Malte Kuniss

Circumferential Pulmonary Vein Isolation With the Cryoballoon Technique: Results From a Prospective 3-Center Study

OBJECTIVES The purpose of this study was to investigate the efficacy safety of the novel cryoballoon device (Arctic Front, Cryocath, Quebec, Canada). BACKGROUND Antral pulmonary vein (PV) ablation with radiofrequency energy is widely used as a strategy for catheter ablation of paroxysmal atrial fibrillation (PAF). A novel double lumen cryoballoon catheter was designed for circumferential pulmonary vein isolation (PVI) with the cryoablation technique. METHODS We consecutively enrolled 346 patients with symptomatic, drug refractory paroxysmal (n = 293) or persistent (n = 53) atrial fibrillation (AF). In all patients, PVI of all targeted PVs was the therapeutic aim. The primary end points of this nonrandomized study were: 1) acute isolation rate of targeted PV; and 2) first electrocardiogram-documented recurrence of AF. The secondary end point was occurrence of PV stenosis or atrio-esophageal fistula. RESULTS The 1,360 of 1,403 PVs (97%) were targeted with balloons or balloons in combination with the use of Freezor Max (Cryocath). We found that ablation with the cryoballoon resulted in maintenance of sinus rhythm in 74% of patients with PAF and 42% of patients with persistent AF. No PV narrowing occurred. The most frequent complication was right phrenic nerve palsy observed during cryoballoon ablation at the right superior PV. CONCLUSIONS Pulmonary vein isolation with a new cryoballoon technique is feasible. Sinus rhythm can be maintained in the majority of patients with PAF by circumferential PVI using a cryoballoon ablation system. Cryoablation was less effective in patients with persistent AF than in patients with PAF.

Left Ventricular Lead Position and Clinical Outcome in the Multicenter Automatic Defibrillator Implantation Trial–Cardiac Resynchronization Therapy (MADIT-CRT) Trial

Background— An important determinant of successful cardiac resynchronization therapy for heart failure is the position of the left ventricular (LV) pacing lead. The aim of this study was to analyze the impact of the LV lead position on outcome in patients randomized to cardiac resynchronization-defibrillation in the Multicenter Automatic Defibrillator Implantation Trial–Cardiac Resynchronization Therapy (MADIT-CRT) study. Methods and Results— The location of the LV lead was assessed by means of coronary venograms and chest x-rays recorded at the time of device implantation. The LV lead location was classified along the short axis into an anterior, lateral, or posterior position and along the long axis into a basal, midventricular, or apical region. The primary end point of MADIT-CRT was heart failure (HF) hospitalization or death, whichever came first. The LV lead position was assessed in 799 patients, (55% patients ≥65 years of age, 26% female, 10% LV ejection fraction ⩽25%, 55% ischemic cardiomyopathy, and 71% left bundle-branch block) with a follow-up of 29±11 months. The extent of cardiac resynchronization therapy benefit was similar for leads in the anterior, lateral, or posterior position (P=0.652). The apical lead location compared with leads located in the nonapical position (basal or midventricular region) was associated with a significantly increased risk for heart failure/death (hazard ratio=1.72; 95% confidence interval, 1.09 to 2.71; P=0.019) after adjustment for the clinical covariates. The apical lead position was also associated with an increased risk for death (hazard ratio=2.91; 95% confidence interval, 1.42 to 5.97; P=0.004). Conclusion— LV leads positioned in the apical region were associated with an unfavorable outcome, suggesting that this lead location should be avoided in cardiac resynchronization therapy. Clinical Trial Registration— URL: http://clinicaltrials.gov. Unique identifier: NCT00180271.

Survival with Cardiac-Resynchronization Therapy in Mild Heart Failure

BACKGROUND The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) showed that early intervention with cardiac-resynchronization therapy with a defibrillator (CRT-D) in patients with an electrocardiographic pattern showing left bundle-branch block was associated with a significant reduction in heart-failure events over a median follow-up of 2.4 years, as compared with defibrillator therapy alone. METHODS We evaluated the effect of CRT-D on long-term survival in the MADIT-CRT population. Post-trial follow-up over a median period of 5.6 years was assessed among all 1691 surviving patients (phase 1) and subsequently among 854 patients who were enrolled in post-trial registries (phase 2). All reported analyses were performed on an intention-to-treat basis. RESULTS At 7 years of follow-up after initial enrollment, the cumulative rate of death from any cause among patients with left bundle-branch block was 18% among patients randomly assigned to CRT-D, as compared with 29% among those randomly assigned to defibrillator therapy alone (adjusted hazard ratio in the CRT-D group, 0.59; 95% confidence interval [CI], 0.43 to 0.80; P<0.001). The long-term survival benefit of CRT-D in patients with left bundle-branch block did not differ significantly according to sex, cause of cardiomyopathy, or QRS duration. In contrast, CRT-D was not associated with any clinical benefit and possibly with harm in patients without left bundle-branch block (adjusted hazard ratio for death from any cause, 1.57; 95% CI, 1.03 to 2.39; P=0.04; P<0.001 for interaction of treatment with QRS morphologic findings). CONCLUSIONS Our findings indicate that in patients with mild heart-failure symptoms, left ventricular dysfunction, and left bundle-branch block, early intervention with CRT-D was associated with a significant long-term survival benefit. (Funded by Boston Scientific; ClinicalTrials.gov numbers, NCT00180271, NCT01294449, and NCT02060110.).

Cryoablation Versus Radiofrequency Energy for the Ablation of Atrioventricular Nodal Reentrant Tachycardia (the CYRANO Study) Results From a Large Multicenter Prospective Randomized Trial

Background— Cryoablation has emerged as an alternative to radiofrequency catheter ablation (RFCA) for the treatment of atrioventricular (AV) nodal reentrant tachycardia (AVNRT). The purpose of this prospective randomized study was to test whether cryoablation is as effective as RFCA during both short-term and long-term follow-up with a lower risk of permanent AV block. Methods and Results— A total of 509 patients underwent slow pathway cryoablation (n=251) or RFCA (n=258). The primary end point was immediate ablation failure, permanent AV block, and AVNRT recurrence during a 6-month follow-up. Secondary end points included procedural parameters, device functionality, and pain perception. Significantly more patients in the cryoablation group than the RFCA group reached the primary end point (12.6% versus 6.3%; P=0.018). Whereas immediate ablation success (96.8% versus 98.4%) and occurrence of permanent AV block (0% versus 0.4%) did not differ, AVNRT recurrence was significantly more frequent in the cryoablation group (9.4% versus 4.4%; P=0.029). In the cryoablation group, procedure duration was longer (138±54 versus 123±48 minutes; P=0.0012) and more device problems occurred (13 versus 2 patients; P=0.033). Pain perception was lower in the cryoablation group (P<0.001). Conclusions— Cryoablation for AVNRT is as effective as RFCA over the short term but is associated with a higher recurrence rate at the 6-month follow-up. The risk of permanent AV block does not differ significantly between cryoablation and RFCA. The potential benefits of cryoenergy relative to ablation safety and pain perception are counterbalanced by longer procedure times, more device problems, and a high recurrence rate. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00196222.

MEDAFI-Trial (Micro-embolization during ablation of atrial fibrillation): comparison of pulmonary vein isolation using cryoballoon technique vs. radiofrequency energy

AIMS Cerebral embolism is a possible serious complication during catheter ablation of atrial fibrillation (AF). The purpose of this prospective pilot study was to analyse the incidence and possible impact of cryo ablation on cerebral lesions and possible differences to radiofrequency (RF) ablation during pulmonary vein isolation (PVI). METHODS AND RESULTS Pulmonary vein isolation was performed in 89 patients, either with the cryoballoon technique (n = 45) or with RF ablation (n = 44). Phenprocoumon was stopped 3 days before intervention and replaced by subcutaneous low-molecular-weight heparin. During the catheter procedure, an infusion of unfractionated heparin was maintained to achieve an activated clotting time (ACT) of > 300 s. Cerebral magnetic resonance imaging scans were performed 1 day before and after PVI, and at 3-month follow-up. Chronic lesions were observed in 11 patients (12.3%) before PVI without statistically significant difference between the two groups. None of the patients had neurological symptoms during or following the procedure. Seven patients (7.9%) developed acute lesions 1 day after PVI, without statistically significant difference between the group treated by cryoenergy (8.9%) and RF ablation (6.8%). Patients with acute lesions were significantly older compared with those without acute cerebral lesions. No additional cerebral lesions during follow-up were observed. CONCLUSION A considerable portion of patients with AF but without any neurological symptoms had chronic cerebral lesions before PVI. Additional acute lesions could be added after the procedure. Both ablation techniques showed additional cerebral acute lesions with no neurological symptoms after PVI.

Cryoballoon versus RF ablation in paroxysmal atrial fibrillation: results from the German Ablation Registry.

Catheter ablation is used extensively with curative intention in atrial fibrillation. Radiofrequency ablation has long been a standard of care, while cryoballoon technology has emerged as a feasible approach with promising results. Prospective multicenter registry data referring to both ablation technologies in AF ablation therapy are lacking.

Neuropsychological decline after catheter ablation of atrial fibrillation

BACKGROUND Cerebral embolic events represent recognized side effects after catheter ablation in the treatment of recurrent atrial fibrillation (AF). OBJECTIVE The study was performed to analyze the neuropsychological outcome and to detect new embolic ischemic brain lesions after therapeutic left atrial catheter ablation of AF. METHODS We enrolled 23 patients with recurrent AF who underwent elective circumferential pulmonary vein isolation. The primary endpoint was the neuropsychological outcome 3 months after intervention in contrast to the results of non-AF controls (n = 23) without ablation and in covariance of baseline performance. Cerebral diffusion-weighted magnetic resonance imaging (DWI) was performed in 21 AF patients at baseline, 2-4 days, and 3 months after intervention. RESULTS In 3/21 patients (14.3%), new ischemic lesions were detected on DWI shortly after intervention. In one patient, a territorial middle cerebral artery infarct occurred with severe clinical symptoms. The other two patients represented clinically silent small lesions. In contrast to the control group and in covariance of baseline performance, the ablation group showed worse neuropsychological outcome in verbal memory (one of five cognitive domains) with an effect size of d = 0.93[t (.05; 42) = -3.53; P < .001; false discovery rate (FDR)(crit) ≤ .01]. CONCLUSION Adverse neuropsychological changes after left atrial catheter ablation are verifiable in verbal memory and, conjoined with ischemic brain lesions on DWI, might represent cerebral side effects of this procedure.

Cryoballoon ablation of paroxysmal atrial fibrillation: 5-year outcome after single procedure and predictors of success.

AIMS Long-term efficacy following cryoballoon (CB) ablation of atrial fibrillation (AF) remains unknown. This study describes 5 years follow-up results and predictors of success of CB ablation in patients with paroxysmal atrial fibrillation (PAF). METHODS AND RESULTS In total, 163 patients were enrolled with symptomatic, drug refractory PAF. Pulmonary vein isolation (PVI) with CB technique was performed. Primary endpoint of this consecutive single-centre study was first electrocardiogram-documented recurrence of AF, atrial tachycardia or atrial flutter (AFLAT). Five years success rate after single CB ablation was 53%. In 70% of the patients acute complete PVI was achieved with a single 28 mm balloon. The univariate predictors of AFLAT recurrence were (1) size of left atrium, with normalized left atrium (NLA) ≥10.25 [hazard ratios (HR) of 1.81, 95% confidence interval (CI): 1.28-2.56] when compared with NLA <10.25 (35% vs. 53%, P = 0.0001) and (2) renal function, with impaired glomerular filtration rate (GFR) <80 ml/min (HR of 1.26, 95% CI: 1.02-1.57) when compared with GFR ≥80 ml/min (45% vs. 53%, P = 0.041). Normalized left atrium ≥10.25 was the sole independent predictor for outcome (HR 2.11; 95% CI: 1.34-3.31; P = 0.0001). CONCLUSIONS Sinus rhythm can be maintained in a substantial proportion of patients with PAF even 5 years after circumferential PVI using CB ablation. The rate of decline in freedom from AFLAT was highest within the first 12 months after the index procedure. The patients with enlarged left atrium and/or impaired renal function have lower outcome.

Pulmonary Vein Stenting for the Treatment of Acquired Severe Pulmonary Vein Stenosis after Pulmonary Vein Isolation: Clinical Implications after Long-Term Follow-Up of 4 Years

Pulmonary Vein Stenting. Introduction: Severe pulmonary vein stenosis (PVS) after catheter ablation of atrial fibrillation (AF) is a well‐recognized complication with a further reported incidence of 1.3%. The preferred therapy for symptomatic PVS is pulmonary vein (PV) angioplasty, but this treatment modality is followed by restenosis in 44–70%. Whether there is additional long‐term benefit from PVS stenting is uncertain. The aim of this study was the evaluation of the long‐term success after PV stenting of severe stenosis.

Percutaneous Pulmonary Vein Stenting for the Treatment of Severe Stenosis After Pulmonary Vein Isolation

Introduction: Pulmonary vein stenosis (PVS) is a potential complication of pulmonary vein isolation (PVI) using radiofrequency energy. The aim of our study was the evaluation of the severity and long‐term outcome of primary angioplasty and angioplasty with pulmonary vein stenting for PVS.