Cardiology

Tjaden, B. L., Jr., H. Sandhu, C. Miller, D. Gable, S. Trimarchi, F. Weaver and A. Azizzadeh (2018). “Outcomes from the Gore Global Registry for Endovascular Aortic Treatment in patients undergoing thoracic endovascular aortic repair for type B dissection.” J Vasc Surg 68(5): 1314-1323.

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OBJECTIVE: The Global Registry for Endovascular Aortic Treatment (GREAT) is a prospective multicenter registry collecting real-world data on the performance of W. L. Gore (Flagstaff, Ariz) aortic endografts. The purpose of the present study was to analyze the implementation and outcomes of thoracic endovascular aortic repair (TEVAR) in GREAT patients with type B aortic dissection (TBAD). METHODS: From 2010 to 2016, >5000 patients were enrolled in the GREAT from 113 centers in 14 countries across 4 continents. The study population comprised those treated for TBAD. The primary outcomes of interest were mortality and freedom from aortic events (AEs). RESULTS: A total of 264 patients (80% male; mean age, 62 years) underwent TEVAR for the treatment of 170 (64%) acute and 94 (36%) chronic cases of TBAD. Chronic TBAD patients required significantly longer endograft coverage than did acute TBAD patients (P = .05). Early postoperative complications occurred in 9% of patients, with no difference in chronic vs acute dissection (P = .11). The 30-day aortic mortality and all-cause mortality were 1.5% and 2.3%, respectively, with no differences based on chronicity. During a mean follow-up of 26 months, the total aortic mortality was 2.7% and the total all-cause mortality was 12.5%. The all-cause mortality was significantly greater for chronic vs acute TBAD (19.2% vs 8.8%, respectively; P = .02). On multivariate analysis, patients with acute uncomplicated dissections had significantly improved overall survival compared with all other categories of dissections (93% vs 83% at 2 years; P < .05). A proximal landing zone diameter >40 mm was associated with an increased risk of retrograde type A dissection (18% vs 2%; P = .02). Patients undergoing left subclavian artery (LSA) coverage experienced a twofold greater rate of AEs compared with noncoverage patients (P < .01). Patients who underwent LSA revascularization experienced a 1.5-fold greater rate of AEs compared with patients covered without revascularization (P = .04). CONCLUSIONS: TEVAR for TBAD using the conformable GORE TAG thoracic endoprosthesis device can be performed with a low incidence of aortic mortality and complications. Acute uncomplicated TBAD patients had a significantly lower mortality rate than that of other patients. Larger proximal landing zones were associated with more frequent retrograde type A dissection. LSA involvement (coverage and/or revascularization) was associated with an increased risk of AEs during follow-up.

Ramires, F. J. A., F. Martinez, E. A. Gomez, C. Demacq, C. R. Gimpelewicz, J. L. Rouleau, S. D. Solomon, K. Swedberg, M. R. Zile, M. Packer and J. J. V. McMurray (2018). “Commentary: Post hoc analyses of SHIFT and PARADIGM-HF highlight the importance of chronic Chagas’ cardiomyopathy.” ESC Heart Fail Oct 9. [Epub ahead of print].

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We read with interest the report by Bocchi and colleagues of their post hoc analysis of the Systolic Heart failure treatment with the If inhibitor ivabradine Trial (SHIFT), examining the effect of study drug in the 38 patients with chronic chagasic cardiomyopathy (CCC). The authors reported that study drug lowered heart rate and improved New York Heart Association class. The sample size was too small to allow estimation of the effect of treatment on mortality or hospitalization. However, this analysis did suggest that patients with CCC experienced high event rates, despite excellent background therapy. We examined outcomes in patients with CCC in the Prospective comparison of Angiotensin Receptor Neprilysin Inhibitor with Angiotensin Converting Enzyme Inhibitor to Determine Impact on Global Mortality and morbidity in Heart Failure (PARADIGM‐HF) and the Aliskiren trial to Minimize OutcomeS in Patients with Heart failure (ATMOSPHERE). These trials included 195 CCC patients from among a total of 2552 recruited in Latin America. Despite being younger and having less co‐morbidity, the CCC patients had higher hospitalization and mortality rates, compared with other aetiologies, despite similarly good treatment. We also conducted an exploratory post hoc analysis of the effect of sacubitril/valsartan (formerly known as LCZ696) in CCC patients in PARADIGM‐HF. Of a total of 113 patients, 58 were randomized to sacubitril/valsartan and 55 to enalapril. The two treatment groups were similar in terms of demographics, co‐morbidity, and heart failure (HF) severity. Patients with CCC treated with sacubitril/valsartan, as compared with enalapril, had a lower risk of experiencing cardiovascular death or HF hospitalization, the primary composite endpoint, and each of its components (Figure). The point estimate for risk reduction was comparable with or greater than that seen with the drug vs. enalapril in the entire study population. This analysis is underpowered and should be interpreted with caution. CCC is a major health issue in Latin America and is now recognized in the USA and Europe, reflecting contemporary migration patterns.5-8 Indeed, a recent study from Brazil concluded that the population attributable mortality risk from CCC increased between 2002/2004 and 2012/2014.9 Future trials should consider recruiting larger numbers of patients with CCC to allow adequately powered subgroup analysis and even trials specifically in CCC would be justified, given the magnitude of this problem. Until that time, patients with CCC should be treated empirically with therapies recommended by guidelines, on the assumption that treatments for patients with reduced ejection fraction are effective, irrespective of aetiology. (Text of letter concerning Bocchi. 2018. Safety profile and efficacy of ivabradine in heart failure due to Chagas heart disease: a post hoc analysis of the SHIFT trial.)

Mack, M. J. (2018). “Is TAVR Ready for Prime Time in Low-Risk Patients?” J Am Coll Cardiol 72(18): 2106-2108.

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Transcatheter aortic valve replacement (TAVR) has been demonstrated in randomized controlled trials (RCTs) to be superior to medical therapy in inoperable patients with severe symptomatic aortic stenosis and to be noninferior to surgical aortic valve replacement (SAVR) in high and intermediate surgical risk patients. TAVR has thus become widely accepted as the standard of care in these patient cohorts due in large part to the robust body of evidence generated by 6 RCTs. We also have some outcome data in low-risk patients from a single randomized trial, NOTION (Nordic Aortic Valve Intervention Trial; NCT01057173). There are 2 more RCTs comparing TAVR with SAVR in low surgical risk patients with 2 different devices that have now completed enrollment of approximately 2,000 patients, and the outcomes of these trials are expected to become available in early 2019 . . . With this background in mind, we now consider the study by Waksman et al. reported in this issue of the Journal. It is an observational, nonrandomized study of 200 low surgical risk patients with severe symptomatic aortic stenosis who underwent TAVR. The primary endpoint of the study is all-cause mortality at 30 days. Important exclusions included bicuspid aortic valves and unsuitability for transfemoral access. The mean age was 73.6 years, and the STS PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) was 1.8. A balloon-expandable valve, Sapien 3 (Edwards Lifesciences, Irvine, California), was used in 88.2% of the patients and a self-expanding valve, CoreValve Evolut R (Medtronic, Dublin, Ireland), in 11.8%. Notable procedural findings are that 75% of the procedures were performed without general anesthesia, all by transfemoral access, and there was 1 conversion to surgery due to coronary artery obstruction (0.5%). The 30-day results are excellent in that there was no mortality and a 0.5% stroke rate. Also of note is that there was a low incidence of the need for new permanent pacemaker implantation (5%) and a low rate of new-onset atrial fibrillation (3%), and there were 2 patients (1.0%) with a moderate-severe paravalvular leak at discharge. (Commentary on Waksman et al. 2018. Transcatheter aortic valve replacement in low-risk patients with symptomatic severe aortic stenosis. J Am Coll Cardiol, 72.)

Kilic, A., J. N. Katz, S. M. Joseph, M. A. Brisco-Bacik, N. Uriel, B. Lima, R. Agarwal, R. Bharmi, D. J. Farrar and S. Lee (2018). “Changes in pulmonary artery pressure before and after left ventricular assist device implantation in patients utilizing remote haemodynamic monitoring.” ESC Heart Fail Oct 23. [Epub ahead of print].

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AIMS: The time course of changes in pulmonary artery (PA) pressure due to left ventricular assist devices (LVADs) is not well understood. Here, we describe longitudinal haemodynamic trends during the peri-LVAD implantation period in patients previously implanted with a remote monitoring PA pressure sensor. METHODS AND RESULTS: We retrospectively studied PA pressure trends in patients implanted with CardioMEMS PA pressure sensor between October 2007 and March 2017 who subsequently had an LVAD procedure. Data are presented as mean +/- standard deviation, and P-values are calculated using standard t-test with equal variance. Among 436 patients in cohort, 108 (age 58 +/- 11 years, 82% male) received an LVAD and 328 (age 60 +/- 13 years, 70% male) did not. The mean PA pressure at sensor implant was higher by 29% (P < 0.001) among patients who later received LVAD. Mean PA pressure 6 months prior to LVAD implant was 35.5 +/- 8.5 mmHg, increasing to 39.4 +/- 9.9 mmHg (P = 0.04) at 4 weeks before LVAD, and then decreasing 27% to 28.8 +/- 8.4 mmHg (P < 0.001) at 3 months post-implant and stabilizing at 31.0 +/- 9.4 mmHg at 1 year. CONCLUSIONS: Patients who later receive LVADs have higher PA pressures at sensor implant and show a further increase leading up to LVAD implantation. There is a significant reduction of PA pressures post-LVAD implantation that persists long term. PA pressure monitoring may aid in the clinical decision making of timing for LVAD implantation and in management of LVAD patients.

Hebeler, K. R., H. Baumgarten, J. J. Squiers, J. Wooley, B. D. Pollock, C. Mahoney, G. Filardo, B. Lima and J. M. DiMaio (2018). “Albumin Is Predictive of 1-Year Mortality After Transcatheter Aortic Valve Replacement.” Ann Thorac Surg 106(5): 1302-1307.

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BACKGROUND: A validated model for predicting 1-year outcomes after transcatheter aortic valve replacement (TAVR) does not exist. TAVR-specific risk models may benefit from frailty markers, and sarcopenia may represent an objective frailty marker. This study assessed the predictive ability of sarcopenia and frailty markers on 1-year mortality after TAVR. METHODS: We evaluated 470 patients undergoing TAVR at a single center. Frailty was assessed using four markers: gait speed, hand grip strength, serum albumin, and Katz activities of daily living. Sarcopenia was measured as the cross-sectional psoas muscle area on pre-TAVR computed tomography. Performance of four models incorporating The Society of Thoracic Surgeons Predicted Risk of Mortality, frailty, or sarcopenia metrics, or both, for predicting 1-year mortality was assessed with area under the curve, Hosmer-Lemeshow statistics, and calibration plots. RESULTS: A total of 63 deaths (13.4%) deaths occurred by 1 year. The Society of Thoracic Surgeons Predicted Risk of Mortality alone was poorly predictive of 1-year mortality (area under the curve, 0.52; 95% confidence interval, 0.42 to 0.68). Only the model including sarcopenia and all frailty markers (area under the curve, 0.61; 95% confidence interval, 0.53 to 0.68) significantly improved predictive ability compared with The Society of Thoracic Surgeons Predicted Risk of Mortality alone (p = 0.05). Albumin was the only frailty marker significantly associated with increased risk for 1-year mortality (p = 0.03). Psoas muscle area, as a surrogate for sarcopenia, was not significantly associated with increased risk for 1-year mortality. CONCLUSIONS: Most of the commonly used pre-TAVR risk assessments are poorly predictive of 1-year mortality. Albumin was the only frailty marker that was associated with higher mortality. Future studies should investigate whether optimization of nutritional status can improve outcomes after TAVR.