Myocardial deformation assessment in patients with precapillary pulmonary hypertension: A cardiac magnetic resonance study.

PURPOSE: The purpose of this study was to investigate right atrial and ventricular strain parameters on cardiac magnetic resonance (CMR) in patients with precapillary pulmonary hypertension (PPH) and whether they can aid in the assessment of PPH prognosis. MATERIALS AND METHODS: Adult patients with groups 1 and 4 PPH were invited to participate in the study. Age- and sex-matched healthy volunteers were also recruited as controls. At baseline, patients underwent clinical examination, N-terminal pro-B-type natriuretic peptide measurement and CMR with feature tracking post-processing (CMR-FT). Healthy controls underwent only CMR-FT. The study's primary endpoint was clinical failure, defined as death, hospitalization or demonstrable clinical deterioration during follow-up. Patients who were unable to perform 6-minute walking test due to musculoskeletal disorders were excluded from the study. RESULTS: Thirty-six patients (8 men, 28 women; mean age, 50.6±13.8 [SD] years [range: 18.6-78.5years]) and 12 healthy control subjects (5 mean, 7 women; mean age, 40.6±13.5 [SD] years [range: 23.1-64.4years]) were recruited. Right ventricular global longitudinal strain (GLS) was significantly impaired in PPH patients (-20.2±5.3 [SD] % [range: -28.8 to -9.1%] vs. -28.4±3.1% [-33.7 to -22.7%] respectively, P<0.001). The right atrial GLS was significantly impaired in PPH compared to healthy controls (-19.9±4.5% [range: -28.6 to -3.6%] vs. -26.5±4.2% [range: -32.8 to -15.8%] respectively) (P<0.001). Clinical failure occurred in 19 (19/36, 53%) of patients. Right ventricular GLS predicted clinical failure most reliably among CMR parameters (-22.6±3.8 [SD] % [range: -27.6 to -12.7%] for patients without clinical failure vs. -18±5.6 [SD] % [range: -28.8 to -9.1%] for patients with clinical failure; hazard ratio [HR]=1.85; P=0.007; area under the AUC curve=0.75). Lower absolute right atrial GLS was significantly associated with clinical failure (-22.7±3.0 [SD] % [range: -28.6 to -17.7%] for patients without clinical failure vs. -16.9±5.8 [SD] % [range: -24.2 to -3.6%] for patients with clinical failure) (HR=1.53; P=0.035). CONCLUSION: CMR feature tracking-derived myocardial strain parameters of both the right atrium and ventricle can assist clinicians in the prognosis of PPH.

Aortic balloon valvuloplasty before transcatheter valve replacement in high-risk patients with aortic stenosis. Cardiac catheterization and echocardiographic hemodynamic study.

BACKGROUND: Balloon aortic valvuloplasty (BAV) has been revived as a bridge to transcatheter aortic valve replacement (TAVR). The aim of the current prospective study was to define a safe time period from BAV to TAVR and to determine hemodynamic variables that predict event-free survival after BAV. PATIENTS AND METHODS: The present prospective study included 68 consecutive patients with severe aortic stenosis who were treated initially with BAV from 2009 to 2012. Echocardiographic and invasive hemodynamic assessments were performed before BAV. The patients were followed up at regular intervals and events were defined as cardiac hospitalization or death. RESULTS: Invasive hemodynamic evaluation yielded more favorable results than echocardiographic assessment: aortic stenosis was less severe, cardiac output was higher, and pulmonary capillary wedge pressure (PCWP) was lower. Post-BAV event-free survival was 80.4 % at 30 days, 64.5 % at 6 months, 37 % at 1 year, 22.3 % at 2 years, and 9.3 % at 3 years. After excluding pre-discharge deaths (n = 7), the 30-day event-free survival rate was 90 %. Predictors of events after BAV were atrial fibrillation, cardiogenic shock, elevated euroSCORE (European System for Cardiac Operative Risk Evaluation), elevated PCWP, and elevated pulmonary artery systolic pressure. Invasively measured PCWP was the only independent predictor of events (hazard ratio, 1.07; 95 % confidence interval, 1.03-1.11; p = 0.001). CONCLUSION: A 30-day post-BAV period may be considered a bridge to TAVR. Furthermore, invasive assessment of PCWP before BAV is an independent hemodynamic predictor of events after BAV.

Long term outcome after intracoronary beta radiation therapy.

OBJECTIVES: To determine the long term outcome after intracoronary beta radiation therapy (IRT). SETTING: Tertiary referral centre. METHODS: The rate of major adverse cardiac events (MACE) was retrospectively determined in 301 consecutive patients who were treated with IRT. MACE was defined as death, myocardial infarction, or any reintervention. Long term clinical outcome was obtained from an electronic database of hospital records and from questionnaires to the patients and referring physicians. Long term survival status was assessed by written inquiries to the municipal civil registries. RESULTS: The mean (SD) follow up was 3.6 (1.2) years. The cumulative incidence of MACE at six months was 19.1%, at one year 36.4%, and at four years 58.3%. The target lesion revascularisation (TLR) rate at six months was 12.9%, at one year 28.3%, and at four years 50.4%. From multivariate analysis, dose < 18 Gy was the most significant predictor of TLR. At four years the cumulative incidence of death was 3.8%, of myocardial infarction 13.4%, and of coronary artery bypass surgery 11.3%. Total vessel occlusion was documented in 12.3% of the patients. CONCLUSIONS: In the long term follow up of patients after IRT, there are increased adverse cardiac events beyond the first six months.

One year clinical follow up of paclitaxel eluting stents for acute myocardial infarction compared with sirolimus eluting stents.

OBJECTIVE: To compare clinical outcome of paclitaxel eluting stents (PES) versus sirolimus eluting stents (SES) for the treatment of acute ST elevation myocardial infarction. DESIGN AND PATIENTS: The first 136 consecutive patients treated exclusively with PES in the setting of primary percutaneous coronary intervention for acute myocardial infarction in this single centre registry were prospectively clinically assessed at 30 days and one year. They were compared with 186 consecutive patients treated exclusively with SES in the preceding period. SETTING: Academic tertiary referral centre. RESULTS: At 30 days, the rate of all cause mortality and reinfarction was similar between groups (6.5% v 6.6% for SES and PES, respectively, p = 1.0). A significant difference in target vessel revascularisation (TVR) was seen in favour of SES (1.1% v 5.1% for PES, p = 0.04). This was driven by stent thrombosis (n = 4), especially in the bifurcation stenting (n = 2). At one year, no significant differences were seen between groups, with no late thrombosis and 1.5% in-stent restenosis (needing TVR) in PES versus no reinterventions in SES (p = 0.2). One year survival free of major adverse cardiac events (MACE) was 90.2% for SES and 85% for PES (p = 0.16). CONCLUSIONS: No significant differences were seen in MACE-free survival at one year between SES and PES for the treatment of acute myocardial infarction with very low rates of reintervention for restenosis. Bifurcation stenting in acute myocardial infarction should, if possible, be avoided because of the increased risk of stent thrombosis.

Routine sirolimus eluting stent implantation for unselected in-stent restenosis: insights from the rapamycin eluting stent evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry.

OBJECTIVE: To assess the effectiveness of routine sirolimus eluting stent (SES) implantation for unselected patients with in-stent restenosis and to provide preliminary information about the angiographic outcome for lesion subgroups and for different in-stent restenosis patterns. DESIGN: Prospective, single centre registry. SETTING: Tertiary referral centre. PATIENTS: 44 consecutive patients (53 lesions) without previous brachytherapy who were treated with SES for in-stent restenosis were evaluated. Routine angiographic follow up was obtained at six months and the incidence of major adverse cardiovascular events was evaluated. RESULTS: At baseline, 42% of the lesions were focal, 21% diffuse, 26% proliferative, and 11% total occlusions. Small vessel size (reference diameter < or = 2.5 mm) was present in 49%, long lesions (> 20 mm) in 30%, treatment of bypass grafts in 13%, and bifurcation stenting in 18%. At follow up, post-SES restenosis was observed in 14.6%. No restenosis was observed in focal lesions. For more complex lesions, restenosis rates ranged from 20-25%. At the one year follow up, the incidence of death was 0, myocardial infarction 4.7% (n = 2), and target lesion revascularisation 16.3% (n = 7). The target lesion was revascularised because of restenosis in 11.6% (n = 5). CONCLUSIONS: Routine SES implantation is highly effective for focal in-stent restenosis and appears to be a promising strategy for more complex patterns of restenosis.

Sonotherapy, antirestenotic therapeutic ultrasound in coronary arteries: the first clinical experience.

We studied the safety and feasibility of intracoronary sonotherapy (IST) and its effect on the coronary vessel at 6 months. Thirty-seven patients with stable or unstable angina were included (40 lesions). The indication was de novo lesion (n = 26), restenosis (n = 2), in-stent restenosis (n = 11), and a total occlusion of a venous bypass graft. After successful angioplasty, IST was performed using a 5 Fr catheter with three serial ultrasound transducers operating at 1 MHz. IST was successfully performed in 36 lesions (success rate, 90%). IST exposure time per lesion was 718 +/- 127 sec. During hospital stay, one patient died due to a bleeding complication. At 6-month follow-up, one patient experienced acute myocardial infarction, eight patients underwent repeat PTCA. No patient underwent CABG. Late lumen loss was 1.05 +/- 0.70 mm with a restenosis rate of 25%. IVUS analysis revealed a neointima burden of 25% +/- 11%. IST can be applied safely and with high acute procedural success. Sonotherapy-related major adverse events were not observed. Late lumen loss and neointimal growth were similar to conventional PTCA approaches. These results justify the initiation of randomized clinical efficacy studies.

Intracoronary beta-radiation to reduce restenosis after balloon angioplasty and stenting; the Beta Radiation In Europe (BRIE) study.

AIMS: The BRIE trial is a registry evaluating the safety and performance of (90)Sr delivered locally (Beta-Cath TM system of Novoste) to de-novo and restenotic lesions in patients with up to two discrete lesions in different vessels. METHODS AND RESULTS: In total, 149 patients (175 lesions) were enrolled; 62 treated with balloons and 113 with stents. The restenosis rate, the minimal luminal diameter and the late loss were determined in three regions of interest: (a) in a subsegment of 5mm containing the original minimal luminal diameter pre-intervention termed target segment; (b) the irradiated segment, 28 mm in length, and (c) the entire analysed segment, 42 mm in length, termed the vessel segment. Binary restenosis was 9.9% for the target segment, 28.9% for the irradiated segment, and 33.6% for the vessel segment. These angiographic results include 5.3% total occlusions. Excluding total occlusions binary restenosis was 4.9%, 25% and 29.9%, respectively. At 1 year the incidence of major adverse cardiac events placed in a hierarchical ranking were: death 2%, myocardial infarction 10.1%, CABG 2%, and target vessel revascularization 20.1%. The event-free survival rate was 65.8%. Non-appropriate coverage of the injured segment by the radioactive source termed geographical miss affected 67.9% of the vessels, and increased edge restenosis significantly (16.3% vs 4.3%, P=0.004). It accounted for 40% of the treatment failures. CONCLUSION: The results of this registry reflect the learning process of the practitioner. The full therapeutic potential of this new technology is reflected by the restenosis rate at the site of the target segment. It can only be unravelled once the incidence of late vessel occlusion and geographical miss has been eliminated by the prolonged use of thienopyridine, the appropriate training of the operator applying this new treatment for restenosis prevention, and the use of longer sources.

Routine intracoronary beta-irradiation. Acute and one year outcome in patients at high risk for recurrence of stenosis.

AIMS: Intracoronary radiation is a promising therapy potentially reducing restenosis following catheter-based interventions. Currently, only limited data on this treatment are available. The feasibility and outcome in daily routine practice, however, is unknown. METHODS AND RESULTS: In 100 consecutive patients, intracoronary beta-radiation was performed with a (90)Strontium system (Novoste Beta-Cathtrade mark) following angioplasty. Predominantly complex (73% type B2 and C) and long lesions (length 24.3+/-15.3 mm) were included (37% de novo, 19% restenotic and 44% in-stent restenotic lesions). Radiation success was 100%. Mean prescribed dose was 19.8+/-2.5 Gy. A pullback procedure was performed in 19% lesions. Geographic miss occurred in 8% lesions. Periprocedural thrombus formation occurred in four lesions, dissection in nine lesions. During hospital stay, no death, acute myocardial infarction, or repeat revascularization was observed. Major adverse cardiac events occurred predominantly between 6 and 12 months after the index procedure with major adverse cardiac event-free survival of 66% at 12 months (one death, 10 Q-wave myocardial infarctions, 23 target vessel revascularizations; ranked for worst event). CONCLUSION: Routine catheter-based intracoronary beta-radiation therapy after angioplasty is safe and feasible with a high acute procedural success. The clinical 1-year follow-up showed delayed occurrence of major adverse cardiac events between 6 and 12 months after the index procedure.

In vitro study of FFR, QCA, and IVUS for the assessment of optimal stent deployment.

We tested whether fractional flow reserve (FFR) discriminates between suboptimally and optimally deployed stents. Latex tubes (diameter solidus in circle = 4 mm) with diameter stenosis 40% (n = 3), 50% (n = 3) and 60% (n = 3) were tested in a pulsatile flow system, using water. Measurements were done at baseline (n = 9; FFR/QCA) and after suboptimal (SOD; 3-mm balloon at 8 atm) and optimal (OD; 4 mm balloon at 16 atm) deployment of a 35-mm stent (n = 6; FFR/QCA/IVUS). Varying Q from 150 to 50 ml/min increased FFR by 2-7%. Conversely, at 100 ml/min, FFR increased by only 0.8% from SOD to OD (P < 0.05). Extrapolating data to blood flow, the gain in FFR from SOD to OD is less than 5% for Q = 100 ml/min, while FFR may increase by 15-20% by changes in blood flow from 50 to 150 ml/min. We conclude that IVUS and QCA are more appropriate for the assessment of optimal stent deployment.

Evaluation of left ventricular function and volumes in patients with ischaemic cardiomyopathy: gated single-photon emission computed tomography versus two-dimensional echocardiography.

UNLABELLED: The objective of this study was to perform a head-to-head comparison between two-dimensional (2D) echocardiography and gated single-photon emission computed tomography (SPET) for the evaluation of left ventricular (LV) function and volumes in patients with severe ischaemic LV dysfunction. Thirty-two patients with chronic ischaemic LV dysfunction [mean LV ejection fraction (EF) 25%+/-6%] were studied with gated SPET and 2D echocardiography. Regional wall motion was evaluated by both modalities and scored by two independent observers using a 16-segment model with a 5-point scoring system (1= normokinesia, 2= mild hypokinesia, 3= severe hypokinesia, 4= akinesia and 5= dyskinesia). LVEF and LV end-diastolic and end-systolic volumes were evaluated by 2D echocardiography using the Simpson's biplane discs method. The same parameters were calculated using quantitative gated SPET software (QGS, Cedars-Sinai Medical Center). The overall agreement between the two imaging modalities for assessment of regional wall motion was 69%. The correlations between gated SPET and 2D echocardiography for the assessment of end-diastolic and end-systolic volumes were excellent (r=0.94, P<0.01, and r=0.96, P<0.01, respectively). The correlation for LVEF was also good (r=0.83, P<0.01). IN CONCLUSION: in patients with ischaemic cardiomyopathy, close and significant relations between gated SPET and 2D echocardiography were observed for the assessment of regional and global LV function and LV volumes; gated SPET has the advantage that it provides information on both LV function/dimensions and perfusion.

Geographical miss during catheter-based intracoronary beta-radiation: incidence and implications in the BRIE study. Beta-Radiation In Europe.

OBJECTIVES: We sought to determine the incidence and causes of geographical miss (GM) and to evaluate its impact on edge restenosis after intracoronary beta-radiation therapy. BACKGROUND: Edge restenosis is a limitation of intracoronary beta-radiation therapy. Geographical miss is the situation in which the radiation source does not fully cover the injured segment and may lead to edge restenosis. METHODS: We analyzed 175 vessels treated according to the Beta-Radiation In Europe (BRIE) study protocol. The effective irradiated segment (EIRS) and both edges were studied with quantitative coronary angiography. The edges of the EIRS that were injured constituted the GM edges. Restenosis was defined as diameter stenosis >50% at follow-up. Geographical miss was determined by simultaneous electrocardiographic-matched, side-by-side projection of the source and balloons deflated at the injury site, in identical angiographic projections surrounded by contrast. RESULTS: Geographical miss affected 41.2% of the edges and increased edge restenosis significantly compared with non-GM edges (16.3% vs. 4.3%, respectively, p = 0.004). Restenosis was increased both in the proximal (p = 0.05) and distal (p = 0.02) GM edges compared with noninjured edges. Geographical miss associated with stent injury significantly increased edge restenosis (p = 0.006), whereas GM related to balloon injury did not significantly increase edge restenosis (p = 0.35). The restenosis in the EIRS was similar between vessels with and without GM (24.3% and 21.6%, respectively, p = 0.8). CONCLUSIONS: Geographical miss is strongly associated with restenosis at the edges of the EIRS. This effect is more prominent when caused by stenting. Geographical miss does not increase restenosis in the EIRS.

Uncomplicated moderate coronary artery dissections after balloon angioplasty: good outcome without stenting

Objective—To study the relation between moderate coronary dissections, coronary flow velocity reserve (CFVR), and long term outcome. Methods—523 patients undergoing balloon angioplasty and sequential intracoronary Doppler measurements were examined as part of the DEBATE II trial (Doppler endpoints balloon angioplasty trial Europe). After successful balloon angioplasty, patients were randomised to stenting or no further treatment. Dissections were graded at the core laboratory by two observers and divided into four categories: none, mild (type A-B), moderate (type C), severe (types D to F). Patients with severe dissections (n = 128) or without available reference vessel CFVR (n = 139) were excluded. The remaining 256 patients were divided into two groups according to the presence (group A, n = 45) or absence (group B, n = 211) of moderate dissection. Results—Following balloon angioplasty, there was no difference in CFVR between the two groups. At 12 months follow up, a higher rate of major adverse cardiac events was observed overall in group A than in group B (10 (22%) v 23 (11%), p = 0.041). However, the risk of major adverse events was similar in the subgroups receiving balloon angioplasty (group A, 6 (19%) v group B, 16 (16%), NS). Among group A patients, the adverse events risk was greater in those randomised to stenting (odds ratios 6.603 v 1.197, p = 0.046), whereas there was no difference in risk if the group was analysed according to whether the CFVR was 2.5 after balloon angioplasty. Conclusions—Moderate dissections left untreated result in no increased risk of major adverse cardiac events. Additional stenting does not improve the long term outcome.

Uncomplicated moderate coronary artery dissections after balloon angioplasty: good outcome without stenting.

OBJECTIVE: To study the relation between moderate coronary dissections, coronary flow velocity reserve (CFVR), and long term outcome. METHODS: 523 patients undergoing balloon angioplasty and sequential intracoronary Doppler measurements were examined as part of the DEBATE II trial (Doppler endpoints balloon angioplasty trial Europe). After successful balloon angioplasty, patients were randomised to stenting or no further treatment. Dissections were graded at the core laboratory by two observers and divided into four categories: none, mild (type A-B), moderate (type C), severe (types D to F). Patients with severe dissections (n = 128) or without available reference vessel CFVR (n = 139) were excluded. The remaining 256 patients were divided into two groups according to the presence (group A, n = 45) or absence (group B, n = 211) of moderate dissection. RESULTS: Following balloon angioplasty, there was no difference in CFVR between the two groups. At 12 months follow up, a higher rate of major adverse cardiac events was observed overall in group A than in group B (10 (22%) v 23 (11%), p = 0.041). However, the risk of major adverse events was similar in the subgroups receiving balloon angioplasty (group A, 6 (19%) v group B, 16 (16%), NS). Among group A patients, the adverse events risk was greater in those randomised to stenting (odds ratios 6.603 v 1.197, p = 0.046), whereas there was no difference in risk if the group was analysed according to whether the CFVR was < 2.5 or >/= 2.5 after balloon angioplasty. CONCLUSIONS: Moderate dissections left untreated result in no increased risk of major adverse cardiac events. Additional stenting does not improve the long term outcome.

The pattern of restenosis and vascular remodelling after cold-end radioactive stent implantation.

BACKGROUND: Edge restenosis is a major problem after radioactive stenting. The cold-end stent has a radioactive mid-segment (15.9 mm) and non-radioactive proximal and distal 5.7 mm segments. Conceptually this may negate the impact of negative vascular remodelling at the edge of the radiation. METHOD AND RESULTS: ECG-gated intravascular ultrasound with three-dimensional reconstruction was performed post-stent implantation and at the 6-month follow-up to assess restenosis within the margins of the stent and at the stent edges in 16 patients. Angiographic restenosis was witnessed in four patients, all in the proximal in-stent position. By intravascular ultrasound in-stent neointimal hyperplasia, with a >50% stented cross-sectional area, was seen in eight patients. This was witnessed proximally (n=2), distally (n=2) and in both segments (n=4). Echolucent tissue, dubbed the 'black hole' was seen as a significant component of neointimal hyperplasia in six out of the eight cases of restenosis. Neointimal hyperplasia was inhibited in the area of radiation: Delta neointimal hyperplasia=3.72 mm3 (8.6%); in-stent at the edges of radiation proximally and distally Delta neointimal hyperplasia was 7.9 mm3 (19.0%) and 11.4 mm3 (25.6%), respectively (P=0.017). At the stent edges there was no significant change in lumen volume. CONCLUSIONS: Cold-end stenting results in increased neointimal hyperplasia in in-stent non-radioactive segments.