Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve

Background— Transcatheter aortic valve replacement has become the procedure of choice for inoperable, high-risk, and many intermediate-risk patients with aortic stenosis. Conduction abnormalities are a common finding after transcatheter aortic valve replacement and often result in permanent pacemaker (PPM) implantation. Data pertaining to the clinical impact of PPM implantation are controversial. We used meta-analysis techniques to summarize the effect of PPM implantation on clinical and echocardiographic outcomes after transcatheter aortic valve replacement. Methods and Results— Data were summarized as Mantel–Haenszel relative risk (RR) and 95% confidence intervals (CIs) for dichotomous variables and as standardized mean difference and 95% CI for continuous variables We used the Higgins I 2 statistic to evaluate heterogeneity. We found that patients with and without PPM have similar all-cause mortality (RR, 0.85; 95% CI, 0.70–1.03), cardiovascular mortality (RR, 0.84; 95% CI, 0.59–1.18), myocardial infarction (RR, 0.47; 95% CI, 0.20–1.11), and stroke (RR, 1.26; 95% CI, 0.70–2.26) at 30 days. The groups were also comparable in all-cause mortality (RR, 1.03; 95% CI, 0.92–1.16), cardiovascular mortality (RR, 0.69; 95% CI, 0.39–1.24), myocardial infarction (RR, 0.58; 95% CI, 0.30–1.13), and stroke (RR, 0.70; 95% CI, 0.47–1.04) at 1 year. We observed that the improvement in left ventricular ejection fraction was significantly greater in the patients without PPM (standardized mean difference, 0.22; 95% CI, 0.12–0.32). Conclusions— PPM implantation is not associated with increased risk of all-cause mortality, cardiovascular mortality, stroke, or myocardial infarction both at short- and long-term follow-up. However, PPM is associated with impaired left ventricular ejection fraction recovery post-transcatheter aortic valve replacement.

Section: Discussionmentioning

confidence: 99%

Clinical and Echocardiographic Outcomes Following Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement

Mohananey

Jobanputra

Kumar

et al. 2017

“…33 In contrast, Tarantini and colleagues reported a seemingly excessive pacemaker rate of 20.7% for the S3-THV, which was related to an implantation depth ≥8 mm. 34 Only 2 of the S3-THVs in this study were implanted that deep (in one case leading to persistent complete heart block and pacemaker implantation). High placement of the S3-THV is preferable in our experience, not only to evade conduction disturbances associated with deep implantations, but also to take full advantage of the sealing properties of the external cuff when positioned within (or just below) the aortic annulus.…”

Section: Discussionmentioning

confidence: 99%

Transcatheter Aortic Valve Implantation With the New Balloon-Expandable Sapien 3 Versus Sapien XT Valve System

Nijhoff

Abawi

Agostoni

et al. 2015

T ranscatheter aortic valve implantation (TAVI) has become a firmly established treatment option for symptomatic severe aortic stenosis (AS) in inoperable patients 1 and patients at high operative risk. 2,3 Although proven noninferior to surgical aortic valve replacement in terms of all-cause mortality, TAVI is associated with a higher incidence of postoperative aortic regurgitation (AR) and vascular complications. 2,3 Other non-negligible TAVI-related complications are cerebral embolic events and advanced conduction disturbances. 4 The extension of TAVI to lower risk populations requires minimization of these adverse events, partly depending on technological developments in transcatheter heart valves (THVs) and delivery systems.Recently, the new balloon-expandable Sapien 3 THV (S3-THV; Edwards Lifesciences, Irvine, CA) has become commercially available. 5 The S3-THV embodies the next generation balloon-expandable valve of the Sapien valve family, building on the clinical experiences gained with the previous Sapien XT-THV (SXT-THV; Edwards Lifesciences). With its new features, including an outer annular sealing cuff, improved delivery system, and low crimped profile, the S3-THV is thought to achieve better results than the preceding SXT-THV. 5 Initial data from a multicenter registry prospectively evaluating the S3-THV looked promising, reporting low rates of AR, vascular complications, and stroke. 6 Comparative studies on the clinical outcomes of TAVI with the S3-THV and SXT-THV are currently scarce.Aim of this study was to retrospectively compare the hemodynamic and clinical outcomes of TAVI with the S3-THV versus the SXT-THV in patients with symptomatic severe native AS.Background-The new balloon-expandable Sapien 3 transcatheter heart valve (S3-THV) incorporates new features to reduce aortic regurgitation (AR) and vascular complications in transcatheter aortic valve implantation. Aim of this study is to compare the outcomes of the S3-THV with the preceding Sapien XT THV (SXT-THV) in patients who underwent transcatheter aortic valve implantation for symptomatic severe native aortic stenosis. Methods and Results-Eligible patients were retrospectively identified in our institutional database and periprocedural clinical and imaging data were collected. Non-parsimonious one-to-many propensity score matching was performed to account for differences in baseline characteristics. Between November 2011 and December 2014, 167 patients underwent balloon-expandable transcatheter aortic valve implantation with either the S3-THV (n=49) or SXT-THV (n=118 MethodsThis is a retrospective single-center study. All patients who underwent TAVI for severe native AS at the University Medical Center Utrecht by means of S3-THV or SXT-THV implantation were identified in our institutional database and included in the study. Implantation of the SXT-THV had to be state-of-the-art, meaning performed with the Novaflex+ delivery system through an expandable sheath. Patients with bicuspid aortic valve anatomy or a degenerated surgical aortic...

“…Although the initial manufacturer recommendation was to place the middle marker of the deployment balloon in the annular plane, current clinical practice demonstrates that a high implant in experienced hands can be safely performed and may reduce atrioventricular conduction dusturbances. 36 Overall, there seems to be no prognostic impact of a new PPM after TAVI.…”

Section: Permanent Pacemaker Implantationmentioning

confidence: 99%

Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland

Binder¹,

Stortecky²,

Heg³

et al. 2015