Baseline and intraoperative characteristics
| Randomised to SPVR (n=8) | Randomised to IPVR (n=11) | Overall (n=19) | ||
| Baseline characteristics | ||||
| Age at randomisation (years) | 29.7 (21.3, 36.2) | 23.6 (14.4, 43.7) | 25.8 (18.0, 39.3) | |
| Sex | Male | 6/8 (75.0%) | 5/11 (45.5%) | 11/19 (57.9%) |
| Body Mass Index | 26.7 (7.2) | 22.6 (4.7) | 24.3 (6.0) | |
| NYHA | I | 3/8 (37.5%) | 2/11 (18.2%) | 5/19 (26.3%) |
| II | 3/8 (37.5%) | 7/11 (63.6%) | 10/19 (52.6%) | |
| III | 2/8 (25.0%) | 2/11 (18.2%) | 4/19 (21.1%) | |
| Heart rhythm | Sinus rhythm | 6/8 (75.0%) | 10/11 (90.9%) | 16/19 (84.2%) |
| Heart block | 1/8 (12.5%) | 0/11 (0.0%) | 1/19 (5.3%) | |
| Atrial fibrillation/flutter | 0/8 (0.0%) | 1/11 (9.1%) | 1/19 (5.3%) | |
| Sinus Bradycardia | 1/8 (12.5%) | 0/11 (0.0%) | 1/19 (5.3%) | |
| Bloods | ||||
| Haemoglobin (g/L) | 146.6 (10.6) | 138.4 (12.1) | 141.8 (11.9) | |
| Platelets (x109/L) | 251.0 (51.4) | 256.8 (77.7) | 254.4 (66.2) | |
| Creatinine (µmol/L) | 80.5 (12.7) | 71.7 (20.5) | 75.4 (17.8) | |
| Cardiac condition | ||||
| PA/IVS | 1/8 (12.5%) | 0/11 (0.0%) | 1/19 (5.3%) | |
| DORV | 0/8 (0.0%) | 2/11 (18.2%) | 2/19 (10.5%) | |
| PA/VSD | 1/8 (12.5%) | 0/11 (0.0%) | 1/19 (5.3%) | |
| Pulmonary stenosis | 2/8 (25.0%) | 2/11 (18.2%) | 4/19 (21.1%) | |
| Tetralogy of fallot | 4/8 (50.0%) | 7/11 (63.6%) | 11/19 (57.9%) | |
| Other* | 1/8 (12.5%) | 2/11 (18.2%) | 3/19 (15.8%) | |
| O2 saturations (%) | 98.9 (1.4) | 98.1 (1.6) | 98.4 (1.5) | |
| Medical history | ||||
| Chronic pulmonary disease | 0/8 (0.0%) | 1/11 (9.1%) | 1/19 (5.3%) | |
| Previous cardiac surgery | 8/8 (100.0%) | 10/11 (90.9%) | 18/19 (94.7%) | |
| Family history (cardiac) | 4/8 (50.0%) | 1/11 (9.1%) | 5/19 (26.3%) | |
| Pulmonary hypertension | 0/8 (0.0%) | 1/11 (9.1%) | 1/19 (5.3%) | |
| Neurological dysfunction | 0/8 (0.0%) | 0/11 (0.0%) | 0/19 (0.0%) | |
| Renal dysfunction | 1/8 (12.5%) | 0/11 (0.0%) | 1/19 (5.3%) | |
| Smoking | No | 6/8 (75.0%) | 10/11 (90.9%) | 16/19 (84.2%) |
| Ex-smoker (>1 month) | 0/8 (0.0%) | 1/11 (9.1%) | 1/19 (5.3%) | |
| Yes | 2/8 (25.0%) | 0/11 (0.0%) | 2/19 (10.5%) | |
| Drugs on admission | ||||
| Heparin/clexane† | 0/8 (0.0%) | 0/7 (0.0%) | 0/15 (0.0%) | |
| Antiarrhythmic† | 0/8 (0.0%) | 0/7 (0.0%) | 0/15 (0.0%) | |
| Diuretics† | 0/8 (0.0%) | 1/7 (14.3%) | 1/15 (6.7%) | |
| Amiodarone† | 0/6 (0.0%) | 0/7 (0.0%) | 0/13 (0.0%) | |
| PPIs† | 0/8 (0.0%) | 0/7 (0.0%) | 0/15 (0.0%) | |
| Aspirin | 0/8 (0.0%) | 0/11 (0.0%) | 0/19 (0.0%) | |
| Warfarin | 1/8 (12.5%) | 1/11 (9.1%) | 2/19 (10.5%) | |
| ACE inhibitors | 2/8 (25.0%) | 1/11 (9.1%) | 3/19 (15.8%) | |
| Angiotensin 11 blockers | 0/8 (0.0%) | 1/11 (9.1%) | 1/19 (5.3%) | |
| Sildinafil | 0/8 (0.0%) | 0/11 (0.0%) | 0/19 (0.0%) | |
| Other‡ | 5/8 (62.5%) | 3/11 (27.3%) | 8/19 (42.1%) | |
| Preop echocardiographic assessment | ||||
| LV function | Good | 4/8 (50.0%) | 10/11 (90.9%) | 14/19 (73.7%) |
| Mildly impaired | 4/8 (50.0%) | 1/11 (9.1%) | 5/19 (26.3%) | |
| RV function | Good | 5/8 (62.5%) | 8/11 (72.7%) | 13/19 (68.4%) |
| Mildly impaired | 1/8 (12.5%) | 3/11 (27.3%) | 4/19 (21.1%) | |
| Moderately impaired | 2/8 (25.0%) | 0/11 (0.0%) | 2/19 (10.5%) | |
| Intraoperative characteristics | ||||
| Bypass data | ||||
| Bypass required§ | 8/8 (100.0%) | 6/11 (54.5%) | 14/19 (73.7%) | |
| If yes: myocardial protection | Blood | 5/7 (71.4%) | 2/6 (33.3%) | 7/13 (53.8%) |
| None | 2/7 (28.6%) | 4/6 (66.7%) | 6/13 (46.2%) | |
| Inotropes/vasodilators (intraoperative) | ||||
| Any intraoperative inotropes/vasodilators¶ | 4/8 (50.0%) | 5/11 (45.5%) | 9/19 (47.4%) | |
| Operative details | ||||
| Main pulmonary artery modified | Plicated | 2/8 (25.0%) | 4/11 (36.4%) | 6/19 (31.6%) |
| Enlarged | 2/8 (25.0%) | 1/11 (9.1%) | 3/19 (15.8%) | |
| No change | 4/8 (50.0%) | 6/11 (54.5%) | 10/19 (52.6%) | |
Data are presented as median (IQR), mean (SD) or n (%).
*Other cardiac conditions: transposition of the great arteries VSD (n=1: SPVR), primary pulmonary regurgitation (n=1: IPVR), mild A.R. Pulmonary regurgitation acquired (n=1: IPVR).
†N/A for paediatric patients (n=4).
‡Levothyroxine Novorapid Lantus (n=1: SPVR), Metformin, Disoprolol, Sitagliptin and Glimepiricle (n=1: SPVR), Co-Codamol (n=1: SPVR), Codeine (n=1: SPVR), Lymecycline (n=1: SPVR), Dianette (n=1: IPVR), cod liver oil and sea kelp (n=1: IPVR), Bisoprolol (n=1: IPVR).
§Reasons for requirement of bypass in patients randomised to IPVR: During chest opening, a laceration was made in the heart. This required urgent cardiopulmonary bypass to stabilise the patient. The valve position was not perfect after it had been deployed and it is not possible to retrieve the valve without going on bypass. The reason the valve position was not perfect was because the patient’s main pulmonary artery was very short and to get the valve in without obstructing his right branch PA meant it had to be deployed more proximally. After deployment of the valve, it was identified that the valve had deployed too proximally. It was functioning well but there was concerns that it would not be stable. Due to the design of the prosthesis, it was not possible to manipulate it into a better position and therefore the decision was made that the valve should be placed in a perfect position. Cardiopulmonary bypass was therefore used to place the valve in such a position, and it was fixed there with excellent short-term and medium-term result. There was an episode of VF while opening the chest. When the valve was implanted, it was felt that it had not opened completely due to areas of calcification in the RVOT/PA. The decision was therefore made to go on bypass and ensure the valve was properly deployed. The valve was implanted but because of the large size of the outflow tract, it became twisted and required removal. A further attempt was made to place the valve but on this occasion, the valve embolised. Cardiopulmonary bypass was instituted to retrieve the valve, then implant it in the correct position. Calcification of RVOT meant off-bypass injection of pulmonary valve was not feasible, therefore valve was replaced on CPB.
¶Norepinephrine: SPVR 1/8 (12.5%), IPVR 2/11 (18.2%); Dopamine: SPVR 0/8 (0.0%), IPVR 4/11 (36.4%); Milrinone: SPVR 1/8 (12.5%), IPVR 2/11 (18.2%); Dobutamine: SPVR 2/8 (25.0%), IPVR 0/11 (0.0%); Enoximone: SPVR1/8 (12.5%), IPVR 0/11 (0.0%); GTN: SPVR 1/8 (12.5%), IPVR 0/11 (0.0%).
ACE, angiotensin-converting-enzyme; CPB, cardiopulmonary bypass; DORV, double outlet right ventricle; GTN, glyceryl trinitrate; IPVR, injectable pulmonary valve replacement; LV, left ventricular; NYHA, New York Heart Association; PA/IVS, pulmonary atresia with intact ventricular septum; PA/VSD, pulmonary atresia with ventricular septal defect; PPIs, proton pump inhibitors; RV, right ventricular; RVOT, right ventricular outlet tract; SPVR, standard pulmonary valve replacement; VF, ventricular fibrillation.