Modifiable risk factors for permanent pacemaker after transcatheter aortic valve implantation: CONDUCT registry

Objective The onset of new conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) is still a relevant adverse event. The main objective of this registry was to identify modifiable procedural risk factors for an improved outcome (lower rate of PPI) after TAVI in patients at high risk of PPI. Methods Patients from four European centres receiving a balloon-expandable TAVI (Edwards SAPIEN 3/3 Ultra) and considered at high risk of PPI (pre-existing conduction disturbance, heavily calcified left ventricular outflow tract or short membranous septum) were prospectively enrolled into registry. Results A total of 300 patients were included: 42 (14.0%) required PPI after TAVI and 258 (86.0%) did not. Patients with PPI had a longer intensive care unit plus intermediate care stay (65.7 vs 16.3 hours, p<0.001), general ward care stay (6.9 vs 5.3 days, p=0.004) and later discharge (8.6 vs 5.0 days, p<0.001). Of the baseline variables, only pre-existing right bundle branch block at baseline (OR 6.8, 95% CI 2.5 to 18.1) was significantly associated with PPI in the multivariable analysis. Among procedure-related variables, oversizing had the highest impact on the rate of PPI: higher than manufacturer-recommended sizing, mean area oversizing as well as the use of the 29 mm valve (OR 3.4, 95% CI 1.4 to 8.5, p=0.008) all were significantly associated with PPI. Rates were higher with the SAPIEN 3 (16.1%) vs SAPIEN 3 Ultra (8.5%), although not statistically significant but potentially associated with valve sizing. Implantation depth and postdelivery balloon dilatation also tended to affect PPI rates but without a statistical significance. Conclusion Valve oversizing is a strong procedure-related risk factor for PPI following TAVI. The clinical impact of the valve type (SAPIEN 3), implantation depth, and postdelivery balloon dilatation did not reach significance and may reflect already refined procedures in the participating centres, giving attention to these avoidable risk factors. Trial registration number NCT03497611.

[1]  B. Prendergast,et al.  2021 ESC/EACTS Guidelines for the management of valvular heart disease. , 2021, European heart journal.

[2]  D. Fischman,et al.  Predictors of Permanent Pacemaker Implantation in Patients Undergoing Transcatheter Aortic Valve Replacement ‐ A Systematic Review and Meta‐Analysis , 2021, Journal of the American Heart Association.

[3]  W. Aronow,et al.  Predictors of permanent pacemaker insertion after TAVR: A systematic review and updated meta‐analysis , 2021, Journal of cardiovascular electrophysiology.

[4]  R. Fan,et al.  Effects of COPD on in‐hospital outcomes of transcatheter aortic valve implantation: Results from the National Inpatient Sample database , 2020, Clinical cardiology.

[5]  R. Arora,et al.  Two-year outcomes from the PARTNER 3 trial: where do we stand? , 2020, Current opinion in cardiology.

[6]  W. Rottbauer,et al.  Risk factors for permanent pacemaker implantation in patients receiving a balloon-expandable transcatheter aortic valve prosthesis , 2020, Heart and Vessels.

[7]  L. Fauchier,et al.  Pacemaker Implantation After Balloon‐ or Self‐Expandable Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis , 2020, Journal of the American Heart Association : Cardiovascular and Cerebrovascular Disease.

[8]  E. Agricola,et al.  Impact of Left Ventricular Outflow Tract Calcification on Pacemaker Implantation After Transcatheter Aortic Valve Implantation With Second-Generation Devices. , 2020, The Journal of invasive cardiology.

[9]  Adnan Kastrati,et al.  Evaluación multicéntrica del sobredimensionamiento de la prótesis transcatéter SAPIEN 3. Impacto en el fallo del dispositivo y nuevos implantes de marcapasos , 2019, Revista Española de Cardiología.

[10]  C. Hengstenberg,et al.  Multicenter Evaluation of Prosthesis Oversizing of the SAPIEN 3 Transcatheter Heart Valve. Impact on Device Failure and New Pacemaker Implantations. , 2019, Revista espanola de cardiologia.

[11]  W. Rottbauer,et al.  New generation devices for transfemoral transcatheter aortic valve replacement are superior compared with last generation devices with respect to VARC-2 outcome , 2018, Cardiovascular Intervention and Therapeutics.

[12]  Jeroen J. Bax,et al.  Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review , 2018, European heart journal.

[13]  T. Folliguet,et al.  Incidence, indications and predicting factors of permanent pacemaker implantation after transcatheter aortic valve implantation: A retrospective study. , 2017, Archives of cardiovascular diseases.

[14]  D. Berman,et al.  A Highly Predictive Risk Model for Pacemaker Implantation After TAVR. , 2017, JACC. Cardiovascular imaging.

[15]  W. Rottbauer,et al.  Predictors for permanent pacemaker implantation in patients undergoing transfemoral aortic valve implantation with the Edwards Sapien 3 valve , 2017, Clinical Research in Cardiology.

[16]  C. Macaya,et al.  Transcatheter versus surgical aortic valve replacement in moderate and high-risk patients: a meta-analysis , 2016, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[17]  S. Rosenkranz,et al.  Predictors of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement With the SAPIEN 3. , 2016, JACC. Cardiovascular interventions.

[18]  M. Laule,et al.  Optimized Implantation Height of the Edwards SAPIEN 3 Valve to Minimize Pacemaker Implantation After TAVI. , 2016, Journal of interventional cardiology.

[19]  H. Baumgartner,et al.  Changes in the Pacemaker Rate After Transition From Edwards SAPIEN XT to SAPIEN 3 Transcatheter Aortic Valve Implantation: The Critical Role of Valve Implantation Height. , 2016, JACC. Cardiovascular interventions.

[20]  M. Mack,et al.  Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. , 2016, The New England journal of medicine.

[21]  Mao Chen,et al.  VALVULAR AND STRUCTURAL HEART DISEASES Original Studies The Relationship Between Chronic Obstructive Pulmonary Disease and Transcatheter Aortic Valve Implantation — A Systematic Review and Meta-Analysis , 2016 .

[22]  C. Hengstenberg,et al.  Predictors of Permanent Pacemaker Implantations and New-Onset Conduction Abnormalities With the SAPIEN 3 Balloon-Expandable Transcatheter Heart Valve. , 2016, JACC. Cardiovascular interventions.

[23]  U. Steinseifer,et al.  Calcium distribution patterns of the aortic valve as a risk factor for the need of permanent pacemaker implantation after transcatheter aortic valve implantation. , 2016, European heart journal cardiovascular Imaging.

[24]  G. Gerosa,et al.  Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve. , 2015, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[25]  Peter Jüni,et al.  Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis. , 2014, Journal of the American College of Cardiology.

[26]  T. Helmberger,et al.  MSCT guided sizing of the Edwards Sapien XT TAVI device: impact of different degrees of oversizing on clinical outcome. , 2013, International journal of cardiology.

[27]  P. Leprince,et al.  Prognostic Implications of Pulmonary Hypertension in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation: Study From the FRANCE 2 Registry , 2013, Circulation. Cardiovascular interventions.

[28]  Jennifer Taylor,et al.  ESC/EACTS Guidelines on the management of valvular heart disease. , 2012, European heart journal.

[29]  D. Wood,et al.  Edwards SAPIEN 3 valve. , 2012, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[30]  Stuart J Pocock,et al.  Transcatheter versus surgical aortic-valve replacement in high-risk patients. , 2011, The New England journal of medicine.

[31]  M. Mack,et al.  Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry. , 2015, JACC. Cardiovascular interventions.