Skip to main content
Download PDF
Download ePub

Transcatheter mitral valve implantation with Tendyne System Ten Years since the First In-Human Implant A systematic review

Journal of Cardiothoracic Surgery volume 18, Article number: 315 (2023) Cite this article

Abstract

Background

Transcatheter mitral valve replacement (TMVR) using the Tendyne™ valve is regarded as one of the most studied TMVR systems. The first human experience with the procedure was reported in 2013. The present study aims to systemically revise the published literature to document the global experience with TMVR using the Tendyne™ valve.

Methods

The present review was conducted in line with the PRISMA statement on systematic reviews. Database included in the search process were Scopus, Web of Science and Pubmed. Search was processed using multiple keywords combinations and was adjusted to English literature only.

Results

We included 26 articles in the final analysis reporting data from 319 patients. Patients recruited by the included studies comprised 192 males (60.2%) and 127 females (39.8%). In the studied patients, mitral annular calcification (MAC) was reported in 107 patients (33.5%). Preoperatively, MR grades 1,2 and 3–4 were reported in 3,5 and 307 patients respectively. Postoperatively, MR grades 1, 2 and 4 were reported in only 12, 3 and 1 patients respectively. Technical success was achieved in 309 patients (96.9%). Follow up durations widely varied among different studies from just days before discharge to 6 years. At the end of follow up, 79 patients died (24.8%) including 52 patients (16.3%) due to cardiovascular causes.

Conclusions

Management of mitral valve disease using the Tendyne system appears to be a promising minimally invasive option for many high-risk patients with accepted procedural feasibility and safety profile.

Peer Review reports

Introduction

Clinically significant mitral regurgitation (MR) is the most common valvular heart disease. The burden of the condition dramatically increases with older age [1]. Until recently, surgical repair and replacement were the standard therapeutic strategies. Considering the surgical high-risk profile of many patients, they were left without effective treatment options [2].

Over the past decade, technological advances continued to add multiple devices for transcatheter mitral valve repair and replacement with only few gained approvals by the healthcare authorities in Europe and the United States [3]. However, in view of the recent experience with these devices and the lack of long-term follow up studies, integrating their use into the standard treatment algorithms remains challenging [4].

Transcatheter mitral valve replacement (TMVR) using the Tendyne™ valve (Abbott Vascular, CA, USA) is regarded as one of the most studied TMVR systems. It’s a self-expanding prothesis with a double-frame design anatomically suited for the mitral annulus [5]. The first human experience with the procedure was reported in 2013 [6]. More recently, the Tendyne Global Feasibility Study has provided initial evidence of the procedural safety and efficacy over 2 years [7].

In Europe, the device has gained the CE mark [3]. In the United States, the ongoing randomized study “The Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (NCT03433274). is expected to test the advantage -if any- of Tendyne system over the standard conventional surgery [5].

Preoperative planning and patient selection

Appropriate selection of patients suitable for Tendyne valve implantation requires multimodal cardiac imaging using transthoracic and transesophageal echocardiography and contrast-enhanced gated computed tomography. Imaging aims to evaluate the function and morphology of the mitral valve (MV) with special emphasis on severity of mitral annular calcification (MAC), angle of aortic mitral curtain and left ventricular outflow (LVOT) size [5, 8].

The surgical technique

The Tendyne transcatheter valve is a self-expanding, fully retrievable and repositionable porcine valve. It’s composed of an inner circular stent frame and outer D-shaped stent frame. Both frames are made of nickel titanium alloy. The inner frame has only one size and has three leaflets. The outer frame has multiple sizes and has fabric cuff which sits at the annulus. The valve is anchored to the left ventricular apex by a tethered locking pad under guidance of fluoroscopy and transesophageal echocardiography under general anesthesia using the transapical approach through left minithoracotomy [8, 9].

The present study aims to systemically revise the published literature to document the global experience with TMVR using the Tendyne™ valve (Abbott Vascular, CA, USA).

Methods

Search methodology

The present review was conducted in line with the PRISMA statement on systematic reviews. Database included in the search process were Scopus, Web of Science and Pubmed. Search was processed using multiple combinations of the keywords (mitral valve, mitral regurgitation, transcatheter mitral valve, Tendyne system, Tendyne valve). Search was adjusted to include full-text journal articles published in English. Clinical studies of all types (Prospective, retrospective, comparative, etc.), case series and case reports were included. Retrieved records were published up to September, 2023. Selection criteria and search strategy and process were agreed by all co-authors.

Inclusion criteria

All articles of all types published in English with at least essential preoperative characteristics and early postoperative course were included in the study.

Exclusion criteria

Articles reporting Tendyne system data mixed with other TMVR systems or reporting data of patients included in other studies were excluded from final analysis.

Data extraction and presentation

Data extracted from selected articles included type of article, country of origin, number and sex of patients, baseline Society of Thoracic Surgeons predicted risk of mortality (STS-PROM), left ventricular ejection fraction % (LVEF), presence of mitral annular calcification (MAC), degree of preoperative and postoperative mitral regurgitation at the last follow up, previous implants or procedures, technical success, other technical notes, duration of follow up, early (30-day) and later complications and cardiovascular and all-cause mortality. Outcome parameters were reported according to recommendations of the Mitral Valve Academic Research Consortium [10]. Obtained data were presented as number and percent, mean and standard deviation or median and interquartile range.

Results

Characteristics of the included studies

We could identify 269 records through search of the three databases using different keywords combinations. After thorough assessment of these records, we selected 49 articles for further assessment of full text if required. Finally, we included 26 articles in the final analysis reporting data from 319 patients (Fig. 1). Included studies types, country of origin and number of participants are listed in Table 1.

Fig. 1
figure 1

Study flow diagram

Full size image
Table 1 Characteristics of included studies (N = 26)
Full size table

Baseline characteristics of the studied patients

Patients recruited by the included studies comprised 192 males (60.2%) and 127 females (39.8%). Patients’ age, STS-PROM and LVEF % are shown in Table 2.

Table 2 Baseline clinical characteristics of the included patients (N = 319)
Full size table

Mitral valve characteristics in the included patients

In the studied patients, mitral annular calcification (MAC) was reported in 107 patients (33.5%). Preoperatively, MR grades 1,2 and 3–4 were reported in 3,5 and 307 patients respectively. Postoperatively, MR grades 1, 2 and 4 were reported in only 12, 3 and 1 patients respectively (Table 3).

Table 3 Mitral valve characteristics in the included patients (N = 319)
Full size table

Technical parameters in the included patients

Technical success was achieved in 309 patients (96.9%). Four patients were previously submitted to failed Mitraclip insertion. Other technical parameters are shown in Table 4.

Table 4 Technical parameters in the included patients (n = 319)
Full size table

Complications and mortality in the included patients

Follow up durations widely varied among different studies from just days before discharge to 6 years. At the end of follow up, 79 patients died (24.8%) including 52 patients (16.3%) due to cardiovascular causes. The most commonly reported complications included PVL, LOVTO and endocarditis (Table 5).

Table 5 Complications and mortality in the included patients (n = 319)
Full size table

Discussion

Ten years after the first in-human implant of Tendyne system for management of MR, the present work sought to revise the published literature to evaluate how the technique evolved in terms of clinical value and technical development since its introduction. We included almost all the published articles whatever their types not to miss any piece of real-world experience with such a new devise.

As shown by our findings, the technology has been considered in more countries through Europe and North America. However, no reports from the rest of the world could be found to date. The barriers against wider use of such devices should be investigated. Probably, appropriate integration of minimally invasive devices in management of mitral valve disease into the standard treatment guidelines will encourage more surgeons to advocate their use.

In this review, we could easily recognize the promising potential of the Tendyne system in management of MR. After intervention was applied, only 1 patient was left with grade 4 MR while 10 and 2 patients had grade 1 and 2 MR respectively. These findings are limited by the short course of follow up. However, studies with the longest reported follow up duration including that of Duncan et al. [17], Gossl et al., [18], Muller et al., [7], Taramasso et al., [30], Wienemann et al., [33] and Wilde et al., [35] with a follow up duration ranging from almost one year up to six years showed also impressive results.

It’s clear that all patients included in this systematic review are of older age and most of them had deteriorated general condition and ventricular function and are unfit for surgery or other minimally invasive techniques. The availability of such minimally invasive procedure in this high-risk population adds a substantial value to treatment options. Notably, many patients included in our analysis were successfully submitted to Tendyne valve implantation after failed Mitraclip insertion [13, 25, 29, 32]. This highlights the value of the technology in complicated scenarios with limited options.

Remarkably, about one third of the patients evaluated in the present review had various degrees of MAC and almost all patients in the studies of Gossl et al. [18] and Wienemann et al. [33] had MAC. Apart from one patient, technical success was achieved and MR was resolved in all patients in both studies. After approximately 1 year of follow up, cardiovascular mortality was observed in 20.0% and 13.0% respectively.

Interestingly, the technology could also successfully in particularly challenging situations. Damian et al., [15] reported their experience with double aortic and mitral valves replacement. Also, Pozzoli et al., [25] elegantly documented their work with first case of valve-in-ring implanting a Tendyne in Cardioband.

Technically, the procedure showed remarkable procedural success rates and by time, surgeons could add many technical enhancements. In some situations, Laceration of the Anterior Mitral leaflet to Prevent Outflow ObtructioN (LAMPOON) procedure were done to improve the outflow tract [12]. In other cases, pre-dilatation with balloon valvuloplasty was found to be useful [30, 28] and neo-left ventricular outflow tract modification with alcohol septal ablation was also applied [31].

Paravalvular leak is considered the most common postoperative complications as noted by our review and in some instance may be so significant to induce systemic reactions [7, 18, 11]. In many cases, valve re-tensioning could successfully resolve the problem. Other reported complications included left ventricular outflow tract obstruction, hemolysis and endocarditis.

Generally, the Tendyne valve appears to have high rate of technical success and low rate of postoperative significant residual MR. However, similar to other TMVR devices, its use may be associated with relatively high rate of perioperative complications. In comparison with the transcatheter MV repair approaches e.g. MitraClip, the all-cause mortality and rehospitalization rate due to heart failure may be higher with TMVR devices [36].

In conclusion, management of mitral valve disease using the Tendyne system appears as a promising minimally invasive option for many high-risk patients with accepted procedural feasibility and safety profile. These conclusions may be limited by the short follow up period and lack of randomized controlled trials.

Data Availability

The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.

References

  1. Koell B, Kalbacher D, Lubos E. Current devices and interventions in mitral regurgitation. Herz. 2021;46(5):419–28.

    Article  PubMed  Google Scholar 

  2. McInerney A, Marroquin-Donday L, Tirado-Conte G, Hennessey B, Espejo C, Pozo E, et al. Transcatheter treatment of mitral regurgitation. J Clin Med. 2022;11(10):2921.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Khatib D, Neuburger PJ, Pan S, Rong LQ. Transcatheter mitral valve interventions for mitral regurgitation: a review of mitral annuloplasty, valve replacement, and Chordal Repair devices. J Cardiothorac Vasc Anesth. 2022;36(10):3887–903.

    Article  PubMed  Google Scholar 

  4. Basman C, Johnson J, Pirelli L, Patel NC, Reimers C, Singh VP et al. Mitral regurgitation in the high-risk patient: integrating an Expanding Armamentarium of Transcatheter devices into the treatment algorithm. Cardiol Rev 2022 Nov-Dec 01;30(6):299–307.

  5. Niikura H, Gössl M, Sorajja P. Transcatheter mitral valve replacement with Tendyne. Interv Cardiol Clin. 2019;8(3):295–300.

    PubMed  Google Scholar 

  6. Lutter G, Lozonschi L, Ebner A, Gallo S, Marin y Kall C, Missov E, et al. First-in-human off-pump transcatheter mitral valve replacement. JACC Cardiovasc Interv. 2014;7(9):1077–8.

    Article  PubMed  Google Scholar 

  7. Muller DWM, Sorajja P, Duncan A, Bethea B, Dahle G, Grayburn P, et al. 2-Year outcomes of transcatheter mitral valve replacement in patients with severe symptomatic mitral regurgitation. J Am Coll Cardiol. 2021;78(19):1847–59.

    Article  PubMed  Google Scholar 

  8. Patel JS, Kapadia SR. The Tendyne transcatheter mitral valve replacement system for the treatment of mitral regurgitation. Future Cardiol. 2019;15(3):139–43.

    Article  CAS  PubMed  Google Scholar 

  9. Aoun J, Reardon MJ, Goel SS. Transcatheter mitral valve replacement: an update. Curr Opin Cardiol. 2021;36(4):384–9.

    Article  PubMed  Google Scholar 

  10. Stone GW, Adams DH, Abraham WT, Kappetein AP, Généreux P, Vranckx P, Mitral Valve Academic Research Consortium (MVARC), et al. Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: a consensus document from the Mitral Valve Academic Research Consortium. Eur Heart J. 2015;36(29):1878–91.

    Article  CAS  PubMed  Google Scholar 

  11. Aktuerk D, Jansz P, Shaw M, Muller DWM. Successful repositioning of apically tethered transcatheter mitral valve replacement in the off-bypass, beating heart. Catheter Cardiovasc Interv. 2020;95(1):E37–E9.

    Article  PubMed  Google Scholar 

  12. Alarcon R, Barreiro-Perez M, Estevez-Loureiro R. Tendyne valve facilitated by antegrade anterior mitral laceration. Rev Esp Cardiol. 2022;75(5):440–1.

    Article  PubMed  Google Scholar 

  13. Carnicer JC, Casado PM, Nombela-Franco L, Alcazar MC, Quevedo PJ, Castellanos LCM. Transcatheter mitral valve replacement with Tendyne: first experience in Spain. Rev Esp Cardiol. 2021;74(10):881–2.

    Google Scholar 

  14. Cerillo AG, Paduvakis J, Petrini F, Stefano P. Late displacement and ineffective retensioning of a transapical transcatheter mitral prosthesis. JTCVS Tech. 2023;20:55–7.

    Article  PubMed  PubMed Central  Google Scholar 

  15. Damian I, Kellermair J, Grund M, Zierer A. First in Human: transcatheter, Transapical double valve replacement. Ann Thorac Surg. 2021;112(3):968–9.

    Article  PubMed  Google Scholar 

  16. Damian I, Zierer A, Grund M, Kellermair J, Transcatheter. Transapical mitral valve replacement after mitral valve annuloplasty. Ann Thorac Surg. 2022;113(6):e433–e5.

    Article  PubMed  Google Scholar 

  17. Duncan A, Quarto C. 6-Year outcomes of First-In-Man Experience with Tendyne Transcatheter mitral valve replacement: a single Center experience. JACC Cardiovasc Interv. 2021;14(20):2304–6.

    Article  PubMed  Google Scholar 

  18. Gossl M, Thourani V, Babaliaros V, Conradi L, Chehab B, Dumonteil N, et al. Early outcomes of transcatheter mitral valve replacement with the Tendyne system in severe mitral annular calcification. EuroIntervention. 2022;17(18):1523–31.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Grinberg D, Pozzi M, Bernard C, Obadia JF. A tensed Tendyne. Eur J Cardiothorac Surg. 2020;58(3):651–3.

    Article  PubMed  Google Scholar 

  20. Hosadurg N, Patel TR, Villines TC. Hypoattenuated Leaflet Thickening in a Tendyne Bioprosthetic Mitral Valve. Jacc-Cardiovascular Interventions. 2022;15(17):E193–E4.

    Article  PubMed  PubMed Central  Google Scholar 

  21. Norgren P, Dalén M, Feldt K, Rück A, Ax M, Svenarud P, et al. Left ventricular outflow tract obstruction following transcatheter mitral valve replacement resolved by Chordal Rupture. JACC Case Rep. 2021;3(17):1828–35.

    Article  PubMed  PubMed Central  Google Scholar 

  22. Nucera M, Miazza J, Praz F, Kaiser C, Siepe M, Reineke D et al. Transapical Transcatheter Mitral Valve Implantation with the Tendyne Valve: The Swiss Experience. Thorac Cardiovasc Surg. 2023 Jun 16. https://doi.org/10.1055/s-0043-1769099. Epub ahead of print. PMID: 37327913.

  23. Piperata A, Pernot M, Issa N, Ternacle J. Unusual postoperative Course after Tendyne Implantation. Circulation-Cardiovascular Imaging. 2022;15(9):698–700.

    Article  Google Scholar 

  24. Polizzi V, Pergolini A, Zampi G, Cacioli G, Pontillo D, Musumeci F. Transcatheter mitral valve replacement with TendyneTMDevice: overview of three-dimensional echocardiography monitoring. Kardiologia Polska. 2021;79(10):1161–2.

    Article  PubMed  Google Scholar 

  25. Pozzoli A, Gavazzoni M, Maisano F, Taramasso M. Transcathetermitral valve replacement after transcatheter direct annuloplasty with Cardioband. Eur Heart J. 2020;41(38):3765.

    Article  PubMed  Google Scholar 

  26. Puehler T, Saad M, Haneya A, Frank D, Lutter G. Rendezvous of CoreValve Skirt with Tendyne Crown. Jacc-Cardiovascular Interventions. 2021;14(18):2073–4.

    Article  PubMed  Google Scholar 

  27. Ruge H, Xhepa E, Joner M, König C, Ried T, Imeri E, et al. First-in-man simultaneous aortic and mitral valve transcatheter implantation using patient-customized prostheses. JACC: Case Reports. 2021;3(4):653–7.

    PubMed  PubMed Central  Google Scholar 

  28. Sorajja P, Gössl M, Bae R, Tindell L, Lesser JR, Askew J, et al. Severe mitral annular calcification: first experience with transcatheter therapy using a dedicated mitral prosthesis. JACC: Cardiovasc Interventions. 2017;10(11):1178–9.

    Google Scholar 

  29. Sorajja P, Bae R, Gossl M, Askew J, Jappe K, Olson S, et al. Complementary transcatheter therapy for mitral regurgitation. J Am Coll Cardiol. 2019;73(9):1103–4.

    Article  PubMed  Google Scholar 

  30. Taramasso M, Sorajja P, Dahle G, Dumonteil N, Schäfer L, Modine T, et al. Transapical transcatheter mitral valve implantation in patients with prior aortic valve replacement: a feasibility report. EuroIntervention. 2021;17(3):257–9.

    Article  PubMed  PubMed Central  Google Scholar 

  31. Ukaigwe A, Gossl M, Cavalcante J, Olson S, Sorajja P. (a). Neo-Left Ventricular Outflow Tract Modification With Alcohol Septal Ablation Before Tendyne Transcatheter Mitral Valve Replacement. Jacc-Cardiovascular Interventions. 2020;13(17):2078-80.

  32. Ukaigwe AC, Sorajja P, Hashimoto G, Lopes B, Gossl M. (b). Challenges of Left Atrial Appendage Occlusion Using a Watchman After Transcatheter Mitral Valve Implantation With a Tendyne. Jacc-Cardiovascular Interventions. 2020;13(14):1720-2.

  33. Wienemann H, Mauri V, Ochs L, Korber MI, Eghbalzadeh K, Iliadis C et al. Contemporary treatment of mitral valve Disease with transcatheter mitral valve implantation. Clinical Research in Cardiology.

  34. Wild MG, Kreidel F, Hell MM, Praz F, Mach M, Adam M, et al. Transapical mitral valve implantation for treatment of symptomatic mitral valve Disease: a real-world multicentre experience. Eur J Heart Fail. 2022;24(5):899–907.

    Article  CAS  PubMed  Google Scholar 

  35. Wilde N, Tenaka T, Vij V, Sugiura A, Sudo M, Eicheler E et al. Characteristics and outcomes of patients undergoing transcatheter mitral valve replacement with the Tendyne system. Clin Res Cardiol. 2023.

  36. Del Val D, Ferreira-Neto AN, Wintzer-Wehekind J, Dagenais F, Paradis JM, Bernier M, et al. Early experience with transcatheter mitral valve replacement: a systematic review. J Am Heart Assoc. 2019;8(17):e013332.

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgements

None.

Funding

Not applicable.

Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB).

Author information

Authors and Affiliations

  1. Department of Cardiothoracic Surgery, Ain Shams University, Cairo, Egypt

    Ahmed Ahmed

  2. Dubai Hospital, Dubai, UAE

    Tarek A. Abdel Aziz, Mohannad M. R. AlAsaad & Motaz Majthoob

  3. Department of Cardiothoracic Surgery, Faculty of Medicine, Helwan University, Cairo, Egypt

    Ahmed Toema

Authors
  1. Ahmed Ahmed
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Tarek A. Abdel Aziz
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Mohannad M. R. AlAsaad
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Motaz Majthoob
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Ahmed Toema
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

AA, TA, MA, MM, AT equally contributed to data acquisition and manuscript writing. AA, TA, MA, MM, AT revised tables and figures. All authors reviewed the manuscript.

Corresponding author

Correspondence to Ahmed Ahmed.

Ethics declarations

Competing interests

The authors declare no competing interests.

Consent for publication

Not applicable.

All methods were performed in accordance with relevant guidelines and regulations.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

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. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Ahmed, A., Aziz, T.A.A., AlAsaad, M.M.R. et al. Transcatheter mitral valve implantation with Tendyne System Ten Years since the First In-Human Implant A systematic review. J Cardiothorac Surg 18, 315 (2023). https://doi.org/10.1186/s13019-023-02446-4

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1186/s13019-023-02446-4

Keywords

Journal of Cardiothoracic Surgery

ISSN: 1749-8090

Contact us