Impact of Mild Paravalvular Regurgitation on Long-Term Clinical Outcomes After Transcatheter Aortic Valve Implantation

The impact of mild paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) remains controversial. We evaluated the impact of mild PVR after TAVI on long-term clinical outcomes. We included patients who underwent TAVI for severe symptomatic aortic stenosis between December 2008 and June 2019 at 2 international centers and compared all-cause death between the group with mild PVR (group 1) and the group with none or trace PVR (group 2). PVR was categorized using a 3-class grading scheme, and patients with PVR ≧ moderate and those who were lost to follow-up were excluded. This retrospective analysis included 1,404 patients (mean age 81.7 ± 6.5 years, 58.0% women). Three hundred fifty eight patients (25.5%) were classified into group 1 and 1,046 patients (74.5%) into group 2. At baseline, group 1 was older and had a lower body mass index, worse co-morbidities, and more severe aortic stenosis. To account for these differences, propensity score matching was performed, resulting in 332 matched pairs. Within these matched groups, during a mean follow-up of 3.2 years, group 1 had a significantly lower survival rate at 5 years (group 1: 62.0% vs group 2: 68.0%, log-rank p = 0.029, hazard ratio: 1.41 95% confidence interval: 1.04 to 1.91). In the matched cohort, patients with mild PVR had a significant 1.4-fold increased risk of mortality at 5 years after TAVI compared with those with none or trace PVR. Further studies with more patients are needed to evaluate the impact of longer-term outcomes. The impact of mild paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) remains controversial. We evaluated the impact of mild PVR after TAVI on long-term clinical outcomes. We included patients who underwent TAVI for severe symptomatic aortic stenosis between December 2008 and June 2019 at 2 international centers and compared all-cause death between the group with mild PVR (group 1) and the group with none or trace PVR (group 2). PVR was categorized using a 3-class grading scheme, and patients with PVR ≧ moderate and those who were lost to follow-up were excluded. This retrospective analysis included 1,404 patients (mean age 81.7 ± 6.5 years, 58.0% women). Three hundred fifty eight patients (25.5%) were classified into group 1 and 1,046 patients (74.5%) into group 2. At baseline, group 1 was older and had a lower body mass index, worse co-morbidities, and more severe aortic stenosis. To account for these differences, propensity score matching was performed, resulting in 332 matched pairs. Within these matched groups, during a mean follow-up of 3.2 years, group 1 had a significantly lower survival rate at 5 years (group 1: 62.0% vs group 2: 68.0%, log-rank p = 0.029, hazard ratio: 1.41 95% confidence interval: 1.04 to 1.91). In the matched cohort, patients with mild PVR had a significant 1.4-fold increased risk of mortality at 5 years after TAVI compared with those with none or trace PVR. Further studies with more patients are needed to evaluate the impact of longer-term outcomes. Postoperative paravalvular regurgitation (PVR) is an important complication after transcatheter aortic valve implantation (TAVI) and is associated with increased mortality.1Kodali S Pibarot P Douglas PS Williams M Xu K Thourani V Rihal CS Zajarias A Doshi D Davidson M Tuzcu EM Stewart W Weissman NJ Svensson L Greason K Maniar H Mack M Anwaruddin S Leon MB Hahn RT. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: characterizing patients and impact on outcomes.Eur Heart J. 2015; 36: 449-456Crossref PubMed Scopus (358) Google Scholar,2Popma JJ Adams DH Reardon MJ Yakubov SJ Kleiman NS Heimansohn D Hermiller Jr, J Hughes GC Harrison JK Coselli J Diez J Kafi A Schreiber T Gleason TG Conte J Buchbinder M Deeb GM Carabello B Serruys PW Chenoweth S Oh JK CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery.J Am Coll Cardiol. 2014; 63: 1972-1981Crossref PubMed Scopus (843) Google Scholar The impact of PVR ≧ moderate after TAVI on clinical outcomes has been debated. PVR ≧ moderate occurs in 5% to 25% of patients after TAVI and is associated with a twofold to threefold increased risk of mortality.3Athappan G Patvardhan E Tuzcu EM Svensson LG Lemos PA Fraccaro C Tarantini G Sinning JM Nickenig G Capodanno D Tamburino C Latib A Colombo A Kapadia SR. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature.J Am Coll Cardiol. 2013; 61: 1585-1595Crossref PubMed Scopus (660) Google Scholar, 4Pibarot P Hahn RT Weissman NJ Monaghan MJ. Assessment of paravalvular regurgitation following TAVR: a proposal of unifying grading scheme.JACC Cardiovasc Imaging. 2015; 8: 340-360Crossref PubMed Scopus (219) Google Scholar, 5Pibarot P Hahn RT Weissman NJ Arsenault M Beaudoin J Bernier M Dahou A Khalique OK Asch FM Toubal O Leipsic J Blanke P Zhang F Parvataneni R Alu M Herrmann H Makkar R Mack M Smalling R Leon M Thourani VH Kodali S. Association of paravalvular regurgitation with 1-year outcomes after transcatheter aortic valve replacement with the SAPIEN 3 valve.JAMA Cardiol. 2017; 2: 1208-1216Crossref PubMed Scopus (142) Google Scholar However, at present, PVR ≧ moderate rarely occurs after this procedure along with the improvements in valve design, for example, external sealing skirts and repositionability, and increasing operator experience.6Schoechlin S Hein M Brennemann T Eichenlaub M Schulz U Jander N Neumann FJ. 5-year outcomes after transcatheter aortic valve implantation: focus on paravalvular leakage assessed by echocardiography and hemodynamic parameters.Catheter Cardiovasc Interv. 2022; 99: 1582-1589Crossref PubMed Scopus (11) Google Scholar Although the prevalence of mild PVR ranges from 30% to 41% after TAVI using current generation valves and implantation techniques,7Nazif TM Cahill TJ Daniels D McCabe JM Reisman M Chakravarty T Makkar R Krishnaswamy A Kapadia S Chehab BM Wang J Spies C Rodriguez E Kaneko T Hahn RT Leon MB George I. Real-world experience with the SAPIEN 3 ultra transcatheter heart valve: a propensity-matched analysis from the United States.Circ Cardiovasc Interv. 2021; 14e010543Crossref Scopus (20) Google Scholar, 8Forrest JK Kaple RK Tang GHL Yakubov SJ Nazif TM Williams MR Zhang A Popma JJ Reardon MJ. Three generations of self-expanding transcatheter aortic valves: a report from the STS/ACC TVT registry.JACC Cardiovasc Interv. 2020; 13: PubMed Scopus Google Scholar, A M U M G S M F M L A J MB M R S A D S A A D D F M M Sinning JM J N V D V M R Colombo A A Latib and clinical outcomes of transcatheter aortic valve replacement with the self-expanding 2022; PubMed Scopus Google Scholar is after aortic valve replacement in clinical to P E Dahou A E E Toubal O Bernier M Beaudoin J G J L Thourani VH Makkar R Kodali M Kapadia Leipsic J Blanke P Williams MR McCabe JM V S P A Alu Xu K E Mack MJ Leon MB Hahn RT of transcatheter aortic valve replacement in the PARTNER 3 2020; PubMed Scopus Google L N H P T P PS outcomes in patients with severe aortic valve stenosis to transcatheter aortic valve replacement: the aortic valve clinical Cardiovasc Interv. PubMed Scopus Google Scholar The of TAVI has been to a a for patients with severe aortic stenosis Carabello F H Mack M C VH TM A C for the of Heart A of the of Heart Association on Clinical Am Coll Cardiol. 2021; in J Am Coll in J Am Coll PubMed Scopus Google is important to the long-term of mild PVR in a clinical in the of mild PVR S Pibarot P Douglas PS Williams M Xu K Thourani V Rihal CS Zajarias A Doshi D Davidson M Tuzcu EM Stewart W Weissman NJ Svensson L Greason K Maniar H Mack M Anwaruddin S Leon MB Hahn RT. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: characterizing patients and impact on outcomes.Eur Heart J. 2015; 36: 449-456Crossref PubMed Scopus (358) Google Scholar, JJ Adams DH Reardon MJ Yakubov SJ Kleiman NS Heimansohn D Hermiller Jr, J Hughes GC Harrison JK Coselli J Diez J Kafi A Schreiber T Gleason TG Conte J Buchbinder M Deeb GM Carabello B Serruys PW Chenoweth S Oh JK CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery.J Am Coll Cardiol. 2014; 63: 1972-1981Crossref PubMed Scopus (843) Google Scholar, G Patvardhan E Tuzcu EM Svensson LG Lemos PA Fraccaro C Tarantini G Sinning JM Nickenig G Capodanno D Tamburino C Latib A Colombo A Kapadia SR. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature.J Am Coll Cardiol. 2013; 61: 1585-1595Crossref PubMed Scopus (660) Google E F S A B J H M P M C C P K J A A M E aortic regurgitation in and transcatheter aortic valve replacement analysis of and impact on long-term from the 2014; PubMed Scopus Google R O B P M S N J T U D D D D PA between aortic regurgitation and after 2014; PubMed Scopus Google Scholar and long-term to mild PVR mild PVR is associated with an increased risk of mortality at 5 years after the S Hein M Brennemann T Eichenlaub M Schulz U Jander N Neumann FJ. 5-year outcomes after transcatheter aortic valve implantation: focus on paravalvular leakage assessed by echocardiography and hemodynamic parameters.Catheter Cardiovasc Interv. 2022; 99: 1582-1589Crossref PubMed Scopus (11) Google T D D J F S D S outcomes of mild paravalvular regurgitation after transcatheter aortic valve 2022; PubMed Scopus Google Scholar In this to the of mild PVR after TAVI on 5-year mortality using an international TAVI with a matching The international TAVI and from patients who were and and who underwent TAVI for severe or aortic valves at 2 in and in The for this retrospective analysis patients with severe who underwent TAVI between December 2008 and June with PVR ≧ moderate were from the were those PVR or were and using a report by and The were for and The to the of the of and was by the clinical and was on A heart evaluated patients for for TAVI to the J D L Blanke P A D B Leipsic J R G J K J transcatheter aortic valve replacement clinical and to of Cardiovasc PubMed Scopus Google Scholar the at the TAVI procedure was using a with or at the of the using a self-expanding transcatheter heart valve and and and SAPIEN 3 Edwards or were on the of and were We at baseline, after the procedure and at 1 or 3 and 1 after the assessed PVR to the SJ P N TG Hahn RT Kodali S Mack MJ R J P S Serruys PW Leon for transcatheter aortic valve implantation: the Am Coll Cardiol. 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Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature.J Am Coll Cardiol. 2013; 61: 1585-1595Crossref PubMed Scopus (660) Google Scholar, 4Pibarot P Hahn RT Weissman NJ Monaghan MJ. Assessment of paravalvular regurgitation following TAVR: a proposal of unifying grading scheme.JACC Cardiovasc Imaging. 2015; 8: 340-360Crossref PubMed Scopus (219) Google Scholar, 5Pibarot P Hahn RT Weissman NJ Arsenault M Beaudoin J Bernier M Dahou A Khalique OK Asch FM Toubal O Leipsic J Blanke P Zhang F Parvataneni R Alu M Herrmann H Makkar R Mack M Smalling R Leon M Thourani VH Kodali S. Association of paravalvular regurgitation with 1-year outcomes after transcatheter aortic valve replacement with the SAPIEN 3 valve.JAMA Cardiol. 2017; 2: 1208-1216Crossref PubMed Scopus (142) Google Scholar the impact of mild PVR on are at S Pibarot P Douglas PS Williams M Xu K Thourani V Rihal CS Zajarias A Doshi D Davidson M Tuzcu EM Stewart W Weissman NJ Svensson L Greason K Maniar H Mack M Anwaruddin S Leon MB Hahn RT. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: characterizing patients and impact on outcomes.Eur Heart J. 2015; 36: 449-456Crossref PubMed Scopus (358) Google Scholar, JJ Adams DH Reardon MJ Yakubov SJ Kleiman NS Heimansohn D Hermiller Jr, J Hughes GC Harrison JK Coselli J Diez J Kafi A Schreiber T Gleason TG Conte J Buchbinder M Deeb GM Carabello B Serruys PW Chenoweth S Oh JK CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery.J Am Coll Cardiol. 2014; 63: 1972-1981Crossref PubMed Scopus (843) Google Scholar, G Patvardhan E Tuzcu EM Svensson LG Lemos PA Fraccaro C Tarantini G Sinning JM Nickenig G Capodanno D Tamburino C Latib A Colombo A Kapadia SR. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature.J Am Coll Cardiol. 2013; 61: 1585-1595Crossref PubMed Scopus (660) Google E F S A B J H M P M C C P K J A A M E aortic regurgitation in and transcatheter aortic valve replacement analysis of and impact on long-term from the 2014; PubMed Scopus Google R O B P M S N J T U D D D D PA between aortic regurgitation and after 2014; PubMed Scopus Google Scholar to the of TAVI PVR and at a lower the long-term of mild PVR on outcomes evaluated the of the TAVI procedure has been to patients with risk to the current Carabello F H Mack M C VH TM A C for the of Heart A of the of Heart Association on Clinical Am Coll Cardiol. 2021; in J Am Coll in J Am Coll PubMed Scopus Google T D D J F S D S outcomes of mild paravalvular regurgitation after transcatheter aortic valve 2022; PubMed Scopus Google Scholar studies on the long-term impact of mild PVR been to the the are T D D J F S D S outcomes of mild paravalvular regurgitation after transcatheter aortic valve 2022; PubMed Scopus Google Scholar mild PVR using the 3-class grading and PVR using the grading are associated with an increased risk of 5-year S Hein M Brennemann T Eichenlaub M Schulz U Jander N Neumann FJ. 5-year outcomes after transcatheter aortic valve implantation: focus on paravalvular leakage assessed by echocardiography and hemodynamic parameters.Catheter Cardiovasc Interv. 2022; 99: 1582-1589Crossref PubMed Scopus (11) Google Scholar mild PVR using the 3-class grading is an of In of in the and in the a with self-expanding mild PVR was associated with a 5-year mortality MJ Leon MB Tuzcu EM Douglas PS Kodali Makkar Kapadia S J Hahn RT Thourani VH V A Herrmann Williams M J Davidson MJ Svensson LG PARTNER 1 outcomes of transcatheter aortic valve replacement or aortic valve replacement for risk patients with aortic stenosis a 2015; PubMed Scopus Google TG Reardon MJ Popma JJ Deeb GM Yakubov SJ Kleiman NS S Hermiller Jr, J W P N G Hughes GC Harrison JK Conte M Oh JK J Adams DH CoreValve Clinical outcomes of self-expanding transcatheter aortic valve replacement in Am Coll Cardiol. 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Association of paravalvular regurgitation with 1-year outcomes after transcatheter aortic valve replacement with the SAPIEN 3 valve.JAMA Cardiol. 2017; 2: 1208-1216Crossref PubMed Scopus (142) Google M H B P K J P A M A E T D D D B A G A D F P N A C P J H F R S G P V G A F B E M 2 of transcatheter implantation in J PubMed Scopus Google JK Reardon MJ Kleiman NS G D L B Coselli J K J M Adams DH Popma JJ CoreValve Clinical of paravalvular aortic regurgitation and of self-expanding transcatheter aortic valve: an from the CoreValve Cardiovasc Imaging. 2015; 8: PubMed Scopus Google J A J E M G B R M D S R D R K V K K A D Pibarot P outcomes after transcatheter aortic valve implantation: on and valve from the Am Coll Cardiol. 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