5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients

Gleason, Thomas G.; Reardon, Michael J.; Popma, Jeffrey J.; Deeb, G. Michael; Yakubov, Steven J.; Lee, Joon S.; Kleiman, Neal S.; Chetcuti, Stan; Hermiller, James; Heiser, John; Merhi, William; Zorn, George L.; Tadros, Peter; Robinson, N. Bryce; Petrossian, George; Hughes, G. Chad; Harrison, J. Kevin; Conte, John V.; Mumtaz, Mubashir; Oh, Jae K.; Huang, Jian; Adams, David H.

doi:10.1016/j.jacc.2018.08.2146

Cited by 320 publications

(206 citation statements)

References 22 publications

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“…Following on from the work of the PARTNER trials, the CoreValve US pivotal high‐risk trial was the first randomized control trial to demonstrate superior 1‐year mortality rates in high‐risk TAVI patients when compared when high‐risk SAVR patients . The 5‐year outcomes from this randomized control trial published this year also support the 5‐year outcome generated from the PARTNER 1A trial, highlighting the safety and efficacy of the application of TAVI for midterm results …”

Section: Tavi In High‐risk Patientsmentioning

confidence: 63%

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TAVI and the future of aortic valve replacement

et al. 2019

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Aortic valve stenosis (AS) is the most common valvular pathology and has traditionally been managed using surgical aortic valve replacement (SAVR). A large proportion of affected patient demographics, however, are unfit to undergo major surgery given underlying comorbidities. Since its introduction in 2002, transcatheter aortic valve implantation (TAVI) has gained popularity and transformed the care available to different-risk group patients with severe symptomatic AS. Specific qualifying criteria and refinement of TAVI techniques are fundamental in determining successful outcomes for intervention. Given the successful applicability in high-risk patients, TAVI has been further developed and trialed in intermediate and low-risk patients. Within intermediate-risk patient groups, TAVI was shown to be noninferior to SAVR evaluating 30-d mortality and secondary endpoints such as the risk of bleeding, development of acute kidney injury, and length of admission. The feasibility of expanding TAVI procedures into low-risk patients is still a controversial topic in the literature. A number of trials have recently been published which demonstrate TAVI as noninferior and even superior over SAVR for primary study endpoints. K E Y W O R D S aortic valve, surgery, TAVI, valve replacement 1 | INTRODUCTION Aortic valve stenosis (AS) is the most common valvular pathology, with between 2% and 4% of patients over the age of 75 years bring affected. 1 For decades, surgical aortic valve replacement (SAVR) has been considered the class I recommendation in the management of AS. 2 However, given that advanced age, frailty, and significant comorbidities are increasingly prevalent in affected patients; more than one-third of high-risk and severe symptomatic AS patients were not considered physiologically fit enough for major surgical intervention. 2,3 This merited the development of TAVI, an intervention suitable for high-risk patients and those deemed unfit for surgery. With a shift in clinical paradigm toward minimally invasive procedures, the development of TAVI has revolutionized clinical outcomes in AS, particularly in those once considered inoperable. 4 The decision to use TAVI vs SAVR for aortic valve replacement (AVR) is determined by clinical, anatomical, and technical considerations. Since its introduction in 2002, 5 TAVI has increasingly replaced SAVR, the once considered gold standard treatment, in aortic valve diseases. 6-10 More recently, trials such as the Placement of Aortic Trans-Catheter Valve II (PARTNER II) and Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) 11,12 have further established the use of TAVI in intermediate-risk patients as well. Given this validation of TAVI within high-and intermediate-risk patients, a need has now developed to evaluate the clinical efficacy of TAVI within low-risk surgical candidates. 13Selective candidate criteria, as well as advances in operative techniques within TAVI, are mainstay contributors to successful outcomes. Fundamentally, there exist both retrogr...

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Section: Tavi In High‐risk Patientsmentioning

confidence: 63%

“…The commonplace use of TAVI in high‐risk patients with severe aortic stenosis is now widespread and has been shown in recent years to perform similarly to surgical aortic valve repair . TAVI and SAVR now actually share the same guideline recommendations for high‐risk patients with aortic stenosis .…”

Section: Tavi In High‐risk Patientsmentioning

confidence: 99%

TAVI and the future of aortic valve replacement

et al. 2019

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“…Bioprosthetic aortic valve is an implanted device made of non‐synthetic origin to replace severe dysfunctional aortic valve during SAVR or TAVR. Recently, reports have shown that TAVR is suitable not only for surgical‐prohibitive or high‐risk patients, but also for intermediate and low‐risk patients, and therefore, the number of patients undergoing TAVR is expected to be up to 270 000 in Northern‐America and Europe annually . Bioprosthetic aortic valve replacement (bAVR) during TAVR is fast becoming a key treatment for relieving symptomatic severe aortic valve stenosis.…”

Section: Introductionmentioning

confidence: 99%

Impact of leaflet thrombosis on hemodynamics and clinical outcomes after bioprosthetic aortic valve replacement: A meta‐analysis

Tian

2020

Clinical Cardiology

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Background: Leaflet thrombosis (LT, also called cusp thrombosis) detected by multidetector computed tomography (MDCT) is common in bioprosthetic aortic valve replacement (bAVR). However, it remains contradictory whether MDCT-defined LT following bAVR is associated with hemodynamic deterioration and stroke. Thus, we performed the first meta-analysis to assess hemodynamic outcomes and updated the latest researches on the clinical outcomes of MDCT-defined LT after bAVR. Hypothesis: MDCT-defined LT might be associated with worse hemodynamic and clinical outcomes after bAVR. Method: MEDLINE, EMBASE, Cochrane Library, and ClinicalTrial.gov were searched from inception to 15th April 2019. The fix-effect model was utilized to calculate odds ratio (OR) and 95% confidence interval (CI). The primary outcomes were hemodynamic stability indexes, including mean pressure gradient (MPG), left ventricular ejection fraction (LVEF), paravalvular leak (PVL), and clinical heart failure. The secondary endpoints were major adverse cardiovascular and cerebrovascular events (MACCEs), which consisted of myocardial infarction, all-cause death, stroke, and transient ischemic attack (TIA).Results: Twelve studies with 4820 patients were included. The total prevalence of MDCT-defined LT was 9.7%. MDCT-defined LT was associated with a significantly increased risk of MPG (inverse variance 0.43, 95% CI: [0.30, 0.57]), MACCEs (OR 2.43, 95% CI: [1.45, 4.06]), stroke (OR 1.79, 95% CI: [1.03, 3.11]), and TIA (OR 4.09, 95% CI: [1.59, 10.54]). There were no differences for other outcomes.Conclusions: MDCT-defined LT after bAVR is associated with increased MPG and increased risk of adverse cerebrovascular events, including TIA and stroke. While LVEF, PVL, and clinical heart failure were similar between patient with and without LT. K E Y W O R D S aortic stenosis, bioprosthetic aortic valve, surgical aortic valve replacement, thrombosis, transcatheter aortic valve replacement

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“…Transcatheter aortic valve replacement (TAVR) for symptomatic aortic valve stenosis is now standard practice, with transfemoral (TF) access offering procedural safety and outcomes equivalent or superior to surgical aortic valve replacement (SAVR). [1][2][3][4][5] Influenced by European experience, cost savings and proven safety, United States (US) heart teams have migrated towards performing TAVR using a minimalist approach, with local anesthesia and procedural sedation. [6][7][8] For heart teams performing minimalist approach cases, there are many programmatic variations in emergency surgical bailout readiness and preparedness.…”

Section: Introductionmentioning

confidence: 99%

Intrathoracic complications associated with trans‐femoral transcatheter aortic valve replacement: Implications for emergency surgical preparedness

Hodson

Jin

Ring

et al. 2019

Cathet Cardio Intervent

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Background Intrathoracic complications (ITC) requiring emergency surgical intervention occur during transcatheter aortic valve replacement (TAVR). Objectives Characterize the incidence, outcomes and predictors of ITC in a large cohort of transfemoral (TF) TAVR cases over a 5 year period. Methods Retrospective registry and chart review of all nonclinical trial TF‐TAVR patients from seven centers within one hospital system from 2012–2016. ITC were defined as cardiac perforation, new or worsening pericardial effusion/tamponade, annular rupture, thoracic aortic injury, aortic valve dislodgement, and coronary artery occlusion. Procedural and 30‐day outcomes and 1‐year mortality were compared between ITC and no ITC patients. Multivariable logistic regression was used to identify predictors of ITC. Results Over the study period, 1,581 patients had TF‐TAVR and 68 ITC occurred in 46 patients (2.9%). The most common ITCs were pericardial effusion/tamponade (59%), cardiac perforation (33%), and valve dislodgement (33%). ITC rate did not decline over time (rate (95% confidence interval) for 2012 = 0% (0–8.8%), 2013 = 1.3% (0–7.2%), 2014 = 4.4% (2.2–8.0%), 2015 = 3.5% (2.0–5.6%), and 2016 = 2.4% (1.5–3.8%)). ITC patients had worse 1‐year survival (ITC: 60.7% (45.1–73.1%), no ITC: 88.7% (87.0–90.3%); p < .001). The majority of ITC patient deaths occurred within the first 30 days. Multivariable models to predict ITC were not successful. Conclusions ITC did not decline over time in our cohort. Predictors of ITC could not be identified. While these events are rare, they are associated with worse procedural outcomes and mortality. Heart teams should continue to be prepared for emergency intervention.

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5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients

Cited by 320 publications

References 22 publications

TAVI and the future of aortic valve replacement

TAVI and the future of aortic valve replacement

Impact of leaflet thrombosis on hemodynamics and clinical outcomes after bioprosthetic aortic valve replacement: A meta‐analysis

Intrathoracic complications associated with trans‐femoral transcatheter aortic valve replacement: Implications for emergency surgical preparedness

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