Key result
SAPIEN3 Ultra TAVI links to ~59% less mild or greater PVR versus SAPIEN3.
Why the study?
The optimal percent oversizing with the SAPIEN3 Ultra balancing paravalvular regurgitation against conduction disturbance was unknown compared with the SAPIEN3.
Does transcatheter aortic valve implantation with the SAPIEN3 Ultra compared to the SAPIEN3 reduce paravalvular regurgitation and conduction disturbance at different degrees of percent oversizing in patients with severe aortic stenosis?
Cohort (n=956)
Does transcatheter aortic valve implantation with the SAPIEN3 Ultra compared to the SAPIEN3 reduce paravalvular regurgitation and conduction disturbance at different degrees of percent oversizing in patients with severe aortic stenosis?
Absolute Event Rate: 8.9% vs 21.8%
p-value: p=<0.001
The SAPIEN3 Ultra valve tolerates a lesser degree of percent oversizing (0-5%) to mitigate paravalvular regurgitation compared to the SAPIEN3, optimally balancing the risks of regurgitation and conduction disturbance.
Suggests the newer valve design may allow less oversizing to balance regurgitation and conduction.
The optimal percent oversizing (%OS) using the SAPIEN3 Ultra (S3U) weighing the incidence of paravalvular regurgitation (PVR) ≥ mild against the risk of conduction disturbance (CD) is not known. This study sought to define an optimal extent of the annulus area %OS suitable for transcatheter aortic valve implantation with the S3U compared with the SAPIEN3 (S3). A total of 350 patients with the S3U were compared with 606 patients with the S3. Patients were categorized depending on the degree of %OS. PVR ≥ mild was observed in 8.9% of patients with the S3U and in 21.8% of those with the S3 (p <0.001). The S3U demonstrated a sustainably lower incidence of PVR ≥ mild than the S3 in any extent of %OS. There was an inverse proportional relation between the extent of %OS and frequency of PVR ≥ mild in the S3, whereas the S3U group provided little change. The incidences of PVR ≥ mild were steady >5%OS in the S3 (5% to 10%OS: 13.3%, and >10%OS: 12.1%) and >0%OS in the S3U (0% to 5%OS: 5.9%, 5% to 10%OS: 6.0%, and >10%OS: 6.1%). An increasing %OS was independently associated with the occurrence of CD (<0%OS: 9.8%, 0% to 5%OS: 13.1%, 5% to 10%OS: 16.6%, and >10%OS: 19.2%, p = 0.012). The incidence of PVR ≥ mild and/or CD was the lowest (10.1%) in the 0% to 5%OS in patients with the S3U. In conclusion, the HomoSAPIEN2 study suggests that the S3U tolerates a lesser degree of %OS for mitigating PVR ≥ mild than the S3. Minimal %OS, ranging from 0% to 5%, may be optimal for the S3U with balancing the risk of PVR and CD.Trial Identifier: UMIN000040413/URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046115. The optimal percent oversizing (%OS) using the SAPIEN3 Ultra (S3U) weighing the incidence of paravalvular regurgitation (PVR) ≥ mild against the risk of conduction disturbance (CD) is not known. This study sought to define an optimal extent of the annulus area %OS suitable for transcatheter aortic valve implantation with the S3U compared with the SAPIEN3 (S3). A total of 350 patients with the S3U were compared with 606 patients with the S3. Patients were categorized depending on the degree of %OS. PVR ≥ mild was observed in 8.9% of patients with the S3U and in 21.8% of those with the S3 (p <0.001). The S3U demonstrated a sustainably lower incidence of PVR ≥ mild than the S3 in any extent of %OS. There was an inverse proportional relation between the extent of %OS and frequency of PVR ≥ mild in the S3, whereas the S3U group provided little change. The incidences of PVR ≥ mild were steady >5%OS in the S3 (5% to 10%OS: 13.3%, and >10%OS: 12.1%) and >0%OS in the S3U (0% to 5%OS: 5.9%, 5% to 10%OS: 6.0%, and >10%OS: 6.1%). An increasing %OS was independently associated with the occurrence of CD (<0%OS: 9.8%, 0% to 5%OS: 13.1%, 5% to 10%OS: 16.6%, and >10%OS: 19.2%, p = 0.012). The incidence of PVR ≥ mild and/or CD was the lowest (10.1%) in the 0% to 5%OS in patients with the S3U. In conclusion, the HomoSAPIEN2 study suggests that the S3U tolerates a lesser degree of %OS for mitigating PVR ≥ mild than the S3. Minimal %OS, ranging from 0% to 5%, may be optimal for the S3U with balancing the risk of PVR and CD. Trial Identifier: UMIN000040413/URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046115. Transcatheter aortic valve implantation (TAVI) has become an established treatment for patients with severe aortic stenosis (AS).1Mack MJ Leon MB Thourani VH Makkar R Kodali SK Russo M Kapadia SR Malaisrie SC Cohen DJ Pibarot P Leipsic J Hahn RT Blanke P Williams MR McCabe JM Brown DL Babaliaros V Goldman S Szeto WY Genereux P Pershad A Pocock SJ Alu MC Webb JG Smith CR PARTNER 3 InvestigatorsTranscatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients.N Engl J Med. 2019; 380: 1695-1705Crossref PubMed Scopus (2796) Google Scholar, 2Leon MB Smith CR Mack MJ Makkar RR Svensson LG Kodali SK Thourani VH Tuzcu EM Miller DC Herrmann HC Doshi D Cohen DJ Pichard AD Kapadia S Dewey T Babaliaros V Szeto WY Williams MR Kereiakes D Zajarias A Greason KL Whisenant BK Hodson RW Moses JW Trento A Brown DL Fearon WF Pibarot P Hahn RT Jaber WA Anderson WN Alu MC Webb JG PARTNER 2 Investigators. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients.N Engl J Med. 2016; 374: 1609-1620Crossref PubMed Scopus (0) Google Scholar, 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 (5015) Google Scholar Despite continuous procedural refinements, paravalvular regurgitation (PVR) remains an important limitation for its application to patients with AS with a long life expectancy because PVR occurs more commonly after TAVI than surgical aortic valve replacement, and even mild PVR is associated with increased worse outcomes.4Okuno T Tomii D Heg D Lanz J Praz F Stortecky S Reineke D Windecker S Pilgrim T. Five-year outcomes of mild paravalvular regurgitation after transcatheter aortic valve implantation.EuroIntervention. 2022; 18: 33-42Crossref PubMed Scopus (29) Google Scholar,5Yokoyama H Sugiyama Y Miyashita H Jalanko M Ochiai T Shishido K Yamanaka F Vähäsilta T Saito S Laine M Moriyama N. Impact of mild paravalvular regurgitation on long-term clinical outcomes after transcatheter aortic valve implantation.Am J Cardiol. 2023; 191: 14-22Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar The precedent balloon-expandable valve, SAPIEN3 (S3, Edwards Lifesciences, Irvine, California), reduced the incidence of PVR inversely related to the degree of multidetector computed tomography (MDCT) annulus percent oversizing (%OS).6Yang TH Webb JG Blanke P Dvir D Hansson NC Nørgaard BL Thompson CR Thomas M Wendler O Vahanian A Himbert D Kodali SK Hahn RT Thourani VH Schymik G Precious B Berger A Wood DA Pibarot P Rodés-Cabau J Jaber WA Leon MB Walther T Leipsic J. Incidence and severity of paravalvular aortic regurgitation with multidetector computed tomography nominal area oversizing or undersizing after transcatheter heart valve replacement with the Sapien 3: a comparison with the Sapien XT [published correction appears in JACC Cardiovasc Interv 2015;8:876].JACC Cardiovasc Interv. 2015; 8: 462-471Crossref PubMed Scopus (0) Google Scholar However, in exchange for preventing PVR, a significant degree of %OS with the S3 transcatheter heart valve (THV) increases conduction disturbance (CD), which is linked to worse outcomes.7Chamandi C Barbanti M Munoz-Garcia A Latib A Nombela-Franco L Gutiérrez-Ibanez E Veiga-Fernandez G Cheema AN Cruz-Gonzalez I Serra V Tamburino C Mangieri A Colombo A Jiménez-Quevedo P Elizaga J Lee DH Garcia Del Blanco B Puri R Côté M Philippon F Rodés-Cabau J Long-term outcomes in patients with new-onset persistent left bundle branch block following TAVR.JACC Cardiovasc Interv. 2019; 12: 1175-1184Crossref PubMed Scopus (56) Google Scholar,8Sammour Y Krishnaswamy A Kumar A Puri R Tarakji KG Bazarbashi S B Svensson L O Kapadia and of after transcatheter aortic valve Cardiovasc Interv. PubMed Scopus Google Scholar the SAPIEN3 Ultra with an reduced mild PVR in comparison with the D McCabe JM M T Makkar R Krishnaswamy A Kapadia S Wang J C E T Hahn RT Leon MB with the 3 transcatheter heart a from the Cardiovasc Interv. Scopus Google Scholar, H Miyashita H J M Laine comparison of transcatheter aortic valve replacement with the 3 Ultra versus 3: the Cardiovasc Interv. PubMed Scopus Google Scholar, T C J J M Transcatheter aortic valve replacement with balloon-expandable comparison of 3 versus Cardiovasc Interv. PubMed Scopus Google Scholar the for the S3 has for the is is optimal for the S3U. to the incidence of PVR with area %OS between the and in with the risk of CD and to define an optimal for the S3U A total of patients TAVI from the between in and in were The of the in The for the study were patients with AS TAVI with the S3U and S3. patients with the S3U and and patients with the S3 and were to the and the incidence of CD. 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Transcatheter or surgical aortic-valve replacement in intermediate-risk patients.N Engl J Med. 2016; 374: 1609-1620Crossref PubMed Scopus (0) Google Scholar, p p There were significant the of and degree of In the procedural significant were observed in %OS and implantation p p the incidence of valve implantation and annulus were between 0% of was observed in the and procedural ≥ valve aortic aortic severity area valve or = = multidetector computed = = oversizing = or S3 nominal area area = = = left bundle branch = left = = = S3 = = bundle branch S3U = SAPIEN3 TAVI = transcatheter aortic valve = = transcatheter heart = in a or = = multidetector computed = = oversizing = or S3 nominal area area = = = left bundle branch = left = = = S3 = = bundle branch S3U = SAPIEN3 TAVI = transcatheter aortic valve = = transcatheter heart = was significant in the aortic between the S3U and S3 in the of PVR ≥ mild was lower in patients with the 8.9% p 0% p = p = and p In the risk of PVR ≥ mild on is The S3U implantation a lower risk of PVR ≥ mild than the S3 and to between to to to to to There was significant in the risk of PVR ≥ mild between patients with the S3U and the S3 to lower of PVR ≥ mild were observed with or ≥ annulus for significant and aortic valve in the S3U the of PVR ≥ the extent of %OS. 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PVR after TAVI has an important that is associated with heart and increased S D A A A G and outcomes of with heart after transcatheter aortic valve from the 2022; Scopus Google G E Tuzcu EM Svensson LG C G JM G D Tamburino C Latib A Colombo A Kapadia and outcomes of aortic regurgitation after transcatheter aortic valve and of Cardiol. PubMed Scopus Google Scholar on the long-term of mild PVR PVR is associated with an increased risk of T Tomii D Heg D Lanz J Praz F Stortecky S Reineke D Windecker S Pilgrim T. Five-year outcomes of mild paravalvular regurgitation after transcatheter aortic valve implantation.EuroIntervention. 2022; 18: 33-42Crossref PubMed Scopus (29) Google Scholar,5Yokoyama H Sugiyama Y Miyashita H Jalanko M Ochiai T Shishido K Yamanaka F Vähäsilta T Saito S Laine M Moriyama N. Impact of mild paravalvular regurgitation on long-term clinical outcomes after transcatheter aortic valve implantation.Am J Cardiol. 2023; 191: 14-22Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar In the PARTNER with the to of PVR ≥ mild and to of or severe PVR were MJ Leon MB Thourani VH Makkar R Kodali SK Russo M Kapadia SR Malaisrie SC Cohen DJ Pibarot P Leipsic J Hahn RT Blanke P Williams MR McCabe JM Brown DL Babaliaros V Goldman S Szeto WY Genereux P Pershad A Pocock SJ Alu MC Webb JG Smith CR PARTNER 3 InvestigatorsTranscatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients.N Engl J Med. 2019; 380: 1695-1705Crossref PubMed Scopus (2796) Google MB Smith CR Mack MJ Makkar RR Svensson LG Kodali SK Thourani VH Tuzcu EM Miller DC Herrmann HC Doshi D Cohen DJ Pichard AD Kapadia S Dewey T Babaliaros V Szeto WY Williams MR Kereiakes D Zajarias A Greason KL Whisenant BK Hodson RW Moses JW Trento A Brown DL Fearon WF Pibarot P Hahn RT Jaber WA Anderson WN Alu MC Webb JG PARTNER 2 Investigators. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients.N Engl J Med. 2016; 374: 1609-1620Crossref PubMed Scopus (0) Google Scholar in the clinical of PVR ≥ of or severe PVR, was observed with the O Schymik G H H L G Vahanian 3 and of the of the of the 3 transcatheter heart PubMed Scopus Google Scholar The of the PVR ≥ mild between the and a lower of PVR ≥ mild associated with the to D McCabe JM M T Makkar R Krishnaswamy A Kapadia S Wang J C E T Hahn RT Leon MB with the 3 transcatheter heart a from the Cardiovasc Interv. Scopus Google Scholar, H Miyashita H J M Laine comparison of transcatheter aortic valve replacement with the 3 Ultra versus 3: the Cardiovasc Interv. PubMed Scopus Google Scholar, T C J J M Transcatheter aortic valve replacement with balloon-expandable comparison of 3 versus Cardiovasc Interv. PubMed Scopus Google S C S Barbanti M S G T Nombela-Franco L K T R A P P G E L Tamburino C G F outcomes after transcatheter aortic valve implantation with the balloon-expandable the S3U 2023; 18: Scopus Google Scholar The HomoSAPIEN2 study is with with of PVR, or PVR in mild PVR in and or PVR in of patients TAVI with the associated with significant PVR in patients with the were S I Y Y Makkar RR H Thourani VH Babaliaros V Webb JG A H R K T P S D Herrmann HC Mack MJ M R S M Kapadia SR Krishnaswamy A A SC AS Rodés-Cabau J Leon MB Kodali Impact of aortic and on paravalvular in transcatheter aortic valve replacement with using the Edwards 3 Cardiovasc Interv. PubMed Scopus Google Scholar In compared with the a lower incidence of PVR ≥ mild in patients with or ≥ was observed in the p = and p <0.001). that the of the S3U is in mitigating PVR the of However, is important to that significant increases the risk of PVR, even with the is a risk of aortic TAVI using balloon-expandable valve T M Heg D Lanz J Praz F D C A A L Stortecky S Windecker S Pilgrim T. Impact of left on procedural outcomes after transcatheter aortic valve Cardiovasc Interv. PubMed Scopus Google Scholar be for the significant PVR with procedural In of aortic the of the to be for PVR ≥ mild than the p = The with severe and has the risk of increased incidence of PVR and Miyashita H H Yamanaka F T J Saito S M Laine in aortic stenosis following transcatheter aortic valve implantation.Am J Cardiol. 2022; Full Text Full Text PDF Google A S Babaliaros V H Pilgrim T O S F T C L M M M B A Barbanti M Pershad A B M L Ochiai T T M P F D T S R R McCabe JM Williams MR Whisenant B V Windecker S E L B Mack M JJ Leon MB Makkar RR Transcatheter aortic valve and outcomes after transcatheter aortic valve Cardiol. PubMed Scopus Google Scholar In to the PVR or may in aortic A S Babaliaros V H Pilgrim T O S F T C L M M M B A Barbanti M Pershad A B M L Ochiai T T M P F D T S R R McCabe JM Williams MR Whisenant B V Windecker S E L B Mack M JJ Leon MB Makkar RR Transcatheter aortic valve and outcomes after transcatheter aortic valve Cardiol. PubMed Scopus Google M TH J Tamburino C Wood DA H Blanke P Makkar RR Latib A Colombo A G R G M Kapadia S J G R F M GP M Kodali S BL Hansson NC G SJ H Leon MB Webb JG Leipsic J and procedural associated with aortic balloon-expandable transcatheter aortic valve PubMed Scopus Google Scholar %OS or of be for The CD after TAVI block and new-onset Despite a of the an of worse outcomes with and patients Y Krishnaswamy A Kumar A Puri R Tarakji KG Bazarbashi S B Svensson L O Kapadia and of after transcatheter aortic valve Cardiovasc Interv. PubMed Scopus Google Scholar is associated with a of of C Barbanti M Munoz-Garcia A Latib A Nombela-Franco L Gutiérrez-Ibanez E Veiga-Fernandez G Cheema AN Cruz-Gonzalez I Serra V Tamburino C Mangieri A Colombo A Jiménez-Quevedo P Elizaga J Lee DH Garcia Del Blanco B Puri R Côté M Philippon F Rodés-Cabau J Long-term outcomes in patients with new-onset persistent left bundle branch block following TAVR.JACC Cardiovasc Interv. 2019; 12: 1175-1184Crossref PubMed Scopus (56) Google Scholar the incidence of CD be to the extent The of the the clinical outcomes between the and a of to D McCabe JM M T Makkar R Krishnaswamy A Kapadia S Wang J C E T Hahn RT Leon MB with the 3 transcatheter heart a from the Cardiovasc Interv. Scopus Google Scholar, H Miyashita H J M Laine comparison of transcatheter aortic valve replacement with the 3 Ultra versus 3: the Cardiovasc Interv. PubMed Scopus Google Scholar, T C J J M Transcatheter aortic valve replacement with balloon-expandable comparison of 3 versus Cardiovasc Interv. PubMed Scopus Google S C S Barbanti M S G T Nombela-Franco L K T R A P P G E L Tamburino C G F outcomes after transcatheter aortic valve implantation with the balloon-expandable the S3U 2023; 18: Scopus Google Scholar This study is with to The incidence of CD after TAVI has with of implantation with or the of is a of CD in with implantation H R C M M A K H T E I D R A Williams following transcatheter aortic valve Cardiovasc Interv. 2019; 12: PubMed Scopus Google Scholar In the on and implantation were independently associated with CD. In %OS has a significant with the incidence of with a the %OS, the more CD with for %OS that is be in the heart the risk of CD. In a the with its the the S3 was associated with PVR a lesser degree of TH Webb JG Blanke P Dvir D Hansson NC Nørgaard BL Thompson CR Thomas M Wendler O Vahanian A Himbert D Kodali SK Hahn RT Thourani VH Schymik G Precious B Berger A Wood DA Pibarot P Rodés-Cabau J Jaber WA Leon MB Walther T Leipsic J. Incidence and severity of paravalvular aortic regurgitation with multidetector computed tomography nominal area oversizing or undersizing after transcatheter heart valve replacement with the Sapien 3: a comparison with the Sapien XT [published correction appears in JACC Cardiovasc Interv 2015;8:876].JACC Cardiovasc Interv. 2015; 8: 462-471Crossref PubMed Scopus (0) Google Scholar has established that significant %OS of balloon-expandable valve the risk of significant P Pibarot P Hahn R Kodali S Thourani V R Dvir D C Nørgaard BL P Jaber H Mack M Smith C Leon M Webb J Leipsic J. oversizing and incidence of paravalvular regurgitation of a transcatheter heart Cardiovasc Interv. PubMed Scopus Google Scholar In significant %OS the of increasing the risk of aortic and M M Serra V E Nombela-Franco L R D A E I Côté M H Pibarot P P Philippon F Garcia Blanco B Rodés-Cabau J and long-term clinical of persistent left bundle branch block following transcatheter aortic valve implantation with a balloon-expandable Cardiol. PubMed Scopus Google Scholar In that optimal of is to significant PVR and the risk of However, using the is a or not to a significant degree of oversizing or undersizing to the risk of PVR and CD because an inverse of %OS between the incidence of PVR and CD. In the incidence of PVR after TAVI with the is in extent of %OS and steady the the incidence of CD increases with increasing %OS. the optimal of %OS with the may be between 0% and This %OS may a of the for aortic on patients with annulus and the of a or a remains V Cheema AN M Nombela-Franco L Veiga-Fernandez G V A Del D L Del M Serra V Munoz-Garcia A E Himbert D G JM E F L Y JM J Rodés-Cabau J degree of balloon-expandable transcatheter valve oversizing in patients with aortic annulus from a Cardiovasc Interv. 2023; Scholar that a increased the risk of any on and clinical This study is with the of in patients with annulus may not be in of and CD. However, not on and the of for study is to study has of those with a the outcomes were the was of the and The of be in the of for were not severity on or in may the incidence of PVR and not the the for a or valve was on the of the heart for the in SAPIEN3 Ultra is in SAPIEN3 with a However, not the of the In conclusion, the was associated with a reduced incidence of PVR in comparison with the with to the for the of the with weighing the risk of PVR against that of a degree of %OS, ranging from 0% to 5%, may be the significant PVR and mitigating CD. be in the heart for optimal in patients with AS Moriyama has for from Edwards Lifesciences, and is a clinical of Edwards and and a from the Ochiai has for from Shishido has for from Vähäsilta is a clinical of Edwards Laine from and from Edwards Lifesciences, and Saito is a clinical of Edwards and The to with
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Moriyama et al. (2023) conducted a cohort in Transcatheter aortic valve implantation (n=956). SAPIEN3 Ultra (S3U) vs. SAPIEN3 (S3) was evaluated on Paravalvular regurgitation (PVR) ≥ mild (p=<0.001). Transcatheter aortic valve implantation with the SAPIEN3 Ultra resulted in a lower incidence of paravalvular regurgitation ≥ mild compared to the SAPIEN3 (8.9% vs 21.8%, p<0.001).
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