Impact of a Chronic Total Coronary Occlusion on the Incidence of Appropriate Implantable Cardioverter-Defibrillator Shocks and Mortality: A Substudy of the Dutch Outcome in ICD Therapy (DO-IT)) Registry.

BACKGROUND: Chronic total coronary occlusions (CTO) substantially increase the risk for sudden cardiac death. Among patients with chronic ischemic heart disease at risk for sudden cardiac death, an implantable cardioverter defibrillator (ICD) is the favored therapy for primary prevention of sudden cardiac death. This study sought to investigate the impact of CTOs on the risk for appropriate ICD shocks and mortality within a nationwide prospective cohort. METHODS AND RESULTS: This is a subanalysis of the nationwide Dutch-Outcome in ICD Therapy (DO-IT) registry of primary prevention ICD recipients in The Netherlands between September 2014 and June 2016 (n=1442). We identified patients with chronic ischemic heart disease (n=663) and assessed available coronary angiograms for CTO presence (n=415). Patients with revascularized CTOs were excluded (n=79). The primary end point was the composite of all-cause mortality and appropriate ICD shocks. Clinical follow-up was conducted for at least 2 years. A total of 336 patients were included, with an average age of 67±9 years, and 20.5% was female (n=69). An unrevascularized CTO was identified in 110 patients (32.7%). During a median follow-up period of 27 months (interquartile range, 24-32), the primary end point occurred in 21.1% of patients with CTO (n=23) compared with 11.9% in patients without CTO (n=27; P=0.034). Corrected for baseline characteristics including left ventricular ejection fraction, and the presence of a CTO was an independent predictor for the primary end point (hazard ratio, 1.82 [95% CI, 1.03-3.22]; P=0.038). CONCLUSIONS: Within this nationwide prospective registry of primary prevention ICD recipients, the presence of an unrevascularized CTO was an independent predictor for the composite outcome of all-cause mortality and appropriate ICD shocks.

Detection of atrial fibrillation in persons aged 65 years and above using a mobile electrocardiogram device.

BACKGROUND: Untreated atrial fibrillation (AF) often results in increased morbidity and mortality. Opportunistic AF screening in persons aged ≥ 65 years is recommended to identify patients with AF in order to prevent AF-related complications. OBJECTIVE: The aim of this study was to assess the feasibility of screening persons for AF with the Kardia mobile electrocardiogram device (MED) and to determine the percentage of newly detected AF cases by selective population screening in the Netherlands. METHODS: Persons aged ≥ 65 years, without a medical history of AF, in nursing homes, at public events or visiting the general practitioner (GP) were approached to participate. A Kardia MED smartphone ECG (sECG) was recorded and the CHA2DS2-VASc score was calculated. An automated AF algorithm classified the sECGs as 'sinus rhythm', 'AF' or 'unclassified'. In the case of AF, participants were referred to their GP. All sECGs were assessed by blinded experts. RESULTS: A total of 2168 participants were screened for AF. According to the expert's interpretation, 2.5% had newly detected AF, of whom 76.4% never experienced palpitations and 89.1% had a CHA2DS2-VASc score ≥ 2. The algorithm result was unclassified in 12.2% of cases, of which 95.5% were interpretable by experts. With expert opinion as the gold standard and excluding unclassified sECGs, the Kardia MED's negative and positive predictive value for detecting AF was 99.8% and 60.0%, respectively. CONCLUSION: Screening for AF using the Kardia MED is feasible and results in 2.5% newly detected AF cases. Expert interpretation of algorithm outcomes AF and unclassified is recommended.

Five-year safety and efficacy of leadless pacemakers in a Dutch cohort.

BACKGROUND: Adequate real-world safety and efficacy of leadless pacemakers (LPs) have been demonstrated up to 3 years after implantation. Longer-term data are warranted to assess the net clinical benefit of leadless pacing. OBJECTIVE: The purpose of this study was to evaluate the long-term safety and efficacy of LP therapy in a real-world cohort. METHODS: In this retrospective cohort study, all consecutive patients with a first LP implantation from December 21, 2012, to December 13, 2016, in 6 Dutch high-volume centers were included. The primary safety endpoint was the rate of major procedure- or device-related complications (ie, requiring surgery) at 5-year follow-up. Analyses were performed with and without Nanostim battery advisory-related complications. The primary efficacy endpoint was the percentage of patients with a pacing capture threshold ≤2.0 V at implantation and without ≥1.5-V increase at the last follow-up visit. RESULTS: A total of 179 patients were included (mean age 79 ± 9 years), 93 (52%) with a Nanostim and 86 (48%) with a Micra VR LP. Mean follow-up duration was 44 ± 26 months. Forty-one major complications occurred, of which 7 were not advisory related. The 5-year major complication rate was 4% without advisory-related complications and 27% including advisory-related complications. No advisory-related major complications occurred a median 10 days (range 0-88 days) postimplantation. The pacing capture threshold was low in 163 of 167 patients (98%) and stable in 157 of 160 (98%). CONCLUSION: The long-term major complication rate without advisory-related complications was low with LPs. No complications occurred after the acute phase and no infections occurred, which may be a specific benefit of LPs. The performance was adequate with a stable pacing capture threshold.

On-screen image-guided lead placement in cardiac resynchronization therapy: Feasibility and outcome in a multicenter setting.

Background: Image guidance to assist left ventricular (LV) lead placement may improve outcome after cardiac resynchronization therapy (CRT), but previous approaches and results varied greatly, and multicenter feasibility is lacking altogether. Objective: We sought to investigate the multicenter feasibility of image guidance for periprocedural assistance of LV lead placement for CRT. Methods: In 30 patients from 3 hospitals, cardiac magnetic resonance imaging was performed within 3 months prior to CRT to identify myocardial scar and late mechanical activation (LMA). LMA was determined using radial strain, plotted over time. Segments without scar but clear LMA were classified as optimal for LV lead placement, according to an accurate 36-segment model of the whole heart. LV leads were navigated using image overlay with periprocedural fluoroscopy. After 6 months, volumetric response and super-response were defined as ≥15% or ≥30% reduction in LV end-systolic volume, respectively. Results: Periprocedural image guidance was successfully performed in all CRT patients (age 66 ± 10 years; 59% men, 62% with nonischemic cardiomyopathy, 69% with left bundle branch block). LV leads were placed as follows: within (14%), adjacent (62%), or remote (24%) from the predefined target. According to the conventional 18-segment model, a remote position occurred only once (3%). On average, 86% of patients demonstrated a volumetric response (mean LV end-systolic volume reduction 36 ± 29%), and 66% of all patients were super-responders. Conclusion: On-screen image guidance for LV lead placement in CRT was feasible in a multicenter setting. Efficacy will be further investigated in the randomized controlled ADVISE (Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy) trial (NCT05053568).

Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial. METHODS AND RESULTS: The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections, and the need for invasive interventions. Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group, 49 complications occurred in 44 patients of which lead dysfunction was most frequent (HR: 0.69; P = 0.11). In both groups, half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047). CONCLUSION: This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice.

Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: Analysis of All Appropriate Therapy in the PRAETORIAN Trial.

BACKGROUND: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) showed noninferiority of subcutaneous implantable cardioverter defibrillator (S-ICD) compared with transvenous implantable cardioverter defibrillator (TV-ICD) with regard to inappropriate shocks and complications. In contrast to TV-ICD, S-ICD cannot provide antitachycardia pacing for monomorphic ventricular tachycardia. This prespecified secondary analysis evaluates appropriate therapy and whether antitachycardia pacing reduces the number of appropriate shocks. METHODS: The PRAETORIAN trial was an international, investigator-initiated randomized trial that included patients with an indication for implantable cardioverter defibrillator (ICD) therapy. Patients with previous ventricular tachycardia <170 bpm or refractory recurrent monomorphic ventricular tachycardia were excluded. In 39 centers, 849 patients were randomized to receive an S-ICD (n=426) or TV-ICD (n=423) and were followed for a median of 49.1 months. ICD programming was mandated by protocol. Appropriate ICD therapy was defined as therapy for ventricular arrhythmias. Arrhythmias were classified as discrete episodes and storm episodes (≥3 episodes within 24 hours). Analyses were performed in the modified intention-to-treat population. RESULTS: In the S-ICD group, 86 of 426 patients received appropriate therapy, versus 78 of 423 patients in the TV-ICD group, during a median follow-up of 52 months (48-month Kaplan-Meier estimates 19.4% and 17.5%; P=0.45). In the S-ICD group, 83 patients received at least 1 shock, versus 57 patients in the TV-ICD group (48-month Kaplan-Meier estimates 19.2% and 11.5%; P=0.02). Patients in the S-ICD group had a total of 254 shocks, compared with 228 shocks in the TV-ICD group (P=0.68). First shock efficacy was 93.8% in the S-ICD group and 91.6% in the TV-ICD group (P=0.40). The first antitachycardia pacing attempt successfully terminated 46% of all monomorphic ventricular tachycardias, but accelerated the arrhythmia in 9.4%. Ten patients with S-ICD experienced 13 electrical storms, versus 18 patients with TV-ICD with 19 electrical storms. Patients with appropriate therapy had an almost 2-fold increased relative risk of electrical storms in the TV-ICD group compared with the S-ICD group (P=0.05). CONCLUSIONS: In this trial, no difference was observed in shock efficacy of S-ICD compared with TV-ICD. Although patients in the S-ICD group were more likely to receive an ICD shock, the total number of appropriate shocks was not different between the 2 groups. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.

Dutch Outcome in Implantable Cardioverter-Defibrillator Therapy: Implantable Cardioverter-Defibrillator-Related Complications in a Contemporary Primary Prevention Cohort.

Background One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. Methods and Results Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverter-defibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0-2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. Conclusions One in 13 patients experiences at least one major implantable cardioverter-defibrillator-related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits.

Long-Term Outcome of the Randomized DAPA Trial.

BACKGROUND: The randomized DAPA trial (Defibrillator After Primary Angioplasty) aimed to evaluate the survival benefit of prophylactic implantable cardioverter defibrillator (ICD) implantation in early selected high-risk patients after primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction. METHODS: A randomized, multicenter, controlled trial compared ICD versus conventional medical therapy in high-risk patients with primary percutaneous coronary intervention, based on one of the following factors: left ventricular ejection fraction <30% within 4 days after ST-segment-elevation myocardial infarction, primary ventricular fibrillation, Killip class ≥2 or TIMI (Thrombolysis in Myocardial Infarction) flow <3 after percutaneous coronary intervention. ICD was implanted 30 to 60 days after MI. Primary end point was all-cause mortality at 3 years follow-up. The trial prematurely ended after inclusion of 266 patients (38% of the calculated sample size). Additional survival assessment was performed in February 2019 for the primary end point. RESULTS: A total of 266 patients, 78.2% males, with a mean age of 60.8±11.3 years, were enrolled. One hundred thirty-one patients were randomized to the ICD arm and 135 patients to the control arm. All-cause mortality was significant lower in the ICD group (5% versus 13%, hazard ratio, 0.37 [95% CI, 0.15-0.95]) after 3 years follow-up. Appropriate ICD therapy occurred in 9 patients at 3 years follow-up (5 within the first 8 months after implantation). After a median long-term follow-up of 9 years (interquartile range, 3-11), total mortality (18% versus 38%; hazard ratio, 0.58 [95% CI, 0.37-0.91]), and cardiac mortality (hazard ratio, 0.52 [95% CI, 0.28-0.99]) was significant lower in the ICD group. Noncardiac death was not significantly different between groups. Left ventricular ejection fraction increased ≥10% in 46.5% of the patients during follow-up, and the extent of improvement was similar in both study groups. CONCLUSIONS: In this prematurely terminated and thus underpowered randomized trial, early prophylactic ICD implantation demonstrated lower total and cardiac mortality in patients with high-risk ST-segment-elevation myocardial infarction treated with primary percutaneous coronary intervention. Registration: URL: https://www.trialregister.nl; Unique identifier: Trial NL74 (NTR105).

Elimination of Benign Ventricular Premature Beats or Ventricular Tachycardia with Catheter Ablation versus Two Different Optimal Antiarrhythmic Drug Treatment Regimens (Sotalol or Verapamil/Flecainide).

BACKGROUND: Symptomatic idiopathic ventricular arrhythmias (VA), including premature beats (VPB) and nonsustained ventricular tachycardia (VT) are commonly encountered arrhythmias. Although these VA are usually benign, their treatment can be a challenge to primary and secondary health care providers. Mainstay treatment is comprised of antiarrhythmic drugs (AAD) and, in case of drug intolerance or failure, patients are referred for catheter ablation to tertiary health care centers. These patients require extensive medical attention and drug regimens usually have disappointing results. A direct comparison between the efficacy of the most potent AAD and primary catheter ablation in these patients is lacking. The ECTOPIA trial will evaluate the efficacy of 2 pharmacological strategies and 1 interventional approach to: suppress the VA burden, improve the quality of life (QoL), and safety. HYPOTHESIS: We hypothesize that flecainide/verapamil combination and catheter ablation are both superior to sotalol in suppressing VA in patients with symptomatic idiopathic VA. STUDY DESIGN: The Elimination of Ventricular Premature Beats with Catheter Ablation versus Optimal Antiarrhythmic Drug Treatment (ECTOPIA) trial is a randomized, multicenter, prospective clinical trial to compare the efficacy of catheter ablation versus optimal AAD treatment with sotalol or flecainide/verapamil. One hundred eighty patients with frequent symptomatic VA in the absence of structural heart disease or underlying cardiac ischemia who are eligible for catheter ablation with an identifiable monomorphic VA origin with a burden ≥5% on 24-h ambulatory rhythm monitoring will be included. Patients will be randomized in a 1:1:1 fashion. The primary endpoint is defined as >80% reduction of the VA burden on 24-h ambulatory Holter monitoring. After reaching the primary endpoint, patients randomized to one of the 2 AAD arms will undergo a cross-over to the other AAD treatment arm to explore differences in drug efficacy and QoL in individual patients. Due to the use of different AAD (with and without ß-blocking characteristics) we will be able to explore the influence of alterations in sympathetic tone on VA burden reduction in different subgroups. Finally, this study will assess the safety of treatment with 2 different AAD and ablation of VA.

Subcutaneous or Transvenous Defibrillator Therapy.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies. METHODS: We conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD. The primary end point was the composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD) was 1.45. A superiority analysis was prespecified if noninferiority was established. Secondary end points included death and appropriate shocks. RESULTS: A total of 849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses. At a median follow-up of 49.1 months, a primary end-point event occurred in 68 patients in the subcutaneous ICD group and in 68 patients in the transvenous ICD group (48-month Kaplan-Meier estimated cumulative incidence, 15.1% and 15.7%, respectively; hazard ratio, 0.99; 95% confidence interval [CI], 0.71 to 1.39; P = 0.01 for noninferiority; P = 0.95 for superiority). Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30). Death occurred in 83 patients in the subcutaneous ICD group and in 68 in the transvenous ICD group (hazard ratio, 1.23; 95% CI, 0.89 to 1.70); appropriate shocks occurred in 83 and 57 patients, respectively (hazard ratio, 1.52; 95% CI, 1.08 to 2.12). CONCLUSIONS: In patients with an indication for an ICD but no indication for pacing, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks. (Funded by Boston Scientific; PRAETORIAN ClinicalTrials.gov number, NCT01296022.).

Quality of life after catheter and minimally invasive surgical ablation of paroxysmal and early persistent atrial fibrillation: results from the SCALAF trial.

AIMS: In the SCALAF trial, catheter-based pulmonary vein isolation (PVI) was as effective in long-term prevention of atrial fibrillation (AF) as minimally invasive thoracoscopic PVI and left atrial appendage ligation (MIPI). Catheter ablation (CA) resulted in significantly less major complications as compare to MIPI. We report quality of life (QOL) outcome in these patients. METHODS: In this study, 52 patients with symptomatic paroxysmal or early persistent AF were randomized to either MIPI or CA. QOL was assessed at baseline, 3, 6, and 12 months follow-up using the SF-36 Health Survey Questionnaire. AF-related symptoms were quantified at each follow-up visit using the European Heart Rhythm Association (EHRA) score. RESULTS: Median age was 57 years and 78% was male. Paroxysmal AF was present in 74%. At 3 months follow-up, physical role limitations (88.2 ± 29.5; versus 40.9 ± 44.0; P = 0.001, respectively) and bodily pain scores (95.5 ± 8.7; versus 76.0 ± 27.8; P = 0.021, respectively) were significantly higher after CA compared to MIPI, indicating less limitation in daily activity caused by physical problems and less pain after CA than after MIPI. AF symptoms assessed by the EHRA scores improved significantly at 3, 6, 12, and 24 months compared to baseline in both treatment groups (P < 0.001), with no significant differences between treatment groups. CONCLUSIONS: CA and MIPI ablation of AF both resulted in an improvement in several QOL measurements, although CA resulted in significantly less physical problems and bodily pain 3 months after treatment compared to MIPI. CLINICAL TRIAL NUMBER: ClinicalTrials.gov identifier: NCT00703157.

Hybrid Ventricular Tachycardia Ablation after Failed Percutaneous Endocardial and Epicardial Ablation.

INTRODUCTION: Recurrent ventricular tachycardia (VT) after percutaneous ablation is associated with a high morbidity and mortality. We assessed the feasibility of open chest extracorporeal circulation (ECC)-supported 3D multielectrode mapping and targeted VT substrate ablation in patients with previously failed percutaneous endocardial and epicardial VT ablations. METHODS: In patients with previously failed percutaneous endocardial and epicardial VT ablations and a high risk of hemodynamic collapse during the procedure, open chest ECC-supported mapping and ablation were performed in a hybrid EP lab setting. Electro-anatomic maps (3D) were acquired during sinus rhythm and VT using a multielectrode mapping catheter (HD grid; Abbott or Pentaray, Biosense Webster). Irrigated radiofrequency ablations of all inducible VT were performed with a contact force ablation catheter. RESULTS: Hybrid VT ablation was performed in 5 patients with structural heart disease (i.e., 3 with previous old myocardial infarction and 2 with nonischemic cardiomy-opathy) and recurrent VT. Acute procedural success was achieved in all patients. Four patients were successfully weaned off the ECC. In 1 patient with a severely reduced LVEF (16%), damage to the venous graft occurred after sternotomy and that patient died after 1 month. Four patients (80%) remained VT free after a median follow-up of 6 (IQR 4-10) months. CONCLUSION: In high-risk patients with previously failed percutaneous endocardial and epicardial VT ablations, open chest ECC-supported multielectrode epicardial mapping revealed a VT substrate in all of the patients, and targeted epicardial ablation abolished VT substrate in these patients.

Rationale and design of the PRAETORIAN-DFT trial: A prospective randomized CompArative trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation with and without DeFibrillation testing.

In transvenous implantable cardioverter-defibrillator (TV-ICD) implants, routine defibrillation testing (DFT) does not improve shock efficacy or reduce arrhythmic death but patients are exposed to the risk of complications related to DFT. The conversion rate of DFT in subcutaneous ICD (S-ICD) is high and first shock efficacy is similar to TV-ICD efficacy rates. STUDY DESIGN: The PRAETORIAN-DFT trial is an investigator-initiated, randomized, controlled, multicenter, prospective two-arm trial designed to demonstrate non-inferiority of omitting DFT in patients undergoing S-ICD implantation in which the S-ICD system components are optimally positioned. Positioning of the S-ICD will be assessed with the PRAETORIAN score. The PRAETORIAN score is developed to systematically evaluate implant position of the S-ICD system components which determine the defibrillation threshold on post-operative chest X-ray. A total of 965 patients, scheduled to undergo a de novo S-ICD implantation without contra-indications for either DFT strategy, will be randomized to either standard of care S-ICD implantation with DFT, or S-ICD implantation without DFT but with evaluation of the implant position using the PRAETORIAN score. The study is powered to claim non-inferiority of S-ICD implantation without DFT in de novo S-ICD patients in respect to the primary endpoint of first shock efficacy in spontaneous arrhythmia episodes. Patients with a high PRAETORIAN score (≥90) in the interventional arm of this study will undergo DFT according to the same DFT protocol as in the control arm. CONCLUSION: The PRAETORIAN-DFT trial is a randomized trial that aims to gain scientific evidence to safely omit a routine DFT after S-ICD implantation in patients with correct device positioning.

Renal sympathetic denervation induces changes in heart rate variability and is associated with a lower sympathetic tone.

BACKGROUND: Renal nerve stimulation (RNS) is used to localize sympathetic nerve tissue for selective renal nerve sympathetic denervation (RDN). Examination of heart rate variability (HRV) provides a way to assess the state of the autonomic nervous system. The current study aimed to examine the acute changes in HRV caused by RNS before and after RDN. METHODS AND RESULTS: 30 patients with hypertension referred for RDN were included. RNS was performed under general anesthesia before and after RDN. Heart rate (HR) and blood pressure (BP) were continuously monitored. HRV characteristics were assessed 1 min before and after RNS and RDN. RNS before RDN elicited a maximum increase in systolic BP of 45 (± 22) mmHg which was attenuated to 13 (± 12) mmHg (p < 0.001) after RDN. RNS before RDN decreased the sinus cycle length from 1210 (± 201) ms to 1170 (± 203) ms (p = 0.03), after RDN this effect was blunted (p = 0.59). The LF/HF ratio in response to RNS changed from ∆ + 0.448 (± 0.550) before RDN to ∆ - 0.656 (± 0.252) after RDN (p = 0.02). Selecting patients off beta-blockade (n = 11), the RNS-induced changes in HRV components before versus after RDN were more pronounced (LF/HF ratio ∆ + 0.900 ± 1.171 versus ∆ - 0.828 ± 0.519, p = 0.01), whereas changes in HRV parameters in patients on beta-blockade (n = 19) were no longer significant. In patients with diabetes mellitus (n = 7), RNS induced no changes in HRV parameters (LF/HF ratio ∆ - 0.039 ± 0.103 versus ∆ - 0.460 ± 0.491, p = 0.92). CONCLUSION: RNS induces changes in HRV suggesting increased sympathetic activity. Conversely, after RDN, the RNS-induced changes in HRV suggesting a lower sympathetic autonomic balance. These changes were most pronounced in beta-blocker naïve patients and not present in patients with diabetes mellitus. These findings could support RNS-guided RDN to optimize results.

Randomized Controlled Trial of Surgical Versus Catheter Ablation for Paroxysmal and Early Persistent Atrial Fibrillation.

BACKGROUND: Current guidelines recommend both percutaneous catheter ablation (CA) and surgical ablation in the treatment of atrial fibrillation, with different levels of evidence. No direct comparison has been made between minimally invasive thoracoscopic pulmonary vein isolation with left atrial appendage ligation (surgical MIPI) versus percutaneous CA comprising of pulmonary vein isolation as primary treatment of atrial fibrillation. We, therefore, conducted a randomized controlled trial comparing the safety and efficacy of these 2 treatment modalities. METHODS: Eighty patients were enrolled in the study and underwent implantable loop recorder implantation. Twenty-eight patients did not reach randomization criteria. A total of 52 patients with symptomatic paroxysmal or early persistent atrial fibrillation were randomized, 26 to CA and 26 to surgical MIPI. The primary end point was defined as freedom of atrial tachyarrhythmias, without the use of antiarrhythmic drugs. The safety end point was freedom of complications. RESULTS: Median age was 57 years (range, 37-75), and 78% were men. Paroxysmal atrial fibrillation was present in 74%. Follow-up duration was ≥2 years in all patients. CA was noninferior to MIPI in terms of single-procedure arrhythmia-free survival after 2 years of follow-up (56.0% versus 29.2%; HR, 0.56; 95% CI, 0.26-1.20; log-rank P=0.059). Procedure-related major adverse events occurred significantly more often in MIPI than CA (20.8% versus 0%; P=0.029). CONCLUSIONS: Percutaneous pulmonary vein isolation was noninferior to MIPI in terms of efficacy and resulted in less complications. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00703157.

Changes in arterial pressure hemodynamics in response to renal nerve stimulation both before and after renal denervation.

BACKGROUND: Renal nerve denervation (RDN) is developed as a potential treatment for hypertension. Recently, we reported the use of renal nerve stimulation (RNS) to localize sympathetic nerve tissue for subsequent selective RDN. The effects of RNS on arterial pressure dynamics remain unknown. The current study aimed to describe the acute changes in arterial pressure dynamics response to RNS before and after RDN. METHODS AND RESULTS: Twenty six patients with drug-resistant hypertension referred for RDN were included. RNS was performed under general anesthesia before and after RDN. We continuously monitored heart rate (HR) and invasive femoral blood pressure (BP). Augmentation pressure (AP) and index (Aix), pulse pressure (PP), time to reflected wave, maximum systolic BP and dicrotic notch were calculated. Systolic and diastolic BP at site of maximum response significantly increased in response to RNS (120 ± 16/62 ± 9 to 150 ± 22/75 ± 15 mmHg) (p < 0.001/< 0.001), whereas after RDN no RNS-induced BP change was observed (p > 0.10). RNS increased Aix (29 ± 11 to 32 ± 13%, p = 0.005), PP (59 ± 14 to 75 ± 17 mmHg, p < 0.001), time to reflected wave (63 ± 18 to 71 ± 25 ms, p = 0.004) and time to maximum systolic pressure (167 ± 36 to 181 ± 46 ms, p = 0.004) before RDN, whereas no changes were observed after RDN (p > 0.18). All changes were BP dependent. RNS had no influence on HR or the time to dicrotic notch (p > 0.12).   CONCLUSION: RNS induces temporary rises in Aix, PP, time to maximum systolic pressure and time to reflected wave. These changes are BP dependent and were completely blunted after RDN.

Mechanical power sheath mediated recanalization and lead implantation in patients with venous occlusion: Technique and results.

INTRODUCTION: Chronic venous occlusion hampers lead revisions and upgrades in patients with a cardiac implantable electronic devices (CIEDs). This can make cardiothoracic surgery, venoplasty, or contra-lateral implantation of leads with tunneling necessary. A technique using venous recanalization may be a preferred alternative. We assessed the efficacy and safety of this new technique. METHODS AND RESULTS: From 2009 to 2016, all consecutive patients planned for lead revision or upgrade with known chronic venous occlusion were studied. All patients underwent extraction of an existing malfunctional or functional CIED lead with the Cook Evolution mechanical power sheath. By using the lumen of the sheath, endovascular access to the heart was obtained for new leads. Forty-two patients (107 leads, 2.6 ± 1.1) were included. The indication for this procedure was replacement of malfunctional leads (n = 35, 83%) or device upgrade (n = 7, 17%). In total, 77 leads were extracted (30 leads stayed in situ) with a mean age at time of extraction of 8.4 years. Because of damage to bystander leads during extraction, two additional leads (one RA lead, one LV lead) were extracted. Clinical success was achieved in 41 patients (97%) and complete success in 39 patients (93%). There were two minor complications (two pocket hematomas, managed conservatively) and one major complication (tamponade, needing thoracotomy). Mean procedure time was 3.0 hours (median, 2.0; range, 1:28-5:35 hours) with a mean fluoroscopy time of 14.9 ± 12.5 minutes. CONCLUSIONS: The technique of Evolution-mediated recanalization in case of lead revisions or upgrades is feasible with an acceptable safety profile and high efficacy.

Preliminary findings on the safety of 1.5 and 3 Tesla magnetic resonance imaging in cardiac pacemaker patients.

INTRODUCTION: Modern pacemakers are designed to allow patients to undergo magnetic resonance imaging (MRI) under a set of specific conditions. Aim of this study is to provide confirmatory evidence of safety and performance of a new pacing system (ImageReady™, Boston Scientific) in patients undergoing 1.5 and 3T MRI. METHODS AND RESULTS: Two prospective, nonrandomized, single-arm studies were designed to provide confirmatory data of no impact of MRI on device function, lead parameters, and patient conditions in subjects implanted with the system undergoing a clinically non-indicated 1.5T and 3T MRI, respectively. Device measurements were done within 1 hour before and after the scan and at 1 month follow-up. Thirty-two subjects underwent MRI visit (17 subjects with 1.5T MRI and 15 subjects with 3T MRI). There were no unanticipated adverse effects related to the pacemaker. Device measurements taken pre- and post-MRI scan did not show any clinical relevant change that could indicate an effect of the MRI on the device or at the lead-tissue interface (RV threshold change: 0.01 ± 0.13 V, P = 0.60; RA threshold change: 0.01 ± 0.11 V, P = 0.53; R wave change: -0.44 ± 1.73 mV, P = 0.36; R wave change: 0.12 ± 1.67 mV, P = 0.73), with data confirmed at 1-month follow-up visit. CONCLUSION: The study documented safety of the pacing system in the 1.5T and 3T MRI environment by showing no adverse events related to device or MRI scan. Additional data are required to cover the more complex scenarios involving different diagnostic needs, conditions of use, clinical conditions, and new emerging technologies.

Predictors and long-term outcome of super-responders to cardiac resynchronization therapy.

BACKGROUND: The level of improvement in left ventricular ejection fraction (LVEF) in super-responders to cardiac resynchronization therapy (CRT) is exceptional. However, the long-term prognosis remains unknown in a large population. HYPOTHESIS: Whether super-responders haven good long-term outcomes. METHODS: We registered 347 patients with primary CRT-D indication. Super-response was defined by LVEF >50% at follow-up echocardiogram. Best-subset regression analysis identified predictors of super-response. Endpoints were major adverse cardiac events (MACE; eg, all-cause mortality or heart failure hospitalization, cardiac death, and appropriate ICD therapy). RESULTS: Fifty-six (16%) patients with LVEF >50% were classified as super-responders. Female sex (OR: 3.06, 95% CI: 1.54-6.05), nonischemic etiology (OR: 2.70, 95% CI: 1.29-5.68), higher LVEF at baseline (OR: 1.07, 95% CI: 1.02-1.13), and wider QRS duration (OR: 1.17, 95% CI: 1.04-1.32) were predictors of super-response. Cumulative incidence of MACE at a median of 5.3 years was 18% in super-responders, 22% in responders, and 51% in nonresponders (P < 0.001). None of super responders died from cardiac death, compared to 9% of responders and 25% of non-responders (P < 0.001). None of super-responders experienced appropriate ICD therapy, compared with 10% of responders and 21% of non-responders (P < 0.001). In super-responders, the adjusted hazard ratio was 0.37 (95% CI: 0.19-0.73) for MACE and 0.44 (95% CI: 0.20-0.95) for total mortality, compared with non-responders. CONCLUSIONS: Female sex, non-ischemic etiology, higher baseline LVEF, and wider QRS duration were independently associated with super-response. Super-response was associated with persistent excellent prognosis regarding survival and appropriate ICD therapy during long-term follow-up.