Interventional procedure overview of transcatheter tricuspid valve leaflet repair for tricuspid regurgitation

Safety summary

Overall

Mortality (within 30 days of initial hospitalisation)

Mortality at 30 days was 4% (10/280) in the registry of 312 patients. The causes of death were sepsis (n=2), respiratory insufficiency (n=2) and progressive right ventricular failure (n=6; Taramasso, 2019b).

Mortality during the initial hospitalisation was reported in 3% (7/249) of patients and cardiovascular mortality was 2% (6/249) in the registry of 249 patients (Mehr, 2019).

Conversions to surgery

Conversion to surgery was reported in 1% (4/280) of patients in the registry of 312 patients. Two patients had emergency surgery and the other 2 had elective tricuspid surgery because of procedural failure (Taramasso, 2019b).

Conversion to open heart surgery was reported in 1 patient in the registry of 249 patients (Mehr, 2019).

Myocardial infarction

Acute myocardial infarctions needing right coronary artery stenting was reported in 1% (2/280) of patients in the registry of 312 patients (Taramasso, 2019b).

Myocardial infarction within 1 year of the procedure was reported in 1 patient in the single-arm study of 85 patients (Lurz, 2021).

The incidence of myocardial infarction was 0 per 100 person-years in patients who had TTVI (n=53) and 1.0 per 100 person-years (95% CI 0 to 5.4) in patients who had medical therapy alone (n=71) in the non-randomised comparative study of 124 patients (p=1.00; Cai, 2020).

Stroke

Stroke was reported in 1% (3/280) of patients in the registry of 312 patients (Taramasso, 2019b).

Ischaemic stroke during the hospital stay was reported in 1% (2/249) of patients in the registry of 249 patients. Both patients had concomitant mitral valve intervention (Mehr, 2019).

Stroke within 1 year of the procedure was reported in 1 patient in the single-arm study of 85 patients (Lurz, 2021).

The incidence of stroke was 0 per 100 person-years in patients who had TTVI (n=53) and 2.9 per 100 person-years in patients who had medical therapy alone (n=71; 95% CI 0.6 to 8.5) in the non-randomised comparative study of 124 patients (p=0.41; Cai, 2020).

Pericardial effusion or cardiac tamponade

Pericardial effusion was reported in 1 patient in the registry of 249 patients (Mehr, 2019).

Cardiac tamponade was reported in 1 patient who had surgical conversion in the case series of 19 patients (Asmarats, 2019).

Arrhythmia and conduction disorders

Ventricular arrhythmia was reported in 1 patient in the registry of 312 patients (Taramasso, 2019b).

New onset atrial fibrillation was reported in 1 patient in the single-arm study of 85 patients (Lurz, 2021).

Renal complications

Acute kidney injury was reported in 4% (9/249) of patients in the registry of 249 patients (Mehr, 2019).

New onset renal failure within 1 year of the procedure was reported in 1 patient in the single-arm study of 85 patients (Lurz, 2021).

The incidence of acute kidney injury was 14.1 per 100 person-years (95% CI 6.8 to 26.0) in patients who had TTVI (n=53) and 37.0 per 100 person-years (95% CI 26.2 to 50.8) in patients who had medical therapy alone (n=71) in the non-randomised comparative study of 124 patients (p=0.006). The incidence of new initiation of renal replacement therapy was 4.2 per 100 person-years (95% CI 0.8 to 12.4) in patients who had TTVI (n=53) and 3.9 per 100 person-years (95% CI 1.1 to 10.0) in patients who had medical therapy alone (n=71, p=1.00; Cai, 2020).

Bleeding

Major bleeding was reported in 2% (5/280) of patients in the registry of 312 patients (Taramasso, 2019b).

Bleeding was reported in 6% (15/249) of patients in the registry of 249 patients (Mehr, 2019).

Major bleeding was reported in 12% (10/84) of patients in the single-arm study of 85 patients (Lurz, 2021).

Major or life-threatening bleeding was reported in 11% (2/19) of patients in the case series of 19 patients. One bleed was caused by cardiac tamponade in a patient who had surgical conversion (Asmarats, 2019).

The incidence of gastrointestinal bleed was 4.2 per 100 person-years (95% CI 0.8 to 12.4) in patients who had TTVI (n=53) and 15.6 per 100 person-years (95% CI 8.9 to 25.3) in patients who had medical therapy alone (n=71) in the non-randomised comparative study of 124 patients (p=0.04; Cai, 2020).

Infection

Infection was reported in 5% (12/249) of patients in the registry of 249 patients. Further details were not reported (Mehr, 2019).

Respiratory failure

Respiratory failure was reported in 1% (2/280) of patients in the registry of 312 patients (Taramasso, 2019b).

Device detachment

Device detachment was reported in 1 patient in the registry of 312 patients (Taramasso, 2019b).

Single leaflet device attachment was reported in 8% (5/65) of patients in the single-arm study of 85 patients. No additional intervention was needed and there was no worsening of clinical symptoms (Lurz, 2021).

Other

Aortic prosthetic valve thrombosis was reported in 1 patient in the registry of 312 patients (Taramasso, 2019b).

A mean tricuspid gradient 5 mmHg or above was reported in 6% (4/64) of patients in the single-arm study of 85 patients (Lurz, 2021).

Thrombus on the device and pulmonary embolism were reported as a late outcome in 1 patient each in the case series of 19 patients (Asmarats, 2019).

A case report described a clip device being stuck and knotted because of the Chiari network. Additional clips were implanted successfully and tricuspid regurgitation was reduced (Miura, 2019).