Cardiology

Dewan, P., P. S. Jhund, L. Shen, M. C. Petrie, W. T. Abraham, M. Atif Ali, C. H. Chen, A. S. Desai, K. Dickstein, J. Huang, S. Kiatchoosakun, K. S. Kim, L. Kober, W. T. Lai, Y. Liao, U. M. Mogensen, B. H. Oh, M. Packer, J. L. Rouleau, V. Shi, A. S. Sibulo, Jr., S. D. Solomon, P. Sritara, K. Swedberg, H. Tsutsui, M. R. Zile and J. J. V. McMurray (2018). “Heart failure with reduced ejection fraction: comparison of patient characteristics and clinical outcomes within Asia and between Asia, Europe and the Americas.” Eur J Heart Fail Dec 10. [Epub ahead of print].

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AIMS: Nearly 60% of the world’s population lives in Asia but little is known about the characteristics and outcomes of Asian patients with heart failure with reduced ejection fraction (HFrEF) compared to other areas of the world. METHODS AND RESULTS: We pooled two, large, global trials, with similar design, in 13 174 patients with HFrEF (patient distribution: China 833, India 1390, Japan 209, Korea 223, Philippines 223, Taiwan 199 and Thailand 95, Western Europe 3521, Eastern Europe 4758, North America 613, and Latin America 1110). Asian patients were younger (55.0-63.9 years) than in Western Europe (67.9 years) and North America (66.6 years). Diuretics and devices were used less, and digoxin used more, in Asia. Mineralocorticoid receptor antagonist use was higher in China (66.3%), the Philippines (64.1%) and Latin America (62.8%) compared to Europe and North America (range 32.8% to 49.6%). The rate of cardiovascular death/heart failure hospitalization was higher in Asia (e.g. Taiwan 17.2, China 14.9 per 100 patient-years) than in Western Europe (10.4) and North America (12.8). However, the adjusted risk of cardiovascular death was higher in many Asian countries than in Western Europe (except Japan) and the risk of heart failure hospitalization was lower in India and in the Philippines than in Western Europe, but significantly higher in China, Japan, and Taiwan. CONCLUSION: Patient characteristics and outcomes vary between Asia and other regions and between Asian countries. These variations may reflect several factors, including geography, climate and environment, diet and lifestyle, health care systems, genetics and socioeconomic influences.

Blackstone, E. H., H. L. Chang, J. Rajeswaran, M. K. Parides, H. Ishwaran, L. Li, J. Ehrlinger, A. C. Gelijns, A. J. Moskowitz, M. Argenziano, J. J. DeRose, Jr., J. P. Couderc, D. Balda, F. Dagenais, M. J. Mack, G. Ailawadi, P. K. Smith, M. A. Acker, P. T. O’Gara and A. M. Gillinov (2019). “Biatrial maze procedure versus pulmonary vein isolation for atrial fibrillation during mitral valve surgery: New analytical approaches and end points.” J Thorac Cardiovasc Surg 157(1): 234-243.e239.

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OBJECTIVE: To use novel statistical methods for analyzing the effect of lesion set on (long-standing) persistent atrial fibrillation (AF) in the Cardiothoracic Surgical Trials Network trial of surgical ablation during mitral valve surgery (MVS). METHODS: Two hundred sixty such patients were randomized to MVS + surgical ablation or MVS alone. Ablation was randomized between pulmonary vein isolation and biatrial maze. During 12 months postsurgery, 228 patients (88%) submitted 7949 transtelephonic monitoring (TTM) recordings, analyzed for AF, atrial flutter (AFL), or atrial tachycardia (AT). As previously reported, more ablation than MVS-alone patients were free of AF or AF/AFL at 6 and 12 months (63% vs 29%; P < .001) by 72-hour Holter monitoring, without evident difference between lesion sets (for which the trial was underpowered). RESULTS: Estimated freedom from AF/AFL/AT on any transmission trended higher after biatrial maze than pulmonary vein isolation (odds ratio, 2.31; 95% confidence interval, 0.95-5.65; P = .07) 3 to 12 months postsurgery; estimated AF/AFL/AT load (ie, proportion of TTM strips recording AF/AFL/AT) was similar (odds ratio, 0.90; 95% confidence interval, 0.57-1.43; P = .6). Within 12 months, estimated prevalence of AF/AFL/AT by TTM was 58% after MVS alone, and 36% versus 23% after pulmonary vein isolation versus biatrial maze (P < .02). CONCLUSIONS: Statistical modeling using TTM recordings after MVS in patients with (long-standing) persistent AF suggests that a biatrial maze is associated with lower AF/AFL/AT prevalence, but not a lower load, compared with pulmonary vein isolation. The discrepancy between AF/AFL/AT prevalence assessed at 2 time points by Holter monitoring versus weekly TTM suggests the need for a confirmatory trial, reassessment of definitions for failure after ablation, and validation of statistical methods for assessing atrial rhythms longitudinally.

Ailawadi, G., D. S. Lim, M. J. Mack, A. Trento, S. Kar, P. A. Grayburn, D. D. Glower, A. Wang, E. Foster, A. Qasim, N. J. Weissman, J. Ellis, L. Crosson, F. Fan, I. L. Kron, P. J. Pearson and T. Feldman (2019). “One-Year Outcomes After MitraClip for Functional Mitral Regurgitation.” Circulation 139(1): 37-47.

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BACKGROUND: Secondary mitral regurgitation (SMR) occurs in the absence of organic mitral valve disease and may develop as the left ventricle dilates or remodels or as a result of leaflet tethering with impaired coaptation, most commonly from apical and lateral distraction of the subvalvular apparatus, with late annular dilatation. The optimal therapy for SMR is unclear. This study sought to evaluate the 1-year adjudicated outcomes of all patients with SMR undergoing the MitraClip procedure in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) Investigational Device Exemption program, which is comprised of the randomized clinical trial, the prospective High-Risk Registry, and the REALISM Continued Access Registry (Multicenter Study of the MitraClip System). METHODS: Patients with 3+/4+ SMR enrolled in EVEREST II were stratified by non-high surgical risk (non-HR) and high surgical risk (HR) status (defined as Society of Thoracic Surgeons risk of mortality >/=12% or predefined risk factors). Clinical, echocardiographic, and functional outcomes at 1 year were evaluated. RESULTS: A total of 616 patients (482 HR, 134 non-HR; mean age, 73.3+/-10.5 years; Society of Thoracic Surgeons risk, 10.2+/-6.9%) with SMR underwent the MitraClip procedure. At baseline, 80.5% of patients were in New York Heart Association class III/IV. Major adverse events at 30 days included death (3.6%), stroke (2.3%), and renal failure (1.5%). At discharge, 88.8% had MR

Arnold, S. V., Z. Li, S. Vemulapalli, S. J. Baron, M. J. Mack, A. S. Kosinski, M. R. Reynolds, J. B. Hermiller, J. S. Rumsfeld and D. J. Cohen (2018). “Association of Transcatheter Mitral Valve Repair With Quality of Life Outcomes at 30 Days and 1 Year: Analysis of the Transcatheter Valve Therapy Registry.” JAMA Cardiol Nov 21. [Epub ahead of print].

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Importance: Improvements in symptoms, functional capacity, and quality of life are among the key goals of edge-to-edge transcatheter mitral valve repair (TMVR) for mitral regurgitation. Objective: To examine health status outcomes among patients undergoing TMVR in clinical practice and the factors associated with improvement. Design, Setting, and Participants: This cohort study used the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, which contains data on patients with severe mitral regurgitation treated with TMVR from 2013 through 2017 in 217 US hospitals. Main Outcomes and Measures: Change in disease-specific health status (Kansas City Cardiomyopathy Questionnaire-Overall Summary score [KCCQ-OS]; range 0-100 points, with higher scores indicating better health status) at 30 days and 1 year after TMVR. We also examined factors associated with health status at 30 days after TMVR, by means of multivariable linear regression using a generalized estimating equations approach to account for clustering of patients within sites. Results: The KCCQ data were available in 81.2% at baseline, 69.3% of survivors at 30 days, and 47.4% of survivors at 1 year. Among 4226 patients who underwent TMVR, survived 30 days, and completed the KCCQ at baseline and follow-up, the KCCQ-OS increased from 41.9 before TMVR to 66.7 at 30 days (mean change 24.8 [95% CI, 24.0-25.6] points; P < .001), representing a large clinical improvement. The KCCQ scores remained stable from 30 days to 1 year after TMVR, with no further significant increase or decline. On multivariable analysis, atrial fibrillation (-2.2 [95% CI, -3.7 to -0.6] points; P = .01), permanent pacemaker (-2.1 [95% CI, -3.7 to -0.4] points; P = .01), severe lung disease (-3.9 [95% CI, -6.2 to -1.5] points; P = .001), home oxygen (-2.7 [95% CI, -4.9 to -0.4] points; P = .02), and lower KCCQ scores at baseline (3.9 points for each 10-point increase [95% CI, 3.6-4.2]; P < .001) were independently associated with lower 30-day KCCQ-OS scores. In-hospital renal failure was uncommon but was also associated with significant reductions in 30-day KCCQ-OS scores (-7.3 [95% CI -13.3 to -1.2] points). In estimates calculated with inverse probability weighting, after 1 year after TMVR, 54.2% (95% CI 52.2%-56.1%) of patients were alive and well; 23.0% had died, 21.9% had persistently poor health status (KCCQ-OS <60 points), 5.5% had a health status decline from baseline, and 4.6% had both poor health status and health status decline. Conclusions and Relevance: In a national cohort of US patients undergoing edge-to-edge TMVR in clinical practice, health status was impaired prior to the procedure, improved within 30 days, and remained stable through 1 year among surviving patients with available data. While long-term mortality remains high, most surviving patients demonstrate improvements in symptoms, functional status, and quality of life, with only modest differences by patient-level factors.

Shutze, W. P., Sr., R. Shutze, P. Dhot, M. Forge, A. Salazar and G. O. Ogola (2018). “Sex as an independent risk factor for long-term survival after endovascular aneurysm repair.” J Vasc Surg Nov 26. [Epub ahead of print].

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BACKGROUND: Several vascular surgical procedures, including repair of abdominal aortic aneurysms (AAAs), show poorer outcomes for women than for men. We evaluated the impact of sex-based demographic differences on survival after endovascular aneurysm repair (EVAR). METHODS: We reviewed EVARs performed at our institution between 2003 and 2009 and assessed aortic neck variables (length, diameter, angulation, and calcification), iliac artery variables (length, tortuosity, angulation, and calcification), and AAA diameter. Cox proportional hazards models were used to examine the association between sex and 5-year mortality while adjusting for patients’ demographics, comorbidities, anatomic variables, and AAA parameters. The final model adjusted for sex, age, body mass index, hypertension, iliac artery length, and aortic neck length. RESULTS: Of 336 patients, 278 were male (mean age, 73 years) and 58 were female (mean age, 77 years; P = .0005). Men had more coronary artery bypass grafts (79 vs 8; P = .02) and percutaneous coronary interventions (52 vs 4; P = .03) than women did. Significant differences between the sexes was seen for aortic neck angle, diameter, and length and for iliac artery diameter and length. Men (44%) were more likely than women (22%; P = .0002) to have EVAR performed within the device guidelines. Five-year survival was 73% in men and 49% in women. Multivariable analysis showed that female sex, increase in age, low body mass index (<25 kg/m(2)), and aortic neck length were significantly associated with risk of 5-year mortality. CONCLUSIONS: Women presented at an older age and with a more hostile anatomy. They had reduced survival compared with men after EVAR. After controlling for comorbidities and aortic neck and iliac artery anatomy, sex remained an independent predictor for survival.