Martin B Leon

CUNY Graduate Center, New York, New York, United States

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Publications (805)7258.19 Total impact

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    ABSTRACT: The long-term risk associated with different coronary artery disease (CAD) presentations in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is poorly characterized. We pooled patient-level data for women enrolled in 26 randomized clinical trials. Out of 11,577 women included in the pooled database, 10,133 with known clinical presentation received a DES. Of them, 5760 (57%) had stable angina pectoris (SAP), 3594 (35%) had unstable angina pectoris (UAP) or NSTEMI and 779 (8%) had STEMI as clinical presentation. A stepwise increase in 3-year crude cumulative mortality was observed in the transition from SAP to STEMI (4.9% vs. 6.1% vs. 9.4%; p < 0.01). Conversely, no differences in crude mortality rates were observed between 1 and 3 years across clinical presentations. Following multivariable adjustment, STEMI was independently associated with higher risk of 3-year mortality (HR: 3.45; 95% CI: 1.99 - 5.98; p < 0.01), while no differences were observed between UAP or NSTEMI and SAP (HR: 0.99; 95% CI: 0.73 - 1.34; p = 0.94). In women with ACS, use of new-generation DES was associated with reduced risk of major adverse cardiac events (HR: 0.58; 0.34 - 0.98). The magnitude and direction of the effect with new-generation DES was uniform between women with or without ACS (p for interaction = 0.66). In conclusion, in women across the clinical spectrum of CAD, STEMI was associated with a higher risk of long-term mortality. Conversely, the adjusted risk of mortality between UAP or NSTEMI and SAP was similar. New-generation DESs provide improved long-term clinical outcomes irrespective of the clinical presentation in women.
    The American Journal of Cardiology 09/2015;
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    ABSTRACT: In the Placement of AoRTic TraNscathetER Valve (PARTNER) randomized controlled trial (RCT), which represented the first exposure to transapical transcatheter aortic valve replacement (TA-TAVR) for many clinical sites, high-risk patients undergoing TA-TAVR derived similar health-related quality of life (HRQoL) outcomes when compared with surgical aortic valve replacement (SAVR). With increasing experience, it is possible that HRQoL outcomes of TA-TAVR may have improved. We evaluated HRQoL outcomes at 1-, 6-, and 12-month follow-ups among 875 patients undergoing TA-TAVR in the PARTNER nonrandomized continued access (NRCA) registry and compared these outcomes with those of the TA-TAVR and SAVR patients in the PARTNER RCT. HRQoL was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short-Form 12, and the EuroQoL-5D, with the KCCQ overall summary score serving as the primary end point. The NRCA TA-TAVR and RCT TA-TAVR and SAVR groups were generally similar. The primary outcome, the KCCQ summary score, did not differ between the NRCA TA-TAVR and the RCT TA-TAVR group at any follow-up timepoints, although there were small differences in favor of the NRCA cohort on several KCCQ subscales at 1 month. There were no significant differences in follow-up HRQOL between the NRCA-TAVR and the RCT SAVR cohorts on the KCCQ overall summary scale or any of the disease-specific or generic subscales. Despite greater experience with TA-TAVR in the NRCA registry, HRQoL outcomes remained similar to those of TA-TAVR in the original RCT cohort and no better than those with SAVR. These findings have important implications for patient selection for TAVR when transfemoral access is not an option. URL: Unique identifier: NCT00530894. © 2015 American Heart Association, Inc.
    Circulation Cardiovascular Quality and Outcomes 06/2015; DOI:10.1161/CIRCOUTCOMES.114.001335
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    ABSTRACT: 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)). 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. 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). 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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to
    Heart (British Cardiac Society) 06/2015; DOI:10.1136/heartjnl-2014-307120
  • EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 05/2015; 11(V):V145-V146. DOI:10.4244/EIJV11SVA33
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    ABSTRACT: The renal nerves contribute to hypertension through effects in the kidney that enhance sodium retention and renin secretion, and by effects in the central nervous system that increase systemic sympathetic activity. Therefore, targeting the renal nerves provides a logical basis for treating hypertension. Several trials of renal denervation--achieved by applying radiofrequency energy through catheters placed in the renal arteries-- have been completed. Clinical results have been inconsistent, however, partly because of factors related to the ablation technique and partly because these studies have been performed in patients with the inadequately defined clinical condition of "treatment-resistant hypertension." This statement now explains our conclusion that future studies of renal denervation should be guided by the established randomized, controlled clinical trial designs used for studying antihypertensive drugs and other treatments for hypertension. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.
    Journal of Clinical Hypertension 05/2015; DOI:10.1111/jch.12590
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    ABSTRACT: Three-dimensional (3D) quantitative coronary angiography (QCA) provides more accurate measurements by minimizing inherent limitations of two-dimensional (2D) QCA. The aim of this study was to compare the measurements between 2D and 3D QCA analyses in bifurcation lesions. A total of 114 cases with non-left main bifurcation lesions in the TRYTON pivotal IDE Coronary Bifurcation Trial ( NCT01258972) were analyzed using a validated bifurcation QCA software (CAAS 5.10, Pie Medical Imaging, Maastricht, the Netherlands). All cases were analyzed in matched projections between pre- and post-procedure. The 2D analysis was performed using one of two angiographic images used for 3D reconstruction showing a larger distal bifurcation angle. In the treated segments (stent and balloon), there were no differences in minimal luminal diameter (MLD) between 2D and 3D, while diameter stenosis (DS) was significantly higher in 2D compared to 3D both pre-procedure and post-procedure (53.9% for 2D vs. 52.1% for 3D pre-procedure, P < 0.01; 23.2% for 2D vs. 20.9% for 3D post-procedure, P = 0.01). In the sub-segment level analysis, lengths of proximal main branch, distal main branch, and side branch were consistently shorter in 2D compared to 3D both pre-procedure and post-procedure. Using 3D QCA, the anatomic location of the smallest MLD or the highest DS was relocated to a different bifurcation sub-segment in a considerable proportion of the patients compared to when 2D-QCA was used (kappa values: 0.50 for MLD, 0.55 for DS). Our data showed differences in addressing anatomical severity and location of coronary bifurcation lesions between in vivo 2D and 3D QCA analyses. More studies are needed to investigate potential clinical benefits in using 3D approach over 2D QCA for the assessment of bifurcation lesions. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.
    Catheterization and Cardiovascular Interventions 04/2015; DOI:10.1002/ccd.25925
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    ABSTRACT: Transcatheter mitral interventions has been developed to address an unmet clinical need and may be an alternative therapeutic option to surgery with the intent to provide symptomatic and prognostic benefit. Beyond MitraClip therapy, alternative repair technologies are being developed to expand the transcatheter intervention armamentarium. Recently, the feasibility of transcatheter mitral valve implantation in native non-calcified valves has been reported in very high-risk patients. Acknowledging the lack of scientific evidence to date, it is difficult to predict what the ultimate future role of transcatheter mitral valve interventions will be. The purpose of the present report is to review the current state-of-the-art of mitral valve intervention, and to identify the potential future scenarios, which might benefit most from the transcatheter repair and replacement devices under development. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email:
    European Heart Journal 04/2015; DOI:10.1093/eurheartj/ehv123
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    ABSTRACT: Results of the SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial confirmed the safety but not the efficacy of renal denervation for treatment-resistant hypertension at 6 months post procedure. This study sought to analyze the 12-month SYMPLICITY HTN-3 results for the original denervation group, the sham subjects who underwent denervation after the 6-month endpoint (crossover group), and the sham subjects who did not undergo denervation after 6 months (non-crossover group). Eligible subjects were randomized 2:1 to denervation or sham procedure. Subjects were unblinded to their treatment group after the 6-month primary endpoint was ascertained; subjects in the sham group meeting eligibility requirements could undergo denervation. Change in blood pressure (BP) at 12 months post randomization (6 months for crossover subjects) was analyzed. The 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects; 6-month denervation follow-up was available for 93 of 101 crossover subjects. In denervation subjects, the 12-month office systolic BP (SBP) change was greater than that observed at 6 months (-15.5 ± 24.1 mm Hg vs. -18.9 ± 25.4 mm Hg, respectively; p = 0.025), but the 24-h SBP change was not significantly different at 12 months (p = 0.229). The non-crossover group office SBP decreased by -32.9 ± 28.1 mm Hg at 6 months, but this response regressed to -21.4 ± 19.9 mm Hg (p = 0.01) at 12 months, increasing to 11.5 ± 29.8 mm Hg. These data support no further reduction in office or ambulatory BP after 1-year follow-up. Loss of BP reduction in the non-crossover group may reflect decreased medication adherence or other related factors. (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
    Journal of the American College of Cardiology 04/2015; 65(13):1314-21. DOI:10.1016/j.jacc.2015.01.037
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    ABSTRACT: Significant mitral regurgitation (MR) constitutes an important co-existing valvular heart disease burden in the setting of aortic valve stenosis. There are conflicting reports on the impact of significant MR on outcomes after transcatheter aortic valve implantation (TAVI). We evaluated the impact of MR on outcomes after TAVI by performing a meta-analysis of 8 studies involving 8,927 patients reporting TAVI outcomes based on the presence or absence of moderate-severe MR. Risk ratios (RRs) were calculated using the inverse variance random-effects model. None-mild MR was present in 77.8% and moderate-severe MR in 22.2% of the patients. The presence of moderate-severe MR at baseline was associated with increased mortality at 30 days (RR 1.35, 95% confidence interval [CI] 1.14 to 1.59, p = 0.003) and 1 year (RR 1.24, 95% CI 1.13 to 1.37, p <0.0001). The increased mortality associated with moderate-severe MR was not influenced by the cause of MR (functional or degenerative MR; RR 0.90, 95% CI 0.62 to 1.30, p = 0.56). The severity of MR improved in 61 ± 6.0% of patients after TAVI. Moderate-severe residual MR, compared with none-mild residual MR after TAVI, was associated with significantly increased 1-year mortality (RR 1.48, 95% CI 1.31 to 1.68, p <0.00001). In conclusion, baseline moderate-severe MR and significant residual MR after TAVI are associated with an increase in mortality after TAVI and represent an important group to target with medical or transcatheter therapies in the future. Copyright © 2015 Elsevier Inc. All rights reserved.
    The American Journal of Cardiology 04/2015; 115(7). DOI:10.1016/j.amjcard.2015.01.022
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    ABSTRACT: Valve thrombosis has yet to be fully evaluated after transcatheter aortic valve implantation. This study aimed to report the prevalence, timing, and treatment of transcatheter heart valve (THV) thrombosis. THV thrombosis was defined as follows (1) THV dysfunction secondary to thrombosis diagnosed based on response to anticoagulation therapy, imaging modality or histopathology findings, or (2) mobile mass detected on THV suspicious of thrombus, irrespective of dysfunction and in absence of infection. Between January 2008 and September 2013, 26 (0.61%) THV thromboses were reported out of 4266 patients undergoing transcatheter aortic valve implantation in 12 centers. Of the 26 cases detected, 20 were detected in the Edwards Sapien/Sapien XT cohort and 6 in the Medtronic CoreValve cohort. In patients diagnosed with THV thrombosis, the median time to THV thrombosis post-transcatheter aortic valve implantation was 181 days (interquartile range, 45-313). The most common clinical presentation was exertional dyspnea (n=17; 65%), whereas 8 (31%) patients had no worsening symptoms. Echocardiographic findings included a markedly elevated mean aortic valve pressure gradient (40.5±14.0 mm Hg), presence of thickened leaflets or thrombotic apposition of leaflets in 20 (77%) and a thrombotic mass on the leaflets in the remaining 6 (23%) patients. In 23 (88%) patients, anticoagulation resulted in a significant decrease of the aortic valve pressure gradient within 2 months. THV thrombosis is a rare phenomenon that was detected within the first 2 years after transcatheter aortic valve implantation and usually presented with dyspnea and increased gradients. Anticoagulation seems to have been effective and should be considered even in patients without visible thrombus on echocardiography. © 2015 American Heart Association, Inc.
    Circulation Cardiovascular Interventions 04/2015; 8(4). DOI:10.1161/CIRCINTERVENTIONS.114.001779
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    ABSTRACT: -Higher risk of adverse outcomes after transapical (TA) vs. transfemoral (TF) transcatheter aortic valve replacement (TAVR) could be due to TA-TAVR being an open surgical procedure or to clinical differences between TA- and TF-TAVR patients. We compared outcomes after neutralizing patient differences using propensity-score matching. -From 4/2007-2/2012, 1100 PARTNER-I patients underwent TA-TAVR and 1521 TF-TAVR using Edwards SAPIEN balloon-expandable bioprostheses. Propensity matching based on 111 pre-procedural variables, exclusive of femoral access morphology, identified 501 well-matched patient pairs (46% of possible matches), 95% of whom had peripheral arterial disease. Matched TA-TAVR patients experienced more adverse procedural events, longer length of stay (5 vs. 8 days, p<0.0001), and slower recovery (New York Heart Association class I 31% vs. 38% at 30 days, equalizing by 6 months at 51% vs. 47%); stroke risk was similar (3.4% vs. 3.3% at 30 days and 6.0% vs. 6.7% at 3 years); mortality was elevated for the first 6 post-procedure months (19% vs. 12%, p=0.01), but aortic regurgitation was less (34% vs. 52% mild and 8.9% vs. 12% moderate-severe at discharge, p=0.001; 36% vs. 50% mild and 10% vs. 15% moderate-severe at 6 months, p<0.0001). -Likelihood of adverse periprocedural events and prolonged recovery is greater after TA-TAVR than TF-TAVR in vasculopathic patients after accounting for differences in cardiovascular risk factors, although stroke risk is equivalent and aortic regurgitation less. As smaller delivery systems permit TF-TAVR in many of these patients, we recommend a TF-first access strategy for TAVR when anatomically feasible. Clinical Trial Identifier: NCT00530894.
    Circulation 04/2015; 131(22). DOI:10.1161/CIRCULATIONAHA.114.012525
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    ABSTRACT: Tricuspid regurgitation (TR) and right ventricular (RV) dysfunction adversely affect outcomes in patients with heart failure or mitral valve disease, but their impact on outcomes in patients with aortic stenosis treated with transcatheter aortic valve replacement has not been well characterized. Among 542 patients with symptomatic aortic stenosis treated in the Placement of Aortic Transcatheter Valves (PARTNER) II trial (inoperable cohort) with a Sapien or Sapien XT valve via a transfemoral approach, baseline TR severity, right atrial and RV size and RV function were evaluated by echocardiography according to established guidelines. One-year mortality was 16.9%, 17.2%, 32.6%, and 61.1% for patients with no/trace (n=167), mild (n=205), moderate (n=117), and severe (n=18) TR, respectively (P<0.001). Increasing severity of RV dysfunction as well as right atrial and RV enlargement were also associated with increased mortality (P<0.001). After multivariable adjustment, severe TR (hazard ratio, 3.20; 95% confidence interval, 1.50-6.82; P=0.003) and moderate TR (hazard ratio, 1.60; 95% confidence interval, 1.02-2.52; P=0.042) remained associated with increased mortality as did right atrial and RV enlargement, but not RV dysfunction. There was an interaction between TR and mitral regurgitation severity (P=0.04); the increased hazard of death associated with moderate/severe TR only occurred in those with no/trace/mild mitral regurgitation. In inoperable patients treated with transcatheter aortic valve replacement, moderate or severe TR and right heart enlargement are independently associated with increased 1-year mortality; however, the association between moderate or severe TR and an increased hazard of death was only found in those with minimal mitral regurgitation at baseline. These findings may improve our assessment of anticipated benefit from transcatheter aortic valve replacement and support the need for future studies on TR and the right heart, including whether concomitant treatment of TR in operable but high-risk patients with aortic stenosis is warranted. URL: Unique identifier: NCT01314313. © 2015 American Heart Association, Inc.
    Circulation Cardiovascular Interventions 04/2015; 8(4). DOI:10.1161/CIRCINTERVENTIONS.114.002073
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    ABSTRACT: Transcatheter aortic valve replacement (TAVR) is an effective treatment for severe symptomatic aortic stenosis (AS) in patients who are inoperable or at high risk for surgery. However, the intermediate- to long-term mortality is high, emphasizing the importance of patient selection. We, therefore, sought to evaluate the prognostic value of frailty in older recipients of TAVR, hypothesizing that frail patients would experience a higher mortality rate and a higher likelihood of poor outcome 1 year after TAVR. This substudy of the Placement of Aortic Transcatheter Valves trial was conducted at 3 high-enrolling sites where frailty was assessed systematically before TAVR. In total, 244 patients received TAVR at the participating sites. Frailty was assessed using a composite of 4 markers (serum albumin, dominant handgrip strength, gait speed, and Katz activity of daily living survey), which were combined into a frailty score. The cohort was dichotomized at median frailty score. Outcomes measures were the time to death from any cause for >1 year of follow-up and poor outcome at 1 year. Poor outcome was defined as (1) death, (2) Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score <60, or (3) decrease of ≥10 points in the KCCQ-OS score from baseline to 1 year. At 1 year, the Kaplan-Meier-estimated all-cause mortality rate was 32.7% in the frail group and 15.9% in the nonfrail group (log-rank p = 0.004). At 1 year, poor outcome occurred in 50.0% of the frail group and 31.5% of the nonfrail group (p = 0.02). In conclusion, frailty was associated with increased mortality and a higher rate of poor outcome 1 year after TAVR. Copyright © 2015 Elsevier Inc. All rights reserved.
    The American Journal of Cardiology 04/2015; DOI:10.1016/j.amjcard.2015.03.061
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    ABSTRACT: Transcatheter aortic valve replacement (TAVR) using a balloon-expandable valve is an accepted alternative to surgical replacement for severe, symptomatic aortic stenosis in high risk or inoperable patients. Intraprocedural transesophageal echocardiography (TEE) offers real-time imaging guidance throughout the procedure and allows for rapid and accurate assessment of complications and procedural results. The value of intraprocedural TEE for TAVR will likely increase in the future as this procedure is performed in lower surgical risk patients, who also have lower risk for general anesthesia, but a greater expectation of optimal results with lower morbidity and mortality. This imaging compendium from the PARTNER (Placement of Aortic Transcatheter Valves) trials is intended to be a comprehensive compilation of intraprocedural complications imaged by intraprocedural TEE and diagnostic tools to anticipate and/or prevent their occurrence. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
    JACC Cardiovascular Imaging 03/2015; 8(3). DOI:10.1016/j.jcmg.2014.12.013
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    ABSTRACT: Randomized controlled trials comparing short- (≤6 months) with long-term (≥1 year) dual antiplatelet therapy (DAPT) after drug-eluting stent(s) (DES) placement have been insufficiently powered to detect significant differences in the risk of major adverse cardiac events (MACE). This study sought to compare clinical outcomes between short- (≤6 months) and long-term (1 year) DAPT and among 3 months, 6 months, and 1 year of DAPT post-DES placement by performing an individual patient data pairwise and network meta-analysis. Randomized controlled trials comparing DAPT durations after DES placement were searched through the MEDLINE, EMBASE, and Cochrane databases and in international meeting proceedings. The primary study outcome was 1-year risk of MACE (cardiac death, myocardial infarction, or definite/probable stent thrombosis). Four trials including 8,180 randomized patients were identified. At 1-year follow-up, short-term DAPT was associated with similar rates of MACE (hazard ratio [HR]: 1.11; 95% confidence interval [CI]: 0.86 to 1.43; p = 0.44), but significantly lower rates of bleeding (HR: 0.66; 95% CI: 0.46 to 0.94; p = 0.03) versus prolonged DAPT. Comparable results were apparent in the landmark period between DAPT discontinuation and 1-year follow-up (for MACE: HR: 1.20; 95% CI: 0.77 to 1.89; p = 0.42) (for bleeding: HR: 0.44; 95% CI: 0.21 to 0.91; p = 0.03). There were no significant differences in 1-year rates of MACE among 3-month versus 1-year DAPT, 6-month versus 1-year DAPT, or 3-month versus 6-month DAPT. Compared with prolonged DAPT, short-term DAPT is associated with similar rates of MACE but lower rates of bleeding after DES placement. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
    Journal of the American College of Cardiology 03/2015; 65(11). DOI:10.1016/j.jacc.2014.12.046
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    ABSTRACT: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that mortality at 1 year, 2 years, and 3 years is much the same with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) for high-risk patients with aortic stenosis. We report here the 5-year outcomes. We did this randomised controlled trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23). We used a computer-generated randomisation sequence to randomly assign high-risk patients with severe aortic stenosis to either SAVR or TAVR with a balloon-expandable bovine pericardial tissue valve by either a transfemoral or transapical approach. Patients and their treating physicians were not masked to treatment allocation. The primary outcome of the trial was all-cause mortality in the intention-to-treat population at 1 year, we present here predefined outcomes at 5 years. The study is registered with, number NCT00530894. We screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR, 351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 11·7%. At 5 years, risk of death was 67·8% in the TAVR group compared with 62·4% in the SAVR group (hazard ratio 1·04, 95% CI 0·86-1·24; p=0·76). We recorded no structural valve deterioration requiring surgical valve replacement in either group. Moderate or severe aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR group and two (1%) of 228 in the SAVR group (p<0·0001), and was associated with increased 5-year risk of mortality in the TAVR group (72·4% for moderate or severe aortic regurgitation vs 56·6% for those with mild aortic regurgitation or less; p=0·003). Our findings show that TAVR as an alternative to surgery for patients with high surgical risk results in similar clinical outcomes. Edwards Lifesciences. Copyright © 2015 Elsevier Ltd. All rights reserved.
    The Lancet 03/2015; DOI:10.1016/S0140-6736(15)60308-7
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    ABSTRACT: Based on the early results of the Placement of Aortic Transcatheter Valves (PARTNER) trial, transcatheter aortic valve replacement (TAVR) is an accepted treatment for patients with severe aortic stenosis who are not suitable for surgery. However, little information is available about the late clinical outcomes in such patients. We did this randomised controlled trial at 21 experienced valve centres in Canada, Germany, and the USA. We enrolled patients with severe symptomatic inoperable aortic stenosis and randomly assigned (1:1) them to transfemoral TAVR or to standard treatment, which often included balloon aortic valvuloplasty. Patients and their treating physicians were not masked to treatment allocation. The randomisation was done centrally, and sites learned of the assignment only after a patient had been screened, consented, and entered into the database. The primary outcome of the trial was all-cause mortality at 1 year in the intention-to-treat population, here we present the prespecified findings after 5 years. This study is registered with, number NCT00530894. We screened 3015 patients, of whom 358 were enrolled (mean age 83 years, Society of Thoracic Surgeons Predicted Risk of Mortality 11·7%, 54% female). 179 were assigned to TAVR treatment and 179 were assigned to standard treatment. 20 patients crossed over from the standard treatment group and ten withdrew from study, leaving only six patients at 5 years, of whom five had aortic valve replacement treatment outside of the study. The risk of all-cause mortality at 5 years was 71·8% in the TAVR group versus 93·6% in the standard treatment group (hazard ratio 0·50, 95% CI 0·39-0·65; p<0·0001). At 5 years, 42 (86%) of 49 survivors in the TAVR group had New York Heart Association class 1 or 2 symptoms compared with three (60%) of five in the standard treatment group. Echocardiography after TAVR showed durable haemodynamic benefit (aortic valve area 1·52 cm(2) at 5 years, mean gradient 10·6 mm Hg at 5 years), with no evidence of structural valve deterioration. TAVR is more beneficial than standard treatment for treatment of inoperable aortic stenosis. TAVR should be strongly considered for patients who are not surgical candidates for aortic valve replacement to improve their survival and functional status. Appropriate selection of patients will help to maximise the benefit of TAVR and reduce mortality from severe comorbidities. Edwards Lifesciences. Copyright © 2015 Elsevier Ltd. All rights reserved.
    The Lancet 03/2015; 385(9986). DOI:10.1016/S0140-6736(15)60290-2
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    ABSTRACT: -We aimed to determine the incidence, predictors, clinical characteristics, management, and outcomes of IE after TAVI. -This multicenter registry included 53 patients (mean age 79±8 years, men: 57%) who suffered IE following TAVI of 7,944 patients after a mean follow-up of 1.1±1.2 years (incidence of 0.67%; 0.50% within the first year post-TAVI). Mean time from TAVI was 6 (IQR: 1-14) months. Orotracheal intubation (HR: 3.87, 95%CI: 1.55-9.64, P=.004) and the self-expandable CoreValve system (HR: 3.12, 95% CI: 1.37-7.14, P=.007) were associated with IE (multivariate analysis including 3067 patients with individual data). The most frequent causal microorganisms were coagulase-negative staphylococci (24%), followed by Staphylococcus aureus (21%) and enterococci (21%). Vegetations were present in 77% of patients (transcatheter valve leaflets: 39%, stent frame: 17%, mitral valve: 21%). At least one complication of IE occurred in 87% of patients (heart failure in 68%). However, only 11% of patients underwent valve intervention (valve explantation and valve-in-valve in 4 and 2 patients, respectively). The in-hospital mortality rate was 47.2%, and increased up to 66% at 1-year follow-up. IE complications such as heart failure (p=0.037) or septic shock (p=0.002) were associated with increased in-hospital mortality. -The incidence of IE at 1-year after TAVI was of 0.50%, and the risk increased with the use of orotracheal intubation and a self-expandable valve system. Staphyloccoci and enteroccoci were the most common agents. While most patients presented at least one complication of IE, valve intervention was performed in a minority of patients, and nearly half of the patients died during the hospitalization period.
    Circulation 03/2015; 131(18). DOI:10.1161/CIRCULATIONAHA.114.014089
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    ABSTRACT: This study sought to compare the influence of the extent of multidetector computed tomography (MDCT) area oversizing on the incidence of paravalvular aortic regurgitation (PAR) between the Sapien 3 and the Sapien XT transcatheter heart valve (THV) to define a new MDCT sizing guideline suitable for the Sapien 3 platform. The inverse relationship of PAR occurrence and oversizing has been demonstrated for the Sapien XT but the incidence of PAR with comparable oversizing with the Sapien 3 is not known. Sixty-one prospectively enrolled patients who underwent transcatheter aortic valve replacement with the Sapien 3 THV were compared with 92 patients who underwent transcatheter aortic valve replacement with the Sapien XT THV. Patients were categorized depending on the degree of MDCT area oversizing percentage: undersizing (below 0%), 0% to 5%, 5% to 10%, and above 10%. The primary endpoint was mild or greater PAR on transthoracic echocardiography. Mild or greater PAR was present in 19.7% of patients (12 of 61) in the Sapien 3 group and in 54.3% of patients (50 of 92) in the Sapien XT group (p < 0.01). The Sapien 3 group, compared with the Sapien XT group, consistently demonstrated significantly lower rates of mild or greater PAR except for oversizing >10% (p for interaction = 0.54). Moderate or severe PAR rates were also lower in the Sapien 3 group than in the Sapien XT group (3.3% vs. 13.0%, p = 0.04). In the Sapien 3 group, a MDCT area oversizing percentage value of ≤4.17% was identified as the optimal cutoff value to discriminate patients with or without mild or greater PAR. Our retrospective analysis suggests that the Sapien 3 THV displays significantly lower rates of PAR than does the Sapien XT THV. A lesser degree of MDCT area oversizing may be employed for this new balloon-expandable THV. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
    JACC. Cardiovascular Interventions 03/2015; 8(3):462-71. DOI:10.1016/j.jcin.2014.10.014

Publication Stats

41k Citations
7,258.19 Total Impact Points


  • 2005–2015
    • CUNY Graduate Center
      New York, New York, United States
    • New York Presbyterian Hospital
      • Department of Cardiology
      New York, New York, United States
    • Chiba University
      Tiba, Chiba, Japan
  • 2004–2015
    • Columbia University
      • • Division of Cardiology
      • • Department of Medicine
      New York, New York, United States
    • PinnacleHealth Harrisburg Hospital in Harrisburg
      Harrisburg, Pennsylvania, United States
    • Deutsches Herzzentrum München
      München, Bavaria, Germany
    • St. Mary Medical Center
      Long Beach, California, United States
    • Methodist Hospitals
      Gary, Indiana, United States
    • Brigham and Women's Hospital
      Boston, Massachusetts, United States
  • 1999–2015
    • Cardiovascular Research Foundation
      New York, New York, United States
    • The Washington Hospital
      Washington, Pennsylvania, United States
  • 2014
    • Stanford Medicine
      Stanford, California, United States
  • 2013
    • Durham University
      Durham, England, United Kingdom
    • Cleveland Clinic
      Cleveland, Ohio, United States
    • Inselspital, Universitätsspital Bern
      Berna, Bern, Switzerland
    • University of Catania
      Catania, Sicily, Italy
  • 2006–2013
    • Mid-Columbia Medical Center
      DLS, Oregon, United States
  • 2012
    • Mount Sinai Medical Center
      New York City, New York, United States
    • Erasmus Universiteit Rotterdam
      Rotterdam, South Holland, Netherlands
  • 2003–2011
    • Gracie Square Hospital, New York, NY
      New York, New York, United States
  • 2007
    • University of Hamburg
      Hamburg, Hamburg, Germany
  • 2001–2006
    • Lenox Hill Hospital
      New York, New York, United States
  • 2002–2004
    • Harvard University
      Cambridge, Massachusetts, United States
    • Mayo Clinic - Rochester
      Rochester, Minnesota, United States
  • 1996–2004
    • Stanford University
      • Department of Surgery
      Palo Alto, California, United States
    • University of California, San Diego
      San Diego, California, United States
  • 1995–2003
    • William Beaumont Army Medical Center
      El Paso, Texas, United States
    • Ajou University
      Sŏul, Seoul, South Korea
  • 1991–2002
    • Washington Hospital Center
      Washington, Washington, D.C., United States
    • Yale-New Haven Hospital
      New Haven, Connecticut, United States
  • 1997–2001
    • Kokura Memorial Hospital
      Kitakyūshū, Fukuoka, Japan
  • 2000
    • Cornell University
      Итак, New York, United States
  • 1998–1999
    • Washington Research Foundation
      Seattle, Washington, United States
  • 1997–1999
    • University of Ulsan
      • • Department of Medicine
      • • College of Medicine
      Ulsan, Ulsan, South Korea
  • 1993–1997
    • Washington DC VA Medical Center
      Washington, Washington, D.C., United States
    • Jefferson College
      Хиллсборо, Missouri, United States
  • 1994
    • Emory University
      • Division of Cardiology
      Atlanta, Georgia, United States
  • 1981–1994
    • National Institutes of Health
      Maryland, United States
  • 1988–1992
    • National Heart, Lung, and Blood Institute
      • Hematology Branch
      Maryland, United States