The Experts below are selected from a list of 9216 Experts worldwide ranked by ideXlab platform
Janice Macleod - One of the best experts on this subject based on the ideXlab platform.
-
219 or impact of inpen smart insulin pen use on real world glycemic and insulin dosing outcomes in individuals with poorly controlled diabetes
Diabetes, 2021Co-Authors: Robert A Vigersky, Toni L Cordero, Madison Smith, Sneha Thanasekaran, Angela Gaetano, Janice MacleodAbstract:Background: Smart insulin pens that track the timing and amount of insulin administration, communicate with phone apps that provide bolus calculators and integrate CGM data are emerging as important technology for users of multiple daily injections (MDI) therapy, as they can improve glycemic outcomes and be more cost-effective compared to some standards of care.1,2 Early real-world outcomes of InPen™ smart insulin pen users were assessed in the present study. Methods: Deidentified CGM-derived data from N=1736 individuals before and up to 90 days after starting InPen use between Jan. 2018 to Oct. 2020 were evaluated. Glycemic outcomes including mean sensor glucose (SG), glucose management indicator (GMI), and percentage of time spent between 70-180mg/dL (TIR), >180mg/dL (TAR) and Results: Compared to pre-InPen use, individuals (N=423) with suboptimal baseline glycemic control (GMI >8.0%) had increased TIR (+2.3%, 0.6h/day); and reduced GMI (-0.1%), SG (-4.3mg/dL) and TAR (-2.4%); with no change in TBR. Those with poorest glycemic control at baseline (GMI >9.5, N=106) had TIR that improved by +5.0% (1.2h/day), GMI by -0.4%, SG by -14.9mg/dL, and TAR by -5.1% (-1.2h/day), with no change in TBR. From the first month to 90-days post-InPen use, average daily insulin bolus frequency decreased (from 3.7 to 3.6/day and 3.3 to 3.2/day, respectively, for each group) and total rapid acting daily dose of insulin increased (from 26.29 to 27.19 u/day and 27.57 to 29.24 u/day, respectively, for each group). All results were significant at p Discussion: These data show that InPen use is associated with improved glycemic control and increased doses of bolus insulin in users with poor glycemic control. 1. Jendle J, Ericsson A, Gundgaard J, et al. Diabetes Ther. 2020; doi: 10.1007/s13300-020-00980-1. 2. Adolfsson P, Hartvig NV, Kaas A, rt al. Diabetes Technol Ther;2020;22:709-718. Disclosure R. Vigersky: Employee; Self; Medtronic. M. Smith: Employee; Self; Companion Medical, Medtronic. S. Thanasekaran: Employee; Self; Companion Medical, Medtronic. A. Gaetano: Employee; Self; Companion Medical, Medtronic. G. Im: Employee; Self; Companion Medical, Medtronic. T. L. Cordero: Employee; Self; Medtronic. J. Macleod: Employee; Self; Companion Medical, Medtronic.
-
713 p glycemic outcomes of new inpen smart insulin pen users who received virtual onboarding support
Diabetes, 2021Co-Authors: Madison Smith, Sneha Thanasekaran, Angela Gaetano, Janice MacleodAbstract:Background and Aims: The InPen™ smart insulin pen is FDA-cleared for self-start therapy from home due to its simplicity and ease of setup. New users were offered virtual onboarding support that included a personalized review, optimization of key features, and benefits of use (e.g., dose calculator, active insulin, in-app reminders, and report generation). This study assessed glycemic outcomes achieved by users who received onboarding support and users who did not. Methods: InPen™ users (N=2,534) with ≥30 days of distinct InPen™ and CGM data were categorized into one of three groups based on virtual onboarding support provided from April-August 2020: A. No support, unable to reach, B. Basic tech support, declined onboarding and C. Onboarding support. Glycemic outcomes (GMI, CV, TIR, TAR, and TBR) were compared and analyzed using ANOVA testing. Results: Table 1 shows that users who received virtual onboarding support (Group C) demonstrated significantly improved glycemic outcomes when compared to users who did not (Group A). No difference was observed in TBR across all groups. Conclusions: Future efforts should evaluate methods that increase device and feature engagement during the self-start and onboarding processes to optimize diabetes self-management behaviors and glycemic control. Disclosure M. Smith: Employee; Self; Companion Medical, Medtronic. G. Im: Employee; Self; Companion Medical, Medtronic. A. Gaetano: Employee; Self; Companion Medical, Medtronic. S. Thanasekaran: Employee; Self; Companion Medical, Medtronic. J. Macleod: Employee; Self; Companion Medical, Medtronic.
Patrick W Serruys - One of the best experts on this subject based on the ideXlab platform.
-
prosthesis patient mismatch after transcatheter aortic valve implantation with the Medtronic corevalve system in patients with aortic stenosis
American Journal of Cardiology, 2010Co-Authors: Apostolos Tzikas, Nicolas M Van Mieghem, Rutgerjan Nuis, Nicolo Piazza, Carl Schultz, Robert Jan Van Geuns, Marcel L Geleijnse, Tjebbe W Galema, Arie Pieter Kappetein, Patrick W SerruysAbstract:A prosthesis–patient mismatch (PPM) is present when the prosthetic valve is too small in relation to the patient's body size. The purpose of the present study was to investigate the frequency of PPM after the implantation of the Medtronic CoreValve System, and its relation to the clinical outcome. The indexed effective orifice area (EOA) was measured in 74 patients with symptomatic severe aortic stenosis, who had undergone successful transcatheter aortic valve implantation with the Medtronic CoreValve System, at baseline and discharge. PPM was defined as severe (indexed EOA 2 /m 2 ) or moderate (indexed EOA 0.65 to 0.85 cm 2 /m 2 ). The indexed EOA increased from 0.35 ± 0.13 to 0.97 ± 0.34 cm 2 /m 2 after transcatheter aortic valve implantation (p 2 /m 2 , p
-
vascular complications with transcatheter aortic valve implantation using the 18 fr Medtronic corevalve system the rotterdam experience
Eurointervention, 2010Co-Authors: Nicolas M Van Mieghem, Rutgerjan Nuis, Nicolo Piazza, Apostolos Tzikas, Jurgen Ligthart, Carl Schultz, Peter De Jaegere, Patrick W SerruysAbstract:textabstractAims: Transcatheter aortic valve implantation (TAVI) requires large bore catheters. Access site complications, therefore, can be a concern. The aim of this study is to present the 30-day incidence of major and minor vascular complications in patients treated with the third generation 18 Fr Medtronic CoreValve System®. Methods and results: We prospectively evaluated the vascular complications occurring in all patients treated with the 18 Fr Medtronic CoreValve System® between October 2006 and October 2009 in the Thoraxcenter using various proposed definitions. Ninety-nine consecutive patients were treated with TAVI using the 18 Fr Medtronic CoreValve System®. Vascular events were encountered in 13 patients (13%), seven of these cases (54%) were related to incomplete arteriotomy closure with the Prostar device which is the default access closure technique in our centre. Depending on how major vascular complications were defined, the incidence varied from 4 to 13%. Blood transfusions in combination with surgical or percutaneous intervention were required in eight cases. Conclusions: Transcatheter aortic valve implantation with the 18 Fr Medtronic CoreValve System® has a 4 to 13% vascular complications' rate. More than half of the vascular events were due to incomplete Prostar arteriotomy closure, despite its use by experienced operators. Current percutaneous closure devices for these large arteriotomies seems suboptimal. Uniformity in how to define TAVI related vascular complications is needed.
-
geometry and degree of apposition of the corevalve revalving system with multislice computed tomography after implantation in patients with aortic stenosis
Journal of the American College of Cardiology, 2009Co-Authors: Carl Schultz, Nicolo Piazza, Patrick W Serruys, Annick C Weustink, Amber Otten, Nico R Mollet, Gabriel P Krestin, Robert Jan Van Geuns, Pim J De Feyter, Peter De JaegereAbstract:Objectives: Using multislice computed tomography (MSCT), we sought to evaluate the geometry and apposition of the CoreValve ReValving System (CRS, Medtronic, Luxembourgh, Luxembourgh) in patients w...
Tommy Andersson - One of the best experts on this subject based on the ideXlab platform.
-
e 101 economic impact of the first pass effect fpe in the treatment of stroke with the embotrap ii device in arise ii
Journal of NeuroInterventional Surgery, 2019Co-Authors: Osama O Zaidat, Albert J Yoo, J L Saver, Heinrich Mattle, Hormozd Bozorgchami, Ana Paula Narata, M Ribo, Concetta Crivera, Heather L Cameron, Tommy AnderssonAbstract:Introduction The first pass effect (FPE), a measure of thrombectomy device’s ability to restore near or complete revascularization (modified Thrombolysis in Cerebral Ischemia [mTICI] ≥2c) in a single pass, may be considered as a benchmark for thrombectomy devices in the treatment of acute ischemic stroke. While the FPE has been shown to be an independent predictor of good functional outcomes (modified Rankin Scale [mRS] ≤2) and is associated with reduced 90-day mortality, the economic impact of achieving the FPE has not been assessed. Methodology Data were obtained from the EMBOTRAP II device, ARISE-II (n=227) study. FPE was defined as complete revascularization (mTICI ≥2c) after the first pass of the EMBOTRAP II device. Patients who did not achieve complete revascularization within the ARISE-II population were excluded from the analysis. Healthcare resources included total hospital length of stay (LOS), days in the intensive care unit (ICU), standard bed days, and procedural device use (stent retrievers and aspiration devices). Costs from the literature, in 2018 USD, were applied to healthcare resources. Results In ARISE-II, 76% of patients (n=172) achieved complete revascularization; among these patients, 53% achieved the FPE. Among patients that achieved complete revascularization, baseline characteristics were well-balanced between patients that did or did not achieve the FPE. A significantly higher percentage of patients that achieved the FPE had good functional outcomes vs. those that did not achieve the FPE (80.5% vs. 61.0%, p=0.006). Healthcare resource use was lower among patients that achieved the FPE. While patients that achieved the FPE required only a single EMBOTRAP II device, 35% of the patients that did not achieve the FPE required both the EMBOTRAP II device and an additional device to achieve complete revascularization. Patients that achieved the FPE had a significantly shorter LOS (6.1 vs. 9.5 days, p=0.004) and fewer days spent in a standard bed (3.1 vs. 6.1, p=0.004) vs. those that did not achieve the FPE. Overall, the reduction in healthcare resource use associated with achieving the FPE led to estimated per-patient cost-savings of $6,355 (table 1). In the absence of cost data reported in ARISE-II, costs for healthcare resource use were obtained from the literature, which may not be generalizable across settings and is a limitation of this analysis. Additionally, this analysis did not include all components of health resource use that may impact costs (e.g., procedure time, surgical evacuation for symptomatic intracranial hemorrhage [sICH]). Conclusion Among patients with final complete reperfusion (mTICI≥2c), achieving the FPE may lead to per-patient cost-savings of $6,355 due to reductions in procedural and in-patient healthcare resource use. Disclosure O. Zaidat: 1; C; Cerenovus, Stryker, Medtronic, Penumbra, Genentech. 2; C; Stryker, Cerenovus, Penumbra, Medtronic. J. Saver: 2; C; Cerenovus, Stryker, Medtronic, Rapid Medical. 4; C; Rapid Medical. 5; C; University of California. H. Mattle: 1; C; Neuravi/Cerenovus. 2; C; Neuravi/Cerenovus. 3; C; Neuravi/Cerenovus. H. Bozorgchami: 2; C; Cerenovus, Stryker, Coherex. A. Narata: None. A. Yoo: 1; C; Cerenovus, Stryker, Medtronic, Penumbra, Genentech. 2; C; Cerenovus, Genentech, Zoll Circulation. 4; C; Insera Therapeutics. M. Ribo: 1; C; Stryker, Medtronic. 2; C; Cerenovus, Stryker, Medtronic, Anaconda Biomed. 4; C; Anaconda Biomed. C. Crivera: 4; C; Johnson & Johnson. 5; C; Johnson & Johnson. H. Cameron: 5; C; Cornerstone Research Group, contracted by Cerenovus. T. Andersson: 2; C; Cerenovus, Anaconda, Medtronic, Rapid Medical, Ablynx, Amnis Therapeutics.
-
p 015 long term economic impact of the first pass effect fpe in the treatment of stroke with the embotrap ii device in arise ii
Journal of NeuroInterventional Surgery, 2019Co-Authors: Osama O Zaidat, Albert J Yoo, J L Saver, Heinrich Mattle, Hormozd Bozorgchami, Ana Paula Narata, M Ribo, Concetta Crivera, Heather L Cameron, Tommy AnderssonAbstract:Introduction The first pass effect (FPE) is the ability to restore near or complete revascularization (modified Thrombolysis in Cerebral Ischemia [mTICI] ≥2c) of acutely blocked cerebral arteries in a single thrombectomy device pass. FPE has been shown to be an independent predictor of good functional outcomes (modified Rankin Scale [mRS] ≤2), a goal of stroke therapy that impacts healthcare costs, and is associated with reduced 90-day mortality and fewer adverse events. A separate analysis of ARISE-II data showed that the FPE was associated with reduced procedural and in-patient healthcare resource use (length of stay, days in the intensive care unit, standard bed days, and devices used) and accompanying short-term costs; however, the long-term economic impact of achieving the FPE has not been assessed. Methodology Data were obtained from a single-arm, prospective, multicenter study assessing the EMBOTRAP II device, ARISE-II (n=227). Patients who did not achieve complete revascularization were excluded. Among those who achieved complete revascularization (mTICI≥2c), the proportion of patients achieving each mRS score was assessed, stratified by the FPE status. Long-term costs per mRS score, obtained from a 2015 U.S. cost-effectiveness analysis that projected annual post-hospitalization inpatient/outpatient and nursing home costs using data from the National Death Index and Centers for Medicare and Medicaid Services (CMS), were applied to all patients. Post-hospitalization costs, in 2018 USD, were then compared between patients that did or did not achieve the FPE and incremental differences were calculated for a 1-year time horizon. Results In ARISE-II, 76% of patients (n=172) achieved complete revascularization; among these patients, 53% achieved the FPE. A significantly higher percentage of patients that achieved the FPE had good functional outcomes vs. those that did not achieve the FPE (80.5% vs. 61.0%, p=0.006). Estimated annual post-hospitalization costs were lower among patients that achieved FPE vs. those that did not achieve FPE, leading to estimated per-patient cost-savings of $3,876 (table 1). In the absence of cost data reported in ARISE-II, costs for healthcare resource use were obtained from the literature, which may not be generalizable across settings and is a limitation of this analysis. Additionally, the cost-effectiveness analysis used to inform the long-term costs per mRS score did not report costs for death (i.e., mRS 6), which had a lower incidence among patients who achieved the FPE vs. those who did not achieve the FPE (5.75% vs. 14.29%). Conclusion Among patients with final complete reperfusion (mTICI≥2c), achieving FPE may lead to long-term per-patient cost-savings of $3,876 in the first year due to improved functional outcomes. Disclosures O. Zaidat: 1; C; Cerenovus, Stryker, Medtronic, Penumbra, Genentech, Tesla Clinical Trial. 2; C; Cerenovus, Stryker, Medtronic, Penumbra. J. Saver: 2; C; Cerenovus, Stryker, Medtronic, Rapid Medical. H. Mattle: 1; C; Neuravi/Cerenovus. 2; C; Neuravi/Cerenovus. 3; C; Neuravi/Cerenovus. M. Ribo: 1; C; Stryker, Medtronic. 2; C; Cerenovus, Stryker, Medtronic, Anaconda Biomed. 4; C; Anaconda Biomed. A. Narata: None. A. Yoo: 1; C; Cerenovus, Stryker, Medtronic, Penumbra, Genentech. 2; C; Cerenovus, Genentech, Zoll Circulation. 4; C; Insera Therapeutics. H. Bozorgchami: 2; C; Cerenovus, Stryker, Coherex. C. Crivera: 4; C; Johnson & Johnson. 5; C; Johnson & Johnson. H. Cameron: 2; C; Employee of Cornerstone Research Group, contracted by Cerenovus. T. Andersson: 2; C; Cerenovus, Anaconda, Medtronic, Ablynx, Amnis Therapeutics, Rapid Medical.
Osama O Zaidat - One of the best experts on this subject based on the ideXlab platform.
-
e 101 economic impact of the first pass effect fpe in the treatment of stroke with the embotrap ii device in arise ii
Journal of NeuroInterventional Surgery, 2019Co-Authors: Osama O Zaidat, Albert J Yoo, J L Saver, Heinrich Mattle, Hormozd Bozorgchami, Ana Paula Narata, M Ribo, Concetta Crivera, Heather L Cameron, Tommy AnderssonAbstract:Introduction The first pass effect (FPE), a measure of thrombectomy device’s ability to restore near or complete revascularization (modified Thrombolysis in Cerebral Ischemia [mTICI] ≥2c) in a single pass, may be considered as a benchmark for thrombectomy devices in the treatment of acute ischemic stroke. While the FPE has been shown to be an independent predictor of good functional outcomes (modified Rankin Scale [mRS] ≤2) and is associated with reduced 90-day mortality, the economic impact of achieving the FPE has not been assessed. Methodology Data were obtained from the EMBOTRAP II device, ARISE-II (n=227) study. FPE was defined as complete revascularization (mTICI ≥2c) after the first pass of the EMBOTRAP II device. Patients who did not achieve complete revascularization within the ARISE-II population were excluded from the analysis. Healthcare resources included total hospital length of stay (LOS), days in the intensive care unit (ICU), standard bed days, and procedural device use (stent retrievers and aspiration devices). Costs from the literature, in 2018 USD, were applied to healthcare resources. Results In ARISE-II, 76% of patients (n=172) achieved complete revascularization; among these patients, 53% achieved the FPE. Among patients that achieved complete revascularization, baseline characteristics were well-balanced between patients that did or did not achieve the FPE. A significantly higher percentage of patients that achieved the FPE had good functional outcomes vs. those that did not achieve the FPE (80.5% vs. 61.0%, p=0.006). Healthcare resource use was lower among patients that achieved the FPE. While patients that achieved the FPE required only a single EMBOTRAP II device, 35% of the patients that did not achieve the FPE required both the EMBOTRAP II device and an additional device to achieve complete revascularization. Patients that achieved the FPE had a significantly shorter LOS (6.1 vs. 9.5 days, p=0.004) and fewer days spent in a standard bed (3.1 vs. 6.1, p=0.004) vs. those that did not achieve the FPE. Overall, the reduction in healthcare resource use associated with achieving the FPE led to estimated per-patient cost-savings of $6,355 (table 1). In the absence of cost data reported in ARISE-II, costs for healthcare resource use were obtained from the literature, which may not be generalizable across settings and is a limitation of this analysis. Additionally, this analysis did not include all components of health resource use that may impact costs (e.g., procedure time, surgical evacuation for symptomatic intracranial hemorrhage [sICH]). Conclusion Among patients with final complete reperfusion (mTICI≥2c), achieving the FPE may lead to per-patient cost-savings of $6,355 due to reductions in procedural and in-patient healthcare resource use. Disclosure O. Zaidat: 1; C; Cerenovus, Stryker, Medtronic, Penumbra, Genentech. 2; C; Stryker, Cerenovus, Penumbra, Medtronic. J. Saver: 2; C; Cerenovus, Stryker, Medtronic, Rapid Medical. 4; C; Rapid Medical. 5; C; University of California. H. Mattle: 1; C; Neuravi/Cerenovus. 2; C; Neuravi/Cerenovus. 3; C; Neuravi/Cerenovus. H. Bozorgchami: 2; C; Cerenovus, Stryker, Coherex. A. Narata: None. A. Yoo: 1; C; Cerenovus, Stryker, Medtronic, Penumbra, Genentech. 2; C; Cerenovus, Genentech, Zoll Circulation. 4; C; Insera Therapeutics. M. Ribo: 1; C; Stryker, Medtronic. 2; C; Cerenovus, Stryker, Medtronic, Anaconda Biomed. 4; C; Anaconda Biomed. C. Crivera: 4; C; Johnson & Johnson. 5; C; Johnson & Johnson. H. Cameron: 5; C; Cornerstone Research Group, contracted by Cerenovus. T. Andersson: 2; C; Cerenovus, Anaconda, Medtronic, Rapid Medical, Ablynx, Amnis Therapeutics.
-
p 015 long term economic impact of the first pass effect fpe in the treatment of stroke with the embotrap ii device in arise ii
Journal of NeuroInterventional Surgery, 2019Co-Authors: Osama O Zaidat, Albert J Yoo, J L Saver, Heinrich Mattle, Hormozd Bozorgchami, Ana Paula Narata, M Ribo, Concetta Crivera, Heather L Cameron, Tommy AnderssonAbstract:Introduction The first pass effect (FPE) is the ability to restore near or complete revascularization (modified Thrombolysis in Cerebral Ischemia [mTICI] ≥2c) of acutely blocked cerebral arteries in a single thrombectomy device pass. FPE has been shown to be an independent predictor of good functional outcomes (modified Rankin Scale [mRS] ≤2), a goal of stroke therapy that impacts healthcare costs, and is associated with reduced 90-day mortality and fewer adverse events. A separate analysis of ARISE-II data showed that the FPE was associated with reduced procedural and in-patient healthcare resource use (length of stay, days in the intensive care unit, standard bed days, and devices used) and accompanying short-term costs; however, the long-term economic impact of achieving the FPE has not been assessed. Methodology Data were obtained from a single-arm, prospective, multicenter study assessing the EMBOTRAP II device, ARISE-II (n=227). Patients who did not achieve complete revascularization were excluded. Among those who achieved complete revascularization (mTICI≥2c), the proportion of patients achieving each mRS score was assessed, stratified by the FPE status. Long-term costs per mRS score, obtained from a 2015 U.S. cost-effectiveness analysis that projected annual post-hospitalization inpatient/outpatient and nursing home costs using data from the National Death Index and Centers for Medicare and Medicaid Services (CMS), were applied to all patients. Post-hospitalization costs, in 2018 USD, were then compared between patients that did or did not achieve the FPE and incremental differences were calculated for a 1-year time horizon. Results In ARISE-II, 76% of patients (n=172) achieved complete revascularization; among these patients, 53% achieved the FPE. A significantly higher percentage of patients that achieved the FPE had good functional outcomes vs. those that did not achieve the FPE (80.5% vs. 61.0%, p=0.006). Estimated annual post-hospitalization costs were lower among patients that achieved FPE vs. those that did not achieve FPE, leading to estimated per-patient cost-savings of $3,876 (table 1). In the absence of cost data reported in ARISE-II, costs for healthcare resource use were obtained from the literature, which may not be generalizable across settings and is a limitation of this analysis. Additionally, the cost-effectiveness analysis used to inform the long-term costs per mRS score did not report costs for death (i.e., mRS 6), which had a lower incidence among patients who achieved the FPE vs. those who did not achieve the FPE (5.75% vs. 14.29%). Conclusion Among patients with final complete reperfusion (mTICI≥2c), achieving FPE may lead to long-term per-patient cost-savings of $3,876 in the first year due to improved functional outcomes. Disclosures O. Zaidat: 1; C; Cerenovus, Stryker, Medtronic, Penumbra, Genentech, Tesla Clinical Trial. 2; C; Cerenovus, Stryker, Medtronic, Penumbra. J. Saver: 2; C; Cerenovus, Stryker, Medtronic, Rapid Medical. H. Mattle: 1; C; Neuravi/Cerenovus. 2; C; Neuravi/Cerenovus. 3; C; Neuravi/Cerenovus. M. Ribo: 1; C; Stryker, Medtronic. 2; C; Cerenovus, Stryker, Medtronic, Anaconda Biomed. 4; C; Anaconda Biomed. A. Narata: None. A. Yoo: 1; C; Cerenovus, Stryker, Medtronic, Penumbra, Genentech. 2; C; Cerenovus, Genentech, Zoll Circulation. 4; C; Insera Therapeutics. H. Bozorgchami: 2; C; Cerenovus, Stryker, Coherex. C. Crivera: 4; C; Johnson & Johnson. 5; C; Johnson & Johnson. H. Cameron: 2; C; Employee of Cornerstone Research Group, contracted by Cerenovus. T. Andersson: 2; C; Cerenovus, Anaconda, Medtronic, Ablynx, Amnis Therapeutics, Rapid Medical.
Friedrich W Mohr - One of the best experts on this subject based on the ideXlab platform.
-
structural valve deterioration of a corevalve prosthesis 9 months after implantation
European Heart Journal, 2013Co-Authors: Joerg Seeburger, Michael A Borger, Gabriel Weiss, Friedrich W MohrAbstract:An 82-year-old male patient underwent transfemoral aortic valve replacement (Medtronic CoreValve, 26 mm) as a valve-in-valve procedure 9 months ago. Previous history included aortic valve implantation for severe aortic …
-
predictors of permanent pacemaker implantation after Medtronic corevalve bioprosthesis implantation
Europace, 2012Co-Authors: Thomas Schroeter, Axel Linke, Martin Haensig, Denis R Merk, Michael A Borger, Friedrich W Mohr, Gerhard SchulerAbstract:Aims High-grade conduction disturbances requiring permanent pacemaker (PPM) implantation occur in up to 40% of patients following transcatheter aortic valve implantation (TAVI). The aim of this study was to identify pre-operative risk factors for PPM implantation after TAVI with the Medtronic CoreValve prosthesis (CVP). Methods and results We retrospectively analysed 109 patients following transfemoral CVP implantation performed between 2008 and 2009 at the Leipzig Heart Center. Patients who had indwelling PPM at the time of TAVI ( n = 21) were excluded, leaving 88 patients for analysis. Mean age was 80.3 ± 6.6 years and logistic EuroScore predicted risk of mortality was 23.3 ± 12.1%. A total of 32 patients (36%) underwent PPM implantation post-TAVI during the same hospital admission. A total of 27/88 (31%) had evidence of pre-operative abnormal conduction, including first degree AV block and left bundle brunch block. Statistically significant risk factors for the need for post-operative PPM were patient age >75 years [ P = 0.02, odds ratio (OR) 4.6], pre-operative heart rate 4 mm ( P = 0.03, OR 2.8), CVP prosthesis >26 mm (OR 2.2), atrial fibrillation ( P = 0.001, OR 5.2), and ventricular rate <65 b.p.m. at the first post-operative day ( P = 0.137, OR 6.0). Conclusion PPM implantation occurs frequently after transfemoral TAVI with the CVP. Older age, chronic atrial fibrillation, pre-operative bradycardia, and larger or significantly oversized prostheses were independent risk factors for PPM implantation following TAVI with the CVP.