Prospective validation of stress echocardiography as an identifier of cardiac resynchronization therapy responders.

BACKGROUND: Cardiac resynchronization therapy (CRT) provides benefit for congestive heart failure (CHF), but predictors of the clinical response are debated. OBJECTIVE: The aim of this prospective study was to assess the predictive role of dobutamine stress echocardiography (DSE) in identifying a suitable candidate for CRT. METHODS: From March 2001 to December 2003, 71 CHF patients were prospectively enrolled on the basis of four criteria: New York Heart Association (NYHA) class III and IV; QRS > or =150 ms with a left bundle branch block pattern, and left ventricular ejection fraction (LVEF) < or =35% under optimal medical treatment. The combined endpoints were hospital readmission for class IV CHF, heart transplant (HT), and CHF-related death. RESULTS: The 67 patients completing the study presented with the following characteristics: age (70 +/- 10 years; 11 women); etiology (idiopathic in 44, ischemic in 23); NYHA class (40 in class III and 27 in class IV); LVEF 26% (+/-5%); QRS duration (190 +/- 28 ms); 6-minute walk test 330 m (+/-108); peak oxygen uptake 10.7 (+/-3.3 mL/kg/min); mitral insufficiency in 42 (> or =III grade); interventricular (IV) delay (62 +/- 21 ms); and intraventricular dyssynchrony in 30 patients. Over the follow-up period of 12.1 +/- 8.7 months, 20 (29.9%) of 67 patients presented with at least one hemodynamic event: hospitalization for CHF in 19 (28%) of 67, HT in 2 (3%) of 67, and CHF death in 7 (10%) 67. Univariate analysis identified NYHA class (P = .03), LVEF (P = .015), IV dyssynchrony before (P = .038) and after CRT (P = .0035), IV delay after CRT (P = .002), 6-minute walk distance (P = .01), and DSE Res+ (P = .008) as significant predictors of clinical events. A receiver operating curve established a cut-off value of 1.25 for the DSE responders (Res+: 34 patients at 10 microg/kg/min infusion rates), and the improvement at the 10 microg/kg/min level was 41% +/- 7% in Res+ and 29% +/- 8% in nonresponders (P<.0001). With a cut-off value of 1.25-fold the LVEF increase, the DSE test exhibits 70% sensitivity, 61.7% specificity, 43.8% positive predictive value, and 82.9% negative predictive value. Cox analysis identified IV dyssynchrony before CRT (P = .01) and DSE Res+ (P = .003) as independent predictive factors. CONCLUSIONS: Independent predictive factors of severe hemodynamic clinical outcome in patients with CRT are IV dyssynchrony and DSE.

Simplified cardiac resynchronization implantation technique involving right access and a triple-guide/single introducer approach.

BACKGROUND: Biventricular pacing is useful for patients with congestive heart failure but has the disadvantage of being a long, user-dependent, highly technical procedure. OBJECTIVES: The purpose of this study was to simplify the procedure. The simplified technique consists of sinus (CS) venography prior to implantation, direct coronary access for the left ventricular (LV) lead without use of a left-heart delivery system, and triple-guide/one introducer cephalic vein access as the first approach in patients presenting in sinus rhythm. METHODS: A cephalic cutdown was performed, and a steerable hydrophilic guidewire was introduced in the cephalic vein. A 9Fr introducer was advanced over the guidewire, and two other guides were inserted through the introducer. This technique allowed for insertion of a right ventricular lead, an LV lead, and an atrial lead. RESULTS: One hundred three patients were evaluated from January 2002 to September 2004. Four implants failed (3.9%). The 7Fr LV lead was successfully placed in 99 of 103 patients (96.1%) directly via the 9Fr introducer, without use of a dedicated left-heart delivery system. The final position was lateral in 59 patients, posterolateral in 33, posterior in 4, and anterolateral in 3. Sixty patients were in sinus rhythm, 13 were in atrial fibrillation, and 26 had a previous pacemaker (n = 21) or defibrillator (n = 5). Triple cephalic vein access was possible in 48 of the patients in sinus rhythm (80%). Procedure parameters were as follows: LV threshold 0.9 +/- 0.7 V, LV wave amplitude 15 +/- 8 mV, LV impedance 790 +/- 232 Omega, skin-to-skin procedure time 76 +/- 33 minutes, and fluoroscopy time 23 +/- 19 minutes. Ten complications (10.1%) occurred: 7 lead dislodgments (3 within 48 hours and 4 within 6 months) requiring repositioning (7.1%), 1 subacute local infection requiring explantation (1%), 1 phrenic nerve stimulation (1%), and 1 pneumothorax (1%). The long-term success of biventricular pacing was 93.1%. CONCLUSIONS: This study demonstrates that cardiac resynchronization therapy implantation can be simplified with the combined use of a steerable hydrophilic guidewire, three guides, and one introducer via a right cephalic vein, without use of a left-heart delivery system. The triple cephalic vein approach yields an 80% implant success rate for patients in sinus rhythm. The long-term success of biventricular pacing was 93.1%.