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With a growing geriatric population estimated to triple by 2050, minimally invasive procedures that are image-guided are becoming both more popular and necessary for treating a variety of diseases. To lower the learning curve for new procedures, it is necessary to develop better guidance systems and methods to analyze procedure performance. Since fluoroscopy remains the primary mode of visualizations, the ability to perform catheter tracking from fluoroscopic images is an important part of this endeavor. This paper explores the use of deep learning to perform the landmark detection of a catheter from fluoroscopic images in 3D-printed heart models. We show that a two-stage deep-convolutional-neural-network-based model architecture can provide improved performance by initially locating a region of interest before determining the coordinates of the catheter tip within the image. This model has an average error of less than 2% of the image resolution and can be performed within 4 milliseconds, allowing for its potential use for real-time intraprocedural tracking. Coordinate regression models have the advantage of directly outputting values that can be used for quantitative tracking in future applications and are easier to create ground truth values (~50× faster), as compared to semantic segmentation models that require entire masks to be made. Therefore, we believe this work has better long-term potential to be used for a broader class of cardiac devices, catheters, and guidewires.

PURPOSE: We sought to determine the performance of an automated computed tomography (CT) software that provides dynamic annular measurements of all available cardiac phases for transcatheter aortic valve replacement (TAVR) sizing as compared to the standard single manual measurement. MATERIALS AND METHODS: In 60 TAVR patients (84±7 years, 60% male) who underwent pre-procedural CT scans, we measured the aortic annular diameters, perimeter, and area using (1) the dynamic automated CT measurements and (2) standard single manual measurement from the cardiac phase of maximum systolic opening by visual estimate. RESULTS: The automated software was successful in providing annular measurements in 43/60 (72%) of cases, with the remainder requiring semi-automated contours. The maximum dynamic automated values were predominantly in systole (46/60[77%] for diameter, 44/60[73%] for perimeter, 48/60[80%] for area), and was a different phase from the standard manual phase in 46/60 (77%) cases. The maximum dynamic automated annular values were larger than the standard manual values measured (Δdiameter 0.35 mm, p=0.04; Δperimeter 1.71 mm, p

Aims We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. Methods and results From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P

Objectives Left atrial appendage thrombus (LAT) was an exclusion criterion in the seminal transcatheter aortic valve replacement (TAVR) trials; however, such patients do undergo TAVR in the 'real-world' setting. This study sought to analyse outcomes after TAVR in patients with LAT or spontaneous echo contrast (SEC). Methods All patients undergoing TAVR at our institution between March 2009 and December 2014 were prospectively analysed. The presence of LAT or SEC was determined via a retrospective chart review. Primary outcomes included 30-day and 1-year neurological events as well as mortality. Results Of the 369 patients undergoing TAVR, 3.8% (14) were found to have LAT and 6.8% (25) were found to have SEC, and they were separately compared to patients who did not have LAT or SEC. Significant differences were noted between groups with regard to preoperative renal function, atrial fibrillation and ejection fraction. Preoperative atrial fibrillation was the only independent predictor of LAT. No perioperative complications were associated with the presence of LAT or SEC. Specifically, no patient with LAT or SEC experienced a postoperative neurological event. While neither LAT nor SEC was an independent predictor of 30-day mortality, LAT was an independent predictor of 1-year mortality (odds ratio 3.573, 95% confidence interval 1.040-12.28; P = 0.042). Conclusions The current study suggests that TAVR may be performed in patients with LAT and SEC with a low risk of embolic complications. While neither was an independent predictor of 30-day mortality, LAT was an independent predictor of 1-year mortality. Larger studies are needed to better study this phenomenon.

Background Limited data exist regarding transcatheter mitral valve replacement (TMVR) for patients with failed mitral valve replacement and repair. Objectives This study sought to evaluate the outcomes of TMVR in patients with failed mitral bioprosthetic valves (valve-in-valve [ViV]) and annuloplasty rings (valve-in-ring [ViR]). Methods From the TMVR multicenter registry, procedural and clinical outcomes of mitral ViV and ViR were compared according to Mitral Valve Academic Research Consortium criteria. Results A total of 248 patients with mean Society of Thoracic Surgeons score of 8.9 ± 6.8% underwent TMVR. Transseptal access and the balloon-expandable valve were used in 33.1% and 89.9%, respectively. Compared with 176 patients undergoing ViV, 72 patients undergoing ViR had lower left ventricular ejection fraction (45.6 ± 17.4% vs. 55.3 ± 11.1%; p < 0.001). Overall technical and device success rates were acceptable, at 92.3% and 85.5%, respectively. However, compared with the ViV group, the ViR group had lower technical success (83.3% vs. 96.0%; p = 0.001) due to more frequent second valve implantation (11.1% vs. 2.8%; p = 0.008), and lower device success (76.4% vs. 89.2%; p = 0.009) due to more frequent reintervention (16.7% vs. 7.4%; p = 0.03). Mean mitral valve gradients were similar between groups (6.4 ± 2.3 mm Hg vs. 5.8 ± 2.7 mm Hg; p = 0.17), whereas the ViR group had more frequent post-procedural mitral regurgitation moderate or higher (19.4% vs. 6.8%; p = 0.003). Furthermore, the ViR group had more frequent life-threatening bleeding (8.3% vs. 2.3%; p = 0.03), acute kidney injury (11.1% vs. 4.0%; p = 0.03), and subsequent lower procedural success (58.3% vs. 79.5%; p = 0.001). The 1-year all-cause mortality rate was significantly higher in the ViR group compared with the ViV group (28.7% vs. 12.6%; log-rank test, p = 0.01). On multivariable analysis, failed annuloplasty ring was independently associated with all-cause mortality (hazard ratio: 2.70; 95% confidence interval: 1.34 to 5.43; p = 0.005). Conclusions The TMVR procedure provided acceptable outcomes in high-risk patients with degenerated bioprostheses or failed annuloplasty rings, but mitral ViR was associated with higher rates of procedural complications and mid-term mortality compared with mitral ViV.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is being increasingly performed in patients with bicuspid aortic valve stenosis (AS).OBJECTIVES: This study sought to compare the procedural and clinical outcomes in patients with bicuspid versus tricuspid AS from the Bicuspid AS TAVR multicenter registry.METHODS: Outcomes of 561 patients with bicuspid AS and 4,546 patients with tricuspid AS were compared after propensity score matching, assembling 546 pairs of patients with similar baseline characteristics. Procedural and clinical outcomes were recorded according to Valve Academic Research Consortium-2 criteria.RESULTS: Compared with patients with tricuspid AS, patients with bicuspid AS had more frequent conversion to surgery (2.0% vs. 0.2%; p = 0.006) and a significantly lower device success rate (85.3% vs. 91.4%; p = 0.002). Early-generation devices were implanted in 320 patients with bicuspid and 321 patients with tricuspid AS, whereas new-generation devices were implanted in 226 and 225 patients with bicuspid and tricuspid AS, respectively. Within the group receiving early-generation devices, bicuspid AS had more frequent aortic root injury (4.5% vs. 0.0%; p = 0.015) when receiving the balloon-expanding device, and moderate-to-severe paravalvular leak (19.4% vs. 10.5%; p = 0.02) when receiving the self-expanding device. Among patients with new-generation devices, however, procedural results were comparable across different prostheses. The cumulative all-cause mortality rates at 2 years were comparable between bicuspid and tricuspid AS (17.2% vs. 19.4%; p = 0.28).CONCLUSIONS: Compared with tricuspid AS, TAVR in bicuspid AS was associated with a similar prognosis, but lower device success rate. Procedural differences were observed in patients treated with the early-generation devices, whereas no differences were observed with the new-generation devices.

Background Recent studies have shown improving survival after cardiac arrest. However, data regarding sex‐based disparities in treatment and outcomes after cardiac arrest are limited. Methods and Results We performed a retrospective analysis of all patients suffering cardiac arrest between 2003 and 2012 using the Nationwide Inpatient Sample database. Annual rates of cardiac arrest, rates of utilization of coronary angiography/percutaneous coronary interventions/targeted temperature management, and sex‐based outcomes after cardiac arrest were examined. Among a total of 1 436 052 discharge records analyzed for cardiac arrest patients, 45.4% (n=651 745) were females. Women were less likely to present with ventricular tachycardia/ventricular fibrillation arrests compared with men throughout the study period. The annual rates of cardiac arrests have increased from 2003 to 2012 by 14.0% ( P trend P trend P trend P trend P P Conclusions Women presenting with cardiac arrests are less likely to undergo therapeutic procedures, including coronary angiography, percutaneous coronary interventions, and targeted temperature management. Despite trends in improving survival after cardiac arrest over 10 years, women continue to have higher in‐hospital mortality when compared with men.

ObjectivesWe examined the clinical, angiographic, and procedural characteristics determining survival after percutaneous coronary intervention (PCI) for cardiogenic shock.BackgroundThe SHOCK (SHould we emergently revascularize Occluded coronaries for Cardiogenic shocK?) trial prospectively enrolled patients with shock complicating acute myocardial infarction (MI). Patients were randomized to a strategy of early revascularization or initial medical stabilization.MethodsPatients randomized to early revascularization underwent PCI or bypass surgery on the basis of predefined clinical criteria. Patients randomized to early revascularization who underwent PCI and had angiographic films available for analysis are the subject of this report (n = 82).ResultsThe median time from MI to PCI was 11 h. The majority of patients had occluded culprit arteries (Thrombolysis In Myocardial Infarction [TIMI] grade 0 or 1 flow in 62%) and multivessel disease (81%). One-year mortality in PCI patients was 50%. Mortality was 39% if PCI was successful but 85% if unsuccessful (p < 0.001). Mortality was 38% if TIMI flow grade 3 was achieved, 55% with TIMI grade 2 flow, and 100% with TIMI grade 0 or 1 flow (p < 0.001). Mortality was 67% if severe mitral regurgitation was documented. Independent correlates of mortality were as follows: increasing age (p < 0.001), lower systolic blood pressure (p = 0.009), increasing time from randomization to PCI (p = 0.019), lower post-PCI TIMI flow (0/1 vs. 2/3) (p < 0.001), and multivessel PCI (p = 0.040).ConclusionsRestoration of coronary blood flow is a major predictor of survival in cardiogenic shock. Benefit appears to extend beyond the generally accepted 12-h post-infarction window. Surgery should be considered in shock patients with severe mitral insufficiency or multivessel disease not amenable to relatively complete percutaneous revascularization.

OBJECTIVES We sought to delineate the angiographic findings, clinical correlates and in-hospital outcomes in patients with cardiogenic shock (CS) complicating acute myocardial infarction. BACKGROUND Patients with CS complicating acute myocardial infarction carry a grave prognosis. Detailed angiographic findings in a large, prospectively identified cohort of patients with CS are currently lacking. METHODS We compared the clinical characteristics, angiographic findings, and in-hospital outcomes of 717 patients selected to undergo angiography and 442 not selected, overall and by shock etiology: left or right ventricular failure versus mechanical complications. RESULTS Patients who underwent angiography had lower baseline risk and a better hemodynamic profile than those who did not. Overall, 15.5% of the patients had significant left main lesions on angiography, and 53.4% had three-vessel disease, with higher rates of both for those with ventricular failure, compared with patients who had mechanical complications. Among patients who underwent angiography, those with ventricular failure had significantly lower in-hospital mortality than patients with mechanical complications (45.2% vs. 57.0%; p = 0.021). Importantly, for patients with ventricular failure, in-hospital mortality also correlated with disease severity: 35.0% for no or single-vessel disease versus 50.8% for three-vessel disease. Furthermore, mortality was associated with the culprit lesion location (78.6% in left main lesion, 69.7% in saphenous vein graft lesions, 42.4% in circumflex lesions, 42.3% in left anterior descending lesions, and 37.4% in right coronary artery lesions), and Thrombolysis In Myocardial Infarction (TIMI) flow grade (46.5% in TIMI 0/1, 49.4% in TIMI 2 and 26% in TIMI 3). CONCLUSIONS Patients who underwent angiographic study in the SHOCK Trial Registry had a more benign cardiac risk profile, more favorable hemodynamic findings and lower in-hospital mortality than those for whom angiograms were not obtained. Patients with CS caused by ventricular failure had more severe atherosclerosis, and a different distribution of culprit vessel involvement but lower in-hospital mortality, than those with mechanical complications. Overall in-hospital survival correlates with the extent of coronary artery obstructions, location of culprit lesion and baseline coronary TIMI flow grade.

Background Transapical approach (TA) is an established access alternative to the transfemoral technique in patients undergoing transcatheter aortic valve replacement (TAVR) for treatment of symptomatic aortic valve stenosis. The impact of prior coronary artery bypass grafting (CABG) on clinical outcomes in patients undergoing TA-TAVR is not well defined. Methods A single center retrospective cohort analysis of 126 patients (male 41%, mean age 85.8 ± 6.1 years) who underwent TA balloon expandable TAVR (Edwards SAPIEN, SAPIEN XT or SAPIEN 3) was performed. Patients were classified as having prior CABG (n = 45) or no prior CABG (n = 81). Baseline clinical characteristics, in-hospital, 30-day, 6 months and one-year clinical outcomes were compared. Results Compared to patients without prior CABG, CABG patients were more likely to be male (62.2 vs. 29.6%, p

Restenosis within tubular-slotted stents is usually treated with repeat PTCA. To understand the mechanisms of lumen enlargement after PTCA of in-stent restenosis, we used quantitative angiography (measurement of % diameter stenosis) and intravascular ultrasound to study 36 restenotic JJIS stents (7 native coronary and 29 vein graft) before and after repeat PTCA. Reference segment and pre- and post-PTCA measurement of external elastic membrane (EEM), stent, and lumen areas were used to calculate (1) plaque area, (2) neointimal hyperplasia (IH) area within the stent (stent—lumen area), (3) % area stenosis of lesion lumen area vs reference lumen area, (4) and % area stenosis of stent area vs reference lumen area. Pre-PTCA Post-PTCA P Angiographic % diameter stenosis 63 ± 19 17 ± 11 l0.0001 Reference lumen area (mm2) 9.8 ± 3.3 Lesion EEM area (mm2) 20.8 ± 6.7 24.4 ± 7.9 l0.0001 Stent area (mm2) 7.4 ± 3.1 9.9 ± 3.7 l0.0001 Lesion lumen area (mm2) 2.2 ± 1.2 6.7 ± 2.2 l0.0001 Lesion plaque area (mm2) 18.6 ± 6.5 18.0 ± 6.7 NS IH area within stent (mm2) 5.3 ± 3.3 3.2 ± 2.5 l0.0001 % Area stenosis lumen vs reference 76.1 ± 14.0 31.0 ± 22.0 l0.0001 % Area stenosis stent vs reference 23.3 ± 26.9 -1.9 ± 33.1 l0.0001 Pre-intervention, 80% of lesions had a minimum stent area less than the reference lumen area, compared to 50% post-PTCA (p = 0.0028). Importantly, 55% of lumen enlargement after repeat PTCA was the result of additional stent expansion and 45% was the result of extrusion of tissue through the stent (decreased IH area within the stent). There was no evidence of compression of neointimal tissue post-PTCA (no change in overall plaque area). Dissections were uncommon (occurring in 17% of lesions after PTCA) and were minor in nature without clinical consequences. We Conclude:Instent restenosis appears to be the result of inadequate primary stent expansion and superimposed neointimal hyperplasia. The mechanism of successful PTCA of in-stent restenosis is a combination of additional stent expansion (increased stent area) and neointimal tissue extrusion through the stent. PTCA of in-stent restenosis results in a relatively high residual stenosis (angiographic % diameter stenosis = 17 ± 11 and ultrasound % area stenosis = 31 ± 22); this may contribute to more frequent repeat episodes of restenosis.

To assess the late (3 years) clinical outcomes of JJIS stent (S) placement in the treatment of native coronary(NC) and saphenous vein graft (SVG) lesions, we compared baseline factors, procedural results and late clinical events in 112 pts (122 lesions) with native and 118 pts (153 lesions) with SVG lesions treated with S at the Washington Hospital Center. Pts with SVG lesions were older, had more frequent multivessel disease, history of prior MI, ostial and denovo lesions and lower ejection fractions (all p l 0.005). The initial and final % stenosis, procedural success and major complications (death, Q wave MI, CABG) were similar between the 2 groups. Clinical events Native 1/3 yr SVG 1/3 yr P value (log-rank) Death (%) 0/1.5 8/22 0.0003 Q-wave MI (%) 1/1 5/8 0.06 TLR(%) 26/29 28/49 0.08 Non-TLR (%) 0/9 10/17 0.02 TLR = target lesion revascularization Download : Download high-res image (52KB) Download : Download full-size image (repeat PTCA or CABG) and EFS = event free survival (freedom from death, Q-wave MI, and TLR). During the first year after S placement, SVG lesions (compared with NC) had higher mortality and Q-wave MI. similar TLR and greater non-TLR events. Between 1 and 3 years, in SVG pts there was a further dramatic increase in mortality and TLR resulting in a 3-year actuarial EFS of only 37% (see figure). In contrast, NC behavior was stable between 1 and 3 years with no further mortality, Q-wave MI, or TLR, but a 10% incidence of non-TLR events. In conclusion:Despite similar procedural results, SVG vs native pts treated with S manifested disparate late clinical responses. Disturbingly, in SVG pts there was progressive mortality(in part due to increased pt morbidity) and additional TLR events after the first year of S implantation (ie. “late” restenosis) causing a striking attrition in 3 year EFS.

Although well established biologic, anatomic, and angiographic predictors of adverse clinical events are known for PTCA, there are a paucity of data after stent (S) implantation. Therefore we compared independent predictors for adverse clinical events (procedural failure, restenosis, and late complications) after S (N = 205) vs PTCA (N = 202) treatment from the randomized multicenter St ent Res tenosis S tudy (STRESS) by performing multivariate logistic analysis. Independent Predictors PTCA (OR, Pvalue) 5tent (OR, Pvalue) Procedure Failure: (final stenosis g 50% andlor death/MI/CABG andlor bailout S) Dissection (362, l 0.005) Final MLD (006, P l 0.005) Angiographic Restenosis: ( ≥ 50% diameter stenosis at follow-up angiogram) Diabetes (2.84, Pl 005) Relerence size (0.31, Pl 0.05) (0.47, P l 0.05) LAD (2.41, P l 005) Final MLD Late Complications: (out-ai-hospital death/ MI/CABG or repeat PTCA, mean follow-up time = 8.8 ± 3.4 months) None Final MLD (0.32, P l 005) Recent( l 6 weeks)M I (2.71, P l 005) In S pts, final minimal lumen diameter (MLD) strongly influenced procedure failure, angiographic restenosis, and late complications. In PTCA pts, postPTCA dissection predicted procedural failure; diabetes, reference size, and LAD predicted restenosis: there were no predictors of late complications. In conclusion The multivariate analysis of STRESS pt outcomes indicates 1) predictors for adverse clinical events were different for Sand PTCA, 2) S neutralized the deleterious impact of biologic and anatomic factors on angiographic restenosis and 3)final MLD after S placement, an operator-controlled variable, strikingly predicted all adverse clinical outcomes. Therefore, meticulous operator attention to optimize final MLD after S placement with appropriate adjunct PTCA may further improve clinical outcomes.

No-reflow phenomenon after angioplasty or atherectomy may result in important ischemic complications. No-reflow phenomenon is related to distal embolization of microparticulate material and/or spasm in the microcirculation. Maximal vasodilatation of the coronary microcirculation may prevent or terminate episodes of no-reflow phenomenon. In this preliminary study, we evaluated the vasodilatory capacities of agents commonly used during coronary procedures, The coronary flow reserve (CFR = hyperemic/basal flow velocity) was measured with 0.018” Doppler FloWire in coronary arteries with l50% diameter stenoses (6 RCA, 4 LAD, and 10 LCX) in 20 patients (mean age = 64 ± 7 years; 15 men) undergoing angiography (n = 6) or angioplasty (n = 14) in another coronary artery. Random paired CFR measurements in the same artery were obtained with intracoronary adenosine, nitroglycerin (NTG), verapamil, and contrast agents (Hypaque, Hexabrix, and Optiray), with blood injection as a control. After each measurement, basal flow conditions were restored before subsequent test injections. At the doses chosen, there were no hemodynamic or conduction abnormalities, which could influence coronary flow responses. adenosine (6 or 12 μ g) verapamil (100 μ g) verapamil (200 μ g) NTG (50 μ g) NTG (200 μ g) Hypaque (6 ml) Blood (6 ml) CFR * 2.2 ± 0.9 ** 14 ± 0.3 1.5 ± 03 1.7 ± 0.4 1.8 ± 0.5 2.1 ± 0 8 1.2 ± 0 1 Duration * 29 ± 9 *** 58 ± 63 77 ± 57 21 ± 7 22 ± 9 35 ± 10 9 ± 5 * p l 0.001 by ANOVA and multiple pairwise comparisons with Bonferroni correction, using adenosine as the comparison group ** p l 0,001 vs. all others except Hypaque *** p l 0.05 vs. all others except verapamil (100 μ g ) and Hypaque: Duration of hyperemic response in seconds Among different contrast agents, there was no difference in CFR, although duration of hyperemia was significantly longer with Hypaque vs. other contrast agents (p l 0.001 by ANOVA). We conclude that adenosine and Hypaque had the highest vasodilatory effect among the agents tested. These agents should be further studied for a potential benefit in the prevention or treatment of no-reflow phenomenon during angioplasty and atherectomy procedures.

Balloon angioplasty of aorto-ostial (AO, ≤3 mm from aorta) saphenous vein graft (SVG) lesions has been associated with suboptimal results and high restenosis frequency. New angioplasty devices are being utilized to treat AOSVG lesions but comparative efficacy has not been established. Therefore, we compared the early procedural results and late clinical outcomes of 85 patients (90 lesions) treated with the Palmaz-Schatz stent (S) and 34 pts (41 lesions) treated with directional atherectomy (DCA). There was no difference in pt demographics between the 2 groups. TLR = target lesion revascularization, procedural success = final % stenosis g50% and no major complications (death, MI, CABG), and event free survival = freedom from major complications or repeat PTCA at follow-up. stent DCA P value Angiographic Findings : Ulceration (%) 16.3 0.0 0.005 Lesion length/Reference size (mm) 8.9 ± 6.0/3.8 ± 0.7 5.3 ± 2.9/3.7 ± 0.7 0.0002/0.8 Acute gain (mm)/Final % stenosis 2.4 ± 0.9/4+7 2.1+0.7/13 ± 14 0.13/0.004 Clinical Findings : Major complications (%) 2.4 5.9 0.32 Procedural success (%) 96.5 94.1 0.62 %TLR @ 6/12 months 20.6/32.8 30.8/41.7 0.05 % Event free survival 6/12 months 73.6/52.8 57.8/42.4 0.15 In conclusion 1) Despite a higher frequency of adverse lesion characteristics including ulceration and longer lesions, S placement achieved improved angiographic results (lower final % stenosis) compared to DCA. 2) Similarly, late clinical outcomes favored S (vs DCA) with fewer TLR events and a higher event free survival. 3) Nevertheless, the overall results of these new device modalities (S and DCA) for AO-SVG lesions are discouraging (l50% 12-month event free survival) and mandate further therapy refinements to improve late clinical outcomes.

In an attempt to understand better the pathology and results of transcatheter therapy of vein graft lesions, we performed intravascular ultrasound and quantitative angiographic analysis of 244 nonostial vein graft lesions. Preand post-intervention lesion site external elastic membrane (EEM), lumen, and plaque cross-sectional areas, calcium, and % cross-sectional narrowing (plaque/EEM area) were compared to a proximal reference site (most normal looking cross-section within 10 mm proximal to the lesion). Lesions were divided into two groups: 98 lesions with lesion EEM ≤ reference (“fibrotic”) ; 146 lesions with lesion EEM g reference (“ectatic”) . There was no difference in vein graft age, lesion length, or history of restenosis between the two groups. Fibrotic Ectatic p Reference EEM area (mm 2 ) 19.8 ± 7.3 18.6 ± 5.9 NS Reference lumen area (mm 2 ) 10.6 ± 4.4 10.6 ± 3.6 NS Reference plaque area (mm 2 ) 10.6 ± 10.0 8.0 ± 3.8 0.0052 Lesion site pre-intervention Angiographic % diameter stenosis 63 ± 20 60 ± 22 NS EEM area (mm 2 ) 16.1 ± 6.8 25.8 ± 10.6 l0.0001 Lumen area (mm 2 ) 2.6 ± 2.2 3.6 ± 2.7 0.0016 Plaque + media area (mm 2 ) 13.5 ± 6.4 21.9 ± 8.4 l0.0001 Arc of calcium (°) 61 ± 83 26 ± 54 0.001 Lesion/Reference plaque area 1.6 ± 0.7 3.1 ± 1.3 l0.0001 Lesion site post-intervention Angiographic %diameter stenosis 17 ± 17 12 ± 19 0.0903 Lumen area (mm 2 ) 6.7 ± 2.5 8.5 ± 2.9 0.0001 Follow-up angiographic %diameter stenosis 54 ± 33 35 ± 32 0.0329 16% of “fibrotic” had a lesion plaque area l reference. Importantly, (1) post-intervention minimum lumen areas were significantly smaller in fibrotic lesions, and (2) at follow-up the angiographic % diameter stenosis was significantly larger in fibrotic lesions. We Conclude: 40% of vein graft lesions may be classified as “fibrotic” . “Fibrotic” lesions have a decreased plaque burden and more lesion-associated calcium. Lumen compromise results from vessel retraction (?periadventitial fibrosis). In these lesions it may be more difficult to achieve optimal final lumen dimensions resulting in more frequent restenosis.

Previously, we reported the high incidence of ischemic complications due to distal embolization (DE) following extraction atherectomy (TEC) of degenerated saphenous vein grafts (DSVG: grafts with lumen ectasia or irregularities comprising ≥50% of the graft length), frequently caused by adjunct PTCA (Group I). To assess whether a staged strategy (initial stand-alone TEC ± lyric therapy, followed by coumadin and stenting 1–2 months later) could reduce ischemic complications, we performed a pilot study in 28 pts with DSVG (Group II). Demographics and graft age (100 ± 47 vs. 99 ± 42 months) were similar, except for more recent MI in Group II (58.3% vs. 22.7%, P = 0.03). Group I (n = 44) Group II (n = 28) % DS (Pre/Final) 79 ± 14/30 ± 24 * 80 ± 17/45 ± 19 DE (%) 22.7 ** 10.7 Any In-hospital Complications 11.4% *** 0% Death/CABG/MI (%) 6.8/2.3/4.5 0/0/0 DS = diameter stenosis * p l 0.001 ** p = 0.20 *** p = 0.15 vs. Group II Preliminary Follow-up Among 27 pts in Group II eligible for follow-up (g 1 month), there were no major ischemic complications. There were 4 total occlusions [1 non-Q wave MI at 4 months and 3 silent occlusions at 6 weeks (1) and 2 months (2)]. 9 without clinical indication for additional therapy, 11 staged procedures with stenting (follow-up % DS = 56 ± 30%), and 3 without significant stenosis on follow-up angiography. We conclude that this staged angioplasty strategy in degenerated saphenous vein graft lesions: 1) may reduce distal embolization, but most importantly , avoids major in-hospital ischemic complications during the initial procedure: but 2) at the expense of ≈15% graft occlusions, which occurred more than 6 weeks after the initial procedure: and 3) prevented any deaths either during the initial procedure or during the follow-up period. These results underscore the importance of early (1 month) follow-up in all patients undergoing this staged TEC, followed by stent procedure in treating complex degenerated saphenous vein graft lesions.

Previous studies have shown that (1) stents reduce restenosis, (2) stents do not recoil, and (3) geometric remodeling may be an important contributing factor in restenosis. Therefore, to understand the mechanisms by which stents reduce restenosis, we analyzed serial (post-intervention and follow-up @ 5.0 ± 2.9 months) intravascular ultrasound and quantitative angiographic studies in 33 stented lesions and compared the results to 135 nonstented lesions treated with various devices (30 PTCA, 57 directional and 26 rotational atherectomy, and 22 excimer laser angioplasty). Post-intervention and followup external elastic membrane (EEM), stent, and lumen areas were used to calculate (1) plaque area, (2) late lumen loss (Δ lumen area), (3) geometric remodeling (Δ EEM area or Δ stent area in stented lesions and Δ EEM area in nonstented lesions), and (4) tissue growth Δ (stent-lumen) area in stented lesions and Δ plaque area in nonstented lesions. Stent Non-stent p Post-intervention EEM area (mm 2 ) 29.3 ± 118 204 ± 65 l 0.0001 Lumen area (mm 2 ) 8.5 ± 39 6.1 ± 2.4 l 0.0001 Plaque area (mm 2 ) 20.9 ± 9.3 14.3 ± 5.7 l 0.0001 Angiographic % diameter stenosis 9 ± 18 19 ± 14 0.0011 Follow-up EEM area (mm 2 ) 27.7 ± 9.5 187 ± 6.0 l 0.0001 Lumen area (mm 2 ) 6.5 ± 4.4 35 ± 3.0 l 0.0001 Plaque area (mm 2 ) 22.0 ± 8.0 15.2 ± 5.5 l 0.0001 Angiographic % diameter stenosis 36 ± 18 51 ± 26 0.005 Restenosis # (%) 8(23%) 77(57%) 0.0017 Late lumen loss (mm 2 ) 2.4 ± 2.6 2.6 ± 2.7 NS Remodeling (mm 2 ) 02 ± 13 1.7 ± 2.9 0.0061 Tissue growth (mm 2 ) 2.2 ± 2.4 1.0 ± 2.3 0.0076 Geometric remodeling is less (0.2 ± 1.3 vs 1.7 ± 2.9 mm 2 ) and tissue growth is greater (2.2 ± 2.4 vs 1.0 ± 2.3 mm 2 ) in stented lesions than in nonstented lesions. We Conclude Stents reduce restenosis by achieving a better primary (post-procedural) result and by eliminating geometric remodeling. The elimination of geometric remodeling offsets a stent-related increase in plaque mass (tissue growth or neointimal hyperplasia) to prevent restenosis.