ENDEAVOR Long term clinical outcome

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

     Prof. Yoseph Rozenman* and the
         PAPIRUS-2 Investigators

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

                         ICI, December 2007, Tel-Aviv
                Background
 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
  hospitalization
                Background
 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
  prevented

 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
  imaging
• 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
   Battery
   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
                   Methods
 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
  months

 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
        download

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

        Data is collected once,
        twice (or more) daily (as
        needed)
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
                                 17(42.5%)
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
      extraction

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
              time
                                  PA pressure curve




                                  PA diastolic trend




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



                            34 mmHg


Standing
                                      High Altitude


                            26 mmHg
     Decompensation and response to therapy

  Decompensation



                      Non-compliance with
                        medical therapy




Response to therapy
    (diuretics)
      Persistent high pulmonary diastolic
                   pressure



 Persistent high
      PAP




                                    Onset of AF

                   Spironolactone

No response to
 furosemide
              Pulmonary Hypertension
      Effect of Bosentan therapy and withdrawal

                                        PA Pressure 84/34 mmHg




                      Fluid overload:
 Diastolic Pressure
                         diuretics
 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




CRT
             Response to Carvedilol




Carvedilol 12.5 mg
 Detection of atrial fibrillation
 Stable
pressure




  3 days AF
    (silent)
         Possible Mode of Use

             alert




CHF Center
                     Conclusions
 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
  interventions

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

				
DOCUMENT INFO