Brian Clarke MD FRCPC FACCAssociate Professor, University of Calgary, LibinCardiovascular Institute

THE NUTS AND BOLTS OF REAL WORLD IMPLANTABLE HEMODYNAMIC MONITORINGHEART FAILURE UPDATE 2019 Brian Clarke MD FRCPC FACCAssociate Professor, University of Calgary, LibinCardiovascular Institute Disclosures•Grants/research support: None•Consulting fees: •Speaker fees: Novartis, Servier, ABBOTT•Other: None Background•Burden of heart failure is well known to this audience (as is the cost)•Modest prognostic improvement over the years•>$2.8 billion/year1•The cost, morbidity and mortality of HF are intimately linked to hospitalizations 1,2•Hospitalizations represent the most severe form of decompensation and rehospitalization rates remain high•>90% of hospitalizations arise due to congestion1 1.Heart and Stroke Foundation of Canada: 2016 Report on the Health of Canadians2.Circulation Heart Failure 2014;7(4):590-595 Decompensation Events Requiring More Intensive Therapy are Associated with Higher Mortality Risk Okumura N, et al. Circulation, 2016;133:2254-2262. No EventIntensification of Therapy Emergency Department Visit Heart Failure Hospitalization All decompensation events were associated with a statistically significant increase in mortality risk. All Cause Death Kaplan-Meier cumulative mortality curve all-cause mortality after each subsequent hospitalization for HF. Long-term Mortality Risk Increases with Multiple Hospitalizations SetoguchiS, Stevenson LW , SchneeweissS, Am Heart J, 2007;154:260-264. 1st admission(n = 14,374) 2nd admission(n = 3,358) 3rdadmission(n = 1,123) 4th admission(n = 417) Physical examination: low sensitivity, late signsWeight & symptoms or blood pressure:•TELE-HF trial: no effect on HF hospitalizations•Telephone based voice response system with higher risk population than TIM-HF•Adherence was poor•TIM-HF trial: no effect HF hospitalizations•Bluetooth enabled device following BP, weight, 3-lead ECG•Low risk HF populationIntrathoracic impedance (optivol):•DOT-HF trial: increase in HF hospitalizations Prior attempts of remote-monitoring in HFTRIALN PARAMETER MONITOREDIMPACT ON HF HOSPITALIZATIONJOURNAL TELE-HF1 1,653Signs/symptoms,daily weightsNoneThe New England Journal of Medicine, 2010TIM-HF2 710Signs/symptoms,daily weightsNoneCirculation, 2011 TEN-HMS3 426Signs/symptoms,daily weights, BP, nurse telephone supportNoneJournal of the American College of Cardiology, 2005 BEAT-HF4 1,437Signs/symptoms,daily weights, nurse communicationsNoneAmerican Heart Association, 2016 INH5 715Signs/symptoms,telemonitoring, nurse coordinated DMNoneCirculation Heart Failure, 2012DOT-HF6 335Intrathoracic impedance with patient alertIncreasedCirculation, 2011 Optilink7 1,002Intrathoracic impedanceNoneEuropean Journal of Heart Failure, 2011REM-HF8 1,650Remote monitoring via ICD, CRT-D or CRT-P NoneEuropean Society of Cardiology, 2017 MORE CARE9865Remote monitoring of advanced diagnostics via CRT-D NoneEuropean Journal of Heart Failure, 2016 Total8,793 •1. Chaudhry SI, et al. N Engl J Med, 2010.•2. Koehler F, et al. Circulation, 2011.•3. Cleland JG, et al. J Am Coll Cardiol, 2005. •4. Ong MK, et al. JAMA Intern Med, 2016.•5. Angermann DE, et al. Circ Heart Fail, 2012.•6. van Veldhuisen DJ, et al. Circulation, 2011.•7. Brachmann J, et al. Eur J Heart Fail, 2011.•8. Cowie MR, ESC,2016.•9. Boriani G, et al. Eur J Heart Fail, 2016. The way forward in telemonitoring is to target hemodynamic congestion instead of clinical congestion Adamson PB, et al. Curr Heart Fail Reports, 2009. CHAMPIONDOT-HFTELE-HFTIM-HF PATIENT CALLS PULMONARY ARTERY PRESSURE MONITORING -Electrical resonance circuit –sensor measures PA pressure-Distension of the membrane corresponds to a pressure shift (sPA, dPA)-No wires or battery-Inserted via right heart cath-Ideal target is left lower/posterior pulmonary artery-Minor complications comparable to right heart cath-Completely endothelializeswith ASA/Plavix x 1 month, then ASA-Systemic anticoagulation held and restarted (no ASA,Plavix) CHAMPION Clinical Trial: PA Pressure-guided Therapy Reduces HF Hospitalizations Abraham WT, et al. Lancet, 2011 Abraham et al., Lancet 2016 PA monitoring reduced HF hospitalizations by 37% (p<0.001) at mean 15 months follow –upNNT = 4MLWHF >5 point reduction treatment in the post-implant period. Related data from the first 2,000 commercial PAP sensor implants (including both Medicare and non-Medicare patients) do suggest that PA pressure reductions achieved in clinical practice are even greater than those seen in the pivotal CHAMPION trial (17),a n dc h a n g e si nP A Pa p p e a r to be tightly linked to clinical outcomes (25).O v e r a l l , therefore, it seems reasonable to infer that the reduc- tion in HFH is, in at least some measure, related to ac- tion taken by clinicians in response to PAP sensor data. Despite FDA approval, t here has been an ongoing dispute regarding the ef ficacy of hemodynamic monitoring, principally due to concerns regarding the design of the pivotal trial (26).A sw e l l ,d u r i n gt h e initial FDA review of the CHAMPION data, concerns were raised about a possible variation in the bene fito f hemodynamic monitoring according to sex, as women in the treatment arm had a numerically greater (but statistically nonsigni ficant) rate of HFH than those in the control arm (27).T h eM e d i c a r e cohort sampled for this study is nearly 4 /C2the size of the CHAMPION trial treatment arm, and includes a larger proportion of women (40% vs. 23%) and elderly subjects (mean age 71 years vs. 61 years; 40% over 75 years of age). Data from this broader patient sam- ple reinforce the CHAMPION results by highlighting a numerically greater reduction in HF hospitalizations at 6 months than that seen in the trial, and provide reassurance that these bene fits are consistent across key subgroups of interest. Although this is not a form al cost-effectiveness analysis, these data regarding device utilization in the commercial setting do provide some important assurances regarding the economic implications of ambulatory hemodynamic monitoring. First, observed rates of device utilization in the Medicare population are far lower than those that drove early projections of the potentially large budgetary effect of device approval (28).S e c o n d ,t h eo b s e r v e dr e d u c t i o ni n hospitalizations following device implantation is CENTRAL ILLUSTRATION Cumulative HFHs During the Period Before and After Pulmonary Artery Pressure Sensor Implantation 0 0 200 400 HR 0.55, 95% CI (0.49-0.61) p<0.001 HR 0.66, 95% CI (0.57-0.76) p<0.001 600 800 1000 Cumulative HF Hospitalizations 700 600 500 400 300 200 100 0 Cumulative HF Hospitalizations -1mo -2mo -3mo -4mo -5mo -6mo 0Post-implant: Pre-implant: 1mo 2mo 3mo 4mo 5mo 6mo 1114 1114 1114 1114 1114 1114 1114 1114Post-implant Pre-implant Number at risk 1080 1049 1019 1002 976 955 0 -2mo -4mo -6mo -8mo -10mo -12mo 0Post-implant: Pre-implant: 2mo 4mo 6mo 8mo 10mo 12mo 480 480 480 480 480 480 480 480Post-implant Pre-implant Number at risk 450 435 409 394 373 357 AB Pre-implant HFH Post-implant HFH Desai, A.S. et al. J Am Coll Cardiol. 2017;69(19):2357 –65. (A)6-month cohort. (B)12-month cohort. Hazard ratios were derived using the Andersen-Gill extension of the Cox proportional hazards model, accounting for the competing risk of death, ventricular assist device, or transplant. Note that event accumulation during the pre-implant interval is counted backwar d from the time of implant. Data highlight signi ficant reductions in cumulative HFHs in the period after device implantation compared with the period before implantation for both the 6- and 12-month cohorts. CI ¼confidence interval; HF ¼heart failure; HFH ¼heart failure hospitalization; HR ¼hazard ratio. Desai et al. JACC VOL. 69, NO. 19, 2017 HFH Reductions With PAP Monitoring MAY 16, 2017:2357 –65 2362 Downloaded for Anonymous User (n/a) at University of Calgary - Canada Consortium from ClinicalKey.com by Elsevier on April 30, 2019. For personal use only. No other uses without permission. Copyright ©2019. Elsevier Inc. All rights reserved. 1114 Medicare patients Ambulatory hemodynamic monitoring added to standard care reduces HFHReal world safety and effectiveness comparable to trial dataFurther validates clinical trial evidence -45%6 months-34%12 months CardioMEMSReal World Data Desai et al. JACC 2017;69(19) 2357-2365 CardioMEMS™ HF System Overview 120cm4.5cm Patient and Hospital Electronics System PA Pressure Sensor on Catheter Delivery System Merlin.net TM Patient Care NetworkAim: Maintain normal mean PA 10-25mmHg + euvolemiastateAddress accordingly with diuretics or vasodilators sPAdPAmPAPA trendHeart rateAdherence IMPLEMENTING a CardioMEMS™ HF System program:Patient SelectionIdentify patients most likely to benefit.123 NYHA IIIIRRESPECTIVE OF LVEFClinical congestionPrevious HF hospitalization ALSO CONSIDER…..Need to respond to diureticsNeed to have blood pressure to work withNeed to be compliant and adherentAvoid Stage D Heart failure -“end stage” Health Canada Inclusion•NYHA III chronic HF on maximally tolerated medical therapy•HFpEFand HFrEFeligible; no LVEF requirement•Hospitalization for HF in past 12 monthsConsiderations•Ideally >2 hospitalizations in past 12 months•Frequent outpatient diuretic adjustments (>2 per month for 3 consecutive months)•Frequent decompensationsrequiring outpatient IV diuretics•Difficult clinical volume assessment•Geographic limitations impacting clinic access Calgary Invasive Heart Failure Monitoring Program Exclusion•eGFR< 25ml/kg/m2•Contraindication to Plavix + ECASA•Health illiteracy•History of non-compliance•Inability to meet home technology requirements for remote transmission•Active infection•Recurrent PE •Unable to tolerate right heart catheterization•Mechanical right heart valves•Known coagulation disorders•Recent implant CRT +D (<3months)•Chest circumference >165cm (axillary level)•Numerous retained pacemaker leads Calgary Invasive Heart Failure Monitoring Program IMPLEMENTING a CardioMEMS™ HF System program•Identify Implant Workflow•Where •Heart Function Clinic at Foothills Medical Centre•All nurses educated•What:•Pre procedure education visit, consent procedure, baseline assessments•QoL, 6MWT, financial assessment, labs, CXR•Anticoagulation assessment•Cath Lab Team trained and dedicated. Post procedure patient education and transmission•Nurses and MD monitor pressures MERLIN.net•Baseline RHC to correlate PAdto PCWP •Optimization Phase•Medication adjustments to achieve target PA pressures•Diuretics, vasodilators•HF nurses contact patient with medication changes, arrange weekly labs during this phase•Daily assessment of pressures/ Treat trends over 3 days•Weekly team communication•PA pressures incorporated into HF nurse workflow •Target Goal PA Pressures:§PA Pressure Systolic 15 –35 mmHg§PA Pressure diastolic 8 –20 mmHg§PA Pressure mean 10 –25 mmHg •Maintenance Phase•Prespecified PA range can be set to deliver email notification ONLY when PA readings fall outside a certain range•Algorithms for nurse led management can be developed 34F with Shone syndrome •Patch aortoplastyfor coarcationage 5•Bicuspid normally functioning aortic valve•Mechanical MV replacement September 2015 (UAH) –mitral stenosis•MVR 23mm On-X mechanical valve •DysmorphousMV , hypoplasticaorta, well functioning bicuspid aortic valve•Paroxysmal Atrial fibrillation•Obesity•Presented to Calgary transplant group for Heart Transplant, Heart/Lung•CPET submaximal: VO2 12ml/min/kg VE/VCO2 slope 50•TTE July 2018 LVEF 40% LVEDD 41mm, MV P/M gradients 33 / 9, PHT normal, HR76bpm, PHT, mild-mod RV dysfunction•Level 3 sleep testing–OSA confirmed –initiated CPAP •Severe pulmonary HTN on previous cath R+L with NO June 29 2018 PA 87/35/54mmHgPCWP 32/40/32mmHgRA 18/17/16mmHgCO 4.26L/min CI 2.16L/min/m2(F) 3.83L/min CI 1.94L/min/m2(TD)TPG 22 PVR 5.16 (F) 5.74 (TD)SVR 1671 dynes*s*cm5MV gradient : 11mg, MV A 1.16cm2LVEDP 32mmHg 40ppm NOPA. 81/36/50mmHgPCWP 41/71/42mmHgCO/CI(TD) 3.96L/min CI 2.01L/min/m2TPG 8 (owing to severely elevated PCWP)PVR 2.02WUBP128/64(88) mmHg80ppm NOPA 68/30(41)mmHgPCWP 40/68/40mmHgCO/CI(TD) 3.48L/min CI 1.77L/min/m2TPG 1PVR <1WUBP 132/62(89) mmHg •Outpatient attempts at oral therapy optimization •LVEF 40%, occluded Circumflex artery identified (likely occurred during surgery 2015) •Symptoms improved from NYHA IV –NYHA III •Progress stalled after 2 weeks and admitted to hospital for inpatient treatment •Admitted August 7 2018 Management options being considered1) Heart Lung TransplantationYoung, VO2 concerning, PHTNSeemed a little aggressive this early on2) MV excision with LV AD placementSmall ventricleBTC by reducing pulmonary pressures?Seemed a little aggressive this early on3) Continue attempts at medical optimizationIs this MV really a problem??? +++LVEDP, LVEF 40% by echoIs this all heart failure?? •CardioMEMSimplant September 7 2018•PA: 65/29(43) mmHg•PCWP 27/38/27 mmHg•RA 14/12/10 mmHg PAdis the target for therapy with CardioMEMStherefore correlation with PCWP at implant RHC is important in management goals •CardioMEMSenables frequent medication changes •Individualized therapy•ACEi, Entrestodidn’t improve much•Stalled on Lasix, spiro, zaroxlyn•Responded to nitrates, bumetanide, zaroxlyn, spironolactone•Email communication with no clinic visits in 7 months •NYHA II from NYHA IIIB•50% reduction in PA pressures•VO2 max 12ml/min/kg VECO2 50 –May 2018•VO2 max 14.7ml/min/kg VEVCO2 36 –January 2019•VO2 max 15.5 ml/min/kg VEVCO2 33 –May 2019•Requires massive doses of diuretics•May 2019•Coreg 12.5mg BID•IMDUR 240mg BID•Bumex 2mg BID EOD, 3mg/2mg EOD•Zaroxlyn2.5mg EOD•Spironolactone 50mg BID •Restrictive CM related to her underlying congenital disease What we learned in 7 months 2019-04-30, 3*30 PMMerlin.net™ PCN Page 1 of 1https://merlin.net/group/merlin-hf_b/trendgraph?patientId=50829655&pressure=1&patientTreatingClinic=1&deviceProductId=0#hfCharts Signed in as B Clarke Sign Out Show Medications Merlin.net™ Patient Care Network - Heart Failure Management PatientsDrugsMedical ConditionsAdministration 35 yo , Phone 1-403-6204588 Kotelko, Michelle Priority Subscribed PA Diastolic Pressure Threshold: Lower 10 mmHg, Upper 20 mmHg Right Heart Cath Implant Values FixedAuto Date Range:30 daysFrom: 08-30-2018 To: 05-03-2019 PA Metrics and EventsPA SystolicPA Systolic TrendPA MeanPA Mean TrendPA DiastolicPA Diastolic TrendHeart Rate from PA SensorMedicationsSuspect Readings MNNN NNNN NN NNNN NS09-201810-201811-201812-201801-201902-201903-20190 20 40 60 80 100mmHg 05-201807-201809-201811-201801-201903-201905-201907-201909-2019 Website Terms of Use|Clinic Terms and Conditions|Privacy Policy|Contact Us|sjmprofessional.com Merlin.net™ © 2019 St. Jude Medical Help▼ BumetanideAcute Renal Failure •73year old female•Afib, Hypothyroid, HTN, dyslipidemia, nonsmoker, no DM, no known CAD•GI Bleed with NOAC (GI angiodysplasiaon colonscopy)•Bronchiectesis2018 with pseudomonas on bronchoscopy•OSA intolerant to CPAP•Active independent complaint patient•Lives in assisted living, drives and travels with her ‘girls club’•HFpEFdiagnosed June 2016•SOB, clinical congestion with JVD•Echo•Normal LV systolic function•Mild LVH (septum 12mm). LV Mass 101.2g/m2•RV normal•No structural heart disease Patient JL •3 episodes of congestion in 2017 requiring intensification of diuretics •1 requiring outpatient IV •HR controlled by Holtermonitor •Persistent NYHA III symptoms 2018 •DC cardioversionfor AfibMarch 2018•No effect on symptoms•Afibrecurred 9 weeks later, left alone •Pulmonary investigation for SOB/AbnCXR•Bronchiectesiswith resultant moderate obstructive lung dz •DOAC stopped due to recurrent GI bleeding •Hospitalized May 2018 for ADHF Patient JL PA: 55/22(36)mmHgPCWP: v25mmHg, mean18mmHgRV: 58/3mmHg (edp7)RA: 8mmHgCO: 4.3L/min CI: 2.5L/min/m2TPG: 18 PVR 4.18WU •Plavix and ASA x 1 month –no GI bleeding CardioMEMSimplant September 7 2018 Spiro 25Spiro 50M 2.5 x 1 doseDiltiazem240OD 2018-11-15, 11:37 PMMerlin.net™ PCN Page 1 of 1https://merlin.net/group/merlin-hf_b/readings Signed in as B Clarke Sign Out Readings ◄◄◄◄ ◄◄ Current Month ►► ►►►► Approved Readings Ignored Readings Suspect Readings No Readings Merlin.net™ Patient Care Network - Heart Failure Management PatientsDrugsMedical ConditionsAdministration 73 yo , Female , Phone 1-403-3750700 Lemay, Joyce Priority Subscribed Dec '17Jan '18Feb '18Mar '18Apr '18May '18Jun '18Jul '18Aug '18Sep '18Oct '18Nov '18 Showing 21 - 30 of 75 Show 10 per page 10-27-2018, 08:00 AM57 mmHg 28 mmHg 40 mmHg 96 bpm 10-26-2018, 09:10 AM53 mmHg 27 mmHg 38 mmHg 104 bpm 10-25-2018, 08:55 AM48 mmHg 26 mmHg 35 mmHg 114 bpm 10-24-2018, 07:31 AM52 mmHg 27 mmHg 38 mmHg 114 bpm 10-23-2018, 08:17 AM47 mmHg 26 mmHg 35 mmHg 104 bpm 10-22-2018, 07:54 AM49 mmHg 26 mmHg 35 mmHg 108 bpm 10-21-2018, 09:43 AM47 mmHg 24 mmHg 34 mmHg 107 bpm 10-20-2018, 09:37 AM51 mmHg 26 mmHg 36 mmHg 93 bpm 10-19-2018, 08:50 AM47 mmHg 25 mmHg 34 mmHg 111 bpm 10-18-2018, 08:24 AM47 mmHg 25 mmHg 34 mmHg 107 bpm Taken on PA Systolic PA Diastolic PA Mean Heart Rate ◄◄◄...234...►►► Website Terms of Use|Clinic Terms and Conditions|Privacy Policy|Contact Us|sjmprofessional.com Merlin.net™ © 2018 St. Jude Medical All ▼ Search Help▼ Cough, tired, SOB Infiltrate on CXRTreated with Ax éM 2.5 x 1 dose 2019-04-30, 3*40 PMMerlin.net™ PCN Page 1 of 1https://merlin.net/group/merlin-hf_b/trendgraph?patientId=50829657&pressure=1&patientTreatingClinic=1&deviceProductId=0#hfCharts Signed in as B Clarke Sign Out Show Medications Merlin.net™ Patient Care Network - Heart Failure Management PatientsDrugsMedical ConditionsAdministration 74 yo , Female , Phone 1-403-3750700 Lemay, Joyce Priority Subscribed PA Diastolic Pressure Threshold: Lower 15 mmHg, Upper 25 mmHg Right Heart Cath Implant Values FixedAuto Date Range:30 daysFrom: 09-04-2018 To: 05-01-2019 PA Metrics and EventsPA SystolicPA Systolic TrendPA MeanPA Mean TrendPA DiastolicPA Diastolic TrendHeart Rate from PA SensorMedicationsSuspect Readings M MMNN NNNN NNN N NNN NNSSSS S SSSS SS 09-201810-201811-201812-201801-201902-201903-20190 20 40 60 80 100mmHg 05-201806-201807-201808-201809-201810-201811-201812-201801-201902-2019 Website Terms of Use|Clinic Terms and Conditions|Privacy Policy|Contact Us|sjmprofessional.com Merlin.net™ © 2019 St. Jude Medical Help▼ M 2.5 x 1M 2.5 x 1 NYHA II from NYHA IIINo clinical decompensations in 7 months Much to Learn…and Work Through-Takes the guess work out of things-Personalize/tailor/individualize heart failure therapies-Great opportunity to provide heart failure care to geographically remote/underserviced patients/areas-Great for challenging patients-Difficult volume assessment, highly symptomatic with confirmed congestion, the cloud of comorbidities-Perhaps the only intervention thus far demonstrating benefit for HFpEF-COMPLIANT PATIENTS ARE KEY •Unlikely to be beneficial to a broad population of HF patients •Stable patients benefit?•Cost!! Preventing HF hospitalizations may not be attractive business case. •“if a HF patient isn’t in the bed, someone else is”•Expensive technology that is difficult to afford in our system•More outcomes data is needed•How best to incorporate this in the Canadian Context Benefits of PA pressure monitoring -Clearly improves HF managementHemodynamic congestion precedes clinical congestionObjective information to help tailor and individualize therapyEffects of therapy can be seen within daysPatient engagement and self care-Pressure feedback changes your practice-Cost. Everything’s expensive with fixed hospital budgets/Difficult administrative challenge. “If your heart failure patient isn’t in that bed, another patient is….” Patient outcomes are priority. -Who will MOST benefitRemote Monitoring applied broadly to a patient population is unlikely to be beneficial (and certainly not cost-effective)RPM should be:1) targeted to at risk patients 2) used to directly improve patient care-We need to work together to integrate this technology into our healthscapefor the -betterment of our patients CardioMEMSin the Canadian Context THANK YOU!