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Transcatheter aortic valve replacement in bicuspid aortic valve disease.

BACKGROUND Limited information exists describing the results of transcatheter aortic valve (TAV) replacement in patients with bicuspid aortic valve (BAV) disease (TAV-in-BAV). OBJECTIVES This study sought to evaluate clinical outcomes of a large cohort of patients undergoing TAV-in-BAV. METHODS We retrospectively collected baseline characteristics, procedural data, and clinical follow-up findings from 12 centers in Europe and Canada that had performed TAV-in-BAV. RESULTS A total of 139 patients underwent TAV-in-BAV with the balloon-expandable transcatheter heart valve (THV) (n = 48) or self-expandable THV (n = 91) systems. Patient mean age and Society of Thoracic Surgeons predicted risk of mortality scores were 78.0 ± 8.9 years and 4.9 ± 3.4%, respectively. BAV stenosis occurred in 65.5%, regurgitation in 0.7%, and mixed disease in 33.8% of patients. Incidence of type 0 BAV was 26.7%; type 1 BAV was 68.3%; and type 2 BAV was 5.0%. Multislice computed tomography (MSCT)-based TAV sizing was used in 63.5% of patients (77.1% balloon-expandable THV vs. 56.0% self-expandable THV, p = 0.02). Procedural mortality was 3.6%, with TAV embolization in 2.2% and conversion to surgery in 2.2%. The mean aortic gradient decreased from 48.7 ± 16.5 mm Hg to 11.4 ± 9.9 mm Hg (p < 0.0001). Post-implantation aortic regurgitation (AR) grade ≥ 2 occurred in 28.4% (19.6% balloon-expandable THV vs. 32.2% self-expandable THV, p = 0.11) but was prevalent in only 17.4% when MSCT-based TAV sizing was performed (16.7% balloon-expandable THV vs. 17.6% self-expandable THV, p = 0.99). MSCT sizing was associated with reduced AR on multivariate analysis (odds ratio [OR]: 0.19, 95% confidence intervals [CI]: 0.08 to 0.45; p < 0.0001). Thirty-day device safety, success, and efficacy were noted in 79.1%, 89.9%, and 84.9% of patients, respectively. One-year mortality was 17.5%. Major vascular complications were associated with increased 1-year mortality (OR: 5.66, 95% CI: 1.21 to 26.43; p = 0.03). CONCLUSIONS TAV-in-BAV is feasible with encouraging short- and intermediate-term clinical outcomes. Importantly, a high incidence of post-implantation AR is observed, which appears to be mitigated by MSCT-based TAV sizing. Given the suboptimal echocardiographic results, further study is required to evaluate long-term efficacy.

Response to Prasugrel and Levels of Circulating Reticulated Platelets in Patients With ST-Segment Elevation Myocardial Infarction

OBJECTIVES The aim of this study was to determine whether response to prasugrel is associated with the proportion of circulating reticulated platelets (RPs) in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND Despite better pharmacodynamic properties and clinical efficacy of prasugrel compared with clopidogrel, antiplatelet responses to prasugrel are not uniform. The mechanism of this variability in response is not clear. RPs, young hyperactive forms, are increased during situations of enhanced platelet turnover. METHODS Patients with STEMI treated with primary percutaneous intervention (PCI) and prasugrel were tested for platelet reactivity using purinergic receptor P₂Y, G-protein coupled, 12 (P₂Y₁₂) assay and multiple electrode aggregometry (MEA). RP levels were determined using flow cytometry with thiazole orange staining. Tests were performed at 2 to 4 days and 30 days post-PCI. Platelet function was compared by varying levels of RPs, analyzed as continuous (regression analysis) and categorical (tertiles) variables. RESULTS Sixty-two patients were included (mean age: 57.5 ± 8 years; 21.2% women; 27.7% diabetes). At the early time point, RP levels were strongly correlated with platelet reactivity when evaluated by the P₂Y₁₂ assay (Spearmans correlation coefficient: 0.55 for P₂Y₁₂ reaction units, -0.49 for percent inhibition) and MEA (Spearmans: 0.50). The upper tertile of RPs displayed higher platelet reactivity compared with the middle and lower tertiles, according to P₂Y₁₂ assay and MEA. Similar results with strong correlations between RP and platelet reactivity were noted at 30 days post-PCI. CONCLUSIONS The proportion of circulating RPs strongly correlates with response to prasugrel in patients with STEMI treated with PCI. High levels of RPs are associated with increased platelet reactivity despite prasugrel treatment.

Long-Term Outcomes for Patients With Severe Symptomatic Aortic Stenosis Treated With Transcatheter Aortic Valve Implantation.

Transcatheter aortic valve implantation (TAVI) is an emerging technique for the treatment of severe symptomatic aortic stenosis. Little has been reported about the use of different devices and multiple catheter-based options and anesthetic techniques in the same institution. We report the long-term clinical experience in treating patients with severe symptomatic aortic stenosis using TAVI. We analyzed the outcomes of 153 TAVI-treated patients who were followed for ≤2 years. All patients were at very high risk of surgical valve replacement. The Medtronic-CoreValve device was used in 59.5% and the Edwards-SAPIEN device in 40.5% of the patients. The primary end point was death from any cause during follow-up. The mean ± SD patient age was 81.1 ± 6 years, and 62% of the patients were women. The procedural success rate was 97.4%. At 30 days of follow-up, the all-cause mortality was 3.9%. Two-year follow-up data were obtained for 108 patients, with 85.5% survival of treated patients. The 30-day stroke rate was 3.9%. No significant differences in mortality were found when angioplasty was performed before or during TAVI compared with TAVI alone. Multivariate analysis showed that increased baseline creatinine (hazard ratio 1.55, 95% confidence interval 1.01 to 2.42, p = 0.049) and increased logistic European System for Cardiac Operative Risk Evaluation score (hazard ratio 1.03, 95% confidence interval 1.01 to 1.06, p = 0.048) predicted all-cause mortality. In conclusion, the clinical outcome of TAVI is favorable. The use of both procedural devices and multiple techniques in the same institution is feasible and potentially desirable.

Long-term outcome of patients with antiphospholipid syndrome who undergo percutaneous coronary intervention.

Objectives: Patients with antiphospholipid antibody syndrome (APS) have an increased risk of atherothrombotic complications. There are limited data regarding the outcome of patients with APS who undergo percutaneous coronary intervention (PCI). Accordingly, we aimed to assess the long-term outcomes of these patients. Methods: Nineteen APS patients who underwent PCI between the years 2003 and 2008 were compared to 380 patients who had undergone PCI during the same period (PCI group) and were matched by age (±5 years), gender, diabetes and hypertension. In addition, APS patients were compared to 1,458 patients with ST segment elevation myocardial infarction (MI) who were treated with PCI during the same period. Six-month to 4-year clinical outcomes were evaluated. Results: The indication for PCI in the APS group was acute coronary syndrome in 52.6% of patients. After 1 year of follow-up, patients with APS had higher rates of target vessel revascularization than the other two groups, which translated to higher rates of major adverse cardiac events. There were no differences in MI or mortality rates between the groups. Conclusions: Patients with APS who undergo PCI have worse long-term clinical outcomes, driven by higher rates of revascularization, than other patients undergoing PCI. Further study is warranted to examine the mechanisms underlying these findings.

Urgent Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis and Acute Heart Failure: Procedural and 30-Day Outcomes.

BACKGROUND Transcatheter aortic valve implantation (TAVI) is recommended for patients with severe symptomatic aortic stenosis (AS) who are at prohibitive/high risk for surgical aortic valve replacement (SAVR). Patients with severe AS may experience acute decompensated heart failure (HF) that is resistant to medical therapy. We report our TAVI experience in treating patients with unstable AS who require urgent intervention for their aortic valve disease. METHODS Patients were restrictively included in the urgent TAVI registry if they were admitted with acute refractory and persistent HF despite medical therapy and had TAVI performed during the same hospital stay. All others were included in the elective TAVI group. RESULTS Between November 2008 and April 2015, 410 consecutive patients underwent TAVI at our centre-27 (6.6%) urgently. Patients operated on urgently were more likely to be frail and carry higher SAVR mortality risk based on The Society of Thoracic Surgeons Predicted Risk of Mortality/logistic EuroSCORE (LES) measures. Pulmonary edema was the most common clinical presentation. Preprocedural assessment used fewer imaging modalities, yet implantation success remained high and reached 96.3% using an additional valve (valve-within-valve) required in 3 patients, with no difference in periprocedural complications according to the Valve Academic Research Consortium-2 definitions. Although 30-day functional capacity was reduced, patients had similar 30-day mortality and major adverse cardiovascular event rates compared with patients who underwent elective TAVI. CONCLUSIONS Short-term outcome after urgent TAVI appears to be reasonable. For patients with severe AS who experience acute decompensated HF that is recalcitrant to optimal medical therapy and who are at high risk with SAVR, urgent TAVI may be a viable treatment strategy. Larger prospective studies and data on long-term outcomes are needed.

Effect of coronary artery disease severity and revascularization completeness on 2-year clinical outcomes in patients undergoing transcatether aortic valve replacement.

AimsTo evaluate the effect of coronary artery disease (CAD) severity and completeness of revascularization on clinical outcomes following transcatheter aortic valve replacement (TAVR) using the SYNTAX score (SS), clinical SYNTAX score (cSS), and residual SYNTAX score (rSS). Methods and resultsWe studied 287 consecutive patients undergoing TAVR at our institution. Patients were classified as having CAD or no CAD and coronary patients were stratified according to SS and cSS. The completeness of revascularization was stratified using the rSS. We compared the 2-year outcomes according to SS/cSS/rSS. Forty-nine patients (17.1%) had CAD and sustained a higher rate of the primary endpoint at 2 years (28.3 vs. 16.1%, P=0.026). Stratified by CAD severity, the difference was driven by the high-severity groups (75.0 vs. 16.1%, P=0.002 for SS>22 and 41.2 vs. 16.1%, P=0.001 for cSS>63). Low-severity CAD patients did not have worse outcomes versus no CAD. When evaluating the effect of revascularization, patients with a rSS less than 8 did not have worse outcomes versus patients who did not have CAD. ConclusionIn patients undergoing TAVR, it is the severity of CAD (as assessed by the SS/cSS) that is associated with worse prognosis and not the mere presence of CAD. More complete revascularization attenuates the effect of CAD on clinical outcomes.

Validation Study of Image-Based Fractional Flow Reserve During Coronary Angiography

Background— Fractional flow reserve (FFR), an index of the hemodynamic severity of coronary stenoses, is derived from invasive measurements and requires a pressure-monitoring guidewire and hyperemic stimulus. Angiography-derived FFR measurements (FFRangio) may have several advantages. The aim of this study is to assess the diagnostic performance and interobserver reproducibility of FFRangio in patients with stable coronary artery disease. Methods and Results— FFRangio is a computational method based on rapid flow analysis for the assessment of FFR. FFRangio uses the patient’s hemodynamic data and routine angiograms to generate a complete 3-dimensional coronary tree with color-coded FFR values at any epicardial location. Hyperemic flow ratio is derived from an automatic resistance-based lumped model of the entire coronary tree. A total of 203 lesions were analyzed in 184 patients from 4 centers. Values derived using FFRangio ranged from 0.5 to 0.97 (median 0.85) and correlated closely (Spearman &rgr;=0.90; P<0.001) with the invasive FFR measurements, which ranged from 0.5 to 1 (median 0.84). In Bland–Altman analyses, the 95% limits of agreement between these methods ranged from −0.096 to 0.112. Using an FFR cutoff value of 0.80, the sensitivity, specificity, and diagnostic accuracy of FFRangio were 88%, 95%, and 93%, respectively. The intraclass coefficient between 2 blinded operators was 0.962 with a 95% confidence interval from 0.950 to 0.971, P<0.001. Conclusions— There is a high concordance between FFRangio and invasive FFR. The color-coded display of FFR values during coronary angiography facilitates the integration of physiology and anatomy for decision making on revascularization in patients with stable coronary artery disease. Clinical Trial Registration— URL: https://www.clinicaltrials.gov. Unique identifier: NCT03005028.

Type of Atrial Fibrillation and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement.

There are limited data available regarding the relationship between atrial fibrillation (AF) clinical type, oral anticoagulation (OAC) treatment, and clinical outcome after transcatheter aortic valve replacement (TAVR). The study was designed to evaluate this relationship.

Multivessel Versus Culprit-Only Revascularization: One Time Versus Staged Procedures for the ACS Population

Multivessel coronary artery disease is a frequent finding in patients with acute myocardial infarction. The proper management of nonculprit lesions in the setting of acute coronary syndromes has historically been a topic of major debate. Despite current guidelines that clearly recommend treatment only of the culprit lesion in this setting, unless there is hemodynamic instability, there is still no consensus about the best treatment strategy for these patients. This article summarizes international experience and authors’ opinion about this controversial topic.

Impact of Coronary Artery Revascularization Completeness on Outcomes of Patients With Coronary Artery Disease Undergoing Transcatheter Aortic Valve Replacement: A Meta-Analysis of Studies Using the Residual SYNTAX Score (Synergy Between PCI With Taxus and Cardiac Surgery)

Background— Coronary artery disease (CAD) is highly prevalent in patients undergoing transcatheter aortic valve replacement. In the overall CAD population, complete revascularization or reasonable incomplete revascularization (ICR) is associated with improved outcomes; whether the same applies for the transcatheter aortic valve replacement population is still a matter of debate. Methods and Results— We conducted a systematic review and meta-analysis of studies that examined the prognostic effect of revascularization completeness in patients undergoing transcatheter aortic valve replacement using the residual SYNTAX score (Synergy Between PCI With Taxus and Cardiac Surgery) to separate between reasonable ICR and ICR (using the individual threshold used by each study). Six studies with a total of 3107 patients were included. The duration of follow-up ranged from 0.7 to 3 years. Overall, ICR was associated with an increased risk for mortality. This was true when comparing ICR patients to those with no CAD (odds ratio, 1.85; 95% confidence interval, 1.42–2.40; P<0.01), to those with reasonable ICR (odds ratio, 1.69; 95% confidence interval, 1.26–2.28; P<0.001), or to both groups combined (odds ratio, 1.71; 95% confidence interval, 1.36–2.16; P<0.001). On the contrary, patients in the reasonable ICR category did not show an increased risk for mortality when compared with those with no CAD (odds ratio, 1.11; 95% confidence interval, 0.89–1.39; P=0.33). Conclusions— Our results suggest that for patients with CAD undergoing transcatheter aortic valve replacement, a residual SYNTAX score–guided revascularization strategy may carry significant benefits in terms of mortality. Adequate revascularization may offer a unique and valuable opportunity to improve the prognosis of these patients.