ENDEAVOR Long term clinical outcome

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ENDEAVOR Long term  clinical outcome Powered By Docstoc
					 Noninvasive Home Monitoring of
 Pulmonary Artery Pressure by the
RemonCHF Device: First Multicenter

     Prof. Yoseph Rozenman* and the
         PAPIRUS-2 Investigators

        *E. Wolfson Medical Center and
      Remon Medical Technologies - Boston
                Scientific, USA

                         ICI, December 2007, Tel-Aviv
 Despite the advance in medical therapy patients with
  CHF suffer from frequent episodes of decompensation
  that require hospital admission

 Most episodes of CHF decompensation are due to
  dyspnea with an increase in left side filling pressure

 An initial asymptomatic rise of filling pressure might
  occur days to weeks before symptoms and
 Modern care of CHF utilizes disease management
  programs that emphasize monitoring of patients’
  condition so that treatment can be optimized in the
  outpatient setting and hospitalizations can be

 PA diastolic pressure is a clinically useful
  surrogate of LV filling pressure and is thus an
  attractive parameter to monitor in these patients
   Acoustic Telemetry: A marriage of
   medical and underwater technologies
• Acoustic waves propagate
  well in the body
• Used extensively in medical
• Safe even at high levels
• Established techniques for
  communication in
  underwater acoustics

 Very attractive for wireless communication
 systems within the human body
                               JACC, 2007; 49 :784-789

Initial experience with first generation of the
device demonstrating feasibility safety and
accuracy of measurement in animals and in 10
patients with CHF
Device implantation is achieved by simple Rt. heart
catheterization procedure
Implant is advanced to the desired site of implantation
using a delivery sheath and is released like a self
expandable stent

Pulmonary angiogram         Implant released in the PA
                            Sensor stabilized with an anchor
   Pulmonary Artery Pressure
Millar compared to Remon’s Implant at
       implantation (animal data)
       PAPIRUS 2: Objective

To evaluate the safety, feasibility and
clinical utility of a second generation
RemonCHF device

Second generation device includes
an implanted battery enabling simple
home monitoring of PA pressure
         Remon* ImPressureTM pressure-
              monitoring system
   Miniature implant:
   Pressure sensor capable of
    measuring absolute pressure
   Self-expandable articulated anchor

  Hand-held unit:
  Acoustic energy is used for
  communication with the sensor
  Transformation to gauge pressures by
  embedded barometer
  Displays diastolic PA pressure

* Now part of Boston Scientific
 Multicenter, prospective, nonrandomized clinical study

 Patients with CHF in NYHA class III-IV

 Implantation of the Remon ImPressureTM device in the
  right PA to obtain full pressure waveform of 10s

 Pressure measurement accuracy is determined by
  comparing of implant reading to Millar pressure wire at 6

 Patients’ are provided with a hand-held home units for
  daily self-monitoring at home
Home Monitoring

        Complete PA pressure
        waveform is recorded for
        10sec and is available for

        Pa diastolic pressure
        and heart rate are
        displayed for the patient

        Data is collected once,
        twice (or more) daily (as
Results: Baseline Demographics
Number                                40
Age (yr)                           65 ± 15
Male sex (%)                      28 (70%)
NYHA class III/IV (%)         39/1 (97.5/2.5%)
Pulmonary hypertension (%)         8 (20%)
Medical history of
hypertension (%)
History of myocardial
                                14 (35.0%)
infarction (%)
Coronary artery disease (%)     21 (52.5%)
Diabetes mellitus (%)           13 (32.5%)
    Results: Implantation & Safety

Permanent implantation in 31 patients out of 40 patients
  9 pts. with unsuitable PA anatomy (diameter and/or shape)

Safety endpoints:
 18 adverse events in 12 patients
 2 adverse events related to implantation:
              -Contrast allergic reaction
              -Prolongation of hospitalization for device

Deployment rating:
   Investigators‘ rating of ease of delivery/deployment:
            -22 excellent; 9 good
         Accuracy and Functionality
 Repeated measurements successful in 30 patients
 Offset compared to Millar wire 1.7 mmHg (95% CI, 3 to 6.4 mmHg)

                                                Bland Altman Plot:
                                                Implant vs. Millar
               Home monitoring

 24 patients received hand-held home units

 5600 successful home measurements

 Median compliance with daily monitoring 88%

 Daily variation of diastolic PA pressure: 1.6 – 3.4mmHg

 Trends of PA diastolic value are constructed to assess
  hemodynamic condition over time
PA diastolic pressure trend over
                                  PA pressure curve

                                  PA diastolic trend

Stable values during follow-up   Estimated CO trend
     PA pressure at different patient postures &
   PA pressure dropped         PA pressure unchanged
    supine vs. standing
           (6.4±3.4 mmHg)
                                      at high altitude

                            34 mmHg

                                      High Altitude

                            26 mmHg
     Decompensation and response to therapy


                      Non-compliance with
                        medical therapy

Response to therapy
      Persistent high pulmonary diastolic

 Persistent high

                                    Onset of AF


No response to
              Pulmonary Hypertension
      Effect of Bosentan therapy and withdrawal

                                        PA Pressure 84/34 mmHg

                      Fluid overload:
 Diastolic Pressure
 No bosentan:
Poor compliance

 Pulse Pressure

                       15mmHg increase in diastolic PA pressure
                       20mmHg increase in Pulse PA pressure
bosentan               35mmHg increase in systolic PA pressure
      Effect of CRT

             Response to Carvedilol

Carvedilol 12.5 mg
 Detection of atrial fibrillation

  3 days AF
         Possible Mode of Use


CHF Center
 Home monitoring of PA pressure using wireless acoustic
  communication is feasible and safe

 Recorded PA pressures are reliable and accurate

 Patients’ compliance with self monitoring is very good

 Recorded PA pressures show response to therapeutic

 Daily PA pressure monitoring might be helpful in guiding
  long-term management in CHF
    reduces decompensation events and hospitalization
Thank You