Abstract Objectives The aim of this study was to identify variables associated with tissue fragment embolization during transcatheter aortic valve replacement (TAVR). Background Brain magnetic ...resonance imaging and transcranial Doppler studies have revealed that cerebrovascular embolization occurs frequently during TAVR. Embolized material may be r thrombotic, tissue derived, or catheter (foreign material) fragments. Methods A total of 81 patients underwent TAVR with a dual filter–based embolic protection device (Montage Dual Filter System, Claret Medical, Inc., Santa Rosa, California) deployed in the brachiocephalic trunk and left common carotid artery. Both balloon-expandable and self-expanding transcatheter heart valves (THVs) were used. Filters were retrieved after TAVR and sent for histopathological analysis. Results Overall, debris was captured in 86% of patients. Captured material varied in size from 0.1 to 9.0 mm. Thrombotic material was found in 74% of patients and tissue-derived debris in 63%. Tissue fragments were found more often with balloon-expandable THVs (79% vs. 56%; p = 0.05). The embolized tissue originated from the native aortic valve leaflets, aortic wall, or left ventricular myocardium. On multivariable logistic regression analysis, balloon-expandable THVs (odds ratio: 7.315; 95% confidence interval: 1.398 to 38.289; p = 0.018) and cover index (odds ratio: 1.141; 95% confidence interval: 1.014 to 1.283; p = 0.028) were independent predictors of tissue embolization. Conclusions Debris is captured with filter-based embolic protection in the vast majority of patients undergoing TAVR. Tissue-derived material is found in 63% of cases and is more frequent with the use of balloon-expandable systems and more oversizing.
Objectives This study sought to compare all-cause mortality in patients at intermediate surgical risk undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement ...(SAVR). Background Physicians are selecting “lower” surgical risk patients to undergo TAVI. No clinical data exist about the clinical outcomes of TAVI versus SAVR among intermediate-surgical-risk patients. Methods We prospectively enrolled symptomatic patients with severe aortic stenosis who underwent TAVI or SAVR. Propensity-score matched pairs of TAVI and SAVR patients with Society of Thoracic Surgeons (STS) scores between 3% and 8% made up the study population. Primary endpoint was all-cause mortality at 1 year. Results Between November 2006 and January 2010, 3,666 consecutive patients underwent either TAVI (n = 782) or SAVR (n = 2,884). Four hundred five TAVI patients were matched to 405 SAVR patients. Of matched TAVI patients, 99 (24%) patients had STS scores <3%, 255 (63%) had scores between 3% and 8%, and 51 (13%) had scores >8%. Among patients with STS scores between 3% and 8%, 20 (7.8%) versus 18 (7.1%) patients had died up to 30 days (hazard ratio: 1.12, 95% confidence interval: 0.58 to 2.15, p = 0.74) and 42 (16.5%) versus 43 (16.9%) patients had died up to 1 year (hazard ratio: 0.90, 95% confidence interval: 0.57 to 1.42, p = 0.64) after TAVI and SAVR, respectively. Effects of treatment on 1-year mortality were similar across all subgroups except for sex, with some evidence for a beneficial effect of TAVI in women but not in men (test for interaction p = 0.024). Conclusions Cumulative all-cause mortality at 30 days and 1 year was similar among propensity-score matched TAVI and SAVR patients at intermediate surgical risk. (Surgical Replacement and Transcatheter Aortic Valve Implantation SURTAVI; NCT01586910 )
Objectives The study sought to evaluate the clinical impact of angiographic complete (CR) and incomplete (ICR) revascularization and its association with the presence of total occlusions (TO), after ...percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery in the “all-comers” SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial. Background In patients with complex coronary artery disease undergoing PCI or CABG, the long-term prognostic implications of CR versus ICR is unsettled. Methods In this post hoc study, consisting of randomized (n = 1,800) and nested PCI (n = 198) and CABG (n = 649) registries, 4-year clinical outcomes were compared in groups, with and without angiographic CR, in the PCI and CABG arms. Clinical outcomes were analyzed with Kaplan-Meier estimates, log-rank comparisons, and Cox regression analyses. Multivariate predictors of ICR were determined. Similar analyses were undertaken in the TO and non-TO treated groups of both study arms. Results Angiographic CR was achieved in 52.8% of the PCI arm and 66.9% of the CABG arm. Within the PCI and CABG arms, ICR (compared with CR) seemed to be a surrogate marker of a greater burden of anatomical coronary complexity and clinical comorbidity and was associated with significantly higher frequencies of 4-year mortality, all-cause revascularization, stent thrombosis (PCI arm), and major adverse cardiac and cerebrovascular events. The presence of a TO was the strongest independent predictor of ICR after PCI (hazard ratio: 2.70, 95% confidence interval: 1.98 to 3.67, p < 0.001). Eight hundred and forty patients (PCI: 26.3%, CABG: 36.4%, p < 0.001) were identified to have 1,007 TOs, with 68.1% of TOs located in the proximal-mid coronary vasculature. The findings associating ICR (compared with CR) with higher frequencies of 4-year mortality and major adverse cardiac and cerebrovascular events remained consistent in the TO-treated groups in the PCI and CABG arms. Conclusions Within the PCI and CABG arms of the all-comers SYNTAX trial, angiographically determined ICR has a detrimental impact on long-term clinical outcomes, including mortality. This effect remained consistent in patients with and without TOs.
Objectives This study sought to assess in patients undergoing transcatheter aortic valve implantation (TAVI), the prevalence and impact of incomplete coronary revascularization defined as >50% ...coronary artery or graft diameter stenosis on visual assessment of the coronary angiogram. Background TAVI is an established treatment option in elderly patients with aortic stenosis (AS) and a (very) high operative risk. Coronary artery disease (CAD) is often associated with AS. Methods A single-center cohort of consecutive patients undergoing TAVI between November 2005 and June 2012 was evaluated for the presence of significant CAD. The decision to revascularize and pursue complete revascularization was made by heart team consensus. Results A total of 263 consecutive patients with a mean age of 80 ± 7 years and 51% male underwent TAVI with a median follow-up duration of 16 months (interquartile range: 4.2 to 28.1 months). Significant CAD with myocardium at risk was present in 124 patients (47%), 44 of whom had had previous coronary artery bypass grafting (CABG), and the median SYNTAX score in the 81 patients without previous CABG was 9.00 (2.38 to 15.63). Staged percutaneous coronary intervention (PCI) was planned in 19 (15%) and concomitant PCI with TAVI in 20 (16%). The median post-procedural residual SYNTAX score of patients without prior CABG was 5.00 (0.13 to 9.88). Overall, 99 patients (37%) (61 with no CABG and 38 CABG patients) had incomplete revascularization after TAVI. Revascularization status did not affect clinical endpoints. Kaplan-Meier survival curves for patients with and without complete revascularization demonstrated a 1-year mortality of 79.9% versus 77.4% (p = 0.85), respectively. Conclusions In an elderly patient population undergoing TAVI for severe AS, a judicious revascularization strategy selection by a dedicated heart team can generate favorable mid-term outcome obviating the need for complete coronary revascularization.
The Syntax score (SXscore) was recently developed as a comprehensive angiographic scoring system aiming to assist in patient selection and risk stratification of patients with extensive coronary ...artery disease undergoing contemporary revascularization. A validation of this angiographic classification scheme is lacking. We assessed its predictive value in patients who underwent percutaneous intervention (PCI) for 3-vessel disease and explored its performance in comparison with the modified lesion classification system of the American Heart Association/American College of Cardiology. The SXscore, applied to 1,292 lesions in 306 patients who underwent PCI for 3-vessel disease in the Arterial Revascularization Therapies Study Part II, was 4 to 54.5, and after a median of 370 days (range 274 to 400) predicted the rate of major adverse cardiac and cerebrovascular events (hazard ratio 1.08/U increase, 95% confidence interval 1.05 to 1.11, p <0.0001), with patients in the highest SXscore tertile having a significantly higher event rate (27.9%) than patients in the lowest tertile (8.7%, hazard ratio 3.5, 95% confidence interval 1.7 to 7.4, p = 0.001). By multivariable analyses, SXscore independently predicted outcome with an almost fourfold adjusted increase in the risk of major adverse cardiac and cerebrovascular events in patients with high versus low values based on the discrimination level provided by classification and regression tree analysis. Compared with the modified lesion classification scheme of the American Heart Association/American College of Cardiology, SXscore showed a greater discrimination ability (c-index 0.58 ± 0.08 vs 0.67 ± 0.08, respectively, p <0.001) and a better goodness of fit with the Hosmer-Lemeshow statistic. In conclusion, the SXscore is a promising tool to risk stratify outcome in patients with extensive coronary artery disease undergoing contemporary PCI.
Abstract Background Co-existence of moderate aortic stenosis (AS) in patients with heart failure with reduced ejection fraction (HFrEF) is not uncommon. Moderate AS increases afterload, while ...pharmacological reduction of afterload is a pillar of contemporary heart failure management. Hypothesis Unloading the left ventricle by reducing the trans-aortic gradient with transfemoral transcatheter aortic valve replacement (TAVR) may improve clinical outcomes in patients with moderate aortic stenosis and HF with reduced ejection fraction. Study Design TAVR UNLOAD ( NCT02661451 ) is an international, multi-center, randomized, open-label, clinical trial comparing the efficacy and safety of TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve in addition to optimal heart failure therapy (OHFT) versus OHFT alone in patients with moderate AS (defined by a mean trans-aortic gradient ≥20 mmHg and <40 mmHg, and an aortic valve area> 1.0 cm2 and ≤1.5 cm2 at rest or after dobutamine stress echocardiography) and HFrEF. A total of 600 patients will be randomized in a 1:1 fashion. Clinical follow-up is scheduled at 1, 6 and 12 months, and 2 years after randomization. The primary endpoint is the hierarchical occurrence of all-cause death, disabling stroke, hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke, and the change in the Kansas City Cardiomyopathy Questionnaire at one year. Secondary endpoints capture effects on clinical outcome, biomarkers, echocardiographic parameters, and quality of life. Summary The TAVR UNLOAD trial aims to test the hypothesis that TAVR on top of optimal heart failure therapy improves clinical outcomes in patients with moderate aortic stenosis and heart failure with reduced ejection fraction.
Outcome after transcatheter aortic valve implantation (TAVI) depends on the patient risk profile, operator experience, progress in technology, and technique. We sought to compare the results of TAVI ...during the initiation phase and after certification to perform TAVI with the Medtronic CoreValve System without proctoring. A total of 165 consecutive patients was categorized into a first cohort of 33 patients treated before certification (November 2005 to December 2007) and a second cohort of 132 patients treated after certification (January 2008 to October 2010). The study end points were selected and defined according to the Valve Academic Research Consortium recommendations. Compared to cohort 2, the patients in cohort 1 more frequently had New York Heart Association class III–IV (100% vs 71%, p <0.001), hypertension (67% vs 39%, p = 0.004), and aortic regurgitation grade III–IV (46% vs 22%, p = 0.006) before TAVI. Over time, the patients in cohort 2 more frequently underwent a truly percutaneous approach (98% vs 82%, p = 0.002) without circulatory support (96% vs 67%, p <0.001) but with more concomitant percutaneous coronary intervention (11% vs 0%, p = 0.042) than the patients in cohort 1. They also more often received a 29-mm prosthesis (72% vs 24%, p <0.001), required less postimplantation balloon dilation (10% vs 27%, p = 0.008), and had less aortic regurgitation grade III–IV after TAVI (12% vs 30%, p = 0.010). The clinical outcome showed a nonsignificant reduction in the combined safety end point (30% to 17%) but a significant reduction in cerebrovascular events (21% to 7%, p = 0.020) and life-threatening bleeding (15% to 5%, p = 0.044) in cohort 2. However, the reduction in overall bleeding and vascular complications (25% and 14%, respectively) was not significant. In conclusion, TAVI became significantly less complex and was associated with better results over time but remained associated with a high frequency of periprocedural major cardiovascular complications.
Degenerative aortic valve stenosis (AS) is associated with conduction abnormalities. Pacemaker implantation is encountered after surgical aortic valve replacement (SAVR). Not much is known about the ...pacemaker implantation rate during midterm follow-up after SAVR. Our objectives were to determine the incidence of permanent pacemaker implantation (PPI) in the midterm after SAVR in a tertiary care facility.
We reviewed procedural data of 734 consecutive patients (56% men; mean age, 68.9±9.5 years) with degenerative severe AS who underwent SAVR between January 1, 2003, and December 31, 2008. Perioperative electrocardiograms were assessed for occurrence of conduction abnormalities, and we sought to determine the incidence and indication for PPI with a median follow-up of 3.76 years (interquartile range, 2.44 to 5.59 years). Univariate and multivariate logistic regression models were applied to identify predictors for early (≤30 days) and late (>30 days) PPI.
Isolated SAVR was performed in 56%, SAVR with coronary artery bypass grafting in 35%, and SAVR with any other valve therapy in 5.8%. Complete bundle branch block (BBB) was present in 7% and first-degree atrioventricular block in 11%. New BBBs were detected in 63 patients (8.6%). Fifteen patients (2.0%) required a PPI within 30 days after SAVR, and 28 (4.0%) underwent PPI more than 30 days after SAVR. The linearized rate of PPI after SAVR was 1.01%±0.37% per patient-year. Patients with BBB at baseline had a higher PPI incidence after SAVR than patients without BBB, both within 30 days (8% vs 1.5%, p=0.001) and after 30 days (10% vs 2.9%, p=0.006). PPI incidence after 30 days was also significantly higher in patients with a new BBB after SAVR (7.8% vs 2.9%, p=0.038). By multivariate logistic regression analysis, BBB and the combination of AS and regurgitation predicted PPI within 30 days after SAVR (hazard ratio HR, 470; 95% confidence interval CI, 1.55 to 14.27; and HR, 1.33; 95% CI, 0.03 to 1.73, respectively). BBB (HR, 3.26; 95% CI, 1.41 to 7.54), previous cardiac operation (HR, 3.40; 95% CI, 1.16 to 9.94), and severe left ventricular dysfunction (HR, 9.82; 95% CI, 2.90 to 33.26) were predictors for PPI after 30 days post-SAVR.
Patients with severe AS who underwent SAVR have a persistent 1% annual risk for PPI. Postoperative presence of BBB predicted the need for PPI both within 30 days and after 30 days after SAVR.
A prosthesis–patient mismatch (PPM) is present when the prosthetic valve is too small in relation to the patient's body size. The purpose of the present study was to investigate the frequency of PPM ...after the implantation of the Medtronic CoreValve System, and its relation to the clinical outcome. The indexed effective orifice area (EOA) was measured in 74 patients with symptomatic severe aortic stenosis, who had undergone successful transcatheter aortic valve implantation with the Medtronic CoreValve System, at baseline and discharge. PPM was defined as severe (indexed EOA <0.65 cm2 /m2 ) or moderate (indexed EOA 0.65 to 0.85 cm2 /m2 ). The indexed EOA increased from 0.35 ± 0.13 to 0.97 ± 0.34 cm2 /m2 after transcatheter aortic valve implantation (p <0.001) and was accompanied by significant clinical improvement. Severe and moderate PPMs were found in 16% and 23% of patients, respectively. Patients with severe PPM were more symptomatic and had a smaller indexed EOA at baseline than those with moderate or no PPM (0.28 ± 0.09 vs 0.36 ± 0.12 cm2 /m2 , p <0.05). Functional status and mortality at 30 days and 6 months was not significantly different between the patients with severe PPM and those with moderate or no PPM. In conclusion, the indexed EOA increased significantly after transcatheter aortic valve implantation. Severe PPM was observed in 16% of the patients and was not associated with the clinical outcome.
Abstract Objective Despite various evidence supporting the advantages of multiple arterial grafting, inconsistencies in use of the procedure have resulted in high variability in the acceptance and ...practice of arterial grafting. The purpose of this study was to assess the effects of an arterial versus venous second grafts on outcomes at 5-year follow-up in the coronary artery bypass grafting population from the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial. Methods Patients (n = 1419) with an arterial graft to the left anterior descending artery and ≥1 other graft were included and divided according to the second graft's type: 2nd-graft-arterial group (n = 456) and 2nd-graft-venous group (n = 963). Five-year outcomes were compared between subgroups. Event rates were estimated with Kaplan-Meier analyses. Propensity-score matching was used, to control for selection bias due to nonrandom group assignment in a 1:1 manner, resulting in 432 pairs with balanced baseline characteristics. Results In unmatched groups, the 2nd-graft-arterial group had significantly lower rates of death (8.9% vs 13.1%; P = .02), and composite safety endpoint of death/stroke/myocardial infarction (13.3% vs 18.7%; P = .02), compared with the 2nd-graft-venous group. The rate of major adverse cardiac or cerebrovascular events was similar between groups (22.9% vs 25.5%; P = .30), because it includes the rate of repeat revascularization (12.6% in the 2nd-graft-arterial group vs 9.6% in the 2nd-graft-venous group; P = .10). After propensity-score matching, no statistically significant differences were found between groups. Conclusions This study reveals comparable 5-year outcomes with arterial and venous conduits as second grafts after an arterial graft anastomosed to the left anterior descending artery. This study demonstrates the multi-institutional variation in patient selection and operator technique with regard to arterial revascularization, although extended follow-up beyond 5 years is required to estimate its impact on long-term outcomes. Clinical Trial Number NCT00114972
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