https://orcid.org/0000-0003-3505-2444
Figures
Abstract
Large-scale analyses of surgical outcomes after surgical pulmonary valve replacement (sPVR) as part of re-do surgery in adults with congenital heart disease (ACHD) are rare. Therefore, we present our outcomes of sPVR in ACHD patients over the last decade and demonstrate our standardized surgical approach. All ACHD patients who underwent sPVR between January 2013 and August 2022 were included. Primary diagnoses, peri-operative data, post-operative echocardiography, pre- and post-operative RV MRI and in-hospital mortality were examined. Pre- and postoperative MRI parameters were compared using paired testing. Standardized surgery was documented. Normality of continuous variables was tested using Shapiro-Wilk test. 79 patients (male 59.5% (n = 47), 71 re-operations (89.9%)) at a median age of 41.7 (52.2–28.8) years were included. Main underlying disease was Tetralogy of Fallot (TOF; n = 47, 59.5%). After removal of degenerated valve/conduit parts, right ventricular outflow tract (RVOT) patch augmentation and implantation of a larger stented bioprosthesis (25mm in 78.5%) were conducted. In 57% of cases, concomitant surgery was performed (mainly tricuspid valve surgery: n = 28, 35.4%). 25 patients (31.6%) were operated with beating heart technique. Echocardiographic outcomes showed no moderate or severe insufficiency (median Vmax of 2 m/s (2.3–1.77 m/s)) upon discharge. Available MRI data showed significantly lower indexed RV-EDV (p = 0.0006) and RV-ESV (P = 0.0017) after surgery. In-hospital mortality was 5.1% (n = 4). SPVR is a safe therapeutic option with low surgical risk and satisfying post-operative results. It can serve as a solid therapeutic option for patients who need future valve-in-valve interventions.
Citation: Peivandi AD, Martens S, Gion A, Rukosujew A, Martens S (2024) Pulmonary valve replacement—A 10-year single-center surgical experience in ACHD patients. PLoS ONE 19(10): e0310700. https://doi.org/10.1371/journal.pone.0310700
Editor: Redoy Ranjan, BSMMU: Bangabandhu Sheikh Mujib Medical University, BANGLADESH
Received: June 13, 2024; Accepted: September 4, 2024; Published: October 4, 2024
Copyright: © 2024 Peivandi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: All relevant data are within the paper and its Supporting information files.
Funding: The author(s) received no specific funding for this work.
Competing interests: The authors have declared that no competing interests exist.
Introduction
Pulmonary valve procedures in adults are rare and mainly affect adults with congenital heart disease (ACHD). Overall mortality rate of such procedures currently lies at 3.9% [1].
According to present literature, clinical outcomes of surgical pulmonary valve replacement (sPVR) in ACHD patients as part of redo surgery after TOF- correction shows low mortality rates as well as low needs for re-intervention [2, 3].
Prospective magnetic resonance imaging (MRI) investigations have shown that sPVR immediately initiates reverse remodeling processes. They continue for at least 3 years after surgery. This leads to an improvement in symptoms and a reduction of right ventricular (RV) volume [4]. In this regard, the right timing of surgery is essential for a successful remodeling process after sPVR [5].
The aim of this study was to analyze the clinical data of all ACHD patients who received sPVR at our institution during the last decade.
Material and methods
In this study, we analyze our operative data on sPVR in ACHD patients of the last decade retrospectively. In addition, we present our standardized surgical technique in this group of patients. Furthermore, available MRI and echocardiographic data is assessed.
We analyzed the clinical data of all ACHD patients who received sPVR at our institution from 01–2013 (mm-yyyy) to 08–2022 (mm-yyyy) retrospectively. Data was accessed for research purposes from 24-02-2023 (dd-mm-yyyy) to 09-04-2024 (dd-mm-yyyy). Primary diagnoses as well as peri-operative data, available pre- and post-operative RV MRI data, post-operative echocardiography and in-hospital mortality are shown. In addition, this study includes the introduction of a standardized approach for sPVR.
Statistical analysis
Patient characteristics and results were reported as either n (%) or median (IQR 3–1). Normality of continuous variables was assessed using Shapiro-Wilk test. Paired tests (Wilcoxon test, paired t-test) were used for statistical comparison of pre- and postoperative RV MRI data. Kaplan-Meier was used for medium- and long-term follow up analysis. MedCalc V 22.009 (MedCalc Software Ltd, Ostend, Belgium) was used for statistical analysis.
Results
Participants
After analyzing the data of all patients above the age of 18, who received sPVR at our institution at the given time period, 80 patients were identified. One patient presented with endocarditis without a history of congenital heart disease. This patient was excluded from the study.
Hence, 79 ACHD patients were included in our retrospective analysis. 59.5% (n = 47) of them were male. Median age was 41.7 (52.2–28.8) years. 71 patients (89.9%) had undergone previous surgery, mainly during childhood. 10 patients (12.7%) had undergone balloon valvuloplasty prior to surgery.
91.1% of the surgeries were elective in nature and only in 7 (8.9%) cases there was an urgent indication for operation. Main underlying congenital heart disease was TOF (n = 47, 59.5%). Main primary intervention was fallot correction (n = 39, 49.4%). Detailed patients’ characteristics are depicted in Table 1.
Pre-operative data and echocardiography
Main trigger for intervention was pulmonary insufficiency (n = 48, 60.8%), followed by combined pulmonary vitia (n = 23, 29.1%) and isolated pulmonary stenosis (n = 8, 10.1%).
Insufficiency was characterized as low grade in 6 patients (7.6%). 8 patients displayed moderate pulmonary insufficiency (10.1%), 3 had moderate-severe insufficiency (3.8%) and 54 patients (68.4%) had severe pulmonary insufficiency. In patients with pulmonary stenosis component present, 1 patient showed relative stenosis (1.3%), 4 patients showed low grade stenosis (5.1%), 2 patients had low to moderate stenosis (2.5%), 10 patients had moderate stenosis (12.7%) and 14 displayed high grade pulmonary stenosis (17.7%).
Median pre-operative maximum velocity of the pulmonary valve (Vmax) was 2.2 m/s (3.4–1.8 m/s).
Standardized surgical approach
Depending on pre-operatively assessed vulnerability (chest computed tomography (CT) or magnetic resonance imaging (MRI)), either peripheral cannulation or central cannulation after sternotomy was performed.
Taking into account individual adaptations depending on previous operations and surgical preference, the general surgical approach can be described as follows:
After re-entry of the RVOT, possibly degenerated patch material with remnant parts of the native pulmonary valve or the destructed conduit, was removed. To allow later valve interventions, RVOT was enlarged using a bovine patch. This made the surgical implantation of a larger stented bioprosthesis possible (Fig 1). In cases were operation was performed in beating heart technique (n = 25 (31.6%)), bicaval cannulation was used to achieve a total bypass. Transesophageal echocardiography was used for left heart bubble control during surgery and to ensure, that there was no shunt present.
Surgical data
Median duration of surgery was 283 (342–221) minutes. In 25 patients (31.6%), beating heart technique was used. Median primary extracorporeal circulation (ECC) time was 164 minutes (203–124). If surgery was performed in cardioplegic cardiac arrest, median primary X-clamp time was 91 (114.5–68) minutes. In 3 patients (3.8%) a second X-clamping was necessary. Mainly blood cardioplegia was used (n = 43, 5.4%) and applied antegrade (n = 36, 45.6%). Surgery was performed in mild hypothermia (33.5 (36–32) °C).
In 74 cases (93.7%), a stented bioprosthesis (PERIMOUNT, Edwards Lifesciences Corporation, Irvine, California, U.S.) was implanted. Large valve diameters (25 mm) were preferred in order to provide a basis for future valve-in-valve interventions (n = 62, 78.5%).
In 45 cases (57%) concomitant surgery was performed: tricuspid valve surgery (n = 28, 35.4%), atrial septal defect closure (n = 9, 11.4%), aortic valve replacement (n = 8, 10.1%), coronary artery bypass surgery (n = 6, 7.6%), replacement of the ascending aorta (n = 4, 5.1%), ventricular septal defect closure (n = 4, 5.1%), mitral valve surgery (n = 2, 2.5%), correction of pulmonary vein malformations (n = 2, 2.5%), Glenn operation (n = 1, 1.3%), aortic root reconstruction (n = 1, 1.3%), epicardial ablation (n = 1, 1.3%) and pacemaker probe removal (n = 1, 1.3%). Fig 2 shows the surgical result in a patient with pulmonary valve replacement and concomitant replacement of the ascending aorta. Surgical data is summarized in Table 2.
Outcome
In-hospital mortality in our collective was 5.1% (n = 4). 12 patients (15.2%) needed temporary renal replacement therapy after surgery. In 7 cases (8.9%) re-thoracotomy due to bleeding or tamponade was necessary. Deep sternal wound infection (DSWI) incidence was low (n = 1, 1.3%). Low cardiac output occurred in 3 patients (3.8%). 2 patients (2.5%) required an assist device. In 6 (7.6%) patients reintubation was necessary. 10 patients underwent tracheotomy (12.7%). Median ventilation time after operation was 7 hours (15.5–4). A detailed list of post-operative complications is given in Table 3. One year mortality was at 7% (number at risk: 56), five year mortality was 14% (numbers at risk: 28). Kaplan-Meier analysis is depicted in Fig 3.
Numbers at risk are given below the graph.
Post-operative echocardiography upon discharge
Echocardiographic data was available from 89.9% (n = 71) of patients. None of these patients displayed moderate or severe insufficiency upon discharge. Median maximum velocity of the pulmonary valve (Vmax) was 2 m/s (2.3–1.77 m/s).
Pre- and post-operative MRI data
Both pre- and post-operative MRI data was available from 27.5% (n = 22) of patients. Pre-operative median RV-EDV was 322.5 (370–242) ml compared to 189 (235–172) ml post-operatively (p = 0.0005). Post-operative RV-ESV (113 (126–83) ml) was also significantly lower than pre-operative RV-ESV (179.5 (198–118) ml) (p = 0.0011). These differences remained statistically significant when indexing volume to body surface area (BSA, [m2]): Median pre-operative indexed RV-EDV was 183.6 (202.2–131.3) ml/m2 compared to median post-operative indexed RV-EDV with 106.9 (122.1–92) ml/m2 (p = 0.0006). Median pre-operative indexed RV-ESV was 90.9 (117.3–71.1) compared to median post-operative indexed RV-ESV with 60.4 (64.2–47.6) (p = 0.0017). No significant change was found in RV-EF (p = 0.7859).
Discussion
Due to major advances in both diagnosis and treatment options of congenital heart defects, which used to have lethal consequences in earlier times, most affected individuals reach adulthood nowadays [6]. Therefore, the cardiac care of ACHD patients has become increasingly important in recent years and specialized care centers have been established.
As therapeutic options for pulmonary valve replacement (PVR) continue to evolve and technologies advance, individual treatment strategies, developed through a collaboration of heart surgeons and (pediatric) cardiologists, become increasingly important. In view of a raising number of ACHD patients, a lifelong strategy to minimize necessary re-do procedures should be the common goal [7].
In sPVR, pericardial bioprostheses have delivered satisfying short- and long-term results [8, 9]. Due to the low pressure physiology of the right heart, correction with mechanical valves (MV) should be avoided. MV carry a high risk of valve thrombosis [10]. Additionally, a bioprosthesis can provide the basis for future valve-in-valve interventions as part of a long-term treatment strategy. From this background, we mainly used stented bovine pericardial bioprostheses (Perimount) with large diameter (25 mm) for pulmonary valve replacement in our cohort of patients.
Our described surgical technique involving a patch enlargement of the RVOT allows a standardized valve implantation comparable to the technique used for surgical aortic valve replacement (sAVR). An advantage of sPVR can also be seen in the performance of concomitant surgery. In our cohort, this was necessary in 57% of cases. This certainly contributed to the relatively long ECC time (164 minutes (203–124)) that can also be explained by peripheral cannulation before sternal re-entry.
Previously conducted studies have shown low mortality rates for sPVR after Fallot correction: An analysis of 21 patients receiving sPVR after Fallot correction showed a 30-day-mortality of 0%. Their cohort was much younger and concomitant surgical procedures were only performed in 28.6% of cases [11]. In another younger collective of 131 patients (14.8 vs. 42 years) who had previously undergone TOF repair, Jang et al. reported no early or late deaths [12]. Lee et al. assessed the outcomes of 61 patients after redo sPVR. They reported a 5-year-survival rate of 94.8% and a 10-year-survival rate of 83.7% [13]. In a meta-analysis of 48 studies, including 3,118 patients pooled 30-day mortality of PVR after operative repair of TOF was 0.87% and pooled 5-year mortality was at 2.2% [3]. We observed mortality rates of 5.1% (in-hospital), 7% (one year follow-up) and 14% (five year follow-up).
In light of different mortality rates, one should take a closer look at risk factors for mortality. For this purpose Jain et al. conducted a multivariate analysis and identified an age greater than 40 years (odds ratio 9.89) and concomitant surgery (odds ratio 6.65) as risk factors for mortality after sPVR in adults with previously corrected ToF [14]. In the wake of 57% (n = 45) concomitant operations and a median patient age of 41.7 (52.2–28.8) years, the in-hospital mortality rate of 5.1% (n = 4) in our cohort can be explained.
Post-operative echocardiographic data showed excellent short-term results with no moderate or severe insufficiency upon discharge. This rate is in line with results reported in literature [15].
Significantly decreased RV-ESV and EDV have similarly been reported in previously conducted MRI studies [16]. No significant RV-EF differences are also in line with literature, as regurgitation and shunting were not taken into account during calculation [16].
Different operative techniques have been proposed for sPVR. The common basis is seen as an implantation of a large diameter bioprosthesis [17]. Our surgical approach underlines this aspect, as we mainly used 25 mm bioprostheses.
Conclusion
Our study shows that SPVR with our surgical approach, can be performed safely, with an acceptable in-hospital mortality rate and satisfying post-operative results in ACHD patients. It can serve as a solid therapeutic option for patients who may be in need of future valve-in-valve interventions.
Limitations
This study is a single-center retrospective analysis. Multi-center collaboration can help to enhance the generalizability of the findings in the future. The analysis mainly focusses on short-term post-operative results. Long-term data on valve function, thrombosis, infection rates, and the need for reintervention remains to be assessed in future studies. The MRI study reflects only a small fraction of the study population. This is mainly due to inconsistent indications and collected parameters for MRI. Therefore, generalizations should be drawn with caution. To increase the MRI follow-up rate in future studies, standardized protocols for ACHD patients undergoing sPVR are desirable.
References
- 1. Beckmann A, Meyer R, Lewandowski J, Markewitz A, Blaßfeld D, Böning A. German Heart Surgery Report 2021: The Annual Updated Registry of the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg. 2022;70(5):362–376. pmid:35948014
- 2. Babu-Narayan SV, Diller GP, Gheta RR, Bastin AJ, Karonis T, Li W, et al. Clinical outcomes of surgical pulmonary valve replacement after repair of tetralogy of Fallot and potential prognostic value of preoperative cardiopulmonary exercise testing. Circulation. 2014;129(1):18–27. pmid:24146254
- 3. Ferraz Cavalcanti PE, Sá MP, Santos CA, Esmeraldo IM, de Escobar RR, de Menezes AM, et al. Pulmonary valve replacement after operative repair of tetralogy of Fallot: meta-analysis and meta-regression of 3,118 patients from 48 studies. J Am Coll Cardiol. 2013;62(23):2227–2243. pmid:24080109
- 4. Heng EL, Gatzoulis MA, Uebing A, Sethia B, Uemura H, Smith GC, et al. Immediate and Midterm Cardiac Remodeling After Surgical Pulmonary Valve Replacement in Adults With Repaired Tetralogy of Fallot: A Prospective Cardiovascular Magnetic Resonance and Clinical Study. Circulation. 2017;136(18):1703–1713. pmid:29084778
- 5. Alvarez-Fuente M, Garrido-Lestache E, Fernandez-Pineda L, Romera B, Sánchez I, Centella T, et al. Timing of Pulmonary Valve Replacement: How Much Can the Right Ventricle Dilate Before it Looses Its Remodeling Potential?. Pediatr Cardiol. 2016;37(3):601–605. pmid:26687177
- 6. Somerville J. Grown-up congenital heart disease—medical demands look back, look forward 2000. Thorac Cardiovasc Surg. 2001;49(1):21–26. pmid:11243517
- 7. Hribernik I, Thomson J, Ho A, English K, Van Doorn C, Jaber O, et al. Comparative analysis of surgical and percutaneous pulmonary valve implants over a 20-year period. Eur J Cardiothorac Surg. 2022;61(3):572–579. pmid:34406369
- 8. Zubairi R, Malik S, Jaquiss RD, Imamura M, Gossett J, Morrow WR. Risk factors for prosthesis failure in pulmonary valve replacement. Ann Thorac Surg. 2011;91(2):561–565. pmid:21256315
- 9. Chen XJ, Smith PB, Jaggers J, Lodge AJ. Bioprosthetic pulmonary valve replacement: contemporary analysis of a large, single-center series of 170 cases. J Thorac Cardiovasc Surg. 2013;146(6):1461–1466. pmid:23122698
- 10. Freling HG, van Slooten YJ, van Melle JP, Ebels T, Hoendermis ES, Berger RM, et al. Pulmonary valve replacement: twenty-six years of experience with mechanical valvar prostheses. Ann Thorac Surg. 2015;99(3):905–910. pmid:25617228
- 11. Chalard A, Sanchez I, Gouton M, Henaine R, Salami FA, Ninet J, et al. Effect of pulmonary valve replacement on left ventricular function in patients with tetralogy of Fallot. Am J Cardiol. 2012;110(12):1828–1835. pmid:22980967
- 12. Jang W, Kim YJ, Choi K, Lim HG, Kim WH, Lee JR. Mid-term results of bioprosthetic pulmonary valve replacement in pulmonary regurgitation after tetralogy of Fallot repair. Eur J Cardiothorac Surg. 2012;42(1):e1–e8. pmid:22561653
- 13. Lee C, Lee CH, Kwak JG. Outcomes of redo pulmonary valve replacement for bioprosthetic pulmonary valve failure in 61 patients with congenital heart disease. Eur J Cardiothorac Surg. 2016;50(3):470–475. pmid:26893380
- 14. Jain A, Oster M, Kilgo P, Grudziak J, Jokhadar M, Book W, et al. Risk factors associated with morbidity and mortality after pulmonary valve replacement in adult patients with previously corrected tetralogy of Fallot. Pediatr Cardiol. 2012;33(4):601–606. pmid:22322564
- 15. Lee C, Lee CH, Kwak JG. Polytetrafluoroethylene Bicuspid Pulmonary Valve Replacement: A 5-Year Experience in 119 Patients With Congenital Heart Disease. Ann Thorac Surg. 2016;102(1):163–169. pmid:27083247
- 16. Vliegen HW, van Straten A, de Roos A, Roest AA, Schoof PH, Zwinderman AH, et al. Magnetic resonance imaging to assess the hemodynamic effects of pulmonary valve replacement in adults late after repair of tetralogy of fallot. Circulation. 2002;106(13):1703–1707. pmid:12270866
- 17. Cleveland JD, Wells WJ. The Surgical Approach to Pulmonary Valve Replacement. Semin Thorac Cardiovasc Surg. 2022;34(4):1256–1261. pmid:35584775