**3. Advantages and challenges of telecardiology**

#### **3.1. Physicians**

**Figure 2.** Some manufacturers use RF to interrogate and program remotely on a short distance. This is of particular

The ability of implantable devices to continuously monitor variables such as heart rate, [9,10] the patient's daily activities, [11] intrathoracic impedance for the detection of fluid ac‐ cumulation, [12] the occurrence of arrhythmias [13,14] and the integrity of the system [15] may provide early warning of changes in cardiac status or of safety issues and allow timely management. When these patients have clinical events such as ICD shocks or device audible alert notifications of possible critical situations, they often visit the emergency department

ICD and lead dysfunction may be associated with severe consequences and could be antici‐ pated thanks to home monitoring alerts. Patients could be contacted to correct the problem

Significant change in lead impedance, pacing or sensing thresholds, could be linked to lead failure and should be investigated thoroughly. It has been reported that remote monitoring

in office for reprogramming or in hospital if a procedure is needed. [16-17]

helps prevent inappropriate shocks in a population at risk. [18]

interest during in person follow up (a) and during implantation procedure (b)

or clinic for an unscheduled examination.

**2.3. Types of alerts**

96 Cardiac Defibrillation

Because of the burden of follow-up of ICD patients, with regular in-office visits every 3-6 months, puts on specialized electrophysiology clinics Heidbuchel et al. [19] retrospectively evaluated in 1739 ICD visits in a random set of 169 patients. The standard follow-up scheme consisted of in office visits 1 month after implantation and then every 6 months, unless ap‐ proaching battery depletion. They conclude that ICD remote monitoring can potentially di‐ agnose 99.5% of arrhythmia or device-related problems if combined with a follow-up by the local general practitioner and/or referring cardiologist. Its use may provide a way to signifi‐ cantly reduce in-office follow-up visits that are a burden for both hospitals and patients. A similar study was performed by Elsner et al. [20]. They investigated in a prospective, randomized, and multicentre comparison study the effect of ICD home monitoring against conventional follow-up in 115 MADIT II patients. The results prove that the simplified ICD follow-up scheme with additional home monitoring in MADIT II patients can reduce the number of visits and lead to time reduction.

In 2011 Boriani et al. published a survey [21] indicating that in 'real-world' clinical practice, the follow-up of CIEDs requires important resources in terms of time dedicated by special‐ ized personnel, corresponding to cardiologists, nurses, internal technicians, and also, exter‐ nal, industry-employed technicians.

malfunctions of the ICD lead compared the rate of symptomatic lead failure in patients monitored remotely with those followed up in-clinic [31]. Inappropriate shocks occurred in 27.3% of the remote group compared with 46.5% of the in-clinic group. This trend gains stat‐ istical significance if the compound endpoint of inappropriate shocks and symptomatic pac‐ ing inhibition due to oversensing is focused; 27.3% in the remote group compared with 53.4% in the in-clinic group. The remote monitoring system sent alert messages in 91% of all

ICD in the Era of Telecardiology http://dx.doi.org/10.5772/53361 99

Mabo reported in the EVATEL study [32], a randomized trial that included 1500 patients im‐ planted with single or dual chamber ICD that "Home monitoring leads to a decrease of 37%

Kacet reported similar results in the ECOST study [33]: "home monitoring reduces by 76% the number of aborted ICD charges with a significant impact on battery status and device

Raatikainen et al. [34] reported that over 90% of patients found the system easy to use. Mar‐ zegalli et al. [35] also reported that the review procedure was successful. Its mean duration was 5 ±2 minutes per transmission and users indicated that both access and navigation were easy. Patients reported a general preference for remote versus in clinic follow-up and descri‐ bed a sense of reassurance created by the remote monitoring capacity. In a study of 379 pa‐ tients implanted with pacemakers, Halimi et al. reported all differences in the SF-36 questionnaire scores to be non-statistically significant [36]. Patient satisfaction was studied recently by Petersen et al. [23]: of the 385 of the patients that answered the survey (81.2%), ninety-five percent were content with the remote Follow up. Only 25% had unscheduled transmissions and most unscheduled transmissions were for appropriate reasons. Eightyfour percent of the patients wished for a more detailed response and 21% wished for a faster

Current ICDs provide not only arrhythmia information but also several indicators of heart failure (HF). Studies are under way to evaluate the benefits of HF specifics diagnostics cou‐

While remote monitoring (RM) may be able to reduce the time spent on device follow up it is not clear whether this relates to an overall reduction in costs. RM has its own costs includ‐ ing the cost of the transmitter, the setup and maintenance of the central server and database, patient and clinic staff education and staff time to read, interpret, import information into electronic medical records and act on transmission events/problems. The frequency of in of‐ fice visits and the frequency of RM transmissions, proximity of the patient to the clinic and many other factors will affect the economic modeling as to the potential cost savings associ‐ ated with RM. Beyond assessing the simple economic modeling is the assessment of cost ef‐ fectiveness which also needs to consider the improvement in patient outcomes as well as the

incidents, enabling intervention to prevent aninappropriate shock.

of inappropriate shocks.

reply after routine transmissions.

pled with home monitoring [25, 26].

costs involved for each form of follow up.

**3.3. Health economics**

longevity".

More recently Cronin et al. [22] found that analysis of remote monitoring transmissions has significant implications for device clinic workflow. Non-actionable transmissions are rapidly processed, allowing clinicians to focus on clinically important findings.

According to Theuns et al. [24]: "remote monitoring is feasible, may facilitate ICD follow up, and lead to early detection of system-related complications. Continuous monitoring of spe‐ cific device parameters may avoid unnecessary replacements of devices or leads. However, as with every new technology, there are areas of uncertainty. Remote monitoring is associat‐ ed with a redesigned organization of the care system, including physicians, allied professio‐ nals, and a dedicated remote monitoring service. Another area of uncertainty is related to the question of liability. The now "virtual patient" poses a paradigm shift. Physicians have the responsibility for responding to the new sources of data. How fast must a physician re‐ act to the transmitted alerts? Do we need 24 hours, 7 days a week coverage or is it legally acceptable not to check event notifications outside the office hours ? The development of practice guidelines on the appropriate role of remote monitoring of patients with implanted cardiac devices would help to address many of these issues."

#### **3.2. Patients**

Besides the decrease in number of in office follow up, safety and more rapid detection of actionable events compared with conventional monitoring in patients with implantable elec‐ tronic cardiac devices were demonstrated in several studies:

In Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) multicentre trial [27, 28] authors concluded that home monitoring detected more device related issues and earlier compared with those following calendar-based or symptom-driven in-person interroga‐ tions. The results confirmed that conventional in-person follow-up methods underreport de‐ vice malfunctions.

In the AWARE Study [29], Lazarus et al. analysed transmissions of 11624 recipients: 4631 pacemakers, 6548 single or dual chamber defibrillators and 445 cardiac resynchronisation therapy defibrillators (CRT-D) systems. The mean interval between the last follow-up and the occurrence of events notified by home monitoring was 26 days, representing a putative temporal gain of 154 and 64 days in patients usually followed up at 6 and 3 month intervals, respectively.

In 2010, the ALTITUDE registry showed that for the 69556 ICD and CRT-D patients receiv‐ ing remote follow-up on the network, 1 and 5 year survival rates were higher compared with those in the 116 222 patients who received device follow-up in device clinics only (50% reduction; *p*=0.0001) [30].

Another example of remote monitoring improving clinical outcomes is its potential to re‐ duce symptomatic lead failures, consisting of inappropriate shocks and symptomatic pacing inhibition due to oversensing. A study of patients who underwent repeat surgery due to malfunctions of the ICD lead compared the rate of symptomatic lead failure in patients monitored remotely with those followed up in-clinic [31]. Inappropriate shocks occurred in 27.3% of the remote group compared with 46.5% of the in-clinic group. This trend gains stat‐ istical significance if the compound endpoint of inappropriate shocks and symptomatic pac‐ ing inhibition due to oversensing is focused; 27.3% in the remote group compared with 53.4% in the in-clinic group. The remote monitoring system sent alert messages in 91% of all incidents, enabling intervention to prevent aninappropriate shock.

Mabo reported in the EVATEL study [32], a randomized trial that included 1500 patients im‐ planted with single or dual chamber ICD that "Home monitoring leads to a decrease of 37% of inappropriate shocks.

Kacet reported similar results in the ECOST study [33]: "home monitoring reduces by 76% the number of aborted ICD charges with a significant impact on battery status and device longevity".

Raatikainen et al. [34] reported that over 90% of patients found the system easy to use. Mar‐ zegalli et al. [35] also reported that the review procedure was successful. Its mean duration was 5 ±2 minutes per transmission and users indicated that both access and navigation were easy. Patients reported a general preference for remote versus in clinic follow-up and descri‐ bed a sense of reassurance created by the remote monitoring capacity. In a study of 379 pa‐ tients implanted with pacemakers, Halimi et al. reported all differences in the SF-36 questionnaire scores to be non-statistically significant [36]. Patient satisfaction was studied recently by Petersen et al. [23]: of the 385 of the patients that answered the survey (81.2%), ninety-five percent were content with the remote Follow up. Only 25% had unscheduled transmissions and most unscheduled transmissions were for appropriate reasons. Eightyfour percent of the patients wished for a more detailed response and 21% wished for a faster reply after routine transmissions.

Current ICDs provide not only arrhythmia information but also several indicators of heart failure (HF). Studies are under way to evaluate the benefits of HF specifics diagnostics cou‐ pled with home monitoring [25, 26].

#### **3.3. Health economics**

ized personnel, corresponding to cardiologists, nurses, internal technicians, and also, exter‐

More recently Cronin et al. [22] found that analysis of remote monitoring transmissions has significant implications for device clinic workflow. Non-actionable transmissions are rapidly

According to Theuns et al. [24]: "remote monitoring is feasible, may facilitate ICD follow up, and lead to early detection of system-related complications. Continuous monitoring of spe‐ cific device parameters may avoid unnecessary replacements of devices or leads. However, as with every new technology, there are areas of uncertainty. Remote monitoring is associat‐ ed with a redesigned organization of the care system, including physicians, allied professio‐ nals, and a dedicated remote monitoring service. Another area of uncertainty is related to the question of liability. The now "virtual patient" poses a paradigm shift. Physicians have the responsibility for responding to the new sources of data. How fast must a physician re‐ act to the transmitted alerts? Do we need 24 hours, 7 days a week coverage or is it legally acceptable not to check event notifications outside the office hours ? The development of practice guidelines on the appropriate role of remote monitoring of patients with implanted

Besides the decrease in number of in office follow up, safety and more rapid detection of actionable events compared with conventional monitoring in patients with implantable elec‐

In Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) multicentre trial [27, 28] authors concluded that home monitoring detected more device related issues and earlier compared with those following calendar-based or symptom-driven in-person interroga‐ tions. The results confirmed that conventional in-person follow-up methods underreport de‐

In the AWARE Study [29], Lazarus et al. analysed transmissions of 11624 recipients: 4631 pacemakers, 6548 single or dual chamber defibrillators and 445 cardiac resynchronisation therapy defibrillators (CRT-D) systems. The mean interval between the last follow-up and the occurrence of events notified by home monitoring was 26 days, representing a putative temporal gain of 154 and 64 days in patients usually followed up at 6 and 3 month intervals,

In 2010, the ALTITUDE registry showed that for the 69556 ICD and CRT-D patients receiv‐ ing remote follow-up on the network, 1 and 5 year survival rates were higher compared with those in the 116 222 patients who received device follow-up in device clinics only (50%

Another example of remote monitoring improving clinical outcomes is its potential to re‐ duce symptomatic lead failures, consisting of inappropriate shocks and symptomatic pacing inhibition due to oversensing. A study of patients who underwent repeat surgery due to

processed, allowing clinicians to focus on clinically important findings.

cardiac devices would help to address many of these issues."

tronic cardiac devices were demonstrated in several studies:

nal, industry-employed technicians.

**3.2. Patients**

98 Cardiac Defibrillation

vice malfunctions.

respectively.

reduction; *p*=0.0001) [30].

While remote monitoring (RM) may be able to reduce the time spent on device follow up it is not clear whether this relates to an overall reduction in costs. RM has its own costs includ‐ ing the cost of the transmitter, the setup and maintenance of the central server and database, patient and clinic staff education and staff time to read, interpret, import information into electronic medical records and act on transmission events/problems. The frequency of in of‐ fice visits and the frequency of RM transmissions, proximity of the patient to the clinic and many other factors will affect the economic modeling as to the potential cost savings associ‐ ated with RM. Beyond assessing the simple economic modeling is the assessment of cost ef‐ fectiveness which also needs to consider the improvement in patient outcomes as well as the costs involved for each form of follow up.

#### **3.4. Limits of telecardiology**

A network failure may delay transfer of data. Most of telecardiology departments do not have 24/7services. Thus, an alert message issued on a Friday night has a good chance not to be examined before the following Monday. In addition transferred data through the net‐ work are privileged, leading to legal considerations regarding reliability of the technology and confidentiality especially during emergency situations. To add another level of com‐ plexity, each country seems to have a different modus operandi at this point in time.

deavor. It concludes that "remote monitoring can reduce emergency department/urgent in office visits and, in general, total healthcare use in heart failure patients with modern ICD/ CRT-D. Compared with standard follow-up through in-office visits and audible ICD alerts, re‐ mote monitoring results in increased efficiency for healthcare providers and improved quality of care for patients". Another study is under way to develop a cost minimization analysis from the hospital perspective and a cost effectiveness analysis from the third payer standpoint, based on direct estimates of costs and QOL associated with remote follow-ups, compared with

ICD in the Era of Telecardiology http://dx.doi.org/10.5772/53361 101

standard ambulatory follow-ups, in the management of ICD and CRT-D recipients [38].

Remote monitoring of ICDs represents a growing area with increasing numbers of patients being subject to these technologies but also more and more physicians involved in decision making on the indications for these technologies and the handling of data in the context of

Cardiac implantable device transmissions may occur either over telephone lines or over cel‐ lular network lines. These transmissions often only take less than a minute to a few minutes to complete. However, in the foreseeable future we can expect alternative methods of data transmission to become available with transmission rates that will make it possible for near‐ ly continuous and instantaneous patient ICD data delivered to health care providers. There are, of course, limitations to how frequently ICD data can be reviewed by health care pro‐ viders and battery longevity constraints will likely limit the transmission times as well.

Technological advancements continue to structure our practice of medicine, but with it often new legal challenges emerge. In order to minimize risk to patient and liability to health care providers a clear discussion regarding the expectations and limitations of remote monitor‐

The authors thank Muriel Bon, Michelle Hartenstein, Xavier Laroche, Ariane Szczygiel, Mar‐ ion De Matteis, Moti Daswani and Vincent Desplat for their expert technical assistance, and

J. Taieb, J. Bouet, R. Morice, J. Hourdain, B. Jouve, Y. Rahal, T. Benchaa, H. Khachab,

ing between patients and health care providers is recommended

Fabrice Chomienne, for his help in the composition of the manuscript.

**4. Conclusion**

clinical decision making.

**Acknowledgements**

**Author details**

O. Rica and C. Barnay

Hospital Center of Aix en Provence, France

Health care providers and health care organizations that are involved in remote monitoring (RM) of ICDs will typically sign a 'Terms of Use' agreement with each of the ICD vendors. These legal documents outline the provisions of RM between the ICD vendor and the user. The patient needs to be informed of the purpose and limitations of RM, such as the fact that it does not replace an emergency service or absence of dealing with alert events outside of‐ fice hours. Before initiating RM and follow-up, the patient may be requested to sign a writ‐ ten informed consent stating these points and authorizing transmission of personal data to third parties, respect of privacy, and confidentiality of patient data by device companies should be subjected to strict rules, described in contracts. Cardiac implantable devices re‐ cord a wealth of information and as devices become more sophisticated the scope of infor‐ mation can be expected to grow. Guidelines need to be established to determine the periodicity with which ICD transmissions would need to be reviewed and documented.

Vulnerability of security breaches by hackers accessing devices with wireless capability must be tested in every system. There have been no reports to date of unauthorized reprog‐ ramming of implantable devices; however, unauthorized access to personal information stored on internet servers must be also considered.

In addition, transfer of ICD data would be impossible if the home monitoring station is not close to the patient at reasonable time intervals. This could be happening in case of hospitali‐ zation in another center. The patient could even experience serious system failure without any data transmission.

Logistics may also be a limit to the development of home monitoring: It is up to the implant‐ ing center to organize ordering, stock management and traceability of home monitoring sta‐ tions as well as patient education. The Sorin group is the only one so far using a distribution network to handle all these tasks.

#### **3.5. Reimbursement**

Reimbursement is important to the manufacturer in order to compensate for some of the costs related to the home monitoring stations and the transmission network. It remains a major con‐ cern in most countries, limiting the increase of use of remote monitoring despite growing evi‐ dence in favor of this technology. Today's cost containment pressure requires increased reimbursement efforts with the burden of proof shifting to medical communities and manufac‐ turers. Reimbursement assessments often begin with the presumption that a technology or service will not be covered unless its use is supported by scientific evidence of improved out‐ comes. Recent publications like the EVOLVO study [37] are important milestones in this en‐ deavor. It concludes that "remote monitoring can reduce emergency department/urgent in office visits and, in general, total healthcare use in heart failure patients with modern ICD/ CRT-D. Compared with standard follow-up through in-office visits and audible ICD alerts, re‐ mote monitoring results in increased efficiency for healthcare providers and improved quality of care for patients". Another study is under way to develop a cost minimization analysis from the hospital perspective and a cost effectiveness analysis from the third payer standpoint, based on direct estimates of costs and QOL associated with remote follow-ups, compared with standard ambulatory follow-ups, in the management of ICD and CRT-D recipients [38].
