|Year : 2022 | Volume
| Issue : 3 | Page : 147-151
Safety and efficacy profile of an indigenous developed CHARAK DDDR 747R dual-chamber rate-responsive pacemaker: A prospective study from a tertiary care center in North India
Yash Paul Sharma1, Akash Batta2, Saurabh Mehrotra1, Prashant Panda1, Surendra Sethi3
1 Department of Cardiology, Advanced Cardiac Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India
2 Department of Cardiology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India
3 Department of Cardiology, Butler Memorial Hospital, Butler, PA, USA
|Date of Submission||16-Aug-2022|
|Date of Decision||01-Oct-2022|
|Date of Acceptance||21-Nov-2022|
|Date of Web Publication||14-Dec-2022|
Department of Cardiology, Advanced Cardiac Centre, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh - 160 012
Source of Support: None, Conflict of Interest: None
Aim: The purpose of this study was to assess the safety and performance of the domestically manufactured Charak DDDR 747R (Pacetronix Ltd, Indore, India) pacemaker device.
Materials and Methods: This was a prospective, controlled, single-center study conducted between March 2016 and August 2017. Eligible patients were implanted with a Charak DDDR 747R pacemaker with parameters set as specified on the packaging material unless otherwise advised by the physician. Patients were evaluated before discharge and at the 18-month follow-up. Data such as patient age, gender, and medical history were collected to determine patient eligibility for study participation, monitoring of study progress, and data analysis.
Results: A total of 35 patients were analyzed. Males comprised 45.7% and females comprised 54.3% of patients. The average pacing threshold was threshold (atrium) was 1.05 V and the average pacing threshold (ventricle) was 1.07 V. The average impedance (atrium) was 641.09 Ω and the average impedance (ventricle) was 719.31 Ω. No serious adverse events were documented during the follow-up. One death occurred; however, this was not device-related.
Conclusions: As per study findings, the Charak DDDR 747R, an indigenous pacemaker, is safe and effective in the Indian population. Durable lead parameters were obtained during the study which remained stable over time referring the same. Future larger studies are needed to confirm the preliminary data obtained from our study.
Keywords: Charak DDDR 747R, dual-chamber rate-responsive pacemaker, Pacetronix, permanent pacemaker implantation
|How to cite this article:|
Sharma YP, Batta A, Mehrotra S, Panda P, Sethi S. Safety and efficacy profile of an indigenous developed CHARAK DDDR 747R dual-chamber rate-responsive pacemaker: A prospective study from a tertiary care center in North India. Heart India 2022;10:147-51
|How to cite this URL:|
Sharma YP, Batta A, Mehrotra S, Panda P, Sethi S. Safety and efficacy profile of an indigenous developed CHARAK DDDR 747R dual-chamber rate-responsive pacemaker: A prospective study from a tertiary care center in North India. Heart India [serial online] 2022 [cited 2023 Feb 3];10:147-51. Available from: https://www.heartindia.net/text.asp?2022/10/3/147/363540
| Introduction|| |
Atrioventricular (AV) heart block refers to an interruption or delay in electrical conduction from the atria to the ventricles. This occurs when the atrial impulse is either delayed or not conducted to the ventricles. The block may occur at the AV node, a bundle of HIS, or the bundle branches. There are three types of blocks described according to severity. The first-degree AV blocks are characteristic of a prolonged P-R interval >200 ms without a greater degree of blocks. The second-degree blocks are of Mobitz type I or type II. Type I is characteristic of gradual prolonged P-R interval succeeding beats, leading to a nonconducted P wave, whereas Mobitz type II occurs when the P-R intervals for conducted P waves are the same before and after a nonconducted P wave. The third-degree blocks or complete heart block is characteristic of independent atrial and ventricular beats due to a loss of conduction from the former to the latter. Permanent pacemakers are implanted to overcome electrical disturbances such as AV blocks. Against this background, the current study sought to assess the safety and performance of the domestically manufactured Charak DDDR 747R (Pacetronix Ltd, Indore, India) pacemaker device.
| Materials and Methods|| |
Study design and patient population
This was a prospective, single-center, observational study conducted between March 2016 and August 2017. All patients who underwent permanent pacemaker implantation with a Charak DDDR 747R (Pacetronix Ltd, Indore, India) during this time were enrolled and followed up. The pacemaker was set in DDD mode at the time of packaging and the rate response mode was turned off. Thus, pacemakers were in DDD mode at the time of implantation. The inclusion criteria were: (i) fixed (third degree) AV block, (ii) atrial fibrillation with an average ventricular rate on electrocardiography ≤40 bpm or mean heart rate ≤60 bpm, (iii) sinus node dysfunction with or without associated AV conduction disorder, (iv) paroxysmal persistent or permanent atrial fibrillation undergoing AV node, AV node/HIS ablation, (v) second-degree AV block ≥3:1 block, and (vi) patient age 18 years or older. The exclusion criteria were: (i) preexisting permanent cardiac pacemaker or implantable cardioverter defibrillator, (ii) presence of hypertrophic obstructive cardiomyopathy, (iii) recent cardiac surgery (≤30 days), (iv) recent myocardial infarction (≤30 days), (v) presence of mechanical prosthetic tricuspid valve, (vi) current or planned pregnancy in the next 1 year, (vii) life expectancy <1 year, or (viii) chronic renal failure. The study protocol was approved by the institutional ethics committee before the study commencement. All patients provided written informed consent for study participation.
The Charak DDDR 747R (Pacetronix Ltd, Indore, India) is a dual-chamber responsive implantable pacemaker that has two systemic components. The first component is the implantable component that contains the pacemaker device with either bipolar ventricular lead or screw-in and atrial J-shaped bipolar lead. The second component is the monitoring system that contains programming interface, programming head, and software. The pacing modes include DDD, VDD, DDI, DVI, DOO, VVI, AAI, AAT, AOO, DDDR, VDDR, DDIR, DVIR, DOOR, VVIR, VOOR, VVTR, AAIR, AOOR, AATR, OAO, OVO, ODO, and OFF. Basic rates are 30–120 bpm in steps of 2 bpm. The upper tracking rate (sensor rate) is 80–180 bpm in steps of 2 bpm. The upper triggering rate is 80–180 bpm in steps of 2 bpm. The battery is lithium iodine. The initial voltage is 2.8V. The expected life of the device if paced at 100% at 70 min−1 in DDD mode with 2.5 V amplitude (A and V) with a pulse width of 0.5 ms and lead impedance of 500 Ω is 10 years. The Charak DDDR 747R is shown in [Figure 1].
|Figure 1: The Charak DDDR 747R dual-chamber responsive implantable pacemaker|
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Follow-up and data collection
Patients were evaluated before discharge and assessed at 1-month follow-up unless there were complaints of any complications or discomfort during this 1 month. At the 1-month follow-up, the proper functioning of the device and the patient's condition were assessed. Pacing threshold and lead impedance were also assessed to capture data. At the second follow-up, i.e., the 2-month follow-up, patients were randomly selected to add additional device features to assess the functional performance of the device. Using the programming interface, some patients were put on rate-response mode, and some were put on AV hysteresis mode at this 2-month follow-up visit. The randomization process was selected at the 2-month follow-up to allow for the stabilization of the device. This also assisted in evaluating and assessing the possible complication rate in the first 60 days. The duration of the patient participation in this study was 18 months and patients came for a total of 6 follow-ups during the study duration. Data such as patient age, gender, and medical history were collected to determine patient eligibility for study participation, monitoring of study progress, and data analysis.
Adverse and serious adverse events
Several adverse events may occur during and postpacemaker implantation. These include erosion through the skin, hematoma, infection, local tissue reaction, pacemaker-mediated tachycardia due to retrograde conduction, pulse generator migration, transvenous lead-related thrombosis, body rejection phenomena, and muscle and nerve stimulation. In addition, electronic devices such as pulse generators are subjected to random component battery failures that cannot be predicted and may lead to failure to pace. Lead-related complications include cardiac tamponade, lead fracture displacement, and cardiac perforation. Elevated thresholds and fibrotic tissue formation also may cause a pacing system to cease functioning with unipolar leads possible. Side effects include myopotential sensing and pectoral muscle stimulation.
The intensity of adverse and serious adverse events was classified as mild, moderate, or severe. A mild event was defined as an event that could be tolerated by the patient with minimal discomfort. A moderate event was defined as an event that caused discomfort and interfered with normal activities. A severe event was defined as an event that prohibits patients from performing routine activities.
| Results|| |
A total of 35 patients were included in this study. All patients completed the follow-ups. The mean patient age was 61.8 years. Males comprised 16 (45.7%) patients and females comprised 19 (54.3%) patients of the study population. The average pacing threshold (atrium) was 1.05 V and the average pacing threshold (ventricle) was 1.07 V. The average impedance (atrium) was 641.09 Ω and the average impedance (ventricle) was 719.31 Ω as shown in [Figure 2] and [Figure 3].
An appropriate increase of rate during activity and an appropriate rate decrease following cessation of activity in DDDR pacing mode was noted. There were no events of unexpected sensor behavior during any activity or sensor parameter optimizations. The treadmill test report of few patients also displayed a successive increase in rate with activity. No abnormal increase or decrease in rate was observed during exercise. The change in rate was with respect to slope and up/downtime. No device-related complications were observed during the follow-up evaluations. Few events were immediately resolved by the study investigator through the programming of pulse generator, for example, adjustment of rate-responsive parameters to accommodate the change in pacemaker rate as per activity and change in amplitude in case of a small increase of threshold. Interaction of the programming system (SMART E Interface and Programming head) and system programming language software with the Charak DDDR 747R including interrogation, programming, and use of other features were reliable. The diagnostic feature of the software was very useful to detect the current status of implant lead and pacemaker.
| Discussion|| |
Contemporary pacemakers afford an increased number of programmable parameters and specific algorithms designed to optimize pacing therapy with respect to the individual characteristics of the patient. However, the type of arrhythmia at the time of pacemaker implantation time, cardiac chamber that requires pacing, percentage pacing necessary to eliminate rhythm disorders, possible association of multiple rhythm disturbances and conduction diseases, and the development of conduction disorder during follow-up are critical aspects to be taken into account.
A recent study investigated the lifespan and expectancy of patients undergoing double-chamber (DDD) pacemaker implantation due to bradycardia for 15 years. The study revealed (i) an increase in mean implantation age from 70 years in 1999 to 75.7 years in 2015, (ii) the number of years post-DDD pacemaker implantation increased from 2.6 years to 8.2 years, and (iii) the mean age at death increased from 72.6 years to 83.8 years. Moreover, the years of life lost per death decreased from 17.4 years to 9 years. All these findings were statistically significant, thus supporting the conclusion of improvement in life expectancy in patients implanted with a DDDR pacemaker. In the MOST trial 2010, patients with sinus node disease were randomized to DDD (n = 1,014) and VVI (n = 996). The study revealed that dual-chamber pacing reduced the risk of atrial fibrillation and heart failure, and slight improvement in quality of life. A subanalysis of this trial further revealed the development of severe pacemaker syndrome in 20% of VVIR-paced patients, which resolved on reprogramming to DDDR mode. Another three studies compared DDD and DDDR pacing in sinus node dysfunction patients revealed DDR pacing improved quality of life and exercise capacity.,,
Charak DDDR 747R is a domestically manufactured dual-chamber rate-responsive pacemaker which could reduce the cost burden of imported pacemakers for the many patients suffering from arrhythmia. The present study demonstrates the safety and efficacy of the Charak DDDR 747R. The average pacing threshold (atrium) was 1.05 V and the average pacing threshold (ventricle) was 1.07 V. The average impedance (atrium) was 641.09 Ω and the average impedance (ventricle) was 719.31 Ω. Similar to the present study, another study also assessed the safety and efficacy of an indigenously manufactured DR implantable cardiac pacemaker and compared with Talos DR (Biotronik, Berlin, Germany), a commercially available DR implantable cardiac pacemaker. The study documented RA pacing threshold of 0.63 ± 0.28 V for the indigenously manufactured DR implantable cardiac pacemaker and 0.65 ± 0.27 V for the Talos DR (Biotronik, Berlin, Germany). Similarly, the RV pacing threshold was 0.67 ± 0.27 V vs. 0.58 ± 0.22 V, respectively.
The study adds to the body of evidence supporting indigenous devices in our health-care setting. It offers an affordable and reliable solution to the management of patients with advanced heart block, and sinus node dysfunction of those needing pacemakers for other reasons. A comparison of the relative costs of dual-chamber rate-responsive pacemakers by different vendors has been shown in [Table 1]. On average, the price of pacemakers by various vendors is 1.5–2 times higher than the indigenous Charak DDDR 747R. It reduces the dependence on foreign pacemakers which are expensive and may not be readily available in all settings. The COVID-19 pandemic has strained the already thin health-care system in our country and has made a strong case for the need for improving and revamping our health-care system. The coming up of this indigenous pacemaker will help to decrease the dependence on imported pacemakers in our country and provide affordable care to those in need.
|Table 1: Approximate cost in Indian national rupees of dual-chamber rate responsive pacemakers by different vendors in comparison to the Indigenous Charak DDDR 747R by Pacetronix|
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A major limitation of the study is the small number of patients in our study and the lack of a comparative arm. Hence, the safety and efficacy seen in our study need to be confirmed in other settings involving a larger number of patients. However, the index study serves as a feasibility study and the preliminary data as shown in our study is promising.
| Conclusions|| |
No serious adverse events were documented during the follow-up. One death occurred; however, this was not device-related. Thus, as per study findings, the Charak DDDR 747R is safe and effective. To the best of our knowledge, this is the only study on this device available to date. This is can go a long way in providing affordable care to these subsets of patients.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
The study protocol conforms to the ethical guidelines of the Declaration of Helsinki and written informed consent was obtained from all participants of this study.
Data collection: YPS, PP
Patient management: PP
Manuscript writing: YPS, AB, PP
Manuscript reviewing: YPS, PP, SM, SS
Manuscript approval: YPS, PP, SS.
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[Figure 1], [Figure 2], [Figure 3]