Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program.

BACKGROUND: The randomized, sham-controlled RADIANCE-HTN (A Study of the Recor Medical Paradise System in Clinical Hypertension) SOLO, RADIANCE-HTN TRIO, and RADIANCE II (A Study of the Recor Medical Paradise System in Stage II Hypertension) trials independently met their primary end point of a greater reduction in daytime ambulatory systolic blood pressure (SBP) 2 months after ultrasound renal denervation (uRDN) in patients with hypertension. To characterize the longer-term effectiveness and safety of uRDN versus sham at 6 months, after the blinded addition of antihypertensive treatments (AHTs), we pooled individual patient data across these 3 similarly designed trials. METHODS: Patients with mild to moderate hypertension who were not on AHT or with hypertension resistant to a standardized combination triple AHT were randomized to uRDN (n=293) versus sham (n=213); they were to remain off of added AHT throughout 2 months of follow-up unless specified blood pressure (BP) criteria were exceeded. In each trial, if monthly home BP was ≥135/85 mm Hg from 2 to 5 months, standardized AHT was sequentially added to target home BP <135/85 mm Hg under blinding to initial treatment assignment. Six-month outcomes included baseline- and AHT-adjusted change in daytime ambulatory, home, and office SBP; change in AHT; and safety. Linear mixed regression models using all BP measurements and change in AHT from baseline through 6 months were used. RESULTS: Patients (70% men) were 54.1±9.3 years of age with a baseline daytime ambulatory/home/office SBP of 150.5±9.8/151.0±12.4/155.5±14.4 mm Hg, respectively. From 2 to 6 months, BP decreased in both groups with AHT titration, but fewer uRDN patients were prescribed AHT (P=0.004), and fewer additional AHT were prescribed to uRDN patients versus sham patients (P=0.001). Whereas the unadjusted between-group difference in daytime ambulatory SBP was similar at 6 months, the baseline and medication-adjusted between-group difference at 6 months was -3.0 mm Hg (95% CI, -5.7, -0.2; P=0.033), in favor of uRDN+AHT. For home and office SBP, the adjusted between-group differences in favor of uRDN+AHT over 6 months were -5.4 mm Hg (-6.8, -4.0; P<0.001) and -5.2 mm Hg (-7.1, -3.3; P<0.001), respectively. There was no heterogeneity between trials. Safety outcomes were few and did not differ between groups. CONCLUSIONS: This individual patient-data analysis of 506 patients included in the RADIANCE trials demonstrates the maintenance of BP-lowering efficacy of uRDN versus sham at 6 months, with fewer added AHTs. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02649426 and NCT03614260.

Catheter-related and clinical complications associated with QDOT MICROTM Ablation Catheter.

INTRODUCTION: The QDOT MICROTM Ablation Catheter is a next-generation ablation catheter that allows for high-power ablation up to 90 watts. METHODS: We aimed to assess AE associated with the QDOT MICROTM catheter using the MAUDE database. A MAUDE database search was conducted on May 25, 2024, to capture all AEs (since FDA approval) associated with this ablation catheter. RESULTS: A total of 302 AEs from November 23, 2022, to April 30, 2024, were reported including 148 (49%) catheter-related issues and 154 (51%) clinical complications. Among the catheter-related issues, physical catheter damage (74.3%, n = 110) was most common, followed by communication or display issue (10.8%, n = 16), irrigation issue (9.5%, n = 14), signal issue or artifact (3.4%, n = 5), and inaccurate temperature measurement (2.0%, n = 3). Regarding clinical complications, the most common AE was pericardial effusion (43.5%, n = 67), followed by char formation (11.7%, n = 18), catheter thrombosis (7.1%, n = 11), stroke (7.1%, n = 11), pericarditis (7.1%, n = 11), esophageal complications (6.5%, n = 10), phrenic nerve palsy (3.9%, n = 6), cardiac arrest (3.9%, n = 6), significant AV block (3.9%, n = 6), pulmonary vein stenosis (3.2%, n = 5), coronary artery spasm (1.3%, n = 2), and pulmonary embolism (0.6%, n = 1). There were 11 deaths (five related to esophageal complications, five related to cardiac arrest, and one related to pericardial effusion with cardiac tamponade). CONCLUSION: As high-power ablation strategy with novel ablation catheters is becoming more widely utilized, operators must be aware of potential catheter-related issues and clinical complications that may arise. More data are needed to further evaluate risks of these complications to improve the catheter's safety and efficacy.

Half-normal saline versus normal saline for irrigation of open-irrigated radiofrequency catheters in atrial fibrillation ablation.

BACKGROUND: The creation of effective and permanent lesions is a crucial factor in determining the success rate of atrial fibrillation (AF) ablation. By increasing the efficacy of radiofrequency (RF) energy-mediated lesion formation, half-normal saline (HNS) as an irrigant for open-irrigated ablation catheters has the potential to reduce procedural times and improve acute and long-term outcomes. METHODS: This is a double-blind randomized clinical trial of 99 patients undergoing first-time RF catheter ablation for AF. Patients enrolled were randomly assigned in a 1:1 fashion to perform ablation using HNS or normal saline (NS) as an irrigant for the ablation catheter. RESULTS: The use of HNS is associated with shorter RF times (26 vs. 33 min; p = .02) with comparable procedure times (104 vs. 104 min). The rate of acute pulmonary vein reconnections (16% vs. 18%) was comparable, with a median of 1 vein reconnection in the HNS arm versus 2 in the NS arm. There was no difference in procedure-related complications, including the incidence of postprocedural hyponatremia when using HNS. Over the 1-year follow-up, there is no significant difference between the HNS and NS with respect to the recurrence of any atrial arrhythmia (off antiarrhythmic drugs [AAD]: 47% vs. 52%; hazard ratio [HR]: 1.17, 95% confidence interval [CI]: 0.66-2.06; off/on AAD: 66% vs. 66%, HR: 1.06, 95% CI: 0.53-2.12), with a potential benefit of using HNS when considering the paroxysmal AF cohort (on/off AAD 73% vs. 62%, HR: 0.72, 95% CI: 0.19-2.70). CONCLUSIONS: In a mixed cohort of patients undergoing first-time AF ablation, irrigation of open-irrigated RF ablation catheters with HNS is associated with shorter RF times, with a comparably low rate of procedure-related complications. In the long term, there is no significant difference with respect to the recurrence of any atrial arrhythmia. Larger studies with a more homogeneous population are necessary to determine whether HNS improves clinical outcomes.

Incidence of ablation-induced esophageal injury associated with high-power short duration temperature-controlled pulmonary vein isolation using a specialized open-irrigated ablation catheter: A retrospective single-center study.

INTRODUCTION: To evaluate short-term efficacy and incidence of ablation-induced endoscopically detected esophageal injury in patients undergoing high-power, short-duration (HPSD) pulmonary vein isolation using a novel irrigated radiofrequency ablation catheter and ablation generator setup. METHODS AND RESULTS: Atrial fibrillation (AF) patients, who underwent AF ablation using an irrigated radiofrequency ablation catheter specifically designed for a HPSD ablation approach (50 W, with a target Ablation Index of 350 at posterior wall), received postablation esophageal endoscopy after ablation. In total 45 consecutive patients (67 ± 10 years; 58% male; 42% paroxysmal AF) undergoing AF ablation using a specialized ablation catheter (QDOT) were included in the study. Thirty-one of 45 patients (69%) underwent a first-time pulmonary vein isolation (Group 1, 67 ± 11 years; 55% male; 48% paroxysmal AF). Fourteen patients (31%) underwent a redo AF procedure (Group 2, 66 ± 8 years; 64% male; 29% paroxysmal AF). Patients undergoing first-time pulmonary vein isolation were included in the final analysis. In these patients an endoscopically detected esophageal lesion (EDEL) was detected in 5 of 31 (16%) patients (erosion n = 2, ulcer n = 3). Mean contact force at posterior wall ablation sites was significantly lower in patients with postprocedural EDEL compared with patients without EDEL (11.9 ± 0.8 g vs. 15.6 ± 4.7 g). CONCLUSION: PVI using a specialized high-power ablation catheter in conjunction with a HPSD ablation approach results in a 16% incidence of EDEL in first AF ablation candidates. Future studies evaluating high-power short duration ablation strategies should include esophageal endoscopy to estimate the risk of clinically relevant esophageal complications.

Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control After Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial.

BACKGROUND: The multicenter, international, randomized, blinded, sham-controlled RADIANCE-HTN SOLO trial (A Study of the ReCor Medical Paradise System in Clinical Hypertension) demonstrated a 6.3 mm Hg greater reduction in daytime ambulatory systolic blood pressure (BP) at 2 months by endovascular ultrasound renal denervation (RDN) compared with a sham procedure among patients not treated with antihypertensive medications. We report 6-month results after the addition of a recommended standardized stepped-care antihypertensive treatment to the randomized endovascular procedure under continued blinding to initial treatment. METHODS: Patients with a daytime ambulatory BP ≥135/85 mm Hg and <170/105 mm Hg after a 4-week discontinuation of up to 2 antihypertensive medications, and a suitable renal artery anatomy, were randomized to RDN (n=74) or sham (n=72). Patients were to remain off antihypertensive medications throughout the first 2 months of follow-up unless safety BP criteria were exceeded. Between 2 and 5 months, if monthly measured home BP was ≥135/85 mm Hg, a standardized stepped-care antihypertensive treatment was recommended consisting of the sequential addition of amlodipine (5 mg/d), a standard dose of an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and hydrochlorothiazide (12.5 mg/d), followed by the sequential uptitration of hydrochlorothiazide (25 mg/d) and amlodipine (10 mg/d). Outcomes included the 6-month (1) change in daytime ambulatory systolic BP adjusted for medications and baseline systolic BP, (2) medication burden, and (3) safety. RESULTS: A total of 69/74 RDN patients and 71/72 sham patients completed the 6-month ambulatory BP measurement. At 6 months, 65.2% of patients in the RDN group were treated with the standardized stepped-care antihypertensive treatment versus 84.5% in the sham group (P=0.008), and the average number of antihypertensive medications and defined daily dose were less in the RDN group than in the sham group (0.9±0.9 versus 1.3±0.9, P=0.010 and 1.4±1.5 versus 2.0±1.8, P=0.018; respectively). Despite less intensive standardized stepped-care antihypertensive treatment, RDN reduced daytime ambulatory systolic BP to a greater extent than sham (-18.1±12.2 versus -15.6±13.2 mm Hg, respectively; difference adjusted for baseline BP and number of medications: -4.3 mm Hg, 95% confidence interval, -7.9 to -0.6, P=0.024). There were no major adverse events in either group through 6 months. CONCLUSIONS: The BP-lowering effect of endovascular ultrasound RDN was maintained at 6 months with less prescribed antihypertensive medications compared with a sham control. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT02649426.

Impact of epicardial adipose tissue and catheter ablation strategy on biophysical parameters and ablation lesion characteristics.

BACKGROUND: Epicardial adipose (EA) tissue may limit effective radiofrequency ablation (RFA). OBJECTIVES: We sought to evaluate the lesion formation of different ablation strategies on ventricular myocardium with overlying EA. METHODS: Bovine myocardium with EA was placed in a circulating saline bath in an ex vivo model. Open-irrigated (OI) RFA was performed, parallel to the myocardium, over fat at 50 W for variable RF durations, variable contact force, catheter configurations (unipolar RF vs bipolar RF), and catheter irrigants (normal saline vs half-normal saline). Ablation was also performed with a needle-tipped ablation catheter (NTAC), perpendicular to the myocardium. RESULTS: Increasingly thick EA attenuated lesion size regardless of ablation strategy. RF applied with longer durations and increasing CF produced larger lesion volumes and deeper lesions with ablation over EA more than 3 mm but was unable to produce measurable lesions when EA less than 3 mm. Similarly, ablation with half normal saline irrigant created slightly deeper lesions than bipolar RF and unipolar RF with normal saline as EA thickness increased, but was unable to produce measurable lesions when EA more than 3 mm. Of all ablation strategies, only NTAC produced effective lesion volumes when ablating over thick (>3 mm) EA. CONCLUSIONS: While EA attenuates lesion depth and size, relatively larger, and deeper lesions can be achieved with longer RFA duration, higher CF, half normal saline irrigant, and, to a greater extent, by utilizing bipolar RF or NTAC, but only over thin adipose (<3 mm). Of those catheters/strategies tested, only NTAC was able to effectively deliver RF over thick (>3 mm) EA with this model.

Larger and deeper ventricular lesions using a novel expandable spherical monopolar irrigated radiofrequency ablation catheter.

BACKGROUND: Radiofrequency (RF) ablation is an established treatment for ventricular tachycardia (VT). However, the inability of current RF catheters to address deep or large substrate may explain most of the clinical failures. OBJECTIVES: The aim of this study is to assess the efficacy and safety of ablation in the left ventricle (LV) in sheep using a novel 8-Fr deflectable ablation catheter (Sphere-9; Affera, Inc) with a 9-mm expandable spherical monopolar irrigated RF tip vs a standard RF irrigated catheter (Biosense Webster, Diamond Bar, CA). The impact on tissue was assessed on local bipolar electrograms (from nine uniformly distributed mini surface electrodes and an internal central reference electrode), as well as on direct lesion measurement post mortem. METHODS AND RESULTS: Eleven sheep underwent LV endocardial ablation in healthy tissue using the Sphere-9 catheter (n = 6), or a conventional irrigated RF catheter (n = 5). Twenty lesions were created with the Sphere-9 (current limit: 2.7 A; temp. limit: 60°C; irrigation: 30 mL/min; and duration: 60-120 seconds). Local bipolar electrograms at the surface of the catheter disappeared during RF delivery in 17 of 20 (85%) lesions. The mean lesion volume was 1707 ± 771 mm 3 (length: 15.8 ± 3.3 mm; width: 11.6 ± 4.2 mm; and depth: 10.3 ± 2.9 mm). Twenty-five lesions were created with a standard RF irrigated catheter (power control 35 W; irrigation: 30 mL/min; duration: 60 seconds; volume 537 ± 398 mm 3 ; length: 8.2 ± 2.3 mm; width: 5.2 ± 1.8 mm; and depth: 5.5 ± 2.4 mm). The novel spherical RF catheter created significantly larger lesions ( P < .001 for measurements in all dimensions). There were no steam pops with the novel ablation catheter vs one with the conventional catheter. CONCLUSIONS: This novel spherical monopolar irrigated RF catheter creates lesions that are twice as large and deep as a standard irrigated RF catheter.

Transvenous retrograde reposition of an atrial lead.

Pacemaker lead dislodgement is one of the most undesired complications of pacemaker implantation. Repeated procedures are associated with an increased risk of complications, such as pocket infection, pneumothorax, and hematoma. We present a case who experienced dislodgement of the atrial pacemaker lead of a cardiac resynchronization therapy with defibrillator implantation device, which was corrected using a steerable ablation catheter by the transfemoral route.

Development, safety and efficacy of a novel circular-irrigated deca-channel mapping and ablation catheter for pulmonary vein isolation.

BACKGROUND: Pulmonary vein isolation (PVI), a cornerstone for catheter ablation of atrial fibrillation (AF), remains a complex and time-consuming procedure. Present study introduces a novel, circular-irrigated, deca-channel mapping and ablation catheter (CIDMA), describes the in vitro test results on feasibility, safety, and acute efficacy of the CIDMA catheter. METHODS: An assembled CIDMA catheter was subjected to a number of in vitro tests. With this catheter, ablation procedures were first performed in a pig's myocardial strips in vitro to determine the effects in unipolar or bipolar configuration. RESULTS: Three catheters were assembled. The adjustable circular diameter was changed from initial state of 32.41 ± 0.61 mm into controlled state of 28.61 ± 0.47 mm (P = 0.013). In the plastic model, the push-ability, torque-ability, and kink resistance of CIDMA catheter were shown to be satisfactory. In vitro, our findings showed that ablation could produce obvious ablation lesions, and unipolar ablation (at length, width and depth of 5.0 ± 1.3, 4.6 ± 0.7, and 4.2 ± 0.6 mm, respectively) was more effective than bipolar (at length, width and depth of 2.8 ± 0.2, 4.2 ± 0.5, and 2.3 ± 0.4 mm, respectively) (P < 0.01). CONCLUSIONS: In vitro, our preliminary data suggest that the CIDMA catheter produced optimal ablation lesions, especially in the unipolar ablation mode. Future in vivo animal and clinical studies are warranted to test the efficacy of this catheter in real-world scenario.

Entrapment of "PV-Tracker" guidewire in the pulmonary veins during atrial fibrillation ablation with PVAC Gold.

We report the entrapment of Pulmonary Vein Ablation Catheter (Medtronic, Minneapolis, MN, USA) and its guidewire within the right pulmonary veins in two patients. The catheters could be retrieved without complications but they were disabled in both cases. This nondescribed incident should be recognized by PVAC users since it may be a source of potential severe complications during pulmonary vein isolation procedures.

Sinus Node and Atrial Arrhythmias.

Although sinus node dysfunction (SND) and atrial arrhythmias frequently coexist and interact, the putative mechanism linking the 2 remain unclear. Although SND is accompanied by atrial myocardial structural changes in the right atrium, atrial fibrillation (AF) is a disease of variable interactions between left atrial triggers and substrate most commonly of left atrial origin. Significant advances have been made in our understanding of the genetic and pathophysiologic mechanism underlying the development and progression of SND and AF. Although some patients manifest SND as a result of electric remodeling induced by periods of AF, others develop progressive atrial structural remodeling that gives rise to both conditions together. The treatment strategy will thus vary according to the predominant disease phenotype. Although catheter ablation will benefit patients with predominantly AF and secondary SND, cardiac pacing may be the mainstay of therapy for patients with predominant fibrotic atrial cardiomyopathy. This contemporary review summarizes current knowledge on sinus node pathophysiology with the broader goal of yielding insights into the complex relationship between sinus node disease and atrial arrhythmias.

Importance of anticoagulation and postablation silent cerebral lesions: Subanalyses of REVOLUTION and reMARQable studies.

BACKGROUND: Silent cerebral lesions (SCLs) are a potential complication of left atrial radiofrequency ablation (RFA) procedures for paroxysmal atrial fibrillation (PAF). We aimed to compare the incidence of SCLs in patients treated with irrigated RFA multielectrode catheters (nMARQ® Catheter group) and irrigated focal RFA catheters (NAVISTAR® THERMOCOOL® Catheter; TC group) after PAF ablation from subpopulation neurological assessment (SNA) cohorts of the REVOLUTION and reMARQable studies. METHODS: Data from SNA cohorts in the prospective, nonrandomized REVOLUTION study (March 2011-September 2013) and the prospective, randomized, controlled reMARQable study (October 2013-November 2015) were included. The incidence of SCLs was assessed pre- and postablation using magnetic resonance imaging. Neurological deficits were assessed using the National Institutes of Health Stroke Scale, modified Rankin Scale, and Montreal Cognitive Assessment. RESULTS: A total of 37 patients from REVOLUTION and 76 patients from reMARQable were included in the SNA cohort of each study. In the REVOLUTION SNA cohort, the incidence of SCLs was 21.1% (4/19) in the nMARQ® Catheter group and 5.9% (1/17) in the TC group. Findings from REVOLUTION helped inform the reMARQable study protocol's stringent anticoagulation regimen. SCL incidence was subsequently reduced in both groups (nMARQ® Catheter, 7.9%; TC, 3.3%). No permanent neurological deficits were observed. CONCLUSION: Adherence to a stringent anticoagulation regimen prior to and during ablation procedures appears to be an important factor in minimizing the risk of SCL.

[Study of New Micropore RF system on Lesion Formation and Complications].

OBJECTIVES: To study the safety and effectiveness of a new type of micropore ablation catheter in vitro ablation system, and to provide reference for clinical practice. METHODS: To evaluate two kinds of catheter in cardiac tissue ablation depth, tissue temperature and thrombosis situation by the same RF system. RESULTS: The power set 25 W, There was no significant difference in ablation depth between the two groups, and no Pop and thrombosis occurred. When the power is more than 40 W, two groups occurred more Pop and thrombosis. CONCLUSIONS: When using high power for Cardiac RF ablation, doctors should pay more attention to complications and thrombosis.

Characteristics of Cavotricuspid Isthmus Ablation for Atrial Flutter Guided by Novel Parameters Using a Contact Force Catheter.

INTRODUCTION: This study sought to investigate specific contact force (CF) parameters to guide cavotricuspid isthmus (CTI) ablation and compare the outcome with a historical control cohort. METHODS AND RESULTS: Patients (30) undergoing CTI ablation were enrolled prospectively in the Study cohort and compared with a retrospective Control cohort of 30 patients. Ablation in the Study cohort was performed using CF parameters >10 g and <40 g and a Force Time Integral (FTI) of 800 ± 10 g. The Control cohort underwent traditionally guided CTI ablation. Traditional parameters (electrogram and impedance change) were assessed in both cohorts. All ablations regardless of achieving targets were included in data analysis. Bidirectional CTI block was achieved in all of the Study and 27 of the Control cohort. Atrial flutter recurred in 3 (10%) patients (follow-up 564 ± 212 days) in the study cohort and in 3 (10%) patients (follow-up 804 ± 540 days) in the Control cohort. There were no major complications in either cohort. Traditional parameters correlated poorly with CF parameters. In the Study cohort, flutter recurrence was associated with significantly lower FTI and ablation duration, but was not associated with total average CF. CONCLUSION: CTI ablation can be safely performed using CF parameters guiding ablation, with similar long-term results to a historical ablation control group. Potentially CF parameters may provide adjunctive information to enable a more efficient CTI ablation. Further research is required to confirm this.

Acute safety and efficacy of a novel multipolar irrigated radiofrequency ablation catheter for pulmonary vein isolation.

INTRODUCTION: "Single shot" ablation devices to treat symptomatic atrial fibrillation have been engineered over the last years. Safety and efficacy also includes subclinical complications only detected with esophageal endoscopy or cerebral MRI in asymptomatic patients. We studied the acute efficacy and safety profile of a novel multipolar irrigated RF ablation catheter (nMARQ™). METHODS AND RESULTS: Forty-three patients underwent pulmonary vein isolation (PVI) using the novel ablation device. Patient baseline and procedural characteristics were documented. Efficacy of PVI was identified using only the nMARQ™ catheter. All patients underwent postablation endoscopic evaluation of the esophagus to document thermal damage and cerebral MRI (diffusion weight imaging, attenuated diffusion coefficient-map) to document incidence and number of silent cerebral lesions (SCL). Effective PVI was achieved in 98% of targeted PVs in a mean procedure time of 133 minutes. A mean of 4.8, 60-second RF applications, per PV was needed for effective PVI. No clinical procedure-associated complications were noted. Esophageal temperature increase >40.5 °C was noted in 22 (51%) patients and 14 of these had thermal esophageal lesions on endoscopic evaluation. A total of 26 SCLs were noted in 14 patients (33%; 1.9/patient; mean diameter of 2.3 mm, 88% of lesions were ≤3 mm). CONCLUSIONS: PVI using the novel irrigated RF multipolar ablation device (nMARQ™) appears to be acutely effective. No clinical complications were identified. A high incidence of SCL (33%) and thermal esophageal lesions (33%) bears caution and further studies on long-term efficacy and safety are needed.

Duty-cycled multi-electrode radiofrequency vs. conventional irrigated point-by-point radiofrequency ablation for recurrent atrial fibrillation: comparative 3-year data.

AIMS: Pulmonary vein isolation (PVI) is an accepted treatment to relieve symptoms in patients with atrial fibrillation (AF). We studied 3 year outcome after PVI guided by duty-cycled multi-electrode radiofrequency (RF) ablation (pulmonary vein ablation catheter, PVAC) and provided comparative data to outcome after conventional PVI (CPVI) using mapping with irrigated, point-per-point RF ablation. METHODS AND RESULTS: One hundred and sixty-one consecutive patients with symptomatic paroxysmal or persistent AF and minimal heart disease underwent PVI (PVAC, n = 79 vs. CPVI, n = 82). Follow-up (with symptom-guided rhythm monitoring) was truncated at 3 years in all patients. Success was defined as freedom of documented arrhythmia after a single procedure and without antiarrhythmic drug treatment (ADT). Baseline characteristics did not differ between both groups. At 3 years follow-up, single-procedure success without ADT was comparable between PVAC and CPVI (65% vs. 55%, P = NS). The majority of recurrences occurred during the first year (PVAC 79% vs. CPVI 70%, P = NS). The annual rate of very late recurrence (i.e. beyond 1 year) was similar in both groups (10.5% vs. 15%, P = NS). CONCLUSION: At 3 years follow-up, outcome after PVAC-guided PVI is comparable to conventional isolation by irrigated point-by-point RF ablation. In both strategies, the majority of recurrences occurred in the first year of ablation.

Unique Extraction of a Fractured Pacemaker Lead Adhered to the Spermatic Vein.

Transvenous lead extraction has been increasingly recognized as a safe and effective method of lead extraction, but there are only few references for extracting leads migrating outside the heart. We present a successful extraction of a fractured pacemaker lead from the spermatic vein using several approaches and multiple tools.

"Honey pot"-like lesion formation: Impact of catheter contact angle on lesion formation by novel diamond-embedded temperature-controlled ablation catheter in a porcine experimental model.

BACKGROUND: Novel diamond-embedded catheter enables precise temperature-controlled ablation. However, the effects of contact angle on lesion formation of this catheter are poorly understood. OBJECTIVE: The purpose of this study was to evaluate lesion formation using the temperature-controlled ablation catheter embedded with diamond at different angles in a porcine experimental model. METHODS: Freshly sacrificed porcine hearts were used. Radiofrequency catheter ablation was performed at 50 W for 15 seconds at an upper temperature setting of 60°C. The contact force (5g, 10g, 30g) and catheter contact angles (30°, 45°, 90°) were changed in each set (n = 13 each). Surface width, maximum lesion width, lesion depth, surface area, distance from the distal edge to the widest area, and impedance drop were evaluated. RESULTS: Surface width and maximum lesion width were longer at 30° than at 90° (P <.05). There were no significant differences in the lesion depth by catheter angle except at 30g. Surface area was larger at 30° than at 90° (P <.05). Distance from the distal edge to the widest area was longer at 30° than at 90° (P <.05). There were no significant differences in impedance drop according to catheter angle. CONCLUSION: With diamond-embedded temperature-controlled ablation catheters, lesion width increased at a shallower contact angle, whereas lesion depth did not. Surface area also increased at a shallower contact angle. This catheter created a large ablation lesion on the proximal side of the catheter, which looked like a "honey pot."

Left coronary cusp ablation for elimination of left ventricular summit premature ventricular complex.

We first reported that epicardial LAVA in the LV summit can be mapped and PVC was completely eliminated by RF ablation above the left coronary cusp using single catheter technique.

Needle-Tipped Catheter Ablation of Papillary Muscle Results in Deeper and Larger Ablation Lesions.

Ventricular tachycardia associated with papillary muscle (PM) is often refractory to standard radiofrequency ablation (RFA). The needle-tipped ablation catheter (NT-AC) has been used to treat deep intramyocardial substrates, but its use for PM has not been characterized. Using an ex vivo experimental platform, both 3 mm and 6 mm NT-AC created larger ablation lesion volumes and depths than open-irrigated ablation catheter did (OI-AC; e.g., 57.12 ± 9.70mm3 and 2.42 ± 0.22 mm, respectively; p < 0.01 for all comparisons). Longer NT-AC extension (6 mm) resulted in greater ablation lesion volumes and maximum depths (e.g., 333.14 ± 29.13mm3 and 6.46 ± 0.29 mm, respectively, compared to the shorter 3 mm NT-AC extension, 143.33 ± 12.77mm3, and 4.46 ± 0.14 mm; both p < 0.001). There were no steam pops. In conclusion, for PM ablation, the NT-AC was able to achieve ablation lesions that were larger and deeper than with conventional OI-AC. Ablation of PM may be another application for needle-tip ablation. Further studies are warranted to establish long-term safety and efficacy in human studies.