Pacemaker dependency after transcatheter aortic valve replacement compared to surgical aortic valve replacement.
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ABSTRACT: Abstract
Transcatheter aortic valve replacement (TAVR) is a standard treatment indicated for severe aortic stenosis in high-risk patients. The objective of this study was to evaluate the incidence of pacemaker dependency after permanent pacemaker implantation (PPI) following TAVR or surgical aortic valve replacement (SAVR) and the risk of mortality at a tertiary center in Korea.In this retrospective study conducted at a single tertiary center, clinical outcomes related to pacemaker dependency were evaluated for patients implanted with pacemakers after TAVR from January 2012 to November 2018 and post-SAVR from January 2005 to May 2015. Investigators reviewed patients' electrocardiograms and baseline rhythms as well as conduction abnormalities. Pacemaker dependency was defined as a ventricular pacing rate > 90% with an intrinsic rate of <40 bpm during interrogation.Of 511 patients who underwent TAVR for severe AS, 37(7.3%) underwent PPI after a median duration of 6 (3-7) days, whereas pacemakers were implanted after a median interval of 13 (8-28) days post-SAVR in 10 of 663 patients (P < .001). Pacemaker dependency was observed in 36 (97.3%) patients during 7 days immediately post-TAVR and in 25 (64.9%) patients between 8 and 180 days post-TAVR. Pacemaker dependency occurred after 180 days in 17 (50%) patients with TAVR and in 4 (44.4%) patients with SAVR. Twelve (41.4%) patients were pacemaker-dependent after 365 days post-TAVR.Pacemaker dependency did not differ at 6 months after TAVR vs SAVR. In patients undergoing post-TAVR PPI, 58.6% were not pacemaker-dependent at 1 year after the TAVR procedure.
SUBMITTER: Hwang YM
PROVIDER: S-EPMC8183801 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background As transcatheter aortic valve replacement expands to younger and/or lower risk patients, the long-term consequences of permanent pacemaker implantation are a concern. Pacemaker dependency and impact have not been methodically assessed in transcatheter aortic valve replacement trials. We report the incidence and predictors of pacemaker implantation and pacemaker dependency after transcatheter aortic valve replacement with the Lotus valve. Methods and Results A total of 912 patients with high/extreme surgical risk and symptomatic aortic stenosis were randomized 2:1 (Lotus:CoreValve) in REPRISE III (The Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System-Randomized Clinical Evaluation) trial. Systematic assessment of pacemaker dependency was pre-specified in the trial design. Pacemaker implantation within 30 days was more frequent with Lotus than CoreValve. By multivariable analysis, predictors of pacemaker implantation included baseline right bundle branch block and depth of implantation; diabetes mellitus was also a predictor with Lotus. No association between new pacemaker implantation and clinical outcomes was found. Pacemaker dependency was dynamic (30 days: 43%; 1 year: 50%) and not consistent for individual patients over time. Predictors of pacemaker dependency at 30 days included baseline right bundle branch block, female sex, and depth of implantation. No differences in mortality or stroke were found between patients who were pacemaker dependent or not at 30 days. Rehospitalization was higher in patients who were not pacemaker dependent versus patients without a pacemaker or those who were dependent. Conclusions Pacemaker implantation was not associated with adverse clinical outcomes. Most patients with a new pacemaker at 30 days were not dependent at 1 year. Mortality and stroke were similar between patients with or without pacemaker dependency and patients without a pacemaker. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier NCT02202434.
| S-EPMC6898843 | biostudies-literature
Project description:Background:Atrioventricular block requiring permanent pacemaker (PPM) implantation is a common complication of transcatheter aortic valve replacement (TAVR). The mechanism of atrioventricular (AV) block during TAVR is not fully understood, but it may be due to the mechanical stress of TAVR deployment, resulting in possible injury to the nearby compact AV node. Aortic valve calcification (AVC) may worsen this condition and has been associated with an increased risk for post-TAVR PPM implantation. We performed a retrospective analysis to determine if AVC is predictive for long-term right ventricular (RV) pacing in post-TAVR pacemaker patients at 30 days. Methods:A total of 262 consecutive patients who underwent TAVR with a balloon-expandable valve were analyzed. AVC data were derived from contrast-enhanced computed tomography and characterized by leaflet sector and region. Results:A total of 25 patients (11.1%) required post-TAVR PPM implantation. Seventeen patients did not require RV pacing at 30 days. Nine of these 17 patients had no RV pacing requirement within 10 days. The presence of intra-procedural heart block (P = 0.004) was the only significant difference between patients who did not require PPM and those who required PPM but they were not RV pacing-dependent at 30 days. Non-coronary cusp (NCC) calcium volume was significantly higher in patients who were pacemaker-dependent at 30 days (P = 0.01) and a calcium volume of > 239.2 mm3 in the NCC was strongly predictive of pacemaker dependence at 30 days (area under the curve (AUC) = 0.813). Pre-existing right bundle branch block (RBBB) (odds ratio (OR) 105.4, P = 0.004), bifascicular block (OR 12.5, P = 0.02), QRS duration (OR 70.43, P = 0.007) and intra-procedural complete heart block (OR 12.83, P = 0.03) were also predictive of pacemaker dependence at 30 days. Conclusions:In patients who required PPM after TAVR, quantification of AVC by non-coronary leaflet calcium volume was found to be a novel predictor for RV pacing dependence at 30 days. The association of NCC calcification and PPM dependence may be related to the proximity of the conduction bundle to the non-coronary leaflet. Further studies are necessary to improve risk prediction for long-term RV pacing requirements following TAVR.
| S-EPMC7239596 | biostudies-literature
Project description:ImportanceThe Centers for Medicare & Medicaid Services national coverage determination for transcatheter aortic valve replacement (TAVR) includes volume requirements for surgical aortic valve replacement (SAVR) for hospitals seeking to initiate or continue TAVR programs. Evidence regarding the association between SAVR volume and TAVR outcomes is limited.ObjectiveTo examine the association of hospital SAVR and combined SAVR and TAVR volumes with patient outcomes of TAVR procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs.Design, setting, and participantsThis observational cohort study included 60 538 TAVR procedures performed in 438 hospitals between October 1, 2011, and December 31, 2015, among Medicare beneficiaries.Main outcomes and measuresThe associations between SAVR volume, SAVR and TAVR volumes, and risks of death, death or stroke, and readmissions within 30 days were determined using a hierarchical logistic regression model adjusting for patient and hospital characteristics. The association between SAVR and SAVR and TAVR volumes and 1-year and 2-year mortality after TAVR procedures was determined using a multivariable proportional hazard model with a robust variance estimator. The associations for procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs were examined.ResultsAmong the 60 538 patients, 29 173 were women and 31 365 were men, with a mean (SD) age of 82.3 (8.0) years. Hospitals with high SAVR volume (mean annual volume, ≥97 per year) were more likely to adopt TAVR early and had a higher growth in TAVR volumes over time (median TAVR volume by hospitals with high SAVR volume and low SAVR volume: year 1, 32 vs 19; year 2, 48 vs 28; year 3, 82 vs 38; year 4, 118 vs 54; P < .001). In adjusted analysis, high hospital SAVR volume alone was not associated with better patient outcomes after TAVR. When hospital TAVR and SAVR volumes were jointly analyzed, patients treated in hospitals with high TAVR volume had lower 30-day mortality after TAVR (high TAVR and low SAVR vs low TAVR and low SAVR: odds ratio, 0.85; 95% CI, 0.72-0.99; high TAVR and high SAVR vs low TAVR and high SAVR: odds ratio, 0.81; 95% CI, 0.69-0.95), the effect of which was more pronounced when hospitals also had high SAVR volume. Patients treated in hospitals with high SAVR volume and high TAVR volume had the lowest 30-day mortality (vs hospitals with low SAVR volume and TAVR volume: odds ratio, 0.77; 95% CI, 0.66-0.89).Conclusions and relevanceHospitals with high SAVR volume are most likely to be fast adopters of TAVR. Hospital SAVR volume alone is not associated with better TAVR outcomes. Accumulating high volumes of TAVR is associated with lower mortality after TAVR, particularly when hospitals have high SAVR volumes. Hospitals with high caseloads of both SAVR and TAVR are likely to achieve the best outcomes.
| S-EPMC6583695 | biostudies-literature
Project description:ObjectivesTo compare the outcomes after surgical (SAVR) and transcatheter aortic valve replacement (TAVR) for severe stenosis of bicuspid aortic valve (BAV).MethodsWe evaluated the early and mid-term outcome of patients with stenotic BAV who underwent SAVR or TAVR for aortic stenosis from the nationwide FinnValve registry.ResultsThe FinnValve registry included 6463 AS patients and 1023 (15.8%) of them had BAV. SAVR was performed in 920 patients and TAVR in 103 patients with BAV. In the overall series, device success after TAVR was comparable to SAVR (94.2% vs. 97.1%, p = 0.115). TAVR was associated with increased rate of mild-to-severe paravalvular regurgitation (PVR) (19.4% vs. 7.9%, p < 0.0001) and of moderate-to-severe PVR (2.9% vs. 0.7%, p = 0.053). When newer-generation TAVR devices were evaluated, mild-to-severe PVR (11.9% vs. 7.9%, p = 0.223) and moderate-to-severe PVR (0% vs. 0.7%, p = 1.000) were comparable to SAVR. Type 1 N-L and type 2 L-R/R-N were the BAV morphologies with higher incidence of mild-to-severe PVR (37.5% and 100%, adjusted for new-generation prostheses p = 0.025) compared to other types of BAVs. Among 75 propensity score-matched cohorts, 30-day mortality was 1.3% after TAVR and 5.3% after SAVR (p = 0.375), and 2-year mortality was 9.7% after TAVR and 18.7% after SAVR (p = 0.268) CONCLUSIONS: In patients with stenotic BAV, TAVR seems to achieve early and mid-term results comparable to SAVR. Type 1 N-L and type 2 L-R/R-N BAV morphologies had higher incidence of PVR. Larger studies evaluating different phenotypes of BAV are needed to confirm these findings.Clinical trial registrationClinicalTrials.gov Identifier: NCT03385915.
| S-EPMC7907039 | biostudies-literature
Project description:Although the results of the early TAVI experience are promising, longer-term follow-up is necessary before the procedure can be extended to lowerrisk patients. Many issues are not yet resolved, including the long-term effects of paravalvular leaks (which occur in most TAVI patients), the true stroke rate in TAVI patients (which is probably in the range of 5% to 6%), and the need for permanent pacemaker implantation (which ranges from 5% to 40% in TAVI patients, depending upon the device used). As the procedure is extended into the lower-risk population, these issues will assume greater import than they have in the population currently in treatment—very elderly, high-risk patients with limited life expectancy. As in the coronary-revascularization paradigm of percutaneous coronary intervention versus coronary artery bypass grafting, there will be increasing adoption of the transcatheter approach. Just as the rumors of the demise of surgical bypass were premature, conventional AVR will continue to be the predominant technique for the treatment of aortic stenosis during at least the next decade. Although the percentage of patients treated by a transcatheter approach will continue to increase, regulatory and reimbursement factors are likely to be the primary determinants of the rate of adoption.
| S-EPMC3014148 | biostudies-other
Project description:An 80-year-old male underwent a transcatheter aortic valve implantation (TAVI) for severe senile aortic stenosis. Six weeks after the surgery, he was readmitted to our institution because of a high-grade fever. Transesophageal echocardiography revealed thickening of all three leaflets of the aortic prosthesis and mobile mass on the leaflet, and Streptococcus sanguis was identified from his blood culture. Therefore, he was diagnosed with prosthetic valve endocarditis (PVE) and received intensive intravenous antibiotic therapy. Because he did not respond to the pharmacological therapy, surgical aortic valve replacement (AVR) was indicated although it was considered a relatively high-risk procedure. Herein, we report on the successful surgical AVR in this patient using a pericardial valve after removal of the infected prosthetic valve, and discuss some issues related to this rare complication after TAVI. <Learning objective: Transcatheter aortic valve implantation (TAVI) is a highly effective procedure for patients with symptomatic severe aortic stenosis who are at high risk or deemed inoperable. Because it only requires limited surgical invasiveness, the risk of prosthetic valve endocarditis (PVE) after TAVI is thought to be low. However, PVE can occur even early after TAVI. We present our recent such case and discuss some issues related to this rare complication.>.
| S-EPMC6279805 | biostudies-other
Project description:BackgroundAtrioventricular conduction disturbance occurs in a significant number of patients undergoing transcatheter aortic valve replacement (TAVR). However, not all cases are ventricular pacing-dependent. Thus, we aimed to study the incidence, predictors, and outcomes of new ventricular pacing dependency (VpDep) after TAVR.MethodsWe prospectively analyzed 130 consecutive transfemoral TAVR cases performed in Ramathibodi Hospital between 2015 and 2020. Three patients with prior ventricular pacing-dependent on cardiac implantable electronic devices (CIEDs) were excluded. The endpoints were VpDep at 1 month and all-cause mortality at the follow-up period end in 2021. The effects of variables on VpDep and all-cause mortality were evaluated using multivariate binary logistic regression and Cox regression analyses, respectively. First-degree atrioventricular block (AVB) was considered severe when the PR interval was >300 ms.ResultsOf the 127 patients [mean age, 81.8 years; 62.2% females; 67.7% balloon-expandable (BE) device], 7 patients (5.5%) had CIEDs implanted before TAVR that were not ventricular pacing-dependent. TAVR was successfully performed in 126 (99.2%) patients. Periprocedural stroke, cardiac tamponade, and major bleeding occurred in 2 (1.6%), 4 (3.1%), and 4 (3.1%) patients, respectively. The VpDep incidence at 1 month was 7.9% (n=10) among all patients and 34.5% among those with CIEDs (n=29). VpDep was more likely to occur in patients with pre-existing right bundle branch block (RBBB) [odds ratio (OR), 21.38; 95% confidence interval (CI): 3.28-139.33; P=0.001] and severe 1st degree or Mobitz I AVB (OR, 14.79; 95% CI: 1.65-132.74; P=0.016). After a mean follow-up of 25.8 months [standard deviation (SD), 21.2 months], death from any cause occurred in 18 patients (14.2%). However, VpDep was not associated with an increased mortality.ConclusionsIn this real-world cohort, pre-existing conduction abnormalities were significantly associated with a higher risk of VpDep. Mortality was similar between patients with and without VpDep.
| S-EPMC10478017 | biostudies-literature
Project description:ObjectiveTo compare the outcomes of transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients with pure aortic insufficiency (PAI).BackgroundThe treatment of choice for patients with severe symptomatic PAI is SAVR. However, not all patients are candidates for surgery because of comorbidities or are deemed high risk for surgery. As a result, TAVR is being used as an off-label procedure in some patients with PAI.Patients and methodsWe analyzed the National Inpatient Sample database from January 1, 2016, to December 31, 2017, using the International Classification of Diseases, 10th Revision. Inclusion criteria were patients with aortic valve insufficiency undergoing either TAVR or SAVR. Patients with concomitant aortic stenosis, or history of infective endocarditis, and those below the age of 18 years were excluded.ResultsA total of 14,720 patients with PAI underwent valve replacement. Of those, 6.2% underwent TAVR. The TAVR group was significantly older (median age 78 years vs 64 years; P <.001). There was no evidence of a difference in in-hospital mortality between the 2 groups. However, after adjustment, patients in the TAVR group were associated with favorable outcomes in terms of acute kidney injury, cardiogenic shock, postoperative respiratory complications, and length of stay. On the other hand, those in the SAVR group were less likely to need permanent pacemakers.ConclusionThere was no evidence of a significant statistical difference in in-hospital mortality between patients with PAI treated by either SAVR or TAVR, both in unmatched and propensity-matched cohorts. TAVR could be considered for patients with PAI who are not candidates for surgery.
| S-EPMC8404150 | biostudies-literature
Project description:BackgroundAortic stenosis is the most common valvular heart disease in the United States. Transcatheter aortic valve replacement (TAVR) is increasingly being adopted as an alternative to surgical aortic valve replacement (SAVR). In an era of value-based payment reform, our objective was to better understand the economic impact of the use of TAVR and SAVR in the United States.Methods and resultsWe performed a retrospective cohort study of Medicare beneficiaries who underwent TAVR or SAVR between 2012 and 2015. Using claims from a 20% sample of national fee-for-service Medicare beneficiaries, we calculated episode payments for patients who underwent aortic valve replacement from 90 days before aortic valve replacement through 90 days after hospital discharge. Among 18 804 eligible patients, 6455 underwent TAVR (34.3%), and 12 349 underwent SAVR (65.7%). After adjustment for patient characteristics, episode payments for TAVR were ≈7% lower than for SAVR (TAVR, $55 545 [95% CI, $54 643-56 446] versus $59 467 [95% CI, $58 723-60 211]; P<0.001). Patients with TAVR had higher preprocedural payments, but lower payments during and after the index hospitalization for the procedure. Episode payments increased with increasing comorbidity score for patients undergoing TAVR or SAVR (rate ratio, 1.16 [95% CI, 1.15-1.17]; P<0.001); however, this association was stronger for SAVR (rate ratio, 1.18 [95% CI, 1.17-1.19]) than for TAVR (rate ratio, 1.11 [95% CI, 1.11-1.12]; P<0.001 for interaction). Thus, differences in episode payments between TAVR and SAVR were greatest for the sickest patients but much less in healthier patients.ConclusionsTAVR is associated with lower episode payments than SAVR. However, episode payments for TAVR are less influenced by patient comorbidity. Therefore, as TAVR is increasingly used in patients with better baseline health status, the economic advantages of TAVR relative to SAVR may diminish.
| S-EPMC7017968 | biostudies-literature
Project description:BackgroundRandomized trials support the use of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis in high- and intermediate-risk patients, but the generalizability of those results in clinical practice has been challenged.ObjectivesThe aim of this study was to determine the safety and effectiveness of TAVR versus surgical aortic valve replacement (SAVR), particularly in intermediate- and high-risk patients, in a nationally representative real-world cohort.MethodsUsing data from the Transcatheter Valve Therapy Registry and Society of Thoracic Surgeons National Database linked to Medicare administrative claims for follow-up, 9,464 propensity-matched intermediate- and high-risk (Society of Thoracic Surgeons Predicted Risk of Mortality score ≥3%) U.S. patients who underwent commercial TAVR or SAVR were examined. Death, stroke, and days alive and out of the hospital to 1 year were compared, as well as discharge home, with subgroup analyses by surgical risk, demographics, and comorbidities.ResultsIn a propensity-matched cohort (median age 82 years, 48% women, median Society of Thoracic Surgeons Predicted Risk of Mortality score 5.6%), TAVR and SAVR patients experienced no difference in 1-year rates of death (17.3% vs. 17.9%; hazard ratio: 0.93; 95% confidence interval [CI]: 0.83 to 1.04) and stroke (4.2% vs. 3.3%; hazard ratio: 1.18; 95% CI: 0.95 to 1.47), and no difference was observed in the proportion of days alive and out of the hospital to 1 year (rate ratio: 1.00; 95% CI: 0.98 to 1.02). However, TAVR patients were more likely to be discharged home after treatment (69.9% vs. 41.2%; odds ratio: 3.19; 95% CI: 2.84 to 3.58). Results were consistent across most subgroups, including among intermediate- and high-risk patients.ConclusionsAmong unselected intermediate- and high-risk patients, TAVR and SAVR resulted in similar rates of death, stroke, and DAOH to 1 year, but TAVR patients were more likely to be discharged home.
| S-EPMC5826727 | biostudies-literature