119 results on '"Inglessis I"'
Search Results
2. Tuberous sclerosis complex and myocardial fat-containing lesions: a report of four cases
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Winterkorn, E B, Dodd, J D, Inglessis, I, Holmvang, G, and Thiele, E A
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- 2007
3. Homocysteine Level in Pfo Related Stroke Patients with Respect to Medical Therapy vs pfo Closure
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Deng, W, primary, Wickham, T, additional, McMullin, D, additional, Feeney, K, additional, Silverman, S, additional, Inglessis, I, additional, Palacios, I, additional, Lo, EH, additional, Buonanno, FS, additional, and Ning, M, additional
- Published
- 2016
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4. Pfo Closure Reduces Plasma Levels of Serotonin in a long term Followup of Stroke Patients
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Deng, W, primary, McMullin, D, additional, Wickham, T, additional, Feeney, K, additional, Inglessis, I, additional, Palacios, I, additional, Buonanno, FS, additional, Lo, EH, additional, and Ning, M, additional
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- 2016
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5. Effect of Patent Foramen Ovale (PFO) Endovascular Closure on Stroke Quality of Life (P4.229)
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K, Feeney-Heinzelmann, primary, Ning, MingMing, additional, Deng, W, additional, Wickham, T, additional, Inglessis, I, additional, Lo, Eng, additional, Palacios, I, additional, and Buonanno, Ferdinando, additional
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- 2014
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6. The Aortic Valve Calcium Nodule Score (AVCNS) independently predicts paravalvular regurgitation after Transcatheter Aortic Valve Implantation (TAVI)
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Azzalini, L., primary, Ghoshhajra, B., additional, Elmariah, S., additional, Passeri, J. J., additional, Inglessis, I., additional, Palacios, I., additional, and Abbara, S., additional
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- 2013
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7. P029 * Brain natriuretic peptide as a predictor of volume overload in childrenwith congenital cardiac shunt lesion
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Saad, I. A., primary, Li, Y. M., additional, Xie, M. X., additional, Lu, Q., additional, Lu, X. F., additional, He, L., additional, Dong, N. G., additional, Lv, Q., additional, Lu, X., additional, Margey, R., additional, Arzamendi, D., additional, Hynes, B., additional, Elmariah, S., additional, Hatim, M., additional, Moran, D., additional, Ruggiero, N., additional, Kiernan, T., additional, Renfigo-Moreno, P., additional, Schainfeld, R., additional, Jaff, M. R., additional, Inglessis, I., additional, and Palacios, I. P., additional
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- 2012
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8. P058 * APACHE II score, rather than cardiac function, may predict poor prognosis in patients with stress-induced cardiomyopathy
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Joe, B. H., primary, Sohn, I. S., additional, Park, B. J., additional, Park, J. H., additional, Jin, E. S., additional, Cho, J. M., additional, Kim, C. J., additional, Saleh, A., additional, Matsumori, A., additional, Negm, H., additional, Shalaby, M., additional, Haykal, M., additional, Tsverava, M., additional, Tsverava, D., additional, Lobjanidse, N., additional, Han, J. Y., additional, Ha, S. I., additional, Yang, J. S., additional, Choi, D. H., additional, Chung, J. W., additional, Koh, Y. Y., additional, Chang, K. S., additional, Hong, S. P., additional, Adachi, H., additional, Taguchi, T., additional, Oshima, H., additional, Huang, F. Q., additional, Zhong, L., additional, Le, T. t., additional, Tan, R. S., additional, Zhao, Q. Y., additional, Yu, S. B., additional, Huang, H., additional, Qin, M., additional, Cui, H. Y., additional, Huang, T., additional, Huang, C. X., additional, Chan, W. Y. W., additional, Blomqvist, A., additional, Melton, I. C., additional, Crozier, I. G., additional, Noren, K., additional, Troughton, R. W., additional, Indriani, S., additional, Siswanto, B. B., additional, Soerarso, R., additional, Hersunarti, N., additional, Harimurti, G. M., additional, Margey, R., additional, Hynes, B., additional, Pomerantsev, E., additional, Moran, D., additional, Hatim, M., additional, Kiernan, T., additional, Inglessis, I., additional, Palacios, I., additional, Suh, W., additional, Witzke, C., additional, Yeh, R., additional, Sahkuja, R., additional, Seto, A., additional, Chen, Y., additional, Li, H., additional, Zhou, B., additional, Shi, S. Q., additional, Rao, L., additional, Gong, H., additional, Wang, X., additional, Ling, Y., additional, Obispo-Mortos, S. A., additional, Reyes, D. R. C., additional, Cabasan, G., additional, Caguioa, E. V. S., additional, Ramirez, M. F. L., additional, Navarra, S. V., additional, Wang, S., additional, Lam, Y. Y., additional, Fang, F., additional, Shang, Q., additional, Luo, X. X., additional, Liu, M., additional, Wang, J., additional, Sanderson, J. E., additional, Sun, J. P., additional, Yu, C. M., additional, Hernandez-Madrid, A., additional, Matia Frances, R., additional, Bullon, M., additional, Moro, C., additional, Kwong, S. W., additional, Lee, P. W., additional, Larina, V. N., additional, and Bart, B. Y., additional
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- 2012
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9. Ventricular tachycardia following trans-apical aortic valve replacement
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Beinart, R., primary, Danik, S., additional, Palacios, I., additional, Barrett, C., additional, Inglessis, I., additional, Agnihotri, A., additional, and Passeri, J., additional
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- 2011
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10. Hemodynamic effects of inhaled nitric oxide in right ventricular myocardial infarction and cardiogenic shock
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Inglessis, I., primary, Shin, J.T., additional, and Leporeet, J.J., additional
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- 2004
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11. Immediate and long term outcome of percutaneous mitral balloon valvotomy in patients with mitral stenosis and atrial fibrillation
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Leon, M.N., primary, Harrell, L., additional, Mahdi, N.A., additional, Simosa, H., additional, Inglessis, I., additional, Pathan, A., additional, Lopez, J., additional, Mikulic, M., additional, Moreno, P.R., additional, and Palacios, I.F., additional
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- 1998
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12. Interventional catheterization in adult congenital heart disease.
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Inglessis I and Landzberg MJ
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- 2007
13. Ventricular tachycardia following trans-apical aortic valve replacement.
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Beinart R, Danik S, Palacios I, Barrett C, Inglessis I, Agnihotri A, and Passeri J
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- 2012
14. May-Thurner syndrome in patients with cryptogenic stroke and patent foramen ovale: an important clinical association.
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Kiernan TJ, Yan BP, Cubeddu RJ, Rengifo-Moreno P, Gupta V, Inglessis I, Ning M, Demirjian ZN, Jaff MR, Buonanno FS, Schainfeld RM, Palacios IF, Kiernan, Thomas J, Yan, Bryan P, Cubeddu, Roberto J, Rengifo-Moreno, Pablo, Gupta, Vishal, Inglessis, Ignacio, Ning, MingMing, and Demirjian, Zareh N
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- 2009
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15. Spontaneous spiral dissection of a LIMA-LAD bypass graft: a case report.
- Author
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Wong P, Rubenstein M, Inglessis I, Pomerantsev E, Ferrell M, and Leinbach R
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We describe an unusual case of spontaneous spiral dissection of a LIMA-LAD bypass graft presenting with an acute coronary syndrome. This complex lesion was treated percutaneously with multiple coronary stents. [ABSTRACT FROM AUTHOR]
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- 2004
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16. Cardiac involvement is a constant finding in acute Chagas' disease: a clinical, parasitological and histopathological study
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Parada, H., Carrasco, H. A., ez, N. A, Fuenmayor, C., and Inglessis, I.
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- 1997
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17. Comparison of procedural and in-hospital outcomes of percutaneous balloon aortic valvuloplasty in patients >80 years versus patients < or =80 years.
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Don CW, Witzke C, Cubeddu RJ, Herrero-Garibi J, Pomerantsev E, Caldera AE, McCarty D, Inglessis I, Palacios IF, Don, Creighton W, Witzke, Christian, Cubeddu, Roberto J, Herrero-Garibi, Jesus, Pomerantsev, Eugene, Caldera, Angel E, McCarty, David, Inglessis, Ignacio, and Palacios, Igor F
- Abstract
Percutaneous balloon aortic valvuloplasty (PBAV) is a procedure used for palliation, bridging to surgery, and as an integral step in the procedure for percutaneous aortic valve replacement. Older patients with severe aortic stenosis are thought to have greater risk for adverse perioperative events than younger patients. The aim of this study was to evaluate the outcomes of patients aged >80 years and those aged < or =80 years who underwent PBAV to identify factors associated with adverse clinical outcomes. This was a retrospective study of 111 consecutive patients with severe symptomatic aortic stenosis who underwent retrograde PBAV at Massachusetts General Hospital from December 2004 to December 2008. Forty-nine patients (44%) were men, and the mean age for the whole group was 82 +/- 8 years. Patients were divided into 2 age groups: those aged >80 years (n = 73) and those aged < or =80 years (n = 38). Procedural outcomes, complications, and in-hospital adverse events were compared. Multivariate logistic regression was used for the adjusted analysis. Nearly 90% of patients were in New York Heart Association class III or IV. Patients aged >80 years had lower baseline ejection fractions (43.5% vs 56.1%, p <0.01) and smaller aortic valve areas (0.59 vs 0.73 cm(2), p <0.01). Although the 2 age groups had a similar percentage of aortic valve area increase (55.5% vs 45.2%, p = 0.28), those aged >80 years had smaller post-PBAV aortic valve areas (0.89 vs 1.02 cm(2), p <0.05). Overall, in-hospital mortality was 8.1%, with no significant differences between the groups. Advanced age was not an independent predictor of in-hospital death, myocardial infarction, stroke, cardiac arrest, or tamponade; however, patients aged >80 years had a significantly higher incidence of intraprocedural emergent intubation and cardiopulmonary resuscitation compared to the younger group. New York Heart Association class was the only independent predictor of worse in-hospital outcomes. In conclusion, compared to younger patients, those aged >80 years had less favorable preprocedural characteristics for PBAV but similar overall in-hospital clinical outcomes. Patients aged >80 years had significantly higher incidence of emergent intubation and cardiopulmonary resuscitation during PBAV. [ABSTRACT FROM AUTHOR]
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- 2010
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18. Comparison of sixty-four-slice multidetector computed tomographic coronary angiography to coronary angiography with intravascular ultrasound for the detection of transplant vasculopathy.
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Gregory SA, Ferencik M, Achenbach S, Yeh RW, Hoffmann U, Inglessis I, Cury RC, Nieman K, McNulty IA, Laffan JA, Pomerantsev EV, Brady TJ, Semigran MJ, and Jang IK
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- 2006
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19. 277: Image quality of 64-slice Multi-Detector Computed Tomography Coronary Angiography in heart transplant recipients
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Ferencik, M., Gregory, S.A., Achenbach, S., Yeh, R.W., Hoffmann, U., Inglessis, I., Cury, R.C., Nieman, K., Raffel, O.C., McNulty, I.A., Brady, T.J., Semigran, M.J., and Jang, I.K.
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- 2006
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20. PFO Closure in Patients Older Than 60 Years: Reconsidering FDA Age-Based Approval Policies.
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Ben-Assa E, Kolte D, Sakhuja R, Hung J, Cruz-Gonzalez I, Laish-Farkash A, Haratz S, Rengifo-Moreno P, Ning M, Inglessis I, and Palacios IF
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- 2024
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21. Outcomes of Transcatheter Aortic Valve Replacement Using Third-Generation Balloon-Expandable Versus Self-Expanding Valves: A Meta-analysis.
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Siddiqui SA, Kazemian S, Gupta T, Patel NK, Sakhuja R, Inglessis I, Jassar A, Langer N, Passeri JJ, Dauerman HL, Elmariah S, and Kolte D
- Abstract
Background: The choice of transcatheter aortic valve replacement (TAVR) prosthesis is crucial in optimizing short- and long-term outcomes. The objective of this study was to conduct a meta-analysis comparing outcomes of third-generation balloon-expandable valves (BEV) vs self-expanding valves (SEV)., Methods: Electronic databases were searched from inception to June 2023 for studies comparing third-generation BEV vs SEV. Primary outcome was all-cause mortality. Secondary outcomes included clinical and hemodynamic end points. Random-effects models were used to calculate pooled odds ratios (ORs) or weighted mean differences (WMDs)., Results: The meta-analysis included 16 studies and 10,174 patients (BEV, 5753 and SEV, 4421). There were no significant differences in 1-year all-cause mortality (OR, 1.15; 95% CI, 0.89-1.48) between third-generation BEV vs SEV. TAVR with third generation BEV was associated with a significantly lower risk of TIA/stroke (OR, 0.62; 95% CI, 0.44-0.87), permanent pacemaker implantation (OR, 0.55; 95% CI, 0.44-0.70), and ≥moderate paravalvular leak (PVL, OR, 0.43; 95% CI, 0.25-0.75), and higher risk of ≥moderate patient-prosthesis mismatch (OR, 3.76; 95% CI, 2.33-6.05), higher mean gradient (WMD, 4.35; 95% CI, 3.63-5.08), and smaller effective orifice area (WMD, -0.30; 95% CI, -0.37 to -0.23), compared with SEV., Conclusion: In this meta-analysis, TAVR with third-generation BEV vs SEV was associated with similar all-cause mortality, lower risk of TIA/stroke, permanent pacemaker implantation, and ≥moderate PVL, but higher risk of ≥moderate patient-prosthesis mismatch, higher mean gradient, and smaller effective orifice area. Large, adequately powered randomized trials are needed to evaluate long-term outcomes of TAVR with latest generations of BEV vs SEV., (© 2024 The Author(s).)
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- 2024
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22. Case 32-2023: A 62-Year-Old Woman with Recurrent Hemorrhagic Pericardial Effusion.
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Yucel E, Patel NK, Crousillat DR, Baliyan V, Jassar AS, Palacios I, Inglessis I, and Smith RN
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- Female, Humans, Middle Aged, Recurrence, Cardiac Tamponade, Pericardial Effusion diagnostic imaging, Pericardial Effusion etiology, Hemorrhage complications, Hemorrhage diagnostic imaging
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- 2023
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23. Impact of Moderate Aortic Stenosis in Patients With Heart Failure With Reduced Ejection Fraction.
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Khan KR, Khan OA, Chen C, Liu Y, Kandanelly RR, Jamiel PJ, Tanguturi V, Hung J, Inglessis I, Passeri JJ, Langer NB, and Elmariah S
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- Humans, Stroke Volume, Ventricular Function, Left, Retrospective Studies, Heart Failure complications, Heart Failure epidemiology, Ventricular Dysfunction, Left, Aortic Valve Stenosis complications, Aortic Valve Stenosis surgery
- Abstract
Background: Afterload from moderate aortic stenosis (AS) may contribute to adverse outcomes in patients with heart failure with reduced ejection fraction (HFrEF)., Objectives: The authors evaluated clinical outcomes in patients with HFrEF and moderate AS relative to those without AS and with severe AS., Methods: Patients with HFrEF, defined by left ventricular ejection fraction (LVEF) <50% and no, moderate, or severe AS were retrospectively identified. The primary endpoint, defined as a composite of all-cause mortality and heart failure (HF) hospitalization, was compared across groups and within a propensity score-matched cohort., Results: We included 9,133 patients with HFrEF, of whom 374 and 362 had moderate and severe AS, respectively. Over a median follow-up time of 3.1 years, the primary outcome occurred in 62.7% of patients with moderate AS vs 45.9% with no AS (P < 0.0001); rates were similar with severe and moderate AS (62.0% vs 62.7%; P = 0.68). Patients with severe AS had a lower incidence of HF hospitalization (36.2% vs 43.6%; P < 0.05) and were more likely to undergo AVR within the follow-up period. Within a propensity score-matched cohort, moderate AS was associated with an increased risk of HF hospitalization and mortality (HR: 1.24; 95% CI: 1.04-1.49; P = 0.01) and fewer days alive outside of the hospital (P < 0.0001). Aortic valve replacement (AVR) was associated with improved survival (HR: 0.60; CI: 0.36-0.99; P < 0.05)., Conclusions: In patients with HFrEF, moderate AS is associated with increased rates of HF hospitalization and mortality. Further investigation is warranted to determine whether AVR in this population improves clinical outcomes., Competing Interests: Funding Support and Author Disclosures Dr Tanguturi has received a research grant from Edwards Lifesciences. Dr Elmariah has received research grants from the American Heart Association (19TPA34910170), National Institutes of Health (R01 HL151838), Edwards Lifesciences, Svelte Medical, Abbott Vascular, and Medtronic; and has received consulting fees from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
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24. Severity of and Recovery From Anemia After Transcatheter Aortic Valve Replacement: An Analysis of the PARTNER Trials and Registries.
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Bhardwaj B, Kolte D, Zhao Y, Alu MC, Zahr F, Passeri JJ, Inglessis I, Vlahakes GJ, Garcia S, Cohen DJ, Makkar RR, Kodali S, Thourani VH, Kapadia S, Palacios IF, Leon MB, Smith CR, Mack MJ, and Elmariah S
- Abstract
Background: Anemia is associated with increased mortality in patients undergoing transcatheter aortic valve replacement (TAVR); however, data on the effect of the severity of and recovery from anemia on clinical outcomes are limited. This study examined the impact of the severity of and recovery from anemia after TAVR., Methods: Patients with symptomatic, severe aortic stenosis across all surgical risk groups from the Placement of Aortic Transcatheter Valves (PARTNER) I, II, and III trials and registries who underwent TAVR were analyzed. Baseline anemia was defined as mild (hemoglobin [Hb] level ≥11.0 g/dL and <13.0 g/dL for men and ≥11.0 g/dL and <12.0 g/dL for women) and moderate-to-severe anemia (Hb level <11.0 g/dL). Recovery from anemia was defined as an increase of ≥1 g/dL in the Hb level. Patients with missing Hb information and major bleeding within 30 days were excluded. The association of the severity of and recovery from anemia with clinical outcomes was analyzed using multivariable Cox proportional hazards regression models. The primary outcome was 1-year all-cause mortality., Results: The Kaplan-Meier estimate for 1-year all-cause mortality was 5.4%, 8.2%, and 14.5% in patients with no, mild, and moderate-to-severe anemia, respectively ( P < .001). Recovery from anemia at 30 days occurred in 8.4% (229/2730) of all patients. Compared with those without baseline or 30-day anemia, patients with recovery from anemia had similar 1-year mortality (hazard ratio, 1.02; CI, 0.50-2.08; P = .96), whereas those without recovery from anemia had higher 1-year mortality (hazard ratio, 1.82; CI, 1.17-2.85; P = .009)., Conclusions: In patients undergoing TAVR, moderate-to-severe anemia is independently associated with increased 1-year mortality, and recovery from anemia after TAVR is associated with favorable outcomes. Further efforts are needed to determine whether preprocedural correction of anemia improves post-TAVR outcomes., (© 2022 The Authors.)
- Published
- 2022
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25. Incidence and Predictors of New-Onset Atrial Fibrillation After Transcatheter Edge-to-Edge Repair of the Mitral Valve (from the Nationwide Readmissions Database).
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Lima FV, Berkowitz J, Kennedy KF, Kolte D, Saad M, Elmariah S, Palacios IF, Inglessis I, Khera S, Assa EB, Gordon P, and Chu AF
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- Electrolytes, Humans, Incidence, Mitral Valve surgery, Patient Readmission, Postoperative Complications etiology, Risk Factors, Aortic Valve Stenosis surgery, Atrial Fibrillation etiology, Heart Failure complications, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Patients who underwent transcatheter edge-to-edge repair (TEER) for mitral regurgitation with atrial fibrillation (AF) at baseline have higher mortality than those without AF. Data on new-onset AF (NOAF) after TEER are limited. Using the 2016 to 2018 Nationwide Readmissions Database, we identified a cohort of patients who underwent TEER and classified them into 3 groups based on AF presence during the study period. The primary end point was the incidence and timing of NOAF up to 6 months after TEER. Logistic regression modeling identified independent predictors of NOAF at readmission. Of the 6,861patients that underwent TEER, 4,134 (59.9%) had AF at baseline, and 239 (3.5%) developed NOAF. Median time-to-NOAF admission was 47 days (interquartile range 16 to 113), and 37% of patients with NOAF presented within 30 days after TEER. Patients with NOAF experienced costlier and longer index-TEER hospitalization and had more co-morbidities. Chronic kidney disease (odds ratio [OR] 1.51, 95% confidence interval [CI] 1.03 to 2.20), fluid and electrolyte disorders (OR 1.59, 95% CI 1.01 to 2.52), and heart failure (OR 1.86, 95% CI 1.01 to 3.44) were identified as independent predictors of NOAF. Hypertensive complications and heart failure were the leading causes of readmission. In conclusion, those patients that developed NOAF after TEER tended to be an overall sicker group at baseline compared with the remainder of the study cohort. These data, obtained from a nationally representative cohort, highlight a particular group of patients subject to developing NOAF and their association with increased rehospitalization in the post-TEER setting. Predictors of NOAF can be screened for during TEER workup to identify patients at increased risk., Competing Interests: Disclosures Dr. Khera is a consultant, speaker, and proctor for Medtronic; a consultant for Terumo, Abbott, and Boston Scientific; and a speaker for Zoll Medical. Dr. Elmariah received research grants from Edwards Lifesciences, Medtronic, and Abbott Vascular and is also a consultant for Edwards Lifesciences. The remaining authors have no conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)
- Published
- 2022
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26. Association Between Early Left Ventricular Ejection Fraction Improvement After Transcatheter Aortic Valve Replacement and 5-Year Clinical Outcomes.
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Kolte D, Bhardwaj B, Lu M, Alu MC, Passeri JJ, Inglessis I, Vlahakes GJ, Garcia S, Cohen DJ, Lindman BR, Kodali S, Thourani VH, Daubert MA, Douglas PS, Jaber W, Pibarot P, Clavel MA, Palacios IF, Leon MB, Smith CR, Mack MJ, and Elmariah S
- Subjects
- Aged, 80 and over, Cohort Studies, Death, Female, Humans, Male, Stroke Volume, Ventricular Function, Left, Aortic Valve Stenosis, Myocardial Infarction surgery, Transcatheter Aortic Valve Replacement
- Abstract
Importance: In patients with severe aortic stenosis and left ventricular ejection fraction (LVEF) less than 50%, early LVEF improvement after transcatheter aortic valve replacement (TAVR) is associated with improved 1-year mortality; however, its association with long-term clinical outcomes is not known., Objective: To examine the association between early LVEF improvement after TAVR and 5-year outcomes., Design, Setting, and Participants: This cohort study analyzed patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 1, 2, and S3 trials and registries between July 2007 and April 2015. High- and intermediate-risk patients with baseline LVEF less than 50% who underwent transfemoral TAVR were included in the current study. Data were analyzed from August 2020 to May 2021., Exposures: Early LVEF improvement, defined as increase of 10 percentage points or more at 30 days and also as a continuous variable (ΔLVEF between baseline and 30 days)., Main Outcomes and Measures: All-cause death at 5 years., Results: Among 659 included patients with LVEF less than 50%, 468 (71.0%) were male, and the mean (SD) age was 82.4 (7.7) years. LVEF improvement within 30 days following transfemoral TAVR occurred in 216 patients (32.8%) (mean [SD] ΔLVEF, 16.4 [5.7%]). Prior myocardial infarction, diabetes, cancer, higher baseline LVEF, larger left ventricular end-diastolic diameter, and larger aortic valve area were independently associated with lower likelihood of LVEF improvement. Patients with vs without early LVEF improvement after TAVR had lower 5-year all-cause death (102 [50.0%; 95% CI, 43.3-57.1] vs 246 [58.4%; 95% CI, 53.6-63.2]; P = .04) and cardiac death (52 [29.5%; 95% CI, 23.2-37.1] vs 135 [38.1%; 95% CI, 33.1-43.6]; P = .05). In multivariable analyses, early improvement in LVEF (modeled as a continuous variable) was associated with lower 5-year all-cause death (adjusted hazard ratio per 5% increase in LVEF, 0.94 [95% CI, 0.88-1.00]; P = .04) and cardiac death (adjusted hazard ratio per 5% increase in LVEF, 0.90 [95% CI, 0.82-0.98]; P = .02) after TAVR. Restricted cubic spline analysis demonstrated a visual inflection point at ΔLVEF of 10% beyond which there was a steep decline in all-cause mortality with increasing degree of LVEF improvement. There were no statistically significant differences in rehospitalization, New York Heart Association functional class, or Kansas City Cardiomyopathy Questionnaire Overall Summary score at 5 years in patients with vs without early LVEF improvement. In subgroup analysis, the association between early LVEF improvement and 5-year all-cause death was consistent regardless of the presence or absence of coronary artery disease or prior myocardial infarction., Conclusions and Relevance: In patients with severe aortic stenosis and LVEF less than 50%, 1 in 3 experience LVEF improvement within 1 month after TAVR. Early LVEF improvement is associated with lower 5-year all-cause and cardiac death.
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- 2022
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27. Transcatheter Treatment of Ascending Aortic Pathology: Are we there Yet?
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Jassar AS and Inglessis I
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- Aorta surgery, Humans, Treatment Outcome, Transcatheter Aortic Valve Replacement
- Abstract
Competing Interests: The authors report no conflicts of interests.
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- 2022
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28. Patient- and Process-Related Contributors to the Underuse of Aortic Valve Replacement and Subsequent Mortality in Ambulatory Patients With Severe Aortic Stenosis.
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Flannery L, Etiwy M, Camacho A, Liu R, Patel N, Tavil-Shatelyan A, Tanguturi VK, Dal-Bianco JP, Yucel E, Sakhuja R, Jassar AS, Langer NB, Inglessis I, Passeri JJ, Hung J, and Elmariah S
- Subjects
- Aortic Valve diagnostic imaging, Aortic Valve surgery, Female, Humans, Male, Propensity Score, Severity of Illness Index, Stroke Volume, Treatment Outcome, Ventricular Function, Left, Aortic Valve Stenosis complications, Aortic Valve Stenosis surgery, Heart Valve Prosthesis Implantation
- Abstract
Background Many patients with severe aortic stenosis (AS) and an indication for aortic valve replacement (AVR) do not undergo treatment. The reasons for this have not been well studied in the transcatheter AVR era. We sought to determine how patient- and process-specific factors affected AVR use in patients with severe AS. Methods and Results We identified ambulatory patients from 2016 to 2018 demonstrating severe AS, defined by aortic valve area [Formula: see text]1.0 cm
2 . Propensity scoring analysis with inverse probability of treatment weighting was used to evaluate associations between predictors and the odds of undergoing AVR at 365 days and subsequent mortality at 730 days. Of 324 patients with an indication for AVR (79.3±9.7 years, 57.4% men), 140 patients (43.2%) did not undergo AVR. The odds of AVR were reduced in patients aged >90 years (odds ratio [OR], 0.24 [95% CI, 0.08-0.69]; P =0.01), greater comorbid conditions (OR, 0.88 per 1-point increase in Combined Comorbidity Index [95% CI, 0.79-0.97]; P =0.01), low-flow, low-gradient AS with preserved left ventricular ejection fraction (OR, 0.11 [95% CI, 0.06-0.21]), and low-gradient AS with reduced left ventricular ejection fraction (OR, 0.18 [95% CI, 0.08-0.40]) and were increased if the transthoracic echocardiogram ordering provider was a cardiologist (OR, 2.46 [95% CI, 1.38-4.38]). Patients who underwent AVR gained an average of 85.8 days of life (95% CI, 40.9-130.6) at 730 days. Conclusions The proportion of ambulatory patients with severe AS and an indication for AVR who do not receive AVR remains significant. Efforts are needed to maximize the recognition of severe AS, especially low-gradient subtypes, and to encourage patient referral to multidisciplinary heart valve teams.- Published
- 2022
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29. Impact of Decision Aid on Decision-making of Patients With Severe Aortic Stenosis: Randomized Pilot Study.
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Valentine KD, Marques F, Selberg A, Flannery L, Langer N, Inglessis I, Passeri J, Sundt T, Sepucha K, and Elmariah S
- Abstract
Background: Clinical guidelines recommend patients with aortic stenosis (AS) being considered for transcatheter aortic valve implantation or surgical aortic valve replacement to participate in shared decision-making (SDM) with a heart valve team (HVT). Data supporting these recommendations are limited. This project gathered data on feasibility and preliminary efficacy of a decision aid (DA) in decision-making for patients with severe AS deciding between transcatheter aortic valve implantation and surgical aortic valve replacement., Methods: This institutional review board-approved randomized pilot trial assigned eligible patients to receive either the American College of Cardiology's DA for patients with AS or usual care. Patients were surveyed after their visit regarding knowledge, treatment-preference concordance, SDM (SDM process and CollaboRATE Scales), and decisional conflict. Patients were followed for 3 months to collect data on treatment received., Results: Of 62 patients approached, 59 (95%) consented and participated. The average age of participants was 72 years, they were 100% white, and 32% of them were female. Intervention patients had higher knowledge scores (75.6 vs 65.5) and more frequently reported CollaboRATE top scores (67% vs 33%) than usual care patients. No other group comparisons reached significance. Patients who saw both members of the HVT before survey completion reported higher SDM process scores than those who saw only 1 specialist (3.1 vs 2.4)., Conclusions: The study exceeded enrollment targets, indicating feasibility. Results suggest the American College of Cardiology's DA improved patient knowledge and communication scores. Patients who met with both members of the HVT reported higher SDM. These observations highlight the importance of SDM and multidisciplinary HVT assessment in the management of severe AS., (© 2022 The Authors.)
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- 2022
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30. Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results.
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Kodali S, Hahn RT, George I, Davidson CJ, Narang A, Zahr F, Chadderdon S, Smith R, Grayburn PA, O'Neill WW, Wang DD, Herrmann H, Silvestry F, Elmariah S, Inglessis I, Passeri J, Lim DS, Salerno M, Makar M, Mack MJ, Leon MB, and Makkar R
- Subjects
- Aged, Cardiac Catheterization adverse effects, Female, Humans, Male, Prospective Studies, Quality of Life, Severity of Illness Index, Time Factors, Treatment Outcome, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Heart Valve Prosthesis Implantation, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency etiology, Tricuspid Valve Insufficiency surgery
- Abstract
Objectives: The TRISCEND study (Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy after Replacement of Tricuspid Valve with Transcatheter Device) is evaluating the safety and performance of transfemoral transcatheter tricuspid valve replacement in patients with clinically significant tricuspid regurgitation (TR) and elevated surgical risk., Background: Transcatheter valve replacement could lead to a paradigm shift in treating TR and improving patient quality of life., Methods: In the prospective, single-arm, multicenter TRISCEND study, patients with symptomatic moderate or greater TR, despite medical therapy, underwent percutaneous transcatheter tricuspid valve replacement with the EVOQUE system. A composite rate of major adverse events, echocardiographic parameters, and clinical, functional, and quality-of-life measures were assessed at 30 days., Results: Fifty-six patients (mean age of 79.3 years, 76.8% female, 91.1% TR severe or greater, 91.1% atrial fibrillation, and 87.5% New York Heart Association functional class III or IV) were treated. At 30 days, TR was reduced to mild or less in 98%. The composite major adverse events rate was 26.8% at 30 days caused by 1 cardiovascular death in a patient with a failed procedure, 2 reinterventions after device embolization, 1 major access site or vascular complication, and 15 severe bleeds, of which none were life-threatening or fatal. No myocardial infarction, stroke, renal failure, major cardiac structural complications, or device-related pulmonary embolism were observed. New York Heart Association significantly improved to functional class I or II (78.8%; P < 0.001), 6-minute walk distance improved 49.8 m (P < 0.001), and Kansas City Cardiomyopathy Questionnaire score improved 19 points (P < 0.001)., Conclusions: Early experience with the transfemoral EVOQUE system in patients with clinically significant TR demonstrated technical feasibility, acceptable safety, TR reduction, and symptomatic improvement at 30 days. The TRISCEND II randomized trial (NCT04482062) is underway., Competing Interests: Funding Support and Author Disclosures This work was funded by Edwards Lifesciences. Dr Kodali has received research support from Edwards Lifesciences, Medtronic, Boston Scientific, JenaValve, and Abbott Vascular; has received honoraria from Admedus, TriFlo, and Dura Biotech; and has served on the advisory board and received equity from MicroInterventional Devices, Dura Biotech, Supira, Adona Medical, Thubrikar Aortic Valve, Inc, and TriFlo. Dr Hahn has received speaker fees from Abbott Structural, Edwards Lifesciences, and Philips Healthcare; has received institutional educational and consulting contracts for which she receives no direct compensation from Abbott Structural, Boston Scientific, Edwards Lifesciences, and Medtronic; owns equity in Navigate; and is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr George has served as a consultant for CardioMech, Vdyne, Durvena, MITRx, Neptune Medical, Johnson and Johnson, Atricure, and Mitre Medical. Dr Wang has served a consultant for Edwards Lifesciences, Abbott, Boston Scientific, and Neochord; and has received research grant support from Boston Scientific assigned to her employer, the Henry Ford Health System. Dr Elmariah has received institutional research support from Edwards Lifesciences, Medtronic, and Abbott; and has received consulting fees from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)
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- 2022
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31. Trends in Utilization of Aortic Valve Replacement for Severe Aortic Stenosis.
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Li SX, Patel NK, Flannery LD, Selberg A, Kandanelly RR, Morrison FJ, Kim J, Tanguturi VK, Crousillat DR, Shaqdan AW, Inglessis I, Shah PB, Passeri JJ, Kaneko T, Jassar AS, Langer NB, Turchin A, and Elmariah S
- Subjects
- Aortic Valve diagnostic imaging, Aortic Valve surgery, Humans, Severity of Illness Index, Stroke Volume, Treatment Outcome, Ventricular Function, Left, Aortic Valve Stenosis, Heart Valve Prosthesis Implantation, Transcatheter Aortic Valve Replacement
- Abstract
Background: Despite the rapid growth of aortic valve replacement (AVR) for aortic stenosis (AS), limited data suggest symptomatic severe AS remains undertreated., Objectives: This study sought to investigate temporal trends in AVR utilization among patients with a clinical indication for AVR., Methods: Patients with severe AS (aortic valve area <1 cm
2 ) on transthoracic echocardiograms from 2000 to 2017 at 2 large academic medical centers were classified based on clinical guideline indications for AVR and divided into 4 AS subgroups: high gradient with normal left ventricular ejection fraction (LVEF) (HG-NEF), high gradient with low LVEF (HG-LEF), low gradient with normal LVEF (LG-NEF), and low gradient with low LVEF (LG-LEF). Utilization of AVR was examined and predictors identified., Results: Of 10,795 patients, 6,150 (57%) had an indication or potential indication for AVR, of whom 2,977 (48%) received AVR. The frequency of AVR varied by AS subtype with LG groups less likely to receive an AVR (HG-NEF: 70%, HG-LEF: 53%, LG-NEF: 32%, LG-LEF: 38%, P < 0.001). AVR volumes grew over the 18-year study period but were paralleled by comparable growth in the number of patients with an indication for AVR. In patients with a Class I indication, younger age, coronary artery disease, smoking history, higher hematocrit, outpatient index transthoracic echocardiogram, and LVEF ≥0.5 were independently associated with an increased likelihood of receiving an AVR. AVR was associated with improved survival in each AS-subgroup., Conclusions: Over an 18-year period, the proportion of patients with an indication for AVR who did not receive AVR has remained substantial despite the rapid growth of AVR volumes., Competing Interests: Funding Support and Author Disclosures This study was funded by Edwards Lifesciences. Dr Inglessishas has received institutional research support from Medtronic, St. Jude Medical, and W.L. Gore and Associates; and is a proctor for Medtronic and Edwards Lifesciences. Dr Shah has received educational grants from Edwards Lifesciences, Medtronic, and Abbott Vascular; has received consulting fees from Edwards Lifesciences; has been a proctor for Edwards Lifesciences; and has been an advisory board member for Xenter. Dr Passeri has received institutional research support from Edwards Lifesciences; has been a speaker at an educational symposium sponsored by Medtronic; and has received consulting fees from Medtronic. Dr Kaneko has received consulting fees from Edwards Lifesciences, Medtronic, 4C Medical, CardioMech, Cook Medical; and has been a speaker for Abbott and Baylis. Dr Elmariah has received research grants from American Heart Association (19TPA34910170), National Institutes of Health (R01 HL151838), Edwards Lifesciences, Svelte Medical, Abbott Vascular, and Medtronic; and has received consulting fees from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2022
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32. Association Between Hospital Cardiovascular Procedural Volumes and Transcatheter Mitral Valve Repair Outcomes.
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Kolte D, Butala NM, Kennedy KF, Wasfy JH, Jena AB, Sakhuja R, Langer N, Melnitchouk S, Sundt TM 3rd, Passeri JJ, Palacios IF, Inglessis I, and Elmariah S
- Subjects
- Cardiac Catheterization adverse effects, Hospitals, Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Retrospective Studies, Treatment Outcome, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery, Percutaneous Coronary Intervention adverse effects
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Background: Cardiovascular procedural volumes can serve as metrics of hospital infrastructure and quality, and are the basis for thresholds for initiating transcatheter mitral valve repair (TMVr) programs. Whether hospital volumes of TMVr, surgical mitral valve replacement or repair (SMVRr), and percutaneous coronary intervention (PCI) are indicators of TMVr quality of care is not known., Methods: We used the 2017 Nationwide Readmissions Database to identify hospitals that performed at least 5 TMVr procedures. Hospitals were divided into quartiles of TMVr volume. Associations of hospital TMVr, SMVRr, and PCI volumes, as well as SMVRr and PCI outcomes with TMVr outcomes were examined. Outcomes studied were risk-standardized in-hospital mortality rate (RSMR) and 30-day readmission rate (RSRR)., Results: The study included 3404 TMVr procedures performed across 150 hospitals in the US. The median hospital TMVr volume was 17 (IQR 10, 28). The mean hospital-level RSMR and RSRR for TMVr were 3.0% (95% CI 2.5%, 3.4%) and 14.8% (95% CI 14.5%, 15.0%), respectively. There was no significant association between hospital TMVr volume (as quartiles or as a continuous variable) and TMVr RSMR or RSRR (P > 0.05). Similarly, there was weak or no correlation between hospital SMVRr and PCI volumes and outcomes with TMVr RSMR or RSRR (Pearson correlation coefficients, r = -0.199 to 0.269)., Conclusion: In this study, we found no relationship between hospital TMVr, SMVRr, and PCI volume and TMVr outcomes. Further studies are needed to determine more appropriate structure and process measures to assess the performance of established and new TMVr centers., Competing Interests: Declaration of competing interest Dr. Butala reports consulting fees and ownership interest from HiLabs outside of the submitted work. Dr. Wasfy serves on a NHLBI working group on valvular heart disease and is supported by a grant from the American Heart Association (18 CDA 34110215). Dr. Sakhuja has been a consultant for Medtronic and Edwards Lifesciences. Dr. Passeri has received institutional research support from Edwards Lifesciences; has been a speaker at an educational symposium sponsored by Medtronic; and has received consulting fees from Medtronic. Dr. Palacios is a consultant for Abiomed. Dr. Inglessis has received institutional research support from Medtronic, St. Jude Medical, and W.L. Gore and Associates; and is a proctor for Medtronic and Edwards Lifesciences. Dr. Elmariah is supported by research grants from American Heart Association (19TPA34910170), National Institutes of Health (R01 HL151838), and has received research grants from Edwards Lifesciences and Svelte Medical; and has received consulting fees from Medtronic and AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021. Published by Elsevier Inc.)
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- 2022
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33. Relation of Subacute Kidney Injury to Mortality After Transcatheter Aortic Valve Implantation.
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Cigarroa R, Shaqdan AW, Patel V, Selberg AM, Kandanelly RR, Erickson P, Furman D, Sodhi N, Vatterott A, Palacios IF, Passeri JJ, Vlahakes GJ, Sakhuja R, Inglessis I, Rhee EP, Lindman BR, and Elmariah S
- Subjects
- Aged, Aged, 80 and over, Cohort Studies, Female, Glomerular Filtration Rate, Humans, Male, Multivariate Analysis, Retrospective Studies, Time Factors, Acute Kidney Injury epidemiology, Aortic Valve Stenosis surgery, Mortality, Postoperative Complications epidemiology, Transcatheter Aortic Valve Replacement
- Abstract
Acute kidney injury after transcatheter aortic valve implantation (TAVI) has been associated with adverse outcomes; however, data are limited on the subacute changes in renal function that occur after discharge and their impact on clinical outcomes. This study investigates the relation between subacute changes in kidney function at 30 days after TAVI and survival. Patients from 2 centers who underwent TAVI and survived beyond 30 days with baseline, in-hospital, and 30-day measures of renal function were retrospectively analyzed. Patients were stratified based on change in estimated glomerular filtration rate (eGFR) from baseline to 30 days as follows: improved (≥15% higher than baseline), worsened (≤15% lower), or unchanged (values in between). Univariable and multivariable models were constructed to identify predictors of subacute changes in renal function and of 2-year mortality. Of the 492 patients who met inclusion criteria, eGFR worsened in 102 (22%), improved in 110 (22%), and was unchanged in 280 (56%). AKI occurred in 90 patients (18%) and in only 27% of patients with worsened eGFR at 30 days. After statistical adjustment, worsened eGFR at 30 days (hazard ratio vs unchanged eGFR 2.09, 95% CI 1.37 to 3.19, p <0.001) was associated with worse survival, whereas improvement in renal function was not associated with survival (hazard ratio vs unchanged eGFR 1.30, 95% CI 0.79 to 2.11, p = 0.30). Worsened renal function at 30 days after TAVI is associated with increased mortality after TAVI. In conclusion, monitoring renal function after discharge may identify patients at high risk of adverse outcomes., Competing Interests: Disclosures The authors have no conflicts of interest to declare., (Copyright © 2021 Elsevier Inc. All rights reserved.)
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- 2022
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34. Efficacy and safety of percutaneous patent foramen ovale closure in patients with a hypercoagulable disorder.
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Ben-Assa E, Herrero-Garibi J, Cruz-Gonzalez I, Elmariah S, Rengifo-Moreno P, Al-Bawardy R, Sakhuja R, Lima FV, Demirjian ZN, Ning M, Buonanno FS, Inglessis I, and Palacios IF
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- Cardiac Catheterization adverse effects, Humans, Recurrence, Treatment Outcome, Embolism, Paradoxical diagnosis, Embolism, Paradoxical etiology, Embolism, Paradoxical prevention & control, Foramen Ovale, Patent diagnosis, Foramen Ovale, Patent diagnostic imaging, Ischemic Attack, Transient diagnosis, Ischemic Attack, Transient etiology, Stroke diagnosis, Stroke etiology
- Abstract
Background: Transcatheter closure of patent foramen ovale (PFO) in patients with cryptogenic stroke reduces the rate of recurrent events. Although presence of thrombophilia increases the risk for paradoxical emboli through a PFO, such patients were excluded from large randomized trials., Objectives: We compared the safety and efficacy of percutaneous PFO closure in patients with and without a hypercoagulable state., Methods: Data from 800 consecutive patients undergoing percutaneous PFO closure in our medical center were analyzed. All patients were independently evaluated by specialists in neurology, cardiology, hematology, and vascular medicine. A post-procedural treatment of at least 3 months of anticoagulation was utilized in patients with thrombophilia. Follow-up events included death, recurrent neurological events, and the need for reintervention for significant residual shunt., Results: A hypercoagulable state was found in 239 patients (29.9%). At median follow-up of 41.9 months, there were no differences in the frequencies of stroke or transient ischemic attack between patients with or without thrombophilia (2.5% in non-hypercoagulable group vs. 3.4% in hypercoagulable group, log-rank test p = 0.35). There were no significant differences in baseline demographics, echocardiographic characteristics, procedural success, or complications between groups., Conclusion: Percutaneous PFO closure is a safe and effective therapeutic approach for patients with cryptogenic stroke and an underlying hypercoagulable state., (© 2021 Wiley Periodicals LLC.)
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- 2021
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35. Validation study to determine the accuracy of central blood pressure measurement using the SphygmoCor XCEL cuff device in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.
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De la Torre Hernández JM, Veiga Fernandez G, Brown J, Sainz Laso F, Lee DH, Fradejas V, Garcia Camarero T, Elmariah S, Inglessis I, Zueco J, Vazquez de Prada JA, Ben-Assa E, and Edelman ER
- Subjects
- Blood Pressure, Blood Pressure Determination, Humans, Aortic Valve Stenosis diagnosis, Aortic Valve Stenosis surgery, Hypertension diagnosis, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Central aortic blood pressure could be helpful in the evaluation of patients with aortic stenosis (AS). The SphygmoCor XCEL device estimates central blood pressure (BP) measurement with its easy-to-use, operator-independent procedure. However, this device has not been properly validated against invasive measurement in patients with severe AS. We evaluated the relationship between cuff-brachial BP, transfer function-estimated and invasively measured central aortic pressure in patients with severe AS before and after transcatheter aortic valve replacement (TAVR). Agreement between techniques was analyzed and, according to the ARTERY Society recommendations, the minimum acceptable error was a mean difference ± SD ≤5 ± ≤8 mm Hg. A total of 94 patients with AS undergoing TAVR had simultaneous non-invasive and invasive measurements of central BP before and after the procedure. Before TAVR central systolic BP was in average slightly underestimated, though with wide variability, when using the default calibration of brachial-cuff SBP (mean difference ± SD, -3 ± 15 mm Hg), and after TAVR the degree of underestimation increased (mean difference ± SD, -9 ± 13 mm Hg). The agreement tended to improve for those patients with low aortic gradient stenosis compared to those with high gradient at baseline (mean difference ± SD, -2 ± 11 mm Hg vs. -4 ± 17, respectively, p = .3). The cuff-brachial systolic BP yielded numerically lower degree of agreement and weaker correlation with invasive measurements than SphygmoCor XCEL. In patients with severe AS the SphygmoCor XCEL cuff device, despite showing strong correlation, does not meet the ARTERY Society accuracy criteria for non-invasive measurement of central SBP., (© © 2021 The Authors. The Journal of Clinical Hypertension published by Wiley Periodicals LLC.)
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- 2021
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36. Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes.
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Guerrero M, Pursnani A, Narang A, Salinger M, Wang DD, Eleid M, Kodali SK, George I, Satler L, Waksman R, Meduri CU, Rajagopal V, Inglessis I, Palacios I, Reisman M, Eng MH, Russell HM, Pershad A, Fang K, Kar S, Makkar R, Saucedo J, Pearson P, Bokhary U, Kaptzan T, Lewis B, Tommaso C, Krause P, Thaden J, Oh J, Lang RM, Hahn RT, Leon MB, O'Neill WW, Feldman T, and Rihal C
- Subjects
- Aged, Aged, 80 and over, Cardiac Catheterization adverse effects, Female, Humans, Male, Prospective Studies, Prosthesis Design, Treatment Outcome, Bioprosthesis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Annuloplasty
- Abstract
Objectives: The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial., Background: The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses., Methods: High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year)., Results: Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+., Conclusions: Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year., Competing Interests: Funding Support and Author Disclosures Dr. Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr. Wang has served as a consultant for Edwards Lifesciences and Boston Scientific; has received research grant support from Boston Scientific assigned to her employer, Henry Ford Health; and holds equity in Encompass Technologies. Dr. Kodali has served as a consultant for Admedus, Meril Lifesciences, Abbott Vascular, JenaValve, and Claret Medical; and has ownership interest in Dura Biotech, Thubrikar Aortic Valve, Micro Interventional Devices, and Supira Medical. Dr. George has served as consultant for Cardiomech, VDyne, MitreMedical, and Neptune Medical. Dr. Meduri has served as a consultant for Medtronic and Boston Scientific; and has served on the advisory board for Boston Scientific. Dr. Reisman has served as consultant for Edwards Lifesciences. Dr. Hahn has received speaker fees from Baylis Medical, Edwards Lifesciences, and Medtronic; is a consultant for Abbott Structural, Edwards Lifesciences, Gore & Associates, Medtronic, Navigate, and Philips Healthcare; has received nonfinancial support from 3mensio; holds equity in Navigate; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr. O’Neill has served as a consultant for Abiomed, Boston Scientific, and Edwards Lifesciences. Dr. Feldman is an employee of Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2021
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37. Impact of bleeding after transcatheter aortic valve replacement in patients with chronic kidney disease.
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Li SX, Patel NK, Flannery LD, Cigarroa RJ, Shaqdan AW, Erickson P, Tavil-Shatelyan A, Moses A, Inglessis I, and Elmariah S
- Subjects
- Aortic Valve diagnostic imaging, Aortic Valve surgery, Humans, Retrospective Studies, Risk Factors, Time Factors, Treatment Outcome, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Renal Insufficiency, Chronic complications, Renal Insufficiency, Chronic diagnosis, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Objective: In patients with chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR), this study aims to elucidate (a) the bleeding risks associated with CKD, (b) the association between bleeding and subsequent mortality, and (c) the pattern of antithrombotic therapy prescribed., Background: Patients with CKD have a higher risk of bleeding following TAVR. It is unclear whether this risk persists beyond the periprocedural period and whether it negatively impacts mortality., Methods: A retrospective review was performed on patients who underwent TAVR at Massachusetts General Hospital from 2008 to 2017. CKD was defined as estimated glomerular filtration rate less than 60 ml/min/1.73 m
2 . Primary endpoints up to 1-year following TAVR included bleeding, all-cause mortality, and ischemic stroke. Outcomes for patients with and without CKD were compared using log-rank test, and Cox regression with age, sex, and diabetes as covariates. Bleeding was treated as a time-varying covariate, and Cox proportional hazard regression was utilized to model mortality., Results: Of the 773 patients analyzed, 466 (60.3%) had CKD. At 1 year, CKD patients had higher rates of bleeding (9.2 vs. 4.9%, adjusted hazard ratios [aHR] = 1.91, p = .032) and all-cause mortality (13.7 vs. 9.1%, aHR = 1.57, p = .049), but not stroke (3.9 vs. 1.6% aHR = 0.073, p = .094). Bleeding was associated with an increased risk of subsequent mortality (aHR = 2.65, 95% CI: 1.25-5.63, p = .01). There were no differences in the antithrombotic strategy following TAVR between CKD and non-CKD patients., Conclusion: CKD is associated with a higher risk of bleeding up to 1 year following TAVR. Long-term bleeding after TAVR is associated with increased subsequent mortality., (© 2020 Wiley Periodicals, Inc.)- Published
- 2021
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38. Perforating the GORE® CARDIOFORM septal occluder and atrial septal defect occluder to gain access to the left atrium.
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Anderson JH, Adamson T, Migliati E, Herlihy J, Danieu P, Daly J, Allen C, Hua K, and Inglessis I
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- Animals, Dogs, Female, Male, Polytetrafluoroethylene, Prosthesis Design, Punctures, Time Factors, Cardiac Catheterization instrumentation, Cardiac Catheters, Catheter Ablation instrumentation, Heart Septum diagnostic imaging, Septal Occluder Device
- Abstract
Objective: Perforate the expanded polytetrafluoroethylene membrane of the GORE® CARDIOFORM Septal Occluder (GSO) and GORE® CARDIOFORM ASD Occluder (GCA) after implantation., Background: Percutaneous transseptal access to the left atrium is necessary for many structural and electrophysiological procedures. The potential need to access the left atrium may influence decision-making for patent foramen ovale or atrial septal defect closure., Methods: Sixteen canines underwent implantation of equal number GSO or GCA devices. A transseptal crossing procedure was performed through the device 85 (±1) days postoccluder implantation. The crossing procedure was performed utilizing commercially available equipment: radiofrequency/SureFlex sheath and standard needle/Mullin's sheath. Progressive dilation of the perforation was performed to allow passage of a 12 French Mullin's sheath into the left atrium., Results: Left atrial access was achieved in all cases. Postmortem analysis demonstrated passage through both occluder discs in all radiofrequency/SureFlex sheath cases (4 GSO, 4 GCA) and half of the standard needle/Mullin's sheath cases (3 GSO, 1 GCA). The remaining standard needle/Mullin's sheath cases demonstrated perforation through the right atrial disc but passage around the septal aspect of the left atrial disc, thus not perforating the left atrial disc. No acute embolic complications from the procedure were observed., Conclusions: Left atrial access may be achieved through the GSO or GCA devices after implantation and endothelialization. The combination of a radiofrequency needle and steerable sheath provides benefit over a standard needle and Mullin's sheath in accomplishing passage through both occluder discs., (© 2020 Wiley Periodicals, Inc.)
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- 2020
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39. Thirty-day readmissions after transcatheter versus surgical mitral valve repair in high-risk patients with mitral regurgitation: Analysis of the 2014-2015 Nationwide readmissions databases.
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Lima FV, Kolte D, Rofeberg V, Molino J, Zhang Z, Elmariah S, Aronow HD, Abbott JD, Ben Assa E, Khera S, Gordon PC, Inglessis I, and Palacios IF
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- Aged, Aged, 80 and over, Cardiac Catheterization instrumentation, Databases, Factual, Female, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation instrumentation, Humans, Male, Middle Aged, Mitral Valve diagnostic imaging, Mitral Valve physiopathology, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency physiopathology, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, United States, Cardiac Catheterization adverse effects, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve surgery, Mitral Valve Insufficiency surgery, Patient Readmission
- Abstract
Objective: Determine the rates, reasons, predictors, and costs of 30-day readmissions following transcatheter mitral valve repair (TMVR) versus surgical mitral valve repair (SMVR) in the United States., Background: Data on 30-day readmissions after TMVR are limited., Methods: High-risk patients with mitral regurgitation (MR) undergoing TMVR or SMVR were identified from the 2014-2015 Nationwide Readmissions Databases. Multivariable stepwise regression models were used to identify independent predictors of 30-day readmission. Risk of 30-day readmission was compared between the two groups using univariate and propensity score adjusted regression models., Results: Among 8,912 patients undergoing mitral valve repair during 2014-2015 (national estimate 17,809), we identified 7,510 (84.7%) that underwent SMVR and 1,402 (15.3%) that underwent TMVR. Thirty-day readmission rates after SMVR and TMVR were 10.7% and 11.7%, respectively (unadjusted OR 1.11, 95% CI 0.89-1.39, p = .35). After propensity score adjustment, TMVR was associated with a lower risk of 30-day readmissions compared with SMVR (adjusted OR 0.70, 95% CI 0.51-0.95, p = .02). Heart failure and arrhythmias were the leading cardiac reasons for readmission. Anemia and fluid and electrolyte disorder were independent predictors of 30-day readmission after TMVR. Demographics, comorbidities, and length of stay were independent predictors of 30-day readmission after SMVR., Conclusions: One in 10 patients are readmitted within 30 days following TMVR or SMVR. Approximately half of the readmissions are for cardiac reasons. The predictors of 30-day readmission are different among patients undergoing TMVR and SMVR, but can be easily screened for to identify patients at highest risk for readmission., (© 2019 Wiley Periodicals, Inc.)
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- 2020
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40. SCAI position statement on adult congenital cardiac interventional training, competencies and organizational recommendations.
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Aboulhosn JA, Hijazi ZM, Kavinsky CJ, McElhinney DB, Asgar AW, Benson LN, Daniels CJ, Ghobrial J, Horlick E, Ing FF, Inglessis I, Kay J, and Levi DS
- Subjects
- Clinical Competence, Consensus, Continuity of Patient Care, Curriculum, Heart Defects, Congenital diagnosis, Heart Defects, Congenital physiopathology, Humans, Cardiac Catheterization, Cardiologists education, Cardiology education, Education, Medical, Graduate, Heart Defects, Congenital therapy, Internship and Residency, Radiology, Interventional education, Survivors
- Published
- 2020
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41. Managing Severe Aortic Stenosis in the COVID-19 Era.
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Tanguturi VK, Lindman BR, Pibarot P, Passeri JJ, Kapadia S, Mack MJ, Inglessis I, Langer NB, Sundt TM, Hung J, and Elmariah S
- Subjects
- Aortic Valve Stenosis complications, Aortic Valve Stenosis mortality, Betacoronavirus, COVID-19, Coronavirus Infections epidemiology, Global Health, Hospital Mortality trends, Humans, Pneumonia, Viral epidemiology, Risk Factors, SARS-CoV-2, Aortic Valve surgery, Aortic Valve Stenosis surgery, Coronavirus Infections complications, Pandemics, Pneumonia, Viral complications, Transcatheter Aortic Valve Replacement methods
- Abstract
The novel coronavirus disease-2019 (COVID-19) pandemic has created uncertainty in the management of patients with severe aortic stenosis. This population experiences high mortality from delays in treatment of valve disease but is largely overlapping with the population of highest mortality from COVID-19. The authors present strategies for managing patients with severe aortic stenosis in the COVID-19 era. The authors suggest transitions to virtual assessments and consultation, careful pruning and planning of necessary testing, and fewer and shorter hospital admissions. These strategies center on minimizing patient exposure to COVID-19 and expenditure of human and health care resources without significant sacrifice to patient outcomes during this public health emergency. Areas of innovation to improve care during this time include increased use of wearable and remote devices to assess patient performance and vital signs, devices for facile cardiac assessment, and widespread use of clinical protocols for expedient discharge with virtual physical therapy and cardiac rehabilitation options., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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42. Temporal Trends in Prevalence of Tricuspid Valve Disease in Hospitalized Patients in the United States.
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Kolte D, Kennedy KF, Passeri JJ, Inglessis I, and Elmariah S
- Subjects
- Aged, Aged, 80 and over, Female, Heart Failure epidemiology, Humans, Male, Middle Aged, Prevalence, United States epidemiology, Heart Valve Diseases epidemiology, Hospitalization, Tricuspid Valve
- Abstract
Tricuspid valve disease (TVD), particularly tricuspid regurgitation, is a common valvular pathology that is associated with increased morbidity and mortality. The prevalence of TVD in hospitalized patients has not been well characterized. We used the National Inpatient Sample to determine the overall and age- and sex-specific prevalence and temporal trends in prevalence of TVD in hospitalized patients in the US. All-cause and heart failure (HF) hospitalizations in patients ≥50 years of age from January 2006 to September 2015 in the US were identified. Temporal trends in the prevalence of TVD were studied using Poisson regression. Of 194,184,433 all-cause and 38,083,773 HF hospitalizations in patients ≥50 years of age, 3,235,292 (1.7%) and 1,787,548 (4.7%) had a diagnosis of TVD, respectively. From 2006 to 2015, the prevalence of TVD in all hospitalizations and in HF hospitalizations increased from 1.7% to 2.0% and from 3.9% to 5.7%, respectively (p
trend <0.001 for both), particularly in those ≥85 years of age and in women. In patients with TVD, primary reasons for hospitalizations were HF (20.8%), infections (10.1%), arrhythmias (9.8%), respiratory conditions (8.4%), and coronary artery disease/acute myocardial infarction (8.2%). In-hospital mortality and length of stay in patients with TVD remained unchanged, whereas costs of hospitalization increased during the study period. In conclusion, the prevalence of TVD in all hospitalized patients and in those hospitalized with HF has increased over the past several years, particularly in those ≥85 years of age and in women. Approximately 1 in 5 hospitalizations with a diagnosis of TVD is due to HF., (Copyright © 2020 Elsevier Inc. All rights reserved.)- Published
- 2020
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43. Bioprosthetic Aortic Valve Leaflet Thickening in the Evolut Low Risk Sub-Study.
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Blanke P, Leipsic JA, Popma JJ, Yakubov SJ, Deeb GM, Gada H, Mumtaz M, Ramlawi B, Kleiman NS, Sorajja P, Askew J, Meduri CU, Kauten J, Melnitchouk S, Inglessis I, Huang J, Boulware M, and Reardon MJ
- Subjects
- Aged, Aged, 80 and over, Aortic Valve diagnostic imaging, Aortic Valve surgery, Echocardiography, Four-Dimensional trends, Female, Humans, Male, Prospective Studies, Risk Factors, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Bioprosthesis trends, Heart Valve Prosthesis trends, Prosthesis Design
- Abstract
Background: Subclinical leaflet thrombosis has been reported after bioprosthetic aortic valve replacement, characterized using 4-dimensional computed tomographic imaging by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM). The incidence and clinical implications of these findings remain unclear., Objectives: The aim of this study was to determine the frequency, predictors, and hemodynamic and clinical correlates of HALT and RLM after aortic bioprosthetic replacement., Methods: A prospective subset of patients not on oral anticoagulation enrolled in the Evolut Low Risk randomized trial underwent computed tomographic imaging 30 days and 1 year after transcatheter aortic valve replacement (TAVR) or surgery. The primary endpoint was the frequency of HALT at 30 days and 1 year, analyzed by an independent core laboratory using standardized definitions. Secondary endpoints included RLM, mean aortic gradient, and clinical events at 30 days and 1 year., Results: At 30 days, the frequency of HALT was 31 of 179 (17.3%) for TAVR and 23 of 139 (16.5%) for surgery; the frequency of RLM was 23 of 157 (14.6%) for TAVR and 19 of 133 (14.3%) for surgery. At 1 year, the frequency of HALT was 47 of 152 (30.9%) for TAVR and 33 of 116 (28.4%) for surgery; the frequency of RLM was 45 of 145 (31.0%) for TAVR and 30 of 111 (27.0%) for surgery. Aortic valve hemodynamic status was not influenced by the presence or severity of HALT or RLM at either time point. The rates of HALT and RLM were similar after the implantation of supra-annular, self-expanding transcatheter, or surgical bioprostheses., Conclusions: The presence of computed tomographic imaging abnormalities of aortic bioprostheses were frequent but dynamic in the first year after self-expanding transcatheter and surgical aortic valve replacement, but these findings did not correlate with aortic valve hemodynamic status after aortic valve replacement in patients at low risk for surgery. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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44. Effect of Residual Interatrial Shunt on Migraine Burden After Transcatheter Closure of Patent Foramen Ovale.
- Author
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Ben-Assa E, Rengifo-Moreno P, Al-Bawardy R, Kolte D, Cigarroa R, Cruz-Gonzalez I, Sakhuja R, Elmariah S, Pomerantsev E, Vaina LM, Ning M, Buonanno FS, Hung JW, Inglessis I, and Palacios IF
- Subjects
- Adult, Female, Foramen Ovale, Patent complications, Foramen Ovale, Patent diagnostic imaging, Foramen Ovale, Patent physiopathology, Humans, Male, Middle Aged, Migraine Disorders diagnosis, Migraine Disorders etiology, Migraine Disorders physiopathology, Retrospective Studies, Risk Factors, Septal Occluder Device, Time Factors, Treatment Outcome, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Coronary Circulation, Foramen Ovale, Patent therapy, Migraine Disorders prevention & control
- Abstract
Objectives: This study sought to evaluate the long-term effect of transcatheter patent foramen ovale (PFO) closure on migraineurs with and without aura and examine the effect of residual right-to-left shunt., Background: Many studies reported improvement in migraine symptoms after PFO closure, yet randomized trials failed to reach its clinical endpoints., Methods: The study retrospectively analyzed data from 474 patients who underwent transcatheter PFO closure at Massachusetts General Hospital. Patients completed a migraine burden questionnaire at baseline and at follow-up. Migraine severity is reported as migraine frequency (days/month), average duration (min), and migraine burden (days × min/month). Improvement following closure was defined as complete abolishment of symptoms or >50% reduction in migraine burden., Results: A total of 110 migraineurs who underwent PFO closure were included; 77.0% had aura and 23.0% were without aura, and 91.0% had a cryptogenic stroke. During long-term median follow-up of 3.2 (interquartile range: 2.1 to 4.9) years, there was a significant improvement in migraine symptoms in migraineurs with or without aura. Migraine burden was reduced by >50% in 87.0% of patients, and symptoms were completely abolished in 48%. Presence of aura was associated with abolishment of migraine (odds ratio: 4.30; 95% confidence interval: 1.50 to 12.30; p = 0.006). At 6 months after PFO closure, residual right-to-left shunt was present in 26% of patients. Absence of right-to-left shunt was associated with improvement in migraine burden by >50% (odds ratio: 4.60; 95% confidence interval: 1.30 to 16.10; p = 0.017)., Conclusions: Long-term follow-up after transcatheter PFO closure was associated with significant improvement in migraine burden. Aura was a predictor of abolishing symptoms. Absence of residual right-to-left shunt was a predictor of significant reduction in migraine burden., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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45. Clinical impact of post procedural mitral regurgitation after transcatheter aortic valve replacement.
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Ben-Assa E, Biner S, Banai S, Arbel Y, Laufer-Perl M, Kramarz J, Elmariah S, Inglessis I, Keren G, Finkelstein A, and Topilsky Y
- Subjects
- Aged, Aged, 80 and over, Echocardiography mortality, Echocardiography trends, Female, Follow-Up Studies, Humans, Male, Mitral Valve Insufficiency mortality, Mortality trends, Patient Readmission trends, Postoperative Complications etiology, Postoperative Complications mortality, Prospective Studies, Registries, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement mortality, Treatment Outcome, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery, Postoperative Complications diagnostic imaging, Transcatheter Aortic Valve Replacement trends
- Abstract
Background: While the impact of mitral regurgitation (MR) prior to transcatheter aortic valve replacement (TAVR) has been intensively studied, the implications of post-procedural MR on outcome are unknown. We investigated the clinical and physiological impact of significant MR after TAVR., Methods: Clinical and echocardiographic data of 486 patients who underwent TAVR between March 2009 and December 2014 were evaluated. Clinical endpoints included overall mortality and combined endpoint of mortality, heart failure re-hospitalization and new atrial fibrillation. Echocardiographic parameters were analyzed at baseline, 30-day and 6-month after TAVR., Results: MR severity improved in 25%, worsened in 19% and did not change in 56% of patients 30-days post TAVR (p = 0.3). Post TAVR MR grade ≥ moderate was present in 16.1%. Predictive accuracy of post TAVR MR was low (AUC = 0.63). Median follow-up was 4.3 years (interquartile range, 2.5 to 6.1). Post TAVR MR grade ≥ moderate was associated with increased mortality and combined cardiac events (p = 0.013 and p < 0.001) even when adjusted for all clinical and echo parameters and when analyzed with propensity score matching. In patients with MR ≥ moderate, LV filling pressure and RV hemodynamics worsened 6 months post TAVR, while improving in patients with less significant post procedural MR., Conclusion: Post procedural, but not pre-procedural MR grade ≥ moderate was independently associated with mortality and adverse cardiac events after TAVR. Significant MR post TAVR resulted in adverse LV and RV remodeling and poor hemodynamic. Our study strengthens the rational for initiating early treatment to reduce post TAVR MR., (Copyright © 2019 Elsevier B.V. All rights reserved.)
- Published
- 2020
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46. Association of Pulmonary Hypertension With Clinical Outcomes of Transcatheter Mitral Valve Repair.
- Author
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Al-Bawardy R, Vemulapalli S, Thourani VH, Mack M, Dai D, Stebbins A, Palacios I, Inglessis I, Sakhuja R, Ben-Assa E, Passeri JJ, Dal-Bianco JP, Yucel E, Melnitchouk S, Vlahakes GJ, Jassar AS, and Elmariah S
- Subjects
- Aged, Aged, 80 and over, Animals, Cohort Studies, Female, Heart Failure complications, Hospital Mortality, Humans, Hypertension, Pulmonary complications, Length of Stay, Male, Mitral Valve Insufficiency complications, Registries, Retrospective Studies, Severity of Illness Index, Cardiac Catheterization, Heart Failure physiopathology, Hypertension, Pulmonary physiopathology, Mitral Valve Annuloplasty, Mitral Valve Insufficiency surgery, Mortality, Patient Readmission statistics & numerical data
- Abstract
Importance: Pulmonary hypertension (pHTN) is associated with increased risk of mortality after mitral valve surgery for mitral regurgitation. However, its association with clinical outcomes in patients undergoing transcatheter mitral valve repair (TMVr) with a commercially available system (MitraClip) is unknown., Objective: To assess the association of pHTN with readmissions for heart failure and 1-year all-cause mortality after TMVr., Design, Setting, and Participants: This retrospective cohort study analyzed 4071 patients who underwent TMVr with the MitraClip system from November 4, 2013, through March 31, 2017, across 232 US sites in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry. Patients were stratified into the following 4 groups based on invasive mean pulmonary arterial pressure (mPAP): 1103 with no pHTN (mPAP, <25 mm Hg [group 1]); 1399 with mild pHTN (mPAP, 25-34 mm Hg [group 2]); 1011 with moderate pHTN (mPAP, 35-44 mm Hg [group 3]); and 558 with severe pHTN (mPAP, ≥45 mm Hg [group 4]). Data were analyzed from November 4, 2013, through March 31, 2017., Interventions: Patients were stratified into groups before TMVr, and clinical outcomes were assessed at 1 year after intervention., Main Outcomes and Measures: Primary end point was a composite of 1-year mortality and readmissions for heart failure. Secondary end points were 30-day and 1-year mortality and readmissions for heart failure. Linkage to Centers for Medicare & Medicaid Services administrative claims was performed to assess 1-year outcomes in 2381 patients., Results: Among the 4071 patients included in the analysis, the median age was 81 years (interquartile range, 73-86 years); 1885 (46.3%) were women and 2186 (53.7%) were men. The composite rate of 1-year mortality and readmissions for heart failure was 33.6% (95% CI, 31.6%-35.7%), which was higher in those with pHTN (27.8% [95% CI, 24.2%-31.5%] in group 1, 32.4% [95% CI, 29.0%-35.8%] in group 2, 36.0% [95% CI, 31.8%-40.2%] in group 3, and 45.2% [95% CI, 39.1%-51.0%] in group 4; P < .001). Similarly, 1-year mortality (16.3% [95% CI, 13.4%-19.5%] in group 1, 19.8% [95% CI, 17.0%-22.8%] in group 2, 22.4% [95% CI, 18.8%-26.1%] in group 3, and 27.8% [95% CI, 22.6%-33.3%] in group 4; P < .001) increased across pHTN groups. The association of pHTN with mortality persisted despite multivariable adjustment (hazard ratio per 5-mm Hg mPAP increase, 1.05; 95% CI, 1.01-1.09; P = .02)., Conclusions and Relevance: These findings suggest that pHTN is associated with increased mortality and readmission for heart failure in patients undergoing TMVr using the MitraClip system for severe mitral regurgitation. Further efforts are needed to determine whether earlier intervention before pHTN develops will improve clinical outcomes.
- Published
- 2020
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47. Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients.
- Author
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Kolte D, Vlahakes GJ, Palacios IF, Sakhuja R, Passeri JJ, Inglessis I, and Elmariah S
- Subjects
- Humans, Randomized Controlled Trials as Topic, Risk Assessment, Severity of Illness Index, Transcatheter Aortic Valve Replacement, Aortic Valve surgery, Aortic Valve Stenosis surgery, Heart Valve Prosthesis Implantation methods
- Abstract
Background: Transcatheter aortic valve replacement (TAVR) has emerged as a safe and effective therapeutic option for patients with severe aortic stenosis (AS) who are at prohibitive, high, or intermediate risk for surgical aortic valve replacement (SAVR). However, in low-risk patients, SAVR remains the standard therapy in current clinical practice., Objectives: This study sought to perform a meta-analysis of randomized controlled trials (RCTs) comparing TAVR versus SAVR in low-risk patients., Methods: Electronic databases were searched from inception to March 20, 2019. RCTs comparing TAVR versus SAVR in low-risk patients (Society of Thoracic Surgeons Predicted Risk of Mortality [STS-PROM] score <4%) were included. Primary outcome was all-cause death at 1 year. Random-effects models were used to calculate pooled risk ratio (RR) and corresponding 95% confidence interval (CI)., Results: The meta-analysis included 4 RCTs that randomized 2,887 patients (1,497 to TAVR and 1,390 to SAVR). The mean age of patients was 75.4 years, and the mean STS-PROM score was 2.3%. Compared with SAVR, TAVR was associated with significantly lower risk of all-cause death (2.1% vs. 3.5%; RR: 0.61; 95% CI: 0.39 to 0.96; p = 0.03; I
2 = 0%) and cardiovascular death (1.6% vs. 2.9%; RR: 0.55; 95% CI: 0.33 to 0.90; p = 0.02; I2 = 0%) at 1 year. Rates of new/worsening atrial fibrillation, life-threatening/disabling bleeding, and acute kidney injury stage 2/3 were lower, whereas those of permanent pacemaker implantation and moderate/severe paravalvular leak were higher after TAVR versus SAVR. There were no significant differences between TAVR versus SAVR for major vascular complications, endocarditis, aortic valve re-intervention, and New York Heart Association functional class ≥II., Conclusions: In this meta-analysis of RCTs comparing TAVR versus SAVR in low-risk patients, TAVR was associated with significantly lower risk of all-cause death and cardiovascular death at 1 year. These findings suggest that TAVR may be the preferred option over SAVR in low-risk patients with severe AS who are candidates for bioprosthetic AVR., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2019
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48. Ventricular stroke work and vascular impedance refine the characterization of patients with aortic stenosis.
- Author
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Ben-Assa E, Brown J, Keshavarz-Motamed Z, de la Torre Hernandez JM, Leiden B, Olender M, Kallel F, Palacios IF, Inglessis I, Passeri JJ, Shah PB, Elmariah S, Leon MB, and Edelman ER
- Subjects
- Aged, 80 and over, Aortic Valve Stenosis complications, Female, Hemodynamics, Humans, Hypertension complications, Hypertension physiopathology, Male, Pressure, Quality of Life, Aortic Valve Stenosis physiopathology, Electric Impedance, Heart Ventricles physiopathology
- Abstract
Aortic stenosis (AS) management is classically guided by symptoms and valvular metrics. However, the natural history of AS is dictated by coupling of the left ventricle, aortic valve, and vascular system. We investigated whether metrics of ventricular and vascular state add to the appreciation of AS state above valve gradient alone. Seventy patients with severe symptomatic AS were prospectively followed from baseline to 30 days after transcatheter aortic valve replacement (TAVR). Quality of life (QOL) was assessed using the Kansas City Cardiomyopathy Questionnaire. Left ventricular stroke work (SW
LV ) and vascular impedance spectrums were calculated noninvasively using in-house models based on central blood pressure waveforms, along with hemodynamic parameters from echocardiograms. Patients with higher preprocedural SWLV and lower vascular impedance were more likely to experience improved QOL after TAVR. Patients fell into two categories: those who did and those who did not exhibit increase in blood pressure after TAVR. In patients who developed hypertension (19%), vascular impedance increased and SWLV remained unchanged (impedance at zeroth harmonic: Z0 , from 3964.4 to 4851.8 dyne·s/cm3 , P = 0.039; characteristic impedance: Zc , from 376.2 to 603.2 dyne·s/cm3 , P = 0.033). SWLV dropped only in patients who did not develop new hypertension after TAVR (from 1.58 to 1.26 J; P < 0.001). Reduction in valvular pressure gradient after TAVR did not predict change in SWLV ( r = 0.213; P = 0.129). Reduction of SWLV after TAVR may be an important metric in management of AS, rather than relying solely on the elimination of transvalvular pressure gradients., (Copyright © 2019 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works.)- Published
- 2019
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49. Guidelines for the Evaluation of Valvular Regurgitation After Percutaneous Valve Repair or Replacement: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Angiography and Interventions, Japanese Society of Echocardiography, and Society for Cardiovascular Magnetic Resonance.
- Author
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Zoghbi WA, Asch FM, Bruce C, Gillam LD, Grayburn PA, Hahn RT, Inglessis I, Islam AM, Lerakis S, Little SH, Siegel RJ, Skubas N, Slesnick TC, Stewart WJ, Thavendiranathan P, Weissman NJ, Yasukochi S, and Zimmerman KG
- Subjects
- Cardiac Catheterization, Humans, Coronary Angiography standards, Echocardiography, Doppler standards, Heart Valve Diseases diagnostic imaging, Heart Valve Diseases surgery, Magnetic Resonance Imaging standards, Postoperative Complications diagnostic imaging
- Published
- 2019
- Full Text
- View/download PDF
50. Outcomes Following Urgent/Emergent Transcatheter Aortic Valve Replacement: Insights From the STS/ACC TVT Registry.
- Author
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Kolte D, Khera S, Vemulapalli S, Dai D, Heo S, Goldsweig AM, Aronow HD, Elmariah S, Inglessis I, Palacios IF, Thourani VH, Sharaf BL, Gordon PC, and Abbott JD
- Subjects
- Aged, Aged, 80 and over, Aortic Valve diagnostic imaging, Aortic Valve physiopathology, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis mortality, Aortic Valve Stenosis physiopathology, Emergencies, Female, Hemodynamics, Humans, Male, Registries, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, United States, Aortic Valve surgery, Aortic Valve Stenosis surgery, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement mortality
- Abstract
Objectives: The authors sought to examine outcomes and identify independent predictors of mortality among patients undergoing urgent/emergent transcatheter aortic valve replacement (TAVR)., Background: Data on urgent/emergent TAVR as a rescue therapy for decompensated severe aortic stenosis (AS) are limited., Methods: The Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry linked with Centers for Medicare & Medicaid Services claims was used to identify patients who underwent urgent/emergent versus elective TAVR between November 2011 and June 2016. Outcomes assessed were device success rate, in-hospital major adverse events, and 30-day and 1-year mortality. Independent predictors of mortality after urgent/emergent TAVR were examined., Results: Of 40,042 patients who underwent TAVR, 3,952 (9.9%) were urgent/emergent (median STS PROM score 11.8 [interquartile range: 7.6 to 17.9]). Device success rate was statistically lower, but not clinically different after urgent/emergent versus elective TAVR (92.6% vs. 93.7%; p = 0.007). Rates of major and/or life-threatening bleeding, major vascular complications, myocardial infarction, stroke, new permanent pacemaker placement, conversion to SAVR, and paravalvular regurgitation were similar between the 2 groups. Compared with elective TAVR, patients undergoing urgent/emergent TAVR had higher rates of acute kidney injury and/or new dialysis (8.2% vs. 4.2%; p < 0.001), 30-day mortality (8.7% vs. 4.3%, adjusted hazard ratio: 1.28, 95% confidence interval: 1.10 to 1.48), and 1-year mortality (29.1% vs. 17.5%, adjusted hazard ratio: 1.20, 95% confidence interval: 1.10 to 1.31). In patients undergoing urgent/emergent TAVR, non-femoral access and cardiopulmonary bypass were associated with increased risk, whereas use of balloon-expandable valve was associated with decreased risk of 30-day and 1-year mortality., Conclusions: Urgent/emergent TAVR is feasible with acceptable outcomes and may be a reasonable option in a selected group of patients with severe AS., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2018
- Full Text
- View/download PDF
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