Cardiology

Kron, I. L., D. J. LaPar, M. A. Acker, D. H. Adams, G. Ailawadi, S. F. Bolling, J. W. Hung, D. S. Lim, M. J. Mack, P. T. O’Gara, M. K. Parides and J. D. Puskas (2017). “2016 update to the american association for thoracic surgery (aats) consensus guidelines: Ischemic mitral valve regurgitation.” J Thorac Cardiovasc Surg 153(5): e97-e114.

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The objective of this project was to provide an update to the previously published consensus 2015 The American Association for Thoracic Surgery (AATS) evidence-based guidelines for the management of ischemic mitral regurgitation (IMR).

O’Hair, D. P., T. K. Bajwa, S. J. Chetcuti, G. M. Deeb, R. C. Stoler, R. F. Hebeler, B. Maini, M. Mumtaz, N. S. Kleiman, M. J. Reardon, S. Li, D. H. Adams, D. R. Watson, S. J. Yakubov, J. J. Popma and G. Petrossian (2017). “One-year outcomes of transcatheter aortic valve replacement in patients with end-stage renal disease.” Ann Thorac Surg 103(5): 1392-1398.

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BACKGROUND: End-stage renal disease (ESRD) poses unique challenges in the treatment of patients with severe aortic stenosis. Although surgical valve replacement in ESRD patients has been associated with increased mortality, the outcomes from transcatheter aortic valve replacement (TAVR) are not clearly defined. METHODS: The CoreValve US Expanded Use Study is a prospective, nonrandomized study of TAVR in extreme-risk patients with comorbidities excluding them from the Pivotal Trial. We report on patients with ESRD. The primary endpoint was a composite of all-cause mortality or major stroke at 1 year. RESULTS: Ninety-six patients with ESRD underwent TAVR with the CoreValve (Medtronic, Minneapolis, MN) and have reached 1-year follow-up. Mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 16.2% +/- 8.4%. The rate of all-cause mortality or major stroke at 1 year was 30.3%. The all-cause mortality rate was 5.3% at 30 days and 30.3% at 1 year. The rate at 1 year of any stroke or transient ischemic attack was 2.1%; major vascular injury was 5.2%; and new permanent pacemaker was 26.8%. Valve performance improved postprocedure and remained improved at 1 year (effective orifice area 1.71 cm2, mean gradient 9.33 mm Hg) CONCLUSIONS: Early mortality in patients with ESRD is comparable to previously published data on extreme-risk patients without ESRD, but our data suggest a higher mortality rate at 1 year for ESRD patients, likely due to comorbid conditions. Stroke and major vascular injury are infrequent, and improved valve hemodynamics are maintained at 1 year.

Kron, I. L., D. J. LaPar, M. A. Acker, D. H. Adams, G. Ailawadi, S. F. Bolling, J. W. Hung, D. S. Lim, M. J. Mack, P. T. O’Gara, M. K. Parides and J. D. Puskas (2017). “2016 update to the american association for thoracic surgery consensus guidelines: Ischemic mitral valve regurgitation.” J Thorac Cardiovasc Surg 153(5): 1076-1079.

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We are very pleased to update The American Association for Thoracic Surgery (AATS) Consensus Guidelines on ischemic mitral valve regurgitation (IMR) (Figure 1). These Guidelines were developed based on the results of published randomized clinical trials, large observational studies, and the expert opinion of the authors. Subsequent to the publication of the 2015 AATS IMR Guidelines,1 the 2-year follow-up results of the Cardiothoracic Surgical Trials Network (CTSN) severe and moderate ischemic mitral regurgitation (MR) trials were published.2,3

Packer, M., J. J. V. McMurray, H. Krum, W. Kiowski, B. M. Massie, A. Caspi, C. M. Pratt, M. C. Petrie, D. DeMets, I. Kobrin, S. Roux and K. Swedberg (2017). “Long-term effect of endothelin receptor antagonism with bosentan on the morbidity and mortality of patients with severe chronic heart failure: Primary results of the enable trials.” JACC Heart Fail 5(5): 317-326.

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OBJECTIVES: The objective of this clinical trial was to evaluate the long-term effect of endothelin receptor antagonism with bosentan on the morbidity and mortality of patients with severe chronic heart failure. BACKGROUND: Endothelin may play a role in heart failure, but short-term clinical trials with endothelin receptor antagonists have reported disappointing results. Long-term trials are lacking. METHODS: In 2 identical double-blind trials, we randomly assigned 1,613 patients with New York Heart Association functional class IIIb to IV heart failure and an ejection fraction <35% to receive placebo or bosentan (target dose 125 mg twice daily) for a median of 1.5 years. The primary outcome for each trial was clinical status at 9 months (assessed by the hierarchical clinical composite); the primary outcome across the 2 trials was death from any cause or hospitalization for heart failure. RESULTS: Bosentan did not influence clinical status at 9 months in either trial (p = 0.928 and p = 0.263). In addition, 321 patients in the placebo group and 312 patients in the bosentan group died or were hospitalized for heart failure (hazard ratio [HR]: 1.01; 95% confidence interval [CI]: 0.86 to 1.18; p = 0.90). The bosentan group experienced fluid retention within the first 2 to 4 weeks, as evidenced by increased peripheral edema, weight gain, decreases in hemoglobin, and an increased risk of hospitalization for heart failure, despite intensification of background diuretics. During follow-up, 173 patients died in the placebo group and 160 patients died in the bosentan group (HR: 0.94; 95% CI: 0.75 to 1.16). About 10% of the bosentan group showed meaningful increases in hepatic transaminases, but none had acute or chronic liver failure. CONCLUSIONS: Bosentan did not improve the clinical course or natural history of patients with severe chronic heart failure and but caused early and important fluid retention.

Blanke, P., P. Pibarot, R. Hahn, N. Weissman, S. Kodali, V. Thourani, R. Parvataneni, D. Dvir, C. Naoum, B. L. Norgaard, P. Douglas, W. Jaber, O. K. Khalique, H. Jilaihawi, M. Mack, C. Smith, M. Leon, J. Webb and J. Leipsic (2017). “Computed tomography-based oversizing degrees and incidence of paravalvular regurgitation of a new generation transcatheter heart valve.” JACC Cardiovasc Interv 10(8): 810-820.

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OBJECTIVES: The aim of the study was to investigate the influence of the extent of computed tomography (CT)-based area and perimeter oversizing on the incidence and severity of paravalvular aortic regurgitation (PAR) for the Edwards SAPIEN 3 (Edwards Lifesciences, Irvine, California) device, using CT data and echocardiographic outcome data of the PARTNER II (Placement of AoRTic TraNscathetER Valves Trial II) SAPIEN 3 intermediate-risk cohort. BACKGROUND: Transcatheter heart valve (THV) sizing algorithms are device specific, requiring refinements for new valve designs. METHODS: A total of 835 intermediate-risk patients with severe, symptomatic aortic stenosis enrolled in a multicenter, nonrandomized registry at 57 sites in the United States and Canada with available systolic CT data and echocardiographic follow-up were included in this analysis. THV size selection was primarily CT guided based on annular area. Area-based and perimeter-based oversizing was calculated using systolic annular CT dimensions and nominal dimensions of the implanted THV size. PAR was assessed at 30 days according to a 5-class scheme. RESULTS: Mean oversizing by area was 7.7 +/- 9.4% and mean oversizing by perimeter was 1.7 +/- 4.4%. An inverse proportional relationship between degree of oversizing and frequency and severity of PAR was observed for both area and perimeter oversizing. Perimeter and area oversizing confer similar predictive capacity in regard to the occurrence of PAR after THV implantation (area under the curve: 0.78 [95% confidence interval: 0.70 to 0.85] vs. area under the curve: 0.78 [95% confidence interval: 0.72 to 0.85]; p < 0.0001). No aortic root ruptures were observed. CONCLUSIONS: For the SAPIEN 3 THV, the frequency and extent of PAR is inversely related to the degree of oversizing with acceptable rates of PAR being achieved at lower degrees of oversizing. Perimeter and area oversizing confer similar predictive capacity in regard to the occurrence of PAR after implantation of the SAPIEN 3 THV. Therefore, the SAPIEN 3 THV may offer the opportunity to reduce the risk of annular rupture associated with more significant degrees of oversizing in borderline annular anatomy.