Ricardo Allende

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.

Comparison of hemodynamic performance of the balloon-expandable SAPIEN 3 versus SAPIEN XT transcatheter valve.

The SAPIEN 3 valve (S3V) is a new-generation transcatheter valve with enhanced anti-paravalvular leak properties, but no data comparing with earlier transcatheter valve systems are available. We aimed to compare the hemodynamic performance of the S3V and the SAPIEN XT valve (SXTV) in a case-matched study with echo core laboratory analysis. A total of 27 patients who underwent transcatheter aortic valve replacement (TAVR) with the S3V were matched for prosthesis size (26 mm), aortic annulus area, and mean diameter measured by computed tomography, left ventricular ejection fraction, body surface area, and body mass index with 50 patients treated with the SXTV. The prosthesis size was determined by oversizing of 1% to 15% of annulus area. Doppler echocardiographic images collected at baseline and 1-month follow-up were analyzed in a central echocardiography core laboratory. The need for postdilation was higher in the SXTV group (20% vs 4%, p=0.047), and mean residual gradient and effective orifice area were similar in both groups (p>0.05). The incidence of paravalvular aortic regurgitation was greater with the SXTV (≥mild: 42%, moderate: 8%) than with the S3V (≥mild: 7%, moderate: 0%; p=0.002 for ≥mild vs SXTV). The implantation of an S3V was the only factor associated with trace or no paravalvular leak after TAVR (p=0.007). In conclusion, TAVR with the S3V was associated with a very low rate of paravalvular leaks and need for balloon postdilation, much lower than that observed with the earlier generation of balloon-expandable valve (SXTV). The confirmation of these results in a larger cohort of patients will represent a major step forward in using transcatheter valves for the treatment of aortic stenosis.

Advanced chronic kidney disease in patients undergoing transcatheter aortic valve implantation: insights on clinical outcomes and prognostic markers from a large cohort of patients

AIM The aim of this study was to determine the effects of advanced chronic kidney disease (CKD) on early and late outcomes after transcatheter aortic valve implantation (TAVI), and to evaluate the predictive factors of poorer outcomes in such patients. METHODS AND RESULTS This was a multicentre study including a total of 2075 consecutive patients who had undergone TAVI. Patients were grouped according the estimated glomerular filtration rate as follows: CKD stage 1-2 (≥60 mL/min/1.73 m(2); n = 950), stage 3 (30-59 mL/min/1.73 m(2); n = 924), stage 4 (15-29 mL/min/1.73 m(2); n = 134) and stage 5 (<15 mL/min/1.73 m² or dialysis; n = 67). Clinical outcomes were evaluated at 30-days and at follow-up (median of 15 [6-29] months) and defined according to the VARC criteria. Advanced CKD (stage 4-5) was an independent predictor of 30-day major/life-threatening bleeding (P = 0.001) and mortality (P = 0.027), and late overall, cardiovascular and non-cardiovascular mortality (P < 0.01 for all). Pre-existing atrial fibrillation (HR: 2.29, 95% CI: 1.47-3.58, P = 0.001) and dialysis therapy (HR: 1.86, 95% CI: 1.17-2.97, P = 0.009) were the predictors of mortality in advanced CKD patients, with a mortality rate as high as 71% at 1-year follow-up in those patients with these 2 factors. Advanced CKD patients who had survived at 1-year follow-up exhibited both a significant improvement in NYHA class (P < 0.001) and no deterioration in valve hemodynamics (P = NS for changes in mean gradient and valve area over time). CONCLUSIONS Advanced CKD was associated with a higher rate of early and late mortality and bleeding events following TAVI, with AF and dialysis therapy determining a higher risk in these patients. The mortality rate of patients with both factors was unacceptably high and this should be taken into account in the clinical decision-making process in this challenging group of patients.

Significant Mitral Regurgitation Left Untreated at the Time of Aortic Valve Replacement: A Comprehensive Review of a Frequent Entity in the Transcatheter Aortic Valve Replacement Era

Significant mitral regurgitation (MR) is frequent in patients with severe aortic stenosis (AS). In these cases, concomitant mitral valve repair or replacement is usually performed at the time of surgical aortic valve replacement (SAVR). Transcatheter aortic valve replacement (TAVR) has recently been considered as an alternative for patients at high or prohibitive surgical risk. However, concomitant significant MR in this setting is typically left untreated. Moderate to severe MR after aortic valve replacement is therefore a relevant entity in the TAVR era. The purpose of this review is to present the current knowledge on the clinical impact and post-procedural evolution of concomitant significant MR in patients with severe AS who have undergone aortic valve replacement (SAVR and TAVR). This information could contribute to improving both the clinical decision-making process in and management of this challenging group of patients.

Cardiac magnetic resonance versus transthoracic echocardiography for the assessment and quantification of aortic regurgitation in patients undergoing transcatheter aortic valve implantation

Background The transthoracic echocardiographic (TTE) evaluation of the severity of residual aortic regurgitation (AR) following transcatheter aortic valve implantation (TAVI) has been controversial and lacks validation. Objectives This study sought to compare TTE and cardiac magnetic resonance (CMR) for assessment of AR in patients undergoing TAVI with a balloon-expandable valve. Methods TTE and CMR exams were performed pre-TAVI in 50 patients and were repeated postprocedure in 42 patients. All imaging data were analysed in centralised core laboratories. Results The severity of native AR as determined by multiparametric TTE approach correlated well with the regurgitant volume and regurgitant fraction determined by CMR prior to TAVI (Rs=0.79 and 0.80, respectively; p<0.001 for both). However, after TAVI, the correlation between the prosthetic AR severity assessed by TTE and regurgitant volume and fraction measured by CMR was only modest (Rs=0.59 and 0.59, respectively; p<0.001 for both), with an underestimation of AR severity by TTE in 61.9% of patients (1 grade in 59.5%). The TTE jet diameter in parasternal view and the multiparametric approach (Rs=0.62 and 0.59, respectively; both with p<0.001) showed the best correlation with CMR regurgitant fraction post-TAVI. The circumferential extent of prosthetic paravalvular regurgitation showed a poor correlation with CMR regurgitant volume and fraction (Rs=0.32, p=0.084; Rs=0.36, p=0.054, respectively). Conclusions The severity of AR following TAVI with a balloon-expandable valve was underestimated by echocardiography as compared with CMR. The jet diameter, but not the circumferential extent of the leaks, and the multiparametric echocardiography integrative approach best correlated with CMR findings. These results provide important insight into the evaluation of AR severity post-TAVI.

Chronic Obstructive Pulmonary Disease in Patients Undergoing Transcatheter Aortic Valve Implantation: Insights on Clinical Outcomes, Prognostic Markers, and Functional Status Changes

OBJECTIVES This study sought to determine the effects of chronic obstructive pulmonary disease (COPD) on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) and to determine the factors associated with worse outcomes in COPD patients. BACKGROUND No data exist on the factors determining poorer outcomes in COPD patients undergoing TAVI. METHODS A total of 319 consecutive patients (29.5% with COPD) who underwent TAVI were studied. Functional status was evaluated by New York Heart Association (NYHA) functional class, Duke Activity Status Index, and the 6-min walk test (6MWT) at baseline and at 6 to 12 months. The TAVI treatment was considered futile if the patient either died or did not improve in NYHA functional class at 6-month follow-up. RESULTS Survival rates at 1 year were 70.6% in COPD patients and 84.5% in patients without COPD (p = 0.008). COPD was an independent predictor of cumulative mortality after TAVI (hazard ratio: 1.84; 95% confidence interval: 1.08 to 3.13; p = 0.026). Improvement in functional status was observed after TAVI (p < 0.001 for NYHA functional class, Duke Activity Status Index, and 6MWT), but COPD patients exhibited less (p = 0.036) improvement in NYHA functional class. Among COPD patients, a shorter 6MWT distance predicted cumulative mortality (p = 0.013), whereas poorer baseline spirometry results (FEV1 [forced expiratory volume in the first second of expiration]) determined a higher rate of periprocedural pulmonary complications (p = 0.040). The TAVI treatment was futile in 40 COPD patients (42.5%) and a baseline 6MWT distance <170 m best determined the lack of benefit after TAVI (p = 0.002). CONCLUSIONS COPD was associated with a higher rate of mortality at mid-term follow-up. Among COPD patients, a higher degree of airway obstruction and a lower exercise capacity determined a higher risk of pulmonary complications and mortality, respectively. TAVI was futile in more than one-third of the COPD patients, and a shorter distance walked at the 6MWT predicted the lack of benefit after TAVI. These results may help to improve the clinical decision-making process in this challenging group of patients.

Clinical impact and evolution of mitral regurgitation following transcatheter aortic valve replacement: a meta-analysis

Objectives Mitral regurgitation (MR) is a common entity in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), but its influence on outcomes remains controversial. The purpose of this meta-analysis was to assess the clinical impact of and changes in significant (moderate–severe) MR in patients undergoing TAVR, overall and according to valve design (self-expandable (SEV) vs balloon-expandable (BEV)). Methods All national registries and randomised trials were pooled using meta-analytical guidelines to establish the impact of moderate–severe MR on mortality after TAVR. Studies reporting changes in MR after TAVR on an individual level were electronically searched and used for the analysis. Results Eight studies including 8015 patients (SEV: 3474 patients; BEV: 4492 patients) were included in the analysis. The overall 30-day and 1-year mortality was increased in patients with significant MR (OR 1.49, 95% CI 1.16 to 1.92; HR 1.32, 95% CI 1.12 to 1.55, respectively), but a significant heterogeneity across studies was observed (p<0.05). The impact of MR on mortality was not different between SEV and BEV in meta-regression analysis for 30-day (p=0.360) and 1-year (p=0.388) mortality. Changes in MR over time were evaluated in nine studies including 1278 patients. Moderate–severe MR (SEV: 326 patients; BEV: 192 patients) improved in 50.5% of the patients at a median follow-up of 180 (30–360) days after TAVR, and the degree of improvement was greater in patients who had received a BEV (66.7% vs 40.8% in the SEV group, p=0.001). Conclusions Concomitant moderate–severe MR was associated with increased early and late mortality following TAVR. A significant improvement in MR severity was detected in half of the patients following TAVR, and the degree of improvement was greater in those patients who had received a BEV.

Arrhythmia Burden in Elderly Patients With Severe Aortic Stenosis as Determined by Continuous Electrocardiographic Recording Toward a Better Understanding of Arrhythmic Events After Transcatheter Aortic Valve Replacement

Background— This study sought to evaluate the prevalence of previously undiagnosed arrhythmias in candidates for transcatheter aortic valve replacement (TAVR) and to determine the impact on therapy changes and arrhythmic events after the procedure. Methods and Results— A total of 435 candidates for TAVR underwent 24-hour continuous ECG monitoring the day before the procedure. Newly diagnosed arrhythmias were observed in 70 patients (16.1%) before TAVR: paroxysmal atrial fibrillation (AF)/atrial tachycardia (AT) in 28, advanced atrioventricular block or severe bradycardia in 24, nonsustained ventricular tachycardia in 26, and intermittent left bundle-branch block in 3 patients. All arrhythmic events but one were asymptomatic and led to a therapy change in 43% of patients. In patients without known AF/AT, the occurrence of AF/AT during 24-hour ECG recording was associated with a higher rate of 30-day cerebrovascular events (7.1% versus 0.4%; P=0.030). Among the 53 patients with new-onset AF/AT after TAVR, 30.2% had newly diagnosed paroxysmal AF/AT before the procedure. In patients who needed permanent pacemaker implantation after the procedure (n=35), 31.4% had newly diagnosed advanced atrioventricular block or severe bradycardia before TAVR. New-onset persistent left bundle-branch block after TAVR occurred in 37 patients, 8.1% of whom had intermittent left bundle-branch block before the procedure. Conclusions— Newly diagnosed arrhythmias were observed in approximately a fifth of TAVR candidates, led to a higher rate of cerebrovascular events, and accounted for a third of arrhythmic events after the procedure. This high arrhythmia burden highlights the importance of an early diagnosis of arrhythmic events in such patients to implement the appropriate therapeutic measures earlier.

Arrhythmia Burden in Elderly Patients with Severe Aortic Stenosis as Determined by Continuous ECG Recording: Towards a Better Understanding of Arrhythmic Events Following Transcatheter Aortic Valve Replacement

Background— This study sought to evaluate the prevalence of previously undiagnosed arrhythmias in candidates for transcatheter aortic valve replacement (TAVR) and to determine the impact on therapy changes and arrhythmic events after the procedure. Methods and Results— A total of 435 candidates for TAVR underwent 24-hour continuous ECG monitoring the day before the procedure. Newly diagnosed arrhythmias were observed in 70 patients (16.1%) before TAVR: paroxysmal atrial fibrillation (AF)/atrial tachycardia (AT) in 28, advanced atrioventricular block or severe bradycardia in 24, nonsustained ventricular tachycardia in 26, and intermittent left bundle-branch block in 3 patients. All arrhythmic events but one were asymptomatic and led to a therapy change in 43% of patients. In patients without known AF/AT, the occurrence of AF/AT during 24-hour ECG recording was associated with a higher rate of 30-day cerebrovascular events (7.1% versus 0.4%; P=0.030). Among the 53 patients with new-onset AF/AT after TAVR, 30.2% had newly diagnosed paroxysmal AF/AT before the procedure. In patients who needed permanent pacemaker implantation after the procedure (n=35), 31.4% had newly diagnosed advanced atrioventricular block or severe bradycardia before TAVR. New-onset persistent left bundle-branch block after TAVR occurred in 37 patients, 8.1% of whom had intermittent left bundle-branch block before the procedure. Conclusions— Newly diagnosed arrhythmias were observed in approximately a fifth of TAVR candidates, led to a higher rate of cerebrovascular events, and accounted for a third of arrhythmic events after the procedure. This high arrhythmia burden highlights the importance of an early diagnosis of arrhythmic events in such patients to implement the appropriate therapeutic measures earlier.

Prosthetic Valve Endocarditis After Transcatheter Valve Replacement: A Systematic Review

OBJECTIVES The aim of this review is to describe the incidence, features, predisposing factors, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter valve replacement (TVR). BACKGROUND Very few data exist on PVE after TVR. METHODS Studies published between 2000 and 2013 regarding PVE in patients with transcatheter aortic valve replacement (TAVR) or transcatheter pulmonary valve replacement (TPVR) were identified through a systematic electronic search. RESULTS A total of 28 publications describing 60 patients (32 TAVRs, 28 TPVRs) were identified. Most TAVR patients (66% male, 80 ± 7 years of age) had a very high-risk profile (mean logistic EuroSCORE: 30.4 ± 14.0%). In TPVR patients (90% male, 19 ± 6 years of age), PVE was more frequent in the stenotic conduit/valve (61%). The median time between TVR and infective endocarditis was 5 months (interquartile range: 2 to 9 months). Typical microorganisms were mostly found with a higher incidence of enterococci after TAVR (34.4%), and Staphylococcus aureus after TPVR (29.4%). As many as 60% of the TAVR-PVE patients were managed medically despite related complications such as local extension, embolism, and heart failure in more than 50% of patients. The valve explantation rate was 57% and 23% in balloon- and self-expandable valves, respectively. In-hospital mortality for TAVR-PVE was 34.4%. Most TPVR-PVE patients (75%) were managed surgically, and in-hospital mortality was 7.1%. CONCLUSIONS Most cases of PVE post-TVR involved male patients, with a very high-risk profile (TAVR) or underlying stenotic conduit/valve (TPVR). Typical, but different, microorganisms of PVE were involved in one-half of the TAVR and TPVR cases. Most TPVR-PVE patients were managed surgically as opposed to TAVR patients, and the mortality rate was high, especially in the TAVR cohort.