A Meta-Analysis of Mortality and Major Adverse Cardiovascular and Cerebrovascular Events in Patients Undergoing Transfemoral Versus Transapical Transcatheter Aortic Valve Implantation Using Edwards Valve for Severe Aortic Stenosis Hemang B. Panchal, MD, MPH a , Vatsal Ladia, MD a , Parthiv Amin, MD a , Parthavkumar Patel, MBBS, MPH b , Sreenivas P. Veeranki, MBBS, DrPH c , Kais Albalbissi, MD a , and Timir Paul, MD, PhD a, * The purpose of this meta-analysis was to compare 1 year mortality and major adverse cardiovascular and cerebrovascular events between transfemoral (TF) transcatheter aortic valve implantation (TAVI) and transapical (TA) TAVI performed using Edwards valves. PubMed, Embase, and the Cochrane Center Register of Controlled Trials were searched for studies published from January 2000 through March 2014. Seventeen studies met the inclusion criteria and were included in the analysis. This meta-analysis included total of 2,978 patients with severe aortic stenosis not eligible for traditional surgical procedures who underwent TF TAVI (n [ 1,465) or TA TAVI (n [ 1,513). End points were in-hospital, 30-day, and 1-year all-cause mortality, stroke, myocardial infarction, major bleeding, and major vascular complications. Odds ratios (ORs) with 95% confidence interval (CIs) were computed, and p values <0.05 were considered to indicate statistical significance. The studies were homogenous for all outcomes except 1-year mortality. There was no significant difference between the TF and TA TAVI groups for 1-year mortality (OR 0.64, 95% CI 0.34 to 1.2, p [ 0.16), incidence of stroke (OR 1.14, 95% CI 0.76 to 1.71, p [ 0.52), incidence of myocardial infarction (OR 0.62, 95% CI 0.23 to 1.7, p [ 0.35), and incidence of bleeding events (OR 0.76, 95% CI 0.51 to 1.14, p [ 0.19). Thirty-day all-cause mortality was significantly less with TF TAVI compared with TA TAVI (OR 0.59, 95% CI 0.45 to 0.76, p <0.0001). Major vascular events were significantly higher in the TF TAVI group compared with the TA TAVI group (OR 4.33, 95% CI 3.14 to 5.97, p <0.00001). In conclusion, the results of this meta-analysis of 2,978 patients revealed that TA TAVI had similar 1-year major adverse cardiovascular and cerebrovascular events, fewer major vascular complica- tions, but higher 30-day mortality compared with TF TAVI. In patients with contraindi- cations to TF TAVI, TA TAVI is a reasonable option, although further randomized trials are warranted for evaluating long-term clinical outcomes between TF and TA TAVI. Ó 2014 Elsevier Inc. All rights reserved. (Am J Cardiol 2014;114:1882e1890) Severe aortic stenosis (AS) is the most common form of heart valve disease that affects the elderly population when not associated with genetic abnormalities. 1 Symptomatic AS or a left ventricular ejection fraction <50% is an indication for valve replacement. 2 Because nearly 1/3 of patients with se- vere AS are denied traditional surgical aortic valve replace- ment (SAVR) because of co-morbidities and expected poor surgical outcomes, transcatheter aortic valve implantation (TAVI) has been compared with surgical replacement in the past. 3 Benefits of TAVI in high-risk patients who are not eligible for surgical replacement are well documented. 4,5 A recent meta-analysis compared TAVI with SAVR and demonstrated that TAVI is superior to SAVR for major bleeding complications and noninferior to SAVR for post- procedural myocardial infarctions (MIs) and cerebrovascular events. 3 TAVI is performed using transfemoral (TF), trans- apical (TA), subclavian, and transaortic approaches. TF TAVI is a retrograde approach, whereas TA TAVI is an anterograde approach with apical minithoracotomy, which poses more risk for mortality and morbidity. 6 TF TAVI is the preferred approach, given less inherent risk for periprocedural com- plications by avoiding more invasive steps such as mini- thoracotomy and left ventricular puncture. The purpose of this meta-analysis was to compare mortality and major adverse cardiovascular and cerebrovascular events (MACCEs) between TF and TA TAVI performed using Edwards valves. Methods This meta-analysis was performed in accordance with the Preferred Reporting Items for Systematic Reviews and a Department of Internal Medicine, East Tennessee State University, Johnson City, Tennessee; b Department of Pathology, University of Tennessee, Knoxville, Tennessee; and c Division of Epidemiology, Department of Preventive Medicine and Community Health, University of Texas Medical Brach, Galveston, Texas. Manuscript received May 31, 2014; revised manuscript received and accepted September 21, 2014. See page 1889 for disclosure information. *Corresponding author: Tel: (423) 979-4100; fax: (423) 979-4134. E-mail address: [email protected](T. Paul). 0002-9149/14/$ - see front matter Ó 2014 Elsevier Inc. All rights reserved. www.ajconline.org http://dx.doi.org/10.1016/j.amjcard.2014.09.029
Transcript
A Meta-Analysis of Mortality and Major Adverse
Cardiovascular and Cerebrovascular Events in Patients
Undergoing Transfemoral Versus Transapical Transcatheter Aortic
Valve Implantation Using Edwards Valve for Severe Aortic Stenosis
The purpose of this meta-analysis was to compare 1 year mortality and major adversecardiovascular and cerebrovascular events between transfemoral (TF) transcatheter aorticvalve implantation (TAVI) and transapical (TA) TAVI performed using Edwards valves.PubMed, Embase, and the Cochrane Center Register of Controlled Trials were searched forstudies published from January 2000 through March 2014. Seventeen studies met theinclusion criteria and were included in the analysis. This meta-analysis included total of2,978 patients with severe aortic stenosis not eligible for traditional surgical procedures whounderwent TF TAVI (n [ 1,465) or TA TAVI (n [ 1,513). End points were in-hospital,30-day, and 1-year all-cause mortality, stroke, myocardial infarction, major bleeding, andmajor vascular complications. Odds ratios (ORs) with 95% confidence interval (CIs) werecomputed, and p values <0.05 were considered to indicate statistical significance. Thestudies were homogenous for all outcomes except 1-year mortality. There was no significantdifference between the TF and TA TAVI groups for 1-year mortality (OR 0.64, 95% CI 0.34to 1.2, p[ 0.16), incidence of stroke (OR 1.14, 95% CI 0.76 to 1.71, p[ 0.52), incidence ofmyocardial infarction (OR 0.62, 95% CI 0.23 to 1.7, p [ 0.35), and incidence of bleedingevents (OR 0.76, 95% CI 0.51 to 1.14, p [ 0.19). Thirty-day all-cause mortality wassignificantly less with TF TAVI compared with TA TAVI (OR 0.59, 95% CI 0.45 to 0.76,p <0.0001). Major vascular events were significantly higher in the TF TAVI group comparedwith the TA TAVI group (OR 4.33, 95% CI 3.14 to 5.97, p <0.00001). In conclusion, theresults of this meta-analysis of 2,978 patients revealed that TA TAVI had similar 1-yearmajor adverse cardiovascular and cerebrovascular events, fewer major vascular complica-tions, but higher 30-day mortality compared with TF TAVI. In patients with contraindi-cations to TF TAVI, TA TAVI is a reasonable option, although further randomized trials arewarranted for evaluating long-term clinical outcomes between TF and TA TAVI. � 2014Elsevier Inc. All rights reserved. (Am J Cardiol 2014;114:1882e1890)
Severe aortic stenosis (AS) is the most common form ofheart valve disease that affects the elderly population whennot associated with genetic abnormalities.1 Symptomatic ASor a left ventricular ejection fraction<50% is an indication forvalve replacement.2 Because nearly 1/3 of patients with se-vere AS are denied traditional surgical aortic valve replace-ment (SAVR) because of co-morbidities and expected poorsurgical outcomes, transcatheter aortic valve implantation(TAVI) has been compared with surgical replacement in thepast.3 Benefits of TAVI in high-risk patients who are not
eligible for surgical replacement are well documented.4,5 Arecent meta-analysis compared TAVI with SAVR anddemonstrated that TAVI is superior to SAVR for majorbleeding complications and noninferior to SAVR for post-procedural myocardial infarctions (MIs) and cerebrovascularevents.3 TAVI is performed using transfemoral (TF), trans-apical (TA), subclavian, and transaortic approaches. TFTAVIis a retrograde approach, whereas TA TAVI is an anterogradeapproach with apical minithoracotomy, which poses morerisk for mortality and morbidity.6 TF TAVI is the preferredapproach, given less inherent risk for periprocedural com-plications by avoiding more invasive steps such as mini-thoracotomy and left ventricular puncture. The purpose of thismeta-analysis was to compare mortality and major adversecardiovascular and cerebrovascular events (MACCEs)between TF and TA TAVI performed using Edwards valves.
Methods
This meta-analysis was performed in accordance withthe Preferred Reporting Items for Systematic Reviews and
aDepartment of Internal Medicine, East Tennessee State University,
Johnson City, Tennessee; bDepartment of Pathology, University of
Tennessee, Knoxville, Tennessee; and cDivision of Epidemiology,
Department of Preventive Medicine and Community Health, University of
Texas Medical Brach, Galveston, Texas. Manuscript received May 31,
2014; revised manuscript received and accepted September 21, 2014.
Meta-Analyses7 and Meta-Analysis of Observational Studiesin Epidemiology8 statements for reporting systematic re-views. General guidelines from the Cochrane Handbook forSystematic Reviews of Interventions, version 5.0.2 were usedin developing methods, and the meta-analysis was conductedin adherence to these guidelines.8 We searched the NationalLibrary of Medicine PubMed, National Institutes of Healthclinical trials registry (ClinicalTrials.gov), and the CochraneCentral Register of Controlled Trials to include clinicalstudies comparing mortality and MACCEs between TF andTA TAVI for severe AS. Studies were included if conductedfrom January 2000 throughMarch 2014. The key words usedfor searching studies were “transcatheter,” “aortic valve,”“aortic stenosis,” “aortic valve replacement,” “TAVI,”“transfemoral,” “transapical,” and “transcatheter aortic valvereplacement (TAVR).” In addition to our computerizedsearch, we manually reviewed the reference lists and relatedlinks of all retrieved reports to complete our search. Two in-dependent investigators (HBP and VL) reviewed all titlesfrom the search results, and reports were selected for final dataextraction. The selection process is outlined in Figure 1.
Studies comparing outcomes between TF and TA TAVIprocedures using Edwards valves were included in this meta-analysis. To be selected for analysis, a study had to meet allinclusion criteria: (1) the study must compare TF and TATAVI performed in patients with severe AS, and (2) the studymust report�1 of the followingMACCE outcomes: all-causemortality (in-hospital, 30-day, and 1-year), MI, stroke, majorvascular events, and major bleeding events. Studies that didnot meet any of these criteria were excluded.
After identifying all relevant reports, we extracted datafrom each study, including investigators, year, design, samplesize, follow-up duration, types of valves placed, types ofTAVI procedures, baseline clinical characteristics of thepatient population, baseline logistic European System forCardiac Operative Risk Evaluation (EuroSCORE) repre-senting perioperative risk, and postprocedural outcomes. Endpoints extracted were all-cause mortality (in-hospital, 30-day,and 1-year), MI, stroke, major vascular events, and majorbleeding events. The main objective of this study was toevaluate mortality and MACCE outcomes. Two reviewers(HBP and VL) independently extracted data and assessedoutcomes. Interrater agreement was 90%, and disagreementswere resolved by consensus.
The quality of the included studies in present analysis wasassessed using the Newcastle-Ottawa Scale for qualityassessment of cohort studies (http://www.ohri.ca/programs/clinical_epidemiology/oxford.htm). Briefly, studies werequoted using prespecified items on patient selection (repre-sentativeness and selection of patients, ascertainment ofexposure), comparability of cohorts, and assessment of out-comes (recording, adequacy of follow-up). Ratings for eachitem were added to provide a study quality score (maximalscore 9). Two independent reviewers performed Newcastle-Ottawa Scale grading. Discrepancies were solved byconsensus.
The mean difference or odds ratio (OR) across all studieswith the corresponding 95% confidence interval (CI) wascalculated for each end point by using RevMan version 5.1(The Cochrane Collaboration, Copenhagen, Denmark) forcontinuous and dichotomous outcomes, respectively. Het-erogeneity of the studies was assessed for each end point.Studies that were homogenous for an end point were analyzedby using the Mantel-Haenszel fixed-effect model, and studiesthat were heterogenous for an end point were analyzedby using the random-effect model. Publication bias wasalso analyzed using a funnel-plot method. In addition, metaeregression analyses were conducted to determine whethercomparisons of mortality and MACCEs between TF and TATAVI were modulated by prespecified factors, includinggender, chronic obstructive pulmonary disease, coronaryartery disease (CAD), Society of Thoracic Surgeons (STS)score, and logistic EuroSCORE. Comparison ofMI outcomesbetween TF and TA TAVI was not performed by prespecifiedfactors, because of inadequate data. These metaeregressionanalyses were performed using SAS version 9.2 (SAS Insti-tute Inc., Cary, North Carolina). A p value <0.05 wasconsidered to indicate statistical significance.
Results
Seventeen studies met the inclusion criteria and wereincluded for the analysis.9e25 The search and selection pro-cess is shown in Figure 1. Although we searched for studiespublished throughMarch 2014, themost recent study that metour inclusion and exclusion criteria was published in 2012.Study overview and baseline patient characteristics are listedin Table 1. This meta-analysis included total of 2,978 patientswith severe AS who were not eligible for SAVR and under-went TF TAVI (n¼ 1,465) or TA TAVI (n¼ 1,513). Follow-up was nearly 99% complete for included subjects in allstudies. Study quality assessment was provided in Table 1.Logistic EuroSCORE was compared between the 2 groups inall but 4 studies.14,19,20,23 Publication bias and heterogeneityfor each outcome are listed in Table 2.
In-hospital mortality was not significantly different be-tween the TF and TA TAVI groups (p ¼ 0.19; Figure 2). Nosignificant differences in in-hospital mortality between TFand TA TAVI were identified when modulated by the effectsof the prespecified factors gender, chronic obstructive pul-monary disease, CAD, STS score, and logistic EuroSCORE.Thirty-day all-cause mortality was significantly lower withTF TAVI compared with TA TAVI (p <0.0001; Figure 3).Similar significant differences were identified when modu-lated by gender (p ¼ 0.004), CAD (p ¼ 0.005), and logistic
Figure 1. Study selection process.
Valvular Heart Disease/TF Versus TA TAVI MACCE and Mortality 1883
CAD ¼ coronary artery disease; CKD ¼ chronic kidney disease; COPD ¼ chronic obstructive pulmonary disease; D ¼ day; F ¼ female; IHM ¼ in-hospital mortality; LES ¼ logistic EuroSCORE; LVEF ¼
left ventricular ejection fraction; MI ¼ myocardial infarction; MVC ¼ major vascular complications; STS ¼ Society of Thoracic Surgeons score; TA ¼ transapical; TF ¼ transfemoral; TIA ¼ transient ischemic
attack; yr ¼ year.
* Latest follow-up mentioned in the study was 1 year. Patients were subsequently followed-up on a yearly basis; however the final follow-up duration was not mentioned.
Valvu
larHeartDisea
se/TFVersu
sTATAVIMACCEandMorta
lity1885
EuroSCORE (p ¼ 0.04). There was no significant differencein all-causemortality at 1 year between TF and TATAVI (p¼0.16; Figure 4), but whenmodulated by logistic EuroSCORE,all-cause mortality at 1 year was significantly lower with TFTAVI compared with TA TAVI (p¼ 0.0011). The incidenceof stroke was not significantly different between the TF andTA TAVI groups (p ¼ 0.52; Figure 5), with no significant
differences identified when modulated by the effects of theprespecified factors gender, CAD, STS score, and logisticEuroSCORE. Similarly, the incidence of MI was not statis-tically significant between the TF and TA TAVI groups (p¼0.35; Figure 6). Major vascular events were significantlymore frequent in the TF TAVI group compared with the TATAVI group (p <0.00001; Figure 7), and similar significant
Table 2
Test of heterogeneity and publication bias for each outcome based on funnel plot method
differences were identified when modulated by gender (p ¼
0.001), CAD (p¼ 0.0002), STS score (p¼ 0.03), and logisticEuroSCORE (p¼ 0.01). Bleeding events between the TF andTA TAVI groups were not significantly different (p ¼ 0.19;Figure 8), with no significant differences identified whenmodulated by the effects of prespecified factors.
Discussion
Several studies have shown variation in mortality after TFand TA TAVI procedures. TA TAVI is considered to be moreinvasive, with an anterolateral minithoracotomy and leftventricular puncture; in contrast, manipulations in the aorticarch associated with TF TAVI are completely avoided. Ourstudy demonstrated higher 30-day mortality in the TA TAVIgroup. One-year all-cause mortality was similar between theTF and TA TAVI groups. However, when modulated withlogistic EuroSCORE, 1-year all-cause mortality was higher in
the TA TAVI group compared with the TF TAVI group. Thepopulations for TA and TF TAVI procedures have variedwidely in many studies.6,14,19 The TF approach was preferredas an initial approach for TAVI because it is less invasivecompared with the TA approach. However, patients withsignificant peripheral vascular disease, tortuous or relativelysmaller diameter femoral or iliac vessels, calcified vessels,or unfavorable aortic anatomy underwent TAVI with theTA approach. Additionally, these patients had moreco-morbidities that may increase their procedural and peri-procedural risk. Higher logistic EuroSCORE in the TA groupmight have contributed to higher all-cause mortality. Otherpossible explanation for increased 30-day mortality with theTA approach could include the more invasive nature of thisapproach and its steeper learning curve.
Studies have shown conflicting results in stroke ratebetween TF and TA TAVI groups. It has been previouslysuggested that the stroke rate for TF TAVI was higher than
Figure 4. Meta-analysis comparison of 1-year mortality between TF and TA TAVI. M-H ¼ Mantel-Haenszel.
Figure 5. Meta-analysis comparison of incidence of stroke between TF and TA TAVI. M-H ¼ Mantel-Haenszel.
Valvular Heart Disease/TF Versus TA TAVI MACCE and Mortality 1887
for TA TAVI, probably because of the passage of 22Fr or24Fr catheters around the aortic arch.6 However, our studydid not show any difference in stroke rates between the TFand TA groups. This could be secondary to higher risk forischemic stroke in the TA group because of the likelihood ofhigher atherosclerotic disease in the carotid arteries, causingpoor cerebral circulation during temporary hypotensioninduced by rapid pacing, which balanced out the higher
incidence of catheter-induced embolic stroke in the TFgroup. The lack of differences between the TA and TF ap-proaches might also suggest that mechanical stress of theaortic valve during balloon valvuloplasty and valve im-plantation might cause embolism of calcified particles of theaortic valve, which might be the main mechanism for ce-rebral embolism. Careful patient selection, device prepara-tion, and optimal device progression and positioning may
Figure 7. Meta-analysis comparison of incidence of major vascular complications between TF and TA TAVI. M-H ¼ Mantel-Haenszel.
Figure 8. Meta-analysis comparison of incidence of major bleeding events between TF and TA TAVI. M-H ¼ Mantel-Haenszel.
Figure 6. Meta-analysis comparison of incidence of MI between TF and TA TAVI. M-H ¼ Mantel-Haenszel.
1888 The American Journal of Cardiology (www.ajconline.org)
further reduce the risk for embolization or stroke. Anti-coagulation during the procedure to reach a target activatedclotting time of >250 seconds is generally suggested toprevent stroke. Empiric dual-oral antiplatelet therapy isgenerally recommended for 3 to 6 months, followed bylong-term daily low-dose aspirin.26 Onsea et al27 used thenew embolic deflection device during TF and TA TAVI in15 patients, with 100% success in preventing periproceduralstroke.
In the currently available published research, there hasbeen an association between vascular complications and 30-day and 1-year mortality in patients who underwent TFTAVI.28 The development of smaller sized delivery system,better preprocedural screening, and high-volume operatorexperience can improve periprocedural outcomes of TFTAVI.15,23,26 As expected and shown in previous studies,major vascular complications were lower in the TA group inour study compared with the TF group. However, majorvascular complications in the TA group were a significantpredictor of mortality (p <0.001).22 Major vascular com-plications such as femoral or iliac vessel perforation ordissection, thrombosis or occlusion, and bleeding necessi-tating endovascular or surgical treatment have been reportedto range from 9% to 20% with the TF approach.29e34
Reexploration for postprocedural thoracic bleeding hasbeen reported to range from 8% to 14% with the TAapproach.35e37 Major bleeding events in TAVI are poten-tially life threatening and require interventional or surgicaltreatment. Panchal et al3 demonstrated a reduced rate ofmajor bleeding events with TAVI compared with SAVR,which is clearly an advantage of TAVI. Interestingly, ourstudy demonstrated similar bleeding events between the 2approaches to TAVI.
Our meta-analysis had several limitations. The baselinecharacteristics between the 2 groups could not be comparedentirely, because of the inherent nature of the meta-analysis.Because of the meta-analytic nature of the study, we wereunable to evaluate the effects of gender, race, and ethnicbackground on the measured outcomes. In addition, there isa potential for publication bias. Many of these trials weresmall trials with limited ability to assess outcomes. Theoverall follow-up period was short to intermediate. Poweranalysis was not performed in most of the studies, andmany of these studies may have been underpowered. Therewas no randomized controlled trial available for subgroupanalysis. The logistic EuroSCORE was used in our analysisfor baseline risk stratification of patients. Although the lo-gistic EuroSCORE 2 is a better scoring systems than thelogistic EuroSCORE, we were unable to use it, because itwas not available uniformly across the studies. Most studieseither did not provide definitions of outcomes or did notmention using the Valve Academic Research Consortiumdefinitions for outcomes assessment.38 Because of the un-availability of combined MACCE outcomes data in theoriginal studies, we were unable to include them in ouranalysis.
Disclosures
The authors have no conflicts of interest to disclose.
1. Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enri-quez-Sarano M. Burden of valvular heart diseases: a population-basedstudy. Lancet 2006;368:1005e1011.
2. Bonow RO, Carabello BA, Chatterjee K, de Leon AC Jr, Faxon DP,Freed MD, Gaasch WH, Lytle BW, Nishimura RA, O’Gara PT,O’Rourke RA, Otto CM, Shah PM, Shanewise JS. 2006 WritingCommittee Members; American College of Cardiology/AmericanHeart Association Task Force. 2008 Focused update incorporated intothe ACC/AHA 2006 guidelines for the management of patients withvalvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines(Writing Committee to Revise the 1998 Guidelines for the Managementof Patients With Valvular Heart Disease): endorsed by the Society ofCardiovascular Anesthesiologists, Society for Cardiovascular Angiog-raphy and Interventions, and Society of Thoracic Surgeons. Circulation2008;118:e523ee661.
3. Panchal HB, Ladia V, Desai S, Shah T, Ramu V. A meta-analysis ofmortality and major adverse cardiovascular and cerebrovascular eventsfollowing transcatheter aortic valve implantation versus surgical aorticvalve replacement for severe aortic stenosis. Am J Cardiol 2013;112:850e860.
4. Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, MakkarRR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M,Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, DouglasPS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, AndersonWN, Leon MB. Two-year outcomes after transcatheter or surgicalaortic-valve replacement. N Engl J Med 2012;366:1686e1695.
5. Latib A, Maisano F, Bertoldi L, Giacomini A, Shannon J, Cioni M,Ielasi A, Figini F, Tagaki K, Franco A, Covello RD, Grimaldi A,Spagnolo P, Buchannan GL, Carlino M, Chieffo A, Montorfano M,Alfieri O, Colombo A. Transcatheter vs surgical aortic valve replace-ment in intermediate-surgical-risk patients with aortic stenosis: a pro-pensity score-matched case-control study. Am Heart J 2012;164:910e917.
6. Bleiziffer S, Ruge H, Mazzitelli D, Schreiber C, Hutter A, Laborde J-C,Bauernschmitt R, Lange R. Results of percutaneous and transapicaltranscatheter aortic valve implantation performed by a surgical team.Eur J Cardiothorac Surg 2009;35:615e620.
7. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, IoannidisJPA, Clarke M, Devereaux PJ, Kleijnen J, Moher D. The PRISMAstatement for reporting systematic reviews and meta-analyses of studiesthat evaluate health care interventions: explanation and elaboration.PLoS Med 2009;6:e1000100.
8. Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D,Moher D, Becker BJ, Sipe TA, Thacker SB. Meta-analysis of obser-vational studies in epidemiology: a proposal for reporting. Meta-Analysis of Observational Studies in Epidemiology (MOOSE) group.JAMA 2000;283:2008e2012.
9. Al-Attar N, Himbert D, Descoutures F, Iung B, Raffoul R, Messika-Zeitoun D, Brochet E, Francis F, Ibrahim H, Vahanian A, Nataf P.Transcatheter aortic valve implantation: selection strategy is crucial foroutcome. Ann Thorac Surg 2009;87:1757e1763.
10. Bosmans JM, Kefer J. Bruyne B De, Herijgers P, Dubois C, LegrandV, Verheye S, Rodrigus I. Procedural, 30-day and one year outcomefollowing CoreValve or Edwards transcatheter aortic valve implanta-tion: results of the Belgian national registry. Interact Cardiovasc
A, Young C, Bapat V, Hancock J, Wilson K, Brickham B, Wendler O,Thomas MR. Transcatheter aortic valve implantation for severe aorticstenosis-a new paradigm for multidisciplinary intervention: a pro-spective cohort study. Am Heart J 2010;160:237e243.
12. Eltchaninoff H, Prat A, Gilard M, Leguerrier A, Blanchard D, FournialG, Iung B, Donzeau-Gouge P, Tribouilloy C, Debrux J-L, Pavie A,Gueret P. Transcatheter aortic valve implantation: early results of theFRANCE (FRench Aortic National CoreValve and Edwards) registry.Eur Heart J 2011;32:191e197.
13. Ewe SH, Delgado V, Ng ACT, Antoni ML. Kley F van der, MarsanNA, Weger A de, Tavilla G, Holman ER, Schalij MJ, Bax JJ. Out-comes after transcatheter aortic valve implantation: transfemoral versustransapical approach. Ann Thorac Surg 2011;92:1244e1251.
14. Gurvitch R, Tay EL, Wijesinghe N, Ye J, Nietlispach F, Wood DA,Lichtenstein S, Cheung A, Webb JG. Transcatheter aortic valve
Valvular Heart Disease/TF Versus TA TAVI MACCE and Mortality 1889
implantation: lessons from the learning curve of the first 270 high-riskpatients. Catheter Cardiovasc Interv 2011;78:977e984.
15. Himbert D, Descoutures F, Al-Attar N, Iung B, Ducrocq G, Détaint D,Brochet E, Messika-Zeitoun D, Francis F, Ibrahim H, Nataf P, Vaha-nian A. Results of transfemoral or transapical aortic valve implantationfollowing a uniform assessment in high-risk patients with aortic ste-nosis. J Am Coll Cardiol 2009;54:303e311.
16. Johansson M, Nozohoor S, Kimblad PO, Harnek J, Olivecrona GK,Sjögren J. Transapical versus transfemoral aortic valve implantation: acomparison of survival and safety. Ann Thorac Surg 2011;91:57e63.
17. Lefèvre T, Kappetein AP, Wolner E, Nataf P, Thomas M, SchächingerV, De Bruyne B, Eltchaninoff H, Thielmann M, Himbert D, RomanoM, Serruys P, Wimmer-Greinecker G. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur HeartJ 2011;32:148e157.
18. Nielsen HHM, Thuesen L, Egeblad H, Poulsen SH, Klaaborg K-E,Jakobsen C-J, Andersen HR, Hjortdal VE. Single center experiencewith transcatheter aortic valve implantation using the EdwardsSAPIENTM Valve. Scand Cardiovasc J 2011;45:261e266.
19. Osten MD, Feindel C, Greutmann M, Chamberlain K, Meineri M,Rubin B, Mezody M, Ivanov J, Butany J, Horlick EM. Transcatheteraortic valve implantation for high risk patients with severe aortic ste-nosis using the Edwards Sapien balloon-expandable bioprosthesis: asingle centre study with immediate and medium-term outcomes.Catheter Cardiovasc Interv 2010;75:475e485.
20. Rodés-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM,Osten M, Natarajan MK, Velianou JL, Martucci G, DeVarennes B,Chisholm R, Peterson MD, Lichtenstein SV, Nietlispach F, Doyle D,DeLarochellière R, Teoh K, Chu V, Dancea A, Lachapelle K, CheemaA, Latter D, Horlick E. Transcatheter aortic valve implantation for thetreatment of severe symptomatic aortic stenosis in patients at very highor prohibitive surgical risk: acute and late outcomes of the multicenterCanadian experience. J Am Coll Cardiol 2010;55:1080e1090.
21. Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H,Eggebrecht H, Rubino P, Colombo A, Lange R, Schwarz RR, WendlerO. One-year outcomes of cohort 1 in the Edwards SAPIEN AorticBioprosthesis European Outcome (SOURCE) registry: the Europeanregistry of transcatheter aortic valve implantation using the EdwardsSAPIEN valve. Circulation 2011;124:425e433.
22. Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H,Eggebrecht H, Rubino P, Michev I, Lange R, Anderson WN, WendlerO. Thirty-day results of the SAPIEN aortic Bioprosthesis EuropeanOutcome (SOURCE) Registry: A European registry of transcatheteraortic valve implantation using the Edwards SAPIEN valve. Circula-tion 2010;122:62e69.
23. Webb JG, Altwegg L, Boone RH, Cheung A, Ye J, Lichtenstein S, LeeM, Masson JB, Thompson C, Moss R, Carere R, Munt B, NietlispachF, Humphries K. Transcatheter aortic valve implantation: impact onclinical and valve-related outcomes. Circulation 2009;119:3009e3016.
24. Wenaweser P, Pilgrim T, Roth N, Kadner A, Stortecky S, Kalesan B,Meuli F, Büllesfeld L, Khattab AA,Huber C, Eberle B, Erdös G,Meier B,Jüni P, Carrel T, Windecker S. Clinical outcome and predictors foradverse events after transcatheter aortic valve implantation with the use ofdifferent devices and access routes. Am Heart J 2011;161:1114e1124.
25. Zhao Q-M, Lognone T, Ivascau C, Sabatier R, Roule V, Dahdouh Z,Massetti M, Grollier G. Procedural results and 30-day clinical eventsanalysis following Edwards transcatheter aortic valve implantation in48 consecutive patients: initial experience. Chin Med J (Engl)
2012;125:2807e2810.26. Masson J-B, Kovac J, Schuler G, Ye J, Cheung A, Kapadia S, Tuzcu
ME, Kodali S, Leon MB, Webb JG. Transcatheter aortic valve
implantation: review of the nature, management, and avoidance ofprocedural complications. JACC Cardiovasc Interv 2009;2:811e820.
27. Onsea K, Agostoni P, Samim M, Voskuil M, Kluin J, Budde R,Hendrikse J, Ramjankhan F, van Klarenbosch J, Doesburg P, Sies-werda G, Stella P. First-in-man experience with a new embolicdeflection device in transcatheter aortic valve interventions. Euro-
WF, Davidson CJ, Eisenhauer AC, Makkar RR, Bergman GW,Babaliaros V, Bavaria JE, Velazquez OC, Williams MR, Hueter I, XuK, Leon MB; PARTNER Trial Investigators. Vascular complicationsafter transcatheter aortic valve replacement: insights from the PART-NER (Placement of Aortic Transcatheter Valve) trial. J Am Coll Car-
diol 2012;60:1043e1052.29. Berry C, Asgar A, Lamarche Y, Marcheix B, Couture P, Basmadjian A,
Ducharme A, Laborde J-C, Cartier R, Bonan R. Novel therapeutic as-pects of percutaneous aortic valve replacement with the 21F CoreValveRevalving System. Catheter Cardiovasc Interv 2007;70:610e616.
30. Descoutures F, Himbert D, Lepage L, Iung B, Détaint D, Tchetche D,Brochet E, Castier Y, Depoix J-P, Nataf P, Vahanian A. Contemporarysurgical or percutaneous management of severe aortic stenosis in theelderly. Eur Heart J 2008;29:1410e1417.
31. Marcheix B, Lamarche Y, Berry C, Asgar A, Laborde J-C, BasmadjianA, Ducharme A, Denault A, Bonan R, Cartier R. Surgical aspects ofendovascular retrograde implantation of the aortic CoreValve bio-prosthesis in high-risk older patients with severe symptomatic aorticstenosis. J Thorac Cardiovasc Surg 2007;134:1150e1156.
32. Spargias K, Manginas A, Pavlides G, Khoury M, Stavridis G, Rellia P,Smirli A, Thanopoulos A, Balanika M, Polymeros S, Thomopoulou S,Athanassopoulos G, Karatasakis G, Mastorakou R, Lacoumenta S,Michalis A, Alivizatos P, Cokkinos D. Transcatheter aortic valveimplantation: first Greek experience. Hellenic J Cardiol 2008; 49:397e407.
33. Webb JG, Chandavimol M, Thompson CR, Ricci DR, Carere RG,Munt BI, Buller CE, Pasupati S, Lichtenstein S. Percutaneous aorticvalve implantation retrograde from the femoral artery. Circulation
Sinhal A, Carere RG, Munt B, Ricci D, Ye J, Cheung A, LichtensteinSV. Percutaneous transarterial aortic valve replacement in selectedhigh-risk patients with aortic stenosis. Circulation 2007;116:755e763.
35. Walther T, Simon P, Dewey T, Wimmer-Greinecker G, Falk V,Kasimir MT, Doss M, Borger MA, Schuler G, Glogar D, Fehske W,Wolner E, Mohr FW, Mack M. Transapical minimally invasive aorticvalve implantation: multicenter experience. Circulation 2007;116:I240eI245.
36. Ye J, Cheung A, Lichtenstein SV, Altwegg LA, Wong DR, Carere RG,Thompson CR, Moss RR, Munt B, Pasupati S, Boone RH, Masson J-B,Al Ali A, Webb JG. Transapical transcatheter aortic valve implantation:1-year outcome in 26 patients. J Thorac Cardiovasc Surg 2009;137:167e173.
37. Zierer A, Wimmer-Greinecker G, Martens S, Moritz A, Doss M. Thetransapical approach for aortic valve implantation. J Thorac Car-
diovasc Surg 2008;136:948e953.38. Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein
AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel M, Petersen J,Popma JJ, Takkenberg JJM, Vahanian A, van Es G-A, Vranckx P,Webb JG, Windecker S, Serruys PW. Standardized endpoint definitionsfor Transcatheter Aortic Valve Implantation clinical trials: a consensusreport from the Valve Academic Research Consortium. J Am Coll
Cardiol 2011;57:253e269.
1890 The American Journal of Cardiology (www.ajconline.org)
