23 results on '"Cohen, Mauricio G."'
Search Results
2. Transcatheter Aortic Valve Replacement for Severe Symptomatic Aortic Stenosis in Rheumatic Heart Disease: A Systematic Review.
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Fernandes ADF, Fernandes GC, Grant J, Knijnik L, Cardoso R, Cohen MG, Ferreira AC, and Alfonso CE
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- Aged, Aortic Valve surgery, Female, Humans, Male, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Rheumatic Heart Disease complications, Rheumatic Heart Disease surgery, Transcatheter Aortic Valve Replacement methods
- Abstract
Transcatheter aortic valve replacement (TAVR) is well-established for severe symptomatic aortic stenosis (AS), but its use in rheumatic heart disease (RHD) has been limited. We systematically review the use of TAVR for severe symptomatic AS in RHD. Pubmed, Embase, and Scopus were searched for TAVR for symptomatic severe AS and proven or suspected RHD. Procedure characteristics, efficacy, and safety endpoints were collected and all definitions were based on the Valve Academic Research Consortium-2 (VARC-2) criteria. We included 3 case series and 12 case reports, with a total of 43 patients. Mean age was 76 years, 75% were female, and 85% had NYHA class III-IV symptoms. Follow up ranged from 1 to 29 months. Patients were moderate to high risk, with Society of Thoracic Surgery score ranging from 6.1% to 17.6%. The approach was transfemoral in 30 (83%) cases. Procedural success occurred in 37 (86%) patients. Of the 7 patients with periprocedural complications, 4 had valve dislodgement, 1 deployment failure, 1 unplanned cardiopulmonary bypass, and 1 moderate aortic regurgitation. Paravalvular leak was reported in 5 (11.6%) patients. Only 1 patient had heart block requiring pacemaker. Among 13 studies (23 patients), 30-day mortality was 0%. One case series with 19 patients had a 30-day, 1-year, 2-year, and 5-year mortality of 5%, 11%, 31%, and 48%, respectively. TAVR appears feasible for selected patients with rheumatic severe AS, albeit our results indicate a 14% incidence of device failure. Future randomized clinical trials may clarify the role of TAVR in this group., Competing Interests: Disclosure: The authors declare no funding and conflict of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2022
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3. The Influence of Frailty on Cardiovascular Disease: The Time for a "Frailty Academic Research Consortium" Is Now!
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Damluji AA and Cohen MG
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- Humans, Treatment Outcome, Aortic Valve Stenosis surgery, Cardiovascular Diseases diagnosis, Frailty diagnosis, Transcatheter Aortic Valve Replacement
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- 2022
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4. Transfusion and Mortality After Transcatheter Aortic Valve Replacement: Association or Causation?
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Costa F and Cohen MG
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- Aortic Valve diagnostic imaging, Aortic Valve surgery, Blood Transfusion, Humans, Registries, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Transcatheter Aortic Valve Replacement adverse effects
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- 2020
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5. Transcatheter Aortic Valve Replacement in Low-Population Density Areas: Assessing Healthcare Access for Older Adults With Severe Aortic Stenosis.
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Damluji AA, Fabbro M 2nd, Epstein RH, Rayer S, Wang Y, Moscucci M, Cohen MG, Carroll JD, Messenger JC, Resar JR, Cohen DJ, Sherwood MW, O'Connor CM, and Batchelor W
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- Age Factors, Aged, Aged, 80 and over, Aortic Valve Stenosis mortality, Catchment Area, Health, Databases, Factual, Female, Florida, Hospital Mortality trends, Humans, Male, Population Density, Residence Characteristics, Retrospective Studies, Severity of Illness Index, Time Factors, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement mortality, Travel trends, Treatment Outcome, Aortic Valve Stenosis surgery, Health Services Accessibility trends, Healthcare Disparities trends, Rural Health Services trends, Transcatheter Aortic Valve Replacement trends
- Abstract
Background: Restricting transcatheter aortic valve replacement (TAVR) to centers based on volume thresholds alone can potentially create unintended disparities in healthcare access. We aimed to compare the influence of population density in state of Florida in regard to access to TAVR, TAVR utilization rates, and in-hospital mortality., Methods and Results: From 2011 to 2016, we used data from the Agency for Health Care Administration to calculate travel time and distance for each TAVR patient by comparing their home address to their TAVR facility ZIP code. Travel time and distance, TAVR rates, and mortality were compared across categories of low to high population density (population per square miles of land). Of the 6531 patients included, the mean (SD) age was 82 (9) years, 43% were female and 91% were White. Patients residing in the lowest category (<50/square miles) were younger, more likely to be men, and less likely to be a racial minority. Those residing in the lowest category density faced a longer unadjusted driving distances and times to their TAVR center (mean extra distance [miles]=43.5 [95% CI, 35.6-51.4]; P <0.001; mean extra time (minutes)=45.6 [95% CI, 38.3-52.9], P <0.001). This association persisted regardless of the methods used to determine population density. Excluding uninhabitable land, there was a 7-fold difference in TAVR utilization rates in the lowest versus highest population density regions (7 versus 45 per 100 000, P -for-pairwise-comparisons <0.001) and increase in TAVR in-hospital mortality (adjusted OR, 6.13 [95% CI, 1.97-19.1]; P <0.001)., Conclusions: Older patients living in rural counties in Florida face (1) significantly longer travel distances and times for TAVR, (2) lower TAVR utilization rates, and (3) higher adjusted TAVR mortality. These findings suggest that there are trade-offs between access to TAVR, its rate of utilization, and procedural mortality, all of which are important considerations when defining institutional and operator requirements for TAVR across the country.
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- 2020
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6. Cardiac conduction abnormalities associated with pacemaker implantation after transcatheter aortic valve replacement.
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Cresse S, Eisenberg T, Alfonso C, Cohen MG, DeMarchena E, Williams D, and Carrillo R
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- Aged, 80 and over, Disease Progression, Electrocardiography, Female, Heart Conduction System physiopathology, Humans, Male, Retrospective Studies, Heart Block etiology, Heart Block therapy, Pacemaker, Artificial, Postoperative Complications etiology, Postoperative Complications therapy, Transcatheter Aortic Valve Replacement
- Abstract
Background: Complete heart block is a known complication after transcatheter aortic valve replacement (TAVR), often requiring pacemaker implantation within 24 hours of the procedure. However, clinical markers for delayed progression to complete heart block after TAVR remain unclear., Objectives: We examined electrocardiographic data that may correlate with delayed progression to complete heart block and need for pacemaker., Methods: This is a single-center retrospective study of 608 patients who underwent TAVR between April 2008 and June 2017. We excluded 164 (27.0%) patients due to having a pacemaker before the procedure or expiring within 24 hours of the procedure (8, 1.3%). We excluded an additional 50 (8.2%) patients who received a pacemaker within 24 hours of the procedure. Electrocardiograms (EKGs) obtained after the procedure were compared to the preprocedural EKG to detect new changes., Results: Left bundle branch block, intraventricular conduction delay, left anterior fascicular block, and right bundle branch block were the most commonly seen conduction abnormalities after TAVR (25.1%, 10.9%, 7.5%, and 3.6%, respectively). Both left bundle branch block (odds ratio [OR] = 2.77 [95% confidence interval (CI): 1.24-6.22]) and right bundle branch block (OR = 13.2 [95% CI: 4.18-41.70]) carried an increased risk of pacemaker implantation after TAVR. Additionally, ΔPR greater than 40 ms from baseline also carried an increased risk of pacemaker implantation (OR = 3.53 [95% CI: 1.49-8.37])., Conclusion: Left bundle branch block, right bundle branch block, and ΔPR greater than 40 ms were all associated with delayed progression to complete heart block and need for pacemaker implantation after TAVR., (© 2019 Wiley Periodicals, Inc.)
- Published
- 2019
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7. Alternative access for transcatheter aortic valve replacement in older adults: A collaborative study from France and United States.
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Damluji AA, Murman M, Byun S, Moscucci M, Resar JR, Hasan RK, Alfonso CE, Carrillo RG, Williams DB, Kwon CC, Cho PW, Dijos M, Peltan J, Heldman AW, Cohen MG, and Leroux L
- Subjects
- Aged, Aged, 80 and over, Aortic Valve diagnostic imaging, Aortic Valve physiopathology, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis mortality, Aortic Valve Stenosis physiopathology, Catheterization, Peripheral adverse effects, Catheterization, Peripheral mortality, Databases, Factual, Female, France, Hospital Mortality, Humans, Male, Postoperative Complications mortality, Postoperative Complications surgery, Reoperation, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, United States, Aortic Valve surgery, Aortic Valve Stenosis surgery, Catheterization, Peripheral methods, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement instrumentation, Transcatheter Aortic Valve Replacement mortality
- Abstract
Background: We examined the outcomes of older adults undergoing nontrans-femoral (non-TF) transcatheter aortic valve replacement (TAVR) procedures including trans-apical (TA), trans-aortic (TAo), trans-subclavian (TSub), and trans-carotid (TCa) techniques., Methods and Results: This is an observational study of all consecutive older patients who underwent non-TF TAVR for symptomatic severe AS with Edwards Sapien (ES), Medtronic CoreValve, ES3 or Lotus Valve at three centers in France and the United States from 04/2008 to 02/2017. Baseline characteristics and clinical outcomes were defined according to VARC-2 criteria. Of 857 patients who received TAVR, 172 (20%) had an alternative access procedure. Of these, 45 (26%) were TA, 67 (39%) TAo, 17 (10%) TSub, and 43 (25%) TCa procedures. The preference for non-TF access site was different between the two countries (US: TA 39%, TAo 52%, TSub 9%; TCa 0% vs. France: TA 9%, TAo 23%, TSub 11%, and TCa 57%, P-value < .001). Most patients who underwent TAo TAVR were older women (median age: TA 82, TAo 84, TSub 81, TCa 81, P-value = 0.043; female gender: TA 32 (27%), TAo 30 (55%), TSub 10 (41%), TCa 27 (37%), P-value = .021). The predicted Society of Thoracic Surgery risk of mortality was similar among groups (TA 7%, TAo 7%, TSub 6%, TCa 7%, P-value= .738). No differences were observed in the frequency of para-valvular leak, intra-procedural bleeding, vascular complications, conversion to open-heart surgery, or development of acute kidney injury. The highest in-hospital mortality was observed in the TAo group (TA 2%, TAo 15%, TSub 0%, TCa 2%, P-value = .014). However, hospital length of stay, one-month, and one-year mortality were similar among non-TF techniques., Conclusion: Although regional differences exist in the choice of alternative access techniques, centers with high technical expertise can provide a safe alternative to traditional TF TAVR. TAo TAVR was associated with higher in-hospital mortality than other non-TF approaches, and this may have reflected patient rather than procedural factors. All alternative access techniques had similar mortality rates and clinical outcomes at one-year follow-up. Trans-carotid access is safe and feasible compared to other non-TF access techniques., (© 2018 Wiley Periodicals, Inc.)
- Published
- 2018
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8. Coil embolization to successfully treat annular rupture during transcatheter aortic valve replacement.
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Azarrafiy R, Albuquerque FN, Carrillo RG, and Cohen MG
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- Aged, 80 and over, Aortic Valve Stenosis diagnostic imaging, Cardiac Tamponade diagnostic imaging, Cardiac Tamponade etiology, Heart Injuries diagnostic imaging, Heart Injuries etiology, Humans, Male, Treatment Outcome, Aortic Valve Stenosis surgery, Cardiac Tamponade therapy, Embolization, Therapeutic instrumentation, Heart Injuries therapy, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Aortic annular rupture is one of the most feared complications of transcatheter aortic valve replacement (TAVR). This complication often presents as sudden cardiac tamponade with hypotension and requires urgent intervention. The traditional rescue strategy for such cases is emergency surgical intervention, yet the mortality remains high considering most patients who undergo TAVR are not candidates for open heart surgery. As such, there is a need for percutaneous alternatives to treat this critical complication. Here, we describe a case of annular rupture during TAVR that was successfully treated with coil embolization at the rupture site. This case illustrates the use of coil embolization as a treatment strategy in patients with acute aortic annular rupture who are at high-risk for surgical intervention., (© 2018 Wiley Periodicals, Inc.)
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- 2018
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9. Transcatheter Aortic Valve Replacement.
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Iluyomade A and Cohen MG
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- Aortic Valve surgery, Humans, Length of Stay, Patient Discharge, United States, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement
- Published
- 2018
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10. Incidence, predictors and clinical outcomes of residual stenosis after aortic valve-in-valve.
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Bleiziffer S, Erlebach M, Simonato M, Pibarot P, Webb J, Capek L, Windecker S, George I, Sinning JM, Horlick E, Napodano M, Holzhey DM, Petursson P, Cerillo A, Bonaros N, Ferrari E, Cohen MG, Baquero G, Jones TL, Kalra A, Reardon MJ, Chhatriwalla A, Gama Ribeiro V, Alnasser S, Van Mieghem NM, Rustenbach CJ, Schofer J, Garcia S, Zeus T, Champagnac D, Bekeredjian R, Kornowski R, Lange R, and Dvir D
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- Aged, Aged, 80 and over, Body Mass Index, Echocardiography methods, Female, Humans, Incidence, Male, Outcome Assessment, Health Care, Predictive Value of Tests, Prosthesis Design, Prosthesis Failure, Risk Assessment, Risk Factors, Aortic Valve diagnostic imaging, Aortic Valve physiopathology, Aortic Valve Stenosis physiopathology, Aortic Valve Stenosis surgery, Bioprosthesis adverse effects, Heart Valve Prosthesis adverse effects, Hemodynamics, Postoperative Complications diagnosis, Postoperative Complications etiology, Postoperative Complications physiopathology, Postoperative Complications surgery, Reoperation instrumentation, Reoperation methods, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement methods
- Abstract
Objective: We aimed to analyse the incidence of prosthesis-patient mismatch (PPM) and elevated gradients after aortic valve in valve (ViV), and to evaluate predictors and associations with clinical outcomes of this adverse event., Methods: A total of 910 aortic ViV patients were investigated. Elevated residual gradients were defined as ≥20 mm Hg. PPM was identified based on the indexed effective orifice area (EOA), measured by echocardiography, and patient body mass index (BMI). Moderate and severe PPM (cases) were defined by European Association of Cardiovascular Imaging (EACVI) criteria and compared with patients without PPM (controls)., Results: Moderate or greater PPM was found in 61% of the patients, and severe in 24.6%. Elevated residual gradients were found in 27.9%. Independent risk factors for the occurrence of lower indexed EOA and therefore severe PPM were higher gradients of the failed bioprosthesis at baseline (unstandardised beta -0.023; 95% CI -0.032 to -0.014; P<0.001), a stented (vs a stentless) surgical bioprosthesis (unstandardised beta -0.11; 95% CI -0.161 to -0.071; P<0.001), higher BMI (unstandardised beta -0.01; 95% CI -0.013 to -0.007; P<0.001) and implantation of a SAPIEN/SAPIEN XT/SAPIEN 3 transcatheter device (unstandardised beta -0.064; 95% CI -0.095 to -0.032; P<0.001). Neither severe PPM nor elevated gradients had an association with VARC II-defined outcomes or 1-year survival (90.9% severe vs 91.5% moderate vs 89.3% none, P=0.44)., Conclusions: Severe PPM and elevated gradients after aortic ViV are very common but were not associated with short-term survival and clinical outcomes. The long-term effect of poor post-ViV haemodynamics on clinical outcomes requires further evaluation., Competing Interests: Competing interests: DD is a consultant for Edwards Lifesciences, Medtronic and Abbott. SB is a proctor and consultant for Medtronic and a proctor for Boston Scientific and JenaValve. RL is a member of the Medtronic advisory board. SG is a consultant for Edwards Lifesciences, Medtronic, Surmodics, Osprey Medical and Boston Scientific and also repots research grants from Edwards Lifesciences and VA Office of Research and Development. EF reports consulting and proctoring for Edwards Lifesciences. DH is a member of the Medtronic advisory board. TZ reports lecture fees from Edwards Lifesciences and Medtronic. MJR is a consultant for Medtronic, Abbott and Boston Scientific. SW reports institutional research grants from Amgen, Abbott, Boston Scientific, Biotronik and St. Jude Medical. NMvM reports research grant support from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, Claret and Essential Medical. NB has received research grants from Edwards Lifesciences and speaker honoraria from Edwards Lifesciences, Medtronic and Abbott. AC is part of the speakers bureau for Edwards Lifesciences, Medtronic and Abbott, and also reports proctoring for Medtronic. J-MS reports research grants and speaker honoraria from Medtronic, Edwards Lifesciences, Boston Scientific, and Abbott. No other conflicts of interest were reported., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)
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- 2018
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11. Incidence, predictors, and clinical outcomes of coronary obstruction following transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: insights from the VIVID registry.
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Ribeiro HB, Rodés-Cabau J, Blanke P, Leipsic J, Kwan Park J, Bapat V, Makkar R, Simonato M, Barbanti M, Schofer J, Bleiziffer S, Latib A, Hildick-Smith D, Presbitero P, Windecker S, Napodano M, Cerillo AG, Abdel-Wahab M, Tchetche D, Fiorina C, Sinning JM, Cohen MG, Guerrero ME, Whisenant B, Nietlispach F, Palma JH, Nombela-Franco L, de Weger A, Kass M, Sandoli de Brito F Jr, Lemos PA, Kornowski R, Webb J, and Dvir D
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- Aged, Coronary Occlusion diagnostic imaging, Coronary Occlusion etiology, Female, Heart Valve Prosthesis, Humans, Incidence, Male, Multivariate Analysis, Registries, Risk Factors, Coronary Occlusion epidemiology, Multidetector Computed Tomography methods, Prosthesis Failure adverse effects, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Aims: There are limited data on coronary obstruction following transcatheter valve-in-valve (ViV) implantation inside failed aortic bioprostheses. The objectives of this study were to determine the incidence, predictors, and clinical outcomes of coronary obstruction in transcatheter ViV procedures., Methods and Results: A total of 1612 aortic procedures from the Valve-in-Valve International Data (VIVID) Registry were evaluated. Data were subject to centralized blinded corelab computed tomography (CT) analysis in a subset of patients. The virtual transcatheter valve to coronary ostium distance (VTC) was determined. A total of 37 patients (2.3%) had clinically evident coronary obstruction. Baseline clinical characteristics in the coronary obstruction patients were similar to controls. Coronary obstruction was more common in stented bioprostheses with externally mounted leaflets or stentless bioprostheses than in stented with internally mounted leaflets bioprostheses (6.1% vs. 3.7% vs. 0.8%, respectively; P < 0.001). CT measurements were obtained in 20 (54%) and 90 (5.4%) of patients with and without coronary obstruction, respectively. VTC distance was shorter in coronary obstruction patients in relation to controls (3.24 ± 2.22 vs. 6.30 ± 2.34, respectively; P < 0.001). Using multivariable analysis, the use of a stentless or stented bioprosthesis with externally mounted leaflets [odds ratio (OR): 7.67; 95% confidence interval (CI): 3.14-18.7; P < 0.001] associated with coronary obstruction for the global population. In a second model with CT data, a shorter VTC distance predicted this complication (OR: 0.22 per 1 mm increase; 95% CI: 0.09-0.51; P < 0.001), with an optimal cut-off level of 4 mm (area under the curve: 0.943; P < 0.001). Coronary obstruction was associated with a high 30-day mortality (52.9% vs. 3.9% in the controls, respectively; P < 0.001)., Conclusion: Coronary obstruction following aortic ViV procedures is a life-threatening complication that occurred more frequently in patients with prior stentless or stented bioprostheses with externally mounted leaflets and in those with a short VTC., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2018
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12. Procedural Techniques for the Management of Severe Transvalvular and Paravalvular Aortic Regurgitation During TAVR.
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Damluji AA, Alfonso CE, and Cohen MG
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- Aortic Valve, Humans, Prosthesis Design, Risk Factors, Severity of Illness Index, Treatment Outcome, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Valve Prosthesis Implantation, Transcatheter Aortic Valve Replacement
- Abstract
Aortic regurgitation (AR) after transcatheter aortic valve replacement (TAVR) is associated with an increased risk of mortality. In severe cases, abrupt hemodynamic changes may occur with a sudden increase in left ventricular end-diastolic pressure that results in frank pulmonary edema, hypoxia, and cardiogenic shock. Here, the case is reported of a patient who developed severe AR immediately after valve deployment that led to severe hemodynamic compromise. The procedural techniques necessary for the immediate management of severe transvalvular and paravalvular AR are described.
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- 2017
13. Comparison of Outcomes of Transcatheter Aortic Valve Replacement Plus Percutaneous Coronary Intervention Versus Transcatheter Aortic Valve Replacement Alone in the United States.
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Singh V, Rodriguez AP, Thakkar B, Patel NJ, Ghatak A, Badheka AO, Alfonso CE, de Marchena E, Sakhuja R, Inglessis-Azuaje I, Palacios I, Cohen MG, Elmariah S, and O'Neill WW
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- Aged, Aged, 80 and over, Aortic Valve surgery, Aortic Valve Stenosis complications, Cardiac Catheterization methods, Coronary Artery Disease complications, Female, Follow-Up Studies, Hospital Mortality trends, Humans, Length of Stay trends, Male, Middle Aged, Propensity Score, Retrospective Studies, Risk Factors, Time Factors, United States epidemiology, Aortic Valve Stenosis surgery, Coronary Artery Disease surgery, Drug-Eluting Stents, Percutaneous Coronary Intervention methods, Transcatheter Aortic Valve Replacement methods
- Abstract
Transcatheter aortic valve replacement (TAVR) with percutaneous coronary intervention (PCI) has emerged as a less-invasive therapeutic option for high surgical risk patients with aortic stenosis and coronary artery disease. The aim of this study was to determine the outcomes of TAVR when performed with PCI during the same hospitalization. We identified patients using the International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes from the Nationwide Inpatient Sample between the years 2011 and 2013. A total of 22,344 TAVRs were performed between 2011 and 2013. Of these, 21,736 (97.3%) were performed without PCI (TAVR group) while 608 (2.7%) along with PCI (TAVR + PCI group). Among the TAVR + PCI group, 69.7% of the patients had single-vessel, 22.2% had 2-vessel, and 1.6% had 3-vessel PCI. Drug-eluting stents were more commonly used than bare-metal stents (72% vs 28%). TAVR + PCI group witnessed significantly higher rates of mortality (10.7% vs 4.6%) and complications: vascular injury requiring surgery (8.2% vs 4.2%), cardiac (25.4% vs 18.6%), respiratory (24.6% vs 16.1%), and infectious (10.7% vs 3.3%), p <0.001% for all, compared with the TAVR group. The mean length of hospital stay and cost of hospitalization were also significantly higher in the TAVR + PCI group. The propensity score-matched analysis yielded similar results. In conclusion, performing PCI along with TAVR during the same hospital admission is associated with higher mortality, complications, and cost compared with TAVR alone. Patients would perhaps be better served by staged PCI before TAVR., (Copyright © 2016. Published by Elsevier Inc.)
- Published
- 2016
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14. Transient and persistent conduction abnormalities following transcatheter aortic valve replacement with the Edwards-Sapien prosthesis: a comparison between antegrade vs. retrograde approaches.
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Sager SJ, Damluji AA, Cohen JA, Shah S, O'Neill BP, Alfonso CE, Martinez CA, Myerburg RJ, Heldman AW, Cohen MG, Williams DB, and Carrillo RG
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- Acute Disease, Aged, 80 and over, Arrhythmias, Cardiac diagnosis, Chronic Disease, Equipment Design, Equipment Failure Analysis, Female, Florida epidemiology, Humans, Incidence, Male, Postoperative Complications diagnosis, Postoperative Complications prevention & control, Prosthesis Design, Risk Factors, Survival Rate, Aortic Valve surgery, Arrhythmias, Cardiac mortality, Heart Valve Prosthesis statistics & numerical data, Postoperative Complications mortality, Transcatheter Aortic Valve Replacement mortality
- Abstract
Background: Electrocardiographic conduction abnormalities following transcatheter aortic valve replacement (TAVR) with the Edwards-Sapien valve (ESV) are not uncommon and may be transient. We sought to examine the clinical time-course of conduction abnormalities after TAVR with ESV and determine risk factors for persistent abnormalities., Methods: In this single-center prospective study, 116 consecutive patients underwent implantation of the ESV after approval by the Food and Drug Administration (FDA). Demographic, clinical, and intra-procedural variables were collected in a registry, including ECGs before, immediately after, and at discharge from hospital. Conduction abnormalities were analyzed including PR interval lengthening, QRS widening, left bundle branch block (LBBB), and high-grade AV block., Results: There were 92 patients included in the analysis. A total of 41 new conduction abnormalities were observed in 31 (34 %) patients: 7 new PR prolongation, 14 QRS widening, 14 new LBBB, and 5 high-grade AV block requiring permanent pacemaker. Of the 41 new CAs, 11 (27 %) were transient; of the transient abnormalities, 9 (82 %) resolved within 24 h of the index procedure. Chronic kidney disease was a risk factor for the development of a persistent abnormality and for need for PPM. Antegrade approach was associated with the development of persistent LBBB and persistent QRS widening., Conclusions: A significant proportion of conduction abnormalities after ESV implantation improved prior to discharge from the hospital, usually within 24 h. CKD is associated with persistence of abnormalities and with need for PPM. Antegrade approach increases risk for new intraventricular conduction delays, including LBBB.
- Published
- 2016
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15. Elective or Emergency Use of Mechanical Circulatory Support Devices During Transcatheter Aortic Valve Replacement.
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Singh V, Damluji AA, Mendirichaga R, Alfonso CE, Martinez CA, Williams D, Heldman AW, de Marchena EJ, O'Neill WW, and Cohen MG
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- Aged, Aged, 80 and over, Aortic Valve Stenosis diagnosis, Elective Surgical Procedures methods, Emergency Medical Services methods, Female, Hospital Mortality, Humans, Male, Outcome and Process Assessment, Health Care, Prospective Studies, Severity of Illness Index, Survival Analysis, United States epidemiology, Aortic Valve Stenosis surgery, Assisted Circulation instrumentation, Assisted Circulation methods, Assisted Circulation mortality, Cardiopulmonary Bypass instrumentation, Cardiopulmonary Bypass methods, Cardiopulmonary Bypass mortality, Elective Surgical Procedures statistics & numerical data, Emergency Medical Services statistics & numerical data, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement methods
- Abstract
Objective: Evaluate the use of mechanical circulatory support (MCS) devices in high-risk patients undergoing transcatheter aortic valve replacement (TAVR)., Background: The use of MCS devices in elderly patients with multiple comorbidities undergoing TAVR is underexplored., Methods: All patients undergoing TAVR at a single tertiary academic center who required MCS during index procedure between 2008 and 2015 were included in a prospective database., Results: MCS was used in 9.4% (54/577) of all TAVRs (n = 52 Edwards Sapien and n = 2 CoreValves) of which 68.5% (n = 37) were used as part of a planned strategy, and 31.5% (n = 17) were used in emergency "bail-out" situations. IABP was the most commonly used device (87%) followed by Impella and ECMO (6% each). Among the MCS group, 22% required cardiopulmonary resuscitation during the procedure (n = 4 elective [11%] vs. n = 8 emergent [47%]) and 15% upgrade to a second device (Impella or CPB after IABP; n = 5 elective [14%] vs. n = 3 emergent [18%]). Median duration of support was 1-day. Device related complications were low (4%). In-hospital mortality in this extremely high-risk population was 24% (13/54) (11% [4/37] for elective cases and 53% [9/17] for emergency cases). Cardiogenic shock (50%) was the most common cause of in-hospital death. Cumulative all-cause 1-year mortality was 35% (19/54) (19% 97/370 for elective and 71% [12/17] for emergency cases)., Conclusion: Emergent use of MCS during TAVR in extremely high-risk population is associated with high short and long-term mortality rates. Early identification of patients at risk for hemodynamic compromise may rationalize elective utilization of MCS during TAVR., (© 2016, Wiley Periodicals, Inc.)
- Published
- 2016
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16. Complications and Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement With Edwards SAPIEN & SAPIEN XT Valves: A Meta-Analysis of World-Wide Studies and Registries Comparing the Transapical and Transfemoral Accesses.
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Ghatak A, Bavishi C, Cardoso RN, Macon C, Singh V, Badheka AO, Padala S, Cohen MG, Mitrani R, O'Neill W, and De Marchena E
- Subjects
- Acute Kidney Injury etiology, Hemorrhage etiology, Humans, Pacemaker, Artificial, Renal Replacement Therapy, Stroke etiology, Transcatheter Aortic Valve Replacement adverse effects, Transcatheter Aortic Valve Replacement mortality, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement methods
- Abstract
Introduction: Both transfemoral (TF) and transapical (TA) routes are utilized for Transcatheter Aortic Valve Replacement (TAVR) using Edwards SAPIEN & SAPIEN XT valves. We intended to perform a meta-analysis comparing the complication rates between these two approaches in studies published before and after the standardized Valve Academic Research Consortium (VARC) definitions., Methods: We performed a comprehensive electronic database search for studies published until January 2014 comparing TF and TA approaches using the Edwards SAPIEN/SAPIEN XT aortic valve. Studies were analyzed based on the following endpoints: 1-year mortality, 30-day mortality, stroke, new pacemaker implantation, bleeding, and acute kidney injury., Results: Seventeen studies were included in the meta-analysis. Patients undergoing TA TAVR had a significantly higher logistic EuroSCORE (24.6 ± 12.9 vs. 21.3 ± 12.0; P < 0.001). The cumulative risks for 30-day mortality (RR 0.61; 95%CI 0.46-0.81; P = 0.001), 1-year mortality (RR 0.68; 95%CI 0.55-0.84; P < 0.001), and acute kidney injury (RR 0.53; 95%CI 0.38-0.73; P < 0.001) were significantly lower for patients undergoing TF as compared to TA approach. Both approaches had a similar incidence of 30-day stroke, pacemaker implantation, and major or life-threatening bleeding. Studies utilizing the VARC definitions and those pre-dating VARC yielded similar results., Conclusion: This meta-analysis demonstrates a decreased 30-day and 1-year mortality in TF TAVR as compared to TA TAVR. Post-procedure acute kidney injury and the need for renal replacement therapy are also significantly lower in the TF group. These differences hold true even after utilizing the standardized Valve Academic Research Consortium criteria., (© 2015, Wiley Periodicals, Inc.)
- Published
- 2015
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17. Clinical outcomes with on-label and off-label use of the transcatheter heart valve in the United States.
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Lardizabal JA, Macon CJ, O'Neill BP, Singh V, Martinez CA, Alfonso C, Cohen MG, Williams DB, O'Neill WW, and Heldman AW
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- Aged, 80 and over, Aortic Valve Stenosis mortality, Cause of Death trends, Female, Follow-Up Studies, Humans, Male, Prospective Studies, Risk Factors, Survival Rate trends, Treatment Outcome, United States epidemiology, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Risk Assessment, Transcatheter Aortic Valve Replacement methods
- Abstract
Objective: We explored the efficacy, safety, and clinical consequences of on-label and off-label transcatheter aortic valve replacement (TAVR) in the real-world setting., Background: The transcatheter heart valve (THV) was initially approved only for transfemoral (TF) delivery (on-label use) during TAVR in inoperable patients with severe aortic stenosis (AS). Because of lack of alternative options in TAVR-eligible patients with inadequate TF access, other routes have been utilized for THV implantation (off-label use), outcomes of which were previously unknown., Methods: Consecutive patients with severe inoperable AS who underwent clinical TAVR at our site were enrolled in a prospective database. Fifty subjects underwent TF-TAVR (on-label group), while non-TF routes were utilized in 60 subjects (off-label group). Procedural events, 30-day clinical outcomes, and 1-year all-cause mortality data were analyzed., Results: Technical device success was similar between on-label and off-label groups (88% vs. 87%, respectively; P = 0.92), as was the incidence of procedural complications and 30-day clinical events. The on-label group had lower 1-year all-cause death rate (12%) compared to the off-label group (32%; P = 0.02). The 1-year all-cause mortality in the off-label group was comparable to published clinical trial and registry data on TAVR, and appeared lower than historical outcomes with conservative medical therapy., Conclusion: On-label use of the THV in the real-world setting was associated with favorable survival outcomes compared to off-label TAVR and historical data. Off-label use of the THV appeared to be safe and effective when used in select patients with inoperable AS who are not eligible for TAVR via TF approach., (© 2014 Wiley Periodicals, Inc.)
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- 2014
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18. Impact of CMS coverage decision on access to transcatheter aortic valve replacement.
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O'Neill BP, O'Neill WW, Williams D, Cohen MG, Heldman AW, Macon C, Martinez CA, Alfonso CE, Clark PM, Velasquez O, Seo D, Clermont PG, and Moscucci M
- Subjects
- Aged, 80 and over, Aortic Valve Stenosis diagnosis, Aortic Valve Stenosis mortality, Cardiac Catheterization, Female, Follow-Up Studies, Humans, Male, Retrospective Studies, Risk Factors, Survival Rate trends, Transcatheter Aortic Valve Replacement economics, Treatment Outcome, United States epidemiology, Aortic Valve Stenosis surgery, Centers for Medicare and Medicaid Services, U.S. statistics & numerical data, Transcatheter Aortic Valve Replacement methods
- Abstract
Objectives: To assess the impact of the Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) on access for patients with aortic stenosis (AS) with transcatheter aortic valve replacement (TAVR) in a tertiary care center., Background: TAVR has given hope to patients with AS who are deemed inoperable. The effects of the NCD on access to patients with AS has not been evaluated., Materials and Methods: A total of 94 inoperable AS patients were evaluated and treated from December 2011 through June of 2012 with TAVR. Patients who underwent transfemoral (TF) vs. non-TF access were compared. The CMS NCD was released on May 1, 2012 and on July 1, 2012, the nontransfemoral access program was put on hold due to lack of reimbursement., Results: Patients in the TF (n = 33) and non-TF access (n = 61) groups were similar in age (85.2 ± 6.3 vs. 84.8 ± 6.6 P = 0.74) and STS mortality (9.38 ± 5.33 vs. 7.91 ± 3.69, P = 0.074). The iliofemoral arteries were larger diameter in the TF group (7.72 ± 1.49 vs. 6.21 ± 1.78, P < 0.001) and males (7.39 ± 1.81 vs. 6.1 ± 1.61 P < 0.001). More women underwent valve implantation via non-TF access (73 vs. 23%, P = 0.03). After the NCD, 21 patients who previously qualified for non-TF TAVR would not be reimbursed by CMS. Four died soon after., Conclusions: After the NCD, the proportion of inoperable patients with severe AS that can be treated with TAVR was greatly reduced due the lack of reimbursement for TAVR via non-TF access. This effect is particularly pronounced in women. © 2014 Wiley Periodicals, Inc., (© 2014 Wiley Periodicals, Inc.)
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- 2014
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19. TAVR in Low-Population Density Areas: Assessing Healthcare Access for Older Adults with Severe Aortic Stenosis
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Damluji, Abdulla A, Fabbro, Michael, Epstein, Richard H, Rayer, Stefan, Wang, Ying, Moscucci, Mauro, Cohen, Mauricio G, Carroll, John D, Messenger, John C, Resar, Jon R, Cohen, David J, Sherwood, Matthew W, O’Connor, Christopher M, and Batchelor, Wayne
- Subjects
Aged, 80 and over ,Male ,Population Density ,Travel ,Time Factors ,Databases, Factual ,Age Factors ,Aortic Valve Stenosis ,Severity of Illness Index ,Article ,Health Services Accessibility ,Transcatheter Aortic Valve Replacement ,Treatment Outcome ,Catchment Area, Health ,Residence Characteristics ,Florida ,Humans ,Female ,Hospital Mortality ,Rural Health Services ,Healthcare Disparities ,Aged ,Retrospective Studies - Abstract
BACKGROUND: Restricting TAVR to centers based on volume thresholds alone can potentially create unintended disparities in healthcare access. We aimed to compare the influence of population density in state of Florida in regard to access to TAVR, TAVR-utilization rates, and in-hospital mortality. METHODS AND RESULTS: From 2011–2016, we used data from the AHCA to calculate travel time and distance for each TAVR-patient by comparing their home address to their TAVR-facility ZIP-code. Travel time and distance, TAVR rates, and mortality were compared across categories of low to high population density (population per sq. mi of land). Of the 6,531 patients included, the mean (SD) age was 82 (9) years, 43% were female and 91% were Caucasian. Patients residing in the lowest category (
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- 2020
20. The Transaortic Approach for Transcatheter Aortic Valve Replacement Initial Clinical Experience in the United States
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Lardizabal, Joel A., O'Neill, Brian P., Desai, Harit V., Macon, Conrad J., Rodriguez, Alexis P., Martinez, Claudia A., Alfonso, Carlos E., Bilsker, Martin S., Carillo, Roger G., Cohen, Mauricio G., Heldman, Alan W., O'Neill, William W., and Williams, Donald B.
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direct aortic ,transaortic ,transcatheter aortic valve replacement - Abstract
ObjectivesThis study sought to investigate the technical feasibility and safety of the transaortic (TAO) transcatheter aortic valve replacement (TAVR) approach in patients not eligible for transfemoral (TF) access by using a device commercially available in the United States.BackgroundA large proportion of candidates for TAVR have inadequate iliofemoral vessels for TF access. The transapical route (TAP) is the current alternative but is associated with less favorable outcomes. Other access options need to be explored.MethodsForty-four consecutive patients with inoperable, severe aortic stenosis underwent TAO TAVR in our institution. Procedural and 30-day clinical outcomes data were compared with data from 76 consecutive patients who underwent TAP TAVR at our site. Technical learning curves were assessed by comparing outcomes of the first 20 cases with the subsequent patients who underwent each procedure.ResultsThe TAO and TAP TAVR groups were similar in terms of device success according to Valve Academic Research Consortium criteria (89% vs. 84%; p = 0.59) and rates of the 30-day combined safety endpoint of all-cause mortality, myocardial infarction, major stroke, disabling bleeding, severe acute kidney injury, and valve reintervention (20% vs. 33%; p = 0.21). The TAO approach, compared with TAP TAVR, was associated with lower combined bleeding and vascular event rate (27% vs. 46%; p = 0.05), shorter median intensive care unit length of stay (3 vs. 6 days; p = 0.01), and a favorable learning curve.ConclusionsTAVR via the TAO approach is technically feasible, seems to be associated with favorable outcomes, and expands the current alternative options for access sites in patients with inoperable aortic stenosis who are ineligible for TF TAVR.
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21. New-Onset Atrial Fibrillation After Aortic Valve Replacement Comparison of Transfemoral, Transapical, Transaortic, and Surgical Approaches
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Tanawuttiwat, Tanyanan, O'Neill, Brian P., Cohen, Mauricio G., Chinthakanan, Orawee, Heldman, Alan W., Martinez, Claudia A., Alfonso, Carlos E., Mitrani, Raul D., Macon, Conrad J., Carrillo, Roger G., Williams, Donald B., O'Neill, William W., and Myerburg, Robert J.
- Subjects
transcatheter aortic valve replacement ,atrial fibrillation - Abstract
ObjectivesThis study sought to determine the incidence of new-onset atrial fibrillation (AF) associated with different methods of isolated aortic valve replacement (AVR)—transfemoral (TF), transapical (TA), and transaortic (TAo) catheter-based valve replacement and conventional surgical approaches.BackgroundThe relative incidences of AF associated with the various access routes for AVR have not been well characterized.MethodsIn this single-center, retrospective cohort study, we evaluated a total of 231 consecutive patients who underwent AVR for degenerative aortic stenosis (AS) between March 2010 and September 2012. Patients with a history of paroxysmal, persistent, or chronic AF, with bicuspid aortic valves, and patients who died within 48 h after AVR were excluded. A total of 123 patients (53% of total group) qualified for inclusion. Data on documented episodes of new-onset AF, along with all clinical, echocardiographic, procedural, and 30-day follow-up data, were collated.ResultsAF occurred in 52 patients (42.3%). AF incidence varied according to the procedural method. AF occurred in 60% of patients who underwent surgical AVR (SAVR), in 53% after TA-TAVR, in 33% after TAo-TAVR cases, and 14% after TF-TAVR. The episodes occurred at a median time interval of 53 (25th to 75th percentile, 41 to 87) h after completion of the procedure. Procedures without pericardiotomy had an 82% risk reduction of AF compared with those with pericardiotomy (adjusted odds ratio: 0.18; 95% confidence interval: 0.05 to 0.59).ConclusionsAF was a common complication of AVR with a cumulative incidence of >40% in elderly patients with degenerative AS who underwent either SAVR or TAVR. AF was most common with SAVR and least common with TF-TAVR. Procedures without pericardiotomy were associated with a lower incidence of AF.
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22. New-Onset Atrial Fibrillation After Aortic Valve Replacement: Comparison of Transfemoral, Transapical, Transaortic, and Surgical Approaches.
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Tanawuttiwat, Tanyanan, O'Neill, Brian P., Cohen, Mauricio G., Chinthakanan, Orawee, Heldman, Alan W., Martinez, Claudia A., Alfonso, Carlos E., Mitrani, Raul D., Macon, Conrad J., Carrillo, Roger G., Williams, Donald B., O'Neill, William W., and Myerburg, Robert J.
- Subjects
- *
ATRIAL fibrillation , *SURGERY , *AORTIC stenosis , *RETROSPECTIVE studies , *COHORT analysis , *PATIENTS ,AORTIC valve surgery - Abstract
Objectives: This study sought to determine the incidence of new-onset atrial fibrillation (AF) associated with different methods of isolated aortic valve replacement (AVR)—transfemoral (TF), transapical (TA), and transaortic (TAo) catheter-based valve replacement and conventional surgical approaches. Background: The relative incidences of AF associated with the various access routes for AVR have not been well characterized. Methods: In this single-center, retrospective cohort study, we evaluated a total of 231 consecutive patients who underwent AVR for degenerative aortic stenosis (AS) between March 2010 and September 2012. Patients with a history of paroxysmal, persistent, or chronic AF, with bicuspid aortic valves, and patients who died within 48 h after AVR were excluded. A total of 123 patients (53% of total group) qualified for inclusion. Data on documented episodes of new-onset AF, along with all clinical, echocardiographic, procedural, and 30-day follow-up data, were collated. Results: AF occurred in 52 patients (42.3%). AF incidence varied according to the procedural method. AF occurred in 60% of patients who underwent surgical AVR (SAVR), in 53% after TA-TAVR, in 33% after TAo-TAVR cases, and 14% after TF-TAVR. The episodes occurred at a median time interval of 53 (25th to 75th percentile, 41 to 87) h after completion of the procedure. Procedures without pericardiotomy had an 82% risk reduction of AF compared with those with pericardiotomy (adjusted odds ratio: 0.18; 95% confidence interval: 0.05 to 0.59). Conclusions: AF was a common complication of AVR with a cumulative incidence of >40% in elderly patients with degenerative AS who underwent either SAVR or TAVR. AF was most common with SAVR and least common with TF-TAVR. Procedures without pericardiotomy were associated with a lower incidence of AF. [Copyright &y& Elsevier]
- Published
- 2014
- Full Text
- View/download PDF
23. The Transaortic Approach for Transcatheter Aortic Valve Replacement: Initial Clinical Experience in the United States.
- Author
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Lardizabal, Joel A., O'Neill, Brian P., Desai, Harit V., Macon, Conrad J., Rodriguez, Alexis P., Martinez, Claudia A., Alfonso, Carlos E., Bilsker, Martin S., Carillo, Roger G., Cohen, Mauricio G., Heldman, Alan W., O'Neill, William W., and Williams, Donald B.
- Abstract
Objectives: This study sought to investigate the technical feasibility and safety of the transaortic (TAO) transcatheter aortic valve replacement (TAVR) approach in patients not eligible for transfemoral (TF) access by using a device commercially available in the United States. Background: A large proportion of candidates for TAVR have inadequate iliofemoral vessels for TF access. The transapical route (TAP) is the current alternative but is associated with less favorable outcomes. Other access options need to be explored. Methods: Forty-four consecutive patients with inoperable, severe aortic stenosis underwent TAO TAVR in our institution. Procedural and 30-day clinical outcomes data were compared with data from 76 consecutive patients who underwent TAP TAVR at our site. Technical learning curves were assessed by comparing outcomes of the first 20 cases with the subsequent patients who underwent each procedure. Results: The TAO and TAP TAVR groups were similar in terms of device success according to Valve Academic Research Consortium criteria (89% vs. 84%; p = 0.59) and rates of the 30-day combined safety endpoint of all-cause mortality, myocardial infarction, major stroke, disabling bleeding, severe acute kidney injury, and valve reintervention (20% vs. 33%; p = 0.21). The TAO approach, compared with TAP TAVR, was associated with lower combined bleeding and vascular event rate (27% vs. 46%; p = 0.05), shorter median intensive care unit length of stay (3 vs. 6 days; p = 0.01), and a favorable learning curve. Conclusions: TAVR via the TAO approach is technically feasible, seems to be associated with favorable outcomes, and expands the current alternative options for access sites in patients with inoperable aortic stenosis who are ineligible for TF TAVR. [Copyright &y& Elsevier]
- Published
- 2013
- Full Text
- View/download PDF
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