BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS VALVE SYSTEM

    MDR report key: 11818933 · Received May 13, 2021

    Report

    Report Number
    2134265-2021-05725
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    January 1, 2013
    Report Date
    May 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT - APPROXIMATE. EVENTS OCCURRED BETWEEN 2013 AND 2015. LITERATURE CITATION: HILLING-SMITH R, KEMP T, DOOLEY M, RAMPAT R, DE BELDER A, HILL A, COCKBURN J, TRIVEDI U, HILDICK-SMITH D, HOMSY M. PREDICTING THE NEED FOR PERMANENT PACING AFTER IMPLANTATION OF THE REPOSITIONABLE LOTUS TRANSCATHETER AORTIC VALVE. J INVASIVE CARDIOL. 2020; 32 (9): 347-9. RETRIEVED FROM HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/32653863.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ARTICLE THAT ARRHYTHMIAS OCCURRED. THE AUTHORS ANALYZED THE BASELINE CHARACTERISTICS, AND THEN THE PREPROCEDURAL AND DAILY POST PROCEDURE ELECTROCARDIOGRAMS (ECGS) OF 101 CONSECUTIVE PATIENTS WHO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) USING THE LOTUS VALVE SYSTEM BETWEEN 2013 AND 2015. LITERATURE RESULTS: MEAN PATIENT AGE WAS 81.7 +/- 7.7 YEARS, 56% OF PATIENTS WERE MALE. TWENTY ONE (21) PATIENTS WERE EXCLUDED BECAUSE OF BASELINE ATRIAL FIBRILLATION OR A PRE-EXISTING PERMANENT PACEMAKER IMPLANTATION (PPI). OF THE REMAINING 80 PATIENTS, A TOTAL OF 28 (35%) UNDERWENT PPI AT A MEAN 2.7 DAYS AFTER TAVI. NO PATIENTS WHO WERE IN SINUS RHYTHM BEFORE THE PROCEDURE DEVELOPED ATRIAL FIBRILLATION. NINE PATIENTS (11.3%) DEVELOPED PROCEDURAL COMPLETE HEART BLOCK; 8 OF THESE HAD SUBSEQUENT PPI, 1 OF WHOM DEVELOPED RESTORATION OF SINUS RHYTHM. AMONG THE REMAINING 71 PATIENTS, PREPROCEDURAL PR INTERVAL OF THE ELECTROCARDIOGRAM WAS SIMILAR BETWEEN THE TWO GROUPS. THE IMMEDIATE POST PROCEDURE ECGS OF THOSE WHO WENT ON TO HAVE PPI HAD A PR INTERVAL THAT WAS NOT STATISTICALLY ELONGATED. INDICATIONS FOR THE PPI IN THE POST-TAVI PERIOD WERE: COMPLETE ATRIOVENTRICULAR BLOCK (N=17), PROLONGED FIRST-DEGREE ATRIOVENTRICULAR BLOCK WIT LEFT BUNDLE BRANCH BLOCK (N=9) AND ATRIAL FIBRILLATION WITH SLOW VENTRICULAR RESPONSE (N=2) THERE WERE NO DIFFERENCES IN DEVELOPMENT OF NEW LEFT BUNDLE-BRANCH BLOCK BETWEEN THE TWO GROUPS (65% PPI GROUP VS 74% NO-PPI GROUP; P=.37). THE PR INTERVAL INCREASED BY DAY 1 POST PROCEDURE (232 MS PPI GROUP VS 195 MS NO-PPI GROUP; P<.01) AND DAY 2 (267 MS PPI GROUP VS 211 MS NO-PPI GROUP; P<.05). LITERATURE CONCLUSION: THE NEED FOR PPI IS A COMMON CONSEQUENCE OF TAVI. IN PATIENTS RECEIVING A LOTUS VALVE DEVICE, THERE IS A VERY LOW RISK OF PPI REQUIREMENT IF THE PR INTERVAL ON DAY 1 IS <230MS, REGARDLESS OF QRS DURATION. THOSE >230MS REQUIRE MONITORING UNTIL DAY 3, BY WHICH TIME THOSE REQUIRING PPI HAVE "DECLARED" THEMSELVES BY RISING PR INTERVAL OR HIGHER DEGREES OF ATRIOVENTRICULAR BLOCK. THIS MAY FACILITATE EARLY DISCHARGE, WHICH IS OF INCREASING SIGNIFICANCE AS TAVI IS EXTENDED TO A LOWER-RISK COHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715953 LOTUS VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention