Transcatheter Aortic Valve Implantation

Alli, Oluseun; Booker, Jeffrey D.; Lennon, Ryan J.; Greason, Kevin L.; Rihal, Charanjit S.; Holmes, David R.

doi:10.1016/j.jcin.2011.09.014

Cited by 96 publications

(42 citation statements)

References 38 publications

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“…Indeed in the PARTNER RCT, the median number of TA-TAVR procedures was 4 (range, 1–20; Supplementary Appendix Figure 1). Recent studies have reported that the number of cases required to overcome the learning curve ranges from 18–100, 15–17 a level that far exceeded the experience of virtually all of the PARTNER centers at the time of the RCT. The current analysis was therefore performed to determine whether the HRQoL outcomes of TA-TAVR have improved with increasing operator and center experience.…”

Section: Discussionmentioning

confidence: 99%

Temporal Trends in Quality of Life Outcomes After Transapical Transcatheter Aortic Valve Replacement

Gada

Kirtane

Wang

et al. 2015

Circ: Cardiovascular Quality and Outcomes

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Background In the PARTNER randomized controlled trial (RCT), which represented the first exposure to transapical transcatheter aortic valve replacement (TA-TAVR) for many clinical sites, high risk patients undergoing TA-TAVR derived similar health-related quality-of-life (HRQoL) outcomes when compared with surgical AVR (SAVR). With increasing experience, it is possible that HRQoL outcomes of TA-TAVR may have improved. Methods and Results We evaluated HRQoL outcomes at 1-, 6-, and 12-month follow-up among 875 patients undergoing TA-TAVR in the PARTNER non-randomized continued access (NRCA) registry, and compared these outcomes with those of the TA-TAVR and SAVR patients in the PARTNER RCT. HRQoL was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short Form-12, and the EuroQoL-5D, with the KCCQ overall summary score serving as the primary endpoint. The NRCA TA-TAVR and RCT TA-TAVR and SAVR groups were generally similar. The primary outcome, the KCCQ summary score, did not differ between the NRCA TA-TAVR and the RCT TA-TAVR group at any follow-up timepoints, although there were small differences in favor of the NRCA cohort on several KCCQ subscales at 1 month. There were no significant differences in follow-up HRQOL between the NRCA-TAVR and the RCT SAVR cohorts on the KCCQ overall summary scale or any of the disease-specific or generic subscales. Conclusions Despite greater experience with TA-TAVR in the NRCA registry, HRQoL outcomes remained similar to those of TA-TAVR in the original RCT cohort and no better than those with SAVR. These findings have important implications for patient selection for TAVR when transfemoral access is not an option. Clinical Trial Registration Placement of AoRTic TraNscathetER Valve [PARTNER] trial; NCT00530894; http://clinicaltrials.gov/show/NCT00530894

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Section: Discussionmentioning

confidence: 99%

Temporal Trends in Quality of Life Outcomes After Transapical Transcatheter Aortic Valve Replacement

Gada

Kirtane

Wang

et al. 2015

Circ: Cardiovascular Quality and Outcomes

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“…As with introduction of any complex procedure, particularly one requiring a team approach, a set of skills must be mastered to achieve technical competence: the learning curve. 1,2 To date, the time necessary to traverse this learning phase for transapical (TA) TAVR remains unknown, and it is uncertain whether this learning curve compromises successful valve replacement and patient safety.…”

mentioning

confidence: 99%

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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“…However, a number of important differences between this and previous studies must be considered when interpreting these results. First, the learning curve effect associated with TAVI is well established . At the time recruitment for this study was commenced, the TAVI team performing all procedures had over 7 years' experience and had performed over 300 TAVI procedures.…”

Section: Discussionmentioning

confidence: 99%

Neurological Injury in Intermediate‐Risk Transcatheter Aortic Valve Implantation

Fanning

Wesley

Walters

et al. 2016

JAHA

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BackgroundThe application of transcatheter aortic valve implantation (TAVI) to intermediate‐risk patients is a controversial issue. Of concern, neurological injury in this group remains poorly defined. Among high‐risk and inoperable patients, subclinical injury is reported on average in 75% undergoing the procedure. Although this attendant risk may be acceptable in higher‐risk patients, it may not be so in those of lower risk.Methods and ResultsForty patients undergoing TAVI with the Edwards SAPIEN‐XT ™ prosthesis were prospectively studied. Patients were of intermediate surgical risk, with a mean±standard deviation Society of Thoracic Surgeons score of 5.1±2.5% and a EuroSCORE II of 4.8±2.4%; participant age was 82±7 years. Clinically apparent injury was assessed by serial National Institutes of Health Stroke Scale assessments, Montreal Cognitive Assessments (MoCA), and with the Confusion Assessment Method. These identified 1 (2.5%) minor stroke, 1 (2.5%) episode of postoperative delirium, and 2 patients (5%) with significant postoperative cognitive dysfunction. Subclinical neurological injury was assessed using brain magnetic resonance imaging, including diffusion‐weighted imaging (DWI) sequences preprocedure and at 3±1 days postprocedure. This identified 68 new DWI lesions present in 60% of participants, with a median±interquartile range of 1±3 lesions/patient and volumes of infarction of 24±19 μL/lesion and 89±218 μL/patient. DWI lesions were associated with a statistically significant reduction in early cognition (mean ΔMoCA −3.5±1.7) without effect on cognition, quality of life, or functional capacity at 6 months.ConclusionsObjectively measured subclinical neurological injuries remain a concern in intermediate‐risk patients undergoing TAVI and are likely to manifest with early neurocognitive changes.Clinical Trial Registration URL: http://www.anzctr.org.au. Australian & New Zealand Clinical Trials Registry: ACTRN12613000083796.

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Transcatheter Aortic Valve Implantation

Cited by 96 publications

References 38 publications

Temporal Trends in Quality of Life Outcomes After Transapical Transcatheter Aortic Valve Replacement

Temporal Trends in Quality of Life Outcomes After Transapical Transcatheter Aortic Valve Replacement

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

Neurological Injury in Intermediate‐Risk Transcatheter Aortic Valve Implantation

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