Transcatheter Aortic Valve Replacement: A How-to Guide for Cardiologists and Cardiac Surgeons

By A. Claire Watkins, Anuj Gupta and Bartley P. Griffith

This concise manual describes in detail how to perform a transcatheter aortic valve replacement (TAVR) procedure and provides cardiac surgeons and cardiologists with the foundation necessary to begin practicing TAVR. It includes background on the landmark data establishing the field of TAVR, instructions in the pre- and post-operative management of TAVR patients, and technical descriptions of the newest and most common devices and how to use them. Written by leaders in the field, it offers an unbiased, academic review and describes the experience of colleagues who have learned through trial and error. The Transcatheter Aortic Valve Replacement Manual is an essential resource for physicians and related professionals, residents, fellows, and graduate students in cardiology, cardiac surgery, thoracic surgery, and vascular surgery

• Language: English
• Publisher: Springer
• Release date: Jul 12, 2018
• ISBN: 9783319933962

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© Springer International Publishing AG, part of Springer Nature 2018

A. Claire Watkins, Anuj Gupta and Bartley P. GriffithTranscatheter Aortic Valve Replacementhttps://doi.org/10.1007/978-3-319-93396-2_1

1. Introduction

A. Claire Watkins¹ , Anuj Gupta² and Bartley P. Griffith³

(1)

Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, CA, USA

(2)

Division of Cardiology, University of Maryland, School of Medicine, Baltimore, MD, USA

(3)

Division of Cardiac Surgery, University of Maryland, School of Medicine, Baltimore, MD, USA

Keywords

TAVRTranscatheter aortic valve replacementSevere aortic stenosisValvular diseaseCardiothoracic surgeryAortic valve disease

As the most common valvular disease treated by cardiac surgeons, severe aortic stenosis (AS) carries a significant mortality, with a 50% risk of death over a 2-year period once patients develop significant breathlessness [1]. Since the first transcatheter aortic valve replacement (TAVR) performed in a non-operable patient in 2002 [2], both the study of its clinical use and the development of improved technologies have risen substantially. TAVR therapy is not only an option for 40% of patients considered high risk for surgical aortic valve replacement (SAVR) [3] but is also undergoing investigation for use in low-risk patients. As a cardiothoracic surgeon or interventional cardiologist, it is imperative that you master contemporary TAVR skills in order to offer total care of aortic valve disease. This manual provides the underlying fundamentals of TAVR, including basic information, procedural details, and surgical considerations, to enrich your learning as you scrub on your first or fiftieth TAVR.

References

1.

Otto CM. Timing of aortic valve surgery. Heart. 2000;84:211–8.Crossref

2.

Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006–8.Crossref

3.

Iung B, Cachier A, Baron G, Messika-Zeitoun D, Delahaye F, Tornos P, Gohlke-Bärwolf C, Boersma E, Ravaud P, Vahanian A. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J. 2005 Dec;26(24):2714–20.Crossref

© Springer International Publishing AG, part of Springer Nature 2018

A. Claire Watkins, Anuj Gupta and Bartley P. GriffithTranscatheter Aortic Valve Replacementhttps://doi.org/10.1007/978-3-319-93396-2_2

2. Relevant Clinical Trials

A. Claire Watkins¹ , Anuj Gupta² and Bartley P. Griffith³

(1)

Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, CA, USA

(2)

Division of Cardiology, University of Maryland, School of Medicine, Baltimore, MD, USA

(3)

Division of Cardiac Surgery, University of Maryland, School of Medicine, Baltimore, MD, USA

Keywords

PARTNERsclinical outcomesclinical trialslow-riskTranscatheter Valve Therapy Registry

The PARTNER (Placement of Aortic Transcatheter Valves) trial is a series of trials that included the first prospective, randomized study to demonstrate the safety and non-inferiority of TAVR against medical therapy in inoperable patients and against SAVR in high-risk but operable patients. This consort diagram depicts the design of the study [1], including mortality results (Fig. 2.1):

../images/460774_1_En_2_Chapter/460774_1_En_2_Fig1_HTML.png

Figure 2.1

Design and results of the PARTNER (Placement of Aortic Transcatheter Valves) clinical trial. (JTCVS Volume 143, Issue 4, April 2012, Pages 832–843.e13)

The PARTNER B cohort consisted of 358 patients deemed inoperable by 2 surgeons experienced in high-risk SAVR who were randomized to TAVR or medical therapy. This study was done with the Edwards SAPIEN THV (a first-generation device). Although the Society of Thoracic Surgeons (STS) risk score was not an inclusion criterion for the trial, (the average score was 11.6%), many were inoperable secondary to comorbidities including porcelain aorta, chest radiation, severe COPD, or severe frailty. Both 1- and 2-year data from PARTNER B demonstrated significantly decreased mortality over medical management [2]. At 2 years, mortality in the standard therapy group was 68%, while it was 43% in the TAVR group [3]. Greater than 80% of the medical management group were treated with palliative balloon valvuloplasty, and 10% crossed over to TAVR, neither of which affected the marked survival benefit seen with TAVR. The cohort B patients who demonstrated the greatest survival benefit were those that had a low STS score (<5%) but were inoperable secondary to porcelain aorta, chest radiation, or difficult redo surgery; at 5 years, all strata of patients regardless of STS risk score demonstrated benefit [4]. PARTNER B data revealed a significantly higher stroke rate in TAVR patients at 1 and 2 years, 13.8% in the TAVR group compared to 5.5% standard therapy at 2 years. The PARTNER B trial also demonstrated improvements in NYHA heart failure class and hospitalizations for heart failure compared to medically managed controls. PARTNER B patients demonstrated a significantly improved quality of life with multiple assessment tools [5]. PARTNER B proved TAVR to be the treatment of choice for inoperable patients.

The PARTNER A cohort consisted of 699 patients with STS risk >10% or surgeon assessment of mortality >15%, who were randomized to TAVR or SAVR. The cohort randomized to TAVR received the Edwards SAPIEN THV system. This study validated the non-inferiority of TAVR versus SAVR and allowed transcatheter therapies to be a viable, comparable option in high-risk patients. At 30 days, 1-year and 2-year mortality rates between the TAVR and surgical groups were not significantly different [1], with 33.9% mortality in the TAVR group and 35% in the SAVR group at 2 years [6]. Periprocedural stroke rate in PARTNER A was not significantly different among the two groups at 30 days. At 1 and 2 years, TAVR patients had a higher rate of stroke, 11.2% versus 6.5% in the SAVR patients at 2 years. The study also revealed increased vascular complications among the TAVR patients (11.6% vs 3.8%) and increased major bleeding episodes in the SAVR patients (29.5% vs 19%). Post-procedure renal failure, endocarditis, and new pacemaker placement were similar between the two groups. PARTNER A data illustrated increased post-procedure aortic insufficiency (AI) in the TAVR patients at 1 and 2 years, with 6.9% moderate to severe paravalvular AI in the TAVR group and 0.9% in the SAVR group at 2 years. The study went on to show that at 2 years, even a mild paravalvular leak was associated with increased mortality (HR 2.11) [6].

As the first and longest prospective, randomized clinical trial of TAVR therapy, the 5-year PARTNER A data extended earlier findings. At 5 years, mortality and rate of pacemaker implantation were similar, while TAVR was associated with increased vascular complications [4]. These studies identified both the lifesaving ability of TAVR technology and the common complications and limitations that advanced device development.

In parallel with the development of the SAPIEN system, the Medtronic CoreValve was examined in extreme (equivalent to inoperable in the PARTNER trials) and high-risk patients [7]. The high-risk trial randomized 795 patients to receive Medtronic’s CoreValve or SAVR. Patients were deemed high risk if 2 cardiac surgeons and 1 interventional cardiologist agreed their risk of death or irreversible comorbidity was between 15% and 50% at 30 days. STS risk score was considered but not required for study inclusion. Both transfemoral and alternative access patients were included in the TAVR group prior to randomization. The average STS score of patients in the study was 7.4%. Expanding beyond the non-inferiority of TAVR therapy seen in the PARTNER studies, 1- [8], 2- [9], and 3 [10]-year data from the trial demonstrated a significantly improved survival in TAVR compared with SAVR patients (Fig. 2.2).

../images/460774_1_En_2_Chapter/460774_1_En_2_Fig2_HTML.png

Figure 2.2

Improved results for TAVR compared to SAVR among high-risk patients receiving the CoreValve [10]

Similar to PARTNER, this study found an increase in vascular injury (7% vs 2%) and decrease in life-threatening bleeding (18% vs 40%) among TAVR patients. At 2 years, the CoreValve saw a significant increase in stroke rate among the SAVR patients (11% vs 17%). It also revealed a decreased acute kidney injury (6% vs 15%) and significant pacemaker rate (26% vs 13%) compared to surgical therapy. At 3 years, the rate of mild perivalvular leak with the CoreValve was 51%, and moderate or greater leak was 6.8% (0% in the surgical arm) [10]. This study served to establish transcatheter therapy as the preferred treatment for high-risk severe aortic stenosis and the CoreValve as unique to the balloon-expandable devices with a different outcome profile.

Subsequent to the original PARTNER trial, the PARTNER 2 randomized 2032 intermediate-risk patients, defined as an STS score between 4% and 8%, to the second-generation SAPIEN XT valve compared to SAVR. The primary endpoint of the study, death or disabling stroke, was similar among TAVR and SAVR patients, 19% vs 21%, at 2 years. Additionally, the TAVR group demonstrated increased vascular complications and perivalvular leak but decreased acute kidney injury, new-onset atrial fibrillation, and less severe bleeding when compared to the SAVR patients [11]. When outcomes of transfemoral TAVR and SAVR were compared, TAVR demonstrated a significantly lower rate of death or disabling stroke (HR 0.79). The newer generation SAPIEN 3 valve has also been compared to the SAVR arm of the PARTNER 2 trial in intermediate-risk patients. This observational study demonstrated both improved results with the SAPIEN 3 valve compared to the SAPIEN XT (7.4% mortality, 2% disabling stroke,