Author + information
- Received March 21, 2017
- Revision received April 27, 2017
- Accepted May 4, 2017
- Published online August 7, 2017.
- Helge Möllmann, MDa,∗ (, )
- Axel Linke, MDb,
- David M. Holzhey, MDb,
- Thomas Walther, MDc,
- Ganesh Manoharan, MDd,
- Ulrich Schäfer, MDe,
- Karl Heinz-Kuck, MDf,
- Ad J. Van Boven, MD, PhDg,
- Simon R. Redwood, MDh,
- Jan Kovac, MDi,
- Christian Butter, MDj,
- Lars Søndergaard, MDk,
- Alexander Lauten, MDl,
- Gerhard Schymik, MDm and
- Stephen G. Worthley, MDn
- aSt. Johannes Hospital, Dortmund, Germany
- bHerzzentrum Leipzig, Leipzig, Germany
- cKerckhoff Klinik, Bad Nauheim, Germany
- dRoyal Victoria Hospital, Belfast, United Kingdom
- eUniversity Heart Center Hamburg, Hamburg, Germany
- fAsklepios Kliniken, Hamburg, Germany
- gMC Leeuwarden, Leeuwarden, the Netherlands
- hSt. Thomas’ Hospital, London, United Kingdom
- iGlenfield Hospital, Leicester, United Kingdom
- jHeart Center of Bernau, Bernau, Germany
- kRighospitalet University of Copenhagen, Copenhagen, Denmark
- lDepartment of Cardiology, Charité – Universitaetsmedizin Berlin, Berlin, Germany
- mMedical Clinic IV, Department of Cardiology, Municipal Hospital Karlsruhe, Karlsruhe, Germany
- nGenesisCare, Adelaide, Australia
- ↵∗Address for correspondence:
Prof. Helge Möllmann, St. Johannes Hospital, Klinik für Medizin I, Johannesstraße 9-13, 44137 Dortmund, Germany.
Objectives The aim of this study was to evaluate the short-term safety and performance of the full range of valve sizes offered within the Portico transcatheter aortic valve replacement system.
Background The Portico transcatheter aortic heart valve is a fully resheathable, repositionable, and self-expanding bioprosthesis designed to achieve optimal valve position and hemodynamic performance and limit conduction disturbances.
Methods Patients (n = 222) with symptomatic (New York Heart Association functional class ≥II) severe aortic stenosis considered by a multidisciplinary heart team to be at high surgical risk were recruited between December 2011 and September 2015 in this prospective, nonrandomized, multicenter study. Patients were implanted with the full range of Portico heart valves (23, 25, 27, and 29 mm) using the transfemoral approach. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included valve performance, improvement in functional class, and procedural outcomes as defined by Valve Academic Research Consortium criteria.
Results A total of 220 patients (mean age 83.0 ± 4.6 years, 74.3% women, mean Society of Thoracic Surgeons score 5.8%) had valves implanted. All resheathing and repositioning attempts (n = 72) were successful. At 30 days, all-cause mortality was 3.6%. Procedural outcomes included disabling (major) stroke (3.2%), major vascular complications (7.2%), and permanent pacemaker implantation (13.5%). Compared with baseline, 75.8% of patients improved by ≥1 New York Heart Association functional class at 30 days. The rate of moderate paravalvular leak was 5.7%, with no severe paravalvular leak reported. No differences in paravalvular leak incidence and severity were observed among valve sizes (p = 0.24).
Conclusions Across all valve sizes, use of the repositionable Portico transcatheter aortic valve replacement system resulted in safe and effective treatment of aortic stenosis in high-risk patients.
Patients with severe symptomatic aortic stenosis (AS) considered to be at high risk for surgical aortic valve replacement are shown to benefit from transcatheter aortic valve replacement (TAVR) (1,2). Data from large randomized controlled trials show that survival rates of patients with severe AS who undergo TAVR are superior to those in patients treated with conventional medical therapy (3) and comparable with those in patients who undergo surgical valve replacement (4,5). High device success rates and low 30-day mortality have also been reported following TAVR, even in high-risk populations (6–8).
As TAVR becomes a new standard of care for inoperable and high-risk patients, it is recognized that the implantation of first-generation prosthetic aortic valves may be complicated by paravalvular leak (PVL), vascular complications, stroke, and conduction system disturbances requiring permanent pacemaker implantation (PPI). First-generation devices also lack the ability to be repositioned in the case of suboptimal valve position.
The Portico TAVR system (St. Jude Medical, St. Paul, Minnesota) is designed to mitigate some of the complications associated with first-generation valves. Detailed design characteristics of the Portico TAVR system have been described previously (9). Briefly, the system is composed of a bioprosthetic aortic valve with leaflets that function at the annular level immediately upon deployment and is fully resheathable if not released. This feature allows evaluation of the acute valve position and, if required, resheathing and repositioning of the valve to achieve an optimal annular position for adequate acute hemodynamic performance. The implant is an intra-annular, trileaflet bovine pericardial valve, mounted within a self-expanding, nonflared, nitinol frame (Figure 1). Large stent cells minimize the amount of stent metal while maximizing the porcine pericardial tissue cuff, which is mounted within the frame’s annular level to provide enhanced PVL sealing performance (Figure 1).
The device is available in 4 sizes: 23 mm (19- to 21-mm annular diameter), 25 mm (21- to 23-mm annular diameter), 27 mm (23- to 25-mm annular diameter), and 29 mm (25- to 27-mm annular diameter). Transfemoral implantation is performed using the Portico transfemoral delivery system, which has an outer capsule diameter of 18-F (23- and 25-mm valves) or 19-F (27- and 29-mm valves) and a very low insertion profile of 13.5-F (23- and 25-mm valves) and 15-F (27- and 29-mm valves) when used in combination with the SoloPath expandable sheath.
Initial results with the Portico TAVR system in small feasibility studies and using select valve sizes (23- and 25-mm valves only) have been previously described (10–13). The present study provides an overview of the procedural safety, short-term mortality, and valve performance associated with the full range of available sizes (23, 25, 27, and 29 mm) of this new prosthetic aortic valve.
This prospective, nonrandomized, multicenter study (NCT01493284) was conducted across 12 centers in Europe and Australia to assess the safety and performance of the Portico TAVR system for transfemoral implantation at 30 days and 12 months post-implantation. The study was conducted in compliance with the Declaration of Helsinki, and approvals from the appropriate ethics committees and local regulatory authorities were obtained before commencing the study. All patients provided written informed consent before participation in the study. The study was sponsored by Abbott (formerly St. Jude Medical). The initial experience of the participating centers with the Portico TAVR system at 30 days post-implantation, including echocardiographic evaluation and documentation of adverse events, is presented here.
Patients with symptomatic (New York Heart Association [NYHA] functional class ≥II) severe AS at high or prohibitive risk for conventional surgical aortic valve replacement were recruited. A multidisciplinary local heart team assessed patients’ surgical risk using the Society of Thoracic Surgeons Predicted Risk of Operative Mortality (14) and logistic European System for Cardiac Operative Risk Evaluation scores (15,16). Detailed assessments of frailty indexes (including 5-m gait speed test , grip strength testing , and the Katz Index of Independence in Activities of Daily Living ) and surgical comorbidities were also performed. Echocardiographic evidence of AS was confirmed by a mean gradient >40 mm Hg or peak jet velocity >4.0 m/s or an initial valve area <1.0 cm2 or aortic valve area index <0.6 cm2/m2. An independent subject selection committee reviewed each patient to confirm that he or she had acceptable annular measurements for the Portico transcatheter aortic heart valve and met the high surgical risk designation assigned by the local heart team. Key exclusion criteria included a congenitally unicuspid, bicuspid, quadricuspid, or noncalcified native aortic valve observed by echocardiography, mitral or tricuspid valvular regurgitation (grade >II), moderate to severe mitral stenosis, and left ventricular ejection fraction <20%. A comprehensive overview of all inclusion and exclusion criteria is provided in the Online Appendix.
Valve implantation and follow-up
Patients were implanted with the Portico transcatheter aortic heart valve via a transfemoral approach, using the dedicated Portico transfemoral delivery system. Fifty patients were each implanted with the 23-mm and 25-mm valves, whereas 60 patients were each implanted with the 27-mm and 29-mm valves.
Valve implantation was performed under general or local anesthesia. Pre-dilatation by balloon aortic valvuloplasty followed by valve implantation in the absence of rapid pacing was recommended during positioning of the valve in the native aortic annulus. Valve sizing was based on pre-procedural imaging with computed tomography and/or transesophageal echocardiography. Catheter maneuvers were supported by a stiff guidewire positioned in the left ventricle. Valve resheathing and repositioning were performed in patients with suboptimal implantation depth (target depth 1 to 9 mm), valve movement during deployment, or presence of hemodynamically significant PVL. The valve was released after angiographic confirmation of the appropriate implantation position. Post-dilatation was performed at the discretion of the operator to improve sealing and full device expansion at the annulus if aortic insufficiency or valve under-expansion was present on initial deployment. Following successful implantation of the valve, the guidewire was removed and the access site closed percutaneously. Use of antithrombotic therapy after the index procedure was at the discretion of the institutional team and based on the subject’s relative bleeding risk.
All patients were followed up clinically, irrespective of success or failure to implant the device. Transthoracic or transesophageal echocardiographic evaluations were performed at baseline, pre-discharge (24 to 48 h post-implantation), and at 30-day and 3-, 6-, and 12-month follow-up.
Study endpoints and measurements
The primary endpoint of the study was all-cause mortality at 30 days. Secondary clinical endpoints included cardiovascular mortality, myocardial infarction, stroke, acute kidney injury, access-related complications, and bleeding at 30 days. All endpoints were classified according to standardized definitions provided by the Valve Academic Research Consortium (VARC) guidelines (20). Serious adverse events were adjudicated by an independent clinical events committee (Cardiovascular Research Foundation, New York, New York). A composite measure of acute device success was defined according to the full VARC criteria. A comprehensive list of clinical and device-related definitions is provided in the Online Appendix. Improvement in functional status was assessed using the NYHA functional classification system and 6-min walk test. Valve performance was assessed by echocardiographic evaluation. Total aortic regurgitation (AR) and PVL were classified as absent or nonsignificant, mild, moderate, or severe according to the VARC criteria (20). All echocardiographic endpoints were evaluated by an independent echocardiographic core laboratory (Methodist DeBakey Heart and Vascular Center for implantation of 23- and 25-mm valves and Yale University for implantation of 27- and 29-mm valves).
Continuous variables are summarized as mean ± SD. Categorical variables are summarized as frequency (percentage). Paired Student t tests (echocardiographic data, 6-min walk test) and the Wilcoxon signed ranked test (NYHA functional class) were used to compare outcomes at 30 days relative to baseline. Comparison of rates across valve sizes for total number of clinical events committee–adjudicated adverse events and severe or moderate PVL at 30 days and comparison of vascular access event rates between delivery systems were performed using the Fisher exact test. Statistical significance was set at p < 0.05. All statistical analyses were performed using SAS version 9.3 (SAS Institute, Cary, North Carolina).
A total of 222 patients were recruited between December 2011 and September 2015. Patient demographic and baseline data are summarized in Table 1. The study cohort was predominantly female (74.3%), elderly (mean age 83.0 ± 4.6 years), severely symptomatic (78.8% in NYHA functional class III or IV) and considered to be at high surgical risk on the basis of predicted risk of operative mortality (mean Society of Thoracic Surgeons score 5.8 ± 3.3%), indicators of frailty, and/or presence of multiple comorbidities. Patients had a high burden of coronary artery disease (59.0%), atrial fibrillation (38.3%), renal failure or insufficiency (32.9%), diabetes (31.1%), and pulmonary hypertension (30.6%). Approximately one-half of the patients (49.0%) had a 5-m gait speed >6 s, and 67.5% had maximum grip strength below sex- and body mass index–matched thresholds (Table 1).
The majority of patients receiving 23- or 25-mm valves were female (97.1%). A more balanced sex distribution was observed among patients implanted with larger valves (55.0% women). A total of 185 patients attended the 30-day follow-up visit, of whom 177 had analyzable echocardiographic data. Three patients withdrew from the study before the 30-day follow-up visit because of sickness (n = 1) and inability to comply with the study protocol (n = 2). An additional 26 patients were alive at 30 days but were unable to attend the follow-up visit because they were in a rehabilitation facility. No patients were lost to follow-up.
Two hundred twenty patients were implanted with the study device (99.1%). In 2 procedures, the intended implantation of a 25-mm valve was unsuccessful. One patient required the implantation of another commercially available aortic valve (CoreValve, Medtronic, Minneapolis, Minnesota) after becoming severely hypotensive and resistive to drug therapy. In a second patient, the procedure was abandoned because of difficulties advancing the sheath.
Procedural data for implanted patients are summarized in Table 2. Local anesthesia was used in the majority of patients (73.0%). Pre-implantation balloon aortic valvuloplasty was performed in 99.5% of procedures. The resheathing feature was used in 73 of 221 procedures and was successful without complications in all cases. Post-dilatation was performed in approximately one-third of the procedures (32.7%) to ensure full device expansion and annular sealing. The average implantation time (delivery system insertion to removal) was 12.5 ± 10.4 min (Table 2).
Cardiopulmonary bypass was required in 3 patients (1.4%) because of left ventricular perforation caused by the guidewire. Two patients experienced severe bleeding requiring surgical intervention, whereas a third subject went into cardiogenic shock. Chronic steroid use was reported by 1 subject who experienced severe bleeding. In 4 patients (1.8%), valve-in-valve implantation with a second Portico transcatheter aortic heart valve was required because the first valve was implanted too deep or migrated during the procedure.
Table 3 describes acute procedural and device-related outcomes. Overall, a single valve was implanted in the proper anatomic area in 96.8% of patients. Successful vascular access, valve delivery, and deployment and retrieval of the delivery system were reported in 216 of 222 procedures. In those patients with analyzable echocardiographic data (n = 177), acute device success was 84.7%. Procedurally, there were no instances of annular rupture or valve thrombosis (Table 3).
Immediate procedural mortality was 1.4%, with all 3 deaths related to left ventricular perforation induced by the guidewire. New PPI was required in 30 patients (13.5%), of whom 14 received permanent pacemakers on the day of valve implantation for acquired third-degree atrioventricular block (n = 13) and bradyarrhythmia due to chronic atrial fibrillation (n = 1). Only 24 patients (10.8%) in the trial had pre-existing pacemakers before the procedure. No significant difference was found in stent protrusion into the left ventricular outflow tract between patients with and those without permanent pacemakers (6.3 ± 2.1 mm vs. 6.0 ± 2.3 mm; p = 0.58). The need for PPI was similar in patients implanted with the 23-, 27-, and 29-mm valves (16.0%, 16.7%, and 16.7%, respectively), whereas only 3.9% of the patients receiving 25-mm valves required PPI.
Clinical endpoints and adverse events
Clinical events committee–adjudicated adverse events at 30 days are summarized in Table 4. In addition to 3 immediate procedural deaths, 5 patients died during the 30-day follow-up period, resulting in an all-cause mortality rate of 3.6%. All 5 deaths were cardiovascular related and included myocardial infarction (n = 2), cerebral hemorrhage (n = 1), a combination of multiple-organ failure and cardiogenic shock (n = 1), and pneumonia with respiratory failure (n = 1).
Periprocedural myocardial infarction (≤72 h after the index procedure) and acute kidney injury stage III at 30 days post-procedure occurred in 2.3% and 1.4% of patients, respectively. A total of 18 neurological events occurred in 17 patients, with 1 subject experiencing a transient ischemic attack and a disabling (major) stroke. Four transient ischemic attacks and 11 strokes occurred within 10 days of the procedure. The rates of all stroke and disabling (major) stroke at 30 days were 5.4% and 3.2%, respectively. There was no association between resheathing or recapturing the device and incidence of any stroke (p = 1.00) or disabling (major) stroke (p = 0.22) in patients. The total number of VARC-defined adverse events reported at 30 days did not differ significantly among valve sizes (p = 0.53).
Event adjudication identified 8 cases of life-threatening bleeding due to vascular access (n = 3), pericardial effusion, and/or tamponade related to the introduction or removal of a pacing lead (n = 3), guidewire perforation (n = 1), and gastrointestinal bleeding (12 days post-procedure) secondary to antibiotic-associated pseudomembranous colitis (n = 1). One subject with tamponade died despite emergency thoracotomy. The other 7 cases of life-threatening bleeding were resolved without permanent sequelae. There was no difference in vascular access event rates reported between the 2 delivery systems (18 F vs. 19 F; p = 0.53).
As shown in Figure 2, 75.8% of patients improved by at least 1 NYHA functional class, and 23.0% improved by at least 2 NYHA functional classes from baseline to 30 days. Mean 6-min walk distance increased significantly from 206 ± 117 m at baseline to 232 ± 109 m at 30 days (p = 0.001).
Compared with baseline, aortic valve area, effective orifice area index, mean gradient, and peak velocity were all significantly improved at 30 days (p < 0.0001 for all). The mean gradient decreased from 43.3 ± 14.6 to 8.3 ± 3.8 mm Hg, valve area increased from 0.7 ± 0.2 to 1.9 ± 0.5 cm2, effective orifice area index increased from 0.4 ± 0.1 to 1.1 ± 0.3 cm2/m2, and peak velocity was reduced from 411.2 ± 68 to 192.1 ± 42.3 cm/s (Figure 3).
Of the 177 patients with analyzable echocardiographic data at 30 days, 176 had interpretable total AR and PVL data (99.4%). There was no incidence of severe total AR or PVL observed at 30 days, whereas moderate total AR and PVL were 6.2% and 5.7%, respectively. The proportion of patients reporting mild or less PVL at 30 days did not differ across the valve sizes (p = 0.24).
Evaluation of the short-term safety and performance of the full range of Portico transcatheter aortic heart valves resulted in the following key findings: 1) device implantation is safe and is associated with a low 30-day mortality and disabling stroke rate; 2) the resheathable feature is clinically meaningful and allows the operator to optimize the valve position to achieve a high implantation success rate; and 3) there are no marked differences among the various valve sizes related to procedural success, valve performance, or vascular access complications.
In this patient population deemed by a multidisciplinary heart team and independent subject selection committee to be at high surgical risk, procedural safety of the device was indicated by a mortality rate of 3.6% at 30-day follow-up. The observed rate is comparable with first- and second-generation devices (3,4,21,22) and is approaching the low procedural mortality rates reported for third-generation balloon-expandable and self-expandable aortic valves implanted via the transfemoral approach (23,24).
Incidence of known complications following TAVR in the present study is consistent with earlier and newer generation devices. Specifically, the 3.2% rate of disabling (major) stroke at 30 days is within the range of major or disabling stroke rates previously reported for other aortic valves (3,4,21,22,25). Importantly, no association was found between patients who underwent resheathing of the valve and incidence of any stroke (p = 1.00) or disabling (major) stroke (p = 0.22). Among the 12 patients who experienced stroke at 30 days, 4 strokes occurred the day of the index procedure (2 major [disabling] and 2 minor) and 11 within 10 days (91.7%). The early time course of events coupled with a significantly higher implantation duration time suggests that the incidence of stroke in patients was related to aspects of the procedure rather than the valve.
Conduction disorders requiring PPI occurred in 13.5% of the patients, with the most frequent conduction disorder following implantation being third-degree atrioventricular block. Various PPI rates have been reported following TAVR ranging from 3% to 40%, with balloon-expandable valves generally associated with lower PPI rates than self-expandable valves (26). In the present study, only 11% of patients had pre-existing pacemakers at the time of device implantation. Compared with the REPRISE II study (22), patients reported about 50% fewer conduction disturbances requiring PPI (13.5% vs. 28.6%). Importantly, the observed PPI rate in the present study is consistent with the 13.3% and 11.7% rates reported in the recent SAPIEN3 and CoreValve Evolut R CE Pivotal trials, respectively (23,24).
It is possible that the low frequency of PPI following implantation of the Portico transcatheter aortic heart valve is related to the design of the prosthetic frame, specifically its low frame height and nonflared annular skirt with porcine pericardial sealing cuff. Such features are designed to: 1) create an effective annular seal to minimize extension of the valve into the left ventricular outflow tract; and 2) provide a more uniform distribution of radial force to the native annular tissue to reduce trauma to the conduction system. The ability to be repositioned to achieve an optimal annular position is also likely to reduce the need for PPI by avoiding overly deep implantations.
Major vascular complications and life-threatening bleeding at 30 days occurred at acceptably low rates of 7.2% and 3.6%, respectively. The low insertion profile of the nonrigid delivery system with a 13.5-F (for 23 and 25 mm) or 15-F (for 27 and 25 mm) introducer sheath and outer capsule 18- or 19-F sheath is likely to have minimized the risk for major vascular complications in patients. The third-generation Evolut R self-expanding aortic valve, which also uses a low profile delivery system (14- and 16-F introducer sheath) reported a similar major vascular complication rate of 8.3% (24). Three reported cases of major bleeding were shown to be related to vascular access (1.4%), with all cases resolved without further consequences. No annular rupture was observed in this study. Except for 1 case of coronary obstruction, no further interference with other cardiac structures was observed.
A major criticism of earlier TAVR systems is the inability to achieve precise positioning, retrieval, and assessment of valve performance before permanent implantation. In the study, the valve was resheathed in one-third of the procedures, allowing operators to successfully implant a single valve in the proper anatomic location in 96.8% of attempts. Overall, acute device success was 84.7% and is comparable with rates previously reported for second-generation self-expanding aortic valves (using full VARC criteria) in high- and extreme-risk cohorts (7,21).
Hemodynamic status and functional outcomes at 30 days
Significant PVL following valve deployment has been shown to correlate with increased morbidity and mortality (27). At 30 days post-TAVR, only 5.7% of patients showed evidence of moderate PVL, with no cases of severe PVL. This result is comparable with rates reported from other devices (3,5,21). Importantly, no difference in PVL rates at 30 days was observed across any of the 4 valve sizes. Echocardiographic results, evaluated by the core laboratory, showed good hemodynamic performance of the prosthesis, characterized by improved aortic valve area, mean gradient, and peak velocity compared with baseline. This outcome compares favorably with the balloon-expandable aortic devices of the first generation (3) and second generation (28) as well as other commercially available nitinol valves (22).
Compared with their baseline status, three-quarters of patients significantly improved in NYHA functional class at 30 days. The 6-min walk performance also increased by 13% (mean 26-m increase). The small albeit significant change in patients’ 6-min walk performance at 30 days is consistent with other studies that found improvements in 6-min walk performance following TAVR (4) and is likely to represent a clinically relevant improvement in functional status (29).
This was a nonrandomized study and did not allow any direct comparison with other valves. Valve implantation was also limited to the transfemoral approach. For each of the investigators, participation in the study constituted their first clinical experience with the Portico TAVR system. Given that there was no roll-in patient phase, outcomes should be interpreted in view of the operators’ early learning curve, which may underestimate the short-term safety and performance that may be achieved by operators who have gained more experience with the Portico TAVR system.
Across all valve sizes, the Portico TAVR system is safe and achieves appropriate hemodynamic performance at short-term follow-up. The resheathing capabilities offer additional options to the operator to optimize short-term procedural outcomes. Long-term evaluation is required to further characterize the safety and performance of this system, as well as the added value of the resheathing feature.
WHAT IS KNOWN? TAVR is becoming a new standard of care in inoperable and high-risk patients with severe AS. The ability to resheath and reposition an aortic valve prosthesis is recognized as an important design feature to help achieve appropriate valve position and reduce known complications, specifically PVL, during TAVR.
WHAT IS NEW? The new Portico transcatheter aortic heart valve addresses the deficiencies of earlier valves and can be fully resheathed and repositioned in case the initial valve position does not provide satisfactory PVL results. This study highlights the early safety and efficacy of the Portico TAVR system for transfemoral valve implantation with low procedural mortality (3.6%) and appropriate hemodynamic performance (5.7% with moderate to severe PVL) observed at 30-day follow-up. The study also demonstrates that when operators use the resheathing capability to optimize the valve position, they achieve a high implantation success rate.
WHAT IS NEXT? Long-term follow-up is required to fully evaluate the safety and efficacy of this new resheathable self-expanding aortic valve prosthesis. Understanding the clinical relevance of being able to resheath and reposition the device during the deployment process for optimal valve positioning is also needed.
The authors thank Bert Albers from Albers Clinical Evidence Consultancy for drafting the manuscript and Hongfei Guo, PhD, St. Jude Medical, for assisting with the statistical analyses.
For a list of participating investigators and a description of clinical and device endpoints, please see the online version of this article.
This study was sponsored by Abbott (formerly St. Jude Medical), which was responsible for designing the study; collecting, analyzing, and interpreting the data; and collaborating with the investigators regarding the preparation, review, and submission of the manuscript. Prof. Möllmann has received consulting fees and honoraria from Abbott, Biotronik, Edwards Lifesciences, Medtronic, St. Jude Medical, and Symetis. Dr. Manoharan has received consulting fees and honoraria from Medtronic, St. Jude Medical, and Boston Scientific. Dr. Kovac is a proctor for Medtronic and Edwards Lifesciences. Dr. Redwood is a proctor for Edwards Lifesciences; and has received grant support from Edwards Lifesciences and Boston Scientific. Dr. Linke has received speaking honoraria or served as a consultant for Medtronic, St. Jude Medical, Claret Medical, Boston Scientific, Edwards Lifesciences, Symetis, Bard; and owns stock options in Claret Medical. Dr. Holzhey is an advisor for St. Jude Medical and Edwards Lifesciences; and is a proctor for Symetis. Dr. Heinz-Kuck is a consultant for St. Jude Medical and Abbott Vascular; and has received research grants from Biosense Webster, Medtronic, St. Jude Medical, and Boston Scientific. Dr. Schäfer is a clinical proctor for Edwards Lifesciences, Medtronic, Boston Scientific, Symetis, and St. Jude Medical; and has received honoraria from Edwards Lifesciences, Medtronic, Boston Scientific, Symetis, and St. Jude Medical. Dr. Lauten has received proctoring fees from St. Jude Medical; has received speaking honoraria from St. Jude Medical, Edwards Lifesciences, Medtronic, Boehringer, and Berlin-Chemie; and has received consulting fees from Coramaze and TricValve. Dr. Søndergaard is a proctor for and has received institutional research grants from St. Jude Medical, Medtronic, Boston Scientific, Symetis, and Edwards Lifesciences. Dr. Schymik has received proctoring fees and speaking honoraria from St. Jude Medical. Dr. van Boven is a proctor for St. Jude Medical. Dr. Worthley has received advisory fees from Medtronic and St. Jude Medical; and is a proctor for St. Jude Medical.
- Abbreviations and Acronyms
- aortic regurgitation
- aortic stenosis
- New York Heart Association
- permanent pacemaker implantation
- paravalvular leak
- transcatheter aortic valve replacement
- Valve Academic Research Consortium
- Received March 21, 2017.
- Revision received April 27, 2017.
- Accepted May 4, 2017.
- Nishimura R.,
- Otto C.,
- Bonow R.,
- et al.
- Grube E.,
- Schuler G.,
- Buellesfeld L.,
- et al.
- Webb J.,
- Pasupati S.,
- Humphries K.,
- et al.
- Chandrasehkar J.,
- Glover C.,
- Labinaz M.,
- Ruel M.
- Del Trigo M.,
- Dahou A.,
- Webb J.,
- et al.
- Wilson A.,
- Cabau J.,
- Wood D.,
- et al.
- Manoharan G.,
- Linke A.,
- Moellmann H.,
- et al.
- Afilalo J.,
- Eisenberg M.M.J.,
- Morin J.-F.,
- et al.
- Leon M.,
- Piazza N.,
- Nikolsky E.,
- et al.
- Popma J.,
- Adams D.,
- Reardon M.J.,
- et al.
- Meredith I.,
- Walters D.,
- Dumonteil N.,
- et al.
- Webb J.,
- Gerosa G.,
- Lefèvre T.,
- et al.
- Manoharan G.,
- Walton A.,
- Brecker S.,
- et al.
- Schofer J.,
- Colombo A.,
- Klugmann S.,
- et al.
- Généreux P.,
- Head S.,
- Van Mieghem N.,
- et al.
- Webb J.,
- Doshi D.,
- Mack M.,
- et al.
- Gremeaux V.,
- Troisgros O.,
- Benaim S.,
- et al.