Association Between Nonvitamin K Antagonist Oral Anticoagulants or Warfarin and Liver Injury: A Cohort Study.

INTRODUCTION: The risk of liver injury in patients with atrial fibrillation (AF) using nonvitamin K antagonist oral anticoagulants (NOACs) has not been previously examined using liver function tests as the primary outcome in the real-world setting. This study assessed the association between NOACs (dabigatran, rivaroxaban, and apixaban) and warfarin and the risk of liver injury, as defined by laboratory tests. METHODS: Patients newly diagnosed with AF and prescribed NOACs or warfarin between 2010 and 2016, identified using the Hong Kong Clinical Database and Reporting System, were matched on age, sex, health status scores, comorbidities, and medications by propensity score on a 1:1 ratio. Risk of liver injury, defined as laboratory test values >3 times the upper limit of normal of alanine aminotransferase or aspartate aminotransferase and >2 times the upper limit of normal of total bilirubin, was compared between NOAC and warfarin users using Cox proportional hazards regression. RESULTS: After propensity score matching, 13,698 patients were included, of which 141 (2.1%) NOAC users and 232 (3.4%) warfarin users developed liver injury. The hazard ratio (HR) for NOAC vs warfarin users was 0.71 (95% confidence interval: 0.58-0.89). When comparing individual NOACs, only dabigatran (hazard ratio: 0.63; 95% confidence interval: 0.48-0.82) was associated with a lower risk of liver injury. DISCUSSION: Among patients with AF, NOACs as a group, and dabigatran alone were associated with a significantly lower risk of laboratory-based liver injury when compared with warfarin. However, liver injury occurs more frequently in real-world practice than in NOAC randomized controlled trials.

Experimental observations of diurnal acoustic propagation effects in seagrass meadows on the Dongsha Atoll.

Large regions with seagrass meadows have been discovered on Dongsha Atoll located in the South China Sea. The aim of this study is the estimation of acoustic propagation loss in the frequency range of individual bubble resonance due to the gas content of seagrass in seagrass meadows. Specifically, this study seeks to (a) investigate the attenuation of the mid-frequency (2-8 kHz) signal induced by the gas content in a seagrass meadow and (b) present the diurnal variation of sound attenuation. The results demonstrate that >40 dB diurnal variations of mid-frequency propagation loss was observed in shallow seagrass meadow region.

Balloon aortic valvuloplasty via a bilateral trans-radial artery approach prior to transcatheter aortic valve replacement.

Balloon aortic valvuloplasty (BAV) intervention is used as destination therapy or as a bridge to percutaneous or surgical aortic valve intervention. BAV is traditionally performed via a transfemoral approach; however, this may not be feasible in all patients due to peripheral vascular disease. We present a case of BAV performed via bilateral transradial access utilizing simultaneous deployment of two angioplasty balloons.

Prevention of Dabigatran-Related Gastrointestinal Bleeding With Gastroprotective Agents: A Population-Based Study.

BACKGROUND & AIMS: Use of dabigatran, an inhibitor of thrombin, increases the risk of gastrointestinal bleeding (GIB). However, it is not clear whether gastroprotective agents (GPAs) prevent GIB in dabigatran users. We investigated the risk of GIB and the role of gastroprotective agents (including proton pump inhibitors and histamine type-2-receptor antagonists) in patients using dabigatran. METHODS: We performed a retrospective cohort study using a population-wide database managed by the Hong Kong Hospital Authority. Patients newly prescribed dabigatran from 2010 through 2013 were included in the analysis. Poisson regression was used to assess the risk of GIB in dabigatran users by incidence rate ratio (IRR), adjusted for patient characteristics, comorbidities, and concurrent medications. RESULTS: Among the 5041 patients newly prescribed dabigatran, 124 (2.5%) developed GIB during follow-up evaluation (4.2/100 patient-years). The risk of GIB in this population increased among patients 75 years and older (IRR, 2.47; 95% confidence interval [CI], 1.66-3.68), patients with a history of peptic ulcers or GIB (IRR, 2.31; 95% CI, 1.54-3.46), and patients who used aspirin (IRR, 1.52; 95% CI, 1.03-2.24). Concomitant use of gastroprotective agents was associated with a reduced risk of GIB (IRR, 0.52; 95% CI, 0.35-0.77). Subcategory analysis showed that use of proton pump inhibitors (IRR, 0.53; 95% CI, 0.31-0.91) or histamine type-2-receptor antagonists (IRR, 0.61; 95% CI, 0.40-0.94) were associated with a lower risk of GIB. Further analysis showed that the risk reduction by gastroprotective agents was significant for only upper GIB (IRR, 0.29; 95% CI, 0.15-0.54), and only for patients with a prior history of peptic ulcers or GIB (IRR, 0.14; 95% CI, 0.06-0.30). CONCLUSIONS: In the Hong Kong population, use of gastroprotective agents was associated with a reduced risk of GIB in patients taking dabigatran. The association was stronger for upper GIB than lower GIB, and in patients with a prior history of peptic ulcers or GIB.

Clinical and prognostic implications of existing and new-onset atrial fibrillation in patients undergoing transcatheter aortic valve implantation.

Atrial fibrillation (AF) is a common co-morbidity among patients undergoing Transcatheter Aortic Valve Implantation (TAVI). Only recently have the clinical outcomes of patients with chronic or new-onset AF after TAVI been reported. The absence of clinical trials focusing on this cohort of patients has resulted in the lack of evidence based clinical guidelines. We aim to review and discuss the current literature on AF in TAVI, its clinical implications and future perspectives.

Transcatheter aortic valve implantation using the slow balloon inflation technique: making balloon-expandable valves partially repositionable.

In transcatheter aortic valve implantation procedures using balloon-expandable valves, the valve is deployed by rapid balloon inflation within a short period of rapid ventricular pacing. This system and deployment technique is generally considered to be nonrepositionable. We illustrate with two cases (transapical and transfemoral) the possibility to partially reposition the valve during its deployment if a slow balloon inflation technique were employed-a technique that may minimize the risk of valve mal-positioning and its attendant complications.

Transaortic transcatheter aortic valve implantation: potential issues associated with the use of the ASCENDRA transapical delivery system.

Transaortic transcatheter aortic valve implantation (TAo-TAVI) has been recently proposed as an alternative to transapical (TA) and transfemoral (TF) approach. We now discuss a technical issue associated with TAo-TAVI related to the use of a delivery system dedicated to the antegrade TA approach. The potential solutions to this issue as well as the potential advantages of the TAo approach are discussed.

Transcatheter aortic valve implantation for the treatment of surgical valve dysfunction ("valve-in-valve"): assessing the risk of coronary obstruction.

Acute coronary obstruction is one of the most feared complications associated with transcatheter aortic valve-in-valve implantation. Strategies for assessing the risk of coronary occlusion during these procedures as well as preventive measures are discussed.

Comparative efficacy and safety of statin and fibrate monotherapy: A systematic review and meta-analysis of head-to-head randomized controlled trials.

OBJECTIVE: To assess whether in adults with dyslipidemia, statins reduce cardiovascular events, mortality, and adverse effects when compared to fibrates. METHODS: Systematic review and meta-analysis of head-to-head randomized trials of statin and fibrate monotherapy. MEDLINE, EMBASE, Cochrane, WHO International Controlled Trials Registry Platform, and ClinicalTrials.gov were searched through October 30, 2019. Trials that had a follow-up of at least 28 days, and reported mortality or a cardiovascular outcome of interest were eligible for inclusion. Efficacy outcomes were cardiovascular mortality and major cardiovascular events. Safety outcomes included myalgia, serious adverse effects, elevated serum creatinine, and elevated serum alanine aminotransferase. Odds ratios (OR) and 95% confidence intervals (CI) were estimated using the Mantel-Haenszel fixed-effect model, and heterogeneity was assessed using the I2 statistic. RESULTS: We included 19 eligible trials that directly compared statin and fibrate monotherapy and reported mortality or a cardiovascular event. Studies had a limited duration of follow-up (range 10 weeks to 2 years). We did not find any evidence of a difference between statins and fibrates for cardiovascular mortality (OR 2.35, 95% CI 0.94-5.86, I2 = 0%; ten studies, n = 2657; low certainty), major cardiovascular events (OR 1.15, 95% CI 0.80-1.65, I2 = 13%; 19 studies, n = 7619; low certainty), and myalgia (OR 1.32, 95% CI 0.95-1.83, I2 = 0%; ten studies, n = 6090; low certainty). Statins had less serious adverse effects (OR 0.57, 95% CI 0.36-0.91, I2 = 0%; nine studies, n = 3749; moderate certainty), less elevations in serum creatinine (OR 0.17, 95% CI 0.08-0.36, I2 = 0%; six studies, n = 2553; high certainty), and more elevations in alanine aminotransferase (OR 1.43, 95% CI 1.03-1.99, I2 = 44%; seven studies, n = 5225; low certainty). CONCLUSIONS: The eligible randomized trials of statins versus fibrates were designed to assess short-term lipid outcomes, making it difficult to have certainty about the direct comparative effect on cardiovascular outcomes and mortality. With the exception of myalgia, use of a statin appeared to have a lower incidence of adverse effects compared to use of a fibrate.

Thromboembolic, bleeding, and mortality risks among patients with nonvalvular atrial fibrillation treated with dual antiplatelet therapy versus oral anticoagulants: A population-based study.

BACKGROUND: Dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel is used for stroke prevention in patients with atrial fibrillation (AF) who refuse to take use oral anticoagulants (OACs). However, clinical data comparing these treatments are limited. OBJECTIVE: The purpose of this study was to compare the clinical outcomes between DAPT and OAC in patients with AF. METHODS: A cohort study using a population-wide database of the Hong Kong Hospital Authority was performed. New patients with AF from 2010-2014 who were prescribed DAPT or OAC (warfarin or dabigatran) were followed until July 31, 2016. Outcomes were thromboembolism, bleeding, and death. Propensity score (PS) matching at a ratio of 1:2 was used to select DAPT users with characteristics similar to those of OAC users, analyzed using Poisson regression. RESULTS: Among 51,946 new patients with AF, 8520 users of OAC and DAPT were identified. The likelihood of receiving DAPT over OAC increased with older age and previous intracranial hemorrhage. Among DAPT users, the incidences of thromboembolism, death, and bleeding per 100 patient-years were 15.8, 17.6, and 5.1, respectively. Compared to DAPT users, PS-matched analysis indicated a lower incidence of thromboembolism and/or death among OAC users (dabigatran: incidence rate ratio [IRR] 0.32; 95% confidence interval [CI] 0.19-0.55; warfarin: IRR 0.58; 95% CI 0.36-0.95), with no significant differences in bleeding events. CONCLUSION: DAPT users were at markedly increased risk for thromboembolism and death compared to OAC users. These findings indicate the need for improved stroke risk reduction strategies among patients taking DAPT and the opportunities for using OAC in high-risk groups to prevent additional events.

Trends in statin prescription prevalence, initiation, and dosing: Hong Kong, 2004-2015.

BACKGROUND AND AIMS: Clinical practice guidelines recommend specific statin doses for the primary and secondary prevention of cardiovascular disease. Little is known about how statin utilization and dosing have evolved over time in Hong Kong. The aim of this study was to describe trends in statin prevalence, initiation, and dosing from 2004 to 2015. METHODS: Patients receiving public health services, who were prescribed a statin, were included if they received a lipid test at a single center (n = 58,672). Using the territory-wide electronic health record, prescribed daily statin dose, nondaily dose frequency, and statin dose intensity were determined for statin prescriptions from 2004 to 2015. Statin prescription prevalence and initiation rates were estimated using the appropriate at-risk population in the hospital catchment area as the denominator. Prescribed daily doses were stratified by primary or secondary cardiovascular prevention status to assess changes in statin dosing over time. RESULTS: The prescription prevalence of statins was higher in 2015 (8.68%; 95% CI, 8.60%-8.75%) as compared with 2004 (1.82%; 95% confidence interval [CI], 1.78%-1.86%). Initiation rates for new statin users increased from 2004 to 2013. High-intensity statins were infrequently prescribed. New users generally had higher statin initiation rates for primary prevention. There were small increases in the prescribed daily doses of statins. Nondaily statin dosing was infrequent (0.42% of all prescriptions). CONCLUSIONS: The prevalence and initiation of statin prescriptions increased in Hong Kong, and was in part driven by low-intensity statins for the primary prevention of cardiovascular disease.

His-Bundle Pacing in a Patient with Transcatheter Aortic Valve Implantation-Induced Left Bundle Branch Block.

Transcatheter aortic valve implantation (TAVI) is an effective intervention for severe aortic stenosis in patients at intermediate or high surgical risk, but damage to the native conduction system such as left bundle branch block (LBBB) may offset its benefits. New onset LBBB is associated with a higher risk of cardiovascular morbidity and mortality. His-bundle pacing (HBP) may be useful to treat TAVI-induced LBBB but has yet to be reported. We present the case of a 76-year-old man with severe symptomatic aortic stenosis treated with TAVI. His preoperative electrocardiogram showed sinus rhythm with a narrow QRS complex. Insertion of a CoreValve Evolut R transcatheter aortic valve was uneventful apart from the development of LBBB with a long PR interval. A dual-lead DDD pacemaker was implanted via the left cephalic vein on the following day. HV was mildly prolonged at 60 ms. Capture of the proximal His restored AV synchrony without correction of LBBB. Repositioning of the lead with capture of the left bundle branch enabled complete ventricular resynchronisation with a single lead. Our case demonstrates that LBBB in the setting of TAVI may be corrected by HBP.

Sex-Based Differences in Outcomes of Oral Anticoagulation in Patients With Atrial Fibrillation.

BACKGROUND: Women with atrial fibrillation are at a higher risk of stroke, despite treatment with warfarin. It is unclear if women treated with direct oral anticoagulants (DOACs) have better clinical outcomes, especially when considering the quality of anticoagulation control of warfarin. OBJECTIVES: This study compared the effectiveness and safety outcomes of DOACs versus warfarin in men and women with stratifications for anticoagulation control. METHODS: Patients newly diagnosed with atrial fibrillation and prescribed oral anticoagulants during 2010 to 2015 were identified using the Hong Kong clinical database. Propensity score matching was performed in men and women separately. Further analysis was conducted to stratify warfarin users according to their anticoagulation control. Cox regression was used to compare the risk of ischemic stroke or systemic embolism, intracranial hemorrhage (ICH), gastrointestinal bleeding, and all-cause mortality in the specific sex. RESULTS: There were 4,972 men and 4,834 women successfully matched in our cohort. Compared with warfarin, DOAC use was associated with a lower risk of ICH (hazard ratio [HR]: 0.16; 95% confidence interval [CI]: 0.06 to 0.40) and all-cause mortality (HR: 0.55; 95% CI: 0.39 to 0.77) in women but not in men. The treatment by sex interaction was significant for ICH only, and a significantly lower risk of ICH remained in the DOAC group when compared with warfarin users with good anticoagulation control (HR: 0.13; 95% CI: 0.02 to 1.00) among women only. The risks of ischemic stroke or systemic embolism and gastrointestinal bleeding with DOACs versus warfarin were comparable in both sexes. CONCLUSIONS: DOACs were associated with a lower risk of ICH and all-cause mortality in women only, where the association of lower ICH risk remained when compared with warfarin users with good anticoagulation control.

Prognostic Value of Fat Mass and Skeletal Muscle Mass Determined by Computed Tomography in Patients Who Underwent Transcatheter Aortic Valve Implantation.

Body composition (fat mass [FM] and skeletal muscle mass [SMM]) predicts clinical outcomes. In particular, loss of SMM (sarcopenia) is associated with frailty and mortality. There are no data on the prevalence and impact of FM and SMM in patients undergoing transcatheter aortic valve implantation (TAVI). The objective of this study is to determine body composition from pre-TAVI computed tomography (CT) and evaluate its association with clinical outcomes in patients who underwent TAVI. A total of 460 patients (mean age 81 ± 8 years, men: 51%) were included. Pre-TAVI CTs of the aorto-ilio-femoral axis were analyzed for FM and SMM cross-sectional area at the level of the third lumbar vertebrae (L3). Regression equations correlating cross-sectional area at L3 to total body FM and SMM were used to determine prevalence of sarcopenia, obesity, and sarcopenic obesity in patients (64%, 65%, and 46%, respectively). Most TAVI procedures were performed through a transfemoral approach (59%) using a balloon-expandable valve (94%). The 30-day and mid-term (median 12 months [interquartile range 6 to 27]) mortality rates were 6.1% and 29.6%, respectively. FM had no association with clinical outcomes, but sarcopenia predicted cumulative mortality (hazard ratio 1.55, 95% confidence interval 1.02 to 2.36, p = 0.04). In conclusion, body composition analysis from pre-TAVI CT is feasible. Sarcopenia, obesity, and sarcopenic obesity are prevalent in the TAVI population, with sarcopenia predictive of cumulative mortality.

Conditionally replicative adenovirus driven by the human telomerase promoter provides broad-spectrum antitumor activity without liver toxicity.

The human telomerase reverse transcriptase (hTERT) promoter is known to selectively drive transgene expression in many human cancer cells expressing hTERT, the catalytic component of the telomerase ribonucleoprotein complex. We have created a conditionally replicative adenovirus where the viral E1A gene, which is required for viral replication, is under the control of the hTERT promoter (AdhTERTp-E1A). In vitro studies with AdhTERTp-E1A virus on a variety of normal and tumor cell lines have shown that viral genome replication and productive infection is primarily restricted to telomerase-positive tumor cells. Lytic replication was not observed in normal primary fibroblast and epithelial cell lines tested. In vivo administration of the virus into nude mice bearing human liver or prostate tumor xenografts produced significant tumor reduction and, in some cases, resulted in complete tumor regression. AdhTERTp-E1A virus did not actively express E1A in normal mouse liver, in contrast to a control oncolytic vector in which the CMV promoter (AdCMVp-E1A) was driving the E1A gene. In addition, AdhTERTp-E1A virus produced no apparent toxicity to the liver in systemically injected mice. The hTERT promoter-driven oncolytic virus also produced significantly less toxicity to freshly cultured human hepatocytes. These studies demonstrate that an oncolytic virus driven by the telomerase promoter can be used to effectively kill a wide variety of cancer cell types and has the potential to treat primary and metastatic cancer of diverse origins.

Photosymbiotic ascidians in Singapore: turbid waters may reduce living space.

The photosymbiotic ascidian fauna at Changi Beach, Pulau Semakau, Sentosa and St. John's Island, Singapore were surveyed. A total of five species, Diplosoma simile, Lissoclinum bistratum, Lissoclinum punctatum, Lissoclinum timorense and Trididemnum cyclops, were recorded, with Lissoclinum timorense and Trididemnum cyclops being newly recorded in Singapore. However, no photosymbiotic species were found at Changi Beach probably due to the polluted waters in the region. Coastal development has caused Singapore waters to become turbid, leading to decrease in suitable habitats for photosymbiotic ascidians. Clean waters in Pulau Semakau probably provide a better environment for the growth of photosymbiotic ascidians and this area has a greater variety of these ascidians than the other areas in Singapore. Each of the five species has also been recorded in the Ryukyu Archipelago (Japan) and three species (Diplosoma simile, Lissoclinum bistratum and Trididemnum cyclops) have also been recorded in Taiwan.

Transcatheter aortic valve replacement with the SAPIEN 3: a new balloon-expandable transcatheter heart valve.

OBJECTIVES: The aim of this study was to demonstrate the first-in-human feasibility and short-term clinical outcomes with a new balloon-expandable transcatheter heart valve (THV). BACKGROUND: The SAPIEN 3 (S3) THV incorporates a paravalvular sealing system, an active 3-dimensional coaxial positioning catheter, and is compatible with a 14-F expandable sheath. METHODS: The S3 THV was implanted in 15 patients with symptomatic severe aortic stenosis via femoral arterial access. Multidetector computed tomography before and after valve implantation allowed assessment of a novel annular area sizing algorithm. Clinical and echocardiographic data were obtained at baseline, discharge, and 30 days. RESULTS: All 15 device implants were successful. Multidetector computed tomography estimated an aortic annular area of 4.9 ± 0.4 cm(2), predicting 9.7 ± 6.9% THV oversizing. Post-transcatheter aortic valve replacement multidetector computed tomography showed consistently symmetrical and circular THVs. Aortic valve area increased from 0.7 ± 0.2 cm(2) to 1.5 ± 0.2 cm(2) (p < 0.001), and mean transaortic gradient decreased from 42.2 ± 10.3 mm Hg to 11.9 ± 5.3 mm Hg (p < 0.001). No patient had more than mild paravalvular aortic regurgitation. Hospital discharge occurred at a median of 3 (range 2 to 12) hospital days. At 30 days there were no deaths, strokes, vascular complications, bleeds, or transfusions, although 1 patient (6.7%) required a new pacemaker. All patients were in New York Heart Association functional class I or II. CONCLUSIONS: The S3 THV and delivery system might facilitate fully percutaneous implantation in a broader range of patients with the potential for more accurate positioning and less paravalvular regurgitation.

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.

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.

Comparison of hemodynamic performance of self-expandable CoreValve versus balloon-expandable Edwards SAPIEN aortic valves inserted by catheter for aortic stenosis.

Transcatheter aortic valve implantation with the self-expandable CoreValve (CV) and the balloon-expandable Edwards SAPIEN (ES) bioprostheses has been widely used for the treatment of severe aortic stenosis. However, a direct comparison of the hemodynamic results associated with these 2 prostheses is lacking. The aim of the present study was to compare the hemodynamic performance of both bioprostheses. A total of 41 patients who underwent transcatheter aortic valve implantation with the CV prosthesis were matched 1:1 for prosthesis size (26 mm), aortic annulus size, left ventricular ejection fraction, body surface area, and body mass index with patients who underwent transcatheter aortic valve implantation with the ES prosthesis. Doppler-echocardiographic data were prospectively collected before the intervention and at hospital discharge, and all examinations were sent to, and analyzed in, a central echocardiography core laboratory. The mean transprosthetic residual gradient was lower (p = 0.024) in the CV group (7.9 ± 3.1 mm Hg) than in the ES group (9.7 ± 3.8 mm Hg). The effective orifice area tended to be greater in the CV group (1.58 ± 0.31 cm(2) vs 1.49 ± 0.24 cm(2), p = 0.10). The incidence of severe prosthesis-patient mismatch was, however, similar between the 2 groups (effective orifice area indexed to the body surface area ≤0.65 cm(2)/m(2); CV 9.8%, ES 9.8%, p = 1.0). The incidence of paravalvular aortic regurgitation was greater with the CV (grade 1 or more in 85.4%, grade 2 or more in 39%) than with the ES (grade 1 or more in 58.5%, grade 2 or more in 22%; p = 0.001). The number and extent of paravalvular leaks were greater in the CV group (p <0.01 for both comparisons). In conclusion, transcatheter aortic valve implantation with the CV prosthesis was associated with a lower residual gradient but a greater rate of paravalvular aortic regurgitation compared to the ES prosthesis. The potential clinical consequences of the differences in hemodynamic performance between these transcatheter heart valves needs to be addressed in future studies.