Acquired Cardiovascular Disease

PARIS – The use of a second-generation zotarolimus-eluting coronary stent rather than a bare metal stent in conjunction with 30 days of dual antiplatelet therapy (DAPT) in patients deemed at high bleeding risk results in lower 1-year rates of major adverse cardiovascular events and stent thrombosis, according to a prespecified analysis of the ZEUS trial presented at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Asked if the ZEUS results mean it’s time to take bare-metal stents (BMS) out of the cupboard and get rid of them, the study presenter, Dr. Marco Valgimigli, replied “I did so already.”

ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates Study) was an open-label, prospective study in which 1,606 patients undergoing urgent or emergent percutaneous coronary intervention were randomized to a thin-strut BMS or the zotarolimus-eluting Endeavor Sprint stent, a second-generation hydrophilic polymer-based device that, uniquely, elutes 100% of the drug within the first 2 weeks. All participants were placed on an intended 30-day regimen of DAPT. The study was conducted in four European countries, explained Dr. Valgimigli of Erasmus University in Rotterdam.

This prespecified analysis focused on the 828 patients with one or more factors placing them at high bleeding risk, since the use of a drug-eluting stent (DES) with a 30-day DAPT protocol hadn’t been adequately studied in that setting, the cardiologist noted.

High bleeding risk was defined by one or more of the following: age greater than 80, being on oral anticoagulation therapy, a prior bleeding event, need for corticosteroid or NSAID therapy, known anemia, or a bleeding diathesis; 47% of study participants had more than one of these criteria.

The primary study endpoint was the composite of all-cause mortality, acute MI, or target vessel revascularization through 1 year of follow-up. The rate was 29% in the BMS group, compared with 22.6% in the DES group, for a highly significant 26% relative risk reduction.

The zotarolimus-eluting stent group also fared significantly better in terms of stent thrombosis and the other prespecified secondary endpoints.

Asked how the ZEUS findings have affected his own clinical practice, Dr. Valgimigli replied, “My stent of choice in patients at high bleeding risk is a second-generation DES. Since there aren’t data showing a specific second-generation DES is preferable, basically whatever I have I implant.”

He sticks to the 30-day DAPT regimen featured in the ZEUS protocol except under specific circumstances, which were allowed under the protocol. One involves staged PCI procedures, in which case the 30 days of DAPT begins after the last stent is implanted, even though the patient has been on DAPT in the interim. The other circumstance where he goes beyond 30 days of DAPT in a patient on a second-generation DES is if an ischemic event occurs down the road: “That patient is put back on DAPT and left there,” he said.

In response to another question, Dr. Valgimigli said he doesn’t believe the lower stent thrombosis rate seen in the Endeavor Sprint group in ZEUS is unique to that stent.

“If you look at any BMS versus DES study, taking the first-generation DES out of the picture, it’s quite clear that the second-generation DES are much safer than a BMS,” according to the cardiologist.

The ZEUS study was sponsored by the University of Ferrara (Italy) and funded by Medtronic. Dr. Valgimigli serves as a consultant to and/or on speakers’ bureaus for Medtronic and more than half a dozen other pharmaceutical and medical devices companies.

[email protected]

PARIS – The use of a second-generation zotarolimus-eluting coronary stent rather than a bare metal stent in conjunction with 30 days of dual antiplatelet therapy (DAPT) in patients deemed at high bleeding risk results in lower 1-year rates of major adverse cardiovascular events and stent thrombosis, according to a prespecified analysis of the ZEUS trial presented at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Asked if the ZEUS results mean it’s time to take bare-metal stents (BMS) out of the cupboard and get rid of them, the study presenter, Dr. Marco Valgimigli, replied “I did so already.”

ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates Study) was an open-label, prospective study in which 1,606 patients undergoing urgent or emergent percutaneous coronary intervention were randomized to a thin-strut BMS or the zotarolimus-eluting Endeavor Sprint stent, a second-generation hydrophilic polymer-based device that, uniquely, elutes 100% of the drug within the first 2 weeks. All participants were placed on an intended 30-day regimen of DAPT. The study was conducted in four European countries, explained Dr. Valgimigli of Erasmus University in Rotterdam.

This prespecified analysis focused on the 828 patients with one or more factors placing them at high bleeding risk, since the use of a drug-eluting stent (DES) with a 30-day DAPT protocol hadn’t been adequately studied in that setting, the cardiologist noted.

High bleeding risk was defined by one or more of the following: age greater than 80, being on oral anticoagulation therapy, a prior bleeding event, need for corticosteroid or NSAID therapy, known anemia, or a bleeding diathesis; 47% of study participants had more than one of these criteria.

The primary study endpoint was the composite of all-cause mortality, acute MI, or target vessel revascularization through 1 year of follow-up. The rate was 29% in the BMS group, compared with 22.6% in the DES group, for a highly significant 26% relative risk reduction.

The zotarolimus-eluting stent group also fared significantly better in terms of stent thrombosis and the other prespecified secondary endpoints.

Asked how the ZEUS findings have affected his own clinical practice, Dr. Valgimigli replied, “My stent of choice in patients at high bleeding risk is a second-generation DES. Since there aren’t data showing a specific second-generation DES is preferable, basically whatever I have I implant.”

He sticks to the 30-day DAPT regimen featured in the ZEUS protocol except under specific circumstances, which were allowed under the protocol. One involves staged PCI procedures, in which case the 30 days of DAPT begins after the last stent is implanted, even though the patient has been on DAPT in the interim. The other circumstance where he goes beyond 30 days of DAPT in a patient on a second-generation DES is if an ischemic event occurs down the road: “That patient is put back on DAPT and left there,” he said.

In response to another question, Dr. Valgimigli said he doesn’t believe the lower stent thrombosis rate seen in the Endeavor Sprint group in ZEUS is unique to that stent.

“If you look at any BMS versus DES study, taking the first-generation DES out of the picture, it’s quite clear that the second-generation DES are much safer than a BMS,” according to the cardiologist.

The ZEUS study was sponsored by the University of Ferrara (Italy) and funded by Medtronic. Dr. Valgimigli serves as a consultant to and/or on speakers’ bureaus for Medtronic and more than half a dozen other pharmaceutical and medical devices companies.

[email protected]

PARIS – The use of a second-generation zotarolimus-eluting coronary stent rather than a bare metal stent in conjunction with 30 days of dual antiplatelet therapy (DAPT) in patients deemed at high bleeding risk results in lower 1-year rates of major adverse cardiovascular events and stent thrombosis, according to a prespecified analysis of the ZEUS trial presented at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Asked if the ZEUS results mean it’s time to take bare-metal stents (BMS) out of the cupboard and get rid of them, the study presenter, Dr. Marco Valgimigli, replied “I did so already.”

ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates Study) was an open-label, prospective study in which 1,606 patients undergoing urgent or emergent percutaneous coronary intervention were randomized to a thin-strut BMS or the zotarolimus-eluting Endeavor Sprint stent, a second-generation hydrophilic polymer-based device that, uniquely, elutes 100% of the drug within the first 2 weeks. All participants were placed on an intended 30-day regimen of DAPT. The study was conducted in four European countries, explained Dr. Valgimigli of Erasmus University in Rotterdam.

This prespecified analysis focused on the 828 patients with one or more factors placing them at high bleeding risk, since the use of a drug-eluting stent (DES) with a 30-day DAPT protocol hadn’t been adequately studied in that setting, the cardiologist noted.

High bleeding risk was defined by one or more of the following: age greater than 80, being on oral anticoagulation therapy, a prior bleeding event, need for corticosteroid or NSAID therapy, known anemia, or a bleeding diathesis; 47% of study participants had more than one of these criteria.

The primary study endpoint was the composite of all-cause mortality, acute MI, or target vessel revascularization through 1 year of follow-up. The rate was 29% in the BMS group, compared with 22.6% in the DES group, for a highly significant 26% relative risk reduction.

The zotarolimus-eluting stent group also fared significantly better in terms of stent thrombosis and the other prespecified secondary endpoints.

Asked how the ZEUS findings have affected his own clinical practice, Dr. Valgimigli replied, “My stent of choice in patients at high bleeding risk is a second-generation DES. Since there aren’t data showing a specific second-generation DES is preferable, basically whatever I have I implant.”

He sticks to the 30-day DAPT regimen featured in the ZEUS protocol except under specific circumstances, which were allowed under the protocol. One involves staged PCI procedures, in which case the 30 days of DAPT begins after the last stent is implanted, even though the patient has been on DAPT in the interim. The other circumstance where he goes beyond 30 days of DAPT in a patient on a second-generation DES is if an ischemic event occurs down the road: “That patient is put back on DAPT and left there,” he said.

In response to another question, Dr. Valgimigli said he doesn’t believe the lower stent thrombosis rate seen in the Endeavor Sprint group in ZEUS is unique to that stent.

“If you look at any BMS versus DES study, taking the first-generation DES out of the picture, it’s quite clear that the second-generation DES are much safer than a BMS,” according to the cardiologist.

The ZEUS study was sponsored by the University of Ferrara (Italy) and funded by Medtronic. Dr. Valgimigli serves as a consultant to and/or on speakers’ bureaus for Medtronic and more than half a dozen other pharmaceutical and medical devices companies.

[email protected]

PARIS – Thought leaders in interventional cardiology have been quick to throw cold water on recent reports of valve leaflet thickening and abnormal leaflet motion being detected in roughly 10% of patients after transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement.

“The take home message for the interventional community is there is no need for clinicians to modify their practice in relation to patient selection, TAVI implantation, or follow-up protocols. Specifically, there is no role for systematic CT or transesophageal echocardiographic follow-up of asymptomatic TAVI patients because they’re not at clinical risk, and these additional procedures carry risk in themselves,” Dr. Bernard Prendergast said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/Frontline Medical News

“Whilst there is room here for speculation and conjecture, I think most of us are confident that some of these findings may represent imaging artifact or reflect the natural history of biological valve leaflets, which has never been examined in such detail in the past,” added Dr. Prendergast, director of the cardiac structural intervention program at Guys and St. Thomas’ Hospital in London and cochair of the special EuroPCR session devoted to the emerging data on valve leaflet abnormalities.

The session featured three separate studies totaling 345 patients who underwent sophisticated, high-resolution 4D CT imaging or transesophageal echocardiography 5 days or more following TAVI or, less frequently, after surgical aortic valve replacement. Roughly 10% of patients showed a spectrum of leaflet abnormalities: thickening, mildly impaired motion, and/or thin films believed to be thrombi.

The leaflet abnormalities weren’t associated with any particular valve. And, as was emphasized by Dr. Prendergast and other speakers, to date these abnormalities haven’t been associated with a single case of stroke, systemic embolism, or valve failure.

Indeed, more than 100,000 TAVI procedures have been performed worldwide, and stroke rates in contemporary randomized trials and large registries are in the 1%-2% range. That’s better than with surgical valve replacement, Dr. Prendergast observed.

“Nowadays we can see much more than we could in the past, when we worked with 2D echocardiography,” observed discussant Dr. Jeroen J. Bax, professor of cardiology and director of noninvasive cardiology imaging at Leiden (the Netherlands) University Medical Center. “We see things that we do not completely understand. We could say that technology has outpaced our clinical understanding. But although we see things, at the moment there is no consequence in terms of hemodynamic performance or clinical outcomes. And this phenomenon of leaflet thickening has been occurring with surgical aortic valve replacement for many, many years and we simply didn’t realize it.”

Dr. Franz-Josef Neumann, who led one of the three studies, reported that 4D CT on day 5 post TAVI revealed leaflet abnormalities, all completely asymptomatic, in 16 of 154 patients. Two-thirds of the study population were on dual antiplatelet therapy at the time, the rest on a single antiplatelet agent. Dual antiplatelet therapy didn’t protect against leaflet thickening or other abnormalities.

All 16 affected patients were placed on an oral vitamin K antagonist with a target international normalized ratio (INR) of 2.5-3.5. To date, 11 of the 16 have undergone follow-up high-resolution CT after a median of 77 days. The leaflet thickening was resolved in all instances, according to Dr. Neumann, medical director of the department of cardiology and angiology at the University of Freiburg (Germany).

Bruce Jancin/Frontline Medical News

Dr. Raj R. Makkar presented a study of 125 patients who underwent high-resolution imaging after TAVI. Importantly, none of those who were on warfarin as part of their post-TAVI regimen developed leaflet abnormalities.

But he cautioned his colleagues against overreacting to the studies he and Dr. Neumann presented by placing all of their TAVI patients on an oral anticoagulant. He noted that the current TAVI population is elderly and laden with many comorbid conditions, placing them at high risk for bleeding complications.

There is at present no standard, guideline-recommended antiplatelet/antithrombotic regimen for before, during, or after TAVI. Working out the optimal protective drug regimen in this population is now a priority in light of the leaflet abnormality findings, but it will take time and require careful study, said Dr. Makkar, associate director of the Cedars Sinai Heart Institute in Los Angeles.

“Everyone is talking about anticoagulation as the imminent solution. But I want to emphasize that it comes with a price in terms of bleeding. These images are beautiful in terms of spatial resolution, but we must resist our temptation while the industry works on designing less thrombogenic valves,” the cardiologist added.

Discussant Dr. Christoph K. Naber confessed he was “stunned” by the images of leaflet abnormalities.

“Although we haven’t seen any clinical consequences, we have to keep in mind that the group of patients is still small. We have very good experience with TAVI; it has saved the lives of many patients. We know it’s a very good therapy. But if we believe we can go further and offer it to younger, lower-risk patients who will have their device for a longer time, then we should take the time and money to understand what is going on here and what consequences it could have. It’s something we should closely watch, especially if we want to extend the indication,” said Dr. Naber, director of the department of cardiology and angiology at the Contilia Cardiovascular Center in Essen, Germany.

He disclosed that he serves as a consultant to Abbott Vascular, Biotronik, Medtronic, and The Medicines Company. Dr. Makkar has received research grants from Edwards Lifesciences, St. Jude Medical, and Boston Scientific. Dr. Prendergast is on the speakers’ bureau for Edwards Lifesciences.

bjancin@frontlinemedcom

PARIS – Thought leaders in interventional cardiology have been quick to throw cold water on recent reports of valve leaflet thickening and abnormal leaflet motion being detected in roughly 10% of patients after transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement.

“The take home message for the interventional community is there is no need for clinicians to modify their practice in relation to patient selection, TAVI implantation, or follow-up protocols. Specifically, there is no role for systematic CT or transesophageal echocardiographic follow-up of asymptomatic TAVI patients because they’re not at clinical risk, and these additional procedures carry risk in themselves,” Dr. Bernard Prendergast said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/Frontline Medical News

“Whilst there is room here for speculation and conjecture, I think most of us are confident that some of these findings may represent imaging artifact or reflect the natural history of biological valve leaflets, which has never been examined in such detail in the past,” added Dr. Prendergast, director of the cardiac structural intervention program at Guys and St. Thomas’ Hospital in London and cochair of the special EuroPCR session devoted to the emerging data on valve leaflet abnormalities.

The session featured three separate studies totaling 345 patients who underwent sophisticated, high-resolution 4D CT imaging or transesophageal echocardiography 5 days or more following TAVI or, less frequently, after surgical aortic valve replacement. Roughly 10% of patients showed a spectrum of leaflet abnormalities: thickening, mildly impaired motion, and/or thin films believed to be thrombi.

The leaflet abnormalities weren’t associated with any particular valve. And, as was emphasized by Dr. Prendergast and other speakers, to date these abnormalities haven’t been associated with a single case of stroke, systemic embolism, or valve failure.

Indeed, more than 100,000 TAVI procedures have been performed worldwide, and stroke rates in contemporary randomized trials and large registries are in the 1%-2% range. That’s better than with surgical valve replacement, Dr. Prendergast observed.

“Nowadays we can see much more than we could in the past, when we worked with 2D echocardiography,” observed discussant Dr. Jeroen J. Bax, professor of cardiology and director of noninvasive cardiology imaging at Leiden (the Netherlands) University Medical Center. “We see things that we do not completely understand. We could say that technology has outpaced our clinical understanding. But although we see things, at the moment there is no consequence in terms of hemodynamic performance or clinical outcomes. And this phenomenon of leaflet thickening has been occurring with surgical aortic valve replacement for many, many years and we simply didn’t realize it.”

Dr. Franz-Josef Neumann, who led one of the three studies, reported that 4D CT on day 5 post TAVI revealed leaflet abnormalities, all completely asymptomatic, in 16 of 154 patients. Two-thirds of the study population were on dual antiplatelet therapy at the time, the rest on a single antiplatelet agent. Dual antiplatelet therapy didn’t protect against leaflet thickening or other abnormalities.

All 16 affected patients were placed on an oral vitamin K antagonist with a target international normalized ratio (INR) of 2.5-3.5. To date, 11 of the 16 have undergone follow-up high-resolution CT after a median of 77 days. The leaflet thickening was resolved in all instances, according to Dr. Neumann, medical director of the department of cardiology and angiology at the University of Freiburg (Germany).

Bruce Jancin/Frontline Medical News

Dr. Raj R. Makkar presented a study of 125 patients who underwent high-resolution imaging after TAVI. Importantly, none of those who were on warfarin as part of their post-TAVI regimen developed leaflet abnormalities.

But he cautioned his colleagues against overreacting to the studies he and Dr. Neumann presented by placing all of their TAVI patients on an oral anticoagulant. He noted that the current TAVI population is elderly and laden with many comorbid conditions, placing them at high risk for bleeding complications.

There is at present no standard, guideline-recommended antiplatelet/antithrombotic regimen for before, during, or after TAVI. Working out the optimal protective drug regimen in this population is now a priority in light of the leaflet abnormality findings, but it will take time and require careful study, said Dr. Makkar, associate director of the Cedars Sinai Heart Institute in Los Angeles.

“Everyone is talking about anticoagulation as the imminent solution. But I want to emphasize that it comes with a price in terms of bleeding. These images are beautiful in terms of spatial resolution, but we must resist our temptation while the industry works on designing less thrombogenic valves,” the cardiologist added.

Discussant Dr. Christoph K. Naber confessed he was “stunned” by the images of leaflet abnormalities.

“Although we haven’t seen any clinical consequences, we have to keep in mind that the group of patients is still small. We have very good experience with TAVI; it has saved the lives of many patients. We know it’s a very good therapy. But if we believe we can go further and offer it to younger, lower-risk patients who will have their device for a longer time, then we should take the time and money to understand what is going on here and what consequences it could have. It’s something we should closely watch, especially if we want to extend the indication,” said Dr. Naber, director of the department of cardiology and angiology at the Contilia Cardiovascular Center in Essen, Germany.

He disclosed that he serves as a consultant to Abbott Vascular, Biotronik, Medtronic, and The Medicines Company. Dr. Makkar has received research grants from Edwards Lifesciences, St. Jude Medical, and Boston Scientific. Dr. Prendergast is on the speakers’ bureau for Edwards Lifesciences.

bjancin@frontlinemedcom

PARIS – Thought leaders in interventional cardiology have been quick to throw cold water on recent reports of valve leaflet thickening and abnormal leaflet motion being detected in roughly 10% of patients after transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement.

“The take home message for the interventional community is there is no need for clinicians to modify their practice in relation to patient selection, TAVI implantation, or follow-up protocols. Specifically, there is no role for systematic CT or transesophageal echocardiographic follow-up of asymptomatic TAVI patients because they’re not at clinical risk, and these additional procedures carry risk in themselves,” Dr. Bernard Prendergast said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Bruce Jancin/Frontline Medical News

“Whilst there is room here for speculation and conjecture, I think most of us are confident that some of these findings may represent imaging artifact or reflect the natural history of biological valve leaflets, which has never been examined in such detail in the past,” added Dr. Prendergast, director of the cardiac structural intervention program at Guys and St. Thomas’ Hospital in London and cochair of the special EuroPCR session devoted to the emerging data on valve leaflet abnormalities.

The session featured three separate studies totaling 345 patients who underwent sophisticated, high-resolution 4D CT imaging or transesophageal echocardiography 5 days or more following TAVI or, less frequently, after surgical aortic valve replacement. Roughly 10% of patients showed a spectrum of leaflet abnormalities: thickening, mildly impaired motion, and/or thin films believed to be thrombi.

The leaflet abnormalities weren’t associated with any particular valve. And, as was emphasized by Dr. Prendergast and other speakers, to date these abnormalities haven’t been associated with a single case of stroke, systemic embolism, or valve failure.

Indeed, more than 100,000 TAVI procedures have been performed worldwide, and stroke rates in contemporary randomized trials and large registries are in the 1%-2% range. That’s better than with surgical valve replacement, Dr. Prendergast observed.

“Nowadays we can see much more than we could in the past, when we worked with 2D echocardiography,” observed discussant Dr. Jeroen J. Bax, professor of cardiology and director of noninvasive cardiology imaging at Leiden (the Netherlands) University Medical Center. “We see things that we do not completely understand. We could say that technology has outpaced our clinical understanding. But although we see things, at the moment there is no consequence in terms of hemodynamic performance or clinical outcomes. And this phenomenon of leaflet thickening has been occurring with surgical aortic valve replacement for many, many years and we simply didn’t realize it.”

Dr. Franz-Josef Neumann, who led one of the three studies, reported that 4D CT on day 5 post TAVI revealed leaflet abnormalities, all completely asymptomatic, in 16 of 154 patients. Two-thirds of the study population were on dual antiplatelet therapy at the time, the rest on a single antiplatelet agent. Dual antiplatelet therapy didn’t protect against leaflet thickening or other abnormalities.

All 16 affected patients were placed on an oral vitamin K antagonist with a target international normalized ratio (INR) of 2.5-3.5. To date, 11 of the 16 have undergone follow-up high-resolution CT after a median of 77 days. The leaflet thickening was resolved in all instances, according to Dr. Neumann, medical director of the department of cardiology and angiology at the University of Freiburg (Germany).

Bruce Jancin/Frontline Medical News

Dr. Raj R. Makkar presented a study of 125 patients who underwent high-resolution imaging after TAVI. Importantly, none of those who were on warfarin as part of their post-TAVI regimen developed leaflet abnormalities.

But he cautioned his colleagues against overreacting to the studies he and Dr. Neumann presented by placing all of their TAVI patients on an oral anticoagulant. He noted that the current TAVI population is elderly and laden with many comorbid conditions, placing them at high risk for bleeding complications.

There is at present no standard, guideline-recommended antiplatelet/antithrombotic regimen for before, during, or after TAVI. Working out the optimal protective drug regimen in this population is now a priority in light of the leaflet abnormality findings, but it will take time and require careful study, said Dr. Makkar, associate director of the Cedars Sinai Heart Institute in Los Angeles.

“Everyone is talking about anticoagulation as the imminent solution. But I want to emphasize that it comes with a price in terms of bleeding. These images are beautiful in terms of spatial resolution, but we must resist our temptation while the industry works on designing less thrombogenic valves,” the cardiologist added.

Discussant Dr. Christoph K. Naber confessed he was “stunned” by the images of leaflet abnormalities.

“Although we haven’t seen any clinical consequences, we have to keep in mind that the group of patients is still small. We have very good experience with TAVI; it has saved the lives of many patients. We know it’s a very good therapy. But if we believe we can go further and offer it to younger, lower-risk patients who will have their device for a longer time, then we should take the time and money to understand what is going on here and what consequences it could have. It’s something we should closely watch, especially if we want to extend the indication,” said Dr. Naber, director of the department of cardiology and angiology at the Contilia Cardiovascular Center in Essen, Germany.

He disclosed that he serves as a consultant to Abbott Vascular, Biotronik, Medtronic, and The Medicines Company. Dr. Makkar has received research grants from Edwards Lifesciences, St. Jude Medical, and Boston Scientific. Dr. Prendergast is on the speakers’ bureau for Edwards Lifesciences.

bjancin@frontlinemedcom

An acute aortic tear can be lethal, and more cardiac surgeons are favoring extended aortic arch replacement in these cases. Cardiac surgeons have tried many different arch replacement techniques, but en bloc repair and double- or triple-branch stent grafting carry significant risks, so a team of cardiac surgeons in Beijing has reported good 2-year results with a novel technique that combines stented elephant-trunk implantation with preservation of key vessels.

The technique accomplishes total arch replacement with the stent while preserving the autologous brachiocephalic vessels.

“This technique simplified hemostasis and anastomosis, reduced the size of the residual aortic patch wall, and preserved the autologous brachiocephalic vessels, yielding satisfactory surgical results,” wrote Dr. Li-Zhong Sun and colleagues at Beijing’s Capital Medical University (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.002]).

There are four keys to the procedure:

• The use of forceps to grasp the stent-free sewing edge of the stented elephant trunk and straightening of the spiral shaped Dacron graft to approximately 3 cm.

• Preservation of the native brachiocephalic vessels.

• Creating a residual aortic wall containing the innominate artery and LCCA that’s as small as possible.

• An end-to-side anastomosis between the left subclavian artery (LSCA) and the left common carotid artery (LCCA), a key junction in their technique.

The 20 study subjects had surgery within 2 weeks of the onset of pain. All 20 were discharged after the procedure, and in a mean follow-up period of 26 months, 18 had good outcomes while 1 patient had thoracoabdominal aortic replacement 9 months after the initial surgery (1 patient was lost to follow-up).

The researchers used computed tomography to confirm patency of the anastomosis between the LSCA and LCCA.

In 2 of the 20 patients, the aorta was normal with aortic dissection limited to the descending aorta. In the remaining patients, the investigators observed thrombus obliteration of the false lumen around the surgical graft in 16, partial thrombosis in 1 and patency in 1.

The surgical technique exposes the right axillary artery through a right subclavicular incision and a median sternotomy, then dissects and exposes the brachiocephalic vessels and the transverse arch. Dissection of the LSCA and LCCA is the key step in making the end-to-end anastomosis between the two vessels. The researchers accomplished this by partially transecting the sternocleidomastoid muscle and other cervical muscles.

Dr. Sun and coauthors said that a separated graft technique offers a number of advantages over other techniques for aortic arch reconstruction. While en bloc repair preserves the native brachiocephalic vessels and, thus, results in long-term patency, the technique carries risk for postoperative rupture of the aortic patch containing the brachiocephalic vessels. Double- or triple-branched stent grafting has resulted in shifting or kinking of the graft and eventually graft occlusion or aortic disruption.

The authors acknowledged the study’s small sample size, and that the outcomes are “preliminary.” They said long-term follow-up would be required to confirm the outcomes.

They had no disclosures to report.

An acute aortic tear can be lethal, and more cardiac surgeons are favoring extended aortic arch replacement in these cases. Cardiac surgeons have tried many different arch replacement techniques, but en bloc repair and double- or triple-branch stent grafting carry significant risks, so a team of cardiac surgeons in Beijing has reported good 2-year results with a novel technique that combines stented elephant-trunk implantation with preservation of key vessels.

The technique accomplishes total arch replacement with the stent while preserving the autologous brachiocephalic vessels.

“This technique simplified hemostasis and anastomosis, reduced the size of the residual aortic patch wall, and preserved the autologous brachiocephalic vessels, yielding satisfactory surgical results,” wrote Dr. Li-Zhong Sun and colleagues at Beijing’s Capital Medical University (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.002]).

There are four keys to the procedure:

• The use of forceps to grasp the stent-free sewing edge of the stented elephant trunk and straightening of the spiral shaped Dacron graft to approximately 3 cm.

• Preservation of the native brachiocephalic vessels.

• Creating a residual aortic wall containing the innominate artery and LCCA that’s as small as possible.

• An end-to-side anastomosis between the left subclavian artery (LSCA) and the left common carotid artery (LCCA), a key junction in their technique.

The 20 study subjects had surgery within 2 weeks of the onset of pain. All 20 were discharged after the procedure, and in a mean follow-up period of 26 months, 18 had good outcomes while 1 patient had thoracoabdominal aortic replacement 9 months after the initial surgery (1 patient was lost to follow-up).

The researchers used computed tomography to confirm patency of the anastomosis between the LSCA and LCCA.

In 2 of the 20 patients, the aorta was normal with aortic dissection limited to the descending aorta. In the remaining patients, the investigators observed thrombus obliteration of the false lumen around the surgical graft in 16, partial thrombosis in 1 and patency in 1.

The surgical technique exposes the right axillary artery through a right subclavicular incision and a median sternotomy, then dissects and exposes the brachiocephalic vessels and the transverse arch. Dissection of the LSCA and LCCA is the key step in making the end-to-end anastomosis between the two vessels. The researchers accomplished this by partially transecting the sternocleidomastoid muscle and other cervical muscles.

Dr. Sun and coauthors said that a separated graft technique offers a number of advantages over other techniques for aortic arch reconstruction. While en bloc repair preserves the native brachiocephalic vessels and, thus, results in long-term patency, the technique carries risk for postoperative rupture of the aortic patch containing the brachiocephalic vessels. Double- or triple-branched stent grafting has resulted in shifting or kinking of the graft and eventually graft occlusion or aortic disruption.

The authors acknowledged the study’s small sample size, and that the outcomes are “preliminary.” They said long-term follow-up would be required to confirm the outcomes.

They had no disclosures to report.

An acute aortic tear can be lethal, and more cardiac surgeons are favoring extended aortic arch replacement in these cases. Cardiac surgeons have tried many different arch replacement techniques, but en bloc repair and double- or triple-branch stent grafting carry significant risks, so a team of cardiac surgeons in Beijing has reported good 2-year results with a novel technique that combines stented elephant-trunk implantation with preservation of key vessels.

The technique accomplishes total arch replacement with the stent while preserving the autologous brachiocephalic vessels.

“This technique simplified hemostasis and anastomosis, reduced the size of the residual aortic patch wall, and preserved the autologous brachiocephalic vessels, yielding satisfactory surgical results,” wrote Dr. Li-Zhong Sun and colleagues at Beijing’s Capital Medical University (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.03.002]).

There are four keys to the procedure:

• The use of forceps to grasp the stent-free sewing edge of the stented elephant trunk and straightening of the spiral shaped Dacron graft to approximately 3 cm.

• Preservation of the native brachiocephalic vessels.

• Creating a residual aortic wall containing the innominate artery and LCCA that’s as small as possible.

• An end-to-side anastomosis between the left subclavian artery (LSCA) and the left common carotid artery (LCCA), a key junction in their technique.

The 20 study subjects had surgery within 2 weeks of the onset of pain. All 20 were discharged after the procedure, and in a mean follow-up period of 26 months, 18 had good outcomes while 1 patient had thoracoabdominal aortic replacement 9 months after the initial surgery (1 patient was lost to follow-up).

The researchers used computed tomography to confirm patency of the anastomosis between the LSCA and LCCA.

In 2 of the 20 patients, the aorta was normal with aortic dissection limited to the descending aorta. In the remaining patients, the investigators observed thrombus obliteration of the false lumen around the surgical graft in 16, partial thrombosis in 1 and patency in 1.

The surgical technique exposes the right axillary artery through a right subclavicular incision and a median sternotomy, then dissects and exposes the brachiocephalic vessels and the transverse arch. Dissection of the LSCA and LCCA is the key step in making the end-to-end anastomosis between the two vessels. The researchers accomplished this by partially transecting the sternocleidomastoid muscle and other cervical muscles.

Dr. Sun and coauthors said that a separated graft technique offers a number of advantages over other techniques for aortic arch reconstruction. While en bloc repair preserves the native brachiocephalic vessels and, thus, results in long-term patency, the technique carries risk for postoperative rupture of the aortic patch containing the brachiocephalic vessels. Double- or triple-branched stent grafting has resulted in shifting or kinking of the graft and eventually graft occlusion or aortic disruption.

The authors acknowledged the study’s small sample size, and that the outcomes are “preliminary.” They said long-term follow-up would be required to confirm the outcomes.

They had no disclosures to report.

The nature of U.S. transcatheter aortic valve replacement (TAVR) shifted dramatically in mid-June when the Food and Drug Administration, in two separate actions timed just days apart, approved marketing of next-generation models for the only two transcatheter aortic valve replacement systems on the U.S. market.

For inoperable or high-risk patients in came the Edwards Sapien 3 and the CoreValve Evolut R systems, and out went the Sapien XT and the original CoreValve. In the process the transcatheter aortic valve replacement (TAVR) procedures available to American patients on a routine basis became smaller – meaning more likely to use transfemoral approaches, less likely to cause substantial paravalvular leak, less likely to cause stroke, and in the case of the Evolut system also became repositionable and less likely to result in the need for a pacemaker.

With approvals of these two latest-generation devices, in both cases based on follow-up data of only 30 days, “we have really expanded the types of patients who can be treated with TAVR in the U.S., and we can do it with better products and get better outcomes. I am thrilled this technology will be available to patients,” said Dr. Jeffrey J. Popma, a lead investigator for the Evolut U.S. pivotal trial and professor of medicine at Harvard University in Boston.

Mitchel L. Zoler/Frontline Medical News

The pair of approvals were also notable as clear demonstration that the FDA was willing to base its decisions on 30-day follow-up data, a step closer to the approval model it applies to heart valves placed using open surgery. Perhaps most attention-grabbing of all, the FDA based its approval of the Evolut system on data from a total of 151 patients, with 60 coming from the ex-U.S. trial designed to secure a CE mark in Europe, and the other 91 patients the first ones enrolled in what was designed to be the U.S. pivotal trial for Evolut, with a planned enrollment of 250 patients that had almost fully filled by mid-June.

“This was a really good week for the FDA,” said Dr. Popma. “The FDA approved devices with reasonable assurance of safety and efficacy but without the burden of requiring 1 or more years follow-up. We are seeing a changed FDA,” he declared in an interview.

Although the full dataset for all 151 patients that the FDA used to approve the self-expanding Evolut system has not yet been released, investigators from the U.S. trial say data from their first 91 patients looked similar to the 60 patients in the CE trial, the results of which appeared in a poster in March at the annual scientific sessions of the American College of Cardiology.

The CE trial enrolled 60 symptomatic extreme- or high-risk patients at six centers in Australia, New Zealand, and the United Kingdom, who averaged 83 years old and had an average Society of Thoracic Surgeons predicted mortality estimate of 7%. Fifty-nine of the 60 patients (98%) had their TAVR done via the transfemoral route, and during 30-day follow-up no patients died and none had a stroke. The researchers identified a moderate or severe paravalvular leak in 3% of patients after 30 days, and 12% of patients had a new need for a pacemaker. By comparison, in the CoreValve pivotal trial for the first-generation version of this self-expanding valve, death occurred in 3% of patients after 30 days, major strokes in 4%, moderate or severe paravalvular leaks occurred in 9%, and 20% of patients by that point had required placement of a new pacemaker (N. Engl. J. Med. 2014;370:1790-8).

The striking reductions in more severe paravalvular leaks and in the need for a pacemaker likely related at least in part to the ability to reposition the Evolut valve during placement as long as the valve was not more than 80% deployed and as long as retrieval was not attempted more than three times.

Repositioning is “huge” said Dr. Mathew R. Williams, chief of adult cardiac surgery and director of interventional cardiology at New York University, and one of two lead investigators on the U.S. CoreValve Evolut R pivotal trial. “We don’t need to use it most of the time, but having that ability reduces stress and helps make the operator more comfortable,” he said in an interview. The more optimized positioning allowed by the recapture feature likely helped minimize both paravalvular leaks and the valve’s ability to trigger an arrhythmia and need for pacing. In the CE trial the operator used the repositioning function in 15 patients (25%) for a total of 22 repositioning events.

Like Dr. Popma, Dr. Williams welcomed the June 17 approval of the Sapien 3 TAVR system, based on 30-day outcomes from all 583 patients enrolled in the U.S. pivotal trial. Results from that study became public last March in a late-breaker report at the American College of Cardiology meeting.

Mitchel L. Zoler/Frontline Medical News

Sapien 3 treatment of high-risk, symptomatic patients, who averaged 83 years old and had a STS predicted mortality rate of 8.6%, resulted in a 2% mortality rate, a 1.5% stroke rate, a 3% rate of moderate or severe paravalvular leaks, and 13% of patients had a new need for a pacemaker, Dr. Susheel Kodali reported when he presented these data in March. Trial investigators were able to place the Sapien 3 aortic valve via a transfemoral approach in 491 of the 583 patients (84%) enrolled in the study. The adverse outcomes with Sapien 3 contrasted with rates for the prior Sapien XT TAVR system of 3.5% for 30-day mortality, 4.3% for strokes, and a 24% rate of moderate or severe paravalvular leak, said Dr. Kodali, director of the heart valve program at Columbia University in New York.

While the Sapien 3 and Evolut systems appeared to produce roughly similar outcomes for parameters like 30-day mortality, stroke, and paravalvular leak rates, with both systems outperforming what they displaced, the Evolut has two important differences, compared with Sapien 3. First, the Evolut is slightly smaller, with the ability to traverse arteries as narrow as 5 mm, whereas the minimum vessel size for Sapien 3 passage is 5.5 mm; second, Evolute is repositionable, while Sapien 3 is not.

The CoreValve Evolut R trials were sponsored by Medtronic. Dr. Popma has received research grants from and served as a speaker on behalf of Medtronic. He has also been a speaker for Abbott Vascular, Boston Scientific, Covidien, Cook Medical, and Direct Flow Medical and has received research support from five other companies. Dr. Williams has been a consultant to and received research support from Medtronic and has also been a consultant to Edwards and Direct Flow Medical. The Sapien 3 trial was sponsored by Edwards. Dr. Kodali has received research support from Edwards, has an equity interest in Thubrikar Aortic Valve, has received honoraria from St. Jude, and has served on the steering committee for trials sponsored by Claret Medical and Meril.

[email protected]

On Twitter @mitchelzoler

The nature of U.S. transcatheter aortic valve replacement (TAVR) shifted dramatically in mid-June when the Food and Drug Administration, in two separate actions timed just days apart, approved marketing of next-generation models for the only two transcatheter aortic valve replacement systems on the U.S. market.

For inoperable or high-risk patients in came the Edwards Sapien 3 and the CoreValve Evolut R systems, and out went the Sapien XT and the original CoreValve. In the process the transcatheter aortic valve replacement (TAVR) procedures available to American patients on a routine basis became smaller – meaning more likely to use transfemoral approaches, less likely to cause substantial paravalvular leak, less likely to cause stroke, and in the case of the Evolut system also became repositionable and less likely to result in the need for a pacemaker.

With approvals of these two latest-generation devices, in both cases based on follow-up data of only 30 days, “we have really expanded the types of patients who can be treated with TAVR in the U.S., and we can do it with better products and get better outcomes. I am thrilled this technology will be available to patients,” said Dr. Jeffrey J. Popma, a lead investigator for the Evolut U.S. pivotal trial and professor of medicine at Harvard University in Boston.

Mitchel L. Zoler/Frontline Medical News

The pair of approvals were also notable as clear demonstration that the FDA was willing to base its decisions on 30-day follow-up data, a step closer to the approval model it applies to heart valves placed using open surgery. Perhaps most attention-grabbing of all, the FDA based its approval of the Evolut system on data from a total of 151 patients, with 60 coming from the ex-U.S. trial designed to secure a CE mark in Europe, and the other 91 patients the first ones enrolled in what was designed to be the U.S. pivotal trial for Evolut, with a planned enrollment of 250 patients that had almost fully filled by mid-June.

“This was a really good week for the FDA,” said Dr. Popma. “The FDA approved devices with reasonable assurance of safety and efficacy but without the burden of requiring 1 or more years follow-up. We are seeing a changed FDA,” he declared in an interview.

Although the full dataset for all 151 patients that the FDA used to approve the self-expanding Evolut system has not yet been released, investigators from the U.S. trial say data from their first 91 patients looked similar to the 60 patients in the CE trial, the results of which appeared in a poster in March at the annual scientific sessions of the American College of Cardiology.

The CE trial enrolled 60 symptomatic extreme- or high-risk patients at six centers in Australia, New Zealand, and the United Kingdom, who averaged 83 years old and had an average Society of Thoracic Surgeons predicted mortality estimate of 7%. Fifty-nine of the 60 patients (98%) had their TAVR done via the transfemoral route, and during 30-day follow-up no patients died and none had a stroke. The researchers identified a moderate or severe paravalvular leak in 3% of patients after 30 days, and 12% of patients had a new need for a pacemaker. By comparison, in the CoreValve pivotal trial for the first-generation version of this self-expanding valve, death occurred in 3% of patients after 30 days, major strokes in 4%, moderate or severe paravalvular leaks occurred in 9%, and 20% of patients by that point had required placement of a new pacemaker (N. Engl. J. Med. 2014;370:1790-8).

The striking reductions in more severe paravalvular leaks and in the need for a pacemaker likely related at least in part to the ability to reposition the Evolut valve during placement as long as the valve was not more than 80% deployed and as long as retrieval was not attempted more than three times.

Repositioning is “huge” said Dr. Mathew R. Williams, chief of adult cardiac surgery and director of interventional cardiology at New York University, and one of two lead investigators on the U.S. CoreValve Evolut R pivotal trial. “We don’t need to use it most of the time, but having that ability reduces stress and helps make the operator more comfortable,” he said in an interview. The more optimized positioning allowed by the recapture feature likely helped minimize both paravalvular leaks and the valve’s ability to trigger an arrhythmia and need for pacing. In the CE trial the operator used the repositioning function in 15 patients (25%) for a total of 22 repositioning events.

Like Dr. Popma, Dr. Williams welcomed the June 17 approval of the Sapien 3 TAVR system, based on 30-day outcomes from all 583 patients enrolled in the U.S. pivotal trial. Results from that study became public last March in a late-breaker report at the American College of Cardiology meeting.

Mitchel L. Zoler/Frontline Medical News

Sapien 3 treatment of high-risk, symptomatic patients, who averaged 83 years old and had a STS predicted mortality rate of 8.6%, resulted in a 2% mortality rate, a 1.5% stroke rate, a 3% rate of moderate or severe paravalvular leaks, and 13% of patients had a new need for a pacemaker, Dr. Susheel Kodali reported when he presented these data in March. Trial investigators were able to place the Sapien 3 aortic valve via a transfemoral approach in 491 of the 583 patients (84%) enrolled in the study. The adverse outcomes with Sapien 3 contrasted with rates for the prior Sapien XT TAVR system of 3.5% for 30-day mortality, 4.3% for strokes, and a 24% rate of moderate or severe paravalvular leak, said Dr. Kodali, director of the heart valve program at Columbia University in New York.

While the Sapien 3 and Evolut systems appeared to produce roughly similar outcomes for parameters like 30-day mortality, stroke, and paravalvular leak rates, with both systems outperforming what they displaced, the Evolut has two important differences, compared with Sapien 3. First, the Evolut is slightly smaller, with the ability to traverse arteries as narrow as 5 mm, whereas the minimum vessel size for Sapien 3 passage is 5.5 mm; second, Evolute is repositionable, while Sapien 3 is not.

The CoreValve Evolut R trials were sponsored by Medtronic. Dr. Popma has received research grants from and served as a speaker on behalf of Medtronic. He has also been a speaker for Abbott Vascular, Boston Scientific, Covidien, Cook Medical, and Direct Flow Medical and has received research support from five other companies. Dr. Williams has been a consultant to and received research support from Medtronic and has also been a consultant to Edwards and Direct Flow Medical. The Sapien 3 trial was sponsored by Edwards. Dr. Kodali has received research support from Edwards, has an equity interest in Thubrikar Aortic Valve, has received honoraria from St. Jude, and has served on the steering committee for trials sponsored by Claret Medical and Meril.

[email protected]

On Twitter @mitchelzoler

The nature of U.S. transcatheter aortic valve replacement (TAVR) shifted dramatically in mid-June when the Food and Drug Administration, in two separate actions timed just days apart, approved marketing of next-generation models for the only two transcatheter aortic valve replacement systems on the U.S. market.

For inoperable or high-risk patients in came the Edwards Sapien 3 and the CoreValve Evolut R systems, and out went the Sapien XT and the original CoreValve. In the process the transcatheter aortic valve replacement (TAVR) procedures available to American patients on a routine basis became smaller – meaning more likely to use transfemoral approaches, less likely to cause substantial paravalvular leak, less likely to cause stroke, and in the case of the Evolut system also became repositionable and less likely to result in the need for a pacemaker.

With approvals of these two latest-generation devices, in both cases based on follow-up data of only 30 days, “we have really expanded the types of patients who can be treated with TAVR in the U.S., and we can do it with better products and get better outcomes. I am thrilled this technology will be available to patients,” said Dr. Jeffrey J. Popma, a lead investigator for the Evolut U.S. pivotal trial and professor of medicine at Harvard University in Boston.

Mitchel L. Zoler/Frontline Medical News

The pair of approvals were also notable as clear demonstration that the FDA was willing to base its decisions on 30-day follow-up data, a step closer to the approval model it applies to heart valves placed using open surgery. Perhaps most attention-grabbing of all, the FDA based its approval of the Evolut system on data from a total of 151 patients, with 60 coming from the ex-U.S. trial designed to secure a CE mark in Europe, and the other 91 patients the first ones enrolled in what was designed to be the U.S. pivotal trial for Evolut, with a planned enrollment of 250 patients that had almost fully filled by mid-June.

“This was a really good week for the FDA,” said Dr. Popma. “The FDA approved devices with reasonable assurance of safety and efficacy but without the burden of requiring 1 or more years follow-up. We are seeing a changed FDA,” he declared in an interview.

Although the full dataset for all 151 patients that the FDA used to approve the self-expanding Evolut system has not yet been released, investigators from the U.S. trial say data from their first 91 patients looked similar to the 60 patients in the CE trial, the results of which appeared in a poster in March at the annual scientific sessions of the American College of Cardiology.

The CE trial enrolled 60 symptomatic extreme- or high-risk patients at six centers in Australia, New Zealand, and the United Kingdom, who averaged 83 years old and had an average Society of Thoracic Surgeons predicted mortality estimate of 7%. Fifty-nine of the 60 patients (98%) had their TAVR done via the transfemoral route, and during 30-day follow-up no patients died and none had a stroke. The researchers identified a moderate or severe paravalvular leak in 3% of patients after 30 days, and 12% of patients had a new need for a pacemaker. By comparison, in the CoreValve pivotal trial for the first-generation version of this self-expanding valve, death occurred in 3% of patients after 30 days, major strokes in 4%, moderate or severe paravalvular leaks occurred in 9%, and 20% of patients by that point had required placement of a new pacemaker (N. Engl. J. Med. 2014;370:1790-8).

The striking reductions in more severe paravalvular leaks and in the need for a pacemaker likely related at least in part to the ability to reposition the Evolut valve during placement as long as the valve was not more than 80% deployed and as long as retrieval was not attempted more than three times.

Repositioning is “huge” said Dr. Mathew R. Williams, chief of adult cardiac surgery and director of interventional cardiology at New York University, and one of two lead investigators on the U.S. CoreValve Evolut R pivotal trial. “We don’t need to use it most of the time, but having that ability reduces stress and helps make the operator more comfortable,” he said in an interview. The more optimized positioning allowed by the recapture feature likely helped minimize both paravalvular leaks and the valve’s ability to trigger an arrhythmia and need for pacing. In the CE trial the operator used the repositioning function in 15 patients (25%) for a total of 22 repositioning events.

Like Dr. Popma, Dr. Williams welcomed the June 17 approval of the Sapien 3 TAVR system, based on 30-day outcomes from all 583 patients enrolled in the U.S. pivotal trial. Results from that study became public last March in a late-breaker report at the American College of Cardiology meeting.

Mitchel L. Zoler/Frontline Medical News

Sapien 3 treatment of high-risk, symptomatic patients, who averaged 83 years old and had a STS predicted mortality rate of 8.6%, resulted in a 2% mortality rate, a 1.5% stroke rate, a 3% rate of moderate or severe paravalvular leaks, and 13% of patients had a new need for a pacemaker, Dr. Susheel Kodali reported when he presented these data in March. Trial investigators were able to place the Sapien 3 aortic valve via a transfemoral approach in 491 of the 583 patients (84%) enrolled in the study. The adverse outcomes with Sapien 3 contrasted with rates for the prior Sapien XT TAVR system of 3.5% for 30-day mortality, 4.3% for strokes, and a 24% rate of moderate or severe paravalvular leak, said Dr. Kodali, director of the heart valve program at Columbia University in New York.

While the Sapien 3 and Evolut systems appeared to produce roughly similar outcomes for parameters like 30-day mortality, stroke, and paravalvular leak rates, with both systems outperforming what they displaced, the Evolut has two important differences, compared with Sapien 3. First, the Evolut is slightly smaller, with the ability to traverse arteries as narrow as 5 mm, whereas the minimum vessel size for Sapien 3 passage is 5.5 mm; second, Evolute is repositionable, while Sapien 3 is not.

The CoreValve Evolut R trials were sponsored by Medtronic. Dr. Popma has received research grants from and served as a speaker on behalf of Medtronic. He has also been a speaker for Abbott Vascular, Boston Scientific, Covidien, Cook Medical, and Direct Flow Medical and has received research support from five other companies. Dr. Williams has been a consultant to and received research support from Medtronic and has also been a consultant to Edwards and Direct Flow Medical. The Sapien 3 trial was sponsored by Edwards. Dr. Kodali has received research support from Edwards, has an equity interest in Thubrikar Aortic Valve, has received honoraria from St. Jude, and has served on the steering committee for trials sponsored by Claret Medical and Meril.

[email protected]

On Twitter @mitchelzoler

SEATTLE – Aortic valve–sparing procedures have better outcomes than Bentall procedures with biologic or mechanical valves, according to a review of 1,187 aortic root cases at the University of Toronto.

“If the aortic valve can be spared, AVS [aortic valve–sparing] procedures should be considered for patients undergoing aortic root replacement,” concluded the investigators, led by Dr. Maral Ouzounian, a cardiovascular surgeon at the university.

Alex Otto/Frontline Medical News

The team reviewed surgical outcomes there from 1990 to 2010; 282 patients had AVS procedures, 562 had Bentall procedures with biologic valve replacements (b-Bentall); and 343 had Bentalls with mechanical valve replacements (m-Bentall). About 7.5% of AVS patients had bicuspid aortic valves, versus 67.6% in the b-Bentall group and 51.7% in the m-Bentall group.

To control for confounders, patients were matched into 185 triads based on age, year of surgery, and stage of heart failure. The surgeries were all elective; patients with endocarditis or aortic dissections were excluded from the analysis.

Early postoperative outcomes and overall long-term survival were similar between the groups, with about 80% of patients in all three alive at 15-year follow-up.

However, AVS procedures had better long-term freedom from cardiac death (95% at 15 years versus 93% in the b-Bentall and 90% in the m-Bentall groups). Also, AVS patients had lower rates of anticoagulant-related hemorrhages, compared with m-Bentall patients (3.2% versus 17.8%), and lower rates of structural valve deterioration (0% versus 6.5%) and reoperations (6.5% versus 13.5%) than b-Bentall patients. The differences were statistically significant.

About 5% of AVS patients had previous cardiac surgery, versus 12.4% in the b-Bentall and 36.2% in the m-Bentall groups. AVS patients were more likely to have Marfan syndrome, and about 8% of AVS patients had preoperative ejection fractions below 40%, versus 9.3% in the b-Bentall and 13% in the m-Bentall groups. There were no between-group differences in the rates of concomitant coronary bypass or mitral valve surgery. Patients were about 50 years old on average, and about 80% were men.

“In Toronto, we are quite aggressive with valve-sparing operations. We believe in this operation, so whenever we can spare the valve, we do.” Although valve-sparing procedures have become more common in large, high-volume surgery centers over the past 20 years, “community surgeons in small-volume centers are still much more likely to do a Bentall because of the complexity of AVS operations and the art it takes to get it right,” Dr. Ouzounian said at the annual meeting of the American Association for Thoracic Surgery.

Previous investigations have found benefits for AVS procedures, as well. One concluded that “there is no significant difference in terms of re-operation between patients, who presented with [bicuspid or tricuspid aortic valves]. Re-operation rates are higher for patients who presented with severe [aortic regurgitation], but these rates do not reach statistical significance. Hence, root replacement with aortic valve sparing should be offered even in the presence of a” bicuspid aortic valve or severe aortic regurgitation (Eur. J. Cardiothorac. Surg. 2010;38:515-22).

Dr. Ouzounian said she has no disclosures.

[email protected]

SEATTLE – Aortic valve–sparing procedures have better outcomes than Bentall procedures with biologic or mechanical valves, according to a review of 1,187 aortic root cases at the University of Toronto.

“If the aortic valve can be spared, AVS [aortic valve–sparing] procedures should be considered for patients undergoing aortic root replacement,” concluded the investigators, led by Dr. Maral Ouzounian, a cardiovascular surgeon at the university.

Alex Otto/Frontline Medical News

The team reviewed surgical outcomes there from 1990 to 2010; 282 patients had AVS procedures, 562 had Bentall procedures with biologic valve replacements (b-Bentall); and 343 had Bentalls with mechanical valve replacements (m-Bentall). About 7.5% of AVS patients had bicuspid aortic valves, versus 67.6% in the b-Bentall group and 51.7% in the m-Bentall group.

To control for confounders, patients were matched into 185 triads based on age, year of surgery, and stage of heart failure. The surgeries were all elective; patients with endocarditis or aortic dissections were excluded from the analysis.

Early postoperative outcomes and overall long-term survival were similar between the groups, with about 80% of patients in all three alive at 15-year follow-up.

However, AVS procedures had better long-term freedom from cardiac death (95% at 15 years versus 93% in the b-Bentall and 90% in the m-Bentall groups). Also, AVS patients had lower rates of anticoagulant-related hemorrhages, compared with m-Bentall patients (3.2% versus 17.8%), and lower rates of structural valve deterioration (0% versus 6.5%) and reoperations (6.5% versus 13.5%) than b-Bentall patients. The differences were statistically significant.

About 5% of AVS patients had previous cardiac surgery, versus 12.4% in the b-Bentall and 36.2% in the m-Bentall groups. AVS patients were more likely to have Marfan syndrome, and about 8% of AVS patients had preoperative ejection fractions below 40%, versus 9.3% in the b-Bentall and 13% in the m-Bentall groups. There were no between-group differences in the rates of concomitant coronary bypass or mitral valve surgery. Patients were about 50 years old on average, and about 80% were men.

“In Toronto, we are quite aggressive with valve-sparing operations. We believe in this operation, so whenever we can spare the valve, we do.” Although valve-sparing procedures have become more common in large, high-volume surgery centers over the past 20 years, “community surgeons in small-volume centers are still much more likely to do a Bentall because of the complexity of AVS operations and the art it takes to get it right,” Dr. Ouzounian said at the annual meeting of the American Association for Thoracic Surgery.

Previous investigations have found benefits for AVS procedures, as well. One concluded that “there is no significant difference in terms of re-operation between patients, who presented with [bicuspid or tricuspid aortic valves]. Re-operation rates are higher for patients who presented with severe [aortic regurgitation], but these rates do not reach statistical significance. Hence, root replacement with aortic valve sparing should be offered even in the presence of a” bicuspid aortic valve or severe aortic regurgitation (Eur. J. Cardiothorac. Surg. 2010;38:515-22).

Dr. Ouzounian said she has no disclosures.

[email protected]

SEATTLE – Aortic valve–sparing procedures have better outcomes than Bentall procedures with biologic or mechanical valves, according to a review of 1,187 aortic root cases at the University of Toronto.

“If the aortic valve can be spared, AVS [aortic valve–sparing] procedures should be considered for patients undergoing aortic root replacement,” concluded the investigators, led by Dr. Maral Ouzounian, a cardiovascular surgeon at the university.

Alex Otto/Frontline Medical News

The team reviewed surgical outcomes there from 1990 to 2010; 282 patients had AVS procedures, 562 had Bentall procedures with biologic valve replacements (b-Bentall); and 343 had Bentalls with mechanical valve replacements (m-Bentall). About 7.5% of AVS patients had bicuspid aortic valves, versus 67.6% in the b-Bentall group and 51.7% in the m-Bentall group.

To control for confounders, patients were matched into 185 triads based on age, year of surgery, and stage of heart failure. The surgeries were all elective; patients with endocarditis or aortic dissections were excluded from the analysis.

Early postoperative outcomes and overall long-term survival were similar between the groups, with about 80% of patients in all three alive at 15-year follow-up.

However, AVS procedures had better long-term freedom from cardiac death (95% at 15 years versus 93% in the b-Bentall and 90% in the m-Bentall groups). Also, AVS patients had lower rates of anticoagulant-related hemorrhages, compared with m-Bentall patients (3.2% versus 17.8%), and lower rates of structural valve deterioration (0% versus 6.5%) and reoperations (6.5% versus 13.5%) than b-Bentall patients. The differences were statistically significant.

About 5% of AVS patients had previous cardiac surgery, versus 12.4% in the b-Bentall and 36.2% in the m-Bentall groups. AVS patients were more likely to have Marfan syndrome, and about 8% of AVS patients had preoperative ejection fractions below 40%, versus 9.3% in the b-Bentall and 13% in the m-Bentall groups. There were no between-group differences in the rates of concomitant coronary bypass or mitral valve surgery. Patients were about 50 years old on average, and about 80% were men.

“In Toronto, we are quite aggressive with valve-sparing operations. We believe in this operation, so whenever we can spare the valve, we do.” Although valve-sparing procedures have become more common in large, high-volume surgery centers over the past 20 years, “community surgeons in small-volume centers are still much more likely to do a Bentall because of the complexity of AVS operations and the art it takes to get it right,” Dr. Ouzounian said at the annual meeting of the American Association for Thoracic Surgery.

Previous investigations have found benefits for AVS procedures, as well. One concluded that “there is no significant difference in terms of re-operation between patients, who presented with [bicuspid or tricuspid aortic valves]. Re-operation rates are higher for patients who presented with severe [aortic regurgitation], but these rates do not reach statistical significance. Hence, root replacement with aortic valve sparing should be offered even in the presence of a” bicuspid aortic valve or severe aortic regurgitation (Eur. J. Cardiothorac. Surg. 2010;38:515-22).

Dr. Ouzounian said she has no disclosures.

[email protected]

PARIS – Noninvasive measurement of computed tomography–derived fractional flow reserve is a potential game changer in the management of patients with stable chest pain.

In a 200-patient proof-of-concept study known as FFR-CT RIPCORD, in which three experienced interventional cardiologists initially devised management plans based on coronary anatomy as defined by the results of CT angiography alone, subsequent knowledge of CT-derived fractional flow reserve (FFR-CT) caused them to change their management strategies in fully 36% of cases, Dr. Nick Curzen reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“If this novel proof-of-concept result can be confirmed in large-scale trials, this suggests that noninvasive FFR-CT can be used as a clinically relevant tool that mimics the well-described ability of invasive FFR to refine management decisions for patients with chest pain that are made by invasive coronary angiography alone. This would indeed have important implications for routine clinical practice. FFR-CT may have potential as a noninvasive default method for simultaneous assessment of coronary anatomy and physiology in angina patients in order to define their management, which would completely change the way we look after them,” observed Dr. Curzen, professor of interventional cardiology at the University of Southampton (England).

EuroPCR codirector Dr. Williams Wijns was favorably impressed by the FFR-CT RIPCORD findings.

“This, I find just stunning. It’s really far reaching. This is a complete change in paradigm. Many patients that today undergo invasive angiography won’t even be sent to the cath lab. The invasive center becomes only for treatment,” commented Dr. Wijns, codirector of the cardiovascular center in Aalst, Belgium.

In FFR-CT RIPCORD, the cardiologists received information about a patient’s history and nonvasive CT angiography findings and were asked to reach consensus in selecting one of four management options: optimal medical therapy (OMT) alone, PCI plus OMT, CABG surgery and OMT, or ‘more information needed’ in the form of FFR findings, which identify those coronary lesions that are actually causing ischemia. Instead of receiving the results of conventional invasive FFR obtained using a pressure wire, however, the cardiologists were provided with the noninvasive FFR-CT findings in all 200 cases.

The resultant changes in management were substantial. Thirty percent of the patients initially slated for PCI were reallocated to OMT alone because no ischemic lesions were present. Twelve percent of patients assigned to OMT-only got reassigned to coronary revascularization. Moreover, in 18% of the PCI group, FFR-CT data led to a change in the vessel or vessels targeted for intervention.

“What particularly impressed me were two of those figures: that one-third of PCI patients are redirected to medical therapy, and – even more impressive to me – is the 18% of PCI patients who had a change in their target vessel. That’s a problem we often have in patients with multivessel disease and intermediate lesions: Sometimes we think, for example, the target is the LAD when in fact it’s another vessel,” commented Dr. Jean Fajadet, codirector of the interventional cardiovascular group at the Clinique Pasteur in Toulouse, France.

Dr. Curzen said the exciting thing about FFR-CT is that it could provide in one fell swoop a standardized way of obtaining both the anatomic and physiologic data necessary for informed clinical decision making, and without exposing patients needlessly to the risks of contrast and radiation exposure entailed in invasive coronary angiography.

“When we assess people with stable angina, if you have a room full of invasive cardiologists, we all do it differently at the moment. It’s crazy. A lot of us will do noninvasive tests like stress echo or MRI or some kind of exercise test, and then refer them for an invasive angiogram where we’ll also do an FFR. Some people will go straight for an angiogram. It’s a real mess. The thing I love about FFR-CT is it would be so slick for patients and their families: You see them in a chest pain clinic or your office and you put them in for this test. They don’t have to waste their time coming back several times for different tests. It’s a really beautiful concept,” Dr. Curzen continued.

Right now the turnaround time on FFR-CT is about 12 hours. The dataset has to be sent off to a supercomputer for a complex modeling analysis before the results come back.

“Of course, if this ever becomes clinically proven, I’m sure the turnaround time would become very quick,” according to the cardiologist.

A cost-effectiveness analysis of FFR-CT versus current standard care is ongoing and the results aren’t yet available. However, Dr. Curzen observed, “The cost to the patient is a very important issue: Who would want to have this done invasively if you have a test that proves you don’t need to have an invasive procedure?”

The FFR-CT RIPCORD study was sponsored by Heartflow. Dr. Curzen reported receiving research support from Heartflow, Boston Scientific, Haemonetics, and Medtronic.

[email protected]

PARIS – Noninvasive measurement of computed tomography–derived fractional flow reserve is a potential game changer in the management of patients with stable chest pain.

In a 200-patient proof-of-concept study known as FFR-CT RIPCORD, in which three experienced interventional cardiologists initially devised management plans based on coronary anatomy as defined by the results of CT angiography alone, subsequent knowledge of CT-derived fractional flow reserve (FFR-CT) caused them to change their management strategies in fully 36% of cases, Dr. Nick Curzen reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“If this novel proof-of-concept result can be confirmed in large-scale trials, this suggests that noninvasive FFR-CT can be used as a clinically relevant tool that mimics the well-described ability of invasive FFR to refine management decisions for patients with chest pain that are made by invasive coronary angiography alone. This would indeed have important implications for routine clinical practice. FFR-CT may have potential as a noninvasive default method for simultaneous assessment of coronary anatomy and physiology in angina patients in order to define their management, which would completely change the way we look after them,” observed Dr. Curzen, professor of interventional cardiology at the University of Southampton (England).

EuroPCR codirector Dr. Williams Wijns was favorably impressed by the FFR-CT RIPCORD findings.

“This, I find just stunning. It’s really far reaching. This is a complete change in paradigm. Many patients that today undergo invasive angiography won’t even be sent to the cath lab. The invasive center becomes only for treatment,” commented Dr. Wijns, codirector of the cardiovascular center in Aalst, Belgium.

In FFR-CT RIPCORD, the cardiologists received information about a patient’s history and nonvasive CT angiography findings and were asked to reach consensus in selecting one of four management options: optimal medical therapy (OMT) alone, PCI plus OMT, CABG surgery and OMT, or ‘more information needed’ in the form of FFR findings, which identify those coronary lesions that are actually causing ischemia. Instead of receiving the results of conventional invasive FFR obtained using a pressure wire, however, the cardiologists were provided with the noninvasive FFR-CT findings in all 200 cases.

The resultant changes in management were substantial. Thirty percent of the patients initially slated for PCI were reallocated to OMT alone because no ischemic lesions were present. Twelve percent of patients assigned to OMT-only got reassigned to coronary revascularization. Moreover, in 18% of the PCI group, FFR-CT data led to a change in the vessel or vessels targeted for intervention.

“What particularly impressed me were two of those figures: that one-third of PCI patients are redirected to medical therapy, and – even more impressive to me – is the 18% of PCI patients who had a change in their target vessel. That’s a problem we often have in patients with multivessel disease and intermediate lesions: Sometimes we think, for example, the target is the LAD when in fact it’s another vessel,” commented Dr. Jean Fajadet, codirector of the interventional cardiovascular group at the Clinique Pasteur in Toulouse, France.

Dr. Curzen said the exciting thing about FFR-CT is that it could provide in one fell swoop a standardized way of obtaining both the anatomic and physiologic data necessary for informed clinical decision making, and without exposing patients needlessly to the risks of contrast and radiation exposure entailed in invasive coronary angiography.

“When we assess people with stable angina, if you have a room full of invasive cardiologists, we all do it differently at the moment. It’s crazy. A lot of us will do noninvasive tests like stress echo or MRI or some kind of exercise test, and then refer them for an invasive angiogram where we’ll also do an FFR. Some people will go straight for an angiogram. It’s a real mess. The thing I love about FFR-CT is it would be so slick for patients and their families: You see them in a chest pain clinic or your office and you put them in for this test. They don’t have to waste their time coming back several times for different tests. It’s a really beautiful concept,” Dr. Curzen continued.

Right now the turnaround time on FFR-CT is about 12 hours. The dataset has to be sent off to a supercomputer for a complex modeling analysis before the results come back.

“Of course, if this ever becomes clinically proven, I’m sure the turnaround time would become very quick,” according to the cardiologist.

A cost-effectiveness analysis of FFR-CT versus current standard care is ongoing and the results aren’t yet available. However, Dr. Curzen observed, “The cost to the patient is a very important issue: Who would want to have this done invasively if you have a test that proves you don’t need to have an invasive procedure?”

The FFR-CT RIPCORD study was sponsored by Heartflow. Dr. Curzen reported receiving research support from Heartflow, Boston Scientific, Haemonetics, and Medtronic.

[email protected]

PARIS – Noninvasive measurement of computed tomography–derived fractional flow reserve is a potential game changer in the management of patients with stable chest pain.

In a 200-patient proof-of-concept study known as FFR-CT RIPCORD, in which three experienced interventional cardiologists initially devised management plans based on coronary anatomy as defined by the results of CT angiography alone, subsequent knowledge of CT-derived fractional flow reserve (FFR-CT) caused them to change their management strategies in fully 36% of cases, Dr. Nick Curzen reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“If this novel proof-of-concept result can be confirmed in large-scale trials, this suggests that noninvasive FFR-CT can be used as a clinically relevant tool that mimics the well-described ability of invasive FFR to refine management decisions for patients with chest pain that are made by invasive coronary angiography alone. This would indeed have important implications for routine clinical practice. FFR-CT may have potential as a noninvasive default method for simultaneous assessment of coronary anatomy and physiology in angina patients in order to define their management, which would completely change the way we look after them,” observed Dr. Curzen, professor of interventional cardiology at the University of Southampton (England).

EuroPCR codirector Dr. Williams Wijns was favorably impressed by the FFR-CT RIPCORD findings.

“This, I find just stunning. It’s really far reaching. This is a complete change in paradigm. Many patients that today undergo invasive angiography won’t even be sent to the cath lab. The invasive center becomes only for treatment,” commented Dr. Wijns, codirector of the cardiovascular center in Aalst, Belgium.

In FFR-CT RIPCORD, the cardiologists received information about a patient’s history and nonvasive CT angiography findings and were asked to reach consensus in selecting one of four management options: optimal medical therapy (OMT) alone, PCI plus OMT, CABG surgery and OMT, or ‘more information needed’ in the form of FFR findings, which identify those coronary lesions that are actually causing ischemia. Instead of receiving the results of conventional invasive FFR obtained using a pressure wire, however, the cardiologists were provided with the noninvasive FFR-CT findings in all 200 cases.

The resultant changes in management were substantial. Thirty percent of the patients initially slated for PCI were reallocated to OMT alone because no ischemic lesions were present. Twelve percent of patients assigned to OMT-only got reassigned to coronary revascularization. Moreover, in 18% of the PCI group, FFR-CT data led to a change in the vessel or vessels targeted for intervention.

“What particularly impressed me were two of those figures: that one-third of PCI patients are redirected to medical therapy, and – even more impressive to me – is the 18% of PCI patients who had a change in their target vessel. That’s a problem we often have in patients with multivessel disease and intermediate lesions: Sometimes we think, for example, the target is the LAD when in fact it’s another vessel,” commented Dr. Jean Fajadet, codirector of the interventional cardiovascular group at the Clinique Pasteur in Toulouse, France.

Dr. Curzen said the exciting thing about FFR-CT is that it could provide in one fell swoop a standardized way of obtaining both the anatomic and physiologic data necessary for informed clinical decision making, and without exposing patients needlessly to the risks of contrast and radiation exposure entailed in invasive coronary angiography.

“When we assess people with stable angina, if you have a room full of invasive cardiologists, we all do it differently at the moment. It’s crazy. A lot of us will do noninvasive tests like stress echo or MRI or some kind of exercise test, and then refer them for an invasive angiogram where we’ll also do an FFR. Some people will go straight for an angiogram. It’s a real mess. The thing I love about FFR-CT is it would be so slick for patients and their families: You see them in a chest pain clinic or your office and you put them in for this test. They don’t have to waste their time coming back several times for different tests. It’s a really beautiful concept,” Dr. Curzen continued.

Right now the turnaround time on FFR-CT is about 12 hours. The dataset has to be sent off to a supercomputer for a complex modeling analysis before the results come back.

“Of course, if this ever becomes clinically proven, I’m sure the turnaround time would become very quick,” according to the cardiologist.

A cost-effectiveness analysis of FFR-CT versus current standard care is ongoing and the results aren’t yet available. However, Dr. Curzen observed, “The cost to the patient is a very important issue: Who would want to have this done invasively if you have a test that proves you don’t need to have an invasive procedure?”

The FFR-CT RIPCORD study was sponsored by Heartflow. Dr. Curzen reported receiving research support from Heartflow, Boston Scientific, Haemonetics, and Medtronic.

[email protected]

NEW YORK – A simplified surgical approach that uses an adult-sized, basic ring annuloplasty with a complete edge-to-edge leaflet repair has been found to yield good outcomes in a group of children with connective tissue disorders like Marfan syndrome and Loeys-Dietz syndrome and mitral regurgitation, based on an evaluation of the technique at four centers.

Cardiac surgeons employed the simplified operation in 18 patients under age 18 (median age 8.2 years) and found that after 2.4 years of follow-up, no patients required another operation for mitral regurgitation, reported Dr. Luca Vricella, pediatrics director, pediatric cardiac surgery and heart transplantation, John Hopkins University, Baltimore.

The patients underwent the simplified mitral valve repair at Johns Hopkins Pediatric Cardiac Surgery in Baltimore and Orlando; Duke University School of Medicine in Durham, N.C.; and University of Pavia Medical School in Italy.

These young patients can be challenging to operate on because of skeletal abnormalities and marginal pulmonary reserve, Dr. Vricella said at the meeting sponsored by the American Association for Thoracic Surgery. Of the 18 children in the study, 15 had Marfan syndrome, a genetic disorder that commonly affects the heart valves and aorta. “The most common mode of early presentation of mitral valve pathology, from a morphological standpoint, is that mitral regurgitation is often characterized as severe bileaflet prolapse and annular and left ventricular dilation,” Dr. Vricella said.

The simplified technique involves an approach through an atriotomy and placing an adult-sized annuloplasty ring in the valve. The next step is to place an Alfieri stitch, named for the Italian cardiac surgeon Dr. Ottavio Alfieri, with a braided suture in the middle of the valve, which opposes the leaflet “very effectively,” Dr. Vricella said.

In the study group, all 18 patients had severe bileaflet prolapse and severe mitral regurgitation of grade 4 or higher, but all patients also had normal ejection fraction, Dr. Vricella said. One infant was being considered for a heart transplant.

The operation was achieved in isolation in less than an hour. Five patients underwent simultaneous valve-sparing aortic root replacement, one of whom died (one of two deaths in a larger 300-plus group of both adults and children who had valve-sparing aortic root repair). No other complications were reported among the 18-patient group. Median length of stay in the hospital was 9 days.

After the operation, all patients had significant reductions in mitral regurgitation. After 2.4 years, 94% of survivors maintained mild regurgitation or better without stenosis. Entering the study, the median left ventricular end-diastolic diameter (LVEDD) score of all patients was 4.9 (range 2.1-11.9), but at 2.4 years after the operation the median LVEDD score had regressed to 1.3 (range –0.51-4.3).

“In pediatric patients with severe mitral regurgitation and connective tissue disorders, a simplified repair can result in intermediate-term competency without systolic anterior motion and with no mitral stenosis,” Dr. Vricella said. “We’ve been pleasantly surprised in seeing this reduction in left ventricular enlargement, and particularly in this group of patients in which you may need to have a longer plant time, simplifying things so you don’t have to intervene on the subvalvular annuloplasty.”

NEW YORK – A simplified surgical approach that uses an adult-sized, basic ring annuloplasty with a complete edge-to-edge leaflet repair has been found to yield good outcomes in a group of children with connective tissue disorders like Marfan syndrome and Loeys-Dietz syndrome and mitral regurgitation, based on an evaluation of the technique at four centers.

Cardiac surgeons employed the simplified operation in 18 patients under age 18 (median age 8.2 years) and found that after 2.4 years of follow-up, no patients required another operation for mitral regurgitation, reported Dr. Luca Vricella, pediatrics director, pediatric cardiac surgery and heart transplantation, John Hopkins University, Baltimore.

The patients underwent the simplified mitral valve repair at Johns Hopkins Pediatric Cardiac Surgery in Baltimore and Orlando; Duke University School of Medicine in Durham, N.C.; and University of Pavia Medical School in Italy.

These young patients can be challenging to operate on because of skeletal abnormalities and marginal pulmonary reserve, Dr. Vricella said at the meeting sponsored by the American Association for Thoracic Surgery. Of the 18 children in the study, 15 had Marfan syndrome, a genetic disorder that commonly affects the heart valves and aorta. “The most common mode of early presentation of mitral valve pathology, from a morphological standpoint, is that mitral regurgitation is often characterized as severe bileaflet prolapse and annular and left ventricular dilation,” Dr. Vricella said.

The simplified technique involves an approach through an atriotomy and placing an adult-sized annuloplasty ring in the valve. The next step is to place an Alfieri stitch, named for the Italian cardiac surgeon Dr. Ottavio Alfieri, with a braided suture in the middle of the valve, which opposes the leaflet “very effectively,” Dr. Vricella said.

In the study group, all 18 patients had severe bileaflet prolapse and severe mitral regurgitation of grade 4 or higher, but all patients also had normal ejection fraction, Dr. Vricella said. One infant was being considered for a heart transplant.

The operation was achieved in isolation in less than an hour. Five patients underwent simultaneous valve-sparing aortic root replacement, one of whom died (one of two deaths in a larger 300-plus group of both adults and children who had valve-sparing aortic root repair). No other complications were reported among the 18-patient group. Median length of stay in the hospital was 9 days.

After the operation, all patients had significant reductions in mitral regurgitation. After 2.4 years, 94% of survivors maintained mild regurgitation or better without stenosis. Entering the study, the median left ventricular end-diastolic diameter (LVEDD) score of all patients was 4.9 (range 2.1-11.9), but at 2.4 years after the operation the median LVEDD score had regressed to 1.3 (range –0.51-4.3).

“In pediatric patients with severe mitral regurgitation and connective tissue disorders, a simplified repair can result in intermediate-term competency without systolic anterior motion and with no mitral stenosis,” Dr. Vricella said. “We’ve been pleasantly surprised in seeing this reduction in left ventricular enlargement, and particularly in this group of patients in which you may need to have a longer plant time, simplifying things so you don’t have to intervene on the subvalvular annuloplasty.”

NEW YORK – A simplified surgical approach that uses an adult-sized, basic ring annuloplasty with a complete edge-to-edge leaflet repair has been found to yield good outcomes in a group of children with connective tissue disorders like Marfan syndrome and Loeys-Dietz syndrome and mitral regurgitation, based on an evaluation of the technique at four centers.

Cardiac surgeons employed the simplified operation in 18 patients under age 18 (median age 8.2 years) and found that after 2.4 years of follow-up, no patients required another operation for mitral regurgitation, reported Dr. Luca Vricella, pediatrics director, pediatric cardiac surgery and heart transplantation, John Hopkins University, Baltimore.

The patients underwent the simplified mitral valve repair at Johns Hopkins Pediatric Cardiac Surgery in Baltimore and Orlando; Duke University School of Medicine in Durham, N.C.; and University of Pavia Medical School in Italy.

These young patients can be challenging to operate on because of skeletal abnormalities and marginal pulmonary reserve, Dr. Vricella said at the meeting sponsored by the American Association for Thoracic Surgery. Of the 18 children in the study, 15 had Marfan syndrome, a genetic disorder that commonly affects the heart valves and aorta. “The most common mode of early presentation of mitral valve pathology, from a morphological standpoint, is that mitral regurgitation is often characterized as severe bileaflet prolapse and annular and left ventricular dilation,” Dr. Vricella said.

The simplified technique involves an approach through an atriotomy and placing an adult-sized annuloplasty ring in the valve. The next step is to place an Alfieri stitch, named for the Italian cardiac surgeon Dr. Ottavio Alfieri, with a braided suture in the middle of the valve, which opposes the leaflet “very effectively,” Dr. Vricella said.

In the study group, all 18 patients had severe bileaflet prolapse and severe mitral regurgitation of grade 4 or higher, but all patients also had normal ejection fraction, Dr. Vricella said. One infant was being considered for a heart transplant.

The operation was achieved in isolation in less than an hour. Five patients underwent simultaneous valve-sparing aortic root replacement, one of whom died (one of two deaths in a larger 300-plus group of both adults and children who had valve-sparing aortic root repair). No other complications were reported among the 18-patient group. Median length of stay in the hospital was 9 days.

After the operation, all patients had significant reductions in mitral regurgitation. After 2.4 years, 94% of survivors maintained mild regurgitation or better without stenosis. Entering the study, the median left ventricular end-diastolic diameter (LVEDD) score of all patients was 4.9 (range 2.1-11.9), but at 2.4 years after the operation the median LVEDD score had regressed to 1.3 (range –0.51-4.3).

“In pediatric patients with severe mitral regurgitation and connective tissue disorders, a simplified repair can result in intermediate-term competency without systolic anterior motion and with no mitral stenosis,” Dr. Vricella said. “We’ve been pleasantly surprised in seeing this reduction in left ventricular enlargement, and particularly in this group of patients in which you may need to have a longer plant time, simplifying things so you don’t have to intervene on the subvalvular annuloplasty.”

Since the debut of drug-eluting stents, more high-risk patient groups, namely diabetic patients, have undergone coronary stenting as opposed to coronary artery bypass grafting (CABG) as an option to open blocked arteries; however, diabetic patients with stents who go on to have CABG have significantly higher 5-year death rates than do unstented diabetics who undergo CABG, according to a study published in the May issue of the Journal of Thoracic and Cardiovascular Surgery.

A review of 7,005 CABG procedures performed from 1996 to 2007 at Mercy St. Vincent Medical Center in Toledo, Ohio, found that diabetic patients with triple-vessel disease and a prior percutaneous coronary intervention with stenting (PCI-S) who underwent CABG had a 39% greater risk of death within 5 years of the operation. The findings are significant, according to Dr. Victor Nauffal and his colleagues at the American University of Beirut, because increasing numbers of patients with coronary stents are referred for CABG (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.01.051).

Previous studies have linked prior stenting to an increased risk of bleeding and stent thrombosis during CABG, so having a better understanding of anticoagulation during the operation and the timing of the surgery after stenting could decrease complications. Investigations of the long-term outcomes of patients with stents who have CABG, however, have been lacking. This study investigated the premise that diabetics with triple-vessel disease and a stent had poorer outcomes because of endothelial dysfunction and the increased strain that triple-vessel disease places on the heart.

After exclusions, the final study population comprised 1,583 diabetic patients with concomitant triple-vessel disease, 202 (12.8%) of whom had coronary stents. The study defined triple-vessel disease as blockages of 50% or more in all three native coronary vessels or left main artery plus right coronary artery disease.

Early mortality rates – death within 30 days of the procedure – were similar between the two groups: 3.3% overall, 3% in the prior-PCI group, and 3.3% in the no-PCI group; therefore, prior PCI was not a predictor of early mortality.

Five-year cumulative survival was 78.5% in the no-PCI group, compared with 74.8% in the PCI group. When adjusting for a variety of clinical variables before CABG, stenting was associated with a 39% greater mortality at 5 years. The investigators accounted for the emergence of drug-eluting stents during the 10-year study period but found that they did not contribute significantly to overall outcomes.

The cause of death was known for 81.7% (282 of 345) of the deaths in the overall cohort, with 5-year cardiac deaths higher in the PCI-S group: 8.4% vs. 7.5% for the no-PCI group. “Notably, 100% of PCI-S cardiac mortality was categorized as coronary heart disease related compared to 89.3% (92/103) of cardiac mortality in the no-PCI group,” Dr. Nauffal and his associates said.

Careful patient selection for CABG is in order for diabetics with triple-vessel disease, particularly those with a prior stent, the authors advised. “An early team-based approach including a cardiologist and cardiac surgeon should be implemented for optimal revascularization strategy selection in diabetics with triple-vessel disease and for close medical follow-up of those higher risk CABG patients with history of intracoronary stents,” Dr. Nauffal and his colleagues concluded.

The Johns Hopkins Murex Research Award supported Dr. Nauffal. The authors had no other relevant disclosures.

Since the debut of drug-eluting stents, more high-risk patient groups, namely diabetic patients, have undergone coronary stenting as opposed to coronary artery bypass grafting (CABG) as an option to open blocked arteries; however, diabetic patients with stents who go on to have CABG have significantly higher 5-year death rates than do unstented diabetics who undergo CABG, according to a study published in the May issue of the Journal of Thoracic and Cardiovascular Surgery.

A review of 7,005 CABG procedures performed from 1996 to 2007 at Mercy St. Vincent Medical Center in Toledo, Ohio, found that diabetic patients with triple-vessel disease and a prior percutaneous coronary intervention with stenting (PCI-S) who underwent CABG had a 39% greater risk of death within 5 years of the operation. The findings are significant, according to Dr. Victor Nauffal and his colleagues at the American University of Beirut, because increasing numbers of patients with coronary stents are referred for CABG (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.01.051).

Previous studies have linked prior stenting to an increased risk of bleeding and stent thrombosis during CABG, so having a better understanding of anticoagulation during the operation and the timing of the surgery after stenting could decrease complications. Investigations of the long-term outcomes of patients with stents who have CABG, however, have been lacking. This study investigated the premise that diabetics with triple-vessel disease and a stent had poorer outcomes because of endothelial dysfunction and the increased strain that triple-vessel disease places on the heart.

After exclusions, the final study population comprised 1,583 diabetic patients with concomitant triple-vessel disease, 202 (12.8%) of whom had coronary stents. The study defined triple-vessel disease as blockages of 50% or more in all three native coronary vessels or left main artery plus right coronary artery disease.

Early mortality rates – death within 30 days of the procedure – were similar between the two groups: 3.3% overall, 3% in the prior-PCI group, and 3.3% in the no-PCI group; therefore, prior PCI was not a predictor of early mortality.

Five-year cumulative survival was 78.5% in the no-PCI group, compared with 74.8% in the PCI group. When adjusting for a variety of clinical variables before CABG, stenting was associated with a 39% greater mortality at 5 years. The investigators accounted for the emergence of drug-eluting stents during the 10-year study period but found that they did not contribute significantly to overall outcomes.

The cause of death was known for 81.7% (282 of 345) of the deaths in the overall cohort, with 5-year cardiac deaths higher in the PCI-S group: 8.4% vs. 7.5% for the no-PCI group. “Notably, 100% of PCI-S cardiac mortality was categorized as coronary heart disease related compared to 89.3% (92/103) of cardiac mortality in the no-PCI group,” Dr. Nauffal and his associates said.

Careful patient selection for CABG is in order for diabetics with triple-vessel disease, particularly those with a prior stent, the authors advised. “An early team-based approach including a cardiologist and cardiac surgeon should be implemented for optimal revascularization strategy selection in diabetics with triple-vessel disease and for close medical follow-up of those higher risk CABG patients with history of intracoronary stents,” Dr. Nauffal and his colleagues concluded.

The Johns Hopkins Murex Research Award supported Dr. Nauffal. The authors had no other relevant disclosures.

Since the debut of drug-eluting stents, more high-risk patient groups, namely diabetic patients, have undergone coronary stenting as opposed to coronary artery bypass grafting (CABG) as an option to open blocked arteries; however, diabetic patients with stents who go on to have CABG have significantly higher 5-year death rates than do unstented diabetics who undergo CABG, according to a study published in the May issue of the Journal of Thoracic and Cardiovascular Surgery.

A review of 7,005 CABG procedures performed from 1996 to 2007 at Mercy St. Vincent Medical Center in Toledo, Ohio, found that diabetic patients with triple-vessel disease and a prior percutaneous coronary intervention with stenting (PCI-S) who underwent CABG had a 39% greater risk of death within 5 years of the operation. The findings are significant, according to Dr. Victor Nauffal and his colleagues at the American University of Beirut, because increasing numbers of patients with coronary stents are referred for CABG (J. Thorac. Cardiovasc. Surg. 2015 [doi:10.1016/j.jtcvs.2015.01.051).

Previous studies have linked prior stenting to an increased risk of bleeding and stent thrombosis during CABG, so having a better understanding of anticoagulation during the operation and the timing of the surgery after stenting could decrease complications. Investigations of the long-term outcomes of patients with stents who have CABG, however, have been lacking. This study investigated the premise that diabetics with triple-vessel disease and a stent had poorer outcomes because of endothelial dysfunction and the increased strain that triple-vessel disease places on the heart.

After exclusions, the final study population comprised 1,583 diabetic patients with concomitant triple-vessel disease, 202 (12.8%) of whom had coronary stents. The study defined triple-vessel disease as blockages of 50% or more in all three native coronary vessels or left main artery plus right coronary artery disease.

Early mortality rates – death within 30 days of the procedure – were similar between the two groups: 3.3% overall, 3% in the prior-PCI group, and 3.3% in the no-PCI group; therefore, prior PCI was not a predictor of early mortality.

Five-year cumulative survival was 78.5% in the no-PCI group, compared with 74.8% in the PCI group. When adjusting for a variety of clinical variables before CABG, stenting was associated with a 39% greater mortality at 5 years. The investigators accounted for the emergence of drug-eluting stents during the 10-year study period but found that they did not contribute significantly to overall outcomes.

The cause of death was known for 81.7% (282 of 345) of the deaths in the overall cohort, with 5-year cardiac deaths higher in the PCI-S group: 8.4% vs. 7.5% for the no-PCI group. “Notably, 100% of PCI-S cardiac mortality was categorized as coronary heart disease related compared to 89.3% (92/103) of cardiac mortality in the no-PCI group,” Dr. Nauffal and his associates said.

Careful patient selection for CABG is in order for diabetics with triple-vessel disease, particularly those with a prior stent, the authors advised. “An early team-based approach including a cardiologist and cardiac surgeon should be implemented for optimal revascularization strategy selection in diabetics with triple-vessel disease and for close medical follow-up of those higher risk CABG patients with history of intracoronary stents,” Dr. Nauffal and his colleagues concluded.

The Johns Hopkins Murex Research Award supported Dr. Nauffal. The authors had no other relevant disclosures.