Table 1:
Best evidence papers
| S. no. | Author, date, journal and country Study type (level of evidence) |
Patient group Prosthesis ICH location |
Management | Outcomes | Key results | Comments |
|---|---|---|---|---|---|---|
| 1 | Ananthasubramaniam et al. (2001), Chest, USA [2] Retrospective (level III) |
3 of 28 patients with ICH Mitral: 1 Aortic: 1 Double: 1 Intracranial: 2 Subdural: 1 |
All reversed with FFP and one with vitamin K and OAC started on 15 ± 4 days with no thromboembolic phenomenon | Follow-up for 6 months with two deaths (acute event). One death at 4 months at home with unknown reason (on ASA) | All patients’ OAC stopped and safely started without any valve-related complication | Safe to withhold OAC and can be started in ∼2–3 weeks of time |
| 2 | Babikian et al. (1988), Stroke, USA [3] Retrospective (level V) |
6 patients with ICH Prosthetic site not reported Parietal: 2 Frontal: 1 Subdural: 3 |
Treatment strategy not reported OAC started on mean of 19 days with no thromboembolic phenomenon | Follow-up for 6 months with one death due to bacterial endocarditis | All patients’ OAC stopped and safely started without any valve-related complication | Safe to withhold OAC and can be started in ∼2–3 weeks of time |
| 3 | Butler et al. (1998), Br J Haematol, Scotland [4] Retrospective (level III) |
16 patients with ICH Mitral: 7 Aortic: 5 Double: 1 Intracerebral haemorrhage: 4 SAH: 1 SDH: 7 Intraspinal haemorrhage: 1 |
Treatment strategy not reported OAC started on mean of 7 days and 10 patients received iv heparin from day 3, 4 thromboembolic phenomenon | Follow-up for 23.5 months with two deaths due to acute event and two deaths in follow-up, one with neurological sign and other suffered myocardial infarction | All patients’ OAC stopped and safely started with 4 patients having valve-related complication | Safe to withhold OAC for short period and can be started in ∼1 week with target. INR on lower side has definite advantage of no recurrent bleeding may be on cost of thromboembolism |
| 4 | Leker et al. (1998), Neurology, Israel [5] Prospective (level V) |
4 patients with ICH Prosthetic site not reported Cerebellar: 1 Hemispheric: 3 |
All reversed with FFP and vitamin K. All patients given heparin within 24 h except one whom it was started after 36 h, with no thromboembolic phenomenon |
Followed up till discharge with clinical and repeat CT scan. No death or valve-related complication | All patients’ OAC stopped and were safely given heparin without any complication | Safe to withhold OAC and early institution on heparin is safe and effective |
| 5 | Phan et al. (2000), Arch Neurol, USA [6] Retrospective (level III) |
52 patients with ICH Mitral: 14 Aortic: 31 Double: 7 ICH location not reported |
All reversed with FFP and vitamin K. All patients given heparin or warfarin from 1 to 4 weeks with one thromboembolic complication |
Followed up for 30 days with 22 deaths not related to valve-related complication | All patients’ OAC stopped and safely OAC or heparin started without any valve-related complication | Safe to withhold anticoagulant for a brief period, i.e. 7–28 days with a median of 10 days |
| 6 | Wijdicks et al. (1998), Neurosurgery, USA [7] Retrospective (level III) |
39 patients with ICH Mitral: 16 Aortic: 20 Double: 3 SDH: 20 SAH: 4 Ganglionic: 2 Lobar: 10 Cerebellar: 3 |
Most of them reversed with FFP, and some of them given vitamin K. All patient started on OAC on median of 8 days (2 days to 3 months) with 5 patients received heparin |
Followed up for >3 months with 14 deaths of which 13 were due to acute event and 1 after 3 years following haemorrhage | All patients’ OAC stopped and safely OAC started without any valve-related complication and 5 patients were also given heparin | Safe to withhold anticoagulant for a brief period, i.e. 2–90 days with a median of 8 days |
| 7 | Claassen et al. (2008), Arch Neurol, USA [8] Retrospective (level III) |
12 of 48 patients with ICH Aortic: 8 Double: 2 ICH location not reported |
Reversal treatment strategy not reported, 12 patients started on OAC on median of 10 days (7–28 days) | Followed up for 43 months with two deaths in patients where OAC not restarted, one CCF and other comorbidity and one myocardial infarction | All patients’ OAC stopped and safely OAC started in 10 without any valve-related complication, excluding 2 deaths which were not related to valve or ICH | OAC can be safely withheld in patients with ICH for a short duration like 7–28 days but reinstitution of OAC definite advantage of preventing unnecessarily thromboembolic complication |
| 8 | De Vleeschouwer et al. (2005), Acta Chir Belg, Belgium [9] Prospective (level III) |
30 of 108 patients with ICH Mitral: 9 Aortic: 14 Tricuspid: 2 Multiple: 5 ICH location not reported |
Reversal treatment strategy used vitamin K, FFP and PCC but not uniformly used. Nineteen patients restarted on OAC with median interval of 11 days, and all of them received LMWH day after stabilization or surgery |
Followed up for 12 months with 23% mortality and thromboembolic complication reported in 1 patient in the form of myocardial infarction (not due to valve thrombosis) | All patients’ OAC stopped and safely OAC started in 19 with 1 patient reported to have complication | OAC can be safely withheld in patients with ICH for ≥3 weeks safely with urgent reversal of coagulopathy and reinstitution of OAC on priority basis |
| 9 | Bertram et al. (2000), J Neurol, Germany [10] Retrospective (level III) |
10 of 15 patients with ICH Mitral: 5 Aortic: 4 Double: 1 Cerebellar: 2 Hemispheric: 2 SAH: 2 Thalamic: 2 Temporal: 2 |
All reversed with PCC, FFP and vitamin K. All patients were started on heparin on full dose except 1 where low dose given | Followed up till discharge with no mortality and four complications (two rebleeding and two cerebral infarctions) in infarct patient 1 was on low-dose heparin and other heparin was withheld for surgical point of view | All patients’ OAC stopped and were started on heparin in 1–3 days with four complications | Safety of withdrawal of anticoagulant for >1 week in acute management of ICH cannot be maintained as guideline but reinstituting full-dose heparin in high-risk patient for thromboembolism is must ones INR has normalized and no surgical contraindication |
| 10 | Kawamata et al. (1995), Surg Neurol, Japan [11] Retrospective (level III) |
20 of 27 patients with ICH Prosthetic site not reported ICH location not reported |
All reversed with PCC, FFP and vitamin K. All patients were given heparin soon after haemorrhage was under control and OAC started to all from day 3 to 30 days | Follow-up not clearly defined with five total mortality in whole series (including those without prosthetic valve in situ) and one thromboembolic complication | All patients’ OAC stopped and were started on heparin as haemorrhage was controlled and OAC started to all from day 3 to 30 days with one complication | OAC needs to be stopped immediately following ICH with rapid reversal of same, keeping in view early reinstitution of anticoagulant in the form of heparin and OAC keeping in myocardial infarction and the risk benefit ratio of thromboembolism and bleeding |
OAC: oral anticoagulant; ICH: intracranial haemorrhage; CCF: congestive cardiac failure, LMWH: low molecular weight heparin, FFP: fresh frozen plasma; PCC: prothrombin concentration.