Surgery News - December 2008 - (Page 12) THORACIC SURGERY NEWS • D E C E M B E R 2 0 0 8 FDA Approves Bronchial Valve for Postop Air Leaks B Y E L I Z A B E T H M E C H C AT I E Else vier Global Medical Ne ws n implantable bronchial valve designed to control prolonged air leaks of the lung after lobectomy, segmentectomy, or lung volume reduction surgery has been approved by the Food and Drug Administration. The IBV Valve System includes the valve, a catheter for inserting it, and a sizing kit to measure the target area for valve implantation, according to the FDA statement announcing the approval. The system is used to treat patients “who have undergone partial or total removal of a lung lobe or lung volume reduction surgery and who experience prolonged air leaks [present 7 days after surgery] or significant air leaks that may become prolonged,” the FDA said. The catheter containing the valve is passed through a bronchoscope, and the valve is then placed in the affected area of the lung, where it self-expands and redirects air flow from the diseased regions while allowing secre- Correction In the Point/Counterpoint “Is the Joint Commission’s MS 1.20 a step in the right direction?” (October 2008, p. 6), the photos of the two authors were inadvertently switched. Dr. J. James Rohack’s photo should have appeared with the discussion on the left of the page, and Mr. James Castle’s should have appeared with the discussion on the right. tions and trapped air to pass through, according to Spiration Inc., the manufacturer. The valve expands and contracts with breathing and can be removed during a bronchoscopy. The valve was approved under the Humanitarian Device Exemption program, which applies to devices for diseases or conditions that affect fewer than 4,000 people in the United States every year. Approval was based on successful use of the valve in 58 patients with emphysema and 4 patients with prolonged air leaks, according to Spiration. The company plans to conduct a postapproval safety and efficacy study. The valve is currently being studied in a trial of U.S. patients with severe emphysema. Patients The IBV is placed in the affected area of the lung, where it aged 40-70 years with predominantly upper lobe self-expands and redirects airflow from the diseased regions. emphysema and shortness of breath with exertion who have had inadequate responses to available medical studies have shown that “in properly selected patients, treatments and who are either ineligible for or opposed these one-way valves, which can be easily placed via a to invasive surgery are being enrolled in the trial, ac- bronchoscope and which block the entry of air into emcording to Spiration. The study is comparing response physematous segments of the lung but allowed for murates and serious adverse events at 6 months among those cus exit, improve the breathlessness these patients expewho have the valve implanted and controls, who under- rience.” Among them are several presented in May 2008 go a diagnostic bronchoscopy with no valves implanted. at the American Thoracic Society meeting in Toronto. “Although the mechanism of action is different than The approval “is an extremely important step for patients with emphysema,” said Dr. Robert James Cerfolio, that seen in lung volume reduction surgery, the imFACS, FCCP, professor of surgery and chief of the sec- provement in dyspnea in these patients may be just as tion of thoracic surgery at the University of Alabama at good,” Dr. Cerfolio noted, adding that the technique enBirmingham, who has significant experience with these tails a 15- to 20-minute bronchoscopy, and thereby avoids the morbidity associated with surgery. Dr. Cerfolio is an valves. He said in an interview that several well-designed investigator in a study of the device. ■ Robotically Assisted CABG Found Financially Viable vein grafts. Bilateral mammary artery grafts weren’t taken through the sternotomy incision because these were high-risk patients who were believed to be unlikeN E W YO R K — Robotically assisted minimally invasive ly to do well under those circumstances. The same surgeon operated on all 200 subjects, most coronary artery bypass graft surgery proved cost equivalent to conventional off-pump sternotomy CABG in a of whom had triple-vessel disease. Diabetes and chronic lung disease were highly prevalent. About 20% of patients 200-patient prospective study with 1 year of follow-up. This finding debunks widely repeated claims that ro- in each study arm had a left ventricular ejection fraction botically assisted minimally invasive CABG (miniCABG), below 35%. Robotic harvesting of both internal mammary arterwith its steep high-tech equipment costs, is not financially viable, Dr. Robert S. Poston Jr. said at the annual meet- ies through a small incision is tedious and requires a significantly longer mean operating room time ing of the American Surgical Association. than is needed for sternotomy CABG. The In fact, in the highest-risk patient subset— miniCABG group also had increased expensthose who ranked preoperatively as class 4 es for single-use robotic instruments and coroDRG (diagnosis-related groups) severity— nary stents. However, the sternotomy CABG profit margins were 65% greater with minigroup had longer intubation times, a higher CABG than with sternotomy CABG. number of transfusions, and greater hospital Hospital reimbursement for CABG in such length of stay. patients is about $80,000. With miniCABG, Moreover, the 1-year rate of major adverse that resulted in a profit margin of close to cardiovascular events—death, myocardial in$25,000 per class 4 severity patient, according farction, stroke, or target vessel occlusion— to Dr. Poston, a cardiothoracic surgeon at the The sternotomy was 4% in the miniCABG group, compared University of Maryland, Baltimore. That’s CABG group had with 26% in the sternotomy group. This because postoperative complications such as longer intubation increased ventilator time, length of hospital times and hospital marked difference in major outcomes was driven largely by significantly better target vessel stay, and transfusions occur less often with stays than the graft patency in the miniCABG group as asminiCABG—and patients who are DRG class miniCABG group. sessed by CT angiography at 12 months. The 4 severity are at greatest risk for such comDR. POSTON saphenous vein grafts used in conjunction plications, he said. In this study, 100 consecutive patients underwent mini- with sternotomy CABG had a high failure rate. Patients in the miniCABG group were more satisfied CABG with robotic harvesting of both left and right internal mammary arteries for grafting purposes through than those in the other group; 80% of miniCABG patients a small thoracotomy incision in the left chest. In each rated their experience a 6 on a 1-6 scale. Half as many stercase, the right internal mammary artery graft was placed notomy CABG patients did so. In addition, return to work on the left anterior descending coronary artery and the came a mean of 2 months earlier in the miniCABG left internal mammary graft was taken to a lateral wall group. “Most of the previous research on minimally invasive target. This form of miniCABG is a hybrid procedure in CABG has been done in highly selected low-risk patients. which coronary stents were used elsewhere as needed. The control group of 100 patients, who had an equiv- A novel finding in our study is that miniCABG can be apalent number of target coronary arteries and disease plied safely to high-risk patients, and in fact there may be severity scores, underwent sternotomy and off-pump some important advantages of that application,” he said. While agreeing that the study demonstrates the feasiCABG using left internal mammary artery and saphenous BY BRUCE JANCIN Else vier Global Medical Ne ws bility of a robotically assisted hybrid CABG for high-risk patients, Dr. Fred Crawford pointed out that no data were provided to indicate how patients were selected for RA versus sternotomy-assisted CABG. “Saphenous veins were used for conduits in the sternotomy group, and only arterial grafts were used in the RA group, and therefore it’s not surprising that graft patency was superior in the RA group,” said Dr. Crawford, an ACS Fellow and chief of the division of cardiothoracic surgery at the Medical University of South Carolina, who commented on the study. Dr. Gus J. Vlahakes, an ACS Fellow and professor of surgery at Harvard Medical School, Boston, who was a discussant at the meeting, noted that Dr. Poston hadn’t figured in the expense of acquiring the da Vinci robot in his cost analysis. Dr. Poston replied that because the robot is also used by other surgical services, the burden of amortizing the cost of the device shouldn’t be borne solely by cardiothoracic surgery. When asked whether any special pain management strategies are required in miniCABG patients, Dr. Poston said he uses intercostal nerve blocks, an On-Q pain pump with insertion of a catheter into the wound in order to continuously irrigate it with bupivacaine, or a high thoracic epidural. Because the ribs are heavily innervated, thoracotomy is a more painful incision than sternotomy, but the pain resolves much faster, Dr. Poston said. The miniCABG patients stopped their pain medications in about 2 weeks, compared with 6 weeks in the sternotomy group. Dr. Poston said his study showing that miniCABG is cost equivalent to conventional CABG answers the sole remaining major question raised by critics. “This study provides additional data about the usefulness of the robot in cardiac surgery [but] caution must be utilized especially by the lay public in interpreting this and other similar data, as this procedure is clearly not applicable to all or even the majority of patients currently undergoing myocardial revascularization,” Dr. Crawford noted. Dr. Poston declared having no financial conflicts of interest with regard to this study. ■ ©SPIRATION, INC.
Table of Contents Feed for the Digital Edition of Surgery News - December 2008 Surgery News - December 2008 Contents The 20/20 Vision: Health Reform News From the College: Nominations Thoracic: Breathing Easier Postop Management: Renal Failure Surgery News - December 2008 Surgery News - December 2008 - Contents (Page 1) Surgery News - December 2008 - Contents (Page 2) Surgery News - December 2008 - Contents (Page 3) Surgery News - December 2008 - Contents (Page 4) Surgery News - December 2008 - Contents (Page 5) Surgery News - December 2008 - The 20/20 Vision: Health Reform (Page 6) Surgery News - December 2008 - The 20/20 Vision: Health Reform (Page 7) Surgery News - December 2008 - The 20/20 Vision: Health Reform (Page 8) Surgery News - December 2008 - The 20/20 Vision: Health Reform (Page 9) Surgery News - December 2008 - News From the College: Nominations (Page 10) Surgery News - December 2008 - News From the College: Nominations (Page 11) Surgery News - December 2008 - Thoracic: Breathing Easier (Page 12) Surgery News - December 2008 - Thoracic: Breathing Easier (Page 13) Surgery News - December 2008 - Thoracic: Breathing Easier (Page 14) Surgery News - December 2008 - Thoracic: Breathing Easier (Page 15) Surgery News - December 2008 - Postop Management: Renal Failure (Page 16) Surgery News - December 2008 - Postop Management: Renal Failure (Page 17) Surgery News - December 2008 - Postop Management: Renal Failure (Page 18) Surgery News - December 2008 - Postop Management: Renal Failure (Page 19) Surgery News - December 2008 - Postop Management: Renal Failure (Page 20)
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