© 2015 Wiley Periodicals, Inc.
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ACQUIRED CARDIOVASCULAR DISEASE ORIGINAL ARTICLE _____________________________________________________________
Transaortic TAVI Is a Valid Alternative to Transapical Approach Katie E. O’ Sullivan, M.D., M.R.C.S.,* Eoghan T. Hurley,* Ricardo Segurado, Ph.D.,y Declan Sugrue, M.D., F.R.C.P.,* and John P. Hurley, M.D., F.R.C.P.* *The Heart Team, Mater Private Hospital, Dublin, Ireland; and y CSTAR Centre for Statistical Training and Research, University College Dublin, Ireland ABSTRACT Background and Aim: Transcatheter aortic valve implantation (TAVI) can be performed via a number of different anatomical approaches based on patient characteristics and operator choice. The aim of this study was to compare procedural outcomes between transaortic (TAo) and transapical (TA) approaches in an effort to establish whether any differences exist. Methods: A systematic review and meta-analysis of the current literature reporting outcomes for patients undergoing TAo and TA TAVI was performed to compare outcomes using each vascular approach to valve deployment. Results: A total of 10 studies and 1736 patients were included. A total of 193 patients underwent TAo and 1543 TA TAVI. No significant difference in 30-day mortality was identified (TAo 9.4, TA 10.4 p = 0.7). There were no significant differences identified between TAo and TA TAVI in procedural success rate (96.3% vs. 93.7% p = 0.3), stroke and transient ischemic attack (TIA) incidence (1.8% vs. 2.3% p = 0.7), major bleed (5.8% vs. 5.5% p = 0.97) or pacemaker insertion rates (6.1% vs. 7.4% p = 0.56). In addition, the incidence of clinically significant paravalvular regurgitation (PVR) was the same between groups (6.7% vs. 11% p = 0.43). Conclusion: Comparison of TAo and TA approaches revealed equivalent outcomes in 30-day mortality, procedural success, major bleeding, stroke/TIA incidence, pacemaker insertion rates and paravalvular leak. Heart teams should be familiar with the use of both TA and TAo access and tailor their selection on a case-to-case basis. doi: 10.1111/jocs.12527 (J Card Surg
2015;30:381–390) Worldwide experience with TAVI has expanded in recent years as have the options regarding vascular access. Beyond transapical (TA) and transfemoral (TF), many groups are now describing the use of subclavian/ axillary, carotid, brachiocephalic, and transaortic (TAo) access.1,2 Since its inception most centers have adopted a ‘‘transfemoral first’’ approach and this is accepted by many as the route of choice as it is less invasive.3 While some guidelines recommend this strategy, the quality of evidence to support it is low and neither the NICE guidelines or the 2012 ACCF/ AATS/SCAI/STS expert consensus document recommends a specific route.4,5 TF remains the most commonly utilized access point reported in both Europe and the US and accounts for approximately 70% of TAVI cases performed to date.6–9 There are a number of factors which preclude a TF approach: severe iliofemoral atherosclerosis; insufficient luminal caliber or severe tortuosity of the femoral arteries; collectively termed ‘‘hostile’’ anatomy incapable of accommodating a TF delivery sheath.5 The
Address for correspondence: K.E. O’ Sullivan, M.D., M.R.C.S., Mater Private Hospital, Eccles St., Dublin 7, Ireland. Fax: þ353-1-8858541; e-mail: [email protected]
original TAVI series used the transapical (TA) approach as a second line option in such patients; however, it has been associated with myocardial damage, bleeding, post-procedural chest pain, and pleural effusions. Therefore, the transaortic (TAo) option has recently been explored and described by some authors as a valid alternative to the TA approach.8,10 There is, however, a lack of evidence comparing the two. We sought to perform a systematic review and meta-analysis of procedural outcomes associated with both TA and TAo TAVI in an effort to establish any differences in patient outcome. MATERIALS AND METHODS Study selection This review was conducted in accordance with the Prisma guidelines.11 PubMed was searched by entering the following in the searching algorithm: TAVI and transaortic or TAVI and transapical or TAVR and transaortic or TAVR and transapical or PAVI and transaortic or PAVI and transapical. No language restriction was set. All searches were performed on the 23rd of October 2013. Studies between 2012 and 2013 were included in the search. This was specifically
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O’ SULLIVAN ET AL. TRANSAORTIC VERSUS TRANSAPICAL TAVI
selected to match the time point at which transaortic TAVI was first reported in the literature. Studies reporting the use of transapical TAVI were therefore selected from the same timeframe in an effort to reduce potential biases associated with choosing procedural outcomes at different points in the TAVI learning curve. Two authors (K.E. O’ Sullivan and E.T. Hurley) independently examined the title and abstract of citations, the full texts of potentially eligible trials were obtained, and disagreements were resolved by discussion. Inclusion criteria Studies were included if the following criteria applied: 1) reported data that examined procedural and mortality outcomes from patients undergoing TA or TAo TAVI; 2) enrollment for TAVI was based on existing and accepted guidelines; 3) study design, country, endpoint and year of publication was clearly stated. We included TAVIs performed using the following device types: Medtronic CoreValve (Medtronic CV Luxembourg S.a.r.l., Tolochenaz, Switzerland), and Cribier-Edwards, Edwards Sapien, Sapien XT (Edwards Lifesciences, Santa Ana, CA, USA).
J CARD SURG 2015;30:381–390
resulting in a compartment syndrome or bleeding resulting in hypovolemic shock or severe hypotension. Minor bleeding such as an access site hematoma was not included in this analysis. Pacemaker implantation was defined as any patient with a conduction disturbance warranting implantation of a permanent pacemaker as a result of the valvular implant. Paravalvular regurgitation Clinically significant paravalvular regurgitation for the purposes of this study was considered as moderate or severe or greater or equal to 2/4þ regurgitation on echocardiographic examination. Procedural success Procedural success was determined as absence of procedural mortality, correct positioning of a single prosthetic heart valve into the correct anatomical position, and intended performance of the prosthetic heart valve (absence of patient-prosthesis mismatch and mean aortic gradient
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ACQUIRED CARDIOVASCULAR DISEASE ORIGINAL ARTICLE _____________________________________________________________
Transaortic TAVI Is a Valid Alternative to Transapical Approach Katie E. O’ Sullivan, M.D., M.R.C.S.,* Eoghan T. Hurley,* Ricardo Segurado, Ph.D.,y Declan Sugrue, M.D., F.R.C.P.,* and John P. Hurley, M.D., F.R.C.P.* *The Heart Team, Mater Private Hospital, Dublin, Ireland; and y CSTAR Centre for Statistical Training and Research, University College Dublin, Ireland ABSTRACT Background and Aim: Transcatheter aortic valve implantation (TAVI) can be performed via a number of different anatomical approaches based on patient characteristics and operator choice. The aim of this study was to compare procedural outcomes between transaortic (TAo) and transapical (TA) approaches in an effort to establish whether any differences exist. Methods: A systematic review and meta-analysis of the current literature reporting outcomes for patients undergoing TAo and TA TAVI was performed to compare outcomes using each vascular approach to valve deployment. Results: A total of 10 studies and 1736 patients were included. A total of 193 patients underwent TAo and 1543 TA TAVI. No significant difference in 30-day mortality was identified (TAo 9.4, TA 10.4 p = 0.7). There were no significant differences identified between TAo and TA TAVI in procedural success rate (96.3% vs. 93.7% p = 0.3), stroke and transient ischemic attack (TIA) incidence (1.8% vs. 2.3% p = 0.7), major bleed (5.8% vs. 5.5% p = 0.97) or pacemaker insertion rates (6.1% vs. 7.4% p = 0.56). In addition, the incidence of clinically significant paravalvular regurgitation (PVR) was the same between groups (6.7% vs. 11% p = 0.43). Conclusion: Comparison of TAo and TA approaches revealed equivalent outcomes in 30-day mortality, procedural success, major bleeding, stroke/TIA incidence, pacemaker insertion rates and paravalvular leak. Heart teams should be familiar with the use of both TA and TAo access and tailor their selection on a case-to-case basis. doi: 10.1111/jocs.12527 (J Card Surg
2015;30:381–390) Worldwide experience with TAVI has expanded in recent years as have the options regarding vascular access. Beyond transapical (TA) and transfemoral (TF), many groups are now describing the use of subclavian/ axillary, carotid, brachiocephalic, and transaortic (TAo) access.1,2 Since its inception most centers have adopted a ‘‘transfemoral first’’ approach and this is accepted by many as the route of choice as it is less invasive.3 While some guidelines recommend this strategy, the quality of evidence to support it is low and neither the NICE guidelines or the 2012 ACCF/ AATS/SCAI/STS expert consensus document recommends a specific route.4,5 TF remains the most commonly utilized access point reported in both Europe and the US and accounts for approximately 70% of TAVI cases performed to date.6–9 There are a number of factors which preclude a TF approach: severe iliofemoral atherosclerosis; insufficient luminal caliber or severe tortuosity of the femoral arteries; collectively termed ‘‘hostile’’ anatomy incapable of accommodating a TF delivery sheath.5 The
Address for correspondence: K.E. O’ Sullivan, M.D., M.R.C.S., Mater Private Hospital, Eccles St., Dublin 7, Ireland. Fax: þ353-1-8858541; e-mail: [email protected]
original TAVI series used the transapical (TA) approach as a second line option in such patients; however, it has been associated with myocardial damage, bleeding, post-procedural chest pain, and pleural effusions. Therefore, the transaortic (TAo) option has recently been explored and described by some authors as a valid alternative to the TA approach.8,10 There is, however, a lack of evidence comparing the two. We sought to perform a systematic review and meta-analysis of procedural outcomes associated with both TA and TAo TAVI in an effort to establish any differences in patient outcome. MATERIALS AND METHODS Study selection This review was conducted in accordance with the Prisma guidelines.11 PubMed was searched by entering the following in the searching algorithm: TAVI and transaortic or TAVI and transapical or TAVR and transaortic or TAVR and transapical or PAVI and transaortic or PAVI and transapical. No language restriction was set. All searches were performed on the 23rd of October 2013. Studies between 2012 and 2013 were included in the search. This was specifically
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O’ SULLIVAN ET AL. TRANSAORTIC VERSUS TRANSAPICAL TAVI
selected to match the time point at which transaortic TAVI was first reported in the literature. Studies reporting the use of transapical TAVI were therefore selected from the same timeframe in an effort to reduce potential biases associated with choosing procedural outcomes at different points in the TAVI learning curve. Two authors (K.E. O’ Sullivan and E.T. Hurley) independently examined the title and abstract of citations, the full texts of potentially eligible trials were obtained, and disagreements were resolved by discussion. Inclusion criteria Studies were included if the following criteria applied: 1) reported data that examined procedural and mortality outcomes from patients undergoing TA or TAo TAVI; 2) enrollment for TAVI was based on existing and accepted guidelines; 3) study design, country, endpoint and year of publication was clearly stated. We included TAVIs performed using the following device types: Medtronic CoreValve (Medtronic CV Luxembourg S.a.r.l., Tolochenaz, Switzerland), and Cribier-Edwards, Edwards Sapien, Sapien XT (Edwards Lifesciences, Santa Ana, CA, USA).
J CARD SURG 2015;30:381–390
resulting in a compartment syndrome or bleeding resulting in hypovolemic shock or severe hypotension. Minor bleeding such as an access site hematoma was not included in this analysis. Pacemaker implantation was defined as any patient with a conduction disturbance warranting implantation of a permanent pacemaker as a result of the valvular implant. Paravalvular regurgitation Clinically significant paravalvular regurgitation for the purposes of this study was considered as moderate or severe or greater or equal to 2/4þ regurgitation on echocardiographic examination. Procedural success Procedural success was determined as absence of procedural mortality, correct positioning of a single prosthetic heart valve into the correct anatomical position, and intended performance of the prosthetic heart valve (absence of patient-prosthesis mismatch and mean aortic gradient
