|Year : 2021 | Volume
| Issue : 1 | Page : 47-53
One year outcomes following orthotopic heart transplantation at a tertiary care center in India
Syed Shamayal Rabbani1, Sarvesh Pal Singh1, Sandeep Seth2, Anurag Goyal1, Manoj Kumar Sahu1, Milind P Hote1
1 Department of Cardiothoracic and Vascular Surgery, All India Institute of Medical Sciences, New Delhi, India
2 Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India
|Date of Submission||27-Aug-2020|
|Date of Decision||04-Mar-2021|
|Date of Acceptance||12-Mar-2021|
|Date of Web Publication||24-Apr-2021|
Sarvesh Pal Singh
Room No. 5, 7th Floor, Department of Cardiothoracic and Vascular Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110 029
Source of Support: None, Conflict of Interest: None
Introduction: Cardiac transplantation remains the gold standard for end stage heart failure. Even after 25 years, the progress of heart transplants in India has not been as expected, especially in the public sector. Till recently, ours was the only government hospital in India with a successfully running heart transplant program. This study's primary objective was to evaluate the 1-year survival of heart recipients in the past 5 years at our center and risk factors associated with early mortality. The secondary objective was to assess the correlation between per capita income and quality of life (QOL). Methodology: A retrospective analysis of records of 40 transplant patients, performed between June 2014 and June 2019 at our center, was done to calculate 1-year survival and evaluate risk factors for mortality. The following risk factors were analyzed for a significant correlation with mortality-infections, primary graft dysfunction (PGD), allograft rejection, ischemia time, and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) score. Adults (>18 years of age) who are in the current follow-up (n = 21) were interviewed for the evaluation of their per capita income and QOL. A correlation was sought for between per capita income and QOL. Results: The mean age of patients was 31.2 ± 12.7 years. The 1-year survival of patients transplanted during 2014–2015 and 2016–2019 was 65% and 85%, respectively. None of the risk factors studied correlated with mortality. The most common cause of death in the 1st year following transplant was an infection. A total ischemia time of more than 240 min, higher preoperative PA pressures, and INTERMACS score ≤2 are significant risk factors for developing PGD. The mean monthly per capita income of the 21 patients, interviewed for QOL, is ₹7142 ± 3050. The cost of heart transplant for the first 2 years (including surgical expenses) is ₹997,760 ± 104,751 rupees at our institute, and the current mean monthly spending for medicines is ₹15,214 ± 5041. Conclusion: The 1-year survival of patients transplanted during 2014–2015 and 2016–2019 was 65% and 85%, respectively. There was no correlation between infections, PGD, allograft rejection, ischemia time, INTERMACS score, and mortality. The QOL of heart recipients, from economically weaker sections, is similar to that of India's general population. There is no correlation between per capita income and QOL after a heart transplant.
Keywords: Heart, one, outcomes, transplant, year
|How to cite this article:|
Rabbani SS, Singh SP, Seth S, Goyal A, Sahu MK, Hote MP. One year outcomes following orthotopic heart transplantation at a tertiary care center in India. J Pract Cardiovasc Sci 2021;7:47-53
|How to cite this URL:|
Rabbani SS, Singh SP, Seth S, Goyal A, Sahu MK, Hote MP. One year outcomes following orthotopic heart transplantation at a tertiary care center in India. J Pract Cardiovasc Sci [serial online] 2021 [cited 2021 Jun 22];7:47-53. Available from: https://www.j-pcs.org/text.asp?2021/7/1/47/314481
| Introduction|| |
Cardiac transplantation remains the treatment of choice for heart failure patients who remain symptomatic despite optimum medical management., Following the first successful human to human heart transplant by Christian Barnard on December 3, 1967, a new and exciting chapter of cardiac surgery opened up.
The International Society of Heart and Lung and Transplantation (ISHLT) registry has registered 89,000 transplants worldwide since 1984, although the actual number may be quite high owing to under-reporting.,
The first successful heart transplant in India was done at All India Institute of Medical Sciences, New Delhi, on August 3, 1994, and this patient lived for 14 years' posttransplant. The longest surviving recipient of a heart transplant in India is from our institute and has completed 20 years. Even after 25 years, the progress of heart transplants in India has not been as expected, especially in the public sector., The studies analyzing the outcomes and thereby suggesting improvements in heart transplantation have been very limited in our country. Till recently, ours was the only government hospital in India with a successfully running heart transplant program.
The majority of patients visiting our hospital belong to lower socioeconomic strata, and therefore, a significant percentage of our transplant recipients belong to economically weaker sections (EWS) of the society.
This study's primary objective was to evaluate the 1-year survival of heart recipients in the last 5 years at our center and risk factors associated with early mortality. The secondary objective was to assess the correlation between per capita income and quality of life (QOL) after heart transplant.
| Methodology|| |
A retrospective analysis of records of 40 transplant patients, done between June 2014 and June 2019 (5 years), was done after obtaining permission from the institutional ethics committee. The ethics committee's clearance number is IECPG/777/12/2019.
Adults (>18 years of age) who are in the current follow-up (n = 21) were interviewed for evaluation of their per capita income and QOL. Patients who refused consent were not included in the study. A correlation was sought for between per capita income and QOL.
The preoperative evaluation, immunosuppression, and prophylaxis regimens were followed as per the institutional protocols. The standard management protocol has been published earlier.
All patients underwent an orthotopic heart transplant. The donor heart was harvested either from within the city (30 km radius) or from outstation (maximum distance covered– 900 miles/3.5 h of flying time. For heart harvesting, standard sternotomy, great vessel dissection, cardioplegia cannula insertion was done. Once other organ harvesting teams are ready, the inferior vena cava (IVC), right and left superior pulmonary veins are incised to vent the heart. The superior vena cava (SVC) is tied, aortic cross-clamp is applied, and 12 mg Adenosine is administered into the aortic root. Immediately 1.5 l of custodial cardioplegia (4–8°C) is administered over 7–8 min.
Then, the heart is explanted, cutting IVC, SVC, aorta, pulmonary artery (PA), and the left atrial cuff sequentially. The organ is then stored in a sterile organ bag containing cold Custodiol solution (500 ml). This bag is then placed in a second bag containing a large amount of ice slush. This second bag is then placed in a third bag before being transported in the organ box. Once the donor heart reaches the recipient operation theater, if the ischemia time has exceeded 120 min (which is almost always, for outstation harvests), the heart is immediately perfused with 1 L of cold Custodial solution. By this time, another surgical team has already placed the recipient on cardiopulmonary bypass (with high angled SVC cannulation, very low IVC cannulation, and high aortic cannulation, SVC and IVC have been looped and snugged) and then aortic cross-clamp is applied, and recipient cardiectomy is done (SVC, aorta, PA, IVC, and left atrium – leaving an appropriate size cuff).
The donor heart is placed in an anatomical position and then flipped over 180 degrees to the first assistant side. Sequential chamber and great vessel anastomosis are then done. The left atrial cuff is sutured with 3-0, 120 cm prolene (final stitches are passed around a right superior pulmonary vein vent), IVC with 5-0 prolene, and aorta with 4-0 prolene. Subsequently, the aortic cross-clamp is removed, and PA and SVC are anastomosed off clamp with 5-0 prolene sutures. The whole operation is performed at 32 degrees hypothermia, and the patient is weaned off cardiopulmonary bypass after placing 4 pacing wires (2 each in the right atrium and ventricle). Mechanical circulatory support is used if a moderate amount of inotropes are insufficient to maintain desired cardiac output.
After discharge from the hospital, recipients are followed up every week, till 1-month posttransplant; then, every 15 days, till 6-month posttransplant; then every month, till 1-year posttransplant and every 3 months, after that.
The first biopsy is done within 10–14 days of transplant, then one biopsy between 3 and 6 months, and then at 1 year. After that, endomyocardial biopsy and computed tomography (CT) angiography are performed every year. The biopsy is performed in symptomatic patients suspected of developing rejection as and when required.
The following risk factors were analyzed for a significant correlation with mortality-infections, primary graft dysfunction (PGD), allograft rejection, ischemia time (time from the application of aortic cross-clamp in donor heart to release of aortic cross-clamp in recipient), and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) score. Infections were diagnosed based on clinical presentation, laboratory parameters (total leukocyte count, C reactive protein, erythrocyte sedimentation rate, Procalcitonin, radiological features (chest X-ray, and high-resolution CT of chest), serology, and cultures. A positive culture report and/or gram stain for bacteria from a representative sample was considered positive. For fungal infections 1,3 β, D Glucan, and N-Galactomannan levels proved useful. The diagnosis and grading of PGD and rejection were made as per ISHLT criteria.,
Consequent to the changes made in our management protocols in 2016, a comparison of 1-year survival between 2014-2015 and 2016-2019 was done.
Quality of life assessment
The Medical Outcomes Study Short-Form Health Survey (SF-36) is a widely used generic health-related QoL instrument consisting of 36 questions and measuring health in eight dimensions: Physical functioning, role limitations due to physical health problems (RP), bodily pain, social functioning, general mental health covering psychological distress and emotional well-being (MH), role limitations due to emotional problems (RE), vitality, energy, and fatigue (VT), and general health perceptions. An additional single item assesses change in the respondent's health over the past year (HC).,,, An Indian adaptation of the questionnaire was used for easy comprehension by the respondents.
The statistical analyses were performed using Statistical Package for Social Sciences (SPSS), version 25 (International Business machines, New York, USA). Univariate analysis of risk factors was performed. A Chi-square test was applied to evaluate categorical variables (diabetes mellitus, hypertension, ischemia time, and infections), while a Mann–Whitney U test was applied for continuous variables (mean PA pressures, age, INTERMACS score). A comparison of survival analysis was done using Kaplan–Meier (K-M) curves with Log rank (Mantel-Cox) and Breslow (Generalized Wilcoxon) tests.
| Results|| |
Forty patients underwent OHT at our center from June 2014 to June 2019 (5 years). The follow-up of all the patients was 100%. The mean age of patients was 31.2 ± 12.7 years. The most common etiology for heart failure was DCMP. Out of 40, 8 patients were INTERMACS ≤2 at the time of the transplant, with one being on ECMO. Three patients had undergone nontransplant cardiac surgeries earlier. The preoperative details of the patients are enlisted in [Table 1].
The K-M survival curves for 1-year survival in our patients from 2014 to 2015 and 2016 to2019 are shown in [Figure 1]. The 1-year survival obtained from these curves showed significant (P = 0.001) improvement during 2014–2015 (65%) and 2016–2019 (85%). The most common cause of death in 1st-year posttransplant was an infection. The details of 10 patients who died within the 1st year of transplant are described in [Table 2]. Out of the 10 patients who expired, 4 died due to infections. Two had bacterial pneumonia (Klebsiella pneumoniae and Pseudomonas aeruginosa), one had bacterial and fungal pneumonia (Klebsiella pneumoniae and Aspergillus fumigatus) and one patient developed sepsis secondary to fungal endophthalmitis. None of the risk factors studied correlated with mortality. Even with a Cox proportional hazard model there was no correlation between the potential risk factors for mortality and death. The recipient gender did not correlate with mortality.
|Figure 1: Kaplan–Meier curves for 1 year survival after heart transplant in 2014–2015 and 2016-2019.|
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Expenditure and per capita income
Out of a total of 40 patients included in the study, 21 adult patients were assessed for their per capita income. Twelve out of them are earning members of their families. The mean monthly per capita income is ₹7142 ± 3050 for these 21 patients.
The cost of heart transplant for the first 2 years (including surgical expenses) was ₹997,760 ± 104,751 at our institute. This cost includes pretransplant workup, immunosuppressive drugs, and antimicrobial prophylaxis for the first 2 years, monitoring and treating complications (rejection, infection), endomyocardial biopsies for the first 2 years, and treatment with Extracorporeal membrane oxygenation (ECMO) once. The current mean monthly expenditure for medicines is ₹15,214 ± 5041. Out of the total 21 assessed patients, Government agencies sponsored the surgeries of 16 patients and 9 receive financial assistance for monthly medicine expenditures. Four patients have relocated to places near our institute for easier follow-up. Eleven patients live in rented houses while remaining has their own accommodations. Further details are shown in [Table 3].
Quality of life
Twenty-one adult patients were assessed for their symptoms based on NYHA classification and QOL-based on a MOS SF-36 score questionnaire. All the patients are in NYHA Class I. The patients' mean scores for the MOS SF36 questionnaire are shown in [Table 4]. There was no significant correlation between QOL scores and per capita income, age, or gender.
Primary graft dysfunction
Seven of our patients developed moderate or severe PGD. Out of these 3 patients expired. On univariate analysis, increased preoperative PA pressures (mean 29.65 ± 8.45 mmHg in non-PGD vs. 39.64 ± 5.87 mmHg in PGD group; P = 0.01), total ischemia time >240 min (P = 0.01) and low INTERMACS score (≤2; n = 8; P = 0.01) were found to be significantly associated with PGD.
Out of 40 patients, we had 8 patients who had one or more ≥Grade 2 cell-mediated rejection (CMR) episodes and 3 patients were diagnosed with antibody-mediated rejection. One patient with CMR was treated with anti-thymocyte globulin for refractory right ventricular failure. One patient was diagnosed with coronary allograft vasculopathy (CAV) postmortem.
Seven patients developed renal dysfunction requiring hemodialysis in the postoperative period. Recipient age (P = 0.87), hypertension (0.94), and diabetes mellitus (0.77) were not associated with the development of renal dysfunction.
Two patients developed subdural hematomas, with one of them requiring surgical intervention in the form of multiple evacuations. Four patients developed convulsions in the postoperative period. None of them had any history of convulsions/neurological disease in the preoperative period.
Infections were the most common complication in our transplant recipients. In this article, we have considered only those infections which required hospitalization of the patient. Certain infections were managed in outpatient clinics by our heart transplant team. Eleven patients developed major infections at least once in their follow-up, requiring hospitalization for evaluation and management. The details of these infections are shown in [Table 5].
Three patients developed steroid-induced myopathy while 4 developed avascular necrosis of femoral head. Two patients with avascular necrosis of the femoral head underwent hemiarthroplasty. Out of 5 patients with behavioral issues, 2 were diagnosed with steroid-induced psychosis (treated with Olanzapine) and 2 with depression mandating anti-depressant medications (Citalopram). One patient developed vocal cord palsy in the immediate postoperative period leading to aspiration pneumonitis. One patient developed calculous cholecystitis in the postoperative period and underwent laparoscopic cholecystectomy at our center. Six patients developed tacrolimus-induced hyperkalemia diagnosed on a routine follow-up visit and responded well to dose modification. One patient who presented with urinary tract infection-like features multiple times was diagnosed with bladder outlet obstruction and was treated for the same endo-urologically.
| Discussion|| |
The number of transplants per year has been steadily rising in India with time. Still, a wide gap remains in the number of transplants being done in the private sector compared to the public sector. The lack of proper infrastructure, a paucity of donors, inefficient referral system and an excessive load of nontransplant surgeries are some of the causes for unsatisfactory growth transplant programs in India.,
The organ donation rates are quite low in Northern India, contributing to the lower number of transplants. Forty transplants were done in the 5 years from June 2014 to June 2019 compared to 31 in the 20 years from August 1994 to June 2014. This statistic is comparable to the majority of transplant centers in the world. As per the ISHLT registry, 53% of transplant centers performed between 5 and 19 transplants each year. Only 27% centers performed 20 or more heart transplants per year. The National Organ and Tissue Transplant Organization has played a significant role in the growth of a national heart transplant program in India.,
The most common indication for transplant was DCMP (62.5%) followed by ICMP (22.5%). DCMP is a common indication for a heart transplant in the world. Only one of our patients had MCS in the preoperative period. Worldwide more than 50% of transplant candidates are bridged with MCS, and increasing day by day.,, MCS bridge therapy has been very instrumental in improving the overall outcomes in heart failure. Most studies indicate no adverse outcomes of preoperative MCS on early and mid-term survival postheart transplant.,,,,
The 1-year survival for 40 patients, transplanted between June 2014 and 2019, was 75%. ISHLT reports a 1-year survival rate of 85%. Petit et al. identified a relationship between center volume and mortality of transplantations in their meta-analysis. Arnaoutakis et al. reviewed 10-year UNOS (United Network for Organ Sharing) data and classified the centers into low (<7), medium,,,,,,,,, and high (>15) volume centers. They inferred that annual institutional volume influenced mortality. They also recorded a higher mortality of high-risk patients at low volume centers. The detailed analysis of data from our institute showed a significant increase in the 1-year survival of transplant recipients over last 5 years. In 2014, a change in institutional policy allowed travel by commercial flights for inter-city harvesting of donor hearts. Therefore, 20 heart transplants were performed in 2014 and 2015 with 1-year survival of 65%. To understand the cause of a lower 1-year survival an extensive review of our protocols for antimicrobial prophylaxis, immunosuppression and patient selection criteria were conducted. The heart failure and transplant team were reconstituted with greater participation from cardiac surgical intensivists and heart failure nurses. The current 1-year survival at our center for heart transplants performed between 2016 and 2019 is 85% which is the same as reported by ISHLT.
Infections were found to be the most common cause of death in our patients in 1st year of posttransplant. More so, infections continue to be the most common cause of mortality (34%) worldwide posttransplant between the 30-day and 1-year period. By far, infections are the most common complication following heart transplant, with one and 5-year incidence being 65% and 85%, respectively.,, The risk of significant life-threatening infections is specifically higher in the 1st year posttransplant due to maximum immunosuppression and corticosteroid dosage in the initial period. Infections pose a significant problem for us due to the weak financial status of many of our patients. Financial restrictions result in overcrowding at home, less hygienic living conditions, the predominant use of public transport, difficulty in follow-up, noncompliance with infection prevention practices, and difficulty following home-based treatment protocols, thereby increasing the rate of infections and hospital admissions.
As per ISHLT criteria, 17.5% of our patients developed moderate or severe PGD. The incidence of PGD has been documented between 13.9% and 36%. [18,23-25] The RADIAL score comprising RAP ≥10 mmHg, recipient age ≥60 years, diabetes mellitus, inotrope dependence, donor age ≥30 years, and length of ischemic time ≥240 min has been validated in multivariate analysis to predict the risk of developing PGD., In our study, a total ischemia time of more than 240 min, high preoperative PA pressures, and INTERMACS score ≤2 were risk factors for PGD.
There were no hyperacute rejections reported in our patients. Eight patients had one or more episodes of ≥Grade 2 CMR, while three patients had AMR. In a study by Sai et al., ACR incidence after the 1st year is quite low. Four of our patients developed a rejection in the 2nd year after transplant. One had a sudden arrhythmic event on the day of his admission, from which he could not be revived. The other three patients partially responded to therapy but finally succumbed to their pathology. On root cause analysis, noncompliance was the cause of rejection for three patients and switching to other immunosuppressive drugs (Tacrolimus to Cyclosporine) for the fourth one. All 4 of them had subtherapeutic levels for Cyclosporine or Tacrolimus before rejection.
CAV remains a significant cause of death between 1- and 3-years' posttransplant and affects 7.8% patients within 1 year.,, The risk factors for CAV are age, gender, obesity, dyslipidemia, diabetes mellitus, hypertension, smoking, acute rejection, and histocompatibility mismatch at the time of transplant. One of our patients who had CAV was 47 years old, known hypertensive, diabetic, and had one episode of ACR within 1st year of transplant.
The overall QOL has been excellent posttransplant, and all the patients have good functional status. Those patients who were employed before the surgery have resumed their occupations. A questionnaire-based scoring of SF-36 scores showed a significant change in the health condition from preoperative to postoperative period. SF-36 is one of the most widely used health-related QOL score in the world. The item-validity and reliability of the score has been validated in multiple international and Indian studies., SF-36 instrument has been translated, adapted, and validated in multiple languages.,, The scores obtained in our patients are at par with adult general population scores in the USA and India. Heart transplantation results in a significant improvement in the QOL.,,,, Multiple international studies have demonstrated significant longitudinal and cross-sectional early and long-term improvement in QOL following a heart transplant.,, To the best of our knowledge, there is no study on QOL following OHT in Indian patients. There was no correlation found between QOL and per capita income of patients in our study.
Many of our patients are from EWS of society. The burden of the cost of surgery and monthly expenditure is a significant factor discouraging transplants in the public sector. At our institute, the expenditure for a heart transplant, for economically weak patients, is borne by the government through various schemes.
Ayushman Bharat is the flagship scheme of Government of India, where medical treatment up to 5 lakh rupees per year is provided to each family free. As per our study, the cost of heart transplant for the first 2 years (including surgical expenses) is ₹ 9,97,760 ± 1,04,751 at our institute. The current mean monthly expenditure for medicines is ₹ 15214 ± 5041. Therefore, it is feasible to include heart transplant surgery in the current list of PMJAY scheme. This inclusion will go a long way in improving treatment outcomes for end-stage heart failure in India.
Limitation of the study
Ours is a single-center study with small number of patients. The inability to establish a correlation between mortality and studied risk factors maybe because of the small sample size.
| Conclusion|| |
The 1-year survival of patients transplanted during 2014-2015 and 2016-2019 was 65% and 85%, respectively. There was no significant correlation between infection, PGD, allograft rejection, ischemia time, INTERMACS score, and mortality. A total ischemia time of more than 240 min, higher preoperative PA pressures, and INTERMACS score ≤2 were found to be significant risk factors for developing PGD. The QOL of heart recipients, from EWS, is similar to that of India's general population. There was no correlation between per capita income and QOL after a heart transplant.
The ethics committee's clearance number is IECPG/777/12/2019.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]