Abstract
Objectives
We herein report a single-center experience with the Portico TAVI system. Main focus was set on outcomes in patients with impaired left ventricular (LV) function and predictors for permanent pacemaker (PPM) implantation.
Methods
Between 05/2014 and 10/2017, 106 consecutive patients received TAVI using the Portico device. For comparison of patients with/without impaired LV function, and determination of multi-slice computed tomography and electrocardiogram correlates for PPM implantation subgroups were built (Subgroup I: LVEF ≥ 50%, n = 69, Subgroup II: LVEF < 50%, n = 37; Subgroup A: no PPM implantation, n = 89; Subgroup B: PPM implantation, n = 17). Data were retrospectively analyzed.
Results
Device success was 95.3% (101/106) with resulting transvalvular peak/mean pressure gradients of 10.6 ± 5.6/5.4 ± 3.1 and PVL ≥ moderate in 5/106 patients (4.7%). 30-day mortality was 4.7% (5/106; subgroup I 3/69, 4.3%; subgroup II 2/37, 5.4%; p = 1.0). Regarding VARC-2 adjudicated clinical endpoints stroke (3/106, 2.8%; subgroups I/II: 2/69 vs. 1/37, p = 1.0) and acute kidney injury (9/106, 8.5%; subgroups I/II: 6/69 vs. 3/37, p = 1.0), no significant differences were found. Postprocedural PPM implantation occurred in 17.9% (19/106) of the patients. Logistic regression for PPM implantation demonstrated predictive character of left coronary cusp (LCC) calcium load in zone 1 (annular plane to coronary ostia) (p = 0.05, threshold 193 mm3) and total calcium load of zone 1 (p = 0.05, threshold 751.2 mm3).
Conclusions
The Portico valve demonstrates a satisfying safety outcome, especially for patients with impaired LV function. Results of the CE-mark trial were confirmed, except for higher PPM rates. PPM rates are in accordance with other reports on this TAVI platform.
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Abbreviations
- AS:
-
Aortic valve stenosis
- AVB:
-
Atrioventricular block
- BE:
-
Balloon-expandable
- EOA:
-
Effective orifice area
- LBBB:
-
Left bundle branch block
- LV:
-
Left ventricular
- LVEF:
-
Left ventricular ejection fraction
- MSCT:
-
Multi-slice computed tomography
- PPM:
-
Permanent pacemaker
- PVL:
-
Paravalvular leakage
- RBBB:
-
Right bundle branch block
- ROC:
-
Receiver operating characteristic
- SE:
-
Self-expandable
- TAVI:
-
Transcatheter aortic valve implantation
- TEE:
-
Transesophageal echocardiography
- TF:
-
Transfemoral
- THV:
-
Transcatheter heart valve
- TTE:
-
Transthoracic echocardiography
- VARC:
-
Valve Academic Research Consortium
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U. Schäfer is a consultant to Abbott vascular and St Jude Medical has received speakers honoraria, travel support, and study grants. In addition, he serves as a Proctor for Portico implantations. All other authors have nothing to disclose.
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Schaefer, A., Neumann, N., Linder, M. et al. Outcomes with a latest generation self-expandable, intra-annular, re-sheathable transcatheter heart valve system: analysis of patients with impaired left ventricular function and determinants for pacemaker implantation. Clin Res Cardiol 107, 914–923 (2018). https://doi.org/10.1007/s00392-018-1263-x
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DOI: https://doi.org/10.1007/s00392-018-1263-x