When not to exclude the LAA Manuel Castellá Cardiovascular Surgery Hospital Clínic, Universidad de Barcelona mcaste@clinic.ub.es @mcastellamd
Normal hearts
Patient in sinus rhythm Patient in AF (with 32 mitral Physio ring)
PROTECT-AF trial Watchman non-inferior to warfarine for primary composite of stroke, cardiovascular death and systemic embolism Safety events 7,4% 50% higher rate of ischemic strokes and embolisms in watchman (17/463 vs 6/244) with 15% of patients with Watchman on anticoagulation
PREVAIL Safety events drops to 2,2% Device did not meet criteria of non-inferiority (6,4%-6,3%). Ischemic strokes: Device 6/269 patients Warfarine 1/138 patients Later Follow-up for 3rd FDA hearing and TCT 2014 (100% patients reached 18 months): Device 13/269 ischemic events Warfarine 1/138 ischemic events JACC 2015;65:2614-2623
Caution
Amplatzer
www.escardio.org/guidelines European Heart Journal - doi:10.1093/eurheartj/ehw 210 Stroke prevention in atrial fibrillation 17 Mechanical heart valves or moderate or severe mitral stenosis Yes No Estimate stroke risk based on number of CHA 2 DS 2 -VASc risk factors 0 a 1 2 No antiplatelet or anticoagulant treatment (IIIB) OAC should be considered (IIaB) Oral anticoagulation indicated Assess for contra-indications Correct reversible bleeding risk factors LAA occluding devices may be considered in patients with clear contraindications for OAC (IIbC) a Includes women without other stroke risk factors b IIaB for women with only one additional stroke risk factor c IB for patients with mechanical heart valves or mitral stenosis NOAC (IA) b VKA (IA) c
www.escardio.org/guidelines European Heart Journal - doi:10.1093/eurheartj/ehw 210 Modifiable and non-modifiable risk factors for bleeding in anticoagulated patients with AF Modifiable bleeding risk factors: Hypertension (especially when systolic blood pressure is >160 mmhg) Labile INR or time in therapeutic range <60% in patients on vitamin K antagonists Medication predisposing to bleeding, such as antiplatelet drugs and non-steroidal antiinflammatory drugs Excess alcohol ( 8 drinks/week) Potentially modifiable bleeding risk factors: Anaemia Impaired renal function Impaired liver function Reduced platelet count or function Non-modifiable bleeding risk factors: Age (>65 years) ( 75 years) History of major bleeding Previous stroke Dialysis-dependent kidney disease or renal transplant Cirrhotic liver disease Malignancy Genetic factors Biomarker-based bleeding risk factors: High-sensitivity troponin Growth differentiation factor-15 Serum creatinine/estimated CrCl
6 experienced surgeons 36% patients, double sutures did not isolate the LAA
1889 consecutive patients No patient presented with bleeding or other complication due to LAA closure 51 randomized patients LAA closure or not closure. 1-year follow up: Death/MI/stroke/emboli/major bleeding LAA closure 4 patients (15.4%) Non-LAA closure 5 patients (20.0%) RR 0.71 95% CI 0.19-2.66
2013. Prospective multicentered randomized trial 4700 patients with AF (CHADS-VASC 2) undergoing cardiac surgery, randomizing LAA closure or not closure. Anticoagulation is maintained. Primary outcome: stroke or embolism over 4 years Other outcomes: mortality, operative safety outcomes, MI
J Thorac Cardiovasc Surg 2003;126:358-64
291 patients ablation surgery + Atriclip 36 months mean follow-up AAS basic treatment postop
2/275 strokes (0,7%, both cardioembolic): Case 1: 25 months after surgery. SR in last ECG, in AAS Case 2: AF in AAS (1/25 pts, 4%) 4 TIA (1.4%)
Conclusions LAA is useful in sinus rhythm There are other zones of possible thrombus (and undetected) LAA closure inferior to warfarin to prevent ischemic strokes and embolism NOACS safer than warfarin and as effective LAA closure could be indicated to patients with clear contraindication for anticoagulation and CHADS 2 -VAS C 2
Conclusions Percutaneous devices 2-4% complications Surgical closure of LAA does not increase morbidity in concomitant procedures Excision or clipping provide 100% closure. Optimal situation to prevent ischemic stroke in the long term: Anticoagulation (Maze + LAA exclusion) ± anticoagulation