Removal of active-fixation coronary sinus leads using a mechanical rotation extraction device.

BACKGROUND: Active fixation coronary sinus (CS) leads are widely used in cardiac resynchronization therapy (CRT). Due to their low dislodgement rates they are an attractive option for implanters. However, extraction of active fixation leads is a complex procedure that bears potential fatal risks for patients. METHODS: We analyzed all patients undergoing StarFix® (Medtronic Inc., Minneapolis, MN, USA) extraction because of severe infection at our institution. Indication for extraction was severe device infection. Procedural outcomes as well as patient characteristics are reported. For removal of the leads a 9-Fr Evolution® (Cook Intravascular Inc., Leechburg, PA, USA) mechanical rotation extraction sheath was used. RESULTS: Between 2011 and 2014, six patients underwent extraction of StarFix® leads. One patient was female, whereas the others were males (mean age 64 ± 12 years). Implant duration was 46.5 ± 8.2 months before removal. All leads could be successfully extracted totally with the Evolution®. In one patient (16.6%) pericardial tamponade occurred immediately requiring surgical intervention. After establishment of cardiopulmonary bypass a 5-mm sharp cut in the lateral vein of the CS could be identified. It was fixed and the patient survived. On all leads, significant tissue growth between the fixation lobes could be observed. CONCLUSION: As illustrated by our cases, Attain StarFix® leads implanted years ago can be extracted with the help of a mechanical extraction sheath. However, this procedure bears potential risks and should only be performed with a cardiac surgery standby. If clinicians evaluate the implantation of Attain StarFix® leads in patients who are young or at high risk for device infection, they should be aware of these findings.

An electrical plasma surgery tool for device replacement--retrospective evaluation of complications and economic evaluation of costs and resource use.

BACKGROUND: Device replacements bear many potential risks for patients. Electrocautery should be used cautiously because of heating of the cautery tip which may lead to insulation melting. The PEAK PlasmaBlade™ (Medtronic Inc., Minneapolis, MN, USA) uses a novel technology to cut tissue. The objective of this study was to evaluate if this instrument is less destructive and can decrease complications and shorten procedure times. METHODS AND RESULTS: Two groups were compared: in group 1, surgery was done with scissors and conventional electrocautery, whereas the PEAK PlasmaBlade™ was used in group 2. Procedure time and complication rates were retrospectively investigated. Group 1 comprised 509 patients, while group 2 consisted of 102 patients. Procedure time in group 2 was significantly shorter with 28.4 ± 8.9 minutes than in group 1 with 47.5 ± 24.5 minutes (P < 0.001). The hospital stay was also reduced (2.1 ± 2.2 days versus 3.1 ± 2.4 days, P < 0.001). One major complication occurred in only 2.4% (two patients) of group 2 and in 6.9% (35 patients) of group 1. There were no damaged leads in group 2 compared to 5.7% in group 1 (P = 0.008). Cost analyses showed that the use of The PEAK PlasmaBlade™ instead of conventional electrocautery resulted in cost savings of €120/patient. CONCLUSION: Device replacement is associated with a notable complication risk. Our investigation showed that a new device for generator replacement resulted in significantly reduced procedure time and length of hospital stay while completely avoiding lead damage, which translated into considerable cost savings in a real world setting.

NT-pro-BNP as a Predictor for Recurrence of Atrial Fibrillation after Primary Cryoballoon Pulmonary Vein Isolation.

NT-pro-BNP is produced in the cardiac atria and ventricles in response to increased wall stress. It may be a marker of both AF disease progression and co-morbidities that affect success after pulmonary vein isolation (PVI). This single-center retrospective study analyzed the association between pre-procedural NT-pro-BNP serum levels and the long-term outcome after a first-ever PVI in cryo-technique. Patients were followed by searching the hospital information system and conducting structured telephone interviews. Treatment failure was defined as any relapse of atrial fibrillation (AF) occurring 90 days after the index PVI at the earliest. Kaplan−Meier survival curves and Cox proportional hazards models were computed to assess the impact of NT-pro-BNP on AF recurrence. Following 374 patients over a median of 3.8 years (range: 0.25−9.4 years), baseline NT-pro-BNP was associated with the combined endpoint in univariate analysis (HR 1.04 per 100 pg/mL increase, 95% CI: 1.02−1.07, p < 0.001). Results were virtually unchanged in the multivariate model or if the data were log-transformed. Intraprocedural left atrial pressure correlated positively with log NT-pro-BNP. NT-pro-BNP was associated with AF relapse during a long-term follow-up after first-ever cryo-PVI in our cohort of patients with predominantly normal left ventricular function. This lab parameter is easy to obtain and has significant potential to guide treatment decisions.

Cardiac Computed Tomography-Derived Left Atrial Volume Index as a Predictor of Long-Term Success of Cryo-Ablation in Patients With Atrial Fibrillation.

Patients with symptomatic, drug-refractory atrial fibrillation (AF) are frequently treated with catheter ablation. Cryo-ablation has been established as an alternative to radiofrequency ablation but long-term outcome data are still limited. This study aimed at elucidating the influence of the left atrial volume index (LAVI), derived from cardiac computed tomography (cCT) data, on the long-term outcome of ablation-naïve AF patients, after their first cryo-ablation. 415 patients (n = 290 [69.90%] male, 60.00 [IQR: 53.00 to 68.00] years old) who underwent a cCT and subsequent cryo-ablation index procedure were included in this single centre retrospective data analysis. A composite end point was defined (AF on electrocardiogram and/or electric cardioversion and/or re-do). Patients were closely followed for a year and then contacted for long-term follow-up after a median of 53.00 months (IQR: 34.50 to 73.00). Statistical analyses of the outcome and predictors of AF recurrence were conducted. In 224 patients (53.98%) no evidence of AF recurrence could be found. LAVI differed significantly between the positive and adverse (AF recurrence) outcome group (49.96 vs 56.07 ml/m2, p < 0.001). Cox regression analyses revealed cCT LAVI (HR: 1.022, 95% CI: 1.013 to 1.031, p < 0.001), BMI (HR: 1.044, 95% CI: 1.005 to 1.084, p < 0.05) and the type of AF (HR: 1.838 for nonparoxysmal AF, 95% CI: 1.214 to 2.781, p < 0.01) to be effective predictors of AF recurrence. A prognostic cCT LAVI cut-off value of 51.99 ml/m2 was calculated and must be validated in future prospective studies. In conclusion, LAVI is an accurate, yet underutilized predictor of AF recurrence after pulmonary vein isolation with cryo-energy and scores for calculating AF recurrence or progression risks might underemphasize the importance of CT-derived LAVI as a predictive factor.

64-Detector CT angiography in renal artery stent evaluation: prospective comparison with selective catheter angiography.

PURPOSE: To prospectively assess the diagnostic accuracy of 64-detector computed tomographic (CT) renal artery (RA) angiography for the evaluation of RA in-stent restenosis (ISR) by using selective catheter RA angiography as the reference standard. MATERIALS AND METHODS: Institutional review board approval and written informed consent were obtained. Eighty-six patients (46 men, 40 women; mean age +/- standard deviation, 71 years +/- 9) with 95 RA stents were examined with 64-detector CT RA angiography by experienced radiologists 1 day before selective catheter RA angiography was performed by experienced cardiologists. Each group was blinded to the results of the other imaging method. For image reconstruction, a standard (B25f) and an edge-enhancing (B46f) kernel were chosen. An ISR of more than 50% was considered as hemodynamically significant. Sensitivity, specificity, and positive and negative predictive values for the detection of ISR by using CT RA angiography were calculated. RESULTS: At CT RA angiography, 93 (98%) of 95 stents were assessable for diagnosis. Two stents could not be evaluated owing to hardening artifacts affected by vessel calcifications. All nine cases of significant ISR seen at selective catheter RA angiography were correctly diagnosed by using CT RA angiography, giving a sensitivity of 100% and a negative predictive value of 100%. One case of nonsignificant ISR seen at selective catheter RA angiography was interpreted as significant by using CT RA angiography, giving a specificity of 99% and a positive predictive value of 90%. In four of 78 patients without ISR seen at selective catheter RA angiography, CT RA angiography showed nonsignificant ISR, giving a specificity of 95% and a positive predictive value of 56%. CONCLUSION: Sixty-four-detector CT RA angiography can provide an excellent noninvasive technique to help detect and evaluate ISR within the RA stents used in our study.

Acute results of pulmonary vein isolation in patients with paroxysmal atrial fibrillation using a single mesh catheter.

INTRODUCTION: Catheter-based pulmonary vein isolation (PVI) is an established therapy to treat patients with paroxysmal atrial fibrillation. We evaluated the efficacy of a simplified interventional procedure for PVI by using a single mesh catheter for mapping as well as ablation and with guidance of fluoroscopic imaging only. METHODS AND RESULTS: Forty-eight patients with paroxysmal atrial fibrillation were screened by cardiac computed tomography for their anatomical suitability to undergo PVI with the high-density mesh ablator catheter as the only left atrial device. The procedure was performed in 26 patients (12 males, mean age 61 years) who met the criteria of four clearly separated pulmonary veins (PVs) with an ostial diameter of 15-25 mm. No three-dimensional mapping systems or additional ablation devices were used. In all 26 patients, all four PVs could be accessed and mapped with the high-density mesh ablator catheter. Electrical isolation was achieved in 99 of 102 (97%) of the pulmonary veins that revealed PV potentials. Mean total procedure time and fluoroscopy time were 187 +/- 36 minutes and 34.6 +/- 10.0 minutes, respectively. CONCLUSION: The single-catheter approach using the high-density mesh ablator catheter for mapping as well as ablation reveals a high acute success rate of PVI while, at the same time, reducing the complexity of the procedure, and the procedure time. Long-term data on clinical success are needed to justify this simplified approach.

Implantation depth measured by 64-slice computed tomography is associated with permanent pacemaker requirement following transcatheter aortic valve implantation with the Core Valve(®) system.

BACKGROUND: Patients undergoing transcatheter aortic valve implantation (TAVI) are at increased risk for post-interventional conduction disturbances leading to pacemaker (PM) implantation. We analyzed the association between implantation depth within the left ventricular outflow tract (LVOT), measured by 64-slice computed tomography (CT), and 'index electrocardiographic (ECG) changes' (new onset atrioventricular-block grade II or III or left bundle branch block with PR interval prolongation >200ms). METHODS: We evaluated patients who underwent TAVI with the Core Valve(®) revalving system (Medtronic, Minneapolis, MN, USA) for treatment of severe aortic stenosis at our department. Patients with a prior PM implantation and patients for whom no CT scan was available after 3 months were excluded from analysis. We assessed implantation depth of the prosthesis within the LVOT as possible risk factors for the development of post-interventional 'index ECG changes' resulting in PM implantation and compared it with individual patient data as well as echocardiographic and electrocardiographic parameters. RESULTS: The final study cohort comprised 53 patients for whom a 64-slice CT scan was available (mean age 81.7±5.1 years, 36% male). Twenty-eight of these finally underwent PM implantation due to 'index ECG changes' within the first 48hours after TAVI. Univariate logistic regression analysis could identify implantation depth of the prosthesis as the only significantly correlated risk factor for PM need in our cohort (OR 1.27, 95% CI: 1.08-1.51, p=0.004). A cut-off value of 6mm predicted this need with a sensitivity of 89% and specificity of 40%. CONCLUSION: Implantation depth of the Core Valve(®) into the LVOT was associated with post-procedural PM requirement. Thereby, a cut-off value of 6mm, as measured by 64-slice CT, proved useful to define patients at risk for PM requirement.

Individual-patient visit-by-visit office and ambulatory blood pressure measurements over 24months in patients undergoing renal denervation for hypertension.

BACKGROUND: Renal denervation (RDN) is a promising treatment option in addition to medical antihypertensive treatment in patients suffering from resistant hypertension. Despite the growing interest in RDN, only few long-term results are published so far. METHODS: We systematically investigated the effects of RDN on ABPM in a consecutive series of patients with resistant hypertension out to 24 months. Office BP measurements and ABPM assessment were offered at 3, 6, 12 and 24 months. The patients with an average systolic BP reduction of more than 10 mmHg in office BP 6months after RDN were classified as responders. Additional to this classical responder concept, we categorized response to RDN by an individual-patient visit-by-visit evaluation of office BP and 24-hour-BP, separately. RESULTS: We included 32 patients. In 21 patients (65.6%) we found a mean systolic BP reduction >10 mmHg in office BP six months after RDN. These patients were classified as responders. In responders, mean office BP dropped from 175.3 ± 15.9/96 ± 14.2 mmHg to 164.8 ± 24.4/93.2 ± 10.4 mmHg (p=0.040/p=0.323) and mean 24-h BP in ABPM decreased from 146.8 ± 17.0/89.1 ± 11 mmHg to 136.8 ± 15.0/83.2 ± 10.7 mmHg after 24 months (p=0.034/p=0.014). Additionally, we performed a visit-by-visit evaluation of all patients and results were divided in larger-than-median and smaller-than-median response. By this evaluation, we found a high variation of office BP reductions and the 24-hour BP results demonstrated a significant BP reduction in patients with larger-than-median response, which sustained over the 24 months of follow-up. CONCLUSIONS: In contrast to the observed variation of office BP measurements, ABPM demonstrated a reproducible and sustained significant BP reduction in patients with larger-than-median response to RDN.

Pulmonary vein isolation with Mesh Ablator versus cryoballoon catheters: 6-month outcomes.

INTRODUCTION: We sought to compare the results of pulmonary vein (PV) ablation using the high-density Mesh Ablator catheter (MESH) versus the cryoballoon (CRYO). METHODS AND RESULTS: From August 2007 to November 2009, all patients with paroxysmal atrial fibrillation scheduled for a first procedure of PV isolation were screened by cardiac computed tomography for anatomical suitability to undergo ablation with a circumferential ostial ablation catheter. The procedure was finally performed in 79 out of 120 patients matching the criteria of four clearly separated PVs with an ostial diameter of 15-25 mm. The first consecutive 43 patients were treated with the MESH; the following 36 consecutive patients were treated with the CRYO. The procedures were performed with up to 900 s of either pulsed radiofrequency energy delivered by the MESH or cryoenergy applied with the CRYO. The clinical success rate was evaluated 6 months after a single procedure. Isolation of all PVs could be achieved in 40 patients (93%) in the MESH group compared to 31 patients (89%) in the CRYO group (p = ns). Major complications consisted of one tamponade in the MESH group and one reversible phrenic nerve palsy in the CRYO group. After 6 months, the clinical success rate was 44% (19/43 P) in the MESH versus 69% (25/36 P) in the CRYO group (p < 0.05). CONCLUSION: Both methods of simplified circumferential PV ablation reveal a high acute success rate. The clinical 6-month results of the MESH are statistically significant inferior compared to the CRYO.

One-year follow-up after pulmonary vein isolation using a single mesh catheter in patients with paroxysmal atrial fibrillation.

BACKGROUND: Catheter-based pulmonary vein (PV) isolation has emerged as established therapy for patients with paroxysmal atrial fibrillation (AF). OBJECTIVE: The purpose of this study was to determine the results at 1-year follow-up after PV isolation was performed using a single novel multipolar catheter for mapping and ablation. METHODS: Patients with paroxysmal AF were screened by cardiac computed tomography for anatomic suitability to undergo PV ablation with the Bard HD Mesh Ablator Catheter (MESH). PV isolation with the MESH was performed only in patients who matched the criteria of four clearly separated PVs with an ostial diameter of 15 to 25 mm. RESULTS: PV isolation with the MESH was performed in 36 (55%) of 65 screened patients. In all 36 patients, all PVs could be mapped with the MESH. Electrical isolation could be achieved in 135 (96%) of 140 PVs that revealed PV potentials. One-year follow-up was completed for 35 patients; one patient was lost to follow-up. Ten (29%) patients reported to be symptom-free and had no AF during three 48-hour ECGs, whereas 25 (71%) patients suffered from AF recurrences. Reablation performed in 11 patients revealed reconnection of three PVs in 6 patients and four PVs in 5 patients. CONCLUSION: The single-catheter approach using the MESH for mapping and ablation was associated with a high AF recurrence rate within the first year despite a high acute success rate. Thus, the minimalist complexity of the procedure must be balanced with the poor clinical success leading to a high number of second procedures.

Clinical experience with routine use of a single combined mapping and ablation catheter for isolation of pulmonary veins in patients with paroxysmal atrial fibrillation.

BACKGROUND: Catheter-based isolation of pulmonary veins has become established treatment for patients with paroxysmal atrial fibrillation. We wished to simplify the interventional procedure by using a single novel multipolar catheter for mapping and ablation in appropriate patients. METHODS: Sixty-four patients with paroxysmal atrial fibrillation scheduled for pulmonary vein isolation were screened by cardiac computed tomography for anatomic suitability to undergo a simplified procedure with the high-density mesh ablator catheter (MESH) as the only left atrial device. The procedure was undertaken in 38 patients matching the criteria of four clearly separated pulmonary veins with ostial diameters 15-25 mm; the remaining 26 patients served as a control group and were treated using a three-dimensional mapping system guided ablation using a circular mapping catheter and a single-point ablation catheter. RESULTS: In all 38 patients, all four pulmonary veins could be accessed and mapped with the MESH. Using the MESH, electrical isolation was achieved in 142/148 (96%) pulmonary veins with recorded potentials. In the control group, 100/105 (95%) pulmonary veins with recorded potentials could be isolated. After 6 months, clinical results did not differ significantly between the two treatment groups. CONCLUSION: In appropriate patients, the routine single catheter approach with the MESH for mapping and ablation yields a high acute success rate despite the reduced complexity of the procedure. Long-term data on clinical success rates are needed to justify this simplified approach.

Pre-injection of magnesium sulfate enhances the efficacy of ibutilide for the conversion of typical but not of atypical persistent atrial flutter.

BACKGROUND: Ibutilide is a class III antiarrhythmic drug, frequently used for conversion of atrial fibrillation and flutter. Retrospective cohort evaluations found that intravenous application of magnesium enhances the efficacy of ibutilide for chemical conversion of these arrhythmias. This prospective study sought to investigate the effects of intravenously pre-injected magnesium on the conversion rate of ibutilide for typical and atypical atrial flutter. METHODS: We performed a prospective, randomized, placebo-controlled study. Patients with typical atrial flutter (TAF) or atypical atrial flutter (AAF) were randomized to receive either 4 g of intravenous magnesium sulfate or placebo immediately before administration of a maximum dose of 2 mg of ibutilide fumarate. Continuous rhythm monitoring for 4 h provided information on conversion to sinus rhythm. QT interval durations were measured before randomization, after magnesium, as well as 30 min and 4 h after starting ibutilide infusion. RESULTS: We randomized 117 patients (58 with and 59 without pre-injection of magnesium; 65 with TAF and 52 with AAF). In patients with TAF, pre-injection of magnesium significantly improved the efficacy of ibutilide for conversion (85% with magnesium vs. 59% with placebo, p=0.017). In patients with AAF, no significant difference in conversion rates between patients receiving magnesium or placebo was detected (48% vs. 56%, p=0.189). Pre-injection of magnesium did not significantly influence the QT intervals at any time after administration of ibutilide. CONCLUSIONS: Pre-injection of magnesium significantly enhances the efficacy of ibutilide for the conversion of TAF but not of AAF.

Incidence of stent thrombosis in patients with drug eluting stents and short-term dual antiplatelet therapy.

AIMS: This study sought to investigate the incidence of stent thrombosis (ST) in patients treated with drug-eluting stents (DES) and clearly defined short-term dual antiplatelet therapy (DAT) for three or six months for sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES), respectively. METHODS AND RESULTS: A series of 1023 consecutive patients with 1,414 stented lesions and prescribed short-term DAT were followed for at least two years after DES implantation. The individual durations of DAT, the rate of ischaemic events, and survival status were assessed. Follow-up was completed for 1017 patients (99.4%) with a mean follow-up of 3.0 +/- 0.7 years. DAT duration was 2.8 +/- 0.4 and 5.9 +/- 0.8 months in patients with SES and PES, respectively. Adherence to continued single antiplatelet therapy was 98.4%. We identified 14 patients with definite ST (1.4%) and no patients with probable ST with a cumulative incidence of 0.6% at 30 days, of 0.8% at one year, of 1.2% at 2 years, and of 1.4% at three years. CONCLUSIONS: Definite or probable ST after DES implantation and short DAT occurs with a cumulative incidence of 1.4% at 3 years if excellent patient adherence to the continued single antiplatelet therapy can be achieved.