Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Vascular Closure Device During Percutaneous EVAR and TEVAR Procedures.

Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device in patients undergoing percutaneous endovascular aneurysm repair (PEVAR) or thoracic endovascular aortic repair (TEVAR). Materials and Methods: The SAFE MANTA Study (ClinicalTrials.gov identifier NCT02908880) was a prospective, single-arm, multicenter trial in patients undergoing endovascular interventions using large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or TEVAR) at 20 sites in North America. Patient selection intended to test the MANTA device in populations without morbid obesity, severe calcification, or a severely scarred femoral access area. Of the 263 patients enrolled in the primary analysis cohort, 53 (20.2%) patients (mean age 74.9±8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2) procedures and form the cohort for this subgroup analysis. Per protocol a single MANTA device was deployed in all PEVAR/TEVAR cases. Results: The mean time to hemostasis in the PEVAR/TEVAR cohort was 35±91 seconds, with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA population. The MANTA device met the definition for technical success in 52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE MANTA population. One (1.9%) major complication (access-site stenosis) occurred in this subgroup compared to 14 (5.3%) events in the SAFE population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of the 3 minor pseudoaneurysms was treated with ultrasound-guided compression and the other 2 required no treatment. Conclusion: The MANTA device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous closure devices. Time to hemostasis and complication rates were comparable between the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA device provides reliable closure with a single percutaneous device for PEVAR/TEVAR procedures.

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].).

Determinants and outcomes of asystole during carotid artery stenting.

PURPOSE: To examine the predictors and outcomes of asystole in patients who undergo carotid artery stenting (CAS). METHODS: Forty-three patients (24 men; median age 69 years) with asystole were identified after reviewing the case records of 884 patients who underwent CAS at our institution between 1997 and 2009. The control group comprised 678 patients who underwent stenting in the carotid sinus area without asystole. Univariate and multivariate logistic analyses were used to determine the predictors and outcomes of asystole. RESULTS: A right-sided procedure was more likely to result in asystole [odds ratio (OR) 11.4, 95% CI 4.0 to 32.7, p<0.0001] compared with a left-sided procedure. Patients with a contralateral carotid stenosis (OR 1.7, 95% CI 1.0 to 2.8, p = 0.04) and a left ventricular ejection fraction (LVEF) of <40% (OR 2.2, 95% CI 1.1 to 4.5, p = 0.03) were also more likely to suffer asystole. Smokers appeared less likely to develop asystole (OR 0.25, 95% CI 0.12 to 0.56, p = 0.0006). Periprocedural stroke (14% vs. 1.3%, p<0.001), length of stay during index hospitalization (2.2 vs. 1.2 days, p = 0.002), and 30-day mortality (11.6% vs. 4.1%, p = 0.02) were significantly higher in the asystole group. CONCLUSION: Asystole during CAS is more likely to occur in patients undergoing procedures in the right carotid sinus area, in those who have significant contralateral carotid stenosis, and in those with a reduced LVEF. More caution should be exercised during right-sided than left-sided CAS procedures.

"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.

Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device.

BACKGROUND: Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device. METHODS AND RESULTS: A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%). CONCLUSIONS: In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.

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.

Aorto-Right Ventricular Shunt after TAVR: Rare Complication of Common Procedure.

BACKGROUND: The primary treatment of symptomatic aortic stenosis is aortic valve replacement. Instead of open chest surgery, transcatheter aortic valve replacement (TAVR) is an alternative intervention for high-risk surgical candidates. CLINICAL CASE: A 92-year-old male presented with progressive exertional dyspnea and recurrent syncopal attacks secondary to severe AS. The patient underwent successful transfemoral TAVR with 29 mm Edwards SAPIEN XT valve. His postoperative course was complicated by aorto-right ventricular shunt. The patient's clinical course was followed up for one year. CONCLUSION: This case reports the incidence and clinical course of one of the rare complications of TAVR, aorto-right ventricular fistula. Conservative medical management is appropriate in hemodynamically stable patients with this specific complication.

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.

Cryoplasty for peripheral artery disease in an unselected patient population in a tertiary center.

Endovascular treatment of peripheral artery occlusive disease has suboptimal long-term patency rates. The addition of cryoplasty to balloon angioplasty, which involves the application of cold thermal energy to atherosclerotic plaque, might improve outcomes and decrease the need for reintervention. At a single tertiary center, we retrospectively analyzed data from the angiograms and medical records of unselected patients who underwent cryoplasty for peripheral artery disease from January 2004 through November 2006. We calculated rates of freedom from amputation, freedom from intervention, and freedom from death and examined the data using the Kaplan-Meier method. Paired t tests were used to compare the ankle-brachial indices before and after cryoplasty. The study population comprised 99 patients who received treatment for 132 atherosclerotic lesions, including 62 lesions in the superficial femoral artery, 28 in the popliteal artery, and 25 in arteries below the knee; 71 patients completed follow-up (64 ± 57 wk). Short-term periprocedural success was achieved in 98.5% of the interventions. Dissections occurred in 12.2% of patients treated successfully without bail-out stenting or additional balloon inflations. At 6 months, more than 88% of the patients were alive and had not had an amputation. However, reintervention was required for 42% of patients. Mean ankle-brachial indices improved significantly after treatment (P < 0.0001). Our results show that cryoplasty for treatment of peripheral artery disease is safe and has a high rate of periprocedural success. However, long-term efficacy is compromised because of the frequent need for reintervention.