Faculty Bibliography

OBJECTIVES/OBJECTIVE:This study sought to characterize the patients receiving post-implantation balloon dilation (PD) following transcatheter aortic valve replacement (TAVR) and evaluate procedural outcomes in the PARTNER (Placement of Aortic Transcatheter Valve) I trial. BACKGROUND:Following TAVR, PD has been used to treat paravalvular regurgitation. METHODS:The PARTNER I trial cohort A (n = 304) and cohort B (n = 194) patients randomized to TAVR and the nonrandomized continued access TAVR (n = 1,637) patients were included in the analysis. PD was performed at the discretion of the operator. Clinical events and echocardiographic variables were collected prospectively out to 1 year. RESULTS:The overall incidence of PD was 12.4%. PD patients had significantly less prosthesis-patient mismatch (p < 0.001) and larger effective orifice areas (p < 0.001) throughout the follow-up period. There were significantly more subacute strokes (occurring <7 days: 4.9% vs. 2.6%; p = 0.04) in PD patients but no difference in late stroke, either at 7 to 30 days (0.0% vs. 0.8%; p = 0.16) or >30 days (1.9 vs. 1.7%; p = 0.75). Although there was no significant increase in early mortality with PD, at 1 year, there was a trend for higher all-cause mortality (p = 0.054) and a significant difference in death or stroke (p = 0.04). When the subgroup of patients with none/trace paravalvular regurgitation were evaluated, there was no significant association of PD with mortality (p = 0.61) and death or stroke (p = 0.96). Multivariable analysis failed to show a relationship between PD and mortality. CONCLUSIONS:PD is associated with reduced rates of moderate or severe prosthesis-patient mismatch with no evidence for short-term structural deterioration of the balloon-expandable transcatheter valve. Although PD is associated with a greater incidence of early stroke, there is no significant association between PD and stroke beyond 7 days. Multivariable analysis shows no significant association between PD and mortality.

BACKGROUND:The Placement of Aortic Transcatheter Valves (PARTNER) trial reported a reduced rate of mortality in patients with previous coronary bypass grafting (CABG) operation who received surgical aortic valve replacement (SAVR) in comparison with transcatheter aortic valve replacement (TAVR). We sought to further evaluate these groups. METHODS:We reviewed the database of the 699 patients enrolled in the PARTNER trial. The cohort for this study consisted of 288 patients (41.2%) who had a history of CABG operation before enrollment in the PARTNER trial. All patients were followed up for 2 years. RESULTS:The mean age was 81.5±6.6 years, and 231 patients (80.2%) were men. The preoperative characteristics were similar in 140 patients (48.6%) who received SAVR and 148 (51.4%) who received TAVR. There were no differences between the two groups with respect to the operative outcomes of death, stroke, and myocardial infarction, but the TAVR patients experienced more paravalvular regurgitation (p<0.0001). At 2 years, there was a trend toward greater all-cause mortality in the TAVR patients (hazard ratio [HR] 1.53; 95% confidence interval [CI]: 0.99, 2.35; p=0.052). Furthermore, the TAVR patients had more repeated hospitalization (HR 1.75; 95% CI: 0.99, 3.07; p=0.05), death of any cause or repeated hospitalization (HR 1.52; 95% CI: 1.06, 2.19; p=0.02), and death of any cause or stroke (HR 1.51; 95% CI: 1.00, 2.27; p=0.05). CONCLUSIONS:The 2-year follow-up of patients with a history of previous CABG operation in the PARTNER trial demonstrated improved outcomes with SAVR in comparison with TAVR. Further longitudinal assessment is necessary to corroborate these findings and to understand the possible causes.

AIMS: Cardiac conduction disturbances, including a left bundle branch block (LBBB), occur frequently following transcatheter aortic valve replacement (TAVR) and may be associated with adverse clinical events. This analysis examines the incidence and implications of new onset, persistent LBBB in patients undergoing TAVR with a balloon-expandable valve. METHODS AND RESULTS: Patients undergoing TAVR in the Placement of Aortic Transcatheter Valves (PARTNER) trial and continued access registries with baseline and discharge/7-day electrocardiograms were included. Prior permanent pacemaker implantation (PPI) and baseline intraventricular conduction abnormalities were exclusion criteria. Predictors of new LBBB were identified and outcomes compared between patients with and without new LBBB. New LBBB occurred in 121 of 1151 (10.5%) patients and persisted in more than half at 6 months to 1 year. The only predictor of new LBBB was prior coronary artery bypass grafting. New LBBB was not associated with significant differences in 1-year mortality, cardiovascular mortality, repeat hospitalization, stroke, or myocardial infarction. However, it was associated with increased PPI during hospitalization (8.3 vs 2.8%, P = 0.005) and from discharge to 1 year (4.7 vs. 1.5%, P = 0.01). The ejection fraction failed to improve after TAVR in patients with new LBBB and remained lower at 6 months to 1 year (52.8 vs. 58.1%, P < 0.001). CONCLUSION: Persistent, new-onset LBBB occurred in 10.5% of patients without intraventricular baseline conduction who underwent TAVR in the PARTNER experience. New LBBB was not associated with death, repeat hospitalization, stroke, or myocardial infarction at 1 year, but was associated with a higher rate of PPI and failure of left ventricular ejection fraction to improve.

OBJECTIVES/OBJECTIVE:This study sought to examine sex-specific differences in outcomes after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) in high-risk patients with severe aortic stenosis. BACKGROUND:The PARTNER (Placement of Aortic Transcatheter Valve) trial demonstrated similar 2-year survival with SAVR or TAVR for high-risk patients, but sex-specific outcomes are unknown. METHODS:In all, 699 patients (300 female) were randomly assigned 1:1 to either SAVR or TAVR with a balloon expandable pericardial tissue valve. Baseline characteristics and 2-year outcomes of TAVR versus SAVR were compared among males and females. RESULTS:Baseline characteristics differed between the sexes. Despite higher Society of Thoracic Surgeons mortality risk scores (11.9 vs. 11.6; p = 0.05), female patients had lower prevalence of coronary artery disease (64.4% vs. 83.7%), prior coronary artery bypass graft surgery (19.8% vs. 61.2%), peripheral vascular disease (36.4% vs. 46.9%), diabetes mellitus (35.6% vs. 45.6%), and elevated creatinine (11.7% vs. 23.9%). Among female patients, procedural mortality trended lower with TAVR versus SAVR (6.8% vs. 13.1%; p = 0.07) and was maintained throughout follow-up (hazard ratio [HR]: 0.67; 95% confidence interval [CI]: 0.44 to 1.00; p = 0.049), driven by the transfemoral arm (HR: 0.55; 95% CI: 0.32 to 0.93; p = 0.02). Among male patients, although procedural mortality was lower with TAVR (6% vs. 12.1%; p = 0.03), there was no overall survival benefit (HR: 1.15; 95% CI: 0.82 to 1.61; p = 0.42). CONCLUSIONS:In this retrospective subanalysis of high-risk, symptomatic aortic stenosis patients in the PARTNER trial, female subjects had lower late mortality with TAVR versus SAVR. This was especially true among patients suitable for transfemoral access and suggests that TAVR may be preferred over surgery for high-risk female patients. A randomized, controlled trial conducted specifically in female patients is necessary to properly study differences in mortality between treatment modalities. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

OBJECTIVES: This study sought to identify the incidence, predictors, and prognostic impact of bleeding complications (BC) after surgical aortic valve replacement (SAVR) compared with transcatheter aortic valve replacement (TAVR). BACKGROUND: Bleeding complications after SAVR and TAVR are frequent and may be associated with an unfavorable prognosis. METHODS: In the randomized controlled PARTNER (Placement of Aortic Transcatheter Valve) I trial, 657 patients from cohort A (operable high risk) were randomly assigned to SAVR or TAVR (transfemoral [TF] if iliofemoral access was suitable or transapical [TA] if not) and received the designated treatment. First-generation Edwards SAPIEN valves and delivery systems (Edwards Lifesciences, Irvine, California) were used for TAVR, through a 22- or 24-F sheath. The 30-day rates of major BC (modified Valve Academic Research Consortium definitions), predictors of BC, and their association with 1-year mortality were assessed. RESULTS: A total of 71 (22.7%), 27 (11.3%), and 9 (8.8%) patients had major BC within 30 days of the procedure after SAVR, TF-TAVR, and TA-TAVR, respectively (p < 0.0001). SAVR was associated with a significantly higher 30-day rate of transfusion (17.9%) than either TF-TAVR (7.1%) or TA-TAVR (4.8%; p < 0.0001). Independent predictors of major BC were the occurrence of major vascular complications and use of intraprocedural hemodynamic support among TF-TAVR patients, severe procedural complications requiring conversion to open surgery among TA-TAVR patients, and the presence of low hemoglobin at baseline among SAVR patients. Major BC was identified as the strongest independent predictor of 1-year mortality among the full cohort. However, risk-adjusted analyses demonstrated a significant interaction between BC and treatment strategy with respect to mortality, suggesting that BC after SAVR have a greater impact on prognosis than after TAVR. CONCLUSIONS: Among high-risk aortic stenosis patients enrolled in the PARTNER I randomized trial, BC were more common after SAVR than after TAVR and were also associated with a worse long-term prognosis. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

OBJECTIVES: The goal of this study was to examine the impact of reasons for surgical inoperability on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Patients with severe aortic stenosis may be deemed inoperable due to technical or clinical reasons. The relative impact of each designation on early and late outcomes after TAVR is unclear. METHODS: Patients were studied from the inoperable arm (cohort B) of the randomized PARTNER (Placement of Aortic Transcatheter Valve) trial and the nonrandomized continued access registry. Patients were classified according to whether they were classified as technically inoperable (TI) or clinically inoperable (CLI). Reasons for TI included porcelain aorta, previous mediastinal radiation, chest wall deformity, and potential for injury to previous bypass graft on sternal re-entry. Reasons for CLI were systemic factors that were deemed to make survival unlikely. RESULTS: Of the 369 patients, 23.0% were considered inoperable for technical reasons alone; the remaining were judged to be CLI. For TI, the most common cause was a porcelain aorta (42%); for CLI, it was multiple comorbidities (48%) and frailty (31%). Quality of life and 2-year mortality were significantly better among TI patients compared with CLI patients (mortality 23.3% vs. 43.8%; p < 0.001). Nonetheless, TAVR led to substantial survival benefits compared with standard therapy in both inoperable cohorts. CONCLUSIONS: Patients undergoing TAVR based solely on TI have better survival and quality of life improvements than those who are inoperable due to clinical comorbidities. Both TI and CLI TAVR have significant survival benefit in the context of standard therapy. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).

BACKGROUND: Previous studies have shown cross-sectional 3-dimensional (3D) transesophageal echocardiographic (TEE) measurements to severely underestimate multidetector row computed tomographic (MDCT) measurements for the assessment of aortic annulus before transcatheter aortic valve replacement. This study compares annulus measurements from 3D-TEE using off-label use of commercially available software with MDCT measurements and assesses their ability to predict paravalvular regurgitation. METHODS AND RESULTS: One hundred patients with severe, symptomatic aortic stenosis who had both contrast MDCT and 3D-TEE for annulus assessment before balloon-expandable transcatheter aortic valve replacement were analyzed. Annulus area, perimeter, and orthogonal maximum and minimum diameters were measured. Receiver operating characteristic analysis was performed with mild or greater paravalvular regurgitation as the classification variable. Three-dimensional TEE and MDCT cross-sectional perimeter and area measurements were strongly correlated (r=0.93-0.94; P<0.0001); however, the small differences (/= mild paravalvular regurgitation was good for both MDCT (area under the curve for perimeter and area cover index=0.715 and 0.709, respectively) and 3D-TEE (area under the curve for perimeter and area cover index=0.709 and 0.694, respectively). Differences in receiver operating characteristic analysis between MDCT and 3D-TEE perimeter and area cover indexes were not statistically significant (P=0.15 and 0.35, respectively). CONCLUSIONS: Annulus measurements using a new method for analyzing 3D-TEE images closely approximate those of MDCT. Annulus measurements from both modalities predict mild or greater paravalvular regurgitation with equivalent accuracy.

The treatment of calcified coronary lesions by percutaneous coronary intervention has been shown to be associated with poor outcomes and an increased rate of complications. However, the impact of coronary calcification in patients undergoing coronary artery bypass grafting (CABG) is unknown. A total of 755 patients presenting with acute coronary syndrome in the Acute Catheterization and Urgent Intervention Triage Strategy trial underwent CABG. Patients were divided into 3 groups according to the presence and extent of coronary calcifications (lesion level: severe, moderate, none to mild) as assessed by an independent angiographic core laboratory. Major ischemic and bleeding outcomes were assessed at 30 days and 1 year. Severe calcification was found in 103 patients (13.6%), moderate calcification in 249 patients (33.0%), and none-to-mild calcification in 403 patients (53.4%). The presence of severe calcification compared with moderate or none to mild was associated with a significantly higher unadjusted rate of death (11.8% vs 3.7% vs 4.5%, p = 0.006), death or myocardial infarction (MI; 31.1% vs 19.7% vs 16.4%, p = 0.006), and major adverse cardiac event (MACE; 32.0% vs 22.6% vs 20.8%, p = 0.059) at 1 year. By multivariate analysis, severe calcification (vs nonsevere calcification) was identified as an independent predictor of 1-year MACE (hazard ratio 1.49, 95% confidence interval 1.01 to 2.21, p = 0.04) and death or MI (hazard ratio 1.77, 95% confidence interval 1.18 to 2.66, p = 0.006). In conclusion, the presence of severe coronary calcification was associated with worse outcomes after CABG, including an increased risk of death. The presence of severe coronary calcification was identified as an independent predictor of MACE and death or MI 1 year after CABG.