Lead extractions: dissecting adhesions up to the lead-tip of the right ventricle: safety and success-rates.

AIMS: Goal of Transvenous Lead Extraction (TLE) is complete removal of all targeted leads, without complications. Despite counter traction manoeuvres, efficacy rates are often hampered by broken right ventricle lead (RV-lead) tips. Mechanically powered lead extraction (Evolution sheath) is effective, however safety of dissection up to the lead tip is unclear. Therefore, we examined the feasibility and safety of RV-lead extraction requiring dissection up to the myocardium. METHODS AND RESULTS: From 2009 to 2018, all TLE in the Isala Heart Centre (Zwolle, The Netherlands) requiring the hand-powered mechanical Evolution system to extract RV-leads (n = 185) were examined from a prospective registry. We assessed 4 groups: TLE with the first generation Evolution (n = 43) with (A1,n = 18) and without (A2,n = 25) adhesions up to the myocardium and TLE with the Novel R/L type (n = 142) of sheath with (B1, n = 59) and without (B2, n = 83) adhesions up to the myocardium. Complete success rate in Group B was significantly higher than group A (96.5 vs 76.7%, p = 0.0354). When comparing the patients with adhesions up to the myocardium, total complete success is higher in the R/L group (61.1% vs 90.5%, p = 0.0067). There were no deaths. Overall major complication rates were low (2/185; 1.1%) and there was no statistically significant difference in major and minor complications between the two groups. CONCLUSION: Extraction strategy with the bidirectional Evolution R/L sheath for right ventricular leads with adhesions up to the myocardium is safe and feasible.

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.

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.

Long-term outcome of catheter ablation in post-infarction recurrent ventricular tachycardia.

OBJECTIVES: Severe LV dysfunction and advanced age are associated with VT recurrence after catheter ablation in patients with post-infarction drug-refractory VT. We present retrospective analysis of long-term outcome after single and repeat VT ablation procedures in patients with ischemic heart disease. DESIGN: Patients with recurrent VT post infarction who underwent catheter ablation between 2006 and 2017 in Isala Heart Centre were retrospectively analyzed. Univariate and multivariate analysis were used to identify predictors of arrhythmia recurrence post ablation. Patients were allocated to subgroups based on LVEF: severe (<30%), moderate (30-40%) and mild LV dysfunction (41-51%) and analyzed with log rank test. RESULTS: A total of 144 patients were included. Two years VT free survival after a single procedure was 56.6% with median follow-up 46 [17-78] months. Recurrence of VT postablation wash high among patients with an old anteroseptal MI and LVEF < 30% with multiple morphologies of inducible VTs, indicating an extensive and complex substrate. Patients who underwent repeat ablations (27.1%) had significant more often LV aneurysms (20.5% vs. 7.6%, p = .03) and electrical storms (38.5% vs. 21.9%, p = .04). VT free survival was higher in patients with LVEF 41-51% compared to LVEF < 30% (71.4% vs. 47.8%, p = .01). In multivariate analysis, LVEF < 30% (vs 41-51%) was an independent predictor of arrhythmia recurrence (HR = 2.16, CI 1.15-4.06, p = .02). CONCLUSIONS: In patients with ischemic VT, success rate of ablation was highest among patients with preserved LV function and recurrent VT and ES was highest among patients with severe LV dysfunction after single and multiple ablation procedures.

Success and complication rates of lead extraction with the first- vs. the second-generation Evolution mechanical sheath.

AIMS: The Evolution sheath (Cook Medical, USA) is a power sheath frequently used for chronic lead extraction. In 2013, a novel type (bidirectional) of Evolution sheath (the RL type) was introduced. We evaluated differences in success and complication rates of the two types. METHODS AND RESULTS: From 2009 to 2015, all lead extractions requiring the use of an Evolution sheath were prospectively examined. According to the current guidelines, complete procedural success was defined as the removal of all targeted lead materials. Clinical success was the retention of a small portion of the lead, and failure was the inability to achieve either complete procedural or clinical success or the development of any permanently disabling complication. The Evolution sheath was used to extract 149 leads in 103 patients. The first 56 leads were extracted with the original unidirectional sheath, and 93 leads were extracted with the novel bidirectional R/L type. The median age of the lead at the time of extraction was 6.8 vs. 9.1 years (P = 0.007). Complete procedural success was higher for the Evolution R/L (80.0 vs. 98%, P = 0.0004). Clinical success rate was 98 vs. 99%. There were no major complications and 6 (12.0%) vs. 2 (3.8%) minor complications (P = 0.153). We did not observe changes in success rates or complications over time, meaning that the difference cannot be explained by learning curve. CONCLUSION: Use of the novel Evolution R/L sheath vs. the original Evolution sheath was associated with significant higher complete success rates, without major complications and with a trend towards the reduction of minor complications.

Lead extractions: the Zwolle experience with the Evolution mechanical sheath.

AIMS: The Evolution sheath (Cook, USA) is a power sheath with a cutting screw tip operated by mechanical rotation. It has been reported to be an effective tool for chronic lead extraction. We evaluated the safety and efficacy of this system. METHODS AND RESULTS: From 2009 to 2014, all lead extractions requiring the use of an Evolution sheath were prospectively examined. In 77 patients, 111 leads were extracted. The first 57 leads were extracted with the original unidirectional sheath, and since 2013, 54 leads were extracted with the bidirectional R/L type. According to the current guidelines, complete procedural success was defined as the removal of all targeted lead material. Clinical success was the retention of a small portion of the lead, and failure was the inability to achieve either complete procedural or clinical success or the development of any permanently disabling complication. The Evolution sheath was used to extract 111 leads in 77 patients. The median age of the lead at time of extraction was 8.0 years (median 6.9, interquartile range 6.4, minimum: 0.6 and maximum: 34.4), with a clinical success rate of 98% and a complete procedural success of 88%. Complete procedural success was higher for the R/L type Evolution sheath (96 vs. 80%, P = 0.006). There were 21 (19%) implantable cardioverter defibrillator leads, 22 (20%) right ventricular pacing leads, 60 (54%) right atrial leads, and 8 (7%) left ventricular leads. There were no major complications and six (8%) minor complications. There was no need for the usage of a femoral tool or snares. CONCLUSION: Use of Evolution for lead extractions seems to be safe and effective, with a high clinical success rate.

Ablation of focal atrial tachycardia from the non-coronary aortic cusp: case series and review of the literature.

AIMS: Focal atrial tachycardia successfully ablated from the non-coronary cusp (NCC) is rare. Our aim was to describe the characteristics of mapping and ablation therapy of NCC focal atrial tachycardias and to provide a comprehensive review of the literature. METHODS AND RESULTS: Seven patients (age 40 ± 9 years) with symptomatic, drug-refractory atrial tachycardia were referred for electrophysiological study. Extensive right and left atrial mapping revealed atrial tachycardia near His in all patients but either failed to identify a successful ablation site or radiofrequency applications only resulted in temporary termination of the tachycardia. Mapping and ablation of the NCC were performed retrogradely via the right femoral artery. Mapping of the NCC demonstrated earliest atrial activation during atrial tachycardia 38 ± 14 ms (ranging 17-56 ms) before the onset of the P-wave. Earliest atrial activation in the NCC was earlier than earliest activation in the right atrium and left atrium in all patients. The P-wave morphology was predominantly negative in the inferior leads and biphasic in leads V1 and V2. The tachycardia was successfully terminated by radiofrequency application in 10 ± 6 s (2-16 s), without complications. All patients were free of symptoms during a follow-up of 19 ± 9 months. Literature search revealed 18 reports (91 patients) describing NCC focal atrial tachycardia, with 99% long-term ablation success with a 1% complication rate. CONCLUSION: Symptomatic focal atrial tachycardia near His may originate from the NCC and can be treated safely and effectively with radiofrequency ablation.

Response to cardiac resynchronization therapy as assessed by time-based speckle tracking imaging.

BACKGROUND: Response to cardiac resynchronization therapy (CRT) is still difficult to predict with previously investigated dyssynchrony indices. The predictive value of speckle tracking strain analysis has not been fully delineated yet. The objective of this study was to assess the predictive value of longitudinal strain (LS) and radial strain (RS) speckle tracking measurements on echocardiographic and clinical response to CRT. METHODS: A total of 138 consecutive patients with functional class II-IV heart failure who underwent CRT were studied. Echocardiography was performed at baseline and during follow-up. Six different time-based left ventricular (LV)-dyssynchrony indices were measured with LS and RS. Echocardiographic response to CRT was defined as a reduction in LV end-systolic volume ≥15% and clinical response as survival without heart failure hospitalization. Multivariable analyses were performed to adjust for potential confounding factors. RESULTS: Echocardiographic and clinical follow-up was 22 ± 8 and 42 ± 8 months, respectively. Ninety-six patients (70%) were classified as echocardiographic responders and 114 patients (83%) survived without heart failure hospitalization. QRS duration and nonischemic etiology predicted echocardiographic response to CRT. None of the speckle tracking indices was different between echocardiographic responders and nonresponders to CRT. Regarding clinical response, only maximal delay between six segments in four-chamber view measured with LS was different between responders and nonresponders, with 154-ms delay as the optimal cut-off value. Neither stratified analyses in patients with sinus rhythm nor multivariable analyses did change these findings. CONCLUSION: Of all time-based measured speckle tracking indices, only maximal delay between six segments in four-chamber view as assessed with LS was associated with clinical response to CRT.

Mechanical and electrical dysfunction of Riata implantable cardioverter-defibrillator leads.

AIM: Riata implantable cardioverter-defibrillator leads are prone to failure by conductor externalization and/or electrical dysfunction. The objectives of this study were to determine the predictors of the Riata lead failure, to assess the association of conductor externalization and electrical lead failure, and to analyse the rates of lead failure over time. METHODS AND RESULTS: Of 273 implanted Riata leads in our centre, 197 were investigated according to the Riata recall protocol, including electrical measurements by device interrogation and annually fluoroscopy. During a mean follow-up period of 5.6 ± 1.4 years, Riata lead failure was 18.8% (37 of 197) for externalization and 17.3% (34 of 197) for electrical lead failure. Electrical lead failure was correlated with time after implant. Externalization and electrical dysfunction co-existed in only 6 of 197 (3%) patients and were not related (Phi's coefficient -0.013, P = 0.85). During the second annual screening, 145 (73.6%) patients underwent fluoroscopy and 9 patients had novel externalizations resulting in an incidence of 6.72%/patient/year which was higher than expected based on cross-sectional analysis. Besides, there was a significant increase in the extent of externalization (17.65 ± 11.14 mm vs. 21.77 ± 11.95 mm, P = 0.001). In multivariate Cox regression analysis, non-ischaemic cardiomyopathy and impaired LVEF were independent predictors of externalization, and 7 Fr lead was a predictor of electrical lead failure. CONCLUSION: Riata leads show progressive and high externalization rates without correlation between externalization and electrical lead failure. Non-ischaemic cardiomyopathy and impaired LVEF are independent predictors of structural lead failure in cross-sectional analysis, whereas 7 Fr lead is a predictor of electrical lead failure.

Assessment of left ventricular dyssynchrony in pacing-induced left bundle branch block compared with intrinsic left bundle branch block.

AIMS: Although electrocardiographic and echocardiographic findings with right ventricular (RV) pacing mimic intrinsic left bundle branch block (LBBB), left ventricular (LV) mechanical activation pattern may differ. We compared mechanical activation pattern of the LV in RV-pacing-induced LBBB with intrinsic LBBB in symptomatic chronic heart failure patients. METHODS AND RESULTS: We studied 37 patients with chronic RV-pacing and 37 patients with intrinsic LBBB who were referred for cardiac resynchronization therapy. Echocardiographic study including 2D speckle tracking longitudinal strain and M-mode were performed at baseline. Patients with intrinsic LBBB were younger, had higher prevalence of ischaemic heart disease, and had more severe depressed LV function. The basal-septal segments were the earliest activated sites in 11% of patients in RV-pacing-induced LBBB compared with 30% in intrinsic LBBB (P= 0.04). The mid- and basal-lateral segments were the latest activated sites in 57% of patients in RV-pacing-induced LBBB compared with 30% in intrinsic LBBB (P = 0.03). Left ventricular dyssynchrony, using longitudinal strain, time delay ≥ 130 ms between either mid-septal or apico-septal and either basal or mid-lateral segments was present in 71% of patients with RV-pacing-induced LBBB compared with 59% in intrinsic LBBB (P = 0.03). Using M-mode, LV dyssynchrony was present in 11% of patients with RV-pacing-induced LBBB compared with 59% in intrinsic LBBB (P = 0.02). CONCLUSION: Right ventricular-pacing results in less early basal activation and more often early mid-septal and late lateral wall activation in comparison with intrinsic LBBB. Imaging techniques that only visualize the basal- or mid-part of the LV may result in a serious underestimation of dyssynchrony in patients with pacing-induced LBBB.

Efficacy of multi-electrode duty-cycled radiofrequency ablation for pulmonary vein disconnection in patients with paroxysmal and persistent atrial fibrillation.

AIM: A novel multi-electrode pulmonary vein ablation catheter (PVAC) combining circular mapping and duty-cycled multi-electrode radiofrequency (RF) energy delivery has been developed to map and isolate the pulmonary veins (PVs). The aim of this study was to assess the efficacy of multi-electrode RF ablation using the PVAC device. METHODS AND RESULTS: A total of 102 consecutive patients, age 57.9 +/- 9.6 years, with paroxysmal or persistent drug refractory atrial fibrillation (AF) were referred for ablation. All patients had documented AF episodes with an AF duration of 9.3 +/- 7.5 years (range 1.5-25). The mean total procedure time was 139.30 +/- 37.72 (median 135, range 115-172). The mean fluoroscopy time required for PVAC ablation was 17 +/- 12 min (median 16, range 12-33) and the total fluoroscopy time was 32.1 +/- 11.3 min (median 29, range 25-39). The mean multi-electrode RF ablation time required to achieve complete PV isolation was 31 +/- 6.7 min (range 16-51). In eight patients with persistent AF, additional ablations were performed to defragment septal and posterior part of the left atrium. In five patients additional RF ablations using conventional catheters were necessary. After multi-electrode duty-cycled RF ablation, 62 of 102 (60.8%) patients were in sustained sinus rhythm without anti-arrhythmic drugs. The mean follow-up duration was 12.2 +/- 3.9 months (range 6-15). CONCLUSION: This novel multi-electrode ablation technique can be used for PV isolation and left atrium ablation with a relatively low medium-term success rate after the first ablation of approximately 61%. Larger studies with longer follow-up are required to evaluate the efficacy and whether multi-electrode RF ablation is associated with a different complication rate compared with standard PV isolation.

Pressure-volume loop analysis during implantation of biventricular pacemaker/cardiac resynchronization therapy device to optimize right and left ventricular pacing sites.

AIMS: To evaluate the clinical utility of pressure-volume loop analyses during pacemaker/implantable cardioverter defibrillator (ICD) implantations to assess the optimal right ventricular (RV) and/or left ventricular (LV) lead position. METHODS AND RESULTS: 29 patients with heart failure and chronic RV apical pacing were studied. Stroke work (SW), LV ejection fraction (LVEF), cardiac output (CO), and LV dP/dt(max) were assessed using a conductance catheter in the LV during RV apical, RV outflow tract, single-site LV, and biventricular pacing at different left-sided pacing locations. Left ventricular ejection fraction was 34.3 +/- 9.8%. Compared with baseline, RV outflow tract pacing showed a small increase of 4.0 +/- 6.4% in LV dP/dt(max) and no improvement in SW, LVEF, or CO. In the optimal biventricular configuration, SW increased 39 +/- 41%, LVEF increased 22 +/- 13%, CO increased 16 +/- 16%, and LV dP/dt(max) increased 10 +/- 11% (all P < 0.05). In 45% of the patients, the optimal LV lead position was found at a different location as the 'first choice' postero-lateral or lateral target vein. CONCLUSION: Pressure-volume loop analysis during pacemaker/ICD implantations facilitates to determine the optimal LV pacing site. Patients with chronic RV pacing showed a significant acute improvement in LV function when LV pacing or biventricular pacing is applied.

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).

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.

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.

Correction to: Arrhythmia-free survival and pulmonary vein reconnection patterns after second-generation cryoballoon and contact-force radiofrequency pulmonary vein isolation.

The name of the author Jaap Jan J. Smit was rendered wrongly in the original publication. The original article has been corrected.

Arrhythmia-free survival and pulmonary vein reconnection patterns after second-generation cryoballoon and contact-force radiofrequency pulmonary vein isolation.

INTRODUCTION: The aim of this study was to compare second-generation cryoballoon and contact-force radiofrequency point-by-point pulmonary vein isolation (PVI) in atrial fibrillation (AF) patients with regard to pulmonary vein reconnection and arrhythmia-free survival. METHODS AND RESULTS: Altogether, 269 consecutive patients with drug-refractory AF undergoing PVI were included and randomly allocated to second-generation cryoballoon or contact-force point-by-point radiofrequency ablation. Median follow-up duration was 389 days (interquartile range 219-599). Mean age was 59 years (71% male); 136 patients underwent cryoballoon and 133 patients underwent radiofrequency ablation. Acute electrical PVI was 100% for both techniques. Procedure duration was significantly shorter in cryoballoon vs radiofrequency (166.5 vs 184.13 min P = 0.016). Complication rates were similar (6.0 vs 6.7%, P = 1.00). Single procedure freedom of atrial arrhythmias was significantly higher in cryoballoon as compared to radiofrequency (75.2 vs 57.4%, P = 0.013). In multivariate analysis, persistent AF, AF duration, and cryoballoon ablation were associated with freedom of atrial tachyarrhythmias. The number of repeat ablation procedures was significantly lower in the cryoballoon compared to radiofrequency (15.0 vs 24.3%, P = 0.045). At repeat ablation, pulmonary vein reconnection rate was significantly lower after cryoballoon as compared to radiofrequency ablation (36.8 vs 58.1%, P = 0.003). CONCLUSIONS: Improved arrhythmia-free survival and more durable pulmonary vein isolation is seen after PVI using second-generation cryoballoon as compared to contact-force radiofrequency, in patients with drug-refractory paroxysmal AF. Complication rates for both ablation techniques are low.

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.

Treatment of atrial fibrillation in patients with enhanced sympathetic tone by pulmonary vein isolation or pulmonary vein isolation and renal artery denervation: clinical background and study design : The ASAF trial: ablation of sympathetic atrial fibrillation.

BACKGROUND: Hypertension is an important, modifiable risk factor for the development of atrial fibrillation (AF). Even after pulmonary vein isolation (PVI), 20-40% experience recurrent AF. Animal studies have shown that renal denervation (RDN) reduces AF inducibility. One clinical study with important limitations suggested that RDN additional to PVI could reduce recurrent AF. OBJECTIVE: The goal of this multicenter randomized controlled study is to investigate whether RDN added to PVI reduces AF recurrence. METHODS: The main end point is the time until first AF recurrence according to EHRA guidelines after a blanking period of 3 months. Assuming a 12-month accrual period and 12 months of follow-up, a power of 0.80, a two-sided alpha of 0.05 and an expected drop-out of 10% per group, 69 patients per group are required. We plan to randomize a total of 138 hypertensive patients with AF and signs of sympathetic overdrive in a 1:1 fashion. Patients should use at least two antihypertensive drugs. Sympathetic overdrive includes obesity, exercise-induced excessive blood pressure (BP) increase, significant white coat hypertension, hospital admission or fever induced AF, tachycardia induced AF and diabetes mellitus. The interventional group will undergo PVI + RDN and the control group will undergo PVI. RESULTS: Patients will have follow-up for 1 year, and continuous loop monitoring is advocated. CONCLUSION: This randomized, controlled study will elucidate if RDN on top of PVI reduces AF recurrence.