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The Mitral Valve
Published in Theo Kofidis, Minimally Invasive Cardiac Surgery, 2021
Besides minimally invasive surgical approaches to the mitral valve, this is an alternative for patients who are medically not suitable for surgery. Transcatheter aortic valve replacement (TAVR) was originally intended for patients who could not undergo surgery, but it has now been established as an excellent alternative to surgical aortic valve replacement in patients at high or intermediate risk. The progress in developments of TAVR with well-designed devices of acceptable safety and efficacy has inspired manufacturers to push the boundaries of innovation to transcatheter mitral valve replacement (TMVR). TMVR is likely to follow a similar path to the one that TAVR has taken, starting with the sickest patients and a narrow indication, but likely attracting less sick patients who would rather have this minimally invasive procedure over surgery.
Causal Inference for Observational Studies/Real-World Data
Published in Harry Yang, Binbing Yu, Real-World Evidence in Drug Development and Evaluation, 2021
In 2017, the FDA moved forward with approving a new indication for a medical device without requiring any new clinical trials. A transcatheter aortic valve replacement (TAVR) is a minimally invasive surgical procedure that repairs the damaged valve without removing it. FDA approved the use of the first TAVR device, the Edwards Sapien transcatheter heart valve (THV), for patients with severe symptoms but are too risky for surgery in 2011. Since then, the device manufacturer had established a product registry with over 100,000 TAVR records. Among these records were 600 records relating to the then off-label use of the new procedure, the Sapien 3. Based on the product registry data, FDA approved use of the new procedure without requiring costly and time-consuming randomized clinical trials. This approval represents a significant milestone in expanded use of RWE in regulatory drug and medical device development (Belson 2018).
Endocarditis
Published in Firza Alexander Gronthoud, Practical Clinical Microbiology and Infectious Diseases, 2020
All three blood cultures flag up with a coagulase-negative Staphylococcus. You start your patient on vancomycin, rifampicin and gentamicin. Because of interactions, you change his warfarin to heparin. Transoesophageal echocardiogram again does not show a vegetation, only the already recognized aortic regurgitation. Subsequently, a cardiac CT is made, which shows a beginning aortic root abscess. The patient undergoes aortic valve replacement and recovers well.
Same Day Discharge during the COVID-19 Pandemic in Highly Selected Transcatheter Aortic Valve Replacement Patients
Published in Structural Heart, 2021
Andrei M. Pop, Madeleine Barker, Lynn Hickman, Firas Barrow, Janarthanan Sathananthan, William Stansfield, Michael Nikolov, Elsayed Mohamed, Sandra Lauck, Jia Wang, John G. Webb, David A. Wood
Transcatheter aortic valve replacement (TAVR) has been established as an alternative to surgical aortic valve replacement in intermediate and high-risk patients.1 Post-TAVR care has shifted to early discharge home with the advent of studies demonstrating the safety and efficacy of a standardized pre-, peri- and post-procedural clinical pathway to facilitate rapid reconditioning, avoidance of in-hospital complications and safe next-day discharge (NDD).2,3 These pathways decreased the need for prolonged critical care monitoring with excellent safety outcomes.2,3 This approach has been successfully implemented across global centers as part of the Edwards Benchmark Program, a mentored team-based quality improvement initiative aimed at facilitating the adoption of best practices across patients’ journey of care from admission to discharge.
Outcomes of surgical versus transcatheter aortic valve replacement in nonagenarians- a systematic review and meta-analysis
Published in Journal of Community Hospital Internal Medicine Perspectives, 2021
Azka Latif, Muhammad Junaid Ahsan, Noman Lateef, Vikas Kapoor, Mohsin Mansoor Mirza, Faiz Anwer, Michael Del Core, Arun Kanmantha Reddy
From 2006–2008, survival among patients older than 85 years has grown steadily in the USA from 720,000 to 1.9 million due to the availability of better healthcare [1]. With improved survival, the prevalence of valvular heart disease is steadily increasing. The most common valvular heart disease encountered in this age group is aortic stenosis with an estimated prevalence of 9.8% [2]. Severe symptomatic aortic stenosis is associated with a worsening of quality of life and functioning [3,4]. Because of the concomitant comorbidities and frailty, this group of patients is considered to be high risk for undergoing surgical aortic valve replacement and is only considered and offered to selective patients. The perioperative risk of mortality associated with surgical aortic valve replacement (SAVR) tends to increase with age up to about 10% in patients aged 85–90 years [5]. Medical therapy often portends a poor prognosis in patients with severe aortic stenosis with patients needing frequent admissions to the hospital with heart failure with progressive decline and eventually death.
Bicuspid aortopathy – molecular involvement of microRNAs and MMP-TIMP
Published in Biomarkers, 2020
Shiho Naito, Johannes Petersen, Tatiana Sequeira-Gross, Niklas Neumann, Jorge Duque Escobar, Tanja Zeller, Hermann Reichenspurner, Evaldas Girdauskas
Our study population included a total of 65 consecutive BAV patients referred to our institution for elective aortic valve surgery with or without concomitant proximal aortic surgery. Demographics and baseline variables of our study group are summarised in Table 1. Briefly, a relatively young, predominantly male cohort with a low perioperative risk was analyzed. Two-thirds of our study population had predominant aortic valve stenosis, while the remaining 23 (34%) patients presented with an isolated aortic regurgitation. 29 (45%) patients had a simultaneous bicuspid aortopathy, defined as a maximal proximal aortic diameter ≥ 40 mm. Two patients had a unicuspid aortic valve disease with predominant aortic stenosis. Aortic valve replacement was performed in 47 (72%) patients, while the remaining 18 (28%) patients underwent aortic valve repair procedure. The concomitant proximal aortic replacement was required in 25 (39%) patients.