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Limited Clinial Application of MitraClip: a summary of the interim analysis and report sent to RIZIV

Updated: Jan 11, 2018

Introduction


On March 1st, 2016, a Limited Clinical Application (LCA) was initiated for “one or more implants and adjunctives for percutaneous repair of the coaptation of the mitral valve leaflets in patients with symptomatic severe mitral valve regurgitation at high or prohibitive risk for surgery”. This LCA was characterized by specific requirements for applying cardiac centers, their candidate patients and the devices used.


In brief, this LCA regulation granted temporary (5 years) partial material reimbursement to voluntary networks of a minimum of 3 B3 cardiac centers with a combined valve surgery volume of >600/year. This LCA restricted reimbursement of this novel technique to one implanting center per network, and a maximum yearly number of applications was calculated based on the volume of valve surgery in each network. The LCA further predefined rules for patient selection based on clinical and echocardiographic criteria in a heart team discussion. Finally, specific requirements for devices were defined.

The LCA equally implied an obligation to cardiac networks and their scientific working groups to monitor patient selection, implantation procedures and patient outcome. More specifically, the LCA regulation requested a yearly interim analysis of a limited dataset (deadline July 1st, yearly), as well as a more profound analysis to be completed before July 1st , 2020.

The present report includes the first analysis of the dataset 16 months after initiation of the LCA.


Data registration

Data from patients undergoing MitraClip implantation before March 1st 2016 was stored in a common Dropbox folder (MITRABEL). Since then, BWGIC engaged an independent Clinical Research Organization (CRO) LCC (Leuven coordinating center) to design an electronic database according to the requirements of RIZIV/INAMI.


Data analysis

The present analysis refers to MitraClip implantations in Belgium between March 1st, 2016 and June 12th, 2017. In this period, 102 patients were treated in networks defined by the LCA regulation. Moreover, 11 patients were treated in a center not fulfilling the criteria of the LCA. The actual number of MitraClip implantations (as of November 16th, 2017) was 80 procedures in 2016 and 103 in 2017. Most likely, at the end of the year, the number of performed cases will be inferior to the RIZIV/INAMI predefined quota (with partial reimbursement) (141 for 2017).

The following analysis will reflect minimal clinical and outcome data in the 102 patients treated in centers who entered the LCA.


Adverse events

For correct interpretation, the relative short term follow-up in most of the patients in this early analysis should be taken into consideration.

The following adverse events were reported in 102 patients treated since March 1st, 2016:

  • Cardiac death: 3

  • Non-cardiac death: 2

  • Surgical mitral valve reintervention: 3

  • Cardiac surgery for other reasons: 1

  • Rehospitalisation for heart failure: 9 (of which several in the same patient)

  • Partial clip detachment: 4

  • Severe bleeding: 1

These events are cumulative and not mutually exclusive.


Conclusion

The present report reflects early adoption and major outcomes/adverse events of percutaneous mitral valve interventions with the MitraClip device in the first 102 patients treated within the LCA 001. In this early experience, several factors may have contributed to the fact that MitraClip networks did not reach the number of allocated implantations: 1/ start-up of collaboration within networks is challenging and took some time; 2/ awareness for the technique is recently growing in referral centers; 3/ the significant investment to compensate the partial reimbursement of the device is a major financial burden for the implanting centers/networks; 4/ the lack of honorarium for these multidisciplinary and complex procedures, as well as for the requested multidisciplinary heart-team discussions is problematic.

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