Page 11 - Journal of Structural Heart Disease Volume 1, Issue 4

Meeting Abstracts
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LAA length was longer in 21 of 22 patients versus 2D TEE (p<0.001). There were no LAA ruptures. Each patient required only 1 device size. There were 3 peri-watchman leaks (< 5mm) secondary to accesso- ry LAA pedunculation and not device sizing. 2D TEE maximal width would have required bigger device in 9 / 22(40.9%) patients. 3DTEE maximal width would have required bigger device in 7 / 22(31.8% ). 2D TEE length would have excluded 5 patients from LAA occlusion.
Conclusion: CT guided LAA sizing is superior to 2D and 3DTEE assessment.
DELIVERABILITY, CONFORMABILITY, AND HEALING RESPONSE OF WATCHMAN FLX LAAC DEVICE
Elena Ladich1 Dongming Hou2, Brian Tischler2, Alex P ugfelder 2, Barbara Huibregtse2, Renu Virmani1
CVPath1 & BSC2 , USA
Background: WATCHMAN FLX ( WM-FLX) is the next generation WATCHMAN (WM) device.
Objective: The aim of this study is to compare WM-FLX and WM for implant deliverability, LAA conformability, and for biologic healing response at 45 and 90 days in the canine model.
Methods: LAA ostium was measured under TEE to determine device sizing. WM-FLX devices were implanted in 12 canines to evaluate the healing response. Half were terminated at 45d and half at 90d, re- spectively.
Results: 100% of WM-FLX canines (6/6) and 75% of WM canines (6/8) were successfully deployed (one excluded due to pericardial e usion, one for unfavorable LAA). The WM-FLX cohort required fewer partial and full recaptures. WM-FLX had no observed peri- device jets. (Table 1).
Table 1: Deliverability and Conformability Comparison
RATIONALE OF CEREBRAL PROTECTION DEVICES IN LEFT ATRIAL APPENDAGE OCCLUSION
Felix Meincke1, Felix Kreidel1, Tobias Spangenberg1, Christian Frerker1, Oscar Sanchez2, Elena Ladich2, Karl-Heinz Kuck1, Alexander Ghanem1
1 Asklepios Klinik St. Georg, Abteilung für Kardiologie, Hamburg, Germany
2 CV Path Institute Inc., Gaithersburg, USA
Background: Periprocedural stroke has been reported after interven- tional left atrial appendage occlusion (iLAAO). In transcatheter aor- tic valve replacement (TAVR), the use of a cerebral protection device has been shown to reduce cerebral lesions assessed with magnetic resonance imaging. Our aim was to assess the feasibility of cerebral protection devices in iLAAO and to analyze the amount and type of debris captured.
Methods: In ve consecutive patients undergoing iLAAO, the Senti- nel CPS® cerebral protection device was used. For iLAAO, the Watch- man® device was used in two patients and the Amulet® in three. After iLAAO, the lters underwent histopathological examination.
Results: A total of 10 lters (one proximal and one distal lter for each patient) were collected and underwent histopathological analysis (CV Path Institute Inc.). Debris was found in all patients (9/10 lters). Acute thrombus was found in 3 patients (2 Watchman®; 1 Amulet®), organizing thrombus in 4 patients (1 Watchman®; 3 Amulet®). Two Amulet® patients had endocardial or myocardial tissue in their lters. None of the lters included calci cations or other foreign material. The maximal diameter of the collected material was 0.68 (±0.9) mm.
Conclusion: As expected, iLAAO can cause embolization of thrombot- ic material and other debris, either preexisting (e.g. embolization of echocardiographically undetected LAA thrombus) or induced by the procedure. This nding strongly encourages further investigations of the underlying mechanisms for embolization of di erent types of material, as well as the clinical impact of microemboli. Potential dif- ferences in thrombogenic potential between devices should also be addressed in future investigations. The potential for thrombo- embo- lism should be taken into account for device design and implantation techniques.
RATIONALE OF CEREBRAL PROTECTION DEVICES IN LEFT ATRIAL APPENDAGE OCCLUSION
Felix Meincke1, Felix Kreidel1, Tobias Spangenberg1, Christian Frerker1, Oscar Sanchez2, Elena Ladich2, Karl-Heinz Kuck1, Alexander Ghanem1
1 Asklepios Klinik St. Georg, Abteilung für Kardiologie, Hamburg, Germany
2 CV Path Institute Inc., Gaithersburg, USA
Background: Periprocedural stroke has been reported after interven- tional left atrial appendage occlusion (iLAAO). In transcatheter aor- tic valve replacement (TAVR), the use of a cerebral protection device has been shown to reduce cerebral lesions assessed with magnetic resonance imaging. Our aim was to assess the feasibility of cerebral protection devices in iLAAO and to analyze the amount and type of debris captured.
Methods: In ve consecutive patients undergoing iLAAO, the Senti-
WM
WM-FLX
Total devices/dogs used Full recaptures
Partial recaptures
Dogs with Peri-device jet (<2mm)
10/6 6/6 4 2
3 2 2 0
WM-FLX showed a similar biologic healing response when compared to WM at both 45d and 90d. Endocardial tissue growth was complete to near-complete in all devices with the exception of single canine from the WM group at 90d in which there was minimal thrombus associated with slight protrusion of the device into the left atrium. In ammation was minimal in all devices.
Conclusion: WM-FLX showed an improvement in both deliverability and LAA conformability, and had a similar healing response com- pared to WM.
Journal of Structural Heart Disease, December 2015
Volume 1, Issue 4: 155-159