Marina Urena

The Impact of Integration of a Multidetector Computed Tomography Annulus Area Sizing Algorithm on Outcomes of Transcatheter Aortic Valve Replacement A Prospective, Multicenter, Controlled Trial

OBJECTIVES This study prospectively investigated the impact of integration of a multidetector computed tomography (MDCT) annular area sizing algorithm on transcatheter aortic valve replacement (TAVR) outcomes. BACKGROUND Appreciation of the 3-dimensional, noncircular geometry of the aortic annulus is important for transcatheter heart valve (THV) sizing. METHODS Patients being evaluated for TAVR in 4 centers underwent pre-procedural MDCT. Recommendations for balloon-expandable THV size selection were based on an MDCT sizing algorithm with an optimal goal of modest annulus area oversizing (5% to 10%). Consecutive patients who underwent TAVR with the algorithm (MDCT group) were compared with consecutive patients without the algorithm (control group). The primary endpoint was the incidence of more than mild paravalvular regurgitation (PAR), and the secondary endpoint was the composite of in-hospital death, aortic annulus rupture, and severe PAR. RESULTS Of 266 patients, 133 consecutive patients underwent TAVR (SAPIEN XT THV) in the MDCT group and 133 consecutive patients were in the control group. More than mild PAR was present in 5.3% (7 of 133) of the MDCT group and in 12.8% (17 of 133) in the control group (p = 0.032). The combined secondary endpoint occurred in 3.8% (5 of 133) of the MDCT group and in 11.3% (15 of 133) of the control group (p = 0.02), driven by the difference of severe PAR. CONCLUSIONS The implementation of an MDCT annulus area sizing algorithm for TAVR reduces PAR. Three-dimensional aortic annular assessment and annular area sizing should be considered for TAVR.

Timing, Predictive Factors, and Prognostic Value of Cerebrovascular Events in a Large Cohort of Patients Undergoing Transcatheter Aortic Valve Implantation

Background— The objective of this study was to evaluate the timing, predictive factors, and prognostic value of cerebrovascular events (CVEs) after transcatheter aortic valve implantation. Methods and Results— The study included 1061 consecutive patients who underwent transcatheter aortic valve implantation with a balloon-expandable (64%) or self-expandable (36%) valve. CVEs were classified as acute (⩽24 hours), subacute (1–30 days), or late (>30 days). CVEs occurred in 54 patients (5.1%; stroke, 4.2%) within 30 days after transcatheter aortic valve implantation (acute in 54% of cases). The predictors of acute CVEs were balloon postdilation of the valve prosthesis (odds ratio, 2.46; 95% confidence interval,1.07–5.67) and valve dislodgment/embolization (odds ratio, 4.36; 95% CI, 1.21–15.69); new-onset atrial fibrillation (odds ratio, 2.76; 95% CI, 1.11–6.83) was a predictor of subacute CVEs. Late CVEs occurred in 35 patients (3.3%; stroke, 2.1%) at a median follow-up of 12 months (3–23 months). The predictors of late CVEs were chronic atrial fibrillation (2.84; 95% CI, 1.46–5.53), peripheral vascular disease (hazard ratio, 2.02; 95% CI, 1.02–3.97), and prior cerebrovascular disease (hazard ratio, 2.04; 95% CI, 1.01–4.15). Major stroke was associated with 30-day (odds ratio, 7.43; 95% CI, 2.45–22.53) and late (hazard ratio, 1.75; 95% CI, 1.01–3.04) mortality. Conclusions— In a large cohort of patients undergoing transcatheter aortic valve implantation, the rates of acute and subacute CVEs were 2.7% and 2.4%, respectively. While balloon postdilation and valve dislodgment/embolization were the predictors of acute CVEs, new-onset atrial fibrillation determined a higher risk for subacute events. Late events were determined mainly by a history of chronic atrial fibrillation and peripheral and cerebrovascular disease. The occurrence of major stroke was associated with increased early and late mortality. These results provide important insights for the implementation of preventive measures for CVEs after transcatheter aortic valve implantation.

Predictive factors, management, and clinical outcomes of coronary obstruction following transcatheter aortic valve implantation: Insights from a large multicenter registry

OBJECTIVES This study sought to evaluate the main baseline and procedural characteristics, management, and clinical outcomes of patients from a large cohort of patients undergoing transcatheter aortic valve implantation (TAVI) who suffered coronary obstruction (CO). BACKGROUND Very little data exist on CO following TAVI. METHODS This multicenter registry included 44 patients who suffered symptomatic CO following TAVI of 6,688 patients (0.66%). Pre-TAVI computed tomography data was available in 28 CO patients and in a control group of 345 patients (comparisons were performed including all patients and a cohort matched 1:1 by age, sex, previous coronary artery bypass graft, transcatheter valve type, and size). RESULTS Baseline and procedural variables associated with CO were older age (p < 0.001), female sex (p < 0.001), no previous coronary artery bypass graft (p = 0.043), the use of a balloon-expandable valve (p = 0.023), and previous surgical aortic bioprosthesis (p = 0.045). The left coronary artery was the most commonly involved (88.6%). The mean left coronary artery ostia height and sinus of Valsalva diameters were lower in patients with obstruction than in control subjects (10.6 ± 2.1 mm vs. 13.4 ± 2.1 mm, p < 0.001; 28.1 ± 3.8 mm vs. 31.9 ± 4.1 mm, p < 0.001). Differences between groups remained significant after the case-matched analysis (p < 0.001 for coronary height; p = 0.01 for sinus of Valsalva diameter). Most patients presented with persistent severe hypotension (68.2%) and electrocardiographic changes (56.8%). Percutaneous coronary intervention was attempted in 75% of the cases and was successful in 81.8%. Thirty-day mortality was 40.9%. After a median follow-up of 12 (2 to 18) months, the cumulative mortality rate was 45.5%, and there were no cases of stent thrombosis or reintervention. CONCLUSIONS Symptomatic CO following TAVI was a rare but life-threatening complication that occurred more frequently in women, in patients receiving a balloon-expandable valve, and in those with a previous surgical bioprosthesis. Lower-lying coronary ostium and shallow sinus of Valsalva were associated anatomic factors, and despite successful treatment, acute and late mortality remained very high, highlighting the importance of anticipating and preventing the occurrence of this complication.

Percutaneous Left Atrial Appendage Closure With the AMPLATZER Cardiac Plug Device in Patients With Nonvalvular Atrial Fibrillation and Contraindications to Anticoagulation Therapy

OBJECTIVES The aim of this study was to evaluate the results associated with left atrial appendage closure (LAAC) with the AMPLATZER Cardiac Plug (ACP) (St. Jude Medical, Minneapolis, Minnesota) in patients with nonvalvular atrial fibrillation and absolute contraindications to anticoagulation therapy. BACKGROUND Few data exist on the late outcomes after LAAC in patients with absolute contraindications to warfarin. METHODS A total of 52 patients with nonvalvular atrial fibrillation underwent LAAC with the ACP device in 7 Canadian centers. Most patients received short-term (1 to 3 months) dual-antiplatelet therapy after the procedure and single-antiplatelet therapy thereafter. A transesophageal echocardiography was performed in 74% of patients at the 6-month follow-up. No patient was lost to follow-up (≥ 12 months in all patients). RESULTS The mean age and median (interquartile range) CHADS2 score were 74 ± 8 years and 3 (2 to 4), respectively. The procedure was successful in 98.1% of the patients, and the main complications were device embolization (1.9%) and pericardial effusion (1.9%), with no cases of periprocedural stroke. At a mean follow-up of 20 ± 5 months, the rates of death, stroke, systemic embolism, pericardial effusion, and major bleeding were 5.8%, 1.9%, 0%, 1.9%, and 1.9%, respectively. The presence of mild peridevice leak was observed in 16.2% of patients at the 6-month follow-up as evaluated by transesophageal echocardiography. There were no cases of device thrombosis. CONCLUSIONS In patients with nonvalvular atrial fibrillation at high risk of cardioembolic events and absolute contraindications to anticoagulation, LAAC using the ACP device followed by dual-/single-antiplatelet therapy was associated with a low rate of embolic and bleeding events after a mean follow-up of 20 months. No cases of severe residual leak or device thrombosis were observed at the 6-month follow-up.

Incidence, predictive factors, and prognostic value of new-onset atrial fibrillation following transcatheter aortic valve implantation.

OBJECTIVES This study sought to evaluate the incidence, predictive factors, and prognostic value of new-onset atrial fibrillation (NOAF) following transcatheter aortic valve implantation (TAVI). BACKGROUND Very few data exist on the occurrence of NOAF following TAVI. METHODS A total of 138 consecutive patients with no prior history of atrial fibrillation (AF) underwent TAVI with a balloon-expandable valve. Patients were on continuous electrocardiogram monitoring until hospital discharge, and NOAF was defined as any episode of AF lasting >30 s. All clinical, echocardiographic, procedural, and follow-up data were prospectively collected. RESULTS NOAF occurred in 44 patients (31.9%) at a median time of 48 h (interquartile range: 0 to 72 h) following TAVI. The predictive factors of NOAF were left atrial (LA) size (odds ratio [OR]: 1.21 for each increase in 1 mm/m(2), 95% confidence interval [CI]: 1.09 to 1.34, p < 0.0001) and transapical approach (OR: 4.08, 95% CI: 1.35 to 12.31, p = 0.019). At 30-day follow-up, NOAF was associated with a higher rate of stroke/systemic embolism (13.6% vs. 3.2%, p = 0.021, p = 0.047 after adjustment for baseline differences between groups), with no differences in mortality rate between groups (NOAF: 9.1%, no-NOAF: 6.4%, p = 0.57). At a median follow-up of 12 months (interquartile range: 5 to 20 months), a total of 27 patients (19.6%) had died, with no differences between the NOAF (15.9%) and no-NOAF (21.3%) groups, p = 0.58. The cumulative rate of stroke and stroke/systemic embolism at follow-up were 13.6% and 15.9%, respectively, in the NOAF group versus 3.2% in the no-NOAF group (p = 0.039, adjusted p = 0.037 for stroke; p = 0.020, adjusted p = 0.023 for stroke/systemic embolism). CONCLUSIONS NOAF occurred in about one-third of the patients with no prior history of AF undergoing TAVI and its incidence was increased in patients with larger LA size and those undergoing transapical TAVI. NOAF was associated with a higher rate of stroke/systemic embolism, but not a higher mortality, at 30 days and at 1-year follow-up.

Predictive factors and long-term clinical consequences of persistent left bundle branch block following transcatheter aortic valve implantation with a balloon-expandable valve

OBJECTIVES This study evaluated the predictive factors and prognostic value of new-onset persistent left bundle branch block (LBBB) in patients undergoing transcatheter aortic valve implantation (TAVI) with a balloon-expandable valve. BACKGROUND The predictors of persistent (vs. transient or absent) LBBB after TAVI with a balloon-expandable valve and its clinical consequences are unknown. METHODS A total of 202 consecutive patients with no baseline ventricular conduction disturbances or previous permanent pacemaker implantation (PPI) who underwent TAVI with a balloon-expandable valve were included. Patients were on continuous electrocardiographic (ECG) monitoring during hospitalization and 12-lead ECG was performed daily until hospital discharge. No patient was lost at a median follow-up of 12 (range: 6 to 24) months, and ECG tracing was available in 97% of patients. The criteria for PPI were limited to the occurrence of high-degree atrioventricular block (AVB) or severe symptomatic bradycardia. RESULTS New-onset LBBB was observed in 61 patients (30.2%) after TAVI, and had resolved in 37.7% and 57.3% at hospital discharge and 6- to 12-month follow-up, respectively. Baseline QRS duration (p = 0.037) and ventricular depth of the prosthesis (p = 0.017) were independent predictors of persistent LBBB. Persistent LBBB at hospital discharge was associated with a decrease in left ventricular ejection fraction (p = 0.001) and poorer functional status (p = 0.034) at 1-year follow-up. Patients with persistent LBBB and no PPI at hospital discharge had a higher incidence of syncope (16.0% vs. 0.7%; p = 0.001) and complete AVB requiring PPI (20.0% vs. 0.7%; p < 0.001), but not of global mortality or cardiac mortality during the follow-up period (all, p > 0.20). New-onset LBBB was the only factor associated with PPI following TAVI (p < 0.001). CONCLUSIONS Up to 30% of patients with no prior conduction disturbances developed new LBBB following TAVI with a balloon-expandable valve, although it was transient in more than one third. Longer baseline QRS duration and a more ventricular positioning of the prosthesis were associated with a higher rate of persistent LBBB, which in turn determined higher risks for complete AVB and PPI, but not mortality, at 1-year follow-up.

Predictive factors, efficacy, and safety of balloon post-dilation after transcatheter aortic valve implantation with a balloon-expandable valve

OBJECTIVES This study sought to evaluate the predictive factors, effects, and safety of balloon post-dilation (BPD) for the treatment of significant paravalvular aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI). BACKGROUND Very few data exist on BPD after TAVI with a balloon-expandable valve. METHODS A total of 211 patients who underwent TAVI with a balloon-expandable valve were included. BPD was performed after TAVI if paravalvular AR ≥ 2 was identified by transesophageal echocardiography. Clinical events and echocardiographic data were prospectively recorded, and median follow-up was 12 (6 to 24) months. RESULTS BPD was performed in 59 patients (28%), leading to a reduction in at least 1 degree of AR in 71% of patients, with residual AR <2 in 54% of the patients. The predictors of the need for BPD were the degree of valve calcification and transfemoral approach, with valve calcification volume >2,200 and >3,800 mm(3) best determining the need for and a poor response to BPD, respectively. Patients who underwent BPD had a higher incidence of cerebrovascular events at 30 days (11.9% vs. 2.0%, p = 0.006), with most (83%) events within the 24 h after the procedure occurring in patients who had BPD. No significant changes in valve area or AR degree were observed at follow-up in BPD and no-BPD groups. CONCLUSIONS BPD was needed in about one-fourth of the patients undergoing TAVI with a balloon-expandable valve and was successful in about one-half of them. A higher degree of valve calcification and transfemoral approach predicted the need for BPD. BPD was not associated with any deleterious effect on valve function at mid-term follow-up, but a higher rate of cerebrovascular events was observed in patients who had BPD.

Impact of Low Flow on the Outcome of High-Risk Patients Undergoing Transcatheter Aortic Valve Replacement

OBJECTIVES This study sought to assess the impact of baseline left ventricular (LV) outflow, LV ejection fraction (LVEF), and transvalvular gradient on outcomes following transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis (AS). BACKGROUND Low flow (i.e., reduced stroke volume index [SVi]) can occur with both reduced and preserved LVEF. Low flow is often associated with low gradient despite severe stenosis and with worse outcomes following surgical aortic valve replacement. However, there are few data about the impact of low flow on outcomes following TAVR. METHODS We retrospectively analyzed the clinical, Doppler-echocardiographic, and outcome data prospectively collected in 639 patients who underwent TAVR for symptomatic severe AS in 2 Canadian centers. RESULTS In this cohort, 334 (52.3%) patients had a low flow (SVi <35 ml/m(2)) and these patients had increased 30-day mortality (11.4 vs. 5.9%, p = 0.01), 2-year all-cause mortality (35.3 vs. 30.9%, p = 0.005), and 2-year cardiovascular mortality (25.7 vs. 16.8%, p = 0.01) compared with patients with normal flow. Reduced flow was an independent predictor of 30-day mortality (odds ratio: 1.94, p = 0.026), cumulative all-cause mortality (hazard ratio: 1.27 per 10 ml/m(2) SVi decrease, p = 0.016), and cumulative cardiovascular mortality (hazard ratio: 1.29 per 10 ml/m(2) decrease, p = 0.04). Despite significant association in univariable analyses, low LVEF and low mean gradient were not found to be independent predictors of outcomes in multivariable analyses. CONCLUSIONS Low flow but not low LVEF or low gradient is an independent predictor of early and late mortality following TAVR in high-risk patients with severe AS. SVi should be integrated in the risk stratification process of these patients.

Coronary obstruction following transcatheter aortic valve implantation: a systematic review.

OBJECTIVES This study sought to evaluate, through a systematic review of the published data, the main baseline characteristics, management, and clinical outcomes of patients suffering coronary obstruction as a complication of transcatheter aortic valve implantation (TAVI). BACKGROUND Very few data exist on coronary obstruction after TAVI. METHODS Studies published between 2002 and 2012, with regard to coronary obstruction as a complication of TAVI, were identified with a systematic electronic search. Only the studies reporting data on the main baseline and procedural characteristics, management of the complication, and clinical outcomes were analyzed. RESULTS A total of 18 publications describing 24 patients were identified. Most (83%) patients were women, with a mean age of 83 ± 7 years and a mean logistic European System for Cardiac Operative Risk Evaluation score of 25.1 ± 12.0%. Mean left coronary artery (LCA) ostium height and aortic root width were 10.3 ± 1.6 mm and 27.8 ± 2.8 mm, respectively. Most patients (88%) had received a balloon-expandable valve, and coronary obstruction occurred more frequently in the LCA (88%). Percutaneous coronary intervention was attempted in 23 cases (95.8%) and was successful in all but 2 patients (91.3%). At 30-day follow-up, there were no cases of stent thrombosis or repeat revascularization, and the mortality rate was 8.3%. CONCLUSIONS Reported cases of coronary obstruction after TAVI occurred more frequently in women, in patients receiving a balloon-expandable valve, and the LCA was the most commonly involved artery. Percutaneous coronary intervention was a feasible and successful treatment in most cases. Continuous efforts should be made to identify the factors associated with this life-threatening complication to implement the appropriate measures for its prevention.

Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation

Background— Very few data exist on the clinical impact of permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation. The objective of this study was to assess the impact of PPI after transcatheter aortic valve implantation on late outcomes in a large cohort of patients. Methods and Results— A total of 1556 consecutive patients without prior PPI undergoing transcatheter aortic valve implantation were included. Of them, 239 patients (15.4%) required a PPI within the first 30 days after transcatheter aortic valve implantation. At a mean follow-up of 22±17 months, no association was observed between the need for 30-day PPI and all-cause mortality (hazard ratio, 0.98; 95% confidence interval, 0.74–1.30; P=0.871), cardiovascular mortality (hazard ratio, 0.81; 95% confidence interval, 0.56–1.17; P=0.270), and all-cause mortality or rehospitalization for heart failure (hazard ratio, 1.00; 95% confidence interval, 0.77–1.30; P=0.980). A lower rate of unexpected (sudden or unknown) death was observed in patients with PPI (hazard ratio, 0.31; 95% confidence interval, 0.11–0.85; P=0.023). Patients with new PPI showed a poorer evolution of left ventricular ejection fraction over time (P=0.017), and new PPI was an independent predictor of left ventricular ejection fraction decrease at the 6- to 12-month follow-up (estimated coefficient, −2.26; 95% confidence interval, −4.07 to −0.44; P=0.013; R2=0.121). Conclusions— The need for PPI was a frequent complication of transcatheter aortic valve implantation, but it was not associated with any increase in overall or cardiovascular death or rehospitalization for heart failure after a mean follow-up of ≈2 years. Indeed, 30-day PPI was a protective factor for the occurrence of unexpected (sudden or unknown) death. However, new PPI did have a negative effect on left ventricular function over time.Background— Very few data exist on the clinical impact of permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation. The objective of this study was to assess the impact of PPI after transcatheter aortic valve implantation on late outcomes in a large cohort of patients. Methods and Results— A total of 1556 consecutive patients without prior PPI undergoing transcatheter aortic valve implantation were included. Of them, 239 patients (15.4%) required a PPI within the first 30 days after transcatheter aortic valve implantation. At a mean follow-up of 22±17 months, no association was observed between the need for 30-day PPI and all-cause mortality (hazard ratio, 0.98; 95% confidence interval, 0.74–1.30; P =0.871), cardiovascular mortality (hazard ratio, 0.81; 95% confidence interval, 0.56–1.17; P =0.270), and all-cause mortality or rehospitalization for heart failure (hazard ratio, 1.00; 95% confidence interval, 0.77–1.30; P =0.980). A lower rate of unexpected (sudden or unknown) death was observed in patients with PPI (hazard ratio, 0.31; 95% confidence interval, 0.11–0.85; P =0.023). Patients with new PPI showed a poorer evolution of left ventricular ejection fraction over time ( P =0.017), and new PPI was an independent predictor of left ventricular ejection fraction decrease at the 6- to 12-month follow-up (estimated coefficient, −2.26; 95% confidence interval, −4.07 to −0.44; P =0.013; R 2=0.121). Conclusions— The need for PPI was a frequent complication of transcatheter aortic valve implantation, but it was not associated with any increase in overall or cardiovascular death or rehospitalization for heart failure after a mean follow-up of ≈2 years. Indeed, 30-day PPI was a protective factor for the occurrence of unexpected (sudden or unknown) death. However, new PPI did have a negative effect on left ventricular function over time. # CLINICAL PERSPECTIVE {#article-title-43}