Author + information
- Received August 15, 2017
- Revision received October 2, 2017
- Accepted October 10, 2017
- Published online January 15, 2018.
- Lennart van Gils, MDa,
- Jochen Wöhrle, MDb,
- David Hildick-Smith, MDc,
- Sabine Bleiziffer, MDd,
- Daniel J. Blackman, MDe,
- Mohamed Abdel-Wahab, MDf,
- Ulrich Gerckens, MDg,
- Stephen Brecker, MDh,
- Vinayak Bapat, MDi,
- Thomas Modine, MD, PhDj,
- Osama I. Soliman, MD, PhDk,
- Andrey Nersesov, BSl,
- Dominic Allocco, MDl,
- Volkmar Falk, MD, PhDm,n and
- Nicolas M. Van Mieghem, MD, PhDa,∗ ()
- aDepartment of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
- bDepartment of Internal Medicine II, University of Ulm, Ulm, Germany
- cDepartment of Cardiology, Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, United Kingdom
- dDepartment of Cardiovascular Surgery, Clinic for Cardiovascular Surgery, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany
- eDepartment of Cardiology, Leeds General Infirmary, Leeds, United Kingdom
- fDepartment of Cardiology, Herzzentrum, Segeberger Kliniken, Bad Segeberg, Germany
- gDepartment of Cardiology, University of Rostock, Rostock, Germany
- hDepartment of Cardiology, St. George's Hospital, London, United Kingdom
- iDepartment of Cardiac Surgery, Guy's and St Thomas' Hospital, London, United Kingdom
- jDepartment of Cardiovascular Surgery, CHRU Lille - Hôpital Cardiologique, Lille, France
- kCardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands
- lBoston Scientific Corporation, Marlborough, Massachusetts
- mDepartment of Cardiothoracic and Vascular Surgery, Klinik für Herz-Thorax-Gefässchirurgie, Deutsches Herzzentrum Berlin, Berlin, Germany
- nDepartment of Cardiovascular Surgery, Klinik für Kardiovaskulr Chirurgie, Charite Berlin, Berlin, Germany
- ↵∗Address for correspondence:
Dr. Nicolas M. Van Mieghem, Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Room Bd 171, ‘s Gravendijkwal 230 3015 CE Rotterdam, the Netherlands.
Objectives The aim of this post hoc analysis from the RESPOND (Repositionable Lotus Valve System–Post-Market Evaluation of Real World Clinical Outcomes) post-market study was to assess the final implantation depth on the contrast aortogram after Lotus valve (Boston Scientific, Marlborough, Massachusetts) transcatheter aortic valve replacement (TAVR) and to correlate with permanent pacemaker implantation (PPI) and paravalvular leak (PVL).
Background Contrast aortography allows for the assessment of implantation depth and PVL during and after TAVR. Previous reports suggested an association between final device position and rates of PPI and PVL.
Methods The RESPOND study was a prospective, open-label, single-arm study in 41 centers evaluating outcomes after Lotus TAVR in routine clinical practice. Aortograms were collected at the Erasmus Medical Center and analyzed by researchers who were blinded to clinical outcomes. The primary analysis correlated implantation depth with PPI and PVL and required aortograms in a coaxial projection. The relation between implantation depth and need for PPI was assessed by multivariate logistic regression, adjusting for pre-defined confounders. A secondary analysis compared PVL analysis by contrast aortography with transthoracic echocardiography (TTE) performed by the independent core laboratory.
Results A total of 724 angiographic studies were included in this analysis. Mean Lotus implantation depth was 6.67 ± 2.19 mm. The overall PPI rate was 35%. PPI rate was lower with shallow implants (<6.5 mm: 21% vs. ≥6.5 mm: 41%; p < 0.001). After adjustment for confounders, implantation depth independently predicted need for PPI (odds ratio per 1-mm increment in depth: 1.200; 95% confidence interval: 1.091 to 1.319; p = 0.002). More than trivial PVL was present in 23% by contrast aortography and in 8% by TTE. Implantation depth was not correlated with PVL by contrast aortography or TTE (p = 0.342 and p = 0.149, respectively). PVL grading by contrast aortography and TTE was concordant in 77%.
Conclusions In this post hoc analysis of the RESPOND study PPI was highly correlated with implantation depth, whereas PVL was not. Higher Lotus implantation may reduce need for PPI.
Dr. Wöhrle has received research grant support from Boston Scientific. Dr. Hildick-Smith has served as a proctor and consultant for Boston Scientific, Medtronic, and Edwards Lifesciences. Dr. Bleiziffer has served as a proctor and consultant for Medtronic. Dr. Abdel-Wahab has served as a proctor for Boston Scientific. Dr. Gerckens has served as a consultant and proctor for Medtronic and Boston Scientific. Dr. Brecker has served as a consultant for Medtronic and Boston Scientific. Dr. Bapat has served as a consultant for Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and 4tech. Dr. Modine has a served as a consultant for Boston Scientific. Mr. Nersesov and Dr. Allocco are full-time employees of Boston Scientific. Dr. Van Mieghem has received research grant support from Claret Medical, Abbott Vascular, Boston Scientific, Medtronic, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 15, 2017.
- Revision received October 2, 2017.
- Accepted October 10, 2017.