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Samir R. Kapadia - One of the best experts on this subject based on the ideXlab platform.

  • Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Risk.
    Circulation, 2019
    Co-Authors: Suzanne J Baron, John A. House, Elizabeth A. Magnuson, Raj Makkar, Vinod H. Thourani, Howard C. Herrmann, Matthew R. Reynolds, Susheel Kodali, Kaijun Wang, Samir R. Kapadia
    Abstract:

    Background: In patients with severe Aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter Aortic Valve Replacement (TAVR) or surgical Aortic Valve Replacement (SAVR) resu...

  • protection against cerebral embolism during transcatheter Aortic Valve Replacement
    Journal of the American College of Cardiology, 2017
    Co-Authors: Samir R. Kapadia, Raj Makkar, Susheel Kodali, Roxana Mehran, Ronald M Lazar, Robert Zivadinov, Michael G Dwyer, Hasan Jilaihawi, Renu Virmani, Saif Anwaruddin
    Abstract:

    AbstractBackground: Neurological complications after transcatheter Aortic Valve Replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP).Objectives: This study evalua...

  • protection against cerebral embolism during transcatheter Aortic Valve Replacement
    Journal of the American College of Cardiology, 2017
    Co-Authors: Samir R. Kapadia, Raj Makkar, Susheel Kodali, Roxana Mehran, Ronald M Lazar, Robert Zivadinov, Michael G Dwyer, Hasan Jilaihawi, Renu Virmani, Saif Anwaruddin
    Abstract:

    Abstract Background Neurological complications after transcatheter Aortic Valve Replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP). Objectives This study evaluated the safety and efficacy of TCEP during TAVR. Methods Nineteen centers randomized 363 patients undergoing TAVR to a safety arm (n = 123), device imaging (n = 121), and control imaging (n = 119). The primary safety endpoint consisted of major adverse cardiac and cerebrovascular events (MACCE) at 30 days, and the primary efficacy endpoint was reduction in new lesion volume in protected brain territories on magnetic resonance imaging scans at 2 to 7 days. Patients underwent neurocognitive assessments, and the debris captured was analyzed. Results The rate of MACCE (7.3%) was noninferior to the performance goal (18.3%, pnoninferior  Conclusions TCEP was safe, captured embolic debris in 99% of patients, and did not change neurocognitive function. Reduction in new lesion volume on magnetic resonance scans was not statistically significant. (Cerebral Protection in Transcatheter Aortic Valve Replacement [SENTINEL]; NCT02214277)

  • characterization and outcome of patients with severe symptomatic Aortic stenosis referred for percutaneous Aortic Valve Replacement
    The Journal of Thoracic and Cardiovascular Surgery, 2009
    Co-Authors: Samir R. Kapadia, Lars G Svensson, Eric E Roselli, Paul Schoenhagen, Srikanth Sola, Sachin S Goel, Robert M Savage, Lee Wallace, Mehdi H Shishehbor, Ryan D Christofferson
    Abstract:

    Objective Many high-risk patients with severe symptomatic Aortic stenosis are not referred for surgical Aortic Valve Replacement. Although this patient population remains ill-defined, many of these patients are now being referred for percutaneous Aortic Valve Replacement. We sought to define the characteristics and outcomes of patients referred for percutaneous Aortic Valve Replacement. Methods Between February 2006 and March 2007, 92 patients were screened for percutaneous Aortic Valve Replacement. Clinical and echocardiographic characteristics of patients undergoing surgical Aortic Valve Replacement, percutaneous Aortic Valve Replacement, balloon Aortic valvuloplasty, or no intervention were compared. The primary end point was all-cause mortality. Results Nineteen patients underwent successful surgical Aortic Valve Replacement, 18 patients underwent percutaneous Aortic Valve Replacement, and 36 patients had no intervention. Thirty patients underwent balloon Aortic valvuloplasty, and of these, 8 patients were bridged to percutaneous Aortic Valve Replacement and 3 were bridged to surgical Aortic Valve Replacement. Of the remaining 19 patients undergoing balloon Aortic valvuloplasty, bridging to percutaneous Aortic Valve Replacement could not be accomplished because of death (n = 9 [47%)], exclusion from the percutaneous Aortic Valve Replacement protocol (n = 6 [32%]), and some patients improved after balloon Aortic valvuloplasty and declined percutaneous Aortic Valve Replacement (n = 4 [21%]). The most common reasons for no intervention included death while awaiting definitive treatment (n = 10 [28%]), patient uninterested in percutaneous Aortic Valve Replacement (n = 10 [28%]), and questionable severity of symptoms or Aortic stenosis (n = 9 [25%]). Patients not undergoing Aortic Valve Replacement had higher mortality compared with those undergoing Aortic Valve Replacement (44% vs 14%) over a mean duration of 220 days. Conclusion Symptomatic patients with severe Aortic stenosis have high mortality if timely Aortic Valve Replacement is not feasible. Twenty percent of the patients referred for percutaneous Aortic Valve Replacement underwent surgical Aortic Valve Replacement with good outcome. Patients undergoing balloon Aortic valvuloplasty alone or no intervention had unfavorable outcomes.

  • Aortic root morphology in patients undergoing percutaneous Aortic Valve Replacement evidence of Aortic root remodeling
    The Journal of Thoracic and Cardiovascular Surgery, 2009
    Co-Authors: Mateen Akhtar, Samir R. Kapadia, Murat E Tuzcu, Lars G Svensson, Roy K Greenberg, Eric E Roselli, Sandra S Halliburton, Vikram Kurra, Paul Schoenhagen, Srikanth Sola
    Abstract:

    Objective Percutaneous Aortic Valve Replacement is an emerging therapy for selected patients with severe Aortic stenosis. Preoperative imaging of the Aortic root facilitates sizing and deployment of the percutaneous Aortic Valve Replacement device. We compared morphologic characteristics of the Aortic root in patients with Aortic stenosis versus elderly gender-matched controls using multidetector computed tomography. Methods Twenty-five consecutive subjects with severe calcific Aortic stenosis referred for percutaneous Aortic Valve Replacement and 25 elderly gender-matched controls were scanned on a Siemens Definition Dual Source (Siemens Medical, Forchheim, Germany) multidetector computed tomography scanner. Distances from the Valve annulus to the coronary artery ostia and sinotubular junction, dimensions of the Aortic root, and characteristics of the Valve cusps were determined. Results Subjects with Aortic stenosis had reduced distance from the Aortic Valve annulus to the inferior margins of the left and right coronary artery ostium and sinotubular junction compared with controls. There were no significant differences in cross-sectional dimensions of the Aortic root. Conclusion The distance from the Aortic Valve annulus to the coronary artery ostia and sinotubular junction is reduced in patients with Aortic stenosis compared with controls. This finding suggests that longitudinal remodeling of the Aortic root occurs in calcific Aortic stenosis and has implications for the design and deployment of percutaneous Aortic Valve Replacement devices.

Lars G Svensson - One of the best experts on this subject based on the ideXlab platform.

  • five year outcomes of transcatheter or surgical Aortic Valve Replacement
    The New England Journal of Medicine, 2020
    Co-Authors: Raj Makkar, Vinod H. Thourani, Susheel Kodali, Michael J Mack, Lars G Svensson, Samir Kapadia, John G Webb, Sunghan Yoon, Alfredo Trento, Howard C. Herrmann
    Abstract:

    Abstract Background There are scant data on long-term clinical outcomes and bioprosthetic-Valve function after transcatheter Aortic-Valve Replacement (TAVR) as compared with surgical Aortic-Valve r...

  • transcatheter or surgical Aortic Valve Replacement in intermediate risk patients
    The New England Journal of Medicine, 2016
    Co-Authors: Martin B Leon, Vinod H. Thourani, Susheel Kodali, Michael J Mack, Lars G Svensson, Craig R Smith, Rajendra Makkar, Murat Tuzcu, Craig D Miller
    Abstract:

    BackgroundPrevious trials have shown that among high-risk patients with Aortic stenosis, survival rates are similar with transcatheter Aortic-Valve Replacement (TAVR) and surgical Aortic-Valve Replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients. MethodsWe randomly assigned 2032 intermediate-risk patients with severe Aortic stenosis, at 57 centers, to undergo either TAVR or surgical Replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical Replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. ResultsThe rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan–Meier event...

  • characterization and outcome of patients with severe symptomatic Aortic stenosis referred for percutaneous Aortic Valve Replacement
    The Journal of Thoracic and Cardiovascular Surgery, 2009
    Co-Authors: Samir R. Kapadia, Lars G Svensson, Eric E Roselli, Paul Schoenhagen, Srikanth Sola, Sachin S Goel, Robert M Savage, Lee Wallace, Mehdi H Shishehbor, Ryan D Christofferson
    Abstract:

    Objective Many high-risk patients with severe symptomatic Aortic stenosis are not referred for surgical Aortic Valve Replacement. Although this patient population remains ill-defined, many of these patients are now being referred for percutaneous Aortic Valve Replacement. We sought to define the characteristics and outcomes of patients referred for percutaneous Aortic Valve Replacement. Methods Between February 2006 and March 2007, 92 patients were screened for percutaneous Aortic Valve Replacement. Clinical and echocardiographic characteristics of patients undergoing surgical Aortic Valve Replacement, percutaneous Aortic Valve Replacement, balloon Aortic valvuloplasty, or no intervention were compared. The primary end point was all-cause mortality. Results Nineteen patients underwent successful surgical Aortic Valve Replacement, 18 patients underwent percutaneous Aortic Valve Replacement, and 36 patients had no intervention. Thirty patients underwent balloon Aortic valvuloplasty, and of these, 8 patients were bridged to percutaneous Aortic Valve Replacement and 3 were bridged to surgical Aortic Valve Replacement. Of the remaining 19 patients undergoing balloon Aortic valvuloplasty, bridging to percutaneous Aortic Valve Replacement could not be accomplished because of death (n = 9 [47%)], exclusion from the percutaneous Aortic Valve Replacement protocol (n = 6 [32%]), and some patients improved after balloon Aortic valvuloplasty and declined percutaneous Aortic Valve Replacement (n = 4 [21%]). The most common reasons for no intervention included death while awaiting definitive treatment (n = 10 [28%]), patient uninterested in percutaneous Aortic Valve Replacement (n = 10 [28%]), and questionable severity of symptoms or Aortic stenosis (n = 9 [25%]). Patients not undergoing Aortic Valve Replacement had higher mortality compared with those undergoing Aortic Valve Replacement (44% vs 14%) over a mean duration of 220 days. Conclusion Symptomatic patients with severe Aortic stenosis have high mortality if timely Aortic Valve Replacement is not feasible. Twenty percent of the patients referred for percutaneous Aortic Valve Replacement underwent surgical Aortic Valve Replacement with good outcome. Patients undergoing balloon Aortic valvuloplasty alone or no intervention had unfavorable outcomes.

  • Aortic root morphology in patients undergoing percutaneous Aortic Valve Replacement evidence of Aortic root remodeling
    The Journal of Thoracic and Cardiovascular Surgery, 2009
    Co-Authors: Mateen Akhtar, Samir R. Kapadia, Murat E Tuzcu, Lars G Svensson, Roy K Greenberg, Eric E Roselli, Sandra S Halliburton, Vikram Kurra, Paul Schoenhagen, Srikanth Sola
    Abstract:

    Objective Percutaneous Aortic Valve Replacement is an emerging therapy for selected patients with severe Aortic stenosis. Preoperative imaging of the Aortic root facilitates sizing and deployment of the percutaneous Aortic Valve Replacement device. We compared morphologic characteristics of the Aortic root in patients with Aortic stenosis versus elderly gender-matched controls using multidetector computed tomography. Methods Twenty-five consecutive subjects with severe calcific Aortic stenosis referred for percutaneous Aortic Valve Replacement and 25 elderly gender-matched controls were scanned on a Siemens Definition Dual Source (Siemens Medical, Forchheim, Germany) multidetector computed tomography scanner. Distances from the Valve annulus to the coronary artery ostia and sinotubular junction, dimensions of the Aortic root, and characteristics of the Valve cusps were determined. Results Subjects with Aortic stenosis had reduced distance from the Aortic Valve annulus to the inferior margins of the left and right coronary artery ostium and sinotubular junction compared with controls. There were no significant differences in cross-sectional dimensions of the Aortic root. Conclusion The distance from the Aortic Valve annulus to the coronary artery ostia and sinotubular junction is reduced in patients with Aortic stenosis compared with controls. This finding suggests that longitudinal remodeling of the Aortic root occurs in calcific Aortic stenosis and has implications for the design and deployment of percutaneous Aortic Valve Replacement devices.

Vinod H. Thourani - One of the best experts on this subject based on the ideXlab platform.

  • sts acc tvt registry of transcatheter Aortic Valve Replacement
    The Annals of Thoracic Surgery, 2021
    Co-Authors: John D Carroll, Vinod H. Thourani, Howard C. Herrmann, Michael G Deeb, Thomas G Gleason, Michael J Mack, Sreekanth Vemulapalli, George S Hanzel, David J Cohen, Nimesh D Desai
    Abstract:

    The STS-ACC TVT Registry (Society of Thoracic Surgeons-American College of Cardiology Transcatheter Valve Therapy Registry) from 2011 to 2019 has collected data on 276,316 patients undergoing transcatheter Aortic Valve Replacement (TAVR) at sites in all U.S. states. Volumes have increased every year, exceeding surgical Aortic Valve Replacement in 2019 (72,991 vs. 57,626), and it is now performed in all U.S. states. TAVR now extends from extreme- to low-risk patients. This is the first presentation on 8,395 low-risk patients treated in 2019. In 2019, for the entire cohort, femoral access increased to 95.3%, hospital stay was 2 days, and 90.3% were discharged home. Since 2011, the 30-day mortality rate has decreased (7.2% to 2.5%), stroke has started to decrease (2.75% to 2.3%), but pacemaker need is unchanged (10.9% to 10.8%). Alive with acceptable patient-reported outcomes is achieved in 8 of 10 patients at 1 year. The Registry is a national resource to improve care and analyze TAVR's evolution. Real-world outcomes, site performance, and the impact of coronavirus disease 2019 will be subsequently studied. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528).

  • five year outcomes of transcatheter or surgical Aortic Valve Replacement
    The New England Journal of Medicine, 2020
    Co-Authors: Raj Makkar, Vinod H. Thourani, Susheel Kodali, Michael J Mack, Lars G Svensson, Samir Kapadia, John G Webb, Sunghan Yoon, Alfredo Trento, Howard C. Herrmann
    Abstract:

    Abstract Background There are scant data on long-term clinical outcomes and bioprosthetic-Valve function after transcatheter Aortic-Valve Replacement (TAVR) as compared with surgical Aortic-Valve r...

  • prognostic implications of discharge patterns after transcatheter Aortic Valve Replacement
    Journal of the American College of Cardiology, 2019
    Co-Authors: Satya Shreenivas, Vinod H. Thourani, Susheel Kodali, Martin B Leon, Scott Lilly, Michael J Mack, David Cohen, Suzanne V Arnold, Yiran Zhang, Dean J Kereiakes
    Abstract:

    The prognostic value of discharge patterns after transcatheter Aortic Valve Replacement (TAVR) has not been established. We aimed to determine if pre-procedure variables predict discharge patterns and if discharge to a medical facility portends increased mortality. Study population included TAVR

  • procedural volume and outcomes for transcatheter Aortic Valve Replacement
    The New England Journal of Medicine, 2019
    Co-Authors: Sreekanth Vemulapalli, Vinod H. Thourani, Michael J Mack, John D Carroll, David Dai, Andrzej S Kosinski, Dharam J Kumbhani, Carlos E Ruiz, George S Hanzel, Thomas G Gleason
    Abstract:

    Abstract Background During the introduction of transcatheter Aortic-Valve Replacement (TAVR) in the United States, requirements regarding procedural volume were mandated by the Centers for Medicare...

  • Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Risk.
    Circulation, 2019
    Co-Authors: Suzanne J Baron, John A. House, Elizabeth A. Magnuson, Raj Makkar, Vinod H. Thourani, Howard C. Herrmann, Matthew R. Reynolds, Susheel Kodali, Kaijun Wang, Samir R. Kapadia
    Abstract:

    Background: In patients with severe Aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter Aortic Valve Replacement (TAVR) or surgical Aortic Valve Replacement (SAVR) resu...

Eric E Roselli - One of the best experts on this subject based on the ideXlab platform.

  • should less invasive Aortic Valve Replacement be avoided in patients with pulmonary dysfunction
    The Journal of Thoracic and Cardiovascular Surgery, 2014
    Co-Authors: Turki B Albacker, Marc A Gillinov, Eric E Roselli, Eugene H Blackstone, Sarah J Williams, Jose L Navia, Suresh Keshavamurthy, Gosta B Pettersson, Tomislav Mihaljevic, Douglas R Johnston
    Abstract:

    Objective In patients with pulmonary dysfunction, it is unclear whether a less-invasive approach for Aortic Valve Replacement is well tolerated or even beneficial. We investigated whether a partial upper J-incision for Aortic Valve Replacement leads to more favorable outcomes than a full sternotomy in patients with chronic lung disease by using forced expiratory volume in 1 second as a surrogate. Methods From January 1995 to July 2010, 6931 patients underwent primary isolated Aortic Valve Replacement; 655 had forced expiratory volume in 1 second measured and expressed as percent of predicted (FEV1%; 368 via J-incision, 287 via full sternotomy). Postoperative outcomes were compared among 223 propensity-matched pairs. Results Patients diagnosed with chronic lung disease had longer median intensive care unit (41 vs 27 hours, P  = .001) and postoperative (7.1 vs 6.1 days, P P  = .07) was possibly higher in matched patients with J-incision, but late survival was similar ( P  = .9). Patients with FEV1% less than 50 who underwent J-incision had the greatest survival advantage, which persisted for 5 years. Conclusions In patients with preoperative respiratory dysfunction, a less-invasive partial upper J-incision for Aortic Valve Replacement can lead to more favorable outcomes than a full sternotomy, including shorter intensive care unit and postoperative lengths of stay and better early survival, which are amplified with decreasing pulmonary function.

  • characterization and outcome of patients with severe symptomatic Aortic stenosis referred for percutaneous Aortic Valve Replacement
    The Journal of Thoracic and Cardiovascular Surgery, 2009
    Co-Authors: Samir R. Kapadia, Lars G Svensson, Eric E Roselli, Paul Schoenhagen, Srikanth Sola, Sachin S Goel, Robert M Savage, Lee Wallace, Mehdi H Shishehbor, Ryan D Christofferson
    Abstract:

    Objective Many high-risk patients with severe symptomatic Aortic stenosis are not referred for surgical Aortic Valve Replacement. Although this patient population remains ill-defined, many of these patients are now being referred for percutaneous Aortic Valve Replacement. We sought to define the characteristics and outcomes of patients referred for percutaneous Aortic Valve Replacement. Methods Between February 2006 and March 2007, 92 patients were screened for percutaneous Aortic Valve Replacement. Clinical and echocardiographic characteristics of patients undergoing surgical Aortic Valve Replacement, percutaneous Aortic Valve Replacement, balloon Aortic valvuloplasty, or no intervention were compared. The primary end point was all-cause mortality. Results Nineteen patients underwent successful surgical Aortic Valve Replacement, 18 patients underwent percutaneous Aortic Valve Replacement, and 36 patients had no intervention. Thirty patients underwent balloon Aortic valvuloplasty, and of these, 8 patients were bridged to percutaneous Aortic Valve Replacement and 3 were bridged to surgical Aortic Valve Replacement. Of the remaining 19 patients undergoing balloon Aortic valvuloplasty, bridging to percutaneous Aortic Valve Replacement could not be accomplished because of death (n = 9 [47%)], exclusion from the percutaneous Aortic Valve Replacement protocol (n = 6 [32%]), and some patients improved after balloon Aortic valvuloplasty and declined percutaneous Aortic Valve Replacement (n = 4 [21%]). The most common reasons for no intervention included death while awaiting definitive treatment (n = 10 [28%]), patient uninterested in percutaneous Aortic Valve Replacement (n = 10 [28%]), and questionable severity of symptoms or Aortic stenosis (n = 9 [25%]). Patients not undergoing Aortic Valve Replacement had higher mortality compared with those undergoing Aortic Valve Replacement (44% vs 14%) over a mean duration of 220 days. Conclusion Symptomatic patients with severe Aortic stenosis have high mortality if timely Aortic Valve Replacement is not feasible. Twenty percent of the patients referred for percutaneous Aortic Valve Replacement underwent surgical Aortic Valve Replacement with good outcome. Patients undergoing balloon Aortic valvuloplasty alone or no intervention had unfavorable outcomes.

  • Aortic root morphology in patients undergoing percutaneous Aortic Valve Replacement evidence of Aortic root remodeling
    The Journal of Thoracic and Cardiovascular Surgery, 2009
    Co-Authors: Mateen Akhtar, Samir R. Kapadia, Murat E Tuzcu, Lars G Svensson, Roy K Greenberg, Eric E Roselli, Sandra S Halliburton, Vikram Kurra, Paul Schoenhagen, Srikanth Sola
    Abstract:

    Objective Percutaneous Aortic Valve Replacement is an emerging therapy for selected patients with severe Aortic stenosis. Preoperative imaging of the Aortic root facilitates sizing and deployment of the percutaneous Aortic Valve Replacement device. We compared morphologic characteristics of the Aortic root in patients with Aortic stenosis versus elderly gender-matched controls using multidetector computed tomography. Methods Twenty-five consecutive subjects with severe calcific Aortic stenosis referred for percutaneous Aortic Valve Replacement and 25 elderly gender-matched controls were scanned on a Siemens Definition Dual Source (Siemens Medical, Forchheim, Germany) multidetector computed tomography scanner. Distances from the Valve annulus to the coronary artery ostia and sinotubular junction, dimensions of the Aortic root, and characteristics of the Valve cusps were determined. Results Subjects with Aortic stenosis had reduced distance from the Aortic Valve annulus to the inferior margins of the left and right coronary artery ostium and sinotubular junction compared with controls. There were no significant differences in cross-sectional dimensions of the Aortic root. Conclusion The distance from the Aortic Valve annulus to the coronary artery ostia and sinotubular junction is reduced in patients with Aortic stenosis compared with controls. This finding suggests that longitudinal remodeling of the Aortic root occurs in calcific Aortic stenosis and has implications for the design and deployment of percutaneous Aortic Valve Replacement devices.

Susheel Kodali - One of the best experts on this subject based on the ideXlab platform.

  • five year outcomes of transcatheter or surgical Aortic Valve Replacement
    The New England Journal of Medicine, 2020
    Co-Authors: Raj Makkar, Vinod H. Thourani, Susheel Kodali, Michael J Mack, Lars G Svensson, Samir Kapadia, John G Webb, Sunghan Yoon, Alfredo Trento, Howard C. Herrmann
    Abstract:

    Abstract Background There are scant data on long-term clinical outcomes and bioprosthetic-Valve function after transcatheter Aortic-Valve Replacement (TAVR) as compared with surgical Aortic-Valve r...

  • prognostic implications of discharge patterns after transcatheter Aortic Valve Replacement
    Journal of the American College of Cardiology, 2019
    Co-Authors: Satya Shreenivas, Vinod H. Thourani, Susheel Kodali, Martin B Leon, Scott Lilly, Michael J Mack, David Cohen, Suzanne V Arnold, Yiran Zhang, Dean J Kereiakes
    Abstract:

    The prognostic value of discharge patterns after transcatheter Aortic Valve Replacement (TAVR) has not been established. We aimed to determine if pre-procedure variables predict discharge patterns and if discharge to a medical facility portends increased mortality. Study population included TAVR

  • Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Risk.
    Circulation, 2019
    Co-Authors: Suzanne J Baron, John A. House, Elizabeth A. Magnuson, Raj Makkar, Vinod H. Thourani, Howard C. Herrmann, Matthew R. Reynolds, Susheel Kodali, Kaijun Wang, Samir R. Kapadia
    Abstract:

    Background: In patients with severe Aortic stenosis (AS) at intermediate surgical risk, treatment with transcatheter Aortic Valve Replacement (TAVR) or surgical Aortic Valve Replacement (SAVR) resu...

  • protection against cerebral embolism during transcatheter Aortic Valve Replacement
    Journal of the American College of Cardiology, 2017
    Co-Authors: Samir R. Kapadia, Raj Makkar, Susheel Kodali, Roxana Mehran, Ronald M Lazar, Robert Zivadinov, Michael G Dwyer, Hasan Jilaihawi, Renu Virmani, Saif Anwaruddin
    Abstract:

    AbstractBackground: Neurological complications after transcatheter Aortic Valve Replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP).Objectives: This study evalua...

  • protection against cerebral embolism during transcatheter Aortic Valve Replacement
    Journal of the American College of Cardiology, 2017
    Co-Authors: Samir R. Kapadia, Raj Makkar, Susheel Kodali, Roxana Mehran, Ronald M Lazar, Robert Zivadinov, Michael G Dwyer, Hasan Jilaihawi, Renu Virmani, Saif Anwaruddin
    Abstract:

    Abstract Background Neurological complications after transcatheter Aortic Valve Replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP). Objectives This study evaluated the safety and efficacy of TCEP during TAVR. Methods Nineteen centers randomized 363 patients undergoing TAVR to a safety arm (n = 123), device imaging (n = 121), and control imaging (n = 119). The primary safety endpoint consisted of major adverse cardiac and cerebrovascular events (MACCE) at 30 days, and the primary efficacy endpoint was reduction in new lesion volume in protected brain territories on magnetic resonance imaging scans at 2 to 7 days. Patients underwent neurocognitive assessments, and the debris captured was analyzed. Results The rate of MACCE (7.3%) was noninferior to the performance goal (18.3%, pnoninferior  Conclusions TCEP was safe, captured embolic debris in 99% of patients, and did not change neurocognitive function. Reduction in new lesion volume on magnetic resonance scans was not statistically significant. (Cerebral Protection in Transcatheter Aortic Valve Replacement [SENTINEL]; NCT02214277)