Abstract
Objectives
In patients with severe aortic stenosis who are at high risk for surgery, transcatheter aortic valve replacement (TAVR) has emerged as an alternative procedure using EV or CV. The objective of this meta-analysis is to compare 1-year mortality and major adverse cardiovascular and cerebrovascular events (MACCE) between Edwards valve (EV) and Medtronic CoreValve (CV).
Methods
PubMed and the Cochrane Center Register of Controlled Trials were searched through December 2014. Twenty seven studies ( n = 12,249) comparing TAVR procedure that used EV ( n = 5745) and CV ( n = 6504) were included. End points were procedural success rates, post-procedural mortality, myocardial infarction (MI), stroke, major bleeding, major vascular complications, incidence of new permanent pacemaker (PPM) placement and new left bundle branch block (LBBB). The odds ratio (OR) with 95% confidence interval (CI) was computed and p < 0.05 was considered for significance.
Results
There were no significant differences between EV and CV for post-procedural in-hospital, 30-day and 1-year all-cause mortality rates ( p = 0.53, 0.33 and 0.94 respectively), cardiovascular mortality ( p = 0.61), stroke ( p = 0.54), major bleeding ( p = 0.25) and major vascular complications ( p = 0.27). MI was significantly lower with EV compared to CV (OR: 0.56, CI: 0.35–0.89, p = 0.01). Placement of new PPM and new onset LBBB were significantly higher in CV compared to EV (OR: 3.35, CI: 2.96–3.79, p < 0.00001 and OR: 6.55, CI: 4.76–9.03, p < 0.00001 respectively).
Conclusions
The results of our meta-analysis suggest that TAVR procedure using CV may be associated with a higher incidence of MI, new PPM placement, and new onset LBBB compared to EV. However, the type of valve placed does not affect mortality.
Highlights
- •
Mortality following TAVR does not vary between CV and EV at one year.
- •
Incidence of myocardial infarction is higher with CV compared to EV.
- •
Incidence of new permanent pacemaker placement is higher with CV compared to EV.
- •
Incidence of new onset left bundle branch block is higher with CV compared to EV.
1
Introduction
Transcatheter aortic valve replacement (TAVR) is a procedure of choice for patients with severe aortic stenosis (AS) who are not candidates for surgical aortic valve replacement. Studies have shown that TAVR is equivalent to surgical aortic valve replacement in these patients . Two types of devices are widely available for implantation in TAVR procedure. The first one is a balloon-expandable valve; Edwards SAPIEN or Edwards SAPIEN XT valve (EV) (Edwards Lifesciences, Irvine, California); composed initially of stainless steel and now of cobalt chromium frame with bovine pericardial tissues. The other one is a self-expandable valve; Medtronic CoreValve (CV) (Medtronic Inc., Minneapolis, Minnesota); made of porcine pericardial tissue. Both valves may have advantages and disadvantages. The current literature demonstrates that CV is associated with higher rates of atrioventricular blocks requiring permanent pacemaker placement and is associated with higher post-procedural moderate to severe aortic regurgitation rates . EV on the other hand has been associated with annulus rupture and coronary occlusion . Current literature is lacking sufficient randomized controlled data on major adverse cardiovascular and cerebrovascular events (MACCE) directly comparing EV and CV. There are 2 meta-analyses recently published comparing outcomes between EV and CV . The meta-analysis by Biondi-Zoccai et al. was limited to only 4 clinical trials and 3 of them did not have head to head comparison of EV to CV. Another meta-analysis performed by Agarwal et al. was performed on registry data and many of the registries used either EV or CV lacking the head to head comparison between EV to CV. Therefore, these studies may have significant variation among patients who received EV compared to patients who received CV. The purpose of this meta-analysis is to compare mortality at 1-year and MACCE outcomes of TAVR procedures performed using EV versus CV on studies that assessed both valves.
2
Materials and methods
This meta-analysis was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis and Meta-Analysis of Observational Studies in Epidemiology statements for reporting systematic reviews. General guidelines of Cochrane Handbook for Systematic Reviews of Interventions, version 5.1.0 were used in developing methodology and meta-analysis was conducted in adherence to these guidelines . We searched the National Library of Medicine PubMed, National Institute of Health clinical trials registry and the Cochrane Central Register of Controlled Trials to include clinical studies comparing the mortality and MACCE from TAVR procedures using EV and CV. Studies were included if conducted during the period of January 2000 through December 2014. The key words used for searching studies were “transcatheter”, “aortic valve”, “aortic stenosis”, “TAVR”, “Edwards valve”, “CoreValve”, “Transcatheter aortic valve implantation (TAVI)”, “TAVI” “MACCE”, and “mortality”. In addition to our computerized search, we manually reviewed the reference lists and related articles of all retrieved studies to complete our search. Two independent authors (HBP and NB) reviewed all titles from the search results and articles were selected for final data extraction. Selection process was outlined in Fig. 1 .
Studies comparing outcomes of TAVR procedures using EV and CV were included in this meta-analysis. To be selected for analysis, a study had to meet all inclusion criteria: (1) Study must compare outcomes of TAVR procedures using EV and CV performed in patients with severe AS, (2) Study must report at least one of the following MACCE outcomes: all-cause mortality (in-hospital, 30-day and 1-year), cardiovascular mortality, myocardial infarction (MI), stroke, major vascular complications, major bleeding events, incidence of new permanent pacemaker (PPM) placement, and new onset left bundle branch block (LBBB). Studies that did not meet any of the above criteria were excluded.
After identifying all relevant articles, we extracted data from each study including authors, year, design, sample size, follow up duration, types of valve placed, types of TAVR procedure, baseline clinical characteristics of patient population, baseline logistic EuroSCORE representing peri-operative risk and post-procedural outcomes. End points extracted were procedural success rate, all-cause mortality (in hospital, 30-day and 1-year), cardiovascular mortality, MI, stroke, major vascular complications and major bleeding events. The main objective of this study was to evaluate mortality and MACCE outcomes between EV and CV. Two reviewers (HBP and NB) independently extracted data and assessed outcomes. The inter-rater agreement was 90%, and disagreements were resolved by consensus.
The quality of the included studies in present analysis was assessed using the Newcastle-Ottawa quality assessment scale for cohort studies ( http://www.ohri.ca/programs/clinical_epidemiology/oxford.htm ). Briefly, studies were quoted using pre-specified items on patients’ selection (representativeness and selection of patients, ascertainment of exposure), comparability of cohorts, and assessment of outcomes (recording, adequacy of follow-up). Ratings for each item were added to provide a study quality score (maximal score, 9). Two independent reviewers performed the Newcastle-Ottawa Scale grading. Discrepancies were solved on consensus basis.
The mean difference (MD) or odds ratio (OR) across all studies with corresponding 95% confidence interval (CI) was calculated for each endpoint by using RevMan 5.1 statistical software for continuous and dichotomous outcomes respectively (The Cochrane Collaboration, Copenhagen, Denmark). A subgroup meta-analysis was performed for all outcomes from studies that used Valve Academic Research Consortium (VARC) or VARC-2 criteria to define endpoints. Heterogeneity of the studies was assessed for each endpoint. Studies that were homogeneous for an endpoint were analyzed by the Mantel–Haenszel fixed effect model, and studies that were heterogeneous for an endpoint were analyzed by the random effect model. A p value of < 0.05 was considered to be statistically significant. Publication bias was also analyzed using a funnel plot method.
2
Materials and methods
This meta-analysis was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis and Meta-Analysis of Observational Studies in Epidemiology statements for reporting systematic reviews. General guidelines of Cochrane Handbook for Systematic Reviews of Interventions, version 5.1.0 were used in developing methodology and meta-analysis was conducted in adherence to these guidelines . We searched the National Library of Medicine PubMed, National Institute of Health clinical trials registry and the Cochrane Central Register of Controlled Trials to include clinical studies comparing the mortality and MACCE from TAVR procedures using EV and CV. Studies were included if conducted during the period of January 2000 through December 2014. The key words used for searching studies were “transcatheter”, “aortic valve”, “aortic stenosis”, “TAVR”, “Edwards valve”, “CoreValve”, “Transcatheter aortic valve implantation (TAVI)”, “TAVI” “MACCE”, and “mortality”. In addition to our computerized search, we manually reviewed the reference lists and related articles of all retrieved studies to complete our search. Two independent authors (HBP and NB) reviewed all titles from the search results and articles were selected for final data extraction. Selection process was outlined in Fig. 1 .
Studies comparing outcomes of TAVR procedures using EV and CV were included in this meta-analysis. To be selected for analysis, a study had to meet all inclusion criteria: (1) Study must compare outcomes of TAVR procedures using EV and CV performed in patients with severe AS, (2) Study must report at least one of the following MACCE outcomes: all-cause mortality (in-hospital, 30-day and 1-year), cardiovascular mortality, myocardial infarction (MI), stroke, major vascular complications, major bleeding events, incidence of new permanent pacemaker (PPM) placement, and new onset left bundle branch block (LBBB). Studies that did not meet any of the above criteria were excluded.
After identifying all relevant articles, we extracted data from each study including authors, year, design, sample size, follow up duration, types of valve placed, types of TAVR procedure, baseline clinical characteristics of patient population, baseline logistic EuroSCORE representing peri-operative risk and post-procedural outcomes. End points extracted were procedural success rate, all-cause mortality (in hospital, 30-day and 1-year), cardiovascular mortality, MI, stroke, major vascular complications and major bleeding events. The main objective of this study was to evaluate mortality and MACCE outcomes between EV and CV. Two reviewers (HBP and NB) independently extracted data and assessed outcomes. The inter-rater agreement was 90%, and disagreements were resolved by consensus.
The quality of the included studies in present analysis was assessed using the Newcastle-Ottawa quality assessment scale for cohort studies ( http://www.ohri.ca/programs/clinical_epidemiology/oxford.htm ). Briefly, studies were quoted using pre-specified items on patients’ selection (representativeness and selection of patients, ascertainment of exposure), comparability of cohorts, and assessment of outcomes (recording, adequacy of follow-up). Ratings for each item were added to provide a study quality score (maximal score, 9). Two independent reviewers performed the Newcastle-Ottawa Scale grading. Discrepancies were solved on consensus basis.
The mean difference (MD) or odds ratio (OR) across all studies with corresponding 95% confidence interval (CI) was calculated for each endpoint by using RevMan 5.1 statistical software for continuous and dichotomous outcomes respectively (The Cochrane Collaboration, Copenhagen, Denmark). A subgroup meta-analysis was performed for all outcomes from studies that used Valve Academic Research Consortium (VARC) or VARC-2 criteria to define endpoints. Heterogeneity of the studies was assessed for each endpoint. Studies that were homogeneous for an endpoint were analyzed by the Mantel–Haenszel fixed effect model, and studies that were heterogeneous for an endpoint were analyzed by the random effect model. A p value of < 0.05 was considered to be statistically significant. Publication bias was also analyzed using a funnel plot method.
3
Results
Twenty seven studies met the inclusion criteria and were included for the analysis . Literature search and the selection process were shown in Fig. 1 . Studies overview, baseline patient characteristics, criteria used to define outcomes and study quality assessment are included in Table 1 . This meta-analysis included a total of 12,249 patients with severe aortic stenosis who were not eligible for surgical aortic valve replacement, underwent TAVR using EV ( n = 5745) and CV ( n = 6504). The publication bias and heterogeneity for each outcome are demonstrated in Table 2 .
| Study | Design | Patient characteristics | Total population | Types of Edwards valve implanted | Follow-up months | Outcome definitions | Study quality with Newcastle-Ottawa scale | Outcomes | ||
|---|---|---|---|---|---|---|---|---|---|---|
| EV Mean (SD or SE) or % | CV Mean (SD or SE) or % | EV | CV | |||||||
| Abdel-Wahab 2014 | CHOICE Randomized trial | Age: 81.9 (6.7) | Age: 79.6 (15.8) | 121 | 120 | XT | 1 | VARC (Reference Leon et al) | 9 | Procedure success, 30-day all-cause mortality, cardiovascular mortality, stroke, major bleeding, major vascular complications, new PPM |
| F: 57% | F: 71.7% | |||||||||
| LES: 21.5 (12.9) | LES: 22.1 (14.7) | |||||||||
| Godino 2010 | Prospective | Age: 80 (6) | Age: 79 (7.5) | 61 | 46 | ES | 6 | Non-VARC | 9 | Procedure success, 30-day all-cause mortality, cardiovascular mortality, stroke, major vascular complications, new PPM placement |
| F: 54% | F: 39% | |||||||||
| LES: 27.1 (16.4) | LES: 26.0 (15.5) | |||||||||
| Roten 2010 | Prospective | Age 83 | Age 84 | 26 | 41 | ES | ≥ 1 | Non-VARC | 9 | New PPM placement and new onset LBBB |
| F: 58% | F: 51% | |||||||||
| LES: 23 (16–38) | LES 21 (12–31) | |||||||||
| Attias 2010 | Prospective | Age: 81 (9) | Age: 79 (7) | 72 | 11 | ES | ≥ 12 | Non-VARC | 9 | Procedure success, in-hospital mortality, 30-day all-cause mortality, stroke, major vascular complications, new PPM |
| F: 50% | F: 27% | |||||||||
| LES 26 (15) | LES: 23 (8) | |||||||||
| Tchetche 2010 | Prospective | Age 80 (4) | Age 83 (4.2) | 24 | 21 | ES | 1 | Non-VARC | 8 | Procedure success, in-hospital and 30-day all-cause mortality, MI, stroke, major vascular complications, new PPM |
| F: 30% | F: 38.1% | |||||||||
| LES 22.5 (6.9) | LES 28.2 (9.1) | |||||||||
| Moat 2011 | Prospective UK TAVI registry | Age: 82.6 (6.7) | Age: 81.3 (7.4 | 410 | 452 | ES | 12 | Non-VARC | 8 | 30-day and 1 year all-cause mortality, MI, stroke, major vascular complications, new PPM |
| F: 47.1% | F: 42% | |||||||||
| LES: 18.5 (12.4–27.7) | LES: 18.1 (11.1–27.9) | |||||||||
| Bosmans 2011 | Prospective Belgian TAVI registry | Age: 83.6 (6), | Age: 82 (6) | 187 | 141 | ES | 12 | Not mentioned | 8 | Procedure success, 30-day and 1 year all-cause mortality, stroke, new PPM |
| F: 53% | F: 56% | |||||||||
| LES: 30 (16) | LES: 25 (15) | |||||||||
| Hernandez-Antolin 2011 | Prospective | Age: 82 (6) | Age: 84 (5) | 50 | 26 | Cribier Edwards, ES and XT | ≥ 12 | Not mentioned | 9 | In-hospital, 30-day and 1 year all-cause mortality, cardiovascular mortality, stroke, major vascular complications, new PPM |
| F: 68% | F: 54% | |||||||||
| LES: 17.3 (7.9) | LES: 18.6 (10) | |||||||||
| Eltchaninoff 2011 | Prospective FRANCE registry | Age: 83.2 (7.3) | Age: 82.5 (5.9) | 166 | 78 | ES | 1 | Not mentioned | 9 | 30-day all-cause mortality, stroke, major bleeding, major vascular complications, new PPM |
| F: 44 % | F: 51.5% | |||||||||
| LES: 25.6 (11.3) | LES: 24.7 (11.2) | |||||||||
| Zahn 2011 | Prospective German registry | No baseline data reported data by valve type | No baseline data reported data by valve type | 100 | 565 | ES | 1 | Not mentioned | Insufficient data | New PPM |
| Houthuizen 2012 | Prospective registry | No baseline data reported data by valve type | No baseline data reported data by valve type | 292 | 387 | ES | 15 | Non mentioned | Insufficient data | New onset LBBB |
| Liang 2012 | Prospective | Age: 81 (6) | Age: 79 (1) | 15 | 38 | ES | 21 | Not mentioned | 9 | New PPM placement and new onset LBBB |
| F: 60% | F: 37% | |||||||||
| LES: 30 (12) | LES: 22 (15) | |||||||||
| Gilard 2012 | Prospective FRANCE-2 registry | Age: 82.9 (7.2) | Age: 82.3 (7.2) | 2107 | 1043 | ES and XT | 12 | VARC | 9 | Procedure success, 30-day and 1 year all-cause mortality, cardiovascular mortality, MI, stroke, major bleeding, major vascular complications, new PPM |
| F: 53.5% | F: 40% | |||||||||
| LES: 22.2 (14.3) | LES 21.3 (14.3) | |||||||||
| Chieffo 2013 | Prospective PRAGMATIC plus | Age: 81.6 (7.3) | Age: 80.9 (6.7) | 340 | 453 | ES | 12 | VARC | 9 | Procedure success, 30-day and 1 year all-cause mortality, cardiovascular mortality, MI, stroke, major bleeding, major vascular complications, new PPM |
| F: 50.6% | F: 44.6% | |||||||||
| LES: 23.0 (13.8) | LES: 21.4 (12.6) | |||||||||
| Franzoni 2013 | Prospective | Age: 79.7 (8.4) | Age: 78.9 (6.1) | 151 | 87 | ES | 12 | EKG | 9 | New onset LBBB |
| F: 40.4 % | F: 43.7% | |||||||||
| LES: 22.6 (15.9) | LES: 22.05 (19.9) | |||||||||
| Goldenberg 2013 | Prospective | No baseline data reported data by valve type | No baseline data reported data by valve type | 66 | 125 | ES and XT | 12 | WHO and International Society and Federation for Cardiology Task Force | Insufficient data | New PPM |
| Schewel 2013 | Prospective | Age: 81.6% (6.5) | Age 79.5 (7.2) | 133 | 222 | ES and XT | 1 | VARC | 8 | Procedure success, 30-day all-cause mortality |
| F: 52.4% | F: 47.5% | |||||||||
| LES 23.7 (13.7) | LES: 26.51 (16.3) | |||||||||
| Staubach 2013 | Prospective German TAVI registry | Not available as per valve type | Not available as per valve type | 249 | 1078 | ES | 1 | Non-VARC | Insufficient data | 30-day all-cause mortality, MI, stroke, new PPM |
| Seiffert 2013 | Prospective | ES-TA | Age: 78.2 (75.9–80.5)s F: | 281 | 45 | ES and XT | 1 | VARC | 7 | Procedure success, 3-day all-cause mortality, cardiovascular mortality, MI, stroke, major bleeding, major vascular complications, new PPM |
| Age: 80.5 (79.5–81.5) | ||||||||||
| F: 56.5% | 35.6% | |||||||||
| LES: 25.5 (23.6–27.5) ES-TF: | LES: 21.8 (17.4–26.1) | |||||||||
| Age: 81.6 (79.9–83.3) | ||||||||||
| F: 62.5% | ||||||||||
| LES: 18.3 (15.1–21.5) | ||||||||||
| Spargias 2013 | Prospective ATHENS TAVR registry | Age: 79 (9) | Age: 81 (7) | 59 | 67 | XT | 1 | VARC | 9 | 30-day all-cause mortality, stroke, major bleeding, major vascular complications, new PPM |
| F: 68% | F: 51% | |||||||||
| LES: 23 (12) | LES: 26 (14) | |||||||||
| Watanabe 2013 | Prospective | Age: 83.0 (7.4) | Age: 83.2 (7) | 170 | 150 | ES | 12 | VARC-2 | 9 | Procedure success, 30-day all-cause mortality, stroke, major vascular complications, new PPM |
| F: 64.1 % | F: 44.7% | |||||||||
| LES: 21.3 (12.2) | LES: 22.9 (11.6 %) | |||||||||
| Gensas 2014 | Prospective Brazilian registry | No baseline data reported data by valve type | No baseline data reported data by valve type | 50 | 303 | XT | Not specified | VARC-2 | Insufficient data | New PPM |
| Kasel 2014 | Prospective | Age: 81.54 (5.2) | Age: 79.82 (6.6) | 50 | 50 | XT | 1 | VARC (JACC) | 9 | Procedure success, in-hospital and 30-day all-cause mortality, MI, stroke, major bleeding, new PPM |
| F: 82% | M: 52% | |||||||||
| LES: 23.23 (15.42) | LES: 20.73 (13) | |||||||||
| Tarsia 2014 | Prospective | No baseline data reported data by valve type | No baseline data reported data by valve type | 56 | 53 | ES and XT | 18 | VARC-2 | Insufficient data | Procedure success, 30-day all-cause mortality, cardiovascular mortality, MI, stroke, major bleeding, major vascular complications |
| Abdel-Wahab 2014 | Prospective | Age: 82.8 (5.7) | Age: 81.2 (7.2) | 118 | 276 | XT | 12 | VARC and non-VARC | 8 | Procedure success, 1 year all-cause mortality |
| F: 75.4% | F: 54.7% | |||||||||
| LES: 20.61 (13.93) | LES: 22.27 (13.39) | |||||||||
| Wenaweser 2014 | Prospective Swiss TAVI registry | No baseline data reported data by valve type | No baseline data reported data by valve type | 232 | 324 | XT | 1 | VARC | Insufficient data | 30-day all-cause mortality, cardiovascular mortality, MI, stroke, major bleeding, major vascular complications, new PPM |
| Greif 2014 | Prospective | Age: 80.99 (7.29) | Age: 81.14 (6.56) | 159 | 302 | XT | 12 | VARC | 8 | 30-day all-cause mortality, cardiovascular mortality, MI, stroke, major bleeding, major vascular complications, new PPM |
| F: 62.89% | F: 52.32% | |||||||||
| LES 18.46 (9.63) | LES: 22.7 (11.65) | |||||||||
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