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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).
Indications for Permanent Pacing and Cardiac Resynchronization Therapy
Published in Andrea Natale, Oussama M. Wazni, Kalyanam Shivkumar, Francis E. Marchlinski, Handbook of Cardiac Electrophysiology, 2020
Shiv Bagga, J. David Burkhardt, Mandeep Bhargava
In recent years, TAVR has become a well-accepted option for treating patients with aortic stenosis at intermediate to high surgical risk.53 However, conduction disturbances, mainly new-onset LBBB and advanced AV block requiring permanent pacemaker implantation, remain the most common complication of this procedure. Conduction disturbances in the setting of TAVR, result primarily from a direct mechanical insult to the conduction system as well as association between aortic stenosis and conduction disturbances due to calcium deposition on the conduction system because of its proximity to the aortic valve complex.54,55 In addition, inter-individual variability of the antero-posterior relationship of the AV node with respect to the apex of the triangle of Koch, as well as the length of the non-penetrating portion of the His bundle predisposes patients to a higher risk of TAVR-induced conduction disturbances.56 The main risk factors of conduction disturbances include the presence of baseline RBBB, the use of some self-expanding valve systems, and the depth of prosthesis implantation within the left ventricular outflow tract.57–59
A systematic review on durability and structural valve deterioration in TAVR and surgical AVR
Published in Acta Cardiologica, 2021
Sercan Okutucu, Attaullah Khan Niazi, Dinaldo Oliveira, Sefik Gorkem Fatihoglu, Ali Oto
Recent data from several randomised studies and registries showed a very low rate of valve deterioration after TAVR up to 5 years. The PARTNER 1 (Placement of Aortic Transcatheter Valves) trial demonstrated no evidence of SVD at 5 years of follow-up for both surgical and balloon expandable transcatheter prostheses [16]. Toggweiler et al. [54] reported favourable 5-year outcomes after balloon-expandable valve, with signs of moderate SVD in 3.4% of patients and no cases of severe prosthetic regurgitation or stenosis. Long-term data on self-expandable THVs are revealed by the CoreValve ADVANCE study (CoreValve Advance International Post Market Study) which reported SVD in 0.2% of patients at 1 year and 0.9% at 5 years according to VARC-2 criteria [55]. Recently the FRANCE-2 registry, with 459 patients having an echocardiographic evaluation, demonstrated good durability for both types of THVs with 2.5% severe SVD in cumulative incidence function at 5 years according to the recent EAPCI definition [56].
TAVR and Dialysis Are a Challenging Combination. A Case Report and Systematic Review of Literature
Published in Structural Heart, 2021
Alessandro Iadanza, Alessandro Antenore, Antonio Biancofiore, Francesco Contorni, Giulia Biagioni, Cristiana Bellan, Giuseppe Davoli, Massimo Fineschi
Hirji et al26 analyzed the Medicare Provider profile to include all US patients undergoing TAVR from 2012 to 2017. The incidence of surgical explantation was 0.2% (227 of 132,633 patients), and was 0.28% and 0.14% in the early and newer TAVR era, respectively. The median time to surgical explantation was 212 days, whereas 8.8% and 70.9% underwent surgical explantation within 30 days and 1 year, respectively. The primary indication for reintervention was bioprosthetic failure (79.3%). The 30-day and 1-year mortality rates were 13.2% and 22.9%, respectively, and did not vary by either time to surgical explant or TAVR era, or between patients with versus without endocarditis (P > 0.05). Although the overall incidence was low, short-term mortality was high. These findings stress the importance of future mechanistic studies on TAVR explantation and may have implications on lifetime management of aortic stenosis, particularly in younger patients.
Aortic valve stenosis and cancer: a common and complex association
Published in Expert Review of Cardiovascular Therapy, 2021
Silvia Frattini, Giovanni Troise, Carlo Fucci, Gregg S Pressman, Pompilio Faggiano
TAVR has been rapidly established as the treatment choice for symptomatic patients with severe AS who have intermediate or high surgical risk as assessed by the heart team because it is less invasive than SAVR. However, major comorbidities may influence post-TAVR prognosis just as with SAVR [94]. The benefit of TAVR may be limited among patients with short life expectancy due to noncardiac conditions. Thus, patients with an estimated life expectancy <2 years due to malignancies were excluded from major TAVR trials. As cancer treatment improves, some patients with severe AS and malignancy, including advanced metastatic diseases, may be more threatened by the poor prognosis of valvular disease (if left untreated) than by the cancer [95]. It should be taken into consideration that cancer patients with AS may need a valve intervention in different stages of their neoplastic disease. Patients with remitted cancers are often eligible for TAVR [96]: remission should be evaluated and confirmed by the oncology team before referring the patient to the catheterization lab.