Clin Res Cardiol (2023). https://doi.org/10.1007/s00392-023-02180-w

Bleeding complications following percutaneous tricuspid valve repair with the Cardioband
T. Gietzen1, J. L. Althoff2, L. Ochs3, M. Gercek4, J. Von Stein1, C. Iliadis1, V. Rudolph4, S. Baldus3, R. Pfister1, M. I. Körber1
1Klinik III für Innere Medizin, Herzzentrum der Universität zu Köln, Köln; 2Klinik III für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin, Universitätsklinikum Köln, Köln; 3Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin, Herzzentrum der Universität zu Köln, Köln; 4Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen;
Introduction

Bleeding is the most common complication after percutaneous repair of tricuspid regurgitation. Direct annuloplasty is the more complex procedure compared to edge-to-edge repair, but it is unclear whether this impacts bleeding risk and data specifying these incidences is still lacking. 

Methods and results

Performing a bi-centre retrospective analysis including all consecutive patients undergoing percutaneous tricuspid valve repair with the Cardioband device between 2018 and 2022 at two German high volume institutions (Heart Center Cologne and Bad Oeynhausen) we examined the incidence and impact of bleeding complications defined according to the MVARC endpoint definition. 154 Patients were included in the final analysis.  

The overall incidence of MVARC bleeding was 18,8 % (n=29), major MVARC bleeding (hemoglobin drop ≥3g/dl) occurred in 7,1% (n=11). A hemoglobin drop of ≥4g/dl occurred in 7 cases (4,5%). 4 patients suffered from a life-threatening bleeding complication (2,6%). Bleeding complications are listed in table 1.

The mean drop in hemoglobin overall was 2,2 g/dl ± 1,1 (0,2 - 8,6 g/dl) per patient. Transfusion of packed red blood cells was given in 17 of all procedures (11,0%) and 15 patients (9,7%) required an intervention to stop bleeding. Bleeding locations are shown in figure 1.

Baseline hemoglobin level was 11,9 g/dl ± 2,0. During follow up, mean hemoglobin level recovered within 30 days after intervention to 11,6 g/dl (± 2,4) and within three months to 11,9 g/dl (±  2,6). There was no bleeding adjudicated as being a proximate cause of death in all 154 patients who underwent percutaneous tricuspid valve repair. The presence of an MVARC bleeding was not associated with a statistical significant increased overall mortality during follow up (mean 271 days), while numerically 17.2% of patients with bleeding had died versus 9.6% of patients without bleeding complications (p=0,23, figure 2). 

Conclusion

The presented data suggest a relevant incidence of bleeding complications following percutaneous tricuspid repair using Cardioband device. It is of note that bleeding of the femoral access site, pericardial hemorrhage and the esophagus are the most common localizations, which need explicit attention in periprocedural management.

None of the less there was no significant impact of periinterventional bleeding complications to overall survival.

Table 1 Bleeding complications after implantation of Cardioband

Event

Patients 

n=154

MVARC bleeding

29 (18.8)

Major bleeding

11 (7.1)

Extensive bleeding

7 (4.5)

Life-threatening bleeding

4 (2.6)

Lethal bleeding

0 (0.0)

Bleeding requiring intervention

15 (9.7)

Transfusion of red blood cells

17 (11.0)

Data presented in %

 



https://dgk.org/kongress_programme/jt2023/aP498.html