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Table 1 Included patients, inclusion / exclusion criteria and demographic data

From: Systematic review on left atrial appendage closure with the LAmbre device in patients with non-valvular atrial fibrillation

 Study typeMain goal of the studyInclusion criteriaMajor exclusion criteriaNo. of patients
subjected to
implantation
of LAmbre®;
(No. of centers)
Age
(years);
(mean + SD)
Males
(n= /
%)
Chen et al. (2019) [21]Open-label, non-randomized, prospective, single-center studySafety, feasibility, and efficacy of LAAC with the LAmbre device in NVAF patientsNVAF, age > 18 years, CHA2DS2-VASc Score > 2, contraindication or intolerance to long-term OAC, refusal of OAC treatment, isolated noncontractile LAA after multiple
AF ablation procedures
clinical conditions not allowing TEE and sedation;
poor peripheral vessel access not allowing device delivery;
LAA thrombus (TEE);
LVEF< 30%;
patients with atrial septal occluder;
stroke or TIA in the past 30 d;
acute myocardial infarction or unstable angina;
decompensated heart failure (New York Heart Association functional class III–IV), or heart transplantation;
rheumatic, significant degenerative, or congenital valvular heart diseases, artificial heart valve replacement operation;
significant and unexplained pericardial effusion (≥4 cm2)
n = 30
(1 center; Germany)
77.6 ± 8.9n = 15 /
50%
Feng et al. (2019) [22]Open-label, non-randomized, prospective, single-center studySafety, feasibility, and efficacy of LAAC with the LAmbre device in NVAF patients with or without prior ablationNVAF, CHADS2 Score > 1, contraindication for or failure of OACLAA orifice diameter < 12 mm;
LAA thrombus (TEE);
LVEF< 30%;
stroke or TIA in the past 30 d:
presence of thrombus in the heart;
prosthetic valve;
myocardial infarction or unstable angina;
acute infective endocarditis;
pregnancy;
symptomatic carotid artery disease;
malignancies with an estimated life expectancy of ≤2 years; allergy to nitinol
n = 17
(1 center; China)
71.4 ± 7.8n = 7 /
41.2%
Reinsch et al. (2018) [19]Retrospective analysis of single-center case seriesSafety, feasibility, and efficacy of LAAC with the LAmbre deviceNVAF, CHA2DS2-VASc Score > 2, HAS-BLED > 3, past bleedingN/An = 11
(1 center; Germany)
72.6 ± 7.9n = 7 /
63.6%
Park et al. (2018) [18]Open-label, non-randomized, prospective, multicenter studySafety, feasibility, and efficacy of LAAC with the LAmbre deviceNVAF> 3 months, > 18 years age, CHA2DS2-VASc Score > 2, and contraindications for OACLAA orifice diameter < 12 mm or > 30 mm, LAA diameter > 65 mm, LAA thrombus (TEE);
LVEF< 30%, NYHA III or IV, prior heart transplantation;
heart rate > 110 beats per minute;
stroke or TIA in the past 30 d;
past LAAC or surgical LAA removal, past ASD closure;
rheumatic, degenerative or congenital valvular heart disease;
recent or acute myocardial infarction or unstable angina;
mechanical valve prosthesis;
scheduled electrophysiological ablation procedure, scheduled pharmacological or electrical cardioversion; pre-procedural pericardial effusion;
signs or symptoms of infection;
pregnancy or breastfeeding;
symptomatic carotid artery disease;
malignancies with an estimated life expectancy of ≤2 years;
allergy to nitinol, thrombocytopenia (platelet ≤100.000 per microliter);
complex atherosclerotic plaques (≥4 mm) in the ascending aorta
n = 60
(2 centers; Germany)
74.4 ± 9.0n = 40 /
66.7%
Kleinecke et al. (2018) [17]Open-label, non-randomized, multicenter observational studySafety, feasibility, and efficacy of LAAC with the LAmbre device and the FuStar steerable sheathCommon indications for LAAC, patients` explicit choiceLAA thrombus (TEE); planed cardiac surgery; history of ASD closure;
endocarditis, active infections
n = 20
(2 centers; Germany)
76.6 ± 8.4n = 12 /
60%
Cruz-Gonzalez et al. (2018) [20]Open-label, non-randomized, prospective, multicenter observational registrySafety and feasibility of LAAC with the LAmbre deviceCommon indications for LAACN/An = 7
(3 centers; Spain)
78.6 + 6.9n = 3 /
42.9%
Chen et al. (2018) [9]Open-label, non-randomized, prospective, single-center observational studySafety, feasibility and efficacy of LAAC with the LAmbre deviceCommon indications for LAACN/An = 30
(1 center; Germany)
77.6 ± 8.9n = 15 /
50.0%
Zhou et al. (2017) [16]Open-label, non-randomized, prospective, single-center observational studyValue of 3D-TEE guidance of LAAC (LAmbre and Lefort)NVAF, CHA2DS2-VASc Score > 2, contraindications for OACLAA thrombus (TEE); LVEF< 40%, NYHA IV; myocardial infarction within the last 3 months;
vascular abnormalities interfering with LAAC
n = 21
(1 center; China)
66.6 ± 8.5n = 15 /
71.4%
Huang et al. (2017) [15]Open-label, non-randomized, prospective, multicenter study (NCT02029014)Safety, feasibility, and efficacy of LAAC with the LAmbre deviceNVAF > 18 years age with CHADS2 Score > 1 and not suitable for long term OAC/VKALAA orifice diameter < 12 mm;
LAA thrombus (TEE);
LVEF< 30%, NYHA IV;
stroke or TIA in the past 30 d;
past ASD closure;
infective endocarditis;
hemorrhagic disease;
pregnancy;
endocarditis;
prosthetic valve
n = 153
(12 centers; China)
69.3 +  9.4n = 87 /
56.2%
Jie et al. (2016) [14]Open-label, non-randomized, single-center observational studyInvestigation on changes of ECG and echocardiographic parameters after LAACNVAF, history of previous bleeding, high risk of bleeding, inability to adhere with OACLAA orifice diameter < 12 mm or > 30 mm;
LAA thrombus (TEE);
LVEF< 30%;
mitral valve stenosis
n = 54
(1 center; Germany)
71.1 ± 9.1n = 34 /
63.0%
Total /
Overall mean
    40373.6 + 4.0n = 235 /
58.3%
  1. §: 1 enrolled patient did not undergo LAAC due to the anatomy of the interatrial septum not suitable for transseptal puncture
  2. Abbreviations
  3. ABL Acute brain lesions
  4. ASD Atrial septum defect
  5. IAS Interatrial septum
  6. LAA Left atrial appendage
  7. LAAC Closure of the left atrial appendage
  8. MRI Magnetic resonance imaging
  9. N/A Not available
  10. NOAC New oral anticoagulants
  11. NVAF Non-valvular atrial fibrillation
  12. OAC Oral anticoagulation
  13. VKA Vitamin K antagonists