Interventional procedure overview of transcatheter tricuspid valve annuloplasty for tricuspid regurgitation

Overall

The composite major adverse event rate at 30 days was 20% (12/61) in the single-arm study of 61 people (Nickenig, 2021). A composite end point of death, myocardial infarction, need for urgent cardiothoracic surgery or stroke at 30 days was reported in 7% (4/60) of people in the case series of 60 people (Körber, 2021).

Mortality

One person died from procedure-related renal failure on postoperative day 18 in the single-arm study of 61 people (Nickenig, 2021). Mortality was 17% (5/30) at 1 year and 27% (8/30) at 2 years follow up in the single-arm study of 30 people. Of the 8 deaths, 6 were non-cardiovascular deaths beyond 30 days after the procedure (Nickenig, 2021b). Mortality at 30 days was 3% (2/60) in the case series of 60 people; 1 person died in end of life care 15 days after the procedure and 1 person died 3 weeks after the procedure from COVID‑19 (Körber, 2021).

Myocardial infarction

Transient intraprocedural occlusion of the right coronary artery, which resolved spontaneously, was reported in 1 person in the single-arm study of 61 people (Nickenig, 2021). Myocardial infarction was reported in 1 person in the case series of 60 people (Körber, 2021).

Stroke

Stroke was reported in 1 person at 1 year and 2 people at 2 years follow up in the single-arm study of 30 people (Nickenig, 2021b).

Pericardial effusion or cardiac tamponade

Pericardial effusion needing intervention was reported in 1 person in the single-arm study of 61 people (Nickenig, 2021). Cardiac tamponade was reported in 3% (2/60) of people in the case series of 60 people (Körber, 2021) and in 1 person in the case series of 30 people (Davidson, 2021).

Coronary artery injury

Coronary artery injury needing intervention was reported in 7% (4/61) of people in the single-arm study of 61 people (Nickenig, 2021). Right coronary artery perforation was reported in 5% (3/60) of people in the case series of 60 people; 2 had conservative treatment. Right coronary artery stent implantation was reported in 12% (7/60) of people in the same study (Körber, 2021).

Arrhythmia and conduction disorders

Arrhythmia and conduction disorders needing permanent pacing were reported in 1 person in the single-arm study of 61 people (Nickenig, 2021). Conduction system disturbance was reported in 1 person at 1 year and 2 people at 2 years follow up in the single-arm study of 30 people. In the same study, ventricular arrhythmia was reported in 10% (3/30) of people (Nickenig, 2021b). Haemodynamically relevant arrhythmia was reported in 12% (7/60) of people within 30 days of the procedure in the case series of 60 people. A new pacemaker was needed in 3% (2/60) of people (Körber, 2021).

Renal complications

New need for renal replacement therapy was reported in 3% (2/61) of people in the single-arm study of 61 people (Nickenig, 2021).

Renal failure was reported in 1 person in the single-arm study of 30 people (Nickenig, 2021b). Acute renal failure within 30 days of the procedure was reported in 12% (7/60) of people in the case series of 60 people (Körber, 2021).

Access-site and vascular complications

Major access-site and vascular complications were reported in 7% (4/61) of people in the single-arm study of 61 people (Nickenig, 2021). Access-site-related bleeding was reported in 1 person in the case series of 60 people (Körber, 2021).

Severe bleeding was reported in 12% (7/61) of people in the single-arm study of 61 people. All 7 people were on anticoagulation or antiplatelet therapy for pre-existing atrial fibrillation or flutter (Nickenig, 2021). Bleeding complications (extensive, life-threatening, or fatal) were reported in 20% (6/30) of people at 1 year and 23% (7/30) of people at 2 years follow up in the single-arm study of 30 people (Nickenig, 2021b). Major, extensive or life-threatening bleeding was reported in 5% (3/60), 5% (3/60) and 2% (1/60) of people respectively in the case series of 60 people. Blood transfusion was reported in 20% (12/60) of people (Körber, 2021). Severe bleeding was reported in 23% (7/30) of people in the case series of 30 people; 2 were described as life-threatening, 1 was extensive and 4 were major (Davidson, 2021).

Reintervention

Device-related secondary intervention was reported in 1 person at 1 year and 2 people at 2 years follow up in the single-arm study of 30 people (Nickenig, 2021b). Urgent open-heart surgery was needed in 3% (2/60) of people in the case series of 60 people (Körber, 2021).

Anecdotal and theoretical adverse events

In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never happened).

For this procedure, professional experts listed the following anecdotal adverse events: (partial) detachment of the annuloplasty band, perforation of right atrium or ventricle, worsening of right heart failure, oesophageal injury, ventricular tachycardia, and stroke.