Redo-Transcatheter Aortic Valve Implantation Using the SAPIEN 3/Ultra Transcatheter Heart Valves—Expert Consensus on Procedural Planning and Techniques

Abstract

Recent guidelines on valvular heart disease in Europe and the United States have expanded the indications for transcatheter aortic valve implantation (TAVI) to younger patients and those at lower surgical risk with severe symptomatic aortic stenosis. Consequently, the number of TAVI procedures will significantly increase worldwide. Patients with longer life expectancies will outlive their transcatheter heart valves (THVs) and require established treatment strategies for re-intervention. Current data have shown encouraging outcomes, including low mortality, with redo-TAVI; in contrast, surgical explantation of THVs is associated with high mortality. Redo-TAVI, therefore, is likely to be the treatment of choice for THV failure. The expected increase in the number of redo-TAVIs stands in contrast to the current lack of evidence on how this procedure should be planned and performed, including the risks and pitfalls operators need to consider. Preliminary reports stress the importance of preprocedural planning, understanding of THV skirt and leaflet characteristics, and implantation guidelines specific to different THVs. Currently, SAPIEN 3/Ultra is the only THV approved in Europe and the United States for redo-TAVI. Therefore, we gathered a panel of experts in TAVI procedures with the aim of providing operative guidance on redo-TAVI, using the SAPIEN 3/Ultra THV. This consensus article presents a step-by-step approach encompassing clinical, anatomical, and technical aspects in preprocedural planning, procedural techniques, and postprocedural care. In conclusion, the recommendations aim to improve the feasibility, safety, and long-term outcomes of redo-TAVI, including the durability of implanted THVs. Recent guidelines on valvular heart disease in Europe and the United States have expanded the indications for transcatheter aortic valve implantation (TAVI) to younger patients and those at lower surgical risk with severe symptomatic aortic stenosis. Consequently, the number of TAVI procedures will significantly increase worldwide. Patients with longer life expectancies will outlive their transcatheter heart valves (THVs) and require established treatment strategies for re-intervention. Current data have shown encouraging outcomes, including low mortality, with redo-TAVI; in contrast, surgical explantation of THVs is associated with high mortality. Redo-TAVI, therefore, is likely to be the treatment of choice for THV failure. The expected increase in the number of redo-TAVIs stands in contrast to the current lack of evidence on how this procedure should be planned and performed, including the risks and pitfalls operators need to consider. Preliminary reports stress the importance of preprocedural planning, understanding of THV skirt and leaflet characteristics, and implantation guidelines specific to different THVs. Currently, SAPIEN 3/Ultra is the only THV approved in Europe and the United States for redo-TAVI. Therefore, we gathered a panel of experts in TAVI procedures with the aim of providing operative guidance on redo-TAVI, using the SAPIEN 3/Ultra THV. This consensus article presents a step-by-step approach encompassing clinical, anatomical, and technical aspects in preprocedural planning, procedural techniques, and postprocedural care. In conclusion, the recommendations aim to improve the feasibility, safety, and long-term outcomes of redo-TAVI, including the durability of implanted THVs. Transcatheter aortic valve (TAV) implantation (TAVI) has become a widely accepted routine therapy for patients with symptomatic severe aortic valve stenosis. It is recommended by European (European Society of Cardiology/European Association for Cardio-Thoracic Surgery) and American (American Heart Association/American Association for Thoracic Surgery) guidelines in the presence of a heart team consensus.1Vahanian A Beyersdorf F Praz F Milojevic M Baldus S Bauersachs J Capodanno D Conradi L De Bonis M De Paulis R Delgado V Freemantle N Gilard M Haugaa KH Jeppsson A Jüni P Pierard L Prendergast BD Sádaba JR Tribouilloy C Wojakowski W ESC/EACTS Scientific Document Group2021 ESC/EACTS Guidelines for the management of valvular heart disease.Eur Heart J. 2022; 43: 561-632Crossref PubMed Scopus (1361) Google Scholar,2Otto CM Nishimura RA Bonow RO Carabello BA Erwin 3rd, JP Gentile F Jneid H Krieger EV Mack M McLeod C O'gara PT Rigolin VH Sundt 3rd, TM Thompson A Toly C. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: A report of the American College of Cardiology/American Heart Association joint committee on clinical practice guidelines.Circulation. 2021; 143: e35-e71PubMed Google Scholar Recent randomized controlled trials have shown the noninferiority of TAVI to surgical aortic valve replacement (SAVR) in patients with low risk,3Smith CR Leon MB Mack MJ Miller DC Moses JW Svensson LG Tuzcu EM Webb JG Fontana GP Makkar RR Williams M Dewey T Kapadia S Babaliaros V Thourani VH Corso P Pichard AD Bavaria JE Herrmann HC Akin JJ Anderson WN Wang D Pocock SJ PARTNER Trial InvestigatorsTranscatheter versus surgical aortic-valve replacement in high-risk patients.N Engl J Med. 2011; 364: 2187-2198Crossref PubMed Scopus (4995) Google Scholar,4Popma JJ Deeb GM Yakubov SJ Mumtaz M Gada H O'Hair D Bajwa T Heiser JC Merhi W Kleiman NS Askew J Sorajja P Rovin J Chetcuti SJ Adams DH Teirstein PS Zorn 3rd, GL Forrest JK Tchétché D Resar J Walton A Piazza N Ramlawi B Robinson N Petrossian G Gleason TG Oh JK Boulware MJ Qiao H Mugglin AS Reardon MJ Evolut Low Risk Trial InvestigatorsTranscatheter aortic-valve replacement with a self-expanding valve in low-risk patients.N Engl J Med. 2019; 380: 1706-1715Crossref PubMed Scopus (2130) Google Scholar accelerating the expansion of TAVI into younger patients with longer life expectancies. All approved transcatheter heart valves (THVs) are based on biologic tissue prone to structural valve degeneration over time. Therefore, younger patients treated by TAVI will present increasingly frequently with bioprosthetic valve failure and the need for re-intervention, including redo-TAVI. However, although TAVI has already proved to be a safe and effective treatment for patients with degenerated surgical bioprostheses (TAV-in-SAV) surgical aortic valve,5Tuzcu EM Kapadia SR Vemulapalli S Carroll JD Holmes DR Jr Mack MJ Thourani VH Grover FL Brennan JM Suri RM Dai D Svensson LG Transcatheter aortic valve replacement of failed surgically implanted bioprostheses: the STS/ACC registry.J Am Coll Cardiol. 2018; 72: 370-382Crossref PubMed Scopus (123) Google Scholar data on the use of TAVI in degenerated TAVI prostheses (redo-TAVI) are still scarce. Early retrospective registries in small numbers of patients have shown no signal for increased procedural risk for redo-TAV compared with TAV-in-SAV.6Landes U Sathananthan J Witberg G De Backer O Sondergaard L Abdel-Wahab M Holzhey D Kim WK Hamm C Buzzatti N Montorfano M Ludwig S Conradi L Seiffert M Guerrero M El Sabbagh A Rodés-Cabau J Guimaraes L Codner P Okuno T Pilgrim T Fiorina C Colombo A Mangieri A Eltchaninoff H Nombela-Franco L Van Wiechen MPH Van Mieghem NM Tchétché D Schoels WH Kullmer M Tamburino C Sinning JM Al-Kassou B Perlman GY Danenberg H Ielasi A Fraccaro C Tarantini G De Marco F Redwood SR Lisko JC Babaliaros VC Laine M Nerla R Castriota F Finkelstein A Loewenstein I Eitan A Jaffe R Ruile P Neumann FJ Piazza N Alosaimi H Sievert H Sievert K Russo M Andreas M Bunc M Latib A Godfrey R Hildick-Smith D Chuang MA Blanke P Leipsic J Wood DA Nazif TM Kodali S Barbanti M Kornowski R Leon MB Webb JG Transcatheter replacement of transcatheter versus surgically implanted aortic valve bioprostheses.J Am Coll Cardiol. 2021; 77: 1-14Crossref PubMed Scopus (43) Google Scholar However, little is known about the best approach to plan and perform redo-TAVI. Procedural planning of redo-TAVI requires careful assessment of specific valve characteristics because all TAVI prostheses have different technical and structural specifications, including mode of deployment (balloon-expandable valve [BEV] vs self-expanding valve [SEV] vs mechanically expanded valve [MEV]), valve function (intra-annular vs supra-annular), and valve and and and the and expansion of the THV in to will the redo-TAVI a approach to redo-TAVI The in procedural planning will be the of of and of This article to consensus on how to plan and perform redo-TAVI in different of TAVI prostheses using the SAPIEN is the only with for this in Europe and the United and are different for re-intervention. A understanding of valve and is for planning of redo-TAVI. of the of approved TAVI are still in routine are no longer technical of the different THV be redo-TAVI is planned and performed, including the and valve and skirt and the and of In the of the THV is for a including to of in to and of and and of valve and of and valve in to of specific THV by the choice of redo-TAVI valve and It is to in the of the THV in specific those in technical therefore, is a of and for all THV The for THV structural valve redo-TAVI valve valve This on redo-TAVI for structural valve to the to the valve and valve because of and leaflet leaflet and P Piazza N Nazif T P JJ Leipsic Blanke P Kapadia S A Mack MJ Makkar R R JJ Reardon M J Van Mieghem NM Webb JG Leon MB for aortic valve clinical Am Coll Cardiol. 2021; 77: PubMed Scopus Google Scholar valve is likely to over and to bioprosthetic valve failure. to THV severe valve is increase in the in with a in effective in compared with assessment to the THV is the mode of a increase of of aortic in severe is for including the of P Piazza N Nazif T P JJ Leipsic Blanke P Kapadia S A Mack MJ Makkar R R JJ Reardon M J Van Mieghem NM Webb JG Leon MB for aortic valve clinical Am Coll Cardiol. 2021; 77: PubMed Scopus Google Scholar heart team on the for redo-TAVI a assessment including and of the in to of the TAVI In the the will guidance on how to plan and perform redo-TAVI using the SAPIEN in a of THV and Transcatheter treatment of a failed THV requires technical procedural risk and long-term outcomes, valve and understanding of specific is planning and redo-TAVI procedures redo-TAVI, the of the failed be by the a The has for the risk of and The of the different THV M S G U Chuang A D Leipsic J Blanke P J A Wood DA JM Webb JG Sathananthan J. and in transcatheter heart for procedures and 2021; PubMed Scopus Google Scholar The effective will to the implantation of the THV. the THV is high to the of the aortic this will in a of a low a THV is in a failed THV with the of the THV be the the THV is implanted This will in leaflet on the valve and The of leaflet be with a of the J R U C Leipsic J Blanke P G D T Wood DA L Webb transcatheter aortic valve implantation and for transcatheter heart valve 2021; PubMed Scopus Google M S U D Gada H T M B R Rovin J Leipsic J Sondergaard L Gleason P K H S Wood DA Webb JG Sathananthan J. valve for treatment of Evolut valve on and leaflet 2022; PubMed Scopus Google Scholar is of a for redo-TAVI in expansion of the failed in the in the of the risk of The of expansion of the THV be preprocedural risk for In of redo-TAVI, the of the THV will be to the The of leaflet THV in a of SAPIEN 3/Ultra implantation in a failed the are and will be a the and the of the THV. 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PubMed Scopus Google Scholar and Mieghem NM M M R U C M C S R P versus of and their on clinical outcomes in patients transcatheter in and of the Heart J. 2018; PubMed Scopus Google Scholar no over therapy TAVI in the of Mieghem NM M M R U C M C S R P versus of and their on clinical outcomes in patients transcatheter in and of the Heart J. 2018; PubMed Scopus Google Backer O H Leipsic Makkar R AS Abdel-Wahab M Kim WK P Van Mieghem N M R Blanke P S L leaflet transcatheter aortic-valve Engl J Med. PubMed Scopus Google Scholar However, a lower of valve in patients treated with Backer O H Leipsic Makkar R AS Abdel-Wahab M Kim WK P Van Mieghem N M R Blanke P S L leaflet transcatheter aortic-valve Engl J Med. 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The current evidence is by procedural into with valve and a for In to retrospective have U Sathananthan J Witberg G De Backer O Sondergaard L Abdel-Wahab M Holzhey D Kim WK Hamm C Buzzatti N Montorfano M Ludwig S Conradi L Seiffert M Guerrero M El Sabbagh A Rodés-Cabau J Guimaraes L Codner P Okuno T Pilgrim T Fiorina C Colombo A Mangieri A Eltchaninoff H Nombela-Franco L Van Wiechen MPH Van Mieghem NM Tchétché D Schoels WH Kullmer M Tamburino C Sinning JM Al-Kassou B Perlman GY Danenberg H Ielasi A Fraccaro C Tarantini G De Marco F Redwood SR Lisko JC Babaliaros VC Laine M Nerla R Castriota F Finkelstein A Loewenstein I Eitan A Jaffe R Ruile P Neumann FJ Piazza N Alosaimi H Sievert H Sievert K Russo M Andreas M Bunc M Latib A Godfrey R Hildick-Smith D Chuang MA Blanke P Leipsic J Wood DA Nazif TM Kodali S Barbanti M Kornowski R Leon MB Webb JG Transcatheter replacement of transcatheter versus surgically implanted aortic valve bioprostheses.J Am Coll Cardiol. 2021; 77: 1-14Crossref PubMed Scopus (43) Google Abdel-Wahab De Backer Sondergaard C. versus the on Kapadia Kodali Mack Leon Thourani of with SAPIEN 3/Ultra on of failed with on Scholar outcomes are in have data on procedural outcomes, with in all and and The reports with a and no different to TAVI to and significantly lower of THV explantation with on U Sathananthan J Witberg G De Backer O Sondergaard L Abdel-Wahab M Holzhey D Kim WK Hamm C Buzzatti N Montorfano M Ludwig S Conradi L Seiffert M Guerrero M El Sabbagh A Rodés-Cabau J Guimaraes L Codner P Okuno T Pilgrim T Fiorina C Colombo A Mangieri A Eltchaninoff H Nombela-Franco L Van Wiechen MPH Van Mieghem NM Tchétché D Schoels WH Kullmer M Tamburino C Sinning JM Al-Kassou B Perlman GY Danenberg H Ielasi A Fraccaro C Tarantini G De Marco F Redwood SR Lisko JC Babaliaros VC Laine M Nerla R Castriota F Finkelstein A Loewenstein I Eitan A Jaffe R Ruile P Neumann FJ Piazza N Alosaimi H Sievert H Sievert K Russo M Andreas M Bunc M Latib A Godfrey R Hildick-Smith D Chuang MA Blanke P Leipsic J Wood DA Nazif TM Kodali S Barbanti M Kornowski R Leon MB Webb JG Transcatheter replacement of transcatheter versus surgically implanted aortic valve bioprostheses.J Am Coll Cardiol. 2021; 77: 1-14Crossref PubMed Scopus (43) Google Scholar Abdel-Wahab De Backer Sondergaard C. versus the on Scholar surgical aortic transcatheter aortic surgical aortic transcatheter aortic Kapadia Kodali Mack Leon Thourani of with SAPIEN 3/Ultra on Scholar TAVI in of failed with on Scholar redo-TAV surgical aortic transcatheter aortic in a reports have encouraging data on the outcomes of redo-TAVI in However, retrospective are and are to have patients with for including and valve on redo-TAVI for structural valve is a need for for data and for on preprocedural procedural and outcomes, and long-term valve has a for a of redo-TAVI with the SAPIEN THV. The will all patients to the heart team for of for bioprosthetic valve of Patients are surgical explantation and and those redo-TAVI with will be in a with data on characteristics, procedural outcomes, and long-term The will patients are redo-TAVI with the SAPIEN 3/Ultra in European TAVI planning and implantation in this will be to the and will be recommended in all The will the and and clinical outcomes of redo-TAVI, by clinical and It to and procedural procedural and clinical will be the for the of using a to for in characteristics and for this is expected to in The consensus is based on a number of and in redo-TAVI no long-term redo-TAVI for should be are in the risks of those with the of the be in THV by be the increased procedural This consensus the best approach to preprocedural and implantation practice in patients redo-TAVI using the SAPIEN THV. registries is to

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