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Unique Complications Associated with Patient Ambulation in the Setting of Percutaneous Axillary Intra-Aortic Balloon Pump
The 22nd Annual Scientific Meeting HFSA surgery had a transplant free survival of 92.5%(CI: 89.5-95.4%) per 100 PY and a low rate of need for pacemaker (0.5% / year; CI: 0.2-0.8%). 84.7% patients (CI: 79.689.9%) were found to be in NYHA functional class I or II after 100 PY follow up. Total re-intervention rate was 5.3% per year (CI: 3.8-6.8%). Incidence of baffle stenosis, AV valve dysfunction, neo-aortic insufficiency and LVOT obstruction were estimated at 1.1% (CI: 0.8-1.5%); 0.3% (CI: 0.2-0.5%); 0.5% (CI: 0.2-0.9%) and 0.4% (CI: 0.1-0.6%) per year. Rate of development of LV dysfunction was 1.7%/ year (CI: 1.0-2.4%). Conclusions: Despite a relatively high operative mortality, our study provides favorable updated estimates for follow-up outcomes after anatomic repair for cc-TGA patients. The pooled data suggests need for active monitoring over the long term for important complications including heart block and worsening ventricular dysfunction despite majority of patients being in NYHA class I/II.
317 Cardiac Autonomic Nerves Stimulation Improves Hemodynamics: A Pilot Study in Advanced Heart Failure Patients Temıstocles Dıaz1, Christian Marin y Kall2, John Boehmer3, Martin Cowie4, Alexander Mebazaa5, Michael Cuchiara6; 1Pacıfica Salud Hospital Punta Pacıfica, Panama City, Panama; 2University of Miami, Miami, FL; 3Penn State Hershey Heart and Vascular Institute, Hershey, PA; 4Imperial College London, London, United Kingdom; 5University Paris Diderot, Paris, France; 6NeuroTronik Inc, Durham, NC Introduction: Despite therapy advances in the management of heart failure, symptomatic congestion in acute heart failure is a leading cause of mortality and morbidity. The purpose of this study was to investigate transvenous cardiac autonomic nerve stimulation (CANS) effects on in-hospital hemodynamics and signs and symptoms of congestion. Methods: The study was a single-center, observational, clinical investigation of CANS. Five (5) subjects with reduced left ventricular ejection fraction (LVEF < 40%), and at least two signs and symptoms of congestion were enrolled. A purpose-built electrical stimulation catheter was percutaneously placed in the left brachiocephalic vein via left subclavian vein access. A purpose-built neurostimulator was then connected to the catheter and used to deliver CANS for up to 24 hours. Hemodynamic effects and signs and symptoms of congestion were observed over the stimulation period. The majority of the subjects were male (3/5), had a mean age of 65 years, mean body mass index of 34, mean NTproBNP of 3622 pg/mL and a mean Pulmonary Capillary Wedge Pressure (PCWP) of 30 mmHg. CANS was provided for a mean of 18 hours. Results: There were no adverse events reported. LVEF increased in all subjects (mean +8% from 27% to 35%) over the stimulation period. LVEF acutely decreased a mean of -5% (from a mean of 35% to 30%) in direct association with stimulation cessation. In three (3) subjects, CANS directly modulated arterial pulse pressure (12% average change) with a neutral heart rate effect (< 1% average change) over the stimulation period. PCWP decreased in all subjects (mean reduction of 10 mmHg) over the stimulation period. PCWP improvements were accompanied by dyspnea and edema improvements from pre-study to discharge. The hemodynamic and clinical improvements occurred in the presence of minimal changes to concomitant medical therapy. Conclusion: Alongside concomitant medical therapy, CANS directly improved hemodynamics and was associated with improved signs and symptoms of congestion. These improvements, coupled with a positive safety profile, demonstrate that CANS holds promise as a tool to improve in-hospital hemodynamics and congestion. The present study included limited duration CANS, in a specific patient phenotype, and a small number of subjects. Future study is warranted to investigate CANS for longer durations, in expanded patient phenotypes, and in more subjects.
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treatment options in patients presenting with severely decompensated end stage heart failure (HF) and cardiogenic shock. Hypothesis: The Impella 5.0 can serve as an effective bridge to recovery or as an optimization tool for long-term support in patients with cardiogenic shock. Methods: A retrospective review was performed on all consecutive patients supported with Impella 5.0 from August 2017 to February 2018 at Froedtert and the Medical College of Wisconsin. Results: A total of 19 Impella 5.0 devices were implanted in men and women as a “bridge to decision” regarding the potential for recovery vs. evaluation for long-term ventricular assist device (VAD). Eleven patients presented in cardiogenic shock and 8 in severely decompensated HF. All implantations were performed via axillary approach. The average number of pressors was 0.9 (range 0-3 pressors). The average norepinephrine dose was 0.15 mcg (range 0.04 - 0.33 mcg) and epinephrine 0.10 mcg (range 0.06 - 0.15 mcg). After Impella implantation, patients were on pressors for an average of 1.4 days (range 0 - 4 days). The average length of Impella duration was 14 days (range 0 - 36 days). There were no major adverse complications from prolonged Impella support. No devices malfunctioned and there were no reported strokes or major bleeding events. Two (11%) patients had hemolysis requiring device removal on days 6 and 18 respectively. Thrombocytopenia requiring more than 10 units of platelets occurred in 2 patients (11%). Seven patients (37%) died and twelve (63%) survived. Of those that survived seven (37%) regained their ejection fraction (EF) and five (26%) had a VAD placed. Of the seven (37%) that died, four were not VAD candidates (for psychosocial reasons) so decided on hospice/withdrawal of care and the other three died of worsening HF and rupture of a chronic abdominal aortic aneurysm. Conclusions: Prolonged hemodynamic support with Impella 5.0 is a safe and viable option for patients presenting with decompensated HF and cardiogenic shock as a bridge to decision strategy. Use of Impella support for more than 10 days was safe and did not result in major adverse events. This type of strategy allows for thorough evaluation for viable VAD candidates and offers potential for cardiac recovery in a sub-group of patients.
319 LVAD Care for the Rural Population: A Single-Center Experience Sagar S. Damle, Gina Mentzer, Kelly Stutzman, Anuj Jain, Adnan Khalid; CHI Health Nebraska Heart, Lincoln, NE Objectives: LVAD therapy is an established treatment for patients with advanced heart failure. However, the persistent risk of long-term complications including pump thrombosis, GI bleeds and infection, requires close follow-up and care of these patients. This attentive care can be complicated in patients living in rural communities, distant from the implanting LVAD center, and may therefore complicate the post-implant outcomes for these patients, compared to patients living in urban settings or in close proximity to an LVAD center. We therefore chose to compare the outcomes of patients living in rural vs urban settings after DT-LVAD implantation. Methods: A retrospective review of all LVAD implants performed at our center was undertaken. Patients who died in the perioperative period were excluded. Midterm outcomes for patients living in rural Nebraska were compared to patients living in the two largest urban centers in the state. Results: A total of 40 LVAD implants occurred in patients who were discharged alive after the implant procedure. Of those, 19 were performed in patients living in urban centers, within 30 miles of an LVAD center. Thirty-day readmissions were somewhat more frequent in patients in urban settings (16% vs 9%). However, 68% of patients living in a rural setting experienced at least 1 readmission in the first year after implant, while only 52% of patients in an urban setting experienced any readmission. In the first year, stroke rates were higher in the rural-residing patients (10% vs 5%) while rates of major bleeds (4.7% rural vs 5.2% urban) and driveline infection rates were similar. One patient in the rural group died within 1 year after discharge, while there were no deaths in the urban-residing patients within the 1st year. At 2 years the actual survival was 76% in the rural-residing patients and 89% in the urban-residing patients. Conclusions: LVAD therapy can be safely instituted in patients residing in rural settings. Although geography may limit some access to care, mid-term outcomes after implantation are acceptable. Our data suggests a trend towards higher rates of strokes and bleeds in patients residing in rural settings. In addition, there is a suggestion that patients residing in an urban setting with LVADs may experience improved long-term survival.
320 Unique Complications Associated with Patient Ambulation in the Setting of Percutaneous Axillary Intra-Aortic Balloon Pump Tanushree Agrawal, Antonio Duran, Omar F. Tamimi, Ana S. Cruz Solbes, Barry Trachtenberg, Ashrith Guha, Arvind Bhimaraj; Houston Methodist Hospital, Houston, TX
318 Impella 5.0 as a Bridge to Clinical Decision Making Daniel Nelson, Asim Mohammed; Medical College of Wisconsin, Milwaukee, WI Introduction: Mortality from cardiogenic shock remains a significant clinical challenge. Short term mechanical circulatory support devices have the potential to improve outcomes. The Impella 5.0 is currently FDA approved for up to 10 days. We report our institutional experience with the Impella 5.0 as a means to improve survival and expand
Introduction: We had previously published a percutaneous technique of axillary intra-aortic balloon pump (IABP) placement in patients being bridged to transplant for facilitation of ambulation and physical recovery. However, this enhanced mobility of the patient may predispose to a higher risk of IABP malposition with unique complications compared to the non-ambulatory state of femoral IABP therapy. We present our experience to illustrate this. Methods: We conducted a retrospective chart review of patients that received percutaneous axillary IABP at our hospital from October 2015 to February 2018. Results: A total of 75 patients had percutaneous axillary IABP insertion during the study period. Of these, 2 had gross IABP malposition into the arch of aorta and 5 patients had superior mesenteric artery (SMA) occlusion by IABP. Table 1 describes the specifics of these patients. Conclusion: There has been a wealth of experience with femoral IABP use wherein the malpositions
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Journal of Cardiac Failure Vol. 24 No. 8S August 2018 Table 1. Results. Total duration of IABP support (days)
Initial manifestation of malposition
Imaging
Sudden onset abdominal pain, signs of peritonitis and leucocytosis Abdominal pain, nausea, vomiting
Abdominal CT scan: pneumatosis coli (Image 2) with portal venous gas (Image 3) Abdominal CT scan: IABP tip and distal segments in SMA
On-going
Abdominal discomfort
Abdominal CT scan: mesenteric ischemia, IABP tip in SMA
ESHF: BTT
22
Abdominal CT scan: distal IABP marker in SMA
34
Fluoroscopy: IABP tip in SMA
IABP repositioned
Male
ESHF: Bridge to decision (BTD) ESHF: BTD
IABP alarms; Chest X-ray showed IABP proximal marker at T2 verteberal level. Abnormal arterial wave-form
Fluoroscopy: IABP coiled in aorta
IABP exchange
Male
ESHF: BTT
27
Chest X-ray: IABP markers at T5 and T6 vertebral levels respectively (Image 1). Abdominal Xray showed no IABP marker Chest X-ray: IABP markers at T5 and T9 levels respectively (Image 4). Abdominal X-ray showed distal IABP marker at T9 level.
Fluoroscopy: IABP proximal end was bent and flopped over itself into ascending aorta
IABP exchange
Indication for IABP
Patient
Age (years)
Sex
A
51
Male
Refractory unstable angina
9
B
53
Male
13
C
58
Male
End-stage heart failure (ESHF): Bridge to transplant (BTT) ESHF: BTT
D
66
Male
E
70
Male
F
65
G
56
27
Management and outcome Emergent right hemicolectomy IABP exchanged, abdominal pain resolved IABP repositioned, abdominal discomfort resolved IABP exchange
described above have not been reported. As utilization of IABP in the axillary position to promote ambulation is increasing, it is imperative to understand and expect such unique complications for prompt diagnosis and management.
Image 3. (Patient A): Abdominal CT scan showing portal venous gas.
Image 1. Chest X-ray of Patient F (Yellow arrows pointing to the IABP markers).
Image 4. Chest X-ray of Patient G (yellow arrows pointing to the IABP markers). Image 2. (Patient A): Abdominal CT scan showing pneumatosis coli.
317 Cardiac Autonomic Nerves Stimulation Improves Hemodynamics: A Pilot Study in Advanced Heart Failure Patients Temıstocles Dıaz1, Christian Marin y Kall2, John Boehmer3, Martin Cowie4, Alexander Mebazaa5, Michael Cuchiara6; 1Pacıfica Salud Hospital Punta Pacıfica, Panama City, Panama; 2University of Miami, Miami, FL; 3Penn State Hershey Heart and Vascular Institute, Hershey, PA; 4Imperial College London, London, United Kingdom; 5University Paris Diderot, Paris, France; 6NeuroTronik Inc, Durham, NC Introduction: Despite therapy advances in the management of heart failure, symptomatic congestion in acute heart failure is a leading cause of mortality and morbidity. The purpose of this study was to investigate transvenous cardiac autonomic nerve stimulation (CANS) effects on in-hospital hemodynamics and signs and symptoms of congestion. Methods: The study was a single-center, observational, clinical investigation of CANS. Five (5) subjects with reduced left ventricular ejection fraction (LVEF < 40%), and at least two signs and symptoms of congestion were enrolled. A purpose-built electrical stimulation catheter was percutaneously placed in the left brachiocephalic vein via left subclavian vein access. A purpose-built neurostimulator was then connected to the catheter and used to deliver CANS for up to 24 hours. Hemodynamic effects and signs and symptoms of congestion were observed over the stimulation period. The majority of the subjects were male (3/5), had a mean age of 65 years, mean body mass index of 34, mean NTproBNP of 3622 pg/mL and a mean Pulmonary Capillary Wedge Pressure (PCWP) of 30 mmHg. CANS was provided for a mean of 18 hours. Results: There were no adverse events reported. LVEF increased in all subjects (mean +8% from 27% to 35%) over the stimulation period. LVEF acutely decreased a mean of -5% (from a mean of 35% to 30%) in direct association with stimulation cessation. In three (3) subjects, CANS directly modulated arterial pulse pressure (12% average change) with a neutral heart rate effect (< 1% average change) over the stimulation period. PCWP decreased in all subjects (mean reduction of 10 mmHg) over the stimulation period. PCWP improvements were accompanied by dyspnea and edema improvements from pre-study to discharge. The hemodynamic and clinical improvements occurred in the presence of minimal changes to concomitant medical therapy. Conclusion: Alongside concomitant medical therapy, CANS directly improved hemodynamics and was associated with improved signs and symptoms of congestion. These improvements, coupled with a positive safety profile, demonstrate that CANS holds promise as a tool to improve in-hospital hemodynamics and congestion. The present study included limited duration CANS, in a specific patient phenotype, and a small number of subjects. Future study is warranted to investigate CANS for longer durations, in expanded patient phenotypes, and in more subjects.
S119
treatment options in patients presenting with severely decompensated end stage heart failure (HF) and cardiogenic shock. Hypothesis: The Impella 5.0 can serve as an effective bridge to recovery or as an optimization tool for long-term support in patients with cardiogenic shock. Methods: A retrospective review was performed on all consecutive patients supported with Impella 5.0 from August 2017 to February 2018 at Froedtert and the Medical College of Wisconsin. Results: A total of 19 Impella 5.0 devices were implanted in men and women as a “bridge to decision” regarding the potential for recovery vs. evaluation for long-term ventricular assist device (VAD). Eleven patients presented in cardiogenic shock and 8 in severely decompensated HF. All implantations were performed via axillary approach. The average number of pressors was 0.9 (range 0-3 pressors). The average norepinephrine dose was 0.15 mcg (range 0.04 - 0.33 mcg) and epinephrine 0.10 mcg (range 0.06 - 0.15 mcg). After Impella implantation, patients were on pressors for an average of 1.4 days (range 0 - 4 days). The average length of Impella duration was 14 days (range 0 - 36 days). There were no major adverse complications from prolonged Impella support. No devices malfunctioned and there were no reported strokes or major bleeding events. Two (11%) patients had hemolysis requiring device removal on days 6 and 18 respectively. Thrombocytopenia requiring more than 10 units of platelets occurred in 2 patients (11%). Seven patients (37%) died and twelve (63%) survived. Of those that survived seven (37%) regained their ejection fraction (EF) and five (26%) had a VAD placed. Of the seven (37%) that died, four were not VAD candidates (for psychosocial reasons) so decided on hospice/withdrawal of care and the other three died of worsening HF and rupture of a chronic abdominal aortic aneurysm. Conclusions: Prolonged hemodynamic support with Impella 5.0 is a safe and viable option for patients presenting with decompensated HF and cardiogenic shock as a bridge to decision strategy. Use of Impella support for more than 10 days was safe and did not result in major adverse events. This type of strategy allows for thorough evaluation for viable VAD candidates and offers potential for cardiac recovery in a sub-group of patients.
319 LVAD Care for the Rural Population: A Single-Center Experience Sagar S. Damle, Gina Mentzer, Kelly Stutzman, Anuj Jain, Adnan Khalid; CHI Health Nebraska Heart, Lincoln, NE Objectives: LVAD therapy is an established treatment for patients with advanced heart failure. However, the persistent risk of long-term complications including pump thrombosis, GI bleeds and infection, requires close follow-up and care of these patients. This attentive care can be complicated in patients living in rural communities, distant from the implanting LVAD center, and may therefore complicate the post-implant outcomes for these patients, compared to patients living in urban settings or in close proximity to an LVAD center. We therefore chose to compare the outcomes of patients living in rural vs urban settings after DT-LVAD implantation. Methods: A retrospective review of all LVAD implants performed at our center was undertaken. Patients who died in the perioperative period were excluded. Midterm outcomes for patients living in rural Nebraska were compared to patients living in the two largest urban centers in the state. Results: A total of 40 LVAD implants occurred in patients who were discharged alive after the implant procedure. Of those, 19 were performed in patients living in urban centers, within 30 miles of an LVAD center. Thirty-day readmissions were somewhat more frequent in patients in urban settings (16% vs 9%). However, 68% of patients living in a rural setting experienced at least 1 readmission in the first year after implant, while only 52% of patients in an urban setting experienced any readmission. In the first year, stroke rates were higher in the rural-residing patients (10% vs 5%) while rates of major bleeds (4.7% rural vs 5.2% urban) and driveline infection rates were similar. One patient in the rural group died within 1 year after discharge, while there were no deaths in the urban-residing patients within the 1st year. At 2 years the actual survival was 76% in the rural-residing patients and 89% in the urban-residing patients. Conclusions: LVAD therapy can be safely instituted in patients residing in rural settings. Although geography may limit some access to care, mid-term outcomes after implantation are acceptable. Our data suggests a trend towards higher rates of strokes and bleeds in patients residing in rural settings. In addition, there is a suggestion that patients residing in an urban setting with LVADs may experience improved long-term survival.
320 Unique Complications Associated with Patient Ambulation in the Setting of Percutaneous Axillary Intra-Aortic Balloon Pump Tanushree Agrawal, Antonio Duran, Omar F. Tamimi, Ana S. Cruz Solbes, Barry Trachtenberg, Ashrith Guha, Arvind Bhimaraj; Houston Methodist Hospital, Houston, TX
318 Impella 5.0 as a Bridge to Clinical Decision Making Daniel Nelson, Asim Mohammed; Medical College of Wisconsin, Milwaukee, WI Introduction: Mortality from cardiogenic shock remains a significant clinical challenge. Short term mechanical circulatory support devices have the potential to improve outcomes. The Impella 5.0 is currently FDA approved for up to 10 days. We report our institutional experience with the Impella 5.0 as a means to improve survival and expand
Introduction: We had previously published a percutaneous technique of axillary intra-aortic balloon pump (IABP) placement in patients being bridged to transplant for facilitation of ambulation and physical recovery. However, this enhanced mobility of the patient may predispose to a higher risk of IABP malposition with unique complications compared to the non-ambulatory state of femoral IABP therapy. We present our experience to illustrate this. Methods: We conducted a retrospective chart review of patients that received percutaneous axillary IABP at our hospital from October 2015 to February 2018. Results: A total of 75 patients had percutaneous axillary IABP insertion during the study period. Of these, 2 had gross IABP malposition into the arch of aorta and 5 patients had superior mesenteric artery (SMA) occlusion by IABP. Table 1 describes the specifics of these patients. Conclusion: There has been a wealth of experience with femoral IABP use wherein the malpositions
S120
Journal of Cardiac Failure Vol. 24 No. 8S August 2018 Table 1. Results. Total duration of IABP support (days)
Initial manifestation of malposition
Imaging
Sudden onset abdominal pain, signs of peritonitis and leucocytosis Abdominal pain, nausea, vomiting
Abdominal CT scan: pneumatosis coli (Image 2) with portal venous gas (Image 3) Abdominal CT scan: IABP tip and distal segments in SMA
On-going
Abdominal discomfort
Abdominal CT scan: mesenteric ischemia, IABP tip in SMA
ESHF: BTT
22
Abdominal CT scan: distal IABP marker in SMA
34
Fluoroscopy: IABP tip in SMA
IABP repositioned
Male
ESHF: Bridge to decision (BTD) ESHF: BTD
IABP alarms; Chest X-ray showed IABP proximal marker at T2 verteberal level. Abnormal arterial wave-form
Fluoroscopy: IABP coiled in aorta
IABP exchange
Male
ESHF: BTT
27
Chest X-ray: IABP markers at T5 and T6 vertebral levels respectively (Image 1). Abdominal Xray showed no IABP marker Chest X-ray: IABP markers at T5 and T9 levels respectively (Image 4). Abdominal X-ray showed distal IABP marker at T9 level.
Fluoroscopy: IABP proximal end was bent and flopped over itself into ascending aorta
IABP exchange
Indication for IABP
Patient
Age (years)
Sex
A
51
Male
Refractory unstable angina
9
B
53
Male
13
C
58
Male
End-stage heart failure (ESHF): Bridge to transplant (BTT) ESHF: BTT
D
66
Male
E
70
Male
F
65
G
56
27
Management and outcome Emergent right hemicolectomy IABP exchanged, abdominal pain resolved IABP repositioned, abdominal discomfort resolved IABP exchange
described above have not been reported. As utilization of IABP in the axillary position to promote ambulation is increasing, it is imperative to understand and expect such unique complications for prompt diagnosis and management.
Image 3. (Patient A): Abdominal CT scan showing portal venous gas.
Image 1. Chest X-ray of Patient F (Yellow arrows pointing to the IABP markers).
Image 4. Chest X-ray of Patient G (yellow arrows pointing to the IABP markers). Image 2. (Patient A): Abdominal CT scan showing pneumatosis coli.