Clinical Investigation
Echocardiography and Percutaneous Mitral Valve Interventions
Systematic Fluoroscopic-Echocardiographic Fusion Imaging Protocol for Transcatheter Edge-to-Edge Mitral Valve Repair Intraprocedural Monitoring

https://doi.org/10.1016/j.echo.2021.01.010Get rights and content

Highlights

  • First application of a standardized fluoroscopic-echocardiographic FI protocol for TMVr.

  • FI may be particularly useful for challenging TSP, navigation in the left atrium and axial alignment.

  • FI compared to standard intraprocedural imaging reduces fluoroscopy time.

  • FI improves procedural results in a population with high prevalence of complex mitral anatomies.

Background

Whether fluoroscopic-echocardiographic fusion imaging (FI) might offer added value for intraprocedural guidance during transcatheter edge-to-edge mitral valve repair is yet unknown, and few data exist regarding the safety and feasibility of this novel technology.

Methods

The aim of this single-center study was to test and validate a FI protocol for intraprocedural monitoring of transcatheter edge-to-edge mitral valve repair and assess its clinical usefulness. Eighty patients underwent MitraClip implantation using FI guidance (FI+) for either degenerative (35%) or functional (65%) mitral regurgitation and were compared with the last 80 patients before FI introduction, treated using conventional echocardiography and fluoroscopic monitoring (FI−).

Results

The number of patients treated for functional and degenerative mitral regurgitation was similar between the FI+ and FI− groups, as well as the number of devices implanted (1.51 ± 0.5 vs 1.58 ± 0.6, P = .46). The prevalence of complex mitral anatomy for percutaneous repair was high (32.5%, up to 39.2% in the hybrid arm). Fluoroscopy time was significantly lower in FI+ patients (37.3 ± 14.6 vs 48.3 ± 28.3 min, P = .003), but not kerma area product (91.5 ± 74.1 vs 108.8 ± 105.0 Gy · cm2, P = .23) or procedural time (92.2 ± 36.1 vs 103.1 ± 42.7 min, P = .086). After adjusting for confounding factors (MitraClip XT device and complex anatomy), FI reduced fluoroscopy time (coefficient = −10.4 min; 95% CI, −18.03 to −2.82; P = .007) and improved procedural success at the end of the procedure (odds ratio, 2.87; 95% CI, 1.00 to 8.24; P = .049) and discharge (odds ratio, 2.24; 95% CI, 1.04 to 4.80; P = .039). Rates of periprocedural complications were similar in both groups (8.9% vs 13.0%, P = .40).

Conclusions

The authors describe the systematic use of an FI protocol for intraprocedural guidance during transcatheter edge-to-edge mitral valve repair, demonstrating a reduction in fluoroscopy time and an improvement in procedural success in a population with a high prevalence of challenging mitral anatomy for percutaneous repair.

Section snippets

Study Design and End Points

We included all consecutive patients who underwent TMVr with the MitraClip (Abbot Vascular, Santa Clara, CA) and the EchoNavigator system (Philips Medical Systems, Best, the Netherlands) in whom FI was used for procedural guidance (FI+), from October 2016 to July 2018 (22 months). We compared them with the last consecutive patients who underwent the procedure immediately before the introduction of FI in our department (FI−), from January 2015 to September 2016 (21 months).

The primary end point

Study Population

The study included 160 consecutive patients (mean age, 75 ± 9 years; 64.4% men): the first 80 patients (50%) were treated with conventional intraprocedural monitoring (FI−), and the last 80 (50%) were treated using FI for procedural guidance (FI+). All patients in the FI− group were treated with the MitraClip NT device, while the MitraClip XT device was used in 15 patients of the FI+ group and the MitraClip NT in the remaining 65.

Baseline clinical characteristics and echocardiographic data were

Discussion

This is among the first studies of patients treated with TMVr using FI for intraprocedural monitoring.

We showed that the use of FI (1) reduces fluoroscopy time and (2) increases procedural success in a population with a high prevalence of challenging anatomies for percutaneous repair.

Most baseline clinical and echocardiographic characteristics were very similar between the two consecutive groups, allowing direct comparison between FI− and FI+ patients.

The impact of the newer MitraClip XT device

Conclusion

In our study, the use of FI during TMVr was feasible and safe. The application of our standardized protocol was independently associated with a reduction in fluoroscopy time and improved procedural success in a population with a high prevalence of challenging anatomies for percutaneous mitral repair.

References (22)

  • R.S. von Bardeleben et al.

    Incidence and in-hospital safety outcomes of patients undergoing percutaneous mitral valve edge-to-edge repair using MitraClip: five-year German national patient sample including 13,575 implants

    EuroIntervention

    (2019)
  • Conflicts of Interest: None.

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