Lucie Sediva

Renal Sympathetic Denervation Using an Irrigated Radiofrequency Ablation Catheter for the Management of Drug-Resistant Hypertension

OBJECTIVES This study sought to assess whether renal sympathetic denervation (RSDN) can be achieved using an off-the-shelf saline-irrigated radiofrequency ablation (RFA) catheter typically employed for cardiac tissue ablation. BACKGROUND RSDN using a specialized solid-tip RFA catheter has recently been demonstrated to safely reduce systemic blood pressure in patients with refractory hypertension. For cardiac tissue ablation, RFA technology has evolved from nonirrigated to saline-irrigated ablation electrodes to improve both safety and effectiveness. METHODS Ten patients with resistant hypertension underwent renal angiography, followed by bilateral RSDN with a saline-irrigated RFA catheter. Ambulatory blood pressure recordings (24 h) were obtained at baseline, 1, 3, and 6 months after the procedure. Repeat renal angiography was performed during follow-up to assess for arterial stenosis or aneurysm. In 5 patients, pre- and post-procedural serum measures of renal function and sympathetic activity were obtained: aldosterone; metanephrine; normetanephrine; plasma renin activity; and creatinine. RESULTS Over a 6-month period: 1) the systolic/diastolic blood pressure decreased by -21/-11 mm Hg; 2) all patients experienced a decrease in systolic blood pressure of at least 10 mm Hg (range 10 to 40 mm Hg); 3) there was no evidence of renal artery stenosis or aneurysm at repeat angiography; and 4) there was a significant decrease in metanephrine (-12 ± 4, p = 0.003), normetanephrine (-18 ± 4, p = 0.0008), and aldosterone levels (-60 ± 33 ng/l, p = 0.02) at 3 months. There was no significant change in plasma renin activity (-0.2 mg/l/hod, p = 0.4). There was no significant change in serum creatinine (-1 mmol/l, p = 0.4). CONCLUSIONS These data provide the proof-of-principle that RSDN can be performed using an off-the-shelf saline-irrigated RFA catheter.

Permanent Leadless Cardiac Pacing: Results of the LEADLESS Trial

Background— Conventional cardiac pacemakers are associated with several potential short- and long-term complications related to either the transvenous lead or subcutaneous pulse generator. We tested the safety and clinical performance of a novel, completely self-contained leadless cardiac pacemaker. Methods and Results— The primary safety end point was freedom from complications at 90 days. Secondary performance end points included implant success rate, implant time, and measures of device performance (pacing/sensing thresholds and rate-responsive performance). The mean age of the patient cohort (n=33) was 77±8 years, and 67% of the patients were male (n=22/33). The most common indication for cardiac pacing was permanent atrial fibrillation with atrioventricular block (n=22, 67%). The implant success rate was 97% (n=32). Five patients (15%) required the use of >1 leadless cardiac pacemaker during the procedure. One patient developed right ventricular perforation and cardiac tamponade during the implant procedure, and eventually died as the result of a stroke. The overall complication-free rate was 94% (31/33). After 3 months of follow-up, the measures of pacing performance (sensing, impedance, and pacing threshold) either improved or were stable within the accepted range. Conclusions— In a prospective nonrandomized study, a completely self-contained, single-chamber leadless cardiac pacemaker has shown to be safe and feasible. The absence of a transvenous lead and subcutaneous pulse generator could represent a paradigm shift in cardiac pacing. Clinical Trial Registration— URL: . Unique identifier: [NCT01700244][1]. # CLINICAL PERSPECTIVE {#article-title-26} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01700244&atom=%2Fcirculationaha%2F129%2F14%2F1466.atomBackground— Conventional cardiac pacemakers are associated with several potential short- and long-term complications related to either the transvenous lead or subcutaneous pulse generator. We tested the safety and clinical performance of a novel, completely self-contained leadless cardiac pacemaker. Methods and Results— The primary safety end point was freedom from complications at 90 days. Secondary performance end points included implant success rate, implant time, and measures of device performance (pacing/sensing thresholds and rate-responsive performance). The mean age of the patient cohort (n=33) was 77±8 years, and 67% of the patients were male (n=22/33). The most common indication for cardiac pacing was permanent atrial fibrillation with atrioventricular block (n=22, 67%). The implant success rate was 97% (n=32). Five patients (15%) required the use of >1 leadless cardiac pacemaker during the procedure. One patient developed right ventricular perforation and cardiac tamponade during the implant procedure, and eventually died as the result of a stroke. The overall complication-free rate was 94% (31/33). After 3 months of follow-up, the measures of pacing performance (sensing, impedance, and pacing threshold) either improved or were stable within the accepted range. Conclusions— In a prospective nonrandomized study, a completely self-contained, single-chamber leadless cardiac pacemaker has shown to be safe and feasible. The absence of a transvenous lead and subcutaneous pulse generator could represent a paradigm shift in cardiac pacing. Clinical Trial Registration— URL: http://clinicaltrials.gov. Unique identifier: NCT01700244.

Visually guided laser ablation: a single-centre long-term experience

AIMS Durable isolation of the pulmonary veins (PVs) remains the cornerstone of treatment for paroxysmal atrial fibrillation (PAF) and is also used in the treatment of some patients with persistent atrial fibrillation. Visually guided laser ablation (VGLA) has been proven to be safe and effective as a treatment for atrial fibrillation (AF). It has shown high levels of durable PV isolation (PVI), even in the hands of less experienced users. This paper presents the long-term clinical outcomes of all patients treated with VGLA over the course of 4 years in the worlds most experienced centre: from early product feasibility work treating only PAF patients to our work using the commercially available product, when we also treated persistent AF patients. METHODS AND RESULTS One hundred and ninety-four patients (63 females, mean age 61 years) with either a history of drug-refractory PAF (time since initial diagnosis: 60.73 months) or persistent AF (time since initial diagnosis: 62.75 months) were treated in our laboratory with VGLA between 7 January 2009 and 17 May 2013. Follow-up of all patients was consistent with our standard clinical practice with a 7-day Holter being performed at the first clinical visit between 4 and 6 months and, for most patients, again at 12 months post-procedure. Twelve lead electrocardiograms were performed at all clinical visits. Recurrence of AF is defined as any documented AF episode >30 s. Acute procedural results show that 692 veins were acutely isolated with a mean procedure and fluoroscopy time of 226 and 20.4 min, respectively. One hundred and seventy (158 PAF and 12 persistent AF) patients reached 1 year of follow-up, 130 (82.3%) patients remained free of AF in the PAF group, and 9 (75%) in the persistent group. Eighty-seven PAF patients have now reached 24 months follow-up and 66 (75.9%) remain free of AF. Fifty-four PAF patients have reached 36 months follow-up with 41 (75.9%) remaining free of AF. Thirty-two PAF patients have reached 48 months follow-up and 24 (75%) remain free of AF. The peri-procedural complications we encountered were phrenic nerve injury in four patients (2.06%), tamponade or pericardial effusion in one patient (0.51%), stroke or transient ischaemic attack in one patient (0.514%), and vascular injury in six patients (3.09%). We experienced no cases of PV stenosis or atrio-oesophageal fistula. CONCLUSION Our single-centre experience using VGLA over 4 years shows that it can be used safely and effectively in normal clinical practice and gives high levels of acute PVI accompanied by good clinical outcomes, even after long-term follow-up.

Left Atrial Appendage Closure Under Intracardiac Echocardiographic Guidance: Feasibility and Comparison With Transesophageal Echocardiography.

Background Transcatheter left atrial appendage closure is an alternative therapy for stroke prevention in atrial fibrillation patients. These procedures are currently guided with transesophageal echocardiography and fluoroscopy in most centers. As intracardiac echocardiography (ICE) is commonly used in other catheter‐based procedures, we sought to determine the safety and effectiveness of intracardiac echocardiography–guided left atrial appendage closure with the Watchman device. Methods and Results A total of 27 patients (11 males, 77.0±8.5 years) with atrial fibrillation receiving Watchman left atrial appendage closure under intracardiac echocardiography guidance at a single center were investigated. All patients were implanted successfully. There were no major procedural complications. The overall procedure‐related complication rate was 14.8%, mainly due to access site hematoma. Transesophageal echocardiography demonstrated successful closure of the left atrial appendage in all patients at 45 days after device implant. Conclusions Transcatheter left atrial appendage closure with intracardiac echocardiography guidance is safe and feasible.

Initial clinical experience with a novel visualization and virtual electrode radiofrequency ablation catheter to treat atrial flutter

BACKGROUND Linear ablation lesions are used to treat a variety of cardiac arrhythmias. However, successful long-term outcome is hampered by both the uncertainty of catheter-tissue contact for any individual lesion and the difficulty in ensuring point-to-point lesion contiguity. OBJECTIVE A novel virtual electrode radiofrequency ablation catheter equipped with an endoscope to directly visualize the target tissue was used to ensure tissue contact and lesion contiguity along the cavotricuspid isthmus (CTI) to treat typical atrial flutter. METHODS In this feasibility study of five patients with drug-resistant CTI-dependent atrial flutter, catheter ablation was performed using the visualization virtual electrode radiofrequency ablation catheter. After standard femoral access, the ablation catheter was advanced to the tricuspid annulus under fluoroscopic and intracardiac echocardiography guidance. In three of five patients, the ablation procedure was performed during atrial flutter; the other two ablations were during coronary sinus pacing. RESULTS Conversion to sinus rhythm was noted after the delivery of 12 ± 7 lesions. Bidirectional CTI conduction block was successfully achieved in all patients. Initial, transient CTI block was first observed after delivering 19 ± 13 lesions; ultimately, 34 ± 18 lesions were required to achieve permanent bidirectional CTI block. The mean ablation and procedure times were 72 ± 42 and 151 ± 17 minutes. The mean fluoroscopy times for the ablation alone and the entire procedure were 13 ± 8 and 17 ± 7 minutes, respectively. CONCLUSIONS This study introduces the clinical feasibility of a novel paradigm for contiguous linear ablation: virtual electrode ablation under direct endoscopic visualization.

Single-site access robot-assisted epicardial mapping with a snake robot: preparation and first clinical experience

CardioARM, a highly flexible “snakelike” medical robotic system (Medrobotics, Raynham, MA), has been developed to allow physicians to view, access, and perform complex procedures intrapericardially on the beating heart through a single-access port. Transthoracic epicardial catheter mapping and ablation has emerged as a strategy to treat arrhythmias, particularly ventricular arrhythmias, originating from the epicardial surface. The aim of our investigation was to determine whether the CardioARM could be used to diagnose and treat ventricular tachycardia (VT) of epicardial origin. Animal and clinical studies of the CardioARM flexible robot were performed in hybrid surgical–electrophysiology settings. In a porcine model study, single-port pericardial access, navigation, mapping, and ablation were performed in nine animals. The device was then used in a small, single-center feasibility clinical study. Three patients, all with drug-refractory VT and multiple failed endocardial ablation attempts, underwent epicardial mapping with the flexible robot. In all nine animals, navigation, mapping, and ablation were successful without hemodynamic compromise. In the human study, all three patients demonstrated a favorable safety profile, with no major adverse events through a 30-day follow-up. Two cases achieved technical success, in which an electroanatomic map of the epicardial ventricle surface was created; in the third case, blood obscured visualization. These results, although based on a limited number of experimental animals and patients, show promise and suggest that further clinical investigation on the use of the flexible robot in patients requiring epicardial mapping of VT is warranted.

Electroanatomic Mapping of Cardiac Resynchronization Therapy

A 51-year-old man with a history of dilated cardiomyopathy presented with New York Heart Association Class III congestive heart failure. Despite optimal medical management, he continued to experience symptoms consistent with low-output failure: exertional dyspnea, orthopnea, and paroxysmal nocturnal dyspnea. He was hospitalized 3 times in the previous 4 months for congestive heart failure management. The baseline ECG revealed a left bundle-branch block with a QRS width of 172 ms, and the echocardiogram revealed an ejection fraction of 28%. He was referred to the cardiac arrhythmia service for cardiac resynchronization therapy. A biventricular pacemaker was implanted in the left prepectoral region. A transvenous approach was utilized to position both the standard right-sided leads, and the left ventricular lead was positioned …

Laser Balloon or Wide-Area Circumferential Irrigated Radiofrequency Ablation for Persistent Atrial Fibrillation: A Multicenter Prospective Randomized Study

Background Pulmonary vein isolation is the cornerstone of ablation for persistent atrial fibrillation (AF). The role of balloon catheters in this patient population remains ill defined. We sought to compare efficacy and safety of the laser balloon (LB) with wide-area circumferential pulmonary vein isolation using irrigated radiofrequency current (RF) ablation and 3-dimensional mapping. Methods and Results In 6 European centers, patients with persistent AF were prospectively randomized. Follow-up included 3-day Holter ECG recordings and office visits at 3, 6, and 12 months. The primary efficacy end point was freedom from AF between 90 and 365 days after a single ablation. The primary safety end point was the incidence of any periprocedural complications. Of 152 enrolled patients, 134 (n=68 LB and 66 RF; 63% men; mean age, 66+10 years) with persistent AF (median AF history, 14 months; Q1–Q3, 7–36 months) underwent pulmonary vein isolation and completed the entire follow-up. Baseline parameters were similar in both groups. Procedure and fluoroscopy times were similar in both groups (135±38 and 14±9 minutes (LB) versus 128±51 and 11±9 minutes). The primary efficacy end point was met by 71.2% versus 69.3%, in the LB and RF groups, respectively (P=0.40). In the LB group, stroke (n=1), a false aneurysm (n=1), and phrenic nerve palsy (n=1) were observed. In the RF group, 2 patients developed a false aneurysm, and 1 patient needed surgical repair. Conclusions An LB-guided strategy was associated with similar efficacy as wide-area circumferential pulmonary vein isolation using irrigated RF in patients with persistent AF. Clinical Trial Registration https://www.clinicaltrials.org. Unique identifier: NCT01863472.

Midterm Safety and Performance of a Leadless Cardiac Pacemaker: 3-Year Follow-up to the LEADLESS Trial (Nanostim Safety and Performance Trial for a Leadless Cardiac Pacemaker System)

Leadless cardiac pacemakers (LCPs) have been introduced to decrease lead- and pocket-related complications. Initial studies have shown short-term complication rates of 4% to 6.7% and adequate electric performance in up to 12 months of follow-up.1–3 However, to fully appreciate the clinical impact and the robustness of this novel technology, additional follow-up is required to determine the long-term safety and performance. In this study, we report the longest clinical follow-up to date: the 3-year results of the LEADLESS trial (Nanostim Safety and Performance Trial for a Leadless Cardiac Pacemaker System).4 Patients implanted with an LCP (Nanostim, St. Jude Medical/Abbott) were retrospectively assessed to evaluate the safety and performance of this device with a minimum of 3 years of follow-up. No patients were lost to follow-up. Medical records were analyzed from June 2014 until May 2016 and evaluated for (1) serious adverse device effects (SADEs) and (2) electric performance of the LCP. The primary outcome was freedom from SADEs (Kaplan-Meier estimate) at 40 months of follow-up. Categorical variables are presented as frequencies and continuous variables as means (±SD). Permission of the local institutional review boards was obtained for this retrospective analysis, and all participants gave written informed consent. Thirty-three patients (age 77±8 years, 67% male) were enrolled and were followed for a median duration of 38 months (range, 21–41 months). Two patients were …

Permanent Leadless Cardiac Pacing

Background— Conventional cardiac pacemakers are associated with several potential short- and long-term complications related to either the transvenous lead or subcutaneous pulse generator. We tested the safety and clinical performance of a novel, completely self-contained leadless cardiac pacemaker. Methods and Results— The primary safety end point was freedom from complications at 90 days. Secondary performance end points included implant success rate, implant time, and measures of device performance (pacing/sensing thresholds and rate-responsive performance). The mean age of the patient cohort (n=33) was 77±8 years, and 67% of the patients were male (n=22/33). The most common indication for cardiac pacing was permanent atrial fibrillation with atrioventricular block (n=22, 67%). The implant success rate was 97% (n=32). Five patients (15%) required the use of >1 leadless cardiac pacemaker during the procedure. One patient developed right ventricular perforation and cardiac tamponade during the implant procedure, and eventually died as the result of a stroke. The overall complication-free rate was 94% (31/33). After 3 months of follow-up, the measures of pacing performance (sensing, impedance, and pacing threshold) either improved or were stable within the accepted range. Conclusions— In a prospective nonrandomized study, a completely self-contained, single-chamber leadless cardiac pacemaker has shown to be safe and feasible. The absence of a transvenous lead and subcutaneous pulse generator could represent a paradigm shift in cardiac pacing. Clinical Trial Registration— URL: . Unique identifier: [NCT01700244][1]. # CLINICAL PERSPECTIVE {#article-title-26} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01700244&atom=%2Fcirculationaha%2F129%2F14%2F1466.atomBackground— Conventional cardiac pacemakers are associated with several potential short- and long-term complications related to either the transvenous lead or subcutaneous pulse generator. We tested the safety and clinical performance of a novel, completely self-contained leadless cardiac pacemaker. Methods and Results— The primary safety end point was freedom from complications at 90 days. Secondary performance end points included implant success rate, implant time, and measures of device performance (pacing/sensing thresholds and rate-responsive performance). The mean age of the patient cohort (n=33) was 77±8 years, and 67% of the patients were male (n=22/33). The most common indication for cardiac pacing was permanent atrial fibrillation with atrioventricular block (n=22, 67%). The implant success rate was 97% (n=32). Five patients (15%) required the use of >1 leadless cardiac pacemaker during the procedure. One patient developed right ventricular perforation and cardiac tamponade during the implant procedure, and eventually died as the result of a stroke. The overall complication-free rate was 94% (31/33). After 3 months of follow-up, the measures of pacing performance (sensing, impedance, and pacing threshold) either improved or were stable within the accepted range. Conclusions— In a prospective nonrandomized study, a completely self-contained, single-chamber leadless cardiac pacemaker has shown to be safe and feasible. The absence of a transvenous lead and subcutaneous pulse generator could represent a paradigm shift in cardiac pacing. Clinical Trial Registration— URL: http://clinicaltrials.gov. Unique identifier: NCT01700244.