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

ABSTRACT: 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).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.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).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.

SUBMITTER: Suri RM

PROVIDER: S-EPMC5127441 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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

Suri Rakesh M RM Minha Sa'ar S Alli Oluseun O Waksman Ron R Rihal Charanjit S CS Satler Lowell P LP Greason Kevin L KL Torguson Rebecca R Pichard Augusto D AD Mack Michael M Svensson Lars G LG Rajeswaran Jeevanantham J Lowry Ashley M AM Ehrlinger John J Mick Stephanie L SL Tuzcu E Murat EM Thourani Vinod H VH Makkar Raj R Holmes David D Leon Martin B MB Blackstone Eugene H EH

The Journal of thoracic and cardiovascular surgery 20160413 3

<h4>Objectives</h4>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 a ...[more]

PMID: 27215927

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Project description:BACKGROUND:Transcatheter aortic valve replacement (TAVR) is a fundamentally new procedure for the treatment of native aortic regurgitation (AR). The number of cases needed to gain proficiency with the procedure is unknown. HYPOTHESIS:This study aimed to evaluate the learning curve for TAVR for native AR. METHODS:This study retrospectively reviewed a prospective database from 134 consecutive native AR patients who underwent the J-valve TAVR system, which performed by a single team interventional cardiologist. The cumulative sum (CUSUM) method was used to analyze the learning curve. Patients were divided into two groups in chronological order, defined by the surgeon's early (group 1: the first 52 cases) and skilled (group 2: the next 82 cases) experience. Demographic data, intraoperative characteristics, and short-term surgical outcomes were compared between the two groups. RESULTS:CUSUM plots revealed decreasing procedure time and fluoroscopy time after patients 52 and 43, respectively. The patient date consistently demonstrated that high-risk scores and major perioperative parameters were comparable between the two groups. The use of contrast dye (group 1, 94.22?±?30.07?mL; group 2, 70.43?±?15.02?mL, P<.05), total procedure time (group 1, 84.96?± 17.76?minutes; group 2, 59.95?±?12.83?minutes, P<.05), and fluoroscopy time (group 1, 11.52?± 3.81?minutes; group 2, 6.47?±?1.53?minutes, P<.05) were significantly reduced in group 2. The overall device success rate in group 1 was 96.2% vs 96.3% in group 2 and remained high (P = 1.0). The overall 30-day mortality was 3.8% in group 2 (group 1, 0 to group 2, 3.8%; P = .16). The complications rate, such as pulmonary hypertension, chronic kidney disease, and coronary artery disease were higher in group 2. CONCLUSIONS:For a surgeon without previous TAVR experience, 52 cases of performance is the minimal requirement to gain the proficiency of TAVR for native AR. The skilled surgeons have been observed with reduced procedural time, fluoroscopy times, radiation exposure dose, and contrast volume usage. However, the overall prognosis was not significantly different between the two groups.

Project description:BackgroundTranscatheter aortic valve replacement (TAVR) has revolutionized the treatment of severe aortic stenosis in intermediate, high-risk, and inoperable patients. TAVR has multiple access routes, including transfemoral (TF), transapical (TA), direct aortic (DA), axillary, transcarotid, and transcaval. The most commonly applied algorithm is a TF-first approach, where only when patients are unsuitable for TF are alternatives such as TA considered. An infrequent - but dreaded - risk is left ventricular (LV) apical bleeding from tearing or rupture with the TA approach. With burgeoning transcatheter mitral technology that requires a TA approach, the study aim was to develop a mathematical model to determine suture forces for TA closure.MethodsPreoperative cine-cardiac magnetic resonance imaging (MRI) was used to acquire three-dimensional (3D) LV geometry at end-systole and end-diastole. Endocardial and epicardial boundaries were manually contoured using MeVisLab, a surface reconstruction software. 3D surfaces of endocardium and epicardium were reconstructed, and surfaces at end-systole were used to create a 3D LV finite element (FE) mesh. TA access was mimicked by developing a 10-mm defect within the LV FE model. The LV apex was closed using a virtual suture technique in FE analysis with the application of two virtual sutures. After virtual closure, a FE analysis was performed of LV model diastolic filling and systolic contraction.ResultsProof of concept was achieved to develop an LV transapical access site and perform FE analysis to achieve closure. The FE method of virtual suture technique successfully approximated the LV apical defect. The peak axial forces on virtual sutures at end-diastole and end-systole were 0.445N and 0.736N, respectively.ConclusionsA LV TA access model was mathematically developed that could be used to evaluate the suture tension of the TA closure process. Further development of this approach may be useful to risk-stratify patients in the future for LV apical tearing. Video 1: Cine cardiac magnetic resonance imaging of the left ventricle. Video 2: Slow motion animation of left ventricular baseline simulation. Video 3: Animation of the virtual suturing process.

Project description:To investigate the periprocedural inflammatory response in patients with isolated aortic valve stenosis undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) with different technical approaches.Patients were prospectively allocated to one of the following treatments: SAVR using conventional extracorporeal circulation (CECC, n = 47) or minimized extracorporeal circulation (MECC, n = 15), or TAVI using either transapical (TA, n = 15) or transfemoral (TF, n = 24) access. Exclusion criteria included infection, pre-procedural immunosuppressive or antibiotic drug therapy and emergency indications. We investigated interleukin (IL)-6, IL-8, IL-10, human leukocyte antigen (HLA-DR), white blood cell count, high-sensitivity C-reactive protein (hs-CRP) and soluble L-selectin (sCD62L) levels before the procedure and at 4, 24, and 48 h after aortic valve replacement. Data are presented for group interaction (p-values for inter-group comparison) as determined by the Greenhouse-Geisser correction.SAVR on CECC was associated with the highest levels of IL-8 and hs-CRP (p<0.017, and 0.007, respectively). SAVR on MECC showed the highest descent in levels of HLA-DR and sCD62L (both p<0.001) in the perioperative period. TA-TAVI showed increased intraprocedural concentration and the highest peak of IL-6 (p = 0.017). Significantly smaller changes in the inflammatory markers were observed in TF-TAVI.Surgical and interventional approaches to aortic valve replacement result in inflammatory modulation which differs according to the invasiveness of the procedure. As expected, extracorporeal circulation is associated with the most marked pro-inflammatory activation, whereas TF-TAVI emerges as the approach with the most attenuated inflammatory response. Factors such as the pre-treatment patient condition and the extent of myocardial injury also significantly affect inflammatory biomarker patterns. Accordingly, TA-TAVI is to be classified not as an interventional but a true surgical procedure, with inflammatory biomarker profiles comparable to those found after SAVR. Our study could not establish an obvious link between the extent of the periprocedural inflammatory response and clinical outcome parameters.

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

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

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