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TCT-268 Patent Foramen Ovale Closure to treat Obstructive Sleep Apnea – the PCOSA pilot study
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 70, NO. 18, SUPPL B, 2017
BACKGROUND The efficacy of device closure for patent foramen ovale (PFO) for crypotenic stroke has been controversial. We undertook a meta-analysis of the totality of randomised evidence comparing device closure with medical therapy for PFO, including the two randomised controlled trials (RCTs) recently reported at ESOC 2017.
PFO AND LAA CLOSURE
Abstract nos: 268 - 272 TCT-268 Patent Foramen Ovale Closure to treat Obstructive Sleep Apnea – the PCOSA pilot study Stephen Hoole,1 William Davies,1 Duncan McNab,1 Bushra Rana,1 Patrick Calvert,2 Michael Davies1 1 Papworth Hospital, Cambridge, United Kingdom; 2Papworth Hospital NHS Foundation Trust, Cambridge, United Kingdom BACKGROUND Studies have shown a higher prevalence of patent foramen ovale (PFO) in patients with obstructive sleep apnoea (OSA). Right to left shunting via a PFO may be encouraged by OSA respiratory physiology, contributing to OSA pathophysiology. We assessed whether PFO closure would improve respiratory polygraphy parameters compared to baseline in patients with OSA. METHODS Twenty-six patients with newly diagnosed OSA and a moderate-large PFO (prevalence 18% of 143 patients screened) were referred for PFO closure. PFO closure was completed in 24 patients (1 withdrew and 1 technically not feasible). The oxygen desaturation index (ODI), apnoea-hypopnoea index (AHI), Epworth Sleepiness Score (ESS), 6-minute walk test (6MWT), Sleep Apnoea Quality of Life Index (SAQLI), Functional outcome of sleep questionnaire (FOSQ) and Short form 36 (SF36) were compared in these patients at baseline (before continuous positive pressure ventilation (CPAP) was initiated) and at 6-months follow-up (after interrupting CPAP for 1 week). RESULTS All PFO were safely sealed at 6-months as confirmed by repeat transthoracic echocardiography bubble study. The ODI (44.8 IQR 31.2-63.5 vs. 42.3 IQR 34.0-60.8, p¼0.89) and AHI (47.9 IQR 31.565.2 vs. 42.3 IQR 32.1-63.7, p¼0.99) did not change after PFO closure, and nor did the 6MWT although the ESS and quality of life indices did improve (Table: p-value by Wilcoxon’s rank sum test). CPAP adherence prior to discontinuation, did not completely explain the ESS findings (regression coefficient ¼ -0.29 ESS decrease/ hour of CPAP use, se¼0.34, p¼0.40). Baseline pre closure Outcome
IQR
Median
IQR
47.9
31.5 - 65.2
42.3
32.1 – 63.7
0.99
ODI
44.8
31.2 – 63.5
42.3
34.0 – 60.8
0.89
0.99 505.5
0.87-1.07 478.8 – 526.8 12 – 16.8
0.99
0.88-1.03
0.93
443.8 – 523.8
0.73
6
4.0 – 8.8
<0.001
48.5
43.1 – 54.3
0.44
489.5
RESULTS 5 studies, enrolling 3440 patients, were included. 1829 patients were randomised to device closure and 1611 to medical therapy, with a weighted mean follow up of 3.15 years. PFO closure was superior to medical therapy for prevention of stroke (HR 0.31, 95% confidence interval (CI) 0.12 to 0.79, p¼0.015, heterogeneity I2 ¼ 69.8%). With device closure the annual incidence of recurrent stroke was low (0.63%), and half that compared to medical therapy (1.13%). Device closure, however, caused a significant increase in peri-procedural AF (RR 4.56, 95% CI 1.87 to 11.14, p<0.001); nevertheless, overall rates of new AF were low (1.35% per year in the device arm, and 0.23% per year in the control arm).
CONCLUSION In patients with cryptogenic stroke and PFO, device closure is superior to medical therapy for the prevention of further stroke.
p-value
Median
6MWT (m)
METHODS We systematically identified all RCTs comparing device closure to medical therapy for cryptogenic stroke. The primary efficacy endpoint was stroke, analysed on an intention-to-treat basis. The primary safety endpoint was new onset atrial fibrillation (AF). A generic inverse method was used in a random-effects model.
CATEGORIES STRUCTURAL: Congenital and Other Structural Heart Disease
6 months post closure
AHI
ODI/AHI
B111
ESS
13
SF36
51.9
45.0 – 55.6
SAQLI
3.4
2.8 - 4.3
4.4
3.9 – 5.3
<0.001
FOSQ
2.9
2.7 – 3.2
3.6
3.4 – 3.7
<0.001
CONCLUSION The prevalence of moderate-large PFO in OSA appears to be no higher than in the general population. Although PFO closure is safe and effective it did not improve respiratory polygraphy measures of OSA severity and therefore should not be recommended. The improvement in ESS and SAQLI likely reflect residual benefits from CPAP. CATEGORIES STRUCTURAL: Congenital and Other Structural Heart Disease
TCT-269 PFO Closure is Superior to Medical Therapy for Cryptogenic Stroke: a meta-analysis of randomised controlled trials Yousif Ahmad,1 Matthew Shun-Shin,1 James Howard,1 Christopher Cook,1 Ricardo Petraco,2 Ozan Demir,2 Ghada Mikhail,2 Nilesh Sutaria,2 Chris Baker,3 Justin Davies,1 Jamil Mayet,1 Darrel Francis,4 Iqbal Malik,2 Sayan Sen2 1 Imperial College London, London, United Kingdom; 2Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom; 3Imperial College, london, United Kingdom; 4National Heart and Lung Institute, London, UK, London, United Kingdom
TCT-270 Comparison of Cardiac Computerized Tomography Angiography and Transesophageal Echocardiography For Device Surveillance After Endovascular Left Atrial Appendage Closure Sadia Qamar,1 Jacqueline Saw,2 Savvas Nicolaou,3 Sabeena Jalal,3 Michael Tsang3 1 University of British Columbia/Vancouver General Hospital, Vancouver, British Columbia, Canada; 2Vancouver General Hospital, Vancouver, BC, British Columbia, Canada; 3Vancouver General Hospital, Vancouver, British Columbia, Canada BACKGROUND Routine surveillance after endovascular left atrial appendage (LAA) closure is important to assess for device success and complications, such as peri-device leak and device-associated thrombus. There is limited data on the role of cardiac computerized tomography angiography (CCTA) for post-LAA device monitoring. METHODS We retrospectively analyzed consecutive series of patients with non-valvular atrial fibrillation who underwent LAA closure and had both TEE and CCTA performed post-LAA closure for device surveillance. Prospective cardiac-gated CCTA were performed with Toshiba 320-detector or Siemens 2nd generation 128-slice dual source scanners, and digital post-processing and interpretations were performed with IMPAX 3-D reformats. GFR <30mL/min/1.73m2 was an exclusion for CCTA. We assessed for residual contrast patency of the LAA by comparing linear attenuation coefficient (Hounsfield unit, HU) in the LAA and left atrium (LA) on CCTA. Residual contrast patency was categorized as due to peri-device leak (presence of ostial peridevice gap) or fabric leak (diffusion of contrast through the PET membrane). We also assessed for device compression, thrombus and pericardial effusion on CCTA. These findings were compared to TEE, including the presence and size of the leak with color Doppler. Data was analyzed with Stata version 14.2.
BACKGROUND The efficacy of device closure for patent foramen ovale (PFO) for crypotenic stroke has been controversial. We undertook a meta-analysis of the totality of randomised evidence comparing device closure with medical therapy for PFO, including the two randomised controlled trials (RCTs) recently reported at ESOC 2017.
PFO AND LAA CLOSURE
Abstract nos: 268 - 272 TCT-268 Patent Foramen Ovale Closure to treat Obstructive Sleep Apnea – the PCOSA pilot study Stephen Hoole,1 William Davies,1 Duncan McNab,1 Bushra Rana,1 Patrick Calvert,2 Michael Davies1 1 Papworth Hospital, Cambridge, United Kingdom; 2Papworth Hospital NHS Foundation Trust, Cambridge, United Kingdom BACKGROUND Studies have shown a higher prevalence of patent foramen ovale (PFO) in patients with obstructive sleep apnoea (OSA). Right to left shunting via a PFO may be encouraged by OSA respiratory physiology, contributing to OSA pathophysiology. We assessed whether PFO closure would improve respiratory polygraphy parameters compared to baseline in patients with OSA. METHODS Twenty-six patients with newly diagnosed OSA and a moderate-large PFO (prevalence 18% of 143 patients screened) were referred for PFO closure. PFO closure was completed in 24 patients (1 withdrew and 1 technically not feasible). The oxygen desaturation index (ODI), apnoea-hypopnoea index (AHI), Epworth Sleepiness Score (ESS), 6-minute walk test (6MWT), Sleep Apnoea Quality of Life Index (SAQLI), Functional outcome of sleep questionnaire (FOSQ) and Short form 36 (SF36) were compared in these patients at baseline (before continuous positive pressure ventilation (CPAP) was initiated) and at 6-months follow-up (after interrupting CPAP for 1 week). RESULTS All PFO were safely sealed at 6-months as confirmed by repeat transthoracic echocardiography bubble study. The ODI (44.8 IQR 31.2-63.5 vs. 42.3 IQR 34.0-60.8, p¼0.89) and AHI (47.9 IQR 31.565.2 vs. 42.3 IQR 32.1-63.7, p¼0.99) did not change after PFO closure, and nor did the 6MWT although the ESS and quality of life indices did improve (Table: p-value by Wilcoxon’s rank sum test). CPAP adherence prior to discontinuation, did not completely explain the ESS findings (regression coefficient ¼ -0.29 ESS decrease/ hour of CPAP use, se¼0.34, p¼0.40). Baseline pre closure Outcome
IQR
Median
IQR
47.9
31.5 - 65.2
42.3
32.1 – 63.7
0.99
ODI
44.8
31.2 – 63.5
42.3
34.0 – 60.8
0.89
0.99 505.5
0.87-1.07 478.8 – 526.8 12 – 16.8
0.99
0.88-1.03
0.93
443.8 – 523.8
0.73
6
4.0 – 8.8
<0.001
48.5
43.1 – 54.3
0.44
489.5
RESULTS 5 studies, enrolling 3440 patients, were included. 1829 patients were randomised to device closure and 1611 to medical therapy, with a weighted mean follow up of 3.15 years. PFO closure was superior to medical therapy for prevention of stroke (HR 0.31, 95% confidence interval (CI) 0.12 to 0.79, p¼0.015, heterogeneity I2 ¼ 69.8%). With device closure the annual incidence of recurrent stroke was low (0.63%), and half that compared to medical therapy (1.13%). Device closure, however, caused a significant increase in peri-procedural AF (RR 4.56, 95% CI 1.87 to 11.14, p<0.001); nevertheless, overall rates of new AF were low (1.35% per year in the device arm, and 0.23% per year in the control arm).
CONCLUSION In patients with cryptogenic stroke and PFO, device closure is superior to medical therapy for the prevention of further stroke.
p-value
Median
6MWT (m)
METHODS We systematically identified all RCTs comparing device closure to medical therapy for cryptogenic stroke. The primary efficacy endpoint was stroke, analysed on an intention-to-treat basis. The primary safety endpoint was new onset atrial fibrillation (AF). A generic inverse method was used in a random-effects model.
CATEGORIES STRUCTURAL: Congenital and Other Structural Heart Disease
6 months post closure
AHI
ODI/AHI
B111
ESS
13
SF36
51.9
45.0 – 55.6
SAQLI
3.4
2.8 - 4.3
4.4
3.9 – 5.3
<0.001
FOSQ
2.9
2.7 – 3.2
3.6
3.4 – 3.7
<0.001
CONCLUSION The prevalence of moderate-large PFO in OSA appears to be no higher than in the general population. Although PFO closure is safe and effective it did not improve respiratory polygraphy measures of OSA severity and therefore should not be recommended. The improvement in ESS and SAQLI likely reflect residual benefits from CPAP. CATEGORIES STRUCTURAL: Congenital and Other Structural Heart Disease
TCT-269 PFO Closure is Superior to Medical Therapy for Cryptogenic Stroke: a meta-analysis of randomised controlled trials Yousif Ahmad,1 Matthew Shun-Shin,1 James Howard,1 Christopher Cook,1 Ricardo Petraco,2 Ozan Demir,2 Ghada Mikhail,2 Nilesh Sutaria,2 Chris Baker,3 Justin Davies,1 Jamil Mayet,1 Darrel Francis,4 Iqbal Malik,2 Sayan Sen2 1 Imperial College London, London, United Kingdom; 2Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom; 3Imperial College, london, United Kingdom; 4National Heart and Lung Institute, London, UK, London, United Kingdom
TCT-270 Comparison of Cardiac Computerized Tomography Angiography and Transesophageal Echocardiography For Device Surveillance After Endovascular Left Atrial Appendage Closure Sadia Qamar,1 Jacqueline Saw,2 Savvas Nicolaou,3 Sabeena Jalal,3 Michael Tsang3 1 University of British Columbia/Vancouver General Hospital, Vancouver, British Columbia, Canada; 2Vancouver General Hospital, Vancouver, BC, British Columbia, Canada; 3Vancouver General Hospital, Vancouver, British Columbia, Canada BACKGROUND Routine surveillance after endovascular left atrial appendage (LAA) closure is important to assess for device success and complications, such as peri-device leak and device-associated thrombus. There is limited data on the role of cardiac computerized tomography angiography (CCTA) for post-LAA device monitoring. METHODS We retrospectively analyzed consecutive series of patients with non-valvular atrial fibrillation who underwent LAA closure and had both TEE and CCTA performed post-LAA closure for device surveillance. Prospective cardiac-gated CCTA were performed with Toshiba 320-detector or Siemens 2nd generation 128-slice dual source scanners, and digital post-processing and interpretations were performed with IMPAX 3-D reformats. GFR <30mL/min/1.73m2 was an exclusion for CCTA. We assessed for residual contrast patency of the LAA by comparing linear attenuation coefficient (Hounsfield unit, HU) in the LAA and left atrium (LA) on CCTA. Residual contrast patency was categorized as due to peri-device leak (presence of ostial peridevice gap) or fabric leak (diffusion of contrast through the PET membrane). We also assessed for device compression, thrombus and pericardial effusion on CCTA. These findings were compared to TEE, including the presence and size of the leak with color Doppler. Data was analyzed with Stata version 14.2.