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Femoral Artery Anatomy: A Simple Strategy to Minimise Access-site Complications
308 Expected Survival and Value of Transcatheter Aortic Valve Implantation (TAVI) Versus Medical Therapy in Patients with Severe Aortic Stenosis (AS) Based on the Flinders Medical Centre (FMC) Comparative Dataset R. Prakash 1,∗ , D. Chew 1 , A. Sinhal 1 , M. Horsfall 1 , C. Green 1 , D. Makoy 1 , J. Bennetts 2 , A. Markwick 1 , J. Judd 1 , K. Waddell-Smith 1 , Y. Wong 1 1 Department of Cardiology, Flinders Medical Centre, Australia 2 Department of Cardiothoracic Surgery, Flinders Medical Cen-
tre, Australia Background: TAVI is a rapidly emerging modality for aortic valve replacement among the elderly with significant comorbidities. Its high cost remains a considerable limitation. Objective: The impact of patient’s expected survival on the economic value of TAVI was examined. Methods: Patients with severe AS were identified from the FMC echocardiographic database excluding known dementia, CVA, malignancies and prior valve surgery. Survival status and death were determined by clinical followup and interrogation of state-based clinical records repository. Survival beyond observed data were calculated using a Royston-Parmar model adjusted for age, renal impairment, Charlson index and LV function. Predetermined hospital costs, prosthesis, ICU, ward stay, investigations and recurrent CCF admissions were used. Estimates of cost effectiveness were calculated by differential survival and costs between TAVI patients and medically managed patients throughout four years using the Monte-Carlo simulation. Results: 538 patients with severe AS were identified. Fifty-six patients underwent TAVI in FMC. Median age was 85.25 years (i.q.r. 80.0–90.0 years). Unadjusted hazard ratio with TAVI (0.46, 95% CI 0.24–0.89, p = 0.022) was greater than observed in PARTNERS (HR, 0.55) but this benefit diminished after adjusting for comorbidities, (0.64, 95% CI 0.31–1.35, p = NS). Estimated cost for TAVI in the first year was ∼$80,000. Estimated cost per life saved over four years was $71,788 (±$50,891). Conclusion: Current costing suggests the expected survival of patients independent of severe AS needs to exceed four years for TAVI to be economically attractive when considering survival alone. Quality of life considered, this survival threshold may be shortened. doi:10.1016/j.hlc.2011.05.311 309 Femoral Access PCI has Very Low Bleeding Rates when Performed by Experienced Operators using Meticulous Technique J. Chandrasekhar ∗ , M. Pitney The Sutherland Hospital, Sydney, NSW, Australia Introduction: Recent trends towards the use of newer antithrombotics (Bivalirudin) or different access sites
Abstracts CSANZ Abstracts 2011
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(radial) are predicated on the supposition that the conventional technique (femoral access with unfractionated heparin) has high complication rates. Published series report major bleeding rates of approximately 5–20% when the femoral technique is used. Aims: The aim of the single centre audit was to examine the rate of major bleeding when PCI was performed using meticulous femoral technique (access site fluoroscopy, aggressive hypertension control) by operators experienced in femoral puncture and use of closure devices. Methods: From January 2008 to December 2010, 1004 consecutive patients undergoing femoral PCI by experienced operators were reviewed. Majority patients were in the age group of 50–80 years and 75% were male. Of the group, 48% had acute coronary syndromes and GP2b3a was used in 42%. Unfractionated heparin dosage was typically > 7000 units and most had PCI via 7 F sheaths. Results: Bleeding was considerably lower than expected. There were only six retroperitoneal bleeds (0.6%) and two extensive groin haematomas requiring transfusion (0.2%). No patients required surgical intervention. The overall major bleeding rate was 0.8%. Conclusions: Femoral access bleeding rates can be <1% when performed carefully, even with 7F sheaths, unfractionated heparin and considerable use of 2B3A. Rather than abandoning the femoral approach, operators should consider refining the femoral technique. doi:10.1016/j.hlc.2011.05.312 310 Femoral Artery Anatomy: A Simple Strategy to Minimise Access-site Complications B. Dundon ∗ , A. Hutchison, Y. Malaiapan, R. Gooley, J. Lipshutz, R. Harper, I. Meredith MonashHeart and Monash Cardiovascular Research Centre, Southern Clinical School, Monash University, Australia Background: Bleeding following percutaneous coronary procedures is recognised as a major contributor to adverse outcomes, particularly in cases utilising femoral artery access. This study evaluated femoral artery anatomical variability, to determine whether pre-puncture fluoroscopy assisted in the cannulation of the common femoral artery adjacent to the femoral head. Methods: Standardised femoral angiography was performed on consecutive patients undergoing coronary angiography at our institution. Offline QCA analysis was performed to determine the relationship between femoral artery anatomy and the femoral head. Results: In 120 patients, the iliac artery transition occurred adjacent the femoral head in 98.1% of patients (10.1 ± 5.5 mm from superior surface of femoral head). The femoral artery bifurcated adjacent the femoral head in 34.0% (2.3 ± 8.5 mm inferior to inferior edge of femoral head). The “optimal safety zone” (common femoral artery overlying femoral head) was 22.4 ± 6.1 mm in length, located predominantly adjacent the inferior half of the femoral head. Utilising pre-puncture fluoroscopy, a sys-
ABSTRACTS
Heart, Lung and Circulation 2011;20S:S1–S155
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Abstracts CSANZ Abstracts 2011
ABSTRACTS
tematic effort to achieve femoral artery cannulation adjacent to the inferior half of the femoral head resulted in common femoral access in 85.7% of cases and access adjacent the femoral head in 100%. Uncomplicated iliac artery cannulation occurred in 4.4% of cases with this strategy. Conclusion: Common femoral access can be achieved frequently utilising pre-puncture fluoroscopy. The iliac artery commences adjacent the superior femoral head in the majority of patients. Cannulation adjacent the superior half of the femoral head may thus be associated with a greater risk of retroperitoneal haemorrhage. We propose pre-puncture fluoroscopy as a new standard of care. doi:10.1016/j.hlc.2011.05.313 311 Femoral Versus Radial Coronary Angiography—An Audit From the Gold Coast Hospital A. Safaa ∗ , R. Markham, R. Jayasinghe, M. Trikilis Gold Coast Hospital, Australia Background: The Gold Coast hospital interventionists have recently started performing more coronary angiographies via radial approach given its presumed fewer complications rate compared to femoral approach. Objective: To compare the rate of complications and procedure and radiation exposure times between the radial and femoral approaches for coronary angiography performed at our institution, in an attempt to establish a baseline reference for future re-audits. Methods: A cohort of patients that underwent both elective and emergent coronary angiography from January 1st 2010 until July 1st 2010 was selected for this study. A total of 73 patients underwent a radial approach while 380 patients underwent a femoral approach, of which, 73 were randomly selected as a cohort for comparison. We performed a retrospective chart review to assess variables. Results: There was no statistically significant difference in procedure time or radiation dose between the two groups, with a trend that favours the femoral approach in these variables. In the femoral group there were three unsuccessful catheterisations that were converted to radial approach, and one with a small groin hematoma. In the radial group there were five unsuccessful catheterisations that were converted to femoral approach, and one with a small hematoma at the wrist. The odds ratio for complications between the radial versus femoral catheterisation was 1.54 (95% confidence interval [CI] 0.4–5.7). Conclusion: Coronary angiographies performed at the Gold Coast hospital via radial and femoral approaches had a comparable rate of complications, procedure time and radiation dose exposure. This is a continuous learning curve, and the operators’ competency in radial approach is expected to improve with more practice. doi:10.1016/j.hlc.2011.05.314
Heart, Lung and Circulation 2011;20S:S1–S155
312 First 12 Months Experience and Clinical Outcomes after Watchman® Left Atrial Appendage Occlusion Procedure: Case Series in a Single Centre J. Humphries ∗ , K. Phillips Heart Care Partners, Australia Background: Left atrial appendage (LAA) occluder devices are now an alternative for patients with nonvalvular atrial fibrillation (AF) who are unable to, or choose not to, take warfarin anticoagulation therapy. We describe the largest Australian single centre experience and outcomes for patients post Watchman® device implantation. Results: Thirteen patients aged 65.3 ± 7.36 years (CHADS2 score 2.15 ± 0.89) underwent successful implantation of a Watchman® LAA occluder device in our centre. The mean follow up period was 10.3 ± 5.1 months (range 2–16 months). Two of the patients had permanent AF, and the remaining 11 patients had previous (5/11) or concomitant pulmonary vein isolation (PVI) (6/11). Post implant transoesophageal echocardiogram (TOE) was performed at six weeks, six months and 12 months. At the time of follow up, all patients were off warfarin therapy (7/11 patients ceased at six weeks post implant, and the remaining 6/11 who had concomitant PVI ceased at three months), 11/13 were in sinus rhythm and there had been no adverse events. At implant, 6/13 patients had a small peri-device leak detected on colour flow Doppler by transoesophageal echocardiogram (TOE) of less than 3 mm. At six week follow up TOE, five patients had a residual peri-device leak, all having resolved by the six month follow-up TOE. All devices were well seated, and only 2/13 patients had a small residual atrial septal shunt at six week follow up TOE. Conclusions: In our initial experience, Watchman® device implantation is a safe procedure with good outcomes for patients, offering an acceptable alternative to warfarin therapy. doi:10.1016/j.hlc.2011.05.315 313 Fractional Flow Reserve Guided Revascularisation—The MonashHEART Experience M. Leung ∗ , B. Ko, S. Seneviratne, P. See, J. Cameron, Y. Malaiapan, I. Meredith MonashHEART and Monash Cardiovascular Research Centre, Southern Clinical School, Monash University, Melbourne, Australia Introduction: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) confers symptomatic, prognostic and cost benefit. Its comparison to standard angiography-guided PCI in determining stenosis significance and healthcare cost in Australia is unknown. Methods: Comparison of management and cost was performed between actual FFR-guided strategy (FFRstrat) and hypothetical strategy formulated by an independent
tre, Australia Background: TAVI is a rapidly emerging modality for aortic valve replacement among the elderly with significant comorbidities. Its high cost remains a considerable limitation. Objective: The impact of patient’s expected survival on the economic value of TAVI was examined. Methods: Patients with severe AS were identified from the FMC echocardiographic database excluding known dementia, CVA, malignancies and prior valve surgery. Survival status and death were determined by clinical followup and interrogation of state-based clinical records repository. Survival beyond observed data were calculated using a Royston-Parmar model adjusted for age, renal impairment, Charlson index and LV function. Predetermined hospital costs, prosthesis, ICU, ward stay, investigations and recurrent CCF admissions were used. Estimates of cost effectiveness were calculated by differential survival and costs between TAVI patients and medically managed patients throughout four years using the Monte-Carlo simulation. Results: 538 patients with severe AS were identified. Fifty-six patients underwent TAVI in FMC. Median age was 85.25 years (i.q.r. 80.0–90.0 years). Unadjusted hazard ratio with TAVI (0.46, 95% CI 0.24–0.89, p = 0.022) was greater than observed in PARTNERS (HR, 0.55) but this benefit diminished after adjusting for comorbidities, (0.64, 95% CI 0.31–1.35, p = NS). Estimated cost for TAVI in the first year was ∼$80,000. Estimated cost per life saved over four years was $71,788 (±$50,891). Conclusion: Current costing suggests the expected survival of patients independent of severe AS needs to exceed four years for TAVI to be economically attractive when considering survival alone. Quality of life considered, this survival threshold may be shortened. doi:10.1016/j.hlc.2011.05.311 309 Femoral Access PCI has Very Low Bleeding Rates when Performed by Experienced Operators using Meticulous Technique J. Chandrasekhar ∗ , M. Pitney The Sutherland Hospital, Sydney, NSW, Australia Introduction: Recent trends towards the use of newer antithrombotics (Bivalirudin) or different access sites
Abstracts CSANZ Abstracts 2011
S125
(radial) are predicated on the supposition that the conventional technique (femoral access with unfractionated heparin) has high complication rates. Published series report major bleeding rates of approximately 5–20% when the femoral technique is used. Aims: The aim of the single centre audit was to examine the rate of major bleeding when PCI was performed using meticulous femoral technique (access site fluoroscopy, aggressive hypertension control) by operators experienced in femoral puncture and use of closure devices. Methods: From January 2008 to December 2010, 1004 consecutive patients undergoing femoral PCI by experienced operators were reviewed. Majority patients were in the age group of 50–80 years and 75% were male. Of the group, 48% had acute coronary syndromes and GP2b3a was used in 42%. Unfractionated heparin dosage was typically > 7000 units and most had PCI via 7 F sheaths. Results: Bleeding was considerably lower than expected. There were only six retroperitoneal bleeds (0.6%) and two extensive groin haematomas requiring transfusion (0.2%). No patients required surgical intervention. The overall major bleeding rate was 0.8%. Conclusions: Femoral access bleeding rates can be <1% when performed carefully, even with 7F sheaths, unfractionated heparin and considerable use of 2B3A. Rather than abandoning the femoral approach, operators should consider refining the femoral technique. doi:10.1016/j.hlc.2011.05.312 310 Femoral Artery Anatomy: A Simple Strategy to Minimise Access-site Complications B. Dundon ∗ , A. Hutchison, Y. Malaiapan, R. Gooley, J. Lipshutz, R. Harper, I. Meredith MonashHeart and Monash Cardiovascular Research Centre, Southern Clinical School, Monash University, Australia Background: Bleeding following percutaneous coronary procedures is recognised as a major contributor to adverse outcomes, particularly in cases utilising femoral artery access. This study evaluated femoral artery anatomical variability, to determine whether pre-puncture fluoroscopy assisted in the cannulation of the common femoral artery adjacent to the femoral head. Methods: Standardised femoral angiography was performed on consecutive patients undergoing coronary angiography at our institution. Offline QCA analysis was performed to determine the relationship between femoral artery anatomy and the femoral head. Results: In 120 patients, the iliac artery transition occurred adjacent the femoral head in 98.1% of patients (10.1 ± 5.5 mm from superior surface of femoral head). The femoral artery bifurcated adjacent the femoral head in 34.0% (2.3 ± 8.5 mm inferior to inferior edge of femoral head). The “optimal safety zone” (common femoral artery overlying femoral head) was 22.4 ± 6.1 mm in length, located predominantly adjacent the inferior half of the femoral head. Utilising pre-puncture fluoroscopy, a sys-
ABSTRACTS
Heart, Lung and Circulation 2011;20S:S1–S155
S126
Abstracts CSANZ Abstracts 2011
ABSTRACTS
tematic effort to achieve femoral artery cannulation adjacent to the inferior half of the femoral head resulted in common femoral access in 85.7% of cases and access adjacent the femoral head in 100%. Uncomplicated iliac artery cannulation occurred in 4.4% of cases with this strategy. Conclusion: Common femoral access can be achieved frequently utilising pre-puncture fluoroscopy. The iliac artery commences adjacent the superior femoral head in the majority of patients. Cannulation adjacent the superior half of the femoral head may thus be associated with a greater risk of retroperitoneal haemorrhage. We propose pre-puncture fluoroscopy as a new standard of care. doi:10.1016/j.hlc.2011.05.313 311 Femoral Versus Radial Coronary Angiography—An Audit From the Gold Coast Hospital A. Safaa ∗ , R. Markham, R. Jayasinghe, M. Trikilis Gold Coast Hospital, Australia Background: The Gold Coast hospital interventionists have recently started performing more coronary angiographies via radial approach given its presumed fewer complications rate compared to femoral approach. Objective: To compare the rate of complications and procedure and radiation exposure times between the radial and femoral approaches for coronary angiography performed at our institution, in an attempt to establish a baseline reference for future re-audits. Methods: A cohort of patients that underwent both elective and emergent coronary angiography from January 1st 2010 until July 1st 2010 was selected for this study. A total of 73 patients underwent a radial approach while 380 patients underwent a femoral approach, of which, 73 were randomly selected as a cohort for comparison. We performed a retrospective chart review to assess variables. Results: There was no statistically significant difference in procedure time or radiation dose between the two groups, with a trend that favours the femoral approach in these variables. In the femoral group there were three unsuccessful catheterisations that were converted to radial approach, and one with a small groin hematoma. In the radial group there were five unsuccessful catheterisations that were converted to femoral approach, and one with a small hematoma at the wrist. The odds ratio for complications between the radial versus femoral catheterisation was 1.54 (95% confidence interval [CI] 0.4–5.7). Conclusion: Coronary angiographies performed at the Gold Coast hospital via radial and femoral approaches had a comparable rate of complications, procedure time and radiation dose exposure. This is a continuous learning curve, and the operators’ competency in radial approach is expected to improve with more practice. doi:10.1016/j.hlc.2011.05.314
Heart, Lung and Circulation 2011;20S:S1–S155
312 First 12 Months Experience and Clinical Outcomes after Watchman® Left Atrial Appendage Occlusion Procedure: Case Series in a Single Centre J. Humphries ∗ , K. Phillips Heart Care Partners, Australia Background: Left atrial appendage (LAA) occluder devices are now an alternative for patients with nonvalvular atrial fibrillation (AF) who are unable to, or choose not to, take warfarin anticoagulation therapy. We describe the largest Australian single centre experience and outcomes for patients post Watchman® device implantation. Results: Thirteen patients aged 65.3 ± 7.36 years (CHADS2 score 2.15 ± 0.89) underwent successful implantation of a Watchman® LAA occluder device in our centre. The mean follow up period was 10.3 ± 5.1 months (range 2–16 months). Two of the patients had permanent AF, and the remaining 11 patients had previous (5/11) or concomitant pulmonary vein isolation (PVI) (6/11). Post implant transoesophageal echocardiogram (TOE) was performed at six weeks, six months and 12 months. At the time of follow up, all patients were off warfarin therapy (7/11 patients ceased at six weeks post implant, and the remaining 6/11 who had concomitant PVI ceased at three months), 11/13 were in sinus rhythm and there had been no adverse events. At implant, 6/13 patients had a small peri-device leak detected on colour flow Doppler by transoesophageal echocardiogram (TOE) of less than 3 mm. At six week follow up TOE, five patients had a residual peri-device leak, all having resolved by the six month follow-up TOE. All devices were well seated, and only 2/13 patients had a small residual atrial septal shunt at six week follow up TOE. Conclusions: In our initial experience, Watchman® device implantation is a safe procedure with good outcomes for patients, offering an acceptable alternative to warfarin therapy. doi:10.1016/j.hlc.2011.05.315 313 Fractional Flow Reserve Guided Revascularisation—The MonashHEART Experience M. Leung ∗ , B. Ko, S. Seneviratne, P. See, J. Cameron, Y. Malaiapan, I. Meredith MonashHEART and Monash Cardiovascular Research Centre, Southern Clinical School, Monash University, Melbourne, Australia Introduction: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) confers symptomatic, prognostic and cost benefit. Its comparison to standard angiography-guided PCI in determining stenosis significance and healthcare cost in Australia is unknown. Methods: Comparison of management and cost was performed between actual FFR-guided strategy (FFRstrat) and hypothetical strategy formulated by an independent