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Australian and New Zealand Source Registry: Edwards Sapien Transcatheter Aortic Valve Replacement—30 Day Outcomes
S116
Abstracts CSANZ Abstracts 2011
Heart, Lung and Circulation 2011;20S:S1–S155
ABSTRACTS
286 Australian and New Zealand Source Registry: Edwards Sapien Transcatheter Aortic Valve Replacement—30 Day Outcomes D. Walters 1,∗ , A. Sinhal 2 , D. Barron 3 , S. S. Thambar 5 , G. Yong 6 , N. Jepson 7 , R. Bennetts 2 , R. Larbalestier 6 , A. Clarke 1 , P. Wolfenden 7 , A. James 5 , A. El Gamel 4 , P. Chew 2 , for the SOURCE AUS Investigators
Pasupati 4 , Bhindi 8 , J. Brady 8 , H. Jansz 3 , D.
1 The
Prince Charles Hospital, Australia Medical Centre, Australia 3 St Vincents Hospital Sydney, Australia 4 Waikato Hospital, New Zealand 5 John Hunter Hospital, Australia 6 Royal Perth Hospital, Australia 7 Prince of Wales Sydney, Australia 8 Royal North Shore Hospital, Australia 2 Flinders
Background: Transcatheter aortic valve replacement (TAVR) may be considered for those with severe aortic stenosis who are considered inoperable or at high risk for surgical replacement. We report the 30-day outcomes of the Edwards Sapien Source Registry in Australia and New Zealand. Methods: This study enrolled 133 subjects at eight centres since December 2008. Inclusion criteria included severe symptomatic aortic valve disease, symptomatic degenerative aortic stenosis (AVA ≤ 0.8 cm2 ), logistic Euroscore > 20% or STS > 10%, agreement between surgeon and cardiologist that the patient not suitable for open surgery due to high risk. Results: A total of 133 were enrolled with complete data for 99 patients consisting of 53 transfemoral (TF) and 46 transapical (TA) implants. The mean age 82.6 years (TF) and 83.6 years (TA), female 32.1% (TF) 56.5% (TA), logistic Euroscore 27.6% (TF) 30.7% (TF) with procedural success (successful implant without conversion to surgery or death) of 92.3% (TF) 87% (TA) (p = 0.384). Thirty-day outcomes were not significantly different between TF and TA implants. These included mortality of 3.8% (TF) 8.7% (TA) (p = 0.38), major adverse cardiac and cerebrovascular events 5.7% (TF) and 13.0% (TA) (p = 0.205), pacemaker 2.2% (TF) 0% (TA) (p = 0.283), and VARC major vascular complication of 6.5% (TF) 5.7% (TA) (p = 0.859). Conclusion: TAVR with the Edwards Sapien device is safe and effective therapy by TA or TF route. A high procedural success rate was achieved with an acceptable incidence of adverse events for a patient group at high risk for open surgery. doi:10.1016/j.hlc.2011.05.289
287 Balloon Aortic Valvuloplasty (BAV). Does it Have a Role in the Era of Transcatheter Aortic Valve Implantation (TAVI)? S. Pasupati ∗ , M. Liang Department of Cardiology, Waikato Hospital, Hamilton, New Zealand Background: BAV fell out of favour due to poor survival benefit, perceived procedural complexity and the need for repeat procedure in short duration. It has been used as a bridge to surgical aortic valve replacement (SAVR) or TAVI and as a palliative procedure for patients who have been declined for valve replacement. We report experience with our first 75 BAV procedures. Method: BAV procedures were done under local anaesthesia with rapid pacing. Balloon size was 100–120% of aortic annulus with Cristal balloon (Balt, Montmorency, France) used as first line. Echocardiogram was performed at 24–48 h post BAV. Results: Seventy-five procedures were done in 72 patients over 40months. Twenty-two (31%) were bridged to TAVI with five (7%) receiving SAVR. Mean age was 81 years. Mean Logistic Euroscore was 28%. Sixteen percent received a concomitant coronary intervention. Aortic mean gradient and valve area improved from 51 ± 16 mm Hg to 30 ± 10 mm Hg (p < 0.001), 0.7 ± 0.2 cm2 to 1.1 ± 0.3 cm2 (p < 0.001) respectively. Fifty-six percent of patients with impaired ejection fraction, improved post BAV (32 ± 7% to 41 ± 9%; p < 0.01). Mitral regurgitation improved in 39% by at least one grade with 56% remaining unchanged. Thirty-day complications involved 1% stroke, 4% TIA, 1% vascular injury and 3% blood transfusion. Two patients required redo BAV. Admissions in 6 months improved from 2 ± 1 to 1 ± 1 (p = 0.002). NYHA class improved from 3 ± 1 to 1 ± 1. There were no intraprocedural deaths with one and 12 month survival of 93% and 71% respectively. One-year survival for bridged procedures vs. isolated BAV was 92% and 56% respectively (p < 0.0001). Conclusion: In the era of TAVI, BAV is useful to assess LV reserve, MR improvement and over all patient well being with low procedural complications. It is a useful palliative therapy for aortic stenotic patients with no other options. doi:10.1016/j.hlc.2011.05.290 288 This abstract has been withdrawn
Abstracts CSANZ Abstracts 2011
Heart, Lung and Circulation 2011;20S:S1–S155
ABSTRACTS
286 Australian and New Zealand Source Registry: Edwards Sapien Transcatheter Aortic Valve Replacement—30 Day Outcomes D. Walters 1,∗ , A. Sinhal 2 , D. Barron 3 , S. S. Thambar 5 , G. Yong 6 , N. Jepson 7 , R. Bennetts 2 , R. Larbalestier 6 , A. Clarke 1 , P. Wolfenden 7 , A. James 5 , A. El Gamel 4 , P. Chew 2 , for the SOURCE AUS Investigators
Pasupati 4 , Bhindi 8 , J. Brady 8 , H. Jansz 3 , D.
1 The
Prince Charles Hospital, Australia Medical Centre, Australia 3 St Vincents Hospital Sydney, Australia 4 Waikato Hospital, New Zealand 5 John Hunter Hospital, Australia 6 Royal Perth Hospital, Australia 7 Prince of Wales Sydney, Australia 8 Royal North Shore Hospital, Australia 2 Flinders
Background: Transcatheter aortic valve replacement (TAVR) may be considered for those with severe aortic stenosis who are considered inoperable or at high risk for surgical replacement. We report the 30-day outcomes of the Edwards Sapien Source Registry in Australia and New Zealand. Methods: This study enrolled 133 subjects at eight centres since December 2008. Inclusion criteria included severe symptomatic aortic valve disease, symptomatic degenerative aortic stenosis (AVA ≤ 0.8 cm2 ), logistic Euroscore > 20% or STS > 10%, agreement between surgeon and cardiologist that the patient not suitable for open surgery due to high risk. Results: A total of 133 were enrolled with complete data for 99 patients consisting of 53 transfemoral (TF) and 46 transapical (TA) implants. The mean age 82.6 years (TF) and 83.6 years (TA), female 32.1% (TF) 56.5% (TA), logistic Euroscore 27.6% (TF) 30.7% (TF) with procedural success (successful implant without conversion to surgery or death) of 92.3% (TF) 87% (TA) (p = 0.384). Thirty-day outcomes were not significantly different between TF and TA implants. These included mortality of 3.8% (TF) 8.7% (TA) (p = 0.38), major adverse cardiac and cerebrovascular events 5.7% (TF) and 13.0% (TA) (p = 0.205), pacemaker 2.2% (TF) 0% (TA) (p = 0.283), and VARC major vascular complication of 6.5% (TF) 5.7% (TA) (p = 0.859). Conclusion: TAVR with the Edwards Sapien device is safe and effective therapy by TA or TF route. A high procedural success rate was achieved with an acceptable incidence of adverse events for a patient group at high risk for open surgery. doi:10.1016/j.hlc.2011.05.289
287 Balloon Aortic Valvuloplasty (BAV). Does it Have a Role in the Era of Transcatheter Aortic Valve Implantation (TAVI)? S. Pasupati ∗ , M. Liang Department of Cardiology, Waikato Hospital, Hamilton, New Zealand Background: BAV fell out of favour due to poor survival benefit, perceived procedural complexity and the need for repeat procedure in short duration. It has been used as a bridge to surgical aortic valve replacement (SAVR) or TAVI and as a palliative procedure for patients who have been declined for valve replacement. We report experience with our first 75 BAV procedures. Method: BAV procedures were done under local anaesthesia with rapid pacing. Balloon size was 100–120% of aortic annulus with Cristal balloon (Balt, Montmorency, France) used as first line. Echocardiogram was performed at 24–48 h post BAV. Results: Seventy-five procedures were done in 72 patients over 40months. Twenty-two (31%) were bridged to TAVI with five (7%) receiving SAVR. Mean age was 81 years. Mean Logistic Euroscore was 28%. Sixteen percent received a concomitant coronary intervention. Aortic mean gradient and valve area improved from 51 ± 16 mm Hg to 30 ± 10 mm Hg (p < 0.001), 0.7 ± 0.2 cm2 to 1.1 ± 0.3 cm2 (p < 0.001) respectively. Fifty-six percent of patients with impaired ejection fraction, improved post BAV (32 ± 7% to 41 ± 9%; p < 0.01). Mitral regurgitation improved in 39% by at least one grade with 56% remaining unchanged. Thirty-day complications involved 1% stroke, 4% TIA, 1% vascular injury and 3% blood transfusion. Two patients required redo BAV. Admissions in 6 months improved from 2 ± 1 to 1 ± 1 (p = 0.002). NYHA class improved from 3 ± 1 to 1 ± 1. There were no intraprocedural deaths with one and 12 month survival of 93% and 71% respectively. One-year survival for bridged procedures vs. isolated BAV was 92% and 56% respectively (p < 0.0001). Conclusion: In the era of TAVI, BAV is useful to assess LV reserve, MR improvement and over all patient well being with low procedural complications. It is a useful palliative therapy for aortic stenotic patients with no other options. doi:10.1016/j.hlc.2011.05.290 288 This abstract has been withdrawn