2287f652f2fbf61160e6a497bc805772 pmc_33915971.pdf ab7b8a3df8460e4aef4d8b187dbcc23c1e4a24e8 pmc_33915971.pdf 0b89c7471f696b300189e7d6c1766106ad5250e08a601ab30db59bd12f5fd1e2 pmc_33915971.pdf Title: Left Atrial Appendage Closure with a New Occluder Device: Efficacy, Safety and Mid-Term Performance Subject: The LAmbreTM device is a novel system designed for left atrial appendage closure (LAAC). First registries showed a high rate of device implantation success. However, few mid-term results are available. We present our 1- and 12-month follow-up results for this device. This prospective, single-center registry included consecutive patients with nonvalvular atrial fibrillation who underwent LAAC with the LAmbreTM device. Transesophageal echocardiography (TEE) was performed at 1-month follow-up. In total, 55 patients were included. The population was elderly (75 9.4 years), with a high proportion of comorbidities. The mean CHA2DS2-VASc and HAS-BLED scores were 4.6 1.6 and 3.9 1.0, respectively. Previous history of a major bleeding event was present in 37 patients (67.3%). Procedural success was achieved in 54 patients (98.2%). Device success was achieved in 100% of patients in whom device implantation was attempted (54 patients). Major in-hospital device-related complications included mortality of one patient (1.8%) and pericardial tamponade in two patients (3.6%); the incidence of stroke was 0%. No thrombus or significant leaks (5 mm) were observed on 1-month TEE. At 12 months, adverse events were overall death (1.8%), transient ischemic attack/ischemic stroke (1.8%), and major bleeding events (Bleeding Academic Research Consortium (BARC) 3a and 3c; 11%). In this high-risk population, the LAmbreTM device seems to be a safe and effective option for LAAC with a remarkable mid-term performance. Keywords: left atrial appendage closure; atrial fibrillation; stroke; LAmbre Author: Marc Llagostera-Martín, Hector Cubero-Gallego, Aleksandra Mas-Stachurska, Neus Salvatella, Andrea Sánchez-Carpintero, Helena Tizon-Marcos, Marcos Garcia-Guimaraes, Alicia Calvo-Fernandez, Luis Molina and Beatriz Vaquerizo Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Thu Apr 1 10:25:25 2021 CEST ModDate: Fri Apr 9 05:32:20 2021 CEST Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 11 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 10650535 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- NDNESF+URWPalladioL-Ital Type 1 Custom yes yes no 10 0 BXDSSP+URWPalladioL-Bold Type 1 Custom yes yes no 15 0 HCCOVL+URWPalladioL-Roma Type 1 Custom yes yes no 19 0 UWJUYN+CMSY10 Type 1 Builtin yes yes no 23 0 SSNIUI+VnURWPalladioL-Bold Type 1 Custom yes yes no 27 0 XPUSBJ+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 36 0 BSDWLC+TimesNewRomanPSMT Type 1C WinAnsi yes yes no 39 0 MCBCCI+SourceSansRoman-Regular Type 1C Custom yes yes no 61 0 MCBCCM+SourceSansRoman.613wght Type 1C Custom yes yes no 65 0 MCBCCO+SourceSansRoman-Bold Type 1C Custom yes yes no 69 0 IODBRE+VnURWPalladioL Type 1 Custom yes yes no 122 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2024-10-02 03:21:15 CEST RepresentationInformation: pmc_33915971.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2023-03-31 12:09:45 CEST Size: 10650535 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 236 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Materials and Methods Destination: section.2 Item: Title: Results Destination: section.3 Item: Title: Discussion Destination: section.4 Item: Title: Conclusions Destination: section.5 Item: Title: Destination: section.A. Item: Title: References Destination: specialtable.caption.10 Info: Title: Left Atrial Appendage Closure with a New Occluder Device: Efficacy, Safety and Mid-Term Performance Author: Marc Llagostera-Martín, Hector Cubero-Gallego, Aleksandra Mas-Stachurska, Neus Salvatella, Andrea Sánchez-Carpintero, Helena Tizon-Marcos, Marcos Garcia-Guimaraes, Alicia Calvo-Fernandez, Luis Molina and Beatriz Vaquerizo Subject: The LAmbreTM device is a novel system designed for left atrial appendage closure (LAAC). First registries showed a high rate of device implantation success. However, few mid-term results are available. We present our 1- and 12-month follow-up results for this device. This prospective, single-center registry included consecutive patients with nonvalvular atrial fibrillation who underwent LAAC with the LAmbreTM device. Transesophageal echocardiography (TEE) was performed at 1-month follow-up. In total, 55 patients were included. The population was elderly (75 9.4 years), with a high proportion of comorbidities. The mean CHA2DS2-VASc and HAS-BLED scores were 4.6 1.6 and 3.9 1.0, respectively. Previous history of a major bleeding event was present in 37 patients (67.3%). Procedural success was achieved in 54 patients (98.2%). Device success was achieved in 100% of patients in whom device implantation was attempted (54 patients). Major in-hospital device-related complications included mortality of one patient (1.8%) and pericardial tamponade in two patients (3.6%); the incidence of stroke was 0%. No thrombus or significant leaks (5 mm) were observed on 1-month TEE. At 12 months, adverse events were overall death (1.8%), transient ischemic attack/ischemic stroke (1.8%), and major bleeding events (Bleeding Academic Research Consortium (BARC) 3a and 3c; 11%). In this high-risk population, the LAmbreTM device seems to be a safe and effective option for LAAC with a remarkable mid-term performance. Keywords: left atrial appendage closure; atrial fibrillation; stroke; LAmbre Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Thu Apr 01 10:25:25 CEST 2021 ModDate: Fri Apr 09 05:32:20 CEST 2021 ID: 0x8f610854fc49faa37a17ffcc89fc43b0, 0x8f610854fc49faa37a17ffcc89fc43b0 Filters: FilterPipeline: FlateDecode Fonts: Type1: Font: BaseFont: HCCOVL+URWPalladioL-Roma FontSubset: true FirstChar: 2 LastChar: 246 FontDescriptor: FontName: HCCOVL+URWPalladioL-Roma Flags: Symbolic FontBBox: -166, -283, 1021, 943 FontFile: true EncodingDictionary: Differences: true Font: BaseFont: UWJUYN+CMSY10 FontSubset: true FirstChar: 0 LastChar: 21 FontDescriptor: FontName: UWJUYN+CMSY10 Flags: Symbolic FontBBox: -29, -960, 1116, 775 FontFile: true Font: BaseFont: NDNESF+URWPalladioL-Ital FontSubset: true FirstChar: 45 LastChar: 241 FontDescriptor: FontName: NDNESF+URWPalladioL-Ital Flags: Symbolic FontBBox: -170, -305, 1010, 941 FontFile: true EncodingDictionary: Differences: true Font: BaseFont: IODBRE+VnURWPalladioL FontSubset: true FirstChar: 150 LastChar: 226 FontDescriptor: FontName: IODBRE+VnURWPalladioL Flags: Symbolic FontBBox: -166, -283, 1021, 943 FontFile: true EncodingDictionary: Differences: true Font: BaseFont: SSNIUI+VnURWPalladioL-Bold FontSubset: true FirstChar: 161 LastChar: 189 FontDescriptor: FontName: SSNIUI+VnURWPalladioL-Bold Flags: Symbolic FontBBox: -152, -301, 1000, 935 FontFile: true EncodingDictionary: Differences: true Font: BaseFont: BXDSSP+URWPalladioL-Bold FontSubset: true FirstChar: 2 LastChar: 122 FontDescriptor: FontName: BXDSSP+URWPalladioL-Bold Flags: Symbolic FontBBox: -152, -301, 1000, 935 FontFile: true EncodingDictionary: Differences: true Pages: Page: Sequence: 1 Annotations: Annotation: Subtype: Link Rect: 35, 759, 176, 795 Annotation: Subtype: Link Rect: 515, 759, 560, 795 Annotation: Subtype: Link Rect: 149, 659, 160, 673 Annotation: Subtype: Link Rect: 283, 647, 295, 661 Annotation: Subtype: Link Rect: 240, 634, 251, 648 Annotation: Subtype: Link Rect: 54, 370, 154, 379 Annotation: Subtype: Link Rect: 35, 358, 75, 367 Annotation: Subtype: Link Rect: 35, 162, 97, 184 Annotation: Subtype: Link Rect: 153, 89, 154, 98 Annotation: Subtype: Link Rect: 35, 77, 147, 86 Annotation: Subtype: Link Rect: 474, 210, 481, 219 ActionDest: 119 Annotation: Subtype: Link Rect: 448, 185, 455, 194 ActionDest: 119 Annotation: Subtype: Link Rect: 455, 185, 462, 194 ActionDest: 119 Annotation: Subtype: Link Rect: 523, 160, 530, 169 ActionDest: 119 Annotation: Subtype: Link Rect: 530, 160, 537, 169 ActionDest: 119 Annotation: Subtype: Link Rect: 266, 122, 272, 131 ActionDest: 119 Annotation: Subtype: Link Rect: 276, 122, 283, 131 ActionDest: 119 Annotation: Subtype: Link Rect: 228, 85, 235, 94 ActionDest: 119 Annotation: Subtype: Link Rect: 238, 85, 245, 94 ActionDest: 119 Annotation: Subtype: Link Rect: 131, 17, 268, 28 Annotation: Subtype: Link Rect: 422, 17, 558, 28 Annotation: Subtype: Link Rect: 35, 506, 87, 525 Page: Sequence: 2 Annotations: Annotation: Subtype: Link Rect: 370, 724, 377, 733 ActionDest: 126 Annotation: Subtype: Link Rect: 467, 674, 478, 683 ActionDest: 126 Annotation: Subtype: Link Rect: 482, 674, 494, 683 ActionDest: 126 Annotation: Subtype: Link Rect: 438, 385, 450, 394 ActionDest: 126 Annotation: Subtype: Link Rect: 370, 335, 382, 344 ActionDest: 126 Annotation: Subtype: Link Rect: 488, 319, 495, 331 ActionDest: 81 Annotation: Subtype: Link Rect: 256, 269, 263, 281 ActionDest: 81 Page: Sequence: 3 Page: Sequence: 4 Annotations: Annotation: Subtype: Link Rect: 251, 619, 258, 631 ActionDest: 81 Annotation: Subtype: Link Rect: 510, 509, 522, 518 ActionDest: 126 Annotation: Subtype: Link Rect: 325, 471, 337, 480 ActionDest: 126 Annotation: Subtype: Link Rect: 200, 346, 212, 355 ActionDest: 126 Annotation: Subtype: Link Rect: 381, 230, 388, 242 ActionDest: 98 Annotation: Subtype: Link Rect: 409, 230, 416, 242 ActionDest: 101 Annotation: Subtype: Link Rect: 506, 230, 513, 242 ActionDest: 98 Annotation: Subtype: Link Rect: 405, 142, 412, 154 ActionDest: 101 Annotation: Subtype: Link Rect: 239, 79, 246, 91 ActionDest: 101 Page: Sequence: 5 Annotations: Annotation: Subtype: Link Rect: 408, 84, 414, 96 ActionDest: 110 Page: Sequence: 6 Page: Sequence: 7 Annotations: Annotation: Subtype: Link Rect: 515, 669, 530, 681 ActionDest: 119 Annotation: Subtype: Link Rect: 212, 657, 222, 669 ActionDest: 119 Annotation: Subtype: Link Rect: 552, 381, 559, 393 ActionDest: 110 Annotation: Subtype: Link Rect: 191, 164, 198, 176 ActionDest: 113 Annotation: Subtype: Link Rect: 298, 127, 305, 139 ActionDest: 119 Annotation: Subtype: Link Rect: 381, 127, 391, 139 ActionDest: 119 Page: Sequence: 8 Annotations: Annotation: Subtype: Link Rect: 497, 409, 504, 418 ActionDest: 119 Annotation: Subtype: Link Rect: 505, 409, 512, 418 ActionDest: 119 Annotation: Subtype: Link Rect: 512, 409, 524, 418 ActionDest: 126 Annotation: Subtype: Link Rect: 527, 409, 539, 418 ActionDest: 126 Annotation: Subtype: Link Rect: 430, 397, 442, 406 ActionDest: 126 Annotation: Subtype: Link Rect: 445, 397, 457, 406 ActionDest: 126 Annotation: Subtype: Link Rect: 457, 397, 469, 406 ActionDest: 126 Annotation: Subtype: Link Rect: 197, 334, 209, 343 ActionDest: 126 Annotation: Subtype: Link Rect: 212, 334, 224, 343 ActionDest: 126 Annotation: Subtype: Link Rect: 225, 334, 237, 343 ActionDest: 126 Annotation: Subtype: Link Rect: 438, 271, 450, 280 ActionDest: 126 Annotation: Subtype: Link Rect: 431, 196, 443, 205 ActionDest: 126 Annotation: Subtype: Link Rect: 444, 196, 456, 205 ActionDest: 126 Annotation: Subtype: Link Rect: 372, 183, 384, 192 ActionDest: 126 Annotation: Subtype: Link Rect: 281, 145, 293, 155 ActionDest: 126 Annotation: Subtype: Link Rect: 500, 120, 512, 129 ActionDest: 126 Annotation: Subtype: Link Rect: 196, 108, 208, 117 ActionDest: 126 Page: Sequence: 9 Annotations: Annotation: Subtype: Link Rect: 357, 685, 369, 694 ActionDest: 126 Annotation: Subtype: Link Rect: 503, 660, 515, 669 ActionDest: 126 Annotation: Subtype: Link Rect: 510, 634, 522, 643 ActionDest: 126 Annotation: Subtype: Link Rect: 236, 484, 248, 493 ActionDest: 126 Page: Sequence: 10 Annotations: Annotation: Subtype: Link Rect: 104, 299, 142, 309 Annotation: Subtype: Link Rect: 148, 299, 184, 309 Annotation: Subtype: Link Rect: 158, 218, 196, 229 Annotation: Subtype: Link Rect: 202, 218, 238, 229 Annotation: Subtype: Link Rect: 95, 184, 133, 194 Annotation: Subtype: Link Rect: 312, 148, 350, 159 Annotation: Subtype: Link Rect: 122, 115, 160, 125 Annotation: Subtype: Link Rect: 386, 79, 424, 90 Annotation: Subtype: Link Rect: 404, 56, 442, 67 Page: Sequence: 11 Annotations: Annotation: Subtype: Link Rect: 448, 732, 485, 743 Annotation: Subtype: Link Rect: 517, 709, 554, 720 Annotation: Subtype: Link Rect: 478, 686, 515, 697 Annotation: Subtype: Link Rect: 263, 652, 301, 663 Annotation: Subtype: Link Rect: 220, 630, 257, 640 Annotation: Subtype: Link Rect: 468, 606, 505, 617 Annotation: Subtype: Link Rect: 511, 606, 547, 617 Annotation: Subtype: Link Rect: 326, 571, 362, 582 Annotation: Subtype: Link Rect: 239, 538, 276, 548 Annotation: Subtype: Link Rect: 282, 538, 318, 548 Annotation: Subtype: Link Rect: 479, 502, 516, 513 Annotation: Subtype: Link Rect: 521, 502, 557, 513 Annotation: Subtype: Link Rect: 511, 468, 548, 479 Annotation: Subtype: Link Rect: 276, 434, 314, 444 Annotation: Subtype: Link Rect: 520, 399, 557, 410 Annotation: Subtype: Link Rect: 257, 365, 294, 375 Annotation: Subtype: Link Rect: 301, 365, 337, 375 Annotation: Subtype: Link Rect: 317, 331, 354, 341 Annotation: Subtype: Link Rect: 360, 331, 396, 341 Annotation: Subtype: Link Rect: 156, 308, 194, 318 Annotation: Subtype: Link Rect: 200, 308, 236, 318 Checksum: b5d5e666 Type: CRC32 Checksum: 2287f652f2fbf61160e6a497bc805772 Type: MD5 Checksum: ab7b8a3df8460e4aef4d8b187dbcc23c1e4a24e8 Type: SHA-1 Checksum: 0b89c7471f696b300189e7d6c1766106ad5250e08a601ab30db59bd12f5fd1e2 Type: SHA-256