Available Technologies for the Implantable Devices … · Available Technologies for the...

transcript

Available Technologies for the Implantable

Devices Control

Saverio Iacopino, MD, FACC, FESC

HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): Description of Techniques, Indications, Personnel, Frequency and Ethical Considerations

Europace (2008) 10, 707–725

The Incidence of Cardiovascular Implantable Electronic Devices (CIEDs) Implantation is Increasing

in 2008 throughout North America and Europe

Europace (2008) 10, 707–725

The Logistics of Monitoring these Devices Have Already Placed a Substantial and Increasing Burden on the Cardiovascular Community

>450.000 patients WW > 4000 hospitals

> 39.000 patients in Europe > 865 hospitals

> 10.000 patients in Italy >170 hospitals

The Incidence of Cardiovascular Implantable Electronic Devices

Implantation in Italy

Dati EUCOMED

Minimum Frequency of CIED Control (in Person or Remote)

Pacemakers/ICDs/CRT ü  Within 72 hours of CIED implantation (In Person) ü  2–12 weeks post implantation (In Person) ü  Every 3–12 months pacemaker/CRT-P (In Person or Remote) ü  Every 3–6 months ICD/CRT-D (In Person or Remote) ü  Every 1–3 months at signs of battery depletion (In Person or Remote)

Implantable loop recorder ü  Every 1–6 months depending on patient symptoms and indication (In Person or Remote)

Implantable hemodynamic monitor ü  Every 1–6 months depending on indication (In Person or Remote) ü  More frequent assessment as clinically indicated (In Person or Remote)

ü  Review all programmed parameters ü  Review stored events (e.g., counters, histograms,

and electrograms)

ü  If review of programmed parameters or stored events suggests a need for reprogramming or a

change in therapy, arrange a focused in-clinic

appointment

Goals of Contemporary Remote Monitoring

ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities

Circulation 2008;117;e350-e408

Europace (2008) 10, 707–725

Clinically Employed Allied Professional (CEAP): ü  The diverse group of nurses, physician assistants, technologists, technicians, and engineers who are dedicated to promoting excellence in the care of patients with CIEDs, who have cardiac rhythm or heart failure disorders ü  The CEAP works in collaboration with and/or under the direct supervision of a CIED physician and is not employed by a CIED manufacturer

Europace (2008) 10, 707–725

Indications and frequency of CIED follow-up

The ideal follow-up will be determined for the individual patient by the follow-up clinic physician(s) and CEAPs. Factors that will influence the follow-up:

ü patient preferences, ü patient’s underlying medical condition, ü CIED-related issues, ü geographic isolation from direct follow-up, ü cost-effectiveness of follow-up paradigms ü follow-up clinic resources

ü  Optimize the patient’s quality of life

ü  Optimize pacemaker/ICD system function to meet the

patient’s clinical requirements

ü  Identify patients at risk and initiate appropriate follow-up

with field safety corrective action/safety alerts

ü  Triage non–CIED-related health problems and make

appropriate referrals

Goals of follow-up: Patient related

ü  Document appropriate CIED function ü  Identify and correct abnormal CIED behavior ü  Maximize pulse generator longevity while maintaining

patient safety ü  Identify CIEDs approaching end of battery life, to

identify leads at risk of failure, and to organize CIED replacements in a non-emergent manner

Goals of follow-up: CIEDs related

ü  Document the nature and frequency of arrhythmias over time and correlate with patient symptoms and determine

the appropriateness of CIED response to these arrhythmias

ü  Document (where feasible) hemodynamic status, transthoracic impedance, patient activity and other

physiologic parameters over time as part of chronic disease monitoring in heart failure

ü  Monitor response to therapy

Goals of follow-up: Disease related

GIAC, Volume 12, Giugno 2009

ü  Il controllo remoto è un atto medico ü  Il paziente è pro-attivo:

ü  compliante alle linee-guida che ha firmato

ü  compliante alle indicazioni del medico

Percentages of Patients with Events Transmitted to the HM Service Center in 4,631 Pacemaker Recipients

Lazarus A., PACE 2007; 30:S2–S12

Single Chamber

Dual Chamber

Percentages of Patients with Events Transmitted to the HM Service Center in 3,509 ICDs Recipients

Percentages of Patients with Events Transmitted to the HM Service Center in 445 CRT-D Recipients

HM Events Occurrence and Events in Details

Nielsen JC et al., EUROPACE 2008

Patient and Physician Satisfaction with the Use of the System

Raatikainen MJ et al., EUROPACE 2008

Economic Impact of Remote Monitoring A routine ICD follow-up, including clinical and device evaluation by a cardiologist, at Oulu University Hospital costs 210 Euros

ü  Remote follow-up for ICD-therapy in patients meeting MADIT II criteria (REFORM) initiated in January 2004:

ü  The number of visits was reduced by 63.2%, where a 3.9% increase in visits through HM-induced effects ü  no significant difference in patients’ hospitalization and mortality was seen between the two arms

ü  Influence of home monitoring on the clinical status of heart failure patients (IN-TIME) started in July 2007

Several ongoing studies

Elsener C et al., Comput Cardiol 2006

Piorkowski C et al., Circulation 2006

http://www.clinicaltrials.gov/ct2/show/NCT00538356

American Heart Association. Heart Disease and Stroke Statistics - 2005 Update.

Hospital Discharges for HF

ü  Management of HF consumes 1% to 2% of healthcare budget in developed countries Berry C et al. EJHF 2001;3:283-291

ü  Hospital admissions are long (average duration of 11 days). In-hospital mortality was reported as 6.9 Cleland JG et al. EHJ 2003;24:442-463

ü  Recent efforts to reduce the risk of re-hospitalisation have focused on disease management working with patients to ensure adherence to medication and early detection of signs of decompensation Gwadry-Sridhar FH et al. Arch Int Med 2004;164:315-320

Intrathoracic Impedance Measurements

The impedance is measured between the coil of the RV lead and the can of the CRT devices or ICD

OptiVolTM Fluid Status Monitoring

Operation of Algorithm for Detecting Decreases in Impedance Over Time

Cheuk-Man Yu et al. Circulation 2005;112:841-848

OptiVol Fluid Index

Decompensated HF Compensated HF

Maximum OptiVol Fluid Index in Patients (n=106) with OptiVol Alerts with and without

Signs of Decompensated HF p < 0.05

Iacopino S. et al., Current News in Cardiology Proceedings of the Mediterranean Cardiology Meeting (Taormina, May 20–22, 2007)

Implantable CRT Device Diagnostics Identify Patients

with Increased Risk for Heart Failure Hospitalization.

ICD Diagnostics quantify HF Hospitalization Risk

Giovanni B. Perego, MD; Maurizio Landolina, MD; Giuseppe Vergara, MD; Maurizio

Lunati, MD; Gabriele Zanotto, MD; Alessia Pappone, MD; Gabriele Lonardi, MD;

Giancarlo Speca, MD; Saverio Iacopino, MD; Annamaria Varbaro, MS; Shantanu Sarkar,

PhD; Doug A. Hettrick, PhD; Alessandra Denaro, MS;

on behalf of the physicians of the Optivol-CRT Clinical Service Observational Group.

To determine the association between device-determined diagnostic indices, including intrathoracic impedance, and

heart failure (HF) hospitalization

Journal of Interventional Cardiac Electrophysiology 2008

558 HF patients indicated for CRT-D were prospectively collected from 34 centers.

Device-recorded intrathoracic impedance fluid index threshold crossing event (TCE), mean activity counts, tachyarrhythmia events, night heart rate (NHR) and heart rate variability (HRV) were compared within patients with vs. without documented HF hospitalization.

Univariate and Multivariate Predictors of HF hospitalization

Usefulness of CARELINK Network in Patients with ICD

Personal Experience XIII International Symposium on Progress in Clinical Pacing – Rome 2008

Continual Monitoring for CAREALERT Status

50 patients (36 male patients, average age 57.1 ± 19.3 years old) who underwent an ICD implantation, 42 (84%) with CRT

Percentages of Patients with Clinical Events Trasmitted

XIII International Symposium on Progress in Clinical Pacing – Rome 2008

During the first six-month monitoring 64 transmissions were carried out successfully

Notification of Atrial Arrhythmia Burden

Notification of Ventricular Arrhythmia Burden

Notification of Percentage of VP

Notification of Appropriate Therapies

ATP Therapy

Notification of Appropriate Therapies

Ventricular Fibrillation

Notification of Inappropriate Therapies

Inappropriate Therapies (RV Lead Fracture)

ATP Therapy

ICD Therapy

VT termination during RF

RF Ablation day

Follow-up

Ott 2007 Dic 2007 Feb 2008 Apr 2008 Giu 2008 Ago 2008 Ott 2008

LATITUDE® Boston Scientific

Web Server

Health Following Physician & RN

Objectives •  Device Battery Management •  Patient’s Weight Management •  Compliance with Guidelines

Device Managing Physician & RN

Objectives •  Device management •  Arrhythmia management

BSC CRM Device

Patient’s Home

LATITUDE® Weight Scale

LATITUDE® BP Monitor

LATITUDE® Communicator

Physician Benefits of Remote Monitoring

Early identification of …

Atrial Fibrillation Case study for recurrent atrial flutter

Ventricular Tachycardia Case study for shock therapy

Heart Failure Progression Case study for weight fluctuation

Loss of CRT Therapy Case study for lead impedance change

Clinical action taken … –  Anticoagulation –  Cardioversion –  Ablation

–  Device reprogramming –  Ablation

–  Office visit –  Medication

–  Electronic Repositioning™

ü Appropriate follow-up monitoring of patients with CIEDs is critical to the achievement of maximal clinical benefit from their implantation and is essential for the prevention and management of potential adverse outcomes related to the device

Conclusions

ü The monitoring should be done by professionals who are specially trained and dedicated to this special patient population ü With the increasing complexity of devices and the widening array of technologies involved in monitoring, the device industry, health care institutions and physician practices must provide the necessary infrastructure and personnel in order for this care to be effective and safe

Conclusions

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