J. Michael DiMaio M.D.

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.

Lee, A. Y., K. M. Tecson, B. Lima, A. F. Shaikh, J. Collier, S. Still, R. Baxter, J. M. DiMaio, J. Felius, S. A. Carey, G. V. Gonzalez-Stawinski, R. Nauret, M. Wong, S. A. Hall and S. M. Joseph (2018). “Durable Left Ventricular Assist Device Implantation in Extremely Obese Heart Failure Patients.” Artif Organs Oct 25. [Epub ahead of print].

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BACKGROUND: Left ventricular assist devices (LVADs) have improved clinical outcomes and quality of life for those with end-stage heart failure. However, the costs and risks associated with these devices necessitate appropriate patient selection. LVAD candidates are becoming increasingly more obese and there are conflicting reports regarding obesity’s effect on outcomes. Hence, we sought to evaluate the impact of extreme obesity on clinical outcomes after LVAD placement. METHODS: Consecutive LVAD implantation patients at our center from June 2008- May 2016 were studied retrospectively. We compared patients with a body mass index (BMI) >/=40 kg/m(2) (extremely obese) to those with BMI <40 kg/m(2) with respect to patient characteristics and surgical outcomes, including survival. RESULTS: 252 patients were included in this analysis, 30 (11.9%) of whom met the definition of extreme obesity. We found that patients with extreme obesity were significantly younger (47[33, 57] v. 60[52, 67] years, p<0.001) with fewer prior sternotomies (16.7% v. 36.0%, p=0.04). They had higher rates of pump thrombosis (30% vs 9.0%, p=0.003) and stage 2/3 acute kidney injury (46.7% vs 27.0%, p=0.003), but there were no differences in 30-day or 1-year survival, even after adjusting for age and clinical factors. CONCLUSION: Extreme obesity does not appear to place LVAD implantation patients at a higher risk for mortality compared to those who are not extremely obese; however, extreme obesity was associated with an increased risk of pump thrombosis, suggesting that these patients may require additional care to reduce the need for urgent device exchange. This article is protected by copyright. All rights reserved.

Squiers, J. J. and J. M. DiMaio (2018). “Don’t change the guidelines yet, randomized data on surgical left atrial appendage closure is on the horizon.” J Thorac Cardiovasc Surg 156(3): 1081-1082.

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This meta-analysis demonstrates clear short-term benefits to surgical LAA closure. Ongoing RCTs will most likely determine the future of clinical practice. Atrial fibrillation (AF) remains the most common rhythm disorder of clinical significance and one of the leading causes of cardiogenic ischemic events. The most common anatomic source of thrombus in patients with AF is the left atrial appendage (LAA). Greater than 10% of patients undergoing cardiac surgery have been diagnosed with AF preoperatively, so surgeons have naturally had long-standing interest in LAA interventions that might reduce the risk of stroke. Unfortunately, the data currently available to support routine surgical LAA occlusion present a mixed picture, even to the most optimistic surgeon. Ando and colleagues are to be congratulated on their exhaustive systematic review of the literature to gather the best data on surgical LAA occlusion and to determine its short-term (30-day or in-hospital) effectiveness regarding prevention of mortality and stroke via meta-analysis. The authors identified 3 randomized controlled trials (RCTs) and 4 adjusted retrospective studies for inclusion, although only 3 studies (totaling 2464 patients) contributed to the mortality end point and 6 studies (3846 patients) contributed to the stroke end point because of limitations in data extraction from the original publications. The meta-analysis demonstrated that surgical LAA occlusion was associated with a reduction in mortality (odds ratio, 0.384; 95% confidence interval, 0.233-0.631) and stroke (odds ratio, 0.622; 95% confidence interval, 0.388-0.988), with further sub-analyses identifying a particularly strong benefit in patients with preoperative AF and possibly with those undergoing valve interventions as well. Should not such clear-cut results have the guideline writers running to their desks with pencils sharpened to draft an update regarding surgical LAA closure? Not so fast because, despite its many strengths, this analysis has several important limitations. (Excerpt from commentary on Masahiko Ando et al., Concomitant surgical closure of left atrial appendage: A systematic review and meta-analysis,The Journal of Thoracic and Cardiovascular Surgery, Volume 156, Issue 3, September 2018, Pages 1071-1080.)

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.

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 Jul 23. [Epub ahead of print].

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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 4 markers (gait speed, handgrip 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 Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM), frailty, and/or sarcopenia metrics for predicting 1-year mortality was assessed with area under the curve, Hosmer-Lemeshow statistics, and calibration plots. RESULTS: A total of 63 (13.4%) deaths occurred by 1-year. STS-PROM alone was poorly predictive of 1-year mortality (AUC 0.52, 95%CI: 0.42, 0.68). Only the model including both sarcopenia and all frailty markers (AUC 0.61, 95%CI: 0.53, 0.68) significantly improved predictive ability compared to STS-PROM 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 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 following TAVR.