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Objectives: A large comprehensive analysis of transcatheter aortic valve replacement (TAVR) was performed for failed stentless bioprostheses., Background: Valve-in-valve (ViV) transcatheter aortic replacement (TAVR) is an alternative to redo surgery for patients with a failing aortic bioprosthesis., Methods: Unadjusted outcome data were collected from the VIVID (Valve-in-Valve International Data) registry between 2007 and 2016 from a total of 1,598 aortic ViV procedures (291 stentless, 1,307 stented bioprostheses)., Results: Bioprosthetic failure was secondary to aortic regurgitation in 56% of stentless and 20% stented devices (p < 0.001). ViV-TAVR access was transfemoral in 71.1% stentless and 74.2% stented ViV-TAVR. Self-expanding devices were more frequently used in stentless ViV-TAVR (56.0% vs. 39.9%; p = 0.05), but there was no difference between balloon-expanding and self-expanding TAVR devices for stented ViV-TAVR (48.6% vs. 45.1%). The degree of oversizing for all mechanisms of bioprosthesis failure was 9 ± 10% for stentless ViV-TAVR vs. 6 ± 9% for stented ViV-TAVR (and 8 ± 10% for stentless ViV-TAVR vs. 3 ± 9% for stented ViV-TAVR in patients with predominant aortic regurgitation; both p < 0.001). Initial device malposition (10.3% vs. 6.2%; p = 0.014), second transcatheter device (7.9% vs. 3.4%), coronary obstruction (6.0% vs. 1.5%), and paravalvular leak occurred more frequently in stentless ViV-TAVR (all p < 0.001). Hospital stay duration (median 7 days) was no different, and 30-day (6.6% vs. 4.4%; p = 0.12) and 1-year mortality year (15.8% vs. 12.6%; p = 0.15) were numerically higher, but not statistically different, after stentless ViV-TAVR., Conclusions: Stentless ViV-TAVR is associated with greater periprocedural complications (initial device malposition, second transcatheter device, coronary obstruction, paravalvular leak), but no difference in 30-day and 1-year outcome., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Drug-eluting stents (DESs) exhibit delayed endothelialization compared with bare metal stents. Adverse late vessel wall remodeling and inflammation have also been attributed to the drug/polymer coating. Recent registry data suggesting increased risk of DES thrombosis in routine clinical practice compared with previous clinical trial experience has led to concerns regarding long-term safety of these devices. We sought to determine the frequency, etiology, and clinical outcomes of stent thrombosis over 1 year in a large patient cohort treated with coronary DESs. Consecutive patients (n = 1,213) who received >or=1 DES between April 2003 and June 2004 at the Mayo Clinic (Rochester, Minnesota) were identified. Medical records pertaining to all deaths, major adverse cardiac events, and/or repeat coronary angiograms after DES placement were evaluated to identify cases of stent thrombosis. Mean follow-up was 12 months. Eleven cases (0.9%, 95% confidence interval 0.4 to 1.3) of stent thrombosis were identified; 4 were acute (<24 hours), 5 were subacute (<30 days), and 2 were late (30 days to 1 year). Normal flow was successfully restored in 7 of 8 cases where this was attempted. There were 10 myocardial infarctions and 2 deaths attributable to stent thrombosis. Eight patients were still alive at 1 year after developing stent thrombosis. In conclusion, early clinical experience with DESs in routine clinical practice indicates a low risk of stent thrombosis, within the range previously reported for bare metal stent thrombosis. Further studies with longer follow-up will be required to definitively address long-term safety concerns.

A 31-year-old male with pulmonary atresia, ventricular septal defect presented with exercise intolerance and severe cyanosis. A restrictive coronary-pulmonary artery fistula was identified as the main source of pulmonary blood flow. We report transcatheter stent implantation in the fistula to augment pulmonary flow as a palliative management option in the adult patient with complex congenital heart disease., (Copyright 2001 Wiley-Liss, Inc.)

Background: The benefits of thrombolytic therapy for acute myocardial infarction (AMI) are limited by reocclusion of the infarct-related artery, which occurs in 25% to 30% of patients after successful reperfusion. The frequency of reocclusion after balloon angioplasty and stenting in this setting is less well documented. The aim of this study was to analyze the frequency and timing of reocclusion after percutaneous transluminal coronary angioplasty (PTCA) and stent placement during AMI from all available studies compared with previously published reocclusion rates after thrombolysis., Methods and Results: The previously published thrombolysis data included 4231 patients in 19 studies with > or = 75 patients. Only PTCA studies with > or = 50 patients and stent studies with > or = 30 patients, in which routine angiographic follow-up was obtained in > or = 60% of patients, were included. Ten PTCA studies with a total of 1943 patients were analyzed, with follow-up angiography in 1391 (72%). Reocclusion rates ranged from 5% to 16.7%. The stent studies included 698 patients from 7 studies, with follow-up angiography in 92%. Reocclusion rates ranged from 0% to 6%. With the use of logistic regression analysis with allowance for overdispersion, there was a significantly lower rate of reocclusion after PTCA (odds ratio, 0.38; confidence interval, 0.24 to 0.57; P <.0001) and stent placement (odds ratio, 0.11; confidence interval, 0.05 to 0.22; P <.0001) compared with thrombolysis. Reocclusion after stent placement was lower than after PTCA (odds ratio, 0.28; confidence interval, 0.13 to 0.6; P <.0001)., Conclusions: Reocclusion after PTCA and stent placement during AMI is less frequent than after thrombolysis. This may contribute to the superior outcome of patients treated with PTCA and stent placement in this setting.

Background: The role of coronary stenting in the treatment of stenoses in small coronary arteries with use of 2.5-mm stents is not well defined., Methods and Results: Between January 1995 and August 1999, 651 patients with stenoses in small coronary arteries were treated with 2.5-mm stents (n = 108) or 2.5-mm conventional balloon angioplasty (BA) (n = 543). Patients who received treatment with both 2.5-mm and > or =3.0-mm stent placement or balloons were excluded. Procedural success and complication rates as well as 1-year follow-up outcomes were examined. Baseline clinical characteristics were similar between the two groups, except patients in the stent group were more likely to have hypertension and a family history of coronary artery disease and less likely to have prior myocardial infarction. Angiographic success rates were higher in the stent group (97.2% vs 90.2%, P =.02). In-hospital complication rates were comparable between the two groups. Among successfully treated patients, 1-year follow-up revealed no significant differences in the survival (96.2% vs 95.2%, P =.89) or the frequency of Q-wave myocardial infarction (0% vs 0.4%, P =.60) or coronary artery bypass grafting (8.4% vs 6.8%, P =.89) between the stent and BA groups, respectively. However, patients in the stent group were more likely to have adverse cardiac events (35.4% vs 22.1%, P =.05). Stent use after excluding GR II stent use, however, was not independently associated with reduced cardiac events at follow-up (relative risk 1. 3 [95% confidence interval 0.8-2.3], P =.30)., Conclusions: Intracoronary stent implantation of stenoses in small coronary arteries with 2.5-mm stents can be carried out with high success and acceptable complication rates. However, compared with BA alone, stent use was not associated with improved outcome through 1 year of follow-up.

Background: This study applied the New York State conventional coronary angioplasty (PTCA) model of clinical outcomes to evaluate whether it has relevance in the current era of stent implantation. The model was developed in 62 670 patients treated with conventional PTCA from 1991 to 1994 to risk adjust mortality and bypass surgery after PTCA. Since then, stents have become the dominant form of intervention. Whether that model remains relevant is uncertain., Methods and Results: All patients undergoing stenting at the Mayo Clinic from 1995 to 1998 were analyzed for in-hospital mortality, bypass surgery performed after attempted stenting, and longer-term mortality. No patients were excluded. The New York model was used to risk adjust and predict in-hospital and follow-up mortality. There were 3761 patients with 4063 procedural admissions for stenting; 6,472 target vessel segments were attempted, and 96.1% of procedures were successful. With the New York multivariable risk factor equation, 79 in-hospital deaths were expected (1.95%); 66 deaths (1.62%) were observed. The New York model risk score in a logistic regression model was the most significant factor associated with in-hospital mortality (OR, 1.86; P<0.001). During a mean follow-up of 1.2+/-1.0 years, there were 154 deaths. Multivariable analysis documented 6 factors associated with subsequent mortality; New York risk score was the most significant (chi(2)=16.64, P=0.0001)., Conclusions: Although the New York mortality model was developed in an era of conventional angioplasty, it remains relevant in patients undergoing stenting. The risk score derived from that model is the variable most significantly associated with not only in-hospital but also longer-term outcome.

Objectives: The aim of this study was to evaluate the immediate and long-term outcome of intracoronary stent implantation for the treatment of coronary artery bifurcation lesions., Background: Balloon angioplasty of true coronary bifurcation lesions is associated with a lower success and higher complication rate than most other lesion types., Methods: We treated 131 patients with bifurcation lesions with > or =1 stent. Patients were divided into two groups; Group (Gp) 1 included 77 patients treated with a stent in one branch and percutaneous transluminal coronary angioplasty (PTCA) (with or without atherectomy) in the side branch, and Gp 2 included 54 patients who underwent stent deployment in both branches. The Gp 2 patients were subsequently divided into two subgroups depending on the technique of stent deployment. The Gp 2a included 19 patients who underwent Y-stenting, and Gp 2b included 33 patients who underwent T-stenting., Results: There were no significant differences between the groups in terms of age, gender, frequency of prior myocardial infarction (MI) or coronary artery bypass grafting (CABG), or vessels treated. Procedural success rates were excellent (89.5 to 97.4%). After one-year follow-up, no significant differences were seen in the frequency of major adverse events (death, MI, or repeat revascularization) between Gp 1 and Gp 2. Adverse cardiac events were higher with Y-stenting compared with T-stenting (86.3% vs. 30.4%, p = 0.004)., Conclusions: Stenting of bifurcation lesions can be achieved with a high success rate. However, stenting of both branches offers no advantage over stenting one branch and performing balloon angioplasty of the other branch.

Objectives: The aim of our study was to compare the in-hospital and long-term clinical outcomes of direct coronary stenting with balloon predilation followed by stent placement., Background: With improvement in stent designs, the practice of direct stenting without balloon predilation has become more widespread., Methods: We analyzed the Mayo Clinic Coronary Intervention data base between January 1, 1995 and March 5, 1999 and identified 777 patients who were treated with direct stenting (DS) and 3,176 patients treated with balloon angioplasty plus stenting (BA+S)., Results: The procedural success rates between the DS and BA+S groups were not significantly different (96.3% vs. 96.4%). The ability to deliver the stent in a subgroup of patients who had DS was 95%, with 5% requiring crossover to predilation. Multivariate analysis showed no significant differences with respect to in-hospital death (odds ratio [OR] 0.9, 95% confidence interval [CI] 0.5 to 1.8), in-hospital myocardial infarction (OR 0.9, 95% CI 0.6 to 1.2) or revascularization (OR 0.7, 95% CI 0.4 to 1.5) in the DS compared with the BA+S group. Long-term outcomes were not significantly different between the DS and BA+S groups. The procedural duration was significantly shorter in the DS group, and there was a decreased utilization of contrast agent, balloons and wires., Conclusions: The in-hospital and long-term clinical outcomes in patients undergoing a coronary intervention are equivalent when comparing stenting without balloon predilation with balloon angioplasty followed by stenting. Direct stenting is associated with decreased utilization of contrast agent and equipment and shorter procedure times. A randomized study should be performed to better determine the impact of this technique on short- and long-term procedural outcomes.

Objectives: The study compared the safety and efficacy of ticlopidine with clopidogrel in patients receiving coronary stents., Background: Stent thrombosis is reduced when ticlopidine is administered with aspirin. Clopidogrel is similar to ticlopidine in chemical structure and function but has fewer side effects; few data are available about its use in stent patients., Methods: We compared 30-day event rates in 500 consecutive coronary stent patients treated with aspirin and clopidogrel (300 mg loading dose immediately prior to stent placement, and 75 mg/day for 14 days) to 827 consecutive stent patients treated with aspirin and ticlopidine (500 mg loading dose and 250 mg twice daily for 14 days)., Results: Patients treated with clopidogrel had more adverse clinical characteristics including older age, more severe angina, and more frequent infarction within the prior 24 h. Nonetheless, mortality was 0.4% in clopidogrel patients versus 1.1% in ticlopidine patients; nonfatal myocardial infarction occurred in 0% versus 0.5%, stent thrombosis in 0.2% versus 0.7%, bypass surgery or repeat angioplasty in 0.4% versus 0.5%, and any event occurred in 0.8% versus 1.6% of patients, respectively (p = NS). Based on the observed 30-day event rate of 1.6% with ticlopidine, the statistical power of the study was 43% to detect an even rate of 0.5% with clopidogrel, and 75% to detect an event rate with of 4% with clopidogrel, with a p value of 0.05., Conclusions: These data indicate that clopidogrel can be safely substituted for ticlopidine in patients receiving coronary stents.

Quantitative coronary angiography (QCA) and intracoronary ultrasound (ICUS) are methods for anatomic assessment of stent deployment. Intracoronary Doppler is primarily a method for the physiologic assessment of coronary stenoses. It correlates well with traditional noninvasive measurements of lesion significance. Intracoronary Doppler was used for the anatomic assessment of de novo coronary artery stenosis with variable success; however, its use for anatomic assessment of adequate stent deployment is unavailable. A rapid, automated software program was developed based on a modified continuity equation to calculate the maximal in-stent percent area stenosis by comparing the maximal in-stent velocity to an average reference velocity (proximal and distal). This study was designed to compare the Doppler method of an anatomic assessment with QCA and ICUS in 15 patients. Physiologic success of stent deployment was determined by the distal coronary flow reserve to 24 to 36 microg of intracoronary adenosine. Following successful stent deployment, distal coronary flow reserve increased significantly from a baseline of 1.6 +/- 0.5 to 2.9 +/- 1.1. There was a significant correlation between the maximal in-stent percent area stenosis as measured by Doppler and both QCA (r = 0.78, p <0.01) and ICUS (r = 0.84, p <0.01). This study demonstrates that maximal in-stent percent area stenosis can be measured by intracoronary Doppler and a novel software program. The intracoronary Doppler guidewire method can assess the adequacy of stent deployment using both anatomic and physiologic principles and may supplement other quantitative methodologies.

In patients receiving coronary stents treated with aspirin and coumadin, the peak incidence of stent thrombosis occurs on the fifth and sixth days following the implantation procedure. Little is known about the timing of stent thrombosis in patients treated with aspirin and ticlopidine. We compared the timing of coronary stent thrombosis in patients treated with ticlopidine and aspirin with the timing in those receiving coumadin and aspirin. A retrospective databank analysis was performed and 39 patients were identified who experienced stent thrombosis after successful coronary stent implantation. Of these, 21 had been treated with ticlopidine and aspirin and 18 with coumadin and aspirin therapy. The median time from stent implantation to stent thrombosis in the ticlopidine and aspirin group was 12 hours (interquartile range 6 to 72 hours) compared with 4 days in the coumadin and aspirin group (interquartile range 21 to 68 hours) (p <0.0001). There was no significant difference between the timing of stent thrombosis in patients treated with abciximab in addition to ticlopidine and aspirin (median 17 hours, interquartile range 6 to 29) versus ticlopidine and aspirin patients who did not receive abciximab (median 11 hours, interquartile range 9 to 12, p = 0.57). Thus, in patients who receive coronary stents, stent thrombosis occurs much earlier after the procedure in patients treated with ticlopidine and aspirin than in patients treated with anticoagulation therapy.

Although adjunctive abciximab therapy improves outcome after angioplasty or atherectomy, there are few data demonstrating its benefit for intracoronary stent implantation. We characterized patients receiving abciximab for stent placement in our practice and determined the impact of abciximab on outcome. Abciximab was introduced to our practice in April 1995 for percutaneous revascularization. Demographic, clinical, and angiographic variables that were independently associated with the use of abciximab for stent placement through 1996 (abciximab era) were examined. We then examined among all patients receiving stents from 1992 through 1996 (preabciximab and abciximab eras) whether the use of abciximab was independently associated with improved outcome (death, nonfatal Q-wave myocardial infarction, coronary bypass surgery, or target vessel percutaneous revascularization) in the hospital and at 30 days. The 30-day event rate was 7% for those who did or did not receive abciximab. The following characteristics were independently associated with the use of abciximab for stent placement in the abciximab era: thrombus before stent placement (chi-square 50.5), > or =2 stents implanted (chi-square 10.8), stent in venous graft (chi-square 7.4), calcific lesion (chi-square 5.8), and hypertension (chi-square 5.5). Among all patients receiving stents in the preabciximab and abciximab eras (n=1,859), the presence of these characteristics was independently associated with worse outcome. Abciximab, however, did not improve outcome in the hospital (odds ratio [95% confidence interval]=0.96 [0.58 to 1.58]) or at 30 days (0.87 [0.53 to 1.41]), even after adjusting for these characteristics. Abciximab for stent placement was used in high-risk patients in our practice but was not associated with improved outcome.

Objectives: To evaluate the outcome of patients undergoing multivessel coronary stent implantation., Background: Percutaneous transluminal coronary angioplasty has been shown to be an effective treatment for multivessel coronary artery disease, although the need for repeat revascularization continues to be a limitation. Intracoronary stent placement has been shown to reduce the need for subsequent revascularization., Methods: Seventy-seven patients without prior coronary artery bypass grafting (CABG) undergoing multivessel coronary revascularization in which stents were placed in all treated segments over a 5 year period at our institution were identified. Clinical and angiographic characteristics and outcomes were analyzed., Results: One hundred and eighty-eight coronary lesions were successfully treated (2.1+/-0.3 treated vessels/patient, 2.4+/-0.6 treated lesions/patient) using 2.8+/-1.2 stents/patient (range 2-9) and 1.4+/-0.8 stents/vessel (range 1-6). Procedural success rate [angiographic success without in-hospital death, Q-wave myocardial infarction (Q-wave MI) or CABG] was achieved in 76 of 77 patients (98.7%). Anatomically complete revascularization was achieved in 46 (59.7%) patients. Modified ACC/AHA Type B2 and C lesions comprised 75.5% of the 188 lesions. The left anterior descending artery was treated in 57 (74.0%) patients. The indication for stent placement was dissection or threatened/abrupt closure in 54 segments (28.8%). In-hospital events included death in one patient (1.3%); no patient suffered a Q-wave MI or required CABG. Stent occlusion occurred in two (2.6%) patients, and repeat percutaneous intervention of the target vessel was also required in these two patients. Any of these adverse events occurred in three (3.9%) patients. No further events occurred after hospital discharge in the 30 days after the procedure. Of hospital survivors (n=76), adverse events at 6 months included death in two patients (2.6%), MI in two (2.6%), CABG in six (7.9%); nine (11.8%) patients underwent repeat percutaneous intervention and 15 (19.7%) underwent any revascularization., Conclusions: Multivessel coronary stent placement is associated with an excellent procedural success rate despite a high rate of adverse lesion characteristics, and a low rate of death or MI during follow-up. The need for further revascularization compares favorably with published rates with multivessel PTCA and single stent implantation for discrete de novo lesions.

Background: Devices designed to facilitate or replace conventional percutaneous transluminal coronary angioplasty have been introduced in recent years., Objectives: To characterize the changes in percutaneous coronary interventional practice over 16 years and to assess the relative use of these new devices., Methods: We performed a retrospective analysis of all patients who underwent percutaneous coronary revascularization at Mayo Clinic, Rochester, Minn, during a 16-year period (1980-1995) and characterized the changes in procedural and clinical factors., Results: The number of coronary interventional procedures performed increased from 38 in 1980 to 1284 in 1995. Atherectomy and laser angioplasty were incorporated in 1988; their use peaked in 1994 (17% of procedures) but decreased to 9.9% by 1995. In contrast, the use of intracoronary stents has increased steadily since 1990. By 1995, intracoronary stents were placed in 48.2% of procedures. The success rate improved from 55.3% in 1980 to 91.4% in 1995, although patients were older (51 +/- 10 [mean +/- SD] years in 1980 vs 63 +/- 12 years in 1995), had more extensive coronary artery disease (0% with multivessel disease in 1980 vs 47.4% in 1995), had more complex lesions, and often underwent intervention in the peri-infarction setting (2.6% of procedures in 1980 vs 17% in 1995). The rate of referral to emergency coronary bypass surgery after percutaneous procedures declined from 5.2% in 1980 to 0.4% in 1995., Conclusions: Current coronary interventional practice is expanding and improving. In contrast to intracoronary stents that have greatly affected current practice, other new devices are used infrequently. Conventional angioplasty, with or without intracoronary stents, remains the dominant treatment strategy.