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TCT-619 Periprocedural Intracardiac Echocardiography from the Left Atrium for Left Atrial Appendage Occlusion with the Amplatzer Cardiac PlugTM
B252
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
and reflected stroke severity. One-way and probabilistic sensitivity analyses were performed. RESULTS Over a lifetime, LAAC provided an additional 0.35 life years (LY) and 0.52 QALYs relative to warfarin and an additional 0.17 LYs and 0.23 QALYs relative to NOACs. LAAC was dominant (more effective and less costly) relative to warfarin and NOACs. NOACs were cost effective but not cost saving relative to warfarin. In sensitivity analyses, LAAC was cost effective in 97% and 90% of simulations relative to warfarin and NOACs, respectively. Incremental Cost/QALY
Incremental
versus
Cost/QALY
Total LYs
Total QALYs
Total Costs
Warfarin
versus NOAC
LAAC
8.34
5.80
$30,427
$10,945
Dominant
Warfarin
8.25
5.59
$28,125
–
–
NOACs
8.30
5.74
$40,712
$82,774
–
10 Years
20 Years LAAC
12.12
7.88
$40,567
Dominant
Dominant
Warfarin
11.77
7.36
$52,264
–
–
NOACs
11.95
7.65
$64,212
$40,913
–
CONCLUSION Using pooled PROTECT AF and PREVAIL clinical data, LAAC proved to be a cost-effective and cost-saving treatment relative to warfarin and NOACs. These findings are consistent with previous analyses and should be considered when formulating policy and practice guidelines for stroke prevention in AF. CATEGORIES ENDOVASCULAR: Stroke and Stroke Prevention
TCT-618 Safety and Efficacy of Left Atrial Appendage Closure With the Watchman Device in Patients Older Than 85 Years Old: Data From the Prospective EWOLUTION Registry Ignacio Cruz Gonzalez,1 Hüseyin Ince,2 Boris Schmidt,3 Pascal Defaye,4 Leif-Hendrik Boldt,5 Robin Molitoris,6 Jean-Benoit Thambo,7 Christof Wald,8 Kenneth Stein, MD,9 Lucas Boersma10 1 University Hospital of Salamanca, Salamanca, Spainn; 2Vivantes Klinikum Am Urban, Berlin, Germany; 3Cardioangiologisches Centrum Bethanien (CCB), Frankfurt Am Main, Germany; 4University Hospital of Grenoble-Alps, Grenoble, France; 5Charite, Berlin, Germany; 6 Krankenhaus Barmherzige Bruder, Regensburg, Germany; 7Hopitaux du Haut Leveque, Pessac, France; 8Dominikus Krankenhaus, Duesseldorf, Germany; 9Boston Scientific, Saint Paul, Minnesota, United States; 10St.Antonius Hospital, Nieuwegein, Netherland BACKGROUND Atrial fibrillation aged patients present a greater risk of cardioembolic events and major bleeding, LAAC could an attractive alternative for these patients however its safety and efficacy have not been reported previously in the subgroup of patients 85 years old. The objective of the study was to assess the safety and efficacy of left atrial appendage closure (LAAC) in patients 85 years old. METHODS Data from the EWOLUTION registry were analyzed. The cohort was categorized in 2 groups (<85 vs 85 years) and safety and efficacy events were recorded for both groups. RESULTS A total of 1024 patients included in the EWOLUTION registry who underwent LAAC with WATCHMAN were analyzed and 85 patients 85 years old were identified. This subgroup of patients had higher embolic and hemorrhagic risk than the younger patients. (CHA2DS2-VASc 5.14 1.16 vs 4.42 1.61; p <0.001, HAS-BLED: 2.71 1.09 vs 2.28 1.23; p¼0.002. Patients 85 years vs < 85 years). Procedural success was high and similar in both groups (98.8% vs 98.5%; p¼1.0). There were no differences in peri-procedural device or procedure related serious adverse event rates (2.6% in 85 years vs 3.0% in < 85 years; p ¼ 0.82). After 3 months of follow-up there were no differences in stroke rates between groups (1.3% in 85 years vs 0.4% in < 85 years; p¼0.21), nor in bleeding rates (5.2% in 85 years vs 3.9% in < 85 years; p¼0.56). CONCLUSION LAAC in patients 85 years is safe and effective even if this subgroup of patients is at high risk for embolic and hemorrhagic events. LAAC could be an alternative to oral anticoagulation for these patients. CATEGORIES STRUCTURAL: Left Atrial Appendage Exclusion
TCT-619 Periprocedural Intracardiac Echocardiography from the Left Atrium for Left Atrial Appendage Occlusion with the Amplatzer Cardiac PlugTM Zied FRIKHA,1 Ayoub El hammiri,2 Jeannot Potvin,3 Jean-Marc Raymond,4 Jean-Bernard Masson5 1 Departement d’hémodynamie, Centre hospitalier de l’Université de, Montreal, Quebec, Canada; 2Centre hospitalier de l’Université de Montréal, Montreal, Quebec, Canada; 3CHUM, Montreal, Quebec, Canada; 4Glenfield Hospital, University Hospitals of Leicester, UK; 5 CHUM, Montreal, Quebec, Canada BACKGROUND Imaging is of great relevance during all phases of left atrial appendage occlusion (LAAO). General anesthesia required by transesophageal echocardiography (TEE) can be avoided with intracardiac echocardiography (ICE) guidance. However, ICE-guided LAAO experience is limited. Our aim was to demonstrate the utility and safety of ICE from the left atrium (LA) in providing adequate imaging guidance during Amplatzer Cardiac Plug (ACP)TM and second generation AmuletTM (St.Jude Medical Inc. St.Paul’s MN) implantation. METHODS From October 2012 to June 2016 in a single Montreal center, ICE-guided percutaneous LAAO with ACP or Amulet was performed in 51 patients, the ICE catheter being placed in the LA through a second transseptal puncture. Baseline characteristics, procedural and follow-up data were prospectively recorded. TEE and clinical follow-up was performed at 3 months. Procedural success was defined as peridevice residual leak <3 mm. RESULTS LAAO was performed in 51 nonvalvular atrial fibrillation patients with long-term oral anticoagulant contraindication. Mean age was 74.4 7.6 years (range, 60-92 y). Mean CHADS2, CHA2DS-VASc and HASBLED scores were 3.61.4, 4.91.3 and 3.91.0, respectively. Success rate of device implantation was 98%. Median total procedural time was 90 min (IQR 77:116) and average amount of contrast used 14864 mL. In 80.4% of procedures, the first selected device was implanted. In all cases, ICE provided adequate procedural guidance. There was no procedural stroke, device embolization or ICE-related complication. Major complications occurred in 2 patients: tamponade needing surgical repair and silent myocardial infarction. Three patients had access site hematomas. Median hospital stay was 1 day. At 3 months follow-up, successful LAAO was observed in 50 of the 51 patients. No stroke occurred and three patients died during the followup period, all were non-procedure related deaths. CONCLUSION This pilot experience suggests that ICE from the LA was able to perform the tasks typically provided by TEE during ACP or Amulet device implantation. ICE avoids general anesthesia and is a safe and useful ultrasound option for guidance of LAAO. CATEGORIES STRUCTURAL: Left Atrial Appendage Exclusion TCT-620 A comparison of clinical outcomes between triple antithrombotic therapy versus dual antiplatelet with left atrial appendage occlusion in patients with atrial fibrillation undergoing drug-eluting stent implantation Seung Hun Lee,1 Jae Young Cho,2 Hyung Joon Joo,3 Jae Hyoung Park,4 Soonjun Hong,5 Cheol Woong Yu,6 Do Sun Lim 7 1 Anam Hospital, Korea University Medical Center., Seoul, Korea, Republic of; 2Korea University Cardiovascular center, Seoul, Korea, Republic of; 3Korea University Anam Hospital, Seoul, Korea, Republic of; 4Korea University Anam Hospital, Seoul, Korea, Republic of; 5Korea University College fo Medicine, Seoul, Korea, Republic of; 6Korean University Anam Hospital, Seoul, Korea, Republic of; 7Korea University Anam Hospital, Seoul, Korea, Republic of BACKGROUND There have been debates about optimal antithrombotic therapy for patients with atrial fibrillation (AF) undergoing drug-eluting stent (DES) implantation. We compared clinical outcomes between triple antithrombotic therapy (TATT) versus dual antiplatelet therapy (DAPT) with left atrial appendage occlusion (LAAO) in patients with AF undergoing DES implantation. METHODS We analyzed total 461 patients with AF who undergoing DES implantation from June 2006 to June 2014. Among 461 patients, we identified 151 patients with TATT. We did matched-analysis between 151 TATT and 27 patients with DAPT after LAAO. Primary end point was a net clinical outcomes, defined as a composite of all-cause death, myocardial infarction, transient ischemic attack or stroke and major bleeding.
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
and reflected stroke severity. One-way and probabilistic sensitivity analyses were performed. RESULTS Over a lifetime, LAAC provided an additional 0.35 life years (LY) and 0.52 QALYs relative to warfarin and an additional 0.17 LYs and 0.23 QALYs relative to NOACs. LAAC was dominant (more effective and less costly) relative to warfarin and NOACs. NOACs were cost effective but not cost saving relative to warfarin. In sensitivity analyses, LAAC was cost effective in 97% and 90% of simulations relative to warfarin and NOACs, respectively. Incremental Cost/QALY
Incremental
versus
Cost/QALY
Total LYs
Total QALYs
Total Costs
Warfarin
versus NOAC
LAAC
8.34
5.80
$30,427
$10,945
Dominant
Warfarin
8.25
5.59
$28,125
–
–
NOACs
8.30
5.74
$40,712
$82,774
–
10 Years
20 Years LAAC
12.12
7.88
$40,567
Dominant
Dominant
Warfarin
11.77
7.36
$52,264
–
–
NOACs
11.95
7.65
$64,212
$40,913
–
CONCLUSION Using pooled PROTECT AF and PREVAIL clinical data, LAAC proved to be a cost-effective and cost-saving treatment relative to warfarin and NOACs. These findings are consistent with previous analyses and should be considered when formulating policy and practice guidelines for stroke prevention in AF. CATEGORIES ENDOVASCULAR: Stroke and Stroke Prevention
TCT-618 Safety and Efficacy of Left Atrial Appendage Closure With the Watchman Device in Patients Older Than 85 Years Old: Data From the Prospective EWOLUTION Registry Ignacio Cruz Gonzalez,1 Hüseyin Ince,2 Boris Schmidt,3 Pascal Defaye,4 Leif-Hendrik Boldt,5 Robin Molitoris,6 Jean-Benoit Thambo,7 Christof Wald,8 Kenneth Stein, MD,9 Lucas Boersma10 1 University Hospital of Salamanca, Salamanca, Spainn; 2Vivantes Klinikum Am Urban, Berlin, Germany; 3Cardioangiologisches Centrum Bethanien (CCB), Frankfurt Am Main, Germany; 4University Hospital of Grenoble-Alps, Grenoble, France; 5Charite, Berlin, Germany; 6 Krankenhaus Barmherzige Bruder, Regensburg, Germany; 7Hopitaux du Haut Leveque, Pessac, France; 8Dominikus Krankenhaus, Duesseldorf, Germany; 9Boston Scientific, Saint Paul, Minnesota, United States; 10St.Antonius Hospital, Nieuwegein, Netherland BACKGROUND Atrial fibrillation aged patients present a greater risk of cardioembolic events and major bleeding, LAAC could an attractive alternative for these patients however its safety and efficacy have not been reported previously in the subgroup of patients 85 years old. The objective of the study was to assess the safety and efficacy of left atrial appendage closure (LAAC) in patients 85 years old. METHODS Data from the EWOLUTION registry were analyzed. The cohort was categorized in 2 groups (<85 vs 85 years) and safety and efficacy events were recorded for both groups. RESULTS A total of 1024 patients included in the EWOLUTION registry who underwent LAAC with WATCHMAN were analyzed and 85 patients 85 years old were identified. This subgroup of patients had higher embolic and hemorrhagic risk than the younger patients. (CHA2DS2-VASc 5.14 1.16 vs 4.42 1.61; p <0.001, HAS-BLED: 2.71 1.09 vs 2.28 1.23; p¼0.002. Patients 85 years vs < 85 years). Procedural success was high and similar in both groups (98.8% vs 98.5%; p¼1.0). There were no differences in peri-procedural device or procedure related serious adverse event rates (2.6% in 85 years vs 3.0% in < 85 years; p ¼ 0.82). After 3 months of follow-up there were no differences in stroke rates between groups (1.3% in 85 years vs 0.4% in < 85 years; p¼0.21), nor in bleeding rates (5.2% in 85 years vs 3.9% in < 85 years; p¼0.56). CONCLUSION LAAC in patients 85 years is safe and effective even if this subgroup of patients is at high risk for embolic and hemorrhagic events. LAAC could be an alternative to oral anticoagulation for these patients. CATEGORIES STRUCTURAL: Left Atrial Appendage Exclusion
TCT-619 Periprocedural Intracardiac Echocardiography from the Left Atrium for Left Atrial Appendage Occlusion with the Amplatzer Cardiac PlugTM Zied FRIKHA,1 Ayoub El hammiri,2 Jeannot Potvin,3 Jean-Marc Raymond,4 Jean-Bernard Masson5 1 Departement d’hémodynamie, Centre hospitalier de l’Université de, Montreal, Quebec, Canada; 2Centre hospitalier de l’Université de Montréal, Montreal, Quebec, Canada; 3CHUM, Montreal, Quebec, Canada; 4Glenfield Hospital, University Hospitals of Leicester, UK; 5 CHUM, Montreal, Quebec, Canada BACKGROUND Imaging is of great relevance during all phases of left atrial appendage occlusion (LAAO). General anesthesia required by transesophageal echocardiography (TEE) can be avoided with intracardiac echocardiography (ICE) guidance. However, ICE-guided LAAO experience is limited. Our aim was to demonstrate the utility and safety of ICE from the left atrium (LA) in providing adequate imaging guidance during Amplatzer Cardiac Plug (ACP)TM and second generation AmuletTM (St.Jude Medical Inc. St.Paul’s MN) implantation. METHODS From October 2012 to June 2016 in a single Montreal center, ICE-guided percutaneous LAAO with ACP or Amulet was performed in 51 patients, the ICE catheter being placed in the LA through a second transseptal puncture. Baseline characteristics, procedural and follow-up data were prospectively recorded. TEE and clinical follow-up was performed at 3 months. Procedural success was defined as peridevice residual leak <3 mm. RESULTS LAAO was performed in 51 nonvalvular atrial fibrillation patients with long-term oral anticoagulant contraindication. Mean age was 74.4 7.6 years (range, 60-92 y). Mean CHADS2, CHA2DS-VASc and HASBLED scores were 3.61.4, 4.91.3 and 3.91.0, respectively. Success rate of device implantation was 98%. Median total procedural time was 90 min (IQR 77:116) and average amount of contrast used 14864 mL. In 80.4% of procedures, the first selected device was implanted. In all cases, ICE provided adequate procedural guidance. There was no procedural stroke, device embolization or ICE-related complication. Major complications occurred in 2 patients: tamponade needing surgical repair and silent myocardial infarction. Three patients had access site hematomas. Median hospital stay was 1 day. At 3 months follow-up, successful LAAO was observed in 50 of the 51 patients. No stroke occurred and three patients died during the followup period, all were non-procedure related deaths. CONCLUSION This pilot experience suggests that ICE from the LA was able to perform the tasks typically provided by TEE during ACP or Amulet device implantation. ICE avoids general anesthesia and is a safe and useful ultrasound option for guidance of LAAO. CATEGORIES STRUCTURAL: Left Atrial Appendage Exclusion TCT-620 A comparison of clinical outcomes between triple antithrombotic therapy versus dual antiplatelet with left atrial appendage occlusion in patients with atrial fibrillation undergoing drug-eluting stent implantation Seung Hun Lee,1 Jae Young Cho,2 Hyung Joon Joo,3 Jae Hyoung Park,4 Soonjun Hong,5 Cheol Woong Yu,6 Do Sun Lim 7 1 Anam Hospital, Korea University Medical Center., Seoul, Korea, Republic of; 2Korea University Cardiovascular center, Seoul, Korea, Republic of; 3Korea University Anam Hospital, Seoul, Korea, Republic of; 4Korea University Anam Hospital, Seoul, Korea, Republic of; 5Korea University College fo Medicine, Seoul, Korea, Republic of; 6Korean University Anam Hospital, Seoul, Korea, Republic of; 7Korea University Anam Hospital, Seoul, Korea, Republic of BACKGROUND There have been debates about optimal antithrombotic therapy for patients with atrial fibrillation (AF) undergoing drug-eluting stent (DES) implantation. We compared clinical outcomes between triple antithrombotic therapy (TATT) versus dual antiplatelet therapy (DAPT) with left atrial appendage occlusion (LAAO) in patients with AF undergoing DES implantation. METHODS We analyzed total 461 patients with AF who undergoing DES implantation from June 2006 to June 2014. Among 461 patients, we identified 151 patients with TATT. We did matched-analysis between 151 TATT and 27 patients with DAPT after LAAO. Primary end point was a net clinical outcomes, defined as a composite of all-cause death, myocardial infarction, transient ischemic attack or stroke and major bleeding.