Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Aortic Stenosis

Waksman, Ron; Rogers, Toby; Torguson, Rebecca; Gordon, Paul; Ehsan, Afshin; Wilson, Sean R.; Goncalves, John; Levitt, Robert G.; Hahn, C; Parikh, Puja B.; Bilfinger, Thomas V.; Butzel, David; Buchanan, Scott; Hanna, Nicholas; Garrett, Robert; Asch, Federico M.; Weissman, Gaby; Ben‐Dor, Itsik; Shults, Christian; Bastian, Roshni; Craig, Paige; García‐García, Héctor M.; Kolm, Paul; Zou, Quan; Satler, Lowell F.; Corso, Paul J.

doi:10.1016/j.jacc.2018.08.1033

Cited by 181 publications

(96 citation statements)

References 17 publications

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“…The incidence of new PPI post-TAVR was 6-10% in PARTNER 1 and PARTNER 2 trials which is similar to 5% seen in low-risk TAVR study [11].…”

Section: Permanent Pacemaker Implantation (Ppi)supporting

confidence: 62%

“…NOTION trial [10] and low-risk TAVR trial [11] evaluated the role of TAVR in low-risk population (STS score <4%).…”

Section: Evolution Of Tavr: Indications and Clinical Trial Evidence Fmentioning

confidence: 99%

“…The overall major vascular complication rate was 17% in PARTNER 1 trial, decreased to 2.5% in low-risk TAVR trial [11], 2018 due to improvements in the sheath and valve delivery systems.…”

Section: Complications Of Tavrmentioning

confidence: 99%

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Transcatheter Aortic Valve Replacement: Clinical Indications and Outcomes

Monigari¹,

Agarwal²

2019

Aortic Stenosis - Current Perspectives

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Severe calcific aortic stenosis (AS) is commonly seen in the elderly population, and as human longevity increases, the prevalence of severe AS is bound to increase. Symptomatic severe AS, if left untreated, carries high mortality with 2-year survival below 50%. Surgical aortic valve replacement (SAVR) had been the standard of care for such patients with excellent outcome. As the patient's comorbidities increase, so does surgical risk for SAVR. Since its first human use in 2002 and commercial approval in 2007 (CE mark, Europe), transcatheter aortic valve replacement (TAVR) has come up as an excellent alternative to SAVR in patients with higher surgical risk profile. Iterations in device design added to enhanced operator experience can be attributed towards improved clinical outcomes. Indications for TAVR continues to expand and now includes patients with intermediate surgical risk as well. This chapter discusses indications and evidence for TAVR and touches upon patient selection and complications after TAVR.

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“…The incidence of new PPI post-TAVR was 6-10% in PARTNER 1 and PARTNER 2 trials which is similar to 5% seen in low-risk TAVR study [11].…”

Section: Permanent Pacemaker Implantation (Ppi)supporting

confidence: 62%

“…NOTION trial [10] and low-risk TAVR trial [11] evaluated the role of TAVR in low-risk population (STS score <4%).…”

Section: Evolution Of Tavr: Indications and Clinical Trial Evidence Fmentioning

confidence: 99%

See 1 more Smart Citation

Transcatheter Aortic Valve Replacement: Clinical Indications and Outcomes

Monigari¹,

Agarwal²

2019

Aortic Stenosis - Current Perspectives

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“…More recently, the results of the Low Risk Trial11 were published. This was a prospective, non-randomised, multicentre trial of low risk patients with severe aortic stenosis undergoing TAVR, and was compared with a historic control of SAVR patients who were propensity matched based on STS score and other comorbidities at the same institutions.…”

Section: Low Surgical Riskmentioning

confidence: 99%

Clinical trials of transcatheter aortic valve replacement

Al‐Azizi

Hamandi

2019

Heart

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Transcatheter aortic valve replacement(TAVR) has emerged as an effective treatment option in patients with severe aortic stenosis, in large part due to a robust evidence base generated by a series of randomised controlled trials (RCTs). During the past decade more than 15 000 patients have been randomised worldwide in nine clinical trials, mostly for regulatory approval in the USA, making it one of the most carefully scrutinised medical devices at the time of introduction into clinical practice. Initial trials were performed in inoperable or extreme risk patients compared to medical therapy and demonstrated superiority. Subsequent RCTs compared TAVR to surgical aortic valve replacement in high and intermediate surgical risk patients and TAVR was found to be non-inferior in all studies. RCTs of low surgical risk patients have completed enrolment and 1 year outcomes will be available in early 2019. The details of the trials, trial results, outcomes and remaining clinical questions are summarised in this article.

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“…A recent prospective, non-randomised, feasibility trial in low-risk patients with symptomatic severe AS compared 200 patients undergoing TAVI with 719 historical controls from the STS database undergoing SAVR 12. At 30 days, there was zero all-cause mortality in the transcatheter aortic valve replacement (TAVR) group versus 1.7% mortality in the SAVR group, and no in-hospital stroke in the TAVR group versus 0.6% stroke in the SAVR group.…”

Section: What Is the Current Evidence For Tavi In Low-risk Patients?mentioning

confidence: 99%

Transcatheter aortic valve implantation in low-risk patients: is it too early?

Sousa-Uva

2019

Heart

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The median age of patients treated by transcatheter aortic valve implantation (TAVI) is falling across Europe, and low-risk patients with severe aortic stenosis (AS) represent 80% of patients with severe AS undergoing surgical aortic valve replacement (SAVR). There are few data for TAVI in low-risk patients, but there are four ongoing randomised trials of SAVR versus TAVI. The key issues relate to pacemaker implantation rates and the associated potential longer term deleterious effects, and the need to minimise vascular complications and paravalvular leak. Valve leaflet thrombosis and paucity of data on valve durability remain a concern. Given the higher incidence of bicuspid aortic valves in younger patients, outcomes of TAVI in this setting need clarification and are discussed.

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Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic Severe Aortic Stenosis

Cited by 181 publications

References 17 publications

Transcatheter Aortic Valve Replacement: Clinical Indications and Outcomes

Transcatheter Aortic Valve Replacement: Clinical Indications and Outcomes

Clinical trials of transcatheter aortic valve replacement

Transcatheter aortic valve implantation in low-risk patients: is it too early?

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