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.

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.

Renal nerve stimulation: complete versus incomplete renal sympathetic denervation.

PURPOSE: Blood pressure (BP) reduction after renal sympathetic denervation (RDN) is highly variable. Renal nerve stimulation (RNS) can localize sympathetic nerves. The RNS trial aimed to investigate the medium-term BP-lowering effects of the use of RNS during RDN, and explore if RNS can check the completeness of the denervation. MATERIAL AND METHODS: Forty-four treatment-resistant hypertensive patients were included in the prospective, single-center RNS trial. The primary study endpoint was change in 24-h BP at 6- to 12-month follow-up after RDN. The secondary study endpoints were the acute procedural RNS-induced BP response before and after RDN; number of antihypertensive drugs at follow-up; and the correlation between the RNS-induced BP increase before versus after RDN (delta [Δ] RNS-induced BP). RESULTS: Before RDN, the RNS-induced systolic BP rise was 43(±21) mmHg, and decreased to 9(±12) mmHg after RDN (p < 0.001). Mean 24-h systolic/diastolic BP decreased from 147(±12)/82(±11) mmHg at baseline to 135(±11)/76(±10) mmHg (p < 0.001/<0.001) at follow-up (10 [6-12] months), with 1 antihypertensive drug less compared to baseline. The Δ RNS-induced BP and the 24-h BP decrease at follow-up were correlated for systolic (R = 0.44, p = 0.004) and diastolic (R = 0.48, p = 0.003) BP. Patients with ≤0 mmHg residual RNS-induced BP response after RDN had a significant lower mean 24-h systolic BP at follow-up compared to the patients with >0 mmHg residual RNS-induced BP response (126 ± 4 mmHg versus 135 ± 10 mmHg, p = 0.04). 83% of the patients with ≤0 mmHg residual RNS-induced BP response had normal 24-h BP at follow-up, compared to 33% in the patients with >0 mmHg residual RNS-induced BP response (p = 0.023). CONCLUSION: The use of RNS during RDN leads to clinically significant and sustained lowering of 24-h BP with fewer antihypertensive drugs at follow-up. RNS-induced BP changes were correlated with 24-h BP changes at follow-up. Moreover, patients with complete denervation had significant lower BP compared to the patients with incomplete denervation.

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.

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.

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.

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.

Renal nerve stimulation identifies aorticorenal innervation and prevents inadvertent ablation of vagal nerves during renal denervation.

PURPOSE: Recently we reported the use of renal nerve stimulation (RNS) during renal denervation (RDN) procedures. RNS induced changes in blood pressure (BP) and heart rate are not fully delineated yet. We hypothesized that electrical stimulation of the sympathetic nerve tissue in the renal artery would lead to an increase in BP and vagal stimulation would cause a decrease in BP. We report the different patterns of BP and heart rate responses elicited by RNS prior to RDN. METHODS: 35 patients with drug-resistant hypertension were included. RNS was performed under general anesthesia at four sites in the right and left renal arteries, both before and immediately after RDN. RNS-induced BP and heart rate changes were monitored. RESULTS: A total of 289 RNS sites in 35 patients were analyzed. An increase in systolic BP of >10 mmHg was regarded as a positive BP response to RNS. This pattern of response was observed in 180 sites (62%). 86 RNS sites (30%) showed an indifferent response with BP changes ≤10 mmHg. At 13 sites (4.5%) RNS elicited a decrease in BP up to -8 mmHg. However, 10 RNS sites (3.5%) showed a pronounced vagal response with hypotension and sinus cycle lengths ranging between 4224-10272 milliseconds. These sites were distributed among two patients. CONCLUSION: RNS identified sympathetic and parasympathetic nerve tissue in the renal arteries. RNS can be potentially used to map nerve bundles and guide selective ablation of sympathetic nerve fibers and prevent inadvertent ablation of parasympathetic nerve tissue during RDN.

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.

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.

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.

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.

Experimental, Pathologic, and Clinical Findings of Radiofrequency Catheter Ablation of Para-Hisian Region From the Right Ventricle in Dogs and Humans.

BACKGROUND: Ablation of para-Hisian accessory pathway (AP) poses high risks of atrioventricular block. We developed a pacing technique to differentiate the near-field (NF) from far-field His activations to avoid the complication. METHODS AND RESULTS: Three-dimensional mapping of the right ventricle was performed in 15 mongrel dogs and 23 patients with para-Hisian AP. Using different pacing outputs, the NF- and far-field His activation was identified on the ventricular aspect. Radiofrequency application was delivered at the NF His site in 8 (group 1) and the far-field His site in 7 dogs (group 2), followed by pathologic examination after 14 days. NF His activation was captured with 5 mA/1 ms in 10 and 10 mA/1 ms in 5 dogs. In group 1, radiofrequency delivery resulted in complete atrioventricular block in 3, right bundle branch block with HV (His-to-ventricular) interval prolongation in 1, and only right bundle branch block in 2 dogs, whereas no changes occurred in group 2. Pathologic examination in group-1 dogs showed complete or partial necrosis of the His bundle in 4 and complete necrosis of the right bundle branch in 5 dogs. In group 2, partial necrosis in the right bundle branch was found only in 1 dog. Using this pacing technique, the APs were 5.7±1.2 mm away from the His bundle located superiorly in 20 or inferiorly in 3 patients. All APs were successfully eliminated with 1 to 3 radiofrequency applications. No complications and recurrence occurred during a follow-up of 11.8±1.4 months. CONCLUSIONS: Differentiating the NF His from far-field His activations led to a high ablation success without atrioventricular block in para-Hisian AP patients.

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.

Renal vascular calcification and response to renal nerve denervation in resistant hypertension.

Renal sympathetic nerve denervation (RDN) is accepted as a treatment option for patients with resistant hypertension. However, results on decline in ambulatory blood pressure (BP) measurement (ABPM) are conflicting. The high rate of nonresponders may be related to increased systemic vascular stiffness rather than sympathetic overdrive. A single center, prospective registry including 26 patients with treatment resistant hypertension who underwent RDN at the Isala Hospital in the Netherlands. Renal perivascular calcium scores were obtained from noncontrast computed tomography scans. Patients were divided into 3 groups based on their calcium scores (group I: low 0-50, group II: intermediate 50-1000, and group III: high >1000). The primary end point was change in 24-hour ABPM at 6 months follow-up post-RDN compared to baseline. Seven patients had low calcium scores (group I), 13 patients intermediate (group II), and 6 patients had high calcium scores (group III). The groups differed significantly at baseline in age and baseline diastolic 24-hour ABPM. At 6-month follow-up, no difference in 24-hour systolic ABPM response was observed between the 3 groups; a systolic ABPM decline of respectively -9 ±â€Š12, -6 ±â€Š12, -12 ±â€Š10 mm Hg was found. Also the decline in diastolic ambulatory and office systolic and diastolic BP was not significantly different between the 3 groups at follow-up. Our preliminary data showed that the extent of renal perivascular calcification is not associated with the ABPM response to RDN in patients with resistant hypertension.