Abstract
Background
Whether newer generation devices influence early and long-term outcomes post-TAVR in a real life setting is unknown.
Aim
To assess impact of an early vs a new generation transcatheter heart valves (THV) on clinical outcomes (30-day and -years) in a real life scenario.
Methods
Out of 445 consecutive pts treated between 8/2009 and 10/2017 within the single-center, prospective TAVR Registry, there were 432 [median 83.0 years of age, 63.4% female] with device success (97.1%) as per VARC-2. Early generation THV included: CoreValve; Edwards SAPIEN or SAPIEN XT. Newer generation devices included: Evolut-R/-Pro; Acurate neo; Engager, SAPIEN 3; or Lotus Edge Aortic Valve System.
Results
Median follow-up was 29.3 (15.8–53.1) months with 100% 1-year follow-up. Early generation devices were deployed in 60.6% (n=262) and new devices in 39.4% (n=170). Pts treated with newer devices had more peripheral arterial disease (PAD) and more frequent PCI history (17.1% vs 8.8%, p=0.015, and 35.3% vs 26.7%, p=0.068 respectively); other demographic and clinical data were alike. Baseline aortic valve area and LV ejection fraction were similar between early and newer devices. Pre-dilation was less frequent with newer devices (41.8% vs 70.6%, p<0.001), whereas THV size, contrast volume, fluoroscopy time, radiation dose, and post-procedure aortic valve gradients were similar. Moderate PVL assessed early post-TAVR was recognized with same frequency between earlier vs newer devices (28.2% vs 28.6%). An VARC-2 safety endpoint was recognized more often among pts treated with early vs new devices (30.5% vs 21.8%, p=0.028, respectively), with more frequent: 30-day death (3.8% vs 1.8%, p=0.177), life-threatening or disabling bleeding (8.4% vs 5.3%, p=0.181), major vascular complications (20.2% vs 15.3%, p=0.121), and new permanent pacemaker implantation (22.9% vs 10.0%, p=0.001) with early devices, but similar frequencies of stroke and acute kidney injury (1.9% vs 1.8% and 3.8% vs 5.9%, respectively). The 1-year mortality rates were similar (13.4% vs 13.5%, respectively), with similar estimated midterm (1–2 years) prognosis, but worse estimated very long-term follow-up for newer THV devices (fig 1).
Figure 1
Conclusions
Newer TAVR devices with smaller delivery system size, although deployed in pts with more PAD and PCI history, are associated with less frequent occurrence of an VARC-2 safety endpoint and less frequent permanent pacemaker implantation. The 1-year and midterm (1–2 years) prognosis are similar for early and newer devices, whereas the longer follow-up could have been influenced by intrinsic pt characteristics (more frequent PAD and history of PCI).
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