Factors Predicting and Having an Impact on the Need for a Permanent Pacemaker After CoreValve Prosthesis Implantation Using the New Accutrak Delivery Catheter System

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

“…In studies that predominantly used the CoreValve, heart block requiring PPMI was a common complication after TAVI, with an incidence of 31.3% and 24.7% for men and women, respectively. 5,23,26,31,32 However, the rate of PPMI was much lower in studies mainly using Edwards valve, 8.0% in men and 7.4% in women. [6][7][8]17 The pooled results of sex-related differences in this outcome Figure 4).…”

Section: Permanent Pacemaker Implantationmentioning

confidence: 98%

“…[5][6][7][8]17,23,26,31,32 Data on 1719 men and 2145 women were available for analysis. In studies that predominantly used the CoreValve, heart block requiring PPMI was a common complication after TAVI, with an incidence of 31.3% and 24.7% for men and women, respectively.…”

Section: Permanent Pacemaker Implantationmentioning

confidence: 99%

Sex-Related Differences in Outcomes After Transcatheter Aortic Valve Implantation

Zhang

Liao

Peng

et al. 2013

Studies were initially screened at the level of title and abstract, and then full-length reports were retrieved for detailed evaluation. Two authors independently selected articles according to prespecified inclusion and exclusion criteria. Articles were included if they (1) reported Background-There were considerable discrepancies with regard to sex-related differences in complications and prognosis after transcatheter aortic valve implantation. Methods and Results-The Cochrane library and PubMed online databases were searched. Articles reporting sex-specific post-transcatheter aortic valve implantation complications and mortality were identified. Two authors selected studies and extracted data independently. Random-and fixed-effects models were used depending on between-study heterogeneity. There were 27 articles, a total of 9118 patients, enrolled in our systematic review and meta-analysis, including 4176 men and 4942 women. Pooled analyses suggested considerable sex-related differences in complications and early as well as midterm outcomes after transcatheter aortic valve implantation. The difference in the risk for heart block requiring permanent pacemaker implantation was noted to be significant only in the subgroup of the CoreValve-dominating studies (pooled risk ratio [RR, men versus women], 1.29; 95% confidence interval [CI], 1.13-1.47). Although men had significantly lower risks for major/life-threatening bleeding (pooled RR, 0.81; 95% CI, 0.68-0.96) and major vascular complications (pooled RR, 0.49; 95% CI, 0.37-0.66), they had poorer prognosis. In fact, male sex was associated with significantly higher risks for deaths at both 30 days (RR, 1.37; 95% CI, 1.07-1.76) and 1 year (RR, 1.30; 95% CI, 1.14-1.49). Conclusions-Although men had lower risks for major/life-threatening bleeding and major vascular complications after transcatheter aortic valve implantation, they had less favorable short-term and midterm survival. (Circ Cardiovasc Interv. 2013;6:543-551.)

“…Despite the fact that the incidence of these conduction disturbances and PPI has slowly decreased over time, 3 this effect seems to be limited to patients receiving a SEV and is partially related to significant reductions in valve implantation depths and improvement in the delivery systems. 34 Furthermore, the incidence of major periprocedural complications post-TAVR has decreased dramatically in recent times after the adoption of new valve technologies. However, early results show a lack of reduction, or even an increase in the rate of conduction system disturbances associated with these so-called new-generation valves.…”

Section: Downloaded From Impact Of Conduction Disturbances Post-tavrmentioning

confidence: 99%

Impact of New-Onset Left Bundle Branch Block and Periprocedural Permanent Pacemaker Implantation on Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement

Regueiro

Altisent

Trigo

et al. 2016

245

138

Background-Available data on the clinical impact of new-onset left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR) remains controversial. We aimed to evaluate the impact of (1) periprocedural new-onset LBBB or PPI post-TAVR on cardiac mortality and all-cause 1-year mortality and (2) new-onset LBBB on the need for PPI at 1-year follow-up. Methods and Results-We performed a systematic search from PubMed and EMBASE databases for studies reporting raw data on new-onset LBBB post-TAVR and the need for PPI or mortality at 1-year follow-up, or on 1-year mortality according to the need for periprocedural PPI post-TAVR. Data from 17 studies, including 4756 patients (8 studies) and 7032 patients (11 studies) for the evaluation of the impact of new-onset LBBB and periprocedural PPI post-TAVR were sourced, respectively (with 2 studies used for both outcomes). New-onset LBBB post-TAVR was associated with a higher risk of PPI (risk ratio [RR], 2.18; 95% confidence interval [CI], 1.28-3.70) and cardiac death (RR, 1.39; 95% CI, 1.04-1.86) during follow-up, as well with a tendency toward an increase in all-cause mortality (RR, 1.21; 95% CI, 0.98-1.50). Periprocedural PPI post-TAVR was not associated with any increased risk of all-cause mortality at 1 year (RR, 1.03; 95% CI, 0.9-1.18), yet a tendency toward a protective effect on cardiac death was observed (RR, 0.78; 95% CI, 0.60-1.03). Conclusions-New-onset LBBB post-TAVR is a marker of an increased risk of cardiac death and need for PPI at 1-year follow-up. The need for PPI early post-TAVR did not increase the risk of death. (Circ Cardiovasc Interv. 2016;9:e003635.