Clinical and procedural outcomes with the SAPIEN 3 versus the SAPIEN XT prosthetic valves in transcatheter aortic valve replacement: A systematic review and meta-analysis
Ramyashree Tummala MD
Department of Internal Medicine, St. Vincent Charity Medical Center, An Affiliate of Case Western Reserve University, Cleveland, Ohio
N.B. Ramyashree Tummala and Kinjal Banerjee are equal contributors to this manuscript.
Search for more papers by this authorKinjal Banerjee MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
N.B. Ramyashree Tummala and Kinjal Banerjee are equal contributors to this manuscript.
Search for more papers by this authorKesavan Sankaramangalam MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorStephanie Mick MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorAmar Krishnaswamy MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorJonathon White MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorMaan Fares MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorAnand Mehta MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorZoran Popovic MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorLars G. Svensson MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorCorresponding Author
Samir R. Kapadia MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Correspondence Samir Kapadia, MD, Professor of Medicine, Director, Catheterization Laboratory, Cleveland Clinic, 9500 Euclid Ave, J2-3, Cleveland, OH 44195. Email: [email protected]Search for more papers by this authorRamyashree Tummala MD
Department of Internal Medicine, St. Vincent Charity Medical Center, An Affiliate of Case Western Reserve University, Cleveland, Ohio
N.B. Ramyashree Tummala and Kinjal Banerjee are equal contributors to this manuscript.
Search for more papers by this authorKinjal Banerjee MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
N.B. Ramyashree Tummala and Kinjal Banerjee are equal contributors to this manuscript.
Search for more papers by this authorKesavan Sankaramangalam MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorStephanie Mick MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorAmar Krishnaswamy MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorJonathon White MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorMaan Fares MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorAnand Mehta MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorZoran Popovic MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorLars G. Svensson MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Search for more papers by this authorCorresponding Author
Samir R. Kapadia MD
Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio
Correspondence Samir Kapadia, MD, Professor of Medicine, Director, Catheterization Laboratory, Cleveland Clinic, 9500 Euclid Ave, J2-3, Cleveland, OH 44195. Email: [email protected]Search for more papers by this authorAbstract
Objectives
The SAPIEN 3 valve (S3V) was designed to overcome the shortcomings of its predecessor, the SAPIEN XT (SXT) valve. We conducted a meta-analysis to compare their clinical outcomes and procedural characteristics.
Methods
PUBMED, EMBASE, and Cochrane CENTRAL were searched by two independent reviewers. The clinical outcomes of interest were paravalvular leakage (PVL), major vascular complications (MVC), bleeding, acute kidney injury (AKI), device success, need for post dilation all-cause mortality and procedural details.
Results
Fifteen observational cohort studies were included in the analysis involving a total of 4,496 patients. Of these, 1,700 were S3V recipients and 2,796 were SXT recipients. The S3V group showed fewer complications compared to the SXT group with respect to PVL (5.58% vs. 19.35%, OR: 0.27, P: 0.000), MVC (4.07% vs. 9.13%, OR: 0.44, P: 0.002), bleeding (6.40% vs. 12.03%, OR: 0.50, P: 0.003), 30-day mortality (3.29% vs. 5.68%, OR: 0.51, P: 0.000), and stroke (1.48% vs. 2.86%, OR: 0.49, P: 0.014). Device success was higher in the S3V (98.18% vs. 93.76%, OR: 3.14, P: 0.000). Cardiovascular mortality, myocardial infarction, AKI and post-dilatation were not significantly different. Permanent pacemaker implantation (PPI) was higher in S3V recipients (13.29% vs. 9.23%, OR: 1.58, P: 0.000). Procedure time was shorter for the S3V (71.94 vs. 86.85, P: 0.016) and used less contrast volume (129.36 vs. 161.18, P: 0.049).
Conclusions
Patients receiving the S3V had lower risk of PVL, MVC, bleeding, mortality, and stroke. PPI was somewhat higher in the S3V group. S3V implantation was faster and used less contrast.
Supporting Information
Additional Supporting Information may be found online in the supporting information tab for this article.
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