Transcatheter Aortic Valve Implantation for Pure Severe Native Aortic Valve Regurgitation

Roy, David; Schäefer, Ulrich; Guetta, Victor; Hildick‐Smith, David; Möllmann, Helge; Dumonteil, Nicholas; Modine, Thomas; Bosmans, Johan; Petronio, Anna Sonia; Moat, Neil; Linke, Axel; Morís, César; Champagnac, Didier; Parma, Radosław; Ochała, Andrzej; Medvedofsky, Diego; Patterson, Tiffany; Woitek, Felix; Jahangiri, Marjan; Laborde, Jean‐Claude; Brecker, Stephen

doi:10.1016/j.jacc.2013.01.018

Cited by 261 publications

(181 citation statements)

References 31 publications

Supporting

Mentioning

153

Contrasting

Unclassified

Order By: Relevance

“…Earlier studies also studied TAVI beyond the context of calcific AS, in pure aortic regurgitation patients (65,66), bicuspid aortic valve and (as in a number of our included studies) valve-in-valve for both redo-TAVI or SAVR (6,25,32,67,68).…”

Section: Tavi Trials Expanding Indications and Criticismsmentioning

confidence: 99%

Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond

Chakos

Wilson-Smith

Arora

et al. 2017

Ann. Cardiothorac. Surg.

View full text Add to dashboard Cite

Background: Transcatheter aortic valve implantation/replacement (TAVI/TAVR) is becoming more frequently used to treat aortic stenosis (AS), with increasing push for the procedure in lower risk patients.Numerous randomized controlled trials have demonstrated that TAVI offers a suitable alternative to the current gold standard of surgical aortic valve replacement (SAVR) in terms of short-term outcomes. The present review evaluates long-term outcomes following TAVI procedures.Methods: Literature search using three electronic databases was performed up to June 2017. Studies which included 20 or more patients undergoing TAVI procedures, either as a stand-alone or concomitant procedure and with a follow-up of at least 5 years, were included in the present review. Literature search and data extraction were performed by two independent researchers. Digitized survival data were extracted from Kaplan-Meier curves in order to re-create the original patient data using an iterative algorithm and subsequently aggregated for analysis.Results: Thirty-one studies were included in the present analysis, with a total of 13,857 patients. Two studies were national registries, eight were multi-institutional collaborations and the remainder were institutional series. Overall, 45.7% of patients were male, with mean age of 81.5±7.0 years. Where reported, the mean Logistic EuroSCORE (LES) was 22.1±13.7 and the mean Society of Thoracic Surgeons (STS) score was 9.2±6.6. The pooled analysis found 30-day mortality, cerebrovascular accidents, acute kidney injury (AKI) and requirement for permanent pacemaker (PPM) implantation to be 8.4%, 2.8%, 14.4%, and 13.4%, respectively. Aggregated survival at 1-, 2-, 3-, 5-and 7-year were 83%, 75%, 65%, 48% and 28%, respectively. Conclusions:The present systematic review identified acceptable long-term survival results for TAVI procedures in an elderly population. Extended follow-up is required to assess long-term outcomes following TAVI, particularly before its application is extended into wider population groups. Ann Cardiothorac Surg 2017;6(5):432-443 www.annalscts.com IntroductionAs Western populations age, the prevalence of aortic stenosis (AS) is gradually increasing (1). In a select population, surgical aortic valve replacement (SAVR) is precluded by patient frailty and other comorbidities (2). The availability of transcatheter aortic valve implantation/ replacement (TAVI/TAVR), pioneered in the early 2000s, has made a significant impact on survival for these patients (3-5). These early successes led to a number of trials, such as the PARTNER and US Pivotal trials, which compared TAVI, SAVR and standard treatment outcomes ( Figure 1). As a result, TAVI is increasingly being considered as a less-invasive option for treatment of AS in younger and lower surgical risk patients, where SAVR is not necessarily contraindicated (6,7), although this is not without controversy (8).While the short-term outcomes of TAVI have been well explored, limited studies have examined longer term results (9,10). Additiona...

show abstract

Section: Tavi Trials Expanding Indications and Criticismsmentioning

confidence: 99%

Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond

Chakos

Wilson-Smith

Arora

et al. 2017

Ann. Cardiothorac. Surg.

View full text Add to dashboard Cite

show abstract

“…The insidious development of left ventricular function impairment is not rare and when present the prognosis becomes extremely poor, the operative mortality increases exponentially and reversibility of the systolic function is not certain. Recently, there have been reports of the off-label use of the MCV and the Edwards SAPIEN prostheses for the management of inoperable pure severe AR [13][14][15]. Although the feasibility with both devices was demonstrated, certain technical limitations were found, since they were designed for implantation into calcified aortic valves through radial expansion at the annular plane level.…”

Section: Tavi In Pure Armentioning

confidence: 99%

Update on current TAVI technology, indications, screening, and outcomes

Halapas

Chrissoheris

Bouboulis

et al. 2016

Continuing Cardiol Educ

View full text Add to dashboard Cite

Transcatheter aortic valve replacement (TAVI) is an established treatment for inoperable patients or patients at high surgical risk with severe aortic stenosis. Herein, we illustrate the key design features of the main new generation devices that are entering contemporary clinical practice, the labeled and off-labeled indications, the basic principles of screening process, and the clinical outcomes of the TAVI procedure.Answer questions and earn CME: https://wileyhealthlearning.com/Activity2/ 4193543/Activity.aspx TAVI New TechnologyDespite growing experience with transcatheter aortic valve replacement (TAVI) the first-generation devices were associated with several limitations such as: valve malpositioning, vascular complications, paravalvular regurgitation (PVR), and conduction disorders [1,2]. Several new generation TAVI devices (Table 1), aimed at addressing these issues. Medtronic Evolut-R TMThe Evolut-R TM is the new iteration of the Medtronic CoreValve â (MCV), ( Figure 1A). Several key features of the MCV have been preserved, namely the trileaflet porcine pericardial tissue, the supra-annular position of the valve leaflets, the self-expanding nitinol stent frame and the architecture in three levels of function: inflow portion with a high radial force for anchoring within the aortic annulus, mid portion with a constrained structure for preservation of the coronary flow, and outflow portion with a high hoop strength for coaxiality with the aortic root. However, the new generation Evolut-R TM presents several improvements namely:) the inflow portion is wider and more cylindrical providing a flatter landing zone to ensure maximum over-sizing within the full target implant depth range, (iii) the geometry of the distal diamond cell of the inflow portion has been modified with a slightly asymmetric configuration and extended length for better conformability and consistent radial force across a range of annulus sizes, (iv) the distal skirt has been extended with a scalloped design creating a longer landing zone for better sealing, (v) the prosthesis is fully repositionable and retrievable before final detachment of the hooks (up to three times) and, (vi) the 14 Fr profile of the delivery system (true outer diameter 18 Fr), with the option of proceeding to sheath-less procedures reduces the rate of vascular complications. At the moment the device is available in three sizes (23, 26, and 29 mm) covering aortic annuli from 18 to 26 mm. In addition, whereas positioning of the actual MCV can be sometimes challenging, the 1:1 ratio applied to the handle and prosthesis unsheathing-resheathing response aims at ª 2016 Hellenic College of Cardiology

show abstract

“…However, indications have recently expanded significantly to encompass the treatment of bicuspid valves, 25 aortic regurgitation 26 and degenerating aortic and mitral bioprostheses. 27 Long-term results concerning the efficacy of these procedures are awaited before adoption into routine clinical practice.…”

Section: Expanding Indicationsmentioning

confidence: 99%

Transcatheter aortic valve implantation – what the general physician needs to know

Ruparelia

Prendergast

2015

Clinical Medicine

View full text Add to dashboard Cite

with a 5-10% risk of major adverse perioperative events and a mortality of up to 20% at one year. 5 Given this prohibitively high surgical risk, these patients have historically refused or been denied surgery with no alternative treatment option.Following the first successful human implantation in 2002, 6 transcatheter aortic valve implantation (TAVI) has rapidly developed over the past few years and is now the established treatment option for inoperable or high-risk surgical patients with severe symptomatic AS. 7 In this article, we will summarise the current evidence base and discuss factors that need to be taken into account by the general physician when considering TAVI as a treatment option, including practical aspects and future directions. Current evidenceFollowing the first successful TAVI in 2002, 6 the feasibility, efficacy and safety of the procedure were subsequently confirmed in a number of single-and multi-centre registries. 8 The Placement of AoRTic TraNscathetER Valves (PARTNER) trials were the first prospective randomised studies to compare outcomes of TAVI using the balloon-expandable (BE) Edwards Sapien valve (Edwards LifeSciences, Irvine, CA, USA) with medical management in inoperable patients 9 (cohort B) and with SAVR in patients of high surgical risk (cohort A). 10 When compared with medical therapy (plus balloon aortic valvuloplasty as required), TAVI resulted in a significant reduction in one-year mortality (30.7 vs 50.1%) that was maintained at three-year follow-up (54.1 vs 80.9%). 11 When TAVI was compared with SAVR in high-risk individuals, all-cause mortality was slightly lower with TAVI at 30 days (3.4 vs 6.5%, p=0.07) but comparable three years following implantation (44.2 vs 44%) with long-term symptomatic improvement sustained in both groups. 12 Of late, results of two more contemporary TAVI trials were reported. The non-randomised CoreValve US extremerisk pivotal trial described outcomes of TAVI using the self-expandable (SE) Medtronic CoreValve (Medtronic Inc., Minneapolis, MN, USA) in inoperable patients and demonstrated the efficacy of this treatment option with a 40% reduction in the one-year combined endpoint of all-cause mortality and stroke. 13 The randomised CoreValve US high-risk pivotal trial compared the same device with SAVR in patients deemed to be of high surgical risk. For the first time, TAVI was shown to be associated with a mortality benefit (14.2 vs 19.1%; p<0.0001 for non-inferiority and p=0.04 for superiority).With an increasingly elderly population, the incidence of aortic stenosis (AS) is rising. While surgical aortic valve replacement remains the gold standard treatment for patients with severe symptomatic AS, transcatheter aortic valve implantation (TAVI) has emerged as the treatment of choice for patients who are inoperable or high surgical risk. TAVI has been shown to be associated with a clear mortality benefit when compared with medical therapy and to be at least as good as surgical aortic valve replacement in this patient group. The last few years h...

show abstract

Transcatheter Aortic Valve Implantation for Pure Severe Native Aortic Valve Regurgitation

Cited by 261 publications

References 31 publications

Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond

Long term outcomes of transcatheter aortic valve implantation (TAVI): a systematic review of 5-year survival and beyond

Update on current TAVI technology, indications, screening, and outcomes

Transcatheter aortic valve implantation – what the general physician needs to know

Contact Info

Product

Resources

About