Interventional procedure overview of transcatheter aortic valve implantation for native aortic valve regurgitation
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Appendix B: Other relevant studies
Other potentially relevant studies that were not included in the main evidence summary (tables 2 and 3) are listed in table 5 below. Studies with fewer than 10 patients were excluded.
Study | Number of people and follow up | Direction of conclusions | Reason study was not included in main evidence summary |
|---|---|---|---|
Al Ahmad J, Danson E. (2024) Transcatheter Aortic Valve Implantation for Severe Chronic Aortic Regurgitation. J Clin Med. 13(10):2997. | Review | This review article describes the current evidence for the off-label use of TAVI in pure AR and the various clinical syndromes associated with AR where there may be specific challenges in the application of TAVI. | Review |
Alharbi AA, Khan MZ, Osman M et al. (2020) Transcatheter Aortic Valve Replacement vs Surgical Replacement in Patients With Pure Aortic Insufficiency. Mayo Clin Proc.95 (12):2655-2664. | Propensity matched retrospective cohort study (NIS database) Patients with pure AI. TAVI, n=915 versus SAVR, n=1390 TAVI used as an off-label procedure in some cases. | There was no evidence of a significant statistical difference in in-hospital mortality between patients with pure AI treated by either SAVR or TAVR, both in unmatched and propensity-matched cohorts. TAVR could be considered for patients with pure AI who are not candidates for surgery. | Study already included in systematic review added to summary of evidence. |
Adam M, Tamm AR, Wienemann H et al. (2023) Transcatheter Aortic Valve Replacement for Isolated Aortic Regurgitation Using a New Self-Expanding TAVR System. JACC Cardiovasc Interv. 16(16):1965-1973. | Case series (German registry) N= 58 patients for isolated severe and symptomatic AR underwent TAVR with the JenaValve Trilogy system (new generation). Follow-up 30 days. | Treatment of patients with severe symptomatic AR using the transfemoral JV system is safe and effective. This system may offer a new treatment option for patients with AR not suitable for surgery. | Larger studies with longer follow-up included in the summary of evidence. |
Anwaruddin S, Desai ND, Szeto WY et al. (2019) Self-Expanding Valve System for Treatment of Native Aortic Regurgitation by Transcatheter Aortic Valve Implantation (from the STS/ACC TVT Registry). Am J Cardiol.124(5):781-788. | Retrospective case series N=230 patients in the TVT Registry underwent transfemoral TAVI for primary severe native AR with early generation self- expanding valves (n = 81, CoreValve; n = 149, Evolut R). Follow-up 30 days. | Despite higher 30-day all-cause mortality, self-expanding TAVI may be an option in selected patients with AR who have no surgical options. | Study already included in systematic review added to summary of evidence. |
Baumbach A, Patel KP, Kennon S et al. (2023) A heart valve dedicated for aortic regurgitation: Review of technology and early clinical experience with the transfemoral Trilogy system. Catheter Cardiovasc Interv.102 (4):766-771. | Review and case series of 12 patients with severe AR had TAVI with JenaValve Trilogy. | Expert review on the technical aspects of the Trilogy system, provides a guide for implantation, discuss the available evidence for the technology and provide illustrative case examples. | Large studies with longer follow-up were included in the summary of evidence. |
Belkin MN, Imamura T, Fujino T et al. (2020) Transcatheter Aortic Valve Replacement in Left Ventricular Assist Device Patients with Aortic Regurgitation STRUCTURAL HEART, 4, 2, 107–112 | Retrospective analysis N=7 LVAD patients underwent nine TAVR procedures. Median follow-up of 9 months. | Two patients died of paravalvular complications following device deployment. Procedural success was achieved in 67% of attempts, with significant improvement in RF from 44.8% pre-procedurally to 28.1% at six-month follow-up. Qualitatively moderate paravalvular leak was noted. There was significant improvement in right ventricular function at 6-month follow-up. | More comprehensive studies included in the summary of evidence. |
Bob-Manuel T, Kadire S, Heckle MR et al. (2018) Outcomes following transcatheter aortic valve replacement in patients with native aortic valve regurgitation. Ann Transl Med. 6(1):8, 1-9. | Systematic review 30 studies describing 182 patients were identified. | TAVR is associated with favourable pacemaker implantation and 1-year mortality rates with a high 30-day mortality among selected patients with NAVR. | More recent comprehensive studies included in summary of evidence. |
Costanzo P, Bamborough P, Peterson M (2022) Transcatheter Aortic Valve Implantation for Severe Pure Aortic Regurgitation With Dedicated Devices. Interv Cardiol. 17:e11. | Review | TAVI for patients with pure severe AR and at surgical risk is occasionally performed with two dedicated transcatheter valves (J-Valve and JenaValve). Both devices have been used successfully via the transapical approach. The transfemoral experience is limited. | Review |
Chen S, Zheng F, Li M, Hou S et al. (2022) A study on correlation between preprocedural CT indexes and procedural success rate of transfemoral transcatheter aortic valve replacement with different self-expanding valves (VitaFlow or VenusA-Valve) in patients with pure native aortic regurgitation. Ann Transl Med. 10(11):643 | Retrospective comparative study N=77 symptomatic patients with severe pure native AR (STS score 7.7), who had TF TAVI using a VenusA-Valve (n=47) or a VitaFlow valve (n=30). 2 kinds of self-expanding valves with different shaped frameworks were compared. | Patients with severe pure native AR with a smaller aortic annulus (AA), left ventricular outflow tract (LVOT), sinotubular junction (STJ), and leaflet thickening might have a higher success rate in TF TAVI using a self-expanding valve. The self-expanding valve with a non-A-shaped framework might be a better choice for improved procedural outcomes. | Larger studies included in the summary of evidence. |
De Backer O, Pilgrim T, Simonato M, Mackensen GB et al. (2018) Usefulness of transcatheter aortic valve implantation for treatment of pure native aortic valve regurgitation. Am J Cardiol, 122:1028-1035. | Retrospective case series N=254 patients with pure NAVR had transapical, transfemoral TAVI (devices: Evolut, ACURATE, Portico, SAPIEN 3, Lotus, Direct Flow, JenaValve, Engager) N=109 old generation devices 145 new generation devices. | TAVI is a feasible treatment in high-risk patients with NAVR but is associated with a considerable risk of valve malpositioning and residual AR. | Study already included in systematic review added to summary of evidence. |
De Backer O, Pilgrim T, Sondergaard L et al. (2017) TCT-448 Transcatheter aortic valve replacement for isolated severe native aortic valve regurgitation—Results from the TAVR-NAVR registry. J Am Coll Cardiol 70: B184. | Retrospective case series N= 187 patients had transapical, transfemoral TAVI for severe native AR. 69 had early generation devices (65 CoreValve, 4 Sapien/XT) and 118 had new generation devices (33 JenaValve, 23 Evolut R, 18 Direct Flow, 15 Symetis, 10 Lotus, 9 Engager, 7 Sapien 3, 3 Portico). Follow-up 1 year | TAVR for pure native aortic valve regurgitation is challenging and associated with high rates of post-procedural aortic regurgitation and a need for a second device in addition to high mortality. New generation devices had better clinical outcomes than early generation implants. | Study already included in systematic review added to summary of evidence. |
Delhomme C, M. Urena-Alcazar, O. Zouaghi et al. (2024) Transcatheter aortic valve implantation using the SAPIEN 3 valve to treat aortic regurgitation: The French multicentre S3AR study. Archives of Cardiovascular Diseases. 117, 1, 93-105. | Retrospective and prospective multicentre observational study. N=37 patients with symptomatic, severe, pure AR on native, non-calcified valves, contraindicated to, or at high-risk for surgical valve replacement. TAVI using the balloon-expandable SAPIEN 3 THV. | TAVI using SAPIEN 3 THV seems technically feasible in carefully selected, high-risk patients with pure AR on native and non-calcified valves, who are contraindicated for surgery. It remains an off-label and compassionate use with no mention in current international guidelines. | Larger studies included in the summary of evidence. |
Deng Md, Wei X, Zhang Xl et al. (2019) Changes in left ventricular function in patients with aortic regurgitation 12 months after transapical transcatheter aortic valve implantation. Int J Cardiovasc Imaging 35, 99–105. | Case series n=30 patients with AR had transapical TAVI Follow-up 12 months. | Our results indicate that LV function was improved in terms of myocardial deformation but worsened in terms of apical rotation 12 months after TAVI in patients with AR. | Larger studies included in the summary of evidence. |
El-Gamel A. (2021) Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation: Challenging Pathology Awaiting Specialized Devices. Aorta (Stamford). 9(2):56-59. | Review | Currently, off-label indication for TAVR in pure native AR could be a feasible and reasonable option, as a compassionate treatment is limited to inoperable patients and agreed on by the heart team. | Review |
Franzone A, Piccolo R, Siontis GCM et al. (2016) Transcatheter Aortic Valve Replacement for the Treatment of Pure Native Aortic Valve Regurgitation: A Systematic Review. JACC Cardiovasc Interv.28; 9(22):2308-2317. | Systematic review N=13 studies including 237 patients | Among selected patients with native pure AR deemed at high risk for SAVR, TAVR is technically feasible and associated with an acceptable risk of early mortality. | More recent comprehensive studies included in summary of evidence. |
Gera P, Wasserstein DH, Frishman WH et al (2024) Transcatheter Aortic Valve Implantation for Aortic Regurgitation: A Comprehensive Review. Cardiol Rev. | Review | This article synthesizes current knowledge on AR management, emphasizing advancements in transcatheter aortic valve implantation (TAVI). | Review |
Garcia S, Ye J, Webb J, Reardon M, Kleiman N et al. (2023) Transcatheter Treatment of Native Aortic Valve Regurgitation: The North American Experience With a Novel Device. JACC Cardiovasc Interv. 16(16):1953-1960. | Case series N=27 patients at high surgical risk, with native valve AR had TAVI with the J-Valve. Follow-up 30 days. | The J-Valve provides a safe and effective alternative to surgery in patients with pure AR and elevated or prohibitive surgical risk. | More recent comprehensive studies included in summary of evidence. |
Haddad A, Arwani R, Altayar O, Sawas T, Murad MH, de Marchena E. Transcatheter aortic valve replacement in patients with pure native aortic valve regurgitation: A systematic review and meta-analysis. Clin Cardiol. 2019 Jan;42(1):159-166. | Systematic review and meta-analysis. N=638 patients across 12 studies were included. | AVR appears to be a feasible treatment choice for NAVR patients at high risk for surgical valve replacement. Second generation valves show promising results in terms of short‐term outcomes. | More recent comprehensive studies included in summary of evidence. |
Hinkov H, Lee CB, Pitts L et al. (2024) Transcatheter management of pure native aortic valve regurgitation in patients with left ventricular assist device. Eur J Cardiothorac Surg. 65(3), ezae028 | Retrospective analysis of TAVI for AR in patients with LVAD. N=27 | TAVI yields promising procedural outcomes and early survival rates in LVAD patients with AR. Tailored TAVI devices and pre-stenting techniques enhance procedural success. Continued research into these strategies is essential. | |
Huded CP, Allen KB, Chhatriwalla AK. (2021) Counterpoint: challenges and limitations of transcatheter aortic valve implantation for aortic regurgitation. Heart. 107(24):1942-1945. | Review | Reviews the challenges, evidence and future directions of TAVI for isolated AR. There are no RCTs or mid-term data. Observational studies have shown that outcomes of TAVI for AR are worse than outcomes of TAVI for AS. Two emerging valves have shown promise for AR and data are limited. | Review |
Isogai T, Saad AM, Ahuja KR et al. (2021) Short-term outcomes of transcatheter aortic valve replacement for pure native aortic regurgitation in the United States. Catheter Cardiovasc Interv. 97(3):477-485 | Retrospective database analysis TAVR for pure AR and TAVR for AS. pure AR (n = 1,222, 1.50%), pure AS (n = 72,690, 89.1%), and AS + AR (n = 7,630, 9.36%). the severity of valve disease, and calcification of aortic valve leaflets and annulus), and details of TAVR procedures not reported. In-hospital and 30-day outcomes reported. | TAVR for pure AR was significantly associated with a higher risk of acute kidney injury, cardiac tamponade and prolonged hospital stay compared with TAVR for pure AS, whereas it was not significantly associated with in-hospital mortality and other outcomes. | More recent comprehensive studies included in summary of evidence. |
Koliastasis L, Doundoulakis I, Kokkinidis DG, et al. (2022) TAVI with the ACURATE neo transcatheter heart valve in special populations: A systematic review. Hellenic J Cardiol. 66:67-71. | Systematic Review TAVI with ACURATE neo in special populations (in bicuspid aortic valve, in patients with small aortic annulus, pure aortic regurgitation and valve-in-valve procedures) | ACURATE neo valve may be a feasible and safe option for patients with bicuspid anatomy, small aortic annulus, previously implanted bioprosthetic aortic valve and pure aortic regurgitation. | More recent comprehensive studies included in summary of evidence. |
Koch R, Inci E, Grubb K et al. (2023) A comparison of thirty-day clinical and echocardiographic outcomes of patients undergoing transcatheter vs. surgical aortic valve replacement for native aortic insufficiency. Cardiovasc Revasc Med; 46:85–9. | Comparative cohort study (retrospective) 125 high risk patients with native AI 91 receiving SAVR and 34 receiving TAVR (CoreValve, Evolut R, and Evolut Pro)- femoral and caval route Follow-up 30 days. | Patients who received TAVR had a significantly higher STS predictive risk of mortality (STS-PROM) score than those in the SAVR group (3.96% versus 1.25%). However, the in-hospital mortality and 30-day outcomes (including mortality, stroke, myocardial infarction, residual AR, or repeat valve intervention) did not differ between groups. The results indicated a significantly higher rate of complete heart block requiring PPI in the TAVR group (20.9% versus 2.2%). | Similar comparative study included in the summary of evidence. |
Kong M, Hong Z, Liu X et al. (2022) 30-day outcomes after surgical or transapical aortic valve replacement in symptomatic aortic regurgitation. J Cardiovasc Dev Dis; 9:9, 224, 1-10. | Comparative study (retrospective) N=69 transapical TAVI with J valve versus n=42 SAVR in patients with symptomatic AR. Follow-up 30 days. | The TA-TAVR approach is safe and reliable, with similar clinical efficacy to SAVR, and has advantages in bleeding rate and speed of recovery. | Study already included in systematic review added to summary of evidence. |
Kirtchuk D, Williams T, Cockburn J et al. (2020) Transcatheter Aortic Valve Implantation in Patients With Symptomatic Severe Aortic Regurgitation Using the Self-Expanding Acurate neo Valve. Cardiovasc Revasc Med. 21(11S):14-17. | Case series N=4 patients with isolated AR treated using the Acurate Neo valve. | Three of the patients had significant symptomatic improvement, one had limited symptomatic improvement despite resolution of her AR on aortogram post TAVI. | Large studies included in the summary of evidence. |
Jiang J, Liu X, He Y et al. (2018) Transcatheter Aortic Valve Replacement for Pure Native Aortic Valve Regurgitation: A Systematic Review. Cardiology. 141(3):132-140. | Systematic Review N= 10 studies on TAVR in 266 patients with pure NAVR were included. | Aortic regurgitation remains a challenging pathology for TAVR. TAVR is a feasible and reasonable option for carefully selected patients with pure aortic regurgitation. | More recent comprehensive studies included in summary of evidence. |
Liu R, Fu Z and Yao J et al. (2023) Transcatheter Aortic Valve Replacement for Aortic Regurgitation – A Review. CVIA. 8(1). | Review | This review examines current evidence and clinical practice, and presents technological advancements in devices for AR. | Review |
Liu H, Yang Y, Wang W et al (2018). Transapical transcatheter aortic valve replacement for aortic regurgitation with a second-generation heart valve. J Thorac Cardiovasc Surg. 156:106-116. | Case series (prospective) ChiCTR-OPC-15006354 N=43 patients with high-risk severe pure native AR had transapical TAVI with the J-Valve. | This multicentre study shows that the J-Valve transcatheter heart valve system is a reasonable option for patients with predominant AR. | Study already included in systematic review added to summary of evidence. |
Liu L, Zhang J, Peng Y et al. (2020) Learning curve for transcatheter aortic valve replacement for native aortic regurgitation: Safety and technical performance study. Clin Cardiol. 43(5):475-482. | Retrospective case series (reviewed a prospective database) N=134 patients with pure native AR who had TAVI with the J-valve. Patients were divided as early (group 1: first 52 cases) and skilled (group 2: the next 82 cases). | For a surgeon without previous TAVR experience, 52 cases of performance is the minimal requirement to gain the proficiency of TAVR for native AR. The skilled surgeons have been observed with reduced procedural time, fluoroscopy times, radiation exposure dose, and contrast volume usage. However, the overall prognosis was not significantly different between the two groups. | More comprehensive studies included in the summary of evidence. |
Liu H, Liu S, Lu Y, et al. (2020) Transapical transcatheter aortic valve implantation for predominant aortic regurgitation with a self-expandable valve. J Thorac Dis. 12 (3):538-549. | Case series N=47 patients with predominant AR had transapical TAVI with J-Valve. Follow-up 4 years. | This study revealed that, transapical TAVI with J-Valve for treating AR has encouraging mid-term outcomes, and the advantages at one year demonstrated in previous study can be maintained through 4 years. | Study already included in systematic review added to summary of evidence. |
Liu L, Chen S, Shi J et al. (2020) Transcatheter Aortic Valve Replacement in Aortic Regurgitation. Ann Thorac Surg. 110 (6):1959-1965. | Case series N=134 patients with severe AR and high surgical risk had transapical TAVI with the JValve Follow-up 6 months. | Transcatheter aortic valve replacement with the J-Valve proved to have acceptable early and midterm clinical outcomes for patients with aortic regurgitation. | Study already included in systematic review added to summary of evidence. |
Liu L, Peng Y, Shi J, et al. (2022) Initial experience with repositionable J-Valve for severe aortic regurgitation: A single-center experience. J Cardiovasc Surg (Torino); 63:521-528 | Case series N= 290 (161 patients had severe AR and 129 patients had severe AS) had transapical TAVI with JValve. | Prognosis of patients with AR is comparable to that of patients with AS after TAVI with J-valve. Pace- maker rate in the AR group was higher, but structural valve deterioration was more common in AS patients. | Study already included in systematic review added to summary of evidence. |
Liu L, Yao X, Peng Y, et al. (2022) One-year outcome after transcatheter aortic valve replacement for aortic regurgitation: A single-center study. J Card Surg; 37:882-892 | Case series N=134 high-risk patients with pure, symptomatic severe AR had TA TAVI Follow-up 1 year. | In high-risk patients undergoing transapical-TAVR for AR, the use of the J-Valve is safe and effective TAVR should be considered as a reasonable option for high-risk patients with pure AR. | Study already included in systematic review added to summary of evidence. |
Li F, Wang X, Wang Y et al. (2020) Structural Valve Deterioration after Transcatheter Aortic Valve Implantation Using J-Valve: A Long-Term Follow-Up. Ann Thorac Cardiovasc Surg. 26(3):158-165. | Prospective case series N=4 patients with AS and 4 patients with pure AR who had TAVI using Jvalve. 4-year follow-up. | The limited number of cases provides a preliminary indication of the long-term efficacy of TAVI using J-Valve in patients with PAR. None of the hemodynamic SVD occurred in patients with PAR. In patients with AS, although the higher rate of SVD was observed, the overall transcatheter heart valve (THV) hemodynamic remained stable over time after prosthetic valve implantation and the long-term durability of J-Valve was convincing. | More comprehensive studies included in the summary of evidence. |
Lu Y, Yang Y, Liu H et al. (2022) Short-Term Outcomes After Transcatheter Aortic Valve Replacement in Predominant Aortic Regurgitation with Left Ventricular Dysfunction. Int Heart J.63(1):30-35. | Case series N= 27 symptomatic patients with AR and ejection fraction < 50% underwent TAVI using the J-Valve™ system. Follow-up median 369 days. | TAVI using the J-Valve™ system is a reasonable alternative for patients with AR and left ventricular dysfunction regarding promising short-term outcomes. | More comprehensive studies included in the evidence summary. |
Luo X, Wang X, Li X et al. (2017) Transapical transcatheter aortic valve implantation using the J-Valve system: A 1-year follow-up study. J Thorac Cardiovasc Surg.154 (1):46-55. | Case series N= 21 patients with AS (n=17) or AR (n=4) at high risk for open surgery received transapical TAVI using the J-Valve system. Follow-up 1 year. | Study showed excellent performance regarding echocardiographic parameters, improvement in NYHA class after a 12-month follow-up. | More comprehensive studies included in the evidence summary. |
Mentias A, Saad M, Menon V et al. (2023) Transcatheter vs Surgical Aortic Valve Replacement in Pure Native Aortic Regurgitation. Ann Thorac Surg. 115(4):870-876 | Propensity matched retrospective cohort study N= 11,027 patients with pure AR underwent elective AVR (TAVR, n = 1147; SAVR, n = 9880). Median follow-up of 31 months | In Medicare patients with pure native AR, TAVR with the current commercially available transcatheter valves has comparable short-term outcomes. Although long-term outcomes were inferior to SAVR, the possibility of residual confounding, biasing long-term outcomes, given older and frailer TAVR patients, cannot be excluded | Study already included in systematic review added to summary of evidence. |
Narayan P. Native aortic valve regurgitation: TAVR's place in the PANTHEON. Indian J Thorac Cardiovasc Surg. 2023 Nov;39(6):643-645. | Appraisal of the PANTHEON study. TAVI in patients with severe pure native aortic valve regurgitation. | The major complications included valve embolization or migration in 12.4%, moderate to severe AR in 9.5% cases and need for PPM in 22.3% cases. Self-expanding and balloon-expandable devices demonstrated similar outcomes. Those experiencing valve embolization or migration had higher 1-year adverse event rates. | More comprehensive study included in the summary of evidence. |
Noble S, Mauler-Wittwer S. (2024) TAVR as an Alternative to SAVR for Pure Native Aortic Regurgitation. Can J Cardiol. 40 (2): 316-325. | Review | The first-generation transcatheter valves were associated with a higher mortality rate and lower procedural success. Early studies with the dedicated devices showed safety and promising results and will serve a growing number of patients with native AR at risk for surgery. | Review |
Orzalkiewicz M, Foroni M, Chietera F, Bendandi F et al. (2024) Off-Label Use of Balloon-Expandable Transcatheter Valves to Treat Pure Aortic Regurgitation. Am J Cardiol. 222:20-22. | Case series N=13 tricuspid aortic valve patients who underwent transfemoral TAVIs for pure AR with Sapien ballon expandable valve. | TAVI in pure AR with oversized Sapien BEV showed good procedural and short-term outcomes when ≥20% oversizing was predictably achievable. | Large studies included in the summary of evidence. |
Oettinger V, Hilgendorf I, Wolf D et al. (2023) Treatment of pure aortic regurgitation using surgical or transcatheter aortic valve replacement between 2018 and 2020 in Germany. Front Cardiovasc Med.10:1091983. | Retrospective cohort study database analysis N=4,861 procedures-4,025 SAVR and 836 TAVR-for AR TA TAVI, N=50 TF TAVI, N=329 balloon expandable valves TF TAVI, n=457, self-expanding valves. In hospital outcomes reported. | TAVR is a viable alternative to SAVR in the treatment of pure aortic regurgitation for selected patients, showing overall low in-hospital mortality and complication rates, especially with regard to self-expanding transfemoral TAVR. | Study already included in systematic review added to summary of evidence.. |
Pesarini G, Lunardi M, Piccoli A et al. (2018) Effectiveness and Safety of Transcatheter Aortic Valve Implantation in Patients With Pure Aortic Regurgitation and Advanced Heart Failure. Am J Cardiol. 121(5):642-648. | Case series N= 13 inoperable patients with non-calcific, pure AR, and advanced heart failure treated with transfemoral TAVI- self-expandable CoreValves. Follow-up 30 days. | Implanting self-expandable transcatheter valves in patients pure AR in this small study was safe and effective, and represented an important option for inoperable patients with non-calcific severe AR. | Larger studies included in the summary of evidence. |
Phan K, Haswell JM, Xu J et al. (2017) Percutaneous Transcatheter Interventions for Aortic Insufficiency in Continuous-Flow Left Ventricular Assist Device Patients: A Systematic Review and Meta-Analysis. ASAIO J. 63 (2):117-122. | Systematic review and meta-analysis N= 5 published studies and 3 unpublished studies. (n=29 patients) TAVI for AR in LVAD patients. | In the TAVR cohort, two patients experienced device migration and another had significant postimplant perivalvular leakage. Our results indicate that percutaneous interventions for AI in CF-LVAD patients with TAVR, and closure devices demonstrate similar efficacy in significantly reducing severe AI. | More comprehensive studies included in the summary of evidence. |
Poletti E, Adam M, Wienemann H et al. (2024) Performance of Purpose-Built vs Off-Label Transcatheter Devices for Aortic Regurgitation: The PURPOSE Study. JACC Cardiovasc Interv. 17(13):1597-1606. | Retrospective multicentre registry N=256 inoperable patients with severe AR of the native valve had TAVI with off-label devices in 168 cases (66%), and J valve was used in 88 cases (34%). Follow-up 1 year. | The J valve has a better acute performance than other THVs when used off-label for inoperable patients with severe AR. A longer follow-up is needed to detect a possible impact on prognosis. | Similar comparative study already included in the summary of evidence |
Purita PAM, Tahoces LS, Fraccaro C et al. (2020) Transcatheter treatment of native aortic valve regurgitation: Results from an international registry using the transfemoral ACURATE neo valve. Int J Cardiol Heart Vasc. 27:100480. | Case series N= 24 patients with severe NAVR had TAVI with self-expandable ACURATE neo valve. Follow-up 30 days. | This multicentre study suggests good feasibility and early safety of transfemoral TAVI with the self-expandable ACURATE neo device in patients with severe NAVR refused for surgery. Rates of moderate PVL, new pacemaker implantation and need for a second valve were higher than those reported for TAVI in AS. | Study already included in systematic review added to summary of evidence. |
Rali AS, Taduru SS, Tran LE et al. (2022) Transcatheter Aortic Valve Replacement and Surgical Aortic Valve Replacement Outcomes in Left Ventricular Assist Device Patients with Aortic Insufficiency. Card Fail Rev. 8: e30. | Retrospective cohort study (NIS database) N=155 patients with pre-existing continuous-flow LVAD undergoing TAVR (105) or SAVR (50) for AI/pure AR. | In this nationally representative cohort of LVAD patients with post-implant AI, it was observed that TAVR was associated with a lower risk of adverse short-term outcomes compared with SAVR. | Study already included in systematic review added to summary of evidence. |
Roy DA, Schaefer U, Guetta V, et al. Transcatheter aortic valve implantation for pure severe native aortic valve regurgitation. J Am Coll Cardiol. 2013;61(15):1577-1584. | Case series (registry-retrospective and prospective) N=43 patients with pure severe NAVR underwent TAVI with the CoreValve (early generation device). Follow-up 12 months. | This registry analysis demonstrates the feasibility and potential procedure difficulties when using TAVI for severe NAVR. Acceptable results may be achieved in carefully selected patients who are deemed too high risk for conventional surgery. | Study already included in systematic review added to summary of evidence. |
Sanchez-Luna JP, Martín P, Dager AE et al. (2023) Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation. EuroIntervention. 19(7):580-588. | Retrospective cohort study N=113 patients with non-calcified AR (STS 2.7±1.7%) had TAVI with Myval valve. Follow-up 1 year. | Myval is a feasible and safe option for selected non-operable patients with NCAR and demonstrated good midterm outcomes and lack of impact of oversizing on device durability. | Larger studies included in the evidence summary. |
Santos-Martínez S, Amat-Santos IJ. (2021) New Challenging Scenarios in Transcatheter Aortic Valve Implantation: Valve-in-valve, Bicuspid and Native Aortic Regurgitation. Eur Cardiol. 2021 Aug 26;16: e29. | Review | This review aims to discuss the current evidence available supporting the use of TAVI for VIV, bicuspid and Native AR. Evidence for TAVI in pure AR is still anecdotal because of suboptimal outcomes. | Review |
Sawaya FJ, Deutsch MA, Seiffert M et al. (2017) Safety and efficacy of transcatheter aortic valve replacement in the treatment of pure aortic regurgitation in native valves and failing surgical bioprostheses: Results from an international registry study. JACC Cardiovasc Interv, 10:1048-1056 | Case series (retrospective and prospective) N=78 patients with pure NAVR, 68 patients in the failing SHV group. (Evolut R, JenaValve, Direct Flow, Lotus, SAPIEN 3). | AVR for pure NAVR remains a challenging condition, with old-generation THVs being associated with THV embolization and migration and significant paravalvular regurgitation. Newer generation THVs show more promising outcomes. For those patients with severe AR due to failing SHVs, TAVR is a valuable therapeutic option. | Study already included in systematic review added to summary of evidence. |
Schofer J, Nietlispach F, Bijuklic K et al. (2015) Implantation of a Fully Repositionable and Retrievable Transcatheter Valve for Noncalcified Pure Aortic Regurgitation. JACC Cardiovasc Interv. 8 (14):1842-9. | Case series (retrospective) N=11 patients with severe non-calcific pure AR with transfemoral implantation of a TAVI with DirectFlow valve (new generation). 30-day follow-up. | This study reports the feasibility of treating severe non-calcific AR with the Direct Flow prosthesis via the transfemoral route. | Study already included in systematic review added to summary of evidence. |
Schlingloff F, Schäfer U, Frerker C et al. (2014) Transcatheter aortic valve implantation of a second-generation valve for pure aortic regurgitation: procedural outcome, haemodynamic data and follow-up. Interact Cardiovasc Thorac Surg.19 (3):388-93. | Case series N=10 transapical TAVI implantations with JenaValve for pure AR. Follow-up 12 months. | Intraprocedural success and haemodynamic data were good. The mortality rate highlighted the importance of careful patient selection. This device proved to be suitable for treatment of AR in surgical high-risk patients. | Study already included in systematic review added to summary of evidence. |
Seiffert M, Bader R, Kappert U et al. (2014) Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation. JACC Cardiovasc Interv. 7 (10):1168-74. | Case series (retrospective) N=31 patients had transapical TAVI with JenaValve for severe pure native AR. Follow-up 6 months. | This study revealed this is a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection. | Study already included in systematic review added to summary of evidence. |
Shi J, Wei L, Chen Y et al. (2021) Transcatheter aortic valve implantation with J-Valve: 2-year outcomes from a multicenter study. Ann Thorac Surg; 111:1530-1536. | Case series N=107 patients with AR (n=44) or AS (n=63) had transapical TAVI with Jvalve Follow-up 2 years. | This study demonstrated good midterm outcomes of TAVI with the J-Valve system in the treatment of patients with either AS or AI. It suggests that the J-Valve system is a promising alternative therapy in high-risk patients | Study already included in systematic review added to summary of evidence. |
Silaschi M, Conradi L, Wendler O et al. (2018) The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation. Catheter Cardiovasc Interv. 91(7):1345-1351. | Case series (JUPITER) Registry N= 30 patients with pure native AR Follow-up 1 year. | Rate of THV embolization, residual AR and permanent pacemaker implantation was low. One-year results using the JenaValve for AR encourage its use for this indication. | Study already included in systematic review added to summary of evidence. |
Siddique, S., Vora, A., & Gada, H. (2020). Transcatheter Approaches to Aortic Insufficiency. Structural Heart, 5(1), 55–64. | Review | Long-term follow-up of patients with severe AR has demonstrated excess morbidity and mortality, necessitating consideration of early surgical or transcatheter treatment in high-risk patients. | Review |
Spina R, Anthony C, Muller DW et al. (2015) Transcatheter Aortic Valve Replacement for Native Aortic Valve Regurgitation. Interv Cardiol. 10(1):49-54. | Review | Reviews the clinical context, technical characteristics and outcomes associated with transcatheter treatment of native AR. | Review |
Soong EL, Ong YJ, Ho JSY et al. (2021) Transcatheter aortic valve replacement for aortic regurgitation in Asians: TAVR for aortic regurgitation in Asians. Asia Intervention. 7(2):103-111. | Systematic review N=5 studies (n=274 patients with pure native AR undergoing TAVI) and 8 case reports were included. | TAVR has demonstrated acceptable safety and efficacy in Asian patients with pure AR displaying low mortality rates and few adverse outcomes. | More recent comprehensive studies included in summary of evidence. |
Stachon P, Kaier K, Heidt T et al. (2020) Nationwide outcomes of aortic valve replacement for pure aortic regurgitation in Germany 2008–2015. Catheter Cardiovasc Interv. 95:810–6. | Comparative cohort study (retrospective) SAVR versus TAVI in patients with pure AR. SAVR, n=10,528 TF TAVI, n=476 TA TAVI, n= 248. | TAVR is off label used in AR in clinical practice. TAVR seems to be a safe option for AR with regard to in-hospital outcomes. However, further research evaluating long-term outcomes is required to establish the feasibility of TAVR in pure AR. | Study already included in systematic review added to summary of evidence.. |
Testa L, Latib A, Rossi ML, et al. CoreValve implantation for severe aortic regurgitation: a multicentre registry. EuroIntervention. 2014; 10(6):739-745. | Case series (prospective) N=26 inoperable patients undergoing CoreValve TAVR for severe pure native AR compared to patients treated for severe native AS, n=1531. Follow-up 12 months. | TAVR for AR is associated with a significantly higher mortality compared to TAVR for AS. Considering the ominous prognosis of these patients when treated medically, TAVR may be a reasonable choice in selected patients. | Study already included in systematic review added to summary of evidence. |
Toggweiler S, Cerillo AG, Kim WK et al. (2018) Transfemoral Implantation of the Acurate neo for the Treatment of Aortic Regurgitation. J Invasive Cardiol. 30 (9): 329-333. | Case series n= 20 patients with pure native AR undergoing transfemoral TAVR with the Acurate neo prosthesis. Follow up 30 days. | Transfemoral TAVR using the Acurate neo transcatheter heart valve was successful in treating aortic regurgitation, significantly reduced left ventricular dimensions, and improved clinical symptoms. | Large studies included in the summary of evidence. |
Tung M, Wang X, Li F et al. (2018) A versatile transapical device for aortic valvular disease: One-year outcomes of a multicenter study on the J-Valve system. J Cardiol. 72(5):377-384. | Case series N=107 high-risk patients with severe AS (n = 64) or AR (n = 43) had TA TAVI with J valve. Follow-up 1 year. | Study provides further evidence on the safety and efficacy of the J-Valve in high-risk patients with AS or AR for surgery. | Similar study included in systematic review added to summary of evidence. |
Wang Y, Yu S, Qian D, et al. (2022) Anatomic predictor of severe prosthesis malposition following transcatheter aortic valve replacement with self- expandable Venus-A Valve among pure aortic regurgitation: A multicenter retrospective study. Front Cardiovasc Med. 9:1002071. | Retrospective multicentre cohort study. N=62 patients with native AR who underwent TAVI with Venus-A Valve. Outcomes were compared between non-/mild malposition (n=42) and severe malposition groups (n=19). | Larger and higher sinotubular junction (STJ), as well as greater STJ to valve crown diameter ratio, may help identify patients at high risk for severe prosthesis malposition among patients with native AR undergoing TAVI. | Larger studies included in the summary of evidence. |
Wernly B, Eder S, Navarese EP et al. (2019) Transcatheter aortic valve replacement for pure aortic valve regurgitation: "on-label" versus "off-label" use of TAVR devices. Clin Res Cardiol.108 (8):921-930. | Review N=12 studies (640 patients) 208 (33%) patients with pure AR were treated with "on-label" devices: JenaValve and J valve). | observational data TAVR for pure AR shows that it is feasible and safe in patients deemed inoperable. First-generation TAVR devices are associated with inferior outcome and should be avoided. The use of "on-label" devices is associated with a significantly higher procedural success rate and might be favourable compared to other second-generation devices. | More comprehensive studies included in the summary of evidence. |
Vahl T, Makkar R, Kodali S, Baldus S, Treede H, Daniels D, et al. 30-day outcomes of transfemoral transcatheter aortic valve replacement for aortic regurgitation with a novel self-expanding prosthesis. J Am Coll Cardiol 2021;77: 919. | ALIGN-AR trial (NCT 04415047) Prospective study N=71 patients with primary symptomatic AR at high surgical risk had transfemoral TAVI with the JenaValve. Follow-up 30 days. | This study has reported technical feasibility and promising short-term clinical and hemodynamic outcomes. | Study already included in systematic review added to summary of evidence. |
Xue Y, Zhou Q, Li S et al. (2021) Transapical Transcatheter Valve Replacement Using J-Valve for Aortic Valve Diseases. Ann Thorac Surg. 112(4):1243-1249. | Case series N=23 patients had TAVI using the J-Valve system. 10 had AS, 11 had AR, 2 had VIV. | TAVI with the J-Valve system is effective, even when it is traumatic and requires the transapical route. | Larger studies included in the summary of evidence. |
Yang L, Chen S, Zhang X et al. (2024) Comparisons of noncoronary sinus pivot implantation (NCPI) and conventional method for transcatheter aortic valve replacement with self-expanding valve in pure aortic regurgitation (PAR). Catheter Cardiovasc Interv.103(7):1093-1100. | Retrospective case series (NTCVR registry analysis). N=55 patients with pure AR had TF TAVI with self-expanding valves (VitaFlow and Venus A valve). Sub-groups: Group A had noncoronary sinus pivot implantation (NCPI method, n=16). Group B had conventional method (n=39) | TAVR with a self‐expanding valve using the NCPI method had a higher procedure success rate and dramatically low complications than that using the conventional method (valve was implanted below both the noncoronary sinus and left coronary sinus) in patients with pure AR. | Larger studies included in the summary of evidence. |
Yin WH, Lee YT, Tsao TP et al. (2022) Outcomes of transcatheter aortic valve replacement for pure native aortic regurgitation with the use of newer- vs. early-generation devices. Ann Transl Med.10 (1):24 | Comparative study (retrospective analysis) N=25 TAVI was done with early- (N=15, CoreValve, Lotus and Sapien XT) and newer-generation (N=10, Evolut R in 7 and J valve in 3) valves in patients with pure native AR at an intermediate-to-high risk for SAVR. Median follow-up of 14 months | Early-generation TAVR devices are associated with less satisfactory outcomes in the treatment of patients with pure native AR and should be avoided. TAVR using newer generation THVs has yielded better procedural outcomes and can be a great asset to treat certain patients. Dedicated TAVR devices for pure native AR are preferred to other newer generation devices. | Larger studies included in the summary of evidence. |
Yousef A, MacDonald Z, Simard T et al. (2018) Transcatheter Aortic Valve Implantation (TAVI) for Native Aortic Valve Regurgitation - A Systematic Review. Circ J. 82(3):895-902. | Systematic review 175 patients were included from 31 studies. | TAVI demonstrates acceptable safety and efficacy in high-risk patients with severe NAVR. Second-generation valves may afford a similar safety profile with improved device success. Dedicated studies are needed to definitively establish the efficacy of TAVI in this population. | More recent comprehensive studies included in summary of evidence. |
Yoon SH, Schmidt T, Bleiziffer S et al (2017). Transcatheter aortic valve replacement in pure native aortic valve regurgitation. J Am Coll Cardiol; 70:2752-2763. | Registry analysis (retrospective and prospective). N=331 patients with pure NAVR underwent TAVI (transfemoral, transapical). The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%). (SAPIEN 3, Evolut R, JenaValve, Direct Flow, JValve, Engager, Portico, ACURATE, Lotus). Follow-up 1 year. | Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality. | Study already included in systematic review added to summary of evidence. |
Zheng HJ, Cheng YB, Yan CJ, et al. (2023) Transfemoral transcatheter aortic valve replacement for pure native aortic regurgitation: one-year outcomes of a single center study. BMC Cardiovasc Disord. 23:330. | Retrospective study N=45 patients with pure native AR had transfemoral Venus A-valve implantation. Follow- up 1 year. | Study reported a 97.8% success rate with 1 patient requiring conversion to SAVR. They observed a significant increase in LVEF from 42% at baseline to 62% at 1-year. In-hospital mortality rate and 1-year mortality rate were 2.3% and 4.7%, respectively. They concluded that further study is needed to assess the long-term durability of the Venus A-valve | Larger study included in the summary of evidence. |
Zhu D, Chen Y, Guo Y, et al. (2015) Transapical transcatheter aortic valve implantation using a new second-generation TAVI system - J-Valve for high-risk patients with aortic valve diseases: Initial results with 90-day follow-up. Int J Cardiol.199:155-162 | Case series N= 20 patients with isolated aortic valve disease (11 with pure/dominant AR and 9 with AS) at high risk for SAVR had TAVI with J valve. Follow-up 3 months. | Trans-apical TAVI using the J-Valve™ prosthesis is potentially an effective treatment option for patients with AS or pure/dominant AR at high risk for open-heart surgery. | Study already included in systematic review added to summary of evidence. |
Zhu D, Wei L, Cheung A et al. (2016) Treatment of pure aortic regurgitation using a second-generation transcatheter aortic valve implantation system. J Am Coll Cardiol; 67:2803–5. | Case series N=33 patients with pure native AR and high surgical risk had TA TAVI with J valve. | Our results demonstrated that this new valve could become a potentially feasible treatment option in patients with AR who are at high risk for SAVR. | Study already included in systematic review added to summary of evidence. |
Zhu L, Guo Y, Wang W et al. (2018) Transapical transcatheter aortic valve replacement with a novel transcatheter aortic valve replacement system in high-risk patients with severe aortic valve diseases. J Thorac Cardiovasc Surg. 155(2):588-597. | Case series N= 107 high-risk patients (had TAVI with the J-Valve (63 patients with AS and 44 patients with pure native AR). Follow-up 6 months. | TAVI by the J-Valve is an adequate clinical option to treat high-risk patients with severe aortic stenosis or aortic regurgitation. | Study already included in systematic review added to summary of evidence. |
Zhu D, Chen Y, Zhang J et al. (2015) Transapical implantation of a new second-generation transcatheter heart valve in patients with pure aortic regurgitation: a preliminary report. Interact CardioVasc Thorac Surg; 20:860–2 | Case series N=7 high-risk patients with pure native AR treated with a TAVI using the J-Valve™ system. | Patients were successfully treated with the TAVI procedure. | Larger studies were included in the summary of evidence. |
Zhou C, Xia Z, Song Y, Lian Z. (2023) Transcatheter versus surgical aortic valve replacement in patients with aortic regurgitation: a propensity-matched analysis. Heliyon. 9(6): e16734. | Propensity score matched retrospective cohort study N=3640 patients with AR TAVI 1820 versus SAVR 1820 Follow-up 6 months | TAVR and SAVR had similar risks of hospital death and lower rates of 30-day and 6-month all-cause and cardiovascular readmission. But TAVR had a higher risk of permanent pacemaker implantation than SAVR in patients with AR, suggesting that TAVR can be performed safely in patients with pure AR. | Study already included in systematic review added to summary of evidence. |
Zhang, X., Liang, C., Zha, L. et al. (2024) Predictors for new-onset conduction block in patients with pure native aortic regurgitation after transcatheter aortic valve replacement with a new-generation self-expanding valve (VitaFlow Liberty™): a retrospective cohort study. BMC Cardiovasc Disord 24, 77. | Retrospective cohort study N=68 patients with pure native AR who had TAVI using new-generation self-expanding valves (VitaFlow Liberty™). 20 patients had PPM implanted after TAVI. | Multivariate logistic regression analysis revealed an association between the need for postoperative PPI and preoperative complete right bundle branch block (cRBBB) or first-degree atrioventricular block (AVB), as well as a non-tubular left ventricular outflow tract (LVOT). | More comprehensive studies included in the summary of evidence. |
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