Transcatheter aortic valve replacement in pure native aortic valve regurgitation
Selected in the Journal of the American College of Cardiology by S. Brugaletta
Yoon SH, Schmidt T, Bleiziffer S, Schofer N, Fiorina C, Munoz-Garcia AJ, Yzeiraj E, Amat-Santos IJ, Tchetche D, Jung C, Fujita B, Mangieri A, Deutsch MA, Ubben T, Deuschl F, Kuwata S, De Biase C, Williams T, Dhoble A, Kim WK, Ferrari E, Barbanti M, Vollema EM, Miceli A, Giannini C, Attizzani GF, Kong WKF, Gutierrez-Ibanes E, Jimenez Diaz VA, Wijeysundera HC, Kaneko H, Chakravarty T, Makar M, Sievert H, Hengstenberg C, Prendergast BD, Vincent F, Abdel-Wahab M, Nombela-Franco L, Silaschi M, Tarantini G, Butter C, Ensminger SM, Hildick-Smith D, Petronio AS, Yin WH, De Marco F, Testa L, Van Mieghem NM, Whisenant BK, Kuck KH, Colombo A, Kar S, Moris C, Delgado V, Maisano F, Nietlispach F, Mack MJ, Schofer J, Schaefer U, Bax JJ, Frerker C, Latib A, Makkar RR
J Am Coll Cardiol. 2017 Dec 5;70(22):2752-2763
LinkRead the abstract
Latest contributionsTranscatheter aortic valve replacement in pure native aortic valve regurgitation Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial Results of the 30-day ABSORB IV, 3-year ABSORB III and 4-year ABSORB II Late Breaking Trials: TCT 2017
Why this study – the rationale/objective?
Pure native aortic regurgitation (AR) has been considered a contraindication for TAVR due to absent aortic valve calcification and the subsequent difficulty in anchoring the transcatheter valves. The initial report of TAVR using the early-generation self-expanding prostheses for pure native AR showed high rates of procedural complications. However, the new-generation devices with retrievability and repositioning capacity, external sealing cuff, or unique anchoring mechanisms could potentially overcome the procedural challenges in treating pure native AR.
The present paper aimed to create an international multicenter registry of TAVR in pure native AR and evaluate the procedural and clinical outcomes of TAVR in patients with pure native AR, taking into consideration the technological developments of transcatheter valves.
How was it executed – the methodology?
From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices.
What is the main result?
- A total of 331 patients underwent TAVR and were included in the study.
- The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively.
- STS score tended to be lower in the new-generation device group (6.2±6.7 vs. 7.6±6.7; p=0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001).
- Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p=0.007) and post-procedural AR≥moderate (4.2% vs. 18.8%; p < 0.001).
- There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p=0.001).
- On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p 1⁄4 0.001).
Critical reading and the relevance for clinical practice
The present study is the largest study evaluating safety, efficacy and clinic outcomes of TAVR in patients with pure native AR. AR is a challenge for TAVR, as calcification, usually used for valve anchoring, is poor.
Although no definite conclusions about the use of this percutaneous technique in AR may be drawn, it is interesting to see that TAVR technological improvements have increased device success rate and reduced complications in this particular subset of patients. After 10 years of TAVR in aortic stenosis, other 10 years or even less will be needed to have this technique available also for aortic regurgitation.
Do you have any experience in treating pure aortic regurgitation with TAVR devices?