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TCT CONNECT-342 Outcomes of MitraClip Repair in Primary Mitral Regurgitation Patients With STS Repair Score of Less Than 6% and STS Replacement Score of Less Than 8%: Results From the Global EXPAND Study [Meeting Abstract]

Tang, G; Williams, M; Rinaldi, M; Denti, P; Kini, A; Lerakis, S; Morse, A; Rodriguez, E; Maisano, F; Kar, S
Background: Transcatheter mitral valve repair with the MitraClip system has been shown to be safe and effective for the treatment of significant primary mitral regurgitation (MR) in patients deemed prohibitive risk for surgery. This analysis evaluated the outcomes of MitraClip repair in primary MR subjects with STS PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) score <6% for surgical repair and <8% for replacement from the global EXPAND (A Contemporary, Prospective Study Evaluating Real-World Experience of Performance and Safety for the Next Generation of MitraClip Devices) study.
Method(s): EXPAND is a prospective, multicenter, international, single-arm study that enrolled subjects at 57 centers in Europe and the United States. All echocardiograms were analyzed by an independent echo core laboratory, and major adverse events were adjudicated by an independent clinical events committee. Study outcomes included MR severity, procedural outcomes, major adverse events, New York Heart Association functional class and KCCQ (Kansas City Cardiomyopathy Questionnaire) score.
Result(s): Four hundred and twenty subjects with primary MR had adequate baseline echocardiographic imaging for assessment by the echo core laboratory. Of the 420 subjects, at least 166 patients either had an STS repair score <6% and an STS replacement score <8%. Average age was 77.2 +/- 10.4 years old, and 54% of the subjects were men. STS PROM score for surgical repair was 2.9 +/- 1.3% and replacement was 4.6 +/- 1.8%. Echo core laboratory-adjudicated acute procedural success, defined as survival to discharge with a successful implant resulting in reduction to MR severity <=2+, was achieved in 93.4% of the subjects. Clinical events committee-adjudicated all-cause mortality rate at 30 days was 1.2% (n = 2), and major adverse events rate was 4.2% (n = 7). MR reduction to <=2+ and MR <=1+ were achieved in 98% and 89% of subjects at 30 days, respectively. The reduction in MR severity was also associated with a significant reduction in left ventricle end-diastolic dimension (52.9 +/- 6.8 mm to 49.9 +/- 7.2 mm; n = 144; p < 0.0001) and volume (126.1 +/- 50.5 ml to 114.5 +/- 44.9 ml; n = 138; p < 0.0001). There were also improvements in functional capacity (69% New York Heart Association functional class III/IV at baseline vs. 18% at 30 days; p < 0.0001) and quality of life (mean change in KCCQ score from baseline to 30 days: +18.7 +/- 24.0; p < 0.0001). Univariate analysis of MR reduction (2 grades or more) were baseline MR severity (p < 0.0001), peak E velocity (p < 0.037), mean mitral gradient (p < 0.026), presence of ruptured chordae (p < 0.001), leaflet flail (p < 0.0002), leaflet billowing (p < 0.0001), and prolapse or flail gap (p < 0.037).
Conclusion(s): In patients with primary MR and an STS repair risk score <6% and replacement score <8%, the MitraClip NTR and XTR system was found to be safe and effective at reducing MR and improving left ventricular remodeling and was associated with significant improvements in quality of life and functional capacity. Categories: STRUCTURAL: Valvular Disease: Mitral
Copyright
EMBASE:2008355533
ISSN: 1558-3597
CID: 4659302

Equity in access to facial transplantation

Kimberly, Laura L; Ramly, Elie P; Alfonso, Allyson R; Diep, Gustave K; Berman, Zoe P; Rodriguez, Eduardo D
We examine ethical considerations in access to facial transplantation (FT), with implications for promoting health equity. As a form of vascularised composite allotransplantation, FT is still considered innovative with a relatively low volume of procedures performed to date by a small number of active FT programmes worldwide. However, as numbers continue to increase and institutions look to establish new FT programmes, we anticipate that attention will shift from feasibility towards ensuring the benefits of FT are equitably available to those in need. This manuscript assesses barriers to care and their ethical implications across a number of considerations, with the intent of mapping various factors relating to health equity and fair access to FT. Evidence is drawn from an evolving clinical experience as well as published scholarship addressing several dimensions of access to FT. We also explore novel concerns that have yet to be mentioned in the literature.
PMID: 33060187
ISSN: 1473-4257
CID: 4651882

Guiding Strategies for the Future of Vascularized Composite Allotransplantation: A Systematic Review of Organ Donation Campaigns

Mills, Emily; Felsenheld, Julia H; Berman, Zoe P; Alfonso, Allyson R; Diep, Gustave K; Wolfe, Erin M; Park, Jenn J; Hoffman, Alexandra F; Ramly, Elie P; Rodriguez, Eduardo D
BACKGROUND:Since the 1990s, the field of vascularized composite allotransplantation has gained momentum, offering unprecedented solutions for patients with defects not amenable to autologous reconstruction. As with solid organ donation, the vascularized composite allotransplant donor pool remains limited. This systematic review identifies past successes and failures in organ donation campaigns to guide future strategies for expanding vascularized composite allotransplant donation. METHODS:A systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Three databases (PubMed/MEDLINE, PsycINFO, and Embase) were searched through July 31, 2019. The study compiled solid organ and vascularized composite allotransplant campaigns that aimed to increase donor registration. Articles depicting the current state of vascularized composite allotransplant donation were also assessed. RESULTS:Of an initial 3318 articles identified, 40 were included. Six articles described direct mail or print interventions, 10 depicted Web-based interventions, 13 dealt with interpersonal interventions, and seven used multimodal interventions. Four articles described the current state of vascularized composite allotransplant donation. A qualitative synthesis was conducted. The authors found that social media campaigns can have a robust but fleeting effect on registration trends and that interpersonal interventions are effective at increasing registration rates. In addition, the opportunity for participants to immediately register as organ donors, by means of either return mail, in-person, or online, is vital to campaign success. CONCLUSIONS:Public organ donation campaigns have had success in increasing organ donor registration rates, particularly through the use of social media and interpersonal interventions that allow for immediate registration. Synthesizing this information, we propose a multimodal campaign to expand the vascularized composite allotransplant donor pool.
PMID: 32970015
ISSN: 1529-4242
CID: 4624632

A Comparison of Immunosuppression Regimens in Hand, Face, and Kidney Transplantation

Rifkin, William J; Manjunath, Amit K; Kantar, Rami S; Jacoby, Adam; Kimberly, Laura L; Gelb, Bruce E; Diaz-Siso, J Rodrigo; Rodriguez, Eduardo D
BACKGROUND:Authors have speculated that vascularized composite allotransplantation (VCA) recipients may require greater maintenance immunosuppression than solid organ transplant (SOT) recipients due to the higher antigenicity of skin. However, detailed comparisons of VCA and SOT immunosuppression regimens have been limited. METHODS:Hand and face VCA recipient immunosuppression data were collected through a systematic literature review. Kidney recipient data were obtained through a retrospective chart review of the authors' institution. Prednisone and mycophenolate mofetil (MMF) doses were compared between VCA and kidney recipients at predefined follow-up intervals (<1, 1-5, and >5 y). Tacrolimus target trough levels (TTTL) were compared at follow-up intervals of 1-5 and >5 y, and stratified into our institution's kidney transplant risk-based target ranges (4-6 ng/mL, 6-8 ng/mL) or higher (>8 ng/mL). RESULTS:Immunosuppression data were available for 57 VCA and 98 kidney recipients. There were no significant differences in prednisone doses between groups at all follow-up intervals. VCA recipient mean MMF dose was significantly greater at <1-y (1.71 ± 0.58 versus 1.16 ± 0.55 gm/d; P = 0.01). For VCA recipients, there was a significant difference (P = 0.02) in TTTL distribution over the three predefined therapeutic ranges (4-6 ng/mL, 6-8 ng/mL, and >8 ng/mL) between 1 and 5 y (24.0%, 20.0%, 56.0%, respectively) and >5 y (28.6%, 42.9%, 28.6%). CONCLUSIONS:At longer follow-up, VCA and kidney recipients receive comparable MMF/prednisone doses, and most VCA recipients are treated with TTTL similar to kidney recipients. Further research may improve our understanding of VCA's complex risk/benefit ratio, and enhance informed consent.
PMID: 32977237
ISSN: 1095-8673
CID: 4609112

Development of Donor Family-Oriented Resources to Facilitate Authorization for Reconstructive Transplantation

Berman, Zoe P; Alfonso, Allyson R; Diep, Gustave K; Ramly, Elie P; Wolfe, Erin M; Raheem, Safiya; Irving, Helen; Rodriguez, Eduardo D
PMID: 32912042
ISSN: 2164-6708
CID: 4596432

Technical Pearls in Frontal and Periorbital Bone Contouring in Gender-Affirmation Surgery

Eisemann, Bradley S; Wilson, Stelios C; Ramly, Elie P; Kantar, Rami S; Alfonso, Allyson R; Frey, Jordan D; Bluebond-Langer, Rachel; Rodriguez, Eduardo D
Changes made to the forehead and periorbital region can have dramatic effects in gender-affirmation surgery. Removal of frontal bossing and alteration of orbital shape can result in significant facial feminization. This elective surgical intervention must be safe, reliable, and aesthetically effective. The described technique of frontal and periorbital bone contouring allows for a safe and consistent surgical outcome in properly selected patients. Nuances in specific technical maneuvers in this operation can have profound effects on safety and aesthetic outcomes. In this article, specific points are detailed in text and video describing the senior author's (E.D.R) surgical approach.
PMID: 32842114
ISSN: 1529-4242
CID: 4586872

Vascularized Composite Allotransplantation in a Post-COVID-19 Pandemic World

Ramly, Elie P; Berman, Zoe P; Diep, Gustave K; Alfonso, Allyson R; Kimberly, Laura L; Rodriguez, Eduardo D
PMID: 32541532
ISSN: 1529-4242
CID: 4514742

Vascularized Composite Allotransplantation 2.0: The Future Is Now

Ramly, Elie P; Berman, Zoe P; Diep, Gustave K; Alfonso, Allyson R; Kimberly, Laura L; Gelb, Bruce E; Rodriguez, Eduardo D
PMID: 32842130
ISSN: 1529-4242
CID: 4614452

A case of facial composite tissue allograft rejection [Case Report]

Yan, Di; Stokar, Evan; Jacoby, Adam; Gelb, Bruce E; Rodriguez, Eduardo D; Meehan, Shane A
PMCID:7452299
PMID: 32875035
ISSN: 2352-5126
CID: 4615392

Communication Efficiency in a Face Transplant Recipient: Determinants and Therapeutic Implications

Levy-Lambert, Dina; Grigos, Maria I; LeBlanc, Étoile; DeMitchell-Rodriguez, Evellyn M; Noel, Daphney Y; Alfonso, Allyson R; Ramly, Elie P; Rifkin, William J; Diaz-Siso, J Rodrigo; Ceradini, Daniel J; Kantar, Rami S; Rodriguez, Eduardo D
We longitudinally assessed speech intelligibility (percent words correct/pwc), communication efficiency (intelligible words per minute/iwpm), temporal control markers (speech and pause coefficients of variation), and formant frequencies associated with lip motion in a 41-year-old face transplant recipient. Pwc and iwpm at 13 months post-transplantation were both higher than preoperative values. Multivariate regression demonstrated that temporal markers and all formant frequencies associated with lip motion were significant predictors (P < 0.05) of communication efficiency, highlighting the interplay of these variables in generating intelligible and effective speech. These findings can guide us in developing personalized rehabilitative approaches in face transplant recipients for optimal speech outcomes.
PMID: 32649536
ISSN: 1536-3732
CID: 4517332