Faculty Bibliography

Introduction: The purpose of this study was to evaluate the performance and safety of a novel Remote Catheter System (RCS), the Amigo (Catheter Robotics, Inc., Mount Olive, NJ) in mapping the right side of the heart. Methods: The RCS consists of a mechanical robotic arm that provides an interface with commercially available EP catheters. The EP catheter can be manipulated easily using a wired remote controller, and enables the physician to manipulate the catheter to different locations in the heart with fluoroscopic guidance outside the radiation field. The RCS was studied in a nonrandomized, prospective clinical trial at 13sites (NCT01139814). The study population consisted of adults (mean age 56.6 +/- 16.4 yrs) with indication for a right sided EP procedure. The performance endpoint was to achieve 80% successful navigation to all points. The safety endpoint was an Amigo related major complication rate of less than 4%. Right femoral venous access was obtained in standard fashion, an 8F sheath was placed in the femoral vein, and EP catheter advanced to the IVC. The catheter handle was placed in the RCS and locked in position. Using the remote controller, the catheter was advanced to 8 pre-specified locations in a specific sequence: RV apex, mid right ventricularseptum, RVOT, His, CS OS, HRA, lateral tricuspid annulus and low lateral right atrium. Time to each location (< 7 minutes), location accuracy and quality of contact was confirmed by imaging and with specific criteria for electrograms and pacing thresholds. Results: In 181 patients a total of 1396/1448 locations were successfully mapped (96%) with all protocol criteria met. Overall success rate was statistically superior (one sided p-value < 0.0001)to the performance goal, and met the efficacy end point. In 1434/1448 (99%) locations, the physicians were able to successfully reach the desired points with RCS and confirm fluoroscopically. The success rate per location was > 94%for all points, and 98% of subjects were responders (6 of 8 locations successful).The RCS major complications (MC) rate was 0% which was significantly less than 4% (one sided p=0.003) goal, meeting the safety end point. Conclusions: The Amigo RCS was shown to be safe and effective in mapping the right heart chambers

Introduction The objective of this retrospective study was to investigate the relationships between fluid and vasopressor interventions and patient outcomes. In intensive care, it is imperative to resolve hypotensive episodes (HEs) in a timely manner in order to minimize end-organ damage. The current clinical practice is first to attempt fluid resuscitation and then to follow with vasopressor therapy if fluid resuscitation is unsuccessful. However, the effects of fluid and vasopressor interventions on patient outcomes have not been clearly established. Methods Hypotension was defined as MAP below 60 mmHg. The primary outcome was in-hospital mortality. Secondary outcomes included ICU LOS, HE duration, Hypotension Severity Index (HSI) (MAP curve area below 60 mmHg during the HE), and rise in serum creatinine. The patient cohort included patients in the MIMIC-II database [1] who experienced a single HE. Multivariate logistic regression and propensity score analysis were employed. Sensitivity analyses were conducted in subpopulations stratified by treatment type and diagnosis. Results A total of 3,163 patients in MIMIC-II met the inclusion criteria. The multivariate regression results showed that fluid resuscitation was significantly associated with shorter ICU LOS (OR = 0.71, P = 0.007) and greater HSI (OR = 1.26, P = 0.04). Vasopressor administration significantly decreased HE duration (OR = 0.29, P <0.001) and HSI (OR = 0.72, P = 0.002) but was correlated with increased in-hospital mortality risk (OR = 2.86, P <0.001) (even after propensity adjustment; OR = 2.44, P <0.001), prolonged ICU LOS (OR = 1.29, P = 0.04), and rise in serum creatinine (OR = 1.44, P = 0.002). Sensitivity analyses in treatmentspecific and diagnosis-specific subpopulations corroborated the relationship between vasopressors and increased in-hospital mortality. Conclusion Regarding the relationship between vasopressor therapy and in-hospital mortality, similar findings have been reported in previous studies analyzing sepsis [2], cardiac surgery [3], and heart failure [4]. We speculate that benefits of vasopressor use may be restricted to subsets of patients with specific conditions. This study illustrates the utility of electronic medical records in research when randomized controlled trials are difficult to conduct

The treatment of bifurcation lesions (BLs) is associated with high procedural complication and restenosis rates. Two techniques of BL interventions were compared: the simultaneous kissing stents (SKS) technique, involving 2 stents, 1 in the main vessel and 1 in the side branch (n = 100), and the conventional stent strategy (CSS) technique, involving a stent in the main vessel and provisional stenting for the side branch (n = 100). In-hospital and 30-day major adverse cardiac events were greater in the CSS group, with significantly less procedure time with the SKS technique. The incidence of target lesion revascularization was 5% in the SKS group and 18% in the CSS group (p = 0.007). Therefore, the SKS technique seems to be rapid, safe, and effective for the treatment of medium- to large-size BLs, with a trend toward fewer acute complications and promising mid-term results.

Pharmacologic treatment has been used for decades for conversion and prevention of recurrent atrial fibrillation (AF). But the use of antiarrhythmic drugs is associated with substantial side effects and mortality in some patients. Accordingly, it is not surprising that nonpharmacologic techniques have been developed for the management of AF, including the use of atrial defibrillators, atrial pacing methods, and several surgical and radiofrequency catheter ablation procedures. The atrial defibrillator has been found to detect and treat atrial and ventricular arrhythmias appropriately, with successful termination of spontaneous AF through low energy shocks. Although these devices are promising, the factor which limits their widespread use is not safety or efficacy, but patient comfort. Several studies suggest that atrial-based cardiac pacing may have a beneficial effect in decreasing and preventing AF episodes in patients with sick sinus syndrome. Palliative ablative procedures also available for the treatment of atrial fibrillation include AV junctional modification and AV nodal ablation with permanent pacing, the latter technique being associated with improvements in ejection fraction. Two potentially curative procedures are the surgical MAZE and endocardial catheter ablation. These techniques are based on placing strategically located lesions in the atrium to disrupt the conduction pathway(s). Recent studies have focused on ablative therapies aimed at the area of the pulmonic veins. The main therapy for maintaining sinus rhythm after conversion is predominantly pharmacologic. Similarly, in the absence of heart block, if conversion to sinus rhythm is not successful, pharmacologic modalities may be required to control ventricular rate. In any case, planning a treatment regimen for the management of AF should include evaluation of the risks inherent in the use of various drugs as well as more invasive strategies.