Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER‐I trial: Success and safety

Minha, Sa’ar; Waksman, Ron; Satler, Lowell; Torguson, Rebecca; Alli, Oluseun; Rihal, Charanjit S.; Mack, Michael J.; Svensson, Lars G.; Rajeswaran, Jeevanantham; Blackstone, Eugene H.; Tuzcu, E. Murat; Thourani, Vinod H.; Makkar, Raj; Ehrlinger, John; Lowry, Ashley M.; Suri, Rakesh M.; Greason, Kevin L.; Leon, Martin B.; Holmes, David R.; Pichard, Augusto D.

doi:10.1002/ccd.26121

Cited by 71 publications

(53 citation statements)

References 16 publications

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“…They concluded that TF-TAVR is preferred for inoperable patients at high risk of noncardiovascular mortality. Unlike TF-TAVR, however, 15,16 we found little evidence of a technical performance learning curve, and no suggestion that a technical learning curve is associated with adverse outcomes or prolonged postprocedure hospitalization after adjusting for patient factors.…”

Section: Discussioncontrasting

confidence: 60%

Learning curves for transapical transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance, success, and safety

Suri

Minha

Alli

et al. 2016

The Journal of Thoracic and Cardiovascular Surgery

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Objectives Introduction of hybrid techniques, such as transapical transcatheter aortic valve replacement (TA-TAVR), requires skills that a heart team must master to achieve technical efficiency: the technical performance learning curve. To date, the learning curve for TA-TAVR remains unknown. We therefore evaluated the rate at which technical performance improved, assessed change in occurrence of adverse events in relation to technical performance, and determined whether adverse events after TA-TAVR were linked to acquiring technical performance efficiency (the learning curve). Methods From April 2007 to February 2012, 1100 patients, average age 85.0 ± 6.4 years, underwent TA-TAVR in the PARTNER-I trial. Learning curves were defined by institution-specific patient sequence number using nonlinear mixed modeling. Results Mean procedure time decreased from 131 to 116 minutes within 30 cases (P = .06) and device success increased to 90% by case 45 (P = .0007). Within 30 days, 354 patients experienced a major adverse event (stroke in 29, death in 96), with possibly decreased complications over time (P ~ 08). Although longer procedure time was associated with more adverse events (P<.0001), these events were associated with change in patient risk profile, not the technical performance learning curve (P = .8). Conclusions The learning curve for TA-TAVR was 30 to 45 procedures performed, and technical efficiency was achieved without compromising patient safety. Although fewer patients are now undergoing TAVR via nontransfemoral access, understanding TA-TAVR learning curves and their relationship with outcomes is important as the field moves toward next-generation devices, such as those to replace the mitral valve, delivered via the left ventricular apex.

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Section: Discussioncontrasting

confidence: 60%

Learning curves for transapical transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance, success, and safety

Suri

Minha

Alli

et al. 2016

The Journal of Thoracic and Cardiovascular Surgery

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“…There are learning curves associated with TAVR . For instance, nonfemoral TAVR involves an important learning process, with 30–45 cases needed to reach a plateau for procedure time and device success .…”

Section: Structural Program Requirementsmentioning

confidence: 99%

“…Prior to expanding into alternative access, a new TAVR program should first complete at least 80 TAVRs using transfemoral access with an STS/ACC TVT Registry 30‐day all‐cause mortality above the bottom 25% of all TAVR programs for two consecutive quarters/year. The writing committee's consensus regarding the required 80 TAVR procedures was based on information from referenced articles and expert opinion . Alliances should be established between low‐volume, high‐quality programs serving geographic isolated areas, or programs caring for underserved populations and high‐volume, high‐quality programs to care for patients needing alternative access and the higher‐risk complex patient population needing TAVR.…”

Section: Criteria For Establishing a Tavr Program And Maintenance Of mentioning

confidence: 99%

2018 AATS/ACC/SCAI/STS expert consensus systems of care document: Operator and institutional recommendations and requirements for transcatheter aortic valve replacement

Bavaria

Tommaso

Brindis

et al. 2019

Cathet Cardio Intervent

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“…On one hand, there is a substantial increase in experience with TAVI that in turn has improved outcome [19, 20]. On the other, the number of different types and sizes of valve technologies increase as well [21].…”

Section: Introductionmentioning

confidence: 99%

Patient-specific computer modelling – its role in the planning of transcatheter aortic valve implantation

Faquir¹,

Ren²,

Mieghem³

et al. 2016

Neth Heart J

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Transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. As patient selection and operator experience have improved, it is hypothesised that device-host interactions will play a more dominant role in outcome. This, in combination with the increasing number of valve types and sizes, confronts the physician with the dilemma to choose the valve that best fits the individual patient. This necessitates the availability of pre-procedural computer simulation that is based upon the integration of the patient-specific anatomy, the physical and (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro experiments. The objective of this paper is to present such a model and illustrate its potential clinical utility via a few case studies.

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Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER‐I trial: Success and safety

Abstract: By end of trial, a consistent low risk of adverse events was achieved after ∼26 cases. However, these improved results were due to change in patient risk profile; outcomes were not linked to the technical performance learning curve. © 2015 Wiley Periodicals, Inc.

Cited by 71 publications

References 16 publications

Learning curves for transapical transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance, success, and safety

Learning curves for transapical transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance, success, and safety

2018 AATS/ACC/SCAI/STS expert consensus systems of care document: Operator and institutional recommendations and requirements for transcatheter aortic valve replacement

Patient-specific computer modelling – its role in the planning of transcatheter aortic valve implantation

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