- Email: [email protected]
PROCEDURAL AND CLINICAL OUTCOMES AFTER TRANSCATHETER IMPACT OF THE LEARNING CURVE ON PRAORTIC VALVE IMPLANTATION
Abstracts
angiography. Of these, assessments of the renal arteries were performed in 26 of the 27 patients, and assessments of the iliac arteries were performed in 19 of the 27 patients. Renal FMD was identified on catheter angiography in 17/26 patients, but was only identified on CT angiography in 4/26 patients. Iliac FMD was identified in 13/19 patients with catheter angiography, but was only identified in 1/19 patients on CT angiography. Of the 23/27 patients with extracardiac (renal or iliac) FMD identified on catheter angiography, only 4 of these patients was found to have FMD on CT angiography (sensitivity of 17.4%). CONCLUSION: Although CT angiography is noninvasive, it was poorly sensitive in diagnosing renal or iliac FMD when compared to the gold-standard catheter angiography. Further prospective studies should be performed to confirm our findings. 196 QUALITY OF LIFE AND FRAILTY FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION P Gouda, C Paterson, S Meyer, M Shanks, C Butler, D Taylor, B Tyrrell, RC Welsh Edmonton, Alberta BACKGROUND:
Transcather aortic valve implantation (TAVI) is an established alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and increased surgical risk. Frailty is a critical clinical metric that heart teams assess to select TAVI over SAVR. To date there has been limited data assessing frailty assessed sequentially over time in TAVI patients and the relationship of frailty to quality of life measurements. METHODS/RESULTS: From June 2012 to June 2015, 159 consecutive patients underwent TAVI. Of these, 65 had undergone sequential frailty testing and completed quality of life questionnaires pre-TAVI and one-month post-TAVI. In this cohort, the mean age was 85.5 +/- 6.25 years, 56.9% were male and mean body mass index was 27.8+/- 5.0. Mean baseline ejection fraction (EF) was 55.4% +/- 10.3 and mean post-TAVI EF was 57.9% +/- 6.8. At baseline participants reported an activities of daily living disability mean score of 3.22 +/- 2.1, with a mean improvement of 1.0 +/- 2.5 at one month. Participants scored their overall baseline wellbeing at a mean of 58.8% +/19.2, which increased to 71.4% +/- 14.8 at one month. Using the Minnesota Quality of Life questionnaire, patients reported a baseline mean score of 52.3% +/- 23.0 for physical components and 13.0% +/- 18.4 for emotional components, which improved to 21.2% +/- 18.8 and 2.6% +/- 6.0 respectively. Frailty measured by hand grip strength did not improve with a mean of 24.5 +/- 7.8 at baseline, which decreased to 23.7 +/- 7.3 at on month. The walk test had modest improvement with 50.0% passing the walk test at baseline 50.0% and 55.6% at one month. CONCLUSION: Consistent with known data, patients who have undergone TAVI report consistent improvements in quality of life one-month post-TAVI using a variety of instruments to evaluate quality of life. However, measurements of frailty using handgrip and walk test as a surrogates for frailty, had no significant short-term improvements in frailty. Understanding
S179
frailty and its impact on patient selection and outcomes is critical and warrants further consideration. 197 TRANSFEMORAL ACURATE-NEOTM SELFEXPANDING TRANSCATHETER AORTIC VALVE IMPLANTATION: FIRST NORTH AMERICAN EXPERIENCE R Bagur, PJ Teefy, B Kiaii, P Diamantouros, MW Chu London, Ontario BACKGROUND:
Transcatheter aortic valve implantation (TAVI) has become a therapeutic alternative for patients presenting with severe symptomatic aortic stenosis and considered at highsurgical risk. Paravalvular leak (PVL), conduction disorders and coronary obstruction remain unresolved procedure-related complications. The aim of this manuscript was to report the first North American experience with the ACURATE-neoTM aortic bioprosthesis and its ACURATE-TFTM delivery system (Symetis S.A., Ecublens, Switzerland). TM METHODS: Transfemoral ACURATE-neo aortic valve implantation was performed in 17 patients. Clinical and echocardiographic assessment was performed at baseline, post-procedure and at least 30 days. Outcomes were assessed according to valvular academic research consortium (VARC-2) criteria. RESULTS: The mean age was 83.57.1 years with a mean logistic-EuroSCORE-II of 5.13.0% and Society of Thoracic Surgeons score of 4.92.3%. Device success was achieved in all patients. Notably, the mean distance between the aortic-annulus and the left main coronary artery ostium was 13.42.7 mm, and 8 (47%) patients had <12 mm. At 30-day, there were no deaths, conversions to surgery or major procedure-related complications. New-pacemaker implantation was required in 6.3% of patients. ACURATE-neoTMimplantation resulted in a significant reduction in mean transvalvular gradient (51.116.5 mmHg to 10.45.8 mmHg, P<0.0001) and increase in effective-orifice area (0.640.15 cm2 to 1.780.38 cm2, P<0.0001) at hospitaldischarge. Paravalvular-leak was absent in 4 patients, trace in 6 patients and mild in 7 patients. Hospital discharge occurred at a mean of 7.14.8 days, and all patients were in NYHA class I-II at a mean follow-up of 6.02.3 months. CONCLUSION: The present initial North American experience shows that the ACURATE-neoTM aortic bioprosthesis was safely and successfully implanted by transfemoral approach. The special design of this newer-generation device affords a stable and predictable implantation, representing a reasonable alternative to reduce the risk of coronary obstruction while achieving optimal hemodynamic performance with a relatively low rate of PPI. 198 PROCEDURAL AND CLINICAL OUTCOMES AFTER TRANSCATHETER IMPACT OF THE LEARNING CURVE ON PRAORTIC VALVE IMPLANTATION Z Frikha, A El hammiri, C Naim, JB Masson, JF Gobeil, LM Stevens, N Noiseux, J Potvin Montréal, Québec
S180 BACKGROUND:
Transcatheter aortic valve implantation (TAVI) is the new standard of care for selected patients with symptomatic severe aortic stenosis who are inoperable or at high risk for surgical aortic valve replacement. Following proper training, the Heart Team involved in TAVI procedures acquires experience in patient selection and procedural aspects at a pace that may vary according to the program volume. Our aim was to investigate the effect of the learning curve on patient selection and procedural and clinical outcomes in an intermediate volume Canadian TAVI center. METHODS: Monocentric, observational, retrospective analysis of the first 180 patients treated between January 2010 and March 2016 in an intermediate volume TAVI center. Patients were divided into tertiles (n ¼ 60), according to the procedure date. Outcomes were defined according to Valve Academic Research Consortium-2 (VARC-2) criteria. RESULTS: Baseline characteristics and comorbidities were similar between the groups. The Edwards valves (SAPIENÔ, SAPIEN XTÔ or S3Ô) were implanted in 87% of the cohort and the LotusÔ valve in 13% (all in the third tertile). The median age of the patients was 82 years (range: 45 to 94 years). A gradual decrease in STS Score was observed over time: 6.893.32 vs 5.173.39 vs 4.053.26; p<0.01. Procedural success remained high (95% vs 96.7% vs 100%; p¼0.23) and there was no significant difference in procedure duration (74.919.1 vs 70.724.0 vs 76.830.4 minutes; p ¼ 0.43) between tertiles. A significant decrease in the occurence of moderate or severe aortic regurgitation (19.8 % vs 26.3% vs 3.3 %, p¼0.001) and major bleeding (21.7% vs 10.0% vs 6.7%, p¼0.03) were seen across the 3 tertiles. No significant decrease in duration of hospitalisation between groups was observed (7 days; IQR: 4 to 13 vs 6 days; IQR: 3 to 14 vs 5 days; IQR: 3 to 8; p¼0,15). In-hospital stroke occurred in 2.8% of the cohort (5.0% vs 1.7% vs 1.7%, p¼0.46). In-hospital infections occurred in 10 patients (5.6% of cohort) and were largely seen in the first tertile. The overall need for a new permanent pacemaker was 11.7 % (13.3% vs. 5% vs 16.7%, p¼0.12). In-hospital mortality decreased over the study period from 8.3% to 0% (p¼0.006). CONCLUSION: In our TAVI cohort, outcomes improved with experience, better patient selection and introduction of nextgeneration devices. Overall results and complication rates in an intermediate volume TAVI center are similar to those reported by high volume centers. 199 RENAL PROTECTION IN CORONARY INTERVENTION USING THE RENAL GUARD SYSTEM PROTOCOL: FINDINGS OF UK REGISTRY AD Premawardhana, R Davies, A Choudhury Cardiff, Wales BACKGROUND:
Contrast-induced nephropathy (CIN) is a leading cause of acute renal failure and is a recognised complication of coronary catheterization. It is associated with significant morbidity and mortality, extended length of hospital stay and persistent worsening of renal function, with
Canadian Journal of Cardiology Volume 32 2016
considerable resulting healthcare costs. Pre-existent chronic kidney disease (CKD) is the most important pre-procedural risk factor for CIN and is increasingly prevalent in our patient population. A number of approaches have been trialled to moderate this risk with mixed results. Recent studies show success with inducing vigorous diuresis whilst maintaining euvolaemia with intravenous volume loading. The Renal Guard System (RGS) has been developed to achieve this showing much promise in reducing the risk of CIN in RCTs. METHODS: The RGS consists of: Initiating dieresis with a small intravenous dose of furosemide and saline bolus; A digital scale for measurement of urinary output (UO); A saline pump automatically adjusting the input rate to match the UO, achieving exact euvolaemia. We aimed to generate a prospective UK registry database to evaluate the efficacy of the RGS in high risk patients undergoing PCI. UHW patient data was collected from notes, clinical portal and the British Cardiovascular Intervention Society database. For other UK centres data was obtained from ‘Aquilant Interventional’ - the company distributing RGS in UK. RESULTS: 38 patients (7 at UHW) underwent PCI based on the RGS protocol across 12 centres. 26% of the patients had CTO PCI while the rest underwent multi-vessel PCI. Mean contrast volume used was 202ml. Mean pre-procedure eGFR was 36.2 and mean eGFR 72hrs post-procedure was 38.6. No patients developed CIN or pulmonary oedema. In the 7 patients at UHW the mean Mehran risk score (MRS) was 13 with a predicted risk of CIN being 26%. Mean UO during PCI was 950 ml and in the 6 hours post PCI was 1796 ml. The mean inpatient stay was 2.5 days. CONCLUSIONS: UK registry data suggests the RGS protocol can significantly reduce CIN in high risk patients undergoing complex PCI. Patients with no rise in creatinine are now being discharged after 48 hours rather than the customary 72 hours. This reduction in inpatient stay along with the reduction in CIN rates can yield major healthcare cost benefits. High risk groups of patients likely to benefit from RGS are those with CKD scheduled for a procedure requiring significant contrast volume such as complex PCIs, pre TAVI diagnostics and CRT.
angiography. Of these, assessments of the renal arteries were performed in 26 of the 27 patients, and assessments of the iliac arteries were performed in 19 of the 27 patients. Renal FMD was identified on catheter angiography in 17/26 patients, but was only identified on CT angiography in 4/26 patients. Iliac FMD was identified in 13/19 patients with catheter angiography, but was only identified in 1/19 patients on CT angiography. Of the 23/27 patients with extracardiac (renal or iliac) FMD identified on catheter angiography, only 4 of these patients was found to have FMD on CT angiography (sensitivity of 17.4%). CONCLUSION: Although CT angiography is noninvasive, it was poorly sensitive in diagnosing renal or iliac FMD when compared to the gold-standard catheter angiography. Further prospective studies should be performed to confirm our findings. 196 QUALITY OF LIFE AND FRAILTY FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION P Gouda, C Paterson, S Meyer, M Shanks, C Butler, D Taylor, B Tyrrell, RC Welsh Edmonton, Alberta BACKGROUND:
Transcather aortic valve implantation (TAVI) is an established alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and increased surgical risk. Frailty is a critical clinical metric that heart teams assess to select TAVI over SAVR. To date there has been limited data assessing frailty assessed sequentially over time in TAVI patients and the relationship of frailty to quality of life measurements. METHODS/RESULTS: From June 2012 to June 2015, 159 consecutive patients underwent TAVI. Of these, 65 had undergone sequential frailty testing and completed quality of life questionnaires pre-TAVI and one-month post-TAVI. In this cohort, the mean age was 85.5 +/- 6.25 years, 56.9% were male and mean body mass index was 27.8+/- 5.0. Mean baseline ejection fraction (EF) was 55.4% +/- 10.3 and mean post-TAVI EF was 57.9% +/- 6.8. At baseline participants reported an activities of daily living disability mean score of 3.22 +/- 2.1, with a mean improvement of 1.0 +/- 2.5 at one month. Participants scored their overall baseline wellbeing at a mean of 58.8% +/19.2, which increased to 71.4% +/- 14.8 at one month. Using the Minnesota Quality of Life questionnaire, patients reported a baseline mean score of 52.3% +/- 23.0 for physical components and 13.0% +/- 18.4 for emotional components, which improved to 21.2% +/- 18.8 and 2.6% +/- 6.0 respectively. Frailty measured by hand grip strength did not improve with a mean of 24.5 +/- 7.8 at baseline, which decreased to 23.7 +/- 7.3 at on month. The walk test had modest improvement with 50.0% passing the walk test at baseline 50.0% and 55.6% at one month. CONCLUSION: Consistent with known data, patients who have undergone TAVI report consistent improvements in quality of life one-month post-TAVI using a variety of instruments to evaluate quality of life. However, measurements of frailty using handgrip and walk test as a surrogates for frailty, had no significant short-term improvements in frailty. Understanding
S179
frailty and its impact on patient selection and outcomes is critical and warrants further consideration. 197 TRANSFEMORAL ACURATE-NEOTM SELFEXPANDING TRANSCATHETER AORTIC VALVE IMPLANTATION: FIRST NORTH AMERICAN EXPERIENCE R Bagur, PJ Teefy, B Kiaii, P Diamantouros, MW Chu London, Ontario BACKGROUND:
Transcatheter aortic valve implantation (TAVI) has become a therapeutic alternative for patients presenting with severe symptomatic aortic stenosis and considered at highsurgical risk. Paravalvular leak (PVL), conduction disorders and coronary obstruction remain unresolved procedure-related complications. The aim of this manuscript was to report the first North American experience with the ACURATE-neoTM aortic bioprosthesis and its ACURATE-TFTM delivery system (Symetis S.A., Ecublens, Switzerland). TM METHODS: Transfemoral ACURATE-neo aortic valve implantation was performed in 17 patients. Clinical and echocardiographic assessment was performed at baseline, post-procedure and at least 30 days. Outcomes were assessed according to valvular academic research consortium (VARC-2) criteria. RESULTS: The mean age was 83.57.1 years with a mean logistic-EuroSCORE-II of 5.13.0% and Society of Thoracic Surgeons score of 4.92.3%. Device success was achieved in all patients. Notably, the mean distance between the aortic-annulus and the left main coronary artery ostium was 13.42.7 mm, and 8 (47%) patients had <12 mm. At 30-day, there were no deaths, conversions to surgery or major procedure-related complications. New-pacemaker implantation was required in 6.3% of patients. ACURATE-neoTMimplantation resulted in a significant reduction in mean transvalvular gradient (51.116.5 mmHg to 10.45.8 mmHg, P<0.0001) and increase in effective-orifice area (0.640.15 cm2 to 1.780.38 cm2, P<0.0001) at hospitaldischarge. Paravalvular-leak was absent in 4 patients, trace in 6 patients and mild in 7 patients. Hospital discharge occurred at a mean of 7.14.8 days, and all patients were in NYHA class I-II at a mean follow-up of 6.02.3 months. CONCLUSION: The present initial North American experience shows that the ACURATE-neoTM aortic bioprosthesis was safely and successfully implanted by transfemoral approach. The special design of this newer-generation device affords a stable and predictable implantation, representing a reasonable alternative to reduce the risk of coronary obstruction while achieving optimal hemodynamic performance with a relatively low rate of PPI. 198 PROCEDURAL AND CLINICAL OUTCOMES AFTER TRANSCATHETER IMPACT OF THE LEARNING CURVE ON PRAORTIC VALVE IMPLANTATION Z Frikha, A El hammiri, C Naim, JB Masson, JF Gobeil, LM Stevens, N Noiseux, J Potvin Montréal, Québec
S180 BACKGROUND:
Transcatheter aortic valve implantation (TAVI) is the new standard of care for selected patients with symptomatic severe aortic stenosis who are inoperable or at high risk for surgical aortic valve replacement. Following proper training, the Heart Team involved in TAVI procedures acquires experience in patient selection and procedural aspects at a pace that may vary according to the program volume. Our aim was to investigate the effect of the learning curve on patient selection and procedural and clinical outcomes in an intermediate volume Canadian TAVI center. METHODS: Monocentric, observational, retrospective analysis of the first 180 patients treated between January 2010 and March 2016 in an intermediate volume TAVI center. Patients were divided into tertiles (n ¼ 60), according to the procedure date. Outcomes were defined according to Valve Academic Research Consortium-2 (VARC-2) criteria. RESULTS: Baseline characteristics and comorbidities were similar between the groups. The Edwards valves (SAPIENÔ, SAPIEN XTÔ or S3Ô) were implanted in 87% of the cohort and the LotusÔ valve in 13% (all in the third tertile). The median age of the patients was 82 years (range: 45 to 94 years). A gradual decrease in STS Score was observed over time: 6.893.32 vs 5.173.39 vs 4.053.26; p<0.01. Procedural success remained high (95% vs 96.7% vs 100%; p¼0.23) and there was no significant difference in procedure duration (74.919.1 vs 70.724.0 vs 76.830.4 minutes; p ¼ 0.43) between tertiles. A significant decrease in the occurence of moderate or severe aortic regurgitation (19.8 % vs 26.3% vs 3.3 %, p¼0.001) and major bleeding (21.7% vs 10.0% vs 6.7%, p¼0.03) were seen across the 3 tertiles. No significant decrease in duration of hospitalisation between groups was observed (7 days; IQR: 4 to 13 vs 6 days; IQR: 3 to 14 vs 5 days; IQR: 3 to 8; p¼0,15). In-hospital stroke occurred in 2.8% of the cohort (5.0% vs 1.7% vs 1.7%, p¼0.46). In-hospital infections occurred in 10 patients (5.6% of cohort) and were largely seen in the first tertile. The overall need for a new permanent pacemaker was 11.7 % (13.3% vs. 5% vs 16.7%, p¼0.12). In-hospital mortality decreased over the study period from 8.3% to 0% (p¼0.006). CONCLUSION: In our TAVI cohort, outcomes improved with experience, better patient selection and introduction of nextgeneration devices. Overall results and complication rates in an intermediate volume TAVI center are similar to those reported by high volume centers. 199 RENAL PROTECTION IN CORONARY INTERVENTION USING THE RENAL GUARD SYSTEM PROTOCOL: FINDINGS OF UK REGISTRY AD Premawardhana, R Davies, A Choudhury Cardiff, Wales BACKGROUND:
Contrast-induced nephropathy (CIN) is a leading cause of acute renal failure and is a recognised complication of coronary catheterization. It is associated with significant morbidity and mortality, extended length of hospital stay and persistent worsening of renal function, with
Canadian Journal of Cardiology Volume 32 2016
considerable resulting healthcare costs. Pre-existent chronic kidney disease (CKD) is the most important pre-procedural risk factor for CIN and is increasingly prevalent in our patient population. A number of approaches have been trialled to moderate this risk with mixed results. Recent studies show success with inducing vigorous diuresis whilst maintaining euvolaemia with intravenous volume loading. The Renal Guard System (RGS) has been developed to achieve this showing much promise in reducing the risk of CIN in RCTs. METHODS: The RGS consists of: Initiating dieresis with a small intravenous dose of furosemide and saline bolus; A digital scale for measurement of urinary output (UO); A saline pump automatically adjusting the input rate to match the UO, achieving exact euvolaemia. We aimed to generate a prospective UK registry database to evaluate the efficacy of the RGS in high risk patients undergoing PCI. UHW patient data was collected from notes, clinical portal and the British Cardiovascular Intervention Society database. For other UK centres data was obtained from ‘Aquilant Interventional’ - the company distributing RGS in UK. RESULTS: 38 patients (7 at UHW) underwent PCI based on the RGS protocol across 12 centres. 26% of the patients had CTO PCI while the rest underwent multi-vessel PCI. Mean contrast volume used was 202ml. Mean pre-procedure eGFR was 36.2 and mean eGFR 72hrs post-procedure was 38.6. No patients developed CIN or pulmonary oedema. In the 7 patients at UHW the mean Mehran risk score (MRS) was 13 with a predicted risk of CIN being 26%. Mean UO during PCI was 950 ml and in the 6 hours post PCI was 1796 ml. The mean inpatient stay was 2.5 days. CONCLUSIONS: UK registry data suggests the RGS protocol can significantly reduce CIN in high risk patients undergoing complex PCI. Patients with no rise in creatinine are now being discharged after 48 hours rather than the customary 72 hours. This reduction in inpatient stay along with the reduction in CIN rates can yield major healthcare cost benefits. High risk groups of patients likely to benefit from RGS are those with CKD scheduled for a procedure requiring significant contrast volume such as complex PCIs, pre TAVI diagnostics and CRT.