150
[2]
[3]
[4]
[5]
Letters to the Editor abnormalities: prospective case–control study. Int J Cardiol Mar 1 2014;172(1): e116–8. Januzzi JL, Troughton R. Are serial BNP measurements useful in heart failure management? Serial natriuretic peptide measurements are useful in heart failure management. Circulation Jan 29 2013;127(4):500–7 [discussion 508, Review]. Crowson CS, Myasoedova E, Davis III JM, et al. Use of B-type natriuretic peptide as a screening tool for left ventricular diastolic dysfunction in rheumatoid arthritis patients without clinical cardiovascular disease. Arthritis Care Res (Hoboken) May 2011;63(5):729–34. Armstrong DJ, Gardiner PV, O'Kane MJ. Rheumatoid arthritis patients with active disease and no history of cardiac pathology have higher brain natriuretic peptide (BNP) levels than patients with inactive disease or healthy control subjects. Ulster Med J May 2010;79(2):82–4. Shiina Y, Funabashi N, Lee K, et al. Right atrium contractility and right ventricular diastolic function assessed by pulsed tissue Doppler imaging can predict brain
[6]
[7]
[8]
[9]
natriuretic peptide in adults with acquired pulmonary hypertension. Int J Cardiol Jun 12 2009;135(1):53–9. Vizzardi E, Cavazzana I, Bazzani C, et al. Echocardiographic evaluation of asymptomatic patients affected by rheumatoid arthritis. J Investig Med Dec 2012;60(8):1204–8. Birdane A, Korkmaz C, Ata N, et al. Tissue Doppler imaging in the evaluation of the left and right ventricular diastolic functions in rheumatoid arthritis. Echocardiography May 2007;24(5):485–93. Woods DR, Mellor A, Begley J, et al. Brain natriuretic peptide and NT-proBNP levels reflect pulmonary artery systolic pressure in trekkers at high altitude. Physiol Res Dec 20 2013;62(6):597–603. Keser G, Capar I, Aksu K, et al. Pulmonary hypertension in rheumatoid arthritis. Scand J Rheumatol 2004;33(4):244–5.
http://dx.doi.org/10.1016/j.ijcard.2014.03.157 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
Clinical profile of Brugada syndrome in Hong Kong Chinese population Christopher B. Wong ⁎, MBBS FACC Cardiology Specialty, Quality Healthcare Medical Service, Hong Kong
a r t i c l e
i n f o
Article history: Received 1 January 2014 Received in revised form 13 March 2014 Accepted 22 March 2014 Available online 29 March 2014 Keywords: Brugada syndrome Sudden cardiac death Electrophysiology studies Arrhythmia Syncope
There has been controversy concerning the optimal management of patients with Brugada ECG patterns. Brugada et al. [1,4] recommended that patients with aborted sudden cardiac death (SCD) be offered an implantable cardiac defibrillator (ICD) (Class 1 indication). Patients who have syncope thought to be related to arrhythmia and type I ECG pattern should receive an ICD (Class 2 indication). Patients with a family history of SCD related to Brugada syndrome and a positive electrophysiology (EP) study should also receive an ICD (Class IIb indication). A positive EP study and a history of syncope were the main predictors of future arrhythmic events. Priori et al. [2] however, did not confirm Brugada's findings. The event rates after diagnosis among asymptomatic patients in Priori's study were significantly lower [3]. We report a retrospective study of Hong Kong patients of Chinese descent with Brugada ECG who were followed for up to 22 years. A total of 68 consecutive patients (mean age 51.4, range 21 to 77, 93% male, from 1989 to 2011) were included in the study. 41% had type I Brugada ECG patterns. 38 patients were asymptomatic (Group A), 25 had syncope presumably arrhythmic in origin (Group B) and five suffered from SCD (Group C). A family history of SCD was not common in our cohort (10.3%). Four patients in Group C received ICD implants. The remaining patient refused ICD and was put on mexilitine for 16 years without any events. One patient in Group C had ventricular fibrillation storm a few months
⁎ Tower 1, 16th floor, Admiralty Center, Hong Kong. Tel.: +852 63135929. E-mail address: [email protected] (C.B. Wong).
after the ICD implant. In Group B, 11 patients underwent EP studies and 8 had positive results (73%). 16 patients underwent flecainide stimulation tests with 31% positive results. Eight patients with a positive EP study had ICD implant. One other patient had an ICD implant despite a negative EP study due to the concern of cardiac syncope related to type I Brugada syndrome. The remaining 16 patients had follow up for 5.5 +/ − 3.2 years (range 1 to 10 years) without any cardiac events. One 43 year old man with a type I Brugada ECG pattern and syncope refused to have an EP study. He was followed for 10 years without cardiac events. No patients had ICD shocks after ICD implantation. No patients had sustained arrhythmia despite positive EP studies. Only one patient with type I Brugada ECG pattern and a positive EP study demonstrated nonsustained ventricular tachycardia on follow up. In Group A, all patients remained asymptomatic during the follow up (mean of five years, range 1 to 14 years). Two patients received ICD implant after positive EP studies. No ICD shocks were recorded. EP studies were performed in six patients in Group A, with three positive studies (50%). One patient (age 23) (Group A) had abnormal EP study but refused ICD and was followed for 9 years without cardiac events. The positive predictive value of EP studies and flecainide stimulation test (Groups A and B) in predicting an arrhythmic event was less than 10% and 1% respectively. From the above findings, it is evident that our local population had a relatively benign course, especially asymptomatic patients or patients with syncope. The management algorithm proposed by Antzelevitch et al. (2005) [1,4] may not work for our population. From an epidemiological standpoint, the overall incidence of SCD (18: 100,000) in Hong Kong is much lower than the western counterpart. The underlying causes are acute myocardial infarction (31%), coronary/hypertensive heart disease (40%), cardiomyopathies (5%), and miscellaneous causes (23%). In less than 1%, channelopathies such as Brugada syndrome, Wolff Parkinson White syndrome and prolonged QT syndrome are the causes. Each year, fewer than 10 patients die of Brugada syndrome in Hong Kong. Over-diagnosing and over-treating the condition with suspicious ECG patterns should be avoided. The prevalence of asymptomatic Brugada ECG pattern was about 1% in Hong Kong Chinese population. Even with the best risk stratifying tool, the positive predictive value of the test in predicting SCD in asymptomatic patients with Brugada ECG pattern would be very low. Conversely, in Western society with an SCD incidence five to six times higher than that of Hong Kong, a risk
Letters to the Editor
stratifying test like electrophysiology testing or flecainide stimulation test may be of some value. In conclusion, Brugada syndrome is an uncommon condition responsible for SCD in Hong Kong. Patients who present with SCD associated with Brugada syndrome should be treated with an ICD, as recommended by the cardiology guidelines. However, with the current long term study results and an overall low incidence of SCD in Hong Kong, it is recommended that no further cardiac studies be performed on asymptomatic patients with Brugada ECG patterns since the positive predictive value of any risk stratifying test is extremely low (b10%). The management of patients with syncope is less clear. The current small cohort precludes us from drawing any definite conclusions. It appears that EP studies in this local population had very limited values in predicting future cardiac events. A possible explanation was that some patients suffered from neurocardiogenic syncope rather than arrhythmia related to Brugada syndrome. The generally benign course in our population certainly
151
calls for further studies to define a better management strategy. Although our findings may not be applicable to other populations, one should keep in mind that the guidelines laid by the cardiology authorities may not be applicable to populations with a low prevalence of SCD.
References [1] Antzelevitch C, Brugada P, Borggrefe M, et al. Brugada syndrome: report of the second consensus conference: endorsed by Heart Rhythm society and European Heart Rhythm Association. Circulation 2005;111:659. [2] Priori SG, Napolitano C, Gasparini M, et al. Natural history of Brugada syndrome: insights for risk stratification and management. Circulation 2002;105:1342–7. [3] Brugada J, Brugada R, Antzelevitch C, et al. Long term followup of individuals with electrocardiographic pattern of right bundle branch block and ST segment elevation in precordial leads V1 to V3. Circulation 2002;105:73–8. [4] Wilde AA, Antzelevitch C, Borggrefe M, et al. Proposed diagnostic criteria for Brugada syndrome. Eur Heart J 2002;23:1648.
http://dx.doi.org/10.1016/j.ijcard.2014.03.155 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
NOBORI™ biodegradable-polymer biolimus-eluting stent versus durable-polymer drug-eluting stents: A meta-analysis Yao-Jun Zhang a,b,1, Fei Ye a,1, Javaid Iqbal b, Sheng-Jie Dong c, Christos V. Bourantas b, Nai-Liang Tian a, Patrick W. Serruys b, Shao-Liang Chen a,⁎ a b c
Nanjing First Hospital, Nanjing Medical University, Nanjing, China Erasmus Medical Center, Rotterdam, The Netherlands Soochow University, Suzhou, China
a r t i c l e
i n f o
Article history: Received 3 January 2014 Received in revised form 11 March 2014 Accepted 23 March 2014 Available online 29 March 2014 Keywords: NOBORI Biodegradable-polymer Meta-analysis Stent thrombosis Myocardial infarction
Stent thrombosis (ST) is a potentially fatal complication of percutaneous coronary intervention. First-generation drug-eluting stents (DESs) have been linked with increased risk of late and very late ST, possibly secondary to inflammatory response induced by durable polymers [1]. Second-generation DESs with biocompatible polymers have shown a reduction in ST [2]. NOBORI™, a ‘third-generation’ DES with biodegradable-polymer and biolimus as anti-proliferative drug has been widely accepted in Asia and Europe since favorable results in NOBORI-1 trial in 2007 [3]. However, the four ‘all-comers’ trials have shown conflicting results [4–7]. The COMPARE-II (Comparison of the Everolimus Eluting with the Biolimus A9 Eluting Stent) and NEXT (NOBORI Biolimus-Eluting versus XIENCE/PROMUS Everolimus-Eluting ⁎ Corresponding author at: Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, No. 68 Changle Road, Nanjing City, Jiangsu Province, China. Tel./ fax: +86 25 52208048. E-mail address: [email protected] (S.-L. Chen). 1 Zhang Y.J. and Ye F. equally contributed to this article.
Stent Trial) trials have reported that NOBORI™ is non-inferior to XIENCEV/PROMUS (a durable polymer everolimus-eluting second-generation DES) [4,6]. Conversely, the SORT-OUT (Scandinavian Organization for Randomized Trials with Clinical Outcome) V trial has reported that NOBORI™ stent is inferior to Cypher™ (a durable polymer sirolimuseluting first-generation DES) in terms of the 9-month composite primary endpoint, a composite of safety (cardiac death, myocardial infarction [MI], definite ST) and efficacy (target vessel revascularization) [5]. Considering the conflicting evidence from recent trials, we performed a meta-analysis of all NOBORI™ stent trials to investigate its safety performance. The methods are presented in the online supplementary materials. The endpoints in this meta-analysis included: 1) Definite/probable ST, defined by Academic Research Consortium classification, 2) MI, including non-Q-wave and Q-wave MI, and 3) Mortality. NOBORI™ stent has been tested in 7 trials so far. Pooled relative risks (RRs) were calculated using a fixed effect model with Mantel–Haenszel method [8]. The characteristics of included trials are shown in Supplement Table 1. Our meta-analysis has shown that the incidence of definite/ probable ST at 1-year was 0.53% (35/6574) in the NOBORI™ biodegradable polymer DES and 0.51% (28/5533) in the comparator durable polymer DES. The RR for definite/probable ST associated with NOBORI™ stent versus durable polymer DES was 0.96 (95% confidence interval [CI]: 0.59–1.57, p = 0.88) in 7 trials, and 0.82 (95% CI: 0.46–1.47, p = 0.51) in the ‘versus second generation’ subgroup (Fig. 1A), indicating a similar incidence of definite/ probable ST with NOBORI™ stent, even compared with second generation DES. The pooled RR for myocardial infarction associated with the NOBORI™ stent versus durable polymer DES was 1.11 (95% CI 0.88–1.39, p = 0.39, Fig. 1B), and there was no significant
[2]
[3]
[4]
[5]
Letters to the Editor abnormalities: prospective case–control study. Int J Cardiol Mar 1 2014;172(1): e116–8. Januzzi JL, Troughton R. Are serial BNP measurements useful in heart failure management? Serial natriuretic peptide measurements are useful in heart failure management. Circulation Jan 29 2013;127(4):500–7 [discussion 508, Review]. Crowson CS, Myasoedova E, Davis III JM, et al. Use of B-type natriuretic peptide as a screening tool for left ventricular diastolic dysfunction in rheumatoid arthritis patients without clinical cardiovascular disease. Arthritis Care Res (Hoboken) May 2011;63(5):729–34. Armstrong DJ, Gardiner PV, O'Kane MJ. Rheumatoid arthritis patients with active disease and no history of cardiac pathology have higher brain natriuretic peptide (BNP) levels than patients with inactive disease or healthy control subjects. Ulster Med J May 2010;79(2):82–4. Shiina Y, Funabashi N, Lee K, et al. Right atrium contractility and right ventricular diastolic function assessed by pulsed tissue Doppler imaging can predict brain
[6]
[7]
[8]
[9]
natriuretic peptide in adults with acquired pulmonary hypertension. Int J Cardiol Jun 12 2009;135(1):53–9. Vizzardi E, Cavazzana I, Bazzani C, et al. Echocardiographic evaluation of asymptomatic patients affected by rheumatoid arthritis. J Investig Med Dec 2012;60(8):1204–8. Birdane A, Korkmaz C, Ata N, et al. Tissue Doppler imaging in the evaluation of the left and right ventricular diastolic functions in rheumatoid arthritis. Echocardiography May 2007;24(5):485–93. Woods DR, Mellor A, Begley J, et al. Brain natriuretic peptide and NT-proBNP levels reflect pulmonary artery systolic pressure in trekkers at high altitude. Physiol Res Dec 20 2013;62(6):597–603. Keser G, Capar I, Aksu K, et al. Pulmonary hypertension in rheumatoid arthritis. Scand J Rheumatol 2004;33(4):244–5.
http://dx.doi.org/10.1016/j.ijcard.2014.03.157 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
Clinical profile of Brugada syndrome in Hong Kong Chinese population Christopher B. Wong ⁎, MBBS FACC Cardiology Specialty, Quality Healthcare Medical Service, Hong Kong
a r t i c l e
i n f o
Article history: Received 1 January 2014 Received in revised form 13 March 2014 Accepted 22 March 2014 Available online 29 March 2014 Keywords: Brugada syndrome Sudden cardiac death Electrophysiology studies Arrhythmia Syncope
There has been controversy concerning the optimal management of patients with Brugada ECG patterns. Brugada et al. [1,4] recommended that patients with aborted sudden cardiac death (SCD) be offered an implantable cardiac defibrillator (ICD) (Class 1 indication). Patients who have syncope thought to be related to arrhythmia and type I ECG pattern should receive an ICD (Class 2 indication). Patients with a family history of SCD related to Brugada syndrome and a positive electrophysiology (EP) study should also receive an ICD (Class IIb indication). A positive EP study and a history of syncope were the main predictors of future arrhythmic events. Priori et al. [2] however, did not confirm Brugada's findings. The event rates after diagnosis among asymptomatic patients in Priori's study were significantly lower [3]. We report a retrospective study of Hong Kong patients of Chinese descent with Brugada ECG who were followed for up to 22 years. A total of 68 consecutive patients (mean age 51.4, range 21 to 77, 93% male, from 1989 to 2011) were included in the study. 41% had type I Brugada ECG patterns. 38 patients were asymptomatic (Group A), 25 had syncope presumably arrhythmic in origin (Group B) and five suffered from SCD (Group C). A family history of SCD was not common in our cohort (10.3%). Four patients in Group C received ICD implants. The remaining patient refused ICD and was put on mexilitine for 16 years without any events. One patient in Group C had ventricular fibrillation storm a few months
⁎ Tower 1, 16th floor, Admiralty Center, Hong Kong. Tel.: +852 63135929. E-mail address: [email protected] (C.B. Wong).
after the ICD implant. In Group B, 11 patients underwent EP studies and 8 had positive results (73%). 16 patients underwent flecainide stimulation tests with 31% positive results. Eight patients with a positive EP study had ICD implant. One other patient had an ICD implant despite a negative EP study due to the concern of cardiac syncope related to type I Brugada syndrome. The remaining 16 patients had follow up for 5.5 +/ − 3.2 years (range 1 to 10 years) without any cardiac events. One 43 year old man with a type I Brugada ECG pattern and syncope refused to have an EP study. He was followed for 10 years without cardiac events. No patients had ICD shocks after ICD implantation. No patients had sustained arrhythmia despite positive EP studies. Only one patient with type I Brugada ECG pattern and a positive EP study demonstrated nonsustained ventricular tachycardia on follow up. In Group A, all patients remained asymptomatic during the follow up (mean of five years, range 1 to 14 years). Two patients received ICD implant after positive EP studies. No ICD shocks were recorded. EP studies were performed in six patients in Group A, with three positive studies (50%). One patient (age 23) (Group A) had abnormal EP study but refused ICD and was followed for 9 years without cardiac events. The positive predictive value of EP studies and flecainide stimulation test (Groups A and B) in predicting an arrhythmic event was less than 10% and 1% respectively. From the above findings, it is evident that our local population had a relatively benign course, especially asymptomatic patients or patients with syncope. The management algorithm proposed by Antzelevitch et al. (2005) [1,4] may not work for our population. From an epidemiological standpoint, the overall incidence of SCD (18: 100,000) in Hong Kong is much lower than the western counterpart. The underlying causes are acute myocardial infarction (31%), coronary/hypertensive heart disease (40%), cardiomyopathies (5%), and miscellaneous causes (23%). In less than 1%, channelopathies such as Brugada syndrome, Wolff Parkinson White syndrome and prolonged QT syndrome are the causes. Each year, fewer than 10 patients die of Brugada syndrome in Hong Kong. Over-diagnosing and over-treating the condition with suspicious ECG patterns should be avoided. The prevalence of asymptomatic Brugada ECG pattern was about 1% in Hong Kong Chinese population. Even with the best risk stratifying tool, the positive predictive value of the test in predicting SCD in asymptomatic patients with Brugada ECG pattern would be very low. Conversely, in Western society with an SCD incidence five to six times higher than that of Hong Kong, a risk
Letters to the Editor
stratifying test like electrophysiology testing or flecainide stimulation test may be of some value. In conclusion, Brugada syndrome is an uncommon condition responsible for SCD in Hong Kong. Patients who present with SCD associated with Brugada syndrome should be treated with an ICD, as recommended by the cardiology guidelines. However, with the current long term study results and an overall low incidence of SCD in Hong Kong, it is recommended that no further cardiac studies be performed on asymptomatic patients with Brugada ECG patterns since the positive predictive value of any risk stratifying test is extremely low (b10%). The management of patients with syncope is less clear. The current small cohort precludes us from drawing any definite conclusions. It appears that EP studies in this local population had very limited values in predicting future cardiac events. A possible explanation was that some patients suffered from neurocardiogenic syncope rather than arrhythmia related to Brugada syndrome. The generally benign course in our population certainly
151
calls for further studies to define a better management strategy. Although our findings may not be applicable to other populations, one should keep in mind that the guidelines laid by the cardiology authorities may not be applicable to populations with a low prevalence of SCD.
References [1] Antzelevitch C, Brugada P, Borggrefe M, et al. Brugada syndrome: report of the second consensus conference: endorsed by Heart Rhythm society and European Heart Rhythm Association. Circulation 2005;111:659. [2] Priori SG, Napolitano C, Gasparini M, et al. Natural history of Brugada syndrome: insights for risk stratification and management. Circulation 2002;105:1342–7. [3] Brugada J, Brugada R, Antzelevitch C, et al. Long term followup of individuals with electrocardiographic pattern of right bundle branch block and ST segment elevation in precordial leads V1 to V3. Circulation 2002;105:73–8. [4] Wilde AA, Antzelevitch C, Borggrefe M, et al. Proposed diagnostic criteria for Brugada syndrome. Eur Heart J 2002;23:1648.
http://dx.doi.org/10.1016/j.ijcard.2014.03.155 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
NOBORI™ biodegradable-polymer biolimus-eluting stent versus durable-polymer drug-eluting stents: A meta-analysis Yao-Jun Zhang a,b,1, Fei Ye a,1, Javaid Iqbal b, Sheng-Jie Dong c, Christos V. Bourantas b, Nai-Liang Tian a, Patrick W. Serruys b, Shao-Liang Chen a,⁎ a b c
Nanjing First Hospital, Nanjing Medical University, Nanjing, China Erasmus Medical Center, Rotterdam, The Netherlands Soochow University, Suzhou, China
a r t i c l e
i n f o
Article history: Received 3 January 2014 Received in revised form 11 March 2014 Accepted 23 March 2014 Available online 29 March 2014 Keywords: NOBORI Biodegradable-polymer Meta-analysis Stent thrombosis Myocardial infarction
Stent thrombosis (ST) is a potentially fatal complication of percutaneous coronary intervention. First-generation drug-eluting stents (DESs) have been linked with increased risk of late and very late ST, possibly secondary to inflammatory response induced by durable polymers [1]. Second-generation DESs with biocompatible polymers have shown a reduction in ST [2]. NOBORI™, a ‘third-generation’ DES with biodegradable-polymer and biolimus as anti-proliferative drug has been widely accepted in Asia and Europe since favorable results in NOBORI-1 trial in 2007 [3]. However, the four ‘all-comers’ trials have shown conflicting results [4–7]. The COMPARE-II (Comparison of the Everolimus Eluting with the Biolimus A9 Eluting Stent) and NEXT (NOBORI Biolimus-Eluting versus XIENCE/PROMUS Everolimus-Eluting ⁎ Corresponding author at: Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, No. 68 Changle Road, Nanjing City, Jiangsu Province, China. Tel./ fax: +86 25 52208048. E-mail address: [email protected] (S.-L. Chen). 1 Zhang Y.J. and Ye F. equally contributed to this article.
Stent Trial) trials have reported that NOBORI™ is non-inferior to XIENCEV/PROMUS (a durable polymer everolimus-eluting second-generation DES) [4,6]. Conversely, the SORT-OUT (Scandinavian Organization for Randomized Trials with Clinical Outcome) V trial has reported that NOBORI™ stent is inferior to Cypher™ (a durable polymer sirolimuseluting first-generation DES) in terms of the 9-month composite primary endpoint, a composite of safety (cardiac death, myocardial infarction [MI], definite ST) and efficacy (target vessel revascularization) [5]. Considering the conflicting evidence from recent trials, we performed a meta-analysis of all NOBORI™ stent trials to investigate its safety performance. The methods are presented in the online supplementary materials. The endpoints in this meta-analysis included: 1) Definite/probable ST, defined by Academic Research Consortium classification, 2) MI, including non-Q-wave and Q-wave MI, and 3) Mortality. NOBORI™ stent has been tested in 7 trials so far. Pooled relative risks (RRs) were calculated using a fixed effect model with Mantel–Haenszel method [8]. The characteristics of included trials are shown in Supplement Table 1. Our meta-analysis has shown that the incidence of definite/ probable ST at 1-year was 0.53% (35/6574) in the NOBORI™ biodegradable polymer DES and 0.51% (28/5533) in the comparator durable polymer DES. The RR for definite/probable ST associated with NOBORI™ stent versus durable polymer DES was 0.96 (95% confidence interval [CI]: 0.59–1.57, p = 0.88) in 7 trials, and 0.82 (95% CI: 0.46–1.47, p = 0.51) in the ‘versus second generation’ subgroup (Fig. 1A), indicating a similar incidence of definite/ probable ST with NOBORI™ stent, even compared with second generation DES. The pooled RR for myocardial infarction associated with the NOBORI™ stent versus durable polymer DES was 1.11 (95% CI 0.88–1.39, p = 0.39, Fig. 1B), and there was no significant
