Are patients with renal failure good candidates for percutaneous coronary revascularization in the new device era?

BACKGROUND: Patients with end-stage renal disease undergoing conventional balloon angioplasty have reduced procedural success and increased complication rates. This study was designed to determine the immediate and long-term outcomes of patients with varying degrees of renal failure undergoing percutaneous coronary intervention in the current device era. METHODS AND RESULTS: We compared the immediate and long-term outcomes of 362 renal failure patients (creatinine >1.5 mg/dL) with those of 2972 patients with normal renal function who underwent percutaneous coronary intervention between 1994 and 1997. Patients with renal failure were older and had more associated comorbidities. They had reduced procedural success (89.5% versus 92.9%, P:=0.007) and greater in-hospital combined major event (death, Q-wave myocardial infarction, emergent CABG; 10.8% versus 1.8%; P:<0.0001) rates. Renal failure was an independent predictor of major adverse cardiac events (MACEs) (OR, 3.41; 95% CI, 1.84 to 6.22; P:<0.00001). Logistic regression analysis identified shock, peripheral vascular disease, balloon angioplasty strategy, and unstable angina as independent predictors of in-hospital MACEs in the renal group. Compared with 362 age- and sex-matched patients selected from the control group, patients with renal failure had a lower survival rate (27.7% versus 6.1%, P:<0.0001) and a greater MACE rate (51% versus 33%, P:<0.001) at long-term follow-up. Cox regression analysis identified age and PTCA strategy as independent predictors of long-term MACEs in the renal group. Finally, within the renal failure population, the dialysis and nondialysis patients experienced remarkably similar immediate and long-term outcomes. CONCLUSIONS: Although patients with renal failure can be treated with a high procedural success rate in the new device era, they have an increased rate of major events both in hospital and at long-term follow-up. Nevertheless, utilization of stenting and debulking techniques improves immediate and long-term outcomes.

Mitral balloon valvotomy for patients with mitral stenosis in atrial fibrillation: immediate and long-term results.

OBJECTIVES: The purpose of this study was to examine the effect of atrial fibrillation (AF) on the immediate and long-term outcome of patients undergoing percutaneous mitral balloon valvuloplasty (PMV). BACKGROUND: There is controversy as to whether the presence of AF has a direct negative effect on the outcome after PMV. METHODS: The immediate procedural and the long-term clinical outcome after PMV of 355 patients with AF were prospectively collected and compared with those of 379 patients in normal sinus rhythm (NSR). RESULTS: Patients with AF were older (62 +/- 12 vs. 48 +/- 14 years; p < 0.0001) and presented more frequently with New York Heart Association (NYHA) class IV (18.3% vs. 7.9%; p < 0.0001), echocardiographic score >8 (40.1% vs. 25.1%; p < 0.0001), calcified valves under fluoroscopy (32.4% vs. 18.8%, p < 0.0001) and with history of previous surgical commissurotomy (21.7% vs. 16.4%; p = 0.0002). In patients with AF, PMV resulted in inferior immediate and long-term outcomes, as reflected in a smaller post-PMV mitral valve area (1.7 +/- 0.7 vs. 2 +/- 0.7 cm2; p < 0.0001) and a lower event free survival (freedom of death, redo-PMV and mitral valve surgery) at a mean follow-up time of 60 months (32% vs. 61%; p < 0.0001). In the group of patients in AF, severe post-PMV mitral regurgitation (> or =3+) (p = 0.0001), echocardiographic score >8 (p = 0.004) and pre-PMV NYHA class IV (p = 0.046) were identified as independent predictors of combined events at follow-up. CONCLUSIONS: Patients with AF have a worse immediate and long-term outcomes after PMV. However, the presence of AF by itself does not unfavorably influence the outcome, but is a marker for clinical and morphologic features associated with inferior results after PMV.

Optimal coronary balloon angioplasty with provisional stenting versus primary stent (OCBAS): immediate and long-term follow-up results.

OBJECTIVE: This study sought to compare two strategies of revascularization in patients obtaining a good immediate angiographic result after percutaneous transluminal coronary angioplasty (PTCA): elective stenting versus optimal PTCA. A good immediate angiographic result with provisional stenting was considered to occur only if early loss in minimal luminal diameter (MLD) was documented at 30 min post-PTCA angiography. BACKGROUND: Coronary stenting reduces restenosis in lesions exhibiting early deterioration (>0.3 mm) in MLD within the first 24 hours (early loss) after successful PTCA. Lesions with no early loss after PTCA have a low restenosis rate. METHODS: To compare angiographic restenosis and target vessel revascularization (TVR) of lesions treated with coronary stenting versus those treated with optimal PTCA, 116 patients were randomized to stent (n=57) or to optimal PTCA (n=59). After randomization in the PTCA group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting). RESULTS: Baseline demographic and angiographic characteristics were similar in both groups of patients. At 7.6 months, 96.6% of the entire population had a follow-up angiographic study: 98.2% in the stent and 94.9% in the PTCA group. Immediate and follow-up angiographic data showed that acute gain was significantly higher in the stent than in the PTCA group (1.95 vs. 1.5 mm; p < 0.03). However, late loss was significantly higher in the stent than the PTCA group (0.63+/-0.59 vs. 0.26+/-0.44, respectively; p=0.01). Hence, net gain with both techniques was similar (1.32< or =0.3 vs. 1.24+/-0.29 mm for the stent and the PTCA groups, respectively; p=NS). Angiographic restenosis rate at follow-up (19.2% in stent vs. 16.4% in PTCA; p=NS) and TVR (17.5% in stent vs. 13.5% in PTCA; p=NS) were similar. Furthermore, event-free survival was 80.8% in the stent versus 83.1% in the PTCA group (p=NS). Overall costs (hospital and follow-up) were US $591,740 in the stent versus US $398,480 in the PTCA group (p < 0.02). CONCLUSIONS: The strategy of PTCA with delay angiogram and provisional stent if early loss occurs had similar restenosis rate and TVR, but lower cost than primary stenting after PTCA.

Learning curve of the Inoue technique of percutaneous mitral balloon valvuloplasty.

There is controversy as to whether the double-balloon or the Inoue technique of percutaneous mitral balloon valvuloplasty (PMBV) provides superior immediate and long-term results. This study was undertaken to analyze the effect of the learning curve of the Inoue technique of PMBV in the immediate and long-term outcome of PMBV. The learning curve of Inoue PMBV was analyzed in 233 Inoue PMBVs divided into 2 groups: "early experience" (n = 100) and "late experience" (n = 133). The results of the overall Inoue technique were compared with those of 659 PMBVs performed with the double-balloon technique. Baseline clinical and morphologic characteristics between early and late experience Inoue groups were similar. Post-PMBV mitral valve area (1.89 +/- 0.56 vs 1.69 +/- 0.57 cm(2); p = 0.008) and success rate (60% vs 75.9%; p = 0.009) were significantly higher in the late experience Inoue group. Furthermore, there was a trend for less incidence of severe post-PMBV mitral regurgitation > or = 3+ in the late experience group (6.8% vs 12%; p = 0.16). Although the post-PMBV mitral valve area was larger with the double-balloon technique (1.94 +/- 0.72 vs 1.81 +/- 0.58 cm(2); p = 0.01), the success rate (71.3% vs 69.1%; p = NS), incidence of > or = 3+ mitral regurgitation (9% vs 9%), in-hospital complications, and long-term and event-free survival were similar with both techniques. In conclusion, there is a significant learning curve of the Inoue technique of PMBV. Both the Inoue and the double-balloon techniques are equally effective techniques of PMBV because they resulted in similar immediate success, in-hospital adverse events, and long-term and event-free survival.

Effectiveness of and adverse events after percutaneous coronary intervention in patients with mild versus severe renal failure.

Patients with renal failure undergoing percutaneous coronary intervention (PCI) experience reduced procedural success rates and increased in-hospital and long-term follow-up major adverse cardiac events. This study was designed to determine whether the severity of preprocedural renal failure influences the outcomes of patients with renal failure undergoing PCI. We compared the immediate and long-term outcomes of 192 patients with mild renal failure (creatinine 1.6 to 2.0 mg/dl, mean 1.76) with those of 131 patients with severe renal failure (creatinine >2.0 mg/dl, mean 2.90), selected from 3,334 consecutive patients undergoing PCI between 1994 and 1997. Although the overall population with renal failure represents a high-risk group, the severe renal failure cohort had a higher incidence of hypertension, multivessel disease, prior coronary bypass surgery, vascular disease, and congestive heart failure (all p values <0.05), yet had similar angiographic characteristics. Procedural success was higher in the group with severe renal failure (93.7% vs 87.7%, p = 0.04). There were no statistically significant differences in in-hospital mortality (11.5% vs 9.9%, p = 0.7), Q-wave myocardial infarction (0.5% vs 0%, p = 0.4), emergent bypass surgery (0% vs 0%, p = 1.0), and in-hospital major adverse cardiac events (11.5% vs 9.9%, p = 0.7) between the mild and severe renal groups, respectively. Kaplan-Meier analyses showed no statistically significant difference in long-term survival (log rank test, p = 0.1) or event-free survival (log rank test, p = 0.3) between the 2 groups. Finally, creatinine was not identified as an independent predictor of in-hospital or long-term follow-up major adverse cardiac events. In our high-risk population, patients with mild renal insufficiency undergoing PCI experience major adverse outcomes in the hospital and at long-term follow-up similar to those of patients with severe renal failure.

Comparison of immediate and long-term results of mitral balloon valvotomy with the double-balloon versus Inoue techniques.

There is controversy as to whether the double-balloon or Inoue technique of percutaneous mitral balloon valvotomy (PMBV) provides superior immediate and long-term results. This study compares the immediate procedural and long-term outcomes of patients undergoing PMBV using the double-balloon versus the Inoue techniques. Seven hundred thirty-four consecutive patients who underwent PMBV using the double-balloon (n = 621) or Inoue technique (n = 113) were studied. There were no statistically significant differences in baseline clinical and morphologic characteristics between the double-balloon and Inoue patients. The double-balloon technique resulted in superior immediate outcome, as reflected in a larger post-PMBV mitral valve area (1.9 +/- 0.7 vs 1.7 +/- 0.6 cm2; p = 0.005) and a lower incidence of 3+ mitral regurgitation after PMBV (5.4% vs 10.6%; p = 0.05). This superior immediate outcome of the double-balloon technique was observed only in the group of patients with echocardiographic score < or = 8 (post-PMBV mitral valve areas 2.1 +/- 0.7 vs 1.8 +/- 0.6; p = 0.004). Despite the difference in immediate outcome, there were no significant differences in event-free survival at long-term follow-up between the 2 techniques. Our study demonstrates that compared with the Inoue technique, the double-balloon technique results in a larger mitral valve area and less degree of severe mitral regurgitation after PMBV. Despite the difference in immediate outcome between both techniques, there were no significant differences in event-free survival at long-term follow-up.

Continuous quality improvement decreases length of stay and adverse events: a case study in an interventional cardiology program.

A study was performed to assess the effectiveness of continuous quality improvement in achieving a better quality of care for patients undergoing coronary interventions. Increasing utilization of new coronary interventional devices has incurred a higher incidence of complications, prolonged hospital stay, and related costs. Using a clinical information system, we adopted continuous quality improvement to control the incidence of complications and postprocedural length of stay. Multiple regression analysis and a matched case-control study were performed to detect complications related to postprocedural length of stay and their causes among 342 patients. The results led to the modification of the postprocedural heparin anticoagulation protocol, which was followed by the introduction of a ticlopidine-based poststent anticoagulation regimen. Two sequential groups of patients (n = 261, n = 266) were selected to compare postprocedural length of stay and frequency of complications with those for the first group. Adjustments were made for patients and procedural characteristics through stratification and multiple regression methods. Blood transfusion was the most important predictor of prolonged hospital stay (partial R2 = 0.26, P < 0.01). A high level of postprocedural anticoagulation and intracoronary stent use were significantly associated with blood transfusion (P = 0.01, P = 0.02, respectively). The comparison among the three groups showed that heparin protocol change reduced only postprocedural length of stay (P < 0.001) for patients without stents, whereas the stent change in anticoagulation protocol significantly reduced both transfusion and hospital stay for patients with stents (P < 0.001, P < 0.05, respectively). Continuous quality improvement based on clinical information is promising to control both complications and hospital costs. Physician involvement is necessary throughout the process.