Clinical profile, complications, and quality of life in patients undergoing automatic implantable cardioverter-defibrillator implantation in a tertiary care hospital of North India

Suraj Khanal; Piyush Pathak; Ajay Bahl

doi:10.4103/JCPC.JCPC_17_19

ORIGINAL ARTICLE

Year : 2019 | Volume : 8 | Issue : 3 | Page : 131-135

Clinical profile, complications, and quality of life in patients undergoing automatic implantable cardioverter-defibrillator implantation in a tertiary care hospital of North India

Suraj Khanal MBBS, MD, DM ¹, Piyush Pathak MBBS, MD ², Ajay Bahl MBBS, DRM, DM ¹
¹ Department of Cardiology, Advanced Cardiac Centre, Chandigarh, India
² Department of Medicine, PGIMER, Chandigarh, India

Date of Web Publication

31-Jul-2019

Correspondence Address:
Dr. Suraj Khanal
Department of Cardiology, 3^rd Floor, Block-C, Advanced Cardiac Centre PGIMER, Chandigarh - 160 012
India

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/JCPC.JCPC_17_19

Abstract

Background: Despite better understanding of various aspects of Sudden Cardiac Death (SCD), mortality from the disease still remains very high. Coronary artery disease (CAD) is the most common cause of SCD in all parts of India. The American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society (ACC/AHA/HRS) guidelines recommend the use of implantable cardioverter-defibrillator (ICD) therapy as a primary prevention. Aim: The aim of our study was to assess the clinical and demographic profile, complications and quality of life (QOL) of patients undergoing ICD implantation as compared to controls at a tertiary care center of north India. Method: A total of 64 patients with mean age 54.39± 11.54 years were implanted ICD during a period of one year. During the same period, 51 patients in which ICD could not be implanted due to financial reasons were included as controls. Of the 64 patients, 43 (67.19%) patients received ICD for primary prevention whereas 21 (32.81%) patients received it for secondary prevention. Result: At a follow up of 6 months, mortality was 4 (7.84%) in ICD group as compared to 8 (15.69%) in control group. Mortality from SCD in ICD and control group was 2 and 5 respectively (P = 0.23). ICD interrogation data was collected for 37 cases of which 19 (51.35%) patients had records of ventricular tachycardia (VT) and 3 (8.1%) patients had records of ventricular fibrillation (VF) respectively. Total VT/VF episodes recorded in primary prevention group were 10, whereas 12 in secondary prevention group. Success rate of ATP and ICD shocks were 30.23% and 95.92% respectively. All 47 VT/VF episodes were terminated by shocks. Conclusion: The QOL of patients undergoing ICD implant was better in the domains of social relationship and environment though the difference was not significant statistically. Overall, there was a significant reduction in SCD mortality and no deterioration in QOL.

Keywords: Automatic implantable cardioverter-defibrillator, mortality, quality of life, shock, sudden cardiac death

How to cite this article:
Khanal S, Pathak P, Bahl A. Clinical profile, complications, and quality of life in patients undergoing automatic implantable cardioverter-defibrillator implantation in a tertiary care hospital of North India. J Clin Prev Cardiol 2019;8:131-5

How to cite this URL:
Khanal S, Pathak P, Bahl A. Clinical profile, complications, and quality of life in patients undergoing automatic implantable cardioverter-defibrillator implantation in a tertiary care hospital of North India. J Clin Prev Cardiol [serial online] 2019 [cited 2023 Jun 9];8:131-5. Available from: https://www.jcpconline.org/text.asp?2019/8/3/131/263829

Introduction

Despite remarkable advancements in the diagnosis and treatment of cardiovascular disease (CVD), sudden cardiac death (SCD) still remains a major public health concern globally accounting for approximately one half or more of all cardiac deaths.^[1],[2]

The epidemiological transition in low-income countries including India has made lifestyle diseases a major public health problem. At present, 25% of all deaths in India are attributable to coronary artery disease (CAD) and stroke, causing almost 4 of 5 deaths due to CVD. Age-standardized CVD death rate is 272 per 100,000 population in India as compared to the global average of 235 per 100,000 population. This coronary and stroke epidemic in India is occurring at younger age with a higher case fatality as compared to the Western world. CVD has emerged as the leading cause of death in all parts of India, including poorer states and rural areas.^[3] A population study on 22,724 individuals from South India had shown high prevalence of major risk factors for CAD in India with 173 (10.3%; 128 M and 45 F; mean age: 60.8 ± 14 years) deaths due to SCD occurring 5–8 years earlier as compared to Western population.^[4] Rapid pace of economic development and urbanization is likely related to this rapid epidemiological transition in India. CAD is now affecting Indians with a higher percentage of acute coronary syndrome of ST-elevation myocardial infarction.^[5] Recent estimates show the prevalence of CAD to be around 7%–13% in urban and 2%–7% in rural India.^[6] The rhythm observed in victims of out-of-hospital cardiac arrest depends on the time elapsed between collapse and the first ECG recording. Ventricular fibrillation (VF) accounts for 95% of cardiac arrests if this interval is <4 min. If the time elapsed is not known, VF represents the first rhythm identified in 40% of the cases, followed by asystole in 40%, electromechanical dissociation in 20%, and ventricular tachycardia (VT) in <1% of cases. As the role of implantable cardioverter-defibrillator (ICD) in the prevention of SCD is getting established, the number of automated ICD implanted each year is on a rise.^[7] In 2009, a worldwide survey of cardiac pacing and ICD was carried out in 61 countries including 25 from Europe, 20 from Asia-Pacific region, 7 from the Middle East and Africa, and 9 from the Americas. This survey involved 328,027 ICDs comprising 222,407 as new implants and 105,620 as replacements. All countries showed an increase in the number of implants, with the USA leading the chart with 434 new implants per million population.^[8] From its initial conception for the secondary SCD prevention in selected patients with documented ventricular tachyarrhythmias, ICD technology has advanced including S-ICD and various dual chamber ICDs with remote monitoring features.^[9],[10] The current clinical guidelines recommend ICD utilization in patients with symptomatic heart failure (New York Heart Association [NYHA] Class II–III) and in cases of reduced left ventricular ejection fraction for the primary prevention of SCD.^[1] The American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines also recommend ICD therapy as a primary prevention.^[11],[12] Therefore, in the present study, we aimed to evaluate the clinical and demographic profile of patients undergoing ICD implantation as compared to controls at a tertiary care center of North India. The other objectives were to describe various indications for the ICD implantation (ischemic/nonischemic cardiomyopathy and primary prevention/secondary prevention), the mode of pacing and appropriate/inappropriate shocks, the complications, outcomes, and quality of life (QOL) and to determine other outcomes, for example, rehospitalization rates, delivery of ICD shocks, drug compliance, electrical storm, and deaths, if any.

Methods

This descriptive cross-sectional study was carried out for a period of 1 year at the Department of Cardiology, PGIMER, Chandigarh. A total of 64 patients (20.31% – females and 79.69% – males) were implanted ICD during the period of July 1, 2016–June 30, 2017. The mean age of patients undergoing ICD implant was 54.39 ± 11.54 years (the mean age of males was 54.61 ± 11.41 years, whereas the mean age of female patients was 53.54 ± 12.51 years). Of the 64 ICD implantations, 49 (76.56%) patients had CAD/ischemic cardiomyopathy, whereas 15 (23.44%) patients had nonischemic indications. The QOL of patients undergoing ICD implant was assessed at 6 months with the WHOQOL-BREF questionnaire and compared with controls. The study was conducted according to the ethical principles stated in the latest version of the Helsinki Declaration and the applicable guidelines for good clinical practice. Ethics approval was obtained from the Institutional Ethics Committee, and written informed consent was obtained from individual patient.

All data were presented as mean ± standard deviation; unpaired Student's t-test was applied for between-group comparisons of normally distributed continuous variables. P ≤ 0.05 was accepted as statistically significant.

Results

Of the 64 patients included in the study, 43 (67.19%) patients received ICD for the primary prevention, whereas 21 (32.81%) patients received it for the secondary prevention. The clinical profile of ICD recipients is shown in [Table 1]. Nonischemic indications included dilated cardiomyopathy (DCM) in 10 patients (15.63%) and hypertrophic cardiomyopathy/hypertrophic obstructive cardiomyopathy in 4 patients (6.25%). Six patients presented as NYHA Class IV initially but subsequently improved to Class II or III after hospitalization and treatment. Of the 64 ICD recipients, mode of pacing was VVI and VVIR in 62 (96.88%) and 2 (3.13%) patients, respectively.

Table 1: Clinical profile of implantable cardioverter-defibrillator recipients at baseline

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Outcomes in implantable cardioverter- defibrillator recipients

Complications

Of the 64 ICD implants, early complications (<6 weeks) of pocket site infection (1.56%), lead dislodgement (1.56%), and thrombophlebitis of the left upper limb (1.56%) were seen in 3 (4.69%) patients. Thirteen patients were lost to follow-up, so 51 patients were followed up for 6 months. None of them developed any device-related complication.

Mortality

There were 4 (7.84%) deaths in ICD recipients, with 2 (3.92%) being SCD and 2 from worsening of heart failure within 6 weeks. In the control group, 8 (15.69%) patients died within 6 months, with 5 (9.8%) being SCD.

Other outcomes

Five (9.8%) patients had records of VT storm and 10 (19.6%) patients were readmitted due to worsening of heart failure (15.68%). [Table 2] presents the baseline clinical characteristics of the 51 ICD recipients who were followed up for 6 months as compared to controls.

Table 2: Demographic and clinical profile of implantable cardioverter-defibrillator recipients and controls

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The comorbidities were similar in both the groups. While CAD/ischemic cardiomyopathy was present in 76.47% of patients in the control group, type 2 diabetes, hypertension, DCM, and chronic kidney disease were present in 31.37%, 41.18%, 17.65%, and 3.91% of patients, respectively. About 11.76% of patients in the control group had a documented history of VT. Patients with ICD implant were followed up, and QOL was assessed after 6 months by the WHOQOL-BREF questionnaire. A total of 5 patients with ICD implant were not included in the QOL assessment (4 patients died before 6 months and ICD was explanted in 1 patient). Therefore, 46 cases and 51 controls completed the WHOQOL-BREF questionnaire. Responses from each respondent were used to calculate raw scores in 4 domains, which were subsequently transformed using formula provided by the WHOQOL group and using SPSS WHOQOL-BREF syntax (IBM Inc., version 25). The QOL of patients in the ICD implant group was better as compared to controls in the domains of social relationship and environment, whereas it was worse in physical health and psychological domains, though the difference in all four domains of QOL was not statistically significant.

Implantable cardioverter-defibrillator interrogation data

Of the 51 patients followed up for 6 months, 4 patients died and 1 ICD was explanted. Of the remaining 46 cases, ICD interrogation data were collected for 37 cases. Nineteen (51.35%) patients had records of VT, whereas 3 (8.1%) had records of VF. A total of 43 antitachycardia pacing (ATP) therapies were delivered to 7 (18.9%) patients who were successfully terminated in 13 VT/VF episodes. In 2 (5.45%) patients, ATP triggered fast VT. A total of 49 ICD shocks were delivered to 5 (13.5%) cases with none of the shocks being inappropriate. Forty-five percent of the primary prevention recipients had one or more VT/VF episodes, whereas 80% of the secondary prevention recipients had VT/VF episodes. The success rate of ATP was 30.23%, whereas the success rate of ICD shocks was 95.92%. All 47 VT/VF episodes were terminated by shocks.

Discussion

This is a descriptive cross-sectional study of demographic and clinical profile as well as QOL and outcomes of patients undergoing ICD implantation. Various studies and registries from all over the world have reported the clinical profile and complications of patients undergoing ICD implants, but there is a paucity of data from India. In this study, the mean age of patients receiving ICD implant was 54.39 ± 11.54 years, with 79.69% of males and 20.3% of females. In a study by Kanoupakis et al.,^[13] there were 757 (88.6%) males and 97 (11.4%) females, with a mean age of 62.9 ± 11.6 years. In another study by Zhang et al.,^[14] males outnumber females (80% vs. 20%). As per the National ICD Registry of the USA,^[15] the mean age of recipients was 67.3 ± 13.0 years, with 347 (0.13%) implants reported in pediatric patients younger than 18 years. Hence, our data indicate that the mean age of patients receiving an ICD implant in India is less as compared to Western data. One possible explanation for this difference may be the occurrence of CAD about a decade earlier in Indian population.

In the present study, majority of patients (67.19%) were implanted ICD for the primary prevention. Similarly, in a study by Kanoupakis et al.,^[13] of total 854 recipients, 623 (73%) received ICD for the primary prevention. Of these 854 patients, 490 (57.4%) patients had ischemic cardiomyopathy, 265 patients (31%) had nonischemic DCM, 41 (4.8%) had hypertrophic cardiomyopathy, and 58 (6.8%) patients had a primary electrical disorder (channelopathy). In addition, as per the National ICD Registry of the USA, of a total of 259,395 ICD recipients, 49.4% of recipients had a history of myocardial infarction,^[15] whereas 33.5% had nonischemic cardiomyopathy. Of these, 73.8% of patients received ICD as a primary prevention, whereas 22.5% of patients received as a secondary prevention.

In all 64 ICD recipients of the present study, mode of bradycardia pacing was VVI/VVIR. Antibiotic prophylaxis was routinely given with intravenous teicoplanin and ciprofloxacin or amikacin for 5 days. After 5 days, patients were continued on oral amoxicillin-clavulanic acid for another 5 days. Only 1 (1.56%) patient developed pocket site infection necessitating ICD explant. One (1.56%) patient developed thrombophlebitis of the left arm, which was improved with antibiotics, and 1 (1.56%) patient developed lead dislodgement immediate postprocedure. As per the National ICD Registry of the USA,^[15] procedure-related complications occurred in 2.16% (total of 5675) of recipients, of which major procedural complications occurred in 1.56% of recipients. Lead-related complications occurred in 1.54% of new implants with lead dislodgement being most common occurring in 1.45% of recipients, followed by lead perforation in 0.09% of recipients. Thirteen (1.5%) patients developed a device-related infection, requiring device extraction or revision. Lead-related complications were also noted in 49 (5.7%) patients in another study.^[13] Similarly, 4 (2.2%) recipients developed pocket site infection at a median of 440 days in a study by Sarda et al.^[16] None of these four cases required device explant and were managed conservatively with intravenous antibiotics and surgical debridement. Lead-related complications were noted in 1.65% of recipients, with lead dislodgement in 1.1% of recipients.^[16]

In the present study, of the 51 patients followed up for 6 months, 4 (7.84%) patients died and 1 (1.96%) ICD was explanted due to pocket site infection. Of the remaining 46 cases, ICD interrogation data were collected for 37 (80.4%) cases. Nineteen (51.35%) patients had episodes of VT documented, whereas 3 (8.1%) had episodes of VF. A total of 43 ATP were delivered to 7 (18.9%) patients. ATP successfully terminated 13 VT/VF episodes (success rate: 30.23%). A total of 49 ICD shocks were delivered to 5 (13.5%) cases with none of the shocks being inappropriate. ATP triggered fast VT in 2 (5.4%) patients. Another study by Wathen et al. had compared ATP versus shocks in patients with rapid VT. ATP successfully terminated 72% of fast VT episodes.^[17] Data from the National ICD Registry of the USA^[15] suggests that device replacements therapy (ATP/shocks) was being used in 25.2% of recipients. The success rate of ATP was 77.3%, whereas that of shocks was 14.9%. Hence, it is clear from our study that ATP successfully terminated VT episodes without the need for shocks. The success rate of ATP (about 30%) was lower than other similar studies. However, in another study by Daubert et al., inappropriate shocks occurred in 11.5% of recipients, whereas the most common precipitating factors were atrial fibrillation (44%), supraventricular tachycardia (36%), and abnormal sensing (20%).^[18]

In our study, QOL of patients undergoing ICD implant was better after 6 months as compared to controls in the domains of social relationship and environment, whereas it was worse in physical health and psychological domains, though the difference in all four domains of QOL was not statistically significant. In a systematic review by Tomzik et al.,^[19] of five randomized controlled trials (RCTs) and one cohort study, two RCTs showed improved QOL in ICD recipients as compared to those on medical therapy. A study by Namerow et al. conducted on 262 ICD recipients showed worsening in QOL as compared to nonrecipients, with even decremental effects with ICD shocks.^[20] In another study by Schron et al.^[21] (AVID trial), the QOL of 416 ICD recipients was similar as compared to nonrecipients, with shocks worsening QOL. Similarly, another study by Wathen et al.^[17] including 634 ICD recipients as a primary prevention had shown better QOL. In our study, a total of 4 (7.84%) patients with ICD implant died, with SCD occurring in 2 (3.92%) patients. Two of these recipients died within 6 weeks from worsening heart failure. Among 51 controls, 8 (15.69%) patients died, with SCD occurring in 5 (9.80%) patients. In contrast to other studies, the difference in cases and controls was not statistically significant in terms of SCD. The small sample size may be the reason for this observation. Our study had several limitations: first, the sample size was small and 13 (20.3%) patients were lost to follow-up. Second, QOL assessment is subjective and 6-month duration is probably small to assess change in QOL. Third, three patients received shocks, whereas impact of shock on QOL and its psychological consequences needs larger and longer duration studies.

Conclusion

Our findings suggest that majority of ICD implantations are for ischemic cardiomyopathy and for the primary prevention with complications within acceptable limits. There is a significant reduction in SCD mortality with no deterioration in QOL and all shocks being appropriate. With the advancement in technology, ICD implantations have become much safer. However, considering the burden of CAD in this part of the country, large multicenter prospective controlled studies are needed to determine factors associated with survival benefits of ICD implantation for both the primary and secondary prevention.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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