A novel strategy to treat vaso-vagal syncope: Cardiac neuromodulation by cryoballoon pulmonary vein isolation.

BACKGROUND: Clinical management of vaso-vagal syncope (VVS) remains challenging since no therapy has proven to completely prevent VVS recurrence. OBJECTIVE: The purpose of this study was to analyze the mid-term outcome of cryoballoon (CB) cardioneuroablation achieved by pulmonary vein isolation (PVI) in patients with VVS. METHODS: Patients who underwent CB cardioneuroablation in our centers between January 2014 to June 2018 were included. All patients had a history of VVS or pre-syncope despite therapeutic attempts with medical and/or pacing treatments. Patients were excluded in case of structural heart diseases, cerebrovascular diseases or suspected drug-related syncope. Both heart rate (HR) and atrio-ventricular (AV) interval were analyzed on the 12-lead electrocardiogram (ECG) the day before the procedure, the day after, and in the follow-up. RESULTS: In total, 26 patients (76.9% males, 37.5 ± 9.0 years old) were included. All patients underwent a successful procedure with the 28 mm second-generation Arctic Front Advance CB. No major complication occurred. At a mean follow-up of 20.1 ± 11.6 months the freedom from VVS or reflex pre-syncope was 83,7%, with 22 patients free from any clinical recurrence. Basal HR significantly increased the day after the procedure (57.2 bpm vs 78.3 bpm, p < 0.001), while at the final follow-up it stabilized at a value halfway between the 2 previous ones (69.8 bpm, p = 0.0086). The AV interval didn't modify significantly after the procedure. CONCLUSION: Endocardial autonomic denervation achieved by CB PVI appears to be an effective and safe treatment option for patients with refractory VVS and reflex pre-syncope.

Value of ultrasound for access guidance and detection of subclinical vascular complications in the setting of atrial fibrillation cryoballoon ablation.

AIMS: Vascular complications are the most common complications of atrial fibrillation (AF) ablation. Cryoballoon (CB) ablation for AF needs the insertion of a large 15 Fr sheath in the femoral vein. Our aim was to investigate the impact of vascular ultrasound (US) in guiding access and evaluating post-procedural subclinical complications in a large, multi-centre patient cohort that underwent CB ablation. METHODS AND RESULTS: A total cohort of 1435 consecutive patients were subdivided in 870 US -/-, 265 US -/+, and 300 US +/+ patients depending on US performance for: venipuncture guidance/post-procedural evaluation. Major clinical complications (requiring intervention and/or prolonged stay) were assessed. Irrespective of the clinical status, major US events were systematically determined in the subgroups with US evaluation 1 day post-procedure, if evidence of inadvertent artery puncture/cannulation (communication between artery and collection or artery-vein, regardless of the thrombosis state). Major clinical events were encountered in 1.7% (15/870), 1.1% (3/265), and 0% of patients in US -/-, US -/+, and US +/+ group, respectively (P = 0.02 between US -/- and US +/+ group). In the US -/- group, 5/10 (50%) of pseudo-aneurysms were diagnosed during readmission after a mean of 24 ± 11 days post-procedure. No delayed presentation was seen in the US -/+ group. Major US events during the US protocol post-procedure were seen in 3.8% (10/265) vs. 0.3% (1/300) of patients in US -/+ vs. US +/+ group, respectively, P = 0.004. CONCLUSION: US-guided venipuncture was associated with a near-to-zero risk of vascular complications in our patients undergoing CB ablation.

Over-the-needle trans-septal access using the cryoballoon delivery sheath and dilator in atrial fibrillation ablation.

BACKGROUND: In the setting of second-generation cryoballoon (CB2) ablation, left atrial (LA) access is generally achieved using a standard sheath (SS) that is exchanged for the 15Fr cryoballoon delivery sheath (CBS) and dilator over a long wire (CBS over-the-wire technique, CBS-W). Our objective was to evaluate the direct use of the CBS to gain LA access, by advancing the latter over the trans-septal needle (CBS over-the-needle technique, CBS-N), under transesophageal echocardiographic (TEE) guidance. METHODS: Consecutive patients who underwent CB2 ablation with the CBS-N technique were evaluated for feasibility of gaining LA access using TEE guidance and fluoroscopy views. Complications related to the LA access were compared with a matched CBS-W control group. Subanalysis (30 CBS-W vs 30 CBS-N patients) evaluated time-to-LA of the CBS: time from superior vena cava (with SS vs CBS) to LA insertion of the CBS, after exchange or directly, respectively. RESULTS: LA access could be achieved in all 505 patients of the CBS-N group, without technique modification or additional equipment. Challenging interatrial septa were noted in 13% of these patients: previous atrial septal defect repair (1%), hypermobile (10%), aneurysmal (1%), and abnormally thickened/fibrotic (1%). Incidence of complications was similar to the CBS-W group. Subanalysis showed a shorter time-to-LA in the CBS-N versus CBS-W group, 72 ± 46 seconds versus 293 ± 180 seconds, P < .001. CONCLUSIONS: Our study showed that the CBS-N technique is feasible and safe under echocardiographic guidance. Without sheath exchange, it simplifies the CB2 procedure, is less costly, time sparing, and might reduce the risk of air embolism.

Impact of cryoballoon-guided pulmonary vein isolation on non-invasive autonomic tests in patients with paroxysmal atrial fibrillation.

BACKGROUND: Pulmonary vein isolation (PVI) modulates the intrinsic cardiac autonomic nervous system (ANS). We evaluated the impact of PVI on 5 non-invasive autonomic tests. METHODS: Thirty patients (76% male, mean age 60.37 ±â€¯9.02 years) with paroxysmal atrial fibrillation (AF) underwent cryoballoon-guided PVI. Five autonomic tests were performed 24hrs before and after PVI (N = 30) and repeated after 6months (N = 22). Parasympathetic function was measured by heart rate (HR) variability during deep breathing (E/I ratio, I-E difference), Valsalva maneuver (Valsalva-ratio) and head-up tilt test (30/15 ratio). Sympathetic function was measured by systolic BP response to sustained handgrip and 10' tilting and by diastolic BP response to cold water. RESULTS: 24hrs after PVI, baseline HR increased from 57.93 ±â€¯9.06 bpm to 71.10 ±â€¯12.75 bpm (p < 0.001). At 6 months, baseline HR was lower than immediately post-PVI (62.59 ±â€¯7.89 vs 71.36 ±â€¯13.58 bpm, p = 0.032) but still higher in comparison to pre-PVI (62.59 ±â€¯7.89 vs 57.09 ±â€¯8.80 bpm, p < 0.001). No differences were seen in baseline BP and parasympathetic tests acutely and at 6months. Besides an acute lowering in systolic BP increase during handgrip test, all sympathetic tests remained unchanged. CONCLUSIONS: An acute HR increase attenuated at 6months and an acute lowered systolic BP response to sustained handgrip were the only changes after cryoballoon-guided PVI. Non-invasive autonomic tests seem therefore not appropriate to evaluate the autonomic modulatory effect of PVI, either due to a too limited sensitivity or a too localized effect of PVI to influence test results.

Complications of pulmonary vein isolation in atrial fibrillation: predictors and comparison between four different ablation techniques: Results from the MIddelheim PVI-registry.

Aims: To define predictors of complications of pulmonary vein isolation (PVI) and compare safety between different ablation techniques. Methods and results: One thousand patients with atrial fibrillation (AF) (age 60 ± 10, 72% males, CHA2DS2-VASc score 1 ± 1) underwent PVI using various techniques: conventional PVI (CPVI) using mapping with irrigated point-per-point RF ablation (n = 576), multi-electrode RF ablation with the pulmonary vein ablation catheter (PVAC) (n = 272) or high density mesh ablator (HDMA) (n = 59) and cryoballoon (CB) ablation (n = 93). A complication was defined as any procedure-related adverse event resulting in permanent injury or death, requiring intervention or treatment, or prolonging/requiring hospitalization for >48 h. A total of 105 (10.5%) complications occurred in 101 (10.1%) patients. No periprocedural death occurred. Most frequent complications were vascular complications (4%) and pericarditis (3.1%). Seven patients experienced permanent deficit due to PV stenosis (n = 3, 1 CPVI, 2 PVAC) (n = 3) and phrenic nerve palsy (PNP) (n = 4, 3 CPVI, 1 PVAC). Independent predictors of complications were female sex [odds ratio (OR) = 1.73; 95% confidence interval (CI) 1.08-2.79; P = 0.023], CHA2DS2-VASc score (OR = 1.24; 95% CI 1.01-1.52; P = 0.039), and ablation technique (P = 0.006) in multivariable-adjusted analysis. Among the different techniques, CB (P = 0.047) and PVAC ablation (P = 0.003) had lowest overall complication rates. Complication profile (type/severity) differed between techniques (association between CB and PNP, CPVI and pericardial injury, PVAC and transient ischaemic attack/PV stenosis). Conclusion: Overall complication rate of PVI with various techniques is 10.5%. Permanent deficit occurred only after PVAC and CPVI in 0.7% of patients. Female sex and a higher CHA2DS2-VASc score increase, while PVAC and CB-PVI decrease, overall risk. Differences in overall safety and individual complication profile make selection of the ablation technique in relation to clinical risk profile possible.

Clinical value of induction protocol after second generation cryoballoon ablation for paroxysmal atrial fibrillation.

Aims: The predictive value of induction studies after catheter ablation for atrial fibrillation (AF) is still debatable. To date, these studies have not been implemented in patients after cryoballoon (CB) ablation. Our aim was to analyse the clinical value of AF induction in patients treated by second generation CB for paroxysmal AF. Methods and results: Seventy patients underwent at first an isoproterenol challenge after pulmonary vein (PV) isolation to assess AF induction and early PV reconnections (EPVR). Patients without EPVR were evaluated for premature atrial contraction (PAC) induction; atrial ectopy was considered frequent (PAC+) if >1/10 cycles or >6/min. After restitution of baseline heart rate, rapid atrial pacing (RAP) was performed on all patients. AF induction by isoproterenol occurred only in 3/70 (4%) patients of whom 2/3 (66%) patients with an EPVR of a triggering vein. In the 62 patients without EPVR, PAC+ occurred in 17 patients (27%). RAP could induce AF in 23/70 (33%) patients. At a mean follow-up of 13.5 months, there were 11/70 (16%) AF recurrences. There was no significant difference in the AF recurrence rate between RAP inducible vs. non-inducible patients (log-rank P = 0.33). A 41% recurrence rate (7/17 patients) was seen in the PAC+ group with significantly different AF-free survival for PAC+ vs. PAC- patients (log rank P < 0.0001). PAC+ was the only independent determinant to predict AF recurrence after multivariate analysis. Conclusion: PAC occurrence in response to isoproterenol could predict AF recurrence after PV isolation by CB, while RAP showed no prognostic implication.

Phrenic nerve injury during right inferior pulmonary vein ablation with the second-generation cryoballoon: clinical, procedural, and anatomical characteristics.

Aims: There is still sparse information regarding phrenic nerve injury (PNI) during ablation of the right inferior pulmonary vein (RIPV) by means of the second-generation cryoballoon advance (CB-A). The aim of this study was to describe the procedural, anatomical, and clinical characteristics of patients who experienced PNI during the RIPV ablation. Methods and results: Consecutive patients who had undergone pulmonary vein isolation (PVI) using CB-A and suffered PNI during RIPV ablation were retrospectively included in our study. A cohort of patients who did not suffer any PNI was randomly included in a 1:3 ratio as a control group. The incidence of PNI during RIPV cryoapplication was 3.5%, (34 of 979 patients). There were no significant differences in clinical characteristics between patients with and without PNI. The prevalence of right common ostium (RCO) was significantly higher in patients with a PNI [4 patients (11.8%) vs. 1 patient (1.0%); P < 0.01]. A temperature drop velocity from the basal temperature to - 20 °C of 2.38 °C/s rendered a sensitivity of 82.4% and a specificity of 51.0% with a negative predictive value of 89.7%. Temperature drop velocity from basal to - 20 °C and the presence of an RCO were predictors of PNI in the multivariate analysis [odds ratio (OR) 7.27, 95% confidence interval (CI) 2.54-20.80; P < 0.01 and OR 18.41, 95%CI 1.87-181.23; P = 0.01, respectively). Conclusion: PNI during RIPV freeze might occur in around 3.5% of cases. The presence of an RCO and a fast temperature drop must prompt a careful monitoring of the phrenic nerve function during cryoapplications on the RIPV.

Acute and long-term outcomes of simultaneous atrioventricular node ablation and leadless pacemaker implantation.

AIMS: Leadless pacemaker (LDP) allows implantation using a femoral approach. This access could be utilized for conventional atrioventricular nodal ablation (AVNA). It could facilitate unifying the two procedural components. Data regarding its feasibility and long-term outcomes remain lacking. We aim to evaluate the feasibility and long-term outcomes of sequential LDP and AVNA. METHODS: Prospective, observational multicenter study including consecutive patients with indication for single-chamber pacemaker placement. In those with additional indication for AVNA, ablation was performed immediately after the LPD through the same sheath. RESULTS: A total of 137 patients were included. Mean age was 77.9 ± 10.5 years; 74 (54%) were men. Immediately following LDP implantation, 27 patients (19.7%) underwent concurrent AVNA. There were six (5.5%) complications in patients referred for LDP procedures and three (11%) in those who underwent a combined approach. None of these complications were solely attributable to the added AVNA component. No mechanical dislodgement, electrical damage to any device, or electromagnetic interference ever took place. During a mean follow-up period of 123 ± 48 days, three patients (3.6%) died of noncardiovascular causes. The remaining population stayed alive without significant arrhythmias. There were no relevant differences with regard to sensing and pacing thresholds between patients in the two groups. CONCLUSIONS: AVNA can safely be performed immediately following LDP. A combined approach obviates the need for additional vascular access and optimizes feasibility and comfort for patients and healthcare providers. It offers an acceptable safety and efficacy profile, both acutely and upon intermediate-term follow-up.

Efficacy and safety of the second generation cryoballoon ablation for the treatment of paroxysmal atrial fibrillation in patients over 75 years: a comparison with a younger cohort.

AIMS: In this double centre, retrospective study, we aimed to analyse the 1-year efficacy and safety of cryoballoon ablation (CB-A) in patients older than 75 years compared with those younger than 75-years old. METHODS AND RESULTS: Fifty-three consecutive patients aged 75 years or older with drug-resistant paroxysmal AF (PAF) who underwent pulmonary vein isolation (PVI) by the means of second generation CB-A, were compared with 106 patients aged <75 years. The mean age in the study group (>75 years) was 78.19 ± 2.7 years and 58.97 ± 8.5 in the control group. At 1-year follow-up the global success rate was 83.6% and did not significantly differ between older (10/53) and younger patients (16/106) (81.1 vs. 84.9%, P = 0.54). Transient phrenic nerve palsy was the most common complication which occurred in eight patients in the younger group and in three in the older group (7.5 vs. 5.7%, respectively, P = 0.66). CONCLUSIONS: The results of our study showed that CB-A for the treatment of PAF is a feasible and safe procedure in elderly patients, with similar success and complications rates when compared with a younger population.

Low rate of asymptomatic cerebral embolism and improved procedural efficiency with the novel pulmonary vein ablation catheter GOLD: results of the PRECISION GOLD trial.

AIMS: This prospective, multicentre study (PRECISION GOLD) evaluated the incidence of asymptomatic cerebral embolism (ACE) after pulmonary vein isolation (PVI) using a new gold multi-electrode radiofrequency (RF) ablation catheter, pulmonary vein ablation catheter (PVAC) GOLD. Also, procedural efficiency of PVAC GOLD was compared with ERACE. The ERACE study demonstrated that a low incidence of ACE can be achieved with a platinum multi-electrode RF catheter (PVAC) combined with procedural manoeuvres to reduce emboli. METHODS AND RESULTS: A total of 51 patients with paroxysmal atrial fibrillation (AF) (age 57 ± 9 years, CHA2DS2-VASc score 1.4 ± 1.4) underwent AF ablation with PVAC GOLD. Continuous oral anticoagulation using vitamin K antagonists, submerged catheter introduction, and heparinization (ACT ≥ 350 s prior to ablation) were applied. Cerebral magnetic resonance imaging (MRI) scans were performed within 48 h before and 16-72 h post-ablation. Cognitive function assessed by the Mini-Mental State Exam at baseline and 30 days post-ablation. New post-procedural ACE occurred in only 1 of 48 patients (2.1%) and was not detectable on MRI after 30 days. The average number of RF applications per patient to achieve PVI was lower in PRECISION GOLD (20.3 ± 10.0) than in ERACE (28.8 ± 16.1; P = 0.001). Further, PVAC GOLD ablations resulted in significantly fewer low-power (<3 W) ablations (15 vs. 23%, 5 vs. 10% and 2 vs. 7% in 4:1, 2:1, and 1:1 bipolar:unipolar energy modes, respectively). Mini-Mental State Exam was unchanged in all patients. CONCLUSION: Atrial fibrillation ablation with PVAC GOLD in combination with established embolic lowering manoeuvres results in a low incidence of ACE. Pulmonary vein ablation catheter GOLD demonstrates improved biophysical efficiency compared with platinum PVAC. TRIAL REGISTRATION: ClinicalTrials.gov NCT01767558.

Adding Electroanatomical Mapping to Cryoballoon Pulmonary Vein Isolation Improves 1-Year Clinical Outcome and Durability of Pulmonary Vein Isolation: A Propensity Score-Matched Analysis.

Background: Adding electroanatomical left atrial (LA) voltage mapping to cryoballoon ablation (CBA) improves validation of acute pulmonary vein isolation (PVI). Aims: To determine whether the addition of mapping can improve outcome and PVI durability. Methods: One-year outcome and PV reconnection (PVR) rate at first repeat ablation were studied in 400 AF patients in a propensity-matched analysis (age, AF type, CHA2DS2-VASc score) between Achieve catheter-guided CBA with additional EnSite LA voltage maps performed pre- and post-CBA (mapping group; N = 200) and CT- and Achieve catheter-guided CBA (control group; N = 200). Clinical success was defined as freedom of documented AF or atrial tachycardia (AT) > 30 s. PV reconnection patterns were characterized in repeat ablations. Results: At 1 year, 77 (19.25%) patients had recurrence of AF/AT, significantly lower than in the mapping group: 21 (10.5%) vs. 56 (28%), p < 0.001. Procedure time was shorter (72.2 ± 25.4 vs. 78.2 ± 29.3 min, p = 0.034) and radiation exposure lower (4465.0 ± 3454.6 Gy.cm2 vs. 5940.5 ± 4290.5 Gy.cm2, p = 0.037). Use of mapping was protective towards AF/AT recurrence (HR = 0.348; 95% CI 0.210-0.579; p < 0.001), independent of persistent AF type (HR = 1.723; 95% CI 1.034-2.872; p = 0.037), and LA diameter (HR = 1.055; 95% CI 1.015-1.096; p = 0.006). At repeat ablation (N = 90), persistent complete PVI was seen in 14/20 (70.0%) versus 23/70 (32.9%) in the mapping and conventional group, respectively (p = 0.03). Reconnection rate of the right inferior PV was lower with mapping (10.0% vs. 34,3%, p = 0.035). Conclusions: Adding electroanatomical LA voltage mapping to CBA improves 1-year clinical outcome and lowers both procedure time and radiation exposure. At repeat, use of mapping increases complete persistent PVI mainly by improving PVI durability of the RIPV.

Impact of radiofrequency characteristics on acute pulmonary vein reconnection and clinical outcome after PVAC ablation.

OBJECTIVE: The objective was to study the impact of radiofrequency (RF) characteristics on acute pulmonary vein reconnection (PVR) and outcome after PVAC ablation. PVI with additional ablation of PVR (PVI + PVR) was compared to PVI-only. METHODS: In 40 consecutive patients, after PVAC-guided PVI, adenosine and a 1-hour waiting time were used to unmask and ablate acute PVR (PVI + PVR group). RF-characteristics and 1-year AF freedom were compared post hoc to 40 clinically matched patients undergoing PVI only (PVI-only group). Custom-made software was used to assess RF characteristics of the PVAC applications needed to obtain baseline PVI. RESULTS: There was no difference in clinical characteristics or baseline RF-profile between both groups. Acute PVR was observed and ablated in 38 of 160 veins (24%). AF-freedom after PVI + PVR was higher than PVI (85% vs 65%, P < 0.05). Within the PVI group, comparing patients with and without AF-recurrence, the percentage of PVAC applications with high T° (>48°) but low power (<3W) was higher (28 ± 18% vs 11 ± 11%, P < 0.0001). Within the PVI + PVR group, when comparing PVs with and without PVR, the percentage of low power/high T° PVAC applications was also higher (27 ± 13% vs 13 ± 15%, P < 0.0001). CONCLUSIONS: (1) After PVAC ablation, 24% of PVs exhibit acute reconnection. Additional ablation of reconnection improves clinical outcome. (2) Acute reconnection as well as clinical recurrence of AF are characterized by PVAC ablation with a considerable number of applications with high temperature but low power. (3) If PV isolation is obtained with low power applications, a consistent use of both adenosine and waiting time is required.

Lessons from dissociated pulmonary vein potentials: entry block implies exit block.

AIMS: Prior reports using pacing manoeuvres, demonstrated an up to 42% prevalence of residual pulmonary vein to left atrium (PV-LA) exit conduction after apparent LA-PV entry block. We aimed to determine in a two-centre study the prevalence of residual PV-LA exit conduction in the presence of unambiguously proven entry block and without pacing manoeuvres. METHODS AND RESULTS: Of 378 patients, 132 (35%) exhibited spontaneous pulmonary vein (PV) potentials following circumferential PV isolation guided by three-dimensional mapping and a circular mapping catheter. Pulmonary vein automaticity was regarded as unambiguous proof of LA-PV entry block. We determined the prevalence of spontaneous exit conduction of the spontaneous PV potentials toward the LA. Pulmonary vein automaticity was observed in 171 PVs: 61 right superior PV, 33 right inferior PV, 47 left superior PV, and 30 left inferior PV. Cycle length of the PV automaticity was >1000 ms in all cases. Spontaneous PV-LA exit conduction was observed in one of 171 PVs (0.6%). In a subset of 69 PVs, pacing from within the PV invariably confirmed PVLA exit block. CONCLUSION: Unidirectional block at the LA-PV junction is unusual (0.6%). This observation is supportive of LA-PV entry block as a sufficient electrophysiological endpoint for PV isolation.

Impact of Diagnosis-to-Ablation Time on AF Recurrence: Pronounced the First 3 Years, Irrelevant Thereafter.

BACKGROUND: Diagnosis-to-ablation time (DAT) strongly predicts recurrence of atrial fibrillation (AF) after ablation. Whether this association holds with any lower and/or upper limits is unknown. OBJECTIVES: The goal of this study was to assess the impact of DAT on AF recurrence in search of lower and upper DAT thresholds. METHODS: A total of 2,000 patients with AF from 2 cohorts of 1,000 patients each (69% male; age 62 ± 10 years) undergoing pulmonary vein isolation (PVI) between 2005-2014 and 2017-2019 were followed up for 3 years. RESULTS: Clinical success was achieved in 61.7% of patients. Median DAT decreased over time from 36 months (Q1-Q3: 12-72 months) in the first cohort to 12 months (Q1-Q3: 5-48 months) in the second cohort (P < 0.001). A multivariable Cox proportional hazards fitted model of AF recurrence rate in relation to DAT (range: 0-288 months) showed a steep rise in AF recurrence, from 27% to 40% in the first 36 months (d%/dt = 0.36), with a first inflection point at 36 months, and a less steep rise to 45% until 90 months (d%/dt = 0.09), with flattening beyond 90 months (d%/dt = 0.026). Rise in AF recurrence rate in the first 36 months was higher in patients with persistent AF (from 40% to 54%; d%/dt = 0.39) than in patients with paroxysmal AF (19% to 29%; d%/dt = 0.28). CONCLUSIONS: The association between DAT and AF recurrence has no lower limit ("the shorter the better"), whereas little gain is to be expected beyond 36 months ("the longer the more irrelevant"). Our data advocate for performing PVI as early as possible, certainly within 3 years of AF diagnosis, and even more so in persistent AF.

An Unusual Case of Chronic Total Occlusion Secondary to Late-Diagnosed Recurrent Spontaneous Coronary Dissection.

We report a case of a male patient, aged 44 years, with a long history of percutaneous and surgical revascularizations, who presented with progressive effort angina and a "dynamic total occlusion" of the left circumflex coronary artery, which turned out to be an unrecognized spontaneous coronary artery dissection. In conclusion, spontaneous coronary artery dissection is a rare cause of acute coronary syndrome and it is even less frequent in male patients; therefore, a high level of suspicion, especially in the case of young patients without major cardiovascular risk factors, is mandatory for prompt diagnosis and adequate strategy. Our case highlights how a missed proper initial diagnosis can dramatically evolve. Furthermore, intravascular imaging can be crucial for confirming the diagnosis.

Electroanatomical mapping improves procedural outcomes of cryoballoon pulmonary vein isolation (the Achieve Plus study).

BACKGROUND: Validation of pulmonary vein (PV) isolation (PVI) using only the Achieve catheter following cryoballoon ablation (CBA) is imperfect since pulmonary vein potentials (PVP) can be recorded in only 50-85% of the veins and residual PVP are found in up to 4.3-7.6% of the isolated veins in remapping studies. OBJECTIVE: To study if addition of electroanatomical mapping to Achieve catheter-guided CBA is superior for PVI. METHODS: One hundred patients were randomized between Achieve catheter-guided CBA (control group; N = 50) and Achieve catheter-guided CBA with additional EnSite voltage maps performed pre- and post-CBA (Achieve Plus group; N = 50). Confirmation of PVI was done by circular mapping catheter (CMC) and EnSite mapping by a second blinded operator. RESULTS: Despite apparent PVI in all PVs after CBA, incomplete PVI was present in 0 out of 50 patients (0%) and 0 out of 204 PVs in the Achieve Plus group versus 6 patients out of 50 (12%; P = 0.012) and 6 out of 203 PVs (3%; P = 0.013) in the control group. All 6 non-isolated PVs could be successfully isolated by additional cryoapplications. Procedure time was longer in the Achieve Plus group (75.76 ± 21.65 vs 66.06 ± 16.83 min; P = 0.014) with equal fluoroscopy times (14.85 ± 6.41 vs 14.33 ± 8.55; P = 0.732). CONCLUSION: The addition of electroanatomical EnSite mapping to the Achieve catheter improves the PVI rate of CBA and could be considered for future use. Design and Results of the Achieve Plus study. The Achieve Plus study shows that the addition of electro-anatomical EnSite mapping to the Achieve catheter improves PVI rate of CBA and could be considered for future use. See text for further explanation. ABBREVIATIONS: CBA: cryoballoon ablation; PVI: pulmonary vein isolation.

Nurse-led care after ablation of atrial fibrillation: a randomized controlled trial.

AIMS: The added value of advanced practitioner nurse (APN) care after ablation of atrial fibrillation (AF) is unknown. The present study investigates the impact of APN-led care on AF recurrence, patient knowledge, lifestyle, and patient satisfaction. METHODS AND RESULTS: Sixty-five patients undergoing AF ablation were prospectively randomized to usual care (N = 33) or intervention (N = 32) group. In addition to usual care, the intervention consisted of an educational session, three consultations spread over 6 months and telephone accessibility coordinated by the APN. Primary outcome was the AF recurrence rate at 6-month follow-up. Secondary outcomes were lifestyle factors (alcohol intake, exercise, BMI, smoking), patient satisfaction and AF knowledge measured at 1 and 6 months between groups and within each group. Study demographics at 1 month were similar, except AF knowledge was higher in the intervention group (8.6 vs. 7, P = 0.001). At 6 months, AF recurrence was significantly lower in the intervention group (13.5 vs. 39.4%, P = 0.014). Between groups, patient satisfaction and AF knowledge were significantly higher in the intervention group, respectively, 9.4 vs. 8.7 (P < 0.001) and 8.6 vs. 7.0 out of 10 (P < 0.001). Within the intervention group, alcohol intake decreased from 3.9 to 2.6 units per week (P = 0.031) and physical activity increased from 224.4 ± 210.7 to 283.8 ± 169.3 (P = 0.048). No changes occurred within the usual care group. Assignment to the intervention group was the only protective factor for AF recurrence [Exp(B) 0.299, P = 0.04] in multivariable-adjusted analysis. CONCLUSION: Adding APN-led care after ablation of AF improves short-term clinical outcome, patient satisfaction and physical activity and decreases alcohol intake.

The present study investigates the added value of advanced practitioner nurse (APN)-led care consisting of an educational session, three consultations spread over 6 months and telephone accessibility coordinated by the APN in patients after ablation of atrial fibrillation (AF). Main findings are The addition of nurse-led care after ablation of AF improves short-term clinical outcome, patient satisfaction and physical activity and decreases alcohol intake.Our study shows that integrating nurse-led care in the post-AF ablation setting is a relatively simple to implement, low-cost intervention with a major impact on patient outcomes and quality of care. These findings encourage including nurse-led care into routine AF ablation follow-up.

An apparent way of achieving proof of pulmonary vein disconnection during cryoballoon ablation.

Pulmonary vein isolation (PVI) has established itself as a standard therapy for paroxysmal atrial fibrillation (AF). Still, the most widely performed procedure of point-by-point distal-tip ablation using a 3-dimensional mapping system and a circular catheter to validate PVI remains a complex, elaborative, and time-consuming procedure. This explains the many efforts being made over the recent years to simplify and shorten PVI procedures without compromising the efficacy or the safety. The cryoballoon (Ablation Frontiers, Medtronic, Inc., Minneapolis, MN, USA) is a recently introduced "single shot ablation tool" to facilitate PVI. Initial studies on efficacy and safety of this device are encouraging in patients with paroxysmal AF. However, several controversies remain, such as the need for an additional circular mapping catheter to validate PVI and the lack of on-line PV recording during freezes. One of the most recent developments in this field is the Achieve circular mapping catheter (Ablation Frontiers, Medtronic, Inc.). We describe an apparent case in which this tool is used in conjunction with the cryoballoon.

Delayed tamponade triggering Dressler's syndrome after pulmonary vein isolation.

Percutaneous catheter ablation is now a well-established, efficient and effective treatment strategy for recurrent, symptomatic atrial fibrillation (AF). Major complications though occur in up to 5.9% of procedures. New complications still continue to emerge. Delayed tamponade is only recently recognized as a major complication after ablation. We present a 68-year-old female patient who develops cardiac tamponade requiring pericardiocentesis 12 days after AF ablation. Subsequently, the tamponade triggers a Dressler syndrome with repetitive pleural effusions only adequately responsive to corticosteroids.

Sequelae after AF ablation: Efficacy and Safety go Hand in Hand.

Although nowadays performed on a routine basis, catheter ablation of atrial fibrillation is associated with the potential for major complications. Improving the safety remains therefore an important challenge. This article summarizes the different types of complications associated with AF ablation grouping them into clinically overt major complications, subclinical injury and permanent injury. Furthermore, it describes the potential predictors for complications and highlights the dynamic interplay between efficacy and safety.