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Article ; Online: The history of proximal carotid protection and flow reversal to prevent stent angioplasty embolization.

Parodi, Juan / Bates, Mark C / Ohki, Takao / Schönholz, Claudio

2018 Volume 31, Issue 1, Page(s) 9–14

Abstract: Innovation in medicine is often driven by the observations of imaginative physicians who are blessed with insatiable curiosity, coupled with the inability to accept technical boundaries, the status quo of patient care, or the acceptance of procedural ... ...

Abstract	Innovation in medicine is often driven by the observations of imaginative physicians who are blessed with insatiable curiosity, coupled with the inability to accept technical boundaries, the status quo of patient care, or the acceptance of procedural morbidity. Few examples illustrate this truism better than the physician-originated clinical research that transformed the safety of carotid stent angioplasty over the last 2 decades. Initial clinical application of carotid stenting suggested that proximal protection may be a better approach to prevent embolic stroke during the angioplasty procedure. The history of how this innovation was developed is particularly relevant as vascular surgeons adopt new endovascular therapies. It has been more than 15 years since Dr Juan Parodi put together a multidisciplinary team of scientists and clinicians to test the "proximal protection" hypothesis. The goal of this overview was to provide Dr Parodi team's perspective on the development of the proximal protection and flow reversal concept to minimize plaque embolization during carotid stent angioplasty procedures.
MeSH term(s)	Angioplasty/adverse effects ; Angioplasty/instrumentation ; Angioplasty/trends ; Carotid Artery Diseases/complications ; Carotid Artery Diseases/diagnostic imaging ; Carotid Artery Diseases/physiopathology ; Carotid Artery Diseases/therapy ; Cerebrovascular Circulation ; Diffusion of Innovation ; Embolic Protection Devices/trends ; Humans ; Intracranial Embolism/diagnostic imaging ; Intracranial Embolism/etiology ; Intracranial Embolism/physiopathology ; Intracranial Embolism/prevention & control ; Prosthesis Design ; Protective Factors ; Regional Blood Flow ; Risk Factors ; Stents/trends ; Stroke/diagnostic imaging ; Stroke/etiology ; Stroke/physiopathology ; Stroke/prevention & control ; Treatment Outcome
Language	English
Publishing date	2018-03-07
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	645131-7
ISSN	1558-4518 ; 0895-7967
ISSN (online)	1558-4518
ISSN	0895-7967
DOI	10.1053/j.semvascsurg.2018.03.002
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Article ; Online: Advantages to Indigo mechanical thrombectomy for ALI: device and technique.

Yamada, R / Adams, J / Guimaraes, M / Schönholz, C

The Journal of cardiovascular surgery

2015 Volume 56, Issue 3, Page(s) 393–400

Abstract: Catheter-directed thrombolysis (CDT) has been used as the first therapeutic option for acute limb ischemia (ALI) due to its less invasive nature; however, recent systematic review showed higher incidence of major complications related to lytic infusion, ... ...

Abstract	Catheter-directed thrombolysis (CDT) has been used as the first therapeutic option for acute limb ischemia (ALI) due to its less invasive nature; however, recent systematic review showed higher incidence of major complications related to lytic infusion, including hemorrhagic stroke. In this setting, aspiration thrombectomy with Indigo has the greatest advantage of not increasing systemic risk of bleeding. The Indigo™ system from Penumbra® (Alameda, CA, USA) promotes active thrombectomy using a vacuum pump that generates substantial suction, enabling aspiration of clots of varying sizes and lengths. The device has three components: aspiration catheter, separator and pump. There are 2 aspiration catheter sizes: CAT 3 and CAT 5. The separators are intended to mobilize the clot and clean the catheter lumen, and therefore restoring flow for continuous aspiration. The pump is small-sized equipment capable of applying near pure vacuum aspiration pressure of -29 mmHg. Aspiration thrombectomy with Indigo has two key advantages: it does not require the use of lytics, and it provides immediate flow reestablishment. Its use when thrombolysis is contraindicated or has failed is already well established and, in the future, it may likely become the first line endovascular option in patients with acute limb ischemia.
MeSH term(s)	Acute Disease ; Equipment Design ; Humans ; Ischemia/diagnosis ; Ischemia/physiopathology ; Ischemia/therapy ; Lower Extremity/blood supply ; Mechanical Thrombolysis/adverse effects ; Mechanical Thrombolysis/instrumentation ; Mechanical Thrombolysis/methods ; Suction ; Thrombectomy/adverse effects ; Thrombectomy/instrumentation ; Thrombectomy/methods ; Treatment Outcome ; Vascular Access Devices ; Vascular Patency
Language	English
Publishing date	2015-06
Publishing country	Italy
Document type	Journal Article
ZDB-ID	80143-4
ISSN	1827-191X ; 0021-9509
ISSN (online)	1827-191X
ISSN	0021-9509
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Article ; Online: New technologies for CAS that might overcome the burden of microembolization.

Yamada, R / Guimaraes, M / Adams, J / Schönholz, C

The Journal of cardiovascular surgery

2015 Volume 56, Issue 6, Page(s) 859–865

Abstract: Microembolization during carotid artery stenting (CAS) is the result of embolic events shown by intraprocedural transcranial Doppler (TCD) or postprocedure diffusion-weighted MRI that do not lead to acute neurological deficit. Although the long term ... ...

Abstract	Microembolization during carotid artery stenting (CAS) is the result of embolic events shown by intraprocedural transcranial Doppler (TCD) or postprocedure diffusion-weighted MRI that do not lead to acute neurological deficit. Although the long term clinical outcome of these silent infarcts is not yet well established, there is increasing evidence that these events could be associated with neurological impairments, such as cognitive decline. In order to prevent microembolization due to excessive catheter manipulation at the time of guiding catheter placement in patients with challenging anatomy, a cervical access system with flow reversal protection was developed. Other embolic events are often seen as the result of plaque protrusion through stent struts. A new type of stent, so-called "hybrid" stent, incorporates the flexibility and conformability of an open-cell stent as well as plaque coverage seen with a close-cell stent, with the goal of achieving better plaque stabilization reducing macro and microembolization, while maintaining original vessel anatomy and flow hemodynamic. At the present time there are three different stents under investigation or this application.
MeSH term(s)	Angioplasty/adverse effects ; Angioplasty/instrumentation ; Angioplasty/mortality ; Brain Ischemia/diagnosis ; Brain Ischemia/etiology ; Brain Ischemia/mortality ; Brain Ischemia/physiopathology ; Brain Ischemia/prevention & control ; Carotid Artery Diseases/complications ; Carotid Artery Diseases/diagnosis ; Carotid Artery Diseases/mortality ; Carotid Artery Diseases/physiopathology ; Carotid Artery Diseases/therapy ; Cerebrovascular Circulation ; Embolic Protection Devices ; Hemodynamics ; Humans ; Intracranial Embolism/diagnosis ; Intracranial Embolism/etiology ; Intracranial Embolism/mortality ; Intracranial Embolism/physiopathology ; Intracranial Embolism/prevention & control ; Prosthesis Design ; Risk Factors ; Stents ; Treatment Outcome ; Vascular Access Devices
Language	English
Publishing date	2015-12
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	80143-4
ISSN	1827-191X ; 0021-9509
ISSN (online)	1827-191X
ISSN	0021-9509
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Article ; Online: History of Proximal Carotid Protection and Flow Reversal.

Parodi, Juan / Bates, Mark C / Ohki, Takao / Schönholz, Claudio

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

2017 Volume 24, Issue 2, Page(s) 271–274

MeSH term(s)	Arteries ; Carotid Stenosis ; Embolic Protection Devices ; Humans ; Treatment Outcome
Language	English
Publishing date	2017-03-23
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	2006618-1
ISSN	1545-1550 ; 1526-6028
ISSN (online)	1545-1550
ISSN	1526-6028
DOI	10.1177/1526602817693601
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Article ; Online: Early endovascular grafts at Montefiore Hospital and their effect on vascular surgery.

Veith, Frank J / Cynamon, Jacob / Schonholz, Claudio J / Parodi, Juan C

Journal of vascular surgery

2014 Volume 59, Issue 2, Page(s) 547–550

Abstract: Vascular surgery is very fortunate. It recognized the transition from open surgery to endovascular procedures as treatments for vascular disease early enough to adapt as a specialty. As a result, most vascular surgeons in North America became competent ... ...

Abstract	Vascular surgery is very fortunate. It recognized the transition from open surgery to endovascular procedures as treatments for vascular disease early enough to adapt as a specialty. As a result, most vascular surgeons in North America became competent with endovascular techniques, and the survival of the specialty was assured. The endovascular graft program at Montefiore Hospital played a major role in vascular surgery's early recognition of the importance of the endovascular revolution. This article will review the history of this early endovascular graft program and how it influenced the specialty.
MeSH term(s)	Aortic Aneurysm, Abdominal/history ; Aortic Aneurysm, Abdominal/surgery ; Blood Vessel Prosthesis/history ; Blood Vessel Prosthesis Implantation/history ; Blood Vessel Prosthesis Implantation/instrumentation ; Diffusion of Innovation ; Endovascular Procedures/history ; Endovascular Procedures/instrumentation ; History, 20th Century ; Hospitals/history ; Humans ; New York ; Program Development ; Prosthesis Design/history ; Stents/history ; Treatment Outcome
Language	English
Publishing date	2014-02
Publishing country	United States
Document type	Historical Article ; Journal Article ; Review
ZDB-ID	605700-7
ISSN	1097-6809 ; 0741-5214
ISSN (online)	1097-6809
ISSN	0741-5214
DOI	10.1016/j.jvs.2013.09.051
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Article ; Online: Commentary: Can we provide complete cerebral protection during innominate artery stenting?

Guimaraes, Marcelo / Muhlert, Michael K / Enterkin, Jacob / Schönholz, Claudio

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

2010 Volume 17, Issue 5, Page(s) 657–659

MeSH term(s)	Aged ; Angioplasty, Balloon/adverse effects ; Angioplasty, Balloon/instrumentation ; Arterial Occlusive Diseases/diagnostic imaging ; Arterial Occlusive Diseases/therapy ; Brachiocephalic Trunk/diagnostic imaging ; Cerebrovascular Disorders/etiology ; Cerebrovascular Disorders/prevention & control ; Constriction, Pathologic ; Embolic Protection Devices ; Humans ; Radiography ; Stents ; Treatment Outcome
Language	English
Publishing date	2010-10
Publishing country	United States
Document type	Case Reports ; Journal Article ; Comment
ZDB-ID	2006618-1
ISSN	1545-1550 ; 1526-6028
ISSN (online)	1545-1550
ISSN	1526-6028
DOI	10.1583/10-3156C2.1
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Article ; Online: Minimally Invasive Intact Excision of High-Risk Breast Lesions and Small Breast Cancers: The Intact Percutaneous Excision (IPEX) Registry.

Whitworth, Pat / Schonholz, Steven / Phillips, Rogsbert / Robertson, Yara / Ruiz, Antonio / Winchester, Susan / Graham, Cathy / Simpson, Jean / Wernecke, Chloe

Annals of surgical oncology

2019 Volume 26, Issue 4, Page(s) 954–960

Abstract: Background: Aiming to minimize overtreatment of high-risk breast lesions (HRLs), including atypical ductal hyperplasia, and small breast cancers, including ductal carcinoma in situ (DCIS), we investigated a minimally invasive (MI) approach to definitive ...

Abstract	Background: Aiming to minimize overtreatment of high-risk breast lesions (HRLs), including atypical ductal hyperplasia, and small breast cancers, including ductal carcinoma in situ (DCIS), we investigated a minimally invasive (MI) approach to definitive diagnosis and management of these conditions. Methods: In the prospective Intact Percutaneous Excision registry study, women aged 31-86 years had removal of small invasive cancers, DCIS, or HRLs using image-guided 12-20 mm radiofrequency basket capture (MI excision). Second-pass 20 mm basket capture obtained shaved margins in cancer patients. Standard imaging (specimen, breast) and histologic criteria were applied. Patient data were registered in an Institutional Review Board approved, Health Insurance Portability and Accountability Act-compliant registry. Results: Of 282 registered patients, 124 had DCIS (n = 52) or invasive cancer (n = 72) and 160 had HRLs. Among cancer patients, 101 (81%) had clear histologic margins [average lesion size was 11 mm for both invasive cancers (4-20 mm) and DCIS (1.5-20 mm)]; 29 patients had re-excision (six despite clear margins). Among 160 HRLs, two were upgraded to DCIS and had MI excision. Two other HRL patients had subsequent standard surgical excision (no cancer found). Conclusion: For diminutive HRLs, DCIS, and invasive cancers, MI excision can achieve the same procedure goals as standard surgical excision. Because MI excision removes less tissue with small incisions, it may reduce the discomfort and expense associated with standard treatment.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Biopsy, Needle ; Breast Neoplasms/pathology ; Breast Neoplasms/surgery ; Carcinoma, Ductal, Breast/pathology ; Carcinoma, Ductal, Breast/surgery ; Carcinoma, Intraductal, Noninfiltrating/pathology ; Carcinoma, Intraductal, Noninfiltrating/surgery ; Female ; Follow-Up Studies ; Humans ; Middle Aged ; Minimally Invasive Surgical Procedures/methods ; Prognosis ; Prospective Studies ; Registries/statistics & numerical data
Language	English
Publishing date	2019-02-12
Publishing country	United States
Document type	Journal Article
ZDB-ID	1200469-8
ISSN	1534-4681 ; 1068-9265
ISSN (online)	1534-4681
ISSN	1068-9265
DOI	10.1245/s10434-019-07212-2
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Article ; Online: Evaluation of a novel mesh-covered stent for treatment of carotid stenosis in patients at high risk for endarterectomy: 1-year results of the SCAFFOLD trial.

Gray, William A / Levy, Elad / Bacharach, J Michael / Metzger, David Christopher / Randall, Bryan / Siddiqui, Adnan / Schonholz, Claudio / Alani, Firas / Schneider, Peter A

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

2019 Volume 96, Issue 1, Page(s) 121–127

Abstract: Objective: The SCAFFOLD trial evaluated the GORE® Carotid Stent (GCS), a novel, mesh-covered device and evaluated outcomes at 1 year.: Background: SCAFFOLD was a prospective, multicenter, single-arm clinical trial in patients with severe carotid ... ...

Abstract	Objective: The SCAFFOLD trial evaluated the GORE® Carotid Stent (GCS), a novel, mesh-covered device and evaluated outcomes at 1 year. Background: SCAFFOLD was a prospective, multicenter, single-arm clinical trial in patients with severe carotid artery stenosis (angiographically defined as symptomatic ≥50% or asymptomatic ≥80%) at increased risk for adverse events from carotid endarterectomy. Interim 30-day analysis demonstrated low rates of death/stroke/myocardial infarction (DSMI; 3.0%) and stroke (1.1%) in a high surgical risk population. Methods: The rate of DSMI within 30 days plus ipsilateral stroke between 31 days and 1 year (primary endpoint) was compared to a predetermined performance goal. Secondary outcomes of freedom from clinically driven target lesion revascularization (CD-TLR; diameter stenosis ≥80% by core lab angiography, or ≥50% with clinical symptoms) and restenosis (≥80% diameter stenosis by core lab angiography) are reported as Kaplan-Meier (KM) estimates. Results: Of the 312 patients enrolled and treated, 264 were eligible per protocol and evaluable for major adverse events at 30 days, and 244 (92%) of these were evaluable at 1 year. The proportion of patients with DSMI at 1 year was 4.5% and was significantly lower than the prespecified performance goal of 16.9% (p < .00001). The proportion with ipsilateral stroke from 31 to 365 days was 1.2%. The KM estimates of 1-year event probability were 1.6% for CD-TLR and 1.2% for restenosis. Conclusions: Use of the mesh-covered GCS in the SCAFFOLD trial demonstrated 100% technical success and low rates of both periprocedural and late stroke, with durable patency at 1 year. ClinicalTrials.gov Identifier: NCT01901874 (redacted).
MeSH term(s)	Aged ; Aged, 80 and over ; Carotid Stenosis/complications ; Carotid Stenosis/diagnostic imaging ; Carotid Stenosis/mortality ; Carotid Stenosis/therapy ; Endarterectomy, Carotid/adverse effects ; Endovascular Procedures/adverse effects ; Endovascular Procedures/instrumentation ; Endovascular Procedures/mortality ; Female ; Humans ; Male ; Middle Aged ; Myocardial Infarction/etiology ; Myocardial Infarction/mortality ; Prospective Studies ; Prosthesis Design ; Recurrence ; Risk Assessment ; Risk Factors ; Severity of Illness Index ; Stents ; Stroke/etiology ; Stroke/mortality ; Time Factors ; Treatment Outcome ; United States
Keywords	covid19
Language	English
Publishing date	2019-11-11
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Multicenter Study
ZDB-ID	1459995-8
ISSN	1522-726X ; 1522-1946
ISSN (online)	1522-726X
ISSN	1522-1946
DOI	10.1002/ccd.28586
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Article ; Online: Flow control technique to prevent distal embolization during mechanical thrombectomy.

Wooster, Mathew / Kloda, Daniel / Robison, Jacob / Hart, Joseph / Guimaraes, Marcelo / Todoran, Thomas / Schönholz, Claudio

Journal of vascular surgery

2012 Volume 56, Issue 5, Page(s) 1457–1460

Abstract: In an era of increasing emphasis on minimally invasive surgery, distal embolization remains a concern in the absence of distal flow control. We present a case using an endovascular flow control technique that can be used for reducing distal embolic ... ...

Abstract	In an era of increasing emphasis on minimally invasive surgery, distal embolization remains a concern in the absence of distal flow control. We present a case using an endovascular flow control technique that can be used for reducing distal embolic events during endovascular recanalization of aortoiliac occlusive disease. This technique has been used in four patients so far (two with native anatomy and two with aorto-bi-iliac grafts) with no evidence of angiographic or clinical embolic complications.
MeSH term(s)	Adult ; Embolism/etiology ; Embolism/prevention & control ; Equipment Design ; Female ; Humans ; Regional Blood Flow ; Thrombectomy/adverse effects ; Thrombectomy/instrumentation ; Thrombectomy/methods
Keywords	covid19
Language	English
Publishing date	2012-11
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	605700-7
ISSN	1097-6809 ; 0741-5214
ISSN (online)	1097-6809
ISSN	0741-5214
DOI	10.1016/j.jvs.2012.06.100
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Article: Impact of stent design on the outcome of intervention for carotid bifurcation stenosis.

Hart, J P / Bosiers, M / Deloose, K / Uflacker, R / Schönholz, C J

The Journal of cardiovascular surgery

2010 Volume 51, Issue 6, Page(s) 799–806

Abstract: Over the past several years, there has been continued significant interest in refinement of patient selection, devices, procedures and protocols in an effort to optimize the outcome of percutaneous intervention for carotid bifurcation stenosis, including: ...

Abstract	Over the past several years, there has been continued significant interest in refinement of patient selection, devices, procedures and protocols in an effort to optimize the outcome of percutaneous intervention for carotid bifurcation stenosis, including: ongoing National Institutes of Health and manufacturer trials and registries; the further refinement of existing devices and emergence of new platforms to attain distal embolic protection; ongoing study of what really constitutes a high-risk carotid surgery or stenting patient; and attention to device characteristics and patient-device matching. Within the latter area, considerable interest has focused on stent characteristics that have the potential to impact short and long-term outcome when compared with other stent design strategies when studied in large series. The stent in carotid artery intervention occupies a unique role in that after the embolic protection system has been removed, it is the main line of defense (in concert with aggressive dual antiplatelet therapy) from embolic and thromboembolic complications that may arise from the newly remodeled plaque after post-stent angioplasty. In this review, we aim to update the current status of efforts to relate stent design strategy to outcome in intervention for extracranial carotid artery disease with a focus primarily on the function of "free cell area" (typically lower with closed-cell stents and higher with open-cell stents) in analyses of outcome in carotid artery stenting. Also, the potential role of closed-cell vs. open-cell stent selection in other reports related to carotid artery stenting outcome or complications is reviewed. Rigorous studies have examined the issue of free cell area and arrived at disparate conclusions. Randomized data on the impact of free cell area and cell design strategy on carotid intervention are presently lacking. However, we believe sufficient data and rationale exist 1) to warrant ongoing study of the impact of stent design on outcome in carotid intervention; and 2) to make consideration of closed-cell (low free cell area) stent use a reasonable approach to device selection--when patient factors, lesion characteristics, or device availability make doing so possible.
MeSH term(s)	Angioplasty/adverse effects ; Angioplasty/instrumentation ; Carotid Stenosis/complications ; Carotid Stenosis/diagnostic imaging ; Carotid Stenosis/therapy ; Cerebral Infarction/etiology ; Cerebral Infarction/pathology ; Cerebral Infarction/prevention & control ; Humans ; Magnetic Resonance Imaging ; Patient Selection ; Prosthesis Design ; Radiography ; Risk Assessment ; Severity of Illness Index ; Stents ; Treatment Outcome ; Ultrasonography, Interventional
Language	English
Publishing date	2010-12
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	80143-4
ISSN	1827-191X ; 0021-9509
ISSN (online)	1827-191X
ISSN	0021-9509
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