458 results on '"Carmelo A. Milano"'
Search Results
2. Cardiac magnetic resonance imaging characterization of acute rejection in a porcine heterotopic heart transplantation model
- Author
-
Michelle Mendiola Pla, Carmelo A. Milano, Carolyn Glass, Dawn E. Bowles, and David C. Wendell
- Subjects
Medicine ,Science - Published
- 2024
3. Variation among organ procurement organizations in experience and practice of heart donation after circulatory deathCentral Message
- Author
-
Austin Ayer, BS, Benjamin S. Bryner, MD, MS, Chetan B. Patel, MD, Jacob N. Schroder, MD, Carmelo A. Milano, MD, Muath A. Bishawi, MD, PhD, Sarah Casalinova, BS, and Adam D. DeVore, MD, MHS
- Subjects
Diseases of the circulatory (Cardiovascular) system ,RC666-701 ,Surgery ,RD1-811 - Published
- 2023
- Full Text
- View/download PDF
4. Video analysis of ex vivo beating hearts during preservation on the TransMedics® organ care system
- Author
-
Michelle Mendiola Pla, Silvia Berrettoni, Franklin H. Lee, Giacomo Rozzi, Federica Marrano, Ryan T. Gross, Amy Evans, David C. Wendell, Paul Lezberg, Margherita Burattini, Francesco Paolo lo Muzio, Lorenzo Fassina, Carmelo A. Milano, Marie-Louise Bang, Dawn E. Bowles, and Michele Miragoli
- Subjects
ex vivo perfusion ,normothermic ,video ,kinematics ,biomarker ,cardiac transplantation ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
BackgroundReliable biomarkers for assessing the viability of the donor hearts undergoing ex vivo perfusion remain elusive. A unique feature of normothermic ex vivo perfusion on the TransMedics® Organ Care System (OCS™) is that the donor heart is maintained in a beating state throughout the preservation period. We applied a video algorithm for an in vivo assessment of cardiac kinematics, video kinematic evaluation (Vi.Ki.E.), to the donor hearts undergoing ex vivo perfusion on the OCS™ to assess the feasibility of applying this algorithm in this setting.MethodsHealthy donor porcine hearts (n = 6) were procured from Yucatan pigs and underwent 2 h of normothermic ex vivo perfusion on the OCS™ device. During the preservation period, serial high-resolution videos were captured at 30 frames per second. Using Vi.Ki.E., we assessed the force, energy, contractility, and trajectory parameters of each heart.ResultsThere were no significant changes in any of the measured parameters of the heart on the OCS™ device over time as judged by linear regression analysis. Importantly, there were no significant changes in contractility during the duration of the preservation period (time 0–30 min, 918 ± 430 px/s; time 31–60 min, 1,386 ± 603 px/s; time 61–90 min, 1,299 ± 617 px/s; time 91–120 min, 1,535 ± 728 px/s). Similarly, there were no significant changes in the force, energy, or trajectory parameters. Post-transplantation echocardiograms demonstrated robust contractility of each allograft.ConclusionVi.Ki.E. assessment of the donor hearts undergoing ex vivo perfusion is feasible on the TransMedics OCS™, and we observed that the donor hearts maintain steady kinematic measurements throughout the duration.
- Published
- 2023
- Full Text
- View/download PDF
5. Right and left ventricular assist devices are an option for bridge to heart transplantCentral MessagePerspective
- Author
-
Yaron D. Barac, MD, PhD, Ronen Toledano, MD, Oliver K. Jawitz, MD, Jacob N. Schroder, MD, Mani A. Daneshmand, MD, Chetan B. Patel, MD, Dan Aravot, MD, and Carmelo A. Milano, MD
- Subjects
heart transplantation ,LVAD ,RV failure ,UNOS ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 ,Surgery ,RD1-811 - Abstract
Background: Patients with a left ventricular assist device with right ventricular failure are prioritized on the heart transplant waitlist; however, their post-transplant survival is less well characterized. We aimed to determine whether pretransplant right ventricular failure affects postoperative survival in patients with a left ventricular assist device as a bridge to transplant. Methods: We performed a retrospective review of the 2005-2018 Organ Procurement and Transplantation Network/United Network for Organ Sharing registry for candidates aged 18 years or more waitlisted for first-time isolated heart transplantation after left ventricular assist device implantation. Candidates were stratified on the basis of having right ventricular failure, defined as the need for right ventricular assist device or intravenous inotropes. Baseline demographic and clinical characteristics were compared among the 3 groups, and post-transplant survival was assessed. Results: Our cohort included 5605 candidates who met inclusion criteria, including 450 patients with right ventricular failure, 344 patients with a left ventricular assist device and intravenous inotropes as a bridge to transplant, 106 patients with a left ventricular assist device and right ventricular assist device, and 5155 patients with a left ventricular assist device as a bridge to transplant without the need for right side support. Compared with patients without right ventricular failure, patients with a left ventricular assist device as a bridge to transplant with right ventricular failure were younger (median age 51 years, 55 vs 56 years, P 2) was an independent predictor of worse survival (hazard ratio, 1.74; 95% confidence interval, 1.39-2.17; P
- Published
- 2022
- Full Text
- View/download PDF
6. Heart transplant advances: Ex vivo organ-preservation systemsCentral Message
- Author
-
Benjamin S. Bryner, MD, Jacob N. Schroder, MD, and Carmelo A. Milano, MD
- Subjects
heart transplantation ,ex vivo heart perfusion ,organ perfusion ,organ recovery ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 ,Surgery ,RD1-811 - Published
- 2021
- Full Text
- View/download PDF
7. Characteristics of strokes associated with centrifugal flow left ventricular assist devices
- Author
-
Ovais Inamullah, Yuting P. Chiang, Muath Bishawi, Martin Weiss, Michael W. Lutz, Laura J. Blue, Wayne Feng, Carmelo A. Milano, Matthew Luedke, and Nada El Husseini
- Subjects
Medicine ,Science - Abstract
Abstract Stroke is a devastating complication of left ventricular assist device (LVAD) therapy. Understanding the characteristics, risk factors and outcomes of strokes associated with the centrifugal flow LVADs is important to devise better strategies for management and prevention. This is a retrospective cohort study at a single US academic medical center. The cohort includes patients who received a first time Heartmate 3 (HM3) or Heartware (HVAD) LVAD between September 2009 through February 2018 and had a stroke while the LVAD was in place. Descriptive statistics were used when appropriate. A logistic regression analysis was used to determine predictors of poor outcome. Out of a total of 247 patients, 12.1% (N = 30, 24 HVAD and 6 HM3) had a stroke (63% ischemic) and 3 of these patients had pump thrombosis. Events per patient year (EPPY) were similar for HVAD and HM3 patients (0.3 ± 0.1). INR was subtherapeutic in 47.4% of ischemic stroke patients and supratherapeutic in 18.2% of hemorrhagic stroke patients. Concurrent infections were more common in the setting of hemorrhagic stroke than ischemic stroke (45.4% vs 5.3%, p = 0.008). Strokes were severe in most cases, with initial NIH stroke scale (NIHSS) higher in HM3 patients compared to HVAD patients (mean 24.6 vs 16) and associated with high in-patient mortality (21.1% of ischemic stroke vs. 88.8% of hemorrhagic stroke). Predictors of death within 30 days and disability at 90 days included creatinine at stroke onset, concurrent infection, hemorrhaghic stroke, and initial stroke severity (NIHSS). A score derived from these variables predicted with 100% certainty mortality at 30 days and mRS ≥ 4 at 90 days. For patients with centrifugal flow LVADs, ischemic strokes were more common but hemorrhagic strokes were associated with higher in-patient mortality and more frequently seen in the setting of concurrent infections. Infections, sub or supratherapeutic INR range, and comorbid cardiovascular risk factors may all be contributing to the stroke burden. These findings may inform future strategies for stroke prevention in this population.
- Published
- 2021
- Full Text
- View/download PDF
8. A Case of Rare Inherited Restrictive Cardiomyopathy With Severe Biatrial Enlargement
- Author
-
Navid A. Nafissi, MD, Marat Fudim, MD, Carmelo A. Milano, MD, Paul B. Rosenberg, MD, Adam D. DeVore, MD, MHS, and Richa Agarwal, MD
- Subjects
cardiac transplant ,cardiomyopathy ,imaging ,genetic disorders ,restrictive ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
We describe a case of inherited restrictive cardiomyopathy in a patient presenting with severe biatrial enlargement. We review the evaluation and management of restrictive cardiomyopathy with a focus on genetic etiologies. (Level of Difficulty: Intermediate.)
- Published
- 2019
- Full Text
- View/download PDF
9. Heart Transplantation Survival and the Use of Traumatically Brain‐Injured Donors: UNOS Registry Propensity‐Matched Analysis
- Author
-
Yaron D. Barac, Oliver K. Jawitz, Jacob Klapper, Jacob Schroder, Mani A. Daneshmand, Chet Patel, Matt G. Hartwig, Nancy K. Sweitzer, and Carmelo A. Milano
- Subjects
heart transplant ,trauma brain injury ,UNOS ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background The transplantation of hearts from traumatically brain‐injured (TBI) donors has been associated with inferior long‐term survival in single‐center analyses. However, in a more recent analysis, death caused by cerebrovascular accident was associated with worse posttransplant survival in recipients. The purpose of this study was to explore the outcomes of heart transplantation in recipients receiving donor hearts from TBI and non‐TBI donors in a large national registry. Methods and Results We performed a retrospective cohort analysis of the UNOS (United Network of Organ Sharing) Registry Organ Procurement and Transplantation Network between 2006 and 2018 for adult candidates wait‐listed for isolated heart transplantation. Recipients were stratified into 2 groups, TBI and non‐TBI donors. Propensity score matching was performed. Kaplan‐Meier analysis was used to estimate survival posttransplant. A total of 24 894 candidates met inclusion criteria. TBI was the leading cause of death in the donor population. Recipients of TBI donor hearts (N=13 07) were younger (median age, 55 versus 57 years; P
- Published
- 2019
- Full Text
- View/download PDF
10. 3518 Bowel Ischemia after Continuous Flow Ventricular Assist Device Therapy: A Single Center Analysis
- Author
-
Ashley Y Choi, Jatin Anand, Muath Bishawi, Mani A. Daneshmand, Jacob N. Schroder, Suresh M. Agarwal, and Carmelo A. Milano
- Subjects
Medicine - Abstract
OBJECTIVES/SPECIFIC AIMS: The purpose of the study was to describe patient characteristics associated with subsequent development of bowel ischemia. Primary outcomes were survival to discharge, 30-day and 1-year survival in patients with LVAD who subsequently develop bowel ischemia. Secondary outcomes included characteristics of patients who survive to discharge after bowel ischemia and those who do not. These included markers of patient condition prior to surgical/endoscopic intervention such as lactate levels, ICU admission, ventilator dependence, vasopressor and renal replacement requirements, as well as presence of sepsis. Of these, we predicted that lactate levels and white blood cell count would be significantly elevated pre- and post-operatively in patients who do not recover from bowel ischemic event. We used Mann-Whitney U Test to examine lactate levels between the two groups as our sample size was
- Published
- 2019
- Full Text
- View/download PDF
11. Ex Vivo Gene Delivery to Porcine Cardiac Allografts Using a Myocardial-Enhanced Adeno-Associated Viral Vector
- Author
-
Michelle Mendiola Pla, Yuting Chiang, Antonio Roki, Chunbo Wang, Franklin H. Lee, Matthew F. Smith, Ryan T. Gross, Jun-Neng Roan, Muath Bishawi, Amy Evans, Lynden E. Gault, Sam Ho, Carolyn Glass, Jacob N. Schroder, Paul Lezberg, Carmelo A. Milano, and Dawn E. Bowles
- Subjects
Genetics ,Molecular Medicine ,Molecular Biology - Published
- 2023
12. Cardiovascular mechanism of donor brain death and heart recipient survival
- Author
-
Christopher W. Jensen, Oliver K. Jawitz, Abigail R. Benkert, Philip J. Spencer, Benjamin S. Bryner, Jacob N. Schroder, and Carmelo A. Milano
- Subjects
Pulmonary and Respiratory Medicine ,Surgery ,Cardiology and Cardiovascular Medicine - Published
- 2022
13. Late Durability of Mitral Repair for Ischemic Versus Nonischemic Functional Mitral Regurgitation
- Author
-
Jeffrey G. Gaca, Keith Carr, Andrew Wang, Muath Bishawi, Carmelo A. Milano, and Donald D. Glower
- Subjects
Pulmonary and Respiratory Medicine ,Surgical repair ,Mitral regurgitation ,medicine.medical_specialty ,Ejection fraction ,business.industry ,Regurgitation (circulation) ,medicine.disease ,Concomitant ,Heart failure ,Internal medicine ,Propensity score matching ,Etiology ,medicine ,Cardiology ,Surgery ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background Concerns regarding long-term durability of surgical repair for functional mitral regurgitation are based on short-term data, with few comparisons of ischemic (IMR) versus non-ischemic (NIFMR) etiology. Methods 788 consecutive patients receiving mitral repair for functional mitral regurgitation were evaluated from a prospectively maintained database. Patients with other surgical procedures were included. Propensity score matching was used to compare outcomes in IMR versus NIFMR. Results Unmatched IMR patients tended to be older men with greater comorbidities. 198 matched pairs of IMR versus NIFMR patients had similar demographics with relatively preserved ejection fraction 40±13% and end-systolic diameter 4.3±1.1cm. Concomitant coronary revascularization occurred in 70% of matched IMR patients. All patients received an annuloplasty ring, usually 24-26 mm. Heart failure class improved from 2.8 preop to 1.5 at 5 years (P =2+) mitral regurgitation (27±4% v 26±4%, P=0.4), severe regurgitation (10±3% v 8±2%, P=0.5), and mitral reoperation (3±1% v 3±1%, P=0.4) were not different between IMR v NIFMR. Recurrent moderate regurgitation was associated with heart failure readmission but not with mortality. Conclusions In propensity-matched patients, IMR versus NIFMR had worse survival but similar repair durability, with moderate regurgitation in 27% at 10 years and rare severe regurgitation or mitral reoperation. In selected patients with relatively preserved function, mitral repair for IMR or NIFMR can improve symptoms with durable mild regurgitation in most patients out to 10 years.
- Published
- 2022
14. Predictive capabilities of the European registry for patients with mechanical circulatory support right-sided heart failure risk score after left ventricular assist device implantation
- Author
-
Alina Nicoara, Mary Cooter Wright, Daniel Rosenkrans, Chetan B. Patel, Jacob N. Schroder, Anne D. Cherry, Nazish K. Hashmi, Angela L. Pollak, Sharon L. McCartney, Jason Katz, Carmelo A. Milano, and Mihai V. Podgoreanu
- Subjects
Adult ,Heart Failure ,Treatment Outcome ,Anesthesiology and Pain Medicine ,Risk Factors ,Ventricular Dysfunction, Right ,Humans ,Heart-Assist Devices ,Registries ,Cardiology and Cardiovascular Medicine ,Retrospective Studies - Abstract
The prediction of right heart failure (RHF) after left ventricular assist device (LVAD) implantation remains a challenge. Recently, risk scores were derived from analysis of the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) data, the EUROMACS-RHF, and the modified postoperative EUROMACS-RHF. The authors assessed the performance characteristics of these 2 risk score formulations in a continuous-flow LVAD cohort at their institution.A retrospective, observational study.At a tertiary-care academic medical center.Adult patients who underwent durable LVAD implantation between 2015 and 2018.None MEASUREMENTS AND MAIN RESULTS: Early post-LVAD RHF was defined as follows: (1) need for right ventricular assist device, or (2) inotropic or inhaled pulmonary vasodilator support for ≥14 postoperative days. The authors used logistic regression and examined receiver operating characteristic (ROC) curves to evaluate the ability of the 2 risk scores to distinguish between outcome groups. A total of 207 patients met the inclusion criteria. Of the patients, 16% developed RHF (33/207). The EUROMACS-RHF score was not predictive of RHF in the authors' cohort (odds ratio [OR] 1.25; 95% CI [0.99-1.60]; p = 0.06), but the postoperative EUROMACS-RHF CPB score was significantly associated (OR 1.38; 95% CI [1.03-1.89]; p = 0.03). The scores had similar ROC curves, with weak discriminatory performance: 0.601 (95% CI [0.509-0.692]) and 0.599 (95% CI [0.505-0.693]) for EUROMACS-RHF and postoperative EUROMACS-RHF, respectively.In the authors' single-center retrospective analysis, the EUROMACS-RHF risk score did not predict early RHF. An optimized risk score for the prediction of RHF after LVAD implantation remains an urgent unmet need.
- Published
- 2022
15. Incidence and Diagnostic Challenges of Bowel Ischemia after Continuous-flow Left Ventricular Assist Device Therapy
- Author
-
Michelle A Mendiola, Suresh M. Agarwal, Carmelo A. Milano, Jacob N. Schroder, Fabian Jimenez Contreras, Muath Bishawi, Jatin Anand, Cory Vatsaas, Ashley Y. Choi, Samantha E. Halpern, and Mani A. Daneshmand
- Subjects
Adult ,Male ,medicine.medical_specialty ,medicine.medical_treatment ,Biomedical Engineering ,Biophysics ,Bioengineering ,Article ,Biomaterials ,Ischemia ,medicine ,Humans ,Renal replacement therapy ,Stroke ,Retrospective Studies ,Heart Failure ,business.industry ,Incidence ,Atrial fibrillation ,General Medicine ,medicine.disease ,Surgery ,Treatment Outcome ,Ventricular assist device ,Current Procedural Terminology ,Female ,Kidney Diseases ,Heart-Assist Devices ,business ,Complication ,Kidney disease ,Destination therapy - Abstract
Long-term continuous-flow left ventricular assist device (CFLVAD) therapy is limited by complications. Compared with stroke and renal dysfunction, post-CFLVAD bowel ischemia is poorly characterized. Adult patients who underwent first-time durable CFLVAD implantation at our institution between 2008 and 2018 were identified and screened for bowel ischemia using Current Procedural Terminology codes for abdominal surgical exploration and International Classification of Disease codes for intestinal vascular insufficiency. Patients who developed biopsy-proven bowel ischemia (cases) were matched to controls (1:1, nearest neighbor, caliper = 0.29) based on preoperative characteristics. Incidences of postoperative right heart failure and renal replacement therapy were compared using McNemar's test. One year survival was estimated using the Kaplan-Meier method. Overall, 711 patients underwent CFLVAD implantation. Nineteen (2.7%) developed bowel ischemia (cases) median 17 days postimplantation (IQR 8-71). The majority of cases were male (78.9%), Black (63.2%), received HeartMate II (57.9%), treated as destination therapy (78.9%), and had a history of hypertension (89.5%), chronic kidney disease (84.2%), hyperlipidemia (84.2%), smoking (78.9%), and atrial fibrillation (57.9%). Post-LVAD, case patients were more likely to develop moderate-severe right heart failure (89.5% vs. 68.4%, p = 0.005), require renal replacement therapy (21.1% vs. 0%, p < 0.001), and less likely to survive to discharge (52.6% vs. 89.5%, p = 0.02) compared with controls. Case subjects demonstrated worse 1 year survival. While less common than stroke and renal dysfunction, post-CFLVAD bowel ischemia is associated with high 1 year mortality. Multi-institutional registries should consider reporting abdominal complications such as bowel ischemia as an adverse event to further investigate these trends and identify predictors of this complication to reduce patient mortality.
- Published
- 2023
16. 2022 ACC/AHA/HFSA Guideline for the Management of Heart Failure
- Author
-
Paul A. Heidenreich, Biykem Bozkurt, David Aguilar, Larry A. Allen, Joni J. Byun, Monica M. Colvin, Anita Deswal, Mark H. Drazner, Shannon M. Dunlay, Linda R. Evers, James C. Fang, Savitri E. Fedson, Gregg C. Fonarow, Salim S. Hayek, Adrian F. Hernandez, Prateeti Khazanie, Michelle M. Kittleson, Christopher S. Lee, Mark S. Link, Carmelo A. Milano, Lorraine C. Nnacheta, Alexander T. Sandhu, Lynne Warner Stevenson, Orly Vardeny, Amanda R. Vest, Clyde W. Yancy, Joshua A. Beckman, Patrick T. O'Gara, Sana M. Al-Khatib, Anastasia L. Armbruster, Kim K. Birtcher, Joaquin E. Cigarroa, Lisa de las Fuentes, Dave L. Dixon, Lee A. Fleisher, Federico Gentile, Zachary D. Goldberger, Bulent Gorenek, Norrisa Haynes, Mark A. Hlatky, José A. Joglar, W. Schuyler Jones, Joseph E. Marine, Daniel B. Mark, Debabrata Mukherjee, Latha P. Palaniappan, Mariann R. Piano, Tanveer Rab, Erica S. Spatz, Jacqueline E. Tamis-Holland, Duminda N. Wijeysundera, and Y. Joseph Woo
- Subjects
Heart Failure ,Research Report ,Cardiology ,Humans ,American Heart Association ,Cardiology and Cardiovascular Medicine ,United States - Abstract
The "2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure" replaces the "2013 ACCF/AHA Guideline for the Management of Heart Failure" and the "2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure." The 2022 guideline is intended to provide patient-centric recommendations for clinicians to prevent, diagnose, and manage patients with heart failure.A comprehensive literature search was conducted from May 2020 to December 2020, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from MEDLINE (PubMed), EMBASE, the Cochrane Collaboration, the Agency for Healthcare Research and Quality, and other relevant databases. Additional relevant clinical trials and research studies, published through September 2021, were also considered. This guideline was harmonized with other American Heart Association/American College of Cardiology guidelines published through December 2021.Heart failure remains a leading cause of morbidity and mortality globally. The 2022 heart failure guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with heart failure, with the intent to improve quality of care and align with patients' interests. Many recommendations from the earlier heart failure guidelines have been updated with new evidence, and new recommendations have been created when supported by published data. Value statements are provided for certain treatments with high-quality published economic analyses.
- Published
- 2022
17. Proteomic profiling identifies CLEC4C expression as a novel biomarker of primary graft dysfunction after heart transplantation
- Author
-
Carmelo A. Milano, Chetan B. Patel, Christopher L. Holley, Dawn E. Bowles, Lydia Coulter Kwee, Richa Agarwal, Dong-Feng Chen, Adam D. DeVore, Lauren K. Truby, Jacob N. Schroder, Svati H. Shah, and Elizabeth Grass
- Subjects
Male ,Proteomics ,Pulmonary and Respiratory Medicine ,Oncology ,medicine.medical_specialty ,medicine.medical_treatment ,Primary Graft Dysfunction ,Sensitivity and Specificity ,Article ,chemistry.chemical_compound ,Postoperative Complications ,Internal medicine ,Humans ,Medicine ,Lectins, C-Type ,Receptors, Immunologic ,Aged ,Aged, 80 and over ,Heart transplantation ,Transplantation ,Creatinine ,Membrane Glycoproteins ,business.industry ,Middle Aged ,Pathophysiology ,chemistry ,Heart Transplantation ,Biomarker (medicine) ,Population study ,Female ,Surgery ,Cardiomyopathies ,Cardiology and Cardiovascular Medicine ,Complication ,business ,Biomarkers - Abstract
PURPOSE: Clinical models to identify patients at high risk of primary graft dysfunction (PGD) after heart transplantation (HT) are limited, and the underlying pathophysiology of this common post-transplant complication remains poorly understood. We sought to identify whether pre-transplant levels of circulating proteins reporting on immune activation and inflammation are associated with incident PGD. METHODS: The study population consisted of 219 adult heart transplant recipients identified between 2016 and 2020 at Duke University Medical Center, randomly divided into derivation (n = 131) and validation (n = 88) sets. PGD was defined using modified ISHLT criteria. Proteomic profiling was performed using Olink panels (n = 354 proteins) with serum samples collected immediately prior to transplantation. Association between normalized relative protein expression and PGD was tested using univariate and multivariable (recipient age, creatinine, mechanical circulatory support, and sex; donor age; ischemic time) models. Significant proteins identified in the derivation set (p < 0.05 in univariate models), were then tested in the validation set. Pathway enrichment analysis was used to test candidate biological processes. The predictive performance of proteins was compared to that of the RADIAL score. RESULTS: Nine proteins were associated with PGD in univariate models in the derivation set. Of these, only CLEC4C remained associated with PGD in the validation set after Bonferroni correction (OR [95% CI] = 3.04 [1.74,5.82], p = 2.8×10(−4)). Patterns of association were consistent for CLEC4C in analyses stratified by biventricular/left ventricular and isolated right ventricular PGD. Pathway analysis identified interferon-alpha response and C-type lectin signaling as significantly enriched biologic processes. The RADIAL score was a poor predictor of PGD (AUC = 0.55). CLEC4C alone (AUC = 0.66, p = 0.048) and in combination with the clinical covariates from the multivariable model (AUC = 0.69, p = 0.018) improved discrimination for the primary outcome. CONCLUSIONS: Pre-transplantation circulating levels of CLEC4C, a protein marker of plasmacytoid dendritic cells (pDCs), may identify HT recipients at risk for PGD. Further studies are needed to better understand the potential role pDCs and the innate immune response in PGD.
- Published
- 2021
18. Transvenous Endomyocardial Biopsy Technique for Intra-abdominal Heterotopic Cardiac Grafts
- Author
-
Michelle Mendiola Pla, Carmelo A. Milano, Yuting Chiang, Muath Bishawi, Lillian Kang, Franklin H. Lee, Matthew F. Smith, Ryan T. Gross, Fabian Jimenez Contreras, Carolyn Glass, Dawn E. Bowles, and Marat Fudim
- Subjects
Genetics ,Pharmaceutical Science ,Molecular Medicine ,Cardiology and Cardiovascular Medicine ,Genetics (clinical) - Published
- 2022
19. Surgical Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation: Interim analysis of the TVVAD trial
- Author
-
Michelle Mendiola Pla, Yuting Chiang, Alina Nicoara, Emily Poehlein, Cynthia L. Green, Ryan Gross, Benjamin S. Bryner, Jacob N. Schroder, Mani A. Daneshmand, Stuart D. Russell, Adam D. DeVore, Chetan B. Patel, Jason N. Katz, Carmelo A. Milano, and Muath Bishawi
- Subjects
Pulmonary and Respiratory Medicine ,Surgery ,Cardiology and Cardiovascular Medicine - Published
- 2022
20. The outcome of mitral repair for degenerative versus ischemic mitral regurgitation using a single complete ring
- Author
-
Donald D. Glower, Jeffrey G. Gaca, Andrew Wang, Keith Carr, Carmelo A. Milano, and Muath Bishawi
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Mitral Valve Annuloplasty ,New york heart association ,Internal medicine ,medicine ,Humans ,Less urgent ,Surgical repair ,Mitral regurgitation ,Ischemic mitral regurgitation ,business.industry ,Mitral Valve Insufficiency ,Large cohort ,Treatment Outcome ,embryonic structures ,Etiology ,Cardiology ,Mitral Valve ,Female ,Surgery ,Tricuspid Valve ,Operative risk ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
The durability of surgical repair for degenerative versus ischemic mitral regurgitation (MR) is thought to be markedly different. We, therefore, examined late outcomes and durability for mitral repair in a large cohort of patients receiving a single annuloplasty device.A total of 749 consecutive patients receiving mitral repair for degenerative mitral regurgitation (DMR) or ischemic mitral regurgitation (IMR) were evaluated from a prospective database. Patients with tricuspid or maze surgery were included. Papillary muscle rupture and mixed valve etiologies were excluded. Outcomes were compared for IMR versus DMR.Patients with DMR were younger and less urgent. Patients with IMR had mean end-systolic diameter 4.5 ± 1.1 cm. All patients received the same complete semirigid annuloplasty device with median ring size 32 mm for DMR and 24 mm for IMR. New York Heart Association failure class improved from 2.8 to 1.5 (p .001). Patients with DMR had lower operative mortality (1/384 [0.3%] vs. 26/365 [7%], p .0001) and shorter length of stay. A 15-year survival was better with DMR (63% ± 3% vs. 13% ± 2%, p .001). At 10 years, the incidence of recurrent ≥2+ MR (10% ± 2% vs. 16% ± 2%, p = .16) was not significantly different. Predictors of recurrent ≥2+ MR were female gender (odds ratio [OR]: 3.0 (1.9-4.8, p .0001), and prior operation (OR: 2.4 [1.3-4.5], p = .02) but not IMR (OR: 1.4 [0.9-2.3], p = .15).In this series, where patients with IMR had relatively preserved ventricular dimensions, the primary determinants of late recurrent MR were female gender and prior operation but not IMR versus DMR. Selected patients with IMR can obtain relatively durable mitral repair despite higher operative risk and lower survival compared to DMR.
- Published
- 2021
21. Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients
- Author
-
Georg Wieselthaler, Joseph G. Rogers, Antone Tatooles, Gregory Macaluso, Carmelo A. Milano, Erika D. Feller, Mark S. Slaughter, and Francis D. Pagani
- Subjects
endocrine system ,medicine.medical_specialty ,Biomedical Engineering ,Biophysics ,Time in therapeutic range ,Hemorrhage ,Bioengineering ,Gastroenterology ,HVAD ,Biomaterials ,Therapeutic index ,Internal medicine ,Atrial Fibrillation ,left ventricular assist device ,medicine ,Humans ,International Normalized Ratio ,Thrombus ,Adverse effect ,Stroke ,biology ,business.industry ,Anticoagulants ,General Medicine ,medicine.disease ,Transthyretin ,Treatment Outcome ,time in therapeutic range ,Adult Circulatory Support ,ComputingMethodologies_DOCUMENTANDTEXTPROCESSING ,biology.protein ,destination therapy ,business ,Major bleeding ,Destination therapy - Abstract
Supplemental Digital Content is available in the text., The study aim was to examine the impact time in therapeutic range (TTR, International Normalized Ratio [INR] 2.0–3.0) has on survival and adverse events in patients receiving the HeartWare HVAD System in the ENDURANCE and ENDURANCE Supplemental Trials. Evaluable subjects (n = 495) had >1 INR value recorded 1–24 months postimplant and were categorized as: low TTR (10–39%), moderate TTR (40–69%), and high TTR (≥70%). Baseline characteristics, adverse events, and survival were analyzed. Low TTR patients experienced higher rates of major bleeding (1.69 vs. 0.54 events per patient year [EPPY]; p < 0.001), GI bleeding (1.22 vs. 0.38 EPPY; p < 0.001), stroke (0.47 vs. 0.17 EPPY; p < 0.001), thrombus requiring exchange (0.05 vs. 0.01 EPPY; p = 0.02), infection (1.44 vs. 0.69 EPPY; p < 0.001), and renal dysfunction (0.23 vs. 0.05 EPPY; p < 0.001) compared with high TTR. Moderate TTR had higher rates of major bleeding (0.75 vs. 0.54 EPPY; p < 0.001), thrombus requiring exchange (0.05 vs. 0.01 EPPY; p = 0.007), cardiac arrhythmia (0.32 vs. 0.24 EPPY; p = 0.04), and infection (0.90 vs. 0.69 EPPY; p = 0.001) compared with high TTR. Two year survival was greater among moderate and high versus low cohorts (Log-rank p = 0.001). The significant reduction in morbidity and mortality in destination therapy (DT) HVAD patients with well-controlled TTR (≥70%) emphasizes the importance of vigilant anticoagulation management.
- Published
- 2021
22. Cardiac computed tomography improves the identification of cardiomechanical complications among patients with suspected left ventricular assist device malfunction
- Author
-
Carmelo A. Milano, Chetan B. Patel, Lynne M. Hurwitz Koweek, Cynthia L. Green, Melissa A. Daubert, Priyesh A. Patel, Yuliya Lokhnygina, Jared D. Christensen, and Joseph G. Rogers
- Subjects
Male ,medicine.medical_specialty ,medicine.medical_treatment ,Regurgitation (circulation) ,030204 cardiovascular system & hematology ,Multimodal Imaging ,Ventricular Function, Left ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,Predictive Value of Tests ,Internal medicine ,Multidetector Computed Tomography ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Thrombus ,Aged ,Neointimal hyperplasia ,business.industry ,Reproducibility of Results ,Middle Aged ,equipment and supplies ,medicine.disease ,Prosthesis Failure ,Treatment Outcome ,Echocardiography ,Ventricular assist device ,Heart failure ,Circulatory system ,Cardiology ,Female ,Heart-Assist Devices ,Cardiology and Cardiovascular Medicine ,Complication ,business ,Heart Failure, Systolic - Abstract
Background Left ventricular assist devices (LVAD) are increasingly used for durable mechanical circulatory support in advanced heart failure. While LVAD therapy provides substantial improvement in mortality and quality of life, long-term therapy confers increased risk for device complications. We evaluated if cardiac computed tomography (CCT) improves the detection of cardiomechanical complications among patients with LVAD and suspected device malfunction. Methods In this study, we compared the diagnostic performance of CCT and transthoracic echocardiography (TTE) for the identification of cardiomechanical LVAD complications, including thrombus or neointimal hyperplasia, inflow cannula malposition with dynamic obstruction, fixed outflow obstruction, device infection, and severe aortic regurgitation. Complications were confirmed with surgical evaluation, pathologic assessment, or response to therapeutic intervention. Results Among 58 LVAD patients, who underwent CCT and TTE for suspected LVAD dysfunction, there were 49 confirmed cardiomechanical LVAD complications among 43 (74.1%) patients. The most common LVAD complication was thrombus or neointimal hyperplasia (65.3%), followed by dynamic obstruction (26.5%). Individually, CCT identified 29 of the 49 (59.2%) confirmed LVAD cardiomechanical complications, whereas TTE alone identified a complication in 11 cases (22.4%). However, diagnostic performance was greatest when the two modalities were used in combination, yielding a sensitivity of 67%, specificity of 93%, PPV of 97%, NPV of 47% and diagnostic accuracy of 73%. Conclusion The novel and complementary use of CCT with TTE for the evaluation of suspected device malfunction improves the accurate identification of cardiomechanical LVAD complication compared to either modality alone.
- Published
- 2021
23. Heart Transplantation Survival Outcomes of HIV Positive and Negative Recipients
- Author
-
Julie Doberne, Jacob N. Schroder, Carmelo A. Milano, Vignesh Raman, Benjamin S. Bryner, and Oliver K. Jawitz
- Subjects
Graft Rejection ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,medicine.medical_treatment ,Human immunodeficiency virus (HIV) ,HIV Infections ,030204 cardiovascular system & hematology ,medicine.disease_cause ,Article ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Survival analysis ,Immunosuppression Therapy ,Heart transplantation ,Proportional hazards model ,business.industry ,COVID-19 ,virus diseases ,medicine.disease ,Transplant Recipients ,030228 respiratory system ,Heart failure ,Propensity score matching ,Heart Transplantation ,Surgery ,Hiv status ,Cardiology and Cardiovascular Medicine ,Serostatus ,business ,Immunosuppressive Agents - Abstract
BACKGROUND: In the era of antiretroviral therapy, HIV-positive patients have reduced mortality from HIV infection and increased morbidity from end stage heart failure. The number of HIV-positive heart transplantation recipients remains scant. Long-term survival has not been rigorously studied. We compared survival outcomes of heart transplantation in HIV-positive recipients to HIV-negative recipients. METHODS: Clinical data from all adult heart transplantations were extracted from the UNOS Dataset. The impact of recipient HIV status was analyzed with Cox proportional hazards modeling, 1:3 propensity score matching and Kaplan-Meier survival analysis. RESULTS: Seventy-five HIV-positive recipients and 29,848 HIV-negative recipients were identified. Race distributions differed between the recipient groups, with Blacks comprising a larger proportion of the HIV-positive recipient group (46.7% versus 20.9%, p
- Published
- 2021
24. Conventional Ultrafiltration During Elective Cardiac Surgery and Postoperative Acute Kidney Injury
- Author
-
Carmelo A. Milano, Ian J. Welsby, Michael W. Manning, Dean Linder, John C. Haney, Yi-Hung Wu, Madhav Swaminathan, Mihai V. Podgoreanu, Kamrouz Ghadimi, Jacob N. Schroder, Mark Stafford-Smith, and Yi-Ju Li
- Subjects
Adult ,medicine.medical_specialty ,Ultrafiltration ,Blood volume ,030204 cardiovascular system & hematology ,urologic and male genital diseases ,Article ,law.invention ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Risk Factors ,030202 anesthesiology ,law ,Cardiopulmonary bypass ,Humans ,Medicine ,Prospective Studies ,Cardiac Surgical Procedures ,Prospective cohort study ,Retrospective Studies ,Cardiopulmonary Bypass ,business.industry ,Acute kidney injury ,Retrospective cohort study ,Acute Kidney Injury ,medicine.disease ,female genital diseases and pregnancy complications ,Cardiac surgery ,Anesthesiology and Pain Medicine ,Quartile ,Elective Surgical Procedures ,Anesthesia ,Cardiology and Cardiovascular Medicine ,business ,Kidney disease - Abstract
OBJECTIVE: Conventional ultrafiltration (CUF) during cardiopulmonary bypass (CPB) serves to hemoconcentrate blood volume to avoid allogeneic blood transfusions. Previous studies have determined weight-indexed CUF volumes as a continuous variable are associated with postoperative AKI after cardiac surgery but optimal weight-indexed volumes that predict AKI have not been described. DESIGN: Retrospective cohort SETTING: Single-center university hospital PARTICIPANTS: 1,641 consecutive patients that underwent elective cardiac surgery between June 2013-December 2015. INTERVENTIONS: CUF volume was removed during CPB in all participants as part of our routine practice. We investigated the association of dichotomized weight indexed CUF volume removal with postoperative AKI development to provide pragmatic guidance for clinical practice at our institution. MEASUREMENTS AND MAIN RESULTS: Primary outcomes of postoperative AKI was defined by the KDIGO staging criteria and dichotomized, weight indexed CUF volumes (ml/kg) were defined by (i) extreme quartiles (Q3) and by (ii) Youden’s criterion that best predicted AKI development. Multivariable logistic regression models were developed to test the association of these dichotomized indices with AKI status. Postoperative AKI occurred in 827 patients (50.4%). Higher CUF volumes were associated with AKI development by quartiles (CUF >Q(3)=32.6 vs. CUF 32 mL/kg increased the risk for postoperative AKI development. Importantly, CUF volume removal of any amount did not mitigate allogeneic blood transfusion during elective cardiac surgery. Prospective studies are needed to validate these findings.
- Published
- 2021
25. Improved Outcomes in Severe Primary Graft Dysfunction After Heart Transplantation Following Donation After Circulatory Death Compared With Donation After Brain Death
- Author
-
Austin Ayer, Lauren K. Truby, Jacob N. Schroder, Sarah Casalinova, Cynthia L. Green, Muath A. Bishawi, Benjamin S. Bryner, Carmelo A. Milano, Chetan B. Patel, and Adam D. Devore
- Subjects
Cardiology and Cardiovascular Medicine - Abstract
Primary graft dysfunction (PGD), the leading cause of early mortality after heart transplantation, is more common following donation after circulatory death (DCD) than donation after brain death (DBD). We conducted a single-center, retrospective cohort study to compare the incidence, severity and outcomes of patients experiencing PGD after DCD compared to DBD heart transplantation.Medical records were reviewed for all adult heart transplant recipients at our institution between March 2016 and December 2021. PGD was diagnosed within 24 hours after transplant according to modified International Society for Heart and Lung Transplant criteria. A total of 459 patients underwent isolated heart transplantation during the study period, 65 (14%) following DCD and 394 (86%) following DBD. The incidence of moderate or severe PGD in DCD and DBD recipients was 34% and 23%, respectively (P = 0.070). DCD recipients were more likely to experience severe biventricular PGD than DBD recipients (19% vs 7.4%; P = 0.004). Among patients with severe PGD, DCD recipients experienced shorter median (Q1, Q3) duration of post-transplant mechanical circulatory support (6 [4, 7] vs 9 [5, 14] days; P = 0.039), shorter median post-transplant hospital length of stay (17 [15, 29] vs 52 [26, 83] days; P = 0.004), and similar 60-day survival rates (100% [95% CI: 76.8%-100%] vs 80.0% [63.1%-91.6%]; P = 0.17) and overall survival (log-rank; P = 0.078) compared with DBD recipients.DCD heart transplant recipients were more likely to experience severe, biventricular PGD than DBD recipients. Despite this, DCD recipients with severe PGD spent fewer days on mechanical circulatory support and in the hospital than similar DBD patients. These findings suggest that patterns of graft dysfunction and recovery may differ between donor types, and they support the expansion of the heart-donor pool with DCD.
- Published
- 2022
26. Progression of Tricuspid Regurgitation After Surgery for Ischemic Mitral Regurgitation
- Author
-
Philippe B. Bertrand, Jessica R. Overbey, Xin Zeng, Robert A. Levine, Gorav Ailawadi, Michael A. Acker, Peter K. Smith, Vinod H. Thourani, Emilia Bagiella, Marissa A. Miller, Lopa Gupta, Michael J. Mack, A. Marc Gillinov, Gennaro Giustino, Alan J. Moskowitz, Annetine C. Gelijns, Michael E. Bowdish, Patrick T. O’Gara, James S. Gammie, Judy Hung, Wendy C. Taddei-Peters, Dennis Buxton, Ron Caulder, Nancy L. Geller, David Gordon, Neal O. Jeffries, Albert Lee, Claudia S. Moy, Ilana Kogan Gombos, Jennifer Ralph, Richard D. Weisel, Timothy J. Gardner, Eric A. Rose, Michael K. Parides, Deborah D. Ascheim, Ellen Moquete, Helena Chang, Melissa Chase, James Foo, Yingchun Chen, Seth Goldfarb, Katherine Kirkwood, Edlira Dobrev, Ron Levitan, Karen O’Sullivan, Jessica Overbey, Milerva Santos, Deborah Williams, Michael Weglinski, Paula Williams, Carrie Wood, Xia Ye, Sten Lyager Nielsen, Henrik Wiggers, Henning Malgaard, Michael Mack, Tracine Adame, Natalie Settele, Jenny Adams, William Ryan, Robert L. Smith, Paul Grayburn, Frederick Y. Chen, Anju Nohria, Lawrence Cohn, Prem Shekar, Sary Aranki, Gregory Couper, Michael Davidson, R. Morton Bolman, Anne Burgess, Debra Conboy, Rita Lawrence, Nicolas Noiseux, Louis-Mathieu Stevens, Ignacio Prieto, Fadi Basile, Joannie Dionne, Julie Fecteau, Eugene H. Blackstone, Pamela Lackner, Leoma Berroteran, Diana Dolney, Suzanne Fleming, Roberta Palumbo, Christine Whitman, Kathy Sankovic, Denise Kosty Sweeney, Carrie Geither, Kristen Doud, Gregory Pattakos, Pamela A. Clarke, Michael Argenziano, Mathew Williams, Lyn Goldsmith, Craig R. Smith, Yoshifumi Naka, Allan Stewart, Allan Schwartz, Daniel Bell, Danielle Van Patten, Sowmya Sreekanth, John H. Alexander, Carmelo A. Milano, Donald D. Glower, Joseph P. Mathew, J. Kevin Harrison, Stacey Welsh, Mark F. Berry, Cyrus J. Parsa, Betty C. Tong, Judson B. Williams, T. Bruce Ferguson, Alan P. Kypson, Evelio Rodriguez, Malissa Harris, Brenda Akers, Allison O'Neal, John D. Puskas, Robert Guyton, Jefferson Baer, Kim Baio, Alexis A. Neill, Pierre Voisine, Mario Senechal, François Dagenais, Kim O’Connor, Gladys Dussault, Tatiana Ballivian, Suzanne Keilani, Alan M. Speir, Patrick Magee, Niv Ad, Sally Keyte, Minh Dang, Mark Slaughter, Marsha Headlee, Heather Moody, Naresh Solankhi, Emma Birks, Mark A. Groh, Leslie E. Shell, Stephanie A. Shepard, Benjamin H. Trichon, Tracy Nanney, Lynne C. Hampton, Ralph Mangusan, Robert E. Michler, David A. D'Alessandro, Joseph J. DeRose, Daniel J. Goldstein, Ricardo Bello, William Jakobleff, Mario Garcia, Cynthia Taub, Daniel Spevak, Roger Swayze, Nadia Sookraj, Louis P. Perrault, Arsène-Joseph Basmadjian, Denis Bouchard, Michel Carrier, Raymond Cartier, Michel Pellerin, Jean François Tanguay, Ismail El-Hamamsy, André Denault, Philippe Demers, Sophie Robichaud Jonathan Lacharité, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Margaret Iraola, Ann Greenberg, Chittoor Sai-Sudhakar, Ayseha Hasan, Asia McDavid, Bradley Kinn, Pierre Pagé, Carole Sirois, David Latter, Howard Leong-Poi, Daniel Bonneau, Lee Errett, Mark D. Peterson, Subodh Verma, Randi Feder-Elituv, Gideon Cohen, Campbell Joyner, Stephen E. Fremes, Fuad Moussa, George Christakis, Reena Karkhanis, Terry Yau, Michael Farkouh, Anna Woo, Robert James Cusimano, Tirone David, Christopher Feindel, Lisa Garrard, Suzanne Fredericks, Amelia Mociornita, John C. Mullen, Jonathan Choy, Steven Meyer, Emily Kuurstra, Cindi A. Young, Dana Beach, Robert Villanueva, Pavan Atluri, Y. Joseph Woo, Mary Lou Mayer, Michael Bowdish, Vaughn A. Starnes, David Shavalle, Ray Matthews, Shadi Javadifar, Linda Romar, Irving L. Kron, Karen Johnston, John M. Dent, John Kern, Jessica Keim, Sandra Burks, Kim Gahring, David A. Bull, Patrice Desvigne-Nickens, Dennis O. Dixon, Mark Haigney, Richard Holubkov, Alice Jacobs, Frank Miller, John M. Murkin, John Spertus, Andrew S. Wechsler, Frank Sellke, Cheryl L. McDonald, Robert Byington, Neal Dickert, John S. Ikonomidis, David O. Williams, Clyde W. Yancy, James C. Fang, Nadia Giannetti, Wayne Richenbacher, Vivek Rao, Karen L. Furie, Rachel Miller, Sean Pinney, William C. Roberts, Mary N. Walsh, Niamh Kilcullen, David Hung, Stephen J. Keteyian, Clinton A. Brawner, Heather Aldred, Jeffrey Browndyke, and Yanne Toulgoat-Dubois
- Subjects
Male ,Pacemaker, Artificial ,medicine.medical_specialty ,medicine.medical_treatment ,Myocardial Ischemia ,030204 cardiovascular system & hematology ,Severity of Illness Index ,03 medical and health sciences ,0302 clinical medicine ,Recurrence ,medicine ,Humans ,Clinical significance ,Prospective Studies ,030212 general & internal medicine ,Stroke ,Aged ,Heart Failure ,Mitral valve repair ,business.industry ,Area under the curve ,Mitral Valve Insufficiency ,Atrial fibrillation ,medicine.disease ,Tricuspid Valve Insufficiency ,Defibrillators, Implantable ,Surgery ,Hospitalization ,Echocardiography ,Heart failure ,Disease Progression ,Female ,Tricuspid Valve ,Tricuspid Valve Regurgitation ,Cardiology and Cardiovascular Medicine ,Mitral valve regurgitation ,business ,Follow-Up Studies - Abstract
Whether to repair nonsevere tricuspid regurgitation (TR) during surgery for ischemic mitral valve regurgitation (IMR) remains uncertain.The goal of this study was to investigate the incidence, predictors, and clinical significance of TR progression and presence of ≥moderate TR after IMR surgery.Patients (n = 492) with untreated nonsevere TR within 2 prospectively randomized IMR trials were included. Key outcomes were TR progression (either progression by ≥2 grades, surgery for TR, or severe TR at 2 years) and presence of ≥moderate TR at 2 years.Patients' mean age was 66 ± 10 years (67% male), and TR distribution was 60% ≤trace, 31% mild, and 9% moderate. Among 2-year survivors, TR progression occurred in 20 (6%) of 325 patients. Baseline tricuspid annular diameter (TAD) was not predictive of TR progression. At 2 years, 37 (11%) of 323 patients had ≥moderate TR. Baseline TR grade, indexed TAD, and surgical ablation for atrial fibrillation were independent predictors of ≥moderate TR. However, TAD alone had poor discrimination (area under the curve, ≤0.65). Presence of ≥moderate TR at 2 years was higher in patients with MR recurrence (20% vs. 9%; p = 0.02) and a permanent pacemaker/defibrillator (19% vs. 9%; p = 0.01). Clinical event rates (composite of ≥1 New York Heart Association functional class increase, heart failure hospitalization, mitral valve surgery, and stroke) were higher in patients with TR progression (55% vs. 23%; p = 0.003) and ≥moderate TR at 2 years (38% vs. 22%; p = 0.04).After IMR surgery, progression of unrepaired nonsevere TR is uncommon. Baseline TAD is not predictive of TR progression and is poorly discriminative of ≥moderate TR at 2 years. TR progression and presence of ≥moderate TR are associated with clinical events. (Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting [CABG] Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation, NCT00806988; Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation, NCT00807040).
- Published
- 2021
27. Commentary: An innovative strategy for expanding the donor pool
- Author
-
Oliver K. Jawitz and Carmelo A. Milano
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,business.industry ,MEDLINE ,Medicine ,Surgery ,Cardiology and Cardiovascular Medicine ,business ,Intensive care medicine ,Donor pool - Published
- 2022
28. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines
- Author
-
Paul A. Heidenreich, Biykem Bozkurt, David Aguilar, Larry A. Allen, Joni J. Byun, Monica M. Colvin, Anita Deswal, Mark H. Drazner, Shannon M. Dunlay, Linda R. Evers, James C. Fang, Savitri E. Fedson, Gregg C. Fonarow, Salim S. Hayek, Adrian F. Hernandez, Prateeti Khazanie, Michelle M. Kittleson, Christopher S. Lee, Mark S. Link, Carmelo A. Milano, Lorraine C. Nnacheta, Alexander T. Sandhu, Lynne Warner Stevenson, Orly Vardeny, Amanda R. Vest, and Clyde W. Yancy
- Subjects
Heart Failure ,Research Report ,Physiology (medical) ,Cardiology ,Humans ,American Heart Association ,Cardiology and Cardiovascular Medicine ,Cardiovascular System ,United States - Abstract
Aim: The “2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure” replaces the “2013 ACCF/AHA Guideline for the Management of Heart Failure” and the “2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure.” The 2022 guideline is intended to provide patient-centric recommendations for clinicians to prevent, diagnose, and manage patients with heart failure. Methods: A comprehensive literature search was conducted from May 2020 to December 2020, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from MEDLINE (PubMed), EMBASE, the Cochrane Collaboration, the Agency for Healthcare Research and Quality, and other relevant databases. Additional relevant clinical trials and research studies, published through September 2021, were also considered. This guideline was harmonized with other American Heart Association/American College of Cardiology guidelines published through December 2021. Structure: Heart failure remains a leading cause of morbidity and mortality globally. The 2022 heart failure guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with heart failure, with the intent to improve quality of care and align with patients’ interests. Many recommendations from the earlier heart failure guidelines have been updated with new evidence, and new recommendations have been created when supported by published data. Value statements are provided for certain treatments with high-quality published economic analyses.
- Published
- 2022
29. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines
- Author
-
Paul A. Heidenreich, Biykem Bozkurt, David Aguilar, Larry A. Allen, Joni J. Byun, Monica M. Colvin, Anita Deswal, Mark H. Drazner, Shannon M. Dunlay, Linda R. Evers, James C. Fang, Savitri E. Fedson, Gregg C. Fonarow, Salim S. Hayek, Adrian F. Hernandez, Prateeti Khazanie, Michelle M. Kittleson, Christopher S. Lee, Mark S. Link, Carmelo A. Milano, Lorraine C. Nnacheta, Alexander T. Sandhu, Lynne Warner Stevenson, Orly Vardeny, Amanda R. Vest, and Clyde W. Yancy
- Subjects
Research Report ,Heart Failure ,Physiology (medical) ,Cardiology ,Humans ,American Heart Association ,Cardiology and Cardiovascular Medicine ,Cardiovascular System ,United States - Abstract
Aim: The “2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure” replaces the “2013 ACCF/AHA Guideline for the Management of Heart Failure” and the “2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure.” The 2022 guideline is intended to provide patient-centric recommendations for clinicians to prevent, diagnose, and manage patients with heart failure. Methods: A comprehensive literature search was conducted from May 2020 to December 2020, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from MEDLINE (PubMed), EMBASE, the Cochrane Collaboration, the Agency for Healthcare Research and Quality, and other relevant databases. Additional relevant clinical trials and research studies, published through September 2021, were also considered. This guideline was harmonized with other American Heart Association/American College of Cardiology guidelines published through December 2021. Structure: Heart failure remains a leading cause of morbidity and mortality globally. The 2022 heart failure guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with heart failure, with the intent to improve quality of care and align with patients’ interests. Many recommendations from the earlier heart failure guidelines have been updated with new evidence, and new recommendations have been created when supported by published data. Value statements are provided for certain treatments with high-quality published economic analyses.
- Published
- 2022
30. 2022 American College of Cardiology/American Heart Association/Heart Failure Society of America Guideline for the Management of Heart Failure: Executive Summary
- Author
-
Paul A, Heidenreich, Biykem, Bozkurt, David, Aguilar, Larry A, Allen, Joni-J, Byun, Monica M, Colvin, Anita, Deswal, Mark H, Drazner, Shannon M, Dunlay, Linda R, Evers, James C, Fang, Savitri E, Fedson, Gregg C, Fonarow, Salim S, Hayek, Adrian F, Hernandez, Prateeti, Khazanie, Michelle M, Kittleson, Christopher S, Lee, Mark S, Link, Carmelo A, Milano, Lorraine C, Nnacheta, Alexander T, Sandhu, Lynne Warner, Stevenson, Orly, Vardeny, Amanda R, Vest, and Clyde W, Yancy
- Subjects
Heart Failure ,Research Report ,Cardiology ,Humans ,American Heart Association ,United States - Abstract
The 2022 American College of Cardiology/American Heart Association/Heart Failure Society of America (AHA/ACC/HFSA) Guideline for the Management of Heart Failure replaces the 2013 ACCF/AHA Guideline for the Management of Heart Failure and the 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure. The 2022 guideline is intended to provide patient-centric recommendations for clinicians to prevent, diagnose and manage patients with heart failure.A comprehensive literature search was conducted from May 2020 to December 2020, encompassing studies, reviews and other evidence conducted in human subjects that were published in English from MEDLINE (PubMed), EMBASE, the Cochrane Collaboration, the Agency for Healthcare Research and Quality, and other relevant databases. Additional relevant clinical trials and research studies published through September 2021 were also considered. This guideline was harmonized with other American Heart Association/American College of Cardiology guidelines published through December 2021.Heart failure remains a leading cause of morbidity and mortality globally. The 2022 heart failure guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with heart failure, with the intent to improve quality of care and align with patients' interests. Many recommendations from the earlier heart failure guidelines have been updated with new evidence, and new recommendations have been created when supported by published data. Value statements are provided for certain treatments that have high-quality published economic analyses.
- Published
- 2022
31. The impact of perioperative stroke and delirium on outcomes after surgical aortic valve replacement
- Author
-
Steven R. Messé, Jessica R. Overbey, Vinod H. Thourani, Alan J. Moskowitz, Annetine C. Gelijns, Mark A. Groh, Michael J. Mack, Gorav Ailawadi, Karen L. Furie, Andrew M. Southerland, Michael L. James, Claudia Scala Moy, Lopa Gupta, Pierre Voisine, Louis P. Perrault, Michael E. Bowdish, A. Marc Gillinov, Patrick T. O'Gara, Maral Ouzounian, Bryan A. Whitson, John C. Mullen, Marissa A. Miller, James S. Gammie, Stephanie Pan, Guray Erus, Jeffrey N. Browndyke, Wendy C. Taddei-Peters, Neal O. Jeffries, Dennis Buxton, Nancy L. Geller, David Gordon, Catherine Burke, Albert Lee, Tyrone Smith, Claudia S. Moy, Ilana Kogan Gombos, Richard Weisel, Timothy J. Gardner, Eric A. Rose, Michael K. Parides, Deborah D. Ascheim, Emilia Bagiella, Ellen Moquete, Kinjal Shah, Helena Chang, Melissa Chase, Seth Goldfarb, Katherine Kirkwood, Edlira Dobrev, Ron Levitan, Karen O'Sullivan, Milerva Santos, Xia Ye, Michael Mack, Rachelle Winkle, Haley Boswell, Amanda Fenlon, Melissa Johnson, Jessica Jones, Megan Kolb, Sarah Lam, Lucy Miranda, Jackie Ward, Renessa Whitman, Brittany Zingler, William Ryan, Robert L. Smith, Paul Grayburn, Pedro Nosnik, Eugene H. Blackstone, Nader Moazami, Randall C. Starling, Benico Barzilai, Richard A. Grimm, Edward G. Soltesz, Irene Katzan, Brian Strippy, Shoi Smith, Michelle Garcia, Mary Alice bowman, Carrie Geither, Robert Wang, Michael Argenziano, Michael Borger, Hiroo Takayama, Martin B. Leon, Lyn Goldsmith, Allan Schwartz, Nadia Sookraj, Talaya McCright-Gill, Sowmya Sreekanth, Jock N. McCullough, Alexander Iribarne, Joseph P. DeSimone, Anthony W. DiScipio, Henry Stokes, Amanda St. Ivany, Gaylin Petty, Peter K. Smith, John H. Alexander, Carmelo A. Milano, Donald D. Glower, Joel Huber, Joel Morganlander, Joseph P. Mathew, Stacey Welsh, Sarah Casalinova, Victoria Johnson, Kathleen Lane, Derek Smith, Greg Tipton, Mark F. Berry, Judson B. Williams, Brian Englum, Matthew Hartwig, Robert Guyton, Omar Lattouf, Edward Chen, J. David Vega, Jefferson Baer, Duc Nguyen, Michael Halkos, Kim Baio, Tamara Prince, Natascha Cook, Alexis A. Neill, Mario Senechal, François Dagenais, Robert Laforce, Kim O'Connor, Gladys Dussault, Manon Caouette, Hugo Tremblay, Nathalie Gagne, Julie Dumont, Patricia Landry, Benjamin H. Trichon, Oliver A. Binns, Stephen W. Ely, Alan M. Johnson, Todd H. Hansen, John G. Short, Reid D. Taylor, Ralph Mangusan, Tracy Nanney, Holly Aubart, Kristin Cross, Leslie McPeters, Christina Riggsbee, Lucy Rixey, Robert E. Michler, Joseph J. DeRose, Daniel J. Goldstein, Ricardo A. Bello, Cynthia Taub, Daniel Spevack, Kathryn Kirchoff, Rebecca Meli, Juan Garcia, Jon Goldenberg, Lauren Kealy, Denis Bouchard, Jean François Tanguay, Eileen O'Meara, Jonathan Lacharité, Sophie Robichaud, Keith A. Horvath, Philip C. Corcoran, Michael P. Siegenthaler, Mandy Murphy, Margaret Iraola, Ann Greenberg, Greg Kumkumian, Mark Milner, Zurab Nadareishvili, Ayesha Hasan, Asia McDavid, Denise Fadorsen, Terry Yau, Michael Farkouh, Anna Woo, Robert James Cusimano, Tirone David, Christopher Feindel, Nishit Fumakia, Shakira Christie, Asvina Bissonauth, Alexandra Hripko, Zahid Noor, Kristen Mackowick, Stephanie Deasey, Manal Al-Suqi, Julia Collins, Michael A. Acker, Steven Messé, James Kirkpatrick, Mary Lou Mayer, Caitlin McDonald, Holley Fok, Breanna Maffei, Stephen Cresse, Christine Gepty, Michael Bowdish, Vaughn A. Starnes, David Shavalle, Christi Heck, Amy Hackmann, Craig Baker, Fernando Fleischman, Mark Cunningham, Edward Lozano, Michelle Hernandez, Irving L. Kron, Karen Johnston, Ravi K. Ghanta, John M. Dent, John Kern, Leora Yarboro, Michael Ragosta, Brian Annex, Jim Bergin, Sandra Burks, Mike Cosner, China Green, Samantha Loya, Hye Ryun Kim, David A. Bull, Patrice Desvigne-Nickens, Dennis O. Dixon, Rebecca Gottesman, Mark Haigney, Richard Holubkov, Constantino Iadecola, Alice Jacobs, Eric M. Meslin, John M. Murkin, John A. Spertus, Frank Sellke, Cheryl L. McDonald, John Canty, Neal Dickert, John S. Ikonomidis, KyungMann Kim, David O. Williams, Clyde W. Yancy, Seemant Chaturvedi, Marc Chimowitz, James C. Fang, Wayne Richenbacher, Vivek Rao, Rachel Miller, Jennifer Cook, David D'Alessandro, Frederick Han, Sean Pinney, Mary N. Walsh, David Greer, Koto Ishida, Christian Stapf, Judy Hung, Xin Zeng, David Hung, Sudarat Satitthummanid, Michel Billelo, Christos Davatzikos, Lauren Karpf, Lisa Desiderio, Yanne Toulgoat-Dubois, Rachele Brassard, Renu Virmanu, Maria E. Romero, and Ryan Braumann
- Subjects
Pulmonary and Respiratory Medicine ,Surgery ,Cardiology and Cardiovascular Medicine - Abstract
The effects of stroke and delirium on postdischarge cognition and patient-centered health outcomes after surgical aortic valve replacement (SAVR) are not well characterized. Here, we assess the impact of postoperative stroke and delirium on these health outcomes in SAVR patients at 90 days.Patients (N = 383) undergoing SAVR (41% received concomitant coronary artery bypass graft) enrolled in a randomized trial of embolic protection devices underwent serial neurologic and delirium evaluations at postoperative days 1, 3, and 7 and magnetic resonance imaging at day 7. Outcomes included 90-day functional status, neurocognitive decline from presurgical baseline, and quality of life.By postoperative day 7, 25 (6.6%) patients experienced clinical stroke and 103 (28.5%) manifested delirium. During index hospitalization, time to discharge was longer in patients experiencing stroke (hazard ratio, 0.62; 95% confidence interval [CI], 0.42-0.94; P = .02) and patients experiencing delirium (hazard ratio, 0.68; 95% CI, 0.54-0.86; P = .001). At day 90, patients experiencing stroke were more likely to have a modified Rankin score2 (odds ratio [OR], 5.9; 95% CI, 1.7-20.1; P = .01), depression (OR, 5.3; 95% CI, 1.6-17.3; P = .006), a lower 12-Item Short Form Survey physical health score (adjusted mean difference -3.3 ± 1.9; P = .08), and neurocognitive decline (OR, 7.8; 95% CI, 2.3-26.4; P = .001). Delirium was associated with depression (OR, 2.2; 95% CI, 0.9-5.3; P = .08), lower 12-Item Short Form Survey physical health (adjusted mean difference -2.3 ± 1.1; P = .03), and neurocognitive decline (OR, 2.2; 95% CI, 1.2-4.0; P = .01).Stroke and delirium occur more frequently after SAVR than is commonly recognized, and these events are associated with disability, depression, cognitive decline, and poorer quality of life at 90 days postoperatively. These findings support the need for new interventions to reduce these events and improve patient-centered outcomes.
- Published
- 2022
32. A Porcine Heterotopic Heart Transplantation Protocol for Delivery of Therapeutics to a Cardiac Allograft
- Author
-
Dawn E. Bowles, Carmelo A. Milano, Jacob N. Schroder, Benjamin S. Bryner, Paul Lezberg, Sam Ho, Desiree Bonadonna, Julie A. Balko, Lynden E. Gault, Alexis Carnes, Ryan Gross, Diego Zapata, Lillian Kang, Andrew Vekstein, Muath Bishawi, Yuting Chiang, Franklin H. Lee, Amy Evans, and Michelle Mendiola Pla
- Subjects
Graft Rejection ,Transplantation, Heterotopic ,General Immunology and Microbiology ,Swine ,General Chemical Engineering ,General Neuroscience ,Graft Survival ,Allografts ,Article ,Tissue Donors ,General Biochemistry, Genetics and Molecular Biology ,Animals ,Heart Transplantation ,Humans - Abstract
Cardiac transplantation remains the gold standard therapy for end stage heart failure. However, it remains limited by the number of available donor hearts and by complications such as primary graft dysfunction and graft rejection. The recent clinical use of an ex vivo perfusion device in cardiac transplantation introduces a unique opportunity for treating cardiac allografts with therapeutic interventions to improve function and avoid deleterious recipient responses. Establishing a translational, large-animal model for therapeutic delivery to the entire allograft is essential for testing novel therapeutic approaches in cardiac transplantation. The porcine, heterotopic heart transplantation model in the intra-abdominal position serves as an excellent model for assessing the effects of novel interventions as well as the immunopathology of graft rejection. This model additionally offers long-term survival for the pig given that the graft is not required to maintain the recipient’s circulation. The aim of this protocol is to provide a reproducible and robust approach for achieving ex vivo delivery of a therapeutic to the entire cardiac allograft prior to transplantation and provide technical details to perform a survival heterotopic transplant of the ex vivo perfused heart.
- Published
- 2022
33. A Case for Re-Gifting
- Author
-
Adam D. DeVore, Carmelo A. Milano, Richa Agarwal, Amanda C. Coniglio, Robert J. Mentz, Chetan B. Patel, and Jacob N. Schroder
- Subjects
0301 basic medicine ,medicine.medical_specialty ,medicine.diagnostic_test ,HLA, human leukocyte antigen ,business.industry ,imaging ,systolic heart failure ,Ischemic time ,Case Report ,030105 genetics & heredity ,Surgery ,Transplantation ,03 medical and health sciences ,surgical procedures, operative ,0302 clinical medicine ,HLA - Human leukocyte antigen ,medicine ,Clinical Case: Editor's Highlights ,HT, heart transplantation ,MFI, mean fluorescence intensity ,cardiac transplant ,Cardiology and Cardiovascular Medicine ,business ,Tissue typing ,030217 neurology & neurosurgery - Abstract
Many patients die while waiting for a heart transplant. Therefore, it is vital that all suitable organs are used for transplantation. We present a case of an allograft that was transplanted twice and outline considerations regarding tissue typing, the impact of repeated ischemic time, and ethical considerations with allograft retransplantation. (Level of Difficulty: Intermediate.), Central Illustration
- Published
- 2021
34. Cardiovascular Implantable Electronic Device Surgery Following Left Ventricular Assist Device Implantation
- Author
-
Michael Rehorn, Chetan B. Patel, James P. Daubert, Jason N. Katz, Eric Black-Maier, Muath Bishawi, Camille Frazier-Mills, Sean D. Pokorney, Daniel J. Friedman, Joseph G. Rogers, Kevin P. Jackson, Robert K. Lewis, Jacob N. Schroder, Rahul S. Loungani, Jonathan P. Piccini, Carmelo A. Milano, and Donald D. Hegland
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Hematoma ,Interquartile range ,Humans ,Medicine ,030212 general & internal medicine ,Retrospective Studies ,business.industry ,Arrhythmias, Cardiac ,Retrospective cohort study ,equipment and supplies ,medicine.disease ,Implantable cardioverter-defibrillator ,University hospital ,Defibrillators, Implantable ,Surgery ,Ventricular assist device ,Cohort ,Heart-Assist Devices ,Implant ,Electronics ,business - Abstract
This study sought to determine the indications, characteristics, and outcomes of cardiovascular implantable electronic device (CIED) surgery in patients with LVAD.Many patients with a left ventricular assist device (LVAD) will require implantable cardioverter-defibrillator generator change or device revision or are candidates for de novo implantable cardioverter-defibrillator implantation following LVAD implantation.We performed an observational retrospective study of all LVAD recipients who subsequently underwent CIED surgery at Duke University Hospital from 2009 to 2019.A total of 159 patients underwent CIED surgery following LVAD implantation, including generator change (n = 93), device revision (n = 38), and de novo implant (n = 28). The median (interquartile range) time from LVAD implantation to CIED surgery was 18.1 months (5.5 to 35.1 months). Pre-operative risk for infection was elevated in the overall cohort with a median (interquartile range) Prevention of Arrhythmia Device Infection Trial (PADIT) score of 7.0 (5.0 to 9.0). Pocket hematoma occurred in 21 patients (13.2%) following CIED surgery. Antimicrobial envelops were used in 43 patients (27%). Device infection due to CIED surgery occurred in 5 (3.1%) patients and occurred only in patients who developed post-operative pocket hematoma (p 0.001). Mortality at 1 year following CIED surgery was 20% (n = 32).CIED surgery following LVAD implantation is associated with an increased risk for pocket hematoma and CIED infection. Further studies are needed to determine the risk-benefit ratio of CIED surgery in patients with LVADs.
- Published
- 2020
35. OptiVol for Volume Assessment in Patients With Continuous Flow Left Ventricular Assist Device
- Author
-
Sana M. Al-Khatib, Robert J. Mentz, Karen Chiswell, Angela Lowenstern, Jacob N. Schroder, Joseph G. Rogers, Carmelo A. Milano, Lauren B. Cooper, Robert M. Clare, and Emily P. Zeitler
- Subjects
Adult ,Male ,medicine.medical_specialty ,medicine.medical_treatment ,Population ,Biomedical Engineering ,Biophysics ,Volume overload ,Bioengineering ,030204 cardiovascular system & hematology ,Cardiography, Impedance ,Biomaterials ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Medical history ,In patient ,education ,Retrospective Studies ,Heart Failure ,education.field_of_study ,Heartmate ii ,Continuous flow ,business.industry ,General Medicine ,Middle Aged ,medicine.disease ,Body Fluids ,Defibrillators, Implantable ,030228 respiratory system ,Heart failure ,Ventricular assist device ,Cardiology ,Female ,Heart-Assist Devices ,business - Abstract
OptiVol (Medtronic PLC, Minneapolis, MN) is a diagnostic feature of some cardiac implantable electronic devices (CIEDs) based on changes in thoracic impedance (TI) over time. Changes in TI can predict heart failure (HF) hospitalizations and mortality in HF populations. However, the utility of this feature is unknown in patients with a left ventricular assist device (LVAD). To determine if OptiVol and TI correlate with clinical HF events in a population of LVAD patients, hospitalization outcomes were collected retrospectively from the electronic health records at a single academic medical center in 80 LVAD patients with an OptiVol-capable CIED. Demographics, medical history, and available clinical data were reviewed and reported. The primary outcomes of interest were TI and OptiVol trends before and after hospitalization, and association of trends before and after these events was evaluated. Most patients had a HeartMate II LVAD and most CIEDs were defibrillators, and 23 (29%) had at least one HF hospitalization during the study period. HF hospitalizations were preceded by signs of volume overload in Optivol (60%) and TI (78%) with recovery of these measures post hospitalization in 33% and 25% of patients, respectively. Monitoring of TI and OptiVol may be one effective component of HF management in LVAD patients as part of a comprehensive program.
- Published
- 2020
36. Increased Calculated Panel Reactive Antigen Is Associated With Increased Waitlist Time and Mortality in Lung Transplantation
- Author
-
Dong-Feng Chen, Jacob A. Klapper, Mani A. Daneshmand, Michael S. Mulvihill, Matthew G. Hartwig, Yaron D. Barac, Basil S. Nasir, Carmelo A. Milano, Oliver K. Jawitz, and John C. Haney
- Subjects
Pulmonary and Respiratory Medicine ,United Network for Organ Sharing ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Hazard ratio ,030204 cardiovascular system & hematology ,Confidence interval ,Organ transplantation ,Transplantation ,03 medical and health sciences ,Organ procurement ,0302 clinical medicine ,030228 respiratory system ,Antigen ,Internal medicine ,Medicine ,Lung transplantation ,Surgery ,Cardiology and Cardiovascular Medicine ,business - Abstract
Background Sensitized candidates with unacceptable antigens are a group that demands special attention in organ transplantation. Calculated panel reactive antigen (cPRA) is not used to modify allocation priorities in lung transplantation. The impact of cPRA on waiting list time and mortality is unknown. Methods We performed a retrospective review of candidates for lung transplantation listed from May 2005 to 2018. Data from the Organ Procurement and Transplantation Network/United Network for Organ Sharing STAR (Standard Analysis and Research) dataset was paired with additional unacceptable human leukocyte antigen (UA-HLA) data, which were used to calculate the listing cPRA. Candidates were stratified based on the lack of UA-HLAs or cPRA level for candidates with unacceptable antigens reported. Unadjusted competing risks and adjusted subdistribution hazard models were fit. Results A total of 29,085 candidates met inclusion criteria for analysis. Of these, 23,562 (81%) with no UA-HLAs, 3472 (11.9%) with a cPRA less than 50, and 2051 with a cPRA greater than or equal to 50 (7.1%). On adjusted analysis, a cPRA greater than or equal to 50 was independently associated with increased waitlist mortality at 1 year (hazard ratio, 1.71; 95% confidence interval, 1.55-1.88; P Conclusions Further evaluation of organ allocation with consideration of a candidate's cPRA may be warranted in order to optimize equity in access to transplants.
- Published
- 2020
37. Surgical infection prophylaxis prior to left ventricular assist device implantation: A survey of clinical practice
- Author
-
Rachel Miller, Carmelo A. Milano, Muath Bishawi, Ahmad Mourad, Stacey A. Maskarinec, and Sana Arif
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Prosthesis-Related Infections ,medicine.medical_treatment ,Levofloxacin ,030204 cardiovascular system & hematology ,Prosthesis Implantation ,Aztreonam ,03 medical and health sciences ,0302 clinical medicine ,Vancomycin ,Surveys and Questionnaires ,Internal medicine ,medicine ,Humans ,Surgical Wound Infection ,Fluconazole ,business.industry ,Antibiotic Prophylaxis ,Antimicrobial ,Anti-Bacterial Agents ,Cephalosporins ,Clinical Practice ,Transplantation ,Regimen ,Cross-Sectional Studies ,030228 respiratory system ,Ventricular assist device ,Drug Therapy, Combination ,Surgery ,Heart-Assist Devices ,Rifampin ,Cardiology and Cardiovascular Medicine ,business ,Surgical Infections ,medicine.drug - Abstract
Background Short duration, antimicrobial prophylaxis that includes antistaphylococcal activity is recommended at the time of left ventricular assist device (LVAD) implantation to reduce infection-related complications. There continues to be wide variability in surgical infection prophylaxis (SIP) regimens among implantation centers. The aim of this study is to characterize current SIP regimens at different LVAD centers. Methods A survey study was conducted from 26 September 2017 to 25 October 2017. Surveys were distributed electronically to LVAD coordinators and infectious diseases specialists at 75 US medical centers identified as having an LVAD program. Data collection included information about antimicrobial selection, duration, Staphylococcus aureus screening, and decolonization procedures. Results We received 29 survey responses. The majority of surveys were completed by infectious diseases physicians (72.4% [21 out of 29]). Most responding centers reported LVAD programs established for greater than 10 years (20 out of 29 [69%]). Cardiac transplantation was performed in 28 out of 29 (96%) centers. Of centers reporting a defined SIP regimen for non-penicillin allergic patients (96% [28 out of 29]), 17.9% (5 out of 28) reported a four-drug regimen, 35.7% (10 out of 28) reported a three-drug regimen, and 46.4% (13 out of 28) reported a two-drug regimen, while no centers reported a single-drug regimen. Empiric fluconazole was common (50% [14 out of 28]) and 96.4% (27 out of 28) of regimens included vancomycin. Duration of antimicrobial prophylaxis (24 hours to 5 days), S. aureus screening, decolonization procedures, and alterations due to drug allergies varied across participating centers. Conclusions Our survey results indicate wide variation in SIP regimens among participating LVAD centers. These results highlight the need for studies evaluating the implications of SIP regimens, and whether clinical factors that prolong antimicrobial duration impact postoperative infection rates.
- Published
- 2020
38. Reassessing Recipient Mortality Under the New Heart Allocation System
- Author
-
Carmelo A. Milano, Jacob N. Schroder, Vignesh Raman, Joseph G. Rogers, Robert J. Mentz, Marat Fudim, Chetan B. Patel, Adam D. DeVore, Benjamin S. Bryner, and Oliver K. Jawitz
- Subjects
Heart transplantation ,United Network for Organ Sharing ,medicine.medical_specialty ,Proportional hazards model ,business.industry ,medicine.medical_treatment ,Hazard ratio ,030204 cardiovascular system & hematology ,medicine.disease ,Confidence interval ,03 medical and health sciences ,0302 clinical medicine ,Heart failure ,Emergency medicine ,medicine ,030212 general & internal medicine ,Cardiology and Cardiovascular Medicine ,business ,Survival rate ,Survival analysis - Abstract
Background An early report of recipient heart transplantation outcomes under the new U.S. heart allocation system introduced in late 2018 found a lower post-transplant survival rate compared with that of the prior system. Objectives The aim of this study was to examine recipient survival under the new system by using an updated dataset. Methods The 2015 to 2019 United Network for Organ Sharing registry was queried for adult heart transplant recipients, stratified according to whether the subjects were listed and underwent transplant before or after October 18, 2018, when the new allocation system was implemented. The association between allocation system and recipient mortality was analyzed by using the Kaplan-Meier method and multivariable Cox proportional hazards regression. Results A total of 7,119 recipients met inclusion criteria: 6,004 (84%) and 1,115 (16%) listed and undergoing transplant in the old and new allocation systems, respectively. This registry update included 576 new-system recipients, more than double the amount previously analyzed. Recipients from the new system were more likely to be bridged to transplant with temporary mechanical circulatory support devices instead of durable left ventricular assist devices and had longer graft ischemic times. After adjustment, the new system was not associated with poorer survival on Kaplan-Meier survival analysis (log-rank test; p = 0.075) or multivariable Cox proportional hazards modeling (adjusted hazard ratio: 1.18; 95% confidence interval: 0.90 to 1.55). Conclusions The short-term survival of recipients listed and receiving a transplant under the old and new allocation systems seems to be comparable. The modification to the allocation system has resulted in several changes to the clinical profiles of patients undergoing transplants that must be closely monitored in the coming years.
- Published
- 2020
39. Lead Extraction for Cardiovascular Implantable Electronic Device Infection in Patients With Left Ventricular Assist Devices
- Author
-
Robert K. Lewis, John C. Haney, Donald D. Hegland, Carmelo A. Milano, Sean D. Pokorney, Jacob N. Schroder, Vance G. Fowler, Alina Nicoara, Eric Black-Maier, Jonathan P. Piccini, James P. Daubert, Jason N. Katz, Benjamin S. Bryner, and Muath Bishawi
- Subjects
medicine.medical_specialty ,Endocarditis ,business.industry ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,medicine.disease ,Defibrillators, Implantable ,Surgery ,03 medical and health sciences ,0302 clinical medicine ,Interquartile range ,Ventricular assist device ,Bacteremia ,Humans ,Medicine ,Heart-Assist Devices ,030212 general & internal medicine ,Implant ,Electronics ,business ,Lead (electronics) ,Adverse effect ,Retrospective Studies ,Lead extraction - Abstract
Objectives The goal of this study was to assess the utility of transvenous lead extraction for cardiovascular implantable electronic device (CIED) infection in patients with a left ventricular assist device (LVAD). Background The utility of transvenous lead extraction for the management CIED infection in patients with a durable LVAD has not been well described. Methods Clinical and outcomes data were collected retrospectively among patients who underwent lead extraction for CIED infection after LVAD implantation at Duke University Hospital. Results Overall, 27 patients (n = 6 HVAD; n = 15 HeartMate II; n = 6 Heartmate III) underwent lead extraction for infection. Median (interquartile range) time from LVAD implantation to infection was 6.1 (2.5, 14.9) months. Indications included endocarditis (n = 16), bacteremia (n = 9), and pocket infection (n = 2). Common pathogens were Staphylococcus aureus (n = 10), coagulase-negative staphylococci (n = 7), and Enterococcus faecalis (n = 3). Sixty-eight leads were removed, with a median lead implant time of 5.7 (3.6, 9.2) years. Laser sheaths were used in all procedures, with a median laser time of 35.0 (17.5, 85.5) s. Mechanical cutting tools were required in 11 (40.7%) and femoral snaring in 4 (14.8%). Complete procedural success was achieved in 25 (93.6%) patients and clinical success in 27 (100%). No procedural failures or major adverse events occurred. Twenty-one patients (77.8%) were alive without persistent endovascular infection 1 year after lead extraction. Most were treated with oral suppressive antibiotics after extraction (n = 23 [82.5%]). Persistent infection after extraction occurred in 4 patients and was associated with 50% 1-year mortality. Conclusions Transvenous lead extraction for LVAD-associated CIED infection can be performed safely with low rates of persistent infection and 1-year mortality.
- Published
- 2020
40. Association between primary graft dysfunction and acute kidney injury after orthotopic heart transplantation – a retrospective, observational cohort study
- Author
-
Jacob N. Schroder, Jeffrey Lyvers, Mark Stafford-Smith, Carmelo A. Milano, Alina Nicoara, Madhav Swaminathan, Mary Cooter, Mihai V. Podgoreanu, Adam Kretzer, Chetan B. Patel, Raquel R. Bartz, and Sharon L. McCartney
- Subjects
Adult ,medicine.medical_specialty ,medicine.medical_treatment ,Primary Graft Dysfunction ,030230 surgery ,urologic and male genital diseases ,Cohort Studies ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Risk Factors ,Internal medicine ,Humans ,Medicine ,Risk factor ,Stage (cooking) ,Retrospective Studies ,Heart transplantation ,Transplantation ,Creatinine ,urogenital system ,business.industry ,Incidence ,Incidence (epidemiology) ,Acute kidney injury ,Acute Kidney Injury ,medicine.disease ,female genital diseases and pregnancy complications ,chemistry ,Heart Transplantation ,030211 gastroenterology & hepatology ,business ,Cohort study - Abstract
Acute kidney injury (AKI) and primary graft dysfunction (PGD) are serious complications after heart transplantation (HT). The relationship between AKI and PGD is poorly understood. We sought to examine the incidence of AKI and identify risk factors associated with AKI. We hypothesized that PGD is one of the risk factors independently associated with post-HT AKI. We gathered data for all adult patients who underwent HT between 2009 and 2014. AKI was defined by the KDIGO criteria. PGD was categorized using ISHLT criteria. We assessed univariable and multivariable logistic regression to identify risk factors independently associated with post-HT AKI. Out of 316 patients, postoperative AKI occurred in 273 (86%) patients: 188 (68%) stage I, 44 (16%) stage II, and 41 (15%) stage III. Stage II/III AKI was associated with increased risk of mortality at 1 year. There was significant association between severe PGD and stage II/III AKI (P = 0.001, OR 3.63, 95% CI: 1.69-7.94). Other clinical factors significantly associated with stage II/III AKI included longer donor brain death duration and lower recipient baseline creatinine. We found that stage II/III AKI is common and independently associated with severe PGD. Another potentially modifiable risk factor is donor brain death duration.
- Published
- 2020
41. Implantable cardioverter‐defibrillator lead revision following left ventricular assist device implantation
- Author
-
Carmelo A. Milano, Michael Rehorn, Sean D. Pokorney, Jonathan P. Piccini, Daniel J. Friedman, Kevin P. Jackson, Jacob N. Schroder, Eric Black-Maier, Camille Frazier-Mills, Brett D. Atwater, Robert K. Lewis, and Rahul S. Loungani
- Subjects
Adult ,Male ,Reoperation ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Electric Countershock ,030204 cardiovascular system & hematology ,Prosthesis Design ,Ventricular tachycardia ,Risk Assessment ,Ventricular Function, Left ,Prosthesis Implantation ,03 medical and health sciences ,0302 clinical medicine ,Risk Factors ,Interquartile range ,Physiology (medical) ,Internal medicine ,medicine ,Humans ,030212 general & internal medicine ,Lead (electronics) ,Aged ,Retrospective Studies ,Aged, 80 and over ,Heart Failure ,Fibrillation ,business.industry ,Arrhythmias, Cardiac ,Middle Aged ,medicine.disease ,Implantable cardioverter-defibrillator ,Defibrillators, Implantable ,Prosthesis Failure ,Death, Sudden, Cardiac ,Treatment Outcome ,Ventricular assist device ,Antitachycardia Pacing ,Cardiology ,Female ,Heart-Assist Devices ,Implant ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business - Abstract
Introduction Lead dysfunction can lead to serious consequences including failure to treat ventricular tachycardia or fibrillation (VT/VF). The incidence and mechanisms of lead dysfunction following left ventricular assist device (LVAD) implantation are not well-described. We sought to determine the incidence, mechanisms, timing, and complications of right ventricular lead dysfunction requiring revision following LVAD implantation. Methods Retrospective observational chart review of all LVAD recipients with pre-existing implantable cardioverter-defibrillator (ICD) from 2009 to 2018 was performed including device interrogation reports, laboratory and imaging data, procedural reports, and clinical outcomes. Results Among 583 patients with an ICD in situ undergoing LVAD implant, the median (interquartile range) age was 62.5 (15.7) years, 21% were female, and the types of LVADs included HeartWare HVAD (26%), HeartMate II (52%), and HeartMate III (22%). Right ventricular lead revision was performed in 38 patients (6.5%) at a median (25th, 75th) of 16.4 (3.6, 29.2) months following LVAD. Mechanisms of lead dysfunction included macrodislodgement (n = 4), surgical lead injury (n = 4), recall (n = 3), insulation failure (n = 8) or conductor fracture (n = 7), and alterations in the lead-myocardial interface (n = 12). Undersensing requiring revision occurred in 22 (58%) cases. Clinical sequelae of undersensing included failure to detect VT/VF (n = 4) and pacing-induced torsade de pointes (n = 1). Oversensing occurred in 12 (32%) and sequelae included inappropriate antitachycardia pacing ([ATP], n = 8), inappropriate ICD shock (n = 6), and ATP-induced VT (n = 1). Conclusion The incidence of right ventricular lead dysfunction following LVAD implantation is significant and has important clinical sequelae. Physicians should remain vigilant for lead dysfunction after LVAD surgery and test lead function before discharge.
- Published
- 2020
42. American Association for Thoracic Surgery/International Society for Heart and Lung Transplantation guidelines on selected topics in mechanical circulatory support
- Author
-
James K. Kirklin, Francis D. Pagani, Daniel J. Goldstein, Ranjit John, Joseph G. Rogers, Pavan Atluri, Francisco A. Arabia, Anson Cheung, William Holman, Charles Hoopes, Valuvan Jeevanandam, Ulrich P. Jorde, Carmelo A. Milano, Nader Moazami, Yoshifumi Naka, Ivan Netuka, Salpy V. Pamboukian, Sean Pinney, Craig H. Selzman, Scott Silverstry, Mark Slaughter, John Stulak, Jeff Teuteberg, Juliane Vierecke, Stephan Schueler, and David A. D'Alessandro
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Consensus ,Time Factors ,Waiting Lists ,medicine.medical_treatment ,Clinical Decision-Making ,Cardiology ,MEDLINE ,Prosthesis Design ,Risk Assessment ,Ventricular Function, Left ,Prosthesis Implantation ,Risk Factors ,medicine ,Humans ,Lung transplantation ,Societies, Medical ,Heart Failure ,Transplantation ,Evidence-Based Medicine ,business.industry ,Patient Selection ,General surgery ,Thoracic Surgery ,Recovery of Function ,Treatment Outcome ,Cardiothoracic surgery ,Practice Guidelines as Topic ,Circulatory system ,Heart Transplantation ,Surgery ,Heart-Assist Devices ,Cardiology and Cardiovascular Medicine ,business ,Lung Transplantation - Published
- 2020
43. LVAD Outflow Graft Role in Pump Thrombosis
- Author
-
Adam Nevo, Mani A. Daneshmand, Carmelo A. Milano, Jacob N. Schroder, and Yaron D. Barac
- Subjects
Male ,medicine.medical_specialty ,Biomedical Engineering ,Biophysics ,Bioengineering ,030204 cardiovascular system & hematology ,Biomaterials ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,In patient ,Pump thrombosis ,Heart Failure ,business.industry ,Treatment options ,Thrombosis ,General Medicine ,Middle Aged ,equipment and supplies ,medicine.disease ,030228 respiratory system ,Heart failure ,Circulatory system ,Cardiology ,Outflow ,Heart-Assist Devices ,Complication ,business - Abstract
Left ventricular assist devices are (LVAD) used for circulatory support in patients with end-stage heart failure. Hemolysis/pump dysfunction is a well-known complication of this therapy with various etiologic causes. A small proportion of these complications are caused by outflow graft obstructions; this complication has received little attention in the scientific literature. Herein, we provide a comprehensive overview of the role of the LVAD outflow graft obstruction and its treatment options.
- Published
- 2020
44. Treatment of Perioperative Ischemia, Infarction, and Ventricular Failure in Cardiac Surgery
- Author
-
Muath Bishawi and Carmelo A. Milano
- Subjects
Ventricular failure ,medicine.medical_specialty ,business.industry ,Internal medicine ,Ischemia ,Cardiology ,Medicine ,Infarction ,Perioperative ,business ,medicine.disease ,Cardiac surgery - Published
- 2022
45. Contributors
- Author
-
Vatche G. Agopian, Ehab Al-Bizri, Benjamin Y. Andrew, Thomas L. Archer, Gareth L. Ackland, John G. Augoustides, Diana Ayubcha, Angela Bader, Shyamasundar Balasubramanya, Peyman Benharash, Miles Berger, Muath Bishawi, Victoria Bradford, Thomas Buchheit, Christopher R. Burke, Maurizio Cereda, Anne Cherry, Albert T. Cheung, Kathleen Claus, Benedict Charles Creagh-Brown, Jovany Cruz Navarro, James DeBritz, null Timothy J. Donahue, Stephen A. Esper, Amanda L. Faulkner, Duane J. Funk, Robert Gaiser, Tong J. Gan, Stephen Harrison Gregory, Michael P.W. Grocott, Taras Grosh, Holden K. Groves, Dhanesh K. Gupta, Rachel A. Hadler, Steven Ellis Hill, Michael Holmes, Q. Lina Hu, Peter Inglis, Andrew Iskander, Alexander I.R. Jackson, Amir K. Jaffer, Michael L. James, Timothy F. Jones, Tammy Ju, Lillian S. Kao, John A. Kellum, Miklos D. Kertai, Clifford Y. Ko, W. Andrew Kofke, H.T. Lee, Jane Lee, Jason B. Liu, Jessica Y. Liu, Alex Macario, G. Burkhard Mackensen, Erin Maddy, Aman Mahajan, Joseph P. Mathew, Megan Maxwell, David L. McDonagh, Meghan Michael, Carmelo A. Milano, Richard C. Month, Eugene W. Moretti, Rotem Naftalovich, Mark F. Newman, Daisuke Francis Nonaka, Prakash A. Patel, Jamie R. Privratsky, Vijay K. Ramaiah, Neil Ray, Annette Rebel, Lisbi Rivas, Kristen C. Rock, Jill S. Sage, Yas Sanaiha, Babak Sarani, Ryan D. Scully, Jyotirmay Sharma, Robert A. Sickeler, Martin I. Sigurdsson, Mervyn Singer, Pingping Song, Audrey E. Spelde, Mark Stafford-Smith, Kirsten R. Steffner, Toby B. Steinberg, Dr. Charlotte Summers, Ramesh Swamiappan, Annemarie Thompson, Rachel E. Thompson, Thomas K. Varghese, Edward D. Verrier, Nathan H. Waldron, Sophie Louisa May Walker, and Ian J. Welsby
- Published
- 2022
46. Design and Rationale of a Phase 2 Study of NeurOtoxin (Botulinum Toxin Type A) for the PreVention of Post-Operative Atrial Fibrillation - The NOVA Study
- Author
-
Mitchell F. Brin, Jonathan S. Steinberg, Anders Ahlsson, Nathan H. Waldron, Louis P. Perrault, Paul Dorian, Michael J. Mack, Lawrence M. Adams, William G. Ferguson, Stefano Benussi, David B. Bharucha, Jonathan P. Piccini, Peter R. Kowey, Marc Gillinov, and Carmelo A. Milano
- Subjects
Tachycardia ,medicine.medical_specialty ,Time Factors ,Botulinum Toxins ,Neurotoxins ,Placebo ,law.invention ,Type A ,Postoperative Complications ,law ,Atrial Fibrillation ,Clinical endpoint ,medicine ,Humans ,Botulinum Toxins, Type A ,Cardiac Surgical Procedures ,business.industry ,Atrial fibrillation ,medicine.disease ,Botulinum toxin ,Intensive care unit ,Cardiac surgery ,Anesthesia ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,Complication ,medicine.drug - Abstract
Background : Post-operative AF (POAF) is the most common complication following cardiac surgery, occurring in 30% to 60% of patients undergoing bypass and/or valve surgery. POAF is associated with longer intensive care unit/hospital stays, increased healthcare utilization, and increased morbidity and mortality. Injection of botulinum toxin type A into the epicardial fat pads resulted in reduction of AF in animal models, and in 2 clinical studies of cardiac surgery patients, without new safety observations. Methods : The objective of NOVA is to assess the use of AGN-151607 (botulinum toxin type A) for prevention of POAF in cardiac surgery patients. This randomized, multi-site, placebo-controlled trial will study one-time injections of AGN-151607 125 U (25 U / fat pad) and 250 U (50 U / fat pad) or placebo during cardiac surgery in ∼330 participants. Primary endpoint: % of patients with continuous AF ≥ 30 s. Secondary endpoints include several measures of AF frequency, duration, and burden. Additional endpoints include clinically important tachycardia during AF, time to AF termination, and healthcare utilization. Primary and secondary efficacy endpoints will be assessed using continuous ECG monitoring for 30 days following surgery. All patients will be followed for up to 1 year for safety. Conclusion : The NOVA Study will test the hypothesis that injections of AGN-151607 will reduce the incidence of POAF and associated resource utilization. If demonstrated to be safe and effective, the availability of a one-time therapy for the prevention of POAF would represent an important treatment option for patients undergoing cardiac surgery.
- Published
- 2022
47. Stroke risk following implantation of current generation centrifugal flow left ventricular assist devices
- Author
-
Adam D. DeVore, Chetan B. Patel, Jacob N. Schroder, Mani A. Daneshmand, Daniel N. Cox, Carmelo A. Milano, Yuting P. Chiang, Muath Bishawi, and Laura J. Blue
- Subjects
Adult ,Male ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Prosthesis Implantation ,Young Adult ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Risk Factors ,Median follow-up ,Internal medicine ,medicine ,Humans ,Stroke ,Retrospective Studies ,Univariate analysis ,business.industry ,Hazard ratio ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Confidence interval ,030228 respiratory system ,Ventricular assist device ,Heart failure ,Cardiology ,Female ,Surgery ,Heart-Assist Devices ,Cardiology and Cardiovascular Medicine ,business - Abstract
Stroke remains a significant complication of left ventricular assist device (LVAD) therapy. We performed a single-center retrospective study evaluating patients undergoing first-time HeartWare HVAD (Medtronic Inc) or HeartMate 3 (Abbott Inc) implantation from September 2009-February 2018.Exclusion criteria were age18 and preoperative ECMO. The primary endpoint was stroke-free survival. Stroke was defined as new neurological deficits persisting24 hours with corresponding radiographic evidence. Risk factors evaluated included demographics, medical comorbidities, heart failure etiology, LVAD indication, INTERMACS profile, and device type. Univariate predictors (P .15) and variables clinically suspected to raise stroke risk were entered in a multivariate hazard regression model, specified using backward selection of covariates and accounting for competing risks of transplant/LVAD exchange.A total of 163 HVAD and 84 HM3 patients were analyzed. Median follow up (until death, censoring for transplant/LVAD removal, or end of follow up) was 1.2 years in HVAD patients and 1.4 years in HM3 patients. Stroke occurred in 24 HVAD patients (15 ischemic, 9 hemorrhagic) and 6 HM3 patients (4 ischemic, 2 hemorrhagic). One-year stroke-free survival was 76.8% for HVAD and 84.3% for HM3. Thirty-day mortality following stroke was 41.7% for HVAD and 66.7% for HM3; 54.2% of HVAD strokes were disabling compared to 83.3% of HM3 strokes. Age, LVAD indication, and device type were associated (P .15) with stroke on univariate analysis. On multivariate analysis, the HVAD was associated with significantly higher stroke risk (hazard ratio, 2.57; 95% confidence interval, 1.02-6.44; P = .045).Different LVAD models appear to be associated with significantly different stroke risks.
- Published
- 2019
48. A Case of Rare Inherited Restrictive Cardiomyopathy With Severe Biatrial Enlargement
- Author
-
Marat Fudim, Adam D. DeVore, Navid A. Nafissi, Richa Agarwal, Paul B. Rosenberg, and Carmelo A. Milano
- Subjects
medicine.medical_specialty ,AF, atrial fibrillation ,HCM, hypertrophic cardiomyopathy ,RCM, restrictive cardiomyopathy ,Cardiomyopathy ,Case Report ,HCM - Hypertrophic cardiomyopathy ,Clinical Case ,BVA, blood volume analysis ,Internal medicine ,medicine ,Diseases of the circulatory (Cardiovascular) system ,genetic disorders ,restrictive ,LV, left ventricular ,AF - Atrial fibrillation ,business.industry ,Restrictive cardiomyopathy ,imaging ,medicine.disease ,RC666-701 ,Etiology ,Cardiology ,Cardiology and Cardiovascular Medicine ,business ,cardiac transplant ,cardiomyopathy - Abstract
We describe a case of inherited restrictive cardiomyopathy in a patient presenting with severe biatrial enlargement. We review the evaluation and management of restrictive cardiomyopathy with a focus on genetic etiologies. (Level of Difficulty: Intermediate.), Graphical abstract, We describe a case of inherited restrictive cardiomyopathy in a patient presenting with severe biatrial enlargement. We review the evaluation and…
- Published
- 2019
49. Right and left ventricular assist devices are an option for bridge to heart transplant
- Author
-
Yaron D. Barac, Ronen Toledano, Oliver K. Jawitz, Jacob N. Schroder, Mani A. Daneshmand, Chetan B. Patel, Dan Aravot, and Carmelo A. Milano
- Subjects
Pulmonary and Respiratory Medicine ,Surgery ,Cardiology and Cardiovascular Medicine - Abstract
Patients with a left ventricular assist device with right ventricular failure are prioritized on the heart transplant waitlist; however, their post-transplant survival is less well characterized. We aimed to determine whether pretransplant right ventricular failure affects postoperative survival in patients with a left ventricular assist device as a bridge to transplant.We performed a retrospective review of the 2005-2018 Organ Procurement and Transplantation Network/United Network for Organ Sharing registry for candidates aged 18 years or more waitlisted for first-time isolated heart transplantation after left ventricular assist device implantation. Candidates were stratified on the basis of having right ventricular failure, defined as the need for right ventricular assist device or intravenous inotropes. Baseline demographic and clinical characteristics were compared among the 3 groups, and post-transplant survival was assessed.Our cohort included 5605 candidates who met inclusion criteria, including 450 patients with right ventricular failure, 344 patients with a left ventricular assist device and intravenous inotropes as a bridge to transplant, 106 patients with a left ventricular assist device and right ventricular assist device, and 5155 patients with a left ventricular assist device as a bridge to transplant without the need for right side support. Compared with patients without right ventricular failure, patients with a left ventricular assist device as a bridge to transplant with right ventricular failure were younger (median age 51 years, 55 vs 56 years,Patients with biventricular failure are prioritized on the waiting list, because their critical pretransplant condition has limited impact on their post-transplant survival (short-term effect only); thus, surgeons should be confident to perform transplantation in these severely ill patients. Because liver dysfunction (a surrogate marker of right ventricular failure) was found to affect long-term survival in patients with a left ventricular assist device, surgeons should be encouraged to perform transplantation in these severely ill patients after a recipient's optimization by inotropes or a right ventricular assist device because even when the bilirubin level is elevated in these patients (treated with right ventricular assist device/inotropes), their long-term survival is not affected. Future studies should assess recipients' optimization before organ acceptance to improve long-term survival.
- Published
- 2021
50. CARMAT Total Artificial Heart and the Quest to Improve Biventricular Mechanical Support
- Author
-
Carmelo A. Milano and Jacob N. Schroder
- Subjects
medicine.medical_specialty ,pulsatile ,business.industry ,physiologic ,autoregulation ,Biomedical Engineering ,Biophysics ,Bioengineering ,Heart, Artificial ,General Medicine ,hemodynamics ,total artificial heart ,law.invention ,bioprosthetic ,Biomaterials ,law ,Adult Circulatory Support ,Internal medicine ,Artificial heart ,medicine ,Cardiology ,Heart Transplantation ,business - Abstract
The CARMAT-Total Artificial Heart (C-TAH) is designed to provide heart replacement therapy for patients with end-stage biventricular failure. This report details the reliability and efficacy of the autoregulation device control mechanism (auto-mode), designed to mimic normal physiologic responses to changing patient needs. Hemodynamic data from a continuous cohort of 10 patients implanted with the device, recorded over 1,842 support days in auto-mode, were analyzed with respect to daily changing physiologic needs. The C-TAH uses embedded pressure sensors to regulate the pump output. Right and left ventricular outputs are automatically balanced. The operator sets target values and the inbuilt algorithm adjusts the stroke volume and beat rate, and hence cardiac output, automatically. Auto-mode is set perioperatively after initial postcardiopulmonary bypass hemodynamic stabilization. All patients showed a range of average inflow pressures of between 5 and 20 mm Hg during their daily activities, resulting in cardiac output responses of between 4.3 and 7.3 L/min. Operator adjustments were cumulatively only required on 20 occasions. This report demonstrates that the C-TAH auto-mode effectively produces appropriate physiologic responses reflective of changing patients’ daily needs and represents one of the unique characteristics of this device in providing almost physiologic heart replacement therapy.
- Published
- 2021
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.