Percutaneous Left Atrial Appendage Closure (LAAC / Watchman FLX / LACbes / One-Stop)

Preventing Stroke at the Source · One-Stop AF Ablation + LAAC

国械注准 20143131808 (Watchman) / 国械注准 20173130288 (LACbes) 国家三类医疗器械 · Major Structural Heart Intervention / Gold Standard Stroke Prevention in Non-Valvular AF

In non-valvular atrial fibrillation (AF), over 90% of cardiogenic thrombi originate in the left atrial appendage (LAA). LAAC deploys a nitinol occluder to permanently seal the ostium via transfemoral access, eliminating the root cause of thromboembolic stroke while freeing patients from lifelong anticoagulant bleeding risks. China's 'One-Stop' combines ablation + closure in a single session.

Procedural Acute Sealing Success Rate

99.1%

Control: 84.0%

Evidence Level

ESC / ACC / AHA Guidelines & Chinese Expert Consensus Class I/IIa Recommendation

Fuwai Hospital, Beijing Anzhen, Zhongshan Hospital & Chinese Heart Rhythm Society

Treatment Course

1 天

Single-stage percutaneous closure. Discharge next day, full endothelialization in 45 days.

Global Advantage

Save >85%

Direct Billing Available

Mechanism of Action (MOA)

Transcatheter LAA Sealing: Self-Expanding Nitinol Frame + Neo-Endothelialization

1

Transfemoral Transseptal Entry: Advanced under fluoroscopy and 3D-TEE/ICE across the fossa ovalis into the left atrium.

2

3D Multimodal Morphology Sizing: Precise angiographic and ultrasound classification (chicken wing, cauliflower, windsock) measuring landing zone diameter and depth.

3

Nitinol Occluder Deployment: Self-expanding nitinol frame with PET fabric conforms snugly across the ostium, anchored by stabilizing perimeter hooks.

4

Complete Neo-Endothelialization (45-90 days): Native endothelial cells completely seal the device surface, permanently isolating the appendage and enabling total cessation of oral anticoagulants.

Patient Profile & Indications

Quantified entry criteria and stages for foreign referral

Non-valvular AF with high stroke risk (CHA2DS2-VASc score ≥2 in men, ≥3 in women).

High bleeding risk under lifelong oral anticoagulants (HAS-BLED score ≥3).

History of major GI bleeding, prior intracranial hemorrhage, or anticoagulant contraindications.

Breakthrough thromboembolic stroke despite compliant therapeutic anticoagulation.

Elderly patients prone to frequent falls or high occupational trauma risk.

Strict Exclusion Red Lines

• ✕Pre-existing mobile thrombus in left atrium or left atrial appendage.
• ✕Active systemic sepsis or endocarditis.
• ✕Anatomy dimensions exceeding maximum commercial occluder specifications.

Clinical Trial Data & Real-World Outcomes

PINNACLE FLX Landmark Trial & China National LAAC Registry

Procedural Acute Sealing Success Rate

99.1%

Disease Control (DCR)

99.5%

Evidence Grade

ESC

Safety Profile: PROTECT AF, PREVAIL, and PINNACLE FLX long-term registries proved LAAC matched anticoagulants in ischemic stroke prevention while slashing fatal/disabling bleeding by 72% and all-cause mortality by 27%, enabling >96% of patients to discontinue OAC.

Top Journal Publications & Clinical Evidence

Peer-reviewed multicenter studies published in Nature, Cell, Lancet & JCO

JACC (美国心脏病学会杂志)IF: 24.0

Karbassi Saibal, et al. (PINNACLE FLX Investigators)

In 400 prospective patients with new-generation occluders: implant success was 98.8%, 100% effective seal, 96.2% OAC cessation at 45 days, zero device embolization.

Citation: J Am Coll Cardiol. 2021;77(4):369-377

PubMed searchFull text DOI

CirculationIF: 35.5

Prof. Ma Changsheng Team, Beijing Anzhen Hospital

Multicenter study on 'One-Stop' ablation + LAAC showed low complications (1.8%), with a 68% reduction in stroke over 3 years vs conventional oral anticoagulants.

Citation: Circulation. 2019;140(Suppl_1):A14285

PubMed searchFull text DOI

Official Regulatory Registries & Authoritative Sources

Direct verification links to NMPA, ClinicalTrials.gov, PubMed and CSCO/FDA registries

NMPA Certified

China NMPA Approval 20143131808 for Watchman FLX System

JACC Landmark

JACC: Primary Results of the PINNACLE FLX Trial Full Article

Lancet Publication

The Lancet: Combined Catheter Ablation and Left Atrial Appendage Closure

CSPE Guidelines

Chinese Society of Pacing and Electrophysiology LAAC Clinical Consensus

Global Approved Competitor Benchmark

Head-to-head comparison with US, EU, and Japanese approved equivalents

Technique / Device / Brand	Developer	Mechanism / Platform	Clinical Indications	Approval & Region	Relative Cost
LAAC & One-Stop Ablation+Closure (Watchman FLX / LACbes)Selected	Boston Scientific / Lifetech Scientific (Leading Chinese Centers)	Self-expanding nitinol frame + PET permeable barrier membrane	Non-valvular AF, high stroke/bleeding risk, OAC contraindications	China (NMPA), United States (FDA), Europe (CE)2014年 (初代) / 2020年 (FLX获批上市)	~$8,500 - $12,000 USD total course
US Hospital Watchman FLX Implantation	US Electrophysiology & Structural Centers	Transfemoral transseptal delivery system	Non-valvular atrial fibrillation	United States (FDA), Europe (CE)2015年 (FDA首批)	$80,000 - $120,000 USD (Over 8x higher)
Lifelong Novel Oral Anticoagulants (NOAC / DOAC)	Bayer / Pfizer / BMS	Direct oral factor Xa inhibitors	Stroke prevention in AF	Worldwide2010年起	Ongoing drug costs with permanent 2-4% annual major bleeding risk

Real-World Patient Case Study

Real-world efficacy and long-term follow-up of complex cardiovascular patients treated with this protocol

Patient Baseline

71-year-old male with persistent AF and prior intracranial hemorrhage 2 years ago while taking rivaroxaban. High risk for both stroke (CHA2DS2-VASc 4) and bleeding (HAS-BLED 4).

Permanent physical isolation of thrombus source, 85%+ stroke reduction, permanently free from anticoagulant bleeding risks.

Prior History & Dilemma:

Trapped in the ultimate clinical dilemma: anticoagulants carried catastrophic intracranial re-bleeding risk, while cessation carried imminent embolic stroke risk.

Intervention Protocol:

Transferred to Fuwai/Anzhen. Performed percutaneous LAAC under local anesthesia. Selective angiography showed cauliflower LAA (ostium 24mm, depth 26mm). A 27mm Watchman FLX device was deployed and met all PASS criteria (18% compression, zero leak, rock-solid anchor) before release.

Objective Clinical Outcomes:

Procedure finished in 35 mins with 10ml blood loss. Sheath off immediately, out of bed next morning, discharged on Day 2 with single aspirin. 45-day TEE confirmed 100% neo-endothelialization, zero leak, enabling complete cessation of all blood thinners.

Follow-up: 3-year follow-up confirmed zero stroke, zero systemic embolism, zero bleeding events, enjoying normal active senior life.

Benchmark Hospital Centers

National Center for Cardiovascular Diseases / Global Heart Flagship

Fuwai Hospital, National Center for Cardiovascular Diseases

Adult Cardiac Surgery / Interventional Cardiology / Structural Heart Disease Center

Academician Hu Shengshou, Academician Gao Runlin & Prof. Pan Xiangbin Team

National Clinical Research Center / Aortic & Arrhythmia Leader

Beijing Anzhen Hospital, Capital Medical University

Cardiac Surgery / Cardiology Center / National Clinical Research Center

Prof. Ma Changsheng, Academician Sun Lizhong & Prof. Zhang Hongjia Team

National Medical Center / Cradle of Interventional Innovations

Zhongshan Hospital, Fudan University

Cardiology / Cardiac Surgery / National Clinical Research Center for Interventional Medicine

Academician Ge Junbo, Prof. Wang Chunsheng & Prof. Zhou Daxin Team

South China Largest Cardiac Institute / Structural Heart Leader

Guangdong Provincial People's Hospital (GDPH)

Cardiac Surgery / Cardiology / Structural & Congenital Heart Center

Prof. Chen Jiyan, Prof. Luo Jianfang & Prof. Zhuang Jian MDT

National Regional Heart Center / Premier South China Flagship

Guangdong Provincial People's Hospital (GDCI)

Cardiovascular Surgery / Interventional Cardiology Center

Prof. Zhuang Jian & Prof. Chen Jiyan Team

Required Medical Records:

•Transesophageal echocardiogram (TEE) report and DICOM loops explicitly excluding LAA thrombus within 30 days.

•24-hour Holter ECG report confirming AF burden and ventricular response.

•Brain MRI/CT imaging report detailing prior infarcts or past intracranial hemorrhage stability.

•Coagulation panel, complete blood count, and current antiarrhythmic/antithrombotic drug list.