Transcatheter heart valve selection and permanent pacemaker implantation in patients with pre-existent right bundle branch block

Background-Right bundle branch block is an established predictor for new conduction disturbances and need for a permanent pacemaker (PPM) after transcatheter aortic valve replacement. The aim of the study was to evaluate the absolute rates of transcatheter aortic valve replacement related PPM implantations in patients with pre-existent right bundle branch block and categorize for different transcatheter heart valves. Methods and Results-We pooled data on 306 transcatheter aortic valve replacement patients from 4 high-volume centers in Europe and selected those with right bundle branch block at baseline without a previously implanted PPM. Logistic regression was used to evaluate whether PPM rate differed among transcatheter heart valves after adjustment for confounders. Mean age was 83±7 years and 63% were male. Median Society of Thoracic Surgeons score was 6.3 (interquartile range, 4.1-10.2). The following transcatheter valve designs were used: Medtronic CoreValve (n=130; Medtronic, Minneapolis, MN); Edwards Sapien XT (ES-XT; n=124) and Edwards Sapien 3 (ES-3; n=32; Edwards Lifesciences, Irvine, CA); and Boston Scientific Lotus (n=20; Boston Scientific Corporation, Marlborough, MA). Overall permanent pacemaker implantation rate post-transcatheter aortic valve replacement was 41%, and per valve design: 75% with Lotus, 46% with CoreValve, 32% with ES-XT, and 34% with ES-3. The indication for PPM implantation was total atrioventricular block in 98% of the cases. Lotus was associated with a higher PPM rate than all other valves. PPM rate did not differ between ES-XT and ES-3. Ventricular paced rhythm at 30-day and 1-year follow-up was present in 81% at 89%, respectively. Conclusions-Right bundle branch block at baseline is associated with a high incidence of PPM implantation for all transcatheter heart valves. PPM rate was highest for Lotus and lowest for ES-XT and ES-3. Pacemaker dependency remained high during followup

Intraoperative hypotension and delirium among older adults undergoing transcatheter aortic valve replacement

Background: Postoperative delirium (POD) is a frequently observed complication after transcatheter aortic valve replacement (TAVR). The effects of intraoperative hypotension (IOH) on POD occurrence are currently unclear. Methods: A retrospective observational cohort study of patients who underwent TAVR was conducted. We predefined IOH as area under the threshold (AUT) of five mean arterial blood pressures (MBP), varying from <100 to <60 mmHg. The AUT consisted of the combination of duration and depth under the MBP thresholds, expressed in mmHg*min. All MBP AUTs were computed based on the complete procedure, independent of procedural phase or duration. Results: This cohort included 675 patients who underwent TAVR under general anesthesia (n = 128, 19%) or procedural sedation (n = 547, 81%). Delirium occurred mostly during the first 2 days after TAVR, and was observed in n = 93 (14%) cases. Furthermore, 674, 672, 663, 630, and 518 patients had at least 1 min intraoperative MBP <100, <90, <80, <70, and <60 mmHg, respectively. Patients who developed POD had higher AUT based on all five MBP thresholds during TAVR. The penalized adjusted odds ratio varied between 1.08 (99% confidence interval [CI] 0.74–1.56) for the AUT based on MBP < 100 mmHg and OR 1.06 (99% CI 0.88–1.28) for the AUT based on MBP < 60 mmHg. Conclusions: Intraoperative hypotension is frequently observed during TAVR, but not independently associated with POD after TAVR. Other potential factors than intraoperative hypotension may explain the occurrence of delirium after TAVR

Role of novel predictive factors on clinical outcome after transcatheter aortic valve replacement

In Chapter 2 we investigated the incidence, predictors, and prognostic effect of delirium on outcome after TAVR. Interestingly, we observed that delirium occurs among 13.4% of patients undergoing TAVR, and more commonly among individuals after nontransfemoral TAVR. Moreover, delirium following TAVR was associated with longer hospital stay irrespective of periprocedural complication, and postoperative mortality after transfemoral TAVR access when adjusted for possible confounding factors. Chapter 3 we gave a comprehensive review and meta-analysis of the literature on the incidence of POD after TAVR. The pooled incidence of delirium after TAVR was 8.1%, more frequently among nontransfemoral access compared with transfemoral access (i.e., 21.4% vs. 7.2%, respectively). Interestingly, using a specific measure for classifying delirium such as Confusion Assessment Method, an even higher incidence rate of POD after TAVR was identifiable (i.e., 13.5%) (25). Interestingly, in Chapter 4 we observed an association between the number of cerebral DWI-lesions and POD after TAVR. Although cerebral DWI-lesions may affect the whole brain after TAVR, we observed more new DWI-lesions in the brain areas supplied by anterior cerebral artery among patients with delirium. Furthermore, delirium occurs commonly with other periprocedural complications after TAVR, therefore the true effect of cerebral DWI-lesions on delirium occurrence was unknown (32). In this chapter, after stratification of the data according to the presence of periprocedural complications (e.g., infection, cerebral ischemic stroke, paravalvular aortic regurgitation, cardiac conduction abnormalities, atrial fibrillation, vascular or bleeding complication), we observed more cerebral DWI-lesions in patients with POD after uncomplicated TAVR, suggesting a possible contribution of these lesions to the development of delirium after TAVR. In Chapter 5 we explored the effect of TAVR on early and mid-term cognition outcome after TAVR using comprehensive neurocognitive batteries. Overall, we observed an improvement in immediate recall memory at 4 months follow-up after TAVR. Interestingly, this change was more often seen among patients who had lower preprocedural cognitive scores as compared with patients with average cognitive scores at baseline. Future studies are required to investigate predictive factors of cognitive decline, and ways to improve the management of patients who develop cognitive decline during the follow-up after TAVR. In Chapter 6 and 7 we evaluated the prognostic effect of preprocedural body mass index and smoking status on outcomes after TAVR. In both studies, we observed paradoxical associations between these variables and mortality outcome after TAVR among patients undergoing TAVR. Since TAVR indications are expanding towards lower risk patients, larger and well-designed studies are needed to assess the effect of these variables on outcomes after TAVR

Role of novel predictive factors on clinical outcome after transcatheter aortic valve replacement

In Chapter 2 we investigated the incidence, predictors, and prognostic effect of delirium on outcome after TAVR. Interestingly, we observed that delirium occurs among 13.4% of patients undergoing TAVR, and more commonly among individuals after nontransfemoral TAVR. Moreover, delirium following TAVR was associated with longer hospital stay irrespective of periprocedural complication, and postoperative mortality after transfemoral TAVR access when adjusted for possible confounding factors. Chapter 3 we gave a comprehensive review and meta-analysis of the literature on the incidence of POD after TAVR. The pooled incidence of delirium after TAVR was 8.1%, more frequently among nontransfemoral access compared with transfemoral access (i.e., 21.4% vs. 7.2%, respectively). Interestingly, using a specific measure for classifying delirium such as Confusion Assessment Method, an even higher incidence rate of POD after TAVR was identifiable (i.e., 13.5%) (25). Interestingly, in Chapter 4 we observed an association between the number of cerebral DWI-lesions and POD after TAVR. Although cerebral DWI-lesions may affect the whole brain after TAVR, we observed more new DWI-lesions in the brain areas supplied by anterior cerebral artery among patients with delirium. Furthermore, delirium occurs commonly with other periprocedural complications after TAVR, therefore the true effect of cerebral DWI-lesions on delirium occurrence was unknown (32). In this chapter, after stratification of the data according to the presence of periprocedural complications (e.g., infection, cerebral ischemic stroke, paravalvular aortic regurgitation, cardiac conduction abnormalities, atrial fibrillation, vascular or bleeding complication), we observed more cerebral DWI-lesions in patients with POD after uncomplicated TAVR, suggesting a possible contribution of these lesions to the development of delirium after TAVR. In Chapter 5 we explored the effect of TAVR on early and mid-term cognition outcome after TAVR using comprehensive neurocognitive batteries. Overall, we observed an improvement in immediate recall memory at 4 months follow-up after TAVR. Interestingly, this change was more often seen among patients who had lower preprocedural cognitive scores as compared with patients with average cognitive scores at baseline. Future studies are required to investigate predictive factors of cognitive decline, and ways to improve the management of patients who develop cognitive decline during the follow-up after TAVR. In Chapter 6 and 7 we evaluated the prognostic effect of preprocedural body mass index and smoking status on outcomes after TAVR. In both studies, we observed paradoxical associations between these variables and mortality outcome after TAVR among patients undergoing TAVR. Since TAVR indications are expanding towards lower risk patients, larger and well-designed studies are needed to assess the effect of these variables on outcomes after TAVR

Transcatheter aortic valve implantation with the new balloon-expandable sapien 3 versus sapien XT valve system

BACKGROUND: The new balloon-expandable Sapien 3 transcatheter heart valve (S3-THV) incorporates new features to reduce aortic regurgitation (AR) and vascular complications in transcatheter aortic valve implantation. Aim of this study is to compare the outcomes of the S3-THV with the preceding Sapien XT THV (SXT-THV) in patients who underwent transcatheter aortic valve implantation for symptomatic severe native aortic stenosis. METHODS AND RESULTS: Eligible patients were retrospectively identified in our institutional database and periprocedural clinical and imaging data were collected. Non-parsimonious one-to-many propensity score matching was performed to account for differences in baseline characteristics. Between November 2011 and December 2014, 167 patients underwent balloon-expandable transcatheter aortic valve implantation with either the S3-THV (n=49) or SXT-THV (n=118). Forty-four (89.8%) S3-THV patients were matched to 66 (55.9%) SXT-THV patients (mean age 80.3±8.4 and 80.5±7.8 years, median EuroSCORE 15.8 and 16.5%, respectively). In the S3-THV and SXT-THV groups, transfemoral approach (77.3% versus 78.8%) and postdilatation rates (15.9% versus 12.1%) were similar. Predischarge echocardiography demonstrated a lower incidence of ≥mild AR (15.9% versus 46.2%, P=0.003) for the S3-THV, despite reduced annulus area to prosthesis oversizing (8.2±5.1 versus 18.2±10.7%, P=0.001). Transfemoral access site-related life-threatening or major bleedings and vascular complications were absent in the S3-THV group (0% versus 7.7%, P=0.15). No differences were observed in pacemaker implantation rate (9.8% versus 8.8%, P=0.94) and 30-day mortality (both 5%). CONCLUSIONS: In this retrospective, propensity score-matched analysis, the S3-THV performed superiorly to the SXT-THV, as demonstrated by improved valve patency and increased transfemoral access safety

Transcatheter aortic valve implantation with the new balloon-expandable sapien 3 versus sapien XT valve system

BACKGROUND: The new balloon-expandable Sapien 3 transcatheter heart valve (S3-THV) incorporates new features to reduce aortic regurgitation (AR) and vascular complications in transcatheter aortic valve implantation. Aim of this study is to compare the outcomes of the S3-THV with the preceding Sapien XT THV (SXT-THV) in patients who underwent transcatheter aortic valve implantation for symptomatic severe native aortic stenosis. METHODS AND RESULTS: Eligible patients were retrospectively identified in our institutional database and periprocedural clinical and imaging data were collected. Non-parsimonious one-to-many propensity score matching was performed to account for differences in baseline characteristics. Between November 2011 and December 2014, 167 patients underwent balloon-expandable transcatheter aortic valve implantation with either the S3-THV (n=49) or SXT-THV (n=118). Forty-four (89.8%) S3-THV patients were matched to 66 (55.9%) SXT-THV patients (mean age 80.3±8.4 and 80.5±7.8 years, median EuroSCORE 15.8 and 16.5%, respectively). In the S3-THV and SXT-THV groups, transfemoral approach (77.3% versus 78.8%) and postdilatation rates (15.9% versus 12.1%) were similar. Predischarge echocardiography demonstrated a lower incidence of ≥mild AR (15.9% versus 46.2%, P=0.003) for the S3-THV, despite reduced annulus area to prosthesis oversizing (8.2±5.1 versus 18.2±10.7%, P=0.001). Transfemoral access site-related life-threatening or major bleedings and vascular complications were absent in the S3-THV group (0% versus 7.7%, P=0.15). No differences were observed in pacemaker implantation rate (9.8% versus 8.8%, P=0.94) and 30-day mortality (both 5%). CONCLUSIONS: In this retrospective, propensity score-matched analysis, the S3-THV performed superiorly to the SXT-THV, as demonstrated by improved valve patency and increased transfemoral access safety