Research within this program evaluates current and innovative devices and device-based interventions in medicine. Collaborating with clinical departments at Weill Cornell Medical College, we aim to provide information and evidence for physicians and patients to facilitate informed clinical decision making. The program has access to number of datasets, such as Medicare, New York State comprehensive discharge data, SEER-Medicare data for various cancer surgeries, and National Surgical Quality Improvement Program data, as well as international registry data for various surgical procedures.
Current research from CBRI focuses on five major areas of clinical medicine: urology, cardiovascular medicine, thoracic surgery, obstetrics & gynecology, and colorectal.
CBRI research in urology focuses on interventions and devices related to treatment of urologic cancers and benign urologic diseases. Comparative studies and patient-centered approaches are used to assess the safety and efficacy of urologic procedures.
Supplemental material for ‘Increase in Prostate Cancer Distant Metastases at Diagnosis in the United States’ (JAMA Oncology) can be found here.
- Chughtai B, Mao J, Buck J, Kaplan S, & Sedrakyan A. Use and risks of surgical mesh for pelvic organ prolapse surgery in women in New York state: population based cohort study. BMJ 2015;350:h2685.[http://www.ncbi.nlm.nih.gov/pubmed/26037077]
Surgical mesh was approved for the repair of pelvic organ prolapse (POP), to reinforce the vaginal wall. In 2008 and 2011, the FDA released a warning against the use of vaginal mesh in POP repair due to reported adverse events. Using the NYS SPARCS database, we found that the use of mesh in POP repair surgery continued to rise even after the 2008 warning. We also found an increase in reintervention in patients who received POP repair with mesh. More specifically, younger patients who received mesh during a pelvic organ prolapse surgery were significantly more likely to require reintervention, while older patients experienced no change in likelihood of reintervention.
- Chughtai B, Simma-Chiang V, Lee R, Isaacs A, Te AE, Kaplan SA, & Sedrakyan A. Trends and utilization of laser prostatectomy in ambulatory surgical procedures for the treatment of benign prostatic hyperplasia in New York State. J Endourol. 2015;29(6):700-706.[http://www.ncbi.nlm.nih.gov/pubmed/25353692]
A number of surgical interventions are available for benign prostatic hyperplasia (BPH), including a variety of minimally invasive surgeries as well as the traditional open option. Using the New York State SPARCS database, the frequencies of use of these many options were analyzed to identify current trends in medical treatment. It was found that the most popular surgical option, transurethral prostatectomy (TURP), despite still maintaining its top spot in BPH treatment, has been decreasing in use while laser methods have been surging to fill the gap, especially in high volume hospitals. Both TURP and laser procedures are safe in terms of complications following surgery.
- Chughtai B, Sedrakyan A, Isaacs A, Lee R, Te A, Kaplan S. Long term safety of sacral nerve modulation in medicare beneficiaries. Neurourol Urodyn. 2015;34(7):659-663.
Sacral nerve stimulation (SNS) is an accepted device-based intervention for an overactive bladder, after behavioral and pharmacological interventions have failed. However, implantation trends still show a high level of variability, suggesting that there is some hesitation about its use. Using Medicare data, SNS patients were identified and analyzed for device safety and efficacy. While day-of-procedure and 90 day complications were not significant, over a quarter of SNS recipients had the device replaced or removed within 5 years, suggesting that this device needs further refinement when it comes to long-term efficacy.
Both traditional open and minimally invasive procedures in cardiovascular practice are of interest in the cardiovascular segment of CBRI research. Patient-centered surgical outcomes and provider level factors in the areas of cardiac valve replacement or repair, abdominal aortic aneurysm, peripheral vascular disease, carotid stenosis, and cerebral aneurysm are being studied.
- Jalbert JJ, Isaacs AJ, Kamel H, & Sedrakyan A. Clipping and Coiling of Unruptured Aneurysms among Medicare Beneficiaries, 2000 to 2010. Stroke. 2015.
Intracranial aneurysms can lead to subarachnoid hemorrhage (SAH)–a dangerous medical condition that has high mortality and a high rate of disability in survivors. Unruptured aneurysms can be managed with a type of minimally invasive procedure of coiling or a more invasive method of clipping. Using Medicare patient records, this study found that between 2000 and 2010, there was a pronounced increase in the number of coiling procedures performed, contributing to an increasing number of patients receiving surgery for intracranial aneurysm. While short-term mortality and complications following both procedures were reduced in the decade, there was no obvious decrease in SAH rate in the overall population.
- Isaacs AJ, Shuhaiber J, Salemi A, Isom OW, & Sedrakyan A. National trends in utilization and in-hospital outcomes of mechanical versus bioprosthetic aortic valve replacements. J Thorac Cardiovasc Surg. 2015;149(5):1262-1269.
There are two primary options for aortic valve replacement in cardiac surgery, mechanical valves and bioprosthetic valves, each of which presents their own postoperative difficulties. Bioprosthetic valves have seen an increase in popularity in recent years, but existing literature comparing the two choices often uses sample sizes too small to see rare outcomes. Using the National Inpatient Sample, this study showed that the type of valve received in surgery varied for patients of different age—older patients were more likely to use bioprosthetic valves. Providers also had variation in choice of valves—low volume providers were more likely to choose mechanical valves. In addition, bioprosthetic valves had significantly lower mortality than mechanical valves in the short-term regardless of age group, although overall complication rates did not differ substantially.
- Salzler GG, Meltzer AJ, Mao J, Isaacs A, Connolly PH, Schneider DB, & Sedrakyan A. Characterizing the evolution of perioperative outcomes and costs of endovascular abdominal aortic aneurysm repair. J Vasc Surg.
Surgery to repair abdominal aortic aneurysm has shifted in recent years from traditional open surgery to a stent-based, minimally invasive procedure called EVAR. It is critical that the results and costs of this popular procedure are tracked as it evolves, to facilitate clinical decision making. EVAR patients were identified using the National Inpatient Sample, and it was found that EVAR procedures from recent years are associated with significantly lower peri-operative mortality and fewer adverse effects after surgery, and that the cost of an EVAR procedure has decreased by over $5,000.
- Paul S, Isaacs AJ, Jalbert J, Osakwe NC, Salemi A, Girardi LN, & Sedrakyan A. A population-based analysis of robotic mitral valve repair. Ann Thorac Surg. 2015;99(5):1546-1653.[http://www.ncbi.nlm.nih.gov/pubmed/25757763]
Recent progress in cardiac medicine has led to the introduction of robotic surgical instruments in an increasing number of mitral valve repair surgeries. Although robotic surgeries still represent a small subset of all mitral valve repairs, it is critical to begin analyzing the safety of the procedure from this early stage. Using the National Inpatient Sample, mitral valve repair patients who received both robotic and traditional surgeries were identified and compared. While there was no significant difference found in the costs of the two procedures, robot-assisted surgery was associated with a significantly shorter hospital stay and acceptable peri-operative mortality and morbidity for patients.
Thoracic Surgery Devices
Research in thoracic surgery is conducted on various topics including pulmonary resection, treatment of lung cancer, etc. Adopted and new technologies used in thoracic procedures are of research interest.
- Paul S, Isaacs AJ, Treasure T, Altorki NK, & Sedrakyan A. Long term survival with thoracoscopic versus open lobectomy: propensity matched comparative analysis using SEER-Medicare database. BMJ 2014;349:g5575.
Removal of afflicted sections of lung tissue, referred to as lobectomy, is considered the first option for lung cancer patients who are able to undergo surgery. Thoracoscopic lobectomy offers a minimally invasive alternative to traditional open surgical methods. In order to gauge if this technology posed any risks to patients beyond those of traditional open surgery, data from the SEER-Medicare database were used to compare lobectomy patients who underwent the two procedures. The study found that thoracoscopic lobectomy poses no additional risks or higher mortality than open surgery, suggesting that it is a very viable minimally-invasive alternative.
- Paul S, Jalbert J, Isaacs AJ, Altorki NK, Isom OW, & Sedrakyan A. Comparative effectiveness of robotic-assisted vs thoracoscopic lobectomy. Chest. 2014;146(6):1505-1512.[http://www.ncbi.nlm.nih.gov/pubmed/24810546]
Robot-assisted surgeries have been introduced in many domains of practice, with little data made available before release and marketing of the new technologies. Lack of training and surgeon unfamiliarity with the equipment could potentially harm patients bodily, while higher costs can increase the already substantial financial burden of these procedures. Data from the National Inpatient Sample were used to identify patients who received either robot-assisted lobectomy or another minimally invasive option, thoracoscopic lobectomy. It was found that the robot-assisted surgery offered no significant advantage over the thoracoscopic procedure, while increasing the risk of injury and bleeding during surgery and costing substantially more per procedure.
Research in OB-GYN assesses device safety and efficacy in treatment of tumors and benign conditions. Development in minimally invasive technology and its use in OB-GYN is one of the most important areas of interest in OB-GYN research
- Mao J, Pfeifer S, Zheng XE, Schlegel P, & Sedrakyan A. Population-based estimates of the prevalence of uterine sarcoma among patients with leiomyomata undergoing surgical treatment. JAMA surg. 2015;150(4):368-70.
Uterine fibroids are one of the most common benign gynecologic diseases among women. As an alternative to traditional open surgery, a minimally invasive approach using electric morcellation has been performed on selected cases. However, due to the concern of spreading unsuspected uterine sarcoma within the body, the FDA discouraged the use of morcellators in treating uterine fibroids in 2014. This study, using the California state database and the SEER cancer registry, estimated the overall prevalence of unsuspected uterine sarcoma among women with uterine fibroids undergoing surgery is 0.17% to 0.30%. Prevalence was higher for women over the age of 60. This study also evaluated the risks of mortality and major complications following open fibroids resection and found some evidence of risks depending on age, suggesting that a benefit and harm discussion should be carried out between the physician and patient before surgery.
- Mao J, Pfeifer S, Schlegel P, & Sedrakyan A. Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study. BMJ 2015;351:h5162.
Female sterilization is one of the most commonly used methods of contraception, and is traditionally performed via laparoscopy to ligate fallopian tubes of both sides. Since the introduction of the Essure device 12 years ago, interval sterilization can be also performed by inserting the device with hysteroscopy. With the increasing use of Essure, there have been reports to the FDA of adverse events, and the efficacy has also been questioned. The present study compared the safety and efficacy of Essure-based hysteroscopic sterilization to the traditional laparoscopic procedure. Short-term adverse events following both procedures were rare. Hysteroscopic and laparoscopic sterilization also had similar risks of unintended pregnancy following surgery. However, the Essure procedure was associated with a 10 times higher risk of reoperation within the first year following surgery.
- Sedrakyan A, Chughtai B, & Mao J. Regulatory warnings and use of surgical mesh in pelvic organ prolapse. JAMA Intern Med. 2015.
In 2008, the FDA released a warning about the use of transvaginal mesh in pelvic organ prolapse repair procedures, advising all surgeons to seek special training in mesh implantation before using it in their own practice. A second warning was released in 2011 describing complications following mesh implantation as “not rare” and suggesting non-mesh pelvic organ prolapse repairs. This study used the New York State SPARCS database to look at trends in transvaginal mesh use since the second FDA warning in 2011. Use of mesh in pelvic organ prolapse repair decreased from a 30% rate of use in 2011 to a 23% rate of use in 2013, reflecting a change in practice in response to the second FDA warning, and a total of 22 physicians ceased mesh use altogether.
Abdominal and Gastrointestinal Devices
CBRI research in abdominal and gastrointestinal surgery focuses on interventions and devices related to the treatment of colorectal cancer and benign conditions. Comparative studies covering a wide range of surgical technologies such as robotics and laparoscopic technologies, endoscopes and stents are conducted. We assess safety, efficacy and effectiveness of these technologies and interventions using big data and primary clinical data sources.
- Yeo HL, Isaacs AJ, Abelson JS, Milsom JW, Sedrakyan A. Comparison of Open, Laparoscopic, and Robotic Colectomies Using a Large National Database: Outcomes and Trends Related to Surgery Center Volume. Dis Colon Rectum. 2016 Jun;59(6):535-42. doi: 10.1097/DCR.0000000000000580. PubMed PMID: 27145311.
This study investigated adoption trends of laparoscopic and robotic elective colectomy as compared to open surgery, and the interactions between surgery type and hospital volume. While the majority of elective colectomies were still being performed using open surgery methods, usage rates of laparoscopic surgery were increasing steadily, especially in high-volume centers. Overall, the majority of laparoscopic and robotic surgeries were performed at high-volume centers, and were associated with lower average lengths of stay than open surgery. However, this study also found that robotic surgery came with an increased rate of iatrogenic complications, as well as higher costs when compared to laparoscopic surgery. As minimally invasive methods continue to be adopted, complication rates and usage patterns are of critical importance to understanding the state of colorectal surgery.
- Yeo HL, Abelson JS, Mao J, Cheerharan M, Milsom J, Sedrakyan A. Minimally invasive surgery and sphincter preservation in rectal cancer. J Surg Res. 2016 May 15;202(2):299-307. doi: 10.1016/j.jss.2016.01.010. PubMed PMID: 27229104.
In recent years, rectal cancer treatment options have broadened to include sphincter-preserving surgeries (SPS) as well as minimally-invasive surgical options (MIS). This shift in the treatment landscape has been most pronounced in larger-volume centers. Using the National Inpatient Sample, this study sought to take a closer look at the relationship between SPS and MIS usage and hospital volume. There was an increase in cases performed at high volume centers, with the growing use of abdominal perineal resection (APR). In addition, perioperative outcomes for MIS/open surgery and SPS/non-SPS were compared. Perioperative outcomes for MIS were also found to be better than those for open surgery, such as a shorter length of stay and a lower incidence of wound complications.
- Abelson JS, Yeo HL, Mao J, Milsom JW, Sedrakyan A. Long-term Postprocedural Outcomes of Palliative Emergency Stenting vs Stoma in Malignant Large-Bowel Obstruction. JAMA Surgery. Published online January 11, 2017. doi:10.1001/jamasurg.2016.5043. PubMed PMID: 28097296.
This study investigated readmission, reoperation, and other outcomes following palliative stent or stoma operation for bowel obstruction due to colorectal cancer in New York State, both in-hospital and long-term (90 days and 1 year). It was found that patients living closer to high-volume centers were more likely to undergo a stenting procedure. Patients who underwent stenting had lower rates of in-hospital death and of procedural complications than those who underwent stoma creation. Patients who received stents also had a shorter average length of stay and were less likely to be discharged to a nursing or rehabilitation facility. However, patients undergoing stenting were more likely to receive another procedure in the following year, mostly a re-stenting procedure. Stenting is safe in patients who are to receive only palliative treatment for bowel obstruction when offered at high volume hospitals. Patients should be cautioned that they might receive another stenting in the following year.