Optimizing mechanical circulatory support hemodynamics using coronary sinus pacing.

The role of atrioventricular (AV) dyssynchrony as a cause of low Impella device output in cardiogenic shock from acute anterior myocardial infarction (MI) responding to reestablishing AV synchrony has not been previously reported. We present, for the first time, a unique case of AV dyssynchrony causing recurrent hypotension and ventricular fibrillation in such a patient, followed by immediate return to hemodynamic stability after restoring AV synchrony. Our case also highlights the novel use of a Damato multi-polar catheter for coronary sinus pacing to achieve AV synchrony.

Short and Intermediate Term Outcomes of the Convergent Procedure: Initial Experience in a Tertiary Referral Center.

PURPOSE: The Convergent procedure is a hybrid, multidisciplinary treatment for symptomatic atrial fibrillation (AF) consisting of minimally invasive surgical epicardial ablation and percutaneous/catheter endocardial ablation. We investigated outcomes following introduction of the Convergent procedure at our institution. METHODS: Retrospective study examining single-center outcomes. Demographic, procedural, and post-procedural variables were collected with follow-up data obtained at 3, 6, and 12 months. RESULTS: In all, 36 patients with paroxysmal (11%) or persistent/long-standing persistent (89%) AF underwent the Convergent procedure. 36% also underwent concomitant left atrial appendage (LAA) exclusion by thoracoscopic placement of an epicardial clip. Mean age 60.6 ± 8.0 years with mean arrhythmia burden of 3.9 ± 2.7 years. All patients had failed prior attempts at medical management, 81% had failed prior cardioversion, and 17% had failed prior catheter ablation. Convergent was performed successfully in all patients with no peri-procedural deaths or major complications. At 3 and 12 months, 77.8% and 77.3% of patients, respectively, were free from symptomatic arrhythmia. 65.8% were off anti-arrhythmic medication at 12 months. CONCLUSIONS: The Convergent procedure is safe and has good short- and intermediate-term clinical success rates. This unique hybrid approach combines strengths of surgical and catheter ablation and should be part of any comprehensive AF treatment program.

Traumatic Ventricular Septal Defect Resulting from a Motor Vehicle Collision.

This case report describes a rare case of ventricular septal defect due to non-penetrating trauma in a 43 year old male involved in a motor vehicle collision. The diagnosis was made by echocardiogram and the patient was taken immediately to the operating room for emergent surgical repair of the ventricular septal defect and survived.

Cryoablation for the Treatment of Drug Refractory Symptomatic Atrial Fibrillation: A Regional Medical Center Experience.

INTRODUCTION: PVI is an effective, guideline-based treatment for drug refractory symptomatic AF. Balloon cryoablation has been shown to be a safe and effective method for PVI. In the STOP-AF trial, data was produced from practitioners performing PVI with significant experience at high volume centers. This study evaluates the effectiveness and safety of treating symptomatic, drug refractory AF with PVI via cryoablation after implementation in a regional medical center. METHOD: This represents a retrospective analysis of outcomes after cryoablation treatment for AF in 71 patients over 354.7 +/- 164.4 days. Reported and recorded episodes of AF were categorized into a representative percent of AF "burden" for each 90 day period. Primary effectiveness and safety end points paralleled those of the STOP-AF trial. RESULTS: Patients undergoing cryoablation had a 91% reduction of AF burden at 6 months following the procedure with an event-free survival rate of 45.5 % at a mean follow up of 12 months. The mean burden reduction was 3.21% per quarter. Anti-arrhythmic and anticoagulant medication use was reduced by 14.3% and 26.8% respectively. Significant complications included one report of pulmonary vein stenosis, one report of pseudoaneurysm and 5.5% of patients had transient pericarditis or pericardial effusion following the procedure. CONCLUSION: The results of this study were comparable to those of the high volume multi-center STOP-AF trial. PVI via cryoablation is a safe and effective alternative treatment of drug refractory symptomatic AF in the setting of a regional medical center.

Need for an improved submission process for listing drugs for reimbursement in Canadian provinces.

BACKGROUND: To have a drug listed in a province's formulary, manufacturers must submit an application providing data required by the provincial rules and guidelines. The procedures for the scientific evaluation of drugs considered for listing for reimbursement in five provinces have been examined previously. OBJECTIVE: The present study investigates the clarity of the same five provinces' rules and guidelines about effectiveness and cost data that should be included in listing submissions from the perspective of the pharmaceutical company. METHODS: The manufacturers of five recently introduced drugs selected by the investigators received questionnaires asking about the departments within their companies that are responsible for the submission, the data required by each of the five provinces and the clarity of each province's requirements for submission. Each company was also asked similar questions about its own submission experience with its drug. Investigators visited each manufacturer to review the questionnaires and answer questions. RESULTS: The manufacturers perceived the rules and guidelines on effectiveness and economic data of several provinces as being neither clear nor consistent. Consequently, information that companies submit in their attempts at compliance with the rules and guidelines varies substantially. CONCLUSIONS: The manufacturers' perceptions of the information required by the provinces on effectiveness and cost information were inconsistent. Previous work indicated that the provinces make significant decisions about listings based on inadequate information resulting in a scientifically flawed system that contributes to considerable inequality in access to new drugs between provinces. The findings of the present work reinforce this conclusion.

"Cost-effectiveness" estimates result in flawed decision-making in listing drugs for reimbursement.

BACKGROUND: Facing financial pressures, the provinces and territories have chosen to use "cost-effectiveness" for making decisions about drug listings. This study examines the scientific basis for the procedures used to determine cost-effectiveness in 5 Canadian provinces. METHODS: Questionnaires were mailed to key provincial informants asking about the respondent's expertise and role, the administrative and scientific basis for decision-making, organizational structures and other factors in the scientific evaluation and decision-making process, and the transparency of the process. There were also questions about the data required and received and their importance, the place of cost-effectiveness and other economic impact evaluations, the data sources for them, and the use of follow-up monitoring to evaluate the decisions made. RESULTS: Information required by the provinces for decision-making about cost-effectiveness is not available to them at the time of their decisions about listing new medications. The primary sources of data on both efficacy and cost-effectiveness are pharmaceutical companies. Efficacy information is generated in a scientifically rigorous manner, whereas the effectiveness and cost data are estimates potentially subject to biases and evaluated by judgement (expert opinion) alone. Moreover, there is no collaboration in the assessment process between provinces. The outcomes are large differences between provinces in the decisions made and, hence, in the pharmaceuticals accessible to residents. CONCLUSIONS: Current methods for making decisions about provincial drug listings are based on inadequate data, and the lack of consistency in the provinces' decisions suggest they may be scientifically flawed. We recommend establishing a single national scientific review committee, with re-evaluation of each drug's cost-effectiveness after a suitable period of monitored use.