Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from CENTURY II trial.

OBJECTIVE: To demonstrate the safety and efficacy of a new sirolimus eluting stent with bioresorbable polymer, Ultimaster, (BP-SES) compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in bifurcation lesions with respect to the freedom from Target Lesion Failure at 1-year. METHODS: Within 1,119 patients enrolled in the CENTURY II randomized controlled multicenter trial, 194 patients were treated for bifurcation lesions and randomized to either BP-SES (n = 95) or PP-EES (n = 99). The primary endpoint was freedom from target lesion failure (TLF) composite endpoint [cardiac death, MI not clearly attributable to a non-target vessel, and clinically driven target lesion revascularization (TLR)] at 1-year. RESULTS: Baseline patient demographic, angiographic, and stenting characteristics were similar in both study arms. A single stent technique with provisional or "cross over" stenting were the most widely used in both arms (93.2% BP-SES vs. 92.4% PP-EES). Freedom from TLF at 1-year was 94.7% for BP-SES and 91.9% for PP-EES (P for noninferiority 0.031). The rate of clinically driven target lesion revascularization (TLR) at 1-year was 3.2% for BP-SES and 3.0% for PP-EES (P = 0.95). There were no significant differences detected in any of the individual clinical endpoints or other secondary clinical endpoints between the study arms at 1-year follow up. CONCLUSIONS: The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting in the treatment of patients with bifurcation lesions at 1-year follow up. © 2015 Wiley Periodicals, Inc.

Occupational eye lens doses in interventional cardiology. A multicentric study.

New European regulation regarding radiological protection of workers and more specifically the new occupational dose limit for the eye lens recently reduced to 20 mSv yr(-1) may affect interventional cardiologists. This paper presents a set of measurements of occupational doses performed in five interventional cardiology centres and then compared with the new dose limit. The measurement of occupational doses was performed over the apron at chest level using electronic dosemeters recording H p(10). In one of the centres, scatter dose at goggles was also measured with optically stimulated luminescence dosemeters calibrated in terms of H p(0.07). An average H p(10) over the apron of 46 µSv/procedure was measured for cardiologists. Lower doses were noted in other professionals like second cardiologists, nurses or anaesthetists. Procedures for valvular and other structural heart diseases involved the highest occupational doses, averaging over 100 µSv/procedure. Important differences in occupational doses among centres may be indicative of different radiation protection habits. The new occupational dose limit for the eye lens is likely to be exceeded by those among the interventionalists who do not use protection tools (ceiling suspended screen and/or goggles) even with standard workloads.

NETs detection and quantification in paraffin embedded samples using confocal microscopy.

Detection and quantification of Neutrophil Extracellular Traps (NETs) in tissue samples has become a topic of great interest to understand their pathological role in various diseases. We describe a semi-automatic method of visualization and quantification of NETs in paraffin-embedded intracoronary thrombus aspirate samples. This study is based on colocalization of myeloperoxidase (MPO) and citrullinated histone 3 (H3Cit) as hallmark of the presence of NETs. For the analysis we used the confocal immunofluorescence microscopy technology to quantify the number of fields and the total area (in µm2) containing NETs in each thrombus sample. This observer-independent quantification method could be a useful tool to standardize the study of NETs in paraffin-embedded tissues, enabling comparison of results among different laboratories.

Study of the evolution of the shear stress on the restenosis after coronary angioplasty.

In this article, we analyze the influence of fluid dynamics variables on the development of obstructive coronary artery disease in the medium term after percutaneous coronary intervention with stent implantation. We have analyzed a group of seven patients and the study is focused on the mid-right coronary artery. In these patients we have studied the relationship between wall shear stress and arterial wall thickness both immediately after stent implantation and six months later. The realistic three-dimensional (3D) reconstruction of the arteries is performed with the data obtained with intravascular ultrasound (IVUS) and angiography. The commercial code Fluent is used to solve the Navier-Stokes equations. Special attention is paid to the shear stress on the wall arteries and the corresponding thickness. The results show that there is a negative correlation for most of the cases between the wall shear stress and increase in wall thickness. A model is proposed to study the instability at the wall, and qualitative agreement is found.

Carvedilol for prevention of restenosis after directional coronary atherectomy : final results of the European carvedilol atherectomy restenosis (EUROCARE) trial.

BACKGROUND: In addition to its known properties as a competitive, nonselective beta and alpha-1 receptor blocker, carvedilol directly inhibits vascular myocyte migration and proliferation and exerts antioxidant effects that are considerably greater than those of vitamin E or probucol. This provides the basis for an evaluation of carvedilol for the prevention of coronary restenosis. METHODS AND RESULTS: In a prospective, double-blind, randomized, placebo-controlled trial, 25 mg of carvedilol was given twice daily, starting 24 hours before scheduled directional coronary atherectomy and continuing for 5 months after a successful procedure. The primary end point was the minimal luminal diameter as determined during follow-up angiography 26+/-2 weeks after the procedure. Of 406 randomized patients, 377 underwent attempted atherectomy, and in 324 (88.9%), a

Early angiographic changes of side branches arising from a Palmaz-Schatz stented coronary segment: results and clinical implications.

OBJECTIVES: The purpose of this study was to assess the effects and clinical implications of Palmaz-Schatz stent implantation on coronary blood flow in side branches arising from a stented coronary artery segment. BACKGROUND: The occlusion of a side branch is a well defined risk after balloon angioplasty. However, the impact of stenting on the coronary flow in side branches arising within the stented segment is unknown. METHODS: Forty-six stented coronary artery segments with 79 side branches emerging from the stented segment were analyzed. Angiographic studies were performed before angioplasty, after balloon dilation, immediately after stenting and 24 h later. Side branches were classified as follows: type A (> or = 1 mm in diameter, with ostial narrowing), type B (> or = 1 mm in diameter, without ostial narrowing), type C (< 1 mm in diameter, with ostial narrowing) and type D (< 1 mm in diameter, without ostial narrowing). Quantitative angiography was used to assess the diameter of the side branches. RESULTS: Stents were implanted electively in lesions with restenosis (41 stents, 89%) or with a suboptimal result after angioplasty (5 stents, 11%). Nine side branches (11%) were type A, 25 (32%) type B, 7 (9%) type C and 38 (48%) type D. At baseline, 68 side branches had Thrombolysis in Myocardial Infarction (TIMI) trial flow grade 3; 10 had grade 2; and 1 had grade 1. Flow worsened (TIMI grade > or = 1) in six side branches (8%) after balloon dilation and in four side branches (5%) after stenting. One additional side branch (1%) was occluded at 24 h. Of the 34 side branches > or = 1 mm in diameter (mean diameter 1.5 +/- 0.3 mm), 2 (6%) had flow impairment after stenting. Three patients experienced transient angina, but no acute myocardial infarction occurred as a result of a side branch occlusion. CONCLUSIONS: Coronary artery stenting does not modify anterograde flow in 90% of side branches. Coronary flow is reduced after stenting in a few branches, but this does not appear to have major clinical relevance.

Angioscopic findings during coronary angioplasty of coronary occlusions.

OBJECTIVES: This study sought to elucidate angioscopic findings in totally occluded vessels before and after intervention. BACKGROUND: Coronary angioscopy allows direct visualization of the lumen surface of the coronary arteries; however, the utility of coronary angioscopy during coronary angioplasty of vessels with a total occlusion is unknown. METHODS: Twenty-one consecutive patients (mean [+/- SD] 58 +/- 9 years, range 39 to 77; 3 women, 18 men) undergoing dilation of an occluded vessel were studied with coronary angioscopy. Occlusions were classified as functional in 8 patients (Thrombolysis in Myocardial Infarction [TIMI] flow grade 1) and anatomic in 13 (TIMI flow grade 0). Once the guide wire had crossed the occlusion, coronary angioscopy was attempted before and after angioplasty. RESULTS: In all patients, coronary angioscopy before dilation visualized protruding material occluding the coronary lumen where the guide wire was wedged. The occlusion consisted of red thrombus in 19 patients (90%) (2 with isolated occlusive thrombus, 17 with thrombus associated with atherosclerotic plaque) and protruding yellow plaque in 2 patients (10%). However, on angiography only 7 occlusions (33%) had data consistent with thrombus (p < 0.01 vs. coronary angioscopy). Successful dilation was obtained in 20 patients. After dilation, coronary angioscopy was repeated in 18 patients, revealing residual thrombus with plaque in 16 (89%) and a residual yellow plaque in 2. In addition, coronary angioscopy revealed coronary dissections in 13 patients (72%); however, angiography revealed dissections only in 10 patients (55%) and residual thrombus in 2 (10%) (p < 0.001). In one patient, coronary angioscopy visualized silent distal embolization of a red thrombus not previously recognized on angiography. CONCLUSIONS: Before intervention, coronary angioscopy provides unique insights into the pathologic substrate of occluded coronary vessels. An occlusive plaque with thrombus is the most common underlying substrate in these lesions. After successful dilation, angiographically silent mural thrombus is seen in most patients. This information could be used to assist in the selection of candidates and type of coronary interventions and could also prove to be of prognostic value in patients with occluded vessels.

Determinants of coronary compliance in patients with coronary artery disease: an intravascular ultrasound study.

OBJECTIVES: The aim of this study was to elucidate determinants of coronary compliance in patients with coronary artery disease. BACKGROUND: Intravascular ultrasound potentially enables in vivo evaluation of coronary artery compliance. METHODS: Twenty-seven patients (mean age [+/- SD] 57 +/- 11 years, three women) undergoing coronary angioplasty were studied with intravascular ultrasound imaging. A mechanical intravascular ultrasound system (4.8F, 20 MHz) was used. A total of 58 different coronary segments (proximal to the target angiographic lesion) were studied. Of these, 35 were located in the left anterior descending, 9 in the left main, 8 in the left circumflex and 6 in the right coronary arteries. During intravascular ultrasound imaging, 22 segments (38%) appeared normal, but 36 (62%) had plaque (24 fibrotic, 3 lipidic and 9 calcified). Systolic-diastolic changes in area (delta A) and pressure (delta P) with respect to vessel area (A) were used to study normalized compliance (Normalized compliance = [delta A/A]/delta P [mm Hg-1 x 10(3)]). RESULTS: Lumen area and plaque area were 12.6 +/- 5.7 and 3 +/- 3 min2, respectively. Plaque was concentric (more than two quadrants) at 10 sites, but the remaining 26 plaques were eccentric. Compliance was inversely related to age (r = -0.34, p < 0.05) but was not related to other clinical variables. Compliance was greater in the left main coronary artery (3.9 +/- 2.1 vs. 1.8 +/- 1.2 mm Hg-1, p < 0.05) and in coronary segments with normal findings on ultrasound imaging (2.9 +/- 1.9 vs. 1.6 +/- 1.1 mm Hg-1, p < 0.01). Moreover, at diseased coronary segments compliance was lower in calcified plaques than in other types of plaques (1.2 +/- 0.7 vs. 2.3 +/- 1.6 mm Hg-1, p < 0.01) but was similar in concentric and eccentric plaques (1.6 +/- 1.5 vs. 1.6 +/- 0.9 mm Hg-1). Plaque area (r = -0.38, p < 0.01) was inversely correlated with compliance. On multivariate analysis, only age and plaque area were independently related to compliance. CONCLUSIONS: Intravascular ultrasound may be used to evaluate compliance in patients with coronary artery disease. Compliance is reduced with increasing age and is mainly determined by the arterial site and by the presence, size and characteristics of plaque on intravascular ultrasound imaging.

Midterm outcome of patients with asymptomatic restenosis after coronary balloon angioplasty.

Although many patients with restenosis after balloon coronary angioplasty have recurrence of angina, others remain asymptomatic. To assess the clinical implications of asymptomatic coronary restenosis, we analyzed clinical and angiographic characteristics of 277 consecutive patients with restenosis, 133 (48%) of whom were asymptomatic (group I) and 144 (52%) symptomatic (group II). Restenosis was documented 6 to 9 months after the index procedure, or earlier if angina recurred, and was defined as a greater than 50% lumen narrowing (visual estimation). Group I (asymptomatic group) included fewer female (9% vs. 18%, p less than 0.05) and hypertensive patients (38% vs. 56%, p less than 0.005) and more patients with a previous myocardial infarction (48% vs. 28%, p less than 0.05) and single-vessel disease (67% vs. 55%, p less than 0.05). Before angioplasty, symptoms had lasted for a shorter period (10 +/- 25 vs. 23 +/- 42 months, p less than 0.001), ischemia after a recent infarction was a more frequent indication (21% vs. 10%, p less than 0.05) and total revascularization more frequently obtained (74% vs. 63%, p less than 0.05) in group I than in group II patients. Only a normal blood pressure, previous myocardial infarction, single-vessel disease and a shorter duration of symptoms were independent correlates of asymptomatic restenosis. No differences were found in stenosis severity before angioplasty (90% in both groups) or after angioplasty (22% +/- 12% vs. 24% +/- 16%).(ABSTRACT TRUNCATED AT 250 WORDS)

Coronary stenting for acute coronary dissection after coronary angioplasty: implications of residual dissection.

OBJECTIVES: The aim of this study was to assess the implications of residual coronary dissections after stenting. BACKGROUND: Coronary stenting is currently used in selected patients with coronary dissection after angioplasty. However, in some patients the total length of the dissection may not be completely covered with the device. METHODS: Forty-two consecutive patients (mean [+/- SD] age 58 +/- 11 years; 39 men, 3 women) undergoing stenting for a major coronary dissection after angioplasty were studied. RESULTS: Thirty (67%) coronary dissections were small (< or = 15 mm), and 29 (64%) were occlusive (Thrombolysis in Myocardial Infarction [TIMI] flow grade < or = 2). In 3 patients, coronary stenting was unable to open large occlusive dissections, but a good angiographic result was obtained in 39 patients (93%). After stenting, 22 of these patients (56%) had no visible residual dissections, and 13 (33%) had small and 4 (10%) had large residual dissections. These residual dissections were stable and did not compromise coronary flow. In a repeat angiogram (24 h later) the stent was patent in all 39 patients. However, two patients experienced a subacute stent occlusion. Of the remaining 37 patients, 36 (97%) had a late angiogram after stenting. Quantitative angiography revealed a reduction in minimal lumen diameter at the stent site (2.6 +/- 0.4 vs. 2 +/- 0.7 mm, p < 0.05) and a trend toward improvement in vessel diameter at the site of the previous residual dissection (1.7 +/- 0.6 vs. 1.9 +/- 0.5 mm, p < 0.1). The angiographic image of residual dissection disappeared in all patients. These factors provided a rather smooth angiographic appearance at follow-up. The four patients with large residual dissections after stenting did not have restenosis and were asymptomatic at last visit. CONCLUSIONS: Coronary stenting is effective in the management of acute coronary dissections after angioplasty. In this setting, small residual dissections are frequently seen but have a good outcome and disappear at follow-up. Large residual dissections may have a good outcome if coronary flow is not impaired and no residual stenosis is visualized.

Propensity and mechanisms of restenosis in different coronary stent designs: complementary value of the analysis of the luminal gain-loss relationship.

OBJECTIVES: This study sought to investigate the influence of stent design on the long-term angiographic outcome. BACKGROUND: The proportional relationship between vessel injury and late luminal loss in percutaneous revascularization should be best appreciated in coronary stenting, where recoil and shrinkage are theoretically minimal. It is unclear whether all stent designs can counterbalance this reactive loss by achieving a large initial luminal gain (bigger is better). METHODS: In 523 lesions successfully stented, the long-term angiographic results of slotted-tube (n = 331), coil (n = 85), multicellular (n = 70) and self-expandable mesh (n = 37) stent designs were compared using the angiographic gain-loss relationship (GLR). RESULTS: Restenosis rate was 10% for multicellular, 20% for slotted-tube, 46% for coil and 49% for self-expandable designs (p = 0.001). At a difference with other designs, no significant GLR was found in coil stents, suggesting additional mechanisms of luminal loss (i.e., plaque protrusion, stent compression) to neointimal proliferation. Significant differences in late loss between stents were found within each quartile of luminal gain, suggesting a specific role of design in luminal loss. Multivariate analysis identified use of coil and self-expandable stents, vessel size, minimal luminal diameter preintervention, luminal gain and stent length as variables with independent predictive value for several indices of angiographic long-term outcome. CONCLUSIONS: The analysis of GLR: 1) demonstrates that stent design influences late luminal loss; 2) challenges the applicability of the widely accepted "bigger is better" approach to all stent designs; and 3) appears as a valuable tool in assessing long-term stent performance.

Clinical and angiographic implications of coronary stenting in thrombus-containing lesions.

OBJECTIVES: This study sought to determine the results of coronary stenting in thrombus-laden lesions. BACKGROUND: The angiographic evidence of intracoronary thrombus has classically been considered a formal contraindication to stent implantation. However, with increasing use of stenting, the indications for this technique have widened to include treatment of patients who have an acute coronary syndrome or lesions with adverse anatomic features. METHODS: We studied 86 consecutive patients (mean age +/- SD 61 +/- 11 years, 14 women) undergoing coronary stenting of a thrombus-containing lesion; the procedure was performed electively in 39% and after angioplasty failure in 61%. Sixty-four patients (75%) were treated for unstable angina, and 19 (22%) underwent the procedure during an acute myocardial infarction. A specific protocol that included clinical and late angiographic follow-up was used. RESULTS: Angiographic success was obtained in 83 patients (96%). Five patients (6%) died during the hospital stay despite angiographic success; four of these had cardiogenic shock, and one (1%) had subacute stent thrombosis. Non-Q wave myocardial infarction developed in five additional patients (6%), and four of these five had data consistent with distal embolization. Of the 78 patients discharged with angiographic success, 67 (86%) were event-free and clinically improved at last follow-up visit (12 +/- 11 months). During the follow-up period, eight patients required repeat angioplasty, one patient required heart transplantation, and two patients died. Quantitative angiography demonstrated excellent angiographic results after stenting (minimal lumen diameter 0.31 +/- 0.4 vs. 2.77 +/- 0.6 mm). Late angiographic follow-up (5.5 +/- 1 months) was obtained in 50 patients with 54 lesions (93% of eligible), revealing a minimal lumen diameter of 2.0 +/- 1 mm and restenosis (lumen narrowing > 50%) in 18 lesions (33%). CONCLUSIONS: Coronary stenting constitutes an effective therapeutic strategy for patients with thrombus-containing lesions, either after failure of initial angioplasty or electively as the primary procedure. Coronary stenting in this adverse anatomic setting results in a high degree of angiographic success, a low incidence of subacute thrombosis and an acceptable restenosis rate.

The TITAN-AMI multicenter registry evaluating the usage of Titan2 stent in patients with ST segment elevation myocardial infarction. Final result at 12-month follow-up.

AIM: Primary percutaneous coronary intervention with stent implantation is the recommended treatment for patients with ST elevation myocardial infarction (STEMI). Data from randomised trials showed good performance by a titanium-nitric-oxide coated stent in this context. The aim of this study was to confirm these data. METHODS: A multicentre registry was compiled in 23 hospitals in Spain in an all-comers population. We selected patients with STEMI from a global Titan AMI registry that included patients with acute coronary syndrome. Primary endpoint was the composite of cardiac death, non-fatal myocardial infarction, stent thrombosis and target lesion revascularisation, at 12-month follow-up. RESULTS: The study included 893 patients with STEMI. We included all possibilities for PCI: 86.6% primary, 5% facilitated after successful fibrinolysis and 8.4% rescue PCI after failed fibrinolysis. The primary endpoint was reached in 8.4% of the patients: cardiac death 2.7%, reinfarction 3.4%, target lesion revascularisation 3.5% and definite or probable stent thrombosis 2.8%. The majority of stent thromboses presented in the first 30 days after PCI. CONCLUSION: A bioactive stent (titanium-nitric-oxide coated stent) is a possible alternative for the treatment of patients with STEMI. One-year follow-up showed better results than those presented by a regular bare-metal stent or first-generation drug-eluting stent in terms of stent thrombosis.

Diagnosis of aortic intramural hematoma by intravascular ultrasound imaging.

Our findings indicate the value of IVUS in the study of aortic intramural hematomas in ruling out other aortic diseases such as classic aortic dissection. This technique appears especially attractive for patients with suspected aortic dissection and a normal aortography.

Comparison of results of percutaneous transluminal coronary angioplasty with and without selective requirement of surgical standby.

To determine the outcome of percutaneous transluminal coronary angioplasty (PTCA) with the use of 2 different strategies of surgical coverage, the results of 1,283 consecutive PTCAs were analyzed. In 269 procedures (21%) (patients considered at high risk should acute vessel closure occur--standby group) the operating room and the surgical team were ready for an immediate intervention. In the remaining 1,014 procedures (79%) (backup group), although the surgical team was "in house," they were not necessarily ready for an immediate intervention. Mean age of the population was 58 +/- 10 years and 84% of patients were men. Coronary risk factors, medical treatment, clinical indication for PTCA, previous coronary surgery and left ventricular ejection fraction were similar in both groups. Dilatation was more frequently multiple (23 vs 16%, p less than 0.05), or performed in the left anterior descending coronary artery (71 vs 46%, p less than 0.001), in bypass grafts (4 vs 2%, p less than 0.02), in proximal coronary segments (72 vs 57%, p less than 0.001) or in lesions at bifurcation (35 vs 28%, p less than 0.02) in the standby than in the backup group, respectively. PTCAs were less frequently performed during the same diagnostic procedure (15 vs 34%, p less than 0.001) in the standby group. Angiographic success was obtained in 91 and 92% of the attempted lesions and PTCA success in 89 and 88% of the procedures in the standby and backup groups, respectively. The incidence of death (1 vs 0.7%), acute myocardial infarction (2.9 vs 2.7%) and emergency surgery (0.7 vs 0.1%) was also similar in both groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Angioscopic characteristics of coronary narrowing in patients with recurrent myocardial ischemia after myocardial infarction.

Coronary angioscopy was used to elucidate the underlying substrate of the culprit lesion in 20 patients with postinfarction ischemia and in 19 patients with other types of unstable angina. Plaque characteristics were similar in both groups, but red thrombi and occlusive thrombi were more frequently seen in patients with postinfarction ischemia.

Early and late results of percutaneous mitral valvuloplasty for mitral stenosis associated with mild mitral regurgitation.

To assess the influence of mild mitral regurgitation (MR) on the initial and long-term results of percutaneous mitral valvuloplasty (PMV), the baseline characteristics, early results and follow-up of 102 consecutive patients with mild MR before PMV (group I) were prospectively analyzed and compared with those of 186 consecutive patients without MR (group II). Age, gender and symptomatic status were similar in both groups, but more patients in group I were in atrial fibrillation (70 vs 54%, p < 0.05) and had had a previous episode of pulmonary edema (25 vs 14%, p < 0.05). On echocardiography, patients in group I had larger left atria (58 +/- 12 vs 53 +/- 10 mm, p < 0.05) and more calcified mitral valves (score 1.9 +/- 0.8 vs 1.5 +/- 0.7, p < 0.05), but the total echocardiographic score (8.0 +/- 2 vs 7.3 +/- 2) was similar in both groups. Baseline hemodynamic data were also similar in both groups. On multivariate analysis, group I patients were only independently associated with more calcified mitral valves and larger left atria. PMV success (area gain > or = 50% without complications) was similar (88 vs 86%) in both groups, but mitral valve area gain was smaller (0.8 +/- 0.3 vs 1.0 +/- 0.3 cm2, p < 0.05) in group I. After PMV an increase in the severity of MR > or = 2 grades (17 vs 6%, p < 0.05) occurred more frequently in group II patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Percutaneous mitral valvuloplasty with severe pulmonary artery hypertension.

The aim of this study was to assess the initial and midterm outcome of patients with severe pulmonary hypertension undergoing percutaneous mitral valvuloplasty (PMV). Accordingly, the baseline characteristics, immediate results and follow-up of 64 consecutive patients with severe pulmonary artery hypertension (systolic pulmonary artery pressure > or = 60 mm Hg on cardiac catheterization) (group I) were analyzed and compared with those of 194 consecutive patients with lower pulmonary pressures (group II). Patients in group I were more symptomatic (New York Heart Association functional class > or = III, 72 vs 40%, p < 0.001) and had higher echocardiographic scores (8.6 +/- 2 vs 7.4 +/- 1, p < 0.05). Before PMV, mitral gradient was higher (17 +/- 6 vs 13 +/- 5 mm Hg, p < 0.025) and mitral valve area smaller (0.79 +/- 0.2 vs 0.96 +/- 0.2 cm2, p < 0.005) in group I patients, who also had higher pulmonary vascular resistances (469 +/- 299 vs 157 +/- 125 dynes s-1 cm-5, p < 0.005). On multivariate analysis patients in group I were more symptomatic, had smaller mitral valve areas and higher mitral gradients. PMV success (area gain > 50% without complications) was similar (89 vs 87%) in both groups. After PMV final mitral gradient (5 +/- 2 vs 4 +/- 2 mm Hg) and area (1.82 +/- 0.5 vs 1.87 +/- 0.5 cm2) were similar in both groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Predictors, mechanisms and outcome of severe mitral regurgitation complicating percutaneous mitral valvotomy with the Inoue balloon.

During 241 consecutive percutaneous mitral valvotomy (PMV) procedures performed with the Inoue balloon, 16 patients (6.6%) developed severe mitral regurgitation (MR). Baseline clinical, echocardiographic (Doppler mitral valve area and Wilkins' score) and hemodynamic data were not different from those of patients without this complication. Severe MR occurred during the first inflation in 7 patients and after several stepwise inflations in 9. Although maximal balloon size was similar in both groups, unusual indentations and subvalvular inflations were more frequently observed in patients who developed severe MR. Early mitral valve replacement was required in 6 patients. All of them had a leaflet rupture either along the midportion (2 patients), along a commissure (4 patients), or both. Commissural calcium was present in 5 valves and 5 also had severe subvalvular involvement that had been underestimated by echocardiography. Of the 10 nonsurgically treated patients, 4 had chordal rupture by echocardiographic criteria, whereas in the remaining 6 the precise mechanism of MR could not be determined. During follow-up (11.4 +/- 4 months, range 1 to 30), 1 patient required surgery for symptoms and the remaining 9 were symptomatically improved and free of left ventricular dilatation. In conclusion, severe MR complicated 6.6% of PMV procedures with the Inoue balloon, and its mechanism was leaflet or chordal rupture. Although one third of the patients required early mitral surgery, most of the remaining obtained midterm symptomatic benefit.

Comparison of results of percutaneous mitral valvuloplasty in patients with large (greater than 6 cm) versus those with smaller left atria.

To determine whether the presence of an aneurysmatic (severely enlarged) left atrium (greater than 60 mm on echocardiography) influences results of percutaneous mitral valvuloplasty (PMV), the clinical, echocardiographic and hemodynamic characteristics and the results of this technique were compared in 46 consecutive patients with aneurysmatic left atrium (group I) and 125 consecutive patients without such echocardiographic finding (group II). Left atrial size was 70.5 +/- 8 vs 50.1 +/- 6 mm (p less than 0.005) in groups I and II, respectively. Patients in group I were older (57 +/- 12 vs 48 +/- 12 years, p less than 0.025), more symptomatic (New York Heart Association functional class greater than or equal to III or IV: 67 vs 42%, p less than 0.05), and had atrial fibrillation more frequently (91 vs 44%, p less than 0.001). The echocardiographic score (8.9 +/- 1.9 vs 7.5 +/- 2, p less than 0.005) and the incidence of mild mitral regurgitation on angiography before PMV (54 vs 30%, p less than 0.01) was also higher in group I patients. Hemodynamic parameters before PMV were similar in both groups, but after the procedure, final mitral valve area (1.61 +/- 0.5 vs 1.95 +/- 0.4 cm2, p less than 0.05) and the absolute increase in mitral area (0.81 +/- 0.3 vs 1.02 +/- 0.3 cm2, p less than 0.05) were lower and mean pulmonary artery pressure (35 +/- 10 vs 28 +/- 9 mm Hg, p less than 0.025) was higher in group I.(ABSTRACT TRUNCATED AT 250 WORDS)