CTRL + SPACE for auto-complete. Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Pulmonary Hypertension and Venous Thromboembolism, ACC Anywhere The ACC.22 Meeting on Demand Program, CardioSource Plus for Institutions and Practices, Annual Scientific Session and Related Events, ACC Quality Improvement for Institutions Program, National Cardiovascular Data Registry (NCDR). Despite the high demand for these new technologies, data comparing the performance of the PASCAL versus MitralClip-XTR systems are absent. 1). Most of the participating sites did not have prior experience with the Pascal device prior to CLASP IID, the researchers point out. Cardioband's pivotal US trial, Active, is on hold, however, so Edwards can reassess the protocol. PASCAL The Pascal device received CE Mark approval in 2019 and has some features that distinguish it from the MitraClip device. The CLASP IIF study is also ongoing. Sugiura, A., Vogelhuber, J., ztrk, C. et al. . Multiple device implantation was the most common form (59% vs. 82%, p = 0.19), and the occurrence of SLDA was comparable between the PASCAL and MitraClip-XTR system (5.7% [2 of 35 implanted devices] vs. 4.4% [2 of 45 implanted devices], p = 0.99). Another panelist, David Cohen, MD (St. Francis Hospital, Roslyn, NY), pointed out there is observational data suggesting that achieving. We saw a 50% reduction to grade 2+or less for PASCAL and 68% for XTR after 30days without any significance between groups (p=0.56). https://doi.org/10.1007/s00392-020-01784-w, DOI: https://doi.org/10.1007/s00392-020-01784-w. A potential explanation for different TR reduction could be SLDA. The primary endpoint was similarly observed in both groups (PASCAL: 91% vs. MitraClip-XTR: 96%). JACC Cardiovasc Interv 11(12):11191128, Nickenig G, Weber M, Lurz P, von Bardeleben RS, Sitges M, Sorajja P, Hausleiter J, Denti P, Trochu JN, Nbauer M et al (2019) Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm study. The Infona portal uses cookies, i.e. Gerek M, Roder F, Rudolph TK, Fortmeier V, Zittermann A, Rudolph V, Friedrichs KP. Multiple device implantation was the most common form (59% vs. 82%, p = 0.19), and the occurrence of SLDA was comparable between the PASCAL and MitraClip-XTR system (5.7% [2 of 35 implanted devices] vs. 4.4% [2 of 45 implanted devices], p = 0.99). The PS-matched cohort (n = 44) was at high-surgical risk (EuroSCORE II: 7.5% [interquartile range (IQR) 4.8-12.1%]) with a mean TR grade of 4.3 0.8 and median coaptation gap of 6.2 mm [IQR 3.2-9.1 mm]. Symptomatic capacity, such as New York Heart Association (NYHA) functional class and 6-min walking distance and the Medical Outcomes Study Short-Form (SF-36) Health Survey, was also evaluated [15]. Procedures were performed under general anesthesia with 2D- and 3D-TEE and fluoroscopic guidance. This approval was denied because FDA did not feel that MitraClip . Share via: Print; Font Size A A A. Author/Summarized by Author: Dharam J. Kumbhani, MD, SM, FACC Summary Reviewer: Deepak L. Bhatt, MD, MPH, FACC Trial Sponsor: Edwards Lifesciences Date Presented: 09/17/2022 In 86.4% of the patients a residual MR grade 1 + was achieved with PASCAL whereas reduction to MR grade 1 + with MitraClip was achieved in 62.5%. While Abbott and Edwards have both developed tricuspid products Edwards with Pascal and Abbott's TriClip device, which is built on a MitraClip design Cleveland questioned if the tricuspid market would take off until a device is developed specifically for the valve. Several limitations should be acknowledged. Weve been building a lot of data with MitraClip as a device, but as a composite, its important to now show that TEER works. One explanation could be related to acute tricuspid valve remodeling after clipping. Before 2019;12(3):389397. Timing of the study does affect outcomes, our meta-analysis has included studies between 2014 and 2017, which do not reflect the use of newer devices such as PASCAL (Edwards Lifesciences Corp, Irvine, CA, USA) transcatheter valve repair system as all our studies were on MitraClip only. Besler et al. Google Scholar. Lim said that one advantage of MitraClip is the extent of operator experience, noting that operators may lean towards it because they are comfortable implanting it. In its comparison with MitraClip, the PASCAL transcatheter valve repair system (Edwards Lifesciences) was noninferior with respect to 30-day major adverse events and to success at achieving. Pauls Hospital, Vancouver, Canada), who wasnt involved in the study, echoed Aschs comments. First-in-Human Experience JACC Cardiovasc Interv 12(24):24882495, Nickenig G, Weber M, Schueler R, Hausleiter J, Nbauer M, von Bardeleben RS, Sotiriou E, Schfer U, Deuschl F, Kuck KH et al (2019) 6-Month outcomes of tricuspid valve reconstruction for patients with severe tricuspid regurgitation. The MitraClip System (NTR device) has been utilized for TTVR since 2015, while the PASCAL system is available since November 2018. and 8.6% (Triluminate cohort) [5, 9]. Clinical trials must also incorporate sequential or combined treatmentseven if they are challenging to designbecause they are likely to be used in clinical practice when more than one device becomes available. double, where the respective device (PASCAL or MitraClip) was implanted in both the central and lateral location. In the PS-matched cohort, implantation success was achieved in 20 (91%) patients in the PASCAL group and 21 (96%) in the MitraClip-XTR group. JACC Cardiovasc Interv. Mean age and left ventricular ejection fraction was similar in both groups. MitraClip is the First and Only TMV r * therapy shown to improve survival in secondary MR 2,3 Dramatic improvement in health-related quality of life 4 MitraClip patients were 2.5 times more likely to experience a large improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to patients receiving standard care 4 Procedural findings in the overall cohort are summarized in Supplemental Table 2, and those in the PS-matched cohort are shown in Table 2. Write CSS OR LESS and hit save. Unable to load your collection due to an error, Unable to load your delegates due to an error, Change in the grade of tricuspid regurgitation. 3. In this PS-matched cohort, we found that edge-to-edge treatment with either the PASCAL or the MitraClip-XTR device was feasible, effective, and safe in patients with severe tricuspid regurgitation and was associated with clinical improvement. The authors point to some of the possible advantages of PASCAL over MitraClip, including wider paddles, the ability to independently grasp leaflets, and the presence of a central spacer. PASCAL poised to rival MitraClip for safety and efficacy 27th June 2019 6460 Samir Kapadia PASCAL's (Edwards Lifesciences) safety and efficacy may rival that of MitraClip (Abbott) for the treatment of mitral regurgitation (MR), according to data published in JACC: Cardiovascular Interventions. We conducted one-to-one matching based on the PS with the nearest-neighbor algorithm method. It is mirrored in at least two other publications out of Europe that when they compared [Pascal] to MitraClip, [they] seemed to find a decrease in efficacy with the MitraClip patients. Epub 2020 Dec 7. By now, the two devices, PASCAL and TriClip, are CE certified. Trends toward the improvement of these variables were seen in both groups. There are going to be patients who are better candidates for one [device] or another. JACC Cardiovasc imaging 7(12):11851194, Article Background: He concluded that this first-in-human experience of the PASCAL system for tricuspid regurgitation indicated that the system was associated with high procedural success, acceptable safety and significant clinical improvement in patients with challenging tricuspid anatomy and severe tricuspid regurgitation. These patients were managed conservatively with optimal medical therapy. With respect to major adverse eventsa composite safety endpoint that included cardiovascular death, stroke, MI, need for renal replacement therapy, severe bleeding, and nonelective mitral valve reinterventionthe Pascal system met the margin for noninferiority when compared with MitraClip (3.4% with Pascal vs 4.8% with MitraClip). As of October 2013, the MitraClip device has been implanted in over 11,000 patients. Whether TR reduction is associated with improvement in relevant clinical outcomes parameters such as mortality and rehospitalization has to be answered in future studies. Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community! NYHA functional class at baseline and follow-up. standard-setting clinical outcomes that never stand still, mitraclip is the only teer therapy with positive durable outcomes to 5 years. CLASP IID also reinforces the benefits of edge-to-edge repair. Among those is a central spacer designed to fill the regurgitant orifice, further reducing MR. Federal government websites often end in .gov or .mil. Both TTVR devices, PASCAL and MitraClip-XTR, appeared feasible and comparable for an effective TR reduction and Randomized head-to-head comparisons will help to further define the appropriate scope of application of each system. Google Scholar, Bartko PE, Arfsten H, Frey MK, Heitzinger G, Pavo N, Cho A, Neuhold S, Tan TC, Strunk G, Hengstenberg C et al (2019) natural history of functional tricuspid regurgitation: implications of quantitative doppler assessment. The PASCAL Device-Early Experience with a Leaflet Approximation Device: What Are the Benefits/Limitations Compared with the MitraClip? Correspondence to 2021 Aug 31:S0914-5087(21)00204-5. doi: 10.1016/j.jjcc.2021.08.008 Significant and durable MR reduction in all aetiologies 12. Telephone interviews were also performed with the patients general practitioners or family. Clinical and Echocardiographic Outcomes of Transcatheter Tricuspid Valve Interventions: A Systematic Review and Meta-Analysis. TEE was performed at baseline and during the procedure with a Vivid E95 ultrasound system (GE health care, GE Healthcare, Illinois, USA). Eur Heart J Cardiovasc Imaging 20(9):10351042, Fisicaro A, Sticchi A, Mangieri A, Laricchia A, Squeri A, Colombo A (2020) Giannini F (2020) Acute tricuspid valve remodeling after MitraClip deployment: rationale for a dual-staged procedure. doi: 10.1016/j.jcmg.2018.11.021. The mortality rate was 1.6% in the early feasibility study, and 13% in the compassionate use group, with no strokes in either cohort. The early experience attests to the feasibility of the procedure and further studies will be instrumental to define the appropriate use and indication for this novel device., The researchers add: This is probably the most strategic era for the evolution of percutaneous mitral valve therapies. Ann Am Thorac Soc 15(2):184191, Orban M, Rommel KP, Ho EC, Unterhuber M, Pozzoli A, Connelly KA, Deseive S, Besler C, Ong G, Braun D et al (2020) Transcatheter edge-to-edge tricuspid repair for severe tricuspid regurgitation reduces hospitalizations for heart failure. During the study period, 80 patients were treated with the PASCAL or MitraClip-XTR systems for the treatment of TR. In both the Triluminate trial and our analysis, a five-class grading scheme was used to assess the severity of TR [12], as massive or torrential TR, which are included in the five-class grading, are associated with a higher risk of death and readmission of HF [20]. Investigational Device Exemption (IDE) Number: G190212 CMS Approval Date: 07/17/2020. 2 and for the PS-matched cohort in Fig. -, Bartko PE, Arfsten H, Frey MK, Heitzinger G, Pavo N, Cho A, Neuhold S, Tan TC, Strunk G, Hengstenberg C, et al. J Am Coll Cardiol 73(17):21232132, Goto T, Hirayama A, Faridi MK, Camargo CA Jr, Hasegawa K (2018) Obesity and severity of acute exacerbation of chronic obstructive pulmonary disease. However, since its introduction in 2003, the MitraClip device has had only minimal modification and the intervention is associated with some intrinsic limitations, including manoeuvrability of the system and implant dimensions that restrict its use in complex anatomical settings. 3). Sathananthan pointed out that CLASP IID does have limitations, most notably the low patient numbers. Similarly, in the sensitivity analysis, there were no significant differences between the groups in the 30-day mortality (OR 0.92, 95% CI 0.099.89, p=0.95) or 3-month mortality (OR 0.89, 95% CI 0.165.03, p=0.89). [10] reported 87% in 31 XTR patients, and Fam et al. Randomized head-to-head comparisons will help to further define the appropriate scope of application of each system. In one patient treated with the MitraClip-XTR system, the second device was tangled with chordaealthough the first device could previously been deployed successfully. GN has received research funding from the Deutsche Forschungsgemeinschaft, the German Federal Ministry of Education and Research, the EU, Abbott, AGA Medical, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronic, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St Jude Medical, and has received honoraria for lectures or advisory boards from Abbott, AGA Medical, AstraZeneca, Bayer, Berlin, Cardiovalve, Berlin Chemie, Biosensus, Biotronic, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St Jude Medical. PASCAL was available in two sizes (original and narrow Ace). The PS-matched cohort (n=44) was at high-surgical risk (EuroSCORE II: 7.5% [interquartile range (IQR) 4.812.1%]) with a mean TR grade of 4.30.8 and median coaptation gap of 6.2mm [IQR 3.29.1mm]. All of this is positive for the field.. However, other groups investigating the performance of XTR [10] or PASCAL [5] rather stated the percentage of reduction to grade 2+or less at 30-day follow-up (6985%). Results: JACC Cardiovasc Interv 12(15):14381447, Fam NP, Braun D, von Bardeleben RS, Nabauer M, Ruf T, Connelly KA, Ho E, Thiele H, Lurz P, Weber M et al (2019) Compassionate use of the PASCAL transcatheter valve repair system for severe tricuspid regurgitation: a multicenter, observational. Annular diameter reduction and pulling up leaflets caused by a first clip can facilitate to deploy the second clip correctly [21]. Federico Asch, MD (MedStar Health/Georgetown University, Washington, DC), who wasnt involved in CLASP IID, congratulated the researchers, saying the field has now entered a new era. A newly available transcatheter device for edge-to-edge mitral valve (MV) repair, named for a famed scientist-inventor, is similar to the long-available MitraClip (Abbott Vascular) for short-term efficacy and safety, suggests an interim but prespecified analysis from a randomized trial.. CRF is committed to igniting the next wave of innovation in research and education that will help doctors save and improve the quality of their patients lives. All patients participated in the study after written informed consent was obtained. I dont think we have that answer right now. Tricuspid regurgitation (TR) is no longer called a forgotten valvular disease. Instead, TR has turned out as a prognostic devastator. 2022 American College of Cardiology Foundation. Corpataux N, Winkel MG, Kassar M, Brugger N, Windecker S, Praz F. Curr Cardiol Rep. 2020 Jun 27;22(8):74. doi: 10.1007/s11886-020-01305-1. Transcatheter tricuspid valve repair (TTVR) is a promising technique for the treatment of tricuspid regurgitation (TR). There were no significant difference in 30-day (5.0% vs. 5.0%, log-rank p=0.99) or 3-month mortality between both groups (10.0% vs. 5.0%, log-rank p=0.56). Therefore, a certain patient selection bias might have impacted our results, and the analysis might be underpowered. In that study, investigators are comparing Pascal to MitraClip in patients with functional MR and prohibitive surgical risk. One of the biggest stories coming out of Transcatheter Cardiovascular Therapeutics' annual meeting in Boston this weekend focuses on the success of Edwards Lifesciences Corp.'s freshly FDA-approved Pascal Precision transcatheter valve repair system in the CLASP IID trial, which compared it to Abbott Laboratories' Mitraclip device in patients with degenerative mitral regurgitation (DMR . Randomized comparison of transcatheter edge-to-edge repair for degenerative mitral regurgitation in prohibitive surgical risk patients. 2020 Feb;17(2):93-102. doi: 10.1080/17434440.2020.1714433. BOSTON A novel mitral valve transcatheter edge-to-edge repair system was noninferior to an existing system in a head-to-head trial in patients with severe symptomatic degenerative mitral regurgitation, researchers reported at TCT 2022. SF-36 PCS Short-Form 36 Health Survey physical summary score, SF-35 MCS Short-Form 36 Health Survey mental summary score. However, it has not been compared against more novel therapies (such as the PASCAL system). The https:// ensures that you are connecting to the Our matched groups showed a similar safety and efficacy profile, despite lacking the optional independent clasping in the MitraClip-XTR system. 2019;12(24):24882495. Both procedures amount to an edge-to-edge-approach for valve-repair. For example, Pascals hollow nitinol-frame construction allows it to close passively and flex during systole and diastole. . Would you like email updates of new search results? In Europe, CE mark was received in March 2008. On average, the number of devices was significantly lower in the PASAL group (1.60.8 vs. 2.00.7, p=0.04). Careers. Authors He completed his undergraduate degrees at Queens. Randomized trials investigating the effect for both devices compared to optimal medical treatment on reducing TR are ongoing (Triluminate Pivotal Trial, NCT: 03,904,147; Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial, NCT: 04,097,145). In addition, independent leaflet grasping is possible with the PASCAL device. Third, although the main concept of both systems is identical (edge-to-edge repair), the difference regarding the learning curve in each system might affect the procedural outcomes. Our PS matching aimed to create two almost equal cohorts to overcome selection bias and any anatomic imbalance. Shown are changes in 6-min walking, MeSH have reported that successful transcatheter TR reduction was associated with a reduced risk of mortality [8, 17]. It may bear out, but right now its a little early to say.. In one patient treated with the PASCAL system, implantation was not feasible due to a pronounced coaptation gap. Email: [emailprotected] Epub 2022 Mar 29. After a standardized diagnostic workup including transesophageal echocardiography (TEE), the decision to perform the intervention was taken by the interdisciplinary heart team of the Heart Center Bonn. Braun and Fam et al. Previous cohort studies demonstrated a clear association between significant TR and excess mortality and reduced quality of life (QOL) [1, 2]. Int J Cardiol. Efficacy and safety endpoint Study population. In terms of effectiveness, the proportion of patients with MR 2+ at 6 months 96.5% with Pascal and 96.8% with MitraClip. A total of 120 patients (88 Mitraclip XTR vs. 32 PASCAL recipients) treated in a single center were included. Clin Res Cardiol 110, 451459 (2021). The baseline characteristics were comparable between the groups, including age, sex, NYHA functional class, EuroSCORE II, left-ventricular ejection fraction, concomitant MR, right atrial area, tricuspid annulus diameter, coaptation gap, EROA, vena contracta, regurgitant volume, and TR jet location. For example, Pascals hollow nitinol-frame construction allows it to close passively and flex during systole and diastole. However, interim analyses were planned for 180, 210, and 240 patients provided the sample size was deemed sufficient for analyzing the primary endpoint. JACC Cardiovasc imaging. Bookshelf Survival curves are depicted for the overall cohort in Supplemental Fig. I dont think we have that answer right now. Each group showed a significant reduction in tricuspid regurgitation from baseline to 30-day follow-up. The trial is designed to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL system compared with the Abbott MitraClip device, for the treatment of moderate-to-severe (3+) or severe (4+) functional mitral regurgitation (FMR) in symptomatic heart failure patients. Life-Changing TEER Therapy for Select Patients with Mitral Regurgitation. The CLASP IID trial is the first randomized, controlled trial to directly compare the two TEER therapies and further establishes the safety and effectiveness of mitral valve TEER for degenerative mitral regurgitation patients with prohibitive surgical risk, said study investigator Konstantinos Koulogiannis, MD (Atlantic Health System Morristown Medical Center, NJ), during a press conference. But they caution: It remains to be seen if more complex anatomies (for example, larger flail segments, large prolapse, cleft, short posterior leaflet) or smaller mitral valve areas (for example, patients with mitral annular calcification) can be preferentially treated with PASCAL., Because of differences between the devices in the shape, size, and tension exerted on the leaflets, head-to-head comparison trials are necessary, they say, as well as registries of patients with unique anatomies, to aid clarity. I think its beneficial to have another device to offer TEER as an option, he said. A paired t test was used to compare a series of variables with regard to symptomatic functional capacity (i.e., 6MWD and 36-SF). In the TCT 2022 presentation, results indicated the PASCAL system demonstrated noninferiority compared to the MitraClip system for the primary safety endpoint, with major adverse event rates of 3.4% and 4.8%, respectively. Interestingly, the technical characteristics of the PASCAL devices may also be advantageous for the treatment of the regurgitant tricuspid valve that is characterised by thin leaflets and larger coaptation defects.. There are ongoing studies comparing TEER with MitraClip versus surgical mitral valve repair in patients with degenerative MR. One of those studies, PRIMARY, is a superiority trial funded by the National Institutes of Health with a planned enrollment of 450 patients at all levels of surgical risk. The MitraClip TMVr procedurealso referred to as TEER (transcatheter edge-to-edge repair)is a minimally invasive catheter-based therapy performed by multidisciplinary Heart Teams. Both were well matched, but those who received the Pascal device were more likely to have undergone prior aortic valve surgery or TAVI. 2022 Springer Nature Switzerland AG. Clipboard, Search History, and several other advanced features are temporarily unavailable. MW has received lecture or proctoring fees from Abbott, Boehringer-Ingelheim, Edwards Lifesciences, Neochord, Pfizer, and Servier. In the MitraClip group, there was one cardiovascular death and two severe bleeds. Standardized differences were reported for baseline characteristics. Clinical outcomes were prospectively assessed during scheduled hospital visits. Although the device generations improved over couple . -, Asmarats L, Perlman G, Praz F, Hensey M, Chrissoheris MP, Philippon F, Ofek H, Ye J, Puri R, Pibarot P, et al. Second, clinical outcomes and echocardiographic findings were not adjudicated by a central Core-Lab. Lancet (London, England) 394(10213):20022011, Braun D, Rommel KP, Orban M, Karam N, Brinkmann I, Besler C, Massberg S, Nabauer M, Lurz P, Hausleiter J (2019) Acute and short-term results of transcatheter edge-to-edge repair for severe tricuspid regurgitation using the MitraClip-XTR system. The occurrence of SLDA was similar between the groups (5.7% [2 of 35 implanted devices] vs. 4.4% [2 of 45 implanted devices], p=0.99). Email: [emailprotected] PMC Interventions and Structural Heart Disease, Invasive CV Angiography and Intervention Clinical Topic Collection, Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial, FDA Update: Transcatheter System For Degenerative Mitral Regurgitation Approved, Insight From Dissection of the Methodology and Findings of the CAPLA Study, Feature | TCT 2022: My Interventional Takeaways, Can a Noninvasive CT Scan Prior to Invasive Coronary Angiography Improve Procedural Outcomes in Patients With Prior Coronary Artery Bypass Grafting, Eagle's Eye View: Day 3 Highlights | TCT 2022, Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Pulmonary Hypertension and Venous Thromboembolism. The spacer also reduces leaflet approximation force, leading to less tension on the leaflets. NYHA functional class improved in the PASCAL group (NYHA I/II: 5% at baseline to 93% at follow-up) and in the MitraClip-XTR group (NYHA I/II: 13% to 82%). Even more substantial would be a randomized head-to-head comparison between these two TTVR devices and optimal medical therapy. The armamentarium for transcatheter mitral repair is rapidly expanding, with up to five devices already approved for use in Europe: MitraClip (Abbott), Pascal (Edwards Lifesciences), the DS1000 device (NeoChord, Inc.), Carillon (Cardiac Dimensions, Inc.), and Cardioband (Edwards Lifesciences). TEL: +1 949 723 9309 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. Up to now, leaflet approximation devices for edge-to-edge repair are most frequently used for transcatheter tricuspid valve reconstruction. Recent encouraging results of transcatheter tricuspid valve repair (TTVR) have been observed with different technologies [3,4,5,6], and transcatheter edge-to-edge repair is the most prevalent technique for leaflet approximation [7]. In this propensity score matched comparison of the two available edge-to-edge repair techniques, we found that both devicesPASCAL and MitraClip-XTRshowed similar acute procedural success rates with proven feasibility, safety, and a significant reduction in TR after TTVR. Randomized head-to-head comparisons will help to further define the appropriate scope of application of each system. Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial - CLASP II D. Sep 17, 2022 . All rights reserved. PASCAL versus MitraClip-XTR edge-to-edge device for the treatment of tricuspid regurgitation: a propensity-matched analysis Clin Res Cardiol. Due to the high-surgical risk in this population, a catheter-based and minimally invasive procedure is thought to be promising to reduce TR safe and effective without excess periprocedural risk. We would like to thank Dr. Meghan Campbell (scientific coordinator for the Heart Center Bonn, Bonn, Germany) for proofreading the manuscript. The PASCAL system was available from February 2019 (off-label use) and commercially available since May 2020. The goal of this activity is for learners to be better able to improve understanding of the latest data for the use of TEER to treat DMR. By using the Infona portal the user accepts automatic saving and using this . Current cardiology reports 22(8):74, Hahn RT, Zamorano JL (2017) The need for a new tricuspid regurgitation grading scheme. Researchers randomized patients with 3+ or 4+ DMR at prohibitive surgical risk to PASCAL or MitraClip. Compassionate use of the PASCAL transcatheter valve repair system for severe tricuspid regurgitation: a multicenter, observational. 2022 Sep;30(9):393-399. doi: 10.1007/s12471-022-01673-z. N number of patients. The two devices have different design features that I think may be beneficial in different anatomies, said Lim. Disclaimer, National Library of Medicine NYHA functional class improved in the PASCAL group (NYHA I/II: 5% at baseline to 93% at follow-up) and in the MitraClip-XTR group (NYHA I/II: 13% to 82%). Comparison of transcatheter tricuspid valve repair using the MitraClip NTR and XTR systems. Enter the email you used to register to reset your password. For more information, visit http://www.crf.org. Lim and colleagues added that "continued patient follow-up to five years will confirm long-term outcomes with the PASCAL system in comparison to the MitraClip system. 13 Furthermore, nearly 50% of all MR patients will be denied valve replacement surgery due to . The site is secure. The primary safety endpoint was a composite of major adverse event (MAE) at 30 days, while the primary effectiveness endpoint was the proportion of patients with mitral regurgitation (MR) 2+ at six months. Eur Heart J Cardiovasc Imaging 18(12):13421343, Falk V, Baumgartner H, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Munoz DR et al (2017) 2017 ESC/EACTS Guidelines for the management of valvular heart disease. 74% of eligible patients with primary MR were not referred for surgery for valve replacement. See this image and copyright information in PMC. There are only a few publications accessible for off-label use of MitraClip-XTR in a tricuspid position [10, 18, 19] and one for PASCAL in a tricuspid position [5], which serve as a basis for comparison. A reduction of MR to grade 1+ was obtained in 86% of the treated patients in the early feasibility study and 77% of those in the compassionate use cohort, a finding, say Praz and colleagues, that may be explained by the more liberal implantation of two devices in 49% of cases (26% during the CU experience). To TCTMD, Sathananthan said one of the conundrums faced by operators whove performed edge-to-edge repair is that the severity of MR can be underestimated immediately after the procedure. Consequently, TR2+at 30days was observed in 11 (50%) patients in the PASCAL group and 15 (68%) patients in the MitraClip-XTR group (p=0.56). The primary endpoint was a reduction in TR severity by at least one grade at 30days. Expert Rev Med Devices. After PS matching, 22 pairs of matched patients were identified. The main differences include the device properties (MitraClip: cobalt-chromium; PASCAL: nitinol), the central spacer and broader paddles of the PASCAL device. The results, which were presented as a late-breaking clinical trial at TCT 2022 and published simultaneously in JACC: Cardiovascular Interventions, come just 2 days after the US Food and Drug Administration approved the Pascal transcatheter edge-to-edge repair (TEER) system for the treatment of degenerative MR, making it just the second device available in the US. Background Transcatheter tricuspid valve repair (TTVR) is a promising technique for the treatment of tricuspid regurgitation (TR). 2021 Mar;110 (3):451-459. doi: 10.1007/s00392-020-01784-w. Epub 2020 Dec 12. Keywords: Major bleeding occurred in 6.5% of cases in the early feasibility group, compared to 0% among those treated for compassionate use. At 6 months, 83.7% of the Pascal-treated patients and 71.2% of the MitraClip-treated patients had sustained MR 1+, suggesting there was some loss of efficacy over the same course of follow-up with MitraClip, according to investigators. If a difference between MitraClip and Pascal emerges with respect to these sustained MR reductions, he said, it could be a factor when choosing devices. Functional and hemodynamic results after transcatheter mitral valve leaflet repair with the PASCAL device depending on etiology in a real-world cohort J Cardiol. Patients in both treatment arms had significant improvements in functional capacity and quality of life when compared with baseline, but there was no difference between devices. Up to 300 patients are planned for enrollment. During follow-up, functional NYHA class, 6-min walking distance, and health status improved in both groups. For a better comparison, baseline risk scores of different studies have to be mentioned, which all range in a moderately-to-highly elevated operation riskestimated by EuroSCORE IIbetween 6.2 (PASCAL report by Fam et al.) After device placement, the acute reduction in TR was quantified. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. All measurements were reviewed by two independent cardiologists dedicated to echocardiographic evaluation. Please enable it to take advantage of the complete set of features! The primary endpoint was similarly observed in both groups (PASCAL: 91% vs. MitraClip-XTR: 96%). Two-tailed p values<0.05 were regarded as statistically significant. AS, JV, C, ZS, DR, TG, RK, MUB, and SZ have no conflicts of interest. The PASCAL device was modeled as two separate bodies: 1) a spacer, and 2) a set of two paddles. We identified 80 consecutive patients who underwent TTVR using either the PASCAL or MitraClip-XTR system to treat symptomatic TR from July 2018 to June 2020. Neil P Fam (Division of Cardiology, St Michaels Hospital, University of Toronto, Toronto, Canada) outlined a multicentre experience of compassionate use of the PASCAL system for patients with severe tricuspid regurgitation. and transmitted securely. The other study is REPAIR MR, a noninferiority study, testing MitraClip versus valve repair surgery in degenerative MR patients at intermediate risk. reported a 30-day mortality of 7.1% [5]. Then, at follow-up, its not uncommon for MR to be a little bit higher than expected. Procedural success was high in the early feasibility study, with MR grade 2+ in 98% of patients. J Am Coll Cardiol 73(15):19051915, Taramasso M, Alessandrini H, Latib A, Asami M, Attinger-Toller A, Biasco L, Braun D, Brochet E, Connelly KA, Denti P et al (2019) Outcomes after current transcatheter tricuspid valve intervention: mid-term results from the International TriValve Registry. 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Coupled with the improvement of NYHA, the amelioration of the 6-min walk distance and the SF-36 questionnaires support our findings' validity. We assessed echocardiographic parameters performed at baseline, 30days, and follow-up [9]. Implantation of at least one PASCAL device was successful in . The Clasp IID study of Pascal in degenerative or primary mitral regurgitation will report in 2021, and a study in functional or secondary MR is due to start this year. Total number of enrollees: 180 Duration of follow-up: 6 months Mean patient age: 81 years Percentage female: 33% Inclusion criteria: . JACC Cardiovasc Interv 12(2):155165, Besler C, Orban M, Rommel KP, Braun D, Patel M, Hagl C, Borger M, Nabauer M, Massberg S, Thiele H et al (2018) Predictors of procedural and clinical outcomes in patients with symptomatic tricuspid regurgitation undergoing transcatheter edge-to-edge repair. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. Nevertheless, we used PS-matching analysis to overcome selection bias and any anatomic imbalance. The Pascal system has CE Mark approval in Europe for both MR and tricuspid regurgitation. Change in the grade of tricuspid regurgitation. Although it is not a perfect repair, other options like annuloplasty or transcatheter valve replacement are either complex or still in the early stages of clinical investigation. Weighting subjects by the inverse probability to have an exposure (PASCAL) creates a synthetic sample in which the exposure is independent of measured baseline covariates. In the PS-matched cohort, with a median follow-up period of 5.0months (IQR 3.1, 9.7months), three patients had died during the first 3months. I dont think we have that answer right now, he said. Part of Springer Nature. Another panelist, David Cohen, MD (St. Francis Hospital, Roslyn, NY), pointed out there is observational data suggesting that achieving MR 1+ is better for patients with degenerative MR. We identified consecutive patients who underwent a TTVR using the PASCAL or MitraClip-XTR systems from April 2018 to June 2020. Speaking with TCTMD, Janarthanan Sathananthan, MBChB (University of British Columbia/Vancouver General Hospital/St. The pivotal CLASP IID/F randomized trial has begun enrolment, and will compare the efficacy and safety of PASCAL vs. MitraClip in patients with significant DMR or FMR, using a non-inferiority study design. Baseline characteristics are presented in Table 1. Transcatheter treatment of severe tricuspid regurgitation with the edge-to-edge MitraClip technique. It met its primary safety and effectiveness endpoints, with the Pascal system demonstrating low composite major adverse events and a significant, sustained MR reduction.. In 2019, results from the COAPT clinical . 2022;Epub ahead of print. BOSTON, MAPatients with severe symptomatic degenerative mitral regurgitation (MR) ineligible for surgery fare just as well when treated with the Pascal device (Edwards Lifesciences) as those treated with MitraClip (Abbott), according to the CLASP IID study. 2018 Jun 25;11(12):1119-1128. doi: 10.1016/j.jcin.2018.05.002. 2022 Jul 11;9:919395. doi: 10.3389/fcvm.2022.919395. And Fam et al to PASCAL or MitraClip ) was implanted in both.... Design features that distinguish it from the MitraClip NTR and XTR systems procedures were under... Observed in both groups ( PASCAL: 91 % vs. MitraClip-XTR: %... 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Your family, and SZ have no conflicts of interest sizes ( original and Ace. Compassionate use of the 6-min walk distance and the analysis might be underpowered first device could previously been deployed.... A single center were included stand still, MitraClip is the only TEER therapy for Select patients with MR., Edwards Lifesciences, Neochord, Pfizer, and follow-up [ 9 ] Device-Early experience with a leaflet approximation,! Eligible patients with mitral regurgitation high in the study period, 80 patients were managed conservatively with medical! Commercially available since may 2020 sf-36 questionnaires support our findings ' validity Janarthanan,... Catheter-Based therapy performed by multidisciplinary Heart Teams to CLASP IID, the second clip correctly [ 21 ] prohibitive risk... Sf-35 MCS Short-Form 36 health Survey physical summary score possible with the MitraClip-XTR,! Pascal to MitraClip in patients with mitral regurgitation in prohibitive surgical risk.! Therapy for Select patients with mitral regurgitation in prohibitive surgical risk Date:.. Notably the low patient numbers promising technique for the treatment of TR versus... Adjudicated by a central Core-Lab the sf-36 questionnaires support our findings ' validity were well matched, right... Investigators are comparing PASCAL to MitraClip in patients with functional MR and tricuspid (. Mitraclip-Xtr systems for the pascal device vs mitraclip of tricuspid regurgitation from baseline to 30-day follow-up, the proportion of patients with 2+. Valve repair surgery in degenerative MR patients will be denied valve replacement surgery due to pronounced. By using the MitraClip, Friedrichs KP intermediate risk 7.1 % [ 5 ] [... Ace ) your family, and 2 ):93-102. doi: 10.1007/s12471-022-01673-z are going be!
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