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Transapical aortic valve replacement for severe aortic stenosis: results from the nonrandomized continued access cohort of the PARTNER trial
Dewey, Todd M; Bowers, Bruce; Thourani, Vinod H; Babaliaros, Vasilis; Smith, Craig R; Leon, Martin B; Svensson, Lars G; Tuzcu, E Murat; Miller, D Craig; Teirstein, Paul S; Tyner, Jeffrey; Brown, David L; Fontana, Gregory P; Makkar, Raj R; Williams, Mathew R; George, Isaac; Kirtane, Ajay J; Bavaria, Joseph E; Mack, Michael J
BACKGROUND: Transapical (TA) aortic valve replacement was an integral part of the Placement of Transcatheter Aortic Valves (PARTNER) trial. Enrollment during the randomized trial included 104 transapical (premarket approval TA [PMA-TA]) and 92 surgical aortic valve replacements (SAVR) within the TA cohort. On completion of the trial, enrollment continued in a nonrandomized continued access (NRCA) program. We compared the outcomes of NRCA-TA procedures with those of PMA-TA and SAVR. METHODS: In 22 centers, 975 patients underwent TA aortic valve replacement as part of the NRCA registry. Inclusion and exclusion criteria were unchanged from the previously reported PARTNER trial. All patients were followed up for at least 1 year. RESULTS: Thirty-day or in-hospital mortality was 8.8% for the NRCA-TA cohort, compared with 10.6% and 12.0% for the PMA-TA and SAVR patients, respectively (p = 0.54). One-year mortality in the NRCA-TA cohort was 22.1%, not significantly lower than the mortality in PMA-TA and SAVR patients at 29.0% and 25.3%, respectively (p = 0.27). Thirty-day or in-hospital stroke was 2.2% among NRCA-TA patients in contrast to the 6.7% stroke rate observed in the PMA-TA group and 5.4% in SAVR patients (p = 0.008). Lower rates of neurologic adverse events in the NRCA-TA group persisted at 1 year compared with the PMA-TA and SAVR patients. CONCLUSIONS: Among the 975 patients in the NRCA-TA cohort, rates of major outcomes including death and stroke compared favorably with outcomes of PMA-TA and SAVR patients enrolled in the PARTNER trial. This trend toward improved outcomes may be attributed to improved patient selection, individual centers surmounting the procedural learning curve, and refinements in surgical technique.
PMID: 23968764
ISSN: 0003-4975
CID: 1066952
Patient selection for transcatheter aortic valve replacement
Mack, Michael J; Holmes, David R; Webb, John; Cribier, Alain; Kodali, Susheel K; Williams, Mathew R; Leon, Martin B
PMID: 24135658
ISSN: 0735-1097
CID: 1066962
Relation between six-minute walk test performance and outcomes after transcatheter aortic valve implantation (from the PARTNER trial)
Green, Philip; Cohen, David J; Genereux, Philippe; McAndrew, Tom; Arnold, Suzanne V; Alu, Maria; Beohar, Nirat; Rihal, Charanjit S; Mack, Michael J; Kapadia, Samir; Dvir, Danny; Maurer, Mathew S; Williams, Mathew R; Kodali, Susheel; Leon, Martin B; Kirtane, Ajay J
Functional capacity as assessed by 6-minute walk test distance (6MWTD) has been shown to predict outcomes in selected cohorts with cardiovascular disease. To evaluate the association between 6MWTD and outcomes after transcatheter aortic valve implantation (TAVI) among participants in the Placement of AoRTic TraNscathetER valve (PARTNER) trial, TAVI recipients (n = 484) were stratified into 3 groups according to baseline 6MWTD: unable to walk (n = 218), slow walkers (n = 133), in whom 6MWTD was below the median (128.5 meters), and fast walkers (n = 133) with 6MWTD >128.5 meters. After TAVI, among fast walkers, follow-up 6MWTD decreased by 44 +/- 148 meters at 12 months (p <0.02 compared with baseline). In contrast, among slow walkers, 6MWTD improved after TAVI by 58 +/- 126 meters (p <0.001 compared with baseline). Similarly, among those unable to walk, 6MWTD distance increased by 66 +/- 109 meters (p <0.001 compared with baseline). There were no differences in 30-day outcomes among 6MWTD groups. At 2 years, the rate of death from any cause was 42.5% in those unable to walk, 31.2% in slow walkers, and 28.8% in fast walkers (p = 0.02), driven primarily by differences in noncardiac death. In conclusion, among high-risk older adults undergoing TAVI, baseline 6MWTD does not predict procedural outcomes but does predict long-term mortality. Nonetheless, patients with poor baseline functional status exhibit the greatest improvement in 6MWTD. Additional work is required to identify those with poor functional status who stand to benefit the most from TAVI.
PMCID:3745807
PMID: 23725996
ISSN: 0002-9149
CID: 1066972
Stent exteriorization facilitates surgical repair for large-bore sheath complications [Case Report]
George, Isaac; Shrikhande, Gautam; Williams, Mathew R
Endovascular therapy for peripheral vascular and valvular disease has rapidly expanded and yet also produced new challenges for vascular access and closure. Current generation thoracic endograft (TEVAR) outer diameter sheath sizes range from 18 to 25 French, and the options for vascular access closure include off-label use of a closure device versus surgical cutdown. We describe a patient with a complex, post-dissection, descending aortic aneurysm who required TEVAR and had a vascular access complication repaired with stent exteriorization with open repair.
PMID: 23475765
ISSN: 1522-1946
CID: 1066982
Predicting paravalvular regurgitation following transcatheter valve replacement: utility of a novel method for three-dimensional echocardiographic measurements of the aortic annulus
Hahn, Rebecca T; Khalique, Omar; Williams, Mathew R; Koss, Elana; Paradis, Jean-Michel; Daneault, Benoit; Kirtane, Ajay J; George, Isaac; Leon, Martin B; Kodali, Susheel
BACKGROUND: Studies evaluating three-dimensional echocardiographic (3DE) annular sizing for balloon-expandable transcatheter aortic valve replacement (TAVR) are limited. In this study, a retrospective analysis of transesophageal echocardiographic images was performed to assess the feasibility of multiplanar measurements of annular dimensions by the novel off-label use of commercially available 3DE software and correlate annular sizing with severity of paravalvular regurgitation (PVR). METHODS: Intraprocedural transesophageal echocardiography was performed in 58 patients undergoing TAVR for severe, symptomatic aortic stenosis. Off-label use of commercially available software was used to measure transesophageal 3DE volumes. Pre-TAVR annular linear dimensions included two-dimensional echocardiographic sagittal diameter and 3DE measurements of minimal diameter, maximal diameter (MaxDiam), and the average or mean diameter. Three-dimensional echocardiographic average annular diameter derived from annular perimeter (AveAnnDiamP) and average annular diameter derived from annular area (AveAnnDiamA) were calculated. A cover index was calculated using each measurement. Short-axis PVR color jet areas were summed after deployment and at the end of study. RESULTS: Two-dimensional echocardiographic sagittal diameter was significantly smaller than 3DE MaxDiam (P < .0001) and AveAnnDiamP (P = .017), significantly larger than 3DE minimal diameter (P < .0001), and not significantly different from 3DE mean diameter (P = .36) and AveAnnDiamA (P = .38). There was a linear relationship between all 3DE annular measurements and immediate post-TAVR PVR area (P = .0001), with the largest R(2) value (0.48) for 3DE MaxDiam, 3DE AveAnnDiamP, and 3DE AveAnnDiamA. The largest areas under the curve to detect greater than mild PVR were for 3DE AveAnnDiamP cover index (0.772) and 3DE AveAnnDiamA cover index (0.769). Intraclass correlation coefficients for interobserver and intraobserver variability were high for 3DE AveAnnDiamP and 3DE AveAnnDiamA and lower for 3DE MaxDiam. CONCLUSIONS: Using a novel approach to 3DE annular measurements, 3DE AveAnnDiamP and 3DE AveAnnDiamA can be reliably measured and correlate best with post-TAVR PVR area. New sizing algorithms with 3DE measurements should be developed.
PMID: 23998695
ISSN: 0894-7317
CID: 1066992
Predictors of Mortality and Outcomes of Therapy in Low-Flow Severe Aortic Stenosis: A Placement of Aortic Transcatheter Valves (PARTNER) Trial Analysis
Herrmann, Howard C; Pibarot, Philippe; Hueter, Irene; Gertz, Zachary M; Stewart, William J; Kapadia, Samir; Tuzcu, E Murat; Babaliaros, Vasilis; Thourani, Vinod; Szeto, Wilson Y; Bavaria, Joseph E; Kodali, Susheel; Hahn, Rebecca T; Williams, Mathew; Miller, D Craig; Douglas, Pamela S; Leon, Martin B
BACKGROUND: The prognosis and treatment of patients with low-flow (LF) severe aortic stenosis are controversial. METHODS AND RESULTS: The Placement of Aortic Transcatheter Valves (PARTNER) trial randomized patients with severe aortic stenosis to medical management versus transcatheter aortic valve replacement (TAVR; inoperable cohort) and surgical aortic valve replacement versus TAVR (high-risk cohort). Among 971 patients with evaluable echocardiograms (92%), LF (stroke volume index =35 mL/m(2)) was observed in 530 (55%); LF and low ejection fraction (<50%) in 225 (23%); and LF, low ejection fraction, and low mean gradient (<40 mm Hg) in 147 (15%). Two-year mortality was significantly higher in patients with LF compared with those with normal stroke volume index (47% versus 34%; hazard ratio, 1.5; 95% confidence interval, 1.25-1.89; P=0.006). In the inoperable cohort, patients with LF had higher mortality than those with normal flow, but both groups improved with TAVR (46% versus 76% with LF and 38% versus 53% with normal flow; P<0.001). In the high-risk cohort, there was no difference between TAVR and surgical aortic valve replacement. In patients with paradoxical LF and low gradient (preserved ejection fraction), TAVR reduced 1-year mortality from 66% to 35% (hazard ratio, 0.38; P=0.02). LF was an independent predictor of mortality in all patient cohorts (hazard ratio, approximately 1.5), whereas ejection fraction and gradient were not. CONCLUSIONS: LF is common in severe aortic stenosis and independently predicts mortality. Survival is improved with TAVR compared with medical management and similar with TAVR and surgical aortic valve replacement. A measure of flow (stroke volume index) should be included in the evaluation and therapeutic decision making of patients with severe aortic stenosis. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrial.gov. Unique identifier: NCT0053089.4.
PMID: 23661722
ISSN: 0009-7322
CID: 408632
Risk of stroke with percutaneous coronary intervention compared with on-pump and off-pump coronary artery bypass graft surgery: Evidence from a comprehensive network meta-analysis
Palmerini, Tullio; Biondi-Zoccai, Giuseppe; Riva, Diego Della; Mariani, Andrea; Savini, Carlo; Di Eusanio, Marco; Genereux, Philippe; Frati, Giacomo; Marullo, Antonino G M; Landoni, Giovanni; Greco, Teresa; Branzi, Angelo; De Servi, Stefano; Di Credico, Germano; Taglieri, Nevio; Williams, Mathew R; Stone, Gregg W
BACKGROUND: Although some trials have reported that on-pump coronary artery bypass graft (CABG) surgery may be associated with higher rates of stroke than percutaneous coronary intervention (PCI), whether stroke is more common after off-pump CABG compared with PCI is unknown. We therefore sought to determine whether off-pump CABG is associated with an increased risk of stroke compared with PCI by means of network meta-analysis. METHODS: Randomized controlled trials (RCTs) comparing CABG vs PCI were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. RESULTS: Eighty-three RCTs with 22,729 patients randomized to on-pump CABG (n = 10,957), off-pump CABG (n = 7,119), or PCI (n = 4,653) were analyzed. Thirty-day rates of stroke were significantly lower in patients treated with PCI compared with either off-pump CABG (odds ratio [OR]; 0.39, 95% CI, 0.19-0.83) or on-pump CABG (OR, 0.26; 95% CI, 0.12-0.47). Compared with on-pump CABG, off-pump CABG was associated with significantly lower 30-day risk of stroke (OR, 0.67; 95% CI, 0.41-0.95). However, in sensitivity analyses restricted to high-quality studies, studies with more than either 100 or 1,000 patients, or studies with protocol definition or adjudication of stroke by a clinical events committee, the precision of the point estimate for the 30-day risk of stroke between off-pump vs on-pump CABG was markedly reduced. CONCLUSIONS: Percutaneous coronary intervention is associated with lower 30-day rates of stroke than both off-pump and on-pump CABG. Further studies are required to determine whether the risk of stroke is reduced with off-pump CABG compared with on-pump CABG.
PMID: 23708161
ISSN: 0002-8703
CID: 1067002
Aortic valve and ascending aorta guidelines for management and quality measures
Svensson, Lars G; Adams, David H; Bonow, Robert O; Kouchoukos, Nicholas T; Miller, D Craig; O'Gara, Patrick T; Shahian, David M; Schaff, Hartzell V; Akins, Cary W; Bavaria, Joseph E; Blackstone, Eugene H; David, Tirone E; Desai, Nimesh D; Dewey, Todd M; D'Agostino, Richard S; Gleason, Thomas G; Harrington, Katherine B; Kodali, Susheel; Kapadia, Samir; Leon, Martin B; Lima, Brian; Lytle, Bruce W; Mack, Michael J; Reardon, Michael; Reece, T Brett; Reiss, G Russell; Roselli, Eric E; Smith, Craig R; Thourani, Vinod H; Tuzcu, E Murat; Webb, John; Williams, Mathew R
PMID: 23688839
ISSN: 0003-4975
CID: 1067012
Decision-making in transcatheter aortic valve replacement: the impact of frailty in older adults with aortic stenosis
Wong, Catherine Y; Green, Philip; Williams, Mathew
Patients with severe aortic stenosis are commonly elderly and with significant comorbidity. Surgical intervention can improve symptoms and survival in severe aortic stenosis. However, a large proportion of patients do not undergo surgical intervention because they are deemed to be inoperable or too high risk. Over the last decade, transcatheter aortic valve replacement (TAVR) has been developed, providing an effective, less-invasive alternative to open cardiac surgery for inoperable or high-risk patients. The purpose of this review is to provide an overview of risk assessment in TAVR. Specifically, this article reviews the epidemiology of aortic stenosis, describes the risks and benefits of TAVR across multiple outcome measures, explores frailty and other elderly risk factors as metrics for improved risk assessment and discusses the application of improved risk assessment in TAVR decisions.
PMID: 23750685
ISSN: 1744-8344
CID: 5367812
Expandable external support device to improve Saphenous Vein Graft Patency after CABG
Ben-Gal, Yanai; Taggart, David P; Williams, Mathew R; Orion, Eyal; Uretzky, Gideon; Shofti, Rona; Banai, Shmuel; Yosef, Liad; Bolotin, Gil
Objectives: Low patency rates of saphenous vein grafts remain a major predicament in surgical revascularization. We examined a novel expandable external support device designed to mitigate causative factors for early and late graft failure. METHODS: For this study, fourteen adult sheep underwent cardiac revascularization using two vein grafts for each; one to the LAD and the other to the obtuse marginal artery. One graft was supported with the device while the other served as a control. Target vessel was alternated between consecutive cases. The animals underwent immediate and late angiography and were then sacrificed for histopathologic evaluation. RESULTS: Of the fourteen animals studied, three died peri-operatively (unrelated to device implanted), and ten survived the follow-up period. Among surviving animals, three grafts were thrombosed and one was occluded, all in the control group (p = 0.043). Quantitative angiographic evaluation revealed no difference between groups in immediate level of graft uniformity, with a coefficient-of-variance (CV%) of 7.39 in control versus 5.07 in the supported grafts, p = 0.082. At 12 weeks, there was a significant non-uniformity in the control grafts versus the supported grafts (CV = 22.12 versus 3.01, p < 0.002). In histopathologic evaluation, mean intimal area of the supported grafts was significantly lower than in the control grafts (11.2 mm^2 versus 23.1 mm^2 p < 0.02). CONCLUSIONS: The expandable SVG external support system was found to be efficacious in reducing SVG's non-uniform dilatation and neointimal formation in an animal model early after CABG. This novel technology may have the potential to improve SVG patency rates after surgical myocardial revascularization.
PMCID:3661403
PMID: 23641948
ISSN: 1749-8090
CID: 1067022