- Email: [email protected]
TCT-747 Transcatheter Aortic Valve Replacement: Assessment of the Learning Curve Based on the PARTNER Trial
www.jacctctabstracts2013.com
TUESDAY, OCTOBER 29, 2013, 3:30 PM–5:30 PM
Table 1. Transcatheter aortic valve movement during valve deployment Device Movement (midline), (mm)
p
Valve Type SAPIEN (n ¼ 53)
2.391.64
SAPIEN XT (n ¼ 31)
2.541.65
TCT-746 0.686
Cerebral Ischemic Lesions after Percutaneous Transfemoral Aortic Valve Implantation: Comparison between Edwards Sapien XT versus Direct Flow Medical Valve Prosthesis
Valve Size (mm) 23 (n ¼ 25)
2.171.83
26 (n ¼ 51)
2.431.58
29 (n ¼ 8)
3.411.02
Transfemoral (TF), (n ¼ 72)
2.451.65
Transapical (TA), (n ¼ 8)
2.341.65
Transaortic (Tao), (n ¼ 4)
2.611.72
0.53 (23 vs.26) 0.077 (23 vs.29) 0.095 (26 vs.29)
Access 0.87 (TF vs. TA) 0.84 (TF vs. Tao) 0.80 (TA vs. Tao)
AV Area (cm2) <0.67 (n ¼ 41)
2.471.79
0.67 (n ¼ 43)
2.421.50
0.89
Aortic Annulus Diameter (mm) <23 (n ¼ 38)
2.371.77
23 (n ¼ 46)
2.501.53
0.72
Interventricular septal thickness (mm) >1.3 (n ¼ 53)
2.38 1.57
1.3 (n ¼ 31)
2.55 1.76
0.65
Valve Calcification by TEE no/mild (n ¼ 39)
2.411.54
moderate/severe (n ¼ 45)
2.471.73
0.85
Sinus Volume (cm3) by TEE <7.6 (n ¼ 42)
2.371.70
7.6 (n ¼ 42)
2.521.58
dimensions were measured. TEE and CT diameters were used to determine oversizing. Significant paravalvular leak (PVL) (grade 2) was the primary clinical outcome measure. Results: TEE-derived diameters were significantly smaller than CT-based measurements (p<0.0001). According to TEE and CTperimeter, 95.5% and 78.3% were suitable for CoreValve implantation (26/29mm), respectively. Using TEE, 80.9% received the appropriate valve size, while CTperimeter suggested that only 51.0% met oversizing criteria. The average oversizing with TEE 20.28.3% compared to 10.18.6% with CTperimeter. After CoreValve implantation, 38 (24.2%) patients had significant PVL. PVL was similar among patients that satisfied and those that did not satisfy sizing criteria using TEE (23.6%vs26.7%,p¼0.813). When CT data was applied, PVL was significantly lower in those that satisfied sizing criteria (CTperimeter: 13.8%vs35.1%,p¼0.0026). Adherence to CT but not TEE-sizing, was associated with a reduction in PVL (CTperimeter:odds ratio:0.30;95% CI:0. 13-0.65,p¼0.002). Sensitivity-specificity curves for CTperimeter identified minimal oversizing thresholds of 9.0% and 9.6% for the 26 and 29mm CoreValves that best predicted PVL. Conclusions: Compared to TEE, CT-based THV-sizing yields larger annular diameters, changes the selected valve size in half of all patients, and is predictive of PVL. CTperimeter is the most sensitive CT measurement for predicting PVL.
0.68
Klaudija Bijuklic1, Andreas Wandler2, Joachim Schofer3 Medical Care Center, Hamburg, Germany, 2Medical Care Center Prof. Mathey Prof. Schofer, Hamburg, Germany, 3Medicare center Prof Mathey, Prof Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany
1
Background: Objectives: To compare the cerebral embolic load, assessed by diffusion weighted magnetic resonance imaging (DW-MRI), after percutaneous implantation of Edwards Sapien XT (SXT) versus Direct Flow Medical aortic valve (DFM) implantation. Background: New cerebral ischemic lesions after percutaneous implantation of commercially available aortic valves are found in more than 80% of patients. The DFM is a non-metallic prosthesis, which is placed pulling it through the left ventricular outflow tract up to the aortic annulus, jailing the native valve behind a polymer cuff. It is unknown whether this impacts the risk of cerebral embolization. Methods: We performed a DW-MRI the day before and 48 to 72 h after TAVI. DWMRI studies were blindly analyzed by a radiologist, and all patients had a neurological assessment before and after the procedure. Results: In 36 consecutive patients (mean age 82.8 4.9 years, 56 % male) with severe symptomatic aortic stenosis and high surgical risk were studied. In a SXT (16 pts), a DFM (20 pts) was successfully implanted via the femoral artery. There was no difference in patient demographics as well as in the log EuroScore and in comorbidities between both groups. All pts underwent a balloon valvuloplasty before and 1 pt with SXT also after valve implantation. None of the pts had a stroke or TIA. The incidence of new cerebral ischemic lesions did not differ significantly in with DFM compared to SXT pts. (17/20, 85%, versus 10/16, 62.5%, p¼0.12). However, new ischemic lesions were more frequently found in both hemispheres in DFM compared to SXT patients (55% vs. 18.8%, p¼0.03). The number of ischemic lesions per patient was significantly higher in DFM patients (3.3 2.6 for DFM vs 1.7 2.5 for SXT, p¼0.049). For the volume of lesions there was a trend in favour of SXT (0.17 ml 0.3 cm3 vs.0.34 ml 0.56cm3, p¼0.2). Conclusions: The type of valve prosthesis for percutaneous treatment of severe aortic stenosis may have an impact on cerebral embolization. TCT-747
*consecutive patients who had cardiac CT angiography as part of preoperative evaluation.
Transcatheter Aortic Valve Replacement: Assessment of the Learning Curve Based on the PARTNER Trial TCT-745 CoreValve Oversizing Using Multislice Computed Tomography and Clinical Outcomes: A Comparison with Transesophageal Echocardiography Darren Mylotte1, Magdelena Dorfmeister2, Yacine Elhmidi3, Domenico Mazzitelli3, Sabine Bleiziffer3, Rudiger Lange3, Nicolo Piazza4 1 McGill University Health Center, Royal Victoria Hospital, Montreal, Quebec, 2 German Heart Centre, Munich, Bavaria, 3German Heart Center Munich, Munich, Germany, 4McGill University Health Center, Royal Victoria Hospital, Montreal, Canada Background: Accurate measurement of the aortic annulus and adherence to oversizing principles are crucial for transcatheter aortic valve replacement (TAVR). We sought to assess adherence to transcatheter heart valve (THV) oversizing principles according to transesophageal echocardiography (TEE) and computed tomography (CT) and to evaluate the relationship between the adherence to oversizing and clinical outcome. Methods: Between 2009 and 2010, 157 aortic stenosis patients underwent screening CT prior to CoreValve implantation. During this early experience, CT was performed only to evaluate the peripheral vasculature. In all cases, TAVR-sizing was performed using TEE. CT datasets were retrospectively reconstructed and the CTmean, CTarea, and CTperimeter
JACC Vol 62/18/Suppl B
j
October 27–November 1, 2013
j
Oluseun Alli1, Charanjit Rihal2, Rakesh Suri2, Kevin Greason2, Ron Waksman3, Sa'ar Minha4, Rebecca Torguson5, Augusto Pichard6, Michael Mack7, Lars Svensson8, Jeevanantham Rajeswaran9, Ashley M. Lowry9, Eugene Blackstone9, E. Murat Tuzcu10, Vinod Thourani11, Raj Makkar12, Martin Leon13, David Holmes Jr14 1 University of Alabama at Birmingham, Birmingham, AL, 2Mayo Clinic, Rochester, MN, 3MedStar Health Research Institute, Washington, DC, 4MedStar Washington Hospital Center, Washington, DC, 5Washington Hospital center, washington, DC, 6 washsington hospital center, Washington, United States, 7Baylor Healthcare System, Plano, United States, 8Cleveland Clinic, Cleveland, USA, 9Cleveland Clinic, Cleveland, OH, 10Cleveland Clinic Foundation, Cleveland, Ohio, 11Emory University, Atlanta, GA, 12Associate Prof, UCLA school of Medicine, Los Angeles, California, 13 Cardiovascular Research Foundation, New York, NY, 14Mayo Clinic College of Medicine, Rochester, United States Background: Transcatheter aortic-valve replacement (TAVR) is a new procedure for the treatment of severe aortic stenosis. The number of cases require to gain proficiency "learning curve" is unknown. The aim of this study is to assess the learning curve of the team involved in the performance of TAVR in the PARTNER trial. We hypothesized that a) a quantifiable learning curve exists for TAVR and b) process measures of procedural proficiency would improve with increasing case volumes
TCT Abstracts/POSTER/Aortic Valve Disease and Treatment
B227
POSTERS
Results: Eighty four patients were included in the final analysis. Device position postdeployment was significantly higher than pre-deployment (16.112.5% vs. 33.712.5%, p<0.0001). Operator-independent cranial movement during deployment was 2.41.6 mm (range -0.35 to 6.8 mm). There was foreshortening of the device during deployment with lower edge of the valve moving farther cranially than the upper edge (3.61.7 vs. 1.31.6 mm, p <0.0001). This movement was similar between valve versions and vascular access. There was a trend (p ¼ 0.09) for more movement with the 29 mm valve. Valve movement was not significantly related to echo parameters listed in Table 1. Conclusions: Operator-independent cranial movement of the balloon-expandable transcatheter valve occurs during its deployment. There is device foreshortening with deployment explained by the fact that caudal edge of the device moves farther than the cranial edge. This deployment movement of the device can be characterized by TEE and may help with positioning immediately prior to valve deployment.
www.jacctctabstracts2013.com
POSTERS
TUESDAY, OCTOBER 29, 2013, 3:30 PM–5:30 PM
Methods: 2,621 patients underwent TAVR with the SAPIEN heart valve via TF (N¼1521) or TA (N¼1100) delivery routes between April 2007 and January 2012. The study was divided into 2 time domains for this analysis, 1st half (2007 – 2009) and 2nd half (2010 – 2012). The Shapes of the learning curves were assessed using a semi-parametric mixed effects model. Results: Figure 1A details the outcomes of the technical performance variables. Using the date of implant, there appeared to be a significant downward trend in procedure times (Figure 1B), fluoroscopy times and contrast volume. (Figure 1C and D) The improvement in these parameters was particularly striking in TF cases p < 0.005.
perimeter. Aim of our study was to compare MSCT results with direct intraoperative sizing of the annulus. Methods: Conventional aortic valve replacement was performed in 25 patients who were primarily screened for TAVI, but were deemed inappropriate for several reasons, and the annulus was measured intraoperatively after decalcification using metric sizers. All patients had undergone transesophageal echocardiography (TEE) and MSCT for TAVI workup and effective annulus diameter was determined derived by area (AsysA, AdiaA) and perimeter (AsysP, AdiaP) in systole and diastole, respectively. Additionally, potential change of strategy for the different approaches compared to intraoperative annulus sizing in case of TAVI using the Edwards Sapien XT valve was simulated. Results: Best agreement with direct operative sizing (intraop) was observed for AsysA in the Bland-Altman analysis (mean difference between intraop vs. AsysA -0.17 mm, limits of agreement -1.98 – 1.64; intraop vs. AdiaA 0.65 mm, limits of agreement -1.56 to 2.86; intraop vs. AsysP -0.92 mm, limits of agreement -2.81 to 0.97 and intraop vs. AdiaP -0.29 mm, limits of agreement -2.85 to 2.27), TEE 1.5 mm, limits of agreement -2.77 to 2.27). Least change of strategy would have occurred with AsysA (20%), followed by AdiaP (28%), AdiaA (30%) and AsysP (40%). Conclusions: Compared to surgical sizing area derived measurement in systole represents the best approach for annulus determination with least strategy change. Perimeter derived measurement in systole may lead to overestimation of the true annulus size. TCT-750 Positioning and Implantation of the Direct Flow Medical Transcatheter Heart Valve without contrast media
Conclusions: Our results demonstrate that in the PARTNER trial there is an important TAVR learning curve with significant improvement in procedural and performance variables over time. Although the differences in primary operator skill sets between TA and TF approaches may explain some of the observed heterogeneity in learning curves, a critical volume of cases appears necessary to become proficient in the safe performance of TAVR, particularly via the TF route.
Azeem Latib1, Giuseppe Bruschi2, Antonio Colombo3, Charles J. Davidson4, Federico De Marco2, Silvio Klugmann2, Francesco Maisano5, Joachim Schofer6 1 San Raffaele Scientific Institute, Milan, Italy, 2Niguarda Ca’ Granda Hospital, Milan, Italy, 3EMO GVM Centro Cuore Columbus/San Raffaele Hospital, Milan, Italy, 4Northwestern Memorial Hospital, Chicago, Illinois, 5San Raffaele Hospital, Milan, Italy, 6Medicare center Prof Mathey, Prof Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany
TCT-748 Incidence And Prognosis Of Acute Kidney Injury After Transcatheter Aortic Valve Implantation Jorge Cortés-Lawrenz1, Manuel Muñoz-García1, Erika Muñoz-García1, Manuel Jimenez Navarro2, Antonio Domínguez-Franco1, Juan Alonso Briales3, Jose María Hernandez-García1 1 Hospital Clínico Virgen de la Victoria Málaga España, Málaga , Spain, 2H. Virgen de la Victoria, Malaga, Spain, 3Hospital Virgen de la Victoria, Malaga, Spain Background: Acute Kidney injury (AKI) after cardiac surgery is associated with increased mortality, but very few data exist on the occurrence of AKI associated with Transcatheter Aortic Valve Implantation (TAVI). The objective of this study was to determine the incidence and prognosis of AKI after percutaneous implantation of the CoreValve aortic prosthesis. Methods: Between April-2008 and January-2011, 223 patients with severe aortic stenosis were treated with the CoreValve prosthesis. The AKI was defined according to Valve set by the Academic Research Consortium, as the absolute increase in serum creatinine 0.3 mg/dl at 72 hours a percutaneous procedure. Results: AKI was identified in 37 patients (16.6%) and none required renal replacement therapy. After implantation there was a slight improvement in renal function, baseline serum creatinine decreased from 1.290.5 mg/dl to 1.22 mg/dl, P¼0.023 and glomerular filtration rate (GFR) increased from 49.622 to 5223, P¼0.015. In patients with AKI, the mortality at 30 days was 13.5 % compared to 1.6% of patients without AKI, P¼0.001 and late mortality after a mean of 16.711 months was 18.8% in those patients with AKI compared to 8.2% in those without AKI, P¼0.068. In the multivariate analysis AKI was an independent predictor of cumulative total mortality (HR¼3.516, 95% CI from 1.098 to 11.255, P¼0.034). Conclusions: Deterioration of renal function in patients undergoing TAVI with the CoreValve prosthesis is a serious and frequent complication. The occurrence of AKI was associated with increase early mortality and also was a predictor of worse outcomes in the long-term follow-up.
Background: The 18F Direct Flow Medical (DFM) THV has conformable sealing rings which minimizes aortic regurgitation and permits full hemodynamic assessment of valve performance prior to permanent implantation. Methods: The DISCOVER trial was a prospective, multicenter evaluation of 100 patients who underwent TAVI with the DFM THV. Within this study, 3 patients were at risk for receiving contrast media: 2 due to severe CKD (eGFR < 30 mL/min/1.73 m2) and 1 due to a recent hyperthyroid reaction to contrast. The valve was positioned under fluoroscopic and transesophageal guidance without aortography during either positioning or to confirm the final position. Valve positioning was based on the optimal angiographic projection as calculated by the pre-procedural multi-slice CT scan. Precise optimization of valve position was performed to minimize transvalve gradient and aortic regurgitation. Prior to final implantation, transvalve hemodynamics were assessed invasively and by TEE. Results: The average age was 81 years. The baseline logistic EuroSCORE were 15, 18 and 24. LVEF was 33, 40, and 62%. The post procedure mean gradients were 7, 10, 11 mmHg. The final AVA by echo was 1.70, 1.40 and 1.68 cm2. Total aortic regurgitation post procedure was none or trace in all 3 patients. Total positioning and assessment of valve performance time was 4, 6, and 12 minutes, and total skin to skin procedure time were 29, 47, and 64 minutes. A 25mm valve was used in all 3. There was 100% freedom from all cause mortality at 30 days. VARC defined device success was 100% and patient safety freedom from events was 100%. One had a permanent pacemaker due to AV block. Contrast was only used to confirm successful percutaneous closure of the femoral access site. The total contrast dose was 5, 8, 12 cc. Baseline eGFR and creatinine was 28, 22, 74 mL/mn/1.73 m2 and 2.35, 2.98, and 1.03 mg/dL, respectively. Renal function was unchanged post procedure: eGFR¼25, 35, and 96 mL/mn/1.73 m2 and creatinine¼2.58, 1.99, and 1.03 mg/dL, respectively. Conclusions: The DFM THV provides the ability to perform TAVI with minimal or no contrast. The precise and predictable implantation technique can be performed with fluoro and echo guidance. TCT-751 Aortic Stenosis in the Elderly: number of TAVR candidates
TCT-749 Comparison of Area and Perimeter Derived Effective Annulus Diameter with Direct Intraoperative Sizing Won-Keun Kim1, Helge Moellmann1, Andreas Rolf1, Christoph Liebetrau1, Johannes Blumenstein1, Arnaud Van Linden1, Christian W. Hamm2, Thomas Walther2, Joerg Kempfert2 1 Kerckhoff Heart Center, Bad Nauheim, Germany, 2Kerckhhoff Heart Center, Bad Nauheim, Germany Background: Accurate sizing of the aortic annulus is an important premise for successful Transcatheter aortic valve implantation (TAVI). Multislice computed tomography (MSCT) may have advantages over other imaging modalities, but there is uncertainty whether 1) measurements should be performed in systole or diastole and 2) if calculation of the effective annulus diameter should be based on area or
B228
JACC Vol 62/18/Suppl B
j
Ruben L. J. Osnabrugge1, Darren Mylotte2, Stuart J. Head1, Nicolas M Van Mieghem3, Vuyisile T. Nkomo4, Corinne Le Reun5, Ad J. Bogers1, Nicolo Piazza6, A. Pieter Kappetein3 1 Erasmus University Medical Center, Rotterdam, Netherlands, 2McGill University Health Center, Royal Victoria Hospital, Montreal, Quebec, 3Erasmus MC, Rotterdam, Netherlands, 4Mayo Clinic, Rochester, MN, 5Biostatistician, Carrigaline, Ireland, 6 McGill University Health Center, Royal Victoria Hospital, Montreal, Canada Background: Severe AS is a leading cause of morbidity and mortality in elderly.A proportion of patients is now considered for transcatheter aortic valve replacement (TAVR).We i) performed a meta-analysis on the prevalence of AS in the elderly and ii) systematically estimated the number of candidates for TAVR. Methods: A systematic search was conducted in multiple databases and prevalence rates of patients (>75 years) were pooled.A model was based on a second systematic
October 27–November 1, 2013
j
TCT Abstracts/POSTER/Aortic Valve Disease and Treatment
TUESDAY, OCTOBER 29, 2013, 3:30 PM–5:30 PM
Table 1. Transcatheter aortic valve movement during valve deployment Device Movement (midline), (mm)
p
Valve Type SAPIEN (n ¼ 53)
2.391.64
SAPIEN XT (n ¼ 31)
2.541.65
TCT-746 0.686
Cerebral Ischemic Lesions after Percutaneous Transfemoral Aortic Valve Implantation: Comparison between Edwards Sapien XT versus Direct Flow Medical Valve Prosthesis
Valve Size (mm) 23 (n ¼ 25)
2.171.83
26 (n ¼ 51)
2.431.58
29 (n ¼ 8)
3.411.02
Transfemoral (TF), (n ¼ 72)
2.451.65
Transapical (TA), (n ¼ 8)
2.341.65
Transaortic (Tao), (n ¼ 4)
2.611.72
0.53 (23 vs.26) 0.077 (23 vs.29) 0.095 (26 vs.29)
Access 0.87 (TF vs. TA) 0.84 (TF vs. Tao) 0.80 (TA vs. Tao)
AV Area (cm2) <0.67 (n ¼ 41)
2.471.79
0.67 (n ¼ 43)
2.421.50
0.89
Aortic Annulus Diameter (mm) <23 (n ¼ 38)
2.371.77
23 (n ¼ 46)
2.501.53
0.72
Interventricular septal thickness (mm) >1.3 (n ¼ 53)
2.38 1.57
1.3 (n ¼ 31)
2.55 1.76
0.65
Valve Calcification by TEE no/mild (n ¼ 39)
2.411.54
moderate/severe (n ¼ 45)
2.471.73
0.85
Sinus Volume (cm3) by TEE <7.6 (n ¼ 42)
2.371.70
7.6 (n ¼ 42)
2.521.58
dimensions were measured. TEE and CT diameters were used to determine oversizing. Significant paravalvular leak (PVL) (grade 2) was the primary clinical outcome measure. Results: TEE-derived diameters were significantly smaller than CT-based measurements (p<0.0001). According to TEE and CTperimeter, 95.5% and 78.3% were suitable for CoreValve implantation (26/29mm), respectively. Using TEE, 80.9% received the appropriate valve size, while CTperimeter suggested that only 51.0% met oversizing criteria. The average oversizing with TEE 20.28.3% compared to 10.18.6% with CTperimeter. After CoreValve implantation, 38 (24.2%) patients had significant PVL. PVL was similar among patients that satisfied and those that did not satisfy sizing criteria using TEE (23.6%vs26.7%,p¼0.813). When CT data was applied, PVL was significantly lower in those that satisfied sizing criteria (CTperimeter: 13.8%vs35.1%,p¼0.0026). Adherence to CT but not TEE-sizing, was associated with a reduction in PVL (CTperimeter:odds ratio:0.30;95% CI:0. 13-0.65,p¼0.002). Sensitivity-specificity curves for CTperimeter identified minimal oversizing thresholds of 9.0% and 9.6% for the 26 and 29mm CoreValves that best predicted PVL. Conclusions: Compared to TEE, CT-based THV-sizing yields larger annular diameters, changes the selected valve size in half of all patients, and is predictive of PVL. CTperimeter is the most sensitive CT measurement for predicting PVL.
0.68
Klaudija Bijuklic1, Andreas Wandler2, Joachim Schofer3 Medical Care Center, Hamburg, Germany, 2Medical Care Center Prof. Mathey Prof. Schofer, Hamburg, Germany, 3Medicare center Prof Mathey, Prof Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany
1
Background: Objectives: To compare the cerebral embolic load, assessed by diffusion weighted magnetic resonance imaging (DW-MRI), after percutaneous implantation of Edwards Sapien XT (SXT) versus Direct Flow Medical aortic valve (DFM) implantation. Background: New cerebral ischemic lesions after percutaneous implantation of commercially available aortic valves are found in more than 80% of patients. The DFM is a non-metallic prosthesis, which is placed pulling it through the left ventricular outflow tract up to the aortic annulus, jailing the native valve behind a polymer cuff. It is unknown whether this impacts the risk of cerebral embolization. Methods: We performed a DW-MRI the day before and 48 to 72 h after TAVI. DWMRI studies were blindly analyzed by a radiologist, and all patients had a neurological assessment before and after the procedure. Results: In 36 consecutive patients (mean age 82.8 4.9 years, 56 % male) with severe symptomatic aortic stenosis and high surgical risk were studied. In a SXT (16 pts), a DFM (20 pts) was successfully implanted via the femoral artery. There was no difference in patient demographics as well as in the log EuroScore and in comorbidities between both groups. All pts underwent a balloon valvuloplasty before and 1 pt with SXT also after valve implantation. None of the pts had a stroke or TIA. The incidence of new cerebral ischemic lesions did not differ significantly in with DFM compared to SXT pts. (17/20, 85%, versus 10/16, 62.5%, p¼0.12). However, new ischemic lesions were more frequently found in both hemispheres in DFM compared to SXT patients (55% vs. 18.8%, p¼0.03). The number of ischemic lesions per patient was significantly higher in DFM patients (3.3 2.6 for DFM vs 1.7 2.5 for SXT, p¼0.049). For the volume of lesions there was a trend in favour of SXT (0.17 ml 0.3 cm3 vs.0.34 ml 0.56cm3, p¼0.2). Conclusions: The type of valve prosthesis for percutaneous treatment of severe aortic stenosis may have an impact on cerebral embolization. TCT-747
*consecutive patients who had cardiac CT angiography as part of preoperative evaluation.
Transcatheter Aortic Valve Replacement: Assessment of the Learning Curve Based on the PARTNER Trial TCT-745 CoreValve Oversizing Using Multislice Computed Tomography and Clinical Outcomes: A Comparison with Transesophageal Echocardiography Darren Mylotte1, Magdelena Dorfmeister2, Yacine Elhmidi3, Domenico Mazzitelli3, Sabine Bleiziffer3, Rudiger Lange3, Nicolo Piazza4 1 McGill University Health Center, Royal Victoria Hospital, Montreal, Quebec, 2 German Heart Centre, Munich, Bavaria, 3German Heart Center Munich, Munich, Germany, 4McGill University Health Center, Royal Victoria Hospital, Montreal, Canada Background: Accurate measurement of the aortic annulus and adherence to oversizing principles are crucial for transcatheter aortic valve replacement (TAVR). We sought to assess adherence to transcatheter heart valve (THV) oversizing principles according to transesophageal echocardiography (TEE) and computed tomography (CT) and to evaluate the relationship between the adherence to oversizing and clinical outcome. Methods: Between 2009 and 2010, 157 aortic stenosis patients underwent screening CT prior to CoreValve implantation. During this early experience, CT was performed only to evaluate the peripheral vasculature. In all cases, TAVR-sizing was performed using TEE. CT datasets were retrospectively reconstructed and the CTmean, CTarea, and CTperimeter
JACC Vol 62/18/Suppl B
j
October 27–November 1, 2013
j
Oluseun Alli1, Charanjit Rihal2, Rakesh Suri2, Kevin Greason2, Ron Waksman3, Sa'ar Minha4, Rebecca Torguson5, Augusto Pichard6, Michael Mack7, Lars Svensson8, Jeevanantham Rajeswaran9, Ashley M. Lowry9, Eugene Blackstone9, E. Murat Tuzcu10, Vinod Thourani11, Raj Makkar12, Martin Leon13, David Holmes Jr14 1 University of Alabama at Birmingham, Birmingham, AL, 2Mayo Clinic, Rochester, MN, 3MedStar Health Research Institute, Washington, DC, 4MedStar Washington Hospital Center, Washington, DC, 5Washington Hospital center, washington, DC, 6 washsington hospital center, Washington, United States, 7Baylor Healthcare System, Plano, United States, 8Cleveland Clinic, Cleveland, USA, 9Cleveland Clinic, Cleveland, OH, 10Cleveland Clinic Foundation, Cleveland, Ohio, 11Emory University, Atlanta, GA, 12Associate Prof, UCLA school of Medicine, Los Angeles, California, 13 Cardiovascular Research Foundation, New York, NY, 14Mayo Clinic College of Medicine, Rochester, United States Background: Transcatheter aortic-valve replacement (TAVR) is a new procedure for the treatment of severe aortic stenosis. The number of cases require to gain proficiency "learning curve" is unknown. The aim of this study is to assess the learning curve of the team involved in the performance of TAVR in the PARTNER trial. We hypothesized that a) a quantifiable learning curve exists for TAVR and b) process measures of procedural proficiency would improve with increasing case volumes
TCT Abstracts/POSTER/Aortic Valve Disease and Treatment
B227
POSTERS
Results: Eighty four patients were included in the final analysis. Device position postdeployment was significantly higher than pre-deployment (16.112.5% vs. 33.712.5%, p<0.0001). Operator-independent cranial movement during deployment was 2.41.6 mm (range -0.35 to 6.8 mm). There was foreshortening of the device during deployment with lower edge of the valve moving farther cranially than the upper edge (3.61.7 vs. 1.31.6 mm, p <0.0001). This movement was similar between valve versions and vascular access. There was a trend (p ¼ 0.09) for more movement with the 29 mm valve. Valve movement was not significantly related to echo parameters listed in Table 1. Conclusions: Operator-independent cranial movement of the balloon-expandable transcatheter valve occurs during its deployment. There is device foreshortening with deployment explained by the fact that caudal edge of the device moves farther than the cranial edge. This deployment movement of the device can be characterized by TEE and may help with positioning immediately prior to valve deployment.
www.jacctctabstracts2013.com
POSTERS
TUESDAY, OCTOBER 29, 2013, 3:30 PM–5:30 PM
Methods: 2,621 patients underwent TAVR with the SAPIEN heart valve via TF (N¼1521) or TA (N¼1100) delivery routes between April 2007 and January 2012. The study was divided into 2 time domains for this analysis, 1st half (2007 – 2009) and 2nd half (2010 – 2012). The Shapes of the learning curves were assessed using a semi-parametric mixed effects model. Results: Figure 1A details the outcomes of the technical performance variables. Using the date of implant, there appeared to be a significant downward trend in procedure times (Figure 1B), fluoroscopy times and contrast volume. (Figure 1C and D) The improvement in these parameters was particularly striking in TF cases p < 0.005.
perimeter. Aim of our study was to compare MSCT results with direct intraoperative sizing of the annulus. Methods: Conventional aortic valve replacement was performed in 25 patients who were primarily screened for TAVI, but were deemed inappropriate for several reasons, and the annulus was measured intraoperatively after decalcification using metric sizers. All patients had undergone transesophageal echocardiography (TEE) and MSCT for TAVI workup and effective annulus diameter was determined derived by area (AsysA, AdiaA) and perimeter (AsysP, AdiaP) in systole and diastole, respectively. Additionally, potential change of strategy for the different approaches compared to intraoperative annulus sizing in case of TAVI using the Edwards Sapien XT valve was simulated. Results: Best agreement with direct operative sizing (intraop) was observed for AsysA in the Bland-Altman analysis (mean difference between intraop vs. AsysA -0.17 mm, limits of agreement -1.98 – 1.64; intraop vs. AdiaA 0.65 mm, limits of agreement -1.56 to 2.86; intraop vs. AsysP -0.92 mm, limits of agreement -2.81 to 0.97 and intraop vs. AdiaP -0.29 mm, limits of agreement -2.85 to 2.27), TEE 1.5 mm, limits of agreement -2.77 to 2.27). Least change of strategy would have occurred with AsysA (20%), followed by AdiaP (28%), AdiaA (30%) and AsysP (40%). Conclusions: Compared to surgical sizing area derived measurement in systole represents the best approach for annulus determination with least strategy change. Perimeter derived measurement in systole may lead to overestimation of the true annulus size. TCT-750 Positioning and Implantation of the Direct Flow Medical Transcatheter Heart Valve without contrast media
Conclusions: Our results demonstrate that in the PARTNER trial there is an important TAVR learning curve with significant improvement in procedural and performance variables over time. Although the differences in primary operator skill sets between TA and TF approaches may explain some of the observed heterogeneity in learning curves, a critical volume of cases appears necessary to become proficient in the safe performance of TAVR, particularly via the TF route.
Azeem Latib1, Giuseppe Bruschi2, Antonio Colombo3, Charles J. Davidson4, Federico De Marco2, Silvio Klugmann2, Francesco Maisano5, Joachim Schofer6 1 San Raffaele Scientific Institute, Milan, Italy, 2Niguarda Ca’ Granda Hospital, Milan, Italy, 3EMO GVM Centro Cuore Columbus/San Raffaele Hospital, Milan, Italy, 4Northwestern Memorial Hospital, Chicago, Illinois, 5San Raffaele Hospital, Milan, Italy, 6Medicare center Prof Mathey, Prof Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany
TCT-748 Incidence And Prognosis Of Acute Kidney Injury After Transcatheter Aortic Valve Implantation Jorge Cortés-Lawrenz1, Manuel Muñoz-García1, Erika Muñoz-García1, Manuel Jimenez Navarro2, Antonio Domínguez-Franco1, Juan Alonso Briales3, Jose María Hernandez-García1 1 Hospital Clínico Virgen de la Victoria Málaga España, Málaga , Spain, 2H. Virgen de la Victoria, Malaga, Spain, 3Hospital Virgen de la Victoria, Malaga, Spain Background: Acute Kidney injury (AKI) after cardiac surgery is associated with increased mortality, but very few data exist on the occurrence of AKI associated with Transcatheter Aortic Valve Implantation (TAVI). The objective of this study was to determine the incidence and prognosis of AKI after percutaneous implantation of the CoreValve aortic prosthesis. Methods: Between April-2008 and January-2011, 223 patients with severe aortic stenosis were treated with the CoreValve prosthesis. The AKI was defined according to Valve set by the Academic Research Consortium, as the absolute increase in serum creatinine 0.3 mg/dl at 72 hours a percutaneous procedure. Results: AKI was identified in 37 patients (16.6%) and none required renal replacement therapy. After implantation there was a slight improvement in renal function, baseline serum creatinine decreased from 1.290.5 mg/dl to 1.22 mg/dl, P¼0.023 and glomerular filtration rate (GFR) increased from 49.622 to 5223, P¼0.015. In patients with AKI, the mortality at 30 days was 13.5 % compared to 1.6% of patients without AKI, P¼0.001 and late mortality after a mean of 16.711 months was 18.8% in those patients with AKI compared to 8.2% in those without AKI, P¼0.068. In the multivariate analysis AKI was an independent predictor of cumulative total mortality (HR¼3.516, 95% CI from 1.098 to 11.255, P¼0.034). Conclusions: Deterioration of renal function in patients undergoing TAVI with the CoreValve prosthesis is a serious and frequent complication. The occurrence of AKI was associated with increase early mortality and also was a predictor of worse outcomes in the long-term follow-up.
Background: The 18F Direct Flow Medical (DFM) THV has conformable sealing rings which minimizes aortic regurgitation and permits full hemodynamic assessment of valve performance prior to permanent implantation. Methods: The DISCOVER trial was a prospective, multicenter evaluation of 100 patients who underwent TAVI with the DFM THV. Within this study, 3 patients were at risk for receiving contrast media: 2 due to severe CKD (eGFR < 30 mL/min/1.73 m2) and 1 due to a recent hyperthyroid reaction to contrast. The valve was positioned under fluoroscopic and transesophageal guidance without aortography during either positioning or to confirm the final position. Valve positioning was based on the optimal angiographic projection as calculated by the pre-procedural multi-slice CT scan. Precise optimization of valve position was performed to minimize transvalve gradient and aortic regurgitation. Prior to final implantation, transvalve hemodynamics were assessed invasively and by TEE. Results: The average age was 81 years. The baseline logistic EuroSCORE were 15, 18 and 24. LVEF was 33, 40, and 62%. The post procedure mean gradients were 7, 10, 11 mmHg. The final AVA by echo was 1.70, 1.40 and 1.68 cm2. Total aortic regurgitation post procedure was none or trace in all 3 patients. Total positioning and assessment of valve performance time was 4, 6, and 12 minutes, and total skin to skin procedure time were 29, 47, and 64 minutes. A 25mm valve was used in all 3. There was 100% freedom from all cause mortality at 30 days. VARC defined device success was 100% and patient safety freedom from events was 100%. One had a permanent pacemaker due to AV block. Contrast was only used to confirm successful percutaneous closure of the femoral access site. The total contrast dose was 5, 8, 12 cc. Baseline eGFR and creatinine was 28, 22, 74 mL/mn/1.73 m2 and 2.35, 2.98, and 1.03 mg/dL, respectively. Renal function was unchanged post procedure: eGFR¼25, 35, and 96 mL/mn/1.73 m2 and creatinine¼2.58, 1.99, and 1.03 mg/dL, respectively. Conclusions: The DFM THV provides the ability to perform TAVI with minimal or no contrast. The precise and predictable implantation technique can be performed with fluoro and echo guidance. TCT-751 Aortic Stenosis in the Elderly: number of TAVR candidates
TCT-749 Comparison of Area and Perimeter Derived Effective Annulus Diameter with Direct Intraoperative Sizing Won-Keun Kim1, Helge Moellmann1, Andreas Rolf1, Christoph Liebetrau1, Johannes Blumenstein1, Arnaud Van Linden1, Christian W. Hamm2, Thomas Walther2, Joerg Kempfert2 1 Kerckhoff Heart Center, Bad Nauheim, Germany, 2Kerckhhoff Heart Center, Bad Nauheim, Germany Background: Accurate sizing of the aortic annulus is an important premise for successful Transcatheter aortic valve implantation (TAVI). Multislice computed tomography (MSCT) may have advantages over other imaging modalities, but there is uncertainty whether 1) measurements should be performed in systole or diastole and 2) if calculation of the effective annulus diameter should be based on area or
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Ruben L. J. Osnabrugge1, Darren Mylotte2, Stuart J. Head1, Nicolas M Van Mieghem3, Vuyisile T. Nkomo4, Corinne Le Reun5, Ad J. Bogers1, Nicolo Piazza6, A. Pieter Kappetein3 1 Erasmus University Medical Center, Rotterdam, Netherlands, 2McGill University Health Center, Royal Victoria Hospital, Montreal, Quebec, 3Erasmus MC, Rotterdam, Netherlands, 4Mayo Clinic, Rochester, MN, 5Biostatistician, Carrigaline, Ireland, 6 McGill University Health Center, Royal Victoria Hospital, Montreal, Canada Background: Severe AS is a leading cause of morbidity and mortality in elderly.A proportion of patients is now considered for transcatheter aortic valve replacement (TAVR).We i) performed a meta-analysis on the prevalence of AS in the elderly and ii) systematically estimated the number of candidates for TAVR. Methods: A systematic search was conducted in multiple databases and prevalence rates of patients (>75 years) were pooled.A model was based on a second systematic
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TCT Abstracts/POSTER/Aortic Valve Disease and Treatment