Mortality and Morbidity), I-Preserve (Irbesartan in Heart Failure With Preserved Ejection Fraction), and TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial) trials. Women with heart failure with preserved ejection fraction have better survival than men, but with more congestion, a lower quality of life, and similar hospitalization rates.Sex-Related Differences in Heart Failure With Preserved Ejection FractionPooja Dewan, MBBSRasmus Rørth, MDValeria Raparelli, MD, PhDRoss T. Campbell, MBChB, PhDLi Shen, MBChB, PhDPardeep S. Jhund, MBChB, PhDMark C. Petrie, MBChBInder S. Anand, MD, DPhilPeter E. Carson, MDAkshay S. Desai, MD, MPHChristopher B. Granger, MDLars Køber, MD, DMScMichel Komajda, MDRobert S. McKelvie, MD, PhDEileen O’Meara, MDMarc A. Pfeffer, MD, PhDBertram Pitt, MDScott D. Solomon, MDKarl Swedberg, MD, PhDMichael R. Zile, MDJohn J.V. McMurray, MDCorrespondence to: John J.V. McMurray, MD, British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow, G12 8TA, United Kingdom. Email john.[email protected]ac.ukBACKGROUND: To describe characteristics and outcomes in women and men with heart failure with preserved ejection fraction.METHODS: Baseline characteristics (including biomarkers and quality of life) and outcomes (primary outcome: composite of first heart failure hospitalization or cardiovascular death) were compared in 4458 women and 4010 men enrolled in CHARM-Preserved (Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity) (EF≥45%), I-Preserve (Irbesartan in heart failure with Preserved ejection fraction), and TOPCAT-Americas (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial).RESULTS: Women were older and more often obese and hypertensive but less likely to have coronary artery disease or atrial fibrillation. Women had more symptoms and signs of congestion and worse quality of life. Despite this, the risk of the primary outcome was lower in women (hazard ratio, 0.80 [95% CI, 0.73–0.88]), as was the risk of cardiovascular death (hazard ratio, 0.70 [95% CI, 0.62–0.80]), but there was no difference in the rate for first hospitalization for heart failure (hazard ratio, 0.92 [95% CI, 0.82–1.02]). The lower risk of cardiovascular death in women, compared with men, was in part explained by a substantially lower risk of sudden death (hazard ratio, 0.53 [0.43–0.65]; P<0.001). E/A ratio was lower in women (1.1 versus 1.2).CONCLUSIONS: There are significant differences between women and men with heart failure with preserved ejection fraction. Despite worse symptoms, more congestion, and lower quality of life, women had similar rates of hospitalization and better survival than men. Their risk of sudden death was half that of men.CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00853658, NCT01035255.Circ Heart Fail. 2019;12:e006539. DOI: 10.1161/CIRCHEARTFAILURE.119.006539.Footnoteshttps://www.ahajournals.org/journal/circ Previous Back to top Next FiguresReferencesRelatedDetails February 4, 2020Vol 141, Issue 5 Advertisement Article InformationMetrics © 2020 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.119.045595PMID: 32011923 Originally publishedFebruary 3, 2020 PDF download Advertisement

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