Left Atrial Appendage Occlusion Device, nicvd

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Drug Presentation

Presenter:DR. MD. ARIFUR RAHMAN

MD (Cardiology), Final Part StudentNICVD, DHAKA.

Moderator:

DR. MOHAMMAD ULLAH FIROZAssistant professor, Dept.of CardiologyNICVD, DHAKA.



Left AtrialAppendage

Occlusion Device



Background

Atrial fibrillation (AF) is the most common sustainedcardiac rhythm disturbance, increasing in prevalence withage.

Stroke is the most feared consequence of AF and mostthrombi associated with AF arise within the left atrialappendage.

AF confers an increased relative risk of overall mortality(average 1.7 times controls) and is predominantly causedby stroke.

Stroke prevention is the major focus of management ofpatients with AF.



Background(cont.)

Anticoagulation is the treatment of choice to prevent

stroke in AF.

Anticoagulation has many side effects such as intracranialor gastrointestinal hemorrhage.

Closing the left atrial appendage (LAA) might be analternative in patients who cannot take anticoagulationtreatment due to contraindications, intolerance or

conditions in which the hazard of hemorrhage is greaterthan the potential clinical benefits.



Left Atrial Appendage Occlusion Device Percutaneous occlusion of the LAA is a new approach

used to prevent strokes in high-risk patients with AF.

This device is a permanent implant that blocks theconnection between the left atrium and the LAA, thus

prevents embolism.

Currently, two devices have been developed:

1.The PLAATO system ( Appriva Medical Inc)

2.The WATCHMAN filter system (Atritech, Inc)



The PLAATO device

The PLAATO (Percutaneous Left Atrial AppendageTranscatheter Occlusion) device was the first successfulimplanted occluder in a human.

It was first introduced in August 2001.

The PLAATO framework consists of Nitinol in a basket-

type configuration with a tissueanchoring system on thestruts designed to maintain the correct position of thedevice.



A nonthrombogenic PTFE membrane covers thebasket structure and is designed to seal the orificeof the LAA and allow tissue adhesion.

The device is available in seven sizes ranging from15 to 32 mm in diameter.

The PLAATO device is introduced via a 14-Fr gaugetransseptal sheath system.

The PLAATO device



The PLAATO device

A.PLAATO deviceB. Angiographic view of the PLAATO device after its release

into the left atrial appendage from the delivery catheterC. The device in situ as seen on a plain radiograph



Angiogram of the LAA: (a) after venous and transseptal puncture a specially

designed transseptal sheath is advanced into the LAA,dye injection provides information on the diameter ofthe ostium and the morphology of the LAA

b) proximal and (c) distal dye injection after device’s expansion reveal the degree of occlusion.

The PLAATO device



Transesophageal echocardiography shows the LAA

before(left) and after (right) the PLAATO procedure

The PLAATO device



The WATCHMAN filter system

The Watchman implant is the newest of the LAA

occluding systems and was very recently introduced

into clinical studies (2005).

It is a self-expanding nitinol frame structure coveredwith a permeable (160-micron pores) polyester fabricthat faces the left atrial side of the device.




It has a row of fixation barbs to ensure the greaterstability of the device and is available in diametersranging from 21 to 33 mm.

The Watchman filter system consists of an integral

12-Fr delivery system preloaded with the device and a14-Fr transseptal access sheath. The filter is releaseddistal to the left atrial ostium.






Introduction Sheath With Double and

Single Curve for Different Anatomical Situations



The WATCHMAN® device (Atritech,Inc., North Plymouth, MN)

Syed TM and Halperin JL (2007) Left atrial appendage closure for stroke

prevention in atrial fibrillation: state of the art and current challenges Nat Clin Pract Cardiovasc Med 4: 428–435 doi:10.1038/ncpcardio0933




Successful placement of the device is defined ifthe LAA is completely sealed with absence of flowor minimal flow (jet <3 mm) as measured by TEEat 45 days.





Clinical TrialsPROTECT AF Trial: The WATCHMAN filter system

The effects of the Watchman device on the incidenceof stroke, TIA, systemic embolism, and cardiovasculardeath will be compared to conventional therapy withdose-adjusted warfarin in a multicenter prospective

randomized study in approximately 500 patients with AF.

If TEE performed at 45 days demonstratessatisfactory LAA occlusion, patients who received aWatchman device will discontinue therapy withwarfarin and will receive clopidogrel 75 mg for 6months followed by aspirin 325 mg for the duration ofthe trial (5 years). The study started in December2005.



The PLAATO device:

Within two prospective, multi-center trials, LAAocclusion was attempted in 111 patients (age 71-91years) with PLAATO device since August 2001. Allpatients had a contraindication for anticoagulationtherapy and at least one additional risk factor forstroke.

Among 111 patients, the complication rate was 6% to

7%; the annual rate for stroke or transient ischemicattacks, 5.5%; and the annual mortality, 6.6%.

Clinical Trials



Indication

Age> 18 years with high risk of stroke.

Paroxysmal, persistent or permanent AF.

Contraindications to long term anticoagulationtherapy.

Intolerance to anticoagulation therapy.

Bleeding complications.

S



Summery

The most significant risk associated with atrial

fibrillation (AF) is arterial thromboembolism andstroke.

Conventional anticoagulant therapy is highlyeffective but is not consistently applied to allthose at risk because of the inconvenience ofregular INR monitoring and fears relating to

bleeding complications.



A raft of new drugs and mechanically basedtherapies is now being actively investigated, and

results are promising so far.

It is very likely that the clinical approach to thethromboembolism risk management strategy inpatients with AF will change substantially in thevery near future with a bit of help from cardiacinterventions.

Summery(cont.)



THANK YOU ALL

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Left Atrial Appendage Occlusion Device, nicvd