Impact of cryoballoon application abortion due to phrenic nerve injury on reconnection rates: a YETI subgroup analysis.

AIMS: Cryoballoon (CB)-based pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). The most frequent complication during CB-based PVI is right-sided phrenic nerve injury (PNI) which is leading to premature abortion of the freeze cycle. Here, we analysed reconnection rates after CB-based PVI and PNI in a large-scale population during repeat procedures. METHODS AND RESULTS: In the YETI registry, a total of 17 356 patients underwent CB-based PVI in 33 centres, and 731 (4.2%) patients experienced PNI. A total of 111/731 (15.2%) patients received a repeat procedure for treatment of recurrent AF. In 94/111 (84.7%) patients data on repeat procedures were available. A total of 89/94 (94.7%) index pulmonary veins (PVs) have been isolated during the initial PVI. During repeat procedures, 22 (24.7%) of initially isolated index PVs showed reconnection. The use of a double stop technique did non influence the PV reconnection rate (P = 0.464). The time to PNI was 140.5 ± 45.1 s in patients with persistent PVI and 133.5 ± 53.8 s in patients with reconnection (P = 0.559). No differences were noted between the two populations in terms of CB temperature at the time of PNI (P = 0.362). The only parameter associated with isolation durability was CB temperature after 30 s of freezing. The PV reconnection did not influence the time to AF recurrence. CONCLUSION: In patients with cryoballon application abortion due to PNI, a high rate of persistent PVI rate was found at repeat procedures. Our data may help to identify the optimal dosing protocol in CB-based PVI procedures. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03645577?term=YETI&cntry=DE&draw=2&rank=1 ClinicalTrials.gov Identifier: NCT03645577.

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.

Implantable cardioverter defibrillator use for primary prevention in ischaemic and non-ischaemic heart disease-indications in the post-DANISH trial era: results of the European Heart Rhythm Association survey.

Implantable cardioverter-defibrillator (ICD) is the standard of care for prevention of sudden cardiac death (SCD) in high-risk patients. For primary prevention of SCD, in patients with ischaemic heart disease, there is more robust data on the effect of ICD therapy compared with patients with non-ischaemic heart disease, but current real-life practice may differ substantially. The aim of this European Heart Rhythm Association survey was to evaluate the clinical practice regarding implantation of ICD for primary prevention among European countries in patients with non-ischaemic and ischaemic heart disease. Furthermore, we wanted to investigate the impact of the results of the recently published DANISH trial on clinical practice among European countries. In total, 48 centres from 17 different countries responded to the questionnaire. The majority did not implant ICD for primary prevention on a regular basis in patients with non-ischaemic heart disease despite current guidelines. Also, centres have changed their indications after the recent report on the efficacy of ICD in these patients. In patients with ischaemic heart disease, the guidelines for primary prevention ICD were followed on a regular basis, and no relevant change in indications were reported.

Acute and Long-Term Scar Characterization of Venous Ethanol Ablation in the Left Ventricular Summit.

BACKGROUND: Venous ethanol ablation (VEA) can be effective for ventricular arrhythmias from the left ventricular summit (LVS); however, there are concerns about excessive ablation by VEA. OBJECTIVES: The purpose of this study was to delineate and quantify the location, extent, and evolution of ablated tissue after VEA as an intramural ablation technique in the LVS. METHODS: VEA was performed in 59 patients with LVS ventricular arrhythmias. Targeted intramural veins were selected by electrograms from a 2F octapolar catheter or by guide-wire unipolar signals. Median ethanol delivered was 4 mL (IQR: 4-7 mL). Ablated areas were estimated intraprocedurally as increased echogenicity on intracardiac echocardiography (ICE) and incorporated into 3-dimensional maps. In 44 patients, late gadolinium enhancement cardiac magnetic resonance (CMR) imaged VEA scar and its evolution. RESULTS: ICE-demonstrated increased intramural echogenicity (median volume of 2 mL; IQR: 1.7-4.3) at the targeted region of the 3-dimensional maps. Post-ethanol CMR showed intramural scar of 2.5 mL (IQR: 2.1-3.5 mL). Early (within 48 hours after VEA) CMR showed microvascular obstruction (MVO) in 30 of 31 patients. Follow-up CMR after a median of 51 (IQR: 41-170) days showed evolution of MVO to scar. ICE echogenicity and CMR scar volumes correlated with each other and with ethanol volume. Ventricular function and interventricular septum remained intact. CONCLUSIONS: VEA leads to intramural ablation that can be tracked intraprocedurally by ICE and creates regions of MVO that are chronically replaced by myocardial scar. VEA scar volume does not compromise septal integrity or ventricular function.

Phrenic Nerve Injury During Cryoballoon-Based Pulmonary Vein Isolation: Results of the Worldwide YETI Registry.

BACKGROUND: Cryoballoon-based pulmonary vein isolation (PVI) has emerged as an effective treatment for atrial fibrillation. The most frequent complication during cryoballoon-based PVI is phrenic nerve injury (PNI). However, data on PNI are scarce. METHODS: The YETI registry is a retrospective, multicenter, and multinational registry evaluating the incidence, characteristics, prognostic factors for PNI recovery and follow-up data of patients with PNI during cryoballoon-based PVI. Experienced electrophysiological centers were invited to participate. All patients with PNI during CB2 or third (CB3) and fourth-generation cryoballoon (CB4)-based PVI were eligible. RESULTS: A total of 17 356 patients underwent cryoballoon-based PVI in 33 centers from 10 countries. A total of 731 (4.2%) patients experienced PNI. The mean time to PNI was 127.7±50.4 seconds, and the mean temperature at the time of PNI was -49±8°C. At the end of the procedure, PNI recovered in 394/731 patients (53.9%). Recovery of PNI at 12 months of follow-up was found in 97.0% of patients (682/703, with 28 patients lost to follow-up). A total of 16/703 (2.3%) reported symptomatic PNI. Only 0.06% of the overall population showed symptomatic and permanent PNI. Prognostic factors improving PNI recovery are immediate stop at PNI by double-stop technique and utilization of a bonus-freeze protocol. Age, cryoballoon temperature at PNI, and compound motor action potential amplitude loss >30% were identified as factors decreasing PNI recovery. Based on these parameters, a score was calculated. The YETI score has a numerical value that will directly represent the probability of a specific patient of recovering from PNI within 12 months. CONCLUSIONS: The incidence of PNI during cryoballoon-based PVI was 4.2%. Overall 97% of PNI recovered within 12 months. Symptomatic and permanent PNI is exceedingly rare in patients after cryoballoon-based PVI. The YETI score estimates the prognosis after iatrogenic cryoballoon-derived PNI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03645577. Graphic Abstract: A graphic abstract is available for this article.

Mapping and isolation of the pulmonary veins using the PVAC catheter.

OBJECTIVES: We aimed to investigate the feasibility, efficacy, and safety of the pulmonary vein ablation catheter (PVAC) catheter (a novel multielectrode catheter using duty-cycled bipolar and unipolar radiofrequency energy, Medtronic, Minneapolis, MN, USA) to completely isolate the pulmonary veins (PVs). METHODS: Twenty-seven patients (60 +/- 8 years) with paroxysmal atrial fibrillation (AF) underwent PV isolation with the PVAC catheter. PVAC was used for both mapping and isolation of the PVs (PVAC-guided ablation). After PVAC ablation, presence/absence of PV potentials (PVP) was verified using a conventional circular mapping catheter. In case of residual PVP on the circular catheter, PVAC ablation was continued. RESULTS: After PVAC-guided ablation 99 of 106 PVs (93%) and 21 of 27 patients (78%) were proven to be isolated. Failure to isolate was due to a mapping failure in four right-sided PVs and a true ablation failure in three right-sided PVs. After continued PVAC ablation, 103 of 106 PVs (97%) and 25 of 27 patients (93%) were shown to be isolated. The total procedural time from femoral vein access to complete catheter withdrawal was 176 +/- 25 minutes. The actual dwelling-time of the PVAC within the left atrium was 102 +/- 37 minutes. Esophageal T degrees rise to >38.5 degrees occurred in nine of 19 monitored patients (47%). CONCLUSIONS: (1) PVAC-guided ablation (i.e., mapping and ablation with a single catheter) results in isolation of all PVs in 73% of the patients. (2) An additional circular mapping catheter is required to increase complete isolation rate to 93% of the patients. (3) Given the esophageal T degrees rise in almost 50% of patients, safety precautions are needed.

Double-balloon technique for retrograde venous ethanol ablation of ventricular arrhythmias in the absence of suitable intramural veins.

BACKGROUND: Venous ethanol infusion via an occlusive balloon has been used as a bailout approach to treat ablation-refractory ventricular arrhythmias (VAs). Unfavorable venous anatomy (lack of intramural veins at the targeted site or collateral vein-ethanol shunting) limits its efficacy. Blocking collateral flow with a second balloon may optimize myocardial ethanol delivery. OBJECTIVE: The purpose of this study was to validate the "double-balloon" approach to enhance ethanol delivery in cases of unfavorable venous anatomy. METHODS: Eight patients referred after failed ablations (3 left ventricular [LV] summit, 5 scar-related ventricular tachycardia) underwent endocardial mapping and additional radiofrequency ablation without VA resolution. Coronary veins were mapped using a multipolar catheter or wire, and selective venograms were obtained. The double balloon was used when (1) distal collateral branches shunted flow away from the targeted region; (2) the target vein had optimal signals only proximally; or (3) a large vein was targeted that had multiple branches for a large area of interest. RESULTS: Acute successful ethanol infusion myocardial delivery and resolution of VA was accomplished using the posterolateral LV veins (n = 2 patients, 3 procedures), lateral LV vein (n = 1), apical anterior interventricular vein (AIV; n = 1), middle cardiac vein (n = 1), and septal branches of the AIV (n = 3). At median follow-up of 313.5 days, 2 patients experienced recurrence. CONCLUSION: The double-balloon technique can enhance ethanol delivery to target isolated vein segments, block collateral flow, or target extensive areas, and can expand the utility of venous ethanol for treatment of VAs.

Intramural Venous Ethanol Infusion for Refractory Ventricular Arrhythmias: Outcomes of a Multicenter Experience.

OBJECTIVES: The aim of this study was to assess the long-term efficacy and outcomes of retrograde venous ethanol ablation in treating ventricular arrhythmias (VAs). BACKGROUND: Retrograde coronary venous ethanol ablation (RCVEA) can be effective for radiofrequency ablation (RFA)-refractory VAs, particularly those arising in the LV summit (LVS). METHODS: Patients with drug and RFA-refractory VAs were considered for RCVEA after RF failure attempts. Intramural coronary veins (tributaries of the great cardiac, anterior interventricular, lateral cardiac, posterolateral, and middle cardiac) were mapped using an angioplasty wire. Ethanol infusion was delivered in veins with appropriate signals. RESULTS: Of 63 patients (age 63 ± 14 years; 60% men) with VAs (71% extrasystole, 29% ventricular tachycardia, 76% LVS origin), RCVEA was performed in 56 patients who had suitable vein branches. These were defined as those amenable to cannulation and with intramural signals that preceded those mapped in the epicardium or endocardium and had better matching pace maps or entrainment responses. Seven patients had no suitable veins and underwent RFA. In 38 of 56 (68%) patients, the VAs were successfully terminated exclusively with ethanol infusion. In 17 of 56 (30%) patients, successful ablation was achieved using ethanol with adjunctive RFA in the vicinity of the infused vein due to acute recurrence or ethanol-induced change in VA morphology. Overall, isolated or adjuvant RCVEA was successful in 55 of 56 (98%) patients. At 1-year follow-up, 77% of patients were free of recurrent arrhythmias. Procedural complications included 2 venous dissections that led to pericardial effusions. CONCLUSIONS: RCVEA offers a significant long-term effective treatment for patients with drug and RF-refractory VAs.

Biventricular pacing in hypertrophic obstructive cardiomyopathy: a pilot study.

BACKGROUND: Right ventricular apex pacing for gradient reduction in hypertrophic obstructive cardiomyopathy (HOCM) with severe left ventricular (LV) obstruction has yielded conflicting results. OBJECTIVE: The purpose of this study was to assess the feasibility and effectiveness of biventricular pacing in HOCM. METHODS: Transvenous biventricular pacing was attempted in 12 severely symptomatic HOCM patients. Optimal intervals were programmed after implant. Echocardiographic LV pressure gradient and synchrony were assessed. LV lead implantation was successful in 9 patients. Optimal pacing mode was biventricular in 6 patients, left ventricular only in 2 patients, and right ventricular only in 1 patient. RESULTS: Functional capacity and quality of life progressively improved. New York Heart Association functional class decreased from 3.2 ± 0.4 at baseline to 1.9 ± 0.3 at 3 months and to 1.4 ± 0.5 at 1 year (P <.05); 6-minute walk test increased from 349 ± 116 m at baseline to 454 ± 144 m at 3 months and to 517 ± 206 m (P <.05); and quality of life increased from 54 ± 16 points at baseline to 28 ± 13 points at 3 months and 27 ± 15 points at 1 year (P <.05). There was also a progressive reduction in LV gradient from 74 ± 23 mmHg at baseline to 50 ± 27 mmHg acutely, 40 ± 26 mmHg at 3 months, and 28 ± 17 mmHg at 1 year (P <.05). Gradient reduction was associated with diminished peak longitudinal displacement of the LV septum and earlier displacement of the lateral wall. A progressive reduction of LV mass was observed, from 356 ± 110 g at baseline to 315 ± 70 g at 3 months (P = .13) and to 284 ± 42 g at 1 year (P <.05). CONCLUSION: Biventricular pacing is feasible and usually the best configuration for gradient reduction in HOCM. Biventricular pacing reduces LV hypertrophy.