Adherence to ESC cardiac resynchronization therapy guidelines: findings from the ESC CRT Survey II.

AIMS: Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in patients with heart failure (HF) and electrical dyssynchrony. The European Society of Cardiology (ESC) Guidelines provide evidence-based recommendations indicating optimal patient selection for CRT implantation in both the 2013 European Heart Rhythm Association (EHRA) and the 2016 Heart Failure Association (HFA) Guidelines. We assessed the adherence to guidelines and identified factors associated with guideline adherence. METHODS AND RESULTS: In 2016, the HFA and EHRA conducted the CRT Survey II in 42 ESC countries. The data collected were sufficient to evaluate adherence to guidelines in 8021 patients. Of these, 67% had a Class I guideline indication for CRT implantation, which was significantly correlated with female gender (1.70, P < 0.0001), age <75 years (1.55, P < 0.0001), non-ischaemic HF aetiology (1.22, P < 0.0001), and elective admission (1.87, P < 0.0001). A further 26% of implants had a Class IIa indication, 5% IIb and only 2% a contraindication to CRT-a Class III indication. Patients implanted under Level IIa indications were much more likely to have more comorbidities than patients implanted under Level I indications. However, there were large variations in guideline adherence between ESC countries. CONCLUSION: Implanters in ESC member states demonstrate a high degree of adherence to ESC guidelines with 98% of implants having a documented Class I, IIa or IIb indication. Cardiac resynchronization therapy implantation without a Class I indication was more likely in men, patients age ≥75 years, with HF of ischaemic origin and in patients admitted to hospital acutely.

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, and first appropriate shock was co-primary endpoint. At baseline, all patients underwent 12­lead 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.

Failed carotid artery stenting followed by successful surgical intervention: Case report.

A 56-year-old female patient with significant carotid stenoses with circumferential plaques, causing localized vascular narrowing, was inappropriately indicated for carotid artery stenting. After placement of a distal embolic protection device in the left internal carotid artery, a stent was inserted; however, it could not be fully deployed due to the rigid, severely calcified vascular walls. The various endovascular attempts to recapture the protection device were futile and, eventually, led to fracture of the guidewire of the device and it remained entrapped together with the stent. Emergency carotid arteriotomy with extirpation of the stent and embolic protection device via carotid thromboendarterectomy was performed. In conclusion, the proper patient selection for carotid artery stenting is of utmost importance.

Implantation of a Cardiac resynchronization therapy system in a patient with an unroofed coronary sinus.

The unroofed coronary sinus (URCS) is a spectrum of cardiac anomalies in which part or all of the common wall between the coronary sinus and the left atrium is absent. Rarely, it is associated with coronary sinus atresia. The diagnosis of this lesion is important for the prognosis of the patient, especially in cases when cardiac interventions such as CRT implantation needs to be performed. It is found incidentally because of nonspecific clinical features. We report a case of a complete URCS and CS atresia during a computed tomographic investigation performed following prior impossibility of LV lead to be implanted.

LV pacing as an alternative option to conventional RV pacing in a patient with tricuspid valve replacement.

Tricuspid regurgitation (TR) is a relatively common anomaly. In patients with tricuspid valve repair/replacement (TVR)the control of atrioventricular conduction irregularity can be demanding, given the unavailability for implantation of the right ventricular (RV) endocardial lead, which is not recommended in such cases because of the risk of lead fracture at the valve site and valve damage or failure. Thus, epicardial lead may be an option; it requires a surgical procedure and it is not preferred in patients with prior thoracotomy. Lead implantation via coronary sinus (CS) can be an alternative to conventional right ventricular pacing in this patient population.

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.