A Special Clinical Scenario for Transcatheter Aortic Valve Replacement: "Iatrogenic Double-Outlet" Left Ventricle.

A 67-year-old man with a history of chest radiotherapy and severe aortic valve stenosis with calcification of the ascending aortic wall underwent implantation of an apicoaortic conduit from the left ventricular apex to the descending aorta. Eight years later, he presented with progressive exertional dyspnea. Imaging revealed severe native aortic valve insufficiency and calcification, with worsening left ventricular function. We decided to leave the apicoaortic conduit intact and perform transcatheter aortic valve replacement with a balloon-expandable prosthesis. Despite concerns that eliminating the obstruction across the native left ventricular outflow tract might decrease conduit flow and eventually cause graft thrombosis and peripheral embolization, we elected to move forward after a multidisciplinary discussion. The procedure resulted in angiographically and qualitatively similar forward flow across the newly implanted prosthesis and the existing apicoaortic conduit, with no hemodynamic or electrical dysfunction. The patient was discharged from the hospital the next day. At the 1-month follow-up visit, the patient felt well and reported marked functional improvement, with minimal symptoms during moderate to heavy exertion. The stroke volume index across the new bioprosthetic valve was low (13 mL/m2 at 1 mo and 18 mL/m2 at 1 y), suggesting that a substantial amount of blood was still exiting the ventricle through the left ventricle-to-aorta conduit. This report offers some guidance for treating patients with existing apicoaortic conduits and suggests that transcatheter aortic valve replacement is safe and effective if native aortic valve insufficiency develops.

Long-term results of carotid stenting versus endarterectomy in high-risk patients.

BACKGROUND: We previously reported that, in a randomized trial, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy for the treatment of carotid artery disease at 30 days and at 1 year. We now report the 3-year results. METHODS: The trial evaluated carotid artery stenting with the use of an emboli-protection device as compared with endarterectomy in 334 patients at increased risk for complications from endarterectomy who had either a symptomatic carotid artery stenosis of at least 50% of the luminal diameter or an asymptomatic stenosis of at least 80%. The prespecified major secondary end point at 3 years was a composite of death, stroke, or myocardial infarction within 30 days after the procedure or death or ipsilateral stroke between 31 days and 1080 days (3 years). RESULTS: At 3 years, data were available for 260 patients (77.8%), including 85.6% of patients in the stenting group and 70.1% of those in the endarterectomy group. The prespecified major secondary end point occurred in 41 patients in the stenting group (cumulative incidence, 24.6%; Kaplan-Meier estimate, 26.2%) and 45 patients in the endarterectomy group (cumulative incidence, 26.9%; Kaplan-Meier estimate, 30.3%) (absolute difference in cumulative incidence for the stenting group, -2.3%; 95% confidence interval, -11.8 to 7.0). There were 15 strokes in each of the two groups, of which 11 in the stenting group and 9 in the endarterectomy group were ipsilateral. CONCLUSIONS: In our trial of patients with severe carotid artery stenosis and increased surgical risk, no significant difference could be shown in long-term outcomes between patients who underwent carotid artery stenting with an emboli-protection device and those who underwent endarterectomy. (ClinicalTrials.gov number, NCT00231270 [ClinicalTrials.gov].).

"Simple" Transcatheter Aortic Valve Replacement With Conscious Sedation: Safety and Effectiveness in Real-World Practice.

Transcatheter aortic valve replacement (TAVR) is a well-established alternative to open surgical replacement. Strictly selecting low-risk patients and using conscious sedation during TAVR has enabled hospital stays to be safely shortened. We evaluated the safety and effectiveness of a less rigorous patient-selection process involving multidisciplinary case discussions, percutaneous procedures with the use of conscious sedation, and postprocedural care outside an intensive care unit, with the goal of discharging patients from the hospital early. We call this "simple TAVR." We retrospectively reviewed the records of patients who underwent TAVR from March 2015 through February 2020 at our center. The procedures were performed by 2 high-volume operators. Of 524 total procedures, 344 (65.6%) qualified as simple TAVR. All 344 procedures were successful. The highest 30-day complication rate was associated with new permanent pacemaker implantation (7.3%, 25 patients); the rates of major vascular complications, stroke, and all-cause death were less than 3% each. Of note, 252 patients (73.3%) were discharged from the hospital the day after TAVR, and 307 (89.2%) within 48 hours. Simple TAVR is safe, economical, and feasible in real-world practice, and it does not necessitate a rigorous perioperative protocol or patient-selection process.

Transcatheter aortic valve replacement after chest radiation: A propensity-matched analysis.

BACKGROUND: Chest radiation therapy (CRT) for malignant thoracic neoplasms is associated with development of valvular heart disease years later. As previous radiation exposure can complicate surgical treatment, transcatheter aortic valve replacement (TAVR) has emerged as an alternative. However, outcomes data are lacking for TAVR patients with a history of CRT. METHODS: We conducted a retrospective study of all patients who underwent a TAVR procedure at a single institution between September 2012 and November 2018. Among 1341 total patients, 50 had previous CRT. These were propensity-matched in a 1:2 ratio to 100 patients without history of CRT. Thirty-day adverse events were analyzed with generalized estimating equation models. Overall mortality was analyzed with stratified Cox regression modelling. RESULTS: Median clinical follow-up was 24 months (interquartile range [IQR], 12-44 months). There was no difference between CRT and non-CRT patients in overall mortality (hazard ratio [HR] 0.84 [0.37-1.90], P = 0.67), 30-day mortality (HR 3.1 [0.49-20.03], P = 0.23), or 30-day readmission rate (HR 1.0 [0.43-2.31], P = 1). There were no differences in the rates of most adverse events, but patients with CRT history had higher rates of postprocedural respiratory failure (HR 3.63 [1.32-10.02], P = 0.01) and permanent pacemaker implantation (HR 2.84 [1.15-7.01], P = 0.02). CONCLUSIONS: For patients with aortic valve stenosis and previous CRT, TAVR is safe and effective, with outcomes similar to those in the general aortic stenosis population. Patients with history of CRT are more likely to have postprocedural respiratory failure and to require permanent pacemaker implantation.

Hemodynamic outcomes after valve-in-valve transcatheter aortic valve replacement: a single-center experience.

BACKGROUND: Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) has emerged as a safe, effective alternative to redo aortic valve surgery in high-risk patients with degenerated surgical bioprosthetic valves. However, ViV-TAVR has been associated high postprocedural valvular gradients, compared with TAVR for native-valve aortic stenosis. METHODS: We performed a retrospective study of all patients who underwent ViV-TAVR for a degenerated aortic valve bioprosthesis between January 1, 2013 and March 31, 2019 at our center. The primary outcome was postprocedural mean aortic valve gradient. Outcomes were compared across surgical valve type (stented versus stentless), surgical valve internal diameter (≤19 versus >19 mm), and transcatheter aortic valve type (self-expanding vs. balloon-expandable). RESULTS: Overall, 89 patients underwent ViV-TAVR. Mean age was 69.0±12.6 years, 61% were male, and median Society of Thoracic Surgeons Predicted Risk of Mortality score was 5.4 [interquartile range, 3.2-8.5]. Bioprosthesis mode of failure was stenotic (58% of patients), regurgitant (24%), or mixed (18%). The surgical valve was stented in 75% of patients and stentless in 25%. The surgical valve's internal diameter was ≤19 mm in 45% of cases. A balloon-expandable transcatheter valve was used in 53% of procedures. Baseline aortic valve area and mean gradients were 0.87±0.31 cm2 and 36±18 mmHg, respectively. These improved after ViV-TAVR to 1.38±0.55 cm2 and 18±11 mmHg at a median outpatient follow-up of 331 [67-394] days. Higher postprocedural mean gradients were associated with surgical valves having an internal diameter ≤19 mm (24±13 versus 16±8, P=0.002) and with stented surgical valves (22±11 versus 12±6, P<0.001). CONCLUSIONS: ViV-TAVR is an effective option for treating degenerated surgical aortic bioprostheses, with acceptable hemodynamic outcomes. Small surgical valves and stented surgical valves are associated with higher postprocedural gradients.

Protected carotid-artery stenting versus endarterectomy in high-risk patients.

BACKGROUND: Carotid endarterectomy is more effective than medical management in the prevention of stroke in patients with severe symptomatic or asymptomatic atherosclerotic carotid-artery stenosis. Stenting with the use of an emboli-protection device is a less invasive revascularization strategy than endarterectomy in carotid-artery disease. METHODS: We conducted a randomized trial comparing carotid-artery stenting with the use of an emboli-protection device to endarterectomy in 334 patients with coexisting conditions that potentially increased the risk posed by endarterectomy and who had either a symptomatic carotid-artery stenosis of at least 50 percent of the luminal diameter or an asymptomatic stenosis of at least 80 percent. The primary end point of the study was the cumulative incidence of a major cardiovascular event at 1 year--a composite of death, stroke, or myocardial infarction within 30 days after the intervention or death or ipsilateral stroke between 31 days and 1 year. The study was designed to test the hypothesis that the less invasive strategy, stenting, was not inferior to endarterectomy. RESULTS: The primary end point occurred in 20 patients randomly assigned to undergo carotid-artery stenting with an emboli-protection device (cumulative incidence, 12.2 percent) and in 32 patients randomly assigned to undergo endarterectomy (cumulative incidence, 20.1 percent; absolute difference, -7.9 percentage points; 95 percent confidence interval, -16.4 to 0.7 percentage points; P=0.004 for noninferiority, and P=0.053 for superiority). At one year, carotid revascularization was repeated in fewer patients who had received stents than in those who had undergone endarterectomy (cumulative incidence, 0.6 percent vs. 4.3 percent; P=0.04). CONCLUSIONS: Among patients with severe carotid-artery stenosis and coexisting conditions, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy.

Endovascular repair of paraanastomotic aneurysms after aortic reconstruction.

We designed this retrospective study to evaluate the effectiveness of percutaneous approaches for repair of paraanastomotic aneurysms that develop after surgical aortic reconstruction. The catheterization records of patients who had undergone percutaneous repair of para-anastomotic aneurysms from January 2001 through December 2005 were reviewed, and data regarding preoperative aneurysm size, risk factors, intraoperative techniques, morbidity, and death were recorded. Eight patients had undergone exclusion of a total of 10 paraanastomotic aneurysms. The average age of the prosthetic graft at diagnosis was 11.7 years. Four of the patients were symptomatic; none of these had a ruptured aneurysm. All patients received commercially available devices. Technical success was achieved in all patients. Conscious sedation alone was administered to 7 patients. There were no in-hospital deaths, and morbidity was minimal. We conclude that endovascular exclusion of paraanastomotic aneurysms after aortic reconstruction is a viable alternative to open surgical repair and greatly reduces the risk of morbidity and death.

Endovascular repair of a ruptured descending thoracic aortic aneurysm.

Endovascular aneurysm repair has considerable potential advantages over the surgical approach as a treatment for thoracic aortic rupture, in part because open surgical repair of ruptured thoracic aortic aneurysms is associated with high mortality and morbidity rates. We describe the successful endovascular deployment of stent-grafts to repair a contained rupture of a descending thoracic aortic aneurysm in an 86-year-old man whose comorbidities prohibited surgery. Two months after the procedure, magnetic resonance angiography showed a patent stent-graft, a patent left subclavian artery, and complete exclusion of the aneurysm.

Endovascular Treatment of Superior Vena Cava Syndrome via Balloon-in-Balloon Catheter Technique with a Palmaz Stent.

Superior vena cava syndrome is a well-known disease entity that carries substantial rates of morbidity and mortality. Although most cases of superior vena cava syndrome are secondary to a malignant process, additional causes (such as mediastinal fibrosis, pacemaker lead implantation, or central venous catheter placement) have been reported. Multiple treatment options include percutaneous transluminal angioplasty, stent implantation, thrombolysis, mechanical thrombectomy, and venous grafting. We present a case of superior vena cava syndrome in a symptomatic 30-year-old woman who obtained complete relief of obstruction and marked symptomatic improvement through venoplasty and stenting, aided by our use of a balloon-in-balloon catheter system.

Anomalous origin of the right coronary artery from the left coronary sinus: case report and literature review.

A 41-year-old man with no relevant cardiac history presented for evaluation of episodic syncope. Electrocardiography showed sinus rhythm with right bundle-branch block and Q waves in leads II, III, and aVF. Subsequent exercise treadmill testing and technetium 99m sestamibi study revealed a reversible posterior defect. Coronary angiography later showed a right coronary artery that arose from the left coronary sinus--an anomaly that has been associated with angina, myocardial infarction, and sudden cardiac death. After being informed of the potential risks and options associated with this anomaly, the patient chose long-term beta-blocker medical therapy. At follow-up, this treatment appeared to have resolved his episodic syncope.

Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II).

OBJECTIVES: The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial evaluated the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for stent placement. BACKGROUND: Despite advances in interventional techniques, treatment of calcified coronary lesions remains a challenge. Stent placement in these lesions may result in stent underexpansion, malapposition, and procedural complications. METHODS: ORBIT II is a prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions at 49 U.S. sites from May 25, 2010, to November 26, 2012. Investigators used the centrifugal action of the OAS diamond-coated crown to modify calcified lesions prior to stent placement. RESULTS: The pre-procedure mean minimal lumen diameter of 0.5 mm increased to 2.9 mm after the procedure. The primary safety endpoint was 89.6% freedom from 30-day major adverse cardiac events compared with the performance goal of 83%. The primary efficacy endpoint (residual stenosis <50% post-stent without in-hospital major adverse cardiac events) was 88.9% compared with the performance goal of 82%. Stent delivery occurred successfully in 97.7% of cases with <50% stenosis in 98.6% of subjects. Low rates of in-hospital Q-wave myocardial infarction (0.7%), cardiac death (0.2%), and target vessel revascularization (0.7%) were reported. CONCLUSIONS: The ORBIT II coronary OAS trial met both the primary safety and efficacy endpoints by significant margins. Preparation of severely calcified plaque with the OAS not only helped facilitate stent delivery, but improved both acute and 30-day clinical outcomes compared with the outcomes of historic control subjects in this difficult-to-treat patient population. (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions [ORBIT II]; NCT01092416).

Spontaneous celiac artery dissection case report and literature review.

Symptomatic spontaneous celiac artery dissection is a rare condition that is being detected more often with the use of advanced imaging techniques. There is no consensus as to whether surgical or endovascular treatment is more appropriate.We describe the case of a 41-year-old hypertensive woman who presented with the sudden onset of sharp, persistent, right-upper-quadrant abdominal and epigastric pain. Magnetic resonance angiography of the abdomen revealed celiac artery dissection, with a flap compressing the lumen approximately 17 mm from the artery's origin at the aorta. Because of the patient's persistent epigastric pain, endovascular celiac artery stent implantation was performed with the use of 2 overlapping balloon-expandable stents. Twelve months after the procedure, the patient remained asymptomatic, and the stents were patent. This case and others in the medical literature suggest that endovascular treatment can be feasible in symptomatic patients with isolated spontaneous celiac artery dissection.

Fistula from right internal mammary artery to superior vena cava after use of a laser sheath to extract a pacemaker lead.

A 55-year-old woman presented with dyspnea on exertion due to a right internal mammary artery-to-superior vena cava arteriovenous fistula that occurred after pacemaker lead extraction with a laser sheath. The fistula was successfully repaired by placing a covered stent in the right internal mammary artery. In this unusual location, endovascular stenting is a reasonable alternative to coil embolization or surgical repair of an arteriovenous fistula resulting from laser lead extraction.

Low-permeability Gore Excluder device versus the original in abdominal aortic aneurysm size regression.

We sought to compare the efficacy of a low-permeability version of the Gore Excluder™ device with that of the original device. We used volumetric analysis and maximum transverse diameter measurements to examine abdominal aortic aneurysm size regression after endovascular aneurysm repair.From November 2002 through April 2007, 101 patients (82% men; mean age, 71.5 ± 8.9 yr) underwent endovascular aneurysm repair with the Excluder stent-graft: 34 with the original device, and 67 with the low-permeability device. Only patients without endoleak and with preprocedural and 1- and 2-year follow-up computed tomographic scans were included. Eight patients with type II endoleak and 2 with type I endoleak were excluded. Maximum abdominal aortic aneurysm diameter and volume were measured before endovascular aneurysm repair and annually thereafter. Postprocessing, multiplanar computed tomography, and 3-dimensional reconstructions were compared with baseline measurements. Diameter and volume changes that were greater than 5 mm or that exceeded 10% were considered significant.At 12 months, the mean maximum transverse diameter had decreased by -0.16 ± 12.1 mm in recipients of the original device and by -4.8 ± 5.9 mm in recipients of the low-permeability device (P = NS). In addition, mean reduction in volume had changed by -17 ± 16 mL in original-device recipients and by -36.1 ± 37.9 mL in low-permeability device recipients (P < 0.01).One-year follow-up revealed that the low-permeability stent-graft resulted in a greater decrease in abdominal aortic aneurysm volume than did the original stent-graft.

Benefits of catheter thrombectomy during carotid stenting: a preliminary study.

Despite the use of distal embolic protection devices (DEPs) in carotid artery (CA) stenting, an appreciable risk of stroke exists, particularly in symptomatic patients. The mechanism of embolic events is possibly related to microembolization of atherothrombotic débris that remains or forms on the stent struts. This study evaluated the safety of using thrombus-extraction catheters in the setting of CA stenting.From August 2006 through June 2008, 43 symptomatic and asymptomatic patients with severe CA stenosis (>90%) underwent CA stenting with DEPs. After stenting and before removal of the DEP, an extraction catheter was passed through the stented segment. The extracted volume and the filtered extracted volume were visually examined for débris. The primary outcome was a composite of stroke and death at 30 days. Outcomes were compared with those in a control population of 783 patients who underwent CA stenting with a DEP, but without prophylactic thrombus aspiration. Retrospective analysis was performed on prospectively gathered data.Substantial amounts of atherothrombotic débris were extracted from the stented segment in all 43 thrombectomy patients, none of whom died or experienced periprocedural stroke. In the control group, 3.9% of patients experienced these outcomes. Differences in primary outcome did not reach statistical significance.We conclude that the prophylactic use of extraction catheters is safe and does not incur periprocedural events. The results of this preliminary study are encouraging, although larger, randomized trials (optimally using diffusion-weighted magnetic resonance imaging) are needed in order to evaluate this technique's potential benefits in reducing neurologic complications.

Endovascular exclusion of popliteal artery aneurysms with stent-grafts: a prospective single-center experience.

PURPOSE: To determine the safety and efficacy of percutaneous treatment for popliteal artery aneurysms (PAA) using self-expanding stent-grafts. METHODS: From October 2000 through September 2007, 29 patients (27 men; mean age 68+/-6 years, range 54-88) underwent endovascular exclusion of 33 PAAs. All had symptoms of claudication, and all were atherosclerotic in origin. Four patients presented with popliteal venous thrombosis. Twenty-eight of the treated PAAs had associated mural thrombus. The mean aneurysm diameter was 34.3+/-13.3 mm and the mean lesion length was 98.6+/-102.1 mm. RESULTS: All PAAs were successfully excluded from the arterial circulation using 59 stent-grafts (15 Wallgraft and 44 Viabahn). The average number of stent-grafts implanted was 1.9+/-0.4 (range 1-3); the mean length of covered vessel (per lesion) was 198.6+/-105.3 mm. There were no device-associated complications or deaths. Over an average follow-up of 35.4+/-32.1 months (range 6-120), the primary and secondary patency rates, respectively, were 93.9% and 100% at 6 months, 93.9% and 96.9% at 1 year, and 87.5% and 96.8% at 2 years. At 4.5 years, primary and secondary patency rates were 84.8% and 96.8%, respectively. No endoleaks, aneurysm rupture, thromboembolism, or limb loss occurred at follow-up. CONCLUSION: Stent-graft exclusion of PAAs is safe and effective, yielding primary and secondary patency rates comparable to surgical repair. In spite of encouraging results in this study, further larger studies are warranted to reconfirm our observations.

Predictors of carotid stent restenosis.

OBJECTIVES: We sought to determine the predictors of restenosis after carotid artery stenting and report alternatives for its management. BACKGROUND: Carotid artery stenting has been increasingly accepted as an alternative to carotid endarterectomy (CEA). Predictors of carotid stent restenosis have not been firmly established, and management of restenotic lesions can be challenging. METHODS: A retrospective, single-center review was conducted of 399 carotid stent procedures in 363 patients over 9 years, with a mean follow-up of 24 months (range 6-99 months). Clinical variables included age, gender, symptoms, hypertension, diabetes, tobacco use, renal insufficiency, coronary artery disease, hyperlipidemia, peripheral vascular disease, history of CEA, and history of neck radiation (XRT). Angiographic variables included reference vessel diameter, lesion length, post-stenting residual stenosis, stent diameter, type of stent, and number of stents. RESULTS: Overall, restenosis occurred in 15 patients (3.8%). However, the restenosis occurred in 7 of 35 (20%) patients who had previous XRT, 6 of 57 (10.5%) patients who had previous CEA, and 2 of 9 (22%) patients who previously had both CEA and XRT. The only analyzed variables that were significantly associated with an increased risk of restenosis were previous CEA (OR 4.28, P = 0.008) or XRT (OR 11.3, P

Stent deployment for peripheral venous stenosis as a result of radiation therapy.

Arterial occlusive disease is a well-known complication of radiation therapy, but venous thrombosis and occlusion after radiotherapy may also occur. We report the use of an endovascular stent to treat a patient who developed peripheral venous stenosis 4 years after radiation therapy for malignant melanoma.