Cardiac resynchronization therapy system implantation complications

Имплантацията на система за сърдечна ресинхронизираща терапия (CРТ) чрез електрод за стимулация на лявата камера през клон на коронарен синус (КС) е утвърден метод на лечение при пациенти с конгестивна сърдечна недостатъчност и асинхронна камерна контракция. Успешната терапия зависи от имплантацията на левокамерен електрод, обикновено в латерален или постеролатерален клон на КС, което технически се оказва по-предизвикателна и тежка процедура в сравнение с имплантацията на еднокухинна или двукухинна система за кардиостимулация. Без опит и подготовка на оператора тази процедура може да се превърне в доста продължителен кошмар и дори да завърши без успех или още по-лошо – с усложнение. По тази причина методите за имплантация на ЛК електрод с фокус върху усложненията при този вид процедура са разгледани в настоящия обзор, базирайки се на световната литература в тази област и на собствения ни опит, който имаме с повече от 4500 процедури за периода 2002-2021 г. Cardiac resynchronization therapy (CRT) using coronary sinus (CS) leads is an established method for the therapy of congestive heart failure (CHF) in the case of asynchronous ventricular contractions. Successful therapy depends on the placement of left ventricular leads usually via the coronary sinus (CS), a technically more challenging procedure than regular pacemaker implantations. Without specifi c precautions CRT implantation can be the gateway to a time-consuming nightmare. Therefore, CS lead implantation methods, with a focus on complications, were reviewed according to the literature and our own experience with approximately 4500 procedures from 2002-2021

Cardiac implantable electronic devices in Bulgaria: results from the electronic registry BG-Pace for the period 2019-2021

Настоящата разработка представя анализ на дейността по електрокардиостимулация в България през 2019, 2020 и 2021 година на базата на данни от национален регистър на имплантираните пациенти. Материали и методи. Данните, въведени в регистъра BG-Pace за периода м .08-2019 – м. 06.2021 са изследвани ретроспективно. Анализирани са демографски данни на пациентите, типа процедура, типа устройство, режима на стимулация, етиологията, симптомите и ЕКГ образа преди имплантацията. Направен е и анализ на броя имплантации при различните типове устройства и обема дейност на центрове и оператори. Резултати. За изследвания период са имплантирани 6949 устройства от 47 оператори в 28 центъра. Възрастта на пациентите при имплантацията е била 75 (IQR 68-81, 21-103) години за мъжете и 77 (IQR 71-82, 17-98) години за жените, Р ‹ 0,05. Най-голям брой имплантации са осъществени във възрастовата група 70-79 години. Основен дял заемат антибрадикардните стимулатори, от които за периода м.08.2019-м.08.2020 г. са имплантирани общо 486,7/милион, а за периода м. 08.2020-м. 06.2021 г. този брой е 353,9/милион. Броят на имплантираните кардиовертер-дефибрилатори нараства за периода 08.2020-06.2021 г. спрямо предходния период – от 14,1 на 20,1/милион, а броят имплантирани устройства от всички типове спада по време на двете епидемични вълни от КОВИД-19. Средният брой имплантации за център за целия период е 232,3 ± 204 (2-705), а за оператор – 148±139,1 (2-660) устройства. Преобладават имплантациите на двукухинни устройства, чийто дял е 65,8% при АV блок І и ІІ степен, 63,5% при пълен АV блок, 59,8% при нарушения на вътрекамерната проводимост и 60,9% при синдрома на болния синусов възел. Режимите, позволяващи предсърден сензинг демонстрират превъзходство – над 55% при всички проводни нарушения. Налице е значимо (Р ‹ 0,001) нарастване на дяла на VVІ режима с нарастване на възрастта. Заключение. Националният регистър BG-Pace включва системно въведени клинични, демографски и процедурни данни на имплантираните пациенти. Демонстрира се нисък брой имплантации в сравнение със средното европейско ниво като се забелязва значим спад по време на двете вълни на пандемията от КОВИД-19.  The current study analyses the activity in cardiac pacing in Bulgaria in 2019, 2020 and 2021 based on data derived from a national registry of patients with cardiac electronic implantable devices (CIEDs). Materials and methods. Data from the national registry BG-Pace in the period 08.2019-06.2021 was retrospectively studied. Demographic data, procedure and device type, pacing mode, etiology, symptoms, preimplantation ECG, number of implantations and centre and operator volumes were analysed. Results. Six thousand nine hundred forty-nine devices were implanted by 47 operators in 28 centres for the study period. Median age was 75 (IQR 68-81, 21-103) years in males and 77 (IQR 71-82, 17-98) years in females, P ‹ 0.05. The largest number of devices were implanted in the age group 70-79 years. The most commonly implanted CIEDs were antibradycardia devices with a total of 486.7/million implantations for the period 08.2019-08.2020 and 353.9/million for the period 08.2020-06.2021. Implanted cardioverter-defibrillators demonstrated a growth from 14.1/million to 20.1/million in the period 08.2020 – 06.2021. The number of all implantations dropped signifi cantly during the two epidemic waves of COVID-19. The mean number of implantations per centre and per operator for the whole period was 232.3±204 (2-705) and 148±139.1 (2-660), respectively. Dual chamber device implantations were more prevalent, representing 65.8% of implantations in AV block I and II degree, 63.5% in complete AV block, 59.8% in intraventricular conduction disturbances and 60.9% in sick sinus syndrome. Pacing modes with atrial sensing represented more than 55% of the implantations for all indications. Increasing age was associated with signifi cantly more common use of VVI pacing mode (P ‹ 0.001). Conclusion. The national registry BG-Pace includes systematic clinical, demographical and procedural data for CIED implantations in Bulgaria. Results demonstrate lower number of implantations compared to the average European volume. There was a signifi cant drop in the implantation rate during the two waves of COVID-19.

Cardiac implantable electronic devices in Bulgaria: results from the electronic registry BG-Pace for 2022

Настоящото проучване представя анализ на дейността по електрокардиостимулация в България през 2022 година на базата на данни от национален регистър на имплантираните пациенти. Материали и методи:              Данните, въведени в регистъра BG-Pace за 2022 година са изследвани ретроспективно. Анализирани са демографски данни на пациентите, типа процедура, типа устройство, режима на стимулация, етиологията, симптомите и ЕКГ образа преди имплантацията. Анализиран е броят имплантации при различните типове устройства и обема дейност на центрове и оператори.               Резултати: За изследвания период са имплантирани 4770 устройства от 45 оператори в 30 центъра. Възрастта на пациентите при имплантацията е била 76 (IQR 69-82, 14-98) години като преобладават пациентите от мъжки пол – 2843 (59,6%). Най-голям брой имплантации са осъществени във възрастовата група 70-79 години. Основен дял заемат антибрадикардните стимулатори - 578,8/милион. От тях системи за физиологична стимулация са били 111 (2,3%). Броят на имплантираните кардиовертер-дефибрилатори е по-висок спрямо предходни периоди и достига 31,9/милион. Имплантациите на системи за ресинхронизираща терапия с функция на дефибрилатор също бележат ръст до 15,9/милион. Значителен ръст се наблюдава и при имплантируемите лууп-рекордери, които достигат до 8,8/милион. Броят имплантации за център е  бил 115,5 (IQR 53-261,3, 3-546), а за оператор – 76,5 (IQR 36,8-154,8, 3-364) устройства. Преобладават имплантациите на двукухинни устройства, чийто дял е 83,1% при АV блок І и ІІ степен, 72,5% при пълен АV блок, 82,6% при нарушения на вътрекамерната проводимост и 66,8% при синдрома на болния синусов възел. Режимите, позволяващи предсърден сензинг демонстрират превъзходство  – 62,4% при всички проводни нарушения. Налице е значимо (Р<0,001) нарастване на дяла на VVІ режима с нарастване на възрастта. Заключение: Националният регистър BG-Pace включва системно въведени клинични, демографски и процедурни данни на имплантираните пациенти. Демонстрира се повишаване на броя на  имплантации в сравнение с предходни периоди като същият остава нисък спрямо средното европейско ниво. The current study analyses the activity on cardiac pacing in Bulgaria in 2022 based on data derived from a national registry of patients with cardiac implantable electronic devices (CIEDs). Materials and methods. Data from the national registry BG-Pace for 2022 was studied retrospectively. Demographic data, procedure and device type, pacing mode, etiology, symptoms, preimplantation ECG, number of implantations, and centre and operator volumes were analyzed. Results: Four thousand seven hundred seventy devices were implanted by 45 operators in 30 centers. Median age was 76 (IQR 69-82, 14-98) years, and male patients were 2843 (59,6%). The most significant number of implantations were carried out in the age group 70-79 years. The most commonly implanted CIEDs were antibradycardia devices - 578,8/million. Of them, conduction system pacing was used in 111 (2.3%). Implanted cardioverter-defibrillators demonstrated a growth compared to previous periods and reached 31.9/million. Cardiac resynchronization defibrillators implantations also shown a growth to 15.9/million. A considerable increase was found with implantable loop-recorders, which reached 8.8/million. Number of implantations per center was 115.5 (IQR 53-261.,3, 3-546), and 76,5 (IQR 36,8-154,8, 3-364) devices per operator. Dual chamber devices were most commonly implanted with a share of 83.1% in AVB I and II degrees, 72.5% in complete AVB, 82.6% in intraventricular conduction disturbances, and in 66.8% in patients with sick sinus syndrome. Pacing modes allowing for atrial sensing were most frequently implanted – 62.4% of all implantations for conduction disturbances. There was a significant increase in the use of VVI mode with increasing age (P<0.001). Conclusion: The national registry BG-Pace includes systematic clinical, demographical, and procedural data for CIED implantations in Bulgaria. There is a growth in the implantation rates compared to previous periods, but they remain lower than the average number for Europe

Cardiac resynchronization therapy pacemaker or cardiac resynchronization therapy defibrillator: what determines the choice?-findings from the ESC CRT Survey II

AIMS The decision to implant a cardiac resynchronization therapy pacemaker (CRT-P) or a cardiac resynchronization therapy defibrillator (CRT-D) may be challenging. There are no clear guideline recommendations as no randomized study of cardiac resynchronization therapy (CRT) has been designed to compare the effects of CRT-P with those of CRT-D on patients' outcomes. In the CRT Survey II, we studied patient and implantation centre characteristics associated with the choice of CRT-P vs. CRT-D. METHODS AND RESULTS Clinical practice data from 10 692 patients undergoing CRT implantation of whom 7467 (70%) patients received a CRT-D and 3225 (30%) received a CRT-P across 42 ESC countries were collected and analysed between October 2015 and January 2017. Factors favouring the selection of CRT-P implantation included age >75 years, female gender, non-ischaemic heart failure (HF) aetiology, New York Heart Association functional Class III/IV symptoms, left ventricular ejection fraction >25%, atrial fibrillation, atrioventricular (AV) block II/III, and implantation in a university hospital. CONCLUSION In a large cohort from the CRT Survey II, we found that patients allocated to receive CRT-P exhibited particular phenotypes with more symptomatic HF, more frequent comorbidities, advanced age, female gender, non-ischaemic HF aetiology, atrial fibrillation, and evidence of AV block. There were substantial differences in the proportion of patients allocated to receive CRT-P vs. CRT-D between countries

Present criteria for prophylactic ICD implantation: Insights from the EU-CERT-ICD (Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in EUrope) project

BACKGROUND. The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. It is urgently needed to better identify patients who benefit from prophylactic ICD therapy. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) completed in 2019 will assess this issue. SUMMARY. The EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicenter observational cohort study done in 44 centers across 15 European countries. A total of 2327 patients with heart failure due to ischemic heart disease or dilated cardiomyopathy indicated for primary prophylactic ICD implantation were recruited between 2014 and 2018 (>1500 patients at first ICD implantation, >750 patients non-randomized non-ICD control group). The primary endpoint was all-cause mortality, first appropriate shock was co-primary endpoint. At baseline, all patients underwent 12-lead ECG and Holter-ECG analysis using multiple advanced methods for risk stratification as well as documentation of clinical characteristics and laboratory values. The EU-CERT-ICD data will provide much needed information on the survival benefit of preventive ICD therapy and expand on previous prospective risk stratification studies which showed very good applicability of clinical parameters and advanced risk stratifiers in order to define patient subgroups with above or below average ICD benefit. CONCLUSION. The EU-CERT-ICD study will provide new and current data about effectiveness of primary prophylactic ICD implantation. The study also aims for improved risk stratification and patient selection using clinical risk markers in general, and advanced ECG risk markers in particular.peerReviewe

Present criteria for prophylactic ICD implantation:insights from the EU-CERT-ICD (Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in EUrope) project

Abstract Background: The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. It is urgently needed to better identify patients who benefit from prophylactic ICD therapy. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) completed in 2019 will assess this issue. Summary: The EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicenter observational cohort study done in 44 centers across 15 European countries. A total of 2327 patients with heart failure due to ischemic heart disease or dilated cardiomyopathy indicated for primary prophylactic ICD implantation were recruited between 2014 and 2018 (&gt;1500 patients at first ICD implantation, &gt;750 patients non-randomized non-ICD control group). The primary endpoint was all-cause mortality, and first appropriate shock was co-primary endpoint. At baseline, all patients underwent 12‑lead ECG and Holter-ECG analysis using multiple advanced methods for risk stratification as well as documentation of clinical characteristics and laboratory values. The EU-CERT-ICD data will provide much needed information on the survival benefit of preventive ICD therapy and expand on previous prospective risk stratification studies which showed very good applicability of clinical parameters and advanced risk stratifiers in order to define patient subgroups with above or below average ICD benefit. Conclusion: The EU-CERT-ICD study will provide new and current data about effectiveness of primary prophylactic ICD implantation. The study also aims for improved risk stratification and patient selection using clinical risk markers in general, and advanced ECG risk markers in particular

Rationale and design of the EU-CERT-ICD prospective study: comparative effectiveness of prophylactic ICD implantation

AIMS: The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) aims to assess its current clinical value. METHODS AND RESULTS: The EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicentre observational cohort study performed in 44 centres across 15 European Union countries. We will recruit 2250 patients with ischaemic or dilated cardiomyopathy and a guideline indication for primary prophylactic ICD implantation. This sample will include 1500 patients at their first ICD implantation and 750 patients who did not receive a primary prevention ICD despite having an indication for it (non-randomized control group). The primary endpoint is all-cause mortality; the co-primary endpoint in ICD patients is time to first appropriate shock. Secondary endpoints include sudden cardiac death, first inappropriate shock, any ICD shock, arrhythmogenic syncope, revision procedures, quality of life, and cost-effectiveness. At baseline (and prior to ICD implantation if applicable), all patients undergo 12-lead electrocardiogram (ECG) and Holter ECG analysis using multiple advanced methods for risk stratification as well as detailed documentation of clinical characteristics and laboratory values. Genetic biobanking is also organized. As of August 2018, baseline data of 2265 patients are complete. All subjects will be followed for up to 4.5 years. CONCLUSIONS: The EU-CERT-ICD study will provide a necessary update about clinical effectiveness of primary prophylactic ICD implantation. This study also aims for improved risk stratification and patient selection using clinical and ECG risk markers.peerReviewe

Clinical effectiveness of primary prevention implantable cardioverter-defibrillators: results of the EU-CERT-ICD controlled multicentre cohort study

Aims: The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter-Defibrillators (EU-CERT-ICD), a prospective investigator-initiated, controlled cohort study, was conducted in 44 centres and 15 European countries. It aimed to assess current clinical effectiveness of primary prevention ICD therapy. Methods and results: We recruited 2327 patients with ischaemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM) and guideline indications for prophylactic ICD implantation. Primary endpoint was all-cause mortality. Clinical characteristics, medications, resting, and 12-lead Holter electrocardiograms (ECGs) were documented at enrolment baseline. Baseline and follow-up (FU) data from 2247 patients were analysable, 1516 patients before first ICD implantation (ICD group) and 731 patients without ICD serving as controls. Multivariable models and propensity scoring for adjustment were used to compare the two groups for mortality. During mean FU of 2.4 ± 1.1 years, 342 deaths occurred (6.3%/years annualized mortality, 5.6%/years in the ICD group vs. 9.2%/years in controls), favouring ICD treatment [unadjusted hazard ratio (HR) 0.682, 95% confidence interval (CI) 0.537–0.865, P = 0.0016]. Multivariable mortality predictors included age, left ventricular ejection fraction (LVEF), New York Heart Association class <III, and chronic obstructive pulmonary disease. Adjusted mortality associated with ICD vs. control was 27% lower (HR 0.731, 95% CI 0.569–0.938, P = 0.0140). Subgroup analyses indicated no ICD benefit in diabetics (adjusted HR = 0.945, P = 0.7797, P for interaction = 0.0887) or those aged ≥75 years (adjusted HR 1.063, P = 0.8206, P for interaction = 0.0902). Conclusion: In contemporary ICM/DCM patients (LVEF ≤35%, narrow QRS), primary prophylactic ICD treatment was associated with a 27% lower mortality after adjustment. There appear to be patients with less survival advantage, such as older patients or diabetics.peerReviewe