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TCT-424 Brief Cognitive Behavioral Therapy for Patients Undergoing TAVR: A Randomized Controlled Trial
B174
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 70, NO. 18, SUPPL B, 2017
BACKGROUND Neurological events and brain infarction remain a concern after transcatheter aortic valve replacement (TAVR). While Cerebral Embolic Protection (CEP) devices provide meaningful protection, recent trials still showed substantial variability in individual outcomes. There remains a strong need to identify individual patient outcome predictors. Pre-existing white matter disease (T2-FLAIR positive lesion volume) may reflect overall susceptibility to cerebrovascular insults. In this context, we set out to determine whether preprocedural T2-FLAIR cerebral lesions are predictive of new brain infarction and/or neurological events after TAVR. METHODS Data from the SENTINEL trial was analyzed post hoc. Subjects were split into two groups, based on median baseline T2FLAIR lesion volume, and 30 day MACCE rates, stroke rates, and 27day post-TAVR new ischemic lesion (DWI) volumes were compared between groups. RESULTS A total of 228 subjects were included in the analysis, with a mean age of 83.1 (7.8). MACCE and stroke rates for the above-median T2-lesion volume group were numerically higher than the belowmedian group (10.5% vs. 5.3% for MACCE and 8.8% vs. 4.4% for stroke), but the differences did not reach significance. In contrast, median post-TAVR new ischemic lesion volume was more than twice as large in those with high baseline T2 lesion volume (479.9 mm3 vs. 197.8 mm3), and the difference was highly significant (p<0.001). CONCLUSION Pre-existing T2- FLAIR lesion burden strongly predicts new procedure-related DWI lesion volume in TAVR, and should be included as a covariate when using that endpoint in studies. Its relationship with MACCE and stroke rates is less clear, and needs further study in larger cohorts. CATEGORIES ENDOVASCULAR: Stroke and Stroke Prevention TCT-423 Is there a difference in cerebral infarcts in patients who undergo TAVR for calcified aortic valve stenosis compared to pure aortic regurgitation? Ermela Yzeiraj,1 Timo Haselbach,2 Julian Witt,3 Klaudija Bijuklic,1 Lorenz Hansen,2 Friedrich-Christian Rieß,4 Joachim Schofer5 1 Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg, Germany; 2 Albertinen Krankenhaus, Hamburg, Germany; 3Albertinen Krankenhaus Hamburg, Hamburg, Germany; 4Albertinen Heart Center, Hamburg, Germany, Hamburg, Germany; 5Medical Care Center Prof. Mathey, Prof. Schofer and Albertinen Heart Center, Hamburg, Hamburg, Germany BACKGROUND Transcatheter aortic valve replacement (TAVR) is associated with the risk of symptomatic or silent cerebral infarcts (CIs). The role of aortic valve calcification on CIs is not well known. The purpose of this study was to investigate the impact of aortic valve complex calcification on CIs in patients with a wide range of calcification undergoing TAVR using a retrievable prosthesis and to identify predictors of CIs. METHODS One hundred and nine consecutive patients who underwent transfemoral TAVR using the Direct Flow Medical (DFM, Santa Rosa, California) prosthesis and received a cerebral DW-MRI 3-5 day after TAVR, were included in the study. Volumetric quantification of aortic valve complex calcification was performed from pre-procedural multislice computed tomography. RESULTS Out of 109 patients, 102 (93.6) had severe calcified aortic valve stenosis (AVS) and 7 patients (6.4%) had pure aortic regurgitation (AR). Aortic valve complex calcium in patients with AVS was 290 mm3 and in patients with AR 12 mm3 (p¼0.009). New CIs were found in 78% of patients. The incidence of CIs was comparable between patients with AVS and patients with pure AR (77.5% versus 85.7%, p¼1.000) whereas the number of new CIs per patient was significantly higher in the pure AR group (median 4 (IQR 3-13) versus 2 (IQR 1-5), p¼0.001). The same was true for total lesion volume per patient (280 mm3 (241-2319) in patients with pure AR versus 148 mm3 (18-368) in patients with AVS, p¼0.013). In the multivariate logistic regression analysis no independent predictor for new CIs could be identified. CONCLUSION Patients with calcified AVS undergoing TAVI do not have a higher incidence of CIs compared to patients with pure AR. Surprisingly, patients with pure AR had higher lesion number and volume per patient. Aortic valve calcification was not correlated with CIs. Further studies are needed to better understand the mechanism of CIs and address the use of cerebral protection devices during TAVR procedure. CATEGORIES STRUCTURAL: Valvular Disease: Aortic
TCT-424 Brief Cognitive Behavioral Therapy for Patients Undergoing TAVR: A Randomized Controlled Trial Katharine Edwards,1 Derik Hossepian,2 Audrey Johnson,2 Catherine Dao,3 Sonia Shah,4 William Fearon5 1 Stanford University, Stanford, CA, California, United States; 2Palo Alto University, Palo Alto, California, United States; 3Washington Township Medical Foundation, Fremont, California, United States; 4Stanford University, Stanford, California, United States; 5Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, California, United States BACKGROUND Depression occurs in 15-40% of cardiac surgery patients and has been associated with cardiac morbidity, re-hospitalization, decreased functional status, and lower quality of life (QOL). Cognitive behavioral therapy (CBT) is an effective, evidence-based treatment for depression and anxiety. Preliminary studies have shown transcatheter aortic valve replacement (TAVR) to benefit physical function and QOL, with modest gains in mental health compared to standard therapy. However, to date no published trials have looked at the impact of treating depression or anxiety in these patients. METHODS Of 129 patients consented for mental health screening prior to TAVR, 44 (34%) endorsed clinically significant anxiety or depression at baseline. Patients were randomized to brief bedside CBT delivered during their hospital stay (n¼25) or treatment as usual control (n¼19). Self-report measures for depression (Beck Depression Inventory-II) and QOL (Minnesota Living with Heart Failure Questionnaire) were administered again at discharge and 1-month follow up. RESULTS Despite randomization, baseline depression scores were not equivalent between groups (F¼4.45, p<0.05) and standard ANOVA comparisons were non-significant. However, mean change on the BDIII from baseline to 1-month follow up was clinically significant for the CBT group (D¼-6.78) but not the control group (D¼-4.75) and change scores from baseline to 1-month follow up were greater for the CBT group (D¼-2.85) than the control group (D¼-0.54; t¼-1.54, p¼0.05). Mean change in QOL as measured by the MLHFQ was moderately-tomarkedly improved in the CBT group (D¼19.21) vs. mildly improved in the control group (D¼13.54). CONCLUSION Previous studies have established that brief CBT targeting post-operative depression and anxiety are feasibly and acceptable for patients undergoing CABG surgery. This is the first study to examine a similar intervention for TAVR patients, and data suggest that brief CBT is a promising intervention for improving mood and QOL post discharge. Additional findings will be presented regarding health care utilization and predictors of post-operative depression and anxiety. CATEGORIES STRUCTURAL: Valvular Disease: Aortic TCT-425 Impact of cerebral protection in aortic stenosis patients treated with transcatheter aortic valve replacement on functional and structural integrity of the brain: results of a combined patient-level analysis of three randomized controlled trials Axel Linke,1 Samir Kapadia,2 Susheel Kodali,3 Raj Makkar,4 Maria Alu,5 Peyton Willert,6 Michael Dwyer,7 Robert Zivadinov,8 Lisa Thackeray,9 Roseann White,10 Azin Parhizgar,6 Thomas Engels,6 Roxana Mehran,11 Stephan Haussig,12 Felix Woitek,12 Norman Mangner,12 Martin Leon,13 Nicolas Van Mieghem14 1 University of Leipzig Heart Center, Leipzig, Germany; 2Heart and Vascular Institute, Cleveland, Ohio, United States; 3New YorkPresbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 4Cedars-Sinai Medical Center, Los Angeles, California, United States; 5Columbia University Medical Center, Chicago, Illinois, United States; 6Claret Medical, Santa Rosa, California, United States; 7Buffalo Neuroimaging Analysis Center University at Buffalo, Buffalo, New York, United States; 8Buffalo Neuroimaging Analysis Center, University at Buffalo, Buffalo, New York, United States; 9NAMSA, Minneapolis, Minnesota, United States; 10DCRI, Durham, North Carolina, United States; 11Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, New York, New York, United States; 12University of Leipzig - Heart Center, Leipzig, Germany; 13 Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, United States; 14Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherland
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 70, NO. 18, SUPPL B, 2017
BACKGROUND Neurological events and brain infarction remain a concern after transcatheter aortic valve replacement (TAVR). While Cerebral Embolic Protection (CEP) devices provide meaningful protection, recent trials still showed substantial variability in individual outcomes. There remains a strong need to identify individual patient outcome predictors. Pre-existing white matter disease (T2-FLAIR positive lesion volume) may reflect overall susceptibility to cerebrovascular insults. In this context, we set out to determine whether preprocedural T2-FLAIR cerebral lesions are predictive of new brain infarction and/or neurological events after TAVR. METHODS Data from the SENTINEL trial was analyzed post hoc. Subjects were split into two groups, based on median baseline T2FLAIR lesion volume, and 30 day MACCE rates, stroke rates, and 27day post-TAVR new ischemic lesion (DWI) volumes were compared between groups. RESULTS A total of 228 subjects were included in the analysis, with a mean age of 83.1 (7.8). MACCE and stroke rates for the above-median T2-lesion volume group were numerically higher than the belowmedian group (10.5% vs. 5.3% for MACCE and 8.8% vs. 4.4% for stroke), but the differences did not reach significance. In contrast, median post-TAVR new ischemic lesion volume was more than twice as large in those with high baseline T2 lesion volume (479.9 mm3 vs. 197.8 mm3), and the difference was highly significant (p<0.001). CONCLUSION Pre-existing T2- FLAIR lesion burden strongly predicts new procedure-related DWI lesion volume in TAVR, and should be included as a covariate when using that endpoint in studies. Its relationship with MACCE and stroke rates is less clear, and needs further study in larger cohorts. CATEGORIES ENDOVASCULAR: Stroke and Stroke Prevention TCT-423 Is there a difference in cerebral infarcts in patients who undergo TAVR for calcified aortic valve stenosis compared to pure aortic regurgitation? Ermela Yzeiraj,1 Timo Haselbach,2 Julian Witt,3 Klaudija Bijuklic,1 Lorenz Hansen,2 Friedrich-Christian Rieß,4 Joachim Schofer5 1 Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg, Germany; 2 Albertinen Krankenhaus, Hamburg, Germany; 3Albertinen Krankenhaus Hamburg, Hamburg, Germany; 4Albertinen Heart Center, Hamburg, Germany, Hamburg, Germany; 5Medical Care Center Prof. Mathey, Prof. Schofer and Albertinen Heart Center, Hamburg, Hamburg, Germany BACKGROUND Transcatheter aortic valve replacement (TAVR) is associated with the risk of symptomatic or silent cerebral infarcts (CIs). The role of aortic valve calcification on CIs is not well known. The purpose of this study was to investigate the impact of aortic valve complex calcification on CIs in patients with a wide range of calcification undergoing TAVR using a retrievable prosthesis and to identify predictors of CIs. METHODS One hundred and nine consecutive patients who underwent transfemoral TAVR using the Direct Flow Medical (DFM, Santa Rosa, California) prosthesis and received a cerebral DW-MRI 3-5 day after TAVR, were included in the study. Volumetric quantification of aortic valve complex calcification was performed from pre-procedural multislice computed tomography. RESULTS Out of 109 patients, 102 (93.6) had severe calcified aortic valve stenosis (AVS) and 7 patients (6.4%) had pure aortic regurgitation (AR). Aortic valve complex calcium in patients with AVS was 290 mm3 and in patients with AR 12 mm3 (p¼0.009). New CIs were found in 78% of patients. The incidence of CIs was comparable between patients with AVS and patients with pure AR (77.5% versus 85.7%, p¼1.000) whereas the number of new CIs per patient was significantly higher in the pure AR group (median 4 (IQR 3-13) versus 2 (IQR 1-5), p¼0.001). The same was true for total lesion volume per patient (280 mm3 (241-2319) in patients with pure AR versus 148 mm3 (18-368) in patients with AVS, p¼0.013). In the multivariate logistic regression analysis no independent predictor for new CIs could be identified. CONCLUSION Patients with calcified AVS undergoing TAVI do not have a higher incidence of CIs compared to patients with pure AR. Surprisingly, patients with pure AR had higher lesion number and volume per patient. Aortic valve calcification was not correlated with CIs. Further studies are needed to better understand the mechanism of CIs and address the use of cerebral protection devices during TAVR procedure. CATEGORIES STRUCTURAL: Valvular Disease: Aortic
TCT-424 Brief Cognitive Behavioral Therapy for Patients Undergoing TAVR: A Randomized Controlled Trial Katharine Edwards,1 Derik Hossepian,2 Audrey Johnson,2 Catherine Dao,3 Sonia Shah,4 William Fearon5 1 Stanford University, Stanford, CA, California, United States; 2Palo Alto University, Palo Alto, California, United States; 3Washington Township Medical Foundation, Fremont, California, United States; 4Stanford University, Stanford, California, United States; 5Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, California, United States BACKGROUND Depression occurs in 15-40% of cardiac surgery patients and has been associated with cardiac morbidity, re-hospitalization, decreased functional status, and lower quality of life (QOL). Cognitive behavioral therapy (CBT) is an effective, evidence-based treatment for depression and anxiety. Preliminary studies have shown transcatheter aortic valve replacement (TAVR) to benefit physical function and QOL, with modest gains in mental health compared to standard therapy. However, to date no published trials have looked at the impact of treating depression or anxiety in these patients. METHODS Of 129 patients consented for mental health screening prior to TAVR, 44 (34%) endorsed clinically significant anxiety or depression at baseline. Patients were randomized to brief bedside CBT delivered during their hospital stay (n¼25) or treatment as usual control (n¼19). Self-report measures for depression (Beck Depression Inventory-II) and QOL (Minnesota Living with Heart Failure Questionnaire) were administered again at discharge and 1-month follow up. RESULTS Despite randomization, baseline depression scores were not equivalent between groups (F¼4.45, p<0.05) and standard ANOVA comparisons were non-significant. However, mean change on the BDIII from baseline to 1-month follow up was clinically significant for the CBT group (D¼-6.78) but not the control group (D¼-4.75) and change scores from baseline to 1-month follow up were greater for the CBT group (D¼-2.85) than the control group (D¼-0.54; t¼-1.54, p¼0.05). Mean change in QOL as measured by the MLHFQ was moderately-tomarkedly improved in the CBT group (D¼19.21) vs. mildly improved in the control group (D¼13.54). CONCLUSION Previous studies have established that brief CBT targeting post-operative depression and anxiety are feasibly and acceptable for patients undergoing CABG surgery. This is the first study to examine a similar intervention for TAVR patients, and data suggest that brief CBT is a promising intervention for improving mood and QOL post discharge. Additional findings will be presented regarding health care utilization and predictors of post-operative depression and anxiety. CATEGORIES STRUCTURAL: Valvular Disease: Aortic TCT-425 Impact of cerebral protection in aortic stenosis patients treated with transcatheter aortic valve replacement on functional and structural integrity of the brain: results of a combined patient-level analysis of three randomized controlled trials Axel Linke,1 Samir Kapadia,2 Susheel Kodali,3 Raj Makkar,4 Maria Alu,5 Peyton Willert,6 Michael Dwyer,7 Robert Zivadinov,8 Lisa Thackeray,9 Roseann White,10 Azin Parhizgar,6 Thomas Engels,6 Roxana Mehran,11 Stephan Haussig,12 Felix Woitek,12 Norman Mangner,12 Martin Leon,13 Nicolas Van Mieghem14 1 University of Leipzig Heart Center, Leipzig, Germany; 2Heart and Vascular Institute, Cleveland, Ohio, United States; 3New YorkPresbyterian Hospital/Columbia University Medical Center, New York, New York, United States; 4Cedars-Sinai Medical Center, Los Angeles, California, United States; 5Columbia University Medical Center, Chicago, Illinois, United States; 6Claret Medical, Santa Rosa, California, United States; 7Buffalo Neuroimaging Analysis Center University at Buffalo, Buffalo, New York, United States; 8Buffalo Neuroimaging Analysis Center, University at Buffalo, Buffalo, New York, United States; 9NAMSA, Minneapolis, Minnesota, United States; 10DCRI, Durham, North Carolina, United States; 11Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai Hospital, New York, New York, United States; 12University of Leipzig - Heart Center, Leipzig, Germany; 13 Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, United States; 14Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherland