Nuwellis, Inc. · NASDAQ:NUWE
Nuwellis — Sunshine Heart — Transcatheter Cardiovascular Therapeutics (TCT) 2013
26 slides from Nuwellis's conference presentation, Oct 29, 2013
Slide 1: Can C-Pulse Use Lead To Left Ventricular Recovery?
Can C-Pulse® Use Lead To Left Ventricular Recovery? Andrew Kao, M.D., F.A.C.C. Associate Professor of Medicine University of Missouri-Kansas City Transcatheter Cardiovascular Therapeutics San Francisco, CA October 29, 2013
Slide 2: Disclosures
Disclosures .Presentation based on data from single center experience (St. Luke’s Mid America Heart Institute, Kansas City, MO) - C-Pulse® feasibility study .Caution: C-Pulse® is an investigational device. This device is limited by federal (US) laws to investigational use only
Slide 3: Proposed Treatment Algorithm for Advanced HF
Proposed Treatment Algorithm for Advanced HF Adapted from Stevenson LW et al. J Heart Lung Transplant 2009;28:535-541 Interagency Registry of Mechanically Assisted Circulatory Support OHT DT C-Pulse® Profile Description 1. Critical cardiogenic shock 2. Progressive decline on inotropic support 3. Sta
Slide 4: Advantages of C-Pulse Therapy
Advantages of C-Pulse® Therapy .Easy to manage – “On-Off” concept .Cardiac assist device, not life-sustaining .Extravascular device – no need for anticoagulation .May be performed via mini-thoracotomy – faster recovery period
Slide 5: C-Pulse Week
C-Pulse® 1 Week
Slide 6: Likelihood of Ventricular Recovery
Likelihood of Ventricular Recovery 0 5 10 15 20 OHT VAD MAHI C-Pulse® Additional 33% partial recovery INtERMACS Quarterly Statistical Report 6/13
Slide 7: Tales of Recovery
Tales of Recovery Ui? Saint Luke’ Mid America ‘Heart & Vascular Institute & [uy Psaiai tunis atatie sisital
Slide 8: #1 Patient history
Patient #1 .45 yo man with 10 year history of familial dilated cardiomyopathy .History of DVT/PE but intracranial hemorrhage from coumadin – thus not VAD candidate .Cannot walk more than a few feet .Prescribed oxygen by local MD .Hemoptysis due to pulmonary edema .Diffusely diaphoretic
Slide 9: #1 Hemodynamics and implantation
Patient #1 .Echo LVEF 10% .8/10 Right heart cath – RA 7, PA 52/23/34, PCWP 14, CO/CI 4.1/1.7 .8/10 C-Pulse® implantation .Discharge postop day 4 .1 month visit – walked around air show 3- 4 hours! – NYHA I since then .6 month RHC – RA 10, PA 35/13/23, PCWP 13, CO/CI 5.9/2.7
Slide 10: #1 Follow-up and explant
Patient #1 .9 months – asked for Cialis .1 year echo – LVEF 20% .2 year echo – LVEF 21% .Preop – 140 mg Lasix a day .5 months postop to now – no Lasix .12/12 (28 months) – PIL explant .Remains NYHA I
Slide 11: #1 C-Pulse Usage
Patient #1 C-Pulse® Usage 0 20 40 60 80 1 3 6 12 18 24 28 Months % Use
Slide 12: #1 - Lessons
Patient #1 - Lessons .Patient clearly INTERMACS profile 4 at baseline .Hemodynamics significantly improved by 6 months (60% improvement in cardiac index) .No diuretic requirement since 5 months .“Cialis” at 9 months .11% usage at 1 year .Successful PIL explant 28 months
Slide 13: #2 Patient history
Patient #2 .36 yo with 10 year history of LBBB .Finally diagnosed with HF 3 years prior .Echo LVEF 21% .Effort limitation at 3 blocks .Too well for OHT .Peak VO2 19 ml/kg/min, 42% of predicted
Slide 14: #2 Implantation and outcome
Patient #2 .Recently completed second master’s degree .Wanted to do anything possible to regain quality of life and return to work force .NYHA class III .Intermacs profile 7 .C-Pulse® placement 4/12 .Postop fevers ? Pericarditis .Discharge POD 7 .Pre discharge echo EF 45%!
Slide 15: #2 Compliance and weaning
Patient #2 .Excellent compliance 75-85% .7/13 – PIL issue necessitated C-Pulse® off for 48 hours – no symptoms .8/13 Stable on C-Pulse® 1:1 – given stability, decreased to 1:2 .9/13 Stable on 1:2 – no symptoms - C-Pulse® turned off .10/13 Follow up echo pending – asymptomatic off C-Pulse®
Slide 16: #2 Serial LVEFs
Patient #2 Serial LVEFs 0 10 20 30 40 50 Pre 0.25 1 15 16 17 Months Off x 48 hrs 1:2 x 1 month
Slide 17: #2 - Lessons
Patient #2 - Lessons .Patient clearly INTERMACS profile 7 at baseline – HF treated 3 yrs prior but probably present for 10 yrs .Significant sustained improvement of LVEF by 7 days postop .Gradual “wean” 1:1 to 1:2 without symptoms .Serial echos during weaning process showed no change of LVEF
Slide 18: #3 Patient history
Patient #3 .61 yo man s/p anterior STEMI 7/01 – LAD drug-eluting stent .Post MI LVEF 30% .LVEF 20% 2007 – ICD placement .2/10 – LLL nodule – biopsy non small cell, negative metastatic workup .LLLobectomy .Incidental finding of bronchoalveolar cell CA LUL s/p resection .No adjuvant therapy
Slide 19: #3 Worsening heart failure
Patient #3 .5/10 worsening HF .90 degree orthopnea .Worsened renal function with diuresis .Milrinone begun – immediate improvement .2 weaning attempts failed within hours – recurrent 90 degree orthopnea, oliguria, elevated creatinine .Home inotropes begun with stability .Patient is clearly INTERMACS
Slide 20: #3 C-Pulse placement
Patient #3 .Insurance would not pay for LVAD .Right heart cath on milrinone – RA 8, PA 39/21/26, PCWP, CO/CI 4.3/2.2 .8/10 C-Pulse® placement after 3 months of inotropic dependence .Milrinone weaned off 2-3 hours postop after extubation .6 month RHC – RA 7, PA 47/25/31, PCWP 10, CO/CI 4.2/2.2
Slide 21: #3 Current status
Patient #3 .Currently NYHA II .Has not required inotropes .Several admissions for COPD only .Long smoking history .Lung resection .Patient felt well enough to “self-wean” soon after 30 day time point
Slide 22: #3 C-Pulse Usage
Patient #3 C-Pulse® Usage 0 20 40 60 80 1 3 6 12 18 24 30 36 Months % Use
Slide 23: #3 LVEF
Patient #3 LVEF 0 10 20 30 40 0 3 12 30 36 Months LVEF (%)
Slide 24: #3 - Lessons
Patient #3 - Lessons .Patient was clearly INTERMACS level 3 .C-Pulse® placement had same sustained hemodynamic effect as milrinone in this case .Decrease in C-Pulse® usage suggests improvement in cardiac function .C-Pulse® placement has helped him maintain HF stability for 3+ years
Slide 25: Conclusion
Conclusion .C-Pulse® implantation feasible via minimally invasive right thoracotomy .Weaning of C-Pulse® support feasible after varying duration of hemodynamic support, with the potential for PIL explantation .Further investigation will be necessary to confirm these single center observations
Slide 26: Video
Patient Video
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