P3738Clinical outcomes after early vs new generation TAVR device deployment

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
L Kalinczuk ◽  
Z Chmielak ◽  
K Zielinski ◽  
G S Mintz ◽  
M Dabrowski ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Pacemaker Implantation ◽  
Real Life ◽  
Permanent Pacemaker ◽  
Early Generation ◽  
Permanent Pacemaker Implantation ◽  
Safety Endpoint ◽  
New Generation

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).

scholarly journals Prevalence of permanent pacemaker implantation after conventional aortic valve replacement—a propensity-matched analysis in patients with a bicuspid or tricuspid aortic valve: a benchmark for transcatheter aortic valve replacement

2020 ◽  
Vol 58 (1) ◽  
pp. 130-137 ◽  
Author(s):  
Josephina Haunschild ◽  
Martin Misfeld ◽  
Thomas Schroeter ◽  
Frank Lindemann ◽  
Piroze Davierwala ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Transcatheter Aortic Valve Replacement ◽  
Pacemaker Implantation ◽  
Permanent Pacemaker ◽  
Tricuspid Aortic Valve ◽  
Permanent Pacemaker Implantation ◽  
Transcatheter Aortic Valve

Abstract OBJECTIVES Elective treatment of aortic valve disease by transcatheter aortic valve replacement (TAVR) is becoming increasingly popular, even in patients with low risk and intermediate risk. Even patients with a bicuspid aortic valve (BAV) are increasingly considered eligible for TAVR. Permanent pacemaker implantation (PMI) is a known—frequently understated—complication of TAVR affecting 9–15% of TAVR patients with a potentially significant impact on longevity and quality of life. BAV patients are affected by the highest PMI rates, although they are frequently younger compared to their tricuspid peers. The aim of the study is to report benchmark data—from a high-volume centre (with a competitive TAVR programme) on PMI after isolated surgical aortic valve replacement (SAVR) in patients with BAV and tricuspid aortic valve (TAV). METHODS We performed a retrospective single-centre analysis on 4154 patients receiving isolated SAVRs (w/o concomitant procedures), between 2000 and 2019, of whom 1108 had BAV (27%). PMI rate and early- and long-term outcomes were analysed. For better comparability of these demographically unequal cohorts, 1:1 nearest neighbour matching was performed. RESULTS At the time of SAVR, BAV patients were on average 10 years younger than their TAV peers (59.7 ± 12 vs 69.3 ± 9; P &lt; 0.001) and had less comorbidities; all relevant characteristics were equally balanced after statistical matching. Overall PMI rate was significantly higher in BAV patients (5.4% vs 3.8%; P = 0.03). BAV required PMI exclusively (100%) and TAV required predominately (96%) for persistent postoperative high-degree atrioventricular block. After matching, the PMI rate was similar (5.1% vs 4.4%, P = 0.5). In-hospital mortality in the matched cohort was 1% in both groups. Long-term survival was more favourable in BAV patients (94% vs 90% in TAV at 5 years; 89% vs 82% in TAV at 9 years; P = 0.013). CONCLUSIONS With SAVR, the overall incidence of PMI among BAV patients seems significantly higher; however, after propensity matching, no difference in PMI rates between BAV and TAV is evident. The PMI rate was remarkably lower among BAV patients after SAVR compared to the reported incidence after TAVR.

LONG-TERM FOLLOW-UP OF PATIENTS UNDERGOING PERMANENT PACEMAKER IMPLANTATION: GATA EXPERIENCE

2015 ◽  
Vol 57 (4) ◽  
pp. 408
Author(s):  
Turgay Celik ◽  
Esra Goktas ◽  
Hasan Kabul ◽  
Sevket Balta ◽  
Atila Iyisoy ◽  
...  
Keyword(s):  
Pacemaker Implantation ◽  
Permanent Pacemaker ◽  
Permanent Pacemaker Implantation ◽  
Long Term Follow Up

Abstract 17215: Pacing Burden in Those Undergoing Permanent Pacemaker Implantation After TAVR With Latest Generation Valves

Circulation ◽  
2018 ◽  
Vol 138 (Suppl_1) ◽  
Author(s):  
Amneet Sandhu ◽  
Karen Ream ◽  
Wendy Tzou ◽  
Alexis Tumolo ◽  
Blake Fleeman ◽  
...  
Keyword(s):  
Heart Valves ◽  
Pacemaker Implantation ◽  
Permanent Pacemaker ◽  
System Disease ◽  
Edwards Sapien ◽  
Conduction System Disease ◽  
Rv Pacing ◽  
New Generation

Background: Risk factors leading to heart block (HB) and need for permanent pacemaker (PPM) implantation post-TAVR using latest generation heart valves have been described. Yet, little is known regarding pacing burden following PPM implantation among such patients. Objective: We sought to determine follow-up RV pacing burden among those undergoing PPM for HB following TAVR. Methods: From July 2016 to July 2017, we reviewed procedural and 3-month follow-up data (including PPM interrogation data) from all patients undergoing implantation of Edwards Sapien 3® and Medtronic Evolut-R® valves at our institution and requiring implantation of a PPM due to HB secondary to the TAVR procedure. Results: Of 132 included patients who underwent TAVR with new generation valves, 25 (19%) required post-TAVR PPM implantation. Of 25 patients, 18 had available follow-up pacemaker data [Table]. Pacing burden post-PPM implantation of 29mm valves was significantly greater compared to non-29mm valves (40.2% vs. 5.4%, p = 0.02). Those with baseline conduction system disease (RBBB or LBBB) had greater pacing burdens, in particular when 29mm Evolut-R® self-expanding valves were deployed (n=3, RV pacing burden 63.3%). Extension of programmed AV delays produced significant reduction in RV pacing burden. Conclusion: In those undergoing TAVR with latest generation valves complicated by HB requiring PPM use, implantation of larger-sized valves (29 mm Evolut-R® in the present series), as well as baseline RBBB or LBBB results in increased follow-up RV pacing burden. This may be mitigated by adjustment of pacing parameters. Further work investigating long-term pacing burden and its consequences is needed to provide additional insight. Table: Demographics, baseline ECG characteristics, procedural characteristics, pacing mode, pacing parameters and follow-up RV pacing burden.

Permanent Pacemaker Implantation Following Cardiac Surgery: Indications and Long-Term Follow-Up

2009 ◽  
Vol 32 (1) ◽  
pp. 7-12 ◽  
Author(s):  
OFER MERIN ◽  
MICHAEL ILAN ◽  
AVRAHAM OREN ◽  
DANIEL FINK ◽  
MAHER DEEB ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Pacemaker Implantation ◽  
Permanent Pacemaker ◽  
Permanent Pacemaker Implantation ◽  
Long Term Follow Up

26 Permanent pacemaker implantation following cardiac surgery: indications and long term follow up

EP Europace ◽  
2005 ◽  
Vol 7 (Supplement_1) ◽  
pp. 5-6
Author(s):  
O. Merin ◽  
M. Ilan ◽  
D. Fink ◽  
A. Oren ◽  
M. Deeb ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Pacemaker Implantation ◽  
Permanent Pacemaker ◽  
Permanent Pacemaker Implantation ◽  
Long Term Follow Up

scholarly journals 628 Long-term clinical impact of permanent pacemaker implantation in patients undergoing transcatheter aortic valve intervention: a systematic review and meta-analysis

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Andrea Zito ◽  
Giuseppe Princi ◽  
Marco Lombardi ◽  
Domenico D’A Mario ◽  
Rocco Vergallo ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Heart Failure ◽  
Aortic Valve ◽  
Meta Analysis ◽  
Pacemaker Implantation ◽  
Permanent Pacemaker ◽  
Clinical Impact ◽  
Transcatheter Aortic Valve

Abstract Aims As compared with surgery, transcatheter aortic valve implantation (TAVI) is associated with increased need for permanent pacemaker implantation (PPMI). The clinical impact of PPMI post-TAVI has not been fully established. To assess by an updated meta-analysis the clinical outcomes related to PPMI after TAVI at long-term (≥12 months) follow-up (LTF). Methods and results A comprehensive literature research was performed on PubMed and EMBASE. The primary endpoint was all-cause death. Secondary endpoints were rehospitalization for heart failure, stroke, and myocardial infarction. A subgroup analysis was performed according to Society of Thoracic Surgeon—Predicted Risk of Mortality (STS-PROM) score. A total of 31 studies were identified, providing data on 51 069 patients. The mean duration of follow-up was 22 months. At LTF, PPMI post-TAVI was associated with a higher risk of all-cause death [22.9% vs. 19.6%; risk ratio (RR), 1.18, 95% confidence interval (CI), 1.10–1.25; P &lt; 0.001] and rehospitalization for heart failure (16.6% vs. 15.1%; RR, 1.32; 95% CI, 1.13–1.52; P &lt; 0.001). In contrast, risks of stroke and myocardial infarction were not affected. Among the 20 studies that reported surgical risk, the association between PPMI and LTF all-cause death risk was statistically significant only in studies enrolling patients with high STS-PROM score (RR, 1.25; 95% CI, 1.12–1.40), although there was a similar trend in those at medium and low-risk. Conclusions Patients necessitating PPMI after TAVI have higher long-term risk of all-cause death and rehospitalization for heart failure as compared to those who do not receive PPMI. Thus, strategies aimed at reducing need for PPMI might improve survival after TAVI.

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