Updated clinical indications for transcatheter aortic valve implantation in patients with severe aortic stenosis: expert opinion of the Italian Society of Cardiology and GISE

Ciro Indolfi, Antonio L Bartorelli, Sergio Berti, Paolo Golino, Giovanni Esposito, Giuseppe Musumeci, Sonia Petronio, Corrado Tamburino, Giuseppe Tarantini, Gianpaolo Ussia, Corrado Vassanelli, Carmen Spaccarotella, Roberto Violini, Giuseppe Mercuro, Francesco Romeo

Research output: Contribution to journalReview article

Abstract

: The introduction of percutaneous treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) remains one of the greatest achievements of interventional cardiology. In fact, TAVI emerged as a better option than either medical therapy or balloon aortic valvuloplasty for patients who cannot undergo surgical aortic valve replacement (SAVR) or are at high surgical risk. Recently, increased operator experience and improved device systems have led to a worldwide trend toward the extension of TAVI to low-risk or intermediate-risk patients. In this expert opinion paper, we first discuss the basic pathophysiology of aortic stenosis in different settings then the key results of recent clinical investigations on TAVI in intermediate-risk aortic stenosis patients are summarized. Particular emphasis is placed on the results of the nordic aortic valve intervention, placement of aortic transcatheter valves (PARTNER) 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Randomized trials. The PARTNER 2 was the first large randomized trial that evaluated the outcome of TAVI in patients at intermediate risk. The PARTNER 2 data demonstrated that TAVI is a feasible and reasonable alternative to surgery in intermediate-risk patients (Society of Thoracic Surgeons 4-8%), especially if they are elderly or frail. There was a significant interaction between TAVI approach and mortality, with transfemoral TAVI showing superiority over SAVR. Moreover, we examine the complementary results of the recently concluded Surgical Replacement and Transcatheter Aortic Valve Implantation trial. This prospective randomized trial demonstrated that TAVI is comparable with surgery (primary end point 12.6% in the TAVI group vs. 14.0% in the SAVR group) in severe aortic stenosis patients deemed to be at intermediate risk. We review the most relevant clinical evidence deriving from nonrandomized studies and meta-analyses. Altogether, clinical outcome available data suggest that TAVI with a newer generation device might be the preferred treatment option in this patient subgroup. Finally, the differences between the latest European and American Guidelines on TAVI were reported and discussed. The conclusion of this expert opinion article is that TAVI, if feasible, is the treatment of choice in patients with prohibitive or high surgical risk and may lead to similar or lower early and midterm mortality rates compared with SAVR in intermediate-risk patients with severe aortic stenosis.

Original languageEnglish
Pages (from-to)197-210
Number of pages14
JournalJournal of cardiovascular medicine (Hagerstown, Md.)
Volume19
Issue number5
DOIs
Publication statusPublished - May 2018

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Aortic Valve Stenosis
Expert Testimony
Cardiology
Aortic Valve
Surgical Instruments
Transcatheter Aortic Valve Replacement
Balloon Valvuloplasty
Frail Elderly
Equipment and Supplies
Mortality
Therapeutics
Meta-Analysis

Keywords

  • Aortic Valve/surgery
  • Aortic Valve Stenosis/surgery
  • Cardiology
  • Heart Valve Prosthesis/adverse effects
  • Humans
  • Italy
  • Postoperative Complications/epidemiology
  • Practice Guidelines as Topic
  • Randomized Controlled Trials as Topic
  • Societies, Medical
  • Transcatheter Aortic Valve Replacement/adverse effects

Cite this

Updated clinical indications for transcatheter aortic valve implantation in patients with severe aortic stenosis : expert opinion of the Italian Society of Cardiology and GISE. / Indolfi, Ciro; Bartorelli, Antonio L; Berti, Sergio; Golino, Paolo; Esposito, Giovanni; Musumeci, Giuseppe; Petronio, Sonia; Tamburino, Corrado; Tarantini, Giuseppe; Ussia, Gianpaolo; Vassanelli, Corrado; Spaccarotella, Carmen; Violini, Roberto; Mercuro, Giuseppe; Romeo, Francesco.

In: Journal of cardiovascular medicine (Hagerstown, Md.), Vol. 19, No. 5, 05.2018, p. 197-210.

Research output: Contribution to journalReview article

Indolfi, C, Bartorelli, AL, Berti, S, Golino, P, Esposito, G, Musumeci, G, Petronio, S, Tamburino, C, Tarantini, G, Ussia, G, Vassanelli, C, Spaccarotella, C, Violini, R, Mercuro, G & Romeo, F 2018, 'Updated clinical indications for transcatheter aortic valve implantation in patients with severe aortic stenosis: expert opinion of the Italian Society of Cardiology and GISE', Journal of cardiovascular medicine (Hagerstown, Md.), vol. 19, no. 5, pp. 197-210. https://doi.org/10.2459/JCM.0000000000000636
Indolfi, Ciro ; Bartorelli, Antonio L ; Berti, Sergio ; Golino, Paolo ; Esposito, Giovanni ; Musumeci, Giuseppe ; Petronio, Sonia ; Tamburino, Corrado ; Tarantini, Giuseppe ; Ussia, Gianpaolo ; Vassanelli, Corrado ; Spaccarotella, Carmen ; Violini, Roberto ; Mercuro, Giuseppe ; Romeo, Francesco. / Updated clinical indications for transcatheter aortic valve implantation in patients with severe aortic stenosis : expert opinion of the Italian Society of Cardiology and GISE. In: Journal of cardiovascular medicine (Hagerstown, Md.). 2018 ; Vol. 19, No. 5. pp. 197-210.
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abstract = ": The introduction of percutaneous treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) remains one of the greatest achievements of interventional cardiology. In fact, TAVI emerged as a better option than either medical therapy or balloon aortic valvuloplasty for patients who cannot undergo surgical aortic valve replacement (SAVR) or are at high surgical risk. Recently, increased operator experience and improved device systems have led to a worldwide trend toward the extension of TAVI to low-risk or intermediate-risk patients. In this expert opinion paper, we first discuss the basic pathophysiology of aortic stenosis in different settings then the key results of recent clinical investigations on TAVI in intermediate-risk aortic stenosis patients are summarized. Particular emphasis is placed on the results of the nordic aortic valve intervention, placement of aortic transcatheter valves (PARTNER) 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Randomized trials. The PARTNER 2 was the first large randomized trial that evaluated the outcome of TAVI in patients at intermediate risk. The PARTNER 2 data demonstrated that TAVI is a feasible and reasonable alternative to surgery in intermediate-risk patients (Society of Thoracic Surgeons 4-8{\%}), especially if they are elderly or frail. There was a significant interaction between TAVI approach and mortality, with transfemoral TAVI showing superiority over SAVR. Moreover, we examine the complementary results of the recently concluded Surgical Replacement and Transcatheter Aortic Valve Implantation trial. This prospective randomized trial demonstrated that TAVI is comparable with surgery (primary end point 12.6{\%} in the TAVI group vs. 14.0{\%} in the SAVR group) in severe aortic stenosis patients deemed to be at intermediate risk. We review the most relevant clinical evidence deriving from nonrandomized studies and meta-analyses. Altogether, clinical outcome available data suggest that TAVI with a newer generation device might be the preferred treatment option in this patient subgroup. Finally, the differences between the latest European and American Guidelines on TAVI were reported and discussed. The conclusion of this expert opinion article is that TAVI, if feasible, is the treatment of choice in patients with prohibitive or high surgical risk and may lead to similar or lower early and midterm mortality rates compared with SAVR in intermediate-risk patients with severe aortic stenosis.",
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T1 - Updated clinical indications for transcatheter aortic valve implantation in patients with severe aortic stenosis

T2 - expert opinion of the Italian Society of Cardiology and GISE

AU - Indolfi, Ciro

AU - Bartorelli, Antonio L

AU - Berti, Sergio

AU - Golino, Paolo

AU - Esposito, Giovanni

AU - Musumeci, Giuseppe

AU - Petronio, Sonia

AU - Tamburino, Corrado

AU - Tarantini, Giuseppe

AU - Ussia, Gianpaolo

AU - Vassanelli, Corrado

AU - Spaccarotella, Carmen

AU - Violini, Roberto

AU - Mercuro, Giuseppe

AU - Romeo, Francesco

PY - 2018/5

Y1 - 2018/5

N2 - : The introduction of percutaneous treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) remains one of the greatest achievements of interventional cardiology. In fact, TAVI emerged as a better option than either medical therapy or balloon aortic valvuloplasty for patients who cannot undergo surgical aortic valve replacement (SAVR) or are at high surgical risk. Recently, increased operator experience and improved device systems have led to a worldwide trend toward the extension of TAVI to low-risk or intermediate-risk patients. In this expert opinion paper, we first discuss the basic pathophysiology of aortic stenosis in different settings then the key results of recent clinical investigations on TAVI in intermediate-risk aortic stenosis patients are summarized. Particular emphasis is placed on the results of the nordic aortic valve intervention, placement of aortic transcatheter valves (PARTNER) 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Randomized trials. The PARTNER 2 was the first large randomized trial that evaluated the outcome of TAVI in patients at intermediate risk. The PARTNER 2 data demonstrated that TAVI is a feasible and reasonable alternative to surgery in intermediate-risk patients (Society of Thoracic Surgeons 4-8%), especially if they are elderly or frail. There was a significant interaction between TAVI approach and mortality, with transfemoral TAVI showing superiority over SAVR. Moreover, we examine the complementary results of the recently concluded Surgical Replacement and Transcatheter Aortic Valve Implantation trial. This prospective randomized trial demonstrated that TAVI is comparable with surgery (primary end point 12.6% in the TAVI group vs. 14.0% in the SAVR group) in severe aortic stenosis patients deemed to be at intermediate risk. We review the most relevant clinical evidence deriving from nonrandomized studies and meta-analyses. Altogether, clinical outcome available data suggest that TAVI with a newer generation device might be the preferred treatment option in this patient subgroup. Finally, the differences between the latest European and American Guidelines on TAVI were reported and discussed. The conclusion of this expert opinion article is that TAVI, if feasible, is the treatment of choice in patients with prohibitive or high surgical risk and may lead to similar or lower early and midterm mortality rates compared with SAVR in intermediate-risk patients with severe aortic stenosis.

AB - : The introduction of percutaneous treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) remains one of the greatest achievements of interventional cardiology. In fact, TAVI emerged as a better option than either medical therapy or balloon aortic valvuloplasty for patients who cannot undergo surgical aortic valve replacement (SAVR) or are at high surgical risk. Recently, increased operator experience and improved device systems have led to a worldwide trend toward the extension of TAVI to low-risk or intermediate-risk patients. In this expert opinion paper, we first discuss the basic pathophysiology of aortic stenosis in different settings then the key results of recent clinical investigations on TAVI in intermediate-risk aortic stenosis patients are summarized. Particular emphasis is placed on the results of the nordic aortic valve intervention, placement of aortic transcatheter valves (PARTNER) 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Randomized trials. The PARTNER 2 was the first large randomized trial that evaluated the outcome of TAVI in patients at intermediate risk. The PARTNER 2 data demonstrated that TAVI is a feasible and reasonable alternative to surgery in intermediate-risk patients (Society of Thoracic Surgeons 4-8%), especially if they are elderly or frail. There was a significant interaction between TAVI approach and mortality, with transfemoral TAVI showing superiority over SAVR. Moreover, we examine the complementary results of the recently concluded Surgical Replacement and Transcatheter Aortic Valve Implantation trial. This prospective randomized trial demonstrated that TAVI is comparable with surgery (primary end point 12.6% in the TAVI group vs. 14.0% in the SAVR group) in severe aortic stenosis patients deemed to be at intermediate risk. We review the most relevant clinical evidence deriving from nonrandomized studies and meta-analyses. Altogether, clinical outcome available data suggest that TAVI with a newer generation device might be the preferred treatment option in this patient subgroup. Finally, the differences between the latest European and American Guidelines on TAVI were reported and discussed. The conclusion of this expert opinion article is that TAVI, if feasible, is the treatment of choice in patients with prohibitive or high surgical risk and may lead to similar or lower early and midterm mortality rates compared with SAVR in intermediate-risk patients with severe aortic stenosis.

KW - Aortic Valve/surgery

KW - Aortic Valve Stenosis/surgery

KW - Cardiology

KW - Heart Valve Prosthesis/adverse effects

KW - Humans

KW - Italy

KW - Postoperative Complications/epidemiology

KW - Practice Guidelines as Topic

KW - Randomized Controlled Trials as Topic

KW - Societies, Medical

KW - Transcatheter Aortic Valve Replacement/adverse effects

U2 - 10.2459/JCM.0000000000000636

DO - 10.2459/JCM.0000000000000636

M3 - Review article

C2 - 29578921

VL - 19

SP - 197

EP - 210

JO - Journal of Cardiovascular Medicine

JF - Journal of Cardiovascular Medicine

SN - 1558-2027

IS - 5

ER -