Competitive bidding for interventional cardiology supplies: lessons learned during round 2.

OBJECTIVE: To assess the magnitude of savings and develop concepts for "best strategies" in reducing costs in the purchasing of high-technology, high-cost materials used in coronary interventions and electrophysiologic treatments. STUDY DESIGN: Observational experience in competitive bidding for defibrillators, pacemakers, coronary stents, and coronary balloon catheters at a large, midwestern, publicly owned, academic cardiovascular center. METHODS: Iterative negotiation following a broad request for proposal sent to a diverse group of vending organizations in high-technology areas of cardiology. Product costs and volume usage were assessed before and after the process to estimate annualized cost reduction achieved. RESULTS: Using a combination of identification of preferred vendors; consignment of supplies; and collaborative consensus among physicians, administration, materials management, purchasing, and vendors, an annualized savings of more than $1.3 million was achieved. CONCLUSIONS: Aggressive, collaborative, fair, and competitive bidding for high-cost products used for coronary interventions and electrophysiologic treatments leads to substantial cost savings and can promote provider-industry partnerships that further enhance product use, provision, and tracking.

Relationship between serum potassium concentration and risk of recurrent ventricular tachycardia or ventricular fibrillation.

INTRODUCTION: Electrolyte abnormalities are considered a correctable cause of a life-threatening ventricular arrhythmia according to American Heart Association/American College of Cardiology Practice Guidelines, and ventricular tachycardia or ventricular fibrillation in the setting of an electrolyte abnormality is considered a class III indication for defibrillator implantation. However, there are little data to support this recommendation. The purpose of this study was to determine the risk of a recurrent sustained ventricular arrhythmia in patients with a low serum potassium concentration at the time of an initial episode of a sustained ventricular arrhythmia. METHODS AND RESULTS: One hundred sixty-nine consecutive patients who presented with a sustained ventricular arrhythmia and a serum potassium concentration determined on the day of the arrhythmia underwent defibrillator implantation. All patients had structural heart disease and left ventricular ejection fraction of 0.32+/-0.15. On the day of the index arrhythmia, 30% of the patients had a serum potassium concentration <3.5 or >5.0 mEq/L, including 7% who had a serum potassium concentration <3.0 or >6.0 mEq/L. For the entire cohort of patients, freedom from a recurrent sustained ventricular arrhythmia was 18% at 5 years and was not significantly different among patients with a serum potassium concentration <3.5 mEq/L (23%), between 3.5 and 5.0 mEq/L (16%), and >5.0 mEq/L (5%; P = 0.1). CONCLUSION: The results of the present study suggest that patients with structural heart disease and an abnormal serum potassium concentration at the time of an initial episode of sustained ventricular tachycardia or ventricular fibrillation are at high risk for a recurrent ventricular arrhythmia; therefore, implantable defibrillator therapy may be reasonable.

Differentiation of atypical atrioventricular node re-entrant tachycardia from orthodromic reciprocating tachycardia using a septal accessory pathway by the response to ventricular pacing.

OBJECTIVES: The purpose of this study was to determine whether the response to ventricular pacing during tachycardia is useful for differentiating atypical atrioventricular node re-entrant tachycardia (AVNRT) from orthodromic reciprocating tachycardia (ORT) using a septal accessory pathway. BACKGROUND: Although it is usually possible to differentiate atypical AVNRT from ORT using a septal accessory pathway, a definitive diagnosis is occasionally elusive. METHODS: In 30 patients with atypical AVNRT and 44 patients with ORT using a septal accessory pathway, the right ventricle was paced at a cycle length 10 to 40 ms shorter than the tachycardia cycle length (TCL). The ventriculo-atrial (VA) interval and TCL were measured just before pacing. The interval between the last pacing stimulus and the last entrained atrial depolarization (stimulus-atrial [S-A] interval) and the post-pacing interval (PPI) at the right ventricular apex were measured on cessation of ventricular pacing. RESULTS: All 30 patients with atypical AVNRT and none of the 44 patients with ORT using a septal accessory pathway had an S-A-VA interval >85 ms and PPI-TCL >115 ms. CONCLUSIONS: The S-A-VA interval and PPI-TCL are useful in distinguishing atypical AVNRT from ORT using a septal accessory pathway.

Should an abnormal serum potassium concentration be considered a correctable cause of cardiac arrest?

According to American Heart Association/American College of Cardiology Practice Guidelines, electrolyte abnormalities, including abnormal serum potassium concentrations, are considered a correctable cause of a life-threatening ventricular arrhythmia. Ventricular defibrillator therapy in this situation is a class III indication, and thought to be ineffective and perhaps harmful, although there are minimal data to support this recommendation. The steady-state serum potassium concentration frequently changes during a cardiac arrest. Additionally, the vast majority of cardiac arrest patients have structural heart disease and are commonly treated with a variety of medications that can alter the serum potassium concentration. In the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial, patients with a correctable cause of an electrolyte imbalance were excluded from study participation but were followed in the AVID registry. Similar outcomes were observed among patients in the AVID registry and the main trial. Spironolactone therapy in patients with congestive heart failure decreases all-cause mortality and sudden and nonsudden cardiac death. In a preliminary study of 169 patients with an episode of a sustained ventricular arrhythmia treated with an implantable defibrillator, freedom from appropriate defibrillator therapy was 18% after five years. The probability of appropriate defibrillator therapy was independent of the initial serum potassium concentration. For these reasons, our current clinical practice is to use an implantable defibrillator to treat an initial episode of sustained ventricular tachycardia or ventricular fibrillation that occurs in a patient with structural heart disease and an abnormal serum potassium concentration.

Effect of gender on atrial electrophysiologic changes induced by rapid atrial pacing and elevation of atrial pressure.

INTRODUCTION: The incidence of atrial fibrillation is greater in men than in women, but the reasons for this gender difference are unclear. The purpose of this study was to evaluate the effects of gender on the atrial electrophysiologic effects of rapid atrial pacing and an increase in atrial pressure. METHODS AND RESULTS: Right atrial pressure and effective refractory period (ERP) were measured during sinus rhythm and during atrial and simultaneous AV pacing at a cycle length of 300 msec in 10 premenopausal women, 11 postmenopausal women, and 24 men. The postmenopausal women were significantly older than the premenopausal women (61 +/- 8 years vs 34 +/- 10 years; P < 0.01). During sinus rhythm, mean atrial ERP in premenopausal women was shorter (211 +/- 19 msec) than in postmenopausal women and age-matched men (242 +/- 18 msec and 246 +/- 34 msec, respectively; P < 0.05). Atrial ERPs in all patients shortened significantly during atrial and simultaneous AV pacing. However, the degree of shortening during atrial pacing (43 +/- 8 msec vs 70 +/- 20 msec and 74 +/- 21 msec; P < 0.05) and during simultaneous AV pacing (48 +/- 16 msec vs 91 +/- 27 msec and 84 +/- 26 msec; P < 0.05) was significantly less in premenopausal women than in postmenopausal women or age-matched men. CONCLUSION: The results of this study demonstrate a significant gender difference in atrial electrophysiologic changes in response to rapid atrial pacing and an increase in atrial pressure. The effect of menopause on the observed changes suggests that the gender differences may be mediated by the effects of estrogen on atrial electrophysiologic properties.

Double potentials along the ablation line as a guide to radiofrequency ablation of typical atrial flutter.

OBJECTIVES: The purpose of this study was to determine the characteristics of double potentials (DPs) that are helpful in guiding ablation within the cavo-tricuspid isthmus. BACKGROUND: Double potentials have been considered a reliable criterion of cavo-tricuspid isthmus block in patients undergoing radiofrequency ablation of typical atrial flutter (AFL). However, the minimal degree of separation of the two components of DPs needed to indicate complete block has not been well defined. METHODS: Radiofrequency ablation was performed in 30 patients with isthmus-dependent AFL. Bipolar electrograms were recorded along the ablation line during proximal coronary sinus pacing at sites at which radiofrequency ablation resulted in incomplete or complete isthmus block. RESULTS: Double potentials were observed at 42% of recording sites when there was incomplete isthmus block, compared with 100% of recording sites when the block was complete. The mean intervals separating the two components of DPs were 65 +/- 21 ms and 135 +/- 30 ms during incomplete and complete block, respectively (p < 0.001). An interval separating the two components of DPs (DP(1-2) interval) <90 ms was always associated with a local gap, whereas a DP(1-2) interval > or =110 ms was always associated with local block. When the DP(1-2) interval was between 90 and 110 ms, an isoelectric segment within the DP and a negative polarity in the second component of the DP were helpful in indicating local isthmus block. A DP(1-2) interval > or =90 ms with a maximal variation of 15 ms along the entire ablation line was an indicator of complete block in the cavo-tricuspid isthmus. CONCLUSIONS: Detailed analysis of DPs is helpful in identifying gaps in the ablation line and in distinguishing complete from incomplete isthmus block in patients undergoing radiofrequency ablation of typical AFL.

Incidence and clinical significance of inducible atrial tachycardia in patients with atrioventricular nodal reentrant tachycardia.

INTRODUCTION: The purpose of this prospective study was to determine the prevalence and clinical significance of inducible atrial tachycardia in patients undergoing slow pathway ablation for AV nodal reentrant tachycardia who did not have clinically documented episodes of atrial tachycardia. METHODS AND RESULTS: Twenty-seven (15%) of 176 consecutive patients who underwent slow pathway ablation for AV nodal reentrant tachycardia were found to have inducible atrial tachycardia with a mean cycle length of 351+/-95 msec. The atrial tachycardia was sustained in 7 (26%) of 27 patients and was isoproterenol dependent in 20 patients (74%). The atrial tachycardia was not ablated or treated with medications, and the patients were followed for 9.7+/-5.8 months. Six (22%) of the 27 patients experienced recurrent palpitations during follow-up. In one patient each, the palpitations were found to be due to sustained atrial tachycardia, nonsustained atrial tachycardia, recurrence of AV nodal reentrant tachycardia, paroxysmal atrial fibrillation, sinus tachycardia, and frequent atrial premature depolarizations. Thus, only 2 (7%) of 27 patients with inducible atrial tachycardia later developed symptoms attributable to atrial tachycardia. CONCLUSION: Atrial tachycardia may be induced by atrial pacing in 15% of patients with AV nodal reentrant tachycardia. Because the vast majority of patients do not experience symptomatic atrial tachycardia during follow-up, treatment for atrial tachycardia should be deferred and limited to the occasional patient who later develops symptomatic atrial tachycardia.

Electrogram polarity and cavotricuspid isthmus block during ablation of typical atrial flutter.

INTRODUCTION: The atrial activation sequence around the tricuspid annulus has been used to assess whether complete block has been achieved across the cavotricuspid isthmus during radiofrequency ablation of typical atrial flutter. However, sometimes the atrial activation sequence does not clearly establish the presence or absence of complete block. The purpose of this study was to determine whether a change in the polarity of atrial electrograms recorded near the ablation line is an accurate indicator of complete isthmus block. METHODS AND RESULTS: Radiofrequency ablation was performed in 34 men and 10 women (age 60 +/- 13 years [mean +/- SD]) with isthmus-dependent, counterclockwise atrial flutter. Electrograms were recorded around the tricuspid annulus using a duodecapolar halo catheter. Electrograms recorded from two distal electrode pairs (E1 and E2) positioned just anterior to the ablation line were analyzed during atrial flutter and during coronary sinus pacing, before and after ablation. Complete isthmus block was verified by the presence of widely split double electrograms along the entire ablation line. Complete bidirectional isthmus block was achieved in 39 (89%) of 44 patients. Before ablation, the initial polarity of E1 and E2 was predominantly negative during atrial flutter and predominantly positive during coronary sinus pacing. During incomplete isthmus block, the electrogram polarity became reversed either only at E2, or at neither E1 nor E2. In every patient, the polarity of E1 and E2 became negative during coronary sinus pacing only after complete isthmus block was achieved. In 4 patients (10%), the atrial activation sequence recorded with the halo catheter was consistent with complete isthmus block, but the presence of incomplete block was accurately detected by inspection of the polarity of E1 and E2. CONCLUSION: Reversal of polarity in bipolar electrograms recorded just anterior to the line of isthmus block during coronary sinus pacing after ablation of atrial flutter is a simple, quick, and accurate indicator of complete isthmus block.

P wave polarity during pacing in pulmonary veins.

INTRODUCTION: Recent studies have demonstrated that premature depolarizations that trigger atrial fibrillation often arise in pulmonary veins. The purpose of this study was to evaluate whether P wave polarity is helpful in distinguishing which of the 4 pulmonary veins is the site of origin of a premature depolarization. METHODS AND RESULTS: In 28 patients without structural heart disease who underwent focal ablation of paroxysmal atrial fibrillation, P wave polarity on a 12-lead electrocardiogram (ECG) was analyzed during sinus rhythm, and during pacing at a cycle length of 500--600 ms in the high right atrium and within each of the 4 pulmonary veins. P waves were categorized as positive, negative, biphasic or isoelectric. A negative or biphasic P wave in lead I (sensitivity 85 %, specificity 71 %) or a positive P wave in V1 (sensitivity 85 %, specificity 89 %) were helpful in predicting a pulmonary venous site of origin as opposed to a right atrial site of origin. A positive P wave in lead II and III distinguished superior from inferior pulmonary veins (sensitivity 90 %, specificity 84 %). The sensitivity and specificity of negative or biphasic P waves in lead aVL in distinguishing a left from right pulmonary vein site of origin were 94 % and 42 %, respectively. CONCLUSIONS: Analysis of P waves polarity may be helpful in localizing the pulmonary vein that is the site of origin of a premature depolarization. Among the 12 ECG leads, I, II, III, aVL, and V1 are the most helpful in regionalizing premature depolarizations arising in the pulmonary veins.

Physician interpretation of electrocardiographic artifact that mimics ventricular tachycardia.

BACKGROUND: Patients who are misdiagnosed with ventricular tachycardia because of electrocardiographic artifact may be subjected to unnecessary procedures. The purpose of this study was to determine how often electrocardiographic artifact is misdiagnosed as ventricular tachycardia. METHODS: Physicians (n = 766) were surveyed with a case simulation that included a two-lead electrocardiographic monitor tracing of artifact simulating a wide-complex tachycardia. RESULTS: The rhythm strip was not recognized as artifact by 52 of the 55 internists (94%), 128 of the 221 cardiologists (58%), and 186 of the 490 electrophysiologists (38%). One hundred fifty-six of the 181 electrophysiologists (88%), 67 of the 126 cardiologists (53%), and 14 of the 15 internists (31%) who misdiagnosed the rhythm as ventricular tachycardia recommended an invasive procedure for further evaluation or therapy. CONCLUSIONS: This physician survey suggests that electrocardiographic artifact that mimics ventricular tachycardia may frequently result in patients being subjected to unnecessary invasive cardiac procedures. Physicians should include artifact in their differential diagnosis of wide complex tachycardias to minimize unneeded procedures.

Prevalence of central venous occlusion in patients with chronic defibrillator leads.

BACKGROUND: Many patients with previously implanted ventricular defibrillators are candidates for an upgrade to a device capable of atrial-ventricular sequential or multisite pacing. The prevalence of venous occlusion after placement of transvenous defibrillator leads is unknown. The purpose of this study was to determine the prevalence of central venous occlusion in asymptomatic patients with chronic transvenous defibrillator leads. METHODS: Thirty consecutive patients with a transvenous defibrillator lead underwent bilateral contrast venography of the cephalic, axillary, subclavian, and brachiocephalic veins as well as the superior vena cava before an elective defibrillator battery replacement. The mean time between transvenous defibrillator lead implantation and venography was 45 +/- 21 months. Sixteen patients had more than 1 lead in the same subclavian vein. No patient had clinical signs of venous occlusion. RESULTS: One (3%) patient had a complete occlusion of the subclavian vein, 1 (3%) patient had a 90% subclavian vein stenosis, 2 (7%) patients had a 75% to 89% subclavian stenosis, 11 (37%) patients had a 50% to 74% subclavian stenosis, and 15 (50%) patients had no subclavian stenosis. CONCLUSIONS: The low prevalence of subclavian vein occlusion or severe stenosis among defibrillator recipients found in this study suggests that the placement of additional transvenous leads in a patient who already has a ventricular defibrillator is feasible in a high percentage of patients (93%).

Role of transisthmus conduction intervals in predicting bidirectional block after ablation of typical atrial flutter.

INTRODUCTION: Complete bidirectional cavotricuspid isthmus block is the endpoint for ablation of typical atrial flutter. The purpose of this study was to determine whether the extent of prolongation of the transisthmus interval after ablation predicts complete bidirectional block. METHODS AND RESULTS: Fifty-seven consecutive patients underwent 60 ablation procedures for isthmus-dependent atrial flutter. The clockwise and counterclockwise transisthmus intervals were determined before and after ablation during pacing from the low lateral right atrium and the coronary sinus. Bidirectional block was achieved with ablation in 55 (96%) of 57 patients. The transisthmus intervals before ablation and after complete transisthmus block were 100.3 +/- 21.1 msec and 195.8 +/- 30.1 msec, respectively, in the clockwise direction (P < 0.0001), and 98.2 +/- 24.7 msec and 185.7 +/- 33.9 msec, respectively, in the counterclockwise direction (P < 0.0001). An increase in the transisthmus interval by > or = 50% in both directions after ablation predicted complete bidirectional block with 100% sensitivity and 80% specificity. The positive and negative predictive values were 89% and 100%, respectively. The diagnostic accuracy of a > or = 50% prolongation in the transisthmus interval was 92%. CONCLUSION: Prolongation of the transisthmus interval by > or = 50% in the clockwise and counterclockwise directions is associated with a high degree of diagnostic accuracy and an excellent negative predictive value in determining complete bidirectional transisthmus block. This may be a useful and simple adjunctive criterion for assessment of complete transisthmus conduction block.

Complete atrioventricular block after valvular heart surgery and the timing of pacemaker implantation.

The natural history of patients who developed complete atrioventricular block after valvular heart surgery was investigated to determine the optimal timing for pacemaker implantation. Patients who developed complete atrioventricular block within 24 hours after operation, which then persisted for > 48 hours, were unlikely to recover; such patients could potentially undergo earlier pacemaker implantation if otherwise ready for discharge.

Effects of simultaneous atrioventricular pacing on atrial refractoriness and atrial fibrillation inducibility: role of atrial mechanoelectrical feedback.

INTRODUCTION: The purpose of this study was to evaluate the effects of an acute increase in atrial pressure on refractoriness (mechanoelectrical feedback) and the vulnerability to atrial fibrillation (AF) and to investigate the effects of autonomic blockade and verapamil on mechanoelectrical feedback in humans. METHODS AND RESULTS: Right atrial pressure and effective refractory period (ERP) at the right atrial appendage (RAA) and high right atrial septum were measured during sinus rhythm, and during atrial and simultaneous AV pacing at a cycle length of 300 msec, either in the absence (n = 25) or presence (n = 22) of pharmacologic autonomic blockade. In another 15 patients, the protocol was performed before and after infusion of verapamil 0.15 mg/kg. In the absence of autonomic blockade, AV pacing resulted in a higher mean right atrial pressure (11.7 +/- 3.3 vs 4.3 +/- 3.0 mmHg, P < 0.001) and a shorter atrial RAA ERP (144 +/- 23 msec vs 161 +/- 21 msec; P < 0.001) compared with atrial pacing; AF was induced more often during AV pacing (87%) than during atrial pacing (20%) and was related directly to the right atrial pressure (r = 0.39, P = 0.004) and indirectly to the RAA ERP (r = -0.42, P < 0.001). The susceptibility to sustained AF was greatly enhanced by autonomic blockade. Verapamil markedly attenuated the shortening of ERP and the propensity for AF that occurred during simultaneous AV pacing. CONCLUSION: An acute increase in atrial pressure during tachycardia is associated with shortening of atrial refractoriness and a propensity for AF, i.e., atrial mechanoelectrical feedback, which may be enhanced by autonomic blockade and attenuated by calcium channel blockade.

Effect of ethanol on defibrillation energy requirements in humans.

The purpose of this double-blind study was to determine the effect of intravenous ethanol administration on defibrillation efficacy in 18 patients with an implantable defibrillator. The equivalent of 60 ml of 100 proof ethanol did not impair defibrillation efficacy.

Effects of digoxin on acute, atrial fibrillation-induced changes in atrial refractoriness.

BACKGROUND: Atrial fibrillation (AF) shortens the atrial effective refractory period (ERP) and predisposes to further episodes of AF. The acute changes in atrial refractoriness may be related to tachycardia-induced intracellular calcium overload. The purpose of this study was to determine whether digoxin, which increases intracellular calcium, potentiates the acute effects of AF on atrial refractoriness in humans. METHODS AND RESULTS: In 38 healthy adults, atrial ERP was measured at basic drive cycle lengths (BDCLs) of 350 and 500 ms after autonomic blockade. Nineteen patients had been treated with digoxin for 2 weeks. After a several-minute episode of AF, atrial ERP was measured serially at alternating BDCLs. Compared with pre-AF ERPs, the first post-AF ERPs were significantly shorter in both the digoxin and the control groups (P:<0.001). The post-AF ERP at a BDCL of 350 ms shortened to a greater degree in the digoxin group (37+/-16 ms) than in the control group (20+/-13 ms, P:<0.001); similar changes occurred at a BDCL of 500 ms. During post-AF determinations of the atrial ERP, secondary AF episodes occurred significantly more often in the digoxin group (32% versus 16%; P:<0. 04). CONCLUSIONS: After a brief episode of AF, digoxin augments the shortening that occurs in atrial refractoriness and predisposes to the reinduction of AF. These effects occur in the setting of autonomic blockade and therefore are more likely to be due to the effects of digoxin on intracellular calcium than to its vagotonic effects.

Transvenous biventricular defibrillation.

The recent success of biventricular pacing with transvenously implantable left ventricular leads suggests that left ventricular leads may be useful for other modes of therapy. Animal studies showed small leads inserted into a left ventricular vein dramatically reduced defibrillation strength requirements. This article describes a human investigation of the feasibility of biventricular defibrillation. Fifty-one patients undergoing implantable cardioverter defibrillator (ICD) implantation were enrolled. After insertion of a standard ICD lead, a prototype over-the-wire left ventricular defibrillation lead was inserted through the coronary sinus and into a vein on the left ventricle. Lead insertion was guided by retrograde venography. The left ventricular lead's location was randomized to the anterior or posterior vein. Randomized, paired defibrillation threshold (DFT) testing was performed to compare a standard ICD shock configuration (Control: right ventricle- --> superior vena cava+ + CAN+) to 1 of 3 biventricular shock configurations. In the anterior vein, the left ventricular lead was tested with either a single biphasic shock from right ventricle + left ventricle- --> superior vena cava+ + CAN+ or a dual biphasic shock. In the posterior vein, the left ventricular lead was tested with a dual biphasic shock. Dual shocks consisted of a 40% tilt biphasic shock from right ventricle- --> superior vena cava+ + CAN+ followed by another 40% tilt biphasic shock from left ventricle- --> superior vena cava+ + CAN+, delivered from a single 225 microF capacitance. Left ventricular lead positioning was successful in 41 of 46 patients (89%). Mean left ventricular lead insertion time was 17 +/- 17 minutes and 13 +/- 15 minutes for anterior and posterior locations, respectively. Mean DFTs were not statistically lower for the left ventricular shock configurations, but retrospective analysis showed a well-defined region of the posterolateral left ventricle where consistent DFT reduction was achieved with dual shocks (14.0 +/- 2.7 J vs 7.8 +/- 0.9 J; n = 5; p = 0.04). There were no adverse events requiring intervention due to the use of the left ventricular lead. Biventricular defibrillation is feasible and safe under the conditions used in this study. Additional studies are needed to verify whether dual shocks with posterolateral left ventricular lead positions consistently reduce DFTs.