INTELLANAV OI
Report
- Report Number
- 2134265-2021-02390
- Event Type
- Injury
- Date Received
- February 25, 2021
- Date of Event
- February 1, 2020
- Report Date
- March 3, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OAE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
B.3. DATE OF EVENT: EVENT DATE IS UNKNOWN, ARTICLE PUBLISHED 2020-02. E.1. INITIAL REPORTER FACILITY NAME: (B)(6) CENTER. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. F.10. PATIENT CODES: CORRECTED TO ADD EMBOLISM/EMBOLUS E0503.
NAKAMURA K, SASAKI T, TAKE Y, MINAMI K, INOUE M, KISHI S, YOSHIMURA S, SASAKI W, OKAZAKI Y, MOTODA H, NIIJIMA K, MIKI Y, GOTO K YAMASHITA E, KOYAMA K, FUNABASHI N, NAITO S. IMPACT OF THE TYPE OF ELECTROANATOMIC MAPPING SYSTEM ON THE INCIDENCE OF CEREBRAL EMBOLISM AFTER RADIOFREQUENCY CATHETER ABLATION OF LEFT ATRIAL TACHYCARDIAS. HEART RHYTHM. 2020; 17 (2): 250-257. BACKGROUND LEFT ATRIAL TACHYCARDIAS (ATS) OFTEN OCCUR AFTER LEFT ATRIAL ABLATION. THE INCIDENCE OF SYMPTOMATIC AND SILENT CEREBRAL EMBOLISM AFTER RADIOFREQUENCY CATHETER ABLATION (RFCA) OF LEFT ATS AND THE IMPACT OF THE TYPE OF 3-DIMENSIONAL ELECTROANATOMIC MAPPING (3D-EAM) SYSTEM ON THE INCIDENCE OF CEREBRAL EMBOLISM REMAIN UNCLEAR. OBJECTIVES THIS STUDY AIMED TO INVESTIGATE THE INCIDENCE OF CEREBRAL EMBOLISM AFTER A 3D-EAM SYSTEM-GUIDED LEFT AT ABLATION PROCEDURE AND COMPARE THAT BETWEEN THE DIFFERENT 3D-EAM SYSTEMS. METHODS WE PROSPECTIVELY ENROLLED 59 PATIENTS WHO UNDERWENT LEFT AT ABLATION AND BRAIN MAGNETIC RESONANCE IMAGING AFTER THE PROCEDURE RESULTS ONE TRANSIENT ISCHEMIC ATTACK OCCURRED IN GROUP R, AND NO SYMPTOMATIC EMBOLISM OCCURRED IN GROUP C. SILENT CEREBRAL ISCHEMIC LESIONS (SCILS) WERE OBSERVED IN 35 PATIENTS (59.3%), AND GROUP R HAD A SIGNIFICANTLY HIGHER INCIDENCE OF SCILS THAN DID GROUP C (86.2% VS 33.3%; P , .001). IN MULTIVARIATE ANALYSIS, GROUP R AND LEFT ATRIAL LINEAR ABLATION WERE INDEPENDENT POSITIVE PREDICTORS OF SCILS (ODDS RATIO 12.822 AND 8.668; P5 .001 AND P 5 .005). THE INCIDENCE OF BLEEDING COMPLICATIONS WAS COMPARABLE BETWEEN GROUPS R AND C (0% VS 3.3%; P 5 .508). CONCLUSION GROUP R EXHIBITED A HIGHER INCIDENCE OF POST ABLATION CEREBRAL EMBOLISM THAN DID GROUP C. THE USE OF THE HIGH-RESOLUTION 3D-EAM SYSTEM WITH A MINI-BASKET CATHETER TO GUIDE RADIOFREQUENCY ABLATION OF LEFT ATRIAL MACROREENTRANT TACHYCARDIAS MAY MARKEDLY INCREASE THE RISK OF SILENT CEREBRAL EMBOLISM. THE PRESENT RESULTS REQUIRE FURTHER VALIDATION IN A RANDOMIZED STUDY. METHODS STUDY POPULATION THIS STUDY PROSPECTIVELY ENROLLED 59 PATIENTS WHO UNDERWENT 3D-EAM SYSTEM-GUIDED RFCA OF PERSISTENT LEFT ATS AND BRAIN MAGNETIC RESONANCE (MR) IMAGING AFTER THE ABLATION PROCEDURE AT GUNMA PREFECTURAL CARDIOVASCULAR CENTER. RHYTHMIA-GUIDED RFCA WAS PERFORMED IN 29 PATIENTS (GROUP R) FROM OCTOBER 2016 TO MAY 2019 AND GUIDED RFCA IN 30 PATIENTS (GROUP C) FROM OCTOBER 2014 TO JANUARY 2019. STUDY SUBJECTS WERE NOT RANDOMLY ASSIGNED TO EACH 3D-EAM SYSTEM GROUP, AND WHICH 3D-EAM SYSTEM TO USE WAS DETERMINED AT THE OPERATOR'S DISCRETION. THE EXCLUSION CRITERIA FOR THIS STUDY WERE AGE YOUNGER THAN 20 YEARS, ATS THAT ORIGINATED FROM THE RIGHT ATRIUM ONLY, ABSENCE OF CLINICAL ATS AT THE BEGINNING OF THE ELECTROPHYSIOLOGY STUDIES AND ABLATION PROCEDURES, PRESENCE OF ANY INTRACARDIAC THROMBI, AND ABSOLUTE AND RELATIVE CONTRAINDICATIONS TO MR IMAGING, INCLUDING THE PRESENCE OF METALLIC IMPLANTS AND SEVERE CLAUSTROPHOBIA. ALL PATIENTS UNDERWENT TRANSESOPHAGEAL ECHOCARDIOGRAPHY TO RULE OUT ANY INTRACARDIAC THROMBI ON THE DAY OF THE ABLATION PROCEDURE OR THE DAY BEFORE. THE STUDY PROTOCOL WAS APPROVED BY THE LOCAL ETHICS COMMITTEE, AND ALL PATIENTS PROVIDED WRITTEN INFORMED CONSENT FOR PARTICIPATION. RADIOFREQUENCY CATHETER ABLATION (RFCA) DEEP CONSCIOUS SEDATION WAS MAINTAINED THROUGHOUT THE PROCEDURE USING PROPOFOL OR DEXMEDETOMIDINE AS WELL AS PENTAZOCINE. A MULTIELECTRODE CATHETER WAS POSITIONED IN THE CORONARY SINUS VIA THE RIGHT FEMORAL VEIN. AN ABLATION CATHETER, DECAPOLAR CIRCULAR MAPPING CATHETER, AND MULTIELECTRODE MAPPING CATHETER WERE INTRODUCED INTO THE LEFT ATRIUM THROUGH THE 3 TRANSSEPTAL SHEATHS. ALL ACTIVATION MAPS DURING CLINICAL ATS WERE CREATED USING THE RHYTHMIA SYSTEM USING A MINI-BASKET CATHETER (ORION, BOSTON SCIENTIFIC) OR A NON-BOSTON SCIENTIFIC SYSTEM USING A MULTISPLINE CATHETER. MAPPING CATHETERS WERE CONTINUOUSLY INFUSED WITH HEPARINIZED SALINE AT A RATE OF 20 ML/H. A LINEAR ABLATION PROCEDURE WAS PERFORMED IF AT HAD A MACROREENTRANT MECHANISM, WHILE A FOCAL OR SMALL AREA ABLATION PROCEDURE WAS PERFORMED IF AT HAD A FOCAL OR MICROREENTRANT MECHANISM. EACH APPLICATION OF RADIOFREQUENCY (RF) ENERGY WAS DELIVERED WITH A MAXIMUM RF POWER OUTPUT OF 40 W, A DURATION OF 60 SECONDS, AND A TEMPERATURE OF 42 C BY USING NONCONTACT FORCE (CF)-SENSING ABLATION CATHETERS WITH AN IRRIGATION FLOW RATE OF 8 OR 15 ML/MIN (NON-BOSTON SCIENTIFIC CATHETERS OR INTELLANAV OPEN-IRRIGATED ABLATION CATHETER) IN GROUP R AND USING CF-SENSING ABLATION CATHETERS WITH AN IRRIGATION FLOW RATE OF 17 OR 30 ML/MIN OR 8 OR 15 ML/IN IN GROUP C. IF CLINICAL AT CHANGED TO ANOTHER AT AFTER THE ABLATION PROCEDURE OR ANOTHER AT WAS INDUCED BY ATRIAL PACING AFTER CLINICAL AT WAS TERMINATED BY THE ABLATION PROCEDURE, OTHER AT WAS SUBSEQUENTLY MAPPED AND ABLATED. THE END POINT OF AT ABLATION WAS THE NONINDUCIBILITY OF ANY ATS AND, FOR MACROREENTRANT ATS, BIDIRECTIONAL CONDUCTION BLOCK ALONG THE LINEAR ABLATION LESIONS. ALL THE PULMONARY VEINS (PVS) WITH ELECTRICAL RECONNECTIONS WERE RE-ISOLATED IN PATIENTS WITH PREVIOUS PERCUTANEOUS CATHETER-BASED OR SURGICAL CRYOTHERMAL PV ISOLATION. IF AF SPONTANEOUSLY OCCURRED OR WAS INDUCED BY ATRIAL PACING AND/OR ISOPROTERENOL INFUSION DURING THE PROCEDURE, ABLATION TARGETING NON-PV FOCI, SUBSTRATE MODIFICATION OF AF INCLUDING CONTINUOUS FRACTIONATED ATRIAL ELECTROGRAM ABLATION AND/OR LINEAR ABLATION, OR ELECTRICAL CARDIOVERSION TO RESTORE SINUS RHYTHM WAS PERFORMED. PERIPROCEDURAL ANTICOAGULATION ALL PATIENTS RECEIVED PERIPROCEDURAL ORAL ANTICOAGULATION WITH WARFARIN OR DIRECT ORAL ANTICOAGULANTS (DOACS). WARFARIN WAS CONTINUED THROUGHOUT THE PERIPROCEDURAL PERIOD AT THE ADJUSTED DOSES TO ATTAIN A THERAPEUTIC INTERNATIONAL NORMALIZED RATIO, WHICH WAS 1.6-2.6 IN PATIENTS 70 YEARS AND OLDER AND 2.0-3.0 IN THOSE YOUNGER THAN 70 YEARS. 22 DOACS WERE CONTINUED THROUGHOUT THE PERIPROCEDURAL PERIOD OR DISCONTINUED ONLY ON THE DAY OF THE PROCEDURE AND REINITIATED THE NEXT MORNING AFTER THE PROCEDURE. THE STANDARD OR REDUCED DOAC DOSE APPROVED IN JAPAN WAS USED: DABIGATRAN AT A DOSE OF 110 OR 150 MG TWICE DAILY, RIVAROXABAN AT 10 OR 15 MG ONCE DAILY IN THE MORNING, APIXABAN AT 2.5 OR 5 MG TWICE DAILY, OR EDOXABAN AT 30 OR 60 MG ONCE DAILY IN THE MORNING. NEITHER LOW-MOLECULAR-WEIGHT HEPARIN NOR UNFRACTIONATED HEPARIN WAS ADMINISTERED BEFORE THE PROCEDURE. IMMEDIATELY AFTER FEMORAL VENOUS PUNCTURE DURING THE PROCEDURE, AN INITIAL HEPARIN BOLUS WAS GIVEN INTRAVENOUSLY, FOLLOWED BY A CONTINUOUS AND ADDITIONAL BOLUS HEPARIN INFUSION TO MAINTAIN THE ACTIVATED CLOTTING TIME BETWEEN 300 AND 400 SECONDS. THE INTRAVENOUS HEPARIN ADMINISTRATION WAS DISCONTINUED ONCE AT THE END OF THE PROCEDURE AND PROTAMINE WAS GIVEN TO PARTIALLY REVERSE THE ANTICOAGULATION EFFECT OF HEPARIN AT THE OPERATOR'S DISCRETION. AFTER ACHIEVING HEMOSTASIS OF FEMORAL VENOUS PUNCTURE SITES AND VERIFYING THE ABSENCE OF ANY PERICARDIAL EFFUSION BY ECHOCARDIOGRAPHY, ALL PATIENTS RECEIVED A CONTINUOUS HEPARIN INFUSION AT A DOSE OF 10,000 U PER 24 HOURS UNTIL THE NEXT MORNING AFTER THE PROCEDURE. BRAIN MAGNETIC RESONANCE (MR) IMAGING ALL PATIENTS UNDERWENT BRAIN MR IMAGING WITH A 1.5-T MR UNIT (ACHIEVA NOVA DUAL OR INGENIA, PHILIPS MEDICAL SYSTEMS, EINTHOVEN, THE NETHERLANDS) THE NEXT DAY AFTER THE PROCEDURE. IN THE PRESENT STUDY, A NEW SILENT CEREBRAL ISCHEMIC LESION (SCIL) ASSOCIATED WITH THE ABLATION PROCEDURE WAS DEFINED AS A HYPERINTENSE LESION ON DIFFUSION-WEIGHTED IMAGING (DWI), CORRESPONDING TO A REDUCED APPARENT DIFFUSION COEFFICIENT MAP.19 PATIENTS WITH SCILS DETECTED BY INITIAL MR IMAGING UNDERWENT FOLLOW-UP MR IMAGING TO DETERMINE WHETHER SCILS DEVELOPED INTO ESTABLISHED CEREBRAL INFARCTS. ON FOLLOW-UP MR IMAGING, THE DEVELOPMENT OF DWI-POSITIVE LESIONS INTO ESTABLISHED CEREBRAL INFARCTS WAS DETERMINED ON THE BASIS OF THE PRESENCE OF CORRESPONDING FLUID-ATTENUATED INVERSION RECOVERY (FLAIR) HYPERINTENSITY, AND IN CONTRAST, A COMPLETE REVERSAL OF THE LESIONS WAS DETERMINED ON THE BASIS OF THE LACK OF CORRESPONDING FLAIR HYPERINTENSITY. THE PARAMETERS OF DIFFUSION-WEIGHTED AND FLAIR SEQUENCES HAVE BEEN PREVIOUSLY DESCRIBED IN DETAIL. ALL MR IMAGING STUDIES WERE REVIEWED BY EXPERIENCED RADIOLOGISTS BLINDED TO PATIENT CHARACTERISTICS. POST ABLATION EMBOLIC AND HEMORRHAGIC EVENTS: ONE PATIENT IN GROUP R HAD TRANSIENT DOUBLE VISION AFTER THE PROCEDURE BUT SPONTANEOUSLY RECOVERED COMPLETELY FROM THE NEUROLOGICAL ABNORMALITY. NO PATIENTS HAD ANY SYMPTOMATIC EMBOLISM IN GROUP C. BRAIN MR IMAGING WAS PERFORMED 23 +/- 5 HOURS AFTER THE PROCEDURE. SCILS WERE DETECTED BY DWI IN 35 PATIENTS (59.3%), AND GROUP R REVEALED A SIGNIFICANTLY HIGHER INCIDENCE OF SCILS THAN DID GROUP C (86.2% VS 33.3%).
DATE OF EVENT: EVENT DATE IS UNKNOWN, ARTICLE PUBLISHED 2020-02. INITIAL REPORTER FACILITY NAME:(B)(6). THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
NAKAMURA K, SASAKI T, TAKE Y, MINAMI K, INOUE M, KISHI S, YOSHIMURA S, SASAKI W, OKAZAKI Y, MOTODA H, NIIJIMA K, MIKI Y, GOTO K YAMASHITA E, KOYAMA K, FUNABASHI N, NAITO S. IMPACT OF THE TYPE OF ELECTROANATOMIC MAPPING SYSTEM ON THE INCIDENCE OF CEREBRAL EMBOLISM AFTER RADIOFREQUENCY CATHETER ABLATION OF LEFT ATRIAL TACHYCARDIAS. HEART RHYTHM. 2020; 17 (2): 250-257. BACKGROUND LEFT ATRIAL TACHYCARDIAS (ATS) OFTEN OCCUR AFTER LEFT ATRIAL ABLATION. THE INCIDENCE OF SYMPTOMATIC AND SILENT CEREBRAL EMBOLISM AFTER RADIOFREQUENCY CATHETER ABLATION (RFCA) OF LEFT ATS AND THE IMPACT OF THE TYPE OF 3-DIMENSIONAL ELECTROANATOMIC MAPPING (3D-EAM) SYSTEM ON THE INCIDENCE OF CEREBRAL EMBOLISM REMAIN UNCLEAR. OBJECTIVES THIS STUDY AIMED TO INVESTIGATE THE INCIDENCE OF CEREBRAL EMBOLISM AFTER A 3D-EAM SYSTEM-GUIDED LEFT AT ABLATION PROCEDURE AND COMPARE THAT BETWEEN THE DIFFERENT 3D-EAM SYSTEMS. METHODS WE PROSPECTIVELY ENROLLED 59 PATIENTS WHO UNDERWENT LEFT AT ABLATION AND BRAIN MAGNETIC RESONANCE IMAGING AFTER THE PROCEDURE RESULTS ONE TRANSIENT ISCHEMIC ATTACK OCCURRED IN GROUP R, AND NO SYMPTOMATIC EMBOLISM OCCURRED IN GROUP C. SILENT CEREBRAL ISCHEMIC LESIONS (SCILS) WERE OBSERVED IN 35 PATIENTS (59.3%), AND GROUP R HAD A SIGNIFICANTLY HIGHER INCIDENCE OF SCILS THAN DID GROUP C (86.2% VS 33.3%; P , .001). IN MULTIVARIATE ANALYSIS, GROUP R AND LEFT ATRIAL LINEAR ABLATION WERE INDEPENDENT POSITIVE PREDICTORS OF SCILS (ODDS RATIO 12.822 AND 8.668; P5 .001 AND P 5 .005). THE INCIDENCE OF BLEEDING COMPLICATIONS WAS COMPARABLE BETWEEN GROUPS R AND C (0% VS 3.3%; P 5 .508). CONCLUSION GROUP R EXHIBITED A HIGHER INCIDENCE OF POST ABLATION CEREBRAL EMBOLISM THAN DID GROUP C. THE USE OF THE HIGH-RESOLUTION 3D-EAM SYSTEM WITH A MINI-BASKET CATHETER TO GUIDE RADIOFREQUENCY ABLATION OF LEFT ATRIAL MACROREENTRANT TACHYCARDIAS MAY MARKEDLY INCREASE THE RISK OF SILENT CEREBRAL EMBOLISM. THE PRESENT RESULTS REQUIRE FURTHER VALIDATION IN A RANDOMIZED STUDY. METHODS STUDY POPULATION. THIS STUDY PROSPECTIVELY ENROLLED 59 PATIENTS WHO UNDERWENT 3D-EAM SYSTEM-GUIDED RFCA OF PERSISTENT LEFT ATS AND BRAIN MAGNETIC RESONANCE (MR) IMAGING AFTER THE ABLATION PROCEDURE AT GUNMA PREFECTURAL CARDIOVASCULAR CENTER. RHYTHMIA-GUIDED RFCA WAS PERFORMED IN 29 PATIENTS (GROUP R) FROM OCTOBER 2016 TO MAY 2019 AND GUIDED RFCA IN 30 PATIENTS (GROUP C) FROM OCTOBER 2014 TO JANUARY 2019. STUDY SUBJECTS WERE NOT RANDOMLY ASSIGNED TO EACH 3D-EAM SYSTEM GROUP, AND WHICH 3D-EAM SYSTEM TO USE WAS DETERMINED AT THE OPERATOR'S DISCRETION. THE EXCLUSION CRITERIA FOR THIS STUDY WERE AGE YOUNGER THAN 20 YEARS, ATS THAT ORIGINATED FROM THE RIGHT ATRIUM ONLY, ABSENCE OF CLINICAL ATS AT THE BEGINNING OF THE ELECTROPHYSIOLOGY STUDIES AND ABLATION PROCEDURES, PRESENCE OF ANY INTRACARDIAC THROMBI, AND ABSOLUTE AND RELATIVE CONTRAINDICATIONS TO MR IMAGING, INCLUDING THE PRESENCE OF METALLIC IMPLANTS AND SEVERE CLAUSTROPHOBIA. ALL PATIENTS UNDERWENT TRANSESOPHAGEAL ECHOCARDIOGRAPHY TO RULE OUT ANY INTRACARDIAC THROMBI ON THE DAY OF THE ABLATION PROCEDURE OR THE DAY BEFORE. THE STUDY PROTOCOL WAS APPROVED BY THE LOCAL ETHICS COMMITTEE, AND ALL PATIENTS PROVIDED WRITTEN INFORMED CONSENT FOR PARTICIPATION. RADIOFREQUENCY CATHETER ABLATION (RFCA). DEEP CONSCIOUS SEDATION WAS MAINTAINED THROUGHOUT THE PROCEDURE USING PROPOFOL OR DEXMEDETOMIDINE AS WELL AS PENTAZOCINE. A MULTIELECTRODE CATHETER WAS POSITIONED IN THE CORONARY SINUS VIA THE RIGHT FEMORAL VEIN. AN ABLATION CATHETER, DECAPOLAR CIRCULAR MAPPING CATHETER, AND MULTIELECTRODE MAPPING CATHETER WERE INTRODUCED INTO THE LEFT ATRIUM THROUGH THE 3 TRANSSEPTAL SHEATHS. ALL ACTIVATION MAPS DURING CLINICAL ATS WERE CREATED USING THE RHYTHMIA SYSTEM USING A MINI-BASKET CATHETER (ORION, BOSTON SCIENTIFIC) OR A NON-BOSTON SCIENTIFIC SYSTEM USING A MULTISPLINE CATHETER. MAPPING CATHETERS WERE CONTINUOUSLY INFUSED WITH HEPARINIZED SALINE AT A RATE OF 20 ML/H. A LINEAR ABLATION PROCEDURE WAS PERFORMED IF AT HAD A MACROREENTRANT MECHANISM, WHILE A FOCAL OR SMALL AREA ABLATION PROCEDURE WAS PERFORMED IF AT HAD A FOCAL OR MICROREENTRANT MECHANISM. EACH APPLICATION OF RADIOFREQUENCY (RF) ENERGY WAS DELIVERED WITH A MAXIMUM RF POWER OUTPUT OF 40 W, A DURATION OF 60 SECONDS, AND A TEMPERATURE OF 42 C BY USING NONCONTACT FORCE (CF)-SENSING ABLATION CATHETERS WITH AN IRRIGATION FLOW RATE OF 8 OR 15 ML/MIN (NON-BOSTON SCIENTIFIC CATHETERS OR INTELLANAV OPEN-IRRIGATED ABLATION CATHETER) IN GROUP R AND USING CF-SENSING ABLATION CATHETERS WITH AN IRRIGATION FLOW RATE OF 17 OR 30 ML/MIN OR 8 OR 15 ML/IN IN GROUP C. IF CLINICAL AT CHANGED TO ANOTHER AT AFTER THE ABLATION PROCEDURE OR ANOTHER AT WAS INDUCED BY ATRIAL PACING AFTER CLINICAL AT WAS TERMINATED BY THE ABLATION PROCEDURE, OTHER AT WAS SUBSEQUENTLY MAPPED AND ABLATED. THE END POINT OF AT ABLATION WAS THE NONINDUCIBILITY OF ANY ATS AND, FOR MACROREENTRANT ATS, BIDIRECTIONAL CONDUCTION BLOCK ALONG THE LINEAR ABLATION LESIONS. ALL THE PULMONARY VEINS (PVS) WITH ELECTRICAL RECONNECTIONS WERE RE-ISOLATED IN PATIENTS WITH PREVIOUS PERCUTANEOUS CATHETER-BASED OR SURGICAL CRYOTHERMAL PV ISOLATION. IF AF SPONTANEOUSLY OCCURRED OR WAS INDUCED BY ATRIAL PACING AND/OR ISOPROTERENOL INFUSION DURING THE PROCEDURE, ABLATION TARGETING NON-PV FOCI, SUBSTRATE MODIFICATION OF AF INCLUDING CONTINUOUS FRACTIONATED ATRIAL ELECTROGRAM ABLATION AND/OR LINEAR ABLATION, OR ELECTRICAL CARDIOVERSION TO RESTORE SINUS RHYTHM WAS PERFORMED. PERIPROCEDURAL ANTICOAGULATION ALL PATIENTS RECEIVED PERIPROCEDURAL ORAL ANTICOAGULATION WITH WARFARIN OR DIRECT ORAL ANTICOAGULANTS (DOACS). WARFARIN WAS CONTINUED THROUGHOUT THE PERIPROCEDURAL PERIOD AT THE ADJUSTED DOSES TO ATTAIN A THERAPEUTIC INTERNATIONAL NORMALIZED RATIO, WHICH WAS 1.6-2.6 IN PATIENTS 70 YEARS AND OLDER AND 2.0-3.0 IN THOSE YOUNGER THAN 70 YEARS. 22 DOACS WERE CONTINUED THROUGHOUT THE PERIPROCEDURAL PERIOD OR DISCONTINUED ONLY ON THE DAY OF THE PROCEDURE AND REINITIATED THE NEXT MORNING AFTER THE PROCEDURE. THE STANDARD OR REDUCED DOAC DOSE APPROVED IN JAPAN WAS USED: DABIGATRAN AT A DOSE OF 110 OR 150 MG TWICE DAILY, RIVAROXABAN AT 10 OR 15 MG ONCE DAILY IN THE MORNING, APIXABAN AT 2.5 OR 5 MG TWICE DAILY, OR EDOXABAN AT 30 OR 60 MG ONCE DAILY IN THE MORNING. NEITHER LOW-MOLECULAR-WEIGHT HEPARIN NOR UNFRACTIONATED HEPARIN WAS ADMINISTERED BEFORE THE PROCEDURE. IMMEDIATELY AFTER FEMORAL VENOUS PUNCTURE DURING THE PROCEDURE, AN INITIAL HEPARIN BOLUS WAS GIVEN INTRAVENOUSLY, FOLLOWED BY A CONTINUOUS AND ADDITIONAL BOLUS HEPARIN INFUSION TO MAINTAIN THE ACTIVATED CLOTTING TIME BETWEEN 300 AND 400 SECONDS. THE INTRAVENOUS HEPARIN ADMINISTRATION WAS DISCONTINUED ONCE AT THE END OF THE PROCEDURE AND PROTAMINE WAS GIVEN TO PARTIALLY REVERSE THE ANTICOAGULATION EFFECT OF HEPARIN AT THE OPERATOR'S DISCRETION. AFTER ACHIEVING HEMOSTASIS OF FEMORAL VENOUS PUNCTURE SITES AND VERIFYING THE ABSENCE OF ANY PERICARDIAL EFFUSION BY ECHOCARDIOGRAPHY, ALL PATIENTS RECEIVED A CONTINUOUS HEPARIN INFUSION AT A DOSE OF 10,000 U PER 24 HOURS UNTIL THE NEXT MORNING AFTER THE PROCEDURE. BRAIN MAGNETIC RESONANCE (MR) IMAGING. ALL PATIENTS UNDERWENT BRAIN MR IMAGING WITH A 1.5-T MR UNIT (ACHIEVA NOVA DUAL OR INGENIA, PHILIPS MEDICAL SYSTEMS, EINTHOVEN, THE NETHERLANDS) THE NEXT DAY AFTER THE PROCEDURE. IN THE PRESENT STUDY, A NEW SILENT CEREBRAL ISCHEMIC LESION (SCIL) ASSOCIATED WITH THE ABLATION PROCEDURE WAS DEFINED AS A HYPERINTENSE LESION ON DIFFUSION-WEIGHTED IMAGING (DWI), CORRESPONDING TO A REDUCED APPARENT DIFFUSION COEFFICIENT MAP.19 PATIENTS WITH SCILS DETECTED BY INITIAL MR IMAGING UNDERWENT FOLLOW-UP MR IMAGING TO DETERMINE WHETHER SCILS DEVELOPED INTO ESTABLISHED CEREBRAL INFARCTS. ON FOLLOW-UP MR IMAGING, THE DEVELOPMENT OF DWI-POSITIVE LESIONS INTO ESTABLISHED CEREBRAL INFARCTS WAS DETERMINED ON THE BASIS OF THE PRESENCE OF CORRESPONDING FLUID-ATTENUATED INVERSION RECOVERY (FLAIR) HYPERINTENSITY, AND IN CONTRAST, A COMPLETE REVERSAL OF THE LESIONS WAS DETERMINED ON THE BASIS OF THE LACK OF CORRESPONDING FLAIR HYPERINTENSITY. THE PARAMETERS OF DIFFUSION-WEIGHTED AND FLAIR SEQUENCES HAVE BEEN PREVIOUSLY DESCRIBED IN DETAIL. ALL MR IMAGING STUDIES WERE REVIEWED BY EXPERIENCED RADIOLOGISTS BLINDED TO PATIENT CHARACTERISTICS. POST ABLATION EMBOLIC AND HEMORRHAGIC EVENTS: ONE PATIENT IN GROUP R HAD TRANSIENT DOUBLE VISION AFTER THE PROCEDURE BUT SPONTANEOUSLY RECOVERED COMPLETELY FROM THE NEUROLOGICAL ABNORMALITY. NO PATIENTS HAD ANY SYMPTOMATIC EMBOLISM IN GROUP C. BRAIN MR IMAGING WAS PERFORMED 23 +/- 5 HOURS AFTER THE PROCEDURE. SCILS WERE DETECTED BY DWI IN 35 PATIENTS (59.3%), AND GROUP R REVEALED A SIGNIFICANTLY HIGHER INCIDENCE OF SCILS THAN DID GROUP C (86.2% VS 33.3%).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278828 | INTELLANAV OI | INTELLANAV OI | OAE | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER| INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER| INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER |