Comparison of Outcomes After Transcatheter Aortic Valve Replacement vs Surgical Aortic Valve Replacement Among Patients With Aortic Stenosis at Low Operative Risk

Virtanen, Marko; Eskola, Markku; Jalava, Maina P.; Husso, Annastiina; Laakso, Teemu; Niemelä, Matti; Ahvenvaara, Tuomas; Tauriainen, Tuomas; Maaranen, Pasi; Kinnunen, Esko; Dahlbacka, Sebastian; Jaakkola, Samuli; Vasankari, Tuija; Airaksinen, Juhani; Anttila, Vesa; Rosato, Stefano; D’Errigo, Paola; Savontaus, Mikko; Juvonen, Tatu; Laine, Mika; Mäkikallio, Timo H.; Valtola, Antti; Raivio, Peter; Biancari, Fausto

doi:10.1001/jamanetworkopen.2019.5742

Cited by 33 publications

(33 citation statements)

References 36 publications

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“…Our initial search yielded 1,827 citations, 58 of which were judged to be potentially eligible and underwent full text review. Ten studies were found to be eligible for inclusion after full text review, four RCTs 8,9,18,19 and six PSM studies [20][21][22][23][24][25] . There were two studies from the OBSERVANT registry 20,23 , of which only the study by Rosato et al 23 intentionally included only low surgical risk patients, while the study by Fraccaro et al 20 was limited to patients older than 80 and intended to include also intermediate-risk patients.…”

Section: Resultsmentioning

confidence: 99%

“…AVA: aortic valve area; AVG: aortic valve gradient; CKD: chronic kidney disease; CVA: cerebrovascular accident; DM: diabetes mellitus; EF: ejection fraction; NA: not available; NYHA: New York Heart Association; PVD: peripheral vascular disease *the patient characteristics are reported for a PSM cohort of 405 matched pairs, the mortality data included in this meta-analysis are derived from 191 matched pairs of patients with STS score <4%. $ definitions of CKD in each study: [8] Creatinine >2 mg/dL, [9] Creatinine >2 mg/dL, [18] Creatinine >200 mmol/L, [19] Creatinine >2 mg/dL, [23] Creatinine >1.2 mg/dL, [24] Creatinine >200 mmol/L, [25] eGFR <30 mL/min/1.73 m 2 .…”

Section: Impact On Daily Practicementioning

confidence: 99%

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Meta-analysis of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients at low surgical risk

Witberg¹,

Landes²,

Lador³

et al. 2019

EuroIntervention

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Aims: Although transcatheter aortic valve implantation (TAVI) is officially indicated for severe aortic stenosis (AS) patients at intermediate or higher surgical risk, the procedure is now increasingly being performed in patients who are at low surgical risk. Data on the benefit of TAVI in this patient population are limited. We therefore aimed to perform an updated meta-analysis of all published randomised controlled trials (RCTs) and propensity score-matched studies comparing TAVI versus surgical aortic valve replacement (SAVR) in patients at low surgical risk. Methods and results:We conducted a systematic review and meta-analysis of RCTs and observational studies with propensity score matching (PSM) of TAVI versus SAVR in patients who are at low surgical risk (mean STS score <4% and/or logistic EuroSCORE <10%). The primary outcome was mortality (examined at 30 days, one year and the longest available follow-up). The secondary outcomes included procedural complications. Nine studies (n=6,124) were included. TAVI was associated with a numerically, but not statistically, significant reduced mortality at 30 days (1.45% vs 2.1%, p=0.05), and similar mortality at one year (5.1% vs 5.0%, p=0.74) and a median of two years (10.8% vs 9.8%, p=0.15). For both time points, there was significant heterogeneity between RCT/PSM studies, with the former suggesting survival advantage for TAVI and the latter for SAVR. In terms of periprocedural complications, TAVI was associated with reduced risk for stroke, bleeding and renal failure and an increase in vascular complications and pacemaker implantation. Conclusions:In patients who are at low surgical risk, TAVI seems to be associated with equivalent mortality up to a median follow-up of two years compared to SAVR. More data are required before TAVI can be routinely considered as an alternative to SAVR in low-risk patients.

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Section: Resultsmentioning

confidence: 99%

Section: Impact On Daily Practicementioning

confidence: 99%

Meta-analysis of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients at low surgical risk

Witberg¹,

Landes²,

Lador³

et al. 2019

EuroIntervention

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“…The indications for TAVR are expanding, but it is controversial whether TAVR should be performed on a larger scale because of limited data on the long-term outcome and valve durability of TAVR prostheses compared to SAVR prostheses. Similar longer-term survival after TAVR and SAVR is observed in randomized controlled trials [1,6,7], but studies reporting outcomes in the realworld populations have discordant findings [9][10][11][12]. Sustained valve hemodynamics and low reintervention rate is associated with the use of first-generation balloon-expandable Sapien bioprosthesis [1,13].…”

Section: Introductionmentioning

confidence: 86%

Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis

Virtanen

Eskola

Savontaus

et al. 2020

J Cardiothorac Surg

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Background: There is limited information on the longer-term outcome after transcatheter aortic valve replacement (TAVR) with new-generation prostheses compared to surgical aortic valve replacement (SAVR). The aim of this study was to compare the mid-term outcomes after TAVR with Sapien 3 and SAVR with Perimount Magna Ease bioprostheses for severe aortic stenosis. Methods: In a retrospective study, we included patients who underwent transfemoral TAVR with Sapien 3 or SAVR with Perimount Magna Ease bioprosthesis between January 2008 and October 2017 from the nationwide FinnValve registry. Propensity score matching was performed to adjust for differences in the baseline characteristics. The Kaplan-Meir method was used to estimate late mortality. Results: A total of 2000 patients were included (689 in the TAVR cohort and 1311 in the SAVR cohort). Propensity score matching resulted in 308 pairs (STS score, TAVR 3.5 ± 2.2% vs. SAVR 3.5 ± 2.8%, p = 0.918). In-hospital mortality was 3.6% after SAVR and 1.3% after TAVR (p = 0.092). Stroke, acute kidney injury, bleeding and atrial fibrillation were significantly more frequent after SAVR, but higher rate of vascular complications was observed after TAVR. The cumulative incidence of permanent pacemaker implantation at 4 years was 13.9% in the TAVR group and 6.9% in the SAVR group (p = 0.0004). At 4-years, all-cause mortality was 20.6% for SAVR and 25.9% for TAVR (p = 0.910). Fouryear rates of coronary revascularization, prosthetic valve endocarditis and repeat aortic valve intervention were similar between matched cohorts. Conclusions: The Sapien 3 bioprosthesis achieves comparable midterm outcomes to a surgical bioprosthesis with proven durability such as the Perimount Magna Ease. However, the Sapien 3 bioprosthesis was associated with better early outcome. Trial registration: ClinicalTrials.gov Identifier: NCT03385915.

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“…11 A retrospective comparative effectiveness cohort study of the Nationwide Finnish Registry revealed no significant difference in mortality outcomes between low-operativerisk patients who underwent TAVR with third generation devices and propensity scoreÀmatched pairs. 12 Lastly, it is possible that the surgeons involved in the treatment centers were simply superior technically and perioperative care was exceptional. The authors also noted the E-AVR registry was designed to look at outcomes among 6 countries (France, Germany, Italy, Spain, Switzerland, and the United Kingdom), but the data cited in this article were only from 3 countries (France, Italy, and Spain) without acknowledgment as to why that was the case.…”

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confidence: 99%

TAVR Versus SAVR for the Treatment of Aortic Stenosis: Do We Have a Clear Winner?

Nampi

Pospishil

Neuburger

2020

Journal of Cardiothoracic and Vascular Anesthesia

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Comparison of Outcomes After Transcatheter Aortic Valve Replacement vs Surgical Aortic Valve Replacement Among Patients With Aortic Stenosis at Low Operative Risk

Abstract: This comparative effectiveness cohort study examines 30-day and 3-year survival among Finnish patients with aortic stenosis at low operative risk who underwent transcatheter aortic valve replacement compared with surgical aortic valve replacement.

Cited by 33 publications

References 36 publications

Meta-analysis of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients at low surgical risk

Meta-analysis of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients at low surgical risk

Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis

TAVR Versus SAVR for the Treatment of Aortic Stenosis: Do We Have a Clear Winner?

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