Welcome to HM18 and Orlando! This is the annual conference’s first time in Orlando, a city dubbed “the happiest place on earth,” which conjures up magic and curiosity and brings out the kid in everyone. As Walt Disney noted, “Adults are only kids, grown up.” So we hope you have brought your sense of adventure and curiosity, as we have a lot planned for you!

Over the next 3 days, we invite you to network with nearly 5,000 hospitalist colleagues from around the “small world.” Introduce yourself to total strangers and discover you have a lot in common. This conference provides a wonderful opportunity to share best practices and discuss ideas.

Please have fun taking advantage of the wide array of learning opportunities the Annual Conference Committee developed for HM18. We hope the topics will grab your interest and pique your curiosity. We encourage you (and your inner kid) to try on new ideas, attend lectures that catch your eye, and roll up your sleeves to dive into interactive workshops. For extra fun, the committee created catchy Orlando-themed titles for many of the talks. We hope they make you smile!

The Annual Conference Committee members will be wearing large buttons to identify themselves. We welcome any feedback about the meeting. Please take the time to share your thoughts with us, and we are happy to help in any way. The committee members worked hard to create a pre-course day and meeting with something for everyone, knowing there is great diversity under the hospitalist tent. We also strove to make it relevant and timely. The driving force behind the content was “What do practicing hospitalists need and want to know now?”

HM18 contains an abundance of clinical content. Enjoy the 2 days of Clinical Update talks to hear the latest evidence from a diversity of fields. New this year is Updates in Addiction Medicine, given the large opioid crisis that affecting health care. There are 3 days of Rapid Fire talks to answer the clinical questions we all have while caring for patients. The Perioperative/Co-Management track is back with is unique and useful content. We even repeat some of the most popular talks on Tuesday, so you will be able to attend all the “can’t miss” sessions.

New this year is a focus on careers and how to make yours enjoyable and sustainable. Hospital medicine is more than 20 years old, and there are increasing numbers of mid-career hospitalists. The Career Development track offers a series of topics in case you want to spice up your current role, change your schedule, or plan for retirement. Accompanying this are career development workshops that provide practical skills to do just that.

We have also added a new NP/PA track, a palliative care track, and The Great Debate track. Come watch two entertaining speakers have a “smackdown” on a clinical topic. You’ll learn something while laughing.

This conference would not be possible without the tireless effort of SHM staff and leadership, our amazing speakers and faculty, and the committee members. We are excited you are here, and we hope this conference nurtures your curiosity, expands your career, and provides you with valuable educational and networking opportunities.

We sincerely thank you for attending HM18! Enjoy Orlando.

Dr. Finn is an assistant professor of medicine at Harvard Medical School, Boston, and course director of HM18.

Welcome to HM18 and Orlando! This is the annual conference’s first time in Orlando, a city dubbed “the happiest place on earth,” which conjures up magic and curiosity and brings out the kid in everyone. As Walt Disney noted, “Adults are only kids, grown up.” So we hope you have brought your sense of adventure and curiosity, as we have a lot planned for you!

Over the next 3 days, we invite you to network with nearly 5,000 hospitalist colleagues from around the “small world.” Introduce yourself to total strangers and discover you have a lot in common. This conference provides a wonderful opportunity to share best practices and discuss ideas.

Please have fun taking advantage of the wide array of learning opportunities the Annual Conference Committee developed for HM18. We hope the topics will grab your interest and pique your curiosity. We encourage you (and your inner kid) to try on new ideas, attend lectures that catch your eye, and roll up your sleeves to dive into interactive workshops. For extra fun, the committee created catchy Orlando-themed titles for many of the talks. We hope they make you smile!

The Annual Conference Committee members will be wearing large buttons to identify themselves. We welcome any feedback about the meeting. Please take the time to share your thoughts with us, and we are happy to help in any way. The committee members worked hard to create a pre-course day and meeting with something for everyone, knowing there is great diversity under the hospitalist tent. We also strove to make it relevant and timely. The driving force behind the content was “What do practicing hospitalists need and want to know now?”

HM18 contains an abundance of clinical content. Enjoy the 2 days of Clinical Update talks to hear the latest evidence from a diversity of fields. New this year is Updates in Addiction Medicine, given the large opioid crisis that affecting health care. There are 3 days of Rapid Fire talks to answer the clinical questions we all have while caring for patients. The Perioperative/Co-Management track is back with is unique and useful content. We even repeat some of the most popular talks on Tuesday, so you will be able to attend all the “can’t miss” sessions.

New this year is a focus on careers and how to make yours enjoyable and sustainable. Hospital medicine is more than 20 years old, and there are increasing numbers of mid-career hospitalists. The Career Development track offers a series of topics in case you want to spice up your current role, change your schedule, or plan for retirement. Accompanying this are career development workshops that provide practical skills to do just that.

We have also added a new NP/PA track, a palliative care track, and The Great Debate track. Come watch two entertaining speakers have a “smackdown” on a clinical topic. You’ll learn something while laughing.

This conference would not be possible without the tireless effort of SHM staff and leadership, our amazing speakers and faculty, and the committee members. We are excited you are here, and we hope this conference nurtures your curiosity, expands your career, and provides you with valuable educational and networking opportunities.

We sincerely thank you for attending HM18! Enjoy Orlando.

Dr. Finn is an assistant professor of medicine at Harvard Medical School, Boston, and course director of HM18.

Welcome to HM18 and Orlando! This is the annual conference’s first time in Orlando, a city dubbed “the happiest place on earth,” which conjures up magic and curiosity and brings out the kid in everyone. As Walt Disney noted, “Adults are only kids, grown up.” So we hope you have brought your sense of adventure and curiosity, as we have a lot planned for you!

Over the next 3 days, we invite you to network with nearly 5,000 hospitalist colleagues from around the “small world.” Introduce yourself to total strangers and discover you have a lot in common. This conference provides a wonderful opportunity to share best practices and discuss ideas.

Please have fun taking advantage of the wide array of learning opportunities the Annual Conference Committee developed for HM18. We hope the topics will grab your interest and pique your curiosity. We encourage you (and your inner kid) to try on new ideas, attend lectures that catch your eye, and roll up your sleeves to dive into interactive workshops. For extra fun, the committee created catchy Orlando-themed titles for many of the talks. We hope they make you smile!

The Annual Conference Committee members will be wearing large buttons to identify themselves. We welcome any feedback about the meeting. Please take the time to share your thoughts with us, and we are happy to help in any way. The committee members worked hard to create a pre-course day and meeting with something for everyone, knowing there is great diversity under the hospitalist tent. We also strove to make it relevant and timely. The driving force behind the content was “What do practicing hospitalists need and want to know now?”

HM18 contains an abundance of clinical content. Enjoy the 2 days of Clinical Update talks to hear the latest evidence from a diversity of fields. New this year is Updates in Addiction Medicine, given the large opioid crisis that affecting health care. There are 3 days of Rapid Fire talks to answer the clinical questions we all have while caring for patients. The Perioperative/Co-Management track is back with is unique and useful content. We even repeat some of the most popular talks on Tuesday, so you will be able to attend all the “can’t miss” sessions.

New this year is a focus on careers and how to make yours enjoyable and sustainable. Hospital medicine is more than 20 years old, and there are increasing numbers of mid-career hospitalists. The Career Development track offers a series of topics in case you want to spice up your current role, change your schedule, or plan for retirement. Accompanying this are career development workshops that provide practical skills to do just that.

We have also added a new NP/PA track, a palliative care track, and The Great Debate track. Come watch two entertaining speakers have a “smackdown” on a clinical topic. You’ll learn something while laughing.

This conference would not be possible without the tireless effort of SHM staff and leadership, our amazing speakers and faculty, and the committee members. We are excited you are here, and we hope this conference nurtures your curiosity, expands your career, and provides you with valuable educational and networking opportunities.

We sincerely thank you for attending HM18! Enjoy Orlando.

Dr. Finn is an assistant professor of medicine at Harvard Medical School, Boston, and course director of HM18.

Over the past several years, the Society of Hospital Medicine has become more involved in developing global relationships in an attempt to become a resource for hospital medicine movements in other countries. As part of this initiative, HM18 will host an International Lounge on Tuesday, April 10, from 10 a.m. to 3 p.m. in the Anaheim Room at the Orlando Marriott World Center.

“SHM has been taking a more deliberate approach to cultivating international relationships,” said Ethan Gray, CAE, vice president of membership for the society. “Although we are still in the beginning phases of establishing a global footprint that will provide enduring resources that respond to the needs of international members similar to those we provide to our U.S. members, we are making efforts toward that end.”

The International Lounge at HM18 is one such effort. Its purpose is to provide worldwide attendees with enhanced networking opportunities, information on how to launch an SHM chapter, and the opportunity to interact with SHM staff and board leaders.

“On Monday, HM18 will be hosting an International Special Interest Forum, which will allow global participants to share their experiences and interact with thought leaders from the United States and abroad, including SHM board members,” continued Mr. Gray. “The International Lounge is an extension of our global outreach at the annual meeting.”

The International Lounge will offer informal networking. As the SHM staff liaison, Mr. Gray will be on hand to answer any questions from and interact with global attendees. SHM board members also will be available on a rotating schedule throughout the day to network, dialogue, and share their knowledge and expertise.

As SHM expands its international activities, it is dedicating staff resources at its Philadelphia headquarters to international chapter development, including facilitating virtual communities on its Hospital Medical Exchange (HMX).

“Those visiting the lounge will be able to pick up a written fact sheet on the elements needed to create an SHM chapter,” stated Mr. Gray. “And, I will be available to discuss chapter launch requisites and any other questions they might have.”

International Lounge
Tuesday, April 10, 10 a.m.-3 p.m.
Anaheim Room

Over the past several years, the Society of Hospital Medicine has become more involved in developing global relationships in an attempt to become a resource for hospital medicine movements in other countries. As part of this initiative, HM18 will host an International Lounge on Tuesday, April 10, from 10 a.m. to 3 p.m. in the Anaheim Room at the Orlando Marriott World Center.

“SHM has been taking a more deliberate approach to cultivating international relationships,” said Ethan Gray, CAE, vice president of membership for the society. “Although we are still in the beginning phases of establishing a global footprint that will provide enduring resources that respond to the needs of international members similar to those we provide to our U.S. members, we are making efforts toward that end.”

The International Lounge at HM18 is one such effort. Its purpose is to provide worldwide attendees with enhanced networking opportunities, information on how to launch an SHM chapter, and the opportunity to interact with SHM staff and board leaders.

“On Monday, HM18 will be hosting an International Special Interest Forum, which will allow global participants to share their experiences and interact with thought leaders from the United States and abroad, including SHM board members,” continued Mr. Gray. “The International Lounge is an extension of our global outreach at the annual meeting.”

The International Lounge will offer informal networking. As the SHM staff liaison, Mr. Gray will be on hand to answer any questions from and interact with global attendees. SHM board members also will be available on a rotating schedule throughout the day to network, dialogue, and share their knowledge and expertise.

As SHM expands its international activities, it is dedicating staff resources at its Philadelphia headquarters to international chapter development, including facilitating virtual communities on its Hospital Medical Exchange (HMX).

“Those visiting the lounge will be able to pick up a written fact sheet on the elements needed to create an SHM chapter,” stated Mr. Gray. “And, I will be available to discuss chapter launch requisites and any other questions they might have.”

International Lounge
Tuesday, April 10, 10 a.m.-3 p.m.
Anaheim Room

Over the past several years, the Society of Hospital Medicine has become more involved in developing global relationships in an attempt to become a resource for hospital medicine movements in other countries. As part of this initiative, HM18 will host an International Lounge on Tuesday, April 10, from 10 a.m. to 3 p.m. in the Anaheim Room at the Orlando Marriott World Center.

“SHM has been taking a more deliberate approach to cultivating international relationships,” said Ethan Gray, CAE, vice president of membership for the society. “Although we are still in the beginning phases of establishing a global footprint that will provide enduring resources that respond to the needs of international members similar to those we provide to our U.S. members, we are making efforts toward that end.”

The International Lounge at HM18 is one such effort. Its purpose is to provide worldwide attendees with enhanced networking opportunities, information on how to launch an SHM chapter, and the opportunity to interact with SHM staff and board leaders.

“On Monday, HM18 will be hosting an International Special Interest Forum, which will allow global participants to share their experiences and interact with thought leaders from the United States and abroad, including SHM board members,” continued Mr. Gray. “The International Lounge is an extension of our global outreach at the annual meeting.”

The International Lounge will offer informal networking. As the SHM staff liaison, Mr. Gray will be on hand to answer any questions from and interact with global attendees. SHM board members also will be available on a rotating schedule throughout the day to network, dialogue, and share their knowledge and expertise.

As SHM expands its international activities, it is dedicating staff resources at its Philadelphia headquarters to international chapter development, including facilitating virtual communities on its Hospital Medical Exchange (HMX).

“Those visiting the lounge will be able to pick up a written fact sheet on the elements needed to create an SHM chapter,” stated Mr. Gray. “And, I will be available to discuss chapter launch requisites and any other questions they might have.”

International Lounge
Tuesday, April 10, 10 a.m.-3 p.m.
Anaheim Room

The Resident and Student Luncheon provides future hospitalists the opportunity to meet current hospitalists and learn about various fields within hospital medicine.

“Trainees can ask hospitalists who are administrative leaders, QI gurus, medical educators, global health hospitalists, pediatricians, and researchers about their day-to-day life and what they love about their careers,” stated Darlene B. Tad-y, MD, SFHM, who is an associate professor and hospitalist at the University of Colorado Hospital, Denver. “It’s a great way for trainees to build their network in hospital medicine in addition to learning about the diverse careers available in our field.”

The luncheon is structured in such a way to maximizes attendees’ exposure and interaction with experienced hospitalists. Brian Kwan, MD, FHM, an associate professor of health science at the University of California, San Diego, and a hospitalist, elaborated on the sessions design.

“Each round table features a speaker that will highlight a different topic, including but not limited to medical education, executive leadership, global and rural health, quality improvement, advocacy, and informatics,” said Dr. Kwan.

But the session is not limited to a one-way presentation. “Conversations are facilitated by members of the SHM Physicians in Training (PIT) Committee,” he said. To maximize their exposure, “attendees will have an opportunity to select one table for the main meal and a different one for dessert, so that they have the opportunity to hear from more than one speaker.”

Dr. Kwan and Dr. Tad-y said they believe that this type of exposure is important in the professional development of medical students and residents.

“We believe it is critical for students and residents to be exposed to hospitalists working at the forefront of our field who inspire and can provide a glimpse at different HM career paths and practices. Invited speakers are selected by the PIT Committee, and the luncheon serves as a launching point for networking and potential mentorship. Engaging residents and students is critical to sustaining our pipeline for future hospitalist leaders,” Dr. Kwan said.

Dr. Tad-y stated that this could be a defining professional moment for many of the attendees. “The resident or student may even meet their next project or career mentor, as well as potential peers or project partners.”

Resident and Student Luncheon
April 9, Monday, 12-1 p.m.
New York/New Orleans Room

The Resident and Student Luncheon provides future hospitalists the opportunity to meet current hospitalists and learn about various fields within hospital medicine.

“Trainees can ask hospitalists who are administrative leaders, QI gurus, medical educators, global health hospitalists, pediatricians, and researchers about their day-to-day life and what they love about their careers,” stated Darlene B. Tad-y, MD, SFHM, who is an associate professor and hospitalist at the University of Colorado Hospital, Denver. “It’s a great way for trainees to build their network in hospital medicine in addition to learning about the diverse careers available in our field.”

The luncheon is structured in such a way to maximizes attendees’ exposure and interaction with experienced hospitalists. Brian Kwan, MD, FHM, an associate professor of health science at the University of California, San Diego, and a hospitalist, elaborated on the sessions design.

“Each round table features a speaker that will highlight a different topic, including but not limited to medical education, executive leadership, global and rural health, quality improvement, advocacy, and informatics,” said Dr. Kwan.

But the session is not limited to a one-way presentation. “Conversations are facilitated by members of the SHM Physicians in Training (PIT) Committee,” he said. To maximize their exposure, “attendees will have an opportunity to select one table for the main meal and a different one for dessert, so that they have the opportunity to hear from more than one speaker.”

Dr. Kwan and Dr. Tad-y said they believe that this type of exposure is important in the professional development of medical students and residents.

“We believe it is critical for students and residents to be exposed to hospitalists working at the forefront of our field who inspire and can provide a glimpse at different HM career paths and practices. Invited speakers are selected by the PIT Committee, and the luncheon serves as a launching point for networking and potential mentorship. Engaging residents and students is critical to sustaining our pipeline for future hospitalist leaders,” Dr. Kwan said.

Dr. Tad-y stated that this could be a defining professional moment for many of the attendees. “The resident or student may even meet their next project or career mentor, as well as potential peers or project partners.”

Resident and Student Luncheon
April 9, Monday, 12-1 p.m.
New York/New Orleans Room

The Resident and Student Luncheon provides future hospitalists the opportunity to meet current hospitalists and learn about various fields within hospital medicine.

“Trainees can ask hospitalists who are administrative leaders, QI gurus, medical educators, global health hospitalists, pediatricians, and researchers about their day-to-day life and what they love about their careers,” stated Darlene B. Tad-y, MD, SFHM, who is an associate professor and hospitalist at the University of Colorado Hospital, Denver. “It’s a great way for trainees to build their network in hospital medicine in addition to learning about the diverse careers available in our field.”

The luncheon is structured in such a way to maximizes attendees’ exposure and interaction with experienced hospitalists. Brian Kwan, MD, FHM, an associate professor of health science at the University of California, San Diego, and a hospitalist, elaborated on the sessions design.

“Each round table features a speaker that will highlight a different topic, including but not limited to medical education, executive leadership, global and rural health, quality improvement, advocacy, and informatics,” said Dr. Kwan.

But the session is not limited to a one-way presentation. “Conversations are facilitated by members of the SHM Physicians in Training (PIT) Committee,” he said. To maximize their exposure, “attendees will have an opportunity to select one table for the main meal and a different one for dessert, so that they have the opportunity to hear from more than one speaker.”

Dr. Kwan and Dr. Tad-y said they believe that this type of exposure is important in the professional development of medical students and residents.

“We believe it is critical for students and residents to be exposed to hospitalists working at the forefront of our field who inspire and can provide a glimpse at different HM career paths and practices. Invited speakers are selected by the PIT Committee, and the luncheon serves as a launching point for networking and potential mentorship. Engaging residents and students is critical to sustaining our pipeline for future hospitalist leaders,” Dr. Kwan said.

Dr. Tad-y stated that this could be a defining professional moment for many of the attendees. “The resident or student may even meet their next project or career mentor, as well as potential peers or project partners.”

Resident and Student Luncheon
April 9, Monday, 12-1 p.m.
New York/New Orleans Room

Chris Harrington knows that not all the benefits of attending the Society of Hospital Medicine’s annual meetings come from the lectures and courses; there is the formation of friendships that endure.

“I am very grateful to SHM for allowing me the opportunity to accompany Bob to their annual conferences and leadership academies over the years,” said Mrs. Harrington, spouse of former SHM president Robert Harrington Jr., MD, SFHM in an interview.

“It truly has been a rewarding experience for me both as a spouse to travel with my husband and spend time with our friends, and as a health care professional to witness the tremendous growth of SHM membership and the educational and networking opportunities it provides to its members. Watching SHM become even more innovative in universally improving patient care has been an amazing experience as well.

Chris Harrington knows that not all the benefits of attending the Society of Hospital Medicine’s annual meetings come from the lectures and courses; there is the formation of friendships that endure.

“I am very grateful to SHM for allowing me the opportunity to accompany Bob to their annual conferences and leadership academies over the years,” said Mrs. Harrington, spouse of former SHM president Robert Harrington Jr., MD, SFHM in an interview.

“It truly has been a rewarding experience for me both as a spouse to travel with my husband and spend time with our friends, and as a health care professional to witness the tremendous growth of SHM membership and the educational and networking opportunities it provides to its members. Watching SHM become even more innovative in universally improving patient care has been an amazing experience as well.

Chris Harrington knows that not all the benefits of attending the Society of Hospital Medicine’s annual meetings come from the lectures and courses; there is the formation of friendships that endure.

“I am very grateful to SHM for allowing me the opportunity to accompany Bob to their annual conferences and leadership academies over the years,” said Mrs. Harrington, spouse of former SHM president Robert Harrington Jr., MD, SFHM in an interview.

“It truly has been a rewarding experience for me both as a spouse to travel with my husband and spend time with our friends, and as a health care professional to witness the tremendous growth of SHM membership and the educational and networking opportunities it provides to its members. Watching SHM become even more innovative in universally improving patient care has been an amazing experience as well.

For women with ovarian cancer, an oncologist-led BRCA1/2 (BRCAm) counseling process is associated with favorable waiting times for test results and high levels of satisfaction, according to results of a prospective observational study.

The median turnaround time from initial counseling to receiving a test result was 9.1 weeks, investigators reported in the Journal of Clinical Oncology.

“Following a pathway similar to the one used in this study could allow faster treatment decisions and better use of resources in the management of patients with ovarian cancer,” said lead author Nicoletta Colombo, MD, of European Institute of Oncology, University of Milan-Bicocca, Italy, and her associates.

Establishing an ovarian cancer patient’s BRCAm status provides useful prognostic information and helps identify patients most likely to benefit from therapy with poly(ADP-ribose) polymerase (PARP) inhibitors, Dr. Colombo and her colleagues wrote.

However, despite guideline recommendations, many patients with an ovarian cancer diagnosis are currently not receiving BRCAm testing, they added.

“Given the high volume of BRCAm tests now being ordered, a new, more streamlined testing approach is needed to shorten testing turnaround times and to ease the pressure on genetic counselors,” the authors said.

In a pilot study from the United Kingdom, a streamlined, oncologist-led BRCAm testing model reduced a 20-week average turnaround time by fourfold, Dr. Colombo and her colleagues said.

[email protected]

SOURCE: Colombo N et al. J Clin Oncol. 2018 Mar 20. doi: 10.1200/JCO.2017.76.278.

For women with ovarian cancer, an oncologist-led BRCA1/2 (BRCAm) counseling process is associated with favorable waiting times for test results and high levels of satisfaction, according to results of a prospective observational study.

The median turnaround time from initial counseling to receiving a test result was 9.1 weeks, investigators reported in the Journal of Clinical Oncology.

“Following a pathway similar to the one used in this study could allow faster treatment decisions and better use of resources in the management of patients with ovarian cancer,” said lead author Nicoletta Colombo, MD, of European Institute of Oncology, University of Milan-Bicocca, Italy, and her associates.

Establishing an ovarian cancer patient’s BRCAm status provides useful prognostic information and helps identify patients most likely to benefit from therapy with poly(ADP-ribose) polymerase (PARP) inhibitors, Dr. Colombo and her colleagues wrote.

However, despite guideline recommendations, many patients with an ovarian cancer diagnosis are currently not receiving BRCAm testing, they added.

“Given the high volume of BRCAm tests now being ordered, a new, more streamlined testing approach is needed to shorten testing turnaround times and to ease the pressure on genetic counselors,” the authors said.

In a pilot study from the United Kingdom, a streamlined, oncologist-led BRCAm testing model reduced a 20-week average turnaround time by fourfold, Dr. Colombo and her colleagues said.

[email protected]

SOURCE: Colombo N et al. J Clin Oncol. 2018 Mar 20. doi: 10.1200/JCO.2017.76.278.

For women with ovarian cancer, an oncologist-led BRCA1/2 (BRCAm) counseling process is associated with favorable waiting times for test results and high levels of satisfaction, according to results of a prospective observational study.

The median turnaround time from initial counseling to receiving a test result was 9.1 weeks, investigators reported in the Journal of Clinical Oncology.

“Following a pathway similar to the one used in this study could allow faster treatment decisions and better use of resources in the management of patients with ovarian cancer,” said lead author Nicoletta Colombo, MD, of European Institute of Oncology, University of Milan-Bicocca, Italy, and her associates.

Establishing an ovarian cancer patient’s BRCAm status provides useful prognostic information and helps identify patients most likely to benefit from therapy with poly(ADP-ribose) polymerase (PARP) inhibitors, Dr. Colombo and her colleagues wrote.

However, despite guideline recommendations, many patients with an ovarian cancer diagnosis are currently not receiving BRCAm testing, they added.

“Given the high volume of BRCAm tests now being ordered, a new, more streamlined testing approach is needed to shorten testing turnaround times and to ease the pressure on genetic counselors,” the authors said.

In a pilot study from the United Kingdom, a streamlined, oncologist-led BRCAm testing model reduced a 20-week average turnaround time by fourfold, Dr. Colombo and her colleagues said.

[email protected]

SOURCE: Colombo N et al. J Clin Oncol. 2018 Mar 20. doi: 10.1200/JCO.2017.76.278.

In mantle cell lymphoma (MCL), ibrutinib plus venetoclax significantly improved the complete response rate, compared with what has been previously reported for ibrutinib alone, according to results of a phase 2 study.

Clinical outcomes with the combination seem superior to previously reported results for either treatment alone, said lead investigator Constantine S. Tam, MBBS, MD, of the Peter MacCallum Cancer Centre, Melbourne, and his coinvestigators.

“The results of our study, which used a historical cohort as a control, are consistent with the notion that the combination of ibrutinib and venetoclax is highly effective in mantle-cell lymphoma,” the investigators wrote in the New England Journal of Medicine.

The BTK inhibitor ibrutinib and the BCL2 inhibitor venetoclax are two of the most active agents for this B-cell cancer, investigators reported. The rationale for combining the agents is “compelling” because they affect different critical pathways in the malignant B cell.

Both agents have demonstrated complete response rates of 21% in previous studies of relapsed or refractory MCL, and preclinical studies suggest the combination of ibrutinib and venetoclax would be synergistic.

In the present single-group, phase 2 study, 24 patients with MCL (23 relapsed or refractory, 1 previously untreated) started ibrutinib 560 mg daily; at 4 weeks, venetoclax was started at a low dose and increased to 400 mg daily.

The study primary end point – complete response rate at week 16 assessed by CT – was 42%, compared with 9% for ibrutinib monotherapy in the phase 2 PCYC-1104-CA study (P less than .001).

Computed tomography assessment was used for the primary end point to allow comparison to the ibrutinib monotherapy study, which did not use positron emission tomography for restaging. “Our study was designed to have 80% power to reject a complete response rate of 9% (at a one-sided alpha level of 0.05) if the rate of complete response was at least 30%,” the investigators noted.

Complete response rate assessed by positron emission tomography at week 16 was 62%, and was 71% overall.

In all, 67% of patients had absence of minimal residual disease by flow cytometry. At 15 months, 78% of the responses were ongoing, and at 18 months, 57% of patients were alive and progression free.

“Such outcomes appear to be substantially better than those that have been reported for ibrutinib or venetoclax monotherapy,” the investigators wrote.

The combination had side effects that are “acceptable to both patients and physicians,” investigators wrote. Side effects, usually low grade, included diarrhea in 83% of patients, fatigue in 75%, and nausea or vomiting in 71%. Tumor lysis syndrome was seen in two patients.

Whether ibrutinib plus venetoclax is superior to ibrutinib alone is being formally evaluated in an ongoing phase 3 study.

Janssen and AbbVie partially funded the current phase 2 study. Dr. Tam reported financial ties to Janssen, AbbVie, and Pharmacyclics. Other study authors reported financial ties to various pharmaceutical companies.

SOURCE: Tam C et al. N Engl J Med. 2018;378:1211-23.

In mantle cell lymphoma (MCL), ibrutinib plus venetoclax significantly improved the complete response rate, compared with what has been previously reported for ibrutinib alone, according to results of a phase 2 study.

Clinical outcomes with the combination seem superior to previously reported results for either treatment alone, said lead investigator Constantine S. Tam, MBBS, MD, of the Peter MacCallum Cancer Centre, Melbourne, and his coinvestigators.

“The results of our study, which used a historical cohort as a control, are consistent with the notion that the combination of ibrutinib and venetoclax is highly effective in mantle-cell lymphoma,” the investigators wrote in the New England Journal of Medicine.

The BTK inhibitor ibrutinib and the BCL2 inhibitor venetoclax are two of the most active agents for this B-cell cancer, investigators reported. The rationale for combining the agents is “compelling” because they affect different critical pathways in the malignant B cell.

Both agents have demonstrated complete response rates of 21% in previous studies of relapsed or refractory MCL, and preclinical studies suggest the combination of ibrutinib and venetoclax would be synergistic.

In the present single-group, phase 2 study, 24 patients with MCL (23 relapsed or refractory, 1 previously untreated) started ibrutinib 560 mg daily; at 4 weeks, venetoclax was started at a low dose and increased to 400 mg daily.

The study primary end point – complete response rate at week 16 assessed by CT – was 42%, compared with 9% for ibrutinib monotherapy in the phase 2 PCYC-1104-CA study (P less than .001).

Computed tomography assessment was used for the primary end point to allow comparison to the ibrutinib monotherapy study, which did not use positron emission tomography for restaging. “Our study was designed to have 80% power to reject a complete response rate of 9% (at a one-sided alpha level of 0.05) if the rate of complete response was at least 30%,” the investigators noted.

Complete response rate assessed by positron emission tomography at week 16 was 62%, and was 71% overall.

In all, 67% of patients had absence of minimal residual disease by flow cytometry. At 15 months, 78% of the responses were ongoing, and at 18 months, 57% of patients were alive and progression free.

“Such outcomes appear to be substantially better than those that have been reported for ibrutinib or venetoclax monotherapy,” the investigators wrote.

The combination had side effects that are “acceptable to both patients and physicians,” investigators wrote. Side effects, usually low grade, included diarrhea in 83% of patients, fatigue in 75%, and nausea or vomiting in 71%. Tumor lysis syndrome was seen in two patients.

Whether ibrutinib plus venetoclax is superior to ibrutinib alone is being formally evaluated in an ongoing phase 3 study.

Janssen and AbbVie partially funded the current phase 2 study. Dr. Tam reported financial ties to Janssen, AbbVie, and Pharmacyclics. Other study authors reported financial ties to various pharmaceutical companies.

SOURCE: Tam C et al. N Engl J Med. 2018;378:1211-23.

In mantle cell lymphoma (MCL), ibrutinib plus venetoclax significantly improved the complete response rate, compared with what has been previously reported for ibrutinib alone, according to results of a phase 2 study.

Clinical outcomes with the combination seem superior to previously reported results for either treatment alone, said lead investigator Constantine S. Tam, MBBS, MD, of the Peter MacCallum Cancer Centre, Melbourne, and his coinvestigators.

“The results of our study, which used a historical cohort as a control, are consistent with the notion that the combination of ibrutinib and venetoclax is highly effective in mantle-cell lymphoma,” the investigators wrote in the New England Journal of Medicine.

The BTK inhibitor ibrutinib and the BCL2 inhibitor venetoclax are two of the most active agents for this B-cell cancer, investigators reported. The rationale for combining the agents is “compelling” because they affect different critical pathways in the malignant B cell.

Both agents have demonstrated complete response rates of 21% in previous studies of relapsed or refractory MCL, and preclinical studies suggest the combination of ibrutinib and venetoclax would be synergistic.

In the present single-group, phase 2 study, 24 patients with MCL (23 relapsed or refractory, 1 previously untreated) started ibrutinib 560 mg daily; at 4 weeks, venetoclax was started at a low dose and increased to 400 mg daily.

The study primary end point – complete response rate at week 16 assessed by CT – was 42%, compared with 9% for ibrutinib monotherapy in the phase 2 PCYC-1104-CA study (P less than .001).

Computed tomography assessment was used for the primary end point to allow comparison to the ibrutinib monotherapy study, which did not use positron emission tomography for restaging. “Our study was designed to have 80% power to reject a complete response rate of 9% (at a one-sided alpha level of 0.05) if the rate of complete response was at least 30%,” the investigators noted.

Complete response rate assessed by positron emission tomography at week 16 was 62%, and was 71% overall.

In all, 67% of patients had absence of minimal residual disease by flow cytometry. At 15 months, 78% of the responses were ongoing, and at 18 months, 57% of patients were alive and progression free.

“Such outcomes appear to be substantially better than those that have been reported for ibrutinib or venetoclax monotherapy,” the investigators wrote.

The combination had side effects that are “acceptable to both patients and physicians,” investigators wrote. Side effects, usually low grade, included diarrhea in 83% of patients, fatigue in 75%, and nausea or vomiting in 71%. Tumor lysis syndrome was seen in two patients.

Whether ibrutinib plus venetoclax is superior to ibrutinib alone is being formally evaluated in an ongoing phase 3 study.

Janssen and AbbVie partially funded the current phase 2 study. Dr. Tam reported financial ties to Janssen, AbbVie, and Pharmacyclics. Other study authors reported financial ties to various pharmaceutical companies.

SOURCE: Tam C et al. N Engl J Med. 2018;378:1211-23.

The gun control bill passed recently in Florida is a promising step forward in helping to protect children from deadly violence in schools. While various attempts to minimize gun violence have been stalled in state legislatures, in some cases for decades, this bill, which includes funding to expand mental health services for students, highlights a simple, sustainable, and nonpolitical solution: mental health providers.

Lisa Quarfoth/Thinkstock

Dr. Appel is director of the Montefiore School Health Program, which makes primary care, mental health, dental and vision services available to almost 40,000 K-12 students in 26 school-based health centers throughout the Bronx.

*This article was updated 3/29/2018.

The gun control bill passed recently in Florida is a promising step forward in helping to protect children from deadly violence in schools. While various attempts to minimize gun violence have been stalled in state legislatures, in some cases for decades, this bill, which includes funding to expand mental health services for students, highlights a simple, sustainable, and nonpolitical solution: mental health providers.

Lisa Quarfoth/Thinkstock

Dr. Appel is director of the Montefiore School Health Program, which makes primary care, mental health, dental and vision services available to almost 40,000 K-12 students in 26 school-based health centers throughout the Bronx.

*This article was updated 3/29/2018.

The gun control bill passed recently in Florida is a promising step forward in helping to protect children from deadly violence in schools. While various attempts to minimize gun violence have been stalled in state legislatures, in some cases for decades, this bill, which includes funding to expand mental health services for students, highlights a simple, sustainable, and nonpolitical solution: mental health providers.

Lisa Quarfoth/Thinkstock

Dr. Appel is director of the Montefiore School Health Program, which makes primary care, mental health, dental and vision services available to almost 40,000 K-12 students in 26 school-based health centers throughout the Bronx.

*This article was updated 3/29/2018.

“We should not consider marijuana ‘innocent until proven guilty,’ given what we already know about the harms to adolescents,”¹ Sharon Levy, MD, chair of the American Academy of Pediatrics Committee on Substance Abuse, said in an AAP press release, speaking of the legalization of marijuana in Washington and Colorado. The press release was issued in 2015 when the AAP updated its policy on the impact of marijuana policies on youth (Pediatrics. 2015. doi: 10.1542/peds.2014-4146), reaffirming its opposition to legalization of marijuana because it contended that limited studies had been done on “medical marijuana” in adults, and that there were no published studies either on the form of marijuana or other preparations that involved children.

Marijuana is a schedule I controlled substance, so the Food and Drug Administration does not regulate marijuana edibles, resulting in poor labeling and unregulated formulations.²

HighGradeRoots/Thinkstock

Marijuana overdoses can result in cognitive and motor impairment, extreme sedation, agitation, anxiety, cardiac stress, and vomiting. High quantities of THC have been reported to cause transient psychotic symptoms such as hallucinations, delusions, and anxiety.³

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at [email protected].

References

1. “American Academy of Pediatrics Reaffirms Opposition to Legalizing Marijuana for Recreational or Medical Use,” AAP press release on Jan. 26, 2015.

2. N Engl J Med. 2015;372:989-91.

3. Methods Rep RTI Press. 2016 Nov. doi: 10.3768/rtipress.2016.op.0035.1611.

4. JAMA. 2015;313(3):241-2.

5. Pediatrics. 2017 Mar;139(3):e20164069.

“We should not consider marijuana ‘innocent until proven guilty,’ given what we already know about the harms to adolescents,”¹ Sharon Levy, MD, chair of the American Academy of Pediatrics Committee on Substance Abuse, said in an AAP press release, speaking of the legalization of marijuana in Washington and Colorado. The press release was issued in 2015 when the AAP updated its policy on the impact of marijuana policies on youth (Pediatrics. 2015. doi: 10.1542/peds.2014-4146), reaffirming its opposition to legalization of marijuana because it contended that limited studies had been done on “medical marijuana” in adults, and that there were no published studies either on the form of marijuana or other preparations that involved children.

Marijuana is a schedule I controlled substance, so the Food and Drug Administration does not regulate marijuana edibles, resulting in poor labeling and unregulated formulations.²

HighGradeRoots/Thinkstock

Marijuana overdoses can result in cognitive and motor impairment, extreme sedation, agitation, anxiety, cardiac stress, and vomiting. High quantities of THC have been reported to cause transient psychotic symptoms such as hallucinations, delusions, and anxiety.³

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at [email protected].

References

1. “American Academy of Pediatrics Reaffirms Opposition to Legalizing Marijuana for Recreational or Medical Use,” AAP press release on Jan. 26, 2015.

2. N Engl J Med. 2015;372:989-91.

3. Methods Rep RTI Press. 2016 Nov. doi: 10.3768/rtipress.2016.op.0035.1611.

4. JAMA. 2015;313(3):241-2.

5. Pediatrics. 2017 Mar;139(3):e20164069.

“We should not consider marijuana ‘innocent until proven guilty,’ given what we already know about the harms to adolescents,”¹ Sharon Levy, MD, chair of the American Academy of Pediatrics Committee on Substance Abuse, said in an AAP press release, speaking of the legalization of marijuana in Washington and Colorado. The press release was issued in 2015 when the AAP updated its policy on the impact of marijuana policies on youth (Pediatrics. 2015. doi: 10.1542/peds.2014-4146), reaffirming its opposition to legalization of marijuana because it contended that limited studies had been done on “medical marijuana” in adults, and that there were no published studies either on the form of marijuana or other preparations that involved children.

Marijuana is a schedule I controlled substance, so the Food and Drug Administration does not regulate marijuana edibles, resulting in poor labeling and unregulated formulations.²

HighGradeRoots/Thinkstock

Marijuana overdoses can result in cognitive and motor impairment, extreme sedation, agitation, anxiety, cardiac stress, and vomiting. High quantities of THC have been reported to cause transient psychotic symptoms such as hallucinations, delusions, and anxiety.³

Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at [email protected].

References

1. “American Academy of Pediatrics Reaffirms Opposition to Legalizing Marijuana for Recreational or Medical Use,” AAP press release on Jan. 26, 2015.

2. N Engl J Med. 2015;372:989-91.

3. Methods Rep RTI Press. 2016 Nov. doi: 10.3768/rtipress.2016.op.0035.1611.

4. JAMA. 2015;313(3):241-2.

5. Pediatrics. 2017 Mar;139(3):e20164069.

BOSTON – For infants with HIV infection, baseline immune function and birth health appear to influence viral control after the discontinuation of antiretroviral therapy (ART), an analysis of data from the landmark CHER trial shows.

Among 183 children diagnosed with HIV between 6 and 12 weeks of age who were started on early, time-limited ART, longer time to viral rebound after treatment discontinuation was associated with higher baseline CD4 percentages, higher birth weight, and with achievement of viral suppression within 40 weeks of starting on ART, reported Man Chan, PhD, of the Medical Research Council clinical trials unit at University College London.

patrisyu/Thinkstock

The estimated cumulative probability of rebound was 70% at 2 months following ART interruption, 80% at 4 months, 94% at 6 months, and 99% at 8 months.

In multivariable analysis, factors significantly associated with longer time to viral rebound included higher baseline CD4 counts (P = .03), higher birth weight (P = .032), and viral suppression within 40 weeks of starting on ART (P = .028)

In contrast, there were no significant associations with other factors in the multivariate model, including sex, baseline viral load, baseline CD8 percentage, HIV stage, status of therapy to prevent mother-to-child transmission, age at ART initiation, length of therapy, or treatment center.

Sensitivity analyses of a few cases in which there was a 4-7 month gap between rebound and the last viral load below 400 copies/mL before rebound showed similar results, Dr. Chan noted.

The study was the U.S. National Institutes of Health. Dr. Chan reported having nothing to disclose.

SOURCE: Violari A et al. CROI 2018, Abstract 137

BOSTON – For infants with HIV infection, baseline immune function and birth health appear to influence viral control after the discontinuation of antiretroviral therapy (ART), an analysis of data from the landmark CHER trial shows.

Among 183 children diagnosed with HIV between 6 and 12 weeks of age who were started on early, time-limited ART, longer time to viral rebound after treatment discontinuation was associated with higher baseline CD4 percentages, higher birth weight, and with achievement of viral suppression within 40 weeks of starting on ART, reported Man Chan, PhD, of the Medical Research Council clinical trials unit at University College London.

patrisyu/Thinkstock

The estimated cumulative probability of rebound was 70% at 2 months following ART interruption, 80% at 4 months, 94% at 6 months, and 99% at 8 months.

In multivariable analysis, factors significantly associated with longer time to viral rebound included higher baseline CD4 counts (P = .03), higher birth weight (P = .032), and viral suppression within 40 weeks of starting on ART (P = .028)

In contrast, there were no significant associations with other factors in the multivariate model, including sex, baseline viral load, baseline CD8 percentage, HIV stage, status of therapy to prevent mother-to-child transmission, age at ART initiation, length of therapy, or treatment center.

Sensitivity analyses of a few cases in which there was a 4-7 month gap between rebound and the last viral load below 400 copies/mL before rebound showed similar results, Dr. Chan noted.

The study was the U.S. National Institutes of Health. Dr. Chan reported having nothing to disclose.

SOURCE: Violari A et al. CROI 2018, Abstract 137

BOSTON – For infants with HIV infection, baseline immune function and birth health appear to influence viral control after the discontinuation of antiretroviral therapy (ART), an analysis of data from the landmark CHER trial shows.

Among 183 children diagnosed with HIV between 6 and 12 weeks of age who were started on early, time-limited ART, longer time to viral rebound after treatment discontinuation was associated with higher baseline CD4 percentages, higher birth weight, and with achievement of viral suppression within 40 weeks of starting on ART, reported Man Chan, PhD, of the Medical Research Council clinical trials unit at University College London.

patrisyu/Thinkstock

The estimated cumulative probability of rebound was 70% at 2 months following ART interruption, 80% at 4 months, 94% at 6 months, and 99% at 8 months.

In multivariable analysis, factors significantly associated with longer time to viral rebound included higher baseline CD4 counts (P = .03), higher birth weight (P = .032), and viral suppression within 40 weeks of starting on ART (P = .028)

In contrast, there were no significant associations with other factors in the multivariate model, including sex, baseline viral load, baseline CD8 percentage, HIV stage, status of therapy to prevent mother-to-child transmission, age at ART initiation, length of therapy, or treatment center.

Sensitivity analyses of a few cases in which there was a 4-7 month gap between rebound and the last viral load below 400 copies/mL before rebound showed similar results, Dr. Chan noted.

The study was the U.S. National Institutes of Health. Dr. Chan reported having nothing to disclose.

SOURCE: Violari A et al. CROI 2018, Abstract 137

ABSTRACT

This work is a retrospective cohort study evaluating patients who had undergone third-generation cemented total knee arthroplasty (TKA) with prostheses (NexGen, Zimmer Biomet) utilizing posterior-stabilized (PS) and cruciate-retaining (CR) designs at a single center at their 15-year follow-up.

The purpose of this study is to determine the functional knee scores, reoperations, and long-term survivorship for patients with the NexGen Zimmer Biomet Knee system at the 15-year follow-up. In total, 99 patients who had undergone primary TKA were followed for 15 years.

At the 15-year follow-up, survivorship in both study groups was similar: 98% for PS TKAs and 100% for CR TKAs. The 2 groups also showed similar functionality: 80% of the PS implants and 89% of the CR implants were associated with no or mild pain (P = .40). Reoperation rates were 2% for the PS group and 0% for the CR group (P = .38). No differences in any of the outcomes analyzed were observed between patients who had CR TKA and those who had undergone PS TKA.

Our study found no significant differences in functional outcomes between PS and CR NexGen knee implants. Patients treated by both methods showed excellent longevity and survivorship at the 15-year follow-up.

Continue to: Total knee arthroplasty...

Total knee arthroplasty (TKA) is an orthopedic procedure with increasing demand.¹ Over the past 2 decades, a surge in TKA implants has been observed. Of the available prosthetic designs, only a few implants with long-term follow-up have been reported.^2-9 The NexGen TKA system (Zimmer Biomet) has been shown to have excellent clinical and radiographic results at an intermediate follow-up term of 8 years.¹⁰ This system is a third-generation prosthetic design that was developed to improve problems seen with its predecessors, such as the Miller-Galante II system (Zimmer Biomet), the Insall-Burstein II system (Zimmer Biomet), and the Constrained Condylar Knee (Zimmer Biomet), which were mainly for patellar maltracking.^11-17 The NexGen TKA system is a fixed-bearing system designed to include an anatomic femoral trochlea with the option of cruciate-retaining (CR), posterior-stabilized (PS), or more constrained implants. This study evaluates the long-term success of the CR and PS NexGen TKA systems. Outcomes measured include functional knee scores and reoperation rates at the 15-year follow-up. Based on the measured outcomes, potential differences between the PS and CR implants from this system are cited.

MATERIAL AND METHODS

Between July 1995 and July 1997, 334 consecutive primary TKAs were performed on 287 patients at our institution. In total, 167 patients (186 knees) underwent posterior CR TKAs with the NexGen CR prosthesis (Zimmer Biomet), and 120 patients (148 knees) underwent PS TKAs using the NexGen Legacy PS prosthesis (Zimmer Biomet). This retrospective double cohort study was reviewed and approved by our Institutional Review Board. At the 15-year postoperative follow-up, 99 patients were available (Figure 1).

The CR and PS implants were used with similar frequencies by the surgeons who performed the procedures. Patients were not randomized into either the PS- or CR-implant teams; the final decision on implant selection was left to the operating surgeon’s discretion. However, in addition to standard indications for TKA (pain and disability associated with severe arthritic change seen on radiographs and refractory to conservative measures), absolute contraindications to the CR implant included severe combined deformity (flexion contraction >30° combined with a varus or valgus deformity >20°) or posterior cruciate ligament insufficiency (often associated with inflammatory arthritis).

The surgical technique for the CR and PS designs was identical, and included a median parapatellar approach, femoral rotational alignment perpendicular to the transepicondylar axis, measured resection of the flexion and extension gaps, intramedullary femoral alignment, and extramedullary tibial alignment. All components were cemented, and the patella of each patient was resurfaced. All patients received preoperative antibiotics that were continued for 48 hours postoperatively, and 4 weeks of anticoagulation with dose-adjusted warfarin to maintain an international normalized ratio of 1.5 to 2.0.

Patients were observed postoperatively at the 5- to 8-year and 15-year time points. The 5-year data were previously published in 2005 by Bozic and colleagues.¹⁰ Patients available for follow-up at the 15-year time-point were evaluated using the 100-point Hospital for Special Surgery (HSS) knee scoring system, which assigns up to 30 points for pain, 22 points for function, 18 points for range of motion, and 10 points each for quadricep strength, deformity, and instability. In addition, common medical conditions limiting patient activity were assessed; these included joint replacement; arthritis in another joint, the back, or spine; weakness or fatigue; breathing or heart ailments; and others.

Continue to: At the 15-year follow-up...

At the 15-year follow-up, patients were contacted via telephone to obtain their HSS knee scores. If patients were unavailable/unable to answer the questions asked, knee score information was collected from a first-degree relative or caretaker. Patients that could not be contacted by phone were sent a HSS knee score survey to their last known address. The online Social Security Death Index was queried for confirmation of death. If deceased, a first-degree relative was contacted for confirmation.

Survivorship was evaluated using revision for any reason and revision for aseptic loosening as separate endpoints via the Kaplan-Meier product-limit method, and the CR and PS TKA groups were compared using the log-rank test. The power of the study for detecting differences between the TKA groups was determined to be 80%, based on a moderate hazard ratio of 1.5, using the log-rank test. Differences between PS and CR TKAs were assessed using the Pearson chi-square test for knee pain and functional outcomes, Fisher’s exact test for patient limitations, such as joint replacement, and the non-parametric Mann Whitney U-test for median pain scores (Table 1). Spearman correlations between the patients’ self-reported knee scores (as a percentage of normal) and physician-based knee scores were performed to assess whether self-reported knee scores were significantly correlated with physician-based knee scores. Kaplan-Meier analysis was performed to evaluate time-related freedom from reoperation at 95% confidence intervals. Statistical analysis was conducted using IBM SPSS Statistics (version 21.0, IBM). Two-tailed P < .05 was considered statistically significant.

RESULTS

Of the 287 patients (334 knees) who had primary TKAs, 99 patients (121 knees; 75 CR and 46 PS) were available at the 15-year follow-up. A total of 155 patients (171 knees) died before the 15-year follow-up, and 33 (42 knees) were lost to follow-up (Figure 1). The functional status of the knees of patients who were lost to follow-up or who had died since the previous follow-up data were published is unknown.

Demographic and outcome data for the cohort of 121 TKAs (99 patients) are summarized in Table 2. The median age at surgery was 64 years, and 71% of the cohort was female.

At the 15-year follow-up, survivorship in both groups was similar: 98% for PS TKAs and 100% for CR TKAs. The 2 groups were also similar functionally: 80% of the PS implants and 89% of the CR implants were associated with no or mild pain (P = .40). Approximately half of the patients in both groups (52% PS; 50% CR; P = .88) required walking support (canes or walkers) and nearly half of both groups (46% PS; 48% CR; P = .62) could walk <5 blocks or only short distances in their homes. In addition, 46% of the patients in both groups reported needing arm assistance to functionally rise from a chair (P = .43); 91% of the patients in both groups could also walk up and down stairs (P = .77). No statistical difference in the medical conditions limiting the patients in the 2 groups was found: joint replacement (2% PS; 6% CR; P = .71), arthritis in another joint (43% PS; 45% CR; P = .84), back or spine arthritis (31% PS; 33% CR; P = 1.00), weakness or fatigue (24% PS; 25% CR; P = 1.00), breathing or heart ailments (11% PS; 20% CR; P = .40), and other reasons (27% PS; 25% CR; P = 1.00). In addition, median self-reported knee scores were 95 and 93 points for the PS and CR groups, respectively (P = .55).

Continue to: Patients reported 2 complications...

Patients reported 2 complications since the previous 5- to 8-year follow-up, 1 in each group. The first case underwent a PS TKA that required open reduction internal fixation for a bilateral supracondylar peri-prosthesis femur fracture following a fall, which was subsequently complicated with infection and ultimately led to above-the-knee amputation. In the second case, a CR TKA patient experienced persistent swelling and knee instability. The patient followed up with a local orthopaedist, but to date, no reoperations on the knee have been reported.

Spearman correlations between the patients’ self-reported knee scores (as a percentage of normal) and physician-based knee scores were moderately correlated with physician-based knee scores (r_s = 0.42; P < .001).

Reoperation rates were 2% for PS and 0% for CR (P = .38). Kaplan-Meier analysis was performed to evaluate time-related freedom from reoperation and no significance difference between the PS and CR groups was revealed (log-rank test = 1.40, P = .24, Figure 2).

DISCUSSION

The success of TKA in pain relief and restoration of function has led to increased demands for this surgery.¹ Such demand has enabled the introduction of a new joint replacement prosthesis to the market.¹⁸ Considering the increased incidence of osteoarthritis in the younger population (<55 years of age), critically reviewing the longevity and durability of TKA implant designs is of great importance. Compared with other TKA implant designs, the NexGen Zimmer Biomet Knee system has shown excellent longevity at the 15-year follow-up.^5,6,9,11-15 Our study began with 136 patients, and, after eliminating the deceased, those lost to follow-up, and non-responders, a total of 99 patients were available for the 15-year follow-up. At this time-point, 80% of the PS implants and 89% of the CR implants were associated with no or mild pain. Survivorship at the 15-year follow-up was similar in both groups: 98% for PS TKAs and 100% for CR TKAs. The reoperation rate was low in both groups, and no evidence of aseptic loosening was found. Based on our results, the NexGen Zimmer Biomet Knee system can be concluded to show excellent longevity and functional outcomes at the 15-year follow-up.

Our study includes several limiting factors that were taken into consideration during the analysis of the results. One of the main limitations of this work is that it required a 15-year follow-up of predominantly elderly patients; many of the participants may be expected to be deceased at this time-point. In our study, a total of 7 patients were confirmed to be deceased by a first-degree relative or the Social Security Death Index. In addition, unlike Bozic and colleagues’¹⁰ previous 5-year follow-up study, radiographic imaging data were not collected at the 15-year follow-up. However, given that this study aimed to assess the functional knee scores and reoperation rates of the PS and CR NexGen Zimmer Biomet Knee system, radiographic information did not appear to be necessary.

CONCLUSION

This study found no significant differences in functional outcomes between the PS and CR NexGen knee implants. Patients who received these implants showed excellent longevity and survivorship at their 15-year follow-up.

ABSTRACT

This work is a retrospective cohort study evaluating patients who had undergone third-generation cemented total knee arthroplasty (TKA) with prostheses (NexGen, Zimmer Biomet) utilizing posterior-stabilized (PS) and cruciate-retaining (CR) designs at a single center at their 15-year follow-up.

The purpose of this study is to determine the functional knee scores, reoperations, and long-term survivorship for patients with the NexGen Zimmer Biomet Knee system at the 15-year follow-up. In total, 99 patients who had undergone primary TKA were followed for 15 years.

At the 15-year follow-up, survivorship in both study groups was similar: 98% for PS TKAs and 100% for CR TKAs. The 2 groups also showed similar functionality: 80% of the PS implants and 89% of the CR implants were associated with no or mild pain (P = .40). Reoperation rates were 2% for the PS group and 0% for the CR group (P = .38). No differences in any of the outcomes analyzed were observed between patients who had CR TKA and those who had undergone PS TKA.

Our study found no significant differences in functional outcomes between PS and CR NexGen knee implants. Patients treated by both methods showed excellent longevity and survivorship at the 15-year follow-up.

Continue to: Total knee arthroplasty...

Total knee arthroplasty (TKA) is an orthopedic procedure with increasing demand.¹ Over the past 2 decades, a surge in TKA implants has been observed. Of the available prosthetic designs, only a few implants with long-term follow-up have been reported.^2-9 The NexGen TKA system (Zimmer Biomet) has been shown to have excellent clinical and radiographic results at an intermediate follow-up term of 8 years.¹⁰ This system is a third-generation prosthetic design that was developed to improve problems seen with its predecessors, such as the Miller-Galante II system (Zimmer Biomet), the Insall-Burstein II system (Zimmer Biomet), and the Constrained Condylar Knee (Zimmer Biomet), which were mainly for patellar maltracking.^11-17 The NexGen TKA system is a fixed-bearing system designed to include an anatomic femoral trochlea with the option of cruciate-retaining (CR), posterior-stabilized (PS), or more constrained implants. This study evaluates the long-term success of the CR and PS NexGen TKA systems. Outcomes measured include functional knee scores and reoperation rates at the 15-year follow-up. Based on the measured outcomes, potential differences between the PS and CR implants from this system are cited.

MATERIAL AND METHODS

Between July 1995 and July 1997, 334 consecutive primary TKAs were performed on 287 patients at our institution. In total, 167 patients (186 knees) underwent posterior CR TKAs with the NexGen CR prosthesis (Zimmer Biomet), and 120 patients (148 knees) underwent PS TKAs using the NexGen Legacy PS prosthesis (Zimmer Biomet). This retrospective double cohort study was reviewed and approved by our Institutional Review Board. At the 15-year postoperative follow-up, 99 patients were available (Figure 1).

The CR and PS implants were used with similar frequencies by the surgeons who performed the procedures. Patients were not randomized into either the PS- or CR-implant teams; the final decision on implant selection was left to the operating surgeon’s discretion. However, in addition to standard indications for TKA (pain and disability associated with severe arthritic change seen on radiographs and refractory to conservative measures), absolute contraindications to the CR implant included severe combined deformity (flexion contraction >30° combined with a varus or valgus deformity >20°) or posterior cruciate ligament insufficiency (often associated with inflammatory arthritis).

The surgical technique for the CR and PS designs was identical, and included a median parapatellar approach, femoral rotational alignment perpendicular to the transepicondylar axis, measured resection of the flexion and extension gaps, intramedullary femoral alignment, and extramedullary tibial alignment. All components were cemented, and the patella of each patient was resurfaced. All patients received preoperative antibiotics that were continued for 48 hours postoperatively, and 4 weeks of anticoagulation with dose-adjusted warfarin to maintain an international normalized ratio of 1.5 to 2.0.

Patients were observed postoperatively at the 5- to 8-year and 15-year time points. The 5-year data were previously published in 2005 by Bozic and colleagues.¹⁰ Patients available for follow-up at the 15-year time-point were evaluated using the 100-point Hospital for Special Surgery (HSS) knee scoring system, which assigns up to 30 points for pain, 22 points for function, 18 points for range of motion, and 10 points each for quadricep strength, deformity, and instability. In addition, common medical conditions limiting patient activity were assessed; these included joint replacement; arthritis in another joint, the back, or spine; weakness or fatigue; breathing or heart ailments; and others.

Continue to: At the 15-year follow-up...

At the 15-year follow-up, patients were contacted via telephone to obtain their HSS knee scores. If patients were unavailable/unable to answer the questions asked, knee score information was collected from a first-degree relative or caretaker. Patients that could not be contacted by phone were sent a HSS knee score survey to their last known address. The online Social Security Death Index was queried for confirmation of death. If deceased, a first-degree relative was contacted for confirmation.

Survivorship was evaluated using revision for any reason and revision for aseptic loosening as separate endpoints via the Kaplan-Meier product-limit method, and the CR and PS TKA groups were compared using the log-rank test. The power of the study for detecting differences between the TKA groups was determined to be 80%, based on a moderate hazard ratio of 1.5, using the log-rank test. Differences between PS and CR TKAs were assessed using the Pearson chi-square test for knee pain and functional outcomes, Fisher’s exact test for patient limitations, such as joint replacement, and the non-parametric Mann Whitney U-test for median pain scores (Table 1). Spearman correlations between the patients’ self-reported knee scores (as a percentage of normal) and physician-based knee scores were performed to assess whether self-reported knee scores were significantly correlated with physician-based knee scores. Kaplan-Meier analysis was performed to evaluate time-related freedom from reoperation at 95% confidence intervals. Statistical analysis was conducted using IBM SPSS Statistics (version 21.0, IBM). Two-tailed P < .05 was considered statistically significant.

RESULTS

Of the 287 patients (334 knees) who had primary TKAs, 99 patients (121 knees; 75 CR and 46 PS) were available at the 15-year follow-up. A total of 155 patients (171 knees) died before the 15-year follow-up, and 33 (42 knees) were lost to follow-up (Figure 1). The functional status of the knees of patients who were lost to follow-up or who had died since the previous follow-up data were published is unknown.

Demographic and outcome data for the cohort of 121 TKAs (99 patients) are summarized in Table 2. The median age at surgery was 64 years, and 71% of the cohort was female.

At the 15-year follow-up, survivorship in both groups was similar: 98% for PS TKAs and 100% for CR TKAs. The 2 groups were also similar functionally: 80% of the PS implants and 89% of the CR implants were associated with no or mild pain (P = .40). Approximately half of the patients in both groups (52% PS; 50% CR; P = .88) required walking support (canes or walkers) and nearly half of both groups (46% PS; 48% CR; P = .62) could walk <5 blocks or only short distances in their homes. In addition, 46% of the patients in both groups reported needing arm assistance to functionally rise from a chair (P = .43); 91% of the patients in both groups could also walk up and down stairs (P = .77). No statistical difference in the medical conditions limiting the patients in the 2 groups was found: joint replacement (2% PS; 6% CR; P = .71), arthritis in another joint (43% PS; 45% CR; P = .84), back or spine arthritis (31% PS; 33% CR; P = 1.00), weakness or fatigue (24% PS; 25% CR; P = 1.00), breathing or heart ailments (11% PS; 20% CR; P = .40), and other reasons (27% PS; 25% CR; P = 1.00). In addition, median self-reported knee scores were 95 and 93 points for the PS and CR groups, respectively (P = .55).

Continue to: Patients reported 2 complications...

Patients reported 2 complications since the previous 5- to 8-year follow-up, 1 in each group. The first case underwent a PS TKA that required open reduction internal fixation for a bilateral supracondylar peri-prosthesis femur fracture following a fall, which was subsequently complicated with infection and ultimately led to above-the-knee amputation. In the second case, a CR TKA patient experienced persistent swelling and knee instability. The patient followed up with a local orthopaedist, but to date, no reoperations on the knee have been reported.

Spearman correlations between the patients’ self-reported knee scores (as a percentage of normal) and physician-based knee scores were moderately correlated with physician-based knee scores (r_s = 0.42; P < .001).

Reoperation rates were 2% for PS and 0% for CR (P = .38). Kaplan-Meier analysis was performed to evaluate time-related freedom from reoperation and no significance difference between the PS and CR groups was revealed (log-rank test = 1.40, P = .24, Figure 2).

DISCUSSION

The success of TKA in pain relief and restoration of function has led to increased demands for this surgery.¹ Such demand has enabled the introduction of a new joint replacement prosthesis to the market.¹⁸ Considering the increased incidence of osteoarthritis in the younger population (<55 years of age), critically reviewing the longevity and durability of TKA implant designs is of great importance. Compared with other TKA implant designs, the NexGen Zimmer Biomet Knee system has shown excellent longevity at the 15-year follow-up.^5,6,9,11-15 Our study began with 136 patients, and, after eliminating the deceased, those lost to follow-up, and non-responders, a total of 99 patients were available for the 15-year follow-up. At this time-point, 80% of the PS implants and 89% of the CR implants were associated with no or mild pain. Survivorship at the 15-year follow-up was similar in both groups: 98% for PS TKAs and 100% for CR TKAs. The reoperation rate was low in both groups, and no evidence of aseptic loosening was found. Based on our results, the NexGen Zimmer Biomet Knee system can be concluded to show excellent longevity and functional outcomes at the 15-year follow-up.

Our study includes several limiting factors that were taken into consideration during the analysis of the results. One of the main limitations of this work is that it required a 15-year follow-up of predominantly elderly patients; many of the participants may be expected to be deceased at this time-point. In our study, a total of 7 patients were confirmed to be deceased by a first-degree relative or the Social Security Death Index. In addition, unlike Bozic and colleagues’¹⁰ previous 5-year follow-up study, radiographic imaging data were not collected at the 15-year follow-up. However, given that this study aimed to assess the functional knee scores and reoperation rates of the PS and CR NexGen Zimmer Biomet Knee system, radiographic information did not appear to be necessary.

CONCLUSION

This study found no significant differences in functional outcomes between the PS and CR NexGen knee implants. Patients who received these implants showed excellent longevity and survivorship at their 15-year follow-up.

ABSTRACT

This work is a retrospective cohort study evaluating patients who had undergone third-generation cemented total knee arthroplasty (TKA) with prostheses (NexGen, Zimmer Biomet) utilizing posterior-stabilized (PS) and cruciate-retaining (CR) designs at a single center at their 15-year follow-up.

The purpose of this study is to determine the functional knee scores, reoperations, and long-term survivorship for patients with the NexGen Zimmer Biomet Knee system at the 15-year follow-up. In total, 99 patients who had undergone primary TKA were followed for 15 years.

At the 15-year follow-up, survivorship in both study groups was similar: 98% for PS TKAs and 100% for CR TKAs. The 2 groups also showed similar functionality: 80% of the PS implants and 89% of the CR implants were associated with no or mild pain (P = .40). Reoperation rates were 2% for the PS group and 0% for the CR group (P = .38). No differences in any of the outcomes analyzed were observed between patients who had CR TKA and those who had undergone PS TKA.

Our study found no significant differences in functional outcomes between PS and CR NexGen knee implants. Patients treated by both methods showed excellent longevity and survivorship at the 15-year follow-up.

Continue to: Total knee arthroplasty...

Total knee arthroplasty (TKA) is an orthopedic procedure with increasing demand.¹ Over the past 2 decades, a surge in TKA implants has been observed. Of the available prosthetic designs, only a few implants with long-term follow-up have been reported.^2-9 The NexGen TKA system (Zimmer Biomet) has been shown to have excellent clinical and radiographic results at an intermediate follow-up term of 8 years.¹⁰ This system is a third-generation prosthetic design that was developed to improve problems seen with its predecessors, such as the Miller-Galante II system (Zimmer Biomet), the Insall-Burstein II system (Zimmer Biomet), and the Constrained Condylar Knee (Zimmer Biomet), which were mainly for patellar maltracking.^11-17 The NexGen TKA system is a fixed-bearing system designed to include an anatomic femoral trochlea with the option of cruciate-retaining (CR), posterior-stabilized (PS), or more constrained implants. This study evaluates the long-term success of the CR and PS NexGen TKA systems. Outcomes measured include functional knee scores and reoperation rates at the 15-year follow-up. Based on the measured outcomes, potential differences between the PS and CR implants from this system are cited.

MATERIAL AND METHODS

Between July 1995 and July 1997, 334 consecutive primary TKAs were performed on 287 patients at our institution. In total, 167 patients (186 knees) underwent posterior CR TKAs with the NexGen CR prosthesis (Zimmer Biomet), and 120 patients (148 knees) underwent PS TKAs using the NexGen Legacy PS prosthesis (Zimmer Biomet). This retrospective double cohort study was reviewed and approved by our Institutional Review Board. At the 15-year postoperative follow-up, 99 patients were available (Figure 1).

The CR and PS implants were used with similar frequencies by the surgeons who performed the procedures. Patients were not randomized into either the PS- or CR-implant teams; the final decision on implant selection was left to the operating surgeon’s discretion. However, in addition to standard indications for TKA (pain and disability associated with severe arthritic change seen on radiographs and refractory to conservative measures), absolute contraindications to the CR implant included severe combined deformity (flexion contraction >30° combined with a varus or valgus deformity >20°) or posterior cruciate ligament insufficiency (often associated with inflammatory arthritis).

The surgical technique for the CR and PS designs was identical, and included a median parapatellar approach, femoral rotational alignment perpendicular to the transepicondylar axis, measured resection of the flexion and extension gaps, intramedullary femoral alignment, and extramedullary tibial alignment. All components were cemented, and the patella of each patient was resurfaced. All patients received preoperative antibiotics that were continued for 48 hours postoperatively, and 4 weeks of anticoagulation with dose-adjusted warfarin to maintain an international normalized ratio of 1.5 to 2.0.

Patients were observed postoperatively at the 5- to 8-year and 15-year time points. The 5-year data were previously published in 2005 by Bozic and colleagues.¹⁰ Patients available for follow-up at the 15-year time-point were evaluated using the 100-point Hospital for Special Surgery (HSS) knee scoring system, which assigns up to 30 points for pain, 22 points for function, 18 points for range of motion, and 10 points each for quadricep strength, deformity, and instability. In addition, common medical conditions limiting patient activity were assessed; these included joint replacement; arthritis in another joint, the back, or spine; weakness or fatigue; breathing or heart ailments; and others.

Continue to: At the 15-year follow-up...

At the 15-year follow-up, patients were contacted via telephone to obtain their HSS knee scores. If patients were unavailable/unable to answer the questions asked, knee score information was collected from a first-degree relative or caretaker. Patients that could not be contacted by phone were sent a HSS knee score survey to their last known address. The online Social Security Death Index was queried for confirmation of death. If deceased, a first-degree relative was contacted for confirmation.

Survivorship was evaluated using revision for any reason and revision for aseptic loosening as separate endpoints via the Kaplan-Meier product-limit method, and the CR and PS TKA groups were compared using the log-rank test. The power of the study for detecting differences between the TKA groups was determined to be 80%, based on a moderate hazard ratio of 1.5, using the log-rank test. Differences between PS and CR TKAs were assessed using the Pearson chi-square test for knee pain and functional outcomes, Fisher’s exact test for patient limitations, such as joint replacement, and the non-parametric Mann Whitney U-test for median pain scores (Table 1). Spearman correlations between the patients’ self-reported knee scores (as a percentage of normal) and physician-based knee scores were performed to assess whether self-reported knee scores were significantly correlated with physician-based knee scores. Kaplan-Meier analysis was performed to evaluate time-related freedom from reoperation at 95% confidence intervals. Statistical analysis was conducted using IBM SPSS Statistics (version 21.0, IBM). Two-tailed P < .05 was considered statistically significant.

RESULTS

Of the 287 patients (334 knees) who had primary TKAs, 99 patients (121 knees; 75 CR and 46 PS) were available at the 15-year follow-up. A total of 155 patients (171 knees) died before the 15-year follow-up, and 33 (42 knees) were lost to follow-up (Figure 1). The functional status of the knees of patients who were lost to follow-up or who had died since the previous follow-up data were published is unknown.

Demographic and outcome data for the cohort of 121 TKAs (99 patients) are summarized in Table 2. The median age at surgery was 64 years, and 71% of the cohort was female.

At the 15-year follow-up, survivorship in both groups was similar: 98% for PS TKAs and 100% for CR TKAs. The 2 groups were also similar functionally: 80% of the PS implants and 89% of the CR implants were associated with no or mild pain (P = .40). Approximately half of the patients in both groups (52% PS; 50% CR; P = .88) required walking support (canes or walkers) and nearly half of both groups (46% PS; 48% CR; P = .62) could walk <5 blocks or only short distances in their homes. In addition, 46% of the patients in both groups reported needing arm assistance to functionally rise from a chair (P = .43); 91% of the patients in both groups could also walk up and down stairs (P = .77). No statistical difference in the medical conditions limiting the patients in the 2 groups was found: joint replacement (2% PS; 6% CR; P = .71), arthritis in another joint (43% PS; 45% CR; P = .84), back or spine arthritis (31% PS; 33% CR; P = 1.00), weakness or fatigue (24% PS; 25% CR; P = 1.00), breathing or heart ailments (11% PS; 20% CR; P = .40), and other reasons (27% PS; 25% CR; P = 1.00). In addition, median self-reported knee scores were 95 and 93 points for the PS and CR groups, respectively (P = .55).

Continue to: Patients reported 2 complications...

Patients reported 2 complications since the previous 5- to 8-year follow-up, 1 in each group. The first case underwent a PS TKA that required open reduction internal fixation for a bilateral supracondylar peri-prosthesis femur fracture following a fall, which was subsequently complicated with infection and ultimately led to above-the-knee amputation. In the second case, a CR TKA patient experienced persistent swelling and knee instability. The patient followed up with a local orthopaedist, but to date, no reoperations on the knee have been reported.

Spearman correlations between the patients’ self-reported knee scores (as a percentage of normal) and physician-based knee scores were moderately correlated with physician-based knee scores (r_s = 0.42; P < .001).

Reoperation rates were 2% for PS and 0% for CR (P = .38). Kaplan-Meier analysis was performed to evaluate time-related freedom from reoperation and no significance difference between the PS and CR groups was revealed (log-rank test = 1.40, P = .24, Figure 2).

DISCUSSION

The success of TKA in pain relief and restoration of function has led to increased demands for this surgery.¹ Such demand has enabled the introduction of a new joint replacement prosthesis to the market.¹⁸ Considering the increased incidence of osteoarthritis in the younger population (<55 years of age), critically reviewing the longevity and durability of TKA implant designs is of great importance. Compared with other TKA implant designs, the NexGen Zimmer Biomet Knee system has shown excellent longevity at the 15-year follow-up.^5,6,9,11-15 Our study began with 136 patients, and, after eliminating the deceased, those lost to follow-up, and non-responders, a total of 99 patients were available for the 15-year follow-up. At this time-point, 80% of the PS implants and 89% of the CR implants were associated with no or mild pain. Survivorship at the 15-year follow-up was similar in both groups: 98% for PS TKAs and 100% for CR TKAs. The reoperation rate was low in both groups, and no evidence of aseptic loosening was found. Based on our results, the NexGen Zimmer Biomet Knee system can be concluded to show excellent longevity and functional outcomes at the 15-year follow-up.

Our study includes several limiting factors that were taken into consideration during the analysis of the results. One of the main limitations of this work is that it required a 15-year follow-up of predominantly elderly patients; many of the participants may be expected to be deceased at this time-point. In our study, a total of 7 patients were confirmed to be deceased by a first-degree relative or the Social Security Death Index. In addition, unlike Bozic and colleagues’¹⁰ previous 5-year follow-up study, radiographic imaging data were not collected at the 15-year follow-up. However, given that this study aimed to assess the functional knee scores and reoperation rates of the PS and CR NexGen Zimmer Biomet Knee system, radiographic information did not appear to be necessary.

CONCLUSION

This study found no significant differences in functional outcomes between the PS and CR NexGen knee implants. Patients who received these implants showed excellent longevity and survivorship at their 15-year follow-up.