David L. Brown M.D.

Durko, A. P., M. J. Reardon, N. S. Kleiman, J. J. Popma, N. M. Van Mieghem, T. G. Gleason, T. Bajwa, D. O’Hair, D. L. Brown, W. H. Ryan, Y. Chang, S. D. De Leon and A. P. Kappetein (2018). “Neurological Complications After Transcatheter Versus Surgical Aortic Valve Replacement in Intermediate-Risk Patients.” J Am Coll Cardiol 72(18): 2109-2119.

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BACKGROUND: Neurological events after aortic valve interventions are associated with increased mortality and morbidity. Transcatheter aortic valve replacement (TAVR) is increasingly offered for lower-risk patients with severe aortic stenosis, previously considered candidates for surgical aortic valve replacement (SAVR). Differences in post-procedural neurological events have important implications in treatment allocation. OBJECTIVES: The authors sought to analyze the neurological events in the randomized SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial. METHODS: Patients with severe, symptomatic aortic stenosis at intermediate surgical risk were randomized 1:1 to TAVR or SAVR. The rates of neurological events and quality of life were analyzed at 30 days, and 6 and 12 months post-procedure in a modified intention-to-treat population (mean age 79.8 +/- 6.2 years; N = 1,660). RESULTS: The rates of early (30-day) stroke and post-procedural encephalopathy were higher after SAVR versus TAVR (5.4% vs. 3.3%; p = 0.031; and 7.8% vs. 1.6%; p < 0.001, respectively). At 12 months, the rate of stroke was not different between SAVR and TAVR (6.9% vs. 5.2%; p = 0.136). Early stroke and early encephalopathy resulted in an elevated mortality at 12 months in both treatment groups. Quality of life after an early stroke was significantly lower in SAVR versus TAVR patients at 30 days and was similar at 6 and 12 months. CONCLUSIONS: The early stroke rate was lower after TAVR than SAVR. In patients with early strokes, QOL improved earlier after TAVR. At 12-month follow-up, stroke rates and QOL were not different between TAVR and SAVR patients. (Surgical Replacement and Transcatheter Aortic Valve Implantation [SURTAVI]; NCT01586910).

Basra, S. S., A. Gopal, K. R. Hebeler, H. Baumgarten, A. Anderson, S. P. Potluri, W. T. Brinkman, M. Szerlip, D. Gopal, G. Filardo, J. M. DiMaio, D. L. Brown, P. A. Grayburn, M. J. Mack and E. M. Holper (2018). “Clinical Leaflet Thrombosis in Transcatheter and Surgical Bioprosthetic Aortic Valves by 4DCT.” Ann Thorac Surg. Aug 25. [Epub ahead of print].

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BACKGROUND: The incidence of leaflet thrombosis after transcatheter aortic valve replacement (TAVR) with active surveillance by 4- Dimensional Computed Tomography (4DCT) ranges from 7% to 14%. The incidence of leaflet thrombosis when 4DCT is performed for clinical and echocardiographic indications is unknown. METHODS: All patients with prior TAVR or surgical aortic valve replacement (SAVR) that underwent evaluation between 10/2015 – 1/2017 at our institution and had clinical or echocardiographic indications of leaflet thrombosis were evaluated by 4DCT. Indications for 4DCT included: A) Echocardiographic: 1) Interval increase in mean gradient >/=10 mmHg; 2) Interval decrease in ejection fraction (>/=10 percent) 3) Thrombus seen on TTE 4) Persistent or increasing paravalvular leak 4) Valve dehiscence or thickened leaflets seen on TTE; B) Clinical: 1) Stroke 2) TIA 3) New/worsening heart failure RESULTS: 612 patients underwent TAVR during the study period. 101 patients (55 TAVR; 46 SAVR) met the criteria for 4DCT imaging. Leaflet thrombosis was seen in 17/55 (30.9%) TAVR and 15/46 (32.6%) SAVR patients. Follow-up imaging with 4DCT after treatment with anticoagulation showed improvement/resolution in thrombus burden and leaflet excursion in all TAVR and 2/3rd SAVR patients. CONCLUSIONS: In patients with clinical or echocardiographic indications suggestive of leaflet thrombosis, 1/3rd of patients were found to have evidence of leaflet thrombosis using 4DCT. This allowed tailored anticoagulation therapy with resolution of the thrombus in most patients avoiding unnecessary anticoagulation in the remaining 2/3rds of patients.

Tecson, K. M., D. Brown, J. W. Choi, G. Feghali, G. V. Gonzalez-Stawinski, B. L. Hamman, R. Hebeler, S. R. Lander, B. Lima, S. Potluri, J. M. Schussler, R. C. Stoler, C. Velasco and P. A. McCullough (2018). “Major Adverse Renal and Cardiac Events After Coronary Angiography and Cardiac Surgery.” Ann Thorac Surg 105(6): 1724-1730.

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BACKGROUND: Patients at high risk for having postprocedural complications may receive iodixanol, an iso-osmolar contrast, during coronary angiography to minimize the risk of renal toxicity. For those who also require cardiac surgery, the wait time between angiography and surgery may be a modifiable factor capable of mitigating poor surgical outcomes; however, there have been inconsistent reports regarding the optimal wait time. We sought to determine the effects of wait time between angiography and cardiac surgery, as well as contrast-induced acute kidney injury on the development of major adverse renal and cardiac events (MARCE). METHODS: We merged datasets to identify adults who underwent coronary angiography with iodixanol and subsequent cardiac surgery. RESULTS: Of 965 patients, 126 (13.1%) had contrast-induced acute kidney injury; 133 (13.8%) had MARCE within 30 days and 253 (26.2%) within 1 year of surgery. After adjusting for contrast-induced acute kidney injury, age, and Thakar acute renal failure score, the effect of wait time lost significance for the full cohort, but remained for the subgroup of 654 who had coronary artery bypass graft surgery. Patients undergoing coronary artery bypass graft surgery within 1 day of coronary angiography had an approximate twofold increase in risk of MARCE (30-day hazard ratio 2.13, 95% confidence interval: 1.16 to 3.88, p = 0.014; 1-year hazard ratio 2.07, 95% confidence interval: 1.32 to 3.23, p = 0.002) compared with patients who waited 5 or more days. CONCLUSIONS: Patients who had contrast-induced acute kidney injury and had cardiac surgery within 1 day of angiography had an increased risk of MARCE.

Tecson, K. M., D. Brown, J. W. Choi, G. Feghali, G. V. Gonzalez-Stawinski, B. L. Hamman, R. Hebeler, S. R. Lander, B. Lima, S. Potluri, J. M. Schussler, R. C. Stoler, C. Velasco and P. A. McCullough (2018). “Major Adverse Renal and Cardiac Events Following Coronary Angiography and Cardiac Surgery.” Ann Thorac Surg. Feb 2. [Epub ahead of print].

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BACKGROUND: Patients at high risk for developing post-procedural complications may receive iodixanol, an iso-osmolar contrast, during coronary angiography to minimize the risk of renal toxicity. For those who additionally require cardiac surgery, the wait-time between angiography and surgery may be a modifiable factor capable of mitigating poor surgical outcomes; however, there have been inconsistsent reports regarding the optimal wait-time. We sought to determine the effects of wait time between angiogram and cardiac surgery, as well as contrast induced acute injury (CI-AKI) on the development of major adverse renal and cardiac events (MARCE). METHODS: We merged datasets to identify adults who underwent coronary angiography with iodixanol and subsequent cardiac surgery. RESULTS: Of 965 patients, 126 (13.1%) developed CI-AKI; 133 (13.8%) experienced MARCE within 30 days and 253 (26.2%) within 1 year of surgery. After adjusting for CI-AKI, age, and Thakar acute renal failure score, the effect of wait-time lost significance for the full cohort, but remained for the 654 who had coronary artery bypass grafting. Those with coronary artery bypass grafting within 1 day of coronary angiography had an approximate 2-fold increase in risk of MARCE (30-day hazard ratio =2.13, 95% confidence interval 1.16-3.88, p=0.014; 1-year hazard ratio =2.07, 95% confidence interval 1.32, 3.23, p = 0.002) compared to those who waited 5 or more days. CONCLUSIONS: Patients who suffered CI-AKI and had cardiac surgery within 1 day of angiography had increased risk of MARCE.

Baron, S. J., S. V. Arnold, K. Wang, E. A. Magnuson, K. Chinnakondepali, R. Makkar, H. C. Herrmann, S. Kodali, V. H. Thourani, S. Kapadia, L. Svensson, D. L. Brown, M. J. Mack, C. R. Smith, M. B. Leon and D. J. Cohen (2017). “Health status benefits of transcatheter vs surgical aortic valve replacement in patients with severe aortic stenosis at intermediate surgical risk: Results from the partner 2 randomized clinical trial.” JAMA Cardiol: 2017 Jun [Epub ahead of print].

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Importance: In patients with severe aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) results in similar 2-year survival. The effect of TAVR vs SAVR on health status in patients at intermediate surgical risk is unknown. Objective: To compare health-related quality of life among intermediate-risk patients with severe AS treated with either TAVR or SAVR. Design, Setting, and Participants: Between December 2011 and November 2013, 2032 intermediate-risk patients with severe AS were randomized to TAVR with the Sapien XT valve or SAVR in the Placement of Aortic Transcatheter Valve 2 Trial and were followed up for 2 years. Data analysis was conducted between March 1, 2016, to April 30, 2017. Main Outcomes and Measures: Health status was assessed at baseline, 1 month, 1 year, and 2 years using the Kansas City Cardiomyopathy Questionnaire (KCCQ) (23 items covering physical function, social function, symptoms, self-efficacy and knowledge, and quality of life on a 0- to 100-point scale; higher scores indicate better quality of life), Medical Outcomes Study Short Form-36 (36 items covering 8 dimensions of health status as well as physical and mental summary scores; higher scores represent better health status), and EuroQOL-5D (assesses 5 dimensions of general health on a 3-level scale, with utility scores ranging from 0 [death] to 1 [ideal health]). Analysis of covariance was used to examine changes in health status over time, adjusting for baseline status. Results: Of the 2032 randomized patients, baseline health status was available for 1833 individuals (950 TAVR, 883 SAVR) who formed the primary analytic cohort. A total of 1006 (54.9%) of the population were men; mean (SD) age was 81.4 (6.8) years. Over 2 years, both TAVR and SAVR were associated with significant improvements in both disease specific (16-22 points on the KCCQ-OS scale) and generic health status (3.9-5.1 points on the SF-36 physical summary scale). At 1 month, TAVR was associated with better health status than SAVR, but this difference was restricted to patients treated via transfemoral access (mean difference in the KCCQ overall summary [KCCQ-OS] score, 14.1 points; 95% CI, 11.7 to 16.4; P < .01) and was not seen in patients treated via transthoracic access (mean difference in KCCQ-OS, 3.5 points; 95% CI, -1.4 to 8.4; P < .01 for interaction). There were no significant differences between TAVR and SAVR in any health status measures at 1 or 2 years. Conclusions and Relevance: Among intermediate-risk patients with severe AS, health status improved significantly with both TAVR and SAVR through 2 years of follow up. Early health status improvement was greater with TAVR, but only among patients treated via transfemoral access. Longer term follow-up is needed to assess the durability of quality-of-life improvement with TAVR vs SAVR in this population.