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CRT-800.33 Surgical versus Transcatheter Aortic Valve Replacement in Non-High Surgical Risk Severe Aortic Stenosis: A Systematic Review
JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 10, NO. 3, SUPPL S, 2017
CONCLUSION Advanced dementia is associated with increased length of ICU and hospital stay. However, the clinical significance is marginal and should not preclude the patients from therapy based on our results. Larger studies will need to be performed to assess the primary outcomes that could not be addressed in this study. CRT-800.32 Improvement in Aortic Valve Area in Aortic Stenosis Patients Using a New “Hourglass” Shaped Valvuloplasty Compared with Cylindrical Balloons Wesley Pedersen, Mason Hinke, Pau Sorajja, Aisha Ahmed, Michael Mooney, Irvin Goldberg Minneapolis Heart Institute Foundation, Minneapolis, MN Balloon (bal) aortic valvulopasty (BAV) has reemerged with transcatheter therapy. Cylindrical bal have been the device of choice despite limitations. The V8 (InterValve Inc) bal with broader segments separated by a narrowed waist is designed to permit enhanced fix and better leaflet opening without annular compromise. Reported are our findings using the V8 bal in 40 consecutive, matched patients (pts) undergoing BAV compared to a subset of 40 pts from a 403 pt BAV database using cylindrical bals. Pts were propensity matched by age, gender, left ventricular ejection fraction (LVEF) and Society of Thoracic Surgeons (STS) risk score. Endpoints included change in AVA by echo, change in aortic insufficiency (AI), new permanent pacemaker implantation (PPM) and major adverse event (MAE) which included procedural death, emergency surgery or stoke. Bal sizes for each pt were recorded. AI was quantitated numerically: 0 none to trace, 1+ mild, 2+ moderate, 3+ severe. V8 and cylindrical bal groups were similar across age, sex, STS score, LVEF and baseline AVA. The change in AVA from baseline to post procedure strongly trended in favor of V8 bal pts over cylindrical bal pts (0.29cm20.17 vs. 0.22cm 20.15; p¼0.058). Maximum bal sizes were significantly larger for V8 pts enabled by the bal shape. There were no significant differences in AI, new PPM or MAE. There was no severe AI in either group post procedure. Findings in this preliminary experience suggest an advantage for enhancing AVA when using the V8 bal. In addition, there was no increase in AI, new PPM or MAE events in comparison to the cylindrical bal.
S73
METHODS MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were queried from January 2000 through May 2016. Only studies comparing SAVR and TAVR were included enrolling patients with non-high surgical risk (low and intermediate risk only). Two independent reviewers selected the studies and extracted data in duplicate. Random-effects meta-analysis was used to pool outcomes across studies. Study primary endpoints were assessed at 1 and 12 months and included: mortality, cerebrovascular accident (CVA) and myocardial infarction (MI). Study secondary endpoints assessed at 1 month including: bleeding (minor and major), acute kidney injury and need for new permanent pacemaker implantation. RESULTS A total of 5223 patients were included from eight studies (4 randomized and 4 observant) comparing SAVR and TAVR. Mean age was 80.1 years and 49% of patients were male. There were no significant differences between the two approaches at one month in terms of mortality (risk ratio RR 0.91, 95% CI: 0.68 to 1.20), or CVA (RR 0.91, 95% CI 0.68 to 1.21). However, MI was lower in the TAVR group (RR 0.57, 95% CI 0.33 to 0.97). At 12 months, there was no significant difference between either strategies in terms of mortality (RR 0.98, 95% CI 0.84-1.13), CVA (RR1.07, 95% CI 0.85-1.33) or MI (RR 0.78, 95% CI 0.53-1.15). With regards to secondary outcomes, TAVR was associated with lower rates of bleeding (RR 0.44, 95% CI 0.22-0.88) and acute kidney injury (RR 0.54, 95% CI 0.31-0.93) but higher need for new permanent pacemaker implantation (RR 2.99, 95% CI 1.51-5.94). CONCLUSION In severe AS patients with non-high surgical risk, TAVR has lower risk of MI at one month, otherwise both TAVR and SAVR yielded similar outcomes at one month in terms of mortality and CVA and at 12 months in terms of mortality, CVA and MI. In regards to secondary outcomes at one month, TAVR has lower rates of bleeding and acute kidney injury, and higher rates of need for new permanent pacemakers. Disclosure: Manuscript submitted to JOIC (under review). CRT-800.34 Prevalence and Predictors of Sleep Apnea in Contemporary Patients Referred for Aortic Valve Replacement: An Analysis of the National Inpatient Sample Database Saurav Chatterjee,1 Anasua Chakraborty,2 Brian O’Neill1 Temple University Hospitals, Philadelphia, PA; 2Thomas Jefferson University Hospitals, Philadelphia, PA
1
BACKGROUND Sleep Apnea (SA) has been noted to be prevalent in patients with valvular heart disorders including aortic stenosis. We evaluated the prevalence and predictors of sleep apnea (both obstructive-OSA and central-CSA) in a national sample of patients admitted for aortic valve replacement-both surgical (SAVR), and transcatheter (TAVR).
RESULTS Among 153,994 patients with aortic stenosis treated with TAVR or SAVR , 12,387 (8.04%%) patients had SA. 99.7% of these patients had OSA. SA patients were more likely to be younger, male, and had a high burden of comorbidities including heart failure, obstructive lung disease, diabetes, and kidney disease (Table 1). CONCLUSION SA, specifically OSA is prevalent among contemporary US patients admitted for AVR-and have a high burden of comorbidities. Meticulous screening for these patients may be warranted. CRT-800.33 Surgical versus Transcatheter Aortic Valve Replacement in Non-High Surgical Risk Severe Aortic Stenosis: A Systematic Review Tariq Enezate,1 Arun Kumar,1 Mazen Abu Fadel,2 Mitul Patel,3 Ashraf Al-Dadah,4 Jad Omran1 1 University of Missouri Columbia, Columbia, MO; 2University of Oklahoma, Oklahoma, OK; 3University of California-San Diego Health Systems, San Deigo, CA; 4Prairie Heart Institute, Springfield, IL INTRODUCTION Transcatether aortic valve replacement (TAVR) has emerged as an acceptable alternative to surgical aortic valve replacement (SAVR) in patients with high-risk surgical profile. In this analysis, we compare both approaches in patients with non-high surgical risk.
Predictors of Odds Ratio
P-value
Age
Sleep Apnea
0.99
<0.001
[95% Confidence. Interval] 0.98
0.99
Female
0.63
<0.001
0.57
0.69
Heart Failure
1.16
0.001
1.06
1.27
Chronic
1.850843
<0.001
1.69
2.02
Diabetes
2.5
<0.001
2.09
2.99
Chronic Kidney
1.12
0.036
1.01
1.24
Obstructive Airway Disease
Disease
VALVE & STRUCTURAL HEART
METHODS From 2011-2013, all patients undergoing SAVR and TAVR were identified from the National Inpatient Sample (NIS) data (representing 20% of all discharges in the US). All SA patients were identified with appropriate ICD 9 codes-(CSA- 327.21, OSA- 327.23, and unspecified-780.57). Prevalence and predictors for SA were noted in this cohort, in a multivariable-adjusted model.
CONCLUSION Advanced dementia is associated with increased length of ICU and hospital stay. However, the clinical significance is marginal and should not preclude the patients from therapy based on our results. Larger studies will need to be performed to assess the primary outcomes that could not be addressed in this study. CRT-800.32 Improvement in Aortic Valve Area in Aortic Stenosis Patients Using a New “Hourglass” Shaped Valvuloplasty Compared with Cylindrical Balloons Wesley Pedersen, Mason Hinke, Pau Sorajja, Aisha Ahmed, Michael Mooney, Irvin Goldberg Minneapolis Heart Institute Foundation, Minneapolis, MN Balloon (bal) aortic valvulopasty (BAV) has reemerged with transcatheter therapy. Cylindrical bal have been the device of choice despite limitations. The V8 (InterValve Inc) bal with broader segments separated by a narrowed waist is designed to permit enhanced fix and better leaflet opening without annular compromise. Reported are our findings using the V8 bal in 40 consecutive, matched patients (pts) undergoing BAV compared to a subset of 40 pts from a 403 pt BAV database using cylindrical bals. Pts were propensity matched by age, gender, left ventricular ejection fraction (LVEF) and Society of Thoracic Surgeons (STS) risk score. Endpoints included change in AVA by echo, change in aortic insufficiency (AI), new permanent pacemaker implantation (PPM) and major adverse event (MAE) which included procedural death, emergency surgery or stoke. Bal sizes for each pt were recorded. AI was quantitated numerically: 0 none to trace, 1+ mild, 2+ moderate, 3+ severe. V8 and cylindrical bal groups were similar across age, sex, STS score, LVEF and baseline AVA. The change in AVA from baseline to post procedure strongly trended in favor of V8 bal pts over cylindrical bal pts (0.29cm20.17 vs. 0.22cm 20.15; p¼0.058). Maximum bal sizes were significantly larger for V8 pts enabled by the bal shape. There were no significant differences in AI, new PPM or MAE. There was no severe AI in either group post procedure. Findings in this preliminary experience suggest an advantage for enhancing AVA when using the V8 bal. In addition, there was no increase in AI, new PPM or MAE events in comparison to the cylindrical bal.
S73
METHODS MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were queried from January 2000 through May 2016. Only studies comparing SAVR and TAVR were included enrolling patients with non-high surgical risk (low and intermediate risk only). Two independent reviewers selected the studies and extracted data in duplicate. Random-effects meta-analysis was used to pool outcomes across studies. Study primary endpoints were assessed at 1 and 12 months and included: mortality, cerebrovascular accident (CVA) and myocardial infarction (MI). Study secondary endpoints assessed at 1 month including: bleeding (minor and major), acute kidney injury and need for new permanent pacemaker implantation. RESULTS A total of 5223 patients were included from eight studies (4 randomized and 4 observant) comparing SAVR and TAVR. Mean age was 80.1 years and 49% of patients were male. There were no significant differences between the two approaches at one month in terms of mortality (risk ratio RR 0.91, 95% CI: 0.68 to 1.20), or CVA (RR 0.91, 95% CI 0.68 to 1.21). However, MI was lower in the TAVR group (RR 0.57, 95% CI 0.33 to 0.97). At 12 months, there was no significant difference between either strategies in terms of mortality (RR 0.98, 95% CI 0.84-1.13), CVA (RR1.07, 95% CI 0.85-1.33) or MI (RR 0.78, 95% CI 0.53-1.15). With regards to secondary outcomes, TAVR was associated with lower rates of bleeding (RR 0.44, 95% CI 0.22-0.88) and acute kidney injury (RR 0.54, 95% CI 0.31-0.93) but higher need for new permanent pacemaker implantation (RR 2.99, 95% CI 1.51-5.94). CONCLUSION In severe AS patients with non-high surgical risk, TAVR has lower risk of MI at one month, otherwise both TAVR and SAVR yielded similar outcomes at one month in terms of mortality and CVA and at 12 months in terms of mortality, CVA and MI. In regards to secondary outcomes at one month, TAVR has lower rates of bleeding and acute kidney injury, and higher rates of need for new permanent pacemakers. Disclosure: Manuscript submitted to JOIC (under review). CRT-800.34 Prevalence and Predictors of Sleep Apnea in Contemporary Patients Referred for Aortic Valve Replacement: An Analysis of the National Inpatient Sample Database Saurav Chatterjee,1 Anasua Chakraborty,2 Brian O’Neill1 Temple University Hospitals, Philadelphia, PA; 2Thomas Jefferson University Hospitals, Philadelphia, PA
1
BACKGROUND Sleep Apnea (SA) has been noted to be prevalent in patients with valvular heart disorders including aortic stenosis. We evaluated the prevalence and predictors of sleep apnea (both obstructive-OSA and central-CSA) in a national sample of patients admitted for aortic valve replacement-both surgical (SAVR), and transcatheter (TAVR).
RESULTS Among 153,994 patients with aortic stenosis treated with TAVR or SAVR , 12,387 (8.04%%) patients had SA. 99.7% of these patients had OSA. SA patients were more likely to be younger, male, and had a high burden of comorbidities including heart failure, obstructive lung disease, diabetes, and kidney disease (Table 1). CONCLUSION SA, specifically OSA is prevalent among contemporary US patients admitted for AVR-and have a high burden of comorbidities. Meticulous screening for these patients may be warranted. CRT-800.33 Surgical versus Transcatheter Aortic Valve Replacement in Non-High Surgical Risk Severe Aortic Stenosis: A Systematic Review Tariq Enezate,1 Arun Kumar,1 Mazen Abu Fadel,2 Mitul Patel,3 Ashraf Al-Dadah,4 Jad Omran1 1 University of Missouri Columbia, Columbia, MO; 2University of Oklahoma, Oklahoma, OK; 3University of California-San Diego Health Systems, San Deigo, CA; 4Prairie Heart Institute, Springfield, IL INTRODUCTION Transcatether aortic valve replacement (TAVR) has emerged as an acceptable alternative to surgical aortic valve replacement (SAVR) in patients with high-risk surgical profile. In this analysis, we compare both approaches in patients with non-high surgical risk.
Predictors of Odds Ratio
P-value
Age
Sleep Apnea
0.99
<0.001
[95% Confidence. Interval] 0.98
0.99
Female
0.63
<0.001
0.57
0.69
Heart Failure
1.16
0.001
1.06
1.27
Chronic
1.850843
<0.001
1.69
2.02
Diabetes
2.5
<0.001
2.09
2.99
Chronic Kidney
1.12
0.036
1.01
1.24
Obstructive Airway Disease
Disease
VALVE & STRUCTURAL HEART
METHODS From 2011-2013, all patients undergoing SAVR and TAVR were identified from the National Inpatient Sample (NIS) data (representing 20% of all discharges in the US). All SA patients were identified with appropriate ICD 9 codes-(CSA- 327.21, OSA- 327.23, and unspecified-780.57). Prevalence and predictors for SA were noted in this cohort, in a multivariable-adjusted model.