Minneapolis Heart Institute Foundation® Cardiovascular Grand Rounds
Title: ACC Scientific Sessions ‐ Preview Speakers: Causes of Death in Patients with Severe Asymptomatic Aortic Stenosis under Active Surveillance
Santiago Garcia, MD, Staff Interventional Cardiologist Minneapolis Heart Institute® at Abbott Northwestern Hospital
Short‐Circuiting and Oversensing Due to Internal Insulation Breaches in an ICD Lead with Redundant Conductors: Implications For Patient Safety and Management Moses K. Wananu, MD, Cardiology Fellow Minneapolis Heart Institute®, Abbott Northwestern Hospital
Contemporary Outcomes of Chronic Total Occlusion Percutaneous Coronary Interventions: Update From the PROGRESS CTO Registry Iosif Xenogiannis, MD, Research Scholar, Minneapolis Heart Institute Foundation®
A Novel Method of Non‐Invasive Screening For Patients With Aortic Stenosis Aisha K. Ahmed, BS, Valve Science Center Intern, Minneapolis Heart Institute Foundation®
Transcatheter Therapy of Residual Mitral Regurgitation After MitraClip Therapy Hiroki Niikura, MD, Research Scholar, Valve Science Center Minneapolis Heart Institute Foundation®
Adverse Outcomes After Acute Aortic Dissection Are Preceded by Changes in Novel Aortic Constant on Serial Imaging Amit Sharma, MD, Cardiology Fellow Minneapolis Heart Institute® at Abbott Northwestern Hospital & Hennepin County Medical Center, Minneapolis, MN
Predictors of Appropriate Implantable Cardioverter Defibrillator Utilization in Patients With Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy Miranda Kunz, MPH, Minneapolis Heart Institute Foundation
Date: March 11, 2019
Time: 7:00 ‐ 8:00 AM Location: ANW Education Building, Watson Room
OBJECTIVES At the completion of this activity, the participants should be able to:
1. Summarize emerging research that colleagues will present at upcoming national scientific meeting. 2. Synthesize ideas and input from across disciplines relevant to each presentation. 3. Recommend content revisions or areas of focus to the presenters.
ACCREDITATION Physician ‐ Allina Health is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Allina Health designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.
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Nurse ‐ This activity has been designed to meet the Minnesota Board of Nursing continuing education requirements for 1.0 hours of credit. However, the nurse is responsible for determining whether this activity meets the requirements for acceptable continuing education.
DISCLOSURE POLICY & STATEMENTS Allina Health, Learning & Development intends to provide balance, independence, objectivity and scientific rigor in all of its sponsored educational activities. All speakers and planning committee members participating in sponsored activities and their spouse/partner are required to disclose to the activity audience any real or apparent conflict(s) of interest related to the content of this conference.
The ACCME defines a commercial interest as “any entity” producing, marketing, re‐selling, or distributing health care goods or services consumed by, or used on, patients. The ACCME does not consider providers of clinical service directly to patients to be commercial interests ‐ unless the provider of clinical service is owned, or controlled by, an ACCME‐defined commercial interest.
Moderator(s)/Speaker(s) Dr. Santiago Garcia has disclosed the following relationships ‐ Medtronic: Consultant; Edwards Lifesciences: Consultant, Previous grant research support; Abbott Vascular: Consultant. Dr. Moses Wananu, Dr. Iosif Xenogiannis, Dr. Hiroki Niikura, Dr. Amit Sharma, Miranda Kunz and Aisha Ahmed have disclosed that they DO NOT have any real or apparent conflicts with any commercial interest as it relates to presenting their content in this activity/course.
Planning Committee Dr. Alex Campbell, Jake Cohen, Jane Fox, Dr. Mario Gössl, Dr. Kevin Harris, Dr. Kasia Hryniewicz, Rebecca Lindberg, Amy McMeans, Dr. Michael Miedema, Dr. JoEllyn Moore, Pamela Morley, Dr. Scott Sharkey, and Jolene Bell Makowesky have disclosed that they DO NOT have any real or apparent conflicts with any commercial interest as it relates to the planning of this activity/course. Dr. David Hurrell has disclosed the following relationship ‐Boston Scientific: Chair, Clinical Events Committee.
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MHIF CV Grand Rounds – March 11, 2019
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Causes of Death in Patients with Severe AsymptomaticAortic Stenosis under Active Surveillance
Santiago Garcia, MD
Minneapolis Heart Institute
Cell: 305‐439‐4083
Santiago Garcia, MD, Stephen George, Md, PhD, Paul Sorajja, MD, Fernando Ortiz, MDSasha Prisco, MD, PhD, Takeshi Onizuka, MD, Mackenzie Mbai, MD
1
• As many as 50% of patients with severe AS report no symptoms at the time of diagnosis
• Current guidelines recommend deferral of aortic valve replacement (AVR) until onset of symptoms for the vast majority of patients with severe asymptomatic aortic stenosis (AS).
• The natural history of AS involves a long asymptomatic period characterized by increased pressure overload and adaptive left ventricular hypertrophy.
• This latency period has traditionally been characterized by a low incidence of clinical events
• Recent studies have challenged the notion that all patients with severe asymptomatic AS have a benign clinical course
1
Background
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MHIF CV Grand Rounds – March 11, 2019
2
ACC/ESC Guidelines
3
Evidence from Observational Studies:Early AVR versus Conservative Management
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4
• 10‐year (2005‐2015) observational study of consecutive U.S.Veterans with severe aortic stenosis (mean gradient 40mmHg, aortic valve area < 1 cm2 and/or peak velocity 4m/sec) who were asymptomatic at the time ofechocardiography.
• Echo database linked to a Computerized Patient RecordSystem (CPRS). Electronic medical records were thenreviewed by trained MDs (residents) to assess symptomaticstatus, baseline demographic, clinical, medication, laboratoryand echocardiographic data.
• In cases with >1 echocardiogram during the study period weused the first one that met criteria for severe AS
• Patients with symptoms of AS (angina, dyspnea, syncope) orreferred for AVR within 6 months of the indexechocardiogram were excluded.
Study Design
5
•Outcomes of interest included death, development ofsymptoms related to AS and surgical or transcatheter aorticvalve replacement.
• Time to event was calculated using the baselineechocardiogram as time zero. For calculating time to deathand AVR we used death certificates and surgical notes,respectively. For symptoms we used the date angina,dyspnea or syncope was first documented in the medicalrecord.
•Outcomes were prospectively defined according to theValve Academic Research Consortium (VARC) definitions andobtained through review of electronic medical records,surgical notes and death certificates when applicable.
Methods (Cont’d)
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6
•A total of 1,181 echocardiograms met echocardiographic inclusion criteria.
•Of these, 857 were excluded because of symptoms, referral to AVR within 6 months, or duplicate echocardiograms leaving a total of 324 patients in the final study cohort.
Results
7
Results: Baseline Characteristics Overall (n=324)
Conservative (n=177)
AVR (n=147)
P value
Age (years) mean± SD 78 ±10 80 ±10 76 ±9 <0.001Diabetes (%) 104 (32) 60 (35) 44 (31) 0.41
Arterial hypertension (%) 258 (80) 138 (80) 117 (79) 0.80Hyperlipidemia (%) 267 (83) 142 (82) 122 (85) 0.44Current smoker (%) 50 (15) 24 (14) 24 (17) 0.78
COPD (%) 46 (14) 24 (14) 21 (15) 0.62CAD (%) 121 (37) 69 (39) 52 (36) 0.73
Atrial fibrillation (%) 56 (17) 35 (19) 21 (15) 0.41Previous PCI (%) 38 (12) 23 (13) 15 (10) 0.36
Previous CABG (%) 38 (12) 22 (13) 28 (12) 0.88Previous MI (%) 53 (16) 32 (18) 22 (14) 0.34Previous HF (%) 41 (13) 21 (12%) 22 (15%) 0.39
Charlson comorbidity index (CCI) median‐ IQR
5 (3‐6) 4.5 (3‐6) 5 (3‐6) 0.96
Estimated 10‐year survival (%)median‐ IQR
21% (2‐77) 37% (2‐77) 22% (2‐77) 0.77
MedicationsAspirin (%) 228 (72) 121 (70) 106 (75) 0.37
Beta‐blockers (%) 150 (47) 90 (52) 61 (42) 0.09Statins (%) 225 (71) 126 (73) 99 (68) 0.33ACEI (%) 134 (42) 75 (43) 62 (42) 0.87ARB (%) 38 (12) 20 (11) 18 (12) 0.83
Anticoagulants (%) 57 (17) 32 (18) 24 (16) 0.60
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Echocardiography
Echocardiographic Variables (mean ± SD)
Overall (n=324) Conservative (n=177)
AVR (n=147)
P value
Aortic valve area (cm2) 0.84 ±0.11 0.85 ±0.10 0.83 ±0.13 0.06
Peak aortic jet velocity (m/s) 3.6 ±0.60 3.56 ±0.65 3.73 ±0.60 0.02
Mean gradient (mmHg) 33 ±12 31 ±12 35 ±11 0.005
Dimensionless index 0.26 ±0.04 0.26 ±0.03 0.25 ±0.03 0.22
Indexed AVA (cm2 m2) 0.06 ±0.02 0.06 ±0.03 0.06 ±0.01 0.05
Ejection fraction (EF) 57 ±7 56 ±8 58 ±6 0.03
Posterior wall thickness (mm) 13 ±2 13 ±2 13 ±2 0.17
Septal wall thickness (mm) 13 ±1.8 13 ±1.8 13±1.6 0.06
9
Survival probability of initially asymptomatic patients with severe aortic stenosis according to performance of AVR or
conservative management
AVR
Conservative
P<0.001
Covariate Hazard Ratio 95 % CI P‐value
Age (per increase in decile) 1.14 1.05 – 1.24 <0.01
Aortic valve replacement 0.15 0.09 ‐ 0.28 <0.01
Aortic valve area 0.33 0.03 – 3.30 0.34
Mean aortic gradient 1.00 0.98 ‐ 1.03 0.63
Ejection fraction 0.98 0.95 ‐ 1.01 0.22
Peak aortic jet velocity 1.12 0.74 ‐ 1.70 0.56
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10
Causes of death in patients with severe asymptomatic aortic stenosis
41%
48%
11%
Causes of Death
CV death Non‐CV death Indeterminate
• A total of 47 patients (14% of the cohort and 48% of deaths) expired before AS symptoms were documented in their medical records (1.5% - 2% per year)
• A detailed analysis of death certificates revealed that 19 of these deaths (41%) were cardiovascular, 22 (47%) were non-cardiovascular and 6 were undetermined because they occurred in another state
11
•Among elderly patients with severe asymptomatic AS, a significant proportion of fatal events occurred before the onset of symptoms and were cardiovascular in origin.
• Valve replacement was strongly associated with improved long‐term survival.
• Our study highlights the difficulty of relying on symptoms alone for timely referral to AVR surgery.
Conclusion
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12
To AVR or NOT
13
EARLY TAVR Trial
Enrollment completion estimated in 2020, 30% of patients enrolled to date
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Managing the Aging Heart
15
Causes of Death in Patients with Severe AsymptomaticAortic Stenosis under Active Surveillance
Santiago Garcia, MD
Minneapolis Heart Institute
Cell: 305‐439‐4083
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MHIF CV Grand Rounds – March 11, 2019
Short-Circuiting and Oversensing Due to Internal Insulation Breaches in an ICD Lead with Redundant Conductors: Implications For Patient
Safety and Management.
Moses K. Wananu, MD*, Robert G. Hauser MD FACC*, Jay Sengupta MD FACC*, Edward J. Schloss MD FACC**, Larissa I. Stanberry* PhD, Raed Abdelhadi MD FACC*
*Minneapolis Heart Institute Foundation, Minneapolis MN, USA**The Christ Hospital/The Ohio Heart & Vascular Center, Cincinnati, OH, USA
Background
oThe Durata ICD lead (Abbott/St Jude Medical) was designed to mitigate the conductor cable externalization (EC) and internal insulation breaches (IBR) that resulted in the Class I recall of Riata and Riata ST leads.
oA novel outer insulation (Optim™) was added to the Durata lead but the dual conductor design was retained, whereby two cable conductors are confined within a single oblong lumen.
oWhile Durata EC appears to be infrequent, reports of Durata failures raise the possibility that the IBRs observed in Riata and Riata ST leads may be affecting Durata lead performance.
oImportantly, IBRs may short-circuit conductors to each other or to the shocking coils, and this may result in inappropriate shocks, pacing inhibition, and/or failure to convert VT/VF.
A-Sprint Quattro Secure
EndotakReliance
Durata
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Objectives
oAssess the occurrence, characteristics, and clinical consequences of Durata IBR in the FDA MAUDE database.
oMAUDE contains the results of manufacturers’ engineering analyses of leads that have been removed from patients.
o Compare these results to similar MAUDE data for Endotak Reliance (ER; Boston Scientific, Inc.) and Sprint Quattro Secure (QS; Medtronic, Inc.).
Methods
oThe MAUDE database was searched for each lead using the simple terms “breach’, “abrasion” “under coil”, “noise and coil”, “short”, “receipt”, “analysis”, “returned”, and “exposed’, for the years 2008-2018.
oA lead was included if
othe manufacturer concluded that the lead failed due to an insulation breach
oor conductor fracture that was not caused by extrinsic factors such as clavicular crush and extraction damage.
oThe incidence of Durata IBR was estimated based on the number of U.S. implants.
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MHIF CV Grand Rounds – March 11, 2019
ResultsDurata Quattro Secure Endotak Reliance
No. LeadsAverage (±SD) implant time (yrs)
3164.5±2.2
5233.6±2.2
2054.3±2.3
Primary cause of failure
Insulation breach 293 (93%) 83 (16%) 78 (38%)
Internal (IBR) 137 (47%) 9 -
Outer 156 57 75
Internal + outer - 17 3
Conductor fracture 10 (3%) 438 (84%) 77 (38%)
High voltage 1 79 19
Pace/sense 9 309 (71%) 57
High voltage + Pace/sense - 35 -
Multiple (>2 fractures) - 15 1
Coil and/or electrode calcification - - 49 (24%)
Indeterminate 13 (4%) 2 (<1%) 1 (<1%)
Serious Adverse Events/Cause
Failure to terminate VT/VF 12 - 3
Internal insulation breachOuter insulation breachCalcification of HV coil
111-
---
-21
Inappropriate shocks or ATPInternal insulation breachOuter insulation breachConductor fracture
8851343
96-7
89
47-
1236
Syncope/asystoleInternal insulation breachOuter insulation breachConductor fracture
312-
3--3
2-11
Results
oFailure to terminate VT/VF due to IBR was associated with a low HV
impedance found during DFT testing (n=3), after a shock (n=7) and remote
transmission (n=1); 4 patients received low HV impedance alerts at home.
oQuattro Secure and Endotak Reliance leads seldom had IBRs and none was
under a shocking coil or caused a major adverse clinical event.
oSince only 5-10% of leads are returned for analysis, and most leads are
abandoned in situ, the actual incidences are likely much higher.
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MHIF CV Grand Rounds – March 11, 2019
The incidence of Durata IBR and adverse events
# U.S. Implants Internal Insulation Breaches*# Rate/10,000
Major Adverse Events**# Rate/10,000
Dual Coil 191,302 109 5.7 48 2.5
Single Coil 100,538 28 2.8 15 1.5
All leads 291,840 137 4.7 63 2.2
*Dual coil vs single coil p<0.001; the risk of internal breach in dual coil design is 2.0 (95%CI 1.3-3.2) times higher than single coil models.
**Dual coil vs single coil p=0.08; the risk of major adverse events in dual coil is 1.7 (95%CI 0.9- 3.1) times higher than in single coil models.
Conclusion
• Durata leads are susceptible to IBR that may result in serious adverse clinical events, including failure to treat VT/VF and inappropriate shocks.
• Durata IBRs under the shocking coils appear to be similar to those found in Riata and Riata ST leads; they were not found in either Quattro Secure or Endotak Reliance leads.
• Low HV impedance and failure to treat VT/VF occurred exclusively in dual coil Durata models. Thus, it may be appropriate to exclude the proximal SVC coil from the shock pathway.
• Since painless HV conductor impedance measurements may not detect IBRs, diagnostic HV shocks should be considered at the time of generator change or when concerns exist about the integrity of a lead’s insulation.
• Like Riata leads, the constant movement of redundant cables within a single lumen is a plausible explanation for Durata IBRs
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Disclosures
• Moses K. Wananu MD: None
• Robert G. Hauser MD FACC: Equity Interest/Stock Options, Cardiac Insight, Inc.
• Jay Sengupta MD FHRS: Research grant, Medtronic, Inc.
• Edward J. Schloss MD FHRS: Consulting Fees/Honoraria, Medtronic; Consulting Fees/Honoraria, Boston Scientific. Speakers Bureau, Medtronic. Equity Interests/Stock Options, AliveCor.
• Larissa I. Stanberry PhD: None
• Raed Abdelhadi MD FHRS: Research grant, Medtronic, Inc.
• Note: The accepted manuscript is available at https://doi.org/10.1016/j.hrthm.2019.02.019
Short-Circuiting and Oversensing Due to Internal Insulation Breaches in an ICD Leadwith Redundant Conductors: Implications For Patient Safety and Management.
Moses K. Wananu, MD*, Robert G. Hauser MD FACC*, Jay Sengupta MD FACC*, Edward J. Schloss MD FACC**,Larissa I. Stanberry* PhD, Raed Abdelhadi MD FACC*
*Minneapolis Heart Institute Foundation, Minneapolis MN, USA**The Christ Hospital/The Ohio Heart & Vascular Center, Cincinnati, OH, USA
Conclusions
. .
Results
◦
Abstract Background
Background: Internal insulation breaches (IBR) may result in ICD lead failure and adverse clinical events. Concerns exist that the Durata lead may be prone to IBR.
Objective: Assess Durata failures in the FDA MAUDE database and compare them to failures in MAUDE for Endotak Reliance (ER) and Sprint Quattro Secure (QS) leads.
Methods: We searched the MAUDE database from 2008-2018 for IBR and other failure modes. Included were explanted leads whose manufacturers found an insulation or conductor defect not caused by extrinsic factors.
Results: The MAUDE search found 1,011 qualifying leads. Cause of failure differed among leads (p<0.001). The primary cause of Durata failure was insulation breach (293 of 316 leads; 93%), with IBR accounting for 47% (137/293); few QS (9/523;1.7%) and no ER leads failed due to IBR (p<0.001). Durata IBR were responsible for 11 failures to treat VT/VF, and all were caused by high-voltage (HV) shorts between the proximal (SVC) coil and a distal right ventricular coil cable (n=10) or sensing conductor (n=1); low values of HV impedance were found in these leads during DFT testing (n=3), after a shock or aborted shock (n=7), and by an alert (n=1). Inappropriate therapy (IARx) was caused by 51 Durata IBR but no QS IBR.
Conclusion: Durata ICD leads are susceptible to IBR that may result in failure to treat VT/VF or IARx; such failures may occur without forewarning. HV testing of Durata leads may be indicated during pulse generator replacement or when an insulation defect is suspected.
Objectives
Methods
o Assess the occurrence, characteristics, and clinical consequences of Durata IBR in the FDA MAUDE database. MAUDE contains the results of manufacturers’ engineering analyses of leads that have been removed from patients.
o Compare these results to similar MAUDE data for Endotak Reliance (ER; Boston Scientific, Inc.) and Sprint Quattro Secure (QS; Medtronic, Inc.).
o The MAUDE database was searched for each lead using the simple terms “breach’, “abrasion” “under coil”, “noise and coil”, “short”, “receipt”, “analysis”, “returned”, and “exposed’, for the years 2008-2018.
o A lead was included if the manufacturer concluded that the lead failed due to an insulation breach or conductor fracture that was not caused by extrinsic factors such as clavicular crush and extraction damage.
o The incidence of Durata IBR was estimated based on the number of U.S. implants.
Figure 1: A-Sprint Quattro Secure; B- Durata; C- Endotak Reliance. Dark blue ETFE insulation covers cable conductors. Light blue PTFE insulation covers the
inner coil.
Disclosures
o The Durata ICD lead (Abbott/St Jude Medical) was designed to mitigate the conductor cable externalization (EC) and internal insulation breaches (IBR) that resulted in the Class I recall of Riata and Riata ST leads.
o A novel outer insulation (Optim™) was added to the Durata lead but the dual conductor design was retained, whereby two cable conductors are confined within a single oblong lumen (Figure1B).
o While Durata EC appears to be infrequent, reports of Durata failures raise the possibility that the IBRs observed in Riata and Riata ST leads may be affecting Durata lead performance.
o Importantly, IBRs may short-circuit conductors to each other or to the shocking coils, and this may result in inappropriate shocks, pacing inhibition, and/or failure to convert VT/VF.
o 1,044 leads qualified for the study (Table 1)o The causes of lead failure differed significantly between models
(p<0.001).o For Durata, the commonest cause of failure was an insulation breach
and 47% of these were IBRs.o The commonest cause of Quattro Secure failure was conductor
fracture and 71% of these involved the pace/sense conductor.o An equal proportion of Endotak leads failed due to insulation breaches
and conductor fractures, and 24% malfunctioned due to electrode calcification.
o 12 Durata lead failures resulted in failure to terminate VT/VF, resulting in one death. All involved dual coil Durata models, and 11 of the 12 (92%) were caused by an IBR under the proximal SVC shocking coil.
o Failure to terminate VT/VF due to IBR was associated with a low HV impedance found during DFT testing (n=3), after a shock (n=7) and remote transmission (n=1); 4 patients received low HV impedance alerts at home.
o Quattro Secure and Endotak Reliance leads seldom had IBRs and none was under a shocking coil or caused a major adverse clinical event.
o The incidence of Durata IBR and adverse events are shown in Table 2. Since only 5-10% of leads are returned for analysis, and most leads are abandoned in situ, the actual incidences are likely much higher.
Table 1. Cause of lead failure and serious adverse clinical events.Durata Quattro Secure Endotak Reliance
No. LeadsAverage (±SD) implant time (yrs)
3164.5±2.2
5233.6±2.2
2054.3±2.3
Primary cause of failureInsulation breach 293 (93%) 83 (16%) 78 (38%)
Internal 137 9 -Outer 156 57 75Internal + outer - 17 3
Conductor fracture 10 (3%) 438 (84%) 77 (38%)High voltage 1 79 19Pace/sense 9 309 57
High voltage + Pace/sense - 35 -Multiple (>2 fractures) - 15 1
Coil and/or electrode calcification
- - 49 (24%)
Indeterminate 13 (4%) 2 (<1%) 1 (<1%)
Serious Adverse Events/CauseFailure to terminate VT/VF 12 - 3
Internal insulation breachOuter insulation breachCalcification of HV coil
111-
---
-21
Inappropriate shocks or ATPInternal insulation breachOuter insulation breachConductor fracture
8851343
96-789
47-
1236
Syncope/asystoleInternal insulation breachOuter insulation breachConductor fracture
312-
3--3
2-11
Table 2. Incidence of Durata lead internal insulation breaches and major adverse events based on U.S. registered implants.
# U.S. Implants Internal Insulation Breaches*# Rate/10,000
Major Adverse Events**# Rate/10,000
Dual Coil 191,302 109 5.7 48 2.5Single Coil 100,538 28 2.8 15 1.5All leads 291,840 137 4.7 63 2.2
*Dual coil vs single coil p<0.001; the risk of internal breach in dual coil design is 2.0 (95%CI 1.3-3.2) times higher than single coil models. **Dual coil vs single coil p=0.08; the risk of major adverse events in dual coil is 1.7 (95%CI 0.9- 3.1) times higher than in single coil models.
o Durata leads are susceptible to IBR that may result in serious adverse clinical events, including failure to treat VT/VF and inappropriate shocks.
o Durata IBRs under the shocking coils appear to be similar to those found in Riata and Riata ST leads; they were not found in either Quattro Secure or Endotak Reliance leads.
o Low HV impedance and failure to treat VT/VF occurred exclusively in dual coil Durata models. Thus, it may be appropriate to exclude the proximal SVC coil from the shock pathway.
o Since painless HV conductor impedance measurements may not detect IBRs, diagnostic HV shocks should be considered at the time of generator change or when concerns exist about the integrity of a lead’s insulation.
o Like Riata leads, the constant movement of redundant cables within a single lumen is a plausible explanation for Durata IBRs (Figure 2).
Figure 2. Illustration of Durata lead depicting an insulation breach under the SVC coil (arrow). The cable to the distal RV shocking coil has abraded from inside-out through the inner silicone and ETFE, allowing the cable to short to the SVC coil.
Moses K. Wananu MD: NoneRobert G. Hauser MD FACC: Equity Interest/Stock Options, Cardiac Insight, Inc.Jay Sengupta MD FHRS: Research grant, Medtronic, Inc.Edward J. Schloss MD FHRS: Consulting Fees/Honoraria, Medtronic; Consulting Fees/Honoraria, Boston Scientific. Speakers Bureau, Medtronic. Equity Interests/Stock Options, AliveCor.Larissa I. Stanberry PhD: NoneRaed Abdelhadi MD FHRS: Research grant, Medtronic, Inc.Note: The accepted manuscript is available at https://doi.org/10.1016/j.hrthm.2019.02.019
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MHIF CV Grand Rounds – March 11, 2019
Contemporary Outcomes of Chronic Total Occlusion
Percutaneous Coronary Interventions: Update From the
PROGRESS CTO (PROspective Global REgiStry for the
Study of Chronic Total Occlusion Intervention) Registry
Iosif Xenogiannis, MD
Minneapolis Heart Institute, Abbott Northwestern HospitalMinneapolis Heart Institute Foundation
I, Iosif Xenogiannis DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.
Disclosure Statement of Financial Interest
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MHIF CV Grand Rounds – March 11, 2019
1Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN; 2Columbia University, New York, NY; 3Henry Ford Hospital, Detroit,
MI; 4Massachusetts General Hospital, Boston, MA; 5Beth Israel Deaconess Medical Center, Boston, MA; 6VA San Diego Healthcare System and
University of California San Diego, La Jolla, CA; 7Baylor Heart and Vascular Hospital, Dallas, TX; 8Medical Center of the Rockies, Loveland, CO;
9University of Pittsburgh Medical Center, Pittsburgh, PA; 10Meshalkin Novosibirsk Research Institute, Novosibirsk, Russia; 11The Heart Hospital
Baylor Plano, Plano, TX; 12Torrance Memorial Medical Center, Torrance, CA; 13Piedmont Heart Institute, Atlanta, GA; 14Red Cross Hospital of
Athens, Athens, Greece; 15Cleveland Clinic, Cleveland, OH; 16Emory University Hospital Midtown, Atlanta, GA; 17Tristar Centennial Medical Center,
Nashville, TN; 18University of Szeged, Division of Invasive Cardiology, Second Department of Internal Medicine and Cardiology Center, Szeged,
Hungary; 19VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, TX.
Iosif Xenogiannis1, MD, Dimitri Karmpaliotis2, MD, Khaldoon Alaswad3, MD, Farouc A. Jaffer4,
MD, PhD, Robert W. Yeh5, MD, Mitul Patel6, MD, Ehtisham Mahmud6, MD, James W. Choi7, MD,
M. Nicholas Burke1, MD, Antony H. Doing8, MD, Catalin Toma9, MD, Oleg Krestyaninov10, MD,
Dmitrii Khelimskii10, MD, Srinivas Potluri11, MD, R. Michael Wyman12, MD, David E. Kandzari13,
MD, Michalis Koutouzis14, MD, Jaikirshan J. Khatri15, MD, Wissam Jaber16, MD, Taral Patel17,
MD, Peter Tajti1,18, MD, Allison Hall1, MD, Bavana V. Rangan19, BDS, MPH, Shuaib Abdullah19,
MD, Subhash Banerjee19, MD, Emmanouil S. Brilakis1, MD, PhD
Funding: Abbott Northwestern Hospital Foundation
Appleton Cardiology, WIK. Alaswad
Mid America Heart Institute, MO J.A. Grantham
Dallas VAMC, TXS. Abdullah, H. Khalili
Minneapolis VAMC, MNS. Garcia
Providence Health Center, TXC. Shoultz
PeaceHealth St. Joseph Medical Center, WA W. Lombardi
Henry Ford, MI K. Alaswad
CAVHS, ARB. Uretsky
Baylor Dallas, TXJ. Choi
Medical Center of the Rockies, COA. Doing, P. Dattilo
Tulane, LAN. Abi-Rafeh, O. Mogabgab
Piedmont Heart Institute, GAD. Kandzari
UT Southwestern, TXS. Banerjee
Northwestern Cardiovascular Institute, ILM. Ricciardi
Minneapolis Heart Institute, MN N. Burke, E.S. Brilakis
Baylor Plano, TXE. HolperS. Potluri
Banner Samaritan Medical Center, AZ A. Pershad
Memorial Hospital, FLL. Van-Thomas Crisco
Tristar Centennial, TNB. Jefferson, T. Patel
Emory Hospital, GAW. Jaber, H. Samady
UPMC, PAC. Toma, A.J. Conrad Smith
Trinity Medical, NYH. Meltser
Carolina East HC, NC D. Jessup, M. Groove, Alex R. Kirby
Maimonides MC, NYB.A. Malik
CWRU, OHM. Costa, H. Bezerra, P. Poommipanit, F. Forouzandeh
Columbia University, NYD. Karmpaliotis, J. Moses, N. Lembo, A.J. Kirtane, R. Hatem, M. Parikh, Z. Ali
San Diego VAMC and UCSD, CAE. Mahmud, M. Patel
Torrance Medical Center, CAM.R. Wyman
Massachusetts General Hospital, MAF. Jaffer
Beth Israel Deaconess MC, MAR.W. Yeh
Cleveland Clinic, OH J. Khatri
Houston Methodist, TXA. Shah, J. Parker
WellStar Health System, GAA. Sheikh
Oklahoma City VAMC, OKC. Adams, F. Latif
International sites:
Kogialeneio-Benakeio Hellenic Red Cross, GreeceM. Koutouzis, Y. Tsiafoutis
Henry Dunant Heart Hospital, GreeceV. Tzifos, A. Kolyviras, D. Damaskos
Meshalkin Novosibirsk Research Institute, Russian RepublicO. Krestyaninov, D. Khelimskii
St. Boniface General Hospital, CanadaB. Elbarouni, K Atwal, M. Love, X. Patel
St. George Hospital University Medical Center, LebanonA. Maalouf, F. A., Jaoudeh, G. Maalouf, K. Jbara, N.A. Rafeh
• Aswan Heart Center, Magdi Yacoub Foundation, EgyptA. ElGuindy
The Christ Hospital, OH R. Riley, J. Kong, J. Reginelli
Kettering Health Network, OH N. Redd
NCT02061436
Wellspan York Hospital,PAW. Nicholson
43 Sites – Study PI: E. S. Brilakis – National Coordinator: B.V. Rangan – Database Manager: I. Xenogiannis
4,148 CTO PCIs in 4,055 patients
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Definitions CTO: Coronary lesions with Thrombolysis in Myocardial Infarction (TIMI) grade 0 flow of at least 3
months duration.
Technical success: Achievement of <30% residual diameter stenosis within the treated segment and
restoration of TIMI grade 3 antegrade flow.
Procedural success: Achievement of technical success without any in-hospital major adverse cardiac
events (MACE).
In-hospital MACE: Death, myocardial infarction, recurrent symptoms requiring urgent repeat target
vessel revascularization with PCI or coronary artery bypass graft surgery (CABG), tamponade requiring
either pericardiocentesis or surgery, and stroke
Age (years) 64.53±10.12
Male gender (%) 84.11
BMI (kg/m2) 30.61±6.27
Smoking (current) (%) 26.16
Diabetes (%) 41.98
Dyslipidemia (%) 89.38
Hypertension (%) 90.48
Prior MI (%) 47.50
Heart failure (%) 30.73
Prior valve surgery or procedure (%) 2.93
Prior PCI (%) 64.22
Prior CABG (%) 31.93
Baseline creatinine (mg/dL) 1.02 (0.9, 1.21)
Left ventricular EF (%) 54 (42, 60)
Ad-hoc CTO PCI 12.90
Clinical Characteristics
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Target vessel (%)RCA 54.88LCX 19.33LAD 24.17
Interventional collaterals (%) 56.97J-CTO score 2.41± 1.31PROGRESS score 1.34±1.04PROGRESS complication score 2.98±1.92First crossing strategyAWE (%) 78.83ADR (%) 6.99Retrograde (%) 14.18
Final crossing strategyAWE (%) 47.89ADR (%) 16.91Retrograde (%) 22.04None (%) 13.17
Angiographic and Technical Characteristics
Procedural Results
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Technical success Procedural success In‐hospital MACE
87% 85%
2.4%
Technical and procedural success, in‐hospital MACE
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Limitations
Observational retrospective study with no long-term-follow up.
No core lab analysis.
Procedures were performed in dedicated, high volume CTO
centers by experienced operators, limiting the extrapolation to
less experienced operators and lower volume centers.
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Conclusion
Using a combination of crossing strategies, high success and
acceptable complication rates can currently be achieved in CTO PCI
among various experienced operators and centers.
A Novel Method of Non-Invasive Screening for Patients with Aortic Stenosis
Aisha Ahmed, Ross Garberich, Mario Goessl, Lisa Tindell, Kari Williams, Sarah Dennis, Richard Bae, Paul Sorajja
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Background
• Aortic Stenosis (AS) affects ≈4% of persons >65 years of age
• AS is underdiagnosed and undertreated
• AS is detected by:1. Auscultation with a stethoscope 2. Transthoracic echocardiography (TTE)
Study Aim
• There is a need for a simple cost-effective technique to diagnose AS at the point-of-care in order to drive referrals to heart centers for further evaluation
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Methods• Vivio (Avicena LLC) is a novel wireless device capable of acquiring the arterial pulse and
the heart sound waveforms in order to detect cardiovascular disease
• Hemodynamic waveforms are captured by holding the Vivio against the neck near where the carotid pulse can be felt
• Vivio recordings are streamed wirelessly, in real-time to a Bluetooth connected tablet for analysis
Tonometry
When a patient has severe AS the upstroke of the pulse waveform is delayed and there is additional turbulence in the blood as it moves through the valve. The Vivio detects both this delayed upstroke (pulse) and the turbulent blood flow (sound) to determine the presence of stenosis
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Inclusion/ Exclusion Criteria
• AS was diagnosed using standard TTE criteria outlined in the 2014 AHA/ACC Valvular Heart Disease Guidelines
• Inclusion criteria: all adult subjects (age ≥18) undergoing a 2D and Doppler TTE at Abbott Northwestern Hospital, with written consent
• Exclusion criteria: patients still feeling effects of sedation, or patients with history of carotid sinus hypersensitivity and/or carotid artery stenosis
Results
• We measured 105 patients in 3 cohorts: no AS (n=78), moderate AS (n=11), and severe AS (n=16)
• The median recording time for Vivio was 105.91 seconds (IQR 70.44 to 127.64)
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Baseline Characteristics
Confusion Matrix
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Boxplot ROC Curve
Conclusions• Vivio is a novel device capable of diagnosing AS patients quickly and
accurately at the point-of-care by a nurse practitioner, technician or physician in a matter of minutes
• Widespread use of this novel technology could make a profound contribution to the identification of this lethal condition that remains undiagnosed in a large number of patients
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Transcatheter Therapy of Residual Mitral Regurgitation after MitraClip Therapy
Hiroki Niikura, MDResearch scholarValve Science Center at the Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital
Mitral Regurgitation (MR) and MitraClip
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BackgroundResidual or recurrent MR after MitraClip may occur in up to 5 to 40% of
patients and has been associated with persistent symptoms and impaired survival.For residual MR grade≧3+, the cumulative incidence of death at one year
was 48.9%.
The cause of residual or recurrent MR after MitraClip are variable such as para / interclip MR, and leaflet perforation. Therefore, for these patients, subsequent transcatheter MitraClip therapy can be difficult.
Sorajja P, et al. JACC. 2017
Aims
We examined the effectiveness and the optimal technique for transcatheter therapy for residual MR after MitraClip with AVP-II plugs.
Amplatzer Vascular Plug type II (AVP-II)
• Low profile• Configured with three same diameter segments
(Two retention disks and central waist)• Various device sizes and less expensive device
AVP-II
Clips
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Nine patients with prior MitraClipunderwent transcatheter therapy of residual MR with an AVP-II plug during the past 5 years at our institution.
Results Table. Baseline characteristics and echo findings (n=9)Age (yrs) 78±4Male gender - no. (%) 7 (78)NYHA functional class - no. (%)
III 7 (78)IV 2 (22)
Frailty – no. (%) 5 (56)STS predicted risk of mortality (%)
Mitral valve repair 5.6±5.2Mitral valve replacement 7.6± 5.9
Etiology of MR - no. (%)Degenerative 8 (89)Functional 0Both degenerative and functional 1 (13)Prior failed surgery or trans catheter repair 7 (78)Rheumatic 0
MR grade 4+ 9 (100)Type of residual MR
Leaflet perforation 1 (13)Intra clip 4 (44)Para clip 4 (44)
Left ventricular ejection fraction (%) 52.9±14.8
Case example
LA
LV
Clips
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The waist of the device placed in the coaptation plane of the mitral valve leaflets
LA
LV
AVP-II
LA
LV
AVP-II
Only one segment in the LA side and both the waist and the distal segment in the LV side
AVP-II
MR was significantly reduced to trivial
LA
LV
AVP-II
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Results
Pre Final p valueMR Grade 4+ 1+ p<0.0001NYHA class 3.2±0.4 2.3±0.8 p=0.013Mitral gradient (mmHg) 3.3±0.7 3.4±1.0 p=0.8
The median follow-up duration was 155 (IQR, 133, 244) daysSize of AVP-II12mm - n. (%) 6 (65)16mm - n. (%) 2 (22)22mm - n. (%) 1 (13)
Final position of the AVP-II - n. (%)Two segments in the LV side, one segment in the LA side 8 (87)The central waist in the coaptation plane of the mitral leaflets 1 (13)
Procedural mortality 0Emergent cardiac surgery 0All cause death at 30 days 0Stroke at 30 days 0MI at 30 days 0Device embolization at final follow-up 0Hemolysis at final follow-up 0
Conclusions
Transcatheter therapy with placement of AVP-II plugs for residual or recurrent MR after MitraClip may be effective and safe,especially when deployed with only the one segment on the left atrial side of the mitral leaflets.
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Amit Sharma MD, Jasmine C Curry, Larissa I Stanberry Ph.D, Ross F Garberich MS MBA, Matthew P Pavlovec
RN, John R Lesser MD, Jesse M Manunga MD, Domenico Calcaterra MD, Jessica M Titus MD, Karol Mudy MD, and
Kevin M Harris MD
Monday March 11th, 2019
The authors have no disclosures to report.
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Patients with aortic dissection (AD) who survive the acute event remain at risk for long term adverse events (AE)
ACC/AHA aortic guidelines recommend routine clinical and imaging follow‐up after AD
Clinicians rely on clinical and a multitude of imaging measures that are imprecise in predicting future risk
There is a need to better risk stratify patients into those requiring more frequent follow up and imaging and conversely those who require less
Define annual progression in aortic size by type of dissection and segment of aorta
Identify the imaging and clinical risk factors associated with AE following AD
Evaluate whether changes in novel aortic constant are associated with future AE
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Patients with acute AD from 2005 to 2016 alive at hospital discharge
AE was defined as a composite of all‐cause death, recurrent dissection, aneurysm development (> 5.5 cm), and re‐intervention
Aortic major and minor diameter and false lumen diameter at ascending, arch, and proximal, mid, and distal descending segments were measured at baseline (t = 0) and follow up (t = T)
Follow up image defined as last visit on record or last visit prior to AE
Aortic blood flow modeled as incompressible fluid flowing through a cylindrical pipe with flow rate dependent on the shape of aortic cross‐section
L = length of the aortic segment, Δp = change in pressure over L, ρ = blood density, η = blood viscosity, and C is a function of the major (M) and minor (m) aortic diameters
C = aortic constant and constants at baseline (C0) and follow up (CT) were computed
The annual change in the aortic constant is
Q Cp
4L,where C
mM 3
4 m2 M 2
CTC
0 T
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Table 1: Baseline demographics and clinical characteristics of the cohort
Table 2: Change in aortic diameter, aortic constant, and false lumen diameter..
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Figure 1 and 2. Change in major (left) and minor (right) aortic diameters over time in patients with and without AE.
Figure 3 and 4. Change in aortic constant (left) and false lumen diameter (right) over time in patients with and without AE.
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Table 3. Univariate analysis
Table 4. Multivariate analysis model 1 (top) and model 2 (bottom)
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118 patients (81 type A, 37 type B) with 29 AE’s (aneurysm > 5.5 cm = 19, death = 7, re‐intervention =2, and re‐AD = 1).
The false lumen maximal diameter (p = 0.03), false lumen growth rate (p = < 0.001), and aortic constant (p = 0.001) were predictive of AE at follow up
• Differential growth is seen across aortic segments after AD
• Baseline false lumen diameter is associated with AE
• Annual change in aortic constant is associated with increased hazard of AE
• These measurements may potentially be used to build a predictive model to identify high risk patients after AD
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The authors would like to thank the Abbott Northwestern Hospital Foundation for their ongoing support of research and the MHIF internship program.
Predictors of Appropriate Implantable Cardioverter Defibrillator Utilization in Patients with Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy (ARVD/C)
Sajya Singh1, Aaron Thomas1, Sue Casey1, Katelyn Storey1, Miranda Kunz1, Allison
Berg2, William Katsiyiannis1,2, Raed Abdelhadi1,2, Mosi Bennett1,2, Jay Sengupta1,2
1Minneapolis Heart Institute Foundation, Minneapolis, Minnesota 2Minneapolis Heart Institute at Abbott
Northwestern Hospital, Minneapolis, Minnesota
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Disclosures
• None
Background• Arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C) is characterized by
fibrous or fatty replacement of the myocardium, which can lead to congestive heart failure and life-threatening ventricular arrhythmias
• There are limited recommendations regarding the use of implantable cardioverter defibrillators (ICD) in patients with ARVD/C
Patient without ARVD/C Patient with ARVD/C
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2017 AHA/ACC/HRS Guideline1
• For patients with ARVD/C, an ICD is recommended if meaningful survival greater than 1 year is expected and if they have an increased risk of sudden cardiac death (SCD):
1. Resuscitated SCA (secondary prevention of SCD)2. Sustained VT (secondary prevention of SCD)3. Significant ventricular dysfunction with RVEF or LVEF ≤35%
• Furthermore, an ICD can be useful if meaningful survival greater than 1 year is expected in patients with syncope presumed due to ventricular arrhythmias
Aim
• To identify the characteristics associated with appropriate therapy in ARVD/C patients who underwent ICD implantation for primary prevention of SCD and compare these to the established guidelines
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MethodsPatients in the Genetic Arrhythmia Center Research Registry (n=340)
ARVD/C patients with ICDs (n=60)
Appropriate therapy
(n=10; 21%)
No appropriate therapy
(n=37; 79%)
Patients diagnosed with ARVD/C guided by the 2010 Task Force Criteria2 (n=68)
Patients implanted with ICDs for primary prevention of SCD (n=47)
Results
• 10 patients (21%) experienced appropriate therapy • Median time to first therapy: 1.7 years (range from 1 month to 7.5 years)
• Characteristics associated with appropriate therapy• Lower RV EF (p = 0.017)• Not significant associations: syncope, documented NSVT, family history of SCD, LV
EF, age at diagnosis
• Complications• Total (10, 21%): lead failure/breakdown (9, 19%) and thrombus (1, 2%)• Patients with inappropriate device therapy (8, 17%)
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Results
ParameterPrimary
Prevention ICD (n = 47)
With appropriate therapy (n=10)
Without appropriate therapy (n = 37)
P-value
Male gender, n (%) 20 (43) 3 (30) 17 (46) 0.48Caucasian, n (%) 46 (98) 9 (90) 37 (100) 0.21Age at ARVC diagnosis (years), mean ± SD 41.6 ± 16.7 41.0 ± 18.6 41.7 ± 16.5 0.90Age at ICD implant (years), mean ± SD 42.2 ± 16.6 41.4 ± 18.6 42.5 ± 16.2 0.85Cardiac deaths, n (%) 1 (2) 1 (10) 0 (0) 0.21Risk FactorsFamily history of SCD, n (%) 29 (62) 5 (50) 24 (65) 0.47Family history of ARVC, n (%) 32 (68) 3 (30) 29 (78) 0.007Documented NSVT, n (%) 14 (30) 4 (40) 10 (27) 0.23Syncope, n (%) 11 (23) 2 (20) 9 (24) 1.00CMR data at initial visitRV wall motion abnormality, n (%) 27 (57) 4 (40) 23 (62) 0.69LV wall motion abnormality, n (%) 3 (6) 1 (10) 2 (5) 0.43RV EF (%), mean ± SD 54 ± 11 45 ± 13 56 ± 9 0.017LV EF (%), mean ± SD 62 ± 9 58 ± 11 63 ± 8 0.14RV EDV (mL/m2) , mean ± SD 101 ± 31 115 ± 17 98 ± 33 0.29LV EDV(mL/m2) , mean ± SD 86 ± 20 91 ± 21 85 ± 20 0.55
Results
0
10
20
30
40
50
60
70
PrimaryPrevention ICD
Withappropriate
therapy
Withoutappropriate
therapy
RV E
F (%
)
0
20
40
60
80
100
120
140
PrimaryPrevention ICD
Withappropriate
therapy
Withoutappropriate
therapy
RV E
DV (m
L/m
2)
p=0.017p=0.29
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Conclusions
• The 2017 Guideline define two risk factors to aid in the decision to place a primary prevention ICD in patients with ARVD/C (ventricular dysfunction and possibly cardiac syncope)
1. LV involvement and other CMR characteristics, including delayed enhancement, require further investigation to determine their significance among our cohort
2. Our findings are in accordance with the 2017 Guideline as we found RV EF to be a associated with appropriate ICD use. This is clinically relevant as RV EF can easily be obtained from CMR studies already routinely collected on these patients.
• Our data support the use of ICDs for primary prevention, particularly in patients with advanced structural changes to the right ventricle.
Acknowledgements
• The authors would like to thank and acknowledge the Minneapolis Heart Institute Foundation and Medtronic, Inc. for their support of this project.
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References
• 1. Al-Khatib Sana M., et al. “2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.” Circulation, vol. 138, no. 13, Sept. 2018, pp. e272–391. ahajournals.org (Atypon), doi:10.1161/CIR.0000000000000549.
• 2. Marcus, Frank I., et al. “Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia (ARVC/D).” Circulation, vol. 121, no. 13, Apr. 2010, pp. 1533–41. PubMed Central, doi:10.1161/CIRCULATIONAHA.108.840827.
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Thank You!
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