Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients: 5-Year Outcomes of the SURTAVI Randomized Clinical Trial.

Importance: In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective: To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants: SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention: Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures: The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results: A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm2 vs 1.8 [0.6] cm2; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance: Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.

Long-Term Health Benefit of Transcatheter Aortic Valve Replacement in Patients With Chronic Lung Disease.

OBJECTIVES: This study sought to characterize the long-term effect of chronic lung disease (CLD) on mortality, clinical outcomes, quality of life, and health benefits after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis. BACKGROUND: The long-term effect of CLD after TAVR is unknown. METHODS: Prevalence and severity of CLD was determined at baseline in high- and extreme-risk patients with aortic stenosis from the CoreValve US Pivotal Trial. Clinical outcomes and health status were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS). A favorable health benefit was defined as alive with a KCCQ-OS ≥60 and stability (<10-point decrease) or improvement in the KCCQ-OS from baseline. RESULTS: CLD was present in 55% (20% mild, 13% moderate, 22% severe) of the 1,030 patients studied. All-cause mortality was higher in patients with moderate and severe CLD at 1 year (19.6% mild, 28.1% moderate, 26.9% severe CLD vs. 19.2% non-CLD; p = 0.030) and 3 years (44.8% mild, 53.0% moderate, 51.9% severe vs. 37.7% non-CLD; p < 0.001). New York Heart Association functional class improved in more than 80% of patients with CLD at 1 and 3 years. All patients had a nearly 20-point improvement in KCCQ-OS at 1 and 3 years. However, only 43.3% of patients with CLD had a favorable health benefit at 1 year and 22.5% at 3 years. CONCLUSIONS: Moderate and severe CLD increases 1- and 3-year mortality after TAVR. Although functional status and quality of life were improved in CLD at 1 and 3 years after TAVR, a favorable health benefit was only achieved in selected patients. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Perioperative Management of Dual-Antiplatelet Therapy in Patients With New-Generation Drug-Eluting Metallic Stents and Bioresorbable Vascular Scaffolds Undergoing Elective Noncardiac Surgery.

Dual-antiplatelet therapy (DAPT) is considered mandatory after new-generation drug-eluting coronary stent implantation to reduce ischemic complications such as stent thrombosis, but the need for DAPT makes the timing of elective surgery difficult. Interrupting DAPT places patients at risk for stent thrombosis, and surgery in the setting of DAPT may lead to bleeding. The 2016 American College of Cardiology/American Heart Association guideline recommends delaying elective noncardiac surgery for a minimum 6-month period to reduce ischemic risks after the implantation of a second-generation metallic drug-eluting stent (DES). However, the guideline fails to appropriately stratify surgical patients based on the indication for second-generation metallic DES implantation and other patient characteristics. The Absorb bioresorbable vascular scaffold (Abbott Vascular, Abbott Park, IL), which has a higher propensity for stent thrombosis compared with second-generation metallic DES, also produces DAPT management challenges in patients presenting for elective noncardiac surgery. Due to the novelty of bioresorbable vascular scaffold therapy, there are no guidelines available for the management of patients undergoing elective noncardiac surgery. This review addresses DAPT management in patients undergoing noncardiac surgery less than 12 months after new-generation metallic DES or bioresorbable vascular scaffold implantation and provides further guidance for anesthesiologists who encounter these challenging cases.

Vascular Assessment for Transcatheter Aortic Valve Replacement: Intravascular Ultrasound Compared With Computed Tomography.

BACKGROUND: Assessment of the femoral and iliac arteries is essential prior to transcatheter aortic valve replacement (TAVR). It is critical for establishing candidacy for a femoral approach, and can help predict vascular complications. Although computed tomography angiography (CTA) is the standard imaging modality, it has limitations. OBJECTIVE: This study compared CTA with intravascular ultrasound (IVUS) in patients undergoing TAVR evaluation. METHODS: Fifteen patients undergoing pre-TAVR coronary angiography and hemodynamic assessment were recruited. Following coronary angiography, patients underwent distal aortography, bilateral iliac and femoral arteriography, and IVUS assessment. Vascular tortuosity, minimum lumen diameter, and cross-sectional area were obtained and the findings were compared with those obtained from CTA. RESULTS: Correlation between IVUS and CTA was strong for minimum luminal diameter (r=0.62). Concordance was also strong between CTA and invasive iliofemoral angiography for assessment of tortuosity (r=0.75). Utilizing Bland-Altman analysis, vessel diameters obtained by IVUS were consistently greater than those obtained by CTA. The angiography and IVUS strategy was associated with a lower overall mean contrast utilization (29 cc vs 100 cc; P<.001), reduced mean radiation exposure (527 mGy vs 998 mGy; P=.045), and no significant difference in mean test duration (13.3 minutes vs 10 minutes; P=.12). CONCLUSIONS: For femoral and iliac arterial assessment prior to TAVR, IVUS is a viable alternative to CTA with comparable accuracy, and the potential for less contrast use and less radiation exposure. IVUS is also a valuable adjunct to CTA in patients with borderline femoral access diameters or considerable CTA artifacts.

Final results of the ReoPro readministration registry.

Because of its potential for antigenicity, theoretical concerns related to readministration of abciximab have been raised. We conducted the ReoPro Readministration Registry to assess the efficacy and safety of abciximab readministration. A total of 1,342 patients who underwent percutaneous coronary intervention and who received abciximab for at least a second time were recruited. Safety end points were hypersensitivity reactions, major bleeding, and thrombocytopenia (TCP). Human antichimeric antibody (HACA) titers were determined before and after readministration. Procedural success was 98% and was not influenced by the number of courses of abciximab or the presence of HACA. There were no cases of anaphylaxis. There were 5 minor allergic reactions, none of which required termination of the infusion. Clinically significant bleeding occurred in 31 patients (2.3%), including 1 (0.07%) with intracranial hemorrhage. TCP (<100 x 10(9)/L) developed in 5% of patients; profound TCP (<20 x 10(9)/L) occurred in 2%. In patients who received abciximab within 1 month of a previous treatment (n = 115), the risk of developing TCP and profound TCP was 16.5% and 12.2%, respectively. Having a positive HACA before readministration was not correlated with adverse clinical outcomes or bleeding, but was associated with TCP (14.1% vs 4.4%, p = 0.002) and profound TCP (5.6% vs 1.6%, p = 0.036). Readministration of abciximab can be accomplished without severe allergic responses and with a bleeding and efficacy profile similar to first-time administration. However, the rate of severe and profound TCP is increased relative to first-time administration, particularly when the time between treatments is <30 days or when HACA is present.

Cutting balloon angioplasty of the popliteal and infrapopliteal vessels for symptomatic limb ischemia.

Options for lower limb percutaneous revascularization are limited especially for complex vessel obstruction. Cutting balloon angioplasty (CBA) has been described in the coronary literature as effective for complex disease. We analyzed our peripheral vascular database and report procedural outcomes along with the clinical success at a mean of 1-year follow-up in 73 patients with symptomatic lower limb ischemia undergoing CBA. CBA was successfully completed in all 73 patients (93 vessels; 100%) with predilation necessary in 4% of vessels. Severe intimal dissection or inadequate hemodynamic result necessitated in adjunctive stenting in 20%. There were no incidents of vessel perforation or surgical target vessel revascularization. One patient (1.5%) died during the periprocedural period due to renal failure. After mean follow-up of 1 year (6-21 months), 89.5% of threatened limbs were salvaged. CBA is a safe and feasible option for the treatment of popliteal and infrapopliteal vessels.

The clinical and fiscal impact of endovascular repair of abdominal aortic aneurysms.

PURPOSE: This study analyzed cost, reimbursement, application, and outcome differences between endovascular (ER) and open repair (OR) of abdominal aortic aneurysms (AAA) in a community hospital. METHOD: A total of 187 consecutive elective AAA repairs by both methods (69 ER, 118 OR) performed at a single center between July 2001 and March 2003 were analyzed. Average values in postoperative clinical and fiscal demographics were calculated for this period. RESULTS: The average length of stay was higher for OR than ER (9.38 days versus 1.94 days, P < .001). Significant reductions in operative time (4 hours versus 2.67 hours) and intensive care unit use (100% versus 4.05%) were seen in the ER population. Total hospital costs were slightly higher for OR than ER (21,989 dollars versus 19,668 dollars) despite a considerable difference in cost of the grafts (>11,000 dollars for ER versus <500 dollars for OR). However, hospital charges were much lower for ER than OR (32,660 dollars versus 48,877 dollars), and there was an average loss of 4986 dollars on ER cases versus a profit of 2064 dollars on OR procedures. Thirty-day mortality was not significantly improved in the ER population (1.45% versus 2.54%, P = .05). CONCLUSIONS: Our data suggest that ER offers improvements in hospital convalescence and operating room times but no improvements in fiscal impact or overall morbidity/ mortality rates when similar preoperative medical risks exist.

Challenges associated with the integration of endovascular repair of abdominal aortic aneurysms in a community hospital.

PURPOSE: There has been considerable debate regarding the proper place for endovascular repair (ER) of abdominal aortic aneurysms (AAAs) versus traditional open repair (OR). Our study compared preoperative patient demographics and outcomes for elective, asymptomatic AAA repairs performed at our center over a 33-month period. METHODS: For this study, we selected 342 consecutive elective infrarenal AAA repairs performed between July 1, 2000, and March 31, 2003, at Riverside Methodist Hospital. The patients underwent either ER or OR, depending on patient and surgeon collaborative determinations. Ruptured and symptomatic AAAs were excluded from our study. Preoperative demographics, anesthesia, complications, and discharge status for the 2 groups were analyzed, and statistical analysis was done to determine statistically significant differences. RESULTS: The preoperative status of the ER and OR patient groups were essentially similar. There were only 3 significant differences between the 2 groups: alcohol use was higher for the OR group than for the ER group (12.0% versus 5.2%; P = .04), and the incidence of type II diabetes mellitus and peripheral vascular disease were lower for the OR group compared with the ER group (6.7% versus 13.4% [P = .04] and 18.3% versus 30.6% [P = .008], respectively). The OR group used more general anesthesia than the ER group (99% versus 86%; P < .001) and had more complications, including dysrhythmia (8.65% versus 1.59%; P = .005), ileus (13.94% versus 0.79%; P < .0001), infection (8.17% versus 0.0%; P = .0007), respiratory complications (12.50% versus 1.59%; P = .0003), and renal complications (5.29% versus 0.79%; P = .032). The ER group had a higher rate of wound hematoma (4.76% versus 0.48%; P = .007). ER patients also had significantly less blood loss (379 mL versus 1930 mL; P < .001), a better independent discharge status (P < .0001), a shorter length of stay (1.8 days versus 8.2 days; P < .001), and a lower mortality rate (0.75% versus 3.85%; P = .0954). CONCLUSIONS: From our study we cautiously continue to encourage the consideration of the ER of AAAs in our patient population while being mindful of its limitations.

Oblique groin incision for endovascular repair of abdominal aortic aneurysms.

PURPOSE: Groin incision for access to the femoral artery is necessary for stent graft repair of abdominal aortic aneurysm (AAA). However, lymphatic and infectious complications can occur during wound healing after surgery. A vertical incision traditionally is used, but a new oblique incision technique has the potential to reduce complications. We report our results from AAA stent repairs performed via oblique incisions at our center for a 33-month period. METHODS: Data for 134 consecutive patients undergoing elective stent repair of asymptomatic infrarenal AAA performed by 2 cardiovascular surgeons at a single center from July 1, 2000, to March 31, 2003, were gathered for analysis. Wound complication percentages for infections, paresthesias, sepsis, and seroma were calculated. RESULTS: In 134 patients, a total of 278 incisions were made. Reasons for extra incisions included improving catheter entry angle (5 cases), tunneling for vascular tapes (3 cases), and initial approach too low (2 cases). The percentages were, however, calculated on a per-patient basis. Thirty day analysis revealed a 0% infection rate, 4.7% incidence of paresthesias, 2.38% rate of wound seroma, and 0% wound sepsis rate. CONCLUSION: Because of the nonexistent infection rate and low wound complication rate, our data supports the use of oblique groin incisions for stent repair of asymptomatic infrarenal AAA.

Use of glycoprotein IIb/IIIa platelet inhibitors in peripheral vascular interventions.

With the expanding use of endovascular techniques for the treatment of peripheral vascular disease, consideration of glycoprotein IIb/IIIa receptor inhibitors to enhance the safety and efficacy of these procedures has increased. The scientific literature shows the benefits with the use of these agents in coronary vasculature interventions. However, data evaluating treatment with glycoprotein IIb/IIIa receptor inhibitors during peripheral vascular procedures is limited, with the vast majority of the trials investigating abciximab. With the varied vascular beds and end organs that may be affected by peripheral vascular intervention, the safety and efficacy may need to be studies for each area. The current literature ranging from carotid stenting to thrombolysis and mechanical thrombectomy for acute limb ischemia is reviewed, and recommendations are discussed on the use of these agents. The forthcoming results of controlled clinical trials should further clarify the clinical applications of these agents in peripheral vascular intervention.

Rheolytic thrombectomy in the management of limb ischemia: 30-day results from a multicenter registry.

PURPOSE: To evaluate the use of rheolytic thrombectomy (RT) with the AngioJet catheter for treatment of lower extremity ischemia due to arterial/graft thrombotic occlusion. METHODS: A retrospective multicenter review was performed of 99 consecutive patients (52 men; mean age 67 +/- 13 years, range 30-90) who underwent RT for thrombotic occlusions in native arteries (n=80) or bypass grafts (n=19). Pre- and postprocedural limb ischemia and in-hospital events were evaluated. Amputation and mortality rates at 30 days were determined. RESULTS: The majority of patients (78.8%) presented within 14 days of symptom onset. RT resulted in substantial to complete thrombus removal in 70 (70.7%) patients and partial in 22 (22.2%); there was no angiographic change in 7 (7.1%). Adjunctive post RT thrombolysis was used in 37 patients. Underlying stenoses found in 81 limbs were treated with one or more of the following procedures: balloon angioplasty (n=62), stenting (n=35), or nonemergent surgical revision (n=5). In-hospital complications included 2 major amputations, 5 cases of minor tissue loss, 7 rethromboses, and 3 cases of transient renal insufficiency. Four (4.0% patients died in-hospital; the 95 surviving patients all had viable limbs at discharge. Mortality and amputation rates at 30 days were 7.1% and 4.0%, respectively. CONCLUSIONS: Percutaneous treatment of thrombotic occlusions with RT, followed by definitive treatment of the underlying stenosis, is a promising therapeutic option for patients with limb-threatening ischemia.

Clinical results for the training-phase roll-in patients in the Intracoil femoralpopliteal stent trial.

The purpose of this study was to report the results of the roll-in patients for the multicenter IntraCoil trial in the femoropopliteal arteries at 9-month follow-up. Ninety-three roll-in patients (mean age, 67.8 +/- 10.5 years; 62.4% male gender) constituted the learning phase for the 22 clinical sites. Obstructive femoropopliteal artery disease up to 15 cm was treated with stenting. Clinical patency was measured over a 9-month period by clinical and hemodynamic data as well as the Rutherford scale. Diabetes mellitus was present in 35.5%. Twenty-nine percent of lesions treated were occlusions. The mean reference diameter for treated lesions was 4.27 +/- 1.11 mm, while the mean lesion length was 3.83 +/- 3.69 cm. Acute angiographic success by operator evaluation was obtained in 98.9% of patients. Major complications occurred in 3.2%. No patient experienced abrupt or subacute closure. There were two reports of failure to deliver assigned stent. In both incidences, the stent was removed without surgical intervention. There were also three reports of stent misplacement (moving during delivery), one report of stent migration, one report of delivery system failure. At 30-day and 9-month follow-up of successfully treated patients, 100%/77.9% remained free of major adverse clinical events (MACE) and 100%/81.8% target lesion revascularization (TLR), respectively. At 9-month follow-up, ankle-brachial index increased from 0.66 +/- 0.22 to 0.83 +/- 0.20 while mean maximum walking time increased form 4.47 +/- 3.02 to 5.91 +/- 3.97 min. The use of the IntraCoil stent appears to have a short learning curve. Excellent clinical and hemodynamic patency is seen at 9 months. The randomized comparison trial comparing the IntraCoil to angioplasty is pending.

Randomized trial of a distal embolic protection device during percutaneous intervention of saphenous vein aorto-coronary bypass grafts.

BACKGROUND: Stents provide effective treatment for stenotic saphenous venous aorto-coronary bypass grafts, but their placement carries a 20% incidence of procedure-related complications, which potentially are related to the distal embolization of atherosclerotic debris. We report the first multicenter randomized trial to evaluate use of a distal embolic protection device during stenting of such lesions. METHODS AND RESULTS: Of 801 eligible patients, 406 were randomly assigned to stent placement over the shaft of the distal protection device, and 395 were assigned to stent placement over a conventional 0.014-inch angioplasty guidewire (control group). The primary end point-a composite of death, myocardial infarction, emergency bypass, or target lesion revascularization by 30 days-was observed in 65 patients (16.5%) assigned to the control group and 39 patients (9.6%) assigned to the embolic protection device (P=0.004). This 42% relative reduction in major adverse cardiac events was driven by myocardial infarction (8.6% versus 14.7%, P=0.008) and "no-reflow" phenomenon (3% versus 9%, P=0.02). Clinical benefit was seen even when platelet glycoprotein IIb/IIIa receptor blockers were administered (61% of patients), with composite end points occurring in 10.7% of protection device patients versus 19.4% of control patients (P=0.008). CONCLUSIONS: Use of this distal protection device during stenting of stenotic venous grafts was associated with a highly significant reduction in major adverse events compared with stenting over a conventional angioplasty guidewire. This demonstrates the importance of distal embolization in causing major adverse cardiac events and the value of embolic protection devices in preventing such complications.

Infrapopliteal Endovascular Techniques: Indications, Techniques, and Results.

The emerging field of endovascular therapy is opening up new therapeutic avenues for the treatment of peripheral vascular disease. The infrapopliteal arterial bed is a complex vascular bed. Treatment is usually restricted to patients with limb-threatening ischemia. Although education and medical therapy play a cornerstone role in long-term success, endovascular therapy offers a potentially easy low-risk treatment for early healing of damaged tissue. Surgical therapy remains the gold standard of treatment, but there remains significant associated morbidity and mortality. A clear understanding of the vascular anatomy, disease process, extent of tissue damage and comorbidities is necessary in forming the treatment plan for any particular patient. Close follow-up and possible retreatment is a key responsibility for the endovascular physician.