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Claret Medical raises $21m
Claret Medical has raised $21.2 million in a new round of equity financing, according to an SEC filing posted this week. The Santa Rosa, Calif.-based company is not seeking to raise any more funds in the round and has not yet stated how it plans to spend the funds it raised. Money in the round came from 35 anonymous investors, according to the SEC filing, with the 1st sale noted on June 22. Earlier this week, Claret Medical released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortali...
Source: Mass Device - October 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news

Restrictive Mitral Valve Annuloplasty: Prognostic Implications of Left Ventricular Forward Flow
Conclusions In patients with severe secondary MR treated with surgical repair, LV forward flow was independently associated with better survival and lower risk of the combined endpoint.
Source: The Annals of Thoracic Surgery - October 18, 2017 Category: Cardiovascular & Thoracic Surgery Source Type: research

Outcomes of Elective Aortic Hemiarch Reconstruction for Aneurysmal Disease in the Elderly
Conclusions Although elderly patients have a more prolonged recovery after elective aortic hemiarch reconstruction for aneurysmal disease, outcomes are acceptable with low operative mortality and with the majority being discharged home. Moderate hypothermic circulatory arrest with antegrade cerebral perfusion is a safe strategy for this cohort. Advanced age alone should not be viewed as a contraindication in these cases.
Source: The Annals of Thoracic Surgery - October 18, 2017 Category: Cardiovascular & Thoracic Surgery Source Type: research

Association of Chronic Kidney Disease With In-Hospital Outcomes of Transcatheter Aortic Valve Replacement
Conclusions Patients with CKD or ESRD have worse in-hospital outcomes after TAVR. AKI is associated with higher in-hospital mortality in patients undergoing TAVR and the incidence of AKI has not declined over the years.
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - October 16, 2017 Category: Cardiology Authors: Gupta, T., Goel, K., Kolte, D., Khera, S., Villablanca, P. A., Aronow, W. S., Bortnick, A. E., Slovut, D. P., Taub, C. C., Kizer, J. R., Pyo, R. T., Abbott, J. D., Fonarow, G. C., Rihal, C. S., Garcia, M. J., Bhatt, D. L. Tags: Structural Source Type: research

Early Right Ventricular Assist Device Use in Patients Undergoing Continuous-Flow Left Ventricular Assist Device Implantation: Incidence and Risk Factors From the Interagency Registry for Mechanically Assisted Circulatory Support Original Articles
Conclusions: The need for RVAD implantation after LVAD is associated with indices of global illness severity, markers of end-organ dysfunction, and profiles of hemodynamic instability.
Source: Circulation: Heart Failure - October 11, 2017 Category: Cardiology Authors: Kiernan, M. S., Grandin, E. W., Brinkley, M., Kapur, N. K., Pham, D. T., Ruthazer, R., Rame, J. E., Atluri, P., Birati, E. Y., Oliveira, G. H., Pagani, F. D., Kirklin, J. K., Naftel, D., Kormos, R. L., Teuteberg, J. J., DeNofrio, D. Tags: Heart Failure, Cardiovascular Surgery Original Articles Source Type: research

Randomized comparison of balloon aortic valvuloplasty performed with or without rapid cardiac pacing: The pacing versus no pacing (PNP) study
ConclusionsRapid ventricular pacing did not influence BAV efficacy or safety and tolerance was slightly worse.
Source: Journal of Interventional Cardiology - October 11, 2017 Category: Cardiology Authors: Gianni Dall'Ara, Antonio Marzocchi, Nevio Taglieri, Carolina Moretti, Giulio Rodin ò, Matteo Chiarabelli, Paolo Bottoni, Cinzia Marrozzini, Maria Rita Sabattini, Maria‐Letizia Bacchi‐Reggiani, Claudio Rapezzi, Francesco Saia Tags: RANDOMIZED TRIAL Source Type: research

Impact of flow, gradient, and left ventricular function on outcomes after transcatheter aortic valve replacement
ConclusionsIn patients undergoing TAVR, low flow was an independent predictor of 1‐year mortality and HF, and a stronger predictor than either low AVG or LVEF. Patients with low flow and preserved EF had increased mortality and HF at 1‐year, while those with low flow and reduced EF had outcomes similar to patients with normal flow.
Source: Catheterization and Cardiovascular Interventions - October 8, 2017 Category: Cardiovascular & Thoracic Surgery Authors: Edward T. Carreras, Tsuyoshi Kaneko, Fernando Ramirez ‐Del Val, Marc P. Pelletier, Piotr S. Sobieszczyk, Deepak L. Bhatt, Pinak B. Shah Tags: VALVULAR AND STRUCTURAL HEART DISEASES Source Type: research

Transcatheter or surgical aortic valve replacement in patients with advanced kidney disease: A propensity score –matched analysis
ConclusionsIn patients with advanced kidney disease, SAVR was associated with higher mortality and higher periprocedural complications, as compared with TAVR. Thus, benefits of TAVR could be extended in patients with advanced kidney disease who cannot undergo surgery.
Source: Clinical Cardiology - October 1, 2017 Category: Cardiology Authors: Rajkumar Doshi, Jay Shah, Vaibhav Patel, Varun Jauhar, Perwaiz Meraj Tags: CLINICAL INVESTIGATIONS Source Type: research

Metoprolol Reduces Hemodynamic and Metabolic Overload in Asymptomatic Aortic Valve Stenosis Patients: A Randomized Trial Ventricular Structure and Function
Conclusions— In patients with asymptomatic AS, metoprolol increases systolic ejection time and reduces aortic valve gradients, global afterload, and myocardial oxygen requirements. Thus, metoprolol displays favorable hemodynamic and metabolic effects and could improve outcome in patients with asymptomatic AS. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT02076711.
Source: Circulation: Cardiovascular Imaging - September 27, 2017 Category: Radiology Authors: Hansson, N. H., Sorensen, J., Harms, H. J., Kim, W. Y., Nielsen, R., Tolbod, L. P., Frokiaer, J., Bouchelouche, K., Dodt, K. K., Sihm, I., Poulsen, S. H., Wiggers, H. Tags: Clinical Studies, Metabolism, Valvular Heart Disease, Imaging, Nuclear Cardiology and PET Ventricular Structure and Function Source Type: research

Short-Term Outcome and Hemodynamic Performance of Next-Generation Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valves in Patients With Small Aortic Annulus: A Multicenter Propensity-Matched Comparison Structural Heart Disease
Conclusions— Albeit a similar safety profile with low clinical event rates, transcatheter aortic valve replacement with the ACURATE neo valve resulted in lower transvalvular gradients and consequently less prosthesis–patient mismatch compared with the SAPIEN 3 in patients with small annulus. These results emphasize the need of careful prosthesis selection in each individual patient.
Source: Circulation: Cardiovascular Interventions - September 26, 2017 Category: Cardiology Authors: Mauri, V., Kim, W. K., Abumayyaleh, M., Walther, T., Moellmann, H., Schaefer, U., Conradi, L., Hengstenberg, C., Hilker, M., Wahlers, T., Baldus, S., Rudolph, V., Madershahian, N., Rudolph, T. K. Tags: Aortic Valve Replacement/Transcatheter Aortic Valve Implantation Structural Heart Disease Source Type: research

Edwards Lifesciences has ‘ key events ’ around TAVR this week
Edwards Lifesciences is planning some important TAVR reveals during the PCR London Valves 2017 course that is underway. The Irvine, Calif.–based cardio devices company said yesterday that it plans to introduce the new Sapien 3 Ultra valve during the event, which runs until tomorrow. Edwards officials expect the Sapien 3 Ultra to receive CE Mark by the end of the year, with plans for a U.S. introduction in late 2018. For the Ultra, they’ve added a taller skirt to the Sapien 3 design to improve TAVR outcomes, according to the company. Edwards has incorporated the taller skirt initially with sizes 20, 23 and 26 mm. A...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular Catheters Clinical Trials Edwards Lifesciences tavr Source Type: news

Comparative outcomes of transcatheter aortic valve replacement in African American and Caucasian patients with severe aortic stenosis
ConclusionsThere was no significant difference in the utilization rates, in‐hospital outcomes, and cost of TAVR between Caucasians and AA patients in contemporary US practice. Further comparative studies of surgical and TAVR in AAs and other racial minorities are warranted.
Source: Catheterization and Cardiovascular Interventions - September 23, 2017 Category: Cardiovascular & Thoracic Surgery Authors: Fahad Alqahtani, Sami Aljohani, Ahmad Almustafa, Mohammed Alhijji, Oluseun Ali, David R. Holmes, Mohamad Alkhouli Tags: VALVULAR AND STRUCTURAL HEART DISEASES Source Type: research

Transcatheter Aortic Valve Replacement: Outcomes, Indications, Complications, and Innovations
Opinion statementTranscatheter aortic valve replacement (TAVR) has become the standard of care for the treatment of severe aortic stenosis in individuals who are at prohibitive surgical risk and presents a viable alternative to surgery in selected patients who are at high operative risk. To date, outcomes from the PARTNER (Placement of AoRtic TraNscathetER Valve) and Medtronic CoreValve ® US Pivotal trials continue to show the benefits of TAVR in these high-risk subgroups out to 5 and 3 years, respectively (as reported by Mack et al. Lancet. 85:2477–2484 2015; Kapadia et al. Lancet. 385:2485–2491 2015; Deeb et al. J ...
Source: Current Treatment Options in Cardiovascular Medicine - September 22, 2017 Category: Cardiology Source Type: research

Medtronic launches post-market study of CoreValve Evolut Pro heart valve
Medtronic (NYSE:MDT) said today it launched a post-market clinical study of its CoreValve Evolut Pro valve, looking to evaluate performance out to 5 years for the self-expanding transcather aortic valve implantation system. The multi-center, prospective single-arm study aims to enroll 600 patients across 35 European sites to evaluate the safety of the CoreValve Evolut Pro, including all-cause mortality and all stroke at 30 days and clinical performance including valve hemodynamics and paravalvular regurgitation. “We look forward to replicating the excellent clinical outcomes demonstrated by the Evolut Pro valve in a...
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Claret Medical touts Sentinel data in TAVR study
Claret Medical today released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortality rates. The study of the device was recently published in the Journal of the American College of Cardiology: Cardiovascular Interventions, the Santa Rosa, Calif.-based company said. The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medical touts as the 1st and only FDA-cleared device to do so. “In pat...
Source: Mass Device - September 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Neurological Claret Medical Inc. Source Type: news

Characteristics and Outcome Following Transcatheter Aortic Valve Replacement of Patients with Severe Aortic Stenosis with Low Flow.
CONCLUSIONS: Patients with HG and those with NF-LG have low 1-year mortality rates following TAVR, whereas those with classical LF-LG and LEF and those with paradoxical LF-LG and NEF have high and intermediate risk of mortality, respectively. In contradiction to previous reports, LG but not LF or LEF is an independent predictor of late mortality in high-risk patients with severe AS undergoing TAVR. PMID: 28870874 [PubMed - as supplied by publisher]
Source: EuroIntervention - September 7, 2017 Category: Cardiovascular & Thoracic Surgery Tags: EuroIntervention Source Type: research

An autopsy case of aortic root rupture with thin porcelain aorta during balloon-expandable transcatheter aortic valve implantation
We present a case of aortic root rupture caused by unusually fragile aortic wall during TAVI and the lesson from the autopsy results.>
Source: Journal of Cardiology Cases - September 6, 2017 Category: Cardiology Source Type: research

Minimally Invasive Access Aortic Arch Surgery
Conclusions: Minimally invasive aortic arch surgery via partial upper sternotomy does not increase the risk of morbidity or mortality. Thus, in experienced hands, it is viable, safe, and therefore favorable and as a result should be offered to more patients.
Source: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery - September 1, 2017 Category: Cardiovascular & Thoracic Surgery Tags: Original Articles Source Type: research

Comparison of del Nido Cardioplegia With Blood Cardioplegia in Adult Combined Surgery
Conclusions: The DNS can be used as an alternative to BS in adult concomitant aortic valve replacement + CABG surgery. This supports our hypothesis that in this specific setting, DNS provides comparable myocardial protection as BS, with possibly shorter cardiopulmonary bypass and cross-clamp times.
Source: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery - September 1, 2017 Category: Cardiovascular & Thoracic Surgery Tags: Original Articles Source Type: research

Clinical outcome in nonagenarians undergoing transcatheter valve replacement.
CONCLUSION: Our case series demonstrate that even with elevated comorbidity index, clinical endpoints and valve-associated results are relatively favorable in nonagenarians treated with TAVR. PMID: 29054182 [PubMed - in process]
Source: Indian Heart J - September 1, 2017 Category: Cardiology Authors: Mendiz O, Fava C, Cura F, Agatiello C, Sztejfman M, Damonte A, Londero H, Candiello A, Berrocal D Tags: Indian Heart J Source Type: research

Conscious Sedation versus General Anesthesia for Transcatheter Aortic Valve Replacement: Insights from the NCDR ® STS/ACC TVT Registry.
Conclusions -In U.S. practice, conscious sedation is associated with briefer length of stay and lower in-hospital and 30-day mortality compared to TAVR with general anesthesia in both unadjusted and adjusted analyses. These results suggest the safety of conscious sedation in this population, though comparative effectiveness analyses using observational data cannot definitively establish the superiority of one technique over another. PMID: 28864443 [PubMed - as supplied by publisher]
Source: Circulation - September 1, 2017 Category: Cardiology Authors: Hyman MC, Vemulapalli S, Szeto WY, Stebbins A, Patel PA, Matsouaka RA, Herrmann HC, Anwaruddin S, Kobayashi T, Desai ND, Vallabhajosyula P, McCarthy FH, Li R, Bavaria JE, Giri J Tags: Circulation Source Type: research

Florida Sleeve Procedure Is Durable and Improves Aortic Valve Function in Marfan Syndrome Patients.
CONCLUSIONS: The FS procedure can be performed safely in Marfan syndrome patients with immediate improvement in aortic valve function. Long-term survival and freedom from reoperation rates are encouraging. PMID: 28410640 [PubMed - indexed for MEDLINE]
Source: The Annals of Thoracic Surgery - September 1, 2017 Category: Cardiovascular & Thoracic Surgery Authors: Aalaei-Andabili SH, Martin T, Hess P, Klodell C, Karimi A, Arnaoutakis G, Lee T, Beaver T Tags: Ann Thorac Surg Source Type: research

Early Lessons on Bundled Payment at an Academic Medical Center.
CONCLUSION: Opportunities for savings under bundled payment may be greater for lower extremity joint arthroplasty than for other conditions. PMID: 28837458 [PubMed - in process]
Source: The Journal of the American Academy of Orthopaedic Surgeons - August 25, 2017 Category: Orthopaedics Tags: J Am Acad Orthop Surg Source Type: research

Transcatheter vs Surgical Aortic Valve Replacement for Aortic Stenosis in Low-Intermediate Risk Patients: A Meta-analysis
Conclusions Although there was no difference in 30-day and late mortality, the rate of complications differed between TAVR and SAVR in the low-intermediate surgical risk population.
Source: Canadian Journal of Cardiology - August 25, 2017 Category: Cardiology Source Type: research

Minimally Invasive Versus Transcatheter and Surgical Aortic Valve Replacement: A Propensity Matched Study.
CONCLUSIONS: During recent years, MIAVR and TFTAVR have experienced significant growth in volume with near-comparable short-term outcomes, while SAVR and TA-TAVR volumes have declined. These results underscore the importance of surgeons adopting MIAVR and TF-TAVR techniques in order to offer patients optimal outcomes. PMID: 28820543 [PubMed - in process]
Source: Journal of Heart Valve Disease - August 20, 2017 Category: Cardiology Tags: J Heart Valve Dis Source Type: research

Transcatheter aortic valve implantation compared with surgical aortic valve replacement in patients with anaemia.
CONCLUSIONS: These results suggest that TAVI is not superior to SAVR in patients with anaemia. PMID: 28812435 [PubMed - as supplied by publisher]
Source: Acta Cardiologica - August 17, 2017 Category: Cardiology Tags: Acta Cardiol Source Type: research

Surgical Treatment of Atrial Fibrillation in Patients with Rheumatic Valve Disease
Conclusion: Atrial fibrillation ablation surgery with surgical approach of rheumatic mitral valve resulted in 63.1% patients in sinus rhythm after one year. Discharge from hospital in sinus rhythm was a predictor of maintenance of this rhythm. Increased left atrium and use of unipolar radiofrequency were associated with lower chance of sinus rhythm. Operative mortality rate of 7.7% and survival and stroke-free survival contribute to excellent care results for this approach.
Source: Revista Brasileira de Cirurgia Cardiovascular - August 17, 2017 Category: Cardiovascular & Thoracic Surgery Source Type: research

Intraoperative Cerebral Perfusion Disturbances During Transcatheter Aortic Valve Replacement.
CONCLUSIONS: Cerebral oximetry reacted promptly to rapid ventricular pacing with significant desaturation and hyperemia a common occurrence. However, no association between this intraoperative insult and objective neurologic injury was detected. PMID: 28821337 [PubMed - as supplied by publisher]
Source: The Annals of Thoracic Surgery - August 16, 2017 Category: Cardiovascular & Thoracic Surgery Authors: Fanning JP, Walters DL, Wesley AJ, Anstey C, Huth S, Bellapart J, Collard C, Rapchuk IL, Natani S, Savage M, Fraser JF Tags: Ann Thorac Surg Source Type: research

Intraoperative Cerebral Perfusion Disturbances During Transcatheter Aortic Valve Replacement
Conclusions Cerebral oximetry reacted promptly to rapid ventricular pacing with significant desaturation and hyperemia a common occurrence. However, no association between this intraoperative insult and objective neurologic injury was detected.
Source: The Annals of Thoracic Surgery - August 16, 2017 Category: Cardiovascular & Thoracic Surgery Source Type: research

Surgical Treatment of Atrial Fibrillation in Patients with Rheumatic Valve Disease
Objective: To assess heart rhythm and predictive factors associated with sinus rhythm after one year in patients with rheumatic valve disease undergoing concomitant surgical treatment of atrial fibrillation. Operative mortality, survival and occurrence of stroke after one year were also evaluated.Methods: Retrospective longitudinal observational study of 103 patients undergoing rheumatic mitral valve surgery and ablation of atrial fibrillation using uni- or bipolar radiofrequency between January 2013 and December 2014. Age, gender, functional class (NYHA), type of atrial fibrillati...
Source: Brazilian Journal of Cardiovascular Surgery - August 14, 2017 Category: Cardiology Source Type: research

The impact of global left ventricular afterload on left ventricular reverse remodeling after aortic valve replacement
ConclusionsThe postoperative Zva was significantly associated with LV mass regression after AVR. Maintaining low global LV afterload following AVR may enhance LV reverse remodeling.
Source: Journal of Cardiac Surgery - August 11, 2017 Category: Cardiovascular & Thoracic Surgery Authors: Hisato Ito, Toru Mizumoto, Yu Shomura, Yasuhiro Sawada, Ko Kajiyama, Hideto Shimpo Tags: ORIGINAL ARTICLE Source Type: research

Low-Flow Severe Aortic Stenosis: Evolving Role of Transcatheter Aortic Valve Replacement Advances in Interventional Cardiology
The definition of severe aortic stenosis has classically and retrospectively been based on the natural history of patients with medically managed aortic stenosis and preserved left ventricular function in an era where surgical aortic valve replacement was the sole therapy. We now recognize that this disease is more heterogeneous and includes important subsets of patients with low stroke volume index (low flow) and low-gradient with reduced (classical) or preserved (paradoxical) ejection fraction. These patients pose diagnostic and treatment dilemmas, requiring a comprehensive assessment with integration of multimodality im...
Source: Circulation: Cardiovascular Interventions - August 9, 2017 Category: Cardiology Authors: Saybolt, M. D., Fiorilli, P. N., Gertz, Z. M., Herrmann, H. C. Tags: Valvular Heart Disease, Catheter-Based Coronary and Valvular Interventions Advances in Interventional Cardiology Source Type: research

Lower Transaortic Flow Rate Is Associated With Increased Mortality in Aortic Valve Stenosis
Conclusions In patients with AS without known cardiovascular disease or diabetes, low transaortic FR was independently associated with higher rates of cardiovascular and all-cause mortality. (An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart) (MK-0653A-043 AM4); NCT00092677)
Source: Journal of the American College of Cardiology: Cardiovascular Imaging - August 7, 2017 Category: Radiology Authors: Saeed, S., Senior, R., Chahal, N. S., Lonnebakken, M. T., Chambers, J. B., Bahlmann, E., Gerdts, E. Tags: Original Research Source Type: research

Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family
Conclusions Across all valve sizes, use of the repositionable Portico transcatheter aortic valve replacement system resulted in safe and effective treatment of aortic stenosis in high-risk patients.
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - August 7, 2017 Category: Cardiology Authors: Möllmann, H., Linke, A., Holzhey, D. M., Walther, T., Manoharan, G., Schäfer, U., Heinz-Kuck, K., Van Boven, A. J., Redwood, S. R., Kovac, J., Butter, C., Sondergaard, L., Lauten, A., Schymik, G., Worthley, S. G. Tags: Structural: Aortic Valve Focus Source Type: research

CT-Defined Prosthesis-Patient Mismatch Downgrades Frequency and Severity, and Demonstrates No Association With Adverse Outcomes After Transcatheter Aortic Valve Replacement
Conclusions EOAiCT downgrades frequency and severity of PPM in patients after TAVR, and was not associated with mortality 1 year after TAVR. EOAiTTE, but not EOAiCT, was associated with less left ventricular mass regression.
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - August 7, 2017 Category: Cardiology Authors: Mooney, J., Sellers, S. L., Blanke, P., Pibarot, P., Hahn, R. T., Dvir, D., Douglas, P. S., Weissman, N. J., Kodali, S. K., Thourani, V. H., Jilaihawi, H., Khalique, O., Smith, C. R., Kueh, S. H., Ohana, M., Grover, R., Naoum, C., Crowley, A., Jaber, W. A Tags: Structural: Aortic Valve Focus Source Type: research

Transcatheter Aortic Valve Implantation Versus Re-do Surgery for Failing Surgical Aortic Bioprosthesis: a Multi-Centre Propensity Score Analysis.
CONCLUSIONS: Patients with aortic bioprosthesis failure treated with either redo-SAVR or TAV-in-SAV have similar 30-day and 1-year clinical outcomes. PMID: 28760721 [PubMed - as supplied by publisher]
Source: EuroIntervention - August 3, 2017 Category: Cardiovascular & Thoracic Surgery Tags: EuroIntervention Source Type: research

Keystone Heart looks to launch 3rd-gen TriGuard trials in 2017
Keystone Heart  said yesterday it plans to launch a clinical trial of a 3rd-generation TriGuard cerebral embolic protection device by the end of the year. The Israel-based company said the new device, dubbed the TriGuard 3, will offer technological improvements over previous versions of the device, and that it has accelerated the development program of the device. Keystone Heart’s TriGuard devices are designed to protect the brain from emboli during transcatheter aortic valve replacement and other heart procedures to reduce stroke risk and brain damage. The TriGuard 3 is designed to be anatomy independent and for a ...
Source: Mass Device - August 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Neurological Research & Development Keystone Heart Source Type: news

Optimized Screening of Coronary Artery Disease With Invasive Coronary Angiography and Ad Hoc Percutaneous Coronary Intervention During Transcatheter Aortic Valve Replacement Structural Heart Disease
Conclusions— In patients undergoing TAVR, screening of CAD with invasive coronary angiography and ad hoc PCI during TAVR is feasible and was not associated with increased periprocedural risks. PCI followed by TAVR in the same session had similar outcomes than TAVR in which PCI was not performed.
Source: Circulation: Cardiovascular Interventions - August 2, 2017 Category: Cardiology Authors: Barbanti, M., Todaro, D., Costa, G., Pilato, G., Picci, A., Gulino, S., Capranzano, P., La Spina, K., Di Simone, E., DArrigo, P., Deste, W., Indelicato, A., Cannata, S., Giannazzo, D., Imme, S., Tamburino, C., Patane, M., Buccheri, S., Capodanno, D., Sgro Tags: Diagnostic Testing, Aortic Valve Replacement/Transcatheter Aortic Valve Implantation Structural Heart Disease Source Type: research

Mitro-aortic pathology: a  point of view for a fully transcatheter staged approach.
Mitro-aortic pathology: a point of view for a fully transcatheter staged approach. Neth Heart J. 2017 Aug 02;: Authors: D'Ancona G, Paranskaya L, Öner A, Kische S, Ince H Abstract Severe aortic valve stenosis (AVS) and mitral valve regurgitation (MVR) often coexist. Although a fully percutaneous treatment for the two conditions, by means of transcatheter aortic valve implantation (TAVI) followed by MitraClip, can be appealing in selected high-risk candidates, critical and strategical reasoning should be applied. In a 3-year period we have developed a single-centre experience of 14 patients who ...
Source: Netherlands Heart Journal - August 2, 2017 Category: Cardiology Authors: D'Ancona G, Paranskaya L, Öner A, Kische S, Ince H Tags: Neth Heart J Source Type: research

Image-based immersed boundary model of the aortic root.
Abstract Each year, approximately 300,000 heart valve repair or replacement procedures are performed worldwide, including approximately 70,000 aortic valve replacement surgeries in the United States alone. Computational platforms for simulating cardiovascular devices such as prosthetic heart valves promise to improve device design and assist in treatment planning, including patient-specific device selection. This paper describes progress in constructing anatomically and physiologically realistic immersed boundary (IB) models of the dynamics of the aortic root and ascending aorta. This work builds on earlier IB mod...
Source: Physica Medica - August 1, 2017 Category: Physics Authors: Hasan A, Kolahdouz EM, Enquobahrie A, Caranasos TG, Vavalle JP, Griffith BE Tags: Med Eng Phys Source Type: research

Unveiling transthyretin cardiac amyloidosis and its predictors among elderly patients with severe aortic stenosis undergoing transcatheter aortic valve replacement
ConclusionsTransthyretin cardiac amyloidosis is prevalent in 16% of patients with severe calcific AS undergoing TAVR and is associated with a severe AS phenotype of low-flow low-gradient with mildly reduced ejection fraction. Average tissue Doppler mitral annular S ’ of <  6 cm/s may be a sensitive measure that should prompt a confirmatory99mTc-PYP scan and subsequent testing for ATTR-CA. Prospective assessment of outcomes after TAVR is needed in patients with and without ATTR-CA.
Source: European Heart Journal - August 1, 2017 Category: Cardiology Source Type: research

Late Results of Cox Maze III Procedure in Patients with Atrial Fibrillation Associated with Structural Heart Disease
Conclusions: The Cox-Maze III procedure, in our experience, is efficacious for sinus rhythm mainte nance, with very low late mortality and stroke rates.Resumo Fundamento: A opera ção de Cox-Maze III é uma das variantes técnicas no tratamento cirúrgico da fibrilação atrial (FA). Objetivos: Estudar os resultados tardios da operação de Cox-Maze III, quanto à eficácia na manutenção de ritmo sinusal e taxas de mortalidade e acidente vascular cerebral (AVC). Método s: Entre janeiro de 2006 a janeiro de 2013, 93 pacientes foram submetidos a operação de Cox-Maze III por corte e sutura associada a correção de card...
Source: Arquivos Brasileiros de Cardiologia - July 31, 2017 Category: Cardiology Source Type: research

Medtronic wins CE Mark for CoreValve Evolut Pro
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its CoreValve Evolut Pro transcatheter aortic heart valve, indicated for the treatment of severe aortic stenosis for symptomatic patients at intermediate, high or extreme risk for open heart surgery The CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said. “We are excited to introduce the next evolution of our Evolut TAVI platform to provide physicians in Europe with a comprehensive portfolio to ...
Source: Mass Device - July 31, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news

Impact of health utility after thrombotic complications following total hip and knee arthroplasty
ConclusionObjective calculation of both the benefit and risks of anticoagulation in the post‐operative patient is significantly altered by including the effect on patient's quality of life utility value. Therapeutic anticoagulation in some common situations is probable to be of more detriment than benefit when considering health utility.
Source: ANZ Journal of Surgery - July 31, 2017 Category: Surgery Authors: Bikram Karmakar Tags: Original Article Source Type: research

Comparison of local versus general anesthesia in patients undergoing transcatheter aortic valve replacement: A meta ‐analysis
ConclusionOur meta‐analysis suggests that use of LA for TAVR is associated with a lower 30‐day mortality, shorter procedure time, fluoroscopy time, ICU LOS, hospital length of stay, and reduced need for inotropic support.
Source: Catheterization and Cardiovascular Interventions - July 24, 2017 Category: Cardiovascular & Thoracic Surgery Authors: Pedro A. Villablanca, Divyanshu Mohananey, Katarina Nikolic, Sripal Bangalore, David P. Slovut, Verghese Mathew, Vinod H. Thourani, Josep Rode's ‐Cabau, Iván J. Núñez‐Gil, Tina Shah, Tanush Gupta, David F. Briceno, Mario J. Garcia, Jacob T Gutsche, Tags: VALVULAR AND STRUCTURAL HEART DISEASES Source Type: research

Surgical Ablation of Atrial Fibrillation in the United States: Trends and Propensity Matched Outcomes
Conclusions Contemporary utilization of SA is increasing across all operative categories. Performance of SA is accompanied by a 30-day reduction in mortality and stroke. These findings further refine our understanding of the role of SA in the treatment of AF.
Source: The Annals of Thoracic Surgery - July 20, 2017 Category: Cardiovascular & Thoracic Surgery Source Type: research

Dual Versus Single Antiplatelet Regimen With or Without Anticoagulation in Transcatheter Aortic Valve Replacement: Indirect Comparison and Meta-analysis
Conclusions The present meta-analysis supports the use of DAPT after TAVR, reducing mortality and offering slight benefits in stroke, with no increase in major bleedings compared with MAPT. The strategy of aspirin + oral anticoagulation did not provide significant benefits compared with MAPT or DAPT.
Source: Revista Espanola de Cardiologia - July 20, 2017 Category: Cardiology Source Type: research

Claret Medical raises $11m
Claret Medical has raised $11.2 million in a new round of equity financing, according to an SEC filing posted this week. Money in the round came from 34 unnamed investors, according to the SEC filing, with the 1st sale dated on June 22. Claret Medical is still looking to raise an additional $6.5 million in the round, according to the SEC filing. The company has not yet stated how it intends to use funds raised in the round. The Santa Rosa, Calif.-based company produces the Sentinel embolic protection device designed to trap blood clots and prevent stroke during heart valve replacement procedures. The Sentinel device uses a...
Source: Mass Device - July 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news

High-pressure balloon fracturing of small dysfunctional Mitroflow bioprostheses facilitates transcatheter aortic valve-in-valve implantation.
CONCLUSIONS: Initial experience with transcatheter BF-VIV suggests that this method is feasible and that it improves aortic valve hemodynamics and clinical functional capacity. BF-VIV is a promising alternative to repeat surgery in patients with small failing bioprostheses. PMID: 28691908 [PubMed - as supplied by publisher]
Source: EuroIntervention - July 12, 2017 Category: Cardiovascular & Thoracic Surgery Tags: EuroIntervention Source Type: research

Clinical and Echocardiographic Outcomes Following Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement: Meta-Analysis and Meta-Regression Structural Heart Disease
Conclusions— PPM implantation is not associated with increased risk of all-cause mortality, cardiovascular mortality, stroke, or myocardial infarction both at short- and long-term follow-up. However, PPM is associated with impaired left ventricular ejection fraction recovery post-transcatheter aortic valve replacement.
Source: Circulation: Cardiovascular Interventions - July 11, 2017 Category: Cardiology Authors: Mohananey, D., Jobanputra, Y., Kumar, A., Krishnaswamy, A., Mick, S., White, J. M., Kapadia, S. R. Tags: Arrhythmias, Valvular Heart Disease, Catheter-Based Coronary and Valvular Interventions, Pacemaker Structural Heart Disease Source Type: research