22 results on '"Hensey, Mark"'
Search Results
2. Multimodality Imaging to Assess Leaflet Height in Mitral Bioprosthetic Valves: Implications for Mitral Valve-in-Valve Procedure.
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Akodad M, Sathananthan J, Tzimas G, Salcudean H, Hensey M, Gulsin GS, Meier D, Anthony Chuang MY, Chatfield AG, Landes U, Blanke P, Sondergaard L, Payne GW, Lutter G, Puehler T, Wood DA, Webb JG, Leipsic JA, and Sellers SL
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- Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Predictive Value of Tests, Bioprosthesis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation methods, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery
- Abstract
Competing Interests: Funding Support and Author Disclosures Funding was received from St Paul's Foundation and the Providence Health Care Research Institute (PHCRI) Early Career Research Initiative. Dr Akodad has received research funding from Medtronic, Biotronik, MUSE Explore, and Federation Française de Cardiologie. Dr Sathananthan has received speaker fees from Edwards Lifesciences and NVT Medical; and has reported consulting for Edwards Lifesciences, Boston Scientific, and Medtronic. Dr Tzimas has reported support from the Fondation Vaudoise de Cardiologie. Dr Gulsin has reported support from a British Heart Foundation Travel Fellowship (FS/TF/21/33008). Dr Blanke has reported consulting for Edwards Lifesciences, Boston Scientific, and Neovasc; and has provided computed tomography core laboratory services for Edwards Lifesciences, Medtronic, Neovasc, Boston Scientific, and Abbott, for which no direct compensation was received. Dr Sondergaard has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and SMT. Dr Wood has reported consulting for and has received research funding from Edwards Lifesciences and Abbott. Dr Webb has reported consulting for Edwards Lifesciences. Dr Leipsic has reported support from a Canadian Research Chair in Advanced Cardiopulmonary Imaging; has reported consulting for MVRX, HeartFlow, and Circle Cardiovascular Imaging; and has provided computed tomography core laboratory services for Edwards Lifesciences, Medtronic, Neovasc, Boston Scientific, and Abbott, for which no direct compensation is received. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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- 2022
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3. Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System: A Multicenter, Observational, First-in-Human Experience.
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Fam NP, von Bardeleben RS, Hensey M, Kodali SK, Smith RL, Hausleiter J, Ong G, Boone R, Ruf T, George I, Szerlip M, Näbauer M, Ali FM, Moss R, Bapat V, Schnitzler K, Kreidel F, Ye J, Deva DP, Mack MJ, Grayburn PA, Peterson MD, Leon MB, Hahn RT, and Webb JG
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- Aged, Cardiac Catheterization adverse effects, Female, Humans, Male, Time Factors, Treatment Outcome, Tricuspid Valve diagnostic imaging, Tricuspid Valve surgery, Heart Valve Prosthesis Implantation adverse effects, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency surgery
- Abstract
Objectives: The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the EVOQUE tricuspid valve replacement system and its impact on short-term clinical outcomes., Background: Transcatheter tricuspid intervention is a promising option for selected patients with severe tricuspid regurgitation (TR). Although transcatheter leaflet repair is an option for some, transcatheter tricuspid valve replacement (TTVR) may be applicable to a broader population., Methods: Twenty-five patients with severe TR underwent EVOQUE TTVR in a compassionate-use experience. The primary outcome was technical success, with NYHA (NYHA) functional class, TR grade, and major adverse cardiac and cerebrovascular events assessed at 30-day follow-up., Results: All patients (mean age 76 ± 3 years, 88% women) were at high surgical risk (mean Society of Thoracic Surgeons risk score 9.1 ± 2.3%), with 96% in NYHA functional class III or IV. TR etiology was predominantly functional, with mean tricuspid annular diameter of 44.8 ± 7.8 mm and mean tricuspid annular plane systolic excursion of 16 ± 2 mm. Technical success was 92%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 0%, 76% of patients were in NYHA functional class I or II, and TR grade was ≤2+ in 96%. Major bleeding occurred in 3 patients (12%), 2 patients (8%) required pacemaker implantation, and 1 patient (4%) required dialysis., Conclusions: This first-in-human experience evaluating EVOQUE TTVR demonstrated high technical success, acceptable safety, and significant clinical improvement. Larger prospective studies are needed to confirm durability and safety and the impact on long-term clinical outcomes., Competing Interests: Funding Support and Author Disclosures Dr. Fam has received speaker honoraria from Abbott Vascular; and is a consultant to Edwards Lifesciences. Dr. von Bardeleben received speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr. Ye is a consultant to Edwards Lifesciences, JC Medical, and CryoLife. Dr. Moss is a consultant to Edwards Lifesciences. Dr. Hausleiter has received speaker honoraria and research support from Abbott Vascular and Edwards Lifesciences; and is a consultant to Abbott Vascular and Edwards Lifesciences. Dr. George is consultant to VDyne, CardioMech, Atricure, MitreMedical, Neptune Medical, and W.L. Gore. Dr. Nabauer has received speaker honoraria from Abbott Vascular. Dr. Mack is co–principal investigator of the PARTNER (Placement of Aortic Transcatheter Valves) 3 trial for Edwards Lifesciences; is co–principal investigator of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial for Abbott; and is study chair of the APOLLO (Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation) trial for Medtronic (all uncompensated). Dr. Hahn has received speaker fees from Edwards Lifesciences; is a consultant for Abbott Vascular, Boston Scientific, Gore & Associates, and Medtronic; holds equity with Navigate; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr. Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Boston Scientific, Becton Dickinson, and ViVitro Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2021
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4. Transcatheter Mitral Valve Replacement: An Update on Current Techniques, Technologies, and Future Directions.
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Hensey M, Brown RA, Lal S, Sathananthan J, Ye J, Cheung A, Blanke P, Leipsic J, Moss R, Boone R, and Webb JG
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- Cardiac Catheterization adverse effects, Humans, Mitral Valve diagnostic imaging, Mitral Valve surgery, Treatment Outcome, Heart Valve Prosthesis Implantation adverse effects, Mitral Valve Annuloplasty adverse effects, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency surgery
- Abstract
Growing clinical data support the use of transcatheter therapies for significant mitral valve disease. Currently, edge-to-edge repair is the transcatheter treatment of choice, but many anatomies are not suitable. Transcatheter mitral valve replacement offers several potential advantages over transcatheter repair, most notably a greater and more sustained reduction in mitral regurgitation post-implantation, but also potential disadvantages. To enable the successful treatment of mitral valve disease in a wide range of patients and anatomies, we require an armory of transcatheter devices, including transcatheter mitral valve replacement systems., Competing Interests: Funding Support and Author Disclosures Dr. Sathananthan is a consultant to Edward Lifesciences and Medtronic. Dr. Ye is a consultant to Edwards Lifesciences. Dr. Cheung is a consultant to Abbott Vascular, Medtronic, and Neovasc. Dr. Webb is a consultant to Edwards Lifesciences, Abbott Vascular, and Boston Scientific. Dr. Blanke is a consultant to Edwards Lifesciences, Tendyne, Neovasc, Circle Cardiovascular Imaging, and Gore. Dr. Leipsic is a consultant to Edwards Lifesciences, Neovasc, Abbott, Medtronic, and GE Healthcare; and has been a consultant to and holds stock in Circle Cardiovascular Imaging and HeartFlow. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Crown Copyright © 2021. Published by Elsevier Inc. All rights reserved.)
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- 2021
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5. Tricuspid Valve-in-Valve and Bioprosthetic Surgical Tricuspid and Pulmonic Valve Degeneration: Lessons From Imaging and Histopathology.
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Sellers SL, Hensey M, Cartlidge TRG, Turner CT, Lau K, Lai A, Salcudean H, Sathananthan J, McManus BM, Granville DJ, Payne GW, Pibarot P, Webb JG, Newby DE, Blanke P, Seidman MA, Dweck MR, and Leipsic JA
- Subjects
- Humans, Predictive Value of Tests, Tricuspid Valve surgery, Bioprosthesis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Tricuspid Valve Insufficiency surgery
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- 2020
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6. Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System.
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Webb J, Hensey M, Fam N, Rodés-Cabau J, Daniels D, Smith R, Szeto W, Boone R, Ye J, Moss R, Peterson M, Ong G, Paradis JM, Dagenais F, Wintzer-Wehekind J, Shafi B, Nair D, Szerlip M, Grayburn P, Silvestry F, Koulogiannis K, Hermiller J, Guyton R, and Herrmann H
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- Aged, 80 and over, Humans, Treatment Outcome, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Mitral Valve surgery, Mitral Valve Insufficiency surgery
- Abstract
Objectives: The aim of this study was to examine the initial experience with a novel transseptal transcatheter mitral valve replacement (TMVR) system., Background: Transseptal TMVR may offer a less invasive option than surgery for mitral regurgitation (MR) with greater efficacy and fewer anatomic limitations than transcatheter repair., Methods: Patients were treated with the EVOQUE TMVR system from September 2018 to October 2019. Key inclusion criteria were moderate or greater MR, New York Heart Association functional class ≥II, and high or prohibitive surgical risk. The primary outcome was technical success, defined by Mitral Valve Academic Research Consortium criteria., Results: Fourteen patients were treated, all with at least moderate to severe MR. The median age was 84 years, and the median Society of Thoracic Surgeons score was 4.6%. MR was degenerative in 4 (28.6%), functional in 3 (21.4%), and mixed in 7 (50%). Technical success was achieved in 13 patients (92.9%), and 1 patient was converted to surgery. At 30 days there was 1 noncardiovascular mortality (7.1%), 2 strokes (14.3%), no myocardial infarctions, and no rehospitalizations. Two patients (14.3%) underwent paravalvular leak closure. One patient (7.1%) underwent alcohol septal ablation for left ventricular outflow tract obstruction. Including the 2 patients with paravalvular leak closure, MR was mild or less in all implanted patients at 30 days, with no MR in 10 (83.3%). Mean mitral gradient was 5.8 mm Hg (median). New York Heart Association functional class improved to ≤II in 9 patients (81.8%)., Conclusions: This first-in-human experience has demonstrated the feasibility of the transseptal EVOQUE TMVR system. Further clinical studies are required to establish safety and clinical outcomes., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2020
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7. 1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.
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Webb JG, Hensey M, Szerlip M, Schäfer U, Cohen GN, Kar S, Makkar R, Kipperman RM, Spargias K, O'Neill WW, Ng MKC, Fam NP, Rinaldi MJ, Smith RL, Walters DL, Raffel CO, Levisay J, Latib A, Montorfano M, Marcoff L, Shrivastava M, Boone R, Gilmore S, Feldman TE, and Lim DS
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- Aged, Humans, Mitral Valve surgery, Quality of Life, Treatment Outcome, Cardiac Surgical Procedures, Heart Valve Prosthesis Implantation, Mitral Valve Insufficiency surgery
- Abstract
Objectives: The authors report the CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) expanded experience, 1-year outcomes, and analysis by functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR)., Background: The 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported., Methods: Eligible patients had symptomatic MR ≥3+, were receiving optimal medical therapy, and were deemed candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days. Follow-up was continued to 1 year., Results: One hundred nine patients were treated (67% FMR, 33% DMR); the mean age was 75.5 years, and 57% were in New York Heart Association functional class III or IV. At 30 days, there was 1 cardiovascular death (0.9%), MR ≤1+ was achieved in 80% of patients (77% FMR, 86% DMR) and MR ≤2+ in 96% (96% FMR, 97% DMR), 88% of patients were in New York Heart Association functional class I or II, 6-min walk distance had improved by 28 m, and Kansas City Cardiomyopathy Questionnaire score had improved by 16 points (p < 0.001 for all). At 1 year, Kaplan-Meier survival was 92% (89% FMR 96% DMR) with 88% freedom from heart failure hospitalization (80% FMR, 100% DMR), MR was ≤1+ in 82% of patients (79% FMR, 86% DMR) and ≤2+ in 100% of patients, 88% of patients were in New York Heart Association functional class I or II, and Kansas City Cardiomyopathy Questionnaire score had improved by 14 points (p < 0.001 for all)., Conclusions: The PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival, with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at 1 year. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study [CLASP]; NCT03170349)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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8. Mitral regurgitation in patients undergoing transcatheter aortic valve implantation for degenerated surgical aortic bioprosthesis: Insights from PARTNER 2 Valve-in-Valve Registry.
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Murdoch DJ, Sathananthan J, Hensey M, Alu MC, Liu Y, Crowley A, Wood D, Cheung A, Ye J, Feldman T, Hahn RT, Jaber WA, Mack MJ, Malaisrie SC, Leon MB, and Webb JG
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- Aged, Aged, 80 and over, Aortic Valve diagnostic imaging, Aortic Valve physiopathology, Aortic Valve Insufficiency diagnostic imaging, Aortic Valve Insufficiency mortality, Aortic Valve Insufficiency physiopathology, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis mortality, Aortic Valve Stenosis physiopathology, Female, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation mortality, Humans, Male, Mitral Valve diagnostic imaging, Mitral Valve Insufficiency diagnostic imaging, Mitral Valve Insufficiency mortality, Recovery of Function, Registries, Risk Assessment, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, Aortic Valve surgery, Aortic Valve Insufficiency surgery, Aortic Valve Stenosis surgery, Bioprosthesis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation instrumentation, Mitral Valve physiopathology, Mitral Valve Insufficiency physiopathology, Prosthesis Failure, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement instrumentation, Transcatheter Aortic Valve Replacement mortality
- Abstract
Background: Valve-in-valve (VIV) treatment with transcatheter aortic valve replacement (TAVR) is a viable option for patients with failing aortic bioprosthetic valves. Optimal management of those with concomitant mitral regurgitation (MR) remains undetermined. Therefore, we sought to assess the implications of concomitant MR in patients undergoing VIV-TAVR., Methods and Results: The PARTNER 2 VIV registry enrolled patients with degenerated surgical aortic bioprosthesis at high risk for reoperation. Patients with core-laboratory echocardiographic assessment of MR were analyzed; severe MR was excluded. We compared patients with ≤mild MR versus moderate MR and assessed changes in MR severity and clinical outcomes. A total of 339 patients (89 initial registry, 250 continued access) underwent VIV procedures; mean age 79.0 ± 10.2 years, mean Society of Thoracic Surgeon score 8.9 ± 4.5%. At baseline, 228/339 (67.3%) had ≤mild MR and 111/339 (32.7%) had moderate MR. In paired analysis, there was significant improvement in ≥moderate MR from baseline to 30 days (32.6% vs. 14.5%, p < .0001 [n = 304]), and no significant change between 30 days and 1 year (13.4% vs. 12.1%, p = .56 [n = 224]) or 1 year and 2 years (11.0% vs. 10.4%, p = .81 [n = 182]). There was no difference in death or stroke between ≤mild MR and moderate MR at 30 days (4.0% vs. 7.2%, p = .20), 1 year (15.5% vs. 15.3%, p = .98) or 2 years (26.5% vs. 23.5%, p = .67)., Conclusion: Moderate concomitant MR tends to improve with VIV-TAVR, and was not a predictor of long-term adverse outcomes in this cohort. In selected patients undergoing VIV-TAVR, it may be appropriate to conservatively manage concomitant MR., Clinical Trial Registration: ClinicalTrials.gov NCT# 03225001., (© 2020 Wiley Periodicals, Inc.)
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- 2020
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9. Implications of hydrodynamic testing to guide sizing of self-expanding transcatheter heart valves for valve-in-valve procedures.
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Sathananthan J, Hensey M, Fraser R, Landes U, Blanke P, Hatoum H, Dasi LP, Sedaghat A, Bapat VN, Leipsic J, Søndergaard L, Wood DA, and Webb JG
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- Cardiac Catheterization adverse effects, Heart Valve Diseases physiopathology, Heart Valve Prosthesis Implantation adverse effects, Heart Valves physiopathology, Humans, Hydrodynamics, Materials Testing, Prosthesis Design, Time Factors, Transcatheter Aortic Valve Replacement adverse effects, Bioprosthesis, Cardiac Catheterization instrumentation, Heart Valve Diseases surgery, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation instrumentation, Heart Valves surgery, Transcatheter Aortic Valve Replacement instrumentation
- Abstract
Aims: The commonly used valve-in-valve (VIV) app recommends sizing based on dimensions of both the transcatheter heart valve (THV) and bioprosthetic surgical valve. The implications of hydrodynamic testing to guide VIV sizing are poorly understood. This bench study assessed the hydrodynamic performance of different sizes of self-expanding supra-annular THVs in three different surgical aortic bioprostheses at different implantation depths., Methods: A small versus medium ACURATE neo (ACn), and a 26 mm versus 29 mm Evolut R were assessed after VIV implantation in 25 mm Mitroflow, Mosaic, and Magna Ease aortic surgical bioprostheses, at three implantation depths (+2 mm, -2 mm, and -6 mm)., Results: The medium-sized ACn had lower gradients compared to the small ACn when the THV was implanted high (+2 mm, or -2 mm). The 29 mm Evolut R had lower gradients compared to a 26 mm Evolut R for all implantation depths, except for a depth of -2 mm in the 25 mm Mitroflow. The medium ACn and 29 mm Evolut R had larger effective orifice areas compared to the small ACn and 26 mm Evolut R, respectively. Both Evolut R sizes had acceptable regurgitant fractions (<15%), while both ACn sizes were above the acceptable performance criteria (>15%), at all implantation depths., Conclusions: Use of a larger self-expanding THV was associated with superior hydrodynamic performance if the THV was implanted high. Hydrodynamic testing can provide additional information to the VIV app to help guide VIV sizing., (© 2019 Wiley Periodicals, Inc.)
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- 2020
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10. Reference dimensions of stented surgical aortic bioprostheses for valve size determination.
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Anastasius M, Godoy M, Weir-McCall JR, Bapat V, Sathananthan J, Hensey M, Sellers SL, Cheung A, Ye J, Wood DA, Leipsic J, Webb J, and Blanke P
- Subjects
- Aortic Valve surgery, Prosthesis Design, Stents, Bioprosthesis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation adverse effects
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- 2020
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11. Bioprosthetic Valve Leaflet Displacement During Valve-in-Valve Intervention: An Ex Vivo Bench Study.
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Hensey M, Sellers S, Sathananthan J, Lai A, Landes U, Alkhodair A, McManus B, Cheung A, Wood D, Blanke P, Leipsic J, Ye J, and Webb J
- Subjects
- Coronary Stenosis etiology, Equipment Failure Analysis, Heart Valve Prosthesis Implantation adverse effects, Humans, Materials Testing, Prosthesis Design, Risk Assessment, Risk Factors, Transcatheter Aortic Valve Replacement adverse effects, Bioprosthesis, Coronary Stenosis prevention & control, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation instrumentation, Prosthesis Failure, Transcatheter Aortic Valve Replacement instrumentation
- Abstract
Objectives: The aim of this study was to examine the effect of different transcatheter heart valves (THVs) on valve leaflet displacement when deployed within bioprosthetic surgical valves and, thereby, risk for coronary obstruction., Background: Coronary obstruction is a potentially devastating complication during valve-in-valve (ViV) transcatheter aortic valve replacement. Strategies such as provisional stenting and intentional bioprosthetic valve leaflet laceration have been developed to mitigate this risk. Alternatively, the use of a THV that retracts the bioprosthetic leaflet away from the coronary ostium may prevent coronary obstruction., Methods: A 25-mm J-Valve, a 26-mm Evolut Pro, and a 23-mm JenaValve were implanted into both a 25-mm Trifecta surgical valve and a 25-mm Mitroflow surgical valve. A 23-mm and a 26-mm SAPIEN 3 were deployed into the Trifecta and Mitroflow, respectively. Displacement of the surgical valve leaflets (retraction vs. expansion) was measured with implantation of each THV by measuring displacement angle and maximal displacement distance., Results: Within both the Trifecta and Mitroflow valves, implantation of the J-Valve and JenaValve resulted in retraction of the surgical valve leaflets, and placement of the Evolut Pro and SAPIEN 3 resulted in tubular expansion of the surgical valve leaflets. There were significant differences in displacement angles and distances between both the J-Valve and JenaValve and the SAPIEN 3 and Evolut Pro (p < 0.0001)., Conclusions: ViV implantation with new-generation THVs that directly interact with bioprosthetic valve leaflets results in surgical valve leaflet retraction. This might mitigate the risk for coronary obstruction in selected cases of ViV transcatheter aortic valve replacement and also facilitate coronary reaccess after ViV TAVR., (Copyright © 2020 American College of Cardiology Foundation. All rights reserved.)
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- 2020
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12. Impact of implant depth on hydrodynamic function of the ALLEGRA bioprosthesis in valve-in-valve interventions.
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Sathananthan J, Fraser R, Kütting M, Hensey M, Landes U, Alkhodair A, Sedaghat A, Blanke P, Toggweiler S, Leipsic J, Søndergaard L, Wood D, and Webb JG
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- Aortic Valve, Hemodynamics, Hydrodynamics, Prosthesis Design, Prosthesis Failure, Terfenadine analogs & derivatives, Bioprosthesis, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Transcatheter Aortic Valve Replacement
- Abstract
Aims: We aimed to assess the impact of implant depth on hydrodynamic function following valve-in-valve (VIV) intervention using the ALLEGRA transcatheter heart valve (THV) in three different surgical valve designs., Methods and Results: Multiple implantation depths (+2 mm, -2 mm and -6 mm) were tested using a 23 mm ALLEGRA THV for VIV intervention in 19 mm, 21 mm, 23 mm, and 25 mm Epic, Mitroflow and Magna Ease bioprosthetic valves. Multimodality imaging and hydrodynamic evaluation was performed at each implantation depth. The 23 mm ALLEGRA valve had gradients <20 mmHg in the Mitroflow and Epic valves sized ≥21 mm, and in all sizes of the Magna Ease valve. Gradients did not increase significantly at lower implantation depths. The 19 mm Epic (+2 mm: 20.1±0.6 mmHg, -2 mm: 18.8±0.5 mmHg, -6 mm: 22.8±0.3 mmHg) and 19 mm Mitroflow (+2 mm: 24.1±0.2 mmHg, -2 mm: 31.5±0.3 mmHg, -6 mm: 25.6±0.2 mmHg) valves had elevated mean gradients. In larger sized surgical valves (≥23 mm) the regurgitant fraction was higher at low implantation depths. Pinwheeling was significantly worse in the smaller sized (≤21 mm) surgical valves and also at low (<-2 mm) implantation depth., Conclusions: The 23 mm ALLEGRA valve had favourable (<20 mmHg) gradients in all surgical valves sized ≥21 mm, even when the THV was implanted low. In 19 mm sized Mitroflow and Epic valves, gradients were elevated (>20 mmHg). While there was no major difference in mean transvalvular gradients, leaflet pinwheeling was worse at lower implantation depths.
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- 2020
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13. Long-Term Outcomes of the FORMA Transcatheter Tricuspid Valve Repair System for the Treatment of Severe Tricuspid Regurgitation: Insights From the First-in-Human Experience.
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Asmarats L, Perlman G, Praz F, Hensey M, Chrissoheris MP, Philippon F, Ofek H, Ye J, Puri R, Pibarot P, Attinger A, Moss R, Bédard E, Moschovitis A, Reineke D, Lauck S, Blanke P, Leipsic J, Spargias K, Windecker S, Webb JG, and Rodés-Cabau J
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- Aged, Aged, 80 and over, Canada, Cardiac Catheterization adverse effects, Cardiac Catheterization mortality, Compassionate Use Trials, Europe, Female, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation mortality, Humans, Male, Postoperative Complications mortality, Postoperative Complications therapy, Prosthesis Design, Recovery of Function, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, Tricuspid Valve diagnostic imaging, Tricuspid Valve physiopathology, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency mortality, Tricuspid Valve Insufficiency physiopathology, Cardiac Catheterization instrumentation, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation instrumentation, Hemodynamics, Tricuspid Valve surgery, Tricuspid Valve Insufficiency surgery
- Abstract
Objectives: To evaluate the long-term (≥2 years) outcomes following transcatheter tricuspid valve repair (TTVr) with the FORMA Transcatheter Tricuspid Valve Repair System (Edwards Lifesciences, Irvine, California)., Background: Scarce data exist on long-term outcomes following TTVr., Methods: This multicenter experience included patients with severe tricuspid regurgitation (TR) who underwent TTVr with the FORMA system at 4 centers under a compassionate clinical use program. Data were collected at baseline, 30 days, and 1 year, and yearly thereafter., Results: Nineteen patients (76 ± 9 years of age, 74% women, mean EuroSCORE II [European System for Cardiac Operative Risk Evaluation] 9.2 ± 5.6%) with functional TR were included. Procedural success was achieved in 17 (89%) patients and there were no cases of 30-day mortality. At a median follow-up of 32 (interquartile range: 24 to 36) months, 4 (24%) patients had died (3 from terminal heart failure, 1 from sepsis) and 3 (18%) patients required rehospitalization for heart failure. There was 1 device-related thrombosis and 1 pulmonary embolism, both in the setting of subtherapeutic oral anticoagulation. Less than severe TR was observed at echocardiography in 67% of patients at the 2- to 3-year follow-up. Among 15 successfully implanted patients with at least 24-month follow-up, significant improvements in New York Heart Association functional class (p < 0.001), 6-min walk test (+54 m; p = 0.016) and Kansas City Cardiomyopathy Questionnaire score (+16 points; p = 0.016) were observed, compared with baseline., Conclusions: TTVr using the FORMA system showed favorable long-term safety profile in high-surgical-risk patients, with sustained functional improvement and acceptable TR reduction up to 3 years., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2019
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14. Early experience with a purpose-designed temporary pacing guidewire for transcatheter valve implantation.
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Hensey M, Daniels D, Wood D, and Webb JG
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- Aortic Valve Stenosis diagnosis, Aortic Valve Stenosis physiopathology, Humans, Treatment Outcome, Ventricular Function, Left, Aortic Valve Stenosis therapy, Cardiac Pacing, Artificial methods, Heart Valve Prosthesis Implantation methods, Transcatheter Aortic Valve Replacement methods
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- 2019
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15. Percutaneous Transcatheter Mitral Valve Replacement: First-in-Human Experience With a New Transseptal System.
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Webb JG, Murdoch DJ, Boone RH, Moss R, Attinger-Toller A, Blanke P, Cheung A, Hensey M, Leipsic J, Ong K, Sathananthan J, Wood DA, Ye J, and Tartara P
- Subjects
- Aged, Canada, Echocardiography, Transesophageal methods, Equipment Design, Feasibility Studies, Female, Heart Septum surgery, Humans, Male, Recurrence, Risk Adjustment methods, Severity of Illness Index, Ventricular Function, Left, Cardiac Catheterization methods, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation methods, Mitral Valve diagnostic imaging, Mitral Valve surgery, Mitral Valve Insufficiency diagnosis, Mitral Valve Insufficiency physiopathology, Mitral Valve Insufficiency surgery
- Abstract
Background: Severe mitral regurgitation (MR) conveys significant morbidity and mortality, and surgical repair or replacement may not be a desirable option., Objectives: The purpose of this study was to evaluate the feasibility of a percutaneous transseptal transcatheter mitral valve replacement (TMVR) system., Methods: This first-in-human study was conducted between August 2017 and August 2018. The system comprises a nitinol dock, which encircles the chordae tendineae, and a balloon-expandable transcatheter heart valve. The dock and transcatheter heart valve form an ensemble, with the native mitral valve leaflets secured in between, thereby abolishing MR. Key inclusion criteria were severe symptomatic MR and high surgical risk; exclusion criteria included left ventricular ejection fraction <30% or screening suggesting unfavorable anatomy. The primary endpoint was technical success as defined by Mitral Valve Academic Research Consortium (MVARC) criteria at completion of the index procedure. The secondary endpoint was freedom from mortality, stroke, and device dysfunction (MR grade >1, mitral gradient >6 mm Hg, left ventricular outflow tract gradient >20 mm Hg) at 30 days., Results: Ten patients with severe MR of various etiologies (4 degenerative, 4 functional, and 2 mixed) were treated. The device was successfully implanted and the primary endpoint was achieved in 9 of 10 patients (90%). By transesophageal echocardiography, total MR was reduced to ≤ trivial in all implanted patients, and mean transmitral gradient was 2.3 ± 1.4 mm Hg. A pericardial effusion occurred in 1 patient: pericardiocentesis was performed, and the device was not implanted. Median length of hospital stay was 1.5 days. At 30 days, there was no stroke, myocardial infarction, rehospitalization, left ventricular outflow tract obstruction, device migration, embolization, or conversion to mitral surgery. One patient had recurrent regurgitation due to a paravalvular leak, treated with a closure device. All other treated patients had ≤1+ MR. No patients died., Conclusions: Percutaneous transvenous transseptal TMVR is feasible and safe in patients with severe MR who are at high risk for mitral valve surgery. Further evaluation is warranted., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2019
- Full Text
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16. Transcatheter Tricuspid Valve-in-Valve Replacement With Subsequent Bioprosthetic Valve Fracture to Optimize Hemodynamic Function.
- Author
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Hensey M, Alenezi AR, Murdoch DJ, Sathananthan J, Weir-McCall JR, Wood D, Blanke P, and Webb J
- Subjects
- Adult, Female, Heart Valve Prosthesis Implantation adverse effects, Humans, Prosthesis Design, Prosthesis Failure, Recovery of Function, Treatment Outcome, Tricuspid Valve diagnostic imaging, Tricuspid Valve physiopathology, Tricuspid Valve Insufficiency diagnostic imaging, Tricuspid Valve Insufficiency etiology, Tricuspid Valve Insufficiency physiopathology, Tricuspid Valve Stenosis diagnostic imaging, Tricuspid Valve Stenosis etiology, Tricuspid Valve Stenosis physiopathology, Balloon Valvuloplasty, Bioprosthesis, Cardiac Catheterization instrumentation, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation instrumentation, Hemodynamics, Tricuspid Valve surgery, Tricuspid Valve Insufficiency surgery, Tricuspid Valve Stenosis surgery
- Published
- 2018
- Full Text
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17. TAVR and SAVR in ESRD: Just because we can doesn't necessarily mean that we should.
- Author
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Hensey M and Webb JG
- Subjects
- Aortic Valve surgery, Humans, Risk Factors, Treatment Outcome, Aortic Valve Stenosis surgery, Heart Valve Prosthesis Implantation, Kidney Failure, Chronic, Transcatheter Aortic Valve Replacement
- Abstract
In patients with end stage renal disease on hemodialysis, TAVR resulted in reduced length of stay, hospitalization cost, complication rate and higher rates of home discharge compared to SAVR. In-hospital mortality and complication rates were high in both groups. Careful patient selection and further research is required to identify patients with end-stage renal disease who might, or might not, benefit from intervention., (© 2018 Wiley Periodicals, Inc.)
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- 2018
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18. Transcatheter Tricuspid Valve-in-Valve Replacement With Subsequent Bioprosthetic Valve Fracture to Optimize Hemodynamic Function
- Author
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Hensey, Mark, Alenezi, Abdullah R, Murdoch, Dale J, Sathananthan, Janarthanan, Weir-McCall, Jonathan R, Wood, David, Blanke, Philipp, and Webb, John
- Subjects
Adult ,Balloon Valvuloplasty ,Bioprosthesis ,Heart Valve Prosthesis Implantation ,Cardiac Catheterization ,transcatheter valve ,Hemodynamics ,Recovery of Function ,tricuspid valve ,Prosthesis Design ,Tricuspid Valve Insufficiency ,Prosthesis Failure ,Treatment Outcome ,Heart Valve Prosthesis ,Humans ,Female ,Tricuspid Valve Stenosis - Published
- 2018
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19. Trans-femoral aortic valve implantation through unrepaired aortic co-arctation.
- Author
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Butt, Zaran A, Almagal, Naeif, O'Connor, Stephen, and Hensey, Mark
- Subjects
AORTIC valve ,HEART valve prosthesis implantation ,MITRAL valve ,AORTA ,BRONCHIECTASIS ,AORTIC valve insufficiency ,PATIENT selection ,AORTIC stenosis - Published
- 2023
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20. TCT-758 Assessment of Bioprosthetic Valve Leaflet Displacement During Valve-in-Valve TAVI; an Ex-Vivo Bench Study.
- Author
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Hensey, Mark, Sathananthan, Janarthanan, Sellers, Stephanie, Lai, Althea, Landes, Uri, Alkhodair, Abdullah, Cheung, Anson, Blanke, Philipp, Leipsic, Jonathon, Wood, David, Ye, Jian, and Webb, John
- Subjects
- *
VALVES , *PAMPHLETS , *HEART valve prosthesis implantation - Published
- 2019
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21. TCT-736 Long-Term Durability of Transcatheter Heart Valves: Insights From Bench Testing to 25 Years.
- Author
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Sathananthan, Janarthanan, Hensey, Mark, Landes, Uri, Alkhodair, Abdullah, Saiduddin, Adeeb, Sellers, Stephanie, Cheung, Anson, Lauck, Sandra, Blanke, Philipp, Leipsic, Jonathon, Ye, Jian, Wood, David, and Webb, John
- Subjects
- *
HEART valves , *DURABILITY , *HEART valve prosthesis implantation - Published
- 2019
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22. TCT-33 Bioprosthetic Valve Fracture Performed Pre– Versus Post–Valve-in-Valve Transcatheter Aortic Valve Replacement: Insights From Bench Testing.
- Author
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Sathananthan, Janarthanan, Fraser, Rob, Hatoum, Hoda, Barlow, Aaron, Stanová, Viktória, Hensey, Mark, Landes, Uri, Alkhodair, Abdullah, Sellers, Stephanie, Cheung, Anson, Ye, Jian, Allen, Keith, Chhatriwalla, Adnan, Blanke, Philipp, Rieu, Régis, Pibarot, Philippe, Dasi, Lakshmi, Leipsic, Jonathon, Wood, David, and Webb, John
- Subjects
- *
HEART valve prosthesis implantation , *VALVES - Published
- 2019
- Full Text
- View/download PDF
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